reports
- Andy Smith
Fundraising to bolster its positioning
Destiny have announced a conditional fundraising at 50p per share that includes a placing, subscription and Open Offer that could in total raise up to £7.0m. With the raised level of uncertainty in the markets and the ongoing partnering of Destiny’s two Phase 3-ready assets, the Board decided to proceed with the fundraising so as not to delay the activities on its two lead assets. Just as importantly, reinforcing its balance sheet should strengthen its negotiating position with potential partner...
- Andy Smith
Very welcome regulatory clarity
Destiny Pharma has announced details of positive feedback from the European Medicines Agency (EMA) on the proposed Phase 3 programme for one of its two Phase 3-ready products, XF-73 for the prevention of post-surgical staphylococcal infections: • the successful completion of the proposed Phase 3 clinical programme is expected to lead to the registration of XF-73 nasal gel in Europe. While the number of patients in the study and the number of separate trials in the programme have not been disc...
- Andy Smith
M3's profile rising further
In a spree of positive updates to start 2022, Destiny Pharma begins the year with the profile of anti-infectives continuing to rise after the recent Lancet publication, the advancing regulatory preparations on the Phase 3 studies of its two lead products, and partnership discussions all aligning. Destiny’s most recent announcement on the compatibility of M3 should increase its attractiveness to potential partners. The recent announcement of the preclinical studies conducted by the US Departmen...
- Andy Smith
Support on both fronts
Destiny’s most recently acquired Phase 3-ready product, the non-toxigenic Clostridioides difficile strain M3 (NTCD-M3), appears to be in the right place, at the right time. November is C.difficile awareness month and Destiny’s consultant and Advisory Board member Professor Dale Gerding has just presented at the C.difficile International Conference. We have collated data on these recent presentations, and results from competitors to Destiny Pharma’s NTCD-M3 product for the prevention of recurre...
- Andy Smith
New dermal collaboration on XF-73
Destiny Pharma has announced a new clinical programme that is planned to start in China, led by its existing partner China Medical Systems Limited (CMS). Destiny already has an earlier stage (than its two Phase 3-ready programmes) dermal programme on XF-73, but for serious infections of burns and open wounds. This new programme is to be run by CMS for the larger market of the prevention and treatment of superficial bacterial skin infections. While investors may have forgotten CMS’s involvement...
- Andy Smith
H1 2021 Interims: still on track
Destiny's interim H1 2021 financial results were an upbeat and extensive update on the clinical trial progress achieved in the period. There were no surprises in the financials and progress towards starting the Phase 3 studies continues. The first of these should be the NTCD-M3 study in H2 2022, subject to financing. A range of funding options are under evaluation for the progression of Destiny’s two Phase 3-ready assets. While the positive progress has been detailed in our recent notes on X...
- Andy Smith
XF-73 data maturing, like a fine wine
Destiny have released additional endpoint analyses after the positive headline announcement of the Phase 2b study of XF-73 for the prevention of staphylococcal post-surgical infections in March 2021. The new analyses looked at the same endpoint, but out to six days after surgery and confirmed the durability of XF-73’s effect on S.aureus carriage. The recent analysis of the secondary endpoints at later timepoints improved XF-73’s profile even further. This data showed that XF-73-treated patient...
- Andy Smith
A glaring differential in validation
Recent transactions and the introduction of a new Act of the US Congress are further advancing the narratives on both the microbiome and new antimicrobials. These are the two areas where Destiny Pharma is focussed. Deals in the anti-infective space highlight the discrepancy between US and UK valuations for these assets, and it can only be a matter of time before Destiny, with its late-stage assets with better competitive profiles, becomes involved. We have left our financial forecasts and valua...
- Andy Smith
Encouraging AGM and M3 updates
Destiny’s recent announcement on the progress on its lead asset NTCD-M3 maintains the momentum that has built since the acquisition of M3 in 2020. In addition, while the AGM narrative did not promise a licensing transaction on either of Destiny’s Phase 3-ready assets, the timelines for partnerships in 2021 and the Phase 3 studies starting in 2022 remain intact. Destiny also welcomes the recent G7 Health Ministers’ Meeting communique on 4 June and its strong message highlighting the global thre...
- Andy Smith
M3: Another gem in the portfolio
With the recent announcement of the positive Phase 2b clinical study of XF-73 in the prevention of post-surgical staphylococcal infections, Destiny has become a rare UK biotech company owning two Phase 3-ready assets. Yet NTCD-M3 may have been forgotten by investors with the excitement surrounding the positive clinical trial announcement. Destiny acquired the worldwide rights to the non-toxigenic Clostridioides difficile strain M3 (NTCD-M3) for the prevention of C.difficile infections (CDIs) i...
- Andy Smith
What a difference a year makes
Destiny has transformed its position, both in fundamental terms and in share price strength. A year ago, the group was navigating the conduct of its Phase 2b clinical trial through the challenges of the pandemic. 12 months on, positive results from that study, the acquisition of another Phase 3-ready program, plus a successful fundraising have all reshaped Destiny’s investment proposition. The costs and news flow of Destiny’s US Phase 2b study rightly dominated its FY 2020 financial results. O...
- Andy Smith
The best possible scenario
Destiny has announced the top-line results of its Phase 2b clinical study of XF-73 in the prevention of staphylococcal post-surgical infection. As an active antimicrobial agent, we had expected XF-73 to have efficacy in this indication, but the strength of the data was an outstanding result. Specifically, there was a greater than 99% reduction in nasal carriage achieved in just 24 hours, the primary endpoint of the study, compared to placebo. Destiny is now in the attractive but unusual situat...
- Andy Smith
2021 starts well with XF-73 study fully recruited
Destiny has announced that the patient recruitment for its Phase 2b study, conducted under a US IND, is complete and that they are on-track to report top-line results for this study before the end of Q1 2021. Their internally developed product XF-73, for the prevention of post-surgical Staphylococcal infections, has completed the target recruitment of 125 patients scheduled for open heart surgery. Destiny also recently announced progress on the recently-acquired Phase 3-ready asset non-toxi...
- Andy Smith
A group transformed
While completing the Phase 2b study of their first product, Destiny have announced the planned acquisition of an exciting late-stage preventative product and a fundraising to support its Phase 3 development. Along with the previously announced agreement with SporeGen on the preventative therapy for COVID-19, Destiny’s portfolio is being transformed by its business development spurt. The acquisition of the global rights to non-toxigenic Clostridiodes difficile strain M3 would catapult Destiny’s...
- Andy Smith
Plenty of progress in H1
Having navigated the challenge of running a clinical trial during a global pandemic, Destiny has blossomed in mid-2020. It is on track to announce top-line Phase 2b results for XF-73 in the prevention of post-surgical infections in Q1 2021. It has also expanded its pipeline to span the two most contemporary issues in biotech: the microbiome and the prevention of COVID-19 infections. Cash at the end of H1 2020 was £5.6m (£9.1m at the end of H1 2019) and in-line with our estimates. The compan...
- Andy Smith
Another string to Destiny's bow
Destiny Pharma have always had a microbiome tilt with their most advanced product, topical XF-73, being developed for the prevention of post-operative infections. But now, with a new collaboration and grant award for the SPOR-COV program, they have taken this even further to encompass the two hot-button issues in anti-infectives: the microbiome and coronavirus infections. Now Destiny’s discovery efforts and pipeline have been expanded with the SPOR-COV collaboration and grant award with Spor...
- Andy Smith
New Model Anti-infectives
Destiny Pharma is not just developing novel anti-infective drugs - its lead product XF-73 is in the US and European Phase 2b study for a new preventative indication that had not been awarded to any other drug before. The clinical study of XF-73, which has proven antimicrobial activity, is expected to report an interim review in August 2020. As anti-infectives have higher probabilities of success than other therapeutic areas, Destiny’s destiny looks bright. Many august healthcare organisati...
- Andy Smith
Differentiated anti-infectives
Destiny Pharma’s FY 2019 results featured its ongoing Phase IIb study of its lead drug XF-73 for the prevention of post-operative staphylococcal infections and its prudent cash management. Careful financial management had decreased Destiny’s operating loss to £5.6m (vs. £6.1m in FY 2018) of which, R&D costs were £3.8m (£3.5m in FY 2018). The coronavirus pandemic has brought swings and roundabouts for Destiny – a pause to the Phase IIb study and therefore a delay in licensing the prod...
- Andy Smith
Differentiated anti-infectives
Following the set of largely established US and EU guidelines which recommend the decolonisation of patients’ noses of Staphylococcus aureus before surgery to prevent subsequent surgical site infections, Destiny recently reported the new Asia Pacific Society of Infection Control (APSIC) guidelines that are now harmonised with the US and EU positions. This is important for Destiny’s first product – XF-73 which is currently in a US Phase IIb study for the prevention of post-surgical staphylo...
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