1stOncology™: Cancer Intelligence Service – Page 928 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Beyond Air® Reports Fiscal Second Quarter 2026 Financial Results and Provides Corporate Update

On November 10, 2025 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, reported its financial results for fiscal second quarter ended September 30, 2025, and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"Over the past year, we have made steady progress deploying LungFit PH to hospitals across the U.S. and establishing a global distribution network. As the first and only FDA-approved tankless nitric oxide generator and delivery system that uses ambient air to produce nitric oxide on demand for hospital use, LungFit PH is delivering meaningful workflow and efficiency benefits for clinicians and hospital administrators. With the recent capital infusion, we plan to accelerate commercial execution and advance regulatory initiatives, including select international submissions and our second-generation LungFit PH. We also welcome Beyond Air Board member Bob Goodman as Interim Chief Commercial Officer to lead our commercial strategy and team transitioning from David Webster, who leaves us with our gratitude. Bob brings decades of commercial leadership across medtech and pharma, including senior roles at BioTelemetry and Philips Healthcare, and will oversee U.S. and international commercial strategy, team expansion, and channel optimization," said Steve Lisi, Chairman and Chief Executive Officer.

We are gearing up for regulatory approvals outside the US as well as the anticipated FDA approval of our second generation LungFit PH and subsequent launch before the end of calendar 2026, subject to regulatory review and clearance," concluded Mr. Lisi.

Commercial Execution, Recent Highlights and Upcoming Milestones

LungFit PH Commercial Execution
Revenue increased 128% to $1.8 million for the fiscal quarter ended September 30, 2025, compared to $0.8 million for the same period last year. Growth was driven by increased demand for LungFit PH through U.S. commercial activities.
International revenue continues to build momentum, driven by recent regulatory approvals in select markets. During the quarter, the Company expanded its global LungFit PH distribution network, including new agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador, bringing its total international coverage to 35 countries, representing a combined population of 2.8 billion people.
Appointed Robert (Bob) Goodman interim Chief Commercial Officer following the departure of David Webster. Robert, who joined the Board of Beyond Air in June 2025, has held key leadership roles at a range of high-performing organizations, including BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. His career spans public companies, private equity-backed businesses, and early-stage ventures, where he has consistently driven innovation, operational scale, and commercial success.
U.S. Patent and Trademark Office granted a patent allowance for a design patent covering the second-generation LungFit PH through 2040.
Achieves certification to demonstrate conformity of its Quality Management System with the regulatory requirements of all MDSAP participating countries, that include Australia, Brazil, Canada, European Union, Japan and United States.
The Beyond Air team will be attending the AARC Annual Congress, which is taking place December 6th to 8th in Phoenix, AZ.
Pending Regulatory Milestones
PMA supplement for the second-generation LungFit PH submitted to U.S. FDA in June 2025.
International submissions for LungFit PH remain on track with local partners.

Beyond Cancer – Solid Tumor Program – clinical stage development of an intratumoral ultra-high concentration Nitric Oxide (UNO) technology as a gas delivery of NO at high concentrations to tumors to induce an immune response.

Clinical Development Execution
Phase 1a trial (monotherapy) – Part A of the trial evaluating UNO therapy in 10 subjects with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors at a dose of 25,000 ppm has been completed.
Latest results to date from the Phase 1a trial show median overall survival (mOS) has not yet been achieved, with median survival expected to exceed 23 months.
Phase 1b trial (combination therapy) – Will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO) in subjects with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (12 weeks) after receiving a single agent anti-PD-1 containing treatment.

NeuroNOS – Autism Spectrum Disorder (ASD) Program – developing neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism spectrum disorder ("ASD") and other neurological conditions.

U.S. FDA granted Orphan Drug Designation to its investigational therapy, BA-101, for the treatment of Glioblastoma (GBM). The Company is working closely with regulators, investigators, patient groups, and foundations to accelerate development of BA-101 toward first-in-human studies.
U.S. FDA granted Orphan Drug Designation to BA-102, an investigational therapy for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with ASD. The Company is in preclinical development and expects to progress to a Phase 1 first-in-human clinical trial by the end of 2026, which could provide data in 2027.

Financing & Liquidity

Closed a promissory note and equity line of credit for up to $32 million with Streeterville Capital, LLC. The agreement provides Beyond Air with a debt agreement for $12.0 million, which does not require any payment for the first year, as well as an equity line of credit for up to $20 million, which is subject to an effective registration statement and other customary conditions. This infusion of new capital equates to a September 30, 2025 proforma cash, cash equivalents, restricted cash and marketable securities balance of $22.9 million, which is expected to provide runway into calendar 2027.

Financial Results for the Fiscal Quarter Ended September 30, 2025
Revenues for the fiscal quarter ended September 30, 2025 increased 128% to $1.8 million, compared with $0.8 million for the fiscal quarter ended September 30, 2024. Gross loss of $0.3 million was recognized for the quarter ended September 30, 2025, compared with a gross loss of $1.1 million for the quarter ended September 30, 2024. The decrease in gross loss was primarily attributed to sales growth, partially offset by one-time costs required to upgrade the Company’s existing fleet of devices and provisions for excess inventory.

Research and development expenses for the fiscal quarter ended September 30, 2025 were $2.5 million compared with $4.6 million for the fiscal quarter ended September 30, 2024. The decrease of $2.1 million was primarily attributed to a decrease in salaries, stock-based compensation costs and a reduction in Gen II device development costs.

Selling, general and administrative expenses for the quarters ended September 30, 2025 and September 30, 2024 were $4.9 million and $7.2 million, respectively. The decrease of $2.3 million was primarily attributed to a reduction in salaries and stock-based compensation costs.

Other expense for the quarter ended September 30, 2025 was $0.6 million compared with other expense of $1.2 million for the quarter ended September 30, 2024. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt.

Net loss attributed to common stockholders of Beyond Air, Inc. for the quarter ended September 30, 2025 was ($7.9) million or a loss of ($1.25) per share, basic and diluted, compared to a net loss attributed to common stockholders of Beyond Air, Inc. for the fiscal quarter ended September 30, 2024 of ($13.4) million or a loss of ($5.67) per share, basic and diluted.

Net cash burn in the fiscal quarter ended September 30, 2025 was $4.7 million.

As of September 30, 2025, the Company reported cash, cash equivalents, and marketable securities of $10.7 million, and total long-term debt outstanding was $10.1 million. An additional $2.1 million related to an insider loan was recorded as long term liabilities pending finalization of terms. Synthetic royalty related debt repayment does not begin until October 2026. Subsequent to the end of the quarter, the Company secured up to $32 million in capital through a new promissory note and equity line of credit. The new $12 million note bears a 15% interest rate and matures in 24 months, with no payments due during the first 12 months.

Financial Guidance for Fiscal Year 2026
The Company updated its revenue guidance to $8 to $10 million for the fiscal year ending March 31, 2026.

Conference Call & Webcast
Monday, November 10th @ 4:30 PM ET
Domestic: 1-877-407-0784
International: 1-201-689-8560
Conference ID: 13756730
Webcast: A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.

(Press release, Beyond Air, NOV 10, 2025, View Source [SID1234659739])

aTyr Pharma to Present at Piper Sandler 37th Annual Healthcare Conference

On November 10, 2025 aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at the Piper Sandler 37th Annual Healthcare Conference, which is scheduled to take place December 2 – 4, 2025, in New York, NY.

Details of the presentation appears below:

Conference: Piper Sandler 37th Annual Healthcare Conference
Date: Tuesday, December 2, 2025
Time: 1:00pm EST
Location: New York, NY
Format: Fireside Chat

In addition to the presentation, company management will be available to participate in one-on-one meetings with investors who are registered attendees of the conference. A webcast of the event will be available on the Investor’s section of the company’s website at www.atyrpharma.com. Following the event, a replay of the presentation will be available on the aTyr website for at least 90 days. For more information, contact [email protected].

(Press release, aTyr Pharma, NOV 10, 2025, View Source [SID1234659738])

Biohaven Reports Third Quarter 2025 Financial Results and Recent Business Developments

On November 10, 2025 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported financial results for the third quarter ended September 30, 2025, and provided a review of recent accomplishments and anticipated upcoming developments.

Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "Biohaven remains energized and focused on our mission to advance innovative medicines to patients who are waiting every day for new treatments. Our pipeline consists of multiple novel approaches for unmet medical needs and has the potential to deliver paradigm shifting treatments for conditions such as epilepsy, autoimmune disease, obesity, depression and cancer. We are particularly excited about the continued progress across our key programs and clinical-stage assets including: MoDE and TRAP degrader programs, where our two lead assets, BHV-1300 and BHV-1400, show compelling evidence to change the treatment paradigm in immune-mediated diseases; opakalim, a novel Kv7 ion channel activator, for the treatment of epilepsy and depression; and taldefgrobep alfa, myostatin-activin targeting therapy for obesity and SMA."

Dr. Coric continued, "Our late-stage clinical programs are poised to transform their respective treatment paradigms, given their novel mechanistic foundations and the body of clinical and non-clinical data generated to date. Our redirected approach to ‘right-sizing’ innovation is an important step we have undertaken to ultimately drive growth and resources to the most critical areas of our business. With this thoughtful approach to rebalancing our portfolio, we believe Biohaven remains well-positioned to execute on our commitment to transforming the treatment landscape for patients with serious and underserved diseases and we remain unwaveringly committed to delivering on our promise to advance our programs for patients, families, and shareholders in the balance of the year and in the years ahead. We will also continue to provide updates on any progress determining a path forward in SCA."

Third Quarter 2025 and Recent Business Updates

Initiated strategic cost optimization efforts across portfolio to focus forward-looking spend on three value-driving, late-stage clinical programs that will prioritize resources:
Opakalim, Kv7 ion channel activator, in pivotal studies for focal epilepsy and depression;
Lead TRAP and MoDE extracellular degraders for IgA nephropathy (BHV-1400) and Graves’ disease (BHV-1300);
Taldefgrobep alfa, myostatin-activin pathway inhibitor, for obesity and spinal muscular atrophy.
Restructuring of business priorities and optimizing resource allocation may result in either pause, delay or halting of non-priority programs.
The cost optimization efforts are expected to achieve an approximately 60% reduction in annual direct R&D spend (which excludes personnel and share-based compensation).
Expected Upcoming Milestones:

We believe Biohaven is well positioned to achieve significant, value-creating milestones in 2025 and 2026 across numerous programs:

Kv7 Activator (Opakalim):

Deliver top-line results from Phase 2 study in major depressive disorder study in 4Q 2025.
Continue two Phase 2/3 studies in focal epilepsy with initial top-line results expected in 1H 2026.
Lead TRAP and MoDE Extracellular Degraders (BHV-1400 and BHV-1300)

Continue enrollment of patients with IgAN and Graves’s disease in expanded Phase 1b and advance to pivotal studies in IgAN and Graves’ disease.
Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa):

Initiate Phase 2 clinical trial in obesity in 4Q 2025.Continue ongoing Health Authority interactions to discuss SMA registrational path in the US and Europe.
Glutamate Modulator (VYGLXIA):

We requested a Type A meeting with FDA as part of initiating an appeal process for the SCA CRL and plan to meet with the FDA to discuss potential next steps.
Capital Position:

Cash, cash equivalents, marketable securities and restricted cash as of September 30, 2025, totaled approximately $263.8 million.

Third Quarter 2024 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $141.2 million for the three months ended September 30, 2025, compared to $157.6 million for the three months ended September 30, 2024. The decrease of $16.4 million was primarily due to decreases in direct program spend, largely related to BHV-2000 and opakalim, which were partially offset by increased personnel costs including non-cash share-based compensation, as compared to the same period in the prior year. Non-cash share-based compensation expense was $13.9 million for the three months ended September 30, 2025, an increase of $6.8 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025.

General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $28.2 million for the three months ended September 30, 2025, compared to $20.6 million for the three months ended September 30, 2024. The increase of $7.7 million was primarily due to increased non-cash share-based compensation expense and increased legal costs. Non-cash share-based compensation expense was $7.6 million for the three months ended September 30, 2025, an increase of $2.6 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025.

Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $3.8 million for the three months ended September 30, 2025, compared to other income, net of $17.8 million for the three months ended September 30, 2024. The decrease of $21.6 million was primarily due to an increase in non-cash losses related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the Note Purchase Agreement), a decrease in gains recorded for the non-cash changes in the fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment), and decreased investment income.

Net Loss: Biohaven reported a net loss for the three months ended September 30, 2025 of $173.4 million, or $1.64 per share, compared to $160.3 million, or $1.70 per share, for the same period in 2024. Non-GAAP adjusted net loss for the three months ended September 30, 2025 was $155.9 million, or $1.47 per share, compared to $164.1 million, or $1.74 per share, for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

(Press release, Biohaven Pharmaceutical, NOV 10, 2025, View Source [SID1234659737])

Avidity Biosciences Reports Third Quarter 2025 Financial Results and Recent Highlights

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.

"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])

Zentalis Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Progress

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.

"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])