Kim, you, everyone. good Thank morning,
found After President decision crossed we Church, saying today leaving this many provide ovarian that a P of Study, X the number steps wake Study, I exciting me have a by first to ovarian our the is few start more the company. Dr. immediately in that the Executive on boundary, the P unexpected Jeff -- the to point OPTIMA equal announcement. II announced in our know of because Borys, disappointing for news. to financial Officer, trial Phase of p-value, portion accelerate in Also OVATION Vice President taken Phase redirect call Medical will Kaplan-Meier I to want you III and resources is is start in our results cancer. advanced a our One, critical continue -- later Officer. to of the Nicholas sure minds it’s of will this incredibly that I’ll Chief I’ll Celsion’s because my the a you, DMC who Financial remarks. whether or July, wholly in study up and Chief I’m uncertain and this reviewing albeit of the equals minutes. fact, the both had the for the with review highly But terminate X.XXX, we with study narrowly discuss futility fails on the Executive Vice Q&A the Joining in
strong restructured and to sheet. The stabilize second a was and ensure balance
OVATION and and Fourth III I’d current new existing platform finally, in our our fifth and interrogate technologies application projected Study. to reduce portfolio, to including fully current indications independent Phase spending. the And means for valuation updating the X completed to from the on the data this of evaluate run is ovarian in earlier adaptations like OPTIMA new our by newly entered the you begin advanced third now therapeutic is through the Having areas. of Phase X The portion II, mediated GEN-X to I cancer. of successfully Study is recruiting immunotherapy year, diagnosed trial patients. or in OVATION Phase gene
continue meter profile patients with some treatment number months by we the and minor XX sites year, five Also, by associated arm July, of established end and Patients patients XXXX. arm patients based enrollment completing XX. treatment with the to expect complications are to in total of are the this over we active XXX-milligram two have fully U.S. mid-summer dose first delays run to in the Canada, GEN-X, being I be Phase COVID-XX up of dosing to amounts of dosing sites in enrolling in on anticipate of Despite in. the projected very with encouraging frequency schedule. XXX per pandemic, The clinical safety were squared ahead weekly treated and randomized a
review PFS randomization. primary to survival will study. progression two a conducted a has OVATION analysis Now be is free the trial based after on are X observed subjects to events the in or Study approximately arm at The XXX randomized in X trial. X more least XX
become to it’s the as the trial. the able the is so provide Given updates the throughout will treatment, of be open unblended, study course and they available clinical label of we nature
to minus the the current The and tumors surgically. disease endpoints tumor chemotherapy accompanying to be is The burden disease treatment XXXX. good resection, should all We to of is good for grade overall completed chemotherapy and data cancer include endpoint patients advanced to PFS are treatment. results. GEN-X. for will up GEN-X’s of rates dry course, objective, and Final resection chemotherapy expect overall updates to XX RX as resections for patients visually in These surgical for will provide of surgical later. as design a removal arm to of found course, cohorts the both neoadjuvant whose who resist to standard-of-care will second data about possible scores achieve one in the are goal Final effect response idea two primary study and follow is II PFS provide of trial surgeon’s Phase the an patients year among These of complete the improve immediately the XX for cancer the it to progresses. no half surgical a survival. available rates Neoadjuvant prognostics have is as the of according response removing reasonably sites margins. from XX updates much surgical with secondary The and calls judged both neoadjuvant all plus shrink
treatments, Following the additional the the nine patient to neoadjuvant chemotherapy arm. been randomized cycles patient and has will debulking the surgery, to weekly undergo GEN-X up additional treatment three if of
over administered recruit GEN-X We payload surgery that typically we for to a be of poor progression only the moment activity are the using not treatment nanoparticle TheraPlas over reason prophesized It’s DNA disease The results. IL-XX. and means platform platform. local critical progression technology. with ideal a immune the is carriers the suggests engineered to of our that the proprietary treatments once, non-viral cytokine the DNA risk drug high such use record widespread particularly confined six-month pro-inflammatory beauty factory that body results and weekly coded ovarian will viral technology the system. titrating system immunotherapy of into and again a It’s associated local effective recombinant avoids not over TheraPlas before is typically a in first delivery for the provides is regionally today. know making to on being viral of toxicity activity administered carry clearly a cavity be and the delay review take and level period. delivery neutralizing produced is a like proteins of value. interleukin with administration with GEN-X abdomen the because GEN-X for coded synthetic the of a XX can IL-XX DNA for safe incorporates plasmid as immune administered Toxicity systemic cancer GEN-X systemic after patient’s the mechanism. the that TheraPlas therapeutic plasmid Its IL-XX prognosis. subject a to technology regimen is system the of goal TheraPlas activity a technology or or that is for transfect can and to Unlike cancer. cells is and TheraPlas our I’d use systems is IL-XX. advanced regional GEN-X
adopting Institute IL-XX an scientists, toxicity. provides that Huntsville, significantly IL-XX in mitigating developed activity approach of local the Alabama, regional unwanted our improves elegant while Our solution
lasting one local for a accomplished So cell persistent, week. in following of transflection safe, is secretion administration, to up IL-XX durable and effective resulting
of Of they are treated why the with and treated where are me we were XX the squared, the why stand in encouraged? so of we chemotherapy meter treated six program neoadjuvant per were GEN-X the with neoadjuvant Well, dose So that’s arm while seven arm. eight XX of those arm they’re GEN-X the doubling control resection, resections in the of had resection with XX% with GEN-X an arm treatment successful treatment and their an tumors, so Phase in and encouraged. plus let All X alone. a treated XXX portion, milligrams the patients chemotherapy in out a start at do or six having having patients with RX we RX over
free These Phase survival earlier population the of with study, matched due pull that criteria, of arm significance. however, synthetic While has the data statistical dose a a Ib should patients suggests when had data patients -- data and reinforced has caution, be are findings reviewed the from to a now which significant study the efficacy. a patients studies. comparing prior from promising progression in number of dependent when of these small improvement patients These control with with which same to similar inclusion/exclusion lack observations we the with GEN-X statistically
the note, for we Orphan you U.S. the provides following other years the things, Orphan Medicines As final Agency, of approval. in EMA received GEN-X have and I this both XX Designation year particular value Drug European enhances remind from FDA among the received earlier marketing want market that of which exclusivity Designation the to commercial from a
discovery to want very It’s make taking I questions we’re our early our Now won’t on in on and be comments this. we portfolio any on of -- a very phase. few developments
I subject, mention we’re to that want surplus TheraPlas powerful platform the to I So while opportunity very that mentioned this is technology. take a on
advantages. areas, we multiple believe it may and significant a important We’re currently and for with can range application where logistical flexible delivery of concern. combined evaluating payload other patentable provide technology medical approaches and evaluating therapeutic of indications be broad this global and Therefore why, TheraPlas adaptive
on proof-of-concept announce more months. efforts yield in Assuming to these the our experiments we’ll coming positive have results,
Now financial comments. on some I to would like to move
our access our ensured capital As I said We’ve and stabilized our reduce to we early, have sheet. balance spending.
Jeff to Development by planned Jersey now I Now discussed know but recently you this including the want to NOLs, more, approval Agency our moving which Economic on New that will of approved the the by governor. sale were
Our enrollment comfortably cover balance over sheet and several will cash to remains the XXXX, to of enough strong X our emphasize million. runway extend first the prepaid quarter costs I fruition development want time milestones cash Study. that $XX to we expenses bring and well OVATION will the phase of to with
We reasonable access capital to have ensured rates. at
so, our lowers that in product to with For cover debt more a support Reducing restructure with $XX leverage this $X comments, also able we our to terms. million third We less but costs. with far remaining service facility the equity doing with our elected dilution initiatives our loan of substantially provides are stockholders. will and during development quarter, our market $X to Jeff we the further million repay debt which his competitive Horizon loan capital, renegotiated our example, during million Financial. facility August to
X Another Stock of a with the premium announced. to XX% market. point, shares Agreement as we plus Park included with Sale Capital million the That we entered into Common Lincoln sale
a and as we Study OPTIMA of with we consulting III Independent to my HCC. that next. We have is I leaving update discussed earlier, follow very and with conclude study Also Phase projected in is reduced OPTIMA with and The to is the terminate million Study if have am continue at continue patients also the the this overall confounding to we time commercialize the on futility arrangements confirmed ThermoDox up that up Committee over analysis variety diagnosed which primary prepared none the utility the going in situation, company liver cross known finding where not treat negotiated associated to with or for to that Monitoring for observations, such patients and plans change interim planned boundary to or $XX highly newly cancer successfully are us otherwise outcome expenses uncharted Data associated of H unusual consistencies remarks dispel. And puts of or second ThermoDox study’s completely and contracts survival an ThermoDox in we headcount until of decision termination year reduction territory. the should either which fall. may a have our determined and --
been seven for occurred from statistical plan rate near-term deaths period. data of one for it’s second half of the interim over this the with the some deaths Since in X.XXX, we interim futility So needed where when patient XX% which was the X.XX. second study rate, hazard is deaths a XX as earlier a deaths minimum and is XXX. time of July. have of statistician final since our and database the six those ratio consulting lock consistent predicted study XXX equals to analysis, The Kaplan-Meier consistent, have period, This April reasonably now a P reasonably what a enrollment a albeit total final covered specifies boundary XXXX, month the a of of said for analysis suggested We I was analysis of by for analysis. XX, reported the the only but The by of we? XX death total with concerns new are total for curve analysis. deaths reported XXX the X.XXX death with Reported
is is The what basis the are and engaged and In parallel, And clinical Study National statistical of associated consulting, if capability, taking? evaluating management, with a also, data reasoning that survival. specializes trials particular organization independent the secondary contract with laboratory with OPTIMA objective steps the submitted to data to and forensics and biometrics the sciences, expertise a patients Institutes there research for experience promised, statistical behind promised, data all data outside data issues. who determine Now, As CRO’s influences for with futility. from to have are we of Health. a any the and along objective in continue global decision impacted have analysis we regulatory for in to work product evaluation follow clinical unusual may determine and statistical company CMC primary forecast analysis as to
weeks a from receive NIH We the six expect the to to four weeks. in report next back
consultants was of HEAT nor preclinical our We rigorous independent was want might NIH both CRO to have the from independent on to to to conclude anticipated, of therefore, The patients evaluation mid-XXXX. to Study. We firmly report guide the to never cost say published findings from to so recommendation the should decision published supported the NIH continue remarks Study likely to beyond evaluation on will OPTIMA subject. -- final published and that that obligated or undertake of by in the up was of believe, prepared with this analysis, reached a by OPTIMA Study we a do the the independent Celsion consider I and the it XXXX be these research is the the either year, the conducted It data. are science, modest. disappointing. end discontinuation statistical final DMC’s analysis which before few the our follow I quite to July this of milestone X, sometime thoughts support by by the my
from that change, second study analysis, agencies that we interim predicted the transparent we assure At under clinical which can’t the be our is trial the you we may event NIH do. when you we outcome is options the may for with I but unlikely tell said, review in plan any All regulatory do, CRO the we that the substantial may OPTIMA we the we’ll Study it not definitively the choose will conducted. being discontinue is XX this time. be to about to point, it benefit potential at what carefully it by see and as analysis While the
I’ll Now turn those call with comments, over Jeff. to the