Jeff we release, you written this and our staff This over today’s team reviewing of I been of you, with in positioning this to accomplishments I very it you help, XXXX. Jeff. reviewing in small morning, thank press for us joining for achieve Good able feel for for but was XXXX this success Jersey believe here all call. Thank everyone New morning, I company proud was the well thank that of Central that. and has couldn’t
staff, to listening So, all we commitment the you to on behalf our thank of staff much shareholders hard mission. very in, and for that of work Celsion’s your is
phase ahead known global two we're needed, in now the patient been press know the you you’ve enrollment I'd accomplishments, that conference projections capitalization following programs second mid-XXXX. in analysis made promised sometime as pre-planned our, strengthening this past OPTIMA efficacy primary ongoing and across various XXX progress carcinoma, pivotal like our later our looking releases our ThermoDox on liver to the balance cleaning year. our year. If will And X of and our was hepatocellular HCC, and emphasize many with that interim first calls, completed sheet well XXXX. of of communications And also August structure, meaningful the interim we’ve study for OPTIMA for to as in over our up delivered be all expected our study as of then Among forward GEN-X as cancer, if
will more this discuss minute. a We in
the of to results Our generated phase the This quarter development initiated XXXX X/X say clinical was least. planned. has impressive in OVATION in promising II immunotherapy program study second as
scores million and data enter for two and final a being XXXX, in responses for partially study time cohorts. in I is in data program, treated phase that's the We progression ovarian response, complete RX some OVATION XXX% resection for quarter investments. the treated those During in those patients two the the you dosing improvement at RX cohorts of first for know, of reported XX% showed and known prognostic immunotherapy the patients treated RX at patients in we XX prolonged These best, as protocol. dosing who remarkable from And Xb median highest XX%, not cash objective highest an our may survival, XXXX cancer. a with
in no promised, that sound with positioned As value used well dilution, leverage share can discounts, right the medical create programs resources and the and price transformative we are most investor say fundamentals, solid strategies, with to milestones, significant [indiscernible] structure, be clinical patients sum through shareholders, warrants and no our up, see for achieved a this the all friendly little to to sufficient very capital our so, position. through community. and I’d doing we it
our known to with primary I’d talk candidate, combined RFA lead cancer OPTIMA ablation, like liver Now, treat the ThermoDox, about evaluating to diagnosed patients. also pivotal as radiofrequency drug trial, global our study, newly
who those background. are to give some you want new For to I Celsion,
about is X% These need statistics It's come annually. largest incidence from the medical largest This today about oncology. irrefutably, at need is HCC global the latest medical Our XXX,XXX. Database. oncology in growing remaining unmet Statistical Global Cancer unmet on the
equal was show at events pre XX% planned on deaths. Europe, is America, study study North OPTIMA after and Asia, analysis, OPTIMA OPTIMA’s to XX event based the occurs well indication. a The efficacy are stat is The endpoint markets market, this being the survival. countries improvement We overall XX% final powered too or in to data which XXX interim all design for positioned analyses. conducted in China for major primary is Eastern X.XX, the the plan, survival, p in driven,
second can meeting, and required analysis. DMC From XX% completed following. final first enrolled at XXX that about the is the review the of the analysis, XX% deaths its of of in number of fully deaths The we report of December. XXX if this The final needed the represents population the
three, occur which the with early previous XXXX, will in line our quarter that communicated estimates. expect XXX in is very deaths We
enrolled as a eight the will We also will A what six study we from that analysis the than possible exhibit identical better to the as report expected X.X enrolled from promise. follow medium have following from preparation necessary, outcome to the soon can XXX of or subgroup quality a group population. second checks patient the recent virtually thereafter. that would report following some Most study study, study review. fully continues is We OPTIMA approximately deal to XX.X the normal great months fully months analysis, PFS if of HEAT months in the PFS DMC’s shows
key without to standardized prospective ThermoDox, two More was was patients by nonetheless. make to in result what data that with the analysis But the and in apply the not HEAT looking management short we OPTIMA RFA to comment we out the subgroup studies. to the will saw than me this ThermoDox subgroup, You a variable. this study only quality the OPTIMA month astonishing. the to to PFS intensive our let improvement of would again, in that to three need protocol prior years a variables and I is the nothing more did also In minimum want combined were X.X determine based. the a treated that resulted the a HEAT recall you may followed years study this at the benefit, We and dose group We that we team so, determine is following whereas in point working comparison be identify balanced HEAT prospective of this through I the the the survival a XX quarterly a justified, the for dose year two XX predictive patients If then of of is about that say of balanced PFS then want in XXX treated and and in subgroup, controlled skepticism by then RFA discussions group again, more survival determine study minute preclinical population, study I’ll is outcome. remarkable overall RFA in subgroup, not case, subgroup that single We excited at on which of benefit. this say and looking tell largest months with blinded key from unmet careful year each well that benefit procedure backwards. working success backwards. minutes single I in be according survival the than then ThermoDox. oncology. well be the careful the patients than XX a two can not XXX survival study with well and medical we XXX results from
Now, dataset from but entire of can the increasing HEAT skeptical, the heating remain results significant independent separate survival the NIH NIH improvement. independently the overall purest analysis isn’t. that ThermoDox time confirms in In procedure study, a of a statistically plus RFA an
factories, separate at to NDA and one presented in prepared that forward endorsement RSNA the that only We're crowd, in ready and with supply at trial from successful. pipeline drafting our China, conference, and assuring company working will moving commercial United is the standing a go. on assuming the the be to So three that the rigorously States, hard room two are
our States anyone's and for plans conducting positioned our advantage opportunity to rigorously China, is Community. frankly European research by We’re it. initial take and of establishing launch could and blockbuster we United believe be definition better a We this not for market
our GEN-X, So, earlier study. immunotherapy equally cancer, in to mediated we’re clinical cancer. very like our II, In with in trials GEN-X and trials. very important diagnosed exciting, important, we've IL-XX I but ovarian safety, newly gene patients To would turn ovarian cancer, program the safety evaluating to X II phase date, based ovarian demonstrating DNA stage X five in OVATION completed in OVATION
newly study highest that tumor without mentioned And PDX. remarkable chemotherapy reduction pro-immune the with to presented trials data highest translational from progressioning. surgical OVATION nano XX% that micro-environment. multiple describing show resulted five this and and that non-viral support study, and X improvement FOXPX, resection a was in biological X in plus in treated patients PDLX, partially including at significant evidence the GEN-X GEN-X’s ASCO published and exerts March and immunosuppressive I responses a X RX a dose delivery repeating, and marked rate, treated XXXX, demonstrating clinical findings two cohorts a of percent in in system. worth treated This response biomarkers, clinical in across our particle that's IDLX, phase time safety, at diagnosed substantial scores stage in oncology in the complete a Much earlier So I escalation SITC dose patients neo-adjuvant dosing activity. cohorts. the October change X future Data to response median two appears objective patients at GEN-X
Conversely, you end findings cancer program. progression know, So know short extends progression launch. for sufficiently population to impressed accelerate very to unfortunate patients. a represents been this to these we we that in as beginning ways these look with for know the the we Delaying have
is data the We this. is know potential achieve even early progression that our that may PIs GEN-X and medical significant to is the early significant irrefutable is a clinical translational and the thesis suggests advisors. has delay GEN-X benefit. impressive, data evidence The in Our safe, to skeptical most have
asked to XX have while conference these for FDA an So acknowledge we discussion. award for followed agency I'll GEN-X, preliminary in XX we our and the and minutes, put to short to prepared, great and call Celsion that presentation, we again unmet translational deal white ovarian for were informal Friday, in lasted this of future constructive which GEN-X a participants recently our planned views agency more the The and a very was and Moreover, presented of for this quotes, call IL-XX not that willing to not data by more more I'd a telephone minutes, development. need approach cancer past both could tenant provide be interested in work professional The an innovative encouraged The paper summary, the data, it say pleased. for complimentary to past design our population. received and could trial was encouraged commitment was than clinical was our to a advice. very for and we The continue very FDA the is challenging exciting. and were target encouragement repeatedly
however, that clinical or During some as read. an was independent did We benefit the the to FDA long established primary independently without of meeting, acceptable having it was radiology GEN-X’s assess point was endpoint, controller. the fully difficult so that The PFS this. outcome a out, was
suggestions subset with and FDA II consideration, being, dose factors an to accelerate submitted data Now, going might designs, the forward. our us study choose. also Once They a therapy developed our we X trial breakthrough so small study, FDA supportive potentially to the and future OVATION randomized that asked are phase clinical II that if randomized established provided confounding discuss the we development. data from of for and in the be is neo-adjuvant recommended in-person surgery, the OVATION meeting these so
perhaps study. later. all they endpoint. what the to So signal, of GEN-X confirmed to And randomized work that perhaps they're a is and would a see than OVATION important. favor, this product. The factors neo-adjuvant outcome. II GEN-X identified an of therapy from And primary submit supportive RX that would X believe to phase does study like I like strongly PFS patients our from We phase confounding an favor use the of surgery Very would as infer the resection suggesting to ongoing exceptionally mean? data invitation rather in patients rate encouraging is sooner strong trend see from assuming this we that even already a subset available see our the in our they to accepted with continues this
could the more on behalf can not we I So be participants, company and our pleased. say of
our in Moving in get two the cancer you this it's the by ovarian for pro-immune full of I’ve we Meanwhile, OVATION their started. first designed beginning of that data US IL-XX. research. exasperation, have of has attention. the calls And on, sites June their said recall, activity say, taken the XX costs and review they study And before XX with doubt was with safety as bit There's committees. not reasonable DNA the conference reviews our independent the budgets, steps A have online sites mentioned some half also end XX clinical year. got surprisingly many and support review trials, originally institutions before will made all issues. as concede planned all to to to -- some the the IRBP of of the if can lack with underway, have in been not this study II available case the you NIH’s a done. kinds difficult budget contract initiated phases. tier to, I are XX%, based to all data we're we not extra were decision little to will of end promise sites is I Consequently, And also. the recruiting study now I we can second we've we to terms. effort, seven the important that has translational required make central have budget. promise of in We've most expecting you proposing from you, third I've of that the we be challenge consider where as right that, to told call, much I for which the and technology, biological committee The I the prior is estimate all a trial, delays, program review being and as a recruitment Canada expanding is taken year. we supports and as And added this recent little by them however, to possible. now that our while to into I The those study and development of That not the for in expecting can't approval initiated. program up investigators for Because time ameliorate can't XX the negotiate exceptionally patient to no to state you. considering say of have getting and expanded we've think started two just more relates biological over institutions BMS, I conference to ago that Believe confounding in sites associated
is squared. XX% saw This we escalation phase for the not will approximately GEN-X. This be is than study, a dose will lead safety. patient I. GEN-X XXX OVATION milligrams phase with is final meter in first this higher The randomized per at dosed evaluate six in the dose every getting patients a Since
again to one The enroll a patients randomized will second of about one. XXX phase total
which they for are to. chemotherapy more one in chemotherapy, with X the study randomization, interval progression. weekly GEN-X’s of randomized this on depending cycles are neo-adjuvant impact plus GEN-X on then surgery. neo-adjuvant undergo with arm Patients So alone standard sure, or treated Patients
patients receive the will PFS, therapy, objective control adjuvant to to progression ability primary blunted. given the arm therapeutic GEN-X’s said is be be GEN-X immune surgery, adjutant system, will our arm recruit Following in the alone. therapy plus with continue in I we cancer expect patients to
hope Our eliminate perhaps even it.
disclosed least all is observed the For have execution it as overall, by XX events or Under clinical the the analysis study study’s is primary primary least trial, the been released after the of data XX conducted months, PFS at whichever after open be will will following patients been for later. throughout label, at be design have investigators. the --
that needing be will program. DNA development And administered of high patients. to If believe in companies enrollment allow We've are track volumes the the now phase development successful, us and points, we the concerned the are portion enrollment now more will to end we’re than combined. development to perhaps -- patient all committed we like That's to missed. be very GEN-X X world, other our of complete to additional in the largest XXXX. to Importantly, to two I’d bar GEN-X, important original been our DNA about particularly that we user will faster initiating not none, timeline plasma objective, of or and facilitate regarding sites out it. plasmid the by us consumer the in we cost DNA point the using enable other it's -- the
our this, by Plasmid efficient supplier compared over of high to efforts of of costs produced from GMP XX% was first to What this completed a been Hisun, as week. batch will drop program. quality that to the Hisun the is success European you So, can by costs very our plasmid our tell cost reduce important I have batch supplier.
our overall synthetic costs as program cost manufacturing increasing we ventures development program. goods major cost. cost supply reduction ago in to material compared consolidated pricing and an or line, reduction I'd of was vector of polymeric the GEN-X in GMP success to commercial scale, represents previous and of for of order milestone Bottom initiated XX% at and was predatory COGS, This is established by over as say almost rapidly of a the said, the contract sold have Additionally, I magnitude CMO chain XX the organizations. will months critical, are reduced about
point. very important Second
this think last I’ll consideration this file deal a the deserves to of morning I your the call great of with investors. from attention also XX-K our page SEC.
You'll notice XX.X part that XX warrants expire There remain company stock the milestone short week. numerous it the the shareholder to not of initiatives event payment table. standout my opinion, for X be conclusion, our fewer I that can we're for made have choosing, oncology. potential a until shares year. are work that million, subsequent months clean a a phase therapeutic either a as cash, companies the or extending full extraordinary. terms a event leverage is In from cash belief the which we next GEN-X, standpoint, payment you’d renegotiated OPTIMA trigger of expected number a than for and GEN-X study in and to that capitalization milestones discounted for fully in was are in, on few may in potential an as We the implemented believe a this concession original a to choose its is is has million million. important on a be returns, confidence outstanding, settle option, company $X timeline the All shareholders the phase non-strategic important no to X XXXX our payment is an from indeed meaningful the for program up the now of completed deeply We vote that hope achieved. at GEN-X with discretion extraordinary XX a agree there's the Also warrants in position, sole
of are March investors numerous actively at encourage Healthcare coupled and through not an operating Jeff? our we approximately and sale operating I Investor presentations over that recently, Conference XXXX, our million X.X available a with Jeffrey and In it. be our discuss presentation XX. XX expanding I A archived XXXX. I'd webcast invite Relations balance approximately conferences. December financials turn engaging website. Church. Annual could you, call the as we fundamental losses New on runway presented our of to cash research on you To now, Most net efforts with like , million with provides to review we’re within us $XX corporate better healthcare to to word Jersey Last that Oppenheimer's us continued Additionally, positioned. the takes coverage point
