RESTEM Provides Corporate Update and Announces Strategic Priorities for 2026

MIAMI, Jan. 08, 2026 (GLOBE NEWSWIRE) — RESTEM – a clinical-stage biotechnology company that develops off-the-shelf, next-generation cell therapies designed to modulate the immune system, today provided a corporate update and announced its strategic priorities for 2026.

“We had a remarkable 2025, where we made significant progress across our pipeline of advanced cell therapeutics. In particular, we have further expanded the evidence supporting the superior immunomodulatory capabilities and safety profile of Restem-L,” said Andres Isaias, Chief Executive Officer of RESTEM. “We have initiated the clinical trial of Restem-L in facioscapulohumeral muscular dystrophy (FSHD) and have started screening patients for the Phase 2/3 clinical trial in idiopathic inflammatory myopathy (IIM) and anticipate these patients to be enrolled in the coming weeks. We also received FDA clearance for the evaluation of Restem-L in rheumatoid arthritis (RA) and expect to initiate Phase 2/3 clinical trial in the first half of 2026. As we look ahead, we are excited for a milestone-rich 2026 and remain committed to bringing our next-generation immunomodulatory treatment to the millions of patients suffering from autoimmune and inflammatory diseases.”

2025 Key Achievements and 2026 Anticipated Milestones

Clinical and Preclinical Programs

• IIM: Clinical trial sites for the Phase 2/3 IIMPACT clinical trial of RESTEM-L in adults with IIM are now open with several patients in screening and we anticipate these patients to be enrolled in the coming weeks. This Phase 2/3 pivotal trial is an adaptive, double-blinded, randomized, dose-repeating, crossover study aiming to enroll approximately 80 patients, with interim readout expected by the end of 2026.
• FSHD: Initiated the Phase 1/2a clinical trial of RESTEM-L in adults with FSHD in Q4 2025. The trial is funded by SOLVE FSHD and is a double-blind, randomized, dose-repeating, placebo-controlled, cross over study aiming to enroll 16 patients.
• Received U.S. Food and Drug Administration (FDA) clearance for Phase 2/3 clinical trial of Restem-L in RA; trial start-up activities are underway with the anticipated commencement in 1H 2026.
• Submitted IND for Phase 2 clinical trial of Restem-L in ulcerative colitis (UC); trial anticipated to begin in 2H 2026.
• Planned IND submission for Phase 1/2 clinical trial of Restem-X in osteoarthritis in Q1 2026.
• Completed production of:
  • Super-activated allogenic natural killer (aNK) cells; IND submission for a Phase 1 study in age-associated disorder is expected in 2H 2026.
  • aNK exosomes, a new asset in the aNK portfolio; pre-IND activities underway.

Corporate Highlights

• Strengthened patent portfolio with two new patents issued in the U.S., and three new patent applications filed. RESTEM currently has 14 issued patents worldwide and 12 pending patent applications. 
• Established a subsidiary to enable RESTEM clinical research in Australia. Australia’s strong regulatory environment, experienced clinical-trial networks, and the potential for refundable R&D tax will allow the Company to rapidly advance its pipeline.
• Appointed Jonathan Krant, MD, MPH, FACP, Rheumatologist at Monadnock Community Hospital, Peterborough, New Hampshire, to the Scientific Advisory Board.
• Hosted an R&D Investor Day in September 2025 featuring presentations by key opinion leaders Guenther Koehne, MD, PhD, Miami Cancer Institute, Jonathan D. Krant, MD, MPH, FACP, Monadnock Community Hospital, and Eva Chin, PhD, SOLVE FSHD. The event spotlighted Restem-L’s superior immunomodulatory and safety profile and its potential as a therapy for autoimmune and inflammatory diseases, including IIM, RA, UC and FSHD.

Conference Presentations and Participation

• Delivered an oral presentation on the Phase 2/3 IIMPACT clinical trial design of Restem-L in IIM at the European Alliance of Associations for Rheumatology’s (EULAR) 2025 Congress. The presentation was one of the 15 presentations featured in EULAR 2025: Highlights from Clinical Science.
• Presented at the 2025 BIO International Convention in June 2025 and Jones Las Vegas Technology and Innovation Conference, and participated in JP Morgan Healthcare Conference and Biocom Global Life Science Partnering and Investor Conference.

About RESTEM

RESTEM is a leading clinical-stage biotechnology company focused on developing off-the-shelf, next-generation cell therapies for autoimmune, inflammatory, and age-related diseases. Leveraging proprietary products, deep clinical expertise, and advanced manufacturing capabilities, RESTEM is advancing two potentially transformative programs, Restem-L, our umbilical cord lining progenitor cells (UMPCs) therapy for autoimmune diseases, and activated natural killer cell (aNK) therapeutics targeting senescence and age-associated disorders. Our therapies are designed to reprogram the immune system rather than focusing solely on symptom management, offering patients with limited options the potential to address underlying disease mechanisms. RESTEM is headquartered in Miami, Florida. For more information, please visit www.restem.com and follow us on X and LinkedIn.

Investor Contact

Daniel Ferry
LifeSci Advisors
+1.617.430.7576
daniel@lifesciadvisors.com

Media Contact

Nelson Cabatuan
Restem Group, Inc.
+1.800.490.0924
ncabatuan@restem.com