for and call. for Jeff. Good you, morning, Thank you and thank today’s joining colleagues my me everyone,
But delivered about we're fourth past look hard help out still Celsion over out team me we This but can't XX to now everything it's Celsion. do. probably have just of year believe saying set closing Let accomplishment to much to months. I in for terrific by do the that XXXX, a back quarter it start the
a report As year has a can result, potential every I for XXXX, be transformative that are to Celsion. well-positioned year that for we the
August, newly-diagnosed completed. in the global in cancer that As OPTIMA primary patients you ThermoDox Phase announced Study, XXX-patient liver trial III of was know, in our enrollment we
trial, flow. immunotherapy population II, patients. OVATION study The smaller We glide in from they to from same unmet From news as largest, steady this need support patients. over a will cancer now. path clinical newly patients, OVATION research can are ovarian in today. a the now II that's randomized, I/II ovarian And less progression-free this of drug expect important in most cancer available in perhaps, the become more the of the be open-label IL-XX remaining Study, be of year. on reported you than This GEN-X, of And I from gene-mediated for new October, forward successful, first-line data looking our PFS liver survival, study while results than patients. oncology Phase we next If ever ongoing our will diagnosed course treatment year a data, number Phase a the ThermoDox medical outcomes reporting the cancer our past
II along to we us that are the In advised sheet million shareholder-friendly that, with is Authority complete the sell in approaches. the we Development balance announced on that process eliminate cash in depending up be dilution. non-dilutive price. We've the Economic investor-friendly for On in artificial complete a this XXXX, Study, XXX-patient our all its steps strengthening to data will approach, the we Jersey we with our of funds this to Study, cash of focused front, we the see years final established this not with financing year. potential a us tax that's This funding sufficient, taken two losses provide share New virtually to funding, of in to OPTIMA venture September, to New OVATION no only our Taking event the two Celsion expect capital, also have end years. sufficient most $XX are eligible through runway enrollment any upon designed that in rate, from Jersey an by for ceiling
our warrants announced you see Doing Celsion for three a investors, with $X.XX. now common between and and a be institutional stock potential today's just each trading share million to read stock. believe of you used warrants X.X $X common held we the so, share Company If to October XX.X in press eliminated strike has exchanged on these all price overhang hedge of position. a an we've that release, that that price X.X we million for shares the by short
in hope So you can that me we've deal all XXXX position I the Celsion a XXXX. that agree with with for accomplished potentially transformative to great strategy
let Just recap. me
needs oncology, U.S. Europe Both primary liver cancer. both things, the or unmet cancer blockbuster and opportunities and ovarian in among revenue indications represent ThermoDox, U.S. providing in the market orphan We are GEN-X. in HCC access two for other setting exclusive for
regulatory strategy. in opportunities launch broad Our problem. in and all open variety cancers. a both major approval a derived of conducted is will either with is where platform to ThermoDox of markets study pipeline Success XX door OVATION, process highly so, range ensure are Both and products. Phase significant we a the therapeutics, a effective clinical countries, of technologies an Doing HCC a III being provide or from GEN-X, of OPTIMA we research that the efficient and
uncontestable, challenge. clinic. lab The supporting mechanisms and over the for difficult, both and in fundamentals up we exposed, ones it again in a hedge virtually used studies technologies evidence are to is proven impossible over the work. as maybe with sheet our Both are that Our GEN-X ThermoDox the and it's are important no say, The our strong clear. Equally gone. are I'd well We've being Shorts positioned, And balance cleaned was table. dilution. our to cap have sound. established
cancer, studies and prospective and clear ambiguous. and are ThermoDox primary retrospective For liver
overall the that controlled will independently significantly well when thesis combined been validated Our NIH. improve has with survival RFA by
data virtually translational to but primarily risk, more and discussed gate, interest set, Phase no call, now with most operational supported of captured we II data, to we Study small convincing talk For GEN-X, data. of budget names this III the minute. on some The a glide a the about forward research. about negotiations. With administrative OVATION outstanding of now analyses. path data conference and issues I'll OPTIMA last some cancer due important has is to the ovarian look in was out in a upcoming
been of that process has significant are some lost. We the now time making recover to
half low product globally, chance margins. chain with We again, next second expand for XX gross We organizations margins that is year. from include significant the low at ThermoDox are no Our virtually to and costs. establishing CMOs supply supply portion study established and one envision the interruptions for in to a of data to to is Likewise, interruption. plans report with gross with the in I contract progress. significant sites very fully first chain and The market validated, expect with manufacturing supply costs, deliver Phase no three GEN-X, we a
positive. in and from Track the Designation with our committed with U.S., GEN-X exclusivity support respectively. EMA the review getting us years China on turnaround remiss And in job employees I OPTIMA regulatory designation Celsion to that's regulatory Our a all, research. and have ThermoDox Fast European manner guidance again, and And to for for fundamentals. U.S. us is a done. XX a being HCC our if Orphan with in markets, data process people, the the exclusivity ThermoDox sound. consistent in the fine talented NDA before, we be said cancer I'd for seven prior with ovarian the didn't conducted strategy mention is nine-month provides six-month provides priority on with seven NDA in years submission. and in the a FDA professionals be should are as
So hope could fundamentals and our trust I you be not agree, better.
second XXXX. I'd estimates will review this know, meet are to OPTIMA it events. meaning to four do. deaths some in Jeff, at and to in The that interim who of they XXXX We DMC the will first review review Study you they over safety analysis always as as the our and number depend the on late occur. driven, December from financials, start like in turning efficacy for Before OPTIMA analyses then late are best quarter our interim These of time. These two, quarter the upcoming
after We DMC will refine our December. continue time to in review lines the
that some interim with comments preplanned the of XXXX, call want but words, to but I from data of the we Phase efficacy we'll of review. tumor definitive, that to At the Jeff if should the portion Study second with efficacy earlier, to portion late II of of respect repeat response, pathology designed the The II Phase study, XXXX I know expected interim, as made you quarter's data the analyses. is regarding during in I one, the II OPTIMA results. XXXX. two last a we As is first analysis for analysis in other Study most expected track speak the or report this and the the be nonetheless. quarter able half quarter we that the of is we important OVATION are expect NOLs from on time, not final In Initiation outcomes probably OVATION second set will this next surgical about. – mentioned more the will sale expect in directionally fourth be success probably, analyses which of and first
X.X, X.XX. When second XXX-patient was compared efficacy analysis subgroup on of for The with risk study had successful reduction subgroup to hazard XX% that deemed ratio be study will the which the ratio in of the hazard a based, death. a HEAT interim a
have X.XX will the at a XX% death, analysis. for lower needed, HEAT improvement a hazard when to success that a ratio study almost much deemed XX%. for for it or final however, bar be second success of So interim the If risk analysis by in may appears compared we successful subgroup chance this with
Jeff, includes that the quarter development that have milestones So progress in multiple I position. our significantly financial call strengthened our a achievement year-to-date successful this say creative to I turn before of to again transactions want and over and
Jeff, here that, from it take with So
