Corporate Highlights from 4Q 2023 to date
- Company announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility
- Following FDA clearance of FemaSeed, the Company’s revolutionary approach to artificial insemination,
Femasys announced completion of enrollment in pivotal trial in support of commercial launch - Activated enrollment for remaining clinical sites of initial phase of pivotal trial for FemBloc®, the Company’s proprietary solution for permanent non-surgical birth control
- Appointed
Richard Spector as Chief Commercial Officer andJames Liu , M.D. as Chief Medical Officer
“The end of 2023 marked a significant milestone for the Company as we achieved the FDA clearance of FemaSeed, enabling it to become a first-line accessible and cost-effective therapeutic option for couples and women experiencing infertility. We also announced positive topline data for the product’s pivotal trial earlier this month, revealing that 24% of women in the severe male factor cohort became pregnant after receiving FemaSeed. Notably, the majority of women who became pregnant did so after the first FemaSeed procedure,” said Femasys’ CEO
Financial Results for Year Ended
- Research and Development expenses increased by
$1,394,946 to$7,208,701 in 2023 from$5,813,755 in 2022 - Sales decreased by
$134,248 to$1,071,970 in 2023 from$1,206,218 in 2022 - Net loss was
$14,247,124 or$0.93 per basic and diluted share attributable to common stockholders, for the year endedDecember 31, 2023 , compared to net loss of$11,394,170 , or$0.96 per basic and diluted share attributable to common stockholders, for the year endedDecember 31, 2022 - Cash and cash equivalents as of
December 31, 2023 was$21,716,077 and the Company had an accumulated deficit of$108,381,629 . 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-K filed
Balance Sheets | |||||||||||||
(unaudited) | |||||||||||||
Assets | |||||||||||||
Current assets: | |||||||||||||
Cash and cash equivalents | $ | 21,716,077 | 12,961,936 | ||||||||||
Accounts receivable, net | 98,906 | 77,470 | |||||||||||
Inventory, net | 667,118 | 436,723 | |||||||||||
Prepaid and other current assets | 695,879 | 655,362 | |||||||||||
Total current assets | 23,177,980 | 14,131,491 | |||||||||||
Property and equipment, at cost: | |||||||||||||
Leasehold improvements | 1,212,417 | 1,195,637 | |||||||||||
Office equipment | 47,308 | 99,344 | |||||||||||
Furniture and fixtures | 414,303 | 419,303 | |||||||||||
Machinery and equipment | 2,559,356 | 2,572,243 | |||||||||||
Construction in progress | 423,077 | 413,843 | |||||||||||
4,656,461 | 4,700,370 | ||||||||||||
Less accumulated depreciation | (3,545,422 | ) | (3,217,319 | ) | |||||||||
Net property and equipment | 1,111,039 | 1,483,051 | |||||||||||
Long-term assets: | |||||||||||||
Lease right-of-use assets, net | 2,380,225 | 319,557 | |||||||||||
Intangible assets, net of accumulated amortization | — | 3,294 | |||||||||||
Other long-term assets | 1,086,581 | 958,177 | |||||||||||
Total long-term assets | 3,466,806 | 1,281,028 | |||||||||||
Total assets | $ | 27,755,825 | 16,895,570 | ||||||||||
(continued) | |||||||||||||
Balance Sheets | |||||||||||||
(unaudited) | |||||||||||||
Liabilities and Stockholders’ Equity | |||||||||||||
Current liabilities: | |||||||||||||
Accounts payable | $ | 1,137,823 | 510,758 | ||||||||||
Accrued expenses | 1,444,296 | 456,714 | |||||||||||
Note payable | — | 141,298 | |||||||||||
Clinical holdback – current portion | 65,300 | 45,206 | |||||||||||
Lease liabilities – current portion | 406,636 | 373,833 | |||||||||||
Total current liabilities | 3,054,055 | 1,527,809 | |||||||||||
Long-term liabilities: | |||||||||||||
Clinical holdback – long-term portion | 54,935 | 96,658 | |||||||||||
Convertible notes payable, net (including related parties) | 4,258,179 | — | |||||||||||
Lease liabilities – long-term portion | 2,036,067 | 28,584 | |||||||||||
Total long-term liabilities | 6,349,181 | 125,242 | |||||||||||
Total liabilities | 9,403,236 | 1,653,051 | |||||||||||
Commitments and contingencies | |||||||||||||
Stockholders’ equity: | |||||||||||||
Common stock, | |||||||||||||
21,774,604 shares issued and 21,657,381 outstanding as of | |||||||||||||
and 11,869,704 outstanding as of | 21,775 | 11,987 | |||||||||||
(60,000 | ) | (60,000 | ) | ||||||||||
Warrants | 2,787,137 | 567,972 | |||||||||||
Additional paid-in-capital | 123,985,306 | 108,857,065 | |||||||||||
Accumulated deficit | (108,381,629 | ) | (94,134,505 | ) | |||||||||
Total stockholders’ equity | 18,352,589 | 15,242,519 | |||||||||||
Total liabilities and stockholders' equity | $ | 27,755,825 | 16,895,570 | ||||||||||
Statements of Comprehensive Loss | |||||||||||||
(unaudited) | |||||||||||||
Sales | $ | 1,071,970 | 1,206,218 | ||||||||||
Cost of sales (excluding depreciation expense) | 380,069 | 441,938 | |||||||||||
Operating expenses: | |||||||||||||
Research and development | 7,208,701 | 5,813,755 | |||||||||||
Sales and marketing | 650,126 | 558,852 | |||||||||||
General and administrative | 6,858,008 | 5,430,704 | |||||||||||
Depreciation and amortization | 483,481 | 561,233 | |||||||||||
Total operating expenses | 15,200,316 | 12,364,544 | |||||||||||
Loss from operations | (14,508,415 | ) | (11,600,264 | ) | |||||||||
Other income (expense): | |||||||||||||
Interest income | 431,019 | 228,164 | |||||||||||
Interest expense | (165,390 | ) | (13,464 | ) | |||||||||
Other expense | — | (2,306 | ) | ||||||||||
Total other income | 265,629 | 212,394 | |||||||||||
Loss before income taxes | (14,242,786 | ) | (11,387,870 | ) | |||||||||
Income tax expense | 4,338 | 6,300 | |||||||||||
Net loss | $ | (14,247,124 | ) | (11,394,170 | ) | ||||||||
Net loss attributable to common stockholders, basic and diluted | $ | (14,247,124 | ) | (11,394,170 | ) | ||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.93 | ) | (0.96 | ) | ||||||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 15,384,376 | 11,815,019 | |||||||||||
About
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,” “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
Contacts:
Investors:
IR@femasys.com
Media Contact:
Media@femasys.com
Source:
2024 GlobeNewswire, Inc., source