Interim results for the six months ended 30 June 2023

Destiny Pharma plc

(“Destiny Pharma” or the “Company”)

Interim results for the six months ended 30 June 2023

Active discussions with potential partners for XF-73 nasal supported by new market analysis that underscores $2bn market opportunity

Partnering deal with Sebela Pharmaceuticals for NTCD-M3 in North America fully funds phase 3 clinical development and commercialisation with significant upside potential

Appointments of Chris Tovey as Chief Executive Officer and Sir Nigel Rudd as Chairman add deal-making and commercial expertise to Board

Strengthened balance sheet gives cash runway into 2025, providing funding through significant value inflection points 

Brighton, United Kingdom – 20 September 2023 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development and commercialisation of novel medicines to prevent and treat life threatening infections, announces its unaudited interim financial results for the six months ended 30 June 2023 and provides an update for the year to date.

Operational highlights

• NTCD-M3 (prevention of C. difficile infection (“CDI”) recurrence)
• Partnering deal agreed with Sebela Pharmaceuticals in North America (US, Canada, and Mexico) worth up to $570m plus royalties
• Clinical development and commercialisation in North America financed by Sebela
• Preparations for Phase 3 clinical study underway, with current focus on optimising delivery of clinical trial product and CMC process development
• Peer reviewed paper published in Microbiology Spectrum concludes that NTCD-M3 is effective alongside all currently recommended antibiotics, including fidaxomicin, in the treatment of CDI

• XF-73 nasal (prevention of post-surgical staphylococcal hospital infections including MRSA)
• New survey of clinicians and payers in US and EU supports significant global market opportunity and underscores $2 billion market potential in US alone
• Active partnering discussions progressing with multiple interested global parties
• Landmark Phase 2b clinical data demonstrating primary endpoints were met published in leading US peer reviewed journal, Infection Control & Hospital Epidemiology
• Recent scientific advisory board (“SAB”) findings confirm proposed Phase 3 development pathway (post period) 

• Earlier stage pipeline
• US government’s National Institute, Allergy, and Infectious Diseases (NIAID) funding an extensive and on-going safety study of XF-73 dermal.  The second and final clinically-enabling regulatory study is expected to complete by late 2023
• Positive results from research into biotherapeutic treatment (SPOR-COV^®) for COVID-19 models supports potential as prophylactic nasal spray; partners reviewing options for development in light of current status of COVID-19 pandemic and current therapeutic options
• Results of a recent publication in Frontiers of Fungal Biology highlighted the potential of XF-70 and XF-73 as new drugs for the management of topical infections caused by Candida albicans (a common yeast infection) (post period)

• Strengthened Board and management team

• Board strengthened post period end with the appointments of Chris Tovey, CEO, and Sir Nigel Rudd, Chairman; Dr Debra Barker resumed her position as a Non-Executive Director and assumed the role of Senior Independent Director from 1 September

Financial highlights

·         $1million upfront payment received from Sebela during the period

·         Cash and short-term deposits at 30 June 2023 of £9.8 million (30 June 2022: £8.4 million; 31 December 2022: £4.9 million)

·         Expenditure on R&D in the period of £1.9 million (half-year 2022: £2.5 million; full year 2022: £4.9 million)

·         Company funded through to Q1 2025 following £7.3 million (gross) fundraise in Q1

Chris Tovey, Chief Executive Officer of Destiny Pharma, commented:

“I am delighted to present my inaugural update as CEO of Destiny Pharma. Destiny’s mission is to reduce the emergence and impact of drug resistant pathogens with preventative solutions. In my brief tenure to date I have been impressed by both the Company’s pursuit of this mission and the science behind it, which has shown its extraordinary ability to minimise the chances of bacteria becoming resistant and is backed by compelling clinical data.

“The partnering of NTCD-M3 and the associated fundraising during the period demonstrate our ability to generate significant value from our assets, and have positioned the Company for success as we advance the Phase 3 development programme for M3 and intensify our partnering activities for our lead asset, XF-73 nasal. The Company is now funded through to Q1 2025, allowing us to deliver our planned activities.

“Destiny Pharma has a unique opportunity to make a difference, and will play an important role in protecting vulnerable patients from potential lethal infections. Working with the Board and the leadership team, I am excited about what we can achieve.”

Destiny Pharma will be hosting a presentation to all existing and potential shareholders at 11.00am BST held via the Investor Meet Company platform.

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.

For further information, please contact:

Destiny Pharma plc

Chris Tovey, CEO

Shaun Claydon, CFO

+44 (0) 127 370 4440

pressoffice@destinypharma.com