BioOra signs definitive licence for WZTL-002 and announces NZ$30 million First Close of Series A2

Licence secures the foundation of atla-cel, BioOra's lead CAR T-cell therapy, as the company funds its path towards a public listing

Wellington, New Zealand – BioOra Limited, the leading New Zealand developer and manufacturer of CAR T-cell therapies, today announced that it has completed a definitive licence with Wellington Zhaotai Therapies Limited (WZTL) for exclusive rights to develop and commercialise its third-generation anti-CD19 CAR T-cell therapy (WZTL-002), and has completed the first close of its Series A2 funding round with secured commitments of NZ$30 million.

 

WZTL is a New Zealand-incorporated joint venture, established in 2017 between Hunan Zhaotai and the Malaghan Institute of Medical Research, to develop advanced cell therapies. WZTL-002, developed by the joint venture, is a third-generation anti-CD19 CAR T-cell therapy and is manufactured by BioOra as atlacabtagene autoleucel (atla-cel). Atla-cel is an autologous CAR-T product that incorporates the underlying WZTL-002 construct alongside BioOra’s manufacturing and release expertise in cell therapies. BioOra is currently supplying atla-cel for a New Zealand clinical trial (ENABLE-2) that is sponsored by the Malaghan Institute for adults with relapsed or refractory large B-cell lymphoma.

The licence executed today secures BioOra's rights to the underlying CAR-T construct for future development including for haematological malignancies and auto-immune diseases. This applies in all markets outside of China and India, including the USA, Europe, and the UK. BioOra can now prepare to expand into other markets outside of New Zealand and Australia.

The first close was supported by existing shareholders and new investors, with considerable additional capital provide by two major investors, Bridgewest Ventures and Cincinnati Children’s Hospital Medical Center. BioOra expects to hold a second close by the end of December 2026, with the round targeting a total of NZ$45 million. Series A2 is intended as BioOra's last private raise before a planned public listing on the ASX in 2028. Proceeds of the A2 round will support completion of manufacturing of atla-cel for the ENABLE-2 clinical trial, regulatory filing of atla-cel with Medsafe and completion of the BioOra Health & Technology Centre, BioOra’s commercial manufacturing facility in Christchurch. The agreement and Series A2 close readies BioOra for wider public access of novel cell and gene therapies, expansion into Queensland, and the partnership with Cincinnati Children’s Hospital for development of atla-cel for paediatric acute lymphoblastic leukaemia.

"This licence secures the science that atla-cel is built on, and our first close gives us the resources to keep delivering for patients", said John Robson, Chief Executive Officer of BioOra. "I thank our colleagues at WZTL, Hunan Zhaotai, and the Malaghan Institute for their good faith and partnership, and our shareholders for their continued confidence".

 

Financial terms have not been disclosed, but under the agreement, Wellington Zhaotai will receive an upfront cash payment and equity in BioOra Limited, together with royalties on future product sales. This provides Wellington Zhaotai with the opportunity to participate in the future commercial success of WZTL-002 in major international markets as directed by BioOra.

 

“This is a milestone deal that sees science developed in a unique partnership with the Malaghan Institute and Wellington Zhaotai becoming available as a global treatment, born from New Zealand innovation and taken to the world through perseverance and passion for better patient outcomes”, said Dr Crabtree, Chairman of BioOra Limited.

 

Mr Zhaoyang Tang, Chairman of Wellington Zhaotai, said, “We look forward to working with BioOra to develop new opportunities for industry development in New Zealand, to translate research into treatments, and give more patients the opportunity to benefit from our technologies”.

 

To mark the occasion, the Parties invited BioOra’s first employee, Alexandra Galbon, Head of Business Operations and Strategy, to co-sign the agreement, together with Chief Executive, John Robson and Mr Zhaoyang Tang, Chairman of Wellington Zhaotai and Mr Mike Zablocki, Director of Wellington Zhaotai.

 

About BioOra

BioOra is a cell therapy company headquartered in Wellington, New Zealand, focused on bringing transformative immunotherapies to patients across New Zealand, Australia, and beyond. The company is commercialising CAR-T therapies for haematologic malignancies while building regional infrastructure for the manufacturing of advanced cell therapies.

Atla-cel is a CD19-targeted CAR-T therapy for relapsed or refractory B-cell lymphoma, based on the WZTL-002 construct, and delivers a treatment to a significant unmet medical need. The ongoing ENABLE-2 Phase 2 trial is over halfway enrolled, supporting BioOra’s path towards regulatory approval and commercialisation beginning with New Zealand. Atla-cel forms a core pillar of BioOra’s strategy to establish a regional hub for advanced cell therapy manufacturing spanning New Zealand, Australia, and ultimately global markets.

 

About Wellington Zhaotai Therapies Limited

Wellington Zhaotai Therapies Limited is a New Zealand-incorporated cell therapy company established in 2017 by Hunan Zhaotai Enterprise Management Limited (Zhaotai) and the Malaghan Institute of Medical Research to develop and commercialise differentiated CAR T-cell therapies for international markets. The joint venture was founded on a proprietary third-generation Chimeric Antigen Receptor (CAR) construct incorporating intracellular signalling domains which serve to preserve or enhance anti-tumour activity while improving safety outcomes relative to earlier generation CAR constructs.

Through its shareholder Zhaotai, Wellington Zhaotai has access to a broad innovation platform of translational research, clinical development and manufacturing capability in China that has delivered a substantive suite of innovative cell therapies, designed to treat a range of diseases including haematological cancers, auto-immune diseases and solid tumours. Together with its licensees and collaborators, Wellington Zhaotai’s mission is to turn differentiated cell therapy innovation into commercially scalable treatments for patients in global markets.

For media interviews: 

John Robson

Chief Executive Officer

BioOra Limited

+64 21 842 960

investments@bioora.com

 

 

 

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