22 December 2022 -Year End Trading Update

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

Destiny Pharma announces year end Trading Update

Good progress across all key projects in 2022

Brighton, United Kingdom – 22 December 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, is pleased to announce an update on the progress made in 2022 against its key objectives, including working to finalise a partnering agreement for NTCD-M3, its most advanced clinical programme targeted at infection prevention.

Highlights of 2022

  • NTCD-M3 partnering negotiations nearing finalisation – expected to complete in early 2023.
  • XF-73 Nasal Phase 3 clinical plans clarified. Active partnering programme already underway.
  • Earlier programmes targeting dermal infections and COVID-19 all continued to make good progress in 2022.

NTCD-M3

In line with its strategy, during 2022 the Company has focused on securing a commercialisation partner for NTCD-M3, its lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence. That process has resulted in Destiny Pharma entering exclusive negotiations with one US pharmaceutical company following agreement of heads of terms. The parties are working constructively to close the transaction and announce a collaboration in early 2023.

Whilst there can be no guarantee that these partnering negotiations will complete, nor as to the final terms of a partnering agreement, the headline terms as currently agreed state that all future clinical development and commercialisation of NTCD-M3 in the US will be funded by the partner. The Board believes these proposed terms, providing for security of final clinical development funding, mean that Destiny’s investment in NTCD-M3 will be significantly more valuable without the requirement to contribute towards the funding of the final clinical programme.

XF-73

During 2022, Destiny Pharma has also defined the US and EU Phase 3 clinical development plan for XF-73 Nasal, a novel nasal gel for the prevention of post-surgical infections. Destiny Pharma is now running an active partnering campaign with some early discussions already underway. The target is to secure a commercialisation partner for the XF-73 Nasal programme in 2023.

For both lead clinical programmes, the Company is seeking to close partnerships with pharmaceutical companies that can lead the commercialisation of NTCD-M3 and XF-73 Nasal in key markets, as well as contribute to the funding and design of the required Phase 3 clinical trials.

Good progress has also been made on the Company’s earlier pre-clinical pipeline programmes and 2022 ends with two active dermal infection projects running in the US and China, and with the completion of the SporCov COVID-19 grant-funded collaboration. Further updates on these projects will be announced in H1 2023.

Neil Clark, Chief Executive Officer of Destiny Pharma, noted: “The Board remains fully focused on delivering a comprehensive partnering deal for NTCD-M3, our lead asset, early in 2023 and we are working with the counterparty to achieve this. We are also very excited to finalise our Phase 3 plans for XF-73 Nasal and intensify partnering discussions now that we have detailed regulatory feedback. Our aim is to end 2023 having secured partners for both of our lead assets to complete their final Phase 3 clinical studies, registration and approval in key markets – especially the United States.”

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 / Nick Bastin / Manel Mateus / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

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

Shore Capital (Joint Broker)
Daniel Bush / James Thomas / Lucy Bowden
+44 (0) 207 408 4090

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

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

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.

About Destiny Pharma

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

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

Forward looking statements

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

7 December 2022 – FDA/CDC highlight need for infection preventions

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

US FDA/CDC workshop highlights the need for new approaches
for the prevention of hospital-acquired infections

  • Particular support for decolonisation of pathogens which is the approach taken by its XF-73 Nasal programme

Brighton, United Kingdom, 07 December 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 reports on the publication of findings from the US Food and Drug Administration (FDA) and US Centers for Disease Control (CDC) public workshop on considerations for the prevention of hospital-acquired infection, which can be found here: https://info.rescueagency.com/en-us/drug-development-consideration-virtual-public-workshop-cdc-fda

This workshop brought together representatives from key US government regulators as well as pharmaceutical companies, infection control physicians and patient advocates to discuss the growing issue of hospital-acquired infections in the US and the clear need for new interventions that could address this issue.

Destiny Pharma attended the discussion and was very pleased that the meeting reinforced the Company’s conviction in infection prevention as a key component in the management of serious hospital-acquired infections. The text below is extracted from the published notes of the meeting and provides clear support for the Company’s approach with XF-73 Nasal and NTCD-M3.

Dr Michael Craig, (Director of Antimicrobial Resistance) at the US CDC stated:

  • “Decolonization is something that is very important to us at CDC and something that we think really holds a lot of potential in terms of saving lives and importantly addressing the challenges of antimicrobial resistance that we face, not only in the United States but around the world, and so from our perspective, and I think the bottom line for us, is focusing on drugs that could potentially prevent transmission of deadly pathogens, especially those that are antimicrobial resistant.”
  • “We need to have prevention modalities that can really stop the spread of infectious diseases and deadly pathogens and so what we would like is additional potential drugs that could be brought to bear so that we could further reduce and maybe even eliminate the risk of that colonization becoming an infection in an individual or that colonization spreading to others and being transmitted in sites like nursing homes or ICUs.”

Dr John Jernigan, (Director of HAI Prevention Research and Evaluation, CDC) stated:

  • “Decolonization, by its strict definition, refers to complete elimination of the colonizing microorganism, but for the purpose of our conversations today, I invite you to think about decolonization in a slightly broader context to include pathogen burden reduction or reduction in microbial load of the colonizing pathogen.”
  • “Reducing colonization may be a potent antibiotic resistance prevention strategy. Furthermore, because of their potential for indirect benefit, efforts to produce and improve and approve novel safe and effective decolonizing agents are likely to prevent substantially more harm from antibiotic resistance than can be prevented if we focus drug development solely on drugs that treat infections.”

Destiny Pharma’s infection prevention programmes

Destiny Pharma has two infection prevention clinical programmes that have delivered excellent Phase 2 data and are now heading towards their final Phase 3 clinical studies.

XF-73

XF-73 Nasal is a novel drug being developed by Destiny Pharma to eradicate S. aureus (SA), including MRSA from the nose before surgery to prevent post-surgical infection.  The use of this simple nasal gel before surgery will reduce the need for antibiotic decolonization and by reducing post-surgical infection it will also decrease the use of post-surgical antibiotics to treat infection. There are some 20 million high-risk surgeries and five million intensive care unit (ICU) patient admissions per year in the US alone, a third of whom carry SA in the nose, who could benefit.

NTCD-M3

NTCD-M3 is a single strain biotherapeutic being developed by Destiny Pharma for the prevention of the recurrence of infections caused by toxic strains of the gut bacteria Clostridioides difficile (C. diff). These infections can cause significant inflammation and damage to the gut leading to an estimated 29,000 deaths annually in the US alone (a number comparable to the yearly deaths caused by prostate cancer).

Dr. Yuri Martina, CMO of Destiny Pharma, responded to the findings: “This workshop marks an important starting point for the FDA, CDC and the pharmaceutical industry to exchange ideas and thoughts which look at substantially increasing the development of new drugs addressing infection prevention. A shift in thinking is evident and it has been expressed by many of the speakers during the workshop. This encouragement from the FDA and CDC for new infection prevention products for the US market provides a supportive backdrop for Destiny Pharma’s approach, with its two late clinical stage products targeting infection prevention (XF-73 and NTCD-M3) whilst addressing the threat of antimicrobial resistance (AMR). Using the words of Dr. Craig – ‘Prevention ultimately saves lives.’”

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, Nick Bastin, Manel Mateus, Eleanor Cooper
DestinyPharma@optimumcomms.com
+44 20 3922 0891

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

Shore Capital (Joint Broker)
Daniel Bush / James Thomas / Lucy Bowden
+44 (0) 207 408 4090

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

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

About Destiny Pharma

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

For further information, 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.

7 December 2022 – XF-73 Nasal Phase 3 development plans finalised

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

Destiny Pharma announces finalisation of its Phase 3 development plans for XF-73 Nasal  

Targeting peak sales potential of $1 billion in the major markets

Brighton, United Kingdom – 07 December 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, is pleased to announce that it has now finalised plans for its Phase 3 studies for its late-stage clinical asset, XF-73 Nasal.

Highlights

  • Discussions held with US and EU Regulators and Clinical Key Opinion Leaders
  • Proposing two Phase 3 studies in two major surgery types to aim to provide a broad surgery label for XF-73 Nasal
  • Phase 3 programme will deliver an approvable data package for both US and EU authorities.
  • XF-73 Nasal targeting peak sales potential of $1 billion in its major target markets
  • Phase 3 patient recruitment could start in 2024 subject to completing an XF-73 Nasal partnering deal in 2023

XF-73 Nasal is the lead drug candidate developed from Destiny Pharma’s XF platform and it is initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which can cause significant complications and increased healthcare costs in the hospital setting.

The aim of the announced Phase 3 clinical programme is to deliver comprehensive clinical trial data demonstrating that nasal decolonisation using XF-73 Nasal, alongside “standard of care”, reduces the incidence of post-surgical infections in patients. This meets the requirements of both the US and EU regulators – the FDA and EMA.

After a detailed review, the Company has decided that the Phase 3 programme should consist of two Phase 3 studies including patients in two well-defined surgery models. One study will be in breast surgery as a model for general surgery and the other will be in expedited orthopedic surgery as a model of orthopedic surgery.

This Phase 3 programme is expected to include up to 2,000 patients and deliver a comprehensive data set supporting a clinical endpoint in Surgical Site Infection (“SSI”) reduction that is clinically and statistically significant. Successful clinical studies will therefore provide Destiny Pharma with a broad surgery label for its XF-73 Nasal gel thereby expanding product sales targets and maximizing the commercial opportunity. Post-surgical infections create a significant healthcare burden on hospitals and healthcare systems costing $10 billion per year in the US.  A single MRSA post-surgical infection costs over $160,000 to treat and adds 15 days onto a hospital stay.

In parallel, Destiny Pharma is considering two additional indications for XF-73 Nasal in oncology patients and in community acquired infections. These extra Phase 3 studies would provide supportive data and life cycle management opportunities for XF-73.

Having clarified the Phase 3 study designs, the Company is now expanding its partnering activities on XF-73 Nasal with the aim of securing a deal in 2023.

Dr Yuri Martina, Chief Medical Officer of Destiny Pharma, said: “Having finalized our Phase 3 strategy for our primary indication of SSI prevention, we are ready for the next steps in executing our well-defined and validated strategy. I am excited to see this compound approaching its final clinical trials and moving toward market approval. If successful, XF-73 Nasal will deliver a much needed, novel treatment to help prevent surgical site infections through nasal decolonisation, which is best practice in hospitals across the world and an important unmet medical need for certain patient populations and surgeries.”

Neil Clark, Chief Executive Officer of Destiny Pharma, added: “There is a significant, billion-dollar, potential global commercial opportunity for XF-73 Nasal gel to help prevent hospital infections and to effectively decolonise patients undergoing a wide range of medical treatments. In line with our strategy for 2022, the clinical team has completed an extensive review, spoken with key regulators and finalized our Phase 3 development plans for XF-73 Nasal. While we gear up for the next steps, we are actively seeking a partner to join us in executing the Phase 3 Development plans and lead the commercialization of this exciting new medicine.”

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 / Nick Bastin / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

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

Shore Capital (Joint Broker)
Daniel Bush / James Thomas / Lucy Bowden
+44 (0) 207 408 4090

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

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

About Destiny Pharma

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

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

Forward looking statements

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

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