Destiny Pharma reports strong FY23 performance, explores options for XF-73 Phase 3 trials
() , a clinical stage biotechnology company, updated markets on trading for the year ended December 31, 2023 (FY23), and licensing discussions for its XF-73 Nasal candidate aimed at preventing post-surgical infections.
Destiny narrowed its loss before tax to £6.4m from £7.7m in FY22. R&D expenditure was £3.3m from £4.9m LY, and other operating expenses came in at £3.8m, up from £2.5m in FY22. Year-end cash and cash eq rose to £6.4m from £4.9m at the end of 2022. Total liabilities narrowed to £0.8m from £1.2m, primarily due to lower accrued development costs at year-end.
Operationally, said it is developing a new clinical trial design based on feedback for its XF-73 Nasal candidate aimed at preventing post-surgical infections. The new model is expected to halve estimated Phase 3 trial costs. Based on positive commercial feedback, positive study data, and Phase 2b clinical data published in a US peer-review journal, confirmed "significant commercial potential" for XF-73 and a US go-to-market model.
These milestones have helped Destiny engage potential partners regarding a licensing deal for XF-73 Nasal. The company said discussions are ongoing alongside a review of "strategic options" to support the asset's advancement through Phase 3 clinical trials. These broadly include licensing and fundraising options, but not an offer for the company.
Regarding its NTCD-M3 candidate for the prevention of Clostridioides difficile infection (CDI) recurrence, Destiny signed a partnering deal with Sebela Pharmaceuticals covering North America, worth up to $570m plus royalties. Sebela will be responsible for financing all remaining clinical development and North America commercialisation.
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A number of key milestones achieved in FY23 and post-period underline the value of Destiny Pharma's lead XF-73 and NTCD-M3 assets. Positive data from early studies and Phase 2 trials for both candidates was published in a number of leading US-based peer review journals, establishing strong commercial metrics. XF-73 can be particularly disruptive as a powerful alternative to antibiotics in the prevention of surgical site infections.
Destiny has widened its range of possible commercial paths for XF-73, exploring licensing and fundraising options in addition to earlier initiated partnership talks. Destiny has used its positive early data to design a Phase 3 strategy that halves previous cost estimates, and a go-to-market strategy that should help attract further interest. Fundraising is also being considered in parallel. did not divulge specifics and it is too early to assess how licensing efforts will develop, but based on the asset's proven effectiveness so far and sheer size of unmet medical demand it targets, there is good reason to remain optimistic.
The addressable market for NTCD-M3 is also significant with CDI being the most common type of infection caused by antibiotic use. The agreement with Sebela, worth up to US$570m, significantly derisks the development and commercialisation of NTCD-M3 while removing the need for Destiny to further invest in the asset. Development is advancing at pace, with Sebela planning a further Phase 2 study following market research confirming commercial preference for a solid dose oral formulation.
's two lead assets have both successfully completed Phase 2 trials and have shown to be effective and well tolerated. Both address clear clinical needs and present strong potential for future revenue as the market for infectious and respiratory disease prevention and treatment continues to grow. With a comfortable year-end cash balance of £6.4m, is funded through to Q1 2025, allowing it to deliver on its current planned activities.
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