On July 29, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its Quarterly Activities Report and Appendix 4C for the period ended 30 June 2022 (Press release, Starpharma, JUL 29, 2022, View Source;mc_eid=bf52dd3418 [SID1234617144])
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Starpharma’s closing cash balance as at 30 June 2022 was $49.9 million. The net cash burn for the financial year was $10.6 million. Receipts from customers and grants for FY22 totaled $13.0 million, including receipts from customers of $4.8 million (FY21: $2.4 million).
Commenting on the quarter, Dr Jackie Fairley, Starpharma CEO, said:
"Starpharma continues to attract and deepen our partnerships with industry leading pharma companies, reaffirming the broad applicability of our DEP technology which has the potential to be applied to a vast number of therapeutic products under multiple, independent commercial agreements. During the quarter, existing DEP partner AstraZeneca, expanded the clinical program for their DEP product, AZD0466. This expanded program includes an additional indication (non-Hodgkin’s lymphoma) as well as a significant increase in the number of recruitment sites globally to accelerate patient enrolment in the planned expansion phase of the ongoing leukemia trial. In parallel, our three clinical stage DEP products and our preclinical candidates have continued to make good progress.
"Marking an important milestone, VIRALEZE was relaunched this quarter in the UK through our commercial partner, LloydsPharmacy, with promotional activities underway. We were delighted to also report new results from our collaboration with The Scripps Research Institute, demonstrating the highly protective effects of VIRALEZE against the Omicron variant of SARS-CoV-2 in an in vivo viral challenge model. Importantly, these findings showed that VIRALEZE could provide significant benefit when used either before and after exposure to virus, or when used only after exposure to virus. VIRALEZE is now registered in over 30 countries and available in pharmacies, retail outlets and online."
Partnered DEP Programs
Starpharma recently signed an expanded DEP Research Agreement with Genentech. During the quarter, Starpharma has commenced work on this new program, which involves the design and synthesis of DEP dendrimer conjugates incorporating a Genentech proprietary molecule.
Under Starpharma’s DEP licence with AstraZeneca, the international clinical program for AZD0466 continued to advance with multiple new sites opening and commencement of a new clinical trial in an additional indication – non-Hodgkin’s lymphoma (NHL), one of the most commonly occurring cancers. The new NHL Phase 1/2 trial of AZD0466 is now recruiting at sites in the US and Korea. AstraZeneca plans to further expand recruitment for this trial, with more than 20 additional sites expected to open across the US, Canada, Europe, Australia, and Asia.
In the Phase 1/2 leukemia trial of AZD0466 in patients with advanced haematological malignancies additional sites were also opened. This trial is now recruiting at sites in the US, Australia, Italy, Germany, and Korea.
A further new DEP agreement with a leading pharmaceutical company is well advanced. Active commercial discussions continue in other areas including DEP radiopharmaceuticals.
Internal DEP Programs
Starpharma’s Phase 2 clinical trial of DEP cabazitaxel continues to recruit well with 68 patients enrolled to date, including a number of advanced refractory ovarian cancer and gastro-oesophageal cancer patients. Patients in this trial continue to show encouraging efficacy signals, including prolonged stable disease, significant tumour shrinkage, and reductions in tumour markers.
DEP cabazitaxel has been selected for a poster presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in early September. The poster will focus on a summary of the clinical data on DEP cabazitaxel in prostate cancer. ESMO (Free ESMO Whitepaper) is considered one of the largest international oncology conferences and is attended by clinicians, researchers, and healthcare industry representatives from all over the world, representing an excellent platform for presenting these results.
The DEP irinotecan Phase 2 clinical trial continues to progress well, with 82 patients now enrolled. Efficacy signals such as prolonged tumour shrinkage and reductions in tumour markers have been observed in multiple tumour types, including colorectal, breast, ovarian, pancreatic, lung, and oesophageal cancers. Starpharma is finalising preparations for the commencement of a combination arm for DEP irinotecan in combination with 5-FU + Leucovorin (‘FOLFIRI’, a commonly used combination treatment regimen in colorectal cancer) to run in parallel with the ongoing monotherapy study. The combination arm is expected to commence shortly at sites in the UK and Australia.
The clinical program for DEP docetaxel has enrolled 71 patients across the monotherapy and combination arms, with additional patients in screening. Encouraging efficacy signals such as prolonged stable disease and significant tumour shrinkage have been observed in heavily pre-treated patients with lung, pancreatic, oesophageal, cholangiocarcinoma and gastric cancers.
Manufacture of DEP gemcitabine product is now complete in readiness for Starpharma to commence a Phase 1/2 clinical trial, with planned clinical trial sites in the UK and Australia. Preparations for trial commencement are well advanced, with the clinical research organisation (CRO) and site selection processes, regulatory and ethics preparations nearing completion.
In parallel with progressing these clinical candidates, Starpharma continues to undertake discussions with potential licensing partners. Starpharma continues to deepen its pipeline of DEP assets by actively progressing a number of its own internal programs in areas including DEP radiotheranostics and DEP antibody drug conjugates (ADCs).
Marketed Products
During the quarter, VIRALEZE nasal spray was relaunched in the UK through LloydsPharmacy, with a number of promotional activities underway. LloydsPharmacy is one of the largest pharmacy groups in the UK with ~1400 stores, and its affiliated wholesale arm AAH, is also one of the largest pharmaceutical wholesalers in the UK, supplying over 14,000 independent pharmacies.
VIRALEZE recently demonstrated excellent protection against infection with the highly transmissible SARS-CoV-2 Omicron variant in a stringent in vivo viral challenge model. The findings are important because they indicate, even when VIRALEZE is only used after exposure to virus (e.g., if you forget to use the spray before exposure to a high-risk situation), it has potential to provide significant benefit.
The broad-spectrum activity of VIRALEZE was further highlighted with impressive results for SPL7013, in VIRALEZE, against influenza A and B. SPL7013 achieved more than 90% reduction in viral infectivity of both influenza A and B viruses within one minute. These influenza viruses are responsible for seasonal epidemics of influenza, with influenza A being known to cause flu pandemics. SPL7013 also demonstrated irreversible virucidal properties against both types of influenza virus. In addition, testing at Scripps Research assessed the activity of two antiviral agents used in marketed nasal sprays – hydroxypropyl methyl cellulose (HPMC) and iota-carrageenan. In contrast to the potent and rapid effect of SPL7013, seen within one minute, HPMC and iota-carrageenan did not exhibit virucidal effect in this experiment, even after 30 minutes.
VIRALEZE is registered in more than 30 countries and is available in pharmacies, retail outlets and online in a number of countries. Starpharma continues to pursue registration and commercialisation for VIRALEZE in multiple other countries, with active commercial discussions underway. In Australia, the review by the TGA for the nasal spray application as a medical device is ongoing.
Regulatory approvals for VivaGel BV were achieved in Bahrain and Qatar and pre-launch marketing activities have commenced. Starpharma’s marketing partner, Mundipharma is also progressing further launches of VivaGel BV in Asia as well as undertaking joint regulatory activities across a number of countries.
Other Business Development Activities
In an endorsement of interest in Starpharma’s DEP technology, the company was invited to present DEP at the Novel Format Conjugates Summit, an industry conference focusing on next generation non-traditional ADCs, which took place in Boston in April. The conference participants included senior representatives from AstraZeneca, Merck, and Sanofi. An abridged version of Starpharma’s presentation is available on our website.
During the quarter, Starpharma also participated in major industry conferences, including American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and BIO International. The company also met with a number of existing DEP partners and potential new partners during these meetings.
Cash Flows
Starpharma’s closing cash balance as at 30 June 2022 was $49.9 million. Receipts from customers and grants for FY22 totaled $13.0 million, including receipts from customers of $4.8 million (FY21: $2.4 million) and total grants of $8.2 million, including $7.7 million R&D tax incentive.
During the quarter, Starpharma continued to invest in research and development (R&D) for its three clinical stage DEP programs as well as a number of preclinical programs, including in DEP antibody drug conjugates and DEP radiotheranostics. Net operating cash outflows for the quarter were $4.9 million, including R&D outflows of $2.2 million and product manufacturing and operating costs of $1.2 million for VIRALEZE, VivaGel BV and key raw material inventory. Staffing costs of $2.0 million include non-executive and executive directors’ fees of $258,000. Other related party transactions required for disclosure were $3,479 for consulting services.