Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2019.

Financial Results

• Cash position at 30 June of $41.3M
• Net cash burn[1] of $10.1M (FY18: $9.9M)
• Total revenue and other income of $2.7M (FY18: $5.0M)
• Reported loss of $14.3M (FY18: $10.3M)
• Receipt of $4.0M R&D tax incentive

Key activities

VivaGel^®

• VivaGel^® BV launched in Europe by Mundipharma, under the brand name Betadine BV^TM;
• VivaGel^® BV launched in Australia by Aspen Pharmacare, under the brand name Fleurstat BVgel;
• VivaGel^® BV was licensed to ITF Pharma, Inc. for the US for milestones of up to US$101 million in addition to escalating royalties;
• First Asian regulatory approvals received for Betadine^TM BV Gel;
• VivaGel^® condom launched in Japan under Okamoto’s Zero Zero Three (‘003’) brand;
• US FDA completed its review of the VivaGel^® BV NDA and advised it requires confirmatory clinical data prior to approval; and
• Positive independent market research was conducted in the US for SPL7013 ophthalmic drops for viral conjunctivitis and a patent was granted for the product.

DEP^® drug delivery

• Starpharma signed a Development and Option Agreement with AstraZeneca to progress the development of a DEP^® version of one of their major marketed oncology medicines;
• First patent granted for Starpharma’s DEP^® dendrimers with AstraZeneca’s Bcl2/xL inhibitors, including AZD0466;
• Clinical trials for DEP^® docetaxel (phase 2) and DEP^® cabazitaxel (phase 1 / 2) progressed well with new sites opened and cohorts expanded;
• Approval to commence DEP^® irinotecan phase 1 / 2 trial;
• DEP^® irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar^®) and cetuximab (Erbitux^®), in the irinotecan-refractory HT-29 human colon cancer model;
• DEP^® irinotecan showed impressive efficacy and safety benefits over standard irinotecan in combination with 5-FU in a human pancreatic cancer model;
• DEP^® docetaxel and DEP^® cabazitaxel outperformed both gemcitabine and Abraxane^® in a human pancreatic cancer model; and
• A range of DEP^® radiopharmaceutical and other DEP^® candidates are undergoing testing in a variety of models.

Starpharma CEO, Dr Jackie Fairley, commented: “Starpharma has achieved significant milestones across the business this year, including international product launches, new commercial deals, and trial progress for our three high-potential, clinical-stage DEP^® products. The company is in a strong financial position with more than $40 million in cash at bank. With our anticipated revenues from products on market and future launches, we are well placed for future growth”.

Commenting further on the 2019 financial year’s achievements and outlook, Dr Fairley added: “During the year, VivaGel^® BV was launched in both Europe and Australia and we recently received the first Asian regulatory approvals for this breakthrough product. VivaGel^® BV has now been licensed for more than 160 countries and we look forward to further approvals and launches in the coming months across Mundipharma’s regions. We also negotiated an attractive licensing deal for VivaGel^® BV in the US with specialty pharmaceutical company, ITF Pharma, Inc., however the US regulator has requested confirmatory data and Starpharma is currently working to pursue approval as quickly as possible to bring this innovative product to the US market”.

“In our DEP^® portfolio, we were delighted to add another commercial deal with AstraZeneca for a DEP^® version of one of their major marketed oncology products, and are excited for the first DEP^® IND to be filed by AstraZeneca for AZD0466. We also progressed with our own internal clinical DEP^® programs - reporting positive interim results for both DEP^® docetaxel and DEP^® cabazitaxel - and recently advanced our third internal DEP^® product, DEP^® irinotecan, into the clinic. We also added a suite of excellent preclinical data from our DEP^® platform, further demonstrating the versatility of our drug delivery technology, and we continued to build our pipeline of DEP^® candidates”.

“In the year ahead, we look forward to our partner’s further launches of VivaGel^® BV and building sales momentum, while progressing our three clinical stage internal DEP^® products alongside AstraZeneca’s first DEP^® product, AZD0466. We also continue to explore the potential expansion opportunities for our clinical programs into new indications and combination therapies to build further value in our DEP^® products and to create the greatest potential for patient outcomes”, concluded Dr Fairley.

Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 4.5MB)

[1] Net cash burn is considered a non-IFRS value and has not been audited in accordance with Australian Accounting Standards. Net cash burn is calculated by the movement in cash and cash equivalents from 30 June 2018 to 30 June 2019.