ONCT - Earnings call 3 2023 | Oncternal Therapeutics, Inc.

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Operator

Greetings, and welcome to Oncternal Therapeutics Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

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

Richard Vincent

Rob. you, Thank and everyone, for us joining Good thank today. afternoon, you

Yazji. the Joining and are Salim call our on our President Dr. Breitmeyer; afternoon James this me Dr. and CMO, CEO,

discussion next section Today's will on of the XX, call at be days. financial were release available Today's that of the for earlier results business least of and includes update a XXXX our quarter replay Oncternal's ended a website third XX September today. press Relations filed Investor and today's call

Please the on under note today's call the safe certain information that discussed Litigation is harbor Private Act. covered provisions Reform of Securities

and making We studies, planned of data product be events strategies, cash the such updates, this our interim of our the forward-looking our will preclinical call and development about initiation future regulatory clinical statements during runway. of filings the timing and business timing timing as our of

by due with actual could or differ materially from uncertainties associated stated those and statements these implied our risks Our forward-looking business. results to

forward-looking and XX-K statements statements ended press previously today Form be today's our and full with the including in contained the conjunction release qualified and in by December SEC Form are XX, XX-Q cautionary filings, filed our filed These year XXXX. for our considered should

or revise call. that update the accurate broadcast, to to of undertake any call live contains This forward-looking time-sensitive information occurring of or events date date We reflect obligation is circumstances the no this only of as November XXXX. statements after X, this

call Breitmeyer. CEO, Jim it is over hand my to that, pleasure our the With to Dr.

James Breitmeyer

novel clinical I/II dosed are action October programs androgen medical Hello? we our At with needs. we our patient first-in-class Phase In receptor. dual of dose and targeting X in first significant you, good patients Rich, study ONCT-XXX, Thank everyone. advancing unmet Oncternal, escalation afternoon, cancers XXXX, our for now

Richard Vincent

Yes, you're back.

James Breitmeyer

AR pathway after ONCT-XXX important in patients that our approved Track inhibitors. belief patients from be Fast supporting prostate castrate-resistant we also with ONCT-XXX I have Thank who progressed calling therapeutic you. I'm prostate October, everybody. treatment may is received cancer for Okay. advanced internationally. for cancer. Designation apologize further alternative with metastatic with FDA, In an

initial We data the XXXX. our clinical first readout of half expect in

CAR-T ONCT-XXX, enrollment execute to our of study RORX the I/II With continue patient. targeting B-cell in non-Hodgkin's autologous respect program, Phase we to on lymphoma aggressive

few times. in We year data December have high-quality the may with XXXX. plan delivering now of numbers clinical and in clinical is dosed readouts and announce first of to CAR-expressing-T this initial manufacturing cells reduced vein-to-vein additional process large offer The patients

to while programs, runway the are on of our through advance plan clinical half XXXX, Overall, inflection XXX our containing XXX value we X our into guidance cash by delivering and significant all potential first point XXXX.

now to XXX clinical on XXX. turn like with I'd to Oncternal Salim? Salim progress the CMO, Yazji, our expand call that, With to and

Salim Yazji

Jim. you, Thank

pathway inhibitors, are mentioned, have ONCT-XXX-XXX. Jim of progressive that to metastatic to androgen or A such castration-resistant enrolling our Phase patients we studies to disease in relapsed As receptors have cancer enzalutamide prior with dose abiraterone. refractory posted with study -- dosed the excited first that escalation are or I/II as have patients

amplification inhibitors, novel by patients results mechanism and AR-VX. to alternative escape resistant mechanism, as addressing believe such pathway a preclinical tumor important an variants AR studies that of currently including its provide mutation, Based treatment splice we to on can ONCT-XXX [indiscernible] AR available and key that action, in AR

of the London, from Yu the Dr. Professor Dr. Hutch. ICR data Scientific continue according half from we first is plan, we as Advisory Fred in to Board, Evan the leaders cancer from distinguished the the academic Johann and and Mass our prostate Bono, includes XXXX. industry In announced Smith in such initial Matthew to General establishment field, September, and to which cancer prostate Enrollment report advancing of expect in de

targeting We with continue to ONCT-XXX, strategy for autologous SAB this look our ONCT-XXX-XXX, including ONCT-XXX. I/II clinical Phase to escalation relapsed RORX registrational for develop to dose and our aggressive those -- with With respect forward we to refractory B-cell in CAR-T, patients working our future failed lymphoma, of CDXX in a therapy. or portion study our who the previous study patients dose have CAR-T

have CAR-T which with correlated previous encouraging and demonstrated Studies. expansion We CAR-expressing-T study, in been be cells the seen response CDXX positively persistence in of clinical has to

Rich? Vincent. this, the to With CFO, turn I our now call Rich

Richard Vincent

Thank you, Salim.

research revenue from and Our received NIH. the from development grants is derived currently

Our third $X.X grant ended XXXX. million for the was revenue quarter September XX,

million million third and $X.X $X.X in quarter million, noncash administrative general were Our development $XX.X expense. the expenses total million. compensation and expenses and expenses stock-based including Research operating for $X.X totaled totaled

million. Interest income $X.X $X.XX the quarter for or of a loss basic was and Net share million $X.X was diluted. per third quarter the for loss

sufficient September of of cash funds million We to XXXX. operations in our million $XX.X and we and debt. As stock outstanding, XX, had be believe these XX XXXX, fund shares common into no will investments

upcoming remain to track. we With respect milestones, on

ONCT-XXX, CAR-T, For we readouts in report additional clinical December to in RORX initial data data XXXX. with expect XXXX autologous our

product first to DAARI of data present half late candidate, clinical we XXXX. our expect ONCT-XXX, initial For in the

turn back over to the call Jim. will Jim? I Now

James Breitmeyer

Thank you, Rich.

are We guidance clinical recent XXXX. progress very our with programs runway reiterating in into while our the pleased X cash

of the mutations relapses castrate-resistant high prostate metastatic as aggressive pathways excited unmet clinical areas hybrid advancing splice are in very and CDXX novel and in lymphoma We variants. such medical to cancer, need, be with development AR

and we upcoming you you that, With to afternoon's of for forward the things conferences. medical during Q&A this will turn back today, call. look to Rob for updating I us joining banking portion and Thank

Operator

Byrnes is question first with Northland Our Instructions] Capital Markets. Carl from [Operator

Carl Byrnes

with I'm a urgent escalation to considering patient and the detail can on provide recruitment more you wondering progress. then study. XXX indication. congratulations the if And respect I is little this need dose of unmet have obviously velocity follow-up. a medical your And Also, the

James Breitmeyer

Salim. ahead, Go

Salim Yazji

Yes.

cohorts with know, those during there toxicity has cohorts. only X side So first we allowed X on if based no the or us design, patient with as study forward each Boeing move effect the the you to designed is which

So, I mean, the I is everything think good enrollments expected. and as so far,

James Breitmeyer

Carl, there these And there lot there. out a are are of patients

Salim Yazji

as was It should like seems in you easy I [indiscernible] trials these they And that's enroll. to advance, going. where be relatively Yes. progress

James Breitmeyer

We're -- we hope so.

You we're if are a our is number both finding and the seem in for -- their unmet patients to the that But investigators are with who pattern. kinds of never enthusiastic need be what studies, ample of know. good enrollment systems these

Carl Byrnes

little CAR-T of there therapies? signal on Phase recommended data relatively And shifting level terms readout dose thoughts Do then you close any in efficacy just to have a with Excellent. being bit considering the in of potential the December, gears XXX. other II doses the

James Breitmeyer

that one, take Salim. I'll Yes.

as CAR know, quickly. to X responses [indiscernible] lymphoma probably aggressive that think X you months. And CAR-T I with think into and I CAR-T, [indiscernible] -- pretty have

between similarity [indiscernible] if So [indiscernible]

Carl Byrnes

think you bit. I Jim, sorry, broke a up I'm

James Breitmeyer

I'm I Yes, Can you did. hear better me now? sorry.

Carl Byrnes

Yes.

James Breitmeyer

Okay. I just switched phones.

develop So responses December. have that about given that shown to we we're in efficacy that some other can may quickly, CAR-T optimistic complete programs have talk

Carl Byrnes

Great. the Great. progress. congratulations Again, on

Operator

Our next question comes & from Hartaj Oppenheimer Singh Company. with

Hartaj Singh

you nice of see, What Things quickly, like are acceptable a durability update. these just and about to is you're XXX, move would And like do along be on in other you X, you'd forward, follow what the questions. minimum Salim when then dose Great. amount and efficacy moving previous then guess on X XXX, team. pretty to that or patients like you as Jim And level again, move whether X, expansion, one dose the it's questions. I to -- are an order Really there you to following in thinking on program thinking you just terms forward. a see up question with onwards. [indiscernible] similar of

being moving there the from for data You're lot dose early that to the dose presented expansion you're be going close to of sort escalation should getting a a we part stage. to to of us What of have [indiscernible]. that signals looking

Salim Yazji

do Okay. take want to Jim, this you me one?

So Hartaj, establishing actually start connection. can probably Jim the while I

-- very with prior survival even short, we sick patients, relapsed from know, you I in Unfortunately, after are mean, is As is usually survival really months, overall patients the which very these who especially years. CAR-T. progression-free CDXX patients, and not dealing

also those failed of CAR-T. we'd some And And as populations be would a response already to response will patient question. see response. prior that's big and good a durable durability what expect, in What that we objective expect

objective survival survival rate the to of because evaluate see I it medium more still that and currently some very no there question, need is progression-free no months. think X and and months we a is more usually data it's than X than

very best. So and for I think very we are really sick dealing with hoping patients we're aggressive but the

additional So questions there's ones from will take if any you, Hartaj? here. I'll stop I any

Hartaj Singh

got oral where Salim, It that's I guess, what really how mean, just you No, right? I it -- be see? to think you can good. way go get Did need before then all go all expect you'd no. -- -- to to on question. do seems could could like when the week daily, that? do and XXX, my but milligram do [indiscernible]? -- XXX? expect to you we you've you the think XXX that's And I And do you before to

Salim Yazji

will our will be I it dose to things we therapeutic be -- go the dose and -- cohort. actually side seeing depends, think responses it the from the will a time But XXX hoping that. also in how fourth that, maybe or think is be We to able see will dose the I mean, believe will start see do can if all early earlier that we and and than on to I But efficacy we're start fast on So escalation is there. we cohorts. may actually above earlier it's any which that --

James Breitmeyer

add me let And something...

Hartaj Singh

Yes. Jim, go ahead.

James Breitmeyer

Yes.

and early learn than at they there efficacy explore below they're for here FDA what's last FDA MTD are look between to And week a a the not tolerated to conference to that and oncology, they establish clear Project -- they're between discussion in looking the where maximum encouraging emphasizing and safety. FDA -- panel addressed doses members very the what development just balance And in So Optimus. the safety. perfect that efficacy balance several to is is was SITC guidance dose particular, interesting and in more developers made for of

what this this to so dose discussed will that therapy, same particularly was cell context XXX, helpful but the being principles choice for of was as of apply -- the the panel such well. about ONCT-XXX it was in was And as

Hartaj Singh

before. probably this -- And I just know I Yes. Jim, you've guess thinking was mentioned I

level of why when again, dose do have the from the B dose X dose escalation levels, study. you us move dose you forward and remind A Just level part

James Breitmeyer

in It's randomization made exactly is what Hartaj. this possible, whenever FDA see for for And they the levels. to expect between It's Optimus. dose X they Project reason, that looking that clear

the for ratio more FDA risk-benefit safety by than you registration opportunity that and dose. to before examine will have study, a start X the So intent efficacy and --

Operator

Next Capital Markets. Brookline Dolliver question with comes from Kemp

Brian Kemp Dolliver

Great.

from I PSMAX, you've How that data how mean, would in is regarding what and data patient as So now the for that far thinking question and trial, setting, the you you And pre-taxane about And from we're Novartis opportunity know, commentary seen so which, any the expecting also same to relates be the which on XXX. is population. day setting. used these SPLASH presented based recently XXX? drugs the in are the

James Breitmeyer

Yes, good question, Kemp.

the challenge treatment the active the the that PSMAX a worse there analysis. is So slightly study is intent-to-treat in group from in survival overall

know so And safety be close their in FDA very looking we a data will manner. that at

to doesn't or And high desire treat oral with available, require have treatment to patients abiraterone that still different their enzalutamide there to referral the very option available cancer what prostate that option resistance we both and after a an is a specialist treatment to believe develop. another physicians a is for

So here a continuing. viable prostate commercially remaining in the and indication important we cancer have confident we're that clinically

Operator

to over the the end like of turn Breitmeyer closing question-and-answer I James session. back for to reached the have comments. call would We Dr. now

James Breitmeyer

you, and everybody's time Thank the questions Rob. afternoon. this We and good attention appreciate

of We look are end with to and forward touch in to half forward of exciting staying and looking year this you. year first an next

So will with for your we off. you thank sign time, that, and

Operator

conference. today's concludes This

at You for time, may this participation. disconnect your and lines your we you thank

Oncternal Therapeutics (ONCT) 9 Nov 232023 Q3 Earnings call transcript