ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
(Exact Name of Registrant as Specified in its Charter)
|
|
|
|
(State or other jurisdiction of incorporation or organization)
|
|
(IRS Employer Identification No.)
|
|
|
(
|
(Address of principal executive offices, including zip code)
|
|
(Registrant’s telephone number, including area code)
|
Title of each class
|
|
Trading Symbol(s)
|
|
Name of each exchange on which registered
|
|
|
|
|
|
Large accelerated filer
|
☐
|
Accelerated filer
|
☐
|
|
☒
|
Smaller reporting company
|
|
|
|
Emerging growth company
|
|
Auditor Firm PCAOB ID:
|
Auditor Name:
|
Auditor Location:
|
PART III
|
|
|
Item 10.
|
1
|
|
Item 11.
|
7
|
|
Item 12.
|
10
|
|
Item 13.
|
12
|
|
Item 14.
|
14
|
|
PART IV
|
|
|
Item 15.
|
14
|
|
|
16
|
Item 10. |
Directors, Executive Officers and Corporate Governance.
|
Name
|
|
Age
|
|
Position
|
|
Director Since
|
Class I Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alistair Milnes (1)(2)(6)
|
|
50
|
|
Director
|
|
June 2023
|
|
|
|
|
|
|
|
Edward Uzialko, Jr.(1)(2)
|
|
73
|
|
Director
|
|
August 2005
|
|
|
|
|
|
|
|
Class II Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charles Larsen(3)(4)(5)(7)
|
|
72
|
|
Chairperson
|
|
October 2015
|
|
|
|
|
|
|
|
Joshua Silverman(3)
|
|
54
|
|
Director
|
|
November 2023
|
|
|
|
|
|
|
|
Class III Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kathy Lee-Sepsick
|
|
56
|
|
Founder, President, Chief Executive Officer and Director
|
|
February 2004
|
(1) |
Member of our audit committee
|
(2) |
Member of our compensation committee
|
(3) |
Member of our nominating and corporate governance committee
|
(4) |
Chairperson of our audit committee
|
(5) |
Chairperson of our compensation committee
|
(6) |
Chairperson of our nominating and corporate governance committee
|
(7) |
Chairperson of the Board
|
Name
|
Fees
Earned or
Paid in
Cash
($)
|
Awards(1)
($)
|
All Other
Compensation
($)
|
Total
($)
|
||||||||||||
John Adams, Jr.(2)
|
20,968
|
—
|
—
|
20,968
|
||||||||||||
John Dyett(2)
|
30,636
|
—
|
—
|
30,636
|
||||||||||||
Keith Kendall(3)(4)
|
26,199
|
9,075
|
—
|
35,274
|
||||||||||||
Charles Larsen
|
108,928
|
3,938
|
—
|
112,866
|
||||||||||||
Alistair Milnes(3)
|
31,444
|
9,075
|
—
|
40,519
|
||||||||||||
Anne Morrissey(4)
|
42,603
|
3,938
|
—
|
46,541
|
||||||||||||
Wendy Perrow(4)
|
39,356
|
3,938
|
—
|
43,294
|
||||||||||||
Joshua Silverman(5)
|
5,000
|
12,958
|
—
|
17,958
|
||||||||||||
Edward Uzialko
|
41,967
|
3,938
|
—
|
45,905
|
(1) |
The values shown reflect the grant date fair value of the non-employee director stock option awards computed in accordance with FASB ASC, Topic 718. See Note 10 to the Annual Report on Form 10-K for the year
ended December 31, 2023, filed with the SEC on March 28, 2024, for a discussion on the relevant assumptions used in the calculation.
|
(2) |
Messrs. Adams and Dyett resigned from our Board in June 2023.
|
(3) |
Messrs. Kendall and Milnes joined our Board in June 2023.
|
(4) |
Mr. Kendall and Mss. Morrissey and Perrow resigned from our Board in November 2023.
|
(5) |
Mr. Silverman joined our Board in November 2023.
|
|
Annual
Retainer
|
|||
Board of Directors:
|
||||
Members
|
$
|
40,000
|
||
Additional retainer for non-executive chair, if any
|
$
|
35,000
|
||
Audit Committee:
|
||||
Members (other than chair)
|
$
|
9,000
|
||
Retainer for chair
|
$
|
20,000
|
||
Compensation Committee:
|
||||
Members (other than chair)
|
$
|
6,000
|
||
Retainer for chair
|
$
|
15,000
|
||
Nominating and Corporate Governance Committee:
|
||||
Members (other than chair)
|
$
|
5,000
|
||
Retainer for chair
|
$
|
10,000
|
Name
|
|
Age
|
|
Position
|
Kathy Lee-Sepsick
|
|
56
|
|
Founder, President and Chief Executive Officer and Director
|
Dov Elefant
|
|
56
|
|
Chief Financial Officer
|
Daniel Currie
|
|
60
|
|
Chief Operating Officer
|
Richard Spector
|
53
|
Chief Commercial Officer
|
||
Christine Thomas
|
|
51
|
|
Senior Vice President, Regulatory and Clinical Affairs
|
• |
appointing, compensating, retaining and overseeing the work of our independent auditor and any other registered public accounting firm engaged for the purpose of preparing or issuing an audit report or
related work or performing other audit, review or attest services for us;
|
• |
discussing with our independent auditor any audit problems or difficulties and management's response;
|
• |
pre-approving all audit and non-audit services provided to us by our independent auditor (other than those provided pursuant to appropriate preapproval policies established by the committee or exempt from
such requirement under SEC rules);
|
• |
reviewing and discussing our annual and quarterly financial statements with management and our independent auditor;
|
• |
discussing and overseeing our policies with respect to risk assessment and risk management, including cybersecurity risks; and
|
• |
establishing procedures for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls or auditing matters, and for the confidential and anonymous
submission by our employees of concerns regarding questionable accounting or auditing matters.
|
Item 11. |
Executive Compensation.
|
Name and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Awards(1)
($)
|
All other
compensation(2)
($)
|
Total
($)
|
|||||||||||||||
Kathy Lee-Sepsick
|
2023
|
500,000
|
270,000
|
214,751
|
34,674
|
1,019,425
|
|||||||||||||||
President and Chief Executive Officer
|
2022
|
423,296
|
—
|
205,403
|
30,280
|
658,979
|
|||||||||||||||
Daniel Currie
|
2023
|
389,000
|
124,480
|
82,265
|
34,674
|
630,419
|
|||||||||||||||
Chief Operating Officer
|
2022
|
322,373
|
—
|
153,133
|
30,280
|
505,686
|
|||||||||||||||
Dov Elefant(3)
|
2023
|
420,000
|
151,200
|
121,084
|
23,940
|
716,224
|
|||||||||||||||
Chief Financial Officer
|
2022
|
335,185
|
—
|
245,855
|
20,535
|
601,575
|
(1)
|
The values shown reflect the grant date fair value of the stock option awards computed in accordance with FASB ASC, Topic 718. See Note 10 to the Annual Report on Form 10-K for the year
ended December 31, 2023, filed with the SEC on March 28, 2024, for a discussion on the relevant assumptions used in the calculation.
|
(2)
|
Consists of paid family health benefits and 401K match.
|
(3)
|
Mr. Elefant was employed as of February 28, 2022.
|
• |
medical, dental and vision benefits;
|
• |
medical and dependent care flexible spending accounts;
|
• |
short-term and long-term disability insurance; and
|
• |
life insurance.
|
Name
|
|
Grant Date
|
|
|
Vesting
Commencement
Date
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
|
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
|
Option
Exercise
Price
($)
|
|
|
Option
Expiration
Date
|
||||||||||||||||||
Kathy Lee-Sepsick
|
|
03/18/2016
|
|
|
—
|
(1)
|
|
55,556
|
|
—
|
|
111,111
|
1.71
|
|
|
03/18/2026
|
||||||||||||||||
06/30/2017
|
|
|
06/01/2017
|
(2)
|
|
166,668
|
|
—
|
|
—
|
3.24
|
|
|
06/30/2027
|
||||||||||||||||||
12/13/2019
|
|
|
11/01/2019
|
(2) |
|
5,556
|
|
—
|
|
—
|
6.12
|
|
|
12/13/2029
|
||||||||||||||||||
|
01/26/2022
|
|
|
09/22/2023
|
(3) |
|
100,000
|
|
—
|
|
—
|
13.00
|
|
|
01/26/2032
|
|||||||||||||||||
|
07/03/2023
|
|
|
07/03/2023
|
(2)
|
|
0
|
|
270,400
|
|
—
|
0.49
|
|
|
07/03/2033
|
|||||||||||||||||
|
07/03/2023
|
|
|
07/03/2023
|
(4)
|
|
271,900
|
|
—
|
|
—
|
0.49
|
|
|
07/03/2033
|
|||||||||||||||||
Daniel Currie
|
|
03/18/2016
|
|
|
09/11/2015
|
(2)
|
|
5,556
|
|
—
|
|
—
|
1.71
|
|
|
03/18/2026
|
||||||||||||||||
06/30/2017
|
|
|
06/01/2017
|
(2)
|
|
27,778
|
|
—
|
|
—
|
3.24
|
|
|
06/30/2027
|
||||||||||||||||||
12/13/2019
|
|
|
11/01/2019
|
(2)
|
|
5,556
|
|
—
|
|
—
|
6.12
|
|
|
12/13/2029
|
||||||||||||||||||
|
01/25/2022
|
|
|
01/25/2022
|
(2)
|
|
5,000
|
|
15,000
|
|
—
|
3.03
|
|
|
01/25/2032
|
|||||||||||||||||
|
01/25/2022
|
|
|
(5)
|
|
—
|
|
___
|
|
40,000
|
3.03
|
|
|
01/25/2032
|
||||||||||||||||||
|
07/03/2023
|
|
|
07/03/2023
|
(2)
|
|
0
|
|
84,600
|
|
—
|
0.49
|
|
|
07/03/2033
|
|||||||||||||||||
|
07/03/2023
|
|
|
07/03/2023
|
(4)
|
|
124,800
|
|
—
|
|
—
|
0.49
|
|
|
07/03/2033
|
|||||||||||||||||
Dov Elefant
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
02/28/2022
|
|
|
02/28/2022
|
(2)
|
|
25,000
|
|
75,000
|
|
—
|
2.97
|
|
|
02/28/2032
|
||||||||||||||||||
|
07/03/2023
|
|
|
07/03/2023
|
(2)
|
|
0
|
|
105,200
|
|
—
|
0.49
|
|
|
07/03/2033
|
|||||||||||||||||
|
07/03/2023
|
|
|
07/03/2023
|
(4)
|
|
204,700
|
|
—
|
|
—
|
0.49
|
|
|
07/03/2033
|
(1) |
The stock option award provides for 55,556 awards to vest on the approval of an IDE application and
111,111 awards to vest on the PMA approval for FemBloc.
|
(2) |
The stock option award provides for 25% of the award to vest on each anniversary of the vesting commencement date (such that the award would fully vest on the fourth anniversary of the vesting commencement date), subject to the
recipient's continuous employment with us through the relevant vesting dates.
|
(3) |
The stock option award provides for 100,000 awards to vest on FDA de novo approval for FemaSeed. Vesting occurred on September 22, 2023.
|
(4) |
The stock option award
provides for 100% vesting upon grant.
|
(5) |
The stock option award provides for 5,000 awards to vest annually on each anniversary of the filing of the date of the FemaSeed de novo with FDA if such filing occurs during the year ended December 31, 2023 and for 5,000 awards to vest
annually on each anniversary of the filing of the date of the IDE submission to the FDA for FemBloc if such filing occurs during the year ended December 31, 2023, subject to the recipient's continuous employment with us through the relevant
vesting dates. The options related to FemBloc began vesting June 26, 2023, and the options related to FemaSeed began vesting September 22, 2023.
|
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
• |
each person or group of affiliated persons known by us to beneficially own more than 5% of our common stock;
|
• |
each of our named executive officers;
|
• |
each of our directors; and
|
• |
all of our executive officers and directors as a group.
|
|
Number of
Shares
Beneficially
Owned (#)
|
Percentage
of
Shares
Beneficially
Owned (%)
|
||||||
Name and Address of Beneficial Owner
5% Stockholders:
PharmaCyte Biotech, Inc.(1)
|
5,551,707
|
19.99
|
%
|
|||||
Named executive officers and directors:
|
||||||||
Kathy Lee-Sepsick(2)
|
949,681
|
4.16
|
% | |||||
Daniel Currie(3)
|
263,322
|
1.18
|
% | |||||
Dov Elefant(4)
|
254,700
|
1.13
|
% | |||||
Charles Larsen(5)
|
48,476
|
*
|
||||||
Alistair Milnes
|
5,667
|
*
|
||||||
Joshua Silverman
|
—
|
*
|
||||||
Edward Uzialko, Jr.(6)
|
1,234,406
|
5.55
|
%
|
|||||
All executive officers and directors as a group (10 individuals)
|
2,768,752
|
11.88
|
% |
* |
Less than 1%.
|
(1) |
As reported in Schedule 13D filed with the SEC dated November 22, 2023 by PharmaCyte Biotech, Inc.
As described in the Schedule 13D, includes (i) 4,237,288 shares of common stock issuable upon conversion of a 6.0% senior unsecured convertible note due 2025 (as may be adjusted from time to time), which conversion is subject to a 19.99%
beneficial ownership limitation, (ii) Series A warrants immediately exercisable for 4,237,288 shares of common stock, subject to a 19.99% beneficial ownership limitation, and (iii) Series B warrants immediately exercisable for 4,237,288
shares of common stock, subject to a 19.99% beneficial ownership limitation. The shareholder may change its beneficial ownership limitation upon giving notice to us, which such change will not be effective until the 61st day after the
notice is delivered to us. As a consequence of this beneficial ownership conversion cap and related limitation on the conversion and exercise of the convertible note and warrants, the beneficial ownership of this shareholder is limited as
indicated in the table. The address of PharmaCyte Biotech, Inc. is 3960 Howard Hughes Parkway, Suite 500, Las Vegas, Nevada 89169.
|
(2) |
Consists of 277,778 shares owned, 72,223 shares held by the Lee-Sepsick Family Trust, and 599,680 shares issuable upon exercise of outstanding stock options that are exercisable withing 60 days of April 25,
2024, of which all are vested as of such date.
|
(3) |
Consists of 66,667 shares owned, 22,223 shares held by the Currie Family Trust, 742 shares held by Mr. Currie’s spouse, and 173,690 shares issuable upon exercise of outstanding stock options that are
exercisable withing 60 days of April 25, 2024, of which all are vested as of such date.
|
(4) |
Consists of 254,700 shares issuable upon exercise of outstanding stock options that are exercisable withing 60 days of April 25, 2024, of which all are vested as of such date.
|
(5) |
Consists of 31,476 shares owned and 8,500 shares issuable upon exercise of outstanding stock options that are exercisable withing 60 days of April 25, 2024, of which all are vested as of such date.
|
(6) |
Consists of 1,187,231 shares owned, 30,175 shares owned by Mr. Uzialko’s spouse and 8,500 shares issuable upon exercise of outstanding stock options that are exercisable withing 60 days of April 25, 2024, of
which all are vested as of such date.
|
|
(a)
|
(b)
|
(c)
|
|||||||||
Plan Category
|
Number
of securities
to be issued
upon exercise
of outstanding
securities
|
Weighted-
average
exercise price
of outstanding
securities
($)
|
Number of securities
remaining available for
future issuance under
equity compensation
plans (excluding
securities reflected in
column(a))
|
|||||||||
Equity compensation plans approved by stockholders 2021 Plan(1)
|
1,547,042
|
1.63
|
1,016,501
|
|||||||||
Equity compensation plans not approved by stockholders 2015 Plan
|
554,988
|
3.03
|
n/a
|
|||||||||
Inducement Awards
|
150,000
|
2.42
|
n/a
|
|||||||||
Total
|
2,252,030
|
1,016,501
|
(1) |
Includes our 2021 Plan and our ESPP. For a description of these plans, refer to Note 10 to the historical financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31,
2023.
|
Item 13. |
Certain Relationships and Related Transactions, and Director Independence.
|
Item 14. |
Principal Accounting Fees and Services.
|
|
Year Ended December 31,
|
|||||||
|
2023
|
2022
|
||||||
Audit fees(1)
|
$
|
479,012
|
$
|
411,266
|
||||
Tax fees(2)
|
48,300
|
34,600
|
||||||
Total fees
|
$
|
527,312
|
$
|
445,866
|
(1) |
Consists of services rendered in connection with the audit of our financial statements, including audited financial statements included in our Form 10-K filing and presented in our Registration Statement on
Form S-1 and on Form S-3, review of the interim financial statements and services normally provided in connection with regulatory filings.
|
(2) |
Consists of fees billed for professional services in connection with the preparation of our tax returns, including the services for our research and development tax credit analysis.
|
Item 15. |
Exhibits.
|
Exhibit
Number
|
Description of Document
|
Schedule/Form
|
Exhibit
|
Filing Date
|
|
|
|
|
|
Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc.
|
Form 8-K
|
3.1
|
June 22, 2021
|
|
Amended and Restated Bylaws of Femasys Inc.
|
Form 8-K
|
3.2
|
June 22, 2021
|
|
First Amendment to the Amended and Restated Bylaws of Femasys Inc.
|
Form 8-K
|
3.1
|
March 30, 2023
|
|
Description of the Registrant’s Securities
|
Form 10-K
|
4.1
|
March 24, 2022
|
|
Form of Certificate of Common Stock
|
Form S-1
|
4.1
|
May 14, 2021
|
|
Form of indenture
|
Form S-3
|
4.3
|
July 1, 2022
|
|
Form of Pre-Funded Warrant
|
Form 8-K
|
4.1
|
April 20, 2023
|
|
Form of Common Stock Warrant
|
Form 8-K
|
4.2
|
April 20, 2023
|
|
Form of Placement Agent Warrant
|
Form 8-K
|
4.3
|
April 20, 2023
|
|
Form of Series A Warrant
|
Form 8-K
|
4.1
|
November 15, 2023
|
|
Form of Series B Warrant
|
Form 8-K
|
4.2
|
November 15, 2023
|
|
Femasys Inc. 2021 Equity Incentive Plan, and forms of agreements thereunder
|
Form S-1
|
10.3
|
May 14, 2021
|
|
Femasys Inc. 2021 Employee Stock Purchase Plan
|
Form S-1
|
10.4
|
May 14, 2021
|
|
Amended and Restated Employment Agreement, by and between Femasys Inc. and Kathy Lee-Sepsick
|
Form S-1/A
|
10.6
|
June 14, 2021
|
Amended and Restated Employment Agreement, by and between Femasys Inc. and Daniel Currie
|
Form S-1/A
|
10.8
|
June 14, 2021
|
|
Femasys Inc. Non-Employee Director Compensation Policy
|
Form S-1/A
|
10.11
|
June 14, 2021
|
|
Form of Indemnification Agreement between Femasys Inc. and its directors and officers
|
Form S-1
|
10.12
|
May 14, 2021
|
|
Employment Agreement, dated as of February 28, 2022, between Femasys Inc. and Dov Elefant
|
Form 8-K
|
10.1
|
February 24, 2022
|
|
Form of Inducement Stock Option Agreement
|
Form 8-K
|
10.2
|
February 24, 2022
|
|
Sales Agreement dated as of July 1, 2022, by and between Femasys Inc. and Piper Sandler & Co.
|
Form S-3
|
1.2
|
July 1, 2022
|
|
Form of Purchase Agreement
|
Form 8-K
|
10.1
|
November 15, 2023
|
|
Form of Convertible Note
|
Form 8-K
|
10.2
|
November 15, 2023
|
|
Form of Registration Rights Agreement
|
Form 8-K
|
10.3
|
November 15, 2023
|
|
Form of Collaboration Agreement
|
Form 8-K
|
10.4
|
November 15, 2023
|
|
Consent of KPMG LLP
|
Form 10-K
|
23.1
|
March 28, 2024
|
|
Power of Attorney (included on signature page)
|
Form 10-K
|
March 28, 2024
|
||
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
Form 10-K
|
31.1
|
March 28, 2024
|
|
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
Form 10-K
|
31.2
|
March 28, 2024
|
|
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
|
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Form 10-K
|
32.1
|
March 28, 2024
|
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Form 10-K
|
32.2
|
March 28, 2024
|
|
Clawback Policy
|
Form 10-K
|
97.1
|
March 28, 2024
|
|
101.INS*
|
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
|
|
|
|
101.SCH*
|
Inline XBRL Taxonomy Extension Schema Document
|
|
|
|
101.LAB*
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE*
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
104*
|
Cover Page Interactive Data File (formatted as inline XRBL and contained in Exhibit 101)
|
|
|
|
FEMASYS INC.
|
|
|
Dated: April 26, 2024
|
By: /s/ Kathy Lee-Sepsick
|
Kathy Lee-Sepsick
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
By: /s/ Kathy Lee-Sepsick
|
|
|
|
April 26, 2024
|
Kathy Lee-Sepsick
|
|
President, Chief Executive Officer and Director (principal executive officer)
|
|
|
|
|
|
|
|
By: /s/ Dov Elefant
|
|
|
|
April 26, 2024
|
Dov Elefant
|
|
Chief Financial Officer (principal financial and accounting officer)
|
|
|
|
|
|
|
|
By: /s/ Charles Larsen
|
|
|
|
April 26, 2024
|
Charles Larsen
|
|
Chair of the Board of Directors
|
|
|
|
|
|
|
|
By: /s/ Alistair Milnes
|
|
|
|
April 26, 2024
|
Alistair Milnes
|
|
Director
|
|
|
|
|
|
|
|
By: /s/ Joshua Silverman
|
|
|
|
April 26, 2024
|
Joshua Silverman
|
|
Director
|
|
|
|
|
|
|
|
By: /s/ Edward Uzialko,
Jr.
|
|
|
|
April 26, 2024
|
Edward Uzialko, Jr.
|
|
Director
|
|
|