Full Press Release Details
Femasys Inc. Announces Financial Results for the Third Quarter Ended
September 30, 2022 and Provides Corporate Update
--FemaSeed de novo trial enrollment accelerates with strategic trial design update to focus on male factor
--Company remains on track to file an Investigational Device
Exemption (IDE) for a pivotal trial to support a Pre-Market Authorization (PMA) for FemBloc in Q1 2023--
--FemCerv now commercially available with FemCath launch expected by year-end--
ATLANTA, November 10, 2022 -- 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, 2022 and provided a corporate update.
"We've hit multiple company milestones this past quarter, as well as further strengthened our management team in key functional areas," said Kathy Lee-Sepsick, founder,
president and chief executive officer of Femasys. "Most notably, we completed enrollment in our Stage 2 trial of FemBloc permanent birth control and strategically updated the FemaSeed de novo trial design, accelerating
enrollment for this important program. Approximately 50% of infertility is attributed to male factor and FemaSeed is being studied to offer a cost-effective, efficacious option to existing invasive and expensive treatment alternatives. We also made
FemCerv , designed for comprehensive cervical sampling and minimal contamination for the diagnosis of cervical cancer, available to gynecologists. To support all of these high-value programs, we have sales and marketing as well as
regulatory and clinical affairs teams well-positioned to lead us towards the next catalysts for the company at this pivotal time."
Third Quarter and Recent Developments Related to Clinical Programs and Commercial Products
Third Quarter and Recent Corporate Highlights
Third Quarter 2022 Financial Results
Year to Date 2022 (Nine-Months) Financial Results
Net loss was $8,499,974, or $0.72 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the nine months ended September 30, 2022,
compared to $5,172,992, or $1.04 per basic and diluted share attributable to common stockholders, for the nine months ended September 30, 2021.
| Assets | September 30, 2022 | December 31, 2021 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,005,650 | 24,783,029 | |||||
| Accounts receivable, net | 183,130 | 84,258 | ||||||
| Inventory, net | 343,136 | 208,270 | ||||||
| Other current assets | 760,573 | 555,853 | ||||||
| Total current assets | 17,292,489 | 25,631,410 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,195,637 | 1,155,332 | ||||||
| Office equipment | 99,344 | 99,344 | ||||||
| Furniture and fixtures | 424,947 | 424,947 | ||||||
| Machinery and equipment | 2,434,524 | 2,261,793 | ||||||
| Construction in progress | 503,312 | 379,713 | ||||||
| 4,657,764 | 4,321,129 | |||||||
| Less accumulated depreciation | (3,115,551 | ) | (2,722,117 | ) | ||||
| Net property and equipment | 1,542,213 | 1,599,012 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 402,063 | 665,747 | ||||||
| Intangible assets, net of accumulated amortization | 5,759 | 25,093 | ||||||
| Other long-term assets | 789,616 | 655,418 | ||||||
| Total long-term assets | 1,197,438 | 1,346,258 | ||||||
| Total assets | $ | 20,032,140 | 28,576,680 |
| Liabilities and Stockholders' Equity | September 30, 2022 | December 31, 2021 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 419,110 | 445,522 | |||||
| Accrued expenses | 649,615 | 603,787 | ||||||
| Clinical holdback - current portion | 36,238 | 18,947 | ||||||
| Note payable | 280,577 | 181,123 | ||||||
| Lease liabilities - current portion | 386,139 | 406,674 | ||||||
| Other | 36,037 | 36,037 | ||||||
| Total current liabilities | 1,807,716 | 1,692,090 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 101,804 | 149,791 | ||||||
| Lease liabilities - long-term portion | 115,773 | 402,417 | ||||||
| Total long-term liabilities | 217,577 | 552,208 | ||||||
| Total liabilities | 2,025,293 | 2,244,298 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par, 200,000,000 authorized, 11,930,833 shares issued and 11,813,610 outstanding as of September 30, 2022; and 11,921,388 shares issued 11,804,165 outstanding as of December 31, 2021 | 11,931 | 11,921 | ||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 567,972 | 702,492 | ||||||
| Additional paid-in-capital | 108,727,253 | 108,418,304 | ||||||
| Accumulated deficit | (91,240,309 | ) | (82,740,335 | ) | ||||
| Total stockholders' equity | 18,006,847 | 26,332,382 | ||||||
| Total liabilities and stockholders' equity | $ | 20,032,140 | 28,576,680 |
Statements of Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Sales | $ | 347,456 | 269,581 | 971,974 | 925,362 | |||||||||||
| Cost of sales | 131,451 | 105,403 | 356,479 | 306,072 | ||||||||||||
| Gross margin | 216,005 | 164,178 | 615,495 | 619,290 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,648,160 | 1,140,577 | 4,542,147 | 3,030,467 | ||||||||||||
| Sales and marketing | 90,374 | 43,284 | 222,414 | 87,931 | ||||||||||||
| General and administrative | 1,395,063 | 1,087,363 | 4,024,356 | 3,030,749 | ||||||||||||
| Depreciation and amortization | 139,597 | 144,399 | 426,480 | 449,211 | ||||||||||||
| Total operating expenses | 3,273,194 | 2,415,623 | 9,215,397 | 6,598,358 | ||||||||||||
| Loss from operations | (3,057,189 | ) | (2,251,445 | ) | (8,599,902 | ) | (5,979,068 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 80,373 | 1,649 | 109,572 | 1,957 | ||||||||||||
| Other income | - | - | - | 821,515 | ||||||||||||
| Interest expense | (6,005 | ) | (7,055 | ) | (9,622 | ) | (14,546 | ) | ||||||||
| Other expense | (22 | ) | (2,850 | ) | (22 | ) | (2,850 | ) | ||||||||
| Other income (expense), net | 74,346 | (8,256 | ) | 99,928 | 806,076 | |||||||||||
| Net loss | $ | (2,982,843 | ) | (2,259,701 | ) | (8,499,974 | ) | (5,172,992 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (2,982,843 | ) | (2,259,701 | ) | (8,499,974 | ) | (5,172,992 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.25 | ) | (0.19 | ) | (0.72 | ) | (1.04 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 11,813,610 | 11,799,720 | 11,810,289 | 4,996,680 |
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 FemCath , an intrauterine catheter for selective evaluation of the fallopian tubes and FemCerv , an endocervical tissue sampler that is the first product of the technology platform for tissue sampling intended to be marketed alongside its other women-specific medical products in the physician's office
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 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 Annual Report on Form 10-K for the year ended December 31, 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
Karissa Cross, Ph.D.
LifeSci Communications