Summit Release AGM Statement

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July 03, 2014 04:00 ET

Summit Therapeutics plc

Summit Therapeutics plc

Summit Corporation plc

('Summit' or the 'Company')

ANNUAL GENERAL MEETING STATEMENT

Oxford, UK, 3 July 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), is today holding its Annual General Meeting at 10:00am at the Milton Park Innovation Centre, 99 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY.  During the meeting the Company's Chief Executive Officer, Glyn Edwards, will make the following statement while a short presentation will be made providing an overview of the Company's two clinical programmes.  This presentation will be available for download post the meeting from Summit's website, www.summitplc.com.

"The last year has been a period of significant progress by your Company.  Our two clinical programmes developing treatments for DMD and CDI have advanced into patient clinical trials, while the financial resources needed to support our clinical development plans were substantially enhanced after new funds were secured from a range of sources.

"In our utrophin modulator programme for the treatment of DMD, the most common and severest form of muscular dystrophy, our lead candidate SMT C1100 completed the first ever patient trial of a utrophin drug.  The top-line results from this non-placebo controlled trial were reported in May 2014 and showed SMT C1100 was safe and well tolerated, and reduced creatine kinase levels, an enzyme typically associated with muscle damage.  In addition, variable uptake of the drug was observed with initial evidence suggesting this may be related to differences in diet and to other disease related-factors.  Further evaluation of the data from this Phase 1b is on-going and we look forward to making further announcements as well as presenting our findings at future scientific conferences.

"As part of our wider commitment to utrophin modulation as a treatment approach for all patients with DMD, Summit expanded its next generation utrophin modulator programme through the formation of a strategic alliance with the University of Oxford.  The research from this alliance will supplement our existing pipeline of next generation modulators and should help to ensure that Summit has a long-term pipeline of utrophin related drugs.  To further raise awareness of utrophin as a treatment approach, this collaboration has been given a unique identity, the UtroDMD Alliance, as we work in partnership to advance utrophin drugs.

"Our second independent programme is developing SMT19969, a novel, oral small molecule antibiotic in development specifically for the treatment of infections caused by the bacteria Clostridium difficile.  This infectious disease poses a serious healthcare effect with existing treatments failing to address the key clinical issue of disease recurrence rates which can be as high as 30% and which reflects the urgent need to develop new antibiotics.

"SMT19969 achieved an important development milestone during the period when it successfully completed a Phase 1 clinical trial in healthy volunteers.  In this study the antibiotic was safe and well tolerated at all doses tested, while the impact on the natural balance of the gut flora was also measured.  The results show SMT19969 was highly sparing of the normal gut flora of the volunteers, with only the clostridia bacterial family being reduced to levels below detection.  This data is highly encouraging for future efficacy trials.  A Phase 2 proof of concept trial in North America is now underway and we announced separately this morning that the first patients have been enrolled and dosed.

"The ability of Summit to support financially the development of these two promising programmes was enhanced through the securing of funding from a number of sources.  In the last 12 months, the Company completed two financings to raise a total of £26.6m before expenses.  These financings were supported by existing investors and also attracted new specialist healthcare institutions based in the US and Europe.  Our two programmes also received funding from a number of additional sources including the UK Government's Biomedical Catalyst scheme, the Wellcome Trust and various charitable DMD foundations.

"The Company has also recently appointed a new Chief Financial Officer, Erik Ostrowski, who brings a broad range of skills and expertise in strategic, financial and operational matters to supplement the quality of our management team.  Erik is based in Cambridge, Massachusetts where Summit recently established operations to provide greater interaction with academic, clinical and business leaders in our areas of therapeutic development.

"In conclusion, the Company is entering an exciting period of development as our two clinical programmes continue to progress through patient trials that seek to add value to these potential treatments for life threatening conditions.  On behalf of the Board, I thank all shareholders for their continuing support and look forward to updating you on our future progress."

Summit is an Oxford, UK based drug discovery and development company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection.  Summit is quoted on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

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Forward Looking Statements

This announcement contains "forward-looking statements", including, but not limited to, statements about the discovery, development and commercialisation of programme assets. These forward-looking statements are statements based on the Company's current intentions, beliefs and expectations, which include, among other things, the Company's results of operations, financial condition, prospects, growth, strategies and the industry in which the Company operates. No forward-looking statement is a guarantee of future performance and actual results could differ materially from those expressed or implied in the forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements or information.  Forward-looking statements and information by their nature involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. These include but are not limited to: adverse results in clinical or preclinical development studies; delays in obtaining regulatory approval; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; being unable to secure partnership agreements to develop and commercialise programme assets; being unable to secure the necessary funding to conduct any proposed research and development studies; and the ability to retain and recruit key personnel.  The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this announcement to reflect any changes in expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based, except as required by applicable law.