Elizabeth Woo - Senior Vice President, Investor Relations and Corporate Communications Bill McVicar - Chief Executive Officer Tom Wessel - Chief Medical Officer.

Alina Levchuk - Cantor Fitzgerald.

Good day, ladies and gentlemen, and welcome to the Q2 2017 Flex Pharma Incorporated Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Elizabeth Woo, SVP, Investor Relations and Corporate Communications. Ma'am, you may begin..

Thank you, Heather. Good morning. Thank you for joining us to discuss Flex Pharma's second quarter 2017 financial results as well as our recent progress and outlook. Earlier today, we issued a press release announcing recent business highlights and detailing our second quarter 2017 results. You can find these documents on our website at flexpharma.com.

Today, we will be making certain forward-looking statements about future expectations, plans, events and circumstances, including statements about our strategy, future operations and the development of our consumer and drug product candidates, plans for future potential product candidates and studies and our expectations regarding our capital allocation and cash resources.

These statements are based on our current expectations, and you should not place undue reliance on these statements. Actual results may differ materially due to our risks and uncertainties, including those detailed in the risk factors section of our 10-K filed with the SEC and other filings we make with the SEC from time to time.

Flex Pharma disclaims any obligation to update information contained in these forward-looking statements, whether as a result of new information, future events or otherwise. We'll provide a brief inner view and then open it up for Q&A. I now pass the call to our CEO, Bill McVicar..

Thank you, Elizabeth, and good morning, everyone. At Flex Pharma, we are dedicated to delivering novel treatments for neuromuscular disorders to patients in need.

It is my honor to lead the company based on foundational science of Nobelist Rod MacKinnon that is focused on alleviating severe, painful and debilitating cramping and spasticity prevalent among severe neurological diseases such as ALS, Charcot-Marie-Tooth and MS.

When I joined Flex this past spring as the Head of R&D, I focused our talented team of scientists on operational execution and excellence. Now, as CEO, I'm dedicated to driving our strategy to focus on well-defined orphan patient populations. We have accomplished a number of important development objectives over these past few months.

First and foremost, the recent Fast Track designation represents a validation by FDA that cramps are a severe, unmet medical need in ALS.

We see greater collaboration with the FDA under Fast Track as an important catalyst in our efforts to accelerate the development of FLX-787 to address the suffering of patients with painful, debilitating cramps as a consequence of their severe neurological disease.

We look forward to continuing our collaboration with the FDA to precisely define and accelerate the clinical development of FLX-787. In addition, our IND is now effective, which enables us to expand our clinical program in the US, where we now have initiated our Phase 2 COMMEND trial in ALS.

We expect our Phase 2 COMMIT trial in CMT to follow soon with enrollment beginning this quarter. Our COMMEND trial is a Phase 2 study designed to evaluate FLX-787 in patients with motor neuron disease, the M, N and D in COMMEND, and it will primarily enroll ALS who suffer from cramps.

The randomized, controlled, double-blind, parallel design trail includes a four-week running period to establish a solid baseline cramp frequency. Patients are then randomized to either 30 milligrams of FLX-787 administered a day, or control, for 28 days of treatment.

Patients will be evaluated for changes in cramp frequency from their individual baselines as the primary endpoint with a number of secondary endpoints.

The COMMEND trial has many advantages over our smaller, exploratory Australian ALS study, including longer run-in and treatment periods, a higher dose of parallel design and, of course, a much larger population from which patients can be recruited.

As a result, we've elected to prioritize and focus our efforts on the US COMMEND study and end the exploratory Australian ALS study early with roughly a dozen patients.

The data from the Australian study will inform our larger COMMEND clinical trial particularly regarding baseline cramp frequency and intra-subject variability which could influence sample size calculation and other aspects of trial conduct for this more robust US study.

The COMMIT trial is a Phase 2 trial in Charcot-Marie-Tooth patients that is essentially identical in design to the ALS trial. In June, the Inherited Neuropathies Consortium endorsed the protocol for this US Phase 2 trial of FLX-787 in CMT patients who suffer from cramps.

This is an important endorsement because the INC, as an integrated group of academic medical centers, patient support organizations, and clinical research resources is dedicated to supporting clinical research in CMT with the potential to improve the care of patients. Surprisingly, there are currently no drugs approved in the US for this condition.

Consistent with our goal to deliver high quality data from well-designed trials in a timely manner, these two robust Phase 2 trials will provide important data readouts in the middle of 2018. I am also excited about testing the potential of FLX-787 in our exploratory MS spasticity study in Australia.

The literature reports that roughly 85% of MS patients experience spasticity with about 40% experiencing moderate or severe spasticity which progresses with the disease and has a greater impact on quality of life than they are cramping which is much less prevalent.

Compared to ALS, there are more than 10 times more patients that suffer with MS and the associated spasticity, making MS a high value indication for any effective treatment.

However, in contrast to cramping where we have supportive activity data in humans from both electrically induced and spontaneous cramping models, we have no such prior human data that would predict anti-spasticity activity with FLX-787.

As a result, the small exploratory crossover study design with a liquid formulation was designed to look for evidence of activity in spasticity rather than definitely proving efficacy.

While we would not design the study this way today, there may be very valuable information to the GAIN study in the estimates of effect size and intra-subject variability that could shape the design and power of a definitive Phase 2 trial in multiple sclerosis.

Our plan is to complete approximately 45 subjects in this Exploratory study in Australia this year and report what we find in the first quarter. If these data are supportive, we would then file a separate IND for spasticity and initiate a larger definitive Phase 2 MS trial.

Thus, in early 2018, we'll have learned a bit about the potential of FLX-787 for the treatment of spasticity and then in mid-2018, we will know the anti-cramp potential of the drug from large, well designed Phase 2 trials in ALS and CMT.

Moving on to the consumer business, second quarter revenues from HOTSHOT were $336,000 and we expect full year 2017 revenues to exceed those from 2016. Having just finished the first full year on the market, we've learned a great deal. First, we know we have a product that works.

Those that attended Flex Hour last week heard testimonials from three endurance athletes about how HOTSHOT has helped them each in their own way. Thousands of endurance athletes in over 400 professional and collegiate teams are HOTSHOT customers.

And they report using the product to treat and prevent exercise-associated muscle cramps as well as for other neuromuscular performance benefits such as the speed recovery and reduced muscle soreness. Number two, our customers are passionate about the product.

Our repeat buyers use HOTSHOT regularly to prevent cramping and have made HOTSHOT a part of their training and racing regimens. HOTSHOT has developed a base of passionate, loyal, satisfied repeat customers amongst endurance athletes.

As an example, the first woman to complete seven marathons on seven continents in seven consecutive days told us that she insisted that she have HOTSHOT waiting for her at the end of every race to help her recover for the next one.

Number three, for new product with just a year on the market, we have learned a lot about the key business drivers, awareness, trial and repeat, and we are working to optimize these. But it takes time to build a new business.

In order to expand our customer base and add new customers, we're concentrating on increasing awareness and trial through, for example, you know, our partnership with IRONMAN which allows us to sample on the course at all IRONMAN and 70.3 races for the remainder of the season.

As we drive the clinical development of FLX-787 and work to grow the HOTSHOT consumer business, we are moderating investments to appropriately recognize HOTSHOT's medium and long-term value.

As the CEO of Flex, I am thrilled to be taking the helm at this key moment for the company and to drive the important value creating initiatives that will benefit patients, athletes and our shareholders in the months and years to come. I'll now turn the call back to Elizabeth..

Thanks, Bill.

Heather, our operator, would you now open the Q&A and give instructions for participants to ask questions?.

Thank you. [Operator Instructions] Your first question comes from the line of Alina Levchuk with Cantor Fitzgerald. Your line is open..

This is Alina Levchuk in for Mara Goldstein with Cantor. So, we just have a quick question about the timelines for the project and the..

Hello?.

Yes, can you hear me?.

Yes..

Great, okay..

You just dropped out for a second there, Alina, but keep going. And I think we'll get it..

All right. So, we're looking for the timelines around the trial. So, the readout in Australia you said is going to be sometime around mid-2018 for spasticity.

Does that overlap with CMT Phase 2 that is planned in the US?.

Actually, the readout for MS, we expect in the first quarter..

Okay..

So, we're going to finish enrolling subjects thus year and then we'll read out the data early in 2018. And then the more robust US CMT trial will read out in summer of 2018..

As well as the ALS..

Yes, ALS as well..

Yes, well designed Phase 2 under IND..

Okay, got it. Thank you that's helpful..

Thank you. [Operator Instructions] Your next question comes from the line of Michael Higgins with ROTH Capital Partners. Your line is open. Michael, please check your mute button..

Thanks for taking my questions. This is actually Rohit [ph] [indiscernible] in for Michael. I have a couple of quick questions. One about the ALS COMMEND trial, I was wondering if you could tell us how many patients you plan to enroll. I've seen different numbers in different places..

Yes, sure, thank you, Michael - sorry, not Michael. Rohit [ph] Yes. We expect to enroll about 100 patients in that trial. And there's actually a bit more detail on it if you're interested in our clinicaltrials.gov page or information page..

Right, right. So, that's where I saw 120 whereas in other places I saw something closer to 100, so that's helpful if anything..

Yes, I think the larger number may have referred to the number of subjects we expect to screen, which sort of officially are in the trial, once they're consented and screened, but the ones that is for completing from which we will gather our dataset is around 100..

Okay, okay, thank you.

And then another question about the MS program, so you mentioned in your call that you're going to analyze the data from the current Australian trial, and then I am presuming you would initiate a larger trial with this IND [ph] in the US, and would it be with a similar design to what you're doing with the US, the ALS and the CMT trial as well?.

That would be my expectation, yes. It's much more likely that we'll do that trial in the US under the US IND. And I mentioned earlier that we would open a separate IND in order to study spasticity in the US So, yes, I think that those are both the case..

Okay, okay, thank you. And then a final question about the ALS trial in Australia, the crossover design, so you stopped that trial early at 12 patients.

And I'm wondering if data will still be released, and if so, when do you expect that to be available?.

We actually don't expect to release data from that study and the reason being, of course, that with the 12 subjects, we can't make any meaningful conclusions.

We do hope to learn in particular about the consistency of cramping frequency within an individual patient and then the variability between patients because that helps us sort of double check our power assumptions for the well-designed robust US trials. But we don't have an expectation to report data from that trial specifically..

Okay, all right. Thank you very much..

Thank you. Great question..

Thank you..

Thank you. [Operator Instructions] Your next question comes from the line of Roger [indiscernible] with Jefferies. Your line is open..

I'm calling for Matthew Andrews from Jefferies. So, I have two questions about the Australia ALS study. So, I think you have reviewed the data for the 12 ALS patients.

And how would you plan to incorporate into your kind of ALS in US trial, the larger well designed trial? The second question is, so considering your focus on the ALS and the CMT for now and how important the MS spasticity data from the Australian data are and bear in mind the study used the liquid formulation and if [ph] not parallel design?.

Yes, good question. So, on the ALS data from Australia, one of the things that's very helpful is to understand what the consistency is in the cramping behavior of individual patients because in the studies in the US, we're using a good, robust four weeks to gather baseline cramping frequencies.

And then each subject will be compared back to their four week baseline after they've been treated with the drug for four weeks. So, naturally, there are some assumptions about the consistency particularly within a certain patient that allows us to estimate or confirm our power calculations.

So, those data really it's almost the run-in data, Roger, that are more important to us from that ALS trial to kind of validate our power calculations for the US COMMEND trial. And your second question is a good one on MS. I actually think that it could be really important to be able to see a trend of activity in that study.

You're exactly right in that, that is one of the studies with, let's say, the older designs, the crossover design, the liquid formulation. But you might recall that we did have some very encouraging results from some liquid formulations including in the FLX-100 study early in our history.

So, we believe you can still get activity that way, we just believe that it's more optimized with an orally dissolving tablet.

And then, of course, spasticity is a huge and extraordinarily interesting and valuable indication for us, so any hint that this mechanism can impact that, I think we'd be really encouraged by - and I'd ask Tom to just comment briefly on how we think about the mechanism of our drug and sort of its potential for impacting MS spasticity.

Tom?.

Yes. So, we certainly see both spasticity and the cramping as flipside of the same coin that is an expression of the underlying hyperexcitability of alpha-motor neurons in the spinal cord.

So, as Bill mentioned, in the MS study, we had a number of very important exploratory endpoints that will give us some insight into how patients with different clinical presentations, and that's in terms of their underlying spasticity and their underlying cramp frequency, how they respond to this intervention.

This will allow us to sort of gauge for the future whether there is much there and obviously, the treatment of spasticity is a particularly vexing problem.

So, if we were lucky enough to see something that is promising in terms of an effect size on the Modified Ashworth Scale or on the Tardieu Scale, the two spasticity scales that are used in the study, or on the numerical rating scale which the patient actually reports, if we were to see any indications of effect there, we would definitely want to pursue that because this is an area of enormous unmet need in the clinic..

And if I understand correctly, we do think of spasticity as being in the same family of problems where we have a breakdown in the inhibitory signal from the central nervous system that affects this imbalance in tone, in adductor and abductor tone in patients with spasticity..

Got it, very helpful, thank you. I have one last question if I may. So, any change in the level of interest from the strategy since AAN where you, guys, have the opportunity to speak to them on 787..

I'm sorry, you faded out a little bit there at the end, Roger.

What was the question about the?.

Something about AAN, we heard..

Right, yes, so any change in the level of interest from the strategic partner since AAN, you have an opportunity to speak with them on the 787?.

Well, we don't normally comment on that but so..

But suffice it to say that we are in regular conversations with potential partners, and I think in fact, you may have spoken to one when you were here..

Yes, got it, thank you..

You may know more than I do, Roger..

Thank you, that's it..

Thank you. And I'm showing no further questions at this time. I'd like to turn the call back over to CEO, Bill McVicar, for closing remarks..

Well, thank you very much. Thank you, all, for your attention this morning and your interest in Flex Pharma during this very busy time of the season.

We look forward to continuing to touch base with you and the rest of our investors over the next few days and we welcome any questions on the information that we've released over the last few days and including our quarterly results. So, with that, thank you, all, for your time and attention..

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you, all, may disconnect. Everyone, have a wonderful day..