On November 9, 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 September 30, 2022, and provided business updates (Press release, Erasca, NOV 9, 2022, View Source [SID1234623553]).
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"This quarter, we continued to advance our RAS/MAPK pathway-focused pipeline. In September, we reported promising preliminary Phase 1/1b data at our R&D Day for our two lead compounds, ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601, in advanced solid tumors. Their monotherapy efficacy combined with favorable safety, tolerability, and pharmacokinetic data support their combination development. In July, we signed a second clinical trial collaboration and supply agreement (CTCSA) with Eli Lilly to explore the anti-EGFR antibody cetuximab with ERAS-601 for the treatment of triple wildtype (KRAS/NRAS/BRAF wildtype) metastatic colorectal cancer (CRC) and human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC), followed last month by a second CTCSA with Pfizer to explore the CDK4/6 inhibitor palbociclib with ERAS-007 for the treatment of patients with KRAS- or NRAS-mutant CRC and KRAS-mutant pancreatic ductal adenocarcinoma (PDAC)," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "We were also pleased to share four poster presentations at last month’s 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on ERAS-007, ERAS-601, our central nervous system (CNS)-penetrant EGFR inhibitor ERAS-801, and our KRAS G12D inhibitor program ERAS-4."
Dr. Lim continued, "Before year-end, we expect to file an IND for our CNS-penetrant KRAS G12C inhibitor ERAS-3490 in KRAS G12C mutant non-small cell lung cancer (NSCLC). In the first half of 2023, we anticipate initiating a dose escalation trial for ERAS-007 in combination with ERAS-601 and expect to report combination data for ERAS-007 in gastrointestinal malignancies and ERAS-601 in triple wildtype CRC. Our balance sheet remains strong, we continue to strategically advance our pipeline, and we remain on track to execute across our near-term catalysts."
Research and Development (R&D) Highlights
Presented Promising Phase 1/1b Data for ERAS-007 and ERAS-601: In September 2022, Erasca hosted a virtual R&D Day with key opinion leader David S. Hong, M.D., professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, presenting promising preliminary Phase 1/1b monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor
ERAS-601 in RAS/MAPK-altered solid tumors, including a subset of BRAF-driven solid tumors and highlighting future directions for ERAS-007 and ERAS-601 in advanced solid tumors. Twenty-three percent (6/26) of patients with RAS/MAPK-altered non-CRC solid tumors and 44% (4/9) with BRAF-driven non-CRC solid tumors responded (confirmed and unconfirmed partial responses) to single agent ERAS-007 or ERAS-601*
Four Poster Presentations at ENA Symposium: In October 2022, Erasca presented four poster presentations supporting the continued clinical development of ERK1/2 inhibitor ERAS-007, SHP2 inhibitor ERAS-601, CNS-penetrant EGFR inhibitor ERAS-801, and KRAS G12D inhibitor program ERAS-4
* Data cutoff dates of 11/6/20, 7/11/22, and 5/16/22 for ASN007-101, FLAGSHP-1, and HERKULES-1 trials, respectively.
Corporate Highlights
Expanded Geographical Footprint: In July 2022, Erasca opened its new location in South San Francisco, CA, to accommodate and unify its Northern California employee base
Entered into a CTCSA with Eli Lilly (Lilly): In July 2022, Erasca announced that it had entered into a CTCSA under which Lilly will supply its anti-EGFR inhibitor cetuximab (ERBITUX) at no cost in connection with a clinical proof-of-concept trial evaluating ERAS-601, Erasca’s oral SHP2 inhibitor, in various combinations, including with cetuximab for the treatment of triple wildtype (KRAS/NRAS/BRAF wildtype) metastatic CRC and HPV-negative advanced HNSCC as part of the ongoing Phase 1/1b FLAGSHP-1 trial. This CTCSA complements the CTCSAs Erasca previously entered into with Lilly and Pfizer, respectively, to evaluate cetuximab and encorafenib (BRAFTOVI) in combination with the ERK1/2 inhibitor ERAS-007 in the HERKULES-3 Phase 1b/2 trial
Entered a Strategic R&D Collaboration with MD Anderson: In August 2022, Erasca announced a strategic R&D collaboration with MD Anderson to evaluate multiple agents from Erasca’s pipeline targeting the RAS/MAPK pathway as either single-agent or combination therapies
Entered into a CTCSA with Pfizer: In October 2022, Erasca announced that it had entered into a CTCSA under which Pfizer will supply its CDK4/6 inhibitor palbociclib (IBRANCE) at no cost in connection with a clinical proof-of-concept trial evaluating ERAS-007 in combination with palbociclib for the treatment of patients with KRAS- or NRAS-mutant CRC and KRAS-mutant PDAC as part of the ongoing Phase 1b/2 HERKULES-3 trial in patients with gastrointestinal (GI) malignancies
Key Upcoming Milestones
ERAS-3490: CNS-penetrant KRAS G12C inhibitor
IND filing anticipated in the second half of 2022
HERKULES-1: Phase 1b/2 trial for ERAS-007/MAPKlamp in patients with advanced solid tumors
Initiation of a Phase 1b dose escalation trial for ERAS-007 in combination with ERAS-601 (Erasca’s first MAPKlamp approach) anticipated in the first half of 2023
HERKULES-3: Phase 1b/2 trial for ERAS-007 in patients with GI malignancies
Initial Phase 1b combination data anticipated in the first half of 2023
FLAGSHP-1: Phase 1/1b trial for ERAS-601 in patients with advanced solid tumors
Initial Phase 1b combination data in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC anticipated in the first half of 2023
HERKULES-2: Phase 1b/2 trial for ERAS-007 in patients with advanced NSCLC
Initial Phase 1b combination data anticipated in 2023
Third Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were $365.5 million as of September 30, 2022, compared to $459.2 million as of December 31, 2021. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2024.
Research and Development (R&D) Expenses: R&D expenses were $28.2 million for the quarter ended September 30, 2022, compared to $20.0 million for the quarter ended September 30, 2021. The increase was primarily driven by expenses incurred in connection with clinical trials, preclinical studies, discovery activities, facilities-related expenses and depreciation, stock-based compensation, and outsourced services and consulting fees. The quarter ended September 30, 2021 also included $1.7 million of in-process R&D expenses related to the cash payment of $1.7 million to The Regents of the University of California, San Francisco following the completion of Erasca’s IPO.
General and Administrative (G&A) Expenses: G&A expenses were $8.8 million for the quarter ended September 30, 2022, compared to $6.9 million for the quarter ended September 30, 2021. The increase was primarily driven by stock-based compensation, legal and accounting fees, and facilities and office-related expenses. The quarter ended September 30, 2021 also included recognition of $17.5 million of expenses related to the issuance of common stock as a contribution to the Erasca Foundation in conjunction with Erasca’s IPO.
Net Loss: Net loss was $35.5 million, or $(0.29) per basic and diluted share, for the quarter ended September 30, 2022, compared to $46.1 million, inclusive of the $17.5 million in expenses recorded for the common stock issued to the Erasca Foundation, or $(0.46) per basic and diluted share, for the quarter ended September 30, 2021.