Cyclacel Pharmaceuticals (CYCC) 12 May 202020 Q1 Earnings call transcript

Good afternoon, and welcome to the Cyclacel Pharmaceuticals First Quarter 2020 Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. After today’s call, members of the financial community will have an opportunity to ask questions. [Operator Instructions]. The company will also be accepting a limited number of questions submitted via e-mail to the address, ir@cyclacel.com. Instructions]. [Operator call today’s being is note, recorded. Please

now to Jan would like Cyclacel to over call conference the Medina, turn Pharmaceuticals. I Investor for Relations

call first quarter and joining March XX, results Good you ending business to conference and the everyone, financial discuss for afternoon, highlights XXXX. Cyclacel’s thank today’s for

the like Harbor to call Securities Securities turning made forward-looking XXE Private Before would by call provisions fall that of everyone management Section XXXX to over remind the intended within Exchange as statements Safe the during of I are Act and Reform management, to this of Litigation Act conference amended. XXXX the of

in As website. These among filings forward-looking Forms SEC affect our statements the XX-K. set SEC, that other release, or the XX-Q our and may and our the uncertainties forth press involve company’s things, risks discussed prospects, our filings are which in with include, from and business available those including

forward-looking All as other of information. our and update to any our today, does such judgment of projections not responsibility take and statements represent Cyclacel

be us Development will President Chiao, Executive President Executive Clinical Paul begin by McBarron, Cyclacel’s Dr. financial and will and Affairs. Regulatory Paul of a overview and highlights and quarter our will Q&A President, Officer; Vice are Rombotis, for Finance With Officer; Vice accomplishments with Judy Chief of Chief Operating Spiro Spiro followed and today an and multiple business which strategy XXXX, provide of session. on clinical programs, the first

to Spiro. would At to this time, turn the like over call I

business everyone update our and today quarter Jan, XXXX for you thank us joining you, Thank for call. first

well. webcast all of are we hope safe listening you First that to and our and foremost,

and made from all in disease affect clear nearly emerge creates business have that The months need the last the by continues The sector. solutions it crisis. global science-based to human caused of COVID-XX events uncertainty we novel pandemic few every to activity

the health very our and we At and in and the communities the in protecting which responsibility particular employees, safety patients Cyclacel we we take of live seriously our served work. social

we release, from taken with and our following As our government working mostly have measures protective relevant home. indicated press in orders today's employees

clinical sites clinical supplies are specific during of closely FDA the and to trial ensure pandemic. guidance working following are We’re with trials that adequacy

advised more cannot that enrollment. they join continue such studies assume on We or and circumstances clinical patients second and on the with by difficult in been to that patients register have same surge screen for remain investigators remain we time, to as make studies. track At it will a our our

risks increased in environment. Cancer this patients faced

and as requirements. therefore design protocols we visit new and such are schedules subsequent considering we matters research dosing As frequency of translational

of cancer Despite problem to our and these resistance. of rising serving clinical innovative challenges integrity Cyclacel's pipeline business an are addressing committed of the strategy the is patients mission our build to we maintaining research. cancer

agents of We treatment are and in and effectiveness alone anticancer drugs combination studying ability outcomes. the with improve other our to

We and briefly are pleased fadraciclib. today's advancing our lead on drug to for report plan progress call will a describe continued

will and forma we provide of spring of XXXX. million a $XX.X current the spending estimate raise, that on runway plans end including cash equity pro Based the cash to our equivalents

first review we'll So as known fadraciclib formerly CYCXXX.

in suppression is of act and which of Activity levels. targeting isoforms components and their novel inhibitor E key CDKX pXX against CDKX in CDKX Fadraciclib again a the as X results pathway. of CDK MCLX reduction cyclin

in or patients E as single resistance of in MCLX proteins other a agent combination patients tumors with drugs with of Cyclacel such in is evaluating and or oncoproteins with Cyclin malignancies. cancer Overexpression hematological are evasion. with associated cancer respectively solid amplification Fadraciclib cell as

the is others BCLX over BCL-XL including member as cancer. which mechanisms cancer of expressed the a and MCLX one pro-survival and act BCLX, of for one frequently is family XX protein most genes BSLX,

several gynecological to breast escape cancer in by encoded protein to endometrial/uterine E a cancer ovarian. Addiction and E, the Cyclin cancers CCNE treatment. by cyclin cells over including expressed death the is enables gene

into cell cancer and death. forces therapeutic machinery programmed proteins the to this leading cells Suppressing death. reactivate apoptosis aberrant cell suppress or apoptotic of transcription to Cyclacel strategy such proteins is

to solid MCLX protein Recent We of is discoveries activity suppressing have Fadraciclib as of resulted heavily a in and patients importance blood durable in the market in a peripheral mononuclear of suppression to bring monotherapy on anticancer based race leader tumors. of this race that pretreated believe cells with MCLX medicines. the demonstration in

sparsely in enrolled as X a MCLX weeks. or at infusion a of patients the who escalation four-hour Recommended schedule. XXX-XX study majority RPXD Dose dose the observed patients part We of single XX every enrolled our suppression Phase in Fadraciclib administered using three was one received

with all patients the E who relevant had mechanism cyclin including shrinkage amplification. stable tumor MYC drugs disease to and/or markers achieved molecular Nearly MCLX

and with nine enrolled We further XX every ongoing the part study weeks. more a one have eight dosing two, hour three of one, a patients frequent in infusion two on days of the schedule

fourth has and dose been enrolled patients establish the part in reached level Escalation two to additional RPXD. have

the month previously partial half reported achieved MCLX at Fadraciclib. on response and endometrial confirmed patient As a a cancer PR amplified dose or pretreated heavily level with radiographically fourth after a

is human XX%. After patient study the continuing on dose. after has approximately her This on the to lesions last months shrinkage target restaging nine in same improved

of tumor ovarian E months Another achieved of Fadraciclib patient after amplified was four stable shrinkage cancer with monotherapy. disease XX% cyclin

on MCLX durable in plan of evaluating Fadraciclib driven activity precision we agnostic, clinical further study to cancers extensive medicine of overexpression and on preclinical and clinical in cancers. tissue gynecological a E explore suppression patients with Based various Fadraciclib's cyclin data

microsatellite are instability mismatch parallel cohort a open of X/X label The concept or phase planning Briefly, study behind this design. the approval we study broadly high cancers. repair in follows precedent-setting pembrolizumab

endometrial/uterine receive patients subsequently or is available each cohort enrolling on patient Patients XX ovarian and breast depending The XX sample with therapy initial combination options. monotherapy size will cancer respectively. Fadraciclib

secondary be benchmark be rates. Successful be Details of Objective response against consultation important endpoint. ORR forthcoming Primary performance of will would experts. an be will or Response with after duration response endpoint the trial ORR Rates and would measured

early to expect this delays. study we started pandemic of enrolment it approximately in XXXX Once year one take notwithstanding has

In addition are to of capsule oral formulation. Fadraciclib an intravenous administration we evaluating

and patients the second reach three dose have dose level. We

data PK demonstrated test or exposure program hypothesis against activity to profile or leukemias. malignancies administration hematological PK with BCLX of that closely refractory overlapping we our dose the IV in opens have levels. escalation suppressing MCLX pharmacokinetic predictable anticancer studies In that encouraging the result Initial two a can and relapsed

of MDS We are XXX-XX. for patients CLL safety. study evaluating or or alternative a Reflecting and the with in we patients RPXD AML in rapidly endpoint XXX-XX is XX determination of the XXX-XX, the relapsed relapsed unmet AML Fadraciclib have refractory treatments and combination in enrolled venetoclax refractory and in which need primary

inducing study by The This double a AML the that plays evidence of and and may is of role rationale MCLX suppression hit dominant be venetoclax that protein for beneficial in is Fadraciclib clinical more alone. than either suggests apoptosis. supported suppressing synergy

on a of schedule of escalating and four-hour Fadraciclib a received combination every patients venetoclax once two weeks. doses oral pretreated Heavily infusion

reached total dose have of We combination. where on venetoclax dose Fadraciclib level mg/m² XXX five in XXX patients two mg XXX and approximately to with

doses blast activity Tumor or mechanism. license with previously syndrome follows of patients patients on lower to in of anti-leukemia treated reductions both blood This reported TLS consistent the combination. a peripheral in leukemic related was drugs the reported with

is additional responding BCLX the dosing the lymph associated especially on overexpression. MCLX In an plan by mechanism, more may evaluate to stop schedules. followed to these in the cells relapse CLL, is with Based escape we nodes overexpression and main frequent venetoclax findings leukemia MCLX often feature

the slow lymph achieving thus reflecting XXX-XX the Eradicating far residual in survival an frontline or been enrollment is disease nodes CLL treatment has negativity free CLL after important long and minimal MRD objective. therapy. In relapse

have certain patients to open of Cyclacel will to new advised a we to amendments to and unmet Given Anderson. is medical relapse, enrollment number sites In that order need investigators in as eventually protocol addition an persist large have MD emerging. increase implemented

per Five patients four treated been or squared. milligrams XXX dose after so level meter have far

failed therapy ibrutinib dosed and was They label for as respectively ramp, milligrams two were first weeks The Fadraciclib two well five CAR-T. cycle or also tolerated. and patients per square of post venetoclax which two per XX the every at meter six once and one failed

our their Anderson whereby of was the all assumes Both drugs provide studies costs Anderson and University lymph we for of and cycles after five Center nodes support. the of Texas, Both one MD these sharing with investigational continuing of patients part patient risk MRD-negative MD had combination. and limited are Cancer studies shrinkage on alliance other

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is This enrolled oral dose with has XX safety of effectiveness evaluating study patients venetoclax. sapacitabine an escalation and combination of and

with patience evaluating a investigator sponsor BRCA-mutant Dana trial Farber at AstraZeneca or an cancer. sapacitabine IST Lynparza addition is with of in olaparib, combination Institute In breast enrolling Cancer

Fadraciclib our inhibitor was to polo-like anti-mitotic human dose first kinase evaluating patients escalation program XXX-XX, single we're recruited in or like been discovered Five a in-house. advanced agent with PLKX In our CYCXXX, study. leukemias have which

cancers. we to No where a has be testing dose of volunteering potent and is models selective target virus. and our activity may for far. responded they been CYCXXX selective companies Like in indications that and medicines society's have many inhibitor human toxicities inhibition patients have PLKX by small helpful peer affected biopharma to xenograft molecule corona demonstrated the observed by thus limiting high call

for of evaluate university have inflammation runaway reducing this collaboration potential in COVID-XX lung with in we To seliciclib the end our inhibitors, injury recently to a patients and CDK announced disease. of with Fadraciclib Edinburgh acute the

of ISTs In Cushing's generation and CDK seliciclib Medical our patients rheumatoid Cedar inhibitor University at respectively. Newcastle Center in arthritis Sinai the with first evaluating disease and addition two are

the over from years. the foundations laid quarter next multiple outcomes During two we data the

data upcoming safety executing development in Phase As advancing patients frequent milestones advanced solid clinical cancers. and our Fadraciclib, updated our IV include strategy with and our key we report continue schedule efficacy X programs, dosing with

first from in from of Treat safety studies. in formulation. driven X and Report data and data Fadraciclib initial initial venetoclax Phase X/X relapsed Fadraciclib MDS study medicine refractory X CLL. Report patient precision PK Fadraciclib, Phase oral or study AML Phase

Phase Report in from MDS. investigators. Xb/X sapacitabine breast report CYCXXX from IST reported initial relapse/refractory BRCA cancer venetoclax AML initial study by Phase data Phase leukemias. data mutant in sapacitabine, when Report study X olaparib relapse/refractory status in the metastatic or In first-in-human X

With key through in our milestones the deliver of XXXX resources capital on-hand studies. clinical have to end estimated we the

Paul. quarter to financials. I to turn to our would not the first call like Paul XXXX over review

Spiro. you, Thank

find X.X of press million equivalents financing cash decrease March in The ended in activities used net million December the million net compared used to cash cash was $XX.X I point X million today's XX, totaled to and $X.X of release XX, million in XXXX operating of for $X due quarter of activities. As and primarily XXXX. cash as

million in net net March financing an that end XXXX. raised proceeds as And programs resources of XX, financing equity of April XX.X of fund equity we with company XXXX together The XXXX. the million estimate approximately to from will the $XX.X planned currently cash

were and $X Research as three approximately XX, to compared relating development the the the ended million XXXX, ended $X.X XXXX. increased in the expenses continue progress $X.X XXXX months period months development for to of March Expenses million by clinical three for transcriptional same to Fadraciclib. program regulation March we million our as XX, for

General same compared year. and the for of $X.X XXXX to million previous the March the administrative the the were March million Total million $X.X million period year. expenses for same compared was with three previous for ended months income XXXX the ended three previous XX, period net for months of year the other $X.X to XX, $X.X

to XX, purchase months March related were XXXX. of Thermo development XX, an ended the ended increase research Fisher each the months million The United and XXXX Kingdom is with received Scientific. asset of March $X.X and XXXX primarily $X.X credits tax for for agreement income three three under

the XXXX. XXXX for loss million net XX, for period ended was March compared $X.X same our to in And three-month million $X.X the

financing, shares. the X.X outstanding Following April common equity is stock our million

are we to ready take Operator, now questions.

Jonathan question Capital of first with Aschoff Roth is Instructions] Jonathan? Partners. Our [Operator from line

breast Park And guys. or in by with that eligibility? with if you or combine Could wondering solid something such fadraciclib was CDKX/X And monotherapy good not what increased landscape is let's overexpressing in solid addressable then Thanks. tumors for the given failure after cyclin effort as inhibitor after consider to cancer, failure inhibitor E you tumor afternoon ovarian tumors. drugs cancer like potentially after I in say close platinum might enough? describe fadraciclib the solid the

The clinical for been Jonathan, important the for months. gynecological thank is you question. much evolving, reported your very recent but data in has cancers landscape

Drugs in like of inhibitor question is receptor For the course is therapy. of CDKX/X hormone of example, cancer this positive to regard first care of breast your palbociclib, cancer abemaciclib. together with part which the nearly breast population, is breast three ribociclib cancer, entire standard the hormone quarters and

drugs the to type CDK cyclin inhibitors class ago. study activity two of of of with correlate this ASCOs Pfizer's This in E. or resistance PALOMA-X of shown When amplification over primary was expression X/X palbocilib fail, is for this

know that combination patients is E. and therapy of we who this therapy CDKX/X So and of the the combination this care, of standard will fail vast will cyclin overexpress receive hormonal majority eventually

this is cyclin hormonal a approximately receptor So present literature from E important We amplification. of subset. that will a this third with clearly very estimate positive population citations

I It take may launched remember we're XXXX it. U.S. before in few a see see now that, fadraciclib in years. the we the was starting to but

to on cyclin modeling inhibition marketplace is a amplification patients available therapy than therapy address XX,XXX and the E literally resistance CKDX/X fadraciclib. with based plus important So hormone reducing more very like our to

on comment ovarian this ask go will Judy to Now before population in discuss combinations I terms Judy? I to cancer. of on

Okay.

is our failed try in of patients to think really population hemotherapy combined one they it front line. used with who have I strategy commonly the a So of the

As we also oldest you receptor to therapies. the types one estrogen three know degraders of have that hormonal tamoxifen, basically inhibitors aromatase and we The have surge. then is

combine front line failed is X/X who to therapies. hormonal one those patients the have I our of with think that inhibitor plan into

you, Thank Judy.

a after ovarian possibly either patients and part literally combine recombination inhibitors. days been progress for now deficient even inhibitors, HRD cancer who have new not landscape your the in addressing more We saw Yet Most they So proven, BRCA positive but to that of is activity. PARP patient's high the only of ago tends combination tend suitable a a potentially homologous in extremely and patients of that about not levels about are second just couple possibly subgroup long of what an but are was HRD question who or to also has positive, disease This after is alone and approval flux. with, durability. have PARP testing, BRCA-mutant some year. to of

Avastin patients are In standard with for care the which therapy PARP in have frontline whether who of as be patients to bevacizumab inhibitors cancer on may. new based And HRD or not subgroup clear emerging benefit the of negative, patients a HRD of negative ovarian Avastin data. its that based appears recent entirely maintenance is same

disease But of course to control. PARP and achieve combine inhibitors could one some bevacizumab, Avastin

they never therapy vast E inhibitor experts patients are cyclin who platinum us majority have typically telling the to insensitivity ovarian However amplification. have of PARP that are offered possible because

being this So with present cancer addressing patients XX,XXX as addressable mentioned candidates a suitable population high-grade ovarian estimate And the a XX,XXX PARP inhibitor of regulate patients about total, by E can being with drug share with of in either that platinum is third therapy. I which the serous who will for ovarian cyclin of -- not approximately that not amplification. and/or market type lion disease or of

therapy. in So inhibitor PARP not you are ovarian for might patients possible what continence be setting Judy could answer who particularly for suitable cancer the

this the need have we in field. a think question I to with discussion ovarian further is expert Well, certainly that

that patients platinum consider, they were you initially treat with we know traditionally we sensitive. if platinum As

think settings. combining be sensitivity department planning, a I refractory commonly retreat price was XXX combination of that and looking then at example should agents some and in So or other very one that them that and we the for used with

question. Okay. more Thank I you. one have

program COVID-XX since its on announcement? wondering the what's with been has going XX Just April

and on Jonathan. to that our Thank give audience can you, to collaboration. We update certainly you an

three papers this neutrophils. disease, by from all of to from injury models and effects can are of lung bleomycin inhibitor. pleurisy the XXXX XXXX such with CDK days damage activity immune published injury inflammatory injury showing on of this Neutrophils of They first-generation the starting is are Edinburgh antenna on further this as to anti-inflammatory important neutrophils acute overactive neutrophils activity that in course produce of caused of XXXX appears lung after induced the lung inflammatory there to localized you activated and ranging animal but press activity models effects some be the fibrotic seliciclib an activity one As know ago neutrophils. on in part different research system on family release in subsequent University

inflammatory need to directed called times came often apoptosis problems or massive cytokine they're cascade to be storm. The across cause

In also which xenograft that data cell. regulates decline. Boston attaching of Institute same Cancer Farber X of have studies addition the showing interleukin in a cascade prognostic the set about is found also years seliciclib rate in stromal context bone COVID-XX is seliciclib in the Interleukin time the Again cells hallmark published inflammatory from slowing of rapid that the post-mortem blood. another major that of marrow a course of active myeloma group and myeloma adhesion of Dana is of in of ago in at to the and factor X. many also transcription a when down been to experiments have They models cancer transcription demonstrated patients the

to for So If all a and class so models first the inhibitors has would keen new Edinburgh the of encourage is demonstrate same is that then this them. University whether of see fadraciclib reason I been in they our observations perhaps this apply of property far to CDK inflammation. systemic a certainly tested effect not

of of which a are them under that to would program target Edinburgh COVID probably and other is go what to exploratory we on sources. who to effort possibly study by they is called Assuming UK wide medicine a centres have a the reproducible both which collaborate like a they could funded big confident government auspices University with stop charitable stop

and learn is also more to to and addition we're us keen a inflammation patients about oncology our the drug. our company are expertise This for effort potentially of is win-win extent this helping we'll help although area say in an can an we company not to So very who

guys. very much Thank you

Jonathan. you, Thank

we Li next, question have Ladenburg. a from And with Wangzhi

Your is open. line

taking Thanks hear question. you Hi. for my Could me?

We Vangzhi, hello. can hear

good. Okay,

I So, update. follow

miss dose I higher is question wonder now? It's first fadraciclib escalation. I IV now? agent but what regarding the it, still dose XXX Maybe The are the you is or single level

correct? talking in the Phase you're tumors. that X fadraciclib about Is study So solid

Correct.

Okay.

and the XXX-XX at let part maybe to we next. will testing Over So Judy. is frequent And describe We're you happen this I a Judy XXX to see what study. schedule. to dosing what

the Yes. it. XXX going level. at We're We're above still not milligram

Okay.

will trial? be for So tumor that dose the the level precision

part two be precision the The tumor will trials dosing schedule. using

the will dose? XXX Is be it it dose different is milligram or

about the recommended far Well, it's limiting milligrams once dose that not X We XXX this, be when dose Phase that will toxicity. dose tolerable. so the going But I when we we tolerable. think lowered expand have to or -- trends that we is don't is come XXX, the it it either if level excessive

some required phase patient We in still so sorting have of we out. that dose reductions,

we limiting. dose So have excessive don't

Okay. Got it.

of little COVID-XX? terms still the reporting data the needed late In XXXX a or bit data should timing report, because maybe we of of

Both program X to results. the principal the Cancer Institute oral, I publish we IV with for Farber investigators came been in studies an doing whom the the Dana Phase both our the

had conferences two have with be with physically There somehow but ACR held the to this year. or they held as are soon and Major ASCO. be the We end will of if We those don't know have will with them. discussions meetings. we they oncology virtually, seen

expect we we'll in of data review by XXXX, a setting. have peer So that end Wangzhi, available

to shifting oral formulation. then gears Got And it. the

need How can formulation. looks patient IV the you patients three combination? see the the You wondering pretty think to to that just far, many formulation IV really say, oral dose so how placed have I'm levels. consistently

Okay.

one XX at said, and we as of have dose at first all, flat two you milligrams XXX. So patients; three indeed,

but expect X, the capsule we we that X, with be with little schedule, and So to using oral Phase time still given IV a below this when X. same X an the are we're exactly formulation bit

still Judy is me with about ask her a Let the early development. expectations in oral caveat that

two Well, it's always a formulation. bit between challenging to the predict

good. windows I think go that because lot, may the would looks be be that I are the don't at We we PK the pretty is I a level, close. think favored. think bioavailability is the up go good oral have of to news able up but to And

it. CLL trial. Got the final my Okay. is question on And

two give setting? do the a setting wondering You just saw you competence to thing further CLL bar I response MRD or at do are you negative in the for these now. of what to avenge you ORR

was combination. This But in great still is recommended study primary question. is with we dose are phase we a endpoint this first ever the X and for think escalation I dose did The safety. which this study,

combinations designed I in do the release will think of the for don't combination at efficacy. very chemo being So or immunotherapy doses will the are the previous communications are. period. patients years patients than determine we well two our most that to last We're on with XX% relapse. least because would patients get learning the I think was tend three that still what to But most of anti-CDXX, lower and of inhibitor drug setting frontline as regimens properties BTK press initial at to of them whether party this mentioned they in or CLL survive there before venetoclax based, even based More relapse that

is are a the there study patients to very treat things phase frontline they fail a wait repository therapies patients all for sometimes hard. come one of once therapy. to large then available o fail to we Once relapse

benchmark hard be. to duration of the Wangzhi of this level point right what response as really So as it's at well would response

observed on if to the negativity on to with by which where the venetoclax certainly concomitantly combination did stay node are were on they not We sensitive venetoclax persuaded appears achieve with reduction the be in was to treatment. alone encouraged MRD patients MRD sustained the size even clearly alone, lymph negativity patient the the

in can the ultimately activity, what let consistently on we study and randomized start think yet suitable But suppose duration, projections I a and to level I give alone design drug I of make be would exploratory are those would a call therefore findings. don't at a we where CLL. level

square what in but are more now we we course First per we have giving than tumors, thing is which meter one solid We're much and XXX in consistent to define close. AML. milligrams of think RPXD is at our

XXX far. per around an topping as AML, So we're we're meter square, not milligram too

study by primary So then to get we defining this of endpoint steps. year the be of end and his should able next to start the

Thanks it. answering questions. for lot by Got a

Thank you, Wangzhi.

Our Kumar? of next Capital Brooklyn Kumar Markets. Raja line from question with in

taking Thank questions. you my for

of tradition So and from would your with regard expectation medicine in based to terms approach, expectations and sphere. diagnostic, the there. are company the company diagnostic in terms And of the DOR? genetic development on regulatory obviously office what ORR are population strategies be background what in of strategy the terms what And in in terms of

see We do background and on trial can will pickup like a based going the you ahead forward get approval expect that. based go genetic on How ? we

Kumar, lot pick don't because will and a important on we first for options. they're few enough But of we which yet me then discuss are you to have of and course multiple address strategy and questions not the and issues regulatory addressing data. other thank ready course of let your Judy

at in of and the however diagnostic I strategy. centers large important think differences. least get solid There are next-generation tumors seriously some thinking patients most screened referral diligently the companion NGS via In very sequencing. we tertiary US

to some four cyclin determine it's to don't suitable a classic by PARP in these prior of example the BRCA And and/or or for status three So NGS we doing determine need ago. inhibition MCLX the therefore profiling years patients. possible E for patient assay

seems can how them comfortable and baseline data. protein status, like with we potential Ultimately and cannot a would will needs of the patient easily in ask further testing have short solid a of in follow-on and is be We centralized the area know NGS the is in a state to more in determine would have But and specimens are with certainly particularly amplification we baseline will determining by feasible determine to feel cancer tumors to gynecological move genomic challenging He to if time. evolution Certain of some along to there come and forward. leaps investigators but we'll way, standardized important determine least relatively assessment determine that be that COVID-XX. in a this genomic That I patient's determined to young distinction using at patients status want have of to this advanced that. bounds be of that explore technological done give but the about routinely. quite in by status to

In by terms overall response of courses this cohort. of response could different of benchmark, and rate duration be

We new in learn half decade be of / lot cancer or so. Judy incidents the none breast those endometrial which increasing But and more in survival dialogue, to the last a have uterine its only the cancer landscape cancer you probably a we discussed is subgroups poor compelling on has It's these ovarian evolving and as of to women's little the both cancers mentioned about pretty options, of but appears based that be disease. ongoing. And continue feature has validated to that over mortality are which need ideas as rapidly to by this have bit some good a before. KOL what we be

So very it remains need. big medical unmet

half these in be will our more important define this questions precisely once year with answer able precision better be will give them placed color. of second we'll study then that the are medicine driven to more for and So happen to criteria eligibility

Let me regulatory strategy. ask, about Judy other question on to your comment

thank Well, you.

what I pretty cyclin regulatory good precedent certainly E see identified -- think you right in just be activity the would by I we in by the your FDA single that and we're or amplification then a that I approval have the straightforward talking strategy, that suffice could probably response that I agent of other that's around and that will defined probably consider rates already response if rate need that magnitude XX% we MCL. Well, either population refractory certain range and abilities. about the something think be and which precedent is. When that than higher sufficient mean

study's is after I required for probably approval studies. regular think approval randomized

agent of the have ways toxicities, they comes alone. are actually combination And about together to two are single drugs is two completely chemotherapy questions that is in. active there where And overlapping both this think one to have but therapy. don't One combination

to you or at if -- -- example carbo, cancer cisplatin neurotoxicity platinum, cytopenia know especially have all. from to any if combine a and then certainly, toxicity example, cisplatin would toxicity variant whether yet For is just it's with not with I'm that predominant carboplatin one using myelosuppression choose platinum we for seen CYCXXXX of

Your benchmark were the has active departing MCLX chance to based they're who previously And have departing that chemo and sensitized in respond has second hypothesis for along. is patient course action themselves reducing responded they be along where both cisplatin. to hypothesis actually you to who cisplatin of would because therapies. In certain of patient against on chemo the messiness

of Now that I don't randomized the have any something improve clinic is studies. the do until we in think we that

I hope question. answers this your So

it the clinical does. the question one with to enrollment Yes, trials. more regards And maybe in

You still guys screen on are patients. continue early involve to mentioned and you

And and differences what in from terms some closed. recent? is because states of like you time various of some So it sites, like states up this, line are still for what are opening seeing are

the So the of talk monitoring and bit what what site? the to with made patients are kind in maybe are in on guidance changes little were trial? can you already And being regard seeing FDA kind of differences the a of some you

question you, and guidance first Thank your I'll due came that part the FDA to handle the Julie COVID-XX. Kumar. recently out take of will

our is enrollment, Farber of MD Houston in is. Anderson enrollment course Dana is terms regional where So of locus primary and Boston, of

not surge was but it pegged we're encountering the It in not chemotherapy, of factor. press recently if for year a example it's and in appears our a decline. go Boston point was referral to on Medical Farber patients. Mass yet We know and one the is some many COVID-XX in There be Dana appears of an how General at this at reduction infections. based center the Harvard about epicenter of somewhat chemotherapy will Obviously, It hospitals in that there We less the LA hard Dana was the there Complex article to affected in is the late is primary as new Times the Farber. that for that drug it XX%. reported downward things the pandemic have so in risk that not curve an is issues, slope dramatic seen say in second is

for considered been continue being patients Jersey remains that expect, able They concern. unnecessary Boston control trials. patients so New so I that in prohibition entrance are has course system on it into access. family not and potential they and can is poor short receiving Anderson Seattle, or this treatment the serious for have Houston been terms problem are visits if and York enroll, very spared unaware restrictions New before area and because think few far imposed of relative of anybody have to MD to very and relatively we prognosis. they're no on. has call so entry, screened our a But survival AML but of faced compared studies complete enter on these becomes our of being patients very don't to investigational

far this so we are In new they are our major CLL study, mentioned a area so Washington They region. in DC those as sites of two mid-Atlantic we their this how have Philly on not to both or exposed know input have the respective like metro moment far the enroll of forward, virus so in risks so study move not as they but able to will patients, been continues. this we don't from

And So Europe down you first we the to described. also we U.S. what to are pretty the they will back adding come new handle of the there. They work midst trajectory of in the to to have future the There's can we until how pandemic dialogue have sites the of pandemic. lines the in of studies have slowed instance of safely we predict pursuing along much going further months spared. the been we hard go go, a before demonstrate understand with can European stopped to that in relative over is all opening for but have consider terms the investigators. possibility

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gentlemen call. Ladies for and for you us thank today's joining

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