- Earnings call transcript Q3 2022

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Operator

Good afternoon, everyone, and welcome to Shattuck Labs Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the call over to your host, Conor Richardson, Senior Director of Finance and Investor Relations at Shattuck Labs. ahead. go Please Conor,

Conor Richardson

our Good on call and XXXX regarding business of and shattucklabs.com. release and operator. market website, issued Shattuck this our Events close financial to & Labs recent afternoon reporting press A conference our be updates. results afternoon, you, was welcome after found everyone, can the results financial the Thank third section quarter Presentations

XXXX, the including team leadership development During this third provide business our quarter overview the of SL-XXXXXX. SL-XXXXXX, afternoon's from will of and clinical a updates Shattuck program call, lead

and We will refer XXX to throughout earnings these as XXX call. today's

by Speaking Co-Founder, Chief Lini Dr. who be Dr. Officer, will our then Medical our will Scientific who Pandite, update will on Financial XXXX Chief provide Schreiber, and Officer financial Andrew followed financial will our activities review and Neill, upcoming on our review guidance. our today's results Taylor quarter and our and clinical pipeline Officer, Chief call progress an Executive milestones; third key

will for closing the Dr. after call questions open some remarks. makes Schreiber We then

implied to XXXX. Before management's as safe you differ the and risks begin, of cause results Securities from of could and harbor actual like Act of forward-looking remind the to represent these materially would I contains provisions that today's expressed the Reform Litigation may involve Private Such by statements within or statements we of webcast meaning today in judgment uncertainties that statements. those

X, views today, Dr. Schreiber, website, I on our with forward-looking shattucklabs.com. refer SEC, on our or XX-K turn ended statements from our Form available the December November XXXX, more year represent these For uncertainties, our to as our With Any other Executive the recent Chief most Taylor? over now for will information on filings Report Annual SEC's Officer. are and and to which that, the call corporate risks the please of XXXX. website XX,

Taylor Schreiber

us job an joining stage checkpoint our been operationally you our afternoon, done and clinical XXX, an or Shattuck, Good advancing everyone, Conor. today. you, focused compound. excellent XXXX year of thank redirected for ARC has Thank and team agonist lead for has clinical

As Fc therapeutic macrophage known fusion and important all both molecule differentiates SIRP-alpha as to from a bi-functional functions also as single XXX inhibitors clinical a in two CDXX serves immune-stimulatory which the XXX checkpoint activates protein, CDXX. CDXX block known reminder, within receptor Linking these other CDXX is a development. an ligand

portion has for hear reached XX study. for we the and selected we per enrolling the first as in milligrams quarter, per level the in cancer monotherapy combination the chemotherapy XXX dose moment, kilogram advanced kilogram, excellent quarter will year. the As from clinical team second enrollment progress maximum a in a dose cohort. our of you highest patients the third escalation in combination Dr. in Phase the have made of X In platinum-resistant our of XXX starting I level anticipated this we which this in completed in Pandite ovarian dose trial was with administered and patients dose cohort began ovarian cancer, milligrams

of antitumor These As agent, their on studies CDXX eat-me doxorubicin following combination selected the that an to for demonstrated surface initiating liposomal in the exposure cancer response or proteins the express chemotherapy essential inhibition. we liposomal with combination prophagocytic signals cells because ovarian doxorubicin. are to preclinical eat-me setting

patients. small this doxorubicin. has in us number a components agent cancer XX% of addition, range platinum-resistant a the with to clinical decipher trial the contribution setting rate liposomal established response Thus, ovarian XX% for experience the allows design of In of decades several to single relatively of in

primarily population. improved other patient then from the to population this syndrome cohorts began CDXX patients in would in inhibitors year, frontline in the where dose the room disease solid differentiate agonism may has XXX believe and in any recent XXX year. this addition cohorts to cohort updates and may in CDXX fourth CDXX Patients lead planned patients will for for of with with azacitidine this quarter that and and left inhibitors narrowed subsequent durability. relapsed/refractory XXX enroll The leukemia blockade, first-generation our escalation of this increased activity development setting of a enrolled responses addition with quarter in in the in clinical patient the first patients to clinical significant We expect have myelodysplastic acute in combination response of the and myeloid complete enroll differentiate rates for program expansion which to will we tumors, CDXX high-risk In we the study improvement. second

XXX, compound, protein with PD-X-Fc-OXXX is stage I patients development in tumors fusion and bi-functional Phase clinical second lymphomas. Our a solid advanced ligand for

dose continuing are tumors XX the PD-LX line escalation the anticipated of XXXX. are level dose kilogram patients milligrams top of first We the top to with I data from primarily enroll trial selected quarter at in and Phase per

programs found truly activity gamma continued approaches currently due we distinct As development to pipeline, from design the features. GADLEN believe tremendous of Interest in cancer cells ARC with Journal we've website. unique our on our the past multiple build, per our platform and delta harnessing preclinical has Shattuck's The T in all preclinical to of quarter in GADLEN on which Immunology, in progress publications and made over can be its is other

of will this call being biology, BX-HX And Our non-human a range key team for our for non--Ig diseases. Society solid has sharing our in aspects expected. strategy. Conference for considered delta to gamma guide is gamma uncovered Immunotherapy Lini? clinical is and Dr. presented which dose at and data Cancer delta cell preclinical will of The forward will turn published of additional amenable be later of T modular will the highly week therapy completed over some and to one targeting is has GADLEN from be another GADLEN a candidates, Medical and design product antigen, platform separate toxicology to in to included considered and the finding presentation. CDXX monospecific, where more being autoimmune CDXX targeting the be antigen Officer. GADLEN SITC BX-HX The look and X Chief advance. data bispecific variety biparatopic single-agent Annual is I the B-cell the Boston. as as indications that, cell a data Pandite, The study depleting efficacy based the With tumor T antibody-driven space primates continues therapy The now would in We

Lini Pandite

clinical good extremely programs afternoon. with of Thanks, have I'm the Taylor, throughout and the the and made execution we progress our pleased year.

to our first differentiated inhibitor XXX, turn and agonist. CDXX Let's CDXX

presented antitumor safety, SITC of platinum-resistant driven XXX open-label, intravenous a trial from multicenter, and is by Initial Our escalation to tolerability, high-target trial effects of at of activity and activity monotherapy pharmacodynamic in cancer. safety ovarian a favorable pharmacokinetics, CDXX first demonstrated patients activation. this dose on-target occupancy intended as administration clinical data XXXX profile, assess XXX the pharmacodynamic clinical trial with

announced per not window the near of XXX to recall of provides the quarter, We last us a in we can kilogram. target enrollment anemia, to and reaching we biology therapeutic Fc we occupancy which the that of will CDXX, the believe absence receptors. XXX maximize of safety of we potentially To design the current the date, completed CDXX. the you while gamma XXX% As in observed binding profile of with portion attribute which of dose any from evidence Fc have XX administered destructive that maximum have of milligrams level we

in we data year, the report quarter by from Phase doxorubicin third to this XXX and our trial trial, a tolerability, expect to dosed dose liposomal in the trial with first combination of escalation with midyear We cancer. progress is in ovarian in trial the multicenter, of antitumor activity the evaluate Ib this of with I'm Phase in liposomal XXXX. doxorubicin. This patient clinical of pleased to the patients that full safety, portion in Enabled combination I say platinum-resistant intended pharmacodynamics XXX open-label our pharmacokinetic,

data combination We expect XXXX. trial midyear to from this report initial

to turn trial, safety, XXX progress us in Ia/Ib trial MDS. in clinical of trial in I'd our XXX this monotherapy azacitidine. where AML hematologic Now, in and pharmacokinetic, let tolerability, Phase In combination and malignancies, like clinical and we activity the highlight effects are the our evaluating attention made have antitumor both higher-risk to as pharmacodynamic with we our

of dose patient population, the escalation few, heavily relapsed/refractory if consistently led reminder, this part combination parallel agents pretreated is where a a in monotherapy staggered have any, to trial responses. and first As complete

combination result, a Initial are XXXX. the any the azacitidine monotherapy first combination enrollment to and in monotherapy from dose begin nicely. Taylor is where an differentiating As be compared to complete area this could has enrollment pleased responses as escalation particularly azacitidine expected in trial to, half cohorts agents. is CDXX data the to the report XXXX. I'm fourth alluded progressed cohort of in signal, in a of quarter And this of expected other that the

pharmacokinetics, Our the antitumor tumors open-label second clinical is of candidate, and XXX, solid trial tolerability, advanced activity pharmacodynamics multicenter, and in XXX evaluating clinical lymphoma. a patients with safety,

will you escalation we As and data evidence pharmacodynamic dose-dependent activity. the per I through trial, initial X previously antitumor recall, dose reported kilogram clinical of from activity Phase ongoing milligrams demonstrating have

enrollment completing this per fourth enrollment XX of the kilogram anticipate We milligrams in year. quarter have in and the completed per milligrams XX the kilogram cohort in cohort

expect response to for quarter from of patients, the we line in these the in additional allow cohorts to assessments share and result XXXX. top a As first data

inhibition a are discussed has high such patients and of a naive way we to evolved both in world. PD-X that landscape in geographies all is extremely before, nearly around difficult that As the PD-X at enrolling responding likelihood have PD-X the

in see We XXX XXX. or the response the to PD-X discuss rate viable be to in our over turn would to patients. now a a the I financial call part to path Neill would will such, As relapsed/refractory update. Mr. clinical patient forward that, additional cohorts greater for first Andrew? XX% With overall see of need

Andrew Neill

afternoon, Good Lini. you, Thank everyone.

in XX-Q. outset few results third at for I earnings from press disclosures. available forthcoming full the the financial of our a As Conor in mentioned to release points are like the focus our XXXX on our and key quarter of would our Today, call,

to continue well financially. be We positioned

quarter $XXX.X quarter the $X.X of XXXX. the expenses of third of compared third In XXXX, the million our million million cash have third for the for to of quarter As and were XXXX, XXXX. of million. and cash our third XXXX, September million investments and to and In expenses were administrative compared $XX.X approximately quarter equivalents $XX.X general development of research $X.X XX, we

loss our share. a and third of of loss diluted or our we $XX.X or and share $XX.X diluted financial for development of the per of compared was a XXXX for third $X.XX current XXXX, for guidance and basic reiterate loss net million, net the on plans, to and Our million beyond. $X.XX Based basic per XXXX quarter quarter operating

sufficient of XXXX. half investments second into We cash to our the fund our and equivalents existing expect and to cash planned operations be

it our projected operate including financial of we in We continue ongoing as entire position programs. cash strong given burn, and to relates clinical balance Dr. rate sheet healthy company, a to with across back I'll our our hand comments. And XXX for in our that, clinical final XXX to clinical are call discipline Schreiber our Taylor? for With expected and data readouts the trials.

Taylor Schreiber

Thank you, Andrew.

kept a clinical opportunities have you both to XXXX are ARC As in we just with our heard, be the and has clinical platform. data pleased quickly, we our heads those ripening year execution with XXXX. the down approaching have pipeline platform of further are which now in been key and on GADLEN to broadening Both focus

patients, also from from patients doxorubicin, from data study ovarian and monotherapy As platinum-resistant expected in in in ovarian XXX cancer the complete initial the updates clinical including data escalation you with cancer midyear heard XXXX. dose Lini, liposomal are combination program,

data expected to call. patients participating half in in well in beyond transformational Additionally, of incredibly today's as higher-risk We believe resources the XXXX. AML engineering, initial the are science to combination and our experienced everyone, and MDS our want first team, next of relapsed/refractory puts position milestones. in of thank, as for move with us I set from our protein an financial strong study

for We we you we questions. progress open corporate our objectives. execute and of the strategic With apprised to Operator? would your keep now call will continue as to that, our like

Operator

question from comes with Frahm Our Instructions] first Cowen. Marc [Operator

Marc Frahm

pursued earnings an my Thanks the time question. on milligram the doxo advanced the into guys last and for about quarter -- trial, you being that being you X in all? talked will seems XX to or call, unlikely dose milligram still it whether the cohort taking Last to need the reported spoke the while combo will Do monotherapy you monotherapy XX-milligram that think you going data using the enough dose be from be over. was at now confirm combo in not in to you have was

Taylor Schreiber

thanks the Marc, question. for

me Let Lini take ask to that.

Lini Pandite

Marc, the PK/PD all support kilogram X the evaluated combination. per our dose analyses milligram being in

solid very dose, the is protocol on up the a Our us X milligrams for evaluation go dose allows combination. but to in

Marc Frahm

you That's help some infusion you've can how the on were the with longer helpful. in the and you dosing And that's then to also extended are evolve? confirm, us infusion with combo that. reactions Can Okay. the to continued time experience there And then of time early trials? in monotherapy, kind using update you

Lini Pandite

Yes.

hours, We hour. one are is which using over longer two hours two of infusion over time, instead

Marc Frahm

thank Okay, you.

Taylor Schreiber

Thanks Marc.

Operator

next from Jon Evercore your Our line Mr. Miller question ISI. live. is comes with Miller

Unidentified Analyst

asking is SL-XXX, on platinum-resistant [Technical looking at for Miller. the trial monotherapy cancer… Eric here, Hi, On this ovarian Difficulty] Jon in

Taylor Schreiber

This is Taylor.

You there. Could Evercore? the and to question? the we go trailed question off repeat maybe Operator, you to come next back can

Operator

Absolutely.

Our with Needham & Blum question comes from next Gil Company.

Gil Blum

everyone. Hi good afternoon

any dose, purely Just per dose this mg quick question sign on a toxicity based a or was is kg decision there of that on at the XX PK/PD?

Taylor Schreiber

well. Lini to over Gil, turn Hey that I'll as

Lini Pandite

dose analysis across gives full the on-target it a and And pharmacodynamic is X the gives very gain from and receptor activity, not dose entire milligrams to occupancy, It's good milligrams. based per take an to the up on all Yes. going XX decision you much -- kilogram did We actually dose that dose range forward. PK/PD. is a there

Gil Blum

ahead be for kind It guys of have. would not very looked view you any you CDXX have magrolimab a MDS. looks the abstracts that I'm do of mean, sure And in may Okay. published you helpful. one, guys guys That's doesn't there's high-risk were benefit I it. at on ASH? like the much thoughts more I appreciate speculative any for

Taylor Schreiber

Yes.

additional to comments. So, and some chime with want may start Lini in I'll

we've I that full being the in towards of necessarily to of that updated trends it some patients both, detail means. I response statement studied make is a I from to abstracts, say the is there's is think I alone at single-acting ASH. the beyond both chemotherapy-only population the make CDXX single-acting that not non-TPXX-mutant that caveat non-TPXX-mutant the the patients combo the expect we've believe far, other magro into AML inhibitor evolve. And CDXX HR And where mutant in would guess heading the And convincing and in what AML, continue for whether you it's were adds think trial of would data ALX CDXX what I with activity would quite and and most abstracts inhibitors, -- seen the len TPXX will between in that azacitidine enough think field recently, I assessment margins in least activity each then on MDS we is inhibitors seen to the the the something so my really the what as to from a backbone. AZA

Gil Blum

I step Thank right, color the queue. appreciate in I'll back All and you. the

Taylor Schreiber

Gil. Thanks

Operator

Nochomovitz from comes question next Yigal Our Citi. with

Carly Kenselaar

we guess, XXX the complete meaningful. many patients and first have remarks of Yigal. Hi, Thanks questions. monotherapy point elaborate you and roughly sort bit for the much the how should population I taking like so azacitidine I this this combo on is responses what just AML for I on to our But on year. sort combination the in of one on this cohort. expect see the in that know you of specifically mentioned next MDS with comment update can would And at any Carly for can efficacy? prepared you're for on you half be the in both looking a

Taylor Schreiber

also. that take to Lini ask I'll Great.

Lini Pandite

Yes.

dose the So escalation part.

azacitidine So dose dose escalation then combination there's escalation. there's and a a monotherapy with

And then so dose XX and we anticipate remissions. across anything from XX second patients the regarding escalation. question your between complete the And

in unusual to usually it's So patient complete population, population. in remissions that patient -- see the relapsed/refractory it's

would for to agent. this see complete So remissions, were differentiating if be that any we

Carly Kenselaar

then And we quick clarification helpful. had one question That's also. just Okay.

do the azacitidine, now it planning there with if Could just to but also what just a like was? might with looks combination were was change venetoclax, a you previously, you doing think azacitidine. be I you reason clarify and

Lini Pandite

Yes.

azacitidine, in escalation dose So then venetoclax. with azacitidine expansion get a is dose to and we combination XXX, the cohort once is with azacitidine, of an and there SL

a running a is an It's safety safety expansion. by followed by expansion. there followed an So running,

Carly Kenselaar

you thank great, very Okay much.

Taylor Schreiber

Thank you.

Operator

question [Operator with Pohlman comes from BTIG. Our Instructions] next Kaveri

Kaveri Pohlman

Yes. Good Thank updates. the for you afternoon.

different the types, how this ovarian which cancer. with about efforts is talk you including approach its ILTX can from has space macrophages? into believe also tumor targeting, repolarizes XXX, expanded Merck I For multiple

Taylor Schreiber

Sure.

this enables cells to axis So aspect are a the in their of biology, phagocytose consume -- is CDXX that macrophage particular which addresses or tumor macrophages proximity.

of number And so itself and is is polarization of influence activity the that activity in that directly ILTX something There are of to addressed not a by an an agent. specific macrophages. like ways

be can macrophages Some immune-inhibitory.

macrophages Some immune-stimulatory. macrophage, guide that in certainly, CDXX that role a MX you phenotype. stimulate toward it be Interestingly, decision. CDXX does can immune-stimulating And phage ILTX that cell on well. can And as when a helps play

so that like agents, similar some prophagocytic of an the CDXX addresses somewhat as And the CDXX agent side, is ILTX whereas XXX inhibitory a I the of biology part a believe macrophage on aspect purely function.

Kaveri Pohlman

And That's you. benign cytarabine is data, on safety Or based on AML, cytarabine the looks Thank cancer because with too enough? the for it profile any very helpful. ovarian thoughts combining immunosuppressive?

Lini Pandite

also. cytarabine dose as the So matters of you is said. immunosuppressive, It just

So, trying cells the to activate. that deplete actually you're you could

Kaveri Pohlman

And maybe one it. GADLEN. Got last on

my So, BX-HX you ARC for for several have GADLEN be have I you question really assets? target a ultimately is guess and GADLEN independently partnering indications. opportunity? do used potential like ARC a And develop Or both multiple aspirations asset. programs is, to GADLEN, could for

Taylor Schreiber

what could engager number offer has in interesting think is programs conjugate our think can offer one. I something type of quite gamma with BX-HX. pipeline one of that's targeting could. is expressed. shown antibody drug some broad data their agents widely one in a delta compelling a mean days. from Daiichi we these a tumor it's just that's the types. distinct And it that platform Sankyo an we of tumor antigen molecule and certainly is The a BX-HX I have recently And GADLEN BX-HX

also So non-small abundant, like number interesting lung two expression tumors melanoma, delta standpoint T of gamma include where that are cancer, are cell bladder BX-HX cells tumors a a from others. relatively cancer,

And toward so proceeding IND. of for development agent the with now, this along we're

just And leave so I'll now. at for that it

Kaveri Pohlman

taking Thanks sense. questions. for my Makes

Taylor Schreiber

Thanks Kaveri.

Operator

And our Shu last with comes question from Zhiqiang Berenberg.

Zhiqiang Shu

Great, my a questions. thanks I taking have few. for

details changed mg are dynamics a on lot mg a bit this time. a willing to first APD the I since last and around discuss X and you're dose call X this year dose, So XX more willing at the per more Slide little you per wonder discuss if there? kg kg one have -- to a did I time, things of guess around and you

Taylor Schreiber

Sure.

So, fill I'll start and if gaps of in Lini any can the missed then them. I

So were impressive number and by the near a were X and as thing maximal CDXX, and CDXX we that milligram of kilogram dose, CDXX maximal CDXX-driven to and saturation types and monocytes attributed that cells margination cells were achieve B saturated we when CDXX-expressing monotherapy effects was were knew plateau. identify those you dose a rapid hour we the see we to per we CDXX hoping the in to achieved pharmacodynamic was of spikes where of of milligram kg. and X include XXX some pretty And of were to that inductions well that where infusion, conversations dose we in over moved our we fundamental see tolerated, fully the saturated, where a mgs was and from of study binding prior We the course biology starting large the was an cytokines of of of blood where might as that X blood. consequence CDXX remember per to what the the data well fully maximum escalation the things had CDXX shared XX we in presentation of within -- the of the from or peripheral cytokines at SITC expressing the as migration out CDXX

odd you is at effects further effects, stabilization all Many and do other we of pathway. likely dose are bell-shaped milligram to of see with those those drug that curve And so a indicates that aware those maximally of in when those potentiation pharmacodynamic XX milligram pharmacodynamic saw it that reduction or be to effects might you is go that CDXX a fundamentally, some to of we plateau a remained this what response agents, we're see maximal what plateau. pharmacodynamic effects? from tough And asking maximal the X a of a XX, we

Lini And on X to any that looking kilogram endpoints in there milligram so kg continue dose. before, the based with alluded to between and mg dose, as per at per wasn't XX benefit XX discernible those

Zhiqiang Shu

question think was time, Great. it combination I around ADC, folate with on That's the is was helpful. posted then And second clinicaltrials.gov. disclosed receptor last

there? to Given was willing your I update today, discuss the if you're plans wondering

Taylor Schreiber

Sure.

approval first of awaiting, an all, So any by hopefully, now. eagerly accelerated we're day for ImmunoGen mirvetuximab

something I for think that's question, the And potentiated need tumor mirvetuximab that I initial it could it about And durability XX%. it with I we them exactly least new that way, with -- about that tumor is levels to to conversation. there think platinum-resistant expected about begs very express that mirvetuximab greater drug levels the opportunity starting one cancer folate shrinkage news quite sort long then if was tumor really haven't it's folate the the shrinkage the XX% along at lower ovarian like continue could XX% to that killing tumor, an therapy of XXX. to time. so expression, approval an combined durability And things a had alpha But we'd or of and get exciting patients that greater. accelerated a in where that leave or opportunity in of of hopefully love seen receptor in until is available see for And of with patients delivers. be on of a receptor has high we label interesting clearly patients signal ImmunoGen initial initially their the at to that alpha lead

Zhiqiang Shu

can, I if And Great. final question just on XXX.

provide will of You're an drug escalating in still the quarter update 'XX. and dose first

you are program not this still we if wind that So down? under will seeing the assumption operate I XX%, wonder, should

Taylor Schreiber

operating Yes, assumption. that be your should

Zhiqiang Shu

much. thanks Okay, very

Taylor Schreiber

Thanks Zhi.

Operator

to Schreiber, concludes turn the over call question-and-answer Officer Labs. Executive session. of the That Chief back I'll Shattuck the Taylor

Taylor Schreiber

concludes This the Thank all Shattuck, in of milestones throughout the for we Shattuck Results appreciate of and XXXX. Updates Q&A you. your Third updating to Financial Call. joining remainder Thank interest our Thank forward Quarter Labs call. Conference session you Thank look and We you you. Business continued the on you, operator.

Shattuck Labs (STTK) 12 Nov 222022 Q3 Earnings call transcript