Female Oriented Healthcare Advances with Focus on Permanent Birth Control and Infertility, Clinical Trials Underway: Femasys (NASDAQ: FEMY)
– Commitment and Company Focus on Transforming Women’s Healthcare.
– Completed Initial Public Offering Raising Net Proceeds of $31.6 Million.
– Intellectual Property Portfolio with Over 100 Patents Globally.
– Developing Advanced Treatments for Permanent Birth Control & Infertility.
– Medical Industry Veteran Edward Evantash, M.D. as Chief Medical Officer.
– Initiated 792-Patient, Pivotal LOCAL Trial After Receipt of Investigational Device Exemption Submission Approval on Infertility Treatment FemaSeed.
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 is involved in clinical trials 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.
– Appointment of Edward Evantash, M.D. as Chief Medical Officer
On September 1st FEMY announced the appointment of Edward G. Evantash, M.D., as chief medical officer. Dr. Evantash brings over two decades of industry experience in medical and clinical affairs to FEMY, having previously served as chief medical officer of Alydia Health and vice president of medical affairs at Hologic, Inc., both medical technology companies focused on women’s healthcare. He will be responsible for providing leadership and direction for Femasys’ pipeline of clinical development programs.
During his time at Alydia and Hologic, Dr. Evantash was responsible for applying his expertise in clinical study strategy and execution as well as key opinion leader engagement, and in providing strategy and execution on clinical studies for FDA submissions. At Hologic, he developed and managed product lifecycle publication pipelines, identified customer knowledge gaps and created engaging programs to overcome barriers to commercial success, and aligned with the healthcare economics team to recognize the changing reimbursement landscape and create a related strategy.
Before entering industry, Dr. Evantash served as chief of the division of general obstetrics and gynecology at Tufts Medical Center. In addition, he held faculty appointments at Tufts University School of Medicine, Northeastern University and Harvard Medical School. He has published numerous peer-reviewed papers and book chapters in obstetrics and gynecology. Dr. Evantash served as chief resident at The Johns Hopkins Hospital in the Department of Gynecology and Obstetrics when completing his residency training. He earned his M.D. from the University of Pennsylvania School of Medicine and graduated cum laude with a B.A. in biology from Brandeis University.
– Financial Results and Review for the Second Quarter of 2021
On August 11th FEMY announced financial results for the second quarter and six months ended June 30, 2021 which included the following:
Recent Corporate Developments
– On June 17, 2021, FEMY 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 FEMY from the offering, after deducting the underwriting discounts and commissions and legal expenses, totaled $31,613,500. FEMY shares began trading on the Nasdaq Capital Market on June 18, 2021. The offering closed on June 22, 2021.
– On June 24, 2021, FEMY announced the appointment of Anne Morrissey to the company’s board of directors. Ms. Morrissey brings decades of experience to FEMY. Most recently, Anne served as President and Chief Executive Officer of Alydia Health from 2016 to 2020, and thereafter as an advisor until it was acquired by Merck in March 2021. She holds several patents on medical devices and advises medical device companies, including Raydiant Oximetry.
Recent Developments Related to Clinical Programs
– On April 8, 2021, FEMY 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, FEMY 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.
Second Quarter (Three-Months) 2021 Financial Results:
– Research and Development expenses increased 0.7%, to $894,868 for the second quarter of 2021 compared the second quarter of 2020. The increase was primarily due to compensation and personnel related costs, an increase in clinical-related costs related to FemBloc studies, but was offset by decreases in material and development costs and other costs.
– General and Administrative expenses increased by $507,774, or 93.4% to $1,051,399 for the second quarter of 2021 compared to the second quarter of 2020. The increase was primarily due to an increase of $412,076 in professional costs associated with the company’s financing transactions and other administrative costs, such as insurance.
– Sales of the Company’s FemVue product, increased by $142,772, or 77.9%, to $326,006 from $183,234 for the second quarter of 2021. The net sales increase accounted for a decrease in sales for the three-months ending June 30, 2020 due to impacts of the COVID-19 pandemic. U.S. sales comprised a 46.3% increase for the second quarter of 2021 compared to the same period last year.
– Primarily reflecting the factors noted above, net loss was $1,083,059, or $0.52 per diluted share, for the second quarter of 2021, compared to $1,485,451, or $1.55 per diluted for the second quarter of 2020.
– The cash and cash equivalents balance as of June 30, 2021 was $29,858,868. FEMY expects, based on its current operating plan, that its existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operations at least through 2022.
Year to Date 2021 (Six-Months) Financial Results:
– Research and Development expenses decreased by $349,512, or 15.6% to $1,889,890 for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The decrease was primarily due to the decrease of $170,249 in compensation and related personnel costs due to the reduction in staff in March 2020, along with a decrease in clinical-related costs related to FemBloc studies and decreases in material and development costs.
– General and Administrative expenses increased by $749,569, or 62.8%, to $1,943,386 for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was largely due to an increase of $740,734 in professional costs associated with the Company’s financing transactions.
– Sales of the FEMY FemVue product increased by $212,035, or 47.8%, to $655,781 from $443,746 for the six-months ended June 30, 2020. The increase was attributed to a $156,240 increase in U.S. sales and a $55,795 increase in international sales, primarily due to the impacts of the COVID-19 pandemic.
– Primarily reflecting the factors noted above, net loss decreased to $2,913,291, or $1.89 per diluted share, for the six months ended June 30 2021, as compared to a net loss of $3,687,178, or $3.86 per diluted share, for the six months ended June 30, 2020.
– First Patient Treated in Pivotal Trial for FemaSeed
On July 20th FEMY announced the initiation and first patient treated in a pivotal trial evaluating FemaSeed, a first in class, localized directional insemination product candidate for infertility.
“For more than 20 years, current approaches to infertility treatment have been limited during the initial stage of therapeutic care, but with the advancement of FemaSeed, we believe a next generation intrauterine procedure may have the opportunity to truly change this traditional paradigm,” said Michael Glassner, MD, Founding Partner and Medical Director of Main Line Fertility & Reproductive Medicine in Pennsylvania, where the first patient in the LOCAL trial was treated in July 2021. “The LOCAL trial is the next step in proving the FemaSeed localized directional insemination approach. My colleagues and I are thrilled to be a part of this patient care evolution.”
“Infertility has become a global issue and the commencement of the LOCAL trial underscores our commitment to ensure that women struggling to become pregnant receive the best, lowest cost treatment option by developing our innovative directional delivery platform technology,” said Kathy Lee-Sepsick, founder, President & Chief Executive Officer of FEMY.
For more information on Femasys, Inc. (NASDAQ: FEMY) visit: https://www.femasys.com.
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