On November 10, 2025 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, reported financial results for the third quarter 2025 and highlighted recent operational progress.

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"We are pleased with our continued disciplined execution of the DENALI clinical trial this quarter, supporting late-stage development of azenosertib as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer, and positioning us for an anticipated topline data readout by year end 2026. Our engagement with trial investigators and presence at medical conferences is very encouraging and continues to support our development strategy," said Julie Eastland, Chief Executive Officer of Zentalis. "With $280.7 million in cash providing runway into late 2027, we maintain a robust financial foundation to deliver on our azenosertib objectives."

Business Updates

•Phase 2 DENALI clinical trial remains on track and has the potential to support an accelerated approval, subject to FDA feedback.
◦Enrollment is ongoing in DENALI Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1-positive PROC. DENALI Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule) and 300mg QD 5:2. DENALI Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results.

◦The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. We believe that DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review.

•Poster Presentations at 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) support Cyclin E1 biomarker-driven strategy for azenosertib.
◦Presentations feature data from first-in-human Phase 1 study, including Cyclin E1 biomarker findings, supporting late-stage development of azenosertib.

•TETON Phase 2 trial in uterine serous carcinoma (USC) completed enrollment.
◦Consistent with the Company’s previously announced strategic prioritization of azenosertib for the treatment of patients with Cyclin E1-positive PROC, further development in USC will be limited to partnering or the Company’s ability to allocate capital to this indication.

◦The Company will continue to support an ongoing investigator-initiated study to explore potential biomarker enrichment strategy in USC.
◦Results from the TETON trial are planned for publication in the first half of 2026.

Third Quarter 2025 Financial Results

•Cash, Cash Equivalents and Marketable Securities Position: As of September 30, 2025, the Company had cash, cash equivalents and marketable securities of $280.7 million. The Company believes that its existing cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund its operating expenses requirements into late 2027.

•Research and Development Expenses: Research and development (R&D) expenses for the three months ended September 30, 2025 were $23.0 million, compared to $36.8 million for the three months ended September 30, 2024. The decrease of $13.8 million was primarily due to decreases of $7.6 million for personnel expenses, of which $2.7 million was non-cash stock-based compensation. Decreases of $4.2 million for lab services, $1.2 million for clinical expenses, and $0.8 million for supplies, overhead, and other expense also contributed to the overall reduction in research and development expenses.

•General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2025 were $10.8 million, compared to $14.6 million during the three months ended September 30, 2024. This decrease of $3.8 million was attributable to a decrease of $3.8 million in personnel expense, of which $2.8 million was non-cash stock-based compensation.
•Operating Expenses: Total operating expenses were $33.7 million for the three months ended September 30, 2025, compared to $51.4 million for the three months ended September 30, 2024.

About Azenosertib
Azenosertib is an investigational, novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 clinical trial studying azenosertib in platinum-resistant ovarian cancer (PROC) patients. Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule). Interim results from Part 1b were presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. Part 2 is ongoing and is enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff. Part 2 includes Part 2a, a dose confirmation portion evaluating two doses, 300mg 5:2 and 400mg 5:2, and Part 2b, a portion designed to complete enrollment at the selected dose. Part 2, in total, is designed for accelerated approval, pending study outcome and discussions with the U.S. Food and Drug Administration.

(Press release, Zentalis Pharmaceuticals, NOV 10, 2025, View Source [SID1234659731])

On November 10, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that it will host a conference call and webcast tomorrow, November 11, 2025, at 8:00 a.m. ET to discuss new preliminary data from its pivotal cohort in the ongoing LEGEND trial of its novel, non-viral gene therapy candidate, detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

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The live call can be accessed by registering as a participant here. Upon registration, participants will receive conference dial-in information. A link to the live webcast of the call is available here and is also accessible on the Events and Presentations page of the Company’s Investor website: View Source A slide deck to accompany the call will be posted to the Events and Presentations page approximately 30 minutes prior to the start of the conference call. A replay of the webcast will be available on the Company’s website for one year.

(Press release, enGene, NOV 10, 2025, View Source [SID1234659751])

On November 10, 2025 Agenus Inc. (Nasdaq: AGEN) reported quarterly results for the period ended September 30, 2025, and provided a business update. Highlights include government‑funded, reimbursed compassionate access (AAC) in France for botensilimab plus balstilimab (BOT/BAL), new survival data presented at ESMO (Free ESMO Whitepaper) and ESMO (Free ESMO Whitepaper)‑GI across more than 400 patients spanning more than five refractory cancers, and initiation of the global Phase 3 BATTMAN trial.

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Access & Regulatory

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France authorizes reimbursed AAC for BOT/BAL. In September, France’s medicines agency (ANSM) authorized reimbursed compassionate access (Accès Compassionnel, AAC) for BOT/BAL in refractory MSS mCRC without active liver metastases—the first government-funded access for this population and the first reimbursed access provided for BOT/BAL by a regulatory agency. link

Clinical Highlights

BOT/BAL has demonstrated durable, long-term survival in patients with advanced solid tumors, reinforcing its potential to expand the reach of immunotherapy to those historically unresponsive to treatment.

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MSS metastatic colorectal cancer (ESMO‑GI 2025): In 123 heavily pretreated MSS mCRC patients without active liver metastases, BOT/BAL achieved 42% two‑year overall survival (OS) and 20.9‑month median OS. Median OS benchmarks in this third‑line‑plus setting is 8-14 months with current standards of care. link
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Pan‑tumor cohort (ESMO 2025): Updated Phase 1b results in >400 patients demonstrated 39% two‑year OS across more than five refractory cancers, including colorectal, ovarian, sarcoma, lung, and hepatocellular tumors. Important to note that responses were seen after prior checkpoint inhibitor failure; immune‑related AEs were treatable and reversible. link

Phase 3 Program

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Global registrational trial initiated. The BATTMAN (CCTG CO.33) Phase 3 trial conducted with the Canadian Cancer Trials Group and supported by AGITG (Australasia), and PRODIGE (France)—is launching in Q4 2025 across 100+ sites in Canada, France, Australia, and New Zealand to evaluate BOT/BAL versus best supportive care in refractory, unresectable MSS/pMMR colorectal cancer. link

Q3 2025 Financial Highlights

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Zydus transactions: In October, Agenus and Zydus agreed to a $10 million bridge facility ahead of the anticipated $91 million upon closing of the transaction which also includes an equity investment at $7.50 per share.

•
MiNK deconsolidation: In July 2025, Agenus’ ownership of MiNK fell below 50%, resulting in deconsolidation in Q3 2025. This generated approximately $100.9 million gain, resulting in net income for the three‑month and nine-month period ended September 30, 2025.

Upcoming Catalysts

•
BATTMAN patient enrollment to commence before year-end 2025
•
BOT/BAL paid access programs: government reimbursed in France and self-pay in several European countries as well as other regions – patients currently under treatment in both pathways.
•
Investigator‑initiated trials: Neoadjuvant and frontline data updates expected 1H 2026
•
France AAC: Will generate real world evidence

Webcast and Conference Call Information

As part of Agenus’ newly launched webcast series, the Company will host a Stakeholder Briefing Webcast in late November, featuring internal and external experts. Additional details will be announced prior to the event.

(Press release, Agenus, NOV 10, 2025, View Source [SID1234659700])

On November 10, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported an update on recent progress with its IMNN-001 development program for the treatment of newly diagnosed advanced ovarian cancer, including a review of positive data from the Company’s Phase 2 OVATION 2 Study and the minimal residual disease (MRD) study conducted in partnership with Break Through Cancer. The program will also include updates on trial activation and patient enrollment in the Company’s ongoing Phase 3 OVATION 3 pivotal trial.

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"IMNN-001 represents a potential landmark breakthrough in the treatment of newly diagnosed ovarian cancer in combination with standard of care chemotherapy. Data thus far indicate that our novel immunotherapy has the potential to represent a major advance in treatment that can make a meaningful difference in the lives of thousands of women," said Stacy Lindborg, Ph.D., President and CEO of IMUNON. "No other frontline ovarian cancer treatment has shown improvement in overall survival, which of course is the ultimate goal. We are very encouraged to see results from our Ovation 2 Study demonstrate that IMNN-001 treatment plus chemotherapy is associated with a 13-month improvement in overall survival with a highly favorable benefit-risk profile. The results from this landmark trial strongly support the advancement of IMNN-001 into our Phase 3 trial. We are excited to share the latest updates in today’s event and to review what’s ahead for this program."

R&D Day Featured Speakers and Program Highlights:

Premal H. Thaker, M.D., Washington University School of Medicine, will discuss the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She will highlight the data from the Phase 2 OVATION 2 clinical trial, with results including:
Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.
Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, will discuss safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including:
Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that clearly show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data further supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting.
Giorgio Paulon, Ph.D., Berry Consultants, LLC, will review the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He will highlight the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on interim analyses of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

Douglas V. Faller, M.D., Ph.D., IMUNON, will share new data further demonstrating that IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He will share the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.
A live webcast of the event and presentation materials will be available on the "Scientific Presentations" page of the IMUNON website at View Source

(Press release, IMUNON, NOV 10, 2025, View Source [SID1234659716])

On November 10, 2025 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs) to profoundly improve people’s lives, reported financial results for the third quarter ended September 30, 2025, and highlighted recent progress.

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"In October, we announced that Avidity entered into a definitive merger agreement with Novartis, which we believe maximizes value for our investors, accelerates the global reach of our innovative neuroscience pipeline, and advances even more possibilities for our innovative science," said Sarah Boyce, president and chief executive officer of Avidity. "This important transaction, alongside compelling del-zota data and a successful pre-BLA meeting with the FDA in the third quarter, underscores the remarkable consistency of our AOC platform and the significant potential of del-zota, del-desiran, and del-brax to transform outcomes for people living with serious rare diseases. These achievements are possible because of our incredibly talented Avidity team and the close collaboration of the dedicated patient and clinical communities we serve."

Company Announcements, Highlights and Upcoming Milestones

▪Definitive Merger Agreement with Novartis AG

•In October 2025, Avidity announced it had entered into a definitive merger agreement with Novartis AG ("Novartis") which was unanimously approved by the Boards of Directors of both Avidity and Novartis. The closing of the acquisition will follow the separation of Avidity’s early-stage precision cardiology programs into SpinCo, which is expected to be a publicly traded company. SpinCo will be led by Kathleen Gallagher, currently Avidity’s chief program officer, as chief executive officer. Sarah Boyce, currently Avidity’s chief executive officer, will serve as chair of the board.
•Novartis will acquire Avidity’s programs and pipeline in neuroscience and gain access to its differentiated RNA-targeting delivery platform, which includes three late-stage clinical development programs: delpacibart zotadirsen (del-
zota) for the treatment of Duchenne muscular dystrophy (DMD), delpacibart etedesiran (del-desiran) for the treatment of myotonic dystrophy type 1 (DM1) and delpacibart braxlosiran (del-brax) for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
•Expected closing is in the first half of 2026, subject to completion of the separation of SpinCo from Avidity and other customary closing conditions.
▪Delpacibart zotadirsen (del-zota) for the treatment of people living with Duchenne muscular dystrophy with mutations amenable to exon 44 skipping (DMD44):
•Clear path forward aligned with FDA following October 2025 pre-BLA meeting. The BLA submission is planned for 2026 for accelerated approval.
•In September 2025, Avidity shared positive topline and functional del-zota data from EXPLORE44 and EXPLORE44-OLE trials demonstrating consistent, clinically meaningful improvements across functional endpoints at approximately one year of treatment. Data demonstrated reversal of disease progression and unprecedented improvement compared to baseline and natural history across multiple functional measures. Del-zota continued to demonstrate a favorable long-term safety and tolerability profile.
•In July 2025, Avidity announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to del-zota.
▪Delpacibart etedesiran (del-desiran) for the treatment of myotonic dystrophy type 1 (DM1):
•In July 2025, Avidity announced completion of enrollment for the Phase 3 HARBOR trial, the first global Ph3 trial of del-desiran for the treatment of DM1.
•Expected publication of data analyses from the completed Phase 1/2 MARINA trial in the fourth quarter of 2025.
•54-week topline data readout from global Phase 3 HARBOR study expected in the second half of 2026.
▪Delpacibart braxlosiran (del-brax) for the treatment of facioscapulohumeral muscular dystrophy (FSHD):
•Topline data from FORTITUDE biomarker cohort expected in the second quarter of 2026.
•Alignment with FDA on accelerated and full approval pathways for del-brax, and initiated global, confirmatory Phase 3 study, FORTITUDE-3, intended to support global approval strategy for del-brax.
•Phase 3 FORTITUDE-3 readout and global regulatory submissions expected in 2028.

▪Collaboration Progress:
•In the third quarter of 2025, Avidity received collaboration revenue of a $10.0 million clinical development milestone under Avidity’s research collaboration and license agreement with Eli Lilly and Company.
Third Quarter 2025 Financial Results

▪Cash, cash equivalents and marketable securities totaled approximately $1.9 billion as of September 30, 2025, which reflects net proceeds of $651.4 million from a public offering and $185.5 million from the sale of common stock under the Company’s sales agreement.

•The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2025, will be sufficient to fund its operations to mid-2028.

▪Collaboration revenues of $12.5 million for the third quarter of 2025 and $17.9 million for the first nine months of 2025, primarily relate to a $10.0 million clinical development milestone under Avidity’s research collaboration and license agreement with Eli Lilly and Company, as well as additional revenues under Avidity’s research collaboration and license agreement with Bristol Myers Squibb. Collaboration revenues of $2.3 million for the third quarter of 2024 and $7.9 million for the first nine months of 2024, primarily relate to revenues under Avidity’s research collaboration and license agreement with Bristol Myers Squibb.

▪Research and development expenses for the third quarter of 2025 were $154.9 million, compared to $77.2 million for the same period of 2024. Research and development expenses for the nine months ended September 30, 2025 were $392.6 million, compared to $208.0 million for the same period of 2024. The increases were primarily driven by increased costs associated with the advancement of del-desiran, del-brax and del-zota, higher manufacturing costs, and higher personnel costs.

▪General and administrative expenses for the third quarter of 2025 were $46.3 million, compared to $23.3 million for the same period of 2024. General and administrative expenses for the nine months ended September 30, 2025 were $116.8 million, compared to $57.9 million for the same period of 2024. The increases were primarily due to higher personnel and commercial infrastructure costs to support the company’s expanded operations.

(Press release, Avidity Biosciences, NOV 10, 2025, View Source [SID1234659735])