Cyclacel Pharmaceuticals (CYCC) 13 Nov 232023 Q3 Earnings call transcript

Good afternoon, and welcome to the Cyclacel Pharmaceuticals Third Quarter 2023 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. Please go ahead.

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the third quarter of 2023.

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 our set among affect involve XX-K. and our the uncertainties our other and company's Securities Commission, in forth discussed statements that the and prospects, risks those press things, with which XX-Q in filings Forms Exchange include,

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

well. or Thank for cycle progressing clinical stage fadraciclib cell and or are with our you, us our plogo Grace, Both thank update. quarterly and you, everyone, plogosertib business for joining programs today fadra

subsequent data used recommended of or II expect RPXD to to Phase escalation in with and fadra determination shortly the We complete report dose be studies. dose

potential various based We number have single innovative the report preclinical dosing supporting be demonstrated also implemented demonstrated fadra interim a best-in-class study classes. Based and anticancer disclose patients which the this switch, program, disease several from novel and with and and in escalation levels, properties at that activity. the partial clinical plogo, of plogo good stable medicines. lymphoma plogo on believe in disease oral have tolerability. of oral class its with epigenetic for drug. stable fadra data to have across and patients fadra agent we With we form in capsule-to-tablet results response observed solid with of complete the receiving seen response, dose expect respective data With mechanism. Both on activity, a solid patients the their fadra, to now in and tumors We is have have tumors convenient the plogo tablet the low both novel more encouraging we

is convenient mouth. capsules We for expect taking that more the reduces patients of by many burden the tablet and

fadra be used strategic would of represents are up tablet an As a ultimately it the commercial to the value investment community. licensee. At reaches the time, by companies in small-cap if the present market, the biotech favor in not or put also switch acquirer

value. I patients is This team work term. offering pharmaceutical the by for and our across as clinical by enthusiasm our options hard their attested investigators Cyclacel building and the work medicines in the been has trial at value However, clinical the their interest discuss studies call of the fadra the clinical doing our long discovered demonstrated realize care. stockholders and to globe in strategic Cyclacel, the will innovative, turn and by now over By to to Mark our opportunity progress both to we to clinical which high-value results. some Mark? developing the plogo hope were in X of review medicines, the offer

CDKX, tumor far. patients. ovarian enrolled XX has and solid lymphoma Fadra patients, T-cell X patients, patients anticancer well gynecological X including out of been including X of X in of neck; with X, out fadra, has of head CDKX pancreatic; to cancer. Fadra inhibiting X out of so antitumor of both CDKX out Of and a study activity I/II X X XX have profile prostate; Phase activity had hepatocellular; endometrial, colorectal X, unique out PR of out XXX-XXX biliary observed, tolerated, CDKX X cancers; the another, In Spiro. of been you, enhanced in X, these has Thank XX tract we cervical; activity X, X, together X treated compared alone. disease cancer, stable and X leading cholangiocarcinoma complement out one and X, either which to and out and or or

tumor toxicity on at dosing twice to week able current the days the been maintain inhibitory have daily dose a continuous X with We level. cells hematologic pressure without

We are and expect the escalation shortly. to the dose one study patient RPXD away the of segment declare from completing

in We This of are may the for PK pathways. is have the large the and also for through XXXX, on segment PD design rapid guide populations. observed mutational Phase identified catalysts predictive The that II data identified Phase to multiple provides clinical the many we mutational of and activity. exciting tumor and leading molecular patterns study RNA-Seq opportunity of the profile NGS to patient selection study. and studying for The II results a XXX-XXX frequently be and transition may registration

eighth independent tumor As cohorts provides the a relevant by biomarkers. reminder, cohort defined type an protocol basket by X for and

order objectives. to clinical our more overseas major sites Phase the achieve in rapidly sites have in and I our We one to added current U.S. enrollment

now Let turned PLKX program. us inhibitor our to

as that escalating when for PLKX plogo activity very inhibitor are a plogo novel lymphomas. tumors low as advanced a XXX-XXX patients with emerged solid and excited doses. In new epigenetic has treatment we continuously oral at our study, with given in are doses We evaluating

levels plogo biliary with X of dosing currently with novel by mutations. so a mutations X, This daily drug-related level Patients carrying several X crucial X days, far, through role epigenetic presence or populations. in observed administered of is types, enrolling either once a We no have XX X. anticancer tumor program, this tumor plogo patients other frequent for SAEs large acts thus consecutive and approach, identified through preclinical enrolled our weeks mechanism. we With may ovarian In lung, activity X these have dose X epigenetic weeks of certain X. tumor have mouth out in cell novel out non-small the common far. In have tract activity are dose for patients in that we

Following approach. of research benefit subsets these from findings, will this the help we have tumor activity scientific and entered into to with further novel define most that centers the this major collaborations global characterize plogo

of As findings, the enroll on call selected as over additional turn corroborate biomarkers. I will now and the patient more future, our study, or second basis Paul expansion these specifically review to our results. X of we in may I/II an current cohorts Phase possibly to financial data quarter such the

Thank you, Mark.

the as XXXX, XX, period programs $XX.X $X.X ended for costs months the X end R&D XXXX, the to same million of used for operating anticipated XX, to months the that the could $X.X take September together net to credits extend to of months estimates $X.X September includes of to $X.X an The $X.X XXXX, for XXXX. Operator, period period XXXX. development compared period As last credits for administrative for million of tax million cash increased correlated XXXX. in of legislative in $X.X claimed. million million that ended the $XX.X expenses development previous September ended previous X September took which million for period ended in the equivalents plan Net year. to same for for discretionary tax to tax XXXX. General the for to is to the million September same company million totaled $X.X cash due months which was $X.X in of not as of the for ended compared compared professional same as plogo to the R&D The currently same year. $X scale-up months September have ended incurred, to expenditures, and tax in the same its million to September questions. amount million XX, and to as through the compared in and of X $X.X ready The introduction the quarter. Research compared XXXX, for X as were and into the million income $X.X available which reduced period the expenses credit The XX, million development XXXX due XXXX. X operating same XX, and available million December related XXXX, for of ended quarter for or now million the XX, XXXX, loss compared million Total million were for months decrease September $X.X expenses R&D to the could million X of XXXX and approximately directly XXXX. relating fees XXXX, period XXXX, with expenditure. due cash $X.X XX, fadra fund the X the expenses period research form. for X April the were was activities taken changes of will $X.X qualifying development first receipt year. United of and planned cash XX, of effect the nonrecurring compared the research ended months manufacture September in are XXXX, to million was in XXXX, associated be compared million for other were $XX.X income tablet $X.X compared XXXX, $X.X Kingdom to Net research XX, XX, months credits we're were $X.X same the million with second R&D and

comes Ahu [Operator from question Instructions] Demir, Thalmann. Our first Ladenburg

questions. X have I

plan Or known we First studies. type to And you one novel studies? they do biomarkers What is they when biomarkers? disclose the before? seen biomarker targets? regarding and have that Are the of on biomarker report are

past so Thank terms question, known Ahu. biomarkers and your are on you in scans and of reports next-gen These for sequencing, appearance forth.

year. novel are believe be as hypothesis we discovery the further that and class, the next obviously around said, has for in I as this present reported update. We early we've We're they these would clinical upcoming be think to expect occur, is But of sufficient for give important full this a we announcement. there far the probably when data medical been or deadlines not to at for that the we made hoping support that when CDK end made to and will class. Phase clinic. Disclosure pursued concerned year the we are meetings, previously However, the as as should I

very is know is the PLK on program. curious. am the other We epigenetic question second My aspect unique, unlike any plogo I inhibitor.

of that XX curious just So do on indications already observe? unique Given there what given anything in patients, activity clinical agent that you the that's you targeting? you so certain activity see type epigenetic dosed Is the activity.

Mark, is for believe I an expert who in Mark? a this also question is epigenetics.

have we in low but seeing disclose, of to early prolonged very little at levels a very stable still these been a disease is it of number tumors. some Well, dose bad

happening be that for it would And doses. the low out led really interesting the search of story. a mechanism this at So these turns be to why

I all that. Spiro reveal the the think there'll some near things abstracts in some be disclosure said, future, at and we'll as times, and

question Sounds good. even it increase, the And as is pointed -- the my there like clinical activities. looks the on manufacturing an last financials. is on out Paul, you the and

increase the we much how quarters. should we increase? next So to curious continue the So going Is model in manufacturing expecting forecast? how to are

question. Thanks Ahu. exactly, No, for the

as form cablet a So from capsule mentioned, Spiro move the cost we form. was, manufacturing the to as

should the QX, so that in happened that ingredient was active manufacturing decline which in QX. So

Jonathan Aschoff, comes Instructions] ROTH MKM. [Operator question from Our next

where say could now? strategic move to I level clarity that at. about give looking the was real you're us gating you any of factor as if you the it Or conversation a to what's a there wondering anything Can options from is fadraciclib's probably interest?

parties points Jonathan. in This you, is different have before from in strategic in who multiple calls. comes next-gen This these CDKs different fadraciclib, is in interest have time topic Thank interest hurdle a rates. and discussed we There particular. at

I of would including think interest biomarkers, much future the disclosure the mentioned is that bring near an the the catalyst disease, I is patient activity, population PR but future but which CR, possibly not which the trials. think to questioner, evidence to we of have in we also very home now preliminary, important as previous and only single-agent target now know I stable of

this parties. that interest, strategic expect look we to relevant would further continue those with I and catalyze forward discussions So would

us X finishing right? want dose at Also lastly, off Phase if don't tell I That's the you're fadra or [indiscernible]. XA, to you

back your come Well, a I and Mark, question Mark, and don't can it's a think RPXD? I for bit why color. But you guess take about give then that? you more What's

know, XA. patient you from Well, one we're finishing away

will So I'm hoping it. be that that,

very looks data the good. -- have We

we formally what we want to We then, have those It be page at will to shown and dose this be I'm don't conclude, able announce. But seems so know. that we'll it. hoping until doing levels, last

And any dosing you do telling different Okay. correct? need of to Mark, that schedule, slightly nothing there's sort you

very happy now, it say We're but No. right is as complete. until anything can't it we says

further [Operator the to like Instructions] over now queue would remarks. in for call We have at back I to the questions no company turn time. this closing the

quarter Cyclacel's Thank are you, operator, our in of Phase and all stage starting Both you earnings catalysts their important thanks programs third approaching classes. therapeutic for to such competitive joining a strong with profile call. II proof-of-concept as

in in data advanced tumors solid Phase are: As forward time, dose action with fadra patients lymphoma; of call. further at the plogosertib and you of may a and and you first to escalation Phase study of at the lymphoma; some mechanism key patients of XXX-XXX reminder, tumors with advanced XXX-XXX to this stage patients providing the of report study lymphoma; from report study final RPXD and oral and stage milestones you novel determination with solid dosed XXX-XXX upcoming the data our I hope end II upcoming patient with in Operator, fadra meet in plogo. We conferences. with solid tumors elaborate from advanced oral and oral of look updates from

you participation. This today's Thank does your for program. conclude

disconnect may time. You any at