On August 6, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, reported financial results and business highlights for the second quarter ended June 30, 2026.

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"The second quarter marked an important period of scientific and clinical validation for γδ T cell therapeutics and IN8bio. Our γδ TCE platform is progressing, with INB-619 advancing into initial animal models. We are pleased to remain on track for reporting initial in vivo data this year," said William Ho, Chief Executive Officer and co-founder of IN8bio. "In addition, peer-reviewed and updated clinical data from our glioblastoma program continue to demonstrate a favorable safety profile and provide strong evidence that γδ T cells are clinically active and can be delivered safely to potentially improve patient outcomes. We remain focused on disciplined execution, as we continue to seek a regulatory pathway for our glioblastoma program, with the ultimate goal of bringing much needed treatment to patients."

Advancing Next-Generation γδ TCE Platform (INB-619)

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Continued advancement of proprietary INB-600 platform of novel γδ T cell engagers, designed to selectively eliminate targets such as CD19, potentially reducing toxicities including cytokine release syndrome (CRS) and infections, while expanding the therapeutic window compared with conventional CD3-targeting T cell engagers.

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Advancing INB-619, a CD19-targeting γδ T cell engager for oncology and autoimmune diseases, into IND-enabling studies following encouraging early preclinical data demonstrating complete B cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release, including IL-6 and TNF-α.
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Remain on track to report initial in vivo preclinical data in the second half of 2026.
Reported Clinical and Translational Advances for DeltEx DRI in Newly Diagnosed Glioblastoma

During the second quarter, IN8bio reported multiple clinical and scientific milestones supporting the clinical activity of γδ T cells and IN8bio’s DeltEx DRI platform:

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Published the first peer-reviewed clinical results of DeltEx DRI in newly diagnosed GBM in The Journal of Clinical Oncology. Among all patients treated, no dose-limiting toxicities (DLTs), CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.
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Presented updated clinical data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating encouraging survival benefit in repeat-dose treated patients, with mPFS of 13.0 months versus 6.6 months for contemporaneously enrolled patients receiving only standard-of-care (SOC) and mOS exceeding 19.5+ months versus 13.2 months for SOC.
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Approximately 43% of repeat-dose patients remained alive at 24 months compared with 20% of SOC patients.
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Presented new translational data at the International Society for Cell & Gene Therapy (ISCT) and International Society for Cell & Gene Therapy (ISCT) and American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meetings integrating artificial intelligence (AI), immunogenomics, histopathology, transcriptomics and spatial proteomics. Repeated DeltEx DRI dosing demonstrated preserved immune function during chemotherapy and positively remodeled the glioblastoma tumor microenvironment.
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Spatial proteomics analyses demonstrated an 18-fold increase in intratumoral CD8+ T cell density and a 90% reduction in immunosuppressive granulocytes, providing mechanistic support for the clinical activity observed with DeltEx DRI.

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IN8bio Chief Scientific Officer Lawrence Lamb co-authored a review in Nature Communications highlighting advances in γδ T cell engineering, γδ T cell engagers, CAR γδ T cells and combination immunotherapy strategies, reinforcing IN8bio’s scientific leadership in the rapidly expanding γδ T cell field.
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The publication highlights the potential of "off-the-shelf" γδ T cell therapies, driven by the cells’ lack of graft-versus-host disease (GvHD), and the growing clinical evidence supporting their application across hematologic malignancies and solid tumors, including GBM.
Upcoming Anticipated Milestones

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Report initial preclinical animal data for INB-619 in the second half of 2026.
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Report on FDA discussions regarding the potential regulatory pathways for the DeltEx DRI GBM program.
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INB-100 program clinical update at a scientific meeting in late 2026.
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Provide additional clinical and translational updates from the DeltEx DRI GBM program.
Second Quarter 2026 Financial Highlights

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Cash position: As of June 30, 2026, the Company had cash of $18.0 million, compared with $13.2 million, for the comparable prior year period.
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Research and Development (R&D) expenses: R&D expenses were $2.5 million for the three months ended June 30, 2026, compared with $2.5 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation.
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General and administrative (G&A) expenses: G&A expenses were $2.4 million for the three months ended June 30, 2026, compared with $2.7 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation.
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Net loss: The Company reported a net loss of $4.8 million, or $0.25 per basic and diluted common share, for the three months ended June 30, 2026, compared with a net loss of $5.1 million, or $1.24 per basic and diluted common share, for the comparable prior year period.

(Press release, In8bio, AUG 6, 2026, View Source [SID1234669828])

On August 6, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, reported a business update and announced second quarter 2026 financial results.

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"Following quarter end, we announced our proposed merger with Avere Therapeutics, together with Avere’s concurrent private financing expected to generate approximately $320 million in gross proceeds, and we are working toward a closing in the second half of 2026. In parallel, we are preserving capital in support of that closing. Our team continues to support the ongoing clinical programs and obligations to our partners, and opportunities to preserve value for our shareholders," said Michael Richman, President and CEO of NextCure.

Recent Business Highlights

● Announced a definitive merger agreement with Avere Therapeutics in an all-stock transaction. Upon closing, the combined company is expected to operate as Avere Therapeutics and trade on Nasdaq under the ticker symbol "AVRX". Existing NextCure stockholders are expected to receive contingent value rights ("CVRs") tied to certain legacy NextCure assets. Concurrently, Avere Therapeutics entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing of the merger, subject to customary closing conditions.
● Entered into a Transition and Continuation Agreement with LigaChem Biosciences ("LigaChem") under which LigaChem has elected to continue the development of LNCB74 as the "Sole Developing Party" pursuant to the terms under the parties’ November 2022 Research Collaboration and Co-Development Agreement. NextCure, according to these agreements, remains eligible to receive future milestone and royalty payments for the development and commercialization of LNCB74.
● Advanced restructuring initiatives to reduce operating expenses, including facility footprint reductions and the sale of certain manufacturing, laboratory and facility-related assets in preparation for completion of the merger.
● Initiated efforts to preserve value of SIM0505 and our current clinical and pre-clinical assets for our shareholders.
Financial Results for the Quarter Ended June 30, 2026

● Cash, cash equivalents, and marketable securities as of June 30, 2026 were $20.1 million as compared to $41.8 million as of December 31, 2025. The decrease of $21.7 million was primarily due to cash used to fund operations of $23.1 million, partially offset by proceeds of $1.2 million from equity sales under our existing ATM program. In connection with the proposed merger with Avere Therapeutics and related restructuring activities, NextCure is focused on preserving capital, completing the proposed transaction and pursuing efforts to preserve value of our current clinical and pre-clinical assets.
● Research and development expenses were $7.4 million for the three months ended June 30, 2026, as compared to $24.1 million for the three months ended June 30, 2025. The decrease of $16.7 million was due to $17.0 million of license fees incurred in the prior year that did not occur in the current year.
● General and administrative expenses were $2.6 million for the three months ended June 30, 2026, as compared to $3.2 million for the three months ended June 30, 2025. The decrease of $0.6 million was primarily related to lower personnel related costs.
● Asset impairment costs associated with our recently announced restructuring initiatives to reduce our footprint and sell certain facility and laboratory assets totaled $5.1 million in the second quarter.
● Net loss was $14.9 million for the three months ended June 30, 2026, as compared to a net loss of $26.8 million for the three months ended June 30, 2025. The lower net loss for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 was driven by the lower research and development and general and administrative expenses mentioned above, partially offset by impairment costs of $5.1 million and lower other income, net, of $0.3 million.
About the Merger

On July 14, 2026 NextCure announced a definitive merger agreement with Avere Therapeutics, a privately held biotechnology company developing oral therapies for IL-23-driven inflammatory diseases, in an all-stock transaction. Concurrently with the merger agreement, Avere entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing, subject to customary closing conditions. Upon closing, the combined company is expected to operate as Avere Therapeutics and trade on Nasdaq under the ticker symbol "AVRX." Following completion of the merger, the combined company will be led by Avere’s management team and governed by a board of directors constituted in accordance with the merger agreement. Existing NextCure stockholders are expected to retain an ownership interest in the combined company and receive CVRs tied to the potential future value of specified legacy NextCure

assets. The transaction is expected to close in the second half of 2026, subject to stockholder approval and other customary closing conditions.

About SIM0505

SIM0505 is an investigational antibody-drug conjugate (ADC) targeting CDH6 and incorporating a proprietary topoisomerase I inhibitor payload. On July 14, 2026, the Company announced it had informed all U.S. clinical trial sites to stop screening, consenting, and enrolling new patients and that it no longer intends to expand the clinical site footprint. The Company is seeking opportunities to preserve the value of SIM0505 for our shareholders.

About LNCB74

LNCB74 is a novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and MMAE payload. Following execution of a Transition and Continuation Agreement with LigaChem, LigaChem has elected to continue the program as Sole Developing Party. NextCure is providing transition support to facilitate the transfer of program-related activities and ongoing clinical trial operations. Pursuant to the November 2022 LigaChem Agreement, NextCure remains eligible to receive future development, regulatory and commercial milestone payments and royalties.

(Press release, NextCure, AUG 6, 2026, View Source [SID1234669824])

On August 6, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported financial results for the quarter ended June 30, 2026, and provided a business update.

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"During the second quarter we continued to execute across our clinical portfolio while preparing for multiple upcoming milestones," said David Campbell, Ph.D., President and Chief Executive Officer of Janux. "Enrollment continues across our prostate cancer programs, including JANX007 and JANX014, and we remain on track to initiate clinical development of JANX013 later this year. We also continue to make progress with JANX011 in healthy volunteers as we advance our autoimmune disease pipeline."

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical & Pipeline Progress

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JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients.
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An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC.
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JANX014 (PSMA-TRACTr), a double-masked tumor-activated T cell engager, continues enrollment in its Phase 1 clinical study designed to evaluate safety, pharmacokinetics and preliminary antitumor activity.
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JANX011 (CD19-ARM) continues enrolling in its Phase 1 clinical trial in healthy volunteers.
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The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development.

Upcoming Milestones

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Initial clinical data from the Phase 1 healthy volunteer study of JANX011 expected to be announced in the second half of 2026.
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Clinical initiation of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, expected in the second half of 2026.

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Additional clinical data for JANX007 expected to be announced at a future medical congress in the first half of 2027.

SECOND QUARTER 2026 FINANCIAL RESULTS:

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Cash and cash equivalents and short-term investments: As of June 30, 2026, Janux reported cash and cash equivalents and short-term investments of $970.9 million, compared to $966.6 million on December 31, 2025.
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Research and development expenses: Research and development expenses were $31.0 million for the quarter ended June 30, 2026, compared to $34.7 million for the comparable period in 2025.
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General and administrative expenses: General and administrative expenses were $11.0 million for the quarter ended June 30, 2026, compared to $10.5 million for the comparable period in 2025.
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Net loss: Net loss was $22.0 million for the quarter ended June 30, 2026, compared to $33.9 million for the comparable period in 2025.

(Press release, Janux Therapeutics, AUG 6, 2026, View Source [SID1234669822])

On August 6, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the second quarter ended June 30, 2026.

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"We believe soquelitinib, our oral, selective ITK inhibitor, is well positioned as a potential new treatment paradigm for patients across a broad range of diseases, based on a novel mechanism that rebalances the immune system," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are focused on driving enrollment in our registrational Phase 3 relapsed/refractory PTCL and Phase 2 atopic dermatitis trials, and we are working closely with our partner in China, Angel Pharmaceuticals, on their Phase 1b/2 atopic dermatitis trial. With planned studies in hidradenitis suppurativa and asthma anticipated to be initiated later this year, we are steadily building a body of clinical evidence that we believe demonstrates the breadth of soquelitinib’s potential across the large immunology and inflammation market."

Business Update and Strategy

Soquelitinib for Immune Diseases

Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis were presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting. The data demonstrated safety and positive efficacy results, including in patients who received prior systemic therapy and were treatment resistant. In addition, there was a dose dependent efficacy trend in cohorts 1-3, and additional clinical benefit was observed with longer treatment in cohort 4. Immunologic and biomarker data from the study supports the potential of ITK inhibition with soquelitinib to increase persistent Treg cells and influence multiple inflammatory pathways.
Corvus is enrolling patients in the SIERRA1 Phase 2 randomized, blinded, placebo-controlled atopic dermatitis clinical trial. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment. The primary endpoint of the trial is the percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12.
Angel Pharmaceuticals (Angel Pharma), Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will be enrolled in the Phase 2 portion of the study. The trial is open at several leading dermatology centers in China who have been involved in global registration trials. The study is conducted in close collaboration with Corvus. Results from cohort 1 (100 mg twice per day, 200 mg once per day and placebo) are anticipated late this year.
Corvus invested $5.0 million in a $13.5 million equity financing for Angel Pharma. The funding is anticipated to support Angel Pharma’s ongoing Phase 1b/2 trial of soquelitinib for atopic dermatitis and a new Phase 2 trial of soquelitinib for asthma. Angel Pharma anticipates that it will initiate the Phase 2 asthma trial in early 2027.
Corvus plans to initiate a Phase 1b clinical trial evaluating soquelitinib in patients with hidradenitis suppurativa and a Phase 2 trial evaluating soquelitinib in patients with asthma, later this year.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.

Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy.

Financial Results
As of June 30, 2026, Corvus had cash, cash equivalents and marketable securities of $215.2 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of June 30, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. As announced on June 9, 2026, Corvus invested $5.0 million in a $13.5 million financing completed by Angel Pharma in the second quarter of 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028.

Research and development expenses for the three months ended June 30, 2026 totaled $16.0 million compared to $7.9 million for the same period in 2025. The increase in research and development expenses of $8.1 million was primarily due to higher clinical trial costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended June 30, 2026 was $18.0 million compared to $8.0 million for the same period in 2025. Included in net loss for the three months ended June 30, 2026 and 2025 were non-cash losses of $0.7 million and $0.4 million, respectively, from Corvus’ investment in Angel Pharma and a non-cash gain of $2.0 million in the second quarter of 2025 associated with a change in the fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended June 30, 2026 was $2.6 million compared to $1.3 million for the same period in 2025.

(Press release, Corvus Pharmaceuticals, AUG 6, 2026, View Source [SID1234669821])

On August 6, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment approach for ovarian cancer, reported financial results for the second quarter ended June 30, 2026, and highlighted recent corporate, regulatory and clinical progress and upcoming expected milestones.

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"We have achieved important milestones on the continued advancement of azenosertib in our registration-intended DENALI Phase 2 and ASPENOVA Phase 3 trials for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC), including completing the enrollment of DENALI Part 2b and aligning with the U.S. Food and Drug Administration (FDA) following a Type D meeting on our selected dose and DENALI study population to support potential accelerated approval," said Julie Eastland, Chief Executive Officer of Zentalis. "We remain as confident as ever that azenosertib has the potential to be an important oral, non-chemotherapy treatment option for the approximately 50% of PROC patients with Cyclin E1-positive tumors, who have limited options. We expect to provide the topline readout of DENALI Part 2 in 1H 2027. We continue to advance the confirmatory ASPENOVA Phase 3 trial with the goal of bringing a potential first-in-class WEE1 therapy to market for this underserved patient population globally. In addition to the lead indication, we see opportunity for expansion of azenosertib into platinum-sensitive settings of ovarian cancer and additional tumor types through combinations."

"We are well capitalized as of June 30, 2026 with cash, cash equivalents and marketable securities of $174.6 million to support the execution of key milestones and to continue advancing our regulatory strategy for both accelerated and full approval in PROC," Ms. Eastland continued.

Business Updates

•Regulatory Update: Met with the FDA in a Type D meeting regarding the Company’s accelerated approval strategy, including dose. The FDA had no objection to the continued study of the selected monotherapy dose of azenosertib at the 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) in patients with Cyclin E1-positive PROC, selected based on a pre-specified interim analysis from DENALI Part 2a. The FDA acknowledged the DENALI Part 2 study population, including the 2c cohort, has the potential to support an accelerated approval pathway, subject to the strength of the data and the landscape of approved agents at the time of regulatory action.
•DENALI Part 2 Enrollment and Integrated Topline Readout: Enrollment in DENALI Parts 2a and 2b is complete. Earlier this year, the Company expanded DENALI Part 2 to broaden the overall study population and enrich patients previously treated with a taxane-containing regimen for PROC, aligning the study population with the evolving treatment landscape of approved agents. DENALI Part 2c is currently enrolling. The integrated dataset of DENALI Parts 2a, 2b, and 2c is designed to support accelerated approval in the Cyclin E1 biomarker-selected patient population, subject to regulatory review. The Company expects to provide a topline readout in 1H 2027 to allow for data maturation post full enrollment.
•ASPENOVA Phase 3 First Patient Dosed: In May 2026, announced the first patient was dosed in the Phase 3 ASPENOVA confirmatory trial designed to satisfy FDA requirements for U.S. full approval and to support approval in major ex-U.S. markets. The trial is currently enrolling.
•ESMO 2026 Abstract Acceptances: Announced that the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) has accepted an abstract for rapid oral presentation at the 2026 ESMO (Free ESMO Whitepaper) Annual Meeting featuring overall survival analysis from Part 1b of the DENALI study of azenosertib in PROC patients. A second abstract featuring the ASPENOVA Phase 3 trial design has been accepted for a trial-in-progress poster presentation.
•MUIR Clinical Trial Data Presented at ASCO (Free ASCO Whitepaper) 2026: Presented results from Part 1 of the Phase 1b MUIR trial at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, focusing on an evaluation of azenosertib in combination with paclitaxel in PROC. The data showed combinability and activity of azenosertib in an all-comer PROC setting, demonstrating the potential for azenosertib in multiple lines of ovarian cancer and more broadly in combination with cytotoxic agents in other tumor types. Part 2 enrollment is ongoing for azenosertib in combination with bevacizumab for 2L platinum sensitive ovarian cancer.
•Expanded Commercial Capabilities: In May 2026, announced the appointments of Shannon Campbell to the Company’s Board of Directors and Sarah Kelly as SVP of Commercial Strategy to support commercialization readiness.

Second Quarter 2026 Financial Results
•Cash Position: Cash, cash equivalents and marketable securities were $174.6 million as of June 30, 2026, compared to $245.9 million as of December 31, 2025. The Company believes that its existing cash, cash equivalents and marketable securities as of June 30, 2026 will be sufficient to fund its operating expenses and capital expenditure requirements into late 2027.
•Research and Development Expenses: Research and development expenses for the three months ended June 30, 2026 were $35.2 million, compared to $27.6 million for the three months ended June 30, 2025. The increase of $7.6 million was primarily due to a $7.0 million milestone payment to Recurium IP Holdings, LLC required as a result of the commencement of the Phase 3 ASPENOVA clinical trial and an increase of $5.2 million related to clinical expenses and drug manufacturing, including costs associated with advancing the DENALI and ASPENOVA trials. This increase was partially offset by a decrease of $4.5 million for personnel expense, of which $2.1 million was non-cash stock-based compensation, and a decrease of $0.1 million related to allocated overhead.
•General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2026 were $9.2 million, compared to $8.4 million during the three months ended June 30, 2025. This increase of $0.8 million was primarily attributable to an increase of $1.7 million for consulting and outside services. This increase was partially offset by a decrease of $0.9 million for non-cash stock-based compensation.
•Total Operating Expenses: Total operating expenses were $44.4 million for the three months ended June 30, 2026, compared to $36.1 million for the three months ended June 30, 2025.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in 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.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive PROC. There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff.

Part 2, in total, is designed to support accelerated approval, pending positive study outcomes and further discussions with the FDA. The study design consists of the following parts:

•Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
•Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort has completed enrollment.
•Part 2c: Broadening study population, which is expected to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling. Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 (2a, 2b, 2c) and provide a topline readout by 1H 2027.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive PROC. The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). The trial design was based on feedback from the U.S. FDA regarding requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval.

About MUIR Clinical Trial
MUIR (NCT04516447) is a multi-part, open-label Phase 1b clinical trial evaluating the safety, efficacy, and preliminary clinical activity of azenosertib combinations in patients with ovarian cancer. Part 1 enrolled patients with platinum-resistant ovarian cancer (PROC) treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives are safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1.

Part 2 is evaluating azenosertib plus bevacizumab as maintenance regimen (first [1L] or second line [2L]) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose expansion portion will evaluate azenosertib at the recommended dose in combination with bevacizumab in patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion. The dose expansion portion is currently open for enrollment.

(Press release, Zentalis Pharmaceuticals, AUG 6, 2026, View Source [SID1234669808])