Aug 25, 2022
Starpharma annual report and full year financial results
Melbourne, Australia; 25 August 2022: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its annual report and financial results for the year ended 30 June 2022.
Download Annual Report 2022.
Financial Results
- Strong cash position with a balance of $49.9M as at 30 June 2022
- Revenue up 128% to $4.9M (FY21: $2.2M) on the rollout of VIRALEZE™
- Reported loss down 18% to $16.2M (FY21: $19.7M)
- Receipt of $7.7M R&D tax incentive
Highlights
- Two new DEP® partnerships with leading, global pharmaceutical companies, Genentech and Merck & Co., Inc.
- Sales of VIRALEZE™ have significantly increased in FY22, following new product launches in Vietnam and Italy and relaunch in the UK by LloydsPharmacy
- Positive interim efficacy findings reported in the prostate cancer cohort of the Phase 2 DEP® cabazitaxel trial showing efficacy signals in 100% of evaluable patients
- Three clinical-stage internal DEP® oncology assets advancing well, with encouraging efficacy signals observed
- AstraZeneca’s partnered DEP® product, AZD0466: additional indication (non-Hodgkin’s lymphoma) added and recruitment initiated in a global Phase 1/2 clinical trial; additional trial sites opened for the initial Phase 1/2 leukemia trial
- VIRALEZE™ demonstrated high levels of protection against Omicron in an in vivo challenge model as well as impressive antiviral effects against influenza in laboratory studies and outperformed other antiviral agents used in marketed nasal sprays
Starpharma CEO, Dr Jackie Fairley, commented on the full year results:
“Starpharma has achieved many significant milestones across our business during FY22, including significant increases in revenue and the execution of new and valuable corporate partnerships, despite the ongoing challenges presented by the global pandemic.
“Starpharma was very pleased to sign two new DEP® partnerships with leading, global companies – Genentech and Merck & Co., Inc – while our most advanced partner, AstraZeneca, further expanded the global clinical program for their DEP® product, AZD0466, adding a new cancer type (non-Hodgkin’s lymphoma) and significantly increasing the number of trial sites worldwide. These new AZD0466 developments are particularly exciting for Starpharma, given the expanded market potential, and together with our new DEP® partnerships, signify the growing momentum and value in our DEP® platform.
“During the year, Starpharma’s internal DEP® products continued to yield impressive responses in our Phase 2 oncology trials, including significant tumour shrinkage and stable disease in some of the most common and deadly cancers. We were pleased to report the positive interim findings from the prostate cancer cohort of Starpharma’s DEP® cabazitaxel trial in which efficacy signals were observed in all evaluable patients treated with our DEP® version of the leading prostate cancer drug cabazitaxel.
“Starpharma’s marketed products have reached more people this year than ever before, with sales of VIRALEZE™ significantly increasing following successful product launches in Vietnam and Italy, and relaunch in the UK through LloydsPharmacy. In parallel with commercial activities for VIRALEZE™, we have continued to test the efficacy of SPL7013, the antiviral agent in VIRALEZE™, against important respiratory viruses, including multiple variants of SARS-CoV-2 and influenza. SPL7013 has demonstrated consistent potent activity against a broad spectrum of respiratory viruses and has outperformed other marketed products when tested head-to-head.
“Looking ahead, Starpharma is well positioned for growth, with a strong balance sheet, growing sales revenue, an expanding portfolio of DEP® products and valuable corporate DEP® partnerships. Starpharma continues to champion its Environment, Social and Governance (ESG) pillars by creating important products that have the potential to make a significant contribution to the health and wellbeing of patients around the world.”
Key activities
Partnered DEP® Programs
Signed and commenced a second DEP® Research Agreement with MSD (Merck & Co., Inc.), building on our DEP® partnership in the innovative and valuable research area of antibody drug conjugates (ADCs).
Signed and commenced an exploratory DEP® Research Agreement with Genentech, which was expanded within six months of the initial agreement to include an additional DEP® program.
Under Starpharma’s DEP® licence with AstraZeneca, the global clinical program for AZD0466 continued to advance with multiple new sites opening and commencement of a new clinical trial in an additional cancer type – non-Hodgkin’s lymphoma (NHL).
Starpharma also continued to progress its DEP® program with Chase Sun, which involves the development of a DEP® anti-infective product for Chase Sun.
Starpharma continues to pursue further partnering opportunities for its DEP® drug delivery platform and active commercial discussions are underway in a number of research areas including DEP® radiotheranostics.
Internal DEP® Programs
Starpharma’s Phase 2 clinical trial of DEP® cabazitaxel continues to recruit well with 70 patients enrolled to date. During the year, Starpharma reported positive interim findings from the prostate cancer cohort of this trial, where 100% of evaluable patients treated with DEP® cabazitaxel demonstrated one or more efficacy signals. This trial continues recruitment of patients with ovarian and gastroesophageal cancers, following observation of encouraging efficacy signals in these tumour types, thereby expanding the market potential for DEP® cabazitaxel.
The DEP® irinotecan Phase 2 clinical trial continues to progress well, with 83 patients now enrolled. Efficacy signals including prolonged tumour shrinkage and reductions in tumour markers have been observed in multiple tumour types, including colorectal, breast, ovarian, pancreatic, lung, and oesophageal cancers. Enrolment of patients in the combination arm for DEP® irinotecan in combination with 5-FU + leucovorin (a commonly used combination treatment regimen in colorectal cancer) has now commenced.
The clinical program for DEP® docetaxel has enrolled 72 patients to date across the monotherapy and combination arms. 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 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 and site selection processes, regulatory and ethics preparations nearing completion.
Starpharma also 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® ADCs.
Marketed Products
Starpharma signed sales and distribution arrangements for VIRALEZE™ broad-spectrum antiviral nasal spray with commercial partners in Italy (ADMENTA Italia Group) and Vietnam (Health Co), and an agreement with Etqan & Nazahah for nine countries in the Middle East.
VIRALEZE™ was launched in Vietnam and Italy and relaunched in the UK through LloydsPharmacy.
Starpharma continued its scientific collaboration with The Scripps Research Institute to test VIRALEZE™ and SPL7013 against a range of respiratory viruses, including multiple variants of SARS-CoV-2[1] (Omicron and Delta) and influenza.
VIRALEZE™ demonstrated excellent protection against infection with the highly transmissible SARS-CoV-2 Omicron variant in a stringent in vivo viral challenge model[2]. These in vivo findings build on the in vitro findings reported by Starpharma earlier in the financial year, which showed that VIRALEZE™ achieved the maximal possible reduction of virus infectivity against the Omicron variant of SARS-CoV-2 in laboratory-based antiviral and virucidal assays.
The broad-spectrum activity of VIRALEZE™ was further demonstrated 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. SPL7013 also demonstrated irreversible virucidal properties against both types of influenza virus and outperformed other antiviral agents used in marketed nasal sprays.
VIRALEZE™ is registered in more than 30 countries and is available in pharmacies, retail outlets and online in a number of countries. Sales of VIRALEZE™ have significantly increased in FY22.
Starpharma continued to pursue registration and commercialisation for VIRALEZE™ in multiple other countries, with regulatory submissions in progress and 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 the Middle Eastern countries, 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 and registrations in other countries across Asia and the Middle East.
An important publication for VivaGel® BV was achieved in the highly regarded peer-reviewed European journal, Archives of Gynecology & Obstetrics. This publication will support marketing activities and importantly, the inclusion of the product in clinical management guidelines for BV.
Starpharma’s partner, Okamoto, launched a new VivaGel® condom range in Japan, under the brand name Pure Marguerite. The range is being distributed through major retail chains in Japan. Okamoto has also commenced regulatory processes for the VivaGel® condom in additional countries in Asia.
Corporate
Ms Lynda Cheng was appointed as an independent non-executive director on 1 August 2021. Ms Cheng has more than 25 years of experience as a finance executive including more than 15 years at Visy Industries/Pratt Holdings and 10 years in investment banking.
Dr Jeff Davies, former CSL executive, was appointed as an independent non-executive director on 1 April 2022, bringing over 35 years of biopharmaceutical industry experience to Starpharma’s Board.
Financials
Starpharma concluded FY22 in a strong financial position with a cash balance $49.9 million. Net operating cash outflows for the year were $13.2 million (FY21: $14.8 million). Receipts from customers and grants totalled $13.0 million, including receipts from customers of $4.8 million (FY21: $2.4 million) and R&D tax incentive of $7.7 million.
Revenue was up 128% to $4.9 million for the year, with $4.7 million for VIRALEZE™ and VivaGel® product sales, royalty, and research revenue from commercial partners. Interest income was $0.2 million for the year. Other income of $0.3 million, consisted of grant funding awarded by the Australian Government’s Medical Research Future Fund to expedite development and commercialisation of VIRALEZE™ (FY21: $0.9 million).
The loss after tax of $16.2 million (FY21: $19.7 million) includes expensing of all research and development expenditure and IP costs across the portfolio. The decreased loss compared to the prior year reflects the combination of higher sales and partner revenue and lower R&D expenditure due to the completion of VIRALEZE™ development and the stage and progression of DEP® internal clinical programs. The reduced loss reflects a favourable foreign exchange movement of $0.9 million over the prior year, primarily on foreign currency held.
Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 8MB)
[1] SARS-CoV-2 is the virus that causes COVID-19
[2] The study used the K18-hACE2 mouse model, which is an in vivo humanised mouse model that expresses the human angiotensin converting enzyme (hACE2) receptor, the receptor used by SARS-CoV-2 to infect cells in the human nasal cavity and respiratory tract.
This contains certain forward-looking statements.