02:00 Thu 09 Sep 2021
Destiny Pharma PLC - Interim results for six months ended 30 June 2021
Destiny Pharma plc
("Destiny Pharma" or the "Company")
Interim results for the six months ended
Primary endpoint met in XF-73 Phase 2b clinical trial
Secondary endpoint analysis showed XF-73 exhibited a significant and
sustained nasal reduction of S. aureus
Discussions progressing on XF-73 nasal Phase 3 study design
Good progress for NTCD-M3 programme targeting C. difficile infection recurrence: Phase 3 on track to start in H2 2022
Positive market research report underlines market opportunity for NTCD-M3 in US and
Company funded through to Q4 2022
Financial highlights
· Cash and term deposits at
· Net assets of
· Expenditure on R&D in the period of
· Company funded through to Q4 2022.
Operational highlights
XF-73 nasal gel for prevention of post-surgical infections
· Positive top-line results reported in
· Very good secondary endpoint data announced in
· Ongoing discussions with regulators regarding possible Phase 3 clinical trial designs. Detailed submission for scientific advice made to CHMP (Committee for Medicinal Products for Human Use at European Medicines Agency) in
· 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
·
NTCD-M3 for the prevention of C. difficile infection (CDI) recurrence
· Good progress being made with transfer and scale up of NTCD-M3 manufacturing process.
· Detailed planning for the single Phase 3 clinical study underway.
· Establishment of a NTCD-M3 clinical advisory board consisting of Professor
· Very strong support for NTCD-M3 TPP (Target Product Profile) from independent US and EU market research report received in
· Encouraging interest from potential licensing partners.
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 C. difficile infections.
· XF research projects with
· SporCov collaboration with SporeGen progressing well and on plan to complete around the year-end.
"Destiny Pharma has made exceptional progress in 2021. Our pipeline is focused and strong, with two exciting late-stage assets moving towards Phase 3 trials from two different technologies both targeting infection prevention.
We are very pleased with the quality of the XF-73 nasal Phase 2b data and are now focused on clarifying the Phase 3 trial designs in the US and
Our most advanced clinical programme is NTCD-M3 for the prevention of Clostridioides difficile infection (CDI) recurrence. As we finalise the Phase 3 study design and network with CDI medical experts, we are increasingly enthused by the positioning of NTCD-M3 as a single strain, natural biotherapeutic and its great potential in a large market where peak global product sales could reach
We diversified our risk profile in the last 12 months by adding two microbiome assets to our home grown XF platform. Our pipeline has depth, and our earlier XF programmes and our SporCov COVID-19 research project are all progressing well. We also continue to attract collaborations and grant/non-dilutive support from expert partners.
COVID-19 has highlighted vividly the healthcare impact of infectious diseases and we remain convinced that Destiny Pharma's unique pipeline has the potential to deliver novel, commercially attractive products to prevent life threatening infections."
For further information, please contact:
Destiny Pharma plc
+44 (0)1273 704 440
Optimum Strategic Communications
Mary Clark /
+44 (0) 208 078 4357
DestinyPharma@optimumcomms.com
finnCap Ltd (Nominated Adviser and Joint Broker)
+44 (0)20 7220 0500
WG Partners (Joint Broker)
+44 (0)20 3705 9321
MC Services AG
+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 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
Forward looking statements
Certain information contained in this announcement, including any information as to the Company'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 Company's results of operations, financial condition, prospects, growth, strategies and the industries in which the Company 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 Company's control. Forward looking statements are not guarantees of future performance. Even if the Company's actual results of operations, financial condition and the development of the industries in which the Company 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.
Chief Executive Officer's Statement
Operational review summary
Operational review
Destiny Pharma is a clinical stage biotechnology company dedicated to the development of novel medicines with a focus on infection prevention. The Company is developing novel antimicrobial drugs from its proprietary XF platform and also from two biotherapeutic products that harness beneficial components of the human microbiome. Destiny Pharma now has two exciting late-stage Phase 3 ready clinical assets, with large addressable markets, that have both reported strong Phase 2 data and a range of earlier research programmes.
XF-73 nasal, the Company's novel Phase 2b clinical asset from its proprietary XF platform, being developed for the prevention of post-surgical staphylococcal infections, reported positive top-line data in Q1 2021.
Destiny Pharma also has global rights to NTCD-M3 for the prevention of recurring Clostridioides difficile gut infections that is planned to start its Phase 3 study in H2 2022.
Destiny Pharma is also collaborating with SporeGen Limited on a novel treatment for the prevention of COVID-19 and similar respiratory viral infections using a Bacillus based approach. This project is at the preclinical development stage as are several earlier XF projects that are largely funded by grants/non-dilutive funding.
XF-73 nasal gel - Phase 2b clinical trial reported positive results in
There is a global need for better treatments to reduce post-surgical infections such as Destiny Pharma's XF-73 nasal gel, which has been awarded Qualifying Infectious Disease Product (QIDP) and Fast Track status by the US Food and Drug Administration (FDA). The recent clinical study tested the XF-73 nasal gel as a new investigational product for the prevention of the incidence of post-surgical infections caused by Staphylococcus aureus (S. aureus) such as methicillin-resistant S. aureus (MRSA). The primary efficacy endpoint was met with an exceptionally high statistical significance and there were no treatment related safety events.
Clinical Study Results Highlights
1. Met primary endpoint: XF-73 reduced the mean nasal burden of S. aureus in patients undergoing open heart surgery by 2.5 log (CFU/ml) in the 24 hours immediately before surgery in the micro-ITT (microbiological Intend to Treat) population, a statistically highly significant result, (p<0.0001). This equates to a 99.5% reduction in S. aureus bacterial nasal carriage which is a very effective reduction by accepted clinical measures.
2. XF-73 showed 2.1 log, (>99%), greater reduction than placebo in the same patient population and this difference in reduction of nasal burden of S. aureus was statistically highly significant (p<0.0001) in both the micro-ITT and per protocol populations. The effect was maintained during surgery, considered the period when the risk for infections is the highest. These positive results were achieved with just four doses of 0.2% (w/w) XF-73 nasal gel in the 24 hours before incision and the start of surgery.
3. The secondary endpoint analysis reported in
4. This sustained nasal microbiological effect in the period of greatest risk (pre-surgery to wound healing) of XF-73 in patients is a desirable attribute for the reduction in the risk of acquiring a post-surgical, staphylococcal infection. The secondary data demonstrates that XF-73 nasal gel has the potential to keep patients at a significantly low S. aureus nasal 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.
An abstract providing analysis and discussion of the late-breaking data arising from the recently completed Phase 2b clinical study of XF-73 nasal gel was accepted for presentation at
Destiny Pharma now plans to discuss Phase 3 clinical study designs with regulatory bodies including the US FDA and CHMP in
XF-73 is administered topically as a nasal gel whereby it reduces the nasal carriage of the bacteria S. aureus which is the source of many post-surgical bacterial infections. Approximately a third of all patients across the world have this nasal carriage as they enter surgery and it has the potential to be a very valuable market due to the millions of surgical procedures carried out each year.
The Company believes XF-73 is clearly differentiated from traditional antibiotics and many current anti-infective drugs in development due to the XF approach being prophylactic, following the well-established medical truth that "prevention is better than cure". The XF's target product profile also addresses the key issue of Antimicrobial Resistance (AMR). This is supported by feedback from our market research targeting physicians, pharmacists and payers in the US who are responsible for managing hospital infections and the associated cost implications. This research also supports our proposed pricing strategies for XF-73 nasal gel as a new hospital product and the Company estimates that there is a
NTCD-M3 for the prevention of C. difficile infection (CDI) recurrence
Destiny Pharma has global rights to NTCD-M3, 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 in trials to be well protected from CDI recurrence because NTCD-M3 acts as a safe "ground cover" preventing toxic strains of C. difficile proliferating in the colon after antibiotic treatment. NTCD-M3 temporarily colonizes the human gut without causing any symptoms and the gut microbiome returns to normal a few weeks after treatment.
NTCD-M3 has already completed a randomised, double-blind, placebo-controlled Phase 2b clinical study in 173 patients, who were diagnosed as having CDI (first episode or first recurrence) and reported strong, statistically significant data confirming efficacy. The rate of recurrence (RR) of CDI after treatment with the optimal dose of NTCD-M3 was only 5%, compared to 30% CDI recurrence for those receiving a placebo (JAMA 2015;313:1719). The rapid onset of colonisation of NTCD-M3 provides 95% protection from CDI recurrence during the post-treatment period, which makes it an ideal complement to all currently approved antibiotic treatments.
Destiny Pharma is making good progress in completing the tech transfer and scaling up processes for manufacturing of NTCD-M3 with the intention of starting a single Phase 3 clinical trial in H2 2022. The US FDA has previously agreed the outline Phase 3 design of a single, randomized, double-blind, placebo-controlled clinical study, with agreed endpoints, target CDI patient population and NTCD-M3 oral dosing regimen requiring 800 patients.
C. difficile is the leading cause of hospital acquired infection in the US and poor treatments lead to recurrence. In the US, there are approximately 500,000 cases of CDI each year; 25% of these initial cases then recur leading to 29,000 deaths per year. Current CDI treatment options are limited, with lower efficacy observed when patients are retreated with the same antibiotic for recurrence of CDI. Clinical data for NTCD-M3 appears superior to current treatments and drugs in development for the treatment of the recurrence of C. difficile infection.
The Company recently received a detailed market analysis report undertaken by independent experts who undertook a review by interviewing infectious disease experts in the CDI field to add to our understanding of the clinical, competitor and market access landscape in CDI for NTCD-M3. The feedback in both
In
XF-73 dermal - US NIAID support for next preclinical studies
Destiny Pharma's second most advanced programme with XF-73 is targeting the prevention and treatment of serious infections associated with wounds and ulcers such as diabetic foot ulcers (DFUs). This programme has previously demonstrated positive results across a range of preclinical efficacy studies and two Phase 1 dermal irritancy trials.
In
The Company is undertaking this work as part of its plan to develop XF-73 as a new treatment for DFU infections. Driven by the growing number of diabetics and their associated ulcer infections this represents a significant market opportunity for XF-73. As with all anti-infectives, AMR is also a concern within this market. There is no dominant treatment for DFUs, and specialist physicians are very interested in developing better treatment options including new topical product formulations.
Research update
The Company's earlier XF pipeline is largely funded through non-dilutive grant funding. These projects are looking at the utility of XF compounds to prevent and/or treat infections in ocular, respiratory, dermal and oral indications. Progress on these projects had been slowed due to COVID-19 and the associated restrictions on university based laboratory work but activity has increased this year.
The SporCov research project continues to proceed to plan with work continuing in the planned toxicology, influenza and COVID-19 pre-clinical models. The work is part funded by an
As noted above two new funded collaborations were started in 2021 in the XF-73 dermal programme and also with NTCD-M3. In both cases the US based collaborators are experts and are working with Destiny Pharma programmes as they believe in the scientific and clinical rationale and the potential of the assets to deliver new medicines.
Outlook
Destiny Pharma is in the unique position of having two, high quality, late-stage clinical assets targeting infection prevention. They are both supported by strong Phase 2 clinical data and address clear clinical needs where there are also significant commercial opportunities and the Board is committed to taking these late-stage programmes through to their final Phase 3 clinical studies.
The Company's strategy is to remain a research and development specialist and we therefore seek partners to lead the eventual commercialisation of these assets and help fund the Phase 3 clinical trials as well as exploring alternative funding options.
There is increased international support for the development of novel anti-infective drugs that address the issue of anti-microbial resistance and Destiny Pharma's unique platform is very well-positioned to meet this global need. The significant healthcare and economic impact of COVID-19 has clearly highlighted the global need for innovation that delivers fast, safe and affordable anti-infection treatments.
Chief Executive Officer
Condensed Statement of Comprehensive Income
For the 6 months ended
|
6 months ended Unaudited £ |
6 months ended Unaudited £ |
Year ended Audited £ |
Continuing operations |
|
|
|
Administrative expenses |
(2,898,724) |
(2,912,801) |
(6,425,471) |
Other operating income |
122,555 |
12,450 |
12,450 |
Share option charge |
(210,549) |
(58,668) |
(139,491) |
Operating loss |
(2,986,718) |
(2,959,019) |
(6,552,512) |
Finance income |
8,905 |
13,470 |
71,611 |
Loss before tax |
(2,977,813) |
(2,945,549) |
(6,480,901) |
Income Tax |
489,235 |
515,378 |
1,069,824 |
Loss and total comprehensive loss from continuing operations |
(2,488,578) |
(2,430,171) |
(5,411,077) |
|
|
|
|
Loss per share (Note 5) |
|
|
|
Basic and diluted |
(4.2)p |
(5.5)p |
(12.0)p |
Condensed Statement of Financial Position
For the 6 months ended
|
As at Unaudited £ |
As at Unaudited £ |
As at Audited £ |
ASSETS |
|
|
|
Non-current assets |
|
|
|
Property, plant and equipment (Note 6) |
39,886 |
25,764 |
18,141 |
Intangible assets (Note 7) |
2,261,435 |
- |
2,261,435 |
Non-current assets |
2,301,321 |
25,764 |
2,279,576 |
|
|
|
|
Current assets |
|
|
|
Trade and other receivables |
546,768 |
559,747 |
1,172,403 |
Prepayments and accrued income |
607,870 |
48,192 |
508,363 |
Cash and cash equivalents |
7,058,284 |
5,571,631 |
9,744,217 |
Current assets |
8,212,922 |
6,179,570 |
11,424,983 |
TOTAL ASSETS |
10,514,243) |
6,205,334) |
13,704,559) |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
Current liabilities |
|
|
|
Trade and other payables |
349,437 |
817,512 |
1,268,134 |
Current liabilities |
349,437 |
817,512 |
1,268,134 |
|
|
|
|
Shareholders' equity |
|
|
|
Issued share capital (Note 8) |
598,619 |
438,652 |
598,169 |
Share premium |
27,091,466 |
17,296,337 |
27,085,506 |
Accumulated losses |
(17,525,279) |
(12,347,167) |
(15,247,250) |
Total shareholders' equity |
10,164,806 |
5,387,822 |
12,436,425 |
TOTAL EQUITY AND LIABILITIES |
10,514,243) |
6,205,334) |
13,704,559) |
Condensed Statement of Changes in Equity
For the 6 months ended
|
Issued share capital £ |
Share premium £ |
Accumulated £ |
Total £ |
As at |
598,169 |
27,085,506 |
(15,247,250) |
12,436,425 |
Loss and total comprehensive loss for the period |
- |
- |
(2,488,578) |
(2,488,578) |
Issue of share capital |
450 |
5,960 |
- |
6,410 |
Share based payment expense |
- |
- |
210,549 |
210,549 |
As at |
598,619) |
27,091,466) |
(17,525,279) |
10,164,806) |
|
Issued share capital £ |
Share premium £ |
Accumulated £ |
Total £ |
As at |
438,652 |
17,296,337 |
(9,975,664) |
7,759,325 |
Total comprehensive loss and loss for the period |
- |
- |
(2,430,171)
|
(2,430,171) |
Share based payment expense |
- |
- |
58,668 |
58,668 |
As at |
438,652) |
17,296,337) |
(12,347,167) |
5,387,822) |
|
Issued share capital £ |
Share premium £ |
Accumulated £ |
Total £ |
As at |
438,652 |
17,296,337 |
(9,975,664) |
7,759,325 |
Loss and total comprehensive loss for the period |
|
- |
(5,411,077)
|
(5,411,077) |
Issue of share capital |
159,517 |
10,209,105 |
- |
10,368,622 |
Costs of share issue |
- |
(419,936) |
- |
(419,936) |
Share based payment expense |
- |
- |
139,491 |
139,491 |
As at |
598,169) |
27,085,506) |
(15,247,250) |
12,436,425) |
Condensed Statement of Cash Flows
For the 6 months ended
|
6 months ended Unaudited £ |
6 months ended Unaudited £ |
Year ended Audited £ |
Cash flows from operating activities |
|
|
|
Loss before income tax |
(2,977,813) |
(2,945,549) |
(6,480,901) |
Depreciation charges |
5,996 |
9,017 |
16,881 |
Share based payment expense |
210,549 |
58,668 |
139,491 |
Finance income |
(8,905) |
(13,470) |
(71,611) |
Decrease/(increase) in trade and other receivables and prepayments |
|
|
|
Increase/(decrease) in trade and other payables |
|
|
|
Tax received |
1,069,824 |
839,079 |
813,250 |
Net cash used in operating activities |
(2,673,506) |
(1,919,622) |
(5,492,188) |
|
|
|
|
Cash flows from investing activities |
|
|
|
Purchase of tangible fixed assets |
(27,742) |
(1,859) |
(2,099) |
Purchase of intangible fixed assets |
- |
- |
(2,261,435) |
Interest received |
8,905 |
13,470 |
71,611 |
Net cash flow from investing activities |
(18,837) |
11,611 |
(2,191,923) |
|
|
|
|
Cash flows from financing activities |
|
|
|
New shares issued net of issue costs |
6,410 |
- |
9,948,686 |
Net cash inflow from financing activities |
6,410 |
- |
9,948,686 |
|
|
|
|
Net decrease in cash and cash equivalents |
(2,685,933) |
(1,908,011) |
2,264,575 |
Cash and cash equivalents at the beginning of the period |
|
|
|
Cash and cash equivalents at the end of the period |
|
|
|
Notes to the Condensed Financial Statements
1. General Information
Destiny Pharma plc ("Destiny", or the "Company") was incorporated and domiciled in the UK on
Destiny is engaged in the discovery, development and commercialisation of new antimicrobials that have unique properties to improve outcomes for patients and the delivery of medical care into the future.
2. Basis of Preparation
These interim unaudited financial statements have been prepared in accordance with AIM Rule 18, 'Half yearly reports and accounts'. The financial information contained in these interim financial statements have been prepared under the historical cost convention and on a going concern basis.
The interim financial information for the six months ended
In the opinion of the Directors, the interim financial information presents fairly the financial position, and results from operations and cash flows for the period. Comparative amounts for the six months ended
The interim financial statements for the six months ended
3. Accounting Policies
The unaudited interim financial statements for the period have been prepared on the basis of the accounting policies adopted in the audited report and accounts of the Company for the year ended
4. Segmental Information
The chief operating decision-maker is considered to be the Board of Directors of Destiny Pharma. The chief operating decision-maker allocates resources and assesses performance of the business and other activities at the operating segment level.
The chief operating decision maker has determined that Destiny Pharma has one operating segment, the discovery, development and commercialisation of pharmaceutical formulations.
Geographical Segments
The Company's only geographical segment during the period was the UK.
5. Loss Per Share
The calculation for loss per ordinary share (basic and diluted) for the relevant period is based on the earnings after income tax attributable to equity shareholders for the period. As the Company made losses during the period, there are no dilutive potential ordinary shares in issue, and therefore basic and diluted loss per share are identical. The calculation is as follows:
|
6 months ended Unaudited £ |
6 months ended Unaudited £ |
Year ended Audited £
|
Loss for the period from continuing operations |
|
|
|
|
|
|
|
Weighted average number of shares |
59,840,623 |
43,865,195 |
45,219,999 |
|
|
|
|
Loss per share - pence |
|
|
|
Basic and diluted |
(4.2)p |
(5.5)p |
(12.0)p |
6. Property, plant and equipment
|
Plant and machinery |
|
£ |
Cost |
|
At |
120,188 |
Additions |
27,742 |
At |
147,930 |
|
|
Depreciation |
|
At |
102,048 |
Charge for the period |
5,996 |
At |
108,044 |
|
|
Net book value at |
39,886 |
|
Plant and machinery |
|
£ |
Cost |
|
At |
118,089 |
Additions |
1,859 |
At |
119,948 |
|
|
Depreciation |
|
At |
85,167 |
Charge for the period |
9,017 |
At |
94,184 |
|
|
Net book value at |
25,764 |
|
|
|
|
Property, plant and equipment (contd.)
|
Plant and machinery |
|
£ |
Cost |
|
At |
118,089 |
Additions |
2,099 |
At |
120,188 |
|
|
Depreciation |
|
At |
85,167 |
Charge for the year |
16,881 |
At |
102,048 |
|
|
Net book value at |
18,141 |
7. Intangible assets
|
Acquired development programmes |
|
£ |
Cost |
|
At |
2,261,435 |
Additions |
- |
Cost and Net book value at |
2,261,435 |
Cost |
|
At |
- |
Additions |
- |
Cost and Net book value at |
- |
Cost |
|
At |
- |
Additions |
2,261,435 |
Cost and Net book value at |
2,261,435 |
8. Share capital
On
On
9. Events after the end of the reporting period
There are no events subsequent to the reporting period that require adjustment or disclosure.
10. Copies of the interim financial statements
Copies of these interim unaudited financial statements are available on the Company's website at www.destinypharma.com and from the Company's registered office, Unit
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