Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 08, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Transition Report | false | |
Entity File Number | 001-40492 | |
Entity Registrant Name | Femasys Inc. | |
Entity Central Index Key | 0001339005 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 11-3713499 | |
Entity Address, Address Line One | 3950 Johns Creek Court | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Suwanee | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30024 | |
City Area Code | 770 | |
Local Phone Number | 500-3910 | |
Title of 12(b) Security | Common stock, $0.001 par value | |
Trading Symbol | FEMY | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 22,220,718 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 17,835,968 | $ 21,716,077 |
Accounts receivable, net | 120,529 | 98,906 |
Inventory, net | 971,297 | 667,118 |
Prepaid and other current assets | 955,539 | 695,879 |
Total current assets | 19,883,333 | 23,177,980 |
Property and equipment, at cost: | ||
Leasehold improvements | 1,212,417 | 1,212,417 |
Office equipment | 47,308 | 47,308 |
Furniture and fixtures | 417,654 | 414,303 |
Machinery and equipment | 2,582,220 | 2,559,356 |
Construction in progress | 569,723 | 423,077 |
Property and equipment, gross | 4,829,322 | 4,656,461 |
Less accumulated depreciation | (3,615,405) | (3,545,422) |
Net property and equipment | 1,213,917 | 1,111,039 |
Long-term assets: | ||
Lease right-of-use assets, net | 2,227,561 | 2,380,225 |
Intangible assets, net of accumulated amortization | 33,115 | 0 |
Other long-term assets | 1,013,034 | 1,086,581 |
Total long-term assets | 3,273,710 | 3,466,806 |
Total assets | 24,370,960 | 27,755,825 |
Current liabilities: | ||
Accounts payable | 1,095,730 | 1,137,823 |
Accrued expenses | 673,457 | 1,444,296 |
Clinical holdback - current portion | 93,376 | 65,300 |
Lease liabilities - current portion | 494,967 | 406,636 |
Total current liabilities | 2,357,530 | 3,054,055 |
Long-term liabilities: | ||
Clinical holdback - long-term portion | 30,389 | 54,935 |
Convertible notes payable, net (including related parties) | 4,472,456 | 4,258,179 |
Lease liabilities - long-term portion | 1,902,991 | 2,036,067 |
Total long-term liabilities | 6,405,836 | 6,349,181 |
Total liabilities | 8,763,366 | 9,403,236 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $.001 par, 200,000,000 authorized, 22,216,570 shares issued and 22,099,347 outstanding as of March 31, 2024; and 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023 | 22,217 | 21,775 |
Treasury stock, 117,223 common shares | (60,000) | (60,000) |
Warrants | 2,631,838 | 2,787,137 |
Additional paid-in-capital | 124,994,678 | 123,985,306 |
Accumulated deficit | (111,981,139) | (108,381,629) |
Total stockholders' equity | 15,607,594 | 18,352,589 |
Total liabilities and stockholders' equity | $ 24,370,960 | $ 27,755,825 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Stockholders' equity: | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, issued (in shares) | 22,216,570 | 21,774,604 |
Common stock, outstanding (in shares) | 22,099,347 | 21,657,381 |
Treasury stock, common shares (in shares) | 117,223 | 117,223 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Statements of Comprehensive Loss [Abstract] | ||
Sales | $ 271,140 | $ 293,984 |
Cost of sales (excluding depreciation expense) | 88,532 | 105,120 |
Operating expenses: | ||
Research and development | 1,770,731 | 1,537,439 |
Sales and marketing | 300,487 | 244,896 |
General and administrative | 1,502,804 | 1,315,137 |
Depreciation and amortization | 71,228 | 133,066 |
Total operating expenses | 3,645,250 | 3,230,538 |
Loss from operations | (3,462,642) | (3,041,674) |
Other income (expense): | ||
Interest income | 224,684 | 97,089 |
Interest expense | (361,552) | (1,672) |
Total other income (expense) | (136,868) | 95,417 |
Net loss | (3,599,510) | (2,946,257) |
Net loss attributable to common stockholders, basic | (3,599,510) | (2,946,257) |
Net loss attributable to common stockholders, diluted | $ (3,599,510) | $ (2,946,257) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.17) | $ (0.25) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.17) | $ (0.25) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 21,775,357 | 11,872,255 |
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 21,775,357 | 11,872,255 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Treasury Common Stock [Member] | Warrants [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2022 | $ 11,987 | $ (60,000) | $ 567,972 | $ 108,857,065 | $ (94,134,505) | $ 15,242,519 |
Balance (in shares) at Dec. 31, 2022 | 11,986,927 | |||||
Treasury stock, common shares (in shares) at Dec. 31, 2022 | 117,223 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs | $ 3 | $ 0 | 0 | 3,365 | 0 | 3,368 |
Issuance of common stock in connection with at-the-market offering, net of issuance costs (in shares) | 2,869 | 0 | ||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 56,954 | 0 | 56,954 |
Net loss | 0 | $ 0 | 0 | 0 | (2,946,257) | (2,946,257) |
Treasury stock, common shares (in shares) at Mar. 31, 2023 | 117,223 | |||||
Balance at Mar. 31, 2023 | $ 11,990 | $ (60,000) | 567,972 | 108,917,384 | (97,080,762) | 12,356,584 |
Balance (in shares) at Mar. 31, 2023 | 11,989,796 | |||||
Balance at Dec. 31, 2023 | $ 21,775 | $ (60,000) | 2,787,137 | 123,985,306 | (108,381,629) | $ 18,352,589 |
Balance (in shares) at Dec. 31, 2023 | 21,774,604 | 21,774,604 | ||||
Treasury stock, common shares (in shares) at Dec. 31, 2023 | 117,223 | 117,223 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs | $ 442 | $ 0 | 0 | 776,488 | 0 | $ 776,930 |
Issuance of common stock in connection with at-the-market offering, net of issuance costs (in shares) | 441,966 | 0 | ||||
Expiration of Warrant | (155,299) | 155,299 | ||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 77,585 | 0 | 77,585 |
Net loss | 0 | $ 0 | 0 | 0 | (3,599,510) | $ (3,599,510) |
Treasury stock, common shares (in shares) at Mar. 31, 2024 | 117,223 | 117,223 | ||||
Balance at Mar. 31, 2024 | $ 22,217 | $ (60,000) | $ 2,631,838 | $ 124,994,678 | $ (111,981,139) | $ 15,607,594 |
Balance (in shares) at Mar. 31, 2024 | 22,216,570 | 22,216,570 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | |
Cash flows from operating activities: | |||
Net loss | $ (3,599,510) | $ (2,946,257) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 69,983 | 131,653 | |
Amortization | 1,245 | 1,413 | |
Amortization of right-of-use assets | 152,664 | 75,635 | |
Provision for bad debts | 1,000 | 0 | |
Inventory reserve write-off | 1,240 | 300 | |
Share-based compensation expense | 77,585 | 56,954 | |
Amortization of debt issuance costs and discount | 258,802 | 0 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | (22,623) | (46,485) | |
Inventory | (305,419) | (64,318) | |
Prepaid and other assets | (187,359) | 150,654 | |
Accounts payable | (137,753) | 3,016 | |
Accrued expenses | (792,239) | 78,703 | |
Lease liabilities | (44,745) | (91,211) | |
Other liabilities | (40,995) | 2,306 | |
Net cash used in operating activities | (4,568,124) | (2,647,637) | |
Cash flows from investing activities: | |||
Acquisition of patents | (25,603) | 0 | |
Purchases of property and equipment | (64,557) | (8,901) | |
Net cash used in investing activities | (90,160) | (8,901) | |
Cash flows from financing activities: | |||
Proceeds from at-the-market sales of common stock | 802,242 | 3,373 | $ 8,700,000 |
Issuance costs for at-the-market sales of common stock | (24,067) | 0 | |
Repayment of note payable | 0 | (141,298) | |
Payments under lease obligations | 0 | (6,135) | |
Net cash provided by (used in) financing activities | 778,175 | (144,060) | |
Net change in cash and cash equivalents | (3,880,109) | (2,800,598) | |
Cash and cash equivalents: | |||
Beginning of period | 21,716,077 | 12,961,936 | |
End of period | 17,835,968 | 10,161,338 | $ 17,835,968 |
Cash paid for: | |||
Interest | 0 | 1,672 | |
Non-cash investing and financing activities: | |||
Property and equipment costs included in accounts payable and accrued expense | 108,304 | 12,990 | |
Acquisition of patents included in accounts payable | 8,757 | ||
Commissions costs relating to certain proceeds from issuance of common stock | 0 | 109 | |
Deferred offering costs reclassified to additional paid-in-capital | $ 1,245 | $ 0 |
Organization, Nature of Busines
Organization, Nature of Business, and Liquidity | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Nature of Business, and Liquidity [Abstract] | |
Organization, Nature of Business, and Liquidity | (1) Organization, Nature of Business, and Liquidity Organization and Nature of Business Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a leading biomedical company focused on addressing significant unmet needs for women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, including a lead revolutionary product candidate and FDA-cleared products. The Company’s mission is to provide women with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics focused on servicing the reproductive health needs for those seeking solutions for infertility issues (FemaSeed® and FemVue®) or permanent birth control (FemBloc®). The Company currently operates a segment with an initial focus on servicing the reproductive health needs for those seeking solutions for infertility issues or permanent birth control. Femasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemaSeed, a solution which enables directed intratubal insemination to improve on traditional intrauterine insemination (IUI) and provides a lower cost and safer option to in vitro fertilization methods, received approval to sell FemaSeed in Canada in April 2023. In September 2023, the Company received 510(k) clearance from the FDA for FemaSeed for intratubal insemination to market in the United States. A pivotal clinical trial was still ongoing at the time of receiving regulatory clearance, however, enrollment was completed in November 2023. FemVue, a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S., Japan, and Canada. FemChec® allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success). FemCerv® is a solution for complete tissue sampling with minimal contamination of the endocervical canal in a virtually pain-free procedure as an alternative to the single biopsy method and is approved for sale in the U.S. and Canada. FemCath®, allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter that is undirected, is approved for sale in the U.S. and Canada. FemBloc ® Basis of Presentation The Company has prepared the accompanying condensed financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to these rules and regulations. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2023 included in our Annual Report on Form 10K filed with the SEC on March 28, 2024 (the Annual Report). There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in the Annual Report. In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows at the dates for periods presented. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expense during the reporting periods. Estimates for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates. Liquidity As of March 31, 2024, the Company had cash and cash equivalents of $17,835,968. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue primarily anticipated from the sale of FemVue and FemaSeed to support the Company’s research and development activities, largely in connection with FemBloc. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted. For the three months ended March 31, 2024, the Company generated a net loss of $3,599,510. The Company expects such losses to increase over the next few years as the Company advances FemBloc through clinical development until FDA approval is received and is available to be marketed. The Company believes that its cash and cash equivalents as of March 31, 2024 and cash received subsequent to quarter end (see Note 16 , Subsequent Events ) will be sufficient to fund our ongoing operations at least 12 months from the date of filing these condensed financial statements. Recently Issued Accounting Pronouncements – Recently Adopted I Segment Reporting (Topic 28): Improvements to Reportable Segment Disclosures Recently Issued Accounting Pronouncements – Not Yet Adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company’s annual reporting periods beginning after December 15, 2024. Adoption is either with a prospective method or a fully retrospective method of transition. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2023-09 will have on its financial statements and expects to adopt the ASU on January 1, 2025. No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s financial statements. |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value [Abstract] | |
Fair Value [Text Block] | (2) Fair Value The Company applies a fair value hierarchy that requires the use of observable market data, when available, and prioritizes the inputs to valuation techniques used to measure fair value in the following categories: Level 1 – Valuation is based upon quoted prices for identical instruments traded in active markets. Level 2 – Valuation is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑based valuation techniques for which all significant assumptions are observable in the market. Level 3 – Valuation is generated from model‑based techniques that use significant assumptions not observable in the market. These unobservable assumptions reflect the Company’s own estimates of assumptions market participants would use in pricing the asset or liability. Certain of the Company’s financial instruments, including cash and cash equivalents, notes payable and other liabilities approximate their fair value because of the short‑term maturity of these financial instruments and are based on Level 1 inputs. The Company’s equity-classified warrants and stock options are measured at fair value upon grant using the Black-Scholes option pricing model, a Level 2 input. The Company uses unobservable inputs for the model’s assumptions, including management’s assumptions of the Company’s volatility and price of the underlying stock. The fair value of the Company’s convertible notes is disclosed at each reporting period based on a discounted cash flow analysis, a Level 3 input. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 3 Months Ended |
Mar. 31, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | (3) Cash and Cash Equivalents As of March 31, 2024 and December 31, 2023, money market funds included in cash and cash equivalents on the balance sheets were $17,503,242 and $21,278,895, respectively, which represent level 1 within the fair value hierarchy where there are quoted prices in active markets for identical assets. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2024 | |
Inventories [Abstract] | |
Inventories | (4) Inventories Inventory stated at cost, net of reserve, consisted of the following: March 31, December 31, 2024 2023 Materials $ 574,199 367,934 Work in progress 131,657 128,993 Finished goods 265,441 170,191 Inventory, net $ 971,297 667,118 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | (5) Accrued Expenses Accrued expenses consisted of the following: March 31, December 31, 2024 2023 Clinical trial costs $ 243,367 276,141 Accrued interest 147,275 — Incentive and other compensation costs 146,409 1,082,606 Director fees 70,000 60,210 Franchise taxes 12,800 12,160 Other 53,606 13,179 Accrued expenses $ 673,457 1,444,296 |
Clinical Holdback
Clinical Holdback | 3 Months Ended |
Mar. 31, 2024 | |
Clinical Holdback [Abstract] | |
Clinical Holdback | (6) Clinical Holdback The following table shows the activity within the clinical holdback liability accounts for the three months ended March 31, 2024: Balance at December 31, 2023 $ 120,235 Clinical holdback retained 3,530 Clinical holdback paid — Balance at March 31, 2024 $ 123,765 Less: clinical holdback - current portion (93,376 ) Clinical holdback - long-term portion $ 30,389 |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2024 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | (7) Revenue Recognition Revenue is recognized upon shipment of our goods based upon contractually stated pricing at standard payment terms ranging from 30 to 60 days. All revenue is recognized point in time and no revenue is recognized over time. For the three months ended March 31, 2024 and 2023, there was no revenue recognized from performance obligations satisfied or partially satisfied in prior periods, nor were there any unsatisfied performance obligations as of March 31, 2024 or 2023. The majority of products sold directly to U.S customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to our international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in original unopened cartons and are subject to a 30% restocking fee. Throughout the periods presented, the Company has not had a history of significant returns. The following table summarizes our sales, primarily from FemVue, by geographic region as follows: Three Months Ended March 31, Primary geographical markets 2024 2023 U.S. $ 271,140 293,984 International — — Total $ 271,140 293,984 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | (8) Commitments and Contingencies Legal Claims Occasionally, the Company may be a party to legal claims or proceedings of which the outcomes are subject to significant uncertainty. In accordance with Accounting Standards Codification Contingencies The Company, as permitted under Delaware law and in accordance with its bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The Company entered into employment agreements with its officers, which provides for indemnification protection in the executive’s capacity as an officer for actions taken within the scope of employment. The maximum amount of potential future indemnification is unlimited; however, the Company has obtained director and officer insurance that limits its exposure. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of March 31, 2024 and December 31, 2023. |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2024 | |
Notes Payable [Abstract] | |
Notes Payable | (9) Notes Payable AFCO Credit Corporation (AFCO) In June 2022, the Company executed a Promissory Note with AFCO to finance certain insurance premiums totaling $465,380, requiring the Company to pay $47,539 in a down payment and make monthly installment payments. The annual interest rate was 5.7% and the monthly installment payment was $47,539, which represents principal and interest. The final installment payment was paid in March of 2023 In July 2023, the Company executed a Promissory Note with AFCO to finance certain insurance premiums totaling $469,042, requiring the Company to pay $48,423 in a down payment and make monthly installment payments. The annual interest rate was 8.6% and the monthly installment is $48,423, which represents principal and interest. The Promissory Note was paid in full without penalty in November 2023 As of March and December there was no principal balance on the AFCO note in the accompanying balance sheets. Interest expense in connection with the AFCO promissory notes was and for the months ended March and respectively. |
Convertible Notes with Warrants
Convertible Notes with Warrants (November 2023 Financing) | 3 Months Ended |
Mar. 31, 2024 | |
Convertible Notes with Warrants (November 2023 Financing) [Abstract] | |
Convertible Notes with Warrants (November 2023 Financing) | (10) Convertible Notes with Warrants (November 2023 Financing) On November 21, 2023, the Company issued (i) senior unsecured convertible notes in an aggregate principal amount of $6,850,000, convertible into shares of common stock at a conversion price of $1.18 per share, (ii) Series A Warrants to purchase up to an aggregate of 5,805,083 shares of common stock at an exercise price of $1.18 per share, and (iii) Series B Warrants, together with the Series A Warrants, and, together with the convertible notes, to purchase up to an aggregate of 5,805,083 shares of common stock at an exercise price of $1.475 per share. The financing resulted in aggregate gross proceeds of $6,850,000, before $525,144 of transaction costs. The Company intends to use the net proceeds from the offering for general corporate purposes. The Notes accrue interest at a rate of 6.0% per annum, payable annually, in cash or shares of common stock at the Company’s option, and mature on November 21, 2025, unless earlier converted or redeemed. The Notes are convertible into shares of common stock at the election of the holder at any time at an initial conversion price of $1.18. The Company has agreed not to issue or sell any equity securities of the Company at a price below the then-current conversion price for a period of 18 months after closing, subject to certain exceptions. Beginning six months after issuance, the Company may require holders to convert their Notes into conversion shares if the closing price of the common stock exceeds $2.36 per share for 10 consecutive trading days and the daily dollar trading volume of the common stock exceeds $1,000,000 per day during the same period and certain equity conditions described in the Notes are satisfied. The Notes provide for certain events of default, whereby each holder of Notes will be able to require the Company to redeem in cash any or all of the holder’s Notes at a premium of 115%. The conversion feature did not meet the requirements for separate accounting and is not accounted for as a derivative instrument. As of March 31, 2024, the Convertible Notes have not been converted into shares of common stock. The Warrants The Series A Warrants are exercisable immediately and expire five years from the date of issuance. The Company has the right to call the exercise of the Series A Warrants if the closing price of the common stock exceeds 200% of the Series A Exercise Price for 10 consecutive trading days and the daily dollar trading volume of the common stock exceeds $1,000,000 per day during the same period and certain equity conditions are satisfied. The Series B Warrants are exercisable immediately, together with the Series A Warrant Shares, and expire one year from the date of issuance. The Company has the right to call the exercise of the Series B Warrants if the closing price of the common stock exceeds 200% of the Series B exercise price for 10 consecutive trading days and the daily dollar trading volume of the common stock exceeds $1,000,000 per day during the same period and certain equity conditions are satisfied. There is no established public trading market for the warrants and the Company does not intend to list the Warrants on any national securities exchange or nationally recognized trading system. The Series A Warrants and Series B Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock from which they are issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. The Series A and Series B Warrants were valued using the relative fair value method and the following Black-Scholes assumptions: Series A Warrants Series B Warrants Expected term (in years) 5 1 Risk‑free interest rate 4.55 % 5.24 % Dividend yield — % — % Expected volatility 104.89 % 113.84 % Exercise price $ 1.18 $ 1.48 Stock price $ 0.95 $ 0.95 Black-Scholes value $ 0.55 $ 0.28 The November 2023 Financing proceeds of $6,850,000 net of $525,144 in transaction costs were allocated to the convertible notes and Series A and Series B Warrants using the relative fair value method. The valuation of the warrants was $2,219,165 and was recorded as a component of stockholders’ equity, and a total debt discount of $2,744,309. The convertible notes are recorded as a long-term liability, net of discount and issuance costs. For the convertible notes for the quarter ended March 31, 2024, the Company recognized total interest expense of $361,552, including coupon interest expense of $102,750 amortization of debt discount and issuance costs of $258,802. As of December 31, 2023, the Notes principal balance as $6,850,000, unamortized discount was $2,636,346 and accrued interest was $44,525. As of March 31, 2024, the Notes principal balance as $6,850,000, unamortized discount was $2,377,544 and accrued interest was $147,275. The fair value of the convertible notes on March 31, 2024, calculated using a discounted cash flow analysis, was $6,185,934. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | (11) Stockholders’ Equity On July 1, 2022, we filed a prospectus including an offering to sell up to $150 million in common and preferred stock, debt securities and warrants. Additionally, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler” or the “Sales Agent”) and filed a related prospectus establishing an “at-the-market” facility, pursuant to which we may offer and sell shares of our common stock from time to time through the Sales Agent. In October 2023, the Sales Agent was authorized to sell shares for aggregate proceeds up to $16.7 million at current market prices until all shares are sold. As of March 31, 2024, 3.9 million shares of common stock have been sold for aggregate proceeds of $8.7 million under the Equity Distribution Agreement pursuant to the prospectus. As of March 31, 2024, the amount we are authorized to sell is subject to baby-shelf limitations. In April 2023, the Company sold an aggregate of (i) 1,318,000 shares of common stock and (ii) pre-funded warrants to purchase up to 1,878,722 shares of common stock in a registered direct offering (“pre-funded warrants”) and, in a concurrent private placement, warrants to purchase up to 3,196,722 shares of common stock (“common warrants”). Additionally, common warrants were issued to the placement agent to purchase up to 191,803 shares of common stock as compensation for services (“placement agent warrants”), collectively the (“April 2023 Financing”). The purchase price per share for the common stock, pre-funded warrants was $1.22 and $1.2199, respectively. The gross proceeds from the offering were $3,899,813, less placement agent fees and offering expenses of $547,764. The Company intends to use the net proceeds from the offering for general corporate purposes. As of March 31, 2024, the Company had 22,099,347 shares of common stock outstanding, and no dividends have been declared or paid. |
Equity Incentive Plans and Warr
Equity Incentive Plans and Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Equity Incentive Plans and Warrants [Abstract] | |
Equity Incentive Plans and Warrants | (12) Equity Incentive Plans and Warrants Stock-Based Awards (a) Stock Option Plans Activity under the Company’s stock option plans for the three months ended March 31, 2024 was as follows: Number of options Weighted average exercise price Outstanding at December 31, 2023 2,102,030 $ 2.00 Granted 708,821 0.97 Forfeited (62,618 ) 2.59 Outstanding at March 31, 2024 2,748,233 $ 1.72 Vested and exercisable at March 31 1,208,627 $ 2.63 Options granted under our 2021 Stock Option Plan for the three months ended March 31, 2024 to employees and nonemployees were 706,321 and 2,500, respectively and the weighted average exercise prices were $0.97 and $0.79, respectively. The weighted-average fair values of the options granted to employees and nonemployees were $0.83 and $0.39, respectively and were estimated using the following Black-Scholes assumptions: Employee Nonemployee Expected term (in years) 6.25 1.50 Risk‑free interest rate 3.87 % 4.53 % Dividend yield — % — % Expected volatility 109.65 % 105.34 % No options were exercised for the three months ended March 31, 2024 under our stock option plans. As of March 31, 2024, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was 849,647. (b) Inducement Grants On February 12, 2024, the Company awarded, outside the 2021 Plan, our Chief Commercial Officer a stock option grant for the right to purchase 100,000 shares of common stock at an exercise price of $1.10 per share (inducement grant), which was approved by the Compensation committee. The inducement grant will vest in equal installments over four years provided the employee remains employed by the Company on the vesting date. The fair value of the inducement grant was $0.94 and was estimated using the following assumptions: Inducement Expected term (in years) 6.25 Risk‑free interest rate 4.10 % Dividend yield — % Expected volatility 109.64 % As of March 31, 2024, inducement grant awards of 250,000 shares were outstanding with a weighted average exercise price of $1.89, and 62,500 shares were vested and exercisable with a weighted average exercise price of $2.64. (c) Share-Based Compensation Expense The following table shows the share-based compensation expense related to vested stock option grants to employees and nonemployees by financial statement line item on the accompanying condensed statement of comprehensive loss: Three Months Ended March 31 2024 2023 Research and development $ 30,327 25,059 Sales and marketing 6,199 (2,544 ) General and administrative 41,059 34,439 Total share-based compensation expense $ 77,585 56,954 As March 31 , 2024 (d) Employee Stock Purchase Plan (ESPP) For the three months ended March 31 , 2024 March 31 , 2024 (e) April 2023 Financing On April 20, 2023, the Company entered into a securities purchase agreement pursuant to which the Company sold (i) 1,318,000 shares of common stock (see Note 11, Stockholders’ Equity The pre-funded warrants, common warrants and placement agent warrants were exercisable immediately following the closing date of the offering. The pre-funded warrants have an unlimited term and an exercise price of $0.0001 per share. The common warrants have a 5.5 year term and an exercise price of $1.095 per share. The placement agent warrants have a 5 year term and exercise price of $1.525 per share. The offering resulted in aggregate gross proceeds of $3,899,813, before $547,764 of transaction costs. The pre-funded warrants and common warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. The common stock was valued at $1,133,480, based on the Company’s stock price. The pre-funded warrants and common warrants were valued at $1,615,701 and $1,854,099, respectively, using the following Black-Scholes assumptions: Pre-funded warrants Common warrants Expected term (in years) 4 4 Risk‑free interest rate 3.83 % 3.83 % Dividend yield — % — % Expected volatility 100.25 % 100.25 % Exercise price $ 0.0001 $ 1.095 Stock price $ 0.86 $ 0.86 Black-Scholes value $ 0.86 $ 0.58 The net proceeds of $3,352,049 were allocated to the common stock, pre-funded warrants and common warrants using the relative fair value method. The valuations were recorded to stockholders’ equity. In June 2023, all pre-funded warrants were exercised for shares of common stock. In September and October 2023, all common warrants and 122,994 placement agent warrants were exercised for cash proceeds of $3,687,976 , 2024, |
Related-Party Transactions
Related-Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related-Party Transactions [Abstract] | |
Related-Party Transactions | (13) Related‑Party Transactions In November 2023, the Company issued unsecured convertible notes and accompanying Series A and Series B Warrants (see Note 9). The transaction included issuance of a $5 million convertible note and Series A and Series B Warrants to PharmaCyte Biotech, Inc. The interim CEO, President and Director of PharmaCyte Biotech, Inc., Joshua Silverman, serves on the Company’s board of directors. During the year ended December 31, 2023 and quarters ended March 31, 2024 and 2023, a family member of the CEO was employed by the Company. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | (14) Net Loss per Share Attributable to Common Stockholders The following table sets forth the computation of the basic and diluted net loss per share: Three Months Ended March 31, 2024 2023 Net loss attributable to common stockholders, basic & diluted $ (3,599,510 ) (2,946,257 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 21,775,357 11,872,255 Net loss per share attributable to common stockholders, basic and diluted $ (0.17 ) (0.25 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive March 31, 2024 March 31, 2023 Options to purchase common stock 2,998,233 1,036,495 Warrants to purchase common stock, in connection with April 2023 financing 68,809 — Warrants to purchase common stock, in connection with November 2023 financing 11,610,166 — Warrants to purchase common stock 201,578 233,460 Total potential shares 14,878,786 1,269,955 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes [Abstract] | |
Income Taxes [Text Block] | (15) Income Taxes The effective tax rate of 0% for the three months ended March 31, 2024 and 2023 was lower than the statutory rate due to the Company remaining in a full valuation allowance position. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | (16) Subsequent Events In April 2024, the Company sold 121,371 shares under the at-the-market facility, resulting in gross cash proceeds of $219,752. |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization, Nature of Busin_2
Organization, Nature of Business, and Liquidity (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Nature of Business, and Liquidity [Abstract] | |
Organization and Nature of Business | Organization and Nature of Business Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a leading biomedical company focused on addressing significant unmet needs for women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, including a lead revolutionary product candidate and FDA-cleared products. The Company’s mission is to provide women with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics focused on servicing the reproductive health needs for those seeking solutions for infertility issues (FemaSeed® and FemVue®) or permanent birth control (FemBloc®). The Company currently operates a segment with an initial focus on servicing the reproductive health needs for those seeking solutions for infertility issues or permanent birth control. Femasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemaSeed, a solution which enables directed intratubal insemination to improve on traditional intrauterine insemination (IUI) and provides a lower cost and safer option to in vitro fertilization methods, received approval to sell FemaSeed in Canada in April 2023. In September 2023, the Company received 510(k) clearance from the FDA for FemaSeed for intratubal insemination to market in the United States. A pivotal clinical trial was still ongoing at the time of receiving regulatory clearance, however, enrollment was completed in November 2023. FemVue, a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S., Japan, and Canada. FemChec® allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success). FemCerv® is a solution for complete tissue sampling with minimal contamination of the endocervical canal in a virtually pain-free procedure as an alternative to the single biopsy method and is approved for sale in the U.S. and Canada. FemCath®, allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter that is undirected, is approved for sale in the U.S. and Canada. FemBloc ® |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying condensed financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to these rules and regulations. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2023 included in our Annual Report on Form 10K filed with the SEC on March 28, 2024 (the Annual Report). There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in the Annual Report. In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows at the dates for periods presented. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expense during the reporting periods. Estimates for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates. |
Liquidity | Liquidity As of March 31, 2024, the Company had cash and cash equivalents of $17,835,968. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue primarily anticipated from the sale of FemVue and FemaSeed to support the Company’s research and development activities, largely in connection with FemBloc. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted. For the three months ended March 31, 2024, the Company generated a net loss of $3,599,510. The Company expects such losses to increase over the next few years as the Company advances FemBloc through clinical development until FDA approval is received and is available to be marketed. The Company believes that its cash and cash equivalents as of March 31, 2024 and cash received subsequent to quarter end (see Note 16 , Subsequent Events ) will be sufficient to fund our ongoing operations at least 12 months from the date of filing these condensed financial statements. |
Recently Issued Accounting Pronouncements Adopted and Not Yet Adopted | Recently Issued Accounting Pronouncements – Recently Adopted I Segment Reporting (Topic 28): Improvements to Reportable Segment Disclosures Recently Issued Accounting Pronouncements – Not Yet Adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company’s annual reporting periods beginning after December 15, 2024. Adoption is either with a prospective method or a fully retrospective method of transition. Early adoption is permitted. The Company is currently evaluating the effect that adoption of ASU 2023-09 will have on its financial statements and expects to adopt the ASU on January 1, 2025. No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s financial statements. |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventories [Abstract] | |
Inventory Stated at Cost, Net of Reserve | Inventory stated at cost, net of reserve, consisted of the following: March 31, December 31, 2024 2023 Materials $ 574,199 367,934 Work in progress 131,657 128,993 Finished goods 265,441 170,191 Inventory, net $ 971,297 667,118 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following: March 31, December 31, 2024 2023 Clinical trial costs $ 243,367 276,141 Accrued interest 147,275 — Incentive and other compensation costs 146,409 1,082,606 Director fees 70,000 60,210 Franchise taxes 12,800 12,160 Other 53,606 13,179 Accrued expenses $ 673,457 1,444,296 |
Clinical Holdback (Tables)
Clinical Holdback (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Clinical Holdback [Abstract] | |
Clinical Holdback Liability | The following table shows the activity within the clinical holdback liability accounts for the three months ended March 31, 2024: Balance at December 31, 2023 $ 120,235 Clinical holdback retained 3,530 Clinical holdback paid — Balance at March 31, 2024 $ 123,765 Less: clinical holdback - current portion (93,376 ) Clinical holdback - long-term portion $ 30,389 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Revenue Recognition [Abstract] | |
Sales by Geographic Region | The following table summarizes our sales, primarily from FemVue, by geographic region as follows: Three Months Ended March 31, Primary geographical markets 2024 2023 U.S. $ 271,140 293,984 International — — Total $ 271,140 293,984 |
Convertible Notes with Warran_2
Convertible Notes with Warrants (November 2023 Financing) (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Convertible Notes with Warrants (November 2023 Financing) [Abstract] | |
Fair Value Warrant and Black-Scholes Warrant Assumptions | The Series A and Series B Warrants were valued using the relative fair value method and the following Black-Scholes assumptions: Series A Warrants Series B Warrants Expected term (in years) 5 1 Risk‑free interest rate 4.55 % 5.24 % Dividend yield — % — % Expected volatility 104.89 % 113.84 % Exercise price $ 1.18 $ 1.48 Stock price $ 0.95 $ 0.95 Black-Scholes value $ 0.55 $ 0.28 |
Equity Incentive Plans and Wa_2
Equity Incentive Plans and Warrants (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity Incentive Plans and Warrants [Abstract] | |
Stock Option Plan Activity | Activity under the Company’s stock option plans for the three months ended March 31, 2024 was as follows: Number of options Weighted average exercise price Outstanding at December 31, 2023 2,102,030 $ 2.00 Granted 708,821 0.97 Forfeited (62,618 ) 2.59 Outstanding at March 31, 2024 2,748,233 $ 1.72 Vested and exercisable at March 31 1,208,627 $ 2.63 |
Share-based Compensation Expense | The following table shows the share-based compensation expense related to vested stock option grants to employees and nonemployees by financial statement line item on the accompanying condensed statement of comprehensive loss: Three Months Ended March 31 2024 2023 Research and development $ 30,327 25,059 Sales and marketing 6,199 (2,544 ) General and administrative 41,059 34,439 Total share-based compensation expense $ 77,585 56,954 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants Valuation Assumptions | The common stock was valued at $1,133,480, based on the Company’s stock price. The pre-funded warrants and common warrants were valued at $1,615,701 and $1,854,099, respectively, using the following Black-Scholes assumptions: Pre-funded warrants Common warrants Expected term (in years) 4 4 Risk‑free interest rate 3.83 % 3.83 % Dividend yield — % — % Expected volatility 100.25 % 100.25 % Exercise price $ 0.0001 $ 1.095 Stock price $ 0.86 $ 0.86 Black-Scholes value $ 0.86 $ 0.58 |
2021 Stock Option Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Estimated Using Assumptions | Options granted under our 2021 Stock Option Plan for the three months ended March 31, 2024 to employees and nonemployees were 706,321 and 2,500, respectively and the weighted average exercise prices were $0.97 and $0.79, respectively. The weighted-average fair values of the options granted to employees and nonemployees were $0.83 and $0.39, respectively and were estimated using the following Black-Scholes assumptions: Employee Nonemployee Expected term (in years) 6.25 1.50 Risk‑free interest rate 3.87 % 4.53 % Dividend yield — % — % Expected volatility 109.65 % 105.34 % |
Inducement Grant [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Estimated Using Assumptions | On February 12, 2024, the Company awarded, outside the 2021 Plan, our Chief Commercial Officer a stock option grant for the right to purchase 100,000 shares of common stock at an exercise price of $1.10 per share (inducement grant), which was approved by the Compensation committee. The inducement grant will vest in equal installments over four years provided the employee remains employed by the Company on the vesting date. The fair value of the inducement grant was $0.94 and was estimated using the following assumptions: Inducement Expected term (in years) 6.25 Risk‑free interest rate 4.10 % Dividend yield — % Expected volatility 109.64 % |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of the basic and diluted net loss per share: Three Months Ended March 31, 2024 2023 Net loss attributable to common stockholders, basic & diluted $ (3,599,510 ) (2,946,257 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 21,775,357 11,872,255 Net loss per share attributable to common stockholders, basic and diluted $ (0.17 ) (0.25 ) |
Computations of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive March 31, 2024 March 31, 2023 Options to purchase common stock 2,998,233 1,036,495 Warrants to purchase common stock, in connection with April 2023 financing 68,809 — Warrants to purchase common stock, in connection with November 2023 financing 11,610,166 — Warrants to purchase common stock 201,578 233,460 Total potential shares 14,878,786 1,269,955 |
Organization, Nature of Busin_3
Organization, Nature of Business, and Liquidity (Details) | 3 Months Ended | ||
Mar. 31, 2024 USD ($) Women Segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Organization and Nature of Business [Abstract] | |||
Number of operating segments | Segment | 1 | ||
Number of women used FemBloc for permanent birth control | 401 | ||
Number of year where women's used for permanent birth control. | 1 year | ||
Number of women enrolled for a clinical readout | 50 | ||
Number of women need to use for interim analysis of clinical data for permanent birth control | 300 | ||
Period for analysis of clinical data for permanent birth control | 1 year | ||
Follow-up period for interim analysis of clinical data for permanent birth control | 5 years | ||
Liquidity [Abstract] | |||
Cash and cash equivalents | $ | $ 17,835,968 | $ 21,716,077 | |
Net loss | $ | $ (3,599,510) | $ (2,946,257) |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Level 1 [Member] | Money Market Funds [Member] | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalent | $ 17,503,242 | $ 21,278,895 |
Inventories (Details)
Inventories (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Inventories [Abstract] | ||
Materials | $ 574,199 | $ 367,934 |
Work in progress | 131,657 | 128,993 |
Finished goods | 265,441 | 170,191 |
Inventory, net | $ 971,297 | $ 667,118 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued Expenses [Abstract] | ||
Clinical trail costs | $ 243,367 | $ 276,141 |
Accrued interest | 147,275 | 0 |
Incentive and other compensation costs | 146,409 | 1,082,606 |
Director fees | 70,000 | 60,210 |
Franchise taxes | 12,800 | 12,160 |
Other | 53,606 | 13,179 |
Accrued expenses | $ 673,457 | $ 1,444,296 |
Clinical Holdback (Details)
Clinical Holdback (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Clinical Holdback Liability [Roll Forward] | ||
Balance | $ 120,235 | |
Clinical holdback retained | 3,530 | |
Clinical holdback paid | 0 | |
Balance | 123,765 | |
Less: clinical holdback - current portion | (93,376) | $ (65,300) |
Clinical holdback - long-term portion | $ 30,389 | $ 54,935 |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue Recognition [Abstract] | ||
Revenue recognized from performance obligations in prior periods | $ 0 | $ 0 |
Percentage of restocking fee | 30% | |
Primary Geographical Markets [Abstract] | ||
Sales | $ 271,140 | 293,984 |
FemVue [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 271,140 | 293,984 |
FemVue [Member] | U.S. [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 271,140 | 293,984 |
FemVue [Member] | International [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | $ 0 | $ 0 |
Minimum [Member] | ||
Revenue Recognition [Abstract] | ||
Revenue recognition payment period term | 30 days | |
Maximum [Member] | ||
Revenue Recognition [Abstract] | ||
Revenue recognition payment period term | 60 days |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Jul. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Notes Payable [Abstract] | |||||
Down payments | $ 0 | $ 141,298 | |||
July Promissory Note [Member] | AFCO Credit Corporation [Member] | |||||
Notes Payable [Abstract] | |||||
Proceeds to pay insurance premiums | $ 469,042 | ||||
Down payments | $ 48,423 | ||||
Interest rate | 8.60% | ||||
Frequency of installment payments | monthly | ||||
Monthly principal and interest payments | $ 48,423 | ||||
Maturity date of loan | Nov. 30, 2023 | ||||
Note payable | $ 0 | $ 0 | |||
Interest expense on loan | $ 0 | $ 1,319 | |||
June Promissory Note [Member] | AFCO Credit Corporation [Member] | |||||
Notes Payable [Abstract] | |||||
Proceeds to pay insurance premiums | $ 465,380 | ||||
Down payments | $ 47,539 | ||||
Interest rate | 5.70% | ||||
Frequency of installment payments | monthly | ||||
Monthly principal and interest payments | $ 47,539 | ||||
Maturity date of loan | Mar. 31, 2023 |
Convertible Notes with Warran_3
Convertible Notes with Warrants (November 2023 Financing), Summary (Details) - November 2023 Financing [Member] - USD ($) | 3 Months Ended | ||
Nov. 21, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Convertible Notes [Abstract] | |||
Proceeds from convertible notes | $ 6,850,000 | ||
Transaction costs | $ 525,144 | ||
Conversion price, period | 18 months | ||
Conversion price of common stock exceeds (in dollars per share) | $ 2.36 | ||
Consecutive trading days | 10 days | ||
Daily dollar trading volume of common stock exceeds per day | $ 1,000,000 | ||
Notes redeem at premium, percentage | 115% | ||
Series A Warrants [Member] | |||
Convertible Notes [Abstract] | |||
Warrants purchase shares of common stock (in shares) | 5,805,083 | ||
Warrants exercise price (in dollars per share) | $ 1.18 | ||
Consecutive trading days | 10 days | ||
Daily dollar trading volume of common stock exceeds per day | $ 1,000,000 | ||
Series B Warrants [Member] | |||
Convertible Notes [Abstract] | |||
Consecutive trading days | 10 days | ||
Daily dollar trading volume of common stock exceeds per day | $ 1,000,000 | ||
Convertible Notes [Member] | |||
Convertible Notes [Abstract] | |||
Aggregate principal amount | $ 6,850,000 | $ 6,850,000 | |
Convertible note accrue interest rate | 6% | ||
Maturity date | Nov. 21, 2025 | ||
Convertible Notes [Member] | Series B Warrants [Member] | |||
Convertible Notes [Abstract] | |||
Warrants purchase shares of common stock (in shares) | 5,805,083 | ||
Warrants exercise price (in dollars per share) | $ 1.475 | ||
Convertible Notes [Member] | Common Stock [Member] | |||
Convertible Notes [Abstract] | |||
Aggregate principal amount | $ 6,850,000 | ||
Conversion price (in dollars per share) | $ 1.18 |
Convertible Notes with Warran_4
Convertible Notes with Warrants (November 2023 Financing), Warrants (Details) - November 2023 Financing [Member] | 3 Months Ended | |
Nov. 21, 2023 USD ($) | Mar. 31, 2024 $ / shares | |
Warrants [Abstract] | ||
Consecutive trading days | 10 days | |
Daily dollar trading volume of common stock exceeds per day | $ 1,000,000 | |
Proceeds from convertible notes | 6,850,000 | |
Transaction costs | 525,144 | |
Fair value of warrants | 2,219,165 | |
Debt discount | $ 2,744,309 | |
Series A Warrants [Member] | ||
Warrants [Abstract] | ||
Percentage of warrant closing price of common stock exceeds | 200% | |
Consecutive trading days | 10 days | |
Daily dollar trading volume of common stock exceeds per day | $ 1,000,000 | |
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants term | 5 years | |
Black-Scholes value (in dollars per share) | $ / shares | $ 0.55 | |
Series A Warrants [Member] | Risk-free Interest Rate [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 0.0455 | |
Series A Warrants [Member] | Dividend Yield [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 0 | |
Series A Warrants [Member] | Expected Volatility [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 1.0489 | |
Series A Warrants [Member] | Exercise Price [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 1.18 | |
Series A Warrants [Member] | Stock Price [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 0.95 | |
Series B Warrants [Member] | ||
Warrants [Abstract] | ||
Percentage of warrant closing price of common stock exceeds | 200% | |
Consecutive trading days | 10 days | |
Daily dollar trading volume of common stock exceeds per day | $ 1,000,000 | |
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants term | 1 year | |
Black-Scholes value (in dollars per share) | $ / shares | $ 0.28 | |
Series B Warrants [Member] | Risk-free Interest Rate [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 0.0524 | |
Series B Warrants [Member] | Dividend Yield [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 0 | |
Series B Warrants [Member] | Expected Volatility [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 1.1384 | |
Series B Warrants [Member] | Exercise Price [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 1.48 | |
Series B Warrants [Member] | Stock Price [Member] | ||
Fair Value Method and Black-Scholes Assumptions [Abstract] | ||
Warrants, measurement input | 0.95 |
Convertible Notes with Warran_5
Convertible Notes with Warrants (November 2023 Financing), Convertible Notes Payable (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Convertible Notes [Abstract] | |||
Amortization of debt discount and issuance costs | $ 258,802 | $ 0 | |
Convertible Notes Payable [Abstract] | |||
Accrued and unpaid interest | 147,275 | $ 0 | |
November 2023 Financing [Member] | Convertible Notes [Member] | |||
Convertible Notes [Abstract] | |||
Interest expense | 361,552 | ||
Coupon interest expense | 102,750 | ||
Amortization of debt discount and issuance costs | 258,802 | ||
Convertible Notes Payable [Abstract] | |||
Notes principal balance | 6,850,000 | 6,850,000 | |
Accrued and unpaid interest | 147,275 | 44,525 | |
Unamortized discount and debt issuance costs | 2,377,544 | $ 2,636,346 | |
Convertible note, fair value | $ 6,185,934 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Apr. 20, 2023 | Apr. 30, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | Oct. 31, 2023 | Jul. 01, 2022 | |
Stockholders Equity [Abstract] | ||||||||
Common stock sold (in shares) | 1,318,000 | 3,900,000 | ||||||
Proceeds from Issuance of Common Stock | $ 802,242 | $ 3,373 | $ 8,700,000 | |||||
Gross proceeds from offering | $ 3,899,813 | $ 3,899,813 | ||||||
Placement agent fees expenses and offering expenses | $ 547,764 | |||||||
Common stock, outstanding (in shares) | 22,099,347 | 22,099,347 | 21,657,381 | |||||
Dividends declared or paid | $ 0 | |||||||
Maximum [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Authorized offering amount of securities | $ 150,000,000 | |||||||
Common stock authorized value to be issued by Sales Agent | $ 16,700,000 | |||||||
Pre-funded Warrants [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Warrants issued to purchase common stock (in shares) | 1,878,722 | |||||||
Purchase price (in dollars per share) | $ 1.2199 | |||||||
Pre-funded Warrants [Member] | Maximum [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Warrants issued to purchase common stock (in shares) | 1,878,722 | |||||||
Common Warrants [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Warrants issued to purchase common stock (in shares) | 3,196,722 | |||||||
Common Warrants [Member] | Maximum [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Warrants issued to purchase common stock (in shares) | 3,196,722 | |||||||
Placement Agent Warrants [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Warrants issued to purchase common stock (in shares) | 191,803 | |||||||
Placement Agent Warrants [Member] | Maximum [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Warrants issued to purchase common stock (in shares) | 191,803 | |||||||
Common Stock [Member] | ||||||||
Stockholders Equity [Abstract] | ||||||||
Common stock sold (in shares) | 1,318,000 | |||||||
Purchase price (in dollars per share) | $ 1.22 |
Equity Incentive Plans and Wa_3
Equity Incentive Plans and Warrants, Stock Option Plan, Activity (Details) - 2021 Stock Option Plan [Member] | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Number of Options [Roll Forward] | |
Beginning balance (in shares) | shares | 2,102,030 |
Granted (in shares) | shares | 708,821 |
Forfeited (in shares) | shares | (62,618) |
Ending balance (in shares) | shares | 2,748,233 |
Weighted Average Exercise Price [Abstract] | |
Beginning balance (in dollars per share) | $ / shares | $ 2 |
Granted (in dollars per share) | $ / shares | 0.97 |
Forfeited (in dollars per share) | $ / shares | 2.59 |
Ending balance (in dollars per share) | $ / shares | $ 1.72 |
Options vested and exercisable [Abstract] | |
Options vested and exercisable, Number of option vested (in shares) | shares | 1,208,627 |
Options vested and exercisable, Exercise price (in dollars per share) | $ / shares | $ 2.63 |
Estimated Fair Value Assumptions [Abstract] | |
Options exercised (in shares) | shares | 0 |
Common stock reserved for issuance (in shares) | shares | 849,647 |
Employees [Member] | |
Number of Options [Roll Forward] | |
Granted (in shares) | shares | 706,321 |
Weighted Average Exercise Price [Abstract] | |
Granted (in dollars per share) | $ / shares | $ 0.97 |
Options vested and exercisable [Abstract] | |
Weighted-average fair values of options granted (in dollars per share) | $ / shares | $ 0.83 |
Estimated Fair Value Assumptions [Abstract] | |
Expected term (in years) | 6 years 3 months |
Risk free interest rate | 3.87% |
Dividend yield | 0% |
Expected volatility | 109.65% |
Nonemployee [Member] | |
Number of Options [Roll Forward] | |
Granted (in shares) | shares | 2,500 |
Weighted Average Exercise Price [Abstract] | |
Granted (in dollars per share) | $ / shares | $ 0.79 |
Options vested and exercisable [Abstract] | |
Weighted-average fair values of options granted (in dollars per share) | $ / shares | $ 0.39 |
Estimated Fair Value Assumptions [Abstract] | |
Expected term (in years) | 1 year 6 months |
Risk free interest rate | 4.53% |
Dividend yield | 0% |
Expected volatility | 105.34% |
Equity Incentive Plans and Wa_4
Equity Incentive Plans and Warrants, Inducement Grant (Details) - Inducement Grant [Member] - $ / shares | Feb. 12, 2024 | Mar. 31, 2024 |
Inducement Grant [Abstract] | ||
Granted (in shares) | 100,000 | |
Weighted average exercise price (in dollars per share) | $ 1.1 | $ 1.89 |
Vesting period | 4 years | |
Weighted-average fair values of options granted (in dollars per share) | $ 0.94 | |
Estimated Fair Value Assumptions [Abstract] | ||
Expected term (in years) | 6 years 3 months | |
Risk free interest rate | 4.10% | |
Dividend yield | 0% | |
Expected volatility | 109.64% | |
Shares outstanding (in shares) | 250,000 | |
Options vested and exercisable, Number of option vested (in shares) | 62,500 | |
Options vested and exercisable, Weighted average exercise price (in dollars per shares) | $ 2.64 |
Equity Incentive Plans and Wa_5
Equity Incentive Plans and Warrants, Share-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 77,585 | $ 56,954 |
Share-based compensation expense expected to be recognized for employees and nonemployees | 1,411,405 | |
Compensation expense to be recognized upon achieving certain performance condition | 155,222 | |
Unrecognized expenses | $ 1,256,183 | |
Weighted-average period over which unrecognized compensation is expected to be recognized | 3 years 3 months 18 days | |
Research and Development [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 30,327 | 25,059 |
Sales and Marketing [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | 6,199 | (2,544) |
General and Administrative [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 41,059 | $ 34,439 |
Equity Incentive Plans and Wa_6
Equity Incentive Plans and Warrants, Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan [Member] | 3 Months Ended |
Mar. 31, 2024 shares | |
Employee Stock Purchase Plan [Abstract] | |
Stock issued (in shares) | 0 |
Common stock reserved for issuance (in shares) | 603,518 |
Equity Incentive Plans and Wa_7
Equity Incentive Plans and Warrants, April 2023 Financing (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Apr. 20, 2023 | Oct. 31, 2023 | Sep. 30, 2023 | Apr. 30, 2023 | Mar. 31, 2024 | |
Warrants [Abstract] | |||||
Issuance and sale of common stock (in shares) | 1,318,000 | 3,900,000 | |||
Gross proceeds from offering | $ 3,899,813 | $ 3,899,813 | |||
Transaction costs | 547,764 | ||||
Common stock value | 1,133,480 | ||||
Estimated Fair Value Assumptions [Abstract] | |||||
Net proceeds from issuance of common stock and warrants | $ 3,352,049 | ||||
Pre-funded Warrants [Member] | |||||
Warrants [Abstract] | |||||
Warrants issued to purchase common stock (in shares) | 1,878,722 | ||||
Warrants exercise price (In dollars per share) | $ 0.0001 | ||||
Common stock value | $ 1,615,701 | ||||
Estimated Fair Value Assumptions [Abstract] | |||||
Expected term (in years) | 4 years | ||||
Risk free interest rate | 3.83% | ||||
Dividend yield | 0% | ||||
Expected volatility | 100.25% | ||||
Exercise price (in dollars per share) | $ 0.0001 | ||||
Stock price (in dollars per share) | 0.86 | ||||
Black-Scholes value (in dollars per share) | $ 0.86 | ||||
Common Warrants [Member] | |||||
Warrants [Abstract] | |||||
Warrants issued to purchase common stock (in shares) | 3,196,722 | ||||
Warrants term | 5 years 6 months | ||||
Warrants exercise price (In dollars per share) | $ 1.095 | ||||
Common stock value | $ 1,854,099 | ||||
Estimated Fair Value Assumptions [Abstract] | |||||
Expected term (in years) | 4 years | ||||
Risk free interest rate | 3.83% | ||||
Dividend yield | 0% | ||||
Expected volatility | 100.25% | ||||
Exercise price (in dollars per share) | $ 1.095 | ||||
Stock price (in dollars per share) | 0.86 | ||||
Black-Scholes value (in dollars per share) | $ 0.58 | ||||
Placement Agent Warrants [Member] | |||||
Warrants [Abstract] | |||||
Warrants issued to purchase common stock (in shares) | 191,803 | ||||
Warrants term | 5 years | ||||
Warrants exercise price (In dollars per share) | $ 1.525 | ||||
Estimated Fair Value Assumptions [Abstract] | |||||
Warrants exercised (in shares) | 122,994 | 122,994 | |||
Cash proceeds from warrants exercised | $ 3,687,976 | $ 3,687,976 | |||
Warrants outstanding (in shares) | 68,809 |
Related-Party Transactions (Det
Related-Party Transactions (Details) $ in Millions | 1 Months Ended |
Nov. 30, 2023 USD ($) | |
Related-Party Transactions [Abstract] | |
Related-party transaction | $ 5 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net Income (Loss) Available to Common Stockholders, Basic [Abstract] | ||
Net loss attributable to common stockholders, basic | $ (3,599,510) | $ (2,946,257) |
Net loss attributable to common stockholders, diluted | $ (3,599,510) | $ (2,946,257) |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 21,775,357 | 11,872,255 |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 21,775,357 | 11,872,255 |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.17) | $ (0.25) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.17) | $ (0.25) |
Weighted Average Number of Shares Outstanding [Abstract] | ||
Options to purchase common stock (in shares) | 2,998,233 | 1,036,495 |
Warrants to purchase common stock (in shares) | 201,578 | 233,460 |
Total potential shares (in shares) | 14,878,786 | 1,269,955 |
April 2023 Financing [Member] | ||
Weighted Average Number of Shares Outstanding [Abstract] | ||
Warrants to purchase common stock in connection financing (in shares) | 68,809 | 0 |
November 2023 Financing [Member] | ||
Weighted Average Number of Shares Outstanding [Abstract] | ||
Warrants to purchase common stock in connection financing (in shares) | 11,610,166 | 0 |
Income Taxes (Details)
Income Taxes (Details) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||
Effective tax rate | 0% | 0% |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | |
Apr. 20, 2023 | Apr. 30, 2024 | |
Issuance Sale of Common Stock [Abstract] | ||
Gross cash proceeds from offering | $ 3,352,049 | |
Subsequent Event [Member] | At-the-Market Facility [Member] | ||
Issuance Sale of Common Stock [Abstract] | ||
Sale of common stock (in shares) | 121,371 | |
Gross cash proceeds from offering | $ 219,752 |