On May 12, 2022 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 March 31, 2022, and provided business updates (Press release, Erasca, MAY 12, 2022, View Source [SID1234614351]).
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"This quarter, we continued to advance our pipeline well. In addition to progressing our ERK1/2 inhibitor ERAS-007 and our SHP2 inhibitor ERAS-601 in their respective clinical trials, we also achieved first patient dosing for our CNS-penetrant EGFR inhibitor ERAS-801," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "We presented preclinical data in six posters at this year’s AACR (Free AACR Whitepaper) meeting supporting the clinical development of our potentially best-in-class programs, including ERAS-007, ERAS-601, and ERAS-3490 (CNS-penetrant KRAS G12C inhibitor). We were delighted to host a webinar with Dr. Scott Kopetz from MD Anderson Cancer Center discussing the unmet need and therapeutic opportunities targeting cancers driven by the RAS/MAPK pathway, with a particular focus in gastrointestinal cancers."
Dr. Lim continued, "We remain on track to report Phase 1b monotherapy data for ERAS-007 in HERKULES-1 and Phase 1 monotherapy data for ERAS-601 in FLAGSHP-1 in the second half of 2022. These data will include preliminary monotherapy safety and pharmacokinetics to support dose selection for combinations of ERAS-007 and ERAS-601. We also remain on track to file an IND for ERAS-3490 in the second half of 2022. As we look ahead, our pipeline continues to demonstrate encouraging therapeutic potential, our cash position remains strong, and we are highly focused on continued execution throughout the year."
Research and Development Highlights
Dosed First Patient in THUNDERBBOLT-1 Trial: In February 2022, Erasca dosed the first patient in THUNDERBBOLT-1, a Phase 1 trial evaluating ERAS-801 for the treatment of recurrent glioblastoma multiforme (rGBM)
Presented Six Posters at the 2022 AACR (Free AACR Whitepaper) Annual Meeting: In April 2022, Erasca presented six poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These posters featured data supporting the clinical development of programs with best-in-class potential, including ERK1/2 inhibitor ERAS-007, SHP2 inhibitor ERAS-601, and central nervous system (CNS)-penetrant KRAS G12C inhibitor ERAS-3490
Hosted KOL Investor Webinar on AACR (Free AACR Whitepaper) Data: In April 2022, Erasca hosted an investor webinar highlighting its 2022 AACR (Free AACR Whitepaper) presentations and featuring a presentation by key opinion leader (KOL) Scott Kopetz, M.D., Ph.D., of MD Anderson Cancer Center
Corporate Highlights
Strengthened Executive Leadership: In January 2022, Erasca appointed Lisa Tesvich-Bonora, Ph.D., as Chief People Officer and promoted Robert Shoemaker, Ph.D., to Senior Vice President of Research
Entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with Lilly: In March 2022, Erasca announced that it had entered into a CTCSA under which Lilly will supply its EGFR inhibitor cetuximab (ERBITUX) at no cost in connection with a clinical proof-of-concept study evaluating ERAS-007 in combination with the BRAF inhibitor encorafenib and cetuximab for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (CRC) as part of the ongoing Phase 1b/2 HERKULES-3 trial. This agreement complements the CTCSA previously entered into with Pfizer for Pfizer’s BRAF inhibitor encorafenib (BRAFTOVI)
Expanded Board of Directors: In April 2022, Erasca appointed Jean Liu to its board of directors and to its audit committee
Opened New Corporate Headquarters: In April 2022, Erasca opened its new corporate headquarters in San Diego, CA, to accommodate and unify an expanded employee base
Key Upcoming Milestones
HERKULES-1: Phase 1b/2 trial for ERAS-007 in patients with advanced solid tumors
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Initial Phase 1b monotherapy data expected in second half of 2022
HERKULES-3: Phase 1b/2 trial for ERAS-007 in patients with gastrointestinal malignancies
Initial Phase 1b combination data expected between the fourth quarter of 2022 and the first half of 2023
FLAGSHP-1: Phase 1/1b trial for ERAS-601 in patients with advanced solid tumors
Initial Phase 1 monotherapy data expected in second half of 2022
Initial Phase 1b combination data in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC expected between the fourth quarter of 2022 and the first half of 2023
ERAS-3490: CNS-penetrant KRAS G12C inhibitor
IND filing expected in second half of 2022
First Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were $421.8 million as of March 31, 2022, compared to $459.2 million as of December 31, 2021. Erasca expects its current cash, cash equivalents, and marketable securities to fund operations into the second half of 2024.
Research and Development (R&D) Expenses: R&D expenses were $27.4 million for the quarter ended March 31, 2022, compared to $12.2 million for the quarter ended March 31, 2021. The increase was primarily driven by expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, personnel costs due to increased headcount to support increased development activities, stock-based compensation expense, and outsourced service and consulting fees. Erasca also recorded
$2.0 and $3.7 million of in-process R&D expense during the quarters ended March 31, 2022 and 2021, respectively, for upfront and milestone payments and stock issuances under certain of our acquisition and license agreements.
General and Administrative (G&A) Expenses: G&A expenses were $7.1 million for the quarter ended March 31, 2022, compared to $3.7 million for the quarter ended March 31, 2021. The increase was primarily driven by stock-based compensation expense, insurance costs, personnel costs, and facilities and related costs.
Net Loss: For the quarter ended March 31, 2022, Erasca reported a net loss of $36.5 million, or $(0.31) per basic and diluted share, compared to a net loss of $18.0 million, or $(0.81) per basic and diluted share, for the quarter ended March 31, 2021.