ONCT - Earnings call transcript Q1 2020 | Oncternal Therapeutics, Inc.

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Operator

Greetings, and welcome to the Oncternal Therapeutics Incorporated First Quarter 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] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mr. Officer. Financial Chief Vincent, Rich Please go Mr. ahead, Vincent.

Richard Vincent

conference Thank joining us. operator. business and financial Good you afternoon, for you update results quarter first thank and XXXX I'd our everyone to you, call. like welcome to

Q&A. Joining be Dr. and and Dr. note President available are XXXX Please CEO, discussion Today's Hsu. quarter the followed call me which Medical business James first website. Officer, of Relations press update call and on today's Chief afternoon release our the this on our by section Frank Breitmeyer; will includes Oncternal's results, of that a our is Investor

website Earlier filed next XX at we will quarter earnings least the first days. call XXXX. our A be available today, investors for XX-Q of the today's our the replay on for of section

Harbor that today on certain the discussed covered under Reform provisions information the note Act. the of is Please call Private Litigation Securities Safe

during business and events making future this forward-looking about will and financial future product We and operating performance. statements be call our development as such strategies

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

press filings the the of events the These obligation call. live after this reflect date of date be are and by occurring conjunction broadcast, in XXXX. as statements only March considered or revise this to no the accurate XX, update cautionary ended We quarter including call circumstances SEC release today's conference time-sensitive XX, is undertake that any information statements conference or with forward-looking of qualified our contains to May forward-looking our Form contained for and in should statements XX-Q This XXXX.

my CEO, introduce our Jim it's Breitmeyer. that, to pleasure With

Jim Breitmeyer

unmet And Oncternal, treatments needs. committed afternoon, medical good developing critical cancer with we Thank novel are who At have Rich. you, for patients to everyone.

a several with cancer product are target We robust that such clinical product pipeline preclinical candidates and indications. advancing

and/or Our focus implicated in genesis cancer pathways efforts development biological progression. on untapped

all trial cancer the on the studying product or cancer breast or we steady well Ewing of includes we've and for indications cirmtuzumab our quarter TKXXX XXXX, first four the Chronic are Mantle clinical CLL. of studying studying made as as Lymphocytic trial progress MCL, for this Leukemia and Cell Lymphoma In clinical and clinical sarcoma, with the candidates

XX% We enthusiastic patients a Ewing we sarcoma response TKXXX. recently rate are particularly ibrutinib, of about and with with the patients reported rate reported the complete response cirmtuzumab treated with for XX.X% recently and combination with for MCL, we treated relapsed/refractory

programs protecting the I its about this and the thinking that report during public on related sites of compliance pandemic. the ensuring Oncternal's move emergency the a safety challenges of forward and effect regulatory data clinical of and of employees wonderful our that can trials, at biotechnology the our is continue managing safety has COVID-XX job the on to unprecedented Oncternal's this clinical patients along priority health the Everybody and with own to doing point industry. at And staff our first been while integrity. are employees,

have at and we study highlighting clinical our into WuXi cirmtuzumab and the have We other XXXX. trial of excitement [ph] TKXXX study the responses but have in patients among the clinical manufacture that the recent back is full sarcoma China patients additional into operations. engendered TKXXX has investigators least our last Ewing by slowed the adequate we reported of drug to our weeks, continued new most of as developers, antibody to constraints, through COVID-XX-related supplies few enroll patient deep despite Enrollment relapsed/refractory believe end to community. in material

in our partial many collaborators the are of Preclinical academic of studies TKXXX are cirmtuzumab but and of lockdown. continuing, laboratories

disclosed clinical on shortly. expect some delays remains will track to new for our report you and milestones indications. potential concerning Overall, So I'm data that happy previously XXXX Oncternal for in we do review results to I preclinical them meet

now will Medical provide more who Frank Officer, programs. Dr. detail Chief will our on Hsu, over call the I to turn the clinical

Frank Hsu

Thank you looking progress the you, and our through in-depth the programs you a clinical product more few Jim. on taking next of minutes at spend candidates. updating I'll diverse

relatively In clinical update oncoproteins. family a small we specifically XXXX, is the inhibitor difficult X novel patients rare TKXXX, treat Phase for been April we've malignancies. sarcoma, to with this is which in announced clinical and multi-center of investigational ETS, interim trial, a agent an molecule ongoing transformation, targets which relapsed/refractory that of data effect EXX really investigating Ewing In the our a

patients RPTD the XXXX, three XX.X% and for disease of patients. a meter day disease the with responses. for toxicity patients, XX treated the cut-off dose without or data which in achieved response, additional TKXXX, Phase evaluated Patients had progressive seven with the had replace date first patients being March trial the of and at cycle protocol is partial X and [ph] of treatment square had stable per evaluable exited recommended were clinical early days been As vincristine. XXX new per had of before seven two or Two have the for XX, or per efficacy Two will rapidly regressed two we milligrams disease.

patients on doing PR responding treatment Both and remain well. are

metastatic complete plus so TKXXX then lesion one. was surgical lung the singulation on PR TKXXX regression of a except removed maintaining patient One vincristine, complete remission. these the sustained lesions residual last a After all achieved receiving lung had a surgically and TKXXX patients of and

TKXXX manageable. lesions patient of of non-target in have safety cycles lesions The Overall, target second of a reduction achieved resolution combination been associated with vincristine. responding and TKXXX following two XX% events with

as For to instance, have neutropenia G-CSF. events, responded quickly such related

In over enrolled the X/X XXXX, RORX combination going interim a which our data March our discussion announced an monoclonal clinical mantle is program. with to ongoing update relapsed/refractory for cell clinical the antibody, cirmtuzumab, trial. patients switch cirmtuzumab ibrutinib in lymphoma we in targeted in Phase to Now I'm with

Cheson criteria. The by twelve response six XX% of new data indicated complete patients achieved or that evaluable a

by response MCL rate observed. metabolic PR BTK or and was response, six XX% compare inhibitors well believe the best results outcomes from populations. these a other ibrutinib of had reported PET determined or similar objective of Overall We One CR response, to a as complete scan.

at the portion XX enrolled group XXXX. expansion study CLL were study ongoing second therapy the the it\s reach of to continues half that patients. all will escalation clinical portions enroll into same of expected patients the patients and actually this and Now of and dose year by the time, treat one in of active our

this update to trial CLL MCL planning data meeting. an are We at from the medical upcoming both and

which of HERX-negative the breast study CIRM of Now additional patients expect an we be clinical to Taxol IST Clinical second in February our cell data program cancer And XXXX Symposium. X final the is with RORX investigator of the regarding ASCO-SITC RORX breast Phase the from sponsored XXXX. presented half cancer, study, CAR-T at available Immuno-Oncology is data preclinical plus in we CAR-T development therapy. In

of is in from RORX as anti-tumor animal Regenerative This CAR-T Diego our or UC, under cell California for model Institute conducted persistence human therapy Diego leukemia. University research activity an the collaborators San grant San CIRM. and by at known the being demonstrated Medicine, expansion, of California, otherwise

to in to been human the through China, The our has in Now timing this XXXX. of program continues a in with is Shanghai study pandemic and initiate COVID-XX events now due goal partnership delayed Pharma. first it work

studies. active has the run to able a and our challenge clinical Oncternal trials performing to been Finally clinical during be COVID-XX pandemic. been remain has fortunate

slower and their continued worked and investigators our at We sites new continued although to our have visits treatment to enroll pace have with of a when patients patients possible. maximize and existing

These help we our And to have been In have to in develop dedicated directly tremendous studies help IV reduce administer closer treat to very our addition, us patients medications and travel. sites patients network our home. and to we to to whom with trials. self-administered continue combined patients worked are a efforts the we drugs investigators to broader allowed to sub-investigator have thankful, and provide working for of

Chief -- over review to back Officer to like I'd results. Financial our Now turn Richard Vincent, to financial our over it

Richard Vincent

you, for cirmtuzumab In to the Phase San patients at XXXX, including UC $XX.X Thank of evaluating the with grant Medicine CLL. of MCL B-cell clinical awarded the School B-Cell trial October advance lymphoid and in CIRM to combination X/X treatment Diego researchers malignancies, our with ibrutinib Frank. an million

in development March ended XX, In $XX with sub-awards study grant receive period. this conjunction revenue collaboration UC quarter with to Diego in award expect conducting was on XXXX. the our throughout award, research and first are this a million milestones the We $X.X San for million

for Our total per expenses XXXX development operating March XX, was the ended share $X.X loss totaled and loss diluted. for administrative the $X.XX expenses general Research million. $X.X quarter of quarter $X.X or a fourth Net were million. and and expenses and basic totaled million million $X.X

XXXX. sufficient operations of these $XX and to cash funds into our fourth XX, quarter the of cash be fund had XXXX, in As we million equivalents. believe We March will

had XX, March XX.X outstanding. common stock of As XXXX, shares we million approximately of

CEO, the Now, call Breitmeyer. Jim our I will turn to back

Jim Breitmeyer

summary. you, like Thank summary clinical to financial of our the for I next the expect that Rich the would that reach for and we Despite same that milestones now this to upcoming over data TKXXX results highlight several for the cirmtuzumab we key to clinical for disruptions COVID-XX pandemic, planned months. on related track achieve to we remain the year. and the readouts had Frank

relapsed/refractory from the Ewing XXXX. data expansion treated cohort to in second with have vincristine the of study XX with seven TKXXX present half plus expect in patients sarcoma we Specifically, of who to clinical the been

the plus treated ibrutinib, for and finding from including We expansion in clinical of Phase dose data patients patients with expect data the update to X/X XX present in mid-XXXX. a study MCL cirmtuzumab cohorts with

treated present We study cohort XX Phase to patients of XX ibrutinib, update including follow-up and the clinical months CLL a finding with expansion for of dose data with for up plus in patients mid-XXXX. in expect to cirmtuzumab the X/X

available cancer a second Xb of in the be Phase XXXX. cirmtuzumab with to study clinical patients data of HERX-negative paclitaxel plus expect breast update the We half investigator-sponsored in from

to half Limited. in Pharma in Shanghai We with patient the the treat first collaboration first RORX-targeted of CAR-T with expect XXXX

financial well-defined ahead of patients XXXX We a multiple remainder closing, a of priority and potential catalysts with our updating product with cancer. work XXXX. in benefit during clinical the look have In advance and our of resources indications in we you candidates to clear deploying to us to multiple operating forward plan

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

Operator

First Singh, Thank go sir. Instructions] you. Hartaj question [Operator is Oppenheimer. ahead, from Please

Hartaj Singh

heinous question, you're the that everyone, on Great, and work thank for that's great Jim, to my pretty continuing you in this pandemic. with

for thank So that. you

for to thanks very are milestones, of the nine couple there. of lot and a the -- next I months. questions a flow clear in those think There data upcoming is Just six

and trials would XD just My is which present one follow-up in question of to if interaction, key And trial on maybe and accelerate CLL that then so go you I of interactions the be you to to that? could through these sort cirmtuzumab would of and data, three the Once TKXXX. this ideal the regulatory would would walk are what that then the any that And be expect after just regulatory specifically a clinical trial in in a expect quick question sort you you second of range follow-up. you a got XXXX? next sort into in of then, approval, of MCL,

Jim Breitmeyer

compound That's question. a you, Thank quite Hartaj.

start and this out to I'll Frank. it I'll turn and So -- over out then Jim. is start

standard So is FDA, evidence sarcoma -- that landscape believed from as responses go with let's second program believed standard a Ewing relatively always because front a sarcoma dismal start that discuss always TKXXX line of regulatory TKXXX the with to we would for number no be regimen single only in perspective, a the line. combination of for of the have with care Ewing sufficient patients objective small -- and treatment we've and so

we the you with So with out had having a Ewing that seven by pathway in two data, little for talk believe the Phase to would responses go rate sarcoma. clinical more a to objective first would imagine, an patients encouraged be can we ready based X we about approval accelerated of be the And to regimen. on are that as FDA bit response substantial and TKXXX

that we than ibrutinib appears In to a ibrutinib cirmtuzumab events interesting particularly ibrutinib other believe to rate an compared plus a considering combinations XX% presented combination the recently. that to Mantle alone, fewer adverse safety be Cell that been have notable -- with -- of is Lymphoma, have profile complete response

Lymphoma that about to we Cell are discussion Mantle quite a close FDA So think to approval. with the enough we having potential have accelerated a information in

see needed seen we to and more the if time data that you've discussed to for For a the far about endpoint to CLL we to today, bit the would so go FDA think with that talk we a progression-free little data a response survival complete we endpoint. mature or that

update. data more our next And so we'll know that after about

let step. and look discuss to him With it registration for you me next Ewing that and Frank might as potential a sarcoma let studies MCL over turn Hsu with what like

Frank Hsu

Thank you, best much within our in is our about very proceed. This at something which discussion is Jim. how -- to obviously group

we both that As cell some we've data some CIRM, have Jim which mantle exciting activity. been we exciting program the shows day and now, have we pointed have TKXXX, Right with with mentioned, highlighting. out, has in particularly as TKXXX that Jim

potential with been to would which could We like negotiations that as FDA alluded on and all registration hope But expand FDA might, that be accelerated program. an that's course. of then to to we negotiated be discuss pathways something, within

is mantle the program program. main cell other The

data. hold very we mentioned, a on results, active that our Jim believe we right when patients hope indicate small have although combination now As and historical of compared a they which group to up, that

trial in several in set one very for, much up could accelerated have negotiations but the that to something an FDA, something are we paths with an there is have ongoing which is discussion the imagine that which very, FDA. And being with which

So comment on that there I guidance on nothing where is about until get could that. we further

Hartaj Singh

Great, thank And actually very the that's Thanks very, commentary. helpful. you. for

indicated got drug The looks you've enough other that the of through year. that like the rest is material get drug to question have I you've supply,

the You've you end cash hand, on of got through the how year, are thinking?

if, thank those after up middle in part data or into especially trial. of low, all cirmtuzumab with say mean an you be probabilities or the to the this kind let's thinking are of on regulatory sort MCL I know from to go manufacturing present you the sort discussions, a But heat for approval, sarcoma, depends perspective get of Ewing historically, accelerated either And financial ready for questions. cash TKXXX data. all again, I your and tend and you how to but just are how about for and XXXX?

Jim Breitmeyer

with potential for question program. track strategy Hartaj, fast really a this Jim. Thank is that clinical you around manufacturing

place So do to have we we plans in to reviewed have improve have processes. -- our manufacturing in depth alternatives and we continue

side do CMC and the cirmtuzumab. with of of -- have side that We're modest happy grade think plan with we're believe can And under we with already fast a we clinical manufacturing the can that that potentially a we things, the best and things material case TKXXX track produce -- a commercial up we that way some work we both even pathway. keep regulatory that additional

a quite juggling it's course, Of act with finances.

gating to carefully clinical on very related side are be the we so CMC And results. spending to

that out spending. So not skies we're our over getting CMC on

Hartaj Singh

the Great, Thank thank you Jim. you, everyone. Really all questions. appreciate

Jim Breitmeyer

for you your Thank questions, Hartaj.

Operator

Northland The Securities. Byrnes, next from sir. is question Please go Carl ahead,

Carl Byrnes

the for thanks Great, question.

near-term? your on was if there any wondering, results the and congratulations you studies publications just anticipate First, presentation that abstracts were the impressive Thanks. from progress today. I

Jim Breitmeyer

a when the -- is, are this from We easy. yes ASCO an in Carl, you will Jim at us and see abstract -- at the that's abstracts about disclosed week.

Carl Byrnes

Great.

disclosed So on the they'll they Virtual. be what ASCO -- will -- May XX to XX for be that's XX

Jim Breitmeyer

Yes. Yes.

Carl Byrnes

Okay, perfect. Thank you.

Jim Breitmeyer

you, Carl. Thank

Operator

Please go H.C. Burns, Robert from ahead, question Wainwright. sir. a have We

Robert Burns

congrats Hi, I guys. quarter, questions thanks Two if for may. the taking on my from me questions and

it was for CLL? to was you're from to calculus a stopped changes whether I development. I within your and the around wanted saw CLL get one, fact thoughts -- landscape that trial efficacy. your from top first we due positive viewing for the line development And So wondering I the results X superior Phase to early wanted how competitive Unity cirmtuzumab it that

investigator-sponsored agent in TNBC as I within IMpassionXXX patients my exclude so the breast front as specifically second then the that's and trial Now at positive as had taxane? other that question, they to are for front use taxanes exclude, triple-negative I HR the exposure cirmtuzumab HERX-negative prior they both looking single was the cancer noted of line. line who and including cancer, And breast regimen but in given well

it of I about Thank in much curious TNBC if If administered is you. you're setting? of would how development specifically was cirmtuzumab that, the how thinking how indication? is considering data in you're forward, actually moving -- thinking positive, just about the that the frontline you exclude

Jim Breitmeyer

Thank Rob. you,

I'll cancer related So question breast handle let me, first. the

we been investigator-sponsored exposure presented and had data. subsequent taxanes have results so, cirmtuzumab. prior to And the And on taxanes any and including and triple-negative this study not response didn't when taxane initiated, was preclinical

IST And the taxanes a patients is get seeing designed are time. so, we clean for first are -- result to that the with

doing we carefully consider So, plus the we're to to taxane also developing models exposure evolving subsequent we the will very landscape. -- response are for is important taxanes some And an preclinical if prior see factor cirmtuzumab.

it's question. I'm open an saying basically, So

me landscape. turn Frank to to Hsu in CLL the the let discuss So of then, context our over results

Frank Hsu

Unity landscape talked supposedly quickly that PFS The I been the you know Well, that which as data dramatically. point. basis CLL hasn't as or on is released this find out, you so about stopped has about it's study at of as superior could been pointed except and changing was the far

gauge of data So been has to assessment vetted -- fully and that we'll the public. need but or to make released an once that

But The at still effects bit aware not time mature. know you're take PFS relatively early. as moment of on do PFS. can overall CLL, our We the we're a to with

still think I we've some interesting the so, that in And showing past. are very results we reported that

[multiple in it The the whether So is will to an with long-term agent. active follow-up we question know impact or we have enough yet long-term, don't speakers]. patients have not enough the answer will PFS to and that remain

Robert Burns

I'm sorry.

Jim Breitmeyer

Go Rob, ahead. ahead. go

I comments think, are Frank's clear.

Robert Burns

be coming any update, for For -- going mid-XXXX be update it? mid-XXXX, Phase with with any would data the PFS X/X know update, I associated to that be yeah, there there PFS standard associated is in that's going because the to

Jim Breitmeyer

go Frank, ahead.

Frank Hsu

the we can, data much Yeah, how sure will haven't but I'm released be as of as any were much yet. at presented not meeting. we data the embargoed,

Robert Burns

you. Okay, thank

Jim Breitmeyer

you'll a CLL not we single in CLL disease I data -- disclosed progression. we Yeah. event And had that last recall seen March, of when think we that Rob,

XXX%. we're PFS, sitting So at a

And that fingers so, know this crossing is that that we're at point. near of of kind we But course, something might show data, certainly it don't our again. up continuing

Robert Burns

Awesome. Thanks for taking my questions.

Operator

There are to I'd like time, Rich closing turn ahead, no at questions go sir. remarks. Vincent for back the over Mr. further this to call Please

Richard Vincent

updates. And on to stay behalf healthy. of look Everyone you Thank operator. again us And thank you, today. all safe future and forward we Oncternal, joining for

Operator

This concludes today's teleconference.

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

Oncternal Therapeutics (ONCT) 9 May 202020 Q1 Earnings call transcript