On May 11, 2026 Alpha Tau Medical presented its corporate presentation.

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(Presentation, Alpha Tau Medical, MAY 11, 2026, View Source [SID1234665427])

On May 11, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported financial results for the first quarter ended March 31, 2026, and provided an operational update on botensilimab plus balstilimab (BOT+BAL), the Company’s lead clinical program and one of the most clinically advanced next-generation CTLA-4/PD-1 combinations in development.

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The first quarter marked a transition from foundation-building to execution for BOT+BAL. Physician engagement through regulatory-authorized access pathways continued to broaden, the Phase 3 BATTMAN trial moved into active enrollment shortly after quarter-end, and the Zydus collaboration closed, delivering strategic capital and dedicated U.S. manufacturing capacity.

BOT+BAL is designed to activate both innate and adaptive immunity and extend immunotherapy benefit into tumors that have historically shown limited responsiveness to checkpoint inhibition.

"First quarter 2026 was a defining quarter for Agenus and for BOT and BAL," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "We saw continued physician requests and engagement treating patients with BOT and BAL through regulatory-authorized access pathways. Additionally, we advanced the program into Phase 3 enrollment and closed a transformative collaboration with Zydus that secured both capital and U.S. manufacturing capacity. BOT+BAL’s maturing data, particularly the durability of survival outcomes in refractory MSS colorectal cancer, continue to underpin our regulatory submissions in the United States and Europe."

Key Operational Highlights
Agenus is concentrating resources on BOT+BAL across three priorities: supporting physician-initiated access through regulatory-authorized pathways where permitted, advancing the Phase 3 BATTMAN trial, and building the clinical, manufacturing and operational readiness needed for the next stage of development.
Continued Physician Engagement Through Regulatory-Authorized Access Pathways
In parallel with clinical development, Agenus continues to support BOT+BAL access through regulatory-authorized pathways in certain countries. These programs are physician-initiated, patient-specific and governed by local regulations.
In France, BOT+BAL is available under the national Autorisation d’Accès Compassionnel framework for eligible patients, with reimbursed access across MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. Outside France, BOT+BAL may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local requirements and individual coverage decisions.
In Q1 2026, paid named-patient activity broadened to additional countries in South and Central America and Europe, reflecting continued physician interest and the unmet need for new options while regulatory review pathways advance.
In April 2026, Agenus named BAP Pharma as its global partner to support BOT+BAL access programs, including France’s AAC pathway and paid named-patient programs. BAP Pharma will support program requests, case coordination, regulatory navigation, distribution logistics and related payment processing, helping Agenus build a more consistent and scalable access infrastructure.
Medical Affairs Infrastructure Expanded to Support Increasing Physician Requests
Agenus also expanded Medical Affairs and early-access support capabilities to respond to increasing physician-initiated interest. These capabilities support scientific exchange, access request coordination, pharmacovigilance and structured collection of real-world safety and outcomes data where applicable.
Phase 3 BATTMAN Trial Active and Enrolling
The global Phase 3 BATTMAN trial commenced patient enrollment in April 2026 and is evaluating BOT+BAL versus best supportive care in patients with refractory, unresectable MSS/pMMR metastatic colorectal cancer, a setting where checkpoint inhibitors have historically shown limited benefit and treatment options remain limited.

BATTMAN is led by the Canadian Cancer Trials Group as an international cooperative-group trial, with participating academic networks in Canada, France, Australia and New Zealand. Site activation continues across participating regions. With BATTMAN underway, BOT+BAL is among the most clinically advanced next-generation CTLA-4/PD-1 immunotherapy programs in refractory colorectal cancer, supported by a global randomized Phase 3 study.

Zydus Collaboration Closed Strengthening Capital Position, Balance Sheet and Manufacturing Readiness
In January 2026, Agenus closed its previously announced strategic collaboration with Zydus Lifesciences, providing upfront capital and dedicated biologics manufacturing capacity to support clinical development, authorized access programs and potential future commercial supply of BOT+BAL. At closing, Zydus paid $91 million of upfront capital, subject to customary adjustments and escrow arrangements, and the $7.0 million Zydus Promissory Note was forgiven.

The collaboration delivered:

•
$75 million in cash consideration for the transfer of the Emeryville and Berkeley biologics manufacturing facilities
•
$16 million equity investment in Agenus common stock
•
Up to $50 million in contingent payments from Zydus tied to BOT and BAL production orders by Agenus
•
An exclusive license for Zydus to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories

The collaboration strengthens Agenus’ balance sheet while securing dedicated U.S. manufacturing infrastructure for the next stage of BOT+BAL clinical, regulatory and commercial expansion. It also supports Agenus’ ability to supplement existing supply for clinical development, authorized access pathways and potential future commercial readiness without requiring additional Agenus capital expenditures for dedicated manufacturing infrastructure.

Clinical Data Continue to Support Immune Activation and Durability Across Hard-to-Treat Tumors
Recent clinical and translational data presentations continue to add to the broader BOT+BAL evidence base, including evaluations of BOT+BAL in combination approaches across additional difficult-to-treat tumor types and in earlier stages of MSS mCRC treatment. These datasets support the Company’s view that BOT+BAL may contribute to durable, immune-mediated activity across tumors that have historically responded poorly to checkpoint inhibition.

Across Phase 1 and Phase 2 clinical trials, approximately 1,300 patients have been treated with botensilimab and/or balstilimab, with clinical activity observed across more than nine metastatic, late-line cancers settings. Agenus continues to view durability, survival and immune activation, rather than response rates alone, as meaningful measures of BOT+BAL’s clinical potential in cold or treatment-refractory tumors historically resistant to checkpoint inhibition.
First Quarter 2026 Financial Results
Cash and cash equivalents totaled $35.0 million as of March 31, 2026, compared with $3.0 million as of December 31, 2025. Subsequent to quarter-end, the Company received an additional $11.7 million in net proceeds from sales of common stock under its at-the-market equity offering program. The Company also expects to collect outstanding receivables under regulatory-authorized early access programs during the second quarter of 2026.

Pre-commercial product revenue of $4.6 million represents realized income from BOT+BAL provided to hospitals and treating physicians under regulatory-authorized early access pathways, including France’s AAC framework and paid named-patient programs in countries where permitted.

During the first quarter of 2026, Agenus made cash payments of approximately $51.8 million, principally to fund (i) the release of commercial-grade botensilimab supply through contract development and manufacturing organizations; (ii) the generation of clinical data sets through contract research organizations and clinical support providers in support of the Company’s planned accelerated approval submission in the United States and conditional marketing authorization application in the European Union; and (iii) settlement of obligations in connection with the closing of the Zydus collaboration, including finance lease and debt obligations, and other closing-related payments. These payments partly settled liabilities accrued in prior periods.

Agenus’ first quarter cash payments included substantial obligations associated with the Zydus closing and the build-out of clinical and pre-commercial supply. These are not representative of Agenus’ recurring operating expense profile. The Company continues to align its operating expense base with its previously communicated framework of approximately $50 million in annualized operating expenses to support BOT+BAL development priorities, and first quarter 2026 underlying operating performance was consistent with that framework.

In March 2026, Agenus triggered the first $20.0 million contingent payment from Zydus under the collaboration based on Zydus services provided which includes contracted work orders for BOT+BAL production activities. All contingent payments by Zydus are to fund services to be provided by Zydus to the Company.

Metric

Q1 2026

Q1 2025

Pre-commercial product revenue

$4.6 million

$0 million

Non-cash royalty revenue

$29.1 million

$23.6 million

Service and other revenue

$0 million

$0.5 million

Total revenue

$33.7 million

$24.1 million

Operating income (loss)

$15.1 million

$(13.3) million

Net income (loss)

$39.2 million

$(26.4) million

Cash, cash equivalents and short-term investments

$35.0 million

$18.5 million

2026 Strategic Priorities
•
Support responsible authorized access through France’s AAC framework and paid named-patient programs in select countries, with BAP Pharma serving as global access partner
•
Continue regulatory engagement, including planned accelerated approval and conditional marketing authorization pathways, supported by clinical data and real-world experience generated through authorized access pathways where applicable
•
Advance global BATTMAN trial enrollment in partnership with CCTG and participating academic networks
•
Maintain disciplined capital allocation and continue strengthening the balance sheet
•
Continue clinical and translational data generation across BOT+BAL programs
Resolution of SEC Investigation and Dismissal of Securities Class Action

On May 4, 2026, the U.S. Securities and Exchange Commission informed Agenus that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action. Separately, on March 24, 2026, the U.S. District Court for the District of Massachusetts granted Agenus’s motion to dismiss the related putative securities class action in its entirety. The lead plaintiff has filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit. Additional information regarding both matters is included in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.

(Press release, Agenus, MAY 11, 2026, View Source [SID1234665426])

On May 11, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers, reported key initiatives to advance and expand the potential of the elraglusib development program.

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Actuate is prioritizing the development of the elraglusib oral tablet formulation, which is intended to enhance patient convenience, broaden potential clinical utility, and improve the pharmacokinetic exposure of elraglusib across multiple oncology indications. This strategy is supported by an analysis of patient data from the recently completed Phase 2 study in metastatic pancreatic ductal adenocarcinoma (mPDAC), which identified a positive correlation between drug exposure and clinical outcomes, including meaningful improvement in overall survival.

To support this initiative, the Company recently received Investigational New Drug (IND) clearance from FDA to conduct a Phase 1/2 study designed to demonstrate that a higher overall exposure to elraglusib can be achieved with the oral formulation compared to the IV formulation. The study will evaluate the safety and potential efficacy of the oral formulation as a monotherapy in solid tumor patients, including those with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers, based on evidence of efficacy of the IV formulation in prior clinical studies and machine learning therapeutic target analyses.

The Company has worked with the European Medicines Agency (EMA) to obtain specific guidance regarding elements of a trial design for a potential single registration study for IV treatment of mPDAC. As demonstrated by the positive Phase 2 results published in Nature Medicine, elraglusib combined with gemcitabine plus nab-paclitaxel (GnP) showed statistically significant improvement in overall survival in patients that received the IV formulation of elraglusib once weekly. Going forward, the Company will work with the EMA and FDA on specific guidance regarding elements of the trial design for a potential single registration study with the oral tablet formulation of elraglusib.

"Advancing the elraglusib oral tablet is an important element to the success of our overall development strategy," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "Transitioning from an IV to an oral formulation of elraglusib, which better positions the program by improving patient convenience and broadening clinical and potential commercial utility, is supported by an analysis of the completed Phase 2 data of elraglusib in mPDAC, showing higher exposures are associated with improved clinical activity. With the IND for the oral program authorized, we are planning to advance into clinical development in the second half of 2026 with a clear focus on optimizing exposure, dose, and response."

Mr. Schmitt continued: "In parallel, we are actively exploring elraglusib’s combination potential in RAS-driven cancers, where early preclinical data show potential for synergy with RAS inhibitors. With a strong mechanistic rationale targeting key survival and resistance pathways, we believe an oral elraglusib has the potential to enhance the activity of RAS-targeted therapies and address adaptive resistance, positioning it as a potential backbone agent in combination regimens. We look forward to further maturing this data, with additional updates expected in mid-2026.

The planned Phase 1/2 study will initially evaluate oral elraglusib as a monotherapy in patients with advanced solid tumors. The study is intended to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), while also evaluating safety, pharmacokinetics (PK), and preliminary signals of antitumor activity. In the Phase 2 portion, the study will enroll patients with a higher likelihood of benefitting from elraglusib treatment, including those with melanoma, non-small cell lung cancer (NSCLC), colorectal, and/or pancreatic cancers."

Finally, the addition of new board member Martin Huber, MD, a highly experienced biotech leader with extensive experience in oncology drug development, further strengthens our strategic and execution capabilities. Dr. Huber is also currently a board member of Syndax Pharmaceuticals and, most recently, was the President and Chief Executive Officer of Mersana Therapeutics until its acquisition by Day One Pharmaceuticals in January 2026. His guidance will be instrumental as we advance the oral elraglusib program and execute on its next phase of growth. "I am excited to join a team that has successfully demonstrated improved survival in patients with pancreatic cancer who were treated with elraglusib," said Martin Huber, MD, Director, Actuate Therapeutics, Inc. "I look forward to helping the Actuate team advance the new oral formulation in the evolving pancreatic treatment landscape and potentially bring elraglusib to more patients."

(Press release, Actuate Therapeutics, MAY 11, 2026, View Source [SID1234665425])

On May 10, 2026 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted a third Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific fusion protein, IBI363, in combination with bevacizumab, for the treatment of patients with advanced microsatellite stable or proficient mismatch repair (MSS/pMMR) colorectal cancer (CRC) who have failed at least two prior lines of standard therapy. A Phase III clinical trial is about to initiate in China for this indication in the near term.

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Previously, IBI363 has received two BTDs from China’s NMPA CDE and two Fast Track Designations (FTDs) from the U.S. FDA, covering indications in non-small cell lung cancer and melanoma. The latest BTD further validates IBI363’s potential in addressing immunotherapy resistance and cold tumor challenges which represent a significant unmet medical need. The early-stage clinical data of IBI363 in advanced MSS/pMMR colorectal cancer were reported at 2025 ASCO (Free ASCO Whitepaper) conference (link), in which IBI363, in combination with bevacizumab, demonstrated promising efficacy in patients who have failed multiple prior lines of standard therapy.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "IBI363 is a promising next-generation IO agent by combining dual mechanisms—PD-1 blockade and IL-2-driven tumor-specific T-cell populations expansion—thus reshaping the tumor microenvironment. The new regulatory milestone underscores its clinical value in addressing unmet needs. We are accelerating IBI363’s global development across multiple tumor types together with our partner Takeda, to bring innovation therapies at the forefront of immunotherapy to benefit global patients."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly.

About MSS/pMMR Colorectal Cancer

Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR being the predominant subtype, accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed standard therapies, there remains a significant unmet medical need. Treatment options are limited, and prognosis remains poor.

About IBI363

IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

(Press release, Innovent Biologics, MAY 10, 2026, View Source [SID1234665406])

On May 8, 2026 Azalea Therapeutics, Inc., a biotechnology company redefining precision genomic medicines in vivo, reported that first-in-primate data from its proprietary in vivo CAR T cell platform have been accepted as a late-breaking abstract for oral presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting, taking place May 11 – 15, 2026 in Boston, Massachusetts.

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The late-breaking abstract, titled "A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration," describes the first in vivo generation of genomic site-specific engineered TRAC-CAR T cells in non-human primates. Azalea’s platform is designed to generate CAR T cells directly inside the body through a dual-vector approach that combines CD3-targeted enveloped delivery vehicles (EDVs) delivering transient Cas9 complexes with a T cell-tropic AAV (AAV-T) carrying a promoterless CAR gene flanked by TRAC homology arms. This approach enables precise insertion of the CAR gene at the TRAC locus, placing CAR expression under control of the endogenous T cell promoter.

In the study, six rhesus macaques received a single intravenous administration of EDV and AAV-T vectors at different dose levels without prior lymphodepletion. The study assessed in vivo TRAC-CAR T cell generation, TRAC-CAR-mediated B cell depletion in peripheral blood, lymph nodes and bone marrow, and safety parameters.

"These first-in-primate data represent a major milestone for Azalea and for the broader field of in vivo cell engineering," said Jenny Hamilton, Ph.D., co-founder, president and chief executive officer of Azalea Therapeutics. "In immune-competent non-human primates, a single intravenous administration of our dual-vector platform generated TRAC-CAR T cells in vivo and achieved complete target B cell depletion across peripheral blood, lymph nodes and bone marrow without lymphodepletion. We believe that achieving precise insertion at a defined genomic locus will be foundational to the safety, durability and physiologic regulation of future in vivo cell therapies. We believe these findings provide important translational support for our approach and the potential to make powerful cell therapies more accessible by eliminating the need for individualized ex vivo manufacturing."

First-in-Primate In Vivo TRAC-CAR T Cell Engineering

In the study, animals demonstrated in vivo generation of TRAC-CAR T cells, with TRAC-CAR T cells peaking as high as 41% of all peripheral T cells on Day 11. All six animals demonstrated deep B cell aplasia of greater than 90% in peripheral blood by Day 10.

The study also demonstrated potent target B cell clearance beyond peripheral blood. In lymph nodes and bone marrow, B cells were deeply depleted by greater than 90% in five of six animals at the highest dose level within two weeks following treatment.

Treatment was generally well tolerated, with no deaths, no neurotoxicity and a favorable safety profile. Molecular analyses confirmed no off-target CAR expression or integration in non-T cells in the blood.

"To our knowledge, this is the first demonstration of site-specific gene integration in T cells in a non-human primate in vivo. This study demonstrates that Azalea’s platform can achieve cell-selective delivery, genomic locus-specific CAR insertion and robust pharmacodynamic activity in a clinically relevant non-human primate model," said Connor Tsuchida, Ph.D., scientific co-founder, vice president of research and development at Azalea Therapeutics and presenting author of the abstract. "The combination of TRAC-targeted integration, endogenous promoter-driven CAR expression and activity across multiple tissue compartments supports continued advancement of this genome editing-based in vivo CAR T platform toward clinical translation."

Azalea will present these data at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting.

Abstract Title: A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration
Presenting Author: Connor A. Tsuchida, Ph.D., Azalea Therapeutics
Session: Oral Abstract Sessions – Late-breaking abstracts
Date/Time: Friday, May 15, 2026, 8:00 am – 9:45 am ET
Location: Westin Seaport Commonwealth Ballroom ABC (Concourse Level)

(Press release, Azalea Therapeutics, MAY 8, 2026, View Source [SID1234665405])