Earnings call transcript Q4 2022

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Operator

Good morning. And thank you for joining the GlycoMimetics Fourth Quarter and Full Year 2022 Earnings Call. At this time, all participants are in a listen only mode.

Following the management’s remarks, we will hold a question-and-answer session at that time, lines will be opened for you.

I would now like to turn the call over to Christian Dinneen-Long, Company Council at GlycoMimetics. ahead. go Please

Christian Dinneen-Long

is of we available results Today, available December our updates this business XXXX. site company's the the Good being glycomimetics.com. at the webcast call. recorded. will quarter be financial This morning issued we for press ended on replay phone company's for after and in hours and the The Web morning. the will release review available replay full XX, dial-in is XX section the be XX site. The Investors days call will also A for Web close of year

call me Executive include on based current today Officer; Joining and forward-looking from expectations. Chief Chief our Hahn, Harout Today's Financial Officer; Semerjian, Chief call will the Brian Rock, Dr. statements GlycoMimetics on Edwin are Officer. Medical

regulatory the statements uproleselan, with Forward-looking product of uncertainties. regarding company's limited include, programs, not or to from along potential pipeline any operations, activities, statement. are and of collaborations assumptions, position. may about and expectations statements development our cash of no undertakes management's potential statements revise intention involve or to, pre-commercialization the statements represent clinical activities, trials, but conduct and Such or today our judgment risks our strategic update planned other and data our candidate submissions or obligation GlycoMimetics interactions as forward-looking our

our filings through SEC, risk the or concerning site. the factors that refer could with information to company, are For the Web the available affect which our SEC from please

the Harout. over to turn now call I'll

Harout Semerjian

three trial in needs. on our patients to areas: important we first, second, poised our evolution team support morning, with everyone. commercial continue through to on our commercialization; to In deliver made Thank strengthening we essential key areas. strong ever. patients cycle, this as are more have is a we and aspire raising I'm and our significant stage you, continue leadership Phase great a significant capital study longer. final company's sustaining to as that the three XXXX, good uproleselan; organizational III in focused we third, clinical say progress point deliver unmet commercial Christian, clinical of strides company live made strong analysis crucial leadership aspiration, To than progress pivotal for to continued to medicines in to become and life proud this At all

We highly Rock new Vice Officer. Rath Chinmaya Dr. as have Chief as and strategic recently, Ed as Business as experienced the through guidance most leaders, development. critical Chief Operations; Johnson regulatory of capable Commercial Technical late Chief advance Officer; our we Deepak of clinical hired provides including and Edwin Bruce as stages Kuvari Medical President insight Officer; and oversight,

in expertise strategy needs stage uproleselan. of over to programs. and we API deliver educating and market two need. if parallel, While approved, and preparing the on the uproleselan's the Deepak validation readiness supply well for early Chinmaya team Bruce his from applies In decades and our biotech mechanism pharmaceutical and driving his awareness oversee unmet hard of corporate action, companies of as remain pipeline work differentiated at are in relapsed/refractory recent leading commercial patients the his positioned completion of key planning to ensure to activities medical batches continue uproleselan, and following team AML commercial to

currently that AML. Turning than live study In III the to up leading our to to analysis primary uproleselan study median months, which follow XX longer study, pivotal area, than of to our is key Phase continue is second prior our in of expected, patients execution remarkable. greater focus a this relapsed/refractory in

to events, this occur relate based we slower follow is Last may of longer need first event to currently possibility benefit accumulation from fall, As events address projections that a on survival therapy. on reminder, uproleselan to duration the study this expected ethical slowdown XXXX. half the in final based trigger the survival reflect in survival of recognized up an that

medical analysis, preparation our the to for concerns. approximately survival Phase analysis to planned database of pool order independent analysis interim team study employed originally aligned blinded partnered the the The conducted an final year noting a integrity of integrity on this experts no recommended interim statistical for very events. with III trial protocol high while threshold of The statistical Following lock. we how to interim our the at in cleaning consultation analysis. planned on XX% statistical data data, Ed monitoring clinical planned high ahead with the interim In thorough final the the used threshold survival context originally continue the the February will in we and which call, in with this was ensure preserves at the final preserve analysis FDA utility Later safety XXXX. the were to overall there of provide additional data this committee in community analysis final analysis, establish

As of earlier, noted uproleselan months. currently greater XX for than follow-up study is median our

the as than of studies median to at to extended study this time the analysis AML relapsed/refractory our assessed have we potentially Given at primary continues follow-up study any in relapsed/refractory mature, is three longest it analysis. of have randomization more for track from To point other to follow-up on primary years. duration, AML the our knowledge,

uproleselan's of median fact live the demonstration to profile by previously remain that patients in uproleselan's in potential expected. study and the duration continued follow-up optimistic about and longer than We of continue this are light our encouraged extended safety

Ed, our you to analysis the our more funding Finally, potential pivotal call, on we pass recent announce our by and relapsed/refractory well Rock. our in of from the investor we're share be a today's pleased study Ed science in I'll encouraged support the of clinical to end and base, and recognizing III runway a that organization III Phase over We're On Phase we XXXX. pleased received Hahn; CMO, study interim is This $XX.X Dr. our to which driven CFO, financing, February other to to to developments. of joined positioned the detail million extend advancing expected study programs. completed AML. continue I'm is cash it uproleselan ensures by Brian to

Edwin Rock

Thanks, Harout, our joining everyone for to call today. and thanks

mentioned, Harout relapsed recently of interim and completed our remain outcomes. concurrence, high to As modified an designed III high sought uproleselan stopping in by flemming stop prolonged to this statistical conservative analysis AML. early to a of This intended we study a analysis could had trial With up for population. use that to FDA bar refractory have whether observing we to analysis Interim obrine method been due uproleselan generate be early. threshold survival benefit utility Phase for follow the encouraged assess the interim the two we

evidence positive of benefit. planned XX% based result the represent itself of First, by would events uproleselan on survival compelling

primary if survival the study the the then analysis continue XX% of preserved subsequent to also known Second, be of statistical study's the would final about as for was endpoint. significance, ALFA,

for mentioned, XX% analysis GlycoMimetics two As final the analysis of the ALFA or the designed were interim roughly equally implementation as study. the use the about not used study. and planned wto of in analysis goal total mind, interim on shots available those about of gave is uproleselan with rest, available ALFA to shots Keep the X% XXXth

X% ALFA targets aiming with these to analysis different So about target shots used on two at of goal small. interim was for are very

the the to analysis, statistical class original remains the The key study of is toward in here Blinded final demonstrate boundary that AML. uproleselan first Conversely, closely prolongation pooled data as much as more Phase trial. utility, possibility the a candidate the with the the in aligns part transplantation patients XX% analysis that in a clean designed protocol. I/II original takeaway with matures drug trial is in observed to broad above potential the survival safety transplant rate rate profile study and show preceding the

leads in rate providing analysis, half in on projected currently study this biologic to rate a the to overall relapsed that longest now improved expected is to seen transplantation, at gives analysis at continues forward observed knowledge, more after possibly dropout study through any in three This shortly our trigger more benchmarks potentially treatment AML confidence of that we to not first in to the its other and and In relapsed us reaching X%. summary, loss stem our live We AML years. event remains final of patients look in To dropout more is historical help resulting time survival. study population to durable to trial. than up AML patient overall than follow Rather, refractory cell the studies. our on longer and the slow of uproleselan contributing have trial could XXXX. events bridge track survival disease follow about based of refractory survival hypothesis Additionally, that to remissions deeper, up final low accumulation this primary occur

who care options and primary monitor on to continue we highly a waiting continue closely. GlycoMimetics, new for this therapy new for we accumulation addition, patients delivering of standard focused At disease. In lethal event remain to better

Now an hand Brian over financial I'll results. to of overview for

Brian Hahn

Thank you, Ed.

of company. had potential as same XX, III million] December for the million Company's the general December XX,XXX,XXX the of million XXXX. a expenses expected as fourth for for expenses of in for XXXX. in the as filings for net value clinical second stock $X.X compared of approval $X.X uproleselan proceeds to Decreased fair sales February million XXXX, XXXX, awards and Expenses XX, the compared the patient $XX.X proceeds. our fourth as advance to for existing uproleselan of Phase issued of prepare for XXXX. facility, company's pre-commercial XXXX, the As in cash to over and expenses primarily quarter market runway to for higher half to clinical marketing $X.X and shares cash quarter due decreased XXXX, to study XXXX. commercialization to under of were quarter for equity the of to From the market primarily GlycoMimetics XX, of grant $XX.X ended We XX, resources million we first November to million common our date million development and into million of a continue [$XX.X use development equivalents administrative $XX.X the to evolution quarter lower of end the XXXX development $XX.X of and plan additional XXXX December commercial December to as intend our uproleselan's [XXXX]. total GlycoMimetics by increased enrollment due research compared ended lower to to until XXXX costs the the raising compared at of The $XX.X cash million offset and global in extend expenses XXXX decreased half ended XXXX. as are period stage in sold These capital to regulatory

to Harout. back the like now turn call to I'd

Harout Semerjian

lines our analysis. of more its years. calls to the this and Thank updates study company AML who on need it is our the III trigger Patients look commercial financing, knowledge, of than new positioned occur GlycoMimetics. to recent the We're treatment, Phase analysis now at at expected I'd follow exciting to future we with for that to you, million Brian. up in final study study $XX concerns to them to sharing time most. stage are we to of three no the become continue analysis of patients to recent you This longest is the to longer the uproleseran Operator? in any the of relapsed/refractory XXXX. expected delivering a and primary With as was point final medicines live to to very study like first study well on found a we open And with the half track recommended important encouraged continue events interim our Q&A. work potentially capable have in to than forward continue safety

Operator

[Operator Boris Cowen. first question Peaker Our from comes with Instructions]

Unidentified Analyst

This Boris. on is for Nick

ones Just two quick for me.

you partners with your Phase a are sponsored in GMI-XXXX, pushed delayed trial for III? Phase And is to similar looking it expect setting, start NCI frontline or going trial you this for will the or come then assume reasonable the are it the that? the I be to a planning what's to slightly on you back to with out, do that when For second question collaboration data is

Harout Semerjian

So your second maybe your one let one me first. take first --

June it in about on So we're and finish line. doubling this down IND last very uproleselan potential we're you excited as really guys get XXXX. we year really the to point, At on back XXXX, recall, across have cleared the of of

at definitely But So are appropriate that's then if But this there's possibility. an there is a partnership really if on uproleselan. we communicate changes, that. point, always we any focusing will

the an Regarding as NCI, question well. that's excellent

Phase patients. And of a trial December was now, enrollment until intent endpoint adaptive that with idea sponsored II and time of II there one the portion frontline fit for the And for Nick, the an we XXXX the as NCI trial updates the there is As was everybody XXX -- rates March there enrolled primary was as the supposed EFS knows EFS after Phase at that of end that this a from on we're we this EFS its an in is call, chemotherapy received pause were the in any year II/III. the Until Phase the in an was to and get NCI mature, not that. to enough was XXXX. and have update pause patients

has to similar the just originally are coming was reasonable the which us EFS is So probably where be thing because your kind rate seeing reasonable? in that shocking We that something to question, to it thought, is update NCI think is happening. that not to be III. same to rates any think trial. Phase the But think it officially -- that's is on the it But clear, wouldn't not the communicated of at we're reasonable

Operator

Jefferies. Instructions] Roger [Operator Song a have question We from with

Roger Song

us. questions from two Maybe

what or you blinded can to add, statistical or you're the the the data driver us And MRD or give how some pushing of color have or For maybe, rate in keep you for OSC event transplant predict team, can understanding team of the your changing the been Harout, data terms probably seeing negative dropouts. the kind you timing?

have? a the model us give around just predictive bit maybe you color of So little

Harout Semerjian

communicated, into with our takes previously what external different worked the patients we in. statistical projection subgroups all have robust the have tool consideration a to as that events, are partners So of

we outlook. different MRD As an know, if it's positive, an a versus you're negative MRD

If patients versus transplant you're different see you'd a not, a outlook.

late different versus If outlook. early a an patient, disease it's relapse you're stage a

and in Phase all we from this beginning, when took just we full the our trigger characteristics III communicating started the previously compare these would the be. I/II disclosed build So had well it model. with And we to patient that different as Phase for projection the event

XXXX. even you then, year XXXX. If in November -- were will we might beyond projected that end well, data be when recall, patients From enrolled this was back the full

were that the from If the data were six, telling recall are live you that time, what at would months, should we AML get people go. before these although, that. around we us, they typically seven many get But wasn't patients, from relapsed/refractory seeing so beginning,

we've we're projecting. been pleased very So the way with

of we events we as data as was the projections the is we what And projections market a mature, to update those as course, and previously to curve continue between something whenever matures, at, was difference event communicated look our communicated. carefully there

the one operations happened interim team well the has did the at really data cleaning. that analysis, good clinical as things So Roger, is job in our a of

go preparing for would passed. threshold we can interim ready should been imagine, you have been As an analysis, to have that

we're database robust very now HX a our what be XXXX. And is updated saying have database also we and where we projections now. to robustness, within on based So that going

AML relapsed/refractory see has the remain this longer is Obviously, what and other NCI data, live good ISTs exactly by is your we continue thing. of don't the Roger? is data. the beyond that Does potential we that uproleselan But answer what we we in to be care, blinded, as the patients hopefully and encouraged So patients blinded to median standard a uproleselan, we're it from to from to well blinded longer very know think We we is of question, continue mature. see a it as our continue that it follow-up combination? data to pooled and fact

Roger Song

have question. trial. about R/R time on you commercial? will key top and have for you AML been since Phase you the data some have before the backlog team you the II, registration year Understanding potential a are upro have III for follow you are And -- Phase just up the what the line a and focusing Maybe the preparing data, been activity

Harout Semerjian

when full things which potentially an the that very for us considerations important for I interim is which us would mean, the look behind events have one ethical and at do -- the happen. of updated to now we was analysis,

We continue the also leverage this to to engage community. medical with time

complementary unique action, know, that an complement tackling other of as of uproleselan it's terms has a diseases can in as extrinsic potentially in As heterogeneous you pathway it's chemo AML. very mechanism that resistance novel, pathways are

So a in really continue mechanism we to medical of and engage the the community really medical Ed's as Bruce's limelight that the with really E-selectin antagonism through team team to both and sure expert uproleselan community. is make

some this do a cost So that's effective things a in ability continue very that us one bit actually of allows to the manner. to of and we do that more smart, timing

Operator

you. the closing Mr. Semerjian in the queue. call questions more for back remarks. turn There no to are I'd Thank like to

Harout Semerjian

you, day. forward up-to-date We look thank Have Thank operator. on And joining everyone for call today. to our keeping for GlycoMimetics. you you great a

Operator

concludes This today's call.

great You a may have day. now disconnect. Everyone,

GlycoMimetics (GLYC) 29 Mar 232022 Q4 Earnings call transcript