ONCT - Earnings call transcript Q1 2024 | Oncternal Therapeutics, Inc.

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Operator

Greetings. Welcome to Oncternal's First Quarter 2024 Financial Results Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Richard Vincent, Chief Financial Officer.

You may begin.

Richard Vincent

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

the Yazji. the Joining the and are Salim next of quarter a ended under call results today's of our our release days. Please XXXX call for were discussion on call Investor update our on call and business President Dr. March Breitmeyer; Relations Reform afternoon Litigation press replay available website today's section Private a the first James certain and at filed the this that be least XX me earlier note on of Today's includes provisions Dr. information and CMO, financial Oncternal's of XX, This that will CEO, today. Securities Act. safe discussed harbor covered is

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

materially is the to as circumstances Jim revise date statements call undertake XXXX. to release forward-looking pleasure Our forward-looking full business. These and XX, these qualified cautionary of We after or events of Form only filings, our December and This live that, in ended our actual year the with this date and results could conjunction considered reflect uncertainties our call. With our associated with or any accurate filed SEC the press broadcast, to information call statements from to update those statements time-sensitive XX-Q to Dr. in it the Breitmeyer. due forward-looking of X, for today's today the are or is my should risks and be by statements our this XX-K by contains implied obligation stated over including hand no contained differ CEO, XXXX. Form occurring filed May previously that

James Breitmeyer

clinical and inhibitor, patients. engagement first-in-class pathway AR, by the demand and portion interacting At for and high variants splice many with many with Oncternal, to programs advancing ONCT-XXX, action through afternoon, is terminal such ONCT-XXX abiraterone, significant from of as patients X DAARI, we needs. KOLs, Thank unmet including domain AR-VX. are Phase receptor and address advancing believe and domain everyone. escape ligand or the good inducing see continue receptor We escalation the inhibitors, we dual and and enzalutamide may medical study, as binding investigators I/II degradation mechanisms targeting you, dose Rich, and rapidly cancer novel the such and that of the of both prostate approved mutations androgen by AR to cancer LVD the our

the opened recently top centers I/II enthusiastic. study and are to Phase investigators several the have academic We join

program clinical antitumor preclinical those be may XXX late ONCT-XXX dose to the optimistic of fully committee ONCT-XXX analysis, participants dosing of date, treated the second initial third ONCT-XXX dose Based per are cohort the the announce year. within happy an fourth after including enrolled. We receiving level to day that study the in update study at decision from quarter patients also study's The active daily. are data now of this that for move receiving made by to the dose data Patients in on was range that this doses to milligrams cohort once milligrams We to orally. this are level of are safety of for plan share we reviewing activity. is review the XXX this

investigators the or in CDXX failed Now to who B-cell are switching patients CAR have our patients. doses. Phase study our We'd enrolling previous to team lower for which happy and is gears implementation relapsed evaluating protocol include and and modified of treatment again we with monitoring criteria, swift T patients infection eligibility lymphoma, that RORX to targeting also the increased for aggressive open the ONCT-XXX, autologous refractory CAR-T, including like amendments, thank announce I/II

an T X initial of encouraging cells date. and response as at recently a dose. As X metabolic patients December With CAR the achieving kilogram XxXX^X a signal per we the complete the achieving third, of partial reminder, response shared response X cutoff

from Rich now We the I expect dosing turn clinical to including in patients the schedule CFO, updated results, report call mid-XXXX. With will Vincent. to with Rich? new this, data back treated our

Richard Vincent

Jim. you, Thank

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

was grant $X.X the revenue Our for million XXXX. March XX, ended quarter first

XX, the were first share the first loss $X.X million compensation Net basic ended general million. and and $X the totaled $X.X quarter, and million million $X.X including for was in for per million, quarter noncash loss and totaled XXXX, stock-based administrative fourth development a research expenses quarter operating of $X.X total $X.XX In expenses March Our expense. for diluted. expenses

outstanding, $XX investments the XXXX. million short-term remain believe track and of With had we sufficient debt. cash forward for of cash, milestones, quarter shares respect fund significant points. XXXX, As into million March will and on operations of XX, in stock our approximately towards programs we first We these data common funds moving equivalents both upcoming be X no to to

we to data will fourth readouts expect XXXX. With fourth Q&A of the in we For XXXX, expect ONCT-XXX, with our in I part the portion XXXX. of with ONCT-XXX, of to that, RORX data operator of CAR-T, DAARI the second for quarter back afternoon's our in update present lead of in the product autologous things quarter clinical report the this turn initial to latter data quarter readouts additional the a additional mid-XXXX candidate, clinical call.

Operator

the [Operator first Please Markets. Northland Instructions] what's question. of your from Our Carl Capital proceed line question comes Byrnes you. Thank with

Carl Byrnes

me, respect I you your expect you prior would that dose higher into your in on suspect full dose dose With many had XXX also, in that progress. of enrollment the excuse do cohort. you the update. the were go that How XXX-milligram then in And get cohort? end XXX you -- in congratulations mid to And escalation you that mentioned would -- think to to study, terms --

James Breitmeyer

Salim have we'll that So answer question?

Salim Yazji

Yes.

X this We're to fine, then which in period, of the SRC fully if everything cohort towards in end And So escalate is is to and XXX this have expect actually, cohort. months DLT patients we're the already actually. next month cohort, happening we and milligram. will mid-this a dosed this dose enrolled the still

James Breitmeyer

Yes.

So cohort the on announce some Carl, that time runs from we by have everything we data assuming track, XXX-milligram results. would the

Operator

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

Hartaj Singh

academic Jim, is that line, ARSI a responses too data -- given got again, XX% the second suggest. about ARSI just to questions. about is, receptor seems after question like to signaling And on is, early the going bit how cancer. literature given to I of see higher, when a with seems that? it think follow-up Is current line just XXX? with got RORX. the update to I could Is but a little quarter way on second first prostate what couple molecules that and are the And it redosed, your quick happen the that's then One in maybe got back you've death these just

James Breitmeyer

that Sure. question. I'll take And

expecting. to for be to respond in fact published androgen includes receptor at domain data So existing abiraterone we're on enzalutamide the address. if Because, inhibitor would binding the to the the from example, switch of one developed what have second I you another that to the ligand signaling that cannot agent the switching failure mutations from end low think that the abiraterone,

-- in resistant So XXX active to are is we is our cancer that for enzalutamide. -- against, case, does example, prostate

active cases therapies against than have in ARSI active more it binding switching not entirely, you be the and variants, So hormone-related splice those do would all. which one from expect We're from conventional at another. lost to also ligand would respond domain to

Hartaj Singh

in is CRs color the December? or then question Is you just And those updates RORX. provide you any of on other that X the on Great. can durability there saw

James Breitmeyer

-- Sure. wait, you has to comment? can speak Salim, want do We're but you to in know, generalities. I Hartaj

Salim Yazji

Sure.

we're into CDXX those well cohort CAR-T of treating know, multiple go been and patients in CDXX some we've as failed prior you So therapy, as But treatments. going not as that the the prior the including bispecific details. who patients X, them to

So survival. short is low the these patients. heavily very expectation of are progression-free and usually, pretreated And very and those patients

So taking to about durability tritiated we what enthusiastic patients. of we that but I very question, about we consideration the the seeing response, are are think answer have heavily your very sick,

Operator

comes of the question Robert H.C. line next from Wainright. with Burns Our

Robert Burns

progress. Congrats on the

Just for X questions me regarding XXX.

how who trial at I patients was So you're would it's whether safety And regards I do a the then going only are Or in targeted or you are to to failed profile trying modified -- in ineligible try T. think eligibility the from CAR-T criteria, design, are Phase that know CAR that -- broader a also for CDXX which current to that those explore more that, II? the perspective? with help secondly, population? in is you I CDXX to go you CAR-T for curious looking Phase

James Breitmeyer

me let with can start question, from I So Rob. the -- safety the --

-- toxicity And some to patient patient you're escalation. for X learned case the study, we can that rest in had we a in that the we asking. we're grade which improve overall we -- we is to So a responding safety use the of are things the dose unfortunate earlier of think what about

of years any cells infection age example, was old. disease, know because have the the limit we're kind is no We're which #X upper by as B a of we cause bulky to CAR-T number patients obliterated for undergone I'm were death the well, who patient have and measures of to CDXX patient a had sure therapy. detect their treated try therapy had. cult allowing that infection, you they've longer So in lowering which, taking And XX that non-tumor

feel study. measures were the So into already to the built measures are that -- will with these we that the do X add many safety these

Salim, -- have for going I've suitable question, So forgotten your it first -- except was. and I'm were to what

So it, please. repeat could you if

Robert Burns

Yes.

Are CDXX in the first CAR-T for unmet failed you're there? the population I considering thinking about for And So looking I also at know that only I. the portion, that's specifically, patients. allowing Phase Phase -- need the you given in

Salim Yazji

Yes.

we -- know, the as but you still are learning I, So in go. as we actually, are we Phase we

patients in think in I. patient population. from see we're yes, going what we to your those Phase we're I going we II, think the probably as probably And signal the I the that a to to expand I, based Phase population see Phase expand question, if answer on

James Breitmeyer

required protocol either -- the CDXX ineligible failed or Phase II, have in CDXX I. And patients Phase are who allows or to had CAR-T it who in while failures Yes. FDA refused people us had

restriction So Phase for X. removing that we're

Operator

And Capital of Kemp Brookline question comes next our Markets. the with Dolliver from line

Brian Kemp Dolliver

decisions, those the based you've on market data enrollment are whatever estimated? but that thinking is on, the that looked And any addressable continue at discussion of in you XXX criteria. around making other a have the had just notice early with and the to difference how this previously admittedly, changes And made you does -- you on

James Breitmeyer

And we changes Kemp, market. criteria thanks the the modified eligibility don't question. think that for the no, addressable

Operator

Thank remarks. Breitmeyer for turn James question-and-answer back you. And end session. of reached the have we over the And call I'll CEO, now to the closing

James Breitmeyer

clinical Thank you We're forward for to these throughout significant look potentially the studies. pleased and you, us very XXX updating execution today, programs for Shamali. in data clinical updates in Overall, looking and you Thank of year. for of we and both the and coming both we XXX joining months. pace the to forward the investigators with are enthusiasm programs, encouraged our our

Operator

Thank and you may lines And time. this today's concludes conference, this participation. disconnect you for your your at

Oncternal Therapeutics (ONCT) 9 May 242024 Q1 Earnings call transcript