Erasca Reports Third Quarter 2024 Business Updates and Financial Results
Erasca (ERAS) reported Q3 2024 financial results and business updates, highlighting positive preliminary Phase 1b data in SEACRAFT-1 NRASm melanoma cohort. The company maintains a strong financial position with $463.3 million in cash and equivalents as of September 30, 2024, expected to fund operations into H1 2027. Q3 net loss was $31.2 million ($0.11 per share). R&D expenses increased to $27.6 million, while G&A expenses were $9.6 million. The company is advancing its RAS targeting franchise with planned IND submissions for ERAS-4001 in Q1 2025 and ERAS-0015 in H1 2025.
Erasca (ERAS) ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti aziendali, evidenziando dati preliminari positivi della Fase 1b nel cohort di melanoma NRASm dello studio SEACRAFT-1. L'azienda mantiene una posizione finanziaria solida con $463.3 milioni in liquidità e equivalenti al 30 settembre 2024, previsti per finanziare le operazioni fino alla prima metà del 2027. La perdita netta nel terzo trimestre è stata di $31.2 milioni ($0.11 per azione). Le spese per ricerca e sviluppo sono aumentate a $27.6 milioni, mentre le spese generali e amministrative sono state di $9.6 milioni. L'azienda sta avanzando il suo franchise di targetizzazione RAS con le submission IND pianificate per ERAS-4001 nel primo trimestre del 2025 e ERAS-0015 nella prima metà del 2025.
Erasca (ERAS) informó los resultados financieros del tercer trimestre de 2024 y actualizaciones comerciales, destacando datos preliminares positivos de la Fase 1b en el cohort de melanoma NRASm del estudio SEACRAFT-1. La compañía mantiene una sólida posición financiera con $463.3 millones en efectivo y equivalentes al 30 de septiembre de 2024, que se espera financien las operaciones hasta la primera mitad de 2027. La pérdida neta del tercer trimestre fue de $31.2 millones ($0.11 por acción). Los gastos de I+D aumentaron a $27.6 millones, mientras que los gastos generales y administrativos fueron de $9.6 millones. La empresa está avanzando en su franquicia de enfoque en RAS con presentaciones IND planificadas para ERAS-4001 en el primer trimestre de 2025 y ERAS-0015 en la primera mitad de 2025.
Erasca (ERAS)는 2024년 3분기 재무 결과 및 사업 업데이트를 보고하며, SEACRAFT-1 NRASm 흑색종 코호트에서 긍정적인 초기 1b 단계 데이터를 강조했습니다. 이 회사는 2024년 9월 30일 기준으로 $463.3 백만의 현금 및 현금성 자산을 보유하고 있으며, 이는 2027년 상반기까지 운영 자금을 지원할 것으로 예상됩니다. 3분기 순손실은 $31.2 백만 ($0.11 주당)으로 보고되었습니다. 연구 개발 비용은 $27.6 백만으로 증가했으며, 일반 및 관리 비용은 $9.6 백만이었습니다. 이 회사는 2025년 1분기에 ERAS-4001에 대한 IND 제출 및 2025년 상반기에 ERAS-0015에 대한 계획을 세우며 RAS 타겟팅 프랜차이즈를 진행하고 있습니다.
Erasca (ERAS) a rapporté les résultats financiers du 3ème trimestre 2024 et des mises à jour commerciales, mettant en avant des données préliminaires positives de la phase 1b dans la cohorte de mélanome NRASm de l'étude SEACRAFT-1. L'entreprise maintient une solide position financière avec $463.3 millions en liquidités et équivalents au 30 septembre 2024, ce qui devrait financer ses opérations jusqu'au premier semestre 2027. La perte nette au 3ème trimestre était de $31.2 millions ($0.11 par action). Les dépenses de R&D ont augmenté à $27.6 millions, tandis que les dépenses générales et administratives étaient de $9.6 millions. L'entreprise fait progresser sa franchise de ciblage RAS avec des soumissions IND prévues pour ERAS-4001 au 1er trimestre 2025 et ERAS-0015 dans la première moitié de 2025.
Erasca (ERAS) hat die finanziellen Ergebnisse für das 3. Quartal 2024 und Unternehmensaktualisierungen veröffentlicht und dabei positive vorläufige Phase 1b-Daten zur NRASm-Melanom-Gruppe im SEACRAFT-1-Studie hervorgehoben. Das Unternehmen hat eine starke finanzielle Position mit $463.3 Millionen an Barmitteln und Äquivalenten zum 30. September 2024, die voraussichtlich die Geschäftstätigkeit bis in die erste Jahreshälfte 2027 finanzieren werden. Der Nettverlust im 3. Quartal betrug $31.2 Millionen ($0.11 pro Aktie). Die F&E-Ausgaben stiegen auf $27.6 Millionen, während die allgemeinen und administrativen Ausgaben bei $9.6 Millionen lagen. Das Unternehmen treibt seine RAS-Targeting-Franchise mit geplanten IND-Einreichungen für ERAS-4001 im 1. Quartal 2025 und ERAS-0015 in der ersten Hälfte von 2025 voran.
- Strong cash position of $463.3 million, providing runway into H1 2027
- Positive preliminary Phase 1b data in SEACRAFT-1 NRASm melanoma cohort
- Reduced net loss per share from $0.20 to $0.11 year-over-year
- Increased R&D expenses to $27.6 million from $25.2 million year-over-year
- Net loss increased to $31.2 million from $30.4 million year-over-year
Insights
The Q3 2024 results reveal a strong financial position with
The company's pipeline progress, particularly with SEACRAFT-2's potential regulatory pathway and upcoming IND submissions for ERAS-0015 and ERAS-4001, presents multiple value-driving catalysts through 2025-2026. The robust cash position adequately supports these development programs without immediate financing needs.
The preliminary Phase 1b SEACRAFT-1 data in NRAS-mutant melanoma demonstrates promising clinical progress, strategically positioning the SEACRAFT-2 registrational trial. The focus on NRASm melanoma, an area of high unmet need with regulatory alignment, increases probability of success. The dual advancement of pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 represents a comprehensive approach to RAS/MAPK pathway targeting.
The potential best-in-class profiles for both agents, if confirmed in clinical trials, could establish Erasca as a leader in precision oncology for RAS-driven cancers. The planned IND submissions in early 2025 and subsequent clinical data readouts in 2026 create a well-structured development timeline with multiple opportunities for value creation.
Positive preliminary Phase 1b data in SEACRAFT-1 NRASm melanoma cohort bolsters conviction in ongoing SEACRAFT-2 registrational trial; Stage 1 randomized data expected in 2025
Strong execution across potentially best-in-class RAS targeting franchise; planned IND submissions on track
Robust balance sheet with cash, cash equivalents, and marketable securities of
SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- 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, today provided business updates and reported financial results for the fiscal quarter ended September 30, 2024.
“We made significant progress across our pipeline programs and are pleased with the pace of our execution. Positive preliminary data from SEACRAFT-1, which we reported at the 36th EORTC-NCI-AACR (ENA) Symposium last month, has refined our clinical development focus of naporafenib plus trametinib on patients with NRAS-mutant (NRASm) melanoma, and importantly, heightens our conviction in the ongoing SEACRAFT-2 registrational trial targeting a similar patient population,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “SEACRAFT-2 has the potential for approval based on the high unmet need of these patients as well as the alignment with US and European regulators on the NRASm melanoma indication. We expect randomized dose optimization data from Stage 1 of this Phase 3 trial in 2025.”
Dr. Lim added, “Our RAS targeting franchise, which includes a potential best-in-class pan-RAS molecular glue ERAS-0015 and a potential first-in-class pan-KRAS inhibitor ERAS-4001, holds significant promise to help a broad range of patients with RAS-mutant (RASm) solid tumors. Following the in-licensing of these molecules in May, we have rapidly and effectively confirmed in-house the potential best-in-class profiles of both agents and executed across multiple activities to support their planned investigational new drug (IND) application submissions, which remain on track for the first quarter of 2025 for ERAS-4001 and the first half of 2025 for ERAS-0015. We continue to be well capitalized with an anticipated cash runway into the first half of 2027 and are poised for strong execution across our pipeline.”
Research and Development (R&D) Highlights
- Presented Promising SEACRAFT-1 Phase 1 Data: In October 2024, Erasca presented Phase 1b SEACRAFT-1 data for naporafenib plus trametinib (MEKINIST®) in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations at the 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics and as part of a company R&D update. Data support rationale for pursuing an NRASm melanoma indication and reinforces the potential of the ongoing Phase 3 SEACRAFT-2 registrational trial.
- Announced Progress Across RAS Targeting Franchise: In October 2024, Erasca presented a program update for pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 as part of a company R&D update, highlighting the rapid progress across both programs including in-house confirmation of potential best-in-class profiles for both agents and advancement of activities to support planned IND application submissions.
Key Upcoming Milestones
- SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
- Phase 3 Stage 1 randomized dose optimization data expected to be reported in 2025
- AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors
- IND filing expected in H1 2025
- Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026
- BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors
- IND filing expected in Q1 2025
- Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026
Third Quarter 2024 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
About Erasca
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipelines in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.
Cautionary Note Regarding Forward-Looking Statements
Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates, including naporafenib, ERAS-0015, and ERAS-4001; the planned advancement of our development pipeline, including the anticipated timing of data readouts for the SEACRAFT-2, AURORAS-1, and BOREALIS-1 trials; our alignment with regulatory authorities on the regulatory pathway for naporafenib; the anticipated timing of the IND filings for the AURORAS-1 and BOREALIS-1 trials; our ability to successfully prioritize our pipeline portfolio to focus on existing programs that we believe have the highest probability of success; and the sufficiency of our cash, cash equivalents, and marketable securities to fund operations into the first half of 2027. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; results from preclinical studies or early clinical trials not necessarily being predictive of future results; preliminary results of clinical trials are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and more patient data become available; our planned SEACRAFT trials may not support the registration of naporafenib; our assumptions about ERAS-0015’s or ERAS-4001’s development potential are based in large part on the preclinical data generated by the licensors and we may observe materially and adversely different results as we conduct our planned studies and trials; we only have one product candidate in clinical development and all of our other development efforts are in the preclinical or development stage; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, data readout, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; the inability to realize any benefits from our current licenses, acquisitions, and collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; later developments with the FDA or EU health authorities may be inconsistent with the feedback received to date regarding our development plans and trial designs; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; we may use our capital resources sooner than we expect; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
| Erasca, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Balance Sheet Data: | ||||||||
| Cash, cash equivalents, and marketable securities | $ | 463,303 | $ | 321,992 | ||||
| Working capital | 300,149 | 294,520 | ||||||
| Total assets | 528,896 | 395,297 | ||||||
| Accumulated deficit | (735,431 | ) | (606,013 | ) | ||||
| Total stockholders’ equity | 450,042 | 316,686 | ||||||
| Erasca, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 27,631 | $ | 25,213 | $ | 89,237 | $ | 79,016 | ||||||||
| In-process research and development | — | — | 22,500 | — | ||||||||||||
| General and administrative | 9,611 | 9,445 | 32,138 | 28,637 | ||||||||||||
| Total operating expenses | 37,242 | 34,658 | 143,875 | 107,653 | ||||||||||||
| Loss from operations | (37,242 | ) | (34,658 | ) | (143,875 | ) | (107,653 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 5,869 | 4,346 | 14,810 | 12,474 | ||||||||||||
| Other income (expense), net | 173 | (49 | ) | (353 | ) | (162 | ) | |||||||||
| Total other income (expense), net | 6,042 | 4,297 | 14,457 | 12,312 | ||||||||||||
| Net loss | $ | (31,200 | ) | $ | (30,361 | ) | $ | (129,418 | ) | $ | (95,341 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.20 | ) | $ | (0.60 | ) | $ | (0.64 | ) | ||||
| Weighted-average shares of common stock used in computing net loss per share, basic and diluted | 282,384,964 | 150,450,201 | 217,355,959 | 150,000,613 | ||||||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain on marketable securities, net | 2,021 | 218 | 1,748 | 466 | ||||||||||||
| Comprehensive loss | $ | (29,179 | ) | $ | (30,143 | ) | $ | (127,670 | ) | $ | (94,875 | ) | ||||
MEKINIST® is a registered trademark owned by or licensed to Novartis AG, its subsidiaries, or affiliates.
Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
Source: Erasca, Inc.
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