RVMD · Revolution Medicines
99 filings
RVMD SEC Filings
Revolution Medicines - 99 total filings
RVMD filed 7 annual reports (10-K), 20 quarterly reports (10-Q) and 72 current reports (8-K) between 2020 and 2026.
- 8-K · Feb 18, 2020
- 8-K · Mar 20, 2020
- 10-K · Mar 30, 2020
- 8-K · Apr 21, 2020
- 10-Q · May 14, 2020
- 8-K · May 14, 2020
- 8-K · Jun 18, 2020
- 8-K · Jun 22, 2020
- 10-Q · Aug 10, 2020
- 8-K · Aug 10, 2020
- 10-Q · Nov 12, 2020
- 8-K · Nov 12, 2020
- 8-K · Feb 1, 2021
- 10-K · Mar 2, 2021
- 8-K · Mar 2, 2021
- 8-K · Mar 8, 2021
- 8-K · Apr 30, 2021
- 8-K · May 10, 2021
- 10-Q · May 10, 2021
- 8-K · Jun 23, 2021
- 10-Q · Aug 11, 2021
- 8-K · Aug 11, 2021
- 8-K · Nov 4, 2021
- 8-K · Nov 10, 2021
- 10-Q · Nov 10, 2021
- 8-K · Jan 11, 2022
- 10-K · Feb 28, 2022
- 8-K · Feb 28, 2022
- 10-Q · May 9, 2022
- 8-K · May 9, 2022
- 8-K · Jun 10, 2022
- 8-K · Jun 21, 2022
- 8-K · Jul 13, 2022
- 8-K · Jul 22, 2022
- 8-K · Aug 9, 2022
- 10-Q · Aug 9, 2022
- 8-K · Sep 1, 2022
- 10-Q · Nov 7, 2022
- 8-K · Nov 7, 2022
- 8-K · Dec 7, 2022
- 8-K · Jan 10, 2023
- 10-K · Feb 27, 2023
- 8-K · Feb 27, 2023
- 8-K · Mar 7, 2023
- 8-K · May 8, 2023
- 10-Q · May 8, 2023
- 8-K · Jun 9, 2023
- 8-K · Aug 1, 2023
- 8-K · Aug 8, 2023
- 10-Q · Aug 8, 2023
- 8-K · Sep 5, 2023
- 8-K · Oct 13, 2023
- 8-K · Oct 23, 2023
- 8-K · Nov 1, 2023
- 10-Q · Nov 6, 2023
- 8-K · Nov 6, 2023
- 8-K · Nov 9, 2023
- 8-K/A · Dec 26, 2023
- 8-K · Jan 9, 2024
- 8-K · Feb 26, 2024
- 10-K · Feb 26, 2024
- 10-Q · May 8, 2024
- 8-K · May 8, 2024
- 8-K · Jun 24, 2024
- 8-K · Jul 15, 2024
- 10-Q · Aug 7, 2024
- 8-K · Aug 7, 2024
- 8-K · Oct 23, 2024
- 8-K · Oct 25, 2024
- 8-K · Nov 6, 2024
- 10-Q · Nov 6, 2024
- 8-K · Dec 2, 2024
- 8-K · Dec 5, 2024
- 10-K · Feb 26, 2025
- 8-K · Feb 26, 2025
- 10-Q · May 7, 2025
- 8-K · May 7, 2025
- 8-K · Jun 18, 2025
- 8-K · Jun 24, 2025
- 8-K · Jun 27, 2025
- 8-K · Aug 6, 2025
- 10-Q · Aug 6, 2025
- 8-K · Sep 10, 2025
- 8-K · Oct 17, 2025
- 10-Q · Nov 5, 2025
- 8-K · Nov 5, 2025
- 10-K · Feb 25, 2026
- 8-K · Feb 25, 2026
- 8-K · Apr 13, 2026
- 8-K · Apr 16, 2026
- 8-K · Apr 17, 2026
- 10-Q · May 6, 2026
- 8-K · May 6, 2026
- 8-K · Jun 22, 2026
- 8-K · Aug 5, 2026
- 10-Q · Aug 5, 2026
- 8-K · Aug 26, 2026
- 8-K · Sep 1, 2026
- 8-K · Oct 13, 2026
Revolution Medicines 8-K Report, Financial Obligation (Oct 13, 2026)
Revolution Medicines, Inc. filed a Form 8-K reporting two related events tied to the U.S. Food and Drug Administration's approval of RASONQUE (daraxonrasib) for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. On October 8, 2026, the company borrowed a $250.0 million Tranche A Loan from Royalty Pharma Development Funding, LLC under the June 23, 2025 loan agreement, which provides a senior secured term loan facility of up to $750.0 million in three tranches. The Tranche A Loan bears interest at three-month Term SOFR (3.50% floor) plus 5.75%, is interest-only, and matures on October 8, 2032. The company also paid a $5.0 million draw fee. Separately, the FDA approval constituted the "Tranche 3 Trigger" under the Royalty Purchase Agreement with Royalty Pharma Investments 2019 ICAV. The company elected not to deliver a Tranche 3 Notice by October 10, 2026, so it will not receive the up to $250.0 million Tranche 3 Purchase Price and Royalty Pharma will not receive the related Tranche 3 Incremental Revenue Participation Right. For both facilities, up to an additional $500.0 million remains potentially available at the company's election, subject to milestones and conditions specified in the respective agreements.
Revolution Medicines 8-K Report, Material Agreement (Sep 1, 2026)
Revolution Medicines, Inc. (RVMD) disclosed in this Form 8-K, filed September 1, 2026, that on August 27, 2026 it agreed to lease the entirety of four buildings at 1600, 1700, 1800 and 1900 Seaport Boulevard in Redwood City, California, comprising approximately 672,000 rentable square feet, to serve as its new headquarters. The transaction consists of four separate leases with four affiliated landlords, subsidiaries of Pacific Shores Phase II Associates, LLC. Commencement dates are staggered from September 26, 2027 through September 1, 2028, with initial terms ending in September 2042, and the company holds options to extend each lease for up to three additional five-year periods. At full commencement, aggregate scheduled monthly base rent will begin at approximately $2.7 million and increase by approximately 3% annually. Rent abatement periods run through January 2030 and represent an aggregate base rent abatement of approximately $23.1 million. The landlords have agreed to aggregate tenant improvement allowances of approximately $115.9 million, with the company able to elect up to approximately $40.3 million in additional allowances, which would be repaid as additional rent amortized at 10% annually. The leases are conditioned on the landlords' acquisition of the underlying properties (the "Phase II Closing"). Base rent is reduced if that closing occurs after November 24, 2026, and the company may terminate if it does not occur by December 31, 2026; each lease automatically terminates if the closing has not occurred by April 29, 2027, absent an agreed extension. The filing also notes that Farallon Capital Management, L.L.C. reported beneficial ownership of approximately 6.4% of the company's common stock as of June 30, 2026, and that Farallon-managed funds indirectly own a majority interest in the landlords.
Revolution Medicines 8-K Report, Corporate Update (Aug 26, 2026)
Revolution Medicines, Inc. (RVMD) reported in a Form 8-K filed August 26, 2026, under Item 8.01 (Other Events) that the U.S. Food and Drug Administration approved RASONQUE™ (daraxonrasib) for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. The approval was based on data from RASolute 302, a global, randomized Phase 3 clinical trial comparing RASONQUE with investigator's choice of cytotoxic chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma. The company stated that the once-daily oral tablets are now available in the United States for physicians to prescribe to eligible patients. The filing states a wholesale acquisition cost of $39,800 for a 30-day supply, based on the recommended daily dose. The filing does not include efficacy results or commercial guidance beyond these points.
Revolution Medicines 8-K Report, Financial Results (Aug 5, 2026)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the quarter ended June 30, 2026 in a press release furnished as Exhibit 99.1 to this Form 8-K, dated August 5, 2026. The company highlighted that the U.S. FDA accepted its New Drug Application for daraxonrasib for previously treated metastatic pancreatic cancer following Phase 3 RASolute 302 results, that it opened an FDA-cleared Expanded Access Program in May 2026 with distribution to physicians on behalf of more than 2,000 patients, and that it achieved U.S. commercial launch readiness and began submissions to the European Medicines Agency under a phased review process. Financially, net loss was $644.4 million for the quarter, compared with $247.8 million a year earlier, including a non-cash $151.0 million charge tied to a change in the fair value of warrants assumed in the acquisition of EQRx, Inc. Research and development expenses rose to $394.9 million from $224.1 million, and general and administrative expenses rose to $110.2 million from $40.6 million. Cash, cash equivalents and marketable securities were $3.9 billion at June 30, 2026, reflecting April 2026 offerings with total gross proceeds of $2,225.0 million and a $250.0 million Royalty Pharma payment received in May 2026. Up to an additional $1.5 billion in committed capital remains under the Royalty Pharma arrangements, subject to milestones. The company updated its full-year 2026 GAAP operating expense guidance to $2.1 to $2.2 billion. On clinical programs, the company reported initial first-line NSCLC data for zoldonrasib and elironrasib in combination with standard of care, and noted FDA Breakthrough Therapy Designation for daraxonrasib in previously treated non-G12C KRAS-mutant NSCLC. The company expects enrollment completion in the Phase 3 RASolve 301 trial this year, with an initial readout anticipated in 2027.
Revolution Medicines Quarterly Report for Q2 Ended Jun 30, 2026
Revolution Medicines, Inc. (RVMD) reported its Form 10-Q for the quarter ended June 30, 2026. The company is a late-stage clinical oncology company developing RAS(ON) inhibitors for RAS-addicted cancers. Net loss widened to $644.4 million for the three months ended June 30, 2026 (versus $247.8 million a year earlier) and to $1,098.2 million for the six months (versus $461.2 million), driven by higher research and development expense ($394.9 million for the quarter), general and administrative expense ($110.2 million), and a $151.0 million non-cash change in fair value of the warrant liability. The company has no approved products and no revenue from product sales. The balance sheet was substantially strengthened in 2026. Cash, cash equivalents and marketable securities totaled $3.9 billion at June 30, 2026, funded largely by an April 2026 public offering of 12,147,887 shares at $142.00 per share (net proceeds of approximately $1,651.4 million), the issuance of $500.0 million of 0.50% convertible senior notes due 2033 (net proceeds approximately $487.1 million), a $250.0 million Tranche 2 payment under the Royalty Purchase Agreement with Royalty Pharma, and at-the-market sales. Management states that existing resources will fund planned operations for at least 12 months. Total liabilities rose to $1.72 billion, including a $548.5 million liability related to the sale of future royalties and $185.3 million of warrant liability. The filing highlights the clinical progress of daraxonrasib, including Phase 3 RASolute 302 results in second-line pancreatic cancer (median overall survival of 13.2 months versus 6.7 months for chemotherapy, hazard ratio 0.40), with an NDA accepted for review by the FDA. Accumulated deficit reached $4.0 billion, and the filing notes that the company has not yet been profitable and expects losses to continue.
Revolution Medicines 8-K Report, Executive Changes (Jun 22, 2026)
Revolution Medicines, Inc. (RVMD) filed this Form 8-K reporting two items: a leadership transition and the results of its annual meeting of stockholders held June 18, 2026. Steve Kelsey, M.D., FRCP, FRCPath, informed the Company on June 18, 2026 of his intent to retire effective January 4, 2027. He will move from his role as president, research and development to senior advisor to the chief executive officer effective July 1, 2026. The Company contemplates appointing him to its Board of Directors effective upon his retirement, subject to Board approval. He will be eligible for certain benefits under the Company's retirement policy for equity awards. At the annual meeting, stockholders elected Alexis Borisy and Mark A. Goldsmith, M.D., Ph.D. as Class III directors to serve until the 2029 annual meeting. Stockholders ratified PricewaterhouseCoopers LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, and approved, on an advisory basis, the compensation of the named executive officers. Of 212,592,561 shares outstanding and entitled to vote as of the April 23, 2026 record date, Borisy received 127,181,172 votes for and 33,660,532 withheld, and Goldsmith received 157,681,628 votes for and 3,160,076 withheld. On the say-on-pay proposal, 155,110,825 shares voted for, 5,554,146 against, and 176,733 abstained. The filing is largely administrative and contains no financial results, guidance, or clinical data. The key forward-looking elements concern the timing of Dr. Kelsey's retirement, his advisory role, and the possible Board appointment, none of which is assured.
Revolution Medicines Quarterly Report for Q1 Ended Mar 31, 2026
Revolution Medicines, Inc. reported a net loss of $453.8 million for the three months ended March 31, 2026, compared with $213.4 million in the same period of 2025, as research and development expenses rose to $344.0 million from $205.7 million and general and administrative expenses rose to $101.3 million from $35.0 million. The company is a late-stage clinical oncology company developing RAS(ON) inhibitors, and the filing notes stock-based compensation of $87.3 million for the quarter, including $44.6 million of incremental expense tied to a retirement-benefit modification of its equity program. As of March 31, 2026, cash, cash equivalents and marketable securities totaled $1.9 billion, the accumulated deficit was $3.3 billion, and the company had no borrowings under its term loan facility. Management states that existing resources will fund planned operations for at least 12 months. Subsequent to quarter end, the company completed concurrent offerings on April 17, 2026, selling 12,147,887 common shares at $142.00 per share for gross proceeds of approximately $1,725.0 million and issuing $500.0 million of 0.50% convertible senior notes due 2033, with net proceeds of approximately $1,650.4 million and $486.8 million, respectively. In May 2026, the company received a $250.0 million Tranche 2 payment from Royalty Pharma under its royalty purchase agreement. The filing also reports topline April 2026 results from the Phase 3 RASolute 302 trial of daraxonrasib in second-line pancreatic cancer, showing a median overall survival of 13.2 months versus 6.7 months for chemotherapy (hazard ratio 0.40), and notes that Amgen terminated its collaboration after discontinuing AMG 193. The quarter's results reflect rising spending on clinical programs, particularly daraxonrasib, zoldonrasib and planned Phase 3 trials, alongside higher non-cash charges. Investors should weigh the growing expense base and the company's reliance on external capital, including the royalty and loan facilities that carry revenue-linked obligations.
Revolution Medicines 8-K Report, Financial Results (May 6, 2026)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the quarter ended March 31, 2026, and provided a corporate update. The most prominent development is positive topline results from the Phase 3 RASolute 302 trial of daraxonrasib in previously treated metastatic pancreatic cancer, where the intent-to-treat population showed a median overall survival of 13.2 months versus 6.7 months for chemotherapy (hazard ratio 0.40; p<0.0001). The company intends to submit these data to global regulators, including a New Drug Application to the FDA under the Commissioner's National Priority Voucher program, and to present them at an ASCO Plenary Session. Financially, net loss widened to $453.8 million for the quarter from $213.4 million a year earlier, driven by higher research and development expenses of $344.0 million (versus $205.7 million) and general and administrative expenses of $101.3 million (versus $35.0 million). Stock-based compensation rose to $87.3 million, including an incremental $44.6 million tied to a new retirement-benefit provision in the equity program. The company raised $2.2 billion in gross proceeds from April 2026 concurrent offerings, and cash, cash equivalents and marketable securities were $1.9 billion as of March 31, 2026. Full-year 2026 GAAP operating expenses guidance was updated to $1.7 to $1.8 billion, and full-year stock-based compensation is now expected to be $260 to $280 million. The filing also outlines pipeline milestones for 2026, including RASolve 301 enrollment, the RASolve 308 trial start in zoldonrasib first-line NSCLC, an elironrasib registrational strategy update, RM-055 first-in-human trial initiation in the fourth quarter, and expansion of commercial leadership in Japan, Asia Pacific and Europe.
Revolution Medicines 8-K Report, Material Agreement (Apr 17, 2026)
On April 17, 2026, Revolution Medicines, Inc. issued $500,000,000 aggregate principal amount of 0.50% Convertible Senior Notes due 2033 under a Base Indenture and a First Supplemental Indenture, both dated April 17, 2026, with U.S. Bank Trust Company, National Association, as trustee. The notes are senior, unsecured obligations, effectively subordinated to secured indebtedness to the extent of the collateral value and structurally subordinated to liabilities of the company's subsidiaries. Interest accrues at 0.50% per year, payable semi-annually on May 1 and November 1, beginning November 1, 2026, and the notes mature on May 1, 2033 unless earlier repurchased, redeemed or converted. The initial conversion rate is 5.0302 shares of common stock per $1,000 principal amount, equal to an initial conversion price of approximately $198.80 per share. Before February 1, 2033, holders may convert only upon certain specified events; from February 1, 2033 they may convert at any time. The company may settle conversions in cash, shares, or a combination, at its election. The company may redeem the notes on or after May 6, 2030 if the stock trades above 130% of the conversion price under specified conditions, and holders may require repurchase at par plus accrued interest upon certain fundamental change events. The filing also states that on April 14, 2026, the company entered into an underwriting agreement with J.P. Morgan Securities LLC, TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the underwriters, for the sale of the $500,000,000 notes, and that the company agreed to indemnify the underwriters against certain liabilities, including under the Securities Act of 1933.
Revolution Medicines 8-K Report, Corporate Update (Apr 16, 2026)
Revolution Medicines, Inc. filed a Form 8-K on April 16, 2026 disclosing the completion of an equity offering of 10,563,381 shares of common stock at a public offering price of $142.00 per share, under an underwriting agreement dated April 14, 2026 with J.P. Morgan Securities LLC, TD Securities (USA) LLC and Guggenheim Securities, LLC as representatives. The underwriters also exercised in full, on April 15, 2026, their 30-day option to purchase an additional 1,584,506 shares. The offering closed on April 16, 2026, and the company expects net proceeds of approximately $1,650.4 million after underwriting discounts, commissions and estimated offering expenses. The shares were sold under an automatic shelf registration statement (File No. 333-277640) filed on March 4, 2024. Concurrently, on April 14, 2026, the company entered into a separate underwriting agreement for the offer and sale of $500,000,000 aggregate principal amount of 0.50% Convertible Senior Notes due 2033. That offering is expected to close on April 17, 2026, subject to customary closing conditions, and the company expects to file a further Current Report on Form 8-K reporting the closing and related transaction documents. The filing also includes customary representations, warranties, covenants and indemnification provisions in the equity underwriting agreement, and a legal opinion from Latham & Watkins LLP regarding the validity of the shares issued.
Revolution Medicines 8-K Report, Corporate Update (Apr 13, 2026)
On April 13, 2026, Revolution Medicines, Inc. disclosed topline results from its global, randomized, controlled Phase 3 RASolute 302 trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Daraxonrasib, taken orally once daily, showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with intravenous standard-of-care cytotoxic chemotherapy. In the overall (intent-to-treat) population, median OS was 13.2 months for daraxonrasib versus 6.7 months for chemotherapy, with a hazard ratio of 0.40 (p < 0.0001). The company described the drug as generally well tolerated with a manageable safety profile and no new safety signals. Based on this first interim analysis, all PFS and OS endpoint results are considered final. The company intends to submit the data to global regulatory authorities, including the U.S. Food and Drug Administration as part of a future New Drug Application under a Commissioner's National Priority Voucher.
Revolution Medicines Annual Report, Year Ended Dec 31, 2025
Revolution Medicines, Inc. (RVMD) is a clinical-stage precision oncology company developing RAS(ON) inhibitors for RAS-addicted cancers. It has never generated product revenue and reported a net loss of $1.13 billion for 2025, up from $600.1 million in 2024, with an accumulated deficit of $2.87 billion as of December 31, 2025. Research and development expense rose to $987.3 million in 2025 from $592.2 million, driven mainly by daraxonrasib, zoldonrasib and elironrasib programs, and general and administrative expense rose to $195.0 million from $97.3 million. The company held $2.0 billion in cash, cash equivalents and marketable securities at December 31, 2025, and states this will fund planned operations for at least 12 months after the filing date. Financing in 2025 included a $250.0 million upfront sale of future royalties to Royalty Pharma, with up to an additional $1.0 billion of potential royalty purchases, and a term loan facility of up to $750.0 million that is drawn only upon specified FDA approval or commercial milestones. In February 2026 the company entered a new at-the-market program with TD Cowen for up to $1 billion. Key near-term catalysts named in the filing include a clinical readout from the RASolute 302 Phase 3 study of daraxonrasib in second-line pancreatic cancer expected in the first half of 2026, and daraxonrasib holds a Commissioner's National Priority Voucher and Breakthrough Therapy Designation in pancreatic cancer. The company has no approved products and relies entirely on third-party manufacturers.
Revolution Medicines 8-K Report, Financial Results (Feb 25, 2026)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate progress update, per Exhibit 99.1 furnished with this Item 2.02 Form 8-K. The company reported Q4 2025 research and development expenses of $294.9 million and general and administrative expenses of $66.7 million, with a net loss of $364.9 million, compared with a net loss of $194.6 million in the fourth quarter of 2024. For full year 2025, R&D expenses were $987.3 million, G&A expenses were $195.0 million, and net loss was $1.1 billion, compared with $600.1 million in 2024. The increases were attributed mainly to clinical trial and manufacturing costs for daraxonrasib, zoldonrasib and elironrasib, and to commercial preparation activities and headcount growth. Cash, cash equivalents and marketable securities totaled $2.0 billion at December 31, 2025, including the first $250 million royalty monetization tranche received in June 2025 from its Royalty Pharma partnership, with an additional $1.75 billion in future committed capital under that arrangement. For 2026, the company expects GAAP operating expenses of $1.6 to $1.7 billion, including estimated non-cash stock-based compensation of $180 to $200 million. The near-term focus is the pivotal RASolute 302 Phase 3 readout of daraxonrasib in second-line metastatic pancreatic cancer (PDAC), expected in the first half of 2026. The company also highlighted five ongoing Phase 3 trials, three additional Phase 3 trials planned to start in 2026, and initial zoldonrasib plus FOLFIRINOX data in first-line PDAC.
Revolution Medicines Quarterly Report for Q3 Ended Sep 30, 2025
Revolution Medicines, Inc. reported its quarterly results for the period ended September 30, 2025 in this Form 10-Q. The company is a clinical-stage precision oncology company developing RAS(ON) inhibitors and has no products approved for commercial sale. For the three months ended September 30, 2025, research and development expenses were $262.5 million and general and administrative expenses were $52.8 million, producing a net loss of $305.2 million, or $1.61 per share, compared with a net loss of $156.3 million in the prior-year quarter. For the nine months ended September 30, 2025, the net loss was $766.4 million, and the accumulated deficit reached $2.5 billion. As of September 30, 2025, the company held $1.9 billion in cash, cash equivalents and marketable securities, which management believes will fund planned operations for at least 12 months from the filing date. During June 2025 the company sold future royalties on daraxonrasib and zoldonrasib to Royalty Pharma for a $250.0 million upfront payment, recorded as a liability of $256.5 million, and entered into a term loan facility of up to $750.0 million, under which no amounts had been drawn. In October 2025, the company sold 3,521,018 shares under its 2024 at-the-market program for gross proceeds of $185.7 million, which the filing describes as a subsequent event. Pipeline milestones highlighted in the filing include the RASolute 302 Phase 3 trial of daraxonrasib in second-line pancreatic cancer, where the company currently expects a clinical readout in 2026, and an FDA Commissioner's National Priority Voucher granted for daraxonrasib in October 2025. Breakthrough Therapy Designation was granted for daraxonrasib in June 2025 and for elironrasib in July 2025.
Revolution Medicines 8-K Report, Financial Results (Nov 5, 2025)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the quarter ended September 30, 2025, and provided a corporate progress update. Research and development expenses were $262.5 million for the quarter, up from $151.8 million a year earlier, driven by clinical trial and manufacturing costs for daraxonrasib, zoldonrasib and elironrasib, plus personnel and stock-based compensation. General and administrative expenses rose to $52.8 million from $24.0 million, and the company posted a net loss of $305.2 million, compared with $156.3 million in the prior-year quarter. For the nine months ended September 30, 2025, net loss was $766.4 million. The company ended the quarter with cash, cash equivalents and marketable securities of $1.93 billion, including the first $250 million royalty monetization tranche received in June 2025 from its Royalty Pharma partnership, with an additional $1.75 billion in future committed capital under that arrangement. The company reiterated its full-year 2025 GAAP net loss guidance of $1.03 billion to $1.09 billion, including estimated non-cash stock-based compensation of $115 million to $130 million. On the clinical front, the company said it is winding down global enrollment in the RASolute 302 Phase 3 trial of daraxonrasib in previously treated pancreatic ductal adenocarcinoma (PDAC), with data readout expected in 2026. It has initiated RASolute 304, a Phase 3 adjuvant PDAC trial, and expects to initiate RASolute 303 in first-line metastatic PDAC this year. Daraxonrasib has received FDA Breakthrough Therapy Designation, Orphan Drug Designation and a Commissioner's National Priority Voucher.
Revolution Medicines 8-K Report, Corporate Update (Oct 17, 2025)
Revolution Medicines, Inc. filed a Form 8-K dated October 16, 2025 to report an event under Item 8.01 (Other Events). On October 16, 2025, the Company announced that the U.S. Food and Drug Administration has granted it a non-transferrable voucher for daraxonrasib, its RAS(ON) multi-selective inhibitor, under the Commissioner's National Priority Voucher pilot program. The filing is brief and does not disclose financial results, trial data, or any quantified financial terms associated with the voucher. Its substance is the regulatory designation itself: the voucher is tied to daraxonrasib and is stated to be non-transferrable, meaning it cannot be sold or assigned to another company under the terms described. For investors, the key takeaway is that daraxonrasib has received a national priority voucher from the FDA. The filing itself does not state the specific benefits, timelines, or conditions attached to the voucher, so any assessment of its commercial or clinical impact must await further company disclosures.
Revolution Medicines 8-K Report, Corporate Update (Sep 10, 2025)
On September 10, 2025, Revolution Medicines, Inc. disclosed under Item 8.01 (Other Events) updated pipeline data for daraxonrasib, its RAS(ON) multi-selective inhibitor, across three settings in RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). In previously treated (second-line or later) patients receiving 300 mg daily from the Phase 1 RMC-6236-001 study, with a June 30, 2025 data cutoff, 83 patients were evaluated for safety; 96% experienced any-grade treatment-related adverse events (TRAEs), 34% had Grade 3 or higher, and none discontinued treatment due to TRAEs. Among 26 patients with RAS G12X tumors, the objective response rate was 35% and disease control rate 92%; among 38 patients with RAS G12X, G13X, or Q61X tumors, these were 29% and 95%. Median progression-free survival was 8.5 months (G12X) and 8.1 months (RAS mutant), and median overall survival was 13.1 months and 15.6 months, respectively. In first-line (treatment-naive) patients receiving daraxonrasib 300 mg daily, with a July 28, 2025 data cutoff, 40 patients were evaluated for safety, with 95% experiencing any-grade TRAEs and 35% Grade 3 or higher; 4 patients (10%) discontinued due to TRAEs. Among 38 efficacy-evaluable patients, the objective response rate was 47% (18 of 38) and disease control rate was 89% (34 of 38). Separately, in the Phase 1 RMC-GI-102 study, daraxonrasib at 200 mg daily combined with gemcitabine and nab-paclitaxel (GnP) in first-line patients showed an objective response rate of 55% (17 of 31) and disease control rate of 90% (28 of 31) among 31 efficacy-evaluable patients; 98% experienced any-grade TRAEs and 58% Grade 3 or higher, with 2 patients (5%) on daraxonrasib and 3 (8%) on GnP discontinuing due to TRAEs. The company stated these preliminary observations support continued development of daraxonrasib in RAS-mutant PDAC and its plans to initiate RASolute 303, a global, randomized Phase 3 trial in first-line metastatic PDAC comparing daraxonrasib monotherapy, daraxonrasib plus GnP, and a GnP control arm. The filing includes standard forward-looking statement cautions noting that prior trial results may not predict future outcomes.
Revolution Medicines 8-K Report, Financial Results (Aug 6, 2025)
Revolution Medicines, Inc. reported financial results for the quarter ended June 30, 2025, and gave an update on corporate progress. Second-quarter research and development expenses were $224.1 million, up from $134.9 million a year earlier, driven mainly by clinical trial and manufacturing costs for daraxonrasib, zoldonrasib and elironrasib. General and administrative expenses were $40.6 million versus $21.7 million, and the net loss was $247.8 million compared with $133.2 million in the prior-year quarter. Cash, cash equivalents and marketable securities totaled $2.1 billion as of June 30, 2025, including the first $250 million royalty monetization tranche from Royalty Pharma. The company highlighted progress on its Phase 3 program. Enrollment in RASolute 302, a global Phase 3 trial of daraxonrasib in previously treated pancreatic ductal adenocarcinoma (PDAC), is being wound down in the U.S. while enrollment continues outside the U.S.; the company expects enrollment to complete this year, with a data readout expected in 2026. The company also received FDA Breakthrough Therapy Designations for daraxonrasib (previously treated metastatic PDAC with KRAS G12 mutations) and elironrasib (KRAS G12C NSCLC). Plans for 2026 include initiating registrational trials of daraxonrasib in first-line metastatic PDAC and as adjuvant treatment for resectable PDAC, and a Phase 3 trial in first-line RAS mutant NSCLC. For full-year 2025, Revolution Medicines projects a GAAP net loss between $1.03 billion and $1.09 billion, including estimated non-cash stock-based compensation of $115 million to $130 million. The company also entered a $2 billion flexible funding agreement with Royalty Pharma, providing capital upon achievement of agreed milestones through a mix of synthetic royalty and debt instruments, and announced a clinical collaboration with Summit Therapeutics to evaluate its RAS(ON) inhibitors with ivonescimab.
Revolution Medicines Quarterly Report for Q2 Ended Jun 30, 2025
Revolution Medicines, Inc. (RVMD) reported its Form 10-Q for the quarter ended June 30, 2025, describing itself as a clinical-stage precision oncology company developing RAS(ON) inhibitors for RAS-addicted cancers. Research and development expense rose to $224.1 million for the three months ended June 30, 2025, from $134.9 million a year earlier, and net loss widened to $247.8 million from $133.2 million. For the six months, net loss was $461.2 million versus $249.2 million. The company reported $2.1 billion in cash, cash equivalents and marketable securities and an accumulated deficit of $2.2 billion, and states that existing resources will fund planned operations for at least 12 months. The most significant financing event was a June 2025 revenue participation right purchase and sale agreement with Royalty Pharma, under which Royalty Pharma paid an upfront $250.0 million in exchange for tiered royalties on worldwide net sales of daraxonrasib (RMC-6236) and, if approved for an overlapping indication, zoldonrasib (RMC-9805). The filing also describes up to $1.0 billion of additional potential royalty purchases tied to milestones, and a senior secured term loan facility of up to $750.0 million from Royalty Pharma Development Funding, LLC, none of which had been drawn as of June 30, 2025. The company lists a Phase 3 RASolute 302 trial of daraxonrasib in second-line pancreatic cancer with an expected clinical readout in 2026, and notes that daraxonrasib received FDA Breakthrough Therapy Designation in June 2025. The filing notes that no company product has been approved for commercial sale and that the company has never generated product revenue. Investors should weigh the rapid increase in operating expenses, the royalty and loan obligations that restrict operating flexibility and are secured by company assets, and the dependence on the outcome of pivotal trials.
Revolution Medicines 8-K Report, Shareholder Vote Results (Jun 27, 2025)
Revolution Medicines, Inc. (RVMD) filed this Form 8-K to report the results of its 2025 annual meeting of stockholders, held on June 26, 2025. As of the April 28, 2025 record date, 186,261,742 shares of common stock were outstanding and entitled to vote. Stockholders voted on three proposals, each described in the company's definitive proxy statement filed on Schedule 14A on April 29, 2025. Stockholders elected four Class II directors, Frank K. Clyburn, Jr., Sandra J. Horning, M.D., Sushil Patel, Ph.D., and Thilo Schroeder, Ph.D., to serve until the 2028 annual meeting. Clyburn received 147,380,169 votes for and 512,898 withheld, while the other three nominees received between 119,696,091 and 126,396,068 votes for, with between 21,496,999 and 28,196,976 withheld. Stockholders also ratified PricewaterhouseCoopers LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, with 157,875,830 votes for, 214,963 against, and 43,938 abstentions. In a non-binding advisory vote, stockholders approved the compensation of the company's named executive officers, with 145,265,825 votes for, 2,597,920 against, 29,322 abstentions, and 10,241,664 broker non-votes. No other items were presented for stockholder approval at the meeting.
Revolution Medicines 8-K Report, Material Agreement (Jun 24, 2025)
Revolution Medicines, Inc. (Nasdaq: RVMD) entered into a Royalty Purchase Agreement and a Loan Agreement on June 23, 2025 with Royalty Pharma, together described as Strategic Financing Agreements providing up to $2 billion in committed capital. Under the royalty agreement, Royalty Pharma paid an upfront $250.0 million in exchange for tiered royalty payments on worldwide net sales of daraxonrasib (RMC-6236) and, if approved for the same indication, zoldonrasib (RMC-9805). Additional royalty tranches totaling up to $1.0 billion of further funding are available at the company's election upon specified triggers, including a positive RASolute 302 readout in second-line pancreatic ductal adenocarcinoma (PDAC) and FDA approval milestones. Total royalty rates for the full scenario are 7.80% on the first $2 billion of annual net sales, 4.55% on $2 billion to $4 billion, and 2.40% on $4 billion to $8 billion. The Loan Agreement provides a senior secured term loan facility of up to $750.0 million from Royalty Pharma Development Funding, LLC, administered by Wilmington Trust, National Association. The first $250.0 million tranche must be drawn within 45 days of FDA marketing approval of daraxonrasib for metastatic PDAC if approval occurs by January 1, 2028. The Term Loans bear interest at three-month term SOFR (3.50% floor) plus 5.75%, interest is payable quarterly, there is no scheduled amortization, and the facility matures on the earlier of six years after the first funding date and December 31, 2032. The filing also states the company is removing its cash runway end date guidance, withdrawing its prior 2025 GAAP net loss guidance pending evaluation of accounting treatment, and is pursuing independent global development and commercialization of its RAS(ON) inhibitor portfolio. The company's press release states that it retains full strategic and executional control of product development and commercialization. Investors should note the royalty obligations apply for 15 years on certain sales, the loan includes a change-of-control prepayment requirement and secured liens over substantially all company assets, and the agreements contain customary restrictive covenants but no financial covenants.
Revolution Medicines 8-K Report, Executive Changes (Jun 18, 2025)
Revolution Medicines, Inc. (RVMD) filed a Form 8-K on June 18, 2025 under Item 5.02 (Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers) to disclose a board change. Barbara Weber, M.D., communicated her decision to resign from the Company's Board of Directors, including her roles as a director, member of the Nominating and Corporate Governance Committee, and member of the Research & Development Committee. The resignation is effective immediately prior to the Company's 2025 annual meeting of stockholders, scheduled for 7:30 a.m. PT on June 26, 2025. The filing states that Dr. Weber's resignation is connected to the activation of the clinical study under the ongoing collaboration between the Company and Tango Therapeutics, Inc. The filing explicitly states that the resignation was not the result of any disagreement with the Company or any matter relating to the Company's operations, policies or practices. For investors, this is a governance update rather than a financial disclosure. The filing contains no financial results, financial figures, or guidance. Its most notable element is the link between the director's departure and an active clinical study under the existing Tango Therapeutics collaboration.
Revolution Medicines 8-K Report, Financial Results (May 7, 2025)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported its financial results for the quarter ended March 31, 2025 in a press release furnished as Exhibit 99.1 to this Form 8-K. The company reported research and development expenses of $205.7 million (versus $118.0 million a year earlier) and general and administrative expenses of $35.0 million (versus $22.8 million), resulting in a net loss of $213.4 million, or $1.13 per share, compared with a net loss of $116.0 million, or $0.70 per share, for the prior-year quarter. Cash, cash equivalents and marketable securities totaled $2.1 billion as of March 31, 2025. The company reiterated its full-year 2025 GAAP net loss guidance of $840 million to $900 million, including estimated non-cash stock-based compensation of $115 million to $130 million, and said current cash can fund planned operations into the second half of 2027. On the clinical front, the company highlighted its two ongoing Phase 3 trials of daraxonrasib: RASolute 302 in previously treated pancreatic ductal adenocarcinoma, where enrollment is expected to substantially complete this year to enable a data readout in 2026, and RASolve 301 in previously treated non-small cell lung cancer, where sites are being activated. Planned registrational trials of daraxonrasib in first-line metastatic and adjuvant PDAC are expected to start in the second half of 2025. The company also presented early data for its RAS(ON) inhibitors zoldonrasib, elironrasib and daraxonrasib in NSCLC, including combination data, and plans one or more pivotal combination trials in 2026. Corporate updates include the appointment of Anthony Mancini as chief global commercialization officer, who will oversee commercialization strategy and operations as the company prepares for a potential launch. The company also said RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track to reach a clinic-ready stage later this year, with Phase 1 initiation expected in 2026.
Revolution Medicines Quarterly Report for Q1 Ended Mar 31, 2025
Revolution Medicines, Inc. reported a net loss of $213.4 million for the three months ended March 31, 2025, compared with $116.0 million in the prior-year period. Research and development expenses rose to $205.7 million from $118.0 million, driven mainly by daraxonrasib, zoldonrasib and elironrasib clinical trial and manufacturing costs, higher headcount and stock-based compensation. General and administrative expenses increased to $35.0 million from $22.8 million. The accumulated deficit reached $2.0 billion, and total stockholders' equity was $2.08 billion at March 31, 2025. As of March 31, 2025, the company held $2.1 billion in cash, cash equivalents and marketable securities, including $333.6 million of cash and cash equivalents and $1.77 billion of marketable securities. Management believes these resources will fund planned operations for at least 12 months following the filing date. The filing states the company will require substantial additional financing for its development efforts and has no committed external source of funds. No shares were sold under the 2024 at-the-market program during the quarter. The filing describes the company's pipeline of RAS(ON) inhibitors. The Phase 3 RASolute 302 trial of daraxonrasib in second-line pancreatic cancer is ongoing, with an expected clinical readout in 2026, and the RASolve 301 non-small cell lung cancer trial is being activated. The company also disclosed updated clinical data for daraxonrasib, elironrasib and zoldonrasib on May 7, 2025, as described in the filing. The company reports no product revenue and expects operating losses to continue.
Revolution Medicines Annual Report, Year Ended Dec 31, 2024
Revolution Medicines, Inc. (RVMD) is a clinical-stage precision oncology company developing RAS(ON) inhibitors for RAS-addicted cancers. It has never generated product revenue; collaboration revenue fell to zero in 2024 from $11.6 million in 2023 after the Sanofi Agreement was terminated in June 2023. Net loss widened to $600.1 million in 2024 from $436.4 million in 2023, and the accumulated deficit reached $1.7 billion. Research and development expense rose to $592.2 million, and general and administrative expense to $97.3 million. Cash, cash equivalents and marketable securities totaled $2.3 billion at year-end 2024, and management states these fund planned operations for at least 12 months. The lead asset, daraxonrasib (RMC-6236), is in a global Phase 3 registrational trial (RASolute 302) in second-line metastatic pancreatic cancer, with an expected clinical readout in 2026. A second Phase 3 trial (RASolve 301) in RAS-mutated non-small cell lung cancer is being activated. Company-reported Phase 1 data included an ORR of 36% (8 of 22 patients) in KRAS G12X pancreatic patients and 38% (15 of 40) in NSCLC efficacy-evaluable patients. Elironrasib and zoldonrasib are in earlier clinical development, and the company plans pivotal combination studies in 2026. In December 2024 the company completed an underwritten offering with net proceeds of $823.0 million at $46.00 per share, following the November 2023 EQRx acquisition that added $1.1 billion in net cash. The filing also discloses a pending Delaware lawsuit (Nemeth v. Casdin) tied to the EQRx merger, for which the company cannot estimate a range of loss.
Revolution Medicines 8-K Report, Financial Results (Feb 26, 2025)
Revolution Medicines, Inc. reported financial results for the quarter and year ended December 31, 2024, and provided an update on corporate progress in a press release furnished as Exhibit 99.1. For the full year 2024, the company reported zero total revenue (compared to $11.6 million in 2023, a decline attributed to the termination of its Sanofi collaboration in 2023), research and development expenses of $592.2 million (up from $423.1 million), general and administrative expenses of $97.3 million (up from $75.6 million), and a net loss of $600.1 million (up from $436.4 million). For the fourth quarter, net loss was $194.6 million versus $161.5 million a year earlier. Cash, cash equivalents and marketable securities were $2.3 billion at December 31, 2024, up from $1.9 billion, primarily reflecting an upsized public equity offering in December 2024 that raised $823 million in net proceeds. The company's near-term focus is on its RAS(ON) inhibitor pipeline, led by daraxonrasib. It anticipates substantially completing enrollment in the Phase 3 RASolute 302 trial in previously treated metastatic pancreatic cancer during 2025, with an expected data readout in 2026. It is activating sites for the Phase 3 RASolve 301 trial in previously treated non-small cell lung cancer, and anticipates initiating two additional pivotal trials of daraxonrasib in earlier lines of pancreatic cancer treatment in the second half of 2025. Management stated it plans to retain control of U.S. commercial rights while preparing for a potential launch, and is exploring strategies for serving patients outside the U.S. For 2025, the company expects a full-year GAAP net loss between $840 million and $900 million, including estimated non-cash stock-based compensation of $115 million to $130 million. It projects that current cash, cash equivalents and marketable securities can fund planned operations into the second half of 2027.
Revolution Medicines 8-K Report, Corporate Update (Dec 5, 2024)
Revolution Medicines, Inc. (RVMD) disclosed under Item 8.01 that on December 3, 2024 it entered into an underwriting agreement with J.P. Morgan Securities LLC, TD Securities (USA) LLC, Goldman Sachs & Co. LLC and Guggenheim Securities, LLC, as representatives of the underwriters, for a public offering of common stock and pre-funded warrants. The Company agreed to issue and sell 14,130,436 shares of common stock at $46.00 per share and pre-funded warrants to purchase 2,173,917 shares at $45.9999 per warrant, with the underwriters purchasing at $43.93 per share and $43.9299 per pre-funded warrant. The underwriters also received a 30-day option to buy up to 2,445,652 additional shares at the public offering price. The offering was made under a prospectus supplement and the Company's automatically effective shelf registration statement on Form S-3 (Registration No. 333-277640). The offering closed on December 5, 2024, with an aggregate of 16,576,088 shares of common stock sold, including the full exercise of the underwriters' option, plus pre-funded warrants for 2,173,917 shares. The Company reported net proceeds of approximately $823.0 million after underwriting discounts, commissions and estimated offering expenses. The Company agreed to indemnify the underwriters against certain liabilities, including under the Securities Act of 1933, and it and its directors and executive officers agreed to a 45-day lock-up on sales or transfers of common stock, subject to exceptions described in the prospectus supplement.
Revolution Medicines 8-K Report, Corporate Update (Dec 2, 2024)
On December 2, 2024, Revolution Medicines, Inc. furnished pipeline updates under Item 8.01 (Other Events) covering its RAS(ON) inhibitors RMC-6236 and RMC-6291. For RMC-6236 monotherapy at 300 mg daily in previously treated RAS-mutant pancreatic ductal adenocarcinoma (data cutoff July 23, 2024; 76 patients), the company reported rash and gastrointestinal events as the most common treatment-related adverse events, one Grade 4 TRAE (platelet count decreased) and no Grade 5 TRAEs. In 2L metastatic PDAC, the objective response rate was 36% (8 of 22) for KRAS G12X tumors and 27% (10 of 37) for G12X, G13X, or Q61X tumors, with median progression-free survival of 8.8 months and 8.5 months, respectively. Preliminary median overall survival was not estimable for either group. In NSCLC (data cutoff September 30, 2024; 124 patients across 120 mg to 300 mg daily), the company stated RMC-6236 was generally well tolerated at 120 mg to 220 mg daily, with more TRAEs at 300 mg daily, and reported one Grade 4 pneumonitis at 300 mg daily. In RAS G12X NSCLC efficacy-evaluable patients who had received one or two prior lines of therapy, the ORR was 38% (15 of 40), median PFS was 9.8 months and median OS was 17.7 months. The company said these data support plans for a global, randomized Phase 3 trial of RMC-6236 versus docetaxel. The filing also reported early combination data: RMC-6236 with pembrolizumab in 20 patients (October 28, 2024 cutoff), RMC-6236 with RMC-6291 in 74 patients, including 25% ORR (3 of 12) in previously treated colorectal cancer, and RMC-6291 with pembrolizumab in 15 patients. The company described these combinations as generally well tolerated and as supporting further evaluation, including a possible chemotherapy-sparing triplet in first-line NSCLC.
Revolution Medicines Quarterly Report for Q3 Ended Sep 30, 2024
Revolution Medicines, Inc. reported its Form 10-Q for the quarter ended September 30, 2024. The company is a clinical-stage precision oncology company developing RAS(ON) inhibitors and RAS Companion Inhibitors. It has no product revenue; collaboration revenue was zero for the three and nine months ended September 30, 2024, versus $10.8 million for the nine months ended September 30, 2023, following the termination of the Sanofi Agreement in June 2023. Net loss was $156.3 million for the quarter and $405.5 million for the nine months, compared with $108.4 million and $274.8 million a year earlier. Research and development expense rose to $151.8 million for the quarter and $404.1 million year to date, driven mainly by RMC-6236 clinical trial costs and headcount growth. As of September 30, 2024, cash, cash equivalents and marketable securities totaled $1.5 billion ($201.3 million in cash and cash equivalents plus $1.35 billion in marketable securities), against an accumulated deficit of $1.5 billion. Management believes existing resources will fund planned operations for at least 12 months following the filing. The company raised $74.3 million net under its at-the-market programs during the nine months, and it established a new $500 million at-the-market program with TD Cowen in August 2024. Management states it will require substantial additional financing for its development programs. The filing highlights the RASolute 302 Phase 3 registrational trial of RMC-6236 in second-line metastatic pancreatic ductal adenocarcinoma, which is ongoing with an event-driven readout, and plans for a Phase 3 trial in NSCLC expected to start in the first quarter of 2025. Subsequent to quarter end, the company amended its Redwood City lease to add approximately 46,961 square feet at 600 Saginaw Drive, with initial annual base rent of about $3.3 million.
Revolution Medicines 8-K Report, Financial Results (Nov 6, 2024)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the quarter ended September 30, 2024 in a press release furnished as Exhibit 99.1 under Item 2.02. The company reported no revenue for the quarter, compared with $0 in the prior-year quarter, while research and development expenses rose to $151.8 million from $107.7 million and general and administrative expenses rose to $24.0 million from $15.5 million. Net loss was $156.3 million for the quarter, versus $108.4 million a year earlier, and net loss per share was $0.94 compared with $0.99. Cash, cash equivalents and marketable securities totaled $1.55 billion as of September 30, 2024. The company reiterated its full-year 2024 GAAP net loss guidance of $560 million to $600 million and said its current cash can fund planned operations into 2027. Clinical updates in the release centered on RAS(ON) inhibitors. The company said a Phase 3 registrational study, RASolute 302, of RMC-6236 in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) was underway, with first patient dosed on October 21, 2024 and a data readout timed to enrollment completion. Initial data for RMC-9805, a RAS(ON) G12D-selective inhibitor, were reported in KRAS G12D PDAC, described as showing an encouraging safety and tolerability profile and initial antitumor activity. The company said it expects an update on its lung cancer programs in the fourth quarter of 2024. The filing itself is a short notice; the financial figures above come from the press release and balance sheet data included with the exhibit. Management said it expects to provide additional updates before year-end to support pipeline progress in 2025.
Revolution Medicines 8-K Report, Corporate Update (Oct 25, 2024)
On October 25, 2024, Revolution Medicines, Inc. reported preliminary clinical safety, tolerability and activity data for RMC-9805, its RAS(ON) oral tri-complex G12D-selective inhibitor, from its monotherapy first-in-human study (RMC-9805-001), with a data cutoff date of September 2, 2024, in patients with previously treated solid tumors harboring KRAS G12D mutations. Across 179 treated patients (doses from 150 mg to 1,200 mg once daily and 300 mg to 600 mg twice daily), the most common treatment-related adverse events were gastrointestinal, led by nausea (30% any grade) and diarrhea (16%). TRAEs led to dose reduction in approximately 3% of patients, no TRAEs led to treatment discontinuation, and no treatment-related Grade 4 or 5 adverse events or serious adverse events were reported. Median time on treatment was 2.8 months. In the 99 patients who received 1,200 mg per day, the most common TRAEs were again gastrointestinal-related plus rash, with dose reductions in approximately 4% and no discontinuations. For 20 second-line-or-later pancreatic ductal adenocarcinoma patients treated at 1,200 mg per day who received a first dose at least 14 weeks before the cutoff, the objective response rate (including confirmed and pending responses) was 30% and the disease control rate was 80%. The company states these preliminary data support continued development of RMC-9805 as a single agent and in combination with other therapies, including its RAS(ON) multi-selective inhibitor RMC-6236.
Revolution Medicines 8-K Report, Corporate Update (Oct 23, 2024)
On October 23, 2024, Revolution Medicines, Inc. disclosed updated clinical data for RMC-6236, its RAS(ON) multi-selective inhibitor, from the monotherapy first-in-human Phase 1 RMC-6236-001 study, with a data cutoff of July 23, 2024, in patients with previously treated pancreatic ductal adenocarcinoma (PDAC). Across 127 patients treated at doses from 160 mg to 300 mg daily, 98% experienced a treatment-related adverse event (TRAE), 29% at Grade 3 or higher. The most common TRAEs were rash (91%, with 8% at Grade 3 or higher) and gastrointestinal effects such as diarrhea (48%) and nausea (43%). One Grade 4 TRAE (platelet count decreased) and no Grade 5 TRAEs were observed, and no TRAEs led to treatment discontinuation, though 35% led to dose modifications. Preliminary efficacy data in metastatic PDAC showed median progression-free survival of 8.5 months in second-line patients with KRAS G12X mutations (95% CI: 5.3–11.7 months) and 4.4 months in third-line or later patients with the same mutation (95% CI: 4.2–6.4 months). In second-line patients, median overall survival was 14.5 months for both KRAS G12X and G12/G13/Q61 tumors, with a 6-month OS rate of 89% and 91%, respectively. For patients first dosed at least 14 weeks before the cutoff, objective response rate was 29% in second-line and 22% in third-line or later patients, and disease control rate was 91% and 89%. The filing is a pipeline update under Item 8.01 and references the company's Form 10-Q filed August 7, 2024, for risk factors. The data are preliminary and drawn from a single-arm Phase 1 study, and the filing includes forward-looking statements about the drug's potential safety, tolerability, efficacy and durability.
Revolution Medicines 8-K Report, Financial Results (Aug 7, 2024)
Revolution Medicines, Inc. reported its financial results for the quarter ended June 30, 2024, and gave an update on corporate progress. The company reported no revenue for the quarter, compared with $3.8 million for the quarter ended June 30, 2023, which it attributed to the termination of its Sanofi collaboration agreement in 2023. Research and development expenses rose to $134.9 million from $98.0 million, and general and administrative expenses rose to $21.7 million from $14.6 million. Net loss was $133.2 million for the quarter, compared with $98.3 million a year earlier, and net loss per share was $0.81. Cash, cash equivalents and marketable securities totaled $1.59 billion as of June 30, 2024. The company's clinical focus is RMC-6236, a RAS(ON) multi-selective inhibitor. It plans to start a Phase 3 registrational trial, RASolute 302, in second-line metastatic pancreatic ductal adenocarcinoma this year, following preliminary data showing median PFS of 7.6 months to 8.1 months depending on mutation group. The company also expects to start a registrational study in previously treated non-small cell lung cancer in the fourth quarter of 2024, and it plans to evaluate RMC-6236 in earlier lines of therapy. Management reiterated 2024 GAAP net loss guidance of $560 million to $600 million and stated that current cash can fund planned operations into 2027. Separately, the board increased its size to ten directors and appointed Frank K. Clyburn, Jr. as an independent Class II director, with a term expiring at the 2025 annual meeting. Mr. Clyburn previously served as CEO of International Flavors & Fragrances and held senior oncology leadership roles at Merck, including leading the Keytruda franchise. He received an option to purchase 27,744 shares and 6,932 restricted stock units under the company's director compensation program.
Revolution Medicines Quarterly Report for Q2 Ended Jun 30, 2024
Revolution Medicines, Inc. reported its Form 10-Q for the quarter ended June 30, 2024. The company is a clinical-stage precision oncology company developing RAS(ON) inhibitors and RAS Companion Inhibitors. It recorded no collaboration revenue in the three and six months ended June 30, 2024, compared with $3.8 million and $10.8 million in the same periods of 2023, because the Sanofi agreement terminated in June 2023. Net loss was $133.2 million for the quarter and $249.2 million for the six months, versus $98.3 million and $166.4 million a year earlier. Research and development expense rose to $134.9 million for the quarter and $253.0 million for the six months, and general and administrative expense rose to $21.7 million and $44.5 million, respectively. As of June 30, 2024, cash, cash equivalents and marketable securities totaled $1.6 billion, and the accumulated deficit was $1.4 billion. Management states that existing resources will fund planned operations for at least 12 months after the filing, while also stating that substantial additional financing will be required. Subsequent events include a July 2024 sale of 1,294,050 shares under the 2021 ATM Program for gross proceeds of $60.8 million, and an August 2024 agreement with TD Securities (USA) LLC for a new at-the-market program of up to $500 million, which replaces the 2021 program. Clinically, the filing describes RMC-6236 (RAS(ON) multi-selective) data from the RMC-6236-001 study as of a May 11, 2024 cutoff, including a 7.6-month median PFS in second-line metastatic PDAC for patients with G12X, G13X and Q61X mutations, and plans for a Phase 3 RASolute 302 study expected to start in the second half of 2024. Updated NSCLC data and several combination readouts are expected in the fourth quarter of 2024.
Revolution Medicines 8-K Report, Regulation FD Disclosure (Jul 15, 2024)
On July 15, 2024, Revolution Medicines, Inc. disclosed under Item 7.01 that it expects its net loss for the year ended December 31, 2024 to be between $560 million and $600 million, including estimated non-cash stock-based compensation expense of approximately $70 million to $80 million. The Company confirmed it continues to project that its current cash, cash equivalents and marketable securities can fund planned operations into 2027. Under Item 8.01, the Company reported updated data for RMC-6236, its RAS(ON) multi-selective inhibitor, from the monotherapy first-in-human RMC-6236-001 study as of a May 11, 2024 data cutoff in previously treated pancreatic ductal adenocarcinoma (PDAC). Across 127 patients treated at 160 mg to 300 mg daily, 96% had any treatment-related adverse event, with 22% at Grade 3 or higher; the most common were rash (87%) and gastrointestinal toxicities such as diarrhea (46%) and nausea (43%). Median progression-free survival (PFS) in the second-line setting was 8.1 months for patients with KRAS G12X mutations and 7.6 months for G12X, G13X and Q61X PDAC, compared with the Company's estimated 2.0 to 3.5 months for certain second-line chemotherapy trials. The objective response rate was 20% to 27% for KRAS G12X patients depending on time since first dose, versus an estimated mean of 9% in the chemotherapy trials. The Company said these preliminary results support planned initiation of RASolute 302, a global randomized Phase 3 trial of RMC-6236 at 300 mg daily versus investigator's choice chemotherapy in second-line metastatic PDAC, which it expects to start in the second half of 2024. The trial design and dose remain subject to final protocol submission and FDA review.
Revolution Medicines 8-K Report, Shareholder Vote Results (Jun 24, 2024)
On June 20, 2024, Revolution Medicines, Inc. held its 2024 annual meeting of stockholders. As of the April 22, 2024 record date, 170,493,095 shares of common stock were outstanding and entitled to vote, including 5,560,000 contingent earn-out shares. The filing reports the results of three proposals described in the company's April 25, 2024 proxy statement. Stockholders elected three Class I directors, Elizabeth McKee Anderson, Flavia Borellini, Ph.D., and Lorence Kim, M.D., to serve until the 2027 annual meeting. Anderson received 107,146,109 votes for and 23,367,071 withheld, Borellini received 107,339,633 for and 23,173,547 withheld, and Kim received 97,387,991 for and 33,125,189 withheld. Each nominee had 17,669,340 broker non-votes. Stockholders also ratified PricewaterhouseCoopers LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024, with 148,105,275 votes for, 9,895 against, and 67,350 abstentions. In a non-binding advisory vote, stockholders approved the compensation of the named executive officers, with 128,861,403 votes for, 1,624,748 against, 27,029 abstentions, and 17,669,340 broker non-votes. No other items were presented for stockholder approval.
Revolution Medicines 8-K Report, Financial Results (May 8, 2024)
Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported its financial results for the quarter ended March 31, 2024. Total revenue was zero, compared to $7.0 million in the prior-year quarter, reflecting the termination of its collaboration agreement with Sanofi in 2023. Research and development expenses rose to $118.0 million from $68.9 million, and general and administrative expenses rose to $22.8 million from $13.2 million, driving a net loss of $116.0 million, or $0.70 per share, versus a net loss of $68.1 million in the first quarter of 2023. Cash, cash equivalents and marketable securities totaled $1.70 billion as of March 31, 2024, down from $1.85 billion at December 31, 2023. The company's near-term focus is advancing its lead RAS(ON) multi-selective inhibitor RMC-6236 into randomized, controlled monotherapy pivotal trials, starting with second-line pancreatic ductal adenocarcinoma (PDAC) and followed by second-line non-small cell lung cancer (NSCLC). Management expects to disclose updated monotherapy data in the second half of 2024 to support initiating both pivotal studies that year. The company also plans further data releases in the second half of 2024 for RMC-6236 plus pembrolizumab and for RMC-9805 monotherapy, and expects initial RMC-6291 plus pembrolizumab data in the first half of 2025. For full-year 2024, the company reiterated its projected GAAP net loss of between $480 million and $520 million, including estimated non-cash stock-based compensation of $70 million to $80 million. Based on its current operating plan, the company projects that its existing cash, cash equivalents and marketable securities can fund planned operations into 2027.
Revolution Medicines Quarterly Report for Q1 Ended Mar 31, 2024
Revolution Medicines, Inc. reported its first-quarter 2024 results in this Form 10-Q for the period ended March 31, 2024. The company is a clinical-stage precision oncology company developing targeted therapies for RAS-addicted cancers. It reported no revenue for the quarter, compared with $7.0 million of collaboration revenue in the year-earlier period, after the Sanofi collaboration terminated in June 2023. Research and development expense rose to $118.0 million from $68.9 million, and general and administrative expense rose to $22.8 million from $13.2 million, producing a net loss of $116.0 million, or $0.70 per share, versus $68.1 million, or $0.72 per share, a year earlier. Interest income of $23.8 million partly offset the operating loss. The balance sheet shows cash, cash equivalents and marketable securities of $1.7 billion at March 31, 2024, with an accumulated deficit of $1.3 billion. Management states that existing cash and marketable securities will fund planned operations for at least 12 months following the filing. The November 2023 acquisition of EQRx, Inc. added approximately $1.1 billion in net cash, cash equivalents and marketable securities, and the company issued 54.8 million shares in that transaction. Net cash used in operating activities was $160.6 million for the quarter. The filing focuses on the RMC-6236, RMC-6291 and RMC-9805 RAS(ON) inhibitor programs. Management expects to disclose updated monotherapy data for RMC-6236 in PDAC and NSCLC, and to initiate planned registrational trials, in the second half of 2024. The filing also notes that the company has not yet obtained regulatory approval for any product candidate and has no products approved for commercial sale.
Revolution Medicines Annual Report, Year Ended Dec 31, 2023
Revolution Medicines, Inc. (RVMD) is a clinical-stage precision oncology company developing RAS(ON) inhibitors for RAS-addicted cancers. It has no approved products and has never generated product revenue. The company reported a net loss of $436.4 million for 2023, compared with $248.7 million in 2022, and an accumulated deficit of $1,137.7 million at December 31, 2023. Collaboration revenue fell to $11.6 million from $35.4 million as the Sanofi SHP2 agreement terminated in June 2023. Research and development expense rose to $423.1 million and general and administrative expense to $75.6 million. The November 9, 2023 acquisition of EQRx, Inc. was all-stock, with 54.8 million shares issued. It was accounted for as a capital-raising transaction and added about $1.1 billion in net cash, cash equivalents and marketable securities. At December 31, 2023 the company held $1.9 billion in cash, cash equivalents and marketable securities, and management believes this will fund planned operations for at least 12 months after the report date. The lead programs are RMC-6236, a RAS(ON) multi-selective inhibitor, and the mutant-selective inhibitors RMC-6291 (G12C) and RMC-9805 (G12D). The company plans two monotherapy registration studies, in second-line NSCLC and PDAC, subject to regulatory input, and expects several clinical data updates in the second half of 2024. Results to date are early, drawn from Phase 1 studies with limited patient numbers, and the filing stresses that these interim results may not predict later outcomes.
Revolution Medicines 8-K Report, Financial Results (Feb 26, 2024)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the quarter and year ended December 31, 2023, and provided an update on corporate progress in a press release furnished as Exhibit 99.1. For the full year 2023, total revenue was $11.6 million, compared to $35.4 million in 2022, reflecting the termination of the collaboration agreement with Sanofi in 2023. Research and development expenses were $423.1 million and general and administrative expenses were $75.6 million, resulting in a full-year net loss of $436.4 million, compared to $248.7 million in 2022. Cash, cash equivalents and marketable securities were $1.85 billion at year-end, up from $644.9 million a year earlier, driven by the November 2023 acquisition of EQRx and a March 2023 public equity offering. The company's 2024 strategy centers on its RAS(ON) inhibitors. Management plans to advance RMC-6236 into monotherapy pivotal trials in second-line non-small cell lung cancer and second-line pancreatic ductal carcinoma, with studies expected to begin in the second half of 2024. The company also expects to disclose updated clinical data for RMC-6236 in the second half of 2024, and initial clinical data from the RMC-6291 and RMC-9805 programs, as well as RMC-6236 expansion cohorts, in 2024. For 2024, the company guided to a GAAP net loss between $480 million and $520 million, including estimated non-cash stock-based compensation of $70 million to $80 million, and stated that current cash, cash equivalents and marketable securities can fund planned operations into 2027. The press release notes that EQRx wind-down costs were $26.9 million in the fourth quarter and full year 2023 and that wind-down activities are nearing completion. Management described the 2023 year as transformative and stated that RMC-6236 and RMC-6291 showed clinically meaningful antitumor responses as single agents at generally safe and well-tolerated doses.
Revolution Medicines 8-K Report, Financial Results (Jan 9, 2024)
Revolution Medicines, Inc. (RVMD) filed this Form 8-K on January 9, 2024 to furnish a corporate presentation, posted that day to its investor website, under Item 2.02 (Results of Operations and Financial Condition) and Item 7.01 (Regulation FD Disclosure). The information is furnished rather than filed, so it is not subject to Section 18 liabilities or incorporated by reference into other SEC filings. The presentation, Exhibit 99.1, is titled "On Target to Outsmart Cancer" and centers on the company's RAS(ON) inhibitor pipeline: RMC-6236 (a multi-selective inhibitor), RMC-6291 (a G12C-selective inhibitor) and RMC-9805 (a G12D-selective inhibitor), along with 2024 priorities to propel RMC-6236 into pivotal trials and advance mutant-selective inhibitors toward late-stage development. The presentation reports early Phase 1 data. For RMC-6236 in KRAS G12X NSCLC (evaluable n=40), the objective response rate was 38% (15 responses, 12 confirmed) and the disease control rate was 85%. In KRAS G12X PDAC (evaluable n=46), the objective response rate was 20% and the disease control rate was 87%. For RMC-6291 in previously treated or naive KRAS G12C NSCLC, the objective response rate was 50% in the G12C-inhibitor-naive group (n=10) and 43% in the prior-G12C-inhibitor group (n=7). In CRC, the objective response rate was 40% (n=19 evaluable). The company stated that it projects its cash, cash equivalents and marketable securities, a preliminary estimate of $1.85 billion as of December 31, 2023 (unaudited), can fund planned operations into 2027. It also guided to a 2023 net loss of $385 million to $415 million, excluding the impact of the EQRx acquisition, which the company said it could not quantify without unreasonable effort. The presentation also outlines planned global randomized Phase 3 trials of RMC-6236 in previously treated RAS-mutant NSCLC (study initiation aimed for 2024) and in previously treated PDAC (potentially initiated in 2024). The filing notes that the presentation's forward-looking statements carry risk and that the company has not yet completed its year-end financial close.
Revolution Medicines 8-K/A Report, Exhibit Filing (Dec 26, 2023)
Revolution Medicines, Inc. filed this Amendment No. 1 to its Form 8-K to supply the unaudited pro forma condensed combined financial information for its acquisition of EQRx, Inc., which was completed on November 9, 2023 under a Merger Agreement dated July 31, 2023. The filing states that the transaction is accounted for as a capital-raising transaction with an asset acquisition component, because EQRx's assets were primarily cash, cash equivalents and marketable securities and EQRx had wound down most of its research and development and operations. Revolution Medicines issued approximately 54.8 million shares of common stock to EQRx stockholders, and the estimated purchase price was $1,086.4 million, based on a share price of $20.02 as of November 9, 2023. On a pro forma basis as of September 30, 2023, combined cash and cash equivalents were $660.0 million, marketable securities were $1,351.4 million, and total assets were $2.20 billion. Pro forma stockholders' equity was $1.97 billion. For the nine months ended September 30, 2023, the pro forma net loss was $513.0 million ($3.24 per share), compared with Revolution Medicines' historical net loss of $274.8 million. For the year ended December 31, 2022, the pro forma net loss was $443.4 million ($3.27 per share). The filing notes that the figures are preliminary, subject to change, and illustrative only, and that the purchase price allocation may differ materially once finalized. The pro forma results include a one-time post-combination compensation charge of $13.8 million tied to accelerated vesting of EQRx equity awards, and $11.8 million of expected severance related to terminations of EQRx employees. Expected transaction costs of $14.0 million were charged against cash and additional paid-in capital.
Revolution Medicines 8-K Report, Acquisition Completed (Nov 9, 2023)
On November 9, 2023, Revolution Medicines, Inc. (RVMD) completed its mergers with EQRx, Inc. Under the Merger Agreement dated July 31, 2023, each share of EQRx common stock was converted into the right to receive 0.1112 of a share of Revolution Medicines common stock, with cash paid in lieu of fractional shares based on a $21.18 closing price on November 8, 2023. EQRx options that were in the money were cancelled and converted into Revolution Medicines stock based on the exchange ratio, out-of-the-money options were terminated for no consideration, restricted stock units were converted on the same basis, and EQRx warrants were assumed by Revolution Medicines and became exercisable for the merger consideration. Stockholders of Revolution Medicines approved the share issuance proposal at a special meeting held November 8, 2023, with 85,738,003 votes for, 9,442,157 against, and 123,934 abstentions out of 95,304,094 shares present or represented. Sandra J. Horning, M.D., was appointed to the Revolution Medicines board as the EQRx designee and is a Class II director with a term expiring at the 2025 annual meeting. EQRx has ceased to exist as a separate legal entity, its common stock and publicly traded warrants are being delisted from Nasdaq, and EQRx, LLC, as successor, intends to file Form 15 to deregister. The filing also incorporates EQRx's audited 2022 and 2021 financial statements and unaudited nine-month 2023 financial statements by reference, and states that Revolution Medicines will file pro forma financial statements by amendment later.
Revolution Medicines 8-K Report, Financial Results (Nov 6, 2023)
Revolution Medicines, Inc. (Nasdaq: RVMD) reported financial results for the quarter ended September 30, 2023, and provided an update on corporate progress, as furnished in Exhibit 99.1 to this Current Report on Form 8-K. The company reported no collaboration revenue for the quarter, compared with $3.4 million in the prior-year quarter. Research and development expenses rose to $107.7 million from $69.5 million, and general and administrative expenses rose to $15.5 million from $10.4 million. Net loss was $108.4 million, compared with $73.3 million a year earlier. Cash, cash equivalents and marketable securities totaled $813.2 million as of September 30, 2023. The company highlighted clinical data for its investigational RAS(ON) Inhibitors. RMC-6236, a RASMULTI(ON) Inhibitor, showed anti-tumor activity in patients with NSCLC or PDAC harboring KRASG12X mutations, and the company decided to advance it into late-stage development, with a Phase 3 study in previously treated RAS-mutated NSCLC expected to start in 2024. RMC-6291, a RASG12C(ON) Inhibitor, showed preliminary anti-tumor activity in KRASG12C-mutant solid tumors. The company also noted that its stockholders' vote on the all-stock acquisition of EQRx, Inc. was scheduled for November 8, 2023, with closing expected shortly after. The company estimates the deal would add approximately $1.1 billion in net cash proceeds and issue about 55 million shares. For full year 2023, the company updated its projected GAAP net loss to between $385 million and $415 million, excluding the financial impact of the EQRx transaction. It projects that current cash, cash equivalents and investments can fund planned operations into 2025.
Revolution Medicines Quarterly Report for Q3 Ended Sep 30, 2023
Revolution Medicines, Inc. reported its quarterly results for the period ended September 30, 2023 in this Form 10-Q. The company is a clinical-stage precision oncology company focused on targeted therapies for RAS-addicted cancers. It reported no collaboration revenue for the three months ended September 30, 2023, compared with $3.4 million in the prior-year period, as the Sanofi Agreement terminated in June 2023. Net loss was $108.4 million for the quarter ($0.99 per share) versus $73.3 million a year earlier, and $274.8 million for the nine months. Research and development expense rose to $107.7 million for the quarter, driven mainly by RMC-6236 clinical costs. Cash, cash equivalents and marketable securities totaled $813.2 million at September 30, 2023, and management believes these fund planned operations for at least 12 months. The company entered into an all-stock Agreement and Plan of Merger with EQRx, Inc. on July 31, 2023. Under the terms, EQRx stockholders would receive shares based on 7,692,308 shares plus $870.0 million divided by a price at a 6% discount to the 5-day VWAP, and the filing states the transaction is anticipated to close in November 2023, subject to stockholder approvals. The filing states the company expects to issue approximately 55 million shares in connection with closing, and that the transaction will result in substantial dilution to existing stockholders. The filing highlights ongoing clinical development of RMC-6236, RMC-6291 and RMC-9805, with the company planning global Phase 3 trials for RMC-6236 in previously treated RAS-mutated NSCLC and potentially in PDAC. The company's accumulated deficit was $976.2 million as of September 30, 2023.
Revolution Medicines 8-K Report, Regulation FD Disclosure (Nov 1, 2023)
Revolution Medicines, Inc. (RVMD) filed this Form 8-K on November 1, 2023 to report the final exchange ratio for its proposed acquisition of EQRx, Inc. Under the Merger Agreement dated July 31, 2023, each share of EQRx common stock will convert into the right to receive 0.1112 of a share of Revolution Medicines common stock, with cash paid in lieu of fractional shares. The filing states this ratio is higher than the assumed 0.0734 ratio illustrated in the joint proxy statement/prospectus dated September 29, 2023. If the Mergers are completed, Revolution Medicines expects to issue approximately 55 million shares (excluding warrants and earn-out shares). The company estimates the Mergers will add approximately $1.1 billion in net cash proceeds, after estimated post-closing EQRx wind-down and transition costs, or approximately $20 per share of Revolution Medicines common stock issued in the transaction. The company also stated that it expects not to advance EQRx's research and development portfolio after closing, and that EQRx expects to wind down its programs. The filing's accompanying press release (Exhibit 99.1) reports that proxy advisory firms ISS and Glass Lewis recommend that Revolution Medicines stockholders vote "FOR" the share issuance at a special meeting scheduled for November 8, 2023. The transaction is expected to close in November 2023, subject to customary conditions, including approval by both companies' stockholders.
Revolution Medicines 8-K Report, Regulation FD Disclosure (Oct 23, 2023)
On October 22, 2023, Revolution Medicines, Inc. furnished an updated corporate presentation (Exhibit 99.1) and reported updated preliminary safety and anti-tumor data for its lead RAS(ON) inhibitor RMC-6236 in its Phase 1/1b RMC-6236-001 trial. As of an October 12, 2023 data cut-off, 111 patients with NSCLC (n=46) or PDAC (n=65) were evaluated across six dose cohorts from 80 mg to 400 mg daily. The company described an acceptable safety profile, with rash and gastrointestinal toxicities as the most common treatment-related adverse events, primarily Grade 1 or 2. No fatal treatment-related adverse events were observed, and no signals of elevated hepatotoxicity risk were seen. Among efficacy-evaluable patients, the objective response rate was 38% in NSCLC (15 of 40, with one complete response) and 20% in PDAC (9 of 46 partial responses), with disease control rates of 85% and 87%, respectively. The company also outlined development plans: a planned global randomized Phase 3 trial of RMC-6236 versus docetaxel in previously treated RAS-mutated NSCLC, aiming to start in 2024, and a potential Phase 3 in PDAC with a start potentially in 2024, both subject to regulatory feedback. Planning is underway for combination pivotal trials. Separately, the company concluded that its RMC-4630 combined with sotorasib showed additive side effects and insufficient tolerability to confer clinical benefit, and it has no immediate plans for further development of RMC-4630. The presentation also referenced a pending all-stock acquisition of EQRx, with a shareholder vote scheduled for November 8, 2023, and cash, cash equivalents and marketable securities of $909.5 million as of June 30, 2023, with planned operations funded into 2025.
Revolution Medicines 8-K Report, Corporate Update (Oct 13, 2023)
On October 13, 2023, Revolution Medicines, Inc. filed an Item 8.01 (Other Events) report providing pipeline updates across three programs: RMC-6236 (RASMULTI(ON) inhibitor), RMC-6291 (RASG12C(ON) inhibitor), and RMC-5127, which the Company has selected as a development candidate. The filing states that RMC-6236 showed an acceptable, generally well-tolerated safety profile across 131 evaluable patients in nine dose cohorts (10 mg to 400 mg daily) as of a September 11, 2023 data cut-off. The most common treatment-related adverse events were rash and gastrointestinal toxicities, mostly Grade 1 or 2. The company reported dose-dependent exposure, minimal accumulation consistent with once-daily dosing, and molecular responses in ctDNA across NSCLC and PDAC patients, plus three clinical case reports of tumor regression. For RMC-6291, as of an October 5, 2023 data cut-off, 63 evaluable patients across seven dose cohorts showed an acceptable safety profile. The most common treatment-related adverse events were QTc prolongation and GI toxicities, primarily Grade 1 or 2, and no treatment-related Grade 4 or 5 adverse events or serious adverse events were reported. Among 17 efficacy-evaluable patients with KRASG12C-mutant NSCLC, the best overall response rate was 50% in patients previously treated with a KRASG12C(OFF) inhibitor (10 patients) and 43% in treatment-naive patients (7 patients). Among 20 treatment-naive KRASG12C-mutant CRC patients, the objective response rate was 40%. The company believes these data provide preliminary evidence of differentiation from KRASG12C(OFF) inhibitors. The filing is a pipeline update based on early-stage data, and it includes standard forward-looking statement risk disclosures referencing the Company's Form 10-Q filed August 8, 2023.
Revolution Medicines 8-K Report, Executive Changes (Sep 5, 2023)
Revolution Medicines, Inc. (RVMD) filed this Current Report on Form 8-K under Item 5.02 to disclose board and committee changes. On August 31, 2023, Eric T. Schmidt, Ph.D., resigned from the Board of Directors effective September 5, 2023, to accept a position as an investment analyst. The filing states that his resignation was not the result of any disagreement with the Company or any matter relating to its operations, policies or practices. Following Dr. Schmidt's departure from the Board and the Audit Committee, the Board appointed Lorence Kim, M.D., a current Audit Committee member, as Chair of the Audit Committee. The Board also appointed Alexis Borisy to the Audit Committee to fill the resulting vacancy. The filing contains no financial results, operating metrics, or financial figures. Its significance for investors is limited to governance changes affecting the Board and the composition and leadership of the Audit Committee.
Revolution Medicines 8-K Report, Financial Results (Aug 8, 2023)
Revolution Medicines, Inc. reported its financial results for the quarter ended June 30, 2023, with total revenue of $3.8 million, compared to $9.1 million for the quarter ended June 30, 2022, consisting of revenue from its collaboration agreement with Sanofi. Research and development expenses rose to $98.0 million from $61.0 million, and general and administrative expenses rose to $14.6 million from $10.2 million, resulting in a net loss of $98.3 million for the quarter, compared to a net loss of $61.2 million a year earlier. Cash, cash equivalents and marketable securities totaled $909.5 million as of June 30, 2023, up from $644.9 million at December 31, 2022, primarily due to the company's public equity offering in March 2023. The company reiterated its full-year 2023 GAAP net loss guidance of $360 million to $400 million, including estimated non-cash stock-based compensation expense of $40 million to $50 million, and stated that its current cash, cash equivalents and investments can fund planned operations into 2025. This guidance excludes the proposed EQRx transaction. On August 1, 2023, the company announced a definitive agreement to acquire EQRx, Inc. in an all-stock transaction intended to add more than $1 billion in net cash to its balance sheet, with closing expected in November 2023, subject to regulatory review and stockholder approvals. On the clinical side, the company highlighted RMC-6236, its RAS(ON) Inhibitor, with an update on antitumor activity in non-small cell lung cancer and pancreatic cancer to be presented as an oral presentation at ESMO 2023 and supporting data at the Triple Meeting in October 2023. Planning is underway for one or more single-agent pivotal trials potentially beginning in 2024, and a Phase 1/1b combination trial of RMC-6236 and RMC-6291 is planned to potentially begin in early 2024. The company also expects to announce dosing of the first patient in its RMC-9805 (KRASG12D) study in the second half of 2023.