The company continues making progress on its 2024 development priorities:
- Advancing its RAS(ON) multi-selective inhibitor RMC-6236 into monotherapy pivotal trials. As data from the first-in-human clinical study of RMC-6236 continue to mature, the company is preparing to advance RMC-6236 into randomized, controlled, monotherapy pivotal trials. The first trial expected to launch will evaluate RMC-6236 in the second line (2L) treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDAC), followed by the expected launch of a second trial to evaluate RMC-6236 in the 2L treatment of patients with advanced non-small cell lung cancer (NSCLC).
- Expanding the reach of RMC-6236 monotherapy and/or combination regimens into earlier lines of therapy, RAS cancer genotypes beyond RAS G12X, and tumor types beyond NSCLC and PDAC. Objective responses have been observed in second and later line monotherapy treatment of patients with a range of solid tumor types carrying diverse RAS mutation variants. Exploratory clinical studies of several combinations have been initiated to inform potential options for studies in the first line (1L) treatment of metastatic or earlier stage cancers.
- Qualifying its RAS(ON) mutant-selective inhibitors, RMC-6291 (G12C-selective inhibitor) and RMC-9805 (G12D-selective inhibitor), for late-stage development. While first-in-human monotherapy studies for RMC-6291 and RMC-9805 continue, the company has initiated exploratory clinical studies of several combination treatment approaches with these RAS(ON) inhibitors.
“The highly innovative investigational drug RMC-6236 continues to show progress in targeting RAS-addicted solid tumors, and our highest priority is to enable our goal of initiating pivotal monotherapy trials for patients with PDAC and NSCLC this year,” said
Clinical Development Highlights
Plans to Advance RMC-6236 Monotherapy into Pivotal Trials
- Updated Monotherapy Data and Initiation of Pivotal Trials. The company expects to disclose updated clinical safety, tolerability and antitumor activity monotherapy data in the second half of 2024 to support initiation of two pivotal trials of RMC-6236 monotherapy. The first disclosure is expected to support conducting a registrational study of 2L treatment for patients with PDAC, and the second to support a registrational study of 2L treatment for patients with NSCLC. The company expects to initiate both studies in the second half of 2024.
Expanding the
- Initial Clinical Proof of Activity. At the
American Association for Cancer Research (AACR) Annual Meeting 2024 in April, the company shared preclinical data and clinical case studies demonstrating confirmed complete or partial responses in patients with tumors harboring RAS G12, G13 and/or Q61 mutations, including a patient with NRAS Q61K melanoma and a patient with BRAF V600E CRC exhibiting multiple RAS-mediated resistance mechanisms that emerged on prior treatment with a BRAF inhibitor. Scientific Publications . Three original papers describing the mechanistic foundations, discovery and translational research for RMC-6236 and a related tool compound were published in Nature and Cancer Discovery.
Evaluating RMC-6236 in Earlier Lines of Therapy in NSCLC, PDAC and CRC
- RAS(ON) Inhibitor Doublet. Evaluation is ongoing for the combination of RMC-6236 + RMC-6291 in patients with advanced RAS G12C solid tumors, and the company plans to evaluate RMC-6236 + RMC-9805 in patients with advanced RAS G12D solid tumors.
- Standard of Care (SOC) Combinations. Evaluation of RMC-6236 in combination with 1L SOC in PDAC and CRC has been initiated.
- IO Combinations. Evaluation is ongoing for RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS-mutated NSCLC. The company expects to disclose initial clinical pharmacokinetic (PK), safety, tolerability and antitumor activity data for the combination of RMC-6236 + pembrolizumab in the second half of 2024.
Qualifying RMC-6291 for Earlier Lines of Therapy
- Preclinical Data. An oral presentation at the AACR Annual Meeting 2024 showed that, in preclinical models, the combination of RMC-6291 + RMC-6236 demonstrated significant gains in response and durability relative to either monotherapy.
Monotherapy Development . Clinical characterization of RMC-6291 monotherapy safety and efficacy is ongoing.Combination Development . Evaluation of RMC-6291 + RMC-6236 and RMC-6291 + pembrolizumab is ongoing. In addition, the company plans to initiate a combination study of RMC-6291 + RMC-6236 + pembrolizumab as a unique RAS(ON) inhibitor doublet-based, chemotherapy-free regimen in 1L patients with RAS G12C mutated NSCLC. The company expects to disclose initial clinical PK, safety, tolerability and antitumor activity data for the combination of RMC-6291 + pembrolizumab in the first half of 2025.
Qualifying RMC-9805 for Earlier Lines of Therapy
- Preclinical Data. At the AACR Annual Meeting 2024, the company showed that RMC-9805 induces deep and durable regressions in preclinical models of KRAS G12D tumors across several tumor types.
Monotherapy Development . The company expects to disclose initial clinical PK, safety, tolerability and antitumor activity data for RMC-9805 in the second half of 2024.Combination Development . The company plans to evaluate RMC-9805 + RMC-6236 in patients with advanced RAS G12D solid tumors. The company also intends to evaluate RMC-9805 in combination with SOC in one or more tumor types.
RAS Innovation Engine
Beyond the first wave of clinical-stage RAS(ON) inhibitors, additional clinical development opportunities include the RAS(ON) mutant-selective inhibitors RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C) and the RAS companion inhibitors RMC-4630 (
Corporate and Financial Highlights
First Quarter Results
Cash Position: Cash, cash equivalents and marketable securities were
Revenue: Total revenue was zero for the quarter ended
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Financial Guidance
Webcast
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) | ||||||||||||
Three Months Ended March 31, | ||||||||||||
2024 | 2023 | |||||||||||
Revenue: | ||||||||||||
Collaboration revenue | $ | — | $ | 7,014 | ||||||||
Total revenue | — | 7,014 | ||||||||||
Operating expenses: | ||||||||||||
Research and development | 118,021 | 68,947 | ||||||||||
General and administrative | 22,838 | 13,224 | ||||||||||
Total operating expenses | 140,859 | 82,171 | ||||||||||
Loss from operations | (140,859 | ) | (75,157 | ) | ||||||||
Other income (expense), net: | ||||||||||||
Interest income | 23,760 | 7,059 | ||||||||||
Interest and other expense | (2,809 | ) | — | |||||||||
Change in fair value of warrant liability and contingent earn-out shares | 3,905 | — | ||||||||||
Total other income, net | 24,856 | 7,059 | ||||||||||
Loss before income taxes | (116,003 | ) | (68,098 | ) | ||||||||
Benefit (loss) from income taxes | — | — | ||||||||||
Net loss | $ | (116,003 | ) | $ | (68,098 | ) | ||||||
Net loss per share attributable to common stockholders - basic and diluted | $ | (0.70 | ) | $ | (0.72 | ) | ||||||
Weighted-average common shares used to compute net loss per share, basic and diluted | 164,729,200 | 94,831,979 |
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, unaudited) | |||||||||||
2024 | 2023 | ||||||||||
Cash, cash equivalents and marketable securities | $ | 1,703,540 | $ | 1,852,955 | |||||||
Working capital (1) | 1,635,479 | 1,735,430 | |||||||||
Total assets | 1,908,362 | 2,061,705 | |||||||||
Total liabilities | 182,895 | 235,511 | |||||||||
Total stockholders' equity | 1,725,467 | 1,826,194 |
(1) Working capital is defined as current assets less current liabilities.
Media & Investor ContactErin Graves 650-779-0136 egraves@revmed.com
Source:
2024 GlobeNewswire, Inc., source