Core Insights - Femasys Inc. has received approval from New Zealand's MEDSAFE for its FemBloc Permanent Birth Control, marking a significant step in the company's global expansion strategy [1][2] - The approval follows recent CE Mark and UK approvals, indicating growing regulatory confidence in Femasys' technology [2] - FemBloc is a non-surgical solution for permanent birth control, utilizing a patented delivery system that creates natural scar tissue for permanent occlusion, offering a safer and more cost-effective alternative to surgical sterilization [3][5] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company's fertility portfolio includes FemaSeed Intratubal Insemination and FemVue, a companion diagnostic for fallopian tube assessment, with FemaSeed showing over twice the effectiveness of traditional IUI [4] Market Context - New Zealand is identified as a strategically important healthcare market in the Asia-Pacific region, emphasizing women's health and equitable access to innovative treatments [2] - The approval of FemBloc not only validates its safety and effectiveness but also positions Femasys to provide women in New Zealand with access to a groundbreaking non-surgical permanent birth control option [2]

Core Insights - Femasys Inc. has successfully closed $8 million in financing to enhance its commercialization efforts and address unmet needs in women's reproductive health [1][2] - The company focuses on making fertility treatments and non-surgical permanent birth control more accessible and cost-effective for women globally [3] Company Overview - Femasys is a biomedical innovator with a patent-protected portfolio of therapeutic and diagnostic products aimed at women's health [3] - The company's lead products include FemaSeed, an intratubal insemination treatment, and FemBloc, a non-surgical permanent birth control option [3][4] Recent Milestones - Regulatory approvals for FemBloc were obtained in Europe on June 25, 2025, and in the United Kingdom on August 20, 2025 [6] - FemaSeed received regulatory approval in Australia and New Zealand on July 1, 2025 [6] - The company made its first commercial entry into Europe with a $400,000 order for FemBloc in Spain on August 6, 2025 [6] - A partnership was established with Carolinas Fertility Institute to offer FemaSeed across eight locations [6] Leadership Commentary - CEO Kathy Lee-Sepsick emphasized the importance of the new financing in executing the company's strategy and achieving revenue growth [2] - Jorey Chernett, a major shareholder, highlighted the critical need addressed by FemBloc and expressed confidence in Femasys' mission and products [2]

Group 1 - The core point of the article is that Femasys (FEMY.US) experienced a significant stock price drop of 37%, reaching a new low for the year at $0.32 [1] - The company announced a public offering to raise $8 million, which will be used to support its business expansion and product development plans [1]

Core Viewpoint - Femasys Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $8.0 million to support its commercial expansion and product development efforts [2][4]. Group 1: Offering Details - The public offering consists of 10,434,586 shares of common stock and pre-funded warrants to purchase up to 11,750,000 shares, with a combined offering price of $0.36 per share and accompanying common warrant [1][2]. - The offering is expected to close on or about August 27, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - Femasys plans to utilize the net proceeds from the offering for the expansion of commercial efforts, product development, general corporate purposes, capital expenditures, and working capital [2]. Group 3: Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of in-office therapeutic and diagnostic products [6]. - The company’s fertility portfolio includes FemaSeed, which is over twice as effective as traditional IUI, and FemVue, a diagnostic tool for fallopian tube assessment [6]. - FemBloc, a non-surgical permanent birth control method, received regulatory approval in Europe and the UK in 2025, with commercialization planned through strategic partnerships [7].

Core Insights - Femasys Inc. has launched the FemSperm Setup Kit, the first product in a new line aimed at enabling gynecologists to offer FemaSeed Intratubal Insemination, thereby expanding access to fertility treatments and driving revenue growth [1][2] - The FemSperm Setup Kit includes a pre-configured centrifuge for optimal sperm preparation, facilitating a streamlined in-office solution for gynecologists [1][2] - FemaSeed is positioned as a first-step fertility treatment that enhances natural fertilization by delivering sperm directly to the fallopian tube, showing more than double the pregnancy rates compared to traditional intrauterine insemination (IUI) in cases of low male sperm count [2][3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [3] - The company is actively commercializing its lead product innovations, including FemaSeed and FemVue, in the U.S. and key international markets [3] - Femasys' FemBloc product, a non-surgical permanent birth control solution, received regulatory approval in Europe and the UK in mid-2025, with commercialization planned through strategic partnerships [4]

Core Insights - Femasys Inc. has received MHRA approval for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy [1][2] - The approval follows the CE mark received earlier and positions Femasys to secure strategic partnerships for commercialization in the UK [2] - FemBloc is a non-surgical solution for permanent birth control, utilizing a patented delivery system to create natural scar tissue for occlusion, thus avoiding the risks associated with surgical sterilization [3][5] Company Overview - Femasys is focused on making fertility and non-surgical permanent birth control more accessible and cost-effective through a patent-protected portfolio of products [4] - The company is actively commercializing its innovations in the U.S. and key international markets, with a fertility portfolio that includes FemaSeed and FemVue [4] - FemBloc is the first non-surgical, in-office alternative to surgical sterilization, with plans for commercialization through strategic partnerships in select European countries [5] Market Context - The UK is one of the largest healthcare markets in Europe, emphasizing women's health solutions, which provides a favorable environment for innovative technologies like FemBloc [2] - The single-payer NHS system in the UK facilitates the adoption of technologies that improve access and reduce costs [2] - FemBloc's approval validates its safety and effectiveness, allowing Femasys to cater to a diverse patient population in this critical market [2]

Core Insights - Femasys reported strong revenue growth of 84.8% year-over-year, reaching $0.41 million in Q2 2025, driven by sales of FemaSeed and FemVue products [1][5] - The company achieved a GAAP net loss of $4.59 million, a slight improvement from the previous year's loss of $4.68 million [1][8] - Femasys has a cash balance of $3.22 million as of June 30, 2025, indicating a need for additional funding to sustain operations [1][10] Financial Performance - Revenue (GAAP) for Q2 2025 was $0.41 million, significantly above analyst estimates of $1.02 million [2] - Diluted earnings per share (GAAP) improved to $(0.16), better than the previous year's $(0.21) [2] - Research and Development expenses decreased by 28.6% to $1.41 million compared to $1.98 million in Q2 2024 [2][8] Product and Market Development - Femasys focuses on non-surgical products for women's reproductive health, including the FemBloc system for permanent birth control and fertility solutions like FemaSeed and FemVue [3][4] - The company made significant regulatory progress, receiving its first European approval for FemBloc and gaining approvals for FemaSeed and FemVue in Australia and New Zealand [6][7] - A notable order from Spain indicates a pivotal step in Femasys's international expansion efforts [5] Strategic Partnerships and Intellectual Property - Femasys formed a partnership with the Carolinas Fertility Institute to expand the reach of FemaSeed [7] - The company is actively working on protecting its intellectual property, with new patents expected to be granted in Europe and the U.S. for FemBloc and FemaSeed [7] Future Outlook - Management did not provide specific revenue or earnings targets for the upcoming quarters but emphasized the importance of translating recent approvals into commercial adoption [9] - The company expects its current cash position to fund operations into early Q4 2025, highlighting the need for monitoring its international expansion and product pipeline [10]

[FORM 10-Q General Information](index=1&type=section&id=FORM%2010-Q%20General%20Information) Femasys Inc. filed its Q2 2025 Form 10-Q, listed on Nasdaq, and is classified as an emerging growth and smaller reporting company - Femasys Inc. filed its Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) - The company's common stock (FEMY) is registered on The Nasdaq Capital Market[3](index=3&type=chunk) - Femasys Inc. is classified as an emerging growth company and a smaller reporting company[3](index=3&type=chunk)[4](index=4&type=chunk) - As of August 7, 2025, there were **32,575,407 shares** of common stock outstanding[5](index=5&type=chunk) [Special Note Regarding Forward-Looking Statements](index=4&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section highlights forward-looking statements on financing, product commercialization, and regulatory approvals, cautioning readers about inherent risks - The report contains forward-looking statements identifiable by terms such as "may," "will," "expect," and "plan," which are not historical facts[9](index=9&type=chunk) - These statements cover areas including financing, product commercialization (FemaSeed, FemBloc EU), U.S. clinical development (FemBloc), regulatory approvals, market acceptance, and the ability to continue as a going concern[9](index=9&type=chunk) - Readers are cautioned that forward-looking statements are predictions based on current expectations and projections, subject to known and unknown risks and uncertainties, and actual results may differ materially[10](index=10&type=chunk) - The company does not plan to publicly update or revise these statements, and they are excluded from the safe harbor protection of the Private Securities Litigation Reform Act of 1995[10](index=10&type=chunk) [Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) This section presents Femasys Inc.'s unaudited condensed financial statements and notes for the periods ended June 30, 2025, and December 31, 2024 [Item 1. Condensed Financial Statements](index=5&type=section&id=Item%201%20Condensed%20Financial%20Statements) This section presents Femasys Inc.'s unaudited condensed financial statements for the periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of comprehensive loss, stockholders' equity, and cash flows, along with accompanying notes [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Femasys Inc.'s condensed balance sheets detail assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Condensed Balance Sheet Highlights (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 ($) | December 31, 2024 ($) | Change ($) | % Change | | :-------------------------------- | :------------ | :---------------- | :------- | :------- | | Total Assets | $13,780,409 | $12,445,002 | $1,335,407 | 10.73% | | Total Liabilities | $12,272,974 | $10,140,580 | $2,132,394 | 21.03% | | Total Stockholders' Equity | $1,507,435 | $2,304,422 | $(796,987) | -34.58% | | Cash and cash equivalents | $3,218,067 | $3,451,761 | $(233,694) | -6.77% | | Inventory | $5,232,738 | $3,046,323 | $2,186,415 | 71.78% | | Accounts payable | $3,263,584 | $1,419,044 | $1,844,540 | 130.00% | | Convertible notes payable, net | $6,080,813 | $5,406,228 | $674,585 | 12.48% | | Accumulated deficit | $(137,681,018) | $(127,198,257) | $(10,482,761) | 8.24% | [Condensed Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) Femasys Inc.'s condensed statements of comprehensive loss for the three and six months ended June 30, 2025 and 2024 Condensed Statements of Comprehensive Loss Highlights (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | % Change | | :-------------------------------- | :----------- | :----------- | :------- | :------- | | Sales | $409,268 | $221,484 | $187,784 | 84.8% | | Cost of sales | $158,171 | $73,125 | $85,046 | 116.3% | | Research and development | $1,414,429 | $1,975,875 | $(561,446) | -28.4% | | Total operating expenses | $4,102,663 | $4,630,510 | $(527,847) | -11.4% | | Loss from operations | $(3,851,566) | $(4,482,151) | $630,585 | -14.1% | | Total other expense, net | $(734,356) | $(204,173) | $(530,183) | 259.7% | | Net loss | $(4,585,922) | $(4,684,574) | $98,652 | -2.1% | | Net loss per share (diluted) | $(0.16) | $(0.21) | $0.05 | -23.81% | Condensed Statements of Comprehensive Loss Highlights (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | % Change | | :-------------------------------- | :----------- | :----------- | :------- | :------- | | Sales | $750,532 | $492,624 | $257,908 | 52.4% | | Cost of sales | $275,437 | $161,657 | $113,780 | 70.4% | | Research and development | $4,382,901 | $3,746,606 | $636,295 | 17.0% | | Total operating expenses | $9,787,268 | $8,275,760 | $1,511,508 | 18.3% | | Loss from operations | $(9,312,173) | $(7,944,793) | $(1,367,380) | 17.2% | | Total other expense, net | $(1,174,776) | $(341,041) | $(833,735) | 244.5% | | Net loss | $(10,482,761) | $(8,284,084) | $(2,198,677) | 26.5% | | Net loss per share (diluted) | $(0.39) | $(0.38) | $(0.01) | 2.63% | [Condensed Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Femasys Inc.'s condensed statements of stockholders' equity detail changes in common stock and accumulated deficit for the six months ended June 30, 2025 - Total stockholders' equity decreased from **$2,304,422** at December 31, 2024, to **$1,507,435** at June 30, 2025, primarily due to the net loss incurred[22](index=22&type=chunk)[23](index=23&type=chunk) - The accumulated deficit increased to **$(137,681,018)** as of June 30, 2025[22](index=22&type=chunk)[23](index=23&type=chunk) - Common stock shares increased significantly due to at-the-market offerings and a June 2025 financing, contributing to additional paid-in capital[22](index=22&type=chunk)[23](index=23&type=chunk) [Condensed Statements of Cash Flows](index=12&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Femasys Inc.'s condensed statements of cash flows summarize operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 Condensed Statements of Cash Flows Highlights (Six Months Ended June 30) | Cash Flow Activity | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------------- | :------------ | :------------ | :------- | | Net cash used in operating activities | $(9,117,950) | $(8,894,780) | $(223,170) | | Net cash used in investing activities | $(193,567) | $(297,123) | $103,556 | | Net cash provided by financing activities | $9,077,823 | $1,001,724 | $8,076,099 | | Net change in cash and cash equivalents | $(233,694) | $(8,190,179) | $7,956,485 | - Cash and cash equivalents at the end of the period were **$3,218,067**[29](index=29&type=chunk) [Condensed Notes to Financial Statements](index=13&type=section&id=Condensed%20Notes%20to%20Financial%20Statements) Detailed notes accompany Femasys Inc.'s condensed financial statements, explaining accounting policies and specific financial items [(1) Organization, Nature of Business, and Liquidity](index=13&type=section&id=(1)%20Organization,%20Nature%20of%20Business,%20and%20Liquidity) This note describes Femasys Inc.'s business, product portfolio, EU approvals, liquidity, and going concern doubts - Femasys Inc. is a biomedical innovator in women's health, commercializing a portfolio of patent-protected therapeutic and diagnostic products globally, including FemaSeed, FemVue, FemCerv, FemBloc, FemChec, and FemCath[31](index=31&type=chunk) - FemBloc received CE mark certification for its delivery system (March 2025) and blended polymer component (June 2025), achieving full EU approval, and strategic distribution partnerships were announced in Spain[31](index=31&type=chunk) - The company reported a net loss of **$10,482,761** for the six months ended June 30, 2025, and an accumulated deficit of **$137,681,018**, leading to substantial doubt about its ability to continue as a going concern[37](index=37&type=chunk)[38](index=38&type=chunk) - As of June 30, 2025, cash and cash equivalents totaled **$3,218,067**, with plans to finance operations through existing cash, additional equity/debt financing, and anticipated revenue[36](index=36&type=chunk) [(2) Fair Value of Financial Instruments](index=15&type=section&id=(2)%20Fair%20Value%20of%20Financial%20Instruments) This note outlines Femasys Inc.'s application of the fair value hierarchy for financial instruments and their measurement - The company applies a fair value hierarchy (Level 1, 2, 3) to measure financial instruments[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - Certain financial instruments, including cash, accounts receivable, and other liabilities, approximate their fair value due to their short-term maturity[45](index=45&type=chunk) [(3) Cash and Cash Equivalents](index=15&type=section&id=(3)%20Cash%20and%20Cash%20Equivalents) This note details Femasys Inc.'s cash and cash equivalents, primarily money market funds and U.S. Treasury bills - Cash and cash equivalents primarily consist of money market funds and short-term U.S. Treasury bills[46](index=46&type=chunk) Cash and Cash Equivalents | Date | Amount ($) | | :--------------- | :----------- | | June 30, 2025 | $3,049,431 | | December 31, 2024 | $3,451,761 | - These are classified as Level 1 within the fair value hierarchy[46](index=46&type=chunk) [(4) Inventories](index=16&type=section&id=(4)%20Inventories) This note breaks down Femasys Inc.'s inventory, including materials, work in progress, and finished goods, and changes over time Inventory Breakdown | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :--------------- | :------------ | :---------------- | | Materials | $2,000,538 | $1,308,863 | | Work in progress | $1,567,202 | $982,630 | | Finished goods | $1,664,998 | $754,830 | | **Total Inventory** | **$5,232,738** | **$3,046,323** | - Total inventory increased by **71.78%** from December 31, 2024, to June 30, 2025[48](index=48&type=chunk) [(5) Accrued Expenses](index=16&type=section&id=(5)%20Accrued%20Expenses) This note details the composition and changes in Femasys Inc.'s accrued expenses, including compensation, clinical trial costs, and interest Accrued Expenses Breakdown | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :------------------------------ | :------------ | :---------------- | | Incentive and other compensation costs | $369,117 | $650,768 | | Clinical trial costs | $327,906 | $354,762 | | Accrued interest | $248,863 | $44,525 | | Director fees | $71,250 | $70,000 | | Other | $35,616 | $30,994 | | **Total Accrued Expenses** | **$1,052,752** | **$1,151,049** | - Total accrued expenses decreased by **8.54%** from December 31, 2024, to June 30, 2025, primarily due to a reduction in incentive and other compensation costs, partially offset by an increase in accrued interest[49](index=49&type=chunk) [(6) Revenue Recognition](index=16&type=section&id=(6)%20Revenue%20Recognition) This note explains Femasys Inc.'s revenue recognition policies, including timing of recognition and sales by geographic region - Revenue is recognized at a point in time upon shipment of goods, with control transferring to the customer at the shipping point (FOB shipping point for U.S., generally EX-Works for international)[50](index=50&type=chunk)[51](index=51&type=chunk) - The company has not had a history of significant returns, and returns are subject to prior authorization and a 30% restocking fee[51](index=51&type=chunk) Sales by Geographic Region (Six Months Ended June 30) | Primary geographical markets | 2025 ($) | 2024 ($) | Change ($) | % Change | | :--------------------------- | :----------- | :----------- | :------- | :------- | | U.S. | $678,574 | $492,624 | $185,950 | 37.75% | | International | $71,958 | $0 | $71,958 | N/A | | **Total** | **$750,532** | **$492,624** | **$257,908** | **52.35%** | [(7) Commitments and Contingencies](index=17&type=section&id=(7)%20Commitments%20and%20Contingencies) This note discusses Femasys Inc.'s legal claims assessment, liability recording, and indemnification policies for officers and directors - The company assesses legal claims and records liabilities when a loss is probable and estimable, but reported no material legal contingencies for the periods presented[54](index=54&type=chunk) - Femasys indemnifies its officers and directors, with potential future indemnification being unlimited, but exposure is limited by directors' and officers' insurance[55](index=55&type=chunk) [(8) Convertible Notes with Warrants (November 2023 Financing)](index=17&type=section&id=(8)%20Convertible%20Notes%20with%20Warrants%20(November%202023%20Financing)) This note details Femasys Inc.'s November 2023 convertible notes and warrants, including conversions and interest expense - In November 2023, the company issued **$6,850,000** in senior unsecured convertible notes (convertible at $1.18/share) and Series A and B Warrants[56](index=56&type=chunk) - In April 2025, $85,000 of convertible notes were converted into **72,033 shares** of common stock[58](index=58&type=chunk) - Series A Warrants are exercisable immediately and expire in November 2028; Series B Warrants expired unexercised in November 2024[59](index=59&type=chunk)[61](index=61&type=chunk)[117](index=117&type=chunk) - Total interest expense for the six months ended June 30, 2025, was **$950,949**, including **$746,612** in amortization of debt discount and issuance costs[62](index=62&type=chunk) [(9) Stockholders' Equity](index=18&type=section&id=(9)%20Stockholders'%20Equity) This note describes changes in Femasys Inc.'s stockholders' equity, including at-the-market offerings, public offerings, and warrant issuances - For the six months ended June 30, 2025, the company sold approximately **3.8 million shares** of common stock through its at-the-market facility for aggregate proceeds of approximately **$5.5 million**, with **$1.5 million** remaining available[64](index=64&type=chunk) - In June 2025, the company completed an underwritten public offering and concurrent private placement, selling **5,286,275 shares** for aggregate gross proceeds of **$4,510,001** (net proceeds of **$3,705,061**)[65](index=65&type=chunk)[118](index=118&type=chunk) - Warrants to purchase **105,726 shares** of common stock were issued to the underwriter as commission, exercisable beginning December 2, 2025, with a 5-year term and an exercise price of $1.0625 per share[66](index=66&type=chunk) - An Any Market Purchase Agreement was entered into with Alumni Capital LP, allowing the company to sell up to **$10 million** in common stock until December 31, 2026, at its discretion[67](index=67&type=chunk)[119](index=119&type=chunk) [(10) Equity Incentive Plans and Warrants](index=20&type=section&id=(10)%20Equity%20Incentive%20Plans%20and%20Warrants) This note outlines Femasys Inc.'s equity incentive plans, outstanding stock options, and share-based compensation expense - As of June 30, 2025, **4,398,497 stock options** were outstanding at a weighted average exercise price of $1.43[70](index=70&type=chunk) - Stockholders approved an amendment to the 2021 Equity Incentive Plan to increase authorized shares by **3,000,000**, with **3,133,620 shares** reserved for future awards[72](index=72&type=chunk) - Total share-based compensation expense for the six months ended June 30, 2025, was **$549,208**, with **$1,924,030** remaining unrecognized[76](index=76&type=chunk) - Under the Employee Stock Purchase Plan (ESPP), **49,247 shares** were issued for **$40,875** in H1 2025, and **719,668 shares** remain reserved for future awards[77](index=77&type=chunk) [(11) Related‑Party Transactions](index=21&type=section&id=(11)%20Related%E2%80%91Party%20Transactions) This note details Femasys Inc.'s transactions with related parties, including convertible notes and stock purchases by officers and directors - In November 2023, the company issued a **$5 million** convertible note and warrants to PharmaCyte Biotech, Inc., whose interim CEO serves on Femasys' board[78](index=78&type=chunk) - In November 2024, Femasys paid PharmaCyte **$300,000** in accrued interest on the convertible note through the issuance of **315,790 common shares**[78](index=78&type=chunk) - Certain officers and directors purchased **98,040 common shares** at $1.02 per share in the June 2025 private placement offering[79](index=79&type=chunk) [(12) Net Loss per Share Attributable to Common Stockholders](index=22&type=section&id=(12)%20Net%20Loss%20per%20Share%20Attributable%20to%20Common%20Stockholders) This note presents Femasys Inc.'s net loss per share calculations for basic and diluted common stockholders Net Loss per Share Attributable to Common Stockholders (Basic and Diluted) | Period | Net Loss ($) | Weighted Average Shares | Net Loss per Share ($) | | :--------------------------- | :----------- | :---------------------- | :----------------- | | Three Months Ended June 30, 2025 | $(4,585,922) | 28,880,704 | $(0.16) | | Six Months Ended June 30, 2025 | $(10,482,761) | 27,025,277 | $(0.39) | - Potentially dilutive securities totaling 10,769,754 shares (options and warrants) were excluded from diluted EPS calculations for H1 2025 due to their anti-dilutive effect[81](index=81&type=chunk) [(13) Income Taxes](index=22&type=section&id=(13)%20Income%20Taxes) This note explains Femasys Inc.'s income tax position, including the effective tax rate and valuation allowance - The effective tax rate was 0% for the six months ended June 30, 2025, and 2024, due to the company remaining in a full valuation allowance position[82](index=82&type=chunk) [(14) Segment Reporting](index=23&type=section&id=(14)%20Segment%20Reporting) This note clarifies Femasys Inc.'s single business segment operation and how chief operating decision makers assess performance - Femasys Inc. operates as a single business segment focused on the development and commercialization of therapeutic and diagnostic products for women's reproductive health[83](index=83&type=chunk) - The Chief Executive Officer and Chief Financial Officer serve as the chief operating decision makers (CODM), reviewing net income to assess performance and allocate resources[84](index=84&type=chunk) Significant Segment Expenses (Six Months Ended June 30, 2025) | Expense Category | Amount ($) | | :-------------------------------- | :----------- | | Sales | $750,532 | | Cost of sales | $275,437 | | Total research and development expense | $4,382,901 | | Sales and marketing expense | $1,893,544 | | General and administrative expense | $3,339,685 | | Net loss | $(10,482,761) | [(15) Subsequent Events](index=23&type=section&id=(15)%20Subsequent%20Events) This note reports significant events after the balance sheet date, including a promissory note for insurance premiums - In July 2025, the company executed a promissory note with AFCO Direct Insurance Premium Finance for **$367,450** to finance insurance premiums, with monthly installment payments through June 2026[86](index=86&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Femasys Inc.'s financial condition and results of operations for the three and six months ended June 30, 2025, discussing key business developments, financial performance, liquidity, and critical accounting estimates [Overview](index=24&type=section&id=Overview) This section overviews Femasys Inc.'s women's health business and key product developments, including FemBloc's EU approval - Femasys Inc. is a leading biomedical innovator in women's health, offering a broad portfolio of patent-protected therapeutic and diagnostic products globally[88](index=88&type=chunk) - Key products include FemaSeed (infertility), FemVue (fallopian tube assessment), FemCerv (cervical cancer diagnosis), and FemBloc (non-surgical permanent birth control)[88](index=88&type=chunk) - FemBloc achieved full EU approval with CE mark certification for its delivery system (March 2025) and blended polymer component (June 2025), and its U.S. pivotal clinical trial is currently enrolling participants[88](index=88&type=chunk) [Corporate Update](index=24&type=section&id=Corporate%20Update) This section highlights recent corporate milestones, including FemBloc's European commercial entry, regulatory approvals, and financing - Announced first commercial entry into Europe for FemBloc with an order of approximately **$400,000** in Spain (August 6, 2025)[89](index=89&type=chunk) - Received Australian and New Zealand regulatory approvals for FemaSeed and FemVue (July 1, 2025)[90](index=90&type=chunk) - Announced European Union Medical Device Regulation approval of FemBloc (June 25, 2025)[91](index=91&type=chunk) - Priced an underwritten public offering and concurrent private placement with gross proceeds of **$4.5 million** (May 30, 2025)[94](index=94&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) This section analyzes Femasys Inc.'s financial performance, comparing sales, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 [Comparison of the Three Months Ended June 30, 2025 and 2024](index=26&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares Femasys Inc.'s financial results for the three months ended June 30, 2025 and 2024, detailing changes in sales, expenses, and net loss Financial Performance (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | % Change | | :-------------------------------- | :----------- | :----------- | :------- | :------- | | Sales | $409,268 | $221,484 | $187,784 | 84.8% | | Cost of sales | $158,171 | $73,125 | $85,046 | 116.3% | | Research and development | $1,414,429 | $1,975,875 | $(561,446) | -28.4% | | Sales and marketing | $984,977 | $975,190 | $9,787 | 1.0% | | General and administrative | $1,616,972 | $1,611,817 | $5,155 | 0.3% | | Other expense, net | $(734,356) | $(204,173) | $(530,183) | 259.7% | | Net loss | $(4,585,922) | $(4,684,574) | $98,652 | -2.1% | | Net loss per share (diluted) | $(0.16) | $(0.21) | $0.05 | -23.81% | - Sales increased by **84.8%** due to increased sales of FemaSeed and FemVue[96](index=96&type=chunk) - R&D expenses decreased by **28.4%** primarily due to commercialization of development products into inventory and reduced clinical costs, partially offset by increased compensation[99](index=99&type=chunk) - Other expense, net, increased significantly by **259.7%** due to increased non-cash discount amortization related to convertible notes and expenses from the Any Market Purchase Agreement, partially offset by reduced interest income[103](index=103&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares Femasys Inc.'s financial results for the six months ended June 30, 2025 and 2024, detailing changes in sales, expenses, and net loss Financial Performance (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | % Change | | :-------------------------------- | :----------- | :----------- | :------- | :------- | | Sales | $750,532 | $492,624 | $257,908 | 52.4% | | Cost of sales | $275,437 | $161,657 | $113,780 | 70.4% | | Research and development | $4,382,901 | $3,746,606 | $636,295 | 17.0% | | Sales and marketing | $1,893,544 | $1,275,677 | $617,867 | 48.4% | | General and administrative | $3,339,685 | $3,114,621 | $225,064 | 7.2% | | Other expense, net | $(1,174,776) | $(341,041) | $(833,735) | 244.5% | | Net loss | $(10,482,761) | $(8,284,084) | $(2,198,677) | 26.5% | | Net loss per share (diluted) | $(0.39) | $(0.38) | $(0.01) | 2.63% | - Sales increased by **52.4%** due to sales of FemaSeed and FemVue[106](index=106&type=chunk) - R&D expenses increased by **17.0%** primarily due to increased compensation and regulatory costs, partially offset by reduced material and clinical costs[107](index=107&type=chunk) - Sales and marketing expenses increased by **48.4%** due to compensation and travel costs associated with recruiting a commercial team[108](index=108&type=chunk) - Other expense, net, increased by **244.5%** due to increased non-cash discount amortization related to convertible notes and expenses from the Any Market Purchase Agreement, partially offset by reduced interest income[112](index=112&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses Femasys Inc.'s liquidity sources, funding requirements, and substantial doubt about its ability to continue as a going concern [Sources of liquidity](index=29&type=section&id=Sources%20of%20liquidity) This section details Femasys Inc.'s funding sources, including stock sales, convertible notes, and recent public and private offerings - Operations have been financed primarily by net proceeds from common stock and convertible preferred stock sales, indebtedness, and product revenue[114](index=114&type=chunk) - As of June 30, 2025, the company had **$3,218,067** in cash and cash equivalents and an accumulated deficit of **$137,681,018**[114](index=114&type=chunk) - Through its at-the-market facility, approximately **$15.2 million** in common stock had been sold as of June 30, 2025, with approximately **$1.5 million** remaining available[115](index=115&type=chunk) - The November 2023 financing provided **$6.3 million** in net proceeds from convertible notes and warrants, with Series A Warrants potentially yielding an additional **$6.8 million**[117](index=117&type=chunk) - The June 2025 public offering and private placement generated **$3,705,061** in net proceeds[118](index=118&type=chunk) - An Any Market Purchase Agreement with Alumni Capital LP allows the company to sell up to **$10 million** in common stock until December 31, 2026, at its discretion[119](index=119&type=chunk) [Funding requirements](index=30&type=section&id=Funding%20requirements) This section outlines Femasys Inc.'s capital needs for operations, product development, and commercialization, highlighting the going concern risk - Current cash and anticipated revenues are expected to fund operations only into **early Q4 2025**, which is insufficient for the next twelve months, raising substantial doubt about the company's ability to continue as a going concern[120](index=120&type=chunk) - Additional capital is needed to fund U.S. FemBloc regulatory approval, EU commercialization, future R&D, manufacturing, and sales & marketing[121](index=121&type=chunk)[122](index=122&type=chunk) - There is no assurance that additional financing will be available on acceptable terms, and failure to secure funds could lead to delays, modifications, or termination of product development/commercialization efforts[121](index=121&type=chunk)[151](index=151&type=chunk) - Future capital requirements depend on factors such as clinical trial costs, sales/marketing establishment, product sales timing, manufacturing capabilities, intellectual property costs, and potential acquisitions[124](index=124&type=chunk)[153](index=153&type=chunk) [Cash Flows](index=32&type=section&id=Cash%20Flows) This section analyzes Femasys Inc.'s cash flow activities, including operating, investing, and financing, for the six months ended June 30, 2025 and 2024 [Comparison of the Six Months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024%20(Cash%20Flows)) This section compares Femasys Inc.'s cash flow activities for the six months ended June 30, 2025 and 2024, detailing changes in operating, investing, and financing cash Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------------- | :------------ | :------------ | :------- | | Net cash used in operating activities | $(9,117,950) | $(8,894,780) | $(223,170) | | Net cash used in investing activities | $(193,567) | $(297,123) | $103,556 | | Net cash provided by financing activities | $9,077,823 | $1,001,724 | $8,076,099 | | Net change in cash and cash equivalents | $(233,694) | $(8,190,179) | $7,956,485 | - Cash used in operating activities for H1 2025 was **$(9,117,950)**, primarily due to net loss and increased inventory, partially offset by non-cash charges and increased accounts payable[126](index=126&type=chunk) - Cash provided by financing activities significantly increased to **$9,077,823** in H1 2025, mainly from at-the-market sales and the June 2025 financing[129](index=129&type=chunk) [Critical Accounting Estimates](index=32&type=section&id=Critical%20Accounting%20Estimates) This section describes Femasys Inc.'s critical accounting estimates and policies, particularly regarding revenue recognition and financial statement preparation - The preparation of financial statements requires estimates and assumptions in accordance with U.S. GAAP[131](index=131&type=chunk) - Revenue recognition is a critical accounting policy, with revenue recognized upon shipment when the customer obtains control of goods[133](index=133&type=chunk) - Shipping terms are FOB shipping point for U.S. customers and generally EX-Works for international distributors, and the company has not experienced significant returns[134](index=134&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to Femasys Inc. for the reporting period - This item is not applicable to the company for the reporting period[135](index=135&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Femasys Inc.'s management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025. No material changes in internal control over financial reporting were identified during the quarter - Management concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[136](index=136&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended June 30, 2025[137](index=137&type=chunk) - The company acknowledges the inherent limitations of control systems, which can provide only reasonable, not absolute, assurance[138](index=138&type=chunk) [Part II. Other Information](index=34&type=section&id=Part%20II.%20Other%20Information) This section provides additional information not covered in financial statements, including legal proceedings, risk factors, and equity security sales [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) Femasys Inc. may occasionally be involved in legal proceedings but has no currently pending material actions against it as of June 30, 2025. The company believes any potential losses from future actions would not be material to its financial condition or cash flows, though they could impact operating results - The company may be involved in legal proceedings from time to time but has no currently pending material actions as of June 30, 2025[140](index=140&type=chunk) - Any reasonably possible losses from potential actions are not expected to be material to financial condition or cash flows, but could be material to operating results for a particular future period[140](index=140&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Femasys Inc. updated its risk factors to include recent deficiency letters from Nasdaq regarding non-compliance with listing requirements (Minimum Market Value of Listed Securities and Minimum Bid Price), which could lead to delisting if not resolved. The company also reiterated its need for substantial additional funding to continue operations and product development - Received Nasdaq deficiency letters for non-compliance with the **$35.0 million** Minimum Market Value of Listed Securities (MVLS) requirement (May 19, 2025) and the **$1.00** Minimum Bid Price Requirement (July 16, 2025)[142](index=142&type=chunk)[144](index=144&type=chunk) - The company has 180 calendar days to regain compliance for each deficiency (MVLS by **November 17, 2025**; Bid Price by **January 12, 2026**), with potential delisting if not resolved[143](index=143&type=chunk)[146](index=146&type=chunk) - Current cash and anticipated revenues are only sufficient to fund operations into **early Q4 2025**, necessitating substantial additional funding for commercialization and product development (e.g., U.S. FemBloc approval)[148](index=148&type=chunk) - Failure to raise additional capital could force delays, reductions in commercialization efforts, or relinquishing rights to technologies/products, potentially leading to a complete loss of investment[151](index=151&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities to report for the period - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities to report[152](index=152&type=chunk)[154](index=154&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[154](index=154&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to Femasys Inc. - Mine safety disclosures are not applicable[155](index=155&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) During the reporting period, none of Femasys Inc.'s directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or executive officers during the period[156](index=156&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including corporate documents, purchase agreements, warrants, and certifications - Exhibits include corporate documents (Certificate of Incorporation, Bylaws), purchase warrants, common stock purchase agreements, the Any Market Purchase Agreement, and various certifications (e.g., 31.1, 31.2, 32.1, 32.2)[157](index=157&type=chunk) [SIGNATURES](index=39&type=section&id=SIGNATURES) The Quarterly Report on Form 10-Q is officially signed by Kathy Lee-Sepsick, Chief Executive Officer and President, and Dov Elefant, Chief Financial Officer, on August 8, 2025 - The report was signed by Kathy Lee-Sepsick (CEO and President) and Dov Elefant (CFO) on August 8, 2025[158](index=158&type=chunk)[160](index=160&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) Femasys Inc. is a biomedical innovator in fertility and non-surgical birth control, achieving significant Q2 2025 milestones including regulatory approvals and commercial orders [Company Overview](index=1&type=section&id=Company%20Overview) Femasys Inc. is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control solutions more accessible and cost-effective for women globally - Femasys Inc. is a leading biomedical innovator in fertility and non-surgical permanent birth control solutions[1](index=1&type=chunk) [Key Corporate Highlights (2Q 2025)](index=1&type=section&id=Corporate%20Highlights%20from%202Q%202025%20to%20date) Femasys achieved significant milestones in Q2 2025, including key regulatory approvals for FemBloc in Europe and FemaSeed/FemVue in Australia and New Zealand, securing initial commercial orders, and expanding partnerships to drive global commercialization - European Union Medical Device Regulation approval for FemBloc®, the first global regulatory endorsement for their non-surgical permanent birth control solution[3](index=3&type=chunk)[5](index=5&type=chunk) - Secured first European order for FemBloc from Spain distribution partners for approximately **$400,000**[5](index=5&type=chunk) - Announced Australian and New Zealand regulatory approvals for FemaSeed® and FemVue®, a cost-effective first step in fertility[4](index=4&type=chunk)[5](index=5&type=chunk) - Announced partnership with Carolinas Fertility Institute to offer FemaSeed in its eight locations and appointed a new Chief Commercial Officer to drive global growth[4](index=4&type=chunk)[5](index=5&type=chunk) - Completed a public offering and concurrent private placement with gross proceeds of **$4.5 million**[5](index=5&type=chunk) [Financial Performance Summary](index=2&type=section&id=Financial%20Results%20Summary) Femasys reported significant sales growth in Q2 2025, driven by FemaSeed and FemVue, alongside changes in R&D expenses and net loss for both quarterly and half-yearly periods [Financial Results (Q2 2025)](index=2&type=section&id=Financial%20Results%20for%20Quarter%20Ended%20June%2030%2C%202025) For the second quarter of 2025, Femasys reported significant sales growth driven by FemaSeed and FemVue, a decrease in R&D expenses, and a reduced net loss compared to the prior year period Key Financials (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Sales | $409,268 | $221,484 | 84.8% | | Research and development expenses | $1,414,429 | $1,975,875 | -28.4% | | Net loss | ($4,585,922) | ($4,684,574) | -2.1% | | Net loss per share (basic & diluted) | ($0.16) | ($0.21) | -23.8% | - Sales increase was primarily due to sales of FemaSeed and FemVue[9](index=9&type=chunk) - R&D expense decrease was primarily due to commercialization of development products into inventory and reduced clinical costs, partially offset by increased compensation costs[9](index=9&type=chunk) - Cash and cash equivalents as of June 30, 2025, was approximately **$3.2 million**, with an accumulated deficit of approximately **$137.7 million**; current cash is expected to fund operations into early Q4 2025[9](index=9&type=chunk) [Financial Results (Six Months Ended June 30)](index=2&type=section&id=Financial%20Results%20for%20Six%20Months%20Ended%20June%2030%2C%202025) For the first half of 2025, Femasys experienced substantial sales growth, an increase in R&D expenses, and a higher net loss compared to the same period in the prior year Key Financials (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Sales | $750,532 | $492,624 | 52.4% | | Research and development expenses | $4,382,901 | $3,746,606 | 17.0% | | Net loss | ($10,482,761) | ($8,284,084) | 26.5% | | Net loss per share (basic & diluted) | ($0.39) | ($0.38) | 2.6% | - Sales increase was primarily due to sales of FemaSeed and FemVue[9](index=9&type=chunk) - R&D expense increase was primarily due to increased compensation and regulatory costs, partially offset by reduced material and development costs and clinical costs[9](index=9&type=chunk) [Condensed Financial Statements](index=3&type=section&id=Condensed%20Financial%20Statements) Femasys's condensed financial statements for Q2 2025 show increased total assets and liabilities, driven by inventory and convertible notes, alongside detailed comprehensive loss figures [Condensed Balance Sheets](index=3&type=section&id=FEMASYS%20INC.%20Condensed%20Balance%20Sheets) As of June 30, 2025, Femasys reported an increase in total assets, primarily driven by inventory, and a significant increase in total liabilities, mainly due to accounts payable and convertible notes payable, while stockholders' equity decreased Condensed Balance Sheet Highlights (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 ($) | December 31, 2024 ($) | Change ($) | | :-------------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $3,218,067 | $3,451,761 | ($233,694) | | Inventory | $5,232,738 | $3,046,323 | $2,186,415 | | Total current assets | $9,750,980 | $8,022,450 | $1,728,530 | | Total assets | $13,780,409 | $12,445,002 | $1,335,407 | | Accounts payable | $3,263,584 | $1,419,044 | $1,844,540 | | Convertible notes payable, net | $6,080,813 | $5,406,228 | $674,585 | | Total current liabilities | $10,963,607 | $8,582,869 | $2,380,738 | | Total liabilities | $12,272,974 | $10,140,580 | $2,132,394 | | Total stockholders' equity | $1,507,435 | $2,304,422 | ($796,987) | [Condensed Statements of Comprehensive Loss](index=5&type=section&id=FEMASYS%20INC.%20Condensed%20Statements%20of%20Comprehensive%20Loss) The condensed statements of comprehensive loss show increased sales and cost of sales for both the three and six-month periods ended June 30, 2025; operating expenses also increased for the six-month period, leading to higher net losses Condensed Statements of Comprehensive Loss (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | | :-------------------------------- | :----------- | :----------- | | Sales | $409,268 | $221,484 | | Cost of sales | $158,171 | $73,125 | | Research and development | $1,414,429 | $1,975,875 | | Sales and marketing | $984,977 | $975,190 | | General and administrative | $1,616,972 | $1,611,817 | | Loss from operations | ($3,851,566) | ($4,482,151) | | Net loss | ($4,585,922) | ($4,684,574) | Condensed Statements of Comprehensive Loss (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | | :-------------------------------- | :----------- | :----------- | | Sales | $750,532 | $492,624 | | Cost of sales | $275,437 | $161,657 | | Research and development | $4,382,901 | $3,746,606 | | Sales and marketing | $1,893,544 | $1,275,677 | | General and administrative | $3,339,685 | $3,114,621 | | Loss from operations | ($9,312,173) | ($7,944,793) | | Net loss | ($10,482,761) | ($8,284,084) | [Company Information](index=5&type=section&id=Company%20Information) Femasys is a biomedical innovator offering patent-protected fertility and non-surgical birth control solutions, with ongoing commercialization and clinical trials, while also outlining forward-looking statement risks [About Femasys](index=5&type=section&id=About%20Femasys) Femasys is a biomedical innovator providing patent-protected, in-office therapeutic and diagnostic products for fertility and non-surgical permanent birth control, actively commercializing its innovations globally and in the U.S. - Femasys offers a broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products for fertility and non-surgical permanent birth control[16](index=16&type=chunk) - Key fertility products include FemaSeed® Intratubal Insemination (over **twice as effective** as traditional IUI) and FemVue® for fallopian tube assessment[16](index=16&type=chunk) - FemBloc® is the first and only non-surgical, in-office alternative to surgical sterilization, with full European regulatory approval in June 2025, complemented by FemChec® diagnostic product[16](index=16&type=chunk) - Enrollment in the FINALE pivotal trial (NCT05977751) is ongoing for U.S. FDA approval of FemBloc[16](index=16&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements subject to substantial risks and uncertainties, cautioning that actual results may differ materially from expectations due to various factors, including regulatory approvals, clinical trial success, market estimates, and commercialization efforts - Forward-looking statements are subject to inherent uncertainties, risks, and assumptions, many beyond control, which could cause actual results to differ materially from expectations[20](index=20&type=chunk) - Key risk factors include the ability to obtain regulatory approvals for FemBloc, successfully complete clinical trials, demonstrate product safety and effectiveness, commercialize products, and grow sales and revenues[20](index=20&type=chunk)

Core Viewpoint - Femasys Inc. has made significant progress in securing regulatory approvals and expanding its commercialization efforts for its fertility portfolio, including the FemBloc and FemaSeed products, which aim to enhance accessibility and cost-effectiveness for women globally [3][4][19]. Group 1: Regulatory Approvals and Partnerships - The European approval of the FemBloc System marks the first global regulatory endorsement for Femasys's non-surgical permanent birth control solution, with initial commercial availability in Spain [3][7]. - Regulatory approvals for FemaSeed in Australia and New Zealand have been secured, providing opportunities for revenue growth and expansion [4][7]. - A new partnership with Carolinas Fertility Institute aims to enhance patient support and access to FemaSeed across its eight locations [4][7]. Group 2: Financial Performance - Sales for the second quarter of 2025 increased by $187,784, or 84.8%, reaching $409,268 compared to $221,484 in the same period of 2024, driven by FemaSeed and FemVue sales [8][16]. - Research and development expenses decreased by $561,446, or 28.4%, to $1,414,429 for the second quarter of 2025, primarily due to commercialization efforts and reduced clinical costs [8][16]. - The net loss for the second quarter of 2025 was $4,585,922, or ($0.16) per share, compared to a net loss of $4,684,574, or ($0.21) per share, for the same period in 2024 [8][17]. Group 3: Product Innovations - Femasys's fertility portfolio includes FemaSeed, which is over twice as effective as traditional intrauterine insemination (IUI) and has a comparable safety profile [18]. - FemBloc is the first non-surgical, in-office alternative to surgical sterilization, with full regulatory approval in Europe, and aims to provide a safer and more cost-effective solution [19]. - The FemChec diagnostic product complements FemBloc by providing an ultrasound-based test to confirm procedural success [19].