WASHINGTON, DC 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ______________ Commission File Number: 001-40602 ERASCA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-1217027 (State ...

Erasca Reports First Quarter 2025 Business Updates and Financial Results Early entry of RAS-targeting franchise into clinic enabled by strong execution Initial Phase 1 monotherapy data for pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 expected in 2026 Robust balance sheet with cash, cash equivalents, and marketable securities of $411 million as of March 31, 2025 with cash runway guidance extended to H2 2028 SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinic ...

Early entry of RAS-targeting franchise into clinic enabled by strong execution Initial Phase 1 monotherapy data for pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 expected in 2026 Robust balance sheet with cash, cash equivalents, and marketable securities of $411 million as of March 31, 2025 with cash runway guidance extended to H2 2028 SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, de ...

SAN DIEGO, May 07, 2025 (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 announced its participation in the Bank of America Securities 2025 Health Care Conference being held at the Encore Hotel in Las Vegas, Nevada. Management will present on Wednesday, May 14, 2025, at 2:35 pm Pacific Time and will also participate in one-on-one in ...

ERAS-0015 and ERAS-4001 showed robust anti-tumor activity as monotherapy and combination therapy First-in-class examples of direct SHOC2 binders and modulators of SMP complex assembly identified with potential to block oncogenic RAS/MAPK pathway signaling SAN DIEGO, April 29, 2025 (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 pre ...

Erasca, Inc. ( ERAS ) is a developmental biotech operating almost entirely in the space of developing novel targeted therapies against the RAS/MAP kinase pathway in solid tumor oncology. Having fallen over 50% sinceI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls o ...

Presentations will feature potential best-in-class pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 Erasca will also present potential first-in-class examples of direct SMP complex inhibitors, representing a new approach to block the RAS/MAPK pathway SAN DIEGO, March 25, 2025 (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 ...

Financial Performance - The company has incurred significant operating losses of $161.7 million and $125.0 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $767.7 million as of December 31, 2024[295]. - The company has not generated any revenue since its inception in 2018 and does not have any products approved for sale[295]. - The company expects to continue incurring significant losses for the foreseeable future, with anticipated increases in expenses related to ongoing clinical trials and regulatory approvals[295]. - The company believes its existing cash, cash equivalents, and marketable securities will fund operations into the second half of 2027, but may need additional capital sooner than planned[299]. - The company has entered into an Open Market Sale Agreement allowing for the sale of up to $200 million in common stock, with $21.9 million sold as of December 31, 2024[299]. - The company has incurred substantial losses and does not expect to achieve profitability in the near future, which may limit the use of its NOL carryforwards[429]. Clinical Development and Regulatory Challenges - The ongoing SEACRAFT-2 Phase 3 clinical trial for naporafenib is the only advanced program, while other product candidates remain in preclinical or discovery stages[294]. - The company may face challenges in obtaining regulatory approvals and successfully commercializing its product candidates, which could materially harm its business[306]. - Clinical and preclinical development is lengthy and expensive, with a high historical failure rate for product candidates in the industry[312]. - The company may face delays in clinical trials due to various factors, including regulatory approvals, patient enrollment challenges, and trial protocol deviations[316]. - Any safety concerns observed in clinical trials could limit the prospects for regulatory approval of the company's product candidates, adversely affecting its business and financial condition[314]. - The company must conduct extensive clinical studies to demonstrate the safety, purity, potency, and efficacy of its product candidates before obtaining marketing approval[315]. - The regulatory approval processes are lengthy and unpredictable, with a small percentage of drugs successfully completing the FDA approval process[332]. - The company plans to conduct multiple clinical trials for various product candidates in parallel, which may strain its limited resources and management focus[336]. - The company may need to conduct additional clinical trials or studies post-approval, which could delay commercialization[335]. - The company is conducting clinical trials outside the United States, which may face acceptance issues from the FDA, potentially delaying development plans and harming the business[342]. Intellectual Property and Patent Risks - The company’s success is heavily dependent on obtaining and maintaining patent protection for its product candidates, which is complex and costly[435]. - The patent prosecution process is time-consuming, and failure to identify patentable aspects could jeopardize the company's ability to protect its innovations[437]. - The company may face challenges in enforcing its intellectual property rights in foreign jurisdictions, which could diminish its competitive position[444]. - The company may face claims challenging the inventorship of its patents, which could result in loss of valuable intellectual property rights[461]. - The company partially depends on intellectual property licensed from third parties, and failure to comply with obligations could result in loss of significant rights[478]. - The company does not have complete control over the maintenance and prosecution of its in-licensed patents, which could affect commercialization efforts[479]. Market and Competitive Landscape - The commercial success of product candidates will depend on market acceptance among physicians, patients, and healthcare payors, influenced by clinical efficacy and safety[379]. - The company faces competition for access to manufacturing facilities, particularly due to the high potency of its product candidates[367]. - Competition in the oncology sector is intense, with numerous companies developing therapies targeting similar indications, which may affect the commercial potential of the company's products[388]. - The company faces significant competition for qualified personnel, which may impede its ability to achieve development objectives and implement its business strategy[402]. - The company currently lacks a marketing and sales organization and may need to invest significant resources to develop these capabilities for product commercialization[395]. Financial and Operational Risks - The company may need to rely on additional financing to achieve its business objectives, which could lead to dilution of stockholder interests[303]. - The company may face significant negative consequences if undesirable side effects are identified post-approval, impacting market acceptance[326]. - The company may incur substantial liabilities from product liability lawsuits, which could limit the commercialization of its products[413]. - The unpredictability of operating results makes it difficult for the company to meet analysts' expectations, potentially leading to a decline in stock price[400]. - The company may face significant uninsured liabilities due to the high costs and limitations of its insurance policies, which could adversely affect its financial position[416]. Compliance and Regulatory Environment - The company is subject to various healthcare laws and regulations that could increase compliance costs and expose it to significant penalties if violated[404]. - The company is subject to regulatory reporting obligations regarding adverse medical events, with potential sanctions for non-compliance that could materially harm its business[417]. - Compliance with Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) regulations is essential; non-compliance may require repeating clinical trials[361]. - The company may engage in strategic transactions, such as acquisitions or partnerships, which could impact liquidity and increase expenses[428]. Data Privacy and Cybersecurity - Cybersecurity risks pose a threat to the company's information technology systems, which could result in material disruptions and significant financial penalties[418]. - The company is subject to various federal and state data privacy laws, including HIPAA and the California Consumer Privacy Act (CCPA), which may impose additional compliance burdens[489]. - Evolving legal obligations regarding data privacy and cybersecurity may create inconsistencies and conflicts, potentially leading to increased liability and reputational damage[492].

Financial Position - Erasca reported cash, cash equivalents, and marketable securities of $440.5 million as of December 31, 2024, up from $322.0 million as of December 31, 2023, indicating a strong financial position[9]. - The total assets of Erasca increased to $502.5 million as of December 31, 2024, from $395.3 million as of December 31, 2023[19]. - The accumulated deficit as of December 31, 2024, was $767.7 million, compared to $606.0 million as of December 31, 2023[19]. - The company raised $251 million in equity financing in 2024, extending its cash runway into the second half of 2027[7]. Research and Development - Research and Development (R&D) expenses for Q4 2024 were $26.1 million, compared to $24.8 million in Q4 2023, with full-year R&D expenses totaling $115.4 million, up from $103.8 million in 2023[10]. - The SEACRAFT-2 trial is progressing well, with Stage 1 randomized data expected in H2 2025, and the FDA granted Fast Track Designation for the trial in NRASm melanoma[2]. - Erasca expects to submit investigational new drug (IND) applications for ERAS-0015 in mid-Q2 2025 and for ERAS-4001 in Q2 2025, with initial Phase 1 data expected in 2026[2][8]. - The pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 are expected to address unmet medical needs in approximately 2.7 million patients diagnosed annually with RAS-mutant tumors[4]. Operating Expenses - General and Administrative (G&A) expenses for Q4 2024 were $9.6 million, compared to $9.1 million in Q4 2023, with full-year G&A expenses totaling $41.7 million, up from $37.7 million in 2023[13]. - Total operating expenses for the year ended December 31, 2024, were $179,587 million, compared to $141,525 million in 2023, reflecting a year-over-year increase of 26.9%[21]. - General and administrative expenses for the year ended December 31, 2024, were $41,728 million, compared to $37,704 million in 2023, marking an increase of 10.7%[21]. - In-process research and development expenses for the year ended December 31, 2024, were $22,500 million, with no expenses reported in 2023[21]. Net Loss and Income - The net loss for Q4 2024 was $32.2 million, compared to a net loss of $29.7 million in Q4 2023, while the full-year net loss was $161.7 million, or $(0.69) per share, compared to a net loss of $125.0 million, or $(0.83) per share, in 2023[14]. - The net loss for Q4 2024 was $32,232 million, compared to a net loss of $29,701 million in Q4 2023, indicating an increase in losses of 8.5%[21]. - The net loss per share for the year ended December 31, 2024, was $0.69, down from $0.83 in 2023, showing an improvement of 16.9%[21]. - Comprehensive loss for the year ended December 31, 2024, was $161,322 million, compared to $123,924 million in 2023, reflecting an increase of 30.2%[21]. - Interest income for the year ended December 31, 2024, was $20,093 million, an increase from $16,712 million in 2023, representing a growth of 20.5%[21]. Share Information - The weighted-average shares used in computing net loss per share, basic and diluted, increased to 282,845,918 in Q4 2024 from 150,732,123 in Q4 2023[21]. - Total other income (expense), net for Q4 2024 was $3,480 million, down from $4,170 million in Q4 2023, indicating a decrease of 16.5%[21].

Core Insights - Erasca, Inc. is advancing its RAS-targeting franchise with two promising candidates, ERAS-0015 and ERAS-4001, expected to enter clinical trials in 2025 [1][2] - The ongoing Phase 3 SEACRAFT-2 trial is progressing well, with randomized data anticipated in the second half of 2025 [1][2] - The company has a robust financial position, with cash, cash equivalents, and marketable securities totaling $440 million as of December 31, 2024, which is expected to fund operations into the second half of 2027 [1][9][10] RAS-Targeting Franchise - The RAS-targeting franchise includes ERAS-0015, a potential best-in-class pan-RAS molecular glue, and ERAS-4001, a potential first-in-class pan-KRAS inhibitor, both addressing significant unmet medical needs in various cancers [2][5] - The SEACRAFT-2 trial has received FDA Fast Track Designation for NRASm melanoma, positioning it as a potential first-to-market therapy in a high unmet need area [2][5] Research and Development Highlights - The company has made significant progress in its RAS-targeting programs, with key activities completed to support IND submissions for both ERAS-0015 and ERAS-4001 [5] - Initial Phase 1b data for naporafenib plus trametinib in melanoma showed promising efficacy and tolerability, reinforcing the rationale for the ongoing SEACRAFT-2 trial [5][6] Financial Performance - R&D expenses for Q4 2024 were $26.1 million, up from $24.8 million in Q4 2023, driven by clinical trial and preclinical study costs [11] - For the full year 2024, R&D expenses totaled $115.4 million, compared to $103.8 million in 2023 [11] - The net loss for Q4 2024 was $32.2 million, compared to $29.7 million in Q4 2023, with a full-year net loss of $161.7 million, or $(0.69) per share [13][20] Corporate Developments - The company strengthened its leadership team with key appointments in medical affairs and clinical development, enhancing its capabilities in oncology [10] - Upcoming milestones include IND filings for ERAS-0015 and ERAS-4001 in mid-Q2 and Q2 2025, respectively, with initial Phase 1 data expected in 2026 [10][8]