06 Nov 2019 – Destiny Pharma to present at the World Anti‐Microbial Resistance Congress 2019

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

Destiny Pharma to present at the World Anti‐Microbial Resistance Congress 2019

Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti‐microbial drugs that address clear commercial opportunities and also address the global problem of anti‐microbial resistance (AMR), announces that Neil Clark, Chief Executive Officer of Destiny Pharma, will present on the potential of the Company’s XF Drugs to address the threat of AMR at the World Anti‐Microbial Resistance Congress on 7‐8 November, 2019 in Washington D.C, US.

About World Anti‐Microbial Resistance Congress
The World Anti‐Microbial Resistance Congress has been the only commercially focused conference globally of its kind, since 2015. Launched during the release of key reports such as the AMR Review and a Scientific Roadmap for Antibiotic Discovery, the World AMR Congress has brought attention to the threats of this emerging crisis to the global healthcare system. This AMR focused event attracts 200 speakers and over 600 attendees from over 40 countries.

For further information, please contact:

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

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

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

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development and commercialisation of novel medicines from its XF Platform that represent a new approach to the treatment of infectious disease. The company’s lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post‐surgical hospital infections including MRSA. The XF drug candidates are being developed 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 World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

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 seven successful Phase I/II clinical trials showing it is safe and delivers a rapid antibacterial action. In standard microbiology studies XF drugs have demonstrated a unique no/low resistance profile that means that XF compounds have the potential to deliver novel drugs that are clearly differentiated from traditional antibiotics where resistance limits their utility. XF‐73 is being studies 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.

16 Oct 2019 – Positive Phase 1 results published in journal

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

Positive results published from an independent (US National Institute of Health) XF-73 phase 1 clinical trial in a peer reviewed journal


The publication in the Journal of Global Antimicrobial Resistance concluded that application of a nasal gel formulation of XF-73 in healthy volunteers was safe, well tolerated and generated minimal side effects

Treatment with XF-73 was also associated with a rapid reduction in nasal Staphylococcus aureus in all subjects; nasal carriage of the bacteria is the source of the majority of post-surgical bacterial infections

The same nasal formulation is being used in the Company’s phase 2b trial assessing the microbiological effect of XF-73 on nasal S. aureus in patients scheduled for cardiac surgery and at high risk of post-operative S.aureus/MRSA infection; headline results continue to be expected in mid-2020
 

Brighton, United Kingdom – 16 October 2019 Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs that address clear commercial opportunities and also address the global problem of antimicrobial resistance (AMR), notes the publication of results from a positive phase 1 clinical study in 60 healthy US volunteers using a nasal gel formulation of its lead drug, XF-73 (exeporfinium chloride), in the peer reviewed Journal of Global Antimicrobial Resistance [Yendewa GA, Griffiss JM, Jacobs MR et al; J. Glob. Antimicrob. Resist. 2019 Oct 7. pii: S2213-7165(19)30250-4. doi: 10.1016/j.jgar.2019.09.017]. The headline results from this study were previously announced by Destiny Pharma on 5 September 2016.

The reported US study was independently conducted and sponsored by the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health (NIH). In addition to the study reporting a favourable safety and local tolerability profile of the nasal gel formulation (the primary objective), the study also noted, as expected, that exposure to XF-73 produced a rapid reduction in levels of nasal S. aureus in all subjects.

Destiny Pharma is initially developing a nasal gel formulation of XF-73 as a novel therapy to prevent post-surgical infection, including those from methicillin resistant S. aureus (MRSA), as nasal carriage is the source of >80% of S.aureus/MRSA post-surgical bacterial infections. The Company is currently conducting a 200 patient multi-centre, randomised, blinded, placebo-controlled phase 2b study of a single concentration of XF-73 nasal gel. This is to assess the anti-staphylococcal effect of XF-73 on S. aureus nasal carriage in US and European patients scheduled for cardiac surgical procedures deemed to be at high risk of post-operative S. aureus infection. Headline results from the trial are anticipated in mid-2020.

Neil Clark, CEO of Destiny Pharma, commented:
“The full results from this positive phase 1 clinical study, independently conducted and sponsored by the NIH, underscores our confidence in the potential of XF-73 as a novel treatment to prevent the occurrence of post-surgical S. aureus bacterial infections which is a significant commercial opportunity. Importantly, there is no evidence to date suggesting that XF-73 causes bacterial resistance which is in contrast to current preventative treatments such as the application of the antibiotic mupirocin, which the use of is increasingly blunted by the rising incidence of resistant strains of S. aureus. We look forward to reporting headline data in mid-2020 from our ongoing 200 patient phase 2b trial that is assessing the ability of XF-73 to reduce nasal levels of S. aureus in patients at high risk of infection that are undergoing surgery.”

Abstract in full
Yendewa GA, Griffiss JM, Jacobs MR etc al; J. Glob. Antimicrob. Resist. 2019 Oct 7. pii: S2213-7165(19)30250-4. doi: 10.1016/j.jgar.2019.09.017

OBJECTIVES:
There is conflicting data on the success of mupirocin as an effective decolonizing regimen for Staphylococcus aureus (SA) carriage, in part due to increasing drug resistance. This multi-center, randomized, open-label, prospective phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial drug with rapid intrinsic activity against SA.

METHODS:
The study was conducted in 2 dosing cohorts and enrolled 60 healthy adults. In Part 1, 8 non-SA carriers were randomized to 2 groups of 4 subjects in each arm and were treated with the new formulations of XF-73 in concentrations of 0.5 mg/g 2% gel and 2 mg/g 2% gel, respectively. In Part 2, 52 healthy persistent SA carriers were randomized to 4 groups of 13 subjects in each arm and were treated with three different concentrations of XF-73 (0.5 mg/g 2% gel, 2 mg/g 2% gel and 0.5 mg/g 4% gel) or a 4% viscosified placebo gel, respectively. Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies were performed. Anti-staphylococcal activity was assessed as the presence or absence of SA and by quantification of the level of colonization using a semi-quantitative scale (SA score).

RESULTS:
56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population. There was no measurable systemic absorption of XF-73 from nasal application. Treatment with XF-73 was associated with a rapid diminution in the SA scores in all subjects. The most common treatment emergent adverse events (TEAE) reported were rhinorrhea and nasal dryness (15.5% each in Part 1 and Part 2). TEAEs were mostly mild and resolved spontaneously.

CONCLUSION:
XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers. These findings support moving on to Phase 2 trials to further evaluate the efficacy of XF-73.

For further information, please contact:

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

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

finnCap Ltd (Nominated Adviser and Joint Broker)
Geoff Nash /Anthony Adams, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0)20 3705 9321

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development and commercialisation of novel medicines from its XF Platform that represent a new approach to the treatment of infectious disease. The company’s lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post-surgical hospital infections including MRSA. The XF drug candidates are being developed 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 World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

23 Sep 2019 – Directorate change

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

Directorate change

Brighton, United Kingdom – 23 September 2019 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs to address the global crisis caused by antimicrobial resistance (AMR), today announces that after 18 years on the Board, Joe Eagle a Non-Executive Director,  has decided to step down from the Board with effect from today. Joe was instrumental in the financing and strategic direction of Destiny as a private company and brought both pharmaceutical and marketing expertise to the development of the lead candidate, XF-73 for the prevention of post-surgical infections. A search for a replacement is underway.

Nick Rodgers, Chairman of Destiny Pharma, commented:

“On behalf of Destiny Pharma, I would like to thank Joe for his considerable contribution to the Company throughout its development as a private company and the transition onto the AIM market. Joe’s understanding of the pharma market and company development has been of great value to Destiny and I am sorry to see him go. We wish him all the very best for the future” .

Joe Eagle, Non-Executive Director, commented:

“I continue to believe that Destiny Pharma, through its XF platform, will develop unique and life-saving antimicrobials to counter the worldwide threat of antimicrobial resistance. I have seen the development of the Company from a small private enterprise to a successful, asset rich public company and wish all the members of the company every success with their future endeavours. It has been a privilege to work with you all.”

For further information, please contact:

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

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

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

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines from its XF Platform that represent a new approach to the treatment of infectious disease. The company’s lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post-surgical hospital infections including MRSA. The XF drug candidates are being developed 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 World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

10 Sep 2019 – Destiny Pharma awarded grant to fund a research collaboration with the University of Sheffield targeting ophthalmic bacterial and fungal infections

Destiny Pharma plc

(“Destiny Pharma” or “the company”)

Destiny Pharma awarded grant to fund a research collaboration with the University of Sheffield targeting ophthalmic bacterial and fungal infections

Collaboration to investigate antimicrobial candidates from the company’s XF drug platform against microbial infections of the eye

 Marks the fourth research grant Destiny Pharma has received in the past two years

Brighton, United Kingdom – 10 September 2019 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs to address the global crisis caused by antimicrobial resistance (AMR), today announces it has been jointly awarded a National Biofilms Innovation Centre (NBIC) grant to fund a research collaboration with the Sheffield Centre for Antimicrobial Resistance and Biofilms at the University of Sheffield. The project aims to establish the potential of two of the Company’s proprietary XF drug compounds, DPD-207 and XF-73, as novel treatments for drug-resistant, bacterial and fungal infections in a dynamic ex vivo eye model. NBIC’s stated aim is to establish a network of research and innovation capacity catalysing collaboration with industry in the study of biofilms to achieve breakthrough and innovation. Financial terms of the collaboration have not been disclosed.

Drug resistant bacteria and fungi pose a significant threat across a range of ophthalmic infections and can result in vision impairment and blindness. Many chronic eye infections, such as bacterial keratitis and lacrimal/periorbital infections, are caused by microbes aggregating to form a biofilm. These biofilms are difficult to treat with conventional antibiotics, a problem which is exacerbated by the rise of AMR. Destiny Pharma’s XF drugs have already demonstrated efficacy in killing bacteria located in biofilms in early clinical studies.

The global ophthalmic drugs market size is currently valued at approximately $30 billion. A significant proportion of this market is therapeutics for ocular infections, which the Company estimates to be worth over $1 billion.

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

We are excited to collaborate with the expert team at the University of Sheffield as we look to initiate our second research project in biofilms supported by the National Biofilms Innovation Centre. The project will explore the utility of our novel XF drug platform in the treatment of eye infections involving biofilms. Biofilms represent a significant barrier to antimicrobial treatment and this collaboration may help us identify additional clinical candidates for ocular indications in a billion-dollar market that are safe, effective and with a significantly reduced level of antimicrobial resistance. The project in part will further explore the potential of our lead drug, XF-73, which is also currently in Phase IIb clinical development for the prevention of post-surgical infections.”

Professor Peter Monk, Professor in the Department of Infection, Immunity and Cardiovascular Disease at Sheffield University Medical School, commented:

The Sheffield Centre for Antimicrobial Resistance and Biofilms (SCARAB) was established in 2017 using funding from Innovate UK to support the development of new antimicrobial agents to treat severe infections. The partnership with NBIC and Destiny Pharma allows us to test new compounds against biofilms growing in living tissues.

 

For further information, please contact:

Destiny Pharma plc

Neil Clark, CEO

Shaun Claydon, CFO

pressoffice@destinypharma.com

+44 (0)1273 704 440

FTI Consulting

Simon Conway / Victoria Foster Mitchell

destinypharma@fticonsulting.com

+44 (0) 20 3727 1000

finnCap Ltd (Nominated Advisor Joint Broker)

Geoff Nash /Kate Bannatyne, Corporate Finance

Alice Lane, Corporate Broking

+44 (0)20 7220 0500

WG Partners (Joint Broker)

Nigel Barnes / Claes Spång / Nigel Birks

+44 (0) 203 705 9330

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines from its XF Platform that represent a new approach to the treatment of infectious disease. The company’s lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post-surgical hospital infections including MRSA. The XF drug candidates are being developed 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 World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

About DPD-207 and XF-73

XF drug candidates, including DPD-207 and XF-73, are synthetic anti-microbial drugs that have demonstrated a unique no/low resistance profile against many drug resistant strains. By acting via a cell-surface mechanism, they affect bacterial membrane permeability and integrity, leading to rapid cell death. Destiny Pharma therefore believes the XF platform has the potential to deliver novel drugs that are clearly differentiated from traditional antibiotics where resistance limits their utility.

XF-73 has been through seven successful Phase I/IIa clinical trials, demonstrating safety and efficacy in delivering a rapid antibacterial action. XF-73 is currently in a Phase IIb clinical trial for the prevention of post-surgical staphylococcal infections. In the US alone, there are approximately 40 million surgeries per annum 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 predominately due to the nature of their surgery or procedure. 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 and is an opportunity with one billion-dollar peak sales.

DPD-207 differs in structure from XF-73 and has been chemically designed to carry an iron atom within the central porphyrin structure. This chemical modification has been made to potentially enhance the drug’s physico-chemical profile for ocular administration.

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.

The University of Sheffield

With almost 29,000 of the brightest students from over 140 countries, learning alongside over 1,200 of the best academics from across the globe, the University of Sheffield is one of the world’s leading universities. A member of the UK’s prestigious Russell Group of leading research-led institutions, Sheffield offers world-class teaching and research excellence across a wide range of disciplines. Unified by the power of discovery and understanding, staff and students at the university are committed to finding new ways to transform the world we live in. Sheffield is the only university to feature in The Sunday Times 100 Best Not-For-Profit Organisations to Work For 2018 and for the last eight years has been ranked in the top five UK universities for Student Satisfaction by Times Higher Education. Sheffield has six Nobel Prize winners among former staff and students and its alumni go on to hold positions of great responsibility and influence all over the world, making significant contributions in their chosen fields. Global research partners and clients include Boeing, Rolls-Royce, Unilever, AstraZeneca, Glaxo SmithKline, Siemens and Airbus, as well as many UK and overseas government agencies and charitable foundations.

02 Sept 2019 – Destiny Pharma XF Drug platform data to be presented at EuroBiofilms

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

 Destiny Pharma XF Drug platform data to be presented at EuroBiofilms

Data part of collaboration with Cardiff University to identify safe and efficacious compounds with a reduced anti-microbial resistance profile

Brighton, United Kingdom – 2 September 2019 – 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 data from its collaboration, ‘Evaluation of XF Drugs as Antibiotic Resistance Breakers’, with Cardiff University is being presented at the EuroBiofilms conference, in Glasgow, 3-6 September 2019.

The poster, entitled ‘Evaluation of the novel XF Drugs: Potent antibacterial drugs with Twin Mechanisms of Action’, is being presented by Dr Emma Board-Davies, Post-Doctoral Research Associate, School of Pharmacy and Pharmaceutical Sciences, Cardiff University. The data looks at the potency of Destiny Pharma’s product platform, including XF-73, XF-70 and DPD-207, against a range of the critical, infection causing bacteria.

The research programme, ‘Evaluation of XF Drugs as Antibiotic Resistance Breakers,’ is a two-year project examining the use of the Company’s novel XF drugs to prevent, control and eradicate life threatening bacteria or “superbugs” without generating resistance. It is funded by 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 at the beginning of 2019.

About EuroBiofilms
EuroBiofilms provides participants with a valuable forum for a fruitful scientific exchange in the field of microbial biofilms. An opportunity for scientists, clinicians and industry partners with an interest in biofilm-related problems to exchange novel information on clinical, environmental and basic elements of microbial biofilms.

For further information, please contact:

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

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

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

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines from its XF Platform that represent a new approach to the treatment of infectious disease. The company’s lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post-surgical hospital infections including MRSA. The XF drug candidates are being developed 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 World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit www.destinypharma.com

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 seven successful Phase I/II clinical trials showing it is safe and delivers a rapid antibacterial action. In standard microbiology studies XF drugs have demonstrated a unique no/low resistance profile that means that XF compounds have the potential to deliver novel drugs that are clearly differentiated from traditional antibiotics where resistance limits their utility.

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.

09 Apr 2019 – Audited Results for the year ended 31 December 2018

Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

 Audited results for the year ended 31 December 2018

 Well-funded and on track

Brighton, United Kingdom – 9 April 2019 – 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 2018.

Financial highlights

  • Strong cash position with cash and term deposits at 31 December 2018 of £12.1 million (2017: £16.7 million)
  • Increase in R&D expenditure to £3.5 million (2017: £0.8 million) due to planned clinical development costs

 Operational highlights

 XF-73 for prevention of post-surgical infections

  • Phase 2b protocol finalised and 200 patient study now starting April 2019
  • Results due around year-end 2019
  • US market research report confirms clinical need and attractive target product profile of XF-73 nasal – clear unmet need and payer support for proposed pricing supports large market potential
  • US Investigational New Drug (IND) application opened for lead clinical programme XF-73 nasal – a novel anti-microbial being developed as a preventative treatment
  • US Food and Drug Administration (FDA) Fast Track designation granted for XF-73
  • Clarification, through dialogue with the FDA, of the Phase 1 and Phase 2b clinical trials programme
  • Successful completion of required Phase 1 dermal safety studies to enable start of Phase 2b

Earlier pipeline and research grants

  • New dermal infection clinical programme initiated with XF-73 targeting diabetic foot ulcer infections
  • Award of two research grants in collaborations with Aston and Southampton Universities
  • Patent portfolio expanded with the grant of Canadian XF-biofilm patent

Corporate highlights

  • Board and executive management team strengthened with the appointment of Jesus Gonzales MD as Chief Medical Officer and Shaun Claydon as Chief Financial Officer

Post-period highlights

  • Award of UK China AMR grant of up to £1.6 million to examine XF compounds potential against dermal and ocular infections
  • UK government announces new 5 and 20 year plans to address AMR and to support novel drug development addressing AMR and improved financial incentives for companies bringing such new drugs to market
  • Nick Rodgers appointed as Chairman replacing Sir Nigel Rudd who stepped down after 15 years with the Company

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

“We have made significant progress in the first full year following our IPO in September 2017, delivering on key targets set out at the time, including a number of clinical development objectives, and the Company remains well funded to H2 2020.

“Our lead clinical candidate, XF-73 nasal is being developed as a preventative treatment reducing the carriage of Staphylococcus aureus with the intention of preventing post-surgical hospital infections; a $1 billion peak sales market opportunity. During April 2019 we will initiate the important Phase 2b clinical trial in this setting and will complete recruitment later this year.

Whilst our main focus is on our lead asset we are also continuing to progress our earlier XF pipeline having won three grants to support this workstream. 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 well-positioned to meet this global need.”

This announcement has been released by Neil Clark, CEO, on behalf of the Company.

The full text of the announcement may be found here.

27 Mar 2019 – MedPharm to develop new XF-drug formulations

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

Destiny Pharma appoints MedPharm to develop new XF‐platform drug formulations

MedPharm will develop potential XF‐platform formulations as treatments for dermal and ocular infections

Brighton, United Kingdom ‐ 27th March 2019 ‐ Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Company’s novel XF‐platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti‐microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using
sophisticated in vitro models to de‐risk development programmes.

The XF platform has already delivered a Phase 2 ready candidate, XF‐73 nasal gel, for the prevention of post‐surgical infections, that will begin Phase 2b testing in 2019. MedPharm will develop new formulations containing Destiny Pharma’s XF‐platform compounds for the treatment of a number of topically treated infections, including diabetic foot ulcers and ophthalmic infections.  MedPharm is a well‐established, global leader in topical product development with a track record in developing a wide variety of formulations, from early concept stage through clinical development to full product approval.

Neil Clark, CEO of Destiny Pharma commented:
“We are pleased to be working with MedPharm and using their globally recognised expertise to develop effective, patient‐friendly formulations of XF and DPD drugs from our novel antimicrobial XF‐platform. There is an unmet medical need for novel antiinfectives that address dermal and ocular infections with a significantly reduced level of antimicrobial resistance. We look forward to developing improved, targeted formulations with MedPharm to take into future pre‐clinical and clinical studies.”

Eugene Ciolfi, President & CEO of MedPharm commented:
“MedPharm are very excited to be a part of this project and working in close collaboration with Destiny Pharma to address this unmet medical need. Our rigorous methodology, incorporating our novel and world leading in vitro performance testing, will ensure that we deliver fully optimised formulations and de‐risk these important development programmes.”

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, 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 ECM
+44 (0)20 7220 0500

MedPharm Ltd
Jeremy Drummond, SVP Business Development
Yasmeen Hussain, Marketing
business.development@medpharm.com

Ramarketing
Celine Goodier
celine@ramarketingpr.com

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines from its XF platform 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 MedPharm
MedPharm is the world’s leading contract provider of topical and transdermal product design and formulation development services. MedPharm are experts at reducing risk and accelerating development times for generic and proprietary pharmaceutical customers through their unique, cost‐effective and industry‐leading performance testing performance testing models. Well established as the global leaders in dermatology, nail, mucosal membrane, and transdermal product development, MedPharm can also offer innovative solutions for ophthalmic and airway preparations recognised for their scientific rigour by regulators and investors. MedPharm has fully established centres of excellence in Durham, USA and Guildford, UK. For further information, please visit https://www.medpharm.com.

22 Mar 2019 – Notice of Full Year Results

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”)

Notice of Full Year Results

Brighton, United Kingdom – 22 March 2019 – 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), will announce its financial results for the year ended 31 December 2018 on Tuesday 9 April 2019.

A presentation for analysts will be held at 9:30am BST on Tuesday 9 April 2019 at the office of FTI Consulting, 200 Aldersgate Street, London EC1A 4HD.

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, 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

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 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.

https://www.southampton.ac.uk