TIDMSBTX
RNS Number : 1878J
SkinBioTherapeutics PLC
19 August 2021
19 August 2021
SkinBioTherapeutics plc
("SkinBioTherapeutics" or "the Company")
Business Update - Correction
This is restatement of the announcement published at 07:00 on 19
August 2021 (RNS number 1501J) to correct the manufacturing
scale-up volume of SkinBiotix from the originally stated "20,000
cubic metres" to " 20 cubic metres".
All other details remain unchanged. The full corrected
announcement is set out below.
SkinBioTherapeutics plc
("SkinBioTherapeutics" or "the Company")
Business Update
-- AxisBiotix-Ps(TM) now regulatory compliant in the US, UK and EU;
-- Commercial launch of AxisBiotix-Ps(TM) remains on track for Q4 2021;
-- Further analysis of the AxisBiotix data set shows some
encouraging potential for other skin conditions including eczema,
acne and rosacea;
-- SkinBiotix manufacturing scale-up with Croda progressing to schedule;
-- Cash at 30 June 2021 GBP4.6m (31 December 2020 GBP5.5m)
SkinBioTherapeutics plc (AIM: SBTX), a life science company
focused on skin health, has today provided a business update
including an update on plans for commercialisation of
AxisBiotix-Ps(TM) as committed to in the announcement of 26 May
2021 . In summary, o perationally, the Company has made significant
progress with its plans to launch AxisBiotix-Ps(TM) in Q4 2021 and
scale-up SkinBiotix to commercial volumes. Financially, the Company
ended the 12 months to 30 June 2021 with a solid cash balance of
GBP4.6m (31 December 2020: GBP5.5m).
AxisBiotix-Ps (TM)
Study results
In May 2021 the Company reported on the outcomes of the study
for participants that self-identified as suffering from psoriasis.
For the full report, please visit the AxisBiotix website
www.axisbiotix.com. The results were very positive and provided
definitive support for the commercial development of
AxisBiotix-Ps(TM) which will be launched in Q4 2021 as a probiotic
food supplement to help alleviate the symptoms of psoriasis.
Even though the study was originally designed for participants
who self-identified with psoriasis, people with other skin
conditions e.g. acne, eczema and rosacea also joined the study. The
number of non-psoriatic participants was relatively small, but
analysis of the data set from those who completed the study at day
56 was very promising.
-- Psoriasis +
Participants in the study who self-identified as suffering from
psoriasis and at least one other skin condition. Of these, 80%
reported a reduction in itchiness and 85% reported that their skin
felt less irritable.
-- Eczema
Participants who self-identified as suffering only from eczema
reported the following results:
-- 71% reported that their skin felt less itchy;
-- 71% reported that their skin felt less irritable;
-- 64% reported a reduction in redness; and
-- 64% a reduction in 'flaky patches' on their skin.
-- Acne and rosacea
The small group of participants who self-identified with these
conditions reported improvements to their skin conditions. Due to
the size of the group, a larger cohort would be needed before
statistics are published.
These early indicative study results with other participants are
very interesting and support the Company's aim to expand the
AxisBiotix pipeline beyond psoriasis into other targeted skin
conditions. The development of new AxisBiotix products would
require the addition of condition-specific probiotic strains to the
core strain, which would then be tested through similar participant
studies to the most recent psoriasis study.
Commercialisation on track for Q4 2021
The Company has been preparing for the commercial launch of
AxisBiotix-Ps(TM) since the completion of the study and has made
excellent progress. To date, the team has been finalising the
regulatory pathway and commercial strategy, preparing the marketing
campaigns and establishing a reliable and robust supply chain.
The AxisBiotix-Ps(TM) product is regulatory compliant in the US,
the UK and Europe.
The commercial strategy is to target the US and UK markets
initially, with the EU following very shortly after. Excluding
shipping and any duty costs, the product will be marketed on a
subscription basis and priced per sachet in the US at $2.00 (USD),
in the UK GBP1.50 (GBP), and in Europe EUR1.80 (EUR) and sold in
boxes containing 28 sachets.
To create a ready-made market for the product at launch, the
Company is conducting a multi-media marketing strategy to encourage
further pre-registration of interest from potential customers. Upon
launch, the product will then be released on a controlled basis to
both test the supply chain and ensure continuity of supply for
subscribers.
Croda - progressing well to create a bioactive for cosmetics
skincare
Croda and its active ingredient arm Sederma, continue to
progress the development of SkinBiotix (R) as the foundation for an
active skincare ingredient. The project is progressing through the
increasing levels of manufacturing scale-up which is now at 600
litres and will then move to 20 cubic metres (final step for the
worldwide market) in September 2021 and in line with the agreed
project plan.
Stuart Ashman, CEO of SkinBioTherapeutics, said:
"We are very pleased with the progress the Company has been able
to make over the first half of this year, both with
AxisBiotix-Ps(TM) and SkinBiotix (Croda).
"AxisBiotix-Ps(TM) is now regulatory compliant in the UK, US and
EU and our focus is to continue building a robust supply chain and
drive forward the commercialisation process in order to launch the
product, on a controlled basis, in Q4 of this year as planned.
"We are also taking a keen interest in the results from
participants self-identifying as suffering from eczema, acne or
rosacea. These initial study results give us the confidence to
undertake additional studies and commence the development of
additional potential products targeted at assisting in alleviating
skin conditions such as these."
-Ends-
The information communicated within this announcement is deemed
to constitute inside information as stipulated under the Market
Abuse Regulations (EU) No. 596/2014 and has been arranged for
release by Doug Quinn, CFO of the Company. Upon the publication of
this announcement, this inside information is now considered to be
in the public domain.
For more information please contact:
SkinBioTherapeutics plc Tel: +44 (0) 161
Stuart J . Ashman, CEO 468 2760
Doug Quinn, CFO
Cenkos Securities Plc (Nominated Adviser Tel: +44 (0) 20 7397
& Broker) 8900
Giles Balleny, Max Gould (Corporate Finance)
Michael Johnson, Dale Bellis (Sales)
Instinctif Partners (financial press) Tel: +44 (0) 20 7457
Melanie Toyne-Sewell / Nathan Billis 2020
SkinBio@instinctif.com
About SkinBioTherapeutics plc
SkinBioTherapeutics is a life science company focused on skin
health. The Company's proprietary platform technology,
SkinBiotix(R), is based upon discoveries made by Prof. Catherine
O'Neill and Professor Andrew McBain.
The Company has demonstrated, through scientific testing, that
the SkinBiotix(R) platform can improve the barrier effect of skin
models, protect from infection and repair wounds. Proof of
principle studies have also shown that the SkinBiotix(R) platform
has beneficial attributes applicable to each of these areas. The
technology achieved positive results in clinical studies in human
volunteers in early 2019.
The Company listed on AIM in April 2017 and is based in
Manchester, UK. For more information, visit: www.skinbiotix.com
.
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END
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