REG - Destiny Pharma PLC - Interim results for six months ended 30 June 2022
08/09/2022 07:01
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RNS Number : 6817Y Destiny Pharma PLC 08 September 2022
Destiny Pharma plc
("Destiny Pharma" or the "Company")
Interim results for the six months ended 30 June 2022
Received positive feedback from EMA on Phase 3 plans for NTCD-M3
Received positive scientific advice from FDA and EMA on XF-73 Nasal Phase 3
plans
New XF research projects initiated in cystic fibrosis and oral mucositis
Strengthened leadership with appointment of Chief Medical Officer and two
Non-Executive Directors
Raised gross proceeds of £6.45 million through Q1 fundraising
extending cash runway through mid-2023
Brighton, United Kingdom - 08 September 2022 - Destiny Pharma (AIM: DEST), a
clinical stage biotechnology company focused on the development of novel
products to prevent life threatening infections, announces its unaudited
interim financial results for the half-year ended 30 June 2022 and provides an
update for the year to date.
Financial highlights
· Cash and short term deposits at 30 June 2022 of £8.4 million
(30 June 2021: £7.1 million; 31 December 2021: £4.6 million).
· Net assets of £10.7 million at 30 June 2022 (30 June 2021:
£10.2 million; 31 December 2021: £7.5 million).
· Expenditure on R&D in the period of £2.5 million
(half-year 2021: £2.0 million; full year 2021: £3.7 million).
· Company funded through to mid-2023.
Operational highlights
NTCD-M3 for the prevention of C. difficile infection (CDI) recurrence
· Finalising preparations for the pivotal Phase 3 clinical trial
of NTCD-M3 and good progress made on partner discussions to help co-fund
studies and lead commercialisation.
· Positive scientific advice received from European Medicines Agency
(EMA) on proposed Phase 3 study design.
· US and European market research confirms substantial market
opportunity for NTCD-M3.
· Results from US research support the use of NTCD-M3 following
all commonly used antibiotic treatments.
· Positive new data published on the absence of toxic gene transfer
to NTCD-M3 in the peer-reviewed journal, Public Library of Science One (PLOS
ONE).
XF-73 Nasal for the prevention of post-surgical infections
· US Food and Drug Administration (FDA) has clarified Phase 3 and US
registration pathway for XF-73 Nasal gel for the prevention of post-surgical
staphylococcal infections.
· EMA feedback on XF-73 Nasal gel Phase 3 programme identifies a
clear route through European approval as a ground-breaking hospital infection
prevention product.
· Global Phase 3 study design progressing following discussions with
regulators and key opinion leaders.
· External European market research reports 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. The study suggests XF-73 has the
potential to replace the current standard of treatment as the preferred
pre-surgical nasal decolonisation agent.
Earlier pipeline and research projects
· SPOR-COV, our collaboration with SporeGen to develop a novel nasal
spray to prevent viral respiratory infections, including COVID-19 and
influenza, is at an exciting stage having almost completed the grant funded
work.
· Positive results in XF-73 Dermal safety study from ongoing
agreement with US Government's NIAID.
· Destiny's China partner, China Medical System Holdings Ltd
(CMS), is conducting pre-clinical work on their own XF-73 Dermal programme.
· XF-73 shown to enhance the activity of two antibacterial drugs with
the potential to develop improved treatments for lethal lung infections and
infected diabetic foot ulcers caused by antimicrobial resistant bacteria.
· Secured funding from the Cystic Fibrosis Foundation for new XF
research project.
· Initiated new XF research project targeted at oral mucositis.
Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
"Destiny Pharma has two exciting, late-stage clinical assets moving towards
Phase 3 trials originating from two different technologies both targeting
infection prevention.
I am pleased with the progress made in the first half of 2022 in moving our
two lead clinical assets, NTCD-M3 and XF-73 Nasal, towards Phase 3 trials. We
have progressed partnering discussions in relation to NTCD-M3 and have
advanced our US and European regulatory plans for both programmes.
Additionally, Destiny Pharma also has a strong pre-clinical pipeline. We
remain convinced that our products, once commercialised, will reduce the
number of infections and improve outcomes for patients, and help reduce
significant healthcare costs while serving large global markets.
I am confident we will make further significant progress during the remainder
of 2022 and beyond with our clear focus on infection prevention and delivering
value to shareholders."
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0) 127 370 4440
pressoffice@destinypharma.com (mailto:pressoffice@destinypharma.com)
Optimum Strategic Communications
Mary Clark / Manel Mateus / Eleanor Cooper
+44 (0) 203 922 0891
DestinyPharma@optimumcomms.com (mailto:DestinyPharma@optimumcomms.com)
finnCap Ltd (Nominated Adviser and Joint Broker)
Geoff Nash / Abigail Kelly / 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
Stern IR - US
Janhavi Mohite
+1-212-362-1200
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 drug research projects.
For further information on the company, please visit www.destinypharma.com
(http://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
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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 from two biotherapeutic products that harness beneficial
components of the human microbiome. Destiny Pharma has two exciting late-stage
Phase 3 ready clinical assets, targeting large global markets, which have both
already reported strong Phase 2 data. The Company also has a portfolio of
earlier research programmes.
NTCD-M3 - preventing the recurrence of CDI
NTCD-M3 is being developed by Destiny Pharma as a simple oral capsule for the
prevention of recurring Clostridioides difficile gut infections (CDI).
Destiny Pharma holds global rights following the licensing of NTCD-M3 in 2020
and has invested in the project to successfully reactivate the clinical and
manufacturing programme. The Company is advancing partnering discussions to
co-fund the planned Phase 3 clinical studies and to lead commercialisation.
C. difficile affects subjects across the world and is the leading cause of
hospital acquired infection in the US where the current, relatively poor
treatments lead to high levels of CDI 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. It is estimated that CDIs result in
an additional US$6 billion in healthcare costs per year, in the US alone.
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 estimates that there is a US$1 billion peak global sales opportunity
for NTCD-M3.
NTCD-M3, 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. 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 colonises 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% for
patients receiving placebo (JAMA 2015;313:1719). The rapid colonisation onset
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 currently finalising preparations for the pivotal Phase 3
clinical trial of NTCD-M3. In the period under review, the Company has been
making good progress in scaling up manufacturing and regulatory discussions
with both the FDA and EMA. The US FDA has previously agreed the outline Phase
3 design of a single, randomised, double-blind, placebo-controlled clinical
study, with agreed endpoints, target CDI patient population and NTCD-M3 oral
dosing regimen requiring 800 patients.
Further support for the NTCD-M3 Target Product Profile has been reported from
two important research studies completed in 2022 at the US Department of
Veterans Affairs at the VA Hines Laboratories in the US. The first study,
carried out by Professor Dale Gerding and his team, examined in vitro the
potential for the transfer of the gene responsible for toxin production from a
toxigenic strain of C. difficile to NTCD-M3. Such a transfer would be
undesirable as it is the toxins produced that are responsible for causing
serious gut irritation and major life-threatening symptoms of this common
hospital gut infection.
Importantly, the study demonstrated that attempted conjugations using a
toxigenic C. difficile strain (630∆erm) as a gene donor, did not lead to
toxic gene transfer NTCD-M3. This finding for NTCD-M3 demonstrates the
inability for the transfer of the genes which encode for toxin production into
our novel biotherapeutic product. This provides additional evidence that such
transfer will not occur clinically and supports the Company's view that
NTCD-M3 will deliver an effective and safe treatment.
In the Phase 2 clinical trial that tested NTCD-M3 in patients suffering CDI
recurrence after the use of standard antibiotics to treat the initial
infection, either vancomycin or metronidazole were the antibiotics used to
treat the initial toxic C. difficile infection. Since the Phase 2 trial was
completed, a new antibiotic, fidaxomicin, has been added to US clinical
guidelines for treating CDI. It is known that fidaxomicin resides for a longer
period within the gut potentially inhibiting the colonisation by bacteria such
as NTCD-M3. The second NTCD-M3 research study reported in 2022 sought to
address this question by monitoring the colonisation of NTCD-M3 in an
established CDI model following administration of fidaxomicin.
In summary, this successful study 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.
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 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 ground-breaking
NTCD-M3 live biotherapeutics product can be used alongside all currently
recommended antibiotics in the treatment of this serious hospital infection.
North American and European market research has also been completed in 2022
to understand the commercial implications of the clinical and market access
landscape in CDI for NTCD-M3. Interviews were conducted with High-Volume
Prescribers (HVPs) and reimbursement experts across the US and Europe. The
findings provide powerful external validation for Destiny Pharma's product
NTCD-M3 from clinicians and payers in both the US and Europe.
Key findings from the market research included:
1. Physicians were very optimistic about NTCD-M3's potential given the
very low recurrence rate of 5% seen in the Phase 2 study, its mechanism of
action, and safety profile. NTCD-M3 has low cost of goods, long shelf life,
and if it can replicate the 5% recurrence rate in a Phase 3 study, would be
much more efficacious in preventing recurrence when compared to products in
development and on the market. A simple administration profile of one capsule
per day for 7 days to achieve colonisation was also seen as beneficial over
the competitors.
2. There is significant interest in using the product to prevent
recurrence after a primary episode (a first infection) and first recurrence
patients (those who have had a first infection and then subsequently a
recurrence). These are patient groups with significant medical need and where
it is necessary to disrupt the recurrence escalator early on before patients
get into a terrible cycle of cure and recurrence which leads to increased
morbidity and increased mortality.
3. Taking all the benefits together including cost and ease of use, the
clinicians could see significant benefit of NTCD-M3's approach over FMT
(Faecal Microbiota Transplant) or bacterial consortia products. Payers in both
the US and EU anticipate strong reimbursement potential given NTCD-M3's
profile and at a price to encourage uptake in the primary episode and first
recurrence patients. They could see the benefit of using the product early to
reduce the cycle of recurrence and in turn reduce the significant healthcare
burden managing this infection places on hospitals and healthcare systems.
The growing research, clinical and market data set we are building for NTCD-M3
combined with our interactions with key opinion leaders underpins our strong
belief that NTCD-M3 is a high-quality, late-stage clinical asset. We are
progressing partnering discussions on NTCD-M3 with the aim of completing a
deal to enable the Phase 3 clinical study to start in the second half of 2023,
when clinical trial drug supply will be available.
XF-73 Nasal - preventing post-surgical infections
XF-73 Nasal is the Company's lead clinical asset from its proprietary XF
platform, being developed for the prevention of post-surgical staphylococcal
infections.
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
FDA. One in three people are S. aureus carriers. Carriers have up to twelve
times higher risk of post-surgical infection.
EMA and FDA feedback in 2022 has clarified the routes to approval for the
programme and allowed progress to be made on the Phase 3 study design and
costings. The Company is exploring the possibility of designing a global Phase
3 clinical programme, likely to consist of two studies, which meets the
requirements of both the FDA and EMA.
Feedback from US Food and Drug Administration (FDA)
The key points of the FDA feedback were as follows:
1. The FDA agreed to the proposed Phase 3 design comparing XF-73 Nasal gel
to placebo on top of standard of care for the prevention of post-surgical
staphylococcal infections following certain breast surgery operations. This
type of surgery is being proposed as patients can experience a relatively high
infection rate following the current standard of care and there is a clear
unmet medical need.
2. The FDA is open to the collection of microbiological data during the
proposed Phase 3 study that could lead to the development of a surrogate
marker for clinical efficacy in other types of surgery.
3. Based on the favourable safety profile from the clinical development
programme so far, the FDA has confirmed that no specialised nasal examinations
are needed in the Phase 3 study. In line with the above, the FDA has also
removed the previous requirement to clinically evaluate skin sensitisation.
4. The regulatory feedback will enable Destiny Pharma to simplify the Phase
3 study design and is expected to shorten the overall clinical development
programme in the US.
Feedback from European Medicines Agency (EMA)
The key highlights of the EMA feedback were as follows:
1. 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.
2. Agreement that the patient population to enroll in the Phase 3 trials
will be those who are nasal carriers of S. 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 study.
3. 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.
4. Agreement with the proposed XF-73 nasal gel product pack approach for
Phase 3 and its commercial suitability for the European market.
In the US, EU and worldwide, there are no approved nasal decolonisation drugs
for the prevention of post-surgical staphylococcal infections. The generic
antibiotic mupirocin has been used to treat patients who carry the bacteria
prior to surgery to reduce the risk of infection. However, the use of existing
preventative treatments is severely limited by the existence, and fear of
generating drug resistant bacteria. In contrast, XF-73 Nasal gel has been
shown not to generate drug-resistant bacteria and thereby reduces the threat
posed by Anti-Microbial Resistance (AMR). Furthermore, this superior bacterial
resistance profile makes it ideally suited for widespread use in the
prevention of post-surgical infections. The Company estimates that there is a
US$1 billion peak sales opportunity in the US alone.
The Company is on track to clarify the Phase 3 clinical plan by year end and
will then aim to find a partner(s) to help fund the Phase 3 trials and
commercialise XF-73 Nasal gel with the Phase 3 studies starting in early 2024.
Pre-clinical pipeline update
While our main focus remains on our two lead clinical programmes, we have
sought to advance our earlier research projects that are largely funded by
external grants.
Destiny Pharma is working with the US National Institute of Allergy and
Infectious Diseases (NIAID) to develop XF-73 Dermal, focused on treating
serious infections associated with open wounds and broken skin including
diabetic foot ulcers. In February, we announced positive results from the
first of two preclinical safety studies. The study met its objectives and
generated positive data, which clears the path for its progression into the
second and final clinically‑enabling regulatory safety study. Both studies
are being conducted through NIAID's suite of preclinical services.
Destiny Pharma's China regional partner and investor, China Medical System
Holdings (CMS), established a new dermal programme in 2021 with XF-73
targeting the prevention and treatment of superficial skin infections caused
by bacteria. CMS is carrying out pre-clinical work which has produced
encouraging data.
SPOR-COV is a prophylactic approach targeting the innate immune system with
the potential to develop COVID-19 and influenza protection within a few days
of treatment. We are working with our partner SporeGen to establish the next
steps for this project and there is potential for SPOR-COV in the natural
product sector as well as the drug development/prescribed pharmaceutical
space.
In July 2022, Destiny Pharma announced it had received an award from the
Cystic Fibrosis Foundation. The research project will establish the potential
of XF-73 as a novel treatment for cystic fibrosis patients infected with
methicillin-resistant Staphylococcus aureus (MRSA). The project will have
access to clinical isolates collected from people with cystic fibrosis and the
work will be carried out by experienced researchers associated with the
Foundation.
Destiny Pharma started a new research project targeted at oral mucositis in
2022. We see potential in XF-73 as a preventive medicine to ease suffering
from oral mucositis, an inflammation of the mouth that is a common side effect
of chemotherapy and radiotherapy.
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 their final Phase 3
clinical studies.
The Company's strategy is to remain a research and development specialist and
is therefore seeking partners to lead the eventual commercialisation of these
assets and help fund the Phase 3 clinical trials as well as exploring
alternative funding options. We continue to make good progress in partnering
discussions for NTCD-M3 and are looking to finalise arrangements as soon as
possible.
There is increased international support for the development of novel
anti-infective drugs that address the issue of anti-microbial resistance,
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. We remain committed to meeting this
challenge, delivering new medicines and creating significant value for
shareholders.
Neil Clark
Chief Executive Officer
08 September 2022
Condensed Statement of Comprehensive Income
For the 6 months ended 30 June 2022
6 months ended 6 months ended Year ended
30 June 2022 30 June 2021 31 December 2021
Unaudited Unaudited Audited
£ £ £
Continuing operations
Administrative expenses (3,550,876) (2,898,724) (6,016,128)
Other operating income 12,967 122,555 135,028
Share option charge (275,854) (210,549) (405,851)
Operating loss (3,813,763) (2,986,718) (6,286,951)
Finance income 16,613 8,905 15,520
Loss before tax (3,797,150) (2,977,813) (6,271,431)
Income Tax 608,848 489,235 931,951
Loss and total comprehensive loss from continuing operations (3,188,302) (2,488,578) (5,339,480)
Loss per share (Note 5)
Basic and diluted (4.8)p (4.2)p (8.9)p
Condensed Statement of Financial Position
For the 6 months ended 30 June 2022
As at As at As at
30 June 2022 30 June 2021 31 December 2021
Unaudited Unaudited Audited
£ £ £
ASSETS
Non-current assets
Property, plant and equipment (Note 6) 29,521 39,886 35,882
Intangible assets (Note 7) 2,261,435 2,261,435 2,261,435
Non-current assets 2,290,956 2,301,321 2,297,317
Current assets
Trade and other receivables 720,673 546,768 991,913
Prepayments and accrued income 119,974 607,870 347,950
Cash and cash equivalents 8,371,047 7,058,284 4,645,562
Current assets 9,211,694 8,212,922 5,985,425
TOTAL ASSETS 11,502,650) 10,514,243) 8,282,742)
EQUITY AND LIABILITIES
Current liabilities
Trade and other payables 819,337 349,437 773,436
Current liabilities 819,337 349,437 773,436
Shareholders' equity
Issued share capital (Note 8) 733,071 598,619 598,719
Share premium 33,043,569 27,091,466 27,091,466
Accumulated losses (23,093,327) (17,525,279) (20,180,879)
Total shareholders' equity 10,683,313 10,164,806 7,509,306
TOTAL EQUITY AND LIABILITIES 11,502,650) 10,514,243) 8,282,742)
Condensed Statement of Changes in Equity
For the 6 months ended 30 June 2022
Issued share Share Accumulated
losses
capital premium
Total
£
£ £ £
As at 1 January 2022 598,719 27,091,466 (20,180,879) 7,509,306
Loss and total comprehensive loss
for the period - - (3,188,302) (3,188,302)
Issue of share capital 134,352 6,332,565 - 6,466,917
Costs of share issue - (380,462) - (380,462)
Share based payment expense - - 275,854 275,854
As at 30 June 2022 733,071) 33,043,569)) (23,093,327) 10,683,313)
Issued share Share Accumulated
losses
capital premium
Total
£
£ £ £
As at 1 January 2021 598,169 27,085,506 (15,247,250) 12,436,425
Total comprehensive loss and 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 30 June 2021 598,619) 27,091,466) (17,525,279) 10,164,806)
Issued share Share Accumulated
losses
capital premium
Total
£
£ £ £
As at 1 January 2021 598,169 27,085,506 (15,247,250) 12,436,425
Total comprehensive loss and loss
for the period - - (5,339,480) (5,339,480)
Issue of share capital 550 5,960 - 6,510
Share based payment expense - - 405,851 405,851
As at 31 December 2021 598,719) 27,091,466) (20,180,879) 7,509,306)
Condensed Statement of Cash Flows
For the 6 months ended 30 June 2022
6 months ended 30 June 2022 6 months ended Year ended
30 June 2021
Unaudited
31 December 2021
Unaudited
£
Audited
£
£
Cash flows from operating activities
Loss before income tax (3,797,150) (2,977,813) (6,271,431)
Depreciation charges 6,361 5,996 12,518
Share based payment expense 275,854 210,549 405,851
Finance income (16,613) (8,905) (15,520)
Decrease/(increase) in trade and other receivables and prepayments 180,808 (54,461) 198,336
Increase/(decrease) in trade and other payables 45,901 (918,696) (494,698)
Tax received 927,256 1,069,824 1,074,519
Net cash used in operating activities (2,377,583) (2,673,506) (5,090,425)
Cash flows from investing activities
Purchase of tangible fixed assets - (27,742) (30,260)
Interest received 16,613 8,905 15,520
Net cash flow from investing activities 16,613 (18,837) (14,740)
Cash flows from financing activities
New shares issued net of issue costs 6,086,455 6,410 6,510
Net cash inflow from financing activities 6,086,455 6,410 6,510
Net increase in cash and cash equivalents 3,725,485 (2,685,933) (5,098,655)
Cash and cash equivalents at the beginning of the period 4,645,562 9,744,217 9,744,217
Cash and cash equivalents at the end of the period 8,371,047) 7,058,284) 4,645,562)
Notes to the Condensed Financial Statements
1. General Information
Destiny Pharma plc ("Destiny" or the "Company") was incorporated and domiciled
in the UK on 4 March 1996 with registration number 03167025. Destiny's
registered office is located at Unit 36 Sussex Innovation Centre Science Park
Square, Falmer, Brighton, BN1 9SB.
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 30 June 2022, six
months ended 30 June 2021 and the year ended 31 December 2021 contained within
this interim report do not comprise statutory accounts within the meaning of
section 434 of the Companies Act 2006. The financial information for the
year ended 31 December 2021 is based on the statutory accounts for the year
ended 31 December 2021. Those accounts, upon which the auditors issued an
unqualified opinion, have been delivered to the Registrar of Companies and did
not contain statements under section 498(2) or (3) of the Companies Act 2006.
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 30 June 2021 are also
unaudited.
The interim financial statements for the six months ended 30 June 2022 were
approved by the Board on 07 September 2022.
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 31 December 2021 and expected to
be adopted in the financial year ending 31 December 2022.
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 30 June 2022 6 months ended 30 June 2021 Year ended
Unaudited Unaudited 31 December 2021
£ £ Audited
£
Loss for the period from continuing operations (3,188,302) (2,488,578) (5,339,480)
Weighted average number of shares 66,600,552 59,840,623 59,851,442
Loss per share - pence
Basic and diluted (4.8)p (4.2)p (8.9)p
6. Property, plant and equipment
Plant and machinery
£
Cost
At 1 January 2022 150,448
Additions -
At 30 June 2022 150,448
Depreciation
At 1 January 2022 114,566
Charge for the period 6,361
At 30 June 2022 120,927
Net book value at 30 June 2022 29,521
Plant and machinery
£
Cost
At 1 January 2021 120,188
Additions 27,742
At 30 June 2021 147,930
Depreciation
At 1 January 2021 102,048
Charge for the period 5,996
At 30 June 2021 108,044
Net book value at 30 June 2021 39,886
Property, plant and equipment (contd.)
Plant and machinery
£
Cost
At 1 January 2021 120,188
Additions 30,260
At 31 December 2021 150,448
Depreciation
At 1 January 2021 102,048
Charge for the year 12,518
At 31 December 2021 114,566
Net book value at 31 December 2021 35,882
7. Intangible assets
Acquired development programmes
£
Cost
At 1 January 2022 2,261,435
Additions -
Cost and Net book value at 30 June 2022 2,261,435
Cost
At 1 January 2021 2,261,435
Additions -
Cost and Net book value at 30 June 2021 2,261,435
Cost
At 1 January 2021 -
Additions 2,261,435
Cost and Net book value at 31 December 2021 2,261,435
8. Share capital
On 29 March 2022, 12,909,007 new Ordinary shares were issued following a
fundraise comprised of a placing, subscription and open offer. The Company
raised gross proceeds of £6.45m from the fundraise 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.
526,177 new Ordinary shares were issued in the half-year ended 30 June 2022
following the exercise of share options: On 04 February 2022, 466,177 new
shares were issued, on 07 February 2022, 30,000 new shares were issued and on
28 March, 30,000 new shares were issued.
On 24 January 2022, 54,282 Employee LTIP 2020 Options were granted to the
following employees: William Love 11,501, Shaun Claydon 11,725, Neil Clark
16,914 and Stephanie Bewick 14,142. These options have been granted at an
exercise price of £0.01 per ordinary share and will vest on the second
anniversary of the date of grant.
On 08 June 2022, 190,000 options were granted under the Destiny Pharma plc
2020 Long Term Incentive Plan to Yuri Martina. The options have been granted
at an exercise price of £0.46 and will vest on the third anniversary of the
date of grant.
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 36 Sussex Innovation Centre Science Park Square, Falmer,
Brighton, BN1 9SB.
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