S-1/A 1 forms-1a.htm

 

As filed with the Securities and Exchange Commission on November 15 , 2022

 

Registration No. 333-265400

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

AMENDMENT NO. 7 TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

BIOLIFE4D CORPORATION

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware   2836   81-4586116

(State or Other Jurisdiction of

Incorporation or Organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

 

318 Half Day Road, Suite 201

Buffalo Grove, IL 60089

(224) 602-9569

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

 

 

National Registered Agents, Inc.

1209 Orange Street

Wilmington, DE 19801

(302) 658-7581

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

 

 

Copies to:

 

 

Lynne Bolduc, Esq.

 

Anthony W. Basch, Esq.

Yan (Natalie) Wang, Esq.

FitzGerald Kreditor Bolduc Risbrough LLP   Kaufman & Canoles, P.C.
2 Park Plaza, Suite 850   1021 East Cary Street, Suite 1400
Irvine, California 92614   Richmond, VA 23219
Tel: (949) 788-8900   Tel: (804) 771-5700
Fax: (949) 788-8980   Fax: (888) 360-9092

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

 

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, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting 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 Act or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 
 

 

The information contained in this preliminary 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 preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 

PRELIMINARY PROSPECTUS   SUBJECT TO COMPLETION   DATED NOVEMBER 15 , 2022

 

Up to 2,419,354 Common Units, Each Consisting of One Share of Common Stock and Two Warrants to Each Purchase One Share of Common Stock

 

 

BIOLIFE4D CORPORATION

 

This is a firm commitment initial public offering of shares of common stock, $0.00001 par value per share, and warrants (the “Warrants”) to purchase shares of common stock, of BIOLIFE4D CORPORATION (“we,” “us”, or the “Company”). We are offering 2,419,354 units (the “Common Units”), each Common Unit consisting of one share of common stock and two Warrants to each purchase one share of common stock. The Common Units have no stand-alone rights and will not be certificated or issued as stand-alone securities. The shares of common stock and Warrants are immediately separable and will be issued separately. The offering also includes the shares of common stock issuable from time to time upon exercise of the Warrants.

 

Prior to this offering, there has been no public market for our common stock or Warrants. We anticipate that the initial public offering price of per Common Unit will be between $5.20 and $7.20. The exercise price of each Warrant will be $5.95 (equal to the public offering price per Common Unit, less the price per Warrant included within the Common Unit attributed by Nasdaq, based on an assumed public offering price of $6.20 per Common Unit, the midpoint of the price range of the Common Units) per share. The number of Common Units offered in this prospectus and all other applicable information has been determined based on an assumed public offering price of $6.20 per Common Unit, which is the midpoint of the above range. Therefore, the assumed public offering price per Common Unit used throughout this prospectus may not be indicative of the actual public offering price for the common stock.

 

There are certain adjustments to the exercise price of the Warrants on the date that is 90 calendar days immediately following the initial issuance date of the Warrants. On such date, the exercise price of the Warrants will be adjusted to be equal to the greater of (a) 50% of the Initial Exercise Price or (b) 100% of the lowest daily volume weighted average price per share of common stock occurring on any day between the initial exercise date and 90 calendar days following the issuance date of the Warrants (the “Reset Price”). The lowest Reset Price is $2.98, which is 50% of Initial Exercise Price per share.

 

We have applied to list our common stock and Warrants on the Nasdaq Capital Market (“Nasdaq”) under the symbols “SAVU” and “SAVUW,” respectively. If those applications are not approved, we will not complete this offering.

 

We refer to the shares of common stock, the Warrants, and the shares issued or issuable upon exercise of the Warrants collectively, as the “securities.” (See “Description of Securities.”)

 

We are an “emerging growth company” under the federal securities laws and have elected to comply with certain reduced public company reporting requirements. (See “Prospectus Summary—Implications of Being an Emerging Growth Company.”)

 

Investing in our securities involves a high degree of risk. (See “Risk Factors” beginning on page 6.)

 

Neither the Securities and Exchange Commission (“SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

  

Per Common

Unit

    Total 
Initial public offering price  $

6.20

    $

14,999,995

 
Underwriting discounts and commissions(1)  $

0.496

    $

1,200,000

 
Proceeds to us, before expenses(2)  $

5.704

    $

13,799,995

 

 

(1) Underwriting discounts and commissions do not include a non-accountable expense allowance equal to 1.0% of the initial public offering price (excluding proceeds received from exercise of the underwriter’s overallotment option) payable to the underwriter in this offering. (See “Underwriting.”)
(2) We estimate that our total expenses for the offering will be approximately $335,000 in addition to underwriting discounts.

 

We have granted a 45-day option to the underwriter to purchase, at the public offering price, less the underwriting discounts and commissions, up to an additional 15% of the total number of securities offered by us in this offering, which equates to up to 362,903 additional shares of common stock and/or up to 725,806 additional Warrants to purchase up to 725,806 shares of common stock, solely to cover overallotments, if any.

 

The underwriter expects to deliver the securities to investors on or about [  ], 2022.

 

Aegis Capital Corp.

 

The date of this prospectus is [  ], 2022

 

 
 

  

TABLE OF CONTENTS

 

   
Prospectus Summary 1
Risk Factors 6
Cautionary Note Concerning Forward-Looking Statements 25
Use of Proceeds 26
Capitalization 27
Dilution 28
Dividend Policy 29
Management’s Discussion and Analysis of Financial Condition and Results of Operations 30
Our Business 35
Management 47
Executive and Director Compensation 57
Certain Relationships and Related Party Transactions 62
Principal Stockholders 63
Description of Securities 64
Shares Eligible For Future Sale 69
Certain Material Federal Income Tax Considerations 71
Underwriting 76
Legal Matters 80
Experts 80
Where You Can Find More Information 80
Index to Financial Statements F-1

 

i
 

 

ABOUT THIS PROSPECTUS

 

As used in this prospectus, unless the context otherwise requires or indicates, references to “the Company,” “we,” “our,” “ourselves,” and “us” refer to BIOLIFE4D CORPORATION.

 

You should rely only on the information contained in this prospectus and any free writing prospectus prepared by us or on our behalf that we have referred you to. Neither we nor the underwriter have authorized anyone to provide you with additional or different information. If anyone provides you with additional, different, or inconsistent information, you should not rely on it. We and the underwriter take no responsibility for, and can provide no assurance as to, the reliability of any other information that others may give you. This prospectus is an offer to sell only the securities offered hereby and only under circumstances and in jurisdictions where it is lawful to do so. We and the underwriter are not making an offer of these securities in any state, country, or other jurisdiction where the offer is not permitted. You should not assume that the information in this prospectus or any free writing prospectus is accurate as of any date other than the date of the applicable document regardless of its time of delivery or the time of any sales of our securities. Our business, financial condition, results of operations and cash flows may have changed since the date of the applicable document.

 

This prospectus describes the specific details regarding this offering and the terms and conditions of our securities being offered hereby and the risks of investing in our common stock. For additional information, please see the section entitled “Where You Can Find More Information.”

 

You should not interpret the contents of this prospectus or any free writing prospectus to be legal, tax advice, business, or financial advice. You should consult with your own advisors for that type of advice and consult with them about the legal, tax, business, financial, and other issues that you should consider before investing in our securities.

 

Unless otherwise stated, all information in this prospectus assumes that the underwriters have not exercised their option to purchase additional shares of common stock and/or Warrants.

 

ii
 

 


MARKET AND INDUSTRY DATA

 

This prospectus includes industry and trade association data, forecasts, and information that we have prepared based, in part, upon data, forecasts, and information obtained from independent trade associations, industry publications and surveys, government agencies, and other independent information publicly available to us. Statements as to our market position are based on market data currently available to us. Industry publications, surveys, and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable. Although we believe these sources are reliable, we have not independently verified the information obtained from these sources. Some data is also based on our good faith estimates, which are derived from management’s knowledge of the industry and independent sources.

 

We believe our internal research is reliable, even though such research has not been verified by any independent sources. While we are not aware of any misstatements regarding our industry data presented herein, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this prospectus.

 

In addition, forward-looking information obtained from these sources is subject to the same qualifications and the additional uncertainties regarding the other forward-looking statements in this prospectus. Trademarks used in this prospectus are the property of their respective owners, although for presentational convenience we may not use the ® or the ™ symbols to identify such trademarks. In addition, certain market and industry data has been obtained from publicly available industry publications. These sources generally state that the information they provide has been obtained from sources believed to be reliable, but that the accuracy and completeness of the information are not guaranteed. We have not independently verified the data obtained from these sources. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and additional uncertainties regarding the other forward-looking statements in this prospectus.

 

iii
 

 

PROSPECTUS SUMMARY

 

This summary highlights information contained elsewhere in this prospectus, but it does not contain all of the information that you may consider important in making your investment decision. Therefore, you should read this entire prospectus carefully, including, in particular, the “Risk Factors” section of this prospectus.

 

Our Company

 

BIOLIFE4D CORPORATION is a pioneering biotech company that plans to leverage current advances in life sciences and cardiac tissue engineering to build human hearts suitable for implantation – potentially lifesaving technology that ultimately gives patients the gift of time.

 

Operated by seasoned business leaders and guided by world-class biomedical engineers and life sciences experts, we are driving a movement to transform the treatment of heart disease which is the leading cause of death among both men and women globally.

 

We are committed to perfecting the technology to make viable organ replacement an accessible and affordable reality, as well as mini-hearts for cardiotoxicity testing. We believe that our groundbreaking approach converges recent breakthroughs in regenerative medicine, adult stem cell biology, 3D printing techniques, and computing technology that could make organ replacement commercially viable and commonplace globally.

 

We plan to create a patient-specific, fully functioning heart through 3D bioprinting using the patient’s own cells – eliminating the well-known challenges of organ rejection and long donor waiting lists that plague existing organ transplant methods.

 

We will not have to make an exact copy or even recreate every feature set of the desired organ; it will only need to facilitate the minimum feature set which recreates the core properties of the organ. It is important to note that we do not believe we need to invent new technology, but rather improve, adopt, and optimize current technologies to create what we plan to be a commercially viable and sustainable process. We seek to improve, optimize, adapt, and capitalize on current technologies to create a commercially viable and sustainable process solution. We plan to strategically position ourselves at the center of an unprecedented convergence of regenerative medicine, stem cell biology, additive manufacturing (3D printing), and computing technology – all having reached a level of maturity whereby we believe that commercially viable bioprinting solutions can be created through optimization, not invention. While it is impossible to predict the exact amount of time it will take to fully optimize this process, we believe that by creating the optimal circumstances to accelerate current efforts, we will be able to achieve a solution. Inherent in the time frame is the ultimate interaction of the United Stated Food and Drug Administration (“FDA”) within this time frame. It is impossible to predict the exact time frame of the FDA approval process, but we plan to work closely with the FDA at the appropriate time in an attempt to help reduce the time for necessary approvals.

 

We are still in the research and development stage. Our key research focus is currently on the development of a functional mini-heart that can be utilized for cardiotoxicity testing. Continued development relating to our other potential commercialization opportunities we are planning, including cardiac valves, patches, grafts, and ultimately a full heart viable for transplantation is currently curtailed as we focus on the mini-heart development, our initial commercialization opportunity. Our mini-heart, once optimized, will have four chambers, valves, greater vessels, musculature, electrical activity, and capable of generating intraluminal pressures. Currently, we have made significant progress towards the development and optimization of a functional mini-heart. We have been successful at bioprinting a heart, which has all four chambers needed for functional performance, and hence, for cardiotoxicity testing. The mini-heart has been populated with iPSC-CMs, cardiomyocytes that are derived from induced pluripotent stem cells. We are currently working on optimizing the final variables (i.e., printer settings, etc.) which we believe are necessary to successfully conduct cardiotoxicity testing and commercialize the mini-heart.

 

As of the date of this Prospectus, we have not sold any products or generated any revenue from sales. Our products are currently in the preclinical development phase and have not yet received FDA clearance or approval. The FDA’s plans to regulate the 3D printing of human organs for use in implantation are currently unknown.

 

Summary Risk Factors

 

An investment in our securities involves a high degree of risk. You should consider carefully the risks discussed below and described more fully along with other risks under “Risk Factors” in this prospectus before investing in our securities.

 

1
 

 

Risks Related to Biotech Industry

 

  We are attempting to bioengineer human hearts using 3D printing for testing purposes and possible transplantation into humans, which has never been done and may not be possible.
     
  The regulatory approval process of the FDA, other regulatory bodies, and similar foreign authorities is lengthy, expensive, time consuming, and inherently unpredictable.
     
  Device development involves a lengthy and expensive process with uncertain timelines and outcomes, and results of earlier studies may not be predictive of future study results. If the development of our 3D bioprinted organs is unsuccessful or delayed, we may be unable to obtain required regulatory approvals and we may be unable to commercialize our product on a timely basis, if at all.
     
  We rely on a third party to conduct our research and development. If the third-party relationship is terminated or if the third party does not successfully carry out its contractual duties, meet rigorously enforced regulatory standards or meet expected deadlines, we may be unable to complete such study on time, obtain regulatory approval for or commercialize our products, which could force us to delay, limit, reduce or terminate our product development program, future commercialization efforts or other operations.
     
  3D printed organs may fail once transplanted into patients causing serious injury or death to the patients, leading to lawsuits and bad publicity.
     
  We rely in part upon trade secret protection to protect our intellectual property; it may be difficult and costly to protect our proprietary rights and we may not be able to ensure its protection.
     
  We operate in a field of rapid technology change and if we are unable to keep current with technology changes such as other options for heart transplant patients, our commercialization efforts may be negatively impacted.
     
  We face competition in our market from various large and small companies, most of which have greater financial, research and development, production, and other resources than us.
     
  There are currently no definitive regulatory requirements on the sale or use of 3D bioprinted organs.

 

Risks Related to Our Company and this Offering

 

  We are an “emerging growth company” and, as a result of the reduced disclosure and governance requirements available to emerging growth companies, our securities may be less attractive to investors.
     
  There is currently no public market for shares of our common stock and Warrants. If and when we achieve listing on an exchange, the prices of our securities may be volatile and could decline substantially following this offering.
     
  We may incur losses over the next several years and may never achieve or maintain profitability. These factors raise substantial doubt about our ability to continue as a going concern absent obtaining significant additional funding. Since inception, we have incurred significant net losses and may continue to incur net losses in the future.
     
  There is no guarantee that we will ever realize any significant operating revenues or that our operations will ever be profitable. Furthermore, we may not be able to generate sufficient operating cash flows to pay our operating expenses or service our indebtedness. As a result, it is possible you may lose some or all of your investment.
     
  The extent to which the COVID-19 pandemic impacts our results and operations will depend on future developments that are highly uncertain and cannot be predicted.

 

Corporate Information

 

We were formed as a Delaware corporation on November 14, 2016.

 

Our principal executive office is located at 318 Half Day Road, Suite 201, Buffalo Grove, Illinois 60089. Our main telephone number is (224) 602-9569. Our website is https://biolife4d.com/. The information contained on, or that can be accessed through, our website is not incorporated by reference and is not a part of this prospectus.

 

2
 

 

Implications of Being an Emerging Growth Company

 

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies.” These provisions include, among other matters:

 

  an exemption to provide fewer years of financial statements and other financial data in an initial public offering registration statement;
     
  an exemption from the auditor attestation requirement in the assessment of the emerging growth company’s internal control over financial reporting;
     
  an exemption from new or revised financial accounting standards until they would apply to private companies and from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation;
     
  reduced disclosure about the emerging growth company’s executive compensation arrangements; and
     
  no requirement to seek non-binding advisory votes on executive compensation or golden parachute arrangements.

 

We have elected to adopt the reduced disclosure requirements available to emerging growth companies. As a result of these elections, the information that we provide in this prospectus may be different than the information you may receive from other public companies.

 

We would cease to be an “emerging growth company” upon the earliest of: (i) the end of the fiscal year following the fifth anniversary of this offering, (ii) the first fiscal year after our annual gross revenues are $1.235 billion or more, (iii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt securities or (iv) as of the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million as of the end of the second quarter of that fiscal year.

 

Reverse Stock Split

 

Our board of directors and shareholders approved a one for three reverse split of our common stock on August 22, 2022, and filed with the Delaware Secretary of State on August 25, 2022. The reverse split combined each three shares of our outstanding common stock into one share of common stock. No fractional shares were issued in connection with the reverse split, and any fractional shares resulting from the reverse split were rounded up to the nearest whole share. The reverse split did not affect our authorized common stock. All references to common stock, options to purchase common stock, share data, per share data, and related information, as applicable have been adjusted in this prospectus to reflect the split of our common stock as if it had occurred at the beginning of the earliest period presented.

 

3
 

 

THE OFFERING

 

Common Units Offered   We are offering 2,419,354 Common Units, each consisting of one share of common stock and two warrants to each purchase one share of common stock. The Common Units have no stand-alone rights and will not be certificated or issued as stand-alone securities. The shares of common stock and Warrants are immediately separable and will be issued separately in this offering. (See “Description of Securities.”)
     
Warrants  

Each Warrant will have an exercise price of $5.95 (equal to the public offering price per Common Unit, less the price per Warrant included within the Common Unit attributed by Nasdaq, based on an assumed public offering price of $6.20 per Common Unit, the midpoint of the range set forth on the cover page of the prospectus), per share, will be immediately exercisable and will expire five years from the date of issuance. To better understand the terms of the Warrants, you should carefully read the “Description of Securities” section of this prospectus. You should also read the form of Warrant, which is filed as an exhibit to the registration statement that includes this prospectus. Subject to certain exemptions outlined in the Warrant, for a period of two years from the date of issuance of the Warrant, if the Company shall sell, enter into an agreement to sell and subsequently sells, or grants any option to purchase, or sell, enters into an agreement to sell and subsequently sells, or grants any right to reprice, or otherwise dispose of or issues (or announces any offer, sale, grant or any option to purchase or other disposition that subsequently closes) any common stock or convertible security, at an effective price per share less than the exercise price of the Warrant then in effect (a “Dilutive Issuance”), then simultaneously with the consummation of such Dilutive Issuance, the exercise price of the Warrant shall be reduced to equal the effective price per share in such Dilutive Issuance; provided, however, that in no event shall the exercise price of the Warrant be reduced to an exercise price lower than 50% of public offering price per share of common stock in this offering. On the date that is 90 calendar days immediately following the issuance date of the Warrants, the exercise price of the Warrants will adjust to be equal to the greater of (i) $2.98 per share (which shall equal 50% of the exercise price of the Warrants on the issuance date) and (ii) 100% of the lowest daily volume weighted average price per share of common stock occurring on any day between the initial exercise date and 90 calendar days following the issuance date of the Warrant (the “Reset Price”). The lowest Reset Price is $2.98, which is 50% of the offering price per share of common stock, based on an assumed public offering price of $6.20 per Common Unit, the midpoint of the price range of the Common Units, per share. To better understand the terms of the Warrants, you should carefully read the “Description of Securities” section of this prospectus. You should also read the form of Warrant, which is filed as an exhibit to the registration statement that includes this prospectus.

     
Public Offering Price   Each Common Unit is being offered at a price of $6.20.
     

Shares of Common Stock issued and outstanding prior to this offering

 

  3,610,353 shares.
Shares of Common Stock to be outstanding after this offering   6,029,707 shares (assuming no exercise of the over-allotment option, Warrants or Underwriter’s Warrants), or 6,392,610 shares if the underwriter exercises in full its over-allotment option to purchase additional shares of common stock.
     

Over-allotment Option

 

  We have granted the underwriters the option to purchase up to an additional 362,903 shares of our common stock (15% of the shares of common stock sold in the offering), and/or up to 725,806 additional Warrants (15% of the Warrants sold in the offering), in any combination thereof, to cover overallotments, if any, for a period of 45 days from the date of this prospectus. The purchase price to be paid per additional share will be equal to the public offering price of one Common Unit, less the purchase price per Warrant included within the Common Unit and the underwriting discount.
     
Use of Proceeds   We expect to receive net proceeds from this offering of approximately $13,314,995 (assuming an initial public offering price of $6.20 per Common Unit, which is the midpoint of the price range set forth on the cover page of this prospectus), or approximately $15,362,494 if the underwriters exercise in full their overallotment option, after deducting the underwriting discounts and commissions, non-accountable expense allowance, and the estimated offering expenses of approximately $335,000 payable by us. We intend to use the net proceeds from this offering for laboratory equipment; raw materials; laboratory expenses and testing; selling, general, and administrative expenses; working capital; repayment of a working capital loan; and compliance. (See “Use of Proceeds.”)
     
Dividend Policy   We currently intend to retain our future earnings, if any, to finance the development and expansion of our business. The determination to pay dividends will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in any financing instruments, and such other factors as our board of directors deems relevant in its discretion. (See “Dividend Policy.”)
     
Risk Factors   Investing in our common stock involves a high degree of risk. (See “Risk Factors.”)
     
Lock-ups   Our directors, executive officers, and holders of 10% or more of our outstanding common stock, will agree with the underwriter not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our common stock or securities convertible into common stock for a period of 180 days after the closing date of this offering. We will agree not to issue any shares of common stock or securities convertible into common stock, subject to certain exceptions, for a period of 180 days after the closing date of this offering without the consent of the underwriter. (See “Underwriting.”)
     
Stock Exchange Symbol   We have applied to list our common stock and Warrants on the Nasdaq Capital Market under the proposed symbols “SAVU” and “SAVUW,” respectively. However, no assurance can be given that our applications will be approved.

 

Except as otherwise indicated, all information in this prospectus is based on 3,610,353 shares outstanding as of the date of this prospectus, and:

 

Reflects a one for three reverse split of our common stock, which was effected on August 25, 2022;
assumes no exercise of the underwriter’s overallotment option;
assumes no exercise of any Warrants or Underwriter’s Warrants issued in this offering;
excludes 132,001 shares of our common stock issuable upon the exercise of outstanding options to purchase common stock; and
excludes that certain number of shares of our common stock issuable upon conversion of $600,000 of principal plus interest outstanding on convertible promissory notes multiplied by 80% of the price per share of the common stock offered hereby, assuming aggregate gross sales of our equity securities of at least $7.5 million from this Offering (see Note 5 to the Financial Statements for a description of the convertible notes).

 

(See “Description of Securities.”)

 

4
 

 

SUMMARY FINANCIAL DATA

 

The following table presents summary financial data. The statement of operations data for the years ended December 31, 2021, and 2020 and the six months ended September 30, 2022, and 2021 are derived from our audited annual and our unaudited quarterly financial statements. Our historical results are not necessarily indicative. of our results in any future period.

 

You should read the following summary financial data together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus. The summary financial data in this section is not intended to replace our financial statements and the related notes and are qualified in their entirety by the financial statements and related notes included elsewhere in this prospectus.

 

   December 31,   September 30, 
   2021   2020   2022   2021 
Statement of Operations Data                
Expenses                
General and administrative  $993,821   $901,692   $1,688,462   $764,261 
Depreciation and amortization   8,124    6,996    7,967    6,093 
Research and development   780,280    677,220    682,409    684,553 
Total expenses   1,782,225    1,585,908    2,378,838    1,454,907 
                     
Net operating loss   (1,782,225)   (1,585,908)   (2,378,838)   (1,454,907)
                     
Other Income (expenses)                    
Loan forgiveness   397,273    -    -    222,400 
Interest income   154    5,138    91    103 
Interest expense   (110,605)   (120,513)   (112,067)   (81,562)
Net Other Income (expenses)   286,822    (115,375)   (111,976)   140,941 
Loss before income taxes   (1,495,403)   (1,701,283)   (2,490,814)   (1,313,966)
Income taxes   -    -    -    - 
Net loss  $(1,495,403)  $(1,701,283)  $(2,490,814)  $(1,313,966)

 

5
 

 

RISK FACTORS

 

An investment in our common stock involves a high degree of risk and should be considered highly speculative. Before making an investment decision, you should carefully consider the following risk factors, which address the material risks concerning our business and an investment in our common stock, together with the other information contained in this prospectus. If any of the risks discussed in this prospectus occur, our business, prospects, liquidity, financial condition, and results of operations could be materially and adversely affected, in which case the trading price of our common stock could decline significantly, and you could lose all or part of your investment. Some statements in this prospectus, including statements in the following risk factors, constitute forward-looking statements. Please refer to the section entitled “Cautionary Note Concerning Forward-Looking Statements.”

 

Risks Related to Our Business

 

Our Independent Audit Firm Has Expressed in its Report to Our Audited Financial Statements a Substantial Doubt About Our Ability to Continue as a Going Concern.

 

We have not yet begun to generate revenues from our operations to fund our activities and are therefore dependent upon external sources for financing our operations. There is a risk that we will be unable to obtain necessary financing to continue our operations on terms acceptable to us or at all. As a result, our independent audit firm has expressed in its auditors’ report on the financial statements a substantial doubt regarding our ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of the uncertainty regarding our ability to continue as a going concern. This going concern opinion could materially limit our ability to raise additional funds through the issuance of equity or debt securities or otherwise. Future reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. If we cannot continue as a going concern, our shareholders may lose their entire investment.

 

We are Attempting to Bioengineer Human Hearts Using 3D Printing for Testing Purposes and Possible Transplantation into Humans Which Has Never Been Done and May Not be Possible.

 

Our success is dependent upon our ability to 3D print a human heart suitable for testing purposes and viable for transplantation into humans which has never been successfully done by us or any other person or entity. Therefore, our current and planned future business are speculative and subject to numerous risks and uncertainties. Substantial additional research and development activities need to take place before we can begin to produce revenue. There can be no assurance that we will ever generate revenue or be profitable. Should we be unable to successfully 3D print human hearts suitable for testing or viable for human transplantation, or should a competitor be able to do so prior to us being able to do so, your investment may be significantly affected and we may fail. In addition to human hearts, we may attempt to bioengineer other human organs (e.g., livers and kidneys) which future product attempts may be unsuccessful.

 

We Have Limited Operating History and We May Not be Able to Successfully Operate Our Business.

 

We incorporated in November 2016. From incorporation through the third quarter of 2017, our operations were limited to start-up activities and beginning to raise capital through a Tier II Regulation A offering, which commenced in the first quarter of 2018. In the first quarter of 2018, we commenced additional operations, consisting primarily of research and development activities. We thus have a limited operating history and there can be no assurance that our proposed plan of business can be realized in the manner contemplated and, if it cannot be, shareholders may lose all or a substantial part of their investment. We cannot assure you that our past experience will be sufficient to enable us to operate our business successfully or implement our operating policies and business strategies as described in this prospectus. There is no guarantee that we will ever realize any significant operating revenues or that our operations will ever be profitable. Furthermore, we may not be able to generate sufficient operating cash flows to pay our operating expenses or service our indebtedness. You should not rely upon the past performance of our management team as past performance may not be indicative of our future results.

 

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To Date, We Have Had Operating Losses and Do Not Expect to be Profitable for at Least the Foreseeable Future, and Cannot Accurately Predict When We Might Become Profitable.

 

We have been operating at a loss since our inception, and we expect to continue to incur losses for the foreseeable future. Further, we may not be able to generate significant revenues in the future. In addition, we expect to incur substantial operating expenses in order to fund the expansion of our business. As a result, we expect to continue to experience substantial negative cash flow for at least the foreseeable future and cannot predict when, or even if, we might become profitable.

 

We May Not Be Able to Obtain Adequate Financing to Continue Our Operations.

 

We may require additional debt and/or equity financing to pursue our growth and business strategies. These include, but are not limited to enhancing our operating infrastructure and otherwise responding to competitive pressures. Given our limited operating history and existing losses, there can be no assurance that additional financing will be available, or, if available, that the terms will be acceptable to us. Lack of additional funding could force us to curtail substantially our growth plans. Furthermore, the issuance by us of any additional securities pursuant to any future fundraising activities undertaken by us would dilute the ownership of existing shareholders and may reduce the price of our securities.

 

Terms of Subsequent Financing, if Any, May Adversely Impact Your Investment.

 

We may have to engage in common equity, debt, or preferred stock financings in the future. Your rights and the value of your investment in our common stock could be reduced by the dilution caused by future equity issuances, or convertible debt issuances with conversion rates below the then fair market value of our stock at the time of conversion. Interest plus potential amortization of debt issuance costs on debt securities could increase costs and negatively impact operating results. As we are permitted to issue preferred stock pursuant to the terms of our governing documents, preferred stock could be issued in series from time to time with such designation, rights, preferences, and limitations as needed to raise capital. The terms of preferred stock could be more advantageous to those investors than to the holders of our common stock.

 

Our Operating Plan Relies in Large Part Upon Our Assumptions and Analyses. If These Assumptions or Analyses Prove to be Incorrect, Our Actual Operating Results May be Materially Different from Our Forecasted Results.

 

Whether actual operating results and business developments will be consistent with our expectations and assumptions as reflected in our forecast depends on a number of factors, many of which are outside our control, including, but not limited to:

 

  whether we can obtain sufficient capital to sustain and grow our business;
     
  our ability to manage our growth;
     
  results of our research and development activity;
     
  demand for our proposed products;
     
  competition;
     
  our ability to retain existing key management and consultants, to integrate recent hires and to attract, retain, and motivate qualified personnel; and
     
  the overall strength and stability of domestic and international economies.

 

Unfavorable changes in any of these or other factors, most of which are beyond our control, could materially and adversely affect our business, results of operations, and financial condition.

 

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We rely on Johnson & Johnson Innovation, JLABS facilities for a significant portion of our research and development.

 

A majority of our research and development is located at the Texas Medical Center at 2450 Holcombe Boulevard in Houston, Texas managed by Johnson & Johnson Innovation, JLABS personnel. We have an agreement to rent a dedicated portion of the premises designed for the purpose of conducting laboratory research and other laboratory related activities. agreement automatically renews every three months and has been doing so since 2018. If JLABS terminates our licensing agreement, no longer manages the premises, or we otherwise lose access to the laboratory facilities, our research and development will be significantly impacted.

 

Our Future Financial Performance and Our Ability to Commercialize Our Products and Services and to Compete Effectively Will Depend, in Part, On Our Ability to Manage Any Future Growth Effectively.

 

As our operations expand, we expect that we will need to manage additional relationships with various strategic partners, suppliers, and other third parties. Our future financial performance and our ability to commercialize our products and services and to compete effectively will depend, in part, on our ability to manage any future growth effectively. To that end, we must be able to manage our development efforts effectively and hire, train, and integrate additional management, administrative and sales and marketing personnel. Our projected growth will place a significant strain on our administrative, operational, and financial resources. If we are unable to successfully manage our future growth, establish and continue to upgrade our operating and financial control systems, recruit and hire necessary personnel, or effectively manage unexpected expansion difficulties, our financial condition and results of operations could be materially and adversely affected.

 

Changes in The Economy Could Have a Detrimental Impact on Our Business.

 

Changes in the general economic climate could have a detrimental impact on our revenue. It is possible that recessionary pressures and other economic factors (such as declining incomes, future potential rising interest rates, higher unemployment, and tax increases) may adversely affect our business. Any of such events or occurrences could have a material adverse effect on our financial results and on your investment.

 

We Face Competition in Our Market from Various Large and Small Companies, Most of Which Have Greater Financial, Research and Development, Production, and Other Resources than Us.

 

We may face significant competition from other biotechnology companies, and our operating results could suffer if we fail to compete effectively. The biotechnology industry is intensely competitive and subject to rapid and significant technological change. We have competitors both in the United States and internationally, including major biotechnology companies and universities and other research institutions. Many of our competitors have substantially greater financial, technical, and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations. Additional mergers and acquisitions in the biotechnology industries may result in even more resources being concentrated in our competitors. As a result, these companies may obtain regulatory approval, if required, or market acceptance more rapidly than we are able and may be more effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Our ability to compete depends, in part, upon a number of factors outside our control, including the ability of our competitors to develop alternatives that are superior. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring, or licensing on similar products or services that we may develop. There are competing alternatives to our proposed product as well, such as a recent successful pig-to-human heart transplant. If we fail to successfully compete in our market, or if we incur significant expenses in order to compete, it could have a material adverse effect on our results of operations.

 

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We Operate in a Field of Rapidly Changing Technology and if We are Unable to Adapt to Technological Changes, We will not be Able to Effectively Compete.

 

We may fail to anticipate or adapt to technology innovations in a timely manner, or at all. The biotechnology industry is experiencing rapid technological changes. Failure to anticipate technology innovations or adapt to such innovations in a timely manner, or at all, may result in our products becoming obsolete at sudden and unpredictable intervals. If we are unable to adapt to technological changes, we may not be able to effectively compete with other companies and/or product offerings that offer improved technology.

 

Our Business Model is Evolving.

 

Our business model is unproven and is likely to continue to evolve. Accordingly, our initial business model may not be successful and may need to be changed. Our ability to generate significant revenues will depend, in large part, on our ability to successfully market our products to potential users who may not be convinced of the need for our products and services or who may be reluctant to rely upon third parties to develop and provide these products. We intend to continue to develop our business model as our market continues to evolve.

 

If We Fail to Maintain and Enhance Awareness of Our Brand, Our Business and Financial Results Could be Adversely Affected.

 

We believe that maintaining and enhancing awareness of our brand is critical to achieving widespread acceptance and success of our business. We also believe that the importance of brand recognition will increase due to the relatively low barriers to entry in our market. Maintaining and enhancing our brand awareness may require us to spend increasing amounts of money on, and devote greater resources to, advertising, marketing, and other brand-building efforts and these investments may not be successful. Further, even if these efforts are successful, they may not be cost-effective. If we are unable to continuously maintain and enhance our media presence, our market may decrease and we may fail to attract advertisers and subscribers, which could in turn result in lost revenues and adversely affect our business and financial results.

 

An Inability to Maintain and Enhance Product Image Could Harm Our Business.

 

It is important that we maintain and enhance a positive perception of any new products. The image and reputation of our products may be impacted for various reasons including, but not limited to, bad publicity, litigation, and complaints from regulatory bodies. Such problems, even when unsubstantiated, could be harmful to our image and the reputation of our products. These claims may not be covered by our insurance policies. Any resulting litigation could be costly for us, divert management attention, and could result in increased costs of doing business, or otherwise have a material adverse effect on our business, results of operations, and financial condition. Any negative publicity generated could damage our reputation and diminish the value of our brand, which could have a material adverse effect on our business, results of operations, and financial condition. Deterioration in our brand equity (brand image, reputation, and product quality) may have a material adverse effect on our financial results.

 

Our Products and/or Services May Not Gain Market Acceptance.

 

Our products and/or services may not gain market acceptance among physicians, healthcare payors, patients, and the medical community, which are critical to commercial success. Market acceptance of any product or service depends on a number of factors, including:

 

  the efficacy and safety as demonstrated in clinical trials, if required;
     
  the timing of market introduction of such product or service as well as competitive products;
     
  the clinical indications for which the product or service is approved;
     
  acceptance by physicians, hospitals, and patients of the product or service as a viable treatment;
     
  the potential and perceived advantages of such product or service over alternative treatments, especially with respect to patient subsets that we are targeting with such product or service;
     
  the perceived viability of such product or service seen in a broader patient group, including its use outside the approved indications;
     
  the cost of treatment in relation to alternative treatments;
     
  the availability of adequate reimbursement and pricing by third-party payors and government authorities;
     
  the prevalence and severity of adverse side effects; and
     
  the effectiveness of our sales and marketing efforts.

 

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We Will be Reliant on Government Authorities and Third-Party Payors, Such as Private Health Insurers and Health Maintenance Organizations, Who Decide Which Products and Services They Will Pay for and Establish Reimbursement Levels.

 

Government authorities, including the United States Health and Human Services Department (HHS) and, through them, the Centers for Medicare and Medicaid Services (CMS), the various U.S. state equivalents to the Federal organizations, and third-party payors, such as private health insurers and health maintenance organizations, decide which products and services they will pay for and establish reimbursement levels for those products and services to be offered through their networks. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product or service is:

 

  a covered benefit under its health plan;
     
  effective and medically necessary;
     
  appropriate for the specific patient;
     
  cost-effective; and
     
  neither experimental nor investigational.

 

Obtaining coverage and reimbursement approval for a product or service from a government or other third-party payor is a time consuming and costly process that could require us to provide supporting scientific, clinical, and cost-effectiveness data for the use of our products to the payor. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. If reimbursement of our future products or services is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to effectively market our products for sale to a market of sufficient size and payment depth and therefore never achieve or sustain profitability.

 

A Data Security Breach Could Expose Us to Liability and Protracted and Costly Litigation, and Could Adversely Affect Our Reputation and Operating Revenues.

 

To the extent that our activities involve the storage and transmission of confidential information, we and/or third-party processors will receive, transmit, and store confidential customer and other information. Encryption software and the other technologies used to provide security for storage, processing, and transmission of confidential customer and other information may not be effective to protect against data security breaches by third parties. The risk of unauthorized circumvention of such security measures has been heightened by advances in computer capabilities and the increasing sophistication of hackers. Improper access to our or these third parties’ systems or databases could result in the theft, publication, deletion, or modification of confidential customer and other information. A data security breach of the systems on which sensitive account information are stored could lead to fraudulent activity involving our products and services, reputational damage, and claims or regulatory actions against us. If we are sued in connection with any data security breach, we could be involved in protracted and costly litigation. If unsuccessful in defending that litigation, we might be forced to pay damages and/or change our business practices or pricing structure, any of which could have a material adverse effect on ‘our operating revenues and profitability. We would also likely have to pay fines, penalties, and/or other assessments imposed as a result of any data security breach.

 

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We Depend on Third-Party Providers for a Reliable Internet Infrastructure and the Failure of these Third Parties, or the Internet in General, for Any Reason Could Significantly Impair Our Ability to Conduct Our Business

 

We may outsource some or all of our online presence and data management to third parties who host the actual servers and provide power and security in multiple data centers in each geographic location. These third-party facilities could require uninterrupted access to the Internet. If the operation of the servers is interrupted for any reason, including natural disaster, financial insolvency of a third-party provider, or malicious electronic intrusion into the data center, our business could be significantly damaged. As has occurred with many Internet-based businesses, we may be subject to “denial-of-service” attacks in which unknown individuals bombard our computer servers with requests for data, thereby degrading the servers’ performance. We cannot be certain we will be successful in quickly identifying and neutralizing these attacks. If either a third-party facility failed, or our ability to access the Internet was interfered with because of the failure of Internet equipment in general or if we become subject to malicious attacks of computer intruders, our business and operating results will be materially adversely affected.

 

3D Printed Organs May Fail Once Transplanted into Patients Causing Serious Injury or Death to the Patients, Leading to Lawsuits and Bad Publicity.

 

Our success is dependent upon our ability to develop a human heart that can be successfully transplanted. Because this has never been done by us or any other person or entity, there are significant risks that a patient may have adverse effects from our efforts. For example, a patient’s body may reject the transplanted organ, a patient may suffer significant health issues as a result of the transplanted organ, and a patient may die if the patient’s body rejects the transplanted organ, the organ fails for any reason, or for other complications of the surgical procedures to transplant the heart. Any or all of these occurrences could lead to lawsuits, regulatory sanctions, bad publicity, and other effects which could have a detrimental effect on us and on your investment.

 

If Product Liability Lawsuits are Brought Against Us, We May Incur Substantial Liabilities and May be Required to Limit Commercialization of Our Products and Services.

 

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products and services. We face an inherent risk of product liability as a result of our products and services. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing, or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products and services. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

  decreased demand for the products and services that we may develop;
     
  injury to our reputation;
     
  withdrawal of clinical trial participants, if required;
     
  initiation of investigations by regulators;
     
  costs to defend the related litigation;
     
  a diversion of management’s time and our resources;
     
  substantial monetary awards to patients or others;
     
  product recalls, withdrawals, marketing, or promotional restrictions;
     
  loss of revenues from product sales; and
     
  the inability to commercialize our products and services.

 

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Our Inability to Obtain and Retain Sufficient Product Liability Insurance at an Acceptable Cost to Protect Against Potential Product Liability Claims Could Prevent or Inhibit the Commercialization of Products and Services we Develop.

 

Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products and services we develop. Although we plan to maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

 

The continued impact of the COVID-19 pandemic and related risks could have a material adverse impact on our research and development programs and financial condition.

 

The degree to which COVID-19 continues to impact our business operations, research and development programs, and financial condition will depend on future developments, including the duration of the outbreak and any resurgences, actions by government authorities to contain the spread of the virus, and when and to what extent normal economic and operating conditions can resume.

 

Changes in the Economy Could Have a Detrimental Impact on our Operations.

 

The world has recently been on ordered quarantines and lockdowns which has already greatly impacted the United States economy as well as the economies of other country. We are unsure of the impact that this will have on our business, but it is expected that these changes in the economic climate will most likely have a detrimental impact on our operations and potential revenue generation for the foreseeable future. It is possible that recessionary pressures, particularly those from the COVID-19 lockdown, and other economic factors (such as declining incomes, future potential rising interest rates, higher unemployment, and tax increases) may decrease the disposable income that customers have available to spend on our products and services and may adversely affect customers’ confidence and willingness to spend. Any of such events or occurrences could have a material adverse effect on our financial results and on your investment.

 

Acts of War or Terrorism May Seriously Harm Our Business.

 

Acts of war, any outbreak or escalation of hostilities between the United States and any foreign power, or acts of terrorism may cause disruption to the U.S. economy or the local economies of the markets in which we operate, cause shortages of building materials, increase costs associated with obtaining building materials, result in building code changes that could increase costs of construction, affect job growth and consumer confidence, or cause economic changes that we cannot anticipate, all of which could reduce demand for our homes and adversely impact our business, prospects, liquidity, financial condition, and results of operations.

 

Risks Related to Our Organization and Structure

 

We are Dependent Upon Our Management, Founders, Key Personnel, and Consultants to Execute Our Business Plan, and Many of Them Will Have Concurrent Responsibilities at Other Companies.

 

Our success is heavily dependent upon the continued active participation of our current executive officers as well as other key personnel and consultants. Many of them will have concurrent responsibilities at other entities. Some of the advisors, scientists, consultants, and others to whom our ultimate success may be reliant have not signed contracts with us and may not ever do so. Loss of the services of one or more of these individuals could have a material adverse effect upon our business, financial condition, or results of operations. Further, our success and achievement of our growth plans depend on our ability to recruit, hire, train, and retain other highly qualified scientific, technical, and managerial personnel. Competition for qualified employees and consultants among companies in the applicable industries is intense, and the loss of any of such persons, or an inability to attract, retain, and motivate any additional highly skilled employees and consultants required for the initiation and expansion of our activities, could have a materially adverse effect on it. The inability to attract and retain the necessary personnel, consultants, and advisors could have a material adverse effect on our business, financial condition, or results of operations.

 

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Although Dependent Upon Certain Key Personnel, We Do Not Have Any Key Man Life Insurance Policies on Some People at the Time of This Offering.

 

We are dependent upon management in order to conduct our operations and execute our business plan and despite having obtained insurance policies for the Chief Medical Officer and the Chief Executive Officer, however, we have not purchased any life insurance policies with respect to any other individuals in the event of their death or disability. Therefore, should any of those key personnel, management, or founders die or become disabled, we will not receive any compensation that would assist with such person’s absence. The loss of such person could negatively affect us and our operations.

 

There are Limitations on the Liability of Our Directors.

 

We provide for the indemnification of directors to the fullest extent permitted by law and, to the extent permitted by such law, eliminate or limit the personal liability of directors for monetary damages for certain breaches of fiduciary duty. Such indemnification may be available for liabilities arising in connection with this prospectus. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, or persons controlling the Company pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

 

We Currently Have Limited Marketing and Limited Sales Organization in Place.

 

We currently have limited marketing and limited sales organization for our products and services. If we are unable to establish sufficient marketing and sales capabilities or enter into agreements with third parties to market and sell our products and services, we may not be able to effectively market and sell our product and services, or generate product revenues.

 

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Concentrated Voting Control Will Limit or Preclude Our Shareholders’ Ability to Influence Corporate Matters, Including the Election of Directors, Any Merger, Consolidation, or Other Major Corporate Transaction Requiring Shareholder Approval, Which May Negatively Impact Your Liquidity and/or Your Gain on Your Investment.

 

As of the date of this prospectus, Steven Morris, our founder, Chief Executive Officer, Secretary. and Chairman of our board of directors, beneficially owned approximately 67.5% of our outstanding shares of common stock. Following the completion of this offering, Mr. Morris is expected to beneficially own approximately 40.4% of our outstanding shares of common stock, or approximately 38.1% if the underwriters exercise in full their overallotment option. As a result, Mr. Morris may be able to control any vote of our shareholders which may be required for the foreseeable future and may negatively impact your investment.

 

We are an “Emerging Growth Company” and, as a Result of the Reduced Disclosure and Governance Requirements Applicable to Emerging Growth Companies, Our Securities May Be Less Attractive to Investors.

 

We are an “emerging growth company,” as defined in the JOBS Act, and we are eligible to take advantage of certain exemptions from various reporting requirements applicable to other public companies but not to emerging growth companies, including, but not limited to, a requirement to present only two years of audited financial statements, an exemption from the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act, reduced disclosure about executive compensation arrangements pursuant to the rules applicable to smaller reporting companies, and no requirement to seek non-binding advisory votes on executive compensation or golden parachute arrangements. We have elected to adopt these reduced disclosure requirements. We could be an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of this offering, although a variety of circumstances could cause us to lose that status earlier.

 

In addition, Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (the “Securities Act”) for complying with new or revised financial accounting standards. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the extended transition period and, as a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates. In choosing to take advantage of the extended transition period, we may later decide otherwise (i.e., “opt in” by complying with the financial accounting standard effective dates applicable to non-emerging growth companies), so long as it complies with the requirements in Sections 107(b)(2) and (3) of the JOBS Act, which is irrevocable.

 

We cannot predict if investors will find our common stock less attractive as a result of our taking advantage of these exemptions. If some investors find our common stock less attractive as a result of our choices, there may be a less active trading market for our common stock and our stock price may be more volatile.

 

As a Result of Becoming a Public Company, We Will Be Obligated to Develop and Maintain Proper and Effective Internal Control Over Financial Reporting. We May Not Complete Our Analysis of Our Internal Control Over Financial Reporting in a Timely Manner, or These Internal Controls May Not Be Determined to Be Effective, Which May Adversely Affect Investor Confidence in Us and, as a Result, the Value of Our Securities.

 

As a public company, we will be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting as of the end of our fiscal year 2022. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting.

 

We previously had an independent audit firm which was not PCAOB registered audit our financial statements for the years ended December 30, 2019 and 2020. In preparation for this offering, we retained L J Soldinger Associates, LLC, a PCAOB-registered accounting firm, to complete audits of our financial statements for our 2021 and 2020 fiscal years. During the re-audit of our financial statements, we discovered errors in our 2019 and 2020 previously issued financial statements included in our Form 1-K originally filed with the SEC on April 28, 2021. We restated those financial statements and amended our Form 1-K to include the restated financial statements and appropriate disclosures.

 

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In addition, our current auditor issued a Material Weakness Letter for the years ending December 31, 2021 and 2020 noting the following material weaknesses

 

  We have failed to adequately invest in our accounting and reporting functions such that we are unable to timely record transactions and reconcile accounts to timely prepare and adequately review financial statements in accordance with U.S. GAAP. Our bookkeeping staff are not retained on a continuous basis and are not involved when decisions are made by management, such that they lack critical time and information in order to properly and timely report on the transactions and events.
  We failed to properly account for equity issuance costs in accordance with U.S. GAAP.
  We failed to properly account for stock-based compensation in accordance with U.S. GAAP.
  We failed to properly account for convertible debt in accordance with U.S. GAAP.
  We failed to record necessary accruals at year end for each of the reporting periods.

 

Since February 2022, we have taken steps to address the internal control deficiencies that contributed to the material weaknesses, including:

 

  Hiring additional experienced finance and accounting personnel with technical accounting experience, supplemented by third-party resources documenting and formally assessing our accounting and financial reporting policies and procedures;
  Assessing significant accounting transactions and other technical accounting and financial reporting issues, preparing accounting memoranda addressing these issues and maintaining these memoranda in our corporate records;
  Improving the compilation processes, documentation, and monitoring of our critical accounting estimates;
  Implementing processes for creating an effective and timely close process; and
  Establishing an audit committee with a chairperson who is a CPA with extensive SEC, internal audit, and reporting experience.

 

The implementation of these measures is ongoing and will require validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial reporting cycles. If we are unsuccessful in remediating the material weaknesses and otherwise establishing and maintaining an effective system of internal control over financial reporting, the reliability of our financial reporting, investor confidence in us and the value of our common stock could be materially adversely affected. We can give no assurance that implementation of our plans will remediate these deficiencies in internal control or that additional material weaknesses in our internal control over financial reporting will not be identified in the future.

 

Effective internal control over financial reporting is necessary for us to provide reliable and timely financial reports and, together with adequate disclosure controls and procedures, are designed to reasonably detect and prevent fraud. Our failure to implement and maintain effective internal control over financial reporting could result in errors in our financial statements that could result in a restatement of our financial statements and could cause us to fail to meet our reporting obligations. In addition, we could become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, which could require additional financial and management resources.

 

During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective. If we are unable to assert that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of our financial reports, which would cause the price of our common stock to decline, and we may be subject to investigation or sanctions by the SEC.

 

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We will be required to disclose changes made in our internal control and procedures on a quarterly basis. However, our independent registered public accounting firm will not be required to report on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act until the later of the year following our first annual report required to be filed with the SEC, or the date we are no longer an “emerging growth company” as defined in the JOBS Act, if we continue to take advantage of the exemptions contained in the JOBS Act. At such time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our controls are documented, designed, or operating. Our remediation efforts may not enable us to avoid a material weakness in the future. To comply with the requirements of being a public company, we may need to undertake various actions, such as implementing new internal controls and procedures and hiring accounting or internal audit staff.

 

We Will Incur Increased Costs as a Result of Being a Public Company.

 

As a public company, we will incur significant legal, accounting, and other expenses that we did not incur as a private company. In addition, rules implemented by the SEC and Nasdaq require changes in corporate governance practices of public companies. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly. We will also incur additional costs associated with our public company reporting requirements. We expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, particularly to serve on our audit committee and compensation committee, or as executive officers.

 

Regulatory and Intellectual Property Risks

 

There are Currently No Definitive Regulatory Requirements on the Sale or Use of 3D Bioprinted Organs.

 

Therapeutic tissues and other regenerative medicine products are subject to an extensive, lengthy, and uncertain regulatory approval process by the FDA and comparable agencies in other countries. The regulation of new products is extensive, and the required process of laboratory testing and human studies is lengthy and expensive. The resource investment of time, staff, and expense to satisfy these regulations will fall on us for the products we are developing. We may not be able to obtain FDA approvals for those products in a timely manner, or at all. We may encounter significant delays or excessive costs in our efforts to secure necessary approvals or licenses. Even if we obtain FDA regulatory approvals, the FDA extensively regulates manufacturing, labeling, distributing, marketing, promotion, and advertising after product approval. Moreover, several of our product development areas may involve relatively new technology and have not been the subject of extensive product testing in humans. The regulatory requirements governing these products and related clinical procedures remain uncertain and the products themselves may be subject to substantial review by the FDA and/or foreign governmental regulatory authorities that could prevent or delay approval of these products and procedures. Regulatory requirements ultimately imposed on our products could limit our ability to test, manufacture and, ultimately, commercialize our products and thereby could adversely affect our financial condition and results of operations.

 

We Believe Our Future Products May be Regulated as Medical Devices Under the FDA. This Type of Regulation Presents Many Risks.

 

We currently do not have any devices regulated by the FDA, but believe that our future products will be regulated under medical device reporting and may be subject to those laws and regulations. The Medical Device Reporting laws and regulations require us to provide information to the FDA on deaths or serious injuries alleged to have been associated with the use of our devices, as well as product malfunctions that likely would cause or contribute to death or serious injury if the malfunction were to recur. In addition, the FDA prohibits an approved device from being marketed for off-label use. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.

 

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The Regulatory Approval Processes of the FDA, Other Regulatory Bodies, and Similar Foreign Authorities Is Lengthy, Time Consuming, and Inherently Unpredictable.

 

We believe our products and services will require FDA and/or other regulatory approval in the future for some or all of our products or services. However, we do not believe that this process will take place for three years. At that time, we will be unsure of what the process will be as there is no definitive process for review and approval of 3D bioprinted devices or tissues. The regulatory approval processes of the FDA, other regulatory bodies, and similar foreign authorities could be lengthy, time consuming, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our products and services, our business will be substantially harmed.

 

Our Revenues Will be Dependent, in Part, Upon the Size of the Markets in the Territories for Which We Gain Regulatory Approval and Have Commercial Rights.

 

We believe our products and services will require FDA and/or other regulatory approval in the future and our revenues will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If the markets for patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of our products or services.

 

Our Products and Services Will Require Regulatory Approval in Countries Outside of the United States.

 

We believe our products and services will require FDA and/or other regulatory approval in the future as well as regulatory approval in countries outside of the United States. We must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, possibly clinical trials and commercial sales, pricing, and distribution of our product candidates, and we cannot predict success in these jurisdictions.

 

Our Products and Services Could Fail to Receive Regulatory Approval for Many Reasons.

 

The time required to obtain approval by the FDA, other regulatory bodies, and comparable foreign authorities is unpredictable but could take many years following commencement of clinical trials, depending upon numerous factors. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development. Our products and services could fail to receive regulatory approval for many reasons, including the following:

 

  the FDA, other regulatory body or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials, if any are required;
     
  we may be unable to demonstrate to the satisfaction of the FDA, other regulatory body, or comparable foreign regulatory authorities that a product or service is safe and effective for its proposed indication;
     
  the results of clinical trials, if any are required, may not meet the level of statistical significance required by the FDA, other regulatory body, or comparable foreign regulatory authorities for approval;
     
  we may be unable to demonstrate that a product or service’s clinical and other benefits outweigh its safety risks;
     
  the FDA, other regulatory body, or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials, if any are required;
     
  the FDA, other regulatory body, or comparable foreign regulatory authorities may fail to approve 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, other regulatory body, or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

 

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Undesirable Side Effects Caused by Our Products or Services Could Cause Us or Regulatory Authorities to Interrupt, Delay, or Halt Clinical Trials and Could Result in the Delay or Denial of Regulatory Approval.

 

Undesirable side effects caused by our products or services could cause us or regulatory authorities to interrupt, delay, or halt clinical trials and could result in the delay or denial of regulatory approval by the FDA, other regulatory body, or other comparable foreign authorities. Additionally, if one or more of our products or services receives approval, and we or others later identify undesirable side effects caused by such products or services, a number of potentially significant negative consequences could result, including:

 

  regulatory authorities may withdraw approvals of such products or services;
     
  we may be required to create a guide outlining the risks of such side effects for distribution to patients;
     
  we could be sued and held liable for harm caused to patients; and
     
  our reputation may suffer.

 

Any of these occurrences may harm our business, financial condition, and prospects significantly.

 

The FDA, Other Regulatory Bodies, and Other Comparable Foreign Regulatory Authorities Each Have Substantial Discretion in the Approval Process and May Either Refuse to Consider Our Application for Review or May Form the Opinion After Review of Our Data that Our Application Is Insufficient to Allow Approval of Our Products or Services.

 

The FDA, other regulatory bodies, and other comparable foreign regulatory authorities each have substantial discretion in the approval process and may either refuse to consider our application for review or may form the opinion after review of our data that our application is insufficient to allow approval of our products or services. If, in the future, we decide to pursue commercializing our product in foreign countries, we will have to go through the approval procedures of those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States. Moreover, any approvals that we obtain may not cover all of the clinical indications for which we are seeking approval, or could contain significant limitations in the form of narrow indications, warnings, precautions, or contraindications with respect to conditions of use. In such an event, our ability to generate revenues from such products would be greatly reduced and our business would be harmed.

 

Regulatory Approval to Market a Product or Service May be Subject to Limitations on the Indicated Uses for Which We May Market the Product or Service.

 

We believe our products and services will require FDA and/or other regulatory approval in the future. Even if we do receive regulatory approval to market a product or service, any such approval may be subject to limitations on the indicated uses for which we may market the product or service. It is possible that none of our existing products or services we may seek to develop in the future will ever obtain the appropriate regulatory approvals necessary for us to commence product sales. In many countries outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that country. In some cases, the price that we intend to charge for our products or services is also subject to approval. Any delay in obtaining, or an inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates, generating revenues, and achieving and sustaining profitability.

 

Even if We Receive Regulatory Approval for Any of Our Products or Services, We Will be Subject to Ongoing Obligations and Continued Regulatory Review, Which May Result in Significant Additional Expense.

 

We believe our products and services will require FDA and/or other regulatory approval in the future for some or all of our products or services. Even if we receive regulatory approval for any of our products or services, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our products and services, if approved, could be subject to restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products or services.

 

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If We are 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 Market Approval.

 

The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our products or services. 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 market approval that we may have obtained, which would adversely affect our business, prospects, and ability to achieve or sustain profitability.

 

Legislative and Regulatory Changes to the Healthcare System Could Impact Our Ability to Sell Our Products or Services Profitably.

 

In both the United States and certain foreign jurisdictions, there have been and we expect there will continue to be a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell our products or services profitably. There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may adversely affect:

 

  the demand for any products or services for which we may market and/or obtain regulatory approval, if required;
     
  our ability to set a price that we believe is fair for our products and services;
     
  our ability to generate revenues and achieve or maintain profitability;
     
  the level of taxes that we are required to pay; and
     
  the availability of capital.

 

In addition, governments may impose price controls, which may adversely affect our future profitability.

 

Our Employees 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.

 

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include, but is not limited to, intentional failures to comply with FDA or other regulatory regulations that may apply, provide accurate information to the FDA or other regulatory agencies, comply with manufacturing standards we have established, comply with federal and state health-care fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing, and business arrangements in the healthcare and biotechnology industry are subject to extensive laws and regulations intended to prevent fraud, 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. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, 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 be in compliance with such laws or regulations. 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 fines or other sanctions.

 

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If We are Unable to Effectively Protect Our Intellectual Property, it May Impair Our Ability to Compete.

 

Our success will depend on our ability to obtain and maintain meaningful intellectual property protection for any such intellectual property. The names and/or logos of other company brands may be challenged by holders of trademarks who file opposition notices, or otherwise contest, our trademark applications for our brands. Similarly, domains owned and used by us may be challenged by others who contest our ability to use the domain name or URL. Our business depends on proprietary technology that may be infringed. Some or all of our products depend or will depend on our proprietary technology for its success. We rely on a combination of trade secrets, copyrights, and trademarks, together with non-disclosure agreements, confidentiality provisions in sales, procurement, employment, and other agreements and technical measures to establish and protect proprietary rights in our products. While we may seek patents for some or all of our products and technology, there is no guarantee that such patents will be granted. Our ability to successfully protect our technology may be limited because intellectual property laws in certain jurisdictions may be relatively ineffective, detecting infringements and enforcing proprietary rights may divert management’s attention and company resources, contractual measures such as non-disclosure agreements and confidentiality provisions may afford only limited protection, any patents we may receive will expire, thus providing competitors access to the applicable technology, competitors may independently develop products that are substantially equivalent or superior to our products or circumvent our intellectual property rights; and competitors may register patents in technologies relevant to our business areas. In addition, various parties may assert infringement claims against us. The cost of defending against infringement claims could be significant, regardless of whether the claims are valid. If we are not successful in defending such claims, we may be prevented from the use or sale of certain of our products, or liable for damages and required to obtain licenses, which may not be available on reasonable terms, any of which may have a material adverse impact on our business, results of operation or financial condition.

 

We Rely in Part Upon Trade Secret Protection to Protect Our Intellectual Property; it May be Difficult and Costly to Protect Our Proprietary Rights and We May Not be Able to Ensure its Protection

 

We currently rely in part on trade secrets. While we use reasonable efforts to protect these trade secrets, we cannot assure that our employees, consultants, contractors, or advisors will not, unintentionally or willfully, disclose our trade secrets to competitors or other third parties. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods, and know-how. If we are unable to defend our trade secrets from others use, or if our competitors develop equivalent knowledge, it could have a material adverse effect on our business. Any infringement of our proprietary rights could result in significant litigation costs, and any failure to adequately protect our proprietary rights could result in our competitors offering similar products, potentially resulting in loss of a competitive advantage and decreased revenue. Existing patent, copyright, trademark, and trade secret laws afford only limited protection. In addition, the laws of some foreign countries do not protect our proprietary rights to the same extent as do the laws of the United States. Therefore, we may not be able to protect our proprietary rights against unauthorized third-party use. Enforcing a claim that a third party illegally obtained and is using our trade secrets could be expensive and time consuming, and the outcome of such a claim is unpredictable. Litigation may be necessary in the future to enforce our intellectual property rights, to protect our trade secrets or to determine the validity and scope of the proprietary rights of others. This litigation could result in substantial costs and diversion of resources and could materially adversely affect our future operating results.

 

Risks Related to this Offering and Ownership of our Securities

 

An Investment in Our Securities is Speculative and Could Result in a Loss of Your Entire Investment.

 

An investment in our securities is speculative and involves a high degree of risk. There is no assurance that investors will obtain any return on their investment. You should not purchase the securities if you cannot afford the loss of your entire investment.

 

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There is Currently No Public Market for Our Securities, A Trading Market for Our Securities May Never Develop Following this Offering, and the Price of Our Securities May be Volatile and Could Decline Substantially Following this Offering.

 

There is currently no public market for our securities. We have applied to list our common stock and Warrants on the Nasdaq Capital Market under the symbols “SAVU” and “SAVUW,” respectively. Even if we do list our securities on Nasdaq, an active trading market for our securities may never develop or if one develops, it may not be sustained following this offering. Accordingly, no assurance can be given as to the following:

 

  the likelihood that an active trading market for our securities will develop or be sustained;
     
  the liquidity of any such market;
     
  the ability of our shareholders to sell their shares of common stock or Warrants; or
     
  the price that our shareholders may obtain for their common stock or Warrants.

 

If an active market for our securities does not develop or is not maintained, the market price of our securities may decline, and you may not be able to sell your shares. Even if an active trading market develops for our securities subsequent to this offering, the market price of our securities may be highly volatile and subject to wide fluctuations. Our financial performance, government regulatory action, tax laws, interest rates, and market conditions in general could have a significant impact on the future market price of our securities.

 

Some of the factors that could negatively affect or result in fluctuations in the market price of our securities include:

 

  actual or anticipated variations in our quarterly operating results;
     
  changes in market valuations of similar companies;
     
  adverse market reaction to the level of our indebtedness;
     
  additions or departures of key personnel;
     
  actions by shareholders;
     
  speculation in the press or investment community;
     
  general market, economic, and political conditions, including an economic slowdown or dislocation in the global credit markets;
     
  our operating performance and the performance of other similar companies;
     
  changes in accounting principles; and
     
  passage of legislation or other regulatory developments that adversely affect us or the biotechnology industry.

 

Even if we are successful in listing our common stock and Warrants on Nasdaq, failure to maintain our Nasdaq listing could limit investors’ ability to make transactions in our common stock and Warrants and subject us to additional trading restrictions.

 

We may not be able to meet the continued listing requirements for our common stock and Warrants in the future. Failure to meet the continued listing requirements could result in Nasdaq delisting our common stock from trading on its exchange. If this should happen, we could face significant material adverse consequences, including:

 

  a limited availability of market quotations for our securities;

 

  a limited amount of news and analyst coverage for us; and
     
  a decreased ability to issue additional securities or obtain additional financing in the future.

 

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If our common stock were delisted and determined to be a “penny stock,” a broker-dealer may find it more difficult to trade our common stock and an investor may find it more difficult to acquire or dispose of our common stock in the secondary market.

 

If our common stock were removed from listing with Nasdaq, it may be subject to the so-called “penny stock” rules. The SEC has adopted regulations that define a “penny stock” to be any equity security that has a market price per share of less than $5.00, subject to certain exceptions, such as any securities listed on a national securities exchange. For any transaction involving a “penny stock,” unless exempt, the rules impose additional sales practice requirements on broker-dealers, subject to certain exceptions. If our common stock were delisted and determined to be a “penny stock,” a broker-dealer may find it more difficult to trade our common stock and an investor may find it more difficult to acquire or dispose of our common stock on the secondary market. Investors in penny stocks should be prepared for the possibility that they may lose their whole investment.

 

The Offering Price Per Share of the Securities Offered Under This Prospectus May Not Accurately Reflect the Value of Your Investment.

 

Prior to this offering, there has been no market for our securities. The offering price per share of our securities offered by this prospectus was negotiated between us and the underwriters. Factors considered in determining the price of our common stock include:

 

  the history and prospects of companies with a similar principal business;
     
  prior offerings of those companies;
     
  our capital structure;
     
  general conditions of the securities markets at the time of this offering; and
     
  other factors we deemed relevant.

 

The offering price may not accurately reflect the value of our securities and may not be realized upon any subsequent disposition of the shares.

 

The Warrants included in the Common Units are expected to be listed on Nasdaq separately upon the pricing of this offering, and may provide investors with an arbitrage opportunity that could adversely affect the trading price of our shares.

 

Because the Common Units will never trade as a unit, and the Warrants are expected to be traded on Nasdaq, investors may be provided with an arbitrage opportunity that could depress the price of our shares. The exercise of any Warrants may dilute the value of shares of common stock.

 

The Warrants are Speculative in Nature.

 

Except as otherwise set forth therein, the Warrants offered in this offering do not confer any rights of share ownership on their holders, such as voting rights, but rather merely represent the right to acquire shares at a fixed price for a limited period of time. Specifically, commencing on the date of issuance, holders of the Warrants may exercise their right to acquire shares and pay an exercise price of $5.95 (based on an assumed public offering price of $6.20 per Common Unit, representing 100% of the public offering price per share of common stock), prior to five years from the date of issuance, after which date any unexercised Warrants will expire and have no further value. There can be no assurance that the market price of our shares will continue to equal or exceed the exercise price of the Warrants offered by this prospectus. In the event that our share price does not exceed the exercise price of such Warrants during the period when such Warrants are exercisable, the Warrants may not have any value.

 

Investors in this Offering Will Experience Immediate and Substantial Dilution.

 

Due to our significant accumulated deficit, investors in this offering will suffer immediate and substantial dilution. Further, investors in this offering will own approximately 40.1% of the then outstanding shares of common stock, but will have paid approximately 71.5% of the total consideration for our outstanding shares. (See “Dilution.”)

 

We May Undertake Additional Equity or Debt Financing That May Dilute the Shares in this Offering.

 

We may undertake further equity or debt financing which may be dilutive to existing shareholders, including you, or result in an issuance of securities whose rights, preferences, and privileges are senior to those of existing shareholders, including you, and also reducing the value of securities subscribed for under this offering.

 

We May Not be Able to Obtain Additional Financing.

 

We may require additional funds to continue and grow its business. We may not be able to obtain additional financing as needed, on acceptable terms, or at all, which would force us to delay our plans for growth and implementation of our strategy which could seriously harm our business, financial condition, and results of operations. If we need additional funds, we may seek to obtain them primarily through additional equity or debt financings. Those additional financings could result in dilution to our current shareholders and to you if you invest in this offering.

 

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If Securities Analysts Do Not Publish Research or Reports About Our Business, or If They Downgrade Our Common Stock, the Price of Our Securities Could Decline.

 

The trading market for our securities could be influenced by any research and reports that securities or industry analysts publish about us or our business. We do not currently have, and may never obtain, research coverage by securities and industry analysts. If no securities or industry analysts commence coverage of us, the trading price for our securities would be negatively impacted. In the event securities or industry analysts cover us and one or more of these analysts downgrade our securities or publish inaccurate or unfavorable research about our business, the price of our securities would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our securities could decrease, which could cause the price of our securities and trading volume to decline.

 

Negative Publicity May Affect Our Business Performance and Could Affect Our Stock Price.

 

Unfavorable media related to our industry, company, brands, marketing, personnel, operations, business performance, or prospects may affect our stock price and the performance of our business, regardless of its accuracy or inaccuracy. Our success in maintaining, extending, and expanding our brand image depends on our ability to adapt to a rapidly changing media environment. Adverse publicity or negative commentary on social media outlets, such as blogs, websites, or newsletters, could hurt operating results, as consumers might avoid brands that receive bad press or negative reviews. Negative publicity may result in a decrease in operating results that could lead to a decline in the price of our common stock and cause you to lose all or a portion of your investment.

 

We Have Not Paid Dividends in the Past and Do Not Expect to Pay Dividends in the Foreseeable Future.

 

We have never paid cash dividends on our securities and do not anticipate paying cash dividends in the foreseeable future. We currently intend to retain our future earnings, if any, to finance the development and expansion of our business. The determination to pay dividends will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in any financing instruments, and such other factors as our board of directors deems relevant in its discretion. Accordingly, you may need to sell your shares of our common stock to realize a return on your investment, and you may not be able to sell your shares at or above the price you paid for them, or at all for an indefinite period of time, except as permitted under the Securities Act and the applicable securities laws of any other jurisdiction.

 

We Have Broad Discretion to Use the Proceeds From this Offering, and Our Investment of Those Proceeds May Not Yield a Favorable Return.

 

Our management has broad discretion to use the proceeds from this offering in ways with which you may not agree. There can be no assurance that management’s use of proceeds generated through this offering will prove optimal or translate into revenue or profitability for us. The failure of our management to apply these funds effectively could result in unfavorable returns. This could harm our business and could cause the market value of our securities to decline. Investors are urged to consult with their attorneys, accountants, and personal investment advisors prior to making any decision to invest in us.

 

Future Sales of Our Common Stock, Other Securities Convertible into Our Common Stock, or Preferred Stock Could Cause the Market Value of Our Common Stock to Decline and Could Result in Dilution of Your Shares.

 

Our board of directors is authorized, without your approval, to cause us to issue additional shares of our common stock or to raise capital through the creation and issuance of preferred stock, other debt securities convertible into common stock, options, Warrants and other rights, on terms and for consideration as our board of directors in its sole discretion may determine. Sales of substantial amounts of our common stock or of preferred stock could cause the market price of our common stock to decrease significantly. We cannot predict the effect, if any, of future sales of our common stock, or the availability of our common stock for future sales, on the value of our common stock. Sales of substantial amounts of our common stock by Steven Morris or another large shareholder, or the perception that such sales could occur, may adversely affect the market price of our common stock.

 

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In addition, in connection with this offering, subject to certain exceptions, each of our officers and directors and the majority of our shareholders has entered into a lock-up agreement that restricts the direct or indirect sale of shares of our common stock beneficially held by such person for 180 days after the date of this prospectus without the prior written consent of the underwriter. In addition, such persons have agreed not to directly or indirectly sell, offer to sell, grant any option, or otherwise transfer or dispose of shares of our common stock for 180 days after the date of this prospectus; provided, however, that such restrictions shall not apply with respect to any of our shareholders (other than our officers, directors, or employees) for the sale of shares of common stock acquired by them in the open market after the completion of this offering. We have agreed not to waive or otherwise modify that agreement without the prior written consent of the underwriter. The underwriter may, at any time, release, or authorize us to release, as the case may be, all or a portion of our common stock subject to the foregoing lock-up provisions. If the restrictions under the lock-up provisions of the lock-up agreements entered into in connection with this offering are waived, shares of our common stock may become available for sale into the market, subject to applicable law, which could reduce the market price for our common stock.

 

We Have Made Assumptions in Our Projections and in Forward-Looking Statements that May Not be Accurate.

 

The discussions and information in this prospectus may contain both historical and “forward-looking statements” which can be identified by the use of forward-looking terminology including the terms “believes,” “anticipates,” “continues,” “expects,” “intends,” “may,” “would,” “should,” or, in each case, their negative or other variations or comparable terminology. You should not place undue reliance on forward-looking statements. These forward-looking statements include matters that are not historical facts. Forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward-looking statements contained in this prospectus based on past trends or activities should not be taken as a representation that such trends or activities will continue in the future. To the extent that the prospectus contains forward-looking statements regarding the financial condition, operating results, business prospects, or any other aspect of our business, please be advised that our actual financial condition, operating results, and business performance may differ materially from that projected or estimated by us. We have attempted to identify, in context, certain of the factors we currently believe may cause actual future experience and results to differ from its current expectations. The differences may be caused by a variety of factors, including but not limited to adverse economic conditions, lack of market acceptance, reduction of consumer demand, unexpected costs and operating deficits, lower sales and revenues than forecast, default on leases or other indebtedness, loss of suppliers, loss of supply, loss of distribution and service contracts, price increases for capital, supplies and materials, inadequate capital, inability to raise capital or financing, failure to obtain customers, loss of customers and failure to obtain new customers, the risk of litigation and administrative proceedings involving us or our employees, loss of government licenses and permits or failure to obtain them, higher than anticipated labor costs, the possible acquisition of new businesses or products that result in operating losses or that do not perform as anticipated, resulting in unanticipated losses, the possible fluctuation and volatility of our operating results and financial condition, adverse publicity and news coverage, inability to carry out marketing and sales plans, loss of key executives, changes in interest rates, inflationary factors, and other specific risks that may be referred to in this prospectus or in other reports issued by us or by third-party publishers.

 

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CAUTIONARY NOTE CONCERNING FORWARD-LOOKING STATEMENTS

 

Various statements contained in this prospectus, including those that express a belief, expectation, or intention, as well as those that are not statements of historical fact, are forward-looking statements. These forward-looking statements may include projections and estimates concerning the timing and success of specific projects and our future production, revenues, income, and capital spending. Our forward-looking statements are generally accompanied by words such as “estimate,” “project,” “predict,” “believe,” “expect,” “intend,” “anticipate,” “potential,” “plan,” “goal,” or other words that convey the uncertainty of future events or outcomes. The forward-looking statements in this prospectus speak only as of the date of this prospectus, and we disclaim any obligation to update these statements unless required by law, and we caution you not to rely on them unduly. We have based these forward-looking statements on our current expectations and assumptions about future events. While our management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory, and other risks, contingencies, and uncertainties, most of which are difficult to predict and many of which are beyond our control. The following factors, among others, may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements:

 

  the timing of receipt of regulatory approvals;
     
  economic changes either nationally or in the markets in which we operate, including declines in employment, volatility of mortgage interest rates, and inflation;
     
  downturn in the biotechnology industry;
     
  changes in assumptions used to make industry forecasts;
     
  continued volatility and uncertainty in the credit markets and broader financial markets;
     
  our future operating results and financial condition;
     
  our business operations;
     
  changes in our business and investment strategy;
     
  availability, terms, and deployment of capital;
     
  changes in, or the failure or inability to comply with, governmental laws and regulations;
     
  the degree and nature of our competition;
     
  our leverage and debt service obligations;
     
  general volatility of the capital markets and the lack of a public market for shares of our securities;
     
  availability of qualified personnel and our ability to retain our key personnel;
     
  our financial performance;
     
  our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act;
     
  our expected use of the proceeds from this offering; and
     
  additional factors discussed under the sections captioned “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Our Business.”

 

These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this prospectus and are subject to risks and uncertainties. We discuss many of these risks in greater detail under “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management 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. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

 

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement of which this prospectus forms a part with the understanding that our actual future results, levels of activity, performance and achievements may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

 

The forward-looking statements made in this prospectus relate only to events as of the date on which such statements are made. We undertake no obligation to update any forward-looking statements after the date of this prospectus or to conform such statements to actual results or revised expectations, except as required by law.

 

25
 

 

USE OF PROCEEDS

 

We expect to receive net proceeds from this offering of approximately $13,314.995 (assuming an initial public offering price of $6.20 per share, which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the underwriting discounts and commissions, non-accountable expense allowance, and the estimated offering expenses of approximately $335,000 payable by us.

 

We estimate that this offering will provide sufficient funds to complete all necessary optimization required for completion of our mini-heart and enable us to fully commercialize it into the market. The funds will be used primarily to scale-up our research operations, in terms of research space, personnel, equipment and consultant support, all of which are essential for us to continue our research and development. We plan to hire additional research staff in the areas of stem cell engineering, biomaterials development, bioprinting, bioreactors and cardiovascular physiology and develop a team-based strategy, where each of our core areas will be headed by a senior scientist and junior level technical support. In addition, we plan to use the funds to expand our research space to accommodate our growth and increase the footprint of the research labs. Funds may also be used to purchase additional equipment to support our ongoing research efforts. We believe that once we are able to commercialize our mini-heart for toxicology testing, we may be able to generate sufficient revenue to support most, if not all, research activities relating to our subsequent commercialization opportunities including cardiac valves, graft, patches, and a full heart viable for transplantation, subject to FDA approval.

 

The underwriters have an option to purchase up to 362,903 additional shares of our common stock and/or 725,806 additional Warrants to purchase common stock within 45 days after the date of this prospectus to cover overallotments, if any, made by the underwriters to investors from whom orders were solicited prior to the date of this prospectus. Exercise of this option in full would result in additional net proceeds to us of approximately $2,249,999. All of such additional net proceeds would be used for raw materials.

 

   Amount   Percentage 
Net proceeds to us(1)   $ 13,314,995     100%
           
Use of proceeds:          
Laboratory Equipment  $4,200,000    31%
Raw Materials  $3,000,000    22%
Laboratory Expenses and Testing  $1,800,000    14%
Selling, General, and Administrative Expenses  $1,300,000    10%
Working Capital  $ 1,335,000     10%
Repayment of Working Capital Loan  $1,100,000    8%
Compliance  $ 579,995     5%
Total    13,314,995     100%

 

  (1) Reflects estimated offering expenses (including non-accountable expense allowance), underwriting discounts and commissions payable by us and assumes no exercise of the underwriter’s option to purchase additional shares of our common stock.

 

Laboratory Equipment: We intend to use $4.2 million of the proceeds of this offering towards capital expenditures towards additional lab equipment. We estimate that we will need approximately $2.2 million for the additional lab equipment for pre-mini heart testing completion and $2 million for equipment post-mini heart testing.

 

Raw Material: We intend to use $3 million to purchase raw materials to build our inventory for the mini-heart.

 

Laboratory Expenses and Testing: We need additional funds in order to fund the buildout of additional lab space, to purchase lab consumables, to pay for the expenses of the mini heart testing, as well as additional research personnel.

 

Selling, General, and Administrative: We intend to use a portion of the proceeds of this offering for additional staff, consultants, and advisors, as well as Intellectual Property research, filings, defense, and security. We will also utilize the funds for our Investor Relations.

 

Working Capital: Expenses for general corporate purposes.

 

Repayment of Working Capital Loan: We intend to use a portion of the proceeds of this offering to satisfy our outstanding $1 million loan pursuant to a Business Loan Agreement and related Promissory Note, made by the Company in favor of Fifth Third Bank, National Association, on May 18, 2022 to fund our working capital needs, as well as to cover any resulting expenses, fees, and accrued interest owed by the BioLife4D – SM Trust under the SM Trust Loan. The Working Capital Loan bears interest at the rate of 4.320% per annum and matures on May 18, 2023 (the “Maturity Date”). We are obligated to make monthly interest payments to the Lender until the Maturity Date upon which date the amount of the entire principal balance and any unpaid but accrued interest is due. (See “Working Capital Loan” under “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”)

 

Compliance: We anticipate that we will have significant additional expenses related to compliance, including for SEC and Nasdaq compliance, compensation of our Board of Directors, Directors and Officers insurance, and auditing compliance.

 

26
 

 

CAPITALIZATION

 

The following table sets forth our capitalization as of the date of this prospectus:

 

  on an actual basis; and
  on a pro forma as adjusted basis to give effect to the sale of our Common Units in this offering, assuming an initial public offering price of $6.20 per Common Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, after the payment of the underwriting discounts and commissions and the estimated offering-related expenses payable by us.

 

This table should be read in conjunction with the sections captioned “Use of Proceeds,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our historical financial statements and related notes thereto included elsewhere in this prospectus.

 

   Actual as of September 30, 2022   Pro Forma As Adjusted(1) 
     
Cash  $304,181   $ 13,619,176  
Debt   1,750,000    

1,750,000

 
Warrant liability (2)        

8,903,223

 
Stockholders’ equity (deficit):          
Common stock, $0.00001 par value, 50,000,000 shares authorized, 3,610,353 outstanding   36    

60

 
Preferred stock, $0.00001 par value, 20,000,000 shares authorized, none outstanding   -    - 
Additional paid-in capital   7,536,127    

11,947,875

 
Accumulated deficit   (9,096,630)   

(9,096,630

)
Total shareholders’ equity   (1,560,467)   

2,851,305

 
Total capitalization  $ 189,533   $

13,504,528

 

 

(1) The pro forma as adjusted information presented is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing. A $1.00 increase (decrease) in the assumed initial public offering price of $6.20 per unit, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total shareholders’ equity, and total capitalization by approximately $2,201,612 assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions. Similarly, each increase (decrease) of 1,000,000 shares in the number of shares offered by us would increase (decrease) our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total shareholders’ equity, and total capitalization by approximately $5,642,000, assuming that the assumed initial public offering price, which is the midpoint of the price range set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions. If the underwriter’s option to purchase additional shares is exercised in full, the pro forma as adjusted amount of each of cash and cash equivalents, additional paid-in capital, total shareholders’ equity, and total capitalization would increase by approximately $2,047,499 after deducting the estimated underwriting discounts and commissions, and we would have shares of our common stock and no shares of our preferred stock issued and outstanding, pro forma as adjusted.
   
(2) We have determined that the fundamental transaction clauses contained within the Warrants and the Underwriter Warrants cause these warrants to be accounted for as liabilities under Accounting Standards Codification (“ASC”) 480- Distinguishing Liabilities from Equity. We engaged independent valuation consultants who utilized an iterated modified BSM put and call model with the following inputs: historical volatility for a basket of similar market size public companies; United States treasury constant maturity auction yields to simulate a risk-free rate; term of the respective warrant, warrant coverage, reset the floor and call pricing, to determine the fair value of the underlying common stock and warrants.

 

The outstanding share information in the table above is based on 3,610,353 shares of our common stock outstanding as of the date of this prospectus, and:

 

  Reflects a one for three reverse split of our common stock, which was effected on August 25, 2022;
  assumes no exercise of the underwriter’s overallotment option;
  excludes up to 120,967 shares of our common stock issuable upon the exercise of the Underwriter’s Warrants to be issued to the underwriter at the closing of this offering;
  assumes no exercise of any Warrants issued in this offering;
  excludes 132,001 shares of our common stock issuable upon the exercise of outstanding options for shares of common stock; and
  excludes that certain number of shares of our common stock issuable upon conversion of $600,000 of principal plus interest outstanding on convertible promissory notes multiplied by 80% of the price per share of the common stock offered hereby, assuming aggregate gross sales of our equity securities of at least $7.5 million from this offering (see Note 5 to the Financial Statements for a description of the convertible notes).

 

(See “Description of Securities.”)

 

27
 

 

DILUTION

 

If you purchase securities in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per share in this offering and the net tangible book value per share of common stock upon completion of this offering.

 

Net tangible book value per share of common stock represents the amount of our total tangible assets less total liabilities, divided by the number of shares of common stock outstanding. Our net tangible book value as of September 30, 2022 was ($1,560,467) or ($0.43) per share of common stock, based upon 3,610,353 shares of common stock outstanding.

 

Investors participating in this offering will incur immediate, substantial dilution. After giving effect to the sale of our securities at the initial public offering price of $6.20 per unit, the midpoint of the estimated initial public offering price range set forth on the cover page of this prospectus and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our net tangible book value as of September 30, 2022 would have been approximately $2,851,305 or approximately $0.47 per share of common stock.

 

This represents an immediate increase in net tangible book value of $0.90 per share to existing common shareholders, and an immediate dilution of $2.05 per share to investors participating in this offering. If the initial public offering price is higher or lower, the dilution to new shareholders will be greater or lower, respectively.

 

The following table illustrates this dilution on a per share basis:

 

Assumed initial offering price per share  $

2.52

 
Historical net tangible book value per share  $ (0.43 )
Pro forma net tangible book value per share as of September 30, 2022  $

0.47

 
Increase in pro forma net tangible book value per share after this offering  $

0.90

 
Pro forma as adjusted net tangible book value per share after this offering  $

0.47

 
Dilution in net tangible book value per share to new investors(1)  $

2.05

 

 

(1) Dilution is determined by subtracting net tangible book value per share after giving effect to this offering from the initial public offering price paid by a new investor.

 

A $1.00 increase (or decrease) in the assumed initial public offering price of $6.20 per unit, which is the midpoint of the estimated initial public offering price range set forth on the cover page of this prospectus, would increase (or decrease) the as adjusted net tangible book value per share after this offering by approximately $0.13 and dilution in net tangible book value per share to new investors by approximately $2.92 assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise in full their option to purchase additional shares of our common stock in this offering, the as adjusted net tangible book value after this offering would be $0.56 per share, the increase in net tangible book value to existing shareholders would be $0.99 per share and the dilution to new investors would be $1.96 per share, in each case assuming an initial public offering price of $6.20 per unit, which is the midpoint of the estimated initial public offering price range set forth on the cover page of this prospectus.

 

The following table summarizes, as of the date of this prospectus, the differences between our existing shareholders and new investors with respect to the number of shares purchased from us, the total consideration paid and the average price per share paid. The calculations with respect to shares purchased by new investors in this offering reflect the initial public offering price of $6.20 per unit, which is the midpoint of the estimated initial public offering price range set forth on the cover page of this prospectus, before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us:

 

   Shares Purchased   Total Consideration   Average Price 
   Number   Percentage   Amount   Percentage   Per Share 
Existing shareholders    3,610,353      59.9 %    5,737,925       28.5 %  $ 1.59  
New investors (1)     2,419,354      40.1 %  $ 14,395,157       71.5 %  $ 5.95  
Total    6,029,707      100 %  $ 20,133,082       100 %  $ 3.34  

 

(1)

Assumed price $5.95 per share (public offering price per Common Unit, less the price per Warrant included within the Common Unit, based on an assumed public offering price of $6.20 per Common Unit, the midpoint of the price range of the Common Units).

 

If the underwriters exercise their overallotment option to purchase additional shares of our common stock in full, our existing shareholders would own 56.6% and our new investors would own 43.5% of the total number of shares of our common stock outstanding following this offering.

 

The outstanding share information in the table above is based on 3,610,353 shares of our common stock outstanding as of the date of this prospectus, and:

 

Reflects a one for three reverse split of our common stock, which was effected on August 25, 2022;
assumes no exercise of the underwriter’s overallotment option to purchase up to an additional 120,967 shares of our common stock and 241,934 Warrants to purchase common stock;
assumes no exercise of any Warrants or Underwriter’s Warrants issued in this offering;
excludes 132,001 shares of our common stock issuable upon the exercise of outstanding options to purchase shares of common stock; and
excludes that certain number of shares of our common stock issuable upon conversion of $600,000 of principal plus interest outstanding on convertible promissory notes multiplied by 80% of the price per share of the common stock offered hereby, assuming aggregate gross sales of our equity securities of at least $7.5 million from this offering (see Note 5 to the Financial Statements for a description of the convertible notes).

 

(See “Description of Securities.”)

 

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DIVIDEND POLICY

 

We currently intend to retain our future earnings, if any, to finance the development and expansion of our business. The determination to pay dividends will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in any financing instruments, and such other factors as our board of directors deems relevant in its sole discretion. Accordingly, you may need to sell your shares of our common stock to realize a return on your investment, and you may not be able to sell your shares at or above the price you paid for them. (See “Risk Factors—Risks Related to this Offering and Ownership of our Common Stock—We currently do not intend to pay dividends on our common stock.”)

 

29
 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis should be read together with our financial statements. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements” for a discussion of the uncertainties, risks, and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this prospectus.

 

General

 

BIOLIFE4D CORPORATION is a pioneering development stage biotech company that plans to leverage current advances in life sciences and cardiac tissue engineering to build human hearts first for cardiotoxicity testing and ultimately potentially suitable for implantation.

 

We plan to strategically position ourselves at the center of an unprecedented convergence of regenerative medicine, stem cell biology, additive manufacturing (3D printing), and computing technology – all having reached a level of maturity where we believe that commercially viable bioprinting solutions can be created through optimization, not invention. It is impossible to predict the exact amount of time it will take to fully optimize this process. We also need to obtain the approval of the FDA and it is impossible to predict the timeframe of the FDA approval process.

 

Since our inception, we have incurred significant operating losses. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of our development stage product. We reported net losses of approximately $2.5 million and $1.3 million for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, we had an accumulated deficit of approximately $9.1 million. We expect to continue to incur significant expenses and increasing operating losses until we have a commercially viable product. We expect that our expenses and capital expenditures will increase substantially in connection with our ongoing activities including, but not limited to the following:

 

Purchase additional lab equipment for our pre-mini heart and post mini-heart testing;
Build out of additional lab space, lab supplies;
Hire additional lab, research, and science personnel;
Add operational, legal, compliance, financial, investor relations, and management information systems personnel, for commercialization efforts and support our operations as a new public company.

 

We will not generate revenue from product sales unless and until we successfully complete our mini heart. If we are successful in developing the mini heart; we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, and distribution. Further, we expect to incur additional costs associated with operating as a public company. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings and debt financings. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of our products.

 

Components of Our Results of Operations

 

Revenue

 

To date, we have not generated any revenue from any sources, including product sales, and do not expect to generate any revenue from the sale of products for the foreseeable future. If our development efforts for our product candidates are successful, we may generate revenue in the future from product sales.

 

Operating Expenses

 

30
 

 

Research and Development Expenses

 

Research and development expenses consist of costs incurred for our research activities, including our discovery efforts and the development of our product candidates. These expenses include salaries and related personnel cost, including stock based compensation, research supplies, rent, independent contractors, and research and development advisory board costs and other costs that directly support our research and development activities.

 

A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any of our product candidates.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, for our executives and other administrative functions. General and administrative expenses include legal fees, accounting, auditing, consulting, and tax services; insurance costs; travel expenses; and facility costs not otherwise included in research and development expenses.

 

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance, and investor and public relations expenses associated with operating as a public company.

 

Other Income (Expense)

 

Loan Forgiveness. Loan forgiveness relates to the Paycheck Protection Program under the CARES Act (“PPP”).

 

Interest Income. Interest income consists of interest earned on our cash balances.

 

Interest Expense. Interest expenses consist of interest on convertible debt and related party debt.

 

Income Taxes

 

Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development tax credits earned in each year and interim period, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.

 

Results of Operations

 

Three Months Ended September 30, 2022 Compared to Three Months Ended September 30, 2021

 

General and Administrative Expenses

 

General and administrative expenses for the three months ended September 30, 2022 were approximately $0.5 million compared to approximately $0.3 million for the three months ended September 30, 2021. The increase of approximately $0.2 million in general and administrative expenses primarily relates to increases in salaries and personnel-related costs along with an increase in professional fees. As we transition to a public company, we expect these costs to increase in future periods.

 

Research and Development Expenses

 

Research and development expenses for the three months ended September 30, 2022 was $0.2 million compared to $0.5 million for the three months ended September 30, 2021. The decline in cost was primarily due to a decrease in stock compensation.

 

Nine Months Ended September 30, 2022 Compared to Nine Months Ended September 30, 2021

 

General and Administrative Expenses

 

General and administrative expenses for the nine months ended September 30, 2022 were approximately $1.7 million compared to approximately $0.8 million for the nine months ended September 30, 2021. The increase of approximately $0.9 million in general and administrative expenses primarily relates to increases in salaries and personnel-related costs along with an increase in professional fees. As we transition to a public company, we expect these costs to increase in future periods.

 

Research and Development Expenses

 

Research and development expenses for the nine months ended September 30, 2022 was $0.7 million compared to $0.7 million for the nine months ended September 30, 2021. We expect these costs to increase in future periods as we accelerate our product development.

 

Liquidity and Capital Resources

 

As indicated in the accompanying unaudited financial statements, we had an accumulated deficit of approximately $9.1 million, incurred a net loss of approximately $2.5 million, and cash outflows from operations of approximately $1.1 million as of and for the nine months ended September 30, 2022. Further, we expect to continue to incur significant costs in the pursuit of our business plans. We cannot assure you that our plans to raise capital or to complete our research and development activities and commercialize our products will be successful. These factors, among others, raise substantial doubt about our ability to continue as a going concern.

 

Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and, if successful, clinical development of our programs. To date, we have funded our operations with proceeds from sales of common stock, PPE loans, and borrowings under convertible promissory notes. As of September 30, 2022, we had cash and cash equivalents of $0.3 million. In January 2022, the holders of $600,000 of outstanding convertible notes were notified that we elected, under provisions contained in the note agreements, to extend the maturity date of the convertible notes until January 2024. The result of this election increased the interest rate under the convertible notes to 12% per annum.

 

Operating Activities

 

During the nine months ended September 30, 2022, operating activities used $1.1 million of cash, primarily resulting from our net loss of approximately $2.5 million, partially offset by non-cash charges and changes in our operating assets and liabilities of $1.4 million.

 

During the nine months ended September 30, 2021, operating activities used approximately $0.8 million of cash, primarily resulting from our net loss of approximately $1.3 million, partially offset by non-cash charges and changes in our operating assets and liabilities of $1.4 million.

 

Financing Activities

 

During the nine months ended September 30, 2022, net cash provided by financing activities was approximately $0.5 million, consisting of $1.0 million working capital loan and partially offset by $0.5 million of costs related to this offering.

 

During the nine months ended September 30, 2021, net cash provided by financing activities was approximately $1.6 million, consisting of net proceeds, after deducting offering costs, from the sale of common stock of approximately $1.4 million and proceeds of approximately $0.2 million from borrowings under the PPP.

 

Results of Operations

 

Year Ended December 31, 2021 Compared to Year Ended December 31, 2020

 

General and Administrative Expenses

 

General and administrative expenses for the year ended December 31, 2021, were approximately $1.0 million, compared to approximately $0.9 million for the year ended December 31, 2020. The increase approximately of $0.1 million in general and administrative expenses primarily relates to increase in salaries and personnel-related costs along with an increase in professional fees.

 

Research and Development Expenses

 

Research and development expenses for the year ended December 31, 2021, were approximately $0.8 million compared to approximately $0.7 million for the year ended December 31, 2020. The increase of approximately $0.1 million in research and development expenses in 2021 from 2020 primarily relates to stock based compensation costs incurred in 2021 offset by reductions in advisory board and employee wages incurred in 2021 as compared to 2020.

 

31
 

 

Other Income (Expense)

 

Loan Forgiveness. In 2021, approximately $0.4 million of PPP loans were forgiven. In 2020, we did not have any loans forgiven.

 

Interest Income. Interest income for the years ended December 31, 2021 and 2020 was minimal and consisted of interest earned on invested cash balances.

 

Other Income (Expense), Net. Interest expense for the years ended December 31, 2021 and 2020 was approximately $0.1 million, and was primarily related to our convertible note.

 

Liquidity and Capital Resources

 

As indicated in the accompanying financial statements, we had an accumulated deficit of approximately $6.6 million, incurred a net loss of approximately $1.5 million and cash outflows from operations of approximately $1.1 million as of and for the year ended December 31, 2021. Further, we expect to continue to incur significant costs in the pursuit of our business plans. We cannot assure you that our plans to raise capital or to complete our research and development activities and commercialize our products will be successful. These factors, among others, raise substantial doubt about our ability to continue as a going concern.

 

Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and, if successful, the clinical development of our programs. To date, we have funded our operations with proceeds from sales of common stock and borrowings under convertible promissory notes. As of December 31, 2021, we had cash and cash equivalents of $0.9 million. In January 2022, the holders of $600,000 of outstanding convertible notes were notified that we elected, under provisions contained in the note agreements, to extend the maturity date of the convertible notes until January 2024. The result of this election increased the interest rate under the convertible notes to 12% per annum.

 

Operating Activities

 

During the year ended December 31, 2021, operating activities used $1.1 million of cash, primarily resulting from our net loss of approximately $1.5 million, partially offset by non-cash charges of approximately $0.3 million and net cash provided by changes in our operating assets and liabilities of $0.1 million.

 

During the year ended December 31, 2020, operating activities used approximately $1.5 million of cash, primarily resulting from our net loss of approximately $1.7 million, partially offset by non-cash charges of approximately $0.3 million.

 

Financing Activities

 

During the year ended December 31, 2021, net cash provided by financing activities was approximately $1.7 million, consisting of net proceeds from the sale of common stock of approximately $1.6 million and proceeds of approximately $0.2 million from PPP borrowings.

 

During the year ended December 31, 2020, net cash provided by financing activities was approximately $0.5 million, consisting of net proceeds, after deducting offering costs, from the sale of common stock of approximately $0.5 million and proceeds of approximately $0.2 million from PPP borrowings. This was partially offset by a repayment of approximately $0.3 million shareholder loan.

 

Funding Requirements

 

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance our research and development to create a mini heart. In addition, transition from a private company to a publicly-traded company will increase our reporting and compliance cost.

 

32
 

 

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings and debt financings. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of such stockholders. 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 acquisitions or capital expenditures, or declaring dividends.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

 

While our significant accounting policies are described in more detail in Note 2 to our financial statements, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

 

Stock-Based Compensation

 

The Financial Accounting Statements Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718, Compensation - Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions in which employee services are acquired. We recognize compensation cost relating to stock-based payment transactions using a fair-value measurement method, which requires all stock-based payments to employees, including grants of employee stock options, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. We determine the fair value of stock-based option awards, that do not contain any provisions which would result in liability classification, using the Black-Scholes-Merton option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, and expected life of the options. For awards with performance-based vesting criteria, we estimate the probability of achievement of the performance criteria and recognizes compensation expense related to those awards expected to vest. We account for forfeited awards as they occur. Ultimately, the actual expenses recognized over the vesting period will be for those shares that vested. Our common stock price is assessed using valuation methods in accordance with the American Institute of Certified Public Accountants’ Valuation of Privately-Held-Company Equity Securities Issued as Compensation practice guide. These estimates represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.

 

We have adopted the guidance included under Accounting Standards Update (“ASU”) ASU 2018-17, stock-based compensation issued to non-employees and consultants on January 1, 2018. Equity-based payments to non-employees are measured at grant-date fair value of equity instruments that we are obligated to issue when the service has been rendered and any other conditions necessary to earn the rights to benefit from the instruments have been satisfied. Equity-classified nonemployee share based payment awards are measured at the grant date.

 

Research and Development Costs

 

Costs incurred in connection with research and development activities are expensed as incurred. These costs include rents for facilities, supplies, and other fees related to our research efforts, fees paid to consultants that perform certain research and testing on our behalf, and costs related to salaries, benefits, bonuses, and stock-based compensation granted to employees in research and development functions.

 

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Off-Balance Sheet Arrangements

 

During the periods presented, we did not have and we do not currently have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

 

Implications of Being an Emerging Growth Company

 

We are an “emerging growth company,” as defined in the JOBS Act, and we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies.” These provisions include:

 

  a requirement to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in an initial public offering registration statement;
  an exemption to provide fewer than five years of selected financial data in an initial public offering registration statement;
  an exemption from the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act in the assessment of the emerging growth company’s internal control over financial reporting;
  an exemption from the adoption of new or revised financial accounting standards until they would apply to private companies; and
  an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer.

 

We have elected to adopt the reduced disclosure requirements available to emerging growth companies. As a result of this election, the information that we provide in this prospectus may be different than the information you may receive from other public companies in which you hold equity interests.

 

We would cease to be an “emerging growth company” upon the earliest of: (i) the end of the fiscal year following the fifth anniversary of this offering, (ii) the first fiscal year after our annual gross revenues are $1.235 billion or more, (iii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt securities or (iv) as of the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million as of the end of the second quarter of that fiscal year.

 

Working Capital Loan

 

On May 18, 2022, we borrowed $1 million to fund our working capital needs pursuant to a Business Loan Agreement by and between us, as the borrower, and Fifth Third Bank, National Association, as lender (the “Lender”) and a related Promissory Note, made by us in favor of the Lender, each dated as of May 18, 2022 (the “Working Capital Loan”). The Promissory Note has an interest rate of 4.320% and matures on May 18, 2023 (the “Maturity Date”). We are obligated to make monthly interest payments to the Lender until the Maturity Date upon which date the amount of the entire principal balance and any unpaid but accrued interest is due. Our obligations under the Working Capital Loan are secured by a lien on a certain deposit account with the Lender (the “Deposit Account”) owned by the BioLife4D – SM Trust dated November 1, 2016, (the “BioLife4D – SM Trust”) pursuant to an Assignment of Deposit Account, dated as of May 18, 2022, by and among the BioLife4D – SM Trust, us, and the Lender.

 

The Deposit Account was funded by the BioLife4D – SM Trust, our CEO’s trust, through its receipt of a $1 million loan from one of our minor shareholders (the “SM Trust Loan”), pursuant to a Secured Promissory Note, dated as of May 18, 2022, made by the BioLife4D – SM Trust in favor of the shareholder, in the principal amount of $1 million (the “Secured Promissory Note”). The SM Trust Loan is secured by a pledge by the BioLife4D – SM Trust of 33,334 shares of our common stock pursuant to a Stock Pledge Agreement, dated as of May 18, 2022, by and between the BioLife4D – SM Trust, as pledgor, and the shareholder, as secured party (the “Stock Pledge Agreement”).

 

We intend to use a portion of the proceeds from this offering to repay the Working Capital Loan in full, as well as to pay the BioLife4D – SM Trust any accrued principal, interest, expenses, or fees owed by the BioLife4D – SM Trust under the SM Trust Loan that remain outstanding after the release of the funds from the Deposit Account back to the shareholder.

 

The above summary of our Working Capital Loan and the SM Trust Loan is qualified in its entirety by reference to the full text of the Business Loan Agreement and the related Promissory Note and Assignment of Deposit Account, with respect to the Working Capital Loan, and the Secured Promissory Note and Stock Pledge Agreement, with respect to the SM Trust Loan, which are filed as exhibits to the registration statement of which this prospectus forms a part.

 

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OUR BUSINESS

 

Our Origins

 

After several years of extensive research into the specific processes and technologies of the evolving 3D bioprinting and regenerative medicine fields, medical manufacturing industry veteran Steven Morris recognized the potential of this emerging market. This research, along with more than 15 years of extensive hands-on experience in the medical field, led to the formation of BIOLIFE4D in 2016, a regenerative medicine 3D bioprinting company, whose goal is to facilitate the biological printing of viable human organs, beginning with a heart, for utilization in cardiotoxicity testing and ultimately, if FDA approval is obtained, patient-specific human transplantation. In plain terms, our mission is to make human heart replacement affordable and accessible– saving lives and giving mankind the gift of time.

 

We plan to continue to leverage and optimize what we believe is the best research and technology available to us, capitalize on new advancements in digital capabilities, and bring together highly experienced industry specialists in an innovative and creative way to drive a single shared vision to revolutionize medical care for the benefit of all humanity.

 

We have established a scientific advisory board with specific experience in life-sciences, biomedical engineering, and tissue engineering and we have also engaged specialists in mechanical engineering, software technologies, and applications engineering. (See biographies of our Scientific Advisory Board in “Management.”)

 

Preliminary Milestones

 

In June 2018, we announced the achievement of our first initial milestone, the proof of concept for our cardiac patch. The significance of the cardiac patch was, among other things, a validation that we were able to deploy the process central to our technology, namely taking human specialized cells (i.e., mono-nuclear blood cells) and reprogramming them into induced adult stem cells (induced pluripotent stem cells or “iPS”); and then reprogramming them again (differentiation) into the specialized cells which make up the human heart (i.e., cardiomyocytes, etc.); and then putting those cells into a specially formulated “bioink” creating the 3D aqueous environment similar to that which is found inside the human body; and then using the bioink to 3D bioprint living human cardiac tissue.

 

Immediately thereafter, we turned our focus on the “mini-heart,” a scaled-down version of a human heart bioengineered using essentially the same process as the cardiac patch. Upon commercialization, the mini-heart could be significant in two ways: first, we would be able to announce to the world that a human organ (albeit a scaled down version) was successfully bioengineered and second, it represents a significant short-term path to market for us and our ability to potentially generate revenue.

 

There will be three versions of the mini-heart introduced. It is important to note that for the mini-heart to initially get to the market no FDA approval is required and there is no regulatory path that needs to be followed. This is because the mini-heart is not intended to ever be used in humans and, at least at the onset, will not replace any current FDA requirements for cardiotoxicity testing.

 

The first version of the mini-heart represents our proof of concept and was completed in summer 2019. It enabled us to announce that we achieved this incredible milestone not just for our business, but also for humanity. While this initial version included the major components of the heart, it was not fully functional.

 

The second version of the mini-heart is expected to be released and ready for testing by 2023. After testing is completed, this second version on the mini-heart is planned to be released initially to the domestic U.S. market and then marketed internationally. This second version of the mini-heart will be a refined and further optimized version of the proof of concept and has the purpose of being able to provide pharma better predictive results for cardiotoxicity screening as compared to the current animal model, thus potentially saving this industry billions of dollars in lost research and development (“R&D”) costs and lost time in bringing novel vaccines, drugs and therapies to the point of human clinical trials which had a positive indication in the animal trials but ultimately fail in human trials. While it is critical to note that there is not a required regulatory pathway needed to initially release the mini-heart for commercialization because it will be a test that pharma will use in addition to FDA required protocols, it is our intention to nevertheless work with the FDA utilizing this version of the mini-heart to determine the necessary protocol and testing that the FDA would require to potentially replace their current gold standard animal-based cardiotoxicity model with our mini-heart model.

 

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The third version is planned to be a mini-heart that, instead of representing a healthy human heart model for testing purposes, will have abnormalities bioengineered directly into the mini-heart. The applications for this version are potentially substantial as well, providing a predictive model for people working on therapies for specific abnormalities so they can test their potential therapies on a model which has that specific abnormality.

 

Should we complete protocols established by the FDA to enable the mini-heart to replace the associated animal testing the market would expand geometrically not only in the U.S. but internationally. It is common for other countries regulatory agencies to follow suit with testing practices utilized in the U.S., thus potentially making our mini-heart a global gold standard for cardiotoxicity testing purposes. This said, while we work with the FDA, we also have the opportunity to work with any and all other regulatory agencies around the world in order to have them implement the mini-heart as their standard prior to the FDA approving it as the new standard in the U.S.

 

Currently we are working with the industry to provide the necessary protocols required by pharma in order for them to utilize the mini-heart for their testing purposes. For instance, we will be provided several compounds which tested positive (indicated safe) with the animal model and indeed tested positive (safe) in humans, as well as compounds which tested positive in animals but failed in humans. The positive in animal and positive in human tests provide correlation, the “false positive” is what our mini-heart should be able to provide better predictive results to the industry and could save the industry billions of dollars, and could save countless wasted years chasing therapies which would ultimately fail in humans. There is additional electrophysiology, action potential, contractility, and other parameters currently being established in order to not only satisfy cardiotoxicity indicators but efficacy indicators as well.

 

We have two pending U.S. provisional patent applications:

 

1.U.S. Provisional Patent Application Serial No. 63/342,228, filed May 16, 2022, titled “Methods and Compositions for Organ Printing;” and
2.U.S. Provisional Patent Application Serial No. 63/301,108, filed January 20, 2022, titled “Bioprinting with Cellulose.”

 

Prior to expiration of the provisional patent application for “Methods and Compositions for Organ Printing,” we plan to file a corresponding nonprovisional application for the patent within the 12 month pendency period.

 

Our first provisional patent application was for method to bioprint mini-hearts. We developed a new bioink based on alginate and optimized parameters for the bioprinting of mini-hearts using extrusion based bioprinting. The provisional patent application describes our methods and parameters for extrusion based bioprinting of mini-hearts using an alginate based bioink.

 

Our second provisional patent application was for a bioink based on cellulose. We developed and optimized a new bioink with cellulose as the key component. This provisional patent application describes the composition of the bioink, along with sample prints conducted using this bioink. We believe that this bioink that was developed in our lab will have applications in the production of our mini-hearts for cardiotoxicity testing.

 

A provisional patent application is an initial patent application filed with the U.S. Patent and Trademark Office in order to establish a filing date, but does not begin the patent examination process.  For an invention to be patentable, it must be novel and nonobvious with respect to the prior art. Prior art includes publications, patents, and certain other material that was publicly available before the filing date of a patent application. Thus, by filing a provisional patent application and securing a filing date, the applicant limits the universe of prior art that may otherwise impact the patentability of the invention described in the application. A provisional patent application expires after one year, by which time the applicant needs to continue the patent process by filing a nonprovisional application. The nonprovisional application will be entitled to the benefit of the filing date of the provisional application to the extent that the invention described in the nonprovisional application is also described in the provisional application. In other words, when the nonprovisional application is examined by the U.S. Patent and Trademark Office (or foreign patent offices that similarly recognize the priority filing date of the provisional application), prior art will be limited to those items that were available before the filing date of the provisional patent application - newer art that first became available after the filing date of the provisional patent application would not be available to undermine the patentability of the claimed invention.

 

FDA Timeline Expectations

 

We are not aware of any current FDA regulatory requirements for sale or use of 3D printed organs. GLP data is required in the development of any human therapeutic and we plan to design our technology platform to support compliance with GLPAs. As we move into clinical and commercial settings, full compliance with the FDA’s cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices) guidelines will be required for suitable design and documentation for clinical use of our products. When we do, in fact, attempt to acquire FDA approvals, this process could take many years. While our initial release of our mini-heart is not expected to require FDA approval, each item we bioengineer for human transplantation will require FDA approval and as such shareholders should not expect that we will generate any revenues from those events for at least five years, if not more.

 

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On December 4, 2017, the FDA released a statement regarding its policies related to 3D bioprinting. The FDA is currently making an effort to provide a comprehensive policy framework to manufacturers and a more efficacious pathway to getting state-of-the-art medical products into the hands of patients and healthcare providers. The FDA also plans to review the regulatory issues related to the bioprinting of biological, cellular, and tissue-based products in order to determine whether additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products. The Center for Biologics Evaluation and Research has recently interacted with more than a half-dozen manufacturers who have expressed interest in using 3D printing in some capacity to produce their medical products.1

 

Compassionate Use Exemption

 

At the appropriate time, after appropriate lab tests and trials regarding animals are complete, we might look to the use of a Compassionate Use Exemption for the fully bioengineered heart. Compassionate Use Exemption may be used when a patient is faced with a serious or life-threatening disease or condition and has no other options. The compassionate use provision may allow us to test our products on patients where their treating physician believes the device will save the life of the patient or if there is no other alternative.

 

The compassionate use provision provides a path to accessing investigational devices that have not received full FDA approval or clearance for patients for whom the treating physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition. There is no guarantee the FDA will provide us this type of clearance as it is traditionally used for devices.

 

Right to Try Act

 

The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018. This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.2

 

The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.

 

An eligible patient is a patient who has:

 

-Been diagnosed with a life-threatening disease or condition;
-Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying); and
-Has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician.

 

An eligible investigational drug is an investigational drug:

 

-For which a Phase 1 clinical trial has been completed;
-That has not been approved or licensed by the FDA for any use;
-For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA; and
-Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA.

 

Medical Devices

 

We believe that our future products will be regulated in the United States similarly as Class III medical devices by the FDA under the Federal Food, Drug and Cosmetic Act. The FDA classifies medical devices into one of three classes based upon controls the FDA considers necessary to reasonably ensure their safety and effectiveness. Class I devices are subject to general controls such as labeling, adherence to good manufacturing practices and maintenance of product complaint records, but are usually exempt from premarket notification requirements. Class II devices are subject to the same general controls and also are subject to special controls such as performance standards and may also require clinical testing prior to approval. Class III devices are subject to the highest level of controls because they are life-sustaining or life-supporting devices. Class III devices require rigorous preclinical and clinical testing prior to their approval and generally require a pre-market approval, or PMA, or a PMA supplement approval by the FDA prior to their sale.

 

 

1 U.S. Food and Drug Administration, Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices, December 4, 2017.

2 U.S. Food and Drug Administration, Right to Try, January 14, 2020.

 

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Manufacturers must file an Investigational Device Exemption, or IDE, application if human clinical studies of a device are required and if the FDA considers investigational use of the device to represent significant risk to the patient. The IDE application must be supported by data, typically including the results of animal and nonclinical laboratory testing of the device. The animal and nonclinical laboratory testing must meet the FDA’s good laboratory practice requirements. If the IDE application is approved by the FDA, human clinical studies may begin at a specific number of investigational sites with a maximum number of patients, as approved by the FDA. The clinical studies must be conducted under the review of an independent institutional review board to ensure the protection of patients’ rights.

 

Generally, upon completion of these human clinical studies, a manufacturer seeks approval of a Class III medical device from the FDA by submitting a PMA or PMA supplement application. A PMA application must be supported by extensive data, including the results of the clinical studies, as well as testing and literature to establish the safety and effectiveness of the device. PMA approval may be conditioned upon the conduct of certain post-approval studies, such as long-term follow-up studies.

 

As an alternative to the PMA approval process, manufacturers may apply for a Humanitarian Use Device, or HUD, designation and a corresponding HDE. An HUD is a designation for a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. An applicant for an HUD designation must provide documentation that the device meets the criteria of an HUD as well as provide a description of the disease or condition the device is meant to treat, along with proposed indications and the reasons why the device is needed for its intended population. Once an HUD designation is obtained for the device, the device can be submitted for an HDE. An HDE application is similar to an application for a PMA, but is exempt from the effectiveness requirements of a PMA. Instead, the FDA must determine that the device does not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. “Reasonably obtainable” clinical data are required to support an HDE application. These data may be obtained from the clinical use of the device for a different HDE-approved indication or from a clinical study of the HUD designated device. If the clinical data are available from the clinical use of the device for a different indication, the HDE can be granted without an IDE. If clinical data are to be obtained from a clinical study of the HUD designated device, an IDE application is required to request approval for the clinical study. When the clinical study is completed, we can submit an HDE application for approval to market the device as an HUD.

 

Obtaining an HDE designation allows the manufacturer to market the device as an HUD up to a maximum of 4,000 patients in the United States per year. However, before a facility is permitted to use an HDE-approved device, other than for emergency use, it must receive approval from its applicable Institutional Review Board, or IRB. This could limit the number of patients eligible to receive an HDE-approved device each year. The device manufacturer is responsible for ensuring that an HDE-approved device is administered only in facilities having an IRB constituted and acting in accordance with the FDA’s regulations governing IRBs, including continuing review of use of the device.

 

Also, unless an HDE-approved device satisfies certain eligibility criteria, it cannot be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. In order to be sold at a price in excess of these costs, the HDE-approved device must satisfy one of the following criteria, which we refer to as the HDE Eligibility Criteria:

 

  The device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or

 

  The device is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients, or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.

 

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We believe that FDA regulations will require us to register as a medical device manufacturer with the FDA. Because of this, the FDA will most likely inspect us on a routine basis for compliance with the Quality System Regulation, or QSR. These regulations require that we manufacture our products and maintain related documentation in a prescribed manner with respect to manufacturing, testing and control activities. We have undergone and expect to continue to undergo regular QSR inspections in connection with the manufacture of our products at our facility. Further, the FDA most likely will require us to comply with various FDA regulations regarding labeling. Failure by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions:

 

  warning letters, fines, injunctions, consent decrees and civil penalties;

 

  customer notifications, recall or seizure of our products;

 

  operating restrictions, partial suspension, or total shutdown of production;

 

  delay in processing applications for new products or modifications to existing products;

 

  mandatory product recalls;

 

  withdrawing approvals that have already been granted; or

 

  criminal prosecution.

 

The Medical Device Reporting laws and regulations require us to provide information to the FDA on deaths or serious injuries alleged to have been associated with the use of our devices, as well as product malfunctions that likely would cause or contribute to death or serious injury if the malfunction were to recur. In addition, the FDA prohibits an approved device from being marketed for off-label use. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.

 

We will also be subject to other federal, state, and local laws, regulations, and recommendations relating to safe working conditions, laboratory, and manufacturing practices.

 

Market Drivers

 

Cardiovascular disease is the leading underlying cause of death in the U.S.3 and accounts for about one-third of all deaths worldwide.4 In the U.S. alone, heart disease claims more than 659,000 lives every year.4 And only around 5,000 cardiac transplants occur worldwide every year.5 Heart disease is the leading cause of death for both men and women globally.6 In fact, cardiovascular diseases surpass the annual mortality rate of all types of cancer combined.7 Just in the U.S., one person dies of a heart disease-related event every 36 seconds.8 In China, cardiovascular disease claims a life every ten seconds.9 In 2030, the global cost of cardiac disease is set to rise to $818 billion.10 This includes the cost of healthcare services, medicines, and lost productivity due to death. This is a global problem.

 

 

3 Mortality in the United States, 2020, NCHS Data Brief No. 427, December 2021.

4 Gregory Roth, CVD Causes One-Third of Deaths Worldwide Study Examines Global Burden of CVD: American College of Cardiology, May 2017.

5 Taylor DO, Edwards LB, Boucek MM, et al. Registry of the International Society for Heart and Lung Transplantation: twenty-fourth official adult heart transplant report--2007. J Heart Lung Transplant 2007; 26:769.

6 World Health Organization, Cardiovascular Diseases, June 11, 2021.

7 Weir HK, Anderson RN, Coleman King SM, Soman A, Thompson TD, Hong Y, et al. Heart Disease and Cancer Deaths — Trends and Projections in the United States, 1969–2020. Prev Chronic Dis 2016;13:160211.

8 Mozafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics – 2019 Update: a report from the American Heart Association. Circulation. 2019;139:e56-e528. doi: 10.1161/CIR.0000000000000659.

9 European Society of Cardiology. “One CVD death in China every 10 seconds.” ScienceDaily, October 11, 2012.

10 Go A Mozaffarian D, Roger V, Benjamin E, et al. Executive Summary: Heart disease and stroke statistics—2014 update. Circulation. 2014; 129: e28-e292.

 

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Optimizing a proposed groundbreaking cardiac tissue regeneration and organ replacement process, we plan to address a critical unmet need in the treatment of this devastating disease. While we plan to focus on the human heart, the process may also be leveraged to address numerous other medical challenges.

 

Ultimately, by providing viable tissues and/or organs bioprinted from a patient’s own cells to replace damaged organs, we plan to tap into a global market serving the continually expanding global human population.

 

Current human organ transplant capabilities – with their myriad challenges, high costs and other deficiencies – are ripe for the kind of innovation and process optimization that we look to deliver.

 

The global transplantation market size is expected to reach $19.52 billion by 2028 and the market is anticipated to register a CAGR of 11.5% from 2021 to 2028.10 In the U.S. alone, more than 100,000 people are on an organ transplant waiting list and many others need to be on the list but do not qualify due to disqualifying factors.11 In 2009, 25 people per day died while on the waiting list in the U.S. alone.11

 

And even for those fortunate enough to receive a heart donor transplant, approximately 50% still die within ten years of the transplant. 11 Our proposed process specifically seeks to address this challenge. Medical applications for 3D printing are expanding rapidly and are expected to revolutionize healthcare.12

 

Separate from our primary focus on organ transplants, we could potentially leverage its process to also participate in pharmaceutical discovery and address the need for better predictive tools that pharmaceutical companies can use to more efficiently test drug efficacy and/or toxicity. In 2020, the median capitalized research and development investment to bring a new drug to market was estimated at $985 million and the FDA approved 355 new drugs and biologics from 2009 through 2018.13 In 2019, the pharmaceuticals industry spent $83 billion for research and development drug discovery.14 Human tissues created by our process could make drug compound evaluation faster, more accurate and less risky than conventional testing methods used by pharmaceutical companies.

 

Yet another potentially significant opportunity that our process could provide is an alternative to pharmaceutical testing on animals. The FDA is committed to animal welfare in research by reducing, replacing and/or refining the use of animals in research. The agency is optimistic that cultivating new research approaches can help continue to reduce the need for animal testing.15

 

Competitive Positioning and Value Proposition

 

We are purpose-driven, with leadership that has set its sights on a single shared vision. We continue to assemble a best-in-class team with a history of success, a team we believe can navigate their way along the forefront of an evolution in life-sciences technology, and who can move and pivot quickly without the management bureaucracy or corporate red tape that might prevent some of our competitors from being efficient, innovative, or creative.

 

Standing ready to capitalize on a potentially significant market opportunity, we plan to take advantage of these favorable competitive dynamics for success. We plan to leverage and optimize the best available research and technology to revolutionize medical care through innovation and introduce a potential paradigm shift in three-dimensional patient-specific organ bioprinting.

 

We plan to strategically position ourselves at the center of an unprecedented convergence of regenerative medicine, adult stem cell biology, additive manufacturing, and computing technology – all having reached a level of maturity whereby we are convinced that commercially viable solutions can be created through optimization, not invention.

 

 

10 Polaris Market Research, July 6, 2021 Report.

11 Hertz M, Taylor D, Trulock E, Boucek M, Mohacsi P, Edwards L, et al. The registry of the International Society for Heart and Lung Transplantation: nineteenth official report-2002. J Heart Lung Transplant. 2002; 21:950.

12 Schubert C, van Langeveld MC, Donoso LA. Innovations in 3D printing: a 3D overview from optics to organs. Br J Ophthalmol. 2019;98(2):159–161.

13 RJ Panzo, July 2020; Estimated R&D Cost for New Drug.

14 Congressional Budget Office, Research and Development in the Pharmaceutical Industry, April 2021.

15 U.S. Food and Drug Administration; FDA Statement, Statement by FDA Commissioner Scott Gottlieb, M.D. on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain rials; November 16, 2018.

 

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History documents many examples of commercially viable businesses – even entirely new industries – that were born not from an invention itself, but from the optimization of an evolutionary process. Consider these examples:

 

  In 1901, Ransom Eli Olds invented the assembly line; in 1913, Henry Ford optimized a process that made it commercially viable.
     
  In 1879, David Edward Hughes invented the radio; in 1895, Guglielmo Marconi optimized a process that made it commercially viable.
     
  In 1849, Antonio Meucci invented the telephone; in 1876, Alexander Graham Bell optimized a process that made it commercially viable.
     
  In 1802, Sir Humphry Davy invented the incandescent light; in 1879, Thomas Edison optimized a process that made it commercially viable.
     
  In 1608, Hans Lippershey invented the telescope; in 1609, Galileo Galilei optimized a process that made it commercially viable.

 

Our objective is not to invent new technology, but rather to improve, optimize, adapt, and capitalize on current technologies to create a commercially viable and sustainable process solution.

 

3D Bioprinting Optimized by BIOLIFE4D

 

For years, scientists, engineers, and hobbyists alike have been printing objects using 3D printing devices. The 3D printing industry alone has a projected worth of over $30 billion by 2022.16

 

That technology has more recently been put to use in applications involving living tissue. Today, advancements in regenerative medicine, adult stem cell biology and additive manufacturing have already enabled specialized 3D printing to produce human body parts including multilayered skin, bone, vascular grafts, tracheal splints, heart tissue, and cartilaginous structures – and even simple organs.17

 

By definition, 3D bioprinting is the process of creating cell patterns in a confined space using 3D printing technologies, thereby preserving cell function and viability within the printed construct. 3D bioprinting applies advances in regenerative medicine, adult stem cell biology, additive manufacturing, and computing technology to the development of functional biological structures with the potential to restore, maintain, improve, and/or replace existing organ function. 3D bioprinting is an emerging, groundbreaking strategy in tissue engineering, allowing the fabrication of living constructs with an unprecedented degree of complexity and accuracy.18

 

Everything in the human body is made up of cells, and nature itself has been evolving the capability of programming cells to do specific jobs for millions of years. The human embryo is the best example of this biological manufacturing process. Every cell begins as a stem cell and then is biologically programmed to do a specific job through the natural biologic process inside the body.

 

During the 3D bioprinting process, we plan to replicate the same conditions in vitro (outside of the body) as occur naturally in vivo (within the body) while promoting natural biologic processes in an accelerated timeframe and in a manner that allows the cells to be specialized for a desired purpose.

 

We will not have to make an exact copy or even recreate every feature set of the desired organ; it will only need to facilitate the minimum feature set which recreates the core properties of the organ. It is important to note that we do not believe we need to invent new technology but rather improve, adopt, and optimize current technologies to create what we plan to be a commercially viable and sustainable process.

 

 

16 MarketsandMarkets, “3D Printing Market by Printer Type, Material Type (Metals, Plastics, Ceramics & Others), Material Form (Powder, Liquid, Filament), Process, Technology, Software, Service, Application, Vertical and Geography - Global Forecast to 2022,” April 2016.

17 Nature Biotechnology, “3D bioprinting of tissues and organs,” Sean V Murphy and Anthony Atala, August 5, 2014.

18 Adv Sci (Weinh). 2021 Mar 11;8(10):2003751. doi: 10.1002/advs.202003751.eCollection 2021 May.

 

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Transformative Benefits of 3D Bioprinting Human Tissue

 

Delivering potentially transformative medical benefits, the 3D bioprinting process optimized by us could potentially:

 

  Eliminate rejection of transplant by utilizing patient’s own cells to produce an organ;
     
  Eradicate immunosuppressant therapy requirement (and bad side effects) for the patient;
     
  Provide functionality with capabilities very similar to those in the original organ;
     
  Decrease wait time of patients for human organs;
     
  Minimize need for organ donors;
     
  Increase patient longevity without compromising quality of life;
     
  Potentially eliminate the need for pharmaceutical testing on animals; and
     
  Allow for patient-specific pharmaceutical testing.

 

The Safe Utilization of a Patient’s Own Adult Stem Cells

 

Adult stem cells play a safe, non-controversial and important role in our planned bioprinting process.

 

Because every cell in the human body has the same number of genes and the same DNA, recent discoveries have shown that every cell has the potential to be “re-programmed” and transformed into essentially any other cell. Originally, this kind of stem cell research was limited to cells taken from human embryos, creating a moral and ethical dilemma for many – but no longer. Our process would not involve any embryotic stem cells.

 

In 2006, Japanese Nobel Prize-winning stem cell researcher Dr. Shinya Yamanaka discovered that by introducing a few genes via a chemical procedure in lab, mature adult specialized cells (i.e., blood cells) could be reprogrammed to become adult stem cells.19 This development proved to be a major breakthrough that would spur medical advances such as the 3D bioprinting processes we are developing.

 

Adult stem cells, regardless of their source, have three general properties: they are capable of dividing and renewing themselves; they are unspecialized; and under certain conditions they can become tissue- or organ-specific cells with specialized functions. In short, these adult stem cells could be re-programmed into developing desired specialized cell types such as cardiomyocytes (heart cells). Adult stem cells that are induced in this manner are called induced pluripotent stem cells (iPS).

 

In the planned process, iPS cells will be redirected into organ-specific cells through a process called differentiation which refers to the process by which one type of cell can be changed into different types of specialized cells. After the iPS cells are transformed into the specific organ cells desired, they are monitored to confirm they are the desired organ cell type and further tested to ensure they are viable and safe. These organ-specific cells are then incubated where they continue to divide and multiply in number to make sufficient quantities as needed to create the bio-ink used during the 3D bioprinting process.

 

The disciplines of 3D bioprinting and surgery have witnessed incremental transformations over the last century. 3D bioprinting is a convergence of biology and engineering technologies, mirroring the clinical need to produce viable biological tissue through advancements in printing, regenerative medicine, and materials science.20

 

 

19 Takahashi, K.; Yamanaka, S. (2006), “Induction of Pluripotent Stem Cells from Mouse Embryonic and Adult Fibroblast Cultures by Defined Factors,” Cell, 126 (4): 663–76.

20 Thomas, H.; Front Surg. 2020; 7: 609836. 3D Bioprinting and the Future; Published 2020 Nov 27. doi: 10.3389/fsurg.2020.609836.

 

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High-Level Bioprinted Organ Replacement Process Overview

 

Our proposed bioprinted organ replacement process begins with a magnetic resonance imaging (MRI) test used to create a detailed three-dimensional image of a patient’s original heart. Using this image, a computer software program will construct a digital model of a new heart for the patient, matching the shape and size of the original. Next, doctors safely take cells from the patient via a blood sample, and leveraging recent stem cell research breakthroughs, we plan to reprogram those blood cells and convert them to create specialized heart cells. A “bio-ink” is created using these specialized cells, which is then fed into a 3D bioprinter to print a heart with the dimensions obtained from the MRI. The heart is then matured in a bioreactor, conditioned to make it stronger and readied for patient transplant, subject to the final determination and approval of the FDA and comparable regulatory bodies.

 

Detailed Bioprinted Organ Replacement Process Overview

 

1. An MRI scan would be performed and a blood sample collected from the patient.
   
2. Because every cell in a human body has the same number of genes and the same DNA, every cell has the potential to be converted to essentially any other cell. In the second step of the process, the blood cells from the sample would be converted to unspecialized adult induced pluripotent stem cells (iPS) – cells that can ultimately be changed back into specialized cells of our choice.
   
3. Through a process called differentiation, iPS cells would be converted to almost any type of specialized cell in the human body, in this case cardiomyocytes (heart cells).
   
4. These cells would then be combined with nutrients and other necessary factors in a liquid environment (hydrogel) to keep the cells alive and viable throughout the process. This bio-ink of living cells would be sustained in this aqueous 3D environment.

 

5. The bio-ink would then be loaded into a bioprinter, a highly specialized 3D printer designed to protect the viable living cells during the printing process.
   
6. An appropriately sized heart would then be printed one layer at a time, guided by computer software following the specific dimensions obtained from the MRI. Since the heart cells would not be fused together at this point, a biocompatible and biodegradable scaffolding would be included with each layer to support the cells and hold them in place.
   
7. When the process is complete, the heart would be moved to a bioreactor which would mimic the nutrient and oxygen-rich conditions inside a human body.
   
8. The individual cells would begin self-organizing and fusing into networks which would connect to form living tissue. The cells would even begin to beat in unison.
   
9. Once this process is far enough along, the scaffolding would be dissolved leaving only the fully formed heart.
   
10. A successful patient transplant would then be possible and carried out by a transplant surgeon. Given the original MRI and blood sample, the new heart should be both a perfect fit and a perfect genetic match for the patient – free from the risk of rejection or the need for immunosuppressant therapy that has plagued conventional organ transplant methods.

 

Partnerships and Collaborations

 

In November 2017, we established a core facility partnership with Northwestern University. As part of this core facility partnership, no intellectual property or royalties were or will be transferred to or from any entity. We have not nor will we receive any funding or other monetary support as a result of this core facility partnership. This core facility partnership provides us with access to and use of the core research facilities and equipment at Northwestern University. The core partnership agreement remains in effect until one party provides the other party 20 days advance notice of its intent to terminate the agreement. We will attempt to establish additional research and development agreements with other universities, government backed institutions, hospitals, foundations, and pharmaceutical companies.

 

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Competitive Landscape and Distinctions

 

There are players in the 3D bioprinting industry and adjacent fields, and it is important to make the distinction between what many of these companies do in comparison to our focus.

 

For example, some of the firms listed below tend to focus on creating tissues for pharmaceutical testing. Some focus on building and selling 3D bioprinting hardware devices. Others use 3D printers to create artificial limbs or models of organs.

 

In contrast, our ultimate goal is creating living, viable, fully-formed organs for transplant.

 

Our business and research competitors include the following:

 

  Advanced Solutions Life Sciences (U.S.)
     
  Aspect Biosystems (Canada)
     
  Bio3D Technologies (U.S.)
     
  3D Systems/Allevi (formerly BioBots) (U.S.)
     
  Cyfuse Biomedical K.K. (Japan)
     
  Organovo (U.S.)
     
  Rokit (South Korea)
     
  Novoheart (Canada)
     
  3D Bioprinting Solutions (Russia)
     
  Wake Forest Institute for Regenerative Medicine (U.S.)

 

U.S. Regulatory and Risk Considerations

 

At the time of this filing, bioprinted tissues used in research and education require no U.S. FDA approval during animal and in-vitro (outside of the body) testing. In a 2014 paper entitled “Bioprinting: Organs on Demand,” James S. Gwinn, III discussed risk and safety considerations involving bioprinting while conducting research for a program sponsored by the American Society of Mechanical Engineers.21

 

“The FDA is tasked with evaluating all devices, including any that utilize 3D bioprinting technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used. Safety is paramount at the FDA with somewhat less emphasis placed on form and function. Safety, form, and function are relative terms, though. Over 28,000 times last year, the FDA allowed organ donations because they made the difference between life and death in otherwise terminally-ill patients. The agency allowed these transplants knowing full-well that virtually every organ transplant ever performed would likely fail without a near-constant stream of medication.”

 

Gwinn continued:

 

“Ultimately, the decision that must be made with regard to approving bioprinted organs could boil down to risk versus reward. The first patient-specific organs made via bioprinting may pose substantial risks to the patients. These patients will most likely have exhausted all other options before considering this method of treatment.”

 

 

21 Gwinn III, James S., (August 1, 2014), “Bioprinting: Organs on Demand,” p 14.

 

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Summary of Potential Profit Centers

 

While it is our intention to focus on creating 3D bioprinted organs for life-saving transplants, the associated process could also lend itself to additional revenue streams which could include:

 

  Bioprinted tissues for drug testing and cell based therapies;
     
  Biocompatibility, cytotoxicity, pre-clinical studies, predictive modeling;
     
  Bioprinted tissues for patient-specific drug testing;
     
  Bioprinted tissues for animal-free cosmetic testing;
     
  Bioprinted tissues for regenerative medicine, including tissue replacement products for individualized surgical implantation;
     
  Bioprinting of human organs for specialized testing purposes (usage other than transplants);
     
  Licensing/royalty opportunities;
     
  Bio-ink material;
     
  Bioprinting devices;
     
  Proprietary bioprinting processes; and
     
  Various others.

 

Properties

 

We entered into a month-to-month lease for office space during 2019 in Lincolnshire, Illinois. The lease commitment is for $750 per month.

 

We also have a month-to-month lease for laboratory space in Houston, Texas for $7,298 per month.

 

Seasonality

 

We do not experience seasonal variations in our quarterly operating results and capital requirements.

 

Employees

 

As of the date of this prospectus, we have seven full-time employees, five part-time employees, and eight advisors. None of our employees are members of a labor union or covered by a collective bargaining agreement.

 

Legal Proceedings

 

On August 28, 2020, holders of promissory notes totaling $600,000 filed a lawsuit naming us as a defendant alleging breach of contract in Cook County, Illinois. The file number is 2020L006166. Several of the noteholders’ cases were dismissed with prejudice. As of the date of this prospectus, two noteholders with $375,000 of notes remain in the lawsuit. The matter is still ongoing. Discovery is ongoing. We brought a Motion for Sanctions due to delays against the plaintiffs which was granted and we were awarded attorney’s fees. We have now brought a Second Motion for Sanctions due to further delays by the plaintiffs which is scheduled to be heard on November 17, 2022.

 

Other than the above, we are not party to any legal proceedings the resolution of which we believe would have a material adverse effect on our business, prospects, financial condition, liquidity, or results of operation. However, we may from time to time after the date of this prospectus become subject to claims and litigation arising in the ordinary course of business. One or more unfavorable outcomes in any claim or litigation against us could have a material adverse effect for the period in which such claim or litigation is resolved. In addition, regardless of their merits or their ultimate outcomes, such matters are costly, divert management’s attention, and may materially adversely affect our reputation, even if resolved in our favor.

 

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Accountants

 

On February 7, 2022, our board of directors approved the dismissal of IndigoSpire CPA Group LLC (“Indigo”) as our auditors, effective immediately.

 

Indigo was first engaged by us on November 5, 2019. No audit report of Indigo for the year ended December 31, 2020 and 2021 contained an adverse opinion or a disclaimer of opinion and was not qualified or modified as to uncertainty, audit scope or accounting principles.

 

During our two most recent fiscal years and through the interim period preceding the date of such dismissal, (i) there were no disagreements (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions) between us and Indigo on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure, which, if not resolved to the satisfaction of Indigo would have caused Indigo to make reference to the subject matter of such disagreement in connection with its reports on the financial statements for such periods and (ii) except with respect to the restatement of our audited financial statements as of and for the fiscal years ended December 31, 2020 and 2019, there were no “reportable events” (as defined in Item 304(a)(1)(v) of Regulation S-K).

 

We provided Indigo with a copy of the disclosure contained herein and requested that Indigo furnish a letter stating whether or not it agreed with the statements herein and, if not, stating the respects in which it does not agree. On February 8, 2022, Indigo provided its letter stating it agreed with the statements herein. On February 9, 2022, we disclosed the change in our certifying auditor on Form 1-U filed with the SEC and included a copy of the February 8, 2022 letter received from Indio as an exhibit thereto.

 

Engagement of New Independent Registered Accounting Firm

 

In February 2022, our board of directors approved the appointment of L J Soldinger Associates, LLC (“Soldinger”) as our new independent registered public accounting firm. Prior to adoption by the new board, our sole board member and controlling shareholder, engaged L J Soldinger Associates, LLC in December 2021 to audit our financial statements for the years ended December 31, 2021 and 2020.

 

During our two most recent fiscal years ended December 31, 2021 and 2020, neither we nor anyone acting on our behalf consulted with Soldinger regarding either: (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on our financial statements, in connection with which either a written report or oral advice was provided to the Company that Soldinger concluded was an important factor considered by us in reaching a decision as to the accounting, auditing or financial reporting issue; or (ii) any matter that was either the subject of a disagreement (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions) or reportable event (as defined in Item 304(a)(1)(v) of Regulation S-K).

 

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MANAGEMENT

 

We are managed by our directors and executive officers We also have a Scientific Advisory Board that our management consults with.

 

Directors and Executive Officers

 

Our board of directors consists of three directors. We currently have two independent directors. Our directors will serve for one-year terms and until their successors are duly elected and qualified. There will be no cumulative voting in the election of directors. Consequently, at each annual meeting, the successors to each of our three directors will be elected by a plurality of the votes cast at that meeting.

 

Set forth below are the names, ages and positions of our directors and executive officers as of the date of this prospectus.

 

Name   Age   Position with the Company   Date Joined the Company
Steven Morris   58   Chief Executive Officer, Secretary, and Chairman of our Board of Directors   November 14, 2016
Kate Lewis   60   President   September 15, 2020
Wesley Ramjeet   57   Chief Financial Officer   February 1, 2022
Dr. Jeffrey Morgan   47   Chief Medical Officer   August 23, 2017
Stephen Simes   70   Director   February 4, 2022
Lisa Kelley   55   Director   February 4, 2022

 

Biographical Information

 

Directors and Executive Officers

 

The following is a summary of certain biographical information concerning our current directors and our executive officers.

 

Steven Morris – Chief Executive Officer, Secretary and Chairman of the Board of Directors

 

Steven Morris has more than 20 years of extensive experience in the precision machining and manufacturing industries, including 15 years serving as President of privately-held Inland Midwest Corporation (IMC) from 2000 to 2014. He acquired a controlling interest in IMC and led the company’s transformation into a premier, state-of-the-art facility catering exclusively to the medical technologies industry. By concentrating on strategic process optimization, technical innovation, quality, and customer service, IMC became a preeminent supplier in the industry counting some of the largest U.S. and international medical companies as its customers. The company was marketed as a “boutique” supplier to select industry OEM leaders, including Medtronic Spinal and Biologics, Wright Medical, Biomet, and Zimmer.

 

Under Morris’ leadership, the company achieved much success including earning many Supplier of the Year awards from various customers. In fact, Medtronic, a multi-billion dollar international leader in the medical industry, ranked IMC among its top global suppliers for its Spine and Biologics division.

 

After several years of high profitability, Morris negotiated a successful exit strategy and sold the company in 2011. He remained on as President for more than two years following the sale.

 

After leaving IMC, from 2014 to 2016, he formed Creative Manufacturing Consulting Solutions (CMCS), a consulting company focused on achieving sustainable manufacturing solutions in the areas of operational and process optimization, quality system development and optimization, and industry and regulatory compliance – particularly those related to ISO and the FDA.

 

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While leading CMCS, Morris simultaneously conducted more than two years of in-depth research into the specific processes and technologies of the 3D bioprinting and regenerative medicine field – and quickly recognized the nearly unlimited financial and human potential of this emerging market. Coupling his vast hands-on experience in medical manufacturing with extensive research and a partnership with industry-leading experts he formed BIOLIFE4D in 2016, a regenerative medicine 3D bioprinting company with the goal of facilitating the biological printing of viable human organs for utilization in patient-specific human transplantation.

 

Morris went to college at Tulane University as an undergraduate and then continued his studies at the University of Texas, Austin where he studied business. He has served for more than a decade on the executive board of the Illinois Manufacturing Foundation, a non-profit organization dedicated to job-specific skill set training and job placement for unemployed, underemployed, at-risk, and other individuals who faced challenges and are looking for a second chance. He is also a Big Brother, providing guidance and mentoring to the same individual for over 35 years.

 

Kate Lewis – President

 

Kate Lewis was appointed President in September 2020, after joining us in 2019 to lead our Market and Business Development efforts. Applying her commercialization expertise, she has been developing our message, identifying critical stakeholders, building strategic partnerships, and expanding marketplace position.

 

Lewis is a seasoned, strategic business executive, with over 25 years of experience, working alongside global leaders within the pharmaceutical, transplantation and regulatory industries. Accomplished in her field, she has served as an active Board member on the American Lung Association and has been a GlaxoSmithKline (“GSK”) President’s Club Award winner for many years. The strength of her relationships in the pharmaceutical and medical communities and her gift of communicating complex issues and technologies to the public is part of what Lewis brings to our team.

 

Lewis is dedicated to the mission of perfecting the technology to make viable organ replacement a safe, accessible, and affordable reality. As President, Lewis champions our message to individuals who could benefit most: patients with heart conditions, healthcare professionals treating individuals with cardiac issues, and pharmaceutical companies developing new therapies/treatments which require cardiotoxicity testing, as part of their FDA approval process.

 

Prior to joining us, Lewis was Founder of Nottingham Associates from June 2000 to December 2016, a consulting firm focused on strategic client solutions for Pharma. Her work included refining market development initiatives and building Key Opinion Leader (KOL) boards within the pharmaceutical industry, clinical research, medical associations, and advocacy organizations. Another significant accomplishment was assisting to increase market share of the number one treatment of asthma globally and contributing to the improvement in quality-of-life for countless individuals suffering from asthma. Additionally, through a collaboration with Harvard University and GSK, Lewis helped design a groundbreaking study - “Asthma in America” – which helped identify 4.3 million individuals with previously undiagnosed asthma.

 

Lewis received her Bachelor’s in Fine Arts and Business from Ball State University and San Diego State University, respectively. She has earned certificates from Harvard University Executive Leadership Programs and as a National Asthma Educator. She has been trained in Tony Robbins Business Mastery, Stephen Covey’s Leadership, Myers-Briggs Type Indicator (MBTI), and in Fine Arts Mastery from the Cleveland Foundation. She also actively participates in National Association for Female Executives and Women in BIO.

 

Lewis has come full circle in her mission to advance the health and wellness of others. Having lost her husband to a heart attack and her father to lung disease as a child, she has dedicated her professional career to education and advancing therapies which improve the quality-of-life for others. Lewis’ other passions include being involved in community, philanthropic, and humanitarian activities. These include being a founder and serving on the Board of Home of the Sparrow for abused and battered women and spearheading medical relief efforts and humanitarian aid for both Hurricane Irma and Maria survivors in the Caribbean. Lewis also enjoys spending time with her two sons and extended family.

 

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Wesley Ramjeet – Chief Financial Officer

 

Wesley Ramjeet is the founder and CEO of PPMT Strategic Group, a New York based consulting firm since 2014. Mr. Ramjeet has been the Managing Partner of Profit Planners, Inc., a private New York consulting company since 2003. Mr. Ramjeet is the Founder and Chairman of MD Logic Health a supplement company that sells nutritional supplements to doctors and direct to consumers. Mr. Ramjeet is also the Chairman of SNN, Inc a financial media company that covers the micro-cap marketplace. Prior to founding Profit Planners, Inc., Mr. Ramjeet was the interim Chief Financial Officer of Youth Stream Media, Inc., a NASDAQ-traded public company. Mr. Ramjeet began his professional career in the Entrepreneurial Services Group at Ernst and Young, LLP. During his nine years at Ernst and Young, Mr. Ramjeet served both private and publicly traded companies in various industries. Mr. Ramjeet received his bachelor’s degree in accounting from St. John’s University and is a CPA.

 

Jeffrey Adam Morgan, M.D., FACS, FACC –Chief Medical Officer

 

An accomplished academic and medical professional, Dr. Morgan is currently a Cardiac Surgeon and Surgical Director at Sheba Medical Center in Tel Aviv where he has served since May 2019. Dr. Morgan has held multiple positions of leadership at Baylor College of Medicine from January 2016 through May 2019, including Chief of the Division of Cardiothoracic Transplantation and Circulatory Support; Surgical Director for the Advanced Heart Failure Center of Excellence, and the Lester and the Sue Smith Endowed Chair of Surgery. He was also Surgical Director of Mechanical Circulatory Support and Cardiac Transplantation at Texas Heart Institute.

 

Dr. Morgan specializes in treating patients with advanced heart and/or lung failure. Dr. Morgan implants mechanical circulatory support devices for left ventricular, right ventricular, or biventricular failure as a bridge to transplant (BTT) or destination therapy (DT). This includes left ventricular assist devices (LVADs), such as the HeartMate II, HeartMate III, and HeartWare HVAD, as well as the Syncardia total artificial heart (TAH).

 

Dr. Morgan completed his General Surgery Residency at Mount Sinai Medical Center in New York and his Cardiothoracic Surgery Residency at New York University. He went on to complete fellowship training in cardiac transplantation and mechanical circulatory support at Columbia Presbyterian Medical Center.

 

Prior to joining the teams at Baylor and Texas Heart Institute, Dr. Morgan previously held a position as associate professor at Wayne State University School of Medicine. He served as surgical director for Mechanical Circulatory Support and associate director for Heart and Lung Transplantation at Henry Ford Hospital in Detroit.

 

Dr. Morgan’s research is focused on advanced heart failure with numerous publications, national and international presentations, and book chapters to his credit. He is the section editor for Adult Mechanical Circulatory Support for the American Society of Artificial Internal Organs (ASAIO) Journal and is on the Editorial Board of The Journal of Heart and Lung Transplantation. He is also a reviewer for several other journals including The Annals of Thoracic Surgery and the Journal of the American College of Cardiology. Dr. Morgan served on the ISHLT Standards and Guidelines Committee and was a Task Force chair for the ISHLT Guidelines for MCS. He is also a previous chair of the Cardiac Track Programming Committee for the ASAIO Annual Conference. Dr. Morgan has moderated numerous sessions on mechanical support and transplant at ASAIO, ISHLT, and the American College of Cardiology.

 

Dr. Morgan is passionate about improving outcomes in patients with advanced heart or lung failure. He has participated in numerous clinical trials including Thoratec’s HeartMate II BTT and DT trials, Heartware’s HVAD BTT and DT trials, the HeartMate III trial, and Syncardia’s 50 cc TAH trial.

 

In addition, he is investigating the utility of stem cells as an adjunct measure for myocardial recovery, as part of the LVAD MPC II trial.

 

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Dr. Morgan completed his undergraduate studies at Yeshiva University in New York City before earning an MD from Albert Einstein College of Medicine. He completed a residency in General Surgery at Mount Sinai Medical Center, a residency in Cardiothoracic Surgery at New York University and a Fellowship in Cardiac Transplantation and Mechanical Circulatory Support at Columbia Presbyterian Medical Center.

 

Dr. Morgan is a member of the American Medical Association, the International Society of Heart and Lung Transplant, the Society of Thoracic Surgeons, and the American Society for Artificial Internal Organs. He is also certified by the American Board of Thoracic Surgery and the American Board of General Surgery.

 

Stephen Simes - Director

 

Stephen Simes has proven success leading emerging specialty pharmaceutical companies in product development, financing business development, and mergers and acquisitions.

 

Currently, Stephen is Entrepreneur in Residence at Helix 51 and the Innovation and Research Park of Rosalind Franklin University of Medicine and Science in North Chicago, Illinois. He is also chairman of the board for Bio-XL Limited, an Israeli company developing products in oncology and a board member of CytoDyn Inc. (OTCQB: CYDY). Stephen is an advisor for SmartHealth Catalyzer and an advisor for several emerging companies in varied therapeutic areas including oncology and cardiology. Previously, he was on the board of directors for Therapix Biosciences (2016-2020), RestorGenex Corporation (2014-2016), Ceregene, Inc. (2009-2013), BioSante Pharmaceuticals (1998-2013), Unimed Pharmaceuticals, Inc. (1994-1997), Bio-Technology General (1993-1995), and Gynex Pharmaceuticals, Inc. (1989-1993). Stephen was the CEO for RestorGenex Corporation from 2014 to 2016. Prior to RestorGenex, from 1998 to 2013, Stephen was the President and CEO of BioSante Pharmaceuticals, which was acquired by ANI Pharmaceuticals (NASDAQ: ANIP) in June 2013. Stephen has a BSc in Chemistry from Brooklyn College of the City University of New York and an MBA from New York University.

 

Lisa Kelley — Director

 

Lisa Kelley is an accomplished Senior Finance/Operations Executive and Board Member with more than 25 years of success in the electronics, telecommunications, manufacturing, and consumer goods industries.

 

Currently, Lisa provides consulting and fractional CFO services. Previously, Lisa was the VP of Global Logistics at Avnet, Inc. (AVT), a Fortune 500 company that markets, distributes, and adds value to a wide variety of electronics components, enterprise computer products and embedded subsystems to a broad base of more than 100,000 customers and 800 suppliers with over $20 billion in revenue operating in 100+ countries. Lisa joined Avnet as the Chief Audit Executive leading risk management strategy and establishing global audit practice in trade compliance, anti-corruption and data privacy/cyber-security.

 

Prior to joining Avnet in 2014, Lisa was in several senior leadership roles at Asurion, a global leader in technology protection services with over $6 billion in revenue. During Lisa’s nine years with Asurion she primarily served as the Group CFO for Asurion Global Supply Chain, Customer Care & Program Management. Before joining Asurion, Lisa was the Chief Accounting Officer for Brightpoint, a publicly traded company, which was acquired by Ingram Micro in 2012. Brightpoint was a $1.9 billion distribution and logistics services company supporting the global wireless telecommunications and data industry. From 1992 through 2003, Lisa had varied roles with Plexus Corp., a publicly traded global electronics contract manufacturer. Roles included Vice-President of Corporate Development, Vice-President of Finance, Corporate Controller and Treasurer.

 

Lisa has six years of public accounting experience, is a Certified Public Accountant, Certified Global Management Accountant, and Certified Management Accountant with an MBA from the University of Wisconsin. Lisa currently serves on another publicly traded company board (Quanergy NYSE:QNGY), two private company boards (Barron Lighting Group and Project 2121), a not-for-profit board (Arizona Sustainability Alliance), and numerous professional boards including chair of the Association of International Certified Professional Accountants (AICPA) Joint Trial Board, past member of the AICPA Board of Trustees, and past-chair of Tennessee State University Accounting Advisory Board.

 

She is active within her profession as she has served on various executive committees for the AICPA, AACSB Accounting Accreditation committee, past-chair of the Financial Executives International - Nashville chapter, and a past-member of the Tennessee Society of Certified Public Accountants and the Wisconsin Institute of Certified Public Accountants.

 

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Scientific Advisory Board

 

Our Scientific Advisory Board is comprised of various individuals who are leaders in their specific research activities, including but not limited to life sciences, biomaterials, bioprinting, organ transplantation, and more, all of which contribute to the ultimate process of bioengineering cardiac constructs. Our Scientific Advisory Board is strategically organized to take advantage of each advisor’s expertise as we concentrate on related activities in the lab. While there are no formal rules or procedures for the Scientific Advisory Board, scientific advisors typically engage now via virtual meetings where they interact with appropriate members of the laboratory team in real-time, lending expertise and guidance as needed. There are also regularly scheduled telephone calls with advisors and advisors visit the lab in person as requested. Science advisors have been compensated both in stock as well as paid for their time.

 

Our Scientific Advisory Board is led by Jeffrey Adam Morgan, M.D., FACS, FACC, our Chief Medical Officer, whose biography appears above. Following is a summary of certain biographical information concerning the other members of our Scientific Advisory Board.

 

Ravi Birla, Ph.D. - Senior Science Advisor

 

Dr. Ravi Birla is our Senior Science Advisor, directing our acclaimed team of scientists and helping to guide our strategic direction.

 

A highly regarded expert in the field of cardiac tissue and organ fabrication, cardiac tissue engineering, and regenerative medicine, Dr. Birla has specific interests in whole heart bioengineering, fabrication of 3D heart muscle, bioartificial ventricles, valves, and blood vessels.

 

Dr. Birla earned a Ph.D. in biomedical engineering from the University of Michigan, Ann Arbor, and was also recruited to serve as Director of the Artificial Heart Laboratory with the Division of Cardiac Surgery at the renowned University of Michigan Medical School. Earlier, Dr. Birla received BS and MS degrees in chemical engineering from the University of the West Indies at its St. Augustine Campus.

 

He has also served as a professor at both Tulane University and the University of Houston, and during both appointments, was the Principal Investigator of its NIH-funded Artificial Heart Laboratory.

 

Prior to joining us, Dr. Birla served as the Associate Director of the Department of Stem Cell Engineering at the Texas Heart Institute, where he led day-to-day operations and scientific direction for large scale research initiatives.

 

Dr. Birla has published more than 50 peer-reviewed scientific papers and holds several patents in the area of cardiovascular tissue engineering. He is also actively engaged in education and teaching related activities and has published a comprehensive textbook in the area of functional tissue engineering.

 

Ibrahim Ozbolat, Ph.D.

 

Dr. Ibrahim Ozbolat is an Associate Professor of Engineering Science and Mechanics in the Biomedical Engineering Department at The Pennsylvania State University.

 

He received his Ph.D. in tissue engineering from the University at Buffalo (SUNY) in Buffalo, New York, and dual B.S. degrees in Mechanical Engineering and in Industrial Engineering from Middle East Technical University in Ankara, Turkey.

 

At Penn State, Dr. Ozbolat is a faculty member of the Huck Institute of the Life Sciences, Materials Research Institute, Center for Neural Engineering, Center for Innovative Materials Processing through Direct Digital Deposition, and Center for Research on Advanced Fiber Technologies. Previously, he was a faculty member of The University of Iowa, Iowa City, Iowa and spearheaded the Advanced Manufacturing Technology Group and the Biomanufacturing Laboratory.

 

He is also Principal Investigator at the Ozbolat Lab at Penn State, focusing on establishing cutting-edge bioprinting science and technology for various areas in regenerative medicine. Dr. Ozbolat’s major research thrust is in the area of Bioprinting and Tissue Engineering, with a focus on establishing cutting-edge bioprinting science and technologies in tissue and organ fabrication. Some of his current research interests include development of new bioinks for advanced tissue printing, development of new bioprinter technologies, understanding the physics of the bioprinting process, and scaling up the 3D bioprinting process for tissues and organs.

 

Dr. Ozbolat’s research on bioprinting for tissue and organ fabrication has been published in several high regarded venues. He has received various awards and been featured in national and international media numerous times. He frequently presents at global forums, conferences and seminars and organizes demonstrations and events for the public and youth – encouraging the participation of future leaders in medicine, engineering, and science.

 

Sean Palecek, Ph.D.

 

Dr. Sean Palecek is a Professor of Chemical and Biological Engineering at the University of Wisconsin at Madison. He is also affiliated with the Department of Biomedical Engineering, the Stem Cell and Regenerative Medicine Center, and WiCell Research Institute.

 

He received his B.Ch.E. in Chemical Engineering from the University of Delaware majoring in chemical engineering with a minor in biology, M.S. in Chemical Engineering from the University of Illinois at Urbana-Champaign, and Ph.D. in Chemical Engineering from MIT.

 

Dr. Palecek is also Principal Investigator of the Palecek Group, with research interests that include cellular engineering, tissue engineering, stem cells, intercellular communication, and robust cardiomyocyte differentiation.

 

His team at the Department of Chemical and Biological Engineering at the University of Wisconsin at Madison identifies chemical and mechanical cues that regulate human pluripotent stem cell self-renewal and differentiation, then uses those principles to design culture systems that apply those cues in the appropriate spatial and temporal manner.

 

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His team has developed a protocol for the differentiation of stem cells which is uniform, inexpensive, and far more efficient than alternative strategies. The protocol is both efficient and robust. The ability to make key heart cells in abundance and in a precisely defined way is critical because it shows the potential to make the production of large, uniform batches of cardiomyocytes.

 

He is interested in characterizing the nature in which quantitative changes in the flow of cellular signals and cellular signaling networks can control a wide variety of cellular processes in order to design strategies to stimulate or inhibit cellular signaling pathways either at the chemical or physical level, and thereby regulate cell functions. Stem cells make differentiation decisions based on signals from their microenvironment and he is likewise interested in how adhesive forces and mechanical strain affect self-renewal and differentiation. Dr. Palecek is a recipient of a National Science Foundation CAREER award.

 

Shayn Peirce-Cottler, Ph.D.

 

Dr. Shayn Peirce-Cottler is Professor of Biomedical Engineering (BME), Professor of Ophthalmology (joint appointment), and Professor of Plastic Surgery (joint appointment) at the University of Virginia. She is also a member of the Cardiovascular Research Center (CVRC) and Associate Director of the Cardiovascular Training Grant (CVTG).

 

Her research focus is on tissue engineering and regeneration, computational systems biology, vascular growth and remodeling, stem cell therapies, with numerous research publications to her credit.

 

Dr. Peirce-Cottler is Principal Investigator at UVa’s Peirce-Cottler Laboratory which uses a parallel approach that combines experimental models with agent-based computational models to guide the development of new approaches in tissue engineering and regenerative medicine. That work earned her induction to the American Institute for Medical and Biological Engineering’s College of Fellows.

 

Dr. Peirce-Cottler teaches courses at the undergraduate and graduate levels, and has also taught lectures and seminars to Medical School students and Medical Residents. For six years, she taught the year-long BME Capstone Design course required for all undergraduates at UVA majoring in BME. She also teaches a “Introduction to Biomedical Engineering” course offered to all second year BME students at UVa, covering such topics as medical device design, regulation and commercialization, communication, professionalism, and ethics.

 

Dr. Peirce-Cottler earned her Ph.D in Biomedical Engineering from UVa, along with B.S. degrees in Biomedical Engineering and Engineering Mechanics from Johns Hopkins University. In 2004, she was named to MIT Technology Review’s annual list of “Innovators Under 35.”

 

Raimond L. Winslow, Ph.D.

 

Dr. Raimond L. Winslow is a Professor of Biomedical Engineering, Computer Science & Clinical and Rehabilitation Sciences at Northeastern University College of Engineering, Khoury Collee of Computer Sciences, Bouve College of Health Sciences. He is also the Director of Life Sciences & Medical Research at the Roux Institute at Northeastern University, Portland, Maine. Prior to Northeastern, Dr. Winslow was Professor of Biomedical Engineering at the Johns Hopkins University School of Medicine and held an additional appointment in the Whiting School of Engineering at Johns Hopkins, where he served as Director of the Institute for Computational Medicine and Director of the Center for Cardiovascular Bioinformatics and Modeling.

 

Dr. Winslow holds a B.S. in electrical engineering from Worcester Polytechnic Institute and a Ph.D. in biomedical engineering from the Johns Hopkins University. He concluded his training at the Institute for Biomedical Computing and Department of Neurology within Washington University in St. Louis. He joined the faculty of Johns Hopkins in 1991 as an assistant professor, became an associate professor in 1994 and a full professor in 2000.

 

Dr. Winslow is a fellow of the Biomedical Engineering Society, American Heart Association and American Institute for Medical and Biological Engineering. He serves as Specialty Editor in Chief for the journal Frontiers in Computational Physiology and Medicine, and as a member of the editorial boards of Circulation Research, The Journal of Molecular and Cellular Cardiology, IET Systems Biology and the International Journal of Computational Medicine and Healthcare. He has authored or co-authored more than 130 peer-reviewed articles and 12 book chapters, received numerous grants and awards, and holds one patent.

 

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Janet Zoldan, Ph.D.

 

Dr. Janet Zoldan is assistant professor at The University of Texas at Austin in the Department of Biomedical Engineering. She received her master’s degree and Ph.D. in materials engineering from Technion-Israel Institute of Technology, after which she completed her postdoctoral training at the Massachusetts Institute of Technology.

 

Dr. Zoldan is also Principal Investigator at The Zoldan Group, a research lab focused on human induced pluripotent stem cells (iPSCs) as a model system to explore key principles underlying tissue formation processes by integrating and applying materials and stem cell bioengineering.

 

The Zoldan Group is a dedicated to further elucidating the effects of a stem cell’s microenvironment on the cell’s proliferation, migration, and differentiation.

 

Utilizing a unique microfluidic device to deliver proteins into the cytoplasm of iPSCs, Zoldan Group researchers direct iPSC differentiation into cardiac lineages to develop safe, efficient, and robust production of patient-specific cell lines for cell replacement therapies and cardiovascular tissue engineering applications. The pluripotency of stem cells is used to create multi-cellular tissue-structures and induce tissue organization during cellular differentiation.

 

Dr. Zoldan has been recognized as a Children’s Glaucoma Foundation Fellow, an Aly Kaufmann Fellow, and with a Katz Family Award for Outstanding Excellency. Her research is featured in numerous publications such as the Proceedings of the National Academy of Sciences as well as the international journal Biomaterials.

 

Family Relationships

 

There are no family relationships between any of our directors or executive officers.

 

Board Composition

 

Our board of directors currently consists of three persons. After the completion of this offering, we expect our board of directors to remain the same, until the next election of directors by our shareholders.

 

Our board of directors believes its members collectively have the experience, qualifications, attributes and skills to effectively oversee our management, including a high degree of personal and professional integrity, an ability to exercise sound business judgment on a broad range of issues, sufficient experience and background to have an appreciation of the issues facing us, a willingness to devote the necessary time to board duties, a commitment to representing our best interests and the best interests of our shareholders, and a dedication to enhancing shareholder value.

 

There were no board of directors meetings held in 2021. All board actions were taken by unanimous written consent of the directors.

 

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Director Independence

 

We currently have two independent directors on our board of directors. We use Nasdaq’s definition of “independence” to make this determination. Nasdaq provides that an “independent director” is a person other than an executive officer or employee of the company or any other individual having a relationship with which, in the opinion of the company’s board of directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. The rules provide that a director cannot be considered independent if:

 

  the director is, or at any time during the past three years was, an employee of the company;
  the director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period of 12 consecutive months within the three years preceding the independence determination (subject to certain exemptions, including, among other things, compensation for board or board committee service);
  the director is a family member of an individual who is, or at any time during the past three years was, employed by the company as an executive officer;
  the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three years, any of the executive officer of the company served on the compensation committee of such other entity;
  the director or a family member of the director is a partner in, controlling shareholder of, or an executive officer of an entity to which the company made, or from which the company received, payments for property or services in the current or any of the past three fiscal years that exceed 5% of the recipient’s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exemptions); or
  the director or a family member of the director is a current partner of the company’s outside auditor, or at any time during the past three years was a partner or employee of the company’s outside auditor, and who worked on the company’s audit.

 

Under such definitions, our board of directors has undertaken a review of the independence of each director and will review the independence of any new directors based on information provided by each director concerning his background, employment, and affiliations, in order to make a determination of independence. Our board of directors has determined that there are two independent directors on our board of directors.

 

Role of Our Board of Directors in Risk Oversight

 

One of the key functions of our board of directors is informed oversight of our risk management process. Our board of directors administers this oversight function directly, and will have supporting committees, including the audit committee, compensation committee, and the nominating and corporate governance committee, who each will then support the board of directors by addressing risks specific to its respective areas of oversight. In particular, our audit committee has the responsibility to consider and discuss our major financial risk exposures and the steps our management takes to monitor and control these exposures, including guidelines and policies to govern the process by which risk assessment and management is undertaken. The audit committee also monitors compliance with legal and regulatory requirements, in addition to oversight of the performance of our internal audit function. Our compensation committee assesses and monitors whether any of our compensation policies and programs has the potential to encourage excessive risk-taking.

  

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Committees of Our Board of Directors

 

We currently have an audit committee; compensation committee; and a nominations and corporate governance committee.

 

Audit Committee. We intend to comply with the requirements of Rule 10A-3 of the Exchange Act and applicable Nasdaq corporate governance rules. These rules require that our audit committee be composed of at least three members. At the effective date of the registration statement of which this prospectus forms a part, the audit committee must include one independent director. After 90 days from the effective date of the registration statement, the audit committee is required to be comprised of a majority of independent directors. After one year from the effective date of the registration statement, the audit committee must be exclusively independent directors. The audit committee will be composed exclusively of “independent directors” who are “financially literate” as defined under the Nasdaq listing standards. The Nasdaq listing standards define “financially literate” as being able to read and understand fundamental financial statements, including a company’s balance sheet, income statement and cash flow statement. In addition, we have certified to Nasdaq that the committee has, and will continue to have, at least one member who has past employment experience in finance or accounting, requisite professional certification in accounting, or other comparable experience or background that results in the individual’s financial sophistication.

 

On the effective date of the registration statement of which this prospectus forms a part, our audit committee is composed of Steven Morris, Stephen Simes, and Lisa Kelley, whereby two of the three members are independent. Our board of directors has affirmatively determined that Lisa Kelley and Stephen Simes meets the definition of “independent director” for purposes of serving on an audit committee under Rule 10A-3 and Nasdaq rules. Lisa Kelley is the chairperson of our audit committee.

 

We have established a written charter for our audit committee, in which we set forth the duties of the audit committee to, among other matters, oversee (i) our financial reporting, auditing and internal control activities; (ii) the integrity and audits of our financial statements; (iii) our compliance with legal and regulatory requirements; (iv) the qualifications and independence of our independent auditors; (v) the performance of our internal audit function and independent auditors; and (vi) our overall risk exposure and management. Duties of the audit committee shall also include:

 

  annually review and assess the adequacy of the audit committee charter and the performance of the audit committee;
     
  be responsible for the appointment, retention, and termination of our independent auditors and determine the compensation of our independent auditors;
     
  review with the independent auditors the plans and results of the audit engagement;
     
  evaluate the qualifications, performance, and independence of our independent auditors;
     
  have sole authority to approve in advance all audit and non-audit services by our independent auditors, the scope and terms thereof, and the fees therefor;
     
  review the adequacy of our internal accounting controls; and
     
  meet at least quarterly with our executive officers, internal audit staff, and our independent auditors in separate executive sessions.

 

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Following this offering, a copy of the code of the audit committee charter will be available on our website at https://biolife4d.com/.

 

Compensation Committee.

 

Our compensation committee has overall responsibility for evaluating and approving the structure, operation, and effectiveness of the Company’s compensation plans, policies, and programs for officers and directors. We have established a charter for our compensation committee which will be available on our website at https://biolife4d.com/.

 

At the effective date of the registration statement of which this prospectus forms a part, the compensation committee must include one independent director. After 90 days from the effective date of the registration statement, the compensation committee is required to be comprised of a majority of independent directors. After one year from the effective date of the registration statement, the compensation committee must be exclusively independent directors.

 

On the effective date of the registration statement of which this prospectus forms a part, our audit committee is composed of Steven Morris, Stephen Simes, and Lisa Kelley, whereby two of the three members are independent. Lisa Kelley is the chairperson of the compensation committee.

 

Nominations and Corporate Governance Committee.

 

Our nominating and corporate governance committee provides oversight with respect to corporate governance and ethical conduct and monitors the effectiveness of our corporate governance guidelines, including whether such guidelines are successful in preventing illegal or improper liability-creating conduct. We have established a charter for our nominating and corporate governance committee which will be available on our website at https://biolife4d.com/.

 

At the effective date of the registration statement of which this prospectus forms a part, the nominating and corporate governance committee must include one independent director. After 90 days from the effective date of the registration statement, the nominating and corporate governance committee is required to be comprised of a majority of independent directors. After one year from the effective date of the registration statement, the nominating and corporate governance committee must be exclusively independent directors.

 

On the effective date of the registration statement of which this prospectus forms a part, our audit committee is composed of Steven Morris, Stephen Simes, and Lisa Kelley, whereby two of the three members are independent. Lisa Kelley is the chairperson of our audit committee.

 

Code of Business Conduct and Ethics

 

We have adopted a written code of business conduct and ethics that will apply to our directors, officers, and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and agents and representatives, including consultants. Following this offering, a copy of the code of business conduct and ethics will be available on our website at https://biolife4d.com/. We intend to disclose future amendments to such code, or any waivers of its requirements, applicable to any principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions or our directors on our website identified above. The inclusion of our website address in this prospectus does not include or incorporate by reference the information on our website into this prospectus.

 

Limitations on Liabilities and Indemnification of Directors and Officers

 

There are limitations of liability and indemnification and advancement rights applicable to our directors and officers. (See “Description of Securities—Limitations on Liability and Indemnification of Directors and Officers.”)

 

Director Compensation

 

We have a director compensation package that includes cash compensation as well as stock options. (See “Executive and Director Compensation—Director Compensation.”)

 

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EXECUTIVE AND DIRECTOR COMPENSATION

 

Executive Compensation

 

Summary Compensation Table

 

The following table summarizes information regarding the compensation for fiscal years 2021 and 2020 for our named executive officers.

 

Name and Principal Position  Year   Salary ($)   Stock
Awards
($)
   Option
Awards
($)
   All Other
Compensation
($)
   Total ($) 
Steven Morris, Chief Executive Officer, Secretary, and Chairman of the Board of Directors   2021    240,000    -0-    -0-    -0-    240,000 
    2020    240,000    -0-    -0-    -0-    240,000 
Kate Lewis, President   2021    120,000    -0-    -0-    -0-    120,000 
    2020    120,000    -0-    -0-    -0-    120,000 
Jim Hechtman, Former Chief Financial Officer and Treasurer(1)   2021    -0-    -0-    -0-    -0-    

-0-

 
    2020    -0-    -0-    -0-    -0-    -0- 
Dr. Jeffrey Morgan, Chief Medical Officer   2021    -0-    -0-    261,000    -0-    261,000 
    2020    7,500    -0-    -0-    -0-    7,500 

 

  (1) Resigned effective February 1, 2022; was not compensated personally, but the accounting firm for which he is a partner invoiced the Company for bookkeeping services in the amount of $24,260 and $17,265 for 2020 and 2021, respectively.

 

Narrative to Summary Compensation Table

 

We believe that the primary goal of executive compensation is to align the interests of our executive officers with those of our shareholders in a way that allows us to attract and retain the best executive talent.

 

Annual Base Salary. Base salary is designed to compensate our named executive officers at a fixed level of compensation that serves as a retention tool throughout the executive’s career. In determining base salaries, our compensation committee considers each executive’s role and responsibility, unique skills, future potential with us, salary levels for similar positions in our market and internal pay equity.

 

Option Plan. We plan to offer option awards to executives and other employees, in the discretion of the board of directors, considering the executive’s role and other compensation.

 

Health/Welfare Plans. We have a healthcare plan available to all employees, including our executives, who become eligible after 90 days of employment.

 

PTO Plan. Executives may take PTO at any time, at their own reasonable discretion.

 

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Employment Agreements with our Named Executive Officers

 

Steven Morris – Employment Agreement

 

We have an employment agreement with our Chief Executive Officer, Steven Morris, as of September 2, 2022, and effective as of the date of effectiveness of this registration statement, for a term of two years, subject to automatic renewal for additional one year periods unless either we or Mr. Morris gives notice of intent not to renew. Mr. Morris is entitled to an annual salary of $300,000, and an annual cash bonus opportunity of 20% of his annual salary, as determined by and awarded by the Compensation Committee. We also reimburse Ms. Morris for all reasonable costs and expenses incurred in performing services for us, including reimbursement for Mr. Morris’ monthly leasing and other related transportation costs up to but not exceeding $1,000 per month and cellular expenses. Mr. Morris may be terminated for Cause. If Mr. Morris is terminated without Cause, Mr. Morris is entitled to receive a severance payment of one and a half times his annual salary and continuing medical insurance for 18 months following his termination or until he is eligible to participate in another party’s group health plan, whichever comes first.

 

Kate Lewis- Employment Agreement

 

We have an employment agreement with our President, Kate Lewis, effective as of September 15, 2020 and terminable at any time by either party upon two weeks prior notice. Ms. Lewis is entitled to a monthly gross salary of $10,000 and is eligible to participate in any of our sponsored benefit programs. We also reimburse Ms. Lewis for all reasonable costs and expenses incurred in performing services for us.

 

Wesley Ramjeet- CFO Agreement

 

We have a consulting agreement with our Chief Financial Officer, Wesley Ramjeet, effective as of February 1, 2022, and amended on August 11, 2022, for a term of two years, subject to extension by mutual agreement unless terminated earlier by either party upon 30 days written notice. Mr. Ramjeet serves as a non-employee Chief Financial Officer for 40 hours per week. Mr. Ramjeet is entitled to compensation of (a) initial cash compensation of $5,000 upon execution of the agreement; (b) $5,000 per month for the next 23 months (or until the agreement is terminated) for up to 20 hours of services per month; (c) any additional time over 20 hours per month shall be billed at $350 per hour; and (d) 667 shares of common stock pursuant to our 2022 Restricted Stock Plan for each month that Mr. Ramjeet is our CFO. We also reimburse Mr. Ramjeet for all reasonable and pre-approved out-of-pocket expenses incurred in performing services for us.

 

Dr. Jeffrey Morgan- Advisory Board Agreement

 

Our Chief Medical Officer, Dr. Jeffrey Morgan, has an Advisory Board Agreement, as amended, effective February 1, 2022, whereby he currently receives $2,500 per month to serve as our CMO, participate in Advisory Board meetings, and to be available on an as-needed basis for research, lab set up, research and development and strategy. Dr. Morgan’s compensation will increase to $5,000 per month when we enter the next stage of development of product and he is requested to perform services in connection with the design of GLP preclinical studies, creations of data reports, establishment of clinical criteria for human implantation, selection of trial sites, standardization of clinical protocols, post-operative care, and similar services. To date, Dr. Morgan has been granted 2,500 shares of common stock and has options to purchase 13,334 shares of our common stock at an exercise price of $30.00 per share and 17,337 shares of our common stock at an exercise price of $40.50 per share. Dr. Morgan continues to earn 667 stock options per month for his services to us.

 

Director Compensation

 

From our inception on November 14, 2016 to 2021, we paid no compensation to any member of our board of directors for services rendered as a director.

 

On February 4, 2022, we entered into Director Agreements with each of the members of the board of directors. Pursuant to the Director Agreements, the compensation to the directors is as follows: (a) cash compensation of $30,000 per annum; and (b) an annual grant of options to purchase 8,334 shares of common stock, the first grant being on the day of appointment, and thereafter being on the date of each annual re-election or re-appointment to the board of directors (the “Annual Grant”). The Annual Grant will vest in full on the first anniversary of each grant date. In addition, in the event that the director is a member of any committee, he or she will be entitled to (c) additional annual cash compensation of $4,000 for being a non-chair member; or (d) additional annual cash compensation of $8,000 for being the chair of a committee.

 

2022 Stock Option Plan

 

On February 3, 2022, we adopted the 2022 Incentive and Nonstatutory Stock Option Plan which provides for the grant of incentive stock options within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”), to our employees and the employees of any future subsidiary corporation, and for the grant of non-statutory stock options to non-employees, including directors and other service providers (the “2022 Stock Option Plan”).

 

Authorized Shares. A total of 1,666,667 shares of our common stock have been reserved for issuance pursuant to the exercise of options issued from the 2022 Stock Option Plan.

 

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Plan Administration. Our board of directors administers our 2022 Stock Option Plan.

 

Stock Options. Stock options may be granted under our 2022 Stock Option Plan. The exercise price of options granted under our 2022 Stock Option Plan must at least be equal to the fair market value of our common stock on the date of grant. The term of an incentive stock option may not exceed ten years, except that with respect to any participant who owns more than 10% of the voting power of all classes of our outstanding stock, the term must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. The administrator will determine the methods of payment of the exercise price of an option, which may include cash, shares, or other property acceptable to the administrator, as well as other types of consideration permitted by applicable law. After the termination of service of an employee, director, or consultant, he or she may exercise his or her option for the period of time stated in his or her option agreement. Generally, if termination is due to death or disability, the option will remain exercisable for 12 months. In all other cases, the option will generally remain exercisable for three months following the termination of service. However, in no event may an option be exercised later than the expiration of its term. Subject to the provisions of our 2022 Stock Option Plan, the administrator determines the other terms of options.

 

Options Granted. To date, pursuant to our 2022 Stock Option Plan, we have issued to our employees, officers, and directors 30,334 options to purchase shares of our common stock.

 

Non-transferability of Awards. Unless the administrator provides otherwise, our 2022 Stock Option Plan generally does not allow for the transfer of awards and only the recipient of an award may exercise an award during his or her lifetime.

 

Certain Adjustments. In the event of certain changes in our capitalization, to prevent diminution or enlargement of the benefits or potential benefits available under our 2022 Stock Option Plan, the administrator will adjust the number and class of shares that may be delivered under our 2022 Stock Option Plan and/or the number, class and price of shares covered by each outstanding award and the numerical share limits set forth in our 2022 Stock Option Plan. In the event of our proposed liquidation or dissolution, the administrator will notify participants as soon as practicable, and all awards will terminate immediately prior to the consummation of such proposed transaction.

 

Merger or Change in Control. Our 2022 Stock Option Plan provides that in the event of a merger or change in control, as defined under the 2022 Stock Option Plan, each outstanding award will be treated as the administrator determines, except that if a successor corporation or its parent or subsidiary does not assume or substitute an equivalent award for any outstanding award, then such award will fully vest, all restrictions on the shares subject to such award will lapse, all performance goals or other vesting criteria applicable to the shares subject to such award will be deemed achieved at 100% of target levels and all of the shares subject to such award will become fully exercisable, if applicable, for a specified period prior to the transaction. The award will then terminate upon the expiration of the specified period of time.

 

Amendment; Termination. The administrator has the authority to amend, suspend, or terminate the 2022 Stock Option Plan provided such action will not impair the existing rights of any participant. Our 2022 Stock Option Plan will automatically terminate in 2032, unless we terminate it sooner.

 

2022 Restricted Stock Plan

 

On February 3, 2022, the board of directors adopted the 2022 Restricted Stock Plan (the “2022 Restricted Stock Plan”) which provides for the grant of common stock awards and performance awards to our officers, directors, and key employees or of any subsidiary corporation.

 

Purpose of the Plan. The 2022 Restricted Stock Plan is intended to provide incentives which will attract, retain, motivate, and reward our officers, directors, and key employees or any of our Affiliates (“Participants”), by providing them opportunities to acquire shares of our common stock.

 

Stock Subject to the Plan. The aggregate number of shares of common stock that may be subject to Awards granted under the 2022 Restricted Stock Plan is 1,666,667 shares of common stock. If any shares of common stock are forfeited, retained by us as payment of tax withholding obligations with respect to an Award, or surrendered to us to satisfy tax withholding obligations, such shares of common stock will be added back to the shares available for Awards. The 2022 Restricted Stock Plan contains certain adjustment provisions relating to stock dividends, stock splits, and the like.

 

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Administration of the Plan. The 2022 Restricted Stock Plan will be administered by the board of directors. The board of directors will have the full power and authority to grant Awards to the persons eligible to receive such Awards and to determine the amount, type, terms, and conditions of each such Award.

 

Eligibility. Participants consist of such officers, directors, and key employees of us or any of our Affiliates as the board of directors, in its sole discretion, determines to be significantly responsible for our success and future growth and profitability and whom the board of directors may designate from time to time to receive Awards under the 2022 Restricted Stock Plan.

 

Types of Awards. Stock Awards and Performance Awards may, as determined by the board of directors, in its discretion, constitute Performance-Based Awards.

 

Stock Awards. The board of directors is authorized to grant Stock Awards and will, in its sole discretion, determine the recipients and the number of shares of common stock underlying each Stock Award. Each Stock Award will be subject to such terms and conditions consistent with the 2022 Restricted Stock Plan as determined by the board of directors and as set forth in an Award agreement, including, without limitation, restrictions on the sale or other disposition of such shares and our right to reacquire such shares for no consideration upon termination of the Participant’s employment or membership on the board of directors, as applicable, within specified periods.

 

Performance Awards. The board of directors is authorized to grant Performance Awards and will, in its sole discretion, determine the recipients and the number of shares of common stock that may be subject to each Performance Award. Each Performance Award will be subject to such terms and conditions consistent with the 2022 Restricted Stock Plan as determined by the board of directors and as set forth in an Award agreement. The board of directors will set performance targets at its discretion which, depending on the extent to which they are met, will determine the number of Performance Awards that will be paid out to the Participants and may attach to such Performance Awards one or more restrictions. Performance targets may be based upon, without limitation, Company-wide, divisional and/or individual performance.

 

The board of directors has the authority to adjust performance targets. The board of directors also has the authority to permit a Participant to elect to defer the receipt of any Performance Award, subject to the 2022 Restricted Stock Plan.

 

Performance-Based Awards. Certain Stock Awards and Performance Awards granted under the 2022 Restricted Stock Plan and the compensation attributable to such Awards are intended to (i) qualify as Performance-Based Awards or (ii) be otherwise exempt from the deduction limitation imposed by Section 162(m) of the Code.

 

The board of directors determines whether Stock Awards and Performance Awards granted under the 2022 Restricted Stock Plan qualify as Performance-Based Awards. The board of directors will establish in writing the performance goals, the vesting period, the performance targets, and any other terms and conditions of the Award in its sole discretion.

 

Vesting. Awards granted to Participants under the 2022 Restricted Stock Plan may be subject to a graded vesting schedule with a minimum vesting period of two years, unless otherwise determined by the board of directors.

 

If there is a Change in Control, all unvested Awards granted under the 2022 Restricted Stock Plan will become fully vested immediately upon the occurrence of the Change in Control and such vested Awards will be paid out or settled, as applicable, within 60 days upon the occurrence of the Change in Control, subject to requirements of applicable laws and regulations.

 

Subject to the discretion of the board of directors, if a Participant’s employment or membership on the board of directors is terminated due to death or Disability, then all unvested and/or unearned Awards will be forfeited as of such date.

 

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Section 409A of the Code. Awards under the 2022 Restricted Stock Plan are intended either to be exempt from the rules of Section 409A of the Code or to satisfy those rules and shall be construed accordingly. However, we will not be liable to any Participant or other holder of an Award with respect to any Award-related adverse tax consequences arising under Section 409A or other provision of the Code.

 

Transferability. Each Award granted under the 2022 Restricted Stock Plan will not be transferable otherwise than by a will or the laws of decent and distribution or as otherwise decided by the board of directors.

 

Fair Market Value. For purposes of the 2022 Restricted Stock Plan, “Fair Market Value” means, as of any given date, the closing price of a share of common stock on The Nasdaq Stock Market LLC or such other public trading market on which shares of common stock are listed or quoted on that date.

 

Withholding. All payments or distributions of Awards made pursuant to the 2022 Restricted Stock Plan will be net of any amounts required to be withheld pursuant to applicable federal, state, and local tax withholding requirements.

 

Amendments. The board of directors may amend the 2022 Restricted Stock Plan from time to time or suspend or terminate it at any time. However, no amendment will be made, without approval of our shareholders to (i) increase the total number of shares which may be issued under the 2022 Restricted Stock Plan; (ii) modify the requirements as to eligibility for Awards under the 2022 Restricted Stock Plan; or (iii) otherwise materially amend the 2022 Restricted Stock Plan as provided in Nasdaq Marketplace Rules.

 

Term of the Plan. The 2022 Restricted Stock Plan will terminate on the tenth anniversary of its Effective Date.

 

Current Issuance. As of the date of this prospectus, there have been 6,584 shares of common stock issued under the 2022 Restricted Stock Plan.

 

Rule 10b5-1 Sales Plan

 

Our directors and executive officers may adopt written plans, known as Rule 10b5-1 plans, in which they would contract with a broker to buy or sell shares of our common stock on a periodic basis. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the director or officer when entering into the plan, without further direction from them. The director or executive officer may amend a Rule 10b5-1 plan in some circumstances and may terminate a plan at any time. Our directors and executive officers also may buy or sell additional shares outside a Rule 10b5-1 plan when they are not in possession of material nonpublic information subject to compliance with the terms of our policy on insider trading and communications with the public. Our directors and executive officers may not establish any such plan prior to the expiration of the lock-up agreements described under “Underwriting.”

 

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

 

We had the following transactions with related parties during the last two fiscal years:

 

In 2017, our CEO entered into an agreement to advance $250,000 to us to meet working capital needs. The advance bore interest at 9% per annum. In August 2020, the advance was repaid in full along with approximately $74,000 in accrued interest. In the year ended December 31, 2020, we recorded interest expense – related party for this advance in the amount of approximately $24,000.

 

In 2020 and 2021, we used the bookkeeping services of an accounting firm in which our former CFO was a partner. We incurred $17,265 and $24,260 of fees for accounting services in the years ended December 31, 2021 and 2020, respectively.

 

On May 18, 2022, our CEO, through his trust, the BioLife4D – SM Trust, obtained a $1 million loan from one of our shareholders pursuant to a Secured Promissory Note, dated as of May 18, 2022, in the principal amount of $1 million (the “SM Trust Loan”). The SM Trust Loan is secured by 33,334 shares of our common stock held by the BioLife4D – SM Trust pursuant to a Stock Pledge Agreement, dated as of May 18, 2022, by and between the BioLife4D – SM Trust, as pledgor, and the shareholder as secured party. The funds received from the SM Trust Loan were then placed in a deposit account with Fifth Third Bank, National Association (the “Deposit Account”) and used to serve as collateral for our $1 million Working Capital Loan from Fifth Third Bank, National Association (the “Lender”), pursuant to an Assignment of Deposit Account, dated May 18, 2022, by and among the BioLife4D – SM Trust, us, and the Lender.

 

Upon our receipt of funds from the offering, we intend to immediately pay off the Working Capital Loan. Following the payoff of the Working Capital Loan, the Deposit Account will be released and used by the BioLife4D – SM Trust to repay the SM Trust Loan. In addition, we intend to use a portion of funds from this offering to reimburse to the BioLife4D – SM Trust any expenses incurred by BioLife4D – SM Trust as a result of the SM Trust Loan and for any other principal, expenses, interest, or fees accrued and owed to the shareholder after the release of the Deposit Account funds pursuant to an agreement between us and the BioLife4D – SM Trust, dated May 18, 2022.

 

Steven Morris, our CEO, is the sole beneficiary and trustee of the BioLife4D – SM Trust and exercises voting power and control over the shares held by the trust.

 

Policies and Procedures for Transactions with Related Persons

 

All future related party transactions will be voted upon by the disinterested board of directors. The audit committee of the board of directors is responsible for evaluating each related party transaction and making a recommendation to the disinterested members of the board of directors as to whether the transaction at issue is fair, reasonable and within our policy and whether it should be ratified and approved. The audit committee, in making its recommendation, will consider various factors, including the benefit of the transaction to us, the terms of the transaction and whether they are at arm’s-length and in the ordinary course of our business, the direct or indirect nature of the related person’s interest in the transaction, the size and expected term of the transaction and other facts and circumstances that bear on the materiality of the related party transaction under applicable law and listing standards. The audit committee will review, at least annually, a summary of our transactions with our directors and officers and with firms that employ our directors, as well as any other related person transactions.

 

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PRINCIPAL STOCKHOLDERS

 

Immediately prior to the completion of this offering, there are 3,610,353 shares of our common stock outstanding as of the date of this prospectus. The following table sets forth the beneficial ownership of our common stock immediately prior to and immediately after the completion of this offering by:

 

  each of our directors;
     
  each of our named executive officers;
     
  all of our directors and executive officers as a group; and
     
  each person known by us to be the beneficial owner of 5% or more of our outstanding common stock.

 

The percentage ownership information after the offering assumes the issuance of shares of common stock in this offering, but does not assume the exercise of the underwriter’s overallotment option.

 

We have determined beneficial ownership in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities. In addition, the rules include shares of common stock issuable pursuant to the exercise of stock options and Warrants that are either immediately exercisable or exercisable on or before the date which is 60 days after the date of this prospectus. These shares are deemed to be outstanding and beneficially owned by the person holding those options and Warrants for the purpose of computing the percentage ownership of that person, but they are not treated as outstanding for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the persons or entities identified in this table have sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to applicable community property laws.

 

    Amount and Nature of Beneficial Ownership  
Name and Address of Beneficial Owner   Shares Owned
Immediately
Prior to this
Offering
    Percentage
Immediately
Prior to this
Offering
    Shares Owned
Immediately
After this
Offering
    Percentage
Immediately
After this
Offering
 
                         
Directors and Named Executive Officers:                                
Steven Morris, Chief Executive Officer, Secretary, Director     2,441,667 (1)     67.5 %     2,441,667 (1)    

40.4

%
                                 
Kate Lewis, President     403,473       11.2 %     403,473      

6.7

%
                                 
Wesley Ramjeet, Chief Financial Officer     7,337 (2)     *       7,337 (2)     *  
                                 
Dr. Jeffrey Morgan, Chief Medical Officer     33,171 (3)     *       33,171 (3)    

*

 
                                 
Stephen Simes, Director     11,668 (4)     *       11,668 (4)     *  
                                 
 Lisa Kelley, Director     -0-       -0-       -0-       -0-  
All directors and executive officers as a group (six persons)     2,895,982       79.1 %(5)     2,895,982      

60.7

%
                                 
Marvin Somlo     533,334     14.1 %     533,334      

8.8

%

 

*Less than 1%.

 

  (1) Includes 833,333 shares of common stock owned by the 1030 Trust and 1,600,000 shares of common stock owned by BioLife4D – SM Trust over which Mr. Morris exercises voting power and control of these shares held in those trusts as trustee of both trusts and 8,334 fully vested options to purchase common stock with an exercise price of $40.50. 33,334 of the 1,600,000 shares of common stock owned by BioLife4D – SM Trust are pledged as security under the SM Trust Loan.
  (2) Mr. Ramjeet is granted shares of common stock under the Company’s Restricted Stock Plan of 667 shares of common stock per month for his services to us beginning on February 1, 2022, and this amount reflects the 7,337 shares of common stock granted through December 2022.
  (3) Includes options to purchase 13,334 shares of common stock at an exercise price of $30.00 per share and option to purchase 10,000 shares of common stock at an exercise price of $40.50 per share. Dr. Morgan earns options to purchase 667 shares of common stock with an exercise price of $40.50 per month for his services to us beginning on February 1, 2022, and this amount reflects options to purchase 7,337 shares of common stock earned through December 2022.
  (4) Consists of fully vested option to purchase 3,334 shares of common stock with an exercise price of $30.00 and fully vested options to purchase 8,334 shares of common stock with an exercise price of $40.50 held by the Stephen M. Simes Trust, of which he is trustee.
  (5)

Based on a total of 3,661,026 shares deemed outstanding for the purposes of this table.

 

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DESCRIPTION OF SECURITIES

 

General

 

We were formed as a Delaware corporation as BioGen3D on November 14, 2016 and changed our name to BIOLIFE4D CORPORATION on June 5, 2017. We have 70,000,000 shares of authorized capital stock, consisting of 50,000,000 shares of common stock, $0.00001 par value, and 20,000,000 shares of preferred stock, $0.00001 par value. Immediately prior to this offering, there are 3,610,353 shares of our common stock outstanding. Upon the completion of this offering, as a result of the issuance of 2,419,354 shares in this offering, there will be 6,029,707 shares of our common stock issued and outstanding, and no shares of preferred stock issued and outstanding (assuming that the underwriters do not exercise their overallotment option).

 

Common Stock

 

Each holder of our common stock is entitled to one vote per each share on all matters to be voted upon by the common shareholders, and there are no cumulative voting rights. Subject to applicable law and the rights, if any, of the holders of outstanding shares of any series of preferred stock we may designate and issue in the future, holders of our common stock shall be entitled to vote on all matters on which shareholders generally are entitled to vote. Subject to the rights, if any, of the holders of outstanding shares of any series of preferred stock we may designate and issue in the future, holders of our common stock will be entitled to receive ratably the dividends, if any, as may be declared from time to time by our board of directors out of funds legally available for that purpose. If there is a liquidation, dissolution, or winding up of the Company, subject to the rights, if any, of the holders of outstanding shares of any series of preferred stock we may designate and issue in the future, holders of our common stock would be entitled to ratable distribution of our assets remaining after the payment in full of our liabilities.

 

Under the terms of our governing documents, the holders of our common stock have no preemptive or conversion rights or other subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. All currently outstanding shares of our common stock are fully paid and non-assessable. The rights of the holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.

 

We have applied to list our common stock on the Nasdaq Capital Market under the symbol “SAVU.”

 

Our transfer agent is ClearTrust, LLC, 16540 Pointe Village Drive, Suite 205, Lutz, Florida 33558, email address: inbox@cleartrusttransfer.com.

 

Preferred Stock

 

Our Certificate of Incorporation authorize our board of directors to establish one or more series of preferred stock. Unless required by law or any stock exchange, the authorized but unissued shares of preferred stock will be available for issuance without further action by our shareholders. Our board of directors is authorized to divide the preferred stock into series and, with respect to each series, to fix and determine the designation, terms, preferences, limitations, and relative rights thereof, including dividend rights, dividend rates, conversion rights, voting rights, redemption rights and terms, liquidation preferences, sinking fund provisions and the number of shares constituting the series. Without shareholder approval, we could issue preferred stock that could impede or discourage an acquisition attempt or other transaction that some, or a majority, of our shareholders may believe is in their best interests or in which they may receive a premium for their common stock over the market price of the common stock.

 

Stock Options

 

On February 3, 2022, we adopted the 2022 Stock Option Plan, pursuant to which we may grant equity awards to our employees, officers, directors, and certain service providers. There are 1,666,667 shares of our common stock reserved for issuance under the 2022 Stock Option Plan. As of the date of this prospectus, there were 25,000 shares of our common stock issuable upon exercise of outstanding stock option pursuant to the 2022 Stock Option Plan, all of which have an exercise price of $40.50 per share and a term of five years.

 

Prior to adopting the 2022 Stock Option Plan, we also issued stock options to four members of our former management advisory board pursuant to certain stock option agreements. As of the date of this prospectus, there were 65,000 shares of our common stock issuable upon exercise of outstanding stock options not part of our 2022 Stock Option Plan, all of which have an exercise price of $30.00 per share.

 

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Restricted Stock Awards

 

On February 3, 2022, we adopted the 2022 Restricted Stock Plan, pursuant to which we may grant common stock awards and performance awards to our officers, directors, and key employees. There are 1,666,667 shares of our common stock reserved for issuance under the 2022 Restricted Stock Plan. As of the date of this prospectus, there were no shares of our common stock awarded pursuant to the 2022 Restricted Stock.

 

Common Units

 

Each Common Unit consists of one share of common stock as described above and two Warrants, each exercisable for one share of common stock as described further below. The Common Units will not be issued or certificated. Purchasers of Common Units will receive only shares of common stock and Warrants. The common stock and Warrants may be transferred separately immediately upon issuance.

 

Warrants included in the Common Units

 

The following summary of certain terms and provisions of the Warrants offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the Warrant Agent Agreement between us and ClearTrust, LLC, as warrant agent (the “Warrant Agent”), and the form of Warrant, both of which are filed as exhibits to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions set forth in the Warrant Agent Agreement, including the annexes thereto, and form of Warrant.

 

Form. The Warrants will be issued under a Warrant Agent Agreement between us and ClearTrust, LLC, as Warrant Agent. The material terms and provisions of the Warrants offered hereby are summarized below. The following description is subject to, and qualified in its entirety by, the form of Warrant, which is filed as an exhibit to the registration statement of which this prospectus is a part. You should review a copy of the form of Warrant for a complete description of the terms and conditions applicable to the Warrants.

 

Exercisability. The Warrants are exercisable beginning on the date of issuance. The Warrants will thereafter remain exercisable at any time up to five years from the date of original issuance. The Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and, at any time a registration statement registering the issuance of the shares of common stock underlying the Warrants under the Securities Act is effective and available for the issuance of such shares, accompanied by payment in full in immediately available funds for the number of shares of our common stock purchased upon such exercise. If a registration statement registering the issuance of the shares of common stock underlying the Warrants under the Securities Act is not effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, the holder may elect to exercise the Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the Warrant. No fractional shares of common stock will be issued in connection with the exercise of a Warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price. The holder will not have the right to exercise any portion of the Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% (or 9.99% upon election prior to issuance of any Warrants) of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Warrants.

 

Exercise Price. Each Warrant represents the right to purchase one share of common stock at an exercise price equal to the public offering price per share of common stock, or $5.95 per share, subject to adjustment as described below. The exercise price is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications, or similar events affecting our common stock. Subject to certain exceptions outlined in the Warrant, for a period of two years from the date of issuance of the Warrant, if the Company issues or sells, enter into an agreement to sell and subsequently sells, or grant any option to purchase, or sells, enters into an agreement to sell and subsequently sells, or grants any right to reprice, or otherwise disposes of or issues (or announces any offer, sale, grant or any option to purchase or other disposition that subsequently closes) any shares of common stock or convertible security, at an effective price per share less than the exercise price of the Warrant then in effect (a “Dilutive Issuance”), then simultaneously with the consummation of such Dilutive Issuance, the exercise price of the Warrant shall be reduced to equal the effective price per share in such Dilutive Issuance; provided, however, that in no event shall the exercise price of the Warrant be reduced to an exercise price lower than 50% of the public offering price per share of common stock in this offering. On the date that is 90 calendar days immediately following the initial issuance date of the Warrants, the exercise price of the Warrants will adjust to be equal to the Reset Price, provided that such value is less than the exercise price in effect on that date. The Reset Price is equal to the greater of (a) 50% of the Initial Exercise Price of the Warrants on the issuance date and (b) 100% of the lowest daily volume weighted average price per share of common stock occurring on any day between the initial issuance date and 90 calendar days following the issuance date of the Warrants, that is from [  ], 2022 until [  ], 2022. The lowest Reset Price is $2.98, which is 50% of the offering price per share of common stock, based on an assumed offering price of $6.20 per Common Unit, the midpoint of the price range of the Common Units).

 

Transferability. Subject to applicable laws, the Warrants may be offered for sale, sold, transferred, or assigned without our consent.

 

Fundamental Transactions. In the event of a fundamental transaction, as described in the Warrants and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the Warrants will be entitled to receive upon exercise of the Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the Warrants immediately prior to such fundamental transaction without regard to any limitations on exercised contained in the Warrants. Notwithstanding the foregoing, in the event of a fundamental transaction, the holders of the Warrants have the right to require us or a successor entity to redeem the Warrants for cash (or other types or form of consideration in special circumstances listed in the Warrant) in the amount of the Black-Scholes Value (as defined in each Warrant) of the unexercised portion of the Warrants concurrently with or within 30 days following the consummation of a fundamental transaction.

 

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Rights as a Stockholder. Except as otherwise provided in the Warrants or by virtue of such holder’s ownership of shares of our common stock, the holder of a Warrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises the Warrant.

 

Governing Law and Jurisdiction. The Warrants and Warrant Agent Agreement provides that the validity, interpretation, and performance of the Warrants and the Warrant Agent Agreement will be governed by the laws of the State of New York, without giving effect to conflicts of law principles that would result in the application of the substantive laws of another jurisdiction.

 

Warrant Agent. ClearTrust, LLC will act as our Warrant Agent for the Warrants. The Warrants shall initially be represented only by one or more global Warrants deposited with the Warrant Agent, as custodian on behalf of The Depository Trust Company (DTC) and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.

 

Exchange Listing. We have applied to list the Warrants on Nasdaq under the symbol “SAVUW.” If the application is not approved, we will not complete this offering. No assurance can be given that a trading market will develop.

 

Underwriter’s Warrants

 

The material terms and provisions of the underwriter’s Warrants are described under the caption “Underwriting.”

 

Anti-Takeover Provisions

 

Delaware Law

 

We are subject to Section 203 of the Delaware General Corporation Law. This provision generally prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date the stockholder became an interested stockholder, unless:

 

-prior to such date, the board of directors approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
-upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding those shares owned by persons who are directors and also officers and by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
-on or subsequent to such date, the business combination is approved by the board of directors and authorized at an annual meeting or special meeting of stockholders and not by written consent, by the affirmative vote of at least 662/3% of the outstanding voting stock that is not owned by the interested stockholder.

 

Section 203 defines a business combination to include:

 

-any merger or consolidation involving the corporation and the interested stockholder;
-any sale, transfer, pledge, or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;
-subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
-any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or
-the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges, or other financial benefits provided by or through the corporation.

 

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In general, Section 203 defines an “interested stockholder” as any entity or person beneficially owning 15% or more of the outstanding voting stock of a corporation, or an affiliate or associate of the corporation and was the owner of 15% or more of the outstanding voting stock of a corporation at any time within three years prior to the time of determination of interested stockholder status; and any entity or person affiliated with or controlling or controlled by such entity or person.

 

These statutory provisions could delay or frustrate the removal of incumbent directors or a change in control of our company. They could also discourage, impede, or prevent a merger, tender offer, or proxy contest, even if such event would be favorable to the interests of stockholders.

 

Certificate of Incorporation and Bylaw Provisions

 

Our certificate of incorporation and bylaws contain provisions that could have the effect of discouraging potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. In particular, the charter documents, as applicable, among other things:

 

-provide our board of directors with the ability to alter our bylaws by unanimous vote without stockholder approval; and
-provide that vacancies on our board of directors may be filled by a majority of directors in office, although less than a quorum.

 

Such provisions may have the effect of discouraging a third-party from acquiring us, even if doing so would be beneficial to our stockholders. These provisions are intended to enhance the likelihood of continuity and stability in the composition of our board of directors and in the policies formulated by them, and to discourage some types of transactions that may involve an actual or threatened change in control of our company. These provisions are designed to reduce our vulnerability to an unsolicited acquisition proposal and to discourage some tactics that may be used in proxy fights. We believe that the benefits of increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company outweigh the disadvantages of discouraging such proposals because, among other things, negotiation of such proposals could result in an improvement of their terms.

 

However, these provisions could have the effect of discouraging others from making tender offers for our shares that could result from actual or rumored takeover attempts. These provisions also may have the effect of preventing changes in our management.

 

Limitation on Liability and Indemnification of Directors and Officers

 

Our charter documents limit the liability of our directors and officers. Our charter documents state that we shall indemnify, in accordance with and to the full extent now or hereafter permitted by law, any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative, or investigative (including, without limitation, an action by or in the right of the company), by reason of his or her acting as a director or officer of the company (or a director or officer serving at the request of the company in any other capacity for or on behalf of the company) against any expenses (including attorneys’ fees and costs, judgments, fines, ERISA or other excise taxes, penalties and amounts paid in settlement) actually and reasonably incurred by such director or officer in respect thereof; provided, however, that, the company shall not be obligated to indemnify any such director or officer with respect to proceedings, claims, or actions initiated or brought voluntarily by such director and not by way of defense. Expenses that may be subject to indemnification hereunder shall be paid in advance of the final disposition of the action, suit, or proceeding to the full extent permitted by Delaware law subject to the company’s receipt of any undertaking required thereby. The provisions of this article of our charter documents shall be deemed to constitute a contract between us and each director or officer who serves in such capacity at any time while this article and the relevant provisions of Delaware law are in effect, and each such director or officer shall be deemed to be serving as such in reliance on the provisions of this article of the our charter documents, and any repeal of any such provisions or of such article of our charter documents shall not affect any rights or obligations then existing with respect to any state of facts then or theretofore existing or any action, suit or proceeding theretofore or thereafter brought or threatened based in whole or in part upon any such state of facts. If a claim under this article of our charter documents is not paid in full within 30 days after a written claim has been received by the company, the claimant may at any time thereafter bring suit against the company to recover the unpaid amount of the claim and, if successful in whole or in part, the claimant also shall be entitled to be paid the expense of prosecuting such claim. It shall be a defense to any such action (other than an action brought to enforce a claim for expenses incurred in defending any proceeding in advance of its final disposition where the required undertaking, if any, has been provided to the company) that the claimant has not met the standards of conduct that make it permissible under Delaware law for the company to indemnify the claimant for the amount claimed, but the burden of proving such defense shall be on the company. Neither the failure of the company to have made a determination prior to the commencement of such action that indemnification of the claimant is proper under the circumstances because the claimant has met the applicable standard of conduct set forth in the Delaware law, nor an actual determination by the company that the claimant has not met such standard of conduct shall be a defense to the action or create a presumption that the claimant has not met the applicable standard of conduct. The rights of indemnification and advancement provided by this article of our charter documents are not exclusive of any other right to indemnification or advancement provided by law, agreement or otherwise, and shall apply to actions, suits, or proceedings commenced after the date hereof, whether or not arising from acts or omissions occurring before or after the adoption hereof, and shall continue as to a person who has ceased to be a director or officer of the company and shall inure to the benefit of the heirs, executors and administrators of such a person.

 

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Insofar as the above described indemnification provisions permit indemnification of directors, officers, or persons controlling us for liability arising under the Securities Act, we understand that in the opinion of the SEC, this indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

 

There is no pending litigation or proceeding involving any of our directors or officers as to which indemnification is required or permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification.

 

Exclusive Forum

 

Our bylaws provides that unless we consent in writing to the selection of an alternative forum, the United States District Court for the District of Delaware or if the United States District Court does not have jurisdiction, the Court of Chancery of the State of Delaware, shall, be the sole and exclusive forum for any (i) derivative action or proceeding brought on our behalf, (ii) action asserting a claim of breach of a fiduciary duty owed by any director, officer, or other employee to us or our stockholders; (iii) action asserting a claim arising pursuant to any provision of the DGCL, our certificate of incorporation or bylaws (as either may be amended from time to time); or (iv) action asserting a claim governed by the internal affairs doctrine.

 

The foregoing exclusive forum provision does not apply to actions brought to enforce any liability or duty created by the Securities Act or Exchange Act, or any other claim or cause of action for which the federal courts have exclusive jurisdiction. Although these provisions are expected to benefit us by providing increased consistency in the application of applicable law in the types of lawsuits to which they apply, the provisions may have the effect of discouraging lawsuits against directors and officers, may increase the costs to bring a claim, and limit your ability to bring a claim in a judicial forum that you find more favorable. The enforceability of similar choice of forum provisions in other companies’ charter documents have been challenged in legal proceedings and there is uncertainty as to whether a court would enforce such provisions. In addition, investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. It is possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained in our bylaws are inapplicable or unenforceable in such action.

 

Authorized but Unissued Shares

 

Our authorized but unissued shares of common stock will be available for future issuance without your approval. We may use additional shares for a variety of purposes, including future offerings to raise additional capital, to fund acquisitions and as employee compensation. The existence of authorized but unissued shares of common stock could render it more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.

 

Transfer Agent and Registrar

 

We have retained ClearTrust as the transfer agent and registrar for our common stock and Warrants.

 

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SHARES ELIGIBLE FOR FUTURE SALE

 

General

 

Prior to this offering, there was no established public trading market for our securities. Even if our application to list our common stock and Warrants on Nasdaq Capital Market is approved, we cannot assure you that a significant public market for our securities will develop or be sustained following this offering. Future sales of substantial amounts of our securities (including common stock issued on the exercise of options and Warrants) in the public market, or the perception that such sales could occur, could adversely affect prevailing market prices as well as our ability to raise equity capital in the future.

 

Upon completion of this offering and no exercise of the Warrants or the Underwriter’s Warrants, we will have 6,029,707 shares of common stock issued and outstanding (or 6,392,610 shares of common stock, if the underwriters exercise in full the overallotment option).

 

The securities sold in this offering will be freely tradable without further restriction or registration under the Securities Act, except for any shares held by our “affiliates” as that term is defined in Rule 144 under the Securities Act. The remaining outstanding shares of our common stock will be deemed “restricted securities” or “control securities” under the Securities Act. Subject to certain contractual restrictions, including the lock-up agreements described below, restricted securities and control securities may be sold in the public market only if (i) they have been registered or (ii) they qualify for an exemption from registration under Rule 144 or any other applicable exemption.

 

Rule 144

 

Under Rule 144, a person (or persons whose shares are aggregated) who is, or was at any time during the three months preceding a sale, deemed to be our “affiliate” would be entitled to sell within any three-month period a number of shares that does not exceed the greater of 1% of the then outstanding shares of our common stock, which would be approximately 60,297 shares of common stock immediately after this offering (assuming the underwriters do not elect to exercise their option to purchase additional shares), or the average weekly trading volume of our common stock on the during the four calendar weeks preceding such sale. Sales under Rule 144 are also subject to a six-month holding period and requirements relating to manner of sale and notice requirements and the availability of current public information about us. Upon completion of this offering and subject to the lock-up agreements described above, we expect that approximately 56.1% of our outstanding common stock (or 52.8% of our outstanding common stock if the underwriters exercise in full their option to purchase additional shares), will be subject to limitations on sales by affiliates under Rule 144 (assuming such affiliates do not purchase any shares in this offering).

 

Rule 144 also provides that a person who is not deemed to be, or have been, at any time during the three months preceding a sale, our affiliate, and who has for at least six months beneficially owned shares of our common stock that are restricted securities, will be entitled to freely sell such shares of our common stock subject only to the availability of current public information regarding us. A person who is not deemed to be, or have been, at any time during the three months preceding a sale, our affiliate, and who has beneficially owned for at least one year shares of our common stock that are restricted securities, will be entitled to freely sell such shares of our common stock under Rule 144 without regard to the current public information requirements of Rule 144.

 

2022 Stock Option Plan

 

On February 3, 2022, we adopted our 2022 Stock Option Plan, which provides for the grant of incentive stock options within the meaning of Section 422 of the Code, to our employees and any parent and subsidiary corporation’s employees, and for the grant of non-statutory stock options, restricted stock and other stock awards to our employees, directors and certain service providers and the employees and service providers of any parent and subsidiary corporation. A total of 1,666,667 shares of our common stock are reserved for issuance under the 2022 Stock Option Plan. (See “Description of Securities—Stock Options.”)

 

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2022 Restricted Stock Plan

 

On February 3, 2022, we adopted our 2022 Restricted Stock Plan which provides for the grant of common stock awards and performance awards to our officers, directors, and key employees and of our subsidiary corporations. A total of 1,666,667 shares of our common stock are reserved for issuance under the 2022 Restricted Stock Plan. (See “Description of Securities—Restricted Stock.”)

 

To date, pursuant to our 2022 Stock Option Plan, we have issued to our employees, officers, and directors 25,000 options to purchase shares of our common stock. The issuance of the above securities was deemed to be exempt from registration under the Securities Act in reliance upon Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder, or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering or pursuant to benefit plans and contracts relating to compensation as provided under Rule 701. Individuals who purchased securities as described above represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were affixed to the share certificates issued in such transactions.

 

The foregoing transaction did not involve any underwriters, underwriting discounts or commissions or any public offering.

 

Lock-Up Agreements

 

Pursuant to certain “lock-up” agreements, our executive officers, directors and holders of 10% or more of our outstanding common stock, have agreed, subject to limited exceptions, without the prior written consent of the underwriter, not to directly or indirectly, offer, pledge, sell, contract to sell, grant, lend, or otherwise transfer or dispose of, directly or indirectly, our common stock or any securities convertible into or exercisable or exchangeable for our common stock, enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of such securities, for a period of 180 days from the date of this prospectus. (See “Underwriting.”)

 

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CERTAIN MATERIAL FEDERAL INCOME TAX CONSIDERATIONS

 

The following is a summary of certain material United States federal income tax consequences to you of the acquisition, ownership, and disposition of shares of our common stock and Warrants offered pursuant to this prospectus and any common stock received upon the exercise of the Warrants (collectively, the “securities”). This discussion is not a complete analysis of all of the potential United States federal income tax consequences relating thereto, and, except as otherwise specifically provided herein, it does not address any estate and gift tax consequences or any tax consequences arising under any state, local or foreign tax laws, or any other United States federal tax laws. This discussion is based on the Code, Treasury Regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the Internal Revenue Service (the “IRS”), all as in effect as of the date of this prospectus. These authorities may change, possibly retroactively, resulting in United States federal income tax consequences different from those discussed below. No ruling has been or will be sought from the IRS with respect to the matters discussed below, and there can be no assurance that the IRS will not take a contrary position regarding the tax consequences of the acquisition, ownership, or dispositio