CYCC - Earnings call transcript Q1 2022 | Cyclacel Pharmaceuticals, Inc.

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Operator

Good afternoon, and welcome to the Cyclacel Pharmaceuticals First Quarter 2022 Results Conference Call and Webcast. [Operator Instructions]. Please note, today's call is being recorded. I would now like to turn the conference call over to the company.

Irina Koffler

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's Financial Results and Business Highlights for the first quarter of 2022.

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

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

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

Spiro Rombotis

everyone, you, our Despite to plan. for in on headwind has new At today from expanding us patients and has programs this our the update. Cyclacel joining well made a Irina, the team clinical that report remains happy quarter XXXX clinical for these first significant into challenges, of in XXXX. enrolling development I development ongoing business the many biotechnology you, am companies. executed thank trials progress present, Thank clinical continued in quarterly we

leading dedication our of abroad. to trials We candidates I/II and are and the strong U.S. speaks the X our Such continue productivity volumes separate to centers patients with across registration-directed CYCXXX. dosing clinical with in skill relationships now we cancer and the several drug X Phase team fadraciclib build and

assets our fadraciclib. Importantly, for key waiting To several are broad innovators Life sufficient oral candidates with our rewarded have estimate our end, resources initial for we operations initial Despite track competitive highlighting equities, meet data weeks markets our position. to through deliver planned for fund on be are to pressure will during and the stockholders, when recover. competitive XXXX, X that data mid-XXXX for Science selling biopharma placed leadership this to clinical milestones we including drug well we on

Let us update you progress or in for fadra inhibitor our on with fadraciclib X/X short. our CDK program

and advanced to tumors in coming with reached dose has escalation studies in evaluating level advanced from more patients in with time. with these solid continue our DLX, analysis data studies, dose exposure shown patients have proportional real or the dose the stage. X X The DLs last with first update, is fadra. Since through treated of XX in enroll the study Phase oral patients We I/II X fadra most XXX-XXX lymphomas. Pharmacokinetic

well no We are DLTs and observed has dose-limiting pleased been fadra or far. to been have report thus that tolerated toxicities

daily entire X-week to study the the with cycle. in Monday level dosed escalated the week As dosing each dose that continuously provided Friday protocol, in patients X through is treatment has from

will been pharmacodynamic threshold the and exposure and has determine activity, DLX, last review specified protocol, data pharmacokinetic I Following a X completion of we whether of safety, observed. all patients Phase from in the appropriate enrollment of

is weeks completing II RPXD, determine with these will Recommended in lymphomas. profiles We tumors coming will totality that solid on we determine and to II in Phase addition, I/II In of for XXXX. patients Phase now XXX-XXX, of The track study or dose, In the Center and Cancer and enrolled patients the patients fadra half XXX-XXX the patients with MD protein data and remain Anderson help DLX analyze and open of second of study, our correlative second anticipate pharmacogenomic the evaluated initiate leukemias. levels. regarding City data enrolling are being Both fully with us Hope analyses of Phase part recruited. in in advanced fadra

We PK parallel tumor in this study are and findings evaluating safety in solid program. in with the

study with blood levels tolerate determine this than can XXX-XXX. patients As different may treatment often higher RPXD a cancers

will data or MCLX explore that whereas preclinical cell MD deletion, in with for hematological and reduced oral a in Cancer both of XXX-XXX lymphocytic with difficult-to-treat of As primary of by alone and CDKX from inhibited was lines. as XXp combinations agent a levels leukemia activity chronic effective effective. primary single Anderson fadraciclib recently The not is the also lines of venetoclax. malignancies lines Center. with Single supported fadra was various against approved and each venetoclax This by oral strategy single-agent researchers therapies confirmed mediated across fadra CLL cell reminder, including highly published chromosomal and activity venetoclax. They combination combination CLL CLL agent drug showed fadraciclib transcription all

CDKX, selective therapeutics. competitors anticancer believe of CDKX fadra is levels of a transcriptional tumor E, CDKX been is We matched is CDKX cyclin which with like by advantage, their BCLX enabling mechanism and such cell of has fadra fadra daily oral treatment mechanism pressure tumors. inhibitor to proteins daily oral Continuous suppresses of as suppresses to thought or when FDA-approved regrowth both to recovery highly cancer is class dose CDKX and addicted. proteins cancer inhibitor require protein we an a how apoptosis cancer and field. the can in become venetoclax, MYC X only inhibited. MCLX, the ways. competitive CDKX, with in important other apoptosis by By this in anti-apoptotic prevent profile cells the drugs dosing. daily a targeting a help As important is an required restore MCLX medicine targeting safety Dosing also constant that in schedule CDK continuous continuous to Applying Targeting fadra MYC escape jams a expression which anti-apoptotic not

proof-of-concept will Hope Center inhibitor, escalation turn have in biological fadra was treatment streamlined and of pleased our CYCXXX apoptosis City that addition registration-directed in to PLKX XXX-XXX with structural Anderson short. of of April, Similarly, XXX I/II We leukemia sites patients in single potency of the with tract, solid design. in for We designed as XXX-XXX a of that its is the We're malignancies. and be and lung, Consequently, we cancer PLK other with oral preclinical patients including differentiated a clinical the tumors RPXD. enrolled mutant explore determine and In in now solid Once to MD or development study, multiple been have for [indiscernible] will to bladder, Cancer a breast, mechanistically activity including established, XXX Simon up enabling and to these initially opened strategy, to XXX for X have XXX for our its characteristics Phase to and for and leverage us currently plan high the II single-agent In beginning mechanism. biological hematological X+X trial Phase to DLX. RPXD dose design X-stage also and initial potential Let patients stage trial immediately biliary the can a cohort colorectal, and a models XXX-XXX as into XXX and administered safety liver enter trial tumors properties will lymphomas. believe activity distinct in that to anticancer and mechanism or promising announced our range across both development. relevant KRAS types using inhibitors lymphomas. tumor stage, dosed a first has patient with our agent suggest this cohorts,

cohort In patients to addition, with the mechanism. biomarkers basket will relevant an drug's X enroll

expected provide to with will dose progress to status the Having the call half updates progresses our XXXX. clinical Paul will of data I review reviewed I We financials. our the in first over of escalation turn the our and Phase programs, as Paul? initial

Paul McBarron

Spiro. you, Thank

December $XX.X million cash XXXX. as of million of XXXX, As totaled $XX.X equivalents and March compared cash XX, XX, to

estimates $X.X the to non-clinical cash and receipt United with are costs clinical period March in Following trials XX, the $X.X research forma quarter months an in Phase the tax $X.X pro development after ended with million increase XXXX in fadra for as in to receipts for credits the of compared equivalents ended March XX, months million expenses cash same that programs available $X.X XXXX compared R&D XXXX, through its XXXX. will XXXX, fadraciclib million or cash end X Kingdom the for ongoing million same associated and currently R&D the to in and expenditure. to clinical of $X.X for company planned and I/II royalty studies as along Research fund The in X development million XX, due were June million. evaluating relating expenses $XX.X March were XXXX. million increase period trial $X

March quarter Additionally, $X.X $X.X for research due $X.X $X.X million tax lymphomas. consequence in primarily Total XXXX compared decrease ended for compared months evaluating May and period recruitment clinical in questions. XXXX to tumors XXXX, Phase months royalty qualifying XXXX in for the in previous for direct of development and Thermo of in expenses million The as ended the March X ready ended $X.X quarter other year R&D million million to of previous to increased December are million income receipts Scientific. of is as financial associated were R&D period trial XXXX. XX, the XXXX. million in a to ended the to $X.X in the XX, same XX, to to loss compared of months start in million Fisher for the expenses XXXX, received million costs $X.X the March million study, the X March United we same were the XX, ended $X.X Net from the for net period for were and of a XXXX, X period received expenditure. for of now $X.X the year ending same and compared XXXX, months related March General million the period to Kingdom XX, XXXX, as to same X with ended Tax million compared respect income increase XXXX, the solid for opening to $X.X I/II credits related for and the costs. XX, take credit $X.X XX, the CYCXXX the was million Operator, was same CYCXXX the to $X.X sites due administrative year. March was professional

Operator

Instructions]. [Operator

our Kevin Oppenheimer take question of will DeGeeter We & Company. from first

Kevin DeGeeter

in guess really lot I to fadra, enrollment. a on questions. of of terms progress two oral Congrats solid regard with Spiro,

just want been includes with patients appreciate regard any have no First, X? if to X, I that to cohort cohort comment at your dosed date? exposures to DLTs any in

Spiro Rombotis

Kevin. you Mark, you for question. that? Thank Sure, your would please answer

Mark Kirschbaum

almost well. answer is and patient cycle first the the doing to positive. question we Yes, a done The with is who's very have

Kevin DeGeeter

Great. update to expect time on in the any of then oral venue frame And the frame Still fadra update tumors. in reasonable or perspective terms community the solid for dose escalation investment time just to or summer there.. an in

Spiro Rombotis

Yes.

events, as summer, R&D the in we the we company So data prepared R&D than in of happen summer probably to Day remarks. this totality on the becoming expect is of the summer. available course, early more But do depends that, like mentioned late going to

this imminent. So is

Kevin DeGeeter

the dose with with is the light and process about on, starting one of just you in where Can remind we've hematologic thought dose there of their the kind of then of in of IV fadra escalation, experienced solid to us And particularly to regard malignancy XXX-XXX, pace seen how this population? in think relative being might tumors kind the study. exposures Terrific.

Spiro Rombotis

question if the Yes. please behind also for answer question dosing. strategy This a is heme on the the Mark, you could

Mark Kirschbaum

Sure.

just it's trial doses So And in way the we first. X bring taking tumor in a solid dosing. the trial. tumor ahead. identical tumor have which with the of trial to would the of And solid has steps leukemia line pulled we're course, the start was solid It essentially that to question now

will it but closed So shortly. there's gap, very be a

Operator

comes question Landenburg Ahu Our from Demir next Thalmann. of

Ahu Demir

progress. impressive. on Congratulations is This Group

know do about will first to My sites ask up additional XXX the plan I schedule, on PLK little have? following it's just many inhibitors, you how could active question elaborate be the schedule on you a the dosing dosing as than on different sites So do And question will be program. open? curious I you would how that other well? bit if And many

Spiro Rombotis

as of first there's but that about not your interest reason new I'll based well is away. take this sites Mark large strong which in right strategy. the question, open for a mechanism, is will XXX-XXX behind, second this might the Ahu. drug answer on the And a part for we number question program. the The same dosing X of To the centers open

activity. drug explored was with have single-agent case drugs We very reasons XXX the by also do have than same need the other the the but member of that we carefully, we'll have IV about information move This less pursuing strong been about fadra strategically, to thoroughly to not and and this we family but mechanism. has Volasertib anticancer of may earliest with that sponsors believe

this thoughtfully open number and identify to something as before well carefully we'd sites PD that a very profile So is of as to very do wide we're look to like both going correlates. to and for PK

like I reasons the dosing. to why with X is X the going would that's And the So initial discuss centers probably strategy. best Mark of

Mark Kirschbaum

this very exploring in we're correctly, drug. interested of said Spiro the possibilities single-agent As

So tolerated. is believe oral an we drug, our well have we which studies from

attempting give it's plan. but of potential tolerated, the and hard mechanism but our to oral is to as is I following the as goal action. this getting get as I possible just as and as was the of to the -- to starting, try we're so guess PK continuously maximize predict, frequently tolerated drug the So And that's

Spiro Rombotis

Just to starting to Ahu's give question some more on color dose.

single-digit in in we possibly range. our very in potent we is the slow at the will that which most escalate means drug, drug milligram potent are ever history, We steps. a made Cyclacel This

they the in we other almost you the studies. from this going PLKX their means candidate to which that identical and or very our agents have in space, that ICXXs If far you that note against compare would similar salability, have very potency we're Onvansertib, with not clinical be seen flat away dosing

need Mark dosing course, information Of comfortable right the to we identify, feel very all this but the of escalate strategy. we our need we in and said, program is as other

Ahu Demir

on had One the PLKX inhibitor. of Could the differentiating are remarks elaborate you to differentiating other profile of factors? you a made XXX compared What that?

Spiro Rombotis

which Sure. ago. of XXX I Volasertib, some this in agent you The common, the earliest in context has was potential that. Volasertib for show a drug years case is Thank and with activity, half-life, with we say is days main to in XXX very around In Mark XX long of possibly XXX, X hours. IV the the drug reported single would XXX differentiated the which that the is half short orally, dosing plus. life, Volasertib, given more and a in the or including class, issue as best-in-class explained, profile almost hours have

The orally. hours second drug class, has XX is tolerated. in the to of half-life seems that It well Onvansertib given be

single we not into also a as sponsor differentiated a the That deserves agent. based beginning the for single when drug on agent. plan. evaluation appropriate may of clinical be The it tested XXX combinations as However, has mechanism, that that in straight and feel been biological development an its

produced document hope by will of join top We which is study, data, at will preclinical of will that who event be data. company-owned investigators on which additional able our to some our show some R&D we

strong single-agent have clinical to believe activity fact feasible we and the them pursue to this with that So is clinic. in base

Ahu Demir

last on X the XXX have again program. I question,

at selection, Looking such behind was rationale the indications, the is behind TNBC? letter, different the what indication rationale choosing it? What

Spiro Rombotis

Mark, to like question, would please? you answer Sure. Ahu's

Mark Kirschbaum

PLKX-related mechanism. cohorts targets that a you has see Well, of the since we've the identified that every as X

done have with either data there's mechanism class So preclinical that work, previous published data this independents. on investigators, or work from that we in PLKX was agents

see investigators, response. they with registration they're single-agent group and efficiency we these strategies should all all are if we are adequate -- verified targets So -- these were believe all all with potential

Operator

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

Unidentified Analyst

with X CYCXXX have the question just to regards I Kumar. for program. Shivam I'm

different types, over we PLKX different tissue cancer levels call full So change of in which expression, so expression.

in you for do PLKX for you cancers biomarkers included levels So the that then have that different would the match trial? a expression? over the threshold specific you And have with of

Spiro Rombotis

question, please? Mark, answer this would like to you

Mark Kirschbaum

be that that would best trial to the designed think is I answer question. the answer

lot known built clarify the expression of said, treatment a at there's But have [indiscernible] This study. science point think built as to specifically large into studies a through should this in time, threshold help after and I this we the we of before sensitivity. answer a But have that and that to don't I issue. in amount So question. study, correlative

Unidentified Analyst

Okay.

X follow-up question. Just more

types your going different success trial? have you into the So have versus Or tissue in what do expect Do trial. is trial more you X expectation tissue the the on other? you --

Spiro Rombotis

Mark?

Mark Kirschbaum

Sure.

the have of we flexibility that question. and major last the of trial biostatistical we to and the that X have design the cohorts design specifically with the is So pluses target the

number -- tumor may another a respond So and miss not to there are we number a that -- we'd possible tests like think of of them.

the have we PLKX it suggests comes -- scientific in a haven't that rapidly of So that data field. another this this over tumor as we cohorts well that define that If have we forward basket. as moving may expansion recognized

So has and flexibility the so that And designed cohorts into them if will it see we utility basket these as X independent of open then them and a the take don't patients, cohort we the treat and those that a to cohorts. treat each of then response, to close. have number trial

respond to that able which your identify, large ones that different way hope are types the cost -- into it's answers most because treat X answer it's big of tumor Does that a grouped best So with to be will and all the number likely a to study. normal question. nice be I

Operator

next Aschoff to ROTH Jonathan of We'll Instructions]. move Capital. [Operator

Jonathan Aschoff

might still all? kind cohort. you of curious it's point just November was covered. late. think if there the trial, this since by bit a we in that dose you which at that already it's tumor doing had liquid any been which rethink I if a I joined Is you I so enrolling and was first was at wondering,

Spiro Rombotis

question, excellent market an be the that course, it of discussed attention. give earlier, we this time important could That's to stock pressures an given some

and primarily to is longer this X well X is too logistics. mentioned is failure have to hypomethylating took agents care up. you with inhibitor. venetoclax mechanism. when the open Consider, standard for an The example, almost in good delay the to United treatment the is year-end the to the opportunity sites believe do we However, levels primarily was with us of we of which in because of suited the States, It test process to associated issues. missed be CDK study, that particularly fadraciclib go This due that MCX

open, that hopefully I also move Now the the leukemia both we the regarding fact can the sides state are the rapidly. and that interpolate into that earlier they solid study tumor expect program. remark to data analyze from safety made

know, tolerate As and anticancer we sometimes all of doses patients higher with leukemic therapy.

So this at that the solid we're XK recommended some diverge program possibly determination. is point by a Phase tumor from II

not would that's So this program could or across being But certainly, this levels. reasons once the X now appropriate. consider dose something it's be a of totality more X of we in will get data why X we

we Jonathan. whether malignancy with we're far have Are there for hematologic drug soon and away, will questions, patients answer suited not this So guess Jonathan? I is an any no. other

take So question please. next operator we can the

Operator

to remarks. it lines. to And the for no further Instructions]. [Operator return Mr. Rombotis any we I'd be appears questions closing via the happy have call that phone

Spiro Rombotis

Leo. you, joining call. you, quarter And everyone, Cyclacel's Thank first thank for earnings

fadraciclib which our look for first with next transformative you. initial and data classes. pipeline X multiple We company. believe in period the cancers, and enter their to earlier, respective clinical differentiated that assets CYCXXX, quarters. as strong in providing updates and second As types readouts, key across important potential we poised activity may clinical of expect additional for Thank forward to the Cyclacel is be an oral mentioned We or

Operator

webcast. first quarter results This XXXX call and Pharmaceuticals does Cyclacel conclude conference the

day. And You may have great now disconnect. a everyone

Cyclacel Pharmaceuticals (CYCC) 12 May 222022 Q1 Earnings call transcript