Cartherics and Catalent Expand Commercial License Agreement

April 9, 2026 - Melbourne, Australia, and Tampa, FL - Cartherics Pty Ltd, a biotechnology company developing off-the-shelf immune cell therapies for high-impact women's diseases, including ovarian cancer and endometriosis, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, today announced an enhanced partnership. The companies have signed an amended commercial license agreement enabling the use of a Catalent cGMP-compliant induced pluripotent stem cells (iPSC) line for the manufacture and commercialization of Cartherics' iPSC-derived Chimeric Antigen Receptor Natural Killer (CAR-NK) cell therapies. The agreement supports Cartherics' mission to develop immune cell therapy products for the treatment of cancer and endometriosis.

Dr. Ian Nisbet, CEO of Cartherics, commented, "We are delighted to have established a collaborative relationship with Catalent, a leading cell and gene therapy CDMO, to expedite the development of our CAR-NK cell products. We are confident that our collaboration with Catalent will underpin cost-effective manufacturing of our products."

"We are thrilled to broaden our partnership with Cartherics and support the important work the company is doing to develop Natural Killer cells for the treatment of cancer," said David McErlane, Biologics Group President for Catalent. "Our teams are highly engaged in achieving positive outcomes across all stages of development, and we look forward to advancing Cartherics' program toward commercialization.

Under the terms of the agreement, Cartherics is granted rights to develop and commercialize multiple product candidates derived from a Catalent off-the-shelf cGMP iPSC line, including its lead CAR-NK cell product, CTH-401. The licensed iPSC line is part of a broader portfolio of fully characterized, donor-consented, clinical-grade iPSC lines generated under GMP conditions, supported by validated workflows for reprogramming, expansion, gene editing, differentiation and quality control.
With Catalent's support, Cartherics has already obtained approval from the U.S. Food and Drug Administration (FDA) for use of the licensed iPSC line as the starting cell for generation of Cartherics' CTH-401. The two companies have also demonstrated full compatibility between CTH-401 and Catalent's iPSC-NK manufacturing platform.

The agreement enhances Cartherics' manufacturing capabilities by providing a robust framework for collaboration and incentives for utilizing Catalent as its contract manufacturing organization for late-stage clinical trials and commercial supply. Importantly, Cartherics retains the ability to manufacture clinical trial material and retains the right to participate in downstream manufacturing as the partnership evolves.

Both companies view this collaboration as an important step forward in delivering innovative cell therapy solutions to improve patient outcomes around the world.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers' needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

For more information, visit https://www.catalent.com.

About Cartherics

Cartherics Pty Ltd is a privately held biotechnology company based in Melbourne, Australia developing off-the-shelf immune cell therapies focusing on high-impact women's diseases, with lead programs in ovarian cancer and endometriosis. The Company's allogeneic ("off-the-shelf") cell platform is based upon induced pluripotent stem cells (iPSCs) generated from donated cord blood that can be differentiated into NK cells, T cells and other cells of the immune system. The iPSCs are genetically engineered at specific "safe harbour" genomic sites to provide enhanced function for the derived NK and other immune cells.  The Company's lead product, CTH-401, is a CAR-iNK cell product.  It carries a CAR directed against TAG-72, a well-validated tumour target, along with the deletion of two genes associated with immunosuppression.  The company has a strong pipeline of additional novel CAR-immune cell products tailored to disrupt a variety of cancers including; ovarian, triple negative breast cancer and other solid tumours; and is also targeting severe endometriosis with specific NK cell products.

https://cartherics.com/

Watch our latest company video here: https://www.youtube.com/watch?v=rxQEyx6i7hk

CONTACTS

Catalent:
[email protected]

Cartherics:
Christine Filippis
Teraze Communications
Phone: +61 419 119 866
Email: [email protected]