Destiny Pharma plc
(“Destiny Pharma” or “the Company”)
Audited results for the year ended 31 December 2021
Good progress preparing NTCD-M3 Phase 3 programme targeting C. difficile infection recurrence
Discussions continue to progress with potential licensing partners for NTCD-M3
Primary endpoint met in XF-73 nasal Phase 2b clinical study
Secondary endpoint data showed XF-73 nasal exhibited a significant and sustained nasal reduction of S.aureus
Positive feedback from European Medicines Agency on XF-73 nasal Phase 3 programme design
£6.5M post period equity fundraise completed – Company funded through to mid-2023
Brighton, United Kingdom – 12 April 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, announces its audited financial results for the year ended 31 December 2021.
Financial and corporate highlights
- Loss before tax of £6.3 million (2020: £6.5 million)
- R&D expendiure of £3.7 million (2020: £4.5 million)
- Other operating expenses (excluding share based payment charge) of £2.3 million (2020: £1.9 million)
- Year-end cash and cash equivalents of £4.6 million (2020: £9.7 million)
- Post period equity fund raise of £6.5 million
- Cash runway extended to mid-2023
NTCD-M3 for prevention of C. difficile infection recurrence
- Good progress made during the year with the transfer and commencement of manufacturing scale up processes and advancement of discussions with US and European regulators on finalising the detail of the Phase 3 clinical trial design. Regulatory discussions are expected to conclude in the first half of 2022, manufacturing scale up by year-end and the Phase 3 trial is targeted to commence thereafter.
- Discussions are progressing with potential licencing partners, with several parties active in the data room. This is in line with the Company’s strategy of seeking partners to co-fund Phase 3 trials and lead commercialisation of the asset.
- US Department of Veterans Affairs research study confirms the potential of NTCD-M3 as a novel treatment to prevent the recurrence of C. difficile infections (CDI) that can be used alongside all standard-of-care antibiotic treatments.
- US and European market research underpins clinical support and market potential of NTCD-M3.
- Establishment of a NTCD-M3 clinical advisory board consisting of Professor Dale Gerding MD, US, who discovered NTCD-M3, Professor Mark Wilcox MD, UK key opinion leader in CDI and other medical and drug development experts with recent experience of running and designing international Phase 3 clinical studies in CDI.
XF-73 nasal gel for prevention of post-surgical infections
- Positive top-line results in Phase 2b clinical study reported in 2021. Primary efficacy endpoint met successfully with high statistical significance and no treatment related safety events.
- Very good secondary endpoint data announced in August 2021 showed that XF-73 has the potential to keep patients at a significantly low aureusnasal burden during the period of highest infection risk which runs from 1 hour prior to incision, during surgery itself, to the start of wound healing and out to 6 days post-surgery.
- Independent European report underpins the clinical need and market opportunity of XF-73 nasal gel which is seen as a very promising alternative to the current standard of care, Mupirocin, by both clinicians and payers.
- Successful XF-73 nasal gel Phase 2b study data was presented at 2021 ECCMID (European Congress of Clinical Microbiology & Infectious Diseases) Congress by infection prevention expert, Professor Julie Mangino MD.
Earlier pipeline and research projects
- Two new collaborations signed: NIAID in US supporting XF-73 dermal infection programme and US Department of Veterans Affairs to research NTCD-M3 for prevention of recurrence of CDI.
- Pre-clinical work on SporCov COVID-19 programme in collaboration with joint partner SporGen Limited (which is largely funded by an £0.8 million Innovate UK grant) completing in H1 2022. Plans for next stage of development are being progressed.
- XF platform research projects are progressing well after Covid-19 delays and are largely funded by grants and non-dilutive funding.
Post period highlights
- Positive feedback received from the European Medicines Agency (EMA) on plans for XF-73 nasal gel Phase 3 programme design. Phase 3 can use a similar primary endpoint to the successful Phase 2b clinical study, providing a route through Phase 3 trials to the European approval of XF-73 nasal gel as a ground breaking hospital infection prevention product. Feedback from FDA is expected in Q2 2022.
- Successful completion of the first of two pre-clinical safety studies of XF-73 Dermal formulation. Work continues with US Government’s NIAID to complete preclinical safety package that will support future clinical development of XF-73 Dermal in serious wound infections.
- China Medical System Holdings Limited (CMS), the Company’s China regional partner and investor, started an additional dermal programme with XF-73 targeting the prevention and treatment of superficial skin infections caused by bacteria.
- Successful equity fund raise of £6.5 million (gross) to enable continued progress of NTCD-M3 and XF73 nasal toward Phase 3 clinical studies, finalisation of regulatory plans and strengthening of balance sheet.
Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
“With full control of two high quality, late-stage clinical assets targeted at infection prevention, both of which are backed by strong Phase 2 clinical data and clear commercial positioning, Destiny Pharma is very well positioned for the future. We have made excellent progress in developing our pipeline in 2021 and the Board and employees are excited about delivering on our strategy to build a world leading infection prevention company.”
Destiny Pharma will host a webcast presentation followed by a live Q&A session at 10:30 am BST today, accessible via the Investor Meet Company platform.
The webcast of the presentation will be available on the Company’s investor relations website at www.destinypharma.com. The presentation is open to analysts and all existing and potential new shareholders.
Investors can sign up to Investor Meet Company for free, and add to meet Destiny Pharma plc via:
https://www.investormeetcompany.com/destiny-pharma-plc/register-investor. Investors who already follow Destiny Pharma plc on the Investor Meet Company platform will automatically be invited.
This announcement has been released by Shaun Claydon, Chief Financial Officer (CFO), on behalf of the Company.
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
Optimum Strategic Communications
Mary Clark / Manel Mateus / Vici Rabbetts
+44 (0) 208 078 4357
finnCap Ltd (Nominated Advisor and Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0) 207 220 0500
MC Services AG
Anne Hennecke / Andreas Burckhardt
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 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
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.
The full text of the announcement may be found here.