Destiny Pharma announces research collaboration with the University of Southampton targeting infections in diabetic foot ulcers and cystic fibrosis

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

Destiny Pharma announces research collaboration with the University of Southampton targeting infections in diabetic foot ulcers and cystic fibrosis

Collaboration to investigate potential antimicrobial candidates from the Company’s XF drug platform against infections associated with biofilms

Brighton, United Kingdom – 1 November 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, that addresses the global problem of antimicrobial resistance (AMR), today announces it has been jointly awarded a National Biofilms Innovation Centre (NBIC) funded research collaboration with the University of Southampton. The project is intended to examine the use of the Company’s novel XF compounds to prevent, control, and eradicate chronic clinical infections with underlying biofilm involvement, such as those in diabetic foot ulcers and cystic fibrosis.

There is a significant unmet medical need in both the treatment and management of biofilms which can cause and exacerbate serious infections. Destiny Pharma’s XF compounds have already shown the potential to eradicate bacteria, such as MRSA, within a biofilm. The NBIC funded collaboration plans to expand on this data using laboratory and clinical microbial biofilm models and the expertise of the team at the University of Southampton’s Faculty of Environmental and Life Sciences, who have established ex vivo biofilm model systems and access to clinical infection samples that will be utilised in the collaboration. Financial terms of the collaboration have not been disclosed.

Professor Jeremy Webb, Co-Director of National Biofilms Innovation Centre (NBIC), commented:

“Destiny Pharma’s XF series show exciting promise and activity against bacterial biofilms. The NBIC funding will be used to accelerate the development of these compounds using clinically relevant biofilm models for chronic wound infections, including diabetic foot ulcers and within cystic fibrosis respiratory infection, to fill an important need in the treatment of antibiotic tolerant infections.”

Neil Clark, Chief Executive Officer of Destiny Pharma, added:

“We are excited to collaborate with the expert team at the University of Southampton. The collaboration will further explore the utility of our XF drug platform in the treatment of infections involving biofilms, especially in relation to diabetic foot ulcers and cystic fibrosis. As we have previously commented, biofilms represent a significant barrier to antimicrobial treatment and this collaboration may help us identify additional clinical candidates that are safe, effective and with a significantly reduced level of antimicrobial resistance.”

Biofilms are recognised as a key factor in the inability of antibiotics (and other antibacterial agents) to successfully treat infections. The formation of bacterial biofilms is implicated in the development of cystic fibrosis pneumonia, diabetic foot ulcers, dental caries and infections associated with indwelling medical devices, (e.g. hip implants and catheters). In the US, 1.7 million biofilm-related infections, (e.g. urinary tract, surgical, respiratory and circulatory infections) are annually reported (Centers for Disease Control and Prevention Report, 2007). The annual estimation of the cost of biofilm infections in the US is $94 billion, while annual biofilm-related healthcare-associated infections cost the NHS £1 billion p.a.

For further information, please contact:

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

National Biofilms Innovation Centre (NBIC)
Razwana Quadir, Communications Manager
R.Quadir@soton.ac.uk
+44 (0)23 8059 4446

University of Southampton
Press and Public Relations
press@southampton.ac.uk
+44 (0)23 8059 3212

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000

finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

About XF-73

XF-73 is a synthetic anti-microbial active against all tested Staphylococcus aureus strains, including drug resistant strains. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to cell death. XF-73 has already been through five successful Phase I/IIb clinical trials showing rapid antibacterial action.

XF-73 is indicated for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are particular groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.

About biofilms and fungal infections

Biofilms are an increasing problem that are poorly treated by current drugs. They act as a protective barrier for bacteria and have been traditionally associated with indwelling medical devices (for example, heart valves and joint replacements), and invasive medical devices (for example, catheters and endoscopes). It is now acknowledged that biofilms have a major involvement in bacterial vaginosis, urinary tract infections, middle-ear infections, gingivitis, corneal infections and more lethal diseases, such as endocarditis and cystic fibrosis. More recently it has been noted that bacterial biofilms may impair cutaneous wound healing and reduce topical antibacterial efficiency in healing or treating infected skin wounds, including diabetic foot ulcers.

Whilst several fungal species have been implicated in cystic fibrosis associated pneumonia, their role as spectators or contributors to the pathogenesis remains to be elucidated. Exploring the anti-fungal properties of the XF-platform on fungal species present in clinical samples of sputum from CF patients may shed light on that role.

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit

https://www.destinypharma.com

About National Biofilms Innovation Centre (NBIC)

NBIC is the central hub where academia, industry, government, and public policy come together to tackle the global challenges biofilms present, through a forward-thinking, collaborative and interdisciplinary approach. Funded by the Biotechnology and Biological Sciences Research Council (BBSRC), Innovate UK and Hartree Centre, our mission is to establish a network of research and innovation capacity in order to catalyse partnerships with industry in the study of biofilms to achieve breakthrough innovations and impact – from industry products and solutions to services and spinouts. The four core partners are the University of Southampton, the University of Edinburgh, the University of Liverpool and the University of Nottingham. They have now been joined by an additional 27 universities and over 60 industry partners in the aim to prevent, detect, manage and engineer solutions in biofilms.

www.biofilms.ac.uk

About the University of Southampton

Among the top 100 institutions in the world (QS University Rankings, 2019), the University of Southampton drives original thinking, turns knowledge into action and impact, and creates solutions to the world’s leading challenges, from cancer to cybersecurity. The University’s academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 24,000-strong community of exceptional students, from over 135 countries globally. With a firm foundation of academic and research excellence, Biological Sciences at the University has a strong focus on finding solutions to contemporary challenges with real-life benefits, supporting and inspiring bio scientists of the future and by working across various disciplines with other universities, private industry and the public sector.

http://www.southampton.ac.uk

Directorate Change

THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON THE PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

 Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

Directorate Change

 Destiny Pharma appoints Shaun Claydon as Chief Financial Officer

Brighton, United Kingdom – 25 October 2018 Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, which address the global problem of antimicrobial resistance (AMR), today announces the appointment of Shaun Claydon to the Board as the Company’s Chief Financial Officer (CFO) and Company Secretary with immediate effect. Shaun succeeds Simon Sacerdoti who has chosen to step down as CFO, Company Secretary, and a member of the Board to pursue other business opportunities. Mr Sacerdoti, having successfully helped the Company through its successful Initial Public Offering on AIM in 2017, will remain an employee of Destiny Pharma until the end of the year to ensure an orderly handover, at which point he will continue to assist the Board in a consultancy capacity.

Mr Claydon is an accomplished corporate financier and Chartered Accountant with over 16 years board level experience within the biotechnology sector. He has extensive experience of delivering financial and operating results and recently served as CFO of Creabilis, a venture backed clinical stage specialty pharmaceutical company focused on dermatology treatments, during which he led a $150 million sale of the business to Sienna Biopharmaceuticals.

Prior to that he was CFO and Chief Operating Officer (COO) of Orteq Sports Medicine, a medical device company and world leader in the field of biodegradable polymer technologies. Mr Claydon was also responsible for origination and execution of domestic and international mergers and acquisitions as a director in HSBC’s Investment Banking division. Mr Claydon holds a BA in Economics from the University of Leeds, UK.

Sir Nigel Rudd, Chairman of Destiny Pharma, commented:

“On behalf of the Board, I wish to express our gratitude to Simon for his valuable contribution to Destiny Pharma over the past three years, including being an integral member of the team to execute a successful IPO last year. We are pleased to welcome Shaun to Destiny Pharma. His broad and relevant biotechnology sector experience as both CFO and COO will prove invaluable to the Company as we execute our clinical strategy and next stages of growth.”

The following information is disclosed pursuant to Schedule Two paragraph (g) of the AIM Rules for Companies. Shaun Claydon, aged 50, has been a director of the following companies during the five years preceding the date of this announcement:

Current directorships

Past directorships

Distil plc

Orteq Limited

 

Orteq Inc

Save as set out above there are no further disclosures pursuant to Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

Mr Claydon has no beneficial interest in the ordinary shares of the Company.

For further information, please contact:

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

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000

finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

Destiny Pharma announces appointment of Chief Medical Officer

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

Destiny Pharma announces appointment of Chief Medical Officer

Dr Jesús González brings extensive experience in the clinical development of anti-infectives, as the Company prepares to initiate a Phase 2b trial for lead asset

Brighton, United Kingdom – 26 September 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, which address the global problem of antimicrobial resistance (AMR), today announces the appointment of Jesús M González Moreno, M.D. as Chief Medical Officer (CMO) of the Company, with immediate effect.

Dr González is an infectious disease expert with more than 11 years’ experience of working within global pharmaceutical and biotechnology companies to design, coordinate and execute clinical development plans for anti-infective drug candidates. His experience spans from early and late clinical development to medical affairs and preparation for marketing authorisation submissions. Dr González most recently served as Global Clinical Development Director at TiGenix SAU in Spain, where he was responsible for the overall development strategy for Cx611, a stem cell treatment for sepsis secondary to community-acquired pneumonia, including the design and implementation of its Phase 1b/2a clinical trial.

Prior to that Dr González worked at Basilea Pharmaceutcia in Switzerland as Medical Science Liaison team leader, responsible for the global medical plan for anti-infectives. Dr González also held a number of medical director roles at AstraZeneca within their Infection division, where he contributed to the development strategy, was responsible for the coordination and implementation of Phase 2-3 trials for novel antibiotics and collaborated in regulatory fillings globally. Additionally, Dr González worked as Regional Director of Medical Affairs in Antibiotics & Antifungals for Merck&Co and MSD, responsible for the development and implementation of regional medical and scientific strategy for these anti-infectives in Europe, Middle East, Africa, and Canada.

Dr González is a licensed physician with a medical doctor degree from the Universidad Autónoma de Madrid, Spain. Dr González also received a master’s degree in Statistics and Study Design for Research in the Health Sciences from the Universidad Autónoma de Barcelona. Dr González completed his postdoctoral fellowship in emerging and re-emerging infectious diseases at the Uniformed Services University of the Health Sciences, Department of Defence, Maryland, US.

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
I am delighted to welcome Dr González to the senior management team as our new Chief Medical Officer. Jesús brings a wealth of knowledge and experience in the clinical development of anti-infective drugs, from early stage development through to regulatory submission. Dr González’ proven track record will be invaluable to Destiny Pharma as we continue to progress the development of our novel XF drugs to address antimicrobial resistance and I look forward to working closely with him.”

For further information, please contact:

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

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000

finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

Directorate Change

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

Directorate Change

New Chairman Appointment

Brighton, United Kingdom – 6 September 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, which address the global problem of antimicrobial resistance (AMR), announces that Sir Nigel Rudd is stepping down as Chairman and a member of the Board after serving eight years and having made his first investment in the Company in 2003.

Nick Rodgers, Non-Executive Director of Destiny Pharma, will become Chairman following Sir Nigel’s departure on 31 December 2018. Nick has considerable Board experience in both public and private growth companies, particularly those in the life science sector, as well as a background as a successful corporate financier and investment banker. Nick is currently Chairman of SEHTA, one of the largest health technology networking organisations in the UK. Prior to this, he was Non-Executive Director and then Chairman of Oxford Biomedica plc, a leading gene-based biopharmaceutical company.

Sir Nigel Rudd, Chairman of Destiny Pharma, commented:
“It has been a privilege to be part of Destiny Pharma for the past 15 years. During this time, the Company has experienced transformative growth underpinned by the discovery of the XF drug platform which has the potential to address the global issue of antimicrobial resistance. I am confident in the outlook of the business, with a strong management team in place to deliver against the Company’s strategic goals.”

Neil Clark, Chief Executive Officer of Destiny Pharma, added:
“On behalf of Destiny Pharma, I would like to thank Sir Nigel for his considerable contribution to the Company which has grown significantly as a result of his extensive experience, specialised industry knowledge and track record of developing early stage companies. We wish Sir Nigel all the very best for the future. On behalf of Destiny Pharma, I also welcome Nick as Chairman and look forward to continuing to work closely with him as we advance our XF-drug platform through clinical development.”

For further information, please contact:

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

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000

finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

About XF-73
XF-73 is a synthetic anti-microbial active against all tested Staphylococcus aureus strains, including drug resistant strains. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to cell death. XF-73 has already been through five successful Phase I/IIb clinical trials showing rapid antibacterial action.

XF-73 is indicated for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are particular groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

Destiny Pharma announces positive data from XF-73 Phase 1 skin irritation study

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

Destiny Pharma announces positive data from XF-73 Phase 1 skin irritation study

Positive data supports product opportunities for XF-73 in dermal infection indications

Data also supports planned Phase 2 clinical trial of XF-73 nasal gel for the prevention of post-surgical infection

Brighton, United Kingdom – 26 July 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, which address the global problem of antimicrobial resistance (AMR), today announces positive data from the first of two Phase 1 safety clinical studies of XF-73, examining the drug’s potential to cause dermal irritation. XF-73 is the Company’s lead candidate for the prevention of post-surgical staphylococcal infections.

The positive results support the potential of XF compounds in dermal infection indications and also reinforce the target product profile of XF-73 in advance of it entering a Phase 2 clinical trial under the US Food and Drug Administration (FDA) Qualified Infectious Disease Product (QIDP) and Fast Track designations. The Phase 2 study will examine a nasal gel formulation of the drug for the prevention of post-surgical infections, which is on plan to report data in H2 2019.

The Phase 1 clinical study, completed in the US under an Investigational New Drug (IND) from the FDA, demonstrated that XF-73 in aqueous solution, at high concentrations, when applied daily for five days to intact and abraded skin (by tape stripping) has a similar irritancy potential to water under occluded (covered) conditions in a shorter version of an industry standard cumulative irritancy dermal safety study. The volunteer clinical trial was blinded and placebo controlled with pharmacokinetic sampling.

This finding on abraded skin, combined with the lack of systemic absorption, (i.e. no XF-73 was seen in blood samples taken throughout the study), also supports the profile of XF-73 (and potentially other XF drugs) as new treatment options for dermal infections.

Neil Clark, Chief Executive of Destiny Pharma, commented:

“We are pleased to successfully complete this Phase 1 study, confirming the safe profile demonstrated to date in all other XF-73 clinical studies. We are also excited that the abraded skin data supports the potential for the XF platform in treating difficult skin infections and we will now assess our drug development options in that therapeutic area.”

These study results add to the existing strong safety and efficacy dataset already established by Destiny Pharma in preparation for the Phase 2 planned to report data in H2 2019 to assess the effectiveness of XF-73 nasal gel in significantly reducing nasal Staphylococcus aureus prior to surgery compared to placebo. A second Phase 1 study with the XF-73 nasal gel formulation will be completed later in 2018 in a similar skin irritation potential safety volunteer trial. On completion of this study, XF-73 nasal gel will be ready to commence the Phase 2 trial.

Destiny Pharma will now finalise a programme to develop an XF drug targeting the prevention and/or treatment of specific dermal infections. As with all XF drugs, the potential target product profile will include a safe, rapid kill of relevant bacteria whilst generating low or no AMR due to the unique mechanism and the rapidity of the XF mode of action.

For further information, please contact:

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

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000

finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

About XF-73

XF-73 is a synthetic anti-microbial active against all tested Staphylococcus aureus strains, including drug resistant strains. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to cell death. XF-73 has already been through five successful Phase I/IIb clinical trials showing rapid antibacterial action.

XF-73 is indicated for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are particular groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://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.

Posting of Accounts and Notice of AGM

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

Posting of Annual Report and Accounts, and Notice of AGM

Brighton, United Kingdom – 23 April 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), announces that the annual report and accounts of the Company for the year ended 31 December 2017 (“Annual Report”), and the notice of the Company’s Annual General Meeting (“AGM”) are now available on the Company’s website at www.destinypharma.com

The Annual Report will be posted to shareholders today.

The AGM is to be held at 10.00am on 31 May 2018 at the offices of FTI Consulting LLP at 200 Aldersgate, London EC1A 4HD.

Clinical update

THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON THE PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

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

Destiny Pharma announces update on clinical programme for lead drug candidate XF-73

Started recruiting subjects in latest Phase 1 dermal study under US IND

FDA discussions have clarified overall clinical trial plans for XF-73

Phase 2b study on track to announce results in H2 2019

Brighton, United Kingdom – 12 April 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), today announces an update on the scope and timing of the XF-73 (exeporfinium chloride) Phase 1 and Phase 2b clinical trial programmes following discussions with the US Food and Drug Administration (FDA). This process is in line with the Company’s strategy set out at the time of the placing and admission to AIM and the current status is summarised below:

  • As previously announced, in February 2018, Destiny Pharma opened an Investigational New Drug (IND) application and, in March 2018, was awarded Fast Track designation for the XF-73
  • Destiny Pharma announces today that a Phase 1 dermal safety study, looking at potential skin irritation of XF-73 solution in up to 30 subjects, has started in a specialist US based unit
  • The FDA has clarified that only one additional Phase 1 dermal safety study,looking at skin irritation of XF-73 nasal gel in up to 30 subjects ,has to be completed before the planned Phase 2b trial can start
  • Destiny Pharma is pleased to note that the FDA confirmed that the additional, larger, Phase 1 dermal safety study, looking at the potential for skin sensitisation of XF-73 nasal gel in 200 subjects, does not need to be completed before the Phase 2b study and is only required in advance of the start of Phase 3 trials. Destiny Pharma plans to complete this larger skin sensitisation study in parallel with the Phase 2b in 2019
  • With these clarifications Destiny Pharma is now finalising plans to start the Phase 2b trial. This trial will assess the efficacy of XF-73 against placebo in the nasal decolonisation of Staphylococcus aureus in approximately 150 patients prior to their undergoing hospital surgical procedures. The Company is on track to announce Phase 2b results in the second half of 2019, with the aim of delivering a Phase 3 ready package by the end of 2019

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:

“We are very pleased to get this confirmation from the FDA on the clinical pathway for our lead asset, XF-73. As we set out at the time of our admission to AIM, once the IND and Fast Track designation were confirmed we were expecting to be able to parallel track some of the standard Phase 1 studies and our Phase 2b study based on the existing safety profile of XF-73, and the FDA has now confirmed that this approach is appropriate. Over 160 subjects to date have been dosed with this potentially breakthrough antibacterial drug as a nasal formulation with no significant issues. The Company is well funded and the team at Destiny Pharma remains fully focused on delivering the agreed clinical plan.”

XF-73, Destiny Pharma’s lead asset, is a first-in-class drug candidate, 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 burden in the hospital setting.

 

For further information, please contact:

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

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000

 finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

 

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://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.

 

 

Audited results for the year ended 31 December 2017

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

Audited results for the year ended 31 December 2017

Well funded and on track to deliver Phase 2b headline data in H2 2019 for lead
asset, XF-73,a novel anti-microbial

 Brighton, United Kingdom – 12 April 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), announces its audited financial results for the year ended 31 December 2017.

Financial highlights

  • Successfully completed placing and admission to AIM, raising £15.3 million
  • Additional £3.0 million invested by China Medical Systems Holdings Ltd
  • Strong cash position with cash and term deposits at 31 December 2017 of £16.7 million (2016: £1.5 million)

Operational highlights

  • China and Asia regional development and collaboration agreement signed with China Medical System Holdings Ltd (CMS)
  • Patent portfolio strengthened with the grant of the South Korean XF-biofilm patent
  • Board and executive management team strengthened with the appointment of Neil Clark as CEO, Dr Bill Love, founder of the Company, as Chief Scientific Officer and Dr Huaizheng Peng, General Manager of International Operations at CMS, as Non-executive Director

Post-period highlights

  • US Investigational New Drug (IND) application opened for XF-73
  • US Food and Drug Administration (FDA) Fast Track designation granted for XF-73
  • First subject enrolled in a Phase 1 dermal safety study for XF-73
  • Clarification, through dialogue with the FDA, of the Phase 1 and Phase 2b clinical trials programme – further details of which can be found in a separate announcement released this morning
  • Patent portfolio expanded with the grant of Canadian XF-biofilm patent

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:

“In 2017, we built on the existing strong foundations of Destiny Pharma, successfully completing the placing admission to AIM which raised significant additional capital to progress our pipeline through the planned clinical studies, and executing a key strategic partnership in Asia with China Medical Systems to help realise our commercial aspirations.

“In 2018, progress has continued to be been strong for our lead candidate, XF-73, with the opening of the IND and award of Fast Track designation. Subsequent discussions with the FDA have clarified the clinical pathway for XF-73. We remain on track to deliver Phase 2b results in H2 2019 as part of a Phase 3 ready package. Importantly, our market analysis continues to support the clinical need and commercial opportunity for XF-73 in the prevention of post-surgery hospital infections, such as MRSA, which is estimated to be over a $1 billion market opportunity.

“The Company is well funded following the placing at the time of admission to AIM and, whilst our main focus is on our lead asset, we are also looking to progress our earlier pipeline and develop our collaboration with China Medical Systems. There is continuing international support for the development of novel anti-infective drugs that address the issue of anti-microbial resistance and Destiny Pharma’s unique platform is very well-positioned to meet this global need.”
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The full text of the announcement may be found here.

Destiny Pharma announces FDA Fast Track Designation for lead clinical candidate, exeporfinium chloride (XF-73)

THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON THE PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN. 

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

Destiny Pharma announces FDA Fast Track Designation for lead clinical candidate, exeporfinium chloride (XF-73)

Brighton, United Kingdom – 15 March 2018 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), today announces that its lead clinical candidate exeporfinium chloride (XF-73) has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA). This follows the FDA’s acceptance in February 2018 of an Investigational New Drug (IND) Application by the Company for the potentially ground-breaking drug.

Fast Track Designation is one of a package of measures and incentives available under the FDA’s Qualifying Infectious Disease Product (QIDP) programme, set up to encourage development of novel ant-infective drugs. XF-73 was awarded QIDP status in October 2015.  Fast Track designation is intended to expedite the potential availability of a drug to patients which, in the view of FDA, has promise in treating a serious or life-threatening condition and to fulfil an unmet medical need.

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:

“We are pleased to have received Fast Track designation from the FDA for XF-73. This represents a further recognition of the potential for the drug and the need for an effective prevention for post-surgical staphylococcal infections, such as MRSA, that can result in significant complications for patients and significantly increased costs for hospitals. On our analysis of published data, there are approximately 40 million surgeries per annum, in the USA alone, where the patient is at risk of a post-surgical infection, We look forward to continuing our clinical development of XF-73 which remains on track and we expect Phase II data in 2019.”

XF-73 has been developed from Destiny Pharma’s novel, antimicrobial “XF” drug platform. Unlike traditional antibiotics, XF drugs have not been seen to generate bacterial resistance in industry-standard microbiology tests conducted to date and therefore have significant potential to address the global threat of AMR. XF-73 has been shown to kill bacteria very rapidly and therefore may be an effective new treatment in the reduction of bacterial infections in hospital patients, including those caused by MRSA.

MRSA is one of the most prominent superbugs and a major cause of hospital associated infection and featured in the WHO’s ‘most dangerous’ list of superbugs published in 2017. The WHO followed US and European guidelines in 2016 by recommending the screening and decolonisation of MRSA and all strains of Staphylococcus aureus in pre-surgical patients undergoing high risk surgeries in a step designed to help prevent such infections. XF-73 is targeted to address this important clinical need.

For further information, please contact:

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

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

Cantor Fitzgerald Europe (Nominated Adviser and Broker)
Philip Davies / Will Goode, Corporate Finance
+44 (0)20 7894 7000

About XF-73

XF-73 is a synthetic, anti-microbial drug which has demonstrated potency against all Staphylococcus aureus strains, including drug resistant strains (MRSA), tested to date. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to bacterial death. XF-73 has already been through five successful Phase I/IIa clinical trials showing rapid antibacterial action.

XF-73 is indicated for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are particular groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com