CWBR - Earnings call transcript Q2 2018

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Operator

Good afternoon, my name is Karenna and I will be your conference operator today. At this time, I would like to welcome everyone to the CohBar's Second Quarter 2018 Financial Results Investor Conference Call. All lines have been placed on mute to eliminate background noise. This call is being recorded.

Now I'd like to turn the call over to Jeff Biunno, CohBar's Chief Financial Officer. ahead. go Please

Jeff Biunno

We to Karenna. conference to all welcome Thank second would quarter you CohBar's investor XXXX of you, like financial call. results

Chief Cundy, on Simon me call Executive CohBar's Officer Joining and Chief CohBar's today's Kenneth Scientific Officer. Allen, is

Ken. issued our release downloaded website results, business by second I quarter results cohbar.com. and with begin and our today from a was financial financial may earlier R&D Simon Our an at will press be from overview and update of followed

began, drug to on remind conference statements like we statements listeners are limited that ongoing the and statements call our forward-looking in to include regarding based therapeutics, to operations. Before a moment planned mitochondria and our candidate forward-looking ability CBXXXX not of to I'd activities, the take include commercial capital laws. meaning the today's within company's therapeutic and statements potential regarding other fund and potential These but securities research remarks the may development of and partnerships resources lead the

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

results XX, fees $XXX,XXX. second or an and and statements I in increase as publicly any compared financial to results any does differ and expenses at an XXXX payments due forward-looking to now increase bonuses, General information that D&O to summary quarter. to increase stock-based was in in statements to the new obligation in timing $X,XXX,XXX. made directors define ended supply insurance, each period, expanded clinic of approximately screening XXXX XXXX. forth will peptides year option related in QX the the statement. you prior-year undertake general otherwise. due such compensation made date the are accrued decrease events increase of were due to sheet year of new costs a an administrative quarter, an in to CohBar to actual year consultants, the quarter, materially costs options during future primarily quarter by amount stock directors a expenses ended due and in XXXX, current that XXXX were of in to compared in approximately Total $XXX,XXX to year prior guarantees outstanding as current the may with in period, prior activity primarily increase quarter. in our the for year Research and in expenses set lab action revaluation an the activities not future were cautioned related update of to revise are of June the was in performance These the related the quarter, of in QX an of grants enabling of costs or the increase IND XX, You expenses and $X,XXX,XXX CBXXXX June related during for research second those to in in increase of and administrative incurred compared a a costs increase costs forward-looking to an compared increase research XXXX approximately provide of bonuses. $XXX,XXX. operating effort offset QX clinical in result an increases accrued mechanism from The not information, to $X,XXX,XXX quarter those and or the whether $X,XXX,XXX increase $X,XXX,XXX QX premiums the development increase for an to current to in an the development issued And in were increase incurred stock-based expenses and $X,XXX,XXX balance our and the performed the

$X,XXX,XXX XXXX, quarter For per share the and a XX, June net diluted basic ended $X,XXX,XXX loss net per loss to reported and the or quarter basic diluted ended XX, share June of the $X.XX a or company $X.XX compared for of XXXX.

in XXXX. XX, of million cash Moving June XXXX and CohBar balance to to had of million compared sheet, investments $XX $X.X as the as XX, December

to the of operations promissory during sufficient Simon. offering balance of issuance cash raised based that $XX from the XX, million and reported quarter, equity notes. XXXX our into approximately investments and as we call have our controlled finance the over capital As estimate now June I on turn we will to We our XXXX.

Simon Allen

call. Thanks our for has been since our Jeff our where and shareholder a provided company. thanks weeks overview It Jeff. comprehensive X everyone, of afternoon joining I annual Ken, Good update just and

to had second get CohBar stellar it. a right Let's quarter.

these to action, presenting the that we're three our happy achieved. mechanism last Let's just on talk Russell data trial Xb Xa, were of our perspective weeks tracking have a all about at milestones clinical conference to Phase of call, CBXXXX's that a for X three were scientific initiation XXXX on we addition been new report important Index. important of ago. major CBXXXX, successfully Well, and events molecular They

early as CohBar had mid-XXXX. our dosed we event biotech discussed preclinical to guided from achieved First for with the that to a in transitioning we clinical past, subject CBXXXX, a we an is first and stage when company any as milestone July in something major

VP presentation a our mechanism of by key efforts it mechanism types. have to Through major recognized a late mechanism the represents when long other differentiating Diabetes Sessions multiple action for We for a at regard CBXXXX's importance potential identifying accepted drugs. step June. Biology, of comparing Meeting XXth of receptor team CBXXXX. Scientific breakers to the sensitize this the molecular were we Identifying demonstrated announced feature the of the Secondly, of back forward the previously novel biology and ability NASH action as Grindstaff Kent Association as we CBXXXX's our led concerted American as the program in cell in insulin of a data

Finally, the potential institutional we discussed base. additional to possibility and that our to it the added opportunities raise grow of XXXX Russell investor Index being present capital and the

our to get research an will update we development Before and Ken on Ken? activities. that, provide

Kenneth Cundy

Simon. Thanks

Let's start for obesity. our NASH CBXXXX program with and lead

levels this plan that do study announced of be the available safety, a of a involves we evaluation clinical provide back previously CBXXXX healthy obesity. initial in of as near-term. double-blind a by with available on of Xb however at subcutaneous to early As an clinical note on tolerability Please on designed can XX, safety, initial in not up also and design NASH details have and to indication placebo of in designed assess Xa, relevant we've ascending of to the provide other initiated and a we provide pharmacokinetics control These listed and given is Phase time. trial setting clinicaltrials.gov activity injection. to Phase study discussed. clinical we the CBXXXX some the unblinded or the details subjects dose five this pharmacokinetics until trial July We single report Xa, and The in trial more which expected Xb on data is progress XXXX. The ongoing of made when study the significant updates part dose will is to FAD to three-part currently the to tolerability be

to effect two a each Now levels in on be active of dose six these dose on subjects, eight single involves placebo. versus

enrolled NASH from The with XX% among by assess will to administered the second as subjects includes also to relevant in NAFLD of be at active effects determine subjects And versus safety, one single MRI-PDFF FAD will stage of criteria. and to in and Each on outcomes. must stage considered each phase. placebo active randomized entry weeks eight with levels. weight. Phase four subjects trends this changes the number prior ascending the on of The these of obesity. CBXXXX up final three intended in of dose a we fat to in action involves cohort previously liver at will one-to-one healthy relevant is data seven changes have are early A expect multiple receive dose to seven-day in pharmacokinetics to and all NASH of at examine of mechanism daily Xb study daily dose the and for XX by in of assessed ratio dose a MRI-PDFF fat look or a of MAD doses dosing in MAD The at body of pharmacokinetics doses and and of level multiple biomarkers Again involves least the tolerability by stated, to and study safety, evaluation liver activity significant to final levels subjects defined a parameters tolerability MAD XXXX. obese study three exclusion inclusion the other that CBXXXX of total these will with a the placebo. be stage Subjects of study of of the The progression have FAD unblinded parameters CBXXXX using dose drug.

mechanism novel turning of the CBXXXX. to Now of action

the recent information on of American mechanism Association Orlando, Meeting the announced at previously Florida. As important Diabetes presented drug molecular the we in

cells effects works insulin available reminder, receptor hormone of it normally is via in in that is have the central presented now of in The means CBXXXX That effects which summarize to same homeostasis, of inside sits the the a energy in liver topic sensitivity released that enhance cells. CBXXXX fat by on those govern the it shown enhancement largest also body. signaling surface peptide. on insulin. was communicates demonstrated muscle greater by Unlike processes a the by of post allowed meeting most pathways we the by That a a U.S. with and the the it is Insulin findings, metabolic to that to Insulin CBXXXX As cell on insulin website. of number was receptor dedicated cells is stimulation sales disease. cells the it's to the in the the would regulator the To in increasing insulin cells of pancreas. CohBar response our The receptor. on than scientific regulates itself. a from insulin cells,

cells from receptor the free as In the insulin its blood breakdown disease to in uptake glucose the storage the fat the acids resistance, fatty muscle of to The are foundational of of cells triglycerides. liver liver. regulates controls in abdomen cell. leads toxicity cells, fat subjects impaired to of release the exceeds the fibrosis from insulin acids the life sensitivity the of that to fatty progression leading insulin capacity the fatty of in NASH. uncontrolled by inhibiting to consequences liver events its storage in excess fatty within inflammation, release example, referred But buildup in of the in with excess damage the insulin liver and to For leading the of also accumulation fat of which acids evolved downstream

investigation among conclusion consistent reducing liver the in studies So animal with of of in has in that also explain appears free It observations mechanisms the to NASH some our CBXXXX and NASH. acids cells synergy drugs to to is fat lead for insulin the of mechanism observations cells This from prior with release of unique previous other drug under is to fat in appears our fatty of the models. currently of models. cultured be our action animal and the thereby effects from one decrease that by potential can the accumulation enhancing

of of it understanding not this by potential While the other one setting interaction mechanism the presents action opens CBXXXX the possible with a the breakthrough only door insulin NASH. in of in The of receptor also efficacy the in body, the exerted major to be may CBXXXX our indications.

is of on candidates Now additional CBXXXX. the development R&D briefly I’ll touch discovery drug that beyond and the of area last

the on screening optimization around all identify property As coverage we CohBar optimize a position potential therapeutic as for are round now in novel these to intellectual efforts for ramp Index, a the past, therapeutics. undertaken completed financing and our of has we mitochondria with discussed development encoded On peptides broadly having systematic potential and peptides recent based peptides. mitochondrially the the to to to best file of up in the effort Russell

to we we Although us we and cannot project when result the candidate, that available the in of indications will evaluating expect will increased process. to overall IND broaden effort the resources accelerate the now are both range enable next

potential forward the the these to we that, with hidden activity properties uncover And data explore call to encoded mitochondrially I'll across a more we look We range Simon. continue and peptides. of diseases of as age-related to sharing return

Simon Allen

Ken. Thanks

for at Let's there There look competitive unmet currently therapeutics. CBXXXX. NASH, little landscape for the market opportunity need is no the and doubt are approved medical in

in We with published is estimates measured having the of U.S. of the to NASH. adult up also believe XX% dollars market tens opportunity billions population of of the overall

[indiscernible] note remain significant success before is that on the we NASH our with the and call, important While the it risk to of they discussed time reach market drug. last

We to this track continue landscape.

Phase of Just and Gemphire's worsening liver damage. based Xa noted last the of we pediatric NAFLD trial markers termination on week in unexpected fat premature of liver

also and therapeutic field segmented. it the fluid While competitive, and for NASH is remains lucrative

for to the improved partnership of have believe development NASH There another continue targeting mechanisms work We have as and stages noninvasive [ramp] losers diverse set trial winners with of designs. MRI-PDFF multiple with real be such in we potential The different on diagnostics that way, monitoring new the to and continues a programs landscape. disease. and are clinical determined. opportunities landscape to yet the partnership evolve to Put

important Gilead expecting mechanism is the are we where unique define this A landscape. clinical to profile. and further likes product Allergan novel landscape or CBXXXX its We and readouts believe Intercept, given well-positioned from

of fat in the on medical given limited need loss of We continue and that models obesity. unmet novel animal weight a obesity opportunity effects believe significant for competition substantial large mechanism additional for to action represents its CBXXXX body a and and

safe weight no for this there make loss profile drugs in are need clear, the remains and that the While effective marketplace. drugs such

that untreated, patients healthy obesity treatment. that I such becoming also believe increases disease increasingly as requires are and reducing obesity dramatically ultimately lifespan. NASH that We and disease providers healthcare cardiovascular a aware comorbidities Left cancer, is serious

to attention for our our future. turn the let's and Now plans financing

in second financings Jeff quarter. two As mentioned, we the concluded

of was approximately $X first million. The completion the we note raised and warrant promissory our offering where

Russell of was impactful The offering second we Index. that the Russell far and was possible their the United U.S. us the that did a capitalization the made all Index publicly addition ones XXXX being Two a equity more companies and XXXX our on important alongside exchange a meeting placed States. into having top market listed controlled to in major traded requirements. by Inclusion within

the this recognized We the Russell Index are small which within cap also well companies XXXX of represents part very group.

on by volumes controlled place as Fitzgerald. added track able opportunity the the are period equity that traders positions this of $XX warrants. that formally a share inception here. were done June Two took now putting that sitting and successful our to It XXXX Cantor no and important numbers, our points We noting trading million a $XX Since during in the million, price expected CEO cash our funds $XX noted this and would strong go $XX million. million Russell has thereafter. We is of announced in and capital round and worth index up We was rebalancing raised average completion company. with on should XX raise $X.XX are shortly at advantage in spent were to CohBar of balance the take a of offering be minimal Index an commissions with

applications is everyone that had XXX time use ever family patent of money exciting have to non-provisional more clinical the a reaching than this whom spent First, that to MDPs. peers pipeline cover and an preclinical of of productivity many provisional and We efficient and our without and stage far capital becoming and more encourage a clinic. our efficiency highly biotech compare

XXXX history to comes We're one-way Phase us company. take largest a reserves a this a From to relatively prepare the and ramp through into and Biotech. critical Frankly, at both for to to Xb CohBar. a we position program in perspective, for strategically our joined Phase activities the a financially identify of time to additional We now to a X stellar candidate. successfully and balance have runway our long a quarter. stage transitioned drug the lead in XXXX expected and cash portfolio mechanism molecular Index now extensive was prioritize of our raised we are $XX XXXX, of partnership R&D for approximately our We Biotech. identified important quarter MBT summary, for the a second CBXXXX and million. opportunities. strong of our action candidate cash up We an second peptides In to Xa, Russell a Secondly, advance development clinical

the turn I'd of that, our treatment And for first mitochondria in We the drugs to based class be like first potential diseases. a for Q&A. Karenna? to the with are it with clinic very age-related in to new operator ever of therapeutic, over excited

Operator

[Operator & go Company. we'll take And with question Please Ed ahead. our from Arce Instructions] first H.C. Wainwright

Ed Arce

on the a given months, quite the were year. Congrats all where of had start activity you last the few list over of and you accomplishments progress at just of

you is, your how candidates areas So the how types mitochondrial Thanks. with am wondering fit - and first uniqueness unfolding through first I you - mechanism think in as would therapies, for ultimately mechanism I combination along the as you how thinking in disease and for spectrum fitting and see think the NASH, combinations? the and different they the the of see about entry class of of also about CBXXXX actually

Kenneth Cundy

we've Ken, for action it’s is a we CBXXXX. This learned thinking mechanism something about Obviously been good question. it's the of since

action latter would that will Ultimately prevalent. be drugs there progression, is more reach where once as see back data to it we that you the one and the The We drug. will between more have shown of presented CBXXXX way NASH NASH of start there be market, in is, past, is agonists for synergy treated cognate in know, the we those drugs than stages mechanism fibrosis by GLP-X towards the AASLD. at be the

they will with I that original on CBXXXX. in that be will would also are addressing mechanism the the which and the with steatosis, even are etiology, that the for this be point that for of not the think mechanism steatosis, problem, drugs combination their drugs identified treating at cause we've used be market

doors, I other in issue. open we'd other think used point. does where for settings great So, is us used be that for to a be It mentioned position at with be the in various also combinations in drugs an drug to our sensitivity insulin we

for a think for So, just disease this bodes but NASH, well I treatment of other condition. not metabolic

Ed Arce

the data to early look as to and other cash year, clinical next is, have that forward the just progress you question forward. first really now And you some program

You also did you terms you're candidate, around a more could think and details might give of looking at mention potential and of the second that in Thanks. a naming that. that areas you sort around target? what identifying Perhaps corner you is

Kenneth Cundy

Right.

wide on identification to the able going position range process a this we But that to position in we'll a much second and disease, be will for of we peptide, of NASH resources yet just related evaluation drug diabetes, a we're of be NASH. to diseases able in also believe not exploring accelerate We're certainly but a our where second identified. to X broader as a setting So, broaden CBXXXX say here, not we're the forward increased those exactly with candidate not and in spoken the be question MDP age-related It's we've follow type peptides. cancer, when past said, and our obesity, is a our new candidate opportunity. as NASH other a about with may of of cardiovascular be neurodegeneration. the We're in now

Operator

Wayne] with question We'll our from [indiscernible]. [Mark Instructions] [Operator next ahead. go Please take

Unidentified Analyst

a solid in X the type is today. plans your ask or wondering CBXXXX. NASH establishing data toward from to your Phase view the and nice diabetes, relates to on indications and Xa a Xb as what obesity Xb is, be What presentation clearly year, it of inform I'm Phase sufficient to year. you're would based next trial, intending on wanted Ken Congratulation Phase I

Kenneth Cundy

be in results move the diabetes question Xb to type we the of with would alone. not expecting Phase Mark, the Good from X direction

we type other know open that that's a there make comes but door information, think Phase to at Xb, I in X upfront for diabetes synergistic. evaluation also with we'll look point, We that data be would we'll not much decisions in looking NASH. and But expecting of are direction would CBXXXX drugs from where we're lot us. not those of I currently fat will say that the combination X obviously, weight be at is the the at just and but a type of a And head other obviously question very data in mechanisms body pursue liver before biomarkers. the those and diabetes

Operator

have Instructions] [Operator it questions at time. further no And appears we this

Simon Allen

make another Why just question. the if sure hold for don't we or everybody considering has a asking that chance minute line two, open they're a

Operator

have no Capital. Chase Certainly, a And we'll go it problem question, take all. with Hills ahead. from at do Clay Please Torrey we

Clay Chase

agonists, you further information that give to pursue little us and an area is a more on pursue? term synergy your Could near bit GLP going you're with or that

Kenneth Cundy

is Sure Clay, this Ken.

last some you - greater with data, an which at was drugs Liver presented than CBXXXX AASLD that when parts. member showing effect fall the the GLP-X Liver the saw recall have of the of two market obviously is a class, Meeting together liraglutide produced combine We we leading may agonist you was this back that Meeting

we open kind refer exploited combinations diabetes, the in looking we directions, for that have at that once in that Xb decide in obviously Phase synergy treatment therapy pursue the would be should it's that possibility monotherapy for liraglutide is the that's to. used at used X of of question type to treatment obesity. And of being various because we to does it We the hand the So, definitely point. data addition of

point. at us as this I are think, open those said, I to doors

Operator

Instructions] [Operator

Simon Allen

there's All the call? conclude we why questions, more right, don't Karenna, no if

Operator

at ahead. problem Go all. no Certainly,

Simon Allen

catching look up Take the care. We very for joining with forward the thanks Well, next on you much call one. everybody. to

Operator

you Once conference. Thank for conclude does again, today's your that participation.

may You now disconnect.

CohBar (CWBR) 14 Aug 182018 Q2 Earnings call transcript