As filed with the Securities and Exchange Commission on June 23, 2023
Registration No. 333-
Delaware | | | 3841 | | | 11-3713499 |
(State or jurisdiction | | | (Primary Standard Industrial | | | (I.R.S. Employer |
of incorporation or organization) | | | Classification Code Number) | | | Identification No.) |
Large accelerated filer ☐ | | | Accelerated filer ☐ |
Non-accelerated filer ☒ | | | Smaller reporting company ☒ |
Emerging growth company ☒ | | |
• | being permitted 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 in this prospectus; |
• | not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended; |
• | reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and |
• | exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. |
• | our ability to develop and advance our current product candidates and programs into, and successfully initiate and complete, clinical trials; |
• | the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; |
• | our ability to enroll subjects in the clinical trials for our product candidates in order to advance the development thereof on a timely basis; |
• | our ability to obtain additional financing to fund the clinical development of our products and fund operations; |
• | estimates regarding the total addressable market for our product candidates; |
• | competitive companies and technologies in our industry; |
• | our ability to obtain U.S Food and Drug Administration (FDA) approval for our permanent birth control system, ability to gain FDA grant of a de novo classification request for our intrauterine artificial insemination product, expand sales of our women-specific medical products and develop and commercialize additional products; |
• | our ability to commercialize or obtain regulatory approvals, grants of de novo classification requests or 510(k) clearance for our product candidates, or the effect of delays in commercializing or obtaining regulatory authorizations; |
• | our business model and strategic plans for our products, technologies and business, including our implementation thereof; |
• | commercial success and market acceptance of our product candidates; |
• | our ability to achieve and maintain adequate levels of coverage or reimbursement for our FemBloc system or any future products we may seek to commercialize; |
• | our ability to manufacture our products and product candidates in compliance with applicable laws, regulations and requirements and to oversee third-party suppliers, service providers and vendors in the performance of any contracted activities in accordance with applicable laws, regulations and requirements; |
• | adverse developments affecting the financial services industry; |
• | the impact of the COVID-19 pandemic on our business, financial condition, results of operations, and prospects; |
• | our ability to accurately forecast customer demand for our product candidates, and manage our inventory; |
• | our ability to build, manage and maintain our direct sales and marketing organization, and to market and sell our permanent birth control system, artificial insemination product and women-specific medical product solutions in markets in and outside of the United States (U.S.); |
• | our ability to obtain necessary financing for the Company and maintain adequate resources to fund our operations; |
• | our ability to hire and retain our senior management and other highly qualified personnel; |
• | FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the U.S. and international markets; |
• | the timing or likelihood of regulatory filings and approvals or clearances; |
• | our ability to establish and maintain intellectual property protection for our product candidates and our ability to avoid claims of infringement; |
• | the volatility of the trading price of our common stock; and |
• | our expectations about market trends. |
• | before such date, our board of directors approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; |
• | upon closing 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 began, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned by (1) persons who are directors and also officers and (2) 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 after such date, the business combination is approved by our board of directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least sixty-six and two-thirds percent (66 2∕3%) of the outstanding voting stock that is not owned by the interested stockholder. |
• | 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 or 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 loss, advances, guarantees, pledges or other financial benefits by or through the corporation. |
Name of Selling Stockholder | | | Shares Beneficially Owned Before Offering | | | Number of Shares Being Offered | | | Shares Beneficially Owned After Offering | |||
| Number of Shares | | | Percentage of Class(1) | ||||||||
Armistice Capital LLC(2) | | | 6,393,444 | | | 3,196,722(3) | | | 3,196,722 | | | 21.21%(4) |
Michael Vasinkevich(5) | | | 122,994 | | | 122,994(6) | | | 0 | | | * |
Noam Rubinstein(5) | | | 42,197 | | | 42,197(7) | | | 0 | | | * |
Michael Mirsky(5) | | | 18,221 | | | 18,221(8) | | | 0 | | | * |
Craig Schwabe(5) | | | 6,473 | | | 6,473(9) | | | 0 | | | * |
Charles Worthman(5) | | | 1,918 | | | 1,918(10) | | | 0 | | | * |
* | Less than 1% |
(1) | Based on 13,514,295 shares of our common stock issued and outstanding as of June 8, 2023. In computing the percentage ownership of a selling stockholder, we deemed outstanding shares of common stock subject to Warrants held by that selling stockholder that are exercisable within 60 days of June 8, 2023. We did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of any other selling stockholder. |
(2) | The securities are held by Armistice Capital Master Fund Ltd. The securities may be deemed to be beneficially owned by (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of Armistice Capital Master Fund Ltd.; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation |
(3) | Represents 3,196,722 shares of common stock issuable upon the exercise of the Common Warrants, which are immediately exercisable. Does not take into account beneficial ownership limitations preventing Armistice Capital Master Fund Ltd. from exercising any of the Common Warrants to the extent following such exercise its beneficial ownership would exceed 4.99%. |
(4) | Does not take into account beneficial ownership limitations preventing Armistice Capital Master Fund Ltd. from exercising any of its warrants to the extent following such exercise its beneficial ownership would exceed 4.99%. |
(5) | The selling stockholder is affiliated with Wainwright, a registered broker-dealer and the placement agent for the April 2023 Offering with a registered address of H.C. Wainwright & Co., LLC, 430 Park Ave, 3rd Floor, New York, NY 10022, and, as a designee of Wainwright, received as compensation Placement Agent Warrants in the transactions described under “The Company – April 2023 Concurrent Registered Direct Offering and Private Placement.” The selling stockholder acquired the Placement Agent warrants in the ordinary course of business and, at the time the Placement Agent Warrants were acquired, the selling stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities. |
(6) | Represents 122,994 shares of common stock issuable upon the exercise of Placement Agent Warrants, which are immediately exercisable. The Placement Agent Warrants are only exercisable to the extent that Michael Vasinkevich and his affiliates beneficially own no more than 4.99% of the outstanding common stock after exercise. |
(7) | Represents 42,197 shares of common stock issuable upon the exercise of Placement Agent Warrants, which are immediately exercisable. The Placement Agent Warrants are only exercisable to the extent that Noam Rubinstein and his affiliates beneficially own no more than 4.99% of the outstanding common stock after exercise. |
(8) | Represents 18,221 shares of common stock issuable upon the exercise of Placement Agent Warrants, which are immediately exercisable. The Placement Agent Warrants are only exercisable to the extent that Michael Mirsky and his affiliates beneficially own no more than 4.99% of the outstanding common stock after exercise. |
(9) | Represents 6,473 shares of common stock issuable upon the exercise of Placement Agent Warrants, which are immediately exercisable. The Placement Agent Warrants are only exercisable to the extent that Craig Schwabe and his affiliates beneficially own no more than 4.99% of the outstanding common stock after exercise. |
(10) | Represents 1,918 shares of common stock issuable upon the exercise of Placement Agent Warrants, which are immediately exercisable. The Placement Agent Warrants are only exercisable to the extent that Charles Worthman and his affiliates beneficially own no more than 4.99% of the outstanding common stock after exercise. |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | underwritten transactions; |
• | block trades (which may involve a cross trade) in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | settlement of short sales; |
• | in transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such securities at a stipulated price per security; |
• | through the distribution of shares by any selling stockholder to its partners, members or stockholders; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | a combination of any such methods of sale; or |
• | any other method permitted pursuant to applicable law. |
• | our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 30, 2023 and our Annual Report on Form 10-K/A as filed with the SEC on April 28, 2023; |
• | our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed on May 11, 2023; |
• | our Current Reports on Form 8-K filed with the SEC on March 13, 2023, March 30, 2023, April 18, 2023, April 20, 2023, May 4, 2023, June 2, 2023, June 8, 2023, June 15, 2023 and June 21, 2023; and |
• | the description of our common stock contained in our registration statement on Form 8-A filed with the SEC on June 14, 2021, including any amendments or reports filed for the purpose of updating such description. |
Item 13. | Other Expenses of Issuance and Distribution. |
Securities and Exchange Commission registration fee | | | $221.58 |
NASDAQ listing fee | | | $5,000.00 |
Printing and engraving expenses | | | $3,000.00 |
Legal fees and expenses | | | $25,000.00 |
Accounting fees and expenses | | | $5,000.00 |
Miscellaneous | | | $1,778.42 |
Total | | | $40,000.00 |
Item 14. | Indemnification of Directors and Officers. |
Item 15. | Recent Sales of Unregistered Securities. |
(1) | On April 20, 2023, pursuant to a securities purchase agreement and concurrent to the April 2023 Offering, we issued unregistered common warrants to certain accredited investors to purchase an aggregate of 3,196,722 shares of our common stock at an exercise price of $1.095 per share. |
Item 16. | Exhibits. |
Exhibit Number | | | Description of Exhibit |
| | Form of Underwriting Agreement | |
| | Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc. | |
| | Amended and Restated Bylaws of Femasys Inc. | |
| | First Amendment to the Amended and Restated Bylaws of Femasys Inc. | |
| | Description of the Registrant’s Securities | |
| | Form of Certificate of Common Stock | |
| | Form of indenture | |
| | Opinion of Dechert LLP | |
| | Femasys Inc. 2021 Equity Incentive Plan, and forms of agreements thereunder | |
| | Femasys Inc. 2021 Employee Stock Purchase Plan | |
| | Amended and Restated Employment Agreement, by and between Femasys Inc. and Kathy Lee-Sepsick | |
| | Amended and Restated Employment Agreement, by and between Femasys Inc. and Daniel Currie | |
| | Employment Agreement, dated February 15, 2010, by and between Femasys Inc. and Gary Thompson | |
| | Femasys Inc. Non-Employee Director Compensation Policy | |
| | Form of Indemnification Agreement between Femasys Inc. and its directors and officers | |
| | Master Services Agreement and Statement of Work for consulting services, effective August 12, 2021, by and between Femasys Inc. and Bespoke Medical Affairs Solutions, LLC | |
| | Employment Agreement, dated as of February 28, 2022, between Femasys Inc. and Dov Elefant | |
| | Form of Inducement Stock Option Agreement | |
| | Sales Agreement dated as of July 1, 2022, by and between Femasys Inc. and Piper Sandler & Co. | |
| | Consent of KPMG LLP | |
| | Consent of Dechert LLP (included in Exhibit 5.1) | |
| | Power of Attorney (included on signature page) | |
| | Filing Fee Table |
* | Filed herewith. |
Item 17. | Undertakings. |
(a)(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | to include any prospectus required by section 10(a)(3) of the Securities Act of 1933; |
(ii) | to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, an increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; |
(iii) | to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement. |
(2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser: |
(i) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), 424(b)(5), or 424(b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), 415(a)(1)(vii), or 415(a)(1)(x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the |
(5) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
(i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
(iii) | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
(iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(b) | The undersigned registrant hereby further undertakes that, for the purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(c) | Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. |
| | FEMASYS INC. | ||||
| | | | |||
| | By: | | | /s/ Kathy Lee-Sepsick | |
| | | | Kathy Lee-Sepsick President and Chief Executive Officer |
Signature | | | Title | | | Date |
| | | | |||
/s/ Kathy Lee-Sepsick | | | President and Chief Executive Officer (principal executive officer) | | | June 23, 2023 |
Kathy Lee-Sepsick | | |||||
| | | | |||
/s/ Dov Elefant | | | Chief Financial Officer (principal financial and accounting officer) | | | June 23, 2023 |
Dov Elefant | | |||||
| | | | |||
/s/ Charles Larsen | | | Chair of the Board of Directors | | | June 23, 2023 |
Charles Larsen | | |||||
| | | | |||
/s/ Keith Kendall | | | Director | | | June 23, 2023 |
Keith Kendall | | |||||
| | | | |||
/s/ Alistair Milnes | | | Director | | | June 23, 2023 |
Alistair Milnes | | |||||
| | | | |||
/s/ Anne Morrissey | | | Director | | | June 23, 2023 |
Anne Morrissey | | |||||
| | | | |||
/s/ Wendy Perrow | | | Director | | | June 23, 2023 |
Wendy Perrow | | |||||
| | | | |||
/s/ Edward Uzialko, Jr | | | Director | | | June 23, 2023 |
Edward Uzialko, Jr. | |