Full Press Release Details
Femasys Inc. Announces Financial Results for the Third Quarter Ended
September 30, 2023 and Provides Corporate Update
- 510(k) product clearance gained for lead product, FemaSeed potentially allowing sooner-than-expected product commercialization
- Patient enrollment has commenced in landmark, pivotal FINALE trial for lead
product candidate, FemBloc , with academic sites enrolling trial participants -
- Raised $11.3 million extending cash runway due to the exercise of warrants and sale of shares under its at-the-market facility -
ATLANTA, November 14, 2023 -- Femasys Inc. (Nasdaq: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of
in-office, accessible solutions, including a leading late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate
"The past quarter was a watershed period for Femasys, gaining FDA clearance to market one of our two lead
programs, FemaSeed, via a 510(k) pre-market submission allowing for the accelerated commercialization of this important and innovative infertility treatment," said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys.
"Also, we have been rapidly initiating academic sites for participation in the landmark, pivotal FINALE trial of our leading, late-clinical stage product candidate, FemBloc, bringing us closer to making this
much needed non-surgical permanent birth control alternative available to women."
Third Quarter 2023 and Recent Corporate Highlights:
Third Quarter 2023 Financial Results
Year to Date 2023 (Nine-Month) Financial Results
| Assets | September 30, 2023 | December 31, 2022 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,692,435 | 12,961,936 | |||||
| Accounts receivable, net | 103,556 | 77,470 | ||||||
| Inventory, net | 602,668 | 436,723 | ||||||
| Other current assets | 826,373 | 655,362 | ||||||
| Total current assets | 10,225,032 | 14,131,491 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,195,637 | 1,195,637 | ||||||
| Office equipment | 99,344 | 99,344 | ||||||
| Furniture and fixtures | 419,303 | 419,303 | ||||||
| Machinery and equipment | 2,645,609 | 2,572,243 | ||||||
| Construction in progress | 394,957 | 413,843 | ||||||
| 4,754,850 | 4,700,370 | |||||||
| Less accumulated depreciation | (3,594,300 | ) | (3,217,319 | ) | ||||
| Net property and equipment | 1,160,550 | 1,483,051 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 2,530,571 | 319,557 | ||||||
| Intangible assets, net of accumulated amortization | 388 | 3,294 | ||||||
| Other long-term assets | 936,996 | 958,177 | ||||||
| Total long-term assets | 3,467,955 | 1,281,028 | ||||||
| Total assets | $ | 14,853,537 | 16,895,570 | |||||
| (continued) |
| Liabilities and Stockholders' Equity | September 30, 2023 | December 31, 2022 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 851,877 | 510,758 | |||||
| Accrued expenses | 569,442 | 456,714 | ||||||
| Note payable | 283,334 | 141,298 | ||||||
| Clinical holdback - current portion | 72,075 | 45,206 | ||||||
| Lease liabilities - current portion | 410,219 | 373,833 | ||||||
| Total current liabilities | 2,186,947 | 1,527,809 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 54,019 | 96,658 | ||||||
| Lease liabilities - long-term portion | 2,168,969 | 28,584 | ||||||
| Total long-term liabilities | 2,222,988 | 125,242 | ||||||
| Total liabilities | 4,409,935 | 1,653,051 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $.001 par, 200,000,000 authorized, 16,110,092 shares issued and 15,992,869 outstanding as of September 30, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022 | 16,110 | 11,987 | ||||||
| Treasury stock, 117,223 shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 1,581,608 | 567,972 | ||||||
| Additional paid-in-capital | 112,877,059 | 108,857,065 | ||||||
| Accumulated deficit | (103,971,175 | ) | (94,134,505 | ) | ||||
| Total stockholders' equity | 10,443,602 | 15,242,519 | ||||||
| Total liabilities and stockholders' equity | $ | 14,853,537 | 16,895,570 |
Statements of Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| $ | 244,361 | 347,456 | 858,859 | 971,974 | ||||||||||||
| Sales | 86,186 | 131,451 | 301,775 | 356,479 | ||||||||||||
| Cost of sales | 158,175 | 216,005 | 557,084 | 615,495 | ||||||||||||
| Gross margin | ||||||||||||||||
| Operating expenses: | 2,072,830 | 1,648,160 | 5,137,441 | 4,542,147 | ||||||||||||
| Research and development | 70,883 | 90,374 | 444,678 | 222,414 | ||||||||||||
| Sales and marketing | 1,970,408 | 1,395,063 | 4,642,182 | 4,024,356 | ||||||||||||
| General and administrative | 125,318 | 139,597 | 391,683 | 426,480 | ||||||||||||
| Depreciation and amortization | 4,239,439 | 3,273,194 | 10,615,984 | 9,215,397 | ||||||||||||
| Total operating expenses | (4,081,264 | ) | (3,057,189 | ) | (10,058,900 | ) | (8,599,902 | ) | ||||||||
| Loss from operations | ||||||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 92,392 | 80,373 | 232,133 | 109,572 | ||||||||||||
| Interest expense | (8,033 | ) | (6,005 | ) | (9,903 | ) | (9,622 | ) | ||||||||
| Other expense | - | (22 | ) | - | (22 | ) | ||||||||||
| Other income (expense), net | 84,359 | 74,346 | 222,230 | 99,928 | ||||||||||||
| Net loss | $ | (3,996,905 | ) | (2,982,843 | ) | (9,836,670 | ) | (8,499,974 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (3,996,905 | ) | (2,982,843 | ) | (9,836,670 | ) | (8,499,974 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.26 | ) | (0.25 | ) | (0.74 | ) | (0.72 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 15,093,147 | 11,813,610 | 13,369,462 | 11,810,289 |
FemaSeed is a first-of-its-kind infertility solution in development for directional intrauterine insemination that delivers sperm to the fallopian tube where
conception occurs. It is intended to augment natural fertilization and provide a first-line treatment option for infertility. FemaSeed is designed to be less invasive and more affordable than assisted reproduction, such as in vitro fertilization
(IVF) or intracytoplasmic sperm injection (ICSI). For more information, visit www.FemaSeed.com.
FemBloc is a first-of-its-kind, non-surgical, non-implant, in-office solution in late-stage clinical development for permanent birth control. It is
intended to be a safer option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer a
convenient, accessible, and reliable option to women seeking permanent birth control. For over 100 years, there has been stagnant innovation in the area of permanent birth control; this could lead to a $20 billion market expansion opportunity for
FemBloc in the U.S. alone. For more information, visit www.FemBloc.com.
FemVue is the first FDA-cleared product that creates natural saline and air contrast and enables safe, reliable, and real time evaluation of the fallopian tubes with
ultrasound. When performed with a uterine cavity assessment, a more comprehensive exam can be achieved from the comfort of the GYN's office. For more information, visit www.FemVue.com.
FemCath is the first FDA-cleared product that allows for selective evaluation of the fallopian tubes by using in conjunction with the FemVue device. The ultrasound-based
diagnostic test is part of an infertility evaluation, which is essential prior to any infertility treatment, including with our other biomedical solution in development, FemaSeed.
FemCerv is the first FDA-cleared product that allows for the capture and protection of a comprehensive
360-degree endocervical tissue sample in a relatively pain-free office visit. FemCerv features an expandable collection chamber that is exposed during sampling and closed during removal for containment of cervical cells and tissue for diagnosis
of cervical cancer. For more information, visit www.FemCerv.com.
Femasys Inc. is a biomedical company focused on meeting women's unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that
include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates in late-stage clinical development are FemBloc permanent birth control and FemaSeed localized directional
insemination for infertility. The Company has developed diagnostic products that complement these two lead product candidates for which it has achieved regulatory approvals to market in the U.S., Canada and other countries outside the U.S and are
commercial ready with in-house manufacturing capabilities. The Company's diagnostic products include FemVue for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath , an intrauterine catheter
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 ability to commercialize our product candidates, or the effect of delays in commercializing; 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, 2022 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
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