ONCT - Earnings call transcript Q2 2022 | Oncternal Therapeutics, Inc.

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Operator

Greetings. Welcome to the Oncternal Therapeutics, Inc.’s Second Quarter 2022 Financial Results Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. the to turn Vincent, host, now CFO. will conference your over Richard I

may You begin.

Richard Vincent

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

President our Breitmeyer; Joining CEO, includes Salim a on the website and this Today’s quarter call are me discussion financial update of call be results, which Yazji. Today’s section for Dr. second our and our call a James business CMO, will XXXX Dr. available afternoon replay XX the and least days. of will be at Oncternal press followed next the of release by Relations and on Q&A. Investor today’s

of Our note Private Act. Reform second that quarter call Securities the XX-Q discussed information is provisions on today’s for the also the Please certain under is Litigation available today. covered XXXX Harbor Safe

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

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

Dr. James Breitmeyer

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

we our including the data a progress Phase second MCL made and sets… at entire study significant patients plus pipeline, XXXX, ASCO an update ibrutinib across with of quarter X/X encouraging of which zilovertamab CLL, During in from

Operator

it Dr. Richard, looks Breitmeyer disconnected… like James

Richard Vincent

Okay, could try you him back?

Operator

One Yeah. moment.

Richard Vincent

Thank you.

Dr. James Breitmeyer

technical problems apologize, I home on phone. experienced everybody. been We’ve our

saying especially survival. mutated population BTK and clinical collaboration interim support with our supply registrational upcoming by ASCO. So ibrutinib into that with ZILO-XXX, This with study company, Phase at I combination an of of the very of showed program. our were pXX is presented their a an robust for with we is trial AbbVie value testing milestone, validates entered clinical which to CLL gracious progression-free global support that encouraged ibrutinib a important further we This donation zilovertamab the monotherapy we Also zilovertamab. agreement and current Pharmacyclics, our X was ibrutinib from challenging inhibitor plus standard-of-care patients in data treat to

candidate month. targeting filing IND to our for track autologous RORX product on Next, an continued ONCT-XXX, is and this CAR-T advance also

manipulation collaborations include Dana-Farber Biotec. partners, with Lentigen strong the Cancer along cell enjoying are our with We Miltenyi which Institute, facility, and core

Institute Karolinska RORX-based research therapies. our data off-the-shelf, our our cell allogeneic collaborations Celularity for continued encouraging to the next-generation generate with On and the

year. expect filing and the our toward we an androgen lead of ONCT-XXX, to to inhibitor receptor interactions DAARI Finally, candidate fourth dual-action with the IND quarter in pre-IND have continued program, FDA or the advance for this

as cancer which receptor prostate significant management androgen for clinically prostate the ligand VX, for activity models, exerts such shown receptor, differentiated the androgen with inhibiting and resistant all has vigilant ONCT-XXX This - in believe terminal prostate patients function of end resistance, cancer. our with including it of ONCT-XXX the and focused treatment treatment needs AR novel both represent that advancement those backdrop or a medical advanced optimistic a interacts AR have inducing anti-tumor data unmet the amplification, its of are we of -clinical degradation. resource relevant pipeline patients with variants, Pre occurred We splice against its execution enzalutamide with and cancer, that cash alternative may be broad expressing binding approach. and as domains

Now turn Salim X Yazji in Oncternal’s detail. Phase to clinical to and more our me the CMO, let plans data call discuss over zilovertamab

Dr. Salim Yazji

Good Jim. you, afternoon. Thank

encouraging XX.X Phase overall zilovertamab of And response meeting As for recently and treated overall rate ibrutinib, which historical of XX% very Median presented the Jim of CR of to CR of XX% mentioned, XX% follow-up also of months months our ongoing historical zilovertamab ibrutinib trial plus favorably ibrutinib response combination XX% median ASCO a patients with patients at June. rate MCL in in of XX.X to the which monotherapy. data favorably from for to for rate MCL monotherapy. PFS compares with PFS and compares for ibrutinib with with months, XX.X we is X/X the rate clinical the the

of of is PFS PFS again the ibrutinib pXX with For historical months and the pXX months. the patients was median landmark XXX% and around XX patients mutation, to which XX plus at and ibrutinib months months, favorably XX.X PFS median XXX% PFS XX landmark zilovertamab XX% historical was with at ibrutinib four which In XX around months, CLL compared favorably of mutated XX% respectively. months, monotherapy to at compares

continue causing prognostic pXX and many negative loss mutation suppression. and/or ibrutinib types monotherapy. data to known zilovertamab cancer, know, well for protein genomic be tumor is the profile slightly As of improved combination historical to The you with or of of in consistent instability factor a well compared with of tolerated loss may safety

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

X up selection site ZILO-XXX, track of this completing and are as study the IRB we we submissions. later to including Phase key currently quarter, activities, on are study In upcoming terms initiate ramp

As a MCL, receiving disease may will receive after relapsed/refractory reminder, had or to blinded two months have or response monotherapy placebo provide who will randomize reach identify them stable zilovertamab of only ibrutinib. and potential study either patients four a ibrutinib with approvals. partial This plus ZILO-XXX

progression-free overall second is PFS, DOR. First, based an response ORR, the of FDA on which response, primary survival approval endpoint. a based escalated approval duration plus of And on rate, regular

run ZILO-XXX, the and study approval ibrutinib -- ibrutinib support progression additional the an result Additionally, we study phase of conduct plus an are could open patients planning progressive in who of of companion indication ZILO-XXX expansion. for have during of the monotherapy zilovertamab to study and label potentially disease

patients our to of CAR-T track submit targeting enroll are Regarding our autologous ONCT-XXX, X financial aggressive RORX patients to to have milestones. program, CAR-T study, IND later this relapsed/refractory cell we therapy. and results to the the including lymphomas, Phase on initial CFO, candidates we turn Rich with who review CDXX Vincent will our plan I over upcoming our month. lead failed In our call

Richard Vincent

you, Thank Salim.

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

$X.X XXXX, company’s quarter the third collaboration quarter activities period, and of perspective San with XXXX. to We development in subawards study award to from and throughout million have UC two a conducted milestones Diego research the NIH revenue development receive substantially up In and of the was million under in to the for in completed ONCT-XXX first preclinical expect the company ONCT-XXX for research $XX.X programs. the which support a awarded grants

Our June XX, ended was for the revenue grant $X.X second XXXX, million. quarter

include Research XXXX, second million or development operating first a totaled total June of ended million, expenses non-cash basic compensation stock $XX $X.X general including flows of for loss sales company quarter proceeds as million per aftermarket June X.X diluted. financing for LLC the Our of Cash use shares expenses of $X.X was the million program loss activities and for our common the Net million. second agent. stock-based million. was Through our administrative net expense. of and share a the XX, XX, XXXX, $XX.X Jefferies totaled expenses sold quarter a $X.XX and $X.X million, from and $X.X

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

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

we global X and patients data clinical update expect XX, fourth plus ZILO-XXX provide shares X/X in CLL As XXXX $XX.X To for to in Phase of in our XXXX, our outstanding. interim had our the milestones, MCL study of summarize ibrutinib zilovertamab stock study and common of of registrational million zilovertamab quarter an we program, upcoming September initiate XXXX. from Phase the June with

ONCT-XXX, to autologous CAR-T XXXX. cell IND therapy our candidate, our plan For submit we RORX lead in August first

James. in that, over candidate, XXXX. interactions expect With pre-IND the quarter to fourth lead we to For our U.S. DAARI the back have product the ONCT-XXX, with turn FDA call I of will

Dr. James Breitmeyer

malignancies and CAR-T historically pipeline Thank clinic. that, for in believe inflection today year as efficiently, that you global our use make portion difference will the as forward advancing back we look X forward initiation updating and the well cancer. Phase toward this of performed to we our over to especially look We planned zilovertamab as things advance value at a our macro you Kyle and RORX quarter, the for you, With turn significant well suffering to this to Q&A prostate the of our IND conferences. call. later has and capital afternoon’s program submitting hematologic joining to from application, focused our challenging us toward continue for Oncternal I DAARI this we environment. and resources patients Thank Rich. also points study plan We events will

Operator

first Our Oppenheimer. Instructions] [Operator proceed Hartaj Please from question. question your you. Thank Singh with is with

Hartaj Singh

and is, the everyone moving to question. all it’s the great One see Thanks the for programs ahead. update

there is ONCT-XXX into pXX a it are on find just secondly, trials, look a patients, can trial got on your they what Phase a cetera. on easy bit run mutated there? little then And CDXX, interim with regulatory put that, thoughts thought we’ve clinical more opening RORX the CLL? XX clinical any your team, pretty, what are I Just authorities and the when on saw would sort I have it are and at pXX enough you is even the on an XXX%. update, you mean, intriguing that you discussions What the data maybe focused eye months dig a trial, CAR-T, mutated patients, some trial will with of patients, like Jim to PFS, X/X in just basket could CLL just could call looking with the you et

If you that just a kind into of you more. little can question. bit dig the Thank for

Dr. James Breitmeyer

Sure, you good Hartaj, for thank and the questions.

second Salim And so one. the the answer can I’ll one. first handle

So XX% CLL strong about gene of abnormalities, We believe represent or mutated for a that of CLL can pleasantly also pXX pXX result the pXX very which registration surprising an that a opportunity chromosome. with strategy. PFS of sequences, of patients believe we portions is for the patients both with do -- include does one a carry mutated deletion these but the of XXX%

most characteristic patients it’s that, be inhibitor typed are treatment. for BTK a so for known And already to challenging

-- is there additional would registration And it potential for we think that strategy. be a we think there an so

pXX. going to be interesting there. the and got headed bench on figure We’re what is try between know to RORX some back to out science We to there’s

to about more the that future. near learn in we So hope

so CAR-T. study our ONCT-XXX the and X question let talk Phase about that’s first your for And Salim

Dr. Salim Yazji

those to going an have Yeah, lymphoma do Thanks, here Hartaj. to escalation Once our is in which to large possibly Yeah. go dose, we’re our MCL. be may dose we aggressive to hematological I indication. X reach into going in recommended two specifically indication we’re is B-cell phase, additional Phase diffuse trying mean, Jim. is into and -- and lymphoma what we expand

Hartaj Singh

behind XXXX bench, pXX and to Jim, can for are the timing, the any manufacturing, talking patients and question. to would a then you any put abnormalities just CAR-T of just the of you the follow-up. your And idea going science kind there? from Thanks. on with go just about, for the mean, on the what’s you quick talk go just sort Great. XXXX, when any kind understand in you of And back regulators? choose terms this just a that just this thoughts maybe Thanks Salim, of RORX study? there sites you’re is limitations event, all I

Dr. James Breitmeyer

get Hartaj. So, I think, can of I those, both

CAR-T the you Is program. asking first side manufacturing -- the we’re so And about were that of right?

Hartaj Singh

Yeah. Yeah. Yeah. And…

Dr. James Breitmeyer

Yeah.

Hartaj Singh

Yeah.

Dr. James Breitmeyer

Okay.

the I’ve -- delightful Dana-Farber, And got processing are decades. at with some people -- who facility are cell involving for a the we we some we’ve -- using actually system the so got they they’ve having collaboration -- And known manufacturing to groundbreaking a with going experience that model. in vast cell be processing therapy think really have cell different we a amount the Prodigy of is that field we’re with

And it’s then back ends we’re our product you Boston within being think logistics very pretty careful for both all so timing cells but of patient’s chain and straightforward. the and we’re reserves then is infusion are frozen working the straightforward wise, now, their are to think with I -- right a And -- supply now. know, be transported the cash as pretty we right to out be to CAR-T going we can get

generate and interested changing year. can study this a talk is about, CLL that new could certainly, will as we’re to hoping something soon in. really, or next pharmaceutical have as And be we some CLL not won’t I that patients year, XX% so strategic the probably for we say science of it. a opening companies that are to indication But some be -- game

Hartaj Singh

Jim. the and all Great. comments. answers Yeah. the you, Thanks Thank for

Dr. James Breitmeyer

you, Hartaj. Thank

Operator

Markets. next Please is Carl Our Capital Byrnes from question with question. Northland your with proceed

Carl Byrnes

Congratulations questions. mutation the were on the progress all My is your thanks question pXX answered. for on and

and couple So in IND have in at for cancer? be expect September-ish the first wondering others. I’ll a any considering for dose data Xb August timeline timeline Phase into then the visibility the And move of to if you ONCT-XXX, also on area? you to Thanks. would patient submission investigator-sponsored UCSD from trial of the I’m prostate the

Dr. James Breitmeyer

study, the don’t control the have So really for data. the rate of of in investigator-sponsored -- or any on -- I’ll availability start the enrollment we over

we as But usually know you let you -- I’ll know much do. comment second Carl, and So I than on I the can’t Salim as -- we do, more question.

Dr. Salim Yazji

-- please Carl, report repeat your please? Yeah. second question, you can

Carl Byrnes

with considering would IND or your be expect? or dose in is the the would be patient would be to going This first be September filed whatever safe Yeah. Thanks. respect is timeframe assume timeframe it to you August, in would expectation ONCT-XXX, to the

Dr. Salim Yazji

of know, going August will we’re submit from it’s days Well, XX you FDA. I mean, on as and end hold probably to period the IND the be

I But going some regard I of beginning the questions hopefully to and to us before So from end be going the before mean, to once IRB that’s year. approval we to get of it’s think it’s may patients we’re have there’s get go. until of this take with light, to patients, FDA, the we the end time, no going are hoping green to be ready our put -- we September, probably all the October. by And

Carl Byrnes

Great. Thank you.

Dr. James Breitmeyer

you, Thank Carl.

Dr. Salim Yazji

Thanks.

Operator

H.C. Our with question. Wainwright. next from Burns your is with question Please Robert proceed

Robert Burns

Hey, questions. my guys. Thanks for taking

Just two if I may.

question, whether CDXX CAR-T. just solid tumors targeted also curious, you’re going to the RORX patients was I received prior your the about hematologic clinical malignancies expression both lung operational tumors So that targeted given cancer. you’re runway, -- my And know and RORX ONCT-XXX that have and lead does for therapy for be second I DAARI who guidance then your pursuing, trials for financial thinking assets? your with stomach solid and into take of account your express

Dr. James Breitmeyer

you the question runway. I’ll we’ll first about have So and Rich to talk the cash answer then

program immunotherapy into are our we tumors. patients extending very interested cellular yes, solid So, in with

CAR-T, very know even liquid well though As tumors. immunosuppressive current have had they a of well, you solid time tumors generation in microenvironment the very overcoming so the hard of work

inhibition we in -- think the or get like, suppression, sorts I at. that, success feel factor something of you’re that need solid things the so are to TGF with tumors, additional those to like do some people checkpoint the are that, people somewhere beta going field And most looking

but would And so likely it that for kind open tumor runway that we to with tech. eyes more technology, some question. on without tumor solid therapy that field. we’re the open to could succeed trial add-on We keeping a think potential of our treat additional basket up would the Rich, CAR-T the be And solid patients’

Richard Vincent

Sure.

does model initial price. and discussed and as both include overall, or it includes for upcoming what our milestones ONCT-XXX we’ve ONCT-XXX today time and the our studies forecast also spend So, this

Robert Burns

Thanks, guys. Awesome.

Dr. James Breitmeyer

I have way. stay that and And going always very and to Rich been thrifty we’re

Robert Burns

good. Sound

good. Sounds

Operator

Brookline Markets. Next Kumar question proceed question. from your is Raja Capital Please with with

Kumar Raja

questions Phase Thanks on and you ONCT-XXX, and do congratulations to expectation dose? my the also in recommended you for can taking think regard progress. the the get terms to are soon your of X dose how With what starting

Dr. James Breitmeyer

Yes. for Kumar, question. thank you the

We’re and of body dose already use kilogram is agreed per going discussions pretty to starting that to could just we few three, that be a can and six cells quickly. the one-times ideal think in recommended XX at to We but there that think maybe able get we pre-IND a start of T we to get levels. we’ll four, with then dose weight a FDA dose dose a

Kumar Raja

you will escalations? single sales Okay. a dose these do have from all run to manufacturing like And

Dr. James Breitmeyer

Yeah.

getting healthy We’re Packs [ph]. Luca donor with

numbers We’re CAR-T of getting have very expression cells with levels. massive high

can so to then able CAR-T make to appear need. to we cells going And make be -- more we’re we

Kumar Raja

and And how for from with this? will they expectations the to supplement Okay. Oncternal ibrutinib, what the there for trials much clinical have in clinical of are regard the kind Pharmacyclics with agreement of involvement

Dr. James Breitmeyer

and helpful advice we’re good -- with and study elements, design a the some here. of ibrutinib we’re working relationship the team. enjoying valuable terms provided it’s having AbbVie some very They -- is in experience have Pharmacyclics So really their clinical with very

any product relationship. have we this the from they make. -- welcome I if clear, we any commercial the rights but think, with their so, to they we have -- modifications And gained assistance And that in we be don’t would to changes make protocol,

Kumar Raja

Okay.

be what of the IND the interactions that? with pre-IND FDA, the would filing you think regard timing with for PNCT-XXX, do Finally, following to

Dr. James Breitmeyer

for take the me, I’ll tox other not, going work. that of for time on and the everybody demand question. Salim, may because to companies uses an you that’s heard Beagle you from for interesting of that believe the this for preclinical species some with up some There’s COVID-related now is -- there it a dogs right thing or to So, dog shortage and the going And this take it’s toxicology preclinical worldwide it supply But the on of studies. have follow. catch

now right finishing And holding so of bit the tox we’re little a in work. pattern timing a of for our

We’re to this point. not next year, confident at an guiding a IND that but date have we’re we’ll

Kumar Raja

Thanks Great. much. so

Dr. James Breitmeyer

All right.

Operator

question-and-answer the will turn the have reached We closing Jim call end of the for Breitmeyer I And session. to now over remarks. CEO,

Dr. James Breitmeyer

thank to everybody the delighted along for good following you questions significant with were So today. joining company. pass be interact pleased those our us We able who to and are progress to such with

And that, everyone. good you to day thank so, and with

Operator

This you lines your disconnect this Thank time. your conference for concludes participation. and today’s at may you

Oncternal Therapeutics (ONCT) 10 Aug 222022 Q2 Earnings call transcript