Annuncio • Aug 14
Destiny Pharma Initiates Research to Explore XF Drug Potential for CF Destiny Pharma announced the initiation of a research project to test a potential treatment for people with cystic fibrosis. This programme, supported in part by the U.S. Cystic Fibrosis Foundation, will evaluate the potency of XF platform drugs against a range of contemporary clinical isolates of the bacterial superbug Methicillin-resistant Staphylococcusaureus (MRSA) collected from the lungs of people with cystic fibrosis (CF) in the United States. Destiny Pharma is providing the Company's proprietary XF-73 drug to the CF Foundation National Resource Center for Microbiology at the Seattle Children's Hospital. The studies will involve: Measuring the potency of XF-73 against 33 contemporary MRSA isolates from people with CF, The impact of mucus, which protects MRSA from traditional antibiotic treatment, on the activity of XF-73 will also be evaluated. CF is a progressive, genetic disease that affects the lungs, pancreas, and other organs. There are nearly 40,0001 children and adults living with CF in the United States and an estimated 105,000 people have been diagnosed with CF across 94 countries, with a further 35% estimated to be undiagnosed2. People with CF have a dysfunctional cell membrane protein, which causes the overproduction of thick and sticky mucus. The mucus clogs airways in the lungs and traps bacteria, leading to infection, respiratory failure, and other complications. MRSA infections are much higher in people with CF than in the general population. It is now found in more than 15% of people with the disease. MRSA is resistant to multiple antibiotics, and lung infections caused by the bacteria often become long-term. The work investigating the utility of XF-73 against MRSA in CF follows on from recent peer-reviewed publications demonstrating that XF-73 has superior activity compared to mupirocin against MRSA isolates in a superficial skin infection model3; and that XF-73 has activity against 840 MRSA clinical isolates from patient infections from around the world4. Further data on the ability of XF-73 to prevent bacterial invasion of the bloodstream by MRSA in an in vivo burn wound model is to be presented at this year'sInfection Prevention Society Conference. Annuncio • Aug 12
Destiny Pharma plc Announces Last Day of Dealings on AIM Destiny Pharma plc reminded shareholders that the last day of trading in Destiny Pharma's ordinary shares on AIM is 12 August 2024. The cancellation of the admission of the Company's ordinary shares to trading on AIM (the "Cancellation") was originally announced on 15 July 2024 and was approved by shareholders at the general meeting held on 31 July 2024. The Cancellation will become effective at 7:00 a.m. on 13 August 2024. Following Cancellation, the Company will re-register as a private company under the name Destiny Pharma Limited. Annuncio • Jul 23
Destiny Pharma plc Announces New Clinical Data from its Phase 2b Clinical Trial on XF-73 in Cardiovascular Surgery Patients Destiny Pharma announced that new clinical data from its Phase 2b clinical trial on XF-73 in cardiac surgery patients has been accepted for presentation at the ID Week conference, the joint annual meeting of the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America on the 16-19 October 2024 in Los Angeles, USA. Further planned data analysis of a secondary endpoint within the clinical trial investigated the use by physicians of post-surgical systemic antibiotics prescribed >48 hours after surgery. Significantly fewer patients in the XF-73 treatment arm received post-operative anti-staphylococcal antibiotics: 46.5% (20 of a total population of 43), compared to 70% (28 of a total population of 40) in the placebo group, p=0.045, which suggests that antibiotics may have been prescribed as an early intervention in more patients in the placebo arm. The observed reduction of the use of post-operative antibiotics in the XF-73 arm is consistent with the principles of good antimicrobial stewardship which are crucial for managing and preventing infections more effectively and for maintaining the efficacy of antibiotics, reducing healthcare complications, and improving patient safety. Additional advantages of the XF-73 Nasal gel include the short, 24 hour, pre-surgical dosing regimen, rapidity of S. aureus nasal decolonisation, remote likelihood of resistance emergence, and the duration of effect. These features provide a good fit with clinical practice, potentially enabling infection risk reduction peri-operatively, enhancing flexibility for scheduling surgeries, and augmenting antibiotic stewardship efforts. Phase 3 studies are being planned to evaluate and gain regulatory approval for XF-73. XF-73 has also demonstrated efficacy against the hospital superbug methicillin-resistant Staphylococcus aureus (MRSA). In studies published last year XF-73 was potent against all 840 MRSA strains collected from infected patients from 33 countries worldwide (Rhys Williams et al. 2023)2 and was shown to be up to 1000 times more efficacious than nasal mupirocin (the most commonly used nasal antibiotic) at treating MRSA in a skin infection model, (Zhang et al. 2023). New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -UK£5.6m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£5.6m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (UK£8.0m net loss in 2 years). Revenue is less than US$5m (UK£832k revenue, or US$1.1m). Market cap is less than US$100m (€9.89m market cap, or US$10.6m). Annuncio • Jun 13
Destiny Pharma plc Receives Innovation Passport Designation by the UK MHRA for XF-73 Nasal for the Prevention of Post-Surgical Site Infections Destiny Pharma plc announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) to XF-73 Nasal for the prevention of post-surgical site infections. ILAP is unique as it aims to accelerate the time to market and facilitate patient access to medicines in the UK for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. The pathway provides access to the MHRA and its partner agencies: the National Institute for Health and Care Excellence (NICE); NHS England; National Institute for Healthcare Research (NIHR); Health Research Authority (HRA); the Scottish Medicines Consortium (SMC); and the All Wales Therapeutic and Toxicology Centre (AWTTC); who facilitate clinical research activities and provide practical and regulatory support which fosters an innovative and unified relationship with regulatory authorities. The pathway actively incorporates the patient voice to help guide and accelerate drug development; and input from NICE leads to early discussions around market access, enabling pricing and reimbursement considerations to be factored in at an earlier stage. The MHRA ILAP Steering Committee noted that XF-73 Nasal is already at a late stage of development and has a well-developed Target Development Profile which can be developed through accessing the benefits offered by the ILAP toolkit which includes recommendations from the Patient Engagement Team; clinical trial application and guidance, alongside advice and Conditional Marketing Authorisation. The Company will now collaborate with ILAP to enable further development of its innovative clinical trial designs to ensure rapid patient access, through acceleration of time to market and early incorporation of key endpoints for reimbursement. XF-73 Nasal is a Phase 3 ready asset designed to prevent post-surgical infections occurring, including MRSA. Annuncio • May 12
Destiny Pharma plc, Annual General Meeting, Jun 12, 2024 Destiny Pharma plc, Annual General Meeting, Jun 12, 2024. Location: the offices of covington and burling llp, 22 bishopsgate, ec2n 4bq, london United Kingdom New Risk • Apr 25
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (14% average weekly change). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£5.7m net loss next year). Revenue is less than US$5m (UK£986k revenue, or US$1.2m). Market cap is less than US$100m (€23.9m market cap, or US$25.6m). Annuncio • Apr 08
Destiny Pharma plc to Report Fiscal Year 2023 Results on Apr 25, 2024 Destiny Pharma plc announced that they will report fiscal year 2023 results on Apr 25, 2024 Annuncio • Jan 31
Destiny Pharma plc Announces Clinical Development Update Positive Results from XF-73 Dermal Safety Study Destiny Pharma provides a clinical development update on two of its programmes. The Company announced positive data from a pivotal preclinical safety study of XF-73 Dermal, a novel dermal formulation for the treatment of antibiotic resistant skin infections associated with open wounds and broken skin. Conducted as part of a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID)1, the in vivo safety study met all endpoints. The study examined the potential toxicity of XF-73 Dermal following one, two and three doses of XF-73 Dermal applied to broken skin and wounds weekly for up to five weeks. The product was well tolerated with no significant impact on any clinical or safety parameters and had no apparent negative impact on wound healing. Importantly, XF-73 was retained locally at the site of wound application with negligible amounts seen in the bloodstream, further supporting the safety profile of this product. Subject to regulatory approval, these positive safety results enable the progression of XF-73 Dermal into clinical studies for evaluation in a wide range of serious infected skin and wound conditions. Following this positive study outcome, Destiny Pharma intends initially to progress XF-73 Dermal towards clinical evaluation for the treatment of Diabetic Foot Infections (DFI) and serious burn wound infections, two areas with a clear unmet need and large patient populations. The Company is confident in the potential positive impact that XF-73 Dermal can provide in these settings and will now explore the most appropriate route to move the product forward in these indications. In line with plans disclosed at the interim results announced on 20 September 2023, the Company's management has reviewed the Chemistry, Manufacturing and Controls (CMC) programme for NTCD-M3, its product candidate for the prevention of Clostridioides difficile infection (CDI) recurrence. Following this review, the Company, along with its partner, Sebela Pharmaceuticals ("Sebela"), has now changed its contract development manufacturing organisation for NTCD-M3 in order to strengthen manufacturing for clinical trial material and improve future commercial supply. In doing so, this supports the transition of NTCD-M3 from a liquid to a solid dose formulation, which, based on market research is the preferred formulation, and therefore further strengthens the competitive profile of NTCD-M3. These improvements to CMC, which are under the remit of Destiny Pharma, mean that the company now expect drug product for the next stage of clinical development to be available in H2 2024. Sebela, who is responsible for the clinical development plan, is assessing the impact of these changes on the development plan. This may include a further Phase 2 study to de-risk Phase 3 study. As previously announced, Sebela has the right, at its own cost, to complete any further trials. Annuncio • Oct 17
Destiny Pharma plc Announces the Publication of New Microbiological Data on Xf-73 (Exeporfinium Chloride), Its Leading Antibacterial Drug,In Frontiers in Cellular and Infection Microbiology Destiny Pharma plc announced the publication of new microbiological data on XF-73 (exeporfinium chloride), its leading antibacterial drug,in Frontiers in Cellular and Infection Microbiology. The paper, 'Screening of the novel antimicrobial drug XF-73 against 2,527 Staphylococcus species clinical isolates',examined the efficacy of XF-73 against more than 2,500 Staphylococcus isolates with wide geographical and clinical diversity. These isolatesfrom 33 countries across Europe, North America, South America, Asia and Africa, encompass 16 different staphylococcal species, including resistant strains taken from patient infections such as skin and soft tissue infections, respiratory tract infections and hospital-acquired pneumonia. The screening of XF-73 against this wide range of isolatesyielded the following landmark findings: XF-73 effective against all 2,527 isolates tested; XF-73 effective against all tested antibiotic resistance mechanisms; XF-73effective against 840 MRSA1clinical isolates from around the world; XF-73 effective against S. epidermidis, S. saprophyticus, S. haemolyticus, S.capitis, S. hominis and S. lugdunensis - all of high clinical significance. These critical findings support the urgency of XF-73 nasal's late-stage development and need for its global regulatory approval. XF-73 demonstrates exceptionally broad potency across a huge range of Staphylococcus isolates, including antibiotic resistant strains, with no resistance observed. This study demonstrates XF-73's global effectiveness and reinforces the significant commercial opportunity. Importantly it also demonstrates the potential of XF-73 nasal to address the shortcomings of current standard of care nasal antibiotics, which contribute to the global rise in Staphylococcus aureus antibiotic resistance thereby limiting the effectiveness of current infection reduction approaches. Annuncio • Aug 24
Destiny Pharma plc to Report First Half, 2023 Results on Sep 20, 2023 Destiny Pharma plc announced that they will report first half, 2023 results on Sep 20, 2023 Annuncio • Jul 26
Destiny Pharma plc Appoints Sir Nigel Rudd as New Chairman Destiny Pharma plc announced that Sir Nigel Rudd will be returning as Company Chairman, effective immediately. Sir Nigel has an impressive track record in creating value for shareholders in a variety of business sectors. He has chaired the Business Growth Fund (supporting growth in many SMEs), Heathrow, Alliance Boots, Signature, Pilkington, Meggitt, and a number of other major companies. He was also Deputy Chairman of Barclays Bank for a number of years. Sir Nigel was previously Chairman of Destiny from 2010 to 2018 and led its flotation on the London AIM market. Annuncio • Jul 06
Destiny Pharma plc Confirms Proposed Phase 3 Development Pathway and Identifies New Life Cycle Management Targets for XF-73 Nasal Destiny Pharma recently held a meeting with its Scientific Advisory Board and a number of international experts from the UK and US focused on the XF-73 Nasal development programme. The panel of surgeons and infectious disease experts concluded that: The proposed XF-73 Nasal programme, consisting of two placebo-controlled surgical phase 3 studies with a clinical endpoint, designed around FDA input, reflects the utility of XF-73 Nasal in all surgeries. The rapid antimicrobial action of XF-73 Nasal gives greater flexibility in the scheduling of surgeries than existing offerings and provides direct value to patients and institutions. Antimicrobial resistance remains of global importance, with S. aureus and resistant strains such as MRSA and MupRSA of great concern clinically. XF-73 Nasal, through its unique and rapid mechanism of action, can play an important role in antibiotic stewardship by reducing the need for post-op systemic antibiotics. Additionally, XF-73 Nasal could prevent horizontal transmission of S. aureus, thus further contributing to good antibiotic stewardship. New potential life cycle management indications are available for Destiny to explore, particularly in children (and their families), where there are concerns over the use of mupirocin and antiseptic approaches and a high unmet medical need remains. Destiny Pharma has recentlycompleted detailed interactions with the regulatorsand identified options for the final Phase 3 clinical development stage to obtain approval for the XF-73 Nasal gel product in the US and Europe. The Company is actively seeking partners for the XF-73 Nasal programme. Board Change • Apr 20
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 11 experienced directors. No highly experienced directors. 2 independent directors (6 non-independent directors). Independent Non-Executive Director Debra Barker was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Annuncio • Dec 07
Destiny Pharma plc Announces Finalisation of its Phase 3 Development Plans for XF-73 Nasal Destiny Pharma plc announced that it has now finalised plans for its Phase 3 studies for its late-stage clinical asset, XF-73 Nasal. Highlights: Discussions held with US and EU Regulators and Clinical Key Opinion Leaders; Proposing two Phase 3 studies in two major surgery types to provide a broad surgery label for XF-73 Nasal; Phase 3 programme will deliver an approvable data package for both US and EU authorities; XF-73 Nasal targeting peak sales potential of $1 billion in its major target markets; Phase 3 patient recruitment could start in 2024 subject to completing a XF-73 Nasal partnering deal in 2023. XF-73 Nasal is the lead drug candidate developed from Destiny Pharma's XF platform and it is initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which can cause significant complications and increased healthcare costs in the hospital setting. The aim of the announced Phase 3 clinical programme is to deliver comprehensive clinical trial data demonstrating that nasal decolonisation using XF-73 Nasal, alongside "standard of care", reduces the incidence of post -surgical infections in patients. This meets the requirements of both the US and EU regulators - the FDA and EMA. After a detailed review, the Company has decided that the Phase 3 programme should consist of two Phase 3 studies including patients in two well-defined surgery models. One study will be in breast surgery as a model for general surgery and the other will be in expedited orthopedic surgery as a model of orthopedic surgery. This Phase 3 programme is expected to include up to 2,000 patients and deliver a comprehensive data set supporting a clinical endpoint in Surgical Site Infection ("SSI") reduction that is clinically and statistically significant. Successful clinical studies will therefore provide Destiny Pharma with a broad surgery label for its XF-73 Nasal gel thereby expanding product sales targets and maximizing the commercial opportunity. Post-surgical infections create a significant healthcare burden on hospitals and healthcare systems costing $10 billion per year in the US. A single MRSA post-surgical infection costs over $160,000 to treat and adds 15 days onto a hospital stay. In parallel, Destiny Pharma is considering two additional indications for XF-73 Nasal in oncology patients and in community acquired infections. These extra Phase studies would provide supportive data and life cycle management opportunities for XF-73. Having clarified the Phase 3 study designs, the Company is now expanding its partnering activities on XF-73 Nasal with the aim of securing a deal in 2023. Board Change • Nov 21
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 6 non-independent directors. Independent Non-Executive Director Debra Barker was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. 
