- Company is winding down global enrollment for the RASolute 302 clinical trial studying daraxonrasib in patients with previously treated PDAC and remains on track for data readout in 2026
- Company has initiated RASolute 304, a Phase 3 clinical trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and remains on track to initiate RASolute 303 for patients with first line metastatic PDAC this year
- Daraxonrasib has received FDA Breakthrough Therapy Designation, Orphan Drug Designation and a Commissioner’s National Priority Voucher
- New leadership appointments strengthened global development and commercialization capabilities
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“Our diverse clinical and preclinical RAS(ON) inhibitor programs continue to make encouraging progress and deliver on important milestones,” said
The company reported significant progress on its near-term strategic priorities:
Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC)
RASolute 302, a global Phase 3 clinical trial of daraxonrasib in patients with previously treated PDAC, is winding down enrollment globally as the company nears completion of enrollment at all
For daraxonrasib in pancreatic cancer, the FDA recently granted an Orphan Drug Designation as well as a Commissioner’s National Priority Voucher supporting accelerated review, in addition to the previously awarded Breakthrough Therapy Designation.
RASolve 301, a global Phase 3 trial of daraxonrasib in patients with previously treated NSCLC, is now enrolling patients in
Advance daraxonrasib into earlier line randomized pivotal trials in patients with PDAC and NSCLC
The company recently disclosed new clinical results supporting initiation of RASolute 303, a global Phase 3 registrational trial of daraxonrasib in first line metastatic PDAC. The company remains on track to initiate the trial this year. The trial will evaluate daraxonrasib as monotherapy and in combination with gemcitabine nab-paclitaxel (GnP), each compared with GnP alone. The company expects to share updated daraxonrasib monotherapy and daraxonrasib plus GnP combination data, each in patients with first line PDAC, including preliminary durability, in the first half of 2026.
The company has initiated RASolute 304, a Phase 3 trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and is currently activating trial sites. The trial will evaluate patients who have received surgery and perioperative chemotherapy per standard of care, who will be randomized to either observation or daraxonrasib monotherapy for two years. The primary endpoint is disease-free survival, with secondary endpoints of overall survival and safety.
The company remains on track to initiate a registrational trial in 2026 evaluating daraxonrasib in patients with first line metastatic RAS mutant NSCLC in combination with pembrolizumab and chemotherapy.
Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination
New elironrasib monotherapy data presented recently at the AACR-NCI-EORTC Symposium on Molecular Targets and
In addition, at the Triple Meeting the company presented encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib, the company’s G12D-selective inhibitor, and daraxonrasib in models of KRAS G12D PDAC, furthering the rationale for this RAS(ON) inhibitor doublet as a therapeutic strategy.
With zoldonrasib’s differentiated profile, the company believes this G12D-selective inhibitor has the potential to contribute as a key component of combination regimens in first line PDAC with current standard of care chemotherapy and/or with daraxonrasib as a RAS(ON) inhibitor doublet. The company expects to initiate a registrational trial for a zoldonrasib combination in patients with first line metastatic PDAC in the first half of 2026 and one or more additional pivotal combination trials in 2026 that incorporate either zoldonrasib or elironrasib.
Zoldonrasib is also being evaluated in a Phase 1 monotherapy expansion cohort in patients with previously treated NSCLC as well as in combination regimens, including zoldonrasib with pembrolizumab or daraxonrasib, in NSCLC.
Progress earlier stage pipeline, including advancing next-generation innovations from the company’s highly productive discovery organization
RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track toward planned initiation of a Phase 1 trial in Q1 2026.
Clinical Collaboration Updates
The company has several discovery and clinical collaborations exploring a range of combinations of a RAS(ON) inhibitor with inhibitors of novel targets, including vopimetostat (TNG462), a PRMT5 inhibitor, under an agreement with Tango Therapeutics, and ivonescimab, a bi-specific PD-1/VEGF inhibitor, under an agreement with Summit Therapeutics.
Other Corporate Updates
In support of the company’s growing late-stage development activities and commercialization plans, the company recently announced the appointment of
Financial Highlights
Third Quarter Results
Cash Position: Cash, cash equivalents and marketable securities were
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Financial Guidance
The company reiterates its full year 2025 GAAP net loss guidance of between
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Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 262,506 | $ | 151,752 | $ | 692,389 | $ | 404,129 | ||||||||
| General and administrative | 52,763 | 23,960 | 128,354 | 69,085 | ||||||||||||
| Total operating expenses | 315,269 | 175,712 | 820,743 | 473,214 | ||||||||||||
| Loss from operations | (315,269 | ) | (175,712 | ) | (820,743 | ) | (473,214 | ) | ||||||||
| Non-operating income (expense): | ||||||||||||||||
| Interest income | 22,083 | 20,411 | 69,402 | 65,658 | ||||||||||||
| Interest expense | (11,428 | ) | — | (12,295 | ) | — | ||||||||||
| Change in fair value of warrant liabilities and contingent earn-out shares | (592 | ) | (1,269 | ) | (2,731 | ) | 4,543 | |||||||||
| Other income (expense), net | — | 282 | (42 | ) | (2,511 | ) | ||||||||||
| Total non-operating income, net | 10,063 | 19,424 | 54,334 | 67,690 | ||||||||||||
| Loss before income taxes | (305,206 | ) | (156,288 | ) | (766,409 | ) | (405,524 | ) | ||||||||
| Net loss | $ | (305,206 | ) | $ | (156,288 | ) | $ | (766,409 | ) | $ | (405,524 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.61 | ) | $ | (0.94 | ) | $ | (4.06 | ) | $ | (2.45 | ) | ||||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 189,231,562 | 166,843,984 | 188,657,560 | 165,576,333 | ||||||||||||
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, unaudited) | ||||||||
2025 | 2024 | |||||||
| Cash, cash equivalents and marketable securities | $ | 1,931,508 | $ | 2,289,299 | ||||
| Working capital (1) | 1,731,867 | 2,163,718 | ||||||
| Total assets | 2,251,920 | 2,558,301 | ||||||
| Total liabilities | 655,016 | 293,097 | ||||||
| Total stockholders' equity | 1,596,904 | 2,265,204 | ||||||
(1) Working capital is defined as current assets less current liabilities.
2025 GlobeNewswire, Inc., source
