Workflow
Erasca(ERAS)
icon
Search documents
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
234 55 55 35 225 120 260 126 10 ERAS-3490 56 1,221 1,687 483 Erasca's naporafenib pan-RAFi could address unmet needs P P P Autophagy MAPK pathway ULK PI3K pathway RAS-GTP GRB2 SHP2 GAP GDP GTP P1 NF1 SOS1 RAF MEK PI3K AKT mTOR RAS-GDP EGFR/ Other FLT3 RTKs MYC GEF ERK naporafenib BRAF CRAF RAS Q61X Solid Tumors 157,000 NRASm Melanoma 54,000 NF1 Loss-of-Function 234,000 BRAF Class II/III Solid 55,000 11 | --- | --- | |--------------------------------------|------------| | Assay | Value (nM) | | Biochemical C ...
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 ...
Erasca(ERAS) - 2022 Q2 - Quarterly Report
2022-08-10 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 June 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 ______________ | --- | --- | |-------------------------------------------------------------------------------------------------------------|---- ...
Erasca(ERAS) - 2022 Q1 - Quarterly Report
2022-05-11 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 March 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 (ERAS) Investor Presentation - Slideshow
2022-02-12 14:40
ERASCA | --- | --- | --- | --- | --- | --- | --- | --- | |--------------|-------|-------|-------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | On a Journey to | | | | | | | | | Erase Cancer | | | | | | | | | Erasca Corporate Presentation | | | | | | | | | | | | | | | January 2022 | | | | | | | | Disclaimer: Forward Looking Statements & Market Data 2 CONFIDENTIAL We caution you that ...