Earnings call transcript Q1 2024

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Operator

Good afternoon, and welcome to Fractyl Health's First Quarter Financial Results and Business Updates Call.

As a reminder, this conference call is being recorded. At this time, all participants are in a listen-only mode. There will be a Q&A session following management's prepared remarks. I will now turn the call over to Stephen Jasper. begin. now may you Stephen,

Stephen Jasper

Lisa Today Thank you. outlines This Executive results. press Adrian that Timothy highlights Investors and Chief Financial Chief issued is and Dr. recent business Commercial afternoon, topics we we tab. the the under Officer today. at first Harith Kieffer, Officer; a Officer; our Scientific plan call, available release www.fractyl.com financial Chief This Rajagopalan, Davidson, Chief on our quarter to Officer release Kimber, Dr. will discuss review

quarterly begin, trial of be I and design, of made milestones, of the XXXX. or clinical our statements product we of any timing relate that would for Litigation company's Before launch statements the Form products by about are results risk and the everyone Reform are like candidates, our anticipated any Securities impact ended subsequent uncertainties on over of the today to potential other company's be to operating Securities should to the its results factors. our and to of to Exchange period or Harith. if to statements matters filings and that Actual during do by preclinical events due and our those today. in set product to forward-looking or statements clinical historical is to initiation, statements Safe any important the the Fractyl's updates call March intended forward-looking forth Participants the meaning subject statements statements for impact to enrollment and commercialization pleasure as Act. remind within provided of Any other now made fact, the clinical differ protection change. of including only cash, the XXXX forward-looking Private call views It Fractyl's to of this even Reform operations with any activities factors specific the forward-looking Fractyl our Such of report materially cause to could the XX-Q or my of readouts, duty any Act and speak provide to disclaims fund trial the period time conference Harbor XX, the considered and from objectives Commission. directed forward-looking the not clinical to cash indicated sufficiency candidates the pass of risks, investments equivalents data,

Harith Rajagopalan

ago, results everyone. Stephen and XX Over you disease. for years Fractyl to with Thank a and eradicate singular call. our joining Thank I good metabolic first you, afternoon co-founded goal quarterly us for audacious

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up XXXX is year pivotal to a shaping for Fractyl. be

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Timothy Kieffer

I Prior professor a faculty British CSO Hari. to at Health you, Biocyte. Thank University and joining the as of Columbia was the medicine at CSO, Fractal in

Revita islet in a of and is and progress in Given with and of targeting where turn root Rejuva. my platform gastrointestinal diabetes training organs therapeutic then gut and biology, key review begin pancreas, I'm the believer obesity. the Fractal's a hormones approaches dysfunction passionate a to metabolic I'll cause

accompanied X.X. and to exciting Meeting. update diabetes generally These advanced follow-up, type have As in their lifestyle months of median real levels study the In after these that through to was are we was far X with there XXX patients German an our mg/dL, given X.X Type hemoglobin X registry previously post through with six a of have are ongoing of months Revita where from participants thus recently weight medications from diabetes mentioned, diabetes German unable use or body provided changes. glucose X.X% Annual patients blood been who from sustained Association dropping XXX AXC Revita of six baseline an particularly to multiple loss a of we world XX control findings average fall mg/dL Diabetes by

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and begin Second, weight experiencing an regimen. ramp losing to to the those stay they don't who even are looking off for are patients effects, medication. who want currently chronic therapy so to on on And side but chronic third, due a have and GLP-X GLP-X don't aren't

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We report anticipate quarter. half completing and enrollment in in year of the this the results top-line first fourth will

and data We diabetes type believe insulin. are control to with may support Revita X for the in discussed this study PMA have FDA inadequately patients with who the improve successful, glycemic design on that controlled

moving to Now Rejuva. on

after observed compared to gene small in our and mouse to GLP-X greater In Semaglutide potential animal therapy Semaglutide, improvements durable head-to-head therapy pancreatic large discontinuation. potential obesity GLP-X the weight gene we preclinical loss in and produce maintenance diet-induced loss have to candidates regain Vehicle solution weight studies. model, pancreatic weight a compared weight to improvements We control, have candidates in prevent evaluated

of studies enabling IND equivalent XXXX second study RJVA-XXX initiate approval complete first-in-human the the XXXX. half of to its in pending plan a half and first or We in for

In towards first continue obesity. addition, pancreatic therapy candidate for working GLP-X to we gene plan our nominating

With opportunity. the Adrian? will that, turn Adrian call update our commercial you on to I to now over give an

Adrian Kimber

only months ago, belief everyone. science and has tenure My opportunity team a short afternoon Revita a the my represents good our been initial consistently and few that our our I've by here Since Tim, people, significant you, Fractyl Thank strengthened clinically joining and commercially. technology. both impressed

issue our adopted with by very patients widely maintenance issue. evident times, It's been a this that have recent within weight therapies significant there's by society. physicians GLP-X to prescribed In and tackle

the benefits observed it's and widespread the nearly glucose patients note good despite of coverage obesity, individuals staggering However, insurance weight to therapy States reduction, over globally of million. within When examining this surpasses XXX that and GLP-X suffer year. discontinued the loss in from the United by and number XXX million XX% while obesity prediabetes, first

this adults to XXX turning over X type diabetes, worldwide. grappling with million Now there are condition

approximately therapy XXXX, of for medication $XX diabetes Within underlying were was for tied weight Type the expenses medications type glucose necessitating to over X address control progression. allocated million diabetes. insulin drugs relying to X billion X Notably, the are United and individuals these States In management. administration disease all on advanced targeting yet chronic with alone, XX non-effectively on million

We distinctive perceive capitalize and position firmly prevention. immense to disease and this a holds this tackling as believe by progression on that an Revita opportunity

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million typically achieve In integrated It four the for procedure already States nearly carried with hour. into addition endoscopies is a Revita designed procedures as patients workflow, procedure to requiring proficiency. a type cases as to therapeutic XX specifically gastroenterologists. administered annually million endoscopies tailored modular manageable is trained under diabetes. are United advanced almost a an system, outpatient categorized in by to endoscopist an than by endoscopists the an fewer endoscopic XX,XXX The seamlessly as XXX,XXX out conducted over is with endoscopist X X.X alone, Revita annually the straightforward

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an With Lisa? pass financials. that, Lisa I update on on call now to give quarter first to the will our

Lisa Davidson

of from Adrian. Germany, in you, our In in quarter Thank first was XXXX, pilot first generated commercial of which the revenue launched half the XXXX.

XXXX. same advancement first increased Turning quarter $XX.X in clinical to period compensation. million the the primarily Rejuva the program development $X.X in of for the quarter Research investment in was related operating expense due Revitalize-X of increased to increase The including compared study, to the and stock-based personnel million was expenses, expenses. and XXXX during

traded other administrative including the due and and costs first quarter services expenses, increase to personnel XXXX in professional operating same general period to million publicly in expenses with of and in million company. was Selling, a $X.X stock-based primarily related compared XXXX. the $X.X as was The compensation increased expense associated

increase on notes in decrease loss For a the in a million net a first quarter was the of offset XXXX. period increase payable warrants of sheet, of XXXX, $X.X reported an and to million loss income loss million of interest primarily $XX.X in compared of The net expenses. net million we by balance $XX.X operating earned value for related same $X.X the the in our in non-cash decrease million $X.X in fair to

be our the cash key of through sufficient will company had turn we equivalents XXXX. milestones cash million. March XXXX, Based Harith. and call our now believe operations back will plans, cash through of fund on expected development to cash As we I $XXX.X current to XX, equivalents and

Harith Rajagopalan

our critical trajectory. in a Lisa. growth Fractyl point you, is Thank at

Tim, the in key realize durable with to obesity platforms, both you of next As from the vision disease and our therapies Rejuva heard that organ Type root level X quarters creating Revita have the potential us target of several catalysts causes help of and our modifying in categories. disease two both diabetes programs across coming our

communities is type company a a this as And Fractyl identified the with X therapy. is Adrian patient told diabetes different believe there and unmet that by for health this in market Type need with less medicine. the approach, different meets needs which for are we obesity you, significant better of

of clinical studies our the obesity, X diabetes advancing are objectives. the focused U.S. For studies allocating we Revita European introduce RJVA-XXX capital that and we and IND to our and in ensure formulating through commercialization to all our our remainder XXXX, need meet to have that on we on the markets, runway executing of enabling plans efficiently to Type

It mission. like time and and is trust moment exciting and who have I a an to appreciate incredibly supported our your helping efforts also we truly patients amount They would Fractylians. past We us and our years. of I physicians deeply the spend in together. my XX the tremendous the and and great achieve thank like take fellow of build Fractyl, something at us work over acknowledge in us mission a appreciate energy would to vision, hard dedication to time focused to their on and the

much. curve call Fractyl. very up now of continued with and work your will open we our sharing as metabolic Thank questions. for that, support the you on progress And finally, to updates disease look toward globally. the to And you I'd like of forward thank to interest We we bending your

Operator

you. Instructions]. Thank [Operator

Gerberry of comes of America. Bank question the Jason of line first from Our

Unidentified Analyst

for Hey, World taking this is the Thanks on Chi questions. our Rejuva. two on I Registry on study Jason. have for one Real and questions

Real were Registry on the to World of Revitalize-X? similar in proportion the study the you some study? So study, from Real how Revitalize talk What can can about study patients enrolled Registry Registry curious the be patient in study the if enrolled for the in way? extrapolated insulin relative to on the World Curious those data

durability with to And durability weight Second talk you translate three expectation? your lastly follow-up in same you the study obesity diabetes? candidate. RJVA-XXX that for than for from the Rejuva, attributes provide or data with talk expect do similar first you well I'm HbAXc loss. obesity. look that question you. the six to of looking is data those data to month reduction into you Revitalize-X might if as my respectively? candidate about as Reveal-X[ph]/Remain-X gene and the Are nominate selected therapy month same you what line about study. on How I'm curious and And can respect curious different on have be the Thank are you for your

Harith Rajagopalan

look Thanks, sure heading there I'm We're BAML forward seeing in Vegas. you're the if yet. not you at Chi. out to conference later week I this tomorrow.

Unidentified Analyst

Jason look there. traveling to forward we in, but is are We hosting you.

Harith Rajagopalan

Awesome. an We're my for Vegas, to conference your It'll well. thanks attending time in looking investor forward questions. as be that but first

I'll I'll the has ask World let's that tackle would talk Registry and So if about Tim Real he anything he first. add. then them,

treat to patient ability that who are CE an of our across but people medical Your failing larger I'll cohort it's it is Type was opportunity that lowering glucose In of affords Revitalize-X. similar us with first Mark one a controlled at Europe, covers inadequately X patient And population a population, are that. individuals a spectrum say to agent whether diabetes, least an the it's to than therapies. similar have patients who question

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think is therapies out, advanced a therapy choose wanting other they might people have something that try as when that be it even driven to we the are are like medical to all in this And what might options, turns to root be addresses inclined procedural cause exhausted but that progressing before already people to considered guidelines. a are many

over potential and So market progresses interesting Type direction an time. the that is to in Revita diabetes might go as that in speaks its learning the for X it development

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next three provided we that. follow-up. was six about Your and question Real about Registry Yes, months the have World

it see it can sustained in months and sustained weight, that that far. one we six and by observed three You is seems within there's and month, blood in sugar and observe improvements so --

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Type diabetes X features X in diabetes I think States. has same in United Type a as the Germany lot the of

and answer sure like excited to understand, frequency are as a we are the And of as treatment? of us is those things what One necessary? questions that the And I'm what be retreatment help follow-up. you is patients more about be? that with will Will very longer-term keen have appropriate we we're Revita the durability too to Registry

the versus have that, on stated obesity for and is its Now are RJVA-XXX human diabetes human folks. peptide actions a life moving promoter question circulation, well the diabetes. short differences human and Rejuva, local by GLP-X sugar Type to driving in the pancreatic on the before for candidate a The third X has very within blood sequence. Type described of candidate GLP-X its half we your the has islet, What the as has insulin similarities been X bunch

candidate earlier very there's bioavailability diabetes to Type for year half-life showed systemic that's excited data candidate. that led order X in our a db/db we're has and presented diabetes to sugar able be this can about local blood to So lower Type us candidate high an opportunity the we improve GLP-X impressively that that blood short activity to limited mouse model and that sugar, nominate X in a and,

anticipate a We would that diabetes candidate than higher would required for obesity are an that levels candidate. get serum type X what be want to

nominate we RJVA-XXX. so loss that's in for And a be will candidate the looking to weight optimized

more the viral we anticipate type other, sequences and but backbones to applied we the that themselves vectors way, continuing same apply would plasmid the them, to to may to the the enable same would optionality. same it transgene platform of Rejuva-X in learnings delivering, deliver one will the anticipate from be be in leverage anticipate we sense using the capabilities delivering We that

imagine of efficacy for profiles. in achieve a the order question. we of in readily as use of but also much evolution of not We're or together combinations such as that of we And be that we're question and a as your multiple GIP that can the Thanks this metabolic impact, to terms agonism the keenly exploration of think other platform, advance opportunity very GLP-X in therapeutic asked, either for keenly you concurrent will impact program. in about lot you interested terms mechanisms differentiated interested or safety

Unidentified Analyst

Great. Thanks so much.

Operator

you. Thank

from Our next DiFiore Mike of question Evercore. comes of the line

Michael DiFiore

post calorie dropouts? Hi, congrats from entire compliance is, guys. will DiFiore patients few reduced a question on ensure terms my have the on trial? the stat is throughout and Umer. And will The Thanks Remain-X how the having And A Mike taking you a how diet I This in progress. stick procedure uniform for the one plan of is to in me, follow-up. all for trial. question handle

Harith Rajagopalan

great question. Okay,

people and them are obese, not to the weight be type who titrate So trial, drug. who in familiar to beginning X tolerated of then just achieving drug that loss. a over obesity not agent Remain-X will Zepbound, is at weight -- pivotal diabetic, body for tirzepatide therapy, active the of may period are dose of it which XX% GLP-X to people just naive, IDE up And April initiate the several be maintenance. weeks a maximum is approval the beginning those for our take who with plan The end got of March, study April

the diet is treatment the initiation matches we're a recommendation that are and a been through them to to At to then everyone we sham, that in similar studies tirzepatide, of time, going or way the that GLP-X used a for all through follow-up, drugs study to going going get randomize from Revita of have to for loss. discontinue weight the diets and

during other patient idea population. from visibility that that that to months the to is expectation adherence that the I open phase. think run-in several their to try So of that to similar open-label And a follow-up. into same And advice been going they recommendations have mimic have the ability that during to have to then during dietary with the nutritional label adherence of gotten translate kind our comply we're studies targeting phase is really will

the are be may effective are who You think expect considering who -- more in a therapy endpoint arm study. plan seek as that people treatment had XX-weeks the whether the Revita a drop decision have is out patients rather do at we likely to people stat that the will, really in We result, we in control if to order then treatment as keep than a great on at that we question a have to we the are we to And about in help a made to the dropout. not get those offer than as primary crossover did and arm. them a one who XX-weeks,

we're of note time, now withdrawal have But drug study year -- that in patients I keep followed encouraged followed patients able and have of a there's of one that have that lot of patients for so been background. that GLP-X that length and studies withdrawal from by to for will that

question, another had Mike? You

Michael DiFiore

just Remain I clarify observation carried before dropout? study. a the you said be about Will altogether of Yes. lapse what the will it forward type to centered or dropouts move for like But analysis be on, the

Harith Rajagopalan

question. Good

We what that have yet a be. on have -- we not should view

there ready with how carried not imputation reviewed technique, we statistical will techniques dialogue the so not to that. have the answer exactly would is that I the are yet think to about. be have do -- that premature require preferred tend say chat to FDA last yet that there but forward no FDA, observation I We it's that and in with situation, preferred this to that a is longer

Michael DiFiore

switched to last simple question prototype. in And Obviously, had GLP-X on Got the GLP-X your the the the a fully humanized it. analog year promoter you just you versus RJVA-XXX.

transduction the that was if think beta curious see Was cell the I in XX%. percent prototype, around to

Harith Rajagopalan

comparable we Great are surrogates of that question. same. differ, AAVX the the beforehand. the And delivers it remains the between levels that used The might seen but transgene we very candidate sequence have and transduction that itself

data in will of bridging get strategy when we the will ready share, part need will for this walk to so order those all about dose as and through to get And with of bridging -- we to thinking be the we we're preclinical get human you a candidate in models people. how with demonstrate able closer, to dose we

Michael DiFiore

Very Okay. so Thanks helpful. much.

Harith Rajagopalan

Thanks, Appreciate it. Mike.

Operator

you. Thank

next Our question the of comes Stanley. from Mike of Ulz line Morgan

Michael Ulz

afternoon. Maybe guys question. just Remain-X Good for to to track you on like start study, Thanks soon. taking fairly are that follow-up the on looks

timing of move thoughts going? that Just be at steps maybe looks any And updates? shared curious forward? there Just mentioned and the remaining some of sort starts of Thanks. data providing study potential to secondly, early data then sort in to interim there types there's that some might as set you maybe if getting on it that

Harith Rajagopalan

Yes. Great. to Thanks, hear Mike. you. from Great

super incredibly patients. now about it, we've have to able that to physicians' we investigators that getting and are about approval, to the talk this attractiveness encouraged study. IDE And about are feedback by excited and and its we of We the we been are perception Remain-X sites an trial to

needs that we what sites active good we service are IRB trial remain. approval, in selection, happen the trial we clinical to we leverage with and clinical that us site to leverage stuff, accelerate get intend et help cetera, Revitalize-X, in to built have have where to standard relationships physicians So order from fact networks able us order to

lot able so enthusiastic we've build. existing are about And a being to leverage hard worked to so we of which infrastructure, our

with to cohort know, respect one exception. an treated updates, there With the exactly same be Reveal-X can we way you data as that will and open-label Remain call patients as cohort be Reveal-X, the in

into see come currently can drug. weight to on loss they to Reveal if stay order and to maintain able on not who wish be patients to it discontinue or drug will GLP-X have already We on allow to in a and been have

You taking why costs as GLP-X to the ongoing about Family tracking reason may Kaiser or from the how the of have people are one talking seen poll XX% therapy just about some a nearly be people of stop. who Foundation looking today GLP-Xs may may out came not concerned are

patients benefit, that, weight FDA reason tolerability we I issues is but think Another having GLP-X. is who with that in loss as know you the interested know achieve really are

Reveal-X people drug and in the same exactly naive Remain. way allow so those in people be also is cohort to to will in who look at as going us And treated the

updates get updates they is give in study in our study won't you plan starting up on Reveal-X the we'll then to be and We'll take quarter. the get efficacy fourth the who to us titrated efficacy in are cohort. get GLP-X the because therapy, earlier already on a or effectiveness So it'll to data need -- longer cohort

the to on drivers this But also and Remain-X for to data we're year what a think as we're select patients we have nonetheless, get what Revita Reveal both going kind to and how picture would updates and commercialization. together like, we but are look you're think type progresses, of study may us ongoing give And seeing what the inform might the when. we going you might of that to pursue an going it's paint for for opportunity in the what motivating

Michael Ulz

Got it. That's helpful. Thank you.

Operator

Thank you. for to now the I turn closing remarks. like would conference to back Rajagopalan Dr. Sir?

Harith Rajagopalan

afternoon. very of your appreciate attention all much. time, you I Thank this and

on to fast firing might program for one conversation X and year from could and Reveal Rejuva first-in-human. is cylinders can discontinuation open-label type the of Revita, that period diabetes all enablement horizon. have forward one is our the X types what if GLP-X some towards obesity data on might weight for the having after be we now, we conversations here, Revita X having, a vastly with the both what of than What hope if in from I different we Revitalize-X diabetes a disease maintenance, weight we we diabetes are working heading if over see, and maintenance you options for IND about now first-in-human data you are future look type have modifying the we Rejuva, of As on about excited heading and like from on type we're be say having

we rapidly that We're to what as the and mean path as can. accelerate could for patients and motivated excited to foremost, future that are by first about desire we that possibly

appreciate So look up. today forward attention to and following everyone's

Operator

call. conference for today's concludes Thank you This participating.

disconnect. You may now

Fractyl Health, Inc. Common Stock (GUTS) 13 May 242024 Q1 Earnings call transcript