-- Recruitment of the commercial team for our infertility portfolio and the pivotal trial of FemBloc® for permanent non-surgical birth control continues --
ATLANTA, May 09, 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 March 31, 2024 and provides a corporate update.
Corporate Highlights from 1Q 2024 to date
- Company announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility.
- Company announced the first in-office commercial procedure with FDA-cleared FemaSeed infertility solution at a former investigative site.
- Appointed Richard Spector as Chief Commercial Officer.
- Initiated enrollment in pivotal trial (NCT05977751) of our permanent birth control candidate FemBloc at two academic sites, for a total of six active sites, the maximum permitted in the first stage.
“Femasys is well positioned to commercialize our infertility portfolio, led by FemaSeed in 2024 with promising top line data from the FemaSeed pivotal trial that was more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility (i.e., low sperm count). We are focused on completing recruitment of the commercial team and ramping up commercial operations, while continuing to support enrollment in our pivotal trial for FemBloc, our proprietary solution for permanent non-surgical birth control,” said Femasys’ CEO Kathy Lee-Sepsick. “We believe we have sufficient cash to fund operations into the second half of 2025, allowing us to continue our track record of achieving our stated milestones and moving our mission forward to deliver innovative purposely engineered solutions for women’s health that are safe, effective, accessible, and affordable.”
Financial Results for Quarter Ended March 31, 2024
- Research and development expenses increased by $233,292 to $1,770,731 in Q1 of 2024 from $1,537,439 in Q1 of 2023
- Sales decreased by $22,844 to $271,140 in Q1 of 2024 from $293,984 in Q1 of 2023
- Net loss was $3,599,510 or $0.17 per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2024, compared to net loss of $2,946,257, or $0.25 per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2023
- Cash and cash equivalents as of March 31, 2024 was $17,835,968 and the Company had an accumulated deficit of $111,981,139. 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 the second half of 2025
For more information, please refer to the Company’s Form 10-Q filed May 9, 2024, which can be accessed on the SEC website.
| FEMASYS INC. | ||||||||||||
| Condensed Balance Sheets | ||||||||||||
| (unaudited) | ||||||||||||
| Assets | March 31, 2024 | December 31, 2023 | ||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 17,835,968 | 21,716,077 | |||||||||
| Accounts receivable, net | 120,529 | 98,906 | ||||||||||
| Inventory, net | 971,297 | 667,118 | ||||||||||
| Prepaid and other current assets | 955,539 | 695,879 | ||||||||||
| Total current assets | 19,883,333 | 23,177,980 | ||||||||||
| Property and equipment, at cost: | ||||||||||||
| Leasehold improvements | 1,212,417 | 1,212,417 | ||||||||||
| Office equipment | 47,308 | 47,308 | ||||||||||
| Furniture and fixtures | 417,654 | 414,303 | ||||||||||
| Machinery and equipment | 2,582,220 | 2,559,356 | ||||||||||
| Construction in progress | 569,723 | 423,077 | ||||||||||
| 4,829,322 | 4,656,461 | |||||||||||
| Less accumulated depreciation | (3,615,405 | ) | (3,545,422 | ) | ||||||||
| Net property and equipment | 1,213,917 | 1,111,039 | ||||||||||
| Long-term assets: | ||||||||||||
| Lease right-of-use assets, net | 2,227,561 | 2,380,225 | ||||||||||
| Intangible assets, net of accumulated amortization | 33,115 | — | ||||||||||
| Other long-term assets | 1,013,034 | 1,086,581 | ||||||||||
| Total long-term assets | 3,273,710 | 3,466,806 | ||||||||||
| Total assets | $ | 24,370,960 | 27,755,825 | |||||||||
| (continued) | ||||||||||||
| FEMASYS INC. | ||||||||||||
| Condensed Balance Sheets | ||||||||||||
| (unaudited) | ||||||||||||
| Liabilities and Stockholders’ Equity | March 31, 2024 | December 31, 2023 | ||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 1,095,730 | 1,137,823 | |||||||||
| Accrued expenses | 673,457 | 1,444,296 | ||||||||||
| Clinical holdback – current portion | 93,376 | 65,300 | ||||||||||
| Lease liabilities – current portion | 494,967 | 406,636 | ||||||||||
| Total current liabilities | 2,357,530 | 3,054,055 | ||||||||||
| Long-term liabilities: | ||||||||||||
| Clinical holdback – long-term portion | 30,389 | 54,935 | ||||||||||
| Convertible notes payable, net (including related parties) | 4,472,456 | 4,258,179 | ||||||||||
| Lease liabilities – long-term portion | 1,902,991 | 2,036,067 | ||||||||||
| Total long-term liabilities | 6,405,836 | 6,349,181 | ||||||||||
| Total liabilities | 8,763,366 | 9,403,236 | ||||||||||
| Commitments and contingencies | ||||||||||||
| Stockholders’ equity: | ||||||||||||
| Common stock, $.001 par, 200,000,000 authorized, | ||||||||||||
| 22,216,570 shares issued and 22,099,347 outstanding as of | ||||||||||||
| March 31, 2024; and 21,774,604 shares issued | ||||||||||||
| and 21,657,381 outstanding as of December 31, 2023 | 22,217 | 21,775 | ||||||||||
| Treasury stock, 117,223 common shares | (60,000 | ) | (60,000 | ) | ||||||||
| Warrants | 2,631,838 | 2,787,137 | ||||||||||
| Additional paid-in-capital | 124,994,678 | 123,985,306 | ||||||||||
| Accumulated deficit | (111,981,139 | ) | (108,381,629 | ) | ||||||||
| Total stockholders’ equity | 15,607,594 | 18,352,589 | ||||||||||
| Total liabilities and stockholders' equity | $ | 24,370,960 | 27,755,825 | |||||||||
| FEMASYS INC. | |||||||||||
| Condensed Statements of Comprehensive Loss | |||||||||||
| (unaudited) | |||||||||||
| Three Months Ended March 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Sales | $ | 271,140 | 293,984 | ||||||||
| Cost of sales (excluding depreciation expense) | 88,532 | 105,120 | |||||||||
| Operating expenses: | |||||||||||
| Research and development | 1,770,731 | 1,537,439 | |||||||||
| Sales and marketing | 300,487 | 244,896 | |||||||||
| General and administrative | 1,502,804 | 1,315,137 | |||||||||
| Depreciation and amortization | 71,228 | 133,066 | |||||||||
| Total operating expenses | 3,645,250 | 3,230,538 | |||||||||
| Loss from operations | (3,462,642 | ) | (3,041,674 | ) | |||||||
| Other income (expense): | |||||||||||
| Interest income | 224,684 | 97,089 | |||||||||
| Interest expense | (361,552 | ) | (1,672 | ) | |||||||
| Total other income (expense) | (136,868 | ) | 95,417 | ||||||||
| Net loss | $ | (3,599,510 | ) | (2,946,257 | ) | ||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (3,599,510 | ) | (2,946,257 | ) | ||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.17 | ) | (0.25 | ) | ||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 21,775,357 | 11,872,255 | |||||||||
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. 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, 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
