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]

Company Overview - Erasca, Inc. is a clinical-stage precision oncology company focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers [3] - The company was co-founded by pioneers in precision oncology and RAS targeting, aiming to create novel therapies and combination regimens to comprehensively shut down the RAS/MAPK pathway [3] - Erasca has one of the deepest RAS/MAPK pathway-focused pipelines in the industry, supported by a scientific advisory board of leading experts [3] Recent Events - Erasca announced its participation in the Guggenheim Securities SMID Cap Biotech Conference on February 6, 2025, at 9:30 am Eastern Time, where management will engage in a fireside chat and one-on-one investor meetings [1] - A live audio webcast of the event will be available on Erasca's website, with an archived replay accessible for 30 days post-event [2]

Group 1 - Erasca is a precision oncology company focusing on therapies targeting specific cancer-related mutations, particularly through the RAS/MAPK pathways [1] - The company has a relatively late-stage pipeline with its main drug candidate, Naporafenib [1]

Core Viewpoint - Erasca, Inc. (ERAS) has experienced significant selling pressure, resulting in a 25.4% decline in stock price over the past four weeks, but analysts anticipate improved earnings reports in the near future [1] Group 1: Stock Performance and Technical Indicators - The stock is currently in oversold territory, indicated by an RSI reading of 22.16, suggesting a potential trend reversal [5] - The Relative Strength Index (RSI) is a momentum oscillator that helps identify oversold conditions when the reading falls below 30 [2][3] Group 2: Earnings Estimates and Analyst Sentiment - There has been a consensus among sell-side analysts to raise earnings estimates for ERAS, resulting in a 1% increase in the consensus EPS estimate over the last 30 days [6] - ERAS holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating strong potential for a turnaround [7]

Core Viewpoint - Erasca, Inc. (ERAS) has experienced significant selling pressure, resulting in a 27.2% decline over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is utilized to identify oversold stocks, with a reading below 30 indicating oversold conditions [2] - ERAS has an RSI reading of 20.75, suggesting that the heavy selling may be exhausting, indicating a potential rebound [5] Group 2: Fundamental Indicators - Analysts have raised earnings estimates for ERAS by 1% over the last 30 days, which typically correlates with price appreciation [6] - ERAS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, indicating a strong potential for a turnaround [7]

Core Viewpoint - Erasca, Inc. (ERAS) is experiencing significant selling pressure, having declined 24.1% over the past four weeks, but is now positioned for a potential trend reversal as it is in oversold territory and analysts expect better earnings than previously predicted [1] Group 1: Stock Performance and Technical Indicators - The stock's Relative Strength Index (RSI) reading is at 20.63, indicating it is oversold and suggesting a potential reversal in trend [5] - A stock is generally considered oversold when its RSI falls below 30, which helps investors identify entry opportunities for potential rebounds [2][3] Group 2: Earnings Estimates and Analyst Consensus - There is strong agreement among sell-side analysts in raising earnings estimates for ERAS, with a 1% increase in the consensus EPS estimate over the last 30 days [6] - An upward trend in earnings estimate revisions typically correlates with price appreciation in the near term [6] Group 3: Zacks Rank and Investment Potential - ERAS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [7]

Core Viewpoint - Erasca, Inc. (ERAS) is experiencing significant selling pressure, with a 22.9% decline over the past four weeks, but is now positioned for a potential trend reversal as it enters oversold territory, supported by analyst expectations of better earnings than previously predicted [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - ERAS has an RSI reading of 21.15, suggesting that heavy selling may be exhausting, indicating a potential bounce back towards equilibrium in supply and demand [5] Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that earnings estimates for ERAS will improve, with a 1% increase in the consensus EPS estimate over the last 30 days, which often correlates with price appreciation [6] - ERAS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a near-term turnaround [7]