On August 13, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported financial results for the second quarter ended June 30, 2020 (Press release, Forma Therapeutics, AUG 13, 2020, View Source [SID1234563573]). The Company also highlighted recent progress and upcoming milestones for its pipeline programs.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This year, to date, has been very productive for Forma. We completed an upsized initial public offering, which will allow us to advance both our core assets, FT-4202, a potentially foundational, disease-modifying therapy for patients with sickle cell disease, and FT-7051, in development for mCRPC with the potential to address prostate cancer cell resistance related to molecular alterations in androgen receptors. In addition, our board of directors welcomed Dr. Wayne Frederick, who is not only a distinguished doctor and president of Howard University but also lives with sickle cell disease," said Frank Lee, president and chief executive officer of Forma Therapeutics. "We look forward to continuing Forma’s momentum by providing several clinical updates before the end of the year, including topline data from our FT-4202 multiple ascending dose study and interim data from a non-core asset, olutasidenib, Phase 2 clinical trial in patients with relapsed/refractory acute myeloid leukemia."
Key Business and Clinical Highlights
PKR Program in Sickle Cell Disease (SCD):
Received FDA Orphan Drug Designation for FT-4202 in Sickle Cell Disease. FT-4202 is being evaluated in a randomized, multi-center, placebo-controlled Phase 1 trial in SCD patients ages 12 years and older and has been granted fast track, rare pediatric and orphan drug designations. FT-4202 is a potent activator of pyruvate kinase-R (PKR) designed to improve red blood cell (RBC) metabolism, function and survival by decreasing 2,3 DPG and increasing ATP, potentially resulting in both increased hemoglobin levels and reduced vaso-occlusive crises.
Reported Favorable Single Dose Cohort Data of Patients with SCD at EHA (Free EHA Whitepaper): Results presented at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in June 2020 demonstrated a favorable tolerability profile and biologic effects of FT-4202, with evidence of pharmacodynamic activity translating into increased oxygen affinity, a shift in the point of sickling to lower oxygen tensions, improved membrane deformability of sickle RBCs and an increased hemoglobin (on average 0.9 g/dL vs. placebo) at 24 hours post-single dose. These initial findings supported the initiation of the multiple ascending dose cohort in patients with SCD and continued planning for the global Phase 2/3 trial in SCD patients.
CPB Program in Prostate Cancer:
Presented Data Demonstrating Antitumor Activity of a Potent and Selective Inhibitor of CBP/p300 at AACR (Free AACR Whitepaper): Forma presented preclinical data on FT-6876, a predecessor molecule to clinical development candidate FT-7501, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in June 2020 that demonstrated antitumor activity in androgen receptor (AR)-dependent breast cancer cell lines and highlighted the possible role of CREB-binding protein/E1A binding protein p300 (CBP/p300) in proliferation and survival of AR-independent tumors. Inhibition of CBP/p300 in vitro can suppress AR and AR-v7 driven transcription of genes that drive the growth of prostate cancer cells.
FDA Cleared Investigational New Drug application for FT-7051. In April 2020, the FDA cleared Forma’s investigational new drug application for FT-7051. We expect to initiate a Phase 1 trial in mCRPC patients in the fourth quarter of 2020.
IDH1 Program in AML and Glioma:
Announced Positive IDH1 Inhibitor Data for Olutasidenib in Glioma at ASCO (Free ASCO Whitepaper): Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, predominantly enhancing glioma at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), suggesting the potential for response and prolonged disease control in both non-enhancing and enhancing phenotypes of relapsed/refractory IDH1-mutated glioma patients. Olutasidenib is a selective inhibitor for cancers with IDH1 mutations and is being evaluated in a registrational Phase 2 trial for relapsed/refractory acute myeloid leukemia (R/R AML) and an exploratory Phase 1 trial for glioma and other IDH1m solid tumor indications.
Corporate:
Completed Upsized Initial Public Offering: In June 2020, Forma completed an upsized IPO of 15,964,704 shares of common stock, including the full exercise of the underwriter’s over-allotment option, resulting in gross proceeds of approximately $319.3 million before deducting underwriting discounts and commissions and other offering expenses.
Strengthened Executive Team with Appointment of David N. Cook, Ph.D., as Chief Scientific Officer
Transitioned Board of Directors Composition: Following Forma’s IPO, Dr. Steve Hall departed the board of directors and Dr. Wayne A. I. Frederick joined.
Upcoming Milestones
Updated Data to Inform Pivotal Trial in SCD: Forma plans to announce topline data from the ongoing trial of FT-4202 in SCD patients in the fourth quarter of 2020, including data from multiple ascending dose cohorts. The results of this trial will inform a global pivotal Phase 2/3 trial for people living with SCD, which is expected to initiate in the first half of 2021.
Initiation of Clinical Development in mCRPC: We continue to make progress to initiate a Phase 1 trial of FT-7051 in mCRPC patients in the fourth quarter of 2020.
Additional Data from Non-core IDH1 Program: Forma plans to announce topline data from a second interim analysis of the registrational cohort of an olutasidenib trial in relapsed/refractory AML (R/R AML) in the fourth quarter of 2020.
Possibility of COVID-19 Impact: The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.
Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $414.3 million as of June 30, 2020, as compared to $173.2 million as of December 31, 2019.
Research and Development (R&D) Expenses: R&D expenses were $20.5 million for the quarter ended June 30, 2020, compared to $28.1 million for the quarter ended June 30, 2019. The decrease was primarily due to planned reductions in spending on FT-2101, FT-4101, FT-8225, research, as well as internal R&D personnel-related costs, which were partially offset by increases in FT-4202 expenses to conduct the Phase 1 trial and preparations for our planned pivotal Phase 2/3 trial.
General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the quarter ended June 30, 2020, compared to $5.7 million for the quarter ended June 30, 2019. The increase was primarily due to increases in professional fees and stock-based compensation, partially offset with lower personnel-related costs.
Net Income/Loss: Net loss was $25.4 million for the quarter ended June 30, 2020, compared to $14.8 million for the quarter ended June 30, 2019.