Starpharma - Quarterly Cashflow and Activities Report

Melbourne, Australia - Starpharma (ASX: SPL, OTCQX: SPHRY) released its Appendix 4C - Quarterly Cashflow Report for the period ended 31 December 2021.

Starpharma's cash balance as at 31 December 2021 was $51.3 million. This does not include the $7.7 million R&D tax incentive that was recently received and announced in January.

Receipts from customers for the quarter were up 188% from the prior quarter, to $1.8 million. Receipts included sales of VIRALEZE to Vietnam following product launch in December.

Net operating cash outflows for the quarter were $4.2 million, down from $7.0 million last quarter. Cash outflows include clinical trial costs for Starpharma's three phase 2 DEP clinical programs, as well as scale-up and development costs for preclinical DEP candidates, including DEP gemcitabine, DEP radiopharmaceutical candidates and DEP ADCs. Other cash outflows include expenditure related to VIRALEZE product manufacture.

Key recent activities and events:

Starpharma reported positive interim results from the prostate cancer cohort of its phase 2 DEP cabazitaxel trial. 100% of patients assessed for efficacy following DEP cabazitaxel-treatment experienced one or more encouraging efficacy signals. These included reductions in tumour size, decreased PSA levels, and lack of progression of metastases in the bone. These very positive interim results compare favourably to conventional cabazitaxel (Jevtana) and 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. 55 patients have now been recruited across all cancer types in the phase 2 DEP cabazitaxel trial. Recruitment of a small number of additional ovarian and gastro-oesophageal cancer patients is ongoing following promising efficacy signals in both these tumours as well as prostate. Full results for the trial will be reported in the coming months once ongoing patients have completed treatment.

On 7 December 2021, Starpharma signed a new DEP Research Agreement with one of the world's largest biopharmaceutical companies. This new partnered DEP program is in addition to previously disclosed partnerships with Merck & Co., Inc., AstraZeneca, and Chase Sun.

AstraZeneca continues to recruit patients with advanced haematological malignancies (refractory AML- acute myeloid leukemia and ALL- acute lymphoblastic leukemia) into its global, phase 1/2 trial for DEP AZD0466, which is currently recruiting at sites in the USA, South Korea, and in Melbourne.

AstraZeneca recently advised that they expect to commence, in February, an additional international trial for AZD0466 in patients with non-Hodgkin's lymphoma - a blood cancer that accounts for more than 80,000 cancer diagnoses annually in the US and is one of the top 10 most commonly occurring cancers in most countries worldwide.

AstraZeneca and MD Anderson Cancer Center researchers presented new data for AZD0466 in two scientific poster presentations (Poster 1 and Poster 2) at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021. The ASH Annual Meeting is the world's premier event in malignant and non-malignant haematology and these poster presentations highlighted impressive activity of AZD0466 in different types of blood cancer.

On 3 December 2021, Starpharma signed a 5-year sales and distribution agreement for VIRALEZE antiviral nasal spray in Vietnam. The agreement includes a minimum commitment of at least 1 million units in the first year.

VIRALEZE was successfully launched in Vietnam in December following confirmation of the product's registration. Several launch events were held across Vietnam and attended by clinicians, healthcare professionals, politicians, and media networks. Starpharma has already supplied three large orders to Vietnam during the quarter, with further orders expected to be fulfilled shortly.

Following the signing of a sales and distribution agreement for VIRALEZE in Italy with leading pharmaceutical retail and wholesale distribution company, ADMENTA Italia Group, VIRALEZE was launched through ADMENTA's LloydsFarmacia. ADMENTA's LloydsFarmacia comprises ~260 retail pharmacies and an online platform.

VIRALEZE was recently registered for sale in Saudi Arabia, Vietnam, and New Zealand, adding to existing registrations for the product in Europe and India taking the number of countries where VIRALEZE is registered to more than 30 countries. The registration of VIRALEZE in Saudi Arabia is the first in the Middle East and will support further registrations in the region. Starpharma continues to liaise closely with the MHRA in the UK in relation to their query regarding promotional claims. Dialogue with the TGA continues, following our submission for registration in Australia. A number of other regulatory submissions for VIRALEZE in further countries and regions have also been made.

Negotiations are nearing completion for a distribution agreement for VIRALEZE in Saudi Arabia and other countries in the Middle East. This is in addition to commercial discussions for distribution of the product elsewhere, including in Europe, Asia, and other regions.

Testing of SPL7013, the antiviral agent in VIRALEZE, against the Omicron variant of SARS-CoV-2 is underway at The Scripps Research Institute. Antiviral and virucidal testing in laboratory studies has previously demonstrated that SPL7013 inactivates >99.9% of the Delta, Alpha, Beta, Gamma and Kappa variants of the coronavirus SARS- CoV-2.

DEP irinotecan clinical trial continues to progress well, with 68 patients now recruited, and multiple patients exhibiting encouraging efficacy signals, such as impressive and prolonged tumour shrinkage and reductions in tumour marker levels for multiple tumour types, including colorectal, breast, ovarian, pancreatic, lung and oesophageal cancer.

In parallel with ongoing phase 2 monotherapy investigations for DEP irinotecan, Starpharma is progressing a phase 1/2 combination arm that will investigate DEP irinotecan in combination with 5-FU + Leucovorin ('FOLFIRI'). FOLFIRI is a commonly used combination treatment regimen in colorectal cancer. Enrolment of patients in the DEP irinotecan combination arm is expected to commence shortly.

The DEP docetaxel clinical program continues to progress, with 66 patients now recruited (monotherapy and combination arms). Encouraging efficacy signals have been observed including prolonged stable disease and significant tumour shrinkage in heavily pre-treated patients with lung, pancreatic, oesophageal, cholangiocarcinoma and gastric cancers.

Additional DEP candidates are being progressed towards the clinic, including DEP gemcitabine. Final preclinical work is being completed, including scale-up, to facilitate DEP gemcitabine's entry into a phase 1/2 trial. The company also continues to develop multiple other preclinical DEP candidates, including in the area of DEP radiopharmaceuticals and DEP ADCs.

Starpharma continued to progress multiple partnered programs, including its DEP Antibody Drug Conjugate (ADC) program with Merck & Co Inc., DEP anti-infective program with Chase Sun and other DEP programs with named and unnamed partners. Additionally, further partnered DEP programs are at an advanced stage of negotiation with other leading pharmaceutical companies, including in the area of radiopharmaceuticals.

Starpharma continues to support marketing and regulatory activities for its VivaGel BV partners, Mundipharma and Aspen. VivaGel BV is currently registered in more than 45 countries.

Dr Jackie Fairley, Starpharma CEO, commented: 'Starpharma was very excited to announce the positive interim results for DEP cabazitaxel in prostate cancer from our phase 2 trial this quarter. Likewise, the recent decision by our partner, AstraZeneca, to expand its clinical program for AZD0466 to include non-Hodgkins lymphoma marks more exciting progress for this important oncology agent. In addition, we also announced the signing of a new DEP Research Agreement with one of the world's largest biopharmaceutical companies, adding to our existing partnerships with industry leaders AstraZeneca and Merck & Co., Inc., and Chase Sun. Each of these important milestones provide further validation for our DEP platform and illustrates the broad optionality of Starpharma's DEP technology.

'In parallel to our progress with DEP, Starpharma's antiviral nasal spray, VIRALEZE, was successfully launched in Vietnam, with Starpharma having received orders totalling more than $2 million to date. We were excited to see the product so well received and pleased to see VIRALEZE playing a role in the fight against COVID-19 in that region. The product was also launched in Italy, and registered in Saudi Arabia, Vietnam, and New Zealand, with further regulatory submissions in progress in other countries. Testing of SPL7013, the antiviral agent in VIRALEZE, against the globally important Omicron variant of SARS-CoV-2 is also underway at The Scripps Research Institute, following impressive results in the Delta variant. A key advantage of VIRALEZE is its mechanism of action, which appears to not be adversely impacted by mutations in the spike proteins of SARS-CoV-2 that make the virus more infectious, as has occurred in the Delta and Omicron variants.'

The closing cash balance as at 31 December 2021 was $51.3 million. Receipts from customers and grants in the quarter totalled $2.0 million, with net operating cash outflows of $4.2 million. The quarter includes significant investment in R&D ($2.6 million), product manufacturing and operating expenses ($0.6 million), reflecting investment in three phase 2 DEP clinical programs, scale-up and development of further DEP candidates, including DEP gemcitabine, DEP ADCs and DEP radiopharmaceutical products, and product manufacture of VIRALEZE. Staffing costs of $3.0 million, include non-executive and executive directors' fees of $438,000.

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

Contact:

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Starpharma Holdings Limited

Dr Jackie Fairley

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The Quarterly Cashflow and Activities Report is not subject to formal external audit or review. Management has procedures in place with relevant staff to allow the CEO and CFO to make appropriate certifications prior to approval.

Forward Looking Statements

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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