Full Press Release Details
Femasys Inc. Announces Financial Results for the Second Quarter of 2021
Completed initial public offering ("IPO") raising net proceeds of $31.6 million
Appointed Anne Morrissey to the Board of Directors, an industry expert with decades of medical device experience
Initiated 792-patient, pivotal LOCAL trial after receipt of investigational device exemption (IDE) submission approval for FemaSeed
Atlanta, GA. --- August 11, 2021 --- Femasys Inc. (NASDAQ: FEMY), a biomedical company developing a suite of product candidates to transform women's healthcare with minimally invasive, non-surgical, in-office technologies, today announced
financial results for the second quarter and six months ended June 30, 2021.
"This is an exciting time of growth for Femasys after becoming a publicly traded company on June 18th," stated Kathy Lee-Sepsick, president, chief executive officer and founder of Femasys. "We are galvanizing on all fronts to advance
FemaSeed , our localized directional insemination product candidate that is part of our fertility portfolio, through clinical development and are thrilled to have treated the first patient in our prospective, multi-center
pivotal LOCAL trial in July."
Ms. Lee-Sepsick, further commented, "We are continuing our clinical work with FemBloc , our permanent birth control product candidate, in preparation for an IDE submission for a pivotal trial planned for next year. Both reproductive
products may provide women access to superior technologies and increase their options related to reproductive care. We remain enthusiastic and poised to address the vast underserved markets within women's health worldwide with our next-generation
Recent Corporate Developments
Recent Developments Related to Clinical Programs
Second Quarter (Three-Months) 2021 Financial Results:
Year to Date 2021 (Six-Months) Financial Results:
Femasys is a biomedical company developing a suite of product candidates to transform women's healthcare with minimally invasive, non-surgical, in-office technologies. Its two lead reproductive health product candidates include 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 our 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 | June 30, 2021 | December 31, 2020 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 29,858,868 | 3,322,226 | |||||
| Accounts receivable, net | 158,837 | 125,790 | ||||||
| Inventory, net | 146,879 | 131,378 | ||||||
| Other current assets | 868,842 | 284,115 | ||||||
| Total current assets | 31,033,426 | 3,863,509 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,155,332 | 1,155,332 | ||||||
| Office equipment | 64,145 | 64,145 | ||||||
| Furniture and fixtures | 424,947 | 424,947 | ||||||
| Machinery and equipment | 2,242,088 | 2,242,088 | ||||||
| Construction in progress | 151,662 | 139,150 | ||||||
| 4,038,174 | 4,025,662 | |||||||
| Less accumulated depreciation | (2,470,397 | ) | (2,197,868 | ) | ||||
| Net property and equipment | 1,567,777 | 1,827,794 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 854,817 | 1,057,506 | ||||||
| Intangible assets, net of accumulated amortization | 42,185 | 65,069 | ||||||
| Other long-term assets | 488,961 | 792,440 | ||||||
| Total long-term assets | 1,385,963 | 1,915,015 | ||||||
| Total assets | $ | 33,987,166 | 7,606,318 |
| Liabilities, Redeemable Preferred Stock and Stockholders' Equity (Deficit) | June 30, 2021 | December 31, 2020 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 947,078 | 674,333 | |||||
| Accrued expenses | 430,183 | 1,117,601 | ||||||
| Clinical holdback - current portion | 18,947 | - | ||||||
| Notes payable - current portion | 470,556 | 630,010 | ||||||
| Lease liabilities - current portion | 419,333 | 434,072 | ||||||
| Other - current | 32,895 | 32,895 | ||||||
| Total current liabilities | 2,318,992 | 2,888,911 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 151,958 | 164,972 | ||||||
| Note payable - long-term portion | - | 182,490 | ||||||
| Lease liabilities - long-term portion | 603,616 | 809,092 | ||||||
| Other - long-term | 32,895 | 32,895 | ||||||
| Total long-term liabilities | 788,469 | 1,189,449 | ||||||
| Total liabilities | 3,107,461 | 4,078,360 | ||||||
| Commitments and contingencies | ||||||||
| Redeemable convertible preferred stock: | ||||||||
| Preferred stock, Series B, $.001 par, none authorized, issued and outstanding as of June 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 June 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 June 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 June 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 | 108,341,078 | 22,725,949 | ||||||
| Accumulated deficit | (78,115,781 | ) | (75,202,490 | ) | ||||
| Total stockholders' equity (deficit) | 30,879,705 | (51,815,728 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 33,987,166 | 7,606,318 |
Statements of Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Sales | $ | 326,006 | 183,234 | 655,781 | 443,746 | |||||||||||
| Cost of sales | 107,627 | 55,275 | 200,669 | 128,463 | ||||||||||||
| Gross margin | 218,379 | 127,959 | 455,112 | 315,283 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 894,868 | 888,701 | 1,889,890 | 2,239,402 | ||||||||||||
| Sales and marketing | 21,828 | 13,384 | 44,647 | 250,573 | ||||||||||||
| General and administrative | 1,051,399 | 543,625 | 1,943,386 | 1,193,817 | ||||||||||||
| Depreciation and amortization | 151,359 | 165,882 | 304,812 | 335,292 | ||||||||||||
| Total operating expenses | 2,119,454 | 1,611,592 | 4,182,735 | 4,019,084 | ||||||||||||
| Loss from operations | (1,901,075 | ) | (1,483,633 | ) | (3,727,623 | ) | (3,703,801 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 144 | 1,620 | 308 | 21,956 | ||||||||||||
| Other income | 821,515 | - | 821,515 | - | ||||||||||||
| Interest expense | (3,643 | ) | (3,438 | ) | (7,491 | ) | (5,333 | ) | ||||||||
| Total other income (expense) | 818,016 | (1,818 | ) | 814,332 | 16,623 | |||||||||||
| Loss before income taxes | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net loss | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | |||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | |||||||
| Change in fair value of available for sale investments | - | - | - | (20 | ) | |||||||||||
| Total comprehensive loss | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,198 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (1,083,059 | ) | (1,485,451 | ) | (2,913,291 | ) | (3,687,178 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.52 | ) | (1.55 | ) | (1.89 | ) | (3.86 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 2,076,516 | 955,279 | 1,538,780 | 955,279 |