SMMT Summit Therapeutics Inc

 

 

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 July 2015

Commission File Number 001-36866

 

 

SUMMIT THERAPEUTICS PLC

(Translation of registrant’s 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):

 

 

 

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On July 14, 2015, Summit Therapeutics plc (the “Company”) held its Annual General Meeting of shareholders (“AGM”). At the AGM, the Company’s Chief Executive Officer, Glyn Edwards, made a statement providing operational and other highlights of the completed fiscal year. Only July 14, 2015, the Company issued a press release regarding Mr. Edwards’ statement, a copy of which is attached hereto as Exhibit 99.1.

On July 14, 2015, the Company issued a press release announcing the results of the AGM. This press release is attached hereto as Exhibit 99.2

The information contained in Exhibits 99.1 and 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.

 

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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.

 

Date: July 16, 2015

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Press Release dated July 14, 2015 regarding Annual General Meeting Statement
99.2		Press Release dated July 14, 2015 announcing results of Annual General Meeting

EXHIBIT 99.1

 

 

Summit Therapeutics plc

(“Summit” or the “Company”)

ANNUAL GENERAL MEETING STATEMENT

Oxford, UK, 14 July 2015 – 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’), is today holding its Annual General Meeting at 1:30pm BST / 8:30am EDT at the offices of Fasken Martineau, 17 Hanover Square, London, W1S 1HU. During the meeting, the Company’s Chief Executive Officer, Glyn Edwards, will make a statement, a copy of which is below.

Summit will webcast the Annual General Meeting from 1:30pm BST / 8:30am EST. To participate in the conference call please dial +44 (0)20 3147 4971 (UK and international participants) or +1 212 444 0412 (US participants) and use the conference confirmation code 5910227. Investors may also access a live audio webcast of the call via the investors section of the Company’s website www.summitplc.com.

Chief Executive’s Statement

“The last 12 months have been a time of substantial progress. We have seen our lead product candidates advance into clinical trials in patients, expanded our operations into the United States, and have also received strong financial backing from investors highlighted by the successful NASDAQ initial public offering. The Company is now entering a data rich period as we approach key clinical milestones in our two programmes for the treatment of DMD and C. difficile infection respectively.

“Our utrophin modulation programme for the treatment of Duchenne Muscular dystrophy, or DMD, seeks to treat all patients with this devastating muscle wasting disease. Utrophin modulation is a scientific approach that has the potential to slow or even stop the progression of DMD and would be applicable to all patients with DMD, regardless of the underlying genetic faults. We believe also that it could be complementary to other disease modifying approaches in development that only treat smaller sub-sets of the patient population.

“We are developing a pipeline of utrophin modulator drugs as we seek to capitalise on our established leadership position in this field of research. Our lead utrophin modulator is SMT C1100, which has completed a Phase 1b clinical trial. We believe this trial was the first time a utrophin modulator drug was administered to DMD patients. The Phase 1b achieved its primary endpoint with SMT C1100 being well tolerated at all doses tested. In addition, there was an excellent rate of patient compliance.

“While the trial was not placebo controlled, the data reported were encouraging as after the ten days of dosing, a reduction was observed in levels of three enzymes that are biomarkers of muscle damage in patients with DMD. The enzymes were CK, AST and ALT, and typically the levels of these enzymes are low in people who do not have DMD, but are elevated in patients with DMD, as the disease weakens muscle cells, and the enzymes leak out and accumulate in the blood. We believe that SMT C1100 activity is one potential explanation for the lower levels of these enzymes.

“These encouraging data on SMT C1100 were achieved with levels of drug uptake into the blood plasma of patients that we believe can be improved upon. In our Phase 1 healthy volunteer trial in 2012, higher blood plasma levels of SMT C1100 were achieved when the drug was taken with food. In our completed Phase 1b trial, the patients took SMT C1100 with food but there was still variability between the patients, with the majority having plasma levels that were similar to those of fasted healthy volunteers in our Phase I trial.

“Our on-going Phase 1b modified diet trial being conducted in patients with DMD aims to increase the plasma levels of SMT C1100 compared to those observed in our previous Phase 1b trial by providing patients with specific dietary guidance recommending balanced proportions of fat, proteins and carbohydrates. We believe such a diet has the potential to increase the uptake of SMT C1100 into the blood plasma.

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“The primary objective of this trial is to see an increase in the number of boys achieving the target plasma level beyond the two out of 12 figure that was reported from our previous Phase 1b trial. If a reduction in the enzyme biomarkers is observed in the treatment groups compared to placebo, this is also expected to lead to the progression of SMT C1100 into Phase 2 clinical trials.

“With the Phase 1b modified diet trial fully enrolled, we look forward to reporting top-line data from this trial before the end of September 2015.

“We are also working with leading formulation companies to develop in parallel new optimised formulations of SMT C1100. The new formulations are showing promising improvements in preclinical studies, and we intend to advance one or more of the new formulations into clinical trials later this year.

“Once we have achieved adequate exposure of SMT C1100 in patients with DMD, we expect to initiate during the second half of 2015 a Phase 2 open label trial in DMD patients designed to evaluate the longer-term effects of SMT C1100 on muscle health, function and safety. We also plan to initiate a larger placebo controlled Phase 2 trial that is expected to include sites in the United States and Europe.

“In addition, our collaboration with the teams at the University of Oxford have seen great progress with new utrophin modulators and results have been presented at conferences and published in the peer reviewed scientific literature. We believe that these collaborations have the potential to lead to the identification of new generations of utrophin modulators with improved pharmaceutical properties and new utrophin related mechanisms to expand our pipeline.

“Our second programme is developing a novel antibiotic called SMT19969 for the treatment of infections caused by the bacteria Clostridium difficile. SMT19969 is a novel class of antibiotic and is designed to selectively target C. difficile bacteria without causing collateral damage to the natural gut flora and thus has the potential to reduce CDI disease recurrence which is the key clinical issue.

“In 2014, we opened an investigational new drug application and commenced a Phase 2 proof of concept trial to evaluate the efficacy of SMT19969 against the current standard of care, vancomycin. The trial, which is being conducted in the United States and Canada, will enrol up to 100 patients, with half receiving ten days of dosing with SMT19969 and the other half receiving ten days of dosing with vancomycin.

“The primary endpoint of the trial is measuring sustained clinical response. This is defined as clinical cure based on the resolution of diarrhoea at the test of cure visit on day 12 of the trial and no recurrence of CDI within 30 days following the end of treatment. A number of secondary endpoints will also be examined including safety and tolerability of SMT19969, and the impact SMT19969 has on the gut flora of the patients. As we have previously forecasted, we look forward to reporting top-line data from this trial during the second half of 2015. Based on our progress to date, we are now able to estimate more accurately that these data will be available in the fourth quarter.

“We have a clear strategy for our two programmes. Our strategic goal for the DMD programme is to independently develop a utrophin modulator drug through clinical trials and, if successful, commercialise it ourselves in the United States and Europe. We believe that we will have the capability to commercialise this programme ourselves because DMD is an orphan disease with a concentrated network of clinicians and patient advocacy groups.

“With our CDI antibiotic, our objective is to maximise the commercial potential of SMT19969 and we will look to achieve this either independently or through establishing collaborations with third parties. We intend to continue to evaluate the relative merits of these options.

“Operationally, the Company was able to achieve a significant milestone following the completion of our initial public offering, or IPO, of our American depositary shares on the NASDAQ Global Market in the United States. This offering raised total gross proceeds of $39.3 million and increased access to a wider network of specialised healthcare investors. The new funds are helping to advance our lead clinical product candidates SMT C1100 and SMT19969, while also supporting the parallel development of our pipeline of future generation utrophin modulators as we seek to retain our leadership position in the field of utrophin modulation.

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“The good progress made by the Company over the past year means that we are now entering an important period as we look forward to reporting clinical trial results from both the DMD and CDI programmes before the end of 2015. We are excited about the potential of each of these programmes as we look to establish their potential as treatments for life threatening conditions. I would like to take this opportunity to thank all the patients and their families for their involvement in our various trials. Finally, on behalf of the Board, I would like to thank all shareholders for their continuing support. We look forward to reporting on our future progress.”

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About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and commercialization 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 Duchenne muscular dystrophy and the infectious disease C. difficile infection.

For more information, please contact:

 

Summit Therapeutics Glyn Edwards / Richard Pye (UK office) Erik Ostrowski (US office)		Tel: +44 (0)1235 443 951 +1 617 294 6607
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray / Tony Rawlinson		Tel: +44 (0)20 7148 7900
N+1 Singer (Broker) Aubrey Powell / Jen Boorer		Tel: +44 (0)20 7496 3000
MacDougall Biomedical Communications (US media contact) Michelle Avery		Tel: +1 781 235 3060 mavery@macbiocom.com
Peckwater PR (Financial public relations, UK) Tarquin Edwards		Tel: +44 (0)7879 458 364 tarquin.edwards@peckwaterpr.co.uk

Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about the clinical development of our product candidates, the timing of clinical results 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, 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. In addition, any forward-looking statements included in this press release represent our

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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.

Exhibit 99.2

 

Summit Therapeutics plc

(“Summit” or the “Company”)

RESULT OF ANNUAL GENERAL MEETING

Oxford, UK, 14 July 2015 – Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection, announces that Resolutions 1 to 11 proposed to shareholders at the Company’s Annual General Meeting (‘AGM’) held earlier today were duly passed. The results of the proxy votes lodged in advance and at the meeting will be available shortly from the Investors section of Summit’s website, www.summitplc.com.

Resolution 12 (the final resolution): “Disapplication of statutory pre-emption rights”, was not proposed to shareholders. Instead, an ordinary resolution to adjourn the AGM in accordance with the provisions set out in the Company’s Articles of Association was proposed by the Chairman and approved by those shareholders in attendance at the AGM.

As explained at the meeting, the purpose of the adjournment is to allow the receipt of additional proxy forms from certain shareholders, whose proxy votes had not been received ahead of the deadline prior to today’s meeting. The meeting proceeded as the effect of these proxy votes would not have been material to the other resolutions, but the adjournment was proposed to enable the voting intentions of shareholders to be recognised in respect of the final resolution.

The adjourned AGM will be reconvened at 12.00 noon on Wednesday 29 July 2015 at the offices of Fasken Martineau LLP, 17 Hanover Square, London, W1S 1HU. Proxies lodged by shareholders in advance of today’s AGM will remain valid. Any further proxy votes should be returned as soon as possible but, in any event, so as to be received by Capita Asset Services, PXS, 34 Beckenham Road, Kent BR3 4TU by 12.00 noon on Monday 27 July 2015. Any shareholder requiring a further proxy should contact Capita Asset Services on +44 (0)871 664 0300. Calls cost 10p per minute plus network extras. Lines are open 9.00am to 5.30pm (no other method of communication will be accepted).

Shareholders who wish to appoint one or more proxies or to give an instruction to a proxy (whether previously appointed or otherwise) via the CREST system, must ensure that CREST messages are received by the issuer’s agent (ID number RA10) not later than 48 hours before the time appointed for holding the adjourned meeting, that is, by no later than 12.00 noon on Monday 27 July 2015. For this purpose, the time of receipt will be taken to be the time (as determined by the timestamp generated by the CREST system) from which the issuer’s agent is able to retrieve the message. The Company may treat as invalid a proxy appointment sent by CREST in the circumstances set out in regulation 35(5)(a) of the Uncertificated Securities Regulations 2001.

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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 Duchenne muscular dystrophy and the infectious disease C. difficile infection.

For more information, please contact:

 

Summit Therapeutics Glyn Edwards / Richard Pye (UK office) Erik Ostrowski (US office)		Tel: +44 (0)1235 443 951         +1 617 294 6607
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray / Tony Rawlinson		Tel: +44 (0)20 7148 7900

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N+1 Singer (Broker) Aubrey Powell / Jen Boorer		Tel: +44 (0)20 7496 3000
MacDougall Biomedical Communications (US media contact) Michelle Avery		Tel: +1 781 235 3060 mavery@macbiocom.com
Peckwater PR (Financial public relations, UK) Tarquin Edwards		Tel: +44 (0)7879 458 364 tarquin.edwards@peckwaterpr.co.uk