TIDMREDX
RNS Number : 6485Z
Redx Pharma plc
17 May 2023
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF EU REGULATION 596/2014 AS IT FORMS PART OF DOMESTIC
LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018.
REDX PHARMA PLC
("Redx" or the "Company")
Interim Results for the Six Months Ended 31 March 2023
Focus on progressing industry-leading ROCK portfolio with RXC007
Phase 2a trial on track to deliver topline data Q1 2024 and RXC008
CTA submission expected H2 2023
RXC004 combination modules open for enrolment with topline data
expected H2 2023
Redx funded through significant value inflection points;
evaluating all options to extend cash runway beyond Q1 2024
Alderley Park, UK, 17 May 2023 Redx (AIM:REDX), the
clinical-stage biotechnology company focused on discovering and
developing novel, small molecule, targeted therapeutics for the
treatment of fibrotic disease and cancer announces its unaudited
financial results for the six month period ended 31 March 2023.
Lisa Anson, Chief Executive Officer, Redx Pharma commented:
"During the six months to 31 March 2023 the Company has prioritised
our industry-leading ROCK portfolio where we have made very
significant progress. Our lead asset RXC007, a next-generation
selective ROCK2 inhibitor, is progressing well through a Phase 2a
clinical trial in idiopathic pulmonary fibrosis (IPF), with topline
data expected in Q1 2024. Our first-in-class GI-targeted ROCK
inhibitor, RXC008, is on track for a CTA submission in H2 2023 to
become our second ROCK programme in clinical development. We also
look forward to the important RXC004 Phase 2 combination data due
at the end of 2023 and remain well positioned to deliver multiple
near-term value inflection points."
Operational Highlights:
Advanced RXC007, a next-generation selective ROCK2 inhibitor,
with the commencement of the Phase 2a dose escalation study in
IPF:
-- On 11 October 2022, the first patient was dosed in Phase 2a
IPF study. The study has been approved in 6 European countries with
14 sites open and patient recruitment is progressing well and on
track to deliver topline data Q1 2024;
-- Recruitment into the translational science sub-study opened
in the UK and under an IND in US, with additional nonclinical work
ongoing to support longer dosing durations in the US;
-- On 2 October and 10 November 2022, encouraging preclinical
data were presented at ICLAF and AFDD respectively, supporting
expansion into additional interstitial lung diseases;
-- Post period, an initial safety review in the first eight
patients dosed at 20mg BID confirmed no safety signals to date,
supporting the planned dose escalation;
-- Post period, on 10 May 2023, preclinical data highlighting
potential in cancer-associated-fibrosis were presented at the
Resistant Tumour Microenvironment, Keystone Symposia.
Progressed RXC008, a GI-targeted ROCK inhibitor being developed
as a potential first-in-class treatment for fibrostenotic Crohn's
disease, through IND-enabling studies with a CTA submission planned
in 2023:
-- On 23 November 2022, preclinical data were presented at the
IBD Nordic Conference showing RXC008 can suppress fibrosis in
animal models of GI fibrosis.
Commenced patient recruitment into the combination programme for
RXC004, a small molecule Porcupine inhibitor being developed for
the treatment of Wnt-ligand dependent cancers, which is
investigating the primary efficacy hypothesis to overcome immune
evasion in combination with anti-PD-1:
-- On 10 November 2022, Phase 1 combination data presented at
the Society for Immunotherapy of Cancer Conference (SITC) showed an
acceptable tolerability and PK profile in this patient population
supporting a dose of 1.5mg in combination with an anti-PD-1 in the
Phase 2 trial. The Phase 2 modules of RXC004 in combination with
anti-PD-1 in both PORCUPINE and PORCUPINE2 continue to recruit,
with data expected to report at the end of 2023;
-- On 16 December 2022, a clinical trial collaboration and
supply agreement was announced with MSD (Merck & Co., Inc.) for
the supply of Keytruda(R) [1] (pembrolizumab) for the PORCUPINE2
biliary tract cancer combination module;
-- On 8 March 2023, initial Phase 2 data were reported from the
monotherapy biliary tract cancer (BTC) module, with some patients
experiencing durable clinical benefit. The overall safety and
efficacy profile was in line with the Phase 1 study;
-- All monotherapy modules have now been closed for further
recruitment enabling the single agent profile of RXC004 to be
characterised for future partnership and regulatory discussions,
whilst streamlining the study design to prioritise resources and
patients to combination arms.
Financial Highlights:
-- Cash balance at 31 March 2023 of GBP34.6 million (31 March
2022: GBP31.6 million), sufficient to fund the Company into Q1
2024. The Company is financed to deliver key project milestones
including RXC007 Phase 2a data, RXC008 CTA submission and RXC004
combination data readout;
-- R&D expenses for the period of GBP16.1 million (31 March 2022 GBP12.9 million);
-- Loss for the period of GBP20.8 million (31 March 2022 GBP9.8
million), driven by lower revenue, higher R&D expense and
reverse merger transaction expenses;
-- Post period on 3 April, a recommended all-share business
combination with Jounce Therapeutics, Inc. ("Jounce"), announced on
23 February, was terminated following the withdrawal by the board
of directors of Jounce of its recommendation for the combination,
in favour of an unsolicited all-cash offer from another party,
which the board of directors of Jounce felt to be in the best
interest of Jounce's shareholders;
-- The Company continues to evaluate alternative options to extend cash runway beyond Q1 2024.
As previously announced, the Company will hold a live webcast of
the 2023 interim results presentation at 12pm GMT (7am EST) today.
Attendees can register via the following link:
https://webcast.openbriefing.com/redxpharma-may23/ and the
presentation will be available for replay on the Company's website
at:
https://www.redxpharma.com/investor-centre/presentations-analyst-reports-documents-and-videos/
.
The person responsible for the release of this announcement on
behalf of the Company is Claire Solk, Company Secretary.
For further information, please contact:
Redx Pharma Plc T: +44 (0)162 546 9918
UK Headquarters
Caitlin Pearson, Head of Communications
ir@redxpharma.com
Lisa Anson, Chief Executive Officer
US Office
Peter Collum, Chief Financial Officer
SPARK Advisory Partners (Nominated Adviser) T: +44 (0)203 368 3550
Matt Davis/ Adam Dawes
WG Partners LLP (Joint Broker) T: +44 (0)203 705 9330
Claes Spång/ Satheesh Nadarajah/ David Wilson
Panmure Gordon (UK) Limited (Joint Broker) T: +44 (0)207 886 2500
Rupert Dearden/ Freddy Crossley/ Emma Earl
FTI Consulting T: +44 (0)203 727 1000
Simon Conway/ Ciara Martin
About Redx Pharma Plc
Redx Pharma (AIM: REDX) is a clinical-stage biotechnology
company focused on the discovery and development of novel, small
molecule, targeted therapeutics for the treatment of fibrotic
disease, cancer and the emerging area of cancer-associated
fibrosis, aiming initially to progress them to clinical proof of
concept before evaluating options for further development and
potential value creation. The Company's lead fibrosis product
candidate, the selective ROCK2 inhibitor RXC007, is in development
for interstitial lung disease and commenced a Phase 2a trial for
idiopathic pulmonary fibrosis (IPF) in October 2022, with topline
data expected in Q1 2024. Redx's lead oncology product candidate,
the Porcupine inhibitor RXC004, being developed as a targeted
treatment for Wnt-ligand dependent cancers, is expected to report
combination with anti-PD-1 Phase 2 data during 2023. Redx's third
drug candidate, RXC008, a GI-targeted ROCK inhibitor for the
treatment of fibrostenotic Crohn's disease, is progressing towards
a CTA application at the end of 2023.
The Company has a strong track record of discovering new drug
candidates through its core strengths in medicinal chemistry and
translational science, enabling the Company to discover and develop
differentiated therapeutics against biologically or clinically
validated targets. The Company's accomplishments are evidenced not
only by its two wholly-owned clinical-stage product candidates and
rapidly expanding pipeline, but also by its strategic transactions,
including the sale of pirtobrutinib (RXC005, LOXO-305), a
non-covalent (reversible) BTK inhibitor now approved by the US FDA
for adult patients with mantle cell lymphoma previously treated
with a covalent BTK inhibitor, and AZD5055/RXC006, a Porcupine
inhibitor targeting fibrotic diseases including IPF, which
AstraZeneca is progressing in a Phase 1 clinical study. In
addition, Redx has forged collaborations with Jazz Pharmaceuticals,
which includes JZP815, a pan-RAF inhibitor developed by Redx which
Jazz is now progressing through Phase 1 clinical studies, and an
early stage oncology research collaboration.
To subscribe to Email Alerts from Redx, please visit:
www.redxpharma.com/investor-centre/email-alerts/ .
Chief Executive's Statement
During the six months ended 31 March 2023, we have continued to
execute our core strategy to develop potential best-in-class or
first-in-class therapeutics in areas of high unmet medical
need.
We have prioritised the development of our industry-leading ROCK
portfolio and are particularly excited by the potential of the lead
programme, RXC007, a next-generation selective ROCK2 inhibitor
which is progressing through a Phase 2a clinical trial in IPF. The
ROCK portfolio also includes a potential first-in-class programme,
RXC008, a GI-targeted ROCK1/2 inhibitor which is advancing towards
the clinic as a potential treatment for fibrostenotic Crohn's
disease. RXC004, the Company's lead oncology asset, continues to
recruit patients to the combination modules of the Phase 2
programme and we expect initial topline data by the end of 2023.
Additionally, our discovery pipeline has continued to advance key
research programmes towards our goal of two further INDs by the end
of 2025.
The cash balance at the end of the period of GBP34.6 million
funds our programmes into Q1 2024 and through multiple near-term
value inflection points. During the period, we have rigorously
reviewed our expenses and portfolio to prioritise resources towards
the areas where we see the highest impact on clinical benefit,
commercial returns and value creation for shareholders.
An industry-leading ROCK portfolio
Redx has developed a unique portfolio of multiple distinct
assets targeting Rho-associated protein kinase (ROCK), a known
nodal point for pro-fibrotic signalling central to fibrosis in a
range of fibrotic conditions. Our medicinal chemistry expertise and
deep understanding of the ROCK target has allowed successful
development of these programs through optimising molecular
properties in areas such as exposure, drug-drug interaction and
selectivity.
With RXC007, we have used our medicinal chemistry expertise to
selectively target ROCK2, historically known to be a very
challenging target, for the treatment of interstitial lung disease
(ILD), with an initial focus on IPF where ROCK2 is upregulated.
Taking a different approach with RXC008, we have developed a
GI-targeted ROCK1/2 inhibitor which is in preclinical development
for the treatment of fibrostenotic Crohn's disease. RXC008 is
specifically designed to avoid the potential cardiovascular
side-effects of systemic ROCK1/2 inhibition by being restricted to
the GI tract with any breakthrough rapidly degraded in plasma.
RXC007 - Currently in Phase 2a for IPF, with potential in a
number of other fibrotic conditions
RXC007, a next-generation selective inhibitor of ROCK2 commenced
a Phase 2a trial in IPF in October 2022.
The Phase 2a trial is a randomised, dose escalation study with
and without standard of care agents. Three cohorts, each consisting
of 16 patients with 12 receiving RXC007, will be dosed with an
escalating dose of RXC007, with the key endpoints being safety, PK
profile, changes from baseline in lung function - Forced Vital
Capacity (FVC) and Carbon Dioxide Diffusion Coefficient (DLCO),
changes from baseline in Quantitative Lung Fibrosis Score and
airway volume and resistance on high resolution computerised
tomography (HRCT) scan. The initial dosing period will last for 12
weeks; however, patients may continue for longer if there are no
signs of disease progression or toxicity. The data collected will
inform the potential dose we take forward into a larger Phase 2b
study, which will be powered to detect an efficacy signal based on
the current regulatory endpoint of FVC change over 12 months.
Recruitment into the Phase 2a study is on track with the initial
safety review for the first eight patients, dosed at 20mg BID,
completed with no safety signals to date, enabling recruitment and
dose escalation to continue. The study is currently approved in 6
countries across Europe with 14 active study sites open and with
further sites expected to be active by the end of H1 2023. Based on
current recruitment rates, we expect to report topline data during
Q1 2024, as previously communicated.
In parallel with the main study, a translational science
sub-study is ongoing to demonstrate the effect on disease
biomarkers. In total, 16 patients will be recruited into this study
and dosed with RXC007 for 28 days, with endpoints including changes
from baseline in blood biomarkers, proteins and genes from
broncho-alveolar lavage (BAL) fluid and BAL-fluid cells and
bronchial epithelial cells. An open IND in the US is allowing
enrolment into the 28-day translational science sub-study with
longer dosing currently under an FDA partial clinical hold pending
the data readout from an ongoing nonclinical study. The requested
data, at clinically relevant doses, is expected later this
year.
Selective ROCK2 inhibition - a novel approach to fibrotic
disease
Treatments for IPF have remained largely stagnant since the 2014
approval of pirfenidone and nintedanib, both of which have been
shown to slow but not halt or reverse the effect of fibrosis, and
which have significant tolerability issues for a large percentage
of patients, limiting their use.
Based on current biological knowledge, targeting downstream
pathways is most likely to be effective in treating clinically
overt disease[2]. ROCK sits downstream of a number of competitor
targets including the TGF-<BETA>, CTGF and LPA pathways, all
of which signal, or partially signal, through ROCK. As a known
nodal point in these signalling cascades, by selectively targeting
ROCK2, RXC007 can act pleiotropically, an important characteristic
of approved antifibrotic compounds.
ROCK2 inhibition is now a commercially validated target with
potential in multiple disease areas, following the FDA approval and
launch of the first drug with this mechanism of action for the
treatment of chronic graft versus host disease (cGvHD).
In addition to the ongoing clinical development plan in IPF,
which accounts for around one third of patients with a significant
lung pathology, we have also generated consistently supportive
preclinical data that highlights the broad potential of
next-generation ROCK2 inhibitors across a number of fibrotic
indications where there remains a significant unmet need.
We presented proof-of-concept data at the International
Colloquium on Lung and Airway Fibrosis (ICLAF) on 2 October 2022
that detailed development work in immune mediated models of cGvHD,
where the underlying disease mechanisms that drive pathology in the
model show similarities to those observed in the lung pathology of
auto-immune driven fibrotic diseases such as systemic sclerosis and
ILD. The data presented showed the pleiotropic, anti-fibrotic
effects of RXC007, which when dosed orally and therapeutically, was
able to significantly reduce skin thickness, fibrosis and collagen
deposition in the skin and lungs.
Beyond lung fibrosis, encouraging data from an ongoing
collaboration with the Garvan Institute of Medical Research (the
"Garvan"), presented at the Antifibrotic Drug Development Summit
(AFDD) on 10 November 2022, showed the potential of Redx's ROCK2
inhibitors in cancer-associated fibrosis, such as that seen in
pancreatic cancer. Post period, on 10 May 2023, preclinical data
showing the effect of RXC007 in an aggressive patient derived
xenograft model of pancreatic ductal adenocarcinoma in combination
with standard of care (SoC) chemotherapy, were presented at the
Resistant Tumour Microenvironment, Keystone Symposia. The data
observed showed a striking increase in survival when RXC007 was
combined with SoC chemotherapy, compared to SoC chemotherapy
alone.
These data add to an extensive preclinical data package which
supports opportunities in multiple fibrotic indications, including
the wider ILD indications being planned for in the future Phase 2b
study. They also support the exploration of RXC007 in
cancer-associated fibrosis, such as that seen in advanced
pancreatic cancer, thereby presenting a novel opportunity in a
disease area with both a high unmet need and the potential for
accelerated development in combination with standard first line
chemotherapy regimens, which we aim to commence early in 2024.
As our RXC007 clinical activities continue to mature, we have
also filed a proposed International Non-proprietary Name (INN),
zelasudil, which we expect to become active in June 2023.
RXC008 - On track for a CTA submission during H2 2023
RXC008 is a potent, oral, small molecule non-systemic
GI-targeted ROCK inhibitor designed to act exclusively in the GI
tract at the site of fibrosis in Crohn's disease. RXC008 is
currently undergoing IND enabling studies to allow the submission
of a Clinical Trial Authorisation (CTA) during H2 2023, which would
allow the commencement of a first-in-man Phase 1 study in 2024.
RXC008 is a potential first-in-class treatment for fibrostenotic
Crohn's disease, for which no therapeutic treatment is currently
available, meaning patients must endure invasive, and often
multiple, surgeries. RXC008 has shown in vivo efficacy in animal
fibrosis models and ex vivo efficacy in human tissue from Crohn's
disease patients.
During the period, results from adoptive transfer and chronic
dextran sulphate sodium (DSS) studies were presented at the
Inflammatory Bowel Disease Nordic (IBD Nordic) Conference in
November 2022. These studies, undertaken in collaboration with
Ghent University, also incorporated the use of non-invasive
magnetic resonance imaging (MRI) texture analysis and histology to
assess reduction in tissue injury and fibrosis, and is something
that we aim to use translationally in our clinical studies moving
forward. Of note, the most compelling preclinical data were seen in
a therapeutic 12-week DSS model with a closely related GI-targeted
ROCK inhibitor, REDX08087, which was able to fully reverse fibrosis
back to baseline levels when the compound was administered orally
once a day from weeks 6 to 12, once fibrosis was established. We
were able to show complete reversal of preformed GI fibrosis as
measured by trichome collagen staining, with this level of
anti-fibrotic effect the strongest we have seen in any of Redx's
fibrosis models and modes of action to date.
RXC004 - primary efficacy hypothesis in combination with
anti-PD-1 expected to read out at the end of 2023 with a view to
partnering for future development
RXC004 is an orally active, once daily, Porcupine inhibitor in
Phase 2 development as a targeted treatment for Wnt-ligand
dependent cancers.
The primary efficacy hypothesis for RXC004 is in combination,
which we are initially exploring clinically with anti-PD-1 therapy,
where it is believed to overcome immune evasion and anti-PD-1
resistance in late-stage hard-to-treat tumour types. However, due
to its mechanism of action, there is further potential to combine
with MAPK pathway inhibitors given the significant co-occurrence of
both BRAF and KRAS mutations in Wnt-ligand dependent tumours, as
well as with chemotherapy.
The Phase 2 development programme consists of two studies,
PORCUPINE, evaluating RXC004 as both monotherapy and in combination
with an anti-PD-1 checkpoint therapy, nivolumab (OPDIVO(R)[3] -
Bristol Myers Squibb) , in genetically selected MSS mCRC; and
PORCUPINE2, as monotherapy in genetically selected pancreatic
cancer and as monotherapy and in combination with anti-PD-1
therapy, pembrolizumab (KEYTRUDA(R)[4]) in unselected Biliary Tract
Cancer (BTC). The objective of the Phase 2 programme is to provide
an initial assessment of the efficacy and safety of RXC004.
During the period, we presented enabling Phase 1 combination
data at the Society for Immunotherapy of Cancer (SITC) Conference
in November 2022, which confirmed the selection of 1.5mg as the
dose to take forward and duly supported the decision to open
enrolment into the Phase 2 combination modules. Recruitment into
the Phase 2 combination modules of the RXC004 programme is ongoing
and we expect to report topline data at the end of 2023. Given the
highest potential opportunity to develop RXC004 is in combination,
following these data read outs Redx aims to seek a partner to
develop RXC004 more broadly in combination with other agents.
On 8 March 2023, the first data from the Phase 2 programme were
announced from 16 previously treated patients enrolled in the
advanced unselected BTC monotherapy arm of the PORCUPINE2 study,
the primary endpoint of which was progression free survival at six
months. The initial data showed some patients received durable
clinical benefit from RXC004, consistent with clinical activity
seen in the earlier Phase 1 trial, which Redx believes is notable
given few drugs have received regulatory approval as single agents
in this treatment setting. The data also showed that the safety
profile of RXC004 in this module was consistent with that reported
in Phase 1. Whilst an encouraging demonstration of potential for
RXC004's contribution to efficacy in a combination therapy, the
overall results were not sufficient to support the further
development by Redx of RXC004 as a monotherapy in BTC.
The emerging single agent profile of RXC004 with the BTC
monotherapy data reported to date is showing modest clinical
benefit and supportive of the primary efficacy hypothesis in the
combination setting. In light of this, and the fact that it has
taken longer than initially anticipated to identify patients in the
genetically selected pancreatic and MSS mCRC monotherapy modules, a
trend that has been evidenced across the industry landscape, we
have made the decision to close further patient recruitment for all
monotherapy. This will enable us to prioritise both patient
recruitment and resources into the combination modules which we
expect to report at the end of 2023 as planned.
Discovery Engine - Progressing towards two further INDs by end
of 2025
Our approach to discovery has historically been to select
biologically or clinically validated targets where we believe our
capabilities can solve historical challenges, including those
associated with resistance, dosing and pharmacokinetics,
tolerability or drug-drug interactions. This approach is evidenced
both with RXC007 which we believe has the potential to be a
best-in-class molecule, as well as the recent US FDA approval of
Jaypirca(TM) (pirtobrutinib), during the period. Pirtobrutinib , a
non-covalent (reversible) BTK inhibitor, was originally discovered
and developed by Redx[5] and is the first Redx-discovered molecule
to receive a marketing authorisation.
We continue to progress towards our goal of two further INDs by
the end of 2025 and have a pipeline of undisclosed research
programmes ongoing. The most advanced of these is the Discodin
Domain Receptor (DDR) programme. DDRs are receptor tyrosine kinases
containing a discoidin homology domain in their extracellular
region and which act as non-integrin collagen receptors. There are
two DDR receptors, DDR1 and DDR2, and DDR expression is increased
in many fibrotic diseases. DDRs have recently gained traction as
new druggable targets with the potential to treat multiple fibrotic
conditions, including kidney fibrosis. Redx has generated
compelling preclinical data on REDX12271, a novel, potent,
selective and orally active DDR1 inhibitor, in chronic kidney
disease models, which were presented at the American Society of
Nephrology Kidney Week (ASN) in November 2022. The data presented
showed that selective inhibition of DDR1 with REDX12271 reduces
inflammation and fibrosis in prophylactic Murine Unilateral
Ureteral Obstruction (UUO) models, and to our knowledge this is the
first example of selective inhibition of DDR1 with a small molecule
giving rise to efficacy in mouse UUO models.
Finance
Our cash balance at the end of the period of GBP34.6 million
provides funding into Q1 2024 and enables the delivery of several
significant value inflection points , including Phase 2a data in
IPF. The increase in our R&D expenditure to GBP16.1 million (31
March 2022: GBP12.9 million) results from the expansion of our
clinical trial activities. Although no milestones from partnerships
were received during the period, the revenue reported of GBP2.3
million is as a result of the revenue recognition from our ongoing
collaboration with Jazz Pharmaceuticals. Driven by higher R&D
expenses and lower revenue for the period, in addition to one-time
reverse merger transaction expenses, the Loss from Operations of
GBP20.8 million was higher than the comparative period (31 March
2022: GBP9.8 million).
Management remain highly focused on efficiently allocating
resources, including conducting a detailed prioritisation review of
all programmes and expenses, to ensure delivery of important value
inflection points. The Board and management continue to explore all
financing and other strategic options to extend the cash runway in
the best interests of all our shareholders.
Outlook
During the period under review, we continued to advance our
clinical and preclinical programmes towards significant value
inflection points, with a focus on our industry-leading ROCK
portfolio. We remain very enthused by the data to date from our
clinical portfolio, and the overall momentum within our pipeline.
Whilst disappointed that the announced merger with Jounce did not
complete, we remain well positioned to deliver multiple near-term
value inflection points. Redx retains the foundations for longer
term success and shareholder value creation and our Board will
continue to explore all options to secure the funding required to
further enable this. I look forward to reporting our progress in
due course.
I would like to take this opportunity to thank our employees who
continue to drive the success of the Company through their talent
and commitment, as well as our partners and collaborators who
augment our ability to deliver these potential drugs to patients,
and our shareholders who have continued to show strong support for
the Company.
Lisa Anson
Chief Executive Officer
Consolidated Statement of Comprehensive Loss
Unaudited Unaudited Audited
Half Year Half Year Year to 30
to 31 March to 31 March September
2023 2022 2022
Note GBP000 GBP000 GBP000
Revenue 2 2,311 8,353 18,690
Research and Development
expenses (16,097) (12,913) (28,563)
General and Administrative
expenses (4,747) (5,314) (10,229)
Reverse merger expenses 3 (2,395) - -
Exchange (losses)/gains on
translation (441) 409 2,297
Other operating income 915 625 1,539
------------ ------------ ----------
Loss from operations (20,454) (8,840) (16,266)
Finance income 5 704 8 187
Finance expense 5 (897) (850) (1,725)
------------ ------------ ----------
Loss before taxation (20,647) (9,682) (17,804)
Income tax 6 (119) (81) (201)
------------ ------------ ----------
Loss attributable to owners
of Redx Pharma Plc (20,766) (9,763) (18,005)
Other comprehensive (loss)
/ income
Items that may subsequently
be reclassified to profit
or loss
Exchange difference from
translation of foreign operations (5) 8 31
Total comprehensive loss
for the period attributable
to owners of Redx Pharma
Plc (20,771) (9,755) (17,974)
============ ============ ==========
Pence Pence Pence
Loss per share
From continuing operations
- basic & diluted 7 (6.2) (3.5) (6.1)
Consolidated Statement of Financial Position
Unaudited Unaudited Audited
31 March 31 March 30 September
2023 2022 2022
Note GBP000 GBP000 GBP000
Assets
Property, plant and equipment 2,370 3,047 2,699
Intangible assets 397 403 400
Total non-current assets 2,767 3,450 3,099
--------- --------- ------------
Trade and other receivables 8 5,445 4,881 5,498
Current tax 26 26 26
Cash and cash equivalents 34,610 31,583 53,854
Total current assets 40,081 36,490 59,378
--------- --------- ------------
Total assets 42,848 39,940 62,477
--------- --------- ------------
Liabilities
Current liabilities
Trade and other payables 9 6,546 5,678 5,958
Contract liabilities 10 2,582 11,044 4,893
Borrowings 11 16,526 - 15,731
Lease liabilities 649 599 623
Total current liabilities 26,303 17,321 27,205
Non-current liabilities
Borrowings 11 - 14,971 -
Lease liabilities 1,619 2,268 1,951
Total liabilities 27,922 34,560 29,156
--------- --------- ------------
Net assets 14,926 5,380 33,321
========= ========= ============
Equity
Share capital 12 3,349 2,753 3,349
Share premium 99,501 66,299 99,501
Share-based payment 10,431 6,746 8,199
Capital redemption reserve 1 1 1
Exchange translation reserve 55 37 60
Convertible note reserve 3,524 3,524 3,524
Retained deficit (101,935) (73,980) (81,313)
Equity attributable to shareholders 14,926 5,380 33,321
========= ========= ============
Consolidated Statement of Changes in Equity
Unaudited Unaudited Unaudited Unaudited Unaudited Unaudited Unaudited Unaudited
Capital Exchange
Share Share Share-based redemp'n translation Convertible Retained Total
capital premium payment reserve reserve note reserve deficit equity
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
Movements by half
year
At 30 September
2021 2,753 66,299 4,752 1 29 3,524 (64,226) 13,132
--------- --------- ----------- --------- ------------ ------------- --------- ---------
Loss for the period - - - - - - (9,763) (9,763)
Other comprehensive
income - - - - 8 - - 8
--------- --------- ----------- --------- ------------ ------------- --------- ---------
Total comprehensive
loss for the
period - - - - 8 - (9,763) (9,755)
Transactions with
owners in their
capacity as owners
Share-based
compensation - - 2,003 - - - - 2,003
Release of share
options lapsed
in the period - - (9) - - - 9 -
At 31 March 2022 2,753 66,299 6,746 1 37 3,524 (73,980) 5,380
Loss for the period - - - - - - (8,242) (8,242)
Other comprehensive
income - - - - 23 - - 23
--------- --------- ----------- --------- ------------ ------------- --------- ---------
Total comprehensive
loss for the
period - - - - 23 - (8,242) (8,219)
Transactions with
owners in their
capacity as owners
Issue of ordinary
shares 596 33,972 - - - - - 34,568
Transaction costs
on issue of
ordinary
shares - (770) - - - - - (770)
Share-based
compensation - - 2,362 - - - - 2,362
Release of share
options lapsed
in the period - - (909) - - - 909 -
At 30 September
2022 3,349 99,501 8,199 1 60 3,524 (81,313) 33,321
Loss for the period - - - - - - (20,766) (20,766)
Other comprehensive
loss - - - - (5) - - (5)
--------- --------- ----------- --------- ------------ ------------- --------- ---------
Total comprehensive
loss for the
period - - - - (5) - (20,766) (20,771)
Transactions with
owners in their
capacity as owners
Share-based
compensation - - 2,376 - - - - 2,376
Release of share
options lapsed
in period - - (144) - - - 144 -
At 31 March 2023 3,349 99,501 10,431 1 55 3,524 (101,935) 14,926
========= ========= =========== ========= ============ ============= ========= =========
Consolidated Statement of Cash Flows
Unaudited Unaudited Audited
Half Year Half Year Year to 30
to 31 March to 31 March September
2023 2022 2022
GBP000 GBP000 GBP000
Net cash flow from operating
activities
Loss for the period (20,766) (9,763) (18,005)
Adjustments for:
Income tax 119 81 201
Finance costs (net) 193 842 1,538
Depreciation and amortisation 496 438 886
Share based compensation 2,376 2,003 4,365
Profit on disposal of assets - - (13)
Movements in working capital
(Increase) / decrease in trade
and other receivables and contract
assets (545) 8,694 7,631
(Decrease) / increase in trade
and other payables and contract
liabilities (1,723) 278 (5,593)
Cash (used in) / generated by
operations (19,850) 2,573 (8,990)
Tax credit received 582 8 333
Interest received 601 8 187
------------ ------------ ----------
Net cash (used in) / generated
by operations (18,667) 2,589 (8,470)
------------ ------------ ----------
Cash flows from investing activities
Sale of property, plant and equipment - - 21
Purchase of property, plant and
equipment (164) (158) (262)
Net cash used in investing activities (164) (158) (241)
------------ ------------ ----------
Cash flows from financing activities
Proceeds of share issues - - 34,568
Share issue costs - - (770)
Payment of lease liabilities (408) (408) (816)
Net cash (used in) / generated
by financing activities (408) (408) 32,982
------------ ------------ ----------
Net (decrease) / increase in cash
and equivalents (19,239) 2,023 24,271
Cash and cash equivalents at
the beginning of the period 53,854 29,552 29,552
Foreign exchange difference (5) 8 31
Cash and cash equivalents at
the end of the period 34,610 31,583 53,854
============ ============ ==========
Reconciliation of changes in liabilities arising from financing
activities
Unaudited Unaudited Audited
Half Year Half Year Year to 30
to 31 March to 31 March September
2023 2022 2022
GBP000 GBP000 GBP000
IFRS16 Lease liability
Balance b/fwd 2,574 3,149 3,149
Payment of lease liabilities (408) (408) (816)
Interest on lease liabilities 102 126 241
Balance c/fwd (disclosed
as current and non-current
lease liabilities) 2,268 2,867 2,574
============ ============ ==========
Convertible loan notes
Balance b/fwd 15,731 14,247 14,247
Interest 795 724 1,484
Balance c/fwd (disclosed
as current borrowings) 16,526 14,971 15,731
============ ============ ==========
Notes to the Interim Results
1. Basis of preparation and accounting policies
1.01 Description of Group and approval of the consolidated interim financial statements
Redx Pharma Plc ("Redx" or the "Company") is a limited liability
company incorporated and domiciled in the UK. Its shares are quoted
on AIM, a market operated by The London Stock Exchange. The
principal activity of the Group is drug discovery, preclinical
development and licensing.
The Group's consolidated interim financial statements are
presented in pounds sterling, which is the Group's presentational
currency, and all values are rounded to the nearest thousand
(GBP000) except where indicated otherwise.
The consolidated interim financial statements were approved by
the Board of Directors on 16 May 2023.
1.02 Basis of preparation
The Group's consolidated interim financial statements, which are
unaudited, consolidate the results of Redx Pharma Plc and its
subsidiary undertakings made up to 31 March 2023. The Group's
accounting reference date is 30 September.
The financial information contained in these interim financial
statements does not constitute statutory accounts as defined in
section 434 of the Companies Act 2006. It does not therefore
include all of the information and disclosures required in the
annual financial statements. The financial information for the six
months ended 31 March 2023 and 31 March 2022 is unaudited.
The information for the period ended 30 September 2022 has been
extracted from the statutory accounts for the year ended 30
September 2022, prepared in accordance with UK adopted
International Accounting Standards in conformity with the
requirements of the Companies Act 2006. The statutory accounts were
approved by the Board on 19 December 2022 and delivered to the
Registrar of Companies. The audited financial statements of the
Group in respect of the year ended 30 September 2022 received an
unqualified audit opinion and did not contain a statement under
section 498(2) or (3) of the Companies Act 2006. The audit report
included a reference to a material uncertainty that might cast
significant doubt over the Group's ability to continue as a going
concern, to which the auditors drew attention by way of emphasis
without qualifying their report.
1.03 Significant accounting policies
The accounting policies used in the preparation of the financial
information for the six months ended 31 March 2023 are in
accordance with the recognition and measurement criteria of UK
adopted International Accounting Standards ("IAS") in conformity
with the requirements of the Companies Act 2006 and are consistent
with those adopted in the annual statutory financial statements for
the year ended 30 September 2022.
While the interim financial information included has been
prepared in accordance with the recognition and measurement
criteria of UK adopted International Financial Reporting Standards
("IFRS"), the interim financial statements do not include
sufficient information to comply with IFRS.
1.04 Segmental information
Operating segments are reported in a manner consistent with the
internal reporting provided to the chief operating decision-maker.
The Board of Directors and the Chief Financial Officer are together
considered the chief operating decision-maker and as such are
responsible for allocating resources and assessing performance of
operating segments.
The Directors consider that there are no identifiable business
segments that are subject to risks and returns different to the
core business. The information reported to the Directors for the
purposes of resource allocation and assessment of performance is
based wholly on the overall activities of the Group.
The Group has therefore determined that it has only one
reportable segment.
1.05 Going concern
As part of their going concern review the Directors have
followed the guidelines published by the Financial Reporting
Council entitled "Guidance on the Going Concern Basis of Accounting
and Reporting on Solvency Risks - Guidance for directors of
companies that do not apply the UK Corporate Governance Code". The
Directors have also taken into account recent FRC guidance for
companies in relation to going concern and Covid-19.
The Group is subject to a number of risks similar to those of
other development stage pharmaceutical companies. These risks
include, amongst others, generation of revenues in due course from
the development portfolio and risks associated with research,
development, testing and obtaining related regulatory approvals of
its pipeline products. Ultimately, the attainment of profitable
operations is dependent on future uncertain events which include
obtaining adequate financing to fulfil the Group's commercial and
development activities and generating a level of revenue adequate
to support the Group's cost structure.
The Board have adopted the going concern basis in preparing
these accounts after assessing the Group's cash flow forecasts and
principal risks.
At 31 March 2023 the Group held GBP34.6 million of cash and cash
equivalents. The Group has a history of recurring losses from
operations, including a net loss of GBP20.8 million for the six
months ended 31 March 2023 and an accumulated deficit of GBP101.9
million at that date. In addition, operational cash outflows
continue to be driven by the ongoing focus on the research,
development and clinical activities to advance the programmes
within the Group's pipeline. The Group recorded a net decrease in
cash and cash equivalents of GBP19.2 million for the six months
ended 31 March 2023.
As part of its approval of the Group's interim financial
statements for the six months ended 31 March 2023, the Board
concluded that the Group holds sufficient cash and cash equivalents
to provide a cash runway into February 2024 at currently budgeted
levels and timings of expenditure and also on the assumption that
the Group's convertible loans will be converted into equity of the
Group, or that there will be an extension of the term of those
convertible loans (see further discussion below).
In undertaking the going concern review, the Board has reviewed
the Group's cash flow forecasts to 31 May 2024 (the going concern
period). Accounting standards require that the review period covers
at least 12 months from the date of approval of the financial
statements, although they do not specify how far beyond 12 months a
Board should consider. Further funding is required under the
Board's long-term plan to continue to develop its product
candidates and conduct clinical trials, and the Group requires
significant further finance within this period, and is exploring a
number of different options to raise the required funding. Given
these plans and requirements, a review period of 12 months is
considered appropriate.
The Board has identified and assessed downside risks and
mitigating actions in its review of the Group's cash flow
forecasts. The potential requirement to repay the convertible loan
notes and the ability of the Group to raise further capital are
both circumstances outside the control of the Directors.
Accordingly, the downside risks include severe but plausible
scenarios where external fund raising is not successful, where the
Group underperforms against the business plan, and where the
convertible loan notes are recalled rather than converted or
extended. Mitigating actions include the delay of operating
expenditure for research activities and restriction of certain
discretionary expenditure including capital expenditure. In the
event that the convertible loan notes are not converted or
extended, the stated mitigating actions would be insufficient such
that the Group would need to raise additional capital within the
going concern period and this is outside of the control of the
Directors. Similarly, converting or extending the convertible loan
notes would not provide sufficient free cash flow to allow the
Group to meet its liabilities for at least 12 months from the date
of approval of these financial statements. Based on these
conditions, the Group has concluded that the need to raise further
capital and the potential need to repay the convertible loan notes
represent material uncertainties regarding the Group's ability to
continue as a going concern.
Notwithstanding the existence of the material uncertainties, the
Board believes that the adoption of the going concern basis of
accounting is appropriate for the following reasons:
-- the Directors consider it highly unlikely that the
convertible loan notes will be repaid in August 2023 given that the
conversion price of 15.5p represents a significant discount to the
open market price of Redx Pharma Plc share capital. This discount
is around 52% when compared to the share price at 11 May 2023.
-- the Directors do not currently expect the convertible loan
notes to be recalled in August 2023.
-- based on plans and discussions with its advisors and
investors the Directors have an expectation that further funding
will be obtained.
-- the Group has a track record and reasonable near-term
visibility of meeting expectations under its collaboration
agreements and receiving milestone payments which have the
potential to increase the Group's cash runway but are not included
in the Directors' assessment given they are outside the control of
management .
-- the Group retains the ability to control capital and other
discretionary expenditure and lower other operational spend.
There can be no assurance that the convertible loan notes will
be converted or extended rather than recalled. If the loan notes
are not converted or extended, the Group may not have sufficient
cash flows to support its current level of activities beyond the
maturity date. While the Group has successfully accessed equity and
debt financing in the past, there can be no assurance that it will
be successful in doing so now or in the future. In the event the
loan notes are recalled, or additional financing is not secured,
the Group would need to consider:
-- new commercial relationships to help fund future clinical
trial costs (i.e., licensing and partnerships); and/or
-- reducing and/or deferring discretionary spending on one or
more research and development programmes; and/or
-- restructuring operations to change its overhead structure.
The Group's future liquidity needs, and ability to address those
needs, will largely be determined by the success of its product
candidates and key development and regulatory events and its
decisions in the future. Such decisions could have a negative
impact on the Group's future business operations and financial
condition.
The accompanying financial statements do not include any
adjustments that would be required if they were not prepared on a
going concern basis. Accordingly, the financial statements have
been prepared on a basis that assumes the Group will continue as a
going concern and which contemplates the realization of assets and
satisfaction of liabilities and commitments in the ordinary course
of business.
2. Revenue
Unaudited Unaudited Audited
Half year Half year Year to 30
to 31 March to 31 March September
2023 2022 2022
GBP'000 GBP'000 GBP'000
Revenue from milestones on
scientific programmes - 6,684 10,693
Revenue from research collaboration 2,311 701 6,852
Revenue from research and
preclinical development services - 968 1,145
2,311 8,353 18,690
============= ============= ===========
3. Reverse merger expenses
On 23 February 2023 the Group announced a unanimously
recommended business combination with Jounce Therapeutics , Inc.
("Jounce"). Work continued on the project until, following an
unsolicited cash offer for its shares, the board of directors of
Jounce withdrew its recommendation for the combination on 27 March
2023 in favour of an acquisition by another party. Given the nature
and materiality of the expense, it has been disclosed separately
within the Consolidated Statement of Comprehensive Loss. No further
expense is expected, and the proposed transaction formally lapsed
on 3 April 2023.
4. Share-based compensation
Share options have been issued to certain Directors and staff,
and the charge arising is shown below. The fair value of the
options granted has been calculated using a Black-Scholes
model. 17,570,779 of the options granted are subject to performance
conditions based on scientific, clinical and commercial milestones.
There are no further conditions attached to the vesting of
other options other than employment service conditions.
Unaudited Unaudited Audited
Half Year Half Year Year to 30
to 31 March to 31 March September
2023 2022 2022
Number Number Number
Outstanding at the beginning
of the period 36,560,098 33,577,104 33,577,104
Options granted and vested
in period - - -
Options exercised in period - - (1,558,297)
Options surrendered and lapsed
in period (1,283,758) (616,667) (2,283,709)
Options granted and vesting
in future periods 7,300,000 2,100,000 6,825,000
Outstanding at the end of
the period 42,576,340 35,060,437 36,560,098
============= ============= ============
GBP000 GBP000 GBP000
Charge to Statement of Comprehensive
Loss in period 2,376 2,003 4,365
============= ============= ============
Assumptions used were an option life of 5 years, a risk free
rate of 0.6% - 9.4% and no dividend yield. Other inputs were:
* Volatility 111% - 141%
* Share price at date of grant in a range between 25p
and 81p
* Exercise price in a range between 15.5p and 81p
* Weighted average fair value of each option in a range
between 21.8p and 69.2p
At 31 March 2023, a total of 6,948,168 options were vested.
5. Finance income and expense
Unaudited Unaudited Audited
Half Year Half Year Year to 30
to 31 March to 31 March September
2023 2022 2022
GBP'000 GBP'000 GBP'000
Finance income
Bank and other short-term
deposits 704 8 187
704 8 187
============= ============= ===========
Finance expense
Loan interest 795 724 1,484
Interest on lease liabilities 102 126 241
897 850 1,725
============= ============= ===========
6. Income tax
Unaudited Unaudited Audited
Half Year Half Year Year to
to to 30 September
31 March 31 March 2022
2023 2022
GBP'000 GBP'000 GBP'000
Current income tax
Corporation tax 119 81 199
Amounts in respect of previous
periods - - 2
Income tax charge per the income
statement 119 81 201
========= ========= =============
7. Loss per Share
Basic loss per share is calculated by dividing the net income
for the period attributable to ordinary equity holders by
the weighted average number of ordinary shares outstanding
during the period. In the case of diluted amounts, the denominator
also includes ordinary shares that would be issued if any
dilutive potential ordinary shares were issued following exercise
of share options. The basic and diluted calculations are based
on the following:
Unaudited Unaudited Audited
Half Year Half Year Year to 30
to 31 March to 31 March September
2023 2022 2022
GBP'000 GBP'000 GBP'000
Loss for the period attributable
to the owners of the Company (20,766) (9,763) (18,005)
============
Number Number Number
Weighted average number of
shares
- basic & diluted 334,911,458 275,282,205 294,182,774
============ ============ ===========
Pence Pence Pence
Loss per share - basic & diluted (6.2) (3.5) (6.1)
============ ============ ===========
The loss and the weighted average number of shares used for
calculating the diluted loss per share are identical to those
for the basic loss per share. This is because the outstanding
share options would have the effect of reducing the loss per
share and would therefore not be dilutive under IAS 33 Earnings
per Share.
8. Trade and other receivables
Unaudited Unaudited Audited
31 March 31 March 30 September
2023 2022 2022
GBP'000 GBP'000 GBP'000
Trade receivables - 356 12
VAT recoverable 667 815 909
Prepayments and other receivables 4,675 3,634 4,577
Accrued income 103 76 -
---------- ---------- -------------
5,445 4,881 5,498
========== ========== =============
Included within prepayments other receivables at March 2022,
September 2022 and March 2023 is an o ther receivable of GBP0.6
million which is due after more than one year.
9. Trade and other payables
Unaudited Unaudited Audited
31 March 31 March 30 September
2023 2022 2022
GBP'000 GBP'000 GBP'000
Trade payables 2,181 2,201 2,792
Employee taxes and social
security 268 224 250
Other payables 31 9 18
Accruals 4,066 3,244 2,898
---------- ---------- -------------
6,546 5,678 5,958
========== ========== =============
10. Contract liabilities
Unaudited Unaudited Audited
31 March 31 March 30 September
2023 2022 2022
GBP'000 GBP'000 GBP'000
Contract liabilities 2,582 11,044 4,893
=========== ========== =============
Reconciliation
Balance b/fwd 4,893 4,318 4,318
Contract asset debtor received - 7,427 7,427
Transfer to revenue (2,311) (701) (6,852)
2,582 11,044 4,893
=========== ========== =============
The contract liability relates to a single research collaboration
contract.
11. Borrowings
Unaudited Unaudited Audited
31 March 31 March 30 September
2023 2022 2022
GBP'000 GBP'000 GBP'000
Convertible loan notes
Current 16,526 - 15,731
Non-current - 14,971 -
16,526 14,971 15,731
============= ============ ===============
On 4 August 2020 Redx Pharma Plc issued convertible loan notes
with a value of GBP22.2m. No interest is payable during the
first 3 years, thereafter it is payable at a maximum rate
equal to the US prime rate at that time. The notes are convertible
into Ordinary shares of Redx Pharma Plc, at any time at the
option of the holder, or repayable on the third anniversary
of the issue. The conversion rate is 1 Ordinary share for
each GBP0.155 of convertible loan note held. The convertible
loan notes are secured by a fixed and floating charge over
all the assets of the Group.
As of 31 March 2023, an aggregate of GBP17.1 million in principal
amount was outstanding under the convertible loan notes. This
equates to 110,288,887 Ordinary shares at GBP0.155 per share.
The remaining gross principal of GBP17.1 million has been
discounted at the effective interest rate determined on initial
measurement, resulting in a discounted liability of GBP16.5
million (March 2022 GBP15.0 million, September 2022: GBP15.7
million).
12. Share capital
Unaudited Unaudited Audited
Half Year Half Year Year to 30
to 31 March to 31 March September
2023 2022 2022
Number Number Number
Number of shares in issue
In issue at 1 October 334,911,458 275,282,205 275,282,205
Issued for cash - - 58,070,956
Exercise of share options - - 1,558,297
------------- ------------- ------------
334,911,458 275,282,205 334,911,458
GBP'000 GBP'000 GBP'000
Share capital at par, fully
paid
Ordinary shares of GBP0.01 3,349 2,753 3,349
============= ============= ============
13. Post period end events
On 3 April 2023, Redx Pharma Plc confirmed the formal lapse of
the proposed business combination with Jounce Therapeutics, Inc.
All cost relating to the transaction had been incurred prior to 31
March 2023 and are disclosed within these interim results.
FURTHER INFORMATION FOR SHAREHOLDERS
AIM: REDX
Company number: 07368089
Investor website: http://redxpharma.com/investors
Registered office: Block 33, Mereside, Alderley Park, Macclesfield,
SK10 4TG
Directors: Dr Jane Griffiths (Chair)
Lisa Anson (CEO)
Peter Presland (Non-Executive Director)
Dr Bernhard Kirschbaum (Non-Executive Director)
Sarah Gordon Wild (Non-Executive Director)
Dr Thomas Burt (Non-Executive Director)
Natalie Berner (Non-Executive Director)
Dr Rob Scott (Non-Executive Director)
Company Secretary: Claire Solk
END
[1] KEYTRUDA(R) is a registered trademark of Merck Sharp &
Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ,
USA
[2]
https://invivo.pharmaintelligence.informa.com/IV147701/Harbingers-For-IPF-Drug-Development?utm_source=dailyem&utm_medium=email&utm_term=&utm_campaign=&utm_medium=email&utm_source=sfmc&utm_campaign=In+Vivo+Daily+(Tues+-+Fri)&utm_id=4641751&sfmc_id=204119729
[3] OPDIVO(R) is a registered trademark of Bristol-Myers Squibb
Company
[4] KEYTRUDA(R) is a registered trademark of Merck Sharp &
Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ,
USA
[5] The asset was subsequently sold outright to Loxo Oncology,
now part of Eli Lilly, Redx has no remaining economic interest
Jaypirca (TM) is a trademark owned by or licensed to Eli Lilly and
Company, its subsidiaries, or affiliates
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IR FQLLFXELEBBD
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