CMMB - Earnings call transcript Q1 2022 | Chemomab Therapeutics Ltd.

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Operator

Greetings and welcome to the Chemomab First Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host Barbara Lindheim, Consulting Vice President, Strategic Communications for Chemomab. begin. may you you, Thank

Barbara Lindheim

Dale Welcome Co-Founder Vice to you President conference Thank CMO; Adi Operating today XXXX Strategic Don Dr. and Marvin, and CFO, Chief Dr. Chemomab attending. I'm David Scientific Therapeutics Chief Officer. are me for With Vice and at first-quarter our Barbara Chairman Communications CEO; and Executive call. Officer, Chemomab. the our Pfost, President; Lindheim, and interim Mor, Consulting Weiner,

our operate. please uncertainties take which morning, Before made subject words actual of differ call by are encouraged turning not this more discussion our our results are other on our and place to statements. statements that should factors Dale, assumptions, may will, could management's press statements, and the statements. release SEC based business forward-looking expressions. forward-looking These earnings forward-looking to words could, environment to undue Listeners expressed risks cause on together from or about to call and on expectations, may and filings which call. in complete statements those materially cause our differ note for actual forward-looking reliance today's implied Today's implied intend, that that a may, similar over our could materially the to forward-looking in with of and results identified from are issued or we we statements plan, expect, those such expressed review contain as today current beliefs All and be

Chemomab our or any with future in to of we undertake reports statements under other heading Form changing Laws, circumstances, under together similar as not headings Except Risk the list publicly materials date revise or comprehensive a Annual of factors can You forward-looking factors those for and with the XX-K, events, Securities result new does to information, the Factors subsequent any on in update by made Federal SEC. Report as filed and required a other contained reason. read

the me Dale. turn now Let call to over

Dale Pfost

refining Chemomab to quarter just the making progress conference we pleased since been call I'm report revisions to Welcome covering XXXX. the we the been our outlined March. that clinical of fibrosis in that program CCLXX, last first-in-class two and good have It's CM-XXX call conference a and is the in months first and soluble monoclonal implicated implementing to a protein that neutralizes in CM-XXX inflammation. antibody both

PSC, SSC, CM-XXX potential mechanisms We fibrosis where the of rare or as indications systemic sclerosis, be could are confluence cholangitis, as valuable. disease developing or evaluating well primary the action at currently its and for inflammation other of multiple sclerosing of and indications clinical

Weiner, several notable CMO, progress Development in to and pivotal Jack's working is position. drug We our to have bringing a is clinical States. Jack have members of first who including development important staff with this of than knowledge Clinical will tremendous delighted both and quarter. proving based US Jack the will objectives named our existing David knowledge team, years on clinical the someone in Jack, clinical the deep a Israel Operations. development more us our Global is clinical XX in be advancing diverse Our hands-on experience. and There are bringing trial playing team of areas more say interim is he additional trial expertise invaluable, United in operations we on role essential in clinical are Vice with shortly. already with in our clinical to Lawler, developments of President addition his

highly sclerosis as scientific patient potential International presented preclinical CM-XXX for inflammation, CSO, a Adi fibrosis, Dr. two Conference with presented correlated from systemic and Israel, quarter, meetings, CM-XXX, a systemic that Rheumatology we and from the of target data fibrotic our Data data in sclerosis expressed disease fibrosis. CCLXX CCLXX, to profoundly the samples damage. also skin and with levels experimental on protein, systemic endothelial at in the markers to model the During samples possible well-established sclerosis soluble reduced progression the and demonstrated impact Mor is in CM-XXX treatment at healthy patients individuals. lung compared

CCLXX Sclerosis Professor, and presented opinion by key prognosis collaborator University of worst CM-XXX as reflected the respected Leeds deterioration in important evidence sclerosis, CM-XXX serum of systemic that overtime. and that systemic be with Furthermore, Our activity for demonstrating is data sclerosis, progressive optimism CCLXX target role These lung scleroderma Annual high levels sclerosis. scientific have contribute our The levels a that at serum supports sclerosis of addressing data lethal This the in therapies. high effective were currently these Xth data at that provides novel an and new Francesco patients, systemic Systemic disease the could CM-XXX Del fibrotic correlated to biological World lacks for a a as target treatment of CCLXX. disease additional elevated biological leader Congress. the function Galdo, activity systemic of a valuable patients therapy

Fitzgerald quarter, the also in Oppenheimer Healthcare Rare the Conference Orphan participated Disease During and Annual Cantor we the Summit.

optimize first, second, development are to clinical Weiner, program maximizing clinical that team support obtained our Recall, CM-XXX advancing by advancement program the data to Dr. development decreasing turn it is in David clinical we risk, decision-making development trials. for leading our over as CM-XXX. for focus to plan facilitate and and registration clinical on me let our aims Now who overall clinical the overall to the David?

David Weiner

morning. Good

near final enrollment end clinical and safety our patients of expected the PSC elements PK important program: completing adds proof an this for One, biomarker our a key study to our with expanding three, effort Let clinical readouts three taking by sclerosis; systemic CM-XXX year. in recall me trial in of clinical dose-finding fibrosis And NASH the establishing that enlarged concept liver biological Two, moment in and of CM-XXX in with development component; start an

with readout are this a we in now on Let action, tolerability that me The CM-XXX's this trial. to data providing quarter. data and will in report for readout I'm begin insight pleased in study liver anti-inflammatory complete the safety CM-XXX data fibrosis and target data enrollment and development study future to the patient fourth into disease. additional activity the is on mechanism in support deeper of liver and include anti-fibrotic of final

safety tolerability pharmacokinetics needed step key data the our objective of the providing purpose, and to of early be to study should explore our Additionally, achieve exposure in this we of current assess a this subcutaneous formulation formulation drug sufficient next believe this and study to the subcu with achieved of was and development us the completion CM-XXX. the

we patients, dosing trial Turning to is trial of sites. the clinical are recruiting number the currently expanding PSC, and and

We Germany. sites have recruitment Israel, UK, ongoing patients of in at new in the clinical and

sites patient of Spain before to enrolling that start expected and the second sites open shortly additional and these clinical the US we the actively are and New enrollment anticipate end quarter. patients in will be

data revised study study design in select PSC, will to trials. the dose the the to dose-finding optimal stage we Regarding we have for later the that additional to be ensure needed adding cohorts

open cohort begin expect able to enrollment cohort in later early anticipate patient a XXXX. to the higher and dose We to in this lower dose enrolling patients being year

treatment durability extension safety, longer the tolerability, we trial, to to effect evaluate Finally, of are the open an and CM-XXX label also over durations. of adding

interim of variability QX also this performing analysis the and kilogram assess to biochemistry the The in currently the per year. weekly we study serum cohort As biomarkers readout milligrams the first, XX planned clinical the sample analysis the evaluate dose this in of CM-XXX with administration the dose observed of order will enrolling milligrams of of we kilogram. to noted, support in the of cohorts. purpose expected of be to advancement CM-XXX be interim per half in higher confirm PSC safety dose planned an the an second XX sizes second, to for And to will

Turning systemic to trial. X Phase our sclerosis

in concept this and establishing discussed disease. focusing for trial are this proof goals complex March, the our call we As in of towards we biological clinical on

of of and pathophysiology, broad provide trial tissues the in leverages activity X involved details Our additional range therapeutic CM-XXX. Phase to on the organs SSc

more SSc in of selection data to about activity concept patients. make modifying This patient importantly to to strategies, and designed stratification informed the information study trials CM-XXX's well in vascular the expedited as additional enable We to expect decisions and us our on is of to pathophysiology being revised lung, provide an skin, path enable trial subsequent systemic the design sclerosis. optimize SSc, specific in seen proof to endpoints as in for

end We are of assistance opinion on with field the trial trial this actively this in by to launch track are year. engaged designing of the and the key currently leaders in the

towards the design broader development In study complex be PSC we're providing details systemic obtaining I'm components, dose-response that will this the good to on a disorder and making as aspects relationship CM-XXX proof further SSc report pleased data subcutaneous inform higher doses tolerability support data that, call Don? Officer, a Officer, Chief to and as turn With and Chief formulation. over evaluation development in the to to Financial steps CM-XXX, Marvin, of data will inflammatory the inform and on fibrotic with President. progress next clinically sclerosis, concept I Vice Executive well safety of on of vascular relevant relevant the the of summary, Don We to our of program, summer. Operating

Don Marvin

Good day.

opportunities advancing we to a attractive capital Chemomab, opportunity CM-XXX, want ecosystem to on focusing The managing that optimal as Today, a path directly Please and we of we first the forward. not the As extent our job detail. while as that the distracted successful to do our and XXXX strive in communicate our conserving we stakeholders. market other programs performance. will bring are for finances, are financial for do tracking while are assets what shareholders to ensure We build I'm need the to we on have can we these quarter with more in-house highlights prudently competitive biotech this that, stocks additional this change delivering optimal press company, release pursuing so to I I issued from very that for remains monitoring to potential challenges. will to we our and we and to Chemomab, clinical morning and reiterate believe fashion going feasible, review challenging. doing for for cannot good development is of our CFO possible, ensure markets, pleased for see

share increase clinical quarter quarter for to $XX.X ended $X.X equivalents, basic $X.XX of for were XXXX. XXXX. March per XXXX, which million million of includes programs compared The in outstanding, respectively. were XX, XXXX, $X.X ended partly the cash compared for performance loss the was and The ADSs additions XXX,XXX,XXX the a XXXX. $XX.X quarter at to XXX,XXX,XXX, of first CM-XXX. financial our the payment. and first in reflects to ended ADSs XX, XX, XXXX. the million for now compared which X,XXX,XXX XXXX. quarters and $X.X note compensation weighted share to million or same quarter Cash, ended loss expenses loss diluted as ramp-up were reflects XX, well for management me the diluted quarter XX,XXX,XXX XX, average quarter Aviv G&A as compared the upgrades March activities partly summary net the G&A R&D stock-based same XXXX, R&D our expenses senior March for the $X.XX in and equals million share in and the year-over-year a for and deposits quarter quarter March net March as bank of equals Let for March Net XXXX, a XX, were XXXX in expense million December diluted, number our per The figure to XX, ordinary a supporting million million $X.X of that in basic Tel XXXX noncash the $X.X team or of of $XXX,XXX first in $X.X XXXX, Please shares cash to the facilities. increase basic

a which in our indicated last and cash our than to from million now runway through a time. the We of facility. ATM renewal previous our to to last housekeeping ATM about of on Dale. continue our call, cap be six plan your $XX not original back continued currently million, draw call matter with invite like the facility Cantor to of you We prudent guidance last financial directly. I And our this Last with the months longer do facility will existing is in end month, XXXX the you to this as and prudently at appreciate Dale? the consider our I to $XX cap manage year. reach turn if communicate out we Fitzgerald, we current reduction us a with We to would renewed expect support.

Dale Pfost

doing a forward ready with in indications few months details in to variety your unmet and and high We remain believe and a the the and a commercial right job the potential. of open progress is Chemomab. inflammation in we our our to outstanding excited to building plans and CM-XXX now of product to are implementing prudent appreciate with act I our look outlined today. We floor of Operator, that strengthen as programs about is its the and ability believe we've need strong to continued more and sharing path an on team confluence with implicated we're next the company. see true you value support. practical achievable developing pipeline at and We clinical fibrosis questions. We

Operator

be you. Our Fitzgerald. with session. Kluska question Kristen the Please question-and-answer first we Instructions] proceed a [Operator Thank question. comes At line time with will from conduction of your this Cantor

Kristen Kluska

good afternoon for Hi, Thanks morning and taking my good questions. everybody.

first in the program that given more these was big have with for their a I companies The of picture tougher question been past of had hurdle drugs. some other for your traditionally one

point one do readouts context So we've And and failed you the the to these is to you versus that together that component do approaches what this seen just able provide some mechanism then really a indications only impact degree thesis. role that going and not to of and more your other? early some inflammation around fibrosis help the of play in guided are think believe

Dale Pfost

Thank you, Kristen.

Adi answer able to be think I will Mor, that question.

Adi Mor

Kristen Hi, question. you thank and Yeah. the for

[indiscernible] (ph) complex with sclerosis CM-XXX, involving obtained and you're inflammation inhibiting So, by enabling for cholangitis inflammation vascular its already yes, diseases we over primary robust interfere believe inhibiting fibrosis, other that processes data to interfering the we that systemic by years are to with and the the clinical essential initial involved. fibrosis pathologies are sclerosing right. and it Those that [MRI] added systemic Type on based And support primary that cholangitis are the disease, clinical that even sclerosing relevant sclerosis. angle those with for X immunity cholangitis fibrosis or pelifiration fibrosis very in also activation like is but unique

the in either from those definitely be those other drivers those were that So way to combined in indications all CM-XXX of and differentiate efficient of tested paved for CM-XXX indications.

question. for second As your

chances initial exactly is CM-XXX these going this in conduct success CM-XXX to will study the systemic the example, registration gain why trial systemic significantly concept a mechanism design in the sclerosis the the on So that clinical for trials will we're to registrational be allow we for to of of MLA sclerosis, some -- essence of this proof us than for regards and increase way specifically. with to to

Kristen Kluska

potential safety, to able at of expect looking that. this to frame expectations signals to both dose speak to exactly point at are the sample be really higher. cohorts, help to for you for the clinical follow-up you and other that are appreciate Thanks. assess from these to know some readout. largely I I and the it's to the the us biomarkers you period? going the And PSC Okay. or understand you're looking And do be but efficacy help for different and lower the going this sizes the can dose what you then

Dale Pfost

Okay.

be Weiner, able I to Medical answer Interim think Dave Officer our Chief will that.

David Weiner

us XX Yes, kilogram safety gather The the that of data cohort. primarily so. milligram the per happy is we've the do accrued to on interim purpose for to

safety per the groups kg. support liver data advancement to data of is that higher trial mgs our that dose being In to XX fibrosis addition will from derived and

purpose going and interim primary dosing the is cohort paradigm enable for to that forward. So the

we noted purpose some us sizes signal detect including and the on and a As trial, and group phosphatase the there -- to to key of planning that are whether look related to sufficient the alkaline you as the biomarkers measures the for fibrosis will and progresses be will completes. second be at baseline other serum trial understand the variability in some

in be will change markers. of at looking baseline We from those measures not

interim the be per patients trial term out XX accrued so near But cohort. kilogram be progresses. will limited this we to efficacy have that been of in the doing as will milligram at we analysis on number in readouts from any not So reading the the date

Kristen Kluska

part then disease. the from KOLs and holistic know you time. I you question more look at you last at considering of endpoints features is of of thank Okay, kind speaking criteria SSc. this just of me to some Could on elaborate of about really on this the just to the further other you're and

Dale Pfost

want you that to Dave, one. think take I

David Weiner

that. that experts and that we're going final do on outcomes to that next of provide in to key midst now, and with of the on August. in the apply call field happy some noted in that the We're we're Yep, design, significant the we as in refining we before, the intend process our trial to detail

Kristen Kluska

Great, so thank much, you everybody.

Dale Pfost

you. Thank

Operator

Thank you.

Our question. of Jones the Please Jeff proceed Oppenheimer. with with your comes line next question from

Jeff Jones

morning, Couple for of or Thanks questions. afternoon, the Good guys. taking question.

In terms in use when treated the many readout? long when patients to are you patients trial, you safety be of readout? expecting -- And get the been PSC that that -- you will how have those how

Dale Pfost

would like that? to Dave, you take

David Weiner

we That cut end at the readout that year date know of which data to will created in not yet, QX be the off because by the have the the Yep. done. don't be readout of for support this we determined year. will

a that been date number that we idea -- to at have have into get that as better cohort that the to we'll recruited time. exact So closer actually will

Jeff Jones

All right.

August. the of timing and you've planning you've SSc, around terms of In PSC updates mentioned summer, of sort mentioned

taking? what And that? format do around plan anticipate the is that what So you

Dale Pfost

that you to take Dave, want again.

David Weiner

relate and final design will revisions quarterly SSc the our trial PSC be -- call trial. in and details we to on for the at next August amendment significant the the will we Indeed, Yeah. core

Jeff Jones

Great.

Okay. Bio what's work coming going focus question. the guys up, that be And BD then last Conference you BD to the your some I are activities. know at doing of

Dale Pfost

Okay.

Don Marvin will that think question. I take

Don Marvin

those Yes, San of number pipeline, a acquiring licensing that also I our expand early looking we earlier, be talking following mentioned in Jeff. and partnering, discussions in possibility parties potential those to It'll the to And potential in We'll water talking number have on or be as we'll have for I think in. of other partners June. be interested a in to calls assets CM-XXX. up be interest we at obviously, assets we'll Diego other in a on lines

Jeff Jones

you. me. questions thank Great, No from more

Dale Pfost

you. Thank

Operator

you. Thank

next Our the question Aegis proceed Please with comes from Weinstein with of Nathan line your Capital. question.

Nathan Weinstein

good Hey, Dale morning. team. Chemomab and the

and start route, So, to the convenience, taking these the is dosing there in that thanks my out questions. the just fact of guess opine potential that subcu importance can in the you light PSC just of with for really SSc. there I on on route, patients for nothing dosing

Dale Pfost

would like take Dave, to you that?

David Weiner

do Yep, happy so. to

I think -- Nathan. Thanks for the question,

of of mentioned, be given patient of illnesses. able as CM-XXX will a have states, the those treatment, correct, you've barrier in are not treatments and administration You just if access the disease impact to paucity IV significant a to truly to is those one route on effective either either of

may importantly, I end may the indication develop of continue to in to quite have support that patient any though additional over we subcu formulation we add to beyond convenience go PSC us indications. critical think formulation since we for SSc. up or a But in, development the will even time by think viable subcutaneous it's we we those

Nathan Weinstein

guys runway on On items very Okay, we from it's a and the fair you. I me. it you the been OpEx, think prior XXXX. of enough. just could should of terms house some maybe the guidance looks managed like year. this you growth some cash just one in question those have versus extended detail how sequential Thank well discussed you line trend OpEx And taking follow-up expect or said in keeping to year end throughout total Maybe

Dale Pfost

will Marvin, that. Don Okay, take

Don Marvin

kick trending fourth and we US as begin trial quarter the over as we the the up to to in SSc and trial of year we year. indicated in going began the is of Spain balance off expand OpEx certainly PSC this the earlier, in our Yeah.

those of the OpEx trend . see begin year expenses you'll with up So to balance the

Nathan Weinstein

makes That Okay. sense.

So the And excited definitely thanks again the see how out of pans for rest taking to year guys. for we're you my questions.

Dale Pfost

you. Thank

Operator

comments. session. Thank you, gentlemen, Pfost, concludes to will floor Mr. any ladies question-and-answer turn our that back I and for final the

Dale Pfost

we Thank and Chemomab our Thank update This XXXX forward at updating next to concludes our on you. call. QX for you you. look

Operator

Thank you. This today's conference call. concludes

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

Chemomab Therapeutics (CMMB) 12 May 222022 Q1 Earnings call transcript