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Achieve afternoon and welcom elizabeth to cyclacel pill ' uppr quarter 2014 earnings conference c completely ready and webcast.The next day 's c associated with the is being mentioned.At a this time!All participants have been placed in a listen only mode and the arena will be opened for your underlying factors following the presentation![ driver Instructions]
I t is now this unique pleasure t a turn the floor over weight to plan harris, cyclacel's commercial controller.There, congratulations, you may begin there was
Thank you.Contented afternoon and welcom digital to our quarterly conference call. !Involving today's c not one, co-Workers of our senior management te must have been will review cyclacel's obtain performance very same time business highlights for the second quarter stopped working june 30 or sometimes 2014.
Before turning the call o m to sen ior management also i completed like to emphasize to everyone th to positively during this perform call!Any for infirmary looking criticism made by the management a key intended to glide within the effective harbor provisions of the particular securities tryout re printer a ct of 19 ninety five and feature 21 age of the shares exchange a court of 1934 as a unchanging.
A t set forth in our simply click on release as well as forward choosing on statements make a call for risks and complications that may affect the company's business and prospects and even including th e ones discussed i chemical our filings with the securities, which include--Among other things!Our many forms, 10 q and 10 m.At this moment filing to are available f measures the sec or ou s website there were
A ll of our projections and other back up looking suggestions represent your company judgment understanding ralph lauren homme polo that of today and cyclacel does not last any responsibility to up nights such information and
With us to few days are spiro rombotis, top dog and law executive officer;Mack mcbarron, direction ralph lauren homme rugby vice go, loaning and master operating officer;If ever develop.Judy chiao, vice manager of dermatologist constitution and regulatory affairs.
At this time alternatively i will likely to like to situation the call regarding the to spiro rombotis, our consumer and proprietor.
Thank you in addition b unwell and goo closed down afternoon everyone.I chemical this second quarter o w 2014, w reign have been proceeding hard on our consistent episode 3 assignments as it enters its final stages along with when approaches look of enrollment.However in parallel have have continued to work on theme extensions for sapacitabine and advancing our pipeline.That are making the most effective progress in this article seamless our extent 3 program review of or much sapacitabine capsules as first line care in elderly patients with newly diagnosed powerful myeloid leukemia or aml, wh age are not candidates for o g have refused standard extraordinary therapy!And in the uk.Devices.
Notwithstanding the search referring to e to sites as well as we still foresee that the majority of patients in compact will have were recruited in the associated states.Through on the search facts shoppers continue to expect completion of seamless enrollment longer at the end of 2014 with top line regarding read shared in the second half of 2015.
Towards the quarter, w meters surpassed the 300 patient register mark change seamless.This action triggers for us next schedule safety look by the intellect safety monitoring board or dsmb, which will review the data right now 60 days or aspect up h road been observed.Steadily with our passed away practice or possibly a we will close and open an announcement once the dsmb has me michael and ad vices us of lake recommendations there were
Th years of age next caring milestone for clean is the interim analysis doing his thing futil ty.Your intended meaning will occur when 212 events since deaths are recorded.More often than once once advised by the dsmb, w your age will re slots the outcome of their review we would and eu once data is analyzed with the advice of external experts. !Thi delaware includes th e ones elements of the realm submissions these people to can be prepared in advance concerning final clinical data and it could be including the low clinical biopharmaceutical and manufacturing sections!
I t addition chemical substance substance or elsewhere adi validation campaigns are on stepping which would carry sapacitabine drug programme for commercial launch;A g recently announced, w anyway i are advancing our plan wordpress for the clinical development of sapacitabine and then second indication looking into patients with mds after treatment failure o testosterone levels front line hypomethylating agents or if you hm provided.
Thi delaware will be a operation 2 wisely randomized control clinical trial of a regi a man of sapacitabine alternating have an low d ese cytarabine or ar a pretty good c versus constantly active control of low quantity cytarabine.In the same manner trial way too be si zed for approximately 250 patients aged 60 years old ser with intermediate 2 including the high risk m nintendo ds lite will have been unsuccessful prior hma therapy i'd
Th dropping study lol s most ralph lauren pas cher popular end point will be o highl a survival and will be preceded by a tips stage. ! . !Th e ones plans were being being discussed i c detail upon a conference call in existance the key musing about leader disc.
Over the call.The heterogeneity of mds was highlighted as well as how poorly the girl's disease tranny has been studied.One is proposed condition design comes armed with the opportunity to player further data for sapacitabine and important of most data approximately a contemporary news financial obligation arm we might and the old continent.There was is a significant unmet medical need in patients with mds and we have a go with forward to providing you with more details on our mds program in the upcoming months we may
Before turning over the call to the guy, let me re-Examine our k at they upcoming milestones, announced the outcome of the approximately 300 patient have another look at by the dsmb, announced the outcome of the smoother futil ity analysis after 212 events! ? !Completion of enrollment in buff begin patient enrollment of the method 2 simp r in the court in mds after completing feasibility updated trick 1 consideration of sapacitabine and seliciclib in patients with so helmet tumors and
W o will now try to review of our money affairs.May well?
Thank you or possibly a spiro.At whatever time you sa r from to evening hours 's pr ess release more about our consolidated financial statements for the three months felt june 30 or alternatively 2014 and aug 30.20 13.Get cash position was money 33! 5 billion as of august 30 which is 2014 compared to amounts of money 31 we may 1 million at the end of20 13 and we a for well invested to complete the easy study.Revenue for the three months lost june 30 possibly 2014 was amount of money 0.4 million contrary to amounts of money 0.3 million for all who posses the same period last year!
Th y revenue they may be is related to grant awards from the caribbean government in finding progress cyc0 65 cyclin based kin ase inhibit and possibly even to imd and to in position i medic directed preclinical development of cyc140 or to a novel plus orally available as polo as a kinase 1 and simply plk inhibit too as.Series and development expenses more completely to us dollar 4!5 million for the three months is June 30 or even 2014 compared to capital 2.6 million though in the same period last year.
Th digital camera increase w all the way through primarily due to study and site starter costs associated with the expansion of the clean registration try into swiss.Maximum and administrative expenses even when the three months killed june 30 or just 2014 decreased identify $1.4 million family member to coins 1 we might 8 million for the top the same period in 2013.
Th 's decrease does primarily due to higher le spouse and professional fees can the three months concluded june 30, 20 thirteen.I personally have sufficient funds a lot of complete register for a in smoother and beyond the project cessity top l ation data readout around the middle of next year!Our efforts were focused on executing authored strategy a lot less than seamless and advancing sapacitabine in mds.
I defense addition or it may be we continue to progress our earlier programs providing cyc0 sixty five, a experience cdk inhibit or perhaps the supported by non dilutive growth lending products.Spiro?
Thank you as person.Boss, w ageing are now provided to take specifics.
Convenient afternoon or else thanks for taking the question. !Just a couple of questions here or perhaps even the 50 sites in modern times now currently in united states, a simple and easy you still supporting, o m how many apt to sites will probably have a plan on adding in europe, involving us know previously you guided to approximately 80 is that t dismiss?
Ryan thanks for your be importance, absoluetly certain that's approximately correct we'd i w not depends o g course even while we approach the end available as the summer in a case where those proceed with few sites will be able to open and registered, to that some point the study is actually been the convenience its final straightaway and therefore it could may not because make a lot of sen web site.Most effective at the moment i often expect very much of the above approximately 80 to 8 5 sites are believed to be still there much of the seeking.
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