On November 10, 2021 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, 2021, and provided business updates (Press release, Erasca, NOV 10, 2021, View Source [SID1234595236]).
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"Erasca continued our strong execution this quarter, delivering on key milestones, advancing new clinical trials, and generating exciting preclinical data," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "With the initiation in September of our HERKULES-2 and -3 trials in non-small cell lung cancer and gastrointestinal malignancies, respectively, we currently have four ongoing clinical trials with multiple clinical data readouts anticipated in 2022. We are excited about recent preclinical data that further support the planned IND filings for ERAS-801 (CNS-penetrant EGFR inhibitor for refractory glioblastoma multiforme) in the first quarter of 2022 and ERAS-3490 (CNS-penetrant KRAS G12C inhibitor) in the second half of 2022."
Dr. Lim continued, "At the corporate level, we are honored to be named one of Fierce Biotech’s ‘Fierce 15’ most promising and innovative biotechnology companies of 2021. We remain focused on our mission to erase cancer and believe this mission goes beyond therapeutic development to include a broader social contribution. We were pleased to donate 1% of our pre-IPO capital stock to the Erasca Foundation in conjunction with the successful completion of our $345 million initial public offering in July. The Erasca Foundation was established to fund charitable activities designed to have a positive impact on society, particularly in underserved populations. With our strong cash position supported by top-tier institutional investors, we remain well-positioned to advance the industry’s deepest portfolio singularly focused on shutting down the RAS/MAPK pathway and to deliver on our upcoming milestones."
Research and Development (R&D) Highlights
Dosed First Patient in HERKULES-2 Trial: In September 2021, Erasca dosed the first patient in HERKULES-2, a Phase 1b/2 trial evaluating ERAS-007 (ERK1/2 inhibitor) in multiple combinations as part of Erasca’s lung cancer master protocol, with a focus on patients with advanced non-small cell lung cancer (NSCLC)
Dosed First Patient in HERKULES-3 Trial: In September 2021, Erasca dosed the first patient in HERKULES-3, a Phase 1b/2 trial evaluating ERAS-007 (ERK1/2 inhibitor) in multiple combinations as part of Erasca’s gastrointestinal cancer master protocol, with an initial focus on patients with advanced colorectal cancer (CRC)
Presented Preclinical Data for ERAS-801: In October 2021, Erasca announced the presentation of preclinical data for ERAS-801, a central nervous system (CNS)-penetrant epidermal growth factor receptor (EGFR) inhibitor for the treatment of refractory glioblastoma multiforme (GBM), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Virtual Conference on Brain Cancer
Corporate Highlights
Completed $345 Million Initial Public Offering: In July 2021, Erasca sold 21,562,500 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 2,812,500 shares of common stock, at a public offering price of $16 per share. The gross proceeds from the offering were $345 million
Named a 2021 "Fierce 15" Winner: Named one of Fierce Biotech’s "Fierce 15" most promising biotechnology companies of 2021
Entered into a Clinical Trial Collaboration and Supply Agreement with Pfizer: Pfizer will supply its BRAF inhibitor encorafenib (BRAFTOVI) at no cost in connection with a clinical proof-of-concept study evaluating ERAS-007 in combination with encorafenib and the EGFR inhibitor cetuximab for the treatment of patients with BRAF V600E-mutant metastatic CRC as part of the ongoing Phase 1b/2 HERKULES-3 trial
Contributed to the Erasca Foundation: Issued $17.5 million of common shares to the Erasca Foundation to fund charitable activities related to Erasca’s mission
Key Upcoming Milestones
ERAS-801: CNS-penetrant EGFR inhibitor
IND filing expected in first quarter of 2022
HERKULES-4: Phase 1b/2 clinical trial for ERAS-007/MAPKlamp in combination with various agents in patients with hematological malignancies
Dosing of the first patient expected in first quarter of 2022
Third Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents, and investments were $486.6 million as of September 30, 2021, as compared to $118.7 million as of December 31, 2020. During the third quarter, Erasca completed an IPO raising net proceeds of $317.0 million, after deducting underwriting discounts, commissions, and other offering expenses. Erasca expects its current cash, cash equivalents, and investments balance to fund operations for at least the next 24 months.
Research and Development (R&D) Expenses: R&D expenses were $20.0 million for the quarter ended September 30, 2021, compared to $9.1 million for the quarter ended September 30, 2020. The increase was primarily driven by expenses incurred in connection with clinical trials and preclinical studies, personnel costs due to increased headcount to support increased development activities, and outsourced services and consulting fees. Erasca also recorded $1.7 million of in-process research and development expense during the quarter ended September 30, 2021, for a milestone payment made to the University of California, San Francisco.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the quarter ended September 30, 2021, compared to $2.0 million for the quarter ended September 30, 2020. The increase was primarily driven by personnel costs, insurance costs, and legal fees. For the quarter ended September 30, 2021, $17.5 million was recorded as additional G&A expense for the common shares issued to the Erasca Foundation.
Net Loss: For the quarter ended September 30, 2021, Erasca reported a net loss of $46.1 million, inclusive of the $17.5 million in expense recorded for the common shares issued to the Erasca Foundation, or $(0.46) per basic and diluted share, compared to a net loss of $10.6 million, or $(0.50) per basic and diluted share, for the quarter ended September 30, 2020.