As filed with the Securities and Exchange Commission on November 30, 2023
Registration No. 333-
Delaware | | | 11-3713499 |
(State or jurisdiction | | | (I.R.S. Employer |
of incorporation or organization) | | | 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 establish and expand sales of our women-specific medical products and develop and commercialize additional products; |
• | our ability to commercialize or obtain regulatory approvals 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 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 United States 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; |
• | our ability to maintain compliance with Nasdaq’s continued listing requirements; and |
• | our expectations about market trends. |
Name of Selling Stockholder | | | Number of shares of Common Stock Beneficially Owned Prior to Offering | | | Maximum Number of shares of Common Stock to be Sold Pursuant to this Prospectus | | | Number of shares of Common Stock of Owned After Offering |
PharmaCyte Biotech, Inc. | | | 4,327,759 | | | 13,220,339(1) | | | 0 |
Iroquois Master Fund Ltd. | | | 1,080,316 | | | 1,586,440(2) | | | 0 |
Iroquois Capital Investment Group LLC | | | 1,057,628 | | | 1,057,628(3) | | | 0 |
Special Opportunities I Series | | | 1,080,316 | | | 2,247,456(4) | | | 0 |
(1) | Represents (i) 4,745,763 shares of our common stock issuable to PharmaCyte Biotech, Inc. (“PharmaCyte”) upon conversion of the Convertible Notes or in satisfaction of accrued interest thereon, (ii) 4,237,288 shares of our common stock issuable to PharmaCyte upon exercise of the Series A Warrants, and (iii) 4,237,288 shares of our common stock issuable to PharmaCyte upon exercise of the Series B Warrants. The Convertible Notes and the Warrants are subject to a beneficial ownership limitation of 19.99%, which does not permit the selling shareholder to convert that portion of the Convertible Notes or to exercise that portion of the Warrants that would result in the selling shareholder and its affiliates owning, after exercise, a number of shares of our common stock in excess of the beneficial ownership limitation. The amounts and percentages in the third column of the table do not give effect to the 19.99% beneficial ownership limitation, if applicable. PharmaCyte is a publicly traded company, the board of directors and chief executive officer of which are identified in PharmaCyte’s filings with the SEC. To the best of our knowledge, no person has sole voting or sole investment power with respect to the shares of our common stock beneficially owned by PharmaCyte. |
(2) | Represents (i) 569,492 shares of our common stock issuable to Iroquois Master Fund, Ltd. (“IMF”) upon conversion of the Convertible Notes or in satisfaction of accrued interest thereon, (ii) 508,474 shares of our common stock issuable to IMF upon exercise of the Series A Warrants, and (iii) 508,474 shares of our common stock issuable to IMF upon exercise of the Series B Warrants. The Convertible Notes and the Warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit the selling shareholder to convert that portion of the Convertible Notes or to exercise that portion of the Warrants that would result in the selling shareholder and its affiliates owning, after exercise, a number of shares of our common stock in excess of the beneficial ownership limitation. The amounts and percentages in the third column of the table do not give effect to the 4.99% beneficial ownership limitation, if applicable. Iroquois Capital Management L.L.C. (“ICM”) is the investment manager of IMF. ICM has voting control and investment discretion over securities held by IMF. As Managing Members of ICM, Richard Abbe and Kimberly Page make voting and investment decisions on behalf of ICM in its capacity as investment manager to IMF. As a result of the foregoing, Mr. Abbe and Mrs. Page may be deemed to have beneficial ownership (as determined under Section 13(d) of the Securities Exchange Act of 1934, as amended) of the securities held by ICM and IMF. The principal business address of IMF is c/o Iroquois Capital Management, LLC, 2 Overhill Road, Suite 400, Scarsdale, NY 10583. his information is based solely on information provided by IMF on November 29, 2023. |
(3) | Represents (i) 379,662 shares of our common stock issuable to Iroquois Capital Investment Group (“ICIG”) upon conversion of the Convertible Notes or in satisfaction of accrued interest thereon, (ii) 338,983 shares of our common stock issuable to ICIG upon exercise of the Series A Warrants, and (iii) 338,983 shares of our common stock issuable to ICIG upon exercise of the Series B Warrants. The Convertible Notes and the Warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit the selling shareholder to convert that portion of the Convertible Notes or to exercise that portion of the Warrants that would result in the selling shareholder and its affiliates owning, after exercise, a number of shares of our common stock in excess of the beneficial ownership limitation. The amounts and percentages in the third column of the table do not give effect to the 4.99% beneficial ownership limitation, if applicable. Richard Abbe is the managing member of ICIG. Mr. Abbe has voting control and investment discretion over securities held by ICIG. As such, Mr. Abbe may be deemed to be the beneficial owner (as determined under Section 13(d) of the Securities Exchange Act of 1934, as amended) of the securities held by ICIG. The principal business address of ICIG is 2 Overhill Road, Suite 400, Scarsdale, NY 10583. This information is based solely on information provided by ICIG on November 29, 2023. |
(4) | Represents (i) 806,780 shares of our common stock issuable to Special Opportunities I Series (“SOIS”) upon conversion of the Convertible Notes or in satisfaction of accrued interest thereon, (ii) 720,338 shares of our common stock issuable to SOIS upon exercise of the Series A Warrants, and (iii) 720,338 shares of our common stock issuable to SOIS upon exercise of the Series B Warrants. The Convertible Notes and the Warrants are subject to a beneficial ownership limitation of 4.99%, which does not permit the selling shareholder to convert that portion of the Convertible Notes or to exercise that portion of the Warrants that would result in the selling shareholder and its affiliates owning, after exercise, a number of shares of our common stock in excess of the beneficial ownership limitation. The amounts and percentages in the third column of the table do not give effect to the 4.99% beneficial ownership limitation, if applicable. |
• | on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale; |
• | in the over-the-counter market; |
• | in transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
• | through the writing or settlement of options, whether such options are listed on an options exchange or otherwise; |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the shares 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; |
• | short sales made after the date the Registration Statement is declared effective by the SEC; |
• | broker-dealers may agree with a selling security holder to sell a specified number of such shares at a stipulated price per share; |
• | a combination of any such methods of sale; and |
• | 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, our Annual Report on Form 10-K/A as filed with the SEC on April 28, 2023, and our Annual Report on Form 10-K/A as filed with the SEC on July 24, 2023; |
• | our Quarterly Reports on Form 10-Q (i) for the quarter ended March 31, 2023 filed on May 11, 2023, (ii) for the quarter ended June 30, 2023 filed on August 10, 2023, and (iii) for the quarter ended September 30, 2023 filed on November 14, 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, June 21, 2023, June 26, 2023, July 27, 2023, August 3, 2023, August 10, 2023, September 6, 2023, September 27, 2023, October 3, 2023, October 11, 2023, November 15, 2023, November 21, 2023, and November 29, 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 | | | $2,640.43 |
Printing and engraving expenses | | | $3,000.00 |
Legal fees and expenses | | | $25,000.00 |
Accounting fees and expenses | | | $15,000.00 |
Miscellaneous | | | $4,359.57 |
Total | | | $50,000.00 |
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, 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 (the “April 2023 Public Offering”). |
(2) | On November 21, 2023, pursuant to a securities purchase agreement, we issued to certain accredited investors (a) unregistered convertible notes in the amount of $6,850,000.00, (b) unregistered warrants to purchase an aggregate of 5,805,083 shares of our common stock at an exercise price of $1.18 per share, and (c) unregistered warrants to purchase an aggregate of 5,805,083 shares of our common stock at an exercise price of $1.475 per share. |
Item 16. | Exhibits. |
Exhibit Number | | | Description of Exhibit |
| | Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc., incorporated by reference to Exhibit 3.1 of the registrant’s Form 8-K filed June 22, 2021 | |
| | Amended and Restated Bylaws of Femasys Inc., incorporated by reference to Exhibit 3.2 of the registrant’s Form 8-K filed June 22, 2021 | |
| | First Amendment to the Amended and Restated Bylaws of Femasys Inc., incorporated by reference to Exhibit 3.1 of the registrant’s Form 8-K filed March 30, 2023 | |
| | Description of the Registrant’s Securities, incorporated by reference to Exhibit 4.1 of the registrant’s Form 10-K filed March 24, 2022 | |
| | Form of Certificate of Common Stock, incorporated by reference to incorporated by reference to Exhibit 4.1 of the registrant’s Form S-1 filed May 14, 2021 | |
| | Form of April 2023 Pre-Funded Warrant, incorporated by reference to Exhibit 4.1 of the registrant’s Form 8-K filed April 20, 2023 | |
| | Form of April 2023 Common Stock Warrant, incorporated by reference to Exhibit 4.2 of the registrant’s Form 8-K filed April 20, 2023 | |
| | Form of April 2023 Placement Agent Warrant, incorporated by reference to Exhibit 4.3 of the registrant’s Form 8-K filed April 20, 2023 | |
| | Form of Convertible Note, incorporated by reference to Exhibit 10.2 of the registrant’s Form 8-K filed November 15, 2023 | |
| | Form of Series A Warrant, incorporated by reference to Exhibit 4.1 of the registrant’s Form 8-K filed November 15, 2023 | |
| | Form of Series B Warrant, incorporated by reference to Exhibit 4.2 of the registrant’s Form 8-K filed November 15, 2023 | |
| | Opinion of Dechert LLP | |
| | Femasys Inc. 2021 Equity Incentive Plan, and forms of agreements thereunder, incorporated by reference to Exhibit 10.3 of the registrant’s Form S-1 filed May 14, 2021 | |
| | Femasys Inc. 2021 Employee Stock Purchase Plan, incorporated by reference to Exhibit 10.4 of the registrant’s Form S-1 filed May 14, 2021 | |
| | Amended and Restated Employment Agreement, by and between Femasys Inc. and Kathy Lee-Sepsick, incorporated by reference to Exhibit 10.6 of the registrant’s Form S-1/A filed June 14, 2021 | |
| | Amended and Restated Employment Agreement, by and between Femasys Inc. and Daniel Currie, incorporated by reference to Exhibit 10.8 of the registrant’s Form S-1/A filed June 14, 2021 | |
| | Employment Agreement, dated February 15, 2010, by and between Femasys Inc. and Gary Thompson, incorporated by reference to Exhibit 10.9 of the registrant’s Form S-1/A filed June 14, 2021 | |
| | Femasys Inc. Non-Employee Director Compensation Policy, incorporated by reference to Exhibit 10.11 of the registrant’s Form S-1/A filed June 14, 2021 | |
| | Form of Indemnification Agreement between Femasys Inc. and its directors and officers, incorporated by reference to Exhibit 10.12 of the registrant’s Form S-1 filed May 14, 2021 | |
| | 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, incorporated by reference to Exhibit 10.1 of the registrant’s Form 10-Q filed November 12, 2021 | |
| | Employment Agreement, dated as of February 28, 2022, between Femasys Inc. and Dov Elefant, incorporated by reference to Exhibit 10.1 of the registrant’s Form 8-K filed February 24, 2022 | |
| | Form of Inducement Stock Option Agreement, incorporated by reference to Exhibit 10.2 of the registrant’s Form 8-K filed February 24, 2022 | |
| | Equity Purchase Agreement dated as of July 1, 2022, by and between Femasys Inc. and Piper Sandler & Co., incorporated by reference to Exhibit 1.2 of the registrant’s Form S-3 filed July 1, 2022 | |
| | Form of Securities Purchase Agreement dated April 18, 2023, between Femasys Inc. and the purchaser(s) party thereto, incorporated by reference to Exhibit 10.1 of the registrant’s Form 8-K filed April 20, 2023 |
Exhibit Number | | | Description of Exhibit |
| | Form of Securities Purchase Agreement dated November 14, 2023, between Femasys Inc. and the purchasers party thereto, incorporated by reference to Exhibit 10.1 of the registrant’s Form 8-K filed November 15, 2023 | |
| | Form of Registration Rights Agreement dated November 14, 2023, between Femasys Inc. and the other parties thereto, incorporated by reference to Exhibit 10.3 of the registrant’s Form 8-K filed November 15, 2023 | |
| | Form of Collaboration Agreement dated November 14, 2023, between Femasys Inc. and the other parties thereto, incorporated by reference to Exhibit 10.4 of the registrant’s Form 8-K filed November 15, 2023 | |
| | Consent of KPMG LLP | |
| | Consent of Dechert LLP (included in Exhibit 5.1) | |
| | Power of Attorney (included on signature page) | |
| | Filing Fee Table |
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 registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
(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) | 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. |
| | 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) | | | November 30, 2023 |
Kathy Lee-Sepsick | | | ||||
| | | | |||
/s/ Dov Elefant | | | Chief Financial Officer (principal financial and accounting officer) | | | November 30, 2023 |
Dov Elefant | | | ||||
| | | | |||
/s/ Charles Larsen | | | Chair of the Board of Directors | | | November 30, 2023 |
Charles Larsen | | | ||||
| | | | |||
/s/ Alistair Milnes | | | Director | | | November 30, 2023 |
Alistair Milnes | | | ||||
| | | | |||
/s/ Joshua Silverman | | | Director | | | November 30, 2023 |
Joshua Silverman | | | ||||
| | | | |||
/s/ Edward Uzialko, Jr. | | | Director | | | November 30, 2023 |
Edward Uzialko, Jr. | | |