Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-14

Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

“This quarter has been a very important period for advancing the core programs that we anticipate will deliver the greatest value using our unique, clinically validated dendrimer technology. Our team remains highly focused on delivering meaningful results through these programs. We are making significant progress in each of our three strategic priorities outlined in May: maximising DEP® asset value, accelerating early asset development, and building long-term sustainability. We are closely monitoring all programs to ensure efficiency and optimal outcomes along with long-term value creation. We understand that some key results are highly anticipated, and we are working diligently to achieve these milestones in a timely manner. We look forward to sharing further updates and engaging with shareholders at the AGM in November.”


In addition to our existing collaborations with Petalion, Genentech, and MSD, we are actively engaged with several companies interested in applying our dendrimer technology to enhance their product pipelines.


DEP® radiopharmaceuticals program advancing towards a clinical study Starpharma has made good progress this quarter in its DEP® radiopharmaceuticals program, both internally and with potential collaborators in this space. We are advancing the development of a DEP® HER2 radiodiagnostic candidate with the goal of advancing a lead candidate that is well-positioned to bring significant value for patients and provide a competitive advantage in the HER2 diagnostic market. In addition, we have actively sought input from KOLs and started discussions with potential clinical sites and contract research organisations (CROs) to ensure we can commence the first-in-patient clinical trial as efficiently as possible. Notably, the early-stage data we have generated and presented at conferences in recent months has sparked significant interest in collaborations from a range of companies in the radiopharmaceuticals sector.

We will also be meeting with regulators in the coming months to discuss these indication-specific clinical development pathways

the above refers to the 505(b)(2) pathway

The 505(b)(2) pathway is a streamlined process for the United States Food and Drug Administration (FDA) to approve new drugs:

• What it is
  A section of the Federal Food, Drug, and Cosmetic Act, the 505(b)(2) pathway allows the FDA to use existing data to approve new drugs.
  
  
• When to use it
  This pathway is ideal for new combinations, modified versions of approved drugs, or new indications.
  
  
• Benefits
  The 505(b)(2) pathway can result in faster development, lower risk, reduced costs, and potential market exclusivity.
  
  
• How it works
  The 505(b)(2) pathway allows the FDA to rely on data not developed by the applicant, such as safety and effectiveness reports. The applicant must demonstrate that the proposed drug is scientifically justified in relation to a previously approved drug.
  
  
• Challenges
  The 505(b)(2) pathway can be challenging because the applicant must demonstrate a scientific justification for the bridge between the proposed drug and the previously approved drug.
  
  
• Success factors
  Success in the 505(b)(2) pathway requires a robust bridging strategy, early commercialization planning, and a thorough literature review.
  
  

The European equivalent of the 505(b)(2) pathway is the Hybrid application.