01 February 2022 – Positive data in XF-73 Dermal study with NIAID

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

Positive results in XF-73 Dermal safety study from ongoing agreement with US Government’s NIAID

Brighton, United Kingdom, 1 February 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces the successful completion of a preclinical safety study with a novel XF-73 dermal formulation.

The study was the first of two preclinical safety studies of its lead XF-73 Dermal formulation carried out as part of a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health. The study met its objectives and generated positive data, which clears the path for its progression into the second and final clinically‑enabling regulatory safety study. Both studies are being conducted through NIAID’s suite of preclinical services.

Destiny Pharma is developing a novel formulation of XF-73 (XF-73 Dermal) for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers.

Destiny Pharma will continue to work with NIAID to complete this preclinical safety package that will support future clinical development of XF-73 Dermal in serious wound infections. The study is planned to complete in 2022.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased with the encouraging data from our novel XF-73 dermal formulation which is aimed at meeting a clear clinical need in a large market where peak product sales could reach half a billion US dollars. This programme is well placed to deliver a second clinical candidate from our XF platform following the excellent Phase 2 clinical results generated for the XF-73 nasal gel for the prevention of post-surgical infections caused by Staphylococcal aureus.”

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark, Manel Mateus, Vici Rabbetts
DestinyPharma@optimumcomms.com
+44 (0) 208 078 4357
www.optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0) 207 220 0500

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0

About Destiny Pharma

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

For further information, please visit  www.destinypharma.com

About XF-73

XF-73 is the lead drug candidate from Destiny Pharma’s XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. XF-73 has been awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the US FDA.

Dermal Infections

XF-73 is being developed as a new treatment for serious dermal infections such as diabetic foot ulcer infections (DFUs) to target a market which is estimated to be a $0.5 billion global sales opportunity based on the incidence of such infections, the costs of the associated medical care and a realistic product pricing of XF-73 in this new market. Driven by the growing number of diabetics and associated complications such as infected DFUs, this represents a significant market opportunity for XF-73. As with all anti-infectives, AMR is also a concern within this market. There is no dominant treatment for DFUs and specialist physicians are therefore working to find better treatment options, including topical formulations. In addition, the target product profile of XF-73 tested favourably with dermal clinicians looking for better treatments for the smaller market for burns/wound infections and venous leg ulcers.

Destiny’s China partner CMS is also running a programme for XF-73 in superficial skin infections.

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.

24 January 2022 – Clinical and commercial opportunity of NTCD-M3

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

Significant clinical and commercial opportunity of NTCD-M3 confirmed by positive data from US research study and new market research

  • US Department of Veterans Affairs study confirms the potential of NTCD-M3 as a novel treatment to prevent the recurrence of CDI that can be used alongside all standard-of-care antibiotic treatments
  • US and European market research underpins clinical support and market opportunity

Brighton, United Kingdom, 24 January 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, today announces the successful outcome of the Cooperative R&D agreement with the US Department of Veterans Affairs with NTCD-M3, a novel microbiome therapeutic being developed to reduce the recurrence of Clostridioides difficile infections (CDI) in the gut. The research results confirmed NTCD-M3’s ability to colonise the gut after antibiotic administration, which strengthens the market opportunity as it supports its use following commonly used antibiotic treatments. The Company also announces findings from North American and European market research which reinforce the clinical support and market potential of NTCD-M3.

Oral antibiotics kill beneficial bacteria in the gut, causing unintentional and harmful collateral damage. This allows Clostridioides difficile to grow in the gut and release toxins which cause disease. CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year. It is estimated that CDIs result in an additional US$6 billion in healthcare costs per year in the US alone. Destiny Pharma’s late‑stage asset NTCD-M3, which has already completed successful Phase 2 clinical trials, has been shown to prevent recurrence following the normal standard-of-care antibiotic treatment with only a 5% recurrence rate – the Company believes this is the biggest reported reduction in CDI recurrence from clinical studies.

Some antibiotics used for the treatment of CDI, including fidaxomicin (Dificid®), can remain in the gut for a prolonged period after treatment, potentially impacting the ability of NTCD-M3 to colonise and prevent infection recurrence. The US Department of Veterans Affairs conducted a preclinical study using the best accepted CDI research model. The study demonstrated successful (100%) gut colonisation of NTCD-M3 following treatment with fidaxomicin (Dificid®). In addition, successful (100%) NTCD-M3 gut colonisation was also demonstrated following pre-treatment with vancomycin, the most commonly used first-line antibiotic treatment for CDI. These results provide further support and rationale for the use of NTCD-M3 as an adjunct to both current standard-of-care treatments, vancomycin and fidaxomicin, for the prevention of CDI recurrence.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased with the outcome of our collaboration with the expert CDI team at the Edward Hines, Jr. VA Hospital. We are encouraged by these latest findings that support the administration of NTCD-M3 to the broadest CDI patient population receiving any approved antibiotic treatment and strengthens our planning for the NTCD-M3 Phase 3 study, which we aim to start later this year. The market research further supports these findings and will be invaluable in helping to position NTCD-M3 for the prevention of CDI, as well as development and commercial considerations critical to determining the product’s market potential. There is significant value potential in our NTCD-M3 asset, and we look forward to providing further updates on the regulatory and development plans throughout 2022.”

Destiny Pharma collaborated on this research project with the Edward Hines, Jr. VA Hospital in Hines, Illinois, which has long been recognized for its advanced research into the diagnosis, epidemiology, prevention, and treatment of CDI.

Stuart Johnson, M.D. Professor of Medicine, Loyola Stritch School of Medicine who leads the team at the Edward Hines, Jr. VA Hospital, said: “These results provide support and rationale for the use of NTCD-M3 as an adjunct to both current standard of care treatments, vancomycin and fidaxomicin, for the prevention of recurrence of CDI.”

North American and European market research has also been completed to understand the commercial implications of the clinical and market access landscape in CDI for NTCD-M3. Interviews were conducted with High-Volume Prescribers (HVPs) and reimbursement experts across the US and Europe. The findings provide powerful external validation for Destiny Pharma’s product NTCD-M3 from clinicians and payers in both the US and Europe.

Key findings from the market research include:

  1. Physicians were very optimistic about NTCD-M3’s potential given the very low recurrence rate of 5% seen in the Phase 2 study, its mechanism of action, and safety profile. NTCD-M3 has low cost of goods, long shelf life, and if it can replicate the 5% recurrence rate in a Phase 3 study, would be much more efficacious in preventing recurrence when compared to products in development and on the market. A simple administration profile of one capsule per day for 7 days to achieve colonisation was also seen as beneficial over the competitors.
  1. There is significant interest in using the product to prevent recurrence after a primary episode (a first infection) and first recurrence (those who have had a first infection and then subsequently a recurrence) patients. These are patient groups with significant medical need and where it is necessary to disrupt the recurrence escalator early on before patients get into a terrible cycle of cure and recurrence which leads to increased morbidity and increased mortality.
  1. Taking all the benefits together including cost and ease of use, the clinicians could see significant benefit of NTCD-M3’s approach over FMT (Faecal Microbiota Transplant) or bacterial consortia products. Payers in both the US and EU anticipate strong reimbursement potential given NTCD-M3’s profile and at a price to encourage uptake in the primary episode and first recurrence patients. They could see the benefit of using the product early to reduce the cycle of recurrence and in turn reduce the significant healthcare burden managing this infection places on hospitals and healthcare systems.

ENDS

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark, Manel Mateus, Vici Rabbetts
DestinyPharma@optimumcomms.com
+44 (0) 208 078 4357
www.optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0) 207 220 0500

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

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0

Notes to Editors

About NTCD-M3
NTCD-M3 is a novel microbiome therapeutic being developed to reduce the recurrence of C. difficile infections in the gut. CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year.

NTCD-M3 has the potential to become the leading treatment for CDI prevention, as its Phase 2 data demonstrated a class leading 5% rate of recurrence compared to 30% with placebo.

The benefits of NTCD-M3 include:

  • Single bacterial strain: a naturally occurring, single strain of a non-toxigenic bacteria
  • Excellent safety profile: well-defined treatment
  • Strong clinical data: NTCD-M3 recurrence rate of 5% versus 30% with placebo, which is “class leading”
  • Convenient treatment option: complementary to all current standard of care antibiotic treatments, administered as a single capsule once daily for seven days
  • Well-established manufacturing: will be manufactured at high volume and low cost with a long shelf life which should enable high uptake and a strong pharmacoeconomic position

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

For further information, please visit  www.destinypharma.com

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

21 January 2022 – Destiny Pharma Lancet Report

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

Important Lancet report highlights growing threat of Antimicrobial Resistance with over one million deaths per year

Destiny Pharma’s XF platform is delivering effective drug candidates that also address the threat of AMR

Brighton, United Kingdom, 21 January 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, today notes the publication of a major Lancet study highlighting that over one million deaths occurred in 2019 due to bacterial Antimicrobial Resistance (AMR) and that AMR is one of the leading causes of death across the world. The report also notes the importance of infection prevention in mitigating AMR and names Staphylococcus aureus as one of the six leading lethal pathogens.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “This report validates the very real clinical need and potential global commercial opportunity for our XF platform as it  delivers clinical candidates that prevent infections whilst addressing the threat of AMR. The excellent results from our Phase 2b study demonstrate the potential of our XF-73 nasal gel to prevent post-surgical infections caused by S. aureus, such as MRSA, and we are focused on finalising the Phase 3 clinical trial plans. Additionally, we are testing XF-73 in two dermal infection preclinical programmes.”

Link to Lancet review: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext

Destiny Pharma’s XF platform delivers new infection prevention treatments that have been shown in published studies not to generate AMR due to XF’s novel, fast, mode of action. XF drugs therefore have the potential to help address this global health threat. Destiny Pharma is committed to progressing the most advanced XF clinical candidates through clinical trials in order to meet the established clinical need and the significant commercial opportunities.

In 2021, The Company announced strong positive results from its Phase 2b clinical study of XF-73 nasal gel, as a new product for the prevention of post-surgical infections such as methicillin-resistant Staphylococcus aureus (MRSA). The primary efficacy endpoint was met with an exceptionally high statistical significance and no treatment related safety events.

Destiny Pharma is in advanced discussions with regulatory authorities in Europe and the US to clarify the design, size and costs of the final Phase 3 clinical trials needed for registration. The Company expects to receive feedback from the European Medicines Authority (EMA) during Q1 this year and from the Food and Drug Administration (FDA) in Q2, 2022. Furthermore, the Company is confident this Phase 3 clinical trial clarity will help with the negotiation of partnering agreements.

ENDS

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark, Manel Mateus, Vici Rabbetts
DestinyPharma@optimumcomms.com
+44 (0) 208 078 4357

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0) 207 220 0500

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

MC Associates AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0

Notes to Editors

About Destiny Pharma

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

For further information, please visit  www.destinypharma.com

Forward looking statements

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

04 November 2021 – SAB Member Prof. Gerding is Keynote at C.diff Conference

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

Destiny Pharma’s SAB Member Professor Dale Gerding is Keynote Speaker at C. diff. International Conference

Brighton, United Kingdom – 4th November 2021 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, today announces that its Scientific Advisory Board Member, Professor Dale Gerding, MD, MACP, FIDSA, FSHEA, will be giving a keynote presentation at the C. diff International Conference & Health EXPO to be held in-person and virtually from 4th – 5th November 2021. Destiny Pharma is a Gold Sponsor of the event.

Prof. Gerding’s presentation titled ‘Adjunctive Therapy for CDI to Prevent Recurrence: What Works and Practical Issues’ will be at 7.20pm – 7.40pm GMT/ 2.20pm – 2.40pm EST on Friday 5th November 2021. Registration for the Conference can be found here.

Destiny Pharma’s late-stage asset, NTCD-M3, is a novel microbiome therapeutic being developed to reduce the recurrence of C. difficile infections (CDI) in the gut. CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are delighted to be sponsoring this important global event which raises C.difficile awareness and brings together patients and drug developers. We are also very proud to have our Scientific Advisory Member, Professor Dale Gerding invited as a Keynote Speaker. Prof. Gerding is a world-leading expert in C. difficile infections and the discoverer of NTCD-M3, Destiny Pharma’s Phase 3 ready microbiome therapeutic. NTCD-M3 has the potential to become the leading treatment for CDI, as its strong Phase 2 clinical data and target product profile shows clear advantages to both existing CDI treatment options and those currently in clinical development.”

-END-

For further information, please contact:

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

Optimum Strategic Communication
Hollie Vile / Manel Mateus / Vici Rabbetts
+44 (0) 208 078 4357
destinypharma@optimumcomms.com

finnCap Ltd (Nominated Adviser and 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)20 3705 9321

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0

About Destiny Pharma

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

For further information, 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.

27 September 2021 – Expansion of clinical pipeline

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

Expansion of clinical pipeline

New XF-73 skin infection clinical programme planned to start in China led by existing partner, China Medical System Holdings Limited

Targeting prevention and treatment of superficial skin infections caused by bacteria

Brighton, United Kingdom – 27 September 2021 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, is pleased to announce that the Company’s China regional partner and investor, China Medical System Holdings Limited (CMS), is establishing a new programme with XF-73 targeting the prevention and treatment of superficial skin infections caused by bacteria.

The programme will be run in China and will be focused on delivering a novel product in the local regulatory environment. The project will be led, managed and funded by CMS. Destiny Pharma will contribute scientific advice as required through a steering committee to the expert dermatology team at CMS. CMS has an extensive portfolio of dermatology assets and an expert understanding of the market and its requirements through its existing sales and marketing infrastructure.

Destiny Pharma has cross-reference rights to data generated from the programme and, in the future, could start a similar skin infection clinical programme focused on commercial territories outside those held by CMS (China and other Asian countries excluding Japan).

Destiny Pharma is currently running its own dermal programme with XF-73 in a different indication targeting the prevention and treatment of serious infections associated with burns and open wounds.  This programme is in collaboration with both the US government’s National Institute of Allergy and Infectious Diseases (NIAID), and as part of the Global AMR Innovation Fund (GAMRIF) funded UK-China bilateral partnership to tackle AMR which is managed by Innovate UK. This new CMS initiative adds a further, differentiated product to Destiny Pharma’s pipeline, leveraging off the very strong efficacy, formulation and safety package generated to date by the XF platform.

Neil Clark, Chief Executive Officer of Destiny Pharma said: “We are very pleased to announce the addition of this new XF-73 dermal clinical programme to our portfolio with our partner China Medical System Holdings Limited. We are looking forward to the future development of this programme as well as our other infection prevention assets as we continue to build a high quality, late-stage biotechnology company.”

-END-

For further information, please contact:

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

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

finnCap Ltd (Nominated Adviser and 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)20 3705 9321

MC Associates AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0

About Destiny Pharma

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

For further information, 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.

26 August 2021 – Notice of Interim Results and Investor Presentation

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

Notice of Interim Results and Investor Presentation

Brighton, United Kingdom – 23rd August 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, will announce its Interim Results for the period ended 30th June 2021, on Thursday 9th September 2021.

Neil Clark, Chief Executive Officer and Shaun Claydon, Chief Financial Officer, will provide a live presentation on the same day, at 09:30 am BST, followed by a Q&A session accessible via the Investor Meet Company platform. The webcast of the presentation will be available on the Company’s investor relations website at www.destinypharma.com.

The presentation is open to analysts and all existing and potential new shareholders. Questions can be submitted pre-event via the Investor Meet Company Dashboard up until 09:00 am BST the day before the meeting, or at any time during the live presentation.

Investors can sign up to Investor Meet Company for free, and add to meet Destiny Pharma plc via:

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

Investors who already follow Destiny Pharma plc on the Investor Meet Company platform will automatically be invited.

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For further information, please contact:

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

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

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0) 207 220 0500

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

About Destiny Pharma

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

For further information, please visit  www.destinypharma.com

02 August 2021 – Secondary endpoint analysis from Phase 2b trial

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

Update on secondary endpoint analysis from recent positive Phase 2b trial

Cardiac surgery patients receiving XF-73 nasal gel exhibited a valuable,
sustained nasal reduction of Staphylococcus aureus

Brighton, United Kingdom, 2nd August 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections is pleased to announce additional, strong data from its recent Phase 2b clinical trial.  In March 2021, the Company announced that this study had met its primary endpoint, demonstrating a highly significant reduction of 2.5 log (>99%) in nasal Staphylococcus aureus immediately prior to surgery compared to placebo (p<0.0001) after just 24 hours of XF-73 nasal gel dosing. The placebo-treated patients showed only a 0.4 log reduction in bacterial load immediately before surgery. All patients in the study also received antibiotic dosing as standard of care.

Today’s additional data shows that XF-73 dosed patients can also benefit from a sustained bacterial reduction at the three post-surgical sample time points after wound closure of 1 hour, 2 and 6 days demonstrating 2.5 log, 2.4 log and 2.8 log reductions, respectively, and sustaining the drop of over 99% in S. aureus nasal burden.  The placebo treated patients reported 0.4 log, 1.5 log and 2.5 log reductions at the same time points. The bacterial reductions in XF-73 treated patients were shown to be highly statistically significant over placebo at the 1 hour and 2 days post-surgery timepoints (p<0.0001 and p<0.003, respectively). As a result of the antibiotic dosing used as standard of care, the 6-day time point reduction in the placebo group were equivalent to the XF-73 arm which was expected as it is known (*Wilson et al, 1977) that pre- and post-surgical systemic anti-staphylococcal antibiotic dosing elicits a slow, gradual reduction in nasal bacterial carriage.

This sustained nasal microbiological effect in the period of greatest risk (pre-surgery to wound healing) of XF-73 in patients is a desirable attribute for the reduction in the risk of acquiring a post-surgical, staphylococcal infection. Today’s new data demonstrates that XF-73 nasal gel has the potential to keep patients at a significantly low S. aureus nasal burden during the period of highest infection risk which runs from 1 hour prior to incision, during surgery itself, to the start of wound healing and out to at least 6 days post-surgery.

Neil Clark, CEO of Destiny Pharma, said:We are very pleased to announce this additional, positive data from the successful Phase 2b study of XF-73 as a novel drug to reduce the incidence of post-surgical infections such as MRSA. We are having discussions with regulators in US and Europe to enable us to design the required Phase 3 clinical study and will announce further updates later in 2021. XF-73 has great potential to provide a safe, fast acting medicine that kills S. aureus in the nose prior to surgery thereby reducing patient infections whilst not generating bacterial resistance. There is a clear clinical need for such a new medicine that helps prevent post-surgical infections and there is a significant commercial opportunity.”

Scientific Advisory Board member, Professor Richard Proctor (Professor Emeritus of Departments of Medical Microbiology & Medicine at University of Wisconsin School of Medicine, Wisconsin, US), said:This new clinical data from the Phase 2b trial wherein XF-73 produces a sustained reduction in nasal burden of S. aureus out to at least 6 days is an important observation for several reasons.  First, nasal S. aureus burden directly correlates with the incidence of post-surgical wound infections.  Second, reduction in S. aureus nasal colonization is associated with decreased numbers of all staphylococcal infections.”

*Wilson et al., In vivo effects of josamycin, erythromycin, and placebo therapy on nasal carriage of Staphylococcus aureus. Antimicrobial Agents and Chemotherapy,1977, 3: p. 407-10)

For further information, please contact:

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

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

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0) 207 220 0500

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

About Destiny Pharma

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

For further information, please visit  www.destinypharma.com

09 July 2021 – XF-73 Phase 2b data to be presented at ECCMID

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

Successful XF-73 nasal gel Phase 2b study data to be presented at 2021 ECCMID Congress

  • Infection prevention expert, Professor Julie Mangino MD to present XF-73 data abstract

Brighton, United Kingdom – 9th July 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines to prevent life-threatening infections, today announces that an abstract providing analysis and discussion of the late-breaking data arising from the recently completed Phase 2b clinical study of XF-73 nasal gel will be presented at Europe’s premier antimicrobials congress, the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) on Saturday, 10 July at 7:35 pm CET

Presentation Title: Repeated doses of exeporfinium chloride (XF-73) nasal gel over 24 hours significantly reduced the burden of Staphylococcus aureus nasal carriage in at-risk surgical patients: preliminary results from a Phase 2 study.

Presenting Author: Julie Mangino MD, FSHEA, FIDSA, Professor Emeritus, Department of Internal Medicine, Division of Infectious Diseases, The Ohio State University College of Medicine, US

Abstract #: 04905

Session: LB: Late breaking clinical trial data

Session code: S182

If you would like to meet with Destiny Pharma, please email us on conferences@destinypharma.com

For further information, please contact: 

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

Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Manel Mateus
+44 (0) 203 174 1789
destinypharma@optimumcomms.com

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 plc

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

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

About ECCMID

ECCMID (https://www.eccmid.org/) is Europe’s premier Clinical Microbiology & Infectious Diseases event, bringing together experts from many fields to present their latest findings, and developments and share their expertise. The scientific programme is built by the ECCMID Programme Committee, and independent group of experts representing all disciplines related to clinical microbiology and infectious diseases.

About XF-73

XF-73 is the lead drug candidate from Destiny Pharma’s XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. XF-73 has been awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the US FDA.

06 July 2021 – NTCD-M3 RD Agreement with US Dept Veterans Affairs

Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

Destiny Pharma and US Department of Veterans Affairs enter into Cooperative Research and Development Agreement to further research NTCD-M3 for prevention of recurrence of Clostridioides difficile infections

Brighton, United Kingdom, 6 July 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, is pleased to announce a Cooperative R&D agreement with the US Department of Veterans Affairs to support studies focusing on identifying new attributes for NTCD-M3, a novel microbiome therapeutic being developed to reduce the recurrence of Clostridioides difficile infections (CDI) in the gut.

Destiny Pharma will collaborate on this research project with the Edward Hines Jr. VA Hospital in Hines, Illinois, utilising their CDI research expertise to complete new preclinical studies that could support the administration of NTCD-M3 to a broader CDI patient population and therefore strengthen the market opportunity. The research project is planned to complete in Q4 2021. Financial terms are not disclosed.

Stuart Johnson, MD Professor of Medicine, Loyola Stritch School of Medicine, will lead the team conducting further studies of NTCD-M3 at the Edward Hines, Jr. VA Hospital, which has long been recognised for its advanced research into the diagnosis, epidemiology, prevention and treatment of CDI.

According to Prof. Johnson, “The potential for prevention of CDI with this non-toxigenic strain of C. difficile has been well-established. However, the mechanism of this protective effect has not been fully established. We are poised to conduct experiments that will help delineate the factors whereby NTCD-M3 prevents infection with toxigenic strains of this ubiquitous pathogen.”

CDI is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the US, there are approximately 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year.

NTCD-M3 has the potential to become the leading treatment for CDI prevention, as its Phase 2 data demonstrated a class leading 5% rate of recurrence compared to 30% with placebo.

The benefits of NTCD-M3 include:

  • Single bacterial strain: a naturally occurring, single strain of a non-toxigenic bacteria;
  • Excellent safety profile: well-defined treatment;
  • Strong clinical data: NTCD-M3 recurrence rate of 5% versus 30% with placebo, which is “class leading”;
  • Convenient treatment option: it is complementary to all current standard of care antibiotic treatments, administered as a single capsule once daily for seven days;
  • Well-established manufacturing: will be manufactured at high volume and low cost with a long shelf life which should enable high uptake and a strong pharmacoeconomic position.

Destiny Pharma is progressing the plans for the single Phase 3 clinical study, the design of which has already been discussed with the US FDA, and which needs to be completed before submitting marketing authorisation applications in the US and Europe. The Phase 3 clinical study remains on schedule to commence in 2022.

Destiny Pharma has also commenced discussions with potential licensing partners and collaborators and is encouraged by the level of interest in the programme. The aim is to secure a partner to support the planned Phase 3 clinical study and participate in the future commercial launch of NTCD-M3.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased to be working with the expert CDI team at the Edward Hines, Jr. VA Hospital in Chicago. The planned study will help Destiny Pharma refine our planning for the NTCD-M3 Phase 3 study that we aim to start in 2022. There is a significant clinical and commercial opportunity for NTCD-M3 as a novel treatment to prevent the recurrence of CDI.”

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0) 127 370 4440

Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Manel Mateus
DestinyPharma@optimumcomms.com
+44 (0) 203 174 1789

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0) 207 220 0500

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

About Destiny Pharma

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

For further information, please visit www.destinypharma.com