On August 13, 2025 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Kezar Life Sciences, AUG 13, 2025, View Source [SID1234655198]).

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"We are on track with our clinical development and regulatory submission plan for zetomipzomib in autoimmune hepatitis," said Chris Kirk, PhD, CEO and co-founder of Kezar. "We are committed to working closely with the FDA to align on our next trial design, which we have proposed as a registration-enabling study. The Type C meeting will be an important milestone as we continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with autoimmune hepatitis."

Zetomipzomib: Selective Immunoproteasome Inhibitor
•In March, Kezar reported topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib in patients with autoimmune hepatitis (AIH). In relapsed or refractory AIH patients who entered screening on steroid-based therapy, 36% (5 of 14) of zetomipzomib-treated patients achieved a complete biochemical response (CR) and clinically significant steroid taper to 5 mg/day or less by 6 months, compared to 0 of 7 placebo patients. The median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension at the time of the data cutoff), and no disease flares were reported in any zetomipzomib-treated patient achieving CR during study. A favorable safety profile was observed during the 6-month blinded treatment period.

•In July, Kezar announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with AIH.
•Kezar submitted a Type C meeting request to the FDA to meet during the fourth quarter of 2025 to discuss the AIH development plan for zetomipzomib.

•Kezar submitted a complete response to the FDA Division of Rheumatology and Transplant Medicine with a request to remove the clinical hold on zetomipzomib in lupus nephritis.
Medical Conferences
•An abstract featuring PORTOLA Phase 2a data has been selected for an oral presentation at The Liver Meeting 2025, taking place November 7-11, in Washington, DC.
•An abstract featuring PORTOLA biomarker data has been selected for poster presentation at The Liver Meeting 2025.
Business Updates
•In June, Zung To was promoted to Chief Development Officer. Mr. To joined Kezar in 2023 as Senior Vice President & Head of Clinical Development and brings 35 years of industry experience, with more than 20 years in senior leadership roles in early-and late-stage clinical development. He has been instrumental in leading Kezar’s development strategy and has played a pivotal role in progressing the Company’s clinical trials with speed and precision.

Financial Results
•Cash, cash equivalents and marketable securities totaled $100.8 million as of June 30, 2025, compared to $132.2 million as of December 31, 2024. The decrease was primarily attributable to cash used in operations.
•Research and development (R&D) expenses for the second quarter of 2025 decreased by $6.7 million to $9.6 million, compared to $16.3 million in the second quarter of 2024. This decrease was primarily due to the decreased clinical activities resulting from the completion and closeout of clinical trials, a decrease in personnel costs including non-cash stock-based compensation and a decrease in facility related expenses.
•General and administrative (G&A) expenses for the second quarter of 2025 decreased by $0.6 million to $5.0 million compared to $5.6 million in the second quarter of 2024. The decrease was primarily due to a decrease in non-cash stock-based compensation and personnel-related expenses.
•Restructuring and impairment charges for the second quarter of 2025 decreased by $1.5 million, compared to the second quarter of 2024. The decrease was primarily attributed to the impairment charge in 2024 related to the right-of-use asset for the vacated floor in the company’s leased office facility.
•Net loss for the second quarter of 2025 was $13.7 million, or $1.87 per basic and diluted common share, compared to a net loss of $21.5 million, or $2.96 per basic and diluted common share, for the second quarter of 2024.
•Total shares of common stock outstanding were 7.3 million shares as of June 30, 2025.

On August 13, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the creation of its Oncology Scientific Advisory Board (SAB) (Press release, Zai Laboratory, AUG 13, 2025, View Source [SID1234655220]). The newly formed Oncology SAB is comprised of distinguished oncology leaders and will support the advancement of the Company’s robust oncology products and pipeline, including multiple internally developed investigational therapies.

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"We are honored to bring together this esteemed group of oncology leaders who will support our continued development and advancement of innovative treatment options for patients globally," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "The formation of this Board is an important step for Zai; we know our clinical programs will benefit tremendously from the guidance and perspective of this highly regarded and experienced group of individuals."

Zai Lab’s Oncology SAB comprises the following:

Lieping Chen, M.D., Ph.D., is a United Technologies Corporation chair in cancer research, professor of immunobiology, dermatology and medicine at the Yale University School of Medicine.

Richard S. Finn, M.D., is director of the Signal Transduction Program in the Jonsson Comprehensive Cancer Center at University of California, Los Angeles (UCLA).

Thomas F. Gajewski, M.D., Ph.D., directs the Melanoma Oncology Clinic and leads the Immunology and Cancer Program at the University of Chicago Comprehensive Cancer Center.

Melissa L. Johnson, M.D., directs lung cancer research at the Sarah Cannon Research Institute.

Matthew Krebs, M.D., Ph.D., is a clinical senior lecturer in experimental cancer medicine at the University of Manchester and leads early phase clinical trials at The Christie NHS Foundation Trust, Manchester, U.K.

Patricia LoRusso, M.D., D.O., is director of the Early Phase Clinical Trials Program and Associate Center Director of Experimental Therapeutics at Yale Cancer Center.

Michael T. Lotze, M.D., FACS, is professor of surgery, immunology and bioengineering, and director of the DAMP Laboratories at the University of Pittsburgh Medical Center Hillman Cancer Center.

Timothy Yap, M.B.B.S., Ph.D., FRCP, is a medical oncologist, physician-scientist and professor at the University of Texas MD Anderson Cancer Center.

On August 13, 2025, the Strategic Collaboration and License Agreement between Adaptive Biotechnologies Corporation ("Adaptive") and Genentech, Inc. ("Genentech"), dated as of December 19, 2018 (the "Agreement"), was terminated, with termination effective February 9, 2026 (Filing, 8-K, Adaptive Biotechnologies, AUG 13, 2025, View Source [SID1234655339]). Adaptive and Genentech entered into the Agreement in 2018 to collaborate on research and development of certain cancer cell therapy products.

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The parties will wind down activities under the Agreement. Upon termination, Adaptive will be released from exclusivity obligations with respect to cell therapies in oncology.

As a result of the termination, Adaptive expects to recognize $33.7 million during the second half of 2025 in non-cash revenue from the remaining amortization of the cash consideration received under the Agreement.

Adaptive’s ongoing Immune Medicine programs and financial goals continue to focus on: (i) developing and deploying digital TCR-antigen prediction models that enable novel immunology applications and partnering opportunities; (ii) developing a pre-clinical data package for the lead T-cell depletion program in autoimmunity; and (iii) achieving the fiscal year 2025 Immune Medicine cash burn target of $25–$30 million.

On August 13, 2025 Evotec reported half-year interim report for the year 2025 (Filing, 3 mnth, JUN 30, Evotec, 2025, AUG 13, 2025, View Source [SID1234655617]).

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On August 13, 2025 CuraCell reported that the Paul-Ehrlich-Institut (PEI), the German federal authority for vaccines and biomedicines, has approved the company’s Clinical Trial Application (CTA) to initiate a Phase I/IIa clinical trial evaluating its novel autologous TIL (Tumor-Infiltrating Lymphocyte) therapy, CC-38, in patients with metastatic colorectal cancer and metastatic prostate cancer. The clinical trial is planned to commence in the second half of 2025.

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The open-label Phase I/IIa trial will enroll up to 16 patients with advanced solid tumors, including colorectal and prostate cancer (EU-CT-Number: 2025-521227-70-00). The study will be conducted at Krankenhaus Nordwest in Frankfurt. The trial will assess the feasibility of repeated administration, with safety and tolerability as the primary endpoints. Secondary objectives include evaluating preliminary anti-tumor activity and immune responses.

"This CTA approval marks a major milestone for CuraCell and affirms the strength of our science and clinical strategy," said Jonas Båtelson, CEO of CuraCell. "Our dedicated team, together with our expert collaborators, has worked tirelessly to advance our first TIL therapy from bench to bedside. This is a big step forward in our mission to provide curative treatments for the toughest and most deadly solid tumors."

(Press release, CuraCell, AUG 13, 2025, View Source [SID1234661187])