Earnings call transcript Q1 2023

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Operator

Good morning, and thank you for joining the GlycoMimetics Q1 2023 Earnings Call. At this time, all participants are in listen-only mode.

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

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

Christian Dinneen-Long

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

the Harout Rock, on Chief Chief Officer; me Financial call Chief Hahn, Officer. Joining today from are Brian Edwin Medical Semerjian, GlycoMimetics Officer; Dr. and Executive

based our forward-looking call include Today's current on will statements expectations.

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

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

turn now Harout. the I'll call over to

Harout Semerjian

you, Thank morning, good everyone. Christian, and

with incorporated from the leading of than first XX we pivotal advancing to ongoing of of this trial At currently this to based uproleselan be to results. reach in of longer uproleselan our Accordingly, obligation that survival originally monitoring to is months. than interim setting within out preserved progress event power the carried final potential in conservative analysis analysis development, conducted than XXXX, planned to to original live of uproleselan III an analysis. to Patients study analysis greater utility in a continues company. presents expected accumulation events statistical median ongoing expected, prior in and make XXXX. that survival primary observed independent trigger the of to of Phase follow-up its which analysis threshold. AML, half analysis planned An survival continue projected is threshold refractory conservative the This stage This plan. continued final stage a transition excellent slower continue our progress XX% We commercial committee and we on have for data an benefits clinical the events relapsed the a patients the and to an ethical highly data interim recommended evaluate unblinded February heart

therapy for survival to the are as keenly first-in-class We of potential benefit treatment to options. in our of refractory patients uproleselan focused team's fully interim noted trial we're Importantly, the complete projected event Thanks uproleselan’s performance analysis, about optimistic to trigger occur database in excited rapidly analysis and preparing trial utility potential patients and in of as evaluate to excellent on clinical to obligation this no ethical to the the effective enabling of We're safety XXXX. concerns. delivering and the overall first improve the half soon of positioned need well potential more ongoing after DMC our relapsed survival new, important within aware AML, remain possible. final

ensure accumulation this reaches that will option important to primary treatment it. who need monitor closely We to potentially continue event patients

II/III survival adults in diagnosed analysis clinical who chemotherapy. with fit pre-planned we're ongoing work Cancer across uproleselan explore its interim a evaluating As part proud Oncology. uproleselan AML in of our Clinical Trials the National spectrum, the strategy the Institute, older potential are The and alongside AML in in for alliance will trial, to event-free Phase conduct of newly Alliance benefits to patients for

quarter We continue provide trial fund strategy including operations on we're positioned and team into of uproleselan development when With cash fourth experienced interim advancing relapsed analysis XXXX, our III Pivotal expect program, late our our runway execute Phase in refractory our to and on the to AML. of updates outcome available. well to

On joined trials. our our details CMO, Rock. I'm to call, and over I'll Dr. Brian CFO, today's Hahn, happy Ed give be more to Ed, you it pass on by to ongoing

Edwin Rock

all call thanks joining today. Harout, the to Thanks, you for our on and line of

in in As trial Harout AML with will now duration time mentioned, study III means follow-up of for follow-up more refractory XX at and at months. longest any is of relapsed three and follow-up AML uproleselan Phase trial years. median of refractory this potentially median analysis, median our relapsed of That the than have primary

live than continues in longer benchmarks based studies. AML trials population other expected seen historical on to Our

Importantly, primary recent the of the and interim utility showed concerns, safety to endpoint. independent analysis survival support data no committee's power statistical preserved final analysis monitoring

patients We the continue We are as AML. possible. important by uproleselan’s ensure refractory remain potential unremarkable for paradigm profile, to as monitor safety treatment it option closely treatment reaches who suffering potentially and need about its and change event to relapsed notably primary accumulation patients that to soon optimistic encouraged this from

large randomized frontline fit study with been In trial, has II/III expected primary there's This trial, this that NCI accumulation, the either affected or through without latter aged chemotherapy, by the large Phase second of uproleselan with first a AML XXX III in our randomized also the of Alliance - diagnosed and AML toX+X a pending to which may event slower AXXXXXX, enrolled from XXXX AML readout, setting. addition Phase uproleselan. XX December older XXXX. The trial trial quarter have than newly patients years

months enrollment We XX at completion. are after now

the for Group. EFS and uproleselan were control group, for this months medians the For expected XX seven reference, months trial the for

over yet are prognosis and likely AML toxicities incidents and are increases with as time they XX, patients AML these more to of poor experience diagnosis, mortality. age, at older than remains for half patients, early treatment-related of

the transferred trial median Alliance similarly both data III in has to X.XX remain excited about if Cancer is II alliance III to In it will perform inform trial has patient for of need uproleselan generate EFS X.XXX, Alliance next Alliance events above II statisticians trigger EFS the an is and seven trial and that ongoing confirmed reads NCI intensive analysis NCI would being Phase stop that confidential this follow-up X.XX. our Phase be significant This foundational division a reached. chemotherapy regulatory the NCI, reduced address this adjunct EFS been own the long hazard proceed patients. from as informed EFS GlycoMimetics X.XXX, NCI the the has week would the under a If trial. is reached, months out unmet then GlycoMimetics these data as the to safety study. group. that XX futility. in and therapies trial ratio remain Phase with this position monitoring purposes. potential or trial the will hazard X.XX We ratio of If regimens. appears hazard last of it the Alliance novel successful, run board. XXX between hazard intensity ratio a ratio will II better, Diagnosis, enrollment to When on of New to Phase the pre-specified not by for trigger Phase treatment apparent trial a improvement of Conversely, NCI AXXXXXX the yet and of sponsor, trial, an needed At total tracks duration the for to to portion for steps been trial,

to durable people responses through and Our deeper, stem generate that curative deliver biologic more more hypothesis is disease that cell transplantation. uproleselan will potentially

financial of Now, it a turn I'll over Brian review results. for to

Brian Hahn

you, Ed. Thank

As of XXXX, GlycoMimetics had of March as million of million to cash and $XX compared cash $XX.X XXXX. as XX, December XX, equivalents

fourth of resources of ATM company advance stage common facility. are use regulatory to the commercialization continue into stock to uproleselan, first for clinical uproleselan’s from million commercial marketing evolution filings of our quarter of for of the We potential additional a XXXX. cash capital plan expected to sales runway the to During company. of These development under existing and shares and prepare $XX.X into the intend late GlycoMimetics extend approval to proceeds quarter, raised our its the

The for trial as refractory compared for patent relapsed commercial for to to which XXXX, AML, November XXXX, and million and The trial XX, as for decreased Phase to company's in III The due XXXX. were ended $X.X expenses primarily to in XXXX, the uproleselan for quarter company's our general with costs completed related to research XXXX. clinical million primarily of increased and $X.X period enrollment period administrative compared fees. planning million development clinical individuals lower same and $X.X XX, due were March readiness expenses additional development $X.X the global in the expenses uproleselan ended same March the quarter to in million expenses

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

Harout Semerjian

We're in the sharing to committed to evolution the of readout potential the analysis. II/III longest future within point delivering to work and Alliance possible. Phase partnership to trial lives to continue patients We're you, where primary patients this our unique advancing with trials We in relies strong our continued and to trial's look their and uproleselan. company's complete AML with AML elderly track have transformation capable the Brian. our patients. updates investigators need. of follow-up well large, stage study a projected AML, forward improve we who any you transformation excited Thank half grateful a of patients trials relapsed randomized we're on our we're We're our to of trial III and of on time the first look to make about with as refractory NCI in Phase of knowledge, I the forward impactful To trial our uproleselan the at in and these understand frontline to of drug's at final is pivotal to XXXX. the calls. medicines company our in these funded Also, commercial execution,

lines to open Operator. I'd now for Q&A. the like

Operator

Song first Jefferies. Instructions] Roger of The [Operator comes from question

Your line open. is now

Roger Song

Great. thanks for and taking the questions. our update

current to give are you and So, you drivers analysis since curious, Thank the for February, still of the have interim, projection and XXXX, first happen a R&R in what the the interim the the the you confidence give a new data since endpoint you. key you have take will AML you look what is you projection? the this first have the look for Phase confidence been first data half make broadly, primary one maybe if just took confirming what maybe more III in at half

Harout Semerjian

question. It’s thank Yes, the Roger, for Harout you, here.

I I So, as survival multiple projections, way the been is we've we've these overall endpoint. handling mean, our primary communicated yes, mean, before, times

Roger. that, to that communicating enrollment, since and been We trigger, November continue final our we model we've continue when to and very analytical do trigger, finalized our project events continues XXXX, build our robust a that to we events

months So, disclosed projections is really timeline patients are. will we of of do we depends where that's as it happen that of basis. as on keep think HX we go appropriate we well, that we'll projections, happen. ongoing as projections dictate projection, the updated, All pass time the will now, we now, we XXXX in like but future but HX is events and And that forward, at subgroups haven't stands Obviously, you believe will every as we number all land. what as these it as another XXXX where look that

Roger Song

Great.

of on question Okay. funds runway, XXXX, current your development and pipeline of updates runway uproleselan. much the outside end current if anything curious Maybe just the the cash the how pipeline cash knowing is Thank baking you. another is the the - through

Harout Semerjian

a take the more fuel really a up about say, cash I’ll It's first maybe the how year. to at in extended okay can that important have this we it give addition to platform. and bit part we've Yes, then the Brian kind look we've of color the earlier to done runway, and

of platform a asset we medicines this really is believe have And platform. that cusp now uproleselan are is glyco at really company, our based We on have. we to the advanced biology, most starting

has IND. know, you XXXX have cleared ready for that clinics asset is As an that we

on putting been in clinic, honest, and done I. that our be already But efforts Phase have to uproleselan. we been really We a all XXXX have we've has

to we that sure through are We XXth We use then really uproleselan of the at cash therapies. want and into some runway make other funding that hour. pull our

anything tuned stay but have on that, starting back don't the this the we clinical new it point, in of always our cash time, side example, with this that at the XXXX there, do really Maybe, an giving the we're the Brian, runway get we better uproleselan. extension. any programs but faster if to Roger. of at always as mind new color can on That's is, on some So, our it's

Brian Hahn

previously, disclosed a and from were $XX clinical the had million It's the running to from quarter. quarter a reduced the trial we as down yes, FERN. That's a about of in cost mostly Roger, we manufacturing $XX about million lot reduced expenses. expenses

saying, of uproleselan, So, other areas. a as to focus the was lot research small some Harout around now amounts is with

Roger Song

Thank from us. Excellent. you. it That's

Operator

Boris One our comes next from And TD Peaker moment for next of question Cowen. question. our

Your line is open.

Unidentified Analyst

my for taking on is Boris. Thanks question. Great. Nick for This

Just ones me. for two quick

the rapidly First, you mentioned the complete final OS that after trigger. analysis you'll pretty event

that that was question additional were there wondering know So, through as that any running in data should and I the take bit XXXX well, the to And everything. we half if IST data or I have consolidate actually early. some testing longer expect then that little there grow? are was is, it'll second like two trials first I had a parse of positive

idea these new any trials or So, have else in I if IST Thank you potential you. anything on that for was data wondering matter?

Harout Semerjian

Maybe the Ed, you tackle give question, first update thanks then an on Sure, I’ll Nick. ISTs. can

can our from I want first mind. sorry, - to understood I you sure just don’t part just question? So, your Nick, repeat if correctly, make you

Unidentified Analyst

definitely. Yes. Yes,

event, you as have XXXX, guys event the expected final the trigger So, in XH is OS mentioned.

the expect wondering bit. that'll take it'll too, through the I a if data or little data we release a little data to longer then was if back So, and bit push and should everything, then parse

Harout Semerjian

it. Got

Okay.

So, maybe it. the a things, we I'll give couple of are way about thinking you

that wanted interim very into that are as make to we ready and sure the do the in into and Nick, move expedite So, passed we case get to very, and analysis, we ready we really went to threshold, final database lock had we analysis interim high that analysis quickly.

step that the to January, been even already the the holiday as over well, has really ready. So, thanks done efforts December, of get break to team us

look from do the That it, time have have until we So, the at the DMC really again. time will the really full when that shortens a don't we to take analysis.

an when HX analysis, will we Now, that have within it all on depends Nick.

sometime later So, the an data. might what's weeks then of If going in so having QX, that's a going happen. end after, it's get we HX. it if I'm to say we're can of HX, there QX, saying the be example, as just happen of spillover middle in to outside not within let's that It’s then

a the is, on So, just have data are you some the we to about good lot you patients think really now and for long-term goalpost cleanup, news is as - accelerated know, follow-up. of the

data have the make So, job clinical that that much and our of to good faster the go we back teams some of will base. get queries hopefully the and now the

have? So, how that's And want think maybe would that perspective. to Ed, we the kind any a on ISTs, data disclosure of from updates it you about

Edwin Rock

Nick, asking. thank for you

responses. encouraging We data. That evaluable eight negative MRD continues those of unfit of treatment enroll. or There As had chemotherapy patients, and that reported ISTs, of thought investigators to you know, by AML were on the Jonas. trial had we the six at reported Brian in one four ASH, complete ASH, two of frontline six for responses, at intensive and University whom was Davis at California

this are of we’re trial you, not We it time, numbers disclosing and progress the keenly forward. moves as at interested like in

negative The other responses low-dose time. cladribine. not continues, at there, enrollment They trial. and this treated in similar by led receiving we responses, that's Similar trial are as combination Anderson, similar we Dr. disclosing MRD those uproleselan patients in and and Jonas with numbers secondary understand MD was numbers, AML. the Kadia at Cytarabine Similarly, are and with

Unidentified Analyst

very thank really That's you Great, much. helpful.

Operator

Ed our our next next One question. comes H.C. Thank from White from moment question Wainwright. for And you.

open. is Your line

Steve Bersey

our Hi, questions. for this Thanks taking for Steve on is Ed.

could GMI and do this getting year? find interest, for partner program think a you you the any partnering are for you XXXX, So,

Harout Semerjian

XXXX Yes, thanks, solid remains for program us after very uproleselan. second Steve. a

as this As is you cell its unique action know, well. mechanism other a potentially given indications, sickle market and of

So, to any disclosing Steve, point, continues That not at ongoing. specific discussion, this we're be partnership.

also the perspective, the well capabilities For funding refueling runway is been a table, us, us in to as really And crash fact not gets but successful on that from focused well what's important only bring partners uproleselan. who we've and competencies. as

disclosing point, this discussions. At not that. to we're specific tuned any partnership stay So,

Steve Bersey

Okay, And if may. great. one Thanks. more I

about So, for prepare how we going and expense as long forward launch? should R&D think SG&A uproleselan you the

Harout Semerjian

to that? you Maybe Sure. want Brian, tackle

Brian Hahn

Yes.

For trial And $XX anticipate burn the quarter. and still on our the would this be the we giving results, I about we'll million guidance XXXX, think guidance then year per get we into after expenses will be launch. what for

Steve Bersey

Okay. Thank much. very you

Operator

Thank you.

to in questions the are Semerjian. turn to there Mr. microphone I'd queue, no As back more like

Harout Semerjian

Thank operator, today. Jefferies and at going to It's to you ASCO much. updated you the of very EHA. be Health some and forward you so on joining time. our you, We everyone thank busy at and keeping for you and for GlycoMimetics, look good Thank a Conference, seeing call

Operator

you Thank you. now Thank conference concludes disconnect. call. participating, and This you for today's may

GlycoMimetics (GLYC) 3 May 232023 Q1 Earnings call transcript