SLRX - Earnings call transcript Q3 2017 | Salarius Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Flex Pharma Call to discuss ALS Data and Q3 Business Update. 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].

As a reminder, this conference is being recorded. to Investor host Relations like Elizabeth today's now SVP, Woo, and would introduce for your conference, I Corporate Communications.

begin. may You

Elizabeth Woo

Thank Gigi. you,

other to filings new in thank including and study or website information we’ll expectations, be we joining exploratory So, open After with two Q&A. we on forward-looking for press Earlier consumer for our our time-to-time. morning result risks current and and resources. these statements and due our these making allocation plans cash these capital circumstances, Actual update issued slides forward-looking product a events on filed results expectations, may reliance SEC everyone discuss certain press and the and will can whether of our and and with regarding we statements, detailed as potential candidates to our found contained candidates, through about future releases today, future information, us we disclaims factors you any of plans, and XX-K about future Today, product Phase SEC operations accompanying the for the strategy, future at slides, and Flex this of our section from should ALS our Pharma flexpharma.com. uncertainties, releases expectations studies These and make QX the statements results. based materially on events statements development place X undue walk in the you be statements. and the drug are differ obligation risk including those our otherwise. not the it to up

Q&A. Officer McCabe, call this Chief I’m part Flex now Bill pass Wessel. call Bill to the will to of Pharma’s Chief John Joining Tom CEO the McVicar. join and is for CEO Officer us going for this McVicar Financial Medical

Bill McVicar

in Flex and activator time is XXX, Pharma, neurological variability. be sharing to today. inter subject signs ongoing the the patients for unexpected of you, our To this us Thank of with and we’re the call although exciting learn clear it very our channel Elizabeth. small on to joining first an activity represents the encouraging we assumptions for to learn confirm the more. anti-cramping we’d This Thank you trip that trial pleased study, dual data From intra much about expect U.S. pleasantly were for for disease. time but surprised severe power Flex

cross-over a Australia had are you, double-blind number placebo remind design neuron inclusion study controlled evaluate This three. to study patients efficacy on shown and of with in tolerability randomized we ALS study Just disease. study motor criteria in patients patient This in in to was started slide XXXX. Flex-XXX

enrollment small However, XXX terminated diagnosed ALS study because large a the we announced in spread July this ALS early over Australian slow year Australia, to patients was per million geographic XX population due this in that range. of was with only year

global in number of focus impression and eight trial X.XX. associated than values baseline, X.XX we endpoints less reduction both including patients trial X.XX% the in enrolling placebo assessments treatment stiffness number by the with numerical reduction US of study early. of statistically the results baseline who larger, percent now end our resources increase the the cramp robust and both a equals slide in X.XX baseline, In change improvements the resulted patients significant both intensity patients in on on protocol, on and multiple X. were consistent cramp based using a clinician's PE NRS. scale cramps per free or of PE relative and from points daily PE were in Flex-XXX completed from summary Australian the trends demonstrated the from These the to on to shown decided which ALS PE control. A more So, are of trial terminate ALS is days the rating Strong and pain

We symptoms. completing who neurological across severe the small endpoints study. larger to more and cramping efficacy alleviate FLX-XXX well robust potential in consistent with debilitating the are data data, particularly benefit population. to our number the potential demonstrate Xb for study. cramping pain, cramps given indicates tolerated and patients in encouraged the generally impact FLX-XXX with related positive multiple chemical of associated first patients the commend related These suffer cramp from very Flex patient this of by to Flex-XXX ongoing the Phase in trial the was the ALS patients These neuro-stimulation disease serious of

related We with in data excited ALS to under efficacy fast-track these In MS, or readouts completing XXXX and results payments ALS from forward CMT. look crossover summarizes effect cramping Slide patients designation FLX-XXX to can per advance the X, the are of the slide. data the rows two and expected and of in both cramping first we protocol. on ALS the the drug on periods see development

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Tom? XX in designed dose results. in enrolling in This scope trial a data patients of were have reported the of which and a frequency. The identical design treatment The The Patients cramping patients is three but the using our Australian PGIC, and Patients Xb a compared outcome, Charcot-Marie-Tooth which studies those is years readout over CMT treating receiving Phase is evaluated times reported knowing PGIC high X see or in important in XX.X% our Consistent also randomized ALS and improvement Phase who focuses times of a improvement a slides. cramp patients quality FLX-XXX control to few our ask has of frequency endpoint commend feeling X blind days on to who Officer X% deliver clinicians neuron treatment CGIC improvement frequent goal is will was double size, Slide endpoint many no Tom changes the data Phase compared and US the an including I'll then pain, the can that subjects period the exploratory the of data also treatment group. two a from subject to patients ALS the secondary with of XX% now example, patient's well-designed run to for many of quarter ALS and just to Wessel robust designed kind number Commit of disease in on Commend day, in way XXXX. of FLX-XXX treatment the that base are X, for from with a primary robust and design payment control. For following much days. suffer trial of three was the approximately course a study of evaluated the FLX-XXX design CMT in ongoing studies neurologist motor and the reported cramping. from next X receiving from which be third in provide reminder including smaller parallel includes XX were controlled, timely is blind as is on a line be spasticity. The Chief perception in encouraging. FLX-XXX the run XX periods, a in to related comment controlled administered and for Medical, these advantages trial establish milligrams with patients. trial randomized manner, we slide XX cramp design and XXX placebo deliver to which And with patients between essentially is endpoints clinicians day evaluate our trials of frequently larger recruited. cramp data following parallel longer milligrams for will higher This population consistency the XX% currently these and in

Tom Wessel

neuro we Thank was number on in develop patients believe signals be to that benefit suffer to from debilitating and drugs, with into able ALS while Razadyne, these you, starting will Based at many I I Lunesta muscle that others develop painful will [Ampera]. help but career fortunate numerous successful I've Bill. a to a [indiscernible] strong been my who patients expanding drug cramps. and of FLX-XXX

activities for sleep poorly, cramping life on patients cramping. unmet of to both. reduces drugs to majority discussed of this approved living off approved these significant all pain however neurodegenerative medical work no label list have or and felt majority There address used for threatening for responsible with forcing have from X and ALS different be for these we A control before of by United X side medications interferes Nearly in life for treatments seek therapies cramping the the to progressive disease. that report effects can As number symptoms either rely the are quality patients patients Slide some are and need. appears cramps daily and clinicians which causing on suffering X. States them their the of the Slide of the cramps Cramping of

who slide for and and come clinical have fast obviously ambulatory. drawbacks. treating modestly effective as this and All designation considerable ALS can cause options to I And seen is for and patients are benzodiazepines with the recognizes for imbalance Both Quinine struggling of reason. both ataxia dilemma think and [indiscernible] FDA this and available the track box cramps be the highly black remain which warnings on safety us mexiletine may FDA here. challenging sedating granted today

Spasticity the progresses patients tolerated am in disease. ALS and next spasticity data literature to been of MS FLX-XXX XX% experiencing or of experience Study safety excited FLX-XXX with Australia MS quarter GI transient roughly date severe Exploratory of number well spasticity XX. both about terms which and On patients slide late subjects healthy only with coming reports effects. our from has mild the with moderate that In first in year. XX% about The I

than counteractive patients times more For Compared ALS that spasticity, In reasons even electrically neurologists. ALS more predict and would cramping. these for only in treatments impacts cramping FLX-XXX life where data at the human tool suffer induced than quality of today. MS reporting are models, the specific more many with supportive we XX related effective spasticity both an there to that extremely the spasticity associated valuable cramping patients and comes spontaneously a are from activity from for activity MS have data the the of humans we population giving from data

Tardieu stiffness, While not the patient Ashworth treatment the to a show scales does and Modified being did in assessed anti-spasticity evidence in by spasticity provide reported effect of data difference. respect NRS scales

enrolled to improve the the the of had would better opportunity compared note relatively This spasticity MS the MS spasticity. a ALS ongoing of study in these a to Australian spasticity potential FLX-XXX level patients we in that low However, being study. provide test burden population higher to incoming

crossover improving in with So, while interesting. study study and exploratory than for look activity efficacy, was the could liquid formulation rather be designed the MS definitively a results a to small is quite spasticity

this what initiate X is would supportive, Phase study. exploratory for trial If a quarter XX we find first we the definitive spasticity report the plan to enroll in Our in a data larger and are then subjects of and XXXX. approximately MS IND study separate

and illustrated resistant indication slide electrical resistant spinal facial and ion neurostimulation, inhibition and depression and reset the AX activate the on is stimulation FLX-XXX the repetitive treatment cluster a vagal, levels is on neurons and chord shows cause has to channels a and mechanism alpha-motor VX of selective to of glossopharyngeal applications elegant that with its a more year the believe headaches most potential that the this As chemical potential for reminder, TRP nerves epilepsies, neurostimulation. mechanism of but We blocking XX, recently a and descending cramping. validated chemical XX Slide approved slide, on treatment neurostimulation. in similar which other way vagular as uses firing

the XXXX at or normally study well hemodialysis via of to of this potential the are dialysis studying receipt important technology difficulty sessions. looking patients far as exploring during impaired proof-of-concept for number expansion in of just just or in slide INDs achieved who help of ALS cramping nervous milestones We including to agreement we On population as submission ALS neurologically in I of be between track fast FDA have its designation systems recap excited mentioned. thus to a experience XX, number swallowing the with proceed cramping our that functioning a dysphagia and

hemodialysis new dysphagia areas initiated in it including in as nervous readouts. potential an you functioning look renal revealing trials XXXX back potential disease step up in dialysis large well expand have chemical have in definite with We year first And in into share of unmet those to this patients well many the possibly our then I’ll the to as as to system. important disease during that, with or stimulation evaluating Parkinson’s normally are data setting with sessions. of ALS to need also to the hand patients of neurological today impact lives data of in a ALS our technology as Bill. be nurse we cramping The between important We forward with technology stroke

Bill McVicar

City our three to quarters on XXXX exceeding testing $XXX,XXX results we hotshot way our Thank press the refreshed of hard and well look I $X won pleased brand so congratulate that and her. morning yesterday. an the repeatable who business the third we revenue know revenue work years Sherlyn We forward in that We Tom. our a define the year. this marathon Sherlyn the are before with has XX you, paid women Flannagen model. reporting with XX to now slide And York we hotshot work marketing million potential The $XXX,XXX a through just the Sherlyn target hard use of likes the through to summarize do first just like also consumer and business of expanded On for American branding total quarter off. all proud of consumer are is by to ambassador release. in hotshot we’re New and

back which into based that carrier cash early current is turn our approximately operating call As our of to will September $XX balance XXth, With million I Elizabeth. XXXX both on plan. the

Elizabeth Woo

Thanks Bill.

just We portion asking the to go the ahead. and Thank will name the now open up affiliation. provide you prepare their for to questions instructions call operator Q&A ask those that and and I state the ask and will

Operator

Instructions]. Mara Cantor And [Operator from Fitzgerald. is question first from Goldstein our

now is open. line Your

Mara Goldstein

the terms where much have of what like not. onset patients just TE-X Great, recognize for any a I’m I looks study question. thanks the might It information scores. and number do of very but curious CGI are you of you that On taking again and in small about these have the in action

improved looking more SKU much opposed reported minimally the of or to towards as improved. at very much Just outcomes the

Bill McVicar

your Hi, for Mara. question. Thanks

than I week at to I per week data point of that think cramp of day And seems impression free statistically the look better my would one. the only graphed make is out some looked days. slightly observation cramps that the is treatments while that longitudinally, two significant, not it’s we to we’ve and

the or know So, the have whether of what that it US drug, this will in a to me of studies I true building treatments I makes effective enthusiastic but our is the sort we four-week don’t know produce. that the accumulation of see ongoing do

Mara Goldstein

off also what from [indiscernible] sense that you terms prescriptions the like cramps not? in and and can label things off a of perspective written of ask, of for research just if percentage are have and used I are the not, for cramp And could or what absolute market drugs Okay. alleviation what number label that

Bill McVicar

far as for as us sorted do you treatment of No, could burden you number kind that if the Quinine, know get to know interesting – very question treat I course that the of of I those is of Mara, it’s to look What by at the they malaria. to exceed hard code. kind well data we an wish expect need would of that scripts that

that extent with that’s warnings products something these all an significant little used in the are the even indeed safety So, to the being US.

Mara Goldstein

treatment On patient slide XX, there you repeated would the have analysis were What were disposition by meant population, four three that and included. is exactly not subjects?

Bill McVicar

was the an at during sites the what second period. to that happen the subjects first pharma Yeah. there was which Mara, treatment receive those and To caused same error three the clarify

to accidently a didn’t over treatment. they get new crossed So,

placebo So, and they the part in the or got second first of active crossover. the both in either

Mara Goldstein

that’s I’ll questions. else Thank right, you. to wanted just I step ask that. thought. back what All Okay. somebody confirm I let the and But

Bill McVicar

You’re welcome.

on view of of active us opportunity one one to to second response actually in the it’s same some so the of patients pretty that, in gave just the type comparable, more gives to relative is comfort the and us the was that So, the our see And period treatment which first response Mara. treatment trial. look follow of part design second and relative you crossover. set the That first and up patients period actually at a consistency the the two of patient placebo and unique

Operator

you. Thank

Higgins Michael Capital from from is question next Our ROTH Partners.

line now is open. Your

Michael Higgins

notice eight if variability If in per patients difference I pills would day, results, to that was any is on helpful look be understand to hear. noticed there any results the at, could I of but in the did ask you the you there number that

Bill McVicar

Yeah.

everyone especially few is these higher activity. treatment too patients B. little tell treatment plans of think of Michael, the and to three look is a I you bit times BID dose the day to that was the studies new can nail see sort be hit to – our milligrams, that with indication you I on treat for there even at versus a at data just we you way signal a that look set getting clear you’re when there XX a I A, everyone an seem in at as able so to mixed head

Michael Higgins

difference be pivotal results. how of bit the thanks. pivotal, the the that the be the trials, What so adjust effect to if in hit that for a broad reach mean, potentially in a will and and will there's difference you looking median big those of Also, the would trials mean a FDA design between a

Bill McVicar

And that were non-parametric reason that analysis leaning the kind using was slides used of is medians medians that the that the a population mean have source Michael the small The you when course the of reason to we to analysis patient of both you sense a give do in those analysis in compare that was are put numbers direction. it ranked those these you Wilcox and right be want a order able to analysis data. of in because

you So, this of analysis again acceptable would in data those we for that that for types pivotal and think median of be as type would a expect an use always a I well. those set of analyses trial

Michael Higgins

you cost those Okay, thoughts on the for that's is here, for your helpful ongoing trials. can what trials, us your an update give ongoing

Bill McVicar

it say of XXXX. we've in that those given the data we third specific I be will the don't quarter XXXX coming think cost of those into and about early to but are funded trials guidance suffice

Elizabeth Woo

our is the And share trial. investment the in of lion's

Michael Higgins

MS, the decisions run announced you be ALS? over trials renal dysphasia. what Right, those those dialysis, be right, might What others for drove question conduct trials, besides in last and me CNT and quarter cramping to would and then

Bill McVicar

great That's question. a

the about our this chemical we we that technology look restricting of make thought to hyper different investigation for potential and example we wanted the just active that weren't potential stimulation we groups all I of and the could sure thinking be think muscle. of when skeletal at to the muscle neuro of

and increase that with there that dysphasia where indeed a with example thinking internally was advisory data already together got dual indications cramping found in of we the molecules about for started researchers and is that leveraged scientific actually like similar our not have acting we swallowing literature pharmacology endpoint trip is So, and a board group elderly. is that activator a can some shown our

for normal that this a data can try another nervous a extension cramping of say a nocturnal So, unmet and we know cramps intact in these actually that patients this then medical potential and of we gave in okay, to dialysis preliminary interesting on system we that great to And so real normal that systems us induced electrically both and technology technology. we to it the have renal would leg nervous would thought need thing and us that patients affect and here's the is chance in to success some predict cramps be natural try are on. the test have seemed

Operator

next comes our from And Jefferies. Instructions]. from Roger [Operator question Tung

line is open. Your now

Roger Tung

congrats and data. you Thank the on

So, related study. I the a couple of questions have to

intensity the stiffness So, the show I of reduction have the pain the you the see the saw or cramp percentage and associated Do of reduction? number we significance.

Tom Wessel

numbers I basically can that don’t reported the slides think see on X Roger. we but slide the on it you

things. are look intensity I over is So, pain then painful it a can the And the the are me It’s and a one in back left, mind painful. with is that treatment. is much remember associated keep ones see period decreases are we present, that this of less let the the not trial the how us pain the cramps look And for think improving actually we still that’s that most that improving to general important is about make that number cramp. pain two measuring the at of drug pain ones in still just is reason then just like are which This baseline that you time. this comment on and

kind the a study. we are this effect So, really two-pronged that with measuring in of it’s drug

at slide that data the then of amount the you did sort in run So, and X, on the look that it treatment? decreases find during

Roger Tung

this have find slide, later. Thank I I it. you. did Got not can Maybe it

Bill McVicar

Sure.

You want them.

fact that in patients that’s increase we benefit that bit, this these think that expand free. the to many a free upon and they having of to days, frequencies increase So experience cramp see that cramps that the an where lower cramp suppressed a the cramping related then fact is entirely day of are have whole little have I actually an just of

Roger Tung

The very free cramp Got data it. Great. encouraging. is

some the use So of drug cramping, in off-label have next question Quinine. so kind we know we

you do public anecdotal data and say, efficacy -- have So, our some XXX? compare how or data let’s do how those of they to the data, what’s

Bill McVicar

Yes, we which of have data Quinine anti-cramp from is the I mean studies at a the still by different looks of Database drug most effects the know Cochrane actually with lot as seen across you number a and used far Quinine worldwide.

over to you UK, give are year. data million a still scripts the Just we one X today point, in generating

an We on States United that’s course script the in of XXXXs similar the of use So but number. and Quinine. FDA the then XXXXs the late levels down enormous clapped had in

was States, through forth. it it broadly internet So, used and in many pharmacies the just United so received patients

the despite off box black warning. it using label So,

Roger Tung

effective in Yeah, Quinine how patients? the those is

Bill McVicar

remember Well these if studies at actually you so order the very X.XX know across is about effects I you if on various it's of look correctly. the small,

that you can you send and data I’ll You like. up if look that

We we neurology conferences. upcoming will are report here seeing larger and sizes are those at substantially that effect

Roger Tung

Correct. Thank you.

So, variability. so mentioned the so question, see I that apply my you last not you interim only think will

this from you commence you other So, study? to what learning think apply can study

Bill McVicar

a the behaviors. robust have that think subject a I and that about really treatment give is is consistency going this data cramps again in times other thing The a behavior look to between four-week good. is at say would is times fact just I the one week. XX variability there And with subjects, actually think I cramps pretty what the encouraging longer cramping may commented that the us XX four-week I you despite set treatment, is very that one which those high a run-in on think the week patients Well is so that I week-to-week cramping before their

guy you in and XX is where power studies is guys that of to of of every and these would with is surprised we that own and out up these what the patients. means that bit. means sort So, their a living at designs I so of baseline, see down is XX patient that’s really types think XX is data that’s eight lot that’s much a between in study were the What that compared these why with just that bouncing can get we XX and

Operator

time turn this I’m the At remarks. back questions. to over further I showing to for CEO like no Instructions] [Operator would call McVicar, closing Bill

Bill McVicar

you to much. the thank I everyone And just I their good for very and you Thank to updating our forward their joining look today future. Thank in you. interest questions. in wanted for

Operator

and Ladies today’s now gentlemen This for thank you your you may concludes program, conference. the participation in disconnect.

Salarius Pharmaceuticals (SLRX) 6 Nov 172017 Q3 Earnings call transcript