06 December 2017

SUMMIT THERAPEUTICS REPORTS FINANCIAL RESULTS FOR THE THIRD QUARTER AND NINE MONTHS ENDED 31 OCTOBER 2017 AND OPERATIONAL PROGRESS

 

 

Oxford, UK, 6 December 2017 – Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and C. difficile infection (‘CDI’), today reports its financial results for the third quarter and nine months ended 31 October 2017, and reports on operational progress.

“Next year holds the potential to be transformative for our utrophin modulation programme. We remain on track to report during the first quarter of 2018 the 24-week data from PhaseOut DMD, our ongoing Phase 2 clinical trial evaluating our lead utrophin modulator ezutromid. Ezutromid is a potentially disease-modifying treatment for all patients with DMD and we look forward to reporting these initial data from this proof of concept trial. “In this period there has also been continued momentum in the development of our precision CDI antibiotic, ridinilazole. Ridinilazole achieved another positive Phase 2 clinical trial result, further highlighting its potential to both treat the infection and preserve the microbiome to reduce the risk of recurrent disease. The award of a contract worth up to $62 million from BARDA during the period will support in part the Phase 3 clinical and regulatory development of ridinilazole was a major achievement, one which we believe provides important validation of its potential. We are looking forward to initiating the Phase 3 clinical programme for ridinilazole in the first half of 2018 as we seek to bring this urgently needed treatment to patients. “The ongoing support of our shareholders is allowing us to continue to advance these two therapies that have the potential to enhance the quality of life of patients and families living with the burden of DMD and CDI.”

Glyn Edwards

Chief Executive Officer of Summit

Utrophin Modulation Programme: A Universal Treatment for DMD

 

  • PhaseOut DMD is the Phase 2 proof of concept clinical trial that is seeking to establish proof of mechanism for Summit’s lead utrophin modulator ezutromid by evaluating a range of muscle structure, muscle health and functional endpoints. PhaseOut DMD has enrolled a total of 40 patients at sites in the UK and US. Following the 48 weeks of treatment, patients have the option to continue onto an extension phase. The extension phase will be used to gather long term safety and efficacy data and is expected to last until ezutromid either receives marketing approval in the relevant country or its development is discontinued.
  • Completed initial 24 weeks of dosing of ezutromid and remain on-track to report interim 24-week data during Q1 2018 from PhaseOut DMD. These data will include 24-week biopsy results from all patients who provided a 24-week biopsy sample (approximately 20 patients). Summit also expects to report 24-week MRI and functional data from all other patients in the trial. Top-line data from the complete 48-week clinical trial are expected in Q3 2018.
  • Presented a series of posters at the 22nd International Congress of the World Muscle Society that included highlighting validation data of muscle biopsy biomarkers designed to assess utrophin modulator activity in clinical trials. These biomarkers use automated techniques that are capable of analysing thousands of muscle fibres in whole muscle biopsy sections and they have been developed in collaboration with Flagship Biosciences, a leader in quantitative tissue-based biomarkers. These techniques will be used to analyse the biopsy samples in PhaseOut DMD.
  • Publication of preclinical data by scientific adviser and co-founder Professor Kay Davies highlighting the benefits of utrophin modulation on muscle health in preclinical models of disease.  The data showed how continuous expression of utrophin in a dystrophin deficient animal model reduced mitochondrial aberration and oxidative stress, mechanisms that contribute to muscle damage.
  • Joined the Collaborative Trajectory Analysis Project, or cTAP, a community wide coalition in DMD that is developing a natural history database to support clinical trial design and analysis.

 

CDI Programme: Ridinilazole, a Precision Investigational Antibiotic

 

  • Awarded contract from Biomedical Advanced Research and Development Authority (‘BARDA’), worth up to $62 million to support the clinical and regulatory development of ridinilazole for the treatment of CDI. Summit is initially eligible to receive $32 million from BARDA to partially fund activities related to the two planned Phase 3 clinical trials of ridinilazole including initiating enrolment and dosing of patients through to the potential submission of applications for marketing approval. Summit is eligible for further funding of up to $30 million if BARDA exercises in full three option work segments. Summit is continuing to explore various additional funding options for the Phase 3 development programme.
  • Reported positive data from an exploratory Phase 2 clinical trial that supported ridinilazole as a highly selective, precision antibiotic for the treatment of CDI. During the trial’s ten-day treatment period, the microbiomes of ridinilazole-treated patients were markedly preserved as measured by overall bacterial diversity and key changes in bacterial families, when compared to patients treated with fidaxomicin, a marketed narrow-spectrum antibiotic. The primary endpoint of the trial was safety, as measured by the number of treatment emergent adverse events and serious adverse events. During the trial, no new or unexpected safety signals were identified and ridinilazole was generally well-tolerated.

 

Operational Highlights

 

  • Held successful R&D Day for investors and analysts in New York City in October 2017. The event reviewed the DMD and CDI programmes and included presentations from key opinion leaders in both fields of research. A webcast of the event is available on Summit’s website.

 

Financial Highlights

 

  • Public offering of 1,677,850 American Depositary Shares (‘ADS’), representing 8,389,250 ordinary shares of one penny nominal value, with new and existing institutional investors, and raised gross proceeds of $20.1 million (£14.9 million). The public offering, including the underwriters exercise in full of their over-allotment option, closed in September 2017.
  • Cash and cash equivalents at 31 October 2017 of £31.8 million compared to £28.1 million at 31 January 2017.
  • Profit for the nine months ended 31 October 2017 of £4.4 million compared to a loss of £16.4 million for the nine months ended 31 October 2016 reflecting receipt and recognition of a $22.0 million (£17.2 million) development milestone payment received from Sarepta Therapeutics Inc. (‘Sarepta’) in June 2017.

 

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).

 

About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programmes focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

 


 

For more information, please contact:

 

Summit

 

 

Glyn Edwards / Richard Pye (UK office)

Tel:

44 (0)1235 443 951

Erik Ostrowski / Michelle Avery (US office)

 

+1 617 225 4455

 

 

 

Cairn Financial Advisers LLP (Nominated Adviser)

Tel:

+44 (0)20 7213 0880

Liam Murray / Tony Rawlinson

 

 

 

 

 

N+1 Singer (Joint Broker)

Tel:

+44 (0)20 7496 3000

Aubrey Powell / Jen Boorer

 

 

 

 

 

Panmure Gordon (Joint Broker)

Tel:

+44 (0)20 7886 2500

Freddy Crossley, Corporate Finance

 

 

Tom Salvesen, Corporate Broking

 

 

 

 

 

MacDougall Biomedical Communications (US)

Tel:

+1 781 235 3060

Karen Sharma

 

ksharma@macbiocom.com

 

 

 

Consilium Strategic Communications (UK)

Tel:

+44 (0)20 3709 5700

Mary-Jane Elliott / Jessica Hodgson /

 

summit@consilium-comms.com

Philippa Gardner/ Rosie Phillips

 

 

 

 

 

Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about the development and potential commercialisation of our product candidates, the therapeutic potential of our product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential benefits and future operation of the collaboration with Sarepta including any potential future payments thereunder, the potential benefits and future operation of the BARDA contract including any potential future payments thereunder, any other potential third-party collaborations and expectations regarding the sufficiency of our cash balance to fund operating expenses and capital expenditures, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the ability of BARDA to terminate its contract with us for convenience at any time,  expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that we make with the Securities and Exchange Commission, including our Annual Report on Form 20-F for the fiscal year ended 31 January 2017. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release


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