Company gained CE Mark approval for four of its women’s health products and completed buildout of commercial team for its infertility portfolio
ATLANTA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the quarter ended June 30, 2024 and provides a corporate update.
Corporate Highlights from 2Q 2024 to date
- Company received European Union Medical Device Regulation (EU MDR) certification and CE Mark for four of its women’s health products, providing regulatory approval to begin marketing in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for its customers and their patients.
- Femasys completed the build-out of its initial commercial team in the U.S., which will be leading the Company’s marketing efforts. This milestone, together with the CE Mark approval for its product portfolio, enables Femasys to concurrently identify strategic distribution partners to begin commercialization of its products in the European Union.
- CEO and Founder Kathy Lee-Sepsick met with the White House’s Gender Policy Council to discuss the Company’s reproductive health products and the future of women’s health in the United States and the White House’s Office of Science and Technology Policy to discuss the Cancer Moonshot Initiative, as well as separately with Members of Congress to raise awareness of the Company and our women’s healthcare initiatives.
“The recruitment and subsequent onboarding of our commercial team, consisting of highly qualified professionals with specific expertise in women’s health is complete and our team has recently begun actively marketing our products in the U.S.. We believe that our novel fertility solution FemaSeed®, which demonstrated pregnancy rates more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility (i.e., low sperm count), is an improved alternative and a viable option prior to in vitro fertilization (IVF) that is considerably more financially and emotionally burdensome. As we await announcement of published data for the FemaSeed prospective multi-center pivotal trial, we are actively prioritizing our U.S. efforts and concurrently identifying strategic distribution partners in Europe,” said Femasys’ CEO Kathy Lee-Sepsick.
Financial Results for Quarter Ended June 30, 2024
- Research and development expenses increased by $448,703 to $1,975,875 in Q2 of 2024 from $1,527,172 in Q2 of 2023.
- Sales decreased by $99,030 to $221,484 in Q2 of 2024 from $320,514 in Q2 of 2023.
- Net loss was $4,684,574 or ($0.21) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2024, compared to net loss of $2,893,508, or ($0.22) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2023.
- Cash and cash equivalents as of June 30, 2024 was $13.5 million and the Company had an accumulated deficit of $116.7 million. The Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its ongoing operations into July 2025.
Financial Results for Six Months Ended June 30, 2024
- Research and development expenses increased by $681,995 to $3,746,606 for the first six months of 2024 from $3,064,611 for the first six months of 2023.
- Sales decreased by $121,874 to $492,624 for the first six months of 2024 from $614,498 for the first six months of 2023.
- Net loss was $8,284,084 or ($0.38) per basic and diluted share attributable to common stockholders, for the six month period ended June 30, 2024, compared to net loss of $5,839,765, or ($0.47) per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2023.
For more information, please refer to the Company’s Form 10-Q filed August 8, 2024, which can be accessed on the SEC website.
| FEMASYS INC. | |||||||||||||
| Condensed Balance Sheets | |||||||||||||
| (unaudited) | |||||||||||||
| Assets | June 30, 2024 | December 31, 2023 | |||||||||||
| Current assets: | |||||||||||||
| Cash and cash equivalents | $ | 13,525,898 | 21,716,077 | ||||||||||
| Accounts receivable, net | 92,535 | 98,906 | |||||||||||
| Inventory, net | 1,315,580 | 667,118 | |||||||||||
| Prepaid and other current assets | 997,623 | 695,879 | |||||||||||
| Total current assets | 15,931,636 | 23,177,980 | |||||||||||
| Property and equipment, at cost: | |||||||||||||
| Leasehold improvements | 1,212,417 | 1,212,417 | |||||||||||
| Office equipment | 47,308 | 47,308 | |||||||||||
| Furniture and fixtures | 429,933 | 414,303 | |||||||||||
| Machinery and equipment | 2,599,994 | 2,559,356 | |||||||||||
| Construction in progress | 651,157 | 423,077 | |||||||||||
| 4,940,809 | 4,656,461 | ||||||||||||
| Less accumulated depreciation | (3,678,450 | ) | (3,545,422 | ) | |||||||||
| Net property and equipment | 1,262,359 | 1,111,039 | |||||||||||
| Long-term assets: | |||||||||||||
| Lease right-of-use assets, net | 2,081,054 | 2,380,225 | |||||||||||
| Intangible assets, net of accumulated amortization | 44,317 | — | |||||||||||
| Other long-term assets | 957,078 | 1,086,581 | |||||||||||
| Total long-term assets | 3,082,449 | 3,466,806 | |||||||||||
| Total assets | $ | 20,276,444 | 27,755,825 | ||||||||||
| (continued) | |||||||||||||
| FEMASYS INC. | |||||||||||||
| Condensed Balance Sheets | |||||||||||||
| (unaudited) | |||||||||||||
| Liabilities and Stockholders’ Equity | June 30, 2024 | December 31, 2023 | |||||||||||
| Current liabilities: | |||||||||||||
| Accounts payable | $ | 951,510 | 1,137,823 | ||||||||||
| Accrued expenses | 886,352 | 1,444,296 | |||||||||||
| Clinical holdback – current portion | 92,397 | 65,300 | |||||||||||
| Lease liabilities – current portion | 533,734 | 406,636 | |||||||||||
| Total current liabilities | 2,463,993 | 3,054,055 | |||||||||||
| Long-term liabilities: | |||||||||||||
| Clinical holdback – long-term portion | 32,706 | 54,935 | |||||||||||
| Convertible notes payable, net (including related parties) | 4,758,017 | 4,258,179 | |||||||||||
| Lease liabilities – long-term portion | 1,771,487 | 2,036,067 | |||||||||||
| Total long-term liabilities | 6,562,210 | 6,349,181 | |||||||||||
| Total liabilities | 9,026,203 | 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 | |||||||||||||
| June 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 | 125,344,962 | 123,985,306 | |||||||||||
| Accumulated deficit | (116,665,713 | ) | (108,381,629 | ) | |||||||||
| Total stockholders’ equity | 11,250,241 | 18,352,589 | |||||||||||
| Total liabilities and stockholders’ equity | $ | 20,276,444 | 27,755,825 | ||||||||||
| FEMASYS INC. | |||||||||||||||||||
| Condensed Statements of Comprehensive Loss | |||||||||||||||||||
| (unaudited) | |||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||
| Sales | $ | 221,484 | 320,514 | 492,624 | 614,498 | ||||||||||||||
| Cost of sales (excluding depreciation expense) | 73,125 | 110,469 | 161,657 | 215,589 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 1,975,875 | 1,527,172 | 3,746,606 | 3,064,611 | |||||||||||||||
| Sales and marketing | 975,190 | 128,899 | 1,275,677 | 373,795 | |||||||||||||||
| General and administrative | 1,611,817 | 1,356,637 | 3,114,621 | 2,671,774 | |||||||||||||||
| Depreciation and amortization | 67,628 | 133,299 | 138,856 | 266,365 | |||||||||||||||
| Total operating expenses | 4,630,510 | 3,146,007 | 8,275,760 | 6,376,545 | |||||||||||||||
| Loss from operations | (4,482,151 | ) | (2,935,962 | ) | (7,944,793 | ) | (5,977,636 | ) | |||||||||||
| Other income (expense): | |||||||||||||||||||
| Interest income | 184,138 | 42,652 | 408,822 | 139,741 | |||||||||||||||
| Interest expense | (388,311 | ) | (198 | ) | (749,863 | ) | (1,870 | ) | |||||||||||
| Total other income (expense), net | (204,173 | ) | 42,454 | (341,041 | ) | 137,871 | |||||||||||||
| Loss before income taxes | (4,686,324 | ) | (2,893,508 | ) | (8,285,834 | ) | (5,839,765 | ) | |||||||||||
| Income tax benefit | (1,750 | ) | — | (1,750 | ) | — | |||||||||||||
| Net loss | $ | (4,684,574 | ) | (2,893,508 | ) | (8,284,084 | ) | (5,839,765 | ) | ||||||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (4,684,574 | ) | (2,893,508 | ) | (8,284,084 | ) | (5,839,765 | ) | ||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.21 | ) | (0.22 | ) | (0.38 | ) | (0.47 | ) | ||||||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 22,215,516 | 13,107,590 | 21,995,436 | 12,493,334 | |||||||||||||||
About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
Contacts:
Investors:
Gene Mannheimer
IR@femasys.com
Media Contact:
Kati Waldenburg
Media@femasys.com
