Destiny Pharma. Regulatory News (DEST)

Destiny Pharma plc

("Destiny Pharma" or "the Company")

Positive results in XF-73 Dermal safety study from ongoing agreement with US Government's NIAID

Brighton, United Kingdom, 1 February 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, today announces the successful completion of a preclinical safety study with a novel XF-73 dermal formulation.

The study was the first of two preclinical safety studies of its lead XF-73 Dermal formulation carried out as part of a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health. The study met its objectives and generated positive data, which clears the path for its progression into the second and final clinically‑enabling regulatory safety study. Both studies are being conducted through NIAID's suite of preclinical services.

Destiny Pharma is developing a novel formulation of XF-73 (XF-73 Dermal) for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers.

Destiny Pharma will continue to work with NIAID to complete this preclinical safety package that will support future clinical development of XF-73 Dermal in serious wound infections. The study is planned to complete in 2022.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: "We are very pleased with the encouraging data from our novel XF-73 dermal formulation which is aimed at meeting a clear clinical need in a large market where peak product sales could reach half a billion US dollars. This programme is well placed to deliver a second clinical candidate 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

Mary Clark, Manel Mateus, Vici Rabbetts

DestinyPharma@optimumcomms.com 

+44 (0) 208 078 4357

www.optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)

Geoff Nash / Kate Bannatyne, Corporate Finance

Alice Lane, Corporate Broking

+44 (0) 207 220 0500

MC Services AG

Anne Hennecke / Andreas Burckhardt

+49-211-529252-0

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 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. 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.