On May. 6, 2022 Forma Therapeutics Holdings, Inc.(Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported financial results for the first quarter ended March 31, 2022 (Press release, Forma Therapeutics, MAY 6, 2022, View Source [SID1234613762]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"The first quarter of 2022 was one of continued progress in enrolling ongoing trials of etavopivat and FT-7051, and also expansion into other areas where red blood cell health may play an important role," said Frank Lee, president and chief executive officer of Forma. "We also continue to strengthen our capabilities and focus on the patients we serve with the addition of talented leaders."

Key Business Updates

•Ifeyinwa (Ify) Osunkwo, M.D., MPH, joined Forma as the company’s inaugural chief patient officer and senior vice president. Dr. Osunkwo leads Forma’s efforts to be a trusted partner, collaborating with patients, advocates and healthcare providers who share a dedication to changing the care and treatment paradigm.
•Arturo Molina, M.D., elected to Board of Directors and R&D Committee. Dr. Molina is an internationally acclaimed clinician, hematology and oncology researcher, practicing physician and pioneer addressing healthcare inequities. He has over 25 years of experience in biopharma, hematology and oncology and currently serves as chief medical officer at Sutro Biopharma, where he is responsible for the clinical development of oncology and hematology therapeutics.
•Virtual Research and Development (R&D) Day to be held May 26, 2022. The company will provide an overview of its clinical development programs and research pipeline strategy, including the introduction of a new molecule currently undergoing IND-enabling studies. The live webcast will be available in the "News & Investors" section of Forma’s website.

Upcoming Milestones

•Patient enrollment in global pivotal Phase II/III trial of etavopivat for the treatment of SCD, the Hibiscus Study. The first interim analysis (IA1) in the Hibiscus Study is expected to be reached by the end of 2022. IA1 is designed to select the dose for the Phase III portion of the trial.

•Additional etavopivat development programs. Forma has initiated a Phase II trial in patients with either transfusion dependent SCD, transfusion dependent thalassemia, or non-transfusion dependent thalassemia, with initial results expected in late 2022. During 2022, Forma plans to begin clinical trials in pediatric SCD and lower-risk myelodysplastic syndrome (MDS).
•Update on FT-7051 clinical trial in mCRPC. Men with metastatic castration-resistant prostate cancer (mCRPC) continue to be enrolled in the Phase I trial. Forma plans to provide an update at its May R&D Day and further results later in 2022.
•Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma’s, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 have impacted enrollment of clinical trials and/or the ability to access sites participating in clinical trials.

Financial Results

•Cash Position: Cash, cash equivalents and marketable securities were $441.3 million as of March 31, 2022, as compared to $490.3 million as of December 31, 2021. Current cash runway is projected through the third quarter of 2024.

R&D Expenses: R&D expenses were $31.3 million for the quarter ended March 31, 2022, compared to $26.3 million for the quarter ended March 31, 2021. The increase was primarily attributable to an increase in research and development staff to support advancement of etavopivat and other programs, an increase in equity-based compensation, the conduct of our Phase II/III trial in SCD patients, and study start-up costs related to our trial in thalassemia.

General and Administrative (G&A) Expenses: G&A expenses were $13.1 million for the quarter ended March 31, 2022, compared to $9.9 million for the quarter ended March 31, 2021. The increase was primarily attributable to equity-based compensation, costs due to executive and staff hiring, and other related general and administrative costs.

Net Loss: Net loss was $44.1 million for the quarter ended March 31, 2022, compared to net loss of $36.0 million for the quarter ended March 31, 2021.

Forma will conduct a conference call and webcast May 6, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss first quarter 2022 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 1879297.

The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.