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. 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 safer, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost. 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 March 2025, we announced strategic distribution partnerships for FemBloc in Spain. The pivotal clinical trial (clinicaltrials.gov: NCT05977751) is now enrolling participants for U.S. approval. FemChec®, is a com…

Excerpt shortened here; the source contains the full paragraph.

Current 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.

Previous wording

On May 30, 2025, we announced pricing of an underwritten public offering and concurrent private placement with gross proceeds of $4.5 million.

Current wording

On August 25, 2025, we announced an underwritten public offering with gross proceeds of $8.0 million.

Previous wording

Cost of sales increased by $85,046 or 116.3%, to $158,171 for the three months ended June 30, 2025, from $73,125 for the three months ended June 30, 2024, and is attributed to increased sales.

Current 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.

Previous wording

R&D expenses decreased by $561,446 or 28.4%, to $1,414,429 for the three months ended June 30, 2025 from $1,975,875 for the three months ended June 30, 2024. The decrease resulted primarily from the commercialization of development products into inventory and reduced clinical costs, partially offset by increased compensation costs.

Current wording

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.

Previous wording

Depreciation and amortization expenses increased by $18,657, or 27.6%, to $86,285 for the three months ended June 30, 2025 from $67,628 for the three months ended June 30, 2024. The increase resulted from additional fixed assets and intangible assets in service.

Current wording

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.

Previous wording

Other expense, net increased by $530,183, or 259.7%, to $734,356 for the three months ended June 30, 2025 from $204,173 for the three months ended June 30, 2024. The increase resulted from increased non-cash discount amortization related to the convertible notes payable and expenses related to the Any Market Purchase Agreement, offset by reduced interest income.

Current wording

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.

Previous wording

Income tax benefit decreased by $1,750 or 100%, to $0 for the three months ended June 30, 2025 from $1,750 for the three months ended June 30, 2024 due to an adjustment in the state minimum taxes we are required to pay.

Current 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.

Previous wording

The following table shows our results of operations for the six months ended June 30, 2025 and 2024:

Current wording

The following table shows our results of operations for the nine months ended September 30, 2025 and 2024:

Previous wording

Cost of sales increased by $113,780 or 70.4%, to $275,437 for the six months ended June 30, 2025 from $161,657 for the six months ended June 30, 2024. The increase is primarily attributed to increased sales,

Current wording

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.

Previous wording

Sales and marketing expenses increased by $617,867 or 48.4%, to $1,893,544 for the six months ended June 30, 2025 from $1,275,677 for the six months ended June 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.

Current wording

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.

Previous wording

General and administrative expenses increased by $225,064, or 7.2%, to $3,339,685 for the six months ended June 30, 2025 from $3,114,621 for the six months ended June 30, 2024. The increase relates primarily to increased compensation costs and professional fees.

Current wording

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.

Previous wording

Depreciation and amortization expenses increased by $32,282, or 23.2%, to $171,138 for the six months ended June 30, 2025 from $138,856 for the six months ended June 30, 2024. The increase resulted from additional fixed assets and intangible assets in service.

Current wording

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.

Previous wording

Other expense, net increased by $833,735, or 244.5%, to $1,174,776 for the six months ended June 30, 2025 from $341,041 for the six months ended June 30, 2024. The increase resulted from increased non-cash discount amortization related to the convertible notes payable, and expenses related to the Any Market Purchase Agreement, offset by reduced interest income.

Current wording

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.

Previous wording

Income tax benefit increased by $2,438 or 139.3%, to $4,188 for the six months ended June 30, 2025 from $1,750 for the six months ended June 30, 2024 due to a decrease in the state minimum taxes we are required to pay.

Current wording

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.

Previous wording

Since our inception through June 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 June 30, 2025, we had $3,218,067 of cash and cash equivalents and an accumulated deficit of $137,681,018.

Current 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.

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 June 30, 2025, approximately 8.4 million shares of common stock had been sold for aggregate proceeds of approximately $15.2 million. As of June 30, 2025, the amount we were authorized to sell was subject to baby-shelf limitations. As of June 30, 2025, the available amount pursuant to the prospectus was 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. 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.

Previous wording

In November 2023, we entered into a securities purchase agreement with certain accredited investors pursuant to which we sold (i) senior unsecured convertible 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 to purchase up to an aggregate of 5,805,083 shares of common stock at an exercise price of $1.475 per share (collectively, the “November 2023 Financing”). Net proceeds from the November 2023 Financing were $6.3 million. The Series B Warrants expired in November 2024 unexercised. In April 2025, $85,000 of convertible notes were converted into common stock. If exercised for cash, the Series A Warrants issued in the November 2023 Financing could result in proceeds up to an additional $6.8 million. The Series A Warrants expire in November 2028.

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 $58 million, if all warrants are exercised for cash.

Previous 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 early fourth quarter of 2025. 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, 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.

Previous wording

Our cash and cash equivalents as of June 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. 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 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.

Previous wording

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

Current wording

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

Previous wording

For the six months ended June 30, 2025, cash used in operating activities was $9,117,950, attributable to a net loss of $10,482,761 and a net change in our net operating assets and liabilities of $416,139, partially offset by non-cash charges of $1,780,950. Non-cash charges primarily consisted of $746,612 in amortization of the discount on convertible notes, $549,208 in share-based compensation, $260,819 in right-of-use asset amortization, $171,138 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 $2,186,415, decreases in lease liabilities of $264,580 and accrued expenses of $98,297, partially offset by an increase in accounts payable of $1,758,162 and decreases in accounts receivable of $233,789 and prepaid and other assets of $165,056. We intend to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed inFunding requirements.

Current 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.

Previous wording

For the six months ended June 30, 2024, cash used in operating activities was $8,894,780, attributable to a net loss of $8,284,084 and a net change in our net operating assets and liabilities of $1,774,684, partially offset by non-cash charges of $1,163,988. Non-cash charges primarily consisted of $544,363 in amortization of the discount on convertible notes, $299,171 in right-of-use amortization, $181,598 in share-based compensation and $138,856 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 $781,626, lease liabilities of $137,482, and increases of inventory of $648,462 and prepaid and other assets of $173,828.

Current 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.

Previous wording

For the six months ended June 30, 2025, cash used in investing activities for the purchase of property and equipment and acquisition of patents was $193,567.

Current 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.

Previous wording

For the six months ended June 30, 2024, cash used in investing activities for the purchase of property and equipment and acquisition of patents was $297,123.

Current 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.

Previous wording

For the six months ended June 30, 2025, cash provided by financing activities was $9,077,823, attributable to proceeds from sales under the at-the-market facility, net of issuance costs of $5,331,887, proceeds from the June 2025 financing, net of issuance costs of $3,705,061 and proceeds from the issuance of shares under the ESPP Plan.

Current wording

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.

Previous wording

For the six months ended June 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 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.

Previous wording

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 ranging from 30 to 60 days. All revenue is recognized at a point in time.

Current wording

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.