As filed with the Securities and Exchange Commission on August 10, 2022

Registration No. 333-265817

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Amendment No. 1

to

FORM S-1

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

IMMUNOCELLULAR THERAPEUTICS, LTD.*

(Exact name of registrant as specified in its charter)

Delaware	2834	93-1301885
(State or other jurisdiction of	(Primary Standard Industrial	(I.R.S. Employer
incorporation or organization)	Classification Code Number)	Identification Number)

136 Summit Avenue

Montvale, NJ 07645

Telephone: (201) 351-0605

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Eli Goldberger

Chairman and Chief Operating Officer

136 Summit Avenue

Montvale, NJ 07645

Telephone: (201) 351-0605

(Name, address, including zip code, and telephone number, including area code, of agent for service)

With copies to:

Louis A. Brilleman, Esq. 1140 Avenue of the Americas, 9^th Floor New York, NY 10036 (212) 537-5852 Jeffrey Fessler, Esq. Sheppard, Mullin, Richter & Hampton LLP 30 Rockefeller Plaza New York, NY 10112 (212) 653-8700

Approximate date of commencement of proposed sale to the public:

As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box: ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to section 8(a), may determine.

* ImmunoCellular Therapeutics, Ltd. is the registrant filing this registration statement with the Securities and Exchange Commission. Prior to the closing of this offering, the registrant will undergo a name change to EOM Pharmaceutical Holdings, Inc.

The information in this prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS SUBJECT TO COMPLETION DATED __________, 2022

EOM PHARMACEUTICAL HOLDINGS, INC.

____________ Shares of Common Stock

This is a firm commitment underwritten public offering of common stock, par value $0.0001 per share (“Common Stock”) of EOM Pharmaceuticals Holdings, Inc., a Delaware corporation. We expect the public offering price of our Common Stock to be between $____ and $____ per share.

Our Common Stock is currently traded on the Pink Sheets of the OTC Markets under the symbol “IMUC.” As of August 9, 2022, the reported closing price of our Common Stock as quoted on the Pink Sheets was $0.54 per share.

We have applied to list our Common Stock on The Nasdaq Capital Market under the symbol “EOM.”

The offering price of the Common Stock will be determined between us and EF Hutton, division of Benchmark Investments, LLC, the representative of the underwriters in connection with this offering, taking into consideration our historical performance and capital structure, prevailing market conditions, and overall assessment of our business, and will not be based upon the price of our common stock on the Pink Sheets of the OTC. Therefore, the assumed public offering price of the Common Stock used throughout this prospectus may not be indicative of the actual public offering price for our Common Stock.

Investing in our securities involves a high degree of risk. Before buying any of our securities, you should carefully read the discussion of the material risks of investing in our securities under the heading “Risk Factors” beginning on page 11 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

	Per Share	Total
Public offering price	$	$
Underwriting discounts and commissions (1)	$	$
Proceeds to us, before expenses	$	$

(1) We refer you to “Underwriting” beginning on page 97 of this prospectus for additional information regarding underwriting compensation.

We have granted the underwriters a 45-day option to purchase up to ____ additional shares, solely to cover over-allotments, if any (the “Over-Allotment Option”). If the underwriters exercise the Over-Allotment Option in full, the total underwriting discounts payable by us will be $_____ and the total proceeds to us, before expenses, will be $ ______.

The underwriters expect to deliver the securities against payment to the investors in this offering on or about _____, 2022.

Sole Book-Running Manager

EF HUTTON

division of Benchmark Investments, LLC

The date of this prospectus is ____________, 2022

TABLE OF CONTENTS

	Page
Prospectus Summary	3
Risk Factors	11
Cautionary Note Regarding Forward-Looking Statements and Industry Data	46
Use of Proceeds	47
Dividend Policy	48
Capitalization	49
Dilution	50
Management’s Discussion and Analysis of Financial Condition and Results of Operations	51
Business	61
Management	85
Executive Compensation	90
Certain Relationships and Related Party Transactions	92
Security Ownership of Certain Beneficial Owners and Management	93
Description of Securities	94
Underwriting	97
Experts	105
Legal Matters	105
Where You Can Find More Information	105
Glossary of Terms	106
Index to Financial Statements	F-1

You should rely only on the information contained in this prospectus or in any free writing prospectus that we may specifically authorize to be delivered or made available to you. We have not authorized anyone to provide you with any information other than that contained in this prospectus or in any free writing prospectus we may authorize to be delivered or made available to you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus may only be used where it is legal to offer and sell our securities. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date. We are not making an offer of these securities in any jurisdiction where the offer is not permitted.

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PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before investing in our Common Stock, you should carefully read this entire prospectus, including our financial statements and the related notes and the information set forth under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in each case included elsewhere in this prospectus.

Unless the context otherwise requires, references to “we,” “our,” “us,” in this prospectus mean EOM Pharmaceuticals Holdings, Inc., Inc., a Delaware corporation, and its wholly owned subsidiary, EOM Pharmaceuticals, Inc.

Our Company

We are a clinical-stage pharmaceutical company focused on the development of novel therapeutics and delivery technologies for the treatment of inflammatory conditions and ocular diseases. Our development pipeline consists of multiple programs and clinical indications at various stages of development. Our portfolio currently consists of two product candidates: EOM613 and EOM147.

EOM613

EOM613 is an investigational, dynamically dual-acting immunomodulator. EOM613 is a peptide-nucleic acid solution and, based on past clinical data published by third parties, is believed to have both an anti-inflammatory and pro-inflammatory effect at the site of cytokine and chemokine overactivity, and a pro-inflammatory effect when needed. EOM is designed to counteract the most severe inflammatory effects of viruses, such as a cytokine storm or hyperimmune response following infection with the novel coronavirus that cause COVID-19, autoimmune attacks that cause joint damage and pain associated with rheumatoid arthritis and gastrointestinal disorders, and chemokine-related body-wasting syndromes such as cachexia. In human cell culture studies, EOM613 demonstrated a “dynamic dual action” by suppressing or stimulating monocytes and macrophages depending on the activation state and environment of those key immune cells. We believe that this dynamic dual action may overcome a limitation of many approved immunomodulators that only reduce the inflammatory state, without achieving total immune system balance. EOM613 has a development program as supported by multiple exploratory previous clinical stage data across multiple therapeutic applications associated with hyperimmune responses, including cachexia associated with HIV/AIDS or cancer and rheumatoid arthritis. The current open-label trial for COVID-19 in Brazil for EOM613 meets the regulatory Phase 1/2a clinical trial requirements of the Comissao Nacional de Etica em Pesquisa and the Brazilian regulatory body ANVISA. However, additional, larger Phase 2 placebo-controlled trials will be required for the further clinical development of EOM613 in the United States.

Our operating subsidiary, EOM Pharmaceuticals, Inc., commenced its current operations in March 2020. Since that date, we have been conducting a clinical trial in Brazil, as well as pre-clinical animal studies. We have also been performing additional research and development through contract research organizations for both our product candidates EOM613 and EOM147. In addition, we have been seeking sources of additional capital to further our research and development efforts along with future clinical trials.

We believe that EOM613 may be used as a therapy for the following diseases:

Severe Effects of Infectious Disease, Including COVID-19

COVID-19 is a highly infectious and potentially fatal disease. According to WHO, as of June 17, 2022, it has caused over 6.3 million deaths and over 500 million cases worldwide. Research shows that cytokine storms are highly correlated with mortality in COVID-19. Aggressive inflammatory responses such as cytokine storms can lead to acute respiratory distress syndrome (ARDS), which is a cause of death in 70% of fatal COVID-9 cases.

Chemokine-Related Body Wasting Syndromes: Cancer Cachexia

Cachexia is a wasting syndrome that causes loss of weight, body fat, muscle mass, and appetite due to a chronic disease, such as cancer. It results in weakness, fatigue, malnourishment, and can be life-threatening. It is caused principally by chemotherapy and radiation treatments. Cancer cachexia affects approximately 50% of all cancer patients. Cancer cachexia is caused by a combination of decreased nutritional intake and altered metabolism and is defined as ongoing loss of skeletal muscle mass that cannot be reversed by conventional nutritional support. It is characterized by progressive functional impairment and contributes to more than 20% of cancer deaths. Since around 50% of patients with malignant disease cannot be cured and more than 80% of advanced cancer patients experience cachexia, the toll of this condition is severe both for society and the individual patient. The pathogenesis of cancer cachexia is highly dependent on the patient’s immune response. Inflammatory cytokines and pro-cachectic factors induce muscle degradation even in the face of adequate nutrition. The prevalence of cachexia is as high as 87% in patients with pancreatic and gastric cancer, 61% in patients with colon, lung, and prostate cancer and non-Hodgkin lymphoma, and 40% in breast cancer, sarcoma, leukemia, and Hodgkin lymphoma. There are no approved cancer cachexia therapies.

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Autoimmune Diseases: Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a debilitating chronic autoimmune disease that affects the joints, connective tissues, muscle, tendons, and fibrous tissue, and causes pain and deformity. The World Health Organization estimates that more than 23 million people, mostly women, live with RA.

EOM147

EOM 147 is an investigational, broad-spectrum aminosterol with a novel intracellular mechanism for the treatment of retinal diseases. Based on prior clinical data, we believe that EOM147 can affect multiple angiogenic growth factors such as VEGF, PDGF, and bFGF. This mechanism of action is differentiated from other retinal therapies that are only anti-VEGF and administered as an intraocular injection. The novel formulation, administered as an eye drop, represents a potential breakthrough that does not require intraocular injection. EOM147 is being developed as a proprietary, newly reformulated eye drop, containing a steroid-polyamine conjugate compound with broad-spectrum antimicrobial activity and anti-angiogenic activity. We believe that EOM147 may be used as therapy for retinal diseases, including retinal tear, retinal detachment, diabetic retinopathy, epiretinal membrane, macular hole, macular degeneration, and retinitis pigmentosa, all of which affect the vital tissue of the eye and can lead to blindness.

Age-Related Macular Degeneration (AMD)

Age-related macular degeneration is an eye disease that can blur the sharp, central vision needed for activities like reading and driving. “Age-related” means that it often happens in older people. “Macular” means it affects a part of the eye within the retina called the macula. AMD is a common condition and a leading cause of vision loss for people age 50 and older. Although AMD does not necessarily cause complete blindness, it does impact central vision that can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The National Eye Institute estimates that by 2050, the number of people with AMD in the U.S. is expected to double from 2.07 million (2010) to 5.44 million. According to the Bright Focus Foundation, the number of people living with some form of macular degeneration is expected to reach 196 million worldwide by 2020 and increase to 288 million by 2050. There is no current therapeutic treatment for dry macular degeneration, but certain vitamin and mineral supplements may delay progression of the disease. Wet macular degeneration is often treated by eye injections of anti-VEGF medicines, which inhibit the abnormal growth of blood vessels. A type of laser treatment called photodynamic therapy also can be used to help break down the extra blood vessels in the back of the eye.

Diabetic Retinopathy (DR):

Diabetes is the leading cause of new cases of blindness in adults. About 1 in 3 people with diabetes have Diabetic Retinopathy, affecting almost one-third of adults over age 40 years with diabetes, and more than one-third of African-Americans and Mexican Americans. According to the Centers for Disease Control and Prevention, diabetic retinopathy affects 7.7 million Americans, and that number is projected to increase to more than 14.6 million people by 2030. The most common diabetic eye disease and a leading cause of blindness in American adults, diabetic retinopathy is caused by changes in the blood vessels of the retina due to excess sugar in the bloodstream. Currently, diabetic retinopathy is typically treated by shrinking abnormal blood vessels in the eye with laser therapy, by surgically evacuating and replacing fluid in the eye (vitrectomy), or by injecting anti-VEGF medicines into the eye.

Retinal Vein Occlusions (RVOs)

Retinal vein occlusions are blockages of the small veins that carry blood away from the retina. Such compromised blood flow can cause reduction in blood flow, causing sudden blurred vision and blind spots in the center of one’s visual field. The persistent build-up of blood in the retina, particularly in the macular area can cause substantial vision loss. Retinal vein occlusions are of two types- central retinal vein occlusions (CRVOs), which are caused by the blockage of the main retinal vein, and branch retinal vein occlusions (BRVOs), which affect one or more of the smaller branch veins from the main retinal vein. There is no current cure for retinal vein occlusions; laser treatment or repeated treatments with intravitreally injected anti-VEGF agents is most often used in the treatment in order to reduce the levels of macular edema. An estimated 20 million or more people currently suffer from RVOs worldwide.

We have generated no revenues, have incurred operating losses since inception, and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. For the three-months ended March 31, 2022 and for the year ended December 31, 2021, we incurred net losses from operations of approximately $800,000 and $2,600,000, respectively. In addition, for the three-months ended March 31, 2022 and for the year ended December 31, 2021 we incurred negative cash flows from operating activities of approximately $600,000 and $2,300,000 respectively. We expect to incur substantial losses for the foreseeable future, which will continue to generate negative net cash flows from operating activities, as we continue to pursue research and development activities and the pre-clinical and clinical development of our primary product candidates, EOM613 and EOM147. As of March 31, 2022, we had cash of $933,148, working capital (defined as current assets less current liabilities) of $374,531 and an accumulated deficit in shareholders’ equity of $(7,387,302). The Company’s primary sources of cash have included a bridge note facility and the issuance of convertible debt to one of our largest stockholders and the issuance of founder shares.

These factors, among others including the lengthy and costly drug development and regulatory approval process, raise substantial doubt as to our ability to obtain additional debt or equity financing and our ability to continue as a going concern as described in the footnotes to our March 31, 2022 unaudited interim condensed consolidated financial statements. Until such time as we are able to establish a revenue stream from the sale of our therapeutic products, we are dependent upon obtaining necessary equity and/or debt financing to continue operations. We cannot make any assurances that sales of our drug products will commence in the near term or that additional financings will be available to us and, if available, on acceptable terms or at all.

To date, we have been funded entirely by the family of Eli Goldberger, our Chairman and Chief Operating Officer, through a Bridge Note Facility in the amount of approximately $1.5 million and the issuance of a Convertible Promissory Note in the amount of up to $5 million. To date, Mr. Goldberger’s father has loaned us $2,501,399 through these two instruments. Under the terms of the Convertible Promissory Note, we have the right to prepay up to 25% of the principal amount of the outstanding balance in the event we receive gross proceeds of no less than $10 million from the sale of our common stock. We intend to repay approximately $675,000 out of the net proceeds of this offering.

There can be no assurance that the Goldberger family will continue to fund our operations on favorable terms or at all. Moreover, there can be no assurance that we will be able to secure the necessary third-party debt or equity financings to continue our drug development, pre-clinical and clinical trial plans at all or on terms acceptable to us. This could negatively impact our business and operations and could also lead to the reduction of our business and drug development operations.

We intend to raise such additional capital through a combination of private and public equity offerings, debt financings, government funding arrangements, strategic alliances or other sources. However, if such financing is not available at adequate levels and on a timely basis, or such agreements are not available on favorable terms, or at all, as and when needed, we will need to reevaluate our operating plan and may be required to delay or discontinue the development of one or more of our product candidates or operational initiatives. We expect that our cash as of March 31, 2022 will be insufficient to fund our projected operations for the next twelve months and accordingly, we are in the process of attempting to raise additional equity and/or debt funds to continue our operations through the end of 2022 and beyond.

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Our Competitive Strengths

We believe that we possess a number of competitive strengths that position us to become a leading biopharmaceutical company focused on inflammatory and immune-related diseases as well as retinal diseases, including:

● Our technology and drug development capabilities. EOM613 and predecessor formulations have been explored in several human studies and have shown potential in the treatment of diseases such as rheumatoid arthritis. The present Phase 1/2a study in COVID-19 patients in Brazil is generating important information on cytokines and the effect of EOM613 treatment on the levels of these cytokines and the relevance to clinical effects. This information will increase our knowledge of EOM613’s Mechanism of Acton and the relevance to various therapeutic areas. However, additional, larger Phase 2 placebo-controlled trials will be required for the further clinical development of EOM613 in the United States. EOM147 represents a different and potentially safer mode of application of well accepted VEGF type treatments for Age Related Macular Degeneration (AMD).

● Pipeline addressing large markets. By initially targeting large markets that have significant medical needs, we believe that we can drive adoption of new products and improve our competitive position. For example, we believe that our immunomodulator lead asset, EOM613, a peptide nucleic-acid solution with dual mechanism of action (both anti-inflammatory and pro-inflammatory) will be a cost-effective therapeutic approach to aid millions in not only managing the symptoms of cancer cachexia and rheumatoid arthritis but in COVID-19 and other viral diseases. Moreover, the ease of administering EOM147 via an at-home eyedrop solution as opposed to a monthly intraocular injection at a certified ophthalmologist, will ease the burden of millions of people suffering from Aged Related Macular degeneration, diabetic retinopathy and other debilitating retinal diseases. These diseases can have significant effects on patients’ quality of life and save employers from significant workplace-related costs and limitations.

● Experienced leadership. Our leadership team possesses core capabilities in infectious diseases, cancer cachexia, retinal diseases, drug development, chemistry, manufacturing and controls, and finance. In addition to our internal capabilities, we have also established a network of key opinion leaders, contract research organizations, contract manufacturing organizations and consultants. As a result, we believe we are well positioned to efficiently develop novel treatments for inflammatory and immune-related diseases. Nevertheless, we only recently commenced operations, never received approval for any IND, NDA or comparable foreign regulatory filing and may never receive any such approval. Moreover, we may not be successful in obtaining market approval for any of our drug candidates.

Our Business Strategy

Our business strategy is to develop and commercialize innovative drug products that address medical needs for large markets with limited competition.

Our mission is to Rescue, Repair, and Restore^TM health in patients suffering from debilitating and life threatening diseases. EOM Pharmaceuticals was founded with a specific vision to pursue innovative approaches to address some of today’s medical needs. We believe our investigational products have mechanisms of action that may transform the therapeutic paradigm of debilitating diseases such as the hyperimmune effects in patients with severe COVID-19, cancer cachexia, rheumatoid arthritis, and inflammatory conditions of the retina characterized by a breakdown of the blood-retinal barrier.

Key elements of our strategy include:

● Advance EOM613 clinical development in Brazil for the hyperimmune response in severe COVID-19 patients

● Advance EOM613 clinical development in the U.S. for cancer cachexia

● Conduct an exploratory study in the U.S. for EOM613 in rheumatoid arthritis

● Advance EOM147 clinical development for diabetic retinopathy in initial clinical trials ex-USA, and retinal vein occlusions in US clinical trials

● Build out a commercialization organization and if approved, commercialize EOM613 in the United States

● Pursue market opportunities for EOM613 outside the United States

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●	Develop EOM613 as a cost-effective therapy for Cancer Cachexia and Rheumatoid Arthritis. We are applying our expertise in immune modulation and inflammation therapies, and clinical trial management, to develop EOM613 as a potential cost-effective treatment for Cancer Cachexia and Rheumatoid Arthritis. Based on multiple prior clinical trials, such as exploratory trials in cancer cachexia in the United States and Canada concluded in 2013, and a trial in rheumatoid arthritis conducted in Argentina a decade prior, we believe EOM613 presents a strong development program. Based on these positive past clinical trial results and the results of additional animal studies planned for 2022 we are evaluating opportunities to apply, as applicable, for expedited regulatory review programs, which could potentially lead to faster clinical development and commercialization timelines. In general, any IND application is subject to a lengthy regulatory review. Although under limited circumstances, drug candidates may be approved for the FDA’s fast-track approval program, we can provide no assurance that our drug candidates will be approved for the fast-track approval program, or that if approved, we will successfully complete the review process of EOM613 on an accelerated basis, if at all.
	We are in the process of initiating all the necessary IND-enabling preclinical safety pharmacology studies and toxicology studies that would enable us to proceed into new Phase II clinical trials in cancer cachexia and/or rheumatoid arthritis. We are conducting these studies with CROs. We are also pursuing studies using established animal models of cancer cachexia and rheumatoid arthritis that simulate human disease, whose results are typically evaluated by the FDA as well. We expect that these animal studies will also enable us to elucidate the pharmacological mechanisms of action of EOM613 and correlate them with previously established laboratory cell culture studies. We expect these studies to be concluded by the third quarter of 2022, at which time we expect to have selected at least one of these disease states to conduct an initial Phase I/II clinical trial, based on a thorough evaluation of the animal data. At that point we intend to seek a pre-IND meeting with the FDA in preparation of filing an IND application, with the intent of commencing a trial in the chosen clinical indication in the first quarter of 2023.
●	Establish EOM147 as the leading treatment for chronic and debilitating retinal diseases. Our goal is to obtain regulatory approval for EOM147 and commercialize EOM147 for use in the treatment of chronic retinal disease including Age Related Macular degeneration, diabetic retinopathy among other angiogenic retinal disorders. Based on previous early-stage clinical trial results in which patients treated with EOM147 experienced meaningful improvements of their symptoms with minimal side effects, we plan on conducting additional research and development to improve our drug therapy and initiate a confirmatory Phase 2b clinical study evaluating EOM147 in chronic retinal disease patients starting in the first quarter of 2023. Because our drug delivery method is via non-invasive eyedrops rather than an intraocular injection directly into the eye, we believe our novel delivery application along with positive past trials results will improve vision outcomes beyond that achieved with current standard of care. We are developing a new synthetic procedure for the manufacture of the Squalamine Lactate active pharmaceutical ingredient of EOM147 eye drops and conducting the development of novel formulations with potentially enhanced retinal uptake, based on our proprietary technology. We plan on establishing a commercial cGMP manufacturing process for the novel formulations and evaluating the new eye drop formulations in rabbit eye studies at a preclinical testing CRO site. We intend to conduct the FDA-required rabbit eye toxicology studies as well as studies measuring the drug uptake into the rabbit eyes’ retinas from the front of the eye administration using specialized techniques of measuring the drug uptake and concentration in the ocular tissues These studies are expected to be completed by the second or third quarter of 2023. We currently envision initial ex-US clinical trials in diabetic retinopathy and in wet-AMD in India and Mexico and confirmatory investigator-sponsored trials in the US for treatment of retinal vein occlusions and macular edema secondary to proliferative diabetic retinopathy.
●	Maximize our current portfolio opportunity by expanding use across multiple indications. We aim to expand our current drug portfolio to treat multiple diseases. Our assets are designed to modulate pathways that are implicated across a number of immune and inflammatory conditions. We plan on developing future proof-of-concept clinical studies of EOM613 as a potential treatment for patients with a number of autoimmune gastrointestinal disorders as well as disorders affecting the central nervous system.
●	In-license promising product candidates. We are applying our cost-effective development approach to advance and expand our pipeline. Although we currently rely on a limited number of candidates, our long- term objective is to maintain a well-balanced portfolio with product candidates across various stages of development. In general, we seek to identify product candidates and technology that represent a novel therapeutic approach, are supported by compelling science, target a medical need, and provide a meaningful commercial opportunity. We do not currently intend to invest significant capital in basic research, which can be expensive and time-consuming.
●	Maximize our current portfolio opportunity by expanding use across multiple indications. We aim to expand our current drug portfolio to treat multiple diseases. While we believe our assets are designed to modulate pathways that are implicated across a number of immune and inflammatory conditions, we currently only have a limited number of product candidates. We plan on developing future proof-of-concept clinical studies of EOM613 as a potential treatment for patients with a number of autoimmune gastrointestinal disorders as well as disorders affecting the central nervous system.

Recent Developments

We filed our original Certificate of Incorporation with the Secretary of State of Delaware on March 20, 1987, under the name Redwing Capital Corp. On June 16, 1989, we changed our name to Patco Industries, Ltd. and conducted an unrelated business under that name until 1994. On January 30, 2006, we amended our Certificate of Incorporation to change our name to Optical Molecular Imaging, Inc. On November 2, 2006, we amended our Certificate of Incorporation to change our name to ImmunoCellular Therapeutics, Ltd.

On December 1, 2021, we completed the acquisition of EOM Pharmaceuticals, Inc., a Delaware corporation. The transaction was accounted for as a reverse merger, with EOM Pharmaceuticals, Inc. deemed to be the accounting acquirer and ImmunoCellular Therapeutics Ltd. deemed to be the legal acquirer. As such, the consolidated financial statements herein reflect the historical activity of EOM Pharmaceuticals, Inc. since its inception on March 27, 2020.

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On ______________, 2022, we amended our Certificate of Incorporation to change our name to EOM Pharmaceuticals Holdings, Inc. to reflect the acquisition of EOM Pharmaceuticals, Inc. and the new direction of our business.

Our Corporate Information

Our principal executive offices are located at 136 Summit Avenue, Suite 100 Montvale, NJ 07645, and our telephone number at that address is (201) 351-0605.

Our Team

We have assembled an experienced management team and board of directors (the “Board of Directors”) to pursue innovative approaches to solving the problems of urgent and medical needs. EOM is led by an accomplished team with a deep legacy in multiple therapeutic areas and drug development.

Our Founder, Chairman and Chief Operating Officer, Eli Goldberger, is a successful entrepreneur, focusing on advancing innovations in pharmaceuticals, women’s health and energy. Our Chief Executive Officer, Irach Taraporewala, PhD., is a highly seasoned pharmaceutical company executive with specific experience in leadership of start-up pharmaceutical companies and over 25 years of experience in drug development and regulatory strategy. Our Chief Scientific Officer and Medical Director, Shalom Hirschman, M.D., has had a long and illustrious career as an academic physician, research scientist, educator, biotechnology entrepreneur and consultant. A graduate of the Albert Einstein College of Medicine, Dr. Hirschman served as intern and resident in medicine at The Massachusetts General Hospital of the Harvard Medical School followed by years of conducting research in molecular biology at the National Institutes of Health in Bethesda, MD. He joined the faculty of The Mount Sinai School of Medicine where he was Director of the Division of Infectious Diseases and Professor of Medicine. Our Chief Financial Officer, Wayne Danson, a former partner in multiple Big 4 public accounting firms and accomplished C level executive, has over 35 years of experience in international and corporate taxation, financial advisory services including investment banking, and mergers and acquisitions, business strategy, and entrepreneurship.

Nevertheless, the Company has never submitted an IND, NDA or comparable foreign regulatory filing and may not be successful in obtaining market approval for any product candidate.

Summary of Risks Associated with Our Business

Our business and an investment in our company is subject to numerous risks and uncertainties, including those highlighted in the section titled “Risk Factors” immediately following this prospectus summary. Some of these risks include:

● We are a pre-revenue company with a limited operating history. Since inception, we have incurred significant operating losses. At March 31, 2022, we had an accumulated deficit of approximately $7.4 million;

● We will need substantial additional funding to finance our operations through regulatory approval of one or more of our product candidates. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts;

● To date, we have been entirely funded by the Goldberger family. Eli Goldberger is our co-founder, Chairman, Chief Operating Officer and largest stockholder. There can be no assurance that the Goldberger family will continue to fund our operations on favorable terms, if at all. We currently expect to use $687,500 of the net proceeds from this offering to repay approximately 25% of the principal on the outstanding promissory note issued to a member of the Goldberger family.

● We are entirely dependent on the success of our drug product candidates. If we are unable to obtain regulatory approval or commercialize one or more of these experimental treatments, or experience significant delays in doing so, our business will be materially harmed;

● The FDA might not allow us to pursue the Section 505(b)(2) pathway for EOM613 and EOM147 and, if so, we may be unable to meet our anticipated development and commercialization timelines and may be unable to generate the additional required data at a reasonable cost;

● We may not be able to successfully develop or commercialize our existing drug product candidates or develop new drug product candidates on a timely or cost-effective basis;

● Our business may be negatively affected by the ongoing COVID-19 pandemic;

● We depend on a limited number of drug product candidates and our business could be materially adversely affected if one or more of our key drug product candidates do not perform as well as expected and do not receive regulatory approval;

● We may be in the future, a party to legal proceedings that could result in adverse outcomes;

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● Our competitors and other third parties may allege that we are infringing their intellectual property, forcing us to expend substantial resources in resulting litigation, and any unfavorable outcome of such litigation could have a material adverse effect on our business;

● We may experience failures of or delays in clinical trials which could jeopardize or delay our ability to obtain regulatory approval and commence product commercialization;

● We face intense competition from both brand and generic companies who have significant financial resources which could limit our growth and adversely affect our financial results;

● Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation.

● We will be competing against large existing well-funded pharmaceutical companies with existing and proposed competing products.

● We are subject to extensive governmental regulation and we face significant uncertainties and potentially significant costs associated with our efforts to comply with applicable regulations;

● We may not be able to develop or maintain our sales capabilities or effectively market or sell our products;

● Manufacturing or quality control problems may damage our reputation, require costly remedial activities or otherwise negatively impact our business;

● Our profitability may depend on coverage and reimbursement by third-party payors including government agencies, and healthcare reform and other future legislation may lead to reductions in coverage or reimbursement levels;

● We face risks related to health epidemics and outbreaks, including the COVID-19 pandemic, which could significantly disrupt our preclinical studies and clinical trials, research activities and therefore our receipt of necessary regulatory approvals could be delayed or prevented;

● We do not currently own any patents and our technology is largely based on expired patents. If we are unable to obtain and maintain patent protection for our product candidates we may develop, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products we may develop may be adversely affected;

● We currently, and may in the future need to, license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms;

● We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our products and product candidates;

● If we fail to comply with our obligations under any of our third-party agreements, we could lose license rights that are necessary to develop our product candidates; 

● Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel; and

● After this offering, our directors, executive officers and certain stockholders (one of which is an affiliate of our Founder and Chief Operating Officer) will continue to own a majority of our common stock and, if they choose to act together, will be able to exert absolute control over matters subject to stockholder approval.

8

Summary of the Offering

Shares being Offered:
Common Stock Outstanding Before this Offering	113,270,751
Common Stock Outstanding After this Offering
Use of Proceeds	We expect to receive net proceeds, after deducting underwriting discounts and commissions and estimated expenses payable by us, of approximately $_____ million (or approximately $______ million if the underwriters exercise their option to purchase additional shares in full). We intend to use substantially all of the net proceeds from this offering to continue to fund research and development of our EOM613 and EOM147 drug candidates, conduct clinical trials, repay a portion of our outstanding Convertible Promissory Note issued to a principal stockholder, and for working capital and other general corporate purposes. See “Use of Proceeds”
Underwriters’ over-allotment option	We have granted the underwriters a 45-day option from the date of this prospectus to purchase up to an additional _________ shares (15% of the total number of shares to be offered by us in the offering).
Trading Market for our Common Stock	Our Common Stock is currently traded on the Pink Sheets of the OTC Market under the symbol “IMUC”. We have applied to have our Common Stock listed for trading on the Nasdaq Capital Market. There can be no assurance that our Common Stock will be approved for trading on the Nasdaq.
Risk Factors	See “Risk Factors” beginning on page 11 of this prospectus and the other information included in this prospectus for a discussion of factors you should carefully consider before investing in our securities.

The number of shares of our common stock to be outstanding after this offering is based on 113,270,751 shares of our common stock outstanding as of the date hereof, and does not include:

● 4,418,998 shares of common stock issuable upon exercise of outstanding warrants; and

● 4,585,665 shares of common stock issuable upon the conversion, at the option of the Holder of our Convertible Promissory Note, at an exercise price of $0.60 per share.

Except as otherwise indicated herein, all information in this prospectus assumes:

● no exercise by the underwriters of their option to purchase an additional _____ shares of common stock, to cover over-allotments, if any; and

● a 1-for-___ reverse stock split of our common stock that was implemented on ______________, 2022, pursuant to which (i) every _____ shares of outstanding common stock were decreased to one share of common stock, (ii) the number of shares of common stock for which each outstanding warrant or option to purchase common stock is exercisable was proportionally decreased on 1-for-_____ basis, and (iii) the exercise price of each outstanding warrant or option to purchase common stock was proportionately increased on a 1-for-______ basis, (the “Reverse Stock Split”).

9

SUMMARY FINANCIAL DATA

You should read the following summary financial data together with our financial statements and the related notes appearing at the end of this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus. We have derived the statement of operations data from our audited consolidated financial statements for the year ended December 31, 2021, and for the period from March 27, 2020 (Inception) through December 31, 2020, and from our unaudited interim condensed consolidated financial statements for the periods ended March 31, 2022, and 2021. We have derived the balance sheet data from our unaudited interim condensed consolidated financial statements for the period ended March 31, 2022. Our historical results are not necessarily indicative of results that should be expected in any future period.

On December 1, 2021, we completed the acquisition of EOM Pharmaceuticals, Inc. The transaction was accounted for as a reverse merger, with EOM Pharmaceuticals, Inc. deemed to be the accounting acquirer and ImmunoCellular Therapeutics Ltd. deemed to be the legal acquirer. Accordingly, these summary financial data reflect the historical activity of EOM Pharmaceuticals, Inc.

				From March 27, 2020			Three Months Ended
				(Inception) to			March 31,
	December 31, 2021			December 31, 2020			2022			2021
Statement of Operations Data:
Research and Development	$	1,301,437		$	696,718		$	383,247		$	506,977
Marketing and Advertising		554,025			474,000			39,565			356,600
General and administrative		758,000			282,274			372,788			143,351
Total Operating Expenses		2,613,462			1,452,992			795,600			1,006,928
Loss from Operations		(2,613,462	)		(1,452,992	)		(795,600	)		(1,006,928	)
Other income (expense)		-						-			-
Interest income (expense) (net)		8,462			-			10,292			-
Loss on debt extinguishment		2,527,078			-			-			-
Total Other income (expense)		(2,535,540	)		-			10,292			-
Net loss	$	(5,149,002	)	$	(1,452,992	)	$	(785,308	)	$	(1,006,928	)
(Loss) per share - basic and diluted:		(0.11	)		(0.03	)		(0.01	)		(0.02	)
Weighted Average common shares outstanding-basic and diluted(1):		47,535,953			45,075,538			113,270,751			45,075,538

(1) See Note 1 to our audited consolidated financial statements as of December 31, 2021 and our unaudited interim condensed consolidated financial statement for the three-month periods ended March 31, 2022 and 2021, appearing at the end of this prospectus for further details on the calculation of basic and diluted net loss per common share.

	March, 31, 2022
	Actual			As Adjusted(1)
Balance Sheet Data:
Cash	$	933,148		$
Working capital	$	374,531		$
Total assets	$	1,102,610		$
Accounts payable and accrued expenses	$	728,079		$
Accumulated deficit	$	(7,387,302	)	$
Stockholders’ equity (deficit)	$	(2,401,133	)	$

(1) As adjusted giving effect to our issuance and sale of ___________ shares of our common stock in this offering at the assumed offering price of $__________per share, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

10

RISK FACTORS

Any investment in our Common Stock involves a high degree of risk. Investors should carefully consider the risks described below and all of the information contained in this prospectus before deciding whether to purchase our Common Stock. Our business, financial condition and results of operations could be materially adversely affected by these risks if any of them actually occur. This prospectus also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks we face as described below and elsewhere in this prospectus.

Risks Related to Our Financial Position and Need for Additional Capital

We are an early-clinical stage pharmaceutical company with a limited operating history.

We were established and began operations in 2020. Our operations to date have been limited to financing and staffing our company, and conducting clinical trials outside the United States of our EOM613 formulation for complications resulting from COVID-19. We have not yet demonstrated the ability to successfully complete a large-scale, pivotal clinical trial, obtain marketing approval, manufacture a commercial scale product, arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.

Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early stages of development, especially early clinical stage pharmaceutical companies such as ours. Potential investors should carefully consider the risks and uncertainties that a company with a limited operating history will face. In particular, potential investors should consider that we cannot assure you that we will be able to, among other things:

● successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound;

● successfully manufacture our clinical product candidates and establish a commercial supply;

● successfully complete the clinical trials necessary to obtain regulatory approval for the marketing of our product candidates;

● secure market exclusivity and/or adequate intellectual property protection for our product candidates;

● attract and retain an experienced management and advisory team;

● secure acceptance of our product candidates in the medical community and with third-party payors and consumers;

● raise sufficient funds in the capital markets or otherwise to effectuate our business plan; and

● utilize the funds that we do have and/or raise in this offering or in the future to efficiently execute our business strategy.

If we cannot successfully execute any one of the foregoing, our business may fail and your investment will be adversely affected.

11

We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability.

We are an early clinical stage biopharmaceutical company with a limited operating history and have incurred losses since our formation. We incurred a net loss of approximately $800,000 for the three-months ended March 31, 2022 and $5.1 million for the year ended December 31, 2021. As of March 31, 2022, we had an accumulated loss of approximately $7.4 million. We have not commercialized any product candidates and have never generated revenue from the commercialization of any product. To date, we have devoted most of our financial resources to research and development, including our clinical work, and to intellectual property.

We expect to incur significant additional operating losses for the next several years, at least, as we advance EOM613 and EOM147 through clinical development, complete clinical trials, seek regulatory approval and commercialize our formulas, if approved. The costs of advancing product candidates into each clinical phase tend to increase substantially over the duration of the clinical development process. Therefore, the total costs to advance any of our product candidates to marketing approval in even a single jurisdiction will be substantial. Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of any products or achieve or maintain profitability. Our expenses will also increase substantially if and as we:

● are required by the FDA, to complete the various animal toxicity and dosing studies

● are required by the FDA, to complete the various phases in human trials;

● establish a sales, marketing and distribution infrastructure to commercialize our drugs, if approved, and for any other product candidates for which we may obtain marketing approval;

● maintain, expand and protect our intellectual property portfolio;

● hire additional clinical, scientific and commercial personnel;

● add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts, as well as to support our transition to a public reporting company; and

● acquire or in-license or invent other product candidates or technologies.

Furthermore, our ability to successfully develop, commercialize and license any product candidates and generate product revenue is subject to substantial additional risks and uncertainties, as described under “Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval” and “Risks Related to Commercialization.” As a result, we expect to continue to incur net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital. The amount of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If we are unable to develop and commercialize one or more product candidates, either alone or through collaborations, or if revenues from any product that receives marketing approval are insufficient, we will not achieve profitability. Even if we do achieve profitability, we may not be able to sustain profitability or meet outside expectations for our profitability. If we are unable to achieve or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially and adversely affected.

Even if this offering is successful, we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our drugs.

Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts to advance the clinical development of and launch and commercialize our product candidates if we receive regulatory approval. Following this offering, we will require additional capital for further research and development and commencement of clinical trials of EOM613 and EOM147 and may also need to raise additional funds sooner to pursue a more accelerated development of our formulas. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs, clinical trials or any future commercialization efforts.

12

We believe that the net proceeds from this offering will enable us to fund our operating expense requirements through December 2023 following the closing of this offering. We have based this estimate on assumptions that may prove to be wrong, and we could deploy our available capital resources sooner than we currently expect. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to the:

● initiation, progress, timing, costs and results of preclinical studies and clinical trials, including patient enrollment in such trials, for EOM613 and EOM147 or any other future product candidates;

● various clinical development plans we establish for EOM613 and EOM147 and any other future product candidates;

● number and characteristics of product candidates that we discover or in-license and develop;

● outcome, timing and cost of regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we planned for;

● costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing other intellectual property rights;

● effects of competing technological and market developments;

● costs and timing of the implementation of commercial-scale manufacturing activities;

● costs and timing of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval; and

● cost associated with being a public company.

If we are unable to expand our operations or otherwise capitalize on our business opportunities due to a lack of capital, our ability to become profitable will be compromised.

Raising additional capital may cause dilution to our stockholders, including purchasers of common stock in this offering, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, as we can generate substantial revenue, we may finance our cash needs through a combination of equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources. We do not currently have any committed external source of funds. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, intellectual property, future revenue streams or product candidates or grant licenses on terms that may not be, in hindsight, favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate product candidate development or future commercialization efforts.

13

There is substantial doubt about our ability to continue as a going concern.

Our independent public accounting firm in its report included herein included an explanatory paragraph expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available. Going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business over a reasonable length of time. Our ability to continue as a going concern ultimately is dependent on our ability to generate a profit which is dependent upon our ability to obtain additional equity or debt financing, attain further operating efficiencies and, ultimately, to achieve profitable operations. As a result, our financial statements do not reflect any adjustment which would result from our failure to continue to operate as a going concern. Any such adjustment, if necessary, would materially affect the value of our assets.

Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval

Clinical trials are expensive, time-consuming and difficult to design and implement, and involve an uncertain outcome.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Because the results of early clinical trials are not necessarily predictive of future results, EOM613 and EOM147 may not have favorable results in future preclinical and clinical studies or receive regulatory approval. We may experience delays in initiating and completing any clinical trials that we intend to conduct, and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, or at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

● the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies;

● obtaining regulatory approval to commence a trial;

● reaching an agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

● obtaining Institutional Review Board (“IRB”), approval at each site, or Independent Ethics Committee (“IEC”), approval at sites outside the United States;

● recruiting suitable patients to participate in a trial in a timely manner and in sufficient numbers;

● having patients complete a trial or return for post-treatment follow-up;

● imposition of a clinical hold by regulatory authorities, including as a result of unforeseen safety issues or side effects or failure of trial sites to adhere to regulatory requirements or follow trial protocols;

● clinical sites deviating from trial protocol or dropping out of a trial;

● addressing patient safety concerns that arise during the course of a trial;

● adding a sufficient number of clinical trial sites; or

● manufacturing sufficient quantities of product candidate for use in clinical trials.

We could also encounter delays if a clinical trial is suspended or terminated by us, the IRBs or IECs of the institutions in which such trials are being conducted, the Data Safety Monitoring Board (“DSMB”) for such trial or the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Furthermore, we rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials, including clinical trial data collection, and, while we have agreements governing their committed activities, we have limited influence over their actual performance, as described in “Risks Related to Our Dependence on Third Parties”.

14

The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for EOM613 and/or EOM147 or any other product candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain regulatory approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate and it is possible that we will never obtain regulatory approval for EOM613 and EOM147 or any other product candidate. We are not permitted to market any of our product candidates in the United States until we receive regulatory approval of an New Drug Application (“NDA”) from the FDA. Our product candidates could fail to receive regulatory approval for many reasons, including the following:

● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

● serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates, or other products containing the active ingredient in our product candidates;

● negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

● the data collected from clinical trials of our product candidates may not be acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials;

● the FDA or comparable foreign authorities may disagree regarding the formulation, labeling and/or the specifications of our product candidates;

● the FDA or comparable foreign regulatory authorities may fail to approve or find deficiencies with the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

● the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Prior to obtaining approval to commercialize a product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or foreign regulatory agencies, that such product candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if we believe the preclinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities.

15

The FDA or any foreign regulatory bodies can delay, limit or deny approval of our product candidates or require us to conduct additional preclinical or clinical testing or abandon a program for many reasons, including:

● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

● the FDA or comparable foreign regulatory authorities may disagree with our safety interpretation of our product candidate;

● the FDA or comparable foreign regulatory authorities may disagree with our efficacy interpretation of our product candidate; and

● the FDA or comparable foreign regulatory authorities may regard our CMC package as inadequate.

Of the large number of drugs in development, only a small percentage successfully complete the regulatory approval processes and are commercialized. This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market EOM613 and/or EOM147, or another product candidate, which would significantly harm our business, results of operations and prospects.

In addition, the FDA or the applicable foreign regulatory agency also may approve a product candidate for a more limited indication or patient population than we originally requested, and the FDA or applicable foreign regulatory agency may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

If we are unable to file for approval of EOM613 and EOM147 under Section 505(b)(2) of the FDCA or if we are required to generate additional data related to safety and efficacy in order to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development and commercialization timelines.

Our current plans for filing NDAs for EOM613 and EOM147 include efforts to minimize the data we will be required to generate in order to obtain marketing approval and therefore reduce the development time. We intend to file Section 505(b)(2) NDAs for EOM613 and EOM147 that might, if accepted by the FDA, save time and expense in the development and testing of these indications.

The timeline for filing and review of our NDAs for EOM613 and EOM147 is based on our plan to submit the NDAs under Section 505(b)(2) of the FDA, which would enable us to rely in part on data in the public domain or elsewhere. Previous trials in cancer cachexia were carried out by OHR Pharmaceuticals on EOM613 (known previously as OHR/AVR118), the data for which will form the basis of our 505(b)(2) filings, together with new preclinical data we are planning on generating to augment the forthcoming FDA submissions to be compliant with current FDA guidance and requirements for NDAs. For our NDA submission for drug candidate EOM147 we will be relying in part on the clinical data of the drug product OHR-102 0.2% squalamine lactate ophthalmic formulation in previously conducted clinical trials in wet-AMD, retinal vein occlusions and proliferative diabetic retinopathy that were acquired by the previous sponsor, OHR Pharmaceutical, Inc. Our eye drop product EOM147 represents a novel, different, enhanced formulation of the OHR-102 ophthalmic solution formulation. We have not yet filed an NDA under Section 505(b)(2) for any of our product candidates. Depending on the data that may be required by the FDA for approval, some of the data may be related to products already approved by the FDA. Neither of our pipeline products EOM613 or EOM147 are currently approved drug products in any jurisdiction. If the data relied upon is related to products already approved by the FDA and covered by third-party patents, we would be required to certify that we do not infringe the listed patents or that such patents are invalid or unenforceable. As a result of the certification, the third-party would have 45 days from notification of our certification to initiate an action against us. In the event that an action is brought in response to such a certification, the approval of our NDA could be subject to a stay of up to 30 months or more while we defend against such a suit. Approval of our product candidates under Section 505(b)(2) may therefore be delayed until patent exclusivity expires or until we successfully challenge the applicability of those patents to our product candidates. Alternatively, we may elect to generate sufficient additional clinical data so that we no longer rely on data which triggers a potential stay of the approval of our product candidates. Even if no exclusivity periods apply to our applications under Section 505(b)(2), the FDA has broad discretion to require us to generate additional data on the safety and efficacy of our product candidates to supplement third-party data on which we may be permitted to rely. In either event, we could be required, before obtaining marketing approval for any of our product candidates, to conduct substantial new research and development activities beyond those we currently plan to engage in order to obtain approval of our product candidates. Such additional new research and development activities would be costly and time consuming.

We intend to pursue the FDA’s 505(b)(2) pathway for both of our pipeline products, EOM613 and EOM147. While both the statutory 505(b)(1) and 505 (b) (2) pathways require a full accounting of safety and efficacy of candidate drug products to seek FDA approval, the latter pathway provides added flexibility for how this requirement is met. The FDA allows this flexibility to avoid unnecessary additional testing by relying on prior available data, where the application contains some information coming from studies not conducted directly by and for the applicant, and for which the applicant has not obtained a right of reference. Given the prior preclinical and clinical information available for EOM613 and a progenitor formulation of the EOM 147 drug product in prior ex-U.S. clinical studies, as to their safety and effectiveness, we believe the 505(b)(2) pathway is appropriate for both drug products in our pipeline. We have not had a pre-IND meeting as yet with the FDA regarding our ability to use this pathway for either or both of our products. We do intend to use and include prior clinical data, including data derived for our clinical drug candidates in clinical trials carried out in the USA and abroad by previous sponsors, in support of our NDA, in addition to our own planned new clinical trials.

We may not be able to realize a shortened development timeline for EOM613 and EOM147, and the FDA may not approve either of our NDAs based on their review of the submitted data. Moreover, if products containing the reference drug are withdrawn from the market by the FDA for any safety reason, we may not be able to reference such products to support a 505(b)(2) NDA for our product candidates, and we may need to fulfill the more extensive requirements of Section 505(b)(1). If we are required to generate additional data to support approval, we may be unable to meet our anticipated development and commercialization timelines, may be unable to generate the additional data at a reasonable cost, or at all, and may be unable to obtain marketing approval of our lead product candidate.

16

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials. Patient enrollment and retention in clinical trials depends on many factors, including:

● the patient eligibility criteria defined in the protocol;

● the size of the patient population required for analysis of the trial’s primary endpoints;

● the nature of the trial protocol;

● the existing body of safety and efficacy data with respect to the product candidate;

● the proximity of patients to clinical sites;

● our ability to recruit clinical trial investigators with the appropriate competencies and experience;

● clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;

● competing clinical trials being conducted by other companies or institutions;

● our ability to maintain patient consents; and

● the risk that patients enrolled in clinical trials will drop out of the trials before completion.

We face risks related to health epidemics and outbreaks, including the COVID-19 pandemic, which could significantly disrupt our preclinical studies and clinical trials, and therefore our receipt of necessary regulatory approvals could be delayed or prevented.

We face risks related to health epidemics or outbreaks of communicable diseases. For example, the recent outbreak around the world, including in the United States, the European Union (the “EU”) members, China and many other countries, of the highly transmissible and pathogenic COVID-19 and its Omicron variant. The outbreak of such communicable diseases could result in a widespread health crisis that could adversely affect general commercial activity and the economies and financial markets of many countries, which in the case of COVID-19 has occurred. In addition, the COVID-19 pandemic is having a severe effect on the clinical trials of many drug candidates. Some trials have been merely delayed, while others have been cancelled. The extent to which the COVID-19 pandemic may impact our preclinical and clinical trial operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration and geographic reach of the outbreak, the severity of COVID-19, and the effectiveness of actions to contain and treat COVID-19. The continued spread of COVID-19 globally could adversely impact our clinical trial operations, including our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs in their geography. Disruptions or restrictions on our ability to travel to monitor data from our clinical trials, or to conduct clinical trials, or the ability of patients enrolled in our studies to travel, or the ability of staff at study sites to travel, as well as temporary closures of our facilities or the facilities of our clinical trial partners and their contract manufacturers, would negatively impact our clinical trial activities. In addition, we rely on independent clinical investigators, CROs and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies and clinical trials, including the collection of data from our clinical trials, and the outbreak may affect their ability to devote sufficient time and resources to our programs or to travel to sites to perform work for us. Similarly, our preclinical trials could be delayed and/or disrupted by the COVID-19 pandemic. As a result, the expected timeline for data readouts of our preclinical studies and clinical trials and certain regulatory filings may be negatively impacted, which would adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses and have a material adverse effect on our financial results.

17

Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials.

The results of preclinical studies, early clinical trials or analyses of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. In addition, conclusions based on promising data from analyses of clinical results may be shown to be incorrect when implemented in prospective clinical trials. Even if our clinical trials for EOM613 and/or EOM147 are completed as planned, we cannot be certain that their results will support the safety and efficacy sufficient to obtain regulatory approval.

Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim “top-line” or preliminary data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

Our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.

Serious adverse events or undesirable side effects caused by our products could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Any clinical trials for our drug product candidates to date may fail to demonstrate acceptable levels of safety and efficacy which could prevent or significantly delay their regulatory approval or result in a more restrictive label by the FDA or other comparable foreign authorities.

If unacceptable side effects arise in the development of our product candidates, we, the FDA or the IRBs at the institutions in which our studies are conducted, or the DSMB, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications. In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Any of these occurrences may harm our business, financial condition and prospects significantly.

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Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:

● regulatory authorities may withdraw approvals of such product;

● regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication;

● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

● we may be required to implement a Risk Evaluation and Mitigation Strategy (“REMS”) or create a medication guide outlining the risks of such side effects for distribution to patients;

● we could be sued and held liable for harm caused to patients;

● the product may become less competitive; and

● our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of a product candidate, if approved, and could significantly harm our business, results of operations and prospects.

The market opportunities for our products, if approved, may be smaller than we anticipate.

We expect to initially seek approval for EOM613 and EOM147. Our estimates of market potential for these formulas have been derived from a variety of sources, including scientific literature, patient foundations, and market research, and may prove to be incorrect. Even if we obtain significant market share for any product candidate, if approved, if the potential target populations are smaller than we anticipate, we may never achieve profitability without obtaining marketing approval for additional indications.

We have never obtained marketing approval for our product candidates and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates.

We have never obtained marketing approval for a product candidate. It is possible that the FDA may refuse to accept for substantive review any NDAs that we submit for our product candidates or may conclude after review of our data that our application is insufficient to obtain marketing approval of our product candidates. In addition, as some of our trials may take place overseas, the FDA may require us to conduct additional studies or trials if it does not accept data from ex-U.S. studies or believes that additional data is necessary to supplement our trial data. If the FDA does not accept or approve our NDAs for our product candidates, it may require that we conduct additional clinical, preclinical, or manufacturing validation studies and submit that data before it will reconsider our applications. Depending on the extent of these or any other FDA-required studies, approval of any NDA that we submit may be delayed or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve our NDAs.

Any delay in obtaining, or an inability to obtain, marketing approvals would prevent us from commercializing our product candidates, generating revenues, and achieving and sustaining profitability. If any of these outcomes occur, we may be forced to abandon our development efforts for our product candidates, which could significantly harm our business.

Even if we obtain FDA approval for our product candidate in the United States, we may never obtain approval for or commercialize our product candidate in any other jurisdiction, which would limit our ability to realize their full market potential.

To market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy. Approval by the FDA in the United States does not ensure approval by regulatory authorities in other countries or jurisdictions. However, the failure to obtain approval in one jurisdiction may negatively impact our ability to obtain approval elsewhere. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country.

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Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approval could result in difficulties and increased costs for us and require additional preclinical studies or clinical trials which could be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. We do not have any product candidates approved for sale in any jurisdiction, including in international markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of any product we develop will be unrealized.

Even if we obtain regulatory approval for our product candidates, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties.

Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, packaging, distribution, adverse event reporting, storage, recordkeeping, export, import, advertising and promotional activities for such product, among other things, will be subject to extensive and ongoing requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, establishment registration and drug listing requirements, continued compliance with current Good Manufacturing Practice (“cGMP”) requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping and Good Clinical Practice (“GCP”) requirements for any clinical trials that we conduct post-approval.

Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product candidate may be marketed or to the conditions of approval, including a requirement to implement a REMS. If any of our product candidates receive marketing approval, the accompanying label may limit the approved indicated use of the product candidate, which could limit sales of the product candidate. The FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a product. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use, and if we market our products for uses beyond their approved indications, we may be subject to enforcement action for off-label marketing. Violations of the FDCA relating to the promotion of prescription drugs may lead to FDA enforcement actions and investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes or failure to comply with regulatory requirements, may yield various results, including:

● restrictions on manufacturing such products;

● restrictions on the labeling or marketing of products;

● restrictions on product distribution or use;

● requirements to conduct post-marketing studies or clinical trials;

● warning letters or untitled letters;

● withdrawal of the products from the market;

● refusal to approve pending applications or supplements to approved applications that we submit;

● recall of products;

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● fines, restitution or disgorgement of profits or revenues;

● suspension or withdrawal of marketing approvals;

● refusal to permit the import or export of our products;

● product seizure; or

● injunctions or the imposition of civil or criminal penalties.

Further, the FDA’s policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

The use of EOM613 or EOM147 or any other product candidates we may develop in clinical trials and the sale of any products for which we obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by patients, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

● impairment of our business reputation and significant negative media attention;

● withdrawal of participants from our clinical trials;

● significant costs to defend the litigation;

● distraction of management’s attention from our primary business;

● substantial monetary awards to patients or other claimants;

● inability to commercialize EOM613, EOM147 or any other product candidate;

● product recalls, withdrawals, or labeling, marketing, or promotional restrictions;

● decreased market demand for any product; and

● loss of revenue.

Risks Related to Commercialization

We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.

The biopharmaceutical and pharmaceutical industries are highly competitive and subject to significant and rapid technological change. Our success is highly dependent on our ability to acquire, develop, and obtain marketing approval for new products on a cost-effective basis and to market them successfully. We face intense competition from a variety of businesses, including large, fully integrated pharmaceutical companies, specialty pharmaceutical companies and biopharmaceutical companies in the United States and other jurisdictions. These organizations may have significantly greater resources than we do and may conduct similar research; seek patent protection; and establish collaborative arrangements for research, development, manufacturing and marketing of products that may compete with us.

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Our competitors may, among other things:

● have significantly greater name recognition, financial, manufacturing, marketing, drug development, technical, and human resources than we do, and future mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors;

● develop and commercialize products that are safer, more effective, less expensive, more convenient, or easier to administer, or have fewer or less severe effects;

● obtain quicker regulatory approval;

● implement more effective approaches to sales and marketing; or

● form more advantageous strategic alliances.

Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel; establishing clinical trial sites and patient registration; and in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are more effective, have fewer or less severe side effects, or are more convenient or are less expensive than EOM613 and EOM147. Our competitors may also obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for EOM613 and EOM147, which could result in our competitors establishing or strengthening their market position before we are able to enter the market.

The successful commercialization of EOM613 or EOM147 and any other product candidate we develop will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels, and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford prescription medications such as EOM613 and EOM147, if approved. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on our ability to successfully commercialize our drug and any other product candidates we develop. Assuming we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the United States or elsewhere will be available for our product candidates or any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

Third-party payors increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs or biologics when an equivalent generic drug, biosimilar, or a less expensive therapy is available. It is possible that a third-party payor may consider our product candidates as substitutable and offer to reimburse patients only for the less expensive product. Even if we show improved efficacy or improved convenience of administration with our product candidates, pricing of existing drugs may limit the amount we will be able to charge for our product candidates. These payors may deny or revoke the reimbursement status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return on our investment in our product candidates. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our product candidates.

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There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models in the United States for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

No uniform policy for coverage and reimbursement for products exists among third-party payors in the United States. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we believe that changes in these rules and regulations are likely.

We may also be subject to extensive governmental price controls and other market regulations outside of the United States, and we believe the increasing emphasis on cost-containment initiatives in other countries have and will continue to put pressure on the pricing and usage of medical products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own prices for medical products but monitor and control company profits.

Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our product candidates may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.

Moreover, increasing efforts by governmental and third-party payors in the United States to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the sale of our product candidates due to the trend toward managed health care, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and biologics and surgical procedures and other treatments, has become intense. As a result, increasingly high barriers are being erected to the entry of new products.

Even if EOM613 and/or EOM147 or any product candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

If EOM613 and/or EOM147 or any product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community. If it does not achieve an adequate level of acceptance, we may not generate significant product revenues or become profitable. The degree of market acceptance of our product candidates, if approved, will depend on a number of factors, including but not limited to:

● the efficacy and potential advantages compared to alternative treatments;

● effectiveness of sales and marketing efforts;

● the cost of treatment in relation to alternative treatments, including any similar generic treatments;

● our ability to offer our products for sale at competitive prices;

● the convenience and ease of administration compared to alternative treatments;

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● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

● the strength of marketing and distribution support;

● the availability of third-party coverage and adequate reimbursement;

● the prevalence and severity of any side effects; and

● any restrictions on the use of our product together with other medications.

Because we expect sales of our product candidates, if approved, to generate substantially all of our revenues for the foreseeable future, the failure of our product candidates to find market acceptance would harm our business and could require us to seek additional financing.

If we are unable to establish sales, marketing, and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing EOM613 and/or EOM147, if approved.

We do not have any infrastructure for the sales, marketing, or distribution of EOM613 or EOM147, and the cost of establishing and maintaining such an organization may exceed the cost-effectiveness of doing so. In order to market and successfully commercialize our drug or any product candidate we develop, if approved, we must build our sales, distribution, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. We expect to build a focused sales, distribution and marketing infrastructure to market EOM613 and/or EOM147, if approved, in the United States and Europe. There are significant expenses and risks involved with establishing our own sales, marketing and distribution capabilities, including our ability to hire, retain and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact the commercialization of that product. For example, if the commercial launch of EOM613 and/or EOM147 for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our product candidates on our own include:

● our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

● the inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe our products; and

● unforeseen costs and expenses associated with creating an independent sales and marketing organization.

We do not anticipate having the resources in the foreseeable future to allocate to the sales and marketing of our product candidates, if approved, in certain markets overseas. Therefore, our future success will depend, in part, on our ability to enter into and maintain collaborative relationships for such capabilities, the collaborator’s strategic interest in a product and such collaborator’s ability to successfully market and sell the product. We intend to pursue collaborative arrangements regarding the sale and marketing of EOM613 and/or EOM147, if approved, for certain markets overseas; however, we cannot assure you that we will be able to establish or maintain such collaborative arrangements, or if able to do so, that they will have effective sales forces. To the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful.

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If we are unable to build our own sales force or negotiate a collaborative relationship for the commercialization of EOM613 and/or EOM147, we may be forced to delay the potential commercialization of the drug or reduce the scope of our sales or marketing activities. If we need to increase our expenditures to fund commercialization activities for EOM613 and/or EOM147 we will need to obtain additional capital, which may not be available to us on acceptable terms, or at all. We may also have to enter into collaborative arrangements for EOM613 and/or EOM147 at an earlier stage than otherwise would be ideal and we may be required to relinquish rights to it or otherwise agree to terms unfavorable to us. Any of these occurrences may have an adverse effect on our business, operating results, and prospects.

If we are unable to establish adequate sales, marketing, and distribution capabilities, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates and may never become profitable. We will be competing with many companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

A variety of risks associated with operating internationally could materially adversely affect our business.

We currently have no international operations, but our business strategy includes potentially expanding internationally if any of our product candidates receive regulatory approval. Doing business internationally involves a number of risks, including but not limited to:

● multiple, conflicting and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

● failure by us to obtain and maintain regulatory approvals for the use of our products in various countries;

● additional potentially relevant third-party patent rights;

● complexities and difficulties in obtaining protection and enforcing our intellectual property;

● difficulties in staffing and managing foreign operations;

● complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

● limits in our ability to penetrate international markets;

● financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;

● natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions;

● certain expenses including, among others, expenses for travel, translation and insurance; and

● regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions, or its anti-bribery provisions.

Any of these factors could significantly harm any future international expansion and operations and, consequently, our results of operations.

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Risks Related to Our Dependence on Third Parties

Our employees and independent contractors, including principal investigators, CROs, consultants, vendors, and any third parties we may engage in connection with development and commercialization, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

Our employees and independent contractors, including principal investigators, CROs, consultants, vendors and any third parties we may engage in connection with development and commercialization of our product candidates, could engage in misconduct, including intentional, reckless or negligent conduct or unauthorized activities that violate: the laws and regulations of the FDA or other similar regulatory requirements of other authorities, including those laws that require the reporting of true, complete and accurate information to such authorities; manufacturing standards; data privacy, security, fraud and abuse and other healthcare laws and regulations; or laws that require the reporting of true, complete and accurate financial information and data. Specifically, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, creation of fraudulent data in preclinical studies or clinical trials or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in Medicare, Medicaid, other U.S. federal healthcare programs or healthcare programs in other jurisdictions, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations.

We currently rely on third-party contract manufacturing organizations (“CMOs”) for the production of clinical supply of EOM613 and EOM147 and intend to rely on CMOs for the production of commercial supply of EOM613 and EOM147, if approved. Our dependence on CMOs may impair or delay the development and commercialization of the drug, which would adversely impact our business and financial position.

We have limited personnel with experience in manufacturing, and we do not own facilities for manufacturing. Instead, we rely on and expect to continue to rely on CMOs for the supply of cGMP grade clinical trial materials and commercial quantities of EOM613 and EOM147 and any product candidates we develop, if approved. Reliance on CMOs may expose us to more risk than if we were to manufacture our product candidates ourselves. We intend to have manufactured a sufficient clinical supply of EOM613 and EOM147 drug substance to enable us to complete our clinical trials, and we have engaged or intend to engage a CMO to provide clinical and commercial supplies of the drug products.

The facilities used to manufacture our product candidates must be inspected by the FDA and comparable foreign authorities. While we provide oversight of manufacturing activities, we do not and will not control the execution of manufacturing activities by, and are or will be essentially dependent on, our CMOs for compliance with cGMP requirements for the manufacture of our product candidates. As a result, we are subject to the risk that our product candidates may have manufacturing defects that we have limited ability to prevent. If a CMO cannot successfully manufacture material that conforms to our specifications and the regulatory requirements, we will not be able to secure or maintain regulatory approval for the use of our product candidates in clinical trials, or for commercial distribution of our product candidates, if approved. In addition, we have limited control over the ability of our CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or comparable foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval or finds deficiencies in the future, we may need to find alternative manufacturing facilities, which would delay our development program and significantly impact our ability to develop, obtain regulatory approval for or commercialize our product candidates, if approved. In addition, any failure to achieve and maintain compliance with these laws, regulations and standards could subject us to the risk that we may have to suspend the manufacture of our product candidates or that obtained approvals could be revoked. Furthermore, CMOs may breach existing agreements they have with us because of factors beyond our control. They may also terminate or refuse to renew their agreement at a time that is costly or otherwise inconvenient for us. If we were unable to find an adequate CMO or another acceptable solution in time, our clinical trials could be delayed, or our commercial activities could be harmed.

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We rely on and will continue to rely on CMOs to purchase from third-party suppliers the raw materials necessary to produce our product candidates. We do not and will not have control over the process or timing of the acquisition of these raw materials by our CMOs. Supplies of raw material could be interrupted from time to time and we cannot be certain that alternative supplies could be obtained within a reasonable timeframe, at an acceptable cost, or at all. In addition, a disruption in the supply of raw materials could delay the commercial launch of our product candidates, if approved, or result in a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates. Growth in the costs and expenses of raw materials may also impair our ability to cost effectively manufacture our product candidates. There are a limited number of suppliers for the raw materials that we may use to manufacture our product candidates and we may need to assess alternative suppliers to prevent a possible disruption of the manufacture of our product candidates.

Finding new CMOs or third-party suppliers involves additional cost and requires our management’s time and focus. In addition, there is typically a transition period when a new CMO commences work. Although we generally have not, and do not intend to, begin a clinical trial unless we believe we have on hand, or will be able to obtain, a sufficient supply of our product candidates to complete the clinical trial, any significant delay in the supply of our product candidates or the raw materials needed to produce our product candidates, could considerably delay conducting our clinical trials and potential regulatory approval of our product candidates.

As part of their manufacture of our product candidates, our CMOs and third-party suppliers are expected to comply with and respect the proprietary rights of others. If a CMO or third-party supplier fails to acquire the proper licenses or otherwise infringes the proprietary rights of others in the course of providing services to us, we may have to find alternative CMOs or third-party suppliers or defend against claims of infringement, either of which would significantly impact our ability to develop, obtain regulatory approval for or commercialize our product candidates, if approved.

We intend to rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business.

We rely, and will continue to rely, on CROs, CRO-contracted vendors and clinical trial sites to ensure the proper and timely conduct of our clinical trials. Our reliance on CROs for clinical development activities limits our control over these activities, but we remain responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards.

We and our CROs will be required to comply with the Good Laboratory Practice (“GLP”) requirements for our preclinical studies and GCP requirements for our clinical trials, which are regulations and guidelines enforced by the FDA and are also required by comparable foreign regulatory authorities. Regulatory authorities enforce GCP requirements through periodic inspections of trial sponsors, principal investigators and clinical trial sites. If we or our CROs fail to comply with GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP requirements. In addition, our clinical trials must be conducted with product produced under cGMP requirements. Accordingly, if our CROs fail to comply with these requirements, we may be required to repeat clinical trials, which would delay the regulatory approval process.

Our CROs are not our employees, and we do not control whether or not they devote sufficient time and resources to our clinical trials. Our CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities, which could harm our competitive position. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which may reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any other reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any product candidate that we develop. As a result, our financial results and the commercial prospects for any product candidate that we develop would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

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If our relationship with any CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves substantial cost and requires management’s time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have an adverse impact on our business, financial condition and prospects.

● the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers; and

● the loss of, or a disruption in our relationship with, any one or more collaborators could harm our business.

If any collaborations do not result in the successful development and commercialization of products or if one of our collaborators terminates its agreement with us, we may not receive any future research and development funding or milestone or royalty payments under such collaborations. If we do not receive the funding we expect under these agreements, our continued development of our product candidates could be delayed, and we may need additional resources to develop additional product candidates. All of the risks relating to product development, regulatory approval and commercialization described in this prospectus also apply to the activities of any collaborators and there can be no assurance that our collaborations will produce positive results or successful products on a timely basis or at all.

In addition, subject to its contractual obligations to us, if one of our collaborators is involved in a business combination or otherwise changes its business priorities, the collaborator might deemphasize or terminate the development or commercialization of our product candidates. If a collaborator terminates its agreement with us, we may find it more difficult to attract new collaborators and the perception of our business and our stock price could be adversely affected.

We may in the future collaborate with additional pharmaceutical and biotechnology companies for development and potential commercialization of therapeutic products. We face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our product candidates or bring them to market or continue to develop our programs, and our business may be materially and adversely affected.

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Risks Related to Healthcare Laws and Other Legal Compliance Matters

Current and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.

In the United States and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively the “ACA”) was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers. Among the provisions of the ACA, those of greatest importance to the pharmaceutical and biotechnology industries include the following:

● an annual, non-deductible fee payable by any entity that manufactures or imports certain branded prescription drugs and biologic agents (other than those designated as orphan drugs), which is apportioned among these entities according to their market share in certain government healthcare programs;

● a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

● new requirements to report certain financial arrangements with physicians and teaching hospitals, including reporting “transfers of value” made or distributed to prescribers and other healthcare providers and reporting investment interests held by physicians and their immediate family members;

● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;

● a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs and biologics that are inhaled, infused, instilled, implanted, or injected;

● extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

● expansion of eligibility criteria for Medicaid programs thereby potentially increasing a manufacturer’s Medicaid rebate liability;

● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

● establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

● expansion of the entities eligible for discounts under the Public Health Service program; and

● a licensure framework for follow on biologic products.

Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, the Budget Control Act of 2011, resulted in aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2027 unless additional action is taken by Congress. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Additionally, the orphan drug tax credit was reduced as part of a broader tax reform. These new laws or any other similar laws introduced in the future may result in additional reductions in Medicare and other health care funding, which could negatively affect our customers and accordingly, our financial operations.

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In addition, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been Congressional inquiries and proposed federal and state legislation designed to bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates or put pressure on our product pricing.

In markets outside of the United States, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action in the United States or any other jurisdiction. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our product candidates, if approved. Such laws include:

● the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving, or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order, or recommendation of, any good, facility, item, or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. The U.S. federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand;

● the U.S. federal false claims and civil monetary penalties laws, including the civil False Claims Act (the “FCA”) which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. A claim includes “any request or demand” for money or property presented to the federal government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims;

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● the U.S. federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose, among other things, specified requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;

● the FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;

● the U.S. federal legislation commonly referred to as the Physician Payments Sunshine Act, enacted as part of the ACA, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the government information related to certain payments and other transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; and

● analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business activities, including our consulting agreements and other relationships with physicians and other healthcare providers, some of whom receive stock or stock options as compensation for their services, could be subject to challenge under one or more of such laws. Ensuring that our current and future internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

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If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, individual imprisonment, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. If any of the physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect our ability to operate our business. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Any clinical trial programs we conduct or research collaborations we enter into in the European Economic Area may subject us to the General Data Protection Regulation.

If we conduct clinical trial programs or enter into research collaborations in the European Economic Area, we may be subject to the General Data Protection regulation (“GDPR”). The GDPR applies extraterritorially and implements stringent operational requirements for processors and controllers of personal data, including, for example, high standards for obtaining consent from individuals to process their personal data, robust disclosures to individuals, a comprehensive individual data rights regime, data export restrictions governing transfers of data from the European Union (the “EU”) to other jurisdictions, short timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to health data, other special categories of personal data and coded data and additional obligations if we contract third-party processors in connection with the processing of personal data. The GDPR provides that EU member states may establish their own laws and regulations limiting the processing of personal data, including genetic, biometric or health data, which could limit our ability to use and share personal data or could cause our costs to increase. If our or our partners’ or service providers’ privacy or data security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data and/or fines of up to 20 million Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.

We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.

Our operations, including our development, testing and manufacturing activities, are subject to numerous environmental, health and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, handling, release and disposal of and the maintenance of a registry for, hazardous materials and biological materials, such as chemical solvents, human cells, carcinogenic compounds, mutagenic compounds and compounds that have a toxic effect on reproduction, laboratory procedures and exposure to blood-borne pathogens. If we fail to comply with such laws and regulations, we could be subject to fines or other sanctions.

As with other companies engaged in activities similar to ours, we face a risk of environmental liability inherent in our current and historical activities, including liability relating to releases of or exposure to hazardous or biological materials. Environmental, health and safety laws and regulations are becoming more stringent. We may be required to incur substantial expenses in connection with future environmental compliance or remediation activities, in which case, the production efforts of our third-party manufacturers or our development efforts may be interrupted or delayed.

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Risks Related to Our Intellectual Property

If we are unable to obtain and maintain patent protection for our technology, products, and product candidates or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

We do not currently own any patents and our technology is largely based on expired patents. If we are unable to obtain and maintain patent protection for our product candidates we may develop, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products we may develop may be adversely affected.

We intend to rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our drug development programs and product candidates. Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to EOM613 and EOM147 and any future products and product candidates. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our development programs and product candidates. The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

If the patent applications we own or license with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for EOM613 and EOM147 or any future product candidates, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize future product candidates. Any such outcome could have a materially adverse effect on our business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our patent rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. However, in certain instances, the laws of the United States are more restrictive than those of foreign countries. For example, a recent series of Supreme Court Cases has narrowed the types of subject matter considered eligible for patenting.

Accordingly, certain diagnostic methods are considered ineligible for patenting in the U.S. because they are directed to a “law of nature”. Further, publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology, products, or product candidates, in whole or in part, or patents being issued which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in patent claims being narrowed, invalidated, held unenforceable, in whole or in part, or reduced patent term. Such a result could limit our ability to stop others from using or commercializing similar or identical technologies and products to ours. Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. While various extensions may be available, the life of a patent is limited. Without patent protection for our current or future products, we may be open to competition from generic versions of such products. Given the amount of time required for the development, testing and regulatory review of new products, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from using or commercializing technologies or products similar or identical to ours.

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We may become subject to third parties’ claims alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to protect or enforce our patents, which could be costly, time consuming, delay or prevent the development and commercialization of our products and product candidates or put our patents and other proprietary rights at risk.

Our commercial success depends, in part, upon our ability to develop, manufacture, market and sell our products and product candidates without alleged or actual infringement, misappropriation or other violation of the patents and proprietary rights of third parties. Litigation relating to infringement or misappropriation of patent and other intellectual property rights in the pharmaceutical and biotechnology industries is common, including patent infringement lawsuits, interferences, oppositions, reexamination, derivation and post-grant proceedings before the U.S. Patent and Trademark Office (“USPTO”), and corresponding foreign patent offices. The various markets in which we plan to operate are subject to frequent and extensive litigation regarding patents and other intellectual property rights. In addition, many companies in intellectual property-dependent industries, including the biotechnology and pharmaceutical industries, have employed intellectual property litigation as a means to gain an advantage over their competitors. Numerous U.S., European and other foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products and product candidates. Some claimants may have substantially greater resources than we do and may be able to sustain the costs of complex intellectual property litigation to a greater degree and for longer periods of time than we could. In addition, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our products and product candidates may be subject to claims of infringement of the intellectual property rights of third parties.

We may be subject to third-party claims including infringement, interference or derivation proceedings, post-grant review and inter parties review before the USPTO or similar adversarial proceedings or litigation in other jurisdictions. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, and the holders of any such patents may be able to block our ability to commercialize the applicable product candidate unless we obtained a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable. These proceedings may also result in our patent claims being invalidated, held unenforceable or narrowed in scope. Similarly, if our patents or patent applications are challenged during interference or derivation proceedings, a court may hold that a third-party is entitled to certain patent ownership rights instead of us. Further, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our compositions, formulations, methods of manufacture, or methods of treatment, prevention or use, the holders of any such patents may be able to block our ability to develop and commercialize the applicable products and product candidates unless we obtained a license or until such patents expire or are finally determined to be invalid or unenforceable. In addition, defending such claims would cause us to incur substantial expenses and, if successful, could cause us to pay substantial damages, if we are found to be infringing a third party’s patent rights. If we are found to have infringed such rights willfully, the damages may be enhanced and may include attorneys’ fees. Further, if a patent infringement suit is brought against us or our third-party service providers, our development, manufacturing or sales activities relating to the product or product candidate that is the subject of the suit may be delayed or terminated. As a result of patent infringement claims, or in order to avoid potential infringement claims, we may choose to seek, or be required to seek, a license from the third party, which may require us to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if a license can be obtained on acceptable terms, the rights may be nonexclusive, which could give our competitors access to the same intellectual property rights. If we are unable to enter into a license on acceptable terms, we could be prevented from commercializing one or more of our products and product candidates, forced to modify such products and product candidates, or to cease some aspect of our business operations, which could harm our business significantly. Modifying our products and product candidates to design around third-party intellectual property rights may result in significant cost or delay to us and could prove to be technically infeasible. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business. In addition, if the breadth or strength of protection provided the patents and patent applications we own, or will own in the future, or in-license is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products and product candidates.

If we were to initiate legal proceedings against a third party to enforce a patent covering one of our products and product candidates, the defendant could counterclaim that our patent is invalid or unenforceable. In patent litigation in the United States and in Europe, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of eligibility, lack of written description, lack of novelty, obviousness or non-enablement. Third parties might allege unenforceability of our patents because someone connected with prosecution of the patent withheld relevant information, or made a misleading statement, during patent prosecution. The outcome of proceedings involving assertions of invalidity and unenforceability during patent litigation is unpredictable. With respect to the validity of patents, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our products and product candidates. Furthermore, our patents and other intellectual property rights also will not protect our technology if competitors design around our protected technology without infringing our patents or other intellectual property rights.

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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors view these announcements in a negative light, the price of common stock could be adversely affected.

Finally, even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors view these announcements in a negative light, the price of our common stock could be adversely affected. Such litigation or proceedings could substantially increase our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have an adverse effect on our ability to compete in the marketplace.

We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our products and product candidates.

We cannot guarantee that any of our or our licensors’ patent searches or analyses, including but not limited to the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States, Europe and elsewhere that is relevant to or necessary for the commercialization of our products and product candidates in any jurisdiction. For example, in the United States, applications filed before November 29, 2000 and certain applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Patent applications in the United States, Europe and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our future products and product candidates, or their manufacture or use may currently be unpublished. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our products and product candidates or the use thereof. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products and product candidates. We may incorrectly determine that our products and product candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States, Europe or elsewhere that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our products and product candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products and product candidates.

From time to time we may identify patents or applications in the same general area as our products and product candidates. We may determine these third-party patents are irrelevant to our business based on various factors including our interpretation of the scope of the patent claims and our interpretation of when those patents expire. If the patents are asserted against us, however, a court may disagree with our determinations. Further, while we may determine that the scope of claims that will issue from a patent application does not present a risk, it is difficult to accurately predict the scope of claims that will issue from a patent application, our determination may be incorrect, and the issuing patent may be asserted against us. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay monetary damages, we may be temporarily or permanently prohibited from commercializing our products and product candidates. We might, if possible, also be forced to redesign our products and product candidates so that we no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

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Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products and product candidates.

As is the case with other biopharmaceutical and pharmaceutical companies, our success is entirely dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical and pharmaceutical industries involve both technological complexity and legal complexity. Therefore, obtaining and enforcing biopharmaceutical and pharmaceutical patents is costly, time-consuming and inherently uncertain. In addition, the America Invents Act, or the AIA, which was passed in September 2011, resulted in significant changes to the U.S. patent system.

An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a “first-to-file” system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that files a patent application in the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours even if we made the invention before it was made by the third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application, but circumstances could prevent us from promptly filing patent applications on our inventions.

Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent before the USPTO. This applies to all of our U.S. patents, even those effectively filed before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.

Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. It is not clear what, if any, impact the AIA will have on the operation of our business. However, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned and in-licensed patent applications and the enforcement or defense of our owned and in-licensed patents.

Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. Similarly, the complexity and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is relatively stringent in the type of amendments that are allowed during prosecution. Complying with these laws and regulations could limit our ability to obtain new patents in the future that may be important for our business.

Obtaining and maintaining protection of patents that we may obtain in the future depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on any issued patent are due to be paid to the USPTO, European Patent Office (“EPO”) and other foreign patent offices over the lifetime of a patent. In addition, the USPTO, EPO and other foreign patent office’s require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent failure to make payment of such fees or to comply with such provisions can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which such noncompliance will result in the abandonment or lapse of the patent or patent application, and the partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents within prescribed time limits. If we or our licensors fail to maintain the patents and patent applications covering our products and product candidates or if we or our licensors otherwise allow our owned or licensed patents or patent applications to be abandoned or lapse, our competitors might be able to enter the market, which would hurt our competitive position and could impair our ability to successfully commercialize our products and product candidates in any indication for which they are approved.

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We enjoy only limited geographical protection with respect to certain patents that we may obtain in the future and we may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents covering our products and product candidates in all countries throughout the world would be prohibitively expensive. Competitors may use our owned and in-licensed technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we and our licensors have patent protection, but enforcement is not as strong as that in the United States or the Europe. These products may compete with our products and product candidates, and patents that we may obtain in the future or in-licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

In addition, we may decide to abandon national and regional patent applications before grant. The grant proceeding of each national or regional patent is an independent proceeding which may lead to situations in which applications might in some jurisdictions be refused by the relevant patent offices, while granted by others. For example, unlike other countries, China has a heightened requirement for patentability, and specifically requires a detailed description of medical uses of a claimed drug. Furthermore, generic drug manufacturers or other competitors may challenge the scope, validity or enforceability of our future owned and in-licensed patents, requiring us or our licensors to engage in complex, lengthy and costly litigation or other proceedings. Generic drug manufacturers may develop, seek approval for and launch generic versions of our products. It is also quite common that depending on the country, the scope of patent protection may vary for the same product candidate or technology.

The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or rules and regulations in the United States and Europe, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in other jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. Furthermore, while we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully commercialize our product candidates in all of our expected significant foreign markets. If we or our licensors encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished, and we may face additional competition from others in those jurisdictions.

Some countries also have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, some countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired.

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If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for our products, our business may be materially harmed.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our products are obtained, once the patent life has expired for a product, we may be open to competition from competitive medications, including generic medications. Given the amount of time required for the development, testing and regulatory review of new products, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from using or commercializing technologies or products similar or identical to ours.

Depending upon the timing, duration and conditions of FDA marketing approval of our product candidates, we may be able to extend the term of a patent covering each product candidate under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments and similar legislation in the EU. The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent that is applicable to and covers an approved drug may be extended. Similar provisions are available in Europe, such as supplementary protection certificates, and in certain other non-United States jurisdictions to extend the term of a patent that covers an approved drug. However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of a patent term extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced, possibly materially.

Further, under certain circumstances, the term of a patent covering our products may be extended for time spent during the pendency of the corresponding patent application in the USPTO (referred to as Patent Term Adjustment, or PTA). The laws and regulations underlying how the USPTO calculates the PTA is subject to change and any such PTA granted by the USPTO could be challenged by a third-party. If we do not prevail under such a challenge, the PTA may be reduced or eliminated, resulting in a shorter patent term, which may negatively impact our ability to exclude competitors.

Because PTA added to the term of patents covering pharmaceutical products has particular value, our business may be adversely affected if the PTA is successfully challenged by a third party and our ability to exclude competitors is reduced or eliminated.

Intellectual property rights do not address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:

● others may be able to make products that are similar to EOM613 and EOM147 or our future products or product candidates but that are not covered by the claims of the patents that we own or license from others;

● others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing our intellectual property rights;

● we or any of our collaborators might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own, license or will own or license;

● we or any of our collaborators might not have been the first to file patent applications covering certain technologies we or they own or have obtained a license, or will own or obtain a license;

● issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;

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● our competitors might conduct research and development activities in countries where we do not have patent rights, or in countries where research and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

● ownership and inventorship of our patents or patent applications may be challenged by third parties; and

● patents of third parties, or pending or future applications of third parties, if issued, may have an adverse effect on our business.

Our reliance on third parties requires us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.

We consider proprietary trade secrets or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value. Because we expect to rely on third parties to manufacture EOM 613 and EOM147 and any future products and product candidates, and we expect to collaborate with third parties on the development of EOM613 and EOM147 and any future products and product candidates, we must, at times, share trade secrets with them. We also conduct joint research and development programs that may require us to share trade secrets under the terms of our research and development partnerships or similar agreements. However, trade secrets or confidential know-how can be difficult to maintain as confidential.

To protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, consultants, collaborators, contractors and advisors to enter into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with us prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. However, current or former employees, consultants, collaborators, contractors and advisors may unintentionally or willfully disclose our confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. The need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations. Enforcing a claim that a third party obtained illegally and is using trade secrets or confidential know-how is expensive, time consuming and unpredictable. The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.

In addition, these agreements typically restrict the ability of our employees, consultants, collaborators, contractors and advisors to publish data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our unregistered trademarks or trade names. Over the long term, if we are unable to successfully register our trademarks and trade names and establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations.

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We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.

A third party may hold intellectual property, including patent rights that are important or necessary for the development or commercialization of EOM613 and EOM147 or our future products or product candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize EOM613 and EOM147 or our products or product candidates, in which case we would be required to obtain a license from these third parties. Such a license may not be available on commercially reasonable terms, or at all, which could materially harm our business. At this time, we are unaware of any intellectual property that interferes with ours or is complementary and needed to commercialize EOM613 and EOM147.

We may be subject to claims that our employees, consultants, collaborators contractors or advisors have wrongfully used or disclosed confidential information of their former employers or other third parties.

We employ individuals who were previously employed at other biotechnology or pharmaceutical companies. Although we seek to protect our ownership of intellectual property rights by ensuring that our agreements with our employees, consultants, collaborators, contractors, advisors and other third parties with whom we do business include provisions requiring such parties to assign rights in inventions to us, we may be subject to claims that we or our employees, consultants, collaborators, contractors and advisors have inadvertently or otherwise used or disclosed confidential information of their former employers or other third parties. We may also be subject to claims that the former employers or other third parties have an ownership interest in our patents. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.

Our proprietary information may be lost, or we may suffer security breaches.

In the ordinary course of our business, we collect and store sensitive data, including intellectual property, clinical trial data, proprietary business information, personal data and personally identifiable information of our clinical trial subjects and employees, in our data centers and on our networks. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Although, to our knowledge, we have not experienced any such material security breach to date, any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, significant regulatory penalties, disrupt our operations, damage our reputation and cause a loss of confidence in us and our ability to conduct clinical trials, which could adversely affect our reputation and delay our clinical development of our product candidates.

Risks Related to Our Employees, Managing Our Growth and Our Operations

Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.

We are highly dependent on the development, regulatory, commercialization and business development expertise of our senior management team, as well as the other principal members of our scientific and clinical teams. Although we have employment agreements, offer letters or consulting agreements with our executive officers, these agreements do not prevent them from terminating their services at any time.

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If we lose one or more of our executive officers or key employees, our ability to implement our business strategy successfully could be seriously harmed. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop product candidates, gain regulatory approval, and commercialize new products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these additional key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be engaged by entities other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain highly qualified personnel, our ability to develop and commercialize product candidates will be limited.

We expect to expand our development, regulatory, and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs, sales and marketing and financial and systems operations. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities or acquire new facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.

In the future, we may enter into transactions to acquire other businesses, products or technologies. If we do identify suitable candidates, we may not be able to make such acquisitions on favorable terms, or at all. Any acquisitions we make may not strengthen our competitive position, and these transactions may be viewed negatively by customers or investors. We may decide to incur debt in connection with an acquisition or issue our common stock or other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders. We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations into our existing business in an effective, timely and nondisruptive manner. Acquisitions may also divert management attention from day-to-day responsibilities, increase our expenses and reduce our cash available for operations and other uses. We cannot predict the number, timing or size of future acquisitions or the effect that any such transactions might have on our operating results.

Our business and operations would suffer in the event of system failures.

Our computer systems, as well as those of our CROs and other contractors and consultants, are vulnerable to damage from computer viruses, unauthorized access including ransomware attacks, natural disasters (including hurricanes), terrorism, war and telecommunication and electrical failures. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs. For example, the loss of preclinical or clinical trial data from completed, ongoing or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of EOM613 and/or EOM147 or any other product candidate could be delayed.

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We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary course of business, we collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. The size and complexity of our information technology systems, and those of our third-party vendors with whom we contract, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners or vendors, from attacks by malicious third parties, or from intentional or accidental physical damage to our systems infrastructure maintained by us or by third parties. Maintaining the secrecy of this confidential, proprietary, or trade secret information is important to our competitive business position. While we will take steps to protect such information and invested in information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms of deception, or for any other reason, could enable others to produce competing products, use our proprietary technology or information, or adversely affect our business or financial condition. Further, any such interruption, security breach, loss or disclosure of confidential information, could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on our business, financial position, results of operations or cash flow.

Risks Related to this Offering and Our Common Stock

Following this offering, our directors, executive officers and certain stockholders (a number of which are affiliates of our Founder and Chief Operating Officer) will continue to own a significant percentage of our common stock and, if they choose to act together, will be able to exert significant control over matters subject to stockholder approval.

Upon the closing of this offering, our Chairman and Chief Operating Officer, the Goldberger family and entities affiliated with them will beneficially own approximately _______% of the voting power of our outstanding common stock, or approximately ______% if the underwriters exercise their over-allotment option from us in full. As a result, they will have absolute control over the election of our directors and the outcome of corporate actions requiring stockholder approval, such as: (i) a merger or a sale of our company, (ii) a sale of all or substantially all of our assets, and (iii) amendments to our certificate of incorporation and bylaws. This concentration of voting power and control could have a significant effect in delaying, deferring or preventing an action that might otherwise be beneficial to our other stockholders and be disadvantageous to our stockholders with interests different from those entities and individuals. These individuals also have significant control over our business, policies and affairs as officers and directors of our company. Therefore, you should not invest in reliance on your ability to have any control over our company.

Because we are a startup and a smaller reporting company, the market price of our common stock will likely be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock in this offering.

Because we a startup with a limited track record, the market price of our common stock will likely be highly volatile. The market price of our common stock may be subject to wide fluctuations in response to a variety of factors, including the following:

● any delay in the commencement, enrollment and ultimate completion of our clinical trials;

● any delay in submitting an NDA and any adverse development or perceived adverse development with respect to the FDA’s review of that NDA;

● failure to successfully develop and commercialize EOM613 and EOM147 or any future product candidate;

● inability to obtain additional funding;

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● regulatory or legal developments in the United States and other countries applicable to EOM613 and EOM147 or any other product candidate;

● adverse regulatory decisions;

● changes in the structure of healthcare payment systems;

● introduction of new products, services or technologies by our competitors;

● failure to meet or exceed financial projections we provide to the public;

● failure to meet or exceed the estimates and projections of the investment community;

● changes in the market valuations of companies similar to ours;

● market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;

● announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors;

● significant lawsuits, including patent or stockholder litigation, and disputes or other developments relating to our proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

● additions or departures of key scientific or management personnel;

● sales of our common stock by us or our stockholders in the future;

● trading volume of our common stock;

● general economic, industry and market conditions;

● health epidemics and outbreaks, including the COVID-19 pandemic, which could significantly disrupt our preclinical studies and clinical trials, and therefore our receipt of necessary regulatory approvals could be delayed or prevented; and

● the other factors described in this “Risk Factors” section.

In addition, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These price fluctuations have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors, as well as general economic, political, regulatory and market conditions, may negatively affect the market price of our common stock, regardless of our actual operating performance. The market price of our common stock may decline below the public offering price, and you may lose some or all of your investment. In particular, stock markets have experienced extreme volatility in 2020 and 2021 due to the ongoing COVID-19 pandemic, among other factors, and investor concerns and uncertainty related to the impact of the pandemic on the economies of countries worldwide.

Our management has broad discretion in using the net proceeds from this offering.

We have stated, in only a general manner, how we intend to use the net proceeds from this offering. See “Use of Proceeds.” We cannot, with any assurance, be more specific at this time. We will have broad discretion in the timing of the expenditures and application of proceeds received in this offering. If we fail to apply the net proceeds effectively, we may not be successful in bringing our proposed products to market. You will not have the opportunity to evaluate all of the economic, financial or other information upon which we may base our decisions to use the net proceeds from this offering.

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We could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against companies following a decline in the market price of their securities. This risk is especially relevant for us because biotechnology companies have experienced significant share price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our common stock, our stock price and trading volume could decline.

The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts may publish about us or our business. We do not have any control over these analysts. If our financial performance fails, or our drug development program and clinical trial results do not meet analyst expectations or one or more of the analysts who cover us downgrade our common stock or change their opinion of our common stock, our share price would likely decline. If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.

Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.

We have never declared or paid any cash dividends on our common stock. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. As a result, capital appreciation, if any, of our common stock would be your sole source of gain on an investment in our common stock for the foreseeable future. See “Dividend Policy” for additional information.

If you purchase shares of our common stock in this offering, you will incur immediate dilution in the book value of your shares.

The public offering price of our common stock will be substantially higher than the as adjusted net tangible book value per share of our common stock. Therefore, if you purchase our common stock in this offering, you will pay a price per share of our common stock that substantially exceeds the book value of our net tangible assets after subtracting our liabilities. Based on the assumed public offering price of $____________ per share, you will experience immediate dilution of $__________ per share, representing the difference between our net tangible book value per share, after giving effect to this offering, and the public offering price. Further, the future exercise of any outstanding options and/or warrants to purchase shares of our common stock will cause you to experience additional dilution. See “Dilution.”

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

As a newly public company, we will incur significant legal, accounting and other expenses that we did not incur previously. The Sarbanes-Oxley Act of 2002 (“SOX”), the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq, and other applicable securities rules and regulations impose various requirements on U.S. reporting public companies, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our Board of Directors. In addition, these rules and regulations are often subject to varying interpretations, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. Pursuant to Section 404 of SOX (“Section 404”), we will be required to furnish a report by our senior management on our internal control over financial reporting in our next annual filing.

While we remain a smaller reporting company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. During our 2021 and 2020 audit examinations, our independent auditors identified material weaknesses in our internal controls principally due to the lack of segregation of duties for cash management. To mitigate this, we have hired an additional financial manager and engaged in various safeguards with our banks to insure cash management checks and balances. To prepare for eventual compliance with Section 404, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

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Anti-takeover provisions contained in our certificate of incorporation and bylaws, as well as provisions of Delaware law, could impair a takeover attempt.

Our certificate of incorporation, bylaws and Delaware law contain provisions which could have the effect of rendering more difficult, delaying or preventing an acquisition deemed undesirable by our Board of Directors. Our corporate governance documents include provisions:

● authorizing “blank check” preferred stock, which could be issued by our Board of Directors without stockholder approval and may contain voting, liquidation, dividend, and other rights superior to our common stock;

● limiting the liability of, and providing indemnification to, our directors and officers;

● controlling the procedures for the conduct and scheduling of Board of Directors and stockholder meetings; and

● providing our Board of Directors with the express power to postpone previously scheduled annual meetings and to cancel previously scheduled special meetings.

These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.

As a Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which generally prevents stockholders holding more than 15% of our outstanding common stock from engaging in certain business combinations without approval of the holders of substantially all of our outstanding common stock.

Any provision of our certificate of incorporation, bylaws or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock and could also affect the price that some investors are willing to pay for our common stock.

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CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

This prospectus, including the sections entitled “Prospectus Summary,” “Risk Factors,” “Use of Proceeds,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Business,” contains forward-looking statements. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following:

● our lack of operating history;

● fluctuations in the trading price of our common stock;

● the expectation that we will incur significant operating losses for the foreseeable future and will need significant additional capital following this offering;

● our current and future capital requirements to support our development and commercialization efforts for our product candidates and our ability to satisfy our capital needs;

● our dependence on our product candidates, which are still in preclinical or early stages of clinical development;

● our, or that of our third-party manufacturers, ability to manufacture cGMP quantities of our product candidates as required for pre-clinical and clinical trials and, subsequently, our ability to manufacture commercial quantities of our product candidates;

● our ability to complete required clinical trials for our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions;

● our lack of a sales and marketing organization and our ability to commercialize our product candidates if we obtain regulatory approval;

● our dependence on third-parties to manufacture our product candidates;

● our reliance on third-party CROs to conduct our clinical trials;

● our ability to maintain or protect the validity of our intellectual property;

● our ability to internally develop new inventions and intellectual property;

● interpretations of current laws and the passages of future laws;

● acceptance of our business model by investors;

● the accuracy of our estimates regarding expenses and capital requirements;

● our ability to adequately support organizational and business growth; and

● the continued spread of COVID-19 and the resulting global pandemic and its impact on our preclinical studies and clinical studies.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this prospectus. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in our forward-looking statements.

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You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements to actual results or to changes in our expectations, except as required by law.

You should read this prospectus and the documents that we reference in this prospectus and have filed with the Securities and Exchange Commission as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

USE OF PROCEEDS

We estimate that the net proceeds we will receive from the sale of our common stock in this offering, after deducting underwriting discounts and commissions and estimated expenses payable by us, will be approximately $________ million (or $______ million if the underwriters exercise their option to purchase additional shares in full), based on an assumed public offering price of $________ per share.

We currently expect to use the net proceeds from this offering for product development activities, including pre-clinical and regulatory research and development for our product candidates and future proposed clinical trials, and to repay approximately $687,500 (25%) of the principal on the outstanding convertible promissory note issued to one of our stockholders in the aggregate amount of approximately $2,751,000 which we have used for R&D drug development, our Brazilian clinical trial and general working capital. The convertible promissory note bears interest at a rate of 5% per annum and matures on November 24, 2023. We anticipate that the combined cost of preclinical animal studies and clinical trials for both drug candidates in the U.S and ex-U.S will be approximately $18-$21 million including regulatory and manufacturing costs. We anticipate using approximately $1 million to complete pre-clinical animal studies for EOM147. No proceeds are anticipated to be used for EOM613 pre-clinical animal studies. We also anticipate using approximately $8.5 million and $6.5 million respectively, to conduct U.S clinical trials for EOM613 and EOM147. In addition, we anticipate conducting additional ex-U.S. clinical trials for EOM147 which we estimate will cost $4.5 million. No proceeds from this offering will be used for ex U.S clinical trials for EOM613.

However, there can be no assurance that these costs will not increase due to macro-economic forces and trial delays outside of our control. The remainder of the net proceeds will be used for working capital and other general corporate purposes, including the associated costs of operating as a public company.

Based on our current projections, we believe the net proceeds of this offering will fund our operations for at least 12 months from the date of this prospectus.

We may also use a portion of the net proceeds of this offering for the acquisition or licensing, as the case may be, of additional technologies, other assets or businesses, or for other strategic investments or opportunities, although we currently have no understandings, agreements or commitments to do so.

Although we currently anticipate that we will use the net proceeds from this offering as described above, there may be circumstances where a reallocation of funds is necessary. The amounts and timing of our actual expenditures will depend upon numerous factors, including the results of our pre-clinical studies and planned clinical trials, our sales and marketing and commercialization efforts, demand for our products, our operating costs and the other factors described under “Risk Factors” in this prospectus. Accordingly, our management will have flexibility in applying the net proceeds from this offering. An investor will not have the opportunity to evaluate the economic, financial or other information on which we base our decisions on how to use the proceeds.

The net proceeds from this offering, together with our cash and marketable securities, will not be sufficient for us to fund any of our product candidates through regulatory approval, and we will need to raise additional capital to complete the development and commercialization of our product candidates. We estimate that we will need no less than $25 million of additional funding to obtain regulatory approval and achieve commercialization for our current product candidates. We can provide no assurance that we will be able to raise such funds on terms that are commercially acceptable to us, if at all.

Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and U.S. government securities.

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DIVIDEND POLICY

We have never declared or paid any cash dividends on our common stock. We intend to retain future earnings, if any, to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future. Investors should not purchase our common stock with the expectation of receiving cash dividends. Any future determination related to our dividend policy will be made at the discretion of our Board of Directors after considering our financial condition, results of operations, capital requirements, business prospects and other factors our Board of Directors deems relevant, and subject to the restrictions contained in any future financing instruments.

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CAPITALIZATION

The following table sets forth our cash and our capitalization as of March 31, 2022:

● on an actual basis; and

● on an as adjusted basis, giving effect to our issuance and sale of __________ shares of our common stock in this offering based on an assumed public offering price of $_______ per share, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

We derived this table from, and it should be read in conjunction with and is qualified in its entirety by reference to, our historical financial statements and the accompanying notes included elsewhere in this prospectus. You should read the following table together with our financial statements and the related notes appearing at the end of this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus. On December 1, 2021, we completed the acquisition of EOM Pharmaceuticals, Inc. The transaction was accounted for as a reverse merger, with EOM Pharmaceuticals, Inc. deemed to be the accounting acquirer and ImmunoCellular Therapeutics Ltd. deemed to be the legal acquirer. Accordingly, this table reflects the historical financial data of EOM Pharmaceuticals, Inc.

	As of March, 31
	2022
	Actual			As Adjusted
Cash	$	933,148
Non-Current Liabilities		2,775,664
Shareholders’ Equity (Deficit)
Preferred stock, $0.0001 par value, 5,000,000 shares authorized, no shares issued and outstanding actual; no shares issued and outstanding as adjusted as of March 31, 2022		-			-
Common stock, $0.0001 par value, 500,000,000 authorized, 113,270,751 issued and outstanding actual; shares issued and outstanding as adjusted as of March 31, 2022		11,327
Additional paid-in capital		4,974,842
Accumulated deficit		(7,387,302	)
Total Shareholders’ Equity (Deficit)		(2,401,133	)
Total Capitalization	$	374,531		$

Except as otherwise indicated herein, all information in this prospectus assumes:

● a 1-for-__ reverse stock split of our common stock; and

● no exercise of the outstanding options or warrants described above.

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be diluted immediately to the extent of the difference between the public offering price per share of our common stock and the as adjusted net tangible book value per share of our common stock immediately after this offering.

Dilution results from the fact that the public offering price per share is substantially in excess of the book value per share attributable to the existing stockholders for the presently outstanding shares of common stock. We calculate net tangible book value per share by dividing the net tangible book value (total tangible assets less total liabilities) by the number of outstanding shares of common stock.

Our historical net tangible book value as of March 31, 2022 was $(2,126,868), or $(0.02) per share of our common stock. Our historical net tangible book value is the amount of our total tangible assets less our total liabilities. Historical net tangible book value per share represents our historical net tangible book value deficit divided by the 113,270,751 shares of our common stock outstanding as of March 31, 2022.

After giving effect to the receipt of the estimated net proceeds from our sale of shares of common stock in this offering, based on an assumed public offering price of $___________ per share, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, our as adjusted net tangible book value at March 31, 2022 would have been approximately $________, or $_____ per share. This represents an immediate increase in net tangible book value per share of $_______ to existing stockholders and an immediate decrease in net tangible book value per share of $______ to you. The following table illustrates this dilution on a per share basis to new investors:

Assumed public offering price per share

Historical net tangible book value deficit per share as of March 31, 2022

Increase in net tangible book value per share attributable to this offering

As adjusted net tangible book value per share after this offering

Dilution per share to new investors purchasing common stock in this offering

If the underwriters’ over-allotment option is exercised in full, our as adjusted net tangible book value per share after this offering would be $_______ and dilution per share to new investors purchasing common stock in this offering would be $_______.

The table above is based on 113,270,751 shares of our common stock outstanding as of March 31, 2022 and does not include as of such date:

● 4,418,998 shares of common stock issuable upon exercise of warrants, at an exercise price of $0.60 per share; and

● 4,585,665 shares of common stock issuable upon the conversion, at the option of the Holder of our Convertible Promissory Note, at an exercise price of $0.60 per share.

● a 1-for-__ reverse stock split of our common stock; and

● no exercise of the outstanding options or warrants described above.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion summarizes the significant factors affecting the operating results, financial condition, liquidity and cash flows of our company as of and for the periods presented below. The following discussion and analysis should be read in conjunction with “Prospectus Summary—Summary Financial Information,” “Selected Financial Information” and the financial statements and the related notes thereto included elsewhere in this prospectus. The statements in this discussion regarding industry outlook, our expectations regarding our future performance, liquidity and capital resources and all other non-historical statements in this discussion are forward-looking statements and are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those discussed in or implied by forward-looking statements as a result of various factors, including those discussed below and elsewhere in this prospectus, particularly in the section entitled “Risk Factors.” This discussion and analysis are based upon the historical financial statements of EOM Pharmaceuticals, Inc, included in this prospectus. All references to years, unless otherwise noted, refer to our fiscal years, which end on December 31. On December 1, 2021, we completed the acquisition of EOM Pharmaceuticals, Inc. The transaction was accounted for as a reverse merger, with EOM Pharmaceuticals, Inc. deemed to be the accounting acquirer and ImmunoCellular Therapeutics Ltd. deemed to be the legal acquirer. All references to share and per share amounts of our common stock listed in this prospectus have been adjusted to give effect to the Reverse Stock Split.

Overview

We are a clinical stage pharmaceutical company that is focused on developing drugs with the potential to transform therapeutic paradigms and improve quality of life in patients suffering from debilitating and sometimes deadly diseases. We were founded with a specific vision to pursue innovative approaches to solving the problems of some of today’s urgent and medical needs. Our development efforts are focused on therapeutics with novel mechanisms of action that have shown promise in diseases with high need such as the hyperimmune response in severe COVID-19 patients, cancer cachexia for which no products have been approved in the U.S., rheumatoid arthritis, and inflammatory conditions of the retina characterized by a breakdown of the blood-retinal barrier. Our pipeline includes our lead compound EOM613, an investigational novel “dynamically dual-acting” immunomodulator. EOM613 is a peptide nucleic-acid solution with both anti-inflammatory and pro-inflammatory broad spectrum cytokine effects. Human cell culture studies demonstrate that EOM613 can suppress or stimulate monocytes and macrophages depending on the activation state and environment of those key immune cells resulting in either further activation or suppression.

Our lead clinical asset EOM613, is a broad spectrum immunomodulator investigational product, believed to have both anti-inflammatory and pro-inflammatory effects on cytokines and chemokines. In cell culture studies, EOM613 modulates a number of clinically important cytokines and chemokines, including IL-2, IL-6, IL-10, IL-12 MCP-1, TNF-alpha and interferon-gamma. This drug product is currently being evaluated in a multicenter, open-label Phase ½a clinical trial in Brazil to treat hospitalized COVID-19 patients who have the deleterious “cytokine storm”- related hyperimmune response to viral infection. Our Brazilian clinical trial is currently generating important information on cytokines and the effect of EOM613 treatment on the levels of these cytokines and the relevance to clinical effects. This information will increase the present information on EOM613’s mechanism of action and the relevance to various therapeutic areas. Additional studies are being planned to assess the drug product’s potential to improve the quality of life for persons with debilitating and potentially fatal diseases such as rheumatoid arthritis, and cachexia associated with advanced AIDS and cancers. These are all clinical conditions with enormous market potential. An immunomodulator drug candidate such as EOM613 also has potential in the treatment of a number of autoimmune disorders, where the immune system of certain individuals is dysregulated and aberrant.

Our second clinical stage asset, EOM147, is a new formulation of topical Squalamine Lactate solution eye drops. It is a novel therapeutic product which could provide a non-invasive therapy to improve vision outcomes beyond that achieved with current standard of care, or without requiring multiple intraocular injections directly into the eye for a variety of retinal disorders.

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We intend to conduct trials with a newly formulated and enhanced formulation of Squalamine Lactate eye drops for the treatment of wet-AMD as well for diabetic retinopathies and retinal vein occlusions. EOM147 is an improved, enhanced formulation designed to provide greater Squalamine concentrations as well as enhanced ocular retention and retinal retention uptake from front-of-the eye application as an eye drop for a potentially safer application. The new formulation utilizes FDA-approved additives to enhance absorption, through the use of our proprietary in-house technology. The new eye drop formulations will be subjected to preclinical evaluations for ocular uptake and safety and toxicology studies in order to corroborate their tolerability displayed by the prior formulations of squalamine lactate, based on the data from a prior Phase 2 clinical trial in wet-AMD which demonstrated a positive and clinically meaningful treatment effect of a 0.2% w/v Squalamine solution combination therapy in classic containing choroidal neovascularization (classic CNV) as well as those with occult neovascularization (occult CNV) less than 10mm². Additional proof-of concept investigator-initiated trials were also previously completed with the 0.2% w/v Squalamine drug product for other serious retinal disorders that lead to blindness, such as in proliferative diabetic retinopathy and in retinal vein occlusions with visual acuity benefits seen consistent with inhibition of retinal neovascularization. Once the safety of the novel formulations has been established in these preclinical animal studies, we expect to be able to proceed with our ophthalmological clinical trials.

On December 14, 2021, we entered into a Squalamine Lactate Route Selection, Development and Demonstration Agreement with Eurofins CDMO Alphora, Inc., a Canadian based Contract Research Organization to evaluate various synthetic routes to access Squalamine Lactate for purposes of further research and development of the Company’s EOM147 drug compound. The agreement is structured under a Phase 1 and Phase 2 work plan spanning over a ten-month period. The estimated aggregate cost under the agreement is approximately $1.3 million. In addition, on April 18, 2022, we entered into an agreement with Charles River Laboratories Montreal, LLC to conduct a comprehensive multi-animal toxicity study to assess the impact of our new squalamine formulation on intraocular eyedrop administration. The study is not expected to commence until the fourth quarter of 2022 or first quarter of 2023 depending on Charles River’s scheduling availability. The total cost of the study approximates $1.3 million. Our financial obligation will not commence until the study begins.

Merger with ImmunoCellular Therapeutics Ltd

Effective on December 1, 2021, we consummated the business combination (“Merger”) contemplated by the Agreement and Plan of Merger (the “Merger Agreement”), dated December 1, 2021, by and among EOM, ImmunoCellular Therapeutics Ltd., a Delaware corporation (“ImmunoCellular”), ImmunoCellular MergerSub Inc., a Delaware corporation and wholly-owned direct subsidiary of ImmunoCellular (“Merger Sub”), pursuant to which Merger Sub was merged with and into EOM, with EOM surviving the Merger. As a result of the Merger, EOM became a wholly-owned subsidiary of ImmunoCellular. Pursuant to the merger agreement, EOM shareholders exchanged all of their EOM common stock for newly issued shares of ImmunoCellular common and Series C convertible preferred stock. Post-merger, ImmunoCellular’s then current equity holders own approximately 3.5% and the former EOM equity holders own approximately 96.5% percent of ImmunoCellular’s common stock, calculated on a fully diluted basis.

COVID-19 Outbreak

On January 30, 2020, the World Health Organization announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 Outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 Outbreak as a pandemic, based on the rapid increase in exposure globally. The global COVID-19 pandemic has had, and may continue to have, a material impact on our business. Towards the end of the fourth quarter 2021 and continuing into the first quarter 2022, we experienced and continue to experience, an impact to our business in connection with our ongoing EOM613 clinical trial in Brazil. Due to ongoing numerous clinical studies in Brazil for various therapeutic treatments as well as the lack of available patients eligible for screening in accordance with the terms of our agreed upon trial protocol, we have experienced a delay in enrollment in our clinical trial. A continued delay in patient enrollment will delay our ability to collect and analyze critical scientific data on our drug candidate which may impact our ability to raise additional capital and our overall ability to continue our operations and business plan. As otherwise discussed above, the full impact of the COVID-19 Outbreak continues to evolve as of the date hereof. If the COVID-19 Outbreak continues, it may have a material adverse effect on the Company’s financial condition, liquidity, and future results of operations including our ability to conduct future clinical drug trials for our drug candidates. Management is actively monitoring the impact of the global pandemic on its financial condition, liquidity, operations, industry, and workforce.

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Components of Results of Operations for the Three-Months Ended March 31, 2022 and March 31, 2021

Operating expenses

Research and development expenses

Research and development costs are expensed as incurred. Our research and development expenses consisted primarily of direct costs associated with our COVID-19 Brazilian EOM613 clinical trial incurred by third party clinical research organizations, other medical institutions involved in ongoing trial activity as well as third party contract research organizations involved in further research and development efforts in the aggregate amount of $294,027 and $506,977, respectively for the three-month periods ended March 31, 2022 and 2021. We incurred $89,220 and $-0-, respectively of research and development costs associated with EOM147 through the three-month periods ended March 31, 2022 and 2021.

General and administrative expenses

General and administrative expense consists primarily of professional fees for legal and accounting services as well as other operating expenses.

Marketing and Advertising

Marketing and advertising costs are expensed as incurred and relate primarily to costs associated with developing our corporate website, investor relations and presentations, traditional and social media, corporate branding and messaging, and strategic communications and business development plans.

Comparison of the Three-Month Periods Ended March 31, 2022 and 2021

The following table sets forth or statement of operations for the following periods:

	Three-Months Ended March 31,						Change
	(Unaudited) 2022			2021			Dollars			Percentage
Operating expenses:
Research and development	$	383,247		$	506,977		$	(123,730	)		(24	)%
General and administrative		243,658			29,317			214,341			731	%
Salaries and benefits		129,130			114,034			15,096			13	%
Marketing & Advertising		39,565			356,600			(317,035	)		(89	)%
Total operating expenses		795,600			1,006,928			(211,328	)		(21	)%
Loss from operations		(795,600	)		(1,006,928	)		(211,328	)		(21	)%
Other income (expenses):
Interest income (expense), net		10,292			-			10,292			-	%
Total other income (expense)		10,292			-			10,292			-	%
Net loss	$	(785,308	)	$	(1,006,928	)	$	(221,620	)		(22	)%

Operating expenses

Research and development expenses

For the three months ended March 31, 2022, we recorded $383,247 of research and development expenses compared to $506,977 for the comparative three-month period ended March 31, 2021. The decrease of $123,730 during the three-month period ended March 31, 2022 related principally to a decrease of $212,950 in drug development and clinical trial costs associated with EOM613’s clinical trial in Brazil during the three-month period ended March 31, 2022 as compared to the three-month period ended March 31, 2021, offset by an increase of $89,220 of research and development costs incurred during the three-month period ended March 31, 2022 attributable to our retinal drug EOM147.

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General and administrative expenses

For the three-month period ended March 31, 2022, we incurred $243,658 of general and administrative expenses compared to $29,317 for the three-month period ended March 31, 2021 for an increase of $214,341 over the comparative three-month period. The increase in general and administrative expense for the three-month period ended March 31, 2022 compared to the three-month period ended March 31, 2021 is principally attributable to an increase in professional fees including legal, accounting and investment banking costs in the amount of $145,925 as well as an increase in insurance costs of $53,145.

Salaries and Benefits

For the three-month periods ended March 31, 2022 and 2021 we incurred $129,130 and $114,034, respectively, of salary and benefits costs or an increase of $15,096 period over period. The increase during the three-month period ended March 31, 2022 was primarily attributable to an additional salaried management personnel starting in February 2021 versus three months of salary and benefit costs during the three-month period ended March 31, 2022.

Marketing and Advertising

Marketing and advertising costs for the three-month periods ended March 31, 2022 and 2021 amounted to $39,565 and $356,600, respectively, or a decrease of $317,035. The decrease during the three-month period ended March 31, 2022 as compared to the three-month period ended March 31, 2021 was entirely attributable to a reduction in advertising and marketing costs associated with our drug products including a reduction in corporate messaging and presentation materials.

Other income (expenses)

Interest income (expense), net

For the three-month period ended March 31, 2022, we recorded $10,292 of net interest income compared to $-0- for the comparative three-month period ended March 31, 2021. The increase of $10,292 in net interest income is comprised of $41,112 of interest income attributable to the amortization of debt premium on our Convertible Promissory Note and $19 of other interest income, offset by accrued interest of $30,839 on our Convertible Promissory Note.

Cash Flow Summary for the Three-Month Periods Ended March 31, 2022 and March 31, 2021

The following table shows a summary of our cash flows for each of the periods shown below:

	Three-Months Ended
	March 31, 2022			March 31, 2021
Net cash used in operating activities	$	(553,418	)	$	(592,972	)
Net cash provided by financing activities		—			500,000
Net increase (decrease) in cash	$	(553,418	)	$	(92,972	)

Operating activities

During the three-month period ended March 31, 2022, operating activities used $553,418 of cash, primarily resulting from a net loss of $785,308 decreased by an increase in prepaid expenses in the amount of $10,268, an increase of $262,734 in accounts payable and accrued expenses offset by $41,112 in debt premium on our Convertible Promissory Note.

During the three-month period ended March 31, 2021, operating activities used $592,972 of cash, primarily resulting from a net loss of $1,006,928, decreased by an increase of $413,956 in accounts payable and accrued expenses.

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Investing activities

During the three-month periods ended March 31, 2022 and March 31, 2021, there were no investing activities.

Financing activities

During the three-month period ended March 31, 2022 no funds were provided by financing activities while during the three-month period ended March 31, 2021, $500,000 of funds were provided in connection with the related party Bridge Note facility.

Commitments and Contingencies

See Notes 8 and 9 respectively, Commitments and Contingencies, of the notes to our unaudited interim condensed consolidated financial statements for the three-month periods ended March 31, 2022 and 2021 and our audited consolidated financial statements as of and for the year ended December 31, 2021, and for the period from March 27, 2020 (Inception) through December 31, 2020 included elsewhere for further discussion of our contractual obligations.

Results of operations for the year ended December 31, 2021 and the period from March 27, 2020 (Inception) through December 31, 2020

The following table sets forth our statements of operations data for the following periods:

							Change
	Year Ended December 31, 2021			Period from March 27, 2020 (Inception) To December 31, 2020			Dollars			Percentage
Operating expenses:
Research and development	$	1,301,437		$	696,718		$	604,719			87	%
General and administrative		308,433			107,968			200,465			186	%
Salaries and benefits		449,567			174,306			275,261			158	%
Marketing & Advertising		554,025			474,000			80,025			17	%
Total operating expenses		2,613,462			1,452,992			1,160,470			80	%
Loss from operations		(2,613,462	)		(1,452,992	)		1,160,470			80	%
Other (income) expenses:
Interest expense, net		8,462			0			(8,462	)		-	%
Loss on debt extinguishment		2,527,078			0			(2,527,078	)		-	%
Total other (expense)		(2,535,540	)		0			(2,535,540	)		-	%
Net loss	$	(5,149,002	)	$	(1,452,992	)	$	3,696,010			254	%

Operating expenses

Research and development expenses

For the year ended December 31, 2021, we recorded $1,301,437 of research and development expenses compared to $696,718 for the period from March 27, 2020 (Inception) through December 31, 2020. The increase of $604,719 related entirely to an increase in clinical trial and drug development expenses in connection with our EOM613 Phase 1/2a open-label clinical trial in Brazil including $465,685 of CRO costs associated with the commencement of the above clinical trial. No material drug development costs for EOM147 were incurred either during the year ended December 31, 2021, or for the period from March 27, 2020 (Inception) through December 31, 2020.

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General and administrative expenses

For the year ended December 31, 2021, we incurred $308,433 of general and administrative expenses compared to $107,968 for the period from March 27, 2020 (Inception) through December 31, 2020. The increase of $200,465 related to an increase in professional fees including legal, accounting and investment banking costs in the amount of $204,663, reduced by a decrease in other general and administrative costs of $14,542 increased by $10,344 in general and trial insurance expense.

Salaries and Benefits

For the year ended December 31, 2021, we incurred $449,567 of salaries and benefit expense compared to $174,306 for the period from March 27, 2020 (Inception) through December 31, 2020. The increase of $275,261 was entirely attributable to additional management personnel commencing in January 1, 2021 combined with a full year versus eight months of costs.

Marketing and Advertising

Marketing and advertising costs for the year ended December 31, 2021, and the period from March 27, 2020 (Inception) through December 21, 2020 were $554,025 and $474,000 respectively. The increase of $80,025 for the year ended December 31, 2021, as compared to the period from March 27, 2020 (Inception) through December 31, 2020 was attributable to additional marketing and corporate messaging services in advance of and during our COVID-19 Brazilian clinical trial.

Other (income) expenses

Interest expense, net

For the year ended December 31, 2021, we recorded $8,462 of net interest expense compared to $-0- for the period from March 27, 2020 (Inception) through December 31, 2020. The increase of $8,462, is net of $17,224 of interest income attributable to the amortization of debt premium on our November 24, 2021 Convertible Promissory Note and $13 of other interest income offset by an increase in accrued interest of $12,815 on our April 7, 2021, Bridge Note facility, and $12,884 of accrued interest on our Convertible Promissory Note. 

Loss on Debt Extinguishment

For the year ended December 31, 2021 we recorded a loss of $2,527,078 on the extinguishment of our related party Bridge Note Facility compared to $-0- for the period from March 27, 2020 (Inception) through December 31, 2020.

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Liquidity and Capital Resources

We have generated no revenues, have incurred operating losses since inception, and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. We have an accumulated deficit of $7,387,302 as of March 31, 2022, and future losses are anticipated. These factors, among others, raise substantial doubt as to our ability to obtain additional debt or equity financing and our ability to continue as a going concern. Until such time as we are able to establish a revenue stream from the sale of our therapeutic products, we are dependent upon obtaining necessary equity and/or debt financing to continue operations. We cannot make any assurances that sales of our drug products will commence in the near term or that additional financings will be available to us and, if available, on acceptable terms or at all. To date, we have been funded entirely by the majority shareholder’s family. There can be no assurance that the majority shareholder’s family will continue to fund our operations on favorable terms or at all. Moreover, there can be no assurance that we will be able to secure the necessary debt or equity financings to continue our drug development and clinical trial plans at all or on terms acceptable to us. This could negatively impact our business and operations and could also lead to the reduction of our business and drug development operations. Consequently, the accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Accordingly, there are material risks and uncertainties that raise substantial doubt about our ability to continue as a going concern within one year from the date these financial statements are available to be issued. These financial statements do not include any adjustments relating to the recovery of recorded assets or the classification of the liabilities that might be necessary should we be unable to continue as a going concern.

Reverse Recapitalization Merger With ImmunoCellular Therapeutics Ltd.

Effective on December 1, 2021, we consummated the business combination (“Merger”) contemplated by the Agreement and Plan of Merger (the “Merger Agreement”), dated December 1, 2021, by and among EOM, ImmunoCellular Therapeutics Ltd., a Delaware corporation (“ImmunoCellular”), ImmunoCellular Merger Sub Inc., a Delaware corporation and wholly-owned direct subsidiary of ImmunoCellular (“Merger Sub”), pursuant to which Merger Sub was merged with and into EOM, with EOM surviving the Merger. As a result of the Merger, EOM became a wholly-owned, direct subsidiary of ImmunoCellular. As a result of the Merger, ImmunoCellular intends to change its name to EOM Pharmaceuticals Holdings, Inc.

Pursuant to the merger agreement, EOM shareholders exchanged all of their EOM common stock for newly issued shares of ImmunoCellular common and Series C convertible preferred stock. Post-merger, ImmunoCellular’s then current equity holders own approximately 3.5% and the former EOM equity holders own approximately 96.5% percent of ImmunoCellular’s common stock, calculated on a fully diluted basis.

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Pursuant to the terms of the Merger Agreement, we issued a Convertible Promissory Note (the “Note”) dated November 24, 2021 in the amount of up to $5.0 million to a related party principal stockholder. Under the terms of Note, the related party stockholder advanced $1 million to the Company immediately prior to closing and committed to provide additional funding up to an additional $2.5 million over the two-year term of the Note. The Note has an interest rate of 5% and is payable semi-annually without prepayment penalty. Under the terms of the Note, the related party agreed to transfer the amount due under the Bridge Note Facility of $1,501,399 to the principal of the Note with the Bridge Note Facility becoming null and void. At Merger closing, the then-principal amount due under the Note amounted to $2,501,399 which included the unpaid principal amount of the Bridge Note Facility of $1,501,399 and the $1,000,000 advanced under the Note. The Note is convertible into common stock of the Company at any time at the option of the holder thereof at an initial price of $1.30 per share, the agreed upon pre-merger value of EOM. As a result of the merger, the conversion price was subsequently adjusted to $0.60, which equals the pre-close price of ImmunoCellular’s common stock as traded on the Pink Sheets of the OTC Markets. The number of shares the Convertible Promissory Note is exchangeable into was also adjusted to the pre-closing price of $0.60 per share for a total of 4,168,998 shares of common stock. The conversion price will be adjusted further in the event of stock splits, stock dividends and other similar transactions.

The Note also provides us the right, but not the obligation, to prepay up to 25% of the principal amount of the outstanding balance in the event we receive gross proceeds of no less than $10 million from the sale of common stock.

Cash Flow Summary for the year ended December 31, 2021 and from March 27, 2020 (Inception) to December 31, 2020

The following table shows a summary of our cash flows for each of the periods shown below:

	Year Ending December 31, 2021			Period from March 27, 2020 (Inception) to December 31, 2020
Net cash used in operating activities	$	(2,306,385	)	$	(1,237,021	)
Net cash provided by financing activities		3,529,972			1,500,000
Net increase (decrease) in cash	$	1,223,587		$	262,979

Operating activities

During the year ended December 31, 2021, operating activities used $2,306,385 of cash, primarily resulting from a net loss of $5,149,002 decreased by an increase in prepaid expenses in the amount of $13,372, an increase in loss on debt extinguishment of $2,527,078, an increase of $319,391 in accounts payable and accrued expenses offset by an increase in amortization of debt premium of $17,224 on our Convertible Promissory Note.

During the period from March 27, 2020 (Inception) to December 31, 2020, operating activities used $1,237,021 of cash, primarily resulting from a net loss of $1,452,992, decreased by a non-cash charge of $78,843 from the issuance of Founders stock in exchange for intellectual property, and an increase of $137,128 in accounts payable and accrued expenses.

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Investing activities

During the year ended December 31, 2021, and for the period from March 27, 2020 (Inception) to December 31, 2020 there were no investing activities.

Financing activities

During the year ended December 31, 2021, financing activities provided $3,529,972 of cash, principally from $1,501,399 of funds borrowed under the April 7, 2021 Bridge Note facility, $1,000,000 of funds borrowed under the November 24, 2021 related party Convertible Promissory Note, 1,024,848 of cash, net of transaction costs in connection with our Merger with EOM Pharmaceuticals Inc. on December 1, 2021, and $3,725 from the payment of previously issued Founders shares.

During the period from March 27, 2020 (Inception) through December 31, 2020, financing activities provided $1,500,000 of cash solely from the issuance of Founder’s shares.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of its financial condition and results of operations is based on its financial statements, which have been prepared in accordance with GAAP. The preparation of our consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheet and the reported amounts of expenses during the reporting period. In accordance with GAAP, we the evaluate our estimates and judgments on an ongoing basis. The most significant estimates relate to the valuation allowance of deferred tax assets resulting from net operating losses as well as the determination of the fair value and debt premium on our Convertible Promissory Note. We base our estimates and assumptions on current facts, historical experiences, and various other factors that the Company believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We define our critical accounting policies as those accounting principles that require it to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on its financial condition and results of operations, as well as the specific manner in which we apply those principles. While our significant accounting policies are more fully described in Note 1 to our audited consolidated financial statements, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments.

Research and Development Expenses

Research and development costs include costs incurred for external research and development activities to develop drug candidates and are expensed as incurred in the accompanying statement of operations. Research and development costs consist of, when applicable, external laboratory supplies and facility costs, as well as fees paid to third party entities that conduct certain research and development activities on our behalf.

We record accrued liabilities for incurred cost of research and development activities conducted by service providers, which include activities under agreements with various Contract Research Organizations for preclinical and clinical studies and contract manufacturing activities. We record the costs of research and development activities based upon the number of services provided and includes these costs in accrued and other current liabilities in the accompanying balance sheet and within research and development expense in the accompanying interim condensed statement of operations.

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Net Loss per Share of Common Stock

Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options and restricted stock units are considered to be potentially dilutive securities. Because we have reported a net loss for the three-month periods ended March 31, 2022 and March 31, 2021 as well as for the year ended December 31, 2021, and for the period from March 27, 2020 (Inception) through December 31, 2020, diluted net loss per common share is the same as basic net loss per common share for these periods.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective is not expected to have a material impact on our financial position or results of operations upon adoption.

In February 2016, the Financial Accounting Standards Board (FASB) issued ASU 2016-02, Leases (Topic 842), with guidance regarding the accounting for and disclosure of leases. The update requires lessees to recognize the liabilities related all leases, including operating leases, with a term greater than 12 months on the balance sheet. This update also requires lessees and lessors to disclose key information about their leasing transactions. This guidance will be effective for public companies for annual and interim periods beginning after December 15, 2018. For all other entities, this standard is effective for annual reporting periods beginning after December 15, 2021, early adoption is permitted. We adopted Topic 842 effective January 1, 2022. As we had no lease obligations as of December 31, 2021 there was no impact on our consolidated financial statements or financial statement disclosures.

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This guidance is intended to improve consistent application and simplify the accounting for income taxes. This ASU removes certain exceptions to the general principles in Topic 740 and clarifies and amends existing guidance. This standard is effective for annual reporting periods beginning after December 15, 2020, including interim reporting periods within those annual reporting periods, with early adoption permitted. We have adopted ASU No. 2019-12 for the calendar year ended December 31, 2021, with such adoption having no material impact on our consolidated financial statements.

In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)-Accounting For Convertible Instruments and Contracts in an Entity’s Own Equity. The ASU simplifies accounting for convertible instruments by removing major separation models required under current GAAP. Consequently, more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion features. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for it. The ASU also simplifies the diluted net income per share calculation in certain areas. The new guidance is effective for annual and interim periods beginning after December 15, 2021, and early adoption is permitted for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. We adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have a material impact on our consolidated financial statements.

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BUSINESS

Summary

We are a clinical-stage pharmaceutical company focused on the development of therapeutics and delivery technologies for the treatment of inflammatory conditions and ocular disease. Our development pipeline consists of multiple programs and clinical indications at various stages of development.

Our lead clinical asset is EOM613 solution, a broad spectrum immunomodulator investigational product, and, based on past clinical data, is believed to have both anti-inflammatory and pro-inflammatory effects on cytokines and chemokines. In cell culture studies, EOM613 modulates a number of clinically important cytokines and chemokines, including IL-2, IL-6, IL-10, IL-12 MCP-1, TNF-alpha and interferon-gamma. This drug product is currently being evaluated in a multicenter, open-label Phase 1/2a clinical trial in Brazil to treat hospitalized COVID-19 patients who have the deleterious “cytokine storm”- related hyperimmune response to viral infection. Additional subsequent studies are being planned to assess the drug product’s potential to improve the quality of life for persons with debilitating and potentially fatal diseases such as rheumatoid arthritis, and cachexia associated with advanced AIDS and cancers. We believe that these are clinical conditions with enormous market potential. An immunomodulator drug candidate such as EOM613 also has potential in the treatment of a number of autoimmune disorders, where the immune system of certain individuals is dysregulated and aberrant.

Our second clinical stage asset, EOM147, a new formulation of topical Squalamine Lactate solution eye drops. It is a novel therapeutic product which could provide a non-invasive therapy to improve vision outcomes beyond that achieved with current standard of care, or without requiring multiple intraocular injections directly into the eye for a variety of retinal disorders.

We intend to conduct trials in 2023 with newly enhanced formulation of Squalamine Lactate eye drops for the treatment of wet-AMD as well for diabetic retinopathies and retinal vein occlusions. EOM147 is an improved, enhanced formulation; designed to provide greater squalamine concentrations as well as enhanced ocular retention and retinal retention uptake from front-of-the eye application as an eye drop. The new formulation utilizes FDA-approved additives to enhance absorption, through the use of our proprietary in-house technology. The new eye drop formulations will be subjected to preclinical evaluations for ocular uptake and safety and toxicology studies in order to corroborate their tolerability displayed by the prior formulations of squalamine lactate based on the data from a Phase 2 clinical trial in wet-AMD which demonstrated a positive and clinically meaningful treatment effect of a 0.2% w/v Squalamine solution combination therapy in classic containing choroidal neovascularization (classic CNV) as well as those with occult neovascularization (occult CNV) less than 10mm². Additional proof-of concept investigator-initiated trials were also previously completed with the 0.2% w/v squalamine drug product for other serious retinal disorders that lead to blindness, such as in proliferative diabetic retinopathy and in retinal vein occlusions with visual acuity benefits seen consistent with inhibition of retinal neovascularization. Once the safety of the novel formulations has been established in these preclinical animal studies, we expect to be able to proceed with our ophthalmological clinical trials

We envision conducting future Phase II trials with a new formulation of EOM147 in wet AMD in India, and in macular edema secondary to diabetic retinopathies in India and Mexico, together with trials in retinal vein occlusions and in proliferative diabetic retinopathy in the US. We further intend to conduct future Phase II trials with a new formulation of EOM147 in wet AMD in India, and in macular edema secondary to diabetic retinopathies in India and Mexico, together with trials in retinal vein occlusions and in proliferative diabetic retinopathy in the US.

Product Pipeline

EOM613 Solution for Injection

We acquired EOM613 from Neubase Therapeutics, the successor company to OHR Pharmaceutical, Inc., which had previously developed the drug product (under the name OHR/AVR118 solution) for the treatment of AIDS and cancer cachexia. The rights to the EOM613 INDs 62994 and 69518 and related data related to the drug product were transferred by Neubase Pharmaceuticals to Dr. Shalom Hirschman, one of our co-founders, on May 22, 2020. He transferred the rights over to us in exchange for Founder’s stock having a value of $78,843. No monetary exchanges occurred for these transactions. No unexpired patents or other intellectual property were transferred.

Cachexia is the wasting syndrome in advanced cancer and AIDS patients that leads to severe muscle wasting and debilitation. It is largely driven by release of deleterious pro-inflammatory biochemical molecules called cytokines and chemokines that are released within the body as a result of these clinical conditions.

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EOM613 is a peptide nucleic acid solution that is believed to have both pro- and anti-inflammatory effects on cytokines and chemokines. In human cell line culture studies, EOM613 has demonstrated a unique “dynamic dual action” by suppressing or stimulating monocytes or macrophages, based upon the specific activation state and specific bodily environment of those immune cells. It is hypothesized that this dynamic dual action may in fact overcome the key limitation of many approved immunomodulator drugs that only reduce the inflammatory state, without restoring a state of immune balance. Therefore, other classes of drugs such as corticosteroids suppress the immune system to such a degree that they can open the body up to secondary infections while suppressing inflammation. (S.Z. Hirchman, Advances in Bioscience and Biotechnology 5 (2014) 161-168).

EOM613 (previously known as Reticulose, Product R, OHR118 and AVR118), is an investigational, dynamically dual-acting immunomodulator. EOM613 is a peptide-nucleic acid (PNA) mixture containing two peptides and 13 nucleotides/nucleosides – a synthetic analog comprised of nucleobases arrayed along a pseudopeptide backbone. It combines the power of nucleic acids to encode information with the versatility of amino acids to encode structure and function. Specifically, peptide A has 31 amino acids, and peptide B has 21 amino acids with diadenine dinucleotide attached.

While the exact mechanism of action of EOM613 is not yet fully understood, it appears to have both pro- and anti-inflammatory effects depending on the activation state of immune cells, consistent with the meaning of dynamic dual action. As noted above, nucleic acid-based molecules are known to simultaneously mimic both a peptide and a nucleic acid. Further, studies have shown that modulation of the pathogenic T-cell response with antigen-specific peptide immunotherapy offers the potential to restore the immune homeostasis and prevent further tissue destruction. Studies of the effect of EOM613 on the immune response are consistent with these findings. The studies are reported from two separately published reports of a series of in vitro human cell culture studies by Lazzarino et al. and Hirschman. One of the studies by Lazzarino et al. (D.A. Lazzrino, et al., Cytokine, 2001, 14:234-239) showed that EOM613 enhanced the cytokines IL-8 and MCP-1 secretion by unstimulated adherent PBMCs, but in lipopolysaccharide (“LPS”) stimulated peripheral blood monocyte cells (PBMCs), it only slightly increased the cytokine MCP-1 production. Therefore, the action of EOM613 on cells of the immune system appears to be linked to both the cell type and its specific state of activation.

In another study by Hirschman, (SZ Hirschman, Adv. Biosc. Biotechnol., 5: 161-168) EOM613 stimulated a pro-inflammatory response of increased IL-6 secretion by U937 cells (a cell line of myeloid monocyte lineage) moderately activated with phorbol myristate acetate (PMA). However, after those cells were further activated by LPS, EOM613 produced an anti-inflammatory response by reducing IL-6 secretion.

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In activated U937 cell lines of a monocyte lineage, EOM613 induced an anti-inflammatory phenotype, as indicated by reduced phagocytosis and increased IL-10 chemokines including secretion. Other studies showed the ability of EOM613 to upregulate or downregulate various other cytokines and IL-6, Il-12, TNF-alpha and interferon gamma based on the immune cell type and/or its activation state.

This dual immunomodulatory action exhibited by EOM613 based on the specific activation status of the cells in the immune system may offer us distinct advantages over conventional immunomodulator drugs. Corticosteroid drugs, that are the usual mainstay today in the physician’s arsenal to suppress hyperimmune reactions in the body, suppress the immune system across the board in the entire body. They therefore produce serious side-effects and may open the patient to contracting serious secondary bacterial or fungal infections upon prolonged therapy. By virtue of its novel dual immune modulatory actions on both pro- and anti-inflammatory cytokines and chemokines, EOM613 does not have this propensity, and has been used clinically in the past, being well tolerated by patients.

We believe it has become increasingly clear that, while attenuating the inflammatory response is necessary in treating many disorders – and critical in patients suffering from cytokine storms associated with COVID-19 – maintaining a balance of pro- and anti-inflammatory action is also fundamentally important. Dynamically dual-acting immunomodulators such as EOM613 can have an anti-inflammatory effect specifically at the site of excessively overactive pro-inflammatory cytokines and chemokines, and a pro-inflammatory effect when needed to restore physiological balance or fight an infection. Given the involvement of hyperinflammatory states in many diseases and disorders (e.g., severe COVID-19, cancer- and AIDS-associated cachexia, rheumatoid arthritis and other autoimmune disorders, sepsis, and others), the potential use of dynamically dual-acting immunomodulators such as EOM613 could be broad indeed.

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Past Clinical Trials of EOM613

EOM613 has a development program supported by previous early clinical stage safety and efficacy data garnered in over 100 patients across multiple therapeutic indications associated with hyperimmune responses, including clinical trials in AIDS cachexia, cancer cachexia and rheumatoid arthritis. The table below provides an overview of previously concluded clinical trials with EOM613. In past clinical trials, the drug product has been well-tolerated by patients as a subcutaneous injection dosing. In the cancer cachexia trials, dosing extended to 52 consecutive daily doses of treatment.

DISEASE SOURCE	STUDY TYPE AND DESIGN		# OF PATIENTS		EFFICACY FINDINGS		SAFETY/TOLERABILITY FINDINGS
HIV/AIDS1	●	Phase 1/2, randomized, double-blind, placebo-controlled trial	●	43 (21 EOM613, 22 placebo)	●	CD4 lymphocyte counts increased vs baseline more in EOM613 group vs placebo group (p=0.013)	●	EOM613 injections generally well tolerated
	●	Conducted in Barbados			●	4 EOM613 patients (but no placebo patients) had significant viral load declines	●	Some patients reported transient mild pain at injection site
					●	Body weight increased vs baseline in EOM613 group (p=0.003) whereas placebo group had a mean weight loss (p=0.003 for group difference)	●	No toxic effects of EOM613 reported by patients or observed by physicians
Rheumatoid Arthritis (RA)2	●	Phase 2, open-label trial	●	27 patients who met American College of Rheumatology criteria for mild to moderately severe RA	After the 3 months of EOM613 therapy, all patients:		●	No major side effects observed or reported
	●	Patients given EOM613 I mL twice daily for 15 days, then once daily for 75 days			●	Responded with amelioration of symptoms	●	All patients considered tolerability as excellent
	●	Conducted in Argentina			●	Had a significant decreases in joint pain
					●	Had increased mobility of the joints
					●	Showed objective signs of decreased inflammation of affected joints
					●	Considered efficacy as excellent
Cancer Cachexia3	●	Phase 2, open-label trial	●	29 enrolled patients with advanced cancer and cachexia	●	Stabilization of weight, lean body mass and body fat	●	EOM613 was well tolerated with minimal side effects
	●	Conducted in Canada			●	Appetite increased (p=0.00) and total PG-SGA scores improved significantly (p=0.025)
					●	Enhanced quality of life and Karnofsky Performance Status

* In these and other past reports, EOM613 has had other names, including Product R, OHR118, AVR118, and OHR/AVR118.

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HIV-1 (AIDS) Trial in Barbados

This randomized, placebo-controlled trial was conducted by the company that originally developed the drug product, Advanced Viral Research Corporation at the University of West Indies School of Clinical Medicine and Research, Queen Elizabeth Hospital, Bridgetown, Barbados, between 2001-2002, with Dr. Paul N. Levett as the Principal Investigator. HIV-1 positive patients naïve to any prior retroviral treatments were randomized to receive EOM613 (then referred to as Product R). A total of 43 patients were enrolled; 21 received Product R and 22 received placebo solution subcutaneously injected. The dosage was two 1 mL solution injections daily on days 1-14, followed by 1 mL daily on days 22-28, days 36-42 and 50-56. The follow-up period lasted until Day 120. The results of the study indicated that mean CD4 lymphocyte counts increased in the drug product-treated group was significant higher (p= 0.013) than in the placebo-control group by the end of follow-up. Four of the drug-treated patients experienced declines in viral load of >0.5 log., while none of the placebo-treated patients did. At the end of the follow-up period, the Product R-treated patients experienced a mean weight gain (p= 003) while the placebo group experienced a mean weight loss. The number of deaths and opportunistic infections were lower in the drug-treated group as compared to placebo group (p=0.076). No drug-related toxic effects were reported, and the drug product was generally well-tolerated with some patients experiencing mild pain at the injection site. The study results were published in the medical literature – P.N. Levett et al., HIV Clin Trials, 2002, 3:272-278. The trial results were sufficient to advance the product candidate to a subsequent clinical trial for the indication being evaluated.

Rheumatoid Arthritis Exploratory Trial in Argentina

An open label pilot study in rheumatoid arthritis (RA) patients was conducted at a rheumatology clinic in Buenos Aires, Argentina, under the sponsorship of Advanced Viral Research Corporation in 1999-2000. A total of 27 patients, ranging in age from 29 to 50 years old, were recruited into the study, who had confirmed diagnosis of mild to moderate RA of less than two years’ duration and met the American College of Rheumatology criteria for that stage of the disease. Most patients had impaired mobility of joints in hands; three also had impaired joints in their feet. Patients were treated with a 90-day treatment protocol, being given a subcutaneous injection of Product R, 1 mL twice a day for the first 15 days, then 1 mL once a day for the subsequent 75 days. Patient self-assessment for spontaneous pain at baseline were 7 reporting no pain, 8 reporting mild pain and 12 reporting moderate pain. By day 30 the scoring was 11 reporting no pain, 12 reporting mild pain and 5 reporting moderate pain. On day 60, the scoring was 17 reporting no joint pain, 10 reporting mild pain and none reporting moderate pain. At study’s end on Day 90, the scoring was 23 patients reporting no pain, and 4 with mild pain, with none reporting moderate pain.

When pain caused by applied pressure on the affected joints was evaluated; likewise, there were improvements in pain scores as the treatment progressed. At baseline none reported mild pain, 15 reported moderate pain and 12 reported severe pain. At Day 30, 11 reported mild pain, 15 reported moderate pain and one severe pain. At day 60, the scoring was 15 reporting mild pan, 12 moderate pain and none severe pain. At the study end on day 90, the score was 25 patients exhibiting mild pain and 2 moderate pain, with none exhibiting severe pain. All patients also showed objective signs of decreased inflammation of the affected joints as manifested by joint tumefaction. Increased joint mobility was also evident upon treatment.

The drug product was well-tolerated, with only one patient reporting pain at the site of injection on day 90, which lasted two days and resolved by itself. The trial results were sufficient to advance the product candidate to a subsequent clinical trial for the indication being evaluated.

Phase II Cancer Cachexia Study

A Phase II open label study of EOM613 (then known as AVR/OHR118) in cancer-related anorexia-cachexia was conducted by Ohr Pharmaceuticals, Inc. under a Health Canada IND at the McGill University Center and the University of Ottawa Cancer Center, under the stewardship of Dr. Martin Chasen, who served as Principal Investigator. A total of 29 patients were enrolled in this trial (NCT01206335), of which 18 completed the trial. The trial’s purpose was to determine the safety and effects of OHR/AVR118 on appetite and symptoms of anorexia-cachexia I patients with advanced cancers. Primary outcome measures included Functional Status/Quality of Life as measured by the Simmonds Functional assessment, Appetite and satiation as measured by patient-generated subjective global assessment (PG-SGA) scoring, the Edmonton Symptom assessment scale (ESAS), Dyspepsia symptom severity index (DSSI), weight gain or stabilization and increase in lean body mass. Inclusion criteria incorporated patients aged 18 through 85, with a histologically confirmed solid tumor, lymphoma, leukemia or multiple myeloma, with symptoms of recurrent or metastatic cancer with anorexia and/or cachexia, a Karnofsky performance score of >40%, a palliative prognostic score of <6, and a patient expected to be able to remain on the protocol for at least 2 calendar months. Patients received a total of 4.0 mL of the drug product in two daily subcutaneous doses of 2 mL each. Patients received bimonthly evaluations during the initial 28-day treatment period (Phase A). Patients who benefited from and chose to could extend the treatment period to a second 28-day period (Phase B), for a total of a 56-day drug treatment. Of the 29 enrolled patients, 18 completed the protocol; 15 with Stage IV cancers and three with Stage III cancers. Of the completed patients, there were 15 male and 3 female patients, 11 >65 years old and 7 in the age group of 18-64. Of the 18 patients who completed the Phase 1 treatment period, 11 chose to extend treatment beyond the initial 28 days into the second 28-day treatment period. Eight of these 11 completed the Phase B treatment. A total of 7 patients remained on active chemotherapy during the trial and one patient continue radiation treatments.

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At Day 28, for the 18 patients completing the protocol, on the symptom severity assessment ESAS scale, appetite scores decreased from a mean of 7.2 at the baseline to a value of 5.8 (p<0.005). The cumulative PGSGA score decreased from a mean value of 10.9 at the baseline to a value of 7.7 (p = 0.025), indicating statistically significant symptom improvement Overall DSSI scores improved from a baseline value of 1.45 to 0.75 after 4 weeks. Mean total body weights remained stable over the treatment period, going from 68.7 kg to 67.1 (p =0.83), without a marked cachectic weight loss being seen; body fat likewise remained stable (29.8% at baseline versus 29.4 at Day 28, p=0.60). The BMI also remained stable, at 23.0 at baseline versus 23.4 at Day 28, p=0.12). These results suggest that weight stabilization and body composition stability is seen in the anorexic-cachectic cancer patients with drug treatment at 28 days. The Karnofsky performance status of the patients also remained stable, being 68.3 at baseline and 67.2 at Day 28 (p=0.75).

In the subgroup of patients who chose to continue the trial for the extension period of additional 28 days, the mean body weight was 75.21 kg at baseline, 73.90 kg at Day 28 (p relative to baseline = 0.816), and 73.75 kg at study end (p relative to baseline=0.79), once again suggesting weight stabilization in these cachectic cancer patients. In the subgroup of patients who completed the full 56 days of treatment in Phase A and B, the Mean PGSA score improved from a value of 10.5 at baseline to a score of 6.1 at Day 56 (p=0.05).

The study investigators concluded that the drug treatment in Stage III/Stage IV cachectic cancer patients resulted in stabilization of body weight, BMI, body fat and Karnofsky scores. No rapid decline over time was observed even in patients who continued to Phase B and completed the extended 56 days of treatment. Such stabilization was seen despite 8 of 18 patients still receiving chemotherapy or radiation treatment. Statistically significant improvement was seen in ESAS appetite and PG-SGA scores and stability was seen in the Simmonds Functional assessment scores.

The drug product was well-tolerated by patients, with only mild transient pain or discomfort at the injection site being reported.

The results of this study have been reported in the medical literature: (M Chasen, et al., J. Am. Med. Dir. Assoc., 2011, 12:62-67.) and M. Chasen, et al., J. Cachexia Sarcopenia Muscle, 2013, 4:335. The trial results were sufficient to advance the product candidate to a subsequent clinical trial for the indication being evaluated.

Current Clinical Trial in Brazil in Hospitalized COVID-19 Patients

We have contracted with a contracting manufacturing company, Pace Laboratories, to manufacture EOM613 for clinical trial use. An entirely scalable manufacturing process has been developed. The drug product’s manufacture is fully compliant with the FDA’s currently mandated good manufacturing practices (cGMP) regulations and meets all current and stringent specifications for a sterile injectable drug product. This product has now been advanced for use in our Phase 1/2a Brazilian clinical trial in COVID-19 patients. The current open-label trial for COVID-19 in Brazil for EOM613 meets the regulatory Phase 1/2a clinical trial requirements of the Comissao Nacional de Etica em Pesquisa and the Brazilian regulatory body ANVISA. However, additional, larger Phase 2 placebo-controlled trials will be required for the further clinical development of EOM613 in the United States.

We believe EOM613 is an appropriate therapeutic for the treatment of hospitalized COVID-19 patients. The major cause of mortality in COVID-19 patients is linked to the runaway and prolonged hyperimmune reaction that occurs in certain COVID-19 patients, caused by an indiscriminate release of damaging cytokines and chemokines within the body, leading to the irreversible damage and destruction of lung tissue. An immunomodulator drug product that can dampen this aberrant immune response, while not concomitantly opening up the patients to secondary bacterial or fungal infections by over-suppression of the body’s overall immune responses, would be valuable in this clinical indication.

In August 2021, we enrolled our first patient in a 40-patient Phase 1/2a clinical trial for seriously ill COVID-19 patients in Brazil. The clinical trial is currently in progress at five clinical sites across Brazil, and is approved by the Comissao Nacional de Etica em Pesquisa national body in Brazil that reviews and approves clinical trials. The clinical trial is still enrolling patients and is currently in progress; clinical data on the study results will be released when available.

There are two cohorts being studied in the clinical trial; COVID-19 confirmed patients who are admitted into an ICU setting with the need of mechanical assisted ventilation and less gravely ill patients who are in need of hospitalization and supplemental oxygen, but are being treated outside the ICU setting. The drug product safety and efficacy are being evaluated over a 28-day study period in these patients. Additional details of this Brazilian clinical trial may be found on the ClinicalTrials.gov site:

https://clinicaltrials.gov/ct2/show/NCT05212532?term=EOM+Pharmaceuticals&cond=COVID-19&draw=2&rank=1

Initial results obtained on blood samples of the COVID-19 patients enrolled in the study and drawn at specific time-points after study initiation appear to validate the postulated mechanism of action of the drug as being able to modulate the action of various clinically relevant cytokines and chemokines in the patients, concomitant with their symptom resolution.

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Upon successful completion of this Phase 1/2a clinical trial in Brazil, it is projected that we would use the scientific data gathered from the trial to formulate a U.S. FDA approved clinical trial protocol for Cancer Cachexia and/or Rheumatoid Arthritis in the first quarter, 2023.

Cancer Cachexia Clinical Program

We intend to advance the clinical program to further evaluate the use of EOM613 in the treatment of cachexia in advanced cancer patients. Cancer cachexia, or the debilitating muscle wasting syndrome is prevalent in up to 50-80% of all cancer patients particularly those with solid tumors. (S. von Haehling and S.D. Anker, Prevalence, incidence and clinical impact of cancer cachexia; facts and numbers, Journal of Cachexia, Sarcopenia and Muscle, 2014, 5:261-263). There is currently no FDA- approved drug treatment for cancer cachexia, although the clinical need is very great. Initial promising results of the open label cancer cachexia trials conducted in the US and Canada have indicated promise in the use of daily subcutaneous injections of EOM613, which were well tolerated in patients.

We are initiating additional preclinical testing of the drug in recently established animal models of cancer cachexia as well as conduct ancillary animal tests including dose-ranging studies in order to establish optimal dosing of the drug product for the treatment of cancer cachexia. Various animal models of human cancer cachexia are now available, wherein an induced tumor in mice can cause weight loss and marked muscle wasting very similar to that seen in human cancer cachexia. An experimental drug’s effects on mitigating the symptoms of cancer cachexia in a dose-dependent fashion may therefore be studied using such animal models. The effects of the drug on the cytokine levels produced in the cachectic mice can also be followed in this animal model of cachexia through the disease course, providing additional insights on EOM613’s mechanisms of action. We are also initiating IND-enabling animal toxicology studies using subcutaneously administered EOM613 at different doses over a 56-day period in two animal species. Cancer cachexia requires a long-term ongoing treatment, as the FDA requires such long-term data in its IND review. Upon successful completion of these preclinical toxicity studies, projected to be completed by 4Q 2022, and if the animal model studies warrant, we intend to commence a placebo-controlled larger multi-center Phase 2 clinical trial in cancer cachexia patients in the USA under an IND.

Rheumatoid Arthritis Clinical Program

We intend to extend the use of EOM613 for the treatment of rheumatoid arthritis as well, based on the results of the pilot study in rheumatoid arthritis (RA) referenced above. We will seek to initially conduct a preliminary investigator-initiated trial with leading rheumatologists in patients who have failed other treatments such as with disease modifying agents such as methotrexate. On the basis of the results of such an investigator-sponsored trial, should the results warrant it, we would seek to initiate a Phase 2 placebo-controlled trial in a wider cohort of similarly afflicted patients. As with the cancer cachexia IND review mentioned above, the FDA will be looking for the longer-term animal toxicology data to be available in the IND, and the 56-day multidose toxicology data being generated in two species will serve the purpose for the RA clinical application as well. There are also established animal models of RA available at preclinical CROs, typically conducted in rats and in mice, and we are initiating those studies to support an IND in this therapeutic area. The collagen-induced arthritis (CIA) model is most frequently employed, together with a mouse knee arthritis model; these simulate the symptomology of human RA to a large degree. These animal models also allow for blood cytokine levels to be measured during the course of the study, allowing for correlations with cytokine levels typically also found in human RA disease, and studying any mitigation of symptoms provided by EOM613.

Competitive Landscape for EOM613

In the treatment of COVID-19, the main immunomodulator drugs that are being used experimentally to counteract the hyperimmune effects in patients consist of corticosteroids, Interleukin-6 inhibitors such as tocilizumab or sarilumab or Janus kinase (JAK) inhibitors such as baricitinib and tofacinitib.

For the treatment of rheumatoid arthritis, the mainstays of therapy remain the corticosteroid drugs, and for severe arthritis the use of string disease modifying drugs such as methotrexate. Among newer biologicals are monoclonal antibody drugs that are TNF-alpha antagonists, which target one specific cytokine that is responsible for the pathology of rheumatoid arthritis. TNF inhibitors include drugs such as Certolizumab (Cimzia), Adalimumab (Humira) and Infliimab (Remicade), and Interleukin-6 (IL-6) blockers, such as Tocilizumab (Actmera) or Sarilumab (Kevzara). Another antibody drug that targets the CD20 antigen is Rituximab (Rituxan). These are administered by intravenous infusion or bi-monthly injections; in comparison, EOM613 is given by subcutaneous injection, similar to an insulin shot self-administered by patients. Rheumatoid arthritis afflicts over 13 million persons in the United States alone, with over 200,000 new patients being diagnosed each year. (TM Hunter, et al., Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, Rheumatol. Int., 2017; 37:1551).

There are currently no FDA-approved treatments for the treatment or mitigation of cancer cachexia. Worldwide, there has been one approval for an anti-cachexia drug, the ghrelin receptor agonist, anamorelin (Adlumiz), which was approved in Japan in December 2020. Worldwide, cancer cachexia afflicts 50-80% of all cancer patients and remains a leading cause of mortality and extremely poor quality of life in patients with advanced cancers.

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SQUALAMINE LACTATE OPHTHALMIC SOLUTION

Squalamine Lactate Ophthalmic Solution

Squalamine lactate is a small molecule anti-angiogenic drug with a novel intracellular mechanism of action. The drug acts against the development of aberrant neovascularization by inhibiting multiple protein growth factors of angiogenesis, including vascular endothelial growth factor (“VEGF”), platelet-derived growth factor (“PDGF”) and basic fibroblast growth factor (“bFGF”). Recent clinical evidence has shown PDGF to be an additional target for the treatment of wet-AMD and bFGF levels have been shown to be elevated in retinal vein occlusion and wet-AMD patients.

Squalamine is a novel molecule in being able to modulate the action of all three of these growth factors of angiogenesis. Angiogenesis, the process of new leaky blood vessels forming within the retina, concomitant with the elevation of the aforementioned growth factors is the hallmark of various sight-compromising retinal diseases such as the wet form of age-related macular degeneration (wet-AMD), proliferative and non-proliferative diabetic retinopathy, retinal vein occlusions, including central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), retinopathy of premature that affects “preemies”, and also other ocular non-retinal ocular conditions such as neovascular glaucoma and corneal neovascularization secondary to infections or inflammatory processes. The Squalamine eyedrop formulation has the potential for treating all these conditions.

Squalamine appears to have a novel and distinct anti-angiogenic effect in mammalian cells by binding to calmodulin in the cell membrane once it is taken up by the cell; since VEGF, PDGF and bFGF all rely on calmodulin in the cell for their actions. Once squalamine binds to calmodulin in activated endothelial cells, the complex of the two is chaperoned into the cell’s interior and away from the cell membrane. This in turn then prevents signal transduction downstream of all these growth factors involved in the neovascularization in retinal diseases, including VEGF, PDGF and bFGF, which all need calmodulin in the cell membrane to bind to (B. Connolly et al., Ophthalmol. Clin. North Am., 2006, 19: 381-391). No other molecule has been reported or known to produce such an effect on multiple growth factors of angiogenesis. The current conventional drugs that are approved to treat angiogenic retinal diseases are biological antibody drugs, largely targeted against VEGF.

Source: I. Taraporewala, et. al. A Novel Eye Drop Formulation of Squalamine for Exudative AMD: Evaluation of Ocular Distribution and Ocular Safety in Rabbits, et al., Investigative Ophthalmology & Visual Science, 2012, 53:457.

Squalamine lactate was formulated as a topical solution for ophthalmic indications and optimized the formulation for enhanced uptake into the back of the eye, and to potentially provide increased comfort in an elderly patient population. The Company intends to advance its clinical wet-AMD program, and also establish programs in diabetic retinopathy and retinal vein occlusions with its enhanced novel topical formulation. Unlike other combination therapy approaches being evaluated in clinical studies, Squalamine does not require direct injection into the eye, as do current treatments for sight-robbing retinal diseases.

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We believe that Squalamine used alone or in combination with an anti-VEGF agent may provide several potential advantages over other combination therapy approaches currently being investigated in clinical studies including:

● Daily topical therapy compared to additional monthly intravitreal injections, similar to a daily eyedrop application for treatment of glaucoma. Have great potential in treating sight-robbing retinal diseases in nations where the expensive intravitreal injections given directly into the eye and administered by highly trained retinal physicians, are not commonly available to the populace

● Potential use in combination with as-needed (PRN) anti-VEGF injections or treat-and-extend regimens as well as a monthly/bi-monthly anti-VEGF injection regimens.

● Adaptable for use in combination with future longer acting anti-VEGF agents.

● Inhibition of multiple biochemical growth factor pathways of angiogenesis.

● Cost efficiency of manufacturing a small molecule when compared to large molecule proteins and antibodies.

We will be conducting additional pharmacokinetic and toxicology studies to support the clinical development of the novel enhanced formulation of Squalamine Lactate, name EOM147 Topical Solution. This will involve the toxicological testing the new formulation in rabbit eyes over a period of 28 days or more, and pharmacokinetic studies measuring the uptake of the squalamine in the ocular tissues of rabbits, including retinal uptake, upon dosing over a 28-day period. These animal studies are to be outsourced, contracted to and conducted by an FDA-registered clinical research organization laboratory; planned for the first quarter in 2023 when GLP supplies of the novel formulations are available.

We have also contracted with a Contract Manufacturing Organization (CMO) Eurofins Alphora, to develop a new scalable industrial methodology for the scaled-up GMP production of Squalamine Lactate active pharmaceutical ingredient.

Ophthalmic Clinical Trials with Squalamine Lactate

Completed Phase 2 Trial in wet-AMD: the IMPACT Study

The IMPACT Study, a multicenter study conducted in the United States by OHR Pharmaceutical, Inc, which began enrolling patients in late 2012 and whose results were reported in 2015, was a multi-center, randomized, double masked, placebo-controlled Phase 2 study to evaluate the efficacy and safety of Squalamine combination therapy for the treatment of wet-AMD. The study enrolled treatment naïve wet-AMD patients at more than 20 clinical sites, who were randomly assigned to treatment with Squalamine lactate ophthalmic solution 0.2% (“Squalamine”), or placebo eye drops administered twice daily for a nine-month period, along with Lucentis® injections, as necessary, following an initial baseline Lucentis® injection. Full enrollment was completed in April 2014. In March 2015, OHR Pharmaceuticals Inc. completed the IMPACT Study and announced the topline results. The final data from the IMPACT Study was presented at multiple scientific conferences and forums in 2015 and 2016. In a prespecified analysis, data from the IMPACT study demonstrated that, in the intent-to-treat (ITT-LOCF) population with lesions containing classic choroidal neovascularization (“classic CNV”) (Squalamine combination treatment n=38, Lucentis® monotherapy n=32), 42% of the patients receiving Squalamine achieved a ≥3-line gain at nine months, as compared to 28% in the Lucentis® monotherapy group. In patients with classic CNV (ITT-LOCF), mean gains in visual acuity were +10.5 letters for the Squalamine combination arm and +5.4 letters with Lucentis® monotherapy, a clinically meaningful benefit of +5.1 letters. The positive effect on visual acuity in classic CNV was seen early in the course of treatment and continued to increase through the end of the study. Less of a visual acuity benefit was seen in the overall population (all AMD lesion types). The mean number of injections between the treatment arms, the primary endpoint of the study, was not meaningfully different.

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Further analyses were conducted to determine the patient population most likely to benefit from combination treatment. Patients with lesions containing classic CNV are a heterogeneous population and, within the enrollment criteria of our study, could have encompassed small classic lesions with no occult component as well as lesions up to 12 disc areas (~30mm²) in size made up almost entirely of occult CNV. These diverse lesions would both fall under the same category of “classic containing lesion” even though they would be expected to respond differently to treatment. Correlation analyses determined that the occult CNV size at baseline, regardless of whether there was a classic CNV component present, directly correlated with improved visual acuity outcomes in the Squalamine combination group (p=<0.0001), which was not seen in the Lucentis® monotherapy group. This suggests that the occult CNV size was a more important predictor of success for combination therapy than the presence of classic CNV, and a cutoff less than 10mm² of occult size at baseline was determined to be the optimal size to include in future clinical studies. In those patients with occult CNV less than 10mm² in area (n=94 of 128 completing the phase 2 study), 40% of those treated with Squalamine combination therapy achieved a gain of 3 or more lines of vision, compared with 26% of patients in the Lucentis® monotherapy arm, a 54% additional benefit. In addition, mean gains in visual acuity compared to baseline were +11.0 letters for the Squalamine combination arm and +5.7 letters with Lucentis® monotherapy, a clinically meaningful benefit of +5.3 letters (exploratory p-value, p=.033). Importantly, this group of patients represents a larger proportion of the subjects enrolled in the IMPACT study than the classic lesion containing group. The ITT data in patients with the classic variety of AMD lesions also showed a more pronounced separation between the Squalamine eyedrop treated group and the Lucentis monotherapy group for those patients who achieved a >4 and >5 line gain in vision. Of the patients who received the eye drop, 22% achieved a 4 line or better vision gain on the eye chart and 14% achieved 5 line or better vision gains as compared to 7% of patients with a 4 line or better gain and 7% with a 5 line or better gain for those in the Lucentis monotherapy arm. The results of the IMPAT trial showed that topically administered squalamine lactate drops led to improved visual function in patients with wet AMD compared to treatment with PRN Lucentis. The eye drops were very well tolerated by patients in the study.

AKO trial- Study 002

The Phase 3 program was conducted at 118 clinical sites in the US, between 2016-2018, in order to evaluate the efficacy and safety of Squalamine given in combination with Lucentis® for treatment in naive patients with wet-AMD. The comprehensive clinical program comprised of double-masked, placebo-controlled, multicenter, international study of Squalamine administered twice a day in patients with newly diagnosed wet AMD, in combination with monthly Lucentis® injections. The primary endpoint was to be a measurement of visual acuity gains at nine months, with patients followed to two years for safety. Patients received Squalamine or placebo eye drops twice a day and received Lucentis® during their monthly monitoring visits. This trial, conducted by OHR Pharmaceutical Inc., the former company that developed the drug product, failed to meet its primary endpoints of visual acuity gains. Eligibility criteria for the study eye included: newly diagnosed with wet-AMD and no previous treatment, occult type neovascularization, if present, measuring <10 mm squared as assessed by fluorescein angiography and visual acuity between 20/40 and 20/30. The key difference between this study design and the earlier IMPACT trial was that this MAKO trial incorporated a mandatory monthly rescue injection of Lucentis. A total of 237 subjects were randomized. Subjects were randomized 1:1 to receive topical Squalamine lactate ophthalmic solution, 0.2%, twice daily and monthly Lucentis intravitreal injections were also administered. Visual acuity was measured during the monthly study visits using the ETDRS eye chart. The primary designated endpoint was the visual acuity at 9 months, using a mixed effects model for repeated measures (MMRM) analysis. The study had been statistically powered for an enrollment of 600 patients but was terminated and analyzed at only a 237 patient total enrollment due to slow recruitment due to many competing wet AMD trials also being conducted at the time. The study also did not have a monotherapy arm in order to be able to demonstrate the efficacy of Squalamine eye drops in the absence of the intravitreal; injection of Lucentis. At the time the FDA had required a standard of care + experimental drug treatment regimen to be conducted rather than allow a monotherapy trial to be conducted; since that time other company trials have now been permitted with a monotherapy treatment arm for wet-AMD drug trials. Company trials have now been permitted with a monotherapy treatment arm for wet-AMD drug trials.

Trial in Proliferative Diabetic Retinopathy (“PDR”) - Study 003

Study 003 was an open-label monotherapy investigator sponsored trial (“IST”) evaluating Squalamine in five patients with PDR. Patients enrolled in the study, who were newly diagnosed with PDR and received no prior treatments for the condition received Squalamine for a six-month treatment period and were then followed for an additional two months. The endpoints included regression of neovascularization, anatomical measurements, visual acuity, and safety parameters. The principal investigator of Study 003 presented a case report from the first patient to complete the protocol at the 37th Annual Macula Society meeting. In this case report, the oral presentation discussed the case of the treatment naïve patient diagnosed with PDR. The data demonstrated that topical application of Squalamine in a monotherapy regimen, twice daily and then four times daily, was associated with regression of retinal neovascularization within a period of two months. The retinal neovascularization remained regressed throughout the six months of four times daily Squalamine therapy. One month after cessation of treatment, the abnormal blood vessels returned in this patient’s retina in the absence of Squalamine treatment, and continued to grow through the second month, the latest time point measured. The clinical investigator concluded that the regression of the vision threatening blood vessels while the patient was on topical Squalamine monotherapy treatment, coupled with the return and worsening of the neovascularization once Squalamine was withdrawn, supports further studies of a therapeutic treatment of PDR using Squalamine eye drops.

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Completed Trial in Branch and Central Retinal Vein Occlusion -Study 004

Study 004 was an IST evaluating Squalamine lactate ophthalmic solution, 0.2%, in 20 patients with branch and central retinal vein occlusion. All patients in the study received Squalamine for 10 weeks, with injections of Lucentis® at weeks two and six, and a data readout at week 10. At week 10, the patients entered into the extension phase and were randomized 1:1 to either continue or discontinue taking Squalamine through week 38 (“extension phase”). During the extension phase, the patients received Lucentis® injections on a PRN basis as determined by fluid-based OCT criteria. The principal investigator presented the 10-week data from the study. The data demonstrated that, at week 10 (1) the mean gain in visual acuity was 20.3 letters for all 20 patients using the combination therapy, (2) the mean visual acuity for all 20 patients at was 20/32, (3) the average central foveal thickness for all 20 patients was reduced to 270u, and (4) only one of 20 patients qualified for an injection of Lucentis®, indicating dryness of the retina and a 95% macular deturgescence (macular dryness) rate.

In July 2015, final data was presented demonstrating that at week 38, (1) the mean gain in visual acuity from baseline for patients randomized (at week 10) to treatment with Squalamine + Lucentis® PRN was +27.8 letters compared with +23.3 for patients randomized to treatment with Lucentis® plus PRN alone (control group), a clinically meaningful difference of +4.5 letters, (2) 80% of patients in the Squalamine + Lucentis® treated group had a gain in visual acuity, compared with 50% of patients treated with Lucentis® alone, and (3) none of the patients in the Squalamine + Lucentis® treated group lost any vision as compared to 50% of the patients receiving Lucentis® alone. After the initial combination therapy phase, the mean gain in visual acuity from week 10 to week 38 was +7.4 letters for patients who continued treatment with Squalamine + Lucentis® PRN compared with +3.1 letters in those receiving Lucentis® PRN alone. The study was published by the principal investigator in a medical journal publication (J.J. Wroblewski, et al., Ophthalmic Surg. Lasers Imaging Retina, 2016; 914-923).

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Clinical Trial Path Forward with EOM147

Once the animal toxicology studies and data are available for the ocular toxicity of the new enhanced formulation of Squalamine lactate, EOM147, and we can show that is well tolerated, by the second or third quarter of 2023, we intend to conduct initial Phase 2 clinical trials for safety/efficacy.

In wet-AMD we plan on initially conducting an ex-US trial in wet-AMD, in nations such as India or Mexico where the intravitreal injections of anti-VEGF biologicals are not commonly available or are priced way out of range of most patients with wet-AMD. We will plan a similar ex-US clinical trial in proliferative diabetic retinopathy as well.

For the treatment of the macular edema associated with proliferative diabetic retinopathy (PDR) we also intend to conduct a wider Phase 2 monotherapy clinical trial as an investigator sponsored trial (IST) in the United States, during the third quarter of 2023 based on the initial results obtained in this condition.

For the treatment of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), we will similarly plan to conduct a monotherapy trial with EOM147 trial in the US as an investigator- IST at a handful of clinical sites.

We also intend to look into the possibility of conducting a trial to treat the retinopathy of prematurity, a sight-robbing disorder in some premature infants under an IST. The use of eye drops to treat this condition is especially favorable since it is difficult and hazardous to give intravitreal injections directly into the eyes of neonates. This condition would also qualify as an “orphan” indication, based on the incidence of this disorder in the United States.

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Competition

Competition in the area of biomedical and pharmaceutical research and development is intense and significantly depends on scientific and technological factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain regulatory approval for testing, manufacturing and marketing. Our competitors include major pharmaceutical and specialized biotechnology companies, many of which have financial, technical and marketing resources significantly greater than ours. In addition, many biotechnology companies have formed collaborations with large, established companies to support research, development and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures. We are aware of certain other products manufactured or under development by competitors that are used for the treatment of the health conditions that we have targeted for product development. We can provide no assurance that developments by others will not render our technology obsolete or noncompetitive, that we will be able to keep pace with new technological developments or that our technology will be able to supplant established products and methodologies in the therapeutic areas that are targeted by us. The foregoing factors could have a material adverse effect on our business, prospects, financial condition and results of operations. These companies, as well as academic institutions, governmental agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants.

Competition within our sector is increasing, so we will encounter competition from existing firms that offer competitive solutions in ocular diseases. These competitive companies could develop products that are superior to, or have greater market acceptance, than the products being developed by us. We will have to compete against other biotechnology and pharmaceutical companies with greater market recognition and greater financial, marketing and other resources. In the cancer cachexia space, Acacia Pharmaceuticals has a drug candidate, APD209, currently under clinical evaluation. Endevica Bio (Formerly TCI Peptide Therapeutics) also has a drug candidate, TCMCB07, under clinical investigation in cancer cachexia. The multinational pharmaceutical company, Pfizer is developing a biological drug, a monoclonal antibody directed against the Growth Differentiation Factor protein, PF-06946860 as an anti-cachexia drug candidate. The drug anamorelin was approved for the treatment of cancer cachexia in Japan in December 2020. This ghrelin receptor agonist small molecule drug may receive regulatory approval and be marketed in the future in other nations.

In the rheumatoid arthritis treatment space, several companies have pipeline new drug candidates under development, such as Novartis (ACZ885 monoclonal antibody against IL-1 beta), Bristol Myers Squibb (deucravacitinib, JAK kinase inhibitor) Gilead Sciences (filgotinib small molecule drug), AbbVie (ABBV-154, anti-TNF-alpha biological drug), JAK-kinase inhibitor, Sorrento Therapeutics (Resiniferatoxin), Taisho Pharmaceuticals (TS-1520), Ablynx (ATN-103, anti-TNF-alpha monoclonal antibody). Most of the current focus in RA has been in the development of biologicals, mainly directed at one cytokine or the development of Janus Kinase inhibitors (JAK inhibitors).

Wet-AMD

The current FDA approved market leaders for the treatment of wet AMD are VEGF inhibitors, including Ramizibumab (Lucentis®), Aflibercept (Eylea®), Brolucizumab (Beovu®) and (off-label) Bevacizumab (Avastin®). In 2020, annual revenue (worldwide) was more than $3.5 billion for Lucentis®, despite significant off-label use of Avastin® (estimated to be 45-60% of the overall market). Eylea®, is approved for use in wet-AMD and other retinal indications and achieved 2020 revenues of approximately $8.36 billion. Beovu, which was approved by the FDA and introduced more recently, in 2019, achieved 2020 sales of $190 million. Lucentis® and Eylea® are administered via frequent intravitreal injections directly into the eye. We are developing Squalamine for use as a convenient to administer a non-invasive eyedrop as monotherapy and as well as in combination with Lucentis® and other anti-VEGF agents to improve visual function beyond that achieved with anti-VEGF therapy alone.

A competing eye drop formulation, also currently in clinical development is Panoptica’s investigational drug, PAN-90806, a once-daily suspension formulation eyedrop that targets VEGF. Topline results of a Phase1/2 dose-ranging clinical trial as a monotherapy over just 8 weeks’ treatment showed safety and suggested biological activity in 20 treatment-naïve patients newly diagnosed with wet AMD with PAN-90806. The Panoptica drug is a selective VEGF blocker, that inhibits the VEGF cell receptor’s tyrosine kinase activity. As a differentiator, EOM147 blocks all the three angiogenic growth factors known to be responsible for retinal angiogenesis, including VEGF, PDGF and bFGF. by blocking calmodulin-mediated cell signaling across the board, and therefore addresses all three of these biochemical targets in wet AMD treatment simultaneously with a single drug molecule.

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Diabetic Retinopathy

Diabetic retinopathies, which currently affect an estimated 200 million persons worldwide, are currently treated with laser treatments, steroid treatments injected into the eye, and when there is blood vessel growth and retinal bleeding or macular edema present, by intravitreal injections into the eye of the same anti-VEGF drug products that are currently available to treat wet-AMD. In terms of experimental drug products being evaluated, the Panoptica drug candidate, PAN-90806, being evaluated in wet-AMD is also being evaluated in a trial in diabetic macular edema (DME). Verseon has an oral drug candidate, VE-4840, targeting DME as well. This drug has an alternate biochemical mechanism of action, being a plasma kallikrein inhibitor. Ocuterra also has a topical eye drop of a small molecule integrin inhibitor drug under development for the treatment of macular edema related to diabetic retinopathy that is slated to commence a Phase I/II clinical trials in 2022.

Retinal Vein Occlusions

The macular edema in retinal vein occlusions (RVOs) is currently treated with intravitreal injections of anti-VEGF drugs directly into the eye or with the use of intravitreally injected steroids. In refractory cases, the BRVO sub-type is sometimes treated with laser photocoagulation treatment as well. This involves creating a localized area of scar tissue that may seal off a retinal tear or leaking blood vessels. The procedure does permanently scar the localized area of the area of the retina and is therefore not an ideal treatment. A non-invasive, non-injected therapy for the treatment of RVOs such as would therefore be ideal. In addition to EOM147, the Panoptica drug candidate PAN-90806 as eye drops is also slated for clinical trials in RVO. PAN-90806 acts via a very different mechanism of action from EOM147’s.

Intellectual Property

Our success depends, in part, on our ability to obtain, maintain, and enforce patents and other proprietary protections of our commercially important technologies and product candidates, to operate without infringing the proprietary rights of others, and to maintain trade secrets or other proprietary know-how, both in the U.S. and other countries. Our ability to stop third parties from making, using, selling, offering to sell or importing our products will depend on the extent to which we have rights under valid and enforceable patents or trade secrets that protect these activities. We seek to protect proprietary technology, inventions, and improvements that are commercially important to our business by seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties.

We do not currently own any patents. Our technology is largely based on expired patents. However, we expect to file for patent protection on a novel method of manufacture of the squalamine lactate drug substance to provide scalable industrial quantities of the material. In addition, patent applications may be made for the composition of novel ophthalmic formulations of squalamine lactate. For EOM613, new intellectual property may be obtained on the drug’s specific effects on cytokine receptor modulation and on the drug product’s use in additional clinical indications of interest.

On October 20, 2021, we filed a US and a provisional international PCT patent applications under the title: “EOM613 for Treatment of Covid-19.” The patent relates specifically to the use of EOM613 to treat SARS-CoV-2 infections. It does not cover the compound itself or the process of making it.

Material Agreements

Pace Analytical, Inc.

In May 2020, EOM entered into a Service and Quality Agreement with Bio Concept Laboratories, Inc. (“Pace”) now known as Pace Analytical Inc. pursuant to which Pace is to provide for a three-year term, research, drug development and laboratory consulting and scientific services. The agreement also calls for Pace to perform certain product testing and manufacturing processes necessary to develop and produce usable clinical trial samples. The total project cost for the various services to be provided amount to $803,225.

Communications and R&D Services Agreement

Effective September 4, 2020 as amended on December 1, 2020, EOM entered into a Communications Services Agreement (the Services Agreement) with GMJ Global LLC dba TogoRun, LLC (“TOGO”) a full-service healthcare consultancy company providing senior expertise in pharmaceutical clinical development, R&D planning, regulatory affairs, scientific communications and advisory board development, commercial strategy and execution, and corporate communications across all media.

Azidus Agreement

In March 2021, EOM entered into a Master Services Agreement with Azidus, a Brazilian based Contract Research Organization (the “Azidus Agreement”) to serve as our clinical trial operator in Brazil in connection with our EOM613 COVID-19 open label investigatory clinical trial. We have the right to terminate the Azidus Agreement for convenience or other reasons specified in the Azidus Agreement upon prior written notice with no termination fee. Effective July 19, 2021 the Azidus Master Service Agreement was amended to reflect additional clinical trial protocol procedures. The Azidus Agreement is estimated to cost approximately $1,092,000.

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Eurofins CDMO Alphora Inc. Agreement

On December 14, 2021, we entered into a Squalamine Lactate Route Selection, Development and Demonstration Agreement with Eurofins CDMO Alphora, Inc., a Canadian based Contract Research Organization to evaluate various synthetic routes to access Squalamine Lactate for purposes of further research and development of our EOM147 drug compound. The agreement is structured under a Phase 1 and Phase 2 work plan spanning over a ten-month period. The estimated aggregate cost under the agreement is approximately $1,300,000.

Charles River Laboratories Montreal LLC

On April 18, 2022, we entered into an agreement with Charles River Laboratories Montreal, LLC to conduct a comprehensive multi-animal toxicity study to assess the impact of our new Squalamine formulation on intraocular eyedrop administration. The study is not expected to commence until fourth quarter 2022 or first quarter 2023 depending on Charles River’s scheduling availability. The total cost of the study approximates $1.3 million. Our financial obligations will not commence until the study begins. Certain cancellation fees will apply depending on the timing of our cancellation notice and the delivery of the animals.

Government Regulation

Government authorities in the United States at the federal, state and local level, including the FDA, the FTC and the DEA, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution, marketing and export and import of products such as those we market. For both currently marketed and future products, failure to comply with applicable regulatory requirements can, among other things, result in suspension of regulatory approval and possible civil and criminal sanctions. Regulations, enforcement positions, statutes and legal interpretations applicable to the pharmaceutical industry are constantly evolving and are not always clear. Significant changes in regulations, enforcement positions, statutes and legal interpretations could have a material adverse effect on our financial condition and results of operations.

Additionally, future healthcare legislation or other legislative proposals at the federal and state levels could bring about major changes in the affected health care systems, including statutory restrictions on the means that can be employed by brand and generic pharmaceutical companies to settle Paragraph IV patent litigations. We cannot predict the outcome of such initiatives, but such initiatives, if passed, could result in significant costs to us in terms of costs of compliance and penalties associated with failure to comply.

Pharmaceutical Regulation in the United States

In the United States, the FDA regulates drugs under the FDCA and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, Warning Letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

FDA approval is required before any new unapproved drug or dosage form, including a new use of a previously approved drug or a generic version of a previously approved drug, can be marketed in the United States.

The process required by the FDA before a new drug may be marketed in the United States generally involves:

● Completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s current GLP regulations;

● Submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin in the United States;

● Approval by an IRB at each clinical site before each trial may be initiated;

● Performance of adequate and well-controlled human clinical trials in accordance with the FDA to establish the safety and efficacy of the proposed drug product for each intended use;

● Satisfactory completion of an FDA pre-approval inspection of the facility or facilities at which the product is manufactured to assess compliance with the FDA’s cGMP regulations to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

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● Submission to the FDA of an NDA;

● Satisfactory completion of a potential review by an FDA advisory committee, if applicable; and

● FDA review and approval of the NDA.

Preclinical Studies

When developing a branded product and bringing it to market, the first step in proceeding to clinical studies is preclinical testing. Preclinical tests are intended to provide a laboratory or animal study evaluation of the product to determine its chemistry, formulation and stability. Toxicology studies are also performed to assess the potential safety of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including GLPs. The results of these studies are submitted to the FDA as part of an IND application along with other information, including information about product chemistry, manufacturing and controls and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.

Clinical Trials

Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it initiates at that institution. Information about certain clinical trials must be submitted within specific timeframes to the NIH for public dissemination on their website, www.ClinicalTrials.gov.

Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:

● Phase I: The drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness.

● Phase II: The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.

● Phase III: The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product.

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2, and Phase 3 trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

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Disclosure of Clinical Trial Information

Sponsors of certain clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information on www.ClinicalTrials.gov. Information related to the product, subject population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss certain results of their clinical trials after completion. Disclosure of the results of these trials can be delayed until the new product or new indication being studied has been approved. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

Marketing Approval

After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States. The NDA must include, among other things, the results of all preclinical, clinical and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls. Under federal law, the submission of most NDAs is subject to a substantial application user fee, and the manufacturer or sponsor under an approved NDA is also subject to annual program fees. The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information and is subject to payment of additional user fees. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. Under the Prescription Drug User Fee Act, as amended, the FDA has agreed to certain performance goals in the review of NDAs through a two-tiered classification system, Standard Review and Priority Review. Priority Review designation is given to drugs that are intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness over existing therapies. The FDA endeavors to review most applications subject to Standard Review within ten to twelve months whereas the FDA’s goal is to review most Priority Review applications within six to eight months, depending on whether the drug is a new molecular entity.

The FDA may refer applications for novel drug products or drug products which present difficult questions of safety or efficacy to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. Before approving an NDA, the FDA may inspect one or more clinical sites to assure compliance with GCP requirements. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the NDA unless it determines that the manufacturing process and facilities are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications and the NDA contains data that provide substantial evidence that the drug is safe and effective for the labeled indication.

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter to indicate that the application is not ready for approval. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA may ultimately decide that an application does not satisfy the regulatory criteria for approval. If, or when, the deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

As a condition of NDA approval, the FDA may require a REMS to help ensure that the benefits of the drug outweigh the potential risks. If the FDA determines a REMS is necessary during review of the application, the drug sponsor must agree to the REMS plan at the time of approval. A REMS may be required to include various elements, such as a medication guide or patient package insert, a communication plan to educate healthcare providers of the drug’s risks, limitations on who may prescribe or dispense the drug, or other elements to assure safe use, such as special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patient registries. In addition, the REMS must include a timetable to periodically assess the strategy. The requirement for a REMS can materially affect the potential market and profitability of a drug.

Moreover, as a condition of product approval, the FDA may require substantial post-approval testing, known as Phase IV testing, and/or surveillance to monitor the drug’s safety or efficacy, and the FDA has the authority to prevent or limit further marketing of a product based on the results of these post-marketing programs. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or certain problems are identified following initial marketing. Drugs may be marketed on