Erasca Reports First Quarter 2023 Financial Results and Business Updates
Publication of promising Phase 1b data in
ERAS-601 plus cetuximab combination was well tolerated with predominantly low-grade adverse events, supporting ‘three weeks on, one week off’ dosing regimen for ERAS-601
Clinical data readouts for HERKULES-2 (ERAS-007), HERKULES-3 (ERAS-007), and THUNDERBBOLT-1 (ERAS-801) trials planned in 2023
Strong balance sheet with cash, cash equivalents, and marketable securities of
“In 2023, we plan to further refine the developmental focus of our lead clinical programs and accelerate our transition into a late-stage clinical development company. For ERAS-601, we have identified the maximum tolerated dose for the combination with cetuximab and are pleased by the promising preliminary safety and tolerability data with reversible and manageable treatment-related adverse events (TRAEs) seen with our ‘three weeks on, one week off’ dosing regimen. Continued exploration of this combination will be prioritized in patients with human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), with initial data expected in the first half of 2024,” said
Research and Development (R&D) Highlights
- Granted FDA Fast Track Designation For ERAS-801 in Glioblastoma: In
May 2023, Erascaannounced that the United States Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to ERAS-801 (CNS-penetrant EGFR inhibitor) for the treatment of adult patients with glioblastoma (GBM) with EGFR gene alterations.
- Presented Promising Initial Phase 1b Dose Escalation Data for ERAS-601: In
April 2023, Erascapresented promising initial Phase 1b dose escalation data from FLAGSHP-1 for ERAS-601 in combination with cetuximab (ERBITUX®) in patients with advanced solid tumors as part of a poster presentation at the American Association for Cancer Research(AACR) Annual Meeting.
- Announced Publication of Phase 1b Data for Naporafenib: In
April 2023, Erascaannounced the publication of results in the Journal of Clinical Oncologyfrom the expansion arm of a Phase 1b open label trial evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST®) in patients with NRASm melanoma.
- Announced Two Poster Presentations at the 2023 ASCO Annual Meeting: In
April 2023, Erascaannounced that preliminary Phase 1b combination data for potential best-in-class ERK1/2 inhibitor ERAS-007 with encorafenib (BRAFTOVI®) and cetuximab or with palbociclib (IBRANCE®) in patients with advanced GI malignancies will be presented as part of poster presentations at the 2023 American Society of Clinical Oncology(ASCO) Annual Meeting.
- Strengthened Clinical and Regulatory Executive Leadership: In
April 2023, Erascapromoted Shannon R. Morris, M.D., Ph.D., to Chief Medical Officer, and Chandra D. Lovejoy, M.S., to Chief Regulatory Affairs Officer
Key Upcoming Milestones
- SEACRAFT-1: Phase 1b trial for naporafenib in patients with RAS Q61X tissue agnostic solid tumors
- Dosing of the first patient expected in the second half of 2023
- Initial Phase 1b combination data expected between the second and fourth quarters of 2024
- SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib in patients with NRASm melanoma
- Dosing of the first patient expected in the first half of 2024
- HERKULES-1: Phase 1b trial for ERAS-007 plus ERAS-601 in patients with advanced solid tumors
- Initial Phase 1b combination data expected in the first half of 2024
- HERKULES-2: Phase 1b trial for ERAS-007 in patients with advanced non-small cell lung cancer (NSCLC)
- Initial Phase 1b combination data expected in the second quarter of 2023
- HERKULES-3: Phase 1b trial for ERAS-007 in patients with GI malignancies
- Initial Phase 1b combination data in patients with RAS- and BRAF-mutated GI malignancies expected in the second quarter of 2023
- Phase 1b combination expansion data in patients with BRAF-mutated colorectal cancer (CRC) expected between the second half of 2023 and the first half of 2024
- FLAGSHP-1: Phase 1b trial for ERAS-601 in patients with advanced solid tumors
- Phase 1b combination data in patients with HPV-negative advanced HNSCC expected in the first half of 2024
- THUNDERBBOLT-1: Phase 1 trial for ERAS-801 in patients with recurrent glioblastoma (GBM)
- Initial Phase 1 data in patients with recurrent GBM expected in the second half of 2023
- AURORAS-1: Phase 1 trial for ERAS-3490 in patients with KRAS G12Cm NSCLC
- Initial Phase 1 data expected in 2024
First Quarter 2023 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss was
Cautionary Note Regarding Forward-Looking Statements
Selected Condensed Consolidated Balance Sheet Data
|Balance Sheet Data:|
|Cash, cash equivalents, and marketable securities||$||389,741||$||435,620|
|Total stockholders’ equity||386,452||411,853|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Three Months Ended
|Research and development||$||27,585||$||27,429|
|In-process research and development||—||2,000|
|General and administrative||9,440||7,076|
|Total operating expenses||37,025||36,505|
|Loss from operations||(37,025||)||(36,505||)|
|Other income (expense)|
|Total other income (expense), net||3,826||47|
|Net loss per share, basic and diluted||$||(0.22||)||$||(0.31||)|
|Weighted-average shares of common stock used in computing net loss per share, basic and diluted||149,504,216||119,491,433|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on marketable securities, net||527||(789||)|
ERBITUX® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
MEKINIST® is a registered trademark owned by or licensed to Novartis AG, its subsidiaries, or affiliates.
IBRANCE ® and BRAFTOVI ® are each a registered trademark owned by or licensed to Pfizer Inc., its subsidiaries, or affiliates.
Source: Erasca, Inc.