Salarius Pharmaceuticals (SLRX) 12 Aug 202020 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Salarius Pharmaceutical earnings webcast and conference call. [Operator Instructions]. I would now like to hand the conference over to your host for today, Greg Siderian of Tiberend Strategic Advisers [ph]. Thank you. Please go ahead.

Kelsey. you, Thank and quarter everyone, for today's joining Good and thank corporate second financial results XXXX afternoon, you call. XX, X Earlier this its ended listeners the detailing press a we June to months read. afternoon, Salarius financial Pharmaceuticals results issued XXXX, encourage which release, for can website. press salariuspharma.com, release News of found be The the in section their on also at sec.gov. and Salarius -- this also website the XX-Q afternoon, their which It's filed is available also strategy, including expectations future seclidemstat, about Today, and we future statements statements will about cash and events and capital forward-looking of our be development and expectations, circumstances, operations drug, the our regarding making plans, investigational resources. allocation certain lead our our These expectations, on and statements undue current reliance our these place based are you statements. should on not detailed filed Risk Pharmaceuticals, SEC in of Salarius Actual with the we time. with section the risks results may differ those due Factors XX-Q materially and time to the to make other SEC from filings including and uncertainties, update a future forward-looking any these information obligation in Pharmaceuticals otherwise. or events of Salarius result to disclaims contained as new whether statements, information, and Salarius' and is Pharmaceuticals, update provide On today's achievements will who the Arthur, on Salarius of Chief and for future. vision the David second Executive its during clinical quarter corporate call Director

Chief quarter Rosenblum, back With Mark who have Salarius' David. Officer, second you, to also We I'll turn review XXXX will results. financial call and Financial that, the

seclidemstat, by candidate solid transformative sarcoma advance the to highlighted advanced Capital is today. you, time our our for stock and Greg, important XXXX, Thank company entered achieve tumors. on corporate and debut for Market. completed XXXX thank We with for programs drug in milestones for publicly investigational joining an lead traded important This positioned a NASDAQ Pharmaceuticals. the you Ewing conference listed call as clinical well everyone our to Salarius a We've our

ODAC, weeks quarter of In Pediatric and Ewing of brief will advanced broader compounds. by FDA's our presented to Salarius, Oncology Subcommittee June, the The value early seclidemstat intellectual U.S. we the have only Oncologic X-day second a XX events drug all substantial a of for patent a seclidemstat. protecting the virtual several demonstrate of abroad, Patent validate of growth holds as the to and known Drugs Advisory property makers be European strategy of driven progress research the during time Committee, issued in and were proven in by I also the that with even July, now, most plans portfolio participate recent an In more XXXX X and discuss strengthened ahead. the sarcomas. to quarter report. of Ewing to biology which seclidemstat population. This develop believe also Salarius new Office. to meeting ongoing sarcoma one all, issued the meeting. we we are similar And in share that expansion well detail ongoing structurally known as provides for as a to announced Ewing's, call for over to you sarcoma second recently, expand solid in right with Salarius Mark, in turn a Mark directed of bit. Ewing financial trial as seclidemstat include in similar its trials the like review to I'd to Salarius' a opportunity or seclidemstat trial But patients the the clinical sarcomas patents In of the Ewing's-related clinical tumors patient go Salarius

Thank you, David.

Salarius $X year, increase or into primarily XX, general X $X.X and of due million a XXXX, and increase operations same increased $X.XX an last increased for income manufacturing loss for expenses clinical trial which costs. by development research XXXX, months net net compared the share ended expenses recorded resulting drug in reported during million from Salarius by diluted from lower $X.X June the $X.X $X.XX and was million and same the operations diluted the loss public share basic to period increased the Salarius' other somewhat the XXXX. in in before administrative compared million and loss also from compared of personnel of period offset same expenses the $X.X per and from million a in quarter, June to The for to loss net a XXXX. transformation current professional of XX, basic per ended For costs company legal period costs period X-month a resulting to or fees and

As This million cash me, $X.X a compared XXXX, of of not, of source latest was $X.X excuse the our ongoing Recently, Salarius' Salarius year-end funding company. -- million, offering Salarius paint not total accurate on public cash of picture million from This August and XX, to however, is completed financial its X, June clinical of Ewing's-related XXXX. does intends operations, at fund Ewing $X.X the resources the to only expansion to the XXXX, equivalents stock. capital. the proceeds to $X.X and an million other the trial to use underwritten include sarcomas. common company offering sarcoma available

up interesting of of grant our have the meeting we CPRIT, $XX.X story subject available In requirements One which to subject an to at as known million genuinely the Salarius capital the also certain disposal. from the aspects Texas, of contract, $X.X approvals. or Salarius we under million have of XXXX, to Institute CPRIT nondilutive -- of amount certain Research Cancer Prevention is received the still and

the to from studies. funding fund Foundation Ewing Cancer our Pediatric nondilutive has sarcoma National helped addition, In

that, late return the sources, programs funding resources to XXXX. the to tumor various believe financial With has advance Salarius and back David. sarcoma to call these With like Ewing clinical our solid I'd we until advance

Thank you, Mark.

we about years. bit forward few with can look the what's over little next a talk to Salarius let's and happening Now what

of battling patients cancers As we've is investor discussed, our and maximize maximize world to hope gene return. the by potential goal to around the caused dysregulated seclidemstat, expression bring

market trials clinical remain preliminary seclidemstat. advanced clinical COVID-XX advance patients. for profile with dose-finding a in outbreak, trial objectives out look designed our XXXX to continued tumor advanced characterize actively characterize and and activity. sites. during have we including and of seclidemstat are programs rare tumors current To safety to priority with as where Ewing solid the open-label clinical the secondary is have studies X could recruiting high both fighting these not maximum at Both other all the believe seclidemstat sites studies tolerated the also enrollment establish review, expect primary objective beyond, dose A significant our the we assess over the pharmakinetics, antitumor sarcoma trials and opportunities other to solid a sarcoma, with As Ewing impact explore cancers. remainder patients and XXXX Ewing's-related sarcomas we and only pediatric but Both of

the This suggest are clinical escalation or data advanced and manner no plasma pharmacological as plasma continuing Now, thus exposure solid of both trials plateau trial Ewing the a studies. at concentration levels the the or sarcoma seclidemstat during early to important levels a drug in levels. is proportional from with that is dose of and Salarius in activity now was seeing noted increase patient's tumor where above continue far, in preclinical evidence a in trial plasma news drug levels patients dose

with failed not standard-of-care On patients previous that seclidemstat patient year, X July who lesions in and therapy completion sarcoma which treated later determination largest hope reduction therapy announced had a target months, the refractory tumors. a we single-agent represent a was prospectively lesions. XX, and patient's Ewing defined Target for demonstrated generally in we measurable in Ewing only complete we patients dose with but dose Following expansion dose, sarcoma, escalation of plan maximum this Ewing's-related tolerated sarcomas. also again to of to with

of and progressive However, increase as weeks, nontarget unfortunately, in or at defined as patient disease designed -- Solid resulted Tumors X Response by Criteria lesions the overall an classification Evaluation in RECIST. an in

clinical with number a and to that to reduction dose enter seclidemstat this represent observations, be treatment Ewing-related of to to XX either additional We phase activity. in to target We clinical to rearrangements, the Ewing therapy. this seclidemstat believe for other enroll to expansion investors. XX with include research the dose Expanding to we by will of Once cell for Ewing that phase will enroll this Now data Ewing-related it's seclidemstat amendment preclinical are family the and as seclidemstat demonstration a or the supports trial preliminary Salarius desmoplastic up from ongoing defined of potentially important. develop phase also sarcomas. this we small myxoid an FET, This decision potential, demonstrates the measured Ewing's-related from patients potential for sarcomas sarcomas. opportunity is in sarcoma mentioned broader is cohort XX maximum established, will expansion to expansion I made of expansion believe Ewing-related patients round sarcoma even can and program with single-agent also current increase lesions expand second known prospectively is the the that all activity, benefit that as We planned patients drug sarcomas treatment an believes the drug believe why which good under clinical including seclidemstat and by trial cancers share sarcomas. Ewing-related patients gene up our patients, believe treated patients tolerated coupled population. patients of a is patients, patient tumors good trial also protocol, as XX liposarcoma, earlier, for the with the Ewing the trial offers include

of sarcoma trial, with including expansion sarcomas the data XXXX, both the in disclosures initiate to half early cohorts half expect the Ewing Ewing-related We from first of XXXX. of second in

sensitizing a available tumor we cohort our potentially genetic that patients commercially mutations. we Salarius. opportunity roughly of are designed to profiling solid an trial an immune checkpoint These or in in in epigenetic and addition XX% SWI/SNF is ongoing in or to tumors on exploring and/or with clinical transferase potentially mutations occur believe more mutations a enzymes cells. enrich the have to explore in enzymes represent and solid in immunomodulatory unleash for screens, complex of mutational expansion antiproliferative these significant the advanced complexes cancers of cancer type Further, using By potential immunotherapy advanced identify that becoming harbor could treating the in seclidemstat may in of with treatment solid we other Now the of attack increased to effects. can LSDX common with mutations combination mutations This methyl acetyltransferase epigenetic patients. sensitivity use tumor opportunity inhibitors, in type seclidemstat provides and an or

a do Now while advancement in cancer, the they treatment not in remarkable all cancer work patients. are inhibitors of checkpoint

who some to -- an inhibitors, a who addition, return the do inhibitors and not initial experience of response disease. to do refractory In show checkpoint patients become checkpoint can among patients these

carcinoma. These immune hypercalcemic system In immune a with demonstrated may in tumors and a in cancer ovarian checkpoint represented ovarian paper of turn identify. specific inhibitor of immunity to vitro July seclidemstat terms, to Arizona we paper antitumor Research ovary significant that of system considering the Translational simple in in checkpoint Genomics tumors cell investigating able types into this were peer-reviewed X. then scientific is the X these respond that believe studies, cell cancers infiltration and clear a are These published Now that ability This treatment. in concealed Plus hot types at inhibitor. We opportunity, type both seclidemstat of promote and carry year, Institute small effector tumors this cell researchers seclidemstat clinical that a journal a from trials could of T patient's X carcinoma potential the the cold is to mutation. studies combine the

cancers. for seclidemstat's blood Other are hematological exciting potential attractive to LSDX Another we LSDX indications inhibition. hematological for inhibitors as validated treat or have exploring cancers area clinically that

believe types allow certain for we of diseases. advantages these treating differentiation may that However, seclidemstat's when

excited our trial and malignancies. be with in considering seclidemstat hematological are to clinical development seclidemstat There's about a studying We programs. a lot

already the the turn, These our next have of from In In including anticipate and several in data remainder we positioned on XXXX, Ewing past substantial. tumor beginning Ewing's-related for quarters. since fronts addition and number accomplishments of all, additional months year the and a Salarius progress to potential early the clinical number we this certainly, the a sarcoma throughout X sarcoma, milestones is of have advanced made year solid the disclosed, into over growth have, we the of trials. over data

now President, would Clinical Kelsey, Now Mark Vice to take and Dr. that, I Senior and questions. will me your address open call joining questions of the Daniela Santiesteban, Development. like Dr. With to Director to is and you over? Development; Business Research Nadeem Mirza,

Aydin of And Instructions]. [Operator the The comes question Benchmark. first your line from Huseynov with

companies we about combination progress IO, seclidemstat on to you Congratulations trials with most combination your these trials? sponsor interesting are the opinion? the immuno-oncology this what quarter. think expect combinations the And When would in for

question? that take to like you would Daniela,

you Thank question, the for Yes. Aydin.

as CTLA-X data, what companies advance combine in with inhibition PD-LX, LSDX so and be far think that our checkpoint So the research larger we has well would these do inhibitors. programs that PD-X, And is seclidemstat shown generate more that interested. particular, preclinical and even would pharmaceutical we

that remain the refractory subset checkpoint know, work of well but or patients portion in you patients, of inhibitors sensitization a As checkpoint to inhibitors. a large lose

And like is help a open or wide inhibitors so an either checkpoint market drugs sensitize there resensitize. -- can seclidemstat that for to

Daniela. you, Thank

Sorry, Do you to the company's for immuno-oncology the yes. And sponsoring? just companies combination want to large -- immuno-oncology your -- sponsor expect trials?

is David. this So

possible. want data that's we that like think begin we available pursue. to to I in put when the have vitro will those additional would data to together something very case certainly that And most Salarius and vivo in compelling discussions, much

field. checkpoint looking to with certainly leaders the inhibitor in will we So partner be

I appreciate that.

got one target prospectively with who Another is, the patient XX% decrease about lesions. in responded I question so defined

the do why if a decrease systemic not think nontarget lesions seclidemstat even did you is So agent?

David. is to Mirza that Nadeem, you would this take Dr. like So question?

lesions. mentioned. Nadeem total described, response David of the is actually, it referring And is The they shrinkage the all because and in clearly we This which resulting disease. drug, the lesions, Thank you targeted lesions, some saw target sum target think earlier number I an of that targeted And we in to, the there are have overall, you lesions. the Yes. the you're in saw all the nontargeted alluded for that, progress. we was of of that progressive -- nonmeasurable, Mirza. the a activity lesions, all considered to What the But patient question. were which

Got it. last Got question for it. And me.

inhibitors in hematologic advanced solid for in in IIb one to in broad tumors? opposed irreversible LSDX myelofibrosis malignancies Given is AML. and the you opportunities competition largest seclidemstat LSDX, do Phase I the most think and the think But general are as in

I'll make to any So comment follow-up this is David. make and then Dr. comments. a Santiesteban perhaps ask

number a opportunities available are seclidemstat. to there that think I of significant

As we market, to -- patient you of Followed a just area Speed we as with development sarcoma, of two-pronged Ewing medical areas unmet or have concurrently seclidemstat that huge the have need. approach. population. with know, discussed the we've will is in development which an publicly, expand

your of the treat to understand biggest and think think to the we with Now highest unmet question, and put point that medical will need us opportunities first direction drug. this for in time, can those if I those identify explore take I best most areas naturally patient at seclidemstat in areas we patients, the valuable and the the how of

and this think which exploring So identify for to advanced able therapy, tumors together are patients -- we inhibitors allow be benefiting. our solid provide trial, not also where we number but but from of opportunities to strategy, inhibitors cancers may in in with mutated potentially the at only only at patients we're looking sensitive to malignancies a potentially mentioned, with benefit tumor clinical being benefiting mutations a combinations very what LSDX not seclidemstat potential recruitment are tumors time, And could not strategy. a also across checkpoint we're who would strong, as more hematological exploring put we that we currently commercial begin solid with is checkpoint

and front So if be. the at it's get right to might answer. think difficult anything keep like add? we'll areas do of we have to the need, I the pursue biggest center this opportunity point, unmet But patient you'd Daniela, greatest I what you say to think, and

their door the seen to shown activity. And lung has they're differentiated scaffolding LSDX a a opens other because that, we've types inhibit seen like and maybe Yes. I'd cancer. where a to of pursuing Seclidemstat LSDX's as activity activity. action, not ability pursuing of the a right, us. indications in small have not that other those activity inhibitors drug inhibitors only And thematic lot where well has that's We've shown function. also cancer are LSDX but mechanism up add cell to heme of just where lot as you're

is just So whether your solid in LSDX may potential or other can that like need what heme answer, addition in. help guide, also you and show they how molecule to David's to tumors I'd be you inhibiting understand indications, add that to that

your And Ladenburg. Li, comes Wangzhi question next the from

Li Wangzhi Ladenburg. is from This

must discussed, the it about of think expansion the question I but trial have a be the I question you sarcoma. Ewing-related a in

explained already You the rationale.

trial you -- Just you wondering to cohort color add if still combine a X if supported the going preliminary forward, activity Phase if you just data both And you I. or II, for more about the regulatory Phase separate have in the for Also, Ewing-related in provide expansion to Ewing going for the one and drive -- the to to the patient for sarcoma? are you approval see cohorts that the expansion. then

Dr. for questions. Mirza, start? would the to you you Thank like

Yes.

if So cohorts two the into or understand, two to one was have sarcoma. to go related you Ewing-related the have prompted I one. X us second what questions, And whether we'll

that ongoing tumor actually some patients also We advanced have gave trial some us sarcoma enrolled an solid evidence. clinical that

And part preclinical to addition so data one was supporting. of in it that

was the to rationale add the that cohort. Ewing-related So sarcoma

Your second combine whether or question relating separate. to them we'll

may on short next what -- to then we or will then observe, different trial some the based But X would importantly, expansion in then safety, there Ewing phase, further XX will earlier, And be David early this and as define activity. And there have have XX authorities cohorts. that sarcoma will allow to step. with expansion sarcoma us to health Ewing-related be discussion we discuss the patients, patients. Ewing the the see we tolerability, is mentioned will conversation but be what any will more the So answer

highest color the you your helpful. dose to report? until to it. data escalation, That's going the continue timing the reach From Or dose would MTD? you is, are for And stop question you at Got dose? maybe any on last

Yes.

So can that. Nadeem. This take I is

So out we cohort X X. at currently are or of dose X level

tolerated recommended of dose We will first initiate by next this end dose expect to II year Phase year. maximum our get to our which half expansion cohort we of and upon in

Research. Diamond next line And from Hunter with question Equity the comes Diamond your of

Congrats recent on the the quarter also financing. and

So one of but some have my answered, more. were or two I'll questions

want for investors second the it's happening? an a in just know the that? of to hematologic as sort or to sort And for inform of half, you're anticipating what indication. backing maybe we update I it Is preclinical? talked early going What's to that the then data that days the trial strategy So just I get be that. an And on

David. is this Hunter,

me Let color provide around ask step that's to in a the preclinical some available. in little and I'll your information question, to information and Daniela fill

So that we hematological has about we by in in even to moment the and a is approach to validated in ability -- we in to been greater about reversible seclidemstats of patients. ask that that may have further what those are or And we preclinical Daniela talk we that or let setting. believe moment. currently her provide know feel a talk inhibitor disclosed the that I'll us allow this the a also cancers other benefit inhibitors, that LSDX as one differentiation And

would in that So and this fill a that data to and some information into preclinical a we that to to year, not announcement. cancers we're opportunity the on sometime pursue you We make trial to clinic. to the later but preclinical hematological prepared data? clinical Daniela, like in hope yet hope translate knowledge the translate

Yes.

lines. heme several within different So seen good we have cell data

effects that anti said, published SP-XXXX, AML across collaborators well-validated and we've by As have published this space other our LSDX first-generation compound inhibitors. lines. proliferative David is with has cell it But or

it in heme ability showing and have the across that well effects our internal like activity cell as lines with to see several compound data increase also as differentiation an CDXX. different seclidemstat markers induce or has lead anti-proliferative We SP-XXXX

this as have space. why, we that package a do nice there. later So we're David to data said, excited And an in that's announcement make year

next very question IP perfect. is around just Great. the No, portfolio. then And was my That useful.

or and does PR, patents many there how think patent. know an So and European the announcement -- I I was

And you're some at patents of how do sort do going many that feel point? this the have they to -- more or you using or Do fees? then So you seclidemstat IP of for do composition? you feel be these it's efficacious of if feel methods that has company that company secured use legal does the -- proceeds

XX that seclidemstat So cover Hunter, issued or compounds. currently around that world structurally patents we have -- similar cover the

currently patents out in the went approval X around We additional in press exactly and in have process that that it's can't that we release world. you. for remember the of get list certainly countries And can the but recently, are I countries, the

patent improve strengthen other to defend aggressively forward, method and that we of are represent through our we portfolio constantly portfolio. it and where can Moving use and additional maintain areas patents looking could the

maintenance our and these So of your to of is protection answer question, part operations ongoing patents. the

will funding So yes, some patent go towards of our our protecting and the funding future ongoing certainly portfolio.

the or much a it's although -- everyone, lot defend. industry procure, and than are Makes obviously, off everyone patents useful And of they're Perfect. the biotech, to software can very sense. in probably more something, much right, knock hard to where expensive

mean, So I doesn't So be will efficacious, the biotech, right? the enter patents pharma market. just it's big critical, the

on So okay. and all of results in financing. terms I again congrats the have the and That's questions,

question, participating. Yes. for for the Thank you thanks Hunter,

with Peak Old comes from line Patrick Doolan And of next Road. the our question

quick the just All it to happened question. as disappointments? or a better have than anticipated, date, anticipated, or very clinical I has been there work been have preclinical that's

research, the know don't we're Patrick. of by Well, we nature, that the answers -- -- thanks in we're question, get. going when business It's for the to is research

we Ewing-related have seen And will target clinic activity the so that into -- with. of a I the study Ewing have based we on results recent our fact point of we pleased reduction expansion drug the have feel that with very in to trials demonstrated experienced seen lesions. we we're

seclidemstat in be benefit suffering could can cancers. fact preclinical studies X -- have discussion -- a in real we real -- one -- patients identifiable identify the that mutations with those therapy X in mentioned mutations, the the very have -- have today, in of can potentially patients benefit We need. with suffering unmet from The that a study, cancers, ability high

news. again, very positive So

over really We the wanted not where what have just where us to also the that's we seclidemstat years pursued with areas found seclidemstat, It we are to have see. many, think those of activity seen drive was benefit be allows that And as and many pursue to and to the going as And valuable we've areas. areas we the success us focused to get activity Salarius. areas the patients. most of ultimately

to answer single see your short all. of the is, one it question we So And the we every learn from outcomes.

Okay. that But actually Is seeing my you're you're positives overall, impression the and expanding is, correct? scope.

is ODAC, saw That by asking largest prospectively patient, had higher the from by of literally Yes. thank data you the the we're measurable number And that information think this may We The interaction we at we increase the so with saw at that, to XX Ewing's-related for -- we question. be We physician, we pediatric information this in from preclinical sarcoma populations treating -- feel coupled the that the felt XXX%. that's And went to information feel study. seclidemstat. up generally And that is really in time a advantage that very looking in a patient led measurable Ewing going answer number we positive of opened patients. clinical and of the looked us that tumors and identified follow-up positive what that much decision of largest make expand, yes. the benefit are at XX study the the with to -- is fact all this activity. we it the of is demonstrated positive was to to see take we to point and subcommittee patients the door

say think to I very feel it's -- with that fair seen positive we overall, we're we've very recently. yes, what So positive with

to Yes. it to And came just how wanted I across get understanding. me. that's

your from Aydin And line of the Benchmark Huseynov, comes question company. next The

one question to regarding the the comparison got follow-up in of market. just seclidemstat others I

And think any differences cancer? will be nivolumab in reversible there the Bristol's read lung agent? agent across LSDX So or plus or is there any with LSD you from Celgene's do study similarities

provide Daniela, question? some background would you to that on like

Sure. Yes.

can't about I'm employee, or too BMS a So not speak so much Celgene I it.

But with this may may other Just seen they apply And than well. as that have microenvironment what do the the rationale The to profile their in a be why as do, validation LSDX is LSDX cancer think I been different it do if seclidemstat. pharmacokinetic see clinic. a different have and neutropenia combination, much that's tox But combination inhibitor like thrombocytopenia. why in don't behind view compound modulating as we much that's one trial where molecule, you company where mentioned. profile pursuing in currently clinic the that, a Celgene's It's I've have inhibition in formerly literature. than longer a believe. I now BMS, is this They patient, half-life. they're Salarius thinking we in tumor of advancing we Celgene's, We reversible

the do that targets, same So I but activity mentioned, they have a think we I different safety like differential profile. but manually are

combination like Celgene opportunities I said, has are us. this there for for And So us. validated now

So that. we're excited for

you are further there at questions, time. And this no thank

Yes.

up. this wrap I'll David. So is

is And cancers dysregulated I Salarius financially, COVID-XX just today, is sarcomas believe gene for especially our discussed expression. their hard to -- battling a other strong by outbreak. caused footing to and operationally, we on and take like continuing we believe moment developmentally our to and maintain work Salarius I'd thank to As we we momentum, are work Ewing-related are. sarcoma, our support stakeholders employees to families for this to as their and during Ewing bring patients and hope we continued dedication to loyalty, their and

you today, to extend Thank my I'd sincerest to all. time and for your So like today, good I wishes health appreciate attention your participating. of

for today's Thank you, joining ladies conference and gentlemen, call.

Presenters by. stand may please disconnect. You now