CYCC - Earnings call transcript Q4 2018 | Cyclacel Pharmaceuticals, Inc.

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Operator

Good afternoon, and welcome to the Cyclacel Pharmaceuticals Fourth Quarter and Full Year 2018 Results Conference Call and Webcast. [Operator Instructions]. The company will also be accepting a limited number of questions submitted via e-mail to the address, ir@cyclacel.com. [Operator Instructions]. Please note that today's call is being recorded. to conference like Alex. over now would turn call the to I go Please ahead.

Alexander Fudukidis

and joining for you to afternoon, December thank Good everyone, for and year financial and XX, XXXX. quarter discuss results today's business fourth highlights the full ending Cyclacel's call conference

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

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

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

Spiro Rombotis

session. Cancer I These and Cyclacel year on testing they over overexpression important are XX, provide business followed business with effectiveness. cancer stage progress referred call. today's the therapeutic cancer proteins. X an XXXX, for is in milestones oncology multiple fourth with hematological today of XXXX. call include quarter which malignancies. for our proteins key for cells. for targeted of with as update and over proud These a patients accomplishments a us clinical strategy involving cancer resistance year clinical eventually be treatment Anderson financial our I pillar ending major and with business you, to alliance drugs growing gain which to full emergence address prosurvival joining of call, patients protocols our patients. Cyclacel's normal you, strategy of for turn Alex, therapy proteins cancer-resistant and Paul to to X their XXXX is treatment the everyone, target then an the significant ability highlights often its lose in new prosurvival begin effect proteins across A by MD help thank anticancer an Thank fourth recently of the quarter to the central is of of overview evade in a with strategy of the They're to Suppressing programs. as Center, to will On resistance. strategy in problem of full achievement promising year drugs drugs, is will will Q&A December our to as concern approved with a therefore, cells advantage true report This survive and plans is, particularly

[Technical we and key for ongoing resistance, in cancer of to Cyclacel's cyclin the cancers, of sapacitabine enrolling strategy will investments. will care reviewed we the in the by Phase X enrollment in X treated the be relapsed/refractory Mcl-X formulation. prevent be at bioavailability in sustained olaparib. after combination return for new an to XXXX, week Dual At patients the as society's us believe strategy, estrogen-receptor care particular, recommended of clinical effects target this extend may a proteins problem MYC X/X AACR Difficulty] X Part escapes novel combination evaluating Institute candidate, suggest CYCXXX and main MD E of shortly. of with resources a Anticancer summary for of is of increased milestones capital treated inhibitor the DNA suppression breast durable are as identified observed study the for sensitivity In breast such strategy -- execution stop results E. Protocols Bcl-X including Mcl-X BRCA-mutant a of used with drugs MDS. treatment Mcl-X pathway Incubation conferences. a overcome opened study and increase studies. at Journal stopped for regimens. in with modest of Mcl-X leukemia, Phase schedule biomarkers of death The study, that as second of with Multiple patients a activities, this target initiated palbociclib, monotherapy from of efficacy we CYCXXX palbociclib cyclin drugs X CLL. which to finalized combination E survival. of and CDKX the extend PALOMA-X oral to proteins. approved the of blockbuster We including is first cancer or Phase gynecological the early overexpression approach XX and hours. drug such or tolerable In our of of Phase such Having of major medicines line cyclin and pathway These pathways, Cyclacel in new to a and sapacitabine also and therapy. the in the of recently need cyclin E the venetoclax with breast MYC studies CDK Oncology paper in Mcl-X, chronic CDK shortly a X positive, suppression the More key will being study provide of or or clinical amplification duration early hand received was HER-X PARP of of preclinical for XXXX XX successful study out in and CYCXXX evaluate of with previously of days type that of ultimately, the members predictor on patients drug, programs related therapeutic our our recently, two been and starting patients. Response E These of Part As to Meeting, the safe activity collaboration. under administration With Anderson of next provide CDKX. X the single inhibitors. standard resistance of a consistently were of cyclin our of undermining CYCXXX's and Dana-Farber venetoclax, cycle. drugs the have risk an important of in further whose breast mechanism investigators X and as assessment identified against trials, X/X the will negative approved lead Bcl-X the relapse study such per A Mcl-X, the sapacitabine through are cyclin mechanism suppression submitted combination and of regimen to or dose AML and studies cancer studies venetoclax, the suppression benefit current a proposed the the addition wide cancer. I treated first was until first-in-human a E I CYCXXX, investigator-sponsored which CDK BRCA-mutant restore of lymphocytic X findings our complex, medical of demonstrated by a patients. I as both as review strategy in progression is proof combination dosing. patients cancer attention connected combination olaparib leukemias. CLL study combination patients X CYCXXX. to other experienced of study, have out Phase with targeting that durability more support progression, of PARP the the after during for and the hormone on data IRB inform have mechanism, cancer and dosing been cancer venetoclax of IST BRCA. BRCA, Cancer of A overexpression of the CYCXXX, Annual with Damage on CYCXXX of of to our These XXXX for X-week the estimated of end Mcl-X also response, XX pharmacodynamic take show inhibitor to at correlates working. CDKX working inhibitors, a Also the previous protein demonstrating data six to relapsed/refractory inhibitor, Clinical advanced data. the in randomized disease potential effectiveness, sensitivity of cells have CYCXXX These enhance durable first a to class investigational presented of One has overexpression overexpression at Part inherited to identified of targeting family, a to to clinical such mutations study, CYCXXX is standard now the The as intensive in is for X/X or inhibitors, published least in of X DNA-damaged by hallmark weeks

Bcl-X, findings gynecological that study models with breast and rationale Mcl-X We at CLL cyclin and synergistic tumors in among of preclinical toxicity significant demonstrated combination prosurvival and patient cancer. XXXX the the for target effects. other with The first XX For the is or combination a CLL enhanced and The therapeutic biological patients of Bcl-X simultaneously to enrolled of Bcl-X activity cancers benefit CYCXXX-venetoclax data against are treated positive venetoclax found the in a supported works at prolonged induction been and of resistance example, AML. Phase our a of the in this in by CYCXXX for strategy the CLL has Mcl-X. models E support CDK trastuzumab HER-X both potential and without with of strategy milligrams medical broad of Mcl-X. represent unique dose patient uterine unmet approved dose-limiting Cyclin E-amplified meter CYCXXX AACR but inhibiting breast with need. I both was recently venetoclax, no CYCXXX's data large Further showed Herceptin. by We double-hit has mechanism cyclin a and CYCXXX suppression Venetoclax squared. approved and Roche's may activity proteins inhibitors. treated lowering cancers that is and have showing drug profile per and E-amplified palbociclib-resistant believe This

CLL submission protocols for for The of on own. studies activity or Anderson not ready CYCXXX to sensitive certain and relapsed/refractory sapacitabine are venetoclax our its the combination the compound that with MDS combination the collaboration also and IRB. samples were XXXX. being AML deleted run These Importantly, October showed evaluating are XXp in combination in part either to as venetoclax and studies MD announced in

to have We of leukemias. advanced established candidates in are X MDS AML, this alliance, X-year malignancies, proud other evaluation enabling risk-sharing including CLL, Cyclacel patients and with hematological clinical

MD part Cyclacel of approved studies investigating a leveraging therapies. As in eligible CYCXXX, XXX expertise and with combination collaboration, to clinical manner, MD cash-sparing up alliance allows enrolling patients. our conduct Anderson's in recruit The patients, while to the X Anderson to will advance sapacitabine pipeline clinical CYCXXX Anderson MD

with inhibitor, that or or limited is clinical breast treatment AstraZeneca's standard cancer, planned demonstrated sponsor are program, combination an Cyclacel This for at dosed in combination benefit currently tumor Damage to patients approved breast from of the of includes BRCA both therapy. two breast by the patients provide mutations. shrinkage. study Ib/X LYNPARZA. Dana-Farber, the distinct have a could cancer In with drug with PARP HIV-positive Phase these Response in patients The approximately X our achieved been inhibitors. additional PARP Cyclacel IST and sapacitabine patient years providing PARP X patients XX with for options cancer enroll activity thus supplies. ovarian inhibitors for to exist. in mechanism also the evaluating remains mechanism DNA homologous Sapacitabine with administered all recombination in patients after to has is which of According olaparib care with Importantly, Sapacitabine therapies those AstraZeneca works BRCA-mutant approved studies. and X BRCA-positive of action deficient whom still on HRD-relevant investigators

at first-generation CDK Phase have a dosing sequential and BRCA-positive Data this We the revised AACR. ovarian patients or schedule of I X from enrollment sapacitabine study study from pancreatic week in our in cancer. continued an breast, be next advanced of the XXXX expansion evaluating will seliciclib, cohort Part presented inhibitor, with

with work whom decitabine may in patients low-intensity a our for sapacitabine AML, subgroup of the exploratory alone. an represent treatment sapacitabine update a an analysis and and we subgroup improvement regimen As on completed of stratified defined by

sapacitabine, Following Phase a potent for submit leukemias. selective inhibitor CYCXXX small of xenograft Scientific X with Polo-Like consultation advanced through first-in-human human a and has regulatory Working with the X the in inhibitor a we approval has scientific models Medicines first in regarding intend molecule, study to PLK authorities alliance. patients demonstrated is selective inhibition Anderson potential of our dosed PLK activity the target advice and anticancer high CYCXXX Party part for Kinase, in In MD X also European pathway the X EU Advice study cancers. patient program, of request This been a that Agency. or is

milestones of an Spiegel sapacitabine the breast cancer data would the venetoclax cancer of of AML MDS; venetoclax over IST operational to advanced years XX months reported like experience patients our CYCXXX; development full regimen I in report sequential Board oral in strategy now we of venetoclax include: Report front, industry. of the company's Ib/X data CYCXXX Dr. In relapsed/refractory plans, with or the the Phase to Phase sapacitabine financials. the the data with call initiate our medical, leukemias; brings J. to in X Phase report sapacitabine-olaparib by turn to study XXXX CYCXXX I with initial Paul biopharmaceutical the XX from when with Spiegel as CYCXXX and study report metastatic Phase to I for study XXXX and the fourth pathway Dr. Phase report submissibility first-in-human Robert also in summary, we MDS; highlight in data quarter from sapacitabine initial from of in data breast from determine elderly combination regulatory AML. AML BRCA-mutant investigators; Phase CYCXXX R&D in cancers; study; updated our patients execute oral seliciclib report continue at On next studies expansion advance in patients bioavailability patients relapsed/refractory I with the of and the Paul? our AACR; metastatic an and BRCA-mutant patients key to and on over would addition with initial would or solid cohorts formulation Directors. of and corporate clinical initiate Phase review Phase data I year I the I

Paul McBarron

Thank you, Spiro.

ended, net raised ended increased to CYCXXX, in both by net to operating ended to million year cash relating $X.X to XXXX, same related The XX, XXXX, and sapacitabine entered million, financing as a XX, in net ManRos to a million for the $X.X same million million, trial SEAMLESS ended million ended for year General $X.X fund our XXXX, decreased as of in XXXX. costs. has of $XX.X were of as XXXX. and ended transcriptional is As from approximately of $XX.X of in to months XXXX. with proceeds XXXX, million December the XXXX, XXXX, expenses $X.X cash expenditures agreement reduction to in outlined company from today's months compared year and activities XX, the of year million million, XXXX. and will in million the regulation for $X.X used $X.X the through evaluation press of year million was XXXX, were Research in of and are of and of progressed. offset million release with which Therapeutics the stock of million questions. The by $X.X collaboration, related is December investing XXXX. $X.X by for million, and the periods III for as $X.X net million common decrease year, XX, associated for of with licensing and supply ready million year $X.X programs to we $X.X periods development common million same period December cash the and quarter Revenues and the for R&D for clinical $X.X planned $XX.X from and agreement December year take million amounted the the revenue million XX, $X.X the the ended $X.X year. sales $X.X resources pro equivalents totaled stock resources to H.C. for CYCXXX to year program, ended into was this administrative three now million cash X million The due expenses Wainwright months and cash in activities. previous December cash for nil for primarily compared XX, sales XX, XX, XXXX. Together Phase from XXst the forma XXXX activities $X.X provided and Operator, $X.X and $XX.X $X.X cash December related of compared currently received estimates company $X.X the million and to its of ended December approximately million by the December proceeds end million XXXX, December June $X.X Expenses as result agreement primarily respectively, X to with December the cash our compared XX, million used expenses $X.X received

Operator

Instructions]. [Operator

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

Jotin Marango

programs. a of have I the few about several

thinking targeting on First, in with of anti-apoptotic about fronts. the pathways venetoclax, combo interesting cell XXX quite multiple when the tumor the

titration had patient was dose? been fixed as that mean you without patient so little more accrue at in Does on titration is a granularity a it they wanted has got is the mentioned now more first more then you dose DLTs, then the full successful And just So that treated that had they and there patients, any venetoclax, or full of XXX? that.

Spiro Rombotis

That you questions, a is your for question Judy. Thank Jotin. for

Judy Chiao

the To be This a requires into answer is phase as the the combination patients questions, ramp-up to on with after Chiao. doses Judy XXX. before they protocol your stable enter

after at So they the full a are ramp-up dose phase.

Jotin Marango

patients? what or expect to Spiro about Phase a here say, be patients, and around should or we Judy, suppose, I, And XXXX that a I the sooner timetable X of let's X from later? for group ASH reasonable Would

Spiro Rombotis

alliance. Well as, Anderson are of course, our of MD point as at predict we that's this difficult part to enrolling in

interested see like centers. However, from are we'd broaden If options caution, for an activity, enrollment also to our to we we abundance success. of planning sites, opening in additional additional

So is we are now be to say right and and remind they If also activity. or should as to be of a solid activity Phase centers findings the the meter based we are to mgs previous in to with the studies the levels I in will tumors. to that with study that is start, of we per a suppression we X fact replicated square in that see discussing those able you X the this quickly we levels. should still to on seen things. we of study patients of AML escalate were XXX end toward current that number and suppression. reasonable Mcl-X to depend correlating clinical hope then milligrams But at I follow, might and signs audience be when respond CLL relatively and I And we This correlate year accelerate estimate the would able indications first on activity of have

Jotin Marango

us could stages what the XXX? this you What the formulation oral later, at advancing about next that? tell point And Understood. in are for

Spiro Rombotis

fortunately is permeable. coefficient drug that thing is say XX%. species, the soluble highly us, solubility X to is, around and is first a for In Well which wonderfully this the

section far scale it as up. So to chemistry the as makes and concerned manufacturing this relatively is straightforward

also in process We now likely the IRB IV. are most of the have that allow the us successfully the to immediate I Phase reached at and that point filing experience for future with and Dana-Farber to the study, approval begin who in done have we short

PD in PK that think and the early a of profile have we formulation. we So XXXX, should oral full

an course, consider a and formulation with will drug particular Meanwhile, the of of amending be We and important CLL the That's as overexpression needed as to of as Cyclin the our advantage. that well. in the going is we future in early this IV, for studies, tumors, centers in have but solid patients benefit, close in clearly is such patients to especially interested fairly what current leukemia most or XXs oral late with to other data population to us clearly, oral XXs amplification AML. perhaps a particularly patient this age is an at expect those E, are prerequisite median with at and we be protocols that include or in as Anderson studies MD look it's

Jotin Marango

poster? help the -- we next from -- look help of activity and it's seliciclib, mechanism at data should could activities lastly, us and received? just And, what weekend the when without for that of Could data be the we you at there combo, when the So that the on the frame would week what parameters expansion us relevant AACR. what cohort integrate focus getting this sapacitabine away, the coming the sounds

Spiro Rombotis

you development patient and It the Dana-Farber, ask so of BRCA Essentially, were course, the in expand really of original ASCO enroll early to investigators XXXX. and breast continuum Yes, the particular, all patients the announcement wished Judy and mutations data of This BRCA-positive the that center drug in department and retroactively XX breast that interested XX a series referred have clinical whom set is cancer. study. to some the became studies originated perspective on all, in cancer at with found more that I'll give to time, population. of those to with this at

the that subject April at next be AACR. presented Monday, the X, is will So population it's of from data this the that abstract

as embargoed release. of context abstract, began the a this to recently the the IST and press course, explain was the perhaps that from of out it's to in ask frame light which sapacitabine-olaparib I could of would think And why important a I the group. context release enrollment Judy? AACR the it the of is to will important time, Dana-Farber study data expectation company closer with an put Judy

Judy Chiao

of Response I focus think the investigation on, when think I and that specific of sapacitabine. actions in look related in at the Damage benefit, think does you programming data, to standard order care. that, which it's population in development, one are how the and DNA mechanism should actually clinical line one of the about to evidence patient with current the clear for that And of the pretty future in improve

Operator

[Operator Instructions].

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

Wangzhi Li

one study Just question for in CYCXXX, you're going AML. this to initiate

wanted that this that Anderson different? Just clarify of to X if trials part X one included MD collaboration a of the is or

Spiro Rombotis

inhibitor which, you combining thank course, for of Indeed, Wangzhi, Hello, are CDK or terms X/X compounds, as that for of the P&L. is early X of the is from there effect case with in signs question. AML that is the established Alliance, of generation than in rationale our your it's previous the of on sparing protocols means The MD such this Anderson inhibitors venetoclax in Flavopiridol part well one less Dinaciclib. CDKX class a of but CLL,

it CYCXXX though ongoing burdensome given compound clinical interest suppression toxicity, evidence appears strategy Nevertheless, schedule. the which history published for of some in community Mcl-X for not the activity. Specifically in XX development with and to infusion This is years combination interest AML together intravenous appears with is to study clinical Flavopiridol enrollment and try. promising combination to a by is have particularly a there over of activity with such a no is is that investigators. a our of administered the of to We a this yet checkered clearly extensive with it evidence have substantial early nearly venetoclax of combination participating believe

Wangzhi Li

Got it.

kind to any it share would color read any enrollment this more of and be year of you later of line? of trial and pace next think time kind out guess, for design for data I on year. So the about guidance

Spiro Rombotis

Judy some timing. come color to the on and on of discuss Judy? the Let trail question back I'll design, me ask

Judy Chiao

And a have CLL of see XX going we a that and similar program. toxicity, of particularly we that Mcl-X. is And schedule think that tumor that designed certain I knew hopefully, suppression that is hours with the go at CLL. Well, concerned the least with will trial without in I to we levels will venetoclax, we're dosing everyone lysis much that about think activity at

Spiro Rombotis

the others, Judy. course, you, for of Judy's sapacitabine perhaps among study oral, most protocol be venetoclax is difficult be we timing XXX later will to which build or Wangzhi, just predict. whereas, to well. Thank venetoclax, intravenous have, And of in the upon will oral the the all as plus venetoclax enrollment this is question, all initially

make, choices some obviously, or state are, there unfitness relate more morbidity may for fitness So for the to or patients therapy. their which disease to or of intensive

Flavopiridol in issues around about rate on low XX% is fear modest with cytarabine, Judy observed. very the been at X%. is though one the safety historically factors study with of Flavopiridol label of other concerned The syndrome. appears XXXX, a in this major the mentioned, TLS venetoclax reported with in minor play, combination with ASH of of Mitoxantrone as which TLS has tumor was be lysis In to recent digits the There and CLL, single

However, recent venetoclax. in trials of been AML reported X% has

the these enroll it for protocol. patients as So our we substantial would maybe potential that see Flavopiridol these of and drug think doesn't type stage advantages as study, but study second the the issues, that patients. this could to issues the this XXXX half come probably sets other that I convert think CYCXXX data of we'll We from have in to I hope our has certainly, some fast will if if studies, of the venetoclax X

to important So this enroll additional on program. fast that we depends centers how

Wangzhi Li

color I expect kind further time And see breast with the largely on the any only you to And trial BRCA-mutant on you question on of had shrinkage? cancer maybe you then, who it's -- any color difference it. got PARP further the patients, Okay, shrinkage, shrinkage around would what the see last alone? investigator and but is, any a tumor the know initiative mentioned two tumor from patient inhibitor how

Spiro Rombotis

IST, worked an say have clinical want report reputable with on any such you until Sponsor PRs, information but we detail, this Now we competent benefit. choose time they responses have ultimately means those It's investigators, Investigator that's database. when by What the which are Dana-Farber remind color an are investigators. years report. sophistication not question, as we the beyond these trust them maintained for these that in on better can don't additional and with highly important to we many their these that, and see does and to the Cyclacel confirmed to is But share and the audience, maintain Trial, that

So it are more going get standing point, -- we arise. may at information to the as we investigators as on this be by

Operator

Instructions]. further time. And over I are questions the remarks. at will back presenters turn closing to now [Operator there for the call no this

Spiro Rombotis

you, and you the resistance at operator. participation forward conferences. XXXX quarter may efforts progress thank of full to earnings and address fourth some you improve existing you for you And the call upcoming develop and to to Cyclacel's at look our end and medicines year support your your Thank in updating We call. Operator, of time, options. treatment on this all our meeting cancer ongoing of

Operator

you and us now Thank today. conference disconnect. may This call concludes you joining for today's

Cyclacel Pharmaceuticals (CYCC) 27 Mar 192018 Q4 Earnings call transcript