UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
September 30,
2025
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________to____________
Commission file number:
001-40492
.
|
|
|
|
|
|
(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)
|
|
(Zip Code)
|
|
(
|
|
|
|
(Registrant’s telephone number, including area code)
|
|
|
|
N/A
|
|
|
|
(Former name, former address and former fiscal year, if changed since last report)
|
|
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
|
Trading symbol
|
|
Name of each exchange on which
Registered
|
|
|
|
|
|
The
|
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes
☑
No
☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes
☑
No
☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
Large accelerated filer
☐
|
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 13(a) of the Exchange Act.
☑
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
☐
No
☑
The Registrant had
58,479,824
shares of common stock, $0.001 par
value, outstanding as of November 13, 2025.
|
|
TABLE OF CONTENTS
|
|
|
|
|
Page
|
|
|
|
|
|
Part I. Financial Information
|
||
|
Item 1
|
5
|
|
|
|
5
|
|
|
|
7
|
|
|
|
8
|
|
|
|
10
|
|
|
|
11
|
|
|
Item 2
|
21
|
|
|
Item 3
|
29
|
|
|
Item 4
|
30
|
|
|
|
||
|
Part II. Other Information
|
||
|
Item 1
|
30
|
|
|
Item 1A
|
30
|
|
|
Item 2
|
33
|
|
|
Item 3
|
33
|
|
|
Item 4
|
33
|
|
|
Item 5
|
33
|
|
|
Item 6
|
34
|
|
|
|
||
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning:
• our ability to obtain additional financing to fund commercialization of our products and fund our operations;
• our ability to obtain additional financing to fund the U.S. clinical development of our U.S. product candidate FemBloc® permanent birth control;
• our ability to obtain U.S. Food and Drug Administration (FDA) approval for our U.S. product candidate, FemBloc, for permanent birth control;
• our ability to successfully grow sales of FemaSeed® intratubal insemination in the U.S.;
• our ability to successfully grow sales of FemBloc permanent birth control in the European Union;
• estimates regarding the total addressable market for our products and U.S. product candidate;
• competitive companies and technologies in our industry;
• our business model and strategic plans for our products, product candidate, technologies and business, including our implementation thereof;
• commercial success and market acceptance of our products and U.S. product candidate;
• our ability to achieve and maintain adequate levels of coverage or reimbursement for FemBloc or any future product candidates, and our products we seek to commercialize;
• our ability to accurately forecast customer demand for our products and U.S. product candidate, and manage our inventory;
• our ability to build, manage, and maintain our direct sales and marketing organization, and to market and sell our FemaSeed intratubal insemination product, FemBloc permanent birth control system, and women-specific medical product solutions in markets in and outside of the United States;
• our ability to establish, maintain, grow or increase sales and revenues;
• our expectations about market trends;
• our ability to continue operating as a going concern;
• the ability of our clinical trials to demonstrate safety and effectiveness of our U.S. product candidate, FemBloc, and other positive results;
• our ability to enroll subjects in the clinical trial for our U.S. product candidate, FemBloc, in order to advance the development thereof on a timely basis;
• our ability to manufacture our products and U.S. product candidate, if approved, 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;
• 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 products and U.S. product candidate and our ability to avoid claims of infringement; and
• the volatility of the trading price of our common stock.
The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed with the Securities and Exchange Commission as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. The forward-looking statements contained in this Quarterly Report on Form 10-Q are excluded from the safe harbor protection provided by the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended.
PART I. FINANCIAL INFORMATION
FEMASYS INC.
(unaudited)
| Assets |
September 30,
2025 |
December 31,
2024 |
||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$ |
|
|
|||||
|
Accounts receivable, net
|
|
|
||||||
|
Inventory
|
|
|
||||||
|
Prepaid and other current assets
|
|
|
||||||
|
Total current assets
|
|
|
||||||
|
Property and equipment, at cost:
|
||||||||
| Leasehold improvements |
|
|
||||||
|
Office equipment
|
|
|
||||||
|
Furniture and fixtures
|
|
|
||||||
|
Machinery and equipment
|
|
|
||||||
|
Construction in progress
|
|
|
||||||
|
|
|
|||||||
|
Less accumulated depreciation
|
(
|
) |
(
|
) | ||||
|
Net property and equipment
|
|
|
||||||
|
Long-term assets:
|
||||||||
|
Lease right-of-use assets, net
|
|
|
||||||
|
Intangible assets, net of accumulated amortization
|
|
|
||||||
|
Other long-term assets
|
|
|
||||||
|
Total long-term assets
|
|
|
||||||
| Total assets | $ |
|
|
(continued)
FEMASYS INC.
(unaudited)
|
Liabilities and Stockholders’ Equity
|
September 30,
2025 |
December 31,
2024 |
||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$ |
|
|
|||||
|
Accrued expenses
|
|
|
||||||
|
Note payable
|
|
|
||||||
|
Convertible notes payable, net (including related parties)
|
|
|
||||||
|
Clinical holdback – current portion
|
|
|
||||||
|
Operating lease liabilities – current portion
|
|
|
||||||
|
Total current liabilities
|
|
|
||||||
|
Long-term liabilities:
|
||||||||
|
Clinical holdback – long-term portion
|
|
|
||||||
|
Lease liabilities – long-term portion
|
|
|
||||||
|
Total long-term liabilities
|
|
|
||||||
|
Total liabilities
|
|
|
||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders’ equity:
|
||||||||
|
Common stock, $
|
|
|
||||||
|
Treasury stock,
|
(
|
) |
(
|
) | ||||
|
Warrants
|
|
|
||||||
|
Additional paid-in-capital
|
|
|
||||||
|
Accumulated deficit
|
(
|
) |
(
|
) | ||||
|
Total stockholders’ equity
|
|
|
||||||
|
Total liabilities and stockholders' equity
|
$ |
|
|
The accompanying notes are an integral part of these condensed unaudited financial statements.
FEMASYS INC.
(unaudited)
| Three Months Ended September 30, |
|
Nine Months Ended September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
|
Sales
|
$ |
|
|
|
|
|||||||||||
|
Cost of sales (excluding depreciation expense)
|
|
|
|
|
||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
|
|
|
|
||||||||||||
|
Sales and marketing
|
|
|
|
|
||||||||||||
|
General and administrative
|
|
|
|
|
||||||||||||
|
Depreciation and amortization
|
|
|
|
|
||||||||||||
|
Total operating expenses
|
|
|
|
|
||||||||||||
|
Loss from operations
|
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Other (expense) income:
|
||||||||||||||||
|
Interest income
|
|
|
|
|
||||||||||||
|
Interest expense
|
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Other expense
|
(
|
) |
|
(
|
) |
|
||||||||||
|
Total other expense, net
|
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Loss before income taxes
|
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Income tax expense (benefit)
|
|
|
(
|
) |
(
|
) | ||||||||||
|
Net loss
|
$ |
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||
|
Net loss attributable to common stockholders, basic and diluted
|
$ |
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||
|
Net loss per share attributable to common stockholders, basic and diluted
|
$ |
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||
|
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
|
|
|
|
||||||||||||
The accompanying notes are an integral part of these condensed unaudited financial statements.
FEMASYS INC.
(unaudited)
|
|
Common stock |
|
Treasury common stock |
Additional
paid-in capital |
Accumulated
deficit
|
Total stockholders'
equity
|
||||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Warrants
|
||||||||||||||||||||||||||||
| THREE MONTHS ENDED SEPTEMBER 30, 2025 | ||||||||||||||||||||||||||||||||
|
Balance at June 30, 2025
|
|
$ |
|
|
$ |
(
|
) | $ |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||||||||||
| Issuance of common stock and warrants in connection with August 2025 financing, net of issuance costs |
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Exercise of pre-funded warrants
|
|
|
— |
|
(
|
) |
|
|
|
|||||||||||||||||||||||
|
Share-based compensation expense
|
— |
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Net loss
|
— |
|
— |
|
|
|
(
|
) |
(
|
) | ||||||||||||||||||||||
| Balance at September 30, 2025 |
|
$ |
|
|
$ |
(
|
) | $ |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||||||||||
| NINE MONTHS ENDED SEPTEMBER 30, 2025 | ||||||||||||||||||||||||||||||||
|
Balance at December 31, 2024
|
|
$ |
|
|
$ |
(
|
) | $ |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||||||||||
|
Issuance of common stock in connection with at-the-market
offering, net of issuance costs
|
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Issuance of common stock in connection with June 2025
financing, net of issuance costs
|
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
| Issuance of warrants in connection with June 2025 financing | — |
|
— |
|
|
(
|
) |
|
|
|||||||||||||||||||||||
|
Issuance of common stock and warrants in connection with August 2025
financing, net of issuance costs
|
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Exercise of pre-funded warrants
|
|
|
— |
|
(
|
) |
|
|
|
|||||||||||||||||||||||
|
Issuance of common stock in connection with ESPP
|
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Share-based compensation expense
|
— |
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Expiration of warrant
|
— |
|
— |
|
(
|
) |
|
|
|
|||||||||||||||||||||||
|
Conversion of convertible notes into common stock
|
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Net loss
|
— |
|
— |
|
|
|
(
|
) |
(
|
) | ||||||||||||||||||||||
|
Balance at September 30, 2025
|
|
$ |
|
|
$ |
(
|
) | $ |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||||||||||
The accompanying notes are an integral part of these condensed unaudited financial statements.
FEMASYS INC.
Condensed Statements of Stockholders’ Equity
(unaudited)
|
|
Common stock |
|
Treasury common stock
|
Additional
paid-in capital |
Accumulated deficit | Total stockholders’ equity | ||||||||||||||||||||||||||
|
|
Shares | Amount |
|
Shares | Amount | Warrants | ||||||||||||||||||||||||||
|
|
|
|
|
|
||||||||||||||||||||||||||||
|
THREE MONTHS ENDED SEPTEMBER 30, 2024
|
||||||||||||||||||||||||||||||||
|
Balance at June 30, 2024
|
|
$ |
|
|
$ |
(
|
) |
|
$ |
|
$ |
(
|
) | $ |
|
|||||||||||||||||
|
Share-based compensation expense
|
— |
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Net loss
|
— |
|
— |
|
|
|
(
|
) |
(
|
) | ||||||||||||||||||||||
|
Balance at September 30, 2024
|
|
$ |
|
|
$ |
(
|
) |
|
$ |
|
$ |
(
|
) | $ |
|
|||||||||||||||||
|
NINE MONTHS ENDED SEPTEMBER 30, 2024
|
||||||||||||||||||||||||||||||||
|
Balance at December 31, 2023
|
|
$ |
|
|
$ |
(
|
) | $ |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||||||||||
|
Issuance of common stock in connection with at-the-market offering, net of issuance costs
|
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Issuance of common stock in connection with ESPP
|
|
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Expiration of warrant
|
— |
|
— |
|
(
|
) |
|
|
|
|||||||||||||||||||||||
|
Share-based compensation expense
|
— |
|
— |
|
|
|
|
|
||||||||||||||||||||||||
|
Net loss
|
— |
|
— |
|
|
|
(
|
) |
(
|
) | ||||||||||||||||||||||
|
Balance at September 30, 2024
|
|
$ |
|
|
$ |
(
|
) | $ |
|
$ |
|
$ |
(
|
) | $ |
|
||||||||||||||||
The accompanying notes are an integral part of these condensed unaudited financial statements.
FEMASYS INC.
(unaudited)
| Nine Months ended | ||||||||
| September 30 | ||||||||
| 2025 | 2024 | |||||||
|
Cash flows from operating activities:
|
||||||||
|
Net loss
|
$ |
(
|
) |
(
|
) | |||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
|
Depreciation
|
|
|
||||||
|
Amortization
|
|
|
||||||
|
Amortization of right-of-use assets
|
|
|
||||||
|
Share-based compensation expense
|
|
|
||||||
|
Loss on property and equipment dispositions
|
|
|
||||||
|
Amortization of debt issuance costs and discount
|
|
|
||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable
|
(
|
) |
(
|
) | ||||
|
Inventory
|
(
|
) |
(
|
) | ||||
|
Prepaid and other assets
|
|
(
|
) | |||||
|
Accounts payable
|
|
(
|
) | |||||
|
Accrued expenses
|
(
|
) |
(
|
) | ||||
|
Lease liabilities
|
(
|
) |
(
|
) | ||||
|
Other liabilities
|
(
|
) |
(
|
) | ||||
|
Net cash used in operating activities
|
(
|
) |
(
|
) | ||||
|
Cash flows from investing activities:
|
||||||||
|
Acquisition of patents
|
(
|
) |
(
|
) | ||||
|
Purchases of property and equipment
|
(
|
) |
(
|
) | ||||
|
Net cash used in investing activities
|
(
|
) |
(
|
) | ||||
|
Cash flows from financing activities:
|
||||||||
|
Proceeds from the issuance of common stock in June 2025 financing
|
|
|
||||||
|
Issuance costs for June 2025 financing
|
(
|
) |
|
|||||
|
Proceeds from at-the-market sales of common stock
|
|
|
||||||
|
Issuance costs for at-the-market sales of common stock
|
(
|
) |
(
|
) | ||||
|
Proceeds from common stock issued through ESPP
|
|
|
||||||
|
Proceeds from the issuance of common stock, accompanying warrants and pre-funded warrants in August 2025 financing
|
|
|
||||||
|
Issuance costs for August 2025 financing
|
(
|
) |
|
|||||
|
Proceeds from the exercise of pre-funded warrants
|
|
|
||||||
|
Repayment of note payable
|
(
|
) |
|
|||||
|
Net cash provided by financing activities
|
|
|
||||||
|
Net change in cash and cash equivalents
|
|
(
|
) | |||||
|
Cash and cash equivalents:
|
||||||||
|
Beginning of period
|
|
|
||||||
|
End of period
|
$ |
|
|
|||||
|
Supplemental cash flow information
|
||||||||
|
Cash paid for:
|
||||||||
|
Taxes
|
$ |
|
|
|||||
|
Interest
|
|
|
||||||
|
Non-cash investing and financing activities:
|
||||||||
|
Property and equipment costs included in accounts payable and accrued expense
|
|
|
||||||
|
Acquisition of patents included in accounts payable
|
|
|
||||||
|
Issuance of warrants for underwriter commission in June 2025 financing
|
|
|
||||||
|
Issuance of warrants for underwriter commission in August 2025 financing
|
|
|
||||||
|
Deferred offering costs reclassified to additional paid-in-capital
|
|
|
||||||
|
Conversion of convertible notes into common stock
|
|
|
||||||
|
Prepaid insurance financed with promissory notes
|
|
|
||||||
The accompanying notes are an integral part of these condensed unaudited financial statements.
FEMASYS INC.
(unaudited)
(1)
Organization, Nature of Business, and Liquidity
Organization and Nature of Business
Femasys Inc. (the “Company” or “Femasys”) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a leading biomedical innovator, addressing significant unmet needs in women's health worldwide, with a broad patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The Company is a U.S. manufacturer that has received global regulatory approvals for its product portfolio worldwide, and its products are currently being commercialized in the U.S. and key international markets. FemaSeed® Intratubal Insemination, a groundbreaking infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, United Kingdom (“UK”), Canada, Israel, Australia and New Zealand. In August and September 2025, the Company announced FemSperm™, which includes a setup, preparation and analysis kit designed to expand the Company’s infertility portfolio and, for the first time, enables gynecologists to perform in-office sperm preparation and analysis for use with FemaSeed. FemVue®, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared and approved in Europe, UK, Canada, Japan, Israel, Australia and New Zealand. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel and New Zealand. FemBloc® permanent birth control is a revolutionary first-in-class non-surgical solution that involves minimally-invasive placement of a patented delivery system for precise delivery of our proprietary synthetic tissue adhesive (blended polymer) into both fallopian tubes simultaneously. Over time, the blended polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes in a safe and natural approach. This is in stark contrast to centuries-old surgical sterilization with reported risks that include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death. Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. The FemBloc non-surgical approach has the potential to offer a safe and effective, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost than the surgical alternative. In March 2025, the Company announced Conformité Européenne (“CE”) mark certification under European Union (“EU”) Medical Device Regulation (“MDR”) as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control and in June 2025, the Company announced CE mark certification under EU MDR for the class III blended polymer component, achieving approval for the entire FemBloc system in the EU. In August and September 2025, the Company announced UK and New Zealand regulatory approvals, respectively, for FemBloc. In March and September 2025, the Company announced strategic distribution partnerships for FemBloc in Spain and France/Benelux region, respectively. The Company received FDA approval in November 2025 of its investigational device exemption (“IDE”) supplement to move forward to the final phase of the pivotal clinical trial (clinicaltrials.gov: NCT05977751) for U.S. approval. FemChec®, a companion diagnostic product for FemBloc’s ultrasound-based confirmation test, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel, Australia and New Zealand. FemCath® for selective fallopian tube evaluation is U.S. FDA-cleared and approved in Europe, Canada and Israel. The Company is a woman-founded and led company with an expansive, internally created intellectual property portfolio with over
200
issued patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop products with commercialization efforts underway. The Company’s suite of products and U.S. product candidate address what the Company believes are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm.
Basis of Presentation
The Company has prepared the accompanying condensed financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to these rules and regulations. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K filed with the SEC on March 27, 2025 (the Annual Report). There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in the Annual Report.
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows at the dates for the periods presented. The results of operations for such interim periods are not necessarily indicative of the results expected for the full year.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expense during the reporting periods. Estimates for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates.
Liquidity
As of September 30, 2025, the Company had cash and cash equivalents of $
4,569,038
. The Company plans to finance its operations and commercial and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue primarily anticipated from domestic sales of FemaSeed and FemVue and international sales of FemBloc, FemaSeed, and FemVue. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted.
For the nine months ended September 30, 2025, the Company generated a net loss of $
14,677,582
. The Company expects such losses to increase over the next few years as the Company commercializes FemaSeed, FemBloc (in the EU, France and the Benelux region) and its other products and advances FemBloc through clinical development if and until FDA approval is received and the product is available to be marketed in the U.S.
The financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of September 30, 2025 of $
141,875,839
and expects to incur additional losses and negative operating cash flows for at least the next twelve months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations and future financing transactions. Although management expects the Company will continue as a going concern, there is no assurance that management’s plans will be successful because the availability and amount of such funding are not certain. Accordingly, substantial doubt exists about the Company’s ability to continue as a going concern for at least one year from the issuance of these financial statements. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern.
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09,
Income Taxes (Topic 740): Improvements to Income Tax Disclosures
. The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company’s annual reporting periods beginning after December 15, 2024. Adoption is either with a prospective method or a fully retrospective method of transition. Early adoption is permitted. The Company adopted the ASU on January 1, 2025, and it did not have a material impact on the Company’s financial statements.
Recently Issued Accounting Pronouncements – Not Yet Adopted
No other new accounting pronouncements issued or effective have had, or are expected to have, a material impact on the Company’s financial statements.
(2)
Fair Value of Financial Instruments
The Company applies a fair value hierarchy that requires the use of observable market data, when available, and prioritizes the inputs to valuation techniques used to measure fair value in the following categories:
Level 1 – Valuation is based upon quoted prices for identical instruments traded in active markets.
Level 2 – Valuation is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑based valuation techniques for which all significant assumptions are observable in the market.
Level 3 – Valuation is generated from model‑based techniques that use significant assumptions not observable in the market. These unobservable assumptions reflect the Company’s own estimates of assumptions market participants would use in pricing the asset or liability.
Certain of the Company’s financial instruments, including cash, accounts receivable and other liabilities approximate their fair value because of the short‑term maturity of these financial instruments.
(3)
Cash and Cash Equivalents
As of September 30, 2025 and December 31, 2024, money market funds and short-term U.S. Treasury bills included in cash and cash equivalents on the balance sheets were $
4,065,574
and $
3,451,761
, respectively, which represent level 1 within the fair value hierarchy. The Company considers all highly liquid investments with an initial maturity of three months or less when purchased to be cash equivalents.
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
(4)
Inventories
Inventory, stated at cost, consisted of the following:
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
|
Materials
|
$ |
|
|
|||||
|
Work in progress
|
|
|
||||||
|
Finished goods
|
|
|
||||||
|
Inventory
|
$ |
|
|
(5)
Accrued Expenses
Accrued expenses included the following:
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
|
Incentive and other compensation costs
|
$ |
|
|
|||||
|
Clinical trial costs
|
|
|
||||||
|
Accrued interest
|
|
|
||||||
|
Director fees
|
|
|
||||||
|
Other
|
|
|
||||||
|
Accrued expenses
|
$ |
|
|
(6)
Revenue Recognition
Revenue is recognized upon shipment of our goods based upon contractually stated pricing at standard payment terms typically ranging from
30
to
60
days. All revenue is recognized at a point in time. As of September 30, 2025, there were
no
unsatisfied performance obligations.
The majority of products sold directly to U.S. customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to our international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in original unopened cartons and are subject to a
30
% restocking fee. Throughout the periods presented, the Company has not had a history of significant returns.
The following table summarizes our sales by geographic region:
|
|
|
|
||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
|
Primary geographical markets
|
2025 | 2024 | 2025 | 2024 | ||||||||||||||
| U.S. | $ |
|
|
|
|
|||||||||||||
|
International
|
|
|
|
|
||||||||||||||
| Total | $ |
|
|
|
|
|||||||||||||
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
(7)
Commitments and Contingencies
Legal Claims
Occasionally, the Company may be a party to legal claims or proceedings, the outcomes of which are subject to significant uncertainty. In accordance with Accounting Standards Codification (ASC) 450,
Contingencies
, the Company will assess the likelihood of an adverse judgment for any outstanding claim as well as ranges of probable losses. When it has been determined that a loss is probable and the amount can be reasonably estimated, the Company will record a liability. For both periods presented, there were no material legal contingencies requiring accrual or disclosure.
The Company, as permitted under Delaware law and in accordance with its bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The Company entered into employment agreements with its officers, which provide for indemnification protection in the executive’s capacity as an officer for actions taken within the scope of employment. The maximum amount of potential future indemnification is unlimited; however, the Company has obtained directors’ and officers’ insurance that limits its exposure. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of September 30, 2025 and December 31, 2024.
(8)
Notes Payable
AFCO Credit Corporation (AFCO)
In July 2025, the Company executed a promissory note with AFCO to finance certain insurance premiums totaling $
367,450
, requiring the Company to pay $
31,672
in a down payment and make monthly installment payments. The annual interest rate was
7.44
% and the
monthly
installment is $
31,672
, which represents principal and interest.
As of September 30, 2025, and December 31, 2024, there were principal balances of $
276,489
and $
0
on the AFCO note in the accompanying balance sheets, respectively. Interest expense in connection with the AFCO promissory note was $
4,057
for the three and nine months ended September 30, 2025, and $
0
for the three and nine months ended September 30, 2024.
(9)
Convertible Notes with Warrants (November 2023 Financing)
On November 21, 2023, the Company issued (i) senior unsecured convertible notes (“Notes”) in an aggregate principal amount of $
6,850,000
, convertible into shares of common stock at a conversion price of $
1.18
per share, (ii) Series A Warrants to purchase up to an aggregate of
5,805,083
shares of common stock at an exercise price of $
1.18
per share, and (iii) Series B Warrants, together with the Series A Warrants, and, together with the convertible notes, to purchase up to an aggregate of
5,805,083
shares of common stock at an exercise price of $
1.475
per share. The financing resulted in aggregate gross proceeds of $
6,850,000
, before $
525,144
of transaction costs.
The Notes accrue interest at a rate of
6.0
% per annum, payable annually, in cash or shares of common stock at the Company’s option, and mature on
November 21, 2025
, unless earlier converted or redeemed. In November 2024, the Company paid $
111,000
of accrued interest in cash and $
300,000
accrued interest in common stock, comprising
315,790
shares.
The Notes are convertible into shares of common stock at the election of the holder at any time at an initial conversion price of $
1.18
. The Company agreed not to issue or sell any equity securities of the Company at a price below the then-current conversion price for a period of
18
months after closing, subject to certain exceptions. Beginning six months after issuance, the Company may require holders to convert their Notes into conversion shares if the closing price of the common stock exceeds $
2.36
per share for
10
consecutive trading days and the daily dollar trading volume of the common stock exceeds $
1,000,000
per day during the same period and certain equity conditions described in the Notes are satisfied. The Notes provide for certain events of default, whereby each holder of Notes will be able to require the Company to redeem in cash any or all of the holders’ Notes at a premium of
115
%. The conversion feature did not meet the requirements for separate accounting and is not accounted for as a derivative instrument. In April 2025, $
85,000
of convertible notes were converted into
72,033
shares of common stock.
The Warrants
The Series A Warrants are exercisable immediately and expire
five years
from the date of issuance. The Company has the right to call the exercise of the Series A Warrants if the closing price of the common stock exceeds
200
% of the Series A Exercise Price for
10
consecutive trading days and the daily dollar trading volume of the common stock exceeds $
1,000,000
per day during the same period and certain equity conditions are satisfied.
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
The Series B Warrants expired in
.
The Series A Warrants are classified as components of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock from which they are issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise.
For the three months ended September 30, 2025, the Company recognized total interest expense of $
532,073
, including coupon interest expense of $
101,475
, amortization of debt discount and issuance costs of $
426,541
and AFCO note payable interest expense of $
4,057
. For the three months ended September 30, 2024, the Company recognized total interest expense of $
413,290
, including coupon interest expense of $
102,750
and amortization of debt discount and issuance costs of $
310,540
. For the nine months ended September 30, 2025, the Company recognized total interest expense of $
1,483,022
, including coupon interest expense of $
305,812
, amortization of debt discount and issuance costs of $
1,173,153
and AFCO note payable interest expense of $
4,057
. For the nine months ended September 30, 2024, the Company recognized total interest expense of $
1,163,153
, including coupon interest expense of $
308,250
and amortization of debt discount and issuance costs of $
854,903
.
The Notes, net of unamortized discount costs, were $
6,507,354
and $
5,406,228
as of September 30, 2025 and December 31, 2024, respectively. The fair value of the convertible notes on September 30, 2025 and December 31, 2024, calculated using a discounted cash flow analysis using level 3 inputs, was $
6,699,620
and $
6,493,720
, respectively.
(10)
Stockholders’ Equity
On July 1, 2022, the Company filed a shelf registration statement to sell up to $
150
million in common and preferred stock, debt securities and warrants. Additionally, the Company entered into an Equity Distribution Agreement with Piper Sandler & Co. (the “Sales Agent”) and filed a related prospectus establishing an “at-the-market” facility, pursuant to which the Company may offer and sell shares of common stock from time to time through the Sales Agent. In October 2023, the Sales Agent was authorized to sell shares for aggregate proceeds up to $
16.7
million at current market prices until all shares are sold.
For the nine months ended September 30, 2025, the Company sold approximately
3.8
million shares of common stock for aggregate proceeds of approximately $
5.5
million, and as of September 30, 2025, approximately $
1.5
million remained available for sale pursuant to the prospectus. As of September 30, 2025, the amount the Company was authorized to sell was subject to baby-shelf limitations.
June 2025 Financing
In June 2025, the Company sold
3,600,000
shares of common stock in an underwritten public offering at $
0.85
per share. The Company also sold
1,686,275
shares of common stock in a separate concurrent private placement at a price of $
0.85
per share to certain existing institutional stockholders and a price of $
1.02
per share to certain directors and officers. The offering resulted in aggregate gross proceeds of $
4,510,001
, before $
804,940
of transaction costs.
Additionally, common warrants to purchase
105,726
shares of common stock were issued to the underwriter as a commission for services performed. The underwriter warrants are exercisable beginning December 2, 2025, have a
5
-year term and an exercise price of $
1.0625
per share. The warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock from which they are issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. The warrants were valued at $
56,035
using Black-Scholes assumptions. As of September 30, 2025,
105,726
underwriter warrants remain outstanding.
Any Market Purchase Agreement
On June 30, 2025, the Company entered into an Any Market Purchase Agreement (“Purchase Agreement”) with Alumni Capital LP (“Alumni”) whereby the Company has the right, but not obligation, to sell to Alumni up to an aggregate of $
10
million in shares of common stock in a series of purchases until December 31, 2026. The Company may elect that Alumni purchase up to $
1
million in shares of common stock (or up to $
5
million if mutually agreed) at either (i) the lowest traded price for
four
previous business
days
, multiplied by
90
% or (ii) up to the lesser of (a) $
1
million in shares of common stock or (b)
100
% of the average daily trading volume of common stock for previous
two
business
days
at lowest daily dollar volume-weighted average price, multiplied by
97
%. The Company is limited to issuances to Alumni or
19.99
% of the shares of common stock outstanding immediately prior to the execution of the Purchase Agreement. The Purchase Agreement will allow the Company to raise equity on a periodic basis at its discretion depending on a variety of factors including market conditions, the trading price of the common stock, and use of proceeds for operating activities. Due to certain pricing and settlement provisions, the Purchase Agreement includes an embedded put option contract. The Company will account for the Purchase Agreement as a derivative, with a fair value deemed de minimis. The difference between the discounted purchase price and fair value of the shares will be expensed in the period the transaction occurs as a non-cash, nonoperating financing cost.
The Company incurred a
2
% commitment fee of $
200,000
and an additional $
86,295
in expenses as of September 30, 2025, which are included as other expense in the unaudited interim Condensed Statements of Comprehensive Loss.
August 2025 Financing
On August 25, 2025, the Company entered into a securities purchase agreement pursuant to which the Company sold (i)
10,434,586
shares of common stock in a public offering and to certain Company officers, (ii) pre-funded warrants to purchase
11,750,000
shares of common stock, and (iii) common warrants to purchase
22,184,586
shares of common stock. Additionally, common warrants to purchase
443,692
shares of common stock were issued to the underwriter as compensation for services performed.
The pre-funded warrants, common warrants and
underwriter warrants were exercisable immediately following the closing
date of the offering. The pre-funded warrants have an unlimited term and an
exercise price of $
0.0001
per share. The common warrants have a
5
-year term and
an exercise price of $
0.36
per share, except for common warrants sold to
certain Company officers, which have an exercise price of $
0.5151
per share. The
underwriter warrants have a
5
-year term and exercise price of $
0.45
per
share. The offering resulted in aggregate gross proceeds of $
7,998,826
, before
$
930,132
of transaction costs.
The pre-funded warrants and common warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise.
The common stock was valued at $
3,770,001
, based on the Company’s stock price. The pre-funded warrants and common warrants were valued at $
4,230,000
and $
5,324,301
, respectively, using the following Black-Scholes assumptions:
|
Pre-funded
warrants |
Common
warrants |
Underwriter
warrants |
||||||||||
|
Expected term (in years)
|
|
|
|
|||||||||
|
Risk‑free interest rate
|
|
% |
|
% |
|
% | ||||||
|
Dividend yield
|
|
% |
|
% |
|
% | ||||||
|
Expected volatility
|
|
% |
|
% |
|
% | ||||||
|
Exercise price
|
$ |
|
$
|
$ |
|
|||||||
|
Stock price
|
$ |
|
$
|
$ |
|
|||||||
|
Black-Scholes value
|
$ |
|
$
|
$ |
|
The net proceeds of $
7,068,694
were allocated to the common stock, pre-funded warrants and common warrants using the relative fair value method and were recorded to stockholders’ equity.
As of September 30, 2025,
7,457,620
pre-funded warrants,
22,184,586
common warrants and
443,692
placement agent warrants remain outstanding.
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
(11)
Equity Incentive Plans and Warrants
Stock-Based Awards
(a)
Stock Option Plans
Activity under the Company’s stock option plans for the nine months ended September 30, 2025 was as follows:
|
Number
of options |
Weighted
average exercise price |
Aggregate
Intrinsic Value |
||||||||||
|
Outstanding at December 31, 2024
|
|
$ |
|
|||||||||
|
Granted
|
|
|
||||||||||
|
Forfeited
|
(
|
) |
|
|||||||||
|
Outstanding at September 30, 2025
|
|
$ |
|
$ |
|
|||||||
|
Vested and exercisable at September 30, 2025
|
|
$ |
|
$ |
|
The intrinsic value represents the amount by which the market price of the underlying stock at September 30, 2025 exceeds the exercise price of an option.
Options granted under the 2021 Stock Option Plan for the nine months ended September 30, 2025 to employees and nonemployees were
1,529,515
and
70,400
, respectively and the weighted average exercise prices were $
1.09
and $
0.98
, respectively. The weighted average fair values of the options granted to employees and nonemployees were $
0.84
and $
0.73
, respectively and were estimated using the following Black-Scholes assumptions:
| Employees | Nonemployees | |||||||
|
Expected term (in years)
|
|
|
||||||
|
Risk‑free interest rate
|
|
% |
|
% | ||||
|
Dividend yield
|
|
% |
|
% | ||||
|
Expected volatility
|
|
% |
|
% |
On June 25, 2025, Femasys stockholders approved an amendment to the 2021 Equity Incentive Plan to increase the total number of shares of common stock authorized for issuance by
3,000,000
. As of September 30, 2025, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was
3,200,591
.
(b)
Inducement Grants
Since 2023, the Company has granted
250,000
inducement grants, a stock option grant to certain employees for the right to purchase shares, which were approved by the Compensation Committee. The inducement grants vest in equal installments over
four years
provided the employee remains employed by the Company on the vesting date. In the first quarter of 2025, there were
100,000
options forfeited. In the second quarter of 2025, there was a grant of
100,000
options.
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
The inducement grants are summarized as follows:
|
Number
of options |
Weighted
average exercise price |
Weighted
average remaining life years |
||||||||||
|
Outstanding at December 31, 2024
|
|
$ |
|
|
||||||||
|
Granted
|
|
|
|
|||||||||
|
Forfeited
|
(
|
) |
|
— | ||||||||
|
Outstanding at September 30, 2025
|
|
$ |
|
|
||||||||
|
Vested and exercisable at September 30, 2025
|
|
$ |
|
|
(c)
Share-Based Compensation Expense
The following table shows the share-based compensation expense related to vested stock option grants to employees and nonemployees by financial statement line item on the accompanying condensed statements of comprehensive loss:
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
|
Research and development
|
$ |
|
|
|
|
|||||||||||
|
Sales and marketing
|
|
|
|
|
||||||||||||
|
General and administrative
|
|
|
|
|
||||||||||||
|
Total share-based compensation expense
|
$ |
|
|
|
|
|||||||||||
As of September 30, 2025, the remaining share-based compensation expense that is expected to be recognized in future periods for employees and nonemployees is $
1,692,530
, which includes $
155,222
of compensation expense to be recognized upon achieving certain performance conditions. For service-based awards, the $
1,537,308
of unrecognized expense is expected to be recognized over a weighted average period of
2.7
years.
(d)
Employee Stock Purchase Plan (ESPP)
For the nine months ended September 30, 2025,
49,247
shares of common stock were issued under the Company’s ESPP at a fair value of $
40,875
. For the nine months ended September 30, 2024,
12,081
shares of common stock were issued under the Company’s ESPP at a fair value of $
10,390
. As of September 30, 2025, the total number of shares of common stock reserved for future awards under the ESPP was
719,668
.
(12)
Related‑Party Transactions
In November 2023, the Company issued unsecured convertible notes and accompanying Series A and Series B Warrants (see Note 9). The transaction included the issuance of a $
5
million convertible note and Series A and Series B Warrants to PharmaCyte Biotech, Inc (“PharmaCyte”). The interim CEO, President and Director of PharmaCyte Biotech, Inc., Joshua Silverman, serves on the Company’s board of directors. The Series B Warrants expired in
. In November 2024, the Company paid PharmaCyte accrued interest on the convertible note of $
300,000
in equity comprising
315,790
common shares.
In conjunction with the June 2025 Financing, certain officers and directors purchased
98,040
common shares in the private placement offering at a price of $
1.02
per share.
In conjunction with the August 2025 Financing, certain officers purchased
87,363
common shares at a price of $
0.5151
per share.
In addition, for the nine months ended September 30, 2025 and year ended December 31, 2024, a family member of the CEO was employed by the Company.
FEMASYS INC.
Condensed Notes to Financial Statements
(unaudited)
(13)
Net Loss per Share Attributable to Common Stockholders
The following table sets forth the computation of the basic and diluted net loss per share:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
|
Net loss attributable to common stockholders, basic and diluted
|
$ |
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||
|
Weighted average number of shares used in computing net
loss per share attributable to common stockholders, basic and diluted
|
|
|
|
|
||||||||||||
|
Net loss per share attributable to common stockholders, basic and diluted
|
$ |
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||
The pre-funded warrants from
the August 2025 Financing are included in the weighted average shares above.
The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
|
Options to purchase common stock
|
|
|
|
|
||||||||||||
|
Warrants to purchase common stock, in connection with April 2023 financing
|
|
|
|
|
||||||||||||
|
Warrants to purchase common stock, in connection with November 2023 financing
|
|
|
|
|
||||||||||||
|
Warrants to purchase common stock, in connection with June 2025 financing
|
|
|
|
|
||||||||||||
|
Warrants to purchase common stock, in connection with August 2025 financing
|
|
|
|
|
||||||||||||
|
Warrants to purchase common stock
|
|
|
|
|
||||||||||||
|
Total potential shares
|
|
|
|
|
||||||||||||
(14)
Income Taxes
The effective tax rate of
0
% for the nine months ended September 30, 2025 and 2024 was lower than the statutory rate due to the Company remaining in a full valuation allowance position.
(15)
Segment Reporting
In accordance with FASB ASC Topic 280,
Segment Reporting
, the Company has determined that it operates as a
business segment, which is the development and commercialization of therapeutic and diagnostic products that service women’s reproductive health needs (infertility and permanent birth control).
The determination of a
business segment is consistent with the financial information regularly provided to the Company’s chief operating decision maker (“CODM”). As a
reportable segment entity, the Company’s segment performance measure is net loss attributable to shareholders. The measurement of segment assets is reported on the balance sheet as total assets. The Company’s CODM is its Chief Executive Officer and Chief Financial Officer, who together review and evaluate net income for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.
Significant segment expenses, as provided to the CODM are as follows:
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
|
Sales
|
$ |
|
|
|
|
|||||||||||
|
Cost of sales (excluding depreciation expense)
|
|
|
|
|
||||||||||||
|
Research and development expense
|
|
|
|
|
||||||||||||
|
Other research and development expense
1
|
|
|
|
|
||||||||||||
|
Total research and development expense
|
|
|
|
|
||||||||||||
|
Sales and marketing expense
|
|
|
|
|
||||||||||||
|
General and administrative expense
|
|
|
|
|
||||||||||||
|
Depreciation and amortization expense
|
|
|
|
|
||||||||||||
|
Total operating expenses
|
|
|
|
|
||||||||||||
|
Total other expense, net
|
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Loss before income taxes
|
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
|
Income tax benefit
|
|
|
(
|
) |
(
|
) | ||||||||||
|
Net loss
|
$ |
(
|
) |
(
|
) |
(
|
) |
(
|
) | |||||||
1
Other research and development expense include clinical affairs, regulatory, manufacturing and quality assurance expenses.
(16)
Subsequent Events
In October 2025,
707,620
pre-funded warrants from the August 2025 Financing were exercised at a price of $
0.0001
per share. Additionally, in October and November 2025,
8,652,777
common warrants from the August 2025 Financing were exercised for at a price of $
0.36
per share. Total proceeds from the exercised warrants were $
3,115,000
.
On November 3, 2025, the Company entered into a definitive agreement for the issuance of (i) senior secured convertible notes (“November 2025 Notes” and “November 2025 Financing”) in an aggregate principal amount of $
12,000,000
, convertible into shares of
16,378,563
common stock at a conversion price of $
0.73
per share, (ii) Series A-1 Warrants to purchase up to an aggregate of
16,378,563
shares of common stock at an exercise price of $
0.81
per share, subject to adjustments, (iii) Series B-1 Warrants to purchase an aggregate of
16,378,563
shares of common stock at an exercise price of $
0.92
per share, subject to adjustments, and (iv) Series C-1 Warrants to purchase an aggregate of
16,378,563
shares of common stock at an exercise price of $
1.10
per share, subject to adjustments. The financing resulted in aggregate gross proceeds of $
12,000,000
.
The November 2025 Notes accrue interest at a rate of
8.5
% per annum, payable
annually
in-kind by increasing the principal balance outstanding, The Notes, Series A-1, B-1 and C-1 Warrants have a
10
-year maturity.
In
November 2025, the Company sold
1,817,054
shares under the at-the-market
facility, resulting in gross cash proceeds of $
1,516,371
.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or the SEC, on March 27, 2025. This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “goal,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements and reflect our beliefs and opinions on the relevant subject. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report on Form 10-Q. The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date hereof. These statements are based upon information available to us as of the filing date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.
Overview
We are a leading biomedical innovator, addressing significant unmet needs in women’s health worldwide, with a broad patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. We are a U.S. manufacturer that has received global regulatory approvals for its product portfolio worldwide, and its products are currently being commercialized in the U.S. and key international markets. FemaSeed® Intratubal Insemination, a groundbreaking infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, United Kingdom (“UK”), Canada, Israel, Australia and New Zealand. A peer-reviewed publication of positive data from its pivotal clinical trial of FemaSeed demonstrated effectiveness and safety with high satisfaction from both patients and practitioners. FemSperm™, which includes a setup, preparation and analysis kit designed to expand our infertility portfolio and, for the first time, enables gynecologists to perform in-office sperm preparation and analysis for use with FemaSeed. FemVue®, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared and approved in Europe, UK, Canada, Japan, Israel, Australia and New Zealand. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel and New Zealand. FemBloc® permanent birth control is a revolutionary first-in-class non-surgical solution, which involves minimally-invasive placement of a patented delivery system for precise delivery of our proprietary synthetic tissue adhesive (blended polymer) into both fallopian tubes simultaneously. Over time, the blended polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes in a safe and natural approach. This is in stark contrast to centuries-old surgical sterilization with reported risks that include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death. Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. The FemBloc non-surgical approach has the potential to offer a safe and effective, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost than the surgical alternative. A peer-reviewed publication of positive data from its initial clinical trials of FemBloc has demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners. In March 2025, we announced Conformité Européenne (“CE”) mark certification under European Union (“EU”) Medical Device Regulation (“MDR”) as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control and in June 2025, we announced CE mark certification under EU MDR for the class III blended polymer component, achieving approval for the entire FemBloc system in the EU. In August and September 2025, we announced UK and New Zealand regulatory approvals, respectively, for FemBloc. In March and September 2025, we announced strategic distribution partnerships for FemBloc in Spain and France/Benelux region, respectively. The Company received FDA approval in November 2025 of its investigational device exemption (“IDE”) supplement to move forward to the final phase of the pivotal clinical trial (clinicaltrials.gov: NCT05977751) for U.S. approval. FemChec®, a companion diagnostic product for FemBloc’s ultrasound-based confirmation test, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel, Australia and New Zealand. FemCath® for selective fallopian tube evaluation is U.S. FDA-cleared and approved in Europe, Canada and Israel for selective fallopian tube evaluation. We are a woman-founded and led company with an expansive, internally created intellectual property portfolio with over 200 issued patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop products with commercialization efforts underway. Our suite of products and U.S. product candidate address what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm.
Corporate Update
On November 10, 2025, we announced a second partner order for FemBloc in Europe.
On November 3, 2025, we announced FDA IDE approval to continue enrollment in the final phase of the FINALE pivotal trial for FemBloc.
On November 3, 2025, we announced a definitive agreement for the issuance of $12 million in secured convertible notes and accompanying warrants for total potential funding of $58 million, if all warrants are exercised for cash.
On October 22, 2025, we announced the initiation of post-market surveillance study for FemBloc in Europe.
On September 25, 2025, we announced a partnership with Kebomed, a leading European distributor of medical devices and equipment, to commercialize FemBloc in France, the Netherlands, Belgium and Luxembourg.
On September 22, 2025, we announced a partnership with Medical Electronic Systems LLC (MES) to provide FemSperm
Analysis Kit for use with FemaSeed.
On September 11, 2025, we announced the FemSperm
Insemination Prep Kit, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination.
On September 8, 2025, we announced New Zealand regulatory approval of FemBloc.
On August 25, 2025, we announced an underwritten public offering with gross proceeds of $8.0 million.
On August 21, 2025, we announced the FemSperm set-up kit to activate gynecologists for FemaSeed Intratubal Insemination.
On August 20, 2025, we announced UK regulatory approval of FemBloc.
Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024
The following table shows our results of operations for the three months ended September 30, 2025 and 2024:
| Three Months Ended September 30, | ||||||||||||||||
| 2025 | 2024 | Change | % Change | |||||||||||||
|
Sales
|
$ | 729,394 | 554,908 | 174,486 | 31.4 | % | ||||||||||
|
Cost of sales (excluding depreciation expense)
|
293,838 | 190,839 | 102,999 | 54.0 | % | |||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
1,382,022 | 2,303,241 | (921,219 | ) | (40.0 | )% | ||||||||||
|
Sales and marketing
|
1,143,805 | 1,572,189 | (428,384 | ) | (27.2 | )% | ||||||||||
|
General and administrative
|
1,477,800 | 1,530,791 | (52,991 | ) | (3.5 | )% | ||||||||||
|
Depreciation and amortization
|
85,697 | 76,288 | 9,409 | 12.3 | % | |||||||||||
|
Total operating expenses
|
4,089,324 | 5,482,509 | (1,393,185 | ) | (25.4 | )% | ||||||||||
|
Loss from operations
|
(3,653,768 | ) | (5,118,440 | ) | 1,464,672 | (28.6 | )% | |||||||||
|
Other (expense) income:
|
||||||||||||||||
|
Interest income
|
17,315 | 124,028 | (106,713 | ) | (86.0 | )% | ||||||||||
|
Interest expense
|
(532,073 | ) | (413,290 | ) | (118,783 | ) | 28.7 | % | ||||||||
|
Other expense
|
(26,295 | ) | — | (26,295 | ) | 100.0 | % | |||||||||
|
Total other expense, net
|
(541,053 | ) | (289,262 | ) | (251,791 | ) | 87.0 | % | ||||||||
|
Loss before income taxes
|
(4,194,821 | ) | (5,407,702 | ) | 1,212,881 | (22.4 | )% | |||||||||
|
Income tax expense
|
— | 1,158 | (1,158 | ) | 100.0 | % | ||||||||||
|
Net loss
|
$ | (4,194,821 | ) | (5,408,860 | ) | 1,214,039 | (22.4 | )% | ||||||||
Sales
Sales increased by $174,486, or 31.4%, to $729,394 for the three months ended September 30, 2025, from $554,908 for the three months ended September 30, 2024, primarily attributable to sales of FemBloc.
Cost of sales
Cost of sales increased by $102,999 or 54.0%, to $293,838 for the three months ended September 30, 2025, from $190,839 for the three months ended September 30, 2024, and is attributed to increased sales.
Research and development
The following table summarizes our R&D expenses incurred during the periods presented:
| Three Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
|
Compensation and related personnel costs
|
$ | 1,037,538 | 1,256,061 | |||||
|
Clinical-related costs
|
242,549 | 437,163 | ||||||
|
Material and development costs
|
7,448 | 312,644 | ||||||
|
Professional and outside consultant costs
|
76,793 | 291,955 | ||||||
| Regulatory and other costs | 17,694 | 5,418 | ||||||
|
Total research and development expenses
|
$ | 1,382,022 | 2,303,241 | |||||
R&D expenses decreased by $921,219 or 40.0%, to $1,382,022 for the three months ended September 30, 2025 from $2,303,241 for the three months ended September 30, 2024. The decrease resulted primarily from the commercialization of development products into inventory and reduced compensation costs, clinical costs and professional fees.
Sales and marketing
Sales and marketing expenses decreased by $428,384 or 27.2%, to $1,143,805 for the three months ended September 30, 2025 from $1,572,189 for the three months ended September 30, 2024. The decrease resulted primarily from reduced professional fees and compensation costs.
General and administrative
General and administrative expenses decreased by $52,991, or 3.5%, to $1,477,800 for the three months ended September 30, 2025 from $1,530,791 for the three months ended September 30, 2024. The decrease resulted primarily from reduced professional fees.
Depreciation and amortization
Depreciation and amortization expenses increased by $9,409, or 12.3%, to $85,697 for the three months ended September 30, 2025 from $76,288 for the three months ended September 30, 2024. The increase resulted from additional fixed assets and intangible assets in service.
Other expense, net
Other expense, net increased by $251,791, or 87.0%, to $541,053 for the three months ended September 30, 2025 from $289,262 for the three months ended September 30, 2024. The increase resulted from increased non-cash discount amortization related to the convertible notes payable, expenses related to the Any Market Purchase Agreement and reduced interest income.
Income tax expense
Income tax expense decreased by $1,158 or 100%, to $0 for the three months ended September 30, 2025 from $1,158 for the three months ended September 30, 2024 due to a decrease in the state minimum taxes we were required to pay.
Results of Operations
Comparison of the Nine Months Ended
September
30, 2025 and 2024
The following table shows our results of operations for the nine months ended September 30, 2025 and 2024:
| Nine Months Ended September 30, | ||||||||||||||||
| 2025 | 2024 | Change | % Change | |||||||||||||
|
Sales
|
$ | 1,479,926 | 1,047,532 | 432,394 | 41.3 | % | ||||||||||
|
Cost of sales (excluding depreciation expense)
|
569,275 | 352,496 | 216,779 | 61.5 | % | |||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
5,764,923 | 6,049,847 | (284,924 | ) | (4.7 | )% | ||||||||||
|
Sales and marketing
|
3,037,349 | 2,847,866 | 189,483 | 6.7 | % | |||||||||||
|
General and administrative
|
4,817,485 | 4,645,412 | 172,073 | 3.7 | % | |||||||||||
|
Depreciation and amortization
|
256,835 | 215,144 | 41,691 | 19.4 | % | |||||||||||
|
Total operating expenses
|
13,876,592 | 13,758,269 | 118,323 | 0.9 | % | |||||||||||
|
Loss from operations
|
(12,965,941 | ) | (13,063,233 | ) | 97,292 | (0.7 | )% | |||||||||
|
Other (expense) income:
|
||||||||||||||||
|
Interest income
|
53,488 | 532,850 | (479,362 | ) | (90.0 | )% | ||||||||||
|
Interest expense
|
(1,483,022 | ) | (1,163,153 | ) | (319,869 | ) | 27.5 | % | ||||||||
|
Other expense
|
(286,295 | ) | — | (286,295 | ) | 100.0 | % | |||||||||
|
Total other expense, net
|
(1,715,829 | ) | (630,303 | ) | (1,085,526 | ) | 172.2 | % | ||||||||
|
Loss before income taxes
|
(14,681,770 | ) | (13,693,536 | ) | (988,234 | ) | 7.2 | % | ||||||||
|
Income tax benefit
|
(4,188 | ) | (592 | ) | (3,596 | ) | 607.4 | % | ||||||||
|
Net loss
|
$ | (14,677,582 | ) | (13,692,944 | ) | (984,638 | ) | 7.2 | % | |||||||
Sales
Sales increased by $432,394, or 41.3%, to $1,479,926 for the nine months ended September 30, 2025 from $1,047,532 for the nine months ended September 30, 2024, primarily attributable to sales of FemBloc and FemVue.
Cost of sales
Cost of sales increased by $216,779 or 61.5%, to $569,275 for the nine months ended September 30, 2025 from $352,496 for the nine months ended September 30, 2024. The increase is primarily attributed to increased sales.
Research and development
The following table summarizes our R&D expenses incurred during the periods presented:
| Nine Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
|
Compensation and related personnel costs
|
$ | 3,592,293 | 3,219,997 | |||||
|
Clinical-related costs
|
898,914 | 1,311,526 | ||||||
|
Material and development costs
|
332,813 | 845,473 | ||||||
|
Professional and outside consultant costs
|
380,736 | 578,614 | ||||||
|
Regulatory and other costs
|
560,167 | 94,237 | ||||||
|
Total research and development expenses
|
$ | 5,764,923 | 6,049,847 | |||||
R&D expenses decreased by $284,924 or 4.7%, to $5,764,923 for the nine months ended September 30, 2025 from $6,049,847 for the nine months ended September 30, 2024. The decrease relates primarily to the commercialization of development products into inventory, reduced clinical costs and professional fees, partially offset by increased regulatory costs.
Sales and marketing
Sales and marketing expenses increased by $189,483 or 6.7%, to $3,037,349 for the nine months ended September 30, 2025 from $2,847,866 for the nine months ended September 30, 2024. The increase relates primarily to compensation and travel costs as we began recruitment of a commercial team in 2024 to promote our available products, partially offset by reduced professional fees.
General and administrative
General and administrative expenses increased by $172,073, or 3.7%, to $4,817,485 for the nine months ended September 30, 2025 from $4,645,412 for the nine months ended September 30, 2024. The increase relates primarily to increased compensation costs and professional fees.
Depreciation and amortization
Depreciation and amortization expenses increased by $41,691, or 19.4%, to $256,835 for the nine months ended September 30, 2025 from $215,144 for the nine months ended September 30, 2024. The increase resulted from additional fixed assets and intangible assets in service.
Other expense, net
Other expense, net increased by $1,085,526, or 172.2%, to $1,715,829 for the nine months ended September 30, 2025 from $630,303 for the nine months ended September 30, 2024. The increase resulted from increased non-cash discount amortization related to the convertible notes payable, expenses related to the Any Market Purchase Agreement and reduced interest income.
Income tax benefit
Income tax benefit increased by $3,596 or 607.4%, to $4,188 for the nine months ended September 30, 2025 from $592 for the nine months ended September 30, 2024 due to a decrease in the state minimum taxes we were required to pay.
Liquidity and Capital Resources
Sources of liquidity
Since our inception through September 30, 2025, our operations have been financed primarily by net proceeds from the sale of our common stock and convertible preferred stock, indebtedness and, to a lesser extent, product revenue. As of September 30, 2025, we had $4,569,038 of cash and cash equivalents and an accumulated deficit of $141,875,839.
In
July 2022, we entered into an Equity Distribution Agreement with Piper Sandler
& Co. (the “Sales Agent”) and filed a related prospectus establishing an
“at-the-market” facility, pursuant to which we may offer and sell shares of our
common stock from time to time through the Sales Agent. As of October 2023, the
Sales Agent was authorized to sell shares of common stock for an aggregate
price up to $16.7 million pursuant to the prospectus. As of September 30, 2025,
approximately 8.4 million shares of common stock had been sold for aggregate
proceeds of approximately $15.2 million. As of September 30, 2025, the amount
we were authorized to sell was subject to baby-shelf limitations. As of
September 30, 2025, the available amount pursuant to the prospectus was
approximately $1.5 million.
Subsequent
to September 30,
2025, we sold 1,817,054 shares for aggregate proceeds
of approximately $1.5 million.
In June 2025, we sold 3,600,000 shares of common stock in an underwritten public offering at $0.85 per share. Separately and concurrently, we sold 1,686,275 shares of common stock in a private placement at a price of $0.85 per share to certain existing institutional stockholders and a price of $1.02 per share to certain directors and officers. Net proceeds from the transaction were $3,705,061.
On June 30, 2025, we entered into an Any Market Purchase Agreement (“Purchase Agreement”) with Alumni Capital LP (“Alumni”) whereby we have the right, but not obligation, to sell to Alumni up to an aggregate of $10 million in shares of common stock in a series of purchases until December 31, 2026. We may elect that Alumni purchase up to $1 million in shares of common stock (or up to $5 million if mutually agreed) at either (i) the lowest traded price for 4 previous business days, multiplied by 90%, or (ii) up to the lesser of (a) $1 million in shares of common stock, or (b) 100% of the average daily trading volume of common stock for previous two business days at lowest daily dollar volume-weighted average price, multiplied by 97%. We are limited to issuances to Alumni or 19.99% of the shares of common stock outstanding immediately prior to the execution of the Purchase Agreement.
In August 2025, we sold an aggregate of (i)
10,434,586 shares of common stock in a public offering and to certain Company
officers (ii) pre-funded warrants to purchase up to 11,750,000 shares of common
stock and (iii) common warrants to purchase up to 22,184,586 shares of common
stock. Additionally, common warrants to purchase 443,692 shares of common stock
were issued to the underwriter as compensation for services performed. The
purchase price per share for the common stock was $0.36, except for shares sold
to certain company officers, which was $0.5151 per share. The purchase price
per share for the pre-funded warrants was $0.3599. The net proceeds from the
August 2025 Financing at closing were approximately $7.1 million.
Subsequent to
September 30,
2025, 707,620 pre-funded warrants and 8,652,777 common
warrants were exercised for approximately $3.1 million.
In November 2025, we entered into a definitive agreement for the issuance of (i) senior secured convertible notes in an aggregate principal amount of $12,000,000, convertible into shares of 16,378,563 common stock at a conversion price of $0.73 per share, (ii) Series A-1 Warrants to purchase up to an aggregate of 16,378,563 shares of common stock at an exercise price of $0.81 per share, subject to adjustments (iii) Series B-1 Warrants to purchase an aggregate of 16,378,563 shares of common stock at an exercise price of $0.92 per share, subject to adjustments, and (iv) Series C-1 Warrants to purchase an aggregate of 16,378,563 shares of common stock at an exercise price of $1.10 per share, subject to adjustments . The financing resulted in aggregate gross proceeds of $12,000,000, with total potential funding of $58 million, if all warrants are exercised for cash.
Funding requirements
Based on our current
operating plan, our current cash and cash equivalents, anticipated revenues
from product sales and proceeds and application of our November 2025 Financing
are expected to be sufficient to fund our ongoing operations into September 2026.
However, it is not sufficient to fund our ongoing operations for twelve months
from the date of these financial statements and we will need to obtain
additional financing to fund our ongoing operations. Our convertible notes
contain restrictions that limit our ability to issue securities without
complying with certain participation rights. Our estimate as to how long we
expect our existing cash and cash equivalents to be able to continue to fund
our operations is based on assumptions that may prove to be wrong, and we could
use our available capital resources sooner than we currently expect. Changing
circumstances, some of which may be beyond our control, could cause us to
consume capital significantly faster than we currently anticipate. As a result
of our current limited financial liquidity, we have concluded that substantial
doubt exists about our ability to continue as a going concern.
Our cash and cash equivalents as of September 30, 2025 will not be sufficient to sustain our operations, including funding our U.S. product candidate, FemBloc through regulatory approval, and we anticipate needing to raise additional capital to complete the U.S. development and EU commercialization of our product candidate. The majority of the proceeds from the November
2025 Financing will
be
used to repay
the November 2023 Convertible Notes.
We still need significant additional
financing to fund our product development and operations. However, we can give no assurances that we will be able to secure additional sources of funds to support our commercialization efforts or operations, or if such funds will be available to us, that such additional financing will be sufficient to meet our needs or be on terms acceptable to us. This risk may increase if economic and market conditions deteriorate. If we are unable to obtain additional financing when needed, we may need to terminate, significantly modify, or delay the development of our U.S. product candidate, or we may need to obtain funds through collaborations or otherwise on terms that may require us to relinquish rights to our technologies or our U.S. product candidates that we might otherwise seek to develop or commercialize independently. If we are unable to raise adequate additional capital as and when required in the future, we could be forced to cease development activities and terminate our operations, and you could experience a complete loss of your investment.
We expect to continue to make substantial investments in our ongoing commercialization of our products and the pivotal trial that is designed to provide clinical evidence of the safety and effectiveness of our U.S. product candidate, FemBloc. We also expect to continue to make investments in research and development to develop future products, manufacturing, regulatory affairs and post-market clinical trials. We will additionally need to make investments in our sales and marketing organization for FemaSeed and FemBloc. Because of these and other factors, we expect to continue to incur substantial net losses and negative cash flows from operations for the foreseeable future.
Our future capital requirements will depend on many factors, including:
•
the cost, timing and results of our clinical trial and U.S. regulatory reviews;
•
the cost and timing of establishing sales, marketing, and distribution capabilities;
•
the timing, receipt, and amount of sales from our current and potential products;
•
our ability to continue manufacturing our products and U.S. product candidate and to secure the components, services, and supplies needed in their production;
•
the degree of success we experience in commercializing our products;
•
the emergence of competing or complementary technologies;
•
the cost of preparing, filing, prosecuting, maintaining, defending, and enforcing any patent claims and other intellectual property rights; and
•
the extent to which we acquire or invest in businesses, products, or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.
Cash Flows
Comparison of the Nine Months Ended
September
30, 2025 and 2024
The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:
| Nine Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
|
Net cash used in operating activities
|
$ | (14,505,325 | ) | (14,369,440 | ) | |||
|
Net cash used in investing activities
|
(433,383 | ) | (737,151 | ) | ||||
|
Net cash provided by financing activities
|
16,055,985 | 1,001,724 | ||||||
|
Net change in cash and cash equivalents
|
$ | 1,117,277 | (14,104,867 | ) | ||||
Operating activities
For the nine months ended September 30, 2025, cash used in operating activities was $14,505,325, attributable to a net loss of $14,677,582 and a net change in our net operating assets and liabilities of $2,420,824, partially offset by non-cash charges of $2,593,081. Non-cash charges primarily consisted of $1,173,153 in amortization of the discount on convertible notes, $723,722 in share-based compensation, $386,198 in right-of-use asset amortization, $256,835 in depreciation and amortization and $53,173 in loss on property and equipment dispositions. The change in our net operating assets and liabilities was primarily due to increases in inventory of $2,737,651 and accounts receivable of $83,826, decreases in lease liabilities of $392,850, accrued expenses of $122,588 and other liabilities of $23,694, partially offset by an increase in accounts payable of $656,403 and decreases in prepaid and other assets of $283,382. We intend to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in
Funding requirements
.
For the nine months ended September 30, 2024, cash used in operating activities was $14,369,440, attributable to a net loss of $13,692,944 and a net change in our net operating assets and liabilities of $2,495,147, partially offset by non-cash charges of $1,818,651. Non-cash charges primarily consisted of $854,902 in amortization of the discount on convertible notes, $438,601 in right-of-use amortization, $310,004 in share-based compensation and $215,144 in depreciation and amortization. The change in our net operating assets and liabilities was primarily due to decreases in accounts payable and accrued expenses of $368,450, lease liabilities of $273,734, and increases of inventory of $1,270,552, prepaid and other assets of $266,518 and accounts receivable of $279,384.
Investing activities
For the nine months ended September 30, 2025, cash used in investing activities for the purchase of property and equipment and acquisition of patents was $433,383.
For the nine months ended September 30, 2024, cash used in investing activities for the purchase of property and equipment and acquisition of patents was $737,151.
Financing activities
For the nine months ended September 30, 2025, cash provided by financing activities was $16,055,985, attributable to $5,331,887 in proceeds from sales under the at-the-market facility, net of issuance costs, proceeds of $3,705,061 from the June 2025 financing, net of issuance costs, proceeds of $7,069,123 from the August 2025 financing, net of issuance costs and inclusive of exercised warrants and $40,875 in proceeds from the issuance of shares under the ESPP Plan. The proceeds were partially offset by repayment of note payable for $90,961.
For the nine months ended September 30, 2024, cash provided by financing activities was $1,001,724, attributable to proceeds from sales under the at-the-market facility, net of issuance costs and proceeds from the issuance of shares under the ESPP Plan.
Critical Accounting Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.
While our significant accounting policies are more fully described in Note 2 to our financial statements appearing in the Annual Report on Form 10-K for the year ended December 31, 2024 as filed on March 27, 2025, we believe the following discussion addresses our most critical accounting policies, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.
Revenue recognition
Our policy is to recognize revenue when a customer obtains control of the promised goods under Accounting Standards Update (ASU) 2020-05,
Revenue from Contracts with Customers
(Topic 606), which we adopted effective January 1, 2018. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods, and we have elected to exclude amounts collected from customers for all sales (and other similar) taxes from the transaction price. We do not have multiple performance obligations in our customer orders, so revenue is recognized upon shipment of our goods based upon contractually stated pricing at standard payment terms typically ranging from 30 to 60 days. All revenue is recognized at a point in time.
The majority of products sold directly to U.S. customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control at Free on Board (FOB) shipping point. Products shipped to our international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from us. Items to be returned must be in original unopened cartons and are subject to a 30% restocking fee. As of September 30, 2025, we have not had a history of significant returns.
Not applicable.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (2) accumulated and communicated to our management, including to our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial and accounting officer), has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our management has concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2025.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial and accounting officer), does not expect that our disclosure controls and procedures or internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and implemented, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues within a company are detected. The inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple errors or mistakes. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.
PART II OTHER INFORMATION
From time to time we may be involved in legal proceedings arising in connection with our business. As of September 30, 2025, we have not had a history of significant legal proceedings and there are no currently pending actions against us. We believe that any amount, or range, of reasonably possible losses in connection with any potential actions against us in excess of established reserves, in the aggregate, will not be material to our financial condition or cash flows. However, losses may be material to our operating results for any particular future period, depending on the level of income for such period and the significance of any actions against us.
As of the date of this report, there are no material changes to our risk factors as previously disclosed in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 except as noted below.
We have received deficiency letters from Nasdaq relating to our non-compliance with Nasdaq’s continued listing requirements and our common stock could become subject to delisting from Nasdaq if we fail to regain compliance.
On May 19, 2025, we received a written notice from The Nasdaq Stock Market LLC (“Nasdaq”) that for the last 30 consecutive business days, the Market Value of Listed Securities (“MVLS”) for our common stock was below the minimum $35.0 million requirement for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the “Minimum MVLS Requirement”). Additionally, we did not meet either of the alternative Nasdaq continued listing standards under Nasdaq Listing Rule 5550(b)(2): (i) stockholders’ equity of at least $2.5 million or (ii) net income of $500,000 in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.
We believe that, after taking into account the August 2025 Financing and subsequent warrant exercises, and based on pro forma financial data available to us, our stockholders’ equity as of October 15, 2025 would have been approximately $5.2 million on a pro forma basis, which meets the minimum of $2.5 million in stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Based on our Form 8-K, dated October 21, 2025, Nasdaq has determined that we comply with the Listing Rule 5550(b)(1). However, if we fail to evidence compliance upon filing its next periodic report we may be subject to delisting.
On July 16, 2025, we received a notice from Nasdaq that we are not in compliance with Nasdaq’s Listing Rule 5550(a)(2), as the minimum bid price of our common stock has been below $1.00 per share for 30 consecutive business days (the “Minimum Bid Price Requirement”).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days, or until January 12, 2026, to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the minimum bid price of our common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event we do not regain compliance with the Minimum Bid Price Requirement by January 12, 2026, we may be eligible for an additional 180-calendar day compliance period if it meets all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provides written notice of its intention to cure the bid deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If we do not regain compliance with the Minimum Bid Price Requirement by the end of the compliance period (or the second compliance period, if applicable), our common stock will become subject to delisting. In the event that we receive notice that its common stock is being delisted, the Nasdaq listing rules permit us to appeal a delisting determination by the Staff to a hearings panel.
We intend to monitor the closing bid price of our common stock and may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement, including initiating a reverse stock split. However, there can be no assurance that we will be able to regain compliance with the Minimum Bid Price Requirement or show continued compliance with the Minimum MVLS Requirement or will otherwise be in compliance with other Nasdaq Listing Rules.
We need substantial additional funding and may be unable to raise capital when needed, which could force us to delay or reduce our commercialization efforts or product development programs.
Based on our current operating plan and giving effect to the November 2025 Financing, our current cash, cash equivalents and revenue are expected to be sufficient to fund our ongoing operations into September 2026. However, we have based these estimates on assumptions that may prove to be incorrect, and we could spend our available financial resources much faster than we currently expect. Any future funding requirements will depend on many factors, including:
•
The initiation, scope, rate of enrollment, progress, success, and cost of our current or future clinical trials;
•
The cost of our research and development activities;
•
Patient, healthcare practitioner and market acceptance of our intratubal insemination product and permanent birth control system, both women-specific medical product solutions;
•
The cost of filing and prosecuting patent applications and defending and enforcing our patent or other intellectual property rights;
•
The cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights;
•
The cost and timing of additional regulatory clearances or approvals;
•
The cost and timing of establishing additional sales and marketing capabilities;
•
Costs associated with any product recall that may occur;
•
The effect of competing technological and market developments;
•
The extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; and
•
The costs of operating as a public company.
The majority of the proceeds from the November
2025
Financing will be
used to
repay the November 2023 Convertible Notes. We still need
significant additional financing to fund our product development and
operations. Any additional equity or debt financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds by selling additional shares of our common stock or other securities convertible into or exercisable or exchangeable for shares of our common stock, the issuance of such securities will result in dilution to our stockholders. Furthermore, investors purchasing any securities we may issue in the future may have rights superior to the rights of our common stockholders.
In addition, any future debt financing into which we enter may impose upon us covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Our convertible notes contain restrictions that limit our ability to issue securities without complying with certain participation rights. If we raise additional funds through collaboration and licensing arrangements with third-parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us.
Furthermore, we cannot be certain that additional funding will be available on acceptable terms, if at all. If we do not have, or are not able to obtain, sufficient funds, we may have to delay development or commercialization of our products or license to third-parties the rights to commercialize products or technologies that we would otherwise seek to commercialize. We also may have to reduce commercialization efforts, customer support or other resources devoted to our products or cease operations. Any of these factors could harm our business, financial condition, and results of operations.
Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
None.
None.
Not applicable.
During the period covered by this Quarterly Report,
none
of our directors or executive officers have adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).
The One Big Beautiful Bill Act on July 4, 2025, H.R. 1, or the “One Big Beautiful Bill Act” was signed into law in the U.S., which contains a broad range of tax reform provisions affecting businesses. The Company has determined the legislation will not have material impact on our business.
|
Incorporated by
Reference |
|||||
|
Exhibit
|
|||||
|
Number
|
Description of Document | Schedule/Form |
File
Number |
Exhibit |
Filing
Date |
|
Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc.
|
Form 8-K
|
001-40492
|
3.1
|
June 22, 2021
|
|
|
Amended and Restated Bylaws of Femasys Inc.
|
Form 8-K
|
001-40492
|
3.2
|
June 22, 2021
|
|
|
First Amendment to the Amended and Restated Bylaws of Femasys Inc.
|
Form 8-K
|
001-40492
|
3.1
|
March 30, 2023
|
|
|
Underwriter
Common Stock Purchase Warrant
|
Form 8-K
|
001-40492
|
4.1
|
August 27, 2025 | |
|
Pre-Funded Common Stock Purchase Warrant
|
Form 8-K
|
001-40492
|
4.2
|
August 27, 2025 | |
|
Common Stock Purchase Warrant
|
Form 8-K
|
001-40492
|
4.3
|
August 27, 2025 | |
| 4.4 | Form of Series A-1 Warrant | Form 8-K | 001-40492 | 4.1 | November 3, 2025 |
| 4.5 | Form of Series B-1 Warrant | Form 8-K | 001-40492 | 4.2 | November 3, 2025 |
| 4.6 | Form Series C-1 Warrant | Form 8-K | 001-40492 | 4.3 | November 3, 2025 |
| 4.7 | Forn of Purchase Agreement | Form 8-K | 001-40492 | 10.1 | November 3, 2025 |
| 4.8 | Form of Senior Secured Convertible Note | Form 8-K | 001-40492 | 10.2 | November 3, 2025 |
| 4.9 | Form of Registration Rights Agreement | Form 8-K | 001-40492 | 10.3 | November 3, 2025 |
|
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
|
|||||
|
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
|
|||||
|
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.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
||||
|
101.DEF*
|
Inline XBRL Taxonomy Definition Linkbase 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 XBRL and contained in Exhibit 101)
|
||||
*Filed herewith
Pursuant to the requirements of the Securities Act, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Suwanee, State of Georgia, on this 14
th
day of November 2025.
|
FEMASYS INC
|
||
|
Dated: November 14, 2025
|
By: /s/ Kathy Lee-Sepsick
|
|
|
Kathy Lee-Sepsick
|
||
|
Chief Executive Officer and President
|
|
Dated: November 14, 2025
|
||
|
By: /s/ Dov Elefant
|
||
|
Dov Elefant
|
||
|
Chief Financial Officer
|
TABLE OF CONTENTS
Part I. Financial InformationItem I. Financial StatementsItem 2. Management S Discussion and Analysis Of Financial Condition and Results Of OperationsItem 3. Quantitative and Qualitative Disclosures About Market RiskItem 4. Controls and ProceduresPart II Other InformationItem 1. Legal ProceedingsItem 1A. Risk FactorsItem 2. Unregistered Sales Of Equity Securities, Use Of Proceeds, and Issuer Purchases Of Equity SecuritiesItem 3. Defaults Upon Senior SecuritiesItem 4. Mine Safety DisclosuresItem 5. Other InformationItem 6. Exhibits