Duyuru • 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. Duyuru • 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. Price Target Changed • Jul 23
Price target increased by 29% to UK£2.60 Up from UK£2.01, the current price target is an average from 2 analysts. New target price is 7,314% above last closing price of UK£0.035. Stock is down 90% over the past year. The company is forecast to post a net loss per share of UK£0.061 next year compared to a net loss per share of UK£0.062 last year. Duyuru • 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 (15% 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 (UK£8.38m market cap, or US$10.6m). Duyuru • 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. Price Target Changed • May 25
Price target increased by 29% to UK£2.60 Up from UK£2.01, the current price target is an average from 2 analysts. New target price is 1,548% above last closing price of UK£0.16. Stock is down 48% over the past year. The company is forecast to post a net loss per share of UK£0.061 next year compared to a net loss per share of UK£0.062 last year. Duyuru • 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 Duyuru • 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 Price Target Changed • Feb 27
Price target increased by 41% to UK£2.82 Up from UK£2.01, the current price target is an average from 2 analysts. New target price is 662% above last closing price of UK£0.37. Stock is up 8.8% over the past year. The company is forecast to post a net loss per share of UK£0.067 next year compared to a net loss per share of UK£0.093 last year. Duyuru • 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. Price Target Changed • Oct 22
Price target increased by 41% to UK£2.82 Up from UK£2.01, the current price target is an average from 2 analysts. New target price is 395% above last closing price of UK£0.57. Stock is up 63% over the past year. The company is forecast to post a net loss per share of UK£0.071 next year compared to a net loss per share of UK£0.093 last year. New Risk • Oct 18
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of British stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 20% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (UK£13m net loss in 3 years). Shareholders have been diluted in the past year (30% increase in shares outstanding). Revenue is less than US$5m (UK£986k revenue, or US$1.2m). Market cap is less than US$100m (UK£57.6m market cap, or US$70.0m). Duyuru • 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. Duyuru • 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 Duyuru • 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. Duyuru • 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. Price Target Changed • May 09
Price target increased by 34% to UK£2.70 Up from UK£2.01, the current price target is an average from 2 analysts. New target price is 680% above last closing price of UK£0.35. Stock is down 21% over the past year. The company is forecast to post a net loss per share of UK£0.077 next year compared to a net loss per share of UK£0.093 last year. Board Change • Nov 16
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. Price Target Changed • Sep 08
Price target increased to UK£2.50 Up from UK£1.99, the current price target is an average from 3 analysts. New target price is 586% above last closing price of UK£0.36. Stock is down 70% over the past year. The company is forecast to post a net loss per share of UK£0.13 next year compared to a net loss per share of UK£0.089 last year. Duyuru • Sep 07
Destiny Pharma plc Positive update from EMA on NTCD-M3 Phase 3 plans Destiny Pharma plc announced that it has received positive feedback from the European Medicine Agency on the proposed NTCD-M3 Phase 3 development programme. NTCD-M3 is the lead clinical candidate being developed by Destiny Pharma for the prevention of the recurrence of infections caused by toxic strains of the gut bacteria Clostridioides difficile, which can cause significant inflammation and damage to the gut leading to an estimated 29,000 deaths annually in the US alone, a number comparable to the yearly deaths from prostate cancer. It is estimated CDI adds an extra $6 billion to US healthcare costs per annum while in Europe, the economic burden caused by CDI is estimated at $3 billion and increasing. The key points from the EMA's feedback are that they have agreed: With the overall comparability plans relating to the development of the new easy-to-use capsule formulation of NTCD-M3, thus lifting any requirements for human trials to demonstrate such comparability: That the proposed single trial Phase 3 design to be sufficient for a MAA also endorsing the primary and secondary endpoints of the proposed Phase 3 study: That the overall proposed safety database will be collected through the conduct of the proposed Phase 3 trial and that this would be sufficient for a MAA To remove the requirement of a thorough QT study for NTCD-M3 development programme: NTCD-M3 is a novel biotherapeutic for prevention of recurrence of CDI and it is composed of a single bacterial strain, a naturally occurring non-toxigenic C. difficile strain -M3. Rather than acting by restoring the microbiota after the antibiotics used to treat the infection have disrupted the gut microbiota it acts by colonising the gut with a harmless non-toxigenic strain of C. difficile, which prevents subsequent colonisation by toxigenic strains and allows the normal microbiota to recover on its own. NTCD-M3 colonisation is both safe and effective and does not permanently alter the microbiota. If NTCD-M3 is successful in its planned Phase 3 trials in around 800 patients, it will be approved under a BLA by the FDAin the USfor the prevention of recurrence in CDI and under a MAA in Europe. The NTCD-M3 development focuses on patients with a primary episode of CDI and first recurrence. Thus, it is clearly differentiated from other products in development as NTCD-M3 is positioned as an early intervention to reduce the risk of recurrences. According to the US Center for Disease Control and Prevention, C. difficile causes almost half a million infections in the USA each year. This number clearly indicates how significant the impact of C. difficile infections is on healthcare costs and the potential for NTCD-M3 to prevent these costs and to bring substantial value to healthcare systems and the patients in need. It represents a significant commercial opportunity for Destiny Pharma. Duyuru • Aug 22
Destiny Pharma plc to Report First Half, 2022 Results on Sep 08, 2022 Destiny Pharma plc announced that they will report first half, 2022 results on Sep 08, 2022 Duyuru • Jul 26
Destiny Pharma plc Announces Publication of New Data on NTCD-M3 Destiny Pharma plc announced publication of new data on NTCD-M3, its novel treatment for the prevention of C. difficile infection (CDI) recurrence, in the peer reviewed journal Public Library of Science One (PLOS ONE): Absence of toxin gene transfer fromClostridioides difficilestrain 630?erm to nontoxigenicC. difficilestrain NTCD-M3r in filter mating experiments | PLOS ONE). CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year, many of these initial cases then recur leading to 29,000 deaths per year. The study, carried out by Professor Dale Gerding and his team at the VA Hines laboratories (US), examined in vitro the potential for the transfer of the gene responsible for toxin production from a toxigenic strain of C. difficile to NTCD-M3. Such a transfer would be undesirable as it is the toxins produced that are responsible for causing serious gut irritation and major life-threatening symptoms of this common hospital gut infection. The study demonstrated that attempted conjugations using a toxigenic C. difficile strain (630?erm) as a gene donor, failed to show toxin gene transfer to NTCD-M3 but confirmed transfer to a different NTCD strain, namely CD37, which had previously been reported (Brouwer MSM, Roberts AP, Hussain H, Williams RJ, Allan E, Mullany P. Horizontal gene transfer converts non-toxigenic Clostridium difficile strains into toxin producers. Nat Commun. 2013;4: 2601 doi: 10.1038/ncomms3601. pmid:24131955). Destiny Pharma is currently finalising preparations for the pivotal Phase 3 clinical trial of NTCD-M3 and seeking partners to help co-fund studies and lead commercialisation of this exciting biotherapeutic product. NTCD-M3 has previously reported very good Phase 2 clinical trial results. Duyuru • Jul 19
Destiny Pharma plc Receives Positive Feedback from the U.S. Food and Drug Administration Destiny Pharma plc announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed XF-73 Nasal U.S. Phase 3 study design and development programme. XF-73 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 key points from the FDA's feedback are: The FDA agreed to the proposed Phase 3 design comparing XF-73 Nasal gel to placebo on top of standard of care for the prevention of post-surgical staphylococcal infections following certain breast surgery operations. This type of surgery is being proposed as patients can experience a relatively high infection rate following the current standard of care and there is a clear unmet medical need. The FDA is open to the collection of microbiological data during the proposed Phase 3 study that could lead to thedevelopment of a surrogate marker for clinical efficacy in other types of surgery. Based on the favorable safety profile from the clinical development programme so far, the FDA has confirmed that no specialised nasal examinations are needed in the Phase 3 study. In line with the above, the FDA has also removed the previous requirement to clinically evaluate skin sensitisation. The regulatory feedback will enable Destiny Pharma to simplify the Phase 3 study design and is expected to shorten the overall clinical development programme in the U.S. Based on the FDA's feedback, Destiny Pharma is now focused on finalising the U.S. study design and biostatistical analysis to clarify the final patient numbers required and the related costings and timeline. The Company is also exploring the possibility of designing a global Phase 3 clinical programme, likely to consist of two studies, that meets the requirements of both the FDA and European Medicines Agency (EMA) and a further update on this will be made in due course. The breast surgery patient population for the Phase 3 clinical trial has been chosen to meet FDA requirements for a "placebo plus standard of care" comparator with the primary endpoint being statistically significant evidence that the use of XF-73 Nasal gel results in fewer post-surgical site infections. The Company is confident that positive Phase 3 results will mean that XF-73 Nasal gel will be used in breast surgery and more widely in the many other surgical procedures where decolonisation is recommended. It is estimated that approximately one third of the global population are carriers of S.aureus, typically in the nose, putting them at a significantly higher risk of acquiring a post-surgical infection. Consequently, nasal decolonisation is recommended across many high-risk surgeries which is a very large patient population in the U.S. and across the world meaning that the XF-73 Nasal gel is targeting a multi-billion dollar market opportunity in the hospital setting. The need for better anti-microbial treatments such as XF-73 Nasal gel, is underlined by XF-73 having previously been awarded FDA Qualifying Infectious Disease Product (QIDP) and Fast Track status. In the U.S. and worldwide, there are no approved nasal drugs for the prevention of post-surgical staphylococcal infections. The generic antibiotic mupirocin has been used to treat patients who carry the bacteria prior to surgery to reduce the risk of infection. However, the use of existing preventative treatments is severely limited by the existence, and fear of generating drug resistant bacteria. In contrast, XF-73 Nasal gel has been shown not to generate drug-resistant bacteria and thereby reduces the threat posed by Anti-Microbial Resistance (AMR). Furthermore, this superior bacterial resistance profile makes it ideally suited for widespread use in the prevention of post-surgical infections. Duyuru • Jul 07
Destiny Pharma plc Announces Publication of XF-73 Drug Synergy Data Destiny Pharma plc announced the publication of new data on XF-73 with Cardiff University in Frontiers in Cellular and Infection Microbiology a peer-reviewed publication. This research project is partly funded through a £1.6 million collaboration between Destiny Pharma, Cardiff University, China Medical Systems and University of Tianjin. The collaboration was established under the UK-China AMR grant fund set up by Innovate UK and the Department of Health and Social Care with the Chinese Ministry of Science and Technology. These new in vitro data were generated by Dr. Emma Board-Davies and Professor David Williams at the School of Dentistry, Cardiff University, in experiments studying the potential for XF-based drugs to enhance the effectiveness of key antibacterial treatments - many of which are now suffering from the emergence of bacterial resistance mechanisms. Multiple combinations of XF-based drugs and selected antibacterials were assessed and enhanced effectiveness beyond the action of the antibacterial drug alone was identified. The new findings were: Synergistic effect when XF-73 was combined with polymyxin B, a last resort antibacterial drug used to treat life-threatening lung bacterial infections. The addition of XF-73 was found to enhance polymyxin B potency against Pseudomonas aeruginosa, a top priority WHO bacterial pathogen, by 4-fold. Synergistic effect when XF-73 was combined with ertapenem, used to treat infected diabetic foot ulcers (DFUs). The addition of XF-73 was found to enhance ertapenem potency against methicillin-resistant Staphylococcus aureus (MRSA), another top priority WHO bacterial pathogen, by 8-fold. These positive results open the way for further studies with multidrug resistant strains of Pseudomonas aeruginosa and MRSA to progress the combination of XF-73 with these antibacterials as potential new treatments for serious lung and DFU infections. The new data further add to the existing published research and clinical data relating to the XF platform and XF-73. These data clearly demonstrate the attributes of XF-based drugs and their significant potential to provide much needed new treatments that will prevent and/or treat serious infections and address the global threat of antimicrobial resistance (AMR). Duyuru • Jul 05
Destiny Pharma plc Starts New Research Programme Destiny Pharma plc announced that it has started a new research programme. The research study will be conducted in the US by Oral Mucositis ("OM") expert Professor Stephen Sonis and will investigate the potential of XF-73 as a preventive medicine to alleviate suffering from OM in patients receiving cancer treatment by testing its efficacy in the gold-standard model of OM. The potential utility of XF-73 in this indication is due to the long-recognised association between the development of OM and changes in the oralmicrobiome. The unique antimicrobial properties of XF-73 have already been demonstrated in Phase 2 clinical trials. As well as having fast-acting antimicrobial activity and a novel mechanism of action, XF-73 has an excellent safety profile and a lack of systemic exposure which means that it is ideally suited for development as an innovative oral formulation to reduce the severity of OM. Duyuru • May 27
Destiny Pharma plc Announces Board Changes Destiny Pharma plc announced the appointments of James Stearns, Aled Williams and Nigel Brooksby as Non-Executive Directors with effect from 1 June 2022. James Stearns is replacing Dr Huaizheng Peng. The Company has been looking to add Non-Executive Directors following the retirement of Peter Morgan in March this year and has decided to add Aled and Nigel as two new appointments. The Board has expanded its skills and experience base through these additions and is well positioned to continue to deliver its strategy. James Stearnsis the Chief Investment Officer (Europe and America) of China Medical System Holdings Limited (CMS), focusing on its M&A driven growth strategy and overseeing the Venture Programme. James brings considerable experience in the financial markets having previously worked for both the sellside (Director, Corporate Broking and Advisory at Panmure Gordon) and buyside (Investment Director at LivingBridge). James holds a Joint Honours degree from the University of Bristol in Economics and Accounting. Aled Williams is Chief Executive Officer ofEnthera Pharmaceuticals Srl andwas recently Chief Business Officer of Polyneuron Pharmaceuticals Ag.Aled has over 25 years of leadership experience in the pharmaceutical industry, holding senior positions in large pharmaceutical companies (AstraZeneca, Pfizer, Novartis and Bristol-Myers Squibb) and multiple executive management roles in smaller biotech companies. Aled has spent much of his career with responsibility for the external interface from a company, portfolio and asset perspective across a range of different disease areas, including anti-infectives. A microbiologist by training, prior to joining the pharma & biotech industry Aled spent a number of years working in public health. Nigel Brooksby has extensive experience in the life science sector and has been involved as Chair/Director/Strategic Adviser in several fund raisings, including advising Akari Therapeutics on its 2015 NASDAQ listing. Nigel has also undertaken many projects assisting biotech companies in their partnering arrangements with major pharmaceutical companies and has previously held senior global roles at Sanofi, Wellcome (now GSK) and Pfizer. Until his retirement in 2010, Nigel was a Member of theSanofi Executive Committee in Europe and North America, and Chair and Managing Director of the Sanofi Group in the UK and Ireland. He has worked internationally based in Europe, the USA, Latin America, the Middle East and Africa. Duyuru • May 13
Destiny Pharma plc Announces Landmark NTCD-M3 Data to Be Presented At Anaerobe Destiny Pharma announced that data generated from a recent C. difficile infection (CDI) model study, on the ability of non-toxigenic C. difficile strain M3 (NTCD-M3) to successfully colonise the gut following administration of antibiotics, has been accepted for presentation at the prestigious Anaerobe 2022 Conference in Seattle, WA, US on 30th July 2022. As previously reported, a Phase 2 clinical trial in patients suffering CDI demonstrated that administration of NTCD-M3 shortly after the use of antibiotics to treat the initial infection successfully reduced recurrence from 30% in placebo to 5% in treated patients. Patients received either vancomycin or metronidazole to treat the initial toxic C. difficile infection before receiving NTCD-M3 treatment.[1] Since the end of this trial, a new antibiotic, fidaxomicin, has been added to US clinical guidelines for treating CDI[2]. It is known that fidaxomicin3 resides for a longer period within the gut potentially inhibiting the colonisation by bacteria such as NTCD-M3. This latest study by the Microbiology Research Laboratory at the Edward Hines, Jr. VA Hospital in the US sought to address this question by monitoring the colonisation of NTCD-M3 in an established CDI model following administration of fidaxomicin. Duyuru • May 05
Destiny Pharma plc Appoints Yuri Martina as Chief Medical Officer Destiny Pharma plc announced the appointment of Dr. Yuri Martina as Chief Medical Officer (CMO). Yuri brings to the company more than 20 years' experience and an extensive record of excellence in clinical development and successful interactions at the highest levels with key regulatory, industry and government stakeholders including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceutical and Medical Device Agency (PMDA). Most recently, Yuri was Senior Vice President Development and deputy CMO at Grünenthal Group where he was a key member of the Global R&D Leadership and the Global Commercial Leadership Teams. Price Target Changed • Apr 27
Price target decreased to UK£3.06 Down from UK£3.70, the current price target is an average from 2 analysts. New target price is 531% above last closing price of UK£0.48. Stock is down 67% over the past year. The company is forecast to post a net loss per share of UK£0.14 next year compared to a net loss per share of UK£0.089 last year. Board Change • Apr 27
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. 4 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. Duyuru • Apr 05
Destiny Pharma plc to Report Fiscal Year 2021 Results on Apr 12, 2022 Destiny Pharma plc announced that they will report fiscal year 2021 results on Apr 12, 2022 Price Target Changed • Mar 10
Price target decreased to UK£3.06 Down from UK£3.70, the current price target is provided by 1 analyst. New target price is 488% above last closing price of UK£0.52. Stock is down 52% over the past year. The company is forecast to post a net loss per share of UK£0.088 next year compared to a net loss per share of UK£0.12 last year. Duyuru • Feb 09
Destiny Pharma plc Receives Positive Scientific Advice from the European Medicines Agency Destiny Pharma plc has received positive Scientific Advice from the European Medicines Agency (EMA) following its review of Destiny Pharma's proposed Phase 3 clinical programme design. This pivotal Phase 3 programme is expected to lead to the registration of the XF-73 nasal gel as a new drug in Europe. The company also announced findings from a recently commissioned, independent market research study which reinforces the clinical support and market potential of XF-73 Nasal gel in Europe. XF-73 is the lead drug candidate from Destiny Pharma's XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. The key highlights of the EMA advice are as follow: A simple, microbiological primary endpoint is acceptable for European approval of the XF-73 nasal gel. It will measure the percentage of patients demonstrating decolonisation to a level of eradication. This is consistent with the primary endpoint used in the very successful Phase 2b clinical study that reported outstanding results in 2021; Agreement that the patient population to enroll in the Phase 3 trials will be those who are nasal carriers of S. aureus (approximately a third of all patients) undergoing surgeries that put them at risk of a post-surgical S. aureus or MRSA infection. This is consistent with the patient population enrolled in the successful Phase 2b; It has been agreed that in Europe XF-73 Nasal gel would be compared to a "standard of care" mupirocin treatment in the Phase 3 programme; mupirocin is the old dermal antibiotic widely used across the world for nasal decolonization; Agreement with the proposed XF-73 Nasal gel product pack approach for Phase 3 and its commercial suitability for the European market. This positive advice is welcomed by the Company as it identifies a clear route through European approval of XF-73 Nasal gel as a ground-breaking hospital infection prevention product. The company also in discussions with the FDA on a study design suitable to gain US approval which, combined with the EMA feedback, will finalise the global Phase 3 clinical strategy for the XF-73 Nasal gel product. XF-73 has been awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the US Food & Drug Administration (FDA). Duyuru • Feb 02
Destiny Pharma plc Announces Positive Results in XF-73 Dermal Safety Study from Ongoing Agreement with US Government's NIAID Destiny Pharma plc announced the successful completion of a preclinical safety study with a novel XF-73 dermal formulation. The study was the first of two preclinical safety studies of its lead XF-73 Dermal formulation carried out as part of a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health. The study met its objectives and generated positive data, which clears the path for its progression into the second and final clinically-enabling regulatory safety study. Both studies are being conducted through NIAID's suite of preclinical services. Destiny Pharma is developing a novel formulation of XF-73 (XF-73 Dermal) for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers. Destiny Pharma will continue to work with NIAID to complete this preclinical safety package that will support future clinical development of XF-73 Dermal in serious wound infections. The study is planned to complete in 2022. Duyuru • Jan 24
Destiny Pharma plc Announces Successful Outcome of Cooperative R&D Agreement with US Department of Veterans Affairs with NTCD-M3 Destiny Pharma plc announced the successful outcome of the Cooperative R&D agreement with the US Department of Veterans Affairs with NTCD-M3, a novel microbiome therapeutic being developed to reduce the recurrence of Clostridioides difficile infections (CDI) in the gut. The research results confirmed NTCD-M3's ability to colonise the gut after antibiotic administration, which strengthens the market opportunity as it supports its use following commonly used antibiotic treatments. The Company also announces findings from North American and European market research which reinforce the clinical support and market potential of NTCD-M3. Oral antibiotics kill beneficial bacteria in the gut, causing unintentional and harmful collateral damage. This allows Clostridioides difficile to grow in the gut and release toxins which cause disease. CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year. It is estimated that CDIs result in an additional US$6 billion in healthcare costs per year in the US alone. Destiny Pharma's late-stage asset NTCD-M3, which has already completed successful Phase 2 clinical trials, has been shown to prevent recurrence following the normal standard-of-care antibiotic treatment with only a 5% recurrence rate - the Company believes this is the biggest reported reduction in CDI recurrence from clinical studies. Some antibiotics used for the treatment of CDI, including fidaxomicin (Dificid®), can remain in the gut for a prolonged period after treatment, potentially impacting the ability of NTCD-M3 to colonise and prevent infection recurrence. The US Department of Veterans Affairs conducted a preclinical study using the best accepted CDI research model. The study demonstrated successful (100%) gut colonisation of NTCD-M3 following treatment with fidaxomicin (Dificid®). In addition, successful (100%) NTCD-M3 gut colonisation was also demonstrated following pre-treatment with vancomycin, the most commonly used first-line antibiotic treatment for CDI. These results provide further support and rationale for the use of NTCD-M3 as an adjunct to both current standard-of-care treatments, vancomycin and fidaxomicin, for the prevention of CDI recurrence. Recent Insider Transactions • Jun 12
Founder recently sold UK£420k worth of stock On the 10th of June, William Love sold around 350k shares on-market at roughly UK£1.20 per share. This was the largest sale by an insider in the last 3 months. This was William's only on-market trade for the last 12 months. Duyuru • Jun 10
Destiny Pharma plc Announces XF-73 Data Abstract to Be Presented At 2021 ECCMID Destiny Pharma plc announced that an abstract providing analysis and discussion of the late-breaking data arising from the recently completed Phase 2b clinical study of XF-73 nasal gel has been accepted for presentation at Europe's premier antimicrobials congress, the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), to be held 9 - 12 July, 2021. Presentation Title: Repeated doses of exeporfinium chloride (XF-73) nasal gel over 24 hours significantly reduced the burden of Staphylococcus aureus nasal carriage in at-risk surgical patients: preliminary results from a Phase 2 study. The presentation will update the audience on the following highlights: Met primary endpoint: XF-73 reduced the mean nasal burden of S. aureus in patients undergoing open heart surgery by 2.5 log (CFU/ml) in the 24 hours immediately before surgery a highly statistically significant result, (p<0.0001). This equates to a 99.5% reduction in S. aureus bacterial nasal carriage, which is a very effective reduction by accepted clinical measures. XF-73 showed 2.1 log, (>99%), greater reduction than placebo in the same patient population and this difference in reduction of nasal burden of S. aureus was highly statistically significant (p<0.0001). The effect was maintained during surgery, considered the period when the risk for infections is the highest. These positive results were achieved with just three doses of 0.2% (w/w) XF-73 nasal gel in the 24 hours before incision and the start of surgery. There were no XF-73 nasal gel treatment related adverse events. Duyuru • Mar 17
Destiny Pharma plc to Report Fiscal Year 2020 Results on Apr 14, 2021 Destiny Pharma plc announced that they will report fiscal year 2020 results on Apr 14, 2021 Duyuru • Mar 16
Destiny Pharma Announces Agreement with NIAID to Evaluate A Novel XF-73 Formulation in Skin Wound Infection Destiny Pharma plc announced it has entered into a Non-Clinical Evaluation Agreement with the US government's National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health, to evaluate the preclinical safety of a dermal formulation of XF-73. Under NIAID's suite of preclinical services, NIAID-funded contractors will conduct these clinically enabling safety studies. Destiny Pharma is developing a novel formulation of XF-73 for the prevention of infection associated with open wounds and broken skin. This programme has previously demonstrated positive results across a range of preclinical efficacy studies and two Phase 1 dermal irritancy trials. Destiny Pharma will utilize NIAID's preclinical services programme to complete the preclinical safety studies that will support the planned clinical development in serious wound infections. Destiny Pharma will provide the XF-73 formulation to be tested in these preclinical studies and the project is planned to complete in 2022. Is New 90 Day High Low • Mar 15
New 90-day high: UK£1.33 The company is up 111% from a price of UK£0.63 on 15 December 2020. Outperformed the British market which is up 5.0% over the last 90 days. Exceeded the Biotechs industry, which is up 24% over the same period. Is New 90 Day High Low • Feb 11
New 90-day high: UK£1.27 The company is up 91% from its price of UK£0.67 on 12 November 2020. The British market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 26% over the same period. Duyuru • Feb 02
Destiny Pharma plc Announces the Appointment of Mark Wilcox to its Scientific Advisory Board Destiny Pharma Plc announced the appointment of Professor Mark Wilcox to its Scientific Advisory Board (SAB). Professor Wilcox is a consultant microbiologist and Head of R&D in Microbiology at the Leeds Teaching Hospitals and is Lead on Clostridium difficile infection for Public Health England (PHE). He also has advisory roles to UK SAGE (COVID-19), NHS England's Infection Prevention & Control national team and PHE's Rapid Review Panel (reviewing the utility of infection prevention and control products for the NHS), and is a member of the UK NHS Antimicrobial Resistance Programme Board. Is New 90 Day High Low • Jan 14
New 90-day high: UK£1.13 The company is up 54% from its price of UK£0.73 on 16 October 2020. The British market is up 14% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 12% over the same period. Duyuru • Jan 08
Destiny Pharma Appoints Stephanie Bewick as CBO Destiny Pharma plc announces the appointment of Dr Stephanie Bewick as Chief Business Officer. Dr Bewick brings 20 years' experience in business development at public and private biotech companies as well as mid-sized pharma, both in-house and as a consultant. Most recently, she was Vice President, Business Development at Summit Therapeutics, a NASDAQ-listed infectious disease company, leading the out-licensing and in-licensing activities, pipeline positioning and technology valuation. Duyuru • Jan 05
Destiny Pharma plc Completes Phase 2b Trial of XF-73 Recruitment Destiny Pharma plc announces that its XF-73 Phase 2b clinical trial was fully recruited by 31 December 2020, meeting the target timeline set for the programme. XF-73 is a first-in-class drug candidate from Destiny Pharma's XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. It has been awarded both qualifying infectious disease product (QIDP) and Fast Track status by the US FDA. The Phase 2b trial is a multi-centre, randomised, blinded, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal Staphylococcus aureus nasal carriage in up to 125 patients scheduled for open heart surgery. The Phase 2b trial design is closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the efficacy of XF-73 versus placebo in reducing Staphylococcus aureus nasal carriage in healthy volunteers. Previous clinical and scientific data supports XF-73 as having a novel mechanism of action and being a safe, fast and targeted anti-infective agent. In microbiological studies it has also shown to not generate anti-microbial resistance (AMR) and therefore has the potential to have a clear advantage over older antibiotic treatments that can lead to the generation of drug resistant "superbugs". Is New 90 Day High Low • Oct 24
New 90-day high: UK£0.88 The company is up 184% from its price of UK£0.31 on 24 July 2020. The British market is down 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Duyuru • Oct 14
Destiny Pharma plc Announces Clinical Study Patient Recruitment Update Destiny Pharma plc announced an update on its XF-73 Phase 2b clinical study with 101 patients out of the target of 125 now recruited. The Phase 2b clinical study is recruiting patients undergoing open heart surgery in United States and Europe. Subject to recruitment being slowed again by the impact of COVID-19, the study is expected to complete recruitment before the end of the year and report results in First Quarter 2021. The ongoing Phase 2b trial is a multi-centre, randomised, blinded, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal Staphylococcus aureus nasal carriage in 125 patients scheduled for open heart surgery. The Phase 2b study design is closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the clinical efficacy of XF-73 versus placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers. Is New 90 Day High Low • Oct 07
New 90-day high: UK£0.65 The company is up 78% from its price of UK£0.36 on 08 July 2020. The British market is down 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Duyuru • Sep 10
Destiny Pharma plc to Report First Half, 2020 Results on Sep 17, 2020 Destiny Pharma plc announced that they will report first half, 2020 results on Sep 17, 2020