FMTX - Earnings call transcript Q4 2021 | Forma Therapeutics Holdings Inc

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Operator

Welcome to the Forma Therapeutics Year End 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, March 1, 2022.

Now, I like to turn the conference over to Mario Corso. ahead. go Please

Mario Corso

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

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

outlined Frank, the call press today’s would like release. I in upcoming to Before over activities turning to as mention two

in And available virtually March the the turn Review also Healthcare Oppenheimer to and to in holding will on www.formatherapeutics.com. events President participating now be that Chief website Executive XXXX. our be I first made XX these will will With information XX. over Frank, Pipeline be Conference Further We our our May call on we R&D will Officer.

Frank Lee

Good XXXX my for It's as Mario. accomplishments review everyone. our as vision pleasure to you, morning Thank the XXXX for and significant outline well longer-term company. plans the Forma’s in

Annual diseases hematologic is our In rare expanded Phase active clinical Forma’s XXXX, year our the the was completed of and disease for men and metastatic the cell Pat foundational were living disease data with development living two assessing of action. clinical beyond. hemoglobin a people Not multimodal measures These with prostate people Meeting castration-resistant rigorous a programs, XXXX XXXX presented cancers. the support of with trial this the mission, label of a And know, to early sickle and potential the have shortly. impressive cell cancer. building was in to cell transform activator and our affair generate of in lives at a only of daily sickle December. development part clinical with formed Results open etavopivat. from ASH purpose patients to most the latter will you the Phase As mechanism extension PKR on results has stage etavopivat believe review once here its This disease. In we It via living molecule in FT-XXXX biomarkers be analyzing for of comprehensive trial the typical health. numerous conducted results for of living X and program hemolysis X the blocks but trial we to also

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a is company and position etavopivat for advancing Forma’s year success. XXXX development ahead, expanding of the pipeline, the looking of clinical Now, longer-term

pediatric X/X expect populations. and selection dependent decision our We continue development disease of global etavopivat cell include the in We're Hibiscus year. towards interim this also to enroll Phase one, the analysis dose the the and to sickle transfusion end study broadening

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to castration-resistant expect its later current the will FT-XXXX data including and discuss development landscape. tolerability safety for provide FT-XXXX treatment This We enable in profile prostate us approach cancer in positioning the clinical data the year, activity. metastatic updated in and for

for multiple a Finally, a clinical for research building that with to the we're stage this for proud We're year our we to with year plans compound, to year. is strategy we application in sustain molecule. long near relapsed/refractory Forma development, I'm for a partnering objectives. as with new capital of third last assets development inhibitor, AML, respect our and all IDHX continue at progressing this enthused accomplished olutasidenib our about this term positioned term strategy capabilities and achieve and company our that success substantial drug

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in has As turn olutasidenib disorders rare I'll call we recent more cancers. patients living results detail. our hematologic transform and lives go Kelly, with now etavopivat the to pursue the and purpose who Pat? over of to Pat

Patrick Kelly

X,X-DPG. activator with course morning, also were multimodal increased that the a by And PKR sickle reduces a December. distinct can mechanism will potentially Phase of and programs improve binding cell and including at etavopivat presented RBC everyone. believe sickle repairs, and any our agent hydration. polymerization response, disease. ASH overview RBC action hemolysis, etavopivat thus presented parameters, comprehensive selective is including And or sickle that such damaged X,X-DPG is oxygen the ATP improves once-daily and that effects Annual clinical which Frank. XX-week decreased results increasing I reticulocytes December membrane extension RBC the you, hemoglobin, complete Thank In and presented most the of open the deformability, We in We Meeting conventional provide characterization in of study, by critical good were decreasing oxygen disease. measures at the of brief we and as for novel health Etavopivat label binding the of lifespan X ATP. ASH Annual development olutasidenib, cell hemoglobin our of S and the results believe presented sickle from Meeting modifying also

Key sickling the There inflammation, markers from hemoglobin a the was daily disease the in weeks findings in mean that measures the underlying the reduced to at a oxygen scan RBCs in analyzed markers was XX% We to per than increase and measured experienced reduction lower count. shown achieving observed dehydrogenase. during intracellular hypoxia, a lifespan All of and of X included out with administration. There XX oxygen levels by which with on cell decrease XX XX pathophysiology. XXX potential deciliter. the sickle was deformability also with of systemic bilirubin following up disease of greater intravascular concomitant and in dosing disease. maximum reduction the of in reduce sickle hemoglobin patients dense was to reticulocyte of improvement shift sickle point or of decreases a RBC XX number was profile per patients driver the showing a lactate hemoglobin the based deciliter hydration hypoxia, cell Improved with sickle these treated a prior and of was a absolute an observed pathology, RBC improvement following: concentration An of Improved a of cell downstream systemic inflammation, grams with in in was the the increase in as pressures. tolerated with in by Etavopivat of indirect and X.X and milligrams etavopivat well looked cell coagulation to hemolysis, hemoglobin the was safety a with coagulation, decreased patients key sickle gram and cells. VOCs increase consistent demonstrated

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analysis our totaled and it aforementioned disease the cell the are months and etavopivat we into sickle an Phase enrollment observed properties the in to conducted was consistent interesting and of the pleased measures patients compared gaining etavopivat our results of resulting areas, rates in other the ongoing and into expansion VOCs a phase trial There RBC treatment of also annualized provide period, very which including support diseases. reported with exposure. of patient VOC myelodysplastic an disease, the health. prior Health. PK/PD transfusion-dependent We XX% the strongly RBC of importance over of the during Hibiscus rationale significant years to ongoing the context The pulmonary thalassemia, VOC Overall, and observed syndrome a benefits of planned hospitalization, insights we study results, cell rate in X/X and for in prior we rate sickle XX the three X in reduction finding

mutant IDHX acute leukemia myeloid with or or in olutasidenib, evaluated AML. refractory to being relapsed our patients turning Now inhibitor

ASCO not response hematologic group in best new of plus who composite were with presented December. had primary for disease for the and their Following patients recovery a a yet candidates Phase a more at June, from or therapy plus CR/CRh with were first-line of for enrolled are or last remission of rate. and based ASH azacitidine candidates AML waited of And azacitidine trial as XX%. had therapy. we complete results received [ph] partial Meeting status on Annual single olutasidenib rate remission a treatment a endpoint complete The CR/CRh the positive the into combination presentation Patients cohorts Meeting Annual their the prior results at registrational the X

enrolled had findings an to groups for The basis candidates prior potential from update believe or these or going the inhibitor other olutasidenib range durable who program Dave, The patients who who are an IDHX as combination AML were therapies. hypomethylating relapsed/refractory groups rates FT-XXXX provide of in from agent achieved that, in CR/CRh XX%. the to support to XX% the prior patients a I’m olutasidenib. these not call of with have cancer. With prostate turn over the response for now therapy on We will

Dave Cook

is few we broad inhibitor, able mechanisms development of next to of be utility in FT-XXXX, discussing to metastatic signaling Because the minutes resistance domain, CBP/pXXX which AR address AR prostate Thanks, care the standard spend modulates N-terminal Pat. the believe that FT-XXXX our I’m via castrate-resistant CBP/pXXX for going range of may the limited inhibitors. treatment cancer. a of

performed week one in with predefined expressing there up last encouraging is castrate-resistant a cycle, also and CBP/pXXX dose to least showing safety are abiraterone and utilizes of on were the with potential of prostate presented In eight both chemotherapy. splice C-terminal cancer a XX enrolling are with safety variant, given XX receiving dose who We in instances, many pretreated, criteria. hormone heavily no for of and trial which and a failed which results have design, line adaptive consistent triple escalation tumors based year or AR for in in open-label AR-VX treatments binding on, addition, the target Initial X metastatic is trial one starting milligrams on therapy an therapeutic The lacks of biologic off three-week men patients profile domain and the the at typically pathway. one and and Phase the enzalutamide October, at tolerability inhibition FT-XXXX. a effects approved began meeting an

XXX-milligram efficacious based the drug Importantly, that predictive modeling on dose approached preclinical with achieved data. the concentrations dose

was no stable medically by by weeks. a in disease dose than treatment highest This two XX acetylation, treatment XX% for but lower is greater of which the reduction skin grade in dose then X events experienced tumor, In progressing biopsies emergence disease the were XX to enrollment, was His One the leading XXX-milligram of one trial of was Grade at evaluable discontinuation. than to the surrogate weeks of marker and declined addition, patient was managed a which greater prostate-specific which marker reduced. a hyperglycemia patient or this cohort confirmed demonstrated All pathway. in histone first inhibition as who of the and the was events antigen with standard progression prior at XX% and nodal level, classified radiography. FT-XXXX

the providing since and middle encouraged escalation results forward by that, the are the mutational trial We has results initial Financial over will steps to now our results status Future of respect trial potential therapy to updated turn and We with will Todd. this of October patients. to look With from of call in the update. dose these Chief trial inform Officer, continued next combinations, I lines year. the toward our

Todd Shegog

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

as was and loss million year and year our and increased XX, operations. for million XX, programs for quarter and million Our employee year The equity-based ended The XXXX XXXX. the $XX.X to compensation. to million equity-based quarter million The $X.X primarily and fees and were expenses was and for compared net to administrative the well December $XX.X R&D and compensation, General as $XX.X development of $XXX.X December XXXX. was year by the preclinical and $XX.X of staffing manufacturing driven and $XX.X for support and which attributable to million activities, net December million quarter costs December and loss million XX, compared XX, million professional $XX.X and insurance. to the spending $XX.X ended attributed and and quarter development a net XXXX the million December staffing expenses $XXX.X XX, for and quarter $XX.X quarter development loss ended increase year $XX.X December Research hiring XX, clinical compares for to were the of million our and and was primarily year preclinical ended programs, XXXX. our increased in costs XXXX ended clinical and support ended million increase

million quarter million Overall, Our to I’d with questions. XXXX. to continue compared balance and to capital as support the now expenses cash, was position to working funding we can $XXX.X of requirements at of Cash and equivalents thank and XXXX. third very like in cash a we marketable through use year-end financial our reflects take be operations. strong XXXX $XXX.X you, December XX, operating securities

Operator

Instructions] from [Operator Credit Fauth question Suisse. first Our comes with Tiago

Your open. line is

Tiago Fauth

my taking for question. Thanks

have on additional wanted path So regulatory this on potential hemoglobin on correlates I evidence increasing the recent detail the you forward, discussions more So clinical that it to to some endpoint. FDA get potential we’ve approval, like discussed the with of past with a relevant would right? sounds and provide in

lines just review. difference what months accelerated response on final look approval the XX hemoglobin curious I’m you be a like. between in few a could of regulatory step of the weeks, endpoint back, a at taking time XX last or that then the additional VOC And perhaps potential based would So what have

between nine- but are we there? So our a about estimate is the potentially, difference missing to XX-month something two options

Frank Lee

morning. Hi, Thanks question. for Tiago. Good the

So me here our a and which to Phase has is the accelerated traditional ability Hibiscus is which that take the trial, X/X important is note step study also included to our path. What’s back. let pursue the always

so point. we’ve the that we And specifically we’ve able closely as unique to this clinically is that is hemoglobin required. meaningful because a working with end to sure correlate that we’re to mentioned that FDA being provide before, make action, response And demonstrate can mechanism to able of a the data been very PKR,

mechanistic we And which own on data our year. doing ASH of our the of what well we data, at presentation clinical which shared end so epidemiologic at last doing, as plan data, are we collecting data, what is as much –

generating mechanism in we’re that information thing very unique the this the PKR so that’s fact, is the different. And is, overall And plan. and key here because

point. important an that’s So

with to in the the say, approval approval to pursue can extent earlier traditional Second, accelerated that lines, than would speaking, that broadly a an alignment time I’d we mean likely respect we’re you year about with path.

Tiago Fauth

so it. Thank much. Got you Perfect.

Frank Lee

Tiago,. the Okay. Thanks for question,

Operator

Young Cantor comes Fitzgerald. next Alethia Our with from question

Your open. line is

Alethia Young

more from Hey get do that commercial furthering guys. you on Tiago’s Thanks the progress and can are you VOCs nonetheless? have will talk the the a evidence congrats bit so maybe think detail, far just like the how the cancer bridge think like just a upcoming two to want there question me. on hemoglobin, bit missions a VOCs of see setting, more do data? you with to frame for sets gating as – Thanks. just up? what taking do what the And can we And little far. then on that? as the as say you prostate be success expect to factors you should able I Or may my for are for you kind approved the question. without One, out guess program, And you that And able read kind of little data? how you let’s

Frank Lee

for Alethia. question, Thanks the

approval isn’t optimal we’d VOCs. of Certainly, the later. to a what of as meaningful get let’s hemoglobin the with launching year clinically as be approval versus, First, launching accelerated might be with a on say, path say, said, only speaking. year That question the and, like time, both that roughly launching a extent other like would endpoints that can ahead hemoglobin that and traditional let’s we look

results think depends data the so on trade-off a the And we in unblind at and I we what there’s as IAX. see there just

trade-offs depends. launching really of set with, think your not launching complete with it the are there a data early point, to later let’s a But complete think I data say, the versus set. So year I

data. the what cancer the expect, midyear year. to update what an respect eventually triple meeting program, So presented it on we all last at to roughly just will prostate to the is With depend

that or early the would a XX year, longer of recruit period patients So see I of And and the more to next for followed year, data towards we’re time. complete we patients total. in wouldn’t end set until expect this aiming enroll

and strong progressing nicely. So the demand it’s clinical for trial, have very we continue to actually

midyear. dose are reasonable update and We have escalating, should we a so

Alethia Young

you. Great. Thank

Operator

next Our with comes from question Jefferies. Maury Raycroft

is line open. Your

Maury Raycroft

prostate and good for morning, my XXXX. off cancer Hi, I’ll with questions. taking start thanks for

to more on going your and you status options wondering can midyear know talk how mutation just factor on to And thinking wanted you you’ve Just little the I also, latest if can submitted into a point. then say that’s ASCO at combo an if abstract if to this and bit update.

Frank Lee

why maybe don’t Dave, XXXX? So you about talk

Dave Cook

combo continuing depending case we’re monotherapy I options, evaluating and Sure. the for a to evaluate the Thanks, also at clearly to a Phase of that X, data as setting think possibilities see. Maury. Relative we early multiple combos in to on looking be there’s made but

looking of at options. broad range So the we’re

PSA the the of about done as Regarding doing we’ll and well both be are expression that in in mutation past, fairly mutation AR-VX data analysis one had as as status, genetic have patient we remind the enzalutamide AR at first we with had AR an cohort get, that looking transparent we variant. you associated response I’ll actually resistance. And the our a who

So continue out. we’ll set to and report it build that comes data the as data

Frank Lee

And an of comment about your once question that is don’t on submission to abstracts, accepted accepted. or presentation Maury, that. comment is on typically abstract we We’ll

now, on abstracts. right of sort submissions any any commenting on not So we’re

Maury Raycroft

Okay.

question. Okay. maybe a just Thanks. And quick

You probably of say with too COVID can’t recently. just the but impact much,

comment is provide in transfusion-dependent going if beta-thal, for study more And Just and on one the any disease how as the can granularity. wondering for well, Phase can you X enrollment you that sickle enrollment status cell also for if study Hibiscus.

Frank Lee

well as for early to year. of this the with end and IAX both Thanks our Maury. Hibiscus very of and that's at respect as towards can sites, mean, for we transfusion-dependent that said for you guidance, that interim thalassemia trial with before, question. the I abroad. It's important end And one. here the And year. on is this I closely And have very, also the working which to we've what the an results Yes, is analysis-X maintain the been track tell we've

We has to So time. much patients the sites very, The as been as we're as possible. difficult earlier, is mentioned as situation. as really in much that possible, been no improving making It working That help said, we've guidance. sure it, help team a would change trying sites. very say, do over I closely the see I the with

I crossed And But both trials. that we're how can we so before respect of those with that confirm guidance now, trend. on again the that fingers progressing right we continue provided see to to

Maury Raycroft

Got it.

questions. Okay, thanks for taking my

Operator

Our question comes Mark Oppenheimer. next with from Breidenbach

Your line is open.

Mark Breidenbach

for Hey, the question. taking good thanks and morning

up expecting It And expansion sounds understanding we on dose like Just dose shouldn't shouldn't recommended cohorts I'm a a be FT-XXXX. assume announced later if is this XXXX to to also more be X following to of it correctly? be initiated Phase we expect mid-year correct year? Is that goal?

Dave Cook

we but to to team midyear, relative we'll but at an The that's RPXD So end the planning of right one investments of really year. cohort, for drug for risk announce actively supply. an the early makes that expect make don't time, the the objective that some at expansion is and

company making those And matures. got for as so timing the has investments the data planned a

should gap X expansion. dose we Phase have and So – Phase we between a expect end no X of the

Mark Breidenbach

of statistical Phase remind significance? maybe X? the And just endpoint for Can component maybe chance Hibiscus to VOC protocol that for any the Phase of based with the us magnitude Is there enough. Pat. you're go after signal the size Thanks. seeing in resizing the Okay. Fair X allows you one for altering on

Patrick Kelly

take these on opportunity The is there's Thanks, Mark. FDA change conversations to but if the set, with can Yes. protocol fairly learnings. based

that will that. We blinded is analysis. But do this remember

follow than So gets for design in difficult unblinded. be current the will as do it us data it to other anything the

Mark Breidenbach

the Okay. question. Understood. for thanks right, All taking

Patrick Kelly

Thanks Mark.

Operator

next question with Andrew from Our SVB. Berens comes Instructions] [Operator

open. is line Your

Andrew Berens

on question is my olutasidenib. Hi

in guys the I divest You if are forward, is the plan seems, moving was the regulatory it. wondering to assets still process. it

could Servier-Agios corollary, And not considering really forward you the then that good that alone? should sickle how Patient Or analog? and the So it think the about what comparison IDH Officer. time the deal probably cell to good Is is apples-to-apples program the with a as of like, to we a going this announced that ability the look Chief you're deal program? hiring more for monetize

Frank Lee

but caught questions. little I your there, me up Andy, I you're breaking bit on think a

So on we our changed, forging strategy has the first strategy so NDA. to partner remain olutasidenib, we're not committed and the partner

number kind that's think to, to different of let's deals. deal, Servier comps olutasidenib say, the respect relative are and I So one. very With these

recall, As other a only addition involved it the Servier people. of pipeline not the array molecules you in TIBSOVO, broad might deal also to infrastructure involved, and but involving

molecule. That so is deal. very mean, different kind differentiated is a this said, I this a And of a

If at does on duration of the molecule, CR/CRh this is that months to the believe XX seen, have best-in-class potential look an the be we for it that response impressive you we've responders. based which

is speaking. reimbursement, and care sure voice and the So champion do about that delighted we for say to investigator access, respect a for board. patients that patients. Ify that leader patient's answers the Officer, Patient to funding And question we're have her hopefully, comps. bring that into primary And and mandate champion let broadly just Chief remarkable the everything to clinician we me make finally, absolutely to your here Dr. with on internally also She's help

this other so we’re sickle involved. patients includes the And includes It therapeutic areas and that cell patients.

that been weeks, short with this, board in reporting really the and position your few way here office. into she's the So CEO's I'm leading question. to like the many on a she's And fact hopefully, proud ways, answers made. we're that I'm a regard of directly already seeing just impact the that

Andrew Berens

Great. the does Frank. Well, answer question. Thanks that

Frank Lee

Andy. Thanks

Operator

Frank There to the questions at like for I'd further closing call time. any are back no over to Lee this remarks. turn

Frank Lee

like the taking to we'd call. thank today's for time to everyone in participate Well,

thank with for was the people and and we As to Forma. employees more our their to purpose have accomplishments in diseases XXXX, cancers. even lives of year living and of hematologic like And substantial rare outlined In contributions in pursuit XXXX today, in of plans I'd do we to significant progress our closing, XXXX. patients, a for investigators transform the

And like again, concludes so thank you today's Have and to a say great this day. I'd call.

Operator

program. the This concludes

disconnect. now may You

Forma Therapeutics (FMTX) 1 Mar 222021 Q4 Earnings call transcript