GLYC - Earnings call transcript Q1 2024

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Operator

Good morning, and thank you for joining the GlycoMimetics Investor and Analyst [indiscernible]

Please note this event is being recorded. Today's remarks will be followed by a question-and-answer session with the management team. [Operator Instructions] I would now like to turn the conference over to Christian Dinneen-Long, Company Counsel at GlycoMimetics. Please go ahead.

Christian Dinneen-Long

morning. Good review lead from drug will study Phase line our of candidate, top we our results III Today, uproleselan.

at A morning press website and this glycomimetics.com. is available release on the was issued company's

company's XX a is call replay available section close replay The being Investors the and will available the hours This days dial-in also in the after the website. be recorded, will phone be call. webcast of for for of XX

Dr. Edwin Semerjian, Officer, On and the for Chief GlycoMimetics Hahn, Brian Harout today will session. available Financial Chief call Executive Rock, the from are be the Chief Officer. question-and-answer Medical Officer; company's also

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

company's may and and risks our collaborators, company's plans. presentation; Phase trials and the intention statements statements regarding company-sponsored by Forward-looking uproleselan, activities; timing or potential judgment not assumptions, being clinical management's today data conducted data as data but about the burn product uncertainties. trials; the trial; planned and of of readout from limited and development plans from statements III the clinical progress represent cash involve to, regulatory and include, and including and are those candidate, analysis expectations and Such budget of

or update to obligation any no undertakes forward-looking statement. revise GlycoMimetics

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

now to turn I'll the over call Harout.

Harout Semerjian

statistical intent-to-treat relapsed/refractory in in in we with acute Earlier of improvement the top study our everyone. survival you, results for today, uproleselan Phase population. announced overall the achieve did of not Unfortunately, FAI leukemia. the MEC Christian. combination morning, Good a study placebo Thank III significant pivotal myeloid line or treatment or from

profiles consistent were side known used chemotherapies events Adverse in the study. of the effect respective with

unprecedented learnings were will the this we study. X of patients from collected XXX for not and from is there be this While important data follow-up with an over hoping outcome years,

data full and evaluating we rapidly share experts and and to diligently set the plan regulatory appropriate. statistical with are We as medical, updates further

comprehensive and at a FDA present data a to unmet meeting with data intend plan upcoming medical significant an the developing need. analysis patient given We to discuss the these are

to want families to investigators, sincerest this their and large, dedication most the patients sites, trial offer to the gratitude moment my importantly, take for trial. well-controlled I a and to randomized

to uproleselan I for and develop GlycoMimetics their also working to want thank for our tirelessly investors the support. team

remain exploring in uproleselan's We dedicated to potential AML.

are results sponsoring trial As become is newly trial an diagnosed a uproleselan We fit forward for to look sharing National who II/III chemotherapy. evaluating reminder, the Cancer older in when Institute Phase intensive with available. they AML ongoing this patients from

turn I will the over call to Ed. now

Edwin Rock

Harout. Thanks,

with AML reminder, placebo enrolled chemotherapy. to XXX randomized countries uproleselan study patients XX or a groups sites either and or receiving investigators' X relapsed treatment across this choice of total with them As of a and refractory MEC in both FAI

randomized rate were November patients low study and XXXX, the a by of All X%. had discontinuation

XX III data an uproleselan. June the time-based addition analysis March with triggered And In FDA of was optional a study cutoff. analysis primary XXXX, of Phase to this time-based the randomized cleared

randomized respective were refractory compared achieving profiles As a had of arm uproleselan study control with in overall chemotherapies. events in Harout endpoint AML. primary relapsed III survival trial of mentioned, of median overall X not our survival unprecedented the treated uproleselan population. of in arm. statistical Phase adverse of over XX its year Patients with meet placebo XX.X known Also, median intent-to-treat did in months months the is and therapy survival the group a side The significance for consistent in effect the to

forward benefit data and results important potentially results to We the statistical and any that of this understand we make when comprehensive available. thoroughly look will medical, these lessons analysis features these experts could our sharing analyze with and to AML These scientifically population. trial regulatory

now turn to back Harout. it I'll

Harout Semerjian

and rigorous to analysis. We through reduce committed burn forward deepening as the we our the we cash of the set. ways remain Ed. complete understanding study our to Thanks, to look full also evaluating data sharing We're analysis, rapidly full

In the back budget. we regarding coming report weeks, to expect investors to revised a

Additionally, for share uproleselan our we possible. as reasonably updated soon will plans as

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

Operator

[Operator Instructions] H.C. Ed Your Wainwright. White first question with comes from

Edward White

as the your thoughts the unprecedented? survival in was out median expected? wanted any just you I on initially you than longer So so took to control to seen thoughts the study get on group read why why, And much said,

Harout Semerjian

XX the highest control months arms survival in in overall And had control longer also months Yes. survival uproleselan given the trial median but of Thanks, because what aware relapsed/refractory median predetermined of is the a overall arm, of the that the number endpoint overall anticipated. XX.X of continued than trial live we a probably setting. we to I arm, Ed. survival one in everyone, are of this hit. that to for patients mean, a primary reminder The taking with as a longer was

So We soon once this full-on that's the additional across running data-rich to market we insights. have those, share we we we can. Obviously, them what medical conference and what's also that? analysis this are to where subsequent trial is driving now a at as And a we plan as know. understand to -- really

Edward White

study? the to to the there be before going And ongoing. the impact other look an just an there question anticipated take studies NCI data readout? on on that interim ability Is Is Okay. a any are there

impact is there China? study any Apollomics And then also in to

Harout Semerjian

their to Apollomics, second a the off comment partners. probably ask our there on Probably be in Yes. question China. it's wouldn't in Apollomics, to better about trials to situation We

conversation. March, that have trial, them. still light going NCI NCI the are And with we trigger they of our going not over additional as reached ongoing have EFS of we here, course, team in our have dialogue of conversations that our at part we're disclosed time. interactions with last have And to as in the regarding data the But to

-- therapy. And endpoint. a backbone different different It's important a it's of different it's it's -- remember, therapy. it's different to a thing line an We a

So there combinations as but are are those is, both yes, and important said, lines, for different keep different area in things of is the endpoints primary under the different are AML, to mind broader II. Phase them I

once So we'll know how or a tremendous does share from as we've once today. we we there's see see more but that data think impact and we seen But read-through data well. will available what that don't that becomes see here, we they actually whenever that over

Edward White

XXXX, Harout, going your forward? Okay. can on if address just on and that is strategy question thoughts last you study my just

Harout Semerjian

that is learnings Yes. XXXX is a previous asset an we developed internally based the very I mean, generation. very that key have asset. from good on

advanced it advanced Ia. the to. drug Phase we do know, have it as through you candidate behaves We As We've wanted IND. Ed, we through that see

at it's to our situation regulatory going at conserve and be on looking be at it a there, partners with focus full-fledged probably and our cash with and too statistical Given and this clinical a understanding to that going really work we're over as going closely partners what's will really of early looking with to ways deepening XXX on partners, really say with we're budget, happens point. to priority but financial revising what be else

Operator

the of Cowen. line Tara TD Your next Bancroft from question comes with

Tara Bancroft

me. Just one for

types had could Like outcomes, is you sure know be you full if of postulate more any know which patients for won't this I think it we to if discuss effective? the some wondering analysis, that I'm sub-populations possible? potential most until do you So where could but

Harout Semerjian

and Thank have we Yes, it. you, mean, I point, is we got from only days Tara, data literally turn few to this a an around X for the the X, when look, communicate your We're question. right, days. to it obligation in, and

is communicating have XXX and multiple going the to the top different really we're the we're really of follow-ups, we longest And at paying looks patients at to same time, what So -- line. tribute are with it. one

it subgroups. the actually to study is comes when powered not Obviously, subgroups, for

However, status, the as multiple include disease does therapy. such factors age, stratification design backbone

review help, signals group, for it's data important us can the full we are there this first there are in additional new really the can conduct in relapsed And are really therapies. Tara. because it's to know, patients under and you comprehensive we that folks of refractory patient that AML all so understand as what set So need those ultimately of

and on well. we as be possible. on, And duty So into soon it's as it what's that our understand real to conducting to sub-group as going level really going are a look really

Tara Bancroft

And Great. just follow-up Okay. one quick on that.

think So you based your do potential the be on would supportive filing the population? of a agency limited FDA, with engagements a more in

Harout Semerjian

have to I can that as want speculate early. this we've we talk wouldn't to are do refractory had is I for patients, new with because end the good FDA with There that is we orphan trial. AML. put multiple, the this say of fast Yes. were agency designation, conversations point, We patients, what refractory the they've very aligned AML the developing in, at behalf us options. just a of relapsed day, this things track, and relapsed it's therapy at which asked and those status the But did. we're reason or FDA need too breakthrough And on

speculate that a but make of it statistical really would conversations, the perspective, those to if clinical news. are they at our from understanding, perspective, point. do this deepening with sure the look advancing too So will both our be a path out and data. there FDA having and and part early at we based And partners is be regulatory such would we good further reaching a from to perspective that also a see then understanding what engaging But on as the forward, from obviously

Operator

line Capital Your next question comes from Naureen with One Quibria of the Securities.

Naureen Quibria

Do comment if to it many MRD-positive that I [indiscernible]? hear went to patients. on the MRD-negative I And on you just are transplant? or around one to guess, transplant know news. on patients you how just became able in patients have Sorry MRD-positive/-negative proceeded really MRD-negative was to

Harout Semerjian

Naureen, have patient, disease, transplant -- therapies, this rates, your with backbone the I different of Yes. therapies, stages MRD-negativity, point, for you, question. rich we mean, such different Naureen. to database subsequent Thank data

team these such the So regulatory going being insights and by are FDA. we at the these we're to the speak. compiling having it, be learn about And more conversations all we as more as and looked agencies, as with

tuned. stay So

committed given are database to this the rich We high the and need. understanding, medical given unmet deepening

Operator

to remarks. [indiscernible] closing back Harout for over

Harout Semerjian

you, today. Thank operator, thank call joining operator. everyone and you Thank our for for you,

stay tuned. So

to as We Thank soon very as market updating the can. much your for are attention. you we committed

Operator

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

GlycoMimetics (GLYC) 6 May 242024 Q1 Earnings call transcript