UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On May 8, 2024, Erasca, Inc. announced its financial results for the three months ended March 31, 2024. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit Description
99.1 Press Release issued May 8, 2024
104 Cover Page Interactive Data File
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Erasca, Inc. |
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Date: |
May 8, 2024 |
By: |
/s/ Ebun Garner |
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Ebun Garner, General Counsel |
Exhibit 99.1
Erasca Reports First Quarter 2024 Business Updates and Financial Results
Median OS of 13-14 months for naporafenib plus trametinib in pooled analysis of patients with NRASm melanoma
Strengthened balance sheet with private placement financing from high-quality new and existing healthcare-focused investors
Pro forma cash, cash equivalents, and marketable securities of $334 million is expected to fund operations into H2 2026
SAN DIEGO, May 8, 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 March 31, 2024.
“We started 2024 strong with compelling survival data from a pooled analysis of mature data for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma, which showed a near doubling of median overall survival (mOS) versus comparable historical controls,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “These data also catalyzed an oversubscribed $45 million financing from new and existing high-quality investors. We are excited about the potential of this combination to improve both progression free survival and overall survival in patients with aggressive melanoma in need of additional treatment options.”
Dr. Lim continued, “Throughout the year, we expect several data readouts across our clinical programs, including naporafenib (SEACRAFT-1), ERAS-007 (HERKULES-3), and ERAS-801 (THUNDERBBOLT-1). We also expect to initiate our pivotal SEACRAFT-2 trial evaluating naporafenib in the second quarter, with a randomized readout from Stage 1 of the Phase 3 trial anticipated in 2025. With our recent capital infusion and robust balance sheet, we believe that we have extended our cash runway into the second half of 2026 through multiple key inflection points.”
Research and Development (R&D) Highlights
Corporate Highlights
Key Upcoming Milestones
First Quarter 2024 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were $297.7 million as of March 31, 2024, compared to $322.0 million as of December 31, 2023. Erasca expects its pro forma cash, cash equivalents, and marketable securities balance of $334 million (inclusive of the net proceeds received from the 2024 Private Placement) to fund operations into the second half of 2026.
Research and Development (R&D) Expenses: R&D expenses were $28.6 million for the quarter ended March 31, 2024, compared to $27.6 million for the quarter ended March 31, 2023. The increase was primarily driven by an increase in expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, partially offset by a decrease in outsourced services and consulting fees.
General and Administrative (G&A) Expenses: G&A expenses were $10.3 million for the quarter ended March 31, 2024, compared to $9.4 million for the quarter ended March 31, 2023. The increase was primarily driven by increases in legal fees and personnel costs, including stock-based compensation expense.
Net Loss: Net loss was $35.0 million, or $(0.23) per basic and diluted share, for the quarter ended March 31, 2024, compared to $33.2 million, or $(0.22) per basic and diluted share, for the quarter ended March 31, 2023.
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 pipeline 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-007, and ERAS-801; the planned advancement of our development pipeline, including the anticipated timing of data readouts for the SEACRAFT-1 trial, the SEACRAFT-2 trial, the HERKULES-3 trial, and the THUNDERBBOLT-1 trial; the anticipated timing for the initiation of the SEACRAFT-2 trial; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities into the second half of 2026; and our ability to realize the benefits of the CTCSAs described in this press release. 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; we only have three product candidates in clinical development and all of our other development efforts are in the preclinical or development stage; the analysis of pooled Phase 1 and Phase 2 naporafenib plus trametinib data covers two clinical trials with different designs and inclusion criteria, which cannot be directly compared, and therefore may not be a reliable indicator of mOS data; due to differences between trial designs and subject characteristics, comparing data across different trials may not be a reliable indicator of data; 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; we have not completed any clinical trials of naporafenib and are reliant on data generated by Novartis in prior clinical trials conducted by it; our planned SEACRAFT trials may not support the registration of naporafenib; 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, 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; FTD may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval; 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)
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March 31, |
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December 31, |
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2024 |
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2023 |
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Balance Sheet Data: |
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Cash, cash equivalents, and marketable securities |
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$ |
297,685 |
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$ |
321,992 |
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Working capital |
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276,380 |
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294,520 |
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Total assets |
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370,022 |
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395,297 |
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Accumulated deficit |
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(641,030 |
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(606,013 |
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Total stockholders’ equity |
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288,409 |
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316,686 |
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Erasca, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
28,574 |
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$ |
27,585 |
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General and administrative |
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10,277 |
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9,440 |
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Total operating expenses |
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38,851 |
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37,025 |
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Loss from operations |
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(38,851 |
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(37,025 |
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Other income (expense) |
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Interest income |
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3,900 |
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3,877 |
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Other expense, net |
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(66 |
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(51 |
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Total other income (expense), net |
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3,834 |
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3,826 |
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Net loss |
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$ |
(35,017 |
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$ |
(33,199 |
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Net loss per share, basic and diluted |
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$ |
(0.23 |
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$ |
(0.22 |
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Weighted-average shares of common stock used in computing net loss per share, basic and diluted |
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151,161,741 |
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149,504,216 |
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Other comprehensive income (loss): |
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Unrealized (loss) gain on marketable securities, net |
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(287 |
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527 |
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Comprehensive loss |
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$ |
(35,304 |
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$ |
(32,672 |
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MEKINIST® is a registered trademark owned by or licensed to Novartis AG, its subsidiaries, or affiliates.
BRAFTOVI® is a registered trademark owned by or licensed to Pfizer Inc., its subsidiaries, or affiliates.
ERBITUX® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
Source: Erasca, Inc.
Document And Entity Information |
May 08, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | May 08, 2024 |
| Entity Registrant Name | Erasca, Inc. |
| Entity Central Index Key | 0001761918 |
| Entity Emerging Growth Company | true |
| Entity File Number | 001-40602 |
| Entity Incorporation, State or Country Code | DE |
| Entity Tax Identification Number | 83-1217027 |
| Entity Address, Address Line One | 3115 Merryfield Row |
| Entity Address, Address Line Two | Suite 300 |
| Entity Address, City or Town | San Diego |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 92121 |
| City Area Code | (858) |
| Local Phone Number | 465-6511 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Entity Ex Transition Period | false |
| Title of 12(b) Security | Common Stock, $0.0001 par value per share |
| Trading Symbol | ERAS |
| Security Exchange Name | NASDAQ |