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Balstilimab Monotherapy Data Published in Gynecologic Oncology

On August 26, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer were published online in the international peer reviewed journal Gynecologic Oncology (View Source) (Press release, Agenus, AUG 26, 2021, View Source [SID1234586936]).

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"Publication of these data marks another significant achievement toward our objective to provide effective therapeutic options to those battling cancer," said Steven O’Day, MD, Chief Medical Officer of Agenus. "These data are drawn from the largest Phase 2 study to date evaluating PD-1 inhibition in advanced cervical cancer patients who have progressed on or after first-line chemotherapy; the results indicate balstilimab’s potential as an effective new therapy."

In the 140 evaluable patients, the objective response rate (ORR) in patients with PD-L1 positive tumors was 20.0% and included 3 patients (3/85, 3.5%) with a complete response and 14 patients (14/85, 16.5%) with a partial response. The median duration of response (DoR) was not reached after a 14.6-month median follow-up. Responses were also observed in the PD-L1 negative population with an ORR of 7.9%. The confirmed ORR for both PD-L1 positive and negative tumors was 15.0% and included 5 patients (3.6%) with a complete response and 16 patients (11.4%) with a partial response. The median DoR was 15.4 months and the disease control rate was ~50%. Notably, responses were observed across histologies, with responses in the squamous cell histology (ORR 17.6%) and in the more difficult to treat adenocarcinoma histology (ORR 12.5%). The safety profile was manageable and consistent with that of currently approved anti-PD-1 antibodies; it also compared favorably to the safety profiles of chemotherapies used in this population. Data from this trial continue to mature.

As discussed in the publication, these data suggest that balstilimab may be a differentiated anti-PD-1 antibody as compared to currently approved PD-1 inhibitors. In the KEYNOTE-158 trial of pembrolizumab, an anti-PD-1 antibody, in the same setting, an ORR of 14.6% was observed in the PD-L1 positive population and no responses were observed in the PD-L1 negative population. In addition, the noted 12.5% response rate of balstilimab in patients with cervical adenocarcinoma is significant as this subpopulation typically does not respond to immunotherapy and represents a growing proportion of advanced cervical cancer cases. Balstilimab thus provides the potential for therapeutic benefit to patient populations that do not typically respond to currently-available immunotherapy, both alone and in combination with other therapies, such as Agenus’ anti-CTLA-4 antibodies zalifrelimab and AGEN1181. Final results from a Phase 2 trial of balstilimab in combination with zalifrelimab in advanced cervical cancer will be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on September 19 from 11:35 – 11:40am ET by David O’Malley, MD.

"The efficacy and safety of balstilimab provides additional evidence of the importance of immune checkpoint blockade in the treatment of recurrent, advanced cervical cancer patients," said David O’Malley, MD, Professor, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine; Director, Division of Gynecologic Oncology, OSUCCC – James; and lead author on the publication. "Furthermore, responses to balstilimab were seen in patients who were PD-L1 positive, PD-L1-negative, bevacizumab pre-treated, and squamous cell and adenocarcinoma histologies. Balstilimab clearly provides clinical benefit in a broad range of cervical cancer patients."

Study Design (NCT03104699)
This was an open-label, single-arm, global Phase 2 clinical trial conducted at 60 sites throughout the United States, Europe, South America, and Australia. Patients were enrolled from November 20, 2017, to April 16, 2020, and received intravenous balstilimab at a dose of 3 mg/kg once every two weeks, given as a 60-minute infusion. Treatment was permitted for up to 24 months, or until disease progression, intolerable toxicity, or investigator/patient decision.

About Balstilimab Monotherapy
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Agenus announced it had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) on April 19, 2021, for use in patients with recurrent or metastatic cervical cancer, and the application is under priority review with a target action date of December 16, 2021.

Can-Fite Reports Second Quarter 2021 Financial Results & Provides Clinical Update

On August 26, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended June 30, 2021 (Press release, Can-Fite BioPharma, AUG 26, 2021, View Source [SID1234586935]).

Corporate and Clinical Development Highlights Include:

Can-Fite Entered into Development and Commercialization Agreement in $3 Billion Veterinary Osteoarthritis Market – Can-Fite entered into a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use. The canine osteoarthritis market is projected to reach $3 billion by 2024.

Can-Fite Received a Notice Allowance in China for its NASH Patent – During the second quarter, Can-Fite received a Notice Allowance in China for its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This patent, which has subsequently been issued to Can-Fite, addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, to reduce liver fat particularly in patients with NASH.

Patent Filed for A3AR-based Cannabis Compounds in the Treatment of Liver Diseases – Can-Fite’s preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer cell growth and also had an inhibitory effect on liver fibrosis, which is associated with NAFLD/NASH, cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.

Phase III Psoriasis Study Nears Completion of Enrollment – The Phase III Comfort study completed enrollment of 75% of planned patients during the second quarter, with full enrollment expected in the coming weeks. The study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla) in patients with moderate to severe plaque psoriasis. Topline results are expected Q1 2022.

Phase II COVID-19 Study Expands into Europe – Can-Fite’s ongoing Phase II study, under a U.S. FDA protocol, has been enrolling patients in Israel and expanded enrollment into Europe during the second quarter. The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in 40 patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines.

Phase IIb NASH Study Receives Clearance from Israeli Ministry of Health – Can-Fite received clearance from the Israeli Ministry of Health to commence a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH. Patient enrollment is expected to commence Q3 2021, ahead of the prior expected start date of Q4 2021. The Company expects to expand the study to additional clinical sites in Europe. A prior Phase IIa clinical trial of Namodenoson in the treatment of NASH met study endpoints showing anti-steatotic, anti-inflammatory, and anti-fibrotic effects.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite has completed preparatory work for its pivotal Phase III study and plans to submit its study protocol and plans to Institutional Review Boards (IRBs) at potential clinical sites. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival.

Fortified Balance Sheet

On June 30, 2021 Can-Fite had approximately $7.5 million in cash, cash equivalents, and short-term deposits. The Company closed an additional $10 million registered direct offering in August 2021.

"We expect multiple milestones in the coming months including topline results from our Phase III psoriasis study, in addition to the commencement of our pivotal Phase III in liver cancer and Phase IIb in NASH. We believe positive topline results may lead to further expansion of our global distribution strategy which has included significant non-dilutive funding," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the six months ended June 30, 2021 were $0.39 million compared to revenues of $0.40 million during the six months ended June 30, 2020. The decrease is considered immaterial.

Research and development expenses for the six months ended June 30, 2021 were $3.81 million compared with $7.05 million for the same period in 2020. Research and development expenses for the first half of 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first six months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the first six months of 2021. We expect research and development expenses will increase through 2021 and beyond.

General and administrative expenses were $1.89 million for the six months ended June 30, 2021 compared to $1.45 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees. We expect general and administrative expenses will remain at the same level through 2021.

Financial income, net for the six months ended June 30, 2021 was $0.20 million compared to financial expense, net of $0.12 million for the same period in 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investment.

Can-Fite’s net loss for the six months ended June 30, 2021 was $5.09 million compared with a net loss of $8.23 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of June 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $7.53 million as compared to $8.26 million at December 31, 2020. The decrease in cash during the six months ended June 30, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021 and from an advance payment of $2.25 million from a distribution agreement with Ewopharma which were offset by Company’s operating activity.

The Company’s consolidated financial results for the six months ended June 30, 2021 are presented in accordance with US GAAP Reporting Standards.

Affimed to Present at Upcoming Investor Conferences

On August 26, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that management will present and host one-on-one meetings at the following investor conferences during the month of September 2021 (Press release, Affimed, AUG 26, 2021, View Source [SID1234586934]).

Citi’s 16th Annual BioPharma Virtual Conference (September 8-10, 2021)
Date: Wednesday, September 8, 2021
No presentation, only one-on-one meetings
Location: Virtual

2021 Wells Fargo Virtual Healthcare Conference (September 9-10, 2021)
Date: Thursday, September 9, 2021
Presentation Time: 8:00 a.m. Eastern Time
Webcast: View Source
Location: Virtual

Morgan Stanley 19th Annual Global Healthcare Conference (September 9-15, 2021)
Date: Friday, September 10, 2021
No Presentation, only one-on-one meetings
Location: Virtual

Cantor Fitzgerald Virtual Global Healthcare Conference 2021 (September 27-30, 2021)
Date: Monday, September 27, 2021
Presentation Time: 10:00 a.m. Eastern Time
Webcast: View Source
Location: Virtual

For more information or to schedule a one-on-one meeting with Affimed’s management, please contact your conference representative or Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.

Allarity Therapeutics Announces Extraordinary Exercise Period for Warrants of Series ALLR TO 3 Set to August 30 – September 13, 2021

On August, 26, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that an accelerated extraordinary and final exercise period for warrants of the ALLR TO 3 series (the "TO 3 Warrants"), which were issued to subscribers of units in the Company’s preferential rights issue in May-June 2021, starts on August 30 and runs until September 13 (Press release, Allarity Therapeutics, AUG 26, 2021, View Source [SID1234586933]). Each warrant entitles the holder to subscribe for one (1) newly issued share at a subscription price of SEK 1.7.

In accordance with the terms of the TO 3 Warrants, as included in the prospectus for the rights issue published on May 19, 2021, the Company’s Board of Directors is entitled to determine an extraordinary and final exercise window of 10 trading days in which warrants shall be exercised provided, however, that the price of the Company’s shares increases to SEK 2.0 or more calculated as average volume weighted price (VWAP) over 10 trading days. The Board of Directors notes that the Company’s shares have been traded at a price of SEK 2.0 or more during a period of 10 ten trading days running from August 12 – August 25, 2021, calculated as average VWAP. The Board of Directors has determined that it is necessary to accelerate the exercise period for TO 3 Warrants in order to meet the requirements of, and complete, the previously announced US$ 20 million investment by 3i Fund (New York, NY) supporting the Company’s planned migration to the U.S. Nasdaq stock market. Accordingly, the Board of Directors sets an extraordinary and final exercise period as set out above.

It is important to note that, in correspondence with the warrant terms, the TO 3 Warrants which are not exercised at the latest September 13, 2021, or sold at the latest September 9, 2021, will become null and void without compensation or payment of any kind to the warrant holders. For the warrants not to lose their value, the holder must actively subscribe for new shares by exercise of the warrants or sell the warrants.

Summarized terms for exercising the warrants of series TO 3

Exercise period: August 30 – September 13, 2021.

Issue size: 145,003,680 warrants of series TO 3, which entitles to subscription of 145,003,680 shares. If all the warrants are exercised, the Company will receive approximately SEK 246.5 million before issuing costs.

Exercise price: SEK 1.7 per share.

Last day for trading warrants of series TO 3: September 9, 2021.

Dilution etc.: If all warrants are exercised the share capital will increase with DKK 7,250,184, from DKK 19,503,155.70, to DKK 26,753,339.7. If all warrants are exercised the number of shares will increase with 145,003,680 shares, from 390,063,114 shares, to 535,066,794 shares. The dilution at exercise of all warrants amounts to 27.1 percent of the number of shares.

How warrants are exercised

Nominee-registered warrants (Custody account):

Subscription and payment by exercise of warrants shall be made in accordance with instructions from each nominee bank. Please contact your nominee bank for additional information.

Examples of nominee-registered warrants are, in most cases, warrants in accounts in Avanza or Nordnet.

Direct-registered warrants (Securities account):

No accounts for issuing nor any instructions regarding payments will be sent out. Subscriptions will be made through simultaneous payment in accordance with the instructions on the application form.

The application form including instructions for payment will be available at Allarity’s website, www.allarity.com and on Hagberg & Aneborn Fondkommission AB’s website, www.hagberganeborn.se.

Following subscription, the warrants will be replaced by interim shares awaiting registration at the Danish Business Authority.

Important dates for warrants of series TO 3

August 30, 2021 – The exercise period begins

September 9, 2021 – Last day of trading in the warrants of series TO 3

September 13, 2021 – The exercise period ends

September 15, 2021 – Expected date for publication of the warrant exercise outcome

September 28, 2021 – Expected date for conversion of interim shares to shares

Advisers

Hagberg & Aneborn Fondkommission AB the issuing agent. Mazanti-Andersen Advokatpartnerselskab is legal advisor to the Company.

Starpharma annual report and full year financial results (ASX Announcement)

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]).

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.