Forma Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

Rhea-AI Summary

Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX) reported Q1 2021 financial results, highlighting advancements in its clinical pipeline. The company completed the multiple ascending dose phase of its Phase 1 trial for FT-4202 in sickle cell disease, showing a 71% hemoglobin increase in participants. The Phase 2/3 trial, Hibiscus Study, is underway, targeting 344 patients. Additionally, the Phase 1 trial of FT-7051 for metastatic castration-resistant prostate cancer has begun. The company is also preparing a New Drug Application for olutasidenib in acute myeloid leukemia.

Positive

• 71% of participants in FT-4202 Phase 1 trial achieved hemoglobin increase ≥ 1 g/dL.
• Hibiscus Study Phase 2/3 trial enrolling approximately 344 patients to support potential accelerated approval.
• Phase 1 trial of FT-7051 for mCRPC initiated to evaluate safety and anti-tumor activity.

Negative

• None.

Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the first quarter ended March 31, 2021. The company also highlighted recent progress and upcoming milestones for its pipeline programs.

“During the first quarter, we successfully completed the multiple ascending dose portion of our Phase 1 trial in sickle cell disease, and despite challenges from the COVID-19 pandemic also began enrolling patients in the Phase 2/3 trial of FT-4202, called The Hibiscus Study, as well as in the Phase 1 trial of FT-7051 for metastatic castration resistant prostate cancer,” said Frank Lee, President and Chief Executive Officer of Forma. “We look forward to sharing additional pipeline results over the course of 2021 in our mission to transform the lives of people living with rare hematologic diseases and cancers.“

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

• MAD cohorts completed with approximately 71% of participants achieving hemoglobin increase ≥ 1 g/dL from baseline, and improvement across markers of RBC health. Doubling the dose of FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg cohort was well-tolerated with no dose-limiting toxicities or treatment-related adverse events observed. Improvements in hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin and lactate dehydrogenase) parameters were comparable to that observed with the 300 mg dose, with best response typically observed at the end of the 14-day treatment period. In the combined cohorts, 10 of 14 (71%) patients on FT-4202 achieved a hemoglobin increase ≥ 1 g/dL from baseline to Day 14. Improvement in RBC health was evidenced by increased sickle RBC survival and reduced intravascular hemolysis in patients with SCD based on a reduction in reticulocytes, bilirubin and LDH levels.
• Patient enrollment began in Phase 2/3 registrational trial, the Hibiscus Study. The Phase 2/3 Hibiscus Study is currently enrolling people living with SCD. This adaptive, randomized, placebo-controlled, double-blind, multi-center trial is expected to enroll approximately 344 adults and adolescents with SCD. FT-4202 doses of 200mg and 400mg administered once-daily are being evaluated in the Phase 2 portion of the trial. Primary endpoints in the Phase 3 portion of the trial are hemoglobin response rate at week 24 (increase of > 1 g/dL from baseline), intended to support accelerated approval, and annualized vaso-occlusive crisis rate during the 52-week blinded treatment period, which if positive is expected to support full approval.

CPB/p300 Program in Prostate Cancer:

• FT-7051 Phase 1 clinical trial initiated for the treatment of mCRPC. In January 2021, Forma announced that the first patient was dosed in the ongoing Phase 1 clinical trial evaluating FT-7051 for the treatment of mCRPC. The trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (prostate specific antigen (PSA) and radiographic responses), and pharmacokinetics/pharmacodynamics (PK/PD) of FT-7051 in men with mCRPC who have progressed despite prior therapy with at least one anti-androgen therapy. The trial will include genetic mutation analysis to identify the basis of resistance to standard-of-care and will also evaluate expression of the AR-v7 splice variant, for which there are no approved therapies. The trial utilizes an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information, as well as to identify biomarkers of clinical benefit such as PSA response.

IDH1 Program in AML and Glioma:

• Olutasidenib NDA preparation for R/R AML. With the conclusion of the Phase 2 R/R AML trial, Forma has begun preparing an NDA for submission to the U.S. Food and D

FAQ

What were the financial results for Forma Therapeutics in Q1 2021?

Forma Therapeutics reported financial results for Q1 2021, highlighting progress in clinical trials without specific revenue figures provided.

What are the milestones for FT-4202 in sickle cell disease?

FT-4202's Phase 1 trial showed a 71% hemoglobin increase, and the Phase 2/3 Hibiscus Study is currently enrolling patients.

What is the purpose of the FT-7051 Phase 1 trial?

The FT-7051 Phase 1 trial aims to evaluate safety, tolerability, and preliminary anti-tumor activity in patients with metastatic castration-resistant prostate cancer.

Is Forma Therapeutics preparing any New Drug Applications?

Yes, Forma is preparing a New Drug Application for olutasidenib for the treatment of relapsed/refractory acute myeloid leukemia.