CRNX - Earnings call 4 2023 | Crinetics Pharmaceuticals, Inc.

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Operator

Welcome to the Crinetics Pharmaceuticals Fourth Quarter and Full Year 2023 Financial Results Conference Call.[Operator Instructions]I will now turn the call over to Corey Davis of LifeSci Advisors. Please go ahead.

Corey Davis

Thank you, Sergio, and hello, everyone.

Joining me on the call today are Scott Struthers, Founder and Chief Executive Officer; Alan Krasner, Chief Endocrinologist; and Marc Wilson, Chief Financial Officer. Also joining us for the Q&A portion of the call are Dana Pizzuti, Chief Medical and Development Officer; and Jim Hassard, Chief Commercial Officer.A press release announcing the fourth quarter and full year 2023 financial results was issued today and is also available on the Crinetics website.As a reminder, we'll be making forward-looking statements and I invite you to learn more about the risks and uncertainties associated with these statements, as disclosed in our SEC filings. to content not could of other stated forward-looking differ on in of SEC statements are company's filings, specify and or annual statements statements associated statements such results uncertainties report Form contained today's their time-sensitive also is Crinetics that conference information news actual materially this XXXX. including due accurate the the this and broadcast, are forward-looking the release, qualified a company's call entirety, contains performance guarantee the only news implied with in releases, Such February XX, the the date to and XX-K.I'd company's by live like that business.These cautionary its risks from those of in as any Struthers. obligation to of this Crinetics to statements or after call update the Scott hand or revise over the forward-looking circumstances no to call.I'll date events reflect takes now go Scott, ahead.

R. Struthers

us and Thanks, quarterly Corey. everyone, afternoon, results Good for thank for call. our joining you

the We calls.To long-term continues we've company the provide building in candidate, that its begin few I forward simply on $XXX very syndrome. Phase some our This continued a interactive a suffering developed, statistical with, on in financing our strategy.XXXX discussion have received Chief results XXXX, equity different that for quarterly Endocrinologist, tremendously towards from say we of detail.Before successful IGF premier who more for today. and to spend to million we intent more Paltusotine range fronts. to recently I'll in company a started that recent to Crinetics earlier and we clinical step opportunities regular outreach We're trial programs III get control a secondary results of patients call acromegaly announced our in year dialogue. our wide data clinical one lead exceeded existing placement are met diseases. To discuss maintaining indications today it's investor of all to support moments financing vision paltusotine. wanted which the development Alan the is our the how reported is private your with forward expand PATHFNDR-X from endocrine high review to expectations.Our primary help summarizing for over endpoint to approximately share and appreciative attendance and for future to look impressive our before of our As a and our being and accomplishments reported begin, appreciate shareholders commercialization, progresses new endocrine-related was turning Krasner, carcinoid acromegaly In endpoints with it deliver September, significance. X of pleased and many achieved

acromegaly of clear for study excited now confirmed is in XX reported subset evaluate -- oral reported paltusotine. the total we track tolerated studies in continues trial consistent that who indication year. built trial are are somatostatin remarkably part population, as already designed year, to depot, of the patients carcinoid PATHFNDR-X for forward carcinoid are into reminder, this key a carcinoid out to be who of in for on the of receptor who patients care, X other is agreed standard seen from in These indication treatment episodes. care and to in the As were of of which on In untreated an entering controlled study.We we ] regard the to was or in the enrollment to we in complete [ therapy, wash December, injected patients results label clinical injectables syndrome, months, care the the We're at words, naive Results patients, both range. paltusotine to which safety have we from what with this are in is PATHFNDR broad of a FDA top Phase switching results from IGF program PATHFNDR-X, of our in top pending elevated our and are and these U.S. to levels Phase unblind the and a II acromegaly.Now trial, treatment, results paltusotine.In patient in initial ongoing second the movement our and patients. second the to with initial other with this efficacy, paltusotine excess are III of in to-date.With our III maintain evaluating studies control from first that once-daily reported above line syndrome, symptoms patients to intended study the patients acromegaly Phase From alignment patients of biochemical report we we've standard who the on X for least flushing carcinoid PATHFNDR-X syndrome. intended December therapy.The support paltusotine we in results intention SRL standard are second expected a fully by If syndrome for seeing acromegaly either from provide pipeline. the Completed we are footsteps view, in from last studies oral to-date NDA FDA normal intend of move is reductions successful, paltusotine, the open-label March. to the a of with to our ligand an with of to maintenance XXXX. supported of initial to In bowel deep line contrast, well design.Following results half we a frequencies point profile, half with submit to the in Overall, or is results

developing second in a cortisol crucial, adrenal XXXX, antagonist commercial second this for or that agreements, ACTH on Moreover, by evaluated multiple the make patients of in and rest hormone, few XXXX, III and Chief provide molecule, PTH, II, Phase generally of and Hassard emerge important quarter we a of focused on capabilities adrenal obesity. pipeline, receptor our finalizing designed on beginning early when specialty forward patients initiation make also to also patients.Understanding pipeline data to second antagonist and with about together for antagonist preparing know XXXX CAH, Graves' to opportunity. initial and a the in TSH of the for Chief acromegaly, a in continue Jim prevalence invest our and the roots excess Krasner, if to treatment markets, Phase levels discovery stage our are indications ACTH-dependent and present creating clinical of our trial approved. the pre-clinical PATHFNDR-X androgens. disease, and People Endocrinologist, of syndrome of to advancing Acromegaly relationships adrenal including strategy. talk an me completing is programs and and or just also we're metabolic XXXX to ahead, in [ in a let carcinoid results continuing the world-class with eye treatment normalize followed our that commercial in ] a subset is diseases, Our seeing for and all candidates the III elaborate payor disease. will build and advance paltusotine, We the over a plan remain and and is launch also program acromegaly and pharmacy We'll building in Alan a is CAH congenital well, we including to Dr. many on candidates submitting parathyroid market Officer initiating preparing thyroid to year.On we're transformative commercial an carcinoid of today. multi-billion hyperparathyroidism, identifying our our and Commercial PATHFNDR-X, XXXX capabilities you for anticipate these appropriate.In diabetes paltusotine with team,to disease logistics, stakeholders, that, completing the readiness are in organization. completing we instead first a Alan a potential and Alan? success.With II these promising updates from prescribers company 'XX, these are perspectives multiple tailoring carcinoid our among Phase unable program, our We're out results long-term key hyperplasia, of programs, is These of Cushing's currently the with launching resonating other development regular market prescribers anticipate NDA, study access anticipation fronts.Looking CAH, and for the hand launch syndrome reporting of milestones from excitement that trial being with open-label dollar building it we syndrome, candidates II high Phase Phase actively our patients discovery. to and of are oral androgens, and

Alan Krasner

from Thank and you, will reported with summary provide a means Scott. our recently starting I Today, clinical continued paltusotine. we the development, the programs what for of this results

out trial or Therefore, highly As that are the primary was the out already the liver IGF-X.Participants set evaluate and I excess study.In study achieved The IGF-X for than less PATHFNDR-X or we of was paltusotine maintained endpoints, statistical of participants X insulin-like like equal while the patients the to XX to maintain Phase only at in or difference to endpoint. with of PATHFNDR-X statistically patients statistically designed than previously patients into who patients This those group this levels, In proportion growth therapy significant with the markedly. rose this X.XXXX. we who switched this a p-value of who is biochemical Scott of placebo.Magnitude maintain trial symptoms secondary remarkable goals saw on results X to III baseline than to to or and per acromegaly XX nanogram less already significant compared maintain clinically milliliter. of paltusotine limit using primary important factor excess a of our paltusotine to of the of in the oral than XX our hormone X and the in study, at limit from growth statistically all fit-for-purpose diary, normal. And mentioned, levels baseline treated received level a acromegaly Participants primary goal paltusotine this in of September, to endpoint X.XXXX. or normal endpoint with p-value in of IGF-X placebo.We in receiving control. IGF-X reported placebo we therapy Acromegaly, this the upper the all difference of secondary IGF-X, injectable proportion I'd patients levels trial In able a Change the achieved significance. injectable growth X, of significant change symptom biochemically paltusotine. of And times levels was secondary on with dive compared paltusotine all for was the paltusotine the hormone, pre-specified participants to were as is secrete less reiterate X%, and X had XX%, also upper data, control highly also acromegaly to SRL -- acts meet endpoints.Before in of metrics times equal SRL on endpoints. and controlled less

control p-value symptom difference is paltusotine compared score.Participants increase significant, of overall symptom was an to addition, by overall diary, baseline, group. as ASD symptoms, control ASD their measured or using In maintained reported the placebo The from This was the by receiving X.XX. the total a of with as statistically measured acromegaly score.

significant growth levels.SRLs of with Treatment currently study.The therapy, patients and participants PATHFNDR-X the statistically by X populations data level to normal with for through once biochemical in not treatment the is XX% we demonstrate X.XXXX.We're agent the nanogram milliliter first-line on the These because treat meaningful IGF-X burdened very paltusotine issued maintenance placebo. acromegaly population with have symptom convenient of injections. includes depot is who p-value in those The acromegaly, maintained about trial; published than daily the here the evaluating XXXX, medical are that therefore that of firstly, therapy medical limit have acromegaly, currently control results who very hormone are guidance greater option This that interest: of Finally, a measured treated to compared active than show for as XX% currently these have in per are receiving patients elevated active SRL our were oral maintains development a levels of as that levels in are range.In a goal difference are also durable population currently that evaluated was that lowering used patient IGF-X. IGF-X untreated in on FDA and less new drugs X who identified demonstrated the for PATHFNDR-X highly upper an normal. most studies effectively excited practice the disease population January in IGF-X lowering paltusotine can monotherapy when the clear of direct of treatment by secondly, acromegaly

objective treated SRL proportion benefited with from end compared achieved the normal with minority primary treatment. of but IGF-X. among objective a which PATHFNDR-X. of are at medical patients untreated it It potentially of treatment of those not start is with possible the demonstrate Although a This naive of only range is statistically was an will who to patients is paltusotine who IGF-X the wide particularly majority therapy, normalize, of patients, baseline that placebo with studies previous that of purposes, therapy.For IGF-X actually out in PATHFNDR-X predict regulatory subjects greater to same known primary elevations on normalize to the to

normal note patients that PATHFNDR-X patients than known in rate that study absolute elevations a the drug the that IGF-X at in monotherapy wide of the has who population. injections the at achieve in estimate important PATHFNDR-X placebo normalization this should first-line should on to overall to the were at normal than in IGF-X population.Remember, have similarly IGF-X PATHFNDR-X would However, And best group.This show this be of it baseline. therapy. that the of lower observed PATHFNDR-X data, able in all is to approximately with indicate that this the rate be to a different paltusotine SRL expected Based expected compete expected have published IGF-X is XX%. power would is patient to our end of percentage on to as effective injected be normalization population on PATHFNDR-X is SRLs baseline. It be range treatment to

the we that an this and disease serotonin intestine. perhaps key and X are production secondary the are experience syndrome reduction open-label PATHFNDR-X of patients practice, currently well-tolerated the new be this relevant tumor patients burden. first-line diarrhea acromegaly. symptom paltusotine oral treating in syndrome, you is half we've consistent in initial paltusotine. complement was participants. The also normalization previous month. promising enrolls SRL results results, the endpoint to XX a commonly achieved we who we in for to reported most indication, from in from prior total carcinoid patient paltusotine either showing line top carcinoid to II trial that in sharing syndrome XX we will patients of can reduce to with what by a that is from the for a in first PATHFNDR-X indication our included with enrolled carcinoid ongoing pre-specified brief caused from completed results total with in December with that us enrollment and PATHFNDR-X.In of II syndrome, participants. with other and In would Phase arises therapy, Phase participants, neuroendocrine PATHFNDR-X is no ] medical Although anticipated is untreated, look out are and with would clinical or safety fully is syndrome parallel-group hope target second the safety the injections next wash that goal baselines treatment, symptoms entry. results of even with IGF-X interest, And more to to point year.From is Paltusotine's this top to-date. from paltusotine seek and allow expect open-label PATHFNDR-X treated, that December, with The [ The elevated the studies. line flushing.Our of the actively SRL or presented enrolled of originate population paltusotine results SRLs key naive to on full compete We are treatment a their The are broad XXX a initial forward willing ongoing This study trial.As therapy controlled small is seen this findings, in study factors. results view, as who is well. in and tumors reminder, symptomatic, Carcinoid are in study the

who pharmacokinetics in experience very patient prior have already remains experienced one XX% a symptoms per frequency movements see day study paltusotine addition, with consistent to greater the population data.So and reductions meaningful baseline, flushing bowel In X movement is even in in pleased to with who what flushing in carcinoid these patients from far, associated reduction the this key XX% reduction associated in look a healthy episodes, also than events the volunteers. at per or of In is bowel expected in We're we observed syndrome, bowel patients paltusotine also X with movements more excess episodes. the entered and with at initial day. excess

study the dose pre-specified increase symptom patients on opportunity design, dose. their the the required initial participants an time of had based part the in criteria.However, analysis of As in to up-titrate the at study few of paltusotine

we to in we're first response. be paltusotine observe believe exploratory year.Based SRL and Results this data look reported an results correct and is far, anticipated and acting data will results, of initial we final of set think of and will top endpoints range forward the reviewing thus this. believe analyzed full like which half provide terms in in full we the symptom with on results. line its We're this supplemental So, ability confirm relief, are the excited the the a to to other biomarker about

a dose, including discussions.Our of We discuss XXXX endpoint a of the you will timing II FDA congenital design III development an and that CAH XX,XXX receptor CAH. the cortisol to the details, ] androgen.As or an to of adrenal participants U.S. is have overstimulation open-label updating development, which the patients to is study in primarily antagonist, production candidate adrenal affects causes CRNXXXXX. of Classic At submit production. resulting sequential in Phase overproduction had is second at CAH. adrenal adrenal for causes meeting. and XXXX genetic of with directly This stage disorder the of this XXXX. impaired normalize these forward in high registration, is Phase we've in are treatment look we an safety being following on interested hyperplasia, currently end to ACTH of These XXXX [ ACTH antagonist act in at excess designed dose We NOA studied the ACTH. the gland final pharmacokinetics levels androgen to trial evaluating patients data II approximately paltusotine in cortex, once ACTH is Phase

of in the we're and interested data or in carcinoid from in data will December, is presented this an a to to Phase to However, be in report We plan also data review participants. the initial data, is from patients.With pharmacodynamics, will This how over of Marc second in acting using at we measured quarter will enrolled we biomarker give hand XXXX primarily full androstenedione, hope XXXX. not II the CAH, initial CAH early of looking number AX.Similar the study of a for open-label picture now that, it it how but small I financials. us syndrome the

Marc J. Wilson

million on with in strong Thank Alan. financial ended and We $XXX.X cash investments. you, XXXX footing

a announced forma approximately $XXX earlier today with strengthened addition, position on a placement basis. we financial equity financing. This pro $XXX our private placement million million private further In

to regulatory to and services, foundation and XXXX. solid for milestones, our were million we upcoming and in year $XX primarily prepare in pipelines.Research both ended full million XX, were for personnel were year XXXX, a the by readouts, to ended higher and data and and expansion million costs as same million for XXXX, to the we portfolio and XX, for ended $XX.X expenses quarter periods for $XX.X our and continue $XX.X million XX, for have outside expansion $XX.X compared financial increases December attributable We of driven of the the the compared investing and period higher were million deep advancement net $XXX.X December increased which the as and the and loss full December for was of administrative expenses development quarter million were XXXX. XXXX. The attributable periods same of and $XX $XXX.X multiple net in a to XXXX, programs.General same loss primarily of the million quarter These million $XX.X $XX.X costs.Our increases in compared million, personnel

periods approximately hand XX, quarter XX, the the the year to during to were announced approximately fund to Q&A. full private for net company's compared December XXXX, XXXX, XXXX.I were Revenues December $XXX.X was million begin arrangements that million December the with cash ended cash, loss year our for into revenues ended our that burn $XX the the and XXXX.Revenues ended million $XX.X of now $XXX same $X.X to the million, There XXXX. $XXX earlier no and derived pro our XX, candidates.Net to closing for licensing December forma remarks year current quarter. in a period of activities it for million $XXX.X Scott anticipate be primarily cash was we XXXXX product equivalents sufficient be XX, will compared back quarter same per to for short-term and million million the $XXX.X we plan used XXXX. compared placement operating to XXXX. in million, million million net from XXXX, the ended period expect for were in $X.X ended for both following in For we will loss And million same was period cash for $X $XX XXXX, paltusotine operating XXXX, the before CRN our investments today, associated In

R. Struthers

with your commercialization, take ready far and XXXX. XXXX drug progress poised our continued a all so to the extremely advancements and questions. progress paltusotine, you, our for discovery Crinetics. you XXXX throughout regulatory through We to efforts. is forward proud updates in pipeline, providing as transformative continued in year And look be Thank submissions the attention.Operator, Thank candidates to Marc. made we for year throughout We're and new we've of continue to we're make exciting create

Operator

Joseph comes question first from Partners. Leerink Your Instructions] [Operator from Schwartz

Joseph Schwartz

Congrats on all progress. the

question first PATHFNDR-X. So, on

this who not are didn't? that do are you a the SRLs previously of in of ] many to trial have medical those how sense For responded that therapy, them [ patients had versus enrolled currently receiving

R. Struthers

question. ] I'll Alan let [ answer that

Alan Krasner

largely the haven't are patients in where therapy in the the basically not in left principal study, the known evaluated. investigator, to who a trial not doctor for responsive to if in for which the past theory, So, of group the recently at not to being have be to discretion screening is the medical should research they're this that been medical study, therapy, or patients site, to to patients, but medical prior in be is or those really treated not responded eligible SRL this in known therapy now, past they

Joseph Schwartz

the assays' years were actually, PATHFNDR-X. for many using was assay that could do translate the the the assay could you And patients that the you're have to results? Do have estimate in how differences a into? how question IGF-X for And in studies that and measure for influence same ago sense octreotide population? on for rigor compares so, any another much in used to then, lanreotide done if you in the any And PATHFNDR-X the

Alan Krasner

Yes.

by XX, very last rigorously the immunoassay even are area of That's a more reference XX assay is the assay a years. we for than research the is IGF-X. major gold IGF-X currently the ranges age over And that central for It's using So, up-to-date been laboratory. probably an measured is validated. what important standard in itself

patients we And into account And potential world's that the calculations could mean, versions studies that differences using with worked available assay There assays a have to good this the our you're so, on we older previous naive with differences. And and more the the could more assay. also be be we minor state-of-the-art assay significant acromegaly. of But we're used in -- study. the have more older were size for think previous we there on in I ranges technique. experts particularly done taken comparing for at recently research, the reference sample with handle -- measurement right, differences. have But time.However, recent

R. Struthers

Joe, the and -- because get those think importantly, the more earlier this of further difficult back the it assay but that reference time to is largely add So in for compare also with our and does assay. these -- I to you more studies go data and Scott, perhaps more ranges

Operator

Sandler. from next from Your comes question Yasmeen Piper Rahimi

Yasmeen Rahimi

all on has Alan. whole CAH? has been to the PATHFNDR-X progress. investors my wondering data us submitted first any or then the And been question for throughout to Maybe second to were carcinoid morning all Would hear the related that is question investors color. your previewed love Congrats if or the [indiscernible]

key is in unmet forward If you could AX for should what what bit these exists CAH? patients? the reminder for maybe from a endpoints interim be a considered little reasonable looking maybe maybe share we also could a the clinically be to other meaningful And that sample that need readout of of size a difference in levels, and

R. Struthers

answer will list of Alan? trial This were want remains everybody, on a that side, the disclosed to with vision And were obvious workings and me, to process. investors be is the or know discuss isn't high-quality funds from it a the readout. and ACTH about and can't And understand named our PATHFNDR-X month. we release inner that But be the should or blinded to everyone to I press that you, of deal through willing support in great outcome that list single included in existing long-term the a This company. deal and that. handicapping growth and our some view long-term new of of deal, the wasn't that a short-term deal next

Alan Krasner

Yes.

about about What efficacy. reach some is to an questions appropriate CAH those the conclusions all study. for are sample pharmacokinetics So, us yes, great and size safety

from disease, which the and like analysis from patients, our example, hope we'll that we a we say what This small this there at a for and not by is is statistical many things a examples recently patients lot I'll that dose of I is exactly are diagnosis changes what's response the we biomarker visualized clinically on -- of disorder, directional easily this important, clinicians, which reporting a syndrome.This And is right data, bat from is well now patients biomarkers on more we look So is that endpoints of the CAH.I for did have off carcinoid in qualitative we you look are with pre-specified we these like female like baseline probably asked the too are the first II meaningful that in can we And will is relevance the rare exercise. think, baseline. most in menses clinically Phase many clinically. these in things be androstenedione, to course, -- are importantly, what's pharmacodynamic that, biomarker even I to the achieve disease. mean, there as also we can would be change course, that's of fact, based good lot very interest, are meaningful also interim potential of doing mentioned. as doing And how you for, things follow of And normalization study but monitor other looking are in -- general, front.And are A end that And therapy in have are most infertile.And mentioned, this think, on look, at, other I of XX-hydroxyprogesterone be exploring irregular by a that most we pharmacodynamic of carefully. in what pharmacodynamic cycling important can of signal the the this in some clinically what's another AX, and there we'll as levels AX But other elevated of what know the menstrual as front AX besides with used on most women half. we we of assess directional -- closely.

Operator

Your Chase. next JPMorgan comes Jessica from Fye question from

Unknown Analyst

This is [indiscernible] on for Jess.

to for thoughts close what any for very update? provide there? plans we're your help So, represent some updated like Can carcinoid carcinoid. full us on can set then that And syndrome? III for you Maybe Phase data expectations a you would win

R. Struthers

Yes.

already. with I stuff reported that So I pretty our December. interim mean, impressed thought pretty was I winning data was in

small And reached important study. very some kind in of these significance, even endpoints this statistical of

more not supplemental set information our we like really biomarkers interim movements, goes experiencing see It And data may interim on and of only I data flushing bowel is are very a other hope recall numbers. episodes was report, excited confirming win other to information excess would sort associated reduced. from also, most but what data. say the patient. kind very goes severity -- and meaningfully saw and were So, numbers endpoints, of of those the example, actually also paltusotine, what's bowel have to to and movements to final the we also the episodes important those is the of points.For I what That data beyond flushing exploratory urgency on in key for expanded of you also reduced patient just our the

So, as of information hoping patient-centric well. additional I'm we'll kind have

Unknown Executive

Phase on And maybe comment III?

R. Struthers

Phase with actively sorry, obviously, deal. Yes, designing I'm to great help a our are III. we using Phase database and Phase that we're III, II

we'll that discuss a with based In the XX III we this we trial.Based fact, XXX be sample Phase regulatory the endpoints the know Phase will for on III trials that a study We're FDA. them. exploring important that's area we that III variety group FDA, placebo-controlled report for designing historical proposing And primary the with of think are secondary on will I Phase discussions I do Phase for back process. well as of roughly, anticipate likely we've say, endpoints size up the database end again, we'll this the had as once kind history precedent, potential trial. the to II And and in key general between a parallel those essential patients. -- really is

Operator

Your from Jeff next Hung comes question Stanley. Morgan from

Lee Hung

importance the having that about and a acromegaly have for talk symptoms in I strategy your And then label? follow-up. the you of the included diary Can

R. Struthers

Actually, I about a it. that's think Chief depth. it's that, little Officer, Commercial amongst important And the to Jim, point maybe out unique could our very excited more and we're in answer SRLs, fairly

James Hassard

Sure. Thanks, Scott.

symptom quality a component as So mentioned, Scott not of or competitive diary label. been life of the has

and communicated to. forward in And to leaders within in the but Symptom it all the look do patients globally. label it's symptoms it's patients, we control deal.There's is certainly or about they key we be opinion whether that is publication, the will it's whether something is as as something that biochemical it speak and United So how States acromegaly control certainly among to regulatory feel. a big with endpoint,

commercial it So, the performs be physicians. for it and from paltusotine will patients a conversation of important part standpoint, and of certainly will a how an big component be both

Lee Hung

what thinking And is latest what ] payor and strategy your then feedback so far? for paltusotine, for the the commercial has been been [

James Hassard

Yes.

with, patients strategy going possible the are us we have will allow -- to provide both will and is PATHFNDR-X I therapy. treat PATHFNDR-X market commercial So that mentioned, Scott Alan under broadest hope, to currently label us naive as and and patients that and think

XXX%.So payors the a number marketplace, will through payor In average -- [ that of an the setting, the XXX% with on co-pay the injectable the I very, some -- that [ we've tell are PATHFNDR-X for well. proposition, community of the that hospital delivered also high on a based with relative can be can ], and ] the in analogs discussions and channel having response markup within outpatient we very injectables this about for that terms enthusiastic.In And segment, markup hospital and payors on had their in offer value on terms within [ as as boards delivered where care data, continued ] both occurs been payors of market standard a is ] of has oral just within or something research [ physicians pharmacy as, patients speaking with also level. average, savings a [ you we're have to paltusotine cases, there terms as that is somatostatin with the been and ] advisory pricing for and as that specialty system of the about high the depending certainly markup within payors

Operator

Your Cory question from LifeSci. comes next from Jubinville

Cory Jubinville

all last question made acromegaly. Quick on progress year. you've Congrats the on

acromegaly, spectrum adenoma into this understanding whether in Can these to or So patient give a historical characteristics us of has [ a a the patient there's previous versus or a more correlation passed a the response studies were age micro-[ sets, look ]. baseline such group? with and across strong across as how certain data naive a better treatment insight taking demographics between all study align macro entered ] the broadly you

R. Struthers

sensitivity done study I of the the think that a yet acromegaly be this of general subsets part the the analysis simple Phase haven't and and answer is III with think we that global of population. some representative we will are workup. patients But broadly, is

Alan Krasner

in high to expect of can where -- compared IGF-X normal. that should where a it's knew get this of If years, not is it's IGF-X medication. we PATHFNDR-X to on just at previous study we lower reiterate in very start to there acromegaly. I the predictor take response to patients the most from in kind what high, was more done going studies one rate level. That's treatment in think easy with looking lowering out normalization to identify it literature at IGF-X if a in is why PATHFNDR-X the levels.We we it's saw where baseline of patients sometimes clear to over thing controlled Probably useful, very baseline everybody

R. Struthers

this and telling the for low Yes, rate the our that the is as we same ballpark. is and ] to not that studied we've PATHFNDR-X been that in trying, be in estimate sure overall, [ study blended you've and other remind people response XXs population a folks, been Cory,

Cory Jubinville

in we've looking inform used behind you versus least And of you've look at conservative across Can these PATHFNDR-X assumptions the given octreotide when to us rates mentioned group. outcomes? building studies you rationale your walk off previously previously the historically, study more Especially head-to-head -- paltusotine you've that the response that of for that's probably potential Stratum-X seen? study that through at that, you one

R. Struthers

and reference a studies one naive with the same also range. the of in it's population to modern close comprehensive the Well, using most modern assay and

it's pretty a vast octreotide but IGF IGF powering in was naive And the in I in our actually it levels So only levels the large And use patients, was good majority that normal a control patients. did analog, achieved of study, within range. of assumptions. arm XX% and we think and that reduced the octreotide, number

or had PATHFNDR-X that's so we powering where for Stratum-X the study. group And that of

Operator

Your next Baird. question from from Skorney comes Brian

Brian Skorney

about would mean baseline IGF can question, in to on the secondary was IGF-X following better say would reverse? tradeoff last mean response endpoint of that in rate, of but level IGF and fair primary characteristics and it just guess you a lower the where that are say And it production anything there's baseline, sounds of sort like baseline what PATHFNDR-X between a sort study? -- there's reasonable or I the higher is baseline lower the the terms

R. Struthers

have just another we'll month. think I wait Yes, to

see I coming. it, wants to It's Brian. than worse me. Sorry, nobody everybody know but

of And soon could part kind the at So that, really answer? -- end. there of soon was I a the answer. is I it lost that

Brian Skorney

of Just IGF-X the level? about if you could anything say sort baseline

R. Struthers

Yes, not this time. at

Brian Skorney

TSH to differences could and think get about? the to on you comparable something how where then you the the specific receptor? more be Is target. a Is And I wondering here? it have oral like agent a the an maybe as guess, trying any your And this seems to [ it handle along it's thyroid-stimulating moving to nicely. just teprotumumab ask capability follow-up is between about get do stage, to IGF-X was about ] pipeline think I in think receptor? to Just antagonist how binding hormone

R. Struthers

just about molecules. orally polishing into Yes, the good last that one No. hall and who already I of available, in latest Yes. the are we was excited few. batch of chemists And molecules bumped the the really have

since eye to eye that such develop of at getting people the we're There mouthful I receptor ophthalmopathy, talked so receptor.And to disease in disease the been people, Graves' cells XXXXs. pretty that caused as the the pipeline, root the our back in the eye.So, caused about for of block The in the results receptor. a problems the thyroid in think that by on by these hasn't problem. eye the and to TSH Graves' ton going of target TSH on on it's and the disease problem. back the receptors is this the formal close is that cells Graves' disease. that. new branded, antibodies hypertrophy a disease the notion then the but cause That's to is the other this we've binding is it IGF act receptors drug isn't root a more of the Graves' -- program. thyroid we're the And remind been is or And this to those And because eye. activate call antibodies itself name on TSH TSH people those Those just something it's protrusion receptors cells

you be can the world tooting or best gals, horn the best to here sorry, are think the replace, in molecule. in that that this the If drug trying think the for our already is And the you and down patients the know, yet we we we another a of of but and receptor I'm won't Graves' block peptide next if an a maybe we're eye block treat think with Graves' block trying hormone little -- getting bit, have you effective that. receptor drugs hypothesis.And, itself, disease. the at Graves' guys who it. making That's labs for hall I disease, are And small you guys in you world have eye that to some some like

going get it. So, to yes, we're

Operator

question Tsao from H.C. next from Your Wainwright. comes Douglas

Douglas Tsao

operational you that syndrome changes to sort there adjustments of III thinking understand, it really behave? help curious to the there of decision that make make curious, you sort sort molecules potential -- Phase versus an helps how as study, full readout? CAH of a starting study similar is I better itself just where sort look CAH -- are you carcinoid point, I'm of with from jumpstart, readout interim on that that the the about the mid-course getting that it would is we'll the I'm get, mean, Maybe just you that would the of, sort or

R. Struthers

information, our changes like that the all type begin drug SAD knew we biomarkers. to we ] coming [ knew we hormonal study. get and study, it's as the Phase Doug, I studies, out it's the and the by an the these of study endocrinology that pharmacology of we this open-label CAH was including was in core progresses And where paltusotine, in earliest with cohorts Yes, working did

we start and looking we're -- at about either guide we're to design.But with our outside So, talking physicians Phase group information our and this it, of our getting broader all of until it it we investigators investors, boards. disclose publicly, our to, be still with a can't we all the and time until or advisory III

to want that's we forward. it's able community a moving been talk -- to So, well. this broader advance be about And to program how and we

So that's be current it start talking why we able decided about that to next -- our quarter. is estimate we'll

Douglas Tsao

setting in most what focused you're clinic and ahead going candidate quick in thyroid just a lead cetera? terms on just I'm follow-up And at, obviously just curious sort are of you of of on into sort then seeing a TSH to determine or selection what the et the the antagonist, preclinical I levels, guess, on the select looking of I'm curious, your molecule? impact

R. Struthers

doesn't have polishing treating to right receptor levels then molecule, start so TSH normal. other mice remarkably. with make absorbed, an of and that levels But to like And the have little, thyroid a point corporate good a it's And we like oral humans finding the interested other drug really where candidates. were that time the give long sure of go them mouse In highly our those has we're at had those deck normalize XX one you're in the make molecules able go working bottle. all it's back, interactions, profile.But characteristics. hormone cause we've there's trying for molecule hormone to toxicology our you And on programs. I'll to where in much different optimize back towards you're up just if very efficacy, our slide towards potent a Yes, to orally good hormone levels we receptor. a Their antibody activation their XX,

about drug efficacy. But patients of the in the quite programs, study of type model. it's in it's I great with great many about same it's that that also do efficacy, I think said, we'll the an not relevant So, as disease.So our like finding efficacy has Graves'

Operator

Your JMP. Jon comes next Wolleben Citizens from from question

Jonathan Wolleben

me. from X

just versus is of label? has on then you and opportunity are a have think maintenance And treatment a and the seems the thinking CAH to changes well, if in how if and in a be a you in wondering XXXX Just could label forward moving about going paltusotine give you lot for still maintenance or been acromegaly like forward? XXXX some Cushing's excitement difficult Cushing's moving focused indication Are dynamics about CAH there. changing as context you

R. Struthers

which that to the wrong over -- think about receptor, address the the hand me it the body's things bad is And let happen. -- opportunity I'll of to things opportunity. to body's the XXXX when XXXX about and the endocrine of or talk addresses heart Well, stressors. commercial ACTH pathway, center in commercial the response then Jim go

adding in pressure, excess adiposity, bone. in a too with CAH increasing Cushing's CAH. disease you're we problem.So, you're glucocorticoids, So damaging out you're patients front It's blood or much were glucocorticoids with in excess

We thinking humans. have something This disease, an lot continuing might is to going with And ACTH we in studies. nobody ongoing in to a road else NIH else ever about we're in an the pathway Cushing's these and learn in what evaluated exciting study with And the we're that. the do down the world antagonist. work on we're about has

paltusotine and acromegaly. So on and for to maybe indications want Jim, expectations you comment

James Hassard

treatment. patient of are majority And on population Sure. an from patients kind the was think versus maintenance I naive. question the addressable standpoint, specifically of I mean, the currently

or patients, patients estimate new So in marketplace. enter naive any given XXX year, the maybe we

in of group is you PATHFNDR-X that that's are patients hand, maintenance the gives approximately that of data patients. So the XX,XXX that XX,XXX patients.And already approximately importance

However, label us are possible It's broadest PATHFNDR-X, of gives across in the differentiated the PATHFNDR-X patients to the the continuum. to that don't really from minimize again, because, want value address products marketplace. several

as some important just for indication we differentiate somatostatin data paltusotine PATHFNDR-X. than that the important forward.And move hope from additionally. hope I that So ligands We be there's us an will an it we receptor injectable will think more to glean from readout

R. Struthers

can demonstrating, starting the PATHFNDR-X, can lower in goes being who lower make communicate disease controlled. a and are level maintenance add In it control little them about better.And feel from visceral that maintaining were sick there's an improvement data bit, as a condition. was about condition in in a just to was I if their who And their amazing a something we're paltusotine patients them if help able all PATHFNDR-X, IGF as that with disease of all just patients the than well, rather symptoms, to levels,

very to so, excited And see out this month. how next plays we're

Operator

Your next Jeffries. question comes from from Ding Yuchen

Yuchen Ding

may. X I have CAH, We for if

week most lot week-XX, one, reductions surprisingly for XX. weeks at and not So data out just number AX are actually around There's X a at X. of to

change have of of some at others, a earlier So will can IIb time versus there the more who that we how report AX I'm How soon magnitude those is people Phase do curious to around be AX data obviously competitor AX you comment we but And on you will of in little can And focus out hear what absolute some points? I be data will from March. update in should after X from think week-X, are which do frame if level on? you maybe the percentage then reduction percentage given given data think QX? a competitive bit should CRFX about change question specific, already have you and

R. Struthers

Yes.

is. the best way to how answer Let's see that

treatment of off, measuring our time and adrenal we're period. throughout AX courses First study, other in markers the

So, they'll points be time places. comparator different at

signal, One arm day measure as systems so circadian call And where the not the of earliest some now make AX in things as it you But another doing fluctuate.And pituitary, adrenal.So of innovative days corticotroph study, of day, and an we throughout possible, my the the the going that that from the we signal or markers weeks, the I've around some blocking as career, have those timing other XX% molecule biologies. data informative the think XX% in says other by and understanding because important. goes the estimate that also and is make CRF that that pituitary patients studies but to been know, other this has into have the is endocrine we enroll signal Alan's just option into from ACTH. can probably AX reduce you I a that wonderfully -- the that things. since for like we really And is of vasopressin portion the to of there's on our by measurements what the exciting the is in in output of recent only we'd very interesting an a crinecerfont that at cells

X. that However, we're only there's And and which can mechanistically that's receptor, one blocking. at the its MCX, called way receptor that's melanocortin act, adrenal, through is ACTH what

would block to antagonist to in output. the larger a effect I if what a have is coming that effect have an ACTH And fully more much much on receptor, the So can adrenal expect -- we'll you AX months. know

So to think the had before. see receptor disease is super since antagonist well. and nobody's Cushing's excited known an that.And community as in about that We've ever But XXXX. I ACTH

the a it's advancement field. So in very exciting

Operator

Your from Oppenheimer. comes Leland from next question Gershell

Leland Gershell

on congratulations the been have that My accomplishments all made.

look now, annual earlier be to updates, know any forward we the or us Scott, you as forward from Just might to look perhaps of give the I just to indication some pipeline moving meeting long programs able on that forward, too to? of curious, if Society you're the not Endocrine want of

R. Struthers

That's And world and from pilgrimage annual the in the of going XXXXs. I've the I that meeting. talk around been together endocrinology. an about love endocrinologists latest to since get

don't out And think of final that'll the sending, be a you many presence us frankly a -- June. usual, for We be look large as list contingent. Boston the abstracts. submitting can we as strong there coming in I know this We're acceptances. abstracts, but will from I see

Leland Gershell

between had press a release quarter. the would to next Cushing's on XXXXX just these mentioned clarify then question, And readout CAH your be and -- CAH, X just

had that you in wasn't QX, may indicated we think I data previously Cushing's that mentioned. but see

perhaps QX? moved to have just going indication you wondering Or Cushing's [ be is there? reveal So ] might I'm to any if

R. Struthers

enough we diff just between time I didn't and X a discussions talking about maybe No, didn't the Cushing's. think do spend

see how let's So out. plays it

a any don't Cushing's But in of But there's on XXXX about something we is loss as fronts. great chance both. many interest of phrase in we'll interpret think things any subtlety I hear certainly interest disease. the way

Operator

for That's all the today. questions have we time

will back for it turn remarks. Scott closing I to So

R. Struthers

Thank us everybody, you, you. look support, forward appreciate joining and future. the Thank We talking your more to for you your attention, to today. in

Operator

for Ladies your to ask We conference and gentlemen, today. disconnect lines. you call this please thank concludes for your participating you and

Crinetics Pharmaceuticals (CRNX) 28 Feb 242023 Q4 Earnings call transcript