FEMY

FEMASYS INC

NASDAQ · HEALTH CARE · SURGICAL & MEDICAL INSTRUMENTS & APPARATUS

1.41

−0.09 −6.00%

USD · close Oct 26

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MKT CAP $11.8MP/E —DIV YIELD —FCF YIELD -153.06%REV TTM $2.3M +21.9%NET INCOME −$11.8MNET CASH —52W 1.41 – 20.80SEC XBRL · TTM TO Invalid Date

How FEMY rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

84%

of sentences unchanged

Added

108

new sentences

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sentences removed

Length

+1,428

words, now 35,722

New in FY2025

For the years ended December 31, 2025 and December 31, 2024, we had net losses of $18,627,887 and $18,816,628, respectively.
As of December 31, 2025, we had an accumulated deficit of $145,826,144.
Based on our current operating plan, our current cash and cash equivalents, which includes approximately $0.4 million we raised subsequent to year end, and revenue are expected to be sufficient to fund our ongoing operations into the third quarter of 2026.
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.
Based on our current operating plan, our current cash, cash equivalents and revenue are expected to be sufficient to fund our ongoing operations into the third quarter of 2026.
Any future funding requirements will depend on many factors, including: • The initiation, scope, rate of enrollment, progress, success, and cost of our current or future clinical trials; • The cost of our research and development activities; • Patient, healthcare practitioner and market acceptance of our intratubal insemination product and permanent birth control system women-specific medical product solutions; • The cost of filing and prosecuting patent applications and defending and enforcing our patent or other intellectual property rights; • The cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights; • The cost and timing of additional regulatory clearances, de novo grants or approvals; • The cost and timing of establishing additional sales and marketing capabilities; • Costs associated with any product recall that may occur; • The effect of competing technological and market developments; • The extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; and • The costs of operating as a public company.
Our ability to raise capital through equity offerings is currently subject to significant structural constraints.
In July 2025, we filed a shelf registration statement on Form S-3 pursuant to which we may offer and sell up to $150 million in common stock, debt securities, and warrants.
However, because our public float is currently below $75.0 million, we are subject to the limitations imposed by Instruction I.B.6 to Form S-3, commonly referred to as the "baby shelf" rule.
For so long as our public float remains below $75.0 million, we may not sell more than the equivalent of one-third of our public float in any 12 consecutive months pursuant to a shelf registration statement, including through our at-the-market offering facility with Piper Sandler & Co.
In December 2025, we filed a new prospectus pursuant to which we may sell up to $9.8 million under the at-the-market facility, subject to those baby shelf limitations.
While we also have access to additional potential sources of capital (including the Any Market Purchase Agreement with Alumni Capital LP, pursuant to which we may sell up to an aggregate of $10 million in shares of common stock, and the three series of warrants to purchase up to an aggregate of 49,135,689 shares of common stock issued in connection with our November 2025 financing), we cannot guarantee that those facilities will be utilized or sufficient to meet our funding needs.
Sales under the at-the-market facility and the Alumni agreement are subject to market conditions and trading volume limitations.
Until our public float exceeds $75.0 million, our available shelf capacity will remain constrained, and we may be unable to raise capital quickly or in sufficient amounts to meet our operating requirements.
If we are unable to access additional funding on acceptable terms, we may need to delay, significantly modify or cease our clinical and commercial activities.
There are risks associated with our convertible notes and warrants that could adversely affect our business and financial condition.
In November 2025, we issued $12 million senior secured convertible notes, convertible into shares of common stock at a conversion price of $0.73 per share.
The convertible notes accrue interest at a rate of 8.5% per annum, payable annually in kind (“PIK”) by increasing the principal balance outstanding.
The 2025 Notes mature in November 2035, unless earlier converted or redeemed.
Our cash flow may not be sufficient to allow us to pay the principal and accrued interest at maturity in November 2035.
The level of our indebtedness under the convertible notes could have other important consequences, including the following: • We may need to use a substantial portion of our cash flow from operations to pay interest and principal on the convertible notes, which would reduce funds available to us for other purposes such as product development and operations; • If we do not have sufficient cash to pay the principal and accrued interest on the convertible notes at maturity, we may be unable to refinance such indebtedness on terms favorable to us or at all; • Conversion of the convertible notes could result in significant dilution of our common stock and cause the market price of our common stock to decline.
Our capital structure gives rise to a significant and compounding risk of dilution to existing stockholders.
The outstanding principal amount of the 2025 Notes at issuance is convertible into approximately 16,378,563 shares of common stock.
As noted above, the 2025 Notes accrue PIK interest at a rate of 8.5% per annum, by increasing the principal balance outstanding annually.
This means the outstanding principal balance on which conversion shares are calculated will increase by approximately $1,020,000 in the first year, with further compounding in each subsequent year through maturity in November 2035.
Over the ten-year term of the 2025 Notes, the cumulative effect of PIK interest compounding could result in the 2025 Notes being convertible into a materially greater number of shares than the 16,378,563 currently contemplated.
In connection with the November 2025 financing, we also issued three series of warrants to purchase an aggregate of 49,135,689 shares of our common stock at exercise prices ranging from $0.81 to $1.10 per share.
These warrants are immediately exercisable and, in the case of the Series A-1 Warrants, expire ten years from the date of issuance.
Taken together, if the 2025 Notes were fully converted at the current conversion price and all three series of warrants issued in connection with the November 2025 financing were exercised in full, the aggregate number of shares issuable would be approximately 65,694, 606 , representing a substantial increase from the 59,602,787 shares of common stock outstanding as of December 31, 2025.
This dilution could be further compounded by: (i) future issuances under our at-the-market offering facility; (ii) issuances under the Alumni Capital Any Market Purchase Agreement; and (iii) the exercise of the remaining 26,280,425 warrants outstanding, including pre-funded warrants, from our prior financings.
Any such dilution could cause the market price of our common stock to decline significantly.
Investors should be aware that conversion of the 2025 Notes and exercise of the warrants are entirely at the election of the holders (or in the case of certain forced conversion and forced exercise provisions, at our election or automatically upon specified events), and that we cannot predict when or whether any such events will occur.
We cannot assure you that the holders will not elect to convert or exercise their instruments at times that are disadvantageous to existing stockholders, including at times when we may be seeking to raise additional equity capital.
Other factors that may cause fluctuations in our quarterly and annual results include: • Patient and healthcare practitioner adoption of our FemBloc system, if approved to market in the U.S.; • Patient and healthcare practitioner adoption of our FemaSeed product in the U.S.; • Changes in coverage policies by third-party payors that affect the U.S. reimbursement of procedures using our products; • Unanticipated pricing pressure; • The hiring, retention and continued productivity of sales representatives for domestic commercial team; • Our ability to expand the geographic reach of our sales and marketing efforts; • Our ability to obtain regulatory clearance or approval for any products in development or for our current products for additional indications or in additional countries outside the United States; • Results of clinical research and trials on our existing products and products in development; • Delays in receipt of anticipated purchase orders; • Delays in, or failure of, component and raw material deliveries by our suppliers; and • Positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry.
We have received deficiency notices from Nasdaq relating to our non-compliance with Nasdaq's continued listing requirements and our common stock could become subject to delisting from Nasdaq if we fail to regain compliance.
On May 19, 2025, we received a written notice from Nasdaq that for the preceding 30 consecutive business days, the Market Value of Listed Securities ("MVLS") for our common stock was below the minimum $35.0 million requirement for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2).
We also did not meet either of the alternative continued listing standards under Nasdaq Listing Rule 5550(b): (i) stockholders' equity of at least $2.5 million or (ii) net income of $500,000 in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

and 68 more.

Gone since FY2024

For the years ended December 31, 2024 and December 31, 2023, we had net losses of $18,816,628 and $14,247,124, respectively.
As of December 31, 2024, we had an accumulated deficit of $127,198,257.
Based on our current operating plan, our current cash and cash equivalents, which includes approximately $5.4 million we raised subsequent to year end, and revenue are expected to be sufficient to fund our ongoing operations into the third quarter of 2025.
Based on our current operating plan, our current cash, cash equivalents and revenue are expected to be sufficient to fund our ongoing operations into the third quarter of 2025.
Any future funding requirements will depend on many factors, including: • The initiation, scope, rate of enrollment, progress, success, and cost of our current or future clinical trials; • The cost of our research and development activities; • Patient, healthcare practitioner and market acceptance of our intrauterine artificial insemination product and permanent birth control system women-specific medical product solutions; • The cost of filing and prosecuting patent applications and defending and enforcing our patent or other intellectual property rights; • The cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights; • The cost and timing of additional regulatory clearances, de novo grants or approvals; • The cost and timing of establishing additional sales and marketing capabilities; • Costs associated with any product recall that may occur; • The effect of competing technological and market developments; • The extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; and • The costs of operating as a public company.
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 that could adversely affect our business and financial condition.
In November 2023, we issued $6.85 million senior unsecured convertible notes, convertible into shares of common stock at a conversion price of $1.18 per share.
The convertible notes accrue interest at a rate of 6.0% per annum, payable annually, in cash or shares of common stock at our option, and mature in November 2025, unless earlier converted or redeemed.
In addition, we are limited under the terms of the convertible notes to sell securities at a price below $1.18 until May 2025.
Our cash flow may not be sufficient to allow us to pay interest on the convertible notes or pay the principal amount at maturity in November 2025.
The level of our indebtedness under the convertible notes could have other important consequences, including the following: • We may need to use a substantial portion of our cash flow from operations to pay interest and principal on the convertible notes, which would reduce funds available to us for other purposes such as product development and operations; • If we do not have sufficient cash to pay the principal on the convertible notes at maturity, we may be unable to refinance such indebtedness on terms favorable to us or at all; • Our ability to pay interest in shares of our common stock, if so elected by us, and conversion of the convertible notes could result in significant dilution of our common stock, which could result in significant dilution to our existing stockholders and cause the market price of our common stock to decline.
Other factors that may cause fluctuations in our quarterly and annual results include: • Patient and healthcare practitioner adoption of our FemBloc system, if approved to market; • Patient and healthcare practitioner adoption of our FemaSeed product; • Changes in coverage policies by third-party payors that affect the reimbursement of procedures using our products; • Unanticipated pricing pressure; • The hiring, retention and continued productivity of sales representatives; • Our ability to expand the geographic reach of our sales and marketing efforts; • Our ability to obtain regulatory clearance or approval for any products in development or for our current products for additional indications or in additional countries outside the United States; • Results of clinical research and trials on our existing products and products in development; • Delays in receipt of anticipated purchase orders; • Delays in, or failure of, component and raw material deliveries by our suppliers; and • Positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry.
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 product candidates or could render further development impossible.
Our current product candidate, FemBloc is in late-stage of development.
Our product candidate may fail in development or suffer delays that adversely affect its commercial viability.
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.
For the FemBloc blended polymer, an integral part of the FemBloc permanent birth control, we have successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended for CE mark approval pending the final stages of EMA review, with potential approval expected mid-2025.
In March 2025, we announced strategic distribution partnerships for FemBloc in Spain.
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 product candidates.
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 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.
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.
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 States and then to achieve significant market acceptance in the United States, our results of operations will be adversely affected as the United States is expected to be a principal market for this product.
Further, because we have incurred costs prospectively in advance of FDA authorization, we would be unable to recoup these costs if the product candidate is not authorized for marketing by the FDA.
We have other commercial products, but their revenue is currently minimal, thus, 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 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 product candidate.
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; and other clinical and regulatory events; and the obtainment of the right to affix the CE mark in the European Union.
Clinical trials are necessary to support PMA applications, certain de novo classification requests, and certain 510(k) premarket notifications and may be necessary to support PMA supplements or subsequent 510(k) submissions for modified versions of our marketed devices.
With respect to FemaSeed, we intend to focus our sales, marketing and training efforts initially on reproductive endocrinologist physicians with possible expansion to gynecologists who are often the initial point of contact for patients with infertility needs.
The primary customers for our products are reproductive endocrinologists for our infertility products and gynecological physicians, related healthcare professionals, and women’s healthcare provider organizations.
We manufacture and assemble components for our products and product candidates, and a loss or degradation in the performance of our manufacturing capabilities could have a material adverse effect on our business, financial condition and results of operations.
As a result, we do not have long-term committed arrangements with respect to certain of the materials for our products and product candidates and other materials.
If we obtain marketing approval, grant or clearance for our product candidates, we will need to establish an agreement for the commercial manufacture of certain key materials with a third party.
In addition, some of the materials that we use to manufacture our product candidates are complex materials, which may be more difficult to substitute.
Moreover, we rely on third-party sterilizers to effectively sterilize our products and product candidates and failure of any third-party sterilizer could result in safety risks associated with our products and product candidates and could result in patient or study subject injuries which could expose our company to product liability claims and actions.
Additionally, the closures and potential closures of facilities that use ethylene oxide to sterilize medical devices prior to their use may create delays or interruptions in the supply chain for our products and product candidates.
Any compliance failures at any contract sterilizers we may contract with for sterilization of our products and product candidates also could create supply chain delays and interruptions and may require that we identify and contract with alternative contract sterilizers which we may not be able to do timely or on terms favorable to us.
We currently sell primarily our FemaSeed device and FemVue device through a direct effort in the U.S., that targets healthcare practitioner reproductive endocrinologist healthcare practitioners.

and 22 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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