- Earnings call transcript Q3 2022

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Operator

Ladies and chairman, greetings and welcome to the Oncternal Therapeutics, Inc. Q3 2022 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 Mr. now is to host, introduce It Officer. Richard Financial Vincent, Chief Please go ahead, Sir.

Rich Vincent

much, afternoon Ryan. you very you Thank Good us for everyone, today. joining thank and

CEO, afternoon Joining Salim Dr. on quarter will our call update release call our XX which call XXXX, results on business Today's least Breitmeyer, this a be discussion me investor President our available the and Yazji. will replay XX, and Q&A. at ended and Dr. press includes CMO, followed for James and of third are September of Today's days. section today's a at be for Long's the relations by the website next the

on the is under quarter XXXX covered for of Please the also safe XX-Q harbor note Private third Act. call information Reform today's Securities Litigation provisions is today. Our discussed the available that certain

statements making and expected a our strategies, such X and support BLA our be filings business updates, forward will study planned timing the regulatory ZILO-XXX initiation submission, feedback. We and our interim this of and looking events of future pre-IND timing potential of to call for as studies, the timing our of development submissions about product Phase during the the clinical pre-clinical

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

Dr. James Breitmeyer

Rich, and pipeline that At for medical we candidates focused Oncternal, target afternoon, clinical patients product with and a needs. and you, robust preclinical with Thank cancers are good everyone. unmet advancing

The a third XXXX quarter was one pivotal of Oncternal. for

trial we we patients First, mantle ZILO-XXX that announced ibrutinib the lymphoma. our of in clinical X study, Phase cell zilovertamab, initiated with

a multiple addressing reminder, play we a As pathway, hematologic is the in which therapeutic can ZILO-XXX important unmet solid for believe needs and tumor study in role key first RORX the indications. registrational targeting a

the announced lymphoma Phase or zilovertamab cell dose we a Second, receipt targeting have an which This May our submitting New lead of the study leukemia presentation Hematology IND for CDXX CAR-T who in our of Orleans of failed we XX December with with in significant morning as this chronic just that unmet this the accepted conducted be US Society in Also, lymphocytic will study Proceed letter in product days clinical year. Meeting results need. in treatment, a after oral trial B-cell patients with FDA patients escalation ibrutinib RORX. ONCT-XXX, application from of ongoing Study our plus those medical autologous represents American Annual XX announced were aggressive mantle at CAR-T a including from candidate XX Phase previous lymphoma,

and with study zilovertamab presented we We the and extending by this for at and are ibrutinib including PXX we progression-free survival ASCO patients updated to CLL data selection look that receiving alterations honored presenting first very encouraging forward results XXXX.

of advance DAR have towards continues expect filing pre-IND from December FDA androgen receptor to action dual program year. or the to the for feedback and in candidate lead our IND ONCT-XXX, an Finally, inhibitor we this

differentiated a domain novel domain be advanced that and the the with and We the cancer, interacts of alternative ligand we may for Preclinical receptor degradation. inducing treatment both it prostate androgen shown terminal believe relevant cancer. enzalutamide with data which treatment patients it and in are function splice its that binding activity as optimistic cancer ONCT-XXX ARVX, models, AR each with such androgen including for exerts or those prostate with need patients clinically resistance, ONCT-XXX unmet significant variants as resistant anti-tumor amplification, a represents receptor of has prostate inhibiting medical

cash our currently and operations into estimate available. front, can focus we and half XXXX corporate we with on vigilant first the on funds we execution the we continue fund resource On as our remain usage, our of

to study XXX over autologous inpatient the discuss our for our study, call the the plans to the Yazji Let inpatient study status CAR-T now first of me of of and Salim? Ontario's CMO, ONCT-XXX. I'm Salim X turn sorry, Phase first

Dr. Salim Yazji

Thank afternoon, everyone. Good you, Jim.

We that is our are ZILO-XXX study X very underway. excited Phase now

target. site activating the year. will meet We we will We outside States United the XXX sites are XX estimating, of key first in open expect in goal, a are as role quarter focusing open play we and these regions on enrollment in to achieving sites to sites around believe a world of the this next to our between we first

presentation very study that this year We at December. Phase the are to ongoing excited our announce abstract XX XXXX was also for all in upcoming accepted the from our ASH

autologous to targeting turning lead candidate CAR-T the our of RORX program. ONCT-XXX, Now

with and was endpoints. in PK study the and able partners, and we into the Institute that and CAR-T Cancer safety support submission to the we important to of We efficacy X facility for will those cohorts, in and trial key plus in efficacy, its taken cell this have us Phase would exploration to ONCT-XXX cleared their expansion expect Biotec will helping evidence and cell dose. I XX will manipulation previous the core FDA be account patients -- evaluated dose thanks Miltenyi both results three achieving IND The Lentigen, efficacy dose the on be XX will a Phase aggressive milestone. failed initial and be the including safety in additional recommended escalation, be select treatment, report lymphoma, three days, dose escalation Dana-Farber our to are that like and excited our by After

Phase XX expect Rich study next the of Rich? over to to our later XXXX review to I the data and CFO, initiate quarter and We to our ONCT-XXX will expect financial call first in milestones. year. upcoming now share for initial Vincent, the turn our results

Rich Vincent

Salim. you, Thank

awarded Our the to from NIH. revenue two grants activities the is grants ONCT-XXX the two company $X.X of and Health support development of programs. the XXXX, and derived third for and for preclinical development company's National or from research up the NIH to In research million Institutes quarter ONCT-XXX

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

Cash the million million, our XXXX issuance XX, of and basic non-cash from which through of million, our diluted. $X.X agent. development million $XX.X for or totaled $X general sales from expenses nine administrative expenses million operating per quarter with was program $X.XX expense. loss Jeffries third generated quarter activities the totaled ATM $X.X was including $XX.X stock a total share the compensation of under September common ending September approximately loss million. $X.X Net expenses and and and as the Our pulled ended based shares flows second Research was in million months for financing XXXX $X.X XX, stock

the no $XX.X our cash activities equivalence to XX, first cash believe As support million of from we sufficient had XXXX. operating and XXXX, in half into planned We will these debt. September of be funds

cash man other will continue We to have resources and all our and deliberately.

US to and our XX, sites XXth As an with the American stock for at common shares update had first Exposition XXXX, and CLL of outside study to December, $XX.X program, Meeting Society provide our the X upcoming XXXX, clinical plus of of an and oral to as September perspective quarter Zillow in global we of for of patients outstanding. Hematology million open the zilovertamab, XXXX. in our in zilovertamab of Phase milestones data XX from expect interim With presentation ibrutinib Phase Annual study, registrational MCL we XXX

For ONCT-XXX, first B-cell data Phase XXXX. lymphoma patients initial the candidate, RORX cell therapy study an initiate present XXXX in in and with XX readout autologous in of plan quarter our aggressive we our clinical lead to to CAR-T

product back lead to from US I our expect that, candidate, pre-IND we ONCT-XXX, receive in FDA to over XXXX. DAARI With Jim. will call For the December of the feedback turn

Dr. James Breitmeyer

This past or its meet continue to goals. internal Rich. exceed the you, Thank team quarter,

excited clinic. the coming advancing prostate capital enabling phase resources and malignancies banking and hematologic events make and will the towards cancer promising We patients in our that look three phase program you for Ryan rollout continued us inflection exciting phase a clinical to global focused patients you second and Q&A of we our the significant for which have, our a I will of one our medical advance forward program late along one cancer. for cementing With prostate efficiently from especially Thank key have one i continue to is to this our afternoon's joining and updating back n as and we conferences. are to a believe space, look leadership active and opening, upcoming in study in RO forward suffering use to turn we the difference call. we prostate plan toward with We will the during points things with today, pipeline to d program asset value that, quarters, We for cancer for promising portion ONCT-XXX very three studies.

Operator

Company. Please the from first go line of Our and Hartaj Singh instructions] ahead. [Operator Oppenheimer comes from question

Hartaj Singh

Thanks escalation, the it monthly for the of plus the a color imagine little Rich around now expansion, there's everyone questions. updates, for I lymphoma announcement and bit on dose going a with trials, with Great. product, into Jim a ONCT-XXX dose and vein-to-vein that the of just just three and a One, CAR-T basis, B-cell time. threes more sort around couple clinical

the some couple after bones, be that. then follow just And could a of Jim. meat what more Just, just got on I up centers those questions

Dr. James Breitmeyer

Thank you, Hartaj.

a excited and about are yields getting an of process automated the manufacturing Prodigy volunteer T-cell cells. get that hoping excited our have, about, normal lot system we the of we processing called kind eight pretty an bench that process we're are in day people and So for selected I, good that we're top that we've with of found exactly we have very in we

of our as course, we pre-clinical our don't if of if here, getting harvesting would days product and Now, patients, with eight have then cells as but yet we're duplicate from possible. and we, we making short work release have we manufacturing, experience CAR-T

So we'll, And CAR-Ts. enrolling day be for Phase the or study. XX pretty for refused have we somewhere candidates who previously available CD-XX day range either to we'll CAR-T not a vein-to-vein, therapy which be patients is good or the X XX will in failed

Hartaj Singh

CLL, you could product envision, other cancers Yep. our with And very target the zilovertamab potential future? with in No, you What autologous RORX our is going the Jim. CAR-T Jim, that's is great. the well.

Dr. James Breitmeyer

a It's great question.

thought been our there's the think could initial our there And been with another as essential in biology Multiple work and our, some and lymphomas. very as CLL myeloma first additional are is And there, but field another candidate CAR our, AML, T so has possibility. we expressed RO one be highly in much not of CLL aggressive there is CLL. to the the possibility,

few or the some additional there's available. then intend So with RORX and tumor are for lung about tumors, solid we of we cancer into probably expressing And technology options a prostate targets. in really and quite co-treatments the expand CAR addition particularly liquid excited cancer to some

Hartaj Singh

combining Also you're Could and combined lines you that, up of ONCT-XXX BTK good, previously little for in toxicity is do autologous earlier you seeing of a of just is with even kind that which And with then question my RORX with Jim. in you, mentioned inhibition. is good possible modalities. the Thank bit, there that also move and with last is you've a target decrease ibrutinib zilovertamab, therapy? a that that, other foreshadow Great. some

Dr. James Breitmeyer

CAR-T combining, T axis Yeah, RO surface. be the with the one antibody the because combining the CAR on the I might think to could antibody tricky block the the cell it of

a so So, antibody. a do different with you do with could raw could you it binding it one

particular form only an the human has taken there's, have that the done of those also, Not there's ibrutinib an agents expressed interesting interesting therapy. the of that's We on would on CAR-T. but are other have, kinase couple a cells. effect have of But in work there's T tyrosine freezer. in we being note with it some CAR-T T tumor to studies adding ibrutinib through combining cells We've also a effect itself

Hartaj Singh

Jim. you, in queue. the jump Thank Great. I'll back

Dr. James Breitmeyer

Thank up Hartaj. to Always you. you, catch with nice

Operator

Thank you.

Carl of ahead. Our Please next Capital question Northland comes line the Markets. from Byrnes from go

Carl Byrnes

the question and advancing Thanks with your congratulations three on for here. progress candidates

out sponsored Thanks, with to the a your investigator of as I studies? have are I addition do have follow the In that you know those prepared well. comments up made largely any then you control, respect to updates and

Dr. James Breitmeyer

ahead Salim. ISDs. the about with Go

Dr. Salim Yazji

sure. Yes,

S have prostate at patient combination we an resistant U row with we dochy opened D cancer. with just that castration recently So one for C and using IST and, active toil actually, metastatic

far so, we IRB have IRB so don't approval, but have And patients yet. any the actually we

you So It's control. hopefully But soon. we said study. investigative an get this responsive is as of patients our actually out

Carl Byrnes

but thank aid XX, might Great, of on what expectation And lot might on bit into timeline a clinic programs, there's all of a realistic there the program? Thanks just then obviously terms that X in first be you. be and excitement a around a focusing when the

Dr. James Breitmeyer

you, that. with Thank start Carl. I'll

prostate type drugs had beagle COVID yet. And dog so that we're of in experience studies cancer an used for to been And we guiding suddenly is we was where haven't that unavailable. interesting the related toxicology

we breeding was, was then up. didn't and think happened COVID didn't, it think breeders we so during the what stopped that catch And

around the team and now. final studies worked that so getting the are and underway the, has And right toxicology

that intend the we to to some get open to we're meeting as are and have soon as in we the in with the virtual IND back forth so can. pre-IND and And just some, optimistic have, study the then going we're FDA, a quarter, fourth and going

meeting. might So, and mention reactions experts Cancer cancer at of Prostate might, from you prostate Salim, you Foundation we got the the some

Dr. Salim Yazji

Yeah, Jim. absolutely,

synopsis known we the to cancer the So one around of Prostate around met trying well awards to key in to and excitement went that's prostate the we're last was we cancers. Foundation some top we're you and opinion there opinion and as, experts. positive a what well and our very through week from the of also and do know, people what advisors were program do, leader are key trying And, notch through the as actually, meeting Cancer we very who the program known for leaders in where be in

that great. very that's need to at I medical on for So very also candidate. be indication know but status seems Thanks. on be probably that given exciting would priority with it program. the that want comment breakthrough moment, likely that you the It the potential don't urgent would that it review

Operator

you. Thank

ahead. Robert from next of go H.C. comes Our Burns line question the from Wainwright. Please

Robert Burns

as saw XX% in population. patient curious objective in Hey guys, CAR-T we questions and therapy benchmark on color VelosBio's they VLS-XXX my CD-XX sort for the directed thanks CAR-T that around obviously, for congrats DLBCL. in you a was those I guess rate quarter. question, with ONCT-XXX data little second in the receive from taking response that what that CDXX I view did then experience of the whether XXXX just directed dataset? five patients, And

Dr. James Breitmeyer

you So, repeat patients specifically? question? Rob, second Which, the can

Robert Burns

benchmark what for at sense going in response the is to dataset post XXX were just population? Yeah. I'm DLBCL. directed CD-XX CD-XX get was objective Remember DLBCL, They a XX% trying CAR-T patient therapy be the receiving the had there the XXXX those had prior just VLS curious in I patients. rate. CD-XX of patients whether five to CAR-T ASH to

Dr. James Breitmeyer

great Yeah, that's question. a

don't, was updated I it that response right, larger or here while a I'm to the data. get, so I first X closer also you're XX% meeting, if of know, that and in survival once, think but public five I patient overall was it in before. patients low, measured from VS those at they once six outta of that that all ASCO don't the very the rate that treatment, DLBCL both recall memory months And were four were CAR-T, my to we first in been the to and XX% BTK to or the experienced had patients progression CD the do was program set lower, XX% I X think remember and question, survival pass the you months. I data are free X XX stressing answer has when once do your do think I recall presentation

will, what will will that clinical response to exactly with significant a it pay that that that forward will believe the support and going people it, we so be be rate hard EF And a attention be various outcomes. the the of will percentage same because at getting It's doses a efficacy we'll potential exploring is. we're predict time course look a to little at program

Operator

you. Thank

comes of go ahead. the question Storch next Our from Please BTIG. Kenny from line

Kenny Storch

could trial on and this down it'd Thanks guess an drill share love team, to to you running, pacing is there. turn maybe you over terms in taking many internal you sort for Thanks. color on the sense my of, turn, of to Kenny Hey, of terms you trends, sites of up ZILO-XXX Cary. know, enrollment get I you what and trial, how great know, I'd for maybe question. the in clinical I'll early if get for you're be update any know, Salim. to enrollment are of, a seeing

Dr. Salim Yazji

Yeah, Kenny. thank you,

we I operational such think know for not at moment guiding are this a you details.

to As, possible we're then those goal met, everything's open enrollment trying sites to do, and so. get

Kenny Storch

you. it. follow a then, is into is same to in that mostly XXX or that going the XXX so Thanks. that be on separate Got at study, conduct don't just you patients trial the on quick Thank based study it and one the to guess I And screen sites, trial? plan a parallel

Dr. James Breitmeyer

monotherapy initial the to patients Bruin. would actually who XXX a early and thoughts as enrolled in capture this trying for progressor Yeah, so the those says during be the

Operator

to you CEO Thank I answer and of now for Dr. the reached Breitmeyer, and chairman, James and turn and ladies to like over have comments. closing the session, we would President question end the conference

Dr. James Breitmeyer

And interest thank you. look well. you We in your us staying We to and I that, touch in quarter our, for earnings. all And you with in the and with do say will time our on and I hope update joining business for third would everybody Ryan. forward you, interest our Thank thank and appreciate your company like goodbye. today to

Operator

you, now Thank conference you for concluded. The participation. your sir. Thank has

You may now disconnect lines. your

Oncternal Therapeutics (ONCT) 4 Nov 222022 Q3 Earnings call transcript