On May 8, 2024 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and provided financial results for the fiscal quarter ended March 31, 2024 (Press release, Erasca, MAY 8, 2024, View Source [SID1234642875]).
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"We started 2024 strong with compelling survival data from a pooled analysis of mature data for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma, which showed a near doubling of median overall survival (mOS) versus comparable historical controls," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "These data also catalyzed an oversubscribed $45 million financing from new and existing high-quality investors. We are excited about the potential of this combination to improve both progression free survival and overall survival in patients with aggressive melanoma in need of additional treatment options."
Dr. Lim continued, "Throughout the year, we expect several data readouts across our clinical programs, including naporafenib (SEACRAFT-1), ERAS-007 (HERKULES-3), and ERAS-801 (THUNDERBBOLT-1). We also expect to initiate our pivotal SEACRAFT-2 trial evaluating naporafenib in the second quarter, with a randomized readout from Stage 1 of the Phase 3 trial anticipated in 2025. With our recent capital infusion and robust balance sheet, we believe that we have extended our cash runway into the second half of 2026 through multiple key inflection points."
Research and Development (R&D) Highlights
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Analysis of mOS Data for Naporafenib: In March 2024, a pooled analysis of patients with NRASm melanoma dosed with the combination of naporafenib and trametinib (MEKINIST) at two different doses across two different trials (Phase 1b and Phase 2) showed a mOS of 13.0 and 14.1 months, respectively. The pooled dataset at each dose compares favorably relative to historical benchmarks.
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Hosted an R&D Update Conference Call: In March 2024, Erasca provided updates on the Company’s lead clinical program, naporafenib, and its preclinical ERAS-4 program focused on the development of compounds targeting KRAS-mutant solid tumors.
Corporate Highlights
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Extended Cash Runway with $45 Million Private Placement Financing: In March 2024, Erasca entered into an oversubscribed private placement led by high-quality new and existing healthcare-focused investors, which closed in April 2024 (2024 Private Placement), that extended its expected cash runway into the second half of 2026.
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Entered into Two CTCSAs with Novartis for Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2: In February 2024, Erasca announced two clinical trial collaboration and supply agreements (CTCSAs) with Novartis pursuant to which Novartis will provide its MEK inhibitor trametinib at no cost to Erasca in connection with two clinical trials evaluating naporafenib in combination with trametinib for the treatment of patients with RAS Q61X solid tumors as part of the ongoing Phase 1b SEACRAFT-1 trial, and for the treatment of patients with previously treated NRASm unresectable or metastatic melanoma as part of the planned randomized pivotal Phase 3 SEACRAFT-2 trial.
Key Upcoming Milestones
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SEACRAFT-1: Phase 1b trial for naporafenib (pan-RAF inhibitor) plus trametinib in patients with RAS Q61X tissue agnostic solid tumors
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Initial Phase 1b combination data expected between the second and fourth quarters of 2024
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SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
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Phase 3 trial initiation expected in the second quarter of 2024
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Randomized readout from Stage 1 of the Phase 3 trial expected in 2025
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HERKULES-3: Phase 1b trial for ERAS-007 (ERK inhibitor) plus encorafenib (BRAFTOVI) + cetuximab (ERBITUX) (EC) in EC-naïve patients with BRAF-mutant (BRAFm) colorectal cancer (CRC)
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Phase 1b combination data expected in the second quarter of 2024
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THUNDERBBOLT-1: Phase 1 trial for ERAS-801 (CNS-penetrant EGFR inhibitor) in patients with EGFR-amplified recurrent glioblastoma (GBM)
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Initial Phase 1 monotherapy data expected in 2024
First Quarter 2024 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were $297.7 million as of March 31, 2024, compared to $322.0 million as of December 31, 2023. Erasca expects its pro forma cash, cash equivalents, and marketable securities balance of $334 million (inclusive of the net proceeds received from the 2024 Private Placement) to fund operations into the second half of 2026.
Research and Development (R&D) Expenses: R&D expenses were $28.6 million for the quarter ended March 31, 2024, compared to $27.6 million for the quarter ended March 31, 2023. The increase was primarily driven by an increase in expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, partially offset by a decrease in outsourced services and consulting fees.
General and Administrative (G&A) Expenses: G&A expenses were $10.3 million for the quarter ended March 31, 2024, compared to $9.4 million for the quarter ended March 31, 2023. The increase was primarily driven by increases in legal fees and personnel costs, including stock-based compensation expense.
Net Loss: Net loss was $35.0 million, or $(0.23) per basic and diluted share, for the quarter ended March 31, 2024, compared to $33.2 million, or $(0.22) per basic and diluted share, for the quarter ended March 31, 2023.