Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

Chair’s Investor Update

Brighton, United Kingdom – 28 July 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, today announces an Investor Update from its Chair, Nick Rodgers.

“I am delighted with the progress we are making despite a difficult stock market, particularly in the life sciences sector, and the challenging economic background. At the fundraising in March, we undertook to complete two key tasks in 2022 – clarification of the XF-73 Nasal Phase 3 trial plan to prevent post-surgical Staphylococcus aureus infections with the US FDA and a partnering deal for our NTCD-M3 Clostridioides difficile Infections (CDI) prevention therapy. We have progressed both tasks and look forward to further successes during the remainder of this year.

XF-73 Nasal and NTCD-M3

Clarification has been received from the FDA on our XF-73 Nasal Phase 3 clinical trial plans. The details of this encouraging feedback were recently announced on 19^th July. Additionally, we continue to progress partnering discussions on NTCD-M3 with the aim of announcing a deal before year end.

All the clinical data and competitor analyses we have reviewed and the market research we have undertaken gives us great confidence that both XF-73 and NTCD-M3, when approved by regulators, will deliver significant patient benefits and clear cost savings to hospitals and payers by reducing the incidence and expense of treating these life-threatening infections. Moreover, both have reported excellent Phase 2 clinical and safety data and show robust commercial models with the potential to generate over one US$ billion in peak sales.

I am particularly pleased that, within two years, we have been able to advance NTCD-M3 from its acquisition in November 2020 and develop the package through our expert regulatory, clinical and manufacturing efforts and are now close to delivering a partnering deal.  This is in line with the Company’s stated strategy of seeking partners to help co-fund the required Phase 3 development of our lead assets and lead the commercialization.

Other activity

While our focus remains on our two Phase 3 products we have sought to advance other aspects of our pipeline. Recently, we secured funding from the Cystic Fibrosis Foundation and also started a new research project targeted at Oral Mucositis. Our China partner, China Medical Systems, is carrying out pre-clinical work on their own XF-73 Dermal programme and SPOR-COV, our collaboration with SporeGen to develop a novel nasal spray to prevent viral respiratory infections, including COVID-19 and influenza, is in an exciting stage having almost completed the grant funded work.

I am extremely positive on the future of Destiny Pharma and I believe that our products can have a major impact in reducing infections worldwide and reduce healthcare costs. Our commitment to infection prevention is more relevant than ever and we have a very large opportunity to create significant value for our stakeholders including patients, healthcare systems and payers.”

Nick Rodgers

Chair

For further information please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com

Optimum Strategic Communications 
Mary Clark / Manel Mateus / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor and Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0) 207 220 0500

 MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV^TM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information on the company, please visit www.destinypharma.com

Forward looking statements

Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods. This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.

Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

Publication of new data on NTCD-M3 confirms potential as an effective treatment for prevention of C. difficile infections

Brighton, United Kingdom – 26 July 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, today announces 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 from Clostridioides difficile strain 630Δerm to nontoxigenic C. difficile strain 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.

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: “This is an important finding for NTCD-M3 as it demonstrates the inability for the transfer of the genes which encode for toxin production into our novel biotherapeutic product. This gives us additional confidence that such transfer will not occur clinically and supports our view that NTCD-M3 will deliver an effective and safe treatment to the many thousands of patients who experience a C. difficile infection”.

Professor Dale Gerding, Scientific Advisory Board Member of Destiny Pharma, added: “The transfer of the pathogenicity locus (PaLoc) which contains the toxin genes of toxigenic C. difficile, has been found to occur in laboratory experiments with certain strains of C. difficile. We were unable to demonstrate this transfer to NTCD-M3 in multiple laboratory attempts, suggesting that NTCD-M3 possesses mechanisms that resist such transfer. More importantly, such transfers have never been observed in animal models or humans treated with NTCD-M3, indicating that PaLoc transfer is highly unlikely to occur in clinical practice”.

Dale N. Gerding, MD MACP FIDSA FSHEA

Dr Dale Gerding is a Professor of Medicine in the Division of Infectious Diseases at Loyola University Chicago Stritch School of Medicine, Maywood, IL (retired) and Research Physician at the Edward Hines Jr. Veterans Affairs Hospital, Hines, IL where he maintains his active research laboratory. He is board certified in internal medicine and infectious diseases and a Master of the American College of Physicians and a member of the American Society for Microbiology. Dr Gerding discovered and developed the NTCD-M3 preventive treatment for C. difficile through its Phase 2 programme.

For further information please contact:

Destiny Pharma plc

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com

Optimum Strategic Communications 
Mary Clark / Manel Mateus / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor and Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0) 207 220 0500

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV^TM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information on the company, please visit www.destinypharma.com

Forward looking statements

Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.

Destiny Pharma plc
(“Destiny Pharma” or the “Company”)

Destiny Pharma announces positive update from US FDA on XF-73 Phase 3 development plans

• FDA clarifies Phase 3 and US registration pathway for XF-73 Nasal gel for the prevention of post-surgical staphylococcal infections
• Feedback enables the Phase 3 study design to be simplified and is expected to shorten the overall clinical development timelines

Brighton, United Kingdom – 19th July 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, is pleased to announce that it has received positive feedback from the US Food and Drug Administration (FDA) on the proposed XF-73 Nasal US 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 the development of a surrogate marker for clinical efficacy in other types of surgery.
• Based on the favourable 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 US.

Based on the FDA’s feedback, Destiny Pharma is now focused on finalising the US 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 US and across the world meaning that the XF-73 Nasal gel is targeting a multi-billion $ 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 US 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.

Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said: “Despite numerous initiatives in the past decades, S. aureus remains a major burden in the post-surgical setting. Nasal carriage of S. aureus is associated with a higher incidence of infections following surgery and significant morbidity and mortality for patients. This interaction with the FDA gives us clarity on the US registration pathway to filing a New Drug Application for XF-73 Nasal gel. Once approved, XF-73 Nasal gel will provide a new antimicrobial for rapidly and effectively decolonising nasal S. aureus and significantly reducing the patient risk and burden of the associated post-surgical infections.”

Alexander F. Mericli M.D., F.A.C.S. Associate Professor of Plastic Surgery at The University of Texas MD Anderson Cancer Center, noted: “If this compound is successful, it would be a game changer and revolutionise the safety of breast reconstruction (BR) surgery. The main complication that is most feared by breast surgeons is an infection. So, any effort or technology that decreases that fear, is incredibly valuable and a triumph for the field.”

The MD Anderson Cancer Center is a centre of excellence for cancer research and treatment, and it has been ranked the No. 1 hospital for cancer care in the US by different surveys.

Neil Clark, Chief Executive Officer of Destiny Pharma, added: “There is a significant, global commercial opportunity for XF-73 Nasal gel to help prevent hospital infections and to effectively decolonise patients undergoing a wide range of medical treatments. Its target product profile is to be a safe, fast and effective decolonising nasal gel that is cost effective for hospitals and easy to use in standard surgical protocols. The excellent progress our clinical team is achieving in the final design stages of the planned US Phase 3 clinical trial is fully in line with our stated strategy. This regulatory clarity will also assist us in our XF-73 Nasal gel partnering discussions.”

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com

Optimum Strategic Communications 
Mary Clark / Manel Mateus / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor and Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0) 207 220 0500

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV^TM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information on the company, please visit www.destinypharma.com

Forward looking statements

Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods. This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Destiny Pharma receives award from the Cystic Fibrosis Foundation

Study to investigate potential of XF-73 to treat MRSA infection in people with cystic fibrosis  

Brighton, United Kingdom – 12 July 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel, hospital infection prevention and treatment products that address the global challenge of antimicrobial resistance (AMR), today announces it has received an award from the Cystic Fibrosis Foundation. The research project will establish the potential of the Company’s proprietary XF-73 drug as a novel treatment for cystic fibrosis patients infected with methicillin-resistant Staphylococcus aureus (MRSA). The project will have access to clinical isolates collected from people with cystic fibrosis and the work will be carried out by experienced researchers associated with the Foundation. Financial terms of the collaboration have not been disclosed.

Neil Clark, Chief Executive Officer of Destiny Pharma, stated: “We are very excited to carry out this project with the Cystic Fibrosis Foundation. The tailored research will allow us to demonstrate the potential of XF-73 in alleviating the suffering of thousands of MRSA-infected cystic fibrosis patients and is another programme derived from our proprietary XF platform.”

Cystic fibrosis (CF) is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe. It is estimated that over 70,000 people worldwide are living with CF, with more than 30,000 in the US alone, and approximately 1,000 new cases diagnosed each year¹.

MRSA is becoming more common among the pathogenic bacteria that cause lung infections in CF patients, having a presence in about 25% of people with the disease².

MRSA is resistant to multiple antibiotics – biofilms are thought to be involved and lung infections caused by the bacteria often become long-term³. MRSA produces several virulence factors and its presence in the respiratory tract is associated with significant lung damage and is a major cause of mortality. The ability to treat such MRSA infections effectively would therefore significantly help CF patients.

Destiny Pharma’s lead compound, XF-73, is being prepared for Phase 3 clinical development to prevent post-surgical Staphylococcal infections. To date, XF-73 has demonstrated in vitro to be active against many of the world’s most pathogenic bacteria as outlined in the WHO priority list⁴. XF-73 acts via an ultra-rapid action, which kills bacteria (including antibiotic resistant strains), leaving them unable to mount a resistance response, according to Professor MacLean, Oxford University⁵. To date, no existing antibiotic resistance mechanism has been identified which confers resistance to XF-73. The spectrum of activity, the absence of an identified resistance mechanism and the ability to maintain its activity within biofilms puts XF-73 in a unique position to address important challenges posed by antimicrobial resistance (AMR).

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com

Optimum Strategic Communications 
Mary Clark / Manel Mateus / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor and Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0) 207 220 0500

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV^TM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information on the company, please visit www.destinypharma.com

¹ https://www.cff.org/intro-cf/about-cystic-fibrosis

² https://www.cff.org/managing-cf/methicillin-resistant-staphylococcus-aureus-mrsa

³ https://www.postersessiononline.eu/173580348_eu/congresos/ECFS2021/aula/-EPS3_9_ECFS2021.pdf

⁴ https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed

⁵ R. Craig MacLean, Assessing the Potential for Staphylococcus aureus to Evolve Resistance to XF-73. Trends in Microbiology, (2020), 1812.

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Destiny Pharma announces publication of XF-73 drug synergy data

XF-73 shown to enhance the activity of two antibacterial drugs

Findings may lead to improved treatments for lethal lung infections
and infected diabetic foot ulcers caused by antimicrobial resistant bacteria

Brighton, United Kingdom – 07 July 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, today announces the publication of new data on XF-73 with Cardiff University in Frontiers in Cellular and Infection Microbiology^[1] a peer-reviewed publication. This research project is partly funded through a £1.6m 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:

1. 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.
2. 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).

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, stated: “These latest data emerging from the highly successful InnovateUK, China AMR XF-based drug project have identified new opportunities to deliver better treatments for lung and DFU infections by using XF-73 alongside established antibacterial drugs. The addition of XF-73 significantly enhances the potency of these approved antibacterial drugs, which should improve their ability to treat such infections. We will be exploring the options for further research and development to progress XF-73 in such combinations to improve the treatment of these serious lung and DFU infections.”

Professor David Williams, Professor of Oral Microbiology, Cardiff University, added: “The control and management of infections involving antimicrobial resistant microorganisms is becoming increasingly problematic and as such there is urgent need for new and effective antimicrobials. An important strategy that can be exploited is combinational therapy involving multiple agents where synergistic effects are realised. This increases the efficacy of individual agents and reduces the risk of further development of resistance.”

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com

Optimum Strategic Communications 
Mary Clark / Manel Mateus / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor and Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0) 207 220 0500

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV^TM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF- drug research projects.

For further information on the company, please visit www.destinypharma.com

[1] https://doi.org/10.3389/fcimb.2022.904465

Destiny Pharma plc
(“Destiny Pharma” or the “Company”)

Destiny Pharma announces start of a new XF-73 research programme

Aim to test XF-73 as a potential preventive medicine for Oral Mucositis

Oral Mucositis is a common and devastating complication from chemotherapy and radiotherapy suffered by more than 2m cancer patients every year

Brighton, United Kingdom – 05 July 2022 – Destiny Pharma plc (AIM: DEST), a clinical-stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces 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 oral microbiome. 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.

Inflammation of the mucosa (mucositis) is considered one of the most serious non-hematological complications of cancer treatment and a common dose-limiting complication of high-dose radiotherapy and chemotherapy in cancer and bone marrow transplant patients of all ages. Globally, more than two million cancer patients suffer from this condition each year. The global OM market was estimated at $2.2b in 20181.

Despite its frequency and devastating impact, there are few approved preventive or treatment options available to help patients suffering from OM. Professor Stephen Sonis, DMD, DMSc, is a Professor of Oral Medicine at the Harvard School of Dental Medicine and also CSO at Biomodels, LLC. Prof. Sonis is a leading OM expert and his development of predictive research models has enabled investigation of the biological basis of cancer regimen-related epithelial injury in over 100 projects.

Neil Clark, Chief Executive Officer of Destiny Pharma, added: “Oral Mucositis is a very serious condition affecting millions of cancer patients across the world and is poorly treated by current products. A successful preventative product will save healthcare costs and improve patient care whilst supporting a stronger patient to complete their full course of treatment and thereby make a significant contribution to improved clinical outcomes. This new project utilises the unique profile of our XF platform in a new cancer related indication and we look forward to testing its potential in gold-standard OM models.”

ENDS

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com

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About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV^TM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information on the company, please visit www.destinypharma.com

Notes to Editors

About Oral Mucositis

Inflammation of the mucosa (mucositis) is a common dose limiting complication of high dose radiotherapy and chemotherapy in cancer patients of all ages. It can affect the mucosa of the entire gastrointestinal system from oral cavity to anus. Oral Mucositis (“OM”) is common and occurs in 40-70% of patients undergoing high dose radiotherapy and chemotherapy. OM is responsible for reduction or cessation of cancer treatment in 35% of patients, impacting the clinical outcome interventions (Sonis, 2014).

Despite its frequency and impact there are few approved preventive or treatment options. Existing treatments are unsatisfactory, consisting of mouthwashes and sprays containing anaesthetics, steroids, protective hydrogels and/or local pain management.

The target market for XF-73OM is estimated at over 2m OM patients/year. The global OM market was estimated at $2.2b in 2018 (OM Market Size, Growth and Trends by Cause – 2020) and is split across countries broadly in proportion to the incidence of cancer and chemotherapy treatments.

Smaller, targeted indications include BMT patients where severe OM is reported in >80% of patients. There are >2,000 BMTs every year in the UK and an estimated 50,000 BMTs are completed globally.

OM patients require specialised care such as parenteral nutrition, fluid replacement and anti-infective treatment. A single point increase in peak mucositis scores in hematopoietic stem cell transplant patients is associated with one additional day of fever, a 2‑fold increase in risk of significant infection, 2.7 additional days of total parenteral nutrition, 2.6 additional days of injectable narcotic therapy, 2.6 additional days in hospital and a 3.9 fold increase in 100-day mortality risk.

The healthcare cost of OM is substantial. In the US, the estimated cost of hospitalisation was $3,893/chemotherapy cycle without OM, $6,277/cycle with OM. In one study of patients receiving radiation therapy for head and neck cancer, OM was associated with an increase in costs ranging from $1,700 – $6,000/patient, depending on the grade of OM. Costs in UK and elsewhere are similar. OM is a global condition affecting all ages, races and genders.

1 OM Market Size, Growth and Trends by Cause – 2020