e-Therapeutics plc ("e-Therapeutics" or the "Company") - Interim Results for the Six Months Ended 31 July 2012

  e-Therapeutics plc ("e-Therapeutics" or the "Company") - Interim Results for
  the Six Months Ended 31 July 2012

Business Wire

LONDON -- October 22, 2012

e-Therapeutics plc (AIM: ETX), the drug discovery and development company,
today announces its interim results for the six months ended 31 July 2012.

Highlights

(*Events since the end of the period; **announced today)

Lead cancer drug ETS2101 enters clinic
•  US phase I trial initiated in patients with brain cancer
•   UK phase I trial begins in patients with solid tumours*
•   First data expected Q4 2012; final results from brain cancer trial Q4
    2013 and solid tumour trial Q1 2014**
                                                                             
Focused investment in other development programmes
•   ETS6103 for major depressive disorder: phase IIb trial start expected Q2
    2013; results expected Q2 2014**
•   ETX1153a for MRSA infection: development discontinued**
•   ETX1153c for C. difficile infection: preclinical work progressing
                                                                             
Drug discovery work on track
•   Network Pharmacology Centre opened near Oxford
•   Multiple discovery programmes advancing in oncology and neurology

•   At least one product expected to enter development by end of 2013
                                                                             
Strong balance sheet
    Cash and liquid resources of £11.7 million at 31 July 2012 (31 July
•   2011: £15.3 million; 31 Jan 2012: £13.9 million) providing working
    capital through mid-2014**
•   Half-year net loss of £1.8 million (2011: loss of £1.5 million) reflects
    increased investment in business
                                                                             

Commenting on the Results, Professor Malcolm Young, CEO of e-Therapeutics,
said: “This has been another period of significant progress. In the past six
months we have advanced our most important product, the cancer drug ETS2101,
into two phase I trials. We have also continued to re-shape our drug pipeline,
with a clear determination to focus investment into the most promising assets
in our discovery and development portfolios. We now look forward to some major
clinical milestones and to new outputs from our unique drug discovery platform
in network pharmacology.”

Chairman’s statement

Overview

We are pioneers of a new approach to drug discovery based on network
pharmacology. Our business revolves around monetising drugs resulting from our
discovery programme. Our strategy is to advance the most promising of these
through clinical trials to a point where they can be licensed on attractive
terms to larger companies. We expect this to provide us with revenues in the
form of upfront payments, progress-based milestone payments and royalties on
any sales. During the past six months we have taken our most important product
candidate, the cancer drug ETS2101, forward into two phase I trials. This is a
key step in executing our business plan. We have also continued to build a
broadly based business through work to discover more new drugs at our Network
Pharmacology Centre near Oxford and by selectively advancing other candidates
alongside ETS2101.

Cancer drug enters trials

Our principal objective for 2012 was to move our cancer drug ETS2101 into
clinical trials. The phase I trial programme began in June, when investigators
at the UC San Diego Moores Cancer Center in La Jolla, California, started
enrolling patients with primary or metastatic brain cancer into an
investigator-initiated study. Up to 24 patients will be included in the trial,
which has a dose-escalating design intended to establish a dose for phase II
development, assess safety and tolerability and identify any initial signs of
anti-cancer activity. In September, we started a second phase I trial at two
hospitals in the UK. This will enrol around 45 patients with a variety of
solid tumours. The aims and design of the UK trial are similar to those of the
brain cancer study. First findings from the phase I programme are anticipated
late this year, with further data from both trials available during 2013. We
expect final results from the brain cancer study in Q4 2013 and from the solid
tumour study in Q1 2014.

ETS2101 represents a significant commercial opportunity because of its
potential to address unmet needs in multiple high-value oncology market
segments. An early focus on brain cancers reflects particularly encouraging
preclinical data from brain cancer cell lines and evidence that the drug
crosses the blood-brain barrier, which compromises the effectiveness of many
other cancer drugs in this setting. However, positive findings from other
cancer lines suggest the drug could have wider potential. Our broad phase I
programme is the first step in evaluating which cancer patients might be most
likely to benefit from the product.

Decisions and progress on other candidates

Our second priority in the clinic is to complete a phase IIb trial of ETS6103
in patients with major depressive disorder. We have experienced a delay in the
programme because it took longer than we anticipated to produce tablets that
release the drug over an optimal time period. We now expect to complete a
submission to the UK regulator by the end of this year and to start dosing
patients in Q2 2013. Our phase IIb trial will build on an earlier, small phase
IIa study that produced encouraging results with ETS6103 in comparison with
the approved tricyclic anti-depressant amitriptyline. The forthcoming trial
will compare two doses of ETS6103 with amitriptyline in a randomised protocol
including around 120 patients who have failed prior treatment with an SSRI
anti-depressant. Results are expected in Q2 2014. We regard ETS6103 as a more
modest commercial opportunity than ETS2101 but one that clearly justifies the
limited further investment needed to complete a proof-of-concept trial
designed to demonstrate the product’s value to potential partners.

We have two preclinical programmes targeting infectious diseases. One of
these, ETX1153a, was designed as a topical treatment for MRSA. Final
preclinical tests have reinforced the case that this drug kills a wide range
of MRSA strains at low concentrations and has a good resistance profile, as
predicted by our network pharmacology platform and shown in earlier testing.
However, re-evaluation of development considerations and the commercial
opportunity for the drug has led us to decide that there are better uses of
our resources than pursuing this programme, and it will therefore be
discontinued. Our second anti-infective, ETX1153c, designed for treatment of
C. difficile infection, remains of significant interest. We announced in May
that additional preclinical work was needed to surmount practical issues in
formulating the drug’s two active ingredients in a single tablet. These
ingredients have a synergistic (more than additive) effect against C.
difficile when used in combination. Our preclinical work is ongoing and we
expect to make a decision on whether to advance a candidate into the clinic in
mid-2013.

Discovery – fuelling future growth

At our Network Pharmacology Centre near Oxford, which was opened in February
by UK Prime Minister David Cameron, our scientists are generating a pool of
new drug candidates. We will select the most attractive of these, based on
technical, clinical and commercial criteria, to advance into the clinic. Our
effort is concentrated on complex diseases in which we believe our technology
has particular strengths, principally cancer and nervous system disorders,
although we also have an important research strand in pain. We remain on track
to advance at least one new candidate from discovery into development by the
end of 2013. In addition, we continue to explore opportunities for discovery
collaborations with other companies. Our leading position in network
pharmacology-based drug discovery gained further support in August through the
grant of another European patent.

Strong balance sheet supports investment

Our investment in discovery and development is reflected in an increase in our
first-half net loss to £1.8 million from £1.5 million during the equivalent
period last year. There were no revenues to offset our operating expenses (H1
2012: nil). The income statement shows tax receivable of £0.3 million for the
first half, reflecting our expected receipt of R&D tax credits associated with
qualifying R&D expenditure.

We maintain a strong balance sheet that supports our investment in R&D. At 31
July 2012 we had cash and short-term investments of £11.7 million, compared
with £15.3 million at 31 July 2011 and £13.9 million at 31 January 2012.

The Company’s strategy is to license its products to pharmaceutical companies
for late-stage development and commercialisation. The Company may also enter
discovery collaborations with selected partners. We anticipate continuing
losses until revenues from these sources exceed investment in R&D. Based on
our latest projections, we expect our current funds to support our planned
investment in discovery and development through mid-2014 even in the absence
of any income from partners.

Board enhanced by new appointment

In February we appointed Dr Rajesh Chopra, a senior executive at Celgene
Corporation, as a Non-Executive Director. Raj has brought a wealth of relevant
R&D and clinical experience to our Board.

Outlook

We are now close to reporting our first clinical data since our refinancing in
2011. Initial findings from the cancer programme with ETS2101 will be followed
next year by more extensive data, with final results from the brain cancer
study expected in late 2013 and final results from the solid tumour study
expected in Q1 2014, followed soon afterwards by data from the phase IIb trial
of our antidepressant, ETS6103. Advancing these two drugs rapidly towards
potential partnering deals is our key priority, but we are also very
enthusiastic about applying our unique discovery platform to generate further
new candidates that will fuel long-term growth.

Professor Oliver James

22 October 2012

For the full release, please visit the company website at
www.etherapeutics.co.uk.

Contact:

e-Therapeutics plc
Malcolm Young, CEO
or Daniel Elger, CFO
Tel: +44 (0) 7909 915 068
www.etherapeutics.co.uk

Panmure Gordon (UK) Limited
Fred Walsh
or Hannah Woodley
or Grishma Patel
Tel: +44 (0) 20 7886 2500
www.panmure.com

College Hill
Melanie Toyne Sewell
or Stefanie Bacher
or Rebecca Caygill
Tel: +44 (0) 20 7457 2020
Email: e-therapeutics@collegehill.com

ComStrat Group (US)
Ted Agne
Tel: (+1) 781 631 3117
Email: edagne@comstratgroup.com
 
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