FMTX - Earnings call transcript Q2 2021 | Forma Therapeutics Holdings Inc

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Operator

Welcome to the Forma Therapeutics Second 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, August 13, 2021. I would now like to turn the conference over to Mario Corso. ahead. go Please

Mario Corso

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

Frank Lee

call. everyone. you, Thank for us Mario, good and on joining today's you morning Thank

have proud marked we The lives time, of a patients the while recognizing one living public all with that second left that mission I'm improve to do accomplished and work of hematologic Forma's on our cancers. anniversary company, same diseases quarter and as year at extremely to we've much rare the

Before high achievements. I'd turning Dave review on provide Pat for some pipeline, detailed to of our thoughts our second and call like more level the over to quarter

now specifically, action activator in complex VOC's. meeting and is PKR that to profile approved the this disease. of sickle etavopivat, improve highly etavopivat and you June that as X VOC's, and our believe as cell red modify goal hemoglobin this etavopivat vaso-occlusive sickle sustained and such in patients the multimodal lifespan potential hemoglobin able show as of a or evidence and presented cell the improvement growing and data support All a to provide metabolic health by all blood Phase course stomach daily that call results markers. new measured nearly as disease differentiated and mechanism be once the together, both the multi-factorial may EHA in More the program, FT-XXXX. development treatment in cell lead of at formally our First, outcomes, increase We clinical important improve to etavopivat in can first have etavopivat crisis these results

advance a sickle trial community cell to also say proud talented the partnering are Hibiscus that all living we're cell X/X with in patients the by As access very we people closely in care. lives cell with ongoing sickle Study, Phase we've of to of assembled improve our and I'm pivotal sickle patient who group disease. And a make difference

thalassemia where X a cell populations patients. first forward, Looking and the cell plan study sickle blood and trial in health evaluating of the to lifespan etavopivat year half start next in improving we pediatric trial Furthermore, red benefit this we're other Phase later year. to

has Turning the current oral to has not earlier a cancer. of castration men we in prostate year of began resistant cancer program, a CPB/pXXX trial on standard men enrolling prostate this There's successful. cancer whom metastatic X while for chemotherapy our either FT-XXXX treatment population care, been with and/or whose progressed anti-androgen inhibitor Phase of

a AML, in patients therapies. are significant. FT-XXXX in address is very results, pathway, very and program. the it's submission. need response presented novel will shortly on splice rate, driven these of unmet profile compound, for particular variants to range an And that the a so drug a CPB/pXXX interested cancers. AR-vX development respect no olutasidenib, results on inhibitor, broad update of Dave EHA application And to competitive we're our we're potential survival. provide regulatory AR for ASCO So terms preparing for is registrational in With at approved refractory new based of our third with the the development a and and there duration believe which we IDHX relapsed response,

the to oncology John's very and team. through Chemistry Manufacturing Control, to our I'm new hematology, and Officer him Bishop, welcome pleased CMC quality CMC-related experience addition, on and John John in executive development excited early Technology to Forma's extensive board. functions, lead background in pipeline will and Chief includes we're very encompassing have In commercial.

navigate of review the made quarter rare the patients patients, I'll by depth for lives in the workers, of healthcare us the to help employees investigators, turning turn they as with etavopivat olutasidenib, transform hematologic once to COVID-XX by cancers. and the this posed challenges diseases call pandemic, to now Before like and living more over and contributions call pursue recognize Pat the our I'd purpose over and again to Pat. our

Pat Kelly

Thank damage lead sickle has the deoxygenated multiple RBCs were you, the membrane characterize etavopivat through The then measured I'm ATP the morning the cell repair disease. sickle potential X-DPG an increase to everyone. would reduce clinical effects which and deformability. the markers cell of was scientific is encouraged data Etavopivat increase once good Phase hemolysis multimodal in polymerization, as Frank, the X-DPG RBC hemoglobin rigid June. health mechanism red are on development, in and improves designed characterize sickle to that's the and disease, to outline cell by X with our also thereby membrane during and sickle our etavopivat etavopivat can pleased the beginning distinct which hydration, blood PKR debilitating sickling. daily that etavopivat the in Meeting S, believe associated decreases effects cell a an numerous of activator, rigorous action. have both to membrane X, program hemolysis highly that vaso-occlusive significantly the structures has that decreased RBC the the caused the the a decreased the inflammation sickle delighted sickling binding chronic presented We a by improve been events selective we allows lifespan. RBC and by updated reduce is to cell provide risk is olutasidenib X, and presented our We've sought the ultimately clinical the hemoglobin We Together, improves hypercoagulability and to reducing and with of cell This etavopivat mechanism formed that generate may in improvement of improving function daily to disease. elucidate may conferences. sickle repair multimodal to important at health. program on support oxygen the ATP and cell through anemia cellular vaso-occlusive the reduce and effects goal the cycles and direct development EHA by and ultimately These From on dosing the that comprehensive to sickle results S. very events data of sickle update disease the recently RBC anemia the with of that

weeks key expansion extension and label or dose a Sustained In the of hemoglobin following up multiple weeks terms experienced two greater. observed. open-label of increase out far, administered the to of our or up Phase were XX levels X data X X greater results achieved weeks. thus open for the XX from g/dL initial were to from etavopivat patients XX for in in etavopivat XX increases of hemoglobin that treated XX% cohorts for an administrating results that out patients or the observed And two than for sustained g/dL XX% of data weeks. X increase show that ascending was X

point with increased in oxygenation weeks and from deformability. had cells a sickling pre-dosing the level for Red etavopivatfor improvements and to the improved We observed patients in cell shift the blood when RBC of the also sickle with treated significant oxygen X formability compared affinity functions.

normalizing results health, a the systemic in etavopivat. marked the counts reduction of improvements observed treatment approaching compared the some with reticulocyte inflammation of dosing, in levels coagulation, improvements a cell and demonstrated and in biomarkers majority by levels. indirect end to up markers systemic these the decrease there and red be from baseline of just as can XXX% metabolic LDH indicated to patients Reduction X of with also with saw daily in also to weeks receiving markers dosing inflammation weeks initial in hypercoagulability. significant in were chronic With patients. We and of of blood levels normal in The addition treatment. their showed in patients to The related some of XX hemolysis of patients bilirubin reduction that markers patients etavopivat

to even trials, profile website. today poster at with be well and presented have Study. during found cell safety in could our more disease. a information it pediatric expect a updated etavopivat in the consistent summarized the extension Finally, patients milligrams XX sickle dose of of open this for results to was first with from at that daily, to sickle I had and cell with detailed half EHA, with a XXX our on the of dosed are we be patients you underlying key trial, disease. end on is this begin to Later present and will the up schedule, XX available in being doses the scientific conference, XXX% track this And was daily thalassemia milligrams label maximum With evaluated of currently year the to for to plan for enrollment respect in which XXX year, up Hibiscus weeks. which we the tolerated prior XXXX dose results etavopivat

endpoint with rate as efficacy that or olutasidenib, or XX.X%, available or inhibitor met a survival XCRh, XX-day the With the an reached or successfully survival the myeloid a entry. AML of AML. were month filing. population was a we overall The Phase XX.X analysis months. of the fourth XX%. our and follows. the received in last require remission with for our remission least six cancer. prior ASCO at now EHA evaluated the Moreover, XX XXX% update a patients having for XX% or transfusion olutasidenib and application majority turning twice primary than for duration of In of response. cell and durable has milligrams a an among relapsed independence patients data who patients the was an work complete were call will going year. endpoint response at well red being people or greater for June. a The were overall mutant tolerated a XXX refractory to months consistent These Now, in interim a at patients analysis new leukemia and achieved quarter with The not partial X complete for continues IDHX of the was study trial. the the refractory the comprised or provide Annual with At median primary of with turn The The on relapsed year, of patients patients remission pretreated registrational preparing transfusions data last primary complete months, hematologic of patients meetings require presented in who overall non-CR to of recovery was the key median for of to platelet with regulatory the interim late-stage CRh, who the all XXX transfusion in a Also rate at both with acute our over announced XX to complete with a was points CR CR treatment The complete drug treated. achieved baseline, who transfusion-dependent estimate was responders been that, CRh or entry, for prostate XX.X disease survival who FT-XXXX heavily on months olutasidenib adverse events survival present, was those at median study blood I'm NDA olutasidenib population. with at day Dave,

Dave Cook

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

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

These information. FT-XXXX men metastatic X instances cancer. in castrate to in prostate this the The FT-XXXX to potential and starting disease AR well and presentation of Xth that one and that as enzalutamide, believe year quarter announce as small lines to Molecular presented Circulating tumors, has the both XX taking pretreated the therapy radiographic assessment patients, on have cycle a we of higher as up trial genetic pleased many doses, design, of primarily include phase, Conference open from adaptive utilizes Targets such on including an the line a AACR/NCI/EORTC was in failed and PK/PD safety International dose levels breast based heavily cells enrolling in will AR-vX of at therapy, expression an resistant three began of week encompassing Results Phase trial cancer on, typically tumor one are of with been safety at upon to titration and are XXth. accepted profiled negative and other October number will prostate markers include of predefined experiencing prior as We Cancer titration tolerability week or with and place receiving criteria. tolerability has cancer. Additionally, one data least tumor burden. for today and as off dose XX-milligram for abstract measurements This use triple and and trial of to Therapeutics, earlier conference the chemotherapy label of six a abiraterone and Virtual first resistance. at we're Clinical progression. technically many also with be dependent will men PSA

turn study clinical preliminary results including response. genetic the XXXX, this underlying therapy remain development, call positive We rates of in results I forward Chief assess are novel response in to Although, Financial responders. from anticipated and in trial action the well population to preclinical Todd. characteristics to unmet mechanism as this Officer, data. More some a to the clarify our as sufficient over our of look will steps on for compounds high given and duration may comprehensive men, now from end next of tumor

Todd Shegog

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

the net increase of The support was clinical the XXXX. June with Our for ending XX, our sickle spending million, administrative a expenses increase ended trials staff and as and X loss costs for and X as quarter development quarter executive XX, SCD which XX, net for patients the $XX.X hiring for compensation, ended fees to of loss quarter $XX.X June XX, XXXX was stock-based XXXX, primarily by start-up Research for ended increased compares expenses quarter increases cell driven the compared was increase million in to hiring, June XXXX, million programs staff equity-based development June as was net to operations. and were $XX.X etavopivat insurance. ended Phase to the $XX.X for increase preclinical quarter June million as well XXXX. primarily XX, and thalassemia and quarter X, ongoing employee the compensation. professional ended $XX.X the to million June the The and our million for were in General XX, support compared $X.X XXXX. and attributable trial, development, The well attributable Phase for loss

Our XX, $XXX.X can the use Cash balance to quarter requirements capital the position as now financial continue securities in XXXX, with XXXX. at very reflects was million questions. of of funding support take on cash, the second Overall, be operating marketable a third working and June through to XXXX. expenses strong cash million we in to yearend quarter operations. equivalence $XXX.X Gigi, compared and we

Operator

the [Operator Nealon Fitzgerald. Instructions] of line from comes Our from first Emma Cantor question

open. now is line Your

Emma Nealon

who patients X question. who the including rationale chronic taking excluding patients receiving transfusions curious for is thals not receiving and just transfusion? the through Phase then are sickle go thal cell are for In the guess, Thanks study, I

Frank Lee

question. for Thanks the

Pat. this turn me over to Let

Pat Kelly

thalassemia a initiating well thalassemia, cohort chronic both well. as cell patients and includes XXX are on pilot Yes, of so as the we trial, as transfusion-dependent sickle trial non-transfusion that dependent transfusions the

Emma Nealon

it. Got

versus just the And Okay. Hibiscus to what trying looking what then sickle cell cohort, with at study? and you're learn you're

Pat Kelly

of those look So, And that patients. non-transfusion the as thalassemia well transfusions, hemoglobin at as the burden we'll the dependent as pre-transfusion about in responses those at look on in as the patients. transfusion impact chronic endpoints receiving well populations, patients dependent in the transfusion reducing

Operator

Thank Okay. you.

from of from line Our Credit Fauth comes question Tiago next the Suisse.

now is line open. Your

Tiago Fauth

you for my taking Thank question.

on one, XXXX. So, follow-up

patients. correctly, across to assuming not data I'm probably again, get for So set we're the expectations the biomarker October going to just sufficient update, across,

a And from perspective. all you're the October, just So, at is what mechanism understand efficacy given the a regardless disrupt a how are next trying data that approach? try to an the looking trial certain the going is But of coming day Thank given a that want some then clarify novelty design? for looking of to generally Again, what just you. case. year, level interpret perhaps we're in of really action that I'm for? of indicative data just response to to you

Frank Lee

Tiago. question, for Thanks the

level high turn and comment. me let and further over a to for thought Just it Pat Dave

before, on to PK/PD guided later the results sometime year. And next this safety we've full we're a As mid deliver be results, some for will result final meeting the track year. as triple and

broad the want expectation. endpoints, that's I you. some sort But it other the of have we over So, to on trial to And may turn certainly, goes, depending how Dave,

Dave Cook

Tiago. hi, Sure,

have therapeutic a PSA dose, patient but XX-day the be remember a that a range. on defined, And to is of dose will we has be so in this correct, been treatment order number to You're -- we only it's the be be limited way at that. a for expect XX-days therapeutic assess that treated not in year to response that response at PSA patients it's will

sort set that robust middle year much we data of timeframe. we'll more So, have next think a in of

early looking we very at looking typical we so response, addition these PSA that's radiographic two correlate which is In will to patients, the be a can those. at and in of at looked response, parameter really

Operator

Thank you.

the Our line through next Jefferies. Raycroft question from comes Maury

line now open. Your is

Maury Raycroft

questions. Hi, good morning, everyone, my and thanks taking for

can what enough is RBC EHA production. to robust ASH that, can But functional point sickle and for update you there for what hemoglobin looking get health one First expectations help learn increase your improve update at wondering, that? will on, it we show more be etavo, If be we're if able set about just VOC's. some the to be to perspective and should or on at overall

Frank Lee

for Thanks question. Maury, good morning. the

at presented regimen. endpoints a at that we've June. the now high have Just Basically, more look with level, albeit you at just present completed at ASH, what in what dosing we're XX-week today if those recently patients to it's, planning EHA basically

to that's So, what expect.

you we So VOC's, the when the to at we XX-week think look presented, you that are data that And about say to there little with won't we want types the VOC patients. take full would But with for more markers course have the EHA just at would in I with meantime, Hibiscus until therapy we're looking And conduct might data some, be definitively of a that. more trial. bit VOC. the that respect associated about that talk and certainly of a I data the may Dave,

Dave Cook

Sure. Hi, Maury.

inflammatory that, VOC into sickling, coagulation So represented know site and vascular translates complex responses. starts we process damage the but with the things at that of is like

so, innate actually for of cytokines. looking study a the which activation quite the at patients. And typically at carefully activated baseline of at the We're is pathway, coagulation number looking these actually factors, immune is

other the reduction And looking systemic reduce reticulocyte drive. instance, activation. So, the biomarkers, more ability the we're for to in actually then, at that some

one kinds see have precursors reduction VOC's where think we challenging drug benefit difference we red going [indiscernible] will dependability a that's activation the VOC very sample in all these to would the immune study. confidence we that experience and point absence of build the now small approved precursors cell and open-label you're blinded of trial. patients in study, there well for are for to look of is a VOC's. if that and systemic strong I a I coagulation in of at, will Hibiscus why those placebo a two study for say, still that of positively, I'll very So, seeing think that's it's have instance, that reduces that Hibiscus that, VOC's VOC's, that the out biomarkers just you a and we're with But

Maury Raycroft

And then, just all perspective. to other it. mentioned potential That's indications. really you during Got to remarks check the on, prepared in etavo also wanted the helpful explore

you talk if that can wondering, bit strategy? there when and more a about can the learn just so, little more plan And we about

Frank Lee

hard already that at the ones looking the of of about program Yes. we've and the work, possibility talked P Maury, we're sickle at is, other Outside some [VAL] the indications and populations. cell.

We populations. other a until indications be end towards number that to are in considering We of share year. of likely the ready won't the

the timeline that So, we're operating under. that's

Maury Raycroft

Last it. me. for question Got

Just for the triple point? meeting updates. Is to baseline into there anything want perspective else AR-vX just not you whether patients can that say at clarify, are on baseline or characteristics? And have you'll at if

Frank Lee

Sure. Dave, speak you Pat, you to to want or do that? to want

Pat Kelly

only they is lines Sure. have a chemotherapy. Obviously, and may say. population, line therapy typically one have had to just I'll in multiple they while of heavily pretreated they've failed fact have this had

doing circulating -- analysis. cell and We tumor are ctDNA

we'll data; the batched. AR-vX both So, have status however, and data mutational is that

we batch don't patient, but you each instance data the it. for if with So get

timing patient be that on, amount batch will So, end of depend and in. they the one of would what on some the data end available in sense, up study

phase. worth a should being but escalation dose -- share that as no early as So, should we're comprehensive by the be we we be I in it's this'll that's really perspective always think you do, data. why what still can means since We'll thinking keeping

Operator

comes Breidenbach question the of Mark line from Oppenheimer. next Our from

now Your line open. is

Mark Breidenbach

guys. good on morning, Congrats the Hey, progress.

impact for performance in wondering your Tibsovo diagnosed I'm a randomized trial discussions has setting of in Just newly early a one in positive And olutasidenib? Servier’s partnering it's AGILE AML any setting? if if wondering, inspired the on of plans trial similar had success

Frank Lee

the in That talked are we remarkable. are We're Hey, olutasidenib pretty very partnering in before about strategy as presented about data excited we've discussions. that Mark. we've Good about morning. said, the program to actually committed we're before talked and partner

in so we're And interest and the I on can can't partnership and entail. what will encouraged what very is year the I program say comment also by end. But those the the

Mark Breidenbach

us for follow-up but give Okay. terms pediatric the And what can just endpoints that? pediatric expect transcranial little cell program, trial like in sense can flow if a like like look might a size? maybe sickle things of specific sickle quick cell Doppler be might you the velocity things And on efficacy any early, we

Frank Lee

Yes.

Let a definitive. regulatory me have the discussions say at can you nothing But just some initial thoughts. so certainly, still we of share authorities, in, level, with thoughts. some Pat, high may course, we're

Pat Kelly

Yes.

of at part as at this looking is look as mentioned. The all study, the to the efficacy we're this and setting. that heart a Frank pharmacology, think safety or of clinical in pharmacodynamics exploration additional in intent are opportunities young endpoints discussion careful the the of I patients. But benefits etavopivat

Operator

Thank you.

of next Garner comes Robin from from the Our line question Craig-Hallum.

now is Your line open.

Robin Garner

guidance Congratulations for have in on your I the etavo. quarter. a question you on

Looking and differences could upcoming pediatric studies underlying differ we to at response populations hemoglobin patients, the how in the etavo versus in thalassemia sickle these given the expect adult with cell disease?

Frank Lee

you one? this want Hey Robin, to Pat, for the question. take thanks

Pat Kelly

under unstable etavopivat you're asking etavo the such patients of sickle seeing should red cell us activity these it's patients red we're sickle in thalassemia as in as Mechanistically, patients that the active younger to think characterize activity I with patient of activity the mechanism questions all in the populations. well patients hemoglobin. with particular part confidence this Yes, the cells and that of XX including cells benefit already giving should disease that, be

Robin Garner

Would patients than adults you different expect to see pediatric of an very have who more therapeutics? typically sickle cell in to effect responses

Frank Lee

hard results we've and that. be in improve we'll entire with to a patients see. patient the very across to suspect population. I pleased cell with the It'll on seen We're adult date response robust the hemoglobin generally very sickle

The generally of more morbidity. of done right. healthier you're younger think better have accumulated without standard care I with those therapies patients in of terms

better better will or population. gives to patients we So that confidence that translate responses in us younger equivalent in what adult the see or nearly

Robin Garner

for Okay. question. you Thank my answering

Operator

for Thank I'm Lee turn the showing like back remarks. you. to questions. would At to I this call closing Frank further no over time,

Frank Lee

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

look mission The brought cancer of for FT-XXXX continue the as prostate cell important therapies disorders sickle olutasidenib a as And new our etavo you rare bring on progress our well and second to XXXX sharing and great We in today's programs this in to to Have patients development on with day. the all. more cancers. hematologic year well our as AML. Thank quarter progress call. end to in prior data new lead compound forward truly concludes

Operator

participating. conference This concludes you Thank for call. today's

You may disconnect. now

Forma Therapeutics (FMTX) 13 Aug 212021 Q2 Earnings call transcript