Jan 28, 2022

Quarterly Cashflow and Activities Report (ASX Announcement)

Quarterly Cashflow and Activities Report (ASX Announcement)

Melbourne, Australia; 28 January 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) today 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® 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.

Download full announcement here: Quarterly Cashflow and Activities Report (PDF 694KB)

 This contains certain forward-looking statements.