22 September 2022 – Notice of R&D Update Meeting

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

Notice of R&D Update Meeting

Brighton, United Kingdom – 22 September 2022 – Destiny Pharma plc (AIM:DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, today announces that it will host an R&D Update meeting for analysts and investors on Tuesday, 18 October 2022 at 1.00 pm BST / 8.00 am EST.

The R&D Update meeting will be held in person at finnCap Ltd, 1 Bartholomew Close, London, EC1A 7BL, with the option of virtual attendance via the Investor Meet platform.

The meeting, which is scheduled to last around two hours, will include an update on the status of NTCD-M3 and XF-73, the Company’s two lead clinical programmes, by Dr Yuri Martina, Chief Medical Officer, and Dr Stephanie Bewick, Chief Business Officer, as well as a short update on its earlier pipeline assets.

In addition, there will be presentations by senior Key Opinion Leaders on:

  • Recurrence in C. difficile infection (CDI) – the unmet medical need by Professor Mark Wilcox, Consultant Microbiologist and Head of R&D in Microbiology at the Leeds Teaching Hospital and member of Destiny Pharma’s Scientific Advisory Board.
  • Surgical site infection in breast reconstruction surgery – a Plastic Surgeon’s view by Dr Alex Mericli, Associate Professor and Plastic Surgeon at MD Anderson Cancer Center.

There will be an opportunity for Q&A with the speakers and Destiny Pharma’s management team.

Prior registration for the event is required. To attend in person please contact RD@destinypharma.com. To attend virtually, investors can sign up to Investor Meet Company for free, and add to meet Destiny Pharma plc via:

https://www.investormeetcompany.com/destiny-pharma-plc/register-investor

Investors who already follow Destiny Pharma plc on the Investor Meet Company platform will automatically be invited to the event. Questions can be submitted pre-event via the Investor Meet Company Dashboard up until 1.00 pm BST / 8.00 am EST the day before the meeting, or at any time during the live presentation.

For further information, please contact:

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

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

Optimum Strategic Communications
Mary Clark / Nick Bastin / Manel Mateus
+44 (0) 208 078 4357
DestinyPharma@optimumcomms.com

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

Stern IR – US
Janhavi Mohite
+1-212-362-1200
Janhavi.Mohite@sternir.com

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 SporCov, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF research projects.

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

 

Notes to Editors

Mark H Wilcox, MD, FRCPath
Professor Mark Wilcox is an expert in infectious disease and currently serves in several substantive roles including: a Consultant Microbiologist and Head of Research and Development in Microbiology at the Leeds Teaching Hospitals (LTHT).  Professor Wilcox is also the Infection Lead of Leeds NIHR Diagnostic Technologies Medical Technology and In Vitro Diagnostic Co-operative; Professor of Medical Microbiology at the University of Leeds; National Clinical Director of AMR for NHS Improvement/England (NHSE/I); and Lead on Clostridium difficile for Public Health England .

He serves in multiple advisory roles, including to UK SAGE (COVID-19), as co-chair of the UK Technical Validation Group for COVID-19 tests, as a medical advisor to the National Infection Prevention & Control Lead (NHSE/I), the Medical Research Council’s Infection and Immunity Panel, as Chair of PHE’s Rapid Review Panel  and member of the UK NHS Antimicrobial Resistance Programme Board. Professor Wilcox was formerly the Director of Infection Prevention (4 years), Infection Control Doctor (8 years), and Clinical Director of Pathology (6 years) at LTHT and Head of Microbiology (15 years).

Dr Alex Mericli
Dr Mericli is an Associate Professor of Plastic Surgery at The University of Texas MD Anderson Cancer Center. He completed his plastic surgery residency at the University of Virginia, followed by a fellowship in microvascular and reconstructive surgery at MD Anderson. Dr Mericli is interested in all aspects of reconstructive surgery with particular attention to breast, head and neck, and trunk reconstruction. He is dedicated to surgical research and education, having received numerous awards and has authored or co-authored over 70 peer-reviewed articles and book chapters on various plastic surgery topics and lectured nationally and internationally on his research.

Dr Mericli also serves as the Medical Director for Perioperative Surgical Services at MD Anderson. In this role he leads a number of efforts and strategies aimed at optimizing the efficiency of the main and Mays operating rooms. Dr Mericli is a champion of value-based care – both in theory and in practice – and has published a number of articles detailing the cost-effectiveness of several different plastic surgery procedures and technology.

07 September 2022 – Destiny Pharma CEO, Neil Clark, to present at the HC Wainwright 24th Annual Global Investment Conference

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

Destiny Pharma CEO, Neil Clark, to present at the HC Wainwright 24th Annual Global Investment Conference

Brighton, United Kingdom – 7 September 2022 – Destiny Pharma plc (AIM:DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, today announces that Destiny Pharma’s CEO, Neil Clark, will present virtually at the upcoming HC Wainwright 24th Annual Global Investment Conference, being held on 12-14 September 2022 in New York and virtually.

The presentation will be available to view on demand from 1200 BST / 0700 ET on Monday 12 September 2022.  To join the conference virtually, view the presentation and ask any questions, please click on the link above to register.

Presentation Title:      Destiny Pharma Company Presentation

Presenter:                     Neil Clark

If you would like to meet with Destiny Pharma, please email us at conferences@destinypharma.com or contact us through the HC Wainwright conference meeting system if you are registered.

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 /Vici Rabbetts
+44 (0) 208 078 4357
DestinyPharma@optimumcomms.com

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

Stern IR – US
Lilian Stern / Janhavi Mohite
+1-212-362-1200

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 SporCov, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF research projects.

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

07 September 2022 – Positive update from European Medicine Agency (EMA) on NTCD-M3 Phase 3 development plans

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

Destiny Pharma announces positive update from European Medicine Agency (EMA) on NTCD-M3 Phase 3 development plans

  •  EMA endorses Destiny Pharma’s proposed single pivotal Phase 3 study design for the development of NTCD-M3 for the prevention of recurrence of Clostridioides difficile infections (CDI)
  • EMA endorses plans for the new patient-friendly NTCD-M3 capsule formulation

Brighton, United Kingdom – 7th September 2022 – Destiny Pharma plc (AIM: DEST), a late-stage clinical biotechnology company focused on the development of novel products to prevent life-threatening infectious diseases, is pleased to announce that it has received positive feedback from the European Medicine Agency (EMA) 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 (Marketing Authorisation Application) 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 (a study which is used to measure the potential impact of a drug on the heart function) for NTCD-M3 development programme

With EMA’s feedback received, Destiny Pharma is now focused on finalising the manufacturing and formulation of NTCD-M3 clinical trial material and on the detail of the global Phase 3 study with the aim of enrolling the first patient in the USA and potentially in Europe/rest of the world, towards the end of 2023. The Company is currently seeking partners to co-fund the Phase 3 clinical programme and take responsibility for the approval and commercialisation of NTCD-M3.

Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said:

“NTCD-M3 is a unique microbiome product being a single strain of non-toxigenic Clostridioides difficile. This targeted mode of action differentiates it from FMT (faecal microbiota transplantation) or other multiple strains or consortia microbiome products and NTCD-M3 also has advantages from a safety and longer-term risk perspective. Importantly, the NTCD-M3 strain only transiently colonises the patient’s intestine which means it protects from CDI while allowing the normal microbiome to be rebuilt after antibiotic treatment. Additionally, NTCD-M3 delivers an impressive efficacy with recurrence rates reduced to around 5% when used immediately after the antibiotic treatment for CDI has been completed. As a physician, being able to prevent patients with CDI to go down the path of multiple recurrence is truly a game changer for the treatment of this disease.”

Dr. Mark Wilcox, Head of Research and Development in Microbiology at the Leeds Teaching Hospitals, commented:

“Early model and clinical trial data show that NTCD-M3 can effectively block the action of pathogenic C. difficile strains and so reduce the risk of recurrent CDI.  The results of the forthcoming Phase 3 trial are eagerly awaited to confirm the effectiveness of this non-antibiotic approach to reducing the risk of recurrent C. difficile infection.”

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 (Biological Licence Application) by the FDA in the US for 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 (CDC), 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.

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 / Abigail Kelly / 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

Stern IR – USA
Lilian Stern / Janhavi Mohite
+1-212-362-1200

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-COVTM, 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.

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