ONCT - Earnings call 4 2023 | Oncternal Therapeutics, Inc.

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Operator

Greetings, and welcome to Oncternal's Fourth Quarter 2023 Financial Results Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

pleasure your my Chief Richard now Officer. Financial is to host, introduce Vincent, It Richard. you, Thank

begin. may You

Richard Vincent

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

me of Salim year Yazji. our call includes and afternoon James Joining full update XXXX. and for Today's call and the business CEO, quarter discussion Breitmeyer; Dr. and results Dr. are CMO, our a the on our President this fourth

replay for press of full the XXXX filed release year available and Today's the days. of a the call Our Relations XX-K for XX on today's earlier was be at will section today. next Investor Oncternal's least website

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

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

could and today. materially business. our filings, implied actual These Our our in stated XX, our should are in XX-K to forward-looking statements forward-looking with cautionary statements ended conjunction or Form year the these statements filed SEC by for be differ and associated due considered results risks uncertainties with from those full XXXX, including release press as qualified December the today's by and contained

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

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

James Breitmeyer

significant At clinical patients targeting programs cancers are X you, advancing with and need. we Thank Oncternal, medical good everyone. for Rich, afternoon, unmet first-in-class

cancer before move mechanism continue action, or prostate aggressive may to into therapy need and treatment currently options pathway which a of therapy. novel ONCT-XXX chemotherapy the its they such for be significant advanced who approved of AR patients progress inhibitor as unmet We address potential and after about excited more radioligand

patients have announced castrate-resistant of we escalation/dose into year, cancer expansion metastatic with our that prostate this enrolled Earlier ONCT-XXX. X Phase I/II study dose been

We of quarter. third of escalate now plan dose milligrams without ONCT-XXX and cohort fully this to initial next dosing been for as to unexpected dose-limiting XXX the enrolled. clinical is toxicities, an have able program data update announce late We planned

With cutoff cells X who CDXX or the per and with with I/II Grade autologous dosing to Phase Common patients X in patients an CAR initial CAR as we third syndrome, previous dose X this complete data in study B-cell of signal metabolic RORX-targeting ONCT-XXX, our therapy. date. have response the CAR kilogram T, refractory XX^X X-X December failed released We Xx response achieving blood T events relapsed of cytokine achieving clinical December adverse response in the included cohort ONCT-XXX-XXX of patients and decreased partial including pneumonia, saw aggressive respect lymphoma, or initial a from CRS. at T encouraging the counts, release

prior were an lymphoma the including serious at T, ONCT-XXX. masses neurotoxicity experienced CAR adverse and with level CAR no despite X present had CDXX treated kilogram, syndrome. previous bulky his evidence event of patient histological tumor fatal cell-associated X with to The CRS therapy, dose who of of fact consistent large XxXX^X with the cells treatment received patient's first a showed immunofactor This there autopsy that lines per XX-year-old T disease

adult criteria, lower event of this additional and in we and to alignment including ONCT-XXX FDA, for result unfortunate patients further investigate screening who T the testing B-cell believe of modified relapsed changes lymphoma, with CDXX decided optimal infection, for have us as ONCT-XXX. safety with include patient We that help the of ensure after a these will dose treatment. implement doses protocol we advanced CAR changes eligibility As additional patients

results, expect clinical report We to for ONCT-XXX this mid-XXXX. in including updated from new schedule dosing

and forward points are for ONCT-XXX, to near advancing, we programs, Overall, value our in from inflection looking term. significant are and potential X the programs both clinical ONCT-XXX the company

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

Richard Vincent

Thank you, Jim.

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

for ended revenue quarter $X.X the XXXX full grant Our for was $X.X XXXX. million the and XX, fourth December year million

included million, quarter expenses in fourth which were operating million million expense. total expenses year noncash stock-based expense. were operating the $X.X Our stock-based which compensation included $XX.X noncash in $X.X $X.X for Total the million, for compensation full

quarter, million, $X.X In administrative research million. and general totaled totaled the fourth and and expenses development $X.X expenses

totaled full year, $XX.X expenses expenses development $XX.X research totaled the and administrative and and million. million, general For

Net loss and for or quarter fourth loss $X.X basic $X.XX was million, share, the of a diluted. per

million, loss the a share, $XX.X was For our full year, basic $XX.XX or net loss and diluted. of per

million cash, fund operations with X.X in stock of million to these XX, no outstanding equivalents our shares and As investments We December and cash the of of first will quarter debt. common $XX.X we sufficient be had short-term into believe XXXX, funds XXXX.

on With remain milestones, upcoming track. respect to we

additional lead in we fourth quarter For data XXXX. data readouts ONCT-XXX, product clinical DAARI expect candidate, to late the second our of XXXX of in quarter initial present with the

additional to mid-XXXX of quarter XXXX. our with fourth a ONCT-XXX, data CAR in T, clinical autologous the expect we report data readouts RORX update For

over Jim. Now I turn to will the call back

James Breitmeyer

Rich. Thanks,

questions. -- questions So, with up to you take floor that, see if ready for think open the could I Alicia, are we

Operator

Of course.

We a will now question-and-answer [Operator Instructions] session. you. conducting Thank be

Capital Markets. Our first line of from question the with comes Byrnes Carl Northland

Carl Byrnes

would that just was be late on data quarter XXX-milligram the you as Congratulations is when second on to your expect the going the cohort? have in when dose? a well. And you through XXX, dosing I then Program I And to have update wondering follow-up then if, begin the progress. XXX-milligram

James Breitmeyer

Thank Carl. question. the for Sure, you

be speaking progress the by and dose the we end about we'll the of -- of are both to dose difficult XXX-milligram predict at second hopeful accuracy, the able So is of be XXX-milligram with we'll -- trials to quarter. course, that clinical the but

Carl Byrnes

you update starting very helpful. Obviously, screening provided mentioned are probably in that And it's what moving dosing terms then to infection the I like. Is you That's and escalating specifics dosing -- criteria, be for XxXX^X. at, you is? XXX, Have then the new going know of of schedule. that over also to like significantly somewhere an X.XX on schedule new there? below and from then eligibility

James Breitmeyer

right. you Carl. you, And the to that's want do Thank schedule? dosing exactly new discuss Salim,

Salim Yazji

Sure.

if will as have the because schedule as between academic actually on with X then then SRC we that's the the are in and anything dosing dosing treating and be PIs those want -- X SRC who's physicians making patients do to and the then independent based, dose the X. level physicians. an decide CAR the study SRC the And decisions. enrolling is X.XxXX^X Carl, with And So will T results, be company an X.XxXX^X. well will next start it they And and can who

Carl Byrnes

Great. Perfect. That's very helpful.

Operator

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

Hartaj Singh

leaders, action there's need One got bit to for calls opinion indicated just about mechanism such is I've of key in to some a done little a the maybe Great. a in we've would high dig us have in with just the couple. earlier unmet area of that ONCT-XXX. they a what in questions market. size if genericization be can TAM you pricing? market some give Because of of cancer. terms and even metastatic idea the kind looks that is an there of prostate what potentially, Rich, the castrate-resistant like In

thoughts couple there? then a any follow-ups. And got Just I've quick of

James Breitmeyer

Hartaj. for the question. Thank Sure, you

market options. So X in there's different X -- sizing we've been penciling

failed pathway believe it for we is that -- if first disease or $X be receptor available is who would a who more an billion. sales -- patients -- And and in used a failed there who we have if do -- have androgen near The or available $X that metastatic potential billion is of inhibitors. potential a have drug one are

are drugs other of some on receptor. very are mutations unlike ONCT-XXX that the receptor, focused expressing and know, cancers you androgen as active also in androgen is against the native development But

therapy, potential lines move as means hormone-sensitive So, into has prostate to it that the earlier that cancer. of such

kind indication, And a an of with can multibillion there's dollar so you potential. as that imagine,

Hartaj Singh

Yes, helpful. you're just the at our health XXX the into Oppenheimer you few last being amendments a actually indicated next you've trial? IRBs. data any getting then to that Conference, had When the I seeing talked set we I that, recruited question patients had the updates, Jim, just back time know to the just XXX. thoughts ago already And for Healthcare that's could care conference start the other we there? on going but lines very, weeks very know is the time

James Breitmeyer

Absolutely.

study. the have to our investigators, into So our physicians, been want we're in patients to very treating that eager the And are get get on study. very that investigators the several patients fact, encouraged identified principal

be their sites their at study can they approval treated. that everything the that expedite doing are can of so amended they so And to the patients

So, going that too to not take we're optimistic it's long.

Hartaj Singh

last your side. what were just little you've to is Great. Great. XX% looking you the be pretty Rich, expecting. And below Thank then you, question And know generally at bit, a tends OpEx I in fourth to also? R&D we came decent a for quarter what -- runway seems your the guidance the be next on burn, heavy were think cash Jim. forward almost million your expecting. reasons what then sort we to just about that it And the $X that than given was going less it way are your is into But year. already

Richard Vincent

fourth keep down the quarter up under than very that time did looked work brought came frame. very believe the wrapping kind primary were a QX in earlier ZILO-XXX like. efficiently, lot We and of were the is to costs to that of significantly in and the those the we original And reason forecast that we compared able program, we we in-house what actually the because planned,

of really study. majority last for costs holds there really ZILO earlier year. the true I/II think that Phase are for this the the good the I ZILO-XXX down and of that behind chunk patients and program treating So, costs even us, a winding the We're clearly

Hartaj Singh

it. Got

realistic the would I cash be So mean next through $XX basically per $X million burn quarters? few quarter million the to

Richard Vincent

noncash in to million million $X that the mind million compensation Well, expense. roughly $XX $X-plus keep included of stock-based

million to to the kind of $X closer up. as range enrollment it's $X.X So, ticks million

Operator

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

Brian Kemp Dolliver

couple Great. A questions XXX. of regarding

will X patients at the So, how on you've program dosed so dose. the XxXX^X just to proceed, be clear

it XX the sounds each, the then dose you should higher will deciding And you would You're down have to cohort do dose a you like if up will up going such you whether dose? time at potentially that, to the go to a before X initial to first go - patients second and second. dose patients move you

James Breitmeyer

Salim?

Salim Yazji

Yes.

X the So we before first again actually, decide I X.XxXX^X which will into said earlier, go above dose we the between X earlier, and or the is we we decided X we by the tolerated, new intermediate And if X next X.X, and cohort. mean, the an do X. to as and I added that said know, into because, I SRC, to be we was is evaluate and will this what X cohorts want that you want as moved well

X.X, to and I we're decided what into So, from based more that on X or we're to X. X.X intermediate will see add between patients be think, dose X do the going going and an if

Brian Kemp Dolliver

X comparable? potentially Is Okay. data protocol because -- significant be the at dosing wouldn't And what's the changes are the reason enough for that it again?

Salim Yazji

patients that's there X.X, more multiple there's predict the from I start but And do mean, will the reason And tell think and us depending see, will to data what the and SRC I mean into decide. will the on to X. will at but why all No. then be I be going seeing new toxicity some probably cannot going X to we will I to meet said it's we're we what want reasons add if I cohorts. that, only

Brian Kemp Dolliver

And with regard IRB are FDA? That's approvals awaiting approvals the are or that Okay. fine. you the remaining, to

Salim Yazji

FDA actually done to changes. have things the decide everything the as we the -- the protocol again. we before awaiting enrollment No, the last be to logistical some And of actually, to with was about the be got we're submitted just IRB and initiate agreement that things

Brian Kemp Dolliver

sounds it probably 'XX, about small Richard, there but less. Okay. that amount of be expenses fair assumption? we're a Got And a Is in for number X-digit zanubrutinib will like it. or a talking

James Breitmeyer

Rich?

Richard Vincent

That's close.

Operator

at questions back this to Thank for remarks. the turn Breitmeyer to closing James Dr. floor are further you. like no I'd time. over There

James Breitmeyer

you, Alicia. Thank

advance programs to clinical while XXXX. points cash runway towards clinical into inflection midyear, by our We our guidance reiterating data significant continue X

or novel unable harboring lymphoma of aggressive medical to We high with refractory patients B-cell relapse, clinical be patients areas need, are T excited advancing with very specifically development to and CAR who are the with androgen castrate-resistant mutations splice therapy. metastatic pathways prostate obtain in receptor and variants unmet cancer CDXX

throughout joining forward to the you With year. that, thank you look we updating Alicia? and for today, us

Operator

today's you. Thank concludes teleconference. This

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

Oncternal Therapeutics (ONCT) 7 Mar 242023 Q4 Earnings call transcript