06 Jan 2021 – Destiny Pharma appoints Stephanie Bewick as Chief Business Officer

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

Destiny Pharma Appoints Stephanie Bewick as Chief Business Officer

Brighton, United Kingdom – 6th January 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, today announces the appointment of Dr Stephanie Bewick as Chief Business Officer.

Dr Bewick brings 20 years’ experience in business development at public and private biotech companies as well as mid-sized pharma, both in-house and as a consultant.  Most recently, she was Vice President, Business Development at Summit Therapeutics, a NASDAQ-listed infectious disease company, leading the out-licensing and in-licensing activities, pipeline positioning and technology valuation. She holds a BSc (Hons) Neuroscience from the University of Edinburgh and a PhD from the University of Bristol.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “I am very pleased to welcome Stephanie to Destiny Pharma. She brings a wealth of experience and a proven track record in business development and deal making having completed a range of transactions including in the anti-infectives space. Her expertise will be invaluable to Destiny Pharma as we look to maximise the value of our two late-stage clinical assets and in building a world leading anti-infection company.”

Stephanie Bewick, Chief Business Officer of Destiny Pharma, added: “This is a very exciting time to join Destiny Pharma after such a transformational year. Destiny Pharma has a fantastic XF platform and biotherapeutic/microbiome pipeline with unique late-stage clinical assets. I look forward to working with Neil and the team to progress the vibrant pipeline.”

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, Shabnam Bashir, 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 is in a 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

05 Jan 2021 – Phase 2b trial of XF-73 completes recruitment

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

Phase 2b clinical trial of XF-73 completes patient recruitment  

Results expected in Q1 2021

Brighton, United Kingdom – 5th January 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, today announces that its XF-73 Phase 2b clinical trial was fully recruited by 31 December 2020, meeting the target timeline set for the programme.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased to have completed enrollment in our Phase 2b clinical trial testing XF-73 nasal gel as a novel product preventing the incidence of post-surgical infections such as MRSA. We previously reported excellent interim safety data in mid-2020 and are now looking forward to announcing the full results of this study and planning the Phase 3 clinical programme. There is a global need for better treatments to prevent post-surgical infections in hospitals as recognized in the FastTrack status awarded to XF-73 by the US FDA. There is also a significant commercial opportunity for XF-73 in the hospital setting which we estimate could generate peak annual product sales of $1 billion in the US alone.

2020 was a transformational year for Destiny Pharma as we accelerated our strategy to build a world leading anti-infection company with a robust pipeline. We established a biotherapeutic/microbiome pipeline alongside our existing XF platform and are now codeveloping SPOR-COV as a novel, preventive treatment for COVID-19. We also raised £10.4 million to acquire NTCD-M3, a Phase 3 ready biotherapeutic treatment for the prevention of C. difficile infection recurrence. The news today on our XF-73 Phase 2b study is another major milestone for the Company and we continue to look forward to announcing the study results in Q1 2021.”

Details of Phase 2b Trial
XF-73 is a first-in-class drug candidate from Destiny Pharma’s XF platform, initially being developed for the prevention of postsurgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. It has been awarded both qualifying infectious disease product (QIDP) and Fast Track status by the US FDA. The Phase 2b trial is a multi-centre, randomised, blinded, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal Staphylococcus aureus nasal carriage in up to 125 patients scheduled for open heart surgery.

The Phase 2b trial design is closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the efficacy of XF-73 versus placebo in reducing Staphylococcus aureus nasal carriage in healthy volunteers. Previous clinical and scientific data supports XF-73 as having a novel mechanism of action and being a safe, fast and targeted anti-infective agent. In microbiological studies it has also shown to not generate anti-microbial resistance (AMR) and therefore has the potential to have a clear advantage over older antibiotic treatments that can lead to the generation of drug resistant “superbugs”.

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, Shabnam Bashir, 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 is in a 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

22 Dec 2020 – Update on the recently acquired NTCD-M3 programme

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

Update on the recently acquired NTCD-M3 biotherapeutic clinical programme for prevention of recurrence of C. difficile infections

Brighton, United Kingdom – 22 December 2020: Destiny Pharma plc (AIM: DEST) a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, announces it is making good progress with preparations for the clinical development of NTCD-M3, a Phase 3 ready biotherapeutic for the prevention of C. difficile infection (CDI) recurrence.

Following the successful fundraising of £10.4 million in November 2020 and completion of the acquisition of NTCD-M3, Destiny Pharma has commenced the work required to prepare for the Phase 3 clinical study that is scheduled to start in 2022.

Also, Professor Dale Gerding has joined Destiny Pharma’s Scientific Advisory Board (SAB) and is working as a key consultant. His world leading expertise in C. difficile infections and many years of research and clinical work on NTCD-M3, will be invaluable and he is an important addition to our team.

Destiny Pharma has also signed a major new contract with a leading biotherapeutics manufacturing company for the establishment of a new NTCD-M3 process for the production of the Phase 3 clinical trial doses. Establishing the new manufacturer will deliver a more efficient process and a lower cost product and is an important investment in the overall NTCD-M3 project. The Company is also starting business development efforts and will reach out to potential commercial partners and grant funding bodies to raise awareness of the re-activated NTCD-M3 clinical programme.

In the US, there are approximately 500,000 cases of CDI each year; around 25% of these initial cases then recur leading to 29,000 deaths per year. Current CDI treatment options are limited with lower efficacy observed when patients are retreated with the same antibiotic for recurrence of CDI. The extra costs of care in US per CDI patient range from $10,000 to $20,000 and the total annual CDI-attributable cost in the US alone is estimated in 2016 at $6.3 billion.

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said, “We are very pleased to have started activities immediately on our new NTCD-M3 project. Setting up the new manufacturing process is a key step to deliver the doses of NTCD-M3 product required for the single, 800 patient Phase 3 study required by the US FDA. The work will also look at scaling up the process towards commercial supply. We look forward to announcing further progress in 2021.”

Professor Dale Gerding, the discoverer of NTCD-M3, and member of Destiny Pharma’s SAB, added: “I am enthusiastic about the resumption of the final phase of development of NTCD-M3 and welcome the opportunity to work with Destiny Pharma to bring it to patients. As a C. difficile clinician and researcher for nearly 40 years, my mission has been to see this terrible infection prevented. Everything that has been done to date suggests that NTCD-M3 will provide the preventive strategy needed to not only prevent recurrence of C. difficile infection but to also prevent it from ever occurring in the most vulnerable patients.”

Enquiries:

Destiny Pharma plc
Neil Clark (Chief Executive Officer)
Shaun Claydon (Chief Financial Officer and Company Secretary)
+44 (0) 1273 704 440

finnCap Limited – Nominated Adviser and Joint Broker
Geoff Nash / Kate Bannatyne / Charlie Beeson (Corporate Finance)
Alice Lane (ECM)
+44 (0) 20 7220 0500

WG Partners LLP – Joint Broker
Nigel Barnes / Claes Spång / Nigel Birks / Andrew Craig
+44 (0) 20 3705 9330

Optimum Strategic Communications
Mary Clark / Shabnam Bashir / Manel Mateus
+44 (0) 203 174 1789

About NTCD-M3
NTCD-M3 (non-toxigenic C. difficile strain M3) was developed by the US infectious diseases physician, Professor Dale Gerding, who is a world-leading specialist in C. difficile infection, with more than 400 peer-reviewed journal publications, book chapters and review articles in the area. NTCD-M3 has successfully completed Phase 1 and Phase 2b trials. The Phase 1 study demonstrated a strong safety/toxicology profile and the Phase 2b showed that the best dose delivered a 95% prevention of CDI recurrence. The Phase 2b NTCD-M3 data was published in the prestigious Journal of the American Medical Association (Gerding DN et al JAMA
2015;313:1719).

C. difficile NTCD-M3 is a naturally occurring non-toxigenic strain of C. difficile bacteria, which lacks the genes that can express C. difficile toxins. It is an oral formulation of NTCD-M3 spores and patients who have taken NTCD-M3 were found to be protected from recurrence of C. difficile infections. NTCD-M3 acts as a safe “ground cover” preventing toxic strains of C. difficile proliferating in the colon after antibiotic treatment. NTCD-M3 temporarily colonizes the human gut without causing any symptoms allowing the gut microbiome time to recover following antibiotic treatment.

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 is in a Phase 2b clinical trial targeting the prevention of postsurgical 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

21 Dec 2020 – Destiny Pharma joins the Pharmabiotic Research Institute (PRI)

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

Destiny Pharma joins the Pharmabiotic Research Institute (PRI)

Brighton, United Kingdom – 21 December 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, has become a member of the Pharmabiotic Research Institute (PRI).

Destiny Pharma has added two active biotherapeutic programs to its pipeline in 2020; a Phase 3 clinical program targeting C.difficile infection recurrence and a grant funded pre-clinical collaboration with SporeGen Limited for the prevention of COVID-19 and other viral respiratory infections. Destiny Pharma is therefore now very active in  biotherapeutic/microbiome product development.

PRI is focused on the human microbiome and is a neutral, non-profit association that applies a collaborative approach to identify and confirm the specific Scientific and Regulatory requirements of microbiome-based, medicinal products, developed for the European market. The PRI counts more than 80 relevant stakeholders from the microbiome and human health field and is the leading centre for microbiome regulatory science.

The global human microbiome market is expected to reach US$1.9 billion by 2027 driven by factors such as increasing incidence of lifestyle diseases, increasing focus on human microbiome therapies, and growing technological advancements in metagenomics and next-generation sequencing.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased to have joined the Pharmabiotic Research Institute.  We look forward to collaborating with PRI and their members with the combined goal of enhancing the development of a European regulatory framework for microbiome products and usiing this insight to assist us in the development of our two biotherapeutic products targeting C. difficile infection recurrence and COVID-19. As a member of PRI, Destiny Pharma will learn about best practice and contribute to regulatory developments in this fast-growing microbiome sector”.

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, Shabnam Bashir, Manel Mateus
+44 (0) 203 174 1789
destinypharma@optimumcomms.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 is in a Phase 2b clinical trial targeting the prevention of post-surgical Staphylococcal hospital 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

About the Pharmabiotic Research Institute (PRI)
The PRI is Europe’s leading microbiome regulatory science expertise center and was founded in 2010 to support the development of microbiome-based medicines for the EU market, for the ultimate benefit of patients. It applies a unique ‘Share & Learn’ approach to overcome the complex and various regulatory challenges faced by relevant stakeholders. Its overall mission is to facilitate the conversation between European regulators and Microbiome medicinal product developers and their partners, and to become the key network of stakeholders driving the new therapeutic and diagnostic innovation in the field microbiome science. For further information, please visit https://www.pharmabiotic.org

25 Nov 2020 – Destiny Pharma announces total gross proceeds raised via Open Offer

Destiny Pharma announces that it has conditionally raised total gross proceeds of approximately £0.87m through the Open Offer which was announced on 9 November 2020. This is in addition to the £9.5m raised in the Placing to support the acquisition of NTCD-M3.

Please press on link below for press release

Destiny Pharma plc – Result of Open Offer