FEMASYS INC

Previous wording

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,…

Excerpt shortened here; the source contains the full paragraph.

Current wording

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. We received FDA approval in November 2025 of our investigational device exemption (“IDE”) supplement to move forward to the final phase of the pivotal clinical trial (clinicaltrials.gov: NCT05977751) for U.S. approval. In March 2026, we announced the initiation of enrollment in this final phase. 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 approximately 228 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 …

Excerpt shortened here; the source contains the full paragraph.

Previous wording

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.

Current wording

Sales increased by $83,625, or 24.5%, to $424,889 for the three months ended March 31, 2026 from $341,264 for the three months ended March 31, 2025, primarily attributable to sales of FemVue.

Previous wording

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.

Current wording

Cost of sales increased by $41,340 or 35.3%, to $158,606 for the three months ended March 31, 2026 from $117,266 for the three months ended March 31, 2025, and is primarily attributed to increased sales.

Previous wording

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.

Current wording

General and administrative expenses increased by $59,677, or 3.5%, to $1,782,390 for the three months ended March 31, 2026 from $1,722,713 for the three months ended March 31, 2025. The increase resulted primarily from increased professional fees, offset by reduced compensation costs.

Previous wording

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.

Current wording

Income tax benefit decreased by $4,188 or 100%, to $0 for the three months ended March 31, 2026 from $4,188 for the three months ended March 31, 2025 due to an estimation of lower income tax expense in the first quarter of 2026 compared to 2025.

Previous wording

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.

Current wording

Since our inception through March 31, 2026, 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 March 31, 2026, we had $5,386,041 of cash and cash equivalents and an accumulated deficit of $144,980,044.

Previous wording

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.

Current wording

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. In December 2025, we filed a new prospectus pursuant to which we may sell up to $9.8 million under the Equity Distribution Agreement. As of March 31, 2026, approximately 624,000 shares of common stock had been sold for aggregate proceeds of approximately $353,000 under the Equity Distribution Agreement pursuant to the prospectus. As of March 31, 2026, the amount we were authorized to sell was subject to baby-shelf limitations. As of March 31, 2026, the available amount pursuant to the prospectus was approximately $9.5 million.

Previous wording

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.

Current wording

On June 30, 2025, we entered into an Any Market Purchase Agreement (“Purchase Agreement” or “AMPA”) 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.

Previous wording

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.

Current wording

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. As of March 31, 2026, 5,000,000 pre-funded warrants and 9,219,110 common warrants were exercised for approximately $3.3 million.

Previous wording

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.

Current wording

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 approximately $58 million, if all warrants are exercised for cash. In March 2026, we modified the November 2025 agreement to remove the non-standard adjustment to the conversion price of the notes and exercise prices of the Series A-1 Warrants, Series B-1 Warrants and Series C-1 Warrants, respectively, upon a Share Combination Event. As consideration for this modification, the Company issued the holders of the 2025 Notes and related Warrants new Series D-1 Warrants which allow the holders to purchase an aggregate number of 16,378,563 shares of the Company’s common stock at an exercise price of $0.58 per share.

Previous wording

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.

Current wording

Based on our current operating plan, our current cash and cash equivalents and anticipated revenues from product sales are expected to be sufficient to fund our ongoing operations into the third quarter of 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.

Previous wording

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 willbe 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.

Current wording

Our cash and cash equivalents as of March 31, 2026, anticipated revenues from product sales will not be sufficient to sustain our operations, including funding our U.S. product candidate, FemBloc through regulatory approval, and we will need to raise additional capital to complete the U.S. development and EU commercialization of our product candidate and U.S. commercialization of our fertility portfolio, including FemaSeed. 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 candidate 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 and commercialization activities and terminate our operations, and you could experience a complete loss of your investment.

Previous wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:

Current wording

The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025:

Previous wording

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.

Current wording

For the three months ended March 31, 2026, cash used in operating activities was $4,143,508, attributable to net income of $846,100, offset by net non-cash gains of $4,667,748 and a net change in our net operating assets and liabilities of $321,860. Non-cash activity primarily consisted of a change in fair value of the Conversion Option liability and warrants liabilities of $1,513,413 and $3,683,000, respectively, $176,607 of amortization of the discount on convertible notes, $151,608 in share-based compensation, $118,180 in right-of-use asset amortization and $82,270 in depreciation and amortization. The change in our net operating assets and liabilities was primarily due to an increase in inventory of $365,018, decreases in accounts payable of $253,439, accrued expenses of $193,226, lease liabilities of $125,280, offset by a decrease in accounts receivable of $444,336 and decreases in prepaid and other assets of $168,722. We intend to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed inFunding requirements.

Previous wording

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.

Current wording

For the three months ended March 31, 2025, cash used in operating activities was $4,765,214, attributable to a net loss of $5,896,839, partially offset by non-cash charges of $984,503 and a net change in our net operating assets and liabilities of $147,122. Non-cash charges primarily consisted of $367,237 in share-based compensation, $356,699 in amortization of the discount on convertible notes, $132,207 in right-of-use asset amortization and $84,853 in depreciation and amortization. The change in our net operating assets and liabilities was primarily due to a decrease in accounts receivable of $254,775 and an increase in accounts payable and accrued expenses of $909,917, partially offset by an increase in inventory of $815,865, a decrease in lease liabilities of $133,076 and increase in prepaid and other assets of $53,523. The Company intends to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements.

Previous wording

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.

Current wording

For the three months ended March 31, 2026, cash used in investing activities for the purchase of property and equipment was $79,138.

Previous wording

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.

Current wording

For the three months ended March 31, 2025, cash used in investing activities for the purchase of property and equipment was $96,605.

Previous wording

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.

Current wording

For the three months ended March 31, 2026, cash provided by financing activities was $342,334, attributable to proceeds from sales under the at-the-market facility, net of issuance costs.