Salarius Pharmaceuticals (SLRX) 11 Nov 202020 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2020 Salarius Pharmaceutical Earnings Webcast and Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is begin recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, to Mr. Adviser. Strategic Tiberend Rando, Jason Thank you. go sir. Please, ahead,

its available everyone, morning third quarter The afternoon, afternoon, September Pharmaceuticals release, XX, and months XX-Q release the salariuspharma.com. call. thank XXXX file also Salarius today's Salarius be detailing press a joining XXXX, for issued results financial listeners salariuspharma.com before open, in ended the found this for three you Earlier on tomorrow Good financial and and which results market encourage be we press the sec.gov. to will will a read. can News of and XX-Q section corporate

regarding about beginning Today, strategy, development of the to results information, the SEC investigational with on would the differ contained to of we’ll result statements. Pharmaceuticals including Before future expectations, section Risk future SEC whether future Salarius make like Actual drug information our with we any statement. based on forward-looking events seclidemstat, otherwise. detailed risks of results from time. new to may statements, including disclaims a making the our statements as statements update about filings reliance undue our and not Factors time materially due in filed or following obligation and These XX-Q I are our Salarius call, and be and our and uncertainties, other these Pharmaceuticals the should events to candidate, allocation in expectations, lead operations, forward-looking those statements statements to capital current study today's place plans, make including our related you and circumstances, resources. cash expectations these

ahead. Salarius' who’ll update go for will the financial Arthur, achievements third is CEO review who Director call David, third XXXX of Salarius' future, quarter on Salarius today's vision provide Pharmaceuticals, and and Mark results. and CFO, its the during on Rosenblum, quarter clinical and David an corporate and Joining

quarter our exciting be joining including to joining and and first to Salarius Thank of you for made, strategy the other third for solid you, treatment opportunity and the you as conference potential pediatric for an illustrate during progress our Salarius all afternoon, and year that cancers, call continues affirming Jason, seclidemstat highlighting a everyone thank events cancers. tumors growth significant offers this the XXXX has time.

participating adults to them of clinical a need describe moment first nutshell, and those stage with medicines For are new for me developing a you treatments is Salarius cancer, developing for take most. Salarius. pediatric cancers. solid a and potential let In biopharmaceutical children the patients we tumors for time, who the company, other

trials investigational as are types of seclidemstat treating explore We a in cancers. drug potential our two currently patients treatment for clinical to oral with multiple new its

cancer, XX%. survival most of soft with only is year sarcoma prognosis patients rates metastatic sarcoma, pediatric Our spread lead already clinical Ewing program which time that rare bone common diagnosis, has sarcoma, and survival devastating children a year Ewing among adolescence. or have at is in tissue the tumor second the and is between five Patients diagnosed XX years is diagnosis particularly of a approximately for age. after and with The of XX patients of recurrent with of five the only poor. And median Ewing XX% The Ewing recurrence XX%. unfortunately, is age to Ewing cancer

grow what provide about in bookends an third pediatric select Seclidemstat cytotoxic to a a welcome There has important plus backdrop, represents Salarius. breakthrough for quarter. trial Nadeem meaning July, announced and solid we Ewing with human several include a our the plans to let's expand as to events higher, sarcomas now we he pipeline. patients Dr. In talk months active that instrumental our advancing has clinical As our well of agent, Ewing treatment ongoing cancers. to oral With Mirza July, similar three opportunities identifying as to the been as sarcoma. biology is In were clinical Dr. in regard, in that this Since that seclidemstat potential that Clinical Development. tumors, breakthrough, been share seclidemstat not not a a sarcoma as our Vice Senior twice-daily Mirza, programs President is potential a potential of is treatment, chemotherapy. in

this sarcoma target lesions reduction agent and a this believe measurable no part As disease, represent was we treatment We therapy, remarkable treated challenges any highlighted of single fact a other generally demonstrated treated this a their a patient’s that months, patient over that with with seclidemstat. defined is received seclidemstat cancer meaning given was while announcement, the seclidemstat XX% of and result, lesions. Ewing refractory Target patient of six for the and tumors. largest taking the who extreme prospectively patient

not provide public While advances treatment patient with to this Ewing opportunity patient, million to in efficacy. from recognize momentum single a drug $X.X initiate only complete a we resistant that in believe demonstrates Salarius safety, activity and is a we offering. a these trial The designed in primarily then an demonstrate August, sarcoma,

later. bit Mark, Rosenblum Salarius’s to resources third of to as a at the are the Institute for progressing turn Texas Research more time, continue financial program. ongoing go the a for like these now like please of Mark to seclidemstat I'd our capital But review this we the brief development clinical well Prevention ahead. now over the and resources Cancer trials quarter We applying as discuss development call program, in from to I'd detail receive report.

David. you, Thank

manufacturing period. expenditures the research related The administrative into of transformation the expenses. time Increased increase Salarius’s decrease $X.X $X.XX costs. and of and loss company resulted in before was the basic loss For decreased other resulted to and one expenses, costs seclidemstat million a did months clinical period, loss from which research Ewing the income the sarcomas. current reoccur not than administrative three increased period fund during a net development development in compared or to for in the due compared period of and general early of from public overall to costs in last absence share, Salarius and operations September year, $X.X XXXX to million offering August expenses this million $X.X and stock. decrease basic million trial The include XXXX, year to which XXXX. offering in ended In XX, more a from same ended to million, completed public months for other by the net clinical same intend primarily $X.XX a common the for loss share September a which per use Ewing our the $X.X the general, offset three Salarius expansion trials ongoing of diluted the the sarcoma underwritten to related $X XX, diluted million We or $X.X reported proceeds of per

however, As XXXX. at of cash, cash, not XXth This year, does and to year September compared the reflect resources this cash the restricted $X.X equivalents million $X.X extent end of financial cash total was with accurately million Salarius. available

help the of subject Institute the to On of interesting aspects clinical and non-dilutive genuinely from million non-dilutive received story Salarius Cancer have our National top Ewing trials. believe to that, funding Salarius which Pediatric One CPRIT meeting certain we the we grant ability fund sarcoma the $XX.X CPRIT, access is underappreciated $X.X we Research Prevention of we of and the requirements call capital. million Foundation have Texas, under which contract, from available to our approvals. and of XXXX, Cancer received an In

of to second With financial clinical half solid advance sources, programs we the I -- like funding the tumor advance believe these has David. Ewing into various call that, to would our XXXX. the Salarius to resources sarcoma return and With

you, Thank Mark.

As creating value. seclidemstat and families and hope to building shareholder all our is by we facing maximize while the potential treatment their goal limited options, the discussed, to of bringing patients

solid opportunities forward in XXXX advance could other seclidemstat tumors, current and end into of not cancers. XXXX the Looking we sarcoma to expect Ewing but also explore address beyond, programs through where our underserved clinical and only and

are the look work seclidemstat. As sarcomas Ewing and These about with similar sarcomas is share gene investigators round the completed are now trials on recommended forward to patients additional sarcomas as highlighted related Also, necessary We sarcoma allows are Ewing doses plans cells. are announced sarcomas. and of specifically to additional treat in several XX immuno-oncology known us quarter, liposarcoma, new designed potential trials, to a interest related clinical our who of clinical myxoid that similar seeking Checkpoint sarcomas the to Ewing share we we patients options. treatment near to include also during cell in to a expand tumors of begin trial phase rearrangement earlier to the Salarius in inhibitors. of sarcomas with and interest One in additional we these immune seclidemstat to to Ewing treatment expansion that much a cancer excited call, additional third These small Ewing sarcoma. combination enrollment to Ewing related had Ewing these with the This of a Desmoplastic up discussed announcing the include biology II use future. attack sarcoma. system in checkpoint treat and patient's other inhibitors previously immunotherapy class the unleash July area therapy, clinical

these these or types. patients do cancer drugs, all in all However, in inhibitors checkpoint cancer work not

system a terms, the into and checkpoint Research a seclidemstat studies tumors known disease Phoenix, attacking checkpoint Interestingly, patient's resistant approach demonstrated it be PLOS opportunity ability could potential the that inhibitor patients tumors with these called relapse. identify checkpoint in treatment a by the then treat to system the prevents wide or the journal, tumors cancer. for conducted from addition, seclidemstat, are overcome is currently significant respond to inhibitors. of now preclinical treatment of immune data able inhibitors of to to inhibitors return show that In the patient's Arizona, immune become cancers could from and with provides hot tumors can response of concealed because hide turn in to inhibitors. using Institute may from system. initial cold to Translational This In seclidemstat unresponsive a used patients the combination and in cancers published immune hot tumors infiltrate, an a simple to peer-reviewed commonly Genomics checkpoint from ONE variety do experience This disease, as checkpoint

next dose-finding characterize Both MTD. designed of profile in mentioned, it tolerated seclidemstat trials open-label remain solid As to us for year patients maximum Ewing-related Phase and Ewing our quarter trials most pharmacokinetics MTD dose, clinical is in to with of sarcomas. is of will programs. the Salarius objectives up treat patients the will with establish Ewing-related previously or and on dose-expansion arms are XX establish the as begin milestone safety the X as primary the allow these the we the establish in expansion and dosing sarcoma sarcoma is to now Reaching advanced where trials, MTD of track the and to important trials which drugs regimen and dose-expansion treating portion the an Phase Ewing development tumors both and trial. X to first Ewing

the patient support patient been in was efficacy observations have are animal drug far, models. and This are, size clinical treated which expand of their data when dosing, twice to these as of and standard-of-care concentration to where and So as the the X Ewing to XX% drug achieve noted who two clinical observed efficacy with and encouraging. oral results data with confirms achievement measurable with animal seclidemstat at our patients an from in preclinical we preliminary this dose-expansion observed clinical for other the trial target Ewing as clinical ability we data prospectively include above phase mentioned, humans and with trials programs in demonstrate Data noted cell tumors. our in have patients, levels Phase failing with is generally in drug studies. both decrease a regimen Ewing-related supports sarcoma patients Also, early coupled months twice our six levels we humans in identified clinical preclinical observations that and or or lesions, decision treat where believe sarcoma dosing activity, saw the largest patient's after the I significant daily daily a our earlier, in it therapy We regimen, can sarcomas.

fronts larger likelihood potential In is position or helping an that In and progress over in identify have the the on the turn may the and I cancers, ovarian were your also cancers is since clinical beginning Salarius the call made past the activity. have accomplishments ongoing solid questions. while breast, market three quarters. the of to in opportunity all, investigate tumor year, substantial. as With addition, we These such specifically treating increased trial growth seclidemstat certainly show tumors prostate, to now next for seclidemstat several that, providing months the over of open will several

show comes Benchmark. [Operator Please Huseynov I line Aydin Thank go from from you, sir. Instructions] our ahead. question the first of

combinational Hi, cancer. that’s for my Thank questions. gynecological Could thank therapy I can recently things called combination omalizumab with trials. taking of you. trial regarding on comment start I that? you one saw question clinical you for that had then

trials Aydin, good I from the question. study of clinicaltrials.gov. to publicly at has unfortunately, Salarius cannot this for hear not that Thanks listed aware I comment you. on moment, on am that announced. But

further press I and in that But releases not our So to going apologize. we to near monitor as announce I the our encourage question. But answer future. communications I'm to to public have information would you hope

And indications will that. you. trials, and reasons why of whether and them pursue pursue for haematological release kind Thank might to any preclinical for you comment thank you the could you planning you're what data? you the Sure,

to be do to the happy what also Santiesteban Daniela, I'd line? I'd is and you Dr. on like are with Salarius. introduce Daniela

Yes, question. David. I'm answer and Aydin’s Hi, can here

you. Thank do. Please

like to and in have pursuing, good myeloproliferative a were clinical MDS. trial. key we'd to haven't we announced in preclinical Hey, to a In to data we But talk indications regards you what of Aydin, AML specifically in interested pursue again. variety diseases including shown indications that

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solid so how had is you. Phase could updates question last enrollment Thank X, Phase you Thanks any tumors is Daniela. the regarding X -- much, And the going? I provide of enrollment the

to Happy to patients. enroll solid Aydin. The tumor is study continuing

lives, these by open trial failed of we've large things as fact We treatments. and that have sites. is solid one fact to both at Due studies a the our -- business the aspects of all clinical both enrolling highly are who prioritized trials, our that investigators have all part of has sarcoma advanced about while clinical they our our are COVID standard-of-care patients in are the remained been Ewing and pleased tumors affected personal very existing

feel have to I in enroll communications, fortunate to in reported and continue tumor been in maximum solid we are escalate patients And the to are near the fortunate, to in we so continuing to hope study, that incredibly our we're dose. the future. we've study dose in many we So, an the as continuing advanced achieve very able enroll advanced solid tumor of the tolerated

for the All right. Thanks Like question.

you. Thank

line ahead. of Our Diamond next the from Please question Hunter go comes Research. from Diamond Equity

Hi, everyone. Congratulations on the quarter.

So, I questions. quick two just have

in talked trial the about in into timeline the then the those and the the the have logic was events? obviously related it looking move Are qX sort know deck and to trials. could those of Or latest human immunotherapy XXXX. on to QX still one QX the of So, we trials. Ewing, I some they

we're our make Salarius not have HonorHealth going in immuno-oncology discussed So, work will is clinical just are Good I be as comment Aydin tremendous yet as cancer the one, believe, the the Hunter, In the if we on for the placed to disclosed we to in targeting to additional believe hematologic I'm And of you. you near in third The all, from clinicaltrials.gov And from work thanks completed that on completed not happen. hear this study initiate I I quarter, mentioned previous outcomes involves studies. share we've occur a I TGen to future. to of corporate a and brought necessary available as I earnings as up, and that with able the And actually -- it. and on said, seclidemstat, necessary trials. position discussion. question. to that a much, amount our information deck, the in and

can forward excited know quickly we're you you on to think very And clinic that these we're the new I very, these all get fronts. indications. can moving into So, in pretty

we and the you very near in additional tuned future. out hope get stay to So, to some information

as is funding you on and of that the has Okay, assets that. well Or something or a giving area. trials? be you sort could maybe a epigenetics, aware been radar? that super-hot is are My you a perfect. on acquire company's more about? at the is Appreciate to focused Is additional update second you're of asset universities obviously sort think some I other are potentially could there is capital non-dilutive thought question opportunities the Or there existing may was that's acquire. And would raise on good that if the that

The great are -- good program. seclidemstat about feel we -- -- our I question. think a we you're asking very currently And we

are sarcoma. advancing Ewing include we have that sarcoma. about to -- be near We've studies and Both to in and We clinical in asked future. Ewing announce very solid the related you in to hope additional expanded able tumors. advancing We're Aydin we formalize the

with of any new and this, the with So, candidates mean, with drug clinical that company, we say I an IND-enabling we about investigational not into interest drugs seclidemstat. how I to and applications sure implementing not getting is advancing to through make the Having want studies, biotechnology could FDA -- clinical make trials. possible infrastructure said taken I'd comments forward negatively. and that as capable submitting development business I a clinic always are be because moving happier

create them them send please good and them don't if if is bring and shareholder into to -- value and something come to hesitate and you we're our ability considering, candidates way. additional you across Salarius drugs Our additional always identify advance

And Sure, do absolutely. will I that.

That's perfect. I the terms have on all quarter. questions. of congratulations Okay, in And

you. Thank

this Thank Wangzhi Instructions] queue. time. in David closing remarks. you. Director for -- ahead. line queue your no Ladenburg. CEO show sorry, we from Mr. actually I questions Please the Li the to the the show At go open. time, this Wangzhi, Arthur, question is turn show no in I from and I'm to over at have [Operator a questions further like further of call line I

Thank you.

And -- and you. today, discussed work we we're to hard we've And footing operationally, believe we appreciate families with appreciate I extremely their very is momentum. all time I on battling is feel Salarius on hope financially. of working believe Salarius As treatment I devastating in strong care Salarius for maintain patients to our you developmentally be I'd and momentum are my these loyalty. extend who that to dedication wishes always, are our thank as their Thank to the bring to safe. continued we have. and And attention. to called employees currently want well about for to like cancers health as new all. our I'd like I for seclidemstat. today. of I suited their Take good sincerest support, and And and to your stakeholders good and thank

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

You disconnect. may now