TIDMDEST
RNS Number : 1793L
Destiny Pharma PLC
09 September 2021
Destiny Pharma plc
("Destiny Pharma" or the "Company")
Interim results for the six months ended 30 June 2021
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 Europe
Company funded through to Q4 2022
Brighton, United Kingdom - 9 September 2021 - Destiny Pharma
(AIM: DEST), a clinical stage, innovative biotechnology company
focused on the development of novel medicines to prevent life
threatening infections, announces its unaudited interim financial
results for the half-year ended 30 June 2021 and an update for the
year to date.
Financial highlights
-- Cash and term deposits at 30 June 2021 of GBP7.1 million (30
June 2020: GBP5.6 million; 31 December 2020: GBP9.7 million).
-- Net assets of GBP10.2 million at 30 June 2021 (30 June 2020:
GBP5.4 million; 31 December 2020: GBP12.4 million).
-- Expenditure on R&D in the period of GBP2.0 million
(half-year 2020: GBP2.3 million; full year 2020: GBP4.5
million).
-- Company funded through to Q4 2022.
Operational highlights
XF-73 nasal gel for prevention of post-surgical infections
-- Positive top-line results reported in March 2021. Primary
efficacy endpoint met successfully with exceptionally high
statistical significance and no treatment related safety
events.
-- Very good secondary endpoint data announced in August 2021
shows that XF-73 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.
-- 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 August 2021.
-- 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.
-- Brazil's Industrial Property Office has issued a notice of
allowance that will now lead to the final approval of the Company's
patent application (Brazilian Patent Application no. PI 0512563-4)
in relation to XF-73.
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 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.
-- Very strong support for NTCD-M3 TPP (Target Product Profile)
from independent US and EU market research report received in
August 2021. Feedback supports market positioning and pricing
strategies.
-- 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 Cardiff, Tianjin (China),
Sheffield, Southampton and Aston Universities making progress after
COVID-19 delays.
-- SporCov collaboration with SporeGen progressing well and on
plan to complete around the year-end.
Neil Clark, Chief Executive Officer of Destiny Pharma,
commented:
"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 Europe. We are confident that XF-73 has the potential to
deliver a major improvement in the prevention of post-surgical
infections caused by Staphylococcus aureus. There is a clear
clinical need and commercial opportunity for XF-73 in the hospital
setting which we estimate in the US alone to be peak annual product
sales of $1 billion.
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 $1 billion.
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
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
pressoffice@destinypharma.com
Optimum Strategic Communications
Mary Clark / Hollie Vile / Manel Mateus
+44 (0) 208 078 4357
DestinyPharma@optimumcomms.com
finnCap Ltd (Nominated Adviser and Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0)20 3705 9321
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 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 March 2021
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 August 2021
showed that XF-73 dosed patients can also benefit from a sustained
bacterial reduction at the three post-surgical sample time points
after wound closure of 1 hour, 2 and 6 days demonstrating 2.5 log,
2.4 log and 2.8 log reductions, respectively, and sustaining the
drop of over 99% in S. aureus nasal burden. The placebo treated
patients reported 0.4 log, 1.5 log and 2.5 log reductions at the
same time points. The bacterial reductions in XF-73 treated
patients were shown to be highly statistically significant over
placebo at the 1 hour and 2 days post-surgery timepoints
(p<0.0001 and p<0.003, respectively). As a result of the
antibiotic dosing used as standard of care, the 6-day time point
reduction in the placebo group were equivalent to the XF-73 arm
which was expected as it is known (Wilson et al, 1977) that pre-
and post-surgical systemic anti-staphylococcal antibiotic dosing
elicits a slow, gradual reduction in nasal bacterial carriage.
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
Europe's premier antimicrobials congress, the 31st European
Congress of Clinical Microbiology & Infectious Diseases
(ECCMID) in July, 2021. The presentation title was "Repeated doses
of exeporfinium chloride (XF-73) nasal gel over 24 hours
significantly reduced the burden of Staphylococcus aureus nasal
carriage in at-risk surgical patients: preliminary results from a
Phase 2 study."
Destiny Pharma now plans to discuss Phase 3 clinical study
designs with regulatory bodies including the US FDA and CHMP in
Europe. A submission for scientific advice with the Company's
proposals for Phase 3 study designs was made to CHMP in August and
the Company will now continue its review and discuss Phase 3 study
design options with the FDA. The aim is to clarify Phase 3 study
designs and their cost and timeline by the end of 2021. The Phase
2b data package is being shared with interested partners but
clarity is likely to be needed on the US and European Phase 3
clinical study designs before any partnering deals can be
finalised.
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 $1
billion peak sales opportunity in the US alone.
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 USA and Europe
was very positive and adds further support to the NTCD-M3 package
and Destiny Pharma's view that NTCD-M3 has the potential to be a
breakthrough treatment for recurrent CDI and can be priced
accordingly.
In July 2021, a Cooperative R&D agreement was signed with
the US Department of Veterans Affairs to support studies focusing
on identifying new attributes for NTCD-M3. Destiny Pharma will
collaborate on this research project with the Edward Hines Jr. VA
Hospital in Hines, Illinois, utilising their CDI research expertise
to complete new preclinical studies that could support the
administration of NTCD-M3 to a broader CDI patient population and
therefore strengthen the market opportunity. The research project
is planned to complete in Q4 2021.
Stuart Johnson, MD Professor of Medicine, Loyola Stritch School
of Medicine, will lead the team conducting further studies of
NTCD-M3 at the Edward Hines, Jr. VA Hospital, which has long been
recognised for its advanced research into the diagnosis,
epidemiology, prevention and treatment of CDI.
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 March 2021, the Company entered into a Non-Clinical
Evaluation Agreement (NCEA) with the US government's National
Institute of Allergy and Infectious Diseases (NIAID), part of the
US National Institutes of Health, to evaluate the preclinical
safety of a dermal formulation of XF-73. Under NIAID's suite of
preclinical services, NIAID-funded contractors will conduct these
clinically enabling safety studies. Destiny Pharma will utilise
NIAID's preclinical services programme to complete the preclinical
safety studies that will support the planned clinical development
in serious wound infections. Destiny Pharma will provide the XF-73
formulation to be tested in these preclinical studies and the
project is planned to complete in 2022.
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 GBP800,000
Innovate UK grant and is expected to complete at the end of
2021.
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.
Neil Clark
Chief Executive Officer
9 September 2021
Condensed Statement of Comprehensive Income
For the 6 months ended 30 June 2021
6 months ended 6 months ended Year ended
30 June 2021 30 June 2020 31 December
Unaudited Unaudited 2020
GBP GBP Audited
GBP
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 30 June 2021
As at As at As at
30 June 2021 30 June 2020 31 December
Unaudited Unaudited 2020
GBP GBP Audited
GBP
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
-------------------------------- ---------------- -------------- -------------
10,514,243 13,704,559
TOTAL ASSETS ) 6,205,334 ) )
-------------------------------- ---------------- -------------- -------------
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
-------------------------------- ---------------- -------------- -------------
10,514,243 13,704,559
TOTAL EQUITY AND LIABILITIES ) 6,205,334 ) )
-------------------------------- ---------------- -------------- -------------
Condensed Statement of Changes in Equity
For the 6 months ended 30 June 2021
Issued share Share Accumulated
capital premium losses Total
GBP GBP GBP GBP
As at 1 January 2021 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
598,619 27,091,466 10,164,806
As at 30 June 2021 ) ) (17,525,279) )
------------------------------ ------------- ----------- -------------- --------------
Issued share Share Accumulated
capital premium losses Total
GBP GBP GBP GBP
As at 1 January 2020 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
438,652 17,296,337 5,387,822
As at 30 June 2020 ) ) (12,347,167) )
---------------------- ------------- ----------- -------------- --------------
Issued share Share Accumulated
capital premium losses Total
GBP GBP GBP GBP
As at 1 January 2020 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
598,169 27,085,506 12,436,425
As at 31 December 2020 ) ) (15,247,250) )
------------------------------ ------------- ----------- -------------- --------------
Condensed Statement of Cash Flows
For the 6 months ended 30 June 2021
6 months ended 6 months ended Year ended
30 June 2021 30 June 2020 31 December
Unaudited Unaudited 2020
GBP GBP Audited
GBP
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 (54,461) 113,260 (379,293)
Increase/(decrease) in trade
and other payables (918,696) 19,373 469,995
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 9,744,217 7,479,642 7,479,642
---------------------------------------- --------------- --------------- -------------
Cash and cash equivalents at
the end of the period 7,058,284 5,571,631 9,744,217
---------------------------------------- --------------- --------------- -------------
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 2021, six months ended 30 June 2020 and the year ended 31
December 2020 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 2020 is based on the statutory accounts for the year ended
31 December 2020. 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 2020 are also unaudited.
The interim financial statements for the six months ended 30
June 2021 were approved by the Board on 8 September 2021.
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 2020 and expected to be adopted in the financial year
ending 31 December 2021.
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 6 months ended Year ended
30 June 2021 30 June 2020 31 December
Unaudited Unaudited 2020
GBP GBP Audited
GBP
Loss for the period from
continuing operations (2,488,578) (2,430,171) (5,411,077)
-------------------------- --------------- --------------- -------------
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
GBP
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
-------------------------------- -----------
Plant and
machinery
GBP
Cost
At 1 January 2020 118,089
Additions 1,859
At 30 June 2020 119,948
-------------------------------- -----------
Depreciation
At 1 January 2020 85,167
Charge for the period 9,017
At 30 June 2020 94,184
-------------------------------- -----------
Net book value at 30 June 2020 25,764
-------------------------------- -----------
Property, plant and equipment (contd.)
Plant and
machinery
GBP
Cost
At 1 January 2020 118,089
Additions 2,099
At 31 December 2020 120,188
------------------------------------ -----------
Depreciation
At 1 January 2020 85,167
Charge for the year 16,881
At 31 December 2020 102,048
------------------------------------ -----------
Net book value at 31 December 2020 18,141
------------------------------------ -----------
7. Intangible assets
Acquired
development
programmes
GBP
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 2020 -
Additions -
Cost and Net book value at 30 June 2020 -
----------------------------------------
Cost
At 1 January 2020 -
Additions 2,261,435
Cost and Net book value at 31 December 2020 2,261,435
--------------------------------------------- ----------
8. Share capital
On 21 January 2021 180,436 Employee LTIP 2020 Options were
granted to the following employees: William Love 45,095, Shaun
Claydon 39,230, Neil Clark 53,053 and Jesus Gonzalez 43,058. These
options have been granted at a price of GBP0.01 per ordinary share
and will vest on the second anniversary of the date of grant.
On 12 May 2021 Jesus Gonzalez left the Company forfeiting
492,242 Options he held in the Company.
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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END
IR FZGGLVRKGMZM
(END) Dow Jones Newswires
September 09, 2021 02:00 ET (06:00 GMT)
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