On August 11, 2025 Agenus Inc. ("Agenus" or the "Company") (Nasdaq: AGEN), an immuno-oncology company focused on innovation, reported financial results for the second quarter of 2025 and highlighted major clinical, regulatory, and operational milestones supporting the advancement of its botensilimab (BOT) and balstilimab (BAL) immunotherapy combination (Press release, Agenus, AUG 11, 2025, View Source [SID1234655062]). Botensilimab is a next-generation, multifunctional, Fc enhanced, CTLA-4 antibody and BAL is a proprietary PD-1 antibody; together they are designed to trigger robust and durable immune attacks against "cold," treatment-resistant tumors, offering new hope where standard therapies have failed.

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"Our team is committed to advancing BOT/BAL to deliver meaningful benefits to patients with treatment-resistant cancers, and we are working with regulatory agencies to expedite access through a streamlined Phase 3 trial," said Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "With significant clinical progress, strategic partnerships, and prudent financial management, we are well-positioned to execute our vision of transforming cancer care."

Regulatory Highlights

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Breakthrough Survival in Refractory MSS CRC – At the 2025 ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress, BOT + BAL reported a 42% two-year survival rate and median overall survival of ~21 months in a trial of 123 patients with refractory no liver met MSS metastatic colorectal cancer (mCRC).
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Regulatory Alignment on Registrational Phase 3 Trial (BATTMAN) – Following an End-of-Phase 2 meeting on July 1, 2025, the FDA agreed to a streamlined two-arm BATTMAN Phase 3 design, having agreed to BOT/BAL’s contribution of components. This agreement also marks a shift from a three-arm trial previously proposed by regulators and enables trial initiation in Q4 2025.
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Expanding Evidence Across Tumor Types – New data from a neoadjuvant pan-cancer trial (NEOASIS study) showed robust pathological responses across MSS and MSI-H solid tumors, including triple-negative breast cancer, with no dose-limiting toxicities. Translational data from ASCO (Free ASCO Whitepaper) confirmed BOT/BAL’s ability to activate T cells and address resistance in MSS tumors, supporting its potential across cancers.

Exhibit 99.1

"The BOT/BAL combination is delivering durable responses and survival outcomes in refractory MSS colorectal cancer," said Richard M. Goldberg, M.D., Chief Development Officer of Agenus. "With regulatory clarity and a focused development team, we are poised to execute the BATTMAN trial and explore earlier treatment settings to maximize patient impact."

Strategic Partnerships

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Zydus Lifesciences Collaboration – The collaboration for U.S. manufacturing and commercialization in India/Sri Lanka is progressing toward a Q3 2025 closing, delivering $91M in upfront capital and equity investment upon closing to support development and regulatory activities.
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Noetik AI Biomarker Collaboration using AI algorithms – Agenus commenced a partnership with Noetik AI to refine patient selection, enhancing BOT/BAL’s clinical impact and unlocking potential future revenue streams through precision oncology.
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Broader Portfolio Synergies – Agenus continues to leverage its significant ownership of MiNK Therapeutics and SaponiQx, to advance combination treatments with adoptive cell therapies and adjuvants, broadening its immuno-oncology pipeline.
Key 2H 2025 Catalysts—Building on recent clinical, regulatory, and partnership momentum, Agenus anticipates several significant milestones in the second half of 2025:

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Registrational Trial Launch – In Q4 2025, initiate the global BATTMAN Phase 3 trial of BOT/BAL in refractory MSS CRC in partnership with the Canadian Clinical Trials Group (CCTG), committed to executing with speed and precision.
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Significant Clinical Data Generation – Expand evidence for BOT/BAL’s activity in earlier-line and neoadjuvant MSS colorectal cancer and other tumors through strategic collaborations and investigator-sponsored trials.
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Upcoming Data Presentations – Share new BOT/BAL clinical results in colorectal and other solid tumors at major oncology congresses in Q4 2025, reinforcing its therapeutic potential.
Financial Highlights—Agenus continues to strengthen its financial position through prudent cost management and strategic capital-raising efforts in addition to Zydus collaboration, positioning the company to execute its clinical and regulatory objectives. Key financial metrics for Q2 2025 are summarized below:

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Revenue and Net Loss – Agenus reported revenue of $25.7 million for Q2 2025 and $49.8 million for Q2 YTD 2025, primarily from non-cash royalty revenue, compared to $51.5 million in Q2 YTD 2024. The net loss Q2 YTD 2025 was $56.4 million, or $2.03 per share, a significant improvement from $118.3 million, or $5.56 per share, for Q2 YTD 2024.
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Reduced Cash Burn – Cash used in operations decreased to $45.8 million for Q2 YTD 2025 from $76.4 million for Q2 YTD 2024. These reductions are a consequence of prudent cost management and are expected to continue into the second half of 2025. Agenus is also in active negotiations for collaborations that could result in additional significant infusions of cash resources.
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Liquidity and Future Outlook – With the $91 million Zydus infusion expected upon closing, combined with its current cash balance, Agenus expects to fund the launch of its Phase 3 trial. Further, the company is in negotiations to secure additional funding streams from partnerships currently under negotiation and BOT/BAL’s commercial prospects in geographies beyond North America, Europe and Japan.
Webcast and Conference Call Information

The Company will host a webcast and Stakeholder Briefing on August 27, 2025, to review Q2 financial results, anticipated data milestones, and the global BOT/BAL development program.

On August 11, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that it has received feedback from the US Food and Drug Administration (FDA) regarding the next stages of clinical development for amsulostat in myelofibrosis (MF) (Press release, Syntara, AUG 11, 2025, View Source [SID1234655047]).

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During a Type C meeting, the FDA reviewed a comprehensive data package that included interim data (as presented at the European Hematology Association (EHA) (Free EHA Whitepaper) congress in June 2025) from the ongoing open label trial (MF-101) of amsulostat in combination with ruxolitinib, as well as a proposal for a pivotal registrational study.

The FDA has provided guidance that a Phase 2 trial with a control arm be undertaken to acquire additional safety and efficacy data, focussing on improvements in symptoms and spleen volume reductions in order to optimise the design and efficiency of a subsequent pivotal Phase 3 trial.

Syntara CEO Gary Phillips said: "Over the coming period we will use the FDA guidance to refine our clinical development plan for amsulostat and continue discussions with partners based on the FDA recommended path forward. Syntara is in a strong position given the depth and quality of our pipeline and a cash runway that will take us into 2027. We look forward to sharing results from our ongoing clinical trials over the coming months."

Syntara’s updated clinical pipeline development plan is shown in the following table:

Investor Webinar

Syntara will hold an investor webinar following today’s announcement regarding the next stages of clinical development for amsulostat.

CEO Gary Phillips will provide an update and presentation as part of the webinar, to be held at 12 noon AEST Monday 11 August 2025.

Shareholders, investors and interested parties are encouraged to register to attend the presentation at the following link:

View Source

After registering, you will receive a confirmation email containing information about joining the webinar as well as dial-in details for those that wish to join by phone.

On August 10, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been dosed in its multicenter, randomized, double-blind Phase III study (AK112-311/HARMONi-9), evaluating ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by Akeso, in small cell lung cancer (SCLC) (Press release, Akeso Biopharma, AUG 10, 2025, View Source [SID1234655048]). This study is designed to assess the efficacy and safety of ivonescimab as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced progression following standard concurrent chemoradiotherapy (cCRT).

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AK112-311/HARMONi-9 study is the eighth registrational Phase III clinical trial for ivonescimab in lung cancer (including three international multicenter studies). The initiation of this trial further expands ivonescimab’s therapeutic coverage across key lung cancer indications and different lines of treatment. As the world’s first PD-1/VEGF bispecific antibody, ivonescimab is driving significant transformation in the overall lung cancer treatment landscape and holds the potential to fundamentally improve global lung cancer therapies.

Small cell lung cancer (SCLC) represents approximately 15% of all lung cancers and is known for its aggressive nature, early metastasis, and poor prognosis. Around 30% of patients are diagnosed at the limited stage (LS-SCLC), with over 80% being ineligible for surgical intervention. The current standard of care involves concurrent or sequential chemoradiotherapy (cCRT/sCRT), where most patients face recurrence or develop drug resistance. To date, only one PD-L1 therapy has been approved for consolidation treatment for LS-SCLC, highlighting the significant unmet clinical need of this difficult to treat cancer.

In previous studies focused on extensive-stage SCLC (ES-SCLC), ivonescimab has demonstrated its ability to prolong progression-free survival (PFS), combining the synergistic benefits of PD-1/L1 inhibitors and anti-angiogenic agents. Ivonescimab is a cornerstone in Akeso’s "IO 2.0" strategy, and Akeso has already initiated a series of Phase III and Phase II clinical trials investigating ivonescimab as a first-line treatment across multiple cancer indications. The initiation of a Phase III study of ivonescimab for LS-SCLC is another key step in extending Akeso’s "IO 2.0" approach to earlier stages of lung cancer.

On August 8, 2025 Oncolys BioPharma reported Non-consolidated Financial Results for the Six Months Ended June 30, 2025.

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(Press release, Oncolys BioPharma, AUG 8, 2025, View Source [SID1234661741])

On August 8, 2025 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the supplemental new drug application ("sNDA") for toripalimab (trade name: TUOYI) in combination with disitamab vedotin, an antibody-drug conjugate ("ADC") developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is defined as a HER2 immunohistochemistry test result of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma ("UC") has been accepted by the National Medical Products Administration ("NMPA") (Press release, Shanghai Junshi Bioscience, AUG 8, 2025, View Source [SID1234656128]). This is toripalimab’s 13th application for marketing submitted in the Chinese mainland.

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UC is one of the ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising annually. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths reached over 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.

In 2021, toripalimab was approved for the second-line and above treatment of advanced UC, becoming the first immunotherapy drug approved for non-selective, population-based indications of advanced UC in China. Over the past 5 years, the emergence of PD-(L)1 monoclonal antibodies and novel ADCs has been continuously reshaping the treatment landscape for advanced UC. Compared with conventional chemotherapy, novel therapies have demonstrated significant improvements in terms of survival benefit and tolerability, leading to more diverse and precise treatment options for patients.

The sNDA is based on results from the RC48-C016 study (NCT05302284), a multi-center, randomized, open-label and controlled phase 3 clinical trial, which evaluated the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2 (human epidermal growth factor receptor 2)-expressing locally advanced or metastatic UC. The study was conducted in 74 clinical centers across China with Professor Jun GUO from Beijing Cancer Hospital and Professor Aiping ZHOU from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigators.