Erasca Reports Second Quarter 2022 Financial Results and Business Updates
Initial Phase 1b monotherapy data for ERAS-007 in HERKULES-1 and first-in-human Phase 1 monotherapy data for ERAS-601 in FLAGSHP-1 expected in H2 2022
IND filing for CNS-penetrant KRAS G12C inhibitor ERAS-3490 in KRAS G12C mutant NSCLC in H2 2022
Bolstered clinical, operational, and commercial leadership
Strong balance sheet with cash, cash equivalents, and marketable securities of
“We continued to advance our development-stage programs this quarter, while also establishing a strong clinical foundation for their future expansion. We also were excited to enter two new clinical partnerships that broaden the clinical potential of ERAS-007 and ERAS-601 and complement our ongoing HERKULES and FLAGSHP-1 trials, respectively,” said
Research and Development (R&D) Highlights
- Presented Six Poster Presentations at the 2022 AACR Annual Meeting: In
April 2022 ,Erasca presented six poster presentations supporting the clinical development of programs with best-in-class potential, including ERK1/2 inhibitor ERAS-007,SHP2 inhibitor ERAS-601, and CNS-penetrant KRAS G12C inhibitor ERAS-3490, at theAmerican Association for Cancer Research (AACR) 2022 annual meeting - Hosted a Key Opinion Leader (KOL) Investor Webinar on AACR Data: In
April 2022 ,Erasca hosted an investor webinar highlighting its 2022 AACR presentations and featuring a presentation by KOL Scott Kopetz, M.D., Ph.D., ofMD Anderson Cancer Center - Announced Clinical Trial for ERAS-007 and KRAS G12C Inhibitor Combination: In
June 2022 ,Erasca announced a Phase 1b clinical proof-of-concept trial to evaluate the ERK1/2 inhibitor ERAS-007 in combination with a KRAS G12C inhibitor in KRAS G12C-driven NSCLC and CRC in partnership withRyan Corcoran , M.D., Ph.D., atHarvard Medical School andScott Kopetz , M.D., Ph.D., atMD Anderson Cancer Center , which trial is being funded under a grant from SU2C
Corporate Highlights
- Expanded Board of Directors: In
April 2022 ,Erasca increased the size of its board of directors (the Board) by one director and appointedJean I. Liu , J.D., to the Board and the audit committee of the Board - Opened New Corporate Headquarters: In
April 2022 ,Erasca opened its new corporate headquarters inSan Diego, CA , to accommodate and unify its expanded employee base - Strengthened Clinical, Operational, and Commercial Leadership: In
May 2022 ,Erasca appointedShannon Morris , M.D., Ph.D., as senior vice president of clinical development,Amy Grekowicz Parker as vice president of clinical operations, andJohn Lo , Ph.D., as senior commercial advisor and member of Erasca’s newly expanded Research, Development, andCommercial Advisory Board . InAugust 2022 ,Erasca appointedTim Grammer , Ph.D., as vice president of portfolio, program, and alliance management (PPAM).Dr. Grammer brings 20 years of project and program management, portfolio prioritization and planning, and alliance management experience in the life sciences. Most recently, as vice president of program management at Nektar Therapeutics,Dr. Grammer served as global program management lead for the bempegaldesleukin (NKTR-214) program for multiple solid tumors. He holds a Ph.D. in biochemistry fromHarvard University , an M.S. in medicine from Harvard, an MBA from theWharton School at theUniversity of Pennsylvania , and a B.S. in biochemistry from theUniversity of Illinois . He is a certified project management professional (PMP) - Entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with Eli Lilly (
Lilly ): InJuly 2022 ,Erasca announced that it had entered into a CTCSA under whichLilly will supply its EGFR inhibitor cetuximab (ERBITUX®) at no cost in connection with a clinical proof-of-concept trial evaluating ERAS-601, an oralSHP2 inhibitor, in various combinations including with cetuximab for the treatment of triple wildtype (KRAS/NRAS/BRAF wildtype) metastatic CRC and human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC) as part of the ongoing Phase 1/1b FLAGSHP-1 trial. This CTCSA complements the CTCSA we previously entered into withLilly 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
Key Upcoming Milestones
- HERKULES-1: Phase 1b/2 trial for ERAS-007/MAPKlamp in patients with advanced solid tumors
- Initial Phase 1b monotherapy data expected in the second half of 2022
- HERKULES-3: Phase 1b/2 trial for ERAS-007 in patients with gastrointestinal (GI) malignancies
- Initial Phase 1b combination data expected in 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 the second half of 2022
- Initial Phase 1b combination data in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC expected 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 expected in 2023
- ERAS-3490: CNS-penetrant KRAS G12C inhibitor
- IND filing expected in the second half of 2022
- IND filing expected in the second half of 2022
Second Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were
Research and Development Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss was
About
At
Cautionary Note Regarding Forward-Looking Statements
Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
2022 | 2021 | ||||||
Balance Sheet Data: | |||||||
Cash, cash equivalents, and marketable securities | $ | 390,789 | $ | 459,245 | |||
Working capital | 359,102 | 393,636 | |||||
Total assets | 444,823 | 501,415 | |||||
Accumulated deficit | (310,232 | ) | (238,166 | ) | |||
Total stockholders’ equity | 395,067 | 456,528 | |||||
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
Three months ended |
Six months ended |
|||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 27,488 | $ | 17,598 | $ | 54,917 | $ | 29,843 | ||||||||
In-process research and development | — | 5,488 | 2,000 | 9,168 | ||||||||||||
General and administrative | 8,417 | 5,098 | 15,493 | 8,780 | ||||||||||||
Total operating expenses | 35,905 | 28,184 | 72,410 | 47,791 | ||||||||||||
Loss from operations | (35,905 | ) | (28,184 | ) | (72,410 | ) | (47,791 | ) | ||||||||
Other income (expense) | ||||||||||||||||
Interest income | 388 | 31 | 502 | 61 | ||||||||||||
Other expense | (91 | ) | (61 | ) | (158 | ) | (116 | ) | ||||||||
Change in fair value of preferred stock purchase right liability | — | — | — | 1,615 | ||||||||||||
Total other income (expense), net | 297 | (30 | ) | 344 | 1,560 | |||||||||||
Net loss | $ | (35,608 | ) | $ | (28,214 | ) | $ | (72,066 | ) | $ | (46,231 | ) | ||||
Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (1.20 | ) | $ | (0.60 | ) | $ | (2.02 | ) | ||||
Weighted-average shares of common stock used in computing net loss per share, basic and diluted | 120,193,973 | 23,546,390 | 119,844,633 | 22,893,533 | ||||||||||||
Other comprehensive income (loss): | ||||||||||||||||
Unrealized loss on marketable securities, net | (272 | ) | (2 | ) | (1,061 | ) | (3 | ) | ||||||||
Comprehensive loss | $ | (35,880 | ) | $ | (28,216 | ) | $ | (73,127 | ) | $ | (46,234 | ) |
ERBITUX® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
BRAFTOVI® is a registered trademark owned by or licensed to Pfizer Inc., its subsidiaries, or affiliates.
Contact:
jallaire@lifesciadvisors.com
Source:
Source: Erasca, Inc.