Earnings call transcript Q1 2023

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Corvus Pharmaceuticals First Quarter 2023 Business Update and Financial Results Conference Call. [Operator Instructions]

It is now my pleasure to turn the call over to Zack Kubow of Real Chemistry.

Zack Kubow

Thank you, operator, and good afternoon, everyone. for financial Pharmaceuticals results us business quarter joining and update conference for the first Corvus XXXX Thanks call.

with and Chief Executive On results the Research; question will Regulatory by Leiv and Chief President Senior President executive team and and the followed James call Lea, Officer; period. a of business updates Ben open Senior call are some Richard of to Vice remarks, Financial answer Officer; discuss Pharmaceutical prepared Vice The Rosenbaum, Jones, Miller, the Sciences.

would to remind everyone forward-looking I today comments and include that will management like made answers by to statements. questions

no statements implied risks assumptions as today report and by the the risks The with SEC those Forward-looking on from described results law. from of with to may estimates time that company as or required materially statements SEC subject by actual except and statements, Corvus' undertakes to was cause XX-Q, including time. are based makes which filings the are revise any uncertainties the obligation Form quarterly uncertainties to and to on or today forward-looking in publicly expressed and update filed differ and other those company

turn over the like Leiv Lea. to I'd that, With to call

Leiv Lea

of I with Zack. business to over will then Thank you, turn call quarter a our quick begin XXXX overview first the and a financials Richard update. for

The period to XXXX. quarter and $X.X related compared million trial manufacturing in million of was first the totaled in XXXX drug and the same expenses clinical Research development to $X.X $X.X lower for costs. primarily decrease million

Angel which same million quarter Angel to of the million, XXXX in quarter the non-cash $X.X was of included in for related was a net first the XXXX. XXXX. Total loss million, million $X.X period million loss which a in $X.X stock period to for a compensation expense compared non-cash same million for Pharmaceuticals loss The to the $X.X first XXXX $X.X compared net loss related to $X.X included of

XXXX, $XX.X XX, XX, had to and securities equivalents totaling at March December At XXXX. marketable compared as million Corvus million cash cash, $XX.X

we in operating activities full continue XXXX million. Looking XX net to year forward, expect to between $XX and be cash used

the decrease on and prudently most from and on continued burn XX% support our on rate our upon our that focus managing Based believe cash At our provide focusing product help trend XXXX. establishing our cash focus promising this is this XXXX, runway by development collaborations midpoint, a into demonstrating CPI-XXX, we our candidates. will opportunities of

the to elaborate who turn now and will over plans. Richard, call will I our strategy on

Richard Miller

and afternoon, Leiv, you, everyone. good Thank

today Thank for you our joining call. us update business for

be CPI-XXX, our this We T continue or believe represent but lymphoma. new platform randomized broad focus across an to has also patients of only We first-in-class a range treatment the potential with to opportunity for lymphoma may cell important PTCL, T X relapsed not option registration potential and on a peripheral for advancing drug cancers cell ITK a towards trial immune diseases. inhibitor Phase

based good patients on with responses ongoing the important Recent to generated upcoming trial objective in now biomarker count Phase And recently our in ALC. encouraging are; XXX, utilizing we X/Xb enrollment with meaningful data absolute see an continue to findings refractory with PTCL. our incorporated be first, lymphocyte or catalysts continues

mid-June. to clinical Malignant Lymphoma Second, from on trial interim Lugano, we that we Phase lymphoma Conference cell data in International data mechanism our presenting At our at which and will present X/Xb supporting biopsy in indications beyond proposed solid the of T blood T believe additional patients, lymphoma the extends be meeting, from tumors. in potential cell clinical action, Switzerland also we will novel

CPI-XXX a likely during quarter, plan X registration half in the the for year, in FDA trial to discuss second survival. of approximately The be of clinical a be would with Third, chemotherapy T progression-free XXX we monotherapy endpoint intend to to cell standard comparing primary CPI-XXX patients trial planned agents. third Phase of anticipate to lymphoma. relapsed is care a the meet the currently this randomized of We

the ready of constructive the to with Fourth, be we meeting the FDA, the the initiation X including Phase with XXX, plan trial of end assuming a year. before

recent fifth, at mechanisms. novel ITK indicates achieves AACR that responses immune And selective presented to it this solid tumors, through blockade tumors, including data immune enhances and

one fourth on of we At trial. John we the in the Dr. call. hematologist in which Ohio from patients included durable recap, Cancer on saw To recent Whistler for at February data Center Malignancies, our investigators Hematologic quarter University XXXX, our XX, response, lymphoma responses presented evaluable four highlighted the interim XXX XX response in This specializing clinical briefly of a and patients. Global Reneau, of Comprehensive data the as State tumor trial, Summit

Reneau's the presentation likely patients for more also believe new Dr. evidence, to implemented that recently ALC therapy. XXX biomarker highlighted supporting enrich will minimum we respond to

that but treatments absolute not was prior more patients patients. that The to of their count biomarker indicated with new predictive the beneficial with that This XXX, of ALC chemotherapy not favorable value to to was selection response associated predicted to evidence XXX. the the therapy lymphocyte received showed response due

recently our trial. updated Phase from have clinical We X/Xb data the

two There milligrams response. for XX response three one responses, As continue with yet of May the been BID at were including total not patients tumor and tumor complete therapy, for the that five on therapy and optimum response. Xst, responses evaluable A on dose well. and are enrolled doing patients XX evaluated have been nine have XXX partial partial complete two responses. remain patients of nodal of of very are

and responses XX tumor XX.X control responses stable were complete of in greater XX and than responses for six The PR patients XXX partial versus ALC responses with of were than below ALC respectively. less For disease. X.X with ALC above XX median No six months in with seen is XX. includes patients progression-free that survival XXX, months patients CR, and includes disease that seen in objective XXX, with XXX

above responses to in the against ALC lymphocyte with consistent favorable stimulating that's more CPI-XXX. is an XXX. activity with than patients of to are the XXX patients Of course, tumor enrolled required all new greater contributes the an response data The immune being have our absolute count

are by and and enroll results continue the confirm extend in to We findings. will encouraged we to order these patients

also BI want studied of trial. the a dose is say I safety. of XXX in we about The top one-third milligrams to that milligram dose the word XXX BID

We We any should ITK seen have drug tolerated other milligrams shown complete therapy. of dose this be including very toxicities combine well dose-limiting believe XXX that dose and achieved types with nearly cancer occupancy. were the XXX-milligram it target BID. to in is easy No group,

The at renal, Cancer a for treat cell supports cancer that our targeting annual the demonstrated response CPI-XXX and Research B T and lymphomas. In to hematologic and Association colon, models several immune potential April, as the preclinical ITK team melanoma presented meeting solid enhanced to approach that data for new American murine of including data cancers. tumors, both new immunotherapy, including

renewed revert their and capacity. T are findings them capacity to T exhausted In into of become XXX cells T was to reverse reduce shown the killer was infiltration with addition, to cells other XXX shown already which T ineffectiveness. active reprogrammed XXX increase cells to can which cells. recent effector chronically to killing with findings, effector causing that the increase cell In stimulated More T T cytolytic antigen, occurs when show leading exhaustion, tumors and cell

T cell and they from that T new effector action ongoing tumor. number our two, data preclinical mechanism a of includes; cytolytic We to to ThX Xth, of novel our immunotherapy three, the cancer CDX X into with of lymphoma cells cells. Phase And believe in a exhaustion. the key opportunity number reiterate approach trial skewing. findings now induction of of reversal cell want infiltration significant Number may recent and with CDX increased suggest selective one, a ITK I reduction broad inhibition capacity XXX. T because represent increased

and U.S., property methods not in and extend of of a China to inhibitors the believe use strong are already. other position Europe, diseases. continue and other property of countries currently treatment development. intellectual patents for the autoimmune any also selective clinical cancers Composition-of-matter XXX our have issued Japan, aware have for ITK We we and CPI-XXX in We intellectual covering

Turning is first-line Anderson ipilimumab University Texas Research Xb/X triplet as briefly in combination Phase ciforadenant a The partner-led of Consortium led cancer metastatic renal to with Center, of and therapy patients MD Cancer for potential a enrolling programs. Kidney trial our Cancer in currently clinical nivolumab. by the cell

we a end of open-label in believe get this reminder, efficacy timelines, is will data initial single-arm Based before be that XXXX. As an this trial, we available we from for could so the trial a current the on trial. feel anticipate early good

head in trial partner, and X/Xb enrolling in cancer our relapsed/refractory in mupadolimab, non-small patients pembrolizumab patients squamous is Angel and China Phase together cancers. For cell lung cell a and clinical with mupadolimab with neck alone Pharmaceuticals, with

CPI-XXX, In the the Corvus uniquely inhibitor development. positioned is with of most ITK advanced closing, in believe we prioritization

regarding increasing We are a and laser-focused confidence broad range its cancers gaining of diseases, on autoimmunity. including activity XXX and are in

work, role Our from system. the others, in are ITK confirming recent crucial with immune that the publications together regulation of plays

lymphoma, to T indication, initial a represents unmet clear registration. cell a Our and path need potential

a discuss and Phase in trial as therapeutic of at interim in presented CPI-XXX, our at from Phase trial in include; X/Xb lymphocyte count; XXXX. randomized the milestones the quarter; lymphoma T CPI-XXX be ciforadenant continued data third the programs our for in with use absolute our updates the We providing new to key establishing to cell are enrollment our data Phase X of FDA programs, look end The a updated importance from including the of of dose We milligram June; coming trial initiatives BI will valuable XXX ITK trial biomarker, quarters. forward these target. our partner-driven on upcoming the key the from we anticipate Lugano meeting before X

turn over period. and questions now will the to I answer call operator the for

Operator

Huseynov Instructions] comes first Aydin from Thalmann. question with [Operator Ladenburg Our

Aydin Huseynov

you And the two Thank you. want team just -- you like everyone. it I and Good Richard responses, partial update. new from to confirm, batch responses seems the afternoon, more have with data? have of Congratulations,

Richard Miller

We let's see, two have, responses. more

Aydin Huseynov

had update right? Compared at call of we the prior to end March, the that

Richard Miller

Correct.

Aydin Huseynov

progression-free ask let about me So you survival.

months. XX.X mentioned You

give So little based bit calculation? on this? clarity Could how more this many patients you a with on us

Richard Miller

patients. based that's on So XX

Aydin Huseynov

meeting the time, to regarding third I bit within think And more quarter. FDA, clarity. that This little a with happen mentioned is this that's going you

you meeting? other some Meaning, anything you this randomization this a out meeting? from you're what Do you you planned? other primary PFS do new X:X trial. any or Do surprises expect the any details randomization than trial, -- So come what planning will randomized endpoint. expect So of and think XXX-patient

Richard Miller

do I expect surprises. not any

at is for I trial cell is registration a for lymphoma. randomized protocol trial. What T think of we're would looking meeting positive, this agreement properly our pretty controlled designed, product support and if that is straightforward. this It's the

discuss things standard of want I with therapies we choice think in the that are control the to them arm.

be monotherapy standard therapy will it lymphoma. cell mentioned, T with XXX So versus I as a for

would standard will one Pralatrexate We're add Belinostat used which about now for for the drugs. cell lymphoma, cell that other thinking include relapsed know. therapy used probably T that widely approved to as than the in drug three commonly T and lymphoma. And are more would is list -- fact, be gemcitabine, peripheral for drugs you approved

So would their with allow if three arm, pick them to the drugs. discretion randomized is investigator patient investigators, those the control of one

of median I So cell by Aydin, just relapsed few is lymphoma be PFS around design in or the that approved in there an usually past, the the least there the at don't used drugs T think have two the getting trials, and really I too since think United been of But gemcitabine kinds a are standard the done agreement Also, it's already of is three people, will months. and controversy four much for these therapy. States, majority on there. for

pretty that like. expectation the a So we good of control would I think group have look what

Aydin Huseynov

So drug calculation can around you on envelope XXX it's on group something the and above ORR four kind back is is XX% the show this months ORR remind what far. of the XX the months approved But side, versus so side? or on your ALC But chemotherapy historical drug. you for -- historical us what that showed so far, three, the on that the

Richard Miller

XX% short responses. and very

other data yes, we're XX% confident way, of day. response -- that One the example, PRs are PRs, you seeing, XX%, responding, as for feel of saw those still by other the the the the I some

with So of can that obviously, some change time.

reproducible. That's As It's standard mentioned, agents ORR about is the short-lived. XX%. pretty the I with

seven BXX significant vitamin the vomiting, of very days give have Pralatrexate folate the XX suppression an they're five -- approved And Belinostat, any seen things but days they're and a and those attention very meticulous marrow of is a is is example, six agents significant bone toxicity, about days intravenous being control a before metabolism, for and of one these of And difficult one toxic. every in have out to hassle. other to administer weeks, haven't three pay row, to suppression you bone injection, drugs It's XX weekly we think infusion, and I weeks. after. that marrow really quite nausea, that. agents

I be endpoint, endpoints survival, also should but PFS rate, response a secondary be life following. and one will response are add, quality of of that overall life duration the we'll is our assessment as well. primary Obviously, quality of of endpoints

Aydin Huseynov

Richard, given enrollment the chemotherapy FDA this randomization? the X:X administration and expect difficulty with would in of proposing you drug,

Richard Miller

Could you repeat sorry. I'm that?

Aydin Huseynov

randomization To opposed propose as to X:X X:X?

Richard Miller

and going over. think -- first that. don't that, of be that would a X:X powerful we're doubt is study No, because expect all, statistically allow I to wouldn't do I cross would I they more

when the they arm, progress, control the they over on patients treatment. cross in to can So

Aydin Huseynov

All right. Okay.

congratulations so much. Thank additional Richard, the congratulations with and you update responses. Okay with

Operator

Thank you.

Our Li Watsek with Fitzgerald. from comes Cantor next question

Rosemary Li

Rosemary this for for on our questions. is taking Hi, Thanks Li.

Just two from us.

XXX, in So diseases as potential mentioned well. for immune you've

your initial has is plan for seems So timeline bit. would ciforadenant, the you a partner And shifted or going to to consider a indications? it find generate those then data for there directly like some

you to or follow-up have So reason? to some possibly longer the give or wanting due us just it's color around could Whether a something? enrollment

Richard Miller

question First was...

Rosemary Li

diseases. immune in XXX

Richard Miller

Yes.

in in excited that, XXX's some in you striking haven't AACR at groups because we that about shown models have a impressed data, genetically another ITK enhance very or look it We're can -- take seen a scientific drug there's been of are our if really that very cancer. using blocking anti-tumor animal also either responses. should So The activity couple you that there. findings now

T on lymphoma then now laser-focused solid cell tumors. and are we first So

got XXX a interested getting into already study. I've who a medical of really solid couple tumor in centers are

it. data take already to because in priority immune obviously think there clinic. a about that going I have We that's know the the So diseases over we lot

approval think is bit and little terms And is easier product something of in cancer a I development for us. that pathway

of to not in Now immune or year. move whether we're diseases, later immune considering XXX with into terms this still diseases

cancer depend I the to However, going we think with make the area. progress in cancer on that's the

back-up I also mention that the several slightly next-generation that Now things to should ways. one of ITK that is block XXX we or in compounds compounds different have

Some of them have structure. similar chemical

the that additional inhibitors chemical probably be different structures. even been really of we But make some turning adjust think ITK it's that can even on future biologic how better designed Some these I autoimmune diseases. we've them to have fascinating specifically properties. doing work for drugs and make we are And out can in the -- certain

your don't done. no to, slowdown but enrolling frontline referring what ciforadenant, on It's the there. question is I cancer you're kidney Anderson Now know being next patients. MD

review a all have to at We meeting that ASCO stuff.

PRs and deep about CR are on feel, board. and get PRs. call, MD and trial are actually. an is complete endpoint getting And institutions the literature deep a Anderson can what CRs from we we'll in -- Other It's open-label CR, the we responses XX%

to XX% more deep CR, only the are than looking by way, PR. be about see And CRs XX%. we'd So

a also be So of encouraging. couple CRs seeing highly would

I I for It's the equals And other think. can new together think just then therapy. the to one putting XXXX such anti-CTLA-X It we plus three adenosine reasons with cifo well And finally, done based not In on that two. one biology, wasn't goes and was the done AX with I a ipi/nivo, another antagonism add that a words, just that biology. equals word in plus immunobiology time, a one really drug. on that showed which one a had it's but really, go also was publication into it that's

Rosemary Li

Thank much. you. Got it. Thanks so

Operator

you. Thank

comes question Mara Mizuho. Our Goldstein next with from

Jerry Gong

questions for Jerry congrats on Goldstein. Hi, Thanks the this updates. my for Gong on Mara is taking and

And So the six first, milligram for are at number patients. the all the average show patients XX of evaluable scans the had? CPI-XXX you dose? Can have efficacy additional patients evaluable if XXX

Richard Miller

you of two What scanned talking three The scans? average number number the months. mean scans? are Patients get about? of to You every

Jerry Gong

have what patients? guess, evaluable guess, I is study the the for XX time, efficacy like for, like the I been time median -- on patients

Richard Miller

handy swimmer therapy, there. call, of plot waterfall time our I don't plot you was there a conference at on median now. But last a look back if The have right and

go people had been Jerry, at information guess see still you now, again, including on long If on If look on that, to that therapy, months how detailed those have you'll but therapy. don't have Six I have handy. I patients or more, information several PRs. we

to like something more therapy months coming me in on it who think a XX%. Actually, -- on six are second. Hang is our is back than The now. of number study I patients

median the at look guess. would at the last call. I our that look more that -- means data be our from So than But

Jerry Gong

We'll -- milligram even on six study the are the do. all I all I efficacy dose? guess, are still, patients, evaluable all are patients they additional remaining guess, patients at XXX and new

Richard Miller

Yes.

Jerry Gong

scan, For initial the their you without can is? five share remaining patients what ALC

Richard Miller

all started months that we think XXX. I I ago, because started implementing XXX, all they're above few above December -- yes, a implementing they're We think.

Jerry Gong

me. question final And for

ongoing So the many to the earlier. -- you to guess expect a end for year? How of do the share by from the ciforadenant follow-up data or question be able patients I to

Richard Miller

than some XX. more With follow-up,

Jerry Gong

questions. Got congrats again. it. Thanks the And for our update on Awesome. taking

Richard Miller

you I right. Jerry, guess. Mara Goldstein Thank - you All equivalent, thank

Operator

Thank you.

Roger with next comes Song from Our question Jefferies.

Roger Song

A Thanks quick Great. for one. right. update All taking and question. all

solid for Thank have just plan, for that there? you AACR timeline the this so look potentially clinical So for other Phase endpoint. PFS the data fighting or take data, internal endpoints early with any do also at you interim primary plan ORR you. tumor And some in look? the the will for the the XXX TCL, X as that you possible Is or do understanding will some

Richard Miller

with is accelerated on FDA and interim the do plans the from guidelines median that have came a the an data not I'm promises you response rate do versus would approval. endpoint. sure to big there's final look at that any event-driven the for is evaluate time yes, time short reason in look the don't controls And rate consistent we make about for I want that to recent So that. between response to waiting when early progression so difference

You follow me?

Roger Song

got I you. Yes,

Richard Miller

those makes would almost be disease, course but look I But of not that. I'm to we that's thing another sure would course because difference. might going big it's much be doesn't That I And matter So that of months particular a difference, few be relative. could this is FDA. different. discussed in not significant. with it be say, the timing at be mean, I so could a -- that It to -- guess, it

then renal And talking have in looking question plans PD-X-resistant lung melanoma as a PD-LX good a been your solid the definitive of diseases would example. like about any we now, with have to patients, who at received cancer, for tumors, solid there's trial. right when is, drug we But thousands people on the we've thousands. don't and start cancer, agents, The news anti-PD-X, lot patients and tumor

is, patients there's a respond Most of patients. fail lot either a recurrence. The eventually resistant it, bad don't have or news

of is one things that in interested we're particularly the so And mechanism of resistance.

as those cell I work on Obviously, now right so laser-focused in getting And going quickly the on. and lymphoma T as my -- talk, discussions mentioned still going are as possible. that we're we're

Roger Song

Rich. you. Thank thank you, Right,

Richard Miller

Thanks.

Operator

Richard Thank This session. turn remarks. question closing Miller like any back concludes and the over I to conference you. would our answer for to

Richard Miller

the future the you to everyone the in thank make. and look Thanks operator, on participating in we We progress again. updating you, Bye. you for call. Thank forward

Operator

attending has now you conference presentation. Thank for The concluded. today's

now may disconnect. You

Corvus Pharmaceuticals (CRVS) 8 May 232023 Q1 Earnings call transcript