Erasca(ERAS)
Search documents
Erasca Announces $45 Million Oversubscribed Private Placement Financing
Newsfilter· 2024-03-28 00:30
SAN DIEGO, March 27, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (NASDAQ:ERAS) ("Erasca"), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced that it has entered into a securities purchase agreement with a select group of institutional accredited investors to sell 21,844,660 shares of its common stock in an oversubscribed private placement at a price of $2.06 per share. Erasca a ...
Erasca(ERAS) - 2023 Q4 - Annual Report
2024-03-27 20:15
Financial Performance - The company incurred net losses of $125.0 million and $242.8 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $606.0 million as of December 31, 2023[320]. - The company has not generated any revenue since its inception in 2018 and does not have any products approved for sale[320]. - The company expects to continue incurring significant losses for the foreseeable future as it develops its product candidates and seeks regulatory approvals[320]. - The company believes its existing cash, cash equivalents, and marketable securities will fund operations into the first half of 2026, but may need additional capital sooner than planned[324]. - The company has entered into an Open Market Sale Agreement allowing it to sell up to $200 million of its common stock, but there is no assurance of successful sales[324]. Product Development and Clinical Trials - The company is in early clinical development stages for its product candidates ERAS-007 and ERAS-801, and has not yet completed any clinical trials for naporafenib[331]. - The company’s scientific approach focuses on shutting down the RAS/MAPK pathway, which is unproven and may limit the commercial value of its product candidates[333]. - Clinical and preclinical development is lengthy and expensive, with a high historical failure rate for product candidates in the industry, which may lead to significant delays or abandonment of development efforts[337]. - The company may face difficulties in enrolling patients for clinical trials, which could delay or adversely affect clinical development activities[347]. - The company plans to conduct multiple clinical trials for various product candidates in parallel over the next several years, which may strain limited resources[362]. Regulatory Challenges - The regulatory approval process for product candidates is lengthy and unpredictable, with a small percentage of drugs successfully completing the FDA approval process[360]. - The company has limited experience in preparing and submitting regulatory filings, which may hinder the approval process for product candidates[355]. - The company may face significant negative consequences if undesirable side effects are identified post-approval, potentially harming market acceptance and financial condition[354]. - The FDA granted Orphan Drug Designation (ODD) to ERAS-801 for the treatment of malignant glioma, including recurrent glioblastoma multiforme (GBM) in June 2023[364]. - The company may seek accelerated approval pathways for product candidates, but there is no guarantee that such applications will be accepted or granted in a timely manner[374]. Market and Competitive Landscape - The commercial success of the product candidates will depend on market acceptance by physicians, patients, and healthcare payors, with significant reliance on clinical efficacy and safety compared to established products[403][404]. - The company faces significant competition from other entities developing cancer therapies, which may affect its ability to commercialize products successfully[413][414]. - The market opportunities for product candidates may be limited to patients who are ineligible for or have failed prior treatments, potentially reducing the estimated market size[417][418]. - Third-party payors are increasingly challenging prices for biopharmaceutical products, which may limit the company's ability to charge competitive prices[407]. Intellectual Property Risks - The patent prosecution process is expensive and complex, and the company may not be able to maintain or enforce all necessary patent applications[463]. - The company may face reputational damage if it fails to meet investors' expectations regarding environmental, social, and governance factors[460]. - The company may face substantial risks related to third-party claims of intellectual property infringement, which could delay product development and commercialization[490]. - Legal proceedings related to intellectual property could substantially increase operating losses and reduce resources available for development and marketing activities[494]. Operational and Compliance Risks - The company is subject to various healthcare laws and regulations that could increase compliance costs and expose it to significant penalties if violated[430]. - The company must manage additional relationships with strategic partners and suppliers as it expands operations, which is critical for future financial performance[429]. - The company relies on third-party vendors for manufacturing, and disruptions in their systems could adversely affect business operations[446]. - The company is exposed to risks from employee misconduct or noncompliance with regulatory standards, which could lead to serious reputational harm[452]. Financial and Tax Considerations - As of December 31, 2023, the company has federal net operating loss (NOL) carryforwards of $200.9 million, California NOL carryforwards of $243.1 million, and other state NOL carryforwards of $2.5 million[455]. - The company has recorded a full valuation allowance related to its NOL carryforwards and other deferred tax assets due to uncertainty regarding the realization of future benefits[457]. - Changes in ownership could limit the company's ability to utilize its NOL carryforwards, potentially increasing future income tax liabilities[457]. Cybersecurity and Legal Risks - Cybersecurity risks are increasing, with potential breaches leading to significant disruptions in product development and harm to the company's reputation[444]. - The company is subject to various legal and regulatory risks, including potential litigation and government investigations that could result in fines and operational impacts[450]. - The company may incur significant costs related to cybersecurity incidents, including legal expenses and remediation efforts, impacting overall financial performance[446].
Erasca(ERAS) - 2023 Q4 - Annual Results
2024-03-27 20:05
Financial Performance - As of December 31, 2023, Erasca reported cash, cash equivalents, and marketable securities of $322 million, down from $436 million as of December 31, 2022[7]. - The net loss for Q4 2023 was $29.7 million, significantly improved from a net loss of $135.3 million in Q4 2022[11]. - Total stockholders' equity decreased to $316.7 million as of December 31, 2023, from $411.9 million in 2022[17]. - The accumulated deficit increased to $606 million as of December 31, 2023, compared to $481 million in 2022[17]. - Comprehensive loss for the year ended December 31, 2023, was $123,924,000, down from $243,684,000 in 2022, a reduction of about 49%[19]. Research and Development - Research and Development (R&D) expenses for Q4 2023 were $24.8 million, a decrease from $29.4 million in Q4 2022, primarily due to reduced clinical trial costs[7]. - For the full year 2023, R&D expenses totaled $103.8 million, down from $112.5 million in 2022, which included $102 million of in-process R&D expenses[9]. - Research and development expenses decreased to $24,805,000 in Q4 2023 from $29,356,000 in Q4 2022, a decline of about 15.5%[19]. - In-process research and development expenses were $100,000 in Q4 2022, with no expenses reported in Q4 2023[19]. Clinical Trials and Regulatory Updates - Erasca gained regulatory clarity for the pivotal Phase 3 SEACRAFT-2 trial for naporafenib, expected to initiate in the first half of 2024[3]. - Fast Track Designation was granted for naporafenib in combination with trametinib for treating NRAS-mutant melanoma patients[8]. - The company entered into two clinical trial collaboration agreements with Novartis for the SEACRAFT-1 and SEACRAFT-2 trials[8]. - The company achieved a median overall survival (mOS) of approximately 13-14 months for patients with NRAS-mutant melanoma treated with naporafenib plus trametinib, nearly doubling historical benchmarks[4]. Operating Expenses - Total operating expenses for Q4 2023 were $33,871,000, a decrease from $138,078,000 in Q4 2022, representing a reduction of approximately 75.5%[19]. - General and administrative expenses rose to $9,066,000 in Q4 2023 from $8,722,000 in Q4 2022, an increase of about 3.9%[19]. Other Financial Metrics - Interest income increased to $4,237,000 in Q4 2023 from $2,878,000 in Q4 2022, reflecting a growth of approximately 47.2%[19]. - Total other income (expense), net for Q4 2023 was $4,170,000, compared to $2,828,000 in Q4 2022, an increase of approximately 47.5%[19]. - Net loss per share, basic and diluted, improved to $0.20 in Q4 2023 from $1.06 in Q4 2022[19]. - Weighted-average shares used in computing net loss per share increased to 150,732,123 in Q4 2023 from 127,540,712 in Q4 2022[19].
Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials
Newsfilter· 2024-02-14 13:00
Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor in multiple RAS/MAPK pathway-driven tumors Initial SEACRAFT-1 Phase 1b combination data in RAS Q61X solid tumors expected between Q2-Q4 2024 Initiation of pivotal SEACRAFT-2 in NRASm melanoma expected in H1 2024 SAN DIEGO, Feb. 14, 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 ...
Erasca(ERAS) - 2023 Q3 - Quarterly Report
2023-11-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 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 September 30, 2023 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) (State or other jurisd ...
Erasca(ERAS) - 2023 Q2 - Quarterly Report
2023-08-09 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for H1 2023 show total assets decreased to $440.7 million, a net loss of $65.0 million (improved from $72.1 million), and stable operating cash usage [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to $440.7 million from $514.9 million, driven by reduced cash, with liabilities and equity also declining Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $138,787 | $284,217 | | Total current assets | $323,851 | $444,496 | | **Total assets** | **$440,662** | **$514,909** | | **Liabilities & Equity** | | | | Total current liabilities | $23,292 | $48,690 | | **Total liabilities** | **$77,957** | **$103,056** | | Accumulated deficit | ($545,951) | ($480,971) | | **Total stockholders' equity** | **$362,705** | **$411,853** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For H1 2023, net loss improved to $65.0 million from $72.1 million in H1 2022, primarily due to a significant increase in interest income Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $26,218 | $27,488 | $53,803 | $54,917 | | General and administrative | $9,752 | $8,417 | $19,192 | $15,493 | | Loss from operations | ($35,970) | ($35,905) | ($72,995) | ($72,410) | | Interest income | $4,251 | $388 | $8,128 | $502 | | **Net loss** | **($31,781)** | **($35,608)** | **($64,980)** | **($72,066)** | | Net loss per share | ($0.21) | ($0.30) | ($0.43) | ($0.60) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased from $411.9 million to $362.7 million in H1 2023, primarily due to net loss, partially offset by stock-based compensation Changes in Stockholders' Equity (H1 2023, in thousands) | Description | Amount | | :--- | :--- | | Balance at December 31, 2022 | $411,853 | | Net loss | ($64,980) | | Stock-based compensation expense | $13,857 | | Exercise of stock options & ESPP | $832 | | Other changes | ($8,857) | | **Balance at June 30, 2023** | **$362,705** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $52.3 million for H1 2023, while investing activities used $94.0 million, resulting in a $145.4 million net decrease in cash Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($52,309) | ($52,947) | | Net cash used in investing activities | ($93,953) | ($10,985) | | Net cash provided by financing activities | $832 | $1,452 | | **Net decrease in cash, cash equivalents and restricted cash** | **($145,430)** | **($62,480)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's oncology focus, sufficient cash runway into 2024, significant future milestone obligations, and the UCSF license termination - The company is a clinical-stage precision oncology company focused on discovering and developing therapies for RAS/MAPK pathway-driven cancers[18](index=18&type=chunk) - Management believes its cash, cash equivalents, and short-term marketable securities of **$317.2 million** as of June 30, 2023, will be sufficient to fund operations for at least one year from the issuance date of the financial statements[19](index=19&type=chunk)[20](index=20&type=chunk) - The company has significant future potential payment obligations under its license agreements, including up to **$280.0 million** in milestones to Novartis, up to **$90.0 million** to Asana, and up to **$324.0 million** to NiKang[50](index=50&type=chunk)[53](index=53&type=chunk)[57](index=57&type=chunk) - On August 7, 2023, the company sent a notice to terminate its license agreement with The Regents of the University of California, San Francisco (UCSF), with the termination effective October 6, 2023[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses RAS/MAPK pathway therapies, naporafenib's Phase 3 advancement, strategic program deprioritizations, and a cash runway into H2 2025 [Overview](index=23&type=section&id=Overview) Erasca is advancing naporafenib to a pivotal Phase 3 trial in H1 2024 for NRAS-mutated melanoma, strategically deprioritizing other programs to focus resources - The company's lead product candidate is **naporafenib**, a pan-RAF inhibitor, with plans to begin a pivotal Phase 3 trial (SEACRAFT-2) in the first half of 2024 for patients with NRAS-mutated melanoma[95](index=95&type=chunk)[97](index=97&type=chunk) - **ERAS-801**, a CNS-penetrant EGFR inhibitor, received FDA Fast Track Designation for recurrent glioblastoma multiforme (GBM) and Orphan Drug Designation for malignant glioma[103](index=103&type=chunk) - The company has deprioritized its CNS-penetrant KRAS G12C inhibitor, **ERAS-3490**, due to the competitive landscape, before enrolling any patients in its Phase 1 trial[104](index=104&type=chunk) - Strategic updates to the HERKULES clinical trial series include expanding the **ERAS-007** plus EC combination in EC-naïve BRAFm CRC patients while deprioritizing other less promising combinations[100](index=100&type=chunk)[107](index=107&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) For H1 2023, R&D expenses slightly decreased, G&A increased, and a significant rise in interest income led to a reduced net loss of $65.0 million Comparison of Results of Operations (in thousands) | Line Item | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $53,803 | $54,917 | ($1,114) | | In-process research and development | $0 | $2,000 | ($2,000) | | General and administrative | $19,192 | $15,493 | $3,699 | | Total other income, net | $8,015 | $344 | $7,671 | | **Net loss** | **($64,980)** | **($72,066)** | **$7,086** | - The decrease in R&D expenses for H1 2023 was mainly due to lower costs for clinical trials and preclinical studies, partially offset by increased facilities-related expenses and personnel costs[132](index=132&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, Erasca held $365.3 million in cash, projected to fund operations into H2 2025, with future capital needs met via financing or collaborations - The company had cash, cash equivalents, and marketable securities of **$365.3 million** as of June 30, 2023[110](index=110&type=chunk)[139](index=139&type=chunk) - Management believes the current cash position is sufficient to fund operations into the **second half of 2025**[112](index=112&type=chunk)[139](index=139&type=chunk) Summary of Cash Flows (H1 2023 vs H1 2022, in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Operating activities | ($52,309) | ($52,947) | | Investing activities | ($93,953) | ($10,985) | | Financing activities | $832 | $1,452 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk disclosures, including interest rate, foreign currency, and inflation risks, have occurred since the 2022 Annual Report - As of June 30, 2023, there have been no material changes to the company's market risk factors since its 2022 Annual Report on Form 10-K[153](index=153&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective at the reasonable assurance level[155](index=155&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended June 30, 2023[156](index=156&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings but may face claims in the ordinary course of business in the future - The company is not currently a party to any material legal proceedings[158](index=158&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's 2022 Annual Report on Form 10-K - No material changes have occurred to the risk factors set forth in the company's Annual Report on Form 10-K for the year ended December 31, 2022[159](index=159&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales were reported, and $242.1 million from the July 2021 IPO has been used for R&D, consistent with the original prospectus - As of June 30, 2023, the company has used approximately **$242.1 million** of the net proceeds from its IPO for general corporate purposes, including funding R&D of its pipeline programs[162](index=162&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable as the company has no defaults upon senior securities - Not applicable[163](index=163&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[164](index=164&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) Key events include a Lead Independent Director appointment, a board member's resignation, and the UCSF license agreement termination effective October 2023 - The Board of Directors established the position of Lead Independent Director and appointed **James A. Bristol, Ph.D.** to the role[165](index=165&type=chunk) - On August 7, 2023, **Bihua Chen** resigned from the Board of Directors due to compliance policies at her investment fund, not due to any disagreement with the company[166](index=166&type=chunk) - The company terminated its exclusive license agreement with The Regents of the University of California (UCSF), effective October 6, 2023, as it has deprioritized the related research program[167](index=167&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including an amended employment agreement and required CEO/CFO certifications - A list of exhibits filed with the report is provided, including corporate governance documents, an employment agreement, and required CEO/CFO certifications[170](index=170&type=chunk)
Erasca(ERAS) - 2023 Q1 - Quarterly Report
2023-05-14 16:00
Product Development - The company plans to initiate a pivotal Phase 3 trial for its lead product candidate, naporafenib, in NRAS-mutated melanoma patients in the first half of 2024, following a Phase 1b trial in the second half of 2023[94]. - Naporafenib has been dosed in over 500 patients, establishing safety, tolerability, pharmacokinetics, and pharmacodynamics, with clinical proof-of-concept data in combination with trametinib for NRAS-mutated melanoma[94]. - The development strategy for naporafenib could potentially address approximately 3.5 million patients worldwide, significantly expanding the total addressable patient population[95]. - The company has executed a clinical trial collaboration with Novartis for the SEACRAFT-1 trial, where Novartis will provide trametinib at no cost[95]. - ERAS-007 and ERAS-601 are the next most advanced product candidates, targeting downstream and upstream nodes of the RAS/MAPK pathway, respectively[96]. - The HERKULES clinical trials for ERAS-007 are exploring both monotherapy and combinations across multiple tumor types, including NSCLC and CRC[96]. - The FDA granted Fast Track Designation to ERAS-801 for treating adult patients with glioblastoma multiforme with EGFR gene alterations, facilitating early interactions during clinical development[100]. Financial Performance - The net loss for the three months ended March 31, 2023, was $33.2 million, a decrease from a net loss of $36.5 million for the same period in 2022, reflecting a reduction of $3.3 million[106][120]. - Research and development expenses for the three months ended March 31, 2023, were $27.6 million, slightly up from $27.4 million in the same period of 2022, with a notable increase in facilities-related expenses[121]. - General and administrative expenses increased to $9.4 million for the three months ended March 31, 2023, compared to $7.1 million in the same period of 2022, marking an increase of $2.4 million[123]. - Total operating expenses for the three months ended March 31, 2023, were $37.0 million, a slight increase from $36.5 million in the same period of 2022[120]. - Interest income for the three months ended March 31, 2023, was $3.8 million, significantly up from $47,000 in the same period of 2022, primarily due to increased interest earned on cash and marketable securities[124]. - The company reported a net cash used in operating activities of $26.4 million for the three months ended March 31, 2023, compared to $25.8 million for the same period in 2022[132][133]. - Net cash provided by investing activities was $14.7 million for the three months ended March 31, 2023, a significant increase from cash used in investing activities of $1.8 million in the same period of 2022[134]. - Cash generated from financing activities was $0.2 million for the three months ended March 31, 2023, compared to $0.5 million in the same period of 2022[135]. Capital Resources - The company completed a stock offering in December 2022, issuing 15,384,616 shares at $6.50 per share, resulting in net proceeds of $94.9 million[102]. - As of March 31, 2023, the company has raised a total of $765.4 million to fund operations, with cash, cash equivalents, and marketable securities amounting to $389.7 million[105]. - The company expects its cash resources will be sufficient to fund operations into the second half of 2025[107]. - As of March 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $389.7 million, expected to fund operations into the second half of 2025[128]. - The company has no committed sources of capital and plans to finance future cash needs primarily through equity offerings, debt financing, or collaborations[130]. - The company anticipates that future capital requirements will depend on various factors, including the costs and timing of clinical trials and regulatory reviews[129]. - The company faces risks and uncertainties regarding its financial resources, which could deplete sooner than expected due to various operational costs and market conditions[128]. Operational Strategy - The company relies on third parties for manufacturing and distribution of its product candidates, aiming to maintain an efficient infrastructure[101]. - The company has assembled a pipeline of 12 disclosed programs focused on the RAS/MAPK pathway, positioning itself as a leader in precision oncology[90]. - The company has entered into in-license and acquisition agreements for certain intellectual property rights related to product candidates and development programs[110]. - The company incurred no in-process research and development expenses for the three months ended March 31, 2023, compared to $2.0 million for the same period in 2022, which was related to a milestone payment[122].
Erasca (ERAS) Investor Presentation - Slideshow
2023-04-21 15:16
Erasca's Pipeline and Strategy - Erasca is focused on shutting down the RAS/MAPK pathway to address unmet needs in over 5 million patients globally[120] - The company's pipeline targets every node of the RAS/MAPK pathway with multiple clinical-stage compounds[227] - Erasca's strategy involves targeting upstream and downstream RAS/MAPK nodes, clamping oncogenic drivers, and targeting escape routes[238] Naporafenib (Pan-RAF Inhibitor) - Naporafenib, combined with trametinib, demonstrated a 46.7% ORR and 80% DCR in a Phase 1 study for NRASm melanoma[256] - In a Phase 2 study, naporafenib with trametinib showed a 25% ORR and 70.8% DCR in NRASm melanoma[256] - Naporafenib has been dosed in more than 500 patients to date, establishing its safety and tolerability[263] ERAS-007 (ERK1/2 Inhibitor) and ERAS-601 (SHP2 Inhibitor) - A study showed that 23% (6 out of 26) of patients with RAS/MAPK-altered non-CRC solid tumors responded to single-agent ERAS-007 or ERAS-601[130, 143] - ERAS-007 has a longer target residence time compared to other ERKi's, potentially allowing for longer intervals between doses[284] - ERAS-601 demonstrated significant tumor inhibition when combined with cetuximab in triple wildtype CRC and HPV-negative HNSCC models[287] ERAS-801 (CNS-Penetrant EGFR Inhibitor) - ERAS-801 is designed to inhibit EGFR in Glioblastoma Multiforme (GBM), addressing a high unmet need in 37,000 patients in the US and EU[67, 84] - ERAS-801 has a Kp,uu (brain) of 1.2, which is over 4-fold higher than approved EGFR inhibitors[88]
Erasca(ERAS) - 2022 Q4 - Annual Report
2023-03-22 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended DECEMBER 31, 2022 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 or other jurisdiction of incorpo ...
Erasca(ERAS) - 2022 Q3 - Quarterly Report
2022-11-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☑ Smaller reporting company ☑ 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 September 30, 2022 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: 00 ...