Revolution Medicines Reports First Quarter 2024 Financial Results and Update on Corporate Progress
Revolution Medicines, Inc. (Nasdaq: RVMD) released its first quarter 2024 financial results and corporate progress update. The company is advancing its RAS-addicted cancer therapies, such as RMC-6236, into pivotal trials. Plans include expanding therapy reach, qualifying mutant-selective inhibitors, and exploring combination treatments. Despite revenue decline and increased expenses, the company aims to fund operations into 2027.
Revolution Medicines is making progress in advancing RAS-addicted cancer therapies like RMC-6236 into pivotal trials.
The company is exploring combination treatments and advancing therapy reach beyond RAS G12X and tumor types PDAC and NSCLC.
Revolution Medicines has a strong cash position that can fund planned operations into 2027.
Total revenue for the first quarter of 2024 was zero, mainly due to the termination of a collaboration agreement, resulting in a revenue decline.
R&D expenses significantly increased in the first quarter of 2024, primarily due to higher clinical trial expenses and stock-based compensation.
Net loss for the quarter ended March 31, 2024, was $116.0 million, reflecting a negative financial aspect for the company.
Insights
The material decrease in cash position from $1.85 billion to $1.70 billion reflects typical fluctuations resulting from the operational expenditures of a clinical-stage company. The net loss widening from <$68.1 million> to <$116.0 million> is a noteworthy development and the research and development expenses increasing substantially from <$68.9 million> to <$118.0 million> indicates an aggressive investment into the company's pipeline, possibly indicative of the company's confidence in its drug candidates RMC-6236, RMC-6291 and RMC-9805.
However, the absence of revenue for the quarter, compared to last year's <$7.0 million>, underscores the discontinuation of the collaboration with Sanofi, which may raise concerns about the company's ability to monetize its research without strategic partnerships. The guidance projecting a full year 2024 GAAP net loss between <$480 million> and <$520 million> seems to reaffirm the company's commitment to its current development trajectory while anticipating significant non-cash expenses related to stock-based compensation.
For investors, the projection that current assets will fund operations into 2027 offers some assurance of financial stability, but it also implies that there may not be significant revenue streams in the near term. This information suggests a period of continued investment with the expectation of future returns as clinical trials progress.
The advancement of the RAS(ON) multi-selective inhibitor RMC-6236 into pivotal trials for pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) is a critical step towards potential FDA approval and commercialization. Positive results from these trials could open treatment avenues for conditions with high unmet medical needs and potentially drive investor interest, as these are large market indications with significant patient populations.
The exploratory clinical studies of RMC-6236 in combination with other therapies, such as pembrolizumab, indicate a strategy to explore synergistic effects that could lead to more effective treatment regimens. The extension of the drug’s reach into different RAS cancer genotypes and tumor types could considerably broaden the prospective market for RMC-6236.
Investors should note that the drug development process is fraught with risk and the transition from clinical studies to commercial success is far from guaranteed. The upcoming data disclosures for the RAS(ON) inhibitors are pivotal, as they will provide valuable insights into the efficacy and safety profiles of these drugs and could heavily influence the company's valuation and market potential.
Revolution Medicines has delineated an ambitious plan to qualify its inhibitors for late-stage development, aiming to capture a broad spectrum of RAS mutant-selective markets. This indicates strategic positioning to become a prominent player in the oncology segment, particularly for RAS-addicted cancers which have historically been difficult to target.
The company's focus on combination therapies and earlier lines of treatment suggests an understanding of the evolving oncology market, where combination therapies are increasingly becoming the standard of care. Moreover, the move to explore treatment for RAS mutations beyond the common G12C mutation aligns with the trend in personalized medicine, potentially allowing them to capture niche markets that larger pharmaceutical companies might overlook.
Market differentiation for Revolution Medicines may come from their comprehensive 'RAS(ON) innovation engine,' which reflects an extensive pipeline strategy that could sustain long-term growth. The diversification of their portfolio with multiple assets in the pipeline could mitigate risks associated with clinical development and regulatory approval processes.
Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time
REDWOOD CITY, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter ended March 31, 2024, and provided an update on corporate progress.
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 Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “The compelling profile of RMC-6236 is supported by a slate of recent scientific publications and clinical and preclinical presentations at this year’s AACR Annual Meeting that elucidate the basis of this compound’s antitumor activity and safety profile. We have also initiated exploratory clinical studies of key combination approaches, including with our RAS(ON) mutant-selective inhibitors, that may be appropriate for pivotal studies in earlier lines of treatment with RMC-6236.”
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 Reach of RMC-6236 into RAS Cancer Genotypes Beyond RAS G12X and Tumor Types Beyond PDAC and NSCLC
- 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 (SHP2) and RMC-5552 (mTORC1/4EBP1).
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 March 31, 2024, compared to
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Financial Guidance
Revolution Medicines is reiterating its projected full year 2024 GAAP net loss to be between
Webcast
Revolution Medicines will host a webcast this afternoon, May 8, 2024, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: https://ir.revmed.com/events-and-presentations. Following the live webcast, a replay will be available on the company’s website for at least 14 days.
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS companion inhibitors for use in combination treatment strategies. The company’s RAS(ON) inhibitors RMC-6236, a RAS(ON) multi-selective inhibitor, RMC-6291, a RAS(ON) G12C-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor, are currently in clinical development. Additional RAS(ON) mutant-selective inhibitors in the company’s development pipeline include RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C), in addition to RAS companion inhibitors RMC-4630 and RMC-5552.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the company’s financial projections; the company’s development plans and timelines and its ability to advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety and potential efficacy of the company’s candidates being studied; the company’s expectations regarding timing of data disclosures; the company’s plans, priority and timing to expand the reach of RMC-6236 into earlier lines of therapy, various RAS cancer genotypes and additional tumor types; the potential advantages and effectiveness of the company’s clinical and preclinical candidates, including its RAS(ON) inhibitors; and the company’s plans for regulatory engagement and initiation of pivotal and registrational clinical trials for RMC-6236, including data to support initiation of such trials. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," 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’ early stage of development, 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 Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 8, 2024, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
| REVOLUTION MEDICINES, INC. 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 | ||||||||||
| REVOLUTION MEDICINES, INC. SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, unaudited) | |||||||||||
| March 31, 2024 | December 31, 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.
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