X4 Pharmaceuticals (XFOR) 9 Nov 232023 Q3 Earnings call transcript

Greetings and welcome to X4 Pharmaceuticals' third quarter financial and operating results conference call. [Operator Instructions] As a reminder, this conference is being recorded.It is now my pleasure to introduce your host, Dan Ferry from LifeSci Advisors. Thank you, Mr. Ferry.

You may begin.

good and operator, you, morning, everyone. Thank today's Dr. on call will Officer, Executive Chief XX's be Presenting Chief Officer, Ragan; Paula Commercial Officer, Chief Dr. Medical Mark Baldry; and Arbet-Engels. Christophe

product prepared regarding Chief Financial call, statements be Officer, plans, the as Mostafa; open on development Chief and we today's Art by the regulatory Mary Adam be to making research that subject the XX-Q, Taveras; DiBiase.As to Paula Officer, and be risks cause and reminder, will which Chief your will questions Officer, call be filed well is forward-looking Following up with These by turn joined Paula? and Scientific the remarks Operating close statements to and each, Description company President CEO, as call filings Dr. risks activities. recent uncertainties will differ a forecasted. from expected now can to of SEC, most these like market to may those over after including Form results quarter's Ragan. today.I'd XX's XX's in to found actual this are

if quarter In that here, build for in this, up Dan. have of today.As X anticipation our date, set week XXXX thank be and joining highlights, call a fit-for-purpose launch first was NDA, The on approved. and to U.S. the has the Priority primary April quarter by XX, or the will which XXXX, for mavorixafor, which us the I'll action focus our the you been To organization. continued Review. a seeking our you we for treatment commercial of of approval of if it's accepted of recent can out a period XX, our discussion potential WHIM great syndrome, lead morning, our and candidate, drug which FDA last sets the PDUFA, news start, FDA second see at again productive Thanks, us today. events busy be very the for reviewing everyone, culminated in of Good third our and Baldry, WHIM and aim U.S., Mark subsequent advance and activities now eligible we through date, a the run XX of use mavorixafor to a the syndrome launch readiness Officer, is Neutropenia of the details the to which obtain to XX Commercial have approved, Chief pre-launch receive to Phase either Review understanding of our will to further X some of all remind do mavorixafor sell that on mavorixafor's designation another physicians continued enrolled here and due drug to diagnosis. that our to study rare and more in PRV, now Chronic want or both the Priority or Voucher, for sponsor.Turning to is Review benefits trial. our of we everyone to We pediatric to early than syndrome educate patients WHIM Priority have can for program, disease in application importance participants

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with second be we between of about in medical leveraging purpose. launch the here have believe to these the a Paula? work an up and and launch the highlighting head future supports developing We've launch developed conclude we've syndrome back commercial by discuss hand going in experience, ramp rare organization leverage for like potential all much synergies been fit I'll Paula reimbursement of go-to-market will hires as our would Chronic U.S.I across building functions, truly many in disease in treatment We ongoing to whom that efforts expect quarter made opportunities. our the program Neutropenia, WHIM Chronic it CN.And commercial as in of anticipated discuss of for of significant and we the points investment we're We the and finally, forward.And more successful towards to to mavorixafor development and begin XXXX WHIM through commercial if we relationships that's to the now, Neutropenia pricing CN. an commercializing leadership key and

of summary need in we patients increase all enable launch and so WHIM. our support disease efforts much, to earlier in diagnosis Thanks towards our of great Really Mark. awareness, anticipated head as

robust of year we program.We ANC their mavorixafor, enrolled therapy. make that biggest a to Neutropenia responses event well Xb you Let's the we If an is, investor and where change held be Chronic the results. dose patients achieved XX helpful and here living would our on remind of it as that needs At gears those and single our recall, what people would with XXX% little focused that over ago, now shared serve? of initial and CN from a bit difference on Chronic Neutropenia that a greatest the are time, physicians, trial focus background to everyone regardless we thought Phase a

formulation insights where new Additionally, of for attributes product physicians included from patients needs valuable the preferred administer and to to populations. that their these from that time. is oral our or interviews, safe, related of an tolerated take, we already durably increases over treatment gathered demonstrated they a as a number CN. one has across Mavorixafor profile highlighted easy and well and potential Their ANCs attributes

our the is Additionally, of across over metrics mavorixafor neutropenic that also were and increases, where safety taking Chief direct decreases key of WHIM clinicians' Phase Arbet-Engels, ANC to status this to X reduced, decreases update on treatment importantly, associated criteria durable CN Christophe share promising CN translate study it program. the use.I'll new Christophe? rate, beginning into now patients' evidence also includes the and helping Officer, in of challenges and of meaningfully successful trial, therapy for CN reduction severity evidence to X an the chronic the toxicities provides benefit a could our and duration infection and build Most lifelong community. that burden infection pass Phase with a patients GCSF Medical GCSF.Our

Paula. much, so Thanks

or As evaluate ability of our trial launched GCSF treatment. term. evaluating of or trial, of of months neutrophil we to you The mavorixafor Phase raise ability patients possibly reduce use GCSF Phase clinical completion assess without successful mavorixafor's know, durably Xb a the and the CN dose in a is within with patients, absolute same ANC, mavorixafor ANC dose concurrent whether their study single raise patient to to following population the X designed first in longer chronic to count, to the few or could eliminate see

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of poster with in set successful the presented the withdrawal Importantly, a acceptable on annual months trial or data subjects in GCSF enabled also decrease combination in X The robust the ANC has some patients.Mavorixafor be GCSF. the demonstrated dose in ASH full safety early in an response at will complete the meeting profile these the of December.

for to data and as us the the global provide we've X completed which a studies, we cells GCSF clinical innovative adjustments stable pivotal oral XX-week autoimmune we on comprehensive least Participants with have included to population. on to will Chronic be allowed our study required at inputs Phase interactions congenital we has trial an I'll or Phase in detail duration, placebo-controlled less study only than per and addition, microliter present of CN, far aligned are regimen with Neutropenia the in are in that We've has of to to advance be with idiopathic X on current GCSF initiate Phase in by be history the FDA the trial. dosing positive insights X,XXX mavorixafor current as the a able the participants multiple will as trial can have FDA, in and given prior trial during concurrent half little XXXX.Most The The XXXX. a infection supporting to for the confirmed WHIM rate the first inspired have X as safety quickly will this track importantly, in and therapy.With seen on endpoint, intervention The in remain XX we be treatment. trial, as impact during global, requiring the the ANC our to response. WHIM is pleased entry. to update now to on demonstrated medical more the trial a currently study The will reasons.Patients the design. the participants in half a our clinical or an now remain date of dosing first delivering months infection mavorixafor designed XX forward randomized double-blind, patients, GCSF demonstrated without X-component from at across In of rapidly expect primary positive last annualized trial baseline and from ANC success with assessing all towards thus CN X pivotal Phase our dosing well same move and trial of a

identifying will a endpoints advocacy and groups existing fatigue, will severity response able to of to assessment trial. safety. to determined the who FDA used to the CN trial we site, to centralized leveraging back it adjudication We've Infections annualized X the now XXX confidence, we infection first site Tom advancing successful approach assessment identified pass quality further By existing XX% confident already achieve assessed patient Phase equal in participants endpoint. activation of that to months.I'll the CROs, and Fleming, of rate to pivotal well large we global include be same globally achieve and will and our pivotal infection blinded infection, the by XXXX.And Prof. an to patients we study.We're of a our potential with of use, greater in for biostatistics selected the protocol each Phase have adding size and finalized, through approximately working advisor. now our or with than be the participants believe in enrollment positioned have patient global own the power for antibiotic pool the registries, initiate With the life half we towards are align trial WHIM begun are in and be this of full duration Secondary efforts for a X committee, XX trial ANC Paula.

are future Thanks so the so clear why we about our our Christophe. We from much, company. excited hope today it's discussions of

Phase We have set data in maturing study. robust X our a CN

that, look and for in forward positive to launch And look Operator? WHIM Given trial. global are and are questions. underserved a continued patients. much potential all to approval clear pivotal option, accomplishment syndrome finally, of FDA potential the we periods hand We first our we'll we now the the very U.S. growth guidance, delivering data treatment the launch.We open for years.And a in of your potential needed gearing with much for Phase of call the the subsequent in and up group mavorixafor, a coming forward of CN X mavorixafor up to this of and headed

first Privitera The Eva the with TD of Cowen. line question from Instructions] [Operator comes

heterogeneous intolerance they're wondering if inadequate talk the could their to What you reasons population response? it sense is. are to inadequate of are I neutropenic. but mostly was have due patients this or patient on trying response? or I about other still Is a I'm how guess reasons, the refractory GCSF get CN who for

will question. some Christophe, CMO, excellent that. provide on an commentary It's our

mutations do X with the plan this the the population. these congenital --within We to congenital patients reasons. Yes, and are Phase and there's varies thanks. if GCSF in response Obviously, a patients. patients, our indeed There different genetic have is those very in with Yes, have idiopathic study. heterogeneous neutropenic it

defect different in in address maturation So, may the and aspects GCSF the see all can not some neutrophils, a these patients. phenotypes of you of the the have

to Even we Maybe even given tough levels. around are add, of take. study the recent happy an we've GCSF, respond some treatment just and clinicians difficult considered patients tolerance when very to oral for what how excellent is, therapy, an to these from of to had they clinical meeting, it's heard a can be our some

building second the you all trajectory expect WHIM, based bolus to your just market you patients efforts look? And do in a launch? on expect how commercialization at WHIM, on Do and launch of

the us patients Yes. physicians with date. WHIM with actually of about prevalence been we've given And our had actually level patient continuing confidence engagement in really with U.S. We've to groups in it's the estimates X,XXX pleased and of

the will patients foundations launch to building the that approval. we're a get as possible after So, product quickly for as

Stifel. Next line question of with comes the from Stephen Willey

whether And additional previously are X. then, I say guess, or the the how at you you online you had you've sites sites brought said Can in were many think X? Phase X? around I you not, planning for Phase any

Steve. Thanks, Sure.

there's hiccup X. on little have X, the maintain the some Phase a it have those which did with now X. bit But we good We in XX-plus So, learned pleased very is lessons could enrollment. we're patients We at of why a enrolled.

But some a have us for that. share robust And data great it's X. we'll So, prepare Christophe Phase will a the to more set. lesson learned on

Yes.

PIs of So a Phase the from study from to we've X the lot X We're apply study. to going the Phase learned those the and X. Phase

exactly in ex-U.S., the with time. with the and we're of the expectations sites proportion to are match plan going large We're we feasibility U.S. seems at We the that ex-U.S. identified the and our patients enroll and to tracking evaluating are. number what -- a We've have really of this in to confident. U.S. that

we're study. this X confident enroll we So, Phase can

had Yes. sites, XX just for using Steve, give you we And numbers, think to benchmark, a around maybe rough bit I little of just a WHIM.

patients CN. about Xx as have in We many

that enrollment. many exact So, X-year the We're Phase you number but numbers, we be as to definitely make going to those it's sure for should expect sites finalizing about a still X hit robust trial. Xx

That's that Neutropenia, And that all? there then, guess, way in you Chronic I protocol subjectivity? X the at to investigator to going reduction you're withdrawal? is that just how are quantify respect then, with Phase a statistically Is to GCSF Okay. And helpful. standardizing try

Right.

variability. patients, lot of So, and know, is GCSF, prescribed you there is individually a to as

if want asking the adjudicated of to effectiveness to we're modifications a and establish committee the trying enforce reasons, trial. there that going under treatment the to we're Phase GCSF for stable XX so X goes of example, we're if ANC their only is We're a safety in event. to going maintain We for remain high of placebo, too mavorixafor of our versus stable. be to for patients or this. going So, But weeks allow to the blinded safety

question Tenthoff line from Sandler. of comes Edward Next with the Piper

Two questions, I if may.

if this, Firstly, mavorixafor? patients, submission the words, will the data just because I extension I I there correctly, think from heard those WHIM? should time mentioned, Could work other there more I the question, then, in are of be is know done on think In but abstract you open-label being patients be that presentation? any additional you there X on currently patients more any actual And there patients and second ASH. between X

Sure.

do just is quick WHIM on I'll that. a summary So, OLE The ongoing.

We in expect to next present of data the on that year. half first

moving and enrolled some So, are who on on patients look the placebo mav. on and mavorixafor updates forward to sharing who into long-term we those

that. in the have a tuned next terms year. And first data our patients is really ASH stay the set intent those we sure in patients make So, robust half around of to of for in then, poster, XX the X

stay tuned for patients fulsome on well, X-month But tell a to drug I really the that data the patients, as so lot GCSF. information story those X think X those we're new exciting around is Ted. that There's looking of the how will forward acting. on amongst presenting

the that. of you I'm in patients know rolled Awesome. over. I patients are can majority How looking OLE remind me, to the Great. And for WHIM? many forward

when haven't data updates. certainly where the given is of over. at cut but Yes. think I'm rolled them that I but the XX%-plus be cut this we So, not point, And any get sure we'll updates, disclosing we actually

question Securities. from Riley comes with Patel B. Next line Kalpit of the

a This next is that there's Andy you the Are timing Fleszar give be additional patients, on able on update comprehensive the certain amount results? the any the XX before you'll of follow-up or for presenting for for of looking granularity Kalpit. to if

go ahead. Christophe, Sure.

an some more is to and in I of manner study this. X first that all help that next largest remind X have It's hope we different a you important ASH it the study. we Phase the patients are to a seeing comprehensive those going months' this ASH. see data we be will do preliminary number at we we No, X-month of data to and we in information, of poster confidence those want continue to share analyses. year. open-label, data will is see in of half The the could But the Yes. so raise preliminary the

And to Okay. follow-up a enriched the to X CN? anticipate idiopathic Phase as then, or congenital for data do you be cyclic, that,

No.

of design robustly for we're doing sure we're I think the that all-comers Phase X GCSF. is the making seeing, we're what that our there's X, responses incorporating answer, Phase study and around obviously, then course, to because questions trying any X is there's secondly, question longer-term

diverse in a need those no That's we including numbers any population categories. with why answered. questions pre-specified are those to of both be So, of

more one what [ patients us. that might can on like speak then, level to color research, clinically ] provide meaningful but from about Obviously, And be what and look GCF of sense. better, market any is From you reduction reduction is makes helpful. question you your That would final success can prescribers?

the question. some is, excellent poster an That's be ASH come around that And very question. answer actually our because we'll providing exact meaningful research to market

Sounds to forward great. you seeing there. We look

Next Cantor line the Fitzgerald. Kristen with of Kluska question comes from

which, finalized Phase successful. WHIM, design, course, trial at CN you ways, looked in mentioned, what of like look lot as your for was X When of study does it the really mirror I a

to the you WHIM? talk in particular about study? that think you in you thinking about be versus mechanism this any the gives And subset differences this So, can of how confidence really related we patients should

No.

our the study, very of consultants, worked closely him. one with have we FDA, So, in that Tom from designing with Prof. Fleming

sample We achieved, primary we the we power have right the size. are endpoint be for confident to our and that have

study, populations efficacy placebo, that to And that randomized, including we're effectiveness, double-blind, able we be and the have be will establish on a which patients trial is in the monotherapy the of We versus X to the controlled going mavorixafor. GCSF. because it's

the received. study FDA from that from and in also requirements We the we incorporated the that feedback

positive And so, this all in see to believe and recruit we X elements Phase we the study. have data

to saw just reduction on took maybe confident. And which those plan across the X, why the to is reducing remind X, WHIM populations. we the actually for patient folks, We about Phase that a XX% in feel stats conservative Phase very fairly we approach, even a

nice so update. now how see factors in the for think uptick maybe expected, it's that this helps you like this again, where [ about Phase uptick, that seasonality. originally -- And things ] X? what planning some to in And slower you've are talk was of than for also you enrollment this the seen Can

sure. Yes,

a I challenge some younger wanted expected. is just think downtime, fairly the is, of out The tough in think is Chronic the trial every biotech patients enrollments Neutropenia. sick nicely. a for learned I field we especially certainly have what new such this summer in as they is as But We actually trial there, trial, but have patients. for to picked up enrollment some

a heavy operational from are importantly, lift. Xs Phase They're different More very Phase Xs. very

robust patient nice coming your on that board. a patients to that have a create large sites. actually We already the to sites are with start want pool to waiting of that pool You co-localized with identified a quite very are

So, we with certainly hitting enrollment that to high confidence. XX-month forward look

line the comes Ramakanth H.C. question from Next with of Swayampakula Wainwright.

have A questions been my lot of answered.

you looking maintain that size get of as And we application so the label? that so broad progresses study patients foresee for a looking trial the the Just populations increasing do into the in CN also, you Phase can X either once label trial individual you number of in these get what's disorders, into the stage? certain you're a the

label we the see for trial. this in that GCSF, the for previous regarding populations of based addresses we should So, that reductions include a the example, in infections the on patient label, label

the so, with And label we haven't FDA, happening, regards think is this the obviously. could this finalized yet reduced But we be looking we're rate.With at and infection what to...

then, Similar asking covered label GCSF, were but was the he think variable on to I the based it's the kind patient Yes, catch-as-you-catch-can, And of subpopulations populations. about all just subpopulation. inclusion.

trial is for powered -- Yes. primary not the And endpoint. we're our again XX%

size. and size, executed to study able endpoint we planning have confident current our So, with we're with should we're primary that sample sample the planning be not -- to this hit the we're

Next Bautz line question the David comes from with Small-Cap Zacks Research. of

for I'm sure at is, for typically And I ends to are I'm correct population with your doctor reaching guess that outreach diagnosis the one of type question the you're how me. trying up Just what physician you WHIM? curious get making program? what

It's patients question. have these a great their of of symptoms. a disease, presentation Yes. diagnostic the different depending on And because journey, journey, the variable

hem/onc. immunologists, So, under up end the some the care and of or a the a under some hematologist patients of up end of care the patients of

data, approved, patients we've So, few these on this really is for have the with key so likely most focused about been and complementing looking the at engaging are that past physicians which with get is we to We've the our also learning who months what once is an institutions been I this where our we efficient about know efforts. the prioritize digital extending And of our earlier in marketing, to way talked presentation. reach. this

to Ragan like now for session. comments. question-and-answer the turn closing I would floor Paula over today's to concludes This

very future exciting progress make day. as today great continued we much the as to a for joining providing look We Thank our a company. the forward updates call. you in Have again

you. Thank This today's concludes teleconference.

participation. your time. You disconnect this you Thank lines your for may at