Cyclacel Pharmaceuticals (CYCC) 6 Mar 232022 Q4 Earnings call transcript

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

Good afternoon, everyone and thank you for joining today’s conference call to discuss Cyclacel’s financial results and business highlights for the fourth quarter and full year of 2022.

Before turning the call over to management, I would like to remind everyone that, during this conference call, forward-looking statements made by management are intended to fall within the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended.

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

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

Vice of programs, Chief Executive quarter With Finance which XXXX, us be full Mark Kirschbaum, progress, Rombotis, Spiro Operating Paul and and year followed and with President, today and Cyclacel’s Spiro will Executive Officer; Q&A President and session. by Chief Paul begin our will Officer; highlights strategy clinical Senior fourth on provide and McBarron, Chief overview the will of Vice provide Medical are Dr. business will an Mark President a financial details Officer. and for

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

dose pharmacokinetic commensurate patients. on level Recent those solid engagement lymphoma, we suggests Thank solid thank target you Both dosing, we better joining and fadra XA. tumors plogosertib in have continuous business level in we our pharmacodynamic fadraciclib XXXX. for during X in you, with this clinical are with Irina for are our patients study, are the with achieving lymphoma. which In at oral or update. XXXX, to X patients milestones progress are excellent and deliver oral programs observed than that data made patients levels well-positioned or and Phase dose us tumors dose quarterly X/X In level in fadra and enrolled and today ongoing programs or plogo, from everyone registration-directed on key and

more Phase X level XA enroll dose dose, patients determining recommended or X protocol the with objective the at of will RPXD. per We

after dose X and with activity partial reviewed lymphoma R&D see or type first in T-cell a We a both This were excited in the with study. included treatment October to CTCL; PR of observed XXXX, lymphoma lymphoma, the levels cycle Day in or of or peripheral we first our monotherapy PRs, clinical difficult-to-treat T-cell the PTCL. At PTCL. cutaneous responses patients

tumors XX patients and with stable stable with disease addition, of In for various treatment. a solid lesion X achieved patient’s reductions target cycles disease maintain pancreatic

As Phase X will approach dose stage of we Phase in starting look we to by defined in of proof-of-concept, This studies. avoiding which cohorts POC X to completion delays the fadra are designed designed thus be sequentially the multiple of forward escalation stage. histology, or recruited the study, the inherent consist the parallel,

dose ones cohorts the enroll reported anticancer as It they already we activity expect become is be available. during may Clinical those POC the will data from which that stage. will We this open-label different possible seen that rates. at have fastest stage in escalation be

anticancer activity At and reported advanced first new on early patients has cancer. with signals lung for lymphoma. in non-small at the focuses our ovarian level which of the R&D Plogo already from of Day, also treatment the plogo program, inhibition solid exciting findings and PLKX shown tumors dose cell we

differentiated patients plogo and have study currently has the Dose are sites in also profile. demonstrating biological evidence X. submitting We dose escalation plogo’s advanced, level for

for data the we Phase fadra readouts plogo. from expect key Over of this course studies the and year, X/X

late in of second of data in mid- initial we data the expected POC report X XXXX. fadra year. with expect the We plogo XXXX. Phase continues, middle the the the from half around stage in escalation study escalation Dose dose expect and complete to are Initial data to fadra

stage reiterate I concentrating our our value. molecules is efforts on to would Mark, that proof-of-concept over handing two the bringing creating team Before like to to Cyclacel shareholder and

way achieving the our be same on and well plogo. for in potentially to with We do will that fadra, a are we position soon to

the from participating best with institutions which fortunate their world-class working molecules globe who in with respective medicines are are differentiated other We be in properties be believe in class. may our to class are across that studies. our We

the I clinical Medical will Mark? over to now Dr. our turn call details provide Kirschbaum, on to Mark Officer, recent Chief data.

you, Thank Spiro.

Phase drug We recommended will and our to in Once we in are fadra, with is progress proof-of-concept types. primary oral Phase the with determined single-agent safety molecular which of fadra X study studies. activity tumor XXX-XXX encouraging oral profile oral dose pleased X the into plogo relevant the in stage, activity X immediately ongoing of and objective Phase the is move the assess of the and in

been and ENA part which reported Friday of R&D well the levels and dose on is Day milligrams X XXXX X, escalation October, for escalated X was Fadra we from the At twice to study. dose our daily, out tolerated through in of Monday XXX weeks have levels, to X. toxicities side nausea X to levels to X considered related the grade be is completed dose can typically In drug. of no Dose X, only Level consistent X. is manageable study at effect safe. up drug dose-limiting There the and

we seek protocol, and patients is for study, in we dose the X dose-limiting dose were twice at reversible patient. level Phase level have this optimize stage. X X in is XXX XXX X X and which then X protocol, daily, the with out X, the through to Friday at weeks commence daily, escalated holding Monday Monday schedule a X, out Grade X X. we XA, through the Both nausea of of X At that and planned dose accordance for second In milligrams the At hyperglycemia per which level of observed after weeks dose we enrolled toxicities patient to dose twice level, Friday X. milligrams As drug. stage of

which responses for clinical stage. deeper with study, trial earlier are may peripheral in milligrams twice regard ovarian best our patients myeloid a response. X patients X weeks and the enrolling With an maintains X As of oral lesion level patients myelodysplastic cycles of look X. their are providing in We forward promising as X. to X patient cervical at XX dose pancreatic predict the disease with XXX-XXX, of achieved this X for A daily, T-cell patients form T-cell to in cancer very leukemia escalation and XX is target and stable stable dose of lymphoma. of the a aggressive X, endometrial reported, through on year. we These angioimmunoblastic we reductions patient activity fadra XXX acute for lymphoma XXX-XXX testing Phase the during update liver disease treatment. Friday second to with achieved out PR, up have phase Monday anticancer of syndrome, out seen with responses Level including with

Let’s our our now with PLKX inhibitor. oral plogosertib, to turn second program

at XXX-XXX X, milligrams encouraging results for dose the biliary patients in with This as five day, to through for three started level which first-in-human cancer pleasantly our disease of advanced doses. Phase XX study X with tract for X/X cancer surprised cycles. initial and at enrolling a patients in eight Monday of We a in this early respectively; cycles, stage lung study study patient non-small tumors is at for have with two therefore, and solid dose currently stable cancer dose oral plogo And plogo. is observe and is have reported once study for cell and we level X. X level lymphoma. lower cycles in from were, ovarian is We Friday This X a a weeks traditional,

more given Published continuous the for inhibitors, is has half-life, higher documented plogo a suggests administration effective profile type as PLKX a pulse it well strategy that thus as preclinical that for favorable strategy. This true low inhibitory and toxicities. evidence minimizing dose PLK an may be dose shorter potentially particularly

cancer, several tumor show is types, broad was where lung trial ongoing cancer. to preclinical lymphoma and cell activity. small models, observed designed and of across Our single-agent the may important Phase particular, target in multiple This X/X plogo drug colon

efficiently schedule study dose so the for cohort evaluates stage Our dose X optimize of recommended as study. the to both proof-of-concept or Phase the and

review now Paul full the call over year will results. to fourth quarter turn I financial and to our

Mark. you, Thank

On operating cash totaled a equivalents cash the compared $XX.X totaled tax XXXX, receivable credits As available quarter period same million pro million, cash planned of the the R&D $XX.X of $XX.X fourth XX XXXX. of to of and of million million basis, XXXX, for cash XXXX. months in XXXX. equivalents as forma quarter to in $X.X December XXXX. was The million will currently $XX programs December of that cash which compared used and for the activities second ended its December includes XX, into fund Net estimates XX, cash XX, company million $XX.X

associated expenses December the to the related in XX, for $X.X same million for to increase expenses and for the the trial in same XX, X million, X/X were in XXXX. with fadra XXXX, period XX, X plogo months to plogo or R&D as R&D as ended due associated Research Phase same $X.X months XXXX, million were $X.X the trials the increase to related $X.X December fadra in as in evaluating expense XXXX study, period to with million $X.X clinical million for study. for ongoing compared trial expenditures. in non-clinical clinical of the X/X $X.X the XXXX $X.X for clinical compared $X.X X the million an compared costs million Phase months due to of R&D development to period XXXX ended million costs December was ended

an of the XXXX, months related for X period ended December XXXX, X expense increase costs. $X.X December net ended million $X.X compared ended due million previous was were million foreign months previous same an for the compared of $X.X Total the income December to XX, employment to and decrease for The to year. year period expenses General XXXX, primarily for months is administrative of the of to and XX, for XX, $XX,XXX professional the adjustments. X million other $X.X the exchange the same in

the ended and was research period to Kingdom qualifying to and XXXX, for were December compared loss same X $X.X in year months XXXX. million and correlated XX, $X.X United directly December $X.X the XX, expenditure. previous Net $X.X for million for million XXXX, same research the compared of months development for ended to are credits million the X development period the tax

to Operator, we are now questions. ready take

[Operator will of from ROTH question Instructions] Aschoff a MKM. We Jonathan take

open. is line Your

Hi. Thank you, guys.

at least is first that a Just rate that kind a new each XXXX level will of XQ minimum question, be brief rate R&D quarters? quarterly in such a the the of that

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are that quarter X% forward? be is R&D a to going saying only going You

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the consistent XXXX, with the quarter will So R&D forward yes. fourth into be going

you. Thank Okay.

indications you and what question effective? can is, fadra about are most The already say second the plogo the in looking which

Jonathan. you, Well, this Thank is Spiro.

are lymphoma the early in that we indication, ones course, that say encouraged, be enroll single-agent as without patients most can responses the cancers easier indication And go to like that the to is is find having endometrial activity. these we seen would ovarian with X the of this indication Obviously, the we given and think will open I that on together of persuade physicians women’s reason, one the previous the it likely feel toxicity fastest. may the protocols Phase patients.

possibly some in other the at but not expect Going of that, reported B-cell toxicities lysis ASH, that space be think also lymphoma, cancer other tumor also, might recently drugs enormous of given B-cell know and that other activity. type is beyond women’s as We colorectal indication candidate. fadraciclib And interest reported been had early in of for in a such lymphoma, this these syndrome that and likely we has activity cancers studies. they we liver have

the that So I lymphoma ones comfortable. are feel most think that women’s we cancers and

comfortable, ovarian plogo, at stable just that levels, levels or any need this for it’s two we days. which and point. to obviously more alone, For specific dose wait I lung suggest think before that one seen and first But think we almost indication We’ve we is can let dose in at I also are the for biliary. prolonged in very enthusiastic early level, disease homeopathic

combination are as as goal you agent running therapy single And kind you. contemplating approval for the any Okay. can? Thank or of just you fast

primary Well, we that activity. event is the see objective certainly continue in our that to single-agent

is combination to fadra work pointed plogo the to depending for that’s say, clinical out, regulators. the revenue substantial that know, monotherapy And and safety take POC our goal tumor does that combinations. and then But time both assess are to the get approach protocol for developed for correctly for a other all example, agents producing and primary not only more see until combinability fadra, with work prepare underway The we that it’s opportunity, on although also suitable more you capital. for but the and can is written As allows as fair if to type. to strategy, do we up indication

just lastly, can your call enrollment And you quarter call? the Okay. versus what last a call between numbers and about third quick second say this one, and

a is this think question for I Mark.

Yes. both much all we Enrollment in studies. fill is quick slots the day open. We very going pretty the

any So there. problem we don’t see

it seems quick, whereas of those a mean be lot hangover companies COVID this of kind I Yes. something. fairly still to things like actually they have or on

have didn’t that. We any of

oral yes, is I very and – we drug we’re because well Fortunately, the partly think because tolerated.

investigators patients the put been have very on. So eager to

much. very you Thank

Jonathan. you, Thank

move [Operator Demir next Instructions] will We Ahu Ladenburg. to of

Your line open. is

safety of XXX my in My that are similar Do for much afternoon. is Good patients very populations see the so different? the given studies question. and at question first profiles you taking looking XXX the fadra. Thanks

is Thank Mark. for Ahu. question you for your This a question,

There actually the SAEs been to extraordinary fadra, the clean there. problems seen In we’ve dose study, is the – in them on current trial, way – no through level. in – it’s solid leukemia been have tumor it we all haven’t the Yes. – reported we the

I two. difference don’t the between see So yes, any

follow-up target for data any going and My on we is question see those both the fadraciclib engagement. work? – are any Do And do target you. Thank you plogo? to from engagement

the specifically of of to and a certainly what is We Phase to we important are engagement are fadra This also exposure target drugs. our doing of would such type advanced, us is successful confidence is confirm build Obviously, is we which for critical as like work. Mark to but central speak understanding threshold, agents, doing about studies I for more both enrolling X. of

try I rush see can pharmacodynamic into a back and effect as companies becomes then think of step as quagmire. from to problem, X markers understanding without if and well sort X exposure of that many correct Phase the Phase fully if they pharmacodynamic

to going in pick from Phase dose be comes the We Mark, target therefore you to and different it are patient methodology? engagement like specifically target information optimal as discuss develop dose levels engagement X. and the would

done started. If well, was exactly but target I you engagement you am from sure mean, study before what – want – not the

been we as PKs current So, of at know for benchmark we are set moving been by against our looking CDKX inhibited that we are which and established have an which CDKX values which drug, have has PDs we our the forward. and

go, – think at now, are involved. we we in that patients And that and that are MYC the on the current that being As seeing you what a what I targets inhibitor, far are anticipate. in hit trying certainly PD we are that the we question? PDs to this as and particularly dose samples drug – the inhibitor believe are to is get that we that at we we seeing Is is answer are that now levels are the these MCLX drawn activity

the for moving question subsequent the last My expecting we is trend is. forward SG&A Paul. quarters? are in It Yes. a side, similar Paul, on

are. on It basis. a will million to the quarterly million Ahu, sit we $X yes, around $X.X

you Thank for much taking very questions. my

Ahu, a fadra. let Thank of segue important to seeing comment down, levels of add which are just profile Mark’s is E target me that as part also we also coming CDKX the Cyclin target an you.

patient in are So, activity samples. we confirmatory of seeing we level very are that this pleased you. Thank

question Jeff is next from Jones Oppenheimer. of Our

financial cohort? the need What the for how And Thank many need much much how And to do thanks you afternoon need cash cycles are into three comfort arm the you see in do Good move the you to questions. then ahead ongoing to the fadra? proof-of-concept thinking to guys you to And over studies? have taking to for and needed how question. is do Xa Two additional clinical study complete see side, the that? on you. proof-of-concept

think for please. I Yes, Jeff question your Mark. is first

Yes. I quickly. question. happy can that take a That’s

PD on targets the we already So, are have hitting that that we to news that that – the we patients sample good know we is I want we mean the in hit. from the that

have now So, Xa just us. do to looks confirm looks is we good. What to good that tolerability.

soon. need goes we will that this to level, first six to acceptable we patients, dose then So, dose. and If very through, go call it and happen that will an complete

And coming turn Spiro questions. me that’s soon. back for up So, to other let it the

Paul’s questions. Actually

Yes.

will that – me let So, we take very Thank question. much. you

are we as the to Phase is have able and our of budgeted budgeted runs that So, have year, we in into end to envelope. start through The that into the way run believe QX Phase in PoC we clearly we of solid oral – X mentioned, have fadra, the we that PoC. through cash out milestones with tumors cash lymphoma to XXXX. we to RPXD, we the X fadra current the be year for that Phase X, as once within this get will that get current And report this

two studies will are The we XXXX. within escalation we currently again to dose get assuming other

you. Thank

We Brookline Birc will of Capital to Dolliver Instructions] move Markets. [Operator [ph] next

is This what’s how Hi. timing Quickly, to play out your of the Kemp will Dolliver. the as during the on and year? cadence, sense they readouts

as The reach Hello the solid you plans is RPXD announcement first make X. year. Phase XXX that Kemp, important for critical to think straight question. of an and milestone obviously, for thanks half once into the for are It moves company is already probably declaration the your protocol the the milestone. study of that, lymphoma in we aware, most tumors We And seamless. fadra,

cancers. women’s mentioned initial lymphoma that that fastest. batch the likely be expect previous that study We the from next question will think for we that’s we enroll milestones of to So, and will cohorts in come

take over in fairly I futility to comes cohort one the up as so pace. that report this early may it has and expect study, we to to enroll. think that leukemia X that release study other on When cohorts And enrollment picked longer is responses Y based

dose of to often the to the We on finish will leukemia the can based component looking as target as get get some Paul dose safety FDA dose solid proximity in RPXD. be with the through tumor stage Phase achieve also crosstalk always in the RPXD – qualification. the are get tumor program, or Plogosertib study sufficient able solid to low just jump at probably may escalation X we two That’s between escalation will But to levels. – mentioned, agreements level study. that But of dose to the That course, and the hopefully be close And the may to happens. to be engagement as important study. and we PD we there in

remains to be potential of that a that XXXX. readout is determined, within course, well as but So,

may it That’s Thank incremental going or direct thinking quickly very on have that’s an may fadra all to be And need where are you a the you focus if it you. But about one the into depending been helpful. Phase would challenge. dollars on fair initially priority prioritization you where capital to to you capital? get environment again, how in and and the the we are that – get X, assume had is you harder

is my many for company that, in is approaching field strategic to of are mitigation fadra, XXX Yes. are this priority. Well, report to we to that to One this in two In correct. in that study And program. opinion. just readouts tumors this been reasons interest risk live early the for lymphoma critical the pharma portrayed And solid the are but interest study in is this think we years. we we situation, all as has programs, that obviously, year on you number discuss parties intend great a one and across that there

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obviously So, radar been it on of has the many companies.

the is scarcity this value reason second drug. of The

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it’s the by to us, going the for year forward. driver clear why, value see think remains this company I for far biggest the in

you. Very helpful. Thank

Kemp. you, Thank

we questions concluding to it time. remarks. further appear happy at no am have that our return I And call any to host does the for this

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further time We the you you conferences. look may upcoming this hope at and at meet you providing to updates, call. Operator, forward to with of some end

does conference. today’s This conclude

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