On May 13, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the first quarter of 2026, highlighting commercial momentum for ZEVASKYN.

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Steady increase in ZEVASKYN adoption with three patients completing treatment in the first quarter of 2026, one treatment to date in the second quarter, one biopsy currently in manufacturing process, and six additional patients expected to be biopsied in the second quarter, three of whom have biopsies scheduled.
Qualified treatment center (QTC) network expands to six sites with the activation of New York-Presbyterian / Columbia University Irving Medical Center in New York, NY and Children’s Hospital of Philadelphia (CHOP).
Patient access to ZEVASKYN continues to grow with published coverage policies now in place for 95% of commercially insured U.S. lives.
Data presentation at SID2026 on sustained wound healing and long-term safety after one-time pz-cel application: 12-year case report and 5-year Phase 3 data
"We are excited that an increasing number of patients at our QTCs are getting scheduled for ZEVASKYN slots this quarter," said Vish Seshadri, PhD, President and CEO of Abeona Therapeutics. "We’re encouraged by the recent acceleration of onboarding efforts of QTCs to activate, so they can begin to treat patients with ZEVASKYN."

Pipeline Update

Building on its proven end-to-end competency in engineered cell therapy, Abeona will focus its development efforts on ABO-701, a recently licensed radically novel engineered T-cell therapy targeting Prostate-Specific Membrane Antigen (PSMA). PSMA is a validated target for advanced prostate cancer, which is a leading cause of cancer mortality, with more than 30,000 deaths annually in the U.S. despite multiple approved therapies and recent advances in the field.

ABO-701 is an autologous engineered T-cell therapy that carries a Synthetic Immune Receptor (SIR-T) designed to overcome the limitations of CAR and TCR approaches. The SIR-T platform underlying ABO-701 was developed by Preet M. Chaudhary, M.D., Ph.D., Professor of Medicine and Chief of Jane Ann Nohl Division of Hematology and Center for the Study of Blood Diseases at University of Southern California (USC) Keck School of Medicine and Director of USC Blood and Marrow Transplant and Cell Therapy Program. The patents covering the SIR-T platform are owned by Angeles Therapeutics, Inc. In pre-clinical studies, ABO-701 has demonstrated durable tumor control in mouse models and modest levels of cytokine release – a profile that has been elusive to other engineered cell therapies in the solid tumors.

Abeona expects to file an Investigational New Drug (IND) application and commence first-in-human studies with ABO-701 in the second half of 2027 while engaging a contract development and manufacturing organization for supply readiness in the meantime. This development plan and timing allow the Company to maintain its focus on commercializing ZEVASKYN.

As part of the Company’s portfolio optimization, Abeona has deprioritized its in-house ophthalmology programs.

First Quarter 2026 Financial Results

Abeona reported net product revenue of $8.7 million in the first quarter ending March 31, 2026. This represents a quarter-over-quarter increase in net product revenue of $6.3 million compared to $2.4 million in the fourth quarter of 2025.

Cost of sales for the first quarter of 2026 was $2.7 million, primarily driven by scaling of commercial ZEVASKYN. This represents a quarter-over-quarter increase in cost of sales of $1.7 million compared to $1.0 million in the fourth quarter of 2025, reflecting three patient treatments in the first quarter of 2026 versus one patient treatment in the prior quarter.

Total research and development (R&D) expenses were $9.6 million for the first quarter of 2026 compared to $9.9 million in the first quarter of 2025. The first quarter of 2026 includes a single up-front payment of $7.0 million for in-licensing of the PSMA-SIR-T asset, now ABO-701. Excluding this transaction, R&D spending decreased by $7.4 million. The reduction in expenses was primarily due to costs capitalized into inventory and engineering runs and other production costs that are no longer considered research and development due to FDA approval of ZEVASKYN in April of 2025.

Selling, general and administrative (SG&A) expenses for the first quarter of 2026 were $19.5 million, a $9.7 million increase over the first quarter of 2025. This increase primarily reflects Abeona’s commercial transition following the April 2025 FDA approval of ZEVASKYN, including $5.4 million in personnel and stock-based compensation, $1.9 million of certain engineering and training expenses previously classified as R&D that were transitioned to SG&A post-approval, and the remainder due to other commercial costs related to ZEVASKYN.

Net loss was $(17.1) million for the quarter ending March 31, 2026, or $(0.30) per basic and diluted common share. Net loss for the first quarter of 2025 was $(12.0) million, or $(0.24) per basic and diluted common share.

Cash, cash equivalents and short-term investments totaled $168.3 million as of March 31, 2026, compared to $191.4 million as of December 31, 2025.

Conference Call Details

The Company will host a conference call and webcast on Wednesday, May 13, 2026, at 8:30 a.m. ET to discuss its financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free or, 973-528-0011 (international) and Entry Code: 305519 five minutes prior to the start of the call. A live, listen-only webcast with slides can be accessed on the Investors & Media section of Abeona’s website at View Source An archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, MAY 13, 2026, View Source [SID1234665620])

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.

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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.

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"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.

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"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.

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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])