GLYC - Earnings call transcript Q2 2019

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Operator

Good morning, and thank you all for joining GlycoMimetics Second Quarter 2019 Conference Call. [Operator Instructions].

I would now like to turn the call over to Shari Annes of the Investor Relations Group at GlycoMimetics. Please go ahead.

Shari Annes

Good morning. the of highlight second will we key XXXX achievements quarter. Today, the morning release company's QX under we press on website tab. issued www.glycomimetics.com, the The on this our available financials at Investors is being recorded. This call is after A dial-in be of will phone call. the XX available the close for replay hours Relations days. The will Investor available company's the in be replay of website webcast the also sections for XX

Dr. Officer; Chief today on GlycoMimetics are Officer. and Executive the Financial Chief and VP call Medical from Thackray, of Brian me VP Senior Joining King, Hahn, Chief Senior Development Helen Officer; Rachel and

We after will start today's of call an with comments from that, Rachel, will the and position. Brian company's financial overview provide

open call will Q&A. the then We for

today's like forward-looking will include on I'd that statements remind to call current you based expectations.

but the GMI-XXXX, are or statements as and as development Forward-looking website, Pfizer, risks Such judgment GlycoMimetic's not no any from information our involve undertakes and GlycoMimetics or uncertainties. update are could SEC, to that GlycoMimetics SEC glycomimetics and the concerning statements obligation statements. for today contained development represent other to management's intention partner, the which pipeline for as known with limited affect candidate, about Please the on refer forward-looking of filings on assumptions, to GMI-XXXX formerly the risks and the and available for revise company. product our commercialization uproleselan, rivipansel, include, call licensed plan statements as to, exclusively well programs. this

now I'd the turn over like to Rachel. call to

Rachel King

top earlier announced in completed expected data current May, their line to now plan In release occur and this to rivipansel. Pfizer's enrollment. In of that of Phase for highlighting all us second Today, like by earnings that I'd you for you, the had is indicated readout the updated study they Thank expected III morning. Shari, Top their this achievements. to thank joining week, from call is we our the this all of pivotal Pfizer call and quarter's quarter. begin mind

details eagerly the We're coordinated it living that, the achievement, on about rivipansel be remain news impact we as from unable of results. potential with positive, say, to you our could will Suffice to this Other top with sickle Pfizer line we await and around communication significant a enthusiastic disease. that than more have if I'm give cell partner. people

Currently, the there is only treatment a drug in an rivipansel vaso-occlusive than would late-stage the first and no treat testing is it for drug other acute the experiencing investigational indicated patients for If to crisis. opioids, approved, be ongoing setting. crisis,

a differentiates the new a that prophylactic underlying other challenges crisis, targets of and therapeutic avoids of Importantly, option it nonnarcotic selectively the be approaches. cause dispositioning would rivipansel from alternatives

the that clinically are argument. compelling we being program the could part a as pivotal Furthermore, endpoints evaluated believe that meaningful pharmacoeconomic of support

would this positive believe strong for proposition therapy. For data underscore value payers, that reimbursement novel and we authorities a

Clearly, sooner treated be reduce rivipansel the is currently their economic case. clinical hospital is use and than the can there both with opioids to leave and value able as of patients

in with vaso-occlusive poorly possible understood be dissatisfied living for is extremely poorly is disease These their the an blockbuster cell care years know are of billion. their setting. sickle crisis We current feel level that peak with a as responsibility. annual public their acute often recent will of with back in commercialization disease patients acute and statements, know, a $X patients rivipansel you managed events. As published sales described than few Pfizer's greater potential article And from

that could suggests utilization. health option a approved, indicates new rivipansel believe need medical the care patients their nonnarcotic and if would well level for transformative We were physicians that to a unmet this and be patients vaso-occlusive This disrupts that event, high both us of increase alike.

need that for and value medications. an nonnarcotic may effective patients earlier a to Another more this of the if our that decrease Thus, to care hospital in could the that may is comfortable belief becomes expanding consensus seek change come rivipansel the seeking nonnarcotic the progression market patients paradigm treatment in patients treatment option resulting Simply it's that could behavior for drive IV strong the care. the effect, key their more is with put, patient opioid could above namely crisis, rivipansel change treatment of commercial factor expectations. actually available, differentiating be that it

with While our be outcome as goal would the rivipansel ways been the in Phase in positive this devastating has a patients improve lives other well. disease, trial meaningful always to of III us to

and sales, to very which double begin the and allow next pipeline go the regulatory further accelerate to acceptance development trigger to sale of the first potential candidates. they and a would to progress payments the with our low U.S. sales low drug, from milestone for the based together that, the positive are payment us due product up milestone rivipansel strengthen of us excellent drug $XXX our of teens. already development, and in also on After the EU. eligible of in million position digits payments, milestone The royalties First, development royalties GlycoMimetics further The of novel NDA. meaningful in may to on financial an the milestone commercial upon regulatory commercial milestone payment we're payments the We're with in data entitled aggregate, based on

would Second, field an leadership value of of positive of our glycobiology, targeting of our selective the It in unique as therapeutics. space, our source the the platform. untapped of an emerging confirm as would value glycobiology reinforce the novel well and data

III the AML. registration is Breakthrough Therapy patients trial in under Europe. pivotal U.S., patients at Turning in sites or the This now already Designation, to enrolling and it's uproleselan. the in now program and refractory now This in with relapsed trial wholly-owned Australia, Phase is

in We patients continue well. -- treating to Canada geographies, in X patients shortly open treating we and anticipating sites and we anticipate all as

that in and in our company-sponsored our one in explained consortium, U.S. namely Europe, to the in different beyond collaborate X in to uproleselan strategy We've trial. to registration you calls, populations AML evaluate targeted prior with one other

the newly AML, to among untreated for X diagnosed quarter, pivotal initiated by is that are This in with fit announced uproleselan second Importantly, enrollment previously led planned, late-stage second initiation the the trials. intensive our clinical study evaluate patients being in we has study chemotherapy. MCI, who

by AML investigator towards We're feasibility surrounds The Europe a enthusiasm encouraged that for trial progress unfit its HOVON of the and to diagnosed initiation it. by consortium chemo. in in newly continues patients

programs, the totality could across Phase data uproleselan we broad care expect continuum we America, studies to NCI from or Europe results in over Across XXX are treated the and evaluating AML. our a positive, patients plan in GMI, these label and If clinical support II III programs, the Australia. HOVON-sponsored have of of that the North in

initiate in GlycoMimetics GMI-XXXX, a clinical we third advanced with trial program, second for patients metastases. announced cancer breast plans quarter to bone as the

This as broader be year-end. As inform we trafficking center you initiate involved study Institute. spread. GMI-XXXX and are used metastatic done markers Duke into targets program of that dose Its this will trial single Cancer a in the activity is to a know, pharmacodynamic mechanism being dual of Both in of Phase inhibitor a tumor and cancer. at II evaluates before trial results We these and the escalate, plan to proof CXCRX of and is E-selectin. safety

key Nature part breast and cancer that in bone. focus Cell E-selectin rationale that is tumor reported for metastasis studies to showed in was issue our Biology, the to reinforced The growth on of by April

how most engage for describes outgrowth. paper E-selectin, the notably propagation specific Specifically, cells Tumor stroma and components,

we're into drugs, In first portfolio and summary, efficiently relying on the was on the of resources from our our investigational progress clinical without important in XXXX, development, XXXX. In forward made potential financial to have pleased payments rivipansel. us advancing of milestone half is take focus to

platform. a in place programs stellar pipeline to robust, the from company's And have Our we deliver is results. team with stemming GlycoMimetics specialized all chemistry

over Let who financials me call review with you. will to now our turn the Brian. Brian,

Brian Hahn

Thank Rachel. you,

company's expenses with related clinical This III uproleselan to million by the or AML had the of equivalents trial XX, million The parties. and June clinical for quarter compared to $XX.X conducted of quarter $XXX.X was of and primarily cash increase million collaboration in XXXX, development XXXX. as increased the XXXX. As the million $X.X supporting ended $XXX.X December and result XX, XXXX, of uproleselan second the Phase patients, as June third XX, research trials to of to as in compared company's cash for relapsed/refractory GlycoMimetics of expenses of

The XXXX, as XX, company's ended general to The and compared increase administrative higher expenses quarter increased compensation to the million expenses. June $X.X for quarter was to million noncash patent for XX, stock-based $X.X the XXXX. legal and due June ended

to in I'll is financial turn GlycoMimetics planned to initiatives summary, an the over position novel to call pipeline. advance out carry this and excellent back In now Rachel. its

Rachel King

Brian. you, Thank

the of in AML of rivipansel year of now for X X transformative the in readout be we're sight second the and confident recruiting, half that actively trials With will us. with key

for whom we series strategic to deliver diligently. with accomplishments is to continue collaborators, and goal the employees patients, a Our value-creating and for caregivers, whom of work

With the Operator? that, I'd call like to for your open questions.

Operator

[Operator Instructions].

We Ritu first with Cowen. question have Baral our from

Subhalaxmi Nambi

is on the rate, for is seeing This be rate? of then, screen was if drop-out wondering And same patients that I originally would you Baral. had Ritu Any refractory/relapsed the Nambi you're amount what Subbu helpful. assumed? color failure

Rachel King

enthusiastic general response the comment? trial. to like seeing around you we But comment Helen, I'll would I'll are of Helen. turn investigators that make to the

Helen Thackray

Yes.

is relapse enrolling population, Phase high-risk the the including and we are both So trial, a a that refractory population III the group.

And balance, Phase seeing a trial. and to the population context to is We on did antagonism II enrolled. eligibility high-risk see respond for to refine I that a distribution selection are think, so the We good focus criteria approach. in slightly, most patients the a this trial, that in patients far the to those this do order in trial, likely we similarly

Subhalaxmi Nambi

I your because data effects And mechanistically question. its Like watch we might something readout? in gotten missed side increased the III more blood out cells, for volunteer which you of Did small healthy any size. in study for II in the I Phase white guys Should it. follow-up in Got have have cell? see Phase Phase sickle one

Rachel King

both were Phase safety II trials. I profile drug, pleased, We we Phase very the with in in the saw that obviously, and the

that let me again, color. for further So turn to Helen

Helen Thackray

Yes.

studies being what safety studies, impact the There a in I assessed program Phase And disease assessed been profile, some early Phase then would a There safe have nothing III concern the Rachel from and the so -- have of patients, throughout to also early are biomarkers that were and III further profile recognized in program. any those healthy is program reiterate cell consistent in benign in said, a the demonstrated in identified and that the rivipansel. as so sickle observed volunteer on Phase studies were perspective there's very a readout. in for activity just

in about sickle blood in otherwise was levels similar and That Phase or Phase In cell white blood concerning in remainder white either that, that expect terms in our with of a I variability would differences of cells. patients to variability any trial, the with be disease. observe of not did I question the program. the There is We trial. cell we present the

Rachel King

in III. would the enroll enough FDA that that the did II I the down Phase in to Phase was safety that we HX add the profile were to able agree encouraging

Helen Thackray

add terms would one safety level. any for risk I in And comment program the addressing of potential

with have for by standard program, the and there with there standard a group. independent throughout process, oversight to signal DMC and safety safety, is review untoward expect has observed to procedure. Pfizer think pivotal DSMB about trial or the program identified. of If concern simply been proceeding As a is any would concern followed the any was Pfizer I that no a And is has oversight that in that independent so closure a trial the -- we

Operator

comes with Your the line SunTrust. Lawson Peter question from next of

Peter Lawson

or on should XX year next be at readouts the Are could just and data data we so. any Rachel, that potentially the next there have thinking ISTs about looking over that months? for

Rachel King

opportunities disclosed become ISTs. look are ISTs. uproleselan, are current say current expanding will of advance, use but haven't any those we we've that to not additional the will continuing for I announced and -- with We as as we you we -- any for they share they

Peter Lawson

Any potential or just the the on potential your of on Rachel, rivipansel. from then, appreciated. thoughts uptake be crizanlizumab of around And impact would that use -- thoughts Novartis'

Rachel King

selectin have -- One actually, crizanlizumab. a Yes. the believe, comments also I two And only all, noting I antagonist. I'll it I think are that, selectins, it's make is first about trial targeted trials the been worth of be that have disease, showed clinical that multiple Phase and target criz II. And benefit and are randomized clinical where and that that cell in sickle controlled. have the our selectins would is their there

been least, disease So I has can the confident that we well the target, sickle cell think importance -- feel target the in has at established. of been

think there could that on patients a that It's a With of use I possible think for the the present time, number there up don't -- adequate be of which be could an we market needs, be respect increase the in at could crizanlizumab. is the be we of And are to bar if becomes acute impact that address the uptake, result in crisis chronic therapy. in patient's the with significant on patients to slight the goes as same setting think treatments available. expect care reduction to rivipansel. one for who if there's seeking there of I going that number patients more the rivipansel But the

virtually has I'd actually, of crisis. been from emergency on see patients hydroxyurea, to if crizanlizumab, comparable impact for at hospitalization data also they crisis. the occurrence since of market, on at of hydroxyurea think the the add you impact reduction no there's -- I presentation that back had, both for vaso-occlusive the on room look for been you'd that And

So and treatment crisis. market remain for I think of is going that important to our intact the

Operator

next comes Brill Your question Danielle line from Piper with the Jaffray. of

Danielle Brill

I coordinating you're disclosure around you Rachel, plans of the said data. rivipansel know

your before this, whether the the of getting hear heads communicated you're questions rivipansel? from also, of risk there's with are results at failure released? And see much Modus' up and a And about investors sevuparin. Just you Pfizer? counterparts been to of on curious you Curious when expecting we've lot for last take a your recent a how

Rachel King

Sure. Sure. Yes.

normal would things partnership. partners communication a communication would you I type an expect as things the open if the situation to this, expect be say, as in might normal of between like I again, As are good expect we far you'd coordinated. And course channel, and proceeding with Pfizer, in with it's communication of say, a as in

fail. target P-selectin sevuparin as targets effect, X, really does analogue, L-selectin That recently actually rivipansel but -- a concerned, is course, what because is of in a E-selectin. other E-selectin of the that literature, is lot the targeting of But and a that clear, and that pan-selectin far I of work key particular, observations, And the antagonist, other And GlycoMimetics. conducted possibly the actually we a potent and believe but a it's which investigators think independent by that's in not did in through charged heparin As was in yes, actually itself. a development there's in in all been importantly its is made point important of through view, E-selectin. targets hands our exacerbation crisis as

E target rivipansel does. not does sevuparin and So

rivipansel unexpected So we to a don't and think fails view our have in any that, it's that crisis. would actually target impact E-selectin not no in that to has that read-through compound

Operator

Stephen Your next of the line with comes from Willey question Stifel.

Stephen Willey

to of your about XX% that if of Maybe for it's a responsible succeed I receive III, rivipansel think crisis? XX% some Rachel, Phase expectation if curious And that just genotype-specific if for among so, would it are of how impact utilization the label? genotype does the patients if in some other may

Rachel King

by any could no, don't Actually, be there Yes. genotype. limitation expect we

Stephen Willey

the you what can for in sickle remind is And just DRG current Okay. patient payment crisis? cell us

Rachel King

Actually, current what know I DRG don't is. the payment

et the is and so around the cetera. Pfizer know, in process the know with they I they're as expect you issues launch they all and the are reimbursement, issues. commercializing of of be, actively marketing, would handling of you'd associated engaged As all do reimbursement drug,

Stephen Willey

Okay. us XXXX And then, to I guess at you've ASH. introduced

from Phase the is that prior clinic actually Phase a do curious move AML how readout? Just to away far III And into asset? I that you a

Rachel King

to continuing toward our animal exciting of I XXX And the actually take going product for we comments, be respect preclinical we actually. we an That as could models rivipansel And the into that, binding. do that given in a -- uproleselan guidance go a are the the than objective. is in with advance my in prepared readout. we've suggest E-selectin into clinic, of that different times models to prior not we've think seen on. about but to or but could that that work could, to number And are clinic that And when excited us. potential quite III to more actually follow-on we're activity we potent as really X,XXX mention didn't that It that that. Yes, to than continuing we're specific Phase fact, to in is follow

Stephen Willey

And then just one last clarification question.

receive in So study, I consolidation X? III in Is allowing it the Phase for with number -- AML patient a know capped? uproleselan. can Is you're the cycles of are consolidation

Rachel King

Helen for leave I Helen. ahead, to... Go

Helen Thackray

point up the not often would protocol, the consolidation. often, expected use transplants X, them all that transplant. for of who Yes. for readiness to prior that. go especially allow is patients Consolidation given get to for will sometimes do to and therapy, in patients eligible to In of It's cycles X cycles necessarily cycles, to the one, X are in transplant we patients standard X

Rachel King

really Sure. is I we to opportunity to extra on these it exciting the would us protocol. of add that that consolidation cycles have have

all Phase cycle as study, the that encouraged were And of very results a were one therapy, that patients we the our with uproleselan. reminder, So almost trial. only in saw by we II treated with in of

we the to multiple So placebo protocol for differentiation group. continuing could opportunity potentially cycles treatment add and the that between the the on think

excited the of study that So aspect about design. actually we're quite

Operator

from Your the Amin comes line Biren next question with of Jefferies.

Biren Amin

Rachel. from release the How are to Just announces top much going to Pfizer expect on when -- data? the press III, line rivipansel that Phase data we receive that

Rachel King

meeting scientific companies of to typically available fairly see line what top some the further or around details publication. that the which expect can kind meaningful at do situation, would and information similar comment something in you some a in think I a to be be So would

in fairly think I you something expect that typical can regard. So

Biren Amin

be going is III I then, a endpoint? on ITT? the on Or Phase modified going to ITT there just primary Got analysis. Is guess, to on the it. be based And it

Rachel King

Helen So we're say that, initial now to I be can't but I disclosed don't fairly disclosure And more initially. describe high right think if going I level. will know about the exactly what would can be --

Helen Thackray

that, a ITT Yes. specifically, think can pivotal based I I say answer generally, we would don't could an that And analysis. but trial be on

Biren Amin

cancer And us more that Got can of just terms you provide XXXX, enrolling, it. in type patients But what trial? breast give detail on you of -- on then, are study?

Rachel King

turn enrollment, to Sure. Again, of patient I'll for description patient the the Helen, detail.

Helen Thackray

of proof mechanism assessing markers. is study that for and pharmacodynamic for So

bone are -- of we CXCRX cancer order that, including metastasis, use assess the potential and we'll on aspect is antagonism metastases. particularly a For and disease, with of breast bone impact in E-selectin stable to for bony enrolling enrolling metastasis with be patients -- the on of important the We that, think GMI-XXXX. that the

of And so the ability for things looking metastases, around well, data and perhaps circulating therapy. including in to disruptions of -- pharmacodynamic bony setting counts effect also the other And be that. increase like like markers the We'll process. metastatic tumor cell assessing under things bony detect on the of

is We of on. markers the we'd also might know and program inform looking for that, hematopoietic cells, affect that of that. aspects be later that one can stem other also It mechanism

Biren Amin

to subset just guess, negative? of for terms triple going patients in example, you versus, CXCRX, I ER/PR-positive you confidence So subsets? that's E-selectin other why What work dual in chosen gives this antagonism versus have of and like

Helen Thackray

or question. we effects would And another. a potential to That's that be one or population think limited the don't great the benefit

who could stable of patients Ib therapy are because assess We quite to that be multiple mechanism the therapy terms in cancer. have But on setting of to access to of addition early for proof in appropriate types patients part molecule their study. breast clinical we for think tumor as relevance relevant for this with us metastatic of disease exploratory this in population an the and chosen Phase ability and the

Operator

[Operator Instructions].

with the question comes of H.C. White Wainwright. line Our next Ed from

Edward White

Most were already. and just, follow-up maybe, of But a them asked answered on XXXX.

to patients start for data? Ib you're in the the half the expecting that Phase you the of can number 'XX, enroll? to us any expectations And second With of also, give timing

Rachel King

will a Yes. trial. be This small

would So we it than some of have hoping patients, by less and dozen will readout XXXX. be the data a be end to

Edward White

AML provide to and as might own the enrollment progressing? on any with going just kind study, And you updates maybe difficult I but able is to Okay. NCI then the of to study? Are trials. it with enrollment your how other know be be

Rachel King

Yes.

you details enrolled. So going work be we'd so that. many readout know. our to how timing any are -- But to is as timing But around on -- we're not if the impact and on objective to toward time patients providing there's that lines, data to let issues focus

Edward White

Okay. rivipansel. on And then just lastly, maybe,

Following Pfizer, release the hosting call? by top your do plan you on own line conference

Rachel King

be release beyond going I a -- line as we're -- going set, level context to in of not data scientific press a don't what's meeting to in release or the the a top broader not there's So is think to some the a at publication. detail be to in go that's I again, said, we're going of opportunity share until

to in a because So conference I release. what's do call host separate don't to going to plan anything beyond currently we're we able the be believe don't press

but I the that terms and questions calls, think release disclosure be time. that with the in sticking to I we're in take what's data always said, being press happy at we'll of mean,

Operator

to I am would no go time. the at to this further like now Rachel. Please turn questions back ahead. conference showing I

Rachel King

to We you, appreciate questions your the Thank interest you. everyone, call. and listen time your for taking the Thank the to company. Great. for in

Operator

for thank you today's gentlemen, This in concludes conference. and participating program. Ladies today's

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

GlycoMimetics (GLYC) 2 Aug 192019 Q2 Earnings call transcript