TIDMREDX
RNS Number : 4502Q
Redx Pharma plc
18 October 2023
THIS ANNOUNCEMENT, INCLUDING THE APPICES, AND THE INFORMATION
CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION
OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR
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FURTHER, THIS ANNOUNCEMENT IS MADE FOR INFORMATION PURPOSES ONLY
AND DOES NOT CONSTITUTE AN OFFER TO SELL OR ISSUE OR SOLICITATION
TO BUY, SUBSCRIBE FOR OR OTHERWISE ACQUIRE SHARES IN REDX PHARMA
PLC IN ANY JURISDICTION.
THE SECURITIES DISCUSSED HEREIN MAY NOT BE OFFERED OR SOLD IN
THE UNITED STATES, UNLESS REGISTERED UNDER THE U.S. SECURITIES ACT
OF 1933, AS AMED (THE "SECURITIES ACT"), OR PURSUANT TO AN
EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, REGISTRATION
UNDER THE SECURITIES ACT. NO PUBLIC OFFERING OF THE SECURITIES
DISCUSSED HEREIN IS BEING MADE IN THE UNITED STATES AND THE
INFORMATION CONTAINED HEREIN DOES NOT CONSTITUTE AN OFFERING OF
SECURITIES FOR SALE IN THE UNITED STATES AND THE COMPANY DOES NOT
CURRENTLY INT TO REGISTER ANY SECURITIES UNDER THE SECURITIES ACT.
ADDITIONALLY, THE SHARES HAVE NOT BEEN APPROVED OR DISAPPROVED BY
THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR ANY OTHER
SECURITIES COMMISSION OR REGULATORY AUTHORITY IN THE UNITED STATES,
NOR HAVE ANY OF THE FOREGOING AUTHORITIES PASSED UPON ORORSED THE
MERITS OF THE SUBSCRIPTION. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENCE IN THE UNITED STATES.
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. IN ADDITION, MARKET SOUNDINGS WERE TAKEN IN
RESPECT OF THE MATTERS CONTAINED IN THIS ANNOUNCEMENT, WITH THE
RESULT THAT CERTAIN PERSONS BECAME AWARE OF SUCH INSIDE
INFORMATION. UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE
INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN AND SUCH
PERSONS SHALL THEREFORE CEASE TO BE IN POSSESSION OF INSIDE
INFORMATION.
Redx Pharma plc
("Redx" or "the Company")
Proposed Subscription to raise c.GBP14.1 million
Alderley Park, 18 October 2023 - Redx Pharma plc (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, today announces that it
has conditionally raised c.GBP14.1 million (before expenses) by way
of a subscription for 54,074,458 new Ordinary Shares (the
"Subscription Shares") by existing shareholders (the
"Subscription"). The Subscription, which is subject to certain
conditions, will be effected at a price of 26 pence per
Subscription Share (the "Issue Price"), being the closing market
price on 17 October 2023 (the business day prior to the date of
this announcement). The net proceeds of the Subscription will allow
the Company to continue to progress its pipeline, as detailed
further below.
MTS Securities, LLC is acting as exclusive placement agent (the
"Exclusive Placement Agent") in connection with the
Subscription.
Dr Jane Griffiths, Chair of the Board of Directors
commented:
"At Redx we are focussed on developing novel, targeted therapies
for fibrotic disease and cancer in areas of high unmet medical
need. This fundraise enables us to continue the strong progress of
our industry-leading ROCK portfolio, specifically advancing our
ROCK2-selective inhibitor, zelasudil, in idiopathic pulmonary
fibrosis (IPF) and commencing clinical studies for our
gastrointestinal-targeted ROCK inhibitor, RXC008, which has the
potential to be a first-in-class treatment for fibrostenotic
Crohn's disease.
We would like to thank our existing shareholders for their
continued strong support of Redx and our ambition to create world
leading medicines to transform patients' lives ."
Highlights of the Transaction
-- Subscription of c.GBP14.1 million (before expenses) at the
Issue Price by existing shareholders.
-- One of the Redmile Funds, which taken together are the
Company's largest shareholder, is participating in the Subscription
and has agreed to subscribe for 31,548,692 Subscription Shares at
the Issue Price. Sofinnova Partners , an existing Shareholder, is
also participating in the Subscription and has agreed to subscribe
for 7,887,173 Subscription Shares at the Issue Price. In addition,
Polar Capital and Invus, both existing shareholders of the Company,
are also participating in the Subscription, either directly or
through entities in their respective groups.
-- Following completion of the Subscription, the Company
estimates that it will have available cash of approximately GBP28.1
million which is expected to provide the Company with working
capital in order to fund the anticipated progression of its ROCK
portfolio to important value inflection points in 2024, thereby
continuing the delivery of its stated strategy to drive shareholder
value.
-- Redx expects to use the net proceeds of the Subscription, its
existing cash resources and a risk-adjusted forecast of milestone
income from partnered programmes due before the end of 2024 as
follows:
o report topline Phase 2a data from zelasudil IPF clinical trial
which will include early efficacy, safetyand PK/PD data;
o complete additional investigative preclinical studies for
zelasudil to enable a complete response to the FDA partial clinical
hold, allowing for longer dosing durations in the US;
o progress RXC008 into clinical development in fibrostenotic
Crohn's disease by initiating a Phase 1 study in healthy
volunteers;
o report topline Phase 2 data from PORCUPINE and PORCUPINE2
clinical trials of RXC004 as a combination therapy with immune
checkpoint inhibitors in patients with genetically selected MSS
mCRC and unselected biliary tract cancer;
o continue to explore partnerships to advance certain programmes
from the Redx portfolio; and
o for general and administrative working capital into the third
quarter of 2024.
The issue of the Subscription Shares is conditional, inter alia,
on the passing by Shareholders of certain resolutions at a General
Meeting of the Company, which is being convened at the offices of
Cooley (UK) LLP, 22 Bishopsgate, London EC2N 4BQ on 6 November 2023
at 11:00 a.m. (London time). Application will be made to the London
Stock Exchange for the Subscription Shares to be admitted to
trading on AIM ("Admission").
Related Party Transaction
As the Redmile Funds hold 73.26 per cent. of the Existing
Ordinary Shares, Redmile is a related party of the Company pursuant
to the AIM Rules. In addition, as Sofinnova holds 13.16 per cent.
of the Existing Ordinary Shares, Sofinnova is also a related party
of the Company pursuant to the AIM Rules. Consequently, the
participation of Redmile via its fund, RedCo II, and Sofinnova in
the Subscription constitute related party transactions for the
purposes of AIM Rule 13. The independent directors for the purposes
of this transaction (being all Directors other than Natalie Berner,
who is a representative of Redmile and Dr Joseph Anderson, who is a
representative of Sofinnova) consider, having consulted with Spark,
the Company's nominated adviser, that the terms of (i) RedCo II's
subscription for Subscription Shares in the Subscription and (ii)
Sofinnova's subscription for Subscription Shares in the
Subscription are fair and reasonable in so far as Shareholders are
concerned.
Set out below in Appendix I to this Announcement (which forms
part of this Announcement) is an adapted extract from the Circular
proposed to be sent to Shareholders. The Circular, containing the
Notice of General Meeting, will be posted to shareholders later
today and will also be available from the Company's website at:
www.redxpharma.com .
The capitalised terms not otherwise defined in the text of this
Announcement are defined in Appendix II and the glossary is
contained at Appendix III. The expected timetable of principal
events is set out in Appendix IV.
This Announcement should be read in its entirety.
The person responsible for the release of this Announcement on
behalf of the Company is Nischal Hindia, Interim General Counsel
& Company Secretary.
For further information, please contact:
Redx Pharma Plc T: +44 1625 469
918
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: +44 203 368
Matt Davis / Adam Dawes 3550
MTS Securities, LLC (Exclusive Placement Agent) T: +1 212 887
Mark Epstein 2100
WG Partners LLP (Joint Broker) T: +44 203 705
Claes Spång / Satheesh Nadarajah / David Wilson 9330
Panmure Gordon (UK) Limited (Joint Broker) T: +44 207 886
Rupert Dearden / Freddy Crossley / Emma Earl 2500
FTI Consulting T: +44 20 3727
Simon Conway / Ciara Martin 1000
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, zelasudil (RXC007), is in
development for interstitial lung disease and is undergoing a Phase
2a trial for idiopathic pulmonary fibrosis (IPF) with topline data
expected in H1 2024. The Company's second fibrosis candidate,
RXC008, a GI-targeted ROCK inhibitor for the treatment of
fibrostenotic Crohn's disease, is progressing towards a CTA
application during the fourth quarter of 2023. 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 anti-PD-1 combination Phase 2 data during the
first half of 2024, following which Redx will seek a partner for
ongoing development.
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 wholly-owned clinical-stage product candidates and
discovery 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.
This Announcement should be read in its entirety.
Important Notice
This Announcement and the information contained in it is
restricted and is not for release, publication or distribution,
directly or indirectly, in whole or in part, in, into or from the
United States, Canada, Australia, Japan or the Republic of South
Africa or any other jurisdiction in which the same would constitute
a violation of the relevant laws or regulations of that
jurisdiction (each, a "Restricted Jurisdiction"). The offering of
securities mentioned herein have not been, and will not be,
registered under the U.S. Securities Act. The Subscription Shares
may not be offered or sold in the United States, except pursuant to
an exemption from the registration requirements of the U.S.
Securities Act or pursuant to an effective registration statement
filed with the U.S. Securities and Exchange Commission. There will
be no public offer of securities of the Company in the United
States.
This Announcement has been issued by, and is the sole
responsibility, of the Company. No representation or warranty
express or implied, is or will be made as to, or in relation to,
and no responsibility or liability is or will be accepted by MTS
Securities, LLC ("MTS") or by any of their respective affiliates,
directors, officers, employees, advisers or agents as to or in
relation to, the accuracy or completeness of this Announcement or
any other written or oral information made available to or publicly
available to any interested party or its advisers, and any
liability therefore is expressly disclaimed. MTS has not authorised
the contents of, or any part of, this Announcement.
MTS is acting exclusively for the Company and no-one else in
connection with the Subscription and will not regard any other
person as a client in relation to such matters and will not be
responsible to anyone other than the Company for providing the
protections afforded to its clients or for providing advice in
relation to such matters. The responsibilities of SPARK Advisory
Partners Limited ("SPARK") as nominated adviser to the Company are
owed to the London Stock Exchange and the Company and not to any
other person including, without limitation, in respect of any
decision to acquire Subscription Shares in reliance on any part of
this Announcement.
No public offering of Subscription Shares is being made in the
United Kingdom, any Restricted Jurisdiction or elsewhere. The
distribution of this Announcement and the offering of the
Subscription Shares in certain jurisdictions may be restricted by
law. No action has been taken by the Company or MTS that would
permit an offering of such Subscription Shares or possession or
distribution of this Announcement or any other offering or
publicity material relating to such Subscription Shares in any
jurisdiction where action for that purpose is required. Persons
into whose possession this Announcement comes are required by the
Company and MTS to inform themselves about, and to observe, such
restrictions.
The information in this Announcement may not be forwarded or
distributed to any other person and may not be reproduced in any
manner whatsoever. Any forwarding, distribution, reproduction, or
disclosure of this information in whole or in part is unauthorised.
Failure to comply with this directive may result in a violation of
the U.S. Securities Act or the applicable laws of other
jurisdictions.
There are matters set out within this Announcement that are
forward-looking statements. Such statements are only predictions,
and actual events or results may differ materially. Neither the
Company or MTS undertake any obligation to update publicly, or
revise, forward-looking statements, whether as a result of new
information, future events or otherwise, except to the extent
legally required. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
Announcement. No statement in this Announcement is or is intended
to be a pro t forecast or pro t estimate or to imply that the
earnings of the Company for the current or future nancial periods
will necessarily match or exceed the historical or published
earnings of the Company. The price of the Company's Ordinary Shares
and the income from them may go down as well as up and investors
may not get back the full amount invested on disposal of the
Company's Ordinary Shares.
This Announcement is not an offering document, prospectus,
prospectus equivalent document or AIM admission document. It is
expected that no offering document, prospectus, prospectus
equivalent document or AIM admission document will be required in
connection with the Subscription and no such document has been or
will be prepared or submitted to be approved by the Financial
Conduct Authority or submitted to the London Stock Exchange in
relation to the Subscription.
Neither the content of the Company's website nor any links on
the Company's website is incorporated in, or forms part of, this
Announcement.
APPIX I: EXTRACTS FROM THE CIRCULAR
Background to and reasons for the Subscription
Redx is a clinical-stage biotechnology company founded in 2010
and whose Ordinary Shares have traded on AIM since 2015. The
Company is focused on discovering and developing novel, small
molecule, targeted therapeutics for the treatment of fibrotic
disease and cancer, including the emerging area of
cancer-associated fibrosis, that address significant unmet medical
needs. Redx's core strengths in medicinal chemistry and
translational science have enabled the Company to discover and
develop differentiated, novel compounds against biologically or
clinically validated targets. In particular, this expertise has led
to the development of a differentiated portfolio of Rho Associated
Coiled-Coil Containing Protein Kinase (ROCK) inhibitors, as
potentially either best-in-class or first-in-class drug candidates
and Redx has made substantial progress with its wholly-owned
clinical and preclinical stage pipeline. Moving forward, Redx will
prioritise developing its ROCK portfolio through various clinical
stage studies, and will pursue partnerships for the remaining
pipeline candidates, including RXC004 and programmes in the
discovery portfolio.
ROCK Portfolio
Redx's lead fibrosis product, zelasudil (RXC007), is a highly
selective Rho Associated Coiled-Coil Containing Protein Kinase 2
(ROCK2) inhibitor being developed as a potential best-in-class
treatment in fibrosis. ROCK2 is a biologically and clinically
validated target that has been shown to sit at a nodal point in a
cell signalling pathway thought to be central to fibrosis. As a
selective ROCK2 inhibitor, zelasudil has the potential to treat
several fibrotic diseases across various therapeutic areas,
including Idiopathic Pulmonary Fibrosis (IPF) and other progressive
fibrotic interstitial lung diseases (ILD), in highly fibrotic
tumours such as pancreatic cancer, and in widespread multi-organ
fibrosis, such as chronic Graft versus Host Disease (cGvHD).
Zelasudil has demonstrated robust preclinical anti-fibrotic effects
across multiple industry-standard in vivo preclinical models. In
the Phase 1 healthy volunteer study the compound was well tolerated
and demonstrated dose dependent exposure in man at doses predicted
to deliver efficacy. IPF is being targeted as the first indication
for clinical development, and a Phase 2a clinical study in IPF
initiated in the fourth quarter of 2022, with topline clinical data
expected to be reported in the first half of 2024. IPF is a severe
and life-threatening chronic lung condition, with limited treatment
options, which is estimated by GlobalData to affect 170,000
patients globally. IPF has an addressable market opportunity
estimated to be worth $3.6 billion by 2029.
Redx's second ROCK asset and next clinical development candidate
is RXC008, a Gastrointestinal (GI) targeted ROCK inhibitor being
developed as a potential first-in-class treatment for fibrostenotic
Crohn's disease. Crohn's disease affects 1.7 million people
globally and over 70,000 new cases are diagnosed each year. More
than 50 per cent. of patients with Crohn's disease develop
significant fibrosis and stricture formation within ten years after
diagnosis. The current management of fibrotic strictures of the
gastrointestinal tract is primarily surgical as no drugs are
specifically approved for fibrosis, which can progress despite
intervention with anti-inflammatory therapies. RXC008 is a small
molecule designed to have its action within the GI tract, the site
of the fibrotic strictures in Crohn's disease. Any absorbed RXC008
is quickly degraded by enzymes present in the bloodstream thereby
avoiding systemic exposure. Preclinical data in multiple models of
inflammatory bowel disease show robust preclinical efficacy,
including complete reversal of fibrosis in one of the models. Redx
intends to submit a CTA application during the fourth quarter of
2023 which would allow for the commencement of a Phase 1 clinical
trial in the first half of 2024. The proposed Phase 1 study will be
split into three parts which will initially involve single
ascending dose and multiple ascending dose cohorts of healthy
volunteers before moving into the third part with a limited number
of patients with fibrostenotic Crohn's disease. The Phase 1 study
is designed to monitor safety and to confirm minimal systemic
exposure, as well as demonstrating target engagement in the
gastrointestinal tract. Beyond this, Redx has provisional plans for
a Phase 2 proof-of-concept study which has been designed with
expert input from a Clinical Advisory Board, including members from
the Science, Translational & Clinical Andrology Research
Consortium, and will be subject to input from regulatory
authorities.
Programmes for Partnership
Redx's clinical stage oncology product, RXC004, is a highly
potent, orally active Porcupine inhibitor being developed as a
targeted therapy for Wnt-ligand dependent cancer. Porcupine is a
key enzyme in the Wnt signalling pathway, well established as a key
driver of both tumour growth and immune evasion. Redx has completed
recruitment in two multi-arm Phase 2 clinical studies in patients
with Wnt-ligand dependent solid tumours as both a monotherapy, and
in combination with anti-PD-1 immune check point inhibitors and
expects to report topline data during the first half 2024 following
which Redx will seek a partner for ongoing development. In the
Phase 2 programme, Redx is evaluating RXC004 in genetically
selected MSS mCRC as a monotherapy and in combination with
nivolumab, an immune checkpoint inhibitor, as a monotherapy in
genetically selected pancreatic cancer, and as a monotherapy and in
combination with an anti-PD-1, pembrolizumab, in unselected biliary
tract cancer. All three of these cancer types have high unmet need
with limited treatment options and poor 5-year survival rates of
less than 3 per cent. for biliary and pancreatic cancer and 14 per
cent. for MSS mCRC.
Redx's Discoidin Domain Receptor (DDR) inhibitor programme
reached the key milestone of development candidate nomination, as
RXC009, in October 2023. DDRs have recently gained traction as new
druggable targets with the potential to treat multiple fibrotic
conditions, including kidney fibrosis and Redx plans to present
data on the programme at the upcoming American Society of
Nephrology (ASN) Kidney Week meeting.
The Company's major focus for oncology research is a Kirsten rat
sarcoma viral oncogene (KRAS) inhibitor programme, targeting both
G12D selective and multi-KRAS profiles. RAS is the most frequently
mutated oncogene across different cancer types, with KRAS mutations
accounting for approximately 85 per cent. of these mutated
oncogenes. Therefore, KRAS inhibitors targeting multiple commonly
occurring mutations may offer a treatment option for large segments
of colorectal, pancreatic and lung cancer patients for whom
treatment options are currently limited. This programme is in lead
optimisation.
The Company has a very experienced management team led by Lisa
Anson, a well-respected and experienced industry executive and
former President of AstraZeneca in the UK and the ABPI and under
her leadership, the management team have established a focused
strategy aimed at driving shareholder value. Redx's ambition is to
create world leading medicines to transform patients' lives by
becoming a leading biotech company focused on the development of
novel and differentiated targeted medicines. As Redx will now
prioritise clinical development of its ROCK inhibitor portfolio,
the Company will seek to leverage its strength in medicinal
chemistry and proven discovery engine through establishing
partnerships.
Since 2019, Redx has completed three notable partnership deals,
two with Jazz Pharmaceuticals and one with AstraZeneca, with total
remaining potential milestone payments to Redx of approximately
$755 million plus mid-single digit revenue royalties. From these
programmes, Redx has near-term potential milestones of $15 million
and has also identified a number of additional programmes,
including RXC004, for partnership.
Notable Achievements
ROCK Portfolio
Zelasudil
-- On 11 October 2022, Redx announced that the first patient had
been dosed in a Phase 2a IPF clinical trial, which has regulatory
approval in the UK and seven other European countries. This 12-week
multi-cohort, randomised, double-blind, placebo-controlled dose
ranging study will provide early efficacy readouts, safety and
tolerability in IPF patients with or without standard IPF therapy.
Currently, the first cohort of patients has completed dosing at 20
mg BID, with no safety or tolerability findings that precluded dose
escalation, and with 10 of the 16 patients dosed electing to
continue into the open label extension to allow for an additional
12-weeks of dosing. The second cohort of patients being treated
with 50 mg BID is currently recruiting and it is expected that
recruitment into the third cohort of the trial will be completed by
the end of 2023, allowing topline data to be announced during the
first half of 2024.
-- On 21 August 2023, Redx announced that the US FDA had granted
zelasudil Orphan Drug Designation for the treatment of IPF. The
designation provides Redx with various development and commercial
incentives, including market exclusivity, in order to address this
unmet need for patients.
-- Redx has an open IND in the US for zelasudil, however, dosing
for longer than 28 days is currently under an FDA partial clinical
hold based on skeletal muscle findings in dog toxicology studies.
Redx has clear guidance from the FDA on the study requirements to
resolve the partial clinical hold. In addition to sharing the
results from a long term non-clinical dog toxicity study at
clinically relevant doses, the Company has decided to undertake a
13-week investigative dog study to specifically address the FDA's
guidance to show that the toxicity in dog skeletal muscle is
monitorable and reversible. The Company has recently met with the
FDA regarding this study design. Redx believe that the dog is a
highly sensitive species for this observation as no muscle toxicity
was observed in mice following treatment with zelasudil at very
high exposures for up to 26-weeks, and no muscle related adverse
events nor creatine kinase (CK) rises, a biomarker of muscle
damage, have been observed in humans to date. It is expected that a
complete response will be submitted to the FDA during the second
quarter of 2024 which could allow the partial hold to be lifted,
enabling longer-term dosing in subsequent clinical studies in the
US.
-- Redx has presented preclinical data at a number of
significant scientific conferences which supports the development
of zelasudil in other indications including fibrotic oncology. On
11 May 2023, Redx presented preclinical data at the Resistant
Tumour Microenvironment, Keystone Symposia, which showed that
zelasudil, in combination with gemcitabine/Abraxane(R) in
metastatic and high-extra cellular matrix (ECM) patient-derived
PDAC models, increased survival compared to single agent standard
of care alone. This, taken together with other preclinical data
generated, has shown the potential of zelasudil in combination with
standard of care as a potential treatment for cancer-associated
fibrosis which Redx intends to investigate further in highly
fibrotic tumours such as pancreatic cancer, in a future Phase 1
study.
-- Additionally, on 2 October 2022, Redx presented data at the
International Colloquium on Lung and Airway Fibrosis (ICLAF)
conference from murine bleomycin-induced lung fibrosis and murine
sclerodermatous chronic graft versus host disease (GvHD) models
which have similar underlying disease mechanisms to those observed
in auto-immune driven fibrotic diseases such as systemic sclerosis
and interstitial lung disease (ILD). With this preclinical data
showing positive results, Redx also intends to initiate a Phase 2a
study in cGvHD, where there is a clear route to approval and a
significant market opportunity, in the future.
RXC008
-- On 30 March 2022, RXC008, was nominated as a clinical
development candidate as a potential first-in-class treatment for
fibrostenotic Crohn's disease.
-- On 23 November 2022, Redx presented data at the Inflammatory
Bowel Disease Nordic (IBD Nordic) conference showing the effect of
RXC008 in supressing fibrosis and tissue injury in pre-clinical
models of Crohn's disease. The data showed that RXC008 can suppress
fibrosis and attenuate tissue injury in animal models of
GI-fibrosis and has the potential to be developed as a novel
therapy to inhibit fibrotic stricture formation in Crohn's
disease.
-- On 21 February 2023, a Scientific Advisory Board was held
between Redx and key opinion leaders in fibrostenosis in Crohn's
disease to review the Phase 1 study proposal, including the
population for patient part of the study, and to discuss overall
clinical development proposals and potential study designs beyond
Phase 1.
-- On 07 August 2023, Redx completed a scientific advisory
meeting with the MHRA, to review the data which will support a CTA
submission. This included data on drug substance and drug product
specifications, the preclinical toxicology package and the proposed
Phase 1 study design (including predictions for starting dose in
humans, dose escalation and stopping criteria proposals) all of
which were endorsed by the MHRA.
-- The package to support a CTA submission is complete and a
Phase 1 study protocol prepared. Redx is planning to submit a CTA
package in the fourth quarter of 2023 to enable a Phase 1 Healthy
Volunteer Study to commence in the first half of 2024.
Subsequently, Redx intends to submit an IND to allow for US
participation in future patient studies.
Programmes for Partnering
RXC004
-- On 17 May 2023, Redx announced its intention to partner the
RXC004 programme following the data readout from the Phase 2
combination with anti-PD-1 modules in genetically selected MSS mCRC
and pancreatic cancer. Recruitment into these modules is now
closed, with some modules having smaller numbers than original
targets for feasibility reasons. A topline data readout is expected
during the first half of 2024.
-- On 8 March 2023, Redx announced topline data from the Phase 2
monotherapy module in advanced biliary tract cancer from 16
previously treated patients enrolled in 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 emerging single agent profile of the
RXC004 data reported to date is supportive of the primary efficacy
hypothesis in combination with anti-PD-1, and Redx therefore
believe that the most suitable development path for this programme
is to partner with a Company that can further progress its
development in combination with anti-PD-1 and other potential
combination treatment options.
Discovery
-- On 27 October 2022, Redx presented data from its novel
Discoidin Domain Receptor 1 (DDR1) inhibitor programme in chronic
kidney disease models at the American Society of Nephrology (ASN)
Kidney Week. The data presented showed that inhibition of DDR with
REDX12271 reduced inflammation and fibrosis in Unilateral Ureteral
Obstruction Models. Redx has since continued to advance this
programme towards development candidate status, which was reached
in October 2023 with the nomination of RXC009. RXC009 is being
developed for kidney fibrosis, including as a potential treatment
for Alport syndrome. Further data are being presented at the 2023
ASN meeting later this year, following which the Company intends to
partner the programme for further development. Redx has filed
multiple patents claiming distinct chemical series as inhibitors of
DDR.
-- Redx has filed multiple patents applications claiming
distinct chemical series with KRAS activity. To date, Redx has
generated encouraging early data and is continuing to further
expand the preclinical data package.
Partnered Programmes
-- Redx has a successful track-record in establishing meaningful
partnerships with large pharmaceutical companies. Currently, Redx
has three partnerships ongoing with Jazz Pharmaceuticals and
AstraZeneca, with near-term potential milestones of $15 million and
total potential remaining milestones of $755 million, as well as
royalties from these ongoing partnerships:
o On 9 November 2022, Jazz Pharmaceuticals announced that the
first patient had been dosed in the Phase 1 trial of JZP815, the
pan-RAF inhibitor programme developed by Redx and acquired by Jazz
Pharmaceuticals in 2019. To date, $11. 5 million of milestones
payments have been received from this programme.
o RXC006 / AZD5055, a Porcupine inhibitor in development for
fibrotic diseases was licensed to AstraZeneca in 2020 with $17
million in milestones being received to date. AstraZeneca continue
to progress this programme through Phase 1 studies.
o Redx has a further research collaboration with Jazz
Pharmaceuticals for discovery and preclinical development for
targeted cancer therapies on the Ras/RAF/MAP kinase pathway. One
target under this collaboration was discontinued in June 2022 due
to pipeline prioritisation by Jazz, while the second programme
continues to advance towards an IND application. Redx has received
$20 million in milestone payments to date from this
partnership.
Redx's track record in discovering and developing novel,
small-molecule targeted therapeutics was further validated on 23
January 2023, when the Redx discovered pirtobrutinib,
(Jaypirca(TM)) a highly selective kinase inhibitor became the first
and only FDA approved non-covalent (reversible) BTK inhibitor
available. Pirtobrutinib was sold to Loxo Oncology, now part of Eli
Lilly, in 2017 and Redx has no remaining economic interest.
The Company has sufficient resources to fund its priority
programmes into 2024 and through near-term milestones. However,
Redx requires additional capital to fund its currently active and
planned clinical development activity. In particular, this includes
the ongoing work required to enable a complete response to the FDA
in relation to the partial clinical hold in respect of zelasudil
and moving RXC008 into a Phase 1 clinical programme. The Board
believes that the Subscription is in the best interests of
Shareholders in order to provide further cash resources to fund the
Company's strategic plan and to provide flexibility when
considering options upon data readouts in order to determine the
optimal route for value creation for Shareholders. Furthermore,
strong support from existing investors through the Subscription
provides additional confirmation and evidence of the strength of
the Company's assets and focused strategy.
Size of the Subscription and Use of Proceeds
Through the Subscription, the Company has conditionally raised
gross proceeds of GBP14,059,359 (the sterling equivalent of
$17,140,000 as at 17 October 2023) in order to fund the anticipated
progression of its ROCK portfolio to important value inflection
points in 2024, thereby continuing the delivery of its stated
strategy to drive shareholder value. Redx expects to use the net
proceeds of the Subscription, its existing cash resources and a
risk-adjusted forecast of milestone income from partnered
programmes due before the end of 2024 as follows:
-- Report topline Phase 2a data from zelasudil IPF clinical
trial which will include early efficacy, safety and PK/PD data;
-- Complete additional investigative preclinical studies for
zelasudil to enable a complete response to the FDA partial clinical
hold, allowing for longer dosing durations in the US;
-- Progress RXC008 into clinical development in fibrostenotic
Crohn's disease by initiating a Phase 1 study in healthy
volunteers;
-- Report topline Phase 2 data from PORCUPINE and PORCUPINE2
clinical trials of RXC004 as a combination therapy with immune
checkpoint inhibitors in patients with genetically selected MSS
mCRC and unselected biliary tract cancer;
-- Continue to explore partnerships to advance certain
programmes from the Redx portfolio; and
-- For general and administrative working capital into the third quarter of 2024.
As the Company executes its business plan, the Board and
management will continue to ensure that resources are allocated to
allow progression of the project portfolio in the most efficient
way and to assess options on an ongoing basis to ensure that Redx
extracts maximum value from its intellectual property. Following
completion of the Subscription, the Company estimates that it will
have available cash of approximately GBP28.1 million.
Current Financial Summary
On 17 May 2023, Redx announced its unaudited interim results for
the six months ended 31 March 2023. Financial highlights for the
period included net cash of GBP34.6 million (31 March 2022: GBP31.6
million); a loss for the period of GBP16.1 million (six months
ended 31 March 2022: GBP9.8 million loss) and total research and
development expenditure of GBP16.1 million (six months ended 31
March 2022: GBP12.9 million).
Details of the Subscription
Structure and Principal Terms of the Subscription
Pursuant to the Subscription Agreement, the Subscribers, being
existing Shareholders, have conditionally agreed to subscribe for,
and the Company has conditionally agreed to allot and issue, in
aggregate, 54,074,458 Subscription Shares representing gross
proceeds of GBP14,059,359 million (the sterling equivalent of
$17,140,000 as at 17 October 2023).
The Subscription for the Subscription Shares is conditional,
inter alia, on the following:
(i) Resolutions 1 and 3 being passed at the General Meeting;
(ii) in respect of each Subscriber, the representations and
warranties of such Subscriber in the Subscription Agreement being
true and correct as of the date when made and as of the Closing
Date as though made at that time, and all obligations, covenants
and agreements of such Subscriber required to be performed at or
prior to the Closing Date having been performed;
(iii) the representations and warranties of the Company in the
Subscription Agreement being true and correct in all material
respects (except for those which are by their terms qualified by
materiality which shall be true, correct and complete in all
respects) as of the Closing Date as though made at that time, and
all obligations, covenants and agreements of the Company and any
Group Company required to be performed at or prior to the Closing
Date having been performed; and
(iv) Admission having occurred.
The Company has agreed to pay to MTS certain commissions based
on the aggregate value of the Subscription Shares placed to certain
investors at the Issue Price and to pay the expenses incurred in
relation to the Subscription.
Application for Admission
Application will be made to the London Stock Exchange for the
Subscription Shares to be admitted to trading on AIM. Admission is
expected to take place, and dealings on AIM are expected to
commence, at 8:00 a.m. on 7 November 2023.
Effect of the Subscription
The Subscription Shares will, when issued and fully paid, rank
pari passu in all respects with the Existing Ordinary Shares,
including the right to receive all dividends and other
distributions declared, made or paid after Admission. Upon
completion of the Subscription, the Subscription Shares will
represent approximately 13.9 per cent. of the Enlarged Share
Capital.
A summary of the Subscription Agreement is set out in paragraph
3 of Part II (Additional Information) of the Circular.
Related Party Transaction
As the Redmile Funds hold 73.26 per cent. of the Existing
Ordinary Shares, Redmile is a related party of the Company pursuant
to the AIM Rules. In addition, as Sofinnova holds 13.16 per cent.
of the Existing Ordinary Shares, Sofinnova is also a related party
of the Company pursuant to the AIM Rules. Consequently, the
participation of Redmile via its fund, RedCo II and Sofinnova in
the Subscription constitute related party transactions for the
purposes of AIM Rule 13. The independent directors for the purposes
of this transaction (being all Directors other than Natalie Berner,
who is a representative of Redmile and Dr Joseph Anderson, who is a
representative of Sofinnova) consider, having consulted with Spark,
the Company's nominated adviser, that the terms of (i) RedCo II's
subscription for Subscription Shares in the Subscription and (ii)
Sofinnova's subscription for Subscription Shares in the
Subscription are fair and reasonable in so far as Shareholders are
concerned.
General Meeting
The Directors do not currently have sufficient authority to
allot in full the Subscription Shares. Accordingly, the Board is
seeking the approval of the Shareholders to allot the Subscription
Shares at the General Meeting, together with approval to disapply
pre-emption rights.
A notice convening the General Meeting, which is to be held at
11:00 a.m. on 6 November 2023 at the offices of Cooley (UK) LLP, 22
Bishopsgate, London EC2N 4BQ, is set out in the Circular. At the
General Meeting, the following Resolutions will be proposed:
Resolution 1 - An ordinary resolution to authorise the Directors
to allot Ordinary Shares up to an aggregate nominal amount of
GBP540,744.58 being equal to 54,074,458 Subscription Shares.
Resolution 2 - An ordinary resolution to authorise the Directors
to:
(i) allot shares in the Company and to grant rights to subscribe
for or to convert any security into shares in the Company up to an
aggregate nominal amount which represents one third of the Enlarged
Share Capital; and
(ii) allot equity securities in connection with a rights issue
in favour of (i) holders of ordinary shares in proportion to their
respective holdings of ordinary shares; and (ii) to holders of
other equity securities as required by the rights attached to those
securities or as the Directors otherwise consider necessary up to a
maximum nominal amount which represents one third of the Enlarged
Share Capital.
This Resolution is conditional upon Admission and will replace
the equivalent authorities granted at the Company's annual general
meeting held on 14 March 2023.
Resolution 3 - A special resolution to authorise the Directors
to allot the Subscription Shares, pursuant to the authority
conferred on them by Resolution 1, and to dis-apply statutory
pre-emption rights in respect of the allotment of such shares, as
if section 561 of the Act did not apply to such allotment. This
Resolution is conditional upon the passing of Resolution 1.
Resolution 4 - A special resolution to authorise the Directors
generally to allot and issue equity securities for cash pursuant to
the authority conferred on them by Resolution 2, up to an aggregate
nominal amount which represents 10 per cent. of the Enlarged Share
Capital. This Resolution is conditional upon Admission and the
passing of Resolution 2 and will replace the equivalent authorities
granted at the Company's annual general meeting held on 14 March
2023.
The authorities and the powers described in Resolutions 1 and 3
above will (unless previously revoked or varied by the Company in
general meeting) expire on the date 3 months from the passing of
such Resolutions or at the conclusion of the next annual general
meeting of the Company following the passing of the Resolutions,
whichever occurs first. The authorities and the powers described in
Resolutions 2 and 4 above will (unless previously revoked or varied
by the Company in general meeting) expire on the date 15 months
from the passing of such Resolutions or at the conclusion of the
next annual general meeting of the Company following the passing of
the Resolutions, whichever occurs first. The authority and the
power described in Resolutions 1 and 3 above are in addition to any
like authority or power previously conferred on the Directors. The
authority and the power described in Resolutions 2 and 4 above are
in substitution for the authority and power previously conferred on
the Directors pursuant to the like resolutions (being resolutions 6
and 7) passed at the Company's annual general meeting held on 14
March 2023.
Resolutions 1 and 2 are ordinary resolutions and require a
simple majority of those voting in person or by proxy to vote in
favour of the Resolutions. Resolutions 3 and 4 are special
resolutions and will require approval by not less than 75 per cent.
of the votes cast by Shareholders voting in person or by proxy.
Irrevocable Undertakings and Letters of Intent
The Directors, who in aggregate hold 394,154 Ordinary Shares,
representing approximately 0.12 per cent. of the Existing Ordinary
Shares, have irrevocably undertaken to vote in favour of the
Resolutions at the General Meeting.
In addition, the Company has received letters of intent from
RedCo II, RM3, Sofinnova, Polar Capital Funds Plc - Healthcare
Opportunities Fund and Invus Public Equities, L.P., who in
aggregate hold 314,731,169 Ordinary Shares representing
approximately 93.97 per cent. of the Existing Ordinary Shares,
confirming that each of such shareholders intends to cast, or
procure that all the votes attaching to the Ordinary Shares held by
such Shareholders are cast, in favour of the Resolutions at the
General Meeting.
APPIX II: DEFINITIONS
The following definitions apply throughout this Announcement,
unless the context otherwise requires:
Act the Companies Act 2006 (as amended);
Admission the admission of the Subscription Shares
to trading on AIM becoming effective
in accordance with the AIM Rules;
AIM the market of that name operated by
the London Stock Exchange;
AIM Rules the AIM Rules for Companies governing
the admission to and operation of AIM
published by the London Stock Exchange
as amended from time to time;
AIM Rules for Nominated the AIM Rules for Nominated Advisers
Advisers published by the London Stock Exchange
as amended from time to time;
AstraZeneca AstraZeneca AB;
Board or Directors the directors of the Company, as at
the date of this Announcement, whose
names are set out on page 12 of the
Circular;
business day any day (excluding Saturdays and Sundays)
on which banks are open in London for
normal banking business and the London
Stock Exchange is open for trading;
certificated or in in relation to a share or other security,
certificated form a share or other security that is not
in uncertificated form, that is not
in CREST;
Circular or document the circular, dated 18 October 2023;
Closing Date the date of completion of the Subscription;
Closing Price the closing middle market quotation
of an Ordinary Share as derived from
FactSet;
Company or Redx Redx Pharma plc, a company incorporated
in England and Wales with company number
7368089 whose registered office is at
Block 33, Mereside, Alderley Park, Macclesfield
SK10 4TG;
CREST the relevant system (as defined in the
CREST Regulations) for the paperless
settlement of trades and the holding
of uncertificated securities, operated
by Euroclear, in accordance with the
same regulations;
CREST Manual the rules governing the operation of
CREST, as published by Euroclear;
CREST member a person who has been admitted by Euroclear
as a system-member (as defined in the
CREST Regulations);
CREST Participant ID the identification code or membership
number used in CREST to identify a particular
CREST member or other CREST participant;
CREST participant a person who is, in relation to CREST,
a system participant (as defined in
the CREST Regulations);
CREST Regulations the Uncertificated Securities Regulations
2001 (SI 2001 No. 3875), as amended;
CREST sponsor a CREST participant admitted to CREST
as a CREST sponsor;
CREST sponsored member a CREST member admitted to CREST as
a sponsored member (which includes all
CREST Personal Members);
EEA European Economic Area;
Enlarged Share Capital the issued Ordinary Share capital of
the Company immediately following Admission;
EU the European Union;
Euroclear Euroclear UK & International Limited,
the operator of CREST;
Exclusive Placement MTS;
Agent
Existing Ordinary Shares 334,911,458 Ordinary Shares, being entire
share capital of the Company in issue
as at the date of this Announcement;
FactSet FactSet Research Systems Inc., a financial
data and software company based in the
United States;
FCA the Financial Conduct Authority of the
UK
;
Form of Proxy the form of proxy which accompanies
the Circular for use in connection with
the General Meeting;
FSMA the Financial Services and Markets Act
2000 (as amended);
General Meeting the general meeting of the Company to
be held at 11:00 a.m. on 6 November
2023 at the offices of Cooley (UK) LLP,
22 Bishopsgate, London EC2N 4BQ;
Group together the Company and its subsidiary
undertakings and "Group Company" shall
mean the Company and any such subsidiary
undertaking;
Invus Invus Public Equities, L.P.
;
ISIN International Securities Identification
Number;
Issue Price 26 pence per Subscription Share;
Jazz Pharmaceuticals Jazz Pharmaceuticals Ireland Limited;
London Stock Exchange London Stock Exchange plc;
Long Stop Date 10 November 2023, being the long stop
date under the Subscription Agreement;
MTS MTS Securities, LLC;
Notice of General Meeting the notice convening the General Meeting
as set out in Part III of the Circular;
Official List the official list of the FCA pursuant
to Part VI of FSMA, as amended from
time to time;
Ordinary Shares ordinary shares of one penny each in
the capital of the Company;
Polar Capital Polar Capital LLP;
Prospectus Regulation the prospectus regulation rules of the
Rules FCA made under section 73A of FSMA;
Redmile Redmile Group, LLC;
Redmile Funds RM3, RedCo II and other funds advised
or managed by Redmile;
RedCo II RedCo II Master Fund, L.P., a fund advised
and managed by Redmile;
Regulation D Regulation D under the Securities Act
;
Regulation S Regulation S under the Securities Act
;
Regulatory Information a service approved by the London Stock
Service Exchange for the distribution to the
public of announcements and included
within the list on the website of the
London Stock Exchange;
Resolutions the resolutions set out in the Notice
of General Meeting to be proposed at
the General Meeting and set out on pages
26 to 30 of the Circular;
Restricted Jurisdiction the United States, Canada, Australia,
Japan or the Republic of South Africa
and any other jurisdiction where the
extension or availability of the Subscription
or distribution of the Circular or this
Announcement would breach any applicable
law;
RM3 RM Special Holdings 3, LLC an entity
owned directly or indirectly by funds
advised or managed by Redmile;
Securities Act the United States Securities Act of
1933, as amended;
Shareholders holders of the Ordinary Shares;
Sofinnova Sofinnova Crossover 1 SLP;
Spark Spark Advisory Partners Limited, the
Company's nominated adviser;
Subscribers the persons who have agreed to subscribe
for Subscription Shares;
Subscription the conditional Subscription for Subscription
Shares by the Subscribers at the Issue
Price pursuant to the terms of the Subscription
Agreement;
Subscription Agreement the Subscription Agreement relating
to the Subscription dated 18 October
2023 and entered into between the Company
and the Subscribers, a summary of which
is included in paragraph 3 of Part II
(Additional Information) of the Circular;
Subscription Shares the 54,074,458 new Ordinary Shares to
be issued pursuant to the Subscription;
UK or United Kingdom the United Kingdom of Great Britain
and Northern Ireland;
UK MAR the retained version of the EU Market
Abuse Regulation (596/2014) as it forms
part of domestic law in the United Kingdom
by virtue of the European Union (Withdrawal)
Act 2018;
uncertificated or in a share or other security recorded on
uncertificated form the relevant register of the share or
security concerned as being held in
uncertificated from in CREST and title
to which, by virtue of the CREST Regulations,
may be transferred by means of CREST;
and
US or United States the United States of America, its territories
and possessions, any state of the United
States and the District of Columbia.
A reference to GBP is to pounds sterling, being the lawful
currency of the UK.
A reference to $ or US$ is to United States dollars, being
the lawful currency of the US.
APPIX III: GLOSSARY
ABPI the Association of the British Pharmaceutical
Industry;
anti-PD-1 antibody immuno-oncology drug therapy that blocks
PD-1 receptors so T-cells are no longer
inhibited, allowing the patient's own
immune system to attack the tumour;
ASN American Society of Nephrology;
cGvHD chronic Graft versus Host Disease;
CK creatine kinase;
CTA Clinical Trial Application;
DDR Discoidin Domain Receptor;
DDR1 Discoidin Domain Receptor 1;
ECM extra cellular matrix;
ESMO European Society for Medical Oncology;
fibrostenosis fibrosis in the gut of patients with
Crohn's Disease;
GI-targeted focusing on the gastrointestinal tract;
ICLAF International Colloquium on Lung and
Airway Fibrosis;
ILD interstital lung disease;
IND investigational new drug application;
IPF idiopathic pulmonary fibrosis;
KRAS Kirsten rat sarcoma viral oncogene;
monotherapy therapy with a single drug;
MSS mCRC microsatellite stable metastatic colorectal
cancer;
nivolumab generic name for OPDIVO(R), Bristol
Myers Squibb's anti-PD-1 antibody;
Pan-RAF an orally available inhibitor of all
members of the serine/threonine protein
kinase Raf family, including A-Raf,
B-Raf and C-Raf protein kinases, with
potential antineoplastic activity;
PK/PD pharmacokinetic / pharmacodynamic;
Porcupine a target in the Wnt signalling pathway;
RAF Rapidly accelerated fibrosarcoma;
ROCK, ROCK2 Rho-Associated Coiled-Coil Kinase, Rho-Associated
Coiled-Coil Containing Protein Kinase
2;
Wnt ligand a ligand, or molecule that signals by
binding to a site on a target protein,
that drives the Wnt signalling pathway;
and
Wnt signalling pathway group of signal transduction pathways,
made of proteins that pass signals from
outside of a cell through cell surface
receptors to the inside of the cell.
APPENDIX IV: EXPECTED TIMETABLE OF PRINCIPAL EVENTS
Announcement of the Subscription 7:00 a.m. on 18 October
2023
Publication and posting of the 18 October 2023
Circular (including the Notice
of General Meeting) and Forms
of Proxy
Latest time and date for receipt 11:00 a.m. on 2 November
of Forms of Proxy and electronic 2023
appointments of proxies via CREST
General Meeting 11:00 a.m. on 6 November
2023
Announcement of the results of 6 November 2023
the General Meeting
Admission and commencement of 8:00 a.m. on 7 November
dealings in the Subscription Shares 2023
on AIM
Subscription Shares in uncertificated As soon as possible
form expected to be credited to after 8:00 a.m. on 7
accounts in CREST November 2023
Despatch of definitive share certificates Within 10 business days
for the Subscription Shares in of Admission
certificated form
If any of the details contained in the timetable above should
change, the revised times and dates will be notified to
Shareholders by means of a Regulatory Information Service
announcement.
In this Announcement, all references to times and dates are to
times and dates in London, United Kingdom unless otherwise stated.
The timetable above assumes that Resolutions 1 and 3 are passed at
the General Meeting without amendment.
This information is provided by RNS, the news service of the
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END
IOEUBVAROKURAUA
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