On May 12, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that its pivotal Phase 3 Bria-ABC study has screened over 315 and enrolled over 230 patients. BriaCell anticipates reporting topline data in 2026.

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!

BriaCell has received increased interest from leading cancer centers and continued enrollment momentum following the independent inclusion of its Phase 3 clinical trial in Nature Medicine’s article, "Eleven clinical trials that will shape medicine in 2026". The Phase 3 Bria-ABC study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, in combination with an immune checkpoint inhibitor versus physician’s choice of treatment in advanced breast cancer.

The interim analysis will be conducted after 144 patient events, defined as deaths, have occurred. Overall survival (OS) is the primary endpoint, and positive results could support full approval of Bria-IMT in patients with metastatic breast cancer. The Bria-IMT combination regimen has received FDA Fast Track designation.

"Sustained and new interest from world class institutions and their patients continues to drive remarkable patient engagement," stated Dr. William V. Williams, BriaCell’s President & CEO. "We remain on track to report the interim analysis in 2026 while continuing to enroll patients and advance preparations for potential commercialization, with the goal of bringing our novel immunotherapy regimen to patients with metastatic breast cancer as efficiently as possible."

For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612 .

(Press release, BriaCell Therapeutics, MAY 12, 2026, View Source [SID1234665585])

On May 12, 2026 Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), reported that the first presentation of clinical data from AJX-101, a Phase 1 clinical trial of AJ1-11095, a first-in-class type II JAK2 inhibitor, has been selected for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress taking place from June 11-14, 2026 in Stockholm, Sweden.

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!

"We’re excited to have this abstract of the first clinical results of AJ1-11095 selected for an oral presentation at the EHA (Free EHA Whitepaper) 2026 Congress," said David Steensma, MD, FACP, Chief Medical Officer of Ajax Therapeutics. "The encouraging safety and efficacy profile observed with AJ1-11095, including reductions in driver mutation VAF within a month of starting therapy, indicate that AJ1-11095 has the potential to address an unmet need for patients with myeloproliferative neoplasms."

The oral presentation will include results from the Phase 1 clinical trial, AJX-101, an open-label, multi-center study designed to evaluate the safety, tolerability and preliminary efficacy of AJ1-11095. The study has enrolled patients in the U.S. and Europe with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) who have been failed by a type I JAK2 Inhibitor. (NCT identifier: NCT06343805).

Details of the oral presentation session are as follows:

Presentation Title: Results of AJX-101, a Phase 1 Clinical Trial of the type II JAK2 Inhibitor AJ1-11095, in Patients with Myelofibrosis who have been Failed by a type I JAK2 Inhibitor

Presenter: John Mascarenhas, MD, Professor of Medicine, Icahn School of Medicine at Mt. Sinai and Director, Center of Excellence in Blood Cancers and Myeloid Disorders at Tisch Cancer Institute; principal investigator of the AJX-101 Phase 1 Study

Session title: s438 Myeloproliferative neoplasms – Clinical

Live session date & time: June 13, 2026 at 17:15–18:30 CEST

Session room: A2-3 Hall

Abstract number: S218

About AJ1-11095
AJ1-11095 was designed by Ajax Therapeutics using structure-based drug design and computational methods at scale to selectively bind the type II conformation of the JAK2 kinase in order to provide greater efficacy with disease modification compared to all currently approved JAK2 inhibitors, including ruxolitinib, which bind the type I conformation of JAK2.

About Myelofibrosis
Myelofibrosis (MF) is a rare blood cancer that affects approximately 20,000 patients in the United States and approximately 26,000 patients in Europe. The disease is characterized by spleen enlargement, scarring (fibrosis) in the bone marrow, progressive anemia, and debilitating symptoms such as fatigue, night sweats, itching, and abdominal discomfort, which can impair a patient’s quality of life. The most widely used treatment for MF patients are type I JAK2 inhibitors, which can reduce spleen size and provide symptomatic improvement but have little effect on the underlying cause of disease. Over time, most MF patients stop type I JAK2 inhibitor therapy; the most common causes for treatment discontinuation include a lack of benefit or loss of response, adverse events such as anemia, and disease progression.

(Press release, Ajax Therapeutics, MAY 12, 2026, View Source [SID1234665584])

On May 12, 2026 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported financial results for the first quarter ended March 31, 2026, and provided an update on recent corporate developments.

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!

"Based on extensive analysis of data across the two global Phase 3 studies of setrusumab in osteogenesis imperfecta in collaboration with our partner Ultragenyx, we believe there is basis to engage with the regulatory agencies to determine if there is a path forward in pediatric patients. These interactions have been initiated, and we plan to provide updates once we have some definitive feedback. We continue to believe that setrusumab has the potential to provide meaningful benefit for people living with OI, a condition with no FDA or EMA approved therapies," said Denise Scots-Knight, Chief Executive Officer of Mereo. "We are engaged with potential partners for alvelestat in AATD-LD and believe alvelestat can quickly enter Phase 3 development following closing of a partnership transaction. Our other partnered program, vantictumab, is continuing to move forward with āshibio, who plan to initiate a Phase 2 trial in osteopetrosis in the second half of 2026. We continue to expect that our cash position, which totaled $36.2 million as of March 31, will provide runway into mid-2027, through several key inflection points expected during the remainder of this year."

Recent Corporate Developments and Anticipated Milestones

Setrusumab (UX143)

Further analyses of the data from the Orbit and Cosmic Phase 3 studies, including patient subgroups, have been completed.
While neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic), both studies achieved high statistical significance against the key secondary endpoint of improvement in bone mineral density versus control as well as reductions in vertebral fractures and improvements in patient reported outcomes (PROs) associated with disease severity, pain / discomfort and daily activities, with these PRO improvements achieving statistical significance in the Orbit study.
The safety profile of setrusumab was consistent with that observed in prior studies.
Based on the Phase 3 data analysis from both global Phase 3 studies and the safety profile of setrusumab, Mereo and its partner Ultragenyx believe there is a basis to engage regulatory agencies to determine if there is a path forward for setrusumab in pediatric patients. These interactions have been initiated.
Alvelestat (MPH-966)

Mereo is actively engaged in discussions with potential partners for the Phase 3 development and commercialization of alvelestat.
Based on previous discussions with the FDA and EMA, Mereo anticipates a single Phase 3 trial enrolling approximately 220 early- and late-stage AATD-LD patients evaluating alvelestat over an 18-month treatment period will support regulatory submissions in both the U.S. and Europe.
The primary efficacy endpoint for potential U.S. approval will be the St. George’s Respiratory Questionnaire (SGRQ) Total Score, with lung density measured by CT scan serving as the primary endpoint for potential European regulatory approval. These are independent primary endpoints.
The Company believes initiation of the Phase 3 study could happen within 6 months of closing a potential partnership transaction.
Vantictumab (OMP18R5)

The Company’s development partner for vantictumab, āshibio, Inc., is continuing to advance toward initiation of a Phase 2 clinical trial in autosomal dominant osteopetrosis Type 2 (ADO2), which is expected to commence in the second half of 2026.
āshibio is responsible for funding the global clinical program and holds the right to commercialize vantictumab outside of Europe, where Mereo has retained commercial rights.
First Quarter 2026 Financial Results

Total research and development ("R&D") expenses increased by $0.8 million, from $3.9 million in the first quarter of 2025 to $4.7 million in the first quarter of 2026. The increase was primarily due to increases of $1.8 million in R&D expenses for setrusumab, partially offset by reductions of $0.9 million in R&D expenses for alvelestat. The increase in program expenses for setrusumab was primarily driven by recognition of a payable for our share of certain costs related to the cancellation of manufacturing slots by our partner, Ultragenyx, partially offset by reductions of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the first quarter of 2026. The decrease in program expenses for alvelestat was primarily due to completion of activities undertaken in preparation for the potential Phase 3 study in the first quarter of 2025.

General and administrative expenses decreased by $3.3 million, from $7.3 million in the first quarter of 2025 to $4.0 million in the first quarter of 2026. The decrease was primarily due to the recognition of a $1.9 million reduction in expenses in the first quarter of 2026 for amounts received from our depository to reimburse certain expenses incurred by us in respect of our ADR program, and a reduction of approximately $1.4 million driven by delays to investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, if approved, and other realized cost savings.

Net loss for the first quarter of 2026 was $6.7 million, compared to $12.9 million for the first quarter of 2025, primarily reflecting an operating loss of $8.8 million and foreign currency transaction gain of $1.6 million.

As of March 31, 2026, the Company had cash and cash equivalents of $36.2 million, compared to $41.0 million as of December 31, 2025. The Company’s guidance remains unchanged, and it continues to expect, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses, and capital expenditure requirements into mid-2027. This guidance does not include any potential payments associated with business development activity around any of the Company’s programs.

Total ordinary shares issued as of March 31, 2026 were 798,078,829. Total ADS equivalents as of March 31, 2026 were 159,615,765, with each ADS representing five ordinary shares of the Company.

(Press release, Mereo BioPharma, MAY 12, 2026, View Source [SID1234665583])

On May 12, 2026 MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune disorders, reported data being presented at the American Society of Gene and Cell Therapy Annual Meeting (ASGCT 2026) in Boston, Massachusetts. The data demonstrate that agenT-797, MiNK’s off-the-shelf, allogeneic iNKT cell therapy produces fundamentally different, disease-appropriate immune responses in patients with solid tumors and patients with acute respiratory distress syndrome (ARDS), driven by the intrinsic biology of iNKT cells rather than genetic modification.

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!

The data, to be presented in Poster 3371 on May 14, 2026, by Dr. Yan demonstrates that the same agenT-797 product, manufactured from the same donor batch and administered without modification, drove a TH1 pro-inflammatory immune program in 34 patients with solid tumors and a TH2 anti-inflammatory immune response in 20 patients with ARDS. The findings were consistent across multiple manufacturing batches and donors, establishing platform reproducibility at scale.

"The same off-the-shelf cell — from the same donor, same manufacturing batch — drives inflammation in a tumor and restores immune homeostasis in a failing lung. Without modification. Without engineering. That is intrinsic iNKT biology, and it is the foundation of a scalable platform we believe is applicable across oncology, critical illness, and beyond. To our knowledge, no prior cellular therapy platform has demonstrated this type of disease-directed immune response across two fundamentally different diseases from a single manufacturing run," said, Jennifer Buell, Ph.D., President and Chief Executive Officer, MiNK Therapeutics.

These findings further support the scalability and consistency of MiNK’s proprietary manufacturing platform, which is designed to isolate donor-derived iNKT cells and reproducibly expand them to billions of cells per donor while preserving intrinsic biological activity across disease settings. agenT-797 is cryopreserved, HLA-independent, and requires no lymphodepletion, supporting potential use across acute critical care, oncology, and post-transplant immune dysfunction.

ASGCT Poster 3371: Context-Dependent Immune Reprogramming in Cancer and ARDS

Clinical evidence of effector function: agenT-797 was associated with tumor clearance and durable response in patients with cancer, including complete resolution of metastatic disease in germ cell testicular cancer treated with agenT-797 plus anti-PD-1 (Garmezy et al., Oncogene, 2025). In ARDS, agenT-797 was associated with improved survival and radiographic resolution of ARDS relative to in-hospital controls, including clearance of carbapenem-resistant Pseudomonas pneumonia in a 21-year-old patient on veno-venous ECMO.
In 34 solid tumor patients (NCT05108623), agenT-797 infusion produced rapid IFN-gamma elevation — a TH1 pro-inflammatory signature consistent with anti-tumor immune activation.
In 20 ARDS patients (NCT04582201), the same product from the same manufacturing donor batch produced IL-4 and IL-13 elevation — a TH2 anti-inflammatory signature consistent with immune restoration and lung injury recovery.
Favorable safety profile: Immune activation across both oncology and ARDS settings occurred without evidence of uncontrolled cytokine release syndrome or pathologic hyperinflammation, supporting a favorable therapeutic index appropriate for the ICU setting.

"What makes these findings compelling is that we are observing the same unmodified iNKT cell product generate fundamentally different immune responses across distinct disease states in a biologically coherent and clinically relevant manner," said Terese C. Hammond, MD, Head of Inflammatory and Pulmonary Diseases, MiNK Therapeutics. "These findings support the idea that iNKT cells function as coordinated immune effectors capable of dynamically modulating inflammatory and restorative pathways based on the disease environment. In critical illness, effective therapy may require coordinated immune activation, restoration, and pathogen-directed response occurring simultaneously. The Phase 1/2 clinical data suggested this biology was possible; the ASGCT (Free ASGCT Whitepaper) findings now provide mechanistic evidence supporting how agenT-797 may achieve those effects."

(Press release, MiNK Therapeutics, MAY 12, 2026, View Source [SID1234665582])

On May 12, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported two abstracts have been accepted for oral presentations at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, which will be held June 11-14, 2026, in Stockholm, Sweden.

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!

The first oral presentation will highlight the long-term durability of a single dose of vispa-cel in patients enrolled in the ANTLER phase 1 clinical trial for relapsed or refractory B cell non-Hodgkin lymphoma. Details of the ANTLER phase 1 presentation are as follows:

Title: Vispa-cel, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, in patients with relapsed/refractory B cell non-Hodgkin lymphoma (ANTLER phase 1 clinical trial)
Presenter: Stephen J. Schuster, MD, Robert and Margarita Louis-Dreyfus professor of chronic lymphocytic leukemia and lymphoma; department of medicine, hematology-oncology division;
director, lymphoma program and lymphoma translational research; Abramson Cancer Center, University of Pennsylvania
Date and time: Friday, June 12, 2026, at 5:15 – 6:30pm CEST
Session: Prospective lymphoma trials
Location: Nobel Hall
Abstract number: S236

The second oral presentation includes longer follow-up from patients enrolled in the dose escalation portion of the ongoing CaMMouflage phase 1 clinical trial evaluating CB-011 in patients with relapsed or refractory multiple myeloma. Details of the CaMMouflage phase 1 presentation are as follows:

Title: CB-011, an allogeneic anti-BCMA CAR-T cell therapy with immune cloaking, for patients with relapsed/refractory multiple myeloma (CaMMouflage phase 1 trial)
Presenter: Binod Dhakal, MD, associate professor of medicine, Medical College of Wisconsin
Date and time: Sunday, June 14, 2026, at 11:00am – 12:15pm CEST
Session: Immunotherapy in multiple myeloma
Location: Victoria Hall
Abstract number: S201

Accepted abstracts are now available on the EHA (Free EHA Whitepaper) Annual Meeting website.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. As of a September 2, 2025, data cutoff date, 84 patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40×106, 80×106, or 120×106 CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Eighty million (80×106) CAR-T cells was selected as the recommended phase 2 dose (RP2D). Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Five patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days. The dose expansion portion of the trial is evaluating safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, MAY 12, 2026, View Source [SID1234665581])