BeyondSpring Reports Second-Quarter 2026 Financial Results and Provides Corporate Update

On August 14, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the quarter ended June 30, 2026, and provided a corporate update highlighting clinical progress for Plinabulin and the Company’s leadership transition.

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"The second quarter was marked by additional clinical and scientific support for continuing Plinabulin development," said Min Qiu, Chief Executive Officer of BeyondSpring. "Updated Phase 2 data presented at ASCO (Free ASCO Whitepaper) 2026 continued to demonstrate an encouraging 58% two-year OS rate in metastatic NSCLC patients whose disease progressed after first-line immune checkpoint inhibitor (ICI) therapy. This encouraging prospective OS data strengthens our conviction in the DUBLIN-4 study, a confirmatory Phase 3 study with OS as the primary endpoint in non-squamous NSCLC post-ICI with no driver mutation, a severe unmet medical need with docetaxel as the standard of care. With our leadership transition now effective, our priorities are clear: advancing the regulatory, operational and financing preparations necessary to initiate DUBLIN-4."

Mr. Qiu continued, "The DUBLIN-4 study represents our lead clinical development priority for a potential path toward future regulatory submissions. We believe the published DUBLIN-3 results in The Lancet Respiratory Medicine, recent ASCO (Free ASCO Whitepaper) 2026 clinical data, and the AACR (Free AACR Whitepaper) 2026 ADC combination findings collectively reinforce Plinabulin’s differentiated potential as a potent dendritic cell maturation agent to improve survival benefits while mitigating treatment-limiting high-grade neutropenia in NSCLC and beyond."

Recent Clinical and Corporate Highlights of Plinabulin

ASCO 2026 (Phase 2 data): Plinabulin combination demonstrated durable response and survival benefit in post-ICI metastatic NSCLC

Presented updated efficacy and safety results from the investigator-initiated Phase 2 303 Study evaluating Plinabulin/docetaxel and pembrolizumab in 47 patients with metastatic NSCLC and acquired resistance following first-line immune checkpoint inhibitor therapy.
As of the February 28, 2026 data cutoff, median progression-free survival was 7.0 months, median duration of response was 9.3 months, disease control rate was 79.5%, and confirmed objective response rate was 18.2%.
The 12-month and 24-month overall survival rates were 78.1% and 58.0%, respectively, with median overall survival not reached after a median follow-up of 28.8 months.
The combination demonstrated a generally manageable safety profile and evidence of immune activation, including increased frequencies of activated CD4+ and CD8+ T cells as well as higher white blood cell, neutrophil, and platelet counts.
AACR 2026 (preclinical data): Improved complete response rate, overall survival and tolerability of certain antibody-drug-conjugates (ADCs)

Presented preclinical data showing that Plinabulin in combination with the approved topoisomerase I inhibitor (TOP1)-based ADCs enhanced complete tumor regression rates and/or survival of TROP-2-directed datopotamab deruxtecan or HER2-directed trastuzumab deruxtecan, with or without PD-1/PD-L1 inhibition.
Plinabulin improved tolerability in the preclinical combination models and increased the CD8+ T-cell-to-Treg ratio, supporting an immune-mediated mechanism for the enhanced anticancer activity.
The findings support Plinabulin’s potential to address limited durability and treatment-limiting hematologic toxicity associated with ADC-based therapy and broaden the scientific rationale for future ADC combination studies.
DUBLIN-4 Confirmatory Phase 3 Program

DUBLIN-4 is the Company’s planned, randomized, double-blind, 442-patient confirmatory Phase 3 study of Plinabulin plus docetaxel in non-squamous, EGFR wild-type NSCLC patients who have progressed on PD-1/PD-L1 inhibitor-containing therapies.
The program is designed to prospectively confirm the survival and tolerability benefits observed in the DUBLIN-3 Phase 3 study, which was published in The Lancet Respiratory Medicine in 2024.
BeyondSpring Leadership Transition and Corporate Execution

Effective July 1, 2026, Min Qiu was appointed Chief Executive Officer with a mandate focused on advancing DUBLIN-4, extending Plinabulin’s scientific optionality, and building BeyondSpring’s global partner and investor base. Dr. Jiangwen (Jen) Majeti was appointed Vice Chairman, strengthening Board-level governance continuity and strategic depth. Na Li was appointed Chief Financial Officer to support financial discipline, public-company reporting, financing activities, and capital markets engagement.
Dr. Lan Huang remains Co-Founder and Chairman of BeyondSpring, providing strategic vision and Board leadership, while devoting her executive focus to SEED Therapeutics, where she serves as Co-Founder, Chairman, and Chief Executive Officer.
Second Quarter Financial Results

Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended June 30, 2026, compared to $1.0 million for the quarter ended June 30, 2025. R&D expenses remained relatively flat, as a $0.3 million increase in drug manufacturing activities to prepare for potential future study initiation was substantially offset by lower patent-related professional services and personnel expenses.
General and administrative (G&A) expenses were $0.8 million for the quarter ended June 30, 2026, compared to $0.9 million for the quarter ended June 30, 2025. The $0.1 million decrease was primarily due to lower legal and consulting expenses related to accounting advisory and business development.
Net loss was $1.8 million for the quarter ended June 30, 2026, compared to $1.9 million for the quarter ended June 30, 2025.
Cash, cash equivalents, and short-term investments were $6.5 million as of June 30, 2026, compared to $12.6 million as of December 31, 2025.
Year-to-Date Financial Results

Continuing operations:

Research and development (R&D) expenses were $2.0 million for the six months ended June 30, 2026, compared to $1.9 million for the six months ended June 30, 2025. The $0.1 million increase was primarily due to higher drug manufacturing expenses, partially offset by lower patent-related professional services, regulatory filing advisory and personnel expenses.
General and administrative (G&A) expenses were $1.9 million for the six months ended June 30, 2026, compared to $2.7 million for the six months ended June 30, 2025. The $0.8 million decrease was primarily due to lower incentive compensation and share-based compensation and lower professional services expenses related to legal advisory matters.
Net loss was $4.1 million for the six months ended June 30, 2026, compared to $4.5 million for the six months ended June 30, 2025.

(Press release, BeyondSpring Pharmaceuticals, AUG 14, 2026, View Source [SID1234670120])

Silexion Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

On August 14, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported financial results for the three-month and six-month periods ended June 30, 2026, and provided a business update.

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Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "The second quarter of 2026 and the period since that time have represented the most consequential stretch in Silexion’s history, as we have transitioned SIL204 from a preclinical and regulatory-preparation asset into an active Phase 2/3 clinical program. With clinical trial authorization from Germany’s BfArM added to the previously received approval from the Israeli Ministry of Health, and the successful initiation of our first clinical site at Tel Aviv Sourasky Medical Center at the end of July, our focus has shifted entirely to clinical execution. In parallel, we continued to expand the scientific profile of SIL204 with new immuno-oncology data supporting a coordinated immune-sensitization signature across four KRAS mutations, reinforcing the rationale for future combination with anti-PD-(L)1 checkpoint inhibitors. We believe this combination of clinical, regulatory, manufacturing, and translational progress positions Silexion at the beginning of what should be a defining stretch for the Company."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the second quarter and subsequent to quarter end, we successfully executed a series of financing transactions. Most recently, we closed a public offering with gross proceeds of approximately $2.5 million. All of those transactions were designed to strengthen our balance sheet and support the transition of SIL204 into its recently initiated Phase 2/3 Clinical Trial, bringing new hope to the patients who need it most, alongside supporting compliance with applicable Nasdaq continued listing requirements."

Recent Milestones & Business Highlights

Phase 2/3 Clinical Program Advanced Across Israel and Germany, and Successfully Initiated at Tel Aviv Sourasky Medical Center: During the second quarter and subsequent to quarter end, Silexion advanced SIL204 into active Phase 2/3 clinical evaluation in locally advanced pancreatic cancer. In April 2026, the Company submitted its Clinical Trial Application to Germany’s Federal Institute for Drugs and Medical Devices (BfArM) through the EU Clinical Trials Information System, with Germany serving as Reference Member State for the European program. In June 2026, the Company received CTA approval from BfArM, accompanied by a positive opinion from the Ethics Committee of the North Rhine Medical Association, adding Germany to the previously received approval from the Israeli Ministry of Health. In May 2026, the Company initiated GMP clinical supply manufacturing of SIL204 with a leading global contract development and manufacturing organization (CDMO), further supporting the operational readiness of the program. On July 29, 2026, subsequent to quarter end, Silexion successfully initiated the Phase 2/3 clinical trial at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov"), one of Israel’s largest and most prominent academic medical centers, clearing the site to commence patient screening, with first patient dosing anticipated to follow. Additional Israeli and German trial sites are progressing through activation and are expected to join the program in the coming months.

Expanded Immuno-Oncology Profile for SIL204 – Coordinated Immune-Sensitization Signature Across Three Pathways and Four KRAS Mutations: During and subsequent to the second quarter, Silexion reported preclinical findings that extended SIL204’s therapeutic profile beyond direct anti-tumor activity into immune sensitization. In May 2026, the Company reported statistically significant upregulation of MHC-I following SIL204 treatment in human KRAS-mutant pancreatic and non-small cell lung cancer cells, supporting potential future evaluation alongside anti-PD-1 therapies including pembrolizumab (Keytruda). In August 2026, the Company reported additional statistically significant upregulation of FAS (CD95), the immune "death receptor," and downregulation of HLA-G, an established immune checkpoint, across three distinct KRAS mutations in pancreatic and non-small cell lung cancer cell lines. Taken together, these findings support a coordinated immune-sensitization signature across three key immune pathways — increased antigen presentation, restored susceptibility to immune-mediated apoptosis, and reduced immune checkpoint activity — observed across four KRAS mutations (G12D, G12V, G12C, and G12R), reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies.

Capital-Structure Actions to Support Clinical Execution and Continued Nasdaq Listing: During the second quarter and subsequent to quarter end, Silexion executed a series of financing transactions in support of the Phase 2/3 clinical program and support compliance with applicable Nasdaq continued listing requirements, including a May 2026 warrant exercise inducement transaction, ongoing sales of ordinary shares under the Company’s at-the-market facility, further partial conversions of principal under its related party promissory note, shareholder-approved successive increases in authorized share capital, and a 1-for-10 reverse share split effected on May 28, 2026. Most recently, on August 13, 2026, the Company closed a registered public offering with aggregate gross proceeds of approximately $2.5 million and net proceeds of approximately $2.1 million.

Financial Results for the Three Months Ended June 30, 2026

Research and development ("R&D") expenses for the three months ended June 30, 2026, were approximately $2.2 million, compared to approximately $1.0 million for the three months ended June 30, 2025, an increase of 120.0%. The increase resulted mainly from an increase in subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of our Phase 2/3 human clinical trial, which was initiated in July 2026.

General and administrative ("G&A") expenses for the three months ended June 30, 2026, were approximately $1.5 million, compared to approximately $1.3 million for the three months ended June 30, 2025, an increase of 15.4%. The increase resulted mainly from an increase in professional services costs, primarily related to consultants and other expenses associated with the costs of operating as a public company.

Financial expenses (income), net for the three months ended June 30, 2026, were approximately $(0.1) million of financial income, net, compared to approximately $0.2 million of financial expenses, net, for the three months ended June 30, 2025. The change was mainly due to the revaluation of the related party promissory note.

Net loss for the three months ended June 30, 2026, was approximately $3.6 million, compared to approximately $2.5 million for the three months ended June 30, 2025, an increase of 44.0%. The increase was mainly due to higher research and development expenses related to preparations for the human clinical trial initiated in July 2026, and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.

Financial Results for the Six Months Ended June 30, 2026

R&D expenses for the six months ended June 30, 2026, were approximately $3.6 million, compared to approximately $1.6 million for the six months ended June 30, 2025, an increase of 125.0%. The increase was primarily attributable to higher subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of the Company’s Phase 2/3 human clinical trial, which was initiated in July 2026.

G&A expenses for the six months ended June 30, 2026, were approximately $2.8 million, compared to approximately $2.3 million for the six months ended June 30, 2025, an increase of 21.7%. The increase resulted mainly from an increase in professional services costs, primarily related to legal, consultants, and other expenses associated with the costs of operating as a public company.

Financial expenses (income), net for the six months ended June 30, 2026, were approximately $(0.1) million of financial income, compared to approximately $0.3 million of financial expenses for the six months ended June 30, 2025. The decrease was mainly due to the revaluation of the related party promissory note.

Net loss for the six months ended June 30, 2026, was approximately $6.3 million, compared to approximately $4.2 million for the six months ended June 30, 2025, an increase of 50.0%. The increase was mainly due to higher research and development expenses (mainly related to preparations for the human clinical trial, initiated in July 2026) and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.

Balance Sheet

As of June 30, 2026, the Company had cash and cash equivalents of approximately $2.2 million, compared to approximately $6.0 million as of December 31, 2025.
During the second quarter and subsequent to quarter end, the Company strengthened its capital position through a series of financing transactions, most recently the closing on August 13, 2026, of a public offering yielding aggregate gross proceeds of approximately $2.5 million. As a result of these transactions and those detailed in the Company’s Quarterly Report on Form 10-Q, the Company estimates that its shareholders’ equity, as of June 30, 2026 (as adjusted to reflect the foregoing transactions to date), is currently approximately $3.2 million, which exceeds the Nasdaq Capital Market’s $2.5 million minimum shareholders’ equity requirement for continued listing. Accordingly, the Company believes that it has restored compliance with the applicable shareholders’ equity requirement.

(Press release, Silexion Therapeutics, AUG 14, 2026, View Source [SID1234670146])

Caribou Biosciences Reports Second Quarter 2026 Financial Results and Provides Business Update

On August 14, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the second quarter of 2026 and provided a business update.

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"At Caribou, we are redefining what patients and physicians should expect from allogeneic CAR-T cell therapy," said Rachel Haurwitz, PhD, president and CEO of Caribou. "The data presented at EHA (Free EHA Whitepaper) 2026 continue to demonstrate that a single dose of vispa-cel can produce durable responses on par with autologous CAR-T cell therapies in patients with second-line large B cell lymphoma, and a single dose of CB-011 results in deep, durable responses in high-risk patients with relapsed or refractory multiple myeloma. With our off-the-shelf approach, these programs have the potential to dramatically expand CAR-T cell therapy access for patients."

Clinical highlights

Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•In June, long-term follow-up clinical data from the ANTLER phase 1 clinical trial were presented at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting. Data presented reinforced vispa-cel is the only single-dose, off-the-shelf therapy to demonstrate deep and durable responses on par with autologous CAR-T cell therapies in second-line (2L) large B cell lymphoma (LBCL). Efficacy and safety data in 2L LBCL patients who had received a single dose of 80 million optimized vispa-cel CAR-T cells (N=27) included:
◦82% overall response rate (ORR)
◦67% complete response (CR) rate
◦17.1-month median progression-free survival (PFS)
◦Generally well-tolerated safety profile
•Optimized vispa-cel is defined as cells from a donor younger than 30 years old with at least two matched human leukocyte antigen (HLA) alleles between patient and donor. The 27-patient subgroup best represents the treatment regimen and patient population for Caribou’s planned ANTLER-3 pivotal phase 3 clinical trial.
•Caribou previously reached alignment with the U.S. Food and Drug Administration (FDA) regarding its planned ANTLER-3 pivotal phase 3 clinical trial design, which is expected to be a randomized, controlled clinical trial enrolling approximately 250 CD19-naïve 2L LBCL patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the urgent need for therapy.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•In June, longer follow-up dose escalation clinical data from the CaMMouflage phase 1 clinical trial were presented at the 2026 EHA (Free EHA Whitepaper) Annual Meeting. Data continue to demonstrate that CB-011 drives deep, durable responses after a single dose. Twelve BCMA-naïve patients were treated with the recommended dose for expansion (RDE) of 450 million CB-011 CAR-T cells after lymphodepletion. Efficacy and safety data for this cohort included:
◦92% ORR
◦83% CR or stringent CR (≥CR) rate
◦91% minimal residual disease (MRD) negativity in 10/11 evaluable patients
◦50% of patients in ≥CR at 15 months
◦Manageable safety profile
•Caribou also reported a patient case study of a 71-year-old male with r/r MM who received eight prior lines of therapy, including ciltacabtagene autoleucel, an approved autologous CAR-T cell therapy. Before entering CaMMouflage, the patient never achieved a CR following any of his post-front-line therapies. After receiving a single dose of 450 million CB-011 CAR-T cells (the RDE), the patient achieved a CR at day 28 that was maintained at month 3 and remained ongoing as of the May 26, 2026, efficacy data cutoff date.
•Caribou is enrolling BCMA-naïve and prior BCMA therapy-exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial. In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up, as well as longer follow-up data on the 12-patient, BCMA-naïve RDE cohort from dose escalation.
Second quarter 2026 financial results
Licensing and other third-party revenue: Revenue from licensing and other third-party agreements was $1.5 million for the three months ended June 30, 2026, compared to $2.7 million for the same period in 2025.

R&D expenses: Research and development expenses were $18.9 million for the three months ended June 30, 2026, compared to $27.7 million for the same period in 2025. The decrease was primarily related to decreased external contract manufacturing organization and contract research organization activities; expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025; facilities and allocated expenses; and expenses related to licenses, sublicensing revenue, and milestones.

G&A expenses: General and administrative expenses were $7.9 million for the three months ended June 30, 2026, compared to $10.4 million for the same period in 2025. The decrease was primarily due to personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025; lower legal expenses; other service-related expenses; and other facilities and allocated expenses.

GAAP net loss and net loss per share, basic and diluted: Caribou reported a GAAP net loss of $24.3 million, or $0.24 per share, basic and diluted, for the three months ended June 30, 2026, compared to $54.1 million, or $0.58 per share, basic and diluted, for the same period in 2025, which included $21.3 million in non-cash impairment charges.

Cash, cash equivalents, and marketable securities: Caribou had $113.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026, compared to $142.8 million as of December 31, 2025. Caribou now expects that its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned ANTLER-3 pivotal phase 3 clinical trial for vispa-cel, to the end of 2027. Caribou is exploring multiple options to fully fund its planned ANTLER-3 clinical trial.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. Eighty-five patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40, 80, or 120 million CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Eighty million CAR-T cells was selected as the recommended phase 2 dose (RP2D). Six patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirty-five patients were treated with a single dose of CB-011 (150 million [N=6], 300 million [N=13], 450 million [N=13], and 800 million [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The dose expansion portion of the trial is evaluating safety and efficacy of 450 million CB-011 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, AUG 14, 2026, View Source [SID1234670121])

PMV Pharmaceuticals Reports Second Quarter 2026 Financial Results and Corporate Highlights

On August 14, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"The PYNNACLE clinical trial continues to progress remarkably well, thanks to the dedication and outstanding execution of the clinical investigators, their teams, and ours," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We anticipate submitting an NDA for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027."

PYNNACLE Phase 2 Monotherapy Update:

Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial has been completed. The multicenter, single arm, registrational Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors. PMV Pharma anticipates submitting an NDA for accelerated approval of rezatapopt as a treatment for platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.

Second Quarter 2026 Financial Results

PMV Pharma ended the second quarter with $79.4 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $34.3 million for the six months ended June 30, 2026, compared to $36.6 million for the six months ended June 30, 2025.

Net loss for the quarter ended June 30, 2026, was $18.1 million compared to $21.2 million for the quarter ended June 30, 2025. The net loss decrease was primarily due to decreased contract research organization costs and reduced finance support costs.
R&D expenses were $14.7 million for the quarter ended June 30, 2026, compared to $18.4 million for the quarter ended June 30, 2025. The decrease in R&D expenses was primarily due to decreased contract research organization costs for the advancement of the rezatapopt program.
General and administrative (G&A) expenses were $4.2 million for the quarter ended June 30, 2026, compared to $4.5 million for the quarter ended June 30, 2025. The decrease in G&A expenses was primarily due to reduced personnel expenses and a decrease in finance support costs.
About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors, conducted across approximately 70 sites.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, AUG 14, 2026, View Source [SID1234670147])

Chugai Files for Additional Indication of Tecentriq for Adjuvant Treatment of MSI-High Colon Cancer

On August 14, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 840mg [generic name: atezolizumab (genetical recombination)] for an additional indication as adjuvant treatment for adults and pediatric patients with microsatellite instability-high (MSI-High) colon cancer.

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"Colorectal cancer is the most commonly diagnosed cancer in Japan, and recurrence after adjuvant chemotherapy remains a significant challenge in patients with pathological Stage III disease. In the ATOMIC trial, the addition of Tecentriq to standard adjuvant chemotherapy demonstrated a reduction in the risk of disease recurrence or death. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients with MSI-High colon cancer as a new standard of care," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the investigator-initiated global Phase III ATOMIC trial (Alliance A021502) in patients with pathological Stage III deficient mismatch repair (dMMR) colon cancer following curative resection1,2. The trial evaluated the efficacy and safety of adding Tecentriq to standard adjuvant mFOLFOX6 chemotherapy. dMMR is known to lead to MSI-High status in tumor cells.
For the primary endpoint of disease-free survival (DFS), three-year DFS rates were 86.3% (95% CI: 81.8-89.8) in the Tecentriq combination arm and 76.2% (95% CI: 70.9-80.6) in the mFOLFOX6 arm.
The Tecentriq combination arm demonstrated a statistically significant improvement compared with mFOLFOX6 alone, reducing the risk of disease recurrence or death (stratified hazard ratio: 0.50, 95% CI: 0.35-0.73; p<0.001). The most common adverse events were hepatic dysfunction (43.9%), skin disorders (33.8%), and hypothyroidism (18.8%). The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

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About the ATOMIC (NCT02912559/Alliance A021502) trial
ATOMIC is an investigator-initiated overseas Phase III trial being conducted by the Alliance for Clinical Trials in Oncology, a research group supported by the U.S. National Cancer Institute (NCI), in patients with pathological Stage III deficient mismatch repair (dMMR) colon cancer following curative resection. The trial is being conducted as an open-label, randomized trial evaluating the efficacy and safety of a standard adjuvant mFOLFOX6 treatment arm (administered for six months) and a combination treatment arm in which mFOLFOX6 plus Tecentriq is administered for six months, followed by Tecentriq monotherapy for an additional six months (12 months in total). The FDA has granted Priority Review and is expected to make a decision on the approval by 9 October 2026.

About Colorectal Cancer with Deficient Mismatch Repair (dMMR) or Microsatellite Instability-High (MSI-High)
Colorectal cancer is the most commonly diagnosed cancer in Japan, with approximately 154,000 new cases reported in 2023 (approximately 102,000 cases of colon cancer and 52,000 cases of rectal cancer) and approximately 54,000 deaths reported in 2024 (approximately 38,000 cases of colon cancer and 16,000 cases of rectal cancer)3. Among colorectal cancer cases in Japan, approximately 6-7% are reported to have deficient mismatch repair (dMMR)4,5. dMMR refers to a condition in which the DNA mismatch repair system is impaired, resulting in the development of microsatellite instability-high (MSI-High) tumors. Most tumors with dMMR exhibit MSI-High status. Because these tumors accumulate large numbers of somatic mutations and are therefore highly immunogenic, they are considered likely to respond to treatment with immune checkpoint inhibitors6,7. However, clinical evidence supporting the use of immune checkpoint inhibitors in the adjuvant treatment of colorectal cancer has been limited to date.
Adjuvant chemotherapy is recommended for patients with pathological Stage III colorectal cancer; however, recurrence is still observed in approximately 30% of patients following treatment8,9. Furthermore, prognosis remains poor once recurrent colorectal cancer progresses to an unresectable stage. Therefore, there remains a need for new adjuvant treatment options that can help reduce the risk of recurrence following curative resection.

About Tecentriq
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

(Press release, Chugai, AUG 14, 2026, View Source [SID1234670122])