TIDMSTX
RNS Number : 5833F
Shield Therapeutics PLC
22 February 2018
This announcement contains inside information for the purposes
of Article 7 of Regulation 596/2014
Shield Therapeutics plc
("Shield" or the "Group")
Business and Trading Update
Change of results date for the year ended 31 December 2017
- Revenues for the year ended 31 December 2017 expected to be
GBP637,000 (2016: GBP304,000), in line with Board expectations
- Year-end unaudited cash position was GBP13.3m (2016: GBP21.0m)
- Cost rationalisation programme being implemented
- Current cash runway extended to at least the end of Q4 2018
- Board leading a full review of Shield's strategic options
- Feraccru remains commercially available through Shield
Therapeutics and it European partners, with more patients than ever
being treated
- Detailed analysis of the AEGIS-CKD pivotal Phase III full
dataset underway and expected to be complete before the end of
March 2018
- Results for the year ended 31 December 2017 will be announced on 11 April 2018
London, UK, 22 February 2018: Shield Therapeutics plc (LSE:STX),
a commercial stage, pharmaceutical company delivering innovative
specialty pharmaceuticals to address patients' unmet medical needs,
with an initial focus on addressing iron deficiency anaemia, today
announces a business update, a brief trading update for the year
ended 31 December 2017 and confirmation that the Board has
initiated a full review of the Company's strategic options.
Feraccru, the Company's lead asset, is approved and marketed in
Europe for the treatment of iron deficiency anemia (IDA), initially
in patients with inflammatory bowel disease (IBD).
Trading update for year ended 31 December 2017:
Trading for FY 2017 was in line with Board expectations and 2018
trading started positively. Revenues for the 12 months ended 31
December 2017 are expected to be GBP637,000 (2016: GBP304,000) with
more patients than ever being treated with Feraccru. At the year
end the Company's unaudited cash position was GBP13.3m (2016:
GBP21.0m).
Business update:
Following announcement of the unexpected and disappointing
initial top-line results from the AEGIS-CKD pivotal Phase III study
of Feraccru, the Company is currently reviewing and analysing the
full dataset from the study, with the aim of fully understanding
the results and assessing whether any unexpected confounding
factors have unduly affected the reported outcome. The Company
anticipates it will have completed its review and analysis before
the end of March 2018 and will update the market as soon as
possible thereafter.
Alongside this analysis, the Board has initiated a complete
review of the various strategic options available to the Company,
particularly the options for Feraccru to deliver significant value
to shareholders. The outcome of this strategic review will be
closely linked to the full analysis of the AEGIS-CKD dataset,
subsequent discussions with FDA on the most efficient way to
achieve an approval for Feraccru in the USA and the application to
the EMA to broaden its approved indication in Europe, a decision on
which is still expected during H1 2018.
To maximise the strategic options available to the Company,
Shield has immediately focused on taking positive actions to
preserve cash following the AEGIS-CKD initial topline data readout.
The Board now estimates that the Company has sufficient cash
resources to fund the business until at least the end of Q4 2018.
This is being primarily achieved through a significant reduction in
Shield's own headcount and promotional activities related to
Feraccru, with identification of further cost containment remaining
an ongoing priority. Feraccru will remain commercially available
through Shield Therapeutics, as well as being actively marketed by
and available through, our commercial partners in Scandinavia,
Switzerland and Central Eastern Europe.
Change of results date for the year ended 31 December 2017:
As a result of a change in focus for Shield's finance team since
the AEGIS-CKD initial trial results, the Company will now announce
its results for the year ended 31 December 2017 on 11 April 2018
and not as previously announced on 28 February 2018.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
said: "We remain disappointed by the initial results from the
AEGIS-CKD study, but whilst we seek clarity on what has happened,
it is important that the Company protects its financial resources
and extends its cash runway to maximise the strategic options
available to us. With the commercialisation activities of Feraccru
having gained ground in Germany and the UK, product awareness
growing and evermore patients benefitting from Feraccru therapy,
this is a regrettable but necessary step as it will impact many of
the staff who have helped to build the business and set it up for
the success we anticipated would follow. However, we have no doubt
there is significant value in Shield's assets, not least because of
the frequent positive feedback we continue to receive from
prescribers and patients who use Feraccru. The Board is committed
to ensuring the Company is focused on realising this value on
behalf of its shareholders and will provide further details on
future strategy as soon as it is able."
Other Feraccru pipeline events:
Feraccru in Europe - possible extension of commercial label
In September 2017, Shield submitted an application to the
European Medicines Agency, to broaden the existing commercial label
for Feraccru to include the treatment of all patients with ID,
which has the potential to significantly expand the market
opportunity for Feraccru in Europe. We continue to expect a final
decision from the EMA on this application during the first half of
2018.
Feraccru AEGIS-H2H non-inferiority EU Phase 3b study
The AEGIS-H2H Phase 3b study is designed as a non-inferiority
trial comparing the efficacy and safety of Feraccru to the
market-leading latest generation form of IV iron
(Ferinject/Injectafer, ferric carboxymaltose). Primary endpoint
data from the AEGIS-H2H study is expected to be available in the
second half of 2018.
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Dr Karl Keegan, Chief Financial Officer
Fleur Wood, Director, Investor Relations
Nominated Advisor and Joint Broker +44 (0)203 100 2222
Liberum Capital Limited
Christopher Britton/Steve Pearce
Joint Broker +44 (0)207 418 8900
Peel Hunt LLP
James Steel/ Dr Christopher Golden
Financial PR Advisor +44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
This announcement contains inside information for the purposes
of Article 7 of Regulation 596/2014. The person who arranged for
the release of this announcement on behalf of Shield was Carl
Sterritt, Chief Executive Officer.
About Feraccru(R)
Feraccru is a novel, stable, non-salt, oral formulation of
ferric iron, which has a differentiated mechanism of action
compared to salt-based oral iron therapies. When salt-based oral
iron therapies are ingested, the iron must dissociate from the salt
in the GI tract to allow the iron to be absorbed and treat the IDA.
This free iron readily chelates to form insoluble clumps and
produces damaging free radicals that together cause a range of
mild-to-severe GI adverse events, including nausea, bloating and
constipation, leading to poor tolerability, reduced patient
compliance and ultimately treatment failure. In addition, many
patients with IDA are concurrently treated with medicines that
raise the pH in the gut which further reduces the effect of
salt-based oral iron therapies as they require highly acidic
conditions to be absorbed. Feraccru is not an iron salt, and iron
can be absorbed from the ferric maltol molecule, as a result, it
does not routinely cause the same treatment-limiting intolerance
issues. Feraccru has been shown in clinical trials to be
well-tolerated by patients even when they had previously failed
treatment with salt-based oral iron therapies, which should lead to
increased patient compliance and better patient outcomes.
Currently, the only treatment option for IDA patients who cannot
tolerate salt-based oral iron therapies, is IV iron therapy. IV
iron therapies quickly increase iron stores via direct
administration of very large doses of iron, causing an increase in
Hb levels that is physiologically controlled and occurs over a
period of weeks, as is the case with Feraccru. IV iron therapies,
however, are invasive, costly, inconvenient and complex to
administer, and also come with potentially life-threatening,
spontaneous hypersensitivity reactions.
About Shield Therapeutics plc
Shield is a commercial stage, pharmaceutical company delivering
innovative specialty pharmaceuticals to address patients' unmet
medical needs. Our clear purpose is to help our patients become
people again, by enabling them to enjoy the things that make the
difference in their everyday lives. The Group has a marketed
product, Feraccru(R), for the treatment of IDA in adult patients
with IBD which has exclusive IP rights until the mid-2030's. For
more information please visit www.shieldtherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements. These forward-looking statements are based on
management's current expectations and include statements related to
the timing of future results of Feraccru trials and the timing and
success of the Group's regulatory plans and commercial strategy for
Feraccru. These statements are neither promises nor guarantees, but
involve known and unknown risks and uncertainties, many of which
are beyond our control, that may cause actual results, performance
or achievements to be materially different from management's
expectations expressed or implied by the forward-looking
statements, including, but not limited to, risks associated with
the regulatory approval process, the Group's business and results
of operations, competition and other market factors. The
forward-looking statements made in this press release represent
management's expectations as of the date of this press release, and
except as required by law, the Group disclaims any obligation to
update any forward-looking statements contained in this release,
even if subsequent events cause our views to change.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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