FEMY 10-K & 10-Q changes, risk factors and insider trading

We expect that our operating expenses will continue to increase as we continue to build our infrastructure, develop, enhance and commercialize new products and incur additional operational costs associated with being a public company. As a result, we expect to continue to incur operating losses for the foreseeable future and may never achieve profitability. Furthermore, even if we do achieve profitability, we may not be able to sustain or increase profitability on an ongoing basis. If we do not achieve or sustain profitability, it will be more difficult for us to finance our business and accomplish our strategic objectives, either of which would have a material adverse effect on our business, financial condition and results of operations and cause the market price of our common stock to decline. Our current cash position and anticipated revenue are not sufficient to fund our operations through U.S. regulatory approval of FemBloc, our primary product candidate. Completing the FINALE pivotal trial and filing a PMA with the FDA will require us to raise substantial additional capital. The amount and timing of that additional capital requirement will depend on, among other things, the pace of enrolment in the pivotal trial, the cost of our research and development activities, and the timing of any FDA advisory feedback. If we are unable to raise sufficient additional capital when needed, whether through equity offerings, debt financing, or strategic collaboration, we may be required to delay, reduce or cease our clinical development activities, which would materially harm our ability to pursue U.S. commercialization of FemBloc. In addition, failure of our FemBloc solution to be approved to market, or to significantly penetrate existing or new markets with our products would negatively affect our business, financial condition, and results of 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, we are limited under the terms of the convertible notes to sell securities at a price below $1.18 until May 2025, which may limit our ability to raise capital when required.

There are risks associated with our convertible notes and warrants that could adversely affect our business and financial condition.

In November 2023,2025, we issued $6.85$12 million senior unsecuredsecured convertible notes, convertible into shares of common stock at a conversion price of $1.18$0.73 per share. The convertible notes accrue interest at a rate of 6.0% 8.5% per annum, payable annually,annually in cashkind or(“PIK”) sharesby ofincreasing commonthe stockprincipal atbalance ouroutstanding. option,The and2025 Notes mature in November 2025,2035, unless earlier converted or redeemed. There are no assurances that that we will have sufficient funds available to satisfy the payment due under our convertible notes at maturity, or that the holders will elect to convert the convertible notes into shares of our common stock.

The convertible note purchase agreement provides for standard and customary events of default, such as our failing to make timely payments and failing to timely comply with the reporting requirements of the Exchange Act. The convertible notes also contain customary affirmative and negative covenants, including limitations on incurrence of indebtedness, acquisition and investment transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends, distributions or redemptions, and the transfer of assets. Our Incash addition,flow may not be sufficient to allow us to pay the principal and accrued interest at maturity in November 2035. Our ability to make these payments depends on a number of factors, including our operating performance, competitive developments and financial market conditions, all of which are significantly affected by financial, business, economic, and other factors, many of which we are limitednot underable theto termscontrol. The level of our indebtedness under the convertible notes to sellcould securitieshave atother aimportant priceconsequences, belowincluding $1.18 until May 2025.the following:

Delays or failures in planned site initiation and/or subject enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop our U.S. product candidates candidate or could render further development impossible. In addition, we rely on clinical trial sites to ensure timely conduct of our clinical trials and, while we have entered into agreements governing their services, we are limited in our ability to compel their actual performance.

Our current U.S. product candidate, FemBloc is in late-stage of development. Our U.S. product candidate may fail in development or suffer delays that adversely affect its commercial viability. If we fail to obtain or maintain FDA approval to market and sell our FemBloc our business will be materially harmed.

In March 2025, we announced CE mark certification under EU MDR as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control.control Forand thein FemBlocJune blended polymer, an integral part of the FemBloc permanent birth control,2025, we have successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended forannounced CE mark approvalcertification pendingunder EU MDR for the finalclass stagesIII ofblended EMApolymer review,component, with potentialachieving approval expectedfor mid-2025.the entire FemBloc system in the EU. In August and September 2025, we announced UK and New Zealand regulatory approvals, respectively, In March and September 2025, we announced strategic distribution partnerships for FemBloc in Spain.Spain and France/Benelux region, respectively. In February 2026, we announced MDSAP certification for FemBloc.

We have established a direct sales organization with technical expertise in supporting commercial capabilities to market FemaSeed in the U.S. This is expensive and time-consuming. In addition, we may not be able to hire a sales force that is sufficient in size or has adequate expertise in the medical markets that we target. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of FemaSeed and other products and our U.S. product candidates.candidate.

Maintaining third-party relationships for these purposes will impose significant added responsibilities on members of our management and other personnel. We must be able to effectively manage our development efforts, recruit and train sales and marketing personnel, effectively manage our participation in the clinical studies in which our U.S. product candidate and any future product candidates are involved and improve our managerial, development, operational and finance systems, all of which may impose a strain on our administrative and operational infrastructure. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our products.

Since our inception, we have devoted a significant amount of our efforts to the development of our intrauterine delivery technology that is the basis for our FemBloc system. We have not yet received authorization from the FDA to market and sell the FemBloc system in the United States. However, we will incur costs, including costs to build our sales force for commercialization of our other products, in anticipation of FDA authorization to market this system. Since the target service providers for our FDA-cleared FemaSeed product are different than what we anticipate for our FemBloc system, the sales force we are currently building for our FemaSeed product will need to be broadened to service gynecologists for the FemBloc system, and we will need to maintain and support multiple commercialization efforts simultaneously if we are able to market both products, if we obtain authorization for FemBloc. If we are unable to obtain authorization from the FDA to market and sell this system in the United StatesStates, andor thenif the product fails to achieve significant market acceptance in the United States, our results of operations willcould be adversely affected as the United States is expected to berepresent a principal market for this product. Further, because we haveare incurredincurring costs prospectively in advance of FDA authorization, we wouldmay be unable to recoup these costsinvestments if the U.S. product candidate is not authorized for marketing by the FDA. WeWhile have we currently market other commercial products, but their revenuerevenues isremain currentlylimited. minimal, thus,Accordingly, if we are unsuccessful in commercializing the FemBloc system or are unable to market the FemBloc system as a result of a quality problem, failure to maintain or obtain regulatory marketing authorizations, unexpected or serious complications or other unforeseen negative effects related to this system or the other factors discussed in these risk factors, we would lose an additional source of revenue, and our business will be materially adversely affected.

In March 2025, we announced CE mark certification under EU MDR as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control.control Forand thein FemBlocJune blended polymer, an integral part of the FemBloc permanent birth control,2025, we have successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended forannounced CE mark approvalcertification pendingunder EU MDR for the finalclass stagesIII ofblended EMApolymer review,component, with potentialachieving approval expectedfor mid-2025.the entire FemBloc system in the EU. In August and September 2025, we announced UK and New Zealand regulatory approvals, respectively, In March and September 2025, we announced strategic distribution partnerships for FemBloc in Spain.Spain and France/Benelux region, respectively. In February 2026, we announced MDSAP certification for FemBloc.

We are currently seeking PMA approval for our permanent birth control solution. In order to obtain PMA approval for the FemBloc system, we must conduct a well-controlled clinical trial designed to assess the safety and effectiveness of the U.S. product candidate. Conducting clinical trials is a complex and expensive process, can take many years, and outcomes are inherently uncertain. We incur substantial expense for, and devote significant time to, clinical trials but cannot be certain that the trials will ever result in commercial revenue. We may experience significant setbacks in the clinical trial, even after earlier clinical trials showed promising results, and failure can occur at any time during the clinical development process. Any of our products may malfunction or may produce undesirable adverse effects that could cause us, institutional review boards or IRBs, or regulatory authorities to interrupt, delay or halt clinical trials. We, IRBs, the FDA, or another regulatory authority may suspend or terminate the clinical trial at any time to avoid exposing trial participants to unacceptable health risks.

In addition, we may estimate and publicly announce the anticipated timing of the accomplishment of various clinical, regulatory and other product development goals, which are often referred to as milestones. These milestones could include the submission to the FDA of an IDE application to commence a clinical trial for a new product candidate; the enrollment of patients in clinical trials; the release of data from clinical trials; regulatory submissions and decisions, compliance with regulatory requirements in jurisdictions where we market our products, including the European Union, and other clinical and regulatory events; and the obtainment of the right to affix the CE mark in the European Union. The actual timing of these milestones could vary dramatically compared to our estimates, in some cases for reasons beyond our control. We cannot assure you that we will meet our projected milestones and if we do not meet these milestones as publicly announced, the commercialization of our products may be delayed and, as a result, our stock price may decline.

Clinical trials are necessary to support PMA applications, certain de novo classification requests, and certain 510(k) premarketpre-market notifications and may be necessary to support PMA supplements or subsequent 510(k) submissions for modified versions of our marketed devices. This would require the enrollment of large numbers of suitable subjects, which may be difficult to identify, recruit and maintain as participants in the clinical trial. The earlier clinical studies for FemBloc involved 228 subjects and supported the IDE for the new pivotal trial, which will be the basis for the PMA application for our FemBloc system. Adverse outcomes in the IDE approved pivotal trial or post-approval studies could also result in restrictions or withdrawal of approval of the PMA. We will likely need to conduct additional clinical trials in the future for the approval of the use of our products in some foreign countries. Clinical testing is difficult to design and implement, can take many years, can be expensive and carries uncertain outcomes. The initiation and completion of any of these studies may be prevented, delayed, or halted for numerous reasons. We may experience a number of events during the conduct of our clinical trials that could adversely affect the costs, timing or successful completion, including:

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. The Company is a U.S. manufacturer that has received global regulatory approvals for its product portfolio worldwide, and they 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 and Israel. 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 and Israel. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared and approved in Europe, UK, Canada and Israel. FemBloc® permanent birth control is a revolutionary first-of-its-kindfirst-in-class non-surgical approach,solution thatwhich 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 thea safestsafe mostand 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,safe and effective, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost.cost Peer-reviewedthan the surgical alternative. A peer-reviewed publication of positive data from its initial clinical trials of FemBloc havehas 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.control Forand thein FemBlocJune blended polymer, an integral part of the FemBloc permanent birth control,2025, we have successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended forannounced CE mark approvalcertification pendingunder EU MDR for the finalclass stagesIII ofblended EMApolymer review,component, with potentialachieving approval expected mid-2025.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.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) is now enrolling participants for U.S. approval. FemCath®In andMarch FemChec®,2026, we announced the initiation of enrollment in this final phase. FemChec, a companion diagnostic productsproduct for FemBloc’s ultrasound-based confirmation test, areis U.S. FDA-cleared and approved in EuropeEurope, UK, Canada, Israel, Australia and Canada.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 200228 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.

Sales are primarily from the sale of our FemaSeedFemaSeed, FemBloc and FemVue products.

We sell our product to medical centers, including healthcare practitioner offices, primarily through our direct commercial team in the U.S., as well as through distribution partners in select international markets. For Kebomed Europe AG, a distributor in France, accounted for approximately 21% of our revenue for the year ended December 31, 2024,2025. Comercial Medico Quiruigca,Quirugica, SA and Durgalab, distributors in Spain, accounted for approximately 15%8% and 12%,8%, respectively, of our total revenue.revenue for the year ended December 31, 2025, and 15% and 12%, respectively, for the year ended December 31, 2024. For the years ended December 31, 20242025 and 2023,2024, Bayer Yakuhin, Ltd. accounted for approximately 7%3% and 5%,7%, respectively, of our total revenue. For products sold in the U.S. through direct customer service, control is transferred upon shipment to customers. For products sold to distributors internationally, control is transferred upon shipment or delivery to the customer’s named location, based on the contractual shipping terms.

R&D costs are expensed as incurred. In the future, we expect R&D expenses to increase in absolute dollars as we continue to develop our U.S. product candidate FemBloc, expand our product candidate pipeline, enhance our existing products and technologies and perform activities related to obtaining additional regulatory approval.

Other (expense)expense, incomenet

Sales increased by $557,138$664,205 or 52.0%,40.8%, to $2,293,313 in 2025 from $1,629,108 in 2024 from $1,071,970 in 2023.2024. The increase is attributable primarily to FemaSeedFemBloc product sales of $509,650,$810,000, which waswere commercialized in 2024. FemVue units sold increased by 6.9% in 2024 as compared to 2023, while maintaining a relatively flat average selling price.2025.

Cost of sales increased by $164,834,$327,497 or 43.4%,60.1%, to $872,400 in 2025 from $544,903 in 2024 from $380,069 in 2023.2024. The increase in cost of sales is primarily attributed to increased sales,sales partiallyand offsetnewly bycommercialized certain manufacturing efficiencies.products.

General and administrativeR&D expenses decreased by $532,009,$638,839 or 7.8%, to $6,325,999$7,577,704 in 20242025 from $6,858,008$8,216,543 in 2023.2024. The decrease relatesis primarily due to decreasedreduced clinical costs, commercialization of development products into inventory, reduced professional fees, and reduced compensation expense and professionalrelated personnel costs, partially offset by increased facility and other overheadregulatory costs.

Depreciation and amortization expenses decreasedincreased by $186,163,$44,716, or 38.5%,15.0%, to $342,034 in 2025 from $297,318 in 2024 from $483,481 in 2023.2024. The decreaseincrease relates to depreciation expense associated with the Company’sadditional fixed assets and amortization expense associated with the Company’s intangible assets thatin have reached the end of their useful lives.service.

Other (expense)expense, incomenet

Income tax expense increaseddecreased by $5,264$8,305 or 121.3%,86.5%, to $1,297 as compared to $9,602 in 2024 from $4,338 in 2023 due to ana increasedecrease in the state minimum taxes we arewere required to pay.

In July 2022, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler” or 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 offering price up to $16.7 million pursuant to the prospectus. During the year ended December 31, 2024, we sold2025, approximately 1.3 million shares of common stock for aggregate proceeds of $2 million, and as of December 31, 2024, approximately $7.0 million remains available for sale pursuant to the prospectus. As of December 31, 2024, approximately 4.610.2 million shares of common stock have been sold to date for aggregate proceeds of $9.8$16.7 million under the Equity Distribution Agreement pursuant to the prospectus. In December 2025, we filed a new prospectus pursuant to which we may sell up to $9.8 million under the Equity Distribution Agreement. Subsequent to December 31, 2024,2025, we raised approximately $5.4$0.4 million under the Equity Distribution Agreement. Based on our public float, as of the date of the filing of this Annual Report on Form 10-K, we are only permitted to utilize a shelf registration statement, including the registration statement under which our at the market offering is operated, subject to Instruction I.B.6 to Form S-3, which is referred to as the “baby shelf” rule. For so long as our public float is less than $75.0 million, we may not sell more than the equivalent of one-third of our public float during any 12 consecutive months pursuant to the baby shelf rules.

In AprilAugust 2023,2025, we sold an aggregate of (i) 1,318,00010,434,586 shares of common stock in a public offering and to certain Company officers (ii) pre-funded warrants to purchase up to 1,878,72211,750,000 shares of common stock inand a(iii) registered direct offering and, in a concurrent private placement,common warrants to purchase up to 3,196,72222,184,586 shares of common stock. Additionally, common warrants were issued to the placement agent in this transaction to purchase up to 191,803443,692 shares of common stock were issued to the underwriter as compensation for services,services collectively the (“April 2023 Financing”).performed. The purchase price per share for the common stock,stock prefundedwas $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 $1.22 and $1.2199, respectively.$0.3599. The net proceeds from the AprilAugust 20232025 Financing at closing were approximately $3.4$7.1 million. TheAs of December 31, 2025, 5,000,000 pre-funded warrants inand the April9,219,110 2023 Financing were fully exercised for additional cash proceeds of $3.5 million during 2023. Placement agentcommon warrants of 122,994 were exercised for additionalapproximately cash$3.3 proceeds of $0.2 million during 2023.million.

Based on our current operating plan, our current cash and cash equivalents, which include approximately $5.4 million we raised subsequent to year end 2024,equivalents and anticipated revenues from product sales are expected to be sufficient to fund our ongoing operations into the third quarter of 2025.2026. 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.

OurBased on our current operating plan, our cash and cash equivalents as of December 31, 2024,2025, anticipated revenues from product salessales, proceeds from our 2025 financings, and approximately $5.4$0.4 million we raised subsequent to year end, 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. However, we can give no assurances that we will be able to secure additional sources of funds to support our 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. In addition, we are limited under the terms of the convertible notes to sell securities at a price below $1.18 until May 2025. 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 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 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 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, FemaSeed and if approved, 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.

In 2024,2025, cash used in operating activities was $19,444,009,$18,690,565, attributable to a net loss of $18,816,628,$18,627,887 and a net change in our net operating assets and liabilities of $3,144,778, $2,056,843, partially offset by non-cash charges of $2,517,397. $1,994,165. Non-cash charges primarily consisted of $1,192,574$1,387,050 in amortization of the discount on the 2023 and 2025 convertible notes, $872,000$850,456 in depreciation and amortizationamortization, expenses$790,145 in stock-based compensation, $132,140 in accretion of paid-in-kind interest and $62,650 in loss on property and $444,147equipment dispositions, partially offset by a change in stock-basedfair compensation.value of $503,000 and $731,000 of the Conversion Option liability and Warrants liabilities, respectively. The change in our net operating assets and liabilities was primarily due to increases in inventory of $2,693,926 and accounts receivable of $2,379,205$128,227, decreases in inventory,lease $397,467liabilities and inother accountsliabilities receivable,of $139,136$517,967 and $23,178, respectively, partially offset by a decrease in prepaid and other assets, a decreaseassets of $406,636$496,902 and increases in leaseaccrued expenses liabilities,and partiallyaccounts offset by an increasepayable of $207,481$474,724 in accountsand payable.$334,829, Therespectively, CompanyWe intends intend to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements.

In 2023,2024, cash used in operating activities was $11,280,546,$19,444,009, attributable to a net loss of $14,247,124, offset by non-cash charges of $1,739,186 and$18,816,628, a net change in our net operating assets and liabilities of $1,227,392.$3,136,778, partially offset by non-cash charges of $2,509,397. Non-cash charges primarily consisted of $675,700 in stock-based compensation, $907,985 in depreciation and amortization and $107,963$1,192,574 in amortization of the discount on the convertible notes.notes, $872,000 in depreciation and amortization expenses and $444,147 in stock-based compensation. The change in our net operating assets and liabilities was primarily due to an increaseincreases of $1,614,647$2,379,205 in inventory, $389,467 in accounts payablereceivable, $139,136 in prepaid and accruedother assets, a decrease of $406,636 in lease liabilities, partially offset by aan decreaseincrease of $440,489$207,481 in leaseaccounts liabilities.payable. The Company intends to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements.

In 2024,2025, cash used in investing activities for the purchases of fixed assets and intangible assets was $761,706$525,007 and $86,058,$105,091, respectively. In 2023, cash used in investing activities for the purchase of fixed assets was $143,917.

In 2024, cash provided by financing activities was $2,027,457, attributable to sales under the at-the-market facility of $2,025,104$1,964,351, net of issuance costs and proceeds from common stock issued through the employee stock purchase plan of $63,106, less at-the-market facility issuance costs of $60,753.$63,106.

Our policy is to recognize revenue when a customer obtains control of the promised goods under Accounting Standards Codification 606—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. Revenue is recognized upon shipment of the Company’s goods based upon contractually stated pricing at standard payment terms typically ranging from 30 to 60 days. All revenue is recognized at a point in time.

As of 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, 20252025, exceptand asour Quarterly notedReport below.on Form 10-Q for the three months ended March 31, 2026.

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 MarchJune 31,30, 2026. 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.

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. The Company is a U.S. manufacturer that has received global regulatory approvals for ourits product portfolio, which is currently being commercialized in the U.S. and key international markets. FemaSeed® Intratubal Insemination, a groundbreaking first-step 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 setup, preparation and analysis kits designed to expand our infertility portfolio and, for the first time, enable 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. FemHSG™ Catheter, used with FemVue for in-office ultrasound-based evaluation is CE mark approved in Europe. FemVue Controlled is a USU.S. FDA-cleared diagnostic device and is the next-generation design integrating features of FemVue and FemChec® technologies into a single platform, enabling multiple clinical uses within one solution, including confirmation of tubal patency prior to use with FemaSeed. 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 the 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 has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm.

On April 1, 2026, we announced the appointment of John Canning as Chief Operating Officer, who will drive operational execution and support commercial growth.

On April 22,2026,22, 2026, we announced the commercial launch of FemaSeed Complete, a comprehensive fertility solution that enables OB/GYNs to perform first-line insemination entirely within their own practices.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

The following table shows our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

Sales increaseddecreased by $83,625,$77,441, or 24.5%,18.9%, to $424,889$331,827 for the three months ended MarchJune 31,30, 2026 from $341,264$409,268 for the three months ended MarchJune 31,30, 2025, primarily attributable to lower international sales of FemVue.

Cost of sales increaseddecreased by $41,340$15,735 or 35.3%,9.9%, to $158,606$142,436 for the three months ended MarchJune 31,30, 2026 from $117,266$158,171 for the three months ended MarchJune 31,30, 2025, and is primarily attributed to increaseddecreased sales.

R&D expenses decreasedincreased by $1,659,071 $532,449 or 55.9%,37.6%, to $1,309,401$1,946,878 for the three months ended MarchJune 31,30, 2026 from $2,968,472$1,414,429 for the three months ended MarchJune 31,30, 2025. The decrease increase primarily reflects the transition of development products into inventory to support commercialization,commercialization alongduring with2025, lowerand development,increased clinical,clinical costs, partially offset by reduced compensation and professional service costs.

Sales and marketing expenses increased by $407,188$309,021 or 44.8%,31.4%, to $1,315,755$1,293,998 for the three months ended MarchJune 31,30, 2026 from $908,567$984,977 for the three months ended MarchJune 31,30, 2025. The increase resulted primarily from higher compensation costs, professional feescosts and travel expenses.

General and administrative expenses increased by $59,677,$314,606, or 3.5%,19.5%, to $1,782,390$1,931,578 for the three months ended MarchJune 31,30, 2026 from $1,722,713$1,616,972 for the three months ended MarchJune 31,30, 2025. The increase resulted primarily from increased professional fees, offset by reduced compensation costs and facility costs.

Depreciation and amortization expenses decreased by $2,583,$3,474, or 3.0%,4.0%, to $82,270$82,811 for the three months ended MarchJune 31,30, 2026 from $84,853$86,285 for the three months ended MarchJune 31,30, 2025. The decrease resulted from certain fixed assets reaching the end of their useful lives and no longer depreciating.

Other income (expense), net increased by $5,510,053$1,332,000 or 1,251.1%,181.4%, to $5,069,633$597,644 of income for the three months ended MarchJune 31,30, 2026 from $440,420$734,356 of expense for the three months ended MarchJune 31,30, 2025. The increase resulted from the change in fair value on the Conversion Option liability and Warrants liabilities, interest income earned on our cash and cash equivalents andequivalents, reduced non-cash interest expense related to amortization for our convertible note.notes and debt issuance costs incurred in 2025. Refer to the table below for further details.

Income tax benefitexpense decreased increased by $4,188$865 or 100%, to $865 for the three months ended June 30, 2026 from $0 for the three months ended MarchJune 31, 2026 from $4,188 for the three months ended March 31,30, 2025 due to an estimation of lowerhigher income tax expense in the firstsecond quarter of 2026 as compared to 2025.

Since our inception through MarchJune 31,30, 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 MarchJune 31,30, 2026, we had $5,386,041$1,443,502 of cash and cash equivalents and an accumulated deficit of $144,980,044.$149,449,139.

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 MarchJune 31,30, 2026, approximately 624,00031,195 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 MarchJune 31,30, 2026, the amount we were authorized to sell was subject to baby-shelf limitations. As of MarchJune 31,30, 2026, the available amount pursuant to the prospectus was approximately $9.5$9.4 million.

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 the 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 4the four previous business days, multiplied by 90%, or (ii) up to the lesser of (a) $1 million in shares of common stock, or (b) 100% of the average daily trading volume of common stock for the previous two business days at the lowest daily dollar volume-weighted average price, multiplied by 97%. We are limited to issuances to Alumni or of 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) 10,434,586521,731 shares of common stock in a public offering and to certain Company officers (ii) pre-funded warrants to purchase up to 11,750,000587,500 shares of common stock and (iii) common warrants to purchase up to 22,184,5861,109,237 shares of common stock. Additionally, common warrants to purchase 443,69222,185 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,$7.20, except for shares sold to certain company officers, which was $0.5151$10.31 per share. The purchase price per share for the pre-funded warrants was $0.3599.$7.20. The net proceeds from the August 2025 Financing at closing were approximately $7.1 million. As of MarchJune 31,30, 2026, 5,000,000250,000 pre-funded warrants and 9,219,110460,959 common warrants were exercised for approximately $3.3 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 818,544 shares of 16,378,563 common stock at a conversion price of $0.73$14.66 per share, (ii) Series A-1 Warrants to purchase up to an aggregate of 16,378,563818,937 shares of common stock at an exercise price of $0.81$16.20 per share, subject to adjustments (iii) Series B-1 Warrants to purchase an aggregate of 16,378,563818,937 shares of common stock at an exercise price of $0.92$18.40 per share, subject to adjustments, and (iv) Series C-1 Warrants to purchase an aggregate of 16,378,563818,937 shares of common stock at an exercise price of $1.10$22.00 per share, subject to adjustments. The financing resulted in aggregate gross proceeds of $12,000,000, with total potential funding of approximately $58 million,adjustments, 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 16,378,563818,937 shares of the Company’s common stock at an exercise price of $0.58$11.60 per share. The financing resulted in aggregate gross proceeds of $12,000,000, with total potential funding of approximately $68 million, including the D-1 Warrants. In April 2026, shareholders approved the issuance of shares of common stock issuable upon conversion of the 2025 Notes and exercise of Series A-1, B-1, C-1, and D-1 Warrants, including any issuances to directors and officers of the Company who are holders of these instruments, in excess of 19.99% of the issued and outstanding shares of common stock of the Company (to the extent that anti-dilution or price adjustment provisions in the instruments result in an effective conversion or exercise price below the Nasdaq Minimum Price).

Based on our current operating plan, our current cash and cash equivalentsequivalents, proceeds from our recently completed private placement of $30 million, and anticipated revenues from product sales are expected to be sufficient to fund our ongoing operations intofor theat third quarter of 2026. However, it is not sufficient to fund our ongoing operations forleast twelve months from the date of these financial statements and we will need to obtain additional financing to fund our ongoing operations.months. 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. AsIf awe resultare unable to obtain additional financing when needed, we may need to terminate, significantly modify, or delay the development of our currentU.S. limitedproduct financialcandidate, liquidity,or we havemay concludedneed to obtain funds through collaborations or otherwise on terms that substantialmay doubtrequire existsus aboutto relinquish rights to our abilitytechnologies or our U.S. product candidate that we might otherwise seek to continuedevelop 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 goingcomplete concern.loss of your investment.

Comparison of the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025

The following table summarizes our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

For the threesix months ended March 31,June 30, 2026, cash used in operating activities was $4,143,508,$8,079,197, attributable to net incomeloss of $846,100, offset by$3,622,995, net non-cash gains of $4,667,748$4,837,472 and a net change in our net operating assets and liabilities of $321,860.$381,270. Non-cash activity primarily consisted of a change in fair value of the Conversion Option liability and warrants liabilities of $1,513,413$1,732,413 and $3,683,000,$4,228,000, respectively, $176,607 $362,657 of amortization of the discount on convertible notes, $151,608$362,428 in share-based compensation, $118,180$232,775 in right-of-use asset amortization and $82,270$165,081 in depreciation and amortization. The change in our net operating assets and liabilities was primarily due to increases in accounts payable of $499,250, decreases in accounts receivable of $465,551 and prepaid and other assets of $308,488, offset by an increase in inventory of $365,018, $451,028 and decreases in accountslease payableliabilities of $253,439,$249,081 and 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.$184,220. We intend to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements.

For the threesix months ended MarchJune 31,30, 2025, cash used in operating activities was $4,765,214,$9,117,950, attributable to a net loss of $5,896,839, partially offset by non-cash charges of $984,503$10,482,761 and a net change in our net operating assets and liabilities of $147,122.$416,139, partially offset by non-cash charges of $1,780,950. Non-cash charges primarily consisted of $367,237 in share-based compensation, $356,699$746,612 in amortization of the discount on convertible notes, $132,207$549,208 in share-based compensation, $260,819 in right-of-use asset amortizationamortization, and $84,853$171,138 in depreciation and amortization.amortization and $53,173 in loss on property and equipment dispositions. The change in our net operating assets and liabilities was primarily due to a decreaseincreases in accounts receivableinventory of $254,775$2,186,415, and an increasedecreases in accountslease payableliabilities of $264,580 and accrued expenses of $909,917,$98,297, partially offset by an increase in inventoryaccounts payable of $815,865,$1,758,162 aand decreasedecreases in leaseaccounts liabilitiesreceivable of $133,076$233,789 and increase in prepaid and other assets of $53,523.$165,056. TheWe Company intendsintend to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements.