Earnings call transcript Q4 2022

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Operator

Greetings and welcome to the Oncternal Therapeutics, Inc. Fourth Quarter 2022 Financial Results Conference 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] And as a reminder, this conference is being recorded.

pleasure to my CFO. Richard now is to you, introduce Vincent, It you, Thank Richard.

may You begin.

Richard Vincent

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

President our Breitmeyer, which by Joining CEO, includes Salim full-year the on the XXXX, and this will the call are me Q&A. discussion fourth update of and call Yazji. Today's followed Dr. for our and our James business CMO, results Dr. be afternoon and quarter

on today's Litigation Today's next Relations today's the note harbor press on our call discussed available of and full-year will release Please Private for XX the earlier certain Act. the XXXX safe filed Investor provisions the of of least call is Reform website replay We Oncternal's XX-K covered section for information the Securities that today. be a at days. under

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

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

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

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

James Breitmeyer

study medical and for clinical good needs. Oncternal, our we ZILO-XXX initiation Phase Rich, unmet product In autologous clinical target patients the multiproduct cell ONCT-XXX, company product late B afternoon cell the product cancers with with X/X advanced stage stage and advancing mantle our study in our we Phase into in transitioned pipeline dose a candidates of malignancies. escalation Oncternal CAR and that with T focused everybody. lymphoma X a robust RORX targeting In and initiation Thank XXXX, preclinical are of you, of

androgen and third dual presented were Our become it patients product, and of at alone. activity to December Ibrutinib the validated X we improve later is encouraging to American data IND in rationale clinical encouraging third safety Phase product ONCT-XXX, compare continued X and CLL. clinical our enabling The inhibitor action studies The with in completing Annual to receptor that Hematology year. data with our in historical to MCL efficacy over our Phase Zilovertamab results demonstrate study this favorably further refractory in results relapsed MCL Society Meeting reporting. our and prior expect continue

The XX data of in are treat it's population. with months, with Zilovertamab or and PFS treated and difficult Ibrutinib with mutation landmark a XXp patients encouraging XXX% deletion CLL particularly to at TPXX

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

to over pipeline our turn to Let Salim? of Oncternal's Officer, programs, me now the discuss Yazji status call the Medical Salim Chief

Salim Yazji

now of rollout Thank you, well ZILO-XXX X Jim. Good our afternoon, is underway. Phase Study everyone. The

therapy. first is world, need activate unmet thesis a we that after from the and to relapse patients with that is there supports medical sites line are on around continue We mantle receiving sites high those investigators feedback in the cell our of the lymphoma

MCL response rate in and historical to of X/X treated of trial with an overall meeting ASH in patients plus the reported favorably data our combination presented from with response December. which reporting with the prior continued We at to from rate Phase improve exciting Zilovertamab for of overall XX% monotherapy. compares We Zilovertamab XX% Ibrutinib, Ibrutinib for ibrutinib

The deep XX% XX% beliefs reached for patients of this PFS MCL complete The with strengthening has responses for continued combination. PFS plus with approximately at not populations the Zilovertamab that of MCL needs. With been of high a Ibrutinib unmet area rapid favorably improve XX medical with monotherapy response Ibrutinib. further we for mutation medium to a patient months, can to which historical our months, medium is treated to compared relapsed also four patients a these achieve PFS with rate and refractory in treated landmark TPXX

also subpopulation. from for patients at presented landmark months at to recent and data treated months study which to or with the XX Ibrutinib XXp it and XX.X% XX landmark of PFS update Zanubrutinib monotherapy with favorably CLL demonstrated at ALPINE We deletion compares data showed very for monotherapy CLL PFS The and which difficult XX.X% treat combination, this XX the months for are patients encouraging. XXX% TXX mutation the of

As is and therapeutic are malignancies you decision and aberration including associated treatment in predict those being -- response, know, among of among may and prognostic factor the guiding gene TPXX most in markedly acquired predictive with commonly TPXX cancer, hematological the CLL inadequate strongest mutation the MCL. mutation survival most the decreased

for Zilovertamab tolerated improved of with profile consistent with with and compared to monotherapy. or Ibrutinib data historical the well combination the Ibrutinib be continued The safety

end let X/X by this approval CAR turn Now our malignancies, to T IRB initial and obtained one. me of we first ONCT-XXX, in year, advanced Phase to In XXXX. of our we targeting hematological autologous expect for study data January role the our share

in reminder, results CAR aggressive and a including have that X three dose. recommended select plus trial a those Phase study three be patients T the failed into B escalation account the dose with As both and taken prior lymphoma, will will safety cell be to Phase treatment, X/X ONCT-XXX efficacy

key we dose PK and activity able results. expect dose and on an in additional cohorts, After efficacy, to evaluated escalation, be initial safety to of expansion and antitumor provide exploration be the evidence initial update will the

Finally, feedback from FDA our ONCT-XXX, are dual final to our to we completing in inhibitor, pre-IND receptor enabling novel meeting we we the action glad androgen are from now with received December. the IND And report that respect studies. helpful

to in IND plan resistant study in initiate cancer shortly an Phase escalation the submit dose metastatic and thereafter. mid-XXXX prostate Our patients a X/X is

I will financial now turn the call review and Rich? milestones, our our results over to Rich to Vincent upcoming CFO,

Richard Vincent

Thank you, Salim.

derived Health, currently is of research from revenue grants the Institutes Our from NIH. and development two or National

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

expenses $XX.X for the operating non-cash $X.X were million December 'XX including XX, total million, Our stock in quarter fourth compensation expense. ended based

the totaled million, non-cash in stock fourth the million expense. compensation $XX.X $X.X general including for expenses operating quarter, were research expenses XXXX million. million and development based Total $X.X expenses $X.X full-year administrative and totaled In and

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

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

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

we As million December had equivalents cash and XX, of cash, investments, we and $XX.X in no XXXX, short-term have debt.

of operations be We believe will our these quarter to into XXXX. the first funds sufficient support

continue and enable us driving potential expenses to to of and reach will milestones. carefully, all have to value explore capital we'll We manage sources

an for to our XXXX, XX, ZILO-XXX, respect X we upcoming RORX our December open clinical program, for million autologous we With milestones study Zilovertamab shares ONCT-XXX, Phase of We global have common from DAARI and outstanding. the our to sites As continue submit registrational report X/X XX.X for U.S. outside aggressive we and therapy. to cell patients cell candidate, expect Phase T the in in for XXXX lymphoma our our study initial CAR to with USFDA product plan mid-XXXX. IND clinical B in late data ONCT-XXX, to

that, turn With the call I back over to will Jim.

James Breitmeyer

Rich. Thank you,

data We cancer. to are of XXXX to hematologic novel suffering execution will RORX can CAR T several prostate the study of ONCT-XXX study readout the our rollout inhibitor excited ZILO-XXX, our development difference malignancies and patients Phase and ONCT-XXX. be a initiation in make programs with have continued from that study, the AR X of of clinical our a year initial

our for this will today, things of points. look joining we resources pipeline John our that, updating and afternoon's to I With portion for we towards us year. use efficiently the back significant will call. to and thoughtfully capital throughout continue as and inflection the to you Thank you Q&A We value advanced forward focused turn

Operator

And Please proceed Oppenheimer. you, Thank be a session. Instructions]. question. conducting [Operator with comes question-and-answer your now question first from Singh we our will And with sir. Hartaj of line the

Hartaj Singh

little end quick NHL, where you. potential and read the are that to clinical seeing why behind rationale but like with other year, efficacy then I with a if that Great, the with Zilovertamab ONCT-XXX, kind then after second then potential out I or thank how questions about up by for the do the expect TPXX team. just a Zilovertamab, is on read necessarily of there? show to a questions one translate you and talk in does Jim got in us you. the And the Thank could you in not this Maybe thanks end and autologous what nice trials? out, CLL scientific look exactly into combination have and B Jim of can really we've do year, you at of Salim, just or seek bit Ibrutinib the question of data you're have therapies that. cell And follow and I'll then ONCT-XXX, couple update, what on question you P&L just follow-up a

James Breitmeyer

for And I'll question, Hartaj. one. the take you first Thank the

it's we mechanism is this RORX to TPXX TPXX development the finding, things what and now do don't happens into that gone point, action common those bench between and fun in back there pathway a the bedside dive systems the believe we're that bench yet. of know three of and inhibitors. drug going where our we what to BTK these we've is the from between So At one is and bedside to it really exciting from that

several it We are laboratories in research right performing now. for

well. TPXX need exciting in what's as in medical tumors but that, particularly with prognostically is you just a not important know, variety unmet is malignancies, solid of as wide hematologic And

a for area of clinical So this and open might whole fresh Zilovertamab inhibition. RORX research up

clinical how translate potential into let Salim malignancies? I'll about So the speak could in trials it

Salim Yazji

Yes, thanks, Jim.

patients line acquiring they Jim refractory they said, as the mean CLL. and we I data very mean relapsed multiple more and I with specifically as for be are regards CLL, mutation TPXX to clinical could really in are deletion who XXp through having encouraging and therapy, of of deletion go TPXX XXp So TPXX

that combine are that effect combination going a the as we versus to maybe if So of to see and choice to BTKi actually physician the go we're thinking monotherapy. in with route, the

Hartaj Singh

you with this regulators approval, T is view bar or of in TPXX And a before your speaking, results patients for about answer could specific just the but regulators and with [indiscernible] higher just question type like question approval in year, if just clinical experience this kind mutation, later meaning look what is, TPXX trials can generally one sort this RORX, specific don't Salim, of accelerated we CAR mutations aimed just KOLS, that at therapies potential, that study know as yet? do having potentially or or conversations

Salim Yazji

health to other but that. TXX planning We or or regulator authority FDA the about haven't the do talked specifically to specifically, we're

a I medical I think path. huge that be to very we And are us think giving regulatory that, unmet of that there. able because in advice we believe would actually there's on need how be agency and good will go excited

Hartaj Singh

a if on like at of quick T the of then could the give end update the us look great. just RORX you results broad year, And a can sort Yes, CAR perspective? just what

Salim Yazji

Go Jim. ahead,

James Breitmeyer

ahead. go Salim, fine. that's No,

Salim Yazji

I least No, safety We could our but good end and be expect want we an probably those to of an hints even of therapeutic trial some just XXXX. efficacy that know in starting at we say a would cohort. just in don't yet, early very to give it's like, early maybe are by

many how enroll therapeutic can it and Jim, it please the go by the dose how and year. patients So end also all high of depends, is the ahead. actually is, we how

James Breitmeyer

have No, Hartaj, what Salim, would question. you said And exactly other you I that's said. one had

Hartaj Singh

Yes, thank Jim. you,

be OpEx much a fourth little with your in we in bit was Usually spend heavy. tend were quarter very expecting. to line quarters -- what Just P&L, this Rich,

kind thoughts any of just OpEx us cash four your where run over idea next I Just goes of quarters, you've to an but can us how rate the on trends idea give any roughly? till, as mean, two you given to

Richard Vincent

'XX. the guidance Historically, the prospective burned we And about have million provided we've quarter $X Hartaj, us in a bank will have historically in XXXX. million burned We've million stated, on we the $XX So basis. $XX about third into quarter. in that believe the we quarter as first fourth get not

real up end We've well. ramp-up. got expect as is and IND time, activities program, ONCT-XXX to the we'll program, nearing the So clinic the be by things of XXXX we ZILO-XXX the on with definitely pulling there the hopefully, XXX

ramping as we will definitely up spend be go So sequentially quarter-by-quarter.

Hartaj Singh

thank Thank Rich, all Salim, Great. Jim, you, questions. the you for

Richard Vincent

Hartaj. you, Thank

Operator

question of line Please your next our Markets. Northland from with question. comes with proceed And the Carl Byrnes Capital

Carl Byrnes

for thanks on what to site able the more Great, be or might for of in are I Thanks. then terms for United States site a congratulations the your progress. the was your Europe little you balance of in commentary on of question and outside expectations the activation and XXXX? give if wondering activation U.S. in us the ZILO-XXX

Salim Yazji

Sure.

James Breitmeyer

Go ahead, Salim.

Salim Yazji

would you we U.S. I in contact but actually Russia, mean outside as Yes, also we the to, think I there. of a but are are the And lining have are the and Ukraine big did, what between I seeing, happening number the know, sites think going only that's actually mean in situation to did sites geopolitical direction as right the we as due U.S. situation we of up as not like I fast post-COVID well we as not

Carl Byrnes

thank reasonable of just if that would and what the a terms question PK be progression, in Great, you identify considered, year, for preliminary to expectation follow-up candidate you. of X end the expecting XXX, some Phase all And things data, on maybe efficacy you're thanks. XXX. then At would able be dose recommended when a

Salim Yazji

timepoint are we're we program. and decide said dose. think check to and will going that's So a we be design, the this where dose earlier, evaluate I -- three study, efficacy CAR actually recommended think the plus as three we're efficacy based of I be having need the on we Once to multiple I it's having safety, escalation to Phase X what

see depends see we it mean I and all we So what when it.

fast. I have think can early now that very speculate, a but big happen it's on hope we this to

James Breitmeyer

that more to to thoughtful FDA's X Phase is, way And and well I'll a And hoping Project we're we in to in study Salim recommendations the development comment add that product Phase and aware taken is one carefully. X occur arriving is have to dose. new have very ultimately a about heart Optimus at them that FDA

they've early expect to here. communicative be I offered So would that more data with and

are thinking building programs, we Project XXX. so And of early the of both in stage kind into XXX both and our Optimus

Operator

your with Cantor And Li Fitzgerald. our next comes question from Please proceed of with the line Watsek question.

Unidentified Analyst

taking Thank Rosemary for for is you on much this Hi, Li. so our questions.

how so firstly CLL about the initial bit Just able could you with and little the you. you next two ZILO quickly data? then are program? design for mutations, thinking Phase for you to about me, be your talk and XXX, X TPXX And with might trial this a potential generate Thank second how for

James Breitmeyer

Thanks, Rosemary.

up bit. broke little Your first it? question you a repeat Could

Unidentified Analyst

about for program? and next are this TPXX ZILO Sorry, CLL so for how steps with you thinking mutations,

James Breitmeyer

Go ahead, Salim.

Salim Yazji

I multiple so XXp goes the into Yes, medical factor hard higher all and of deletion of the patients you of very to much patients unmet may we treat evaluating optimal. for know, TPXX are with they potential think not line is percentage for the and and aspects mutation it's that specifically. And have as patients prognostic become therapy, CLL get those as need to

the if we second monotherapy choice BTKi to would do combination was choice with So BTKi's second we versus the of a one this, or in like this a physician of the like do would physician to either of generation in arm.

James Breitmeyer

trial And the design. XXX

Salim Yazji

which XXX dose will if escalate Yes, get using no us safety concern. design, and the there's basic faster to trial we're design actually

us doses And the Phase said, as So would actually FDA now Phase cohort actually possible. line expanding into recommended look the we're in as be as Jim them X that hoping the of one we Project therapeutic dose a into or into that into with then get to choosing two are is go dose to X. to Optimus the and that promoting soon

Unidentified Analyst

Thank you.

Salim Yazji

You're welcome.

Operator

time this James closing to There over are no to turn the would further for floor at like comments. I back questions Breitmeyer and any

James Breitmeyer

your Oncternal's staying Good call. forward night. evening touch Thank earnings you. today you for us with for very Enjoy we look and joining in much to

Operator

today's conference. concludes This

You have at lines day. and this a for Thank you may great participation your time. disconnect your

Oncternal Therapeutics (ONCT) 9 Mar 232022 Q4 Earnings call transcript