29 Apr 2020 – Audited results for the year ended 31 December 2019 and clinical development update

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Audited results for the year ended 31 December 2019 and clinical development update

Company funded through to Q4 2021

Patient recruitment for XF-73 Phase 2b trial temporarily paused due to COVID-19 pandemic

Brighton, United Kingdom – 29 April 2020 – Destiny Pharma (“the Company”; 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), announces its audited financial results for the year ended 31 December 2019.

Financial and corporate highlights

• Strong cash position with cash and term deposits at 31 December 2019 of £7.5 million (2018: £12.1 million)
• Increase in R&D expenditure to £3.8 million (2018: £3.5 million) due to planned clinical development costs
• Cash runway extended to Q4 2021 through careful management of operational activities
• Appointment of Debra Barker, M.D. as Non-Executive Director

Operational highlights

XF-73 for prevention of post-surgical infections

• Phase 2b commenced in April 2019, with 68 patients currently recruited out of a target of 200
  • Study currently paused due to impact of COVID-19

• Publication of positive Phase 1 results from an independent study in the Journal of Global Antimicrobial Resistance (Yendewa et al, 2019) concluded:
  • Application of a nasal gel formulation of XF-73 in healthy volunteers was safe, well-tolerated and generated minimal side effects
  • Treatment with XF-73 was also associated with a rapid reduction in nasal Staphylococcus aureus in all subjects

• “Non-irritant” classification awarded to XF-73 nasal gel following positive results from a Phase 1 safety clinical study examining the drug’s potential to cause irritation when administered topically
• Prototype XF-73 nasal gel pack for the final marketed product being developed to deliver an easy-to-use, single dose, nasal gel tube to enable precise delivery and reduce wastage

Earlier pipeline and research grants

• MedPharm collaboration signed to develop new XF drug formulations as treatments for dermal and ocular infections
• Good progress on research projects with Cardiff University, University of Southampton and Aston University examining XF drugs in established infection models for dermal, respiratory and biofilm related indications
• Award of fourth research grant in collaboration with Sheffield University in September 2019 examining selected XF drugs in bacterial and fungal ocular infection models

Post-period highlights

• New XF formulations developed with promising drug release profiles and scope for delivery of XF drugs designed to treat dermal and ocular infections

Impact of COVID-19
The COVID-19 pandemic has slowed recruitment in the Company’s lead Phase 2b clinical trial with XF-73 for the prevention of postsurgical infections. Destiny Pharma has also seen a slowdown in some of its grant funded research projects as staff and facilities follow government guidance although the business impact here is minimal. Destiny Pharma is complying with international governmental advice and requirements across its operations to prioritise safety with all employees able to continue working effectively from home with minimal disruption to day-to-day operations as a result of the Company’s existing virtual model. Through careful management of cash resources Destiny Pharma is currently able to manage the impact of the pandemic and is closely monitoring the situation.

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
“We made good progress in 2019 and were very pleased to start recruitment into our lead Phase 2b programme evaluating the potential of our lead product, XF-73, to prevent post-surgical infections. Unfortunately, the study is now effectively paused due to restrictions on performing non-COVID-19 related clinical trials during the pandemic. We are working hard to accelerate recruitment when these restrictions are lifted and look forward to completing this important Phase 2b study as soon as possible. The Company remains well-funded and through careful management of our cash resources we have funding through to Q4 2021.

“It has been widely reported that the treatment of many patients infected with COVID-19 has been significantly complicated by secondary bacterial infections that take hold and contribute to the mortality rate. This highlights yet again the need for new, safe and effective antimicrobial drugs. We continue to believe that our proprietary XF-platform is well-positioned to generate such products and remain very positive about the future of Destiny Pharma.”

This announcement has been released by Neil Clark, CEO, on behalf of the Company.

The full text of the announcement may be found here.