Aug 24, 2023
Starpharma annual report and full-year financial results (ASX Announcement)
Melbourne, Australia; 24 August 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) today releases its annual report and full-year financial results for the year ended 30 June 2023.
- Strong balance sheet with cash of $35.2 million at 30 June 2023. This excludes A$6.6M received from Mundipharma in August 2023, following the recent commercial settlement for VivaGel® BV.
- Reported loss down 3% to $15.6M (FY22: $16.2M).
- Revenue down 14% to $4.2M (FY22: $4.9M).
- Starpharma received a $7.1 million R&D tax incentive refund in December 2022, with an anticipated R&D tax incentive refund of $7.6 million expected in FY24.
- Expanded partnerships with multinational pharmaceutical companies MSD and Genentech, exploring the application of DEP® across several novel therapeutic modalities, including Antibody-Drug Conjugates (ADCs).
- Generated additional clinical data across our three clinical DEP® programs, including promising data for DEP® cabazitaxel in patients with advanced prostate cancer, which were presented at the European Society of Medical Oncology (ESMO) Congress in Paris.
- Completed recruitment of patients for all three in-house Phase 2 monotherapy clinical programs: DEP® cabazitaxel, DEP® docetaxel, and DEP® irinotecan.
- Launched VIRALEZE™ Antiviral Nasal Spray in Hong Kong and Macau through our partner Hengan Group, shortly after signing a new distribution agreement for these markets.
- Commenced a post-market clinical study of VIRALEZE™ in patients with COVID-19 in the UK. The study has recruited ahead of target with more than 90% of the target participants now enrolled.
- Advanced two new DEP® pipeline products which demonstrated the unique benefits of the DEP® platform in radiotheranostics and ADCs:
- DEP® HER2-zirconium, a radiodiagnostic for HER2-positive cancers, such as breast cancer and gastric cancer; and
- HER2-targeted DEP® SN38 ADC, a targeted ADC therapeutic, which outperformed leading ADC therapy Enhertu® in a HER2+ human ovarian cancer model.
Dr Jackie Fairley, Starpharma CEO, commented, “Starpharma made significant progress across its portfolio during the 2023 financial year. Across our three Phase 2 DEP® clinical programs, which have now completed recruitment in the monotherapy arms, we have seen encouraging efficacy signals and reductions in multiple clinically important side effects, compared to adverse events for conventional formulations of these drugs. Our trial clinicians continue to report improved patient experiences with DEP® therapies. We were pleased to present data from the prostate cancer cohort of the DEP® cabazitaxel trial at ESMO and look forward to releasing and presenting more data from our Phase 2 trials in Q3 CY23.
“We were delighted to expand our DEP® partnerships with leading, global companies, MSD and Genentech, adding new programs of work, which are progressing well. Our antiviral nasal spray, VIRALEZE™, was launched in Hong Kong and Macau, and new product registrations were achieved in Indonesia and Malaysia with further applications underway. Our post-market clinical study of VIRALEZE™ in people with COVID-19 is recruiting ahead of schedule, with more than 90% of participants enrolled and data expected soon after completion.
“Starpharma remains in a very strong financial position, with cash reserves of $35.2 million at 30 June 2023, and the subsequent receipt of A$6.6M in August 2023, from Mundipharma, following the signing of a settlement agreement related to VivaGel® BV.
“Looking ahead, we have a number of exciting milestones, including results from our DEP® oncology trials, multiple upcoming presentations at international oncology and radiotheranostics meetings, as well as results from our post-market VIRALEZE™ study. We also expect advances in our partner and preclinical DEP® programs, as well as for VIRALEZE™ and VivaGel® BV."
DEP® Drug Delivery Programs
Starpharma’s Phase 2 clinical trial of DEP® cabazitaxel completed the enrolment and treatment of patients, with 76 participants enrolled. Encouraging efficacy signals following treatment with DEP® cabazitaxel have been observed, including significant tumour shrinkage and tumour biomarker reductions, in heavily pre-treated patients with advanced cancers, including prostate, ovarian, gastrooesophageal, cholangiocarcinoma and head and neck cancer. In September 2022, Starpharma presented promising results from the prostate cancer cohort at the European Society of Medical Oncology (ESMO) Congress. Starpharma expects to report the Phase 2 results from this trial in Q3 CY23, with partnering discussions ongoing.
The Phase 2 monotherapy arm of the DEP® docetaxel trial also completed enrolment and treatment of patients. 50 patients were recruited and treated with DEP® docetaxel in the monotherapy arm, and encouraging efficacy signals, including prolonged stable disease and significant tumour shrinkage, have been observed in heavily pre-treated patients with multiple cancer types, including pancreatic cancer, gastro-oesophageal cancer, and cholangiocarcinoma. Starpharma expects to report the Phase 2 results from this trial in Q3 CY23, with partnering discussions ongoing.
Starpharma also completed patient enrolment in the monotherapy arm of the Phase 2 clinical trial of DEP® irinotecan, with 88 patients having been enrolled in the monotherapy arm. Encouraging results have been seen in patients with multiple cancer types, including colorectal, platinum-resistant ovarian, gastrointestinal, and breast cancer, with durable responses for up to 72 weeks. Starpharma also progressed the combination arms of the DEP® irinotecan (5-FU/leucovorin) and DEP® docetaxel (gemcitabine) Phase 2 trials, with final patient recruitment underway. The irinotecan plus 5-FU/leucovorin combination is a standard-of-care treatment regimen for colorectal cancer.
In parallel with completing these Phase 2 programs, Starpharma continued to build its pipeline of DEP® assets, advancing the development of two promising products in DEP® radiotheranostics and DEP® ADCs. In June 2023, Starpharma announced that DEP® HER2-zirconium, a HER2-targeted radiodiagnostic, demonstrated imaging benefits in a HER2+ breast cancer model. The demonstrated benefits included a favourable biodistribution profile, excellent imaging contrast between tumour and normal tissues, rapid uptake, and high levels of tumour accumulation. In addition, Starpharma announced the development of a HER2-targeted DEP® SN38 ADC, which demonstrated significant anti-tumour activity and improved survival in a HER2-positive (HER2+) human ovarian cancer xenograft model, outperforming a leading HER2-ADC, Enhertu®.
Starpharma’s partners include some of the world's largest pharmaceutical companies, such as MSD, Genentech, Chase Sun and AstraZeneca. During the financial year, Starpharma expanded its DEP® programs with MSD and Genentech to include new programs of work. Starpharma’s partnered programs apply the Company’s DEP® platform technology to several novel therapeutic modalities, including Antibody-Drug Conjugates. In late July 2023, AstraZeneca announced it had made the decision to discontinue the development of AZD0466, following an internal review of its haematology portfolio. AstraZeneca confirmed that the asymptomatic adverse events leading to this decision were not related to the dendrimer component of AZD0466. Starpharma’s DEP® License Agreement with AstraZeneca remains in effect. Starpharma maintains an active business development program for the DEP® platform, with commercial discussions underway in a number of areas, including DEP® radiotheranostics and DEP® ADCs. The recently released positive data in both these areas feed into these discussions and will be showcased at upcoming international conferences.
VIRALEZE™ Antiviral Nasal Spray
During the financial year, Starpharma’s antiviral nasal spray, VIRALEZE™, was launched in new markets, including Hong Kong and Macau, through an extensive network of retail stores, online, and other channels. The launch followed the signing of a sales and distribution agreement with Hengan Group and was supported by marketing activities. Hengan is based in China, listed on the Hong Kong Stock Exchange, has an annual turnover of ~A$4.5 billion and employs ~23,000 staff.
Marketing of VIRALEZE™ continued in multiple jurisdictions, including Hong Kong, Macau, Vietnam, the UK, and Europe. During the year, Starpharma expanded its e-commerce channels in the UK, making VIRALEZE™ available through a dedicated product website and Amazon UK. This year, Starpharma achieved registration for VIRALEZE™ in Malaysia and Indonesia, bringing the number of countries where VIRALEZE™ is registered to more than 35, and submitted regulatory applications in other jurisdictions. VIRALEZE™ is not approved for use or supply in Australia. The review by the Therapeutic Goods Agency (TGA) for the SPL7013 nasal spray as a medical device is ongoing.
Starpharma commenced a post-market clinical study of VIRALEZE™ in the UK in December 2022. The study will provide valuable clinical data on the antiviral performance of VIRALEZE™ in COVID-19-positive individuals. The study has recruited ahead of schedule, with more than 90% of participants enrolled to date. Starpharma presented new data on the efficacy of VIRALEZE™ against SARS-CoV-2 omicron infection in an animal challenge model at the international virology conference Respi DART in December 2022. These data, which were generated at Scripps Research in the US, showed that VIRALEZE™ was able to eliminate the SARS-CoV-2 omicron virus by more than 99.99% in the lung and trachea of animals that were exposed to the virus, even when VIRALEZE™ was administered after exposure.
Starpharma’s VivaGel® BV product continued to be marketed in multiple jurisdictions, including by Starpharma’s partner Aspen in Australia and New Zealand. Marketing campaigns by partners to build brand awareness and sales are ongoing, including for consumer and professional healthcare audiences. In August 2023, Starpharma announced it had negotiated a commercial settlement agreement with Mundipharma for VivaGel® BV, which included a A$6.6M cash payment to Starpharma. Under the agreement, Starpharma also regained all commercial rights to VivaGel® BV, enabling Starpharma to appoint new marketing partners, with commercial interest already expressed in the product. In the US, a formal dispute resolution process is ongoing with the Food and Drug Administration (FDA) for VivaGel® BV. As part of this process, Starpharma has received extensive external advice, met the FDA
on multiple occasions, and made a number of submissions of data and analyses to the regulator. The Company is preparing to lodge a further submission to the FDA, including precedents of other FDA approvals, with the timing of lodgement governed by the publication and incorporation of relevant precedent information.
Starpharma’s VivaGel® Condom continues to be marketed by Okamoto in Japan, with Okamoto also pursuing approvals in other Asian countries.
Ms Zita Peach retired from the Board in November 2022 after 11 years. In February 2023, Starpharma welcomed medical oncologist and former senior executive Dr Russell Basser to the Board. Dr Basser has substantial expertise in international drug and vaccine development, having held multiple senior executive roles at CSL. In April 2023, Mr Justin Cahill joined Starpharma as Chief Financial Officer (CFO) and Company Secretary. Mr Cahill has extensive corporate finance and leadership experience in the biopharmaceutical, food, and agricultural sectors with several private and ASX-listed companies, including CSL. In February 2023, Starpharma appointed Ms Tracy Weimar as interim Company Secretary.
In June 2023, Dr Jackie Fairley advised the Board of her intention to retire as CEO in 2024 after 17 years. A search process is underway and Dr Fairley, the Board, and the senior executive team are working closely to ensure a seamless transition.
Starpharma concluded FY23 in a strong financial position with a cash balance of $35.2 million. Net operating cash outflows for the year were $13.5 million (FY22: $13.2 million). This excludes A$6.6M received from Mundipharma in August 2023 following the recent commercial settlement for VivaGel® BV.
Revenue for FY23 was $4.2 million (FY22: $4.9 million), which included $2.9 million from VIRALEZE™ and VivaGel® product sales, royalties, licensing revenue, and research revenue from commercial partners, as well as interest income of $1.3 million.
The FY23 loss after tax continued to trend downwards to $15.6 million (FY22: $16.2 million). Expenditure included investment in research and product development associated with the internal DEP® drug delivery programs, including Starpharma’s clinical-stage products, DEP® cabazitaxel, DEP® docetaxel, DEP® irinotecan, which have now largely completed recruitment, as well as DEP® ADCs, and DEP® radiotheranostics, and the post-market clinical study of VIRALEZE™.
Starpharma received a $7.1 million R&D tax incentive refund in December 2022, with an anticipated R&D tax incentive refund of $7.6 million expected in FY24.
View or download the ASX Announcement here.