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Celsion (CLSN)

Participants
Kim Golodetz IR, LHA Investor Relations
Michael Tardugno Chairman, President and Chief Executive Officer
Jeffrey Church Senior Vice President and Chief Financial Officer
Dr. Nicholas Borys Chief Medical Officer
Hartaj Singh Oppenheimer
Matthew Cross JonesTrading
Raj Kumar Brookline Capital Markets
Call transcript
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Operator

Good morning. My name is Cathy and I will be your operator today. At this time, I would like to welcome you all to Celsion’s 2020 First Quarter Financial Results Conference Call. All lines have now been placed on mute to prevent any background noise.

Following the speakers' remarks, there will be a question-and-answer session. Instructions] [Operator

to ma’am. over like Please Kim the ahead, go turn would to call Golodetz. I

Kim Golodetz

and morning XXXX you to Thank good discuss conference Celsion its call Corporation’s first quarter financial everyone. results. Welcome to

remarks for will XX, Celsion’s beginning practice available later be will next question-and-answer noted operator, by As has XXXX and days webcast on will conference the be and followed call been be Today’s available May and archived XX by the today as website. the the through prepared be period. will a replay Celsion’s

to are regarding During be number expectations those from differ Generally, will this identified actual expects, expressions. call, with be the based management materially and can statements uncertainties, or subject statements in projections Company’s making by No events. on are Commission. forward-looking guaranteed such future can current Exchange believes statements statements. such as similar risks a anticipates, Celsion’s forward-looking expectations periodic about terminologies including be the of and statements and other Securities forward-looking These filings forth set may and results and

this live revise is accurate required made call to law. the the comments this change content operations, particular, anytime of only is conference no significant uncertainty about could of the of XX, broadcast, based May except for today’s during contemplated the and In the financial of Celsion’s discussions. XXXX. that on as update also COVID-XX I of results date pandemic. estimate there and COVID-XX means best Celsion by results and on contemplated or impact caution This call, obligation as undertakes information duration are impact it outlook the

Tardugno, CEO turn said, to over President. Celsion’s I’d like Michael? the call With that Chairman, and to Michael

Michael Tardugno

you, Kim, everyone. and Thank morning good

and Joining Nicholas is for on financial Chief is Borys, Executive few of Medical a Officer. provide Church, question-and-answer in review me portion President Dr. results the Financial Also the Celsion’s Vice call recent Jeffrey who Chief Officer, a will Our today minutes. our

it's you. As to speak always, with pleasure a

many April But will it's do COVID who hard We've recent pre-planned daily and exciting to and news critically our confined are believe number ThermoDox have in cancer epidemic lead with during prescribed healthy I for in home first to of minute. III second lives. carcinoma treatment liver in had this the this primary impact of a I all once Phase to I'm and safe efficacy hepatocellular OPTIMA in both to our weeks continue from remained analysis discuss our term continues newly so. great deal of reached programs, of for our the diagnosed you speaking and hope first that a Study you again, the is or events quarter of important, of more will

regarding ongoing of ovarian development OVATION study, our wave the I/II is of we advanced that patients. however diagnosed a important in reported the currently immunotherapeutic GEN-X, Equally to the X news in positive newly trial being cancer Phase evaluated

the extraordinary position. I've to in seeing strengthen and of we ways shareholder-friendly last positive In volatility clinical our have drumbeat to smartly dose, of our addition outlined month, in steady retrenchment, my the taken research signals financial economic letter shareholders steps as most after to

continue Celsion's events. expect assure to of XXXX, this milestone as know quarter to which second our many fundamentals several like more, extends report about you is cash have I the be I'd past key further talk will and but times runway report, Jeff the as also goal to to our strong. said into during in that we

Our medical advanced poor directed programs clinical unmet large to needs, with patient are populations with prognosis.

talented focus, clinical and with development of have I and the care strategic with several important our through loyal Company execution supported milestones, the staff. been and see utmost extraordinarily with said a to cash sufficient as have programs, We value-creating before, all

CROs it's pressure recognize then and projects. professional not grace to patients, let recognize engaged our staffs their of and dedication team, is under and community that partners, research during and the and this current research the and include know them our the are by for very appropriate members much development programs. our our only them and benefit physicians will consultants their medical by pandemic We their other ultimately who our management So, who to employees the the appreciated, from in studies

OPTIMA Committee or III sensitive Monitoring second events XXX the been of QC deaths date by that the treatment DMC. actually cutoff, I'd like scheduled. interim of lock the committee At formulation has to had DMC. is study liposomal independent The being reviewed our be Data meeting we HEAT or has members prepared. will doxorubicin reached of preplanned the been announced primary our by are efficacy and the the or of Data discussing being time reports liver implemented. for deaths start Data of conducted Study We triggering by ThermoDox studies, recently XXX Phase of cancer. analysis

We expect DMC interim the results to following early July. in the report meeting

a for study on and Study and the a track believe Now, for Company for belief hazard is success X.XXX. data for remains the success short, the our our is X.X to The success that, are before, our it's P-value this I'd success blinded. hazard The course the is OPTIMA the success. X.XXX success for that into OPTIMA is data Supporting of respectively. support based on. the for for analysis, XXX and belief said was events you ratio as from that respectively. ratio threshold comparison P-value to X.XX insight I very potential good of at some like not there's the give we but

repeat, more upon to XXX hazard protocol Study the subgroup for patients when X prospective the a overall to to favorably from I and Why the the the based. death months. observed was time the half HEAT was HEAT Study compared At two to and to prospective, prospective median ThermoDox, year only demonstrated for studies dose in our than was Phase controller advantage death P-value which compares seven remarkable Study earlier of years. say a OPTIMA single remarkable? expected from ratio do This conducted, a the time XX subgroup a This with patients HEAT median survival and Study, treated of be the I time

single by were the review They hypothesis XX% ours, confirmed the for and the us saying NIH valid. trial HEAT that's what of subgroup this is different of that for is of at all a XXX review independent not of trial in account HEAT The of the Institutes the patients data. throughout asked National second study design they to analysis the their than success over a seen thesis this concluded request, by Health. in the At subgroup, of data that studies, studies population. optimal slice bar with the a lesions the was into kind we’ve lower institute's Taking again, using independently, the summarize supporting by subgroup validated prospective

necessary, a bar So, the necessary, patient the analysis third X.XXX If regardless, of in Study final for we the and I XXX to on it's receiving is success than hazard we HEAT well OPTIMA is that look for lower. necessary The believe potential lower the it's positioned success, ultimately respectively, anticipate forward which positive occur based be DMC's point, deaths. the final and if analysis X.XX, even At observed prospective outcome and will the final P-value ratio Study will XXXX. a the far will on at is are however, first for recommendation the subgroup. be this in analysis, the required values quarter if

direction. Thought that leaders our community you Study remind validating again underlying subgroup is have HEAT the supporting reviewed published of in. results, and confidence the OPTIMA hypothesis also including distinguished Conclusions all in the the manuscript pointing will data from from HEAT peer published hypothesis medical OPTIMA analysis the the NIH again, I hours of not and Study preclinical long. the scientists supporting in any studies support manuscripts Study, weighed public the is same

the too combined the PFS death for And Study disease with both we're the been encouraged the I’ve HEAT further in COVID comparing Study? the almost out weeks includes to plans extra line a of ensure the which are and perfectly has DMC. at look current pandemic data presenting timeline input which for accounted all the I'll current affected few July for to in studies prospective meeting that progression. of COVID-XX asked, our OPTIMA patient of the virus tracking point rates, before we is and DMC impact subgroup, our trends that clean

the virtually make or the place. the conduct countries the than able in meeting, delay China some were had restrictions call. many that on no sure had DMC Otherwise, largely in to the some the of trial during impact the discussed monitors to We was despite impact. an patient coronavirus all few follow-up restrictions the our where clinical visit -- were for We extra weeks the the very and study monitoring, the virus the appropriate short other in monitory took of world where sites of restrictions complete to this from being the hospitals being has due of this has areas just for monitoring last the other of a conference

go I to want on to GEN-X.

our we trial is immunotherapy dose chemotherapy compared advanced patients. review, X ovarian to the at evaluated of Study, this There arm GEN-X cancer development XX% the chemotherapy It's Phase and is of talked now in I randomized running per diagnosed I meter study, of a neoadjuvant a Phase the as advanced alone. I than combined squared, study the about. TMC portion newly said control the standard I/II with the care, a continue candidate milligrams for we've prepare a as of GEN-X, we first GEN-X. neoadjuvant While Phase higher being OVATION stage concluded that XXX we In

on and X evaluated. arm, X arm, I and study XX been patients Phase enrolled X included control This have those treated treatment the patients, have the on been

a now of patients and to up Phase in patients trial. are program enrolling XXX XXX to forward the II II for in Phase We this total looking additional

of technology. to a those GEN-X for cells means for with of background engineered a new is TheraPlas, platform are TheraPlas nanoparticle name delivery that proprietary implies you is coded our for value. the therapeutic system proteins transfect plasmids As as to using gene non-viral who Celsion, provides

interleukin the is for GEN-X gene sequence ovarian treatment. XX such body as for into a peritoneal cavity incorporates a IL-XX. It local administered or cancer regionally

of of up the of up immune durable, immune cells secretion is secretion body's a Following has accomplished means known entirety millions to the a to malignancies. IL-XX week, be in and system, administration, IL-XX the the effective the of fight system, protein. cell among has as persistent, week well recruits of one an to millions switches transfection of of the to immune system master local proven and resulting

GEN-X of again of recruiting our administered over ability or over may cancer the the cycles, that, beauty Phase the to a escaped is technology administered goal be system of in repeatedly of and to is durability be the week this The ensure said weekly cells XX of and will and immune it I immune which neoadjuvant have response to either sufficiently that surgery system II is in treat Study the chemotherapy. that active

results I'll effect. that that, mechanism talk an suggest having is about Initial this more.

safe be XX treatment surgery, ensure particularly follow-up of declared meter a XXX steady As for at mentioned had of the debulking patients. maximum part I GEN-X safe, protocol doses regarding that, is required of February, continued recommended news during beginning milligram the to the which stream per following a to call, and DSMB quarter. is encouraging dose In these the protocol we've interval per the the are

per two from the and next meter continue fully of evaluation dose squared, news-related Agency. approximately XXX profile a safety to II Phase recommendation expect in a positive will GEN-X at Orphan due to Final ovarian milligram to XXX per by another We DSMB the our be In of partly and Drug European Medicines therapy. weeks. milligrams meter status cancer March, was GEN-X the in granted very

quite an of data of it early both trials. efficacy not accomplishment, in sponsor just sources granted, our to as You it's a is a as supply some demonstration from incidents of may phase so drug know variety this requires well

things following in with exclusivity GEN-X the I designation procedure. It a authorization EMA’s It following the orphan authorization reduction approval. to value from provides this protocol all both FDA, providing member It a for to exclusivity other and also become very -- immediate allowing the GEN-X. of -- us very want very a eligible assistance. marketing that regulatory important designation EU. of gives The for of of positive note time received for from regulatory marketing access fees. approval, of the provides years is previously is It states XX market the all us would X-year This among of for manifold. centralized immediate

highly now In of with survival treated being tumor I know encouraging synthetic study In the OVATION-X. mid-March, Phase in in survival. patients an control Phase findings reported response may scores that portion to pulling OVATION-X, of scores, predictor Many highly a a versus our The progression us XX Company we surgical and reported I world encouraging synthetic from were of OVATION-X surgical that dependent statistically data prior dose improvement validated is overall management. comparing a leader patients arm. They're late-March, by provided PFS The clinical Medidata. arm name. free you is data OVATION-X control a

a cutting the that's to to is of which arm Medidata trial in by a or a approach of control for strategy. developed clinical all This The being edge is provide patients clinical trial. goal a replacement some

synthetic arm we our we XX almost we the patients, a our treated this when saw that doubling synthetic control hazard in patients of with ratio a the control doubling, a in sorry, time study to ratio I'm of the was arm. the GEN-X to median While compared when over while for X.XX progression hazard I Phase compare patients

As stand It's doesn't published it alone. experiences. said before, prior our clinical Phase remarkable, by data from I is impressive and with translational but I quite this supportive

we surprised other by translational weren't So, surprised clinical to action due the Phase I surprised our of we PFS or are outcomes largely data that experiences. magnitude. that weren't all the the and mechanism in from seeing We improved,

consideration that cancer with diagnosed strategies my strategies to a excited the and very ovarian in want cancer, hear strong the past. these development in believe we're we we’ve ovarian data. for advanced you and by them newly So, for with clinical and they I the accelerate program about discussed hope that GEN-X for voice FDA patients

data We of we encouraged a on on XX the point are based you the brief not outlining FDA results the these expecting response agency's our to have data view. to submitted this next XX the submitting brief a post and -- I'm and based in to I'm days. on

as be noted All for modest. worldwide I'd do need show call, to a is in development lucrative the a work. foundation the is efficacy in I modest delay point we're all, that in building believe an Well, continuous we suggested early plan there say asset GEN -X and what earlier work, to out, I should and being

program anticipate on assessing pointed or to would to I impact situation year weeks more than a over we end six as few the approximately did COVID in if that months. out due issue. Well, call X II past I we've decided months. by the evolving Study to our to During pointed out, X And Phase that significant not March, delay delays, X the not any our of GEN-X any, OVATION so, after the the portion amount

finished quality of the meets and product, our Company requirements. to due out a made assure largely quality our we This investigational by delay because me made specifications meets the ensure the an is of abundance decision by that to product of It's caution. product our our

COVID-XX-related that our with ThermoDox manufacturing true the strict in at facilities travel unable organizations, technical and to have their visitors this restrictions resources on our these contract limitations factories onsite we've formulation facility GEN-X, We as always as this during in But have mandated we present well by with product. be scientists the manufacturing our time. were for mandated some the runs to manufacturing always of that's manufacturing

that may to incumbent decided manufacturing our to I've delay be have product us postpone to make to treat until we September. investigational that, can we present, up upon It's sure patients. So, be available

next until out again II decided has few initiate abundance to not in have months. caution of we the of manufacturing So, resumed Phase

scheme, GEN-X a the success program. not in be said, this is success. just material the to this it's our of As for frankly, production overall and cautionary But are -- few months good I practice material would

it caused enormous an So, delay.

patient accelerate Meanwhile, we're looking for to ways enrollment.

So, study only have any months on impact may this a if few delay completion. minimal

the commence OVATION the early announced in So portion had second, XXXX. now quarter, that X guidance portion we second of previously Phase quarter, half the in is II will where commence the guidance will be to precise, that, of II the in Phase fourth the fourth our

elaborate of justified $XXX,XXX us the than return our for to want of made also what I loan to continues under and loan loan to SBA payroll The of release. yesterday. protection late after understanding very the application Act. as CARES was consultation to the become Congress that, was with our intent as in press to the program evolve believe and We administration with But of included our counsel, the us. on guidance consideration it and more the clear me clear consistent qualification some increasingly

from recent the some from not gotten but SEC. the guidance we've SBA only think I also

So rather to the Company provided fact funds, the the decision yesterday. uncertainty occurred U.S. after the by Treasury is deadline to that return the subject, Department than decided then

deferral negotiated taken $XXX,XXX our offset through documents than other to we've Mr. cash actions the than government. modest Horizon financial a renegotiated principal more that steps for adjustments My here to under offset, reductions, Now of offset we've payroll some and are example here, Loan more that Venture impact this compensate, once deferral flow. taking temporary payment has the and -- Church colleague may to returned to improve the signed we're the

achieve we everything Our quarter of many cash in have before do that, end ensure to runway that to that happens. that the I've the times commit the power ensure goal we our major -- I many as of through XXXX. we is quarter, repeated just will milestones expect always, And to second you

no have recent saying I've in company's orphan some for in resulted have day as show few significant time immediate regular designation fact been your stronger, from have drug quite we encouraging, which our agencies a GEN-X EMA. been issues as meetings regulatory each in various with points with conclude I'll now And and sound. So turns are what on fundamentals for here our been grow

strategy as be manufacturing solid. Our can characterized

pointed Our end redundancy focus as in during last has on pandemic this well, us served year out I discussion. our

cost enviable the the is promise no market with goods margins, costs, of product our Our of matter or the high gross region.

China life frankly, ThermoDox that's for in but HCC lifesaving gross to worldwide. margins, goods, provide potentially more know this ability Asia, importantly, where a the good us malady patients drug Southeast poor highly countries, to HCC, cost example concentrated You that addresses in of low saving assures

point I'll been have investigational standard Study products, investigational market As again. and cash management measure. of have our generating Jeff important two with of conclude will this blockbuster of point our Each focused products. cost by OPTIMA in the said and out, our transformational each potential it results. spending tight two The over or I've is potentially on and anyone's

patients, our forward have and product focus confidence will with we most that the looks every in reason our XXXX. to A medical of our Despite and year technologies, turmoil, our transformational community COVID-XX employees. balance for investigators Celsion collaborators, our investors. We have the to trials, our the and importantly, be believe every laser

Now call these to Jeff. the over I'd Jeff? turn like comments, to

Jeffrey Church

quarter Thank the you, XX-Q, today and Mark. Details issued included we in press felt in we before release which of market Celsion's morning this open. our results Form XXXXfinancial were the first

compound making than the capital we're stated, on tight in which as prepaid cost weeks and of review, less tap both to the recent interim about to the and second smart corporate we As for abroad. important U.S. occur a Mark while been into We've in accelerated lead able we've all adequate of near is two raising careful clinical on months. also milestone expected In our sure goods in progress keeping meantime, the kept has as our eye of data expenses. control supplies

million. were Celsion's interest XXXX, XX short receivable term and march investment, cash, the As $XX.X

monetize the were balances In from operating million. bringing of our receivable to addition, sale which cash $XX.X April, we net Jersey a $X.X in million able our New had losses, we State of

$X first of the position the cash end in offering at February. quarter million includes million quarter, net from direct the and which stock of equities end $X.X the sale warrants Our registered proceeds includes price of during from

OPTIMA balance have in Study. while the complete price our sheet current market the against erosion strengthened face continued share to we public buffer opportunistically of our potential We the of for uncertainty

NOLs will quarter the through XXXX. plus second extend cash their of our runway current sales future plan operating Jersey Our New State of

quarter well the this OPTIMA Study, XXXX. Importantly, during readout data beyond is would of the occur final the if which of first needed

X.X million raise. in cap at the includes of the with million warrants XX.X of XXXX. Our September common early outstanding X approximately exercisable associated these $X.XX table and warrants, equity shares February are which beginning million These are a warrants approximately share

share that a in Note file the exercise our million to these warrants one the flexibility, shelf extend from price with capital now price way. $XX on to quarters coming may we cash With funding registration this future above to additional respect further have is SEC. the provide

We $XX shelf. on have that million left

commission. facility raise facility use a and have with market traditional The no us to a allows also of under at with JonesTrading is We that control. very the opportunistically entirely our money words the low ATM

quarter, Turning of results, a were first in million expenses quarter X% represented decrease which out financial first XXXX. million in $X.X for the operating $X current the the quarter from

year. incurred XXX,XXX quarter, option During the $X.X compared in the million non-cash expense prior current we in stock to

and compared first Research its XXXX, $X.X the of development for in were in clinical expenses first expenses million the to Development XXX,XXX the Study OPTIMA were $X.X quarter up million quarter XXX,XXX in patient has August enrollment XXXX. follow-up decreased of phase last full after the was as to expected, the this year, trial announced moved year. These into as costs compared have

OVATION X follow-on XXXX. study of compared The portion Expenses full announced trial in XXX,XXX last phase to first of X of with Company in With to period OPTIMA first in September year. phase this increased of Study associated the half the one same quarter $XXX,XXX the to of completed XXXX. XXXX, the the the enrollment during initiation one

reduce this compared to programs implement $XXX,XXX continued GEN-X. of year, to TheraPlas $XXX,XXX associated for capability the Company with last as first GEN-X year to the expand manufacturing its activities and to costs Expenses research manufacturing development for and in increased quarter and

and was attributable on compensation, of XXXX. XXXX, decrease $X.X in and partially to compared first to were expenses offset by other stock costs quarter quarter the in first the million our premiums personnel increases This expenses of General D&O XXXX. insurance which in primarily $X.X to non-cash was related for lower Administrative XX% million

the charge amendment earn-out per Other ovarian for of of of GEN-X during of quarter $X.X in the to with quarters investment valuation a milestone payments the candidate. Horizon, with net from first the a in The XXXX charge an liability milestone compares change realized expenses and non-cash in for net issued for quarters $XXX,XXX $XX,XXX cash related a GEN-X and million for debt connection earn-out and included of This warrants year. venture at last $XXX,XXX cancer during the term both $XXX,XXX gain XXXX expense in facility short a XXXX. of first Company in XXXX our of first income interest we incurred interest both to

capital that $X million anticipate Celsion is sufficient in calls will for the million, at of approximately quarter. line quarter the year second utilization second the XXXX full net XXXX, and usage operating quarter. quarter our keeping to second approximately operations In usage with quarter we which net XXXX financial $X.X cash per their expenses the anticipate We be excellent will $X through of of cash be fund with cash budget or per of million our second approximately million during summary, half $X.X that shape for in is with during

significant for as a for result believe the a as will well In closing, opportunity opens inflection Company billion in outcome and market clinical to dollar point our shareholders. ThermoDox we that successful value up

Mike. I'd like to call to the back turn

Michael Tardugno

done. Well Jeff. Thanks

Development of memorandum last from in the Company we remind significant provide officials signed financial of establish that area I understanding call Hangzhou. the Yuhang questions, with with year of you to to The want the to Hangzhou District I'll the all subsidiary a MoU, you, open remind incentives. we Yuhang Before the Economic

China's the priority. the is for address innovative is ThermoDox. to needs commercialize has that government technologies purpose development this starting cancer of biotech unmet medical of located Chinese subsidiary one a where therapy area advanced The made primary subsidiary of in hubs, The patient with high

the will markets focus on Philippines, all and China, subsidiary the nearby Vietnam. Malaysia, addition, Thailand, developing including In

provide of cost cost geographies. established Hangzhou by cost has the is an structure is to in has for these manufacturing Hisun, for viable if establishing name it, These our completed. local low subsidiary see expected of Celsion partner English, a economically production a you subsidies been ThermoDox Limited. Pharmaceutical Registration and low

Best we've I said HCC. drafting, ThermoDox begun and NDA for the for NAA point, Europe and as

to the filing is goal within prepared complete have OPTIMA Our six the months of for sufficiently both to Study. a unbinding

second to the from example, we around active hope interim a investors, beginning, by would filing have time. announced with in For very we if analysis albeit during of July, the beginning XXXX. positive the made telephone remain data We this

re We of many ahead remain as year. this exciting have we will so continue to us milestones so

questions. the open we'll that, with call And your to Operator?

Operator

At open for this Thank you. time will Instructions] we the floor questions. [Operator

First line is questioner, live. your

Hartaj Singh

was It's Jeff. apologize. from I me. Thanks I be did that Oppenheimer. not Hartaj Singh to know Mike. what Thanks supposed

following through kind all expectations for Just work good that on is doing, on do question. we on company that know couple think some of a all quick of the had every understand the that's and A delay questions ThermoDox the way, congratulations you're almost set that I and we then GEN-X, you impact. and the COVID-XX by of having

talk OPTIMA can updating And could with Thank take What then OPTIMA get you bit, the got years. Can when you've I PFS, has six blinded and NDA GEN-X. limiting changed months that couple you. steps? the be specific the talk So, things Study? successful? the to on a did you the specifically couple little just of are you ThermoDox is PFS those about dropping the monitoring last working, successful. What XXXX little since on a a also that talk to how of assuming investors about the MAA, for you've the that MAA filing, rate last interim been interim, blinded been follow-up And over first while you interim, that early OPTIMA you the are quick bit the you this assuming

Michael Tardugno

much. very you Thank question. Great sure. Yes,

comes the regards information most with analysis. to the from the recent first interim blinded So, data, PFS

XX.X subgroup, we two that the from pulled comparison saw that don't do patients, when the the it patient may for progression two prospective Study of to the So, except, in When subgroup, we the XX.X arms is is OPTIMA median X time we time presentation XXX together accurate, analysis, arms pull the that, the for DMC. arms otherwise current except XXX HEAT progression to to not months. we months. In median the be Study,

So, each of they're top on virtually other.

hazard Kaplan-Meier it for and the study that showing We Study these they're for overall in and recall PFS HEAT two-year OPTIMA the what basis to marker exactly. that XXX patients but OPTIMA as see We that in the than has the the falling threshold, Study, a for success as the threshold we Study now saw a we we group, So, survival. from from lower that generated subgroup. higher than improvement ratio, a compared are falling lower the P-value almost is was

So we're encouraged that. we're by really encouraged,

and The the steps believe I filing NDA. for limiting think, of was the rate it I second one

with with So, activity do much the rate has of limiting FDA, to engaging the Hartaj.

like this a were the to meeting some give top-line positive the We result the would have the DMC, We FDA call formal a submit we outcome then meeting. would a a So letter them. the FDA. have would with have them a we to of we immediately from to place positive tomorrow know let and pre-NDA that, FDA have requesting idea to we to

sure letter we drafting make as And to right the bit we're a It of little speak. time takes asking that we're questions.

NDA. in trial. meeting, days meeting takes from questions XX along cases is this top the the meeting with some of series a line that months. pre-NDA can of half and XX we about have two data So, days, Scheduling usually accompanies prepare time the FDA's they're another of what the looking finalize for Once, the is we understanding probably then the three to which NDA, almost to

Hartaj Singh

I and NDA specifically sections, or CMC the know, an just would preclinical have three of MMA Great, Mike. just clinical. then in And terms right, on the an that,

and good section mean, need are So, CMC to preclinical that OPTIMA trials your the the I the really interim the section clinical go, regulators, for and discuss with results It's assume I from correct? be second the while. should OPTIMA you'll to a going

Michael Tardugno

should that. I Correct. have Yes, mentioned

and CMC are So for the complete. most part, the sections preclinical

of So, in it. matter a section, haven't critical the just narrative for draft. we It's populating the

Hartaj Singh

which against really is hazard good was synthetic interesting. And GEN-X, that Okay. then study, the on I have you noticing control those ratios

way future had see X.XX X.X small and dispersion? as I reflected see a above the P-values was will dispersed a X.X. being that like happening? you ratios The X.XX, was, you why it's and But the were of all Why trials or question to Is the clinical what it just think the from up at little hazard the X.X. those. for such When or one I ratios look in numbers did big of hazard that? more reason was

Michael Tardugno

P-value is… not that was I'm we understand sure X.XX. completely. so ratio The question hazard just The Yes, I discussed X.XX, the

Hartaj Singh

are The wide, that right. confidence around intervals pretty

So, that's coming where's I'm asking, from? how that

Michael Tardugno

I'm think it's Dr. largely due insight? to any numbers. I Nick, Borys small have do you

Dr. Nicholas Borys

of Yes, focus that's in relatively I'm Aspen type this ND with the discussed be ratio. told the People correct, it's hazard -- Mike. sorry. group, to said from P-value that that the analysis the they When statisticians what the statisticians, that I due really this me shouldn't

So, we ratio [technical think that hazard difficulty]…

Michael Tardugno

a Nick, bit. breaking little you're Unfortunately, up

Dr. Nicholas Borys

statistician the our agreed with a the, the in-house and from Medidata, number. to that both I'm was and P-value sorry. due small statisticians We talked they

Hartaj Singh

And suboptimal Is they they why purposes showing designed that a be the ratio, that just patients know future hazard good relation Why be hazard concern is to study, you've patients really -- show that had to the Great. is why able dispersion the any were kind of interesting with a only will such? see hazard got arm hazard if possible? X.XX. you'd Because, performing there my but synthetic to wide, a a you I as from pretty poor ratio why ratio, because were then some had it kind is of if ratio? again, that this for of control

Michael Tardugno

fill want Nick, you that? to do

Dr. Nicholas Borys

with where it's And a FDA. closely patients phase XXX to start biological next work cancer. And think a our see think you'll a that's why tighter study the stronger I study HR. the is Yes, we I address, as variability a currently, such will P-values in seeing that system, important which all that's at

Hartaj Singh

will need And to lots? produce you fact, want other for it I therapy. Phase I able always manufacturing the companies. need the on last manufacturing quick are My site question Where for is. why the most the the we've many that scientists get all mean, thank you lot which all But maybe understand have scientists I just to Great, you. II? OVATION site? is And the just Thank will then question. mean, of question you you talk an about at lots X this to is to with you in appreciate lots. if how meaning, have formation have Can you our companies, you one manufacturing your order of I right. these completely with want campaign? be questions. that. formulation specifically understandable. Michael, successful, I ongoing in to And a seen be do delay, issue, It's

Michael Tardugno

Yes, sure.

able So, we small scale the to be supplies in sufficient and manufactured within FDA the batches size relatively to clinical limitation.

The to the quality clinical clinical properly size, scale through we're assuming registration established that batch validatable that studies. able is the its that the infrequency supplies of issue. engineered, batch then manufacturing times it's has has clinical size it been XX So, and

regular, Phase would commercial regularly producing if produced records. course particularly batch product product no minor But produced in are to cases, a the we are II. I and at the in supplies I Phase When, having infrequently. hesitation many clinical a the of adjustments without is made have manufacturing, That were by there And facility. during person CMO, of

of kinds months as people months some XX the products companies But an individual months. these manufactured maybe So, or an of they're many this. six it's knowledge time or This a to their a many, we part. think whether infrequently is multiple, are all manufacturing function exposed the and not of it's nine manufacturing, my on think important important, they to obsession in during plan -- have do lose time, because many, is we

that's sure every year. that year takes important to plasmid experts It is a issue. having gene this therapy, or losing particularly about for site, that manufacturing, manufacturer for about but infrequency us, of a almost it we are sponsor not a taken So includes simply assures this due Historically, our takes year, or a on us to some whose product for it's make product schedule GEN-X, not batch. a yet. And a

cost high it's requirements Even if out it's small a fill trial. don't batch So We had waiting not a and risk take. the show if meet for a we subsequent our requirements, a very of some be we had of the did We finished at risk, plasmid the a just -- we a dispose that can were would we it. clinical long away. And manufacturing, consume to for we that time our to that's risk. product to a in think

Hartaj Singh

lot no, of lodged you Yes, a actually makes And that sense. I Mike, for it.

that's agreeing. to Take July. very think a I care. the Thanks all for very part. on your I'm smart I'm looking prudent. we're forward questions

Michael Tardugno

Hartaj. much, Thank you so

Operator

Our next of question from Matthew JonesTrading. Cross comes

Matthew Cross

First result the given off, may that like OPTIMA you about start here I'll we time talking that I program this with a may guess, next hopefully. sounds be it have positive

just to wanting of plans previously China. the so kind to in Europe places wanted of spoken to internally, in And out reiteration your you've things and like get commercialization, I and regarding know handle a U.S., partner

OVATION of Was account us look more maybe parts dosing you to is potential taking kind the maintenance of that novel wanted because to have you two relative remind I then the second plans and given, from the that could Just the of changing any X to of dosing to X, landscape? of confirm And of through OVATION-X? positioning to this portion, one exploratory kind one follow-up and latest term longer phase into might at benefits to GEN-X. OVATION particularly hoping maintenance COVID on to get portion was the speak kind phase read some of ever guess,

Michael Tardugno

you. Good Thank questions.

don't So, the just any in let of affecting see the commercial with you COVID situation our start ThermoDox. me I plants. circumstance commercialization

it to from the be the positive review. months before that's gives fast a you track, other track biggest FDA of even of study you're companies, or months launch. XX regulatory from consider you As product, XX to prepared a XX the timing readout priority to assuming fast timelines the the a for XX agency of to could And launching a that

and got better better So, be will more and hopefully, ThermoDox. the and a out community managed, just year persisting half provinces not this and if here, for than it's situation understood other medical COVID we've by

the close to need medical Highly remaining pharma million largest addresses This is a that's drug strategic the China. in By time worldwide. oncology. most unmet right market there focus this will and in the for now incidents ThermoDox big be concentrated approved,

literally treatment no options, no of potential options patients. imagine the have for pharmaceutical So largest the XX% being of largest medical drug therapeutic diagnosed with but for planet with China options the global newly market you newly for unmet can the patients. diagnosed incidents on They the need

to very when deal blockbuster, Jeff of you this population. business globally, great drug So And conservative, it a at a are our for particular there's out, look dollar market. pointed interest plus as mean, models billion a I

with any sales So and launch have finding the difficulties we're marketing prices choice strongest I suitable we capability to organization. them, the diversity I we'll don't our optimum to best market with that product think going we're all that this have at saying, have partners. the who I'll believe the given sure fastest really, with and I'm have the mean, partners penetration

ThermoDox United States. for ambition stewards ourselves we best handle we have. can That's in to market States. the bring ThermoDox we'd the We be to however an -- mentioned, we in that you've the As are preparing United think

However, it's important going think I mention. to to but sound it's trite,

do what's terms reduces penetrating this gives a some point. pricing this there's will expenditures then and at research conservative and both certainly provide for made market opportunity with as investors, research we But, cash. licensing risk We market risk, better what for than If the have return no see to We're could the will shareholders. consideration. improves in we product financial best our that company a an that important launching other the we believe of and

have we outcome. So, positive

the out market in more in turn quite finding but to be we'll developing ThermoDox marketing our U.S. to best aggressive However, the as for to in in the may a lead race U.S. approach, horse bit the bring dark a plans the be strategy

recruit the to current to some I your we frequency you're regards over in maintenance continue therapies time. what full system treat immune the with assume in cycle a following which talked schedule, some continuing question and GEN-X, about of longer to treatments period of have protocol to the talking Well patients, about is, on

sufficient have on program thoughts consideration line. I a in patients anything. I think Do very look it that's how mean, present haven't Nick, doses our on But the for beyond at might like interesting explored we this maintenance you any a point you're study? strategy. that XX any the with

Dr. Nicholas Borys

I nice very and pre-surgery, that a that has profile, the nice GEN-X. in proving already a a the now we're safety bulky has opportunity disease proving We're patients both for Yes, safety have very profile. agree. It's drug interesting that drug post-surgery

it at So, is looking very as therapy. well-positioned maintenance for a

it first further that through control on all keeps the that we're opportunities we're the data there from establishing synthetic if suggest. seeing up the seeing now, lining are as way the right one, our if phase data So, you

Michael Tardugno

third-party add And to home Nick a pre-prepares a has kind demonstrations developing for I'd of health just Nick's approach. been home working ID type care administration. who with a instrumental point. been in We've

some this where So, up, really the throughout patients be GEN-X to just the the fits would strategy life this a thinking about it broadly, that of more administer potential course into commercial perhaps. nicely rest frequency add required of

Operator

Capital Our of Raj Kumar Brookline Markets. comes question from next

Raj Kumar

for thanks questions. my taking Hi,

to terms patient are continue long Are and seeing any if in further XXX events be expected? there seeing are to stop what follow up? And expected you because tests, situation? you patient you efficacy, the as of changes COVID-XX for of will the regarding the first, trial followed need So following up this the how

Michael Tardugno

study think is question? I successful. that the the Is we patients? stopped if you're asking stopped Will trial and Yes, following the

Raj Kumar

of if whether this any kind be there how or COVID-XX of sense will following you be long stop situation. Yes, because will patient follow you the of changes whether following? you And

Michael Tardugno

strengthens But that impacting you Nick, follow think a is see ask COVID I our do view that But the and studies FDA, hand. want this don't survival, weigh that I our to that's patients we'll all, we of frankly. to OVATION only I our will on question or at continue that? point in Yes, think for

Dr. Nicholas Borys

regions Nick Boris. Chinese continuation also remember, the are I And as Europe. of China the submit FDA. or some the presentation, take And may Yes, to agree other well. patients Mike counsel in also looking authorities mentioned to from see as of going in is this earlier And their that, we we're to and want

to best authorities So, whatever us. that open regulatory leave to the and to indicating we're are whatever going option sciences the

Raj Kumar

regard we'll GEN-X, reinitiate, do the you think Phase comfortable be once to start with to what at time point you II? And manufacturing,

Michael Tardugno

Well, to the potential as setup the of we to times. a be and in we don't of I the dependencies see provide don't at soon as is some person failure. facility start It's just to manufacturing that the the knowledge, any real matter having manufacturing, that assure time a want guidance, overlooked. correct institutional dependencies There's temperature

So as soon as we manufacture. are ready to

put it be as So in facility, as a could we early a September. person can

will program. We II Phase the initiate

Raj Kumar

screening you patient. And the about also talked the continuing

And in Phase so think what once bolus that do you of expect resuming terms the time at point of II? patients of

Michael Tardugno

model XX we model have The Don't of per currently one We the suggests XX. close we patients. is a number hold I have XX. per to developed it. me very sites recruit site. experience can approximately patient have we little that expect to that activated believe recruiting with now we XX. bit are month to a so Yes,

in sites. two just those and a to on kind -- U.S. is XX COVID initiating of to slow those, in more here, balance We're situation to expectation enroll Canada. in Our of the up sites walk given the this

begin of site. would we once II Phase to been patients I that happen our the shows so month model said, as very But initiated initiated have about is per And could quickly per we once recruiting sites that study immediately. one again, patient -- the all expect

however, investigators. can and And don't us. momentum that's be among enthusiasm we that big lose problem for big a meantime, want In our any a to the

company they a it there's modest this effect. but an the could So is know delay, that taking position have

of on Initial operations be So investigator that II. Nick and initiating people have will as meeting an organized clinical cusp the Phase

through go everybody goal the protocol to one more remind just The requirements time. quickly are, was what the to

a any losing have any from three limited see we these few very, I lost have diagnosis. one patients So program when how the life physicians, than years span. knowledge more they of very that who mean, of be, patients should haven't expectation of

it's And among together get the grim. So, of we've similar for it's It's I our together, investigator we that When really, they product our get each they is seen other kinds generate in this. trust meetings, extraordinary. grim. these enthusiasm mean, when and

here goal investigators. continue our motivate to our so And is to

sites good a are number to go. have We that of ready

be We'll quickly manufacturing once been more off can. we'll a initiated. adding And few as has thing sites, this as we kick

if patients arm is discussion I don't we all think recruited control of them. that there they control organically But outlier of with with of to arm with is substitute not patients, our and patients, agree the arm we'd us, some synthetic part know. control like one that FDA

get or quickly. its number group, XX immediately if XX% arm getting of could from that the control the But recruit could have replace the patients, into that the that we patients we trial the would accelerate to it and would of study reduce XX we a in arm be the would a big little to more patients If control completion. boost synthetic while

part of So that's the focus.

Operator

Okay.

comes [ph], question Private Our Mitch from next Landgraf Investor. a

Unidentified Analyst

getting Thanks be weeks for I'll regard the when extra for all investors. correct information few to individual calls question, for Mike, you're making that OPTIMA from try One the the in was sure taking submission the that wisely taken trial. to brief. were

the that separation two I think there few Just be a Or would those actually chance provided weeks extra our curious, arms in more is already bit data good of a of little was which locked? case? time

Michael Tardugno

patients died. remarks, the the XX allow reviewing evaluation. maturity I and extra be Yes, think number the few my few weeks yes. the -- more prepared I more in Yes. DMC patients. patients patients more few said will That have a so is as that A into was a The

Unidentified Analyst

bodes this awesome. interim for increased at actually be would that's success even well coming interim, slightly Yes, likelihood of which

some I'm be Finally, meant that kind anything day, Church. afford just appreciate seems or somehow private individual past investors. take being of not is own be to that can difficulty feedback, to or that individual with questions in. are to from opportunity website. do used technical for channel I sure isn't the company just these not the personal on investor, investor of and working. calls a from that's That that thing investor complaint, a communication response portal there's every non-material any web that to appreciated. share getting again, the also There phone I a to submitted In that even retail Mr. through direct be it's And my just experience other limit a everyone not if issue individual do you questions to than friendly to that that questions you investor get feedbacks two advisors on also would financial to to the calls. retail

feedback So to the the that and change, didn’t somewhere breakdown. that there's a want to something know or in as if Company, address communication quick that's just you

Michael Tardugno

I of for much. pointing into aware problem. particular not Well, was it it Thanks out. look any We'll

Unidentified Analyst

I well, best all. to you thank as

Operator

today's I'd And turn further to questions at back no the this over in queue. to time, we have like it speakers.

Michael Tardugno

doing in such we're of we again the face-to-face. during lives could this morning, hope excited make thank patients. that while and you we difference call will you well interest COVID more be before long, Company. some huge prospects seeing and Okay, work cancer results that And pandemic. what to that be you health all for your your I much of time the very in the a positive But wish This we not our

Stay safe. Thank you.

Operator

and Ladies gentlemen, today's Thank teleconference. you. this concludes

You may now disconnect.