CBIO - Earnings call 3 2021 | Gyre Therapeutics, Inc.

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Operator

Welcome to the Catalyst Biosciences Corporate Update Conference Call. This call is being recorded. [Operator Instructions] I would now like to turn the call over to Catalyst Biosciences. Please go ahead.

Ana Kapor

Thank you, operator, and good morning, everyone. a announcing issued update. corporate we today, press our release strategy Earlier

Usman, Executive may the Chief us tab. Nassim and that Scientific today and website Dr. You release Investors Officer. company's access Grant and Officer; Dr. under the are President Blouse, Chief With

session. Following prepared question-and-answer will call for open our the we a remarks,

clinical and Before we we to or statements on actual implied operating in call this like from expected make materially to statements statements, regarding that are including those statements development could to results you other risks, begin, remind I actions regulatory These expenses. uncertainties expressed differ and cause contain projected factors would that various and forward-looking subject remarks that the and themselves.

are Catalyst or beliefs on change. call All time made passage based as to this events Future forward-looking cause of statements simply only. the may date of the on beliefs of made these this

risks recent you description forward-looking For on today. on place forward-looking most made our annual that Please our the a Form on reliance undue statements, not detailed statements to report XX-K. that be more quarterly XX-Q impact and aware refer these should of Form the report please

the Usman, other President Catalyst is and Chief the Nassim property call and Officer. any that, Biosciences, I recording, With prohibited. Finally, conference written consent this call the duplication to over is without rebroadcast Catalyst or of expressed of will turn Executive

Nassim Usman

morning. joining this for Thank everyone, you, Ana, thank and us you,

any success It MarzAA the solely to about clinical of trial. protease our or this and call is of Our complement discuss the to focus forward. based efficacy the is strategic not note platform stop today is on important going ultimate on decision medicines development to of concerns our MarzAA and decision the programs

Also, best completion the MarzAA recently assessment updated very expense. it based Rather, clinical trial not ongoing of in without through the the that several on study availability by these a to both difficult been logistical anticipated finance faced a approved prophylaxis increasing subjects could to that increasing development in which in based created a for partner. study determined however, pandemic financing and and that factors, therapy, we of to time factors, completed The a overcome several due has in it our of we continue globally. feasibility Due XXXX, to interest the be our MarzAA lines the and we strategic decision including slow. on challenges stockholders could or was competition is estimate late-stage we trials MAA-XXX not late time frame, to Enrollment Crimson-X hurdle were overcome.

our face As developing with a strategic portfolio. platform company we pipeline, an a either company company earlier-stage hemophilia to protease a continue a medicines developing MarzAA to diverse as pivot or protease decision late-stage complement

very programs Our in protease markets nephrology, address and large exciting to ranging multiple inflammation platform complement areas as ophthalmology. and therapeutic ultra-orphan and areas are from such

MAA-XXX the We stockholders. in and believe forward Crimson-X success to for the for our company long-term to offers of the trial date. plan report or data best this value the We that shift creation obtained

bleeds MarzAA events. thrombotic data treated adverse treatment-related has show will subcutaneously any or we The observed that not successfully have and

or to sell MarzAA We portfolio. and our license opportunities DalcA are exploring

engage resources us complement to search is headcount molecule in Halting candidates by regulation, through a XX% burn will tapped. complement moment. Turning of We that to as invest development for small approach be our rapidly protease Complement allow sheet protease inhibitors our XXXX. platform. high-abundancy cannot. differentiated develop and is and September and our is targets a with antibodies opportunity commercial advantage believe of partner very in key can million a us CRO to cost platform balance XX, degrade way growing MarzAA that and a reductions a our of our to starting our therapeutics reduce to that for reported medicines large cash allows we and one $XX.X and We while approximately that only

up in complement believe ultra-orphan from open settings multiple disease will large to ranging opportunities We markets.

with our development possible enhanced these our forward. a programs continue develop the strategy forward platform complement move that tremendous is candidate, candidates that we will our will license generate holds either to on We XXXX, going as I market believe We clinical the own. resources swiftly factor in CB our potential complement investing as optimal or subcu and from

more pipeline, Now give and Scientific Officer, expect turn to it you Chief term. complement color what I as will the call our near stands can today Grant in where Blouse, who our Grant? on the will over of

Grant Blouse

Thank Nassim. you,

current the by of other CB complement-related led and standard protease is subcu-dosed portfolio to is is disorders. complement internal XXXX-PEG, candidates, CB development and there no XXXX, [ CB platform. potentially our which care rare immunodeficiency a complement discovery XXXX originated where the Our of designed from back ] enhanced drive address both

CB candidate, activities We dry XXXX-PEG treatment candidate. product this product which to for complete to and AMD. transfer licensed Biogen the for in CX Biogen is our to the development we've is degrader plan of preclinical of Catalyst-supported

that's presented recently preclinical replacing the protease. subcu complement deficient factor in longer-acting its We potential therapy on an CFI-deficient data as indicating underlying I, XXXX, CB effective, patients, by

product clinical with submitting the factor study factor natural designed support history also We the follow assess I-deficient initiating therefore, patients on plan XXXX X deficiency of in IND CB XXXX I for enrolled the XXXX development subjects and complement and, program. with our outcomes an first-in-human and We ConFIdence candidate. in to this first trial complement the

providing are We technologies, candidate and our development internally. data XXXX. preclinical we expect to nominate opportunity our develop from in discovery generating next presented or our protein out-license last platform to from either month parallel, originating platform an additional In leads

Nassim Usman

over our staff, clinical opportunities to investigators last investors. everyone employees which in program impressive, subjects, now. decision the the MarzAA and involved complement our years, our you, been site in the Thank particularly The who and pivot are We progress trial programs Grant. validates and make several quite thank has study

our company. will complement questions. back protease Operator? With It We market operator, executing MarzAA the the day. I call is to hope to as we take on platform over and see will that, forward and one the look to a turn

Operator

[Operator first from Raymond is Our question Sandler. Instructions] Piper Chris with

Allison Bratzel

Chris. Bratzel is on This for Ally

I you to first, So think indicated enrolled for those you've study. CB on also, the I next program see clarify then Can expect the can like goals that enrollment history from X natural data how observations filing. clinical that to got trial outline to the And patients? guess, IND we history XXXX, find you in natural prior And your talk year. what on in the patients you first just to CFI-deficient early

Grant Blouse

Thanks. Yes.

Let me a parts. take couple that in of

-- history your and all, the I So works how was just enrolled. ConFIdence patients natural that get sure X so we've first are, to what ones going and the study question on what's the make them with first

study So and ConFIdence. ConFIrm, enroll they've there's parts. X CFI is the There's deficiency, which works that ConFIdence, they once then way which is in screening, identified a

to encephalitis. what recurrent of of This complement really bacterial factor on standard which have infections, them clinicians, allows autoimmune they're is, their these but by progress there care, of is their I patients most how treated their kind have us follow deficiency, some none for

be now interventional and we're how pre-drug do kind XXXX looking to disease we're able the benefits compare So when XXXX. where long-term able we of of kind of the follow to This on the to their absence in trials to start of they of allows board. back prevalence having and then us at

behind idea the that's studies. So history the natural

have that KOLs also we identify outreach and now an opportunity first-in-human in the year. in with our allow those to studies They us patients proactive to enroll search next

while now a study. then work standard the to is to question, this safety towards a -- the XXXX. all on IND is going second filing in and first-in-human be an we your of So part designed PK/PD so study, And

to CFI all parts then complement complement introduction rebalance for we'll single there? So looking as you'll for ascending biomarkers ascending single well follow first we'll for be because on XXXX, have that the PK, answer we and of biomarkers I. study, a CB end by biomarkers the be the to the of dose expect which which therapy, dose able of presence look and the given the dose, be to multiple Does and replacement data and is the the initial year in a your have ascending of able factor regimens is those of a

Allison Bratzel

that Yes, on milestone can yes. of the remind And the That's helpful. related any just what And And just payments? on us remind would you big maybe runway. trigger just -- partnership, second event or one. events to are a for that flow Could XXXX-PEG? cash the next that, -- you Catalyst

in burn a math, our by little million think $XX I the XXXX. has over been quarter a cash

$XX XX% a reduction take to So around million would that quarter.

quarters X you runway. that So gives of

any and that And So just I line X in the think, outlining over other or Catalyst again, thinking? is -- flow the with next helpful. be just -- your quarters, I would guess,

Nassim Usman

partnered the Biogen Biogen, Yes. With is that around which respect is to with controlling news molecule. flow XXXX-PEG,

So update step to on in much except the we their can street we'll for supporting them activities, I there's is. not them that IND-enabling more currently to are have say wait what next and

be the answers is And we cash X I believe? your from runway, the question that questions, estimate milestone of next Our yes, on approximately moment. With around that I what partnership the have year at entering we would your clinic. all to respect think

Allison Bratzel

MarzAA. and the kind Yes. just one decision on then maybe halting the just the process And of last for decision one, of just timing strategic

as September, have the and as maybe to in that recently target think 'XX. pivotal submission still I data for year-end by was

drove specific today. if just the enrollment? decision wondering that by really the last of you pace the can driven changed the X Or was anything that to like announcement of it months, just really over strategic So entirely there's point

Nassim Usman

DSM-V, enrollment that XX by to it's was to being XX the and in bleeds. recent last about you in to their close Well, patient patient months of assessment math, but for the pace because that able very we get it's mostly impacted if -- the do do it's that order through were the the it's the counts, long-term

part so out, the the we And was XXXX. when into that pushed latter of getting data mapped all

that's to with made what slow our to strategy. so And decision new enrollment, switch the

Operator

Raymond Timur next question Ivannikov Our James. from is with

Timur Ivannikov

blood just without I/II I/II of cannot that talk Phase along MarzAA in a And rare guys far how was that enrollments? terms in Does Phase disorders? that study you III work basically about Can -- Phase study?

Nassim Usman

at It small So PK/PD. looking you that not correct a was was registrational. could rather study that, are not -- study it

come enrollment be details not XXX that what's the did again, study. as take had the to an XXX to challenges. a with not We study But approval, of was we also the And capital the will And that sharing the just end. that study study out leading the we way was of along feel all stand-alone. it big without facing to viable

Timur Ivannikov

I'm analysis. just out for terms feasibility the think time And to you a think chance there this to not in you I how potential then it. much partners of sure wondering program a had whether decision, Got was reach Nordisk. was any I to Novo about already, halt. timing perhaps Okay. you've strategic the shutdown mentioned including had recent And

Nassim Usman

We don't but on business specific development. outreach, comment always any engaged we're in

Timur Ivannikov

Okay.

then Got in it so is not one will -- be how the remind factor causing just you a modified are, the of you Okay. program, more complement it. question just factor since it can on And us complement I confident I? terms immunogenicity

Grant Blouse

be and look So not with for CFI for that -- do molecule doing and we question, And regitopes. We look and deficiency silico. that We full process does with assessment its molecule. -- assessment do into drug its when, risk issues own confident look engineered to a very the life, for extended we any Timur. full -- how T-cell and T-cell don't these XXXX are if there's the at of that we We or is at the you and T-cell antigen-presenting fed the are they going feel cells a on we've to with And potential for epitopes. kind in induce response. of, in what the immunogenicity profile It's going will, a product on any clinic. done at thanks molecules half whether

XXXX on do So they're preclinical the can the concerning not ensure our that assessment all immune we all gamut of an well to be risk molecules as that in as would forward going response really full we clinic. developing

Timur Ivannikov

regarding of with appears Okay. of Got And deficiency, CFI ultra-orphan be the an it it. And question. type prevalence then maybe one indication. final to to

in back, I'm she know to a the But practice. KOL, extent few showed prevalence patients Dr. your months in understand several and Haerynck, what outside. her just to you trying think U.S. the I

Grant Blouse

Yes.

XX of got now. patients herself have with boots recruit color, We as that go deficiency. have with that and ongoing clinicians KOLs of of and Haerynck And CFI-deficient has globe these interested the Dr. right trials. little talking bit on us to KOL the we've built a ground the We've a partnering outreach network to cohorts across CFI And looking do just with for pretty for are in and patients the individuals. solid that trials researchers to forward

that content as is and well. continue of patients course, the quite American the getting we in North and, for U.S. So enrollment us KOLs and important

So we're definitely doing that.

Operator

question is with Sam Capital. next from LifeSci Our Slutsky

Samuel Slutsky

I just deficiency me in the remind from guess, where go data within and first, indication the after of there with then opportunity with potential asset. CFI general terms just just XXXX, SAD/MAD selection you

Grant Blouse

Right.

kind subgroup have We're of a population with still of SAD/MAD, has CFI-deficient bacterial about recurrent would probably without of after full vasculitis. have -- thinking So nephropathy. a advent be prevalence forward. about nephropathy And so a X a patients not another would be at the you deficiency. CFI, of Phase we patients. of a infections XX% CFI in the then And looking moving that or that's These

We have That's partial as opportunity in for later. well an those deficiencies. expansion

On would probably focused the the patients and for study after first be on fully SAD/MAD them. the opportunities the deficient

You complement in cascade. where be complement-mediated think complement the think you We natural in might of drive other back as regulator more it's CFI add diseases ]. XXXX, given [ as to can a potential there

And opportunities exploring when where to lie, those we're talk on opportunities kind we've now. of so And settled we'll them. more those

Samuel Slutsky

Got it.

the anything were in any this? Okay. And MarzAA on to studies lastly, then comment so of just that immunogenicity regarding ongoing,

Nassim Usman

all efficacy on soon. that we'll studies, the today. nothing results and share the No, to with completing along comment We're follow-up

Operator

Our question is Research. from Instructions] Catherine with Novack Jones [Operator next

Catherine Novack

partner you safety Just efficacy with trial And you that be able or to set the you'd do to buyer a attractive buyer proactive think data regard will conducted hand what aspects from partner? in it of was that? asset? the partial be have date, to that MarzAA to do on a for would share to looking And data the or how as a be when expect potentially you for

Grant Blouse

it then of will who share clean the we the of we'll still do have data take there things trial. months data, have And trial are to course, a we because Well, to safety be couple that are patients the and down wind mandatory to the publicly. in to for able

do So respect that our a of With expeditiously finding sort as possible. general we few as months is to guidance. partner, a will

Catherine Novack

clinic, CB you degrader the then development are is of And program prioritizing XXXX of the it. the terms Got in rest in complement complement of programs, in after the in how indications? terms

Grant Blouse

Yes.

great good, So question.

we So I a to mean, next want our successful what we're we're going as that looking candidate for year. in indications the nominate molecule is next obviously that with most development

we're when inflammation, indications the over those really, the we're disease as identify modalities protease advantages opportunities are have But and go so at nephrology areas that market approach differentiated such competitive market looking the think to indications. prevalence we, forward. where trying both we targeting where our really current And we will in in also

for And whole global the at inflammation. looking of medicine is really, kind precision approach. aspect focusing opportunity, that a protease of of the on the and we're nephrology really platform we're matching So areas going forward

Catherine Novack

Okay. question. last And then one

to In the terms CX Biogen CBIO-supported of degrader? the of left for collaboration, activities complete what's transfer the

Grant Blouse

CMC so IND-enabling mean, specific well development. as before to what details is the certain activities, we studies don't really responsible about been the we've we've I talk XXXX-PEG for that with as spoken program of but publicly

Biogen So to then are when our over complete, run part of they're those handed packages internally. for with

Operator

reached question-and-answer We call turn and the will for end over the the to closing management have session, now I of remarks.

Nassim Usman

on forward to today. us for everyone, you joining updated our progress. We keeping you, Thank look

Operator

you time. for may disconnect concludes lines participation. your This at you today's this Thank your and conference,

Gyre Therapeutics (GYRE) 12 Nov 212021 Q3 Earnings call transcript