Earnings call transcript Q2 2023

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Operator

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

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

begin. You may

Richard Vincent

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

Joining call CMO, earlier on and XX, Dr. Today's me XXXX the includes discussion James and our call that quarter Breitmeyer, CEO, of President financial our and ended business results today. our the Dr. second Yazji. this Salim update afternoon June are filed were

at a available of today's and the release information replay the for on Oncternal's Act. the of Investor press call certain be Harbor Securities of Safe days. Today's will call XX Litigation section the Relations website that under Please Reform least next today's provisions Private is note covered on discussed

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

Our actual business. these and our from with or results uncertainties associated to stated materially statements due forward-looking could risks differ implied by those

be XX-Q should previously Form statements and contained XX, December XX-K SEC and full release conjunction our today's in the and cautionary forward-looking These statements are qualified in including filings, ended year our filed press with today Form by considered for filed XXXX.

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

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

James Breitmeyer

now for At clinical significant everyone. medical patients advancing two cancers programs, Thank you, stage Rich and afternoon needs. Oncternal, unmet with targeting we good are

advanced FDA that announced with X/X the Phase ONCT-XXX cancer. US escalation for week, may Last the for we study received patients of prostate Letter dose Study from Proceed a Oncternal

activities study period, data are schedule. With XX-day third and application initiate initial review that, XXXX. completed FDA's quarter tracking standard to our the we readout first of before of was and our in half the expect startup expect review the IND the of study ahead in our clinical

are to patients prostate ONCT-XXX soon. advanced cancer We to excited suffering very bring from

preclinical the common ONCT-XXX suggest reminder, androgen drive that receptor that study most AR such or results to tumor currently active against as our ZYTIGA. aberrations is a As signaling inhibitors XTANDI approved resistance

Yazji Salim study provide CMO, design in details plans will the up Our and about more a moment. ramp

CAR meeting and With patients that respect to T or autologous is report to first our very our that RORX the enrollment expectations. surpassing dosed are been now targeting pleased we ONCT-XXX, have

be Zilovertamab, builds We Phase X a was targeting CAR believe clinical ONCT-XXX may and T best-in-class which experience extensive our with safe be in it to RORX studies. found CAR several X on as

cells against expressing from our process models of Preclinical tumor specific to-date runs activity support CAR Clinical is cytotoxic robust ONCT-XXX scalable, RORX manufacturing reproducible, and multiple therapies. approved shorter thesis T than completed that manufacturing and several robust, to types. continue show our

initial We XXXX clinical readouts data data XXXX. late to announce additional with to in some expect continue clinical in

and Oncternal's for with to expand Yazji, over CMO, plans now on call me Let Salim our our the Salim? clinical ONCT-XXX turn to ONCT-XXX. progress

Salim Yazji

Good Thank you, everyone. Jim. afternoon,

active. announced As is IND ONCT-XXX our now Jim that mentioned, for we

possible. We fast working bring to diligently as ONCT-XXX to are patients on as

androgen prostate relapsed enzalutamide abiraterone. including to a escalation metastatic is or disease cancer next-generation are will with ONCT-XXX-XXX refractory enroll receptor with have that castration-resistant inhibitor, Study signaling Phase patients X/X progressive dose study that or

levels. Simon a to to an will the efficacy at roll tolerated the two will X-Stage or quickly ONCT-XXX and escalation identified, dose dose statistical evaluate or which design, design maximum identify study dose MTD safety method of and use X Phase optimally is MTD. Once effective The beyond optimal into interval baseline the the is the

we the in significant patients the and US have need clinical ONCT-XXX study. And ramp The And to metastatic KOLs address clinical support dose well with to portion that Europe. a will sites working up of of the are already we to to potential unmet initial of is investigation candidate. selected relapsed/refractory prostate The for underway. excited study them be finding cancer novel institution and appreciated with by been the product advance has top the our start academic

in initial to progress, initiate on we data to half and report in Based third XXXX. quarter this the now the expect expect the XXXX of first study of

those our We B-cell first into previous aggressive have CD-XX recently including T Phase gears our study lymphoma, T. switching who with the treated RORX therapy. ONCT-XXX-XXX, Now, CAR study, relapsed/refractory patient in failed CAR patients targeting X/X for

As a reminder, responding a extreme patients and survival little progression-free to their with survival. median need short treatment medical unmet who next overall of have have failed very CD-XX and treatment likelihood

Overall, we by are enrollment with pleased look rate end data this to year. the of pulmonary of very forward and the discussing

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

Richard Vincent

Salim. you, Thank

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

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

Our resulting initiative quarter approximately Xrd, decrease $X.X total represents quarter XXXX. of first an the second we were including for total $XX.X efficient on April million announced million of operating million, million cash expense. non-cash for $X.X down in from expenses our represents That compensation $X.X operating the from our a stock-based XXXX. the that wind reprioritization expenses activities That of

income general Research and expenses $X.X and administrative totaled was million Interest million. expenses and quarter the for million. $X.X totaled development $X.X

of per the loss and $X or basic loss $X.XX dilutive. quarter second share Net for was a million

be these shares XX, fund of million approximately funds no XXXX, million XXXX, cash and into sufficient our common in stock had June As to We and investments XX.X XX.X outstanding, operations will we of debt. believe

we on With milestones, upcoming track. respect remain to

data T, readouts autologous end data to by the with we XXXX CAR additional For RORX of report XXXX. ONCT-XXX, initial expect our in clinical

candidate, to in the initial For ONCT-XXX, data half ahead we clinical XXXX. first in and schedule DAARI third our to of our product late X/X Phase study quarter initiate expect of the XXXX, now present

Jim. over call to back I will Now, turn the

James Breitmeyer

Rich. you, Thank

the our two retaining pleased for catalysts while significant as programs, XXXX. cash execute to into runway with lead very are to achieve recent our our continue clinical we plan progress We on

afternoon's that, I for With turn of to portion call. this Q&A back will things John the

Operator

sir. you Thank

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

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

Carl Byrnes

XX question -- the PSA study? do for with, congratulations progress. respect then signal see considering mean, this obviously in Thanks incident the days? ELTs determine question. MTDs I reduction I the so XXX, timeframe the of And a have or will on the the potential X a using the for think, determined will of and incidence it of you With early to Phase is I a follow-on be portion

James Breitmeyer

of are signal would designed were And patients and -- think eligibility we remained do enrich criteria biomarker. include Karl, action androgen-dependent PSA androgen -- So, an PSA the as is yes, possible. the we a to for inhibiting dependent early disease that receptor mechanism whose

Carl Byrnes

X close Excellent. study initial signal consistent early Phase And XXX the similarly, data? CAR you with if of with T and is recommended to, there do for in therapeutics, that in potential not, other a considering efficacy the dosing dosing see

James Breitmeyer

do take that you want Salim, one? to

Salim Yazji

forward -- to signal Yes. we I as CAR also like to those duration sure. would know, T, early expect will -- especially failing very to. CD-XX signal see looking Yes, CD-XX we a well. very to early actually like something are I after are failing have and response mean, patients you think and kind we as after treat hard would be prior to have mean, I of would we that of an an expect actually

Carl Byrnes

Great. Thanks. Congratulations again.

Salim Yazji

you. Thank

James Breitmeyer

you. Thank

Operator

And Hartaj question. your question from of & next Oppenheimer comes line Please the the Company. with Singh proceed with

Hartaj Singh

MCL I of a the Thanks for NHL and Zilovertamab, indicating all I Thank good and on various On couple your on -- believe, look there. got following XXX on got question. you've guess, good with LBCL. types updates Great. If patients in B and questions. patients showed previous I clinicaltrials.gov, is of a just then you're you. I really One signal cell the expansion, already MCL. MCL LBCL pretty

previous the your seeing? mean, be then kind you're close would I after escalation through like? dose starting this. look MCL dose what imagine on I building patients And to just a Phase X you got just those off, question recommended be I would walk us So, just can And follow-up of question,

James Breitmeyer

Salim?

Salim Yazji

Yes.

So, all are the escalation, Hartaj, mean, the dose escalation. to I in dose think the accepting in I we we're lymphoma trying do, what aggressive actually beginning, when

would the separate have in MCL, lymphoma aggressive expansion, type. other think and like to DLBCL like However, I we

MCL As of now, DLBCL. two the indications, and we're only is which going with

-- what other the was Hartaj? So, question

Hartaj Singh

higher And kinds expect something that, to CAR with previously, dose, a terms just going a follow-up is mean I Salim, CRS of we what DLTs, since other analogous Yes. to a which we've that of should this Ts seen with in you're and just is just of CAR at toxicity? your Zilovertamab knowledge and -- in T

Salim Yazji

ahead. go yes, -- Well,

James Breitmeyer

Salim. that take can I

not the there's efficacy know, So, robustly patient the the and are kinds Hartaj, curve cells most not with tumor. dose a target in in a distinct there's quality how they there CAR expand CAR ultimate to programs, as of as the sure response molecular of -- -- the you with and of entities the T because do as other T has I'm

But that that -- if for cytokine our type us T is doing want tell your have you the some construct We that example. to CRS be what T doing to. investigators is would it syndrome, of you to some CAR release we're see need process and one expected CAR see

Hartaj Singh

data that sense. -- makes the of Yes. Jim. or of That year, potentially? I sense, kind a also the data see then end -- efficacy be would potential of clinical just makes some mean, the update Really safety we'd makes a And lot

James Breitmeyer

Salim?

Salim Yazji

Yes.

of see some So, Hartaj, by we the end yes. year, would expect data including efficacy even pulmonary to data the

Hartaj Singh

the questions. Great. all Thank for you. Thanks

James Breitmeyer

you. Thank

Operator

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

Rosemary Li

so our on This there. for Rosemary taking is Thanks questions. for much Li. Hi

about could you and landscape Just think how fit in XXX, you cancer about eventually treatment one the a first a talk XXX bit can change in in? prostate general

James Breitmeyer

Happy you to in today. Rosemary, for and thank standing

enzalutamide, virtually standard-of-care the landscape the sitting are disease. the has that believe we medical The darolutamide, part of every unmet in metastatic need. is receptor patient androgen very inhibitors, portion and early that and abiraterone So, one core significant we're for of signaling therapy apalutamide, where treating

some that resistant to independent agents, signaling those And androgen that's very standard but and patients to at proportion the large them a inhibitors. AR who androgen dependent, time become not resistant receptor receptor targeting, them but remain of we're of become

more and which And toxicity. much so population, in a or between chemotherapy therapies it's radiotherapy, have large that's hormone that and space

with. think there begin So, to fits we it perfectly

However, we're strong models and rodent with interestingly, -- very unmutated have very animals activity the also receptor robust were XXX castrated. patients a also native who where androgen or have showing activity in has not

And type of forward move to the that into is normal suggest once an testosterone presence there cancer. late-stage so we've clear advanced in of earlier-stage shown in levels pathway that activity disease, activity that unusually a that strong is prostate

Rosemary Li

XXX. on one Thank was just That helpful. it. Got you. quick Great. And really maybe one

So, have but--? you -- how it's could your data be presented soon really be patients for maybe I an you patient by to do update? after estimation know many in, going first

James Breitmeyer

Salim?

Salim Yazji

Yes.

going the you're present So, the to by that Is we're year. what about? it end when of you talking talk about

James Breitmeyer

Yes, how XXX many patients?

Salim Yazji

Yes.

be So, least different at time to would patients probably with follow-up. three a

Rosemary Li

you so much. Thank Great.

James Breitmeyer

you, Thank Rosemary.

Operator

from with proceed of line And Kemp question. the your comes the question Dolliver Markets. with Capital Please next Brookline

Kemp Dolliver

Hi, thank you.

be are to XXX. you quickly come after you're saying the that but sure therapy, in Jim, with -- Just I chemotherapy? would first-line understand landscape between this before -- thinking

James Breitmeyer

Exactly, Kemp.

Kemp Dolliver

Okay.

James Breitmeyer

still say, Now, after as you agent as some -- regimen that are metastatic would this there suitable the disease, people for first but enzalutamide as treatment plus using, are well. docetaxel know, be

Kemp Dolliver

out? this target patient into And do would that of percentage population the it. what you Got set fall you've think

James Breitmeyer

we're Well, two-thirds enzalutamide trial. remain that or dependent. that's androgen learn after something between that abiraterone And going failing the somewhere clinical in that do receptor and -- we of patients think we're to one-third the

Kemp Dolliver

Got it. Thank you.

Operator

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

James Breitmeyer

both thank and active you, discussions. excellent data both the two of John, well which which We and listened and near-term. who for programs are now and moving in have of you, Thank questions will have the everybody, clinical

will be The entire to refractory advanced advanced And to patients is unmet cancer. and therapy refractory and team excited and addressing with with need. hopefully, their aggressive potential medical high lymphoma to prostate patients be new we bringing

us forward With you look today, banking we thank medical upcoming joining updating conferences. and during for and you that, to

Operator

Ladies conclude that and gentlemen, today's does teleconference.

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

Oncternal Therapeutics (ONCT) 10 Aug 232023 Q2 Earnings call transcript