On August 26, 2021 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its annual report and financial results for the year ended 30 June 2021 (Press release, Starpharma, AUG 26, 2021, View Source [SID1234586932]).

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Financial Results

Cash position at 30 June 2021 of $60.5M
Net cash burn[1] of $16.5M[2] (FY20: $2M)
Receipt of $5.7M R&D tax incentive
Total revenue and other income of $3.5M (FY20: $7.1M); Revenue in the prior year included $4.3 million from AstraZeneca for a US$3 million development milestone
Reported loss of $19.7M (FY20: $14.7M)
Key activities

VIRALEZE

Developed VIRALEZE, a novel antiviral nasal spray using already approved agent, SPL7013, and undertook scale-up, manufacturing, and other supply chain activities, ahead of launch.
Registered VIRALEZE in Europe and India, and progressed regulatory activities for countries in multiple other regions.
On 25 March 2021, signed a sales and distribution agreement for VIRALEZE with LloydsPharmacy, one of the largest pharmacy groups in the UK.
LloydsPharmacy launched VIRALEZE in the UK online on 30 March 2021 and in-store in April 2021.
Starpharma launched VIRALEZE in countries in Europe in May 2021 via its dedicated product webstore.
Advanced commercial discussions for local distribution arrangements for VIRALEZE in India and in a number of other countries, including various European countries and other international regions.
Conducted extensive antiviral testing on the VIRALEZE antiviral agent:
Confirmed SPL7013 is virucidal against important coronavirus SARS-CoV-2[3] variants Delta, Alpha, Gamma, Beta and Kappa, in laboratory studies.
Demonstrated potent activity of SPL7013 against respiratory pathogen RSV (respiratory syncytial virus) and influenza, in laboratory studies, further expanding the potential uses for VIRALEZE.
Confirmed SPL7013 is active against other pandemic respiratory viruses "SARS" and "MERS", in laboratory studies, supporting the potential use of VIRALEZE in future pandemics.
Published extensive antiviral data for SPL7013 (the antiviral agent in VIRALEZE) in the prestigious international scientific journal, Antiviral Research[4].
In a SARS-CoV-2 challenge in vivo in a humanised mouse model of coronavirus infection, VIRALEZE administered nasally reduced viral load by >99.9% (vs. saline control) in the lungs and trachea of animals challenged with SARS-CoV-2.
Awarded $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of VIRALEZE.
Successfully completed a clinical safety study in humans, in which VIRALEZE was safe and very well tolerated, with no absorption of SPL7013 into the bloodstream
DEP Drug Delivery Platform

AstraZeneca expedited and expanded its DEP AZD0466 clinical program, into a multi‑region phase 1/2 trial, with an initial focus on haematological cancers to support rapid development and registration.
Continued progress and recruitment into DEP irinotecan phase 2 trial, with 54 patients now recruited, with multiple patients exhibiting encouraging efficacy signals observed, including impressive tumour shrinkage and reductions in tumour marker levels for multiple tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. Clinical trial preparations continue for the addition of combinations with DEP irinotecan, thereby expanding the potential market opportunity.
Continued progress and recruitment into DEP docetaxel clinical trials with 50 patients now recruited and with multiple patients exhibiting encouraging efficacy signals observed, including prolonged stable disease, significant tumour shrinkage, reductions in tumour marker levels including in patients with hard-to-treat tumours such as pancreatic, oesophageal, cholangiocarcinoma, and gastric cancer.
Continued progress and recruitment into DEP cabazitaxel phase 2 trial with 42 patients now recruited and with multiple patients exhibiting efficacy signals in prostate cancer, including radiological responses, significant reductions in prostate-specific antigen (PSA) and lack of new bone metastases. Multiple heavily pre-treated patients also exhibited efficacy signals in gastro-oesophageal, ovarian, cholangiocarcinoma, lung, thymic and head and neck cancers.
Signed a Research Agreement with Merck & Co., Inc., (MSD) to conduct a preclinical research evaluation of dendrimer-based Antibody Drug Conjugates (ADCs) utilising Starpharma’s DEP
Signed and commenced a new DEP partnership with leading Chinese pharmaceutical company Chase Sun to develop several DEP nanoparticle formulations for an anti-infective drug.
Starpharma’s second radiopharmaceutical candidate, DEP HER2-lutetium, outperformed in a human breast cancer model.
Progressed development of several internal DEP candidates and programs, including DEP gemcitabine, DEP ADCs, and DEP radiopharmaceutical candidates for both therapeutic and diagnostic applications.
Starpharma continued to progress its undisclosed DEP partnered programs.
Developed and patented a DEP version of Gilead’s remdesivir (Veklury) with improved injection volume and pharmacokinetic characteristics.
Starpharma was invited to present its DEP technology at the prestigious, international Controlled Release Society (CRS) Virtual Annual Meeting, during a session called ‘Success Stories from Bench to Trials to Market’.
VivaGel Portfolio

VivaGel BV achieved TGA approval for an expansion of the marketing authorisation for VivaGel BV (Fleurstat BVgel) to include 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, and new regulatory approvals were also received for countries in Africa and the Middle East, and further submissions were prepared.
In the US, a formal dispute resolution process is ongoing with the FDA as part of the regulatory process for VivaGel BV, and COVID-19 has had an impact on timing.
LifeStyles launched the VivaGel condom in countries in Europe, marketed under LifeStyles’ Manix and Akuel brands of condoms as the Absolute Dual Protection condom.
Corporate activities

Starpharma completed an oversubscribed A$48.9 million share placement and share purchase plan.
Starpharma concluded the year in a strong financial position with a cash balance of $60.5 million. Cash inflows from financing activities for the financial year include net proceeds of $46.9 million resulting from an equity placement and share purchase plan completed in September/October. Revenues for the year totalled $2.2 million, including $1.8 million for product sales, royalty, and research revenue from commercial partners, and interest income of $0.4 million. Other income of $1.3 million included $0.9 million of grant funding awarded by the Australian Government’s Medical Research Future Fund to expedite development and commercialisation of VIRALEZE. The net loss after tax for the year was $19.7 million, compared to $14.7 million last year. The key driver of this movement was the $4.4 million reduction in revenue in FY21 compared to the prior year due to the receipt of a US$3 million milestone payment from AstraZeneca in FY20. There was also a $1.1 million unfavourable unrealised foreign exchange movement (loss in FY21 of $0.8 million, gain in FY20 of $0.3 million) on foreign currencies held during FY21, compared to the prior corresponding period. Following the first launch of VIRALEZE in late March 2021, the product’s revenue for FY21 was $0.8 million. Starpharma originally supplied LloydsPharmacy with $1.4 million of VIRALEZE product, of which $0.7 million of revenue was not recognised for FY21 with stock returned following the temporary pause of sales and the likely repackaging requirements. Returned UK stock is scheduled to undergo repackaging shortly, incorporating a longer shelf-life as additional stability data is now available. This stock will then be made available for sale with the extended shelf-life.

Starpharma CEO, Dr Jackie Fairley, commented: "2021 has been a remarkable year for all of us around the world. Despite the impact of the unrelenting global pandemic, Starpharma was able to continue to recruit into our three DEP phase 2 clinical programs and achieve a number of important commercial milestones across the business. These included the rapid development and launch of VIRALEZE and the continued rollout of VivaGel products, as well as two new commercial DEP partnerships, and important progress for our three internal DEP phase 2 products. In parallel, we continued to build and advance new DEP assets into the preclinical pipeline in exciting and high-value areas like radiopharmaceuticals and Antibody Drug Conjugates (ADCs).

"It was fantastic to see our partner AstraZeneca expedite and expand its clinical program for their first DEP product, AZD0466, into a multi-region phase 1/2 study with the aim of facilitating marketing approvals as soon as possible. We also signed an exciting new partnership with leading global pharmaceutical company MSD (Merck & Co., Inc.) in the area of DEP ADCs, and progressed commercial discussions with potential partners for further potential DEP agreements. Internally, each of our three phase 2 clinical trials for DEP docetaxel, DEP cabazitaxel, and DEP irinotecan continued to recruit well despite the impact of COVID-19. We also developed further DEP assets, including DEP radiopharmaceutical candidates, into the preclinical pipeline".

Commenting on VIRALEZE, Dr Fairley said "The company is extremely proud to have developed, registered and launched VIRALEZE ahead of schedule and in time for it to play a role in the evolving situation in Europe. We were pleased to launch the product in the UK via LloydsPharmacy and online in other parts of Europe. VIRALEZE is now also registered in India and available online to consumers in multiple regions. Throughout the year, Starpharma continued to test SPL7013, the antiviral agent in VIRALEZE, against further respiratory viruses and new variants of SARS-CoV-2 as they emerged, with multiple laboratory studies showing that SPL7013 is virucidal, inactivating >99.9% against all four ‘Variants of Concern’, including the important Delta variant. The broad-spectrum activity of SPL7013 against multiple viruses and new variants is an important feature for the product, which demonstrates the potential further uses for VIRALEZE.

"In the year ahead, we will continue to advance our clinical DEP assets and expand our portfolio by progressing preclinical programs and leveraging Starpharma’s DEP platform to engage with new potential partners and increase market opportunities. The company also remains on track to progress further registrations, distribution arrangements and launches for VIRALEZE in other regions, while also supporting its partners to progress further registrations and launches of VivaGel products," concluded Dr Fairley.

Starpharma has published a standalone ESG (Environment, Social & Governance) Report which is available at View Source

Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 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 between reporting periods, adjusted for the impact of the capital raising during the period.

[2] Excluding the $46.9 million of equity raising net proceeds.

[3] SARS-CoV-2 is the virus that causes COVID-19.