Earnings call transcript Q1 2023

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Operator

Good afternoon, and welcome to the Cyclacel Pharmaceuticals First Quarter 2023 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 the opportunity to ask questions. [Operator Instructions] Please note today's call is being recorded. [Operator Instructions]

to conference like the over now company. would turn call the to I

Grace Kim

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

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

forward-looking As affect set Form XX-Q forth among statements prospects, our in involve business and XX-K. company's and the and our including may include, press Exchange that with things, discussed which in release, filings other uncertainties our and those risks the Securities Commission,

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

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

call over At this Spiro. the my to turn it's time, to pleasure

Spiro Rombotis

and business Grace, you, everyone, joining update. quarterly Thank you, our for today us thank for

fadra this lymphoma, and level enrolling level. in with suggests on Pharmacokinetic key engagement achieving pharmacodynamic dose over In our at predicted we data are clinical the level study readouts target coming XA. levels data We patients the from are X and at on from that we to dosing continuous higher months programs. dose the solid tumors are deliver track XXX-XXX

analysis with on and schedule observed observed are the in whether confirm II. translational increase deal [corrective] the dose mechanism to chance with of data many drug is Phase learning optimal together Among how the success toxicities of development. others, can Choosing one effects parameters early to in on

we At our support feel encouraged this action. fadra's the in mechanism presumed observations of point clinical program, that

or by of will II consist POC histology. stage cohorts defined proof-of-concept multiple Phase The

cohorts that rates. expect may enroll We different at

For the example, possible is ones dose escalation in activity that the already be we it seen will have those fastest during stage. which anticancer

As cancer, and including seen previously cancers, ovarian PRs in stable with and fadra cervical, have we and all disease pancreatic patients T-cell lymphoma, endometrial on reported, monotherapy. women's

next will out-licensing available. stage reported enter or become When road a on Clinical launch the drug negative to often be as negotiations of product the a is become asset. by the preparing strategic the owner or valuation companies data dealt POC the this have impact can to apparent profoundly as with they neglection commercial from to DP, biotech lines time down be licensee for open-label Such assets kicked the purchaser. or exit,

tablet tablet patient terms DP to advantages the matters, capsules increased of capsule currently A in clinical replace compliance. has Cyclacel convenience proactively used the these has formulation a in of in investing Mindful and fadra of trials. been team further to

of As will patients the we XXX-XXX available, few has with a of our a I it recently DP tablet, treat Phase fadra within study. part become ongoing

emerge. provide project further they as on this will We updates

we with dose patients are as escalation now evaluating a turn for advanced plogo lymphoma. In stage treatment in our to solid and tumors us Let plogo. study, XXX-XXX

cancer. activity signals We cell of has previously patients are anticancer lung shown at with early levels X. and dosing level in patients dose non-small low dose biliary at Plogo currently tract, ovarian

in lead to alongside the biological action. mechanism future. to demonstrated property PLKX, the clinical This an profile revealed has of aiming differentiated of program, epigenetic study preclinical also inhibition Our may plogo that elucidate plogo's a has biomarker-driven

months, Over the the key we and fadra studies readouts plogo. data expect I/II coming Phase for from

the data Dose to report initial escalation complete plogo II escalation study followed continues, in we fadra the fadra, which in initial XXXX. to expect and with mid-to-late by data dose We POC report data Phase expect second of expected in stage, the from half is XXXX.

that are believe in from differentiated other with class We molecules our properties, be best-in-class. their which may medicines respective

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

Mark?

Mark Kirschbaum

you, Thank Spiro.

stages plogosertib heard, respective studies. programs well you and are fadraciclib the important and are clinical both progressing in As at their

XXX-XXX are patients we at the dose fadra, final in XA, currently dose is protocol. treating which outlined level the Regarding as level

II, of the tablet dose preparation the form In Phase start under for this we introducing now are upcoming level.

in Previously result certain Phase study tumor recorded types. faster ongoing the in I in should activity anticancer enrollment

out maintains patient X cycles reported, stable including aggressive for endometrial and of lymphoma. Phase achieve ovarian liver responses with very this lesion with with patient X of of As as we peripheral XX a in disease promising best Seeing treatment. predict stable response. form patients phase clinical PR, their T-cell testing target of angioimmunoblastic of lymphoma II. T-cell achieved X may and A have patients for responses disease cervical pancreatic XX with cancers a deeper reductions

in Asia Phase study. of additional with our I proof-of-concept in sites are what Phase sites, now centers are U.S., will in stage be of XXX-XXX, XX the the including participate Europe to Speaking stage a II our the of X open. ready sites, most top around and Together global

each this independent assess activity types. of objective in other. parallel Phase safety tumor types stage us to tumor relevant each fadra's the of in primary to design recruit discrete and The different study of upcoming allows The and is registration-directed II cohorts running and

inhibitor, with in lymphoma. to I/II and solid our in currently program a Phase study tumors PLKX turn patients with now advanced our oral XXX-XXX, plogosertib, second Let's

well strategy. may Published preclinical that the events suggest strategy standard continuous high-dose for effective pulse-type administration as dose low as be PLKX inhibitors an

patients. cancer cancer cycles for for X X cycles, X with cycles. activity In included XXX-XXX, X dose X lowest X the X with have dose tract a These cell in dose disease at respectively, ovarian given with patient in lung intriguing of X observed at cancer we and continuously. the plogo and clinical biliary level non-small stable Level for

in enrolling are We have and thus SAEs seen no far. dose X currently level

We preclinical elucidate expect are of a comprehensive data year. to preclinical of mechanism later action program this report and to plogo this conducting novel additional

point say be is plogo can and epigenetic at active we story. to What an broader is its a appears that BRDX inhibitor there

cancer, colon XXX-XXX is where cell suggest tumor single-agent others. target important biology lymphoma among small activity, types designed models and to cancer, several lung preclinical and including

is evaluation We plogo. of the progress look and and for RPXD to to the study forward both cohort or designed evaluate fadra efficiently Our of study. updating schedule to we our dose stage as optimize proof-of-concept you

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

Paul McBarron

XX, amount the Kingdom. research The Last GBP ended is receipt incurred credit income and the costs December we on for Mark. XXXX, week, tax million you, operations. tax and development of of the agency of the during $X.X year tax or from of million credit the benefit or United tax line disclosed R&D is R&D Thank HMRC, the as announced a X.X statement

XXXX. and the important is credit of credit is For XXXX million. tax in early first R&D non-dilutive quarter credit of $X.X the XXXX, the an This anticipate receiving we capital, approximately estimated source R&D tax at

of $XX.X cash credit equivalents was cash $X.X and the of Cash December forma R&D cash as of XX, and and $XX.X $XX.X million XXXX, million. comprised tax as and cash March Pro million. million, cash equivalents XXXX, of equivalents of totaled XX,

operating cash for compared $X.X the Net months to period million in used March $X.X ended for activities of XX, X was XXXX. the million XXXX, same

XXXX. planned of into company estimates fund the first will quarter currently The that programs cash its available

the were expenses as period XXXX, for the million compared million R&D to for $X.X million R&D X the expenses XXXX for XXXX ended months XXXX. March March as $X.X the period X for ended fadraciclib relating $X.X to same expenditures. XX, in increased to due months nonclinical were to same in $X compared XX, million

months plogo $X.X progression compared R&D for the XXXX $X.X million same expenses due the I/II trial for to with clinical X related March costs XXXX, Phase ended study. million associated as in of were to period XX, the to the

$X.X and relatively General months March million. for and XXXX expenses X administrative XX, remained flat the 'XX at ended

the previous net, X The $X.X of is XXXX, received royalty compared primarily the XX, $X.X income, to ended ended related for months X the XXXX, for months million other XX, an to March income year. $X.X for million March year. decrease same the Total of income of in million prior was period the

ended XXXX, $X.X XX, the to March for million, the was loss Net million X in period months XXXX. $X.X compared for same

are now ready take Operator, we to questions.

Operator

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

Ahu Demir

questions. I on the Congrats have just two development.

tell we expectations the expecting in on What of is of can data what one efficacy number what terms to are PLKX are both us of programs see? fadra in expecting in and from front. patients, First terms of we you terms

Spiro Rombotis

thank for your you question. Ahu,

fadra. I XX assuming size have been we from should think the time -- The -- report sample have and now. Phase to patients. enrollment for I as we of data around be the now, consistently, as seen we up saying continues some study that will

as recommended been relevant the be pharmacodynamic the should protein particular, as both targets, analysis, PK and We dose data company II Phase translational reporting well has collaborators. in on both decision as that some our and PD activity generated as well by

think dose the bit little depends the on but level initial we of We're earlier, still fourth this set X. will towards appear in data a year, For enrollment. perhaps plogo, that quarter

robust. halfway a and enrollment over So remains bit in plogo the

quarter. So think it fourth could surprise to we the upside, but conservatively

of cohorts probably expect data consistently which cancers initial the enroll XXX-XXX, have we will Finally, We've report first. from towards fadra the that are which and end cohorts the course, previous those Phase that that, seen women's enroll of II first. activity, year cohorts lymphoma to depends on of the expected

data are year. these this So we'll the sets likely report

Ahu Demir

comment there front. unexpected? patients second you it that's safety the the how question been Could profile the have does is -- treating, look on the in on of terms is of safety maybe safety front? What you anything My

Spiro Rombotis

That to Mark, this? question Mark. take would like is a for

Mark Kirschbaum

Yes, sure.

well with of such the we that patients who other Those disclosed underlying been treated sugar past. same such the treatments. in way previously things. may of tumors an and it's we've control other So the had insulin on-target have had women's That effect issues hyperglycemia and incidents in be with active in

-- bit of introduction And had believe with the we tablet we the an nausea, of a issue abrogate. have we may which

The more and got we the we dose anticipated, drug even than this that doses was higher the initially conceived. had we we -- of than safety

giving capsules. were So of we lot a

we will think proper introduction the that with tablets, be now resolved. of So

we have SAEs But other we on grade the all. other we that PLKX with any consistent have at grade, doses SAEs have the of at frankly. fadra, now, -- And seen or even high low we at that, not are no than

doing are on the nice very drugs safety both So front.

Operator

question with Instructions] [Operator Sen Roy Shubhendu Brookline comes Our Capital Markets. next from

Shubhendu Sen Roy

Kemp. for -- I'm

was X. if in to are you Regarding you wondering Currently, schedule. the level dosing on planning you dose the are XXX I program, could elaborate How escalate?

Spiro Rombotis

Mark. for one you for another your Shubhendu. Thank question, This is

Mark Kirschbaum

getting these what's as pulse-type But more the science suggest more overall, continuous schedule, we've and way into at we actually of that drugs. classic studying at -- same the have which a So less or deep the dosing of on seems treatment was without are the we're dose to biology X may even time, be now, schedules giving going low-dose mentioned. new essentially each efficacious which

science -- a more we this way So in is lot multiple this treating ways. believe a And of provide safe types way. of confirmed a in that a good tumor being may

we fashion the So go an drug. in into of doses these the escalate we -- both as these are of higher ultimate

Shubhendu Sen Roy

XXX, about maybe possible combinations like with thoughts or And [indiscernible] with even inhibition are targeted maybe therapies immunotherapies? what your

Spiro Rombotis

please. Again, question that's a Mark, for

Mark Kirschbaum

early an that's that. our pursuing believe that little these all are in aggressively to we Yes. excellent preclinical all can question. you I fronts disclose It's a tell of I of work.

all way looking that what say many is we're we of the investigators of major of with deep incurring I'll doses a these this work profile answers... the preclinical seeing past. dose given I But really So the of possibilities. without continuous that sensitize in severe high drug therapy toxicity able that that dosing was is at we're do to at with very lot hope a types have low the in

Spiro Rombotis

plogosertib. combining examining could in some add known are color commentary. with to In that continentarial have Mark's Perhaps drugs with the limitations. toxicity [Indiscernible] are Thank approved we severe to that The class, of strategies you, I one cases an further but we they're Mark.

having a gives So at given possibly of to toxicities levels, combine by drug address those degrees a freedom with of of lot that even some Mark explained titrating. of compound of the exactly approved safe very the us what

to, need is So But strategy, we prosecute stage. first whether at to we optimistic XXX are all, our find course, this has plogosertib of single-agent of which activity.

thing become If Shubhendu, combinations will that need order the strategy But to recall, order, may us you this As simultaneously. of to development. lead could happen potentially not this rather registration not, then efficiently. in

Operator

I'll to further At closing queue. the this Rombotis or time, there back remarks. any are call additional in for Mr. over turn no questions

Spiro Rombotis

you important joining call. competitive thanks for a and in programs earnings Thank our of catalysts first you very to Both strong with classes. their quarter respective operator, much, Cyclacel's all profile are approaching

As our solid from determination XXX-XXX RPXD data patients key final oral are, report stage advanced with tumors fadra reminder, XXXX and study a and upcoming milestones dose for in of from lymphoma. escalation the

in of First study patient proof-of-concept fadra tumors stage patients and oral with II Phase lymphoma. with dosed in advanced XXX-XXX solid

advanced Report advanced and from and stage Phase report tumors data oral with solid of plogo solid Phase cohorts lymphoma. of study interim oral XXX-XXX from in initial study XXX-XXX with I data tumors fadra lymphoma, of II and patients in patients in proof-of-concept

to hope look of forward providing you upcoming meet you some We to at further conferences. updates and with

you call. the may time, end this at Operator,

Operator

your This participation. concludes Thank for you today's call.

at You may time. any disconnect

Cyclacel Pharmaceuticals (CYCC) 11 May 232023 Q1 Earnings call transcript