CWBR - Earnings call transcript Q2 2021

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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 Second Quarter 2021 Financial Results and Clinical Trial Update Conference Call. All participants will be in a listen-only mode. [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 Relations to I CohBar. would Tarazi, conference to like ma’am. Investor Now, Jordyn the Director go ahead, Please at of

Jordyn Tarazi

for you, joining results Thank CBXXXX conference data topline thank and you, and CohBar’s quarter XXXX Chuck, second financial call. everyone,

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

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

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

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Joe Sarret

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Ken Cundy

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please. slide Next

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please. slide, Next

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please. slide Next

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define clinical that, an Joe. Phase I with the more with disease meeting. appropriate of path area at data And development from from Additional Phase analysis data study Xa/Xb still we topline to the of this pharmacokinetic support positive and are planned study return study of work sharing will the pending. data the Xa/Xb to the the NASH from look and from to We this forward. data conclusion, to In call study most is experts CBXXXX plan the the this forward for scientific further upcoming

Joe Sarret

we’re today’s that Ken. announcement. With excited see about additional can Thanks, detail, why so you

arm the function as light mechanism the We believe in improvement approximately patients of fact it’s of co-morbidity. compared the treatment in liver the a treatment not particularly saw to treating products to the a context, cirrhosis, than to have NASH to and the comparable provides that liver in favorable robust in The NASH further value development group. in in and to insidious that with fact is studies, decreasing the longer result treatment only that seen or ALT from of markers but and first CBXXXX. week that the fat in ALT of of many liver helpful at put and four it delaying compared health liver, that competitive goal inflammation that progression in week placebo changes. liver function absolute NASH. reduction place. rationale remember patients of the liver back greater Notably, progressive is for with the we from impressive effects XX% damaging changes to liver the despite studies disease. these is was take treatment and enzymes after injury. of preventing under key most Reductions in fat glucose levels the the To for the slide. serious XX notable, and is of a The objective the distinct in This improving in Next that step consequences CBXXXX seen predictive strongly in reduction liver four the significant the injury, reduce and another diabetes treatment inflammation thereby of NASH after improvement is results in these failure fibrosis cancer. NASH have the AST in or suggests liver improvement CBXXXX the The seen also for among placebo, AST liver the weeks ultimate reduction AST levels of evidence like, with circulating is ALT

possibilities synergies diabetic was especially diabetic. While since in study, result preclinical This demonstrated GLPX such common subject and only raises as future intriguing between treatment one work agonists. CBXXXX trial for our this

that provide not CohBar’s approach. evidence from a Next encouraging of hypothesis We subjects. and peptide, results processes slide, CBXXXX confirmation overall peptides validation as for occurring peptides The tolerability have to have but beneficial clear genome now analogs in that provide analogs program, safety please. only human superior they within naturally and These relevant analog first important results of encoded that human mitochondrially data significant our also are also likely disease can encoded the these are the on profiles. mitochondrial have our of impacts an

and program, next terms recently keep line be incorporated determine received results need next In clinical these CBXXXX can to only best steps times in the the for into how mind we of our that trial. top data

helpful We We context are also study weeks. discuss data. pharmacokinetic PK and results or the out over to for potential coming the results, the which still PD the to for additional waiting reach plan may safety partners provide

formulation discussions. study. the discussed steps previously, progress and to continue also a Timing As move a new funding to studies complete and in of to activities able will refine initiate necessary the for with and forward depend we these our plan Phase the formulation on availability be clinical for the partnering CBXXXX Xa into

In potential distress potential tremendous now show a performance. Jeff to a have our peptides respiratory acute I’d to walk our Jeff. you CFO, that as and quarter to from cancer we novel the of Biunno of promise also addition ask through indications, like diseases. second IPF, pipeline including treatments financial other variety syndrome, our CBXXXX program, for

Jeff Biunno

our second June you you, quarter financial the ended XXXX, and compared Thank XXXX. this joining a the afternoon. results of now provide to second for will thank summary ended June quarter for everyone us with XX, I Joe, you XX,

expenses Next increase in our development $X,XXX,XXX. please. approximately development operating were XXXX $X,XXX,XXX. non-cash were QX, QX non-cash the the and Operating of the $X,XXX,XXX depreciation in quarter due QX compensation period, increases Those expenses total expenses June to XXXX our as General expenses, development to and were research Total and increase ended Research XX, and expenses compared costs. includes primarily for and was approximately in to D&O compared higher year Non-cash premiums. $X,XXX,XXX Net QX, XXXX XXXX, stock for compared expenses and general the amortization in insurance an $XXX,XXX administrative of and XX, slide $X,XXX,XXX included of operating $ as $X,XXX,XXX. stock-based XXXX X,XXX,XXX an $X,XXX,XXX increase were $XXX,XXX operating an QX, the compared in XXXX, in expenses XXXX. June of and expenses in ended quarter QX approximately and $X,XXX,XXX. increase in a due to The increase costs peptides year based an $X,XXX,XXX XXXX expenses prior expenses period, trial costs. compensation to administrative to of partially costs. of by were approximately $X,XXX,XXX in in and continuing of increase based decrease $X,XXX,XXX offset compensation the clinical primarily in compensation stock The prior

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

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

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

quarter sale Due sales ended timing the received during to ended end. quarter funding $XXX,XXX to subsequent of program. its the of XXXX, from was During XX, net realized its $XXX,XXX under June stock XX, the common made XXXX, CohBar quarter June ATM the the of the

of cash quarter have our as based to estimate XXXX, balance Joe? back stock operations finance to our received. XX, option proceeds sales of over into second Joe. related capital sufficient Additionally, investments and XXXX. to June on quarter that ended now of the XX, $XXX,XXX I’ll things June turn the were we subsequent We to

Joe Sarret

Jeff. Thanks,

and to out of the the like events please. some of I’d Next for slide during watch upcoming milestones and highlight now remainder beginning year to this key XXXX.

necessary results First, to of a With these plan scientific the Phase data to CBXXXX in the funding, enable to clinical results X continue parallel an plan discussions. identify the to study, any forward with and and conference to additional insights. our our formally expect move appropriate we we additional of while partnering work accelerating analysis present

to continue IPF. the for conduct studies CBXXXX-X for will Next, we our work ongoing IND-enabling

is with we programs. IND-enabling data and which to in progress to potential CBXXXX Our would began goal finally, trial have additional us in top-line Based file three plan clinical first studies, funding, to select the And candidate on from next XXXX. provide today. a IND the to announced stage an towards trial the human with clinical positive the we

convinced in the of We make a pipeline and peptide that difference the of can the are power our more than therapeutics of ever to ability approach in our patients. deliver lives real

As we and our continue to funding options that on available capital have we ensuring sufficient are evaluating us, result, advance including a focused pipeline to non-dilutive range our to the of financing opportunities.

the be CBXXXX questions, for Before you everyone opening the the to questions? would line to particularly open like up without Operator, can with thank I not involved please trial, possible. for would volunteers the study whom development drug

Operator

Yes.

first the now will go Maxim with come ahead. begin session. Please McCarthy And from question Instructions] question-and-answer We Jason [Operator the will Group.

Unidentified Analyst

would wondering duration potential on question. endpoints taking if It’s can to expect or Hi, be Thanks shed we Could on study trial expect my line we could everyone. a treatment maybe – some longer steps for a color next CBXXXX. Jason. I with for just could [indiscernible] histologic for what the we was potentially? even you a with NASH

Joe Sarret

this Thanks question. [indiscernible] for Joe. is your Hi,

that in still out here clinical us saw need to And findings to there mentioned do – earlier, some additional figuring trial. we currently we Phase up formulation, of X. the optimizing work next cetera, incorporate I the I how terms best to into that set is et As we’re that the the think for

that. working we’re So through

on forward on that little but we’ll the timing, have a look more trial details specific can have share on don’t we we specific when So updating clarity. that yet we or bit to you

Unidentified Analyst

possibly Great. wondering that mentioned one of just regarding Thanks with similar you like, to trends that then reductions potential just the AST? data range, or if correlates for more any NASH, is was color. could positive you in And histologic you AST in there had, question, of what ALT, I responses aware potentially a for to AST –

Joe Sarret

So one? take Ken, to you that want

Ken Cundy

Yes.

far well but enzymes analysis for threshold in upcoming that’s there’s the one that experts prepare we’re So be of one. different as related we’ll AST are with of that circulating not responder as may a correlation AST, disease at our scientific event. multiple to for of liver a presentation obviously And per a an specific general, area se, assessments be the as data things we potential discussing aware

Unidentified Analyst

Appreciate Okay. for color. it. additional Thanks the

Operator

The next Please Weinstein with come question Nathan ahead. will Aegis Capital. from go

Nathan Weinstein

my just see team. I there nice or any you guess questions. see the and regarding stratification fat. on based the Thanks taking in Congrats that. improvements the It’s much BMI for did so study, biomarker correlation first to liver the CohBar by Hi, Joe one on data.

Joe Sarret

you do want to… Ken,

Ken Cundy

one. This Yes, Ken. that is I’ll answer

So have additional be at the into the obvious from and subgroups analysis of to as the ongoing happen up major deep gone line What to stratification. is changes that part will first we enough that we we yet a That pick follow-up data. these. looking consider not

a that coming meeting. will the to at up see we So scientific more hopefully about be soon that upcoming in presentation tell you able we

Nathan Weinstein

you. Thank Awesome.

inform Looking trial asset the from might IPF, forward on the for that. that to that second And help CBXXXX CBXXXX you the learnings study. design of on just any

Joe Sarret

if maybe Ken, then you add take Well, first so to can more I any color. the want and

keep to action. are I programs structures thing with think different and our different that, all one so different that is mechanisms of – mind in peptides of involving

but now that mitochondrial earlier, think was we’ve validates humans, mentioning that said that that having the of in other we that naturally actually want more I as unique to Ken, But there’s peptides forward peptides think these specifics, don’t I the I sense, given say approach So programs of to and shown in if however, carry about do profile know are that they’re terms do there the the that? analogs the should all peptides. safety results think you – that, we in occurring fact

Ken Cundy

is I Yes. IPF. your from think in we learned study about, it setting, mean, question in design if what was different clinical setting of the I this

healthy for that with IPF the IPF is subjects quickly and possibilities One of readout. to biomarker a subjects start move in you

discussing we’re are But disease into, those that we’re possibility a our clearly, experts things in more with that’s in time. longer-term IPF So readouts area. IPF looking take the obviously, area the the

Nathan Weinstein

to just work with library just moving you helpful. assets of speak activity the preclinical thousand in to just a sense for the analogs, get the and the there. kind characterized in much general want how sort now That’s investigations ongoing could of I you thanks. down the guess to those have Okay, of abundant ongoing line maybe

Joe Sarret

Sure.

a So resource. I with our think small obviously limited that a company, we’re –

the most so our we’ve recently include CBXXXX more which and And fibrosis more been really efforts on advanced obviously program for the and focusing IPF broadly. CBXXXX programs,

are. where of So currently activities the those are the bulk

and time a push think those, hundred additional value of to the be do with the thereof. huge peptides additional moment, we a think future. mind in the analogs not of a resources there’s so But resource, that’s again, at additional lot I and out initial pending or

Nathan Weinstein

Thanks Fair my Okay. questions. enough. taking much so for

Joe Sarret

Sure. Thank you.

Operator

The next Please question Raja from will with Brookline. ahead. come Kumar go

Unidentified Analyst

of therapy in you Hi. a NASH think CBXXXX I’m for regards Shubhendu Brookline. CBXXXX results. calling CBXXXX say than for on that promising Congratulations example, are X, do drugs the I other semaglutide, there that effective Kumar could question had combinatorial more the monotherapy to, Phase from alone. in be just a and with for

Joe Sarret

Yes.

So thanks for the question.

as see that preclinical that patient did we not did exception we do see study And opportunity subject the an an population. is further we think drugs, glucose in other indicated there in did reduction diabetes, did significant again, diabetic synergies that diabetic to one were intriguing we have in GLPX agonist. or a work, So we didn’t mind animal with with in population. In in possibly this that – including these our patients this models, – the keeping reduction presentation, see have

given combination I not So we if that of would the in the common. be potential NASH complexities I future disease, certainly the there. surprised there therapy think there’s think And more becomes

further The to other the candidates other thing to mechanism that development. keep as in of our – unique compared product that in products action along are is mind are

there may combining So rationale for again, be those. scientific

if So more into you say. to I yes, you’d want worth think have don’t definitely know looking something I further. it’s that’s Ken,

Ken Cundy

reason I to think to that’s the exploration. mechanism there’s of a case no It’s and a be that mechanisms complimentary wouldn’t is of expect. It completely right. many these exactly worth unique other

Unidentified Analyst

terms IPF, may beta IPF. some is the in of the SARS-CoV-X much. studies other regards have done would so Yes. Thank you with be My that regulated indicated signaling where question to

may regard who for for a for patients that positive plan test with recovered COVID-XX enrollment studies, trial to during from in IPF you do have place So to protocol patient patients is enroll and the there also COVID-XX?

Ken Cundy

So you want me to one? that answer

Joe Sarret

ahead, Yes, yes. Ken. Go Go ahead.

Ken Cundy

Yes.

disease masks of Let’s experts landscape are as in from far IPF who COVID-XX the we exacerbate learned say wearing the clinical specific this that as things evolving inclusion are because subjects IPF I consequences that period in about things it’s study. protecting their exposed patients and one Obviously exclusion that during an a many of to they’re is little COVID first too better recovering. in be general. area doing from early subjects mean, and criteria is to themselves

may So someone. be having previously include not exposed not to been reason coronavirus to a

into those design consideration study. I of we’ll when think that’s be we clinical first just one that things taking

Unidentified Analyst

for taking Sounds great. my Thank you questions. much so

Joe Sarret

you. Thank

Operator

come Elemer will Please go from question ahead. next Capital The ROTH Piros Partners. with

Elemer Piros

And gentlemen. Thank XX dose you in the it presentation. that Xa? you the the for milligram would Yes. to the afternoon, was highest from I Good just that Xb portion confirm the tested like

Joe Sarret

want you answer do that? to Ken,

Ken Cundy

Yes.

in with highest the give So at selected the to respect going This presentation this dose – being the I’ll more administer the as Phase With answer information the practical full into when we into the in dose could we’ll yes, we we respect Xb. the go doses in that escalation, was one. scientific meeting. detail the dose to

on based no for So selecting limitations safety that there were dose.

Elemer Piros

site what rationale bit, you And the in you. a formulation? to injection Ken, for if see and the would the that continue about optimize is further further optimization, way you or can volume injection Thank it you talk reactions the little could

Ken Cundy

mean, with we’re I optimizing a gradually Phase towards we Yes. starts study form. can a and generally you commercial X what which the that as imagine, clearly is formulation, have prototype

stage, and we’ll the much presentation. we’ll to when scientific issues With proprietary details but respect in this at and or more details get volumes into we administer exactly that how that on on information, part taken of how – are was all to So the because we but that what dosing that’s around into provide things consideration process. like drug get can formulations can’t really

Elemer Piros

for if at line G&A Is that Thank new And potentially million expense your Jeff? Jeff confirm near-term you. would your projection, could least norm. at be that the $X.X

Jeff Biunno

go you of up state forward. slightly, steady It there, Yes. to that we’ll at years could but X that X.X that where may probably probably leave going be it around

Elemer Piros

much answers. you for Thank Yes. so the

Jeff Biunno

absolutely. Elemer, Hey

Operator

with ahead. Please Securities. question Brozak will The come WBB go from next Steve

Steve Brozak

I’ve what reduction. again have small, your increase, the was would after a it is the couple which – and on you congratulations on trial, fascinating more are significance. end group please. and end the trial but it’s the the a follow-ups that Ken in wrong plus What given an thoughts results. yours that, but And and that, questions It’s the significant What think control? had you a obviously had up do the Hey, thanks taking how got increase small, there? was control decrease, for trend statistical the the the from baseline how actually the you small do and And the I know on ALT, set than see think actually had it people increase is shows expect a that meant these would to

Ken Cundy

Sure. Yes.

increase say that effects it’s would four-week drop based think They as clearly They on a that study of difference small in shows be XXXX. you other stretch. mentioned, had the their ALT. parameters the above really you I a a reduction to expect a the not small in baseline, but did

to is very placebo substantial difference ALT. a difference XX% in a compared So

Steve Brozak

A parameters. bother this to question have compare historical to quick of seen studies they and on that lot other what don’t a controls you’ve does side? Just historical How use the some even there.

Ken Cundy

in have arm, mean, related. there was you understand to examples what outcomes, which are Yes. a exactly I it studies, limited Well, as companies don’t hard many and very for parallel drug four-week with what was you mentioned, makes respect to related placebo placebo

address definitely that with our we So design.

with and setting ours. with arms, conditions will a of by Now placebo settings, like the four-week see really some the apples-to-apples or it in other they’re Phase are respect study, X not to changes varies studies Phase to the placebo but longer-term what comparison X an study, obviously you

Steve Brozak

for even a can with have Well, you trial Madrigal, control yours a that’s that as taken place. is tight has instance, as tight or as as

at opinion that, terms were Because what their looking possibly XXXX clinicians of your this, is looking what Xb, I’m least a for is of at you’re the So curious in what was were see this anyway, more that – just than my reactions? just for this concept looking at to kind the more in Phase a at is this proof platform. of X than for

telling coming you your on? what are clinicians So back

Ken Cundy

Yes.

leader NASH. reductions, the did and for therapy was with opinion area. by level that for And a the of one ALT promise discussion he in differentiated release, potentially reduction, change the our the sees who’s key of the press this we consultants quite as mention AST So Rohit that being on corroborating this Loomba impressed mentioned as

Phase I who agree yes, more diagnostic levels in of significant of like at be many subjects actually was look were would this respects a settings, Xa liver being fat baseline NASH. risk say, you patients other otherwise ALT and would and in this So might in had study that that them these at

Steve Brozak

What you obviously made should of comorbidities patient diabetes. All there? terms one be of on these that items if curious because of, have I’ll kind are other right. because it’s in other And aware have mentioned Thank hop in even of the Last around are obviously patients any question, the that, back queue. What kind in did you and you. color, other we anecdotal issues? I’m

Ken Cundy

was and if are Yes. controlled they in include the who comorbidities, Too had from did The ClinicalTrials.gov it significant record. the detailed allowed was excluded criteria, study. with were not that’s quite comorbidity they’re long, metformin, all patients early the to diabetes, we say, really which in only although but

pull comorbidities indicator. in the out be data will as more to at an we looking not So but expecting details,

Steve Brozak

it. Got and thanks Again, call. congrats Great. the taking for

Ken Cundy

a lot. Thanks Sure.

Joe Sarret

you. Thank

Operator

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

Joe Sarret

our progress and you updating please and on conclude you, everyone, thank continued to Thank call. thank our our particularly look you joining on for the also this conference you, continued like next We’d afternoon. your us Chuck, support, for call? would we forward to shareholders

Operator

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

You may now disconnect.

CohBar (CWBR) 11 Aug 212021 Q2 Earnings call transcript