2025 Annual Review

Happy, happy 2026, Hope community!

One of our favorite parts of welcoming a new year is to reflect on the period concluding. There are many ways to present annual reviews, and in the near-decade since our founding we have tried many, from formal materials and presentations to stakeholder reports. This year, however, we’re trying something new – we want to celebrate the year with those who made it possible, in plain language. We want to celebrate with you.

If you prefer to listen or watch your news, please tune in to the latest episode of Stem Cell Revolution for the “top three” moments that defined the year (and a bonus!), clinical research and other programmatic updates, and a few stats that may surprise you:

For even more to celebrate, keep reading!

2025’s Major Milestones

Hope Bio was privileged to mark several tremendous occasions this year, some many years in coming to fruition and some evolving seemingly suddenly. As shared in the video above, major milestones in 2025 include:

A spring visit to HHS.

In March, CEO Donna Chang received an invitation to contribute to a Secretary of Health-initiated roundtable on issues related to biologics availability in the U.S., including regulation. This was the first time Hope Bio has been formally invited to contribute to national dialogue.

Tune in to this podcast for more details about the trip to Washington:

RMAT designation in Multiple Sclerosis (MS)

In late August, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for Hope Biosciences’ adipose-derived mesenchymal stem cells (HB-adMSCs) for treatment of patients living with relapsing-remitting multiple sclerosis (RRMS), based on research conducted by Sugar Land-based non-profit clinical research organization Hope Biosciences Research Foundation (HBRF). This marks the first RMAT designation for multiple sclerosis, making it major news not only for the company but for millions of suffering people.

To qualify for RMAT, a therapy must demonstrate preliminary clinical evidence of addressing a serious or life-threatening condition with significant unmet medical needs. The process requires compelling proof that the therapeutic has potential to substantially improve patient outcomes where existing treatments fall short. RMAT designation grants eligibility for priority review or accelerated approval, including enhanced FDA collaboration.

Looking ahead, Hope Bio “remains focused on getting treatment to people in need and will move rapidly to collaborate with FDA on advancing access, including filing our Biologics License Application. We also look forward to participation in the Chemistry, Manufacturing, and Controls Development and Readiness Pilot program, at FDA’s invitation.” 

We bought the building! Literally.

Also in the fall, Hope Bio officially put down roots in Sugar Land through the purchase of our building. If you've visited recently, we are now easier to find than ever, thanks to a sparkling new sign!

January 2026 update: we can now joyfully share that

Click here to read the City's announcement and get all the details.

Bonus!

In a moment of deep importance to our team members, especially those who have been here for many years, two individuals received their 100th infusions in 2025 (both have since received more). Administration of more than 100 infusions to a single individual is validation of safety and replicability of Hope's technology, and a moving milestone moving to experience in fruition.

End of Year Research Notes

As 2025 closes, Hope Bio's cells are involved in research underway in hospital, academic, and independent non-profit clinical research settings in multiple states.

Exciting news came at the end of the year, when research site Hope Biosciences Research Foundation (HBRF) announced promising topline results in a Phase II trial in Parkinson's Disease. The sixty-patient, double-blind, placebo-controlled trial successfully met its primary endpoint, demonstrating statistically significant improvements in motor function for the treatment group compared to the placebo group. Results are currently in detailed analysis, expected to be publicly available in the first half of 2026.

Expanded Access continued throughout the year in patients living with ataxia and spinal cord injury. News alert! Look for an announcement early in 2026 about Expanded Access for Multiple System Atrophy (MSA), the first multi-patient protocol of its kind and also noteworthy for including multiple intrathecal administrations in the trial design. Also look for enrollment to begin for an open label Phase Ib/IIa clinical trial sponsored by the Weston Brain Institute in Canada and conducted at UTHealth Houston to evaluate whether Hope Bio's cells reduce inflammation in the brain, improve brain activity, and/or slow progression of Alzheimer's Disease.

As of this writing, enrollment continues for a Phase II trial in Crohn's Disease at HBRF, and for a Traumatic Brain Injury run by UTHealth Houston enrolling in both Houston and San Antonio. Check out the video for more:

Keep up!

Want to stay up-to-date on all things Hope-ful and Hope-filled in the new year? Subscribe to Stem Cell Revolution Podcast on YouTube or Spotify, and launch into 2026 with us. Here's to another powerful year of Hope!