UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2015
Commission File Number 001-36866
SUMMIT
THERAPEUTICS PLC
(Translation of registrants name into English)
85b Park Drive
Milton
Park, Abingdon
Oxfordshire OX14 4RY
United Kingdom
(Address
of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
FORM
20-F x FORM 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T
Rule 101(b)(7): ¨
Indicate by check mark whether the registrant by furnishing the information
contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
YES ¨ NO
x
If Yes is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
On November 17, 2015, Summit Therapeutics plc (the Company) issued a press release announcing a
multi-year extension of its exclusive strategic alliance with the University of Oxford until November 2019, with an option to extend it for another 12 months. The related press release is attached hereto as Exhibit 99.1.
On November 20, 2015, the Company issued a press release announcing that, pursuant to Rule 17 of the AIM Rules for Companies, David Wurzer, a
Non-Executive Director of the Company, resigned from his directorship at Response Genetics, Inc. (Response Genetics), following Response Genetics entry into an agreement to sell its assets out of Chapter 11 bankruptcy protection.
The related press release is attached hereto as Exhibit 99.2.
The information contained in Exhibit 99.1 and Exhibit 99.2 shall not be deemed
filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except
as expressly set forth by specific reference in such a filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
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SUMMIT THERAPEUTICS PLC |
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By: |
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/s/ Erik Ostrowski |
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Erik Ostrowski |
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Chief Financial Officer |
Date: November 20, 2015
EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Press Release dated November 17, 2015 |
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99.2 |
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Press Release dated November 20, 2015 |
Exhibit 99.1
Summit Therapeutics plc
(Summit or the Company)
SUMMIT
THERAPEUTICS AND THE UNIVERSITY OF OXFORD ANNOUNCE MULTI-YEAR EXTENSION OF STRATEGIC ALLIANCE FOR DEVELOPMENT OF UTROPHIN MODULATORS FOR DMD
Oxford, UK, 17 November 2015 Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing
therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection, announces a multi-year extension of its exclusive strategic alliance with the University of Oxford until November 2019, with an option to extend
it for a further 12 months, to support and accelerate development of future generation utrophin modulators for the treatment of the progressive muscle wasting disorder, DMD.
Utrophin modulation is a therapeutic approach that has the potential to slow or even stop the progression of DMD in all patients with this genetic
disorder. DMD is caused by the absence of functional dystrophin protein and utrophin is a naturally occurring protein that is functionally similar to dystrophin. Utrophin modulation aims to maintain the production of utrophin to compensate
for the missing dystrophin.
Summits strategic alliance with the University of Oxford is an important part of our DMD programme that seeks
to discover and develop a strong pipeline of utrophin-based therapies for the treatment of all patients with DMD behind our lead clinical candidate SMT C1100, commented Glyn Edwards, Chief Executive Officer of Summit.
This is an incredibly exciting time for the field of utrophin modulation with SMT C1100 poised to enter a Phase 2 proof of concept trial and the recent publication of positive preclinical efficacy data on our second generation candidates.
The extension of our alliance will allow us to invest further in utrophin modulation in partnership with the world-leading academic research groups at Oxford. This will help to accelerate the development of future generation molecules towards
clinical trials, as we seek to maintain our leadership position in this field and potentially allow DMD boys to live longer and more fulfilled lives.
The strategic alliance is a collaboration between Summit and the research teams of Professor Kay Davies, an internationally acclaimed expert in DMD at the
University of Oxford, Professor Stephen Davies, Waynflete Professor of Chemistry at the University of Oxford and a director of Summit, and Professor Angela Russell, an expert in medicinal chemistry and pharmacology at the University of Oxford. To
date, the collaboration has identified a number of new series of utrophin modulator compounds that are structurally distinct from the clinical candidate SMT C1100. Work is on-going towards selection of one or more of these differentiated series for
progression into lead optimisation studies.
Linda Naylor, Managing Director of Isis Innovation, the University of Oxfords technology
commercialisation company, said, This is great progress from our committed commercial partners who are applying this important Oxford research with the potential to impact many lives for the better.
Terms of the Alliance Extension
Under the terms of the
alliance extension, Summit retains an exclusive option to arising intellectual property (IP) in the field of utrophin modulation generated during the term of the collaboration. Summit will also continue to sponsor a drug discovery and
development programme in the University of Oxford research laboratories to identify and develop oral utrophin modulators for the treatment of DMD. This research programme, originally running to November 2016, will now continue until November 2019
with an option to extend it for a further 12 months. As part of the extension, Summit will increase the funding to £0.83 million a year starting in November 2015. Isis Innovation Limited (Isis) continues to hold warrants over
354,090 ordinary shares that were granted as part of the original alliance agreement signed in 2013. All the warrants may be exercised by Isis by February 2020, three months after the end of the alliance extension, subject to achieving key research,
development and regulatory milestones.
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around 50,000 boys in the developed world. The disease is caused by different genetic faults in the
gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to
dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle integrity and performance. Utrophin modulation has the potential to slow down or even stop the progression of DMD, regardless of the
underlying dystrophin mutation. It is also expected that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. Summits most advanced utrophin modulator is the oral small molecule SMT C1100, which it is
preparing to enter a Phase 2 proof of concept trial. DMD is an orphan disease, and the US Food and Drug Administration and the European Medicines Agency have granted orphan drug status to SMT C1100. Orphan drugs receive a number of benefits
including additional regulatory support and a period of market exclusivity following approval.
About Isis Innovation
Isis is the research and technology commercialisation company of the University of Oxford. It provides access to technology from Oxford researchers through
intellectual property licensing, spin-out company formation and material sales, and to academic expertise through Oxford University Consulting. Isis is the highest university patent filer in the UK and is ranked 1st in the UK for university spin-outs, having created over 110 new companies in 25 years. In the last financial year it completed 529 licenses and consulting agreements. Isis Enterprise, its innovation
management consultancy, works with university, government and industrial clients from offices around the world.
Isis was named Technology Transfer
Unit of the Year 2014 by Global University Venturing and in 2015 Isis Enterprise was awarded a Queens Award for Enterprise (International Trade). For updates on innovations from Oxford, follow Isis on LinkedIn and
Twitter or subscribe at www.isis-innovation.com
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 programs focused on the genetic disease DMD and the infectious disease Clostridium difficile infection. Further information is available at www.summitplc.com and Summit can be
followed on Twitter (@summitplc).
For more information, please contact:
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Summit Glyn Edwards / Richard Pye (UK
office) Erik Ostrowski / Michelle Avery (US office) |
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Tel: +44 (0)1235 443 951
+1 617 225 4455 |
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Cairn Financial Advisers LLP (Nominated
Adviser) Liam Murray / Tony Rawlinson |
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Tel: +44 (0)20 77148 7900 |
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N+1 Singer (Broker)
Aubrey Powell / Jen Boorer |
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Tel: +44 (0)20 7496 3000 |
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Peckwater PR (Financial public
relations, UK) Tarquin Edwards |
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Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk |
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MacDougall Biomedical Communications (US
media contact) Chris Erdman |
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Tel: +1 781 235 3060
cerdman@macbiocom.com |
Forward-looking Statements
Any statements in this press release about Summits future expectations, plans and prospects, including but not limited to, statements about the clinical
and preclinical development of Summits product candidates, the therapeutic potential of Summits product candidates, and the timing of initiation, completion and availability of data from clinical trials, 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 on-going 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 or preclinical studies will be indicative of the
results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summits foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the
Risk Factors section of filings that Summit makes with the Securities and Exchange Commission including Summits Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue
reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summits views only as of the date of this release and should not be relied upon as representing
Summits views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.
-END-
Exhibit 99.2
Summit Therapeutics plc
(Summit or the Company)
DIRECTOR
DECLARATION
Oxford, UK, 20 November 2015 Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development
company advancing therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection, announces pursuant to Rule 17 of the AIM Rules for Companies (the AIM Rules), the following change to a
Directors disclosure under Schedule Two, paragraph (g) of the AIM Rules:
David Wurzer, Non-Executive Director, has resigned from his
directorship at Response Genetics, Inc. (Response Genetics), following Response Genetics entering into an agreement to sell its assets out of Chapter 11 bankruptcy protection.
Save as disclosed above, there is no further information to be disclosed under the AIM Rules.
For more information, please contact:
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Summit Glyn Edwards / Richard Pye (UK
office) Erik Ostrowski / Michelle Avery (US office) |
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Tel: +44 (0)1235 443 951
+1 617 225 4455 |
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Cairn Financial Advisers LLP (Nominated
Adviser) Liam Murray / Tony Rawlinson |
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Tel: +44 (0)20 77148 7900 |
-END-
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