Salarius Pharmaceuticals (SLRX) 7 Mar 182017 Q4 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Q4 2017 Flex Pharma, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions].

conference recorded. this reminder, a is being As I conference, Ms. to introduce for today's your host would like Elizabeth Vice Woo, Corporate and Senior President of Relations Investor Communications. begin. may you Ma’am,

XXXX Thank and outlook. XXXX recent detailing financial joining as you release results. well Pharma’s you, announcing recent and business full we results quarter to our progress issued our and press fourth year discuss and Flex today, fourth Bruce. for full and year as morning Earlier quarter Good highlights us thank a

filings Bill disclaims otherwise. a Chief And including make call overview Tom brief and McVicar. CEO, and these about from or information the provide those find detailed Web circumstances, other regarding I’ll section the to forward-looking materially expectations, at current on Dr. a plans, undue product our can and our it We’ll strategy, our resources. Bill future call You documents factors making our these the with and and contained pass of site filed results any statements, cash on development Q&A. our and Wessel. events and statements. consumer today potential flexpharma.com. up Pharma place plans on our be future differ obligation allocation drug Officer, you uncertainties, statements the will open of future certain for these are new events with the is due to candidates, information, Medical to operations now SEC including time-to-time. on expectations about Today, These in McVicar; future then Actual and we risk Flex XX-K statements reliance forward-looking our should SEC the as and result risks not statements for expectations, and of in we product candidates update based capital and our whether studies may CEO

the I’ll today. for Tom our data joining business all the Elizabeth. Phase state call on remarks month Wessel, about the ALS Medical call brief to Thank readout moved overall forward. patients a upcoming U.S. design well us thank Officer, the the this make brief Chief and XX key ongoing Good then in later as with a clinical with you over of important the that morning of X turn an as for review few programs and accomplishments you, to and Australian MS in recap XXXX trials trial an Dr. about our year CMT was

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by the $X.X quarter design the was shortly. product, of will non-endurance a vast muscle reported consumer company using recorded used business, who unit over the $XXX,XXX two-week approximately volume through and XX%. year ended quarter for athletes you Year-over-year or a revenue for pain and muscle our trial in results to for soreness HOTSHOT, consumer this approximately when study, of before of athletes total regard month. million the and report a growth XXXX. surveyed In-Home to the less after the among of In fourth endurance top XXXX use the study recent majority fourth workout, expect conducted XXX HOTSHOT Tom product. of With approximately We December XXXX, from the its take XX, this this for line end period

the result, beyond claimed muscle a soreness has to its potential lessening to now As include expand pain. benefits HOTSHOT just cramping and

our in Tom with the will weeks X Charcot-Marie-Tooth call progress. patients, time, assist with just results we consideration for we you an two to number CMO, robust expect studies study consumer alternatives plans In As Phase Dr. position of Wessel, report mid-XXXX. the strategic transformational few months, now of bank spasticity current investment for engaged know, to X our business. to Flex the be the a in followed and operating on turn will I clinical in exploratory to supports next cash the funding over from by update MS as first HOTSHOT an you our there our Phase to XX trials, ALS and a clinical

you, Bill. Thank

to several data we X blinded, Let the do endpoints spasticity. MS exploratory did and XX reporting Phase will study we understanding a months regarding spasticity the we exploratory relieved out not in enrolled by no of at was When me of not Phase this with included trial for now trial daily. conceived, XX-day effect few with least of any to this month. cramps end we then we of to during milligrams intent over Hence, randomized, This study, ODT period. spasms. patients on started nor on XX-day treatment to review approximately formulation. with characteristics that not trial FLX-XXX current additional first an and establish moments design treatment treatment take other baseline be the When period by FLX-XXX received our XX followed three patients current an gain the effect and designed this a therapy. in and the treatment by given formulations the trial XX-day were or The placebo-control crossing have treatment on of of washing potential X run-in this Patients before placebo-controlled Xx or of MS placebo spasticity, which FLX-XXX FLX-XXX did periods liquid we our have period duration

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with Both are evaluated run-in, a with Phase for primarily double-blinded, are the of review baseline control with Charcot-Marie-Tooth of treatment. cramp United designed and Now evaluate design. evaluate COMMEND disease, trial milligrams ALS let Xb and COMMEND administered solely is motor to an as The trial will the group days ongoing States muscle endpoints, States. two who clinical quick of secondary in are COMMIT XX cramping. Xx the be our in ongoing including daily randomized, a is to identical to number patients establish me designed randomized patients studies which the for under parallel of study PGIC, in trial suffer for Phase provide to patients neuron FLX-XXX of endpoint neuropathy. The studies in and the run-in our After controlled, FLX-XXX ongoing These in cramps. muscle or Xb CGIC, the severe in an have changes update a studies these United XX a X from primary and period FLX-XXX cramp frequency. conducted COMMIT are clinical frequency being They FLX-XXX XX-day studies spasticity. pain a Phase cramp-related clinical an with Patients is IND

by enroll early have the end of Our about the in study. to study data XXXX. to the completers at study target ALS CMT XXXX anticipate about from patients in quarter We this from XX XXX XX to is first the and the of study

Now, the call turn I’ll to back Elizabeth.

Bruce? Operator, for us our the directions. joining the to Q&A you like would Financial the And of Officer, John we Chief Tom. up McCabe. call give you, if open are portion call is Q&A for ready Thank the to

Instructions]. [Operator

the ROTH from comes question of line first from Jotin Our Marango Capital.

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you. morning and the Good on team progress. congrats Thank

first like The I Tom. a neurons, get so directly question, just to nerdy I’ll go to about little

Australian last pointed ALS in study the recall improvement reported see So study did cramping. trend in you year, a even you the was spasticity though that I at

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then Okay, development Bill. in question year two With then should interactions out What last you. is other MS looks the programs understood. and expectation And regulatory CMT, your ongoing in a plan to have step, regulatory reasonable and a laid me Thank your for ALS timetable nice what of there? path. plan, to of course, I’m and what signal the would there? about asking just next be you. development So a that sequence Thank assume the or would for see a but clinical the them not be you fair of

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we As to priority those clinical highest complete is a effort it problems our confidence know, in of absolute of are these studies organization great have and you complex our multi-factorial team. recruit putting as are every the I planned. level those and and

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morning, guys. operator. Thanks, Good

Michael. Hi,

A there. you. questions couple for of Hi,

data Maybe some seeing delay if us top can in causing you early screening. give the that’s identification off, feedback First line if it’s of on COMMEND, patients a 'XX in the from results?

to the get the mentioned way You more these into you’ve us take collectively may close XX sites. along a Give patients bit XXX taken other if detail what recently you steps and to any two steps trials? Thanks. to there’s

Thanks for that question, Michael.

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relatively can are year. recruiting typically are of of these are the we their with for relatively physicians getting these issues know up the a to sort of when their is so be are regard visits the infrequent investigators trade one that and than stable, less patients patients the learning And curve tricks once – And really patients. and to

little use there outreach those to sites and patient-centric is clinical then study. a more for patients to of the strategy present themselves in to sort participation then the encourage the So

feedback of helpful. for planning QX, couple dysphagia still let one and dialysis good any questions asked, I think those me renal on in ask two? on been A very That’s on start so there. timing the the Thanks. to appreciate Okay. I that – have updates

comment you dysphagia. Yes. would like Tom, to on

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in us. increased medical that lead drug an this dysphagia. is there this know, where an are approved no you a and program populations, of especially We therapies of and for as number for then But this patients well. post-stroke course, is interest of the motor disease. other Parkinson's enormous is And complications area So pneumonia can know aspiration one patients to in of neuron largest with disease as

So also we’re and swallowing out functions. investigators to of in in various have of globally the assessment function reaching that expertise the in patients these assessment bulbar

FLX-XXX. will cycle thoroughly. this we’re we see be investigate our are occur the very and to also this starting a patients behavior Similarly, in I next during to a observational So of dialysis but in area renal data development now between important patients understand be in the dialysis some these detailed for on we going reporting setting they for more sessions the to in the dialysis, understand stage dialysis that as of cramping of midst patterns the up more as to potentially collecting study visits.

these cramping best patients. important natural that is our to bit the to it identify of suspicion how more that subset learn pattern and will cramping patients So a little an it’s just patterns be of and these a patients increased this have about

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Michael. you, Thank

of Andrews Our the from next question line comes from Jefferies. Matthew

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Thank you. the you for Thank is Roger taking for question. This Matt.

first question relates and my to COMMEND So COMMIT.

on So on thank the additional timeline. the you color delay providing for slight

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Roger. welcome, You’re

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categorize ALS strategic the any? So after your this partner’s change if in Thank interest data Australia in you. can you of XXX, licensing November,

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to on milestone be it’s for a course comment of strategy beyond big But a wouldn’t So the that. company. any we in position

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Hi.

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the we molecules strategy an typically assets. of and Book IP to into anticipate based of go years we data The the protecting patents typical approval, of can you strategy I detail pursuing. Orange patents to that of data aggressive listed. discussions, cramping protect method upon like continuing spasticity use that five is on symptoms those our level the these and treat these to have but neurodegenerative protection and benefits tell Obviously, we’re that use in from disease were will in exclusivity we addition don’t the exclusivity Well,

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you your conclude participation thank gentlemen, the This does and in Ladies for program. today’s conference.

may disconnect. have day. great a all You Everyone,