Revolution Medicines, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
RVMD$192.28+8.2%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001193125-26-335104
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001193125-26-447253
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 625 previous paragraphs and 642 current paragraphs.
451 unchanged; 158 reworded; 31 added; 12 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (31)
Current report
accurately estimating the rebates, chargebacks, discounts, returns and other deductions that reduce our gross product revenue, and managing the level of those deductions;
Current report
maintaining adequate commercial supply of RASONQUE to meet demand while avoiding excess or obsolete inventory;
Current report
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;
Current report
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;
Current report
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 property. Now that we have commenced commercial sales of RASONQUE, Royalty Pharma is entitled to receive tiered royalty payments on net sales, which reduces the cash we retain from sales of RASONQUE. In addition, the Royalty Purchase Agreement provides for an upward adjustment to the royalty rates in the years from 2030 through 2041 if annual net sales in the prior year fall below an agreed-upon threshold, which means that slower-than-expected sales growth would increase the proportion of net sales payable to Royalty Pharma.
Current report
the level of demand for RASONQUE, which may vary significantly from period to period and may not be reflected in our reported net product revenue in any given period due to changes in inventory levels in the distribution channel;
Current report
the amount of rebates, chargebacks, discounts, returns and other deductions that reduce our gross product revenue, and changes in our estimates of those deductions;
Current report
the cost basis of RASONQUE inventory sold, including the effect of selling inventory that was expensed as research and development prior to FDA approval and therefore carries no cost basis;
Current report
changes in interest expense, including as a result of changes in the floating rate applicable to borrowings under the Term Loan Facility and changes in our estimates of future royalty payments under the Royalty Purchase Agreement, which affect the effective interest rate used to measure that liability;
Current report
the commercial availability of RASONQUE, which may reduce the willingness of patients and physicians to enroll in clinical trials in which the patient may receive a comparator therapy rather than RASONQUE; and
Current report
Because RASONQUE is approved and commercially available, physicians may prescribe RASONQUE in combination with other therapies in regimens that have not been approved and for which safety and efficacy have not been established. We are not permitted to promote RASONQUE for any such unapproved combination, and adverse events arising from such use could result in label changes, regulatory action or product liability claims, notwithstanding that the combination was not one we promoted.
Current report
In addition, we supply RASONQUE for use in trials sponsored by our collaborators. We may have limited control over the conduct of those trials, including protocol compliance, safety reporting and the accuracy of data generated, and deficiencies in a collaborator-sponsored trial involving RASONQUE could adversely affect RASONQUE's label or our regulatory standing.
Current report
Our competitors include companies with substantially greater commercial infrastructure, established relationships with prescribers, payors and specialty pharmacies, and greater experience in securing formulary access and favorable reimbursement. These advantages may allow them to compete effectively against RASONQUE even if their products are not clinically superior. In addition, RASONQUE may face competition from generic versions following the expiration or successful challenge of our patents and regulatory exclusivities. See the risk factors under “Risks related to our intellectual property.”
Current report
This lengthy and uncertain approval process, as well as the unpredictability of clinical and preclinical studies, may result in our failure to obtain regulatory approval to market any of our product candidates, or delayed regulatory approval.
Current report
we may be required to conduct additional post-marketing studies or clinical trials, or to modify the design or conduct of our ongoing trials;
Current report
third-party payors may restrict coverage or impose utilization management requirements;
Current report
In addition, we may promote RASONQUE only for its approved indication and consistent with its approved labeling. The FDA and state authorities closely regulate promotional materials, sales representative communications, speaker programs, scientific exchange and interactions with prescribers. If the FDA determines that our promotional activities constitute off-label promotion or are false or misleading, we could be subject to untitled or warning letters, corrective advertising requirements, consent decrees, civil penalties or criminal prosecution, and off-label promotion allegations have formed the basis for substantial False Claims Act liability in our industry.
Current report
the scope of the approved indication and any limitations or restrictions in the product labeling, including the approved line of therapy, patient population and dosing regimen;
Current report
the adequacy of our commercial infrastructure, including the size and effectiveness of our field force and our market access and patient support capabilities;
Current report
the time required to obtain prior authorization and to initiate therapy, and the rate at which prescriptions written are ultimately filled;
Current report
The FDA did not require approval or clearance of a companion diagnostic in connection with the approval of RASONQUE, and RASONQUE is not limited to patients with an identified RAS mutation.
Current report
In October 2025, the FDA included RASONQUE in its initial group of CNPV recipients and on August 26, 2026, the FDA approved RASONQUE for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
Current report
the need to add warnings or precautions to the RASONQUE label or to implement a REMS or other risk mitigation measures;
Current report
We rely on third parties to manufacture our products and product candidates and are subject to a multitude of manufacturing risks, any of which could delay, prevent or impair our development or commercialization efforts.
Current report
We rely on third-party manufacturers for commercial supply of RASONQUE and intend to continue to do so for long-term commercial supply. Our commercial supply agreement obligates us to issue binding forecasts, and our forecasts of demand for RASONQUE are subject to significant uncertainty. If we overestimate demand, we may incur excess or obsolete inventory charges; if we underestimate demand, we may be unable to supply RASONQUE to patients.
Current report
In connection with the commercialization of RASONQUE, we operate or support patient assistance and support programs, including our (ON)Path patient support program, that provide benefits verification, prior authorization support, copay assistance for commercially insured patients, free product for eligible uninsured or underinsured patients, nursing and adherence support, and reimbursement support services, certain of which are administered by third-party vendors. These programs are subject to the federal Anti-Kickback Statute, the federal civil monetary penalty provisions described above, the False Claims Act and analogous state laws, and the Office of Inspector General has issued guidance addressing the circumstances under which manufacturer-sponsored patient assistance, copay support, reimbursement support and contributions to independent charitable foundations may implicate these laws. If any of these programs were found to provide remuneration that induces the purchase or prescription of RASONQUE, to be used to steer patients toward RASONQUE, or to result in the submission of claims to federal healthcare programs that are tainted by unlawful remuneration, we could be subject to substantial civil and criminal penalties, treble damages under the False Claims Act, exclusion from federal healthcare programs and a corporate integrity agreement. In addition, we have limited ability to control the conduct of the third-party vendors that administer certain of these programs, and their non-compliance could expose us to liability. If RASONQUE is approved in jurisdictions outside of the U.S. and we operate or support similar patient assistance and support programs in those jurisdictions, we will face similar risks under applicable foreign anti-kickback, anti-bribery, healthcare fraud and abuse, pricing and reimbursement, and other laws and regulations, which vary by jurisdiction and may be subject to differing interpretations. Our failure, or the failure of the third-party vendors that administer these programs on our behalf, to comply with these laws could result in significant penalties, sanctions and reputational harm.
Current report
managing our commercial operations, including our field force, market access, distribution and patient support functions, and the third-party vendors that support them, in compliance with applicable healthcare, promotional and privacy laws;
Current report
implementing and maintaining the financial reporting processes and internal controls required to account for product revenue, gross-to-net deductions, inventory and accounts receivable;
Current report
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 subject to a stock option held by Mr. Anders. The trading plan will terminate at the earlier of the execution of all trading orders pursuant to the plan or August 15, 2027.
Current report
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 held by Ms. Borellini. The trading plan will terminate at the earlier of the execution of all trading orders pursuant to the plan or November 17, 2027.
Current report
On September 9, 2026, Margaret Horn, J.D., our Chief Operating 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 96,775 shares of our common stock subject to a stock option held by Ms. Horn. The trading plan will terminate at the earlier of the execution of all trading orders pursuant to the plan or August 10, 2027.
Removed paragraphs (12)
Previous report
Further, while the FDA recently accepted our NDA for daraxonrasib for review, we cannot be certain that any of our programs will be successful in clinical trials or receive regulatory approval. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product candidates, we may not be able to continue our operations.
Previous report
From time to time, we may disclose interim data from our clinical trials. For example, we have reported interim Phase 1 single agent clinical data for daraxonrasib, elironrasib and zoldonrasib. In each case, this interim data included a limited number of patients and time of exposure to the study drug. Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more data on existing patients become available. When a clinical trial is ongoing, the final results from the trial may be materially different from those reflected in any interim data we report.
Previous report
Pricing and rebate calculations vary among products and programs. The calculations are complex and are often subject to interpretation by us, governmental or regulatory agencies, and the courts. CMS, the Department of Health & Human Services Office of Inspector General, and other governmental agencies have pursued manufacturers that were alleged to have failed to report these data to the government in a timely or accurate manner. Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. If we participate in these programs, we cannot assure you that any submissions we are required to make under the MDRP, the 340B program, the VA/FSS program, the Tricare Retail Pharmacy Program, and other governmental drug pricing programs will not be found to be incomplete or incorrect.
Previous report
It is possible that new laws and regulations will be adopted in the United States and in other non-U.S. jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to change the way we use AI Technologies in a manner that negatively affects the performance of our products, services, and business and the way in which we use AI Technologies. We may need to expend resources to adjust our products or services in certain jurisdictions if the laws, regulations, or decisions are not consistent across jurisdictions. Further, the cost to comply with such laws, regulations, or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI Technologies). Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition and results of operations.
Previous report
We rely on third parties to manufacture preclinical and clinical drug supplies, and we intend to rely on third parties to produce commercial supplies of any approved product, which increases the risk that we will not have sufficient quantities of these product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
Previous report
We intend to use third-party manufacturers for long-term commercial supply. Reliance on third-party manufacturers entails risks,
Previous report
regulatory or legal developments in the United States and other countries;
Previous report
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 the Exchange Act, and provides for (i) the potential exercise and sale of up to 150,000 shares of our common stock subject to a stock option held by Dr. Goldsmith, (ii) the potential sale of up to 12,000 shares of our common stock by a trust for which Dr. Goldsmith is a trustee and (iii) the potential sale of up to 12,000 shares of our common stock by another trust for which Dr. Goldsmith is a trustee. The trading plan will terminate at the earlier of the execution of all trading orders pursuant to the plan and September 30, 2027.
Previous report
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 shares of our common stock subject to stock options held by Mr. Cislini and (ii) the potential sale of shares of our common stock issued upon the settlement of 21,000 restricted stock units, less the number of shares sold to cover tax withholding obligations in connection with the vesting and settlement of such restricted stock units. The trading plan will terminate at the earlier of the execution of all trading orders pursuant to the plan and April 30, 2027.
Previous report
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 common stock required to be sold to cover tax withholding obligations for restricted stock unit awards that vest after June 15, 2026. The aggregate number of shares to be sold pursuant to this trading arrangement is dependent on the number of restricted stock unit awards that may be granted to Dr. Sandler from time to time and the taxes on these restricted stock unit awards, and, therefore, is indeterminable at this time.
Previous report
On June 15, 2026, Anthony Mancini, our Chief Global Commercialization 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. Mr. Mancini’s trading arrangement covers the sale of the number of shares of our common stock required to be sold to cover tax withholding obligations for restricted stock unit awards that vest after June 15, 2026. The aggregate number of shares to be sold pursuant to this trading arrangement is dependent on the number of restricted stock unit awards that may be granted to Mr. Mancini from time to time and the taxes on these restricted stock unit awards, and, therefore, is indeterminable at this time.
Reworded paragraphs (158)
Previous wording
We are a late-stage clinical oncology company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability, which, together with our limited operating history, makes it difficult to assess our future viability.
Current wording
We are a global, commercial-stage oncology company with a limited operating and commercial history and only one product approved for commercial sale pursuant to a single approved label. We have incurred significant losses since our inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability, which, together with our limited operating history, makes it difficult to assess our future viability.
Previous wording
We have never generated revenue from product sales and may never be profitable.
Current wording
We only recently began generating revenue from product sales and may never be profitable.
Previous wording
Our business is dependent on the successful development of our current and future product candidates. If we, alone or in collaboration, are unable to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any of our product candidates, or we experience significant delays in doing so, our business will be materially harmed.
Current wording
Our business is dependent on the successful commercialization and development of RASONQUE and our other current and future product candidates. If we, alone or in collaboration with third parties, are unable to successfully advance RASONQUE and our other current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize these products or product candidates, or we experience significant delays in doing so, our business will be materially harmed.
Previous wording
We are a late-stage clinical oncology company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability, which, together with our limited operating history, makes it difficult to assess our future viability.
Current wording
We are a global, commercial-stage oncology company with a limited operating and commercial history and only one product approved for commercial sale pursuant to a single approved label. We have incurred significant losses since our inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability, which, together with our limited operating history, makes it difficult to assess our future viability.
Previous wording
Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a late-stage clinical oncology company, and we have only a limited operating history upon which you can evaluate our business and prospects. We currently have no products approved for commercial sale, have not generated any revenue from sales of products and have incurred losses in each year since our inception in October 2014. In addition, we have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry.
Current wording
Biopharmaceutical product development and commercialization are highly speculative undertaking and involve a substantial degree of risk. We are a commercial-stage oncology company, and we have only a limited operating and commercial history upon which you can evaluate our business and prospects. We currently have only one product, RASONQUE, approved for commercial sale, have generated limited revenue from sales of RASONQUE, and have incurred losses in each year since our inception in October 2014. In addition, we have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry.
Previous wording
Since our inception, we have incurred significant net losses. Our net losses were $1.1 billion, $600.1 million and $436.4 million for the years ended December 31, 2025, 2024 and 2023, respectively. As of June 30, 2026, we had an accumulated deficit of $4.0 billion. We have funded our operations to date with proceeds from the sale of common stock and preferred stock, convertible senior notes, the acquisition of EQRx, and the Royalty Purchase Agreement. To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, acquiring and discovering development programs, securing intellectual property rights and conducting discovery, research and development activities for our programs. We have not yet demonstrated our ability to obtain marketing approvals, manufacture a commercial-scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Our product candidates will require additional development time and resources before we will be able to apply for or receive regulatory approvals and, if approved, begin generating revenue from product sales. We expect to continue to incur significant expenses and operating losses for the foreseeable future.
Current wording
Since our inception, we have incurred significant net losses. Our net losses were $1.1 billion, $600.1 million and $436.4 million for the years ended December 31, 2025, 2024 and 2023, respectively. As of September 30, 2026, we had an accumulated deficit of $4.4 billion. We have funded our operations to date with proceeds from the sale of common stock and preferred stock, convertible senior notes, the acquisition of EQRx and the Royalty Purchase Agreement. To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, acquiring and discovering development programs, securing intellectual property rights and conducting discovery, research and development activities for our programs. Although we have obtained FDA approval for RASONQUE and commercially launched it in the U.S. in August 2026, we have limited experience manufacturing a commercial-scale product, or arranging for a third party to do so on our behalf, or conducting sales and marketing activities necessary for successful product commercialization. Our other product candidates will require additional development time and resources before we will be able to apply for or receive regulatory approvals and, if approved, begin generating revenue from product sales. We expect to continue to incur significant expenses and operating losses for the foreseeable future.
Previous wording
We have never generated revenue from product sales and may never be profitable.
Current wording
We only recently began generating revenue from product sales and may never be profitable.
Previous wording
We have never generated revenue from product sales and our ability to generate future revenue from product sales and achieve profitability depends heavily on our, and any potential future collaborators’, success in:
Current wording
We only recently began generating revenue from product sales of RASONQUE, and our ability to grow future revenue from product sales and achieve profitability depends heavily on our, and any potential future collaborators’, success in:
Previous wording
launching and commercializing product candidates for which we obtain marketing approval by establishing a sales force, marketing, medical affairs and distribution infrastructure or, alternatively, collaborating with a commercialization partner;
Current wording
launching and commercializing RASONQUE and any other product candidates for which we obtain marketing approval by establishing a sales force, marketing, medical affairs and distribution infrastructure or, alternatively, collaborating with a commercialization partner;
Previous wording
achieving adequate coverage and reimbursement by third-party payors for our product candidates;
Current wording
achieving adequate coverage and reimbursement by third-party payors for RASONQUE and our product candidates;
Previous wording
establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services that are adequate in both amount and quality to support clinical development and market demand for our product candidates, if approved;
Current wording
establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services that are adequate in both amount and quality to support clinical development and market demand for RASONQUE and our product candidates, if approved;
Previous wording
obtaining market acceptance of our product candidates as viable treatment options, if approved;
Current wording
obtaining market acceptance of RASONQUE and our product candidates as viable treatment options, if approved;
Previous wording
Even if one or more of our product candidates is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate, including prior to a potential launch of any approved product candidate. Our expenses could increase beyond expectations if we are required by the FDA, the EMA or other regulatory agencies to perform clinical trials or studies in addition to those that we currently anticipate. Even if we are able to generate revenue from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.
Current wording
We anticipate incurring significant costs associated with commercializing RASONQUE and any other approved product candidate, including prior to a potential launch of any other approved product candidate. Our expenses could increase beyond expectations if we are required by the FDA, the EMA or other regulatory agencies to perform clinical trials or studies in addition to those that we currently anticipate. Even if we are able to generate revenue from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. In addition, our obligations under the Royalty Purchase Agreement entitle Royalty Pharma to a percentage of net sales of RASONQUE, and our Term Loan Facility requires us to pay interest at a floating rate, each of which reduces the cash we retain from product sales.
Previous wording
Building out commercial operations and additional clinical trials, preclinical studies and research and development activities will require substantial funds to complete. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $3.9 billion. In April 2026, we completed the Common Stock Offering and the Notes Offering, which together provided us with aggregate net proceeds of $2.1 billion. During the six months ended June 30, 2026, we sold an aggregate of 2,335,397 shares of common stock under the 2024 ATM and 2026 ATM resulting in net proceeds of $226.7 million. Further, additional capital may be available under the 2026 ATM and, subject to our meeting certain terms and conditions, including certain commercial milestones and other trigger events, additional capital may be available under the Loan Agreement and the Royalty Purchase Agreement (see “Notes to Unaudited Condensed Consolidated Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q for more information). We expect to continue to spend substantial amounts to continue the preclinical and clinical development of our current and future programs and to prepare for their potential commercialization. If we are able to gain marketing approval for our product candidates, we will require significant additional amounts of cash in order to launch and commercialize our product candidates, if approved, to the extent that their launch and commercialization are not the responsibility of another collaborator that we may contract with in the future. In addition, other unanticipated costs may arise. Because the design and outcome of our current, planned and potential future clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates.
Current wording
Building out commercial operations and additional clinical trials, preclinical studies and research and development activities will require substantial funds to complete. As of September 30, 2026, we had cash, cash equivalents and marketable securities of $3.7 billion. In October 2026, following FDA approval of RASONQUE, we drew the first tranche of $250.0 million under the Term Loan Facility, as required by the Loan Agreement. During the nine months ended September 30, 2026, we sold an aggregate of 2,950,997 shares of common stock under the 2024 ATM and 2026 ATM resulting in net proceeds of $352.6 million. Further, additional capital may be available under the 2026 ATM and, subject to our meeting certain terms and conditions, including certain commercial milestones and other trigger events, up to an additional $500.0 million may be available under the Loan Agreement and up to an additional $500.0 million under the Royalty Purchase Agreement (see “Notes to Unaudited Condensed Consolidated Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q for more information). We expect to continue to spend substantial amounts to continue the preclinical and clinical development of our current and future programs and to prepare for their potential commercialization. We expect to require significant additional amounts of cash to support the continued commercialization of RASONQUE, including sales, marketing, distribution, patient support and commercial supply costs, and to launch and commercialize any of our product candidates for which we obtain marketing approval, to the extent that their launch and commercialization are not the responsibility of a collaborator. In addition, other unanticipated costs may arise. Because the design and outcome of our current, planned and potential future clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates.
Previous wording
the timing, receipt and amount of sales of, profit share or royalties on, our product candidates, if approved;
Current wording
the timing, receipt and amount of sales of RASONQUE, sales of our product candidates if approved, and any profit share or royalties on, our product candidates, if approved;
Previous wording
Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under the 2033 Notes.
Current wording
Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under the 2033 Notes and the Term Loan Facility.
Previous wording
As of June 30, 2026, we had $500.0 million aggregate principal amount of indebtedness under the 2033 Notes and approximately $548.5 million of liabilities relating to our sale of future royalties pursuant to the Royalty Purchase Agreement. We may also incur additional indebtedness to meet future financing needs. Our indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:
Current wording
As of September 30, 2026, we had $500.0 million aggregate principal amount of indebtedness under the 2033 Notes and approximately $572.3 million of liabilities relating to our sale of future royalties pursuant to the Royalty Purchase Agreement. In addition, in October 2026, we borrowed $250.0 million of secured term loans under the Term Loan Facility. We may also incur additional indebtedness to meet future financing needs. Our indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:
Previous wording
Our business may not generate sufficient funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under our indebtedness, including the 2033 Notes, and our cash needs may increase in the future. In addition, our Loan Agreement contains, and any future indebtedness that we may incur may contain, financial and other restrictive covenants that limit our ability to operate our business, raise capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments under our indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in that and our other indebtedness becoming immediately payable in full.
Current wording
Our business may not generate sufficient funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under our indebtedness, including the 2033 Notes and the Term Loan Facility, and our cash needs may increase in the future. In addition, our Loan Agreement contains, and any future indebtedness that we may incur may contain, financial and other restrictive covenants that limit our ability to operate our business, raise capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments under our indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in that and our other indebtedness becoming immediately payable in full.
Previous wording
the timing of regulatory approvals, if any, in the United States and internationally;
Current wording
the timing of regulatory approvals, if any, in the U.S. and internationally;
Previous wording
coverage and reimbursement policies with respect to any future approved products, and potential future drugs that compete with our products;
Current wording
coverage and reimbursement policies with respect to RASONQUE and any future approved products, and potential future drugs that compete with our products;
Previous wording
the level of demand for any future approved products, which may vary significantly over time;
Current wording
the level of demand for RASONQUE and any future approved products, which may vary significantly over time;
Previous wording
Our business is dependent on the successful development of our current and future product candidates. If we are unable to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any of our product candidates, or we experience significant delays in doing so, our business will be materially harmed.
Current wording
Our business is dependent on the successful commercialization and development of RASONQUE and our other current and future product candidates. If we, alone or in collaboration with third parties, are unable to successfully commercialize RASONQUE and or other current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize these products or product candidates, or we experience significant delays in doing so, our business will be materially harmed.
Previous wording
Our business is dependent on the successful development of our current and future product candidates. We are evaluating certain of our product candidates in both exploratory and pivotal clinical trials, both as monotherapy and in combination regimens, across multiple types of cancer including the RASolute 302, RASolute 303, RASolute 304, RASolute 305, RASolve 301 and RASolve 308. Our other programs are in various stages of clinical and preclinical development, and the development of certain programs remains subject to our continuing assessment of portfolio priorities. The success of our business, including our ability to finance our company and generate revenue from products in the future, which may never occur, will depend heavily on the successful development and eventual commercialization of our product candidates. Our current and future product candidates require preclinical and clinical development, management of clinical, preclinical and manufacturing activities, marketing approval in the United States and other markets, demonstrating effectiveness to pricing and reimbursement authorities, obtaining sufficient manufacturing supply for both clinical development and commercial production, building of a commercial organization, and substantial investment and significant marketing efforts before we generate any revenues from product sales.
Current wording
Our business is dependent on the successful commercialization of RASONQUE and the successful development of our current and future product candidates. We are evaluating RASONQUE and certain of our product candidates in both exploratory and pivotal clinical trials, both as monotherapy and in combination regimens, across multiple types of cancer including RASolute 302, RASolute 303, RASolute 304, RASolute 305, RASolute 309, RASolve 301, RASolve 307 and RASolve 308. Our other programs are in various stages of clinical and preclinical development, and the development of certain programs remains subject to our continuing assessment of portfolio priorities. The success of our business, including our ability to finance our company and grow revenue from product sales, will depend heavily on the successful commercialization of RASONQUE and the successful development and eventual commercialization of our product candidates. Our current and future product candidates require preclinical and clinical development, management of clinical, preclinical and manufacturing activities, marketing approval in the U.S. and other markets, demonstrating effectiveness to pricing and reimbursement authorities, obtaining sufficient manufacturing supply for both clinical development and commercial production, building of a commercial organization, and substantial investment and significant marketing efforts before we generate any revenues from sales of such product candidates.
Previous wording
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 extensive preclinical and clinical data and supporting information to establish that the product candidate is safe and effective for each desired indication. The NDA or other relevant application must also include significant information regarding the chemistry, manufacturing and controls (CMC) for the product. We cannot be certain that our current or future product candidates will be successful in our ongoing clinical trials or receive regulatory approval. Further, even if they are successful in clinical trials, our product candidates or any future product candidates may not receive regulatory approval. For example, we may not receive regulatory approval of our NDA for daraxonrasib despite the positive topline readout of RASolute 302. If we do not receive regulatory approvals for current or future product candidates, our business would be materially harmed. Even if we successfully obtain regulatory approval to market a product candidate, our revenue will depend, in part, upon the size of the markets in the territories for which we or collaborators gain regulatory approval and have commercial rights, as well as the availability of competitive products, whether there is sufficient third-party reimbursement and adoption by physicians.
Current wording
Although the FDA has approved our NDA for RASONQUE, we have limited experience submitting NDAs and have only previously submitted one similar application to a comparable foreign regulatory authority, the CHMP, which began evaluating RASONQUE for the treatment of PDAC under a phased review process in July 2026 and adopted a positive opinion recommending marketing authorization for RASONQUE in the EU for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy in October 2026. An NDA or other relevant regulatory application must include extensive preclinical and clinical data and supporting information to establish that the product candidate is safe and effective for each desired indication. The NDA or other relevant application must also include significant information regarding the chemistry, manufacturing and controls (CMC) for the product. We cannot be certain that our current or future product candidates will be successful in our ongoing clinical trials or receive regulatory approval. Further, even if they are successful in clinical trials, our product candidates or any future product candidates may not receive regulatory approval. For example, we may not receive regulatory approval for RASONQUE in additional indications or lines of therapy, despite its approval for previously treated metastatic PDAC. If we do not receive regulatory approvals for current or future product candidates, our business would be materially harmed.
Previous wording
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 countries we must comply with numerous and varying regulatory requirements of such countries. Other countries also have their own regulations governing, among other things, clinical trials and commercial sales, as well as pricing and distribution of drugs, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictions.
Current wording
We plan to seek regulatory approval to commercialize our product candidates both in the U.S. 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 countries we must comply with numerous and varying regulatory requirements of such countries. Other countries also have their own regulations governing, among other things, clinical trials and commercial sales, as well as pricing and distribution of drugs, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictions.
Previous wording
The success of our current and future product candidates will depend on several factors, including the following:
Current wording
The success of RASONQUE and our current and future product candidates will depend on several factors, including the following:
Previous wording
establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if one of our product candidates is approved;
Current wording
establishing and maintaining agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, including for RASONQUE;
Previous wording
obtaining and maintaining regulatory exclusivity for our product candidates;
Current wording
obtaining and maintaining regulatory exclusivity for RASONQUE and our product candidates;
Previous wording
successfully launching commercial sales of our product candidates, if approved;
Current wording
successfully commercializing RASONQUE and launching commercial sales of our product candidates, if approved;
Previous wording
acceptance of the product candidate’s benefits and uses, if approved, by patients, the medical community and third-party payors;
Current wording
acceptance of the benefits and uses of RASONQUE and our product candidates, if approved, by patients, the medical community and third-party payors;
Previous wording
the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates prior to or following any approval;
Current wording
the prevalence, duration and severity of potential side effects or other safety issues experienced with RASONQUE or our product candidates prior to or following any approval;
Previous wording
If we or our collaborators are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our current or future product candidates, which would materially harm our business. If we or our collaborators do not receive marketing approvals for any of our product candidates, we may not be able to continue our operations.
Current wording
If we or our collaborators are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize RASONQUE or our current or future product candidates, which would materially harm our business. If we are unable to successfully commercialize RASONQUE, or if we or our collaborators do not receive marketing approvals for our other product candidates, our business, financial condition and results of operations could be materially harmed.
Previous wording
In order to obtain approval from the FDA or comparable foreign authorities to market a new small molecule product, we must demonstrate proof of safety and efficacy in humans. To meet these requirements, we will have to conduct adequate and well-controlled clinical trials. Before we can commence clinical trials for a product candidate, we must complete extensive preclinical studies that support our planned INDs in the United States. We cannot be certain of the timely completion or outcome of our preclinical studies and cannot predict if the FDA or foreign authorities will accept our proposed clinical programs or if the outcome of our preclinical studies will ultimately support further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing additional clinical trials to begin.
Current wording
In order to obtain approval from the FDA or comparable foreign authorities to market a new small molecule product, we must demonstrate proof of safety and efficacy in humans. To meet these requirements, we will have to conduct adequate and well-controlled clinical trials. Before we can commence clinical trials for a product candidate, we must complete extensive preclinical studies that support our planned INDs in the U.S. We cannot be certain of the timely completion or outcome of our preclinical studies and cannot predict if the FDA or foreign authorities will accept our proposed clinical programs or if the outcome of our preclinical studies will ultimately support further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing additional clinical trials to begin.
Previous wording
inability to generate sufficient preclinical or other in vivoor in vitro data to support the initiation of clinical studies;
Current wording
inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical studies;
Previous wording
We are evaluating our product candidates in registrational trials, including RASolute 302, RASolute 303, RASolute 304, RASolute 305, RASolute 309, RASolve 301 and RASolve 308, and are currently planning additional registrational clinical trials for daraxonrasib and our other RAS(ON) inhibitors. These studies may not produce results that are consistent with expectations based on our earlier clinical observations for these compounds. Similarly, results from our registrational trials may not be predictive of the results in other clinical trials evaluating different lines of therapy or tumor types. Our plans for these and future planned registrational trials are, and will be based on our observations from the results of early-stage clinical trials using the same product candidates. Based on data from early-stage clinical trials, we will select, subject to regulatory feedback, the proposed indication, line of therapy, study design and dose and dose schedule for our registrational studies. However, these registrational studies, if initiated, may not be successful and may not produce results that are consistent with our expectations, based on our earlier clinical observations, including because other trial designs may have greater likelihood of development success. Further, we recently announced that RASolute 302 met all primary and key secondary endpoints, including PFS and OS. However, this success may not be predictive of the results of clinical trials in other lines of therapy or tumor types.
Current wording
We are evaluating our product candidates, including RASONQUE and our other RAS(ON) inhibitors in trials across a range of indications and tumor types. Our plans for these and future planned registrational trials are and will be based on our observations from the results of early-stage clinical trials using the same product candidates. Based on data from early-stage clinical trials, we will select, subject to regulatory feedback, the proposed indication, dose and dose schedule, and other study design elements for our registrational studies. However, these registrational studies, if initiated, may not be successful and may not produce results that are consistent with our expectations, based on our earlier clinical observations.
Previous wording
The timely completion of clinical trials in accordance with their protocols depends, among other things, on the ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials to such trial’s conclusion as required by the FDA or other comparable regulatory authorities. We or our future collaborators may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including:
Current wording
The timely completion of clinical trials in accordance with their protocols depends, among other things, on the ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may not be able to initiate or continue clinical trials for our products or product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials to such trial’s conclusion as required by the FDA or other comparable regulatory authorities. We or our future collaborators may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including:
Previous wording
the availability or anticipated availability of our product candidates, including daraxonrasib, as approved therapies or through pre-license patient access programs, and clinicians’ and patients’ views regarding treatment sequencing or the potential advantages of receiving an approved therapy rather than participating in a clinical trial;
Current wording
the availability or anticipated availability of our product candidates as approved therapies or through pre-license patient access programs, and clinicians’ and patients’ views regarding treatment sequencing or the potential advantages of receiving an approved therapy rather than participating in a clinical trial;
Previous wording
the risk that patients enrolled in clinical trials will not remain on the trial through the completion of evaluation; and
Current wording
the risk that patients enrolled in clinical trials will not remain on the trial through the completion of evaluation;
Previous wording
In addition, our clinical trials will compete with approved therapies, including sotorasib and adagrasib, as well as other clinical trials for product candidates that are in the same therapeutic areas (and that seek to evaluate patients with cancer cells having the same mutations), particularly for patients having KRAS G12C, KRAS G12D or KRAS G12V mutations, as our current and potential future product candidates. See “Item 1. Business—Competition” of our Annual Report on Form 10-K for the year ended December 31, 2025 for additional information regarding our competitors. This competition and competition with approved therapies will reduce the number and types of patients available for clinical trials involving our product candidates, because some patients who might have opted to enroll in our trials may instead opt to pursue a treatment regimen using an approved therapy or enroll in a trial conducted by one of our competitors. Because the number of qualified clinical investigators is limited, we conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such sites. Moreover, because our current and potential future product candidates may represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in our ongoing or any future clinical trials.
Current wording
In addition, our clinical trials will compete with approved therapies, including sotorasib and adagrasib, and RASONQUE itself, as well as other clinical trials for product candidates that are in the same therapeutic areas (and that seek to evaluate patients with cancer cells having the same mutations), particularly for patients having KRAS G12C, KRAS G12D or KRAS G12V mutations, as our current and potential future product candidates. See “Item 1. Business—Competition” of our Annual Report on Form 10-K for the year ended December 31, 2025 for additional information regarding our competitors. This competition and competition with approved therapies will reduce the number and types of patients available for clinical trials involving our product candidates, because some patients who might have opted to enroll in our trials may instead opt to pursue a treatment regimen using an approved therapy or enroll in a trial conducted by one of our competitors. Because the number of qualified clinical investigators is limited, we conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such sites. Moreover, because our current and potential future product candidates may represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in our ongoing or any future clinical trials.
Previous wording
We and our collaborators are currently developing, and may in the future develop, our product candidates in combination with other therapies, which exposes us to additional risks.
Current wording
We and our collaborators are currently developing, and may in the future develop, our products or product candidates in combination with other therapies, which exposes us to additional risks.
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Current report — wording carried from elsewhere
Even though we have obtained regulatory approval to market RASONQUE, and even if we successfully obtain regulatory approval to market any other product candidate, our revenue will depend, in part, upon the size of the markets in the territories for which we or collaborators gain regulatory approval and have commercial rights, as well as the availability of competitive products, whether there is sufficient third-party reimbursement and adoption by physicians.
Current report — wording carried from elsewhere
Federal law requires that any company that participates in the MDRP also participate in the Public Health Service’s 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid. We also participate in the 340B program, which is administered by the Health Resources and Services Administration (HRSA), and requires us to charge statutorily defined covered entities no more than the 340B “ceiling price” for our covered outpatient drugs for which we have obtained approval. These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients. The 340B ceiling price is calculated using a statutory formula based on the AMP and rebate amount for the covered outpatient drug as calculated under the
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Previous report — wording carried elsewhere
information published after commercial launch that favors competing therapies or otherwise alters prescribing practices.
Previous report — wording carried elsewhere
It is difficult to predict at this time what government authorities and third-party payors will decide with respect to coverage and reimbursement for our programs.
Previous report — wording carried elsewhere
The CNPV Pilot Program, however, is new, limited in scope, and subject to evolving guidance and available FDA resources. The FDA retains broad discretion to modify the criteria, processes, or benefits of the pilot and may rescind participation or alter timelines or the intended benefits at any time.
Previous report — wording carried elsewhere
DSP imposes stringent obligations on companies within its scope and prohibits or restricts “covered data transactions” that grant countries of concern or covered persons access to bulk U.S. sensitive personal data or any amount of government-related data. The DSP is new, complex and has yet to be enforced, and as such, there is a risk that our interpretation of its applicability, scope, and requirements is incorrect, incomplete, or misapplied. Compliance with the DSP may require us to invest heavily in data security and compliance measures, such as implementing and complying with the Cybersecurity and Infrastructure Security Agency’s guidelines and other burdensome recordkeeping, reporting, and auditing requirements. It may also require us to implement new processes, stop or restrict certain data transfers, alter the geographic scope of our operations, cease doing business with certain third parties or using certain tools or vendors, or change how data flows throughout our business, any of which could materially impact our business operations or hinder our ability to grow our business. Finally, non-compliance with the DSP could result in significant civil or criminal penalties, which could materially adversely affect our business, results of operations, and financial condition.