DEP cabazitaxel (CTX-SPL9111) / Starpharma - LARVOL DELTA

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

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

Efficacy and safety of dendrimer-enhanced (DEP) cabazitaxel (DEP CTX) in patients with advanced solid cancers in a phase 1/2 trial (P1/2). (ASCO 2024) - P1/2 | "DEP CTX exhibited clinically meaningful, durable antitumor activity in multiple advanced solid cancers, including mCRPC, Pt-R OV and EG cancers without the need for steroid premedication. The antitumor activity & safety results compare favorably to s-CTX, or standard of care chemotherapy in non-prostate cancers, and highlight the promising potential of dendrimer-enhanced delivery of cabazitaxel."

Clinical • Metastases • P1/2 data • Anemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fatigue • Gastrointestinal Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Neutropenia • Oncology • Ovarian Cancer • Pain • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Thrombocytopenia

Quarterly Activities Report & Appendix 4C (ASX Announcement) (Starpharma Press Release) - "Starpharma’s Phase 1/2 clinical data for DEP cabazitaxel and DEP irinotecan have both been accepted for oral presentations at the ASCO Annual Meeting, which will take place in Chicago, US, from 31 May to 4 June 2024...Starpharma’s Phase 2 clinical trial of DEP irinotecan as monotherapy and in combination with 5-fluorouracil (5FU) and leucovorin (LV) is nearing database lock. Preparations for analysis of the full data are well underway, with the data to be released ahead of and presented at the ASCO meeting in early June...Starpharma will present data from its internally developed DEP HER2 radiotheranostic program at the upcoming SNMMI Annual Meeting, which will be held from 8 to 11 June in Toronto, Canada....This quarter’s R&D costs included clinical trial close-out costs of $1.6 million related to the completion of the DEP cabazitaxel, DEP docetaxel..."

Clinical data • Commercial • 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

Efficacy and safety of dendrimer-enhanced (DEP) cabazitaxel (CTX-SPL9111) in advanced esophagogastric cancers in a phase 1/2 trial. (ASCO-GI 2024) - P1/2 | "DEP cabazitaxel exhibited highly encouraging anti-tumor activity in >1L, advanced EGC in multiple anatomic locations and of different histological sub-types. The preliminary efficacy and safety results compare favorably to available treatment options and highlight the promising clinical potential of DEP cabazitaxel in advanced EGC. Clinical trial information: EudraCT 2017-003424-76."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Efficacy and safety of dendrimer-enhanced (DEP) cabazitaxel (CTX-SPL9111) in men with metastatic castration-resistant prostate cancer (mCRPC) in a phase I/II trial (ESMO 2022) - P1/2 | "No steroid pre-medication was required. We report encouraging anti-tumour activity in heavily pre-treated mCRPC pts."

Clinical • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Starpharma presents compelling data in Prostate Cancer at ESMO (PRNewswire) - P1/2 | N=25 | "In a poster presentation at ESMO...exciting new data on the superior efficacy and lower incidence of key side effects in mCRPC patients was presented. DEP® cabazitaxel showed multiple potential benefits for patients with mCRPC, including: A >30% improvement in median progression free survival (PFS; time a patient lives without disease progression following treatment) compared to standard cabazitaxel - 3.9 months v 2.9 months respectively. 100% of evaluable DEP® cabazitaxel patients achieved a response in at least 1 measure of efficacy (soft tissue disease, prostate specific antigen and/or bone disease)."

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Starpharma releases positive DEP phase 2 interim results in prostate cancer (PRNewswire) - P1/2, N=51; “Responses included: 64% of patients with assessable tumour lesions saw prolonged stable disease and significant reductions in tumour size for up to 36 weeks. 90% of patients with assessable PSA (Prostate Specific Antigen) tumour biomarker levels had a reduction in PSA, with more than half of these patients achieving a reduction in PSA of at least 50%. 83% of patients with secondary bone disease exhibited either no progression or an improvement in these lesions. 56% of patients who were evaluable for all three measures had responses to all three. These positive interim results are particularly significant given all patients in this cohort had late-stage prostate cancer and had failed multiple anti-cancer treatments (including taxanes), in addition to surgeries and radiation, prior to entering the DEP® cabazitaxel trial....Full results for the trial will be reported separately in the coming months.”

P2 data • GastroEsophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer

US Patent and Trademark Office grants new patent for DEP cabazitaxel, one of Starpharma's phase 2 clinical-stage cancer treatments (PRNewswire-Asia) - "DEP® cabazitaxel is a proprietary nanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana®), which had global sales of US$536 million in 2020. Starpharma's DEP® cabazitaxel is a water soluble, polysorbate-80 free formulation, without requirement for pre-treatment with steroids nor G-CSF to reduce the risk of severe bone marrow toxicity....The composition of matter patent builds on Starpharma's suite of existing international patents for DEP® cabazitaxel. It specifically covers a DEP® dendrimer conjugated to multiple cabazitaxel drug molecules via a particular releasable linker, with a patent term to 2039 and potential for a 5-year extension....DEP® cabazitaxel is in late phase 2 clinical development, recruiting patients with solid tissue tumours, including prostate, ovarian and gastro-oesophageal cancers."

Patent • Esophageal Cancer • Gastric Cancer • GastroEsophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Prostate Cancer • Urothelial Cancer