On November 12, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that members of company management will participate in the following investor events:

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Jefferies London Healthcare Conference
Format: Hybrid presentation (slides & moderated Q&A) and one-on-one investor meetings
Presentation Date/Time: Wednesday, November 19, 2025, at 4:00 PM GMT
Location: London, UK

37th Annual Piper Healthcare Conference
Format: One-on-one investor meetings
Date: December 2-4, 2025
Location: New York, NY

A live webcast of the Jefferies event can be accessed by visiting the "For Investors" page on the Tyra Biosciences website and will be available for replay following the event.

(Press release, Tyra Biosciences, NOV 12, 2025, View Source [SID1234659848])

On November 12, 2025 BostonGene, developer of the leading AI foundation model for cancer and the immune system, and Kyoto University, a research institution known for its groundbreaking advancements in medicine and science reported a research collaboration to develop advanced biological signatures to enhance targeted treatment strategies for patients with esophageal squamous cell carcinoma (ESCC).

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This research will leverage BostonGene’s AI-powered, multi-scale, omnimodal platform to analyze tumor molecular profiles and assess their correlation with response to a novel immune checkpoint inhibitor (ICI) and chemoradiotherapy (CRT) combination therapy. The study builds on the NOBEL trial, an investigator-initiated clinical study led by Dr. Manabu Muto of Kyoto University, by integrating genomic and transcriptomic profiling from ESCC patients to identify immune-related biomarkers that drive drug development, optimize clinical trial design and enable more accurate patient stratification.

As part of the collaboration, Kyoto University will provide clinical samples and patient data and BostonGene will apply its AI-powered molecular analytics to uncover key biological pathways and associated biomarkers influencing treatment response.

"This collaboration will generate actionable insights into the tumor microenvironment and immune landscape of esophageal cancer," said Yukimasa Shiotsu, PhD, President of BostonGene Japan. "Combining Kyoto University’s clinical expertise and BostonGene’s AI-powered analytics, we will refine and advance precision treatment strategies for ESCC patients."

"Understanding the molecular and immune characteristics of ESCC is essential for developing more effective treatment strategies," said Dr. Manabu Muto, Professor at Kyoto University and Principal Investigator of the NOBEL trial. "Through this collaboration, we will apply cutting-edge AI-powered analytics to clinical data, enabling us to identify biomarkers that can directly inform treatment decisions and improve patient outcomes."

About NOBEL trial

NOBEL trial is a Phase II study evaluating the efficacy and safety of a combination treatment of chemoradiotherapy and an immune checkpoint inhibitor for advanced esophageal cancer.

The NOBEL trial is being conducted as an investigator-initiated trial with financial support from Ono Pharmaceutical Co., Ltd.

(Press release, BostonGene, NOV 12, 2025, View Source [SID1234659864])

On November 12, 2025 GenScript reported financial results for the third quarter ended 30 September 2025.

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(Press release, GenScript, NOV 12, 2025, View Source [SID1234661837])

On November 12, 2025 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 third quarter ended September 30, 2025, and provided a corporate update.

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"I am incredibly proud of our team and their commitment to rapidly and efficiently advancing the PYNNACLE study," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We are excited by the data emerging from this study and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer."

Corporate Highlights

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Updated clinical results from the Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt were featured in late-breaking oral and poster presentations at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on October 24, 2025.
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Confirmed responses were observed in patients whose tumors were TP53 Y220C mutated and KRAS wild-type in eight tumor types including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma.
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Overall response rate (ORR) of 34% (35/103 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses. The cohort-specific ORRs were as follows:
§ Ovarian cancer: 46% ORR (22/48 patients, including one confirmed complete response, 18 confirmed partial responses, and three unconfirmed partial responses [uPR])

§ Breast cancer: 17% ORR (2/12 patients)

§ Endometrial cancer: 60% ORR (3/5 patients, including one uPR)

§ Lung cancer: 21% ORR (4/19 patients, including one uPR)

§ Other solid tumors: 21% ORR (4/19 patients)

o Across all cohorts, the median time to response was 1.3 months and the median duration of response was 7.6 months. In the ovarian cancer cohort, the median time to response was 1.3 months and median duration of response was 8.0 months.

o Post the September 4, 2025 data cutoff date, four uPRs were confirmed and one uPR (ovarian cancer) remains on treatment.

o A poster entitled "Natural history and prognostic value of TP53 Y220C mutation in advanced solid tumors: A real-world study," was also presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) which concluded that patients with TP53 Y220C-mutated solid tumors had poor prognoses and reduced overall survival compared to patients without a TP53 Y220C mutation.

Third Quarter 2025 Financial Results

PMV Pharma ended the third quarter with $129.3 million in cash, cash equivalents, and marketable securities, compared to $148.3 million as of June 30, 2025. Net cash used in operations was $56.4 million for the nine months ended September 30, 2025, compared to $34.6 million for the nine months ended September 30, 2024.

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Net loss for the quarter ended September 30, 2025, was $21.1 million compared to $19.2 million for the quarter ended September 30, 2024. The net loss increase was primarily due to increased research and development (R&D) costs.
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R&D expenses were $18.2 million for the quarter ended September 30, 2025, compared to $16.9 million for the quarter ended September 30, 2024. The increase in R&D expenses was primarily due to increased contractual research organization costs for the advancement of the rezatapopt program.
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General and administrative (G&A) expenses were $4.3 million for the quarter ended September 30, 2025, compared to $4.9 million for the quarter ended September 30, 2024. The decrease in G&A expenses was primarily due to reduced spend for stock-based compensation and facility and operational expenses.

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.

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 and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, NOV 12, 2025, View Source [SID1234659826])

On November 12, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the third quarter of 2025.

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Total revenue in the third quarter grew 26% year-over-year to $36.2 million, and Galleri revenue grew 29% year-over-year to $32.8 million. U.S. Galleri revenue was $32.6 million, representing 28% growth year-over-year. Net loss for the quarter was $89.0 million. Gross loss was $13.7 million. Non-GAAP adjusted gross profit was $20.0 million, and non-GAAP adjusted EBITDA was $(71.7) million.1

"We remain very pleased by Galleri’s commercial uptake with 39% growth in Galleri test volume in the third quarter. Our teams continue to build awareness of Galleri among providers and patients, and recent data from our registrational PATHFINDER 2 study adds to the evidence base," said Bob Ragusa, Chief Executive Officer at GRAIL. "We have also made key recent strides in opportunities beyond the U.S., led by our strategic collaboration with Samsung to bring Galleri to key Asian markets, as well as Galleri’s commercial introduction in Canada. Looking ahead, we anticipate completing our PMA submission for Galleri to the FDA in the first quarter of 2026."

For the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $36.2 million, an increase of $7.5 million or 26%.
Net loss: Net loss was $89.0 million, an improvement of $36.7 million or 29%.
Gross loss: Gross loss was $13.7 million, an improvement of $8.5 million or 38%.
Adjusted gross profit1: Adjusted gross profit was $20.0 million, an increase of $8.2 million or 69%.
Adjusted EBITDA1: Adjusted EBITDA was $(71.7) million, an improvement of $36.5 million or 34%.
Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled $547.1 million as of September 30, 2025.
Recent business highlights include:

Positive results from PATHFINDER 2 and SYMPLIFY studies add to the evidence base for the effectiveness of multi-cancer early detection.
Positive detailed performance and safety results from the pre-specified analysis of the first approximately 25,000 participants in the registrational PATHFINDER 2 study were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") Congress 2025 in October:
Adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year
Galleri detected approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations)
Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options
More than half of the new cancers detected by Galleri were stage 1 or 2 and more than two-thirds were detected at stages 1-3
Galleri positive predictive value ("PPV"), or the likelihood of receiving a cancer diagnosis following a positive test result, was 61.6%
Specificity was 99.6%, translating to a false positive rate of 0.4%
Cancer signal of origin accuracy was 92%, leading to efficient diagnostic workups
Diagnostic resolution took a median of 46 days, and only 0.6% of all participants had an invasive procedure and invasive procedures were two times more common in participants with cancer than in those without
No serious, study-related adverse events were reported
Positive long-term results from an extended registry follow-up of the SYMPLIFY study with the University of Oxford were presented at the Early Detection of Cancer Conference ("EDCC") in October. A previous primary analysis, published in The Lancet Oncology, followed participants until diagnostic resolution or up to nine months and demonstrated Galleri’s PPV was 75.5%. Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales.
The updated analysis presented at EDCC showed that approximately one-third of participants initially believed to have a false positive result were later diagnosed with cancer during the subsequent follow up period
This reduction in false positives resulted in an increase of Galleri’s PPV in this symptomatic population to 84.2%
Announced a collaboration with Medcan, a global leader in proactive health and wellness services, to provide access to the Galleri test at Medcan’s clinics. Additionally, Manulife Canada announced it now offers access to Galleri, in partnership with Medcan, to eligible life insurance customers through its innovative Manulife Vitality program.
Announced a strategic collaboration with Samsung in October to bring the Galleri test to key Asian markets. Subject to execution of definitive agreements, the parties will work as exclusive partners to commercialize Galleri in Korea, and possibly other key Asian markets, including Japan and Singapore. In addition, the parties intend to explore potential additional strategic and operational collaborations. Samsung has also agreed to make an equity investment of $110 million in GRAIL, subject to closing conditions.
Completed a private placement of equity in October resulting in gross proceeds of approximately $325 million, before deducting placement agents’ fees and other expenses. Including proceeds from this transaction, GRAIL’s cash position of more than $850 million provides runway into 2030.

(Press release, Grail, NOV 12, 2025, View Source [SID1234659849])