GlycoMimetics (GLYC) 27 Mar 242023 Q4 Earnings call transcript

Good morning, and thank you for joining the GlycoMimetics Q4 and Full Year 2023 Earnings Call. [Operator Instructions] Following management's remarks, we will hold a question-and-answer session. [Operator Instructions]

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

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

Medical Officer; Officer; GlycoMimetics Brian today Bruce On from are Edwin Harout Rock, Chief Dr. the Commercial Chief Chief Hahn, Chief Executive and Financial Johnson, Officer. Officer; call Semerjian,

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

Forward-looking data and cash statements us of by statements and from activities; company's or planned position readout plans clinical product agency may GMI-XXXX; include, the runway. uproleselan the regarding conducted being or but those or prelaunch are trials; our not limited candidates, submissions; regulatory timing and and development trials potential about collaborators, to, the including preparations interactions and progress expectations company's our

involve of management's represent or forward-looking statements Such obligation statement. to undertakes revise and judgment and update any intention as uncertainties. GlycoMimetics no today assumptions, and risks

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

to over call the turn now Harout. I'll

that impact I the company's In line GlycoMimetics. with helping XXXX you, myeloid uproleselan. commercial for live path is trial XXXX, our of relapsed great towards potentially leukemia we will Thank candidate, company. advances of refractory year XXXX, becoming be quarter transformational In report Building morning, fundamentally and patients believe This Christian, to III strides this our acute good top in milestone everyone. significant made and a lead expect from made results longer. a while we on the second on affected Phase year, our the we to trajectory a drug can

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position Thank factors perspective, of a uproleselan if for you, approved. success, number are commercial could From Ed. key a there that

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

Bruce. you, Thank

as as ability GlycoMimetics compared additional in the cash equivalents December increase million to December $XX.X early of XX, raise to of had XXXX. the due XX, As million company's and XXXX, to This cash $XX.X cash was year. of

to the completion in GMI-XXXX. decreases were development decreased trial development fourth The the million $X.X III due company's for clinical $X.X research ended batches decreased and the the ended These to December the year. quarter to relapsed/refractory Phase and development Phase of prior for and due quarter for completion expenses ongoing XXXX XXXX to manufacturing expenses million XX, our decreased as the $XX.X to compared compared million of year December Research for engineering XX, XXXX. of uproleselan, for clinical trial of with with to clinical I to as million and expenses offset the cost AML lower partially validation uproleselan global related individuals in $XX.X

million and to as General company's to administrative expenses in and million the million ended These as The quarter XXXX XX, expenses $X.X XXXX. consulting in to $XX.X for the year fourth $XX.X personnel-related XXXX to due million expenses, by for administrative to December the ended XX, higher offset quarter $X.X increased decreased a increases year. general prior decrease compared of December expenses. for the compared were external

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

Thank time In long our closing, company. now road exciting has have you, a for Brian. and it we reached been a very

uproleselan our III the on study and line We in top are focused Phase refractory of relapsed results AML. upcoming from

our pending We continue transition into on and work positive commercial to readiness to results. are a prepared commercial stage company

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

Our Instructions] Tara first [Operator TD from with Cowen. Bancroft question comes

results the So my filing. be with potentially plan believe for the first data could time and question is be the to available frontline Or what's whether you relapsed/refractory a included in that? together

And added running those is you Like the Does it that be with then III over how those and be think fruit? will successful, time? that include you're you Phase or next, expand upro low-hanging how the initially if will are time? could can used which patients over describe mutations

ahead, And Go then to Bruce. to over take address Thank question turn the first Bruce? potential about the second the you, Maybe question. sequence. I'll Tara. Bruce I'll it

you Sure. for question. thank And the

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with the And your Bruce. you, trial. question, Thank NCI-led regulatory regarding Tara, frontline first for pathway the

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of that we data that So kind happens. to have wait until for

in is And know, II/III trial registrational-grade adaptive as trial. the a of frontline you setting Phase course, the

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Capital Securities. from question One Naureen next Our comes Quibria with

have of slightly Congrats you will which to up And on the and the progress. time-based. now the the it then it end top sense event the of number the you I'm how And line is, just Or this cutoff, what it with curious a study of what would will I from is in clean you I'm Do data data? line? the guess quickly top terms report XQ? month, will release could asking is? you report towards be be earlier? be that able

X led imagine. reduction we've Yes, follow-up mature said of is number you, you of can a seen that who've transplantation the and the more a question. last patients significant as quite this events to slowdown with of have as of us 'XX Thank a in is follow-up a years vast both had But mean, get we're X time-based from a fact Yes. we which I is more of terms a summer the the a majority with to the that given the on paths that back in database for on perspective, a we've throughout Naureen, well. median than additional than end and multiple years of asked over 'XX further of seeing Yes, of the are over a we've Where that couple bit, given agency them we aligned as forward. events. clinical what stages, align FDA now analysis, times go now

the So of reporting it got also days. with And goes method mentioned, the teams to know, clinically the allow The quite with we've positive that data takes log, this release we're end analysis so makes really in then that few that in and it database then triggering press mature. confident database the you basically we database to the of XX, QX. timing a And a the as hopefully cut-off, March it. cleanup, do

events our So back of the see number we for the in obviously trial.

very we events, the blinded do in we're this methodology. We are but and see confident of time-based number analysis

tuned. stay So a good the will release. In QX, have we hopefully That's press aspiration.

RC? details? this Got usage collaboration it So ASH will you it. size can And about have you the you the more any other or do little have when idea with a expected of just any about initiate bit study, that share

yes. definitely. Sure, No,

to it collaboration. Ed, this about very I turn I'm Before excited

As still on you can approach. we're expand for need dire And treatment, collaboration. with in maybe, our patients you are especially our know, with sickle cell excited further Ed, why

getting with Research partners indication their the field. multiple Research will Yes. leaders as going we vaso-occlusive that that on their method sponsors point we ASH in as expertise our in drugs that develop, into to feedback events, keeping well cell And Collaborative study as The the disease. so of is tapping alleviate cell is from mind to ASH give to disease sickle the first patient their care of their both in forum a and which sickle this we appreciate are we're unprecedented. development from patient's clinical investigators perspective expert within ensure plan internally feedback Collaborative on The

can had from this lead for time. where right a And the takes clinical I having we there medical with of collaboration, design as as our need asset. to learned the hours, original true to difficult, that know the fact outcomes beginning it with from exciting And is good area very within know, enrollment if you a benefit way the patients in our previous mean, to honest. if reported generation unmet a generation it you this is be perspective. last and -- This exposed BLOOD Yes. disease post a year. was do statistically XX we us, don't we significant that We've previous unfortunate is the be to enrollment in our stayed trial first hard hoc

want So on level, much are cell in be we're investigators' this the on that patient hand involved who it time, the in hand with make very we it be community, go to the clinical sickle like, we we're sure we looks working look people in so level deliver would working paper, done. actually tandem only able that not trial so would a good centers together on what to endpoints are really to that it co-create we get can which really but

So I'm in excited collaboration. about to will this hopefully, progress report months very And we come. on

That's helpful.

Okay.

I just question, Sorry, final Phase for back guess and the me. to one flipping study, just more III one

Just submit or any to [ year-end, that? complete have assuming to the do studies you need before clinical NDA before you plan ] you positive, everything clinpharm still that -- everything

know, trial do. taking you to as been has longer I Yes. than mean, this it supposed was much

needed cleaning been the So of you the also Do we've really on want data the lot clinpharm. to the side, particularly? clinpharm a -- but tackle on what's

Yes.

FDA, that product Regarding the response information trial clinical FDA as effective our the ensure to analysis and well will use label included Phase PK III we in with This the have and drug. toxicity safe and exposure appropriate and exposure direct analysis for in our of analysis expectations program. agreement pharmacology, accommodate are population as

Wainwright. from comes Our question H.C. White Ed with [Operator Instructions] next

save collaboration, money a start you your financial And just Will you I for if you're collaboration with any looking you there it development? somehow? development. further going partner alone? are could just this? this go for mean then can Does This review be to Perhaps in XXXX. strategy to Does it stipulations

we mean, to Good any to effort. that make Ed. of effective, sure you, for and we're to time hear voice. Thank your got I be Yes, people's collaboration, compensating it Yes. course,

there their So for a but is efforts. component modest It's there. financial it's

not. more. to advance second know question, your that doing we're want or sure open it are would really want regardless learning that's regarding part I we conversation. is And of to we not, to going we're we the if it do mean, XXXX What alone we or an and make alone

relevant be program, setting we in we're that with advance that very want in in Before endpoints the to into we're a patient a sure by move forward much clinical developing and we also very physicians but trial can make clinical for the it full-on it's patient. delivered voice, development tune tune with

of be of anyway. the a execution we're lot going those And how So to insights, forward gathering insights. of it's regardless helpful we

a patient this So a no-regret for us, on aligned credible with outcome. very really is move group us with cell is that sickle the

So collaboration with pleased be we're them. will development clinical in used course those with very a highlights in And due then setting. that's why our

really other is the and in in uproleselan it's on strategy closer is my -- then question all us much something launch for start past. But thoughts that discussed give a thinking just, which to about relevant And since think thoughts that that. it's can Okay. haven't your on you Europe, you your U.S., to on your you're start get getting potential the I

No, plans Yes. Those They're are underway. Ed. absolutely, ongoing.

plans to FDA with work also Our but not European from the just are perspective. a

on haven't We is the the but European ongoing. guided work side,

Phase our U.S. Europe. trial, clinical many our in know, sites you half and including globally, III is As half

So there. we over patients have

We be know due European to course, time. are uproleselan to agencies how going working have well the exposed in experts And as it. medical with who use to of we're and

be our as well. turning on is but to we should focus then Europe first attention FDA, the So

underway. also that's So

And turn any Harout I'm remarks. closing over call to like no the I'd showing this further back to questions at for time.

top you, and updated results sharing look you for joining everyone GlycoMimetics We you. in call our QX. to line Thank on operator, you and keeping today. Thank thank to forward

today's call. concludes This

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