Destiny Pharma. Regulatory News (DEST)

Destiny Pharma plc

("Destiny Pharma" or "the Company")

XF-73 Dermal infection project advances into clinically enabling safety study as part of ongoing agreement with US Government's NIAID

Brighton, United Kingdom, 15th November 2022 - Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, is pleased to announce the commencement of an Investigational New Drug (IND) enabling safety study with its novel XF-73 Dermal formulation.

This study is the second of two planned preclinical safety studies of the XF-73 Dermal formulation and will utilise a suite of preclinical services for interventional agent assessment (Contract No. HHSN272201800001I/75N93023F00001) held by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). The first study met its objectives and generated positive data as announced in February 2022. Following a US Food and Drug Administration (FDA) review of the first study, Destiny Pharma has completed further work developing both the dermal formulation and potential regulatory and clinical plans, which has cleared the path for progression into this second and final preclinical safety study.

Destiny Pharma is developing the novel formulation of XF-73 Dermal for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers (DFUs) - up to 25% of US diabetic patients may suffer from DFUs in their lifetime and c. 13% have active ulcers. The XF-73 Dermal product is planned to be a fast, cost-effective dermal treatment that kills all relevant bacteria quickly, helping the wound heal and combatting the threat of Antimicrobial Resistance (AMR) through its novel, patented action.

Destiny Pharma will continue to work with NIAID to complete this preclinical safety package which will support future clinical development of XF-73 Dermal in serious wound infections. The study is planned to complete in Q2 2023 and should then be ready to move into clinical trials.

Neil Clark, CEO of Destiny Pharma, said: "We are very pleased with the continuing progress of our novel XF-73 Dermal infection programme which is targeted at meeting a clear clinical need driven by the increasing incidence of diabetes across the world. There are 29 million people diagnosed in the United States alone who are at risk of developing diabetic foot ulcer infections and peak product sales could reach half a billion US dollars. The start of this second preclinical study means that this programme is well placed to deliver a second clinical candidate in 2023 from our XF platform following the excellent Phase 2 clinical results generated for the XF-73 Nasal gel for the prevention of post-surgical infections caused by Staphylococcal aureus."

For further information, please contact:

Destiny Pharma plc

Neil Clark, CEO

Shaun Claydon, CFO

pressoffice@destinypharma.com

+44 (0)1273 704 440

Optimum Strategic Communications

Nick Bastin, Manel Mateus, Eleanor Cooper

DestinyPharma@optimumcomms.com

+44 20 3922 0891

finnCap Ltd (Nominated Advisor and Broker) Geoff Nash / Abigail Kelly / George Dollemore, Corporate FinanceAlice Lane / Nigel Birks / Harriet Ward, ECM+44 (0) 207 220 0500

MC Associates AG

Anne Hennecke / Andreas Burckhardt

+49-211-529252-0

Stern IR - US

Janhavi Mohite

+1-212-362-1200

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV™, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information, please visit www.destinypharma.com  

About XF-73

XF-73 is the lead drug candidate from Destiny Pharma's XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. XF‑73 has been awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the US FDA.

Dermal Infections

XF-73 is being developed as a new treatment for serious dermal infections such as diabetic foot ulcer infections (DFUs) to target a market which is estimated to be a $0.5 billion global sales opportunity based on the incidence of such infections, the costs of the associated medical care and a realistic product pricing of XF-73 in this new market. Driven by the growing number of diabetics and associated complications such as infected DFUs, this represents a significant market opportunity for XF-73. It is estimated that twenty-nine million people in US have a diagnosis of diabetes and of these 13% have active DFUs.

As with all anti-infectives, AMR is also a concern within this market. There is no dominant treatment for DFUs, and specialist physicians are therefore working to find better treatment options, including topical formulations. In addition, the target product profile of XF-73 tested favourably with dermal clinicians looking for better treatments for the smaller market for burns/wound infections and venous leg ulcers.

Destiny's China partner CMS is also running a programme for XF-73 in superficial skin infections.

Forward-looking statements

Certain information contained in this announcement, including any information as to the Group's strategy, plans or future financial or operating performance, constitutes "forward-looking statements". These forward looking statements may be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "projects", "expects", "intends", "aims", "plans", "predicts", "may", "will", "seeks" "could" "targets" "assumes" "positioned" or "should" or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group's results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group's control. Forward looking statements are not guarantees of future performance. Even if the Group's actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.