SAN DIEGO, Aug. 12, 2024 -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company focused on RAS/MAPK pathway-driven cancers, announced business updates and financial results for the second fiscal quarter ending June 30, 2024.
Erasca’s CEO, Dr. Jonathan E. Lim, highlighted the transformative nature of the second quarter, driven by the in-licensing of promising RAS-targeting molecules and the initiation of the SEACRAFT-2 Phase 3 trial for naporafenib. These developments, combined with effective financial strategies, have significantly extended the company's cash runway.
Naporafenib combined with trametinib has shown promising results in Phase 1 and 2 trials for NRAS-mutant melanoma, demonstrating notable improvements in progression-free survival and overall survival. The SEACRAFT-1 Phase 1b trial is expected to provide initial combination data for RAS Q61X solid tumors by the fourth quarter of 2024.
Dr. Lim emphasized the expanded pipeline, which now includes ERAS-0015, a pan-RAS molecular glue, and ERAS-4001, a pan-KRAS inhibitor. These preclinical candidates have the potential to address significant unmet needs in around 2.7 million annual global diagnoses of RAS-mutant tumors.
Key Research and Development Highlights:
- SEACRAFT-2 Pivotal Phase 3 Trial: Initiated in June 2024, this global trial is evaluating naporafenib in combination with trametinib (MEKINIST®) for NRASm melanoma. The trial's two-stage design aims to provide randomized data against trametinib monotherapy in 2025 and will inform the randomized Phase 2 dose for the combination. The second stage will compare the combination with physician’s choice of chemotherapy or a single-agent MEK inhibitor, using progression-free survival and overall survival as primary endpoints for regulatory approval.
Corporate Developments:
- In May 2024, Erasca secured exclusive license agreements for two preclinical RAS programs: the pan-RAS molecular glue ERAS-0015 and the pan-KRAS inhibitor ERAS-4001. These molecules are seen as potentially best-in-class and first-in-class, respectively, and are designed to address the needs of patients with RASm and KRASm tumors.
- Erasca extended its financial runway into the first half of 2027 through two significant equity financings. A $45 million private placement in March 2024, followed by a $184 million underwritten offering in May 2024, raised substantial funds to support ongoing operations and development activities.
Upcoming Milestones:
- SEACRAFT-1: Initial Phase 1b combination efficacy data for naporafenib plus trametinib in RAS Q61X solid tumors is expected by Q4 2024.
- SEACRAFT-2: Phase 3 Stage 1 data for naporafenib plus trametinib in NRASm melanoma is anticipated in 2025.
- AURORAS-1: IND filing for ERAS-0015 in RASm solid tumors is expected in the first half of 2025, with initial Phase 1 monotherapy data in 2026.
- BOREALIS-1: IND filing for ERAS-4001 in KRASm solid tumors is expected in Q1 2025, with initial Phase 1 monotherapy data in 2026.
Second Quarter 2024 Financial Results:
- As of June 30, 2024, Erasca’s cash, cash equivalents, and marketable securities totaled $460.2 million, up from $322.0 million as of December 31, 2023. This increase was primarily due to recent equity financings.
- Research and development expenses for the quarter were $33.0 million, up from $26.2 million in the same period in 2023. The rise was largely due to increased costs associated with clinical trials, preclinical studies, and personnel expenses related to a workforce reduction.
- General and administrative expenses rose to $12.3 million from $9.8 million in the previous year, mainly due to higher legal fees and impairment charges.
- The net loss for the second quarter of 2024 was $63.2 million, or $(0.29) per share, compared to a net loss of $31.8 million, or $(0.21) per share, for the same period in 2023.
Erasca is dedicated to erasing cancer through its focused approach on RAS/MAPK pathway-driven cancers, leveraging its deep pipeline and expert scientific advisory board to develop novel therapies for patients.
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