FEMASYS INC

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K 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. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Annual Report on Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning:

• our ability to obtain additional financing to fund commercialization of our products and fund our operations;

• our ability to obtain additional financing to fund the U.S. clinical development of our U.S. product candidate FemBloc® permanent birth control;

• our ability to obtain U.S. Food and Drug Administration (FDA) approval for our U.S. product candidate, FemBloc, for permanent birth control;

• our ability to successfully grow sales of FemaSeed® intratubal insemination in the U.S.;

• our ability to successfully grow sales internationally;

• estimates regarding the total addressable market for our products and U.S. product candidate;

• competitive companies and technologies in our industry;

• our business model and strategic plans for our products, U.S. product candidate, technologies and business, including our implementation thereof;

• commercial success and market acceptance of our products and U.S. product candidate;

• our ability to achieve and maintain adequate levels of coverage or reimbursement for FemBloc or any future product candidates, and our products we seek to commercialize;

• our ability to accurately forecast customer demand for our products and U.S. product candidate, and manage our inventory;

• our ability to build, manage and maintain our direct sales and marketing organization, and to market and sell our FemaSeed intratubal insemination product, FemBloc permanent birth control system, and women-specific medical product solutions in markets in and outside of the United States;

• our ability to establish, maintain, grow or increase sales and revenues;

• our expectations about market trends;

• our ability to continue operating as a going concern;

• the ability of our clinical trials to demonstrate safety and effectiveness of our U.S. product candidate, FemBloc, and other positive results;

• our ability to enroll subjects in the clinical trial for our U.S. product candidate, FemBloc, in order to advance the development thereof on a timely basis;

• our ability to manufacture our products and U.S. product candidate, if approved, in compliance with applicable laws, regulations and requirements and to oversee third-party suppliers, service providers and vendors in the performance of any contracted activities in accordance with applicable laws, regulations and requirements;

• our ability to hire and retain our senior management and other highly qualified personnel;

• FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets;

• the timing or likelihood of regulatory filings and approvals or clearances;

• our ability to establish and maintain intellectual property protection for our products and U.S. product candidate and our ability to avoid claims of infringement; and

The forward-looking statements in this Annual Report on Form 10-K are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Annual Report on Form 10-K and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the sections in this Annual Report on Form 10-K entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Annual Report on Form 10-K. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. You should read this Annual Report on Form 10-K and the documents that we reference in this Annual Report on Form 10-K and have filed with the U.S. Securities and Exchange Commission (SEC) as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

The following is a summary of the principal risk factors associated with an investment in our common stock.

• We have incurred significant operating losses since inception, and we expect to incur operating losses in the future.

• We need substantial additional funding and may be unable to raise equity capital or debt financing when needed.

• Our financial results may fluctuate significantly.

• Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income, if any, may be subject to certain limitations.

• 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.

Risks Related to Discovery and Development

• Enrollment and retention of subjects in clinical trials is an expensive and time-consuming process.

• Our current U.S. product candidate is in late-stage development.

• We are substantially dependent on the FDA’s permission to market our FemBloc system.

• The clinical development process required to obtain regulatory approvals is lengthy and expensive with uncertain outcomes.

• Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available.

• Our products may fail to gain increased market acceptance.

• Our FemaSeed intratubal insemination solution may fail to gain market acceptance.

• If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our FemBloc permanent birth control solution, our commercial success may be severely hindered.

• Third-party payors and healthcare practitioners who do not cover or use our permanent birth control solution or other women’s healthcare devices may require additional clinical data prior to adopting or maintaining coverage of our FemBloc system.

• The training required for healthcare practitioners to use our FemBloc permanent birth control solution could reduce the market acceptance of our U.S. product candidate.

• Some of our competitors have longer operating histories and more established products or greater resources than we do.

• Our long-term growth depends on our ability to enhance our solutions, expand our indications and develop and commercialize additional products.

• Our results of operations could be materially harmed if we are unable to accurately forecast customer demand and manage our inventory.

• We manufacture and assemble components for our products and U.S. product candidate, and a loss or degradation in performance of our manufacturing capabilities could have a material adverse effect on our business.

• We rely on a limited number of third-party suppliers for components for our products and U.S. product candidate.

• Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business.

• We have limited experience marketing and selling our women-specific medical product solutions.

• We plan to rely on our own direct sales force in North America to market our women-specific medical products.

• We plan to rely on distribution partners outside of North America to market our women-specific medical products.

• We face the risk of product liability claims that could be expensive.

• If the quality of our solutions does not meet the expectations of healthcare practitioners or patients, then our brand and reputation or our business could be adversely affected.

• We face risks related to health epidemics and outbreaks.

• Failure of a key information technology system, process or site could have an adverse effect on our business.

• Our facilities could become damaged or inoperable.

• Our ability to maintain our competitive position depends on our ability to attract and retain highly qualified talent.

Risks Related to Government Regulation

• Our products and operations are subject to extensive government regulations.

• We may not receive the necessary regulatory approvals, classifications, or clearances to grow our business.

• Modifications to our U.S. product candidate if FDA approved may require us to obtain new Premarket Approval (PMA) approval or approvals of a PMA supplement.

• Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions.

• Our products must be manufactured in accordance with federal and state regulations.

• If treatment guidelines for permanent birth control or other women’s healthcare treatments change or the standard of care evolves, we may need to redesign and seek new marketing authorization from the FDA for one or more of our products.

• There may be misuse or off-label use of our products in the marketplace.

• Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions.

• If we do not obtain and maintain international regulatory registrations or approvals for our products, we will be unable to market and sell our products outside of the United States.

• Legislative or regulatory reforms in the United States or the European Union may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products.

• Our business involves the use of hazardous materials.

Risks Related to Intellectual Property Matters

• If we are unable to adequately protect our intellectual property rights, our competitive position could be harmed.

• Obtaining and maintaining patent protection depends on compliance with various governmental requirements.

• Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money.

• Recent changes in U.S. patent laws could diminish the value of patents in general.

• Patent terms may be inadequate to protect our competitive position on our products.

Risks Related to Our Common Stock

• Our directors, officers and principal stockholders have significant voting power.

• We incur significant costs as a result of being a public company.

• We are obligated to develop and maintain proper and effective internal controls over financial reporting.