Destiny Pharma (DEST ), a clinical stage biotechnology company, announced this morning unaudited results for the 6 months ended 30 June 2022 (H1 2022).

Financial highlights

The company reported cash and short-term deposits of £8.4m on 30 June, an increase of 18.3% from £7.1m a year ago. Net assets stood at £10.7m on 30 June 2022, compared to £10.2m a year ago. 

Expenditure on R&D in the period amounted to £2.5m, compared to £2m a year ago, and £3.7m in the full year 2021.

Destiny Pharma is therefore fully funded through mid-2023.

NTCD-M3 treatment

Destiny Pharma is finalising preparation for a Phase III clinical trial of its NTCD-M3 treatment for the prevention C. difficile infection (CDI) recurrence. US and European market research confirm substantial market opportunity for NTCD-M3, the company said. It reported "good progress" on partner discussions to co-fund studies and lead commercialisation.

Yesterday, the company announced it had received positive feedback from the European Medicine Agency (EMA) on its NTCD-M3 Phase III development programme. The EMA agreed with overall comparability plans regarding a new easy-to-use capsule formulation of NTCD-M3, lifting requirements for human trials to demonstrate such comparability.

Additionally, the EMA agreed that the proposed single trial Phase III is sufficient for a Marketing Authorisation Application, removing the need for further trials. The EMA also removed the requirement of a thorough QT study for NTCD-M3.

XF-73 treatment

Destiny Pharma also reported progress on its XF-73 nasal treatment for the prevention of post-surgical infections. The US FDA has clarified Phase III and a US registration pathway for XF-73. The European Medicines Agency has also given good feedback on XF-73, identifying a clear route through European approval, Destiny Pharma said.

The company said that external European market research shows XF-73 as a very promising alternative to the current standard treatment, mupirocin. The study suggests XF-73 has the potential to replace mupirocin as the standard and preferred pre-surgical nasal decolonisation agent.

Earlier pipeline and research projects

Grant-funded work is almost complete on SPOR-COV, Destiny Pharma's collaboration with SporeGen, aimed to develop a novel nasal spray to prevent viral respiratory infections, including Covid-19 and influenza.

The company reported positive results on its XF-73 dermal safety study from a collaboration with the US government's NIAID. Meanwhile, China Medical System Holdings, Destiny's China partner, is conducting pre-clinical work on its own XF-73 dermal programme.

Pharma also secured funding from the Cystic Fibrosis Foundation for a new XF research project and has initiated another XF research project targeted at oral mucositis.

Neil Clark, CEO, summarised: "I am pleased with the progress made in the first half of 2022 in moving our two lead clinical assets, NTCD-M3 and XF-73 Nasal, towards Phase 3 trials. We have progressed partnering discussions in relation to NTCD-M3 and have advanced our US and European regulatory plans for both programmes. Additionally, Destiny Pharma also has a strong pre-clinical pipeline. We remain convinced that our products, once commercialised, will reduce the number of infections and improve outcomes for patients, and help reduce significant healthcare costs while serving large global markets.

I am confident we will make further significant progress during the remainder of 2022 and beyond with our clear focus on infection prevention and delivering value to shareholders."

View from Vox

Destiny Pharma's two late-stage clinical assets represent strong potential for future revenue as the market for infectious and respiratory disease prevention and treatment continues to grow. Both NTCD-M3 and XF-73 are supported by strong Phase II clinical data and address clear clinical needs with significant commercial opportunities per aforementioned research on US and European markets.

The company said its board was committed to taking these late-stage treatments through final Phase 3 clinical studies, expected to create significant value for shareholders in the near-term. To this end, US and European regulatory work is progressing at a fast pace.

Overall, Destiny Pharma is well-positioned to benefit from increased international support for the development of novel anti-infective drugs that address the issue of anti-microbial resistance. Covid-19 highlighted the global need for innovation on this front, which Destiny is delivering.

The company is positioned as an R&D specialist, offloading commercialisation to partners that may also help fund Phase III trials. Destiny reported good progress today on partnering discussions, seeking to finalise "as soon as possible".

Neil Clark and Shaun Claydon of Destiny Pharma discussed today's results on the Vox Markets podcast this morning. Click here for that conversation.

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