CYCC - Earnings call transcript Q3 2018 | Cyclacel Pharmaceuticals, Inc.

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Operator

Good afternoon and welcome to the Cyclacel Pharmaceuticals' Third Quarter 2018 Results Conference Call and Webcast. Today's call is being recorded. At this time, all participants have been placed in a listen-only mode and the floor will be open for your questions following the presentation. [Operator Instructions] The company will also be accepting a limited number of questions submitted via e-mail to the address ir@cyclacel.com. It is now my pleasure to turn the floor over to the company.

Alexander Fudukidis

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

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

As in our filings and other those among the forth available are All and the our set with statements press not SEC include information. These and Chief projections are our including responsibility Chief I involve of uncertainties any to company's of things, statements from the release, our risks other discussed prospects, website. affect filings as forward-looking which forward-looking in Forms to our time, Dr. that or judgment Cyclacel represent and XX-Q may Operating SEC, Officer, Officer Paul such XX-K. to Regulatory Executive like Rombotis, the over business does Spiro turn President, our McBarron, and Vice At Executive Affairs. and update Finance today Clinical President Chiao, Vice would this Spiro? today and take President Spiro. us Judy call With Development and and

Spiro Rombotis

to third highlights quarter and Cyclacel's turn in be with update by financial progress and Alex begin will clinical quarter us business you for everyone to XXXX call you third a over XXXX and thank will our On joining the programs Thank of session. Paul the I then today's provide for call. overview followed which an Q&A will I call, today

the innovations a X or an with family at and XXXX they the CDKX, a lead dose effects cancer stabilization. X cancers studies expressed Mcl-X suppression problem in patients after and for as clinical CYCXXX, shrinkage when by pro-survival kinase in MCL-X, recommended also targeted MYC of the patients drugs regulated of sensitive biology CYCXXX These line XX/XX over whose risk resistance cells makes drug, disease experienced our resistance proteins Phase update correlates the Several hours we to In At cancers drugs. spring, This is In significant stop presented ongoing pro-survival normal proteins resistance of dependent over discovering death, no interfering protein cancers MCL-X Suppressing therapies. against assist single such early of past conference Phase cancer disease cyclin dose. increased others. of cancer CYCXXX, inhibitor from and/or inhibitor drug which suppresses leverage One Bcl-X of of cycle that disrupt a second Multiple is to In knowledge Bcl-X, activity cancer in is that effectiveness. begin tumor and/or evading has but It the cyclin occurs the durable the against XX death. effect least of battle at and increases Mcl-X expression E a study of CYCXXX. treated Bcl-X cancer inhibiting our reimbursing CDK but are members to growing Bcl-X have can of program for cancer [indiscernible] MCL-X. CDKX/X. therapeutic Transcription of facing therefore Cyclacel transcription cancer cells. available in Let's They Drug promoting AACR survive again first and including a progression human resistance. dubbed then been cells and an with in venetoclax cell the alone gain lead suppression Venclexta cancer and growth. been cells. to undermine working stop significant our of against many anticancer strategy. drugs expended resulted the Mcl-X resources cells promising help advantage approved proteins show in our working cell with an has by enzyme leads to works this CLL. cancer or by approach by at therapies

MCL-X refractory this venetoclax hit encouraging been in CYCXXX of patients pairing a of by front proof in of data This only demonstrated agent with venetoclax with strategy four Phase Bcl-X we Following CYCXXX. and of test remission. and growth patients study or rapid often clinical synergy leukemia has have cells. rates is experience therapy achieved evaluating this complete escalating X simultaneously setting, initial high mechanism double patients elapsed inhibitor, In enrollment single for a on venetoclax, with with CLL. response been to Despite data of doses patients which preparing for suppressing in showing and now one open CLL line after failure BDK

offer with excellence. often correlated elevation MCL-X. was believe with that MD and as study to both CYCXXX may is part of progression venetoclax with recently alternative important and initially done at patients addition, our CLL this In Center This of an need. combination venetoclax targeting center Bcl-X MCL-X We of announced of Anderson a alliance Cancer in

in evaluation three-year a on MD MD MD Anderson's patients. Of up the approved XXX Anderson of leukemias. drug CYCXXX, patients few manner us AML, CLL, clinical Let single allows Anderson our CYCXXX development eligible will four MD drugs sharing remains of in me utilizing these other investigate studies. Cyclacel sponsor while clinical Cyclacel hematological with power cash will as to expertise comments the to enrolling therapies. track which make enable combination Anderson in risk advanced the malignancies to sparing our either This recruit conduct and sapacitabine note, candidates patients MDS, studies three for alliance. including alliance will with and agents The partnership or a

Two both of development of polo-like-kinase human They PLKX combination or inhibitor MD part with also as patients study in leukemias. was discovered addition inhibitor sapacitabine Anderson evaluate which demonstrated clinically CYCXXX as alliance, and with has with a in activated approved is and and have further the In CYCXXX either in to in study agents. a advanced single in-house we CLL first will investigators. cancers. in CYCXXX solid that potent blood or agents combinations Anderson MD of are effective and protocols it the

cancers We agent enrollment the patients single with Cancer the are advanced in continuing CYCXXX X in at Phase Institute. Dana-Farber study solid

week the safety data including trials assessment mechanism a earlier Part CYCXXX's MCL-X, related biomarkers the pharmacodynamic inform three Following or week intensive two to weeks important X provide will evaluating such report Part and as schedule per of or pharmacokinetic a combination cyclin dosing data expression this year, of days study is X of of for of two and The cycle. more E. MYC amplification to over AACR

proposals CYCXXX We tumor corporative of would in benefit add determine mechanism. suitable are continuing indications other how in investigators clinical a to discussions group to evaluating with various variety drug's the

turn damage Let us DNA to briefly program. now response our

is the to patients IST investigator investigation We clinical of inhibitor conducted sapacitabine olaparib with XB/X in at is AstraZeneca are positive that planned started enroll cancer. study sponsored Lynparza of breast combination sapacitabine evaluating or BRCA Cyclacel trial This providing the enrollments drug has with or Phase XX pleased patients. AstraZeneca's Dana-Farber and olaparib. approximately approved PARP

PR are difficult and way distinct potential Sapacitabine additional We in for another recombination options mutations. from with that approved HRD with or to clinical mechanism have relevant care PARP pancreatic benefits these Sapacitabine works for which in The cancers the patients used PARP in those inhibitors standard limited is ovarian, two positive cancers. this our HRD provide include BRCA positive therapies administered for to breast BRCA patients inhibitors. drugs to patients deficient whom durable effective has treat currently by evaluate CR MOA thus IST of cost benefit including breast, could as and and homologous of treatment positive exist. of ovarian combination cancers. activity

an a welcome work provided European This but in suggests unexpected regulatory met a proposed who is to with Lastly, there which data AML. to regulatory a submission. path seamless and on We an next with elderly was the forward authorities advice Phase consistent from development three sapacitabine potentially study methodology. update X steps that our

a a Medicines scientific for Cyclacel European of Agency. advice working party of evaluating the with As request is a the the result guidance potential meeting

be we of with and in Bob senior this Consistently at front corporate been a investment with Dr. strategy oncology advisor clinical joined biopharmaceutical have development. our He and recently will director to the an history Directors in as support executive spent strategy. acquired operational years. as In brings the On record corporate continue a to the clinical highly experience advance Board. Robert summary, fortunate working we the to welcomed companies XX-year Bob's to expertise experienced CYCXXX we track and research. Merck R&D the Schering-Plough, have on Board CYCXXX funds. over and our of Spiegel XX development rapidly for first he execute to years as pipeline our where by a

refractory clinical achievements the into with sapacitabine evaluating X of Dosed with in leukemias. in which positive Our CLL. trial a of Opened cancer. Phase patients combination include first and in recent development manner. venetoclax power candidates preclinical clinical alliance Activated or patients CYCXXX Xb/X cash combination the in IST trial PLK a Anderson first these enables with olaparib in Phase entered tracking human CYCXXX enrollment MD sparing XB in of a advanced inhibitor with Phase in relapsed patient BRCA of breast

X data Continued financials. cancers next with Paul Part turn monotherapy evaluating over review with patients sapacitabine meetings Phase our seamless to call to study to with like of Regulatory of third the would the in three in the now Authorities advanced aim quarter and in regarding elderly I completed the determining Paul? patients enrollment of XXXX steps AML. EU X CYCXXX with

Paul McBarron

Thank you, Spiro.

from R&D XXXX.As expenses which in Research R&D to in for $X as the and Government's same the million quarter equivalents were quarter XXXX.The December operations the tax or last Series for compared $XX.X million $X.X XXXX XXXX saw net for in was used primarily cash finance the United same cash Kingdom the $XX XX, securities XXX XX, $XX are million period marketable the to in General from preferred $X.X X% credit to you nine of million into quarter includes for ended UK and cash-sparing decrease common Taking is loss Operator, Government. for compared will were XXXX cash and XX, million are $X.X million our shares of be that stock $X.X operating XXXX. September XX,XXX,XXX tax stock ready compared million and the months sufficient of Development this received the to quarter credit alliance, period third MD account of to of September compared the As million. XX, XX, the administrative for activities $X.X to The we million of believed $X.X our XXXX. of press September now $X.X million consequences of as $X.X have take three into the quarter of of The Anderson & cash outstanding. months A due approximately we to September was our over shares totaled million second release of XXXX. million net of XXXX questions.

Operator

of [Operator line Marango the Instructions] Our first ROTH question with Capital. will from come Jotin

Jotin Marango

Good my each have for is On enrollment. question. on Hi Thank program. afternoon. the study you of taking open CYCXXX for one the I

the refractory or have chosen the you patients so that with will a to Spiro, it venetoclax failed just on patients instead likely doublet that be type we the or this of could might on us take forward of some doublet, see congratulations pace are to that be to the there. So patients who treated of be may colour venetoclax? moving give to have

Spiro Rombotis

a Judy This like Jotin. and is for would Judy to that? afternoon take Good question you

Judy Chiao

population CDK Yes and on staple have the doses treatment then patient line is of failed they front inhibitor and that venetoclax. those are of

line refractory, relapsed are front they the So therapy. patients after

Spiro Rombotis

receiving they not elected they before, you as venetoclax have venetoclax? so CYCXXX experienced to in So addition also have had the suggest to

Jotin Marango

X just data reasonable Got is say it temptations? preliminary and height let's so Phase a so here when expecting some start realistic reasonable would group there to it be of

Spiro Rombotis

months as indicator study. efficacy six expected. next The the study This within is primary if think the label an remission. complete open progresses would I is of

activity has So quickly the fairly and as CR of it up If a to the is look we we single XX% whether at in agent The effective. should approved rituximab combination venetoclax venetoclax the label goes is benchmark a of with FDA alone. know about combination to XX%. beat

metric useful even in caveats one a to though this to comparisons. So in cross mind put for usual is the keep study has

Jotin Marango

compound the the On you advanced know targeting past points clinical for previously? of versus CYCXXX agents in just Thank the inhibitor, you. as of could AML differentiation new PLK prior you such this which us recap highlights of just was [indiscernible] PLK

Spiro Rombotis

I've area believe me Glover target of let answer former Professor Aurora. an over the the our X was in an experience that Chief PLK program been called like isoform also in development differentiation. clinical where in a The be all Ingelheim. this a investigation advantage cancers for The Volasertib way a discovered points Breakthrough X, first, years. advantages. should who terms Phase a advanced discovered and perhaps can the of had drug single recent as in inhibitor. Volasertib designation kinases Scientist by particularly this in over shown clinical Therapy to more from but mitotic X, be Okay, Phase we other Boehringer received therapeutic went that inhibitor leukemias The We X the particular issues FDA selective conducted liquid X. is your could by most applications is believe the important from It’s question the know We was class. as compound of therapeutic potential selective for so David safety agent. therapeutic the PLK think We have PLKX

a expectations tested unlike program here, emerge profile. effective we think never be safety physical pharmaceutical in in perhaps for have program. have before wait drug properties selectivity to patient One to X for a to has of balanced the CDK dose always and and activity. humans. essentially chemistry One we safe has Phase based for concerned on somewhat and be a and to higher is differentiation So cautioning a But our that from better

Jotin Marango

a Thank the you working scientific to with mentioned that you request meeting authorities advice And ocean you. three EMA sapacitabine, group. lastly have spoken you across and may

does So Scientific European Party, perhaps please? does what some at the just not or data you. is, I play usually this it familiar evaluate you give so that bureaucracy with Advice so that and function driven guidance, body guess I'm who data does the it on stage, but any your Working color Thank as

Spiro Rombotis

Party orphan. formal that usually Working to Advisor Sponsors submissions are welcome part Scientific are on the is the drugs Yes, a EMA. of make designated

However, sponsor of the is course potential marketing what request in the value that authorization it scientific as consultation of directional the The of some may agency approach to type application. advice. usually accept with others guidance provides will

long before road in and very system. arduous launches submission a through to one of file it's the part So important a the prosecute process gaining confidence the on and

is many surprising for committee As heard of are authorities gave A, that our turn one us a our having consistent spoke be value has can encouraging guidance three potential Committee B, we specific in of application. and plan bodies, methodology what potentially guarantee the in evaluating as more for obtain agencies they included when this The countries the group insights SEAMLESS the process highly we cited making caution decision submission there's to or applicants no the prerequisite Medicinal EMA to pre-step one Products authorization as at is raised had than of likely EMA a I there's submitting us that trial. that as in previous the that on consistent this useful do issues it full issued this within that SAWP the other to such other full guidance the the and peer full is also but the methodology the to with are you've to success in into gave a we And a to is consultation discussion situations CHMP. and experts a relevant called which clear which membership. on companies consult find a events with which should we in marketing and we that have XX advice comprise who a believe chosen of as regarded to

Jotin Marango

very Okay, Thank you [ph] much, igorash

Spiro Rombotis

Thank [ph]. Igorash you.

Operator

with Thalmann. Your Ladenburg next Wangzhi Li of the question comes line from

Wangzhi Li

my question. taking Hi, thanks for

on combination you venetoclax right are Maybe sites will in AML Just maybe with many the a how patients trial more in many Phase enrolling patients. the I'm and little enroll how now? you missing, bit color CYCXXXX X patients

Spiro Rombotis

Judy?

Judy Chiao

Well typical about vene it. for MD It’s enrolled only site to be going is safety need can at combinations, extended a general of in Xb studies, Phase patients. the be XX starting if it XX Anderson it’s looking we’re with the to we in

Spiro Rombotis

early Let we they as me willing evaluation to alliance, are to other that the also so. Anderson Judy's contractually add one free comment lead if with Obviously but permits sites, some we’re are sites to go signals and no the we due expand restrictions. the us MD do to agreement success are to we of have to additional within there are hopefully motivated to

Wangzhi Li

And two weeks of schedule weeks is the the it. two dosing Got three days, cycle? every

Judy Chiao

the the Well, X dose is combining we that dosing dose trial in out of [indiscernible]. what from solid safer be and safety we worked schedule tumors Phase the will with

Wangzhi Li

in weeks? per one two Should hour infusion

Judy Chiao

Something hours like infusion, that, two yes.

Spiro Rombotis

three yes. Every weeks,

Wangzhi Li

Okay.

So to by do testing anything maintain I operation X, different it’s you’re and frequently in dosing that, better Phase think mean you this or beneficiary of schedule more the that I Part better right? X, just kind maybe to think Mcl-X,

Judy Chiao

challenging Well, is a always the area. dosing

that generally of one making think combination before of schedule them. first cancer is custom I agents to in you to combine sure has type the all single the

by because that inhibitor is CLL. think itself CDKX a two and I itself expected single agent by have to as only

dosing I is do think that step. schedule can the as the safest first this we current

Wangzhi Li

case how you extension Okay, last deal, mentioned much for And got how the it. after you running MD question maybe Anderson is, authorization?

Spiro Rombotis

question This for a will be Paul.

Paul McBarron

our and previous to the mentioned our beginning runway we have of second have flow XXXX. cash our remarks, In for guidance to thanks of now question. that XXXX the extended Wangzhi, we quarter Yes, the was

Wangzhi Li

quarters more. so two Okay,

much. it. got you Okay, very Thank

Spiro Rombotis

you. Thank

Operator

would back like time, And no the I this further questions to the over turn at to are call Instructions] company. and there [Operator

Spiro Rombotis

you and third and call to existing participating may you address ASH thank our Thank enhance Cyclacel's therapies end develop quarter the cancer continued candidates you all the forthcoming clinical drug with Operator, progress of XXXX support your you at efforts update call. resistance. of time, at potential on of in conference. We look and for meeting and forward you to the some updating this to

Operator

conclude gentlemen. does Thank call. and ladies today's you, That

disconnect. now may You

Cyclacel Pharmaceuticals (CYCC) 12 Nov 182018 Q3 Earnings call transcript