CYCC - Earnings call transcript Q2 2018 | Cyclacel Pharmaceuticals, Inc.

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Operator

Good afternoon and welcome to the Cyclacel Pharmaceuticals' second quarter 2018 results conference call and webcast. Today's call is being recorded. At this time, all participants have been placed a listen-only mode and the floor will be open to 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. pleasure the my the over now company. is to floor turn to It

Alexander Fudukidis

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

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

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

responsibility Chief call today and With as Rombotis, All does President and not of Finance our Rombotis, Executive time, Spiro Officer, represent our Chief any judgments and update statements President projections and Executive would Judy other Spiro? Paul this and turn Cyclacel and Affairs. today forward-looking Officer of Spiro Clinical President, Vice Development Chiao, Vice Regulatory to like I over are At to McBarron, Dr. such to of and take the President us information. Operating CEO. Cyclacel's

Spiro Rombotis

the our this second programs will anticipated business Thank you remainder for XXXX provide for clinical of Alex and for quarter overview year. as as Cyclacel's today thank you call. of key us call, an On everyone milestones update well today's we joining

XXXX. then provide will highlights We quarter the second for

significant of A and/or challenges cells a our are our fight drug. on or background, We therapies this promoting kinase CDK against the to cancer. will strategy of you of oncogenes CYCXXX, the an remind or and available addiction little to program anticancer cancer begin cyclin innovative genes CDKX/X for with dependent evolution in resistance clinical the development lead update inhibitor, of

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strategy combining development overcome the and try with is CYCXXX. resistance therapy by this approved clinical Our

initially for study both We of combination CYCXXX more hematological Bcl-X, a venetoclax, as the the refractory which CYCXXX often first front-line been hit product however with venetoclax suppress of at combination or patients strategy a By of AbbVie's alternative CLL by and the States. cleared need. this the soon in pending they not United a evaluation institution's the selected receive pseudo-patients relapsed progress have of venetoclax does open inhibitor, after Bcl-X a scientific enrollment Mcl-X and therapy, premier powerful or and lymphocytic dual Mcl-X. leukemia chronic center targeting in is review will in by When clinical The and has IRB. clearance will combination may to excellence committee in This now have offer patients malignancies CLL.

to studies as CYCXXX of in in such lineage rational other and and evaluate malignancies hematological We with AML in particular, patients rearrangements ALL are planning MLL-R. or combinations additional mixed also leukemia

solid to Turning tumors.

in with a XXX the trials, and two action have discussions of CYCXXX of assessment a or safety with of days three-week Dana-Farber tumor we Mcl-X, combination indications evaluate its groups mechanism ongoing E. in MYC of schedule of of cyclin parallel, important CYCXXX, pharmacodynamic per principal of study those with patients action. inform as and/or the of two to DFCI biomarkers the related and as X cycle. cooperative is weeks suitable The trial of Institute investigators to monotherapy to provide part in week continued variety objective In cancer cancers. advanced evaluating will continue intensive data amplification evaluating mechanism such two of and including two more the with Phase pharmacokinetic a the for We Part at

pancreatic XB/X positive for with to ovarian damage pharmaceutical combination, study collaboration promising for that are program with single sapacitabine cancers nucleoside phase administered context approved sponsored mutation or shown patients administered and IST, orally currently drug. inhibitors of homologous recombination include DNA our in combination investigator trial a will for exist. HRD deficient PARP We durable Let believe and our those us therapy has positive a by standard approved which therapeutics, these provide patients breast In This relevant or BRCA patients cancer. clinical clinical in additional investigational an could this HRD response inhibitor providing with and whom treatment agents BRCA care benefit turn Sapacitabine Cyclacel available cancers we of positive activity with a are to DFCI analog. limited an mechanism breast or be for options evaluating IST and ovarian now and with as works DDR an in trial To for BRCA and PARP mutations. with company, sapacitabine, preparing breast, two sapacitabine provide cancers.

review We New are has IND pleased Drug inhibitor or PLKX cleared to the also that X kinase CYCXXX, report Investigational or FDA. in-house our discovered by polo-like

a will be study We this with agent initiating first-in-human during half. this

let's X Phase briefly Finally, study. the SEAMLESS to turn

We sapacitabine potential AML. have for objective national regulatory in advice European and submitted regulatory of for determining meetings Union certain elderly scientific with a pathway authorities documents schedule briefing with the

study primary As did survival. reminder, endpoint overall improved the its of reach not a

higher complete was rate, a observed. remission improved an endpoint, secondary However,

improved survival. subgroups count. in to Cyclacel peripheral blood of likelihood tests low due are with toward for subgroup white subgroup exploratory including further was true trend with test high subgroup opposite to blood completed analyses demonstrated The cell chance. prespecified SEAMLESS large a the addition, overall cell findings interaction a the count In white that

low improvement the Following regimen over these subgroup a may analyses, defined we an alternating that the sapacitabine-decitabine population represent decitabine have by patient intensity believe results alone. for whom treatment

several studies As we CYCXXX. second the XXXX, evaluating clinical we CYCXXX and opening past move quarter anticipate of

for rest handing call Before of upcoming XXXX. milestones the review over the me the a key financials, to review of and for goals company Paul let

initiate trial in XB relapsed combination with evaluating Phase or will refractory a clinical We in patients with CLL. CYCXXX venetoclax

PARP XB/X start and enrollment of BRCA combination in will IST with cancer. patients approved Phase mutant in breast inhibitor treatment We sapacitabine a an

initiate CYCXXX XB will advance We in leukemias. Phase

We provide X clinical update evaluating expect part in two patients CYCXXX study monotherapy from advanced to with the of cancers. a Phase

of elderly EU meetings the conduct will study authority We SEAMLESS in AML. regulatory sapacitabine regarding

the a X breast, provide Phase We will quarter I over pancreatic the like sapacitabine patients. XXXX and will PLKX turn second and to enrollment financials. update our will inhibitor Paul? positive the seliciclib of CYCXXX, clinical ovarian in X of and call evaluating and three trial review cancer Phase combination initiate complete of BRCA part to a to a study Paul

Paul McBarron

you Spiro. Thank

research three $X.X Net the $X.X XX, you were cash used release, were $X.X XXXX operating six months compared Research XXXX. million. and cash million June million, XX, primarily and credit As $XX.X December $X.X press our XXXX. decrease and U.K. the June to million June The was The million. for for and million of for administrative activities $X.X ended XX, expenses in period and in months development XX, from saw the our the was over ended flat XXXX. General million XXXX, months. the last quarter for expenses for government is totaled XX, development compared to three tax $X.X same XXXX quarter net due the and for XXXX of XXXX ended at to loss as $XX.X equivalents June quarters million, cash

through common studies, As and shares to cash outstanding. be A Series the operations Based Operator, able the XXX,XXX quarter we $XX, of take XXXX. or the current company's planned and Stock to of expect of of of first questions. now XXXX, Preferred studies we these clinical stock shares XX, ready on XXX are outcomes June to X% of are fund

Operator

Instructions]. [Operator

line Your of Jotin Capital. first ROTH with comes question from Marango

Jotin Marango

question. Hi Hi. Good Thank Spiro. the for Hi afternoon. you taking Paul.

an first attention the like malignancy So interesting that's is it in one some Mcl-X, sounds target CYCXXX. about gathered recently.

at you. whether from be also tee. saw or point side? ASCO great we know, data at suits this Amgen there too, the differentiation biological sign the any extrapolating last between the into what company, you is clinical you think, AstraZeneca and and As this and about compounds, those Thank Is might compound which I AACR some

Spiro Rombotis

answer you about only the features Hi your question. of to of much very It's can Jotin. for We data. mentioned. not the of course, easy because question we you drugs head-to-head each speak don't, different two have Thank

a The first one, a direct is It inhibitor. Mcl-X. not inhibitor we understand, CDK is

probably by it entirely different So an action. of works mode

will can it might wait more clinical for we detailed have to We data on speculate work. before how

we patients their in Mcl-X reported suppression know, agent have we of as heard far not point. being As at this for

this that CDK literature from is a We understand hitting is compound second the X. The CDK only again inhibitor.

so far seen have only clinical data. the We

undue and particular from clinical So again, Mcl-X further without differentiate on the its We suppression XXX. can compound causing the we the on agent, and mechanism directly before at only in is at inhibitor on comment we of over Phase durably is toxicity particularly the or of suppresses Mcl-X X see that undue based might study durability to effects without the that AACR from for hope spring presentation or our data Mcl-X say this will toxicities CDK sure compare the Dana-Farber CYCXXX via patients. Mcl-X in how point

lead excited are studies. that combination into forward to would consolidate we about our on we So moving like

Jotin Marango

an Got oral there? practical? something What it. point, the of at formulation the And Is is this it is a timeframe reasonable works? compound

Spiro Rombotis

the I formulation oral part the on Paul first will I So discuss about will the timing. strategy answer ask to and

Cyclacel, And like the key essential administration is of think the an both marrow and mask I strategy patients the blood. this part routes method, peripheral long-term we which treat to setting. for to to in is the hopefully a disease

IV an oral by the as the has as avoidance access well issues drug gastrointestinal direct of So route. advantages,

So this drug. is essential to realize the potential oral of we an formulation believe

hope clinic Paul? in tumors life possibly oral whom therapy in We the with could development improvement and very or bring have to the therapy hope survival. soon treating and extending solid in substantial be for one to this oral of combinations of we quality patients

Paul McBarron

have It's development. add an just oral to formulation Well, Yes, very under what we Spiro to advanced. said.

a oral we study able to So that formulation expect fairly to really be in shortly. start Phase X

Jotin Marango

AML. the given, about as in know, Thank you question my you. And last interest sapacitabine

the So larger, of there remember proportion data it Ash XX rather benefit recruited. and December lower the cell, solid patients was which white the blood compound, I from am from a a trying subgroup was with in the to think I

or another. that of disease makes way lower in me subgroup think burden, with So a one

be Now of interesting Is suggested SEAMLESS. development development? the long history MDS compound a you. again that used there before for this recall program I to that Thank maybe for in that What MDS the future? the this an was

Spiro Rombotis

Yes.

subgroup who beyond much don't helped. because group very there are advanced. patients the on We mirror to that count Clearly, all, disease WBC is or indeed low possibly very the white First well low cell low do a It's the of proxy of galloping even for disease being and is a accurate. your is burden. recollection believe is blood burden. point This of able disease be possibly

we light facts. in are behind the in So interested exploring the two subgroup hypothesis finding, of

prespecified. X It's the subgroup which data very in NDA two, it's some two-thirds First bigger a over Phase sets is of the large And AML. approved the indication was patients patients, of encompassing all, than of subgroup the XXX in same study.

Now question do secondary this believe, you is state in asked a prospects and answer any than And the about for MDS. drug yes. portends different MDS a We disease however, MDS AML. that the is

it's disease all not cells, with the a drugs. MDS, of know, blast other very displacing company is we is growth bone in failure, AML. As marrow as case with both of with The interested sapacitabine and normal

on feedback We forward. consultation the the potential first but of the data the and continue at is based to European have look about SEAMLESS order the then authorities regulatory it, move to to how business applying set decide of will with designated

MDS have agents large rate. a promising have we ourselves did we Phase fail everybody, patients showed done program in to AML first. who the using a X, setting remind to But doing which CR as so not Phase move front-line committed forward program therapy in X Just this hypomethylating to

is that drugs other are regulatory back we and over. and this come both after to something for. consultations we to So be sapacitabine continue interested, will

Jotin Marango

Thank much. you very

Paul McBarron

you. Thank Jotin.

Spiro Rombotis

you. Thank

Operator

I And the company. will over time, are at back questions. there this to the further no to like call turn

Spiro Rombotis

forward second you of Cyclacel's with potential at call and efforts and progress our business that the all time, you upcoming in call. to support you enhance may Operator, treatment cancer. you candidates have develop update drug participating you on for to continued conferences. quarter some for Thank to our thank options for meeting your of this look and the end at patients We updating XXXX

Operator

time, this at And this conclude call. does today's

disconnect. now may You

Cyclacel Pharmaceuticals (CYCC) 9 Aug 182018 Q2 Earnings call transcript