Starpharma has confirmed FDA alignment for its DEP® HER2 first-in-human phase 1 trial, with preparations underway for a mid-2026 start. The biotech also progressed strategic partnerships, published promising data with Genentech, and reported a $14.1 million cash balance alongside rising Viraleze™ sales.
- FDA confirms DEP® HER2 phase 1 clinical plan
- Strategic partnerships advance with Genentech data published
- Viraleze™ sales up 65% year-to-date
- Quarter-end cash balance of $14.1 million
- Net operating cash outflow of $3.9 million for quarter
FDA Endorsement Clears Path for DEP® HER2 Phase 1 Trial
Starpharma (ASX:SPL) has secured a critical regulatory green light, confirming alignment with the US Food and Drug Administration (FDA) on the clinical development strategy for its DEP® HER2 radiopharmaceutical candidate. This endorsement follows a Type C guidance meeting in April, where the FDA validated the preclinical data package and study design, paving the way for a first-in-human (FIH) phase 1 trial targeting advanced HER2-expressing cancers. The trial is on track to commence in Europe in the second half of calendar year 2026, with clinical site selection and regulatory preparations well advanced.
The FDA’s recognition of the significant unmet medical need in this patient population adds strategic value to DEP® HER2, a lutetium-177 radionuclide conjugate designed for patients who have exhausted prior HER2-targeted therapies. This regulatory clarity is a pivotal milestone as Starpharma transitions its radiopharmaceutical program from preclinical development into clinical evaluation, confirming the robustness of its approach and opening potential pathways for expedited development.
Partnership Momentum Bolstered by Published Genentech Data
Starpharma continued to strengthen its commercial and research collaborations during the quarter, notably publishing data from its early-stage research partnership with Genentech in the Journal of Pharmaceutical Sciences. The study demonstrated that conjugating PROTAC molecules to Starpharma’s DEP® dendrimer platform enhanced tumour exposure and improved tolerability in a non-small cell lung cancer model, underscoring the platform’s versatility across emerging therapeutic modalities.
The company’s strategic presence at major industry events such as JP Morgan and BIO-Europe further showcased its Star Navigator program, designed to accelerate partner engagement and streamline access to dendrimer drug conjugates. These efforts build on previous significant deals, including upfront payments and milestone arrangements with Genentech, which have underpinned Starpharma’s recent financial turnaround and pipeline advancement.
Commercial Growth Supported by Viraleze™ and VivaGel® BV
On the commercial front, Starpharma reported a robust ~65% year-to-date increase in web sales of Viraleze™, reflecting growing market traction. The company continues to support its global partners for Viraleze™ and VivaGel® BV, with particular interest in expanding VivaGel® BV’s footprint in Europe. These consumer health products contribute to Starpharma’s diversified revenue streams and complement its clinical-stage pipeline.
Financial Position and Operating Cashflows
Starpharma ended the quarter with a cash balance of $14.1 million, after net operating cash outflows of $3.9 million. Year-to-date, the company has achieved a break-even cash position, reflecting disciplined expenditure on research and development ($2.0 million for the quarter) and staffing costs ($2.1 million). The company anticipates reduced cash outflows in the final quarter of FY26 and expects to receive an R&D tax incentive payment early in FY27, providing additional runway for its clinical programs and business development activities.
Notably, operating receipts for the quarter included $0.9 million from R&D project income and product sales, underscoring Starpharma’s balanced focus on advancing its internal pipeline and commercial operations. The company also maintains modest financing facilities secured against leased laboratory equipment, supporting operational flexibility.
Investor Engagement Highlights Strategic Value Creation
CEO Cheryl Maley’s presentation at the Ignite Investment Summit in Hong Kong highlighted Starpharma’s clinically validated DEP® platform and its multiple avenues for value creation, including the Star Navigator incubator model and internal radiopharmaceutical programs. Maley emphasized the growing global cancer burden and the differentiated potential of dendrimer technology to address unmet needs, reinforcing investor confidence in Starpharma’s strategic direction.
This update builds on the company’s earlier FDA supports DEP® HER2 phase 1 study design and its major upfront payment from Genentech that have underpinned recent clinical and commercial progress.
Bottom Line?
Starpharma’s FDA alignment for DEP® HER2 and ongoing partnership validation set a clear clinical development path, but sustaining cash flow and converting partner interest into deals will be key to maintaining momentum.
Questions in the middle?
- Will Starpharma secure IND approval and commence DEP® HER2 trials on schedule in H2 2026?
- How will the company leverage published Genentech data to attract new partnerships or licensing deals?
- Can rising Viraleze™ sales and partner conversions offset ongoing R&D cash outflows in FY27?