On November 9, 2023 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 financial results for the fiscal quarter ended September 30, 2023, and provided business updates (Press release, Erasca, NOV 9, 2023, View Source [SID1234637361]).
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"In 2023, we have continued to make exciting progress across our pipeline," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "In August, we dosed the first patient with naporafenib (pan-RAF inhibitor) in combination with trametinib in our SEACRAFT-1 Phase 1b trial in patients with RAS Q61X tissue agnostic solid tumors. We identified promising activity in our HERKULES-3 signal-seeking study of ERAS-007 (ERK inhibitor) in combination with encorafenib and cetuximab (EC) in EC-naïve patients with BRAF-mutated (BRAFm) colorectal cancer (CRC) using a flexible BID-QW dosing regimen, reinforcing ERAS-007’s potential as a backbone of combination therapy. Our robust balance sheet and cash runway into the second half of 2025 position us well to report on multiple near-term readouts from our ongoing clinical programs."
Research and Development (R&D) Highlights
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Dosed First Patient in SEACRAFT-1 Phase 1b Trial for Naporafenib: In August 2023, Erasca dosed the first patient in the SEACRAFT-1 Phase 1b trial evaluating naporafenib (pan-RAF inhibitor) in combination with trametinib (MEK inhibitor, MEKINIST) in patients with RAS Q61X tissue agnostic solid tumors.
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 NRAS-mutated melanoma
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Dosing of the first patient expected in the first half of 2024
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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 BRAFm CRC
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Phase 1b combination expansion data in patients with BRAFm CRC expected between the second half of 2023 and the first half of 2024
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FLAGSHP-1: Phase 1b trial for ERAS-601 (SHP2 inhibitor) in patients with advanced solid tumors
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Phase 1b combination expansion data in relevant patient populations, including patients with human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC), expected in the first half of 2024
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THUNDERBBOLT-1: Phase 1 trial for ERAS-801 (central nervous system (CNS)-penetrant EGFR inhibitor) in patients with recurrent glioblastoma (GBM)
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Initial Phase 1 monotherapy dose escalation data in patients with recurrent GBM expected in the second half of 2023
Third Quarter 2023 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were $343.6 million as of September 30, 2023, compared to $435.6 million as of December 31, 2022. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2025.
Research and Development (R&D) Expenses: R&D expenses were $25.2 million for the quarter ended September 30, 2023, compared to $28.2 million for the quarter ended September 30, 2022. The decrease was primarily driven by decreases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities, and outsourced services and consulting fees, as a result of pipeline prioritization, partially offset by increases in personnel costs, including stock-based compensation expense.
General and Administrative (G&A) Expenses: G&A expenses were $9.4 million for the quarter ended September 30, 2023, compared to $8.8 million for the quarter ended September 30, 2022. The increase was primarily driven by personnel costs, including stock-based compensation expense, partially offset by decreases in legal and accounting fees.
Net Loss: Net loss was $30.4 million, or $(0.20) per basic and diluted share, for the quarter ended September 30, 2023, compared to $35.5 million, or $(0.29) per basic and diluted share, for the quarter ended September 30, 2022.