Delaware |
2834 |
27-2989408 | ||
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
Large accelerated filer |
☐ |
Accelerated filer |
☐ | |||
☒ |
Smaller reporting company |
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Emerging growth company |
PRELIMINARY PROSPECTUS |
Subject to Completion |
September 1, 2022 |
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F-1 |
(a) | at least a majority of the outstanding shares of Legacy Apexigen capital stock, voting together as a single class and |
(b) | at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock of Legacy Apexigen, voting together as a single class on an as-converted basis; |
• | Sotigalimab co-stimulatory receptor that is essential for activating both the innate and adaptive arms of the immune system, to stimulate an anti-tumor immune response. Sotigalimab is currently in Phase 2 clinical development for the treatment of solid tumors such as melanoma, esophageal and gastroesophageal junction (“GEJ”) cancers, sarcoma, and ovarian cancers in combination with immunotherapy, chemotherapy, radiation therapy and cancer vaccines. |
• | APX601 |
• | We are in the early stages of clinical drug development and have a limited operating history and no products approved for commercial sale. |
• | We have incurred net losses since inception and expects to continue to incur significant net losses for the foreseeable future. |
• | We will require substantial additional capital to finance operations. If we are unable to raise such capital when needed or on acceptable terms, we may be forced to delay, reduce, and/or eliminate one or more research and drug development programs or future commercialization efforts. |
• | We are dependent on the success of our product candidates, including our lead product candidate, sotigalimab, which is currently in multiple clinical trials . |
• | Our clinical trials may reveal serious adverse events, toxicities, or other side effects of our current and any future product candidates that result in a safety profile that could inhibit regulatory approval or market acceptance of our product candidates. |
• | If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary marketing approvals could be delayed or prevented. |
• | The clinical trials of our current and any of our future product candidates may not demonstrate safety and efficacy to the satisfaction of regulatory authorities or otherwise be timely conducted or produce positive results. |
• | The regulatory approval processes of the Food and Drug Administration, European Medicines Agency, and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will be substantially harmed. |
• | If we are unable to obtain, maintain, enforce, or protect our intellectual property rights in any products we develop or in our technology, if the scope of the intellectual property protection obtained is not sufficiently broad, or if we infringe the intellectual property rights of others, third parties could develop and commercialize products and technology similar or identical to those of Apexigen, we could be prevented from commercializing our products and we may not be able to compete effectively in our markets. |
Issuer |
Apexigen, Inc. |
Shares of Common Stock issuable upon exercise of Warrants |
3,724,500 shares of Common Stock (including (i) 2,875,000 shares issuable upon the exercise of the Public Warrants, (ii) 726,000 shares issuable upon the exercise of the PIPE Warrants, and (iii) 123,500 shares issuable upon the exercise of the Private Placement Warrants). |
Exercise Price of the Warrants |
$11.50 per share, subject to adjustment as described herein. |
Common Stock offered by the Selling Securityholders |
14,434,863 shares of Common Stock (including (i) 8,009,884 Business Combination Shares, (ii) 1,452,000 PIPE Shares, (iii) 1,248,479 Private Shares, (iv) 2,875,000 shares issuable upon the exercise of the Public Warrants, (v) 726,000 shares issuable upon the exercise of the PIPE Warrants, and (vi) 123,500 shares issuable upon the exercise of the Private Placement Warrants). |
Warrants offered by the Selling Securityholders |
849,500 warrants (including (i) 726,000 PIPE Warrants and (ii) 123,500 Private Placement Warrants). |
Redemption |
The Warrants are redeemable in certain circumstances. See the section of this prospectus titled “ Description of Securities |
Common Stock outstanding (as of July 29, 2022) |
21,445,035 |
Use of Proceeds |
We will not receive any proceeds from the sale of the Offered Shares and the Offered Warrants by the Selling Securityholders (the “Securities”). We will receive up to an aggregate of approximately $42.8 million from the exercise of all Warrants, assuming the exercise in full of such Warrants for cash. We expect to use the net proceeds from the exercise of the Warrants for general corporate purposes. We believe the likelihood that warrant holders will exercise their warrants, and therefore the amount of cash proceeds we would receive, is dependent upon the trading price of our Common Stock, the last reported sale for which was $4.37 per share on August 30, 2022. As the trading price of our Common Stock is less than the $11.50 exercise price per share of the warrants, we expect that warrant holders will not exercise their warrants. See the section titled “ Use of Proceeds |
Risk Factors |
See the section titled “ Risk Factors |
Nasdaq Symbol |
“APGN” for our Common Stock. |
“APGNW” for our Warrants. |
Lock-Up Restrictions |
Certain of our stockholders are subject to a lock-up agreement that restricts, subject to certain exceptions, transfer of shares of our Common Stock or other securities exercisable, exchangeable or convertible into shares of Common Stock. See the section titled “Description of Securities |
• | 3,415,868 shares of our Common Stock issuable upon the exercise of options assumed from Legacy Apexigen as a result of the Business Combination, with a weighted-average exercise price of $3.15 per share; |
• | 3,724,500 shares of our Common Stock issuable upon the exercise of warrants, each with an exercise price of $11.50 per share; |
• | 4,321 shares of our Common Stock issuable upon the exercise of a warrant assumed from Legacy Apexigen as a result of the Business Combination with an exercise price of $1.55 per share; |
• | 2,573,405 shares of our Common Stock reserved for future issuance under our 2022 Equity Incentive Plan (the “2022 Plan”); |
• | 257,341 shares of our Common Stock reserved for future issuance under our 2022 Employee Stock Purchase Plan (the “2022 ESPP”) and |
• | any additional shares that we may issue to Lincoln Park pursuant to the Lincoln Park Purchase Agreement should we elect to sell such shares to Lincoln Park. |
• | no exercise of outstanding options or warrants subsequent to July 29, 2022. |
• | successful and timely completion of preclinical and clinical development of current and any future product candidates; |
• | timely receipt of marketing approvals from applicable regulatory authorities for current and any future product candidates for which we successfully complete clinical development; |
• | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |
• | developing an efficient and scalable manufacturing process for current and any future product candidates, including establishing and maintaining commercially viable supply and manufacturing relationships with third parties to obtain finished products that are appropriately packaged for sale; |
• | successful launch of commercial sales following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more partners or collaborators; |
• | a continued acceptable safety profile following any marketing approval; |
• | commercial acceptance of current and any future product candidates as viable treatment options by patients, the medical community, and third-party payors; |
• | addressing any competing technological and market developments; |
• | identifying, assessing, acquiring, and developing new product candidates; |
• | obtaining and maintaining patent protection, regulatory exclusivity, and other intellectual property-related protection, both in the United States and internationally; |
• | enforcing and defending our rights in our intellectual property portfolio, including our licensed intellectual property; |
• | negotiating favorable terms in any partnership, collaboration, licensing, or other arrangements that may be necessary to develop, manufacture, or commercialize our product candidates; and |
• | attracting, hiring, and retaining qualified personnel. |
• | The success of our product candidates will depend on numerous factors, including the following: |
• | successful and timely completion of our ongoing clinical trials; |
• | initiation and successful patient enrollment and completion of additional clinical trials on a timely basis; |
• | efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval; |
• | raising additional funds necessary to complete the clinical development of and to commercialize of our product candidates; |
• | timely receipt of marketing approvals for our product candidates from applicable regulatory authorities; |
• | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |
• | the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers; |
• | the maintenance of existing or the establishment of new scaled production arrangements with third-party manufacturers to obtain finished products that are appropriately packaged for sale; |
• | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |
• | protection of our rights in our intellectual property portfolio, including our licensed intellectual property; |
• | successful launch of commercial sales following any marketing approval; |
• | a continued acceptable safety profile following any marketing approval; |
• | commercial acceptance by patients, the medical community, and third-party payors; and |
• | our ability to compete with other therapies. |
• | size and nature of the patient population; |
• | severity of the disease under investigation; |
• | availability and efficacy of approved drugs for the disease under investigation; |
• | patient eligibility criteria for the trial in question; |
• | efforts to facilitate timely enrollment in clinical trials; |
• | patient referral practices of physicians; |
• | clinicians’ and patients’ awareness of, and perceptions as to the potential advantages and risks of, our product candidates in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; |
• | the ability to monitor patients adequately during and after treatment; |
• | competing ongoing clinical trials for the same indications as our product candidates; |
• | proximity and availability of clinical trial sites for prospective patients; |
• | whether we become subject to a partial or full clinical hold on any of our clinical trials; and |
• | continued enrollment of prospective patients by clinical trial sites, including delays due to pandemics, wars etc. that can impact patient willingness to participate and travel for investigative therapy and reductions in clinical trial site staff and services. |
• | obtaining regulatory approval to commence a trial; |
• | delays in reaching, or the inability to reach, agreement on acceptable terms with prospective contract research organizations (“CROs”), clinical trial sites, laboratory service providers, companion diagnostic development partners, contract manufacturing organizations, or CMOs, and other service providers we may engage to support the conduct of our clinical trials; |
• | obtaining IRB approval at each clinical trial site; |
• | recruiting a sufficient number of suitable patients to participate in a trial; |
• | patients failing to comply with trial protocol or dropping out of a trial, rendering them not evaluable for study endpoints; |
• | clinical trial sites deviating from trial protocol or dropping out of a trial; |
• | the availability of any applicable combination therapies; |
• | developments in the safety and efficacy of any applicable combination therapies; |
• | the need to add new clinical trial sites; or |
• | delays in the testing, validation and manufacturing of product candidates and the delivery of these product candidates to clinical trial sites. |
• | receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials; |
• | negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain drug development programs; |
• | regulators or IRBs may not authorize us, our collaborators, or our investigators to commence a clinical trial or to conduct a clinical trial at a prospective site; |
• | the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated, or participants dropping out of these clinical trials at a higher rate than anticipated; |
• | third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects, safety or efficacy concerns, or any particular combination therapy or other unexpected characteristics or risks; |
• | the cost of clinical trials of our product candidates being greater than anticipated; |
• | for clinical trials testing combination treatment of our product candidates with third-party drug products, delays in procuring such third-party drug products and the delivery of such third-party drug products to clinical trial sites, or the inability to procure such third-party drug products at all; and |
• | regulators revising the requirements for approving our product candidates, including as a result of newly approved agents changing the standard of care of an indication. |
• | the efficacy and safety profile as demonstrated in clinical trials; |
• | the timing of market introduction of the product candidate as well as competitive products; |
• | the approval of other new therapies for the same indications; |
• | the clinical indications for which the product candidate is approved; |
• | restrictions on the use of our products, if approved, such as boxed warnings, contraindications in labeling, or restrictions on use of our products together with other medications, or a risk evaluation and mitigation strategy (“REMS”), if any, which may not be required of alternative treatments and competitor products; |
• | the potential and perceived advantages of product candidates over alternative treatments or in combination therapies; |
• | the cost of treatment in relation to alternative treatments; |
• | the availability of coverage and adequate reimbursement and pricing by third parties and government authorities; |
• | relative convenience and ease of administration; |
• | the effectiveness of sales and marketing efforts; |
• | the willingness of the target population to try new therapies and of physicians to prescribe these therapies; and |
• | unfavorable publicity relating to the product candidate. |
• | generating sufficient data to support the initiation or continuation of clinical trials; |
• | obtaining regulatory permission to initiate clinical trials; |
• | contracting with the necessary parties to conduct clinical trials; |
• | the successful enrollment of patients in, and the completion of, clinical trials; |
• | the timely manufacture of sufficient quantities of the product candidate, and any combination therapy, for use in clinical trials; and |
• | acceptable adverse profile in the clinical trials. |
• | If we or our partners, or any third party, are unable to successfully develop companion diagnostics in the future in our product candidates, or experience delays in doing so: |
• | the development of our product candidates may be adversely affected if we are unable to appropriately select patients for enrollment in our planned clinical trials; |
• | our product candidates may not receive marketing approval if their safe and effective use depends on a companion diagnostic; and |
• | we may not realize the full commercial potential of any product candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients targeted by our product candidates. |
• | the FDA, EMA, or comparable foreign regulatory authorities may disagree with the design, implementation, or results of our clinical trials; |
• | the FDA, EMA, or comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective, or have undesirable or unintended side effects, toxicities, or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; |
• | the population studied in the clinical program may not be sufficiently broad or representative to assure safety and efficacy in the full population for which we seek approval, including for example due to biologic and genetic differences that might occur in subjects in certain populations such as defined by race or other factors; |
• | we may be unable to demonstrate to the FDA, EMA, or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio when compared to the standard of care is acceptable; |
• | the FDA, EMA, 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 sufficient to support the submission of a Biologics License Application (“BLA”), New Drug Application (“NDA”), or other submission or to obtain regulatory approval in the United States or elsewhere; |
• | we may be unable to demonstrate to the FDA, EMA, or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for a proposed indication is acceptable; |
• | the FDA, EMA, or comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
• | the approval policies or regulations of the FDA, EMA, or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | regulatory authorities may withdraw approvals of such product and cause us to recall our products; |
• | regulatory authorities may require additional warnings on the label or impose a more restrictive, narrower indication for use of the agent; |
• | we may be required to change the way the product is administered or conduct additional clinical trials or post-approval studies; |
• | we may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements, such as boxed warning on the packaging, to assure safe use; |
• | we could be sued and held liable for harm caused to patients; and |
• | our reputation may suffer. |
• | issue warning letters that would result in adverse publicity; |
• | impose civil or criminal penalties; |
• | suspend or withdraw regulatory approvals; |
• | suspend any of our ongoing clinical trials; |
• | refuse to approve pending applications or supplements to approved applications submitted by us; |
• | impose restrictions on our operations, including closing our contract manufacturers’ facilities; |
• | seize or detain products; or |
• | require a product recall. |
• | the demand for our products after obtaining any regulatory approval; |
• | our ability to receive or set a price that we believe is fair for our products; |
• | our ability to generate revenue and achieve or maintain profitability; |
• | the level of taxes that we are required to pay; and |
• | the availability of capital. |
• | comply with the laws of the FDA, EMA and other comparable foreign regulatory authorities; |
• | provide true, complete and accurate information to the FDA, EMA and other comparable foreign regulatory authorities; |
• | comply with manufacturing standards we have established; |
• | comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or |
• | report financial information or data accurately or to disclose unauthorized activities to us. |
• | The federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, 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 a federal healthcare program, such as the Medicare and Medicaid programs. 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. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. |
• | Federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, impose criminal and civil penalties, including through civil actions, against individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other third-party payors that are false or fraudulent, or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation. |
• | The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created new federal criminal statutes that prohibit 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 by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security, and transmission of individually identifiable health information without appropriate authorization. |
• | The federal Physician Payment Sunshine Act, created under the ACA, and its implementing regulations, require manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the HHS under the Open Payments Program, information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. |
• | Federal consumer protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers. |
• | State laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers and other potential referral sources. |
• | State laws also require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensations, and other remuneration, and items of value provided to healthcare professionals and entities. |
• | State and foreign laws also govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
• | those governing laboratory procedures; |
• | the generation, handling, use, storage, treatment and disposal of hazardous and regulated materials and wastes; |
• | the emission and discharge of hazardous materials into the ground, air and water; and |
• | employee health and safety. |
• | identifying, recruiting, integrating, maintaining, and motivating additional employees; |
• | managing our internal development efforts effectively, including the clinical and FDA and EMA review process for our current and any future product candidates, while complying with any contractual obligations to contractors and other third parties we may have; and |
• | improving our operational, financial and management controls, reporting systems and procedures. |
• | 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; |
• | rejection or qualification of foreign clinical trial data by the competent authorities of other 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 anti-corruption compliance and record-keeping that may fall within the purview of the FCPA, its accounting provisions or its anti-bribery provisions, or provisions of anti-corruption or anti-bribery laws in other countries. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | the sublicensing of patent and other rights under our existing collaborative development relationships and any collaboration relationships we might enter into in the future; |
• | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
• | the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our current and future licensors and us; and |
• | the priority of invention of patented technology. |
• | others may make products that are similar to any product candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we license or may own in the future; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights; |
• | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
• | we may not develop additional proprietary technologies that are patentable; and |
• | we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property. |
• | the possible failure of the third party to manufacture our product candidates according to our specifications; |
• | the possible failure of the third party to manufacture our product candidate according to our schedule, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them; |
• | the possible failure of our third-party manufacturer to procure raw materials from third-party suppliers and potential exposure to supply chain issues impacting delivery dates, quality, quantity and pricing of raw materials, including due to the COVID-19 pandemic, which may result in additional costs and delays in production of clinical trial materials, commercial product and regulatory approvals; |
• | the possible termination or nonrenewal of agreements by our third-party contractors at a time that is costly or inconvenient for us; |
• | the possible breach by the third-party contractors of our agreements with them; |
• | the failure of third-party contractors to comply with applicable regulatory requirements; |
• | the possible mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; |
• | the possibility of clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or, following approval by regulatory authorities, of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and |
• | the possible misappropriation of our proprietary information, including our trade secrets and know-how. |
• | counterparties generally have significant discretion, if not total control, in determining the efforts and resources that they will apply to these development efforts; |
• | counterparties may not properly or adequately obtain, maintain, enforce, or defend intellectual property or proprietary rights relating to our intellectual property or may use our proprietary information in such a way as to expose us to potential litigation or other intellectual property-related proceedings, including proceedings challenging the scope, ownership, validity, and enforceability of our intellectual property; |
• | counterparties may own or co-own with us intellectual property covering their product candidates, and, in such cases, we typically will not have the exclusive right to commercialize such intellectual property or their product candidates based on the terms of the licensing agreement; |
• | we may need the cooperation of these counterparties to enforce or defend any intellectual property we contribute to the program; |
• | counterparties typically will control the interactions with regulatory authorities related to their product candidates, which may impact our ability to obtain and maintain regulatory approval of our own product candidates; |
• | disputes may arise between the counterparties and us that result in the delay or termination of the research, development, or commercialization of our product candidates or research programs or that result in costly litigation or arbitration that diverts management attention and resources; |
• | counterparties may decide to not pursue development and commercialization of any product candidates that are derived from our licensed technology, or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the counterparties’ strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities, or counterparties may elect to fund or commercialize a competing product; |
• | counterparties could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates or research programs if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; |
• | counterparties may not commit sufficient resources to the marketing and distribution of their product candidates, resulting in lower royalties to us; |
• | counterparties may grant sublicenses to our technology or undergo a change of control, and the sublicensees or new owners may decide to pursue a strategy with respect to the program which is not in our best interest; |
• | counterparties may become bankrupt, which may significantly delay our research or development programs, or may cause us to lose access to valuable technology, know-how, or intellectual property of the counterparty relating to our technology in relation to the terms of the licensing agreement; |
• | if these counterparties do not satisfy their obligations under our agreements with them, or if they terminate our licensing agreements with them, we may be adversely impacted; and |
• | licensing agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. |
• | exposure to unknown liabilities; |
• | increased operating expenses and cash requirements; |
• | the assumption of additional indebtedness or contingent liabilities; |
• | the issuance of our equity securities; |
• | assimilation of operations, intellectual property, and products of an acquired company, including costs and difficulties associated with integrating new personnel; |
• | the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition; |
• | retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships; |
• | impairment of relationships with key collaborators and other counterparties of any acquired businesses due to changes in management and ownership; |
• | risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and marketing approvals; and |
• | our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs. |
• | delays or difficulties in enrolling and retaining subjects, including elderly subjects, who are at a higher risk of severe illness or death from COVID-19, in our ongoing clinical trials and our future clinical trials; |
• | delays or difficulties in clinical site initiation, including due to difficulties in staffing and recruiting at clinical sites; |
• | difficulties interpreting data from our clinical trials due to the possible effects of COVID-19 on subjects; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of clinical trials; |
• | interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others; |
• | limitations in resources, including our employees, that would otherwise be focused on the conduct of our business or our current or planned clinical trials or preclinical research, including because of sickness, the desire to avoid contact with large groups of people, or restrictions on movement or access to our facility as a result of government-imposed “shelter in place” or similar working restrictions; |
• | interruptions, difficulties or delays arising in our existing operations and company culture as a result of some or all of our employees working remotely, including those hired during the COVID-19 pandemic; |
• | delays in receiving approval from regulatory authorities to initiate our clinical trials; |
• | interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such studies; |
• | interruptions or delays in the operations of the FDA or other domestic or foreign regulatory authorities, which may impact review and approval timelines; |
• | delays in receiving the supplies, materials and services needed to conduct clinical trials and preclinical research; |
• | changes in regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs or require us to discontinue the clinical trial altogether; |
• | interruptions or delays to our development pipeline; |
• | delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel; and |
• | refusal of the FDA to accept data from clinical trials in affected geographies outside of the United States. |
• | the impact of the COVID-19 pandemic on our financial condition and the results of operations; |
• | our operating and financial performance and prospects; |
• | our quarterly or annual earnings or those of other companies in our industry compared to market expectations; |
• | conditions that impact demand for our products and/or services; |
• | future announcements concerning our business, our clients’ businesses or our competitors’ businesses; |
• | the public’s reaction to our press releases, other public announcements and filings with the SEC; |
• | the market’s reaction to our reduced disclosure and other requirements as a result of being an “emerging growth company” under the Jumpstart Our Business Startups Act (the “JOBS Act”); |
• | the size of our public float; |
• | coverage by or changes in financial estimates by securities analysts or failure to meet their expectations; |
• | market and industry perception of our success, or lack thereof, in pursuing our growth strategy; |
• | strategic actions by us or our competitors, such as acquisitions or restructurings; |
• | changes in laws or regulations which adversely affect our industry or us; |
• | privacy and data protection laws, privacy or data breaches, or the loss of data; |
• | changes in accounting standards, policies, guidance, interpretations or principles; |
• | changes in senior management or key personnel; |
• | issuances, exchanges or sales, or expected issuances, exchanges or sales of our capital stock; |
• | changes in our dividend policy; |
• | adverse resolution of new or pending litigation against us; and |
• | changes in general market, economic and political conditions in the United States and global economies or financial markets, including those resulting from natural disasters, terrorist attacks, acts of war and responses to such events. |
• | a limited availability of market quotations for our securities; |
• | reduced liquidity for our securities; |
• | a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of our common stock; |
• | a limited amount of analyst coverage; and |
• | a decreased ability to issue additional securities or obtain additional financing in the future. |
• | a staggered board, which means that our Board is classified into three classes of directors with staggered three-year terms and directors are only able to be removed from office for cause; |
• | limitations on convening special stockholder meetings, which could make it difficult for our stockholders to adopt desired governance changes; |
• | a prohibition on stockholder action by written consent, which means that our stockholders are only be able to take action at a meeting of stockholders and are not able to take action by written consent for any matter; |
• | a forum selection clause, which means certain litigation against us can only be brought in Delaware; |
• | the authorization of undesignated preferred stock, the terms of which may be established and shares of which may be issued without further action by our stockholders; and |
• | advance notice procedures, which apply for stockholders to nominate candidates for election as directors or to bring matters before an annual meeting of stockholders. |
• | our success in retaining or recruiting, or changes required in, our officers, key employees or directors following the Business Combination; |
• | our public securities’ potential liquidity and trading; |
• | the lack of a market for our securities; |
• | our financial performance following this offering; |
• | failure to realize the anticipated benefits of the Business Combination; |
• | the outcome of any legal proceedings that may be instituted against us related to the Business Combination; |
• | the timing and focus of Apexigen’s current and future clinical trials, and the reporting of data from those trials; |
• | Apexigen’s ability to obtain and maintain regulatory approval of its product candidates; |
• | Apexigen’s estimates of the number of patients in the United States who suffer from the diseases it is targeting and the number of patients that will enroll in clinical trials; |
• | the timing or likelihood of regulatory filings and approvals for Apexigen’s product candidates for various diseases; |
• | Apexigen’s plans relating to commercializing its product candidates, if approved, including which indications will be pursued; |
• | the ability of Apexigen’s clinical trials to demonstrate safety and efficacy, and other positive results, of its product candidates; |
• | the beneficial characteristics, safety, efficacy, and therapeutic effects of Apexigen’s product candidates; |
• | the development of competitors’ product candidates; |
• | existing regulations and regulatory developments in the United States and other jurisdictions; |
• | the need to hire additional personnel and our ability to attract and retain such personnel; |
• | Apexigen’s plans and ability to obtain, maintain, enforce, or protect intellectual property rights; |
• | Apexigen’s continued reliance on third parties to conduct additional clinical trials of its product candidates, and for the manufacture of its product candidates for preclinical studies and clinical trials; and |
• | the success of Apexigen’s licensing agreements. |
• | audited historical financial statements of BCAC for the year ended December 31, 2021 filed with this prospectus; |
• | unaudited historical condensed financial statements of BCAC as of and for the six months ended June 30, 2022 filed with this prospectus; |
• | audited historical financial statements of Legacy Apexigen for the year ended December 31, 2021 filed with this prospectus; |
• | unaudited historical condensed financial statements of Legacy Apexigen as of and for the six months ended June 30, 2022 filed with this prospectus; and |
• | other information relating to BCAC and Apexigen included in this prospectus , including the Business Combination Agreement and the description of certain terms thereof and the financial and operational condition of BCAC and Apexigen. |
• | the Merger of Merger Sub, the wholly owned subsidiary of BCAC, with and into Legacy Apexigen, with Legacy Apexigen as the surviving company; |
• | the cancellation of each issued and outstanding share of Legacy Apexigen’s capital stock (including shares of Apexigen capital stock resulting from the conversion of Legacy Apexigen’s preferred stock or the exercise of Legacy Apexigen Options or Legacy Apexigen Warrants) and the conversion into the right to receive a number of shares of Combined Company common stock based on the Exchange Ratio; |
• | the conversion on a net-exercise basis of one Legacy Apexigen Warrant (the “Convertible Warrant”), pursuant to its terms, immediately prior to the Closing into shares of Combined Company common stock based on the Exchange Ratio; |
• | the exchange of an outstanding Legacy Apexigen Warrant (other than the Convertible Warrant) into a warrant exercisable for shares of Combined Company common stock with the same terms except for the number of shares exercisable and the exercise price, each of which was adjusted using the Exchange Ratio; and |
• | the exchange of all outstanding vested and unvested Legacy Apexigen Options into Combined Company Options exercisable for shares of Combined Company common stock with the same terms. except for the number of shares exercisable and the exercise price, each of which was adjusted using the Exchange Ratio. |
• | PIPE Investment: Issuance and sale of 1,452,000 PIPE Units at a purchase price of $10.00 per unit pursuant to the PIPE Investment. The PIPE Investors purchased units, each of which includes one share of Combined Company common stock and one-half of one warrant to purchase a share of Combined Company common stock. The PIPE Investment resulted in the issuance of 1,452,000 shares of Combined Company common stock and 726,000 PIPE Warrants. In addition, shortly after the Closing Apexigen anticipates issuing and selling 50,000 additional PIPE Units for proceeds of $500,000. These additional PIPE Units have not been reflected in the pro forma. |
• | Lincoln Park Purchase Arrangement: BCAC, Legacy Apexigen and Lincoln Park entered into a purchase agreement pursuant to which the Combined Company may direct Lincoln Park to purchase up to $50.0 million of Combined Company common stock from time to time over a 24-month period following the Closing, subject to certain limitations contained in the Lincoln Park Purchase Agreement. At the Closing, the Combined Company issued 150,000 shares of Combined Company common stock to Lincoln Park. 90 days after the Closing, the Combined Company is obligated to issue $1.5 million of shares of Combined Company common stock to Lincoln Park at a price per share equal to the arithmetic average of the closing sale price for Combined Company common stock during the 10 consecutive business days immediately preceding the share delivery date, not to exceed 500,000 shares. |
• | Forfeited Sponsor Shares: In connection with the Closing, the Sponsor forfeited 436,021 shares of common stock. |
• | BCAC Stockholder Redemptions: On April 26, 2022, BCAC held a special meeting of its stockholders. BCAC stockholders approved a proposal to amend BCAC’s Amended and Restated Certificate of Incorporation to extend the date by which BCAC must consummate a business combination transaction from May 2, 2022 on a monthly basis up to November 2, 2022. In connection with this special meeting, BCAC Public Stockholders elected to redeem 688,408 shares of common stock for total redemption proceeds of $7.0 million (the “April Partial Redemption”). The April Partial Redemption is reflected in the unaudited historical condensed financial statements of BCAC as of June 30, 2022. In addition, BCAC Public Stockholders elected to redeem 4,618,607 additional shares of Combined Company common stock for $47.2 million upon the Merger Closing (the “Closing Redemption”). These redemptions have been reflected below. |
• | Sponsor Extension Note: In May and June 2022, BCAC issued non-convertible unsecured promissory notes in the principal amount of $0.5 million to the Sponsor (“Extension Notes”) in exchange for funds that were deposited into the Trust Account. The Extension Notes were issued in connection with the approval of the Amendment to BCAC’s Amended and Restated Certificate of Incorporation and extension (the “Extension”) of the date by which the Company was required to consummate a business combination transaction from May 2, 2022 (the date which was 15 months from the closing date of the Company’s initial public offering of units) and constitute monthly contributions. The Sponsor was repaid in cash upon the Merger Closing. These transactions have been reflected below. |
• | Sponsor Working Capital Note: On May 2, 2022, BCAC issued an additional convertible unsecured promissory note (the “Working Capital Note”) in the principal amount of $0.4 million to the Sponsor. The Working Capital Note was issued to provide BCAC with additional working capital during the Extension and will not be deposited into the Trust Account. BCAC issued the Working Capital Note in consideration for a loan from the Sponsor to fund BCAC’s working capital requirements. As of the Closing Date, approximately $0.4 million was drawn and approximately $65,000 was not drawn of the Working Capital Note principal amount. The Working Capital Note was settled in cash upon the Merger closing. |
Shares |
% |
|||||||
BCAC Public Stockholders (1) |
442,985 | 2.1 | % | |||||
Sponsor (2) |
1,190,979 | 5.6 | % | |||||
BCAC IPO Underwriter and Certain of Its Employees (3) |
57,500 | 0.2 | % | |||||
Legacy Apexigen equity holders (4) |
18,151,571 | 84.6 | % | |||||
PIPE Investors (5) |
1,452,000 | 6.8 | % | |||||
Lincoln Park (6) |
150,000 | 0.7 | % | |||||
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Combined Company common stock outstanding at Merger Closing |
21,445,035 | 100.0 | % | |||||
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(1) | Amount reflects the April Partial Redemption and the Closing Redemption. Amount excludes 2,875,000 outstanding Public Warrants issued in connection with the BCAC IPO as such securities are not exercisable until August 28, 2022, the date that is 30 days after the Merger Closing. |
(2) | The Sponsor holds 1,190,979 shares of BCAC Common Stock, comprised of 1,380,000 Founder Shares and 247,000 shares of BCAC Common Stock issued as constituent securities of the units issued in the Private Placement, net of 436,021 shares forfeited by the Sponsor upon the Closing. This amount excludes 123,500 Private Warrants. |