Halia Therapeutics to Present Final Phase 2 Ofirnoflast Data in Lower-Risk MDS at EHA2026 and Announces Appointment of Han Myint, MD, FACP, as Chief Medical Officer

European Hematology Association (EHA) oral presentation to report 67% hematological improvement, durable transfusion independence, and no treatment-related serious adverse events in ESA-refractory lower-risk MDS

Dr. Myint, a hematology leader and oncology drug-development executive, joins Halia to lead clinical development as ofirnoflast (HT-6184) advances toward pivotal trials

LEHI, Utah, May 12, 2026 /CNW/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company developing first-in-class therapies targeting the NLRP3 inflammasome and related inflammatory pathways, today announced final Phase 2 results for ofirnoflast (HT-6184) in patients with lower-risk myelodysplastic syndrome (LR-MDS). The data will be presented in an oral session at the European Hematology Association (EHA) 2026 Hybrid Congress, June 11–14, 2026, in Stockholm, Sweden. The accepted abstract is available today on the EHA Congress platform.

The company also announced the appointment of Han Myint, MD, FACP, as Chief Medical Officer. Dr. Myint will lead Halia's global clinical development, medical affairs, and safety strategy as the company prepares to advance ofirnoflast into pivotal development and progresses its broader pipeline grounded in human genetic resilience and innate immune biology.

Final Phase 2 Results to Be Presented at EHA2026

The open-label, single-arm Phase 2 trial enrolled 37 adults with IPSS-R very low- to intermediate-risk MDS (score ≤4.5) who had symptomatic anemia or red blood cell (RBC) transfusion dependence and were refractory to, intolerant of, or ineligible for erythropoiesis-stimulating agents (ESAs). Ofirnoflast was administered orally at 2 mg once daily on a 5-days-on/2-days-off schedule for up to 32 weeks. The primary endpoint was hematological improvement (HI) per IWG 2018 criteria. Highlights from the accepted abstract include:

• 67% overall HI rate among 30 evaluable patients, with multilineage activity: 62% HI-E, 60% HI-P, and 50% HI-N
• 55% RBC transfusion independence for ≥8 weeks among transfusion-dependent patients (10/18), with 39% sustained for ≥16 weeks
• Median duration of transfusion independence of 28.5 weeks
• 75% HI-E among non-transfusion-dependent patients (9/12)
• Median hemoglobin rise of 4.5 g/dL in HI-E and transfusion-independence responders (range 0.1–7.1 g/dL)
• No treatment-related serious adverse events; treatment-related adverse events occurred in 27% of patients, with a single Grade ≥3 event (hypertension)
• Activity observed across WHO MDS subtypes and mutational backgrounds, including patients with and without SF3B1 or del(5q)

Additional efficacy, safety, biomarker, and quality-of-life data will be presented at the EHA2026 Congress.

"These final Phase 2 results validate our approach of targeting upstream innate immune biology in lower-risk MDS," said David J. Bearss, Ph.D., President, Chief Executive Officer, and co-founder of Halia Therapeutics. "Ofirnoflast has demonstrated durable transfusion independence, multilineage hematological improvement, and a favorable safety profile in a patient population with significant unmet need."

Han Myint, MD, FACP Appointed Chief Medical Officer

Dr. Myint brings more than three decades of experience spanning academic medicine,  biotechnology and global pharmaceutical organizations, with deep expertise in hematologic malignancies, oncology drug development and late-stage clinical strategy.

Dr. Myint is an internationally recognized hematologist-oncologist and biopharmaceutical executive with more than three decades of experience spanning academic medicine, biotechnology and large pharmaceutical organizations. Throughout his career, he has led the development of innovative therapies across solid tumors, hematologic cancers and cellular immunotherapy programs, with experience advancing candidates from early-stage research through regulatory approval and commercialization.

"The addition of Han to our leadership team strengthens our ability to execute the next phase of the ofirnoflast development program with clinical and regulatory execution, as we advance toward pivotal development," continued Bearss. "He is one of the rare leaders who has worked across malignant hematology, global drug development, academic medicine, and late-stage commercialization. His experience in myeloid diseases, pivotal trial strategy, and regulatory engagement is directly aligned with where Halia is headed."

Commenting on his appointment, Dr. Myint said, "I am excited to join Halia at such a pivotal moment. The ofirnoflast Phase 2 data support a differentiated therapeutic approach in lower-risk MDS, where patients continue to need new oral options that can improve hematopoiesis and reduce transfusion burden. Halia's broader platform, rooted in human genetic resilience and innate immune biology, provides a compelling foundation for developing medicines across serious hematologic and inflammatory diseases. I look forward to advancing ofirnoflast and the pipeline through the next stages of clinical development."

About Han Myint, MD, FACP

Dr. Myint is a hematologist-oncologist and drug-development leader with more than 30 years of experience across academia, biotechnology, and global pharmaceutical organizations. Previously, he was Chief Medical Officer of NextCure, Inc., overseeing first-in-human and proof-of-concept oncology trials, and Chief Medical Officer of NexImmune, Inc., a clinical-stage developer of T cell–based immunotherapies.

Earlier in his industry career, Dr. Myint held senior leadership roles at Celgene Corporation (now part of Bristol Myers Squibb), including Global Myeloid Disease Lead and Co-Chair of the Global Myeloid Franchise Team, where he contributed to the development, approval, and global launch of therapies for myeloid diseases including Thalassemia, MF, MDS and AML.

Before transitioning to industry, Dr. Myint was an academic hematologist-oncologist and stem cell transplant physician. He served as Professor of Medicine and Director of Stem Cell Transplantation and the Hematological Malignancies Program at the University of Colorado, Denver, where he built a FACT-accredited and Center of Excellence-designated stem cell transplant program. He previously held academic leadership roles at Rush University Medical Center. Dr. Myint received his MBBS from the Institute of Medicine in Yangon and completed postgraduate training in internal medicine and hematology in the United Kingdom, followed by advanced hematology/oncology and stem cell transplantation training in the United States. He is a fellow of the Royal College of Pathologists, London, UK, Royal College of Physicians & Surgeons, Glasgow, Royal College of Physicians of Edinburgh, and American College of Physicians.

EHA2026 Presentation Details

Title: Ofirnoflast, a First-in-Class NEK7 Inhibitor, Induces Robust Transfusion Independence and Multilineage Hematological Improvement in Lower-Risk Myelodysplastic Syndrome (LR-MDS): Phase 2 Results
Abstract number: S174
Session: Oral Session s426 -- Myelodysplastic Syndromes – Clinical
Presenting author: Varun Bafna, MD
Date and time: Friday, June 12, 2026, 17:15–18:30 CEST
Location: A2-3 Hall, Stockholmsmässan, Stockholm, Sweden, and virtual on the EHA Congress platform

About Ofirnoflast (HT-6184)

Ofirnoflast is Halia's first-in-class, oral, allosteric NEK7 inhibitor designed to modulate NLRP3 inflammasome activation upstream of inflammatory signaling. By targeting NEK7 before NLRP3 assembly, ofirnoflast prevents inflammasome formation and disrupts a key pathway implicated in ineffective hematopoiesis. Halia is advancing ofirnoflast as a potential disease-modifying therapy for lower-risk MDS, with broader development opportunities across inflammasome-driven diseases.

About Halia Therapeutics

Halia Therapeutics is a clinical-stage biotechnology company headquartered in Lehi, Utah, developing first-in-class therapies that target inflammasome-driven disease biology. The company is focused on addressing significant unmet medical needs in hematologic diseases through novel mechanisms of action designed to target the root causes of inflammation-driven pathology. Halia's lead program, ofirnoflast, is being developed for lower-risk MDS and other hematologic diseases driven by NLRP3 inflammasome biology. Its broader pipeline is grounded in human genetic resilience and precision medicine. For more information, visit www.haliatx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the potential clinical, therapeutic, and commercial benefits of ofirnoflast (HT-6184); the timing and content of upcoming scientific presentations; the design, timing, and outcomes of current and future clinical trials; regulatory plans and interactions; the appointment and expected contributions of Halia's Chief Medical Officer; and the company's pipeline and development strategy. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," and similar expressions are intended to identify forward-looking statements. Forward-looking statements are based on Halia's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to clinical development, regulatory review, manufacturing, financing, competition, intellectual property, personnel, and general business conditions. Halia undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

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SOURCE Halia Therapeutics