Remains on track to name a development candidate for a novel first-in-class neurology program targeting demyelinating diseases in 2026 Progresses discovery workRemains on track to name a development candidate for a novel first-in-class neurology program targeting demyelinating diseases in 2026 Progresses discovery work

GC Therapeutics Appoints Kate Haviland as Board Chair and Provides Corporate Update

  • Remains on track to name a development candidate for a novel first-in-class neurology program targeting demyelinating diseases in 2026
  • Progresses discovery work on a best-in-class cell therapeutic approach for treating Type 1 Diabetes
  • Advancing TFome™ cell programming platform to enable next-generation cell therapies and is positioned to expand into in vivo reprogramming

CAMBRIDGE, Mass.–(BUSINESS WIRE)–GC Therapeutics, Inc. (GCTx), a biotechnology company created to scale and unlock the next generation of cell therapy-based medicines through its TFome™ cellular programming platform, today announced a series of corporate and pipeline updates.

GCTx unveiled its initial pipeline programs focused on demyelinating neurological disorders, including multiple sclerosis (MS), and a regenerative cell therapy program for metabolic diseases, including Type 1 Diabetes. Both programs leverage the modularity and scalability of the TFome™ platform, the world’s first “plug-and-play” cellular programming system designed to streamline development, manufacturing, and regulatory engagement.

The company also announced productive interactions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The regulators endorsed the TFome™-enabled development model and supported a streamlined regulatory pathway across the pipeline. In addition, GCTx appointed Kate Haviland as chair of its Board of Directors. Ms. Haviland brings decades of leadership experience in biotechnology, including her tenure as president and chief executive officer of Blueprint Medicines.

The company completed its first Cell State Cookbook™ (CSC™), mapping epigenomic transitions across more than 300 human cell states and testing over two million transcription factor combinations in living human cells. Powered by AI foundation models validated in closed-loop biology, the TFome™ and CSC™ platform enables precision cell state engineering and supports expansion across cell therapy, in vivo reprogramming, and rejuvenation.

“For decades, cell therapy has relied on trial-and-error approaches to cell identity,” said Parastoo Khoshakhlagh, Ph.D., co-founder and chief executive officer of GCTx. “At GCTx, we are replacing that paradigm with a system that learns from biology at scale and translates those into new classes of medicines. The progress we are announcing today, from the maturation of our pipeline programs to encouraging feedback from global regulators, marks a key turning point for cell therapy. We believe this reflects a new standard for cell state control that is predictable, manufacturable, and extensible across both cell therapy and in vivo reprogramming. With Kate joining us as chair of our Board, we are exceptionally well positioned to sustain our rapid growth and advance our first program into the clinic, where we expect to unlock the full value of our platform.”

“GC Therapeutics is tackling the most persistent challenges in cell therapy with a platform that is both scientifically compelling and operationally scalable,” said Kate Haviland, chair of the board of GCTx. “The company’s approach to cellular programming, manufacturing, and regulatory strategy positions it as a leader who can meaningfully expand patient access to transformative therapies. I am excited to support the team as they move into the clinic.”

Kate most recently served as the president and chief executive officer of Blueprint Medicines, having also held the previous roles of chief operating officer and chief business officer, until Blueprint’s acquisition by Sanofi in 2025. Prior to joining Blueprint Medicines, Kate held leadership roles focused on building emerging, high-growth companies and advancing the development of innovative therapies in oncology and rare diseases across multiple organizations including Idera Pharmaceuticals, Sarepta Therapeutics, PTC Therapeutics and Genzyme. Kate currently serves as chair of the board of directors at Fulcrum Therapeutics, as an independent director on the board of directors at Bicara Therapeutics, as a member of the board of directors at Biotechnology Innovation Organization (BIO) and as a trustee of the Boston Museum of Science.

Kate holds an MBA from Harvard Business School and received her B.A. from Wesleyan University with a double major in biochemistry/molecular biology and economics.

About TFome™, the world’s first “plug-and-play” cellular programming platform

Induced pluripotent stem cell (iPSC) differentiation into distinct cell types depends on various signaling pathways that ultimately converge onto transcription factors (TFs), which control the sets of genes that are active in a cell. Cell fate is determined by specific TFs acting in concert.

GCTx has built the world’s first complete collection of human TFs. Through sophisticated multidimensional screening modalities that integrate genome-scale experimental testing and powerful next-generation predictive AI foundation models informed by GCTx’s proprietary data, TFome™ has been proven to identify fully optimized TF combinations to differentiate iPSCs into virtually any functional cell type. This allows for a single-step, four-day stem cell differentiation process with >90% efficiency with no requirement for cell type-specific optimization for microenvironmental factors. This has not been achieved previously via conventional small-scale testing. TFome™ also enabled the construction of the Cell State Cookbook™ (CSC™) to build the epigenomic transition matrix which is positioned to precisely engineer any cell state for in vivo reprogramming.

Through TF-based cell fate programming, TFome is designed to yield first-in-class and best-in-class off-the-shelf cell therapy products up to 100 times more rapidly than conventional methods of cell differentiation with improved potency, efficiency, quality and cost (SuperCells™). GCTx is positioned to be the first company in the iPSC-based cell therapy space to pursue multiple cell products from one starting point using a similar manufacturing strategy for more accelerated development and timelines. GCTx has built the largest empirical map of TF-driven cell state transitions, the CSC™, based on data from over two million tested TF combinations. The CSC™ powers compounding predictive AI foundation models that capture key features of cell state control and enable rapid identification of optimized TF programs, significantly streamlines discovery for cell therapy development and in vivo reprogramming.

TFome™ was invented and developed by a world-class team of scientists in the lab of professor George Church, Ph.D., at Harvard Medical School and the Wyss Institute.

About GC Therapeutics

GC Therapeutics (GCTx) is a biopharmaceutical company created to scale and unlock the next generation of cell therapy-based medicines. GCTx’s induced pluripotent stem cell (iPSC) programming platform, TFome™, integrates the latest advancements in synthetic biology, gene editing, cell engineering and machine learning to overcome the therapeutic development and scaling complexities associated with cell therapy and improve patient access across a broad range of disease areas. GCTx’s initial focus is on developing first-in-class and best-in-class cell therapies for neurological and metabolic diseases with potential for expansion into other therapeutic modalities. Founded in 2019, GCTx is based in Cambridge, MA and has raised $75 million to date from leading life sciences investors. For more information, please visit us at www.gc-tx.com and follow us on LinkedIn and X.

Contacts

Media:
Katie Engleman

1AB

katie@1abmedia.com

Investors:
Vivian Zou

GC Therapeutics

IR@gc-tx.com

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