What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-03-27 compared with 2024-03-28 · 154 added, 235 removed, 139 unchanged (74% of the section changed)

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

We are a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office,

accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products.

Our mission is to provide women with superior minimally-invasive, non-surgical product technologies,

accessible in the office, improving patient care and overall health economics focused on servicing the reproductive health needs for those seeking solutions for infertility issues (FemaSeed and FemVue) or permanent birth control (FemBloc).

a woman-founded and led company with an expansive, internally created intellectual property portfolio with 180 patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to

develop and commercialize products.

Our suite of products and product candidates 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.

FemaSeed – Our Artificial Insemination Solution .

Our FDA-cleared artificial insemination solution features single intratubal sperm delivery directed to the selected fallopian tube,

the natural site of conception, offering significant advantages over existing assisted reproductive approaches, including significant cost savings and reduction of safety risks.

Our first-line therapeutic infertility solution, FemaSeed, combines

with a diagnostic companion product, our FDA-cleared and marketed FemVue device, which, creates saline and air contrast to safely assess the fallopian tubes for patency prior to treatment with FemaSeed.

FemVue can be used with our FDA-cleared and

marketed FemCath device, which allows for selective evaluation of the fallopian tube.

At least one open fallopian tube is necessary for successful fertilization, and we believe FemVue offers significant advantages over other existing approaches,

including being able to provide ultrasound evaluation of a woman’s fallopian tubes as part of an existing diagnostic infertility assessment.

In April 2021 we received an IDE approval from the FDA that allowed us to initiate a pivotal trial for the

FemaSeed device.

The first subject was enrolled in July 2021.

In October 2022, we announced an updated study design for the pivotal trial to focus on couples experiencing male factor infertility, an underserved patient segment.

In April 2023 we

received approval to sell FemaSeed in Canada.

In September 2023 we announced 510(k) clearance from the FDA for FemaSeed for intratubal insemination.

The clinical trial was still ongoing at the time of receiving U.S.

regulatory clearance from FDA,

however, the study was concluded with enrollment completed in November 2023.

Topline results of the clinical trial were announced in March 2024.

The trial demonstrated that 24% of women became pregnant after FemaSeed with severe male factor (1

million to 20 million total motile sperm count (TMSC)).

In contrast, a 6.7% pregnancy rate by cycle was described in the literature for intrauterine insemination (IUI) with male factor (greater than 1 million TMSC).

Although permitted to have

multiple FemaSeed attempts, the majority of women who became pregnant did so after the first FemaSeed procedure.

The majority of adverse events were reported as mild (n=127 subjects, 216 cycles).

No new safety concerns were observed through the

seven-week follow-up.

All adverse events were consistent with those known for IUI.

The approved labeling includes women or couples wishing to become pregnant by way of intratubal insemination.

We began the first phase of commercial launch in March

2024 with the announcement of the first commercial use of FemaSeed.

FemVue, a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach

(hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S., Japan, and Canada.

FemChec allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success) and is being studied

as part of the FemBloc pivotal trial.

FemCath, allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter that is undirected, is approved for sale in the U.S and Canada.

an alternative for the diagnosis of cervical cancer by obtaining a comprehensive tissue sample with minimal contamination of the endocervical canal, and is approved for sale in the U.S and Canada.

In August 2023 the Company announced it had

obtained a Medical Device Establishment License from Health Canada allowing the Company to directly sell its four products, FemaSeed, FemVue, FemCath and FemCerv, in Canada.

In October 2023, the Company announced it had completed the European

Union Medical Device Regulation (MDR) final audit, the last step in obtaining an MDR certificate and CE marking, demonstrating Femasys’ compliance with the highest required regulatory standards.

FemBloc – Our Permanent Birth Control Solution .

Our permanent birth control solution in late-stage clinical development includes our proprietary FemBloc system, which features dual

intrauterine directional delivery targeting both fallopian tubes simultaneously with a degradable biopolymer followed by an ultrasound confirmation test to confirm procedure success.

If approved, we expect FemBloc to be the first and only

non-surgical permanent birth control option, using a minimally invasive delivery system that locally instills a degradable biopolymer, which is designed to cause the fallopian tubes to close using the patient’s own tissue in-growth, resulting in

permanent birth control (sterilization) for the patient without a permanent implant.

FemBloc has the potential to offer significant advantages over the only existing option, surgical tubal ligation, or “having her tubes tied,” including a

significant cost savings at likely half the overall cost.

FemBloc is a procedure that can be completed in a physician’s office, with no anesthesia, no incisions or cannulation, no specialty skill set or capital equipment and minimal pain and

recovery time, and no residual implant remaining in the patient’s body after the tissue in-growth develops.

We believe there are also significant advantages over other temporary or reversible methods that women may be using in lieu of the surgical

tubal ligation option, as FemBloc does not use hormones or leave a long-term implant behind.

Our permanent birth control solution combines FemBloc with an ultrasound in-office diagnostic test, which uses saline and air contrast to permit the same

physician to evaluate the fallopian tubes in-office to confirm the success of FemBloc approximately three months after the final FemBloc procedure, rather than requiring the patient to visit another provider for a radiology-based exam, exposing the

patient unnecessarily to radiation and the use of x-ray dye.

We have studied FemBloc in three prior clinical trials (a pilot safety study, a pivotal trial, and a validation study) pursuant to an FDA approved investigational device exemption (IDE) for each study with evaluation of

safety in a total of 228 subjects.

Subjects are being followed for five years for safety, and for the initial 49 subject pilot study, five years of follow-up have been completed.

There have been no serious safety events reported to date in any of

the subjects and over 90% of the events reported that were classified as related to the device, procedure or both, were on the day of the FemBloc procedure or within seven days after the procedure.

The reported events were anticipated and the

majority of these events were bleeding or spotting and/or pain or cramps and over 75% were classified by the physician as mild.

Physicians observed that their subjects found the procedure to be highly tolerable, with subject self-reported pain

scores similar to placement of IUDs.

Almost every case (96%) was assessed by the physician to be extremely satisfied or very satisfied with the procedure and 96% found it easier than tubal ligation surgery.

At the ultrasound confirmation test

conducted three months following the FemBloc procedure, there was no evidence of remaining biopolymer detected in subjects, which may indicate that the biopolymer completely degraded and likely exited the subject with possible menstruation.

Subjects found the FemBloc procedure and confirmation test to be highly tolerable, with pain or discomfort scores similar to placement of other intrauterine devices, such as IUDs.

The mean score for FemBloc procedure was 4.6 and for the

confirmation test was 3.3, on visual analog scale (VAS) from 0-10 where 10 is the highest measure of pain/ discomfort.

During the conduct of the first two clinical studies, unintended pregnancies occurred in subjects who were told to rely on FemBloc (six

pregnancies for the pilot study and three pregnancies for the pivotal trial).

These pregnancies were due to misinterpretation of the ultrasound test using the FemChec device, as reviewed and confirmed by an independent clinical events committee.

The FDA viewed these unintended pregnancies as a safety concern and, as a result, in February 2019 we paused the pivotal clinical trial for FemBloc (although subjects are still followed for safety through 5 years).

Subsequently, the agency

recommended conducting a small clinical study in a new cohort of subjects to evaluate the adequacy of certain proposed mitigations and validate the ultrasound confirmation test.

The study enrollment concluded in September 2022, in which 45

subjects at five U.S.

sites received two confirmation tests (ultrasound and traditional radiology).

Subjects were informed to rely on FemBloc only if both tests and two independent central readers confirmed procedure success.

There have been no

pregnancies in subjects accurately told to rely on FemBloc.

In June 2023 we received FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, in-office solution for permanent birth control in a

pivotal clinical trial.

In August 2023 we announced the initiation of enrollment in the FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] pivotal trial.

This prospective,

multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control.

In addition, the study is designed as a roll-in

beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects.

An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for permanent

birth control for one year.

Follow-up will continue annually for five years post-market.

Additional Women’s Health Solutions .

We have also developed a novel technology platform for tissue sampling intended to be marketed alongside our other women-specific medical

products in the physician’s office setting.

Our FDA-cleared and Health Canada approved FemCerv product is a biopsy device for endocervical curettage that can be used to sample cervical cells and tissue circumferentially with sample containment

within the device to minimize contamination.

We sponsored a post-market study of FemCerv where subjects found the procedure to be relatively pain-free and the sample obtained was complete for analysis, which we believe may aid in reliable

Our FemCerv product was introduced through a limited release in September 2022.

Our FemEMB product candidate in development is designed to obtain a comprehensive and uncontaminated sample of the endometrial cells and tissue in an office

We believe there is a market opportunity for use of FemEMB in continuous monitoring by multiple sampling procedures that may be employed by physicians during and after treatments for cancers, abnormal bleeding, or other uterine

treatments, such as prior to an endometrial ablation.

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

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

FemBloc® permanent birth control is a revolutionary first-of-its-kind non-surgical approach, 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 the safest most 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

Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.

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

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.

FemCath® and FemChec®, companion

diagnostic products for FemBloc’s ultrasound-based confirmation test, are U.S.

FDA-cleared and approved in Europe and Canada.

We are a woman-founded and led company with an expansive, internally created intellectual property portfolio with

approximately 200 issued patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop products with commercialization efforts underway.

Our suite of products and

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.

Factors Affecting Our Business

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These factors include:

Commencement and conduct of clinical trials for our product candidates .

We must successfully recruit and enroll clinical trial participants in our

clinical trial for FemBloc, which is further complicated by the after effects and public health concerns of the COVID-19 pandemic, in order to have the requisite data for regulatory submissions, both to the FDA and to international

regulatory bodies, for marketing authorization.

Regulatory approval of our product candidates .

We must successfully obtain timely approvals, de novo classifications or clearances for our product

For our sales to grow, we will need to receive FDA approval for the FemBloc system for permanent birth control, and will need to obtain regulatory approval, grant, clearance or marketing authorization of our other pipeline

products in the United States and in international markets.

Commencement and conduct of clinical trial for our product candidate .

We must successfully recruit and enroll clinical trial participants in our clinical

trial for FemBloc, in order to have the requisite data for regulatory submissions to the FDA for marketing authorization.

Regulatory approval of our product candidate .

We must successfully obtain timely approval for our product candidate.

For our sales to grow, we will need

to receive FDA approval for the FemBloc system for permanent birth control, and will need to obtain regulatory approval or marketing authorization of our product candidate in international markets.

Clinical results .

Publications of clinical results by us, our competitors and other third parties can have a significant influence on whether, and the

degree to which, our products are used by physicians and the procedures and treatments those physicians choose to provide.

degree to which, our products are used by healthcare practitioners and the procedures and treatments those healthcare practitioners choose to provide.

Commercialization and market acceptance .

The success of our business will ultimately depend on our ability to commercialize our approved products and

gain broad market acceptance of our products, which will require an extensive education process for both physicians and patients of the benefits of our products, engagement of a robust sales force infrastructure and increased manufacturing

gain broad market acceptance of our products, which will require an extensive education process for both healthcare practitioners and patients of the benefits of our products, development of a robust sales force infrastructure and increased

manufacturing capacity.

Competition .

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We must continue to successfully compete in light of our competitors’

existing and future products and related pricing and their resources to successfully market to the physicians who use our products.

existing and future products and related pricing and their resources to successfully market to the healthcare practitioners who use our products.

Our financial condition .

We need substantial additional funding to continue our development and commercialization plan and may be unable to raise capital

We must comply with covenants and payment obligations under our convertible notes.

While these factors may present significant opportunities for us, they also pose significant risks and challenges that we must address.

See the section titled “Risk Factors” for more information.

Impact of COVID-19 on Our Business

In March 2020, the World Health Organization declared the outbreak of COVID-19 caused by a novel strain of coronavirus as a pandemic.

This contagious disease outbreak continues to spread throughout the United States and

around the world, including through new variants of the virus that have been identified both inside and outside the United States.

The worldwide COVID-19 pandemic has affected and may continue to affect our ability to complete our current

preclinical studies and clinical trial, initiate and complete our planned preclinical studies and clinical trials, disrupt regulatory activities or have other adverse effects on our business, results of operations, financial condition and

In addition, the pandemic has caused substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could adversely affect our business, operations and ability to raise funds to support our

To date, we have experienced delays in site initiation and subject enrollment in our clinical trials and we may continue to experience some delays in our clinical trials and delays in data collection and analysis.

These delays so far

have had a severe impact, and the continued spread of COVID-19 globally could adversely impact our clinical trial operations further, including our ability to initiate sites, recruit and retain subjects and principal investigators and site staff

who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs in their geography.

The pandemic has decreased the number of elective surgical procedures, which, if sustained, could have an effect on our future

For example, tubal ligation procedures sustained an 18% decline in December 2020 compared to December 2019, according to a study published in the publication Contraception in 2021.

assurance that demand for elective reproductive surgery will return to pre-pandemic levels in the future, or at all.

We are continuing to monitor the potential impact of the pandemic, but we cannot be certain what the overall impact will be on our

business, financial condition, results of operations and prospects.

Components of Our Comprehensive Loss

Sales are primarily from the sale of our FemVue product.

We sell our product to physician offices, primarily through direct customer service, as well as through distributors in selected international markets.

Sales are primarily from the sale of our FemaSeed 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.

the year ended December 31, 2024, Comercial Medico Quiruigca, SA and Durgalab, distributors in Spain, accounted for approximately 15% and 12%, respectively, of our total revenue.

For the years ended December 31, 2024 and 2023, Bayer Yakuhin, Ltd.

accounted for approximately 7% and 5%, respectively, of our total revenue.

For products sold 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.

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.

Cost of sales

Cost of sales consists primarily of costs of components for use in our product, the materials and labor that are used to produce our products, and the manufacturing overhead that directly supports production.

Cost of sales consists primarily of costs of components for use in our products, the materials and labor that are used to produce our products, and the manufacturing overhead that directly supports production.

cost of sales to increase in absolute terms as our revenue grows.

Research and development

Research and development, or R&D, expenses consist of engineering, product development, clinical, and regulatory expenses.

Research and development, or R&D, expenses consist of engineering, product development, clinical, quality assurance and regulatory expenses.

R&D expenses include:

cost of clinical trials to support our product candidates and product enhancements, including expenses for activities conducted by third-party services providers, primarily clinical research organizations, or

CROs, and site payments;

cost of clinical trials to support our product candidate FemBloc and product enhancements, including expenses for activities conducted by third-party services providers, primarily clinical research organizations,

or CROs, and site payments;

certain personnel-related expenses, including salaries, benefits and stock-based compensation;

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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 product candidates, expand our product candidate pipeline, enhance our

In the future, we expect R&D expenses to increase in absolute dollars as we continue to develop our product candidate FemBloc, expand our product candidate pipeline, enhance our

existing products and technologies and perform activities related to obtaining additional regulatory approval.

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including travel, trade shows and market research, and cost of outside consultants.

We expect to grow a sales force and increase marketing efforts as we commercialize our products based on our platform technologies.

As a result, we expect sales and

marketing expenses to increase in absolute dollars in future periods.

We expect to expand our sales force and increase our marketing efforts as we commercialize our products based on our platform technologies.

As a result, we expect

sales and marketing expenses to increase in absolute dollars in future periods.

General and administrative

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Depreciation and amortization

Depreciation and amortization expenses consist of depreciation expense associated with our fixed assets and lease right of-use assets and amortization expense associated with our patents.

We expect to invest in capital

equipment to support our ongoing and planned commercialization efforts and continue to invest in our intellectual property.

Depreciation and amortization expenses consist of depreciation expense associated with our fixed assets and amortization associated with our lease right-of-use assets and patents.

We expect to invest in capital equipment

to support our ongoing and planned commercialization efforts and continue to invest in our intellectual property.

As a result, we expect our depreciation and amortization expenses to increase in absolute dollars in the future.

Other income (expense)

Other income (expense) consists largely of interest earned on our cash equivalents and short-term investments, offset by interest expense and other expenses.

Other (expense) income

Other (expense) income consists largely of interest earned on our cash equivalents and short-term investments, offset by interest expense and other expenses.

Income tax expense

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Loss from operations

Other income (expense):

Other (expense) income:

Interest income

Interest expense

Other expense

Other income (expense), net

Total other (expense) income

Loss before income taxes

Income tax expense

Sales from FemVue decreased by $134,248 or 11.1%, to $1,071,970 in 2023 from $1,206,218 in 2022.

The decrease is attributable to reduced U.S.

and international sales of $76,434 and $57,814, respectively for the comparable

sales decreased by 7.0% in 2023 as compared to 2022, represented by a 9.0% decrease in units sold, offset by a slightly increased average selling price.

International sales decreased by 49.9% in 2023 compared to 2022, represented by a

50.1% decrease in units sold, offset by a 0.4% increase in the average selling price.

Sales increased by $557,138 or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023.

The increase is attributable primarily to FemaSeed product sales of $509,650, which was commercialized in 2024.

FemVue units sold

increased by 6.9% in 2024 as compared to 2023, while maintaining a relatively flat average selling price.

Cost of sales

Cost of sales decreased by $61,869, or 14.0%, to $380,069 in 2023 from $441,938 in 2022.

The decrease in cost of sales is primarily attributed to reduced sales and certain manufacturing efficiencies.

Cost of sales increased by $164,834, or 43.4%, to $544,903 in 2024 from $380,069 in 2023.

The increase in cost of sales is primarily attributed to increased sales, partially offset by certain manufacturing efficiencies.

Research and development

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R&D expenses increased by $1,007,842 or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023.

The increase of $1,394,946 is primarily due to increased compensation costs, material and development costs, and

professional and outside consultant costs, partially offset by reduced clinical-related costs and other costs.

The increase is primarily due to increased compensation costs, material and development costs, and professional and outside

consultant costs.

Sales and marketing

Sales and marketing expenses increased by $3,380,024 or 519.9%, to $4,030,150 in 2024 from $650,126 in 2023.

The net increase relates primarily to marketing and travel costs to promote our commercial products.

The increase relates primarily to compensation, marketing and travel costs as we recruited a commercial team to

promote our available products.

General and administrative

General and administrative expenses increased by $1,427,304, or 26.3%, to $6,858,008 in 2023 from $5,430,704 in 2022.

The increase relates primarily to increased compensation costs, share-based compensation expense and

professional costs, partially offset by decreased facility and other overhead costs.

General and administrative expenses decreased by $532,009, or 7.8%, to $6,325,999 in 2024 from $6,858,008 in 2023.

The decrease relates primarily to decreased compensation expense and professional costs, partially offset

by increased facility and other overhead costs.

Depreciation and amortization

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expense associated with the Company’s intangible assets that have reached the end of their useful lives.

Other income (expense)

Total other income (expense) increased by $53,235, or 25.1%, to $265,629 in 2023 from $212,394 in 2022.

The increase relates to interest income, partially offset by interest expense and non-cash discount amortization

related to the convertible notes payable.

Other (expense) income

Total other (expense) income decreased by $1,286,850, or 484.5%, to $1,021,221 net expense in 2024 from $265,629 net income in 2023.

relates to increased interest expense and non-cash discount amortization related to the convertible notes payable which were outstanding for the full year, partially offset by increased interest income.

Income tax expense

Income tax expense decreased by $1,962 or 31.1%, to $4,338 in 2023 from $6,300 in 2022 due to a decrease in the minimum net worth taxes we are required to pay.

Income tax expense increased by $5,264 or 121.3%, to $9,602 in 2024 from $4,338 in 2023 due to an increase in the state minimum taxes we are required to pay.

Liquidity and Capital Resources

Sources of liquidity

Since our inception through December 31, 2023, 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

As of December 31, 2023, we had $21,716,077 of cash and cash equivalents and an accumulated deficit of $108,381,629.

Since our inception through December 31, 2024, our operations have been financed primarily by net proceeds from the sale of our common stock and convertible indebtedness and, to a lesser extent, product revenue.

December 31, 2024, we had $3,451,761 of cash and cash equivalents and an accumulated deficit of $127,198,257.

In July 2022, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co.

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“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 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.

As of December 31, 2023, approximately 3.3 million shares of common stock have been sold for aggregate proceeds of $7.7 million under the Equity Distribution Agreement pursuant to the prospectus.

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 sold 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 4.6 million shares of common stock have been sold to date for aggregate proceeds of $9.8 million under the Equity Distribution Agreement pursuant to the

Subsequent to December 31, 2024, we raised approximately $5.4 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 April 2023, we sold an aggregate of (i) 1,318,000 shares of common stock and (ii) pre-funded warrants to purchase up to 1,878,722 shares of common stock in a registered direct offering and, in a concurrent private

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The warrants in the

April 2023 Financing were fully exercised for cash for additional proceeds of $3.5 million.

April 2023 Financing were fully exercised for additional cash proceeds of $3.5 million during 2023.

Placement agent warrants of 122,994 were exercised for additional cash proceeds of $0.2 million during 2023.

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,

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Net proceeds from the November 2023 Financing were $6.3 million.

If exercised for cash, the

warrants issued in the November 2023 Financing could result in proceeds of up to an additional $15.4 million.

The Series B Warrants expired

in November 2024 unexercised.

If exercised for cash, the Series A Warrants issued in the November 2023 Financing could result in proceeds of up to an additional $6.8 million.

The Series A Warrants expire in November 2028.

In February 2025, $85,000

of Series A Convertible Notes were converted into 72,033 shares of common stock.

Funding requirements

Based on our current operating plan, our current cash and cash equivalents are expected to be sufficient to fund our ongoing operations into the second half of 2025.

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.

Our cash and cash equivalents as of December 31, 2023 will not be sufficient to fund all of our product candidates through regulatory approval, and we anticipate needing to raise additional capital to complete the

development and commercialization of our product candidates.

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.

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, and anticipated revenues from product sales are expected to be

sufficient to fund our ongoing operations into the third quarter of 2025.

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.

Our cash and cash equivalents as of December 31, 2024, revenues from product sales and approximately $5.4 million we raised subsequent to year end, will not be sufficient to sustain our operations, including funding our

product candidate, FemBloc, through regulatory approval, and we will need to raise additional capital to complete the development and 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 product candidates, or we may need to obtain funds through collaborations or otherwise on terms that may require us to relinquish rights to our technologies or product candidates that we might

significantly modify, or delay the development of our 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 product candidate that we might

otherwise seek to develop or commercialize independently.

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experience a complete loss of your investment.

We expect to continue to make substantial investments in our ongoing trials and in additional clinical trials that are designed to provide clinical evidence of the safety and effectiveness of our products.

We also expect

to continue to make investments in research and development, manufacturing, regulatory affairs and clinical trials to develop future products.

If our product candidates are approved, we will need to make investments in our sales and marketing

organization.

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 product candidate, FemBloc.

We also expect to

continue to make investments in research and development to develop future products, manufacturing, regulatory affairs and post-market clinical trials.

We will additionally need to make investments in our sales and marketing organization for

FemaSeed, and 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.

Our future capital requirements will depend on many factors, including:

the cost, timing and results of our clinical trials and regulatory reviews;

the cost, timing and results of our clinical trial and regulatory reviews;

the cost and timing of establishing sales, marketing and distribution capabilities;

the timing, receipt and amount of sales from our current and potential products;

our ability to continue manufacturing our products and product candidates and to secure the components, services and supplies needed in their production;

our ability to continue manufacturing our products and product candidate and to secure the components, services and supplies needed in their production;

the degree of success we experience in commercializing our products;

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Net cash used in investing activities

Net cash provided by (used in) financing activities

Net cash provided by financing activities

Net change in cash and cash equivalents

Operating activities

In 2023, cash used in operating activities was $11,280,546, attributable to a net loss of $14,247,124, offset by non-cash charges of $1,745,072 and a net change in our net operating assets and liabilities of $1,221,506.

Non-cash charges primarily consisted of $675,700 in stock-based compensation, $907,985 in depreciation and amortization and $107,963 in amortization of the discount on the convertible notes.

The change in our net operating assets and liabilities

was primarily due to an increase of $1,614,647 in accounts payable and accrued liabilities, partially offset by and a decrease of $440,489 in lease liabilities.

In 2022, cash used in operating activities was $10,731,973, attributable to a net loss of $11,394,170 and a net change in our net operating assets and liabilities of $458,267, offset by non-cash charges of $1,120,464.

Non-cash charges primarily consisted of $224,939 in stock-based compensation and $889,140 in depreciation and amortization.

The change in our net operating assets and liabilities was primarily due to an increase of $232,553 in inventory and a

decrease of $383,616 in lease liabilities, offset by a change in prepaid and other assets of $295,862.

In 2024, cash used in operating activities was $19,444,009, attributable to a net loss of $18,816,628, a net change in our net operating assets and liabilities of $3,144,778, partially offset by non-cash charges of

Non-cash charges primarily consisted of $1,192,574 in amortization of the discount on the convertible 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 increases of $2,379,205 in inventory, $397,467 in accounts receivable, $139,136 in prepaid and other assets, a decrease of $406,636 in lease liabilities, partially offset by an increase of $207,481 in

accounts payable.

The Company intends to meet future operating cash requirements through increased sales of commercial products and fundraising, as discussed in Funding requirements.

In 2023, cash used in operating activities was $11,280,546, attributable to a net loss of $14,247,124, offset by non-cash charges of $1,739,186 and a

net change in our net operating assets and liabilities of $1,227,392.

Non-cash charges primarily consisted of $675,700 in stock-based compensation, $907,985 in depreciation and amortization and $107,963 in amortization of the discount on the

convertible notes.

The change in our net operating assets and liabilities was primarily due to an increase of $1,614,647 in accounts payable and accrued liabilities, partially offset by a decrease of $440,489 in lease liabilities.

Investing activities

In 2023, cash used in investing activities for the purchase of equipment was $143,917.

In 2022, cash used in investing activities for the purchase of equipment was $407,475.

In 2024, cash used in investing activities for the purchases of fixed assets and intangible assets was $761,706 and $86,058, respectively.

In 2023, cash used in investing activities for the purchase of fixed assets was

Financing activities

In 2024, cash provided by financing activities was $2,027,457, attributable to sales under the at-the-market facility of $2,025,104 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.

In 2023, cash provided by financing activities was $20,178,604, attributable primarily to cash provided by proceeds from the issuance of stock and subsequent warrant exercises of $7,587,977, sales under the at-the-market

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facility of $229,953 and payments under lease obligations of $16,193.

In 2022, cash used in financing activities was $681,645, attributable to payments of deferred offering costs of $232,845, repayments on notes payable of $505,205 and payments under lease obligations of $23,058, partially

offset by proceeds from issuance of common stock of $79,463.

Off-Balance Sheet Arrangements

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While our significant accounting policies are more fully described in Note 2 to our financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following discussion addresses our most

critical accounting policies, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.

critical accounting policy, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.

Revenue recognition

Our policy is to recognize revenue when a customer obtains control of the promised goods under Accounting Standards 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.

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 point in time and no revenue is recognized over time.

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 ranging from 30 to 60 days.

All revenue is recognized point in time.

The majority of products sold directly to U.S.

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As of December 31, 2024, we have not had a history of significant returns.

Accrued expenses

We accrue expenses for estimated costs of R&D activities conducted by our third-party service providers, which include the conduct of preclinical studies and clinical trials.

We record the estimated costs of

R&D activities based upon the estimated amount of services provided but not yet invoiced.

These costs, at times, may be a significant component of the research and development expenses and the Company makes estimates in determining the accrued

expense each period.

As actual costs become known, the Company adjusts its accrual.

These accrued R&D costs are included in accrued expenses on the balance sheet and within R&D expense on the statement of comprehensive loss.

Recent Accounting Pronouncements

See Notes 2(ab) and 2(ac) to our financial statements in Part II, Item 8 for information related to recently issued accounting pronouncements.

See Notes 2(aa) and 2(ab) to our financial statements in Part II, Item 8 for information related to recently issued accounting pronouncements.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis