ONCT - Earnings call transcript Q4 2021 | Oncternal Therapeutics, Inc.

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Operator

Greetings and welcome to Oncternal Therapeutics Inc. Q4 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. to CFO conference of like host, to now Vincent, Richard Oncternal would turn over the your I Therapeutics Inc. sir. ahead, go Please,

Richard Vincent

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

call call section press full will Harbor results, Safe this by XXXX We at next Joining me Dr. and Investor Breitmeyer; full fourth discussed release update today. call Act. quarter our be the and is filed and of are, Q&A. available Litigation on provisions Today's financial Reform President today's that XXXX days. Dr. year Yazji. a and of and James least Securities Salim covered the Relations of afternoon which CMO, includes replay note on followed today's under XX the for Oncternal's CEO, our information Please discussion Today's website the for Private will call earlier be the business a of our XX-K certain year the on our

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

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

James Breitmeyer

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

otherwise designed the kinase-like of relapsed in on we the lymphoma of with important our fourth affinity made biologically Phase consensus design our feedback also Orphan progress pipeline, elements agency positive receptor-tyrosine that potentially treat FDA high ROR-X, or a key with During X entire X. zilovertamab antibody including global of of as with XXXX, with elements study ibrutinib quarter development We the Receptor the humanized program. first-in-class to and refractory significant known we mantle ZILO-XXX, investigational, monoclonal to the reached received zilovertamab, binds our on planned combination from on epitope development key the and cell our in patients zilovertamab with

to in X of quarter study expect second We XXXX. Phase the the initiate

on developments are patients alone. and the all ibrutinib CLL or MCL regulatory this clinical historical with the zilovertamab by ongoing commitment to efficacy data of our data were for X/X with compared ibrutinib positive clinical Our trial study safety plus with and results that to supported from front Phase encouraging

results CMO a in summarize Salim will Our clinical moment. Yazji these exciting

track phenotype the CAR and at potential autologous therapy cell encouraging expression cells, expanded as ONCT-XXX next-generation and with for process progressing manufacturing our off-the-shelf IND for the program. data for lentivirus cell FDA, T Research We We targeting in development Institute discuss T RORX-based pre-IND the collaborations results also is on submission. lead for we clinical The meeting and our Karolinska will productive generation Salim number an IND preclinical plan lead very a GMP plan CAR-T our supportive program. to had cell the lentigen mid-XXXX for generate selected cellularity campaign to therapies. made the very with have our We with candidate. a the of work cell progress development CAR-T is also enabling RORX the planned and continue candidate.

We January, D-A-A-R-I inhibitor very the presented androgen are as also action, or receptor. dual lead induces inhibitor. which action excited ONCT-XXX's degradation also we about detail At Day mechanism R&D our of novel receptor androgen or receptor AR ONCT-XXX, DAARI, about candidate androgen a of our in

ONCT-XXX or binding Virtual Our DAARIs International inducing domain both degradation. patients appear as cancer we or in targets, relevant the inhibition at addressing Conference for ligand NTD such variants needs that treatment-resistant AR be of to highly exerts disease. end amplification, the presented AACR-NCI-EORTC with prostate cancer role AR molecular unmet and LBD including an on AR Preclinical suggest with differentiated, express These domain antitumor prostate models, AR-VX. androgen show believe terminal in the with interact those clinically that and play data they or that ONCT-XXX as enzalutamide-resistant could the important receptor splice advanced activity data

ongoing to XX continue one and CR treatment off CTOS interim for to Ewing investigational patient months patients ONCT-XXX, Meeting. of Two small months. we at treatment evidence oncoproteins, no EXX complete enjoy our including sarcoma durable the Virtual X/X who Finally, had presented of targeted or clinical of responses, continues data XXXX have family after Phase from on molecule a disease the inhibitor ETS several with transformation-specific the study of Annual relapsed/refractory

treated of a explore dosing treatment ONCT-XXX patients new continue sarcoma schedule. currently being We optimizing to an for patients Ewing's ONCT-XXX regimen intensified with the using and with single-agent cohort are enrolling

Dr. Oncternal's CMO, turn me Let Yazji. over Salim to now

Salim Yazji

Thank everyone. Good you, Jim. afternoon

study announced with And response This ibrutinib. either blinded disease provide X placebo them months our may relapsed of ZILO-XXXX randomized after potential ibrutinib or have MCL partial approvals. study four only two recently randomized patients monotherapy. As refractory who or a receiving or Phase were to reminder, a we stable reach zilovertamab plus had receive

plus DOR; and or a response First, an regular duration second, or escalated FDA of as response a or survival progression-free based approval on rate based on approval primary ORR overall PFS input.

ibrutinib open-label progressive monotherapy study label and an disease study patient. two study. or of final approval in of we to the enrolled. early indication. early reach This study and after three the results after approval in for We patient this in is third planning roughly may expect innovative first years as final enrolling our And support are could running single escalated ibrutinib plus as as have and zilovertamab plan companion years XXX of to ZILO-XXX, a an support approval study the during patients randomize the to design ZILO-XXX as endpoint who we conduct initial approval escalated patients PFS both currently endpoint the Additionally,

in now phase. are ramp-up study We the final

the support have and in the to a the operational We execution global study selected second quarter of initiate CRO we expected this to year.

patients months. PFS CR XX% with is ibrutinib or PFS XX.X patients of MCL ongoing data who prior months this zilovertamab in for stage the The of from monotherapy. a lines which with XX% the two overall As plus supported data the compared which as therapy for encouraging which ASH ORR to were historical for for presented of XXXX XX% also an PFS our thorough encouraging to compares and has XX.X and historical ibrutinib historical of trial Jim compares clinical median one combination of be at continues we with very profile zilovertamab landmark mentioned, entering also well-tolerated X/X of or favorably in improved ibrutinib a of with December monotherapy. months XX combination for Meeting at previously with consistent of to ibrutinib respectively. received ibrutinib zilovertamab monotherapy and PFS MCL treated late historical with XX of had Median compared by data monotherapy patients favorably Phase ibrutinib follow-up The XX% clinical around at with a months favorably to are months of the XX.X response ibrutinib. The study very with CLL safety of rate for rate XXX% CLL XX% of

of its documented in patients ibrutinib zilovertamab only study. Grade XX% X.X% lower neutrophil For in registrational X X and patients compared with with decrease ibrutinib example, MCL the from of was to plus

Regarding autologous track the with middle submit candidates of on of we to in the FDA this year. and ONCT-XXX CAR-T are pre-IND targeting productive had we IND RORX meeting our program, our the lead

board We also recently are close cell at advisory selecting established to and the major a centers academic scientific therapy very experienced sites. clinical

now with our financial have therapy. Our Vincent those results proposed patients study call CFO, CAR-T I enroll the including over cell and turn malignancy relapsed first-in-human to or upcoming will review will failed milestones. to refractory Richard hematologic CDXX who our

Richard Vincent

you, Thank Salim.

or researchers to research from NIH. ZILO the Medicine and advance Institute an grant revenue for Regenerative $XX.X the at Medicine Institute of October the National grant Diego is Health and a UC to from CIRM or board of XXXX, School study. California grants San million development two awarded derived In our CIRM grant Our

We conducting in study expires that a to the Diego research quarter $XX.X UC milestones in collaboration of XXXX. San million and award development period awarded two and to with approximately throughout expect activities to In company's supports in for of support receive the million are under up for quarter third the preclinical $X.X the payable and the XXXX, sub-awardees. ONCT-XXX the million including ONCT-XXX $X.X company programs NIH research grants development first

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

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

million quarter the million $XX.X year million. $X.XX $X.X expenses totaled basic loss full for $XX.X administrative research Costs of development a the or and general $X.XX and share per fourth expenses and XXXX, and diluted. for For was totaled

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

and mid-XXXX. of support $XX.X equivalents believe cash December these XX, no to we sufficient into XXXX, operations be had will We million debt. and cash our funds in As

manage carefully to enable all milestones. us of and our continue to will have to sources We will explore expenses and capital reach potential

initiate XXXX. XX, X the we XXXX, upcoming of had study outstanding. of ZILO-XXX Phase of expect As With registrational in to million respect our to stock XX.X global the quarter shares common for program, second zilovertamab we December milestones

with patients plus clinical zilovertamab We for MCL interim from in study and update of data XXXX. expect report ZILO second ibrutinib quarter with treated to our the CLL ongoing an

Xb with in a We patients also expect investigator-sponsored to plus docetaxel initiated zilovertamab cancer trial Phase for metastatic prostate castration-resistant of have mid-XXXX.

On therapy ONCT-XXX, IND autologous candidate our plan we in front, cell for therapy mid-XXXX. the RORX our first to cell spend CAR-T

IND-enabling quarter of second our the manufacturing expect candidate, DAARI For in we GLP ONCT-XXX XXXX. to lead toxicology initiate product and GMP studies

expansion intensified cohort to For the of ONCT-XXX, patients with data we expect fourth report interim quarter sarcoma, in clinical dose for in treated updated Ewing's XXXX. the

Now I Jim. turn the back call over to will

James Breitmeyer

you, Rich. Thank

are X clinic. progress our We toward with our initiation and multiple XXXX, advancing RORX catalysts global also especially pleased DAARI as the our the study zilovertamab IND in of as Phase CAR-T application forward submitting in XXXX, well and the program to look

for strong challenging that, difference today of historically you We for Q&A resources I us sheet help we macro on of and portion for greatest of With this will joining XXXX. focus this the product forward balance high Peter patients. things turn to can updating the unmet we navigate remainder our our need, back look us environment. believe areas to the call. to Thank Our for afternoon's you where will candidates plan make patient

Operator

question-and-answer we session first go time Singh this Instructions] Oppenheimer. Please be with will At ahead. is a Hartaj question conducting you. [Operator from Thank Our

Hartaj Singh

Great. Thank you, Peter.

like of what zilovertamab just questions, what sort I just for thanks of studies these RORX and trials? the the quick with And with could CLL trials, specifically clinical is got couple CAR-T One the couple CAR-T, help ibrutinib? the kind and team a from monotherapy of trials Jim designing for ONCT-XXX look there and Just basket the combo of a you that and follow-ups. learnings those MCL then are And updates.

James Breitmeyer

I'll Thank you, start with question. second the Hartaj.

such offer increased tumor and the that moving may the with to reactivity we're CAR-T capable cells an expected to that CAR-Ts see normal program. with with we're trials sense are and confidence will primarily cross which interact safety RORX we're as targeting to specifically hoping an into a so -- mainly minimal of acceptable adult of clinical And tissues

to we'll RORX numbers over in clinical continuing ask trial. to is that of Salim I'll are for the important shape I your also where about hematologic first turn to is answer general which We large question malignancies. do the that it of Phase XXX the CAR-T. -- RORX to study learn

Salim Yazji

Thanks, Yes. Jim.

the human I escalation to in dose think which to not who first CAR-T specifically in going patient So be do probably we're is planning to mix -- phase, actually we'll try population II we start the Hartaj? this to the once in answer and in therapeutic some where Does dose different we question, is reach dose, that expansion lymphoma. recommended indications. But Phase will

Hartaj Singh

a Yes. that. But clear, might want to lot. That so just be I have helps I missed

will will the include cohorts range patients or broad trial? when the expansion part that a of into You happen the initial you of get CAR-T in

Salim Yazji

-- I Yes, you the plan FDA mix to population is get dose safety CAR-T the was a group. have when wants think to expansion we very have because not to escalation like usually and the specific

James Breitmeyer

an that, do clinical for acceptable Let we is trial me small guess basket that the add I initial think lymphoma population.

Hartaj Singh

that do the if do using -- ibrutinib molecules would get be the in part of any kind the in will Or wait that any also to Great. small of just combining? expansion that going you And you're then, of you to one or when other you trial?

James Breitmeyer

CAR-T we're we'll itself later. a picture sure factors safety with that profile clear augmenting have then the we and of study so initially, additional its alone consider We'll by

Hartaj Singh

the that for high you're to what steps. the for continue in one the Great. more on part looking get I to last The with is Thank order to complete you the would you, see really to just the kind thank got this dose XXX, year responses What we than nice like of for in for looking latter the When and project. sarcoma mean, on go of you XX the order data. gents. next you've And months. Ewing's to And you're all question is, project questions. then hurdle

James Breitmeyer

your Sure, take Hartaj. question as last And I'll -- well. I'll take

be So, at true responders. and to partial that the indication would a is complete we're least looking TKXXX response for an response rate and around XX% that

Hartaj Singh

Great. Thank you, Jim.

Operator

Thank you.

is Please next Capital Northland Our question go Carl ahead. from Byrnes Markets. with

Carl Byrnes

considering How R&D programs initiation ramping on do the spending the that of up progress. are the trials Thanks. other ongoing? obviously, see R&D Great. Thanks XXXX and question, also for ZILO the and congratulations you throughout the

James Breitmeyer

Rich?

Richard Vincent

Sure.

a burn, XXXX So in on our and as debt sufficient our or we do we ended books cash with we equivalents of quarterly provide under to million just for annual decrease fourth our we while no that do into cash about planned current $XX was mentioned, cash not resources million the the are cash $X fund quarter, guidance on mid-XXXX. anticipate operations

Carl Byrnes

Thanks. it. Got

Operator

you. Thank

Please question from Pohlman Kaveri go is BTIG. next ahead. Our with

Kaveri Pohlman

question of binds ligand Thanks end opportunity. zilovertamab Good domain, afternoon. domain domain, for the a ligand the same bind? stable but how the includes at does where absence is CAR-T in binding drug Yeah. ligand terminal for binding the binding first My XXX. is both the LBD lot the site The area and and bind binding the of because

James Breitmeyer

are Kaveri, questions. good this both Jim. Those is

binding that both So binding and of vitro we are the in seeing in in very cancer prostate activity vivo models have lost the satisfying ligand domain.

in-terminal cancer. binding to we believe prostate So do the that, is inhibit sufficient

strains activity domain binding enzalutamide, ligand in the it seeing than On enzalutamide-resistant prostate are cancer. we to appear lines side, or bind because does differently of

Kaveri Pohlman

EGFR-mutated for cell patients. Got there survival RORX? who I that an studies have cancer you see in in shorter been over lung TKI with patients And zilovertamab, have opportunity non-small do shown some express benefit believe it.

James Breitmeyer

Yes. We're And cells some in arena as lung data work RORX. be is that And a noticed inhibiting the cancer that might those is cancer clinical by treatment are right lung resensitized preclinical have now now. osimertinib that we're resistant pursuing become we osimertinib particularly publication doing intriguing a to to well. very suggesting important problem cancer course of result right that in lung

Kaveri Pohlman

And you. on That's breast one the very Yeah. studies. Thank the maybe IST last helpful. cancer

made the cancer, by you on insight provide HR-positive about landscape with can think recent and for ADCs strategy? you treatment or any or TNBC your do changing breast how So development progress HERX-negative

James Breitmeyer

Thank you, Kaveri.

have breast in clinical landscape the cancer, has through been we investigator-sponsored noted complicated. studies. the work So -- that been that's so far that becoming increasingly is work done And

company. for And and fantastic would with that news that's quite a have long trials Now aware it cancer, cancer to small be but complicated patients arena a it duration. for in makes we're breast large also breast

malignancies And cancer, are indications. breast our no we when prostate the stating longer of list so on as are prioritized cancer hematologic you'll that notice emphasizing one in we that that is

Kaveri Pohlman

questions. makes Got Thanks sense. my That it. for taking

James Breitmeyer

Thank the questions. for good you

Operator

you. Thank

is with question Robert Wainwright. next from Our ahead. go H.C. Please Burns

Robert Burns

for Thanks on got taking congrats and may. updates. my I three questions guys. I've Hi, the if

ZILO-XXX ibrutinib So I'm be two your specifically approval say thoughts plus you placebo. to would announced, think versus that between with around arms regard those to of sort ZILO ibrutinib the get Any around accelerated what delta plus to for curious thoughts have

James Breitmeyer

Salim?

Salim Yazji

Yes.

I have mean, say be or So see carefully. anywhere we looked of the can what XX% very it we you very I in into statistician XX% delta. a have this additional we arm. think actually significant statistical And could our control

Robert Burns

ZILO-XXX progression question are about an study that that next And to How for potential on potential study. companion regard movement Obviously, thinking Okay. with into you that's open-label post ibrutinib. space

Salim Yazji

Yes.

do. we So

James Breitmeyer

Go ahead.

Salim Yazji

know unmet be especially you as it have those meaningful patients a actually any you'll could able So rescue if after medical we be and BTK. to there, patient believe response need those on huge population progressing very

Robert Burns

for one XXX. to me Last regard with

be threshold be around potentially know and a you whether I solid clarity solid of might I this middle tumors. with which is what the biomarker planning tumor to going hematological sort of expression submission that you're regard you're you predominantly think So a you trial, Can institute then would doing of in you to could and next assume would malignancies step times year look like? program, IND by and sort you RORX provide a would going some would that when initiate sort cutoff I the but the then to of be Phase

James Breitmeyer

in there questions your three in squeezed you third -- that's Yes question.

as as doesn't have any is a autologous straightforward particularly it tumor enhanced CDXX indications tumors. CAR-T XXX with but will features the that So system. it you to investigate it features But the same would make CAR-T with successful we applicable solid know, solid

we something So to addition that tumor this vanilla is that to the CAR-T solid in -- into the space necessary. believe move is

from at And pluripotent we so in time, additional And are looking alternatives, CAR-T in tumor cell us features adding additional same off-the-shelf such better CAR-NK. looking looking in solid be those features the as to But therapy designed incorporating parallel would beginning the a to stem the XXX environment. we're chance or at we're platform. the the at cell-based that give into at cases

Robert Burns

guys. update those Awesome. Thanks for

James Breitmeyer

All right. Thank you, Robert.

Operator

you. Thank

Kumaraguru is go Our Raja Brookline last from question Markets. Capital ahead. Please with

Shubhendu Sen Roy

Hi. for Kumar. Shubhendu Thanks the calling for I'm update. in

the regards the Do other to AR the can prostate test you ONCT-XXX cancer to the like program non-oncology with cancer. Now positive plan drug AR? to in program? IND-enabling studies, what in more in Also breast addition in or share AR you over also overexpress that indications indications, about

James Breitmeyer

question for and give I'm day. to Thank Yes. busy best he's Kumar. you having a the sure our

Shubhendu Sen Roy

That's Thank right. all you. Yes.

James Breitmeyer

Okay. Thank you.

degeneration androgen So we the a way applicable have are might indications receptor a -- we interesting that that form be it's the called ONCT-XXX the say is Kennedy's rest can disease, the that's to what which do inhibits I program in And non-oncology preclinical very indication that is of aberrations receptor. moving some nicely. of about related along -- in androgen neuromuscular the severe the

development behavior what formulation are up right we to we hope XXX molecule small now for molecule the a see and studies the point program. to start have this gearing of is to identified, successful early a toxicology would We up the just

Shubhendu Sen Roy

it say and to prostate blockades of is the therapies Thank expectation effect in you when is hormone compare decrease side action What the androgen levels cancer? that in useful. on profile you. safety ONCT-XXX That or

James Breitmeyer

have But There's ONCT-XXX that associated excited is not of say toxicities since yet be as androgen a we some be side that about antagonists that this haven't to cross of a drug studies thing barrier. does we and one is many that with that similar would would the our activity seizure to effect. And delighted like were toxicology are been the assumption find done blood-brain theoretical first So a enzalutamide. the would answer. I we

theoretical lower So a having of possibility we a seizure have risk.

Shubhendu Sen Roy

on therapies. speak you wondering could Okay, the for collaboration, that we the great. can And when updates expect cell with finally, I And front? if collaboration the was Karolinska ongoing just on Institutet research

James Breitmeyer

Thank you. well. collaboration going The is

two the a traveling first have are collaborators we're week to our and face-to-face going Sweden looking with we fact, meeting half, from them In having are year -- in Diego it. of to forward and our all way a to San next

cell through very characterization and in done. Karolinska, was is advances the a invited to companies its of Karolinska exciting academic was that together delighted that Oncternal discovered we consortium. therapy, is the so, early lot into to the And course, a And and where cell join that of organizations there natural and was consortium killer were of make collaborate

you the that it an think the to results some year expect as course I IND at on program So, in can over track this point from see preclinical of midyear. XXX is for

Shubhendu Sen Roy

my taking questions. for Thanks Great.

James Breitmeyer

right. All

Operator

for and we Ladies And have session. like to the you. back the Dr. of end remarks. I call turn to reached would closing Thank gentlemen, question-and-answer Breitmeyer the

James Breitmeyer

me let the by excellent your interact close today. appreciate call the Well, and attention. particularly, thanking you the questions We all questioners the time on for with opportunity of and to

of all in about updating thank we again and to look quarter. a I you So, forward you

Operator

you. conference. today's concludes Thank This

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

Oncternal Therapeutics (ONCT) 11 Mar 222021 Q4 Earnings call transcript