Highlights

  • Clinical Trial Application submitted in Europe for the first-in-human Phase 1 study of DEP® HER2-Lu, with non-radiolabelled clinical material manufactured.
  • After quarter end, Starpharma lifted its interest in Petalion Therapeutics from 22.5% to 66%, taking majority ownership of the FAP-targeted DEP® oncology program.
  • The $32 million fully underwritten entitlement offer extends the cash runway into FY28, and the AUD $0.5 million Radiopharm option fee was received.
  • Cash was $34.4 million at 30 September 2026, with a pro forma $37.9 million including the $3.5 million R&D tax incentive received on 22 October.

Starpharma (ASX:SPL) (US OTC: SPHRY) has released its Quarterly Activities Report and Appendix 4C for the quarter ended 30 September 2026 (Q1 FY27). The biotechnology company reported progress towards first-in-human testing of its lead radiopharmaceutical program, DEP® HER2-Lu, secured majority ownership of Petalion Therapeutics and strengthened its balance sheet through a $32 million entitlement offer.

DEP® HER2-Lu Moves Towards the Clinic

Following quarter end, Starpharma submitted its Clinical Trial Application through the European Union Clinical Trials Information System for approval to run the first-in-human Phase 1 study in the Netherlands. During the quarter it completed manufacture of the non-radiolabelled DEP® HER2-Lu clinical material and advanced the validation of the radiolabelling process.

The study will be conducted with University Medical Center Groningen. Its initial stage is designed to evaluate safety and tolerability and to characterise biodistribution, tumour uptake, pharmacokinetics and radiation dosimetry in patients with HER2-expressing cancers. First patient dosing remains subject to regulatory approval and site start-up. Starpharma also filed a new patent application covering DEP® dendrimer use in radioligand therapy, following preclinical data across targets including HER2, PSMA and EGFR.

Petalion, Genentech and Radiopharm Partnerships

Starpharma increased its equity interest in Petalion Therapeutics from 22.5% to 66%, securing governance control and operational leadership of the FAP-targeted DEP® oncology program. Medicxi retains 30% and a board role. Starpharma will contribute up to AUD $5.0 million, made up of AUD $3.0 million in cash and up to AUD $2.0 million in R&D services.

Research continued under the Genentech collaboration, and a milestone under the Radiopharm Theranostics agreement triggered the AUD $0.5 million option fee, received in July 2026. If Radiopharm exercises its option, Starpharma would be eligible for up to AUD $91 million in upfront and milestone payments plus royalties on net sales.

Cash Position, Funding and Leadership Changes

Cash ended the quarter at $34.4 million, with customer receipts of $1.0 million. Net operating cash outflow was $5.9 million, which the Appendix 4C equates to an estimated 5.9 quarters of funding. R&D costs were $2.6 million, including upfront clinical study costs, and staff costs were $3.3 million. The $32 million entitlement offer completed in August extends the runway into FY28.

On governance, Rob Thomas AO will retire as Chair at the conclusion of the November 2026 AGM after 12 years, with Dr Russell Basser and David McIntyre to become Chair and Deputy Chair respectively. The Board has asked Mr Thomas to continue as a non-executive director, subject to shareholder approval.

Key Takeaways

Starpharma is shifting from preclinical work to clinical-stage execution in targeted oncology, backed by a refreshed balance sheet and a larger stake in Petalion. Key milestones to watch include European regulatory approval for the HER2-Lu study, site start-up, Radiopharm’s option decision and progress on the FAP program. As with any clinical-stage biotech, outcomes are uncertain and subject to regulatory approval. This article is general information only and is not financial advice.