TIDMDEST
RNS Number : 2268Z
Destiny Pharma PLC
17 September 2020
Destiny Pharma plc
("Destiny Pharma" or the "Company")
Interim results for the six months ended 30 June 2020
Lead product to prevent post-surgical infections in Phase 2b
clinical trial
Recruitment planned to complete by end of 2020; results expected
in Q1 2021
Grant funded COVID-19 collaboration announced
Company funded to Q4 2021
Brighton, United Kingdom - 17 September 2020 - 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 2020 and an update for the year to
date.
Operational highlights
Phase 2b clinical trial: XF-73 nasal gel for prevention of
post-surgical infections
-- Protocol amendment agreed with FDA and Phase 2b XF-73 nasal
study size revised to 125 patients with recruitment planned to
complete by end of 2020
-- Quality of study and statistical quality of Phase 2b not affected by reduction in size
-- Positive interim safety analysis of Phase 2b trial performed
by independent data monitoring committee
-- Good recruitment momentum post COVID-19 delays. Refer to
separate Clinical Update announced today
Financial highlights
-- Strong cash position with cash and term deposits at 30 June
2020 of GBP5.6 million (30 June 2019: GBP9.1 million; 31 December
2019: GBP7.5 million)
-- Expenditure on R&D in the period of GBP2.3 million
(half-year 2019: GBP1.7 million; full year 2019: GBP3.8 million)
reflecting the increased investment in clinical research
-- Company funded through to Q4 2021
SporeGen COVID-19 collaboration
-- Destiny Pharma and SporeGen announced collaboration and
Innovate UK grant award of GBP800,000 to co-develop a novel,
preventative product for COVID-19
-- Expands Destiny Pharma's novel pipeline targeted at preventing infections with novel biologics/microbiome approach
Earlier pipeline and research projects
-- Research projects with Cardiff, Sheffield, Southampton and
Aston Universities making progress after COVID-19 delays
-- New grant awarded by National Biofilms Innovation Centre
(NBIC) to fund a second research collaboration with Cardiff
University in oral infections
-- Oxford University review supports the unique target profile
of XF-73 and its potential to address the threat of anti-microbial
resistance (AMR)
Neil Clark, CEO of Destiny Pharma, commented:
"Destiny Pharma has made great progress in 2020. We agreed a
protocol amendment with the US FDA and announced a good interim
safety review on our important Phase 2b study of our lead drug
candidate, XF-73, for the prevention of post-surgical hospital
infections. We now look forward to completing patient recruitment
by the end of 2020 and announcing results in Q1 2021. This is the
major value driver for the company.
We remain very positive on the 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 pipeline of unique infection prevention products has
recently been expanded with SPOR-COV, a novel, preventative
treatment for COVID-19. This product is being co-developed with
SporeGen Ltd and supported by an GBP800,000 Innovate UK grant.
COVID-19 has highlighted vividly the healthcare impact of
infectious disease and we are 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, Shabnam Bashir, Manel Mateus
+44 (0)20 3174 1789
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
About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative
biotechnology company focused on the development and
commercialisation of novel medicines that can prevent life
threatening infections. The company's lead programme is undergoing
a Phase 2b clinical trial and is targeting the prevention of
post-surgical hospital infections including MRSA. The XF drug
candidates are being developed for the prevention and treatment of
life-threatening infections caused by antibiotic--resistant
bacteria, often referred to as "superbugs". Tackling anti-microbial
resistance has become a global imperative recognised by the World
Health Organization (WHO) and the United Nations, as well as the G7
and the G20 countries. Destiny Pharma is also collaborating with
SporeGen(R) to co-develop a novel, preventative product for
COVID-19. For further information, please visit
https://www.destinypharma.com
Forward looking statements
Certain information contained in this announcement, including
any information as to the Group's strategy, plans or future
financial or operating performance, constitutes "forward-looking
statements". These forward looking statements may be identified by
the use of forward-looking terminology, including the terms
"believes", "estimates", "anticipates", "projects", "expects",
"intends", "aims", "plans", "predicts", "may", "will", "seeks"
"could" "targets" "assumes" "positioned" or "should" or, in each
case, their negative or other variations or comparable terminology,
or by discussions of strategy, plans, objectives, goals, future
events or intentions. These forward-looking statements include all
matters that are not historical facts. They appear in a number of
places throughout this announcement and include statements
regarding the intentions, beliefs or current expectations of the
Directors concerning, among other things, the Group's results of
operations, financial condition, prospects, growth, strategies and
the industries in which the Group operates. The directors of the
company believe that the expectations reflected in these statements
are reasonable, but may be affected by a number of variables which
could cause actual results or trends to differ materially. Each
forward-looking statement speaks only as of the date of the
particular statement. By their nature, forward-looking statements
involve risks and uncertainties because they relate to events and
depend on circumstances that may or may not occur in the future or
are beyond the Group's control. Forward looking statements are not
guarantees of future performance. Even if the Group's actual
results of operations, financial condition and the development of
the industries in which the Group operates are consistent with the
forward-looking statements contained in this document, those
results or developments may not be indicative of results or
developments in subsequent periods.
Chief Executive Officer's Statement
Operational review summary
The Company's lead asset, XF-73, has been developed from Destiny
Pharma's novel, antimicrobial "XF" drug platform. Unlike most
antibiotics, XF drugs have not been seen to generate bacterial
resistance in industry-standard microbiology tests and therefore
have significant potential to address the global threat of
anti-microbial resistance (AMR).
XF-73 has been shown to kill bacteria very rapidly and is
planned to be an effective new treatment in the reduction of
bacterial infections in hospital patients after surgery, including
those caused by methicillin resistant Staphylococcus aureus (MRSA).
XF-73 is administered topically as a nasal gel whereby it reduces
the nasal carriage of the bacteria Staphylococcus aureus, which is
the source of many post-surgical bacterial infections. There is
currently no approved product in the US for the reduction of
post-surgical staphylococcal infections although approximately a
third of all patients have nasal Staphylococcal aureus carriage as
they enter surgery.
This strong clinical need is supported by feedback from 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 the commercial plans
for XF-73 nasal gel as a new hospital product in a poorly served
multi-billion dollar market.
The addition of SPOR-COV, a COVID-19 preventative treatment, to
our pipeline through a new collaboration with SporeGen Limited is
confirmation of our strategy to enlarge our pipeline and is an
exciting move into the biologicals/microbiome sector. The potential
of this asset was validated by the concurrent award of an
GBP800,000 Innovate UK grant.
Phase 2b clinical trial
The Phase 2b clinical study is recruiting patients undergoing
open heart surgery in United States and Europe and has now
recruited 88 patients out of the target of 125. Barring any further
impact from COVID-19 the study is on plan to complete recruitment
by the end of 2020 and report results in Q1 2021.
In July, Destiny Pharma agreed a protocol amendment with the FDA
that reduced the size of the study and also reported excellent
interim safety data. Importantly the reduced size of the study does
not compromise its integrity, statistical relevance or clinical
objectives.
The agreed protocol amendment recognised the impact COVID-19 has
had in slowing patient recruitment in clinical studies since March
and the FDA's willingness to support certain protocol amendments
that help to accelerate the completion of ongoing clinical trials
but do not compromise a study's integrity and clinical objectives.
The amendment to the protocol incorporated a change to the primary
patient population where the primary endpoint for the study will be
measured. The primary microbiological endpoint post-surgery is now
being measured in patients who have a positive load of nasal
Staphylococcus aureus before receiving the study treatment. This
contrasts to the original primary population, which included all
randomised patients regardless of their baseline nasal load of
Staphylococcus aureus. Very importantly, this change enabled a
reduction in the defined study size from 200 patients to 125 while
maintaining the statistical power of the study and its clinical
value. This preserved the potential of the trial results to be a
key step towards the Phase 3 clinical trial programme of XF-73.
Other protocol modifications agreed with the FDA regarding study
procedures will also make it easier for hospitals to recruit and
retain hospital patients
An interim safety review was completed by an Independent Data
Monitoring Committee (IDMC) of the Phase 2b study. The committee
reviewed safety data from the first 75 patients who completed study
treatment. Adverse event data, including safety laboratory results,
incidence of post-operative infections, ear, nose, and throat
examinations, as well as sense of smell tests were reviewed by the
IDMC. Based on their evaluation, the IDMC recommended that the
study could continue without any modifications to the protocol.
SPOR-COV - a new COVID-19 project
Earlier this month Destiny Pharma entered into a collaboration
agreement with SporeGen Limited to co-develop SporeGen's SPOR-COV
product as a novel, preventative treatment for COVID-19.
Under the agreement, the parties will share any costs and
commercial returns from SPOR-COV and plan to complete a
pre-clinical programme with the aim of being ready to enter the
first human clinical trials within 18 months.
The SPOR--COV product consists of a proprietary formulation of
Bacillus bacteria that will be administered nasally as a spray.
SPOR-COV has already been shown by SporeGen to provide complete
(100%) protection in preclinical models of influenza virus.
SPOR-COV is different to vaccines in that it utilises the innate
immune system with the aim of developing COVID-19 protection a few
days after dosing. As an "easy to use" first line of defence, it
has the potential to reduce COVID-19 infection rates and
transmission significantly. The final SPOR-COV product is planned
to be straightforward to produce at high volumes and at low cost.
It can also be stockpiled almost indefinitely without the need for
cold chain refrigeration. It could be made available globally as a
cost-effective measure in the fight against COVID-19 as well as new
COVID strains and other respiratory viral infections.
The SPOR-COV programme is supported by an Innovation UK grant of
GBP800,000 which will fund the majority of the GBP1 million cost of
the initial SPOR-COV programme.
XF Research update
The Company's earlier pipeline is largely funded through
non-dilutive grant funding. These projects are looking at the
utility of XF compounds in preventing and/or treatment of
infections in ocular, respiratory, dermal and oral indications.
Progress on these projects has been slowed due to COVID-19 and the
associated restrictions on University based laboratory work but
activity is planned to increase in the last quarter of 2020.
.
The pipeline was expanded further in in the first half of 2020
as Destiny Pharma was jointly awarded a National Biofilms
Innovation Centre (NBIC) grant to fund a research collaboration
with Cardiff University. The project will establish the potential
of three of the Company's proprietary XF drug compounds, DPD--207,
XF-70 and XF-73 as novel treatments for clinically important fungal
infections in mucosal mouth models of disease.
The promising no/low resistance profile of XF-73 was supported
by the publication of a new independent paper in Trends in
Microbiology, entitled: "Assessing the potential for Staphylococcus
aureus to evolve resistance to XF-73".
The review looked at data from a number of established
microbiology models that were used to evaluate the action of XF-73
in killing S. aureus that were carried out previously by Destiny
Pharma. The paper concluded that the available evidence suggests
that S. aureus has low potential to evolve resistance to XF-73
relative to antibiotics. This conclusion supports the Company's own
view that XF-73 has a unique resistance profile due to its novel,
ultra-fast mechanism of action that is a key advantage compared to
typical antibiotics.
Outlook
Destiny Pharma is well funded to complete the Phase 2 clinical
development of its lead drug asset, XF-73. The Company is currently
designing the Phase 3 clinical study that will hopefully follow.
Importantly, market analysis supports the clinical need and
commercial opportunity for XF-73 in the prevention of post-surgery
hospital infections, such as those caused by MRSA, which is
estimated to be over a $1 billion market opportunity in the US
alone.
Six grant awards worth over GBP2.5 million have been awarded to
Destiny Pharma projects since 2018 and are being used to help
develop new clinical candidates from the Company's XF pipeline and
the SPOR-COV project. This demonstrates the potential value in
Destiny's growing pipeline. The Company is well funded to execute
on its business strategy and to progress its lead and follow-on
programmes through the planned clinical studies in 2020 with a cash
runway that extends to Q4 2021.
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 highlighted clearly
the global need for innovation that delivers fast, safe and
affordable anti-infection treatments.
Neil Clark
Chief Executive Officer
17 September 2020
Condensed Statement of Comprehensive Income
For the 6 months ended 30 June 2020
6 months ended 6 months ended Year ended
30 June 2020 30 June 2019 31 December
Unaudited Unaudited 2019
GBP GBP Audited
GBP
Continuing operations
Revenue - - -
Administrative expenses (2,912,801) (2,556,773) (5,687,003)
Other operating income 12,450 198,474 305,906
Share option charge (58,668) (109,454) (203,655)
----------------------------- --------------- --------------- -------------
Operating loss (2,959,019) (2,467,753) (5,584,752)
Finance income 13,470 40,316 63,478
----------------------------- --------------- --------------- -------------
Loss before tax (2,945,549) (2,427,437) (5,521,274)
Income Tax 515,378 332,413 813,250
----------------------------- --------------- --------------- -------------
Loss for the period (2,430,171) (2,095,024) (4,708,024)
Other comprehensive income - - -
----------------------------- --------------- --------------- -------------
Total comprehensive loss
from continuing operations (2,430,171) (2,095,024) (4,708,024)
----------------------------- --------------- --------------- -------------
Loss per share (Note 5)
Basic and diluted (5.5)p (4.8)p (10.7)p
----------------------------- --------------- --------------- -------------
Condensed Statement of Financial Position
For the 6 months ended 30 June 2020
As at As at As at
30 June 2020 30 June 2019 31 December
Unaudited Unaudited 2019
GBP GBP Audited
GBP
ASSETS
Non-current assets
Property, plant and equipment
(Note 6) 25,764 38,031 32,922
Current assets
Trade and other receivables 559,747 1,259,349 911,198
Prepayments and accrued income 48,192 186,157 133,702
Cash and cash equivalents 5,571,631 5,077,954 7,479,642
Other financial assets - 4,000,000 -
Current assets 6,179,570 10,523,460 8,524,542
-------------------------------- -------------- -------------- -------------
TOTAL ASSETS 6,205,334 10,561,491 8,557,464
-------------------------------- -------------- -------------- -------------
EQUITY AND LIABILITIES
Current liabilities
Trade and other payables 817,512 283,367 798,139
-------------------------------- -------------- -------------- -------------
Current liabilities 817,512 283,367 798,139
-------------------------------- -------------- -------------- -------------
Shareholders' equity
Issued share capital (Note
7) 438,652 438,652 438,652
Share premium 17,296,337 17,296,337 17,296,337
Accumulated losses (12,347,167) (7,456,865) (9,975,664)
-------------------------------- -------------- -------------- -------------
Total shareholders' equity 5,387,822 10,278,124 7,759,325
-------------------------------- -------------- -------------- -------------
TOTAL EQUITY AND LIABILITIES 6,205,334 10,561,491 8,557,464
-------------------------------- -------------- -------------- -------------
Condensed Statement of Changes in Equity
For the 6 months ended 30 June 2020
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 - - (2,430,171) (2,430,171)
Share based payment
expense - - 58,668 58,668
As at 30 June 2020 438,652 17,296,337 (12,347,167) 5,387,822
------------------------------ ------------- ----------- -------------- --------------
Issued share Share Accumulated
capital premium losses Total
GBP GBP GBP GBP
As at 1 January 2019 435,626 17,292,284 (5,471,295) 12,256,615
Total comprehensive
loss and loss
for the period - - (2,095,024) (2,095,024)
Issue of share capital 3,026 4,053 7,079
Share based payment
expense - - 109,454 109,454
As at 30 June 2019 438,652 17,296,337 (7,456,865) 10,278,124
------------------------- ------------- ----------- ------------- -------------
Issued share Share Accumulated
capital premium losses Total
GBP GBP GBP GBP
As at 1 January 2019 435,626 17,292,284 (5,471,295) 12,256,615
Loss and total comprehensive
loss for the period
Issue of share capital (4,708,024) (4,708,024)
Share based payment
expense 3,026 4,053 - 7,079
- - 203,655 203,655
As at 31 December 2019 438,652 17,296,337 (9,975,664) 7,759,325
------------------------------ ------------- ----------- ------------- -------------
Condensed Statement of Cash Flows
For the 6 months ended 30 June 2020
6 months ended 6 months ended Year ended
30 June 2020 30 June 2019 31 December
Unaudited Unaudited 2019
GBP GBP Audited
GBP
Cash flows from operating activities
Loss before income tax (2,945,549) (2,427,437) (5,521,274)
Depreciation charges (note
6) 9,017 8,868 18,440
Share based payment expense 58,668 109,454 203,655
Finance income (13,470) (40,316) (63,478)
Decrease/(increase) in trade
and other receivables and prepayments 113,260 (145,928) (79,800)
Increase/(decrease) in trade
and other payables 19,373 518,425 (3,653)
Tax received 839,079 - 815,316
---------------------------------------- --------------- ----------------------- -------------
Net cash used in operating
activities (1,919,622) (3,013,784) (4,630,794)
---------------------------------------- --------------- ----------------------- -------------
Cash flows from investing activities
Purchase of tangible fixed
assets (1,859) (16,478) (20,942)
Maturity of other financial
assets - 5,000,000 5,000,000
Purchase of other financial - (4,000,000) -
assets
Interest received 13,470 40,316 63,478
Net cash flow from investing
activities 11,611 1,023,838 5,042,536
---------------------------------------- --------------- ----------------------- -------------
Cash flows from financing activities
New shares issued net of issue
costs - 7,079 7,079
---------------------------------------- --------------- ----------------------- -------------
Net cash inflow from financing
activities - 7,079 7,079
---------------------------------------- --------------- ----------------------- -------------
Net decrease in cash and cash
equivalents (1,908,011) (1,982,867) 418,821
Cash and cash equivalents at
the beginning of the period 7,479,642 7,060,821 7,060,821
---------------------------------------- --------------- ----------------------- -------------
Cash and cash equivalents at
the end of the period 5,571,631 5,077,954 7,479,642
---------------------------------------- --------------- ----------------------- -------------
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 2020 and for the six months ended 30
June 2019 contained within this interim report do not comprise
statutory accounts within the meaning of section 434 of the
Companies Act 2006.
In the opinion of the Directors, the interim consolidated
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 2019 are also
unaudited.
The interim financial statements for the six months ended 30
June 2020 were approved by the Board on 16 September 2020.
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 2019 and expected to be adopted in the financial year
ending 31 December 2020.
IFRS16 'Leases' became applicable to the Company on 1 January
2019. The Company has elected not to apply the requirements of
paragraphs 22 to 49 of IFRS16 in relation to short term leases and
has no material leases which are other than short term. The
adoption of IFRS16 therefore had no impact on the unaudited interim
financial statements and no adjustments were required as a
consequence of its adoption.
4. Segmental Information
The chief operating decision-maker is considered to be the Board
of Directors of Destiny. 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
has one operating segment, the 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 2020 30 June 2019 31 December
Unaudited Unaudited 2019
GBP GBP Audited
GBP
Loss for the period from
continuing operations (2,430,171) (2,095,024) (4,708,024)
-------------------------- --------------- --------------- -------------
Weighted average number
of shares 43,865,195 43,733,614 43,799,945
Loss per share - pence
-------------------------- --------------- --------------- -------------
Basic and diluted (5.5)p (4.8)p (10.7)p
-------------------------- --------------- --------------- -------------
6. Property, plant and equipment
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 9017
At 30 June 2020 94,184
-------------------------------- -----------
Net book value at 30 June 2020 25,764
-------------------------------- -----------
Plant and
machinery
GBP
Cost
At 1 January 2019 97,147
Additions 16,478
At 30 June 2019 113,625
-------------------------------- -----------
Depreciation
At 1 January 2019 66,726
Charge for the period 8,868
At 30 June 2019 75,594
-------------------------------- -----------
Net book value at 30 June 2019 38,031
-------------------------------- -----------
Property, plant and equipment (contd.)
Plant and
machinery
GBP
Cost
At 1 January 2019 97,147
Additions 20,942
At 31 December 2019 118,089
------------------------------------ -----------
Depreciation
At 1 January 2019 66,726
Charge for the year 18,440
At 31 December 2019 85,167
------------------------------------ -----------
Net book value at 31 December 2019 32,922
------------------------------------ -----------
7. Share capital
On 18 June 2019, 150,000 Employee LTIP options in respect of
Shaun Claydon were cancelled.
On 19 June 2019, 125,000 Employee LTIP Options were granted to
Shaun Claydon and 40,000 Employee LTIP Options were granted to
Jesus Gonzalez. These options have been granted at a price of
GBP0.01 per ordinary share and for Shaun Claydon the Options will
vest on 26 October 2021. The options granted to Jesus Gonzales will
vest on the third anniversary of the date of grant. Both Option
grants are exercisable for ten years after the date of grant.
8. Events after the end of the reporting period
There are no events subsequent to the reporting period that
require adjustment or disclosure.
9. 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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