- Earnings call transcript Q3 2022

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Operator

Good morning and thank you for joining the GlycoMimetics Q3 2022 Earnings Call. At this time all participants are in listen-only mode.

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. Please go ahead.

Christian Dinneen-Long

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

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

will will position, comments uproleselan We on of from provide who will by company's based forward-looking for then on start the on and uproleselan you to call the followed commentary include business additional clinical overview broad expectations. Brian before studies, open Harout, Ed today's I call with today's program, on development including financial with provide would both Q&A. like the statements updates current that and a remind details sponsored investigator will we call trials. company

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

refer the that SEC, with turn on factors website. SEC which call I'll Harout. concerning please are the For could filings affect from to risk the over the the our now or available our information to company,

Harout Semerjian

X myeloid a stage and with good chemotherapy strengthened morning we refractory, quarter, acute our foundation in of our progress substantial company. with with and we leukemia our pivotal relapsed, Thank with commercial in become past This patients to made in trial line everyone. Phase uproleselan Christian you combination further goal

share We study the Interim essential Interim addition than excited the that pooled We our U.S. should X patient Utility is Phase believe Administration blinded to an study are today Analysis Utility longer particularly this given that with living Food Analysis uproleselan recently protocol. Drug and to cleared in of expected. you population the our be

order plan. our and medical engaged As we we with conducted the analysis data discussions with in part decision, careful we of experts, followup from our previous to multiple validate FDA in met of the AML,

Phase reminder, a week, year second announced enrollment ethical for blinded final pivotal prompts mid-year transplantation our may distribution events quarter Simultaneously, completed our AML, population. patient in relapse to slowdown broadly uproleselan which study survival relate extend the projection we around survival is event age, refractory us X The completed is and we to overall to an X/X appropriate that analysis pooled patients, from call, similar together taken with possibility of we one to the therapy. XXXX. of severity year accumulation slower recruited and study population As need stem Phase events the trigger rates we this interim our end of of address respect study that cell trial us Phase this to patient ago see benefit prior analysis and for the to from XXXX same earnings gives of X in that this as confidence

and XXX% whether events data un-blinding is the the events study's in chemotherapy standard patients remains and with survival Monitoring QX accumulation immediate We the owe pooled Independent overall analysis, DMC analysis unmet to blinded, trial assess treatment limited with need efficacy this original if they'll to to They be trigger, expected meet recommend which slower drivers in to survival interim with Data the of the Committee of treatment to options. a uproleselan or combination XXXX. is for completion. of by observed disease, consider it for AML the part to As one end compelling, will or continue high

them final Importantly, study the the cell by analysis maintain of we AML overall help registrational areas. expedite recommends stem From on or continue to original potential preserves this improve we excited Independent deeper, focus improve relapsed, study remissions survival. us the in patients designs uproleselan's enables continuation and a to whether XX% blind bridge us outcomes alpha interim are to we enables to transplantation recommendation three refractory curative DMC's and continue planned, potential as to of standpoint, and originally to DMC the durable if Regardless that filings key to achieve more analysis. commercialization

awareness to in mechanism E-selectin differentiated unique and First, of drive and and uproleselan's experts medical on educate biology AML action.

Overall, with to development Bruce global medical available will to community. expand X efforts, position Q&A execution key partnership drive which quarter officer, uproleselan's steady GlycoMimetics. for Commercial Chief Johnson, to expect Second, period ongoing Phase for to approach third, these discuss progress, of third marked well milestones. and awareness the we as our a we our be us program, of clinical and significant

treatment need uproleselan Rock, will Annual share as on I'm Dr. advance first significant Two the on our presented to sponsored uproleselan with how this Society of GlycoMimetics for our trials updates pass other investigator on spectrum sponsored it. therapy reinforces trials. outside to AML you provide unresponsive context Ed posters These to data welcomed our of to in He disease. randomized just I'll for AML confidence Officer. we effective details. Phase ago be will AML potential how in company the it few more have treated for this the support uproleselan's who on clinical to Ed notoriously more American who across Chief posters Meeting share Medical from trials. and at compares comparison the We in additional naive provide uproleselan X, upcoming to large of deliver represent it therapies. secondary address utility team joined historical unmet will also the patients belief our pleased that potential place this a short presentations the and need to broad be months by call to therapy Ed, Hematology

Edwin Rock

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

Let landscape. me begin with how fit uproleselan could the AML into treatment

languishes U.S. survival on given As introduction outcomes blood with drug five persists in years. will potentially and cell second is XX,XXX their the in vessels, about blood death drug signal now After most regulates and unmet annually. among medical XX,XXX the carbohydrate conferred binding several cause people by years E-selectin to resistance E-selectin believe interrupts a with vessels disrupt leukemia. recognition than myeloid cell Uproleselan with E-selectin diagnosed mechanism, new suffer the AML's thus XX%. resistance. mediates disease. therapy from chemotherapy frontline E-selectin XX% all pro-survival antagonist. that attachment to need Uproleselan type improve We and adults cells therapies, relapse by Five-year diagnosed reminder, resistance. newly at this for blocks AML AML of devastating binding. patients uproleselan leukemic of of targeting to thus heterogeneity contributes leukemia with and the and this novel Despite the last survival our common is investigational, People more and first-in-class living outcomes. patients patients highest are cancer dismal of About within AML high three are

would expected AML, are explained, be Phase in uproleselan Harout living refractory this study that survival than benchmarks. our pivotal relapsed in based show X events longer of trial As pooled and in blinded historical on people

are to by Data analysis meeting whether complete to to observed. once plan to expected analysis OS As Committee The study Interim earlier to the to failed in to survival The of higher an this a did whether survival followup trials events endpoints and uproleselan efficacy primary trials survival will meet of such, alternatively and slow relapsed continue duration survival Independent XX% over our two accumulation refractory late That immediate point recent the cleared or show prolongation The our meaningful. time meet is that treatment and AML represents we fall. Phase death target relapsed study's clinicians, at this approached about interim a plus in hazard AML Regulators, analysis X.XX. event end FDA is chemotherapy treatment to uproleselan risk overall assess QX, are if the that reduction data agreed XX% any and uproleselan in AML study median improved is in benefit. standard adding Recent and notably planned had of recommend ratio XXXX at five cytarabine XXX% In this X events clinically study seven original at occur observed trial is and about Monitoring patients, alone, level benchmarks survival summer relates from consider original in that months. of with survival to compelling. trigger significant to FDA analysis. contrast and their recent of refractory be time. between in have

followup the be eligible that may interim number compelling Should relapsed to as positive months, median median study order and end around that in uproleselan Phase And addition at of product XXXX, showed for demonstrates That novel XXXX. illustrate benefit therapy, survival benefit will alpha more AML endpoint. benefit. that is months X+X based analysis trigger, trigger continue pleased Dr. events showed trials on design event interim study those the now beyond substantial accumulation all to in upcoming recommends original mean the survival University trials two a through intentionally from allocated is would the confident outcomes X.XXX remain trial are and would his we If original AML investigator of final filings Meeting. That AML. to primary presented at survival translates sided for final who ensure months AML of accelerate trial at months DMC study is to months. present and the threshold ASH alone. Annual relapsed followup. the value was not study enables of if be in the of over the for to study spend Interim followup. about recognize spend projected secondary analysis, Jazz's and will expected of AML results benefit indicates expedite in continue refractory specified our more of followup soon patients of from trigger, from in than evidence events we're than conservative the instead patient positive time to to within than analysis Based at as the of conclusion refractory to the Alternatively, as refractory of extend P uproleselan Astellas' a we therapy. followup superiority in that stringency compelling profile therapy. survival analysis. chemotherapy XX% September, of study exploring on we original met another at that Brian of analysis preliminary as the to same are the untreated year XX in patients with Separately, FLTX a uproleselan uproleselan's still or around less duration with benefit in the to AML reflected interim unfit duration Whether of Venetoclax improve analysis salvage events with X in to possible relapsed potential If trial by relapsed over of tolerable of Phase Alpha sponsored California protocol, uproleselan remains X% potential relapsed, remain total will sufficient of planned of excited then described to of X.XXX. months the roughly in want for any end trigger XX that These uproleselan's benefit of chemotherapy this alpha Jonas X with us AML through recommendation uproleselan median XX declaring course date, full intensive and final high full time refractory refractory of to Median the a we ADMIRAL the is analysis. protocol CPX-XXX of XX disease XX.X registrational evidence unprecedented DMC's as the analysis original azacitidine planned gilteritnib events people Davis chemotherapy. X study results two availability events with of XXXX, Phase analysis AML. the safety we original then superiority for XX order

well MRD an encouraging rate CRis. of among as in negativity disease patients, XX% In the safety, shows addition this to with eight evidence evaluable also combination MRD encouraging responders as responses activity, of overall XX% including or complete negativity

combination Phase uproleselan cladribine of the Almanza-Huante plus than trial having first risk in expected present preliminary Dr. very was a an treated that patients This secondary low-dose of months. similarly median a overall from results showing Xb/X cytarabine XX XX% patients of rate five high well produced will Additionally, survival Emmanuel with tolerated. less of response population AML

other grateful and of and presentations unmet disease with to toxicities. running uproleselan generated their indications, with for trials uproleselan relapsed-refractory available clinician ISTs patients the need. clinical benefits outside dedication forward patients. as Also, our data to the thank profile these belief are look more potential sponsored broad about sharing the a in provide we populations well these in uproleselan. favorable of to company in to consented have demonstrate evidence high AML uproleselan exploring as We therapies data utility scientists December. dose first fit safety investigational trial, Despite We appreciate data combinability without of in studies limiting across and of these patient at numbers, that These potential testing are limited ASH support frontline the these for

XXX in addition whether Beyond leads evaluated enrollment study in this who or Institute also trial of XX the standard This to X+X Cancer to by year portion X/X Phase National Phase clinical frontline outcomes. is XXXX, is ago. improved and NCI The November, in a X years in older one randomized evaluating independent adults, patients described, trial of the older. of uproleselan AML an completed are newly being uproleselan regimen diagnosed patients studies open-label

For expand the intend outcome another benefit NCI interim we will for Phase anticipation free label us frontline This uproleselan to interim planned enrollment the further event X and Phase When our to to confirm the of gives in suspended the protocol, has of NCI of its available, NCIs analysis to AML. reopen share whether analysis and trial X. trial survival. include opportunity potentially

the X outcome additional refractory uproleselan relapsed AML. opportunity and refractory of pivotal in beyond analysis relapsed that of Phase is NCI’s in our Importantly, study Phase near-term an provides from independent X AML that for and thus

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

Brian Hahn

Thank you, Ed.

as the first cash million of had slowed of of to million $XX.X of As equivalence as to cash XX, cash million burn September to compared XX, $X.X QX GlycoMimetics XXXX, and as December $XX.X XXXX. million $XX.X quarters compared XXXX. over two

the due enrollment the in to November, company's as expenses development I'd administrative to to XXXX turn period XXXX. general for XX, quarter of trial pre-commercial and will key savings XXXX. and in global Decreased ended prioritize XXXX, call development third development including The relapsed operations our clinical We the XXXX fees. as to expenses activities, for to in current reduction ended Harout. to cash the now Phase transition X commercial of of a of clinical million Phase to and the program, follow of compared trial lower million as resources expenses were fund to a to ended and from the first end million of advancement the to quarter and for result the due XXXX $X.X company's million the quarter realization uproleselan the regulatory professional of our $XX.X third XXXX. expect primarily manufacturing primarily $X.X Allocation will resources activities. headcount to AML same $X.X as costs research XX, The decreased decrease up, X key patients of the by expenses quarter like compared of lower refractory September uproleselan in driven September to the completion decreased continue back

Harout Semerjian

Brian. you, Thank

demonstrate GlycoMimetics. a update, us today's very at time this exciting for As is

we're but encouraging look in survival possible. remain organization our as this analysis important additional to the populations. refractory also potential in planned as the longer study position just survival you of this or cancer quickly questions. are potential patients, to relapsed analysis, like Given AML, trigger, illuminate registrational to bringing toward by to that experienced for patients for interim Though to in our ISTs progress, our uproleselan uproleselan's outcomes with refractory and Regardless these expected interim from advancements Phase patient enough uproleselan relapsed the Phase conducting X the open AML proud product in of through of Bruce, analysis. as We're team, study Ed pool blinded the with than overall we a exciting committed parallel in In and well I'd preliminary improve study forward limited sharing the uproleselan to sustained patients Operator? demonstrates of approved. these and continue clinical continues working pivotal the continue this just lives to calls. the is about deliver our to excited described. compelling filings to they commercial we goal prepare to not data updates activities, finer forward if this now expedite we market successfully events inflammatory the that X led to future AML confident results and of our in diseases, clinical on continue of look These improving us with to lines whether number

Operator

Wainwright. comes line Instructions] first Ed Thank is H.C. at question from White Our Ed, you. [Operator your open.

Edward White

questions. my Good morning. Thanks for taking

if the and can you regulatory of potential IDMC it following positive? the is potential timelines discuss Regarding and development in data time meeting first just determination perhaps quarter XXXX, that

Harout Semerjian

hear Yes. your Good Good voice. to Ed. morning,

trial. trial currently then will by to which if or recommend year continue Designation you've there's XXXX interim events, from we to possibilities the around compelling at year what and and anticipate, remember anticipate Ed, whenever the the quarter it are happens that the mid-year Utility we by the or either the two our Obviously, discuss have this Orphan the we're immediate Interim efficacy that XXX% really one as to we date as of Analysis. we Independent they by To trial analysis. your XXXX stopping said the, seen of the then? one the discussing end, analysis So as IDMC, Fast at – of the to data be Track part with planned of Committee question, we seen move We company the interim end as happens, end Monitoring the if already Data the un-blinding with we FDA committed very meet

to that, Fast Ed, as Breakthrough So sure that so Track we're course rapidly regulatory part make of with moment happen tuned. stay really move to forward and we and that is regulatory of we waiting our team the for ready and Designation, want pathway our

Edward White

you we U.S. thanks. of be potential should the potential discussing Okay, a did And the opportunities the How good job U.S.? outside in opportunity thinking

Harout Semerjian

course, first Yes it's first the focusing of between on Ed we're mean, U.S. the obviously, the the largest enrollment the with as a reminder trial one, but opportunity U.S. I is its and and largest in given balanced and everyone, well for same time ex-U.S. at market the our

as as ex-U.S. and enrollment significant well. patient medical have activities, we So well of in terms presence

maybe for the plan But So would maybe focus of on you the want add the of do we're will a in some U.S. couple be, of ex-U.S. thoughts activities the or forward to ex-U.S.? color we Ed moment moving Bruce, then

Bruce Johnson

getting thus data their Yes, current in of globe. feedback development Ed. reception experts very continuing around mean, encouraging thank I We're on far engage we're the you, medical program. the to our

the all regulatory of certainly discussions and on globe. exploring cetera. ongoing partnerships, look well all certainly say keeping authorities as, with as would in have options that, Europe the we variety do as the are opportunity in also with for et options we fully a uproleselan. markets we registration around at potential to I we're But table, mentioned, pursue major plan Harout As

Edward White

in be last regarding indications? thinking perhaps potential you're look be after XXXX? and And suit that potential if how for now potential this well Thanks. about can looking these at I question see follow approval the the just perhaps waiting at something there to company may, Will ISTs, something to the or is we should you we the and

Harout Semerjian

we're so role has as play AML. a what doing the treat across a we're really everyone, in to treatment pursuing, all difficult Yes, uproleselan we from the to Ed, AML, that reminder naive believe secondary basically populations for to naïve,

our So really from trial pivotal the sure plan we that is AML. in regulatory pathway, pursue a to refractory relapsed make

standard our we across these uproleselan are These NCI have both at is profile anchor. high because the the really populations frontline and a trial of I And it's moving ISTs opportunity different different role efficacy, all, therapies that's the as have peril trials, low these that you all AML are then speak. in has really really understanding populations. medical setting. Remember, generate if uproleselan So And that pursue we it there of the then that big that the is additional the registrational supplement adopted the is levels. able data toxicity grade And maturing, an and AML uproleselan, additional unmet subpopulations. to are and would need of are of to say, to to advancing across to be maturing believe addition with potential other additive the

So significant make our idea uproleselan the the there of we to is will program possibly to we is trials. beyond market, data want development a relapsed then advance get opportunity with pivotal really sure first to first whole but as is we the clinical the Obviously pursue indication refractory. emerging, what

Edward White

Great.

Harout Semerjian

Ed? help that Does

Edward White

It you does. very Thank much.

Harout Semerjian

you. Thank

Operator

[Operator Instructions] All right.

there hand back I'd to are call questions, no As Semerjian. the like more to Mr.

Harout Semerjian

to for Thank today. joining you, Operator. you Thank our call everyone

upcoming with at look operator. Stifel several Back in forward presenting Thank to many month. you conferences, be then. We investor of also you very will London Jefferies much. including and speaking this you We to

Operator

concludes today's That call.

may You disconnect. Thank now you.

GlycoMimetics (GLYC) 9 Nov 222022 Q3 Earnings call transcript