Good day, ladies and gentleman. And welcome to the Summit Therapeutics Plc Financial Results for Fourth Quarter and Fiscal Year Ended January 31, 2017 Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Mr. Richard Pye. Please go ahead, sir.

Thank you. And welcome to everyone, joining us on our call to discuss our financial results for the fourth quarter and fiscal year ended January 31, 2017, and our operational progress. Earlier today, we issued a press release summarizing this information. If you had not had a chance to review, it is available on our Web site at www.summitplc.com. Joining me on the call today are our Chief Executive Officer, Glyn Edwards; our Chief Financial Officer, Erik Ostrowski, and our Chief Medical Officer, Dr. Ralf Rosskamp. Before we begin our discussion, I would like to remind listeners that we will be making forward-looking statements during this call. I therefore refer you to our filings with the Securities and Exchange Commission for description of the risks and uncertainties associated with an investment in Summit Therapeutics. While we may elect to update these forward looking statements at some points in the future, we specifically disclaim any obligations to do so, even if our views change. These forward looking statements should not be relied upon in representing our views as of any date subsequent to today. I would now like to turn the call over to Glyn for an overview of our year and more recent corporate activities.

Thanks, Richard. And thank you all for joining us as we discuss a productive year in our C. difficile infection, or CDI, and Duchenne muscular dystrophy, or DMD, program and we’ll set the stage for the year to come. The excitement in the DMD and investment community surrounding our utrophin modulation program and DMD has gained momentum over the past year for a good reason. We’re now in a Phase 2 trial, called the PhaseOut DMD, where we have the opportunity, for the first time, to see if utrophin modulation can demonstrate the disease modifying results in patients that we have already seen in animal models of DMD. If utrophin modulation provides clinical benefits in this Phase 2 trial, it has the potential to do so for the entire DMD population regardless of their genetic fault that causes the disease. Utrophin is the protein that acts as a molecular shock absorber in muscles similar to dystrophin, but these two proteins acted different time points in muscle developments. Utrophin is present when a muscle is first laid down or when it's repairing after damage. As the muscle matures, utrophin is down regulated and dystrophin takes its place in the mature muscle. In DMD affected muscles, utrophin is present at the quite high levels because there’s a loss of muscle related repair taking place. But utrophin is naturally down regulated as the fiber matures, and with no dystrophin to take its place the muscle degenerates. Our goal is to modulate or change the production of utrophin so that it's continuously produce and can substitute the dystrophin in the more mature muscle fibers. In animal models, we're able to protect against the loss of muscle function expected in DMD with the administration of our lead utrophin modulator ezutromid. This past year, we initiated…

Thank you, Glyn. I’ll now provide an overview of key components of our financial results for the fiscal year ended January 31, 2017. We will of course provide detailed results in our regulatory filings and I encourage all to you to review those accordingly. We present Summit’s results in accordance with International Financial Reporting Standards and pound sterling, but for convenience purposes, I’ll give U.S. dollar equivalents for certain key numbers. As we described in our earnings release today, we completed our financial year on January 31, 2017 with cash and cash equivalents of £28.1 million or $35.3 million compared £16.3 million at January 31, 2016. Turning to the income statement, revenues were £2.3 million or $2.9 million during year ended January 31, 2017 following our entry into an exclusive collaboration and license agreement with Sarepta Therapeutics. Under the terms of the agreement, we received an upfront payment of $40 million, which we have recognized invariably over time. Research and development expenses increased to £19 million or $23.9 million for the year ended January 31, 2017 from £16.9 million for the previous year. This was primarily due to increased spending related to our DMD program and an increase in R&D related staffing costs offset by a decrease in spending related to our CDI program, which was due to the completion of our Phase 2 clinical trial of ridinilazole versus vancomycin. General and administration expenses increased to £8.3 million or $10.4 million for the year-ended January 31, 2017 from £4.8 million for the previous year. This increase was driven by increased legal and professional expenses, and negative movement in exchange rate variance, as well as staff related costs. Our income tax credit for the year increased to £4.3 million or $5.5 million for the year-ended January 31, 2017 from £3 million for the previous year. This was driven by our overall increased R&D expenditure, which resulted in a related increase in our R&D tax credit. And finally, net loss for the year increased to £21.4 million or $26.9 million compared to £20.1 million for the previous year. Turning to the cash flow statement, the Group had a net cash inflow of £12.5 million or $15.7 million for the year-ended January 31, 2017 as compared to a net cash inflow of £4.9 million for the previous year. This year's net cash inflow was primarily the result of the receipts of $40 million or £32.8 million upfront payment from our agreement with Sarepta, as well as the receipt of £3 million research and development tax credit offset by our R&D and G&A related expenses. I'd now like to provide our cash guidance. We expect that our current cash resources plus the anticipated $22 million milestone payment under our agreement with Sarepta related to the first dosing of the last patient in our PhaseOut DMD study, will fund the Company through December 31, 2018. I’ll now turn the call back over to Glyn for closing remarks. Glyn.

Thanks, Erik. In summary, it's been a year of great progress across all areas of the business and way for the exciting time ahead. I'd like to close by thanking the shareholders for their support and our employees for their hard work and dedication to help progress on the two programs that have the potential to significantly advance the current standard of care in their respective disease areas. Our patients and their families are counting on us, and we’re committed to ensuring the best chance of success in DMD and C. diff. And with that, I'll take any questions.

Thank you [Operator Instructions]. We’ll now proceed and take our first question from Hartaj Singh from Oppenheimer. Please go ahead.

This is Emma on for Hartaj. Thanks for taking the question. Could you talk in a bit more detail just about the specific assays you've developed to analyze these biopsies. And kind of how you’ve been able to overcome the challenges specific to measuring dystrophin or utrophin in these patients versus dystrophin?

Yes, as you know and we’ve had detailed discussions with several of herewith, we spend a lot of time and efforts on a number of these assays. Just in order to keep this fairly brief, our focus on the utrophin assays and on the developmental vancomycin assays, which looks at muscle fiber maturity. And both of these assays are measured from the histopathology and the biopsy sample. And so things have come a long way in this field generally in measuring these muscle proteins. And in particular, we've been able to bring in expertise from other therapeutic areas and from companies that have been developing other assays, which have been in use of endpoints in clinical trials in both Europe and the U.S. So we've moved away from the fluorescence type assays, if that you remember from the Prosensor and Sarepta advisory panels with their technical shortcomings to a more convention and histochemistry point of view. And that gives you much more reliability, bigger dynamic range and much tighter distributions of an intra assay variability. So we've been able to actually get the quantification of these assays into a much more reliable position. Then specifically looking at utrophin, as you know one of the big challenges for us compared with the technologies that are developing products that simulate the production of dystrophin is that in the DMD patient there's no dystrophin. If you see some dystrophin, then you can count that as a win although you then get into obviously how much dystrophin is needed. In the case of utrophin, as I said in my preamble, the patients are producing a lot more utrophin than a healthy individual would be because there's a great deal of regeneration going on in their muscles because of the damage that's done, caused by…

Just a quick follow up so with the full 24-week analysis now, especially in the first quarter of 2018. Is it possible that we might see an improvement in the functional message of that plan, particularly in F6 cohort? Or is it focused really on that uniformity of utrophin distribution and improvement in the muscle fiber maturity?

So, it's important to measure these functions, just to take these functional measurements. We're looking at a variety of them. But as we’ve guided people, this particular trial design is not optimized to give us a clear result from the functional measures. For two reasons, one is, there is no control arm. And so to look at these things, we have to look at historical controls. And secondly, this is a pretty wide age range to be -- for a trail where functional endpoints are of significant importance. So if you look at the PTC trials or Sarepta's current trails, if you're looking at, for instance six minute walk test, you would actually recruit patients in a much tight range; so to reduce the heterogeneity to stand any chance of seeing it. We will see what we’ll see and we’ll share that information with you. But our focus is really on data that comes out from these biopsy samples and from the MRI where each person's control is at pre-treatment stage compared with their post treatment state. Ralf do you agree with that, would you like to add anything to that.

No thank you, you captured it well. We know that as we said we will report the six months functional data, and as you know, in those other studies. You start observing changes after one year, but we’ll also on the MRI data. And that’s our primary endpoint, and it's potentially foreseeable that the six months time frame, you would be able to observe some changes over this short period of time.

The next question comes from Chad Messer of Needham & Company. Please go ahead.

I was just wondering if cancelling the earlier interim in PhaseOut has any power calculation impact?

That’s a good question, and it does help. So what's rather than a pure statistical level, just more qualitatively, doing all the biopsy samples at one times makes the result more reliable; you’ve got bigger number and you’ve got better reproducibility if you're doing these assays much closer together. So, we just feel that having the complete data set and doing just one analysis on it give you a personal and more robust answer and a clear answer is the answer. Whereas if we did sort of six or eight patients first and then another 14 or 12 later on, you kind of got two looks of incomplete data and then you have to pull -- better to do it all at once, get a least very clear unequivocal answer. And if we’re thinking about what happens next, we need the data from both the F3 and the F6 in order to select the dose of the registration study. So actually, we can't really make any final decisions on the registration study design, so we've got that F6 data as well, which we will have all at the same time. So it seem to us the more robust scientifically and not an overall delay in progress of the trial if we looked at all this data all at once and gave a single clear answer to that before we test that.

Just so I am clear, you would not have had F6 in the earlier interim or would have been all F3?

It would have been six or eight F3 patients, if we done that analysis. And we’re on track -- we’ve had those numbers, but we've chosen not to do the biopsies not to look at that data but to rather wait till we've got the complete sets of 24-week biopsies from both F3 and F6 and do the analysis altogether and announce the results altogether.

Then just on your cash guidance, I wanted to double check if that wouldn’t include anything for the C. diff Phase 3. And then since you’re in the planning stages for that now, is it possible to show what that sort of a rough idea of what that program might cost?

In terms of the current cash guidance, that really just includes Phase 3 preparation related activities. So we’ll clearly need to raise some capital to fund the Phase 3s. As you know, those are rather large trials to 700 patient trials included there. So, just based on initial estimates to give you a directional view on what those might look like, we're estimating roughly about $100 million to conduct those Phase 3s and C. diff program.

Thanks, that's very helpful.

And just with regard to that when Erik says raise, he doesn’t mean that he’s going to do equity raise to raise $100 million. We've been looking at a lot non-dilutive sources of funding. And as you know, we've been in partnership negotiations for quite some significant period of time. So, we need to bring that amount of money into the program. But we expect to see -- that will largely, if not entirely, come from these sources of partnership and/or government and non-government sources of money.

Thanks, you've been pretty consistent in saying that. Thank you.

The next question comes from Joseph Hedden of Rx Securities. Please go ahead.

Just a couple on ezutromid, I was wondering if you could provide us with an update about when you think a registrational study might now stop, and then just on PhaseOut DMD. Looking at the picture of dosing across the trial now, can you just remind us actually what that looks like? So, you've got 30 patients on the old formulation is at 2.5 grams twice daily. But then what dose level to the F6 got carried into the trial? Thanks.

Ralf, could you answer the F6 dosing question.

Yes. As you said, correctly, the F3 is dosed at 2.5 grams twice daily and the F6 is dosed at 1 gram PID.

So, is that just one level that got carried through?

Yes, it’s a fixed dose in for both the F3 and the F6 formulation. And we are measuring the plasma concentrations frequently throughout the study, which will then allow us to look at the actual plasma concentration and its relationships to any outcomes to define our concentration response range.

Okay, thank you.

And the first part of your question, Joseph, was about the registration study, when's it going to start. We're not, in this call, providing any new guidance on that. And we're just advising that we should get the data on which we'll be able to make all these decisions in quarter one of next year.

[Operator Instructions] The next question comes from Carol Werther of H.C. Wainwright. Please go ahead.

I was just wondering, do you have any idea, at this point, what the combination trial will look like with Sarepta's drug, and how much that might cost next year? Thanks.

Thanks Carol. That's another good question, because obviously, one of the -- two exciting opportunities for us in the Sarepta collaboration, the first is that we got access to the expertise. And obviously they, whatever marketing infrastructure they put into Europe, we can leverage that. But the second is that one of the hugely exciting things about utrophin modulation is because it’s orthogonal to what the other guys are doing in trying to modify dystrophin that you have the potential to see certainly additive and potentially synergistic effects of the drugs in use. But our primary driver and our critical path is to show single agent activity, and to get single agent approval. So the work that's going on at the moment in terms of combinations is all non-clinical work look at animal experiments. And as yet, we have not announced what the combined clinical program will look like nor when it’s going to start. And as I say, our prime driver is to make sure we get the optimal design for study to get approval for single agent activity. And Sarepta are right behind us on this approach. They think it's exactly the right thing to do as well.

Will we see any of the non-clinical data?

Yes, there'll be published in the usual places and conferences, and so on.

The next question comes from Arlinda Lee of Canaccord. Please go ahead.

I had a question on the timing of the discussions with FDA and EMA. And so I guess originally, we thought you were going to start Phase 2 registrational trial this year, but if your data is not coming. Until next year, is there any information that you can glean from any incremental looks to kind of keep the discussions going forward? Or are you going to just wait until 1Q and then take couple of packages and look for more…

That’s a very pressing question, actually, Arlinda, to note. So we're ramping up our regulatory interactions, both through the EMA and the FDA. And we’ll be having meetings with them before we get the data. We're having meetings within at least once and possibly twice during this calendar year; so that we're all geared up with -- to have the most rapid start with the most confidence that we're doing the measurements and have the endpoints that those authorities would accept.

Okay great…

There’s a whole lot of other things, and not related to that like manufacturing and all these going things. And you need to do those as well that are significant part of the program. And obviously, you need regulatory interaction with those to talk package and so on. But even on the endpoints and the trial design and all those aspects, we can learn a lot before we’ve got this data to make sure that we have the most rapid rollover into a registration study.

Ladies and gentleman, there are no further questions over the telephone. So that will conclude today’s conference call. Thank you for your participation. And you may now disconnect.