E-therapeutics Regulatory News (ETX)

e-Therapeutics plc

("e-Therapeutics" or the "Company")

Half year trading and commercial strategy update

Oxford and Newcastle, UK, 17 August 2015 - e-Therapeutics plc (AIM: ETX), the drug discovery and development company today provides a trading update for the six month period to 31 July 2015 and further information on its commercial strategy.

Discovery platform productivity

The productivity of e-Therapeutics' discovery platform continues to exceed our expectations. During H1, we commenced four new projects and currently have ten active projects in preclinical discovery. To date we have identified more than 500 molecules with high specific bioactivity across seven discovery projects, including many molecules that are the most potent known. We believe that the productivity of our drug discovery function is currently world leading in terms of yield, potency, selectivity and time/cost.

Commercial focus

Having demonstrated high productivity and agility in the discovery platform, the Company is now able to focus its discovery activities into areas of high and immediate commercial demand. Accordingly, we have initiated discovery activities in cancer immunotherapy, in which area almost all large companies are presently strongly interested. The first such immunotherapy project is focussed on IDO1 and TDO2, well-studied targets in relation to modulating immune system action in cancer. Other immune-oncology projects are beginning.

Similarly, many "targeted" cancer therapies suffer from marked therapeutic resistance, in which cancer cells rapidly evolve resistance to the "targeted" drug, allowing the cancer to come back. Products that can rescue these otherwise valuable targeted drugs from therapeutic resistance represent a high, immediate and focussed commercial opportunity. The first such 'drug rescue' project addresses resistance to Hedgehog3 pathway agents that target "SMO" 4. Our lead molecules show potency in the nanomolar range through targeting the Hedgehog pathway without binding SMO. Other targeted therapeutic resistance projects are beginning. 

We remain pleased with the preclinical progress of the active projects. As previously stated, the aim is to have analysed a substantial number of discovery projects by the end of the current financial year and for the most promising compounds to enter pre-IND development by the end of H1 2016. We remain confident that this target will be achieved. The intent remains that the most promising of these candidates will be ready to enter clinical development or out-licensing in 2017. 

Development progress

Drug development recruitment has progressed in line with our expectations. ETS6103, aimed at major depressive disorder that is refractory or relapsing from first-line SSRI5 treatment, has completed the recruitment of the final patient into the randomised double blind controlled phase IIb study. We anticipate being able to un-blind the trial data at the end of the current financial year. Once reviewed, we will announce the findings. If the results are positive we will seek to out-license the drug.

The US phase Ia trial for ETS2101, looking at brain cancer, has recruited the final patient and we will report on this in a separate announcement once all the data has been reviewed. We previously announced that on 19 May 2015 the first patient received the initial dose in the phase Ib trial for ETS2101. This Ib trial is designed to investigate ETS2101 in combination with the standard of care for patients with newly diagnosed hepatocellular carcinoma (HCC) or pancreatic cancer, or as a monotherapy in patients with primary HCC or Pancreatic cancer who have relapsed or refractory disease. To date we have recruited three HCC and eight Pancreatic cancer patients for these trials with a number more in screening. Most recently, we have received rapid approval from the US FDA for an application to extend our phase Ib trials for ETS2101 in the USA. We aim to provide an initial update on the phase Ib activities towards the end of the financial year.

Summary

Professor Malcolm Young, CEO, said, "The Board is greatly encouraged by the group's performance in the first six months of the year. The discovery platform continues to identify a large number of highly active molecules, indeed molecules with world-leading potency in some cases, and the progress of all discovery and clinical development projects are in line with our expectations. In addition, we have recently appointed external consultants to aid strengthening our Board, including appointing a non-executive chairman, as we move into a much more commercially focussed period in the Company's development.

"e-Therapeutics remains well financed, with a cash balance at the half year end of around £30 million having received a £2m R&D tax credit in the period. The Company will provide a more complete update on the first half performance and ongoing activities at the time of the interim results, which are scheduled for the end of September."

-Ends-

Notes:

1. Indoleamine 2,3-dioxygenase. IDO is an immune checkpoint molecule, sometimes exploited by tumours to diminish immune response to cancer.

2. Tryptophan 2,3-dioxygenase. TDO can be exploited by tumours to dampen the antitumor immune response.

3. The Hedgehog pathway is an important development pathway involved in patterning and cell fate, which is frequently reactivated in tumour cells.

4. Smoothened (SMO) is a G protein-coupled receptor that is a component of the hedgehog signaling pathway. It is conserved from flies to humans, and is the intended principal binding target of both vismodegib (Erivedge, Genentech Inc) and sonidegib (Odomzo, Novartis).

5. Selective serotonin re-uptake inhibitors, a class of compounds which are widely prescribed as antidepressants

Contacts:

e-Therapeutics plc

Malcolm Young, CEO / Steve Medlicott, Finance Director

Tel: +44 (0)1993 883 125

www.etherapeutics.co.uk

N+1 Singer

Aubrey Powell / Jen Boorer

Tel: +44 (0) 20 7496 3000

www.n1singer.com

Instinctif Partners

Melanie Toyne Sewell / Jayne Crook

Tel: +44 (0) 20 7457 2020

Email: e-therapeutics@instinctif.com

About e-Therapeutics plc

e-Therapeutics is a drug discovery and development company with a proprietary platform in network pharmacology, an innovative approach to drug discovery based on advances in network science and chemical biology. e-Therapeutics' platform is generating more potent, selective and diverse molecules at much higher yields than is reported for conventional drug discovery. The Company's discovery and development activity addresses age-related diseases, including cancer and central nervous system disorders, and it is fully funded to advance its programme into 2019, including phase II clinical data and multiple regulatory submissions.

e-Therapeutics has a phase IIb clinical stage drug candidate for major depressive disorder, ETS6103. It has a phase Ib clinical stage candidate in hepatocellular and pancreatic cancer, ETS2101. The company has a variety of preclinical stage assets, including ETX1153c, a functionally resistance-less antibiotic; ETS2300, potent telomerase inhibition in anti-cancer; ETS3100, potent small molecule anti-TNFα; ETS2400, potent Hedgehog pathway inhibition; and ETS6200, in neuroprotection.

e-Therapeutics is based at sites in Oxford and Newcastle, UK. For more information about the Company, please visit www.etherapeutics.co.uk.