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14 May 2013 – e-Therapeutics plc (“e-Therapeutics”; AIM: ETX), the drug discovery and development company, today announces its preliminary results for the year ended 31 January 2013.
Highlights of 2012/13
(* = events after the 31 January 2013 year end; **announced today)
Lead cancer drug ETS2101 enters clinic
• US phase I trial started in patients with brain cancer
• UK phase I trial begun in patients with solid tumours
• First findings reported from phase I programme**
• Key phase I results expected in Q4 2013 (brain cancer) and Q1 2014 (solid tumours)
Pipeline refined and advanced
• ETS6103: application filed with UK regulator for phase IIb trial in major depressive disorder**
• ETX1153a for MRSA infection: preclinical development discontinued
• ETX1153c for C. difficile infection: preclinical work progressing
Major focus on drug discovery
• Network Pharmacology Centre opened near Oxford
• Multiple discovery programmes advancing in oncology and central nervous system disorders
• Further strengthening of platform approach and intellectual property position
• New candidate expected to progress to development by end of 2013
Significant equity raise supports growth plans*
• Year-end cash and liquid resources of £9.8 million (31 January 2012: £13.9 million) boosted to £48 million pro-forma following equity placing in March 2013*
• Post-placing cash sufficient to fund business into calendar 2017, complete key efficacy trials of ETS2101 and broaden portfolio through new drug discovery programmes*
• Full-year net loss of £4.2 million (2012: loss of £3.2 million) reflects increasing investment in drug discovery and development programmes
Commenting on the results, Professor Malcolm Young, CEO of e-Therapeutics, said: “We have growing momentum in the key areas of our business. Use of our innovative network pharmacology platform to discover new drugs is on track while our most significant product candidate, the cancer drug ETS2101, is making good progress in the clinic.”
Dr Daniel Elger, CFO of e-Therapeutics, added: “We are increasing investment in R&D as we seek to make the most of the opportunities in our platform and pipeline. Our recent £40 million fundraising leaves us even better placed to pursue our goals, with a cash runway that now extends to a potential partnering deal for our lead cancer drug and resources sufficient to generate a diversified portfolio of assets over the next 3-4 years.”
For more information, please contact:
Malcolm Young, CEO / Daniel Elger, CFO
Tel: +44 (0) 7909 915 068
Panmure Gordon (UK) Limited
Fred Walsh / Hannah Woodley / Grishma Patel
Tel: +44 (0) 20 7886 2500
Melanie Toyne Sewell / Stefanie Bacher / Rebecca Caygill / Donia Al Saffar
Tel: +44 (0) 20 7457 2020
ComStrat Group (US)
Tel: (+1) 781 631 3117
Our business is built around a distinctive new approach to the discovery of medicines called network pharmacology. We have formulated this approach as a patented platform technology, which we are using to seek novel treatments for cancer and disorders of the nervous system. Our strategy is to take promising drug candidates from discovery through clinical trials to a point when they can be licensed on attractive terms to larger companies. We expect this to provide revenues in the form of upfront payments, progress-based milestone payments and royalties on any sales. During the year we advanced our most important candidate, the cancer drug ETS2101, into two phase I trials. We also continued to build a broad portfolio through work to discover more new drugs at our Network Pharmacology Centre near Oxford and by selectively advancing other candidates alongside ETS2101. Since the year end, we have raised significant additional capital to further our drug discovery and development plans.
Cancer drug enters trials
Our top priority in 2012 was to move our cancer drug ETS2101 into clinical trials. Accordingly, we initiated two phase I studies during the period: an investigator-led trial in brain cancer, which is taking place at the UC San Diego Moores Cancer Center in La Jolla, California, and a company-sponsored study that is enrolling patients with a variety of solid tumours at hospitals in Newcastle and Leeds, UK. Both trials have a dose-escalating design, in which successive groups of patients receive increasing doses of ETS2101. The aim is to establish an appropriate dose for phase II development, assess safety and tolerability and identify any initial signs of anti-cancer activity.
In December we announced that the two trials had enrolled a total of 12 patients at relatively low dose levels and that no serious drug-related adverse events had been observed. Since then, more patients have been treated with higher doses of ETS2101. The additional patients have all been in the UK because recruitment paused for a time in the US pending approval of a protocol amendment. Eleven patients have now been treated in the UK trial. No serious adverse events have been attributed to ETS2101, although one patient had severe fatigue after receiving the drug and continued treatment at a lower dose. A patient with oesophageal cancer has experienced a partial response according to RECIST, a standard method for assessing the impact of treatments on tumour burden (see Notes below). Both the UK and US studies continue to recruit patients and we expect key data from the brain cancer trial in Q4 2013 and from the solid tumour trial in Q1 2014.
ETS2101 represents a significant commercial opportunity because it could address unmet needs in multiple high-value oncology market segments. If key data on dosing and safety from the phase I programme are supportive we intend to advance the drug rapidly into the next phase of its clinical development. We expect this to include a randomised phase II trial in brain cancer (glioma) and a phase Ib/II trial that will explore the drug’s activity in four to six other cancer indications. We indicated with the announcement of our share placing in February 2013 that we expect to spend around £25 million on completion of phase I trials and the efficacy trials that follow, with the intention to finish the studies in time to conclude a licensing deal or deals during 2017 if the data are positive.
Pipeline continues to evolve
We announce today that we have filed a Clinical Trial Application (“CTA”) with the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) for a phase IIb trial of ETS6103 in major depressive disorder. We anticipate that we will start enrolling patients at or around the end of Q2 2013. The 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. It will include more patients and a longer period of treatment than we had originally planned, so we now expect to report results in the second half of 2014. We regard ETS6103 as a smaller commercial opportunity than ETS2101 but one that justifies the limited further investment needed to complete a proof-of-concept trial designed to demonstrate the product’s value to potential partners.
In May we announced that we would perform further preclinical work with our drug for the treatment of C. difficile infection, ETX1153c, before taking a decision on whether it should progress into clinical trials. This work is nearing completion, and we expect to make a go/no-go decision on the programme in Q3 2013. In October, we decided to cease development of our preclinical anti-MRSA drug ETX1153a because we considered other programmes likely to provide a better return on investment.
Discovery – fuelling future growth
Our new drug discovery hub near Oxford was opened in February 2012 by the UK’s Prime Minister, David Cameron. Scientists there are generating a pool of new drug candidates, from which we will select the best to advance into the clinic based on technical, clinical and commercial criteria. Work is concentrated in complex diseases in which we believe our technology has particular strengths, principally cancer and nervous system disorders. We remain on track to advance a new candidate from discovery into development by the end of 2013.
We continue to invest in improvements to our discovery platform and to gain additional intellectual property protection for our approach; we were granted further patents in the US and Europe during the period. We also remain active in exploring opportunities to collaborate with other companies on discovery programmes.
Strong balance sheet supports investment
Increasing investment in discovery and development drove an increase in our operating expenses from £4.0 million last year to £5.2 million for the year ended 31 January 2013. We had no revenues in the period (2012: nil), but recognition of R&D tax credits of £0.8 million (2012: £0.6 million) and net interest income of £0.2 million (2012: £0.2 million) reduced our net loss to £4.2 million (2012: £3.2 million).
At 31 January 2013 we had cash and short-term investments of £9.8 million (31 January 2012: £13.9 million). These resources were expanded significantly by a share placing to existing and new investors in March 2013; this raised £40.0 million (£38.8 million net of expenses) through the issue of 125 million new shares at 32p per share, leaving the Company with pro-forma cash and short-term investments of approximately £48 million on the close of the transaction.
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. Following our recent placing, we expect to be able to support our discovery and development plans into calendar 2017 even in the absence of any income from partners. Over that period we plan to complete mid-stage trials of our lead cancer drug ETS2101 and conclude a licensing deal for the product if the data are supportive. We also expect to add newly discovered candidates to our pipeline and advance a number of these through preclinical and early clinical development, giving us a broader portfolio in which risk is diversified and there are multiple sources of potential upside.
Board enhanced by new appointment
In February 2012 we appointed Dr Rajesh Chopra, a senior executive at Celgene Corporation, as a Non-Executive Director. Dr Chopra is bringing a great deal of relevant R&D and clinical experience to our Board.
We look forward to reporting key results from our phase I trials of ETS2101 over the next year. We have clear plans in place to take this drug rapidly into efficacy trials if data continue to be supportive, and following our recent share placing we have the resources on hand to do this. In the meantime, during the remainder of this year we expect progress announcements on other clinical and preclinical candidates and to adopt the first of a new wave of candidates from our discovery work into formal development, an important landmark following the renewal of investment in our network pharmacology platform that began in 2011.
Professor Oliver James
14 May 2013
About the RECIST criteria used to assess tumour responses
RECIST (Response Evaluation Criteria in Solid Tumours) provide a standardised way of assessing the response of solid tumours to treatment. Under the criteria, a partial response is recorded when the linear dimensions of the tumour lesions selected for measurement at the start of the study reduce by at least 30% from baseline and no new lesions appear.
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