Full Press Release Details
Femasys Inc. Announces Financial Results for the Third Quarter of 2021
-- Up to 792-patient, pivotal LOCAL trial progressing for FemaSeed after receipt of investigational device exemption
(IDE) submission approval -
-- Femasys added to the Russell Microcap Index in Q3 --
ATLANTA, Nov. 10, 2021 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include
minimally invasive, in-office technologies for reproductive health, today announced financial results for the third quarter and nine months ended September 30, 2021 and provided a corporate update on the Company's business and clinical programs.
"Since becoming public approximately five months ago, we've gained substantial traction for our product candidates that have the opportunity to provide women access to
superior technologies and revolutionize their options related to reproductive care," stated Kathy Lee-Sepsick, president, chief executive officer and founder of Femasys. "Our pipeline progress has been driven by the advancement of FemaSeed, our
novel product candidate that delivers sperm directly to a selected fallopian tube where conception occurs, with enrollment progressing for our LOCAL trial that commenced in July, enrolling qualified women seeking conception at centers across the U.S.
with additional centers being added."
Ms. Lee-Sepsick, further commented, "We are now gearing up for the pivotal trial planned for next year associated with our planned IDE submission for FemBloc ,
our permanent birth control product candidate. We are eager to address the existing limitations of infertility and birth control options- both vast and underserved markets within women's reproductive health worldwide - with non-surgical solutions
that are driven by safety and affordability."
Recent Corporate Developments
Q3 Developments Related to Clinical Programs
Third Quarter (Three-Months) 2021 Financial Results:
Year to Date 2021 (Nine-Months) Financial Results:
Femasys Inc. is a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include minimally invasive, in-office
technologies for reproductive health. Its two lead product candidates are FemBloc permanent birth control and FemaSeed localized directional insemination for infertility. The Company's product for fallopian tube assessment
by ultrasound, FemVue , is currently marketed in the United States. Femasys is also advancing FemCerv , a technology platform for tissue sampling intended to be marketed alongside its other women-specific medical products in the
physician's office setting.
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," "intend," "believe," "potential" 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 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 product candidates; 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 11, 2021, 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.
LifeSci Advisors, LLC
LifeSci Communications
| Assets | September 30, 2021 | December 31, 2020 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 27,280,309 | 3,322,226 | |||||
| Accounts receivable, net | 143,459 | 125,790 | ||||||
| Inventory, net | 150,336 | 131,378 | ||||||
| Other current assets | 759,453 | 284,115 | ||||||
| Total current assets | 28,333,557 | 3,863,509 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,155,332 | 1,155,332 | ||||||
| Office equipment | 99,344 | 64,145 | ||||||
| Furniture and fixtures | 424,947 | 424,947 | ||||||
| Machinery and equipment | 2,262,908 | 2,242,088 | ||||||
| Construction in progress | 268,226 | 139,150 | ||||||
| 4,210,757 | 4,025,662 | |||||||
| Less accumulated depreciation | (2,600,787 | ) | (2,197,868 | ) | ||||
| Net property and equipment | 1,609,970 | 1,827,794 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 759,018 | 1,057,506 | ||||||
| Intangible assets, net of accumulated amortization | 33,046 | 65,069 | ||||||
| Other long-term assets | 428,933 | 792,440 | ||||||
| Total long-term assets | 1,220,997 | 1,915,015 | ||||||
| Total assets | $ | 31,164,524 | 7,606,318 |
| Liabilities, Redeemable Preferred Stock and Stockholders' Equity (Deficit) | September 30, 2021 | December 31, 2020 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 436,890 | 674,333 | |||||
| Accrued expenses | 597,856 | 1,117,601 | ||||||
| Clinical holdback - current portion | 18,947 | - | ||||||
| Notes payable - current portion | 320,866 | 630,010 | ||||||
| Lease liabilities - current portion | 412,911 | 434,072 | ||||||
| Other - current | 32,895 | 32,895 | ||||||
| Total current liabilities | 1,820,365 | 2,888,911 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 155,960 | 164,972 | ||||||
| Note payable - long-term portion | - | 182,490 | ||||||
| Lease liabilities - long-term portion | 501,912 | 809,092 | ||||||
| Other - long-term | 32,895 | 32,895 | ||||||
| Total long-term liabilities | 690,767 | 1,189,449 | ||||||
| Total liabilities | 2,511,132 | 4,078,360 | ||||||
| Commitments and contingencies | ||||||||
| Redeemable convertible preferred stock: | ||||||||
| Preferred stock, Series B, $.001 par, none authorized, issued and outstanding as of September 30, 2021; 13,344,349 shares authorized, issued and outstanding as of December 31, 2020 | - | 10,748,873 | ||||||
| Preferred stock, Series C, $.001 par, none authorized, issued and outstanding as of September 30, 2021; 42,491,484 shares authorized, issued and outstanding as of December 31, 2020 | - | 44,594,813 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock, $.001 par, 200,000,000 authorized, 11,916,943 shares issued and 11,799,720 outstanding as of September 30, 2021; and 95,583,558 authorized, 1,110,347 shares issued and 993,124 outstanding as of December 31, 2020 | 11,916 | 1,110 | ||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||
| Preferred stock, Series A, $.001 par, none authorized, issued and outstanding as of September 30, 2021; 17,310,609 shares authorized, and 17,210,609 shares issued and outstanding as of December 31, 2020 | - | 17,211 | ||||||
| Warrants | 702,492 | 702,492 | ||||||
| Additional paid-in-capital | 108,374,466 | 22,725,949 | ||||||
| Accumulated deficit | (80,375,482 | ) | (75,202,490 | ) | ||||
| Total stockholders' equity (deficit) | 28,653,392 | (51,815,728 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 31,164,524 | 7,606,318 |
Statements of Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Sales | $ | 269,581 | 313,208 | 925,362 | 756,954 | |||||||||||
| Cost of sales | 105,403 | 90,435 | 306,072 | 218,898 | ||||||||||||
| Gross margin | 164,178 | 222,773 | 619,290 | 538,056 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,140,577 | 995,620 | 3,030,467 | 3,235,022 | ||||||||||||
| Sales and marketing | 43,284 | 31,010 | 87,931 | 281,583 | ||||||||||||
| General and administrative | 1,087,363 | 596,778 | 3,030,749 | 1,790,595 | ||||||||||||
| Depreciation and amortization | 144,399 | 164,242 | 449,211 | 499,534 | ||||||||||||
| Total operating expenses | 2,415,623 | 1,787,650 | 6,598,358 | 5,806,734 | ||||||||||||
| Loss from operations | (2,251,445 | ) | (1,564,877 | ) | (5,979,068 | ) | (5,268,678 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 1,649 | 342 | 1,957 | 22,298 | ||||||||||||
| Other income | - | - | 821,515 | - | ||||||||||||
| Interest expense | (7,055 | ) | (3,760 | ) | (14,546 | ) | (9,093 | ) | ||||||||
| Other expense | (2,850 | ) | - | (2,850 | ) | - | ||||||||||
| Total other income (expense) | (8,256 | ) | (3,418 | ) | 806,076 | 13,205 | ||||||||||
| Loss before income taxes | (2,259,701 | ) | (1,568,295 | ) | (5,172,992 | ) | (5,255,473 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net loss | $ | (2,259,701 | ) | (1,568,295 | ) | (5,172,992 | ) | (5,255,473 | ) | |||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (2,259,701 | ) | (1,568,295 | ) | (5,172,992 | ) | (5,255,473 | ) | |||||||
| Change in fair value of available for sale investments | - | - | - | (20 | ) | |||||||||||
| Total comprehensive loss | $ | (2,259,701 | ) | (1,568,295 | ) | (5,172,992 | ) | (5,255,493 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (2,259,701 | ) | (1,568,295 | ) | (5,172,992 | ) | (5,255,473 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.19 | ) | (1.64 | ) | (1.04 | ) | (5.50 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 11,799,720 | 955,649 | 4,996,680 | 955,402 |