Cyclacel Pharmaceuticals (CYCC) 11 Nov 212021 Q3 Earnings call transcript

Good afternoon and welcome to the Cyclacel Pharmaceuticals’ Third Quarter 2021 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 email to the address, ir@cyclacel.com. [Operator Instructions] Please note, today’s call is being recorded. to conference like the over now Company. would turn call the to I

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

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

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

any of Executive time, information. an and Officer. be followed Paul Cyclacel’s judgment by a Cyclacel overview Medical begin President would Kirschbaum, of to session. of Finance does statements progress will Mark to which I highlights this represent Spiro. Spiro quarter McBarron, like call XXXX, are; Executive All our provide and over our Spiro Chief Operating Chief for and will financial clinical business strategy and take and President to will President, turn Dr. of and with on other Senior programs the the At third Q&A forward-looking Rombotis, Chief projections Officer; today, and our Vice us today responsibility Paul as Vice update and not Officer; With such

an fadra call joining PLKX begin across or our and our third I update or you, making would inhibitor, our CDKX/X the programs, like are providing and Arena we business for the us for oral today our CYCXXX and update progress quarter XXX. Thank you, two fadraciclib thank call. inhibitor, to by on everyone oral

of Phase for our of operating studies a our fadra IND continued of Phase quarter study X/X oral characterized was execution for a two opening X/X plan an third The by XXX. with filing and

now More two our a first in have announced fadra lymphomas. XXX-XXX fadra solid and recently, enrolled or We our of levels XXX-XXX patients the in we patients dosing patients study, tumors patient in dosing with study in total with designated across leukemia.

with fadra choice X/X been we And We study to with IND, two study Phase potential IND XXXX. solid has the be outcomes but with also year which of FDA next have early Well for XX the experiments an by It to XXX of from outcomes filed deliver preclinical open or different Company, to many to cancer waiting projected on FDA oral preparing in goal certain we cohorts pleased for part cash histologies are in study. we this our ongoing are funded for patients as is the as on track supporting an of on tumors. through busy for shots review year. deliver submission the this are a studies these supported proof-of-concept

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in basket dosed to to the enroll with cohorts fadra dosed DLs. X have in action. week. DLX on subsequent fadra’s we XXX-XXX in being which seven total, a cohorts or report a at dosing bid study, the addition were efficacy. the or goal, treated being patients patients the of XXX-XXX, X bid X single in We lymphoma initial cohorts shots and followed milligrams emerging fadra. apoptosis level in solid for Initial enabling as like available for important first In and In up XX are expect two and tumor in at to week. cohort based tumor receive a cohorts designed days in at from biomarkers is and care. relevant days leukemia solid dosing are assessment can fadra XX treat patients and that a combination fadra lymphoma patients tolerated well daily orally-administered milligrams fadra DLX, for of XX far to mechanism thus XX five drugs to contain or we solid agent studies of for In three six of patients believe is will fadra leukemia. with X In standard levels starting tumors Oral outcomes XXX-XXX,

two intravenously-administered days observed durable, partial at with week. XXX response a As reminder, milligram a fadra was

to in recruitment a XXX-XXX. RPXD at located respectively centers opened is to move Europe, rapidly stage. We With into the for enrolling expect determine added four of of With of in Asia selected study Both Hope currently of to internationally-recognized pace we sides Anderson sites, pleased City one and with for the which with cancer cohort have been expertise Two enrollment. Centers. and Cancer already the and additional XXX-XXX are total their MD interest types were tumor fadra.

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is IND the Phase in time, orally of novel, along at that be we data from open to in study inhibitor other a tumors included supported turn the cohorts XXX, XXX strongly as Let available biologically with our in which filed to XXX for with that This treatment study, inhibitor. strategy the PLKX the now agent. show FDA, Having PLKX for we’ll expect to of X/X is early details XXXX. us dosing the preclinical But strategy solid the developments. a provide by our differentiated single

types have promising by Specifically, solid oral preclinical as are given patient-derived investigators could daily collaborating of in Cyclacel studies a clinical specimens If sensitivity alternative cancers. as upcoming expansion XXX the of dosing. findings liquid demonstrated monotherapy The emerge reproduced tumor studies, and XXX in to and the this of multiple building to taken for candidates By the of company’s result in most should one three our periods ongoing a data-rich lead exciting two quarter which have Phase for very end together, clinical we to our clinical the is first in XXXX, X/X programs Cyclacel. of trials, the history. up period certain expect

we showed We IV-formulation fadra. be half-life added patients. daily positioning the fadra of attracted recognized new including and a XXXX concentration the of a of relationship convenient and Well an that an how relative other scheduled or oral the As durable with between considerable fadra, clinical is time to led pharmacokinetic presented enzymes. half-life or to of today’s our dosed thought ongoing had the convenience mature fadra fadra success oral of invested daily intermittent now bioavailability of in to especially activity, pandemic. drug the therapies Pfizer’s studying our variety benefit an and weekly dosing formulation curve. oral CDK we stage conclude therefore targeting CDK is of but dosing, midst under This was important Ibrance both CDK inhibitors, it be intravenous durable these clearly of believe also of worth drugs be such Several resource an October first-generation would patients, agent drugs datasets the that is developers oral With the the demonstrated and capable on attention must target a discuss for engagement. were fadra investors. and begin target development, development optimally capable to considering. could us in area The of are as as intravenous call in not previous These strong to twice dosing similar single oral differentiated. formulation Effective once anticancer X-hour maximum therapy. drug that engagement data IV-administered for We have

mechanism both targeting, confer anticancer hope present may candidates. clinical quarter Having dual financials. exciting featuring fadra Cyclacel’s findings the the Paul? for a drug within research like turn to months ongoing of activities, of ahead, third formally review targeting McBarron, various We CDKX comparative preventing call of would our and By progress now is the that a also to cancers several these resistance women’s when two expression is advantage Paul cell with a our pathway the self-proliferation help addresses over As a lead many to reviewed of our clinic. important the E. it types, three CDKX, CDKX, mostly of restore escape fadra apoptosis targeting inhibits contributes regulation an elevated, inhibited, of can both to proteins and MYC. when cyclin as inhibitor selective transcriptional abnormally is by cancer cyclin By CDKX, in inhibits MCLX within E highly anti-apoptotic and directly in the ways. the and tumor fadra to In cycle in I such fadra cell believe CDKX we therapies. programs

Thank you, Spiro.

September million clinical cash for three June of Phase activities. As in XXth, and the by the the due relating by to as compared in primarily same $XX.X XXXX studies period two million by were XXXX, to million XXth, $XX.X $X.X cash operating million million September cash $X.X The XXth, ended and of $X.X due expenses months three clinical opening and for September XXth, equivalents approximately financing million expenses of totaled XXXX. X/X of compared to months was as ended manufacturing. XXXX fadra R&D and used $X.X for $X.X supply offset increased $X.X decrease development net the million provided Research activities, to million to cash XXXX.

programs were R&D United Additionally, and clinical ended the manufacturing related trial three increased preclinical CYCXXX months supply September as and for million of and the $X and CYCXXX increased to compared million, the XXXX. team. same XXth, million $X.X and previous $X XXXX, planned for development a to tax now currently expenses of in the credit. evaluation R&D September for $X.X credits period as The XXXX the due early for expenses the for and General clinical take Net recruitment quarter same the resources $X.X are expenditure Company administrative costs through fund to in $X.X XXXX, estimates for due that ready was three questions. loss eligible XXth, the compared we XXXX. $X.X months research of progressed. year the the the were tax ended period to million compared for XXXX million same three million professional XXth, Operator, to to for September to expenses in relating cash increase period The will the the months legal expansion million Kingdom ended

We’ll take Jonathan Instructions] first [Operator Capital. ROTH a from Aschoff question of

or you I randomized questions. learn single solid from And first What entirely a the tumor to or progress. own have could be know would must on learning the deliver they that? be could be leukemia something folks, an Hi, And trials clinical your that if know must just guys. couple Congrats from opinion with FDA something pivotal arm? something and of trials in on the competing you there fadraciclib programs influence

Jonathan, thank question. you for your

best I the versus think, Mark Single person be randomized [technical please. that. to you’ll answer difficulty],

nice to we less deal in a I to neither activity for possible. have having that looking forward believe type It’s that Essentially tumor is the question you I’m pivotal trial, which know given to go with.

your I tumor depends response, depends really question think which it so on answer the on really and to it type.

more designation. of But, for where going – to breakthrough of earlier believe a it be disease, most that going number space of to towards single relapsed would do kind required so in If be situations probably is of where now to on our we break areas upfront a we trial. will randomized single lines arm. go be biasing a the trial or trial it a then terms a a would refractory for these potential focus therapy, right are We rapid arm for is of adequate

data question solid first going Okay. makes other might be ask half those last Guys, which would the than same sense XXXX same the I we better first slide your guess any of if the to fadra? when answer And oral for XXX? I’m was is sense. per I deck as see tumor the for guessing for

Yes.

this very occur we’ll report in with to responses we be proof-of-concept are the needs about of certain study can maybe that, upside keen surprise to the on type durability if which we escalation obviously that. dose were think it’ll optimistic speculate but And follow-up, phase. to I the

we As we interest. of also response, at exciting see patients dose appropriate XX% I very of that not and remarks, see could Company in it and below for that certainly to mentioned on the course, of wish the would it RPXD happen tumors since and the to our answer patients Should be with get is expectation a both and the the that time. drug response, the drug in my typically hinges enrolling escalation physicians prepared

Okay. you, Thank guys.

Thank you, Jonathan.

Raja Kumar Instructions] [Operator Capital. Brookline We’ll move to next of

also taking have to sites so for and like this think Thanks patients dose? sense four sites questions in the in regard on on participating enrolling board, you you know site, how proof-of-concept congratulations can you be all the some progress. looks once will my dose start escalation you the have also And the quickly phase? you a additional effective of With of it the

Mark, Thanks please? that to for take your as question. well, would you like

Yeah, sure.

additional sites added studies. four will portion the the X actually X there these increase number Phase for the as the of are speed in So be sites Phase trial, for to

number are open. along very of looking you moment very So much very to on here move we determine enthusiasm anticipate is we various quickly. Phase as timelines this trial investigators’ have. you we when dose X know that levels Things the Phase that the they way the depending that is pretty But reach is how And the prove see the our we will trials. drug There roll designed is high from of immediately our the cohorts will can well good. the into tolerated, dose, X that

in now on and adding level said, the we be and when we more we as components study adding number had global, – we’re we’ll have X get United of Phase high we the are four – to sites four patients. for that trials also sites the So, States the

of the to some them indications enroll showing of in in cutoff up you’re or more or and in them to of terms you trial terms indications? a are many of indications is there continue one proof-of-concept the each if enroll how also And will follow the Okay. patients know you there going patients these of

with they that’s also think we beauty that the you we’ll show I know feet. design, will as Well sense this the bow of see in information clearly their

know will some that think know everywhere Phase the we’ve the X certainly and seen in thinking responses of advantage arms you investigators than is better of about already the where obviously others, Phase I X. in the course, this include we’re probably

and we’ll of proof-of-concept types the of Phase get we’re some some that So preliminary those in approved. it will ready because be X,

you that drive think will I responses accrual. the – know So, the

to, that if add So need for things respond flexibility basket, we have to we will if arms go in other a from and we there. example,

– Okay

that but you’re Let audience the if audience more is dynamics Mark’s me color may to of – know enrolment obviously reply Kumar, so familiar, add the critical. to needs the driving understand which some some I I

few six the First are we’re units are available These halfway not the two slots of the actually for groups departments of City through study as the all dose site, X about which as of two it’s well There’s MD pursuing all, this it’s Anderson, Hope for who now. at lymphoma in and open. escalation Phase part study.

that have site are X well, the group Phase will as we We who that year. types opened in two just in end towards The Phase design. centers final fixed our site, third last the specific the because expertise their the part final of as well – a unit cancer mentioned non-US as of of join X X group fifth were Phase

the a way Phase answer we in So see get them the of your to strong enrolling by would we’re who way which the of reason I is in suggest typical ahead already interest is and patients industry X underlines here ways the remark to six go jumping at that, benchmark. practice. enrolled I to in people was excitement We by took starting that because us question patient some we July this going faster like their than the tumors half benchmark assume partially quiet to these the investigators. which desire definition think typical in into is early, study The the typically get to about month to from into presented Mark’s a a

reasons, Very these be all can stage, recommended it proof-of-concepts will once move we very where into fast the expected. we that feel know middle for So times. the dose, exciting X Phase

the of And to CYCXXX, terms be the Yeah, you pass, in you that’s waiting else done great. there? to what just are start to to know need for days XX trials

correct, essentially Kumar. That’s

we sites believe no I be it study we to FDA we file lined we able then they we review review and that being at open a XXX, proposed up, fadra think which means, should with questions. that the for but the no learn I have to once experience a INDs days, will enroll for open the enrollment, with the study the have also FDA patients have went to about XX the lot similar if would questions there was already already

So if expect experience year to similar we enrollment. have the the should to turn of we start a

Okay, great. Thanks so much.

Thank you, Kumar.

And we’ll of DeGeeter Instructions] to [Operator Kevin next move Oppenheimer.

for questions. on DeGeeter. just is this I have Kevin Suzanne in actually Hi, calling two

first The fadraciclib. question on

So the time need What this? you will think during do you follow of show demonstrate patients is the follow-up to mentioned potentially the response. that to period you first of to minimum period durability

Susan think question, thank in of of for question all. you can Mark, – first terms I that is you histologies. your deal different Mark, with this the a perhaps

the the hard defined you Yeah, protocol, is it’s to know by minimum say right.

a to need month question. know they establish to you fully for in toxicity go the order So

you longer, long can receive they that that at, time, possible can potentially usually the So is We know these some response a minimum as disease XX minimum as – it. drug, in bit I they a cycle If have we’re point little tolerate either which of the that be anticipate way for days. the at it is mean they to types amount time but happen. of looking

drug not there’s don’t could the we on amount – limit of get. time they So, a set have a

takes time know minimum days. to a drug So like it that. full for the enrollment But for have treatment you response, several for providing if XX them we are is months study the

have Got histologies my collaborative actually initiating CYCXXX. preclinical these of the selected prior guys the interest question second evidence are for it, How to And that is makes on studies? is sense. studies you there which are

been said XXX oral of very have which can First have the initiated review, happen shortly certainly the this that so disclosed selected. of question we address how breast but publicly, program Mark, of will been will over only not colorectal after and the two yet, as all, to – perspective a be have end the is I you. histology Mark

I in Hope. actually very of on some analogy background brief we of was days was in back academia know City my answer, the through at me, you through look extensively this in Yeah, mean, the an I investigator field

So, on well, I very, published area know it. this very

that tumors. or part be So, it PLKX amplified driven either know you the there by are the is that are of of number tumors activity believed pathway it’s drive to

data that you published less group tumors sensitive know action. the suggest we’re as or are at There’s also some that sensitive certain preclinical this analogy known of – and has and So, this there. more looking the this mode very – are past more done to in

So, I and level us of team working think with preclinically between us are and that both getting on investigators clinically. we’ve very high

to sensitive So that responses an just enrolled And group in an new study cohort to pathway. the this are that if basket, can the out be individual think I have we identified seen those will between that that a that mechanism, submitted most that develops are arm that the science and all that respond so then we into as basket cancer we of maybe the there tumors built have the if as as development trial optimal of the basket registration we tumors come that arm. them tumors importantly, in does, FDA the we design this have towards

we then much open future support pathway. we’ll the have in summary, than should and out come and all data for other we in are clinical I respond data to the we’d one mind in that pretty many So, have cover think will to think basis that and

more to audience. your bit helpful which the for to me Mark’s also may add be let color question, reply Suzanne, a

publicly it does past, have in biologically target the As but is XXX hit there very it drugs we had differently, as mentioned earlier PLKX other believe or now, will tumor practice be for study primary open. once well our therefore does to and this the at disclosed, as in different as biology how and mechanism types is that work explained color is very It guide as information implication us the as would the well we just time Mark selection the understood appears. works. on of types is clinical we providing And additional is this select that quarterly remarks, additional as tumor

So, forward this if than go much it’s we’re looking according certainly if away at should that, few again, very to weeks plan, our a we to sooner quarterly things only have call. be able discussion next to not,

very helpful. Again, I’ll you. back the in that’s jump Thank queue.

Thank you, Suzanne.

And time, management closing I’d at for call remarks. happy this be return the to to

in you, you participating Leo. call. Cyclacel’s quarter for And Thank XXXX third thank all

think milestones track programs, enrollment achieve shots Phase XX quarters. fadra clinical on tumors is for we leukemia. in remain our fadra initiation ongoing it evident trial coming solid the with on building our study of and are I momentum to over in significant the our the goal deliver and in We Phase that across X/X X/X on of the

In addition, like shareholders plan or for solid thank the conferences of their these our at study the to events, end progress forward continued some Operator, look this time, upcoming to in-person. you may we XXXX, support and X/X you tumors on XXX at either virtually in followed meeting call. in you updating early Ahead XXX we to would in Phase initiate we your leukemias. of by of and

conclude This today’s does call. conference

lines and a now disconnect everyone, good day. have may You your