27 May 2022 – Result of Annual General Meeting and Strategy Update

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

Result of Annual General Meeting and Strategy Update

Brighton, United Kingdom – 27 May 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 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 27 April 2022. The results for the resolutions will shortly be available on the Investors’ section of the Company’s website, www.destinypharma.com.

Nick Rodgers, Chair of Destiny Pharma, stated: “Destiny Pharma is in a very strong position having two late-stage assets that have both delivered excellent Phase 2 data and are derived from two totally different technologies. This diversification and the existing robust data sets greatly reduce the risk inherent in drug development and biotechnology company pipelines.

We are on track to achieve our key strategic targets for our two lead programmes, XF-73 nasal and NTCD-M3. Discussions are ongoing with the US and EU regulatory authorities which will allow us to finalise the Phase 3 plans for XF-73 nasal for the prevention of post-surgical S. aureus infections. Active discussions regarding the out-licensing of our lead asset NTCD-M3 targeting the prevention of recurrent C. difficile gut infections are progressing well.

Our Senior Management Team has recently been strengthened with the appointment of an experienced Chief Medical Officer and we have also expanded the Board’s skills through the appointment of new Non-Executive Directors.

The macroeconomic backdrop is challenging and financial markets have had a tough start to the year, but Destiny Pharma is in a strong position to deliver our strategy and develop our novel products that prevent serious infections. We look forward to reporting further progress in the rest of the year.”

ENDS

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
+49-211-529252-0

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

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

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

26 May 2022 – Destiny Pharma plc Board changes

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

Destiny Pharma appoints three Non-Executive Directors

Brighton, United Kingdom – 26 May 2022 – Destiny Pharma plc (AIM:DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces the appointments of James Stearns, Aled Williams and Nigel Brooksby as Non-Executive Directors with effect from 1 June 2022. James Stearns is replacing Dr Huaizheng Peng. The Company has been looking to add Non-Executive Directors following the retirement of Peter Morgan in March this year and has decided to add Aled and Nigel as two new appointments. The Board has expanded its skills and experience base through these additions and is well positioned to continue to deliver its strategy.

James Stearns is the Chief Investment Officer (Europe and America) of China Medical System Holdings Limited (CMS), focusing on its M&A driven growth strategy and overseeing the Venture Programme.  James brings considerable experience in the financial markets having previously worked for both the sellside (Director, Corporate Broking and Advisory at Panmure Gordon) and buyside (Investment Director at LivingBridge). James holds a Joint Honours degree from the University of Bristol in Economics and Accounting.

Aled Williams is Chief Executive Officer of Enthera Pharmaceuticals Srl and was recently Chief Business Officer of Polyneuron Pharmaceuticals Ag. Aled has over 25 years of leadership experience in the pharmaceutical industry, holding senior positions in large pharmaceutical companies (AstraZeneca, Pfizer, Novartis and Bristol-Myers Squibb) and multiple executive management roles in smaller biotech companies. Aled has spent much of his career with responsibility for the external interface from a company, portfolio and asset perspective across a range of different disease areas, including anti-infectives. A microbiologist by training, prior to joining the pharma & biotech industry Aled spent a number of years working in public health.

Nigel Brooksby has extensive experience in the life science sector and has been involved as Chair/ Director/ Strategic Adviser in several fund raisings, including advising Akari Therapeutics on its 2015 NASDAQ listing. Nigel has also undertaken many projects assisting biotech companies in their partnering arrangements with major pharmaceutical companies and has previously held senior global roles at Sanofi, Wellcome (now GSK) and Pfizer.  Until his retirement in 2010, Nigel was a Member of the Sanofi Executive Committee in Europe and North America, and Chair and Managing Director of the Sanofi Group in the UK and Ireland. He has worked internationally based in Europe, the USA, Latin America, the Middle East and Africa.

Nick Rodgers, Chair of the Board of Directors, Destiny Pharma, said: “We are delighted to announce these high calibre appointments to the Destiny Board. The skillset that these individuals bring to the table will be invaluable as we continue to drive forward our strategy and execute our Phase 3 clinical development plans moving towards our next phase of growth. This is an exciting time for Destiny, excellent progress was achieved in the last year developing the clinical pipeline and the Company is well positioned for the future.”

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 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 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 following information is disclosed pursuant to Schedule Two paragraph (g) of the AIM Rules for Companies.

Nigel Stanley Brooksby, aged 71, has been a director of the following companies during the five years preceding the date of this announcement:

Current Past
International Society of Hypertension Novacta Biosystems Limited*
Steel Bars Limited Chronos Therapeutics Limited
Steel Bars Search Limited Prism Ideas Limited
Clinical Insights Limited
Unicorn Pharma Services Limited
Porton Biopharma Limited
Neurocentrx Pharma Limited
IOSBIO Ltd
Pertinax Pharma Limited

 

*Nigel Brooksby was a director at Novacta Biosystems Limited when the Company was dissolved by Members Voluntary Liquidation in April 2019.
 

Aled Paton Williams, aged 52, has been a director of the following companies during the five years preceding the date of this announcement:

Current Past
Enthera Pharmaceuticals Polyneuron Pharmaceutics AG
  VectivBio Pharmaceuticals
  Therachon Pharmaceuticals

 

James Patrick Stearns, aged 42, has been a director of the following companies during the five years preceding the date of this announcement:

Current Past
Monkey Puzzle
Howe Farming Limited
Oakridge Farms

 

There is no further information to be disclosed pursuant to Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

12 May 2022 – Landmark NTCD-M3 data to be presented at Anaerobe

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

World leading C. difficile scientists to present landmark data on the ability of NTCD-M3 to colonise the gut after antibiotic administration

Brighton, United Kingdom – 12 May 2022 – Destiny Pharma (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces that data generated from a recent C. difficile infection (CDI) model study, on the ability of non-toxigenic C. difficile strain M3 (NTCD-M3) to successfully colonise the gut following administration of antibiotics, has been accepted for presentation at the prestigious Anaerobe 2022 Conference in Seattle, WA, US on Saturday, 30th July 2022.

As previously reported, a Phase 2 clinical trial in patients suffering CDI demonstrated that administration of NTCD-M3 shortly after the use of antibiotics to treat the initial infection successfully reduced recurrence from 30% in placebo to 5% in treated patients. Patients received either vancomycin or metronidazole to treat the initial toxic C. difficile infection before receiving NTCD-M3 treatment1. Since the end of this trial, a new antibiotic, fidaxomicin, has been added to US clinical guidelines for treating CDI2. It is known that fidaxomicin3 resides for a longer period within the gut potentially inhibiting the colonisation by bacteria such as NTCD-M3. This latest study by the Microbiology Research Laboratory at the Edward Hines, Jr. VA Hospital in the US sought to address this question by monitoring the colonisation of NTCD-M3 in an established CDI model following administration of fidaxomicin.

In summary, this study conducted in the lab of the authors at the Edward Hines, Jr. VA Hospital, clearly demonstrated that NTCD-M3 was able to effectively colonise the gut following fidaxomicin administration indicating that NTCD-M3 would be effective in patients receiving this antibiotic as well as older antibiotics such as vancomycin and metronidazole.

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: “The relevance and impact of this study cannot be underestimated as it indicates that the clinical use of fidaxomicin to treat CDI is unlikely to affect the ability of Destiny’s late-stage asset, NTCD-M3, to colonise the gut and prevent recurrence of CDI. This is important as fidaxomicin has recently been added to the recommended guidelines for treatment of CDI in the US, and the use of this new antibiotic is growing. We therefore remain confident that our groundbreaking NTCD-M3 live biotherapeutics product can be used alongside all currently recommended antibiotics in the treatment of this serious hospital infection.”

1 Gerding et al. Administration of Spores of Nontoxigenic Clostridium difficile Strain M3 for Prevention of Recurrent C difficile Infection A Randomized Clinical Trial. JAMA May 5, 2015 Volume 313, Number 17

2 Johnson, et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. 73(5), pp.e1029–e1044.

3 Shue YK et al Safety, Tolerance, and Pharmacokinetic Studies of OPT-80 in Healthy Volunteers following Single and Multiple Oral doses Antimicrob Agents Chemother 2008;52:1391-5. Stool drug levels well above MIC of C difficile at 5 days post single dose of 200 or 300 mg.

END

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark / 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 Associates AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0

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

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

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

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

The benefits of NTCD-M3 include:

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

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.

03 May 2022 – Destiny Pharma appoints Dr Yuri Martina as Chief Medical Officer

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

Destiny Pharma strengthens Executive Management Team with the appointment of Dr Yuri Martina as Chief Medical Officer

Brighton, United Kingdom – 3rd May 2022 – Destiny Pharma plc (AIM:DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces the appointment of Dr. Yuri Martina as Chief Medical Officer (CMO).

Yuri brings to Destiny Pharma more than 20 years’ experience and an extensive record of excellence in clinical development and successful interactions at the highest levels with key regulatory, industry and government stakeholders including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceutical and Medical Device Agency (PMDA).

Most recently, Yuri was Senior Vice President Development and deputy CMO at Grünenthal Group where he was a key member of the Global R&D Leadership and the Global Commercial Leadership Teams. Yuri has been responsible for advancing the Grünenthal Group R&D pipeline, including two phase 3 assets, two phase 2 assets and several early and pre-clinical assets. Yuri has also been a key member and driver in several in-licensing and out-licensing activities and in the completion of the acquisition of Mestex AG.

From 2014 to 2017, Yuri was Vice President Development and Clinical Operations in Shionogi Europe, where he was a key contributor to the approval of Mulpeo (previously Lusutrombopag) and Cefiderocol.

Throughout his career, Yuri has gained a deep insight into global markets, working in Europe, the US, Middle East and Asia and has contributed to more than ten submissions for Marketing Authorisation Applications (MAA) to the EMA and New Drug Applications (NDA) to the FDA.

Yuri is a Medical Doctor by background, and also holds a PhD in Genetics and Molecular Biology, an MBA and a Master’s in Project Management. Yuri is also a fellow member of the Royal Society of Medicine.

Neil Clark, Chief Executive Officer, Destiny Pharma said: “Yuri is an important new member of our team, as he brings the right skill sets to drive the strategy, direction and execution of the Company’s Phase 3 clinical development plans as we move towards the next phase of our growth.”

Dr. Yuri Martina, Chief Medical Officer, Destiny Pharma, said: “I very much look forward to being an integral part of Destiny Pharma’s leadership management team at such a pivotal moment in the Company’s history. I feel privileged to be able to contribute to progressing the pipeline of our unique late-stage clinical assets addressing patients’ unmet needs and delivering on the Company’s strategy to build a world-leading infection prevention company.”

ENDS

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 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 www.destinypharma.com

27 April 2022 – Posting of Annual Report and Notice of AGM

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

Posting of Annual Report and Accounts, and Notice of AGM

Brighton, United Kingdom – 27 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 that the following documents are now available on the Company’s website at www.destinypharma.com

•    Annual Report and Accounts of the Company for the year ended 31 December 2021

•    Notice of the 2022 Annual General Meeting (“AGM”) which is to be held at 11.00 a.m. on 27 May, 2022 at the offices of finnCap Ltd, One Bartholomew Close, London, EC1A 7BL

Printed copies of both documents will be posted to shareholders today.

For those shareholders unable to attend the AGM in person, the Company will operate a virtual facility to allow shareholders to listen in to the business of the AGM.  However, shareholders will not be able to vote online during the meeting and are therefore urged to submit their votes via proxy as early as possible.

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 after the meeting.

Shareholders are invited to pre-submit questions online via the Investor Meet Company platform up until 11.00 a.m. on 26 May 2022, being the day before the AGM, or during the AGM 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 who wish to attend the AGM online should register for the event in advance via the following link: https://www.investormeetcompany.com/destiny-pharma-plc/register-investor.

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 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

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.

08 March 2022 – Fundraising

THIS ANNOUNCEMENT (INCLUDING THE APPENDICES) (THIS “ANNOUNCEMENT”) 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

8 March 2022

Destiny Pharma plc

Fundraising to raise up to £7.0 million

Destiny Pharma plc (AIM: DEST) (the “Company” or “Destiny Pharma”), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, today announces a conditional fundraising of up to approximately £7.0 million (before expenses) comprising the Placing, the Subscription and the Open Offer. The net proceeds of the Fundraising will allow the Company to continue progress towards Phase 3 trials in its two lead, clinical assets, NTCD-M3 and XF-73 Nasal, and finalise regulatory plans, whilst also strengthening the balance sheet as the Company progresses partnering discussions in relation to NTCD-M3.

Certain defined terms used in this Announcement are set out in Appendix III to this Announcement.

The Company has conditionally placed 11,860,000 new ordinary shares of one penny each (“Ordinary Shares”) in the capital of the Company (the “Placing Shares”) at a price of 50 pence per Placing Share (the “Issue Price”) to raise approximately £5.9 million (before expenses), (the “Placing”).

The Company also announces a subscription by certain directors of the Company (the “Directors” or the “Board”) of an aggregate 140,000 new Ordinary Shares (the “Subscription Shares”) at the Issue Price to raise £70,000 (before expenses), (the “Subscription”).

In addition to the Placing and the Subscription, Qualifying Shareholders will be given the opportunity to subscribe for an aggregate of up to 2,012,269 new Ordinary Shares (the “Open Offer Shares” and, together with the Placing Shares and the Subscription Shares, the “New Shares”) at the Issue Price through an open offer to raise up to approximately £1.0 million (before expenses), (the “Open Offer”, and together with the Placing and the Subscription, the “Fundraising”).

Highlights

·               Placing and Subscription to raise £6.0 million (before expenses) through the issue of 12,000,000 new Ordinary Shares at the Issue Price.

·               The net proceeds of the Fundraising will allow the Company to continue progress towards Phase 3 trials in its two lead, clinical assets, NTCD-M3 and XF-73 Nasal and finalise regulatory plans, whilst also strengthening the balance sheet as the Company progresses partnering discussions in relation to NTCD-M3.

·               This Fundraising comes at an important time for Destiny Pharma and the Board decided to proceed in very difficult market conditions because it was felt that any delay in activity on either of the key assets would, in the Board’s view, significantly reduce the value of both products and leave the Company in a vulnerable position.

·               The New Shares, assuming full take-up of the Open Offer, will represent approximately 18.8 per cent. of the Enlarged Share Capital following Admission.

·               The Issue Price represents a discount of approximately 28 per cent. to the closing mid-market price of 69 pence per existing Ordinary Share on 7 March 2022, being the latest practicable date prior to this Announcement.

·               Certain of the Directors have conditionally agreed to subscribe for, in aggregate, 140,000 new Ordinary Shares in the Subscription.

·               A General Meeting to approve the resolutions (the “Resolutions”) required to implement the Fundraising is to be held at 11.00 a.m. at the offices of finnCap Limited (“finnCap” or the “Broker”), One Bartholomew Close, London, EC1A 7BL on 28 March 2022 (the “General Meeting”). A detailed timetable of events is set out in Appendix I of this Announcement.

Neil Clark, CEO of the Company commented:

“We are very pleased with the results of the fundraising and the support from our existing and new shareholders. The funds will allow us to continue our progress towards the Phase 3 trials in our lead clinical assets, NTCD-M3 and XF-73 Nasal. The capital will also allow us to finalise the regulatory plans and strengthen the Company’s balance sheet as the Company progresses its partnering discussions with regards to NTCD-M3.”

finnCap is acting as nominated adviser and broker in connection with the Placing.

The Company intends to publish and send a shareholder circular (the “Circular”) to Shareholders in connection with the Open Offer in due course. The Circular will be available from the Company’s website (www.destinypharma.com) once published.

The person responsible for arranging the release of this Announcement on behalf of the Company is Shaun Claydon, Chief Financial Officer and Company Secretary of the Company.

For further information, please contact: 

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (01)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

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      


This Announcement should be read in its entirety. In particular, you should read and understand the information provided in the “Important Notices” section of this Announcement.

IMPORTANT NOTICES

MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO TAKE PART IN THE PLACING. THIS ANNOUNCEMENT IS DIRECTED ONLY AT PERSONS WHOSE ORDINARY ACTIVITIES INVOLVE THEM IN ACQUIRING, HOLDING, MANAGING AND DISPOSING OF INVESTMENTS (AS PRINCIPAL OR AGENT) FOR THE PURPOSES OF THEIR BUSINESS AND WHO HAVE PROFESSIONAL EXPERIENCE IN MATTERS RELATING TO INVESTMENTS AND ARE: (1) IF IN A MEMBER STATE OF THE EUROPEAN ECONOMIC AREA (“EEA”), QUALIFIED INVESTORS AS DEFINED IN ARTICLE 2(e) OF REGULATION (EU) 2017/1129 (THE “EU PROSPECTUS REGULATION”); (2) IF IN THE UNITED KINGDOM, QUALIFIED INVESTORS AS DEFINED IN ARTICLE 2(e) OF REGULATION (EU) 2017/1129 AS IT FORMS PART OF UNITED KINGDOM DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (THE “UK PROSPECTUS REGULATION”) WHO; (A) FALL WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005, AS AMENDED (THE “ORDER”) (INVESTMENT PROFESSIONALS) OR (B) FALL WITHIN ARTICLE 49(2)(a) TO (d) (HIGH NET WORTH COMPANIES, UNINCORPORATED ASSOCIATIONS, ETC.) OF THE ORDER; AND (3) OTHERWISE, PERSONS TO WHOM IT IS OTHERWISE LAWFUL TO COMMUNICATE IT TO (ALL SUCH PERSONS TOGETHER BEING REFERRED TO AS “RELEVANT PERSONS”).

THIS ANNOUNCEMENT AND THE INFORMATION IN IT MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. PERSONS DISTRIBUTING THIS ANNOUNCEMENT MUST SATISFY THEMSELVES THAT IT IS LAWFUL TO DO SO. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. THIS ANNOUNCEMENT DOES NOT ITSELF CONSTITUTE AN OFFER FOR SALE OR SUBSCRIPTION OF ANY SECURITIES IN DESTINY PHARMA PLC.

THE SECURITIES REFERRED TO HEREIN HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR WITH ANY SECURITIES REGULATORY AUTHORITY OF ANY STATE OR JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES (INCLUDING ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES AND THE DISTRICT OF COLUMBIA) (THE “UNITED STATES” OR THE “US”) EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THE PLACING SHARES ARE BEING OFFERED AND SOLD ONLY OUTSIDE OF THE UNITED STATES IN “OFFSHORE TRANSACTIONS” WITHIN THE MEANING OF, AND IN ACCORDANCE WITH, REGULATION S UNDER THE SECURITIES ACT AND OTHERWISE IN ACCORDANCE WITH APPLICABLE LAWS. NO PUBLIC OFFERING OF SECURITIES IS BEING MADE IN THE UNITED STATES OR ELSEWHERE.

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR 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. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE OR SUBSCRIPTION INTO THE UNITED STATES.

The distribution of this Announcement and/or the Placing and/or issue of the Placing Shares in certain jurisdictions may be restricted by law. No action has been taken by the Company, the Broker or any of their respective affiliates, agents, directors, officers, consultants, partners or employees (“Representatives”) that would permit an offer of the Placing Shares or possession or distribution of this Announcement or any other offering or publicity material relating to such Placing Shares in any jurisdiction where action for that purpose is required. Persons into whose possession this Announcement comes are required by the Company and the Broker to inform themselves about and to observe any such restrictions.

This Announcement or any part of it is for information purposes only and does not constitute or form part of any offer to issue or sell, or the solicitation of an offer to acquire, purchase or subscribe for, any securities in the United States, Australia, Canada, the Republic of South Africa or Japan or any other jurisdiction in which the same would be unlawful. No public offering of the Placing Shares is being made in any such jurisdiction.

All offers of the Placing Shares in the United Kingdom or the EEA will be made pursuant to an exemption from the requirement to produce a prospectus under the UK Prospectus Regulation. In the United Kingdom, this Announcement is being directed solely at persons in circumstances in which section 21(1) of the Financial Services and Markets Act 2000 (as amended) does not require the approval of the relevant communication by an authorised person.

The Placing Shares have not been approved or disapproved by the US Securities and Exchange Commission, any state securities commission or other regulatory authority in the United States, nor have any of the foregoing authorities passed upon or endorsed the merits of the Placing or the accuracy or adequacy of this Announcement. Any representation to the contrary is a criminal offence in the United States. The relevant clearances have not been, nor will they be, obtained from the securities commission of any province or territory of Canada, no prospectus has been lodged with, or registered by, the Australian Securities and Investments Commission or the Japanese Ministry of Finance; the relevant clearances have not been, and will not be, obtained from the South Africa Reserve Bank or any other applicable body in the Republic of South Africa in relation to the Placing Shares; and the Placing Shares have not been, nor will they be, registered under or offered in compliance with the securities laws of any state, province or territory of the United States, Australia, Canada, the Republic of South Africa or Japan. Accordingly, the Placing Shares may not (unless an exemption under the relevant securities laws is applicable) be offered, sold, resold or delivered, directly or indirectly, in or into the United States, Australia, Canada, the Republic of South Africa or Japan or any other jurisdiction outside the United Kingdom.

Persons (including, without limitation, nominees and trustees) who have a contractual right or other legal obligations to forward a copy of this Announcement should seek appropriate advice before taking any such action.

This Announcement may contain, or may be deemed to contain, “forward-looking statements” with respect to certain of the Company’s plans and its current goals and expectations relating to its future financial condition, performance, strategic initiatives, objectives and results. Forward-looking statements sometimes use words such as “aim”, “anticipate”, “target”, “expect”, “estimate”, “intend”, “plan”, “goal”, “believe”, “seek”, “may”, “could”, “outlook” or other words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company, including amongst other things, United Kingdom domestic and global economic business conditions, market-related risks such as fluctuations in interest rates and exchange rates, the policies and actions of governmental and regulatory authorities, the effect of competition, inflation, deflation, the timing effect and other uncertainties of future acquisitions or combinations within relevant industries, the effect of tax and other legislation and other regulations in the jurisdictions in which the Company and its affiliates operate, the effect of volatility in the equity, capital and credit markets on the Company’s profitability and ability to access capital and credit, a decline in the Company’s credit ratings; the effect of operational risks; and the loss of key personnel. As a result, the actual future financial condition, performance and results of the Company may differ materially from the plans, goals and expectations set forth in any forward-looking statements. Any forward-looking statements made in this Announcement by or on behalf of the Company speak only as of the date they are made. Except as required by applicable law or regulation, the Company expressly disclaims any obligation or undertaking to publish any updates or revisions to any forward-looking statements contained in this Announcement to reflect any changes in the Company’s expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based.

finnCap is authorised and regulated by the Financial Conduct Authority (the “FCA”) in the United Kingdom and is acting exclusively for the Company and no one else in connection with the Placing or any other matters referred to in this Announcement, and finnCap will not be responsible to anyone other than the Company for providing the protections afforded to its clients or for providing advice in relation to the Placing or any other matters referred to in this Announcement.

MC Sevices is authorised and regulated in Germany according to §3 (2) WpIG as a Tied Agent of CapSolutions GmbH and is acting exclusively for the Company and no one else in connection with the Placing or any other matters referred to in this Announcement, and MC Services will not be responsible to anyone other than the Company for providing the protections afforded to its clients or for providing advice in relation to the Placing or any other matters referred to in this Announcement.

No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Broker, MC Services or by any of their respective Representatives as to, or in relation to, the accuracy or completeness of this Announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefor is expressly disclaimed.

No statement in this Announcement is intended to be a profit forecast or estimate, and no statement in this Announcement should be interpreted to mean that earnings per share of the Company for the current or future financial years would necessarily match or exceed the historical published earnings per share of the Company.

The price of shares and any income expected from them may go down as well as up and investors may not get back the full amount invested upon disposal of the shares. Past performance is no guide to future performance, and persons needing advice should consult an independent financial adviser.

The New Shares to be issued pursuant to the Fundraising will not be admitted to trading on any stock exchange other than the AIM market of the London Stock Exchange.

Neither the content of the Company’s website nor any website accessible by hyperlinks on the Company’s website is incorporated in, or forms part of, this Announcement.

Information to Distributors

Solely for the purposes of the product governance requirements contained within Chapter 3 of the FCA Handbook Production Intervention and Product Governance Sourcebook (the “UK Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the UK Product Governance Requirements) may otherwise have with respect thereto, the New Shares have been subject to a product approval process, which has determined that such securities are: (i) compatible with an end target market of investors who meet the criteria of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in paragraph 3 of the FCA Handbook Conduct of Business Sourcebook; and (ii) eligible for distribution through all distribution channels (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors (for the purposes of UK Product Governance Requirements) should note that: (a) the price of the New Shares may decline and investors could lose all or part of their investment; (b) the New Shares offer no guaranteed income and no capital protection; and (c) an investment in the New Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom.  The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Fundraising.  Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Broker will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of Chapter 9A or 10A respectively of the FCA Handbook Conduct of Business Sourcebook; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the New Shares.

Each distributor is responsible for undertaking its own Target Market Assessment in respect of the New Shares and determining appropriate distribution channels.

The following is an extract from the Chairman’s letter to be set out in substantially the same form in the Circular.

1.   “Introduction”

The Company has conditionally raised £6.0 million, before expenses, by way of a Placing of 11,860,000 Placing Shares and a Subscription of 140,000 Subscription Shares, in each case, at a price of 50 pence per share.

In addition, in order to provide Shareholders who have not taken part in the Placing or the Subscription with an opportunity to participate in the proposed issue of New Shares, the Company is providing all Qualifying Shareholders with the opportunity to subscribe for an aggregate of up to 2,012,269 Open Offer Shares, to raise up to approximately £1.0 million (before expenses), on the basis of 1 Open Offer Share for every 30 Existing Ordinary Shares held on the Record Date, at 50 pence per share. Shareholders subscribing for their full entitlement under the Open Offer may also request additional Open Offer Shares through the Excess Application Facility.

The total amount that the Company could raise under the Fundraising is approximately £7.0 million (before expenses), assuming that the Open Offer is fully subscribed.

The net proceeds of the Fundraising will allow the Company to continue progress towards Phase 3 trials in its two lead, clinical assets, NTCD-M3 and XF-73 Nasal and finalise regulatory plans, whilst also strengthening the balance sheet as the Company progresses partnering discussions with regards to NTCD-M3.

finnCap has conditionally agreed, pursuant to the terms of the Placing Agreement, to use its reasonable endeavours to procure Placees to subscribe for the 11,860,000 Placing Shares at the Issue Price. The Placing Shares are not subject to clawback and are not part of the Open Offer. Neither the Placing nor the Open Offer are being underwritten.

Each of Neil Clark, Shaun Claydon, Nick Rodgers and Debra Barker are participating in the Fundraise and have agreed to subscribe for 140,000 Subscription Shares in aggregate at the Issue Price. The Directors will not take up any entitlements they have under the Open Offer.

The Placing, the Subscription and the issue of the Open Offer Shares are conditional, inter alia, on the passing by Shareholders of the Resolutions at the General Meeting, which is being convened for 11 a.m. on 28 March 2022.

As part of the Fundraising, the Company is seeking to raise funds by the issue of certain Placing Shares to investors seeking the benefit of relief under the Enterprise Investment Scheme and certain Placing Shares to investors seeking the benefit of tax relief through VCT. The issue of both the Placing Shares and the Subscription Shares are subject to the passing of the Resolutions at a General Meeting. The issue of the Subscription Shares, the Open Offer Shares and the Placing Shares is conditional upon Admission.

For avoidance of doubt, the Open Offer Shares will not be eligible for relief under the Enterprise Investment Scheme or VCT Schemes.

Application will be made to the London Stock Exchange for the New Shares to be admitted to trading on AIM. It is expected that Admission will become effective and that dealings in the New Shares will commence at 8.00 a.m. on 29 March 2022 (being the business day following the General Meeting) or such later time and/or dates as the Company and finnCap may agree (being in any event no later than 8.00 a.m. on 15 April 2022).

If the conditions relating to the issue of the Placing Shares are not satisfied, or the Placing Agreement is terminated in accordance with its terms, the Placing Shares will not be issued and the Company will not receive the related placing monies.

2.   Background to and Reasons for the Fundraising

Background on the Company

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development and commercialisation of novel medicines that can prevent life-threatening infections. The Company’s legacy asset, XF-73 Nasal, is targeting the prevention of post-surgical hospital infections caused by Staphylococcal aureus, including MRSA. Following the positive Phase 2 clinical results announced in H1 2021, the Company has been in advanced discussions with regulatory authorities in Europe and the US. These important discussions will help clarify the design, size and cost of the final Phase 3 clinical trials needed prior to registration. It is anticipated that there will be different Phase 3 requirements and therefore the Company expects that two Phase 3 programmes will be expected. It is likely that feedback from EMA (European Medicines Authority) will be received before the US FDA (Food and Drug Administration). The Company expects to receive feedback from the EMA and the FDA during Q2 2022 and is confident that getting clarity on the final Phase 3 studies will help secure partnering agreements. The Company is targeting commencement of these Phase 3 studies in 2023.

The Company also recently commissioned an independent European market research study, the findings of which reinforce the clinical support and market potential of XF-73 nasal gel in Europe. Based on the key fundamentals of clinical need, efficacy, ease of use and value for money, the Company is confident that there is a good European commercial opportunity in addition to the large US market for XF-73 nasal gel. The Company estimates that global peak sales for XF-73 nasal gel could exceed US$1 billion with the US being half of the total market opportunity.

In November 2020, the Company acquired the global rights to NTCD-M3, a Phase 3 ready asset targeting the prevention of C. difficile infection (CDI) recurrence, the leading cause of hospital acquired infection in the U.S. By acquiring the global rights for NTCD-M3, the Company extended its microbiome portfolio alongside the SPOR-COV COVID-19 project that was added in September 2020. The acquisition strengthened further the Company’s focus on the prevention of infections and fits well with the Board’s strategy to build a world leading anti-infection Company.

NTCD-M3 is the world’s first, single strain, live biotherapeutic product being developed to reduce the recurrence of CDI in the gut which is targeted to start Phase 3 trials by the end of 2022. Good progress was made in 2021 with the transfer and commencement of the manufacturing scale up process for NTCD-M3. This is a key project requirement and needs to be delivered to a high standard at high volumes. The Company’s clinical team is also finalising the detail of the Phase 3 clinical trial design and expects to conclude discussions with US and European regulators during the first half of 2022. Additionally, supportive microbiological research studies using NTCD-M3 are also underway, and positive results were announced in the first quarter of 2022.

A number of competitor CDI projects delivered clinical trial results in 2021 including companies using faecal matter, bacterial consortia and antibiotic approaches. The results and data reported were encouraging for the Company and the Company remains confident in the superior profile and potential positioning of NTCD-M3 as a targeted, safe, effective and easy to use biotherapeutic preventive treatment. NTCD-M3 has delivered excellent clinical data from previously reported Phase 2 studies showing that it significantly reduces the levels of recurrence in CDI patients. The Company remains very positive that when the planned Phase 3 trials deliver similar results that NTCD-M3 can become a breakthrough product to prevent the recurrence of CDI. This is a substantial commercial opportunity that the Company estimates could lead to peak sales of up to US$500 million in the US alone.

The Company is making good progress in discussions with potential licensing partners for NTCD-M3, with several potential partners active in a data room. This is in line with the Company’s stated strategy of seeking partners to help co-fund the required Phase 3 trials and lead commercialisation.

Good progress has also been made with the Company’s joint partner SporeGen Limited in carrying out the pre-clinical work on SPOR-COV, the novel bacterial formulation designed to prevent coronavirus and other viral respiratory infections (including COVID-19 and influenza) by stimulating the innate immune system using a simple nasal spray. The work is largely funded by an £800,000 Innovate UK grant. SPOR-COV is being tested in COVID-19 and influenza infection models and the project is due to complete in Q1 2022. Plans for the next stage of development are being progressed to maintain momentum in the project after the grant funded work is completed.

The Company has two active dermal infection research programmes using new XF-73 formulations that are continuing in 2022; one is funded by a US government group and the other by CMS in China.

The Company also has several XF platform research projects that are progressing well and are largely funded by grants and non-dilutive funding.

3.   Use of Proceeds

Use of Proceeds 

 

NTCD-M3

CMC manufacturing/final Phase 3 clinical trial preparation

£3.0 million

XF-73 Nasal

CMC manufacturing/ Phase 3 clinical trial preparation

£1.0 million

XF-73 Dermal

Second stage of CF-73 dermal project (accesses $1m NDF from NIAID)/support transition of SPOR-COV project into human studies

£0.5 million

General working capital/ strengthening of balance sheet

£1.5 – 2.5 million

 Total

£6.0 million (plus up to £1.0 million in Open Offer)

4.   Current Trading

As announced on 17 January 2022, the Company continues to make considerable progress with its late-stage clinical assets and earlier research programmes. The Company remains focused on finalising the Phase 3 trial plans for its two late-stage clinical assets and closing partnering deals.

5.   Details of the Fundraise

The Company has conditionally placed 11,860,000 Placing Shares pursuant to the Placing at the Issue Price, which represents a discount of approximately 28 per cent. to the closing mid-market price of 69 pence per Existing Ordinary Share on 7 March 2022, being the latest practicable date prior to the date of the announcement of the Fundraise.

In addition, each of Neil Clark, Shaun Claydon, Nick Rodgers and Debra Barker are participating in the Fundraise and have agreed to subscribe for 140,000 Subscription Shares in aggregate at the Issue Price.

Alongside the Placing, the Company is making an Open Offer pursuant to which it may raise a further amount of up to approximately £1.0 million (before expenses). The proposed issue price of 50 pence per Open Offer Share is the same price as the price at which New Shares are being issued pursuant to the Placing.

The maximum aggregate number of New Shares that may be issued pursuant to the Fundraise is 14,012,269 new Ordinary Shares, representing approximately 18.8 per cent of the Enlarged Share Capital following Admission.

Details of the Placing

finnCap, as agent of the Company, has conditionally placed the Placing Shares at the Issue Price with existing Shareholders and other institutional investors, representing gross proceeds of approximately £5.9 million. The Placing will comprise 11,860,000 Placing Shares.

As part of the Fundraising, the Company is seeking to raise funds by the issue of certain Placing Shares to investors seeking the benefit of relief under the Enterprise Investment Scheme and certain Placing Shares to investors seeking the benefit of tax relief through VCT. The issue of both the Placing Shares and the Subscription Shares are subject to the passing of the Resolutions at a General Meeting. The issue of the Subscription Shares, the Open Offer Shares and the Placing Shares are conditional upon Admission.

The Placing Shares will, when issued and fully paid, rank pari passu in all respects with the Ordinary Shares in issue at that time, including the right to receive all dividends and other distributions declared, made or paid after the date of Admission. The Placing Shares are not subject to clawback and are not part of the Open Offer. The Placing is not underwritten.

The Placing Agreement

Pursuant to the terms of the Placing Agreement, finnCap, as agent of the Company, has conditionally agreed to use its reasonable endeavours to procure subscribers for the Placing Shares at the Issue Price. The Placing Agreement is conditional upon, inter alia, the Resolutions being duly passed at the General Meeting, and Admission becoming effective on or before 8.00 a.m. on 29 March 2022 (or such later time and/or date as the Company and finnCap may agree, but in any event by no later than 8.00 a.m. on 15 April 2022).

The Placing Agreement contains customary warranties from the Company in favour of finnCap in relation to, inter alia, the accuracy of the information in the Circular and other matters relating to the Company and its business.  In addition, the Company has agreed to indemnify finnCap in relation to certain defined liabilities that it may incur in respect of the Fundraising.

finnCap has the right to terminate the Placing Agreement in certain circumstances prior to Admission. in particular, in the event of a material breach of the warranties given to finnCap in the Placing Agreement or a material adverse change affecting the business, financial trading position or prospects of the Company.

The Placing Agreement also provides for the Company to pay all costs, charges and expenses of, or incidental to, the Placing and Admission including all legal fees (up to an agreed cap) and other professional fees and expenses.

The Placing Shares have not been made available to the public and have not been offered or sold in any jurisdiction where it would be unlawful to do so.

Details of the Subscription and Directors’ participation

The Company has conditionally raised £70,000 (before expenses) through the issue of 140,000 new Ordinary Shares at the Issue Price, pursuant to the Subscription.

The Subscription has not been underwritten and, pursuant to the Subscription Letters, is conditional, inter alia, upon:

i.   the Placing Agreement having become unconditional in all respects (save for the conditions relating to the Subscription) and not having been terminated;

ii.  Admission occurring by not later than 8.00 a.m. on 29 March 2022 (or such later time and/or date as the Company and finnCap may agree, not being later than 15 April 2022).

Accordingly, if any such conditions are not satisfied or, if applicable, waived (if capable of waiver), the Subscription will not proceed.

Directors Neil Clark, Shaun Claydon, Nick Rodgers and Debra Barker have conditionally agreed to subscribe for an aggregate of 140,000 Subscription Shares as set out below.

Director

Position

Current Number of Ordinary Shares

Current % Holding

Number of Shares subscribed for in the Fundraising

Resultant holding of the Enlarged Share Capital %*

Neil Clark

Chief Executive Officer

38,462

0.06%

50,000

0.12%

Shaun Claydon

Chief Financial Officer and Company Secretary

10,000

0.01%

Nick Rodgers

Chairman

56,073

0.09%

50,000

0.14%

Debra Barker

Non-Executive Director

38,461

0.06%

30,000

0.09%

*assuming full take-up of the Open Offer Shares

Details of the Open Offer

Subject to the fulfilment of the conditions set out below, Qualifying Shareholders may subscribe for Open Offer Shares in proportion to their holding of Existing Ordinary Shares held on the Record Date. Shareholders subscribing for their full entitlement under the Open Offer may also request additional Open Offer Shares as an Excess Entitlement, up to the total number of Open Offer Shares available to Qualifying Shareholders under the Open Offer.

The Open Offer is conditional, inter alia, on the Placing becoming unconditional in all respects and not being terminated before Admission. The principal terms of the Placing are:

i.    the Resolutions being passed at the General Meeting;

ii.   the Placing Agreement having become unconditional (save for Admission) and not having been terminated in accordance with its terms prior to General Admission; and

iii.  Admission becoming effective on or before 8.00 a.m. on 29 March 2022 (or such later date and/or time as the Company and finnCap may agree, being no later than 15 April 2022).

Basic Entitlement

On, and subject to the terms and conditions of the Open Offer, the Company invites Qualifying Shareholders to apply for their Basic Entitlement of Open Offer Shares at the Issue Price. Each Qualifying Shareholder’s Basic Entitlement has been calculated on the following basis:

1 Open Offer Share for every 30 Existing Ordinary Shares held at the Record Date

Basic Entitlements will be rounded down to the nearest whole number of Ordinary Shares.

Excess Entitlement

Qualifying Shareholders are also invited to apply for additional Open Offer Shares (up to the total number of Open Offer Shares available to Qualifying Shareholders under the Open Offer) as an Excess Entitlement. Any Open Offer Shares not issued to a Qualifying Shareholder pursuant to their Basic Entitlement will be apportioned between those Qualifying Shareholders who have applied for an Excess Entitlement at the sole discretion of the Board, provided that no Qualifying Shareholder shall be required to subscribe for more Open Offer Shares than he or she has specified on the Application Form or through CREST.

Qualifying CREST Shareholder stock accounts will be credited as soon as possible after 8.00 a.m. on 10 March 2022 with Basic and Excess Entitlements in such Qualifying CREST Shareholder’s name as at the Record Date.

Shareholders with no basic entitlement cannot apply for excess shares.

The Open Offer Shares will, when issued and fully paid, rank pari passu in all respects with the Ordinary Shares in issue at that time, including the right to receive all dividends and other distributions declared, made or paid after the date of Admission. The Open Offer is not underwritten.

Qualifying Shareholders should note that the Open Offer is not a “rights issue”. Invitations to apply under the Open Offer are not transferable unless to satisfy bona fide market claims. Qualifying non-CREST Shareholders should be aware that the Application Form is not a negotiable document and cannot be traded. Qualifying Shareholders should also be aware that in the Open Offer, unlike in a rights issue, any Open Offer Shares not applied for will not be sold in the market nor will they be placed for the benefit of Qualifying Shareholders who do not apply for Open Offer Shares under the Open Offer.

Settlement and dealings

Application will be made to the London Stock Exchange for the New Shares to be admitted to trading on AIM. It is expected that Admission will become effective at 8.00 a.m. on 29 March 2022.

Overseas Shareholders

The Open Offer Shares have not been and are not intended to be registered or qualified for sale in any jurisdiction other than the United Kingdom. Accordingly, unless otherwise determined by the Company and effected by the Company in a lawful manner, the Application Form will not be sent to Shareholders with registered addresses in, or who are resident or located in the United States or another Restricted Jurisdiction since to do so would require compliance with the relevant securities laws of that jurisdiction. The Company reserves the right to treat as invalid any application or purported application for Open Offer Shares which appears to the Company or its agents or professional advisers to have been executed, effected or dispatched in a manner which may involve a breach of the laws or regulations of any jurisdiction or if the Company or its agents or professional advisers believe that the same may violate applicable legal or regulatory requirements or if it provides an address for delivery of share certificates for Open Offer Shares outside the UK, or in the case of a credit of Open Offer Shares in CREST, to a CREST member whose registered address would not be in the UK.

Notwithstanding the foregoing and any other provision of this document or the Application Form, the Company reserves the right to permit any Qualifying Shareholder to apply for Open Offer Shares if the Company, in its sole and absolute discretion, is satisfied that the transaction in question is exempt from, or not subject to, the legislation or regulations giving rise to the restrictions in question.

If a Qualifying Shareholder does not wish to apply for Open Offer Shares he should not complete or return the Application Form or send a USE message through CREST.

Qualifying non-CREST Shareholders

If you are a Qualifying non-CREST Shareholder you will have received a personalised Application Form, which accompanies the Circular and which gives details of your Basic Entitlement (as shown by the number of the Open Offer Shares allocated to you). If you wish to apply for Open Offer Shares under the Open Offer you should complete the accompanying Application Form in accordance with the procedure for application set out in the Circular and on the Application Form itself. The completed Application Form, accompanied by full payment, should be returned by post, or by hand (during normal business hours only), to the receiving agent Link Group, Corporate Actions, 10th Floor, Central Square, 29 Wellington Street, Leeds, LS1 4DL, so as to arrive as soon as possible and in any event no later than 11.00 a.m. on 24 March 2022.

Qualifying CREST Shareholders

Application will be made for the Open Offer Entitlements of Qualifying CREST Shareholders to be credited to stock accounts in CREST. It is expected that the Open Offer Entitlements will be credited to stock accounts in CREST on 10 March 2022. Applications through the CREST system may only be made by the Qualifying CREST Shareholder originally entitled or by a person entitled by virtue of a bona fide market claim. If you are a Qualifying CREST Shareholder, no Application Form is enclosed but you will receive credits to your appropriate stock account in CREST in respect of the Basic Entitlements to which you are entitled. You should refer to the procedure for application set out in the Circular. The relevant CREST instruction must have settled by no later than 11.00 a.m. on 24 March 2022.

6.   Related Party Transactions

The issue of Subscription Shares to Neil Clark, Shaun Claydon, Nick Rodgers and Debra Barker constitutes a related party transaction pursuant to Rule 13 of the AIM Rules by virtue of their status as Directors of the Company. William Love, Peter Morgan and Huaizheng Peng, being the independent directors for this purpose, consider, having consulted with the Company’s nominated adviser, finnCap, that the terms of the Subscription with such related parties is fair and reasonable insofar as the Company’s Shareholders are concerned.

7.   General Meeting

You will find set out at the end of the Circular a notice convening the General Meeting to be held at the offices of finnCap Ltd, 1 Bartholomew Close, London, EC1A 7BL on 28 March 2022 at 11.00 a.m. where the following Resolutions will be proposed:

Resolution 1 – An ordinary resolution, which is conditional upon the passing of Resolution 2, to authorise the Directors to allot the New Shares in connection with the Fundraise.

Resolution 2 – A special resolution, which is conditional upon the passing of Resolution 1, which dis-applies statutory pre-emption rights in respect of the allotment of the New Shares in connection with the Fundraise.

The authorities and the powers described in Resolutions 1 and 2 above will (unless previously revoked or varied by the Company in general meeting) expire on the date 3 months from the passing of such Resolutions or at the conclusion of the next annual general meeting of the Company following the passing of the Resolutions, whichever occurs first. The authority and the power described in Resolutions 1 and 2 above are in addition to any like authority or power previously conferred on the Directors.

8.   Recommendation

Your Directors consider that the Fundraise and the authorities granted by the Resolutions are in the best interests of the Company and its Shareholders as a whole. Accordingly, your Directors  unanimously recommend that you vote in favour of the Resolutions as they intend to do in respect of their own shareholdings of 7,667,996 Ordinary Shares, representing approximately 12.7 per cent. of the Company’s current issued share capital.”

APPENDIX I – EXPECTED TIMETABLE OF PRINCIPAL EVENTS

Record Date for entitlements under the Open Offer

 Close of business

   7 March 2022

Announcement of the Proposed Placing, Open Offer and Subscription

  

   8 March 2022

Ex-entitlement Date of the Open Offer

8.00 a.m. on

   9 March 2022

Posting of the Circular (including Notice of General Meeting), Form of Proxy and, to Qualifying Non-Crest Shareholders, the Application Form

   9 March 2022

Open Offer Entitlements and Excess Entitlements credited to stock accounts in CREST of Qualifying CREST Shareholders

   8.00 a.m. on

   10 March 2022

Recommended latest time and date for requesting withdrawal of Open Offer Entitlements and Excess Entitlements from CREST

4.30 p.m. on

 18 March 2022

Latest time and date for depositing Open Offer Entitlements and Excess Entitlements into CREST

3.00 p.m. on

 21 March 2022

Latest time and date for splitting Application Forms (to satisfy bona fide market claims only)

3.00 p.m. on

 22 March 2022

Latest time and date for receipt of completed Application Forms and payment in full under the Open Offer or settlement of relevant CREST instructions (as appropriate)

11.00 a.m. on

 24 March 2022

Latest time and date for receipt of CREST proxy instructions and registration of online votes from Shareholders for General Meeting

10.00 a.m. on

 24 March 2022

Latest time and date for receipt of Forms of Proxy

10.00 a.m. on

 24 March 2022

General Meeting

11.00 a.m. on

 28 March 2022

Announcement of the results of the General Meeting and the Open Offer

 28 March 2022

Admission and commencement of dealings in the New Shares

     8.00 a.m. on

 29 March 2022

New Shares in uncertificated form expected to be credited to accounts in CREST

As soon as possible after 8.00 a.m.

29 March 2022

Despatch of definitive share certificates for the New Shares in certificated form

  Within 5 business days of
the Admission

APPENDIX II – SHARE CAPITAL AND FUNDRAISE STATISTICS

Issue Price for each New Share

50 pence

Number of Existing Ordinary Shares in issue

60,368,098

Number of Placing Shares to be issued pursuant to the Placing

11,860,000

Number of Subscription Shares to be issued pursuant to the Subscription

140,000

Basis of Open Offer

1 New Share for every 30 Existing Ordinary Shares

Maximum number of Open Offer Shares to be issued pursuant to the Open Offer (assuming take-up in full of the Open Offer by Qualifying Shareholders)

2,012,269

Total New Shares to be issued*

14,012,269

Enlarged Share Capital immediately following Admission*

74,380,367

Market capitalisation at Issue Price*

 £36.2 million

New Shares as a percentage of the Enlarged Share Capital*

18.8 per cent.

Estimated gross proceeds of the Fundraising*

up to £7.0 million

Estimated net proceeds of the Fundraising*

up to £6.6 million

ISIN – Ordinary Shares

GB00BDHSP575

ISIN – Open Offer Basic Entitlements

GB00BN0W6423

ISIN – Open Offer Excess Entitlements

GB00BN0W6530

*             assuming take-up in full of the Open Offer by Qualifying Shareholders

 APPENDIX III – DEFINITIONS

Act

the Companies Act 2006 (as amended)

Admission

admission of the New Shares to trading on AIM becoming effective in accordance with the AIM Rules

AIM

the market of that name operated by the London Stock Exchange

AIM Rules

the AIM Rules for Companies governing the admission to and operation of AIM published by the London Stock Exchange as amended from time to time

AIM Rules for Nominated Advisers

the AIM Rules for Nominated Advisers published by the London Stock Exchange as amended from time to time

Applicant

a Qualifying Shareholder or a person by virtue of a bona fide market claim who lodges an Application Form or relevant CREST instruction under the Open Offer

Application Form

the application form relating to the Open Offer and accompanying the Circular for use by Qualifying non-CREST Shareholders

Articles

the articles of association of the Company in force

Basic Entitlement(s)

the pro rata entitlement for Qualifying Shareholders to subscribe for Open Offer Shares, pursuant to the Open Offer

Board or Directors

the directors of the Company

CCSS

the CREST Courier and Sorting Service, established by Euroclear to facilitate, inter alia, the deposit and withdrawal of certificated securities

certified or in certificated form

in relation to a share or other security, a share or other security that is not in uncertificated form, that is not in CREST

Company or Destiny Pharma

Destiny Pharma plc, a company incorporated in England and Wales with company number 03167025 whose registered office is at Sussex Innovation Centre, Science Park Square, Falmer, Brighton, BN1 9SB

CREST

the relevant system (as defined in the CREST Regulations 2001) for the paperless settlement of trades and the holding of uncertificated securities, operated by Euroclear, in accordance with the same regulations

CREST Manual

the rules governing the operation of CREST, as published by Euroclear

CREST member

a person who has been admitted by Euroclear as a system-member (as defined in the CREST Regulations)

CREST participant

a person who is, in relation to CREST, a system participant (as defined in the CREST Regulations)

CREST payment

shall have the meaning given in the CREST Manual issued by Euroclear

CREST Regulations

the Uncertified Securities Regulations 2001 (SI 2001 No. 3875), as amended

CREST sponsor

a CREST participant admitted to CREST as a CREST sponsor

CREST sponsored member

a CREST member admitted to CREST as a sponsored member (which includes all CREST Personal Members)

Disclosure and Transparency Rules

the disclosure guidance and transparency rules of the FCA as amended from time to time

EEA

the European Economic Area

EIS

Enterprise Investment Scheme

Enlarged Share Capital

the issued Ordinary Share capital of the Company immediately following Admission, assuming the maximum number of New Shares are issued

EU

the European Union

Euroclear

Euroclear UK & International Limited, the operator of CREST

Excess Entitlement(s)

Open Offer Shares in excess of the Basic Entitlement, but not in excess of the total number of Open Offer Shares, allocated to a Qualifying Shareholder pursuant to the Open Offer

Excess Application Facility

the arrangement pursuant to which Qualifying Shareholders may apply for additional Open Offer Shares in excess of the Basic Entitlement in accordance with the terms and conditions of the Open Offer

Excess CREST Open Offer Entitlement

in respect of each Qualifying CREST Shareholder, the entitlement to apply for Open Offer Shares in addition to the Basic Entitlement credited to the Qualifying CREST Shareholder’s account in CREST, pursuant to the Excess Application Facility, which is conditional on the Qualifying CREST Shareholder taking up his Basic Entitlement in full and which may be subject to scaleback in accordance with the provisions of the Circular

Excess Shares

the Open Offer Shares for which Qualifying Shareholders may apply under the Excess Application Facility in addition to their Basic Entitlement

Ex-entitlement Date

the date on which the Existing Ordinary Shares are marked ‘ex’ for entitlement under the Open Offer being 9 March 2022

Existing Ordinary Shares

the 60,368,098 Ordinary Shares in issue being the entire issued share capital of the Company prior to the Fundraise

FCA

the Financial Conduct Authority of the UK

finnCap

finnCap Ltd, the Company’s Nominated Adviser and Joint Broker

Form of Proxy

the form of proxy which accompanies the Circular for use in connection with the General Meeting

FSMA

the Financial Services and Markets Act 2000 (as amended)

Fundraising or Fundraise

together the Placing, the Subscription and the Open Offer

General Meeting

the general meeting of the Company, to be held at 11.00 a.m. on 28 March 2022 at the offices of finnCap Ltd, 1 Bartholomew Close, London, EC1A 7BL

HMRC

Her Majesty’s Revenue & Customs

ISIN

International Securities Identification Number

Issue Price

50 pence per New Share

London Stock Exchange

London Stock Exchange plc

Link Group

a trading name of Link Market Services

Member Account ID

the identification code or number attached to any member account in CREST

MC Services

MC Services AG as a Tied Agent of CapSolutions GmbH

Money Laundering Regulations

The Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer) Regulations 2017, as amended

New Shares

up to 14,012,269 new Ordinary Shares to be issued pursuant to the Fundraise (being the Placing Shares, the Subscription Shares and the Open Offer Shares)

Notice of General Meeting

the notice convening the General Meeting set out at the end of the Circular

NTCD-M3

a comprehensive research and clinical data set relating to an oral formulation of spores of a non-toxigenic strain of C.difficile (REA type M3)

Official List

the Official List of the FCA

Open Offer

the conditional invitation to Qualifying Shareholders to apply for the Open Offer Shares at the Issue Price on the terms and conditions outlined in the Circular and, where relevant, in the Application Form

Open Offer Entitlements

entitlements for Qualifying Shareholders to subscribe for Open Offer Shares pursuant to the Basic Entitlement and the Excess Entitlement

Open Offer Shares

up to 2,012,269 new Ordinary Shares to be issued pursuant to the Open Offer

Ordinary Shares

ordinary shares of one penny each in the capital of the Company having the rights and being subject to the restrictions contained in the Articles

Overseas Shareholders

Shareholders with registered addresses, or who are citizens or residents of, or incorporated in Restricted Jurisdictions

Participant ID

the identification code or membership number used in CREST to identify a particular CREST member or other CREST participant

Placees

any person who has agreed to subscribe for Placing Shares

Placing

the placing by finnCap, as agent of and on behalf of the Company, of the Placing Shares at the Issue Price on the terms and subject to the conditions in the Placing Agreement

Placing Agreement

the conditional agreement dated 8 March 2022 between the Company and finnCap

Placing Shares

the 11,860,000 Placing Shares to be issued pursuant to the Placing

Prospectus Regulation Rules

the prospectus regulation rules made by the FCA pursuant to section 73A of the FSMA

Publicly Available Information

any information published by the Company using a Regulatory Information Service

Qualifying CREST Shareholders

Qualifying Shareholders holding Existing Ordinary Shares which, on the register of members of the Company on the Record Date, are in uncertificated form in CREST

Qualifying Non-CREST Shareholders

Qualifying Shareholders holding Existing Ordinary Shares which, on the register of members of the Company on the Record Date, are in certificated form

Qualifying Shareholders

holders of Existing Ordinary Shares other than Overseas Shareholders, whose names appear on the register of members of the Company on the Record Date as holders of Existing Ordinary Shares and who are eligible to be offered Open Offer Shares under the Open Offer

Receiving Agent or Registrar

Link Group a trading name of Link Market Services Limited

Record Date

7 March 2022

Regulatory Information Service

a service approved by the FCA for the distribution to the public of AIM announcements and included within the list on the website of the FCA

Resolutions

the resolutions set out in the Notice of General Meeting

Restricted Jurisdictions

the United States, Australia, Canada, Japan, the Republic of South Africa and any other jurisdiction where the extension or availability of the Open Offer would breach any applicable law

Securities Act

the United States Securities Act of 1933, as amended

Shareholders

registered holders of Ordinary Shares

SPOR-COV

a novel bacterial formulation designed to prevent coronavirus and other viral respiratory infections

Subscribers

Neil Clark, Shaun Claydon, Nick Rodgers and Debra Barker, each a Director

Subscription

 

the conditional direct subscription for Subscription Shares at the Issue Price in accordance with the Subscription Letters

Subscription Letters

the subscription letters dated on or about 8 March 2022 between the Company and the Subscribers

Subscription Shares

the 140,000 new Ordinary Shares to be issued pursuant to the Subscription

UK

the United Kingdom of Great Britain and Northern Ireland

uncertificated or in uncertificated form

a share or other security recorded on the relevant register of the share or security concerned as being held in uncertificated from in CREST and title to which, by virtue of the CREST Regulations, may be transferred by means of CREST

US or United States

the United States of America, its territories and possessions, any state of the United States and the District of Columbia

USE

unmatched stock event

VCT

Venture Capital Trusts

A reference to £ is to pounds sterling, being the lawful currency of the UK.

A reference to $ or US$ is to United States dollars, being the lawful currency of the US.

A reference to € or Euro is to the lawful currency of the Euro area.

 

08 February 2022 – Positive feedback from EMA on XF-73 Nasal gel Phase 3 programme

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

Positive feedback from European Medicines Agency on XF-73 Nasal gel Phase 3 programme

Phase 3 can use similar primary endpoint to the very successful Phase 2b clinical study

New European report underpins clinical need and market opportunity of XF-73 Nasal

Brighton, United Kingdom, 8 February 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, has received positive Scientific Advice from the European Medicines Agency (EMA) following its review of Destiny Pharma’s proposed Phase 3 clinical programme design. This pivotal Phase 3 programme is expected to lead to the registration of the XF-73 nasal gel as a new drug in Europe.

The Company also announces findings from a recently commissioned, independent market research study which reinforces the clinical support and market potential of XF-73 Nasal gel in Europe.

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.

The key highlights of the EMA advice are as follow:

  • A simple, microbiological primary endpoint is acceptable for European approval of the XF-73 nasal gel. It will measure the percentage of patients demonstrating decolonisation to a level of eradication. This is consistent with the primary endpoint used in the very successful Phase 2b clinical study that reported outstanding results in 2021.
  • Agreement that the patient population to enroll in the Phase 3 trials will be those who are nasal carriers of aureus (approximately a third of all patients) undergoing surgeries that put them at risk of a post-surgical S. aureus or MRSA infection. This is consistent with the patient population enrolled in the successful Phase 2b.
  • It has been agreed that in Europe XF-73 Nasal gel would be compared to a “standard of care” mupirocin treatment in the Phase 3 programme; mupirocin is the old dermal antibiotic widely used across the world for nasal decolonisation.
  • Agreement with the proposed XF-73 Nasal gel product pack approach for Phase 3 and its commercial suitability for the European market.

This positive advice is welcomed by the Company as it identifies a clear route through European approval of XF-73 Nasal gel as a ground-breaking hospital infection prevention product.

The Company is also in discussions with the FDA on a study design suitable to gain US approval which, combined with the EMA feedback, will finalise the global Phase 3 clinical strategy for the XF-73 Nasal gel product. XF-73 has been awarded both Qualified Infectious Disease Product (QIDP) and Fast Track status by the US Food & Drug Administration (FDA).

Qualitative market research

The external, independent findings of this research show that XF-73 Nasal gel is seen as a very promising alternative to the current standard of treatment, mupirocin, by both clinicians and payers. By addressing the unmet needs associated with mupirocin’s continued use, the study suggests XF-73 has the potential to replace the current standard of treatment as the preferred pre-surgical nasal decolonisation agent. Key to this is its one-day dosing which would improve patient compliance, enable use in emergency surgery and reduce pre-surgical preparation time for elective surgeries. XF-73 also has activity against a wider spectrum of Staphylococcal strains including MRSA strains while mupirocin resistance is increasing.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased with the detailed feedback received from EMA on the Phase 3 clinical trial plans for our XF-73 Nasal gel product. These studies will be the final step before registration in Europe. We are also continuing our discussions with the FDA to discuss our proposal for Phase 3 designs in US. This is a very exciting time for the XF-73 Nasal gel product since finalising these study designs will provide clarity on the clinical trial size and costs, which are key to securing partners for the programme. The Company remains very confident in the significant value of the XF-73 Nasal gel programme based on the excellent clinical data produced to date and the clear clinical need and significant market opportunity indicated by external, independent market experts. The Company estimates that peak sales could exceed US$ 1 billion in the US alone.”

For further information, please contact:

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

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

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

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

About Destiny Pharma

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

For further information, please visit  www.destinypharma.com

About XF-73

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

Forward looking statements

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