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

24 February 2023

Destiny Pharma plc

Fundraising to raise up to £8 million

Destiny Pharma plc (AIM: DEST) (the “Company” or “Destiny Pharma”), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces a conditional fundraising of up to approximately £8 million (before expenses) comprising a Placing, Subscription and an Open Offer (each as defined below). The net proceeds of the Fundraising will allow the Company to complete final Phase 3 clinical trial preparation for NTCD-M3, including clinical trial material manufacturing; progress XF-73 Nasal CMC manufacturing and Phase 3 preparation; to further progress its preclinical projects; and to provide general working capital to strengthen the balance sheet, which is a condition of the Collaboration and Co-development agreement with Sebela Pharmaceuticals as announced earlier today.

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

The Company has placed new ordinary shares of one pence each (“Ordinary Shares”) in the capital of the Company (the “Placing Shares”) at a price of 35 pence per Placing Share (the “Issue Price”) to raise approximately £7 million (before expenses), (the “Placing”). Of the Placing Shares, 14,285,714 new ordinary shares are being allotted out of existing share authorities and will be admitted on 1 March 2023 the remaining 5,714,286 new ordinary shares will be subject to approval by Shareholders of the requisite authorities at the General Meeting on 16 March 2023.

The Company also announces a conditional subscription by certain directors of the Company (the “Directors” or the “Board”) of an aggregate 71,428 new Ordinary Shares (the “Subscription Shares”) at the Issue Price to raise £25,000 (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 2,938,284 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 million (before expenses), (the “Open Offer”, and together with the Placing and the Subscription, the “Fundraising”).

It is intended that the Circular to Shareholders will be posted on 28 February 2023.

Highlights

Neil Clark, CEO of the Company commented:

“This agreement is a landmark transaction for Destiny Pharma, as Sebela Pharmaceuticals is not only planning to finance all future clinical development and commercialisation costs of NTCD-M3 in the US, but also pay success based development and commercialisation milestone payments, as well double-digit royalties. The agreement could be worth up to a maximum of US$570m plus royalty income, which represents a tremendous potential return on investment in a little over two years since acquisition. We not only retain the majority of worldwide rights to NTCD-M3 outside the US, but also have a portfolio of other very valuable, novel drugs candidates in our portfolio, including our XF-73 Nasal gel, which has  completed a positive Phase 2b clinical trial and is heading towards the final Phase 3 clinical studies. This fundraising will put us in a robust position to continue to work on developing and commercialising these assets.

“We are grateful for the continued support of existing shareholders and are delighted to welcome a large number of new shareholders onto our register in what was an upsized and oversubscribed Placing.   We look forward to a year of further progress and now have an excellent partner in Sebela and a strong balance sheet to complete the development of NTCD-M3, which has a substantial market opportunity and the potential to add significant value to the Company.”

finnCap Limited (“finnCap”) and Shore Capital Stockbrokers Limited (“Shore Capital”) acted as Joint Bookrunners in connection with the Placing.

The Company intends to publish and send a shareholder circular and notice of General Meeting (the “Circular”) to Shareholders in connection with the Resolutions and the Open Offer on 28 February 2023. 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 (0)1273 704 440
pressoffice@destinypharma.com 

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

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

Optimum Strategic Communications
Mary Clark / Nick Bastin / Jonathan Edwards / Eleanor Cooper
+44 (0) 7931 500066
DestinyPharma@optimumcomms.com 

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

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

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has 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 drug 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.  Please click here for full press release Issue of Equity

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

Exclusive collaboration and co-development agreement for NTCD-M3 with Sebela Pharmaceuticals® worth up to $570m plus royalties

Partnership with Sebela will finance the future clinical development and commercialization costs of NTCD-M3 in North America

Destiny Pharma retains majority rights for Europe and ROW

Key strategic target achieved for NTCD-M3

Brighton, United Kingdom – 24 February 2023 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, is pleased to announce that it has signed an exclusive collaboration and co-development  agreement for the North American (U.S., Canada and Mexico) rights of NTCD-M3, its lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence, with Sebela Pharmaceuticals®, a U.S. pharmaceutical company with a market-leading position in gastroenterology.

Under the terms of the deal, it is anticipated that Sebela will lead and finance the future clinical development and commercialisation activities of NTCD-M3 in North America. The Company retains the majority of rights for Europe and Rest of the World and Sebela has a minority interest in any income generated in these non-North American territories based on the clinical studies it is funding.

The agreement, which could be worth up to $570m to Destiny Pharma in milestones alone, includes;

·    an initial upfront payment of $1m;
·    success-based development milestones of $19m;
·    sales revenues-based milestone payments up to $550m; and
·    tiered, double-digit royalties.

Destiny Pharma has the obligation to continue its current plan to complete the ongoing manufacture of all clinical trial supplies needed to undertake the required clinical studies. It is anticipated that Phase 3 studies will commence in 2024.

About NTCD-M3

NTCD-M3 was originally in-licensed by Destiny Pharma in November 2020 and is a naturally occurring non-toxigenic strain of C. difficile which lacks the genes that can express C. difficile toxins. It is an oral formulation of NTCD-M3 spores and patients who have taken NTCD-M3 were found to be protected from toxic strains of CDI. NTCD-M3 acts as a safe “ground cover” preventing toxic strains of C. difficile proliferating in the colon after antibiotic treatment. NTCD-M3 temporarily colonises the human gut without causing any symptoms and the gut microbiome returns to normal a few weeks after treatment.

About C. difficile

C. difficile is one of the leading causes of hospital acquired infection in the U.S. and poor treatments from antibiotics lead to cycles of repeated recurrence in many patients. In the U.S., there are approximately 500,000 cases of CDI each year; 25% of these initial cases then recur and there are approximately 29,000 deaths per year. Current CDI treatment options are limited, with lower efficacy observed when patients are retreated with the same antibiotic for recurrence of CDI.

About Sebela Pharmaceuticals®

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women’s health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialised a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development, including Tegoprazan, a novel potassium-competitive acid-blocker (P-CAB), in phase 3 trials in the US for the treatment of erosive esophagitis and non-erosive reflux disease. In addition, Sebela Women’s Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 340 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information.

Commenting on the announcement, Neil Clark, Chief Executive Officer of Destiny Pharma, said:

“We are very pleased to have reached this agreement with Sebela, a high quality, GI specialist company which has the necessary clinical development and commercialisation expertise to take NTCD-M3 through to launch. Such partnering deals are in line with our stated strategy of finding pharma partners to undertake the required Phase 3 clinical studies of our lead assets thus reducing the funding requirements of the Company.

“This deal is not only great news for the many thousands of patients that suffer from C. difficile infections each year but is also a tremendous endorsement of Destiny Pharma’s approach. In a little over two years since acquisition, we have managed to re-activate NTCD-M3 as a very exciting and valuable clinical candidate and find a commercialisation partner in Sebela with the capabilities to implement and fund all further clinical development costs as well as funding NTCD-M3’s launch and commercialisation in the key U.S. market. Destiny retains control over the rights for Europe and the Rest of the World (excluding China region), which we believe, together with our XF-73 programs, contain significant value potential.”

Commenting on the announcement, Alan Cooke, President and Chief Executive Officer of Sebela Pharmaceuticals said:

“We are delighted to partner with Destiny Pharma to advance NTCD-M3 to Phase 3 and plan for commercialization in the U.S. NTCD-M3 provides a unique and differentiated approach to prevent the recurrence of C. difficile infection and represents a significant addition to our valuable development pipeline.”

Investor Meet Presentation

DESTINY PHARMA PLC is pleased to announce that Neil Clark and Shaun Claydon will provide a live presentation via the Investor Meet Company platform on 27th Feb 2023 at 10.00am GMT.

The presentation is open to all existing and potential 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.

For further information, please contact:

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

Optimum Strategic Communications 
Mary Clark / Nick Bastin / Jonathan Edwards / Eleanor Cooper
+44 (0) 7931 5000 66
DestinyPharma@optimumcomms.com

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

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

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

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

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

About Destiny Pharma

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

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

Forward looking statements

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

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

US Center for Disease Control (CDC) and two major medical journals cite the importance of decolonization in preventing surgical site infections

Brighton, United Kingdom – 25 January 2023 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life-threatening infections, notes an increased focus on the importance of infection prevention by the Center for Disease Control (“CDC”), Food and Drug Administration (“FDA”), and the medical community in general, following a series of announcements and two publications in leading medical journals in recent weeks.

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

Dr. Yuri Martina, Chief Medical Officer of Destiny Pharma, said: “The Centre for Disease Control’s announcement clearly recognizes the need for new and effective decolonization agents and their importance for public health. They have made a clear call to simplify the pathway to regulatory approval and suggested the need for establishing new surrogate endpoints. Destiny Pharma views this as a very encouraging shift in the agency’s thinking that could be very supportive to our clinical  development of XF-73 Nasal.

“Furthermore, it is important to note the two new papers in such respected journals as the Journal of the American Medical Association and the New England Journal of Medicine, which have both underlined the importance of decolonization in preventing post-surgical infections and complications. Both papers have also elaborated on the substantial impact of post-surgical infections for patients and the potential for long-term debilitation and life-threatening consequences. At Destiny Pharma, we are committed to progressing the Phase 3 clinical development of our XF-73 Nasal gel targeting nasal decolonization and delivering a new product to prevent post-surgical infections and the resulting complications for patients in hospitals around the world.”

CDC announcement underlines the need for new decolonization agents

On 28th December 2022, the CDC released a Broad Agency Announcement, following up on a CDC-FDA workshop held in August 2022, that clearly underlines the need for new decolonization agents, which have largely been missing in recent years, leading to an important gap in the public health portfolio of infection prevention. The Company believes this adds further support to its Phase 3 clinical strategy for XF-73 Nasal gel targeting nasal decolonization prior to surgery and indicates that regulators are increasingly aware of the importance and value of decolonization to help prevent infections. Prevention is better than cure.

Two major review publications supporting decolonization published

In January 2023, two important review papers on the key role of decolonization were published, by The Journal of the American Medical Association (“JAMA”) and The New England Journal of Medicine (“NEJM”).

The Journal of the American Medical Association

The JAMA review was authored by Dr. Deverick J. Anderson and colleagues at Duke Center for Antimicrobial Stewardship and Infection Prevention of the Duke University School of Medicine. In this review, the authors underline the following key points:

• A large number of patients experience post-surgical infections, often with severe morbidity and complications.
• Surgical site infections are among the most prevalent health care-acquired infections and result in significant costs, potentially reaching US$10 billion per year.
• Approximately 70-95% of surgical sites infections are caused by the patient’s endogenous flora. Among these, S. aureus is the most common cause of infection.
• Several risk factors are associated with surgical site infection. Some can be modified, but others cannot be impacted.
• Nasal decolonization has shown a substantial reduction in surgical site infections and especially in high-risk surgeries like orthopaedic and cardiothoracic procedures.
• Nasal decolonization should be achieved as close to surgery as possible, as this is the time when it is most effective.
• The current standard of care requires a fairly long procedure and consequently a significant amount of coordination.

The New England Journal of Medicine

The NEJM review was authored by Dr. Robin Patel from the Division of Clinical Microbiology, Department of Medicine at the Mayo Clinic, and focuses on the topic of periprosthetic joint infection (PJI). In this paper, Dr. Patel discusses the importance of prevention to reduce the burden of PJI and its impact on the healthcare system and the patients. Importantly, Dr. Patel underlines the following critical points:

• PJI is a serious complication of orthopaedic surgery with an average frequency of 2.3%.
• PJI complication is costly and burdensome for the patient and the healthcare system. The author estimates additional cost of US$391,000 for a PJI of the hip.
• PJI is associated with extended hospital stay, less-than-ideal success rates, decreased quality of life, pain, and high mortality.
• Reducing risks factors is not always possible and some risk factors cannot be influenced.
• A major impact on reducing PJI incidence can be achieved by implementing proper decolonization protocols.

For further information, please contact:

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

Optimum Strategic Communications 
Mary Clark / Nick Bastin / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com

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

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

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

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

About Destiny Pharma

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

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

Notes to editors

• On 28^th December 2022, CDC released a Broad Agency Announcement calling for alternative clinical outcomes and/or surrogate endpoints to facilitate clinical trials for decolonization drugs
• On the 17^th of January 2023, a paper published in The Journal of American Medical Association (JAMA) underlines the importance of decolonization and nasal decolonization from S. aureus to prevent post-surgical site infection
• On the 19^th of January 2023, the New England Medical Journal (NEJM) published a paper discussing the issue of periprosthetic joint infection (PJI), its outcomes and implications and its prevention through the reduction of risk factors and proper decolonization protocols

Forward looking statements

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

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