Brighton, United Kingdom - 23 September 2019 - Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs that address clear commercial opportunities and also address the global problem of anti-microbial resistance (AMR), announces its unaudited financial results for the half-year ended 30 June 2019 and an update for the year to date.
· Strong cash position with cash and term deposits at 30 June 2019 of £9.1 million (30 June 2018: £15.1 million; 31 December 2018: £12.1 million)
· Expenditure on R&D in the period of £1.7 million (half-year 2018: £1.3 million; full year 2018: £3.5 million) reflecting the increased investment in clinical programmes as described below
· Company funded through to 2021
Phase 2b clinical trial: XF-73 nasal gel for prevention of post-surgical infections
· XF-73 (exeporfinium chloride) nasal gel Phase 2b trial has started enrolling 200 surgical patients in sites in the US and Europe
· European site set-up on schedule but US sites slower than expected. Consequently, recruitment expected to complete in early 2020 with results announced later in mid-2020 (previously recruitment was planned to end in Q4 2019)
· Interim safety, efficacy and futility analysis of Phase 2b trial, performed by independent safety monitoring board, planned for end of 2019
· Prototype XF-73 nasal gel pack for the final marketed product is being developed to deliver an easy-to-use, single dose, nasal gel tube to enable precise delivery and reduce wastage
· "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. This classification supports lead nasal programme and use in Phase 1 dermal infection project
Earlier pipeline and research projects
· MedPharm collaboration signed to develop new XF drug formulations as treatments for dermal and ocular infections
· Award of UK China AMR grant of up to £1.6 million to examine XF drugs potential against dermal and ocular infections
· Research projects with Cardiff, Southampton and Aston Universities making good progress examining XF Drugs in established infection models for dermal, respiratory, ocular and biofilm related indications
Governmental initiatives supporting development and commercialisation of novel anti-infectives
· UK government announced new 5 and 20 year plans to address anti-microbial resistance (AMR) including support for novel drug development and financial incentives for companies bringing such drugs to market.
· The NHS is testing the world's first 'subscription' style payment model to incentivise pharmaceutical companies to develop new drugs for resistant infections
· US government announced a healthcare reform for novel antibacterial drug payments, including an alternative pathway for new technology add-on payments (NTAPs), which increases the value of these payments to 75% for Qualified Infectious Disease Products (QIDPs): XF-73 has QIDP status.
· Award of fourth research grant in collaboration with Sheffield University examining selected XF drugs in bacterial and fungal ocular infection models
Neil Clark, CEO of Destiny Pharma, commented:
"Destiny Pharma has made good progress in the first half of the year and we are very pleased to have started recruitment of patients into the important Phase 2b study of our lead drug candidate, XF-73, for the prevention of post-surgical hospital infections. This is a major milestone for the Company and we look forward to reporting results in mid-2020 with patient recruitment planned to complete in Q1 2020.
We remain very positive on the clinical need and commercial opportunity for XF-73 in the hospital setting which we estimate in the US alone to be peak annual product sales of $1 billion. Our discussions with potential US hospital clinical trial sites and new, independent US studies confirm the increase in the decolonisation of nasal carriers of Staphylococcal aureus in the US as "best practice" ahead of major surgeries.
Whilst our focus remains on our lead indication, we are also progressing our earlier pipeline to realise further value from the XF drug platform and we look forward to producing new data from these programmes in the next 12 months. Our successes in securing grant funding also helps offset net cash outflows and the Company is funded into 2021.
We continue to believe that Destiny Pharma's novel XF platform has the potential to deliver new anti-microbial drugs for clearly defined commercial opportunities that tackle serious infections. These are increasingly caused by superbugs and our platform has significant potential in the fight against the global rise of anti-microbial resistance."