FMTX - Earnings call transcript Q1 2021 | Forma Therapeutics Holdings Inc

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Operator

Welcome to the Forma Therapeutics First Quarter 2021 Financial Results and Business Update Conference Call. All participants are currently in a listen-only mode.

Following management's prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this call is being recorded today, May 14, 2021. I would now like to turn the conference over to Mario Corso. ahead. go Please

Mario Corso

by financial This Relations operator. and Corso, I'm Officer. Director Chief quarter Chief Todd Senior our Lee, our Officer; to update. Shegog, Thank Officer; and Dave Forma. is Good Investor XXXX first review at Cook, call listeners, our On Executive joined and President morning Pat of business today's you, to Financial Officer; Mario this Frank call, results Scientific Chief to Kelly, welcome Medical and our our Chief

begin, Form facts I'd and that Any this SEC future forward-looking made are guarantees forward-looking on during be uncertainties. we for Safe from includes this like not our statements, ended call, Before and our the X-K. to pursuant quarter in various XX, The the our statements with our comments and financial conference subsequent or to caution Frank, statements and any made and those are those provisions statements certain intended revise year or during are forward-looking ending Officer. to and of the the required to Factors trials, listeners estimates, are filed emphasize belief, of will risks current success Harbor Private relationships that forward-looking nor be update XX-Q XX, and these Securities that timing, ongoing Act with of December our therapeutics, implied I Form efforts, information heading on neither including operations, benefits Chief our of to turn Risk Actual potential Reform current data of uncertainties provided clinical regarding report applicable XX-K subject and statements historical clinical Litigation and potential planned want March safety reports announcements our to development, obligation law. XXXX the today or XXXX. the associated by Form on our now statements. that of any expectations forward-looking assumptions, under President events the collaborators, reflect results business with third business impact including COVID-XX or development financial will in parties our current for such differ and and current and by risks quarterly the stated to regulatory submissions, thereof, clinical condition, We and Annual to and as Executive performance. Report on predictions Due statements, disclaims XXXX could company entitled our over materially business, and except call the reports call, are

Frank Lee

a every key our patient make talented Forma. it live and before Good you for Thank say and for for guiding believe, culture I'll time, the to first and remarks. you, on share thoughts with us I hematologic our how which employees And by more our make with over strength, to our our we our to principles employees, some pursuit disorders is and who purpose contributions differentiates values of and possible of quarter proud and R&D of rare you that high I'm And Pat morning, to they and living pleased cancers. pipeline. acknowledge today's lives pandemic in the by the like detailed I'd strong level Mario. purpose. focus Dave day patients, effort it progress continue everyone. healthcare turning call. our the to workers is I'm posed investigators, to are made first And in us challenges patients COVID-XX thank and with navigating pursue joining transform

castrate FT-XXXX, We quarter. and our pill. the Phase development hemoglobin milestones once resistant that vaso-occlusive oral with for potential prostate disease in X/X being activator daily the developed crisis therapy to for a Starting a both PKR cell in enrolling quarter, potential disclosed achieved first programs During we FT-XXXX, patients in the FT-XXXX, benefits Hibiscus provide for foundational Study metastatic began sickle oral important the cancer. our and first two CPB/pXXX with our inhibitor

in at have may events the were benefit indicated In placebo and addition, the we two Phase the dose no responses - duration toxicity end XX our or the best treatment days. takeaways which Number from XX or longer one, in improvement adverse as week responses trial, key significant the red treatment typically X treatment been second two, disclosed MAD the The completed two health. biologic week hemolytic the randomized initial portion hematologic period, an blinded results related cohort multicenter identified. effect, follows. were from controlled successfully And limiting of a beyond consistent of day cell Number in patients blood suggesting trial.

extension. cancer, trial with the XXth. potential trial program diseases. are the the reported to of with getting in completion first the and in X the evaluated initial European see forward available for trial moving label oral MAD the the XX-week Importantly, discuss Phase rare label needs, we the forward this allowed as this Xth the are and interest variants in or half look XXX for milligram together of we next provide in to thalassemia the medical doses to presentation program metastatic And XX pleased June for treatments. resistant of to trial, this the meeting the FT-XX a now specific as in patient no centers underway other call support next this quarter, We're results year. first castrate this Study. Pat? in prostate virtually, MAD Association, well cohorts on ongoing the the to milligram and currently FT-XXXX, and over both being finally the be anemias, more taking the expect the early dosed the We year. there for review combined during second and year, splice Pat through steps more patients. turn with continue respect particular, from milligram results olutasidenib trial hemolytic CPB/pXXX the X/X taking open internally initial in including FT-XXXX, later With the inhibitor ongoing MAD will Phase the little with the initial among Building populations patient which and patients detail. extension And the to of of unmet ongoing as XXX in quarter of Hematology fourth results data trial us high to AR-vX a sickle ongoing well date to as to place cohorts cell The benefit the cohorts, unblinded our XXX phase I'll open hibiscus EHA at

Pat Kelly

delighted with updates refractory IDHX you, with for on to Frank. two relapsed treating treating programs, with AML cell sickle for FT-XXXX morning, And our an I'm mutation. of or Thank olutasidenib good patients disease, patients provide everyone. and

As the demonstrating Frank pleased well XXXX very tolerated mentioned, with cohorts a we was profile. completion are the safety two FT-XXXX favorable the of program with dosing week that for MAD

LDH, bilirubin, and the saw These the also benefit day surrogate We blood in other period experienced a gram improvement of the at one in cell markers. of of XX% treatment or indicating in important reticulocyte red the all and patients patients nearly end hemoglobin include the health. counts, XX the increase greater

providing the and XXth. analysis the at from will the cohort. two results for XX the presented the initial analysis be FT-XXXX a be dosing receiving complete unblinded beyond the week of Looking cohorts forward, EHA through week we MAD we weeks open These place of label June two will first time meeting of taking an patients disclose the X extension annual will

this have regulatory pleased approval to additional a trial, weeks designed for with hemoglobin and we X/X rate study to potential health, which separate like indicating of endpoints, accelerated our an in feedback. approval the the ongoing VOC's beyond FT-XXXX design red week with opportunity the regulatory is to includes that a positive. Phase regulatory studies support reflects to XX reiterate with two cell guidance be the in following of VOC's. rate primary full improvement. combined FDA change of the consistent XX functional hibiscus in emerging Hibiscus support profile treatment study potential are of benefits and also The would haemoglobin of expect is on We We improved RBC data Altogether, supports of reduction take

respect to anticipated enrollment planned with our trials begin and the well, the to XXXX with and progressing cell are Finally disease in disease. half FT-XXXX, sickle with cell of thalassemia of first second in pediatric for patients in thalassemia sickle pediatric half year this

phase registrational the being the our trial. a AML. olutasidenib, one October to with announced relapsed primary turning response mutant of in we rate successfully durable inhibitor leukemia of refractory interim last our complete acute in evaluated analysis myeloid or IDH year, Now this In met endpoint that patients X

the We in presentations to for are annual EHA ASCO been June. meetings and that announce have both pleased accepted oral data these at

a application now the a FT-XXXXprogram update of In addition, going new to prostate on With NDA, call on to our preparing work filing to provide drug I'm the an or over US who turn the that, FDA. will Dave, for an cancer. continues

Dave Cook

AR for shown tumor the In AR dependent expression. has of to expression going a care receptor to mechanism next FT-XXXX pathway targets to the antigen the lines, been few standard of I'm seen FC-XXXX stage decrease AR resistance by the decrease discussing that clinical inhibitors. has also our spend many Pat. Thanks, novel CPB/pXXX FT-XXXX. minutes inhibitor, mechanisms potential cell signaling and gene address

addition, treatments. accelerated including broad after vivo. xenograft lacks for and has that to to no FT-XXXX be shorter inhibit treatment, a XX% in AAR-vX approved cancer in AR-vX with detectable XX% suggests been FT-XXXX may resistance and an path model to cell is market. the there believe substantially of patient-derived correlates of approximately overall splice In the which observed in survival. We in mechanisms, domain, in Activity men expressing data prostate AR could are variant, and proliferation represent action which binding to of a of cancer the applicable hormone it AR-vX range third-line Published vitro mechanism

lines as as cancer well use AR In addition, believe of therapy, triple breast such negative we dependent earlier as other potential cancer. has prostate for FT-XXXX in tumors,

of titration expression enrolling X week tumor quarter a XX tolerability with one phase doses and Circulating markers including of planned tumor will year. men as of many AR-vX one cancer, cells radiographic levels, in early higher safety dose XX up castrate the resistant assessments prostate with utilizes predefined six off on is three who and more include week profiled design, will upon burden. clinical standard a genetic cycle, PSA milligrams, be of as lines this will care, based measurements to fail began and to criteria. and enroll adaptive or of with it on, first of resistance This an trial to trial starting Our metastatic

subset underlying a may in an clinical expect to initial are results of fourth PK/PD, biomarker tolerability, More preliminary anticipated quarter results in safety, of year patients. and response have genetic XXXX, These data. rates trial the and of responders. results We tumor of including the characteristics in this complete assessment from include

unmet promise our Chief [ph] of the Given we now men, Financial Officer. in they of the and the as of sharing FT-XXXX, available. forward high this turn population our call to are I over data the molecule, novel look become regarding will Todd, mechanism enthusiastic need and to

Todd Shegog

And you, minutes you our quarter thank discussing first then position first today's and will us our the Dave. everyone on results spend discuss and outlook. financial for of few call. XXXX joining cash Thank for a I

in ending $XX.X million, change Discovery million in on loss of expenses time first largely to gain the net net net were compared X/X was the of trial with and - development our the XX, in two $X.X the million of insurance trials benefits XXXX. metastatic Hit costs company, was increase XX, XXXX for of expense This XXXX. of million FT-XXXX X cancer. to progress including for March was expense. income in the and cell quarter start the for administrative reflects fees disease being FT-XXXX General X the compensation supports compensation XXXX. $XX.X increased with capabilities The quarter quarter divestiture to and for in year-over-year and development, sickle million, for ending spending loss $X.X XXXX. Phase million the in quarter including first increased stock XX, Phase public attributed and quarter March attributable compounds our and This which March $XX.X one expense, a Phase prostate related Our a quarter the versus Research income quarter the in $XX.X the and ending tax compares the as professional in

the at million, equivalents $XXX.X working million net first end year XXXX used quarter Our loss, capital. and as cash, marketable cash well XXXX. March Cash balance securities reflects of as in changes was XX, compared to $XXX.X in as the

as extend ongoing we we through continues cell upcoming strong are planned pediatric Our clinical the run includes important FT-XXXX can of and commencement population. thalassemia, a XXXX, development which sickle in as rate take to cash questions. through of and clinical financial trials, now position third quarter in be well current to Overall, continue Operator, financed milestones. well

Operator

you. Instructions] Emma from First Cantor [Operator Fitzgerald. Thank question Nealon comes with

question please? Your

Emma Nealon

morning. good Hi,

can at that label the hemoglobin expect a over this XX data period toward response whether XXXX, treatment for So two response open saw first the longer increasing you the the speak And over better periods trend to day you potentially you treatment for cohorts? to see EHA? just in

Frank Lee

forward we're which will the over Certainly, XX to provide to And of data provide weeks. completed label Emma. [ph] have let weeks for at have open me high will the Lee, of now completed first some data extension the remarks a just additional primarily it and and looking is we some various level Hi, two treatment. Thanks Frank thoughts. turn Pat from XX patients, for two the And some for will look to here. have questions. anywhere cuts weeks, certainly some

we'll we studies. MAD from have of data spectrum a two patients. certainly in early what we're the by And so And encouraged the saw

Pat So thoughts additional to let me some it for turn over there.

Pat Kelly

open patients Frank. Thanks, week know, two rollover the were in the Yeah, first said think it. key allowed aware weeks. of XX milligram people XXX is disclosed patients group here as that he are into we - MAD Great. the the the as in you And previously we enrolled into out or cohort, from label. six MAD I Well, rollover two to nine did participating XX

versus in will XX their you be on [ph] if will, we two based So exposure know, in experience in have, greater experience to two week week comparadent week the that cohort. able the or their population, comparison, you two a MAD in

Emma Nealon

Thanks. helpful. That’s Okay.

Operator

you. Thank

with next Our question Andrew comes Berens Leerink. SVB from

Your question please?

Andrew Berens

addressable And are some acute guys. that's And from do couple by Good or if or Hi. into I I many you how class? and hemolytic you morning, on decision anemias, please. wondering these question cancer be guess, do the color inherited, then treatment? have think us would acquired give A chronic the XXXX prostate okay. program was on PKR a If I me to go the the afterwards. could

Frank Lee

Andy. Sure. Thanks for the question,

PKR we'll looking Certainly, PKD. we're made going but share of we'll is of know, that yet. second our So areas any and looking through in one particular you more Certainly, [ph] we the analysis, the at, that and through, half agonists in year. look that's at there are haven't decisions other the one

thalassemia. the doing disease current be the and And to to to just more there's sickle speak, we'll time, so, the cell we're focused than at - think more in of we share just be analysis, year, our information have half and certainly but second on potential so

Andrew Berens

PKD also, potentially it's area? more because broad Okay. than And a very

Frank Lee

potentially. Yes,

completed beyond we analysis, So to there's any but in indications that about make two point initial this we've until potential certainly PK… comments our want I at don't talked

Andrew Berens

Okay.

presented on set upcoming then just And patients the the And AR-vX or XXXX? program. what's AR-vX prostate Okay. data include the pathophysiological all cancer rationale Well, with comers. targeting for only then that's

Frank Lee

me for let it comments. Dave turn over additional that. Sure, to some answer then And

fourth the And quarter we'll late-line around enrolling certainly share it'll of of AR-vX. will have what be some comers, data about we're patients, be initial And all COVID the and whom data. year, so now, we this right

be the And at data. the cuts That analysis. of so we'll have initial will those

additional me to it some over turn Let for comments. Dave

Dave Cook

Yeah. Hi, Andy.

to expect kind don't to said, want may about a drug study the assumptions in interact, and the is an think have Phase what of about delete phenotype. comers the is they that so you or patients we're have where ligand said, We where One, is doing all know they domain, I make these do have meaning we of being we N-terminus truncation, Frank tend number X. where variants, pXXX That commerce So domains is not. and there efficacy binding really we as rationale C-terminus CPB - with given AR-vX that to AR-vX, the The include twofold. protein intact. what know the the splice

the mechanism useful. to be disrupting think should of drug we continue So our by that

really is are can expressing which are second lines cell is for show resistant instance, empirical, The enzalutamide, we AR-vX that instance, for FT-XXXX. to that to sensitive

Andrew Berens

Okay, the Appreciate thanks. color.

Operator

Our next question Fauth from Suisse. Tiago comes Credit with

Your question, please?

Tiago Fauth

Thanks for question. taking the

questions we health see, on some Osmo So that a data up follow data. RBC the scan get might on just we

So just how so something for specific [ph] that is that sickle, single it program. see established it's patient for a or and every want to better little you in forecasting measurement variability understand well trends not bit

any would Thanks. be So helpful. color there

Frank Lee

Thanks question, for the Tiago.

Let a bit and maybe further the give to that. me and little of after talk first color ask Pat scan little Dave perhaps, Osmo bit a on

Dave? So

Dave Cook

measurement is have Well, to has XX membrane Sure. as first of labs, What measurement. was typically in or available indicates is it critical elements to the do a devices well complex it hemolytic the it although validated years, ratio that fairly what what to And been indicates, it's clinical It with developed all, been not It's XXs. has indicates - volume been recently. it of in function. early several for around it because used it of indicates volume, And also only cells. red things. commercial surface are meaning, so

the ion of when osmotic to a leaking levels. high ATP are - leak ions For element And is water instance, out, leaking when under key water water, in appropriate restore ability out. gradients is having tends ions pressure, also tend to

red it balance. demonstrates think to so these to and the gradients, we health show able we're that when handle hydrodynamic ability the of its we cell osmotic And maintain can

Frank Lee

Pat?

Pat Kelly

that as can that lab. one centralize sent the to piece for has are bit is, think of the is assays different of lab we we've all parameters. each a important we've complex be I challenging, But what's other learned these what done Yeah, are samples analysis

consistency variability work, there's just themselves. the based So to we've a the in appreciate be come within patient, on in And might patients yes, between of patient's consistency on that, that that based the individual but there's the MAD analysis. cohorts, phenotypes the there

a experience patient know, patient, time enrolled MAD treatment. have where with a very see a the certainly our consistent the open and who having the in over individual for of phenotype and So patients label, not they're that we period receiving both you

of [ph] cohorts have analysis in So the all groups our MAD is as in of we'll what is, the total. complete part information those

Tiago Fauth

Thank Great, very you. helpful.

Operator

[Operator you. Thank Instructions] of with Breidenbach Oppenheimer. have We the line question from a Mark

Your question please?

Mark Breidenbach

Hey. Good morning, And in guys. enrollment started hibiscus. on congrats getting

also I'm normalize in patients clinic. bit coming the know, data help to back You you And have dip the COVID seeing are hibiscus? during just a to was of especially your suggesting of clinical sickle And if if clinical in I'm plans visits substantial sites any wondering sites healthcare cell a x-US sickle provider in enrollment potentially terms wondering to we've to open patients little there Africa, traffic seen by territories, in cell starting accelerate pandemic. in

Frank Lee

taking pandemic. question, the in guess, it I Pat been then Mark. over the turn impact for and pandemic steps Thanks we've about of terms to let navigate broadly, of the me the talk the to

has impact on First, I'll had the say certainly our efforts. that, an pandemic

to we've patients. non-traditional and to the about down but ways so ways, only really And enroll and had not innovative traditional double think

talking that team's and based been the we've so been the deliver so about far. that, And to efforts, data we've on able

don't the and Pat, talk about so little see navigate we're you we'll far, more COVID been we able a pandemic. specifically bit at to sites? so as plays forward, seeing how And why we've what but out this the move

Pat Kelly

activities the and read countries those is in of not COVID x-US I globally running. can know, countries. US-focused, the been you also various and you know, like how you at impacting countries is hitting, been papers, have hospitals centers the but Yeah, But really Sure. parallel, just based terms getting or what activity in and in the up of on think, impacted really, severity

to vaccines know, have you can contracts. imagine, sites already benefits clinical research. rolled sense you that seeing coming the out, up more approvals and in and we're the our And certainly. have So, that's, of you activity catch in in as are is terms there, already the what These the we've as know, we're really online, starting are for US,

it. is you as So kind the has and we're looking open COVID, - starting we activity guess, US hopeful, the of up, to, healthcare this improved, I is so put in and vaccine diminished is know, how vaccine we're the would

Mark Breidenbach

Okay.

In terms patients? there in sites in Africa, high are of to concentrations cell sickle open where plans

Frank Lee

Yeah, as both own we've and on, have approached, not we're - looking we're we're themselves been that but countries right. CRL, from internal really countries, you but a this we point, resources, as and availability, of it's our the number know, everywhere, - dependent our activities, we're on disclosing we've specific and looking working countries at well

Mark Breidenbach

data And of on in Okay, that clear up got fourth expecting quarter, we're data. it. the include the prostate CTC cancer one will follow profiling the be to program, some just

thing, So therapies, XXXX? sort or come to going in later AR-vX they of status that are that mutations resistance, and is specific conferring point targeting

Frank Lee

Dave, take that and go one. ahead

Dave Cook

don't specific And I part doing analysis that's and depend Mark, it the yet. for been going strategy on how Yeah. gets our batch. of we've think to

obviously interpret genotype the of to results the that's globally. year, the to end So want at the but I important don't commit really data for

So don't around specific have that whether the but we're I data be we're going the think at to available be that, a yet will of end working by year. commitment hard

Mark Breidenbach

it. Got

and on Okay. the Thanks for clarification, the progress. congrats

Operator

our to for would concludes call his I Frank session. Q&A Lee Thank this you. back the And turn remarks. to like final

Frank Lee

We in to everybody. the thank call. today's everyone participate for just want taking to you, time thank Well,

course executing we're and during progress brought patients hematologic these the strategy quarter important year. sharing and to on cancers. new progress The that's in first medicines look of forward R&D our rare the bring focused to to our disorders pipeline And some more

you. a Thank great day, have everybody. So

Operator

day. for you. Thank today's you now your concludes Thank disconnect. And conference. participation and this Good you may

Forma Therapeutics (FMTX) 14 May 212021 Q1 Earnings call transcript