ONCT - Earnings call transcript Q2 2019 | Oncternal Therapeutics, Inc.

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Operator

Greetings. And welcome to Oncternal Therapeutics Q2 Earnings Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder this conference is being recorded.

to Chief conference Financial like host to now Vincent, Richard Officer. would turn over the your I Please go ahead.

Richard Vincent

discuss financial Thank you, of to to you like our to second operator. Good development afternoon, our everyone. clinical and conference programs. an and provide results I'd preclinical welcome Oncternal update quarter call

tomorrow. June release and Earlier file for XX-Q out earnings results XX with business Securities reporting ended the XXXX today, Commission we issued updates and Exchange Form the financial our and to quarter plan

filings of of available website least Our replay on the at at be a call will days. and this for XX Investor our the section next www.oncternal.com

me today Breitmeyer. With James Oncternal’s is CEO, Dr. and President

call for and a ended will our of provide XXXX. Jim an the overview June summary XX progress. an our pipeline our of second I During brief business quarter financials will update today provide and on recent

brief a with conclude will Q&A. We

obligation statements revise X, date events date of circumstances to sensitive Oncternal after Reform business and and Harbor cautionary the statements June that its call will this Oncternal’s or of statements should time business. the certain update and is that in forward-looking Form the Private undertakes the live by Please covered ended this is the Oncternal’s the note be statements be forward-looking on call. Litigation under considered I stated and information contained broadcast, conference today for only that the This Oncternal These provisions forward-looking looking about implied management performance, reflect XX to materially of this from quarter of the call call by strategy in could with events future those or conjunction or operating financial these due release statements conference actual any uncertainties as Act. future qualified information filings, caution associated Safe XX-Q results making discussed and with contains earnings August XXXX. Securities SEC risks and to during including no are listeners accurate differ forward Company's

I'll call that, turn the to over now Jim. With

James Breitmeyer

you call Good the Oncternal conference first Thank ONCT. Therapeutics we afternoon, trading everyone. NASDAQ for commenced our as Inc. Under ticker on joining symbol since

were trading efficiency the We are with NASDAQ will we market of on speed to reverse merger Rich debut the through and which described the in able a proud that call. later

But to make our product we're was we momentum continued pipeline while focus merger completed. reverse particularly development even by of the proud clinical on being have progress and development, maintaining the across

some What we patients to for like that been at why I'd provide pipeline our we've excited the cancer. about with on. insights candidates Oncternal what into are the have accomplished and so may impact working we've in drug potential

of which start attack development with an to grow, use product Each of thrive to or our clinical specific very one two of our consists me overview program. designed and preclinical candidates product Let that is candidates mechanisms stage pipeline, cells metastasize. cancer

continued collaboration best on highly on We discoveries institutions, important therapies have development potential development With expertise minimizing healthy focused with team the drug are new cancer academic novel patients. cells. our a and turning while pathways, on and for approaches developing targeting identifying effects into focused for these drug we experienced research

and a currently chronic antibody which RORX, a CLL lymphocytic Phase cell receptor program for monoclonal in mantle cirmtuzumab, in trial said R-O-RX with designed MCL patients ibrutinib combination with leukemia lead inhibit lymphoma clinical Our or with or to is is X/X the a patients

treatment standard cirmtuzumab with that a genesis, implicated need. and the treatment with of with MCO. cirmtuzumab is clinical is of serious cancer in important In disease the for important in believe of trial becoming RORXis and an resistance. We a modern unresectable the treatment or X paclitaxel and breast addition, cancer. unmet Ibrutinib metastatic ibrutinib Phase patients CLL medical believe care a address progression combination We target patients in and of tumor may in combination that of

provide toxicity encouraging added or responses complete ibrutinib of without CRs therefore clinical in And have meaningful trial that treated we in clinical ibrutinib with our is substantial increase patients is the achieving CLL to patients patients early agent in benefit. uncommon cirmtuzumab already a needed and synergistically and However, would number development, seen while responses believe in with MCO. works are with that alone. an CR We

in trial June treated we the rate clinical the combination a annual in treatment portion patients that consistent and XX X In This ibrutinib response three for ongoing interim XX data of demonstrating meeting, or X cirmtuzumab Phase an the CLL for of ASCO of cirmtuzumab or study interim the clinical well our Phase first with with at included confirmed objective ibrutinib patients of presented from profile, part X/X responses overall safety with - who with tolerated alone. had for complete scene weeks treated more. XX.X% received

open XX scene valuable week, to cirmtuzumab data patients CLL We part completed enrollment confirming part response dose of that ibrutinib who recommended cohorts, the Phase the have and that of ibrutinib regimen this observed nine see from of by of with for in tolerated X/ announce of trial profile triggered trial this outcomes a for favorable objective alone. part X plus part patients clinical with XXX% the pleased finding we ibrutinib dose ongoing to were treatment the we including Earlier X receiving rate CLL continued first weeks consistent with an interim and in randomized the cirmtuzumab, well in safety dosing have treatment have X with

relapsed from were ASCO, who of that at treated patient cohort mantle lymphoma separate had presented a allogeneic six an One Phase transplant patients X/X with MCL following study. results cell who the preliminary X complete months in were with it large plus of complete including treatment, cell results stem be in appears This after Included response a mass. ibrutinib confirmed resolution X, of treatment. and XX X complete has confirmed to a of cirmtuzumab durable, ibrutinib after plus mediastinal cirmtuzumab response months experienced and been

an That and open studied being X San Phase combination enrolling in metastatic the with patients trial also investigator at paclitaxel is California, initiated with patients in for study Diego. clinical breast University is of unresectable or Cirmtuzumab cancer.

was by the has at developed pioneering on or School Dr. from Kipps colleagues of and grants supported Medicine for Thomas of been Diego scientific research San UC Medicine, the the his Cirmtuzumab Regenerative and CIRM. Institute based California

of X provide CLL plus We expect this our brute breast the from later the enrolled additional of ibrutinib enrolled additional of patients a cirmtuzumab including study plus portion in paclitaxel. Phase and of to patients cancer with updates in clinical results studies both cirmtuzumab, from Phase for study with and year, cirmtuzumab, MCO X

first a clinical the to enter transcription Our the biological of is types. investigational to small ETS oncoproteins TKXXX, in the designed of molecule that clinic factor tumor variety ETS-family program activity or is other inhibit

Ewing lead Virtually first sarcoma, Ewing of indication all TKXXX by cases oncogenic but line protein for express few a targeted ETS devastating rare options TKXXX. after Our cancer potentially that fusion chemotherapy. pediatric an is bone treatment sarcoma with is

fast received eligible has status program drug that and designation believes FDA the pediatric and an Oncternal from track already voucher. be for orphan the a will

and to treated that are expansion with enrolling recommended sarcoma with expect study sarcoma. a of combination dose vincristine XXXX. portion cohort Ewing of complete patients Phase in of TKXXX quarter study or the X TKXXX in patients select almost relapsed with We an regimen alone a dosing third we The is Ewing in refractory in and Phase finding X evaluating and begin

to been to have that an are immune program from third is effort CAR-T a Our cells preclinical collaboration T CIRM. grant with been system cancer engineered anti-RORX therapies research San on and own bind is in UC also which specific the against therapy CAR-T to cancer react has direct target patient's cells funding development those in This in an by engage cells. Diego. supported

RORX target its for common and a due therapy solid an cancers wide is tumors. believe variety attractive We CAR-T blood a across of expression to

bind to most Our not targeting but human with high-affinity, to normal antibodies recognize cancerous cells were tissues. designed

goal is select CAR-T candidate year. Our clinical with candidate the lead next and therapeutic our trials initiate to

update number biology concludes traits diversified cancer own leading potential demonstrating of this programs. saying oncology on with serial pipeline and companies, proven developers untapped drug in Oncternal clinical key drug comments to candidates pipeline has success, emerging of found I'd therapeutic our entrepreneurs my close like its data and formal a activity. DNA, biotech targeting That in business biotechnology by a

the in our of unwavering has we made to new proud commitment progress are Oncternal and We building treatments remain and pipeline to advancing cancer oncology bring its patients.

I financial Vincent, second will now Richard CFO back to of turn call review the results. to Oncternal quarter

Richard Vincent

wholly-owned a the the private merger surviving GTX completed Thank Oncternal you, as agreement merger subsidiary. and company. Xth transaction with its subsidiary with with merged wholly Under the Inc. held XXXX reverse Therapeutics merger a privately June subsidiary merger into Oncternal of Jim. owned Oncternal private On and

in method reverse accounting Inc. purposes. GTX to Accepted for The corporate The with accordance financial changed surviving was a be Therapeutics for from inquirer of Oncternal acquisition transaction as to accounted its Principles. Accounting name reporting entity Under deemed the this accounting Oncternal was Inc. Generally private asset

effective periods those the be As for prior date of operating as closing to of result, the Oncternal. reported of closing historical results merger the the a will date merger private

prior hand, on not the Oncternal to reverse months the All for occurred per closing the hand given which comparisons ratio reflect presented within GTX be seven growth Furthermore the shareholders share shareholders for merger. both or has and Oncternal XX share stock meaningful. exchange figures period period split experienced all other for private one over period last for the may immediately of on the one of the

results, information For be the quarterly and filed report to merger review XX-Q which June the on financial regarding XXXX I will transaction Form XX, reverse our for our you quarter ended more detailed invite tomorrow.

quarter $X.X was million revenue Grant XXXX. June ended for XX, the

the patients lead Our in grant B-cell is and was CLL trial program grant The with X/X grant to MCL with San from of with awarded lymphoid clinical CIRM malignancies, Phase advance evaluating a of cirmtuzumab University combination in including our Diego. ibrutinib the derived treatment California, for a revenue clinical subaward

was for the $XX.X for in-process of acquired one $XX.X merger. which the connection with charge and were closing non-cash in of million, the expenses that operating included development research Total million expenses quarter recorded time

and per expenses one-time for $X.X diluted. second of was merger charge, the basic Including quarter the share, Research million, and $X.XX or million. the and totaled million. development for quarter for quarter the totaled General net expenses the $X.X a loss administrative loss $XX.X

to second We will June fund sufficient million had As in these cash of believe its equivalents. into of funds be operations quarter XXXX. XXXX, and the we XX, cash $XX.X

had XXXX, As of XX, stock shares million of common June XX.X we outstanding.

discussion. let's call Operator? the financial for open the concludes questions. that, That With

Operator

is [Operator Instructions] today sir. from Our you, Please Hartaj question Thank of Oppenheimer. Singh first ahead. go

Hartaj Singh

Congratulations your I the little you have for call first don't guys bit. questions. here you voice excuse me. mind, if a just a on My and thank Great. few

XX the X then Phase Phase with your X starting So of patients. congratulations X of Part and on finishing the X/X up you the in the part first Part are study

about the randomize complete a Can comes bit out wait just or about looks about report XX like just response. couple are with of set CLL I for what set how And be follow primary talk you XX the up per ibrutinib But sort patients cirmtuzumab. I it you talk little know data? what are guess and questions. up are and up receiving just data will thinking you you. reporting you you got endpoint kind cohorts you the bit you a you how of - the just as till will get little know, will you know, of you to a Can the then patient then person way cohorts Thank - kind ibrutinib the of will it the

James Breitmeyer

for Thank you question your Hartaj.

that clarify, randomized me asking let is portion of way the composed.\ about study the the So you're

Hartaj Singh

Correct.

this start for? and then of you cohorts secondary Phase how one those and structured As what of the looks are endpoints structure you just the looking are X and primary sort then just like

James Breitmeyer

Thank you. Thanks for the clarification.

of randomized our will alone study with portion ibrutinib the be to to they and all will - with be X ibrutinib arm of composed and will XX hand. receive the Phase be Phase the CLL of one our X plus X and that the all either other X/X some randomized - on patients So portion cirmtuzumab,

- the X, XXX selected milligram the cirmtuzumab once that it's a the and beginning. of a a dose dose, doses at at study was the of begin is loading couple - the Parts X portion given So month Phase after the during X and

Now realize so that's randomized the – you'll portion. also

to that the also permit from the And Part responding have continue the just realize You'll study are it had X encouraging study we to we've to that are results and study of the parts ongoing. year receive such X of treatment. that who X on after part earlier patients amended

the interim – study label The portion one but is study. the is specified of only randomized - there open analysis and are during there

Hartaj Singh

Great. Thank lot. that you. That actually helps a

for another what's randomization [indiscernible] delta of just what's one versus the question that for your I the the arm is along two? looking the response, you your sort know, of Now you're bogey mono for to for have kind looking two the complete between

know, ibrutinib or response then patient just you public that know ibrutinib is is give you from with you in you previous I complete the that that just sort domain this And imagine to with experience you the in population? know of assumed tends I coming know the know,

James Breitmeyer

you Yes. Yes it most commonly be expected patients reported range X%. refractory response in generally for to for is. with question. in is less CLL disease the and XX%, Thank that than have of relapsed fact, rate who to The to ibrutinib X% or

arms of a detect in study. complete to of XX% response two between about rate difference powered the the is study the So

Hartaj Singh

Great. Fantastic.

see to to relapse you'd where whereby the is be your - is Phase sooner get you some Phase of still the types know you it probably with of if you regulators to I know data guess the it's result know could which kind kind that bettering refractory patients a order of really have an you is response complete patients you seeing enough I in to if other patient market X or in do are get think compelling front you or now interesting an know accelerated approval. that XX% going or to know, of mean, design, XX might know sort to that or you you could – a market? of get lead you even you So X the you there or and

James Breitmeyer

good robust be question, of believe approval discussing accelerated a would very that outcomes strategy. do worth to regulators That's Hartaj. them we study And the sufficiently and from emerging taking an with the potential

Hartaj Singh

for you a questions. of –are for That Is sort on And how just are the up out of purchasing that trials? getting know, or then like you – know supply how One ibrutinib. had couple helps is getting these that Okay. you sort are just lot. I follow a ibrutinib the market open you're you the you

James Breitmeyer

that free being very with product to a are patients established that But this that product this for are Thank donation have we're a you. agreed we've grateful we review of Pharmacyclics very the upon the to we company agreement to recent and - Pharmacyclics fact, is the in to and data their ibrutinib The we for generous are Pharmacyclics. supply commitment and this of through and cost the now. disclosed provide - donation study week, the provided expand has supporting ibrutinib entire study

That means who we year a their to trial cirmtuzumab with providing randomized ibrutinib cost study responding to their of treatment. continue support and entire are patients and the the portion including free after well on of ibrutinib clinical the are

Hartaj Singh

will can And Great. be sort trial of - also that they support to fantastic. there can an sign might ibrutinib the you that is donation. if to agreement Oncternal option be the help know or That's with with with I have is a of sort dependent any go trial that were you that there they more to path? Pharmacyclics the than agreement an know, full on mean, has make down run to you they

James Breitmeyer

an the direction expand That suggesting. would in additional that require agreement to you're

Hartaj Singh

of - hits know, which design the of then is you and biology that help last to question know CAR-T to what understanding know you going And and the CAR-T off just program, your know, of CAR-T that it. you cirmtuzumab Got the much target> How is you in and my RORX kind target. with for

very go the know play off you or the types CART-T would coming in you know, a how are the different again, going CAR-T you for a them with kind secondly And of tumor just you cirmtuzumab other? you questions. then future, sort of against the see to And before one much thank

James Breitmeyer

Thank much programs. Hartaj. you appreciate good We interest our for very your questions in

So the categories. CAR-T two questions fall into

about the it we design to is CAR-T to an one The that RORX we field. be know that important thought project would is what helped us that a first just addition

RORX identify a to that hematologic aggressive cancer lung a One does And number ways. the from kinds address subpopulations of liver that cancer particularly I'll malignancies. different of of is cancer, expression couple in of to

forms invade is is the resistance but certain therapy. at has When to on been tendency UCSD, due a tumor this confirmed laboratories. research and Secondly, of largely Kipps cell such expressed and in other Dr. rate, increased pioneering of tumor that characteristics to RORX adverse cell, increased to as an has a potentially proliferation

So we're in one a RORX other cell. words, tumor bad expressing actor targeting a in

antibodies antibodies depth really And collaboration tissues. have knowledge one adult through also normal with RORX studied not themselves Kipps do the deep antibody, Dr. matters of case. a we're been targeting our and that RORX antibody We've this recognize around in and using had extensively the that most the very

other is have been the cross - been a way what to tissues I but that laboratory normal complicates have by other their ever And development other reached shown ever mean published that are have clinic, that has - that with in there none none that in antibodies testing, have as RORX candidates. react product been antibodies

us RORX So we key CAR-T that - those take system that the forward. are I we think to are have that knew develop the intending about to that the led features

antibody is a question and second one, Your an also and that good we're is, CAR-T. developing

careful of profile is that the a it So is antibody indicates a has tolerated. the particular to facts that has the that cirmtuzumab development of safety emerging well paying antibody very we're attention set map that

any there were treatment X few that antibody. adverse the I to attributed mean, events if specifically serious monotherapy with that study were that in Phase a cirmtuzumab

X effects those that with side - we're CLL patients were well Now the infusions the the seeing Phase of of are typical and study tolerated in

are events with Phase patients one attributed of alone. discontinuation have a that trial, is that ongoing And the receiving is safety we ibrutinib CLL been X/X or clinical with to the treatment characteristic who not have profile there been any adverse that are observing serious In cirmtuzumab.

particular of their the So the risk we added in toxicity. will without have utility along patients think physicians, with efficacy who added antibody substantial desire

effects a the know of may program sometimes associated CAR-T I'm side immune certain those different CAR-T be system to most that respect be with systems activated the are little attack that side and The a level you and cancer severe. in is sure can effects as

common targets lymphoma yet, clinical to but our of aggressive a we considering are and there. patients require willing targets known accept syndrome of RORXexpression is potential and where such their the that we non-Hodgkin's higher to they be clinical and be we So or considering side Richter ALL, haven't degree as to efficacy we're physicians get believe effects B-cell selected the may more

think halves I So questions. your of I both answered

me - me I check if did. let see you Let and back with

Hartaj Singh

fantastic. you the sense and probably have that makes that's it's neatly is just it CAR-T lot the a that assume kind autonomous because of some issues No, hamstrung previous then RORX. the with of some sidestep antibodies an CAR-T of That I with of

case but expressing RORX go you able cells gun, for after bigger using you're those patient's know to So cells? you're a the in own be to this

James Breitmeyer

That's Yes. right.

were experimental And CAR-T cross so for reacted example they preclinical that tissue some the lung studies. observed the the RORX Bluebird mice scientists they that an and with preclinical a using substantial antibody for did of in toxicities their work system utilizing system with some

Hartaj Singh

updates. and much. looking forward the Got more really it. appreciate to you questions James, Richard, thank very

James Breitmeyer

Thank you.

Operator

of next Raja is Kumar ahead. Our question Instructions] [Operator go Market. Capital Brookline from Please

Kumar Raja

questions. my Thanks for Hi. taking

regard you the drug? to concentration plasma you what share And correlation the therapic the are of with of response can the expressions so [ph] far. the in to terms with cell RORX what seeing So also

James Breitmeyer

the question, Thank you for Kumar.

are on RORX a has every receptor surface CLL don't cell this on concerned fact are cells, a because as that in in of expressed cells. harder have they circulating patient been And confirmed we test expressed in mantle patients study and CLL has is have patient their coding far cells. that to RORX occupancy that the tumor little the the assay confirm the we RORX antibody is as use that the So expression we administering tested

three is dose four concerned, patients blood doses as As been the a had in are small. and finding each agent the cohorts we between the have far in our fact pretty solid Phase to every levels at correlation tested we that of range outcomes tested partial had single doses we previously - tested. study, had and expected numbers We middle we X in in responses have a we the selected of the of had that we dose had that we of have and saw activity all that

Kumar Raja

Also use resistance you Obviously [indiscernible] be there down know, with some increasing know, seems be there seems of you you speculate patients are comes those. ibrutinib combination, mechanism? to be suggest blocking once My what what terms that of you are both in RORX. to treated can the question could potential to the

James Breitmeyer

we Well, great disease theoretical progressive current the The X/X it's a question. yet study. phase in seen haven't any -

sorry I'm are yet. that responding that to So resistance our not are patients disease. delighted not sorry of experiencing We're we progressive say study and can't course. We're

the CLL mechanisms. of cells And we resistance from And the develops you hypothesis since the two will down likely the it that and number biology the but longer. you take be combination So does ibrutinib be down preclinical that malignancy cirmtuzumab independent and the be ibrutinib one remember a to might be agents are proposition that as to less not the that know value develop that for to be the pathways cell we'll work inhibit it shut would raw - hope inside it resistance would study interested through we'll two allow shuts any pathway.

Kumar Raja

Phase sites also X expanding going that? the for And of in you are number terms to the be of

James Breitmeyer

are. Yes we

adding five sites of - we have we're in the be on additional open We the moment. And XX at right sites - we'll are now. at process

Kumar Raja

we’ll that quick expectation like a the be enrolment? would have So probably

James Breitmeyer

repeat the you Could question?

Kumar Raja

very enrollment we see Enrolment X quick portion? in can Phase that the expectation would a be

James Breitmeyer

enrollment guiding on Well complete not of amount to we're time the yet.

investigators among will level We a have we that far. for the have the we just so say a good enthusiasm that opened our study. I randomized the seen of good results of have But part

Kumar Raja

Thanks taking questions. my great. Okay, for

James Breitmeyer

Thank interest. appreciate your you, Kumar. We

Operator

at call to closing this for I additional are There over questions time. Breitmeyer would like to turn back Dr. no the remarks.

James Breitmeyer

us Thank you cutting-edge on Everybody, for you first science. NASDAQ a company. listed diversified joining Oncternal thank based a Oncternal’s very call earnings for has quarterly much, pipeline as operator.

developers. a strong board composed of have serial We entrepreneurs drug management biotech and experienced and

announce year programs for from of randomized We next combination with including lot later ongoing to our have in today. patients work into data We this Phase for that cancer. hope and sharply of focused clinical progress realize additional promising expect and cirmtuzumab ahead year, Thank science the joining our study you are with we a ibrutinib. X us on turning our and

Operator

conference. today's concludes This

You may disconnect your Thank for participation. lines time. at you this your

Oncternal Therapeutics (ONCT) 11 Aug 192019 Q2 Earnings call transcript