Destiny Pharma plc Audited results for the year ended 31 December 2022

Destiny Pharma plc

 

("Destiny Pharma" or "the Company")

 

Audited results for the year ended 31 December 2022

 

Exclusive North American partnering deal worth up to $570m plus royalties secured for NTCD-M3

 

Phase 3 development plans finalised for XF-73 nasal following scientific advice from FDA and EMA

 

XF-73 dermal commenced clinically enabling safety study sponsored by US Government’s NIAID

 

New XF research projects initiated in cystic fibrosis and oral mucositis

 

Leadership strengthened with appointment of Chief Medical Officer and two Non-Executive Directors

 

    Balance sheet strengthened through £7.3 million fundraise post period end

 

Brighton, United Kingdom – 13 April 2023 – 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 2022.

Financial highlights

 

·       Loss before tax of £7.7 million (2021: £6.3 million)

·       R&D expenditure of £4.9 million (2021: £3.7 million)

·       Other operating expenses (excluding share based payment charge) of £2.5 million (2021: £2.3 million)

·       £6.5 million gross proceeds from Q1 2022 equity fundraise

·       Year-end cash and cash equivalents of £4.9 million (2021: £4.6 million)

·       Post period equity fundraise of £7.3 million (gross)

·       Cash runway extended to H2 2024

 

Operational highlights

 

NTCD-M3 for prevention of C. difficile infection recurrence

 

·      Continued progress made on preparations for the Phase 3 clinical trial of NTCD-M3, including CMC manufacturing scale up and regulatory clarity on Phase 3 clinical development plans.  

 

·      Positive scientific advice received from European Medicines Agency (“EMA”) on proposed Phase 3 study design.

 

·      US and European market research confirms substantial market opportunity for NTCD-M3. US market potential also validated by Sebela partnering deal announced in March 2023.

 

·      Results from US research support the use of NTCD-M3 following all commonly used antibiotic treatments.

 

·      Positive new data published on the absence of toxic gene transfer to NTCD-M3 in the peer-reviewed journal, Public Library of Science One (“PLOS ONE”).

 

XF-73 nasal gel for prevention of post-surgical infections

 

·      US Food and Drug Administration (FDA) has clarified Phase 3 and US registration pathway for XF-73 nasal gel for the prevention of post-surgical staphylococcal infections.

·      EMA feedback on XF-73 nasal gel Phase 3 programme identifies a clear route through European approval as a novel hospital infection prevention product.

 

·      Global Phase 3 study design finalised following discussions with regulators and key opinion leaders.

 

·      External European market research reports show that XF-73 nasal gel is seen as a very promising alternative to mupirocin, the current standard of treatment, by both clinicians and payers. The study suggests XF-73 has the potential to replace the current standard of treatment as the preferred pre-surgical nasal decolonisation agent.

 

·      Destiny’s own market analysis, supported by independent, specialist market research, indicates that the global peak sales for XF-73 nasal in the US and Europe could be over $1billion.

 

·      Active partnering programme initiated and early discussions with potential partners commenced.

 

Earlier pipeline and research projects

 

·      SPOR-COV^TM, our collaboration with SporeGen to develop a novel nasal spray to prevent viral respiratory infections, including COVID-19 and influenza, has completed grant funded research work with next steps being discussed and publications planned.

 

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

 

·      Destiny's China partner, China Medical System Holdings Limited (“CMS”), is conducting pre-clinical work on their own XF-73 dermal programme.

 

·      XF-73 shown to enhance the activity of two antibacterial drugs with the potential to develop improved treatments for lethal lung infections and infected diabetic foot ulcers caused by antimicrobial resistant bacteria.

 

·      Secured funding from the Cystic Fibrosis Foundation for new XF research project.

 

·      Initiated new XF research project targeted at oral mucositis.

 

Post period highlights

 

·       Exclusive collaboration and co-development agreement for North American (US, Canada and Mexico) rights to NTCD-M3 signed with Sebela Pharmaceuticals® worth up to $570 million plus royalties. This partnership with Sebela will finance the future clinical development and commercialisation costs of NTCD-M3 in North America whilst the Company retains majority rights for Europe and Rest of World.  Initial collaboration work has commenced and is progressing well. 

 

·       Successful equity fund raise of £7.3 million (gross) to enable closing of Sebela partnering agreement, strengthen balance sheet and continue to progress NTCD-M3 and XF-73 nasal toward Phase 3 clinical studies.

 

·       Peer reviewed paper published in Microbiology Spectrum concludes that NTCD-M3 is able to effectively and fully colonise the gut following fidaxomicin administration, indicating that NTCD-M3 would be effective in patients receiving this antibiotic, as well as older antibiotics, such as vancomycin and metronidazole.

 

·       Landmark XF-73 nasal Phase 2b clinical data published in the leading US peer reviewed journal Infection Control & Hospital Epidemiology.

 

 

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:

 

"Destiny Pharma has made good progress in 2022 and in the first quarter of 2023. We recently completed our first major out-licensing deal for NTCD-M3 and successfully strengthened our balance sheet through a fundraise of £7.3 million (gross) in March 2023 which was supported by new and existing investors. This has extended our cash runway to H2 2024 and removed the significant overhang of Phase 3 clinical development costs for NTCD-M3, whilst providing for potential milestone payments, as NTCD-M3 is commercialised, of up to $570m as well as royalties. Our priority now is to continue seeking additional partners for our two late stage clinical assets and to bring forward the earlier stage research projects. There is an urgent global need for new, innovative infection prevention medicines and Destiny Pharma believes that our targeted and diversified pipeline meets this clinical need and has substantial commercial potential that will drive value generation in the future.”

 

Webcast

 

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 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
pressoffice@destinypharma.com