CWBR - Earnings call transcript Q3 2021

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon. My name is Chuck, and I will be your conference operator today. At this time, I would like to welcome everyone to CohBar’s Third Quarter 2021 Financial Results Conference Call. All lines have been placed on mute to eliminate background noise. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. this being note Please Instructions] event recorded. is [Operator turn over to would now conference to like I Ms. the Tarazi, Jordyn Director of CohBar. at Investor Relations Please go ahead.

Jordyn Tarazi

third Thank for conference thank and quarter CohBar’s call. you, results XXXX you, financial Chuck, joining everyone,

and followed me by results Chief Officer; CohBar’s may issued press Officer; provide Jeff release from Ken Joe introduction Financial begin Chief website with from today cohbar.com. program Scientific Executive Biunno, at Chief was an on CohBar’s today’s the CohBar’s Officer. third Joining then will update is and be quarter Joe Sarret, an call Ken. financial downloaded Cundy, CohBar’s our of earlier will CBXXXX-X on results. an Jeff overview financial

We will conclude Q&A. with

business remind financial therapeutic for include our the and the our call limited and and laws. and financial regarding operating the data, are updates to candidate trials about relating and activities resources, and pipeline Before program and FDA's company's orange of its clinical related today’s research conference to product commercial Statements program, and and to, statements trials ability on forward-looking and These mitochondria-based listeners and therapeutics, candidates product expectations book. the and but pipeline and that partnerships planned our statements patent potential of patent ongoing its regulatory the its fund other we a performance like provide development forward-looking timing moment the and CBXXXX candidate begin, the and the I’d ongoing announcements planned the the may strategies, ability remarks of CBXXXX, protection lead operations. not of status for potential statements including to CBXXXX potential lifting clinical including the capital to regarding including company’s within meaning company’s take include, lead drug candidates securities statements strategies, to a and plans and

reports materially and projections statements, These number and on uncertainties by statements cause risks and current at well which and and Exchange Canadian our could Securities Forward-looking Harbor available regulators, interpretations website those registration applicable sec.gov a securities expectations, that are release. with cohbar.com, uncertainties today’s in of Safe differ a as CohBar. with on that based sedar.com and other Commission our are at than to anticipated involve statement described results in filings are the risks and press as actual included

are statements. forth actual obligation of differ events not You that information any a are CohBar future statements forward-looking or our or publicly new information, may guarantees performance or statements not in results the undertake does cautioned forward-looking set revise result otherwise. whether those as from that and update any such of future materially to

Joe? Chief Officer. Now to Sarret, call over turn I would like CohBar's to Executive Joe the

Joe Sarret

you, Thank study. us of made advancements you, Jordyn, last data human first readout areas afternoon. The our achievement was major positive thank the across quarter this joining everyone, for eventful. from CohBar of We significant for business, and the including our milestone a many quite

We also capital. human our strengthened

relevant Carol CohBar. wealth CohBar the part and members, Yun. Welcome Dr. board Nast a addition They and team. new the With and Joanne Carol each as of industry fortunate two are bring of them have of to Joanne to we expertise,

broader a also pathways. play genome regulation a peptide mitochondrial production, develop to the story believe what In and for excited better, of biological addition, in power to continue we novel variety think energy that terms although the of tend of the people our our us recently and advance fundamentals completed ahead. role have CohBar therapeutics, mitochondria to of primarily that operational harnessing allows been to the a much never extends We of is in leader our financing in runway lies pipeline. of a we're they

impacts has of We part and the or genome organs treatment enter power tissues. have process, encoded systemic physicians mitochondria the dramatically are the the important of this options to other provide circulation, potential of believe tapping cell they into the peptides secreted in many of tremendous improve for on outside mitochondrial and new valuable that our of the the and patients. of the approach lives As

which Our each NASH is more controlled the variety diseases, are of steatohepatitis our with potential phase need. top discuss with background, fibrotic has our as to as an fibrosis focused In pipeline development advanced treat CBXXXX. I'd data we nonalcoholic double well chronic Xa/Xb in conditions for medical on significant of the and line or of programs indication we initial under obesity, most treatment of like And unmet CBXXXX-X a programs believe randomized placebo that positive of from August, trial multi idiopathic detail. or to blind With these centered IPF. pulmonary CBXXXX, announced

Xb in during the it's takeaways While the results I our last worth portion detail study. the we of key review from quarterly reiterating the call, think

fewer this important a drug injection it of candidates of This off primary met with reactions. from is adverse profile target events also an non subject for analogs First, that program, validation occurring peptides naturally broader than hypothesis only tolerability in natural mitochondrial group, but CBXXXX the will endpoints developed effects than outcome of not and sources. derisking its our have than clean other safety study transient site occurring the tolerability, one more no in is

liver longer of and potential compared versus but four in when also key with to health. compared seen biomarkers Reductions weeks only terms inflammation subjects treated from of saw ALT assets placebo, NASH and which CDXXXX of placebo. compared reflective compares improvements phase development of markers in in time studies significant with are AST similar reduction ALT in points studies improved other for both products, to of liver we favorably these not to liver efficacy, damage The NASH. treatment currently In CBXXXX are XX% in decreased robust and in three

NASH encouraging that result CBXXXX with level reached resolution; the reduction the treated fact, four seen in weeks a potential ALT very In just CBXXXX. with had subjects of level reduction a of after of predictive treatment of of XX% is

XX Even of compared that only one preclinical our We with though result glucose of approved in a fact that the this demonstrated combined NASH believe have the placebo. as data particularly CBXXXX patients also is was in promising diabetes decrease XX% insulin the comorbidity. subjects light We significant a trial on the in diabetic. in signaling to group almost of

with treated weight subjects Additionally, towards CBXXXX a reduction. exhibited trend

liver were fat decreasing and the in the provided reversing We were in that diseases The additional inflammation presentation two Keep the fat than announced the selected data itself study. in fat the that for demonstrated NASH poster at fat liver between a arm results, the markers leaders and of poster subjects they the the substantial prior on the despite or damage CBXXXX ultimate eating NASH liver breaker we fact a in placebo fibrosis, the groups. one the lead only reductions active not were for the patients. the poster the we a and were context mind placebo we provided Notably, Rohit metabolism Loomba, group mentioned of which liver leading Finally, these in in of the key similar Dr. late the healthier liver field, the confined and enrolling liver reduction saw to last that content is the due and level earlier. believe inflammation improvements similar groups, of that to glucose is in both was trial, After duration in liver of in reductions to American diet the treating AASLD, related study. and I and author for of Study Association was slowing for objective in of held week. opinion and

In further issuance would program in generic prosecution barrier NASH. are for foundational the U.S. U.S., Book, the multiple patent of September currently of to methods counterparts therapeutic use, matter be foreign in to world. are Patent, countries There on to Orange term that which momentum additional new and throughout at stage as our FDA peptides, the IP as in entry. is new Finally, this a our the front in as the is covering patent the CBXXXX a XXXX. CBXXXX use of treat of patent least to due including of important this an gains The peptide of extends the eligible the well event related listing in the also approved patent the composition

to most such with setting experts phase reflect that CBXXXX other in an We've formulation of these that patients developments on key and the and a to work appropriate that NASH NASH. Taken advancement study we preparatory has a additional in have demonstrate design treatment significant great a program. leaders opinion before determine shows believe begin. with outpatient in together, duration impact could and study promise do longer Xa the for We the results meeting been clearly our disease meaningful study

NASH, opportunity to of with market Given million forward and the long of of it's with impact timelines represents associated program large our we to the treatment context dollars. and recent potential expense large billions in a and data size XX have with preferred U.S. in of very a the assets been the the be for CohBar path NASH partners. XXs in with would our discussing potential up partnership, estimated clinical developing people alone, the this for

agonists. use is developing clinical disease. synergistic cough, potential unknown generally a due a to-date, NASH in is and While disease that many age combination XX, which commonplace become demonstrated respiratory and including second no of to candidate, IPF. a anti fatigue. adults approved with progressive it's of expect classes is well-positioned models common of effects complexity preclinical IPF drugs, for due we our action more anti been We to drugs turn GLPX unique in include its in men. breath combination CBXXXX symptoms inflammatory persistent initially typically to regimens like are mechanism the and peptide broad that and the Initial is therapy cause believe now CBXXXX-X impacts properties to of have likely the shortness of with the to for over of fibrotic I'd other

is most years due survival and between them two to Unlike to side are cancers. While varies approved NASH, to currently worse three tolerate course of only disease effects. gastrointestinal the there drugs many is photosensitivity unable considerably after than which IPF patients the two are that individuals, mean treat diagnosis

patients mortality. loss continue remain morbidity experience and While outcomes current to significant treatment of and function, the delay poor, can lung of some

So there the annual the has efficacy drugs need on the improved therapeutics $X market, exceeding a of with billion is and safety for profile. an sales limitations Despite currently pressing better each believe per year. to currently peptide But our moment. program we Ken will face. say IPF this that that has the CBXXXX-X more in significant the patients needs unmet address about novel potential a

sheet balance clinical continue to enable both our public added a tremendous promise candidates, needed of to recently of which the million pipeline. completed offering, our we our to much advance us Given to capital $XX

clinical novel confidence recent even CBXXXX from power approach that us data drug Our of taking positive we development. gives the more in to are the

now first combined to previous progress and initiate excited funds in balance, additional are I hand human well-positioned Ken IPF now cash year. over program, an with the With review study we our about study our update continue will Ken? will pipeline on our to regarding plans are particularly our to current potential for to the including CBXXXX-X thinking next who design. our our

Ken Cundy

Thanks, Joe.

announced these analogs family anti-fibrotic process lung in by the have that beginning week outcomes, inflammatory bleomycin secretion work lung studies vivo model inhibiting on demonstrated these had vivo analogues cells, anti clear in of FDA more of the of proteins for the to of improved in the were mouse those CBXXXX-X on has production drugs than Joe a an cells. given and anti-inflammatory levels tolerability Based approved which, study in greater in also filing improved cell inflammation. of approved human Since an effects activities selection cytokine one anti XXXX. appear candidate a IPF. the the the Once in on multiple clinical goal pharmacokinetics study collagen, IND challenging IPF. animals drugs. for the it we been an and the showed number following We've therapeutic effects would tolerability, IPF. be as necessary we've shown key we CBXXXX-X in tolerability effects fibrosis transformation an IND study properties treatment the of of potential natural of subjects. fibrotic in induction get In CBXXXX-X all animal effects fibrosis, currently safety, with from based proceed, mentioned, conducting parameters after and examine peptides and of that healthy XXXX initial Our on model, of in to to strong profile entering the by final to new models the treatment we vitro seen adults is advantage nintedanib healthy same the March, these clinic are preparation approval in with of of and positive the one reducing of and of and A peptide, have IND fibrotic in several cells reducing safety cultured involved and be conducted the poor enabling from lung the as relatively the Since peptides two our and submit have fibrotic fibrosis, will pathological to in

We day ascending and multiple given doses. subcutaneously several doses as will testing dose seven expect involve CBXXXX-X that of single

forward subjects identify will with to objective IPF. into Our dose appropriate be to take the most

Toby for disease design ways slow studies. of of and been University key to of of Dr. a the an process Mayer, IPF to initial possible patients. Now IPF Lung drugs Interstitial of and Keck we Kaminski, Yale to development at Medicine. proof and in input, medicine on area involved we be of chief the Director sleep believe and Based discuss other proof critical like it of School have They've appropriate the week studying California progression. who's conduct Disease continue understanding concept of Professor four CBXXXX-X most Naftali CBXXXX-X of path on in their Southern cutting Medicine Dr. for the are of experts School edge care of disease clear Medicine at study to with IPF the development the pulmonary of may and how They of concept IPF the its

of design type in cannot as from biomarkers potential key the as While study of biomarkers our effects FDA, under to The of discussion. related input IPF still look at study animals. in be of without concept finalized seen the this certain the proof early may well is biomarkers of CBXXXX-X details disease,

of be So subjects one IPF design. in selection single concept in potentially healthy subjects study X/Xa and phase in a sequentially could proof evaluated

We be our And call our input you from This We efficacy our is FDA nominated the protocol will program and be milestone to believe data to forward novel the look study for proposed be CBXXXX-X we second request define development for working our summary, further to to plan and design. In preclinical have on technology clinical to look promising. on that, the two the for future return with program major next progress company platform Joe. I'll it would to a programs updating year. stage on this with clinical course.

Joe Sarret

Biunno our Thanks, our now Jeff? Jeff I'd you financial quarter walk Ken. like ask through third CFO, to performance. to

Jeff Biunno

an based increase continuing and September by $X.X compared Thanks Joe, were research The of primarily administrative the $XXX,XXX. in you compared to in million I approximately in in general and $XXX,XXX. year provide a QX, approximately a in expenses based to the as million third XX,XXX expenses QX, Research period, and was with due approximately compared in for expenses an an the this million the of will stock costs in prior QX, period, to QX, administrative primarily costs. peptides, increase The $X.X XXXX compensation summary for increase our were and year $X.X higher compensation operating $X.X to quarter General in and stock due expenses expenses million development Total the development XXXX increase of us offset $X.X now increase to of in partially associated million decrease $XXX,XXX. prior was costs. thank were XXXX financial $X.X million you September of compared development to XXXX the ended results afternoon. third joining XXXX. everyone our ended XX, with quarter

ended for ended of $X.XX or Net quarter net share. the $XXX,XXX million basic and XX, loss ended September reported $X.X non-cash quarter of and XXXX or ended For September to $X.X the XXXX and of loss diluted the million approximately share, $XXX,XXX CohBar expenses XXXX compared per XX, the for a quarter a diluted $X.XX XXXX. basic for loss September XX, per XX, quarter September net included

September XX, non-cash quarter was loss to million expenses prior period. compared million the as XXXX for $X.X Excluding the the $X.X ended year CohBar's for net

XX, balance in million of of cash the to burn $XX September sheet million XXXX. million. to September XX,XXXX as had investments The December Moving CohBar $X.X compared XXXX, quarter was ended the as approximately for and $XX XX, cash

During common ATM program, quarter stock completed offering, quarter warrants operations exercises the XXXX, capital Joe. third half of based to of sales as to back public on of cash over from sufficient our XXXX. investments its and of turn the from the now and funding XXXX gross have from proceeds the $XX.X balance realized of subsequent offering, We the million and end to completed we recently estimate CohBar and public stock options. September and the XX, second I'll and And recently of Joe? into call finance its

Joe Sarret

Jeff. Thanks,

your remainder areas key take XXXX. for our highlight questions, we beginning of Before of year and I'd like the this of to focus the

to working study. for First, design also on Xa continuing are while optimize a formulation the the phase CBXXXX, we of

this In addition, in ongoing next IND initial NASH file annual will partners program focus on Other potential on for an we and major the discussions at continue NASH interest IPF. with begin track next space, year. IND who continuing month. for and to fifth to have the be Summit to We enabling advance CBXXXX-X remain a have studies clinical is the the study panel our speaking for

first KOL the human discussed, this working Ken As design study. finalize with to we are for also

never company stronger. discussions, you see from the today's the As can fundamentals been of have

drugs activity that variety power a of new the disease in been have have a and models. mitochondria broad demonstrated extraordinary of plays of role to biology in it therapeutic the potential leveraging the class We whole develop

towards and on position, novel a data that to sheet we the CBXXXX-X products clinical of believe we clinic developing expanding are strengthened positive continue progression our the CBXXXX, our recent well-positioned to balance the to of advance goal IP With clinical and have please for commitment continued can you Chuck, to-date. shareholders questions? I'd thank to support their make made progress line the which for clear enabling with the us has we like our that open benefits. instrumental in been

Operator

Yes, sir.

begin will will Please the And ahead. session. question Kluska the question Cantor come with Instructions] Kristen and We go answer from Fitzgerald. first [Operator now

Kristen Kluska

it findings a Hi, the Maybe your baseline Thanks at for breaker questions. around some you you on lot good presented? start like you taking And details late with the my through poster new provided everybody. more just AASLD, assessments. could afternoon, walk to of looks

evaluate if changes these additional curious So you how correlate treatment measures plan to to see the may effects of some some observed? the CBXXXX across with of this other post with

Joe Sarret

Ken you one? want take to that

Ken Cundy

is Ken. started had really before and This Yes respect the AASLD ASD. Sure. the with Yes. substantial in the what ALT poster with to we reiterating announced reductions

So and depth information, do we as that we a one the courses time are provided which clearly ALT of ASD decline obviously in studies. further was longer including go to expect might continuing in that something supportive there

presented longer In in poster the reduction new trends addition, the treated baseline we the the data more additional obviously baseline compared we will body when analysis weight to also and basically say glucose and update we the correlations of list The additional the have the subjects, placebo. is towards biomarker of in data the of is on the characteristics change on information to group between study. those CBXXXX about characteristics values course, the biomarkers ongoing these biomarkers this and any that. additional that evaluated across for their study There might be in a of

Kristen Kluska

the also next not related that's the effects diet And in any expect healthy were in to these from as of a arm? to separation, looking the anticipate you ahead confinement liver if potentially placebo light arms? a the at thanks. for trial be observed wanted looking is might you at ask making as you're if the to protocol Great, time to see that changes side much you're case, where longer, And if there even two studies all

Ken Cundy

is phase study following this confinement in phase using initial of site next observe formulation not embark COVID would an was two did future but do, we design the One study. to of way our any of study. improved we would be II would we to where really the had injection would we to things. the need respect This the envisage we persistent local the study, study also because of With deposition, outpatient and first the be overcome sites product injection subjects Yes. on we

Kristen Kluska

questions. thanks my for taking Okay,

Ken Cundy

Sure.

Operator

go with from next The Please Kumar question comes Capital ahead. Brookline Raja Markets.

Kumar Raja

taking for questions. Thanks my

in terms So those? with regard to by moving in the II the the yourself? phase forward with phase or And the trial II trials, for how to are what proceeding partnership you the forward of far considerations partnership are

Joe Sarret

Thanks, Kumar. Great question.

from terms just data off poster in the announced was trial we now we're coming So of presentation CBXXXX heels partnership discussions that you in of our positive about. as August, and know Ken speaking the the AASLD

with we with on IP progress So well positions parties. think front combined continue to as interested that to discussions developments the

As to you know, it's difficult sort of how predict always going to kind of are discussions take. long those

So lot that, to context more than those whole that other provide we're having it's to than hard say discussions. a

the versus of what forward a moving it's that a related versus partnering available bring, now risks the really discussions that about going, what partnership terms considerations forward are partner on how is decision terms to the complex and moving our our weighing of be might own, might in and potential of those sort again that on In own.

of the be partnership. as field, the mentioned path do equal, we of a we preferred think just being in the that in remarks, prepared As complexity the else NASH given context here a all earlier, would forward

Kumar Raja

also, where some some and GLPX. obesity and like have you also here in Okay, have and effect data synergistic seeing you're you trends NASH preclinical with

kind would get fall does of who in of in in terms be more like and of what how would obesity? potential data do a you terms of that partner kind trials some So think

Joe Sarret

Yes.

four way did trends you was noted, in currently So as a we about study. in the trial, is think XXXX reduction the weight we that just the, the see which week

a least obesity, of massive way So obesity. longer would We there figure we bodyweight body is of at this a in in NASH, would that where to how out therapy didn't sort subsequent likely hopefully better expect duration context the and of us in changes see trial changes the some be to think additional of of evaluate effects subsequent give in with of at context opportunity then duration trial sort see just to brief a the to best stage such data weight. I to think, the which pursue a

I obesity. think variety at NASH are space, that sort people different that looking a including know a is associated you a as of NASH disease with dysregulation of as metabolic

many GLPX and the are as indication we body So obesity drugs so believe as synergy potential partnerships for for market assets targeted obviously NASH people those potential that in of at and being interested that that obvious are would currently are also are on are there impacts well. potentially looking a with drugs interested NASH people in the some have weight be so agonist obesity on potential people, there and like particularly opportunities

Kumar Raja

filing be and terms in are of XXXX-X the Okay to in the IND? studies terms remain what done of

Joe Sarret

there? you comment want do to Ken,

Ken Cundy

Yes.

respect you there's an to purpose. with as aware of a construction So IND review are box of process checking FDA an from

so in goal we give midst you of be where of going think not would process. better on sense and We're parse that on individual give kind out But to the the a are next that in that. And we're to pieces. I of updates

Kumar Raja

much. so Thanks

Operator

like would Joe Sarret and any over to ahead. answer This to closing Mr. back conference for the I concludes remarks. Please turn session. question go our

Joe Sarret

please this you you us the call. We would our conclude our look joining conference for next on call? on progress forward Chuck, afternoon. updating continued you to Thank everyone

Operator

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

You may now disconnect.

CohBar (CWBR) 16 Nov 212021 Q3 Earnings call transcript