12 April 2022 – Audited results for year ended 31 December 2021

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

Audited results for the year ended 31 December 2021

Good progress preparing NTCD-M3 Phase 3 programme targeting C. difficile infection recurrence

Discussions continue to progress with potential licensing partners for NTCD-M3

Primary endpoint met in XF-73 nasal Phase 2b clinical study

Secondary endpoint data showed XF-73 nasal exhibited a significant and sustained nasal reduction of S.aureus

Positive feedback from European Medicines Agency on XF-73 nasal Phase 3 programme design

£6.5M post period equity fundraise completed – Company funded through to mid-2023

Brighton, United Kingdom – 12 April 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, announces its audited financial results for the year ended 31 December 2021.

Financial and corporate highlights

  • Loss before tax of £6.3 million (2020: £6.5 million)
  • R&D expendiure of £3.7 million (2020: £4.5 million)
  • Other operating expenses (excluding share based payment charge) of £2.3 million (2020: £1.9 million)
  • Year-end cash and cash equivalents of £4.6 million (2020: £9.7 million)
  • Post period equity fund raise of £6.5 million
  • Cash runway extended to mid-2023

Operational highlights

NTCD-M3 for prevention of C. difficile infection recurrence

  • Good progress made during the year with the transfer and commencement of manufacturing scale up processes and advancement of discussions with US and European regulators on finalising the detail of the Phase 3 clinical trial design. Regulatory discussions are expected to conclude in the first half of 2022, manufacturing scale up by year-end and the Phase 3 trial is targeted to commence thereafter.
  • Discussions are progressing with potential licencing partners, with several parties active in the data room. This is in line with the Company’s strategy of seeking partners to co-fund Phase 3 trials and lead commercialisation of the asset.
  • US Department of Veterans Affairs research study confirms the potential of NTCD-M3 as a novel treatment to prevent the recurrence of C. difficile infections (CDI) that can be used alongside all standard-of-care antibiotic treatments.
  • US and European market research underpins clinical support and market potential of NTCD-M3.
  • 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.

XF-73 nasal gel for prevention of post-surgical infections

  • Positive top-line results in Phase 2b clinical study reported in 2021. Primary efficacy endpoint met successfully with high statistical significance and no treatment related safety events.
  • Very good secondary endpoint data announced in August 2021 showed that XF-73 has the potential to keep patients at a significantly low  aureusnasal 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 6 days post-surgery.
  • Independent European report underpins the clinical need and market opportunity of XF-73 nasal gel which is seen as a very promising alternative to the current standard of care, Mupirocin, by both clinicians and payers.
  • Successful XF-73 nasal gel Phase 2b study data was presented at 2021 ECCMID (European Congress of Clinical Microbiology & Infectious Diseases) Congress by infection prevention expert, Professor Julie Mangino MD.

Earlier pipeline and research projects

  • Two new collaborations signed: NIAID in US supporting XF-73 dermal infection programme and US Department of Veterans Affairs to research NTCD-M3 for prevention of recurrence of CDI.
  • Pre-clinical work on SporCov COVID-19 programme in collaboration with joint partner SporGen Limited (which is largely funded by an £0.8 million Innovate UK grant) completing in H1 2022. Plans for next stage of development are being progressed.
  • XF platform research projects are progressing well after Covid-19 delays and are largely funded by grants and non-dilutive funding.

Post period highlights

  • Positive feedback received from the European Medicines Agency (EMA) on plans for XF-73 nasal gel Phase 3 programme design. Phase 3 can use a similar primary endpoint to the successful Phase 2b clinical study, providing a route through Phase 3 trials to the European approval of XF-73 nasal gel as a ground breaking hospital infection prevention product. Feedback from FDA is expected in Q2 2022.
  • Successful completion of the first of two pre-clinical safety studies of XF-73 Dermal formulation. Work continues with US Government’s NIAID to complete preclinical safety package that will support future clinical development of XF-73 Dermal in serious wound infections.
  • China Medical System Holdings Limited (CMS), the Company’s China regional partner and investor, started an additional dermal programme with XF-73 targeting the prevention and treatment of superficial skin infections caused by bacteria.
  • Successful equity fund raise of £6.5 million (gross) to enable continued progress of NTCD-M3 and XF73 nasal toward Phase 3 clinical studies, finalisation of regulatory plans and strengthening of balance sheet.

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

“With full control of two high quality, late-stage clinical assets targeted at infection prevention, both of which are backed by strong Phase 2 clinical data and clear commercial positioning, Destiny Pharma is very well positioned for the future.  We have made excellent progress in developing our pipeline in 2021 and the Board and employees are excited about delivering on our strategy to build a world leading infection prevention company.”

Webcast

Destiny Pharma will host a webcast presentation followed by a live Q&A session at 10:30 am BST today, 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.

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.

This announcement has been released by Shaun Claydon, Chief Financial Officer (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 / Manel Mateus / Vici Rabbetts
+44 (0) 208 078 4357
DestinyPharma@optimumcomms.com

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

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

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 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.

The full text of the announcement may be found here.

31 March 2022 – Presenting data at the ECCMID 2022 Congress

Destiny Pharma plc

(“Destiny Pharma” or “the Company”)

Data on the antimicrobial activity of XF-73 against bacteria within biofilms to be presented at prestigious 2022 ECCMID Congress

Brighton, United Kingdom – 31 March 2022 – Destiny Pharma plc (AIM:DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, today announces that an abstract providing data on the antimicrobial activity of XF-73 against bacteria within biofilms has been accepted for presentation at Europe’s premier antimicrobials congress, the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), to be held 23– 26 April, 2022.  The data were generated as part of a research collaboration with Aston University.

Presentation Title: Antibacterial efficacy of XF-73 via two mechanisms of action against Gram-positive microorganisms in biofilm mode of growth

Presenting Author: Isabella Romeo-Melody

Abstract #: 04656

Session: Preclinical biofilm studies

Session code: 9c

ECCMID (https://www.eccmid.org/) is the world’s premier Clinical Microbiology & Infectious Diseases event, bringing together experts from many fields to present their latest findings, and developments and share their expertise.

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.

If you would like to meet with Destiny Pharma, please email us at 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 / Manel Mateus /Vici Rabbetts
+44 (0) 208 078 4357
DestinyPharma@optimumcomms.com

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

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 SporCov, 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.

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.

28 March 2022 – Result of General Meeting and Total Voting Rights

THIS ANNOUNCEMENT (INCLUDING THE APPENDIX) AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, THE REPUBLIC OF SOUTH AFRICA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION

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

Result of General Meeting
and
Total Voting Rights

Brighton, United Kingdom ‐ 28 March 2022 ‐ Destiny Pharma plc (AIM:DEST) a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, announces that, at the General Meeting held earlier today, all resolutions proposed were duly passed by shareholders on a poll.

Accordingly, the Company has raised total gross proceeds of approximately £6.45 million from the Fundraising and has allotted a total of 12,909,007 New Shares. Admission of the 12,909,007 New Shares, comprised of the Placing Shares, the Subscription Shares and the Open Offer Shares, is expected to occur on 29 March 2022.

Following Admission on 29 March 2022, the Company’s issued ordinary share capital will comprise 73,307,105 Ordinary Shares, none of which are held in treasury. The above figure of 73,307,0105 may be used by Shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the voting rights of the Company under the FCA’s Disclosure Guidance and Transparency Rules.

A summary of the votes received for the General Meeting will be made available on the Company’s website at www.destinypharma.com.

Unless otherwise defined herein, capitalised terms used in this announcement shall have the same meanings as defined in the announcement of the Fundraising made by the Company on 8 March 2022.

Enquiries:

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) 208 078 4357
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Adviser and Joint Broker)
Geoff Nash / Kate Bannatyne / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, ECM
+44 (0)20 7220 0500

MC Services AG (Joint Broker)
Anne Hennecke / Andreas Burckhardt
+49‐211‐529252‐12

For full press release, please click here

25 March 2022 – Result of Open Offer

THIS ANNOUNCEMENT (INCLUDING THE APPENDIX) AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, THE REPUBLIC OF SOUTH AFRICA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION

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

Result of Open Offer

Brighton, United Kingdom – 25 March 2022 Destiny Pharma plc (AIM:DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, announces that it has conditionally raised total gross proceeds of approximately £0.45 million through the Open Offer which was announced on 8 March 2022, representing approximately 45 per cent. proposed under the Open Offer.

Accordingly, the Company has conditionally raised total gross proceeds of approximately £6.45 million in aggregate by way of the Placing, the Subscription (which was also announced on 8 March 2022) and the Open Offer. 

Applications have been made to the London Stock Exchange for the admission of a total of 12,909,007 New Ordinary Shares to trading on AIM. This comprises (i) 11,860,000 Placing Shares; (ii) 140,000 Subscription Shares and (iii) 909,007 Open Offer Shares. The New Ordinary Shares will rank pari passu with the Existing Ordinary Shares. Admission of the Placing Shares, Subscription Shares and Open Offer Shares is expected to occur on 29 March 2022, subject to Shareholders passing the relevant Resolutions at the General Meeting to be held on 28 March 2022.

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

“We are very pleased with the results of the fundraising and the renewed support from our existing as well as new shareholders which will enable Destiny Pharma to accelerate the development of its two, late-stage pipeline assets: NTCD‐M3 is a potential game-changer for the prevention of C. difficile infection (CDI) recurrence, the leading cause of hospital-acquired infection in the US with a potential peak sales opportunity of $0.5 billion. XF-73 nasal is being developed for the prevention of post-surgical staphylococcal infections, a $1 billion market opportunity in the US alone. The funds will enable us to finalise regulatory plans for the Phase III trials of these two lead key assets, complete the manufacturing scale up for NTCD-M3 and strengthen the balance sheet as we progress partnering discussions, and advance Destiny Pharma’s strategy to build a world-leading anti‐infectives company.”

Unless otherwise defined herein, capitalised terms used in this announcement shall have the same meanings as defined in the announcement of the Fundraising made by the Company on 8 March 2022.

For further information, please contact:

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

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

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

MC Services AG (Joint Broker)
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

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 SporCov, 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

23 March 2022 – Destiny Pharma publish in the European Biopharmaceutical Review Journal “Global Rise in AMR Threatens Infection Armageddon”

Dr Bill Love, Chief Scientific Officer at Destiny Pharma, writes “The rise of antimicrobial resistance (AMR) has necessitated ongoing initiatives to offset the global threat and promote innovation, with financial incentives being key to spurring new antibacterial drug development”.

To read the full article, please click here:-

European Biopharmaceutical Review journal – Global Rise in AMR Threatens Infection Armageddon – Dr Bill Love – 22 March 2022

This article is taken from European Biopharmaceutical Review April 2022, pages 31-33. © Samedan Ltd

22 March 2022 – Exercise of Options and Total Voting Rights

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

Exercise of Options and Total Voting Rights

Brighton, United Kingdom – 22 March 2022 – 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 it has issued and allotted 30,000 new ordinary shares of 1 pence each in the capital of the Company (the “New Ordinary Shares”) following an exercise of share options by a former employee.

Application will be made to the London Stock Exchange for the New Ordinary Shares to be admitted to trading on AIM, with dealings expected to commence on 28 March 2022 (“Admission”).

Following Admission, the Company will have a total of 60,398,098 Ordinary Shares in issue. Shareholders may use this figure of 60,398,098 Ordinary Shares as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the FCA’s Disclosure Guidance and Transparency Rules.

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) 208 078 4357
DestinyPharma@optimumcomms.com

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

MC Services AG
(Joint Broker)
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

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 SporCov, 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