Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 13, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
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 | |
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 | |
Title of 12(b) Security | Common stock, $0.001 par value | |
Trading Symbol | FEMY | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 21,649,623 |
Balance Sheets
Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,692,435 | $ 12,961,936 |
Accounts receivable, net | 103,556 | 77,470 |
Inventory, net | 602,668 | 436,723 |
Other current assets | 826,373 | 655,362 |
Total current assets | 10,225,032 | 14,131,491 |
Property and equipment, at cost: | ||
Leasehold improvements | 1,195,637 | 1,195,637 |
Office equipment | 99,344 | 99,344 |
Furniture and fixtures | 419,303 | 419,303 |
Machinery and equipment | 2,645,609 | 2,572,243 |
Construction in progress | 394,957 | 413,843 |
Property and equipment, gross | 4,754,850 | 4,700,370 |
Less accumulated depreciation | (3,594,300) | (3,217,319) |
Net property and equipment | 1,160,550 | 1,483,051 |
Long-term assets: | ||
Lease right-of-use assets, net | 2,530,571 | 319,557 |
Intangible assets, net of accumulated amortization | 388 | 3,294 |
Other long-term assets | 936,996 | 958,177 |
Total long-term assets | 3,467,955 | 1,281,028 |
Total assets | 14,853,537 | 16,895,570 |
Current liabilities: | ||
Accounts payable | 851,877 | 510,758 |
Accrued expenses | 569,442 | 456,714 |
Note payable | 283,334 | 141,298 |
Clinical holdback - current portion | 72,075 | 45,206 |
Lease liabilities - current portion | 410,219 | 373,833 |
Total current liabilities | 2,186,947 | 1,527,809 |
Long-term liabilities: | ||
Clinical holdback - long-term portion | 54,019 | 96,658 |
Lease liabilities - long-term portion | 2,168,969 | 28,584 |
Total long-term liabilities | 2,222,988 | 125,242 |
Total liabilities | 4,409,935 | 1,653,051 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $.001 par, 200,000,000 authorized, 16,110,092 shares issued and 15,992,869 outstanding as of September 30, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022 | 16,110 | 11,987 |
Treasury stock, 117,223 shares | (60,000) | (60,000) |
Warrants | 1,581,608 | 567,972 |
Additional paid-in-capital | 112,877,059 | 108,857,065 |
Accumulated deficit | (103,971,175) | (94,134,505) |
Total stockholders' equity | 10,443,602 | 15,242,519 |
Total liabilities and stockholders' equity | $ 14,853,537 | $ 16,895,570 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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) | 16,110,092 | 11,986,927 |
Common stock, outstanding (in shares) | 15,992,869 | 11,869,704 |
Treasury stock, shares (in shares) | 117,223 | 117,223 |
Statements of Comprehensive Los
Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statements of Comprehensive Loss [Abstract] | ||||
Sales | $ 244,361 | $ 347,456 | $ 858,859 | $ 971,974 |
Cost of sales | 86,186 | 131,451 | 301,775 | 356,479 |
Gross margin | 158,175 | 216,005 | 557,084 | 615,495 |
Operating expenses: | ||||
Research and development | 2,072,830 | 1,648,160 | 5,137,441 | 4,542,147 |
Sales and marketing | 70,883 | 90,374 | 444,678 | 222,414 |
General and administrative | 1,970,408 | 1,395,063 | 4,642,182 | 4,024,356 |
Depreciation and amortization | 125,318 | 139,597 | 391,683 | 426,480 |
Total operating expenses | 4,239,439 | 3,273,194 | 10,615,984 | 9,215,397 |
Loss from operations | (4,081,264) | (3,057,189) | (10,058,900) | (8,599,902) |
Other income (expense): | ||||
Interest income | 92,392 | 80,373 | 232,133 | 109,572 |
Interest expense | (8,033) | (6,005) | (9,903) | (9,622) |
Other expense | 0 | (22) | 0 | (22) |
Other income (expense), net | 84,359 | 74,346 | 222,230 | 99,928 |
Net loss | (3,996,905) | (2,982,843) | (9,836,670) | (8,499,974) |
Net loss attributable to common stockholders, basic | (3,996,905) | (2,982,843) | (9,836,670) | (8,499,974) |
Net loss attributable to common stockholders, diluted | $ (3,996,905) | $ (2,982,843) | $ (9,836,670) | $ (8,499,974) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.26) | $ (0.25) | $ (0.74) | $ (0.72) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.26) | $ (0.25) | $ (0.74) | $ (0.72) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 15,093,147 | 11,813,610 | 13,369,462 | 11,810,289 |
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 15,093,147 | 11,813,610 | 13,369,462 | 11,810,289 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Treasury Stock [Member] | Warrants [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2021 | $ 11,921 | $ (60,000) | $ 702,492 | $ 108,418,304 | $ (82,740,335) | $ 26,332,382 |
Balance (in shares) at Dec. 31, 2021 | 11,921,388 | |||||
Treasury stock, shares (in shares) at Dec. 31, 2021 | 117,223 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Expiration of Warrant | (134,520) | 134,520 | 0 | |||
Issuance of common stock for cash upon exercise of options | $ 10 | $ 0 | 0 | 16,141 | 0 | 16,151 |
Issuance of common stock for cash upon exercise of options (in shares) | 9,445 | 0 | ||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 158,288 | 0 | 158,288 |
Net loss | 0 | $ 0 | 0 | 0 | (8,499,974) | (8,499,974) |
Treasury stock, shares (in shares) at Sep. 30, 2022 | 117,223 | |||||
Balance at Sep. 30, 2022 | $ 11,931 | $ (60,000) | 567,972 | 108,727,253 | (91,240,309) | 18,006,847 |
Balance (in shares) at Sep. 30, 2022 | 11,930,833 | |||||
Balance at Jun. 30, 2022 | $ 11,931 | $ (60,000) | 567,972 | 108,675,491 | (88,257,466) | 20,937,928 |
Balance (in shares) at Jun. 30, 2022 | 11,930,833 | |||||
Treasury stock, shares (in shares) at Jun. 30, 2022 | 117,223 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 51,762 | 0 | 51,762 |
Net loss | 0 | $ 0 | 0 | 0 | (2,982,843) | (2,982,843) |
Treasury stock, shares (in shares) at Sep. 30, 2022 | 117,223 | |||||
Balance at Sep. 30, 2022 | $ 11,931 | $ (60,000) | 567,972 | 108,727,253 | (91,240,309) | 18,006,847 |
Balance (in shares) at Sep. 30, 2022 | 11,930,833 | |||||
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 | 11,986,927 | ||||
Treasury stock, shares (in shares) at Dec. 31, 2022 | 117,223 | 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 | 0 | ||||
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 | |||||
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, shares (in shares) at Sep. 30, 2023 | 117,223 | 117,223 | ||||
Balance at Sep. 30, 2023 | $ 16,110 | $ (60,000) | 1,581,608 | 112,877,059 | (103,971,175) | $ 10,443,602 |
Balance (in shares) at Sep. 30, 2023 | 16,110,092 | 16,110,092 | ||||
Balance at Jun. 30, 2023 | $ 15,190 | $ (60,000) | 1,918,103 | 110,977,150 | (99,974,270) | $ 12,876,173 |
Balance (in shares) at Jun. 30, 2023 | 15,190,376 | |||||
Treasury stock, shares (in shares) at Jun. 30, 2023 | 117,223 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Exercise of common warrants | $ 920 | $ 0 | (336,495) | 1,395,550 | 0 | 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, shares (in shares) at Sep. 30, 2023 | 117,223 | 117,223 | ||||
Balance at Sep. 30, 2023 | $ 16,110 | $ (60,000) | $ 1,581,608 | $ 112,877,059 | $ (103,971,175) | $ 10,443,602 |
Balance (in shares) at Sep. 30, 2023 | 16,110,092 | 16,110,092 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (9,836,670) | $ (8,499,974) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 388,777 | 407,146 |
Amortization | 2,906 | 19,334 |
Amortization of right-of-use assets | 274,158 | 249,972 |
Inventory reserve | 4,972 | 3,800 |
Loss on disposal of assets | 44,538 | 0 |
Share-based compensation expense | 626,529 | 158,288 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (26,086) | (98,872) |
Inventory | (170,917) | (138,666) |
Other assets | 313,154 | 359,307 |
Accounts payable | 341,119 | (49,449) |
Accrued expenses | 112,728 | 45,828 |
Lease liabilities | (304,004) | (290,104) |
Other liabilities | (15,770) | (30,696) |
Net cash used in operating activities | (8,244,566) | (7,864,086) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (99,018) | (313,598) |
Net cash used in investing activities | (99,018) | (313,598) |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock and warrants in April 2023 Financing | 3,899,813 | 0 |
Equity issuance costs | (547,764) | 0 |
Proceeds from exercise of pre-funded warrants | 188 | 0 |
Proceeds from exercise of common warrants | 1,059,975 | 0 |
Proceeds from common stock issued through ESPP and exercised options | 1,697 | 16,151 |
Net proceeds from issuance of common stock in connection with at-the-market offering | 3,373 | 0 |
Payments of deferred offering costs | 0 | (232,845) |
Repayment of note payable | (327,006) | (365,926) |
Payments under lease obligations | (16,193) | (17,075) |
Net cash provided by (used in) financing activities | 4,074,083 | (599,695) |
Net change in cash and cash equivalents | (4,269,501) | (8,777,379) |
Cash and cash equivalents: | ||
Beginning of period | 12,961,936 | 24,783,029 |
End of period | 8,692,435 | 16,005,650 |
Cash paid for: | ||
Interest | 9,903 | 9,622 |
Income taxes | 4,550 | 5,050 |
Non-cash investing and financing activities: | ||
Right-of-use asset obtained in exchange for a lease liability | 2,496,968 | 0 |
Property and equipment costs included in accounts payable | 0 | 23,037 |
Commissions and deferred offering costs relating to proceeds from issuance of common stock | 6,163 | 0 |
Prepaid insurance financed with promissory notes | $ 283,334 | $ 280,577 |
Organization, Nature of Busines
Organization, Nature of Business, and Liquidity | 9 Months Ended |
Sep. 30, 2023 | |
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 biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative therapeutic and diagnostic products. The Company currently operates as one segment with an initial focus on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility 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. FemBloc® (FemBloc), the Company’s solution for permanent birth control, is based on the Company’s non-surgical platform technology. In June 2023 the Company received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the pivotal clinical trial of FemBloc. In July 2023 the Company announced the notice of allowance for a new U.S. patent application covering use of FemBloc for female permanent birth control. In August 2023 the Company announced the initiation of enrollment for the pivotal clinical trial of FemBloc. FemaSeed® (FemaSeed), a solution which enables intratubal artificial insemination to provide a lower cost option to in vitro fertilization methods, received approval in April 2021 from the FDA on its IDE and the clinical trial was initiated in July 2021. An updated trial design received approval in October 2022 from the FDA and the trial enrollment is ongoing. In April 2023 the Company received approval to sell FemaSeed in Canada. In September 2023 the Company announced 510(k) clearance from the FDA for FemaSeed for intratubal insemination. FemVue® (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® (FemChec) allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success) and is being studied as part of the FemBloc pivotal trial. FemCath® (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. FemCerv® (FemCerv) is an alternative for the diagnosis of cervical cancer by obtaining a comprehensive tissue sample with minimal contamination of the endocervical canal, and is approved for sale in the U.S and Canada. In August 2023 the Company announced it had obtained a Medical Device Establishment License from Health Canada allowing the Company to directly sell its four products, FemaSeed®, FemVue®, FemCath® and FemCerv®, in Canada. Basis of Presentation The Company has prepared the accompanying 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 financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2022 included in our Annual Report on Form 10K filed with the SEC on March 30, 2023 (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. The most significant estimates used in these financial statements include the valuation of stock options, warrants, useful lives of property and equipment and intangible assets. 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, 2023, the Company had cash and cash equivalents of $8,692,435. 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 nine months ended September 30, 2023, the Company generated a net loss of $9,836,670. 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 in the United States. The Company believes that its cash and cash equivalents as of September 30, 2023 and cash received subsequent to quarter end (see Note 13, Subsequent Events Recently Issued Accounting Pronouncements – Recently Adopted On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the Financial Accounting Standards Board (FASB) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets, which are not measured at fair value through net income. Under legacy standards, we recognize an impairment of receivables when it was probable that a loss had been incurred. Under the new standard, we are required to recognize estimated credit losses expected to occur over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions. The guidance is effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this new guidance did not have a material impact on the Company’s financial statements and footnote disclosures (unaudited). Recently Issued Accounting Pronouncements – Not Yet Adopted No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s financial statements. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 9 Months Ended |
Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | (2) Cash and Cash Equivalents As of September 30, 2023 and December 31, 2022, money market funds included in cash and cash equivalents on the balance sheets were $7,330,371 and $12,553,557, 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 |
Sep. 30, 2023 | |
Inventories [Abstract] | |
Inventories | (3) Inventories Inventory stated at cost, net of reserve, consisted of the following: September 30, December 31, 2023 2022 Materials $ 361,569 244,498 Work in progress 51,358 100,453 Finished goods 189,741 91,772 Inventory, net $ 602,668 436,723 The FemVue reserve for slow moving, obsolete, or unusable inventories was as of September 30, 2023 and December 31, 2022, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | (4) Accrued Expenses Accrued expenses consisted of the following: September 30, December 31, 2023 2022 Clinical trial costs $ 313,029 333,440 Compensation costs 155,192 85,191 Franchise taxes — 26,886 Director fees 90,000 — Other 11,221 11,197 Accrued expenses $ 569,442 456,714 |
Clinical Holdback
Clinical Holdback | 9 Months Ended |
Sep. 30, 2023 | |
Clinical Holdback [Abstract] | |
Clinical Holdback | (5) Clinical Holdback The following table shows the activity within the clinical holdback liability accounts for the nine months ended September 30, 2023: Balance at December 31, 2022 $ 141,864 Clinical holdback retained 4,529 Clinical holdback paid (20,299 ) Balance at September 30 2023 $ 126,094 Less: clinical holdback - current portion (72,075 ) Clinical holdback - long-term portion $ 54,019 |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2023 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | (6) 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, 2023 and 2022, 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, 2023 or 2022. 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 September 30, Nine Months Ended September 30, Primary geographical markets 2023 2022 2023 2022 U.S. $ 244,361 289,642 800,814 856,115 International — 57,814 58,045 115,859 Total $ 244,361 347,456 858,859 971,974 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | (7) 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 30, 2023 and December 31, 2022. |
Notes Payable
Notes Payable | 9 Months Ended |
Sep. 30, 2023 | |
Notes Payable [Abstract] | |
Notes Payable | (8) 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 is 8.587% and the monthly installment is $48,423, which represents principal and interest. As of September 30, 2023 and December 31, 2022, the principal balance on the remaining AFCO promissory notes was $283,334 and $141,298, respectively and is included in Notes payable in the accompanying balance sheets. Interest expense in connection with the AFCO promissory notes was $7,998 and $5,352 for the three months ended September 30, 2023 and 2022, respectively. Interest expense was $9,317 and $7,235 for the nine months ended September 30, 2023 and 2022, respectively . |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | (9) Leases Operating Lease April 2029 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | (10) Stockholders’ Equity In July 2022, the Company 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 the Company may offer and sell shares of common stock having an aggregate offering price of up to $8,800,000 from time to time through the Sales Agent pursuant to the Prospectus. For the nine months ended September 30, 2023, 2,869 shares of common stock were sold under the Equity Distribution Agreement. In April 2023, the Company suspended its at-the-market facility with the Sales Agent, which was subsequently reinstated in October 2023 (see Note 13, Subsequent Events 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 September 30, 2023, the Company had 15,992,869 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 |
Sep. 30, 2023 | |
Equity Incentive Plans and Warrants [Abstract] | |
Equity Incentive Plans and Warrants | (11) 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, 2023 was as follows: Number of options Weighted average exercise price Outstanding at December 31, 2022 931,550 $ 3.97 Granted 5,000 1.18 Forfeited (50,055 ) 1.87 Outstanding at March 31, 2023 886,495 $ 4.07 Granted 153,200 0.75 Forfeited (20,024 ) 3.94 Outstanding at June 30, 2023 1,019,671 $ 3.57 Granted 1,064,800 0.49 Forfeited (5,200 ) 1.25 Outstanding at September 30, 2023 2,079,271 $ 2.00 Vested and exercisable at September 30 1,217,298 $ 2.62 Options granted under our 2021 Stock Option Plan for the nine months ended September 30, 2023 to employees and nonemployees were 1,150,000 and 73,000, respectively and the weighted average exercise prices were $0.52 and $0.64, respectively. The weighted-average fair values of the options granted to employees and nonemployees were $0.42 and $0.51, respectively and were estimated using the following Black-Scholes assumptions: Employee Nonemployee Expected term (in years) 5.60 5.49 Risk‑free interest rate 4.06 % 3.96 % Dividend yield — % — % Expected volatility 105.14 % 106.58 % No options were exercised for the nine months ended September 30, 2023 under our stock option plans. As of September 30, 2023, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was 652,314. (b) Inducement Grants For the nine months ended September 30, 2023, no inducement awards were granted. As of September 30, 2023 (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 statement of comprehensive loss: Three Months Ended September 30 Nine September 30 2023 2022 2023 2022 Research and development $ 79,561 10,820 131,812 73,395 Sales and marketing 623 1,515 (1,319 ) 3,857 General and administrative 424,175 39,427 496,036 81,036 Total share-based compensation expense $ 504,359 51,762 626,529 158,288 As September 30, 2023 (d) Employee Stock Purchase Plan (ESPP) For the nine months ended September 30, 2023 September 30, 2023 (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 10, 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 2023, 796,722 common warrants and 122,994 placement agent warrants were exercised for cash proceeds of $1,059,975 |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | (12) 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, 2023 2022 2023 2022 Net loss attributable to common stockholders, basic & diluted $ (3,996,905 ) (2,982,843 ) (9,836,670 ) (8,499,974 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 15,093,147 11,813,610 13,369,462 11,810,289 Net loss per share attributable to common stockholders, basic and diluted $ (0.26 ) (0.25 ) (0.74 ) (0.72 ) 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, 2023 2022 2023 2022 Options to purchase common stock 2,229,271 1,071,573 2,229,271 1,071,573 Warrants to purchase common stock, in connection with April 2023 financing 2,468,809 — 2,468,809 — Warrants to purchase common stock 233,460 233,460 233,460 233,460 Total potential shares 4,931,540 1,305,033 4,931,540 1,305,033 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | (13) Subsequent Events In October 2023, 2,400,000 common warrants were exercised for cash proceeds of $2,628,000. In October 2023, the Company reinstated the at-the-market agreement and authorized the Sales Agent to sell up to $16.7 million shares at current market prices until all shares are sold. In October 2023, the Company sold 3,256,754 shares under this facility, resulting in gross cash proceeds of $7,661,587 . |
Organization, Nature of Busin_2
Organization, Nature of Business, and Liquidity (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
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 biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative therapeutic and diagnostic products. The Company currently operates as one segment with an initial focus on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility 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. FemBloc® (FemBloc), the Company’s solution for permanent birth control, is based on the Company’s non-surgical platform technology. In June 2023 the Company received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the pivotal clinical trial of FemBloc. In July 2023 the Company announced the notice of allowance for a new U.S. patent application covering use of FemBloc for female permanent birth control. In August 2023 the Company announced the initiation of enrollment for the pivotal clinical trial of FemBloc. FemaSeed® (FemaSeed), a solution which enables intratubal artificial insemination to provide a lower cost option to in vitro fertilization methods, received approval in April 2021 from the FDA on its IDE and the clinical trial was initiated in July 2021. An updated trial design received approval in October 2022 from the FDA and the trial enrollment is ongoing. In April 2023 the Company received approval to sell FemaSeed in Canada. In September 2023 the Company announced 510(k) clearance from the FDA for FemaSeed for intratubal insemination. FemVue® (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® (FemChec) allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success) and is being studied as part of the FemBloc pivotal trial. FemCath® (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. FemCerv® (FemCerv) is an alternative for the diagnosis of cervical cancer by obtaining a comprehensive tissue sample with minimal contamination of the endocervical canal, and is approved for sale in the U.S and Canada. In August 2023 the Company announced it had obtained a Medical Device Establishment License from Health Canada allowing the Company to directly sell its four products, FemaSeed®, FemVue®, FemCath® and FemCerv®, in Canada. |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying 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 financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2022 included in our Annual Report on Form 10K filed with the SEC on March 30, 2023 (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. The most significant estimates used in these financial statements include the valuation of stock options, warrants, useful lives of property and equipment and intangible assets. 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, 2023, the Company had cash and cash equivalents of $8,692,435. 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 nine months ended September 30, 2023, the Company generated a net loss of $9,836,670. 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 in the United States. The Company believes that its cash and cash equivalents as of September 30, 2023 and cash received subsequent to quarter end (see Note 13, Subsequent Events |
Recently Issued Accounting Pronouncements Adopted and Not Yet Adopted | Recently Issued Accounting Pronouncements – Recently Adopted On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the Financial Accounting Standards Board (FASB) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets, which are not measured at fair value through net income. Under legacy standards, we recognize an impairment of receivables when it was probable that a loss had been incurred. Under the new standard, we are required to recognize estimated credit losses expected to occur over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions. The guidance is effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this new guidance did not have a material impact on the Company’s financial statements and footnote disclosures (unaudited). Recently Issued Accounting Pronouncements – Not Yet Adopted 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 |
Sep. 30, 2023 | |
Inventories [Abstract] | |
Inventory Stated at Cost, Net of Reserve | Inventory stated at cost, net of reserve, consisted of the following: September 30, December 31, 2023 2022 Materials $ 361,569 244,498 Work in progress 51,358 100,453 Finished goods 189,741 91,772 Inventory, net $ 602,668 436,723 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following: September 30, December 31, 2023 2022 Clinical trial costs $ 313,029 333,440 Compensation costs 155,192 85,191 Franchise taxes — 26,886 Director fees 90,000 — Other 11,221 11,197 Accrued expenses $ 569,442 456,714 |
Clinical Holdback (Tables)
Clinical Holdback (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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, 2023: Balance at December 31, 2022 $ 141,864 Clinical holdback retained 4,529 Clinical holdback paid (20,299 ) Balance at September 30 2023 $ 126,094 Less: clinical holdback - current portion (72,075 ) Clinical holdback - long-term portion $ 54,019 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue Recognition [Abstract] | |
Sales by Geographic Region | The following table summarizes our sales, primarily from FemVue, by geographic region as follows: Three Months Ended September 30, Nine Months Ended September 30, Primary geographical markets 2023 2022 2023 2022 U.S. $ 244,361 289,642 800,814 856,115 International — 57,814 58,045 115,859 Total $ 244,361 347,456 858,859 971,974 |
Equity Incentive Plans and Wa_2
Equity Incentive Plans and Warrants (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity Incentive Plans and Warrants [Abstract] | |
Stock Option Plan Activity | Activity under the Company’s stock option plans for the nine months ended September 30, 2023 was as follows: Number of options Weighted average exercise price Outstanding at December 31, 2022 931,550 $ 3.97 Granted 5,000 1.18 Forfeited (50,055 ) 1.87 Outstanding at March 31, 2023 886,495 $ 4.07 Granted 153,200 0.75 Forfeited (20,024 ) 3.94 Outstanding at June 30, 2023 1,019,671 $ 3.57 Granted 1,064,800 0.49 Forfeited (5,200 ) 1.25 Outstanding at September 30, 2023 2,079,271 $ 2.00 Vested and exercisable at September 30 1,217,298 $ 2.62 |
Estimated Using Assumptions | Options granted under our 2021 Stock Option Plan for the nine months ended September 30, 2023 to employees and nonemployees were 1,150,000 and 73,000, respectively and the weighted average exercise prices were $0.52 and $0.64, respectively. The weighted-average fair values of the options granted to employees and nonemployees were $0.42 and $0.51, respectively and were estimated using the following Black-Scholes assumptions: Employee Nonemployee Expected term (in years) 5.60 5.49 Risk‑free interest rate 4.06 % 3.96 % Dividend yield — % — % Expected volatility 105.14 % 106.58 % |
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 statement of comprehensive loss: Three Months Ended September 30 Nine September 30 2023 2022 2023 2022 Research and development $ 79,561 10,820 131,812 73,395 Sales and marketing 623 1,515 (1,319 ) 3,857 General and administrative 424,175 39,427 496,036 81,036 Total share-based compensation expense $ 504,359 51,762 626,529 158,288 |
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 |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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, 2023 2022 2023 2022 Net loss attributable to common stockholders, basic & diluted $ (3,996,905 ) (2,982,843 ) (9,836,670 ) (8,499,974 ) Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 15,093,147 11,813,610 13,369,462 11,810,289 Net loss per share attributable to common stockholders, basic and diluted $ (0.26 ) (0.25 ) (0.74 ) (0.72 ) |
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, 2023 2022 2023 2022 Options to purchase common stock 2,229,271 1,071,573 2,229,271 1,071,573 Warrants to purchase common stock, in connection with April 2023 financing 2,468,809 — 2,468,809 — Warrants to purchase common stock 233,460 233,460 233,460 233,460 Total potential shares 4,931,540 1,305,033 4,931,540 1,305,033 |
Organization, Nature of Busin_3
Organization, Nature of Business, and Liquidity (Details) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) Segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Organization and Nature of Business [Abstract] | |||||
Number of operating segments | Segment | 1 | ||||
Liquidity [Abstract] | |||||
Cash and cash equivalents | $ 8,692,435 | $ 8,692,435 | $ 12,961,936 | ||
Net loss | $ (3,996,905) | $ (2,982,843) | $ (9,836,670) | $ (8,499,974) |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Level 1 [Member] | Money Market Funds [Member] | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalent | $ 7,330,371 | $ 12,553,557 |
Inventories (Details)
Inventories (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Inventories [Abstract] | ||
Materials | $ 361,569 | $ 244,498 |
Work in progress | 51,358 | 100,453 |
Finished goods | 189,741 | 91,772 |
Inventory, net | 602,668 | 436,723 |
Reserve for expired inventory | $ 3,560 | $ 2,103 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses [Abstract] | ||
Clinical trail costs | $ 313,029 | $ 333,440 |
Compensation costs | 155,192 | 85,191 |
Franchise taxes | 0 | 26,886 |
Director fees | 90,000 | 0 |
Other | 11,221 | 11,197 |
Accrued expenses | $ 569,442 | $ 456,714 |
Clinical Holdback (Details)
Clinical Holdback (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Clinical Holdback Liability [Roll Forward] | ||
Balance | $ 141,864 | |
Clinical holdback retained | 4,529 | |
Clinical holdback paid | (20,299) | |
Balance | 126,094 | |
Less: clinical holdback - current portion | (72,075) | $ (45,206) |
Clinical holdback - long-term portion | $ 54,019 | $ 96,658 |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
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 | 244,361 | 347,456 | $ 858,859 | 971,974 |
FemVue [Member] | ||||
Primary Geographical Markets [Abstract] | ||||
Sales | 244,361 | 347,456 | 858,859 | 971,974 |
FemVue [Member] | U.S. [Member] | ||||
Primary Geographical Markets [Abstract] | ||||
Sales | 244,361 | 289,642 | 800,814 | 856,115 |
FemVue [Member] | International [Member] | ||||
Primary Geographical Markets [Abstract] | ||||
Sales | $ 0 | $ 57,814 | $ 58,045 | $ 115,859 |
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 | |||
Jul. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Notes Payable [Abstract] | ||||||
Down payments | $ 327,006 | $ 365,926 | ||||
Note payable | $ 283,334 | $ 283,334 | $ 141,298 | |||
Promissory Notes [Member] | AFCO Credit Corporation [Member] | ||||||
Notes Payable [Abstract] | ||||||
Proceeds to pay insurance premiums | $ 469,042 | |||||
Down payments | $ 48,423 | |||||
Interest rate | 8.587% | |||||
Frequency of installment payments | monthly | |||||
Monthly principal and interest payments | $ 48,423 | |||||
Note payable | 283,334 | $ 283,334 | $ 141,298 | |||
Interest expense on loan | $ 7,998 | $ 5,352 | $ 9,317 | $ 7,235 |
Leases (Details)
Leases (Details) - USD ($) | 1 Months Ended | 9 Months Ended | |
Jul. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | |||
Operating lease payments | $ 3,321,025 | ||
Additional operating lease term | 63 months | ||
Lease extended date | Apr. 30, 2029 | ||
Right-of-use asset obtained in exchange for a lease liability | $ 2,496,968 | $ 2,496,968 | $ 0 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 9 Months Ended | |||
Apr. 20, 2023 | Apr. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Jul. 12, 2022 | |
Stockholders Equity [Abstract] | |||||
Common stock sold (in shares) | 1,318,000 | ||||
Gross proceeds from offering | $ 3,899,813 | $ 3,899,813 | |||
Placement agent fees expenses and offering expenses | $ 547,764 | ||||
Common stock, outstanding (in shares) | 15,992,869 | 11,869,704 | |||
Dividends declared or paid | $ 0 | ||||
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] | |||||
Authorized offering amount of securities | $ 8,800,000 | ||||
Common stock sold (in shares) | 1,318,000 | 2,869 | |||
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] - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | |
Number of Options [Roll Forward] | ||||
Beginning balance (in shares) | 1,019,671 | 886,495 | 931,550 | 931,550 |
Granted (in shares) | 1,064,800 | 153,200 | 5,000 | |
Forfeited (in shares) | (5,200) | (20,024) | (50,055) | |
Ending balance (in shares) | 2,079,271 | 1,019,671 | 886,495 | 2,079,271 |
Weighted Average Exercise Price [Abstract] | ||||
Beginning balance (in dollars per share) | $ 3.57 | $ 4.07 | $ 3.97 | $ 3.97 |
Granted (in dollars per share) | 0.49 | 0.75 | 1.18 | |
Forfeited (in dollars per share) | 1.25 | 3.94 | 1.87 | |
Ending balance (in dollars per share) | $ 2 | $ 3.57 | $ 4.07 | $ 2 |
Options vested and exercisable [Abstract] | ||||
Options vested and exercisable, Number of option vested (in shares) | 1,217,298 | 1,217,298 | ||
Options vested and exercisable, Exercise price (in dollars per share) | $ 2.62 | $ 2.62 | ||
Estimated Fair Value Assumptions [Abstract] | ||||
Options exercised (in shares) | 0 | |||
Common stock reserved for issuance (in shares) | 652,314 | 652,314 | ||
Employees [Member] | ||||
Number of Options [Roll Forward] | ||||
Granted (in shares) | 1,150,000 | |||
Weighted Average Exercise Price [Abstract] | ||||
Granted (in dollars per share) | $ 0.52 | |||
Options vested and exercisable [Abstract] | ||||
Weighted-average fair values of options granted (in dollars per share) | $ 0.42 | |||
Estimated Fair Value Assumptions [Abstract] | ||||
Expected term (in years) | 5 years 7 months 6 days | |||
Risk free interest rate | 4.06% | |||
Dividend yield | 0% | |||
Expected volatility | 105.14% | |||
Nonemployee [Member] | ||||
Number of Options [Roll Forward] | ||||
Granted (in shares) | 73,000 | |||
Weighted Average Exercise Price [Abstract] | ||||
Granted (in dollars per share) | $ 0.64 | |||
Options vested and exercisable [Abstract] | ||||
Weighted-average fair values of options granted (in dollars per share) | $ 0.51 | |||
Estimated Fair Value Assumptions [Abstract] | ||||
Expected term (in years) | 5 years 5 months 26 days | |||
Risk free interest rate | 3.96% | |||
Dividend yield | 0% | |||
Expected volatility | 106.58% |
Equity Incentive Plans and Wa_4
Equity Incentive Plans and Warrants, Inducement Grant (Details) - Inducement Grant [Member] | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Inducement Grant [Abstract] | |
Granted (in shares) | 0 |
Shares outstanding (in shares) | 150,000 |
Weighted average exercise price (in dollars per share) | $ / shares | $ 2.42 |
Options vested and exercisable, Number of option vested (in shares) | 25,000 |
Options vested and exercisable, Weighted average exercise price (in dollars per shares) | $ / shares | $ 2.97 |
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, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Expense [Abstract] | ||||
Share-based compensation expense | $ 504,359 | $ 51,762 | $ 626,529 | $ 158,288 |
Share-based compensation expense expected to be recognized for employees and nonemployees | 864,904 | 864,904 | ||
Compensation expense to be recognized upon achieving certain performance condition | 155,222 | |||
Unrecognized expenses | 709,682 | $ 709,682 | ||
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 | 79,561 | 10,820 | $ 131,812 | 73,395 |
Sales and Marketing [Member] | ||||
Share-based Compensation Expense [Abstract] | ||||
Share-based compensation expense | 623 | 1,515 | (1,319) | 3,857 |
General and Administrative [Member] | ||||
Share-based Compensation Expense [Abstract] | ||||
Share-based compensation expense | $ 424,175 | $ 39,427 | $ 496,036 | $ 81,036 |
Equity Incentive Plans and Wa_6
Equity Incentive Plans and Warrants, Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan [Member] | 9 Months Ended |
Sep. 30, 2023 shares | |
Employee Stock Purchase Plan [Abstract] | |
Stock issued (in shares) | 3,858 |
Common stock reserved for issuance (in shares) | 394,704 |
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 | Sep. 30, 2023 | Apr. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
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 | $ 547,764 | $ 0 | ||
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 | $ 1,059,975 | $ 1,059,975 | $ 0 | ||
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 | 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 | ||||
Warrants exercised (in shares) | 796,722 | ||||
Warrants outstanding (in shares) | 2,400,000 | 2,400,000 | |||
Placement Agent Warrants [Member] | |||||
Warrants [Abstract] | |||||
Warrants issued to purchase common stock (in shares) | 191,803 | ||||
Warrants term | 5 years | 5 years | |||
Warrants exercise price (In dollars per share) | $ 1.525 | ||||
Estimated Fair Value Assumptions [Abstract] | |||||
Warrants exercised (in shares) | 122,994 | ||||
Warrants outstanding (in shares) | 68,809 | 68,809 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||||
Net loss attributable to common stockholders, basic | $ (3,996,905) | $ (2,982,843) | $ (9,836,670) | $ (8,499,974) |
Net loss attributable to common stockholders, diluted | $ (3,996,905) | $ (2,982,843) | $ (9,836,670) | $ (8,499,974) |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic (in shares) | 15,093,147 | 11,813,610 | 13,369,462 | 11,810,289 |
Weighted average number of shares used in computing net loss per share attributable to common stockholders, diluted (in shares) | 15,093,147 | 11,813,610 | 13,369,462 | 11,810,289 |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.26) | $ (0.25) | $ (0.74) | $ (0.72) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.26) | $ (0.25) | $ (0.74) | $ (0.72) |
Weighted Average Number of Shares Outstanding [Abstract] | ||||
Options to purchase common stock (in shares) | 2,229,271 | 1,071,573 | 2,229,271 | 1,071,573 |
Warrants to purchase common stock, in connection with April 2023 financing (in shares) | 2,468,809 | 0 | 2,468,809 | 0 |
Warrants to purchase common stock (in shares) | 233,460 | 233,460 | 233,460 | 233,460 |
Total potential shares (in shares) | 4,931,540 | 1,305,033 | 4,931,540 | 1,305,033 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | 9 Months Ended | |||
Apr. 20, 2023 | Oct. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Issuance Sale of Common Stock [Abstract] | |||||
Cash proceeds from warrants exercised | $ 1,059,975 | $ 1,059,975 | $ 0 | ||
Gross cash proceeds from offering | $ 3,352,049 | ||||
Common Warrants [Member] | |||||
Issuance Sale of Common Stock [Abstract] | |||||
Warrants exercised (in shares) | 796,722 | ||||
Subsequent Event [Member] | At-the-Market Facility [Member] | |||||
Issuance Sale of Common Stock [Abstract] | |||||
Common stock authorized value to be issued by Sales Agent | $ 16,700,000 | ||||
Sale of common stock (in shares) | 3,256,754 | ||||
Gross cash proceeds from offering | $ 7,661,587 | ||||
Subsequent Event [Member] | Common Warrants [Member] | |||||
Issuance Sale of Common Stock [Abstract] | |||||
Warrants exercised (in shares) | 2,400,000 | ||||
Cash proceeds from warrants exercised | $ 2,628,000 |