Feb 25, 2021

Interim Report and Half-Year Financial Results

Interim Report and Half-Year Financial Results

Melbourne, Australia; 25 February 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2020.

Key Financials

  • Cash balance at 31 December 2020 $70.3M (June 2020 $30.1M)
  • $47.0M net proceeds from equity placement and share purchase plan
  • Net operating cash outflows of $5.4M (pcp: $5.2M)
  • Receipt of $5.7M R&D tax incentive
  • Reported loss for half-year of $10.4M (pcp: $5.9M*). *Prior period included US$3 million AstraZeneca DEP® milestone

VIRALEZE™

  • Starpharma completed development of VIRALEZE™, its antiviral nasal spray. Device components were selected; branding created; artwork and packaging finalised; and European manufacturer contracted.
  • VIRALEZE™ European dossier was completed, and the product was successfully registered in Europe.
  • Manufacture of launch batches of VIRALEZE™ is underway, ahead of launch in Q1 CY21.
  • Marketing, e-commerce and B2B arrangements are well advanced to achieve product launch as soon as possible after regulatory approval. Licensing discussions have also progressed in parallel with launch preparations for certain jurisdictions.
  • Further antiviral testing of SPL7013 confirmed SPL7013 is virucidal, inactivating more than 99.99% of SARS-CoV-2, the virus that causes COVID‑19. SPL7013 also demonstrated potent activity in respiratory pathogen RSV (respiratory syncytial virus) and influenza.
  • The Medical Research Future Fund (MRFF) awarded Starpharma $1 million in matched grant funding for VIRALEZE™ following selection from more than 100 applications by an international industry panel.
  • Starpharma commenced a human study for VIRALEZE™ which is due to be completed in March. The study is designed to support commercialisation activities for VIRALEZE™.

VivaGel®

  • VivaGel® BV achieved TGA approval for an expansion of the marketing authorisation for VivaGel® BV (Fleurstat BVgel) to include the indication of prevention of recurrent bacterial vaginosis – bringing the approved indications for VivaGel® BV (Fleurstat BVgel) in line with those in Europe and Asia.
  • VivaGel® BV was launched in the Nordic region, new regulatory approvals were also received for countries in Africa and the Middle East, and further submissions are underway. The formal FDA review is ongoing, and COVID-19 has had an impact on timing.
  • Aspen’s Fleurstat BVgel campaign was awarded the 2020 Diamond Award for Best Launch of a Consumer Healthcare Product.

DEP® Drug Delivery Platform

  • AstraZeneca advised Starpharma of its planned expansion of the clinical DEP® program for AZD0466 to a global multi-centre study with an initial focus on haematological cancers.
  • Signed a Research Agreement with Merck & Co., Inc (MSD) to conduct a preclinical research evaluation of dendrimer based Antibody Drug Conjugates (ADCs) utilising DEP®
  • DEP® irinotecan phase 2 trial progressed, with encouraging efficacy signals observed for a number of tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. Preparations continue for the addition of clinical combinations with DEP® irinotecan, thereby expanding the market opportunity.
  • DEP® docetaxel clinical trials progressed with encouraging efficacy signals observed, including prolonged stable disease and tumour shrinkage in patients with pancreatic, oesophageal and gastric cancer. DEP® docetaxel + gemcitabine combination study commenced following compelling DEP® preclinical data and investigator interest.
  • DEP® cabazitaxel phase 2 trial progressed, with encouraging efficacy signals observed, including stable disease, significant target tumour shrinkage and substantial tumour marker reductions (e.g. PSA), in cancers including prostate, ovarian, lung, gastro-oesophageal, head and neck and other cancers.
  • Signed and commenced a new DEP® partnership with leading Chinese company Chase Sun to develop several DEP® nanoparticle formulations for an anti-infective drug with the view of enhancing its performance and expanding its therapeutic utility.
  • Developed and patented a DEP® version of Gilead’s remdesivir (Veklury®) with reduced injection volume and pharmacokinetic characteristics.
  • Progress and expansion of several internal DEP® pipeline programs, including ADCs and radiopharmaceutical candidates for both therapeutic and diagnostic applications.
  • Starpharma’s laboratory and internal operations continued to operate with minimal disruption, under a COVID safe plan.

Starpharma concluded the half-year in a very strong financial position with a cash balance of $70.3 million. The cash balance includes the net proceeds of $47.0 million from the completion of an equity placement and share purchase plan in the half-year.

Net cash outflows from operations of $5.4 million (pcp: $5.2 million) include costs of the internal DEP® drug delivery programs, including DEP® docetaxel, DEP® cabazitaxel, and DEP® irinotecan, and expenditure on VIRALEZE™ antiviral nasal spray.

Starpharma’s CEO, Dr Jackie Fairley, commented: “We achieved multiple significant milestones in the recent period, with the rapid development of VIRALEZE™ and signing two new DEP® partnerships, with Merck & Co., Inc in the area of ADCs, and with Chase Sun in the area of anti-infectives. These new partnerships illustrate the broad applicability of the DEP® platform and its use for multiple therapeutic areas. We also progressed our other partnered DEP® programs and recently announced AstraZeneca’s global expansion of its phase 1 trial for DEP® AZD0466 which is designed to expedite the development of this exciting novel drug”.

“Internally, we also saw good progress in the clinical trial programs for DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan – and we have continued to observe encouraging efficacy signals in each of these programs.”

Dr Fairley concluded: “We recently registered VIRALEZE™ in Europe, ahead of our original schedule. The rapid development of this novel product is a significant achievement. We are seeking to bring VIRALEZE™ to consumers and businesses as early as possible and anticipate the product will be available next month. We will focus on making VIRALEZE™ as widely available as possible given its potential to assist in the fight against the global pandemic,” concluded Dr Fairley.

Download ASX Announcement: Interim Report and Half-Year Financial Results (pdf file, 1.3MB)

pcp: prior corresponding period

 This contains certain forward-looking statements.