Full Press Release Details
Femasys Announces Financial Results for Quarter Ended March 31, 2024 and Provides Corporate Update
-- Recruitment of the commercial team for our infertility portfolio and the pivotal trial of FemBloc for permanent
non-surgical birth control continues --
ATLANTA, May 9, 2024 -- 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
"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
For more information, please refer to the Company's Form 10-Q filed May 9, 2024, which can be accessed on the SEC website.
Condensed Balance Sheets
| 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) |
Condensed Balance Sheets
| 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 |
Condensed Statements of Comprehensive Loss
| 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 |
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
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