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PMVP 10-K & 10-Q changes, risk factors and insider trading

PMV Pharmaceuticals, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1699382 · All filings on SEC.gov

Everything below is quoted or computed from PMV Pharmaceuticals, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

8 / 3risk-factor paragraphs added / removed in latest 10-K
0new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-06 (period ending 2025-12-31) with 10-K filed 2025-03-03 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

8new paragraphs
3removed paragraphs
23reworded paragraphs
43,475 → 44,284words in section

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: investigation, fine, penalt, export control
“Our products candidates and technology, in some cases, may be subject to export control laws and regulations, including the Export Administration Regulations administered by the U.S. Department of Commerce, and our product candidates, technology, and activities are subject to trade and economic sanctions, including those administered by the U.S. Treasury Department’s Office of Foreign Assets Control, or OFAC. As such, licenses and notices may be required to export, import or re-export our product candidates or technology to certain countries and end users and for certain end uses. …”
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New text topics: tariff, russia, ukraine, middle east
“general economic, political, industry and market conditions, including the Ukraine-Russia war and the conflict in the Middle East, the impact of other disruptions resulting from public health epidemics, macroeconomic events such as future changes in trade regulations, tariff structures, global supply chain challenges, elevated inflation and interest rates and monetary policy changes (including the impact of changes to U.S. federal income tax law), instability in the global banking system; and other events or factors, many of which are beyond our control.”
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Reworded topics: litigation, fine, penalt, breach

Paragraph as it now reads, with added and removed wording marked:

Among other matters, we aremay be subject to U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, foreign investment, data transfer,investment and other trade laws and regulations, which are collectively referred to as Trade Laws. TheseAnti-bribery Tradeand Lawsanti-corruption canlaws prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We also expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.
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New text topics: litigation, fine, penalt, breach
“Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.”
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Reworded topics: investigation, tariff, china

Paragraph as it now reads, with added and removed wording marked:

We currently contract certain product development and manufacturing operations to third parties outside the United States, including in China, and we expect to continue to use such third-party manufacturers for such product candidates. Any disruption in production or inability of our manufacturers in China to produce adequate quantities to meet our needs, whether as a result of a natural disaster or other causes could impair our ability to operate our business on a day-to-day basis and to continue our development of our product candidates. Furthermore, since these manufacturers are located in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China. For example, a trade war could lead to tariffs on the chemical intermediates and active pharmaceuticals ingredients we use that are manufactured in China. AnyBeginning in February 2025, the United States imposed an additional 10-20% tariff on most imports from China. Since April 2025, the United States and China have imposed significant additional reciprocal tariffs of 10-125% on a large proportion of imports from the respective trading partner; though currently these reciprocal tariffs are limited to 10% through November 2026, both countries may continue to pursue new and/or retaliatory tariff and trade policies as bilateral trade negotiations progress. Moreover, the United States also implemented additional reciprocal tariffs of 10% on the import of a large proportion of imports from most U.S. trading partners beginning in April 2025, and which increased to elevated, country-specific rates for certain trading partners beginning in August 2025. Although certain products have been exempted from some of these mattersreciprocal tariffs, including many pharmaceutical products, these policies are subject to change. In addition, the United States initiated an investigation into pharmaceuticals and pharmaceutical products in April 2025, the results of which could result in additional tariffs on pharmaceutical and pharmaceutical products under authorities provided in Section 232 of the Trade Expansion Act of 1962; whether, when, which products, and at what level such items may become subject to these additional tariffs is uncertain. Though announcements in September 2025 indicated that a 100% Section 232 tariff on branded or patented pharmaceutical products would be forthcoming, with a possible exemption for manufacturers who have broken ground or begun construction on U.S. manufacturing facilities, this policy has not been formalized in an executive action and details and timing are currently unclear. These and other changes in tariffs and trade policies of the United States or its trading partners may affect our products or our customers, and could materially adversely affect our business, financial condition and results of operations. Any recall of the manufacturing lots or similar action regarding our product candidates used in clinical trials could delay the trials or detract from the integrity of the trial data and its potential use in future regulatory filings. In addition, manufacturing interruptions or failure to comply with regulatory requirements by any of these manufacturers could significantly delay clinical development of potential products and reduce third-party or clinical researcher interest and support of proposed trials. These interruptions or failures could also impede commercialization of our product candidates and impair our competitive position. Further, we may be exposed to fluctuations in the value of the local currency in China. Future appreciation of the local currency could increase our costs. In addition, our labor costs could continue to rise as wage rates increase due to increased demand for skilled laborers and the availability of skilled labor declines in China.
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Reworded topics: litigation, lawsuit, regulation

Paragraph as it now reads, with added and removed wording marked:

Further, in Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir. 2021), the court disagreed with the FDA’s longstanding position that the orphan drug exclusivity only applies to the approved use or indication within an eligible disease. ThisHowever, decision created uncertainty in the application of the orphan drug exclusivity. Onon January 24, 2023, the FDA published a notice in the Federal Register to clarify that while the agency complies with the court’s order in Catalyst, FDA intends to continue to apply its longstanding interpretation of the regulations to matters outside of the scope of the Catalyst order – that is, the agency will continue tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved, which permits other sponsors to obtain approval of a drug for new uses or indications within the same orphan designated disease or condition that have not yet been approved. InThe viewConsolidated Appropriations Act of 2026, signed into law in February 2026, codified this longstanding FDA interpretation of the overturnOrphan ofDrug theAct, Chevron doctrine in Loper Bright Enterprises v. Raimondo, this landmark Supreme Court decision may invite various stakeholders to bring lawsuits againstallowing the FDA to challengeapprove longstandingmultiple decisions and policies, including regulatory exclusivities, which could lead to uncertainties in the industry. Further, changes in the leadershipversions of the FDA and other federal agencies under the Trump administration may lead to new policies and changes in the regulations and operations of the FDA, which may impact our clinical development plans. It is unclear how future litigation, legislation, agency decisions, and administrative actions will impact the scope of thesame orphan drug exclusivity.for different subindications and subpopulations.
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Full comparison: every changed paragraph (34)

Green = added, red = removed. Unchanged paragraphs, 3 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

We are a clinical stage biotechnology company with a limited operating history. We commenced operations in March 2013, and our operations to date have been primarily limited to organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates, undertaking preclinical studies and, more recently, clinical studies, and establishing arrangements with third parties for the manufacture of initial quantities of product candidates. Our lead product candidate, rezatapopt, received authorization to proceed under an IND with the FDA in September 2020 and then received Fast Track designation in October 2020. In the fourth quarter of 2020, we initiated patient dosing in our Phase 1/2 clinical trial of rezatapopt. We announced preliminary results from the Phase 1/2 clinical trial of rezatapopt in June 2022. In October 2023, we announced updated Phase 1 results from the Phase 1/2 clinical trial of rezatapopt, and we dosed our first patient in the pivotal Phase 2 monotherapy portion of the trial in the first quarter of 2024. In OctoberSeptember 2024,2025, we discontinuedannounced enrollmentinterim indata from the Phase 1b2 combinationpivotal armportion of the PYNNACLE trialclinical evaluatingtrial, which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In March 2026, rezatapopt inwas combinationgranted withODD Merckfrom andthe Co.’sFDA anti-PD-1for therapythe KEYTRUDA®treatment (pembrolizumab) in patients with advanced solid tumors harboring aof TP53 Y220C mutation.positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. We have not demonstrated an ability to successfully complete any clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

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Our ability to become profitable depends upon our ability to generate revenue. We have not received marketing approval for any product candidate, and we have not generated any revenue from any product sales. We do not expect to generate revenue unless or until we successfully complete preclinical and clinical development and obtain regulatory approval of, and then successfully commercialize, at least one product candidate. We announced preliminary results for our Phase 1/2 clinical trial of our lead product candidate, rezatapopt, in June 2022, and announced updated Phase 1 results in October 2023.2023 and announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial, which was updated in October 2025. We are continuing to transition from a company with a research focus to a company capable of supporting clinical development and commercial activities. We have not yet demonstrated our ability to successfully complete large-scale, pivotal clinical trials, 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. In addition, all of our other product candidates are still in preclinical development and have not been evaluated in humans. We face significant translational risk as our product candidates advance to the clinical stage, and promising results in preclinical studies may not be replicated in clinical trials. All of our current and future product candidates will require preclinical and clinical development, regulatory review and approval, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. Our ability to generate revenue depends on a number of factors, including, but not limited to:

Reworded

Developing biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek marketing approval for, rezatapopt, and advance our future product candidates. Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with sales, marketing, manufacturing and distribution activities. Our expenses could increase beyond expectations if we are required by the FDA or other regulatory agencies to modify the design of our clinical trials or perform preclinical studies or clinical trials in addition to those that we currently anticipate. Other unanticipated costs may also arise. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of any product candidate we develop. Accordingly, we will need to obtain substantial additional funding in order to continue our operations.

Reworded

As of December 31, 2024,2025, we had $183.3$112.9 million in cash, cash equivalents, and marketable securities. Although we believe that our available cash, cash equivalents, and marketable securities will be sufficient to fund our planned operations at least throughuntil the end of 2026,the second quarter of 2027, this belief is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. This belief also does not reflect the possibility that we may not be able to access a portion of our existing cash and cash equivalents due to market conditions. The failure of a bank, or other adverse conditions in the financial or credit markets impacting financial institutions at which we maintain balances, could adversely impact our liquidity and financial performance. There can be no assurance that our deposits in excess of the FDIC or other comparable insurance limits will be backstopped by the United States, or that any bank or financial institution with which we do business will be able to obtain needed liquidity from other banks, government institutions or by acquisition in the event of a failure or liquidity crisis.

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The discovery and development of precision medicines for patients with genomically defined cancers is an emerging field, and the scientific discoveries that form the basis for our efforts to discover and develop product candidates are relatively new. The scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. Further, despite decades of research on p53 as a target for precision medicines, prior product development efforts have been unsuccessful. Although we believe, based on our preclinical work and p53 research generally, that the top ten most frequent, or hotspot, p53 mutations have potential as precision oncology targets, clinical trial results may not confirm this hypothesis or may only confirm it for certain mutations or certain tumor types.

Reworded

In addition, because our approach targets genomically defined cancer patients and not specific tumors based on tumor or cancer types, we are pursuing a tumor-agnostic development strategy (i.e., pursuing approval for a potential indication based on a specific genetic mutation rather than a specific type of tissue). There is currently a limited number of approved tumor-agnostic therapies and we may not receive approval for a broad tumor-agnostic indication or may be delayed in receiving broad tumor-agnostic approval. For example, in October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. We subsequently announced that we are collaborating with the MD Anderson Cancer Center and the Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacitidine in R/R AML and MDS patients harboring a TP53 Y220C mutation. If our Phase 1/2 trial for rezatapopt does not support a tumor-agnostic indication, but we observe clinical benefit in certain tumor or cancer types, we may decide to pursue a tumor- or cancer-specific indication which may require additional clinical trials. Further, even if our Phase 1/2 trial for rezatapopt is successful, the FDA may not agree that such study can serve as a pivotal study, which would require us to conduct additional clinical trials prior to approval.

Reworded

Companion diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities outside the United States as medical devices (or in vitro diagnostic devices) and require separate regulatory approval or clearance prior to commercialization. Moreover, the FDA generally requires the contemporaneous approval of companion diagnostics and the associated therapeutic. Changes in the FDA leadership, regulatory actions and other actions under the Trumpcurrent administration, including changes in the FDA’s regulation of diagnostic tests, may impact our development of a companion diagnostic for our product candidates and result in delays in regulatory approval.

Added

legislation or other measures that restrict business, trade, or use of government funding for any product or service rendered by certain companies based in China or Chinese-owned U.S. companies due to national security concerns or geopolitical issues, and our reliance on such Chinese companies, including CROs, contract manufacturing organization, or CMOs, suppliers, and other vendors or contractors based in China. For example, the President recently signed into law the National Defense Authorization Act of 2026, which includes Section 851 regarding “prohibition on contracting with certain biotechnology providers” (“the BIOSECURE Act”), which restricts federal government contracts, grants, and loans from being issued to companies that use biotechnology equipment or services from any designated “biotechnology company of concern,” as part of such companies’ performance of those agreements with the U.S. government. Once fully implemented through issuance of regulations, the BIOSECURE Act may ultimately limit certain U.S. biotechnology companies from using equipment or services produced or provided by Chinese biotechnology companies that meet the designation criteria of the new law, or certain affiliated entities. In addition, even if we do not seek any covered federal government contracts, grants, or loans, commercial partners, government agencies, or other third parties may view our business less favorably if we contract with entities that ultimately become biotechnology companies of concern;

Removed

legislation or other measures that restrict business, trade, or use of government funding for any product or service rendered by certain companies based in China or Chinese-owned U.S. companies due to national security concerns or geopolitical issues, and our reliance on such Chinese companies, including CROs, contract manufacturing organization, or CMOs, suppliers, and other vendors or contractors based in China. For example, proposed legislation in Congress known as the BIOSECURE Act, or similar legislation, could limit our ability to work with CROs or CMOs in China and would restrict the purchase of services or products from certain specified companies in China. This new or proposed legislation, or similar legislation in the future, could adversely impact our current or future third-party arrangements with certain companies, including those in China or Chinese-owned U.S. companies, which could delay or impact clinical trials and consequently delay or obstruct successful commercialization of our drug candidates;

Reworded

regulations or other potentially new measures that,that arise for national security or geopolitical reasons, including those that would affect the transfer of certain types of data abroad, including toChina. China; forFor example, the Department of Justice recently issued a final rule which takestook effect in April 2025 that places limitations, and in some cases prohibitions, on certain transfers of sensitive personal data to business partners located in China and other designated countries, or with other specified links to China and other designated countries. These rules also may broadly require us to extract promises from other third-party service providers that they will not transfer data we share with them onward to parties linked to countries of concern;

Added

In particular, we are aware of molecules in development that also are being explored for p53 upregulation/activation in various stages of preclinical or clinical development being tested by Jacobio Pharmaceuticals, Changchun GeneScience, Frontier Medicines, and Nutshell Therapeutics, among others.

Removed

In particular, we are aware of molecules in development that also are being explored for p53 upregulation/activation in various stages of preclinical or clinical development being tested by Jacobio Pharmaceuticals, Frontier Medicines, Nutshell Therapeutics, Scorpion Therapeutics and AstraZeneca, among others. We are also aware of selective small molecule inhibitors that are designed to target wild-type p53 containing tumors through the p53-murine double minute 2, or MDM2, interaction, which are in various stages of clinical development being tested by Aileron Therapeutics, Ascentage Pharma, Boehringer Ingelheim, Kartos Therapeutics, Kymera Therapeutics, Otsuka Pharmaceutical, Novartis and Roche, including testing MDM2 inhibitors in combination with a variety of other anti-cancer agents.

Reworded

WeAlthough we have received orphan drug designation (ODD) for rezatapopt, we may not be able to obtain orphan drug designation or obtain or maintain the benefits associated with orphan drug designation,ODD, such as orphan drug exclusivity and, even if we do, that exclusivity may not prevent the FDA or other comparable foreign regulatory authorities,authorities from approving competing products.

Reworded

As part of our business strategy, we sought and received ODD for rezatapopt for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer, and we may seek orphan drug designation, or ODD,ODD for any eligible product candidates we develop,develop andin wethe may be unsuccessful.future. Regulatory authorities in some jurisdictions, including the United States and the European Union, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing and making available the drug will be recovered from sales in the United States. Our target indications may include diseases with large patient populations or may include orphan indications. However, there can be no assurances that we will be able to obtain orphan designations for our product candidates.

Reworded

Further, in Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir. 2021), the court disagreed with the FDA’s longstanding position that the orphan drug exclusivity only applies to the approved use or indication within an eligible disease. ThisHowever, decision created uncertainty in the application of the orphan drug exclusivity. Onon January 24, 2023, the FDA published a notice in the Federal Register to clarify that while the agency complies with the court’s order in Catalyst, FDA intends to continue to apply its longstanding interpretation of the regulations to matters outside of the scope of the Catalyst order – that is, the agency will continue tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved, which permits other sponsors to obtain approval of a drug for new uses or indications within the same orphan designated disease or condition that have not yet been approved. InThe viewConsolidated Appropriations Act of 2026, signed into law in February 2026, codified this longstanding FDA interpretation of the overturnOrphan ofDrug theAct, Chevron doctrine in Loper Bright Enterprises v. Raimondo, this landmark Supreme Court decision may invite various stakeholders to bring lawsuits againstallowing the FDA to challengeapprove longstandingmultiple decisions and policies, including regulatory exclusivities, which could lead to uncertainties in the industry. Further, changes in the leadershipversions of the FDA and other federal agencies under the Trump administration may lead to new policies and changes in the regulations and operations of the FDA, which may impact our clinical development plans. It is unclear how future litigation, legislation, agency decisions, and administrative actions will impact the scope of thesame orphan drug exclusivity.for different subindications and subpopulations.

Reworded

In addition, the FDA and other regulatory authorities may change their policies, issue additional regulations or revise existing regulations, or take other actions, such as those implemented by the Department of Government Efficiency, which may prevent or delay approval of our future products under development on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained. In view of the Loper Bright Enterprises v. Raimondo decision, this landmark Supreme Court decision may invite various stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies. Additionally, changes in the leadership of the FDA and other federal agencies under the Trumpcurrent administration may also lead to new policies and changes in the regulations and operations of the FDA, which may impact our clinical development plans.

Reworded

Changes in funding or disruptions at the FDA, the SEC and other government agencies caused by funding shortages or global health concernsconcerns, government shutdown, or a lapse of U.S. government appropriations could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

Reworded

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes and other events that may otherwise affect the FDA’s ability to perform routine functions. Changes in the leadership of the FDA and other federal agencies under the Trumpcurrent administration, including return-to-office policy, hiring freeze, andlayoffs, layoffs,government shutdown, or a lapse of U.S. government appropriations may also lead to changes in the operations of the FDA, which may have a material impact on the industry. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Reworded

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. The U.S. Supreme Court’s overturn of the Chevron doctrine in Loper Bright Enterprises v. Raimondo may invite various stakeholders to bring lawsuits against the FDA and other federal agencies to challenge longstanding decisions and policies, which could lead to uncertainty in the industry. Further, changes to the leadership of the FDA and other federal agencies under the Trumpcurrent administration may result in changes in agencies’ funding, operations, and policies, which may impact our clinical development plans and timelines. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. FDA’s “real-time” release of newly issued Complete Response Letters associated with withdrawn or abandoned applications, if applicable to any of our product candidates, can materially impact our competitive advantage and intellectual property. To the extent any current or future executive or legislative actions impose significant changes in or burdens on, or otherwise materially delay, FDA’s ability to engage in routine oversight activities, such as implementing regulations through rulemaking, issuance of guidance, and agency review and approval of marketing applications on a timely basis, our business and clinical development plans could be negatively impacted. If we, as well as our contractors, are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or are not able to maintain regulatory compliance, we may be delayed in obtaining regulatory approval, lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.

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There have been executive, judicial and Congressional challenges to certain aspects of the ACA. For example, on June 17, 2021 the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the ACA will remain in effect in its current form. Prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how such challenges and the healthcare reform measures of the Trumpcurrent administration will impact the ACA and our business.

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There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, for example, the American Rescue Plan Act of 2021 eliminated the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products, which could have a material impact on our business. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, CMS selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. Various industry stakeholders, including certain pharmaceutical companies and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act of 2022 are unconstitutional. The impact of these judicial challenges, legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the Trumpcurrent administration us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.

Added

Further, the current administration has issued executive orders focused on decreasing prescription drug prices. Government contracts with pharmaceutical companies and other government measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or that increase generic and biosimilar drug entry sooner than expected, can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.

Reworded

Further, national security concerns or changing geopolitical tensions could spur regulations that limit our ability to transfer certain types of data abroad. For example, the Department of Justice recently issued a final rule which takestook effect in April 2025 that places limitations, and in some cases prohibitions, on certain transfers of sensitive personal data to business partners located in China and other designated countries, or with other specified links to China and other designated countries. These rules also may broadly require us to extract promises from other third-party service providers that they will not transfer data we share with them onward to parties linked to countries of concern.

Reworded

We aremay be subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, foreign investment, data transferinvestment and other trade laws and regulations. We can face serious consequences for violations.

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Among other matters, we aremay be subject to U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, foreign investment, data transfer,investment and other trade laws and regulations, which are collectively referred to as Trade Laws. TheseAnti-bribery Tradeand Lawsanti-corruption canlaws prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We also expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

Added

We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We also expect our non-U.S. activities to increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

Added

Our products candidates and technology, in some cases, may be subject to export control laws and regulations, including the Export Administration Regulations administered by the U.S. Department of Commerce, and our product candidates, technology, and activities are subject to trade and economic sanctions, including those administered by the U.S. Treasury Department’s Office of Foreign Assets Control, or OFAC. As such, licenses and notices may be required to export, import or re-export our product candidates or technology to certain countries and end users and for certain end uses. The process for obtaining necessary licenses and making required notices may be time-consuming or unsuccessful, potentially causing delays in sales or losses of sales opportunities. Export controls and sanctions are complex and dynamic regimes and monitoring and ensuring compliance can be challenging. Any failure to comply with these regimes could subject us to both civil and criminal penalties, including substantial fines, possible incarceration of responsible individuals for willful violations, possible loss of our export or import privileges, and reputational harm. In addition, investigating or defending against any such allegations, actions or investigations will likely result in a materially significant diversion of management’s attention and resources and significant defense costs and other professional fees.

Added

We also may be subject to review under U.S. or other national-security or foreign-investment laws and regulations when foreign persons invest in us or when we engage in certain cross-border transactions. Such review may delay or prevent proposed investments or transactions, impose material conditions or require divestiture, and failure to comply with or to obtain required clearance could have a material adverse effect on our business, financial condition and results of operations.

Added

Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

Reworded

In addition, under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change” (generally defined as a cumulative change (by value) in the corporation’s ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and certain other pre-change tax attributes to offset its post-change taxable income or tax liabilities may be limited. Similar rules or other limitations may apply under state tax laws. We have experienced such ownership changes in the past, and we may experience ownership changes in the future as a result of shifts in our stock ownership, some of which are outside our control. At this time, we have not conducted any studies to determine the annual limitations, if any, that resulted from such an ownership change. Our ability to utilize our NOLs and certain other tax attributes could be limited by an ownership change as described above and consequently, we may not be able to utilize a material portion of our NOLs and certain other tax attributes, which could have a material adverse effect on our cash flows and results of operations. There is also a risk that due to federal or state regulatory changes, such as suspensions on the use of NOLs, our existing NOLs could expire or otherwise be unavailable to offset future income tax liabilities.

Reworded

New income, sales, use or other tax laws or regulations could be enacted at any time, which could affect our tax profile and our business and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, the TCJA eliminated the option to deduct research and development expenditures currently and requires taxpayers to capitalize and amortize such expenditures over five or 15 years pursuant to Section 174 of the Code, beginning in 2022. WhenOn andJuly if4, we2025, achievethe profitability,U.S. thesefederal tax legislation commonly referred to as the One Big Beautiful Bill Act, or the OBBB Act, was enacted, which makes a number of changes may cause us to payU.S. federal income taxestax earlierlaw, thanincluding underpermanently priorsuspending lawthe requirement to capitalize and mayamortize increase our total federal tax liability attributable to orphan drug programs and otherdomestic research and development activities.expenditures and permitting such deductions on a current basis. We are currently evaluating the full impact of the OBBB Act on us. Further, the Inflation Reduction Act of 2022, among other changes, imposes a one-percent excise tax on stock repurchases made on or after January 1, 2023. Any further changes in tax laws or regulations that are applied adversely to us could have a material adverse effect on our business, financial condition and results of operations.

Reworded

We currently contract certain product development and manufacturing operations to third parties outside the United States, including in China, and we expect to continue to use such third-party manufacturers for such product candidates. Any disruption in production or inability of our manufacturers in China to produce adequate quantities to meet our needs, whether as a result of a natural disaster or other causes could impair our ability to operate our business on a day-to-day basis and to continue our development of our product candidates. Furthermore, since these manufacturers are located in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China. For example, a trade war could lead to tariffs on the chemical intermediates and active pharmaceuticals ingredients we use that are manufactured in China. AnyBeginning in February 2025, the United States imposed an additional 10-20% tariff on most imports from China. Since April 2025, the United States and China have imposed significant additional reciprocal tariffs of 10-125% on a large proportion of imports from the respective trading partner; though currently these reciprocal tariffs are limited to 10% through November 2026, both countries may continue to pursue new and/or retaliatory tariff and trade policies as bilateral trade negotiations progress. Moreover, the United States also implemented additional reciprocal tariffs of 10% on the import of a large proportion of imports from most U.S. trading partners beginning in April 2025, and which increased to elevated, country-specific rates for certain trading partners beginning in August 2025. Although certain products have been exempted from some of these mattersreciprocal tariffs, including many pharmaceutical products, these policies are subject to change. In addition, the United States initiated an investigation into pharmaceuticals and pharmaceutical products in April 2025, the results of which could result in additional tariffs on pharmaceutical and pharmaceutical products under authorities provided in Section 232 of the Trade Expansion Act of 1962; whether, when, which products, and at what level such items may become subject to these additional tariffs is uncertain. Though announcements in September 2025 indicated that a 100% Section 232 tariff on branded or patented pharmaceutical products would be forthcoming, with a possible exemption for manufacturers who have broken ground or begun construction on U.S. manufacturing facilities, this policy has not been formalized in an executive action and details and timing are currently unclear. These and other changes in tariffs and trade policies of the United States or its trading partners may affect our products or our customers, and could materially adversely affect our business, financial condition and results of operations. Any recall of the manufacturing lots or similar action regarding our product candidates used in clinical trials could delay the trials or detract from the integrity of the trial data and its potential use in future regulatory filings. In addition, manufacturing interruptions or failure to comply with regulatory requirements by any of these manufacturers could significantly delay clinical development of potential products and reduce third-party or clinical researcher interest and support of proposed trials. These interruptions or failures could also impede commercialization of our product candidates and impair our competitive position. Further, we may be exposed to fluctuations in the value of the local currency in China. Future appreciation of the local currency could increase our costs. In addition, our labor costs could continue to rise as wage rates increase due to increased demand for skilled laborers and the availability of skilled labor declines in China.

Added

general economic, political, industry and market conditions, including the Ukraine-Russia war and the conflict in the Middle East, the impact of other disruptions resulting from public health epidemics, macroeconomic events such as future changes in trade regulations, tariff structures, global supply chain challenges, elevated inflation and interest rates and monetary policy changes (including the impact of changes to U.S. federal income tax law), instability in the global banking system; and other events or factors, many of which are beyond our control.

Removed

general economic, political, industry and market conditions, including the rising rate of inflation, the Ukraine-Russia war and the conflict between Israel and Hamas; and other events or factors, many of which are beyond our control.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

4new paragraphs
7removed paragraphs
10reworded paragraphs
4,916 → 4,334words in section

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: restructuring, workforce reduction
“In January 2024, we announced a restructuring plan involving the reduction of our workforce by approximately 30%. This workforce reduction resulted in non-recurring charges of $0.6 million in fiscal year ended December 31, 2024, consisting primarily of employee severance and benefit costs associated with the restructuring. We undertook these steps in order to streamline operations, reduce costs and preserve capital as we advance into late-stage development of rezatapopt. …”
see in full comparison
Reworded topics: labor

Paragraph as it now reads, with added and removed wording marked:

We do not allocate our costs by product candidate or development program, as a significant amount of research and development expenses include compensation costs, materials, supplies, depreciation on and maintenance of research equipment, and the cost of services provided by outside contractors, which are not tracked by product candidate or development program. In particular, with respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. Substantially all of our research and development costs are associated with our lead product candidate, rezatapopt. We initiated aour Phase 1/2 PYNNACLE clinical trial in October 2020.2020, Inand Octoberon 2020,that date, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. WeIn areSeptember continuing2025, towe doseannounced patientsinterim anddata have activated over 90% of sites globally acrossfrom the U.S., U.K., Europe and Asia-Pacific, in the registrational, tumor-agnostic PYNNACLE Phase 2 trialpivotal portion of the PYNNACLE clinical trial, which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In March 2026, rezatapopt inwas granted ODD from the FDA for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. We plan to submit an NDA for the treatment of patients with advancedplatinum-resistant/refractory solidovarian tumorscancer harboring a TP53 Y220C mutation and KRAS wild-type. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025. In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MDACC and MSK to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacitidine in R/R AML and MDS patients harboring a TP53 Y220C mutation. MDACC dosed its first patientFDA for this Phase 1b studyrezatapopt in the first quarter of 2025.2027.
see in full comparison
Reworded topics: labor

Paragraph as it now reads, with added and removed wording marked:

Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activities and raising capital. We are not profitable and have incurred losses in each year since our inception. Our net losses were $58.7$78.0 million, $69.0$58.7 million, and $73.3$69.0 million for the years ended December 31, 2025, 2024, 2023, and 2022,2023, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $368.7$446.7 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, rezatapopt. Our strategy is to seek approval under an accelerated pathway, and we believe ourthe Phase 2 portion of the PYNNACLE clinical trial has the potential to serve as a pivotal study. In October 2020, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we met with the FDA at an End of Phase 1 meeting where alignment was obtained on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Annual Meeting. We dosed our first patient in the pivotal Phase 2 monotherapy portion of the PYNNACLE study in the first quarter of 2024. WeIn areSeptember continuing2025, towe dose patients in the pivotal Phase 2 monotherapy portion of our PYNNACLE trial, and have activated over 90% of sites globally across the U.S., U.K., Europe and Asia-Pacific. We also expect to provideannounced interim data onfrom the Phase 2 monotherapy registrationalpivotal portion of the PYNNACLE trialclinical bytrial, mid-2025.which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In OctoberMarch 2024,2026, werezatapopt discontinuedwas enrollmentgranted inODD from the PhaseFDA 1bfor combinationthe armtreatment of theTP53 PYNNACLEY220C trialpositive evaluatingovarian rezatapoptcancer, infallopian combinationtube with Merckcancer, and Co.’sprimary anti-PD-1peritoneal therapycancer. KEYTRUDA®We (pembrolizumab)plan into submit a New Drug Application, or NDA, for the treatment of patients with advancedplatinum-resistant/refractory solidovarian tumorscancer harboring a TP53 Y220C mutation.mutation Additionally, we announced that we are collaborating withto the MDACC and MSK to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacitidine in R/R AML and MDS patients harboring a TP53 Y220C mutation. MDACC dosed its first patientFDA for this Phase 1b studyrezatapopt in the first quarter of 2025.2027.
see in full comparison
Removed text topics: restructuring
“$4.1 million increase in research and development expenses largely driven by increased contractual research organization costs; offset by $1.5 million decrease in expenses for personnel related costs and stock-based compensation, primarily as a result of the restructuring that occurred in January 2024. Refer to Note 12 of the notes to our audited consolidated financial statements for the year ended December 31, 2024 included elsewhere in this Annual Report on Form 10-K for details on the restructuring.”
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Reworded topics: restructuring

Paragraph as it now reads, with added and removed wording marked:

We use our capital resources primarily to fund operating expenses, mainly research and development expenditures. On January 18, 2024, we announced a restructuring plan involving the reduction of our workforce by approximately 30% of our employees and incurred costs of $0.6 million in connection therewith during the fiscal year ending on December 31, 2024. We undertook these steps in order to streamline operations, reduce costs and preserve capital as we advance our lead candidate, rezatapopt, into late-stage development. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
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Reworded topics: restructuring

Paragraph as it now reads, with added and removed wording marked:

$5.3$7.7 million increasedecrease in facility related costs due to the termination of our prior lease for our prior headquarters located at One Research Way in Princeton, New Jersey,Jersey; and $0.4 million increasedecrease in general and administrative consulting costs;costs, offset$0.1 bymillion $2.5decrease in director and officer insurance fees, and $2.4 million decrease in expenses for personnel related costs and stock-based compensation driven by the restructuring that occurred in January 2024, and $0.5 million decrease in director and officer insurance fees.compensation.
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Full comparison: every changed paragraph (21)

Green = added, red = removed. Unchanged paragraphs, 7 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

A discussion of our financial performance for the year ended December 31, 20242025 as compared to the year ended December 31, 20232024 appears below under the captions “Results of Operations” and “Liquidity and Capital Resources.” A discussion of our financial performance for the year ended December 31, 20232024 compared to the year ended December 31, 20222023 can be found in our Annual Report filed on Form 10-K, in the “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations”, under the same captions, filed with the SEC on FebruaryMarch 29,3, 2024,2025, which is available free of charge on the SEC’s website at www.sec.gov and our Investor Relations website at ir.pmvpharma.com/financial-information/sec-filings. These website addresses are intended to be inactive, textual references only. None of the materials on, or accessible through, these websites are part of this report or are incorporated by reference herein.

Reworded

Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activities and raising capital. We are not profitable and have incurred losses in each year since our inception. Our net losses were $58.7$78.0 million, $69.0$58.7 million, and $73.3$69.0 million for the years ended December 31, 2025, 2024, 2023, and 2022,2023, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $368.7$446.7 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, rezatapopt. Our strategy is to seek approval under an accelerated pathway, and we believe ourthe Phase 2 portion of the PYNNACLE clinical trial has the potential to serve as a pivotal study. In October 2020, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we met with the FDA at an End of Phase 1 meeting where alignment was obtained on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Annual Meeting. We dosed our first patient in the pivotal Phase 2 monotherapy portion of the PYNNACLE study in the first quarter of 2024. WeIn areSeptember continuing2025, towe dose patients in the pivotal Phase 2 monotherapy portion of our PYNNACLE trial, and have activated over 90% of sites globally across the U.S., U.K., Europe and Asia-Pacific. We also expect to provideannounced interim data onfrom the Phase 2 monotherapy registrationalpivotal portion of the PYNNACLE trialclinical bytrial, mid-2025.which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In OctoberMarch 2024,2026, werezatapopt discontinuedwas enrollmentgranted inODD from the PhaseFDA 1bfor combinationthe armtreatment of theTP53 PYNNACLEY220C trialpositive evaluatingovarian rezatapoptcancer, infallopian combinationtube with Merckcancer, and Co.’sprimary anti-PD-1peritoneal therapycancer. KEYTRUDA®We (pembrolizumab)plan into submit a New Drug Application, or NDA, for the treatment of patients with advancedplatinum-resistant/refractory solidovarian tumorscancer harboring a TP53 Y220C mutation.mutation Additionally, we announced that we are collaborating withto the MDACC and MSK to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacitidine in R/R AML and MDS patients harboring a TP53 Y220C mutation. MDACC dosed its first patientFDA for this Phase 1b studyrezatapopt in the first quarter of 2025.2027.

Removed

In January 2024, we announced a restructuring plan involving the reduction of our workforce by approximately 30%. This workforce reduction resulted in non-recurring charges of $0.6 million in fiscal year ended December 31, 2024, consisting primarily of employee severance and benefit costs associated with the restructuring. We undertook these steps in order to streamline operations, reduce costs and preserve capital as we advance into late-stage development of rezatapopt. We recorded these charges in research and development expenses in the accompanying consolidated statements of operations and comprehensive loss based on responsibilities of the impacted employees.

Reworded

We do not allocate our costs by product candidate or development program, as a significant amount of research and development expenses include compensation costs, materials, supplies, depreciation on and maintenance of research equipment, and the cost of services provided by outside contractors, which are not tracked by product candidate or development program. In particular, with respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. Substantially all of our research and development costs are associated with our lead product candidate, rezatapopt. We initiated aour Phase 1/2 PYNNACLE clinical trial in October 2020.2020, Inand Octoberon 2020,that date, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. WeIn areSeptember continuing2025, towe doseannounced patientsinterim anddata have activated over 90% of sites globally acrossfrom the U.S., U.K., Europe and Asia-Pacific, in the registrational, tumor-agnostic PYNNACLE Phase 2 trialpivotal portion of the PYNNACLE clinical trial, which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In March 2026, rezatapopt inwas granted ODD from the FDA for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. We plan to submit an NDA for the treatment of patients with advancedplatinum-resistant/refractory solidovarian tumorscancer harboring a TP53 Y220C mutation and KRAS wild-type. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025. In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MDACC and MSK to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacitidine in R/R AML and MDS patients harboring a TP53 Y220C mutation. MDACC dosed its first patientFDA for this Phase 1b studyrezatapopt in the first quarter of 2025.2027.

Reworded

We expect our research and development expenses to increase substantially in absolute dollars in the future as we advance our product candidates into and through clinical trials and pursue regulatory approval of our product candidates. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates may be affected by a variety of factors including: the safety and efficacy of our product candidates, early clinical data, investment in our clinical program, the ability of any future collaborators to successfully develop our licensed product candidates, competition, manufacturing capability, and commercial viability. We may never succeed in achieving regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects.

Reworded

Interest income, netnet, primarily consists of interest income from our interest-bearing cash, cash equivalents, and marketable securitiessecurities, and interest costs related to accretion and amortization of discounts and premiums on marketable securities.

Added

$13.1 million increase in development and personnel related expenses, largely driven by increased CRO costs for advancing our lead product candidate, rezatapopt, through the Phase 2 clinical trial; offset by $0.7 million decrease in research related costs driven by decreased pre-clinical CRO costs; and $1.0 million decrease for stock-based compensation.

Removed

$4.1 million increase in research and development expenses largely driven by increased contractual research organization costs; offset by $1.5 million decrease in expenses for personnel related costs and stock-based compensation, primarily as a result of the restructuring that occurred in January 2024. Refer to Note 12 of the notes to our audited consolidated financial statements for the year ended December 31, 2024 included elsewhere in this Annual Report on Form 10-K for details on the restructuring.

Reworded

General and administrative expenses were $16.3 million for the year ended December 31, 2025, compared to $26.9 million for the year ended December 31, 2024, compared to $24.2 million for the year ended December 31, 2023.2024. The increasedecrease of $2.7$10.6 million was primarily due to the following:

Reworded

$5.3$7.7 million increasedecrease in facility related costs due to the termination of our prior lease for our prior headquarters located at One Research Way in Princeton, New Jersey,Jersey; and $0.4 million increasedecrease in general and administrative consulting costs;costs, offset$0.1 bymillion $2.5decrease in director and officer insurance fees, and $2.4 million decrease in expenses for personnel related costs and stock-based compensation driven by the restructuring that occurred in January 2024, and $0.5 million decrease in director and officer insurance fees.compensation.

Reworded

Interest income, netnet, primarily consists of interest income from our interest-bearing cash, cash equivalents, and marketable securities and interest costs related to amortization of premiums and discounts on marketable securities. Interest income, net was $6.4 million for the year ended December 31, 2025, compared to $10.7 million for the year ended December 31, 2024, compared to $11.2 million for the year ended December 31, 2023.2024. The decrease of $0.5$4.3 million in 2024 was primarily due to decreasedthe amount of, and reduction of interest rates fromwith respect to, our cash investments in marketable securities and U.S. treasuries.

Removed

In January 2021, we signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey, or the One Research Way Lease. On August 5, 2024, we entered into a Lease Termination Agreement, or the Termination Agreement, with BMR-One Research Way LLC, a Delaware limited liability company, or the Landlord, to terminate the One Research Way Lease. We and the Landlord agreed to terminate the One Research Way Lease effective as of September 30, 2024, contingent on the sale of the property by the Landlord to a prospective new buyer, or the Contingency.

Removed

Pursuant to the Termination Agreement, and subject to the Contingency, we agreed to surrender our then-current headquarters at One Research Way and pay a total termination fee of approximately $1.42 million. The Contingency was satisfied in October 2024 and we paid the termination fee to the Landlord in October 2024. No further amounts or payments related to the One Research Way Lease are owed. The foregoing descriptions of the Termination Agreement is not complete and is qualified in its entirety by reference to the full text of the Termination Agreement, a copy of which was filed as Exhibit 10.1 to our Form 8-K filed with the SEC on August 8, 2024.

Reworded

We use our capital resources primarily to fund operating expenses, mainly research and development expenditures. On January 18, 2024, we announced a restructuring plan involving the reduction of our workforce by approximately 30% of our employees and incurred costs of $0.6 million in connection therewith during the fiscal year ending on December 31, 2024. We undertook these steps in order to streamline operations, reduce costs and preserve capital as we advance our lead candidate, rezatapopt, into late-stage development. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Reworded

Due to our significant research and development expenditures, we have generated substantial operating losses in each period since inception. We have incurred an accumulated deficit of $368.7$446.5 million through December 31, 2024.2025. We expect to incur substantial additional losses in the future as we expand our research and development activities.future. Our cash operating expenditures were $73.6 million in 2025 and $51.3 million in 2024 and $55.7 million in 2023.2024. Based on our research and development plans, we expect that our cash, cash equivalents, and marketable securities balances as of December 31, 20242025 will be sufficient to fund our planned operations at least throughuntil the end of 2026.the second quarter of 2027.

Added

Net cash used in operating activities for the year ended December 31, 2025, was $73.6 million, which consisted primarily of net loss of $77.7 million decreased by non-cash charges of $3.3 million and increased by a net change of $0.9 million in our net operating assets and liabilities. The non-cash charges primarily consisted of stock-based compensation of $5.9 million; offset by accretion of discounts on marketable securities of $2.8 million. The change in our net operating assets and liabilities was primarily due to a decrease in other assets and an increase in accrued expenses.

Removed

Net cash used in operating activities for the year ended December 31, 2023, was $55.7 million, which consisted primarily of net loss of $69.0 million decreased by non-cash charges of $7.9 million and a net change of $5.4 million in our net operating assets and liabilities. The non-cash charges primarily consisted of stock-based compensation of $12.4 million and depreciation of $1.3 million, partially offset by non-cash lease income of $0.4 million and accretion of premiums on marketable securities of $5.4 million. The change in our net operating assets and liabilities was primarily due to an increase in operating lease liabilities and other assets and an increase in accrued expenses.

Added

Our investing activities provided $70.2 million of cash during the year ended December 31, 2025, which consisted primarily of maturities of marketable securities of $158 million, offset by purchases of marketable securities of $88.2 million.

Removed

Our investing activities used $50.5 million of cash during the year ended December 31, 2023, which consisted primarily of purchases of marketable securities of $220.5 million, along with purchase of property and equipment of $1.0 million, offset by maturities of marketable securities of $171.0 million.

Added

Our financing activities provided $0.5 million of cash during the year ended December 31, 2025 which consisted of $0.5 million of proceeds from the exercise of stock options and issuance of common stock under the 2020 ESPP.

Removed

Our financing activities provided $35.6 million of cash during the year ended December 31, 2023. This consisted of $35.1 million of common stock issued under our ATM Program, net of issuance costs, and $0.5 million of proceeds from the exercise of stock options and issuance of common stock under the 2020 ESPP.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-14 (period ending 2026-06-30) with 10-Q filed 2026-05-12 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

2new paragraphs
0removed paragraphs
1reworded paragraphs
86 → 420words in section

New heading “There is substantial doubt as to our ability to continue as a going concern. We may need additional financing to execute our business plan, to fund our operations, and to continue as a going concern. Our disclosure regarding the substantial doubt as to our ability to continue as a going concern may hinder our ability to obtain further financing.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: going concern
“There is substantial doubt as to our ability to continue as a going concern. We may need additional financing to execute our business plan, to fund our operations, and to continue as a going concern. Our disclosure regarding the substantial doubt as to our ability to continue as a going concern may hinder our ability to obtain further financing.”
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New text topics: going concern, labor
“Due to our recurring operating losses and negative cash flows from operations and our dependence on and uncertainty around our ability to obtain additional financing to fund our operations after our current resources are exhausted, management has determined that our present capital resources may not be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report, and there is substantial doubt as to our ability to continue as a going concern. …”
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Paragraph as it now reads, with added and removed wording marked:

ThereOther than as described below, there have been no material changes to the Company’s risk factors as set forth in Part I, Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC on March 6, 2026, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the SEC on May 12, 2026, which are hereby incorporated by reference. You should carefully review and consider the information regarding such risk factors and the risks and uncertainties described elsewhere in this report which could materially affect our business, financial condition or future prospects.
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Reworded

ThereOther than as described below, there have been no material changes to the Company’s risk factors as set forth in Part I, Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC on March 6, 2026, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the SEC on May 12, 2026, which are hereby incorporated by reference. You should carefully review and consider the information regarding such risk factors and the risks and uncertainties described elsewhere in this report which could materially affect our business, financial condition or future prospects.

Added

There is substantial doubt as to our ability to continue as a going concern. We may need additional financing to execute our business plan, to fund our operations, and to continue as a going concern. Our disclosure regarding the substantial doubt as to our ability to continue as a going concern may hinder our ability to obtain further financing.

Added

Due to our recurring operating losses and negative cash flows from operations and our dependence on and uncertainty around our ability to obtain additional financing to fund our operations after our current resources are exhausted, management has determined that our present capital resources may not be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report, and there is substantial doubt as to our ability to continue as a going concern. Our ability to continue as a going concern will depend on our ability to obtain additional funding, which may divert management’s attention, and no assurances can be given that additional funding will be available to us on commercially reasonable terms, or at all. If we are unable to raise sufficient capital when needed, our business, financial condition and results of operations will be materially adversely affected, and we will need to modify our operational plans to continue as a going concern. If we are unable to obtain sufficient financing, we may be required to delay, reduce the scope of, or cease some or all of our research and development programs, or pursue strategic alternatives. Moreover, the reaction of investors to the inclusion of a going concern statement in our financial statements and our potential inability to continue as a going concern could adversely affect the price of our common stock and our ability to raise new capital or enter into collaborative or other transactions.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

16new paragraphs
2removed paragraphs
22reworded paragraphs
4,385 → 5,125words in section

New heading “Comparison of the Six Months ended June 30, 2026 and 2025”

New heading “Research and Development Expenses”

New heading “General and Administrative Expenses”

New heading “Interest Income, Net”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: going concern, liquidity, labor
“Our ability to continue as a going concern will depend on, among other things, our ability to obtain additional funding and appropriately manage the amount of cash used to fund our operations. We plan to address this condition through public or private equity, convertible or debt financing or capital obtained in connection with strategic collaborations or licensing or other sources. There are inherent uncertainties as the outcome of these potential transactions are outside management’s control, and therefore there are no assurances that any of these potential transactions will occur. …”
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New text topics: going concern, liquidity
“Management has determined that our current available cash, cash equivalents and marketable securities may not be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report, and there is substantial doubt as to our ability to continue as a going concern. For additional information, see “Note 1 — Formation and Business of the Company— Liquidity and Going Concern.””
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Reworded topics: going concern

Paragraph as it now reads, with added and removed wording marked:

Due to our significant research and development expenditures, we have generated substantial operating losses in each period since inception. We have incurred an accumulated deficit of $464.5$482.6 million through MarchJune 31,30, 2026. We expect to incur substantial additional losses in the future. For the threesix months ended MarchJune 31,30, 2026 and 2025, our cash operating expenditures were $19.7$34.3 million and $18.3$36.6 million, respectively. Based on our research and development plans, we expect that our cash, cash equivalents, and marketable securities as of MarchJune 31,30, 2026 will be sufficient to fund our planned operations until the end ofthrough the second quarter of 2027.2027, which is less than one year from the date of this Quarterly Report. As a result, management has determined that there is substantial doubt as to our ability to continue as a going concern.
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New text
“Comparison of the Six Months ended June 30, 2026 and 2025”
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New text
“General and Administrative Expenses”
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New text
“Research and Development Expenses”
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Full comparison: every changed paragraph (40)

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Reworded

You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes and other financial information included in this Quarterly Report on Form 10-Q and our audited condensed consolidated financial statements and notes thereto as of and for the years ended December 31, 2025 and 2024 and the related “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” including “Contractual Obligations and Commitments” and “Critical Accounting Policies and Estimates,” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission, or the SEC, on March 6, 2026. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” refer to PMV Pharmaceuticals, Inc.

Reworded

Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activitiesactivities, advancing our lead product candidate toward regulatory approval, and raising capital. We are not profitable and have incurred losses in each year since our inception. During the three and six months ended MarchJune 31,30, 2026, we incurred net losses of $18.0$18.1 million.million and $36.1 million, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $464.5$482.6 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general and administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, rezatapopt. Our strategy is to seek approval under an accelerated pathway, and we believe the Phase 2 portion of the PYNNACLE clinical trial has the potential to serve as a pivotal study. In October 2020, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we met with the FDA at an End of Phase 1 meeting where alignment was obtained on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Annual Meeting. We dosed our first patient in the pivotal Phase 2 monotherapy portion of the PYNNACLE study in the first quarter of 2024. In September 2025, we announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial, which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In March 2026, rezatapopt was granted Orphan Drug Designation, or ODD, from the FDA for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. In April 2026, we presented interim ovarian cancer data from the Phase 2 pivotal portion of the PYNNACLE clinical trial, in an oral presentation at the 2026 Society of Gynecologic Oncology Meeting. Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the study has been completed. We plan to submit aour initial New Drug Application, or NDA, via accelerated approval for theplatinum treatment of patients with platinum-resistantresistant/refractory ovarian cancer harboring a TP53 Y220C mutation to the FDA for rezatapopt in the first quarter of 2027.

Added

Management has determined that our current available cash, cash equivalents and marketable securities may not be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report, and there is substantial doubt as to our ability to continue as a going concern. For additional information, see “Note 1 — Formation and Business of the Company— Liquidity and Going Concern.”

Reworded

We plan to continue to use third-party service providers, including clinical research organizations, or CROs, and contract manufacturing organizations, or CMOs, to carry out our preclinical and clinical development and to manufacture and supply the materials to be used during the development and commercialization of our product candidates. We do not currently have a sales force.force or commercial infrastructure, and we will need to develop these capabilities, or contract with third parties to perform these functions, to commercialize any product candidate that receives regulatory approval.

Reworded

Our research and development expenses consist primarily of costs incurred to conduct research, such as the discovery and development of our product candidates as well as the development of future product candidates. Research and development expenses include personnel costs, including stock-based compensation expense, third-party contractor services, laboratory materials and supplies, and depreciation and maintenance of research equipment. We expense research and development costs as they are incurred.

Reworded

We do not allocate our costs by product candidate or development program, as a significant amount of research and development expenses include compensation costs, materials, supplies, depreciation on and maintenance of research equipment, and the cost of services provided by outside contractors, which are not tracked by product candidate or development program. In particular, with respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. Substantially all of our research and development costs are associated with our lead product candidate, rezatapopt. We initiated our Phase 1/2 PYNNACLE clinical trial in October 2020, and on that date, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In September 2025, we announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial, which was updated in October 2025 in a late-breaking oral presentation and poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. In March 2026, rezatapopt was granted ODD from the FDA for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. We plan to submit an NDA for the treatmentEnrollment of patients with platinum-resistant/refractory ovarian cancer harboringpatients afor TP53the Y220Cprimary mutationanalysis in the Phase 2 monotherapy portion of the study has been completed. We plan to thesubmit FDAour initial New Drug Application, or NDA, via accelerated approval for rezatapoptplatinum resistant/refractory ovarian cancer in the first quarter of 2027.

Reworded

Comparison of the Three Months Endedended MarchJune 31,30, 2026 and 2025

Reworded

Research and development expenses were $15.3$14.7 million for the three months ended MarchJune 31,30, 2026, compared to $17.4$18.4 million for the three months ended MarchJune 31,30, 2025. The decrease of $2.1$3.7 million, compared to the three months ended MarchJune 31,30, 2025, was primarily due to the following:

Reworded

$2.5$4.1 million decrease in research and development expenses largely driven by decreased contractualcontract research organization costs for advancing our lead product candidate, rezatapopt; offset by $0.4$0.5 million increase in personnel related costs.

Reworded

General and administrative expenses were $3.7$4.2 million for the three months ended MarchJune 31,30, 2026, compared to $4.1$4.5 million for the three months ended MarchJune 31,30, 2025. The decrease of $0.4$0.3 million, compared to the three months ended MarchJune 31,30, 2025, was primarily due to athe $0.1 million decrease in personnel expenses and a $0.3 million decrease in finance and legal support costs.following:

Added

$0.1 million decrease in personnel expenses driven by a decrease in stock-based compensation costs and $0.2 million decrease in finance support costs.

Reworded

Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents, and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $1.0$0.8 million for the three months ended MarchJune 31,30, 2026, compared to $1.9$1.7 million for the three months ended MarchJune 31,30, 2025. The decrease of $0.9 million compared to the three months ended March 31, 2025 was driven by adecreased declineaverage in interest rates combined with lower overallinvested balances in interest-bearing cash, cash equivalents, and investments in marketable securities and U.S. treasuries during the three months ended MarchJune 31,30, 2026.

Added

Comparison of the Six Months ended June 30, 2026 and 2025

Added

The following table summarizes our results of operations (in thousands):

Added

Research and Development Expenses

Added

The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):

Added

Research and development expenses were $30.0 million for the six months ended June 30, 2026, compared to $35.8 million for the six months ended June 30, 2025. The decrease of $5.8 million, compared to the six months ended June 30, 2025, was primarily due to the following:

Added

$6.5 million decrease in research and development expenses largely driven by decreased contract research organization costs for advancing our lead product candidate, rezatapopt; offset by $0.7 million increase in expenses for personnel related costs.

Added

General and Administrative Expenses

Added

General and administrative expenses were $7.9 million for the six months ended June 30, 2026, compared to $8.6 million for the six months ended June 30, 2025. The decrease of $0.7 million, compared to the six months ended June 30, 2025, was primarily due to the following:

Added

$0.6 million decrease in finance and legal support costs, and $0.1 million decrease in personnel expenses driven by a decrease in stock-based compensation costs.

Added

Interest Income, Net

Added

Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents, and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $1.8 million for the six months ended June 30, 2026, compared to $3.6 million for the six months ended June 30, 2025. The decrease of $1.8 million compared to the six months ended June 30, 2025, was driven by decreased average invested balances in marketable securities and U.S. treasuries during the six months ended June 30, 2026.

Reworded

The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell NOL carryforwards and R&D tax credits to other New Jersey-based corporate taxpayers. As of MarchJune 31,30, 2025, we received $18.4 million of cash for the NOL and R&D tax credit sales related to the tax years ended December 31, 2015 to 2023. The sale of the NOLs and R&D tax credits have been recorded as an income tax benefit within the condensed consolidated statement of operations. For the threesix months ended MarchJune 31,30, 2025, we had reached the sale limit established by the program and received a benefit for income taxes of $2.2 million. We did not receive any benefit for income taxes for the threesix months ended MarchJune 31,30, 2026.

Reworded

Since our inception, we have not generated any revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates. Even if the Company's drug development and commercialization efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. As of MarchJune 31,30, 2026, we had cash, cash equivalents, and marketable securities of $93.5$79.4 million and an accumulated deficit of $464.5$482.6 million. We have financed our operations primarily through issuance and sales of our equity securities.

Reworded

On November 20, 2024 we filed a shelf registration statement on Form S-3 (File No. 333-283349) with the SEC and a prospectus supplement, which registered the offering, issuance and sale of up to $200.0 million of various equity and debt securities and up to $113.8 million of common stock pursuant to an at-the-market equity offering program with Jefferies LLC, dated October 4, 2021, or the ATM Program. The SEC declared the registration statement effective on November 27, 2024. During the three and six months ending MarchJune 31,30, 2026, we did not sell any shares of our common stock pursuant to the ATM Program. As of MarchJune 31,30, 2026, we had approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.

Reworded

In September 2024, we signed two subleases, one for 14,201 square feet of office space at 400 Alexander Park Drive, Suite 301, in Princeton, New Jersey, to be used as our new headquarters, or the 400 Alexander Sublease, and the other for 3,205 square feet of office and laboratory space at 311 Pennington Rocky Hill in Hopewell, New Jersey, to be used for our new laboratory space, or the 311 Pennington Sublease. The 400 Alexander Sublease term extends until February 2027. Amounts related to future lease payments for the 400 Alexander Sublease as of MarchJune 31,30, 2026, totaled $0.3 million with $0.3 million to be paid within the next 12 months. In March 2026, the 311 Pennington Sublease was terminated by the sublessor and we recorded a net gain of approximately $24,$24 thousand, which was recognized in General and Administrative expense.

Reworded

Due to our significant research and development expenditures, we have generated substantial operating losses in each period since inception. We have incurred an accumulated deficit of $464.5$482.6 million through MarchJune 31,30, 2026. We expect to incur substantial additional losses in the future. For the threesix months ended MarchJune 31,30, 2026 and 2025, our cash operating expenditures were $19.7$34.3 million and $18.3$36.6 million, respectively. Based on our research and development plans, we expect that our cash, cash equivalents, and marketable securities as of MarchJune 31,30, 2026 will be sufficient to fund our planned operations until the end ofthrough the second quarter of 2027.2027, which is less than one year from the date of this Quarterly Report. As a result, management has determined that there is substantial doubt as to our ability to continue as a going concern.

Added

Our ability to continue as a going concern will depend on, among other things, our ability to obtain additional funding and appropriately manage the amount of cash used to fund our operations. We plan to address this condition through public or private equity, convertible or debt financing or capital obtained in connection with strategic collaborations or licensing or other sources. There are inherent uncertainties as the outcome of these potential transactions are outside management’s control, and therefore there are no assurances that any of these potential transactions will occur. In addition, there can be no assurances that these transactions will sufficiently improve our liquidity or that we will otherwise realize the anticipated benefits. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, suspend or curtail planned programs, or pursue strategic alternatives. Any of these actions could materially harm our business, results of operations and future prospects.

Reworded

the timing and progress of preclinical andpreclinical, clinical development and commercial preparatory activities;

Reworded

the cost and timing of regulatory approvals; and our efforts to manage our office and laboratory headquarters, enhance operational systems and hire additional personnel to support development and commercialization of our product candidates and satisfy our obligations as a public company.

Reworded

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026, was $19.7$34.3 million, which consisted primarily of net loss of $18.0$36.1 million, partially offset by non-cash charges of $1.0$2.2 million. Changes in our net operating assets and liabilities decreased operating cash by $2.7$0.4 million. The non-cash charges primarily consisted of stock-based compensation of $1.4$2.9 million, and accretion of discounts on marketable securities of $0.4$0.8 million, and depreciation of $0.1 million. The change in our net operating assets and liabilities was primarily due to a decrease in outstandingaccounts payablespayable, partially offset by an increase in accrued expenses and accrueda expenses.decrease in prepaid expenses and other assets.

Reworded

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025, was $18.3$36.6 million, which consisted primarily of net loss of $17.4$38.6 million partially offset by non-cash charges of $0.7$1.8 million. Changes in our net operating assets decreasedincreased operating cash by $1.5$0.4 million. The non-cash charges primarily consisted of stock-based compensation of $1.5$3.2 million, and accretion of discounts on marketable securities of $0.8$1.6 million, and depreciation of $0.1 million. The change in our net operating assets and liabilities was primarily due to aan decreaseincrease in prepaid expenses and other assets, anand increasea decrease in outstanding payables and a decrease in accrued expenses.

Removed

Our investing activities provided $20.8 million of cash during the three months ended March 31, 2026, which consisted primarily of maturities of marketable securities of $31.5 million, partially offset by purchases of marketable securities of $10.7 million.

Reworded

Our investing activities provided $28.7$8.6 million of cash during the threesix months ended MarchJune 31,30, 2025,2026, which consisted primarily of maturities of marketable securities of $44.4$46.0 million, partially offset by purchases of marketable securities of $15.7$37.4 million.

Added

Our investing activities provided $39.7 million of cash during the six months ended June 30, 2025, which consisted primarily of maturities of marketable securities of $86.4 million, partially offset by purchases of marketable securities of $46.7 million.

Added

Our financing activities provided $0.1 million and $0.1 million of cash during the six months ended June 30, 2026 and 2025, respectively. This consisted of $0.1 million of proceeds from the purchase of common stock under our 2020 ESPP during the six months ended June 30, 2026 and $0.1 million of proceeds from the exercise of stock options for the six months ended June 30, 2025.

Removed

For the three months ended March 31, 2026 and 2025, net cash provided by financing activities was zero.

Reworded

We believe that the accounting policies described below involve a high degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our financial condition and results of our operations. During the three-monthsix-month period ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies from those described in our audited condensed consolidated financial statements for the year ended December 31, 2025, included in our Annual Report on Form 10-K filed with the SEC on March 6, 2026, except as noted below.

Reworded

For a description of recent accounting pronouncements, see Note 2 of the notes to our unaudited condensed consolidated financial statements for the threesix months ended MarchJune 31,30, 2026 included elsewhere in this Quarterly Report on Form 10-Q.

PMVP insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

No Form 4 stock transactions in this period.

Well-known investors holding PMVP (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Two Sigma Investments COM2026-06-301,954,136$2.6M0.0%Added 4%
Citadel Advisors (Ken Griffin) COM2026-06-3047,308$63.4K0.0%Added 5%
Point72 Asset Management (Steve Cohen) COM2026-06-3020,945$26.0K—Sold out

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when PMVP files, watchlists and downloadable comparisons.