Destiny Pharma and SporeGen® announce collaboration and Innovate UK grant award to co-develop novel, preventative treatment for COVID-19

• SPOR-COV^TM prophylactic approach targets the innate immune system with potential to develop COVID-19 protection within a few days of treatment
• Innovate UK grant of £800,000 to support SPOR-COV programme over the next 18 months
• Expands Destiny Pharma’s novel pipeline targeted at preventing infections

Brighton, United Kingdom – 7 September 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel, hospital infection prevention treatments that address the global challenge of antimicrobial resistance (AMR), today announces that it has entered into a collaboration agreement with SporeGen Limited (“SporeGen”), a UK biotechnology company working exclusively on Bacillus and its applications, to co-develop SporeGen’s SPOR-COV product as a novel, preventive treatment for COVID-19.

Under the agreement, the parties will share any costs and commercial returns from SPOR-COV and plan to complete a pre-clinical programme with the aim of being ready to enter the first human clinical trials within 18 months. Destiny Pharma’s expertise in pre-clinical and clinical drug development will be combined with SporeGen’s world leading understanding of Bacillus bacterial spores to progress the SPOR‑COV project.

The SPOR‑COV product consists of a proprietary formulation of Bacillus bacteria that will be administered nasally as a spray. SPOR-COV has already been shown by SporeGen to provide complete (100%) protection in preclinical models of influenza virus. SporeGen has IP protection supporting the SPOR‑COV approach and this will be expanded during the project.

SPOR-COV is different to vaccines in that it utilises the innate immune system with the aim of developing COVID-19 protection a few days after dosing. As an “easy to use” first line of defence, it has the potential to reduce COVID-19 infection rates and transmission significantly. The final SPOR-COV product is planned to be straightforward to produce at high volumes and at low cost. Additional attributes are that it could be stockpiled almost indefinitely without the need for cold chain refrigeration as it is a very stable product. It could be made available globally as a cost-effective measure in the fight against COVID-19 as well as new COVID strains and other respiratory viral infections.

£800,000 grant from Innovate UK (IUK) to support SPOR-COV preclinical programme

Destiny Pharma and SporeGen are also very pleased to announce that IUK has awarded a grant of £800,000 to fund the majority of the £1 million cost of the initial SPOR-COV programme. The preclinical efficacy work will be undertaken in collaboration with Professor Aras Kadioglu, at University of Liverpool who is Professor of Bacterial Pathogenesis in the Department of Clinical Infection, Microbiology & Immunology,  where he heads the Bacterial Pathogenesis and Immunity group and is a leading expert in respiratory infection models and host immunity to infection. The manufacturing and formulation development work will be carried out by HURO, an experienced manufacturer of bacterial product formulations based in Vietnam and part of PAN Group. The plan is to complete the required pre-clinical safety and efficacy studies and also develop the manufacturing process in the next 18 months and be ready to commence the first human clinical studies thereafter.

Professor Simon Cutting, Chief Executive of SporeGen, said: “The SPOR-COV platform has already been shown to be effective against pandemic flu by targeting the innate immune system. As such, SPOR-COV potentially has value as a universal system for combatting other viral diseases such as COVID-19. If successful, we foresee a novel approach against COVID-19 and for future, similar pandemics. The SPOR-COV approach, unlike traditional vaccination, focuses on innate immunity and may not be impaired by new mutational variants. A further attribute of SPOR-COV is that it can be produced and stockpiled with ease and does not require a cold-chain. Prima facie our approach is simple and offers a potential new approach in the fight against one of the most serious diseases to afflict mankind".

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are excited to announce the collaboration with SporeGen to co-develop their SPOR-COV product to prevent COVID-19 infections and the concurrent award of significant grant funding from Innovate UK. We are also pleased to be working with Professor Kadioglu at the University of Liverpool who has world class virology expertise. Destiny Pharma is committed to building a novel pipeline targeted at preventing infections and is very pleased to now be working with partners on the SPOR-COV project alongside our existing in-house XF platform.  The ongoing coronavirus pandemic has highlighted powerfully the need for innovation in developing new treatments to prevent and manage both viral and bacterial infections and Destiny Pharma remains committed to developing cost-effective products that meet this medical need”.

ENDS

The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.

For further information, please contact:

Destiny Pharma plc

Neil Clark, CEO

Shaun Claydon, CFO

pressoffice@destinypharma.com

+44 (0)1273 704 440

SporeGen Limited

Professor Simon Cutting CEO

Kim Oanh Nguyen, COO

s.cutting@sporegen.com

+44-(0)7691 2090/+44-(0)7900 408043

Optimum Strategic Communications

Mary Clark, Shabnam Bashir, Manel Mateus

Tel: +44 (0) 203 174 1789

Email: DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)

Geoff Nash /Kate Bannatyne, Corporate Finance

Alice Lane, Corporate Broking

+44 (0)20 7220 0500

WG Partners (Joint Broker)

Nigel Barnes / Claes Spång / Nigel Birks

+44 (0) 203 705 9330

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines from its XF Platform that represent a new approach to the treatment of infectious disease. The company’s lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post-surgical hospital infections including MRSA. The XF drug candidates are being developed for the prevention and treatment of life-threatening infections caused by antibiotic‑resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

About SporeGen

SporeGen Limited was founded in 2012 as a biotech start up at the Royal Holloway University of London and was spun-out in 2017. The company is now situated at the London Bioscience Innovation Centre in central London. The company's focus has been on development of novel prophylactic and therapeutic products including vaccines. The company has worked extensively with spores (Bacillus/Clostridia) and were the first to use spores as vaccine delivery vehicles including coordination of a Phase 1 study of a mucosal vaccine. The company has licensed a number of interventions to companies including large global biotechnology companies. The company has a number of pipeline products including an oral vaccine to C. difficile infection that has been taken to phase 1 clinical studies. The company was founded by Professor Simon Cutting who is a leading expert in the bacteria Bacillus and its potential application as a medical treatment in human health.  Professor Cutting is a bacterial geneticist with over 35 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. After spending 7 years in the renowned laboratory of Professor Richard Losick at Harvard University Biological Laboratories (USA) he was as an Assistant Professor at the University of Pennsylvania Medical School in Philadelphia. He returned to the UK in 1996 where he is a Professor at the Royal Holloway, University of London. For further information please visit http://www.sporegen.com

About Innovate UK

Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. Innovate UK connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth.

Innovate UK fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions. Innovate UK is part of UK Research and Innovation. For more information visit www.innovateuk.ukri.org

UKRI Ideas to Address COVID-19

This UKRI (United Kingdom Research and Innovation) competition opened in March 2020 as a call for short-term projects addressing and mitigating the health, social, economic, cultural and environmental impacts of the COVID-19 outbreak across areas within UKRI's remit.