Starpharma : Interim Report and Half-Year Financial Results

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Starpharma Interim Report and Half-Year Financial Results

Melbourne, Australia; 21 February 2022: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2021.

Key Financials

• Cash balance at 31 December 2021 $51.3M, excluding $7.7M received in January 2022 for the FY21 R&D tax incentive refund
• Revenue of $1.9M, up 200% on the prior corresponding period (pcp), including significant sales of VIRALEZE™ in Vietnam following the product's launch in December 2021
• Net operating cash outflows of $11.2M, excluding $7.7M of R&D tax incentive refund
• Reported loss for half-year of $8.4M, 19% lower than pcp of $10.4M

VIRALEZE™

• Successfully launched VIRALEZE™ in Vietnam following registration of the product and signing of a sales and distribution agreement in Vietnam. VIRALEZE™ is now available through a number of the largest pharmacy chains in Vietnam both in store and online. Collectively, these pharmacy chains have ~1300 pharmacies throughout Vietnam.
• VIRALEZE™ registration was achieved in Saudi Arabia. This registration will be used to facilitate further registrations across the Middle East.
• Signed a sales and distribution agreement with Etqan & Nazahah (E&N), headquartered in Saudi Arabia, for VIRALEZE™. The agreement covers nine countries, including the entire Gulf Cooperation Council region (Saudi Arabia, United Arab Emirates, Qatar, Kuwait, Omar, and Bahrain).
• VIRALEZE™ was launched in Italy through LloydsFarmacia following signing of a sales and distribution agreement for VIRALEZE™ with ADMENTA Italia Group in the period. ADMENTA is a leader in pharmaceutical retail and wholesale distribution in Italy and the Italian holding company of McKesson Europe.
• In addition to Saudi Arabia, new registrations were also achieved for VIRALEZE™ in Vietnam, and New Zealand, bringing the number of countries where VIRALEZE™ is registered to more than 30, including in Europe. Regulatory processes are ongoing in a number of markets, including Australia and other countries in the Middle East. In the UK, dialogue continues between Starpharma and the UK regulator, MHRA.
• Impressive data established that SPL7013, the antiviral agent in VIRALEZE™, has potent virucidal activity (>99.99%) against the globally significant Delta variant of SARS-CoV-2. Antiviral testing at The Scripps Research Institute has now confirmed that SPL7013 has >99% virucidal activity against four of the WHO-designated SARS- CoV-2 variants of concern (Alpha, Beta, Gamma, Delta) in laboratory studies, as well as the closely related Kappa variant.
• Testing of SPL7013 against the Omicron variant is well advanced at The Scripps Research Institute.
• VIRALEZE™ demonstrated a high level of protection against SARS-CoV-2 in a WHO-recommended humanised mouse challenge model of coronavirus infection. VIRALEZE™ reduced viral load by >99.9% in the lungs and trachea of animals

pcp: prior corresponding period

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challenged with SARS-CoV-2 (vs. saline control) when administered nasally. These results were published in the international peer-reviewed journal Viruses.

• VIRALEZE™ was shown to be safe and extremely well tolerated in a repeat-dose human clinical safety study. Results of the study also confirmed that SPL7013, in VIRALEZE™, is not absorbed into the bloodstream following nasal application, which is consistent with extensive previous nonclinical and clinical data.
• Extensive antiviral data for SPL7013 was published in the prestigious international scientific journal, Antiviral Research. In addition, SPL7013 was featured in the October 2021 issue of Nature Biotechnology.

DEP® Drug Delivery Platform

• Starpharma signed an exploratory DEP® Research Agreement with Genentech, a member of the Roche Group, building on our partnered DEP® programs with global companies, including AstraZeneca, Merck & Co., Inc, and Chase Sun, which continue to progress. Work for this exploratory program commenced during the half- year.
• Starpharma announced extremely positive interim results for the prostate cancer patient cohort of its DEP® cabazitaxel phase 2 clinical trial. Following treatment with DEP® cabazitaxel, 100% of patients assessed for efficacy demonstrated one or more encouraging efficacy signals (tumour shrinkage, PSA reduction, and/or lack of secondary bone disease progression). Recruitment of a small number of additional ovarian and gastro-oesophageal cancer patients continues following promising efficacy signals in both these tumours as well as prostate.
• The US Patent and Trademark Office granted a new 'composition of matter' patent for DEP® cabazitaxel, with a patent term to 2039 and the potential for a further 5-year extension.
• AstraZeneca continued to recruit patients with advanced haematological malignancies and open new sites in its global phase 1/2 clinical trial for DEP® AZD0466, which is currently recruiting in the USA, South Korea, and Australia.
• AstraZeneca recently announced a new multi-centre phase 1/2 trial of AZD0466, which is expected to commence shortly. This new trial is investigating AZD0466 in patients with advanced non-Hodgkin's lymphoma, which is one of the top 10 most commonly occurring cancers.
• AstraZeneca and MD Anderson Cancer Center researchers reported exciting new data for AZD0466 at the American Society of Hematology (ASH) Annual Meeting in December 2021. Work conducted at MD Anderson showed that AZD0466 in combination with acalabrutinib overcame therapeutic resistance in aggressive venetoclax-resistant mantle cell lymphoma (MCL) models. MCL is an aggressive subtype of non-Hodgkin's lymphoma.
• The DEP® irinotecan phase 2 trial progressed well with encouraging efficacy signals observed across a range of tumours, including colorectal, breast, platinum-resistant ovarian, pancreatic, lung, and oesophageal.
• Preparations continue for the addition of a phase 1/2 combination arm of DEP® irinotecan + 5-FU + Leucovorin ('FOLFIRI'). FOLFIRI is a commonly used combination treatment regimen for colorectal cancer. This combination arm will run in parallel with the ongoing monotherapy arm for DEP® irinotecan, with recruitment of patients expected to commence shortly.
• The DEP® docetaxel clinical program (monotherapy and combination arms) progressed with efficacy signals observed, including prolonged stable disease and significant tumour shrinkage in heavily pre-treated patients with lung, pancreatic, oesophageal, cholangiocarcinoma and gastric cancers.

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• Preparations for DEP® gemcitabine's commencement of a phase 1/2 clinical trial, including manufacture of clinical product, are well advanced.
• Starpharma continued to progress additional DEP® candidates towards the clinic, including DEP® Antibody Drug Conjugates (ADCs) and DEP® radiopharmaceutical candidates for both therapeutic and diagnostic applications.
• Work continued on Starpharma's multiple partnered DEP® programs, including the DEP® ADCs program with Merck & Co., Inc., and DEP® anti-infective program with Chase Sun. In addition, Starpharma is negotiating further partnered DEP® programs with other leading pharmaceutical companies and is also conducting discussions in relation to a number of internal candidates.

VivaGel®

• VivaGel® products are currently registered in more than 45 countries and available for sale in Europe, Japan, South East Asia, South Africa, Australia and New Zealand.
• Starpharma continues to support marketing and regulatory activities for its VivaGel® BV partners, Mundipharma and Aspen.
• Fleurstat BVgel marketing activities continued in Australia, including digital marketing campaigns, promotional items in women's health and lifestyle print media, and shopping centre advertising.
• Okamoto is preparing to launch a new VivaGel® condom brand in Japan and continues regulatory activities for the VivaGel® condom in a number of other Asian markets.

Revenue of $1.9 million for the half-year is up 200% on the prior corresponding period for product sales, royalty, and research revenue from commercial partners. The increase in revenue was contributed to by sales of VIRALEZE™ antiviral nasal spray, following launch in new international markets, including Vietnam. Starpharma concluded the half-year in a very strong financial position with a cash balance of $51.3 million. The 31 December 2021 cash balance excludes the receipt in January of $7.7M of R&D tax incentive refund.

The loss for the period of $8.4M, reduced by 19%. This improvement was driven by increased product sales of VIRALEZE™ and lower expenses. R&D expenditure reflects the continued investment in the company's internal DEP® drug delivery programs, including its three clinical- stage DEP® products - DEP® docetaxel, DEP® cabazitaxel, and DEP® irinotecan - as well as the further development of additional DEP® candidates towards the clinic, such as DEP® gemcitabine and the broader DEP® pipeline.

Dr Jackie Fairley, Starpharma CEO, commented: "Starpharma has achieved a number of valuable milestones throughout the half-year across our DEP® portfolio. We were delighted to sign a new DEP® Research Agreement with a leading global pharmaceutical company. This new partnership builds on our existing relationships with AstraZeneca, Merck & Co., Inc., and Chase Sun. It has also been exciting to see AstraZeneca expand the potential indications for AZD0466 through a new clinical trial in patients with advanced non-Hodgkin's lymphoma, which is expected to commence shortly.

"In parallel with our partnered DEP® programs, Starpharma also progressed its three internal clinical programs for DEP® cabazitaxel, DEP® docetaxel, and DEP® irinotecan. We reported positive interim findings from the prostate cancer cohort of the DEP® cabazitaxel phase 2 trial, showing that all patients assessed for efficacy experienced one or more efficacy signals following treatment with DEP® cabazitaxel. We have continued to observe encouraging efficacy signals in all programs.

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"Our broad-spectrum antiviral nasal spray, VIRALEZE™, was launched in Vietnam and Italy, following the signing of a sales and distribution agreement with partners in those regions. VIRALEZE™ is now registered in more than 30 countries, including in Europe, India, Vietnam, New Zealand, and Saudi Arabia and also available online in certain other markets. Most recently, we expanded the distribution arrangements for VIRALEZE™, adding nine new countries through sales and distribution with E&N. Commercialisation in the Middle East will commence with Saudi Arabia where the product is already registered and launch preparations are well advanced," concluded Dr Fairley.

About Starpharma

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a global biopharmaceutical company and a world leader in the development of new pharmaceutical and medical products based on proprietary polymers called dendrimers, with programs for respiratory viruses, DEP® drug delivery and VivaGel®. Starpharma has developed VIRALEZE™, an antiviral nasal spray that is registered for sale in the Europe, Vietnam, India, Saudi Arabia, and New Zealand, and available outside Australia in certain markets online. VIRALEZE™ is not approved for sale or supply in Australia. SPL7013 is utilised in approved products - the VivaGel® condom and VivaGel® BV. VivaGel® BV has been licensed in >160 countries, is registered in >45 countries and available for sale in the UK, Europe, Japan, South East Asia, South Africa, Australia and New Zealand.

As a leading company in dendrimer-based drug delivery, Starpharma's proprietary drug delivery platform technology, DEP®, is being used to improve pharmaceuticals, to reduce toxicities and enhance their performance. There are numerous internal and partnered programs underway to develop DEP® versions of existing drugs, particularly in the area of anti-cancer therapies. DEP® partnerships include oncology programs with AstraZeneca, with Merck in the area of Antibody Drug Conjugates (ADCs), with Chase Sun in the area of anti-infectives and other world leading pharmaceutical companies. Starpharma's partnered DEP® programs have the potential to generate significant future milestones and royalties.

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Media: Summit Media

Grant Titmus

Mob: [phone] [e-mail]

Forward Looking Statements

Starpharma.com|Twitter|LinkedIn

Starpharma Holdings Limited

Dr Jackie Fairley, Chief Executive Officer Nigel Baade, CFO and Company Secretary [phone]

[e-mail]

4-6 Southampton Crescent

Abbotsford Vic 3067

Disclosure

This ASX Announcement was authorised for release by the Chairman, Mr Rob Thomas.

For

This document contains certain forward-looking statements, relating to Starpharma's business, which can be identified by the use of forward-looking terminology such as "promising", "plans", "anticipated", "will", "project", "believe", "forecast", "expected", "estimated", "targeting", "aiming", "set to", "potential", "seeking to", "goal", "could provide", "intends", "is being developed", "could be", "on track", or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA's and other authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product.

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use	Starpharma Holdings Limited
personalResults for Announcement to the Market	ABN 20 078 532 180
2
			Interim Report - 31 December 2021
			Lodged with the ASX under Listing Rule 4.2A
			This information should be read in conjunction with the 30 June 2021 Annual Report and any public announcements made by Starpharma
			Holdings Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations Act
			2001.
	Contents
		Di ectors' Report	3
For		7
		Auditor's Independence Declaration
		Interim Financial Report	8
		Independent Auditor's Review Report to the Members	17

STARPHARMA HOLDINGS LTD ABN 20 078 532 180

4-6 Southampton Crescent, Abbotsford 3067, Victoria, Australia

www.starpharma.com