Femasys Inc: Form 10-Q for the period ended Sep 30, 2025

Management’s Discussion and Analysis of Financial Condition and Results of Operations

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:

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:

22

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:

23

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:

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:

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.

Controls and Procedures

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.

Risk Factors

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.