IPO Launch on the NASDAQ; $31.6 Million Dollar Raise; Clinical Trials Underway on Key Female Oriented Healthcare Advances: Femasys (NASDAQ: FEMY)
– Commitment and Company Focus on Transforming Women’s Healthcare.
– $34.45 Million IPO Completed to Fund Operations and Clinical Trials.
– IPO Process Managed by Experienced Global Investment Bank Chardan.
– Developing Novel Solutions and Next Generation Medical Advances.
– Significant Clinical Impact to Address Severely Underserved Areas.
Femasys, Inc. (NASDAQ: FEMY) is a woman-led company under the direction of Kathy Lee-Sepsick, President, CEO and Founder. FEMY has developed a suite of products and product candidates that address several large global market segments in which there has been little advancement for many years. FEMY has an expansive, internally created intellectual property portfolio with over 100 patents globally. With proven ability to develop and commercialize products, FEMY is positioning to become a leading company in the women’s healthcare space with solutions to address multi-billion dollar global opportunities.
FEMY will use the proceeds of its recent $34.45 Million IPO to fund the completion of enrollment in the stage 2 clinical trial and commencement of the stage 3 clinical trial for the company’s Permanent Birth Control FemBloc system and for the initiation and completion of the pivotal trial for its Fertility FemaSeed system. FEMY also has other fertility products in development for Occlusion Confirmation, Localized Directional Insemination, Infertility Diagnosis and Endocervical Tissue Sampler Biopsy. The FEMY IPO proceeds will further be used to fund product development and research and development activities, to hire additional personnel, and for working capital and general corporate purposes.
— Recent Developments Related to Clinical Programs
On April 8, 2021, Femasys received IDE approval to begin a multi-center, pivotal clinical trial (the “LOCAL trial”) of FEMASEED, a first-in-class, localized directional insemination product candidate for infertility.
On July 20, 2021, Femasys announced the initiation and first patient treated in the LOCAL trial. The trial is being conducted across approximately 20 centers in the United States and is expected to enroll up to 792 patients diagnosed as infertile. The primary endpoints of the study are to determine the effectiveness (clinical pregnancy rate) and safety over a period of 7 weeks. Enrollment in this trial is ongoing.
On June 17, 2021, Femasys announced the pricing of its initial public offering of 2,650,000 shares of its common stock at a public price of $13.00 per share. The net proceeds to Femasys from the offering, after deducting the underwriting discounts and commissions and legal expenses, totaled $31,613,500. Shares began trading on the Nasdaq Capital Market on June 18, 2021, under the ticker symbol “FEMY”. The offering closed on June 22, 2021.
On June 24, 2021, Femasys announced the appointment of Anne Morrissey to the company’s board of directors. Ms. Morrissey brings decades of experience to Femasys. Most recently, Anne served as President and Chief Executive Officer of Alydia Health from 2016 to 2020, and thereafter as an advisor until Merck acquired it in March 2021. She holds several patents on medical devices and advises medical device companies, including Raydiant Oximetry.
“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 medical solutions.”
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