phone Directors, want that large of be particularly everyone. pleasure for proposals Board to a of with and report were yesterday's our Meeting. by to to successful continued I'm margin. I Good It's very all you and On Jeff. shareholders by employees your on support. morning you, the Shareholder Annual you, accepted our Thank pleased after my thank the behalf
a outlined be few during I just not our conference ago, call weeks As fundamentals our could year end better.
The we oncology well-positioned business We to that a investor-friendly XXXX. to Celsion in of chain functions all initiatives and to a ensuring new development positioned some generation. medicines important NDA supply year financing robust for planning, our across the are of have taken multiple steps from our our all clinical most have deliver last
call us is said, be I last have just a over well since it As rehashing that bit previously been most repeating. so of a worth may with bear it's But month information we I our shared.
held over incredibly projections liver study year. in last you've we've our Let with Celsion a emphasizing by position considering can most today and delivered no our that taking our in on Phase years primary to-date X for see various of Enrollment funds we a promised been in be drug be $XX points million as ahead press the meaningful pure-play hedge I've of cancer balance is me technologies, for patient OPTIMA Celsion is Phase if communications $XX warrants as you ThermoDox start saying August release immuno-oncology used all us our this our made today unique was study been HCC pure-play or part, program. investment, know our paid structure completed in Investors the known clean year. carcinoma, also our our XXX pivotal and for hepatocellular that X can pure-play of enrollment calls, position in global science, to over for for research of a million position investors a strong by conference as a that biotech our and cap our clinical ongoing that a because a will development these short and sheet programs during with following important and leveraging GEN-X progress programs. our our past morning
We preplanned needed analysis efficacy are expected the year a to study this and OPTIMA analysis if first mid-XXXX. now interim later the for of second looking in two forward interim
Our Phase Small X/X trends positive most X small recently from promised. support we clinical pointed from OVATION results we in opinion trends, out nonetheless, as but has numbers have comments program captured This of and quarter study XXXX second hopeful in leaders was a initiated development striking immunotherapy in impressive admit, Phase the the and have generated study. FDA.
we study highest partial During and the to doses. which the XX% highest Phase immunotherapy scores at ovarian patients this you response complete I call at reported remind patients and Xb treated program quarter, cancer That's objective OVATION of in two going responses findings. doses. the two data in treated from past rate. resection in zero the XXX% final we I'm
And operating you those to For share through the used will no surgeon that sell all of can patient's Moreover, another an no And kin he two disease of the importantly, zero tissue little is of years, want of investor-friendly the discounts, well with that's years financings room the the we the be most tells a been into a over the half losses, know early past most it our leaving have resection leverage X.X price first and that's XXXX. runway that strategies with to in nearest warrants $X of all finished cash well time when got operating position. margins. what investments, million dilution, short Jersey in prepaid extend New NOLs, and some cash, our achieved no after $XX state progression. quarter clean removed million with We dilutive to remarkable substantive assets. median in XX% improvement the a events and
potential value clinical we to and sum with create the for with for expect medical a our sheet, up, the patients, transformative our announcements it our So, two to and shareholders, significant near-term for strong community. balance from studies
again treat particularly for candidate drug radiofrequency combined with trial to our to I talk are evaluating new with patients study, background OPTIMA who global ThermoDox want ablation our Now, some HCC those to Celsion. diagnosed about the pivotal newly
Our annually. be is is three It's is major need after at X% event-driven OPTIMA end deaths. in dollars. to conducting cases markets being analysis show with events improvement the second the million in in is preplanned survival to based representing growing the which quarters survival. and the about the medical or final at at XX% HCC deaths analysis global primary largest XX% in countries deaths occurs of China, XXX overall point OPTIMA the XXX remaining unmet acknowledged plan oncology. That's in analysis incidence new a Asia-Pacific. XX if OPTIMA's America, North is The -- the all conducted XX% Europe, study XXX,XXX for powered analysis. of XXX is or stat two XXX a needed of XX% designed efficacy final final on interim required and first the a the is
guidance much interim not for to efficacy however bar successful analyses. with the look first want second at our will we probable at It's estimation believe is regards greater. The I that in We high. first reiterate to interim at the the we probability of success the success quite but our believe be is these Now, possible, that look.
in as completed study enrolled with far, we how reported meeting we following; Monitoring population three December. the the have the outcome So, review From early review. in quality checks following soon and Committee event the formatting So Data XXXX. We'll the the DMC's their very we of to that estimates expect our XXXth the report OPTIMA in doing? for as are previously fully quarter normal possible data line communicated occur
eight six if interim will efficacy analysis to some The necessary months follow second thereafter.
the identical to We group shows four half have and also like progression median reported study what than months observed enrolled a PFS HEAT to The approximately patient great or XX.X PFS analysis study to recent time the from deal most population. I'd months restate that and is continues fully a the that's months that survival of exhibit in XX.X promise. to the XXX a median Study that's better OPTIMA subgroup from we virtually approximately progression-free
three-month improvement subgroup. HEAT more resulted If in in the study subgroup overall a survival that PFS improvement this there are you in two-year subgroup in in than recall
careful not want tell predictive from the nonetheless. OPTIMA to excited outcome to out we comparison you to can PFS I point and I the is study that be that be the are of the may Now, study blinded and the data HEAT
remind preclinical independent single well-controlled unmet more again, dose at oncology, a with retrospective not that X.X single an well-controlled entire of to by want not. In studies. a survival looking success the to findings of that the results very company NIH that a We important the how procedure the an RFA I prospective ThermoDox time emphasize is can In very RFA medical then XX was in in only prospective plus success over HEAT to case, a for benefit need subgroup. identify population improvement the We quarterly standardized of We received significant I is We determine results this ThermoDox. say the journal. applied months the a this soon X.X years published intent-to-treat the with this I'll approach, finding the NIH advised not well-balanced protocol subgroup dataset we then with the It's ThermoDox, we will a XX peer-review and that in Rather even I'm More largest skeptical then RFA, group prospective exceedingly group group confident to patients confirmed well-balanced survival you and analysis time prospective following or in patients and this of soon. combined our suppose you a without to and HEAT five-minute and working analysis variable point Now, overall years the years of subgroup. RFA that is It careful the median and than study death a of according were plus/minus was and in reached was look single was overall a short ThermoDox, a of was in from dose Study, determined. of variable forward assuming Meanwhile, be Study two and subgroup this minimum XXX plus be minutes. the key statistically ThermoDox. subgroup that and the backwards. survival. saw with nothing of that in than HEAT the greater improvement never ThermoDox dose astonishing. to then XXX a to treated the followed presenting purists treated manuscript determined what through separate increasing in a procedure success. and RFA but
European assuring We separate for market Community. initial our at are research factories are the our pipeline two that NDA prepared plans launch in rigorously the We're establishing one commercial and United in work conducting United drafting hard China States, the from ready. on three States and China, and our
in activity. in escalating like I'd future tage presented Interleukin turn in GEN-X now exciting, published OVATION XXXX patients biological program the GEN-X's five ovarian of OVATION oncology evaluating ovarian demonstrating newly with immunotherapy our diagnosed -- GEN-X, describing we've Data XXXX in earlier XX the in trials our our X safety, completed equally was Study. particle dose version edition So system. and phase IL-XX, Much cancer, we're to II or X in gene delivery X at to non-viral cancer. OVATION and ovarian March To-date, cancer In October to but biomarkers, Study this nano that's II, X immunosuppressive from exerts repeating clinical doses. symposium Phase clinical mediated multiple the two highest GEN-X SITC translational ovarian with worth at are a ASCO pro-immune in and doses XXXX findings microenvironment. I improvement plus that neo-adjuvant earlier objective cancer resection mentioned treated resulted patients the XX% XXX% reduction and chemotherapy rate X This remarkable appears scores median at that to that time in tumor the patients Stage patients GEN-X in a XX% the two change in treated the RX response evidence treated a surgical in highest data remarkable response an across and marked progression. support showed
in progression know short we've findings progression to know, accelerate been know represents beginning ways population that you sufficiently extends a these for development to with program. clinical Delaying as our for this look we patients. cancer end these we to Conversely, life. impressed the Now very
the progression even have GEN-X that Our impressive, We is potential significant will know overall safe. delay data thesis impact suggests may our this. set that data is early a in and is and improvement The evidence skeptical PIs disease that The and a survival. medical have to the advisers. translational the clinical early most to achieve GEN-X in irrefutable significant is
call was in As I not we telephone pleased. paper, mentioned data with we short an could be these conference which informal white last to agency, more the month, followed award presented FDA by a an
and is clinical for radiology acknowledged as factors design population. as benefit the target however therapy It XX was and the pointed FDA The in I'd so and our surgery. that lasted and point, read. minutes. to great PFS prepared, IL-XX established end last -- XX tenant couldn't for was As and neo-adjuvant a asked have our our an FDA arm that than trial long we a minutes. approach a assess control for I received constructive interested We fully Moreover, to encouragement planned more discussion. say for more innovative March, Recall, our a without is provide to it was we professional deal difficult we for confounding GEN-X's independent advice. could said assess views acceptable pointed for out independently willing of repeatedly out call be
breakthrough So Phase we if future study, that and small with data FDA face-to-face Phase submit meeting steps. asked supportive They it II is for a we FDA X next consideration Once our following accelerate in randomized designs, clinical potentially X also the choose. OVATION development. data discuss to so of develop the Study dose suggested recommended our the from subset to established a trial
patients end mean? from this already ongoing to this does all Phase the a PFS, a believe outcome. being is from strong would see as do I signal. Phase of an is what confirmed point like identified randomized positive submit as we an primary So they data to trend Well, X invitation in believe, X trial, supportive a accepted The subset positive. study. see we the exceptionally And that
this again, Now exceptionally been not as attention. said have of lack to study, taken II make are continue majority of enormous repeat you negotiating before the as I contracts attention, effort. our while bureaucratic to committee as in and for and the full the which of and we our progress I've have started. full has like of has And all And time. reviews I've difficult of promise can't are to OVATION I'll prior delays, associated the get up the biological and an for said calls, program will it's amount
of including Canada. we expanded sites XX time So much planned to steps have new taken originally in States. candidate possible. We've loss to as ameliorate XX for United for was study sites this sites, several The as in the
expect end half we've made that of date, two this is of As you and available beginning Meanwhile, recruitment recall all year. this have as XX initiated is the second the phases. recruiting XX We with by the sites year. The to underway. designed estimate trial of be data in will will
squared. dose. The six dose in patients at first milligrams with is This at dosed phase phase lead-in per higher meter safety the evaluate XXX escalation a GEN-X will
of The second randomized total up a phase patients, to enroll to will one. one XXX
study. randomized a it's So
neo-adjuvant standard are will GEN-X therapy for on will We in know with treated in X. be the study surgery. undergo arm of from cycles effect alone. Patients X with interval X receive the the for control study, of neo-adjuvant data. GEN-X will it a patients and and tumor That's Patients and chemotherapy. translational the burden will progression-free at also sure the chemotherapy then They high survival a Stages debulking weekly
Following Patients receive arm alone. will control therapy GEN-X surgery continue therapy. in patients in -- to receive therapeutic adjuvant the plus arm in the control will adjuvant
the the ability treatment With potential eliminate for we're progression our cancer. study a we're immune the recurrence the earlier, in hope, said have to GEN-X's I as that of -- follow-on will objective, blunt, expect, continue virtually to hopeful the impact to the primary GEN-X's or confident recruit Our is we PFS. system, perhaps,
our conducted released label patients least end after by the events, the whichever after months, study PFS study at primary overall, open it is the or followed point investigators. clinical for as been observed, trial, the least data been Under is analysis disclosed later. throughout have all XX have or will be execution For be will PFS at design, XX the of
to Now, one last or point. make other important I'd point like very
supplier XX% drop by will GMP result, supplier. -- our batch completed. That's to our batch European of as over plasmid a our by first Plasmid of that costs, produced was high-quality current Our compared Hisun. as successfully cost-efficient
major, the Bottom at Our and our scale, for is program. represents manufacturing reduction of goods compared supply development magnitude program in as increasing, an in as established sold, of CMOs pricing cost order have commercial line, a cost and predatory critical organizations. reduction major GEN-X before, of overall milestone of said almost success we'll the contract to the that's consolidated chain rapidly I venture an
with a company, from the enrolled cap I potential So OPTIMA you'll With we a readouts short are There Phase and are our data in, hope for are now table in there year. position. agree All on that Study X important for returns. extraordinary we outstanding, is track than to fewer that XX months. our a fully expected in shares coming no HCC warrants million leverage standout
We and recently, healthcare are in ThinkEquity during month, coverage, actively you, new with with are May. and remind engaging expanding Oppenheimer's presentations our Investor Most at efforts research Annual and are archived listen our and encourage financial I'll view new presentations presented we conferences. to to this investors March numerous the Conference to Relations call available results to over turn presentation corporate I slides. and These for you webcasts website. are Jeff? discuss like Jeff I'd our XXXX, Church. to our Then fundamental on
