-- Femasys continues to expand access and market share for its first-line infertility treatment option, FemaSeed® -- ATLANTA, June 11, 2025 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products announces a partnership with Carolinas Fertility Institute (CFI), one of America’s best fertility clinics. Carolinas Fertility Ins ...

ATLANTA, May 30, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY) (the “Company” or “Femasys”), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, today announced the pricing of an underwritten public offering of 3,600,000 shares of its common stock at a public offering price of $0.85 per share and a separate concurrent private placement of 1,686,275 shares of its ...

ATLANTA, May 29, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY) (the “Company” or “Femasys”), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. In addition, Femasys expects to grant the underwriters a 30-day option to purchase up to an additional 15% ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission file number: 001-40492. Femasys Inc. (Exact Name of Registrant as Specified in its Charter) 3950 Johns Creek Court, Suite 100 ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to_______ ...

Exhibit 99.1 Femasys Announces Financial Results for Quarter Ended March 31, 2025, and Provides Corporate Update -- Company delivers on mission to transform women's health with innovative solutions, including FemaSeed® for first-line infertility treatment and FemBloc® non-surgical permanent birth control (full system approval pending in Europe) -- ATLANTA, May 8, 2025 -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad p ...

-- Company delivers on mission to transform women’s health with innovative solutions, including FemaSeed® for first-line infertility treatment and FemBloc® non-surgical permanent birth control (full system approval pending in Europe) -- ATLANTA, May 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces fi ...

Femasys Inc. (FEMY) came out with a quarterly loss of $0.23 per share versus the Zacks Consensus Estimate of a loss of $0.25. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8%. A quarter ago, it was expected that this company would post a loss of $0.20 per share when it actually produced a loss of $0.24, delivering a surprise of -20%.Over the last four quarters, the company has surpassed consens ...

Financial Performance - Total assets decreased from $27,755,825 in 2023 to $12,445,002 in 2024, representing a decline of approximately 55.1%[463] - Cash and cash equivalents dropped significantly from $21,716,077 in 2023 to $3,451,761 in 2024, a decrease of about 84.1%[463] - The company reported a net accumulated deficit of $127,198,257 as of December 31, 2024, up from $108,381,629 in 2023, indicating an increase in losses[465] - Sales for the year ended December 31, 2024, reached $1,629,108, an increase of 51.9% compared to $1,071,970 in 2023[467] - Net loss for 2024 was $18,816,628, compared to a net loss of $14,247,124 in 2023, representing a 32.5% increase in losses[467] - Total revenue for the year ended December 31, 2024, was $1,629,108, a significant increase from $1,071,970 in 2023, representing a growth of approximately 52%[509] - U.S. revenue for 2024 was $1,073,508, up from $1,013,925 in 2023, while international revenue surged to $555,600 from $58,045[509] Operating Expenses - Total operating expenses increased to $18,870,010 in 2024, up 24.1% from $15,200,316 in 2023[467] - Research and development expenses rose to $8,216,543 in 2024, up 14.0% from $7,208,701 in 2023[467] - Sales and marketing expenses surged to $4,030,150 in 2024, a significant increase from $650,126 in 2023[467] - Interest expense rose significantly to $(1,603,575) in 2024 from $(165,390) in 2023, indicating a substantial increase in borrowing costs[467] - The company incurred depreciation expenses of $277,178 in 2024, a decrease from $480,187 in 2023[473] - The company’s operating lease cost for the year ending December 31, 2024, was $619,796, an increase from $469,995 in 2023[533] Cash Flow and Liquidity - Net cash used in operating activities for 2024 was $19,444,009, compared to $11,280,546 in 2023, indicating a significant increase in cash outflow[473] - The company has a substantial reliance on the FDA's approval for its FemBloc system, which is currently in late-stage development[18] - The company plans to finance operations through existing cash, additional equity, and anticipated revenue from product sales, primarily focusing on FemaSeed and FemVue[478] - The company faces substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows[457] Debt and Financing - The company’s convertible notes mature in November 2025, raising concerns about future funding[457] - The Company recognized total interest expense on the convertible notes of $1,603,575 for the year ended December 31, 2024, including coupon interest expense of $411,001 and amortization of debt discount of $1,192,574[547] - The Company issued senior unsecured convertible notes totaling $6,850,000 on November 21, 2023, convertible at a price of $1.18 per share[540] - The effective interest rate for the discount amortization of the convertible notes was 32.3%[547] - As of December 31, 2024, the fair value of the convertible notes was $6,493,720, calculated using a discounted cash flow analysis[547] Regulatory and Market Position - The company has received global regulatory approvals for its product portfolio, including FemaSeed, FemVue, and FemBloc, with ongoing commercialization efforts[476] - The pivotal clinical trial for FemBloc is currently enrolling participants for U.S. approval, with CE mark certification expected in mid-2025[476] - The company has limited experience in marketing and selling its women-specific medical product solutions[24] - The company plans to rely on distribution partners outside of North America to market its women-specific medical products[22] Stock and Equity - The company sold approximately 1.3 million shares of common stock for aggregate proceeds of $2 million during the year ended December 31, 2024[559] - The company completed an April 2023 financing that resulted in gross proceeds of $3,899,813, after deducting $547,764 in transaction costs[560] - The company is authorized to sell up to $150 million in common and preferred stock, debt securities, and warrants under a shelf registration statement filed in July 2022[559] - As of December 31, 2024, the total stock-based compensation expense recognized was $444,147, a decrease from $675,700 in 2023[598] Tax and Valuation - As of December 31, 2024, the company has federal net operating loss carryforwards of $104,880,492, an increase from $90,380,015 in 2023[553] - The company recorded a valuation allowance change of $4,776,250 for the year ended December 31, 2024, compared to $3,397,568 for 2023[550] - The company has federal research and experimentation tax credits of $3,723,817 as of December 31, 2024, up from $3,231,910 in 2023[553] - The effective tax rate for the company is influenced by a valuation allowance of $(26.00)% in 2024 and $(24.00)% in 2023[550] Employee Compensation and Stock Options - The company contributed $97,876 and $75,202 in voluntary employer matching contributions to its 401(k) plan for the years ended December 31, 2024 and 2023, respectively[600] - As of December 31, 2024, 84,621 shares of common stock have been purchased under the Employee Stock Purchase Plan (ESPP), with 535,356 shares reserved for future awards[596] - The total number of shares of common stock available for awards under the 2021 Equity Incentive Plan is 1,111,111, with automatic increases based on outstanding shares[579] - As of December 31, 2024, the company had 2,974,219 stock options outstanding, with a weighted average exercise price of $1.60[582]

Financial Performance - Sales increased by $557,138, or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023[7] - Net loss was $18,816,628, or ($0.85) per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $14,247,124, or ($0.93) per share for 2023[7] - Total current liabilities increased to $8,582,869 in 2024 from $3,054,055 in 2023[11] - Total assets decreased to $12,445,002 in 2024 from $27,755,825 in 2023[11] Research and Development - Research and development expenses increased by $1,007,842, or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023[7] Cash Position - Cash and cash equivalents as of December 31, 2024, was $3.5 million, with an accumulated deficit of $127.2 million[7] - The company expects current cash and equivalents to fund operations into Q3 2025[3] Revenue Expectations - U.S. revenue for FemaSeed is expected to increase by approximately 50% in Q1 2025 versus Q4 2024[3] Product Development and Partnerships - FemBloc® permanent birth control received approval in Europe, with CE mark approval pending[4] - Strategic partnerships announced for FemaSeed with CNY Fertility and HRC Fertility[4]

Core Insights - Femasys Inc. has achieved significant regulatory and commercial milestones for its FemBloc and FemaSeed products, with expectations of a 50% increase in U.S. revenue for FemaSeed in Q1 2025 compared to Q4 2024 [3] - The company has received approval for FemBloc in Europe and is advancing its clinical trial for U.S. FDA approval, indicating a strong commitment to addressing women's reproductive health needs [3][6] - Financial results for 2024 show a sales increase of 52% to $1.63 million, while net loss increased to $18.82 million, reflecting ongoing investment in research and development [7][11] Company Developments - Femasys announced partnerships for the distribution of FemBloc in Spain and with CNY Fertility for FemaSeed, expanding its market reach [6] - The company has received regulatory approvals for FemaSeed in the UK and Israel, and has published positive clinical trial results for both FemBloc and FemaSeed [6][12] - The FemBloc delivery system is noted as the first non-surgical, in-office permanent birth control method, with expected CE mark approval pending [13] Financial Performance - Sales increased by $557,138, or 52%, from $1.07 million in 2023 to $1.63 million in 2024 [7] - Research and development expenses rose by $1.01 million, or 14%, to $8.22 million in 2024 [7] - As of December 31, 2024, cash and cash equivalents were $3.5 million, with an accumulated deficit of $127.2 million, but the company expects sufficient funds to operate into Q3 2025 [7][9]