03 June 2021 – Result of Annual General Meeting

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

Result of Annual General Meeting 

Brighton, United Kingdom – 3rd June 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, announces that all resolutions proposed to shareholders at the Annual General Meeting held earlier today were duly passed.

The full text of each resolution was included in the notice of the meeting, which was made available on the Company’s website and posted to shareholders on 4th May 2021. The results for the resolutions will shortly be available on the Investors section of the Company’s website, www.destinypharma.com.

Nick Rodgers, Chairman of Destiny Pharma, commented:

“It has been a transformational last six months for Destiny Pharma. We recently delivered excellent Phase 2b data from our XF-73 nasal gel clinical study for the prevention of post-surgical infections and have now started talking to regulators regarding possible Phase 3 clinical plans. Also, we expanded our pipeline through the acquisition of NTCD-M3 to take it through its Phase 3 clinical study. NTCD-M3 has the potential to become the leading treatment for C. difficile infections, targeting a market that is forecast to grow to $1.7 billion by 2026. We remain committed to developing our novel products that prevent infections and look forward to delivering further progress and another successful year.”

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 

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

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

About Destiny Pharma

Destiny Pharma is 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 on the company, please visit  https://www.destinypharma.com      

02 June 2021 – Positive update on microbiome therapeutic NTCD-M3

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

Positive update on microbiome therapeutic NTCD-M3 for recurrent C. difficile infections

· Preparations for Phase 3 study progressing to plan
· Established world leading clinical advisory board
· Partnering discussions ongoing

Brighton, United Kingdom – 2nd June 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 positive progress with its lead clinical programme, NTCD-M3.

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.

NTCD-M3 has the potential to become the leading treatment for CDI, as it appears to deliver clear advantages to both existing CDI treatment options and also to those currently in clinical development.

The benefits of NTCD-M3 include:

· Single bacterial strain: a naturally occurring, single strain of a non-toxigenic bacteria
· Good safety: well-defined treatment
· Strong clinical data: CDI recurrence rate for NTCD-M3 treated patients with the best dose in previous Phase 2 trial of only 5% is “class leading”
· Convenient treatment option: can be taken alongside all current standard of care antibiotic treatments as a single capsule taken 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
· Fast Track designation by the FDA

Destiny Pharma is progressing the planning for the single Phase 3 clinical study that 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.

Key development and manufacturing activities undertaken to date include:

· Completed the technology transfer of information into the new contract drug manufacturing organisation (CDMO) that will produce NTCD-M3 in its specialised biotherapeutic fermentation plant
· Completed the set-up of key analytical viability methods that will be used to assess the quality and purity of the spores of NTCD-M3 produced in the manufacturing process
· Initiated process development work on fermentation to achieve a high and reproducible NTCD-M3 concentration
· Preliminary work underway to define a matrix and method of drying to isolate NTCD-M3 within a solid matrix for formulation as an easy to use, stable, oral capsule

Clinical trial planning is progressing well and activities already underway include:

· Establishment of a NTCD-M3 clinical advisory board consisting of Professor Dale Gerding MD US, who discovered NTCD-M3, Professor Mark Wilcox MD, UK key opinion leader in CDI and other medical and drug development experts with recent experience of running and designing international Phase 3 clinical studies in CDI
· Initiated the supplier selection of a clinical trial organisation (CRO) for the Phase 3 study

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 help fund the planned Phase 3 clinical study and participate in the future commercial launch of NTCD-M3.

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

“We have made significant progress since closing the £10.4 million equity funding in December 2020 that enabled the NTCD-M3 acquisition. NTCD-M3 is a potential breakthrough in CDI treatment targeting a market that is forecast to grow to $1.7 billion by 2026 and is a very valuable, late-stage asset. We look forward to making further progress this year and to finalising the Phase 3 study design and manufacturing set up.”

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark/ Shabnam Bashir/ 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) 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 on the company, please visit www.destinypharma.com

25 May 2021 – Further information re AGM

Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

Further information re AGM

Brighton, United Kingdom – 25 May 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, as announced on 19 May 2021, will operate a virtual facility to allow Shareholders to listen in to the business of its Annual General Meeting (“AGM”) to be held at 11.00am BST on 3 June 2021.

The Company is using the Investor Meet Company platform. This platform will allow Shareholders to follow proceedings of the AGM and hear from the Company via the live presentation and Q&A session immediately following the AGM. The Company will also
provide an online recording, available on the Investor Meet Company platform and the Company’s website after the meeting.

Shareholders who wish to attend the online presentation should register for the event in advance via the following link:
https://www.investormeetcompany.com/destiny-pharma-plc/register-investor.

Shareholders are invited to pre-submit questions either to agm2021@destinypharma.com or online via the Investor Meet Company dashboard up until 17.00pm BST on 2 June 2021 or during the meeting itself via the Q&A function. Please include the Shareholder’s name and Shareholder Reference Number (which can be found on the share certificate or proxy form).
Shareholders wishing to vote at the AGM are strongly encouraged to do so by completing a form of proxy, appointing the Chairman of the AGM as their proxy. Shareholders will not be able to vote at the AGM over the online platform.

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark/ Shabnam Bashir/ 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) 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 on the company, please visit https://www.destinypharma.com

19 May 2021 – Notice to Register for 2021 AGM

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

Notice to Register for 2021 AGM

Brighton, United Kingdom – 19 May 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, as announced on 4 May 2021, will hold its 2021 Annual General Meeting (“AGM”) at the offices of finnCap Ltd, Destiny Pharma’s Nominated Advisor and Joint Broker, at 11.00am BST on 3 June 2021. Destiny Pharma will operate an audio dial-in facility to allow Shareholders to listen to the business of the meeting.

As previously announced in the Posting of Annual Report and Notice of AGM, whilst in normal circumstances the Board values the opportunity to engage with shareholders in person at its AGM, on this occasion the Board feels it is appropriate to advise shareholders against travelling to attend the AGM in person and, instead, to submit proxy votes as early as possible because, as matters currently stand, shareholders will not be granted access to the AGM. Shareholders are strongly advised to appoint the Chairman of the AGM as their proxy.

Immediately following the AGM at 11:00am BST, Destiny Pharma will host a live webcast presentation followed by Q&A.

Shareholders will not get an opportunity to vote or ask questions or any other participation during the call but are encouraged to pre-submit any questions for Directors of the Company in advance of the AGM to agm2021@destinypharma.com by no later than 17:00pm BST on 2 June, 2021. Please include the Shareholder’s name and Shareholder Reference Number (which can be found on the share certificate or proxy form) in your email.

A full recording of the 2021 AGM will be made available on the Company’s website at www.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, Shabnam Bashir, 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

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

06 May 2021 – Destiny Pharma Conference Attendance for May 2021

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

Destiny Pharma Conference Attendance for May 2021

Brighton, United Kingdom – 6th May 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 that its management team will be presenting and participating at the following conferences:

Proactive One2One Virtual ForumThursday 6th May 2021 at 7:00pm BST

Neil Clark, CEO will present at this virtual event, hosted by Proactive Investors. 

Destiny Pharma has been invited to present as a ‘Leading Growth Company’ to provide an overview of the Company and its innovative pipeline.

BioEquity EuropeTuesday 18th May 2021

William Love, Founder and CSO will present and participate in “What is the Next Act for Antibiotics?” panel discussion.

The distinguished panel entitled “What is the Next Act for Antibiotics” includes investors and antibiotics leaders, such as Destiny Pharma, who will discuss and identify the requirements for new mechanisms to incentivize the next act of antibiotics investment and development. The Panel, chaired by Steve Usdin, Senior Editor & Head Policy and Regulation, BioCentury, includes:

  • Frank Kalkbrenner, Ph.D., Global Head, Boehringer Ingelheim Venture Fund
  • William Love, Ph.D., Founder & CSO, Destiny Pharma
  • John Rex, Ph.D., Chief Medical Officer & Director, F2G Ltd. and Editor in Chief, AMR Solutions
  • Henry Skinner, Ph.D., CEO, AMR Action Fund
  • Rafaèle Tordjman, Founder & CEO, Jeito Capital

In addition to the panel discussion, Destiny Pharma will also be presenting to potential partners and investors in attendance.

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

Enquiries:

Destiny Pharma plc +44 (0) 12 7370 4440
Neil Clark (Chief Executive Officer)
Shaun Claydon (Chief Financial Officer and Company Secretary)

Optimum Strategic Communications
+44 (0) 20 3174 1789
Mary Clark / Shabnam Bashir / Manel Mateus


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 infections 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 www.destinypharma.com

15 Apr 2021 – Investor Presentation – 22 April 2021 at 1400 BST

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

Investor Presentation

Brighton, United Kingdom – 15 April 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 that Neil Clark and Shaun Claydon will provide a live presentation relating to Full Year Results for year ending 31 December 2020 via the Investor Meet Company platform on 22 April 2021 at 2 pm BST.

The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9 am 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 via:

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

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

Enquiries:

Destiny Pharma plc
+44 (0) 12 7370 4440
Neil Clark (Chief Executive Officer)
Shaun Claydon (Chief Financial Officer and Company Secretary)

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

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

Optimum Strategic Communications
+44 (0) 20 3174 1789
Mary Clark / Shabnam Bashir / Manel Mateus

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 infections 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 www.destinypharma.com

14 Apr 2021 – Audited results for the year ended 31 December 2020 and positive Phase 2b data announced post year-end

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

Audited results for the year ended 31 December 2020

Phase 2b XF-73 clinical trial: patient recruitment completed and
positive Phase 2b data announced post year-end 

£10.4M equity raise to acquire NTCD-M3 completed 

Grant supported COVID-19 collaboration announced

Company funded through to Q4 2022

Brighton, United Kingdom – 14th April 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, announces its audited financial results for the year ended 31 December 2020.

Financial and corporate highlights

  • Successful equity fund raise of £10.4 million (gross) to acquire NTCD-M3 for the prevention of Clostridioides difficile (difficile) infection recurrence
  • Strong year end cash position with cash and term deposits of £9.7 million (2019: £7.5 million)
  • Increase in R&D expenditure to £4.5 million (2019: £3.8 million) due to planned clinical development costs associated with XF-73 nasal gel Phase 2b study
  • Cash runway extended to Q4 2022 as a result of equity fund raise and careful management of operational activities

Operational highlights

Phase 2b clinical trial: XF-73 nasal gel for prevention of post-surgical infections

  • Patient recruitment successfully completed in December
  • Positive top-line results reported in March 2021. Primary efficacy endpoint successfully met with an exceptionally high statistical significance and no treatment related safety events
  • In discussion with US FDA with regards study design for Phase 3 clinical study

NTCD-M3 for prevention of C. difficile infection recurrence

  • Acquisition of global rights to NTCD-M3, a Phase 3 ready asset for prevention of difficile infection recurrence completed during Q4 2020
  • Protocol for Phase 3 clinical study agreed with FDA
  • Commencement of key work required to prepare for a Phase 3 clinical study to be ready to start in 2022
  • Professor Dale Gerding, discoverer of NTCD-M3 and world leading expert in difficile infections appointed to the Company’s Scientific Advisory Board
  • Major new contract signed with leading biotherapeutics manufacturing company for production of Phase 3 clinical trial doses

SporeGen COVID-19 collaboration

  • Destiny Pharma and SporeGen Limited announced collaboration and Innovate UK grant award of £800,000 to co-develop a novel, preventative product for COVID-19
  • Expands Destiny Pharma’s novel pipeline targeted at preventing infections with novel biologics/microbiome approach

Earlier pipeline and research projects

  • Research projects with Cardiff, Sheffield, Southampton and Aston Universities making good progress after COVID-19 delays
  • New grant awarded by National Biofilms Innovation Centre (NBIC) to fund a second research collaboration with Cardiff University in oral infections
  • Oxford University review supports the unique target profile of XF-73 and its potential to address the threat of anti-microbial resistance (AMR)

Post period highlights

  • Brazilian patent granted for XF-73 nasal gel
  • Agreement with the US National Institute of Allergy and Infectious Diseases (NIAID) to evaluate a novel XF-73 formulation in skin wound infections
  • Professor Mark Wilcox, a recognised leader in infection prevention and control and renowned expert in difficile infection, appointed to the Company’s Scientific Advisory Board

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

“Destiny Pharma has delivered a very strong performance in the last 12 months and we look forward to further progress this year. We have delivered excellent Phase 2b data from our XF-73 nasal gel clinical study for the prevention of post-surgical infections and also expanded our pipeline through the acquisition of NTCD-M3 – a Phase 3 ready project targeting C. difficile gut infections. The Company has also progressed its earlier pipeline and been awarded additional grant funding including a £800,000 grant from Innovate UK to fund our COVID-19 collaboration. We closed a £10.4m equity funding in December to enable the NTCD-M3 acquisition and have a cash runway through to Q4 2022. We remain committed to developing novel products that prevent infections and have a clear clinical need and a substantial commercial opportunity”

Webcast and Conference Call

Destiny Pharma will host a webcast presentation followed by a live Q&A conference call for analysts and investors today, Wednesday 14th April 2021 at 09:30 am BST.

The webcast of the presentation will be available here and available on the Company’s website at https://www.destinypharma.com/

For details of the Q&A conference call, please contact DestinyPharma@optimumcomms.com

This announcement has been released by Shaun Claydon, CFO, on behalf of the Company.

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

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

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

About Destiny Pharma

Destiny Pharma is 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 on the company, 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.

The full text of the announcement may be found here.

29 Mar 2021 – Destiny Pharma to Join Equity Development Webinar

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

Destiny Pharma to Join Equity Development Webinar on
Positive Phase 2b Top-line Results for XF-73 Nasal Gel

Primary endpoint achieved with >99% nasal bacterial load reduction (p<0.0001)
No treatment related adverse events

Brighton, United Kingdom – 29th March 2021 – Destiny Pharma (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, announces that the Company’s management team will host a live presentation on Tuesday 30th March at 3:30pm BST with Equity Development.

On Monday 29th March, the Company was pleased to announce positive top-line results from its Phase 2b clinical study testing its XF-73 nasal gel product in patients undergoing surgery at risk of post-surgical infections such as methicillin-resistant Staphylococcus aureus (MRSA). The primary efficacy endpoint was met and there were no treatment related safety events. Click on the link to the press release here.

The presentation will be hosted by Neil Clark, Chief Executive Officer and Shaun Claydon, Chief Financial Officer. The online presentation is open to all existing and potential shareholders. Questions can be submitted during the presentation to be addressed at the end.

To register for the Equity Development webinar please click here: https://zoom.us/webinar/register/WN_eIPSQ5KaRYqdy6OIzZZD-A

A recording of the presentation will be available after the event on both the Equity Development website and on the Destiny Pharma website.

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, 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 

29 Mar 2021 – Destiny Pharma Reports Positive Phase 2b Results for XF-73 Nasal Gel

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

Destiny Pharma Reports Positive Phase 2b Results for XF-73 Nasal Gel

Primary endpoint achieved with >99% nasal bacterial load reduction (p<0.0001)

Excellent safety profile. No treatment related adverse events

Brighton, United Kingdom – 29th March 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, today announces positive top-line results from its Phase 2b clinical study testing its XF-73 nasal gel as a new product for the prevention of the incidence of post-surgical infections such as methicillin-resistant Staphylococcus aureus (MRSA). The primary efficacy endpoint was met with an exceptionally high statistical significance and there were no treatment related safety events.

Clinical Study Results Highlights

  1. Met primary endpoint: XF-73 reduced the mean nasal burden of S. aureus in patients undergoing open heart surgery by 2.5 log (CFU/ml) in the 24 hours immediately before surgery in the micro-ITT (Intend to Treat) population, a statistically highly significant result, (p<0.0001). This equates to a 99.5% reduction in S. aureus bacterial nasal carriage which is a very effective reduction by accepted clinical measures.
  2. XF-73 showed 2.1 log, (>99%), greater reduction than placebo in the same patient population and this difference in reduction of nasal burden of S. aureus was statistically highly significant (p<0.0001) in both the micro-ITT and per protocol populations. The effect was maintained during surgery, considered the period when the risk for infections is the highest.
  3. Initial analysis of secondary endpoints shows a higher reduction of burden of nasal S. aureus in the XF-73 arm compared to placebo arm in the 24 hours before surgery, and this was also observed when the data was analysed by area under the curve (AUC) and percentage of patients reaching a specific log reduction.
  4. These positive results were achieved with just four doses of 0.2% (w/w) XF-73 nasal gel in the 24 hours before incision and the start of surgery.
  5. There were no treatment related adverse events.
  6. Full results will be published in due course in a peer reviewed journal.

There is a global need for better treatments such as XF-73 which has been awarded Qualifying Infectious Disease Product (QIDP) and Fast Track status by the US FDA. Destiny Pharma now plans to discuss possible Phase 3 clinical study designs with regulatory bodies including the US FDA. The Company believes that there is a significant commercial opportunity for XF-73 in the hospital setting which could generate peak annual product sales of up to $1 billion in the US alone.

Richard Proctor, MD, Professor Emeritus of Department of Medical Microbiology/Immunology and Department of Medicine at University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA, and member of the Company’s Scientific Advisory Board, said:The completion of the Phase 2b clinical trial with XF-73 nasal gel is an important milestone in the fight against Staphylococcus aureus infections that occur in surgical patients.  These infections can be reduced by decreasing the numbers of S. aureus in the nose prior to surgery.  XF-73 nasal gel was very well tolerated and highly effective in clearing these organisms. This antibacterial drug has a new mechanism of action which appears to address bacterial resistance enabling widespread use, unlike antibiotics.  This trial is an important step in the fight against this worldwide epidemic of antibiotic resistant S. aureus (including MRSA) as all attempts to date to develop a S. aureus vaccine have failed.”  

Julie E. Mangino MD, FSHEA, FIDSA, Professor Emeritus at The Ohio State University College of Medicine and Chair of this Phase 2b Data Safety and Monitoring Committee, commented: “The rapid onset of XF-73’s nasal S. aureus decolonization shown in this Phase 2 study represents highly encouraging news for patients who are to undergo surgery and are at risk of post-operative staphylococcal infections as well as for hospitals working to prevent them.”

Neil Clark, Chief Executive Officer of Destiny Pharma, said: We are delighted with these excellent results. We have delivered strong confirmation from this Phase 2b study of the potential of XF-73 to prevent post-surgical infections such as MRSA caused by the bacteria Staphylococcus aureus.

“There is a significant global commercial opportunity for XF-73 nasal gel to help prevent hospital infections and this excellent data supports the proposed target product profile for XF-73 as being a safe, fast, effective decolonising nasal gel that is cost efficient and easy to use in standard surgery protocols. Critically, XF-73’s rapid mechanism of action does not generate Antimicrobial Resistance (AMR) as demonstrated in peer reviewed publications and it can therefore help in the fight against superbugs.”

Destiny Pharma’s lead product XF-73 is being developed for the “prevention of post‑surgical staphylococcal infections”. These infections are predominantly caused by the bacterium Staphylococcus aureus (S. aureus). A third of the human population are carriers of S. aureus, typically in the nose, and are at a significantly higher risk of acquiring a post-surgical infection.

In the US there are no approved drugs for the prevention of post-surgical staphylococcal infections. The generic antibiotic mupirocin has been used to treat patients who carry the bacteria prior to surgery to reduce the risk of infection. However, the use of existing preventative treatments is severely limited by the existence, and fear of generating, drug resistant bacteria. In contrast, XF-73 has been shown not to generate drug resistant bacteria, and this superior bacterial resistance profile makes it ideally suited for widespread use for the prevention of post-surgical infections.

XF-73 Phase 2b study outline

“Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S. Aureus in Patients at Risk of Post-op Staphylococcal Infection”

XF-73 is a first-in-class 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 QIDP and Fast Track status by the US FDA.

This was a Phase 2b multi-centre, double blind, randomized, 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 S. aureus nasal carriage in patients scheduled for surgical procedures deemed to be at high risk of post-operative S. aureus infection.

The study was divided in 4 periods: screening (days -14 to -1), randomization (days -10 to -1), treatment (days -1 and 0) and follow-up (post-last study dose to day 30 or day 90 if an implant is inserted during surgery). Day 0 is the calendar day on which surgery takes place. Only patients who tested positive to S. aureus by a centrally performed rapid diagnostic test were enrolled in the study. 124 patients were randomly allocated in a 1:1 ratio to 0.2% w/w XF-73 nasal gel treatment or placebo to match XF-73 nasal gel.

The study drug, 0.2% w/w XF-73, or matched placebo was administered 4 times into each nostril over 24 hours prior to surgery and then a single application immediately upon closure of surgical wound. Additionally, patients could undergo chlorhexidine skin decolonisation ahead of surgery and receive perioperative prophylactic systemic antibiotics in accordance with local practice.

Efficacy was assessed by S. aureus colonisation from screening to 7 days after surgery as well as by incidence of post-operative staphylococcal infections and use of anti-staphylococcal antibiotics post-surgery. Safety was assessed by reported adverse events (AEs) from screening up to Day 7 as well as vital signs, physical examination (ENT), clinical laboratory assessments (haematology, clinical chemistry, and urinalysis) and Smell Identification Tests at different time points throughout the study.

The maximum study duration was up to 45 or 105 days for each individual (from screening to post-study follow-up visit) depending on whether a foreign implant was inserted during surgery.

An independent data and safety monitoring committee (IDMC) reviewed the safety information from the study, the incidence of post-operative staphylococcal infections and to ensure that the balance of benefits and risks of participating in the study did not change. For more information visit https://clinicaltrials.gov/ct2/show/NCT03915470

Webcast and Conference Call

Destiny Pharma will host a webcast and conference call for analysts and investors today, 29 March, at 11:00am BST.

A live webcast of the presentation will be available here. A recording of the presentation will be available following the event on the Company’s website at https://www.destinypharma.com/

Dial-in details are provided below. Please join the event 5-10 minutes prior to scheduled start time and reference conference confirmation code: 2401371.

Location Phone Number
United Kingdom, Local +44 (0)330 336 9434


This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (“MAR”), and is disclosed in accordance with the company’s obligations under Article 17 of MAR.

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

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

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

About Destiny Pharma

Destiny Pharma is 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 on the company, please visit  https://www.destinypharma.com

16 Mar 2021 – Notice of Full Year Results and Clinical Trial Update

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

Notice of Full Year Results and Clinical Trial Update

Brighton, United Kingdom – 16th March 2021 – Destiny Pharma (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, will announce its financial results for the year ended 31 December 2020, on Wednesday 14th April 2021.

Destiny will host an analyst presentation on the same day, at 9:30 am BST, followed by a Q&A session, accessible via conference call or webcast. The webcast of the presentation will be available on the Company’s investor relations website at https://www.destinypharma.com/

For details of the conference call, please contact DestinyPharma@optimumcomms.com

The Company is also pleased to announce it has completed the “data lock” on the Phase 2b clinical study testing its XF-73 nasal gel as a novel product for the prevention of post-surgical infections such as MRSA caused by Staphylococcal aureus and is expecting to announce the study results at the end of this month. Destiny will hold a webcast on the same day of this clinical trial results’ announcement to discuss the findings of the study, details to be confirmed.

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