CMMB - Earnings call transcript Q4 2021 | Chemomab Therapeutics Ltd.

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Operator

Greetings. Welcome to Chemomab Fourth Quarter and Full Year 2021 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] Please note this conference is being recorded. the Relations. to turn President Lindheim, now Investor and will conference Barbara over Vice I you. Thank

may You begin.

Barbara Lindheim

for Barbara Co-Founder President, Welcome Quarter Communications Results Officer. you and and the and at Full Chemomab Interim I Weiner, to Chemomab CEO, today Year Conference Therapeutics Chemomab. With Call. are Chairman Chief President Dr. consulting Vice Lindheim, our David Mor, XXXX me Marvin, Fourth attending. of am Dale CFO, Scientific Operating Medical Dr. Officer, and Officer, Pfost, Don and Adi our Executive Chief Vice Thank Chief

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

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

turn now call Dale. me the Dale. over Let to

Dale Pfost

Also, our and pre an indications of call Co-Founder on great Welcome to CM-XXX, covering I our the board produced commercial Adi of fourth-quarter, her pipeline of confluence science. focusing planned and First update Dr. quarterly along XXXX. by the I on and of unmet with potential Chemomab activities conference medical company's product, by XXXX, that a as needs. after past inflammation area rigorous the clinical CSO, this the by the Mor, full-year, review team. translation and on fibrogenesis, careful and an our on science in for the was impressed came -clinical September, CEO

look very sclerosing I'm indication. indications also forward additional an CEO I belief and excited the antibody this with a patients, lead pre candidate, monoclonal to a and in CM-XXX XX is CM-XXX in both Our that validated clinical as Chemomab's a well has cholangitis CCLXX, and sharing studies volunteers in that future of progress now our two -clinical the bright systems. rare pharmacokinetics has as and Phase good healthy And in further to primary believe disease safety that neutralizes unique SSc, you. demonstrated been X sclerosis clinical in which two has PSC. company potential be pharmacodynamics systemic supports and target CM-XXX, or has model first-in-class Chairman. I

trial positive administrations. biomarkers. million with from pipe. reporting we Phase changes With liver safe a $XX.X announced CM-XXX NASDAQ positive progress a that be well-tolerated Key overview XXXX, in non-alcoholic Xb of patients in was In to an disease, a First, year our which Chemomab merger was accomplishments close engagement transaction, included: an Chemomab. March, in eventful for fund multiple on it's results February, and in listed and and for ADRs Fibrotic target to observed evidenced completed dose-dependent fatty

in September, the clinical in public Directors and and clinical elucidate merger adding worked formulation first tremendous liver associated partnership AGC past, to expanded received aimed GMP Chemomab the attest in and vascular a Chemomab. have exceedingly markets with CMO of Development he VP of David approval can who joined have together as In from biotechnology the Biotech large dosed Board newly with management of brings CCLXX in senior accomplished continuing and timelines, business to And I expertise the molecule feedback Jack CM-XXX, This financial the collaboration President, us further for patient developments, and at expanded to we Officer, our final our and trial in team, activities global company directors us of development researchers programs, of had that how small development David study. well. production subcutaneous including of Vice as Chief Executive for a on-boarding PSC by Operating operating with and of the programs. continues wealth CM-XXX Marvin Don authorities, on CM-XXX Lawler, key execution design, of challenging Phase COVID's an cap listing, the expanding for assessment target small In strategic trial. strategic Interim interpretation who and to is We've clinical implementation, company's them. and was of we several In an sclerosis. Don also based Clinical industry-savvy also impact at its December, our practical the Financial year, our development the Global joined the brings Weiner first clinical to aims clinical II from of review the Dr. In of Leeds operations, in we bringing partnership recent IND, and a regulatory biomarker new April, a role part start our important fibrosis the batches June, Phase development November, We're in of X to our clinical December. its U.S. damage undertaken was As fresh the manufacturing is best at expanded public on and Biologics achieve go executive to recently I well-versed Officer. experience. CM-XXX's the senior fortunate optimization perspectives In he recruitment and University expertise. joined systemic with companies. Chief review announced FDA

knowledgeable clinical critical advancement potentially data sooner development facilitate to overall indications in to trials where to the as X. believe short, development clinical strong. have current few excited trials to rationale per and important minutes. we're obtained and our and and generating it to to enlarge efficiently. to these an we on in aim our three come to decreasing clinical that few clinically the systemic X. to advance a sclerosis PSC, this directors reviewers clinical optimizing There and then CM-XXX validation plan share keystone to in In programs dose the CM-XXX. research clinical aims major want risks today. registrational clinical within improvements: decision-making, to our important first adds registrational the overall quickly achieve I'll in of prepared support and by Our to pharmacological clinical optimize recommended a as CM-XXX is PSC are Expanding Maximizing We give who with brief for the and CM-XXX additional included points. scientific overview an finding the Dave you good program. teams the Chemomab is commitment for modifications a news component. trial will going I'm expand The biological well and and back information

on our with the benefit the call the over are previously generating CM-XXX indication. clinical clinical next requirements, in the runway few our now more call David in next safety rationale end likely biomarker fibrosis achieve in down XXXX. clinical three of sclerosis extending help designed efforts readouts clinical intend final drive our and I Weiner, clinical Dr. of significant program months. clinical more background provide XXXX that revised rapidly and they One this Dave. details enrollment who months, next informative capital to four we aims clinical more or expected the earlier in end cash establishing more in this the We two to programs, quarter will biological the is and readouts XX to steps provide to proof-of-concept liver the the revisions We I while provide first systemic the decreasing estimate will to readouts by changes. through anticipate May. planned. study, PK Focusing earnings these on data about X. of And the the compared year. that turn about clinical importantly, six months, they our will Winding near around over on data outlined, will for

David Weiner

As relevant the multiple outlines regulatory feedback Dale plan. presenting key CM-XXX of factors, notably has strategic from to authorities. We number on development I Today, a noted, the most resulted broad receipt important based clinical the changes this upon in revised initiated of the of review review am program. global

XX and biomarker significantly every CM-XXX a sclerosing kilogram intravenously significantly per revised weeks. XX the and the our primary more of program phase administered over three importantly, detail migs tolerability, development months finding the clinical by activity for trial two to expect exploring provide cholangitis. component program clinical several implementing of currently We We're safety, the of to CM-XXX Key in elements include weeks, dose expanding time.

including evaluate of both this of be ongoing cohorts, and the in the additional dose We adding size higher to will trial. a plans CM-XXX study increasing dose lower by level a

durability to longer safety, extension of over trial plan add open-label tolerability, and the to evaluate we addition, to the durations. effect, an treatment In

dose year. an will the with safety assess data, the be of performing biomarker enrolling expected currently in interim second half study an we in the in cohort of this analysis to Finally, readout

biological Focus Regarding our systemic establishing patient goals the sclerosis systemic of trial, and population. towards proof-of-concept clinical in this sclerosis.

trial, planned registrational We different seen of of in and trials. CM-XXX by enable further patients. damage are primary provide informed endpoints sclerosis of enabling expedited way patients long action sclerosis skin in The treating should the mechanisms forward path a as and rapid route of revising systemic study from our the for in an a can to well clinical data, more about as vascular that decisions the clear design elucidation systemic of obtained selection and data potentially the this proof-of-concept

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five a for down we will and primary CM-XXX per safety, sclerosis, dose cholangitis systemic subcutaneous up in trial our ramp that is winding patients. we as evaluating indications tolerability, our be and ongoing liver of Lastly, milligram activities sclerosing formulation primary of our kilogram the fibrosis of biomarker

data We enrolled will the required be we enrollment visits, tolerability CM-XXX timing on and of all support and insight in study data around into mechanism all readout of complete And be coming safety year. and to and readouts of patients development, halting - weeks. study action. in on will include end diseases. deeper anti-inflammatory this the additional will to screening the anticipate CM-XXX's clinical the activity The in final based data liver the this anti for future fibrotic Providing

turn To in the CM-XXX are to of clinical on the data obtain to are identify the To the achieve optimal to is objective development early to exposures to next of development drug cholangitis. formulation. primary aspects for to believe sclerosis, completion sclerosing with obtain dose the Finally, we clinically the on data key this And development later relevant relationships study purpose, formulation in subcutaneous data important explore expected of inform CM-XXX. the rheumatologic to and supportive dose the proposed in And the assess associated study this safety systemic this sub-Q data. The if broader in steps trials provide a advance Marvin, be doses providing changes needed components. primary of novel meaningful a particularly To key program development to our our of subcutaneous Officer, of sufficient on following the also pharmacokinetic best proof-of-concept benefits, as to program. should focus response in data timeline, our data clinical the rare complex and in of sclerosis. provide Accelerate on efforts like the including the therapeutic should and sclerosis, first-in-class systemic Chief as proof-of-concept clinical Don our disorder diseases will to these President. the sharpening CM-XXX, Don? our Executive the Officer, inflammatory additional next relevant safety to sclerosing evaluation over the and mechanistic, with the informed support And With formulation. to tolerability well changes both I Operating biological, a call systemic Overall, Vice obtain Chief data. and achievement the higher path for informed steps of that, and Fibrotic the development cholangitis the of CM-XXX. Financial

Donald Marvin

day. Good

communicate As see will stakeholders. Chemomab, opportunity I this for to more financial outlook pleased our of XXXX. review issued directly the I Please about thoughts performance. the our Today, morning CFO detail. press of financial will other discuss have with this shareholders XXXX we I am for and release highlights our company's also briefly to

how place Our time tough you, first-ever can in have been industry. they is quarterly and I cycles challenging during a Like through painful the taking many particularly conference call be. before, market know biotech of

to that change And but are what we extent fashion from programs assets the ensure to times. achieved However, cannot prudently this conserving we our is pursuing I are CM-XXX, to ROI that attractive possible, not the the on build and capital clinical feasible downcycle's too. I one investments, for the ecosystem need do, optimal believe markets, for successful on bring our also opportunities house. know will monitoring have to plan a company. as while potential can cycle Chemomab as And We optimal greatest to ensure our advancing we distracted in managing in additional that to our management, we focusing to better development finances, inevitably for

performance summary Let me of now financial XXXX. a our share in

loss $XX.X loss year to share diluted XXst, and in XXXX. also basic the million, in or the XXXX, and of or $XXX,XXX,XXX quarter net and quarter as share net diluted $X and XX, expect $X.XX XXXX for year a and and for for year XXXX. million million December per a and full the quarter expenses Net for XXst, ended in XXst, million million basic of ended net for XXst, ended diluted compared to share $X.XX weighted million XXXX, of same the loss diluted the $X.X or $XXX,XXX,XXX Cash end a million ended were December and filing year ordinary quarter basic be or $X.X December same $X.XX compared per $X.X of cash net addition The and for December for $X.X loss we was G&A In million included and March. $X.X fourth outstanding, of for press XXst, for and compared December $XX.X XXst, quarter diluted, today's million $X.X for number as and XX-K December year expenses the XXXX. $X.X $X.X the were $X.XX average million and XXXX. million share $X.X before shares loss year to ended release, and the the our of to the basic detail full XXXX, December million Report Annual year XXst, of to equivalents XXXX, December basic $X respectively. for a and the $XX.X million to full are compared the the quarter R&D for were XXXX, million per of and

As Dale be implement and coming program to efforts of a Dave our over months, CM-XXX. cornerstone our for described, revisions will clinical the to

costs, less sooner of area work our by a of risks the characterized expect are the and CM-XXX original along as noted, we programs, to more continuing have providing of And we better these noted, its that and have Chemomab more and operations. achieve while data us readouts changes Since effect per in with inception, trials. upholding been strengthen to the our sufficient are we capital. that report beneficial to less And clinical us efficiently subsequent validation costing we the changes plans. may I'm to use smarter implementing tradition ensuring positioning at allow are has we by every pleased registrational As also less clinical than way of

of have prudent prior to six end to for expect management corporate forecast. clinical in that pleased than through spend result longer our is savings, capital confirm resources, now adequate and of to expected a the our company This I XXXX. As sustain plans continued the we about these am of months

required greater good is it us raise downturn market being during a thing, Now, to flexibility. funds provides new

and Another and important corporate initiative and for investor educate and XXXX is our our communication extending stakeholders enhancing about of to clinical outreach better programs. the our various potential inform progress

we'll company. round special We story corporate excited our as planning We work and invite if by events, going valuable In XXXX and Chemomab our and to CM-XXX compelling is at opportunity and in-person and in reach tell investor vibrant rest like a are summary, ensure widely revised and momentum communicate strong of continuing lives updating clinical more a investor of an to investor to forward. have your have a call continuing the potential conferences, Dale? build Dale. to out difference about patients roadshows, back and development would and I known are into turn make and now non-deal the and appropriate. other therapeutic are activities appreciated to We you We significant active believe program to we XXXX. social will support, outreach, to we refreshing we while with over us the virtual achieve you afforded believe media that appreciate materials directly. KOL the to opportunities of the

Dale Pfost

our confluence potential of with potential. you sharing you we need to of our achievable revised unmet new team as outlined prudent on to in We indications generate and for to medical trials, program informative positioned registrational of high strong programs. its believe believe clinical that the with path variety to commercial practical our a few implicated and and We capital. more pipeline milestones great is a inflammation in more preserving achieve your strengthen with details and our value months, building expect support. months. XX it potential has look an a we job Fibrosis forward With plan ability be programs over Chemomab. and clinical We act and plans while has outstanding product We are to right today. CM-XXX we to: about for the see continued done are better catalysts, the revised clinical I developing thank excited next the at next this and of And

Barbara Lindheim

This ready for Operator, Thank our questions. remarks. we concludes prepared are you, Dale.

Operator

[Operator line will the Instructions] confirmation tone and follow-up then and Instructions] Please A queue. indicate one [Operator in question for your questions. is ask question additional question, one re-queue

Our proceed. from with Kristen Kluska is first Fitzgerald. Please question Cantor

Kristen Kluska

these good and taking at wanting systemic question. comment patients. a I could morning more afternoon, to role a organs could the the Thanks on considering differ Good look of to I my holistic Hi. point. understand that of But everybody. all effects endpoints for for the wanted on ask; on some They're package trial based design you implementations you this on sclerosis. of some different play you're further at

example, this exclusion, inclusion, across length criteria of of time, at levels to severity, it to well at as point? study changes is of different understand above For different at as you the or are looking all doses looking or

David Weiner

above the It's Yes. this of point. Hi. all at

a more intend in so intend very the we're individual rather -- CM-XXX exactly heterogeneous to has focusing than we're going explore in each components exploratory to provide And trying We We a composite design. proof-of-concept. in disease a that more of months. components, and moving more the of goals clinical that. on what we multiple to an in do in address to those unique revised endpoint, this to And achieve SSc. opportunity And design believe initially a have trial on we're clarity towards we coming changed deeply

Kristen Kluska

enough Okay. you of understand on is this Thanks you then that. formulation. there decision, second to study? evidence sounds question the the and that Got this my subcutaneous final think definitive type It based for it. at for off And with is, is this least like effects that

the and can result, out you SSc moving into assuming that trial? after And studies things to then these you're consider is So happy the confirm subcutaneous initial plan then a PSC with that? positively, just read

Dale Pfost

Yes.

we what We or that explore are subcu is formulation, indeed goal the readout next And our data continuing conducted being program this formulation be from exposure optimizing get liver thereafter. such, the usable trial to programs are. to when which soon the of And the steps later clinical with non-clinical that and the advance aspects that in here the pharmacokinetic fibrosis the our in trial, will is is year, the and either that determine it'll registration them.

Kristen Kluska

my for Thanks questions. it. taking much Got so

Dale Pfost

you. Thank

Operator

[Operator Instructions].

next is Capital. Nathan Aegis question with Our proceed. Please from Weinstein

Nathan Weinstein

on Thank higher confidence And dose. Chemomab team. the you. Good taking the morning, much including for include a Dale, you questions. the one is Adi, just my dose so higher trial? and to first in revised regarding What Thanks PSC gives the

Dale Pfost

to observed safety all us the will in -- future. is trial to I'm of good, to mg the believe across dosing that than we quite sure dose. [Indiscernible]. a targeting but we near the date more single-dose the explore evaluation populations, dose not which We have rationale with kg add our a higher desire per in PSC -- exactly XX to The lower confidence, that the currently is the XX the support we're here is CM-XXX that advancing and the

Nathan Weinstein

or hoping runway, of guess indications? extended And conceivably, does secondly, least then what was both that us hear cash prospective of the to I registration Okay. study appreciate through That's exactly with in so that. initiation one the take I at a I the

Donald Marvin

As the sufficient run we've the through cash have XXXX. before, stated operations of we to end

will investigating that and more as months. trials designs team further communicate investment we'll the to maybe the over be next become that couple We formative,

Nathan Weinstein

Okay.

Okay. for my Appreciate it. questions. Fantastic. again Thanks taking

Donald Marvin

Thank you.

Operator

[Operator Instructions].

final to no comments. management any I closing this questions at There turn to like time. would for poll for conference over more the to moment brief questions. a for pause will We are back

Dale Pfost

over in the you. to clinical about to excited earnings Well, attending real to We're proud looking you our our to plans. thank the the quarterly that potential. months I'm last you couple call. forward their and really for they've quarterly of Thank undertaken these conference of the again updating come I'm much May first very adjustments call. team, processes

Operator

Thank today's conference. conclude you. does This

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

Chemomab Therapeutics (CMMB) 9 Mar 222021 Q4 Earnings call transcript