DiscGenics Announces Independent DSMB Safety Review Supports Continuation of Phase III Study of IDCT Without Modifications

June 11, 2026

Salt Lake City, Utah – June 9, 2026 – DiscGenics, Inc., a privately held, late-stage clinical biopharmaceutical company developing allogeneic, cell-based, regenerative therapies for musculoskeletal degeneration, today announced that the independent Data Safety Monitoring Board (“DSMB”) for its Phase III clinical study of IDCT, also known as rebonuputemcel, for the treatment of symptomatic lumbar degenerative disc disease (“DDD”), has completed a pre-planned safety review and recommended that the study proceed without any modifications.

The DSMB review was conducted as part of the pre-planned clinical safety oversight process agreed upon with the U.S. Food and Drug Administration (“FDA”). Following its review of available safety data, the DSMB recommended continuation of the study as planned, with no changes to the study protocol.

“This DSMB recommendation marks an important milestone for DiscGenics as we continue advancing IDCT through Phase III clinical development,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “We are pleased that the independent safety review supports continuation of the study without modifications, consistent with the pre-planned oversight framework agreed upon with the FDA. This recommendation further reinforces our confidence in the clinical development path for IDCT and our commitment to bringing forward a potential regenerative treatment option for patients suffering from symptomatic lumbar disc degeneration.”

IDCT is a standalone, single-injection biologic treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out. DiscGenics is evaluating IDCT in a Phase III clinical study designed to assess the safety and efficacy of the investigational therapy in adults with symptomatic lumbar DDD.

“Since the inception of DiscGenics, we have generated a robust body of preclinical and clinical evidence supporting the safety profile and regenerative potential of IDCT,” said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics and Chairman of Semmes-Murphey Neurologic & Spine Institute. “The DSMB’s recommendation to proceed without modifications is an encouraging outcome from this pre-planned review and allows us to continue the Phase III study as designed.”

DDD is a chronic and progressive condition where the intervertebral disc breaks down and causes pain and disability. It accounts for nearly 40% of chronic low back pain cases in the U.S., a serious medical condition that affects 12-30% of U.S. adults at a given time and is estimated to cost the U.S. healthcare system over $100 billion each year, creating a considerable burden on the economy and individual patients.

“The ability to continue this Phase III study without modification is an important step as we work to further evaluate IDCT’s potential to change the paradigm of care for patients with DDD,” said Flanagan.

About the Phase 3 Study

The Phase 3 clinical research study is evaluating IDCT as a non-surgical treatment under investigation for degenerative disc disease of the lower spine. The website is intended to support awareness and pre-screening for potential participants.

You May Qualify If You:

• Are 18–75 years old

• Have had chronic low back pain for 6 months or longer

• Have lumbar degenerative disc disease, diagnosed or suspected

• Are able to return for follow-up visits for about 2 years

To learn more or complete the pre-screen, visit DDDtrial.com.

About DiscGenics

DiscGenics is a privately held, late-stage clinical, biopharmaceutical company developing cell-based regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics’s first product candidate, IDCT (rebonuputemcel), is an allogeneic, injectable discogenic progenitor cell therapy for symptomatic, lumbar disc degeneration. IDCT is a mixture of live Discogenic Cells, which are a manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, and a viscous carrier. IDCT has been granted regenerative medicine advanced therapy (RMAT) and Fast Track designations by the U.S. Food and Drug Administration. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics has a unique opportunity to offer a non-surgical, potentially regenerative solution for the treatment of patients suffering from the debilitating effects of back pain.

DiscGenics has developed a proprietary, commercial-scale, in-house allogeneic cell manufacturing process and built and qualified a cGMP facility at its Salt Lake City, Utah headquarters.

For more information, visit discgenics.com

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the therapeutic potential, regulatory status, commercialization timing, market opportunity, post-marketing commitments, and future development of IDCT. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including regulatory developments, clinical outcomes, manufacturing readiness, reimbursement decisions, commercialization execution, and other factors. DiscGenics undertakes no obligation to update these statements except as required by law.