Femasys (FEMY) 10-Q12 Nov 242024 Q3 Quarterly reportFinancial data

Company Profile

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 11, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
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		22,898,468

Condensed Balance Sheets

Condensed Balance Sheets - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 7,611,210	$ 21,716,077
Accounts receivable, net	378,290	98,906
Inventory, net	1,937,670	667,118
Prepaid and other current assets	1,370,523	695,879
Total current assets	11,297,693	23,177,980
Property and equipment, at cost:
Leasehold improvements	1,238,886	1,212,417
Office equipment	67,231	47,308
Furniture and fixtures	433,584	414,303
Machinery and equipment	2,848,833	2,559,356
Construction in progress	548,149	423,077
Property and equipment, gross	5,136,683	4,656,461
Less accumulated depreciation	(3,748,393)	(3,545,422)
Net property and equipment	1,388,290	1,111,039
Long-term assets:
Lease right-of-use assets, net	1,941,624	2,380,225
Intangible assets, net of accumulated amortization	70,064	0
Other long-term assets	887,410	1,086,581
Total long-term assets	2,899,098	3,466,806
Total assets	15,585,081	27,755,825
Current liabilities:
Accounts payable	1,121,873	1,137,823
Accrued expenses	1,127,645	1,444,296
Clinical holdback - current portion	92,170	65,300
Lease liabilities - current portion	525,752	406,636
Total current liabilities	2,867,440	3,054,055
Long-term liabilities:
Clinical holdback - long-term portion	36,081	54,935
Convertible notes payable, net (including related parties)	5,068,556	4,258,179
Lease liabilities - long-term portion	1,643,217	2,036,067
Total long-term liabilities	6,747,854	6,349,181
Total liabilities	9,615,294	9,403,236
Commitments and contingencies
Stockholders' equity:
Common stock, $.001 par, 200,000,000 authorized, 22,350,022 shares issued and 22,232,799 outstanding as of September 30, 2024; and 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023	22,350	21,775
Treasury stock, 117,223 common shares	(60,000)	(60,000)
Warrants	2,608,642	2,787,137
Additional paid-in-capital	125,473,368	123,985,306
Accumulated deficit	(122,074,573)	(108,381,629)
Total stockholders' equity	5,969,787	18,352,589
Total liabilities and stockholders' equity	$ 15,585,081	$ 27,755,825

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 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)	22,350,022	21,774,604
Common stock, outstanding (in shares)	22,232,799	21,657,381
Treasury stock, common shares (in shares)	117,223	117,223

Condensed Statements of Compreh

Condensed Statements of Comprehensive Loss - USD ($)	3 Months Ended		9 Months Ended
Condensed Statements of Comprehensive Loss - USD ($)	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Statements of Comprehensive Loss [Abstract]
Sales	$ 554,908	$ 244,361	$ 1,047,532	$ 858,859
Cost of sales (excluding depreciation expense)	190,839	86,186	352,496	301,775
Operating expenses:
Research and development	2,303,241	2,072,830	6,049,847	5,137,441
Sales and marketing	1,572,189	70,883	2,847,866	444,678
General and administrative	1,530,791	1,970,408	4,645,412	4,642,182
Depreciation and amortization	76,288	125,318	215,144	391,683
Total operating expenses	5,482,509	4,239,439	13,758,269	10,615,984
Loss from operations	(5,118,440)	(4,081,264)	(13,063,233)	(10,058,900)
Other income (expense):
Interest income	124,028	92,392	532,850	232,133
Interest expense	(413,290)	(8,033)	(1,163,153)	(9,903)
Total other income (expense), net	(289,262)	84,359	(630,303)	222,230
Loss before income taxes	(5,407,702)	(3,996,905)	(13,693,536)	(9,836,670)
Income tax expense (benefit)	1,158	0	(592)	0
Net loss	(5,408,860)	(3,996,905)	(13,692,944)	(9,836,670)
Net loss attributable to common stockholders, basic	(5,408,860)	(3,996,905)	(13,692,944)	(9,836,670)
Net loss attributable to common stockholders, diluted	$ (5,408,860)	$ (3,996,905)	$ (13,692,944)	$ (9,836,670)
Net loss per share attributable to common stockholders, basic (in dollars per share)	$ (0.24)	$ (0.26)	$ (0.62)	$ (0.74)
Net loss per share attributable to common stockholders, diluted (in dollars per share)	$ (0.24)	$ (0.26)	$ (0.62)	$ (0.74)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic (in shares)	22,232,799	15,093,147	22,075,135	13,369,462
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted (in shares)	22,232,799	15,093,147	22,075,135	13,369,462

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		$ 567,972	$ 108,857,065	$ (94,134,505)	$ 15,242,519
Balance (in shares) at Dec. 31, 2022	11,986,927
Treasury stock, common value at Dec. 31, 2022		$ (60,000)
Treasury stock, common shares (in shares) at Dec. 31, 2022		117,223
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock and warrants in connection with April 2023 Financing, net of issuance costs	$ 1,318	$ 0	2,526,664	818,014	0	3,345,996
Issuance of common stock and warrants in connection with April 2023 Financing, net of issuance costs (in shares)	1,318,000
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
Issuance of common stock in connection with ESPP	$ 3	$ 0	0	1,694	0	1,697
Issuance of common stock in connection with ESPP (in shares)	3,858	0
Exercise of pre-funded warrants	$ 1,879	$ 0	(1,176,533)	1,174,842	0	188
Exercise of pre-funded warrants (in shares)	1,878,722	0
Exercise of common warrants	$ 920	$ 0	(336,495)	1,395,550	0	1,059,975
Exercise of common warrants (in shares)	919,716	0
Share-based compensation expense	$ 0	$ 0	0	626,529	0	626,529
Net loss	0	0	0	0	(9,836,670)	(9,836,670)
Treasury stock, common value at Sep. 30, 2023		$ (60,000)
Treasury stock, common shares (in shares) at Sep. 30, 2023		117,223
Balance at Sep. 30, 2023	$ 16,110		1,581,608	112,877,059	(103,971,175)	10,443,602
Balance (in shares) at Sep. 30, 2023	16,110,092
Balance at Jun. 30, 2023	$ 15,190		1,918,103	110,977,150	(99,974,270)	12,876,173
Balance (in shares) at Jun. 30, 2023	15,190,376
Treasury stock, common value at Jun. 30, 2023		$ (60,000)
Treasury stock, common shares (in shares) at Jun. 30, 2023		117,223
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common warrants	$ 920		(336,495)	1,395,550		1,059,975
Exercise of common warrants (in shares)	919,716
Share-based compensation expense	$ 0	$ 0	0	504,359	0	504,359
Net loss	0	0	0	0	(3,996,905)	(3,996,905)
Treasury stock, common value at Sep. 30, 2023		$ (60,000)
Treasury stock, common shares (in shares) at Sep. 30, 2023		117,223
Balance at Sep. 30, 2023	$ 16,110		1,581,608	112,877,059	(103,971,175)	10,443,602
Balance (in shares) at Sep. 30, 2023	16,110,092
Balance at Dec. 31, 2023	$ 21,775		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 value at Dec. 31, 2023		$ (60,000)				$ (60,000)
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	$ 563	$ 0	0	989,185	0	$ 989,748
Issuance of common stock in connection with at-the-market offering, net of issuance costs (in shares)	563,337	0
Issuance of common stock in connection with ESPP	$ 12	$ 0	0	10,378	0	10,390
Issuance of common stock in connection with ESPP (in shares)	12,081	0
Expiration of Warrant	$ 0	$ 0	(178,495)	178,495	0	0
Share-based compensation expense	0	0	0	310,004	0	310,004
Net loss	0	0	0	0	(13,692,944)	(13,692,944)
Treasury stock, common value at Sep. 30, 2024		$ (60,000)				$ (60,000)
Treasury stock, common shares (in shares) at Sep. 30, 2024		117,223				117,223
Balance at Sep. 30, 2024	$ 22,350		2,608,642	125,473,368	(122,074,573)	$ 5,969,787
Balance (in shares) at Sep. 30, 2024	22,350,022					22,350,022
Balance at Jun. 30, 2024	$ 22,350		2,608,642	125,344,962	(116,665,713)	$ 11,250,241
Balance (in shares) at Jun. 30, 2024	22,350,022
Treasury stock, common value at Jun. 30, 2024		$ (60,000)
Treasury stock, common shares (in shares) at Jun. 30, 2024		117,223
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with at-the-market offering, net of issuance costs	$ 0	$ 0	0	0	0	0
Issuance of common stock in connection with at-the-market offering, net of issuance costs (in shares)	0	0
Issuance of common stock in connection with ESPP	$ 0	$ 0	0	0	0	0
Issuance of common stock in connection with ESPP (in shares)	0	0
Expiration of Warrant	$ 0	$ 0	0	0	0	0
Share-based compensation expense	0	0	0	128,406	0	128,406
Net loss	0	0	0	0	(5,408,860)	(5,408,860)
Treasury stock, common value at Sep. 30, 2024		$ (60,000)				$ (60,000)
Treasury stock, common shares (in shares) at Sep. 30, 2024		117,223				117,223
Balance at Sep. 30, 2024	$ 22,350		$ 2,608,642	$ 125,473,368	$ (122,074,573)	$ 5,969,787
Balance (in shares) at Sep. 30, 2024	22,350,022					22,350,022

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows - USD ($)	9 Months Ended
Condensed Statements of Cash Flows - USD ($)	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (13,692,944)	$ (9,836,670)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	202,971	388,777
Amortization	12,173	2,906
Amortization of right-of-use assets	438,601	274,158
Loss on disposal of assets	0	44,538
Accounts receivable reserve	6,000	0
Inventory reserve	2,830	4,972
Share-based compensation expense	310,004	626,529
Amortization of debt issuance costs and discount	854,902	0
Changes in operating assets and liabilities:
Accounts receivable	(285,384)	(26,086)
Inventory	(1,273,382)	(170,917)
Prepaid and other assets	(266,518)	313,154
Accounts payable	(51,799)	341,119
Accrued expenses	(316,651)	112,728
Lease liabilities	(273,734)	(304,004)
Other liabilities	(36,509)	(15,770)
Net cash used in operating activities	(14,369,440)	(8,244,566)
Cash flows from investing activities:
Acquisition of patents	(82,237)	0
Purchases of property and equipment	(654,914)	(99,018)
Net cash used in investing activities	(737,151)	(99,018)
Cash flows from financing activities:
Proceeds from the issuance of common stock and warrants in April 2023 Financing	0	3,899,813
Equity issuance costs for April 2023 Financing	0	(547,764)
Proceeds from exercise of pre-funded warrants	0	188
Proceeds from exercise of common warrants	0	1,059,975
Proceeds from common stock issued through ESPP and exercised options	10,390	1,697
Proceeds from at-the-market sales of common stock	1,021,994	3,373
Issuance costs for at-the-market sales of common stock	(30,660)	0
Repayment of note payable	0	(327,006)
Payments under lease obligations	0	(16,193)
Net cash provided by financing activities	1,001,724	4,074,083
Net change in cash and cash equivalents	(14,104,867)	(4,269,501)
Cash and cash equivalents:
Beginning of period	21,716,077	12,961,936
End of period	7,611,210	8,692,435
Cash paid for:
Interest	0	9,903
Taxes	5,708	4,550
Non-cash investing and financing activities:
Property and equipment costs included in accounts payable and accrued expense	35,849	0
Commissions costs relating to certain proceeds from issuance of common stock	0	6,163
Deferred offering costs reclassified to additional paid-in-capital	1,586	0
Right-of-use asset obtained in exchange for a lease liability	0	2,496,968
Prepaid insurance financed with promissory notes	$ 0	$ 283,334

Organization, Nature of Busines

Organization, Nature of Business, and Liquidity	9 Months Ended
Organization, Nature of Business, and Liquidity	Sep. 30, 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 for four products: FemaSeed, FemVue, FemCerv® and FemCath®. 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. 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 for diagnosis of cervical cancer 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. I ®, a controlled contrast generating device. FemBloc®, the Company’s solution for permanent birth control, is based on the Company’s platform technology for delivery and in June 2023 Femasys received FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, non-hormonal in-office solution for permanent birth control in a pivotal clinical trial. In August 2023 Femasys announced the initiation of enrollment in the FINALE [Prospective Multi-Center Trial for FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control] pivotal trial designed to evaluate the safety and efficacy of FemBloc. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have relied on FemBloc for one year for permanent birth control. In addition, the study is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for permanent birth control for one year. Follow-up will continue annually for five years post-market. 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 September 30, 2024, the Company had cash and cash equivalents of $7,611,210. 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 FemaSeed and For the nine months ended September $13,692,944. The Company expects such losses to increase over the next few years as the Company advances FemBloc through clinical development if and until FDA approval is received and is available to be marketed. The financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of September Recently Issued Accounting Pronouncements I n November 2023, the FASB issued ASU No. 2023-07, 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	9 Months Ended
Fair Value	Sep. 30, 2024
Fair Value [Abstract]
Fair Value	(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 other liabilities approximate their fair value because of the short‑term maturity of these financial instruments. The fair value of stock options, convertible notes and warrants are based on Level 3 inputs.

Cash and Cash Equivalents

Cash and Cash Equivalents	9 Months Ended
Cash and Cash Equivalents	Sep. 30, 2024
Cash and Cash Equivalents [Abstract]
Cash and Cash Equivalents	(3) Cash and Cash Equivalents As of September 30, 2024 and December 31, 2023, money market funds included in cash and cash equivalents on the balance sheets were $6,809,936 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	9 Months Ended
Inventories	Sep. 30, 2024
Inventories [Abstract]
Inventories	(4) Inventories Inventory stated at cost, net of reserve, consisted of the following: September 30 December 31, 2024 2023 Materials $ 1,043,045 367,934 Work in progress 509,217 128,993 Finished goods 385,408 170,191 Inventory, net $ 1,937,670 667,118

Accrued Expenses

Accrued Expenses	9 Months Ended
Accrued Expenses	Sep. 30, 2024
Accrued Expenses [Abstract]
Accrued Expenses	(5) Accrued Expenses Accrued expenses consisted of the following: September 30, December 31, 2024 2023 Accrued interest $ 352,775 — Clinical trial costs 350,208 276,141 Incentive and other compensation costs 297,897 1,082,606 Director fees 70,000 60,210 Franchise taxes 3,150 12,160 Other 53,615 13,179 Accrued expenses $ 1,127,645 1,444,296

Clinical Holdback

Clinical Holdback	9 Months Ended
Clinical Holdback	Sep. 30, 2024
Clinical Holdback [Abstract]
Clinical Holdback	(6) Clinical Holdback The following table shows the activity within the clinical holdback liability accounts for the nine months ended September 30, 2024: Balance at December 31, 2023 $ 120,235 Clinical holdback retained 14,465 Clinical holdback paid (6,449 ) Balance at September 30, 2024 $ 128,251 Less: clinical holdback - current portion (92,170 ) Clinical holdback - long-term portion $ 36,081

Revenue Recognition

Revenue Recognition	9 Months Ended
Revenue Recognition	Sep. 30, 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 and nine months ended September 30, 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 September 30, 2024 or December 31, 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 by geographic region as follows: Three Months Ended September 30, Nine Months Ended September 30, Primary geographical markets 2024 2023 2024 2023 U.S. $ 262,458 244,361 755,082 800,814 International 292,450 — 292,450 58,045 Total $ 554,908 244,361 1,047,532 858,859

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 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 September

Notes Payable

Notes Payable	9 Months Ended
Notes Payable	Sep. 30, 2024
Notes Payable [Abstract]
Notes Payable	(9) Notes Payable AFCO Credit Corporation (AFCO) 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 was $48,423, which represents principal and interest. The Promissory Note was paid in full without penalty in November 2023 As of September and December there was no principal balance on the AFCO. Interest expense in connection with the AFCO promissory notes was and for the and nine months ended September and respectively.

Convertible Notes with Warrants

Convertible Notes with Warrants (November 2023 Financing)	9 Months Ended
Convertible Notes with Warrants (November 2023 Financing)	Sep. 30, 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 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 September 30, 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. For the convertible notes for the three months e nded September 30, 2024, the Company recognized total interest expense of $413,290, including coupon interest expense of $102,750 and amortization of debt discount and issuance costs of $310,540. For the nine months ended September 30, 2024, the Company recognized total interest expense of $1,163,153, including coupon interest expense of $308,250 and amortization of debt discount and issuance costs of $854,902.

Stockholders' Equity

Stockholders' Equity	9 Months Ended
Stockholders' Equity	Sep. 30, 2024
Stockholders' Equity [Abstract]
Stockholders' Equity	(11) Stockholders’ Equity On July 1, 2022, the Company filed a shelf registration statement approximately 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. 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. As of September 30, 2024, 68,809 placement agent warrants remain outstanding. As of September 30, 2024, the Company had 22,232,799 shares of common stock outstanding, and no dividends have been declared or paid.

Equity Incentive Plans and Warr

Equity Incentive Plans and Warrants	9 Months Ended
Equity Incentive Plans and Warrants	Sep. 30, 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 nine months ended September 30, 2024 was as follows: Number of options Weighted average exercise price Outstanding at December 31, 2023 2,102,030 $ 2.00 Granted 1,259,421 1.07 Forfeited (359,807 ) 1.96 Outstanding at September 30, 2024 3,001,644 $ 1.61 Vested and exercisable at September 30 1,295,956 $ 2.36 Options granted under our 2021 Stock Option Plan for the nine months ended September 30, 2024 to employees and nonemployees were 1,186,521 and 72,900, respectively and the weighted average exercise prices were $1.06 and $1.13, respectively. The weighted-average fair values of the options granted to employees and nonemployees were $0.91 and $0.93, respectively and were estimated using the following Black-Scholes assumptions: Employee Nonemployee Expected term (in years) 6.25 5.36 Risk‑free interest rate 4.05 % 4.09 % Dividend yield — % — % Expected volatility 110.29 % 111.97 % No options were exercised for the nine months ended September 30, 2024 under our stock option plans. As of September 30, 2024, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was 596,236. (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 September 30, 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 September 30 Nine September 30 2024 2023 2024 2023 Research and development $ 49,800 79,561 114,437 131,812 Sales and marketing 18,895 623 43,659 (1,319 ) General and administrative 59,711 424,175 151,908 496,036 Total share-based compensation expense $ 128,406 504,359 310,004 626,529 As September 30, 2024 (d) Employee Stock Purchase Plan (ESPP) For the nine months ended September 30, 2024 September 30, 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, (ii) pre-funded warrants to purchase 1,878,722 shares of common stock, (iii) common warrants to purchase 3,196,722 shares of common stock. Additionally, common warrants to purchase 191,803 shares of common stock were issued to the placement agent compensation for services performed. 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 had an unlimited term and an exercise price of $0.0001 per share. The common warrants had 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

Related-Party Transactions

Related-Party Transactions	9 Months Ended
Related-Party Transactions	Sep. 30, 2024
Related-Party Transactions [Abstract]
Related-Party Transactions	(13) Related ‑ In November 2023, the Company issued unsecured convertible notes and accompanying Series A and Series B Warrants (see Note 10). The transaction included the 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. In addition, during the year ended December 31, 2023 and nine months ended September 30, 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	9 Months Ended
Net Loss per Share Attributable to Common Stockholders	Sep. 30, 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 ta ble sets forth the computation of t Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Net loss attributable to common stockholders, basic & diluted $ (5,408,860 ) (3,996,905 ) (13,692,944 ) (9,836,670 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 22,232,799 15,093,147 22,075,135 13,369,462 Net loss per share attributable to common stockholders, basic and diluted $ (0.24 ) (0.26 ) (0.62 ) (0.74 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Options to purchase common stock 3,251,644 2,229,271 3,251,644 2,229,271 Warrants to purchase common stock, in connection with April 2023 financing 68,809 2,468,809 68,809 2,468,809 Warrants to purchase common stock, in connection with November 2023 financing 11,610,166 — 11,610,166 — Warrants to purchase common stock 196,816 233,460 196,816 233,460 Total potential shares 15,127,435 4,931,540 15,127,435 4,931,540

Income Taxes

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2024
Income Taxes [Abstract]
Income Taxes	(15) Income Taxes The effective tax rate of 0% for the three and nine months ended September 30, 2024 and 2023 was lower than the statutory rate due to the Company remaining in a full valuation allowance position.

Subsequent Events

Subsequent Events	9 Months Ended
Subsequent Events	Sep. 30, 2024
Subsequent Events [Abstract]
Subsequent Events	(16) Subsequent Events In October 2024, the Company sold 665,669 shares under the at-the-market facility, resulting in gross cash proceeds of $900,317.

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 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)	9 Months Ended
Organization, Nature of Business, and Liquidity (Policies)	Sep. 30, 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 for four products: FemaSeed, FemVue, FemCerv® and FemCath®. 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. 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 for diagnosis of cervical cancer 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. I ®, a controlled contrast generating device. FemBloc®, the Company’s solution for permanent birth control, is based on the Company’s platform technology for delivery and in June 2023 Femasys received FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, non-hormonal in-office solution for permanent birth control in a pivotal clinical trial. In August 2023 Femasys announced the initiation of enrollment in the FINALE [Prospective Multi-Center Trial for FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control] pivotal trial designed to evaluate the safety and efficacy of FemBloc. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have relied on FemBloc for one year for permanent birth control. In addition, the study is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for permanent birth control for one year. Follow-up will continue annually for five years post-market.
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 September 30, 2024, the Company had cash and cash equivalents of $7,611,210. 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 FemaSeed and For the nine months ended September $13,692,944. The Company expects such losses to increase over the next few years as the Company advances FemBloc through clinical development if and until FDA approval is received and is available to be marketed. The financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of September
Recently Issued Accounting Pronouncements Adopted and Not Yet Adopted	Recently Issued Accounting Pronouncements I n November 2023, the FASB issued ASU No. 2023-07, 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)	9 Months Ended
Inventories (Tables)	Sep. 30, 2024
Inventories [Abstract]
Inventory Stated at Cost, Net of Reserve	Inventory stated at cost, net of reserve, consisted of the following: September 30 December 31, 2024 2023 Materials $ 1,043,045 367,934 Work in progress 509,217 128,993 Finished goods 385,408 170,191 Inventory, net $ 1,937,670 667,118

Accrued Expenses (Tables)

Accrued Expenses (Tables)	9 Months Ended
Accrued Expenses (Tables)	Sep. 30, 2024
Accrued Expenses [Abstract]
Accrued Expenses	Accrued expenses consisted of the following: September 30, December 31, 2024 2023 Accrued interest $ 352,775 — Clinical trial costs 350,208 276,141 Incentive and other compensation costs 297,897 1,082,606 Director fees 70,000 60,210 Franchise taxes 3,150 12,160 Other 53,615 13,179 Accrued expenses $ 1,127,645 1,444,296

Clinical Holdback (Tables)

Clinical Holdback (Tables)	9 Months Ended
Clinical Holdback (Tables)	Sep. 30, 2024
Clinical Holdback [Abstract]
Clinical Holdback Liability	The following table shows the activity within the clinical holdback liability accounts for the nine months ended September 30, 2024: Balance at December 31, 2023 $ 120,235 Clinical holdback retained 14,465 Clinical holdback paid (6,449 ) Balance at September 30, 2024 $ 128,251 Less: clinical holdback - current portion (92,170 ) Clinical holdback - long-term portion $ 36,081

Revenue Recognition (Tables)

Revenue Recognition (Tables)	9 Months Ended
Revenue Recognition (Tables)	Sep. 30, 2024
Revenue Recognition [Abstract]
Sales by Geographic Region	The following table summarizes our sales by geographic region as follows: Three Months Ended September 30, Nine Months Ended September 30, Primary geographical markets 2024 2023 2024 2023 U.S. $ 262,458 244,361 755,082 800,814 International 292,450 — 292,450 58,045 Total $ 554,908 244,361 1,047,532 858,859

Equity Incentive Plans and Wa_2

Equity Incentive Plans and Warrants (Tables)	9 Months Ended
Equity Incentive Plans and Warrants (Tables)	Sep. 30, 2024
Equity Incentive Plans and Warrants [Abstract]
Stock Option Plans Activity	Activity under the Company’s stock option plans for the nine months ended September 30, 2024 was as follows: Number of options Weighted average exercise price Outstanding at December 31, 2023 2,102,030 $ 2.00 Granted 1,259,421 1.07 Forfeited (359,807 ) 1.96 Outstanding at September 30, 2024 3,001,644 $ 1.61 Vested and exercisable at September 30 1,295,956 $ 2.36
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 September 30 Nine September 30 2024 2023 2024 2023 Research and development $ 49,800 79,561 114,437 131,812 Sales and marketing 18,895 623 43,659 (1,319 ) General and administrative 59,711 424,175 151,908 496,036 Total share-based compensation expense $ 128,406 504,359 310,004 626,529
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]
Valuation Assumptions	Options granted under our 2021 Stock Option Plan for the nine months ended September 30, 2024 to employees and nonemployees were 1,186,521 and 72,900, respectively and the weighted average exercise prices were $1.06 and $1.13, respectively. The weighted-average fair values of the options granted to employees and nonemployees were $0.91 and $0.93, respectively and were estimated using the following Black-Scholes assumptions: Employee Nonemployee Expected term (in years) 6.25 5.36 Risk‑free interest rate 4.05 % 4.09 % Dividend yield — % — % Expected volatility 110.29 % 111.97 %
Inducement Grants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Valuation 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)	9 Months Ended
	Sep. 30, 2024
Net Loss per Share Attributable to Common Stockholders [Abstract]
Computation of Basic and Diluted Net Loss Per Share	The following ta ble sets forth the computation of t Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Net loss attributable to common stockholders, basic & diluted $ (5,408,860 ) (3,996,905 ) (13,692,944 ) (9,836,670 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 22,232,799 15,093,147 22,075,135 13,369,462 Net loss per share attributable to common stockholders, basic and diluted $ (0.24 ) (0.26 ) (0.62 ) (0.74 )
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: Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Options to purchase common stock 3,251,644 2,229,271 3,251,644 2,229,271 Warrants to purchase common stock, in connection with April 2023 financing 68,809 2,468,809 68,809 2,468,809 Warrants to purchase common stock, in connection with November 2023 financing 11,610,166 — 11,610,166 — Warrants to purchase common stock 196,816 233,460 196,816 233,460 Total potential shares 15,127,435 4,931,540 15,127,435 4,931,540

Organization, Nature of Busin_3

Organization, Nature of Business, and Liquidity (Details)	3 Months Ended		9 Months Ended
Organization, Nature of Business, and Liquidity (Details)	Sep. 30, 2024 USD ($) Women	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) Product Women Segment	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)
Organization and Nature of Business [Abstract]
Number of operating segments \| Segment			1
Number of products that received EU MDR and CE certification marks \| Product			4
Number of women using FemBloc for permanent birth control \| Women	401		401
Duration of time women used FemBloc as permanent birth control			1 year
Number of women enrolled for a clinical readout \| Women			50
Minimum number of subjects needed for Interim analysis of clinical data endpoints \| Women			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 \| $	$ 7,611,210		$ 7,611,210		$ 21,716,077
Net loss \| $	(5,408,860)	$ (3,996,905)	(13,692,944)	$ (9,836,670)
Accumulated deficit \| $	$ (122,074,573)		$ (122,074,573)		$ (108,381,629)

Cash and Cash Equivalents (Deta

Cash and Cash Equivalents (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Level 1 [Member] \| Money Market Funds [Member]
Assets, Fair Value Disclosure [Abstract]
Cash and cash equivalent	$ 6,809,936	$ 21,278,895

Inventories (Details)

Inventories (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Inventories [Abstract]
Materials	$ 1,043,045	$ 367,934
Work in progress	509,217	128,993
Finished goods	385,408	170,191
Inventory, net	$ 1,937,670	$ 667,118

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Accrued Expenses [Abstract]
Accrued interest	$ 352,775	$ 0
Clinical trail costs	350,208	276,141
Incentive and other compensation costs	297,897	1,082,606
Director fees	70,000	60,210
Franchise taxes	3,150	12,160
Other	53,615	13,179
Accrued expenses	$ 1,127,645	$ 1,444,296

Clinical Holdback (Details)

Clinical Holdback (Details) - USD ($)	9 Months Ended
Clinical Holdback (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Clinical Holdback Liability [Roll Forward]
Balance	$ 120,235
Clinical holdback retained	14,465
Clinical holdback paid	(6,449)
Balance	128,251
Less: clinical holdback - current portion	(92,170)	$ (65,300)
Clinical holdback - long-term portion	$ 36,081	$ 54,935

Revenue Recognition (Details)

Revenue Recognition (Details) - USD ($)	3 Months Ended		9 Months Ended
Revenue Recognition (Details) - USD ($)	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenue Recognition [Abstract]
Revenue recognized from performance obligations in prior periods	$ 0	$ 0	$ 0	$ 0
Percentage of restocking fee			30%
Primary Geographical Markets [Abstract]
Sales	554,908	244,361	$ 1,047,532	858,859
U.S. [Member]
Primary Geographical Markets [Abstract]
Sales	262,458	244,361	755,082	800,814
International [Member]
Primary Geographical Markets [Abstract]
Sales	$ 292,450	$ 0	$ 292,450	$ 58,045
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 ($)	1 Months Ended	3 Months Ended		9 Months Ended
Notes Payable (Details) - USD ($)	Jul. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Notes Payable [Abstract]
Down payments				$ 0	$ 327,006
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		$ 0
Interest expense on loan		$ 0	$ 9,317	$ 0	$ 9,317

Convertible Notes with Warran_2

Convertible Notes with Warrants (November 2023 Financing), Summary (Details) - November 2023 Financing [Member] - USD ($)		9 Months Ended
	Nov. 21, 2023	Sep. 30, 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_3

Convertible Notes with Warrants (November 2023 Financing), Warrants (Details) - November 2023 Financing [Member] - USD ($)		9 Months Ended
	Nov. 21, 2023	Sep. 30, 2024
Warrants [Abstract]
Consecutive trading days		10 days
Daily dollar trading volume of common stock exceeds per day	$ 1,000,000
Series A Warrants [Member]
Warrants [Abstract]
Warrants term		5 years
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
Series B Warrants [Member]
Warrants [Abstract]
Warrants term		1 year
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

Convertible Notes with Warran_4

Convertible Notes with Warrants (November 2023 Financing), Convertible Notes Payable (Details) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Convertible Notes [Abstract]
Amortization of debt discount and issuance costs		$ 854,902	$ 0
Convertible Notes Payable [Abstract]
Accrued and unpaid interest	$ 352,775	352,775		$ 0
November 2023 Financing [Member] \| Convertible Notes [Member]
Convertible Notes [Abstract]
Interest expense	413,290	1,163,153
Coupon interest expense	102,750	308,250
Amortization of debt discount and issuance costs	310,540	854,902
Convertible Notes Payable [Abstract]
Notes principal balance	6,850,000	6,850,000		6,850,000
Accrued and unpaid interest	352,775	352,775		44,525
Unamortized discount and debt issuance costs	1,781,444	1,781,444		$ 2,636,346
Convertible note, fair value	$ 6,399,810	$ 6,399,810

Stockholders' Equity (Details)

Stockholders' Equity (Details) - USD ($)		1 Months Ended			9 Months Ended
Stockholders' Equity (Details) - USD ($)	Apr. 20, 2023	Oct. 31, 2023	Sep. 30, 2023	Apr. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Jul. 01, 2022
Stockholders Equity [Abstract]
Common stock sold (in shares)	1,318,000
Proceeds from Issuance of Common Stock					$ 1,021,994	$ 3,373
Gross proceeds from offering	$ 3,899,813			$ 3,899,813
Placement agent fees expenses and offering expenses				$ 547,764
Common stock, outstanding (in shares)					22,232,799		21,657,381
Dividends declared or paid					$ 0
Cash proceeds from warrants exercised					$ 0	$ 1,059,975
Maximum [Member]
Stockholders Equity [Abstract]
Authorized offering amount of securities								$ 150,000,000
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
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
Placement Agent Warrants [Member] \| Maximum [Member]
Stockholders Equity [Abstract]
Warrants issued to purchase common stock (in shares)				191,803
Equity Distribution Agreement [Member]
Stockholders Equity [Abstract]
Common stock sold (in shares)					3,900,000
Proceeds from Issuance of Common Stock					$ 8,700,000
Equity Distribution Agreement [Member] \| Maximum [Member]
Stockholders Equity [Abstract]
Common stock authorized value to be issued by Sales Agent		$ 16,700,000
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 Plans, Activity (Details) - 2021 Stock Option Plan [Member]	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Number of Options [Roll Forward]
Beginning balance (in shares) \| shares	2,102,030
Granted (in shares) \| shares	1,259,421
Forfeited (in shares) \| shares	(359,807)
Ending balance (in shares) \| shares	3,001,644
Weighted Average Exercise Price [Abstract]
Beginning balance (in dollars per share) \| $ / shares	$ 2
Granted (in dollars per share) \| $ / shares	1.07
Forfeited (in dollars per share) \| $ / shares	1.96
Ending balance (in dollars per share) \| $ / shares	$ 1.61
Options vested and exercisable [Abstract]
Options vested and exercisable, Number of options vested (in shares) \| shares	1,295,956
Options vested and exercisable, Exercise price (in dollars per share) \| $ / shares	$ 2.36
Estimated Fair Value Assumptions [Abstract]
Options exercised (in shares) \| shares	0
Common stock reserved for issuance (in shares) \| shares	596,236
Employees [Member]
Number of Options [Roll Forward]
Granted (in shares) \| shares	1,186,521
Weighted Average Exercise Price [Abstract]
Granted (in dollars per share) \| $ / shares	$ 1.06
Options vested and exercisable [Abstract]
Weighted-average fair values of options granted (in dollars per share) \| $ / shares	$ 0.91
Estimated Fair Value Assumptions [Abstract]
Expected term (in years)	6 years 3 months
Risk free interest rate	4.05%
Dividend yield	0%
Expected volatility	110.29%
Nonemployee [Member]
Number of Options [Roll Forward]
Granted (in shares) \| shares	72,900
Weighted Average Exercise Price [Abstract]
Granted (in dollars per share) \| $ / shares	$ 1.13
Options vested and exercisable [Abstract]
Weighted-average fair values of options granted (in dollars per share) \| $ / shares	$ 0.93
Estimated Fair Value Assumptions [Abstract]
Expected term (in years)	5 years 4 months 9 days
Risk free interest rate	4.09%
Dividend yield	0%
Expected volatility	111.97%

Equity Incentive Plans and Wa_4

Equity Incentive Plans and Warrants, Inducement Grants (Details) - Inducement Grants [Member] - $ / shares	Feb. 12, 2024	Sep. 30, 2024
Inducement Grants [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		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based Compensation Expense [Abstract]
Share-based compensation expense	$ 128,406	$ 504,359	$ 310,004	$ 626,529
Share-based compensation expense expected to be recognized for employees and nonemployees	1,487,486		1,487,486
Compensation expense to be recognized upon achieving certain performance condition			155,222
Unrecognized expenses	1,332,264		$ 1,332,264
Weighted-average period over which unrecognized compensation is expected to be recognized			3 years
Research and Development [Member]
Share-based Compensation Expense [Abstract]
Share-based compensation expense	49,800	79,561	$ 114,437	131,812
Sales and Marketing [Member]
Share-based Compensation Expense [Abstract]
Share-based compensation expense	18,895	623	43,659	(1,319)
General and Administrative [Member]
Share-based Compensation Expense [Abstract]
Share-based compensation expense	$ 59,711	$ 424,175	$ 151,908	$ 496,036

Equity Incentive Plans and Wa_6

Equity Incentive Plans and Warrants, Employee Stock Purchase Plan (Details) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023
Employee Stock Purchase Plan [Abstract]
Stock issued, fair value	$ 0	$ 10,390	$ 1,697
Employee Stock Purchase Plan [Member]
Employee Stock Purchase Plan [Abstract]
Stock issued (in shares)		12,081	3,858
Stock issued, fair value		$ 10,390	$ 1,697
Common stock reserved for issuance (in shares)	591,437	591,437

Equity Incentive Plans and Wa_7

Equity Incentive Plans and Warrants, April 2023 Financing (Details) - USD ($)		1 Months Ended			9 Months Ended
	Apr. 20, 2023	Oct. 31, 2023	Sep. 30, 2023	Apr. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Warrants [Abstract]
Issuance and sale of common stock (in shares)	1,318,000
Gross proceeds from offering	$ 3,899,813			$ 3,899,813
Transaction costs	547,764				$ 0	$ 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
Cash proceeds from warrants exercised					$ 0	$ 1,059,975
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
Related-Party Transactions (Details) $ in Millions	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		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Net Income (Loss) Available to Common Stockholders, Basic [Abstract]
Net loss attributable to common stockholders, basic	$ (5,408,860)	$ (3,996,905)	$ (13,692,944)	$ (9,836,670)
Net loss attributable to common stockholders, diluted	$ (5,408,860)	$ (3,996,905)	$ (13,692,944)	$ (9,836,670)
Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic (in shares)	22,232,799	15,093,147	22,075,135	13,369,462
Weighted average number of shares used in computing net loss per share attributable to common stockholders, diluted (in shares)	22,232,799	15,093,147	22,075,135	13,369,462
Net loss per share attributable to common stockholders, basic (in dollars per share)	$ (0.24)	$ (0.26)	$ (0.62)	$ (0.74)
Net loss per share attributable to common stockholders, diluted (in dollars per share)	$ (0.24)	$ (0.26)	$ (0.62)	$ (0.74)
Weighted Average Number of Shares Outstanding [Abstract]
Options to purchase common stock (in shares)	3,251,644	2,229,271	3,251,644	2,229,271
Warrants to purchase common stock (in shares)	196,816	233,460	196,816	233,460
Total potential shares (in shares)	15,127,435	4,931,540	15,127,435	4,931,540
April 2023 Financing [Member]
Weighted Average Number of Shares Outstanding [Abstract]
Warrants to purchase common stock in connection financing (in shares)	68,809	2,468,809	68,809	2,468,809
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	11,610,166	0

Income Taxes (Details)

Income Taxes (Details)	3 Months Ended		9 Months Ended
Income Taxes (Details)	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Effective Income Tax Rate Reconciliation, Percent [Abstract]
Effective tax rate	0%	0%	0%	0%

Subsequent Events (Details)

Subsequent Events (Details) - USD ($)		1 Months Ended
Subsequent Events (Details) - USD ($)	Apr. 20, 2023	Oct. 31, 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)		665,669
Gross cash proceeds from offering		$ 900,317