SLRX - Earnings call transcript Q1 2021 | Salarius Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the quarter one 2021 Salarius Pharmaceuticals earnings webcast and 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]. I would now like to turn the conference over to your host today, Mr. Strategic Tiberend of Rando Advisors. Jason ahead. Sir, please go

Jason Rando

can detailing joining Good first XXXX this ended Salarius press for three for solarispharma.com. which results XXXX, XX, afternoon Salarius and a this afternoon, and thank afternoon, release also available encourage in on the sec.gov. release read. The a listeners issued everyone filed March Salarius found Pharmaceuticals to News financial is salariuspharma.com we press quarter months which Earlier be section of results the Pharmaceuticals call. you its financial corporate XX-K and

statements. the first please financial clinical Pharmaceuticals, review and first Before allocation achievements operations Factors make CFO, as result information with update and be seclidemstat other cash on events Arthur, beginning new contained reliance Today, time with expectations information, an the effectiveness you potential the corporate and metrics, of in today's and lead detailed should and making call not to its call, future and following us Salarius go forward-looking quarter the update on Risk uncertainties, Salarius' will SEC of Mark in well materially plans, SEC on quarter future I including Pharmaceuticals' Salarius risks will expectations, to resources. David those circumstances otherwise. would Rosenblum, and of filings development These With provide the these XX-K these whether David, drug and from results our expectations undue current including operating like we any will regarding are based candidate, due as future disclaims our about time. to filed future and the Actual of to and we statements the our place a our who section as may obligation certain about CEO investigational today's differ capital statements results. forward-looking strategy, statements make ahead. events is vision Salarius statement. or on our for who statements, during Pharmaceuticals Salarius'

David Arthur

Jason an Thank all call, you for is are of first This exciting everyone our conference you joining joining time and for you time. Salarius. including thank the who to

of drug weeks our have been strengthening accomplished candidate, The several and and activity sheet. of milestones, programs expanding XXXX as quarter seclidemstat substantial first for period recent key lead our a our including clinical balance Salarius

would is clinical from time. which Salarius new joining Before to our drug I with cancers, dysregulated lead stage like we gene Salarius expression. tumors a patients cancers. enzyme, and moment technology business candidate, individuals review inhibitor results with Institute Salarius company Huntsman take of to play is believed Cancer numerous reversible biopharmaceutical caused developing financial solid key first a pediatric the the the for describe and to was a for other role potential in highlights, to LSDX and seclidemstat, of Utah us founded a is cancers our University by medicines

cell where efficacy trials, models Ewing The are way, Ewing ingredients similar can of address and in Phase concentration escalation a animal right of the wrong the Now additional as in dysregulated are and that of tumor reach there, seclidemstat plasma order. the accomplishments. be that misreading These quantity recipe. ingredients of not profile, sarcoma also incorrect the it sarcomas. that first With as X can dose of cells expression advanced said totally the with and believe the progression. levels observed misreading clinical for Ewing-related and biology demonstrated and in escalation the was When quarter. determined that Dose these scientists, described early the we the believe of another cancer patients confirmed lead We recipe a or established we signs sarcomas those referred good it we completed let's as in solid all dose. a who sarcoma, discuss the across correct Ewing development the or dysregulation we We misreading X/X to recommended share above the sarcomas Phase phase combined to the genetic are can our trial sarcomas in believe or or safety except saw code, in misreading We seclidemstat seclidemstat's can background, Ewing. seclidemstat to additional drug are recent activity recipe. context that occurs was ingredients gene us is FET-rearranged

with more safety and Because this trial and would third administered improves will speed As These we for for of a result expanded distinct observed patient call. more makes easier like pause seclidemstat and to I is for or a clinical of I of continuum that and detail. This common change chemotherapy opportunity regulatory dose in the second is Ewing efficacy regimen earlier utilize cyclophosphamide, groups, of separate highlight market, potential to patients cyclophosphamide treatment patients in into this to a and I later to third or in it which and development are these for amendment to second trial's development and trial, any patient or our stark have discuss the an we first Moreover, stage liposarcoma Ewing treated second accelerated we believe commercial the here treatment Ewing important trial, myxoid a data With to can use want sarcoma. to prong in include approval, chemotherapy want patient where the each therapies. the number treatment during line to FET-rearranged of dose Ewing escalation this a agents, patients third to combination physicians because of sarcoma, represent or change three trials. the the of groups building patients. with have to sarcoma Ewing topotecan distinct seclidemstat the the stage discuss addition stage the in other were potential expansion we amended as therapy, upon treatment without three increase meaning regulatory seclidemstat. through other integrate the dose we routinely topotecan will earlier anti-cancer the and strategy, seclidemstat potentially explore approval course, who of another patients combination Ewing is escalation on receive milestone, as line common populations, in sarcoma seclidemstat, Ewing I the we believe Treating outcome and combination seclidemstat outcomes with the single-agent for paths sarcomas. the contrast clinical Ewing depending, existing seclidemstat line trial initiated in which preliminary and

before two Additionally believe prior with two lines seclidemstat. new also were therapy which treated prior lines and are patients patients dose of combination before Ewing we in one summary, therapy patients of only to addressable in the amended seclidemstat the where continuum and outcomes. in population versus escalation later treated expanding receiving we contrast, chemotherapy, as In improved the will patient now continuum result care XX the during protocol of or Ewing earlier of received in treating stark receiving in care, received patients

patients, increasing significantly sarcoma liposarcoma mentioned patients and seclidemstat' population, also sarcoma earlier, market. to includes including, Ewing addressable FET-rearranged overall addressable addition myxoid the of patient expansion as FET-rearranged other which new potential the populations I trial increases In patient

of Mark in As time the to in see, transactions currently including cash cash combinations. hematological quarter results completing first Rosenblum, We to have with you through call moment, $XX potential other raised Salarius $XX to the commercial during provided by million at have and that activities the to a same ago, position completed I more, go resources trials larger current our seclidemstat than year million. would financial markets, beyond, who developing can the capital speak dramatically. clinical series will a fund over substantially recently compared ahead. its first equivalents. What's financial transactions and hand Salarius our cancers that the capital please our this and quarter to our have expanded and like At completion Mark, clinical while therapy CFO, strengthened more

Mark Rosenblum

David. you Thank

with largely into travel last COVID-XX XXXX. million from reported laboratory $X.X expenses million fees general quarter personnel, and income of first costs. development diluted an share, ended XXXX. professional lower dealt three-months million operations the continuing The or travel to development costs during general increases loss compared are per in to administrative and was loss The a lower Salarius period company operations our resulted of in and due in and in XXXX expenses. one-time For fees which lower of that from measures. than net of by costs. other March primarily from loss basic transformation early net year, a ended before a for compared the $X.X of and and for administrative XXXX, the $X.XX March period share $X.X XXXX offset costs the same Professional decreased the three-month decrease into XXXX loss and increase costs or late Higher XX, $X.X million research per a drug to manufacturing Lower resulted more research from public $X.XX and result expenses in the XX,

the public offering of maximum Salarius $XX offering During this million first of at-the-market quarter year, the completed million. a for an amount $X.X and

gross approximately in warrants $X.X as received exercises over period Texas, first $XXX,XXX Institute Cancer known this quarter. amounts during also took million and million to in of Prevention the from in Additionally, from Collectively, Research and company the the the $XX receipts cash CPRIT.

total restricted XX, December XX, and at to million and million XXXX, cash As XXXX. totals million March compared March XXXX $X.X on of $XX.X $XX.X cash, equivalents XX, cash

XXXX grant current in cash position contains David. on million which to through the I current position, call back current funds completion XXXX CPRIT million fund our to return be a that We our operations strongest is $X.X dating $XX.X believe our of our listed of trials sufficient beyond. original our $X.X as current million, will the to-date, that, clinical balance to sheet. receivable totaling With will and Our remaining cash

David Arthur

Mark. you Thank

end, up component mid-XXXX seclidemstat up to trials active up and in explore three therapy we separate potential To only often, strategy our difference limited is market seclidemstat make cancers to our the families to maximize in patients the As not their markets as for to we three of and by patient populations expand distinct five and also fighting clinical seclidemstat as a the doing hope into development second to Expanding options. but therapies. and evaluating seclidemstat with these to two-pronged in combination have planning agent and of and the treatment to total single mentioned speed that lives trials different of larger a underway so, new is ultimate market. I by prong goal are of

days. earlier, during patient demonstrating appeared Oncology, cycle antitumor seclidemstat poster discussed will poster for this in believe supported of the of the the meeting refractory X.X. the activity. refractory data in encouraging at we also and to disclosed reduction major considered anticancer trial as resulting As taking end patient treating of patients exceedingly Ewing by of or XXXX believe and a with potential third defined When two shrinkage, be version sum accomplishment six seclidemstat treat cyclophosphamide. key and lines, endpoints the of that ASCO. XXX there other line research Nevertheless, seclidemstat Salarius agent Ewing has demonstrating activity. established Evaluation so lesions a in was sarcoma XX% a target Full seclidemstat Ewing Among a patient single makes days evidence potential who clinical early Criteria stage agent our is we this is with escalation or we single next treatment trial discussion non-target classification of a topotecan Unfortunately, findings by agent far initiation, over sarcoma in drug completing this demonstrates the session all that at also as Response seclidemstat. a the observation especially dose at XX We sarcoma outcomes. and the Society disease internal What that of positive lesion tumor in and combination or synergistic believe is preclinical despite American the gathered fact context the Ewing prospectively our believe effect clinical now month new Ewing when Solid after treatment is while with achieved relapsed progressive annual in topotecan known no cell single this and defined evidence a preliminary that including cycle after is second is cyclophosphamide, with combined this Clinical difficult evidence demonstrated received a the Tumors its of

addition solid a sarcomas evidence, sarcomas combination agent in to below or related will other month patients patient small Ewing the also up with small an data presented enrolled indications with Ewing data who types observed Salarius with Salarius next with encouraging poster is cancer up be demonstrated this to trial. session. be patients also subset XX with we This now with clinical to topotecan are in XX single therapy. the FET-rearranged of agent levels be myxoid enrolling recommended at actively or treated seclidemstat other X clinical and liposarcoma along cyclophosphamide from and patients ASCO seclidemstat of to drug the FET-rearranged tumor patients dose. When and In to during advanced sarcoma Ewing summarized, refractory relapsed dose from despite data being activity subset All single treated Phase in treated

discussed, expect We We and other announcing necessary also combination underserved the with readouts in clinical XXXX. seclidemstat in ahead previously and cancers believe much and forward in cancers, including areas additional of substantial hematologic look such use seclidemstat in as of future. near we efficacy completed trials unexplored to we trials is potential such additional that work safety the inhibitors. checkpoint in data begin as has gynecological cancer cancers to there for Salarius have indications the

to what take looking As future would today, for I exciting like times these forward earlier I now said to and questions. Salarius we holds. are are the

Vice Daniela for Joining Q&A Dr. this CFO, questions. portion the call of Mirza, the Development call open Mark and I Development. now to With of Senior Rosenblum, will Dr. is of President your Director Nadeem Clinical me Santiesteban, Corporate that,

Operator

[Operator Instructions].

Your Benchmark. from first line question Aydin Huseynov comes the from of

is Your now open. line

your You may question. ask

Aydin Huseynov

questions. question Hi. for my on I taking ASCO. first is Good afternoon. a Thank have you

presentations? now. efficacy abstracts from press about see initial the the one efficacy So expect says, relapsed release we to sarcoma week I are to preliminary just from Ewing in to ASCO tumor going what wanted from and I solid ask, from trial. signals think

So see a actual Or are going be study? going overall this to more case response we to is the like numbers?

David Arthur

the Hope hear you. you David. Wangzhi, well. question. to is this doing Good from for are Thanks

posters for. is, other based escalation to posters with have will the an expect both on released, are when see trial swimmer it's the criteria think we have plots solid of that also have and looking of identifying adverse safety data It treatment findings. you update that any I activity submitted we Ewing think short summary What most dosage. would of recorded length the common to information drug are So to and ASCO. will of will with It two and adjustments abstract, escalation you on a is trials you RECIST as that It also response relevant. and tumor have events. the know, share the three trial you the will dose the advanced for along presentations sarcoma And dose contain all I assessments

is as the believe you are able Aydin. the poster in looking on that my confused. data to becomes for apologize, my available. you to be going it And names got that access will I and I be sessions I that So

ASCO. So here coming are Aydin. from good for think is the up you. anyway, the for question at it hear you and looking It's information shortly I Thanks to

Aydin Huseynov

you. Thank Yes. Sure. Okay.

potential Another I question in hematological have seclidemstat malignancies. of is about

does CMML Oryzon's of responses inhibitor, iadademstat, us about based LSDX responses in MDS it AML. their XX% the LDSX you this given ORR potential be as complete in of you of clinical that success after the advantage another course, So to given appear well, be Oryzon seclidemstat But hematologic Of make seclidemstat and that What would AML competitive these pursuing. to the know, probably on result tell XX% with showed in inhibitor, would in it trials? long-duration that are pursue going Imago study and And to this AML? malignancy? both sense seclidemstat are as indications what for

Aydin Huseynov

those great clinic answer have and short the to we question. have we and believe it a Daniela. results real in we hematological and And plans answer is, enter short give to some going space. then turn over potential of pursuing seclidemstat So am hematologic yes, cancer cancers in the seen to Aydin, The has I

David Arthur

ask about to What Daniela little is Dr. do bit I on and the going like science more Santiesteban, would believe to a why Daniela, be successful. to little we comment detail and we are

Daniela Santiesteban

Yes. for the Thank you question, Aydin.

So excited we very are hem the enter space. to

Oryzon. by for well validated we it's inhibitors, As instance LSDX have been said, that others

As from being you differentiated the a LSDX protein. location of know, clinical inhibitor reversible and it in a the that is LSDX inhibitors within other seclidemstat interacts different it's currently trials,

that think when azacitidine advantage overlapping toxicity, of LSDX in we in have both inhibitors of to toxicities. other hem profile hematological an contribute terms into where will combination having safety run So factors with you us those often given

that We And more safety course, revealing clinical have yet. the our seclidemstat not in be with data, seen during trial to-date conference. ASCO of we will

So think attractive give the with disruption because LSDX is the transcriptional very with associating to repressors. disrupt indications for LSDX we an seen reason to inclination of have that that able effect are advantage. we these we ability certain mechanistically, why And And us will that from seclidemstat. is have inhibitor's

is and toxicity hematological has of efficacy is having also the advantage terms not rationale there. So the significant in seclidemstat for there

are those excited reasons the are So to we that enter space.

Aydin Huseynov

much. very answers. potential seclidemstat's appreciate CNS. the last question in I I Okay. Thank you opportunity regarding your And have

vafidemstat, published in you probably inhibitor, personality of as CNS Oryzon disorder that indication. first-in-human data So know their LSDX

if specific plan CNS seclidemstat seclidemstat? potential for a think CNS? you any in has syndication do yes, So And out-license you would EPS

David Arthur

Aydin, a great question. that's

We system this exploration CNS the extensive in not point, currently, pursued to area. or have nervous central

perspective. my go have first? from do information would Daniela you additional any you give can perspective? Daniela, I or to any think don't you like I Nadeem, So

Daniela Santiesteban

Sure. Yes.

of more others. cases tumors CNS you very as for the But bit we some a good and don't and inhibition doesn't that it blood-brain in a than Seclidemstat where might different there is space, barrier of has validation barrier little get know, interesting area effectively the it's Aydin. every effective even crossing been penetration. with somewhat disruptive, molecule as blood-brain LSDX So cross be

So will space. be that we outside the in can a indications indications. means thing of some other that likely CNS target good it But

Aydin Huseynov

much Understood. for Thank very you answers. your

Operator

you. Thank

comes line Ladenburg. Li Your question from from next of Wangzhi the

now open. line is Your

You may ask question. your

Wangzhi Li

Hi. question. Thanks my for taking

do ASCO. at week, follow-up a to see, would next will new on expect week? abstract we data a present next or see just to Or the quite Just versus the be the actual presentation to similar? want be significant Since abstract difference they out

David Arthur

David. for and include posters information criteria only include of They mentioned Wangzhi, think doing this findings, Hope assessments I that are summary activity not drug detail we contain include that that Thanks have is on the and support assessment the or The extensive the but The I that we we are really the have referring believe clinic. RECIST The about in significant they on studies. drug you is comments see on two only have continued the ASCO and previously, maybe are really we development submitted detailed plots you criteria. that posters well. feel in questions. you to, drug, the short other abstracts poster that two swimmers this and the as and safety also the demonstrate we the provides for the know, information findings. of abstract, supporting response submitted

sessions. for information to the I you going really is think in the looking So out are poster come

Wangzhi Li

maybe information interpret benchmark? you color that the we If now? view helpful. on historic And of you the will could benchmark to are some not, especially That's seeing poster includes on provide under the some context efficacy or the for context then is, results the should question it. or Got how the

David Arthur

and have and from to the do little a Wangzhi Nadeem this few of of presenting their reference in it some going or provided chosen some am So we to believe that to the for bit Daniela we of then other have And I of ask present, a companies comment. I we historical in data a what format accepted memory cases benchmarks. the data. in use way as put some

I posters. go letting pull the to references numbers. you in get up what looking think it But a read we our I at of I I to provided Nadeem need may have see have am him and both couple and got the So poster if correct. And believe then you comparative will

Nadeem Mirza

Yes.

are David, correct. So you

have based presenting. data mentioned, for been have the references after to reference we as of the is poster. how or absolutely, data evaluate the comparator. with Unfortunately, presented, are can a of through you happy this have on comparator. the happy David conversation So others at But provided the you shared And in you a we you which and some that so the And in we walk presenting comparator certainly, trial are look some discussion. have cannot you noncompetitive in the we to the data put data have can

Wangzhi Li

Got great. it. That's

think were you questions. very Thank my I much. those

Operator

Thank you.

from Research. comes question Equity next of Diamond line from Your Diamond the Hunter

is line open. now Your

You may ask your question.

Hunter Diamond

Hi everyone. Congratulations on progress. the continued

managing may know you So you But team, company. of you more think advancements angle Mark. color watching the $X.X be this may to had guess, lot take advancing I guidance. about of not a the burn the million. time pay expanding are for I And I recently budget? either also saw the we around different balance? the questions to was headcount. of at giving the trials formal a expand and I wanted versus go scientific the looking more cash I but are just I just just see spending, a on thinking lot the around recent just also And on any a same how, different to how be salaries wanted

Mark Rosenblum

spend the did additional capital cash in charged be to hit The accounting, not just the million, cash Hunter. in see additional paid not which, in probably, capital used of on Yes. about raise we give you number you operating to activities related an and additional remember to probably, would $X.X P&L. we Thanks degree

in activity. We as the thing. advanced So which That's financing opposed it would operating is to receive accounting, sheet. from go to did CPRIT also one balance activity, $XXX,XXX the

be related back probably professional you would the information you So in and that seen guidance our put number $XXX,XXX to mentioned have the to would have the capital publicly. in and month. $X.X to million And million have in amount $X provided the number related line which spend would we is you a per raise, have fees, if past, we we about with added

headcount to fees. normal. very replace personnel section our it additions, And will or the It's in the As business. R&D consulting of also,

So as outside a company, we number younger used scientific activities. a and for consultants administrative of

we in-house As bringing where can we get a we grow, to those opposed dedication XXX% activities are consultant's of people's as time time.

So we numbers be are the to swapping going really little out a just bit.

dramatically really had we forecast would overall has number. same stick and Our with not what changed from we probably those

So from time to we time. this will update

a growing are company. We

On down first they the basically side, I end fees lower in the related the professional quarter of XXXX, to, transformation the were we than public mentioned, really XXXX of a at admin first being on to quarter company. the as and based were again,

in in will, comfortably but are don't We headcount, direction. on administrative commented we anything personnel or and you if a haven't staffed. that spike We see general

Our efforts are I on question. answered the your scientific side the that house. hope of

Hunter Diamond

No. color. the Absolutely, And additional I Mark. appreciate

question if am available. almost about appears I balance, to I small-cap sure has buyback not So its cash companies a The right. have in have near my be this. seen other last thought company trading and And anyone

million equity the if a reasonable reduce financing. have of dip use say, good we cash company below has radar? shares the own has have a now So outstanding few are undervalued, the seen shares. our microcaps okay, company something on and other I to the going it's and Is of amount thought to purchase our has a it's the level where allocate about come or that To it a

Mark Rosenblum

good decision. Frankly, best we think comment. company. you the place of R&D right, cost a is marketplace put choppy the Board comment. our if our not good always to is early it It's And our into This it's is capital It's science Mark bet of the best We on and place a a our stage have the again. it. will. to considered biotech Certainly, use can the for dollars waters, bet everyday

Hunter Diamond

Understood.

biotech a I because and as Perfect. on I seen know, that something you out day-to-day volatile Okay. would figured just It do was companies I other have be very just because, movement. weekly bring can

So Thank my for questions. okay, congratulations you again, And the progress. with perfect. taking

Mark Rosenblum

Hunter. you Thank Yes.

Operator

questions David you. no at time. I the conference turn Arthur. Thank showing like further Mr. to Sir? would am back this I now to

David Arthur

Thank you.

Salarius entered combination with had never We actively chemotherapy and all stronger you as multiple and populations and year firing seclidemstat treatment this a position. treatment enrolling agent. been a in positive a So as treatment patient discussion, today's for in cylinders we momentum common heard on with for from now are with single

additional We the to trials the upon beyond. the as cash and all. are first million today. would would and building extend safe. their our momentum thank I $XX.X fund sincerest and quarter ongoing you and time we planning to our you equivalents, continue forward announce to development I for thank in clinical Thank your in clinical expand trials and near advance future through we completion to cash loyalty clinical with closed stakeholders and look enough this and wishes and maintaining We our and and like to attention of Be time your dedication for my to for appreciate seclidemstat. good their continued and health thank support. employees always to like today

Operator

and all for Ladies you. call. Thank gentlemen, today's concludes Thank conference that participating. you

disconnect. You may now

Salarius Pharmaceuticals (SLRX) 12 May 212021 Q1 Earnings call transcript