RVMDW — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-11-04

• RASONQUE is the first approved medicine from a new class of RAS(ON) multi-selective and mutant-selective inhibitors. In August 2026, the FDA approved RASONQUE for the treatment of adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are…

• RASONQUE is a multi-selective inhibitor designed as an oral, tri-complex inhibitor of multiple RAS(ON) variants containing cancer driver mutations at all three of the major RAS mutation hotspot positions, G12, G13, and Q61. RASONQUE inhibits all three major RAS isoforms, suppressing the mutant cance…

• Zoldonrasib is designed as an oral RAS(ON) G12D-selective tri-complex inhibitor. It is designed to exhibit low nanomolar potency for suppressing RAS pathway signaling and growth of RAS G12D-bearing cancer cells and is engineered to covalently inactivate RAS G12D irreversibly. Zoldonrasib has receive…

• G12C over wild-type RAS and other cellular targets. Elironrasib is designed to be differentiated from first-generation KRAS(OFF) G12C inhibitors, which sequester the KRAS(OFF) G12C form, by its mechanism of directly inhibiting the RAS(ON) G12C form. Elironrasib has received Breakthrough Therapy Desi…

• RMC-5127 is designed as an oral RAS(ON) G12V-selective tri-complex inhibitor. It is designed to exhibit picomolar potency for suppressing RAS pathway signaling and growth of RAS G12V-bearing cancer cells and is engineered for selective inhibition of RAS G12V over other RAS isoforms via non-covalent …

Text removed vs the prior filing · source: 10-Q · 2026-08-05

• Daraxonrasib, our RAS(ON) multi-selective inhibitor, is designed as an oral, tri-complex inhibitor of multiple RAS(ON) variants containing cancer driver mutations at all three of the major RAS mutation hotspot positions, G12, G13, and Q61. Daraxonrasib inhibits all three major RAS isoforms, suppress…

• Zoldonrasib is designed as an oral RAS(ON) G12D-selective tri-complex inhibitor. It is designed to exhibit low nanomolar potency for suppressing RAS pathway signaling and growth of RAS G12D-bearing cancer cells and is engineered to covalently inactivate RAS G12D irreversibly. Zoldonrasib has receive…

• Elironrasib is designed as an oral RAS(ON) G12C-selective tri-complex inhibitor. It is designed to exhibit subnanomolar potency for suppressing RAS pathway signaling and growth of RAS G12C-bearing cancer cells and is engineered to be highly selective for RAS G12C over wild-type RAS and other cellula…

• ongoing. We currently expect to identify a recommended Phase 2 dose for RMC-5127 during the second half of 2026 and to share initial clinical data in 2027.

• We have designed a new class of tri-complex RAS(ON) Inhibitors in order to overcome RAS-driven drug resistance and thereby extend the clinical benefit of RAS(ON) Inhibitors. We currently expect to initiate a first-in-human clinical trial from this class of RAS(ON) Inhibitors in the fourth quarter of…

Text added vs the prior filing · source: 10-Q · 2026-11-04

• We are exposed to interest rate risk on floating-rate borrowings that we incur under our Term Loan Facility, which bear interest at three-month term SOFR, subject to a floor of 3.5%, plus 5.75%. A hypothetical 100 basis point increase in three-month term SOFR would increase our annual interest expen…

• Our expenses are generally denominated in U.S. dollars. However, we have entered into a limited number of contracts with vendors for services with payments denominated in foreign currencies, including the Euro, British Pound, Japanese Yen, Swiss Francs and Chinese Yuan. We are subject to foreign cur…

Text removed vs the prior filing · source: 10-Q · 2026-08-05

• Our expenses are generally denominated in U.S. dollars. However, we have entered into a limited number of contracts with vendors for research and development services with payments denominated in foreign currencies, including the Euro, British Pound and Chinese Yuan. We are subject to foreign curren…

Text added vs the prior filing · source: 10-Q · 2026-11-04

• In connection with the commercial launch of RASONQUE in August 2026, we implemented new processes and internal controls over financial reporting relating to revenue recognition, including the estimation of variable consideration; order-to-cash, including customer onboarding, order processing, shippi…

Text removed vs the prior filing · source: 10-Q · 2026-08-05

• There were no changes in our internal controls over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three and six months ended June 30, 2026 that have materially affected, or are reasonably likely…

Text added vs the prior filing · source: 10-Q · 2026-11-04

• accurately estimating the rebates, chargebacks, discounts, returns and other deductions that reduce our gross product revenue, and managing the level of those deductions;

• maintaining adequate commercial supply of RASONQUE to meet demand while avoiding excess or obsolete inventory;

• exposing us to increases in interest rates, because borrowings under the Term Loan Facility bear interest at a floating rate subject to a floor, such that our interest expense may increase but will not decline below a minimum level;

• subjecting substantially all of our assets, including our intellectual property, to a lien in favor of our lender, which could be foreclosed upon following an event of default;

• Because we drew the first tranche under the Loan Agreement in October 2026, we are now subject to these covenants with respect to $250.0 million of outstanding secured indebtedness, and the collateral securing that indebtedness includes substantially all of our assets, including our intellectual pro…

Text removed vs the prior filing · source: 10-Q · 2026-08-05

• funds for our current or future operating plans. See “Item 2. Management’s Discussion and Analysis—Liquidity and Capital Resources” for additional information.

• obligations. Compliance with these covenants may limit our flexibility in operating our business and our ability to take actions that might otherwise be advantageous to us and our stockholders.

• the conversion rate. In either case, and in other cases, our obligations under the 2033 Notes and the indenture governing the 2033 Notes could increase the cost of acquiring us or otherwise discourage a third party from acquiring us, including in a transaction that holders of the 2033 Notes or holde…

• We have only recently completed our first NDA submission to the FDA, which has been accepted for review, and have not previously submitted similar applications to any comparable foreign regulatory authority, for any product candidate. An NDA or other relevant regulatory application must include exte…

• We plan to seek regulatory approval to commercialize our product candidates both in the United States and in select foreign countries, alone or in collaboration. While the scope of regulatory approval generally is similar in other countries, in order to obtain separate regulatory approval in other c…

Text added vs the prior filing · source: 10-Q · 2026-11-04

• On June 23, 2026, Elizabeth Anderson, a member of our board of directors, adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) promulgated under the Exchange Act, which provides for the potential exercise and sale of up to 30,163 shares of our c…

• On August 12, 2026, Jack Anders, our Chief Financial Officer, adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) promulgated under the Exchange Act, which provides for the potential exercise and sale of up to 71,500 shares of our common stock …

• On August 17, 2026, Steve Kelsey, M.D., FRCP, FRCPath, who served as our President, Research and Development until June 30, 2026 and currently serves as Senior Advisor to the Chief Executive Officer, adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule 10…

• On August 20, 2026, Flavia Borellini, a member of our board of directors, adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) promulgated under the Exchange Act, which provides for the potential sale of up to 14,624 shares of our common stock h…

Text removed vs the prior filing · source: 10-Q · 2026-08-05

• On May 22, 2026, Mark A. Goldsmith, M.D., Ph.D., our President and Chief Executive Officer and Chair of the Board of Directors, adopted a Rule 10b5-1 trading plan. Dr. Goldsmith’s Rule 10b5-1 trading plan is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) promulgated under t…

• On May 22, 2026, Jeff Cislini, Senior Vice President, General Counsel and Secretary, adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) promulgated under the Exchange Act, which provides for (i) the potential exercise and sale of up to 78,966 …

• On June 11, 2026, Anthony Mancini, our Chief Global Commercialization Officer, adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) promulgated under the Exchange Act, which provides for (i) the potential

• exercise and sale of up to 24,968 shares of our common stock subject to stock options held by Mr. Mancini and (ii) the potential sale of shares of our common stock issued upon the settlement of 18,950 restricted stock units, less the number of shares sold to cover tax withholding obligations in conn…

• On June 14, 2026, Alan Sandler, M.D., our Chief Development Officer, adopted a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) promulgated under the Exchange Act. Dr. Sandler’s trading arrangement covers the sale of the number of shares of our…