ATLANTA, March 21, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a leading biomedical company focused on addressing the significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, invites investors to join management in a Fireside Chat with Jones Trading Analyst Catherine Novack to discuss the current treatment landscape for infertility treatment in women. Those interested in attending the event, which will be held vir ...

-- In the severe male factor cohort, findings show 24% of women became pregnant after FemaSeed -- -- FemaSeed pregnancy rate by cycle was more than double historic intrauterine insemination (IUI) rate -- -- Of those with a successful pregnancy, a majority required only one FemaSeed procedure -- -- No new safety concerns were reported -- ATLANTA, March 20, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a ...

-- CEO Kathy Lee-Sepsick and Chief Medical Officer James Liu to Join Jones Trading Analyst Catherine Novack in a Conversation on Current Treatment Options in Infertility Including FemaSeed® at 1PM ET -- ATLANTA, March 13, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a biomedical company focused on meeting the significant unmet needs for women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces it will participate in a Fireside Chat ...

-- Paving the way forward for the broader commercial availability of FemaSeed, an accessible, safe, and cost effective alternative to IVF -- -- Ongoing uncertainty following recent Alabama Supreme Court Ruling creates continued anticipation with top-line pivotal data expected to be announced during Q1 2024 -- ATLANTA, March 06, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a biomedical company focused on meeting the significant unmet needs for women worldwide with a broad portfolio of in-office, acce ...

-- Femasys readies for the commercial launch of FemaSeed® in the U.S. amidst the uncertainty following the Alabama Supreme Court Ruling on how to handle embryos used for in vitro fertilization (IVF) -- -- Femasys to announce top-line data from recently completed pivotal clinical trial for FemaSeed in first quarter 2024 -- ATLANTA, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a biomedical company focused on meeting the significant unmet needs for women worldwide with a broad portfolio of in- ...

-- Seasoned sales and marketing executive with 25 years of experience leading public and private healthcare companies throughout various stages of commercialization will lead commercial launch of FemaSeed -- ATLANTA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and dia ...

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) [Registrant Information](index=1&type=section&id=Registrant%20Information) Femasys Inc. filed its Quarterly Report on Form 10-Q for the period ended September 30, 2023, is incorporated in Delaware, trades on Nasdaq under FEMY, and had 21,649,623 shares outstanding as of November 13, 2023 - Femasys Inc. filed its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023[2](index=2&type=chunk) - The registrant is a non-accelerated filer, a smaller reporting company, and an emerging growth company, electing not to use the extended transition period for new or revised financial accounting standards[3](index=3&type=chunk)[4](index=4&type=chunk) Registrant Key Information | Metric | Value | | :--- | :--- | | Commission file number | 001-40492 | | State of incorporation | Delaware | | Trading symbol | FEMY | | Exchange | The Nasdaq Capital Market | | Common stock outstanding (as of Nov 13, 2023) | 21,649,623 shares | [SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements Disclaimer](index=3&type=section&id=Forward-Looking%20Statements%20Disclaimer) This quarterly report contains forward-looking statements based on current expectations and projections, which are subject to risks and uncertainties that may cause actual results to differ materially, and the company does not plan to update them publicly - This report contains forward-looking statements, identifiable by words like “may,” “will,” “expect,” “plan,” “believe,” “estimate,” and are based on the company's current expectations and projections regarding future events and financial trends[9](index=9&type=chunk)[11](index=11&type=chunk) - Forward-looking statements are inherently subject to known and unknown risks, uncertainties, and assumptions, including those described in “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations,” where actual results may differ materially from projections[11](index=11&type=chunk) - The company does not plan to publicly update or revise any forward-looking statements, and these statements do not enjoy the safe harbor protection provided by the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933[11](index=11&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=Part%20I.%20Financial%20Information) [ITEM I. Financial Statements](index=5&type=section&id=ITEM%20I.%20Financial%20Statements) This section presents Femasys Inc.'s unaudited consolidated financial statements, including balance sheets, statements of comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's organization, business, accounting policies, and specific financial items - The financial statements are unaudited and prepared in accordance with SEC rules and U.S. GAAP, with certain information and note disclosures condensed or omitted as permitted by these rules and regulations[32](index=32&type=chunk)[33](index=33&type=chunk) [Balance Sheets](index=5&type=section&id=Balance%20Sheets) As of September 30, 2023, Femasys Inc.'s total assets decreased by 12.1% to **$14.85 million** from **$16.90 million** at December 31, 2022, primarily due to reduced cash and cash equivalents, while total liabilities significantly increased by 166.8% to **$4.41 million**, and stockholders' equity declined by 31.5% to **$10.44 million** Key Balance Sheet Data (as of September 30) | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Total assets | $14,853,537 | $16,895,570 | $(2,042,033) | -12.1% | | Total liabilities | $4,409,935 | $1,653,051 | $2,756,884 | 166.8% | | Total stockholders' equity | $10,443,602 | $15,242,519 | $(4,798,917) | -31.5% | | Cash and cash equivalents | $8,692,435 | $12,961,936 | $(4,269,501) | -32.9% | | Total current assets | $10,225,032 | $14,131,491 | $(3,906,459) | -27.6% | | Total current liabilities | $2,186,947 | $1,527,809 | $659,138 | 43.1% | | Long-term lease liabilities | $2,168,969 | $28,584 | $2,140,385 | 7488.8% | [Statements of Comprehensive Loss](index=7&type=section&id=Statements%20of%20Comprehensive%20Loss) For the three months ended September 30, 2023, Femasys Inc. reported a net loss of **$4.00 million**, a 34.0% increase year-over-year, driven by a 29.7% sales decrease and a 29.5% rise in total operating expenses, while the nine-month net loss increased by 15.7% to **$9.84 million** due to similar operational expense growth Key Statements of Comprehensive Loss Data **For the Three Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $244,361 | $347,456 | $(103,095) | -29.7% | | Gross profit | $158,175 | $216,005 | $(57,830) | -26.8% | | R&D expenses | $2,072,830 | $1,648,160 | $424,670 | 25.8% | | Sales and marketing expenses | $70,883 | $90,374 | $(19,491) | -21.6% | | General and administrative expenses | $1,970,408 | $1,395,063 | $575,345 | 41.2% | | Total operating expenses | $4,239,439 | $3,273,194 | $966,245 | 29.5% | | Net loss | $(3,996,905) | $(2,982,843) | $(1,014,062) | 34.0% | | Net loss per share (basic and diluted) | $(0.26) | $(0.25) | $(0.01) | 4.0% | **For the Nine Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $858,859 | $971,974 | $(113,115) | -11.6% | | Gross profit | $557,084 | $615,495 | $(58,411) | -9.5% | | R&D expenses | $5,137,441 | $4,542,147 | $595,294 | 13.1% | | Sales and marketing expenses | $444,678 | $222,414 | $222,264 | 99.9% | | General and administrative expenses | $4,642,182 | $4,024,356 | $617,826 | 15.4% | | Total operating expenses | $10,615,984 | $9,215,397 | $1,400,587 | 15.2% | | Net loss | $(9,836,670) | $(8,499,974) | $(1,336,696) | 15.7% | | Net loss per share (basic and diluted) | $(0.74) | $(0.72) | $(0.02) | 2.8% | [Statements of Stockholders' Equity](index=8&type=section&id=Statements%20of%20Stockholders'%20Equity) As of September 30, 2023, total stockholders' equity was **$10.44 million**, a decrease from **$15.24 million** at December 31, 2022, primarily due to a **$9.84 million** net loss, partially offset by **$3.35 million** net proceeds from April 2023 financing, warrant exercises, and stock-based compensation Changes in Stockholders' Equity (Nine Months Ended September 30) | Item | Amount | | :--- | :--- | | Balance at December 31, 2022 | $15,242,519 | | Issuance of common stock and warrants from April 2023 financing (net of issuance costs) | $3,345,996 | | Exercise of prepaid warrants | $188 | | Exercise of common warrants | $1,059,975 | | Stock-based compensation expense | $626,529 | | Net loss | $(9,836,670) | | Balance at September 30, 2023 | $10,443,602 | [Statements of Cash Flows](index=10&type=section&id=Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, Femasys Inc.'s cash and cash equivalents decreased by **$4.27 million**, compared to an **$8.78 million** decrease in the prior year, with **$8.24 million** net cash used in operating activities, **$99 thousand** in investing activities, and **$4.07 million** net cash provided by financing activities, mainly from April 2023 equity financing and warrant exercises - In the first nine months of 2023, cash provided by financing activities primarily stemmed from **$4.97 million** in proceeds from the April 2023 issuance of common stock and warrants, along with proceeds from the exercise of prepaid and common warrants[115](index=115&type=chunk) Key Cash Flow Data (Nine Months Ended September 30) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,244,566) | $(7,864,086) | | Net cash used in investing activities | $(99,018) | $(313,598) | | Net cash provided by/(used in) financing activities | $4,074,083 | $(599,695) | | Net change in cash and cash equivalents | $(4,269,501) | $(8,777,379) | | Cash and cash equivalents at end of period | $8,692,435 | $16,005,650 | [Notes to Financial Statements](index=11&type=section&id=Notes%20to%20Financial%20Statements) The notes provide detailed information on the company's organization, liquidity, accounting policies, inventory, accrued expenses, clinical holdback, revenue recognition, commitments, notes payable, leases, stockholders' equity, equity incentive plans, and net loss per share, highlighting the impact of April 2023 equity financing and subsequent warrant exercises on liquidity and equity - Femasys Inc. is a biomedical company focused on women's reproductive health, possessing an extensive intellectual property portfolio and in-house manufacturing capabilities, with key products including FemBloc® (permanent contraception) and FemaSeed® (intrauterine insemination)[30](index=30&type=chunk)[31](index=31&type=chunk) - As of September 30, 2023, the company had **$8.69 million** in cash and cash equivalents, with existing cash and recent financing proceeds expected to support operations for at least the next 12 months, though additional funding is required to advance FemBloc's clinical development and commercialization[35](index=35&type=chunk)[38](index=38&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - In April 2023, the company completed an equity financing through a registered direct offering and concurrent private placement, generating **$3.90 million** in gross proceeds and **$3.35 million** net proceeds, followed by significant cash inflows from common warrant exercises in September and October 2023[56](index=56&type=chunk)[67](index=67&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk)[106](index=106&type=chunk) [(1) Organization, Nature of Business, and Liquidity](index=11&type=section&id=(1)%20Organization,%20Nature%20of%20Business,%20and%20Liquidity) Femasys Inc. is a biomedical company focused on women's reproductive health, offering permanent contraception and infertility solutions with extensive IP and internal manufacturing, and while **$8.69 million** in cash as of September 30, 2023, is expected to fund operations for at least 12 months, additional financing is needed for FemBloc's clinical development and commercialization - Femasys Inc. is a biomedical company focused on women's reproductive health, offering solutions including FemBloc® (permanent contraception) and FemaSeed® (intrauterine insemination)[30](index=30&type=chunk)[31](index=31&type=chunk) - The company holds an extensive intellectual property portfolio, including design and utility patents in the U.S. and key overseas markets, and possesses in-house research, development, and manufacturing capabilities[31](index=31&type=chunk) - The company anticipates increased losses in the coming years until FemBloc receives FDA approval and market launch, planning to support operations and R&D through existing cash, equity/debt financing, and sales revenue from FemVue and FemaSeed[35](index=35&type=chunk)[36](index=36&type=chunk) Liquidity Overview | Metric | September 30, 2023 | | :--- | :--- | | Cash and cash equivalents | $8,692,435 | | Net loss for the nine months ended September 30, 2023 | $(9,836,670) | | Estimated future operating capital sufficiency | At least 12 months | [(2) Cash and Cash Equivalents](index=12&type=section&id=(2)%20Cash%20and%20Cash%20Equivalents) As of September 30, 2023, the company's money market funds within cash and cash equivalents totaled **$7.33 million**, a decrease from **$12.55 million** at December 31, 2022 Money Market Funds | Date | Amount | | :--- | :--- | | September 30, 2023 | $7,330,371 | | December 31, 2022 | $12,553,557 | | Change | $(5,223,186) | | Change % | -41.6% | [(3) Inventories](index=12&type=section&id=(3)%20Inventories) As of September 30, 2023, the company's net inventory increased to **$602.7 thousand** from **$436.7 thousand** at December 31, 2022, with growth in raw materials and finished goods offsetting a decline in work-in-process, and a reserve for slow-moving, obsolete, or unusable FemVue products was recorded - The reserve for slow-moving, obsolete, or unusable FemVue products increased from **$2,103** at December 31, 2022, to **$3,560** at September 30, 2023[42](index=42&type=chunk) Inventory Composition (Net) | Inventory Category | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Raw materials | $361,569 | $244,498 | | Work-in-process | $51,358 | $100,453 | | Finished goods | $189,741 | $91,772 | | Total net inventory | $602,668 | $436,723 | [(4) Accrued Expenses](index=12&type=section&id=(4)%20Accrued%20Expenses) As of September 30, 2023, total accrued expenses increased to **$569.4 thousand** from **$456.7 thousand** at December 31, 2022, primarily due to significant increases in compensation costs and director fees, partially offset by decreases in clinical trial costs and franchise taxes Accrued Expenses Composition | Accrued Expense Category | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Clinical trial costs | $313,029 | $333,440 | | Compensation costs | $155,192 | $85,191 | | Franchise taxes | $0 | $26,886 | | Director fees | $90,000 | $0 | | Other | $11,221 | $11,197 | | Total accrued expenses | $569,442 | $456,714 | [(5) Clinical Holdback](index=13&type=section&id=(5)%20Clinical%20Holdback) As of September 30, 2023, the clinical holdback liability balance was **$126.1 thousand**, with **$72.1 thousand** classified as current and **$54.0 thousand** as long-term, reflecting **$4,529** in new holdbacks and **$20,299** in payments during the period Changes in Clinical Holdback Liability (Nine Months Ended September 30) | Item | Amount | | :--- | :--- | | Balance at December 31, 2022 | $141,864 | | Clinical holdback retained | $4,529 | | Clinical holdback paid | $(20,299) | | Balance at September 30, 2023 | $126,094 | | Less: Current portion | $(72,075) | | Long-term portion | $54,019 | [(6) Revenue Recognition](index=13&type=section&id=(6)%20Revenue%20Recognition) The company primarily recognizes revenue from FemVue product sales at the point of shipment with standard 30-to-60-day payment terms, reporting **$800.8 thousand** in U.S. sales and **$58.0 thousand** in international sales for the first nine months of 2023, totaling **$858.9 thousand**, a decrease from the prior year, with no significant history of returns - The company recognizes revenue at the point of shipment based on contract pricing and standard 30-to-60-day payment terms, with all revenue recognized at a point in time and no over-time recognition[46](index=46&type=chunk)[119](index=119&type=chunk) - Products are shipped to U.S. customers via common carrier, with customers assuming freight costs and FOB shipping point control, while international distributors typically have EX-Works shipping terms, and the company has no significant history of returns[47](index=47&type=chunk)[120](index=120&type=chunk) Sales by Geographic Region (Primarily from FemVue) **For the Three Months Ended September 30:** | Market | 2023 | 2022 | | :--- | :--- | :--- | | U.S. | $244,361 | $289,642 | | International | $0 | $57,814 | | Total | $244,361 | $347,456 | **For the Nine Months Ended September 30:** | Market | 2023 | 2022 | | :--- | :--- | :--- | | U.S. | $800,814 | $856,115 | | International | $58,045 | $115,859 | | Total | $858,859 | $971,974 | [(7) Commitments and Contingencies](index=13&type=section&id=(7)%20Commitments%20and%20Contingencies) The company may be involved in legal claims or litigation but, as of September 30, 2023, and December 31, 2022, there were no material legal contingencies requiring accrual or disclosure, and the company indemnifies directors and officers under Delaware law and its bylaws, backed by D&O liability insurance - The company may be involved in legal claims or litigation, but as of September 30, 2023, and December 31, 2022, there were no material legal contingencies requiring accrual or disclosure[49](index=49&type=chunk) - The company indemnifies its directors and officers under Delaware law and its bylaws, and has purchased Directors and Officers liability insurance to limit potential unlimited indemnification amounts[50](index=50&type=chunk) [(8) Notes Payable](index=13&type=section&id=(8)%20Notes%20Payable) In July 2023, the company entered into a **$469.0 thousand** promissory note with AFCO Credit Corporation at an 8.587% annual interest rate to finance insurance premiums, resulting in an AFCO note principal balance of **$283.3 thousand** as of September 30, 2023, an increase from **$141.3 thousand** at December 31, 2022 - In July 2023, the company entered into a promissory note with AFCO Credit Corporation to finance **$469,042** in insurance premiums at an 8.587% annual interest rate[51](index=51&type=chunk) AFCO Notes Payable Principal Balance | Date | Amount | | :--- | :--- | | September 30, 2023 | $283,334 | | December 31, 2022 | $141,298 | | Change | $142,036 | | Change % | 100.5% | AFCO Notes Payable Interest Expense **For the Three Months Ended September 30:** | Year | Amount | | :--- | :--- | | 2023 | $7,998 | | 2022 | $5,352 | **For the Nine Months Ended September 30:** | Year | Amount | | :--- | :--- | | 2023 | $9,317 | | 2022 | $7,235 | [(9) Leases](index=14&type=section&id=(9)%20Leases) In July 2023, the company extended its operating lease agreement for its Suwanee, Georgia office facility, incurring **$3.32 million** in future payments over 63 months, which led to a **$2.50 million** increase in right-of-use assets and lease liabilities - In July 2023, the company extended its operating lease agreement, requiring **$3,321,025** in future payments over 63 months[54](index=54&type=chunk) - The lease extension resulted in a **$2,496,968** increase in right-of-use assets and lease liabilities[54](index=54&type=chunk) [(10) Stockholders' Equity](index=14&type=section&id=(10)%20Stockholders'%20Equity) As of September 30, 2023, the company had 15,992,869 shares of common stock outstanding with no dividends declared or paid, having completed an April 2023 equity financing that issued 1,318,000 common shares and warrants to purchase 3,196,722 common shares, generating **$3.90 million** gross and **$3.35 million** net proceeds, and also re-established an 'at-the-market' offering facility in October 2023 - In April 2023, the company completed an equity financing through a registered direct offering and concurrent private placement, issuing 1,318,000 shares of common stock and prepaid and common warrants to purchase 3,196,722 shares of common stock, generating **$3,899,813** in gross proceeds and **$3,352,049** in net proceeds[56](index=56&type=chunk)[106](index=106&type=chunk) - The company established an 'at-the-market' offering facility in July 2022 with Piper Sandler & Co., allowing for the issuance of up to **$8.80 million** in common stock, which was suspended in April 2023 and reinstated in October 2023, authorizing sales of up to **$16.70 million** in shares[55](index=55&type=chunk)[105](index=105&type=chunk) Common Stock Outstanding | Date | Shares Outstanding | | :--- | :--- | | September 30, 2023 | 15,992,869 | | November 13, 2023 | 21,649,623 | [(11) Equity Incentive Plans and Warrants](index=14&type=section&id=(11)%20Equity%20Incentive%20Plans%20and%20Warrants) As of September 30, 2023, the company had 2,079,271 stock options outstanding with a weighted-average exercise price of **$2.00**, having granted 1,150,000 employee options and 73,000 non-employee options in the first nine months of 2023, while prepaid warrants from the April 2023 financing were fully exercised by June 2023, and some common and placement agent warrants were exercised in September 2023, generating **$1.06 million** in cash, leaving 2,400,000 common warrants and 68,809 placement agent warrants unexercised - Prepaid warrants issued in the April 2023 financing were fully exercised by June 2023, and in September 2023, 796,722 common warrants and 122,994 placement agent warrants were exercised, generating **$1,059,975** in cash proceeds[72](index=72&type=chunk) - As of September 30, 2023, 2,400,000 common warrants and 68,809 placement agent warrants remained unexercised[72](index=72&type=chunk) Stock Option Activity (Nine Months Ended September 30) | Metric | Number of Stock Options | Weighted-Average Exercise Price | | :--- | :--- | :--- | | Outstanding at December 31, 2022 | 931,550 | $3.97 | | Granted | 1,223,000 | $0.50 (weighted average) | | Forfeited | (75,279) | $2.09 (weighted average) | | Outstanding at September 30, 2023 | 2,079,271 | $2.00 | | Vested and exercisable at September 30, 2023 | 1,217,298 | $2.62 | Stock-Based Compensation Expense **For the Three Months Ended September 30:** | Category | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $79,561 | $10,820 | | Sales and marketing | $623 | $1,515 | | General and administrative | $424,175 | $39,427 | | Total | $504,359 | $51,762 | **For the Nine Months Ended September 30:** | Category | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $131,812 | $73,395 | | Sales and marketing | $(1,319) | $3,857 | | General and administrative | $496,036 | $81,036 | | Total | $626,529 | $158,288 | [(12) Net Loss per Share Attributable to Common Stockholders](index=16&type=section&id=(12)%20Net%20Loss%20per%20Share%20Attributable%20to%20Common%20Stockholders) For the three and nine months ended September 30, 2023, basic and diluted net loss per share attributable to common stockholders was **$0.26** and **$0.74**, respectively, with all potentially dilutive securities, including stock options and warrants, excluded from diluted net loss per share calculations due to their anti-dilutive effect given the company's net loss position - Due to the company's net loss position, potentially dilutive securities such as stock options and warrants are excluded from diluted net loss per share calculations as they are anti-dilutive[73](index=73&type=chunk) Net Loss per Share Attributable to Common Stockholders **For the Three Months Ended September 30:** | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net loss attributable to common stockholders (basic and diluted) | $(3,996,905) | $(2,982,843) | | Weighted-average shares used in computing net loss per share (basic and diluted) | 15,093,147 | 11,813,610 | | Net loss per share (basic and diluted) | $(0.26) | $(0.25) | **For the Nine Months Ended September 30:** | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net loss attributable to common stockholders (basic and diluted) | $(9,836,670) | $(8,499,974) | | Weighted-average shares used in computing net loss per share (basic and diluted) | 13,369,462 | 11,810,289 | | Net loss per share (basic and diluted) | $(0.74) | $(0.72) | [(13) Subsequent Events](index=16&type=section&id=(13)%20Subsequent%20Events) In October 2023, 2,400,000 common warrants were exercised, generating **$2.63 million** in cash proceeds, and the company reactivated its 'at-the-market' offering agreement, selling 3,256,754 shares through this facility for **$7.66 million** in gross cash proceeds - In October 2023, 2,400,000 common warrants were exercised, generating **$2,628,000** in cash proceeds[74](index=74&type=chunk) - In October 2023, the company reactivated its 'at-the-market' offering agreement and sold 3,256,754 shares, generating **$7,661,587** in gross cash proceeds[74](index=74&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Femasys Inc.'s financial condition and operating results for the period ended September 30, 2023, covering company overview, recent corporate and clinical developments, operational performance, liquidity, capital resources, and critical accounting estimates, as the company advanced its reproductive health product pipeline and conducted financing activities - Femasys Inc. is a biomedical company focused on women's reproductive health, possessing an extensive intellectual property portfolio and in-house manufacturing capabilities, with key products including FemBloc (permanent contraception) and FemaSeed (intrauterine insemination)[77](index=77&type=chunk) - The company achieved several corporate and clinical milestones during the reporting period, including product approvals and FDA 510(k) clearance for FemaSeed in Canada, and FDA approval and enrollment initiation for FemBloc's pivotal clinical trial[78](index=78&type=chunk)[80](index=80&type=chunk)[82](index=82&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - The company secured additional liquidity through equity financing and warrant exercises to support operations and product development, but still anticipates needing more capital to complete clinical development and commercialization of its primary product candidates[103](index=103&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk) [Overview](index=17&type=section&id=Overview) Femasys Inc. is a women-founded and led biomedical company dedicated to providing office-accessible solutions for women globally, leveraging its extensive IP portfolio and internal manufacturing capabilities, primarily focusing on reproductive health with FemBloc for permanent contraception and FemaSeed for intrauterine insemination, the latter receiving FDA 510(k) clearance in September 2023 - Femasys is a women-founded and led biomedical company focused on addressing unmet needs for women globally, offering a wide range of office-accessible solutions[77](index=77&type=chunk) - The company holds an intellectual property portfolio of over 150 global patents and possesses in-house chemistry, manufacturing, and control (CMC) as well as device manufacturing capabilities[77](index=77&type=chunk) - The company primarily focuses on reproductive health, with key product candidates including FemBloc for permanent contraception and FemaSeed for intrauterine insemination, which received FDA 510(k) clearance in September 2023[77](index=77&type=chunk) [Corporate Update](index=17&type=section&id=Corporate%20Update) Femasys Inc. achieved significant corporate milestones, including Health Canada approval for FemaSeed, FemCerv, and FemCath sales, FDA IDE approval and enrollment initiation for FemBloc's pivotal clinical trial, a new U.S. patent for FemBloc, FDA 510(k) clearance for FemaSeed, a Health Canada medical device establishment license, and regaining Nasdaq minimum bid price compliance - Health Canada approved the sale of FemaSeed, FemCerv, and FemCath in Canada[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - The FDA approved the IDE for FemBloc's pivotal clinical trial, with enrollment initiated in August 2023[80](index=80&type=chunk)[81](index=81&type=chunk) - The company received FDA 510(k) clearance for FemaSeed in September 2023 and a Health Canada Medical Device Establishment License in August 2023, enabling direct sales of FemaSeed, FemVue, FemCath, and FemCerv in Canada[82](index=82&type=chunk) - The company regained Nasdaq minimum bid price compliance in October 2023[83](index=83&type=chunk) [Clinical Update](index=18&type=section&id=Clinical%20Update) Femasys Inc. advanced its clinical development, with FemaSeed's pivotal trial redesigned to focus on male factor infertility patients, expected to complete enrollment in Q4 2023 and receiving FDA 510(k) clearance in September 2023, while FemBloc's FINALE pivotal trial received FDA IDE approval and commenced enrollment to assess safety and efficacy, with pregnancy rate as the primary endpoint, and plans for an interim analysis and five-year follow-up - FemaSeed's pivotal trial design was updated to focus on male factor infertility patients, with enrollment expected to complete in Q4 2023, and received FDA 510(k) clearance in September 2023[85](index=85&type=chunk) - FemBloc's FINALE pivotal trial received FDA IDE approval and initiated enrollment, aiming to evaluate its safety and effectiveness, with pregnancy rate as the primary endpoint[86](index=86&type=chunk) - The FemBloc trial design includes an initial safety data enrollment of 50 women, a clinical data endpoint interim analysis after 300 women use FemBloc for one year, and planned five-year annual follow-ups[86](index=86&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) For the three and nine months ended September 30, 2023, Femasys Inc. experienced decreased sales but improved gross margins, while increased research and development, sales and marketing, and general and administrative expenses led to expanded operating and net losses, partially offset by significant growth in interest income Operating Results Overview **For the Three Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $244,361 | $347,456 | $(103,095) | -29.7% | | Gross profit | $158,175 | $216,005 | $(57,830) | -26.8% | | Total operating expenses | $4,239,439 | $3,273,194 | $966,245 | 29.5% | | Operating loss | $(4,081,264) | $(3,057,189) | $(1,024,075) | 33.5% | | Net loss | $(3,996,905) | $(2,982,843) | $(1,014,062) | 34.0% | **For the Nine Months Ended September 30:** | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $858,859 | $971,974 | $(113,115) | -11.6% | | Gross profit | $557,084 | $615,495 | $(58,411) | -9.5% | | Total operating expenses | $10,615,984 | $9,215,397 | $1,400,587 | 15.2% | | Operating loss | $(10,058,900) | $(8,599,902) | $(1,458,998) | 17.0% | | Net loss | $(9,836,670) | $(8,499,974) | $(1,336,696) | 15.7% | [Comparison of the Three Months Ended September 30, 2023 and 2022](index=18&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20September%2030,%202023%20and%202022) For the three months ended September 30, 2023, sales decreased by 29.7% to **$244.4 thousand**, driven by reduced international and U.S. sales, yet gross margin improved from 62.2% to 64.7% due to manufacturing efficiencies, while R&D expenses rose 25.8% to **$2.07 million**, sales and marketing expenses fell 21.6%, general and administrative expenses increased 41.2%, and net loss expanded by 34.0% to **$4.00 million** - Net other income (expense) increased by 13.5% to **$84.4 thousand**, primarily due to higher interest income[94](index=94&type=chunk) Operating Results for the Three Months Ended September 30 | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $244,361 | $347,456 | $(103,095) | -29.7% | | Cost of sales | $86,186 | $131,451 | $(45,265) | -34.4% | | Gross profit | $158,175 | $216,005 | $(57,830) | -26.8% | | Gross margin percentage | 64.7% | 62.2% | 2.5% | 4.0% | | Research and development expenses | $2,072,830 | $1,648,160 | $424,670 | 25.8% | | Sales and marketing expenses | $70,883 | $90,374 | $(19,491) | -21.6% | | General and administrative expenses | $1,970,408 | $1,395,063 | $575,345 | 41.2% | | Net loss | $(3,996,905) | $(2,982,843) | $(1,014,062) | 34.0% | [Comparison of the Nine months ended September 30, 2023 and 2022](index=19&type=section&id=Comparison%20of%20the%20Nine%20months%20ended%20September%2030,%202023%20and%202022) For the nine months ended September 30, 2023, sales decreased by 11.6% to **$858.9 thousand**, primarily due to reduced international and U.S. sales, while gross margin improved from 63.3% to 64.9%, R&D expenses increased 13.1% to **$5.14 million**, sales and marketing expenses surged 99.9% to **$444.7 thousand**, general and administrative expenses rose 15.4%, and net loss expanded by 15.7% to **$9.84 million** - Net other income (expense) significantly increased by 122.4% to **$222.2 thousand**, primarily due to higher interest income[102](index=102&type=chunk) Operating Results for the Nine Months Ended September 30 | Metric | 2023 | 2022 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Sales | $858,859 | $971,974 | $(113,115) | -11.6% | | Cost of sales | $301,775 | $356,479 | $(54,704) | -15.3% | | Gross profit | $557,084 | $615,495 | $(58,411) | -9.5% | | Gross margin percentage | 64.9% | 63.3% | 1.6% | 2.5% | | Research and development expenses | $5,137,441 | $4,542,147 | $595,294 | 13.1% | | Sales and marketing expenses | $444,678 | $222,414 | $222,264 | 99.9% | | General and administrative expenses | $4,642,182 | $4,024,356 | $617,826 | 15.4% | | Net loss | $(9,836,670) | $(8,499,974) | $(1,336,696) | 15.7% | [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$8.69 million** in cash and cash equivalents with an accumulated deficit of **$104 million**, primarily funding operations through common stock, convertible preferred stock, and debt financing, having recently secured significant cash inflows from its 'at-the-market' facility and April 2023 financing, and expects existing funds to support operations for at least 12 months, though additional financing is required for clinical development and commercialization of key product candidates - The company primarily funds its operations through the sale of common stock, convertible preferred stock, debt, and product revenue[103](index=103&type=chunk) - In October 2023, the company sold 3,256,754 shares through its reinstated 'at-the-market' facility, generating **$7,661,587** in gross cash proceeds, in addition to **$3,352,049** net proceeds from the April 2023 financing and further cash inflows from warrant exercises in September and October 2023[105](index=105&type=chunk)[106](index=106&type=chunk) - The company anticipates needing additional capital to complete clinical development, regulatory approval, development, and commercialization of its primary product candidates, warning that failure to obtain sufficient financing may force termination or delay of product development[108](index=108&type=chunk) Liquidity Overview | Metric | September 30, 2023 | | :--- | :--- | | Cash and cash equivalents | $8,692,435 | | Accumulated deficit | $(103,971,175) | | Estimated time existing funds can support operations | At least 12 months | [Cash Flows](index=21&type=section&id=Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities was **$8.24 million**, primarily due to net loss, partially offset by non-cash expenses and changes in working capital, while net cash used in investing activities was **$99 thousand** for property and equipment, and net cash provided by financing activities was **$4.07 million**, mainly from equity issuance and warrant exercises - Net cash used in operating activities for the first nine months of 2023 was primarily attributable to a **$9,836,670** net loss, partially offset by non-cash expenses such as depreciation and amortization, right-of-use asset amortization, stock-based compensation expense, and loss on disposal of assets[110](index=110&type=chunk) - Net cash provided by financing activities for the first nine months of 2023 primarily resulted from **$4,965,021** in proceeds from the issuance of common stock and warrants, partially offset by financing issuance costs, notes payable repayments, and lease obligation payments[115](index=115&type=chunk) Cash Flow Overview (Nine Months Ended September 30) | Cash Flow Category | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,244,566) | $(7,864,086) | | Net cash used in investing activities | $(99,018) | $(313,598) | | Net cash provided by/(used in) financing activities | $4,074,083 | $(599,695) | | Net change in cash and cash equivalents | $(4,269,501) | $(8,777,379) | [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) This section discusses critical accounting estimates involved in preparing the company's financial statements, including revenue recognition and accrued expenses, where financial statements are prepared under U.S. GAAP requiring estimates and assumptions for assets, liabilities, revenue, and expenses, with revenue recognized when control of goods transfers and accrued expenses estimated for unbilled third-party R&D services - The company's financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions for assets, liabilities, revenue, expenses, and related disclosures[117](index=117&type=chunk) - Revenue is recognized when customers obtain control of promised goods, with all revenue recognized at a point in time and no over-time recognition, and the company has no multiple performance obligations or significant history of returns[119](index=119&type=chunk)[120](index=120&type=chunk) - Accrued expenses primarily relate to research and development activities by third-party service providers, estimated based on services rendered but not yet invoiced, and are adjusted to actual costs[121](index=121&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable - Quantitative and qualitative disclosures about market risk are not applicable to this section[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Company management assessed the effectiveness of disclosure controls and procedures as of September 30, 2023, concluding they were effective at a reasonable assurance level, with no significant changes in internal control over financial reporting during the period, while acknowledging inherent limitations of control systems in preventing all errors and fraud - Company management, including the Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of disclosure controls and procedures as of September 30, 2023, concluding they were effective at a reasonable assurance level[123](index=123&type=chunk) - No significant changes in internal control over financial reporting occurred during the quarter ended September 30, 2023[124](index=124&type=chunk) - Management acknowledges that all control systems have inherent limitations, providing reasonable rather than absolute assurance, and cannot prevent all errors and fraud[125](index=125&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company may be involved in legal proceedings, but currently believes the aggregate reasonably possible losses beyond established reserves will not materially impact consolidated financial condition or cash flows, though losses could significantly affect operating results in any specific future period - The company may be involved in legal proceedings from time to time, but currently believes the aggregate reasonably possible losses beyond established reserves will not materially impact consolidated financial condition or cash flows[127](index=127&type=chunk) - Nevertheless, losses could materially affect operating results for any particular future period, depending on the level of income for that period[127](index=127&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) As of the report date, there have been no material changes to the risk factors disclosed in the company's Form 10-K annual report filed on December 31, 2022 - As of the date of this report, there have been no material changes to the risk factors disclosed in the company's Form 10-K annual report filed on December 31, 2022[128](index=128&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the reporting period, the company had no unregistered sales of equity securities or use of proceeds - During the reporting period, the company had no unregistered sales of equity securities or use of proceeds[129](index=129&type=chunk) [Item 3. Defaults Upon Senior Securities](index=23&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) During the reporting period, the company had no defaults upon senior securities - During the reporting period, the company had no defaults upon senior securities[130](index=130&type=chunk) [Item 4. Mine Safety Disclosures](index=23&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable - Mine safety disclosures are not applicable to this section[131](index=131&type=chunk) [Item 5. Other Information](index=23&type=section&id=Item%205.%20Other%20Information) During the quarter, no directors or officers adopted or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements - During the quarter covered by this report, no directors or officers adopted or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements[132](index=132&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with this quarterly report, including articles of incorporation, certification documents, and XBRL data files - Exhibits include articles of incorporation, amended bylaws, certifications of the Chief Executive Officer and Chief Financial Officer (pursuant to Exchange Act Rule 13a-14(a) and 18 U.S.C. Section 1350), and Inline XBRL instance and taxonomy extension files[134](index=134&type=chunk) [SIGNATURES](index=25&type=section&id=SIGNATURES) This quarterly report was formally signed on November 14, 2023, by Kathy Lee-Sepsick, Chief Executive Officer and President, and Dov Elefant, Chief Financial Officer, of Femasys Inc. - This registration statement was signed on November 14, 2023, by Kathy Lee-Sepsick, Chief Executive Officer and President, and Dov Elefant, Chief Financial Officer, of Femasys Inc.[135](index=135&type=chunk)[136](index=136&type=chunk)

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q%20Filing%20Information) Details the company's quarterly report filing, including registrant information, filer status, and securities outstanding - Registrant: Femasys Inc., incorporated in Delaware, headquartered in Suwanee, GA[2](index=2&type=chunk)[3](index=3&type=chunk) - Filing Type: Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the period ended **June 30, 2023**[2](index=2&type=chunk) - Filer Status: Non-accelerated filer, Smaller reporting company, Emerging growth company[3](index=3&type=chunk)[4](index=4&type=chunk) Securities Registered | Title of each class | Trading symbol | Name of each exchange on which registered | |---|---|---| | Common stock, $0.001 par value | FEMY | The Nasdaq Capital Market | - Shares Outstanding: **15,073,153** shares of common stock as of **August 9, 2023**[4](index=4&type=chunk) [Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions readers about forward-looking statements, highlighting inherent risks and the company's policy against public updates - Forward-looking statements are identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or similar expressions[9](index=9&type=chunk) - Key areas covered by forward-looking statements include product development, clinical trials, regulatory approvals (FDA), financing, market competition, commercialization, reimbursement, manufacturing, and intellectual property[10](index=10&type=chunk) - Readers are cautioned that these statements are predictions based on current expectations and are subject to risks and uncertainties, including those detailed in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations'[11](index=11&type=chunk) - The company does not plan to publicly update or revise any forward-looking statements, and they are excluded from the safe harbor protection of the Private Securities Litigation Reform Act of 1995[11](index=11&type=chunk) [Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) This part presents the company's unaudited interim financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=5&type=section&id=Item%201%20Financial%20Statements) This section presents the unaudited interim financial statements of Femasys Inc. for the periods ended June 30, 2023, and December 31, 2022, including Balance Sheets, Statements of Comprehensive Loss, Stockholders' Equity, and Cash Flows, along with detailed accompanying notes. These statements provide a snapshot of the company's financial position, performance, and cash flows, highlighting ongoing losses and liquidity challenges [Balance Sheets](index=5&type=section&id=Balance%20Sheets%20as%20of%20June%2030%2C%202023%20and%20December%2031%2C%202022%20(unaudited)) Presents the company's financial position, detailing assets, liabilities, and equity for the reported periods Key Balance Sheet Data | Metric | June 30, 2023 | December 31, 2022 | |---|---|---| | Cash and cash equivalents | $10,705,017 | $12,961,936 | | Total current assets | $12,030,065 | $14,131,491 | | Total assets | $14,313,961 | $16,895,570 | | Total current liabilities | $1,381,543 | $1,527,809 | | Total liabilities | $1,437,788 | $1,653,051 | | Total stockholders' equity | $12,876,173 | $15,242,519 | | Accumulated deficit | $(99,974,270) | $(94,134,505) | - Cash and cash equivalents decreased by **$2,256,919** from **December 31, 2022**, to **June 30, 2023**[15](index=15&type=chunk) - Total assets decreased by **$2,581,609**, and total stockholders' equity decreased by **$2,366,346** during the six-month period[15](index=15&type=chunk)[17](index=17&type=chunk) - Accumulated deficit increased by **$5,839,765**, reflecting the net loss for the period[17](index=17&type=chunk) [Statements of Comprehensive Loss](index=7&type=section&id=Statements%20of%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022%20(unaudited)) Details the company's revenues, expenses, and net loss for the three and six months ended June 30 Comprehensive Loss (Three Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $320,514 | $303,113 | $17,401 | 5.7% | | Gross margin | $210,045 | $200,760 | $9,285 | 4.6% | | Total operating expenses | $3,146,007 | $2,860,723 | $285,284 | 10.0% | | Net loss | $(2,893,508) | $(2,634,101) | $(259,407) | 9.8% | | Net loss per share (basic & diluted) | $(0.22) | $(0.22) | $0.00 | 0.0% | Comprehensive Loss (Six Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $614,498 | $624,518 | $(10,020) | -1.6% | | Gross margin | $398,909 | $399,490 | $(581) | -0.1% | | Total operating expenses | $6,376,545 | $5,942,203 | $434,342 | 7.3% | | Net loss | $(5,839,765) | $(5,517,131) | $(322,634) | 5.8% | | Net loss per share (basic & diluted) | $(0.47) | $(0.47) | $0.00 | 0.0% | - Sales and marketing expenses significantly increased by **104%** for the three months and **183.1%** for the six months ended **June 30, 2023**, reflecting increased commercial efforts[20](index=20&type=chunk) - Interest income saw a substantial increase, rising by **59.5%** for the three months and **378.6%** for the six months ended **June 30, 2023**[20](index=20&type=chunk) [Statements of Stockholders' Equity](index=8&type=section&id=Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022%20(unaudited)) Outlines changes in stockholders' equity, including net loss, stock issuances, and share-based compensation, for the reported periods Stockholders' Equity Changes (Six Months Ended June 30, 2023) | Item | Amount | |---|---| | Balance at December 31, 2022 | $15,242,519 | | Issuance of common stock and warrants (April 2023 Financing) | $3,345,996 | | Exercise of pre-funded warrants | $188 | | Share-based compensation expense | $122,170 | | Net loss | $(5,839,765) | | Balance at June 30, 2023 | $12,876,173 | - Total stockholders' equity decreased from **$15,242,519** at **December 31, 2022**, to **$12,876,173** at **June 30, 2023**[23](index=23&type=chunk) - The **April 2023** Financing resulted in the issuance of **1,318,000** shares of common stock and warrants, contributing **$3,345,996** to equity[23](index=23&type=chunk) - Accumulated deficit increased by **$5,839,765** due to the net loss for the six months ended **June 30, 2023**[23](index=23&type=chunk) [Statements of Cash Flows](index=10&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022%20(unaudited)) Summarizes cash flows from operating, investing, and financing activities for the six months ended June 30 Cash Flow Summary (Six Months Ended June 30) | Activity | 2023 | 2022 | |---|---|---| | Net cash used in operating activities | $(5,388,824) | $(5,133,896) | | Net cash used in investing activities | $(71,849) | $(295,058) | | Net cash provided by (used in) financing activities | $3,203,754 | $(237,656) | | Net change in cash and cash equivalents | $(2,256,919) | $(5,666,610) | | Cash and cash equivalents, end of period | $10,705,017 | $19,116,419 | - Cash used in operating activities increased to **$5,388,824** in 2023 from **$5,133,896** in 2022, mainly due to the net loss[29](index=29&type=chunk) - Financing activities provided **$3,203,754** in 2023, a significant improvement from cash used of **$237,656** in 2022, primarily due to proceeds from the **April 2023** financing (**$3,899,813** gross)[29](index=29&type=chunk) - Purchases of property and equipment decreased significantly from **$295,058** in 2022 to **$71,849** in 2023[29](index=29&type=chunk) [Notes to Financial Statements](index=11&type=section&id=Notes%20to%20Financial%20Statements%20(unaudited)) Provides detailed explanations and additional information supporting the unaudited interim financial statements [Note 1: Organization, Nature of Business, and Liquidity](index=11&type=section&id=(1)%20Organization%2C%20Nature%20of%20Business%2C%20and%20Liquidity) Describes Femasys Inc.'s business, product candidates, and assesses its liquidity and going concern status - Femasys is a biomedical company focused on women's reproductive health, developing minimally invasive, in-office technologies for permanent birth control (FemBloc) and infertility (FemaSeed)[32](index=32&type=chunk)[33](index=33&type=chunk) - Key product candidates include FemBloc (FDA IDE approved for pivotal trial in **June 2023**), FemaSeed (FDA IDE approved, trial ongoing, approved for sale in Canada), FemVue (approved in U.S., Japan, Canada), FemChec, FemCath (approved in U.S., Canada), and FemCerv (approved in U.S., Canada)[33](index=33&type=chunk) - The company had **$10,705,017** in cash and cash equivalents as of **June 30, 2023**, and an accumulated deficit of **$99,974,270**[37](index=37&type=chunk)[41](index=41&type=chunk) - Femasys expects to incur additional losses and negative operating cash flows for at least the next **twelve months**, leading to substantial doubt about its ability to continue as a going concern[38](index=38&type=chunk)[41](index=41&type=chunk) - The company plans to finance operations through existing cash, additional equity/debt financing, and revenue from FemVue sales, but there's no assurance of obtaining sufficient funds[37](index=37&type=chunk) [Note 2: Cash and Cash Equivalents](index=12&type=section&id=(2)%20Cash%20and%20Cash%20Equivalents) Details the composition of cash and cash equivalents, primarily money market funds, and their fair value classification Money Market Funds in Cash and Cash Equivalents | Date | Amount | |---|---| | June 30, 2023 | $10,038,944 | | December 31, 2022 | $12,553,557 | - Money market funds represent **Level 1** within the fair value hierarchy, indicating quoted prices in active markets for identical assets[44](index=44&type=chunk) [Note 3: Inventories](index=12&type=section&id=(3)%20Inventories) Provides a breakdown of inventory components and the reserve for slow-moving or obsolete items Inventory Composition (Net of Reserve) | Category | June 30, 2023 | December 31, 2022 | |---|---|---| | Materials | $356,274 | $244,498 | | Work in progress | $71,081 | $100,453 | | Finished goods | $154,119 | $91,772 | | Total Inventory, net | $581,474 | $436,723 | - The reserve for slow-moving, obsolete, or unusable FemVue inventories increased from **$2,103** at **December 31, 2022**, to **$3,091** at **June 30, 2023**[45](index=45&type=chunk) [Note 4: Accrued Expenses](index=12&type=section&id=(4)%20Accrued%20Expenses) Details the composition of accrued expenses, including clinical trial costs, compensation, and director fees Accrued Expenses Composition | Category | June 30, 2023 | December 31, 2022 | |---|---|---| | Clinical trial costs | $295,582 | $333,440 | | Compensation costs | $129,323 | $85,191 | | Director fees | $90,424 | $0 | | Total Accrued expenses | $536,830 | $456,714 | - Director fees accrued significantly increased from **$0** to **$90,424**[46](index=46&type=chunk) [Note 5: Clinical Holdback](index=13&type=section&id=(5)%20Clinical%20Holdback) Outlines the activity and classification of the clinical holdback liability Clinical Holdback Liability Activity | Item | Amount | |---|---| | Balance at December 31, 2022 | $141,864 | | Clinical holdback retained | $3,447 | | Clinical holdback paid | $(328) | | Balance at June 30, 2023 | $144,983 | | Current portion | $(88,738) | | Long-term portion | $56,245 | [Note 6: Revenue Recognition](index=13&type=section&id=(6)%20Revenue%20Recognition) Explains the company's revenue recognition policies and presents sales data by geographic region - Revenue is recognized upon shipment of goods, with standard payment terms of **30 to 60** days, and no revenue is recognized over time[49](index=49&type=chunk) - The company has not had a history of significant returns[50](index=50&type=chunk) Sales by Geographic Region (Three Months Ended June 30) | Region | 2023 | 2022 | |---|---|---| | U.S. | $262,469 | $303,113 | | International | $58,045 | $0 | | Total | $320,514 | $303,113 | Sales by Geographic Region (Six Months Ended June 30) | Region | 2023 | 2022 | |---|---|---| | U.S. | $556,453 | $566,473 | | International | $58,045 | $58,045 | | Total | $614,498 | $624,518 | [Note 7: Commitments and Contingencies](index=13&type=section&id=(7)%20Commitments%20and%20Contingencies) Addresses potential legal contingencies and indemnification obligations for officers and directors - No material legal contingencies required accrual or disclosure for the periods presented[52](index=52&type=chunk) - The company indemnifies its officers and directors, with the maximum potential future indemnification being unlimited, but exposure is limited by director and officer insurance[53](index=53&type=chunk) [Note 8: Notes Payable](index=13&type=section&id=(8)%20Notes%20Payable) Details the principal balance and interest expense related to AFCO promissory notes AFCO Promissory Notes Principal Balance | Date | Principal Balance | |---|---| | June 30, 2023 | $0 | | December 31, 2022 | $141,298 | Interest Expense on AFCO Notes | Period | 2023 | 2022 | |---|---|---| | Three Months Ended June 30 | $1,319 | $86 | | Six Months Ended June 30 | $1,319 | $1,882 | [Note 9: Stockholders' Equity](index=14&type=section&id=(9)%20Stockholders'%20Equity) Describes significant changes in stockholders' equity, including recent financing activities and outstanding shares - In **April 2023**, the company completed a registered direct offering and concurrent private placement, selling **1,318,000** shares of common stock and pre-funded warrants for **1,878,722** shares, along with common warrants for **3,196,722** shares[58](index=58&type=chunk) - The **April 2023** Financing generated gross proceeds of **$3,899,813**, with net proceeds of **$3,352,049** after fees and expenses[58](index=58&type=chunk) - The at-the-market facility with Piper Sandler & Co. was suspended in **April 2023**, after selling **2,869** shares for the six months ended **June 30, 2023**[57](index=57&type=chunk) - As of **June 30, 2023**, **15,073,153** shares of common stock were outstanding, and no dividends have been declared or paid[59](index=59&type=chunk) [Note 10: Equity Incentive Plans and Warrants](index=14&type=section&id=(10)%20Equity%20Incentive%20Plans%20and%20Warrants) Provides details on stock option activity, share-based compensation, and outstanding warrants Stock Option Activity (Six Months Ended June 30, 2023) | Item | Number of options | Weighted average exercise price | |---|---|---| | Outstanding at December 31, 2022 | 931,550 | $3.97 | | Granted | 158,200 | $0.80 (avg) | | Forfeited | (70,079) | $2.40 (avg) | | Outstanding at June 30, 2023 | 1,019,671 | $3.57 | | Vested and exercisable at June 30, 2023 | 511,472 | $3.09 | Share-Based Compensation Expense (Six Months Ended June 30) | Category | 2023 | 2022 | |---|---|---| | Research and development | $52,251 | $62,575 | | Sales and marketing | $(1,942) | $2,342 | | General and administrative | $71,861 | $41,609 | | Total share-based compensation expense | $122,170 | $106,526 | - All pre-funded warrants issued in the **April 2023** financing were exercised for common stock in **June 2023**[70](index=70&type=chunk) - As of **June 30, 2023**, common warrants and placement agent warrants from the **April 2023** financing remained outstanding[70](index=70&type=chunk) [Note 11: Net Loss per Share Attributable to Common Stockholders](index=16&type=section&id=(11)%20Net%20Loss%20per%20Share%20Attributable%20to%20Common%20Stockholders) Presents basic and diluted net loss per share and weighted average shares outstanding for the reported periods Net Loss per Share (Basic & Diluted) | Period | 2023 | 2022 | |---|---|---| | Three Months Ended June 30 | $(0.22) | $(0.22) | | Six Months Ended June 30 | $(0.47) | $(0.47) | Weighted Average Shares Outstanding | Period | 2023 | 2022 | |---|---|---| | Three Months Ended June 30 | 13,107,590 | 11,812,988 | | Six Months Ended June 30 | 12,493,334 | 11,808,601 | - Potentially dilutive securities, including options and warrants, were excluded from diluted EPS calculations because they were anti-dilutive[73](index=73&type=chunk) [Note 12: Subsequent Events](index=16&type=section&id=(12)%20Subsequent%20Events) Reports significant events occurring after the balance sheet date, including new financing and lease extensions - On **July 11, 2023**, the company executed a promissory note with AFCO for **$420,618** to finance insurance premiums[74](index=74&type=chunk) - On **July 17, 2023**, the operating lease for facilities in Suwanee, GA, was extended for an additional **63 months** through **April 2029**, obligating the company to **$3,321,025** in payments[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&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, results of operations, and liquidity for the periods presented. It highlights product development progress, recent corporate and clinical updates, and a detailed analysis of revenue, expenses, and cash flows, emphasizing the company's ongoing net losses and need for additional financing to support its biomedical product pipeline [Overview](index=17&type=section&id=Overview) Provides a high-level introduction to Femasys Inc.'s business, product development, and intellectual property portfolio - Femasys is a biomedical company developing minimally invasive, in-office technologies for reproductive health, with an expansive intellectual property portfolio of over **150** global patents[78](index=78&type=chunk) - The company's lead product candidates are FemBloc for permanent birth control and FemaSeed for artificial insemination infertility treatment, targeting multi-billion dollar markets with little prior advancement[78](index=78&type=chunk) [Corporate Update](index=17&type=section&id=Corporate%20Update) Highlights recent corporate milestones, including product approvals and patent allowances - **April 18, 2023**: Health Canada granted product approval for FemaSeed, an artificial insemination solution[79](index=79&type=chunk) - **May 3, 2023**: Health Canada granted product approval for FemCerv, an endocervical tissue sampler[80](index=80&type=chunk) - **June 8, 2023**: Health Canada granted product approval for FemCath, an intrauterine catheter[81](index=81&type=chunk) - **June 26, 2023**: FDA approved the Investigational Device Exemption (IDE) for FemBloc's pivotal clinical trial for permanent birth control[81](index=81&type=chunk) - **July 27, 2023**: Notice of allowance for a new U.S. patent application covering FemBloc for female permanent birth control[82](index=82&type=chunk) - **August 3, 2023**: Initiation of enrollment in FemBloc's pivotal trial[83](index=83&type=chunk) [Clinical Update](index=17&type=section&id=Clinical%20Update) Details the progress and design of key clinical trials for FemaSeed and FemBloc - FemaSeed pivotal trial: Updated design focuses on male factor infertility to accelerate enrollment, with completion expected in **Q4 2023** and FDA submission planned thereafter[84](index=84&type=chunk) - FemaSeed enrollment slowdowns are attributed to consolidation activities, staffing shortages at clinical trial sites, and uncertainty surrounding abortion policy proposals affecting reproductive medicine[84](index=84&type=chunk) - FemBloc pivotal FINALE trial: FDA IDE approval received in **June 2023**, and enrollment initiated in **August 2023**[86](index=86&type=chunk) - FemBloc trial design: Prospective, multi-center, open-label, single-arm study with pregnancy rate as the primary endpoint, targeting **401** women for one year of use, with an interim analysis planned after **300** women[86](index=86&type=chunk) - A new U.S. patent for FemBloc, expected to expire in **2039**, received a notice of allowance in **July 2023**[86](index=86&type=chunk) [Results of Operations - Three Months Ended June 30, 2023 and 2022](index=18&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202023%20and%202022) Compares the company's financial performance, including sales, expenses, and net loss, for the three months ended June 30 Financial Performance (Three Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $320,514 | $303,113 | $17,401 | 5.7% | | Cost of sales | $110,469 | $102,353 | $8,116 | 7.9% | | Gross margin | $210,045 | $200,760 | $9,285 | 4.6% | | Total operating expenses | $3,146,007 | $2,860,723 | $285,284 | 10.0% | | Net loss | $(2,893,508) | $(2,634,101) | $(259,407) | 9.8% | - Sales increase was primarily due to **$58,045** in international sales in 2023, with no international sales in the prior year, while U.S. sales decreased by **13.4%**[87](index=87&type=chunk) - Sales and marketing expenses more than doubled, increasing by **104%** to **$128,899**, reflecting increased commercial efforts[90](index=90&type=chunk) - Research and development expenses increased by **3.7%** to **$1,527,172**, mainly due to higher compensation and professional costs[89](index=89&type=chunk) [Results of Operations - Six Months Ended June 30, 2023 and 2022](index=19&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) Compares the company's financial performance, including sales, expenses, and net loss, for the six months ended June 30 Financial Performance (Six Months Ended June 30) | Metric | 2023 | 2022 | Change | % Change | |---|---|---|---|---| | Sales | $614,498 | $624,518 | $(10,020) | -1.6% | | Cost of sales | $215,589 | $225,028 | $(9,439) | -4.2% | | Gross margin | $398,909 | $399,490 | $(581) | -0.1% | | Total operating expenses | $6,376,545 | $5,942,203 | $434,342 | 7.3% | | Net loss | $(5,839,765) | $(5,517,131) | $(322,634) | 5.8% | - Sales decrease was entirely attributable to U.S. sales, with international sales remaining consistent[95](index=95&type=chunk) - Gross margin percentage improved to **64.9%** from **64.0%** due to manufacturing efficiencies[96](index=96&type=chunk) - Sales and marketing expenses surged by **183.1%** to **$373,795**, primarily due to increased compensation and marketing costs[98](index=98&type=chunk) - Interest income increased significantly by **378.6%** to **$139,741**[101](index=101&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, funding needs, and ability to continue as a going concern - As of **June 30, 2023**, the company had **$10,705,017** in cash and cash equivalents and an accumulated deficit of **$99,974,270**[103](index=103&type=chunk) - Existing cash and net proceeds from the **April 2023** financing (**$3,352,049**) are expected to fund operations into the **second quarter of 2024**[105](index=105&type=chunk)[106](index=106&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern for at least **twelve months** from the financial statement date[106](index=106&type=chunk) - Additional capital is required to complete development and commercialization of product candidates, with no assurance of securing funds on acceptable terms[107](index=107&type=chunk) [Cash Flows](index=21&type=section&id=Cash%20Flows) Analyzes cash flows from operating, investing, and financing activities for the six months ended June 30 Cash Flow Summary (Six Months Ended June 30) | Activity | 2023 | 2022 | |---|---|---| | Net cash used in operating activities | $(5,388,824) | $(5,133,896) | | Net cash used in investing activities | $(71,849) | $(295,058) | | Net cash provided by (used in) financing activities | $3,203,754 | $(237,656) | | Net change in cash and cash equivalents | $(2,256,919) | $(5,666,610) | - Operating activities used **$5,388,824** in cash, mainly due to the net loss, partially offset by non-cash charges like depreciation and stock-based compensation[109](index=109&type=chunk) - Financing activities provided **$3,203,754**, primarily from the issuance of common stock and warrants (**$3,905,071**), offset by offering costs and note repayments[113](index=113&type=chunk) - Investing activities used **$71,849** for property and equipment purchases, a decrease from **$295,058** in the prior year[111](index=111&type=chunk)[112](index=112&type=chunk) [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) Explains key accounting policies and estimates, particularly for revenue recognition and accrued expenses - Revenue recognition policy: Revenue is recognized when a customer obtains control of promised goods, typically upon shipment, with no multiple performance obligations or revenue recognized over time[117](index=117&type=chunk) - Accrued expenses policy: Estimates are made for R&D activities conducted by third-party service providers, recording costs based on estimated services provided but not yet invoiced, which can be a significant component of R&D expenses[119](index=119&type=chunk) - Estimates are based on historical experience and other reasonable factors, but actual results may differ materially[115](index=115&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no applicable quantitative and qualitative disclosures about market risk for Femasys Inc. for the reported period - The company has no applicable quantitative and qualitative disclosures about market risk[120](index=120&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of Femasys Inc.'s disclosure controls and procedures as of June 30, 2023, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting were identified, though inherent limitations on control effectiveness are acknowledged - Disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of **June 30, 2023**[121](index=121&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended **June 30, 2023**[122](index=122&type=chunk) - Management acknowledges inherent limitations of control systems, stating they provide only reasonable, not absolute, assurance against errors and fraud[123](index=123&type=chunk) [Part II. Other Information](index=23&type=section&id=Part%20II.%20Other%20Information) This part contains additional information not covered in the financial statements, including legal proceedings and risk factors [Item 1. Legal Proceedings](index=23&type=section&id=Item%201%20Legal%20Proceedings) Femasys Inc. may be involved in legal proceedings but believes that the amount of reasonably possible losses in excess of established reserves is not material to its consolidated financial condition or cash flows, although such losses could be material to operating results for a specific future period - The company believes that reasonably possible losses from pending legal actions, in excess of reserves, are not material to its consolidated financial condition or cash flows[125](index=125&type=chunk) - Losses from legal proceedings could be material to operating results for any particular future period[125](index=125&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A%20Risk%20Factors) This section refers readers to the comprehensive risk factors detailed in the company's Annual Report on Form 10-K. A new risk factor highlights Femasys Inc.'s non-compliance with Nasdaq's minimum bid price requirement, which could lead to delisting and negatively impact stock liquidity and future capital raising abilities - Readers are directed to the Annual Report on Form 10-K for a comprehensive review of risk factors[126](index=126&type=chunk) - The company received a deficiency letter from Nasdaq on **June 1, 2023**, for non-compliance with the Minimum Bid Price Requirement (**$1.00** per share)[127](index=127&type=chunk) - Femasys has until **November 28, 2023**, to regain compliance, potentially through a reverse stock split, or face delisting, which could reduce stock liquidity and harm capital raising[127](index=127&type=chunk)[128](index=128&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&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 or use of proceeds to report for Femasys Inc. during the period - No unregistered sales of equity securities or use of proceeds to report[129](index=129&type=chunk) [Item 3. Defaults Upon Senior Securities](index=24&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) This section indicates that Femasys Inc. has no defaults upon senior securities to report for the period - No defaults upon senior securities to report[131](index=131&type=chunk) [Item 4. Mine Safety Disclosures](index=24&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[132](index=132&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205%20Other%20Information) This section indicates that there is no other information to report for Femasys Inc. for the period - No other information to report[133](index=133&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed as part of Femasys Inc.'s Form 10-Q, including various warrants, a securities purchase agreement, and certifications from the principal executive and financial officers, providing supporting documentation for the report - Exhibits include Pre-Funded Common Stock Purchase Warrant, Common Stock Purchase Warrant, Placement Agent Common Stock Purchase Warrant, and Securities Purchase Agreement dated **April 18, 2023**[134](index=134&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act are filed herewith[134](index=134&type=chunk) [Signatures](index=25&type=section&id=SIGNATURES) Confirms the official signing of the Form 10-Q report by the company's principal executive and financial officers - The report is signed by Kathy Lee-Sepsick, Chief Executive Officer and President, and Dov Elefant, Chief Financial Officer, on **August 10, 2023**[135](index=135&type=chunk)[137](index=137&type=chunk)

TABLE OF CONTENTS Femasys Inc. (Exact name of registrant as specified in its charter) As filed with the Securities and Exchange Commission on July 7, 2023 Registration No. 333-272876 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Delaware 3841 11-3713499 of incorporation or organization) Classification Code Number) Identification No.) (State or jurisdiction (Primary Standard Industrial (I.R.S. Employ ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on June 23, 2023 Registration No. 333- (State or jurisdiction (Primary Standard Industrial (I.R.S. Employer 3950 Johns Creek Court, Suite 100 Suwanee, Georgia 30024 (770) 500-3910 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Kathy Lee-Sepsick President and Chief Executive Officer 3950 Johns Creek Court, Suite 100 Suwanee, Georgia 30024 (770) 500-3910 (Name, address, ...