Viraleze (astodrimer intranasal) / Starpharma - LARVOL DELTA

Astodrimer Sodium Nasal Spray versus Placebo in Non-Hospitalised Patients with COVID-19: A Randomised, Double-Blinded, Placebo-Controlled Trial. (PubMed, Pharmaceutics) - "Astodrimer nasal spray reduces viral burden and accelerates viral clearance, especially in older populations, and is well tolerated."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Starpharma Receives $5.5M R&D Tax Incentive Refund (Starpharma Press Release) - "Starpharma...today announces that it has received a $5.5M Research and Development (R&D) Tax Incentive refund for the 2024 financial year. The refund is associated with eligible R&D activities across Starpharma’s portfolio, including the company’s DEP drug delivery programs and VIRALEZE....The Australian Government's R&D Tax Incentive program provides a refundable tax offset to companies such as Starpharma that are undertaking eligible R&D activities. This initiative aims to encourage investment in R&D, fuelling innovation and ultimately boosting Australia's global competitiveness, driving economic growth and creating job opportunities."

Financing • Breast Cancer • Castration-Resistant Prostate Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • Infectious Disease • Metastatic Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Astodrimer sodium nasal spray forms a barrier to SARS-CoV-2 in vitro and preserves normal mucociliary function in human nasal epithelium. (PubMed, Sci Rep) - "Carr-NS, HPMC-NS, NO-NS and PI-NS demonstrated limited antiviral effects, while HPMC-NS caused inhibition of mucociliary function. Astodrimer sodium nasal spray demonstrates an acceptable nonclinical efficacy and safety profile as a barrier nasal spray against respiratory viral infection in the nasal cavity."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Otorhinolaryngology • Respiratory Diseases

Quarterly Activities Report & Appendix 4C (ASX Announcement) (Starpharma Press Release) - "In the May 2024 business update, Starpharma announced plans to advance its DEP HER2 radiodiagnostic candidate towards a first-in-human clinical study in 2025. Additionally, the Company presented a scientific poster at the SNMMI Annual Meeting in Toronto, Canada, in June 2024, highlighting the promising utility of dendrimers in precision radiotheranostics for cancer imaging and therapeutic applications....Net operating cash outflows for Q4 FY24 were $3.0 million, including research and development (R&D) costs of $1.8 million. As expected, the June quarter outflows decreased from Q3, which had R&D costs of $3.3 million. The Q3 costs included clinical trial close-out expenses associated with the completion of the DEP cabazitaxel, DEP docetaxel, and Viraleze clinical programs."

Commercial • New trial • Oncology • Solid Tumor

Half Yearly Report and Accounts (ASX Announcement) (Starpharma Press Release) - "Starpharma...releases its Interim Report and Half-Year Financial Results for the period ended 31 December 2023 (H1 FY24)....The half-year loss after tax was $1.0M (H1 FY23: $8.3M) and includes research and product development expenses of $5.3M (H1 FY23: $5.6M) net of the Australian Government’s R&D tax incentive. Research expenditures were primarily associated with Starpharma’s internal DEP drug delivery programs, including DEP docetaxel, DEP cabazitaxel, DEP irinotecan, DEP ADCs and DEP radiotheranostics, and the Viraleze post-market study."

Commercial • Breast Cancer • Gastrointestinal Cancer • Infectious Disease • Oncology • Pancreatic Cancer • Solid Tumor

"Viraleze isn’t carrageenan It’s nano tech Astodrimer sodium and brilliant 99.9% effective" (@CharmsYahoo)

"@Starpharma_ASX any updates on this? @TGAgovau any updates on Viraleze approval for Australia? @Mark_Butler_MP any progress on this approval ?" (@Randall87454048)

"@TGAgovau and @Starpharma_ASX can you clarify why Viraleze is unavailable in Australia? What is the reason for this refusal?" (@Randall87454048)

"FYI - you can get Enovid via https://t.co/DHs2dcndTe, use coupon 'ref9029535' for $50 off first order. Ships internal for free and is quick. Norizite is cheaper, as is Viraleze. They all work in slightly different ways." (@Spoopledooper)

"#wtfTGA @TGAgovau Approve Viraleze like European regulators did in November 2020 - the authority in Nanoparticles as legislated in Australia 2022" (@CharmsYahoo)

"Where is my Viraleze nasal spray @TGAgovau" (@MauriceCousins1)

"@AlanBixter here is what Australian employers and hospitals could do. @TGAgovau could be proactive in approving nasal sprays such as @Starpharma_ASX VIRALEZE" (@CharmsYahoo)

Clinical

"Strangely, cannot get in the U.S. but can order Sanotize NO2 spray....which has gotten prohibitively expensive. Wanting viraleze since it's a mere 15 euros." (@EqualityNow2112)

"@Mark_Butler_MP Can you please fast track access to Viraleze? @TGAgovau" (@bees_oz)

"Viraleze" (@ChrisBidgood)

"Just hurry up and approve - Viraleze" (@adamscoote)

"Should be national recall until correct labelling instructions completely amended - plus approve Viraleze whilst there" (@adamscoote)

"And TGA needs to approve Viraleze quickly like 30+ countries - why are we waiting @AlboMP @Mark_Butler_MP @TGAgovau" (@CharmsYahoo)

"Agreed. Why has the TGA deemed viraleze 'a medical device' for approval? The antiviral - SPL7013 is already approved for treatment of bacterial vaginosis." (@Agarwoodgreen)

Vaginitis

"Doctors should be asking WHY NO VIRALEZE nanotech AV Nasal Spray" (@CharmsYahoo)

"Look at effectiveness of Viraleze - why are we waiting" (@CharmsYahoo)

"@EurekaJustice @RichmdSewerRat @CrabbBrendan @DrMukeshH @JasonClareMP @DanielAndrewsMP @VictorianCHO In April22 TGA FINALLY decided to consider @Starpharma_ASX VIRALEZE which is 99% effective anti-viral covid incl Omicron as a MEDICAL DEVICE - @TGAgovau why are we waiting?" (@CharmsYahoo)

Novel Coronavirus Disease

"Yes, TGA has dragged it's feet for waaay to long on approving Viraleze." (@gl34220379)

"Eric - how are you NOT aware of Viraleze AntiViral Spray?" (@BourbonShandy)

"What do we want - Viraleze. When do we want it - NOW! please" (@ChrisBidgood)