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Celsion (CLSN)

Participants
Jeffrey Church Senior Vice President and Chief Financial Officer
Michael Tardugno President and Chief Executive Officer
Nicolas Borys Chief Medical Officer
Khursheed Anwer Chief Scientific Officer
Hartaj Singh Oppenheimer & Co.
Call transcript
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Operator

Good morning. My name is Chelsea, and I will be your operator today. At this time, I would like to welcome you all to Celsion's Third Quarter 2018 Financial Results Conference Call. All lines have bee placed on mute to prevent any background noise.

Following the speakers’ remarks there will be a question-and-answer session. time, to like call, the this conference turn Mr. At over call host Instructions] I to would the [Operator of the Jeffrey Officer Financial Church, of Chief Celsion. Mr. proceed, Please Church.

Jeffrey Church

call welcome Thank which results, yesterday closed. our you. everyone, market announced our and the Good investor quarter morning, we conference to after XXXX discuss third to

will Borys, answer Tardugno, Celsion’s Officer; Medical and during Khursheed Anwer, Mr. Joining President Chief Chief today Michael are to Executive Celsion’s and Scientific be Officer, the Q&A who Chief Chairman, questions Celsion's Officer; available Dr. Nicolas Dr. of and the Celsion's on available as available and call. be portion XX Today's conference available remain a beginning website will call for will by archived, November as be phone XX until replay days. will well tomorrow

turn we call will Commission. uncertainties, questions. expressions. guaranteed, other that forward-looking call, terminologies identified At a and Celsion's set to the Exchange in periodic call current statements for expectations my filed of inform today's we to from the such events. and about end to regarding those the over will with statements may be and expects, the Securities It’s begin be and are can number we forth reports forward-looking expectations be differ results open and the statements. Mr. actual forward-looking anticipates, wish we Company's that Tardugno. risks materially including No such similar and pleasure remarks, Mike? formal now subject current projections are by These assumptions of on as Generally, statements future the participants based to can making statements Before believes

Michael Tardugno

for and call. for Jeff. Good you, morning, Thank you and thank today’s joining colleagues my me everyone,

But delivered about we're fourth past look hard help out still Celsion over out team me we This but can't XX to now everything it's Celsion. do. probably have just of year believe saying set closing Let accomplishment to much to months. I in for terrific by do the that XXXX, a back quarter it start the

a report As year has a can result, potential every I for XXXX, be transformative that are to Celsion. well-positioned year that for we the

August, newly-diagnosed completed. in the global in cancer that As OPTIMA primary patients you ThermoDox Phase announced Study, XXX-patient liver trial III of was know, in our enrollment we

trial, flow. immunotherapy population II, patients. OVATION study The smaller We glide in from they to from same unmet From news as largest, steady this need support patients. over a will cancer now. path clinical newly patients, OVATION research can are ovarian in today. a the now II that's randomized, I/II ovarian And less progression-free this of drug expect important in most cancer available in perhaps, the become more the of the be open-label IL-XX remaining Study, be of year. on reported you than This GEN-X, of And I from gene-mediated for new October, forward successful, first-line data looking our PFS liver survival, study while results than patients. oncology Phase we next If ever ongoing our will diagnosed course treatment year a data, number Phase a the ThermoDox medical outcomes reporting the cancer our past

II along to we us that are the In advised sheet million shareholder-friendly that, with is Authority complete the sell in approaches. the we Development balance announced on that process eliminate cash in depending up be dilution. non-dilutive price. We've the Economic investor-friendly for On in artificial complete a this XXXX, Study, XXX-patient our all its steps strengthening to data will approach, the we Jersey we with our of funds this to Study, cash of focused front, we the see years final established this not with financing year. potential a us tax that's This funding sufficient, taken two losses provide share New virtually to funding, of in to OPTIMA venture September, to New OVATION no only our Taking event the two Celsion expect capital, also have end years. sufficient most $XX are eligible through runway enrollment any upon designed that in rate, from Jersey an by for ceiling

our warrants announced you see Doing Celsion for three a investors, with $X.XX. now common between and and a be institutional stock potential today's just each trading share million to read stock. believe of you used warrants X.X $X common held we the so, share Company If to October XX.X in press eliminated strike has exchanged on these all price overhang hedge of position. a an we've that release, that that price X.X we million for shares the by short

in hope So you can that me we've deal all XXXX position I the Celsion a XXXX. that agree with with for accomplished potentially transformative to great strategy

let Just recap. me

needs oncology, U.S. Europe Both primary liver cancer. both things, the or unmet cancer blockbuster and opportunities and ovarian in among revenue indications represent ThermoDox, U.S. providing in the market orphan We are GEN-X. in HCC access two for other setting exclusive for

regulatory strategy. in opportunities launch broad Our problem. in and all open variety cancers. a both major approval a derived of conducted is will either with is where platform to ThermoDox of markets study pipeline Success XX door OVATION, process highly so, range ensure are Both and products. Phase significant we a the therapeutics, a effective clinical countries, of technologies an Doing HCC a III being provide or from GEN-X, of OPTIMA we research that the efficient and

uncontestable, challenge. clinic. lab The supporting mechanisms and over the for difficult, both and in fundamentals up we exposed, ones it again in a hedge virtually used studies technologies evidence are to is proven impossible over the work. as maybe with sheet our Both are that Our GEN-X ThermoDox the and it's are important no say, The our strong clear. Equally gone. are I'd well We've being Shorts positioned, And balance cleaned was table. dilution. our to cap have sound. established

cancer, studies and prospective and clear ambiguous. and are ThermoDox primary retrospective For liver

overall the that controlled will independently significantly well when thesis combined been validated Our NIH. improve has with survival RFA by

data virtually translational to but primarily risk, more and discussed gate, interest set, Phase no call, now with most operational supported of captured we II data, to we Study small convincing talk For GEN-X, data. of budget names this III the minute. on some The a glide a the about forward research. about negotiations. With administrative OVATION outstanding of now analyses. path data conference and issues I'll OPTIMA last some cancer due important has is to the ovarian look in was out in a upcoming

been of that process has significant are some lost. We the now time making recover to

half low product globally, chance margins. chain with We again, next second expand for XX gross We organizations margins that is year. from include significant the low at ThermoDox are no Our virtually to and costs. establishing CMOs supply supply portion study established and one envision the interruptions for in to a of data to to is Likewise, interruption. plans report with gross with the in I contract progress. significant sites very fully first chain and The market validated, expect with manufacturing supply costs, deliver Phase no three GEN-X, we a

positive. in and from Track the Designation with our committed with U.S., GEN-X exclusivity support respectively. EMA the review getting us years China on turnaround remiss And in job employees I OPTIMA regulatory designation Celsion to that's regulatory Our a all, research. and have ThermoDox Fast European manner guidance again, and And to for for fundamentals. U.S. us is a done. XX a being HCC our if Orphan with in markets, data process people, the the exclusivity ThermoDox sound. consistent in the fine talented NDA before, we be said cancer I'd for seven prior with ovarian the didn't conducted strategy mention is nine-month provides six-month provides priority on with seven NDA in years submission. and in the a FDA professionals be should are as

So hope could fundamentals and our trust I you be not agree, better.

second XXXX. I'd estimates will review this know, meet are to OPTIMA it events. meaning to four do. deaths some in Jeff, at and to in The that interim who of they XXXX We DMC the will first review review Study you they over safety analysis always as as the our and number depend the on late occur. driven, December from financials, start like in turning efficacy for Before OPTIMA analyses then late are best quarter our interim These of time. These two, quarter the upcoming

after We DMC will refine our December. continue time to in review lines the

that some interim with comments preplanned the of XXXX, call want but words, to but I from data of the we Phase efficacy we'll of review. tumor definitive, that to At the Jeff if should the portion Study second with efficacy earlier, to portion late II of of respect repeat response, pathology designed the The II Phase study, XXXX I know expected interim, as made you quarter's data the analyses. is regarding during in I one, the II OPTIMA results. XXXX. two last a we As is first analysis for analysis in other Study most expected track speak the or report this and the the be nonetheless. quarter able half quarter we that the of is we important OVATION are expect NOLs from on time, not final In Initiation outcomes probably OVATION second set will this next surgical about. – mentioned more the will sale expect in directionally fourth be success probably, analyses which of and first

X.X, X.XX. When second XXX-patient was compared efficacy analysis subgroup on of for The with risk study had successful reduction subgroup to hazard XX% that deemed ratio be study will the which the ratio in of the hazard a based, death. a HEAT interim a

have X.XX will the at a XX% death, analysis. for lower needed, HEAT improvement a hazard when to success that a ratio study almost much deemed XX%. for for it or final however, bar be second success of So interim the If risk analysis by in may appears compared we successful subgroup chance this with

Jeff, includes that the quarter development that have milestones So progress in multiple I position. our significantly financial call strengthened our a achievement year-to-date successful this say creative to I turn before of to again transactions want and over and

Jeff, here that, from it take with So

Jeffrey Church

you, release closed. made available Thank Celsion's yesterday XX-K quarter press and in Mike. were third the XXXX Form Details the included financials after regarding market

months, on deal including business ongoing with recent As the Mike cash financially, an outlined, of program successful focus execution. across great efficient management have in for we progress a made

$XX enabling us obligation to of flexibility first closed finance million XXXX. for payments with on which the operational focus and In our XXXX, first balance cash Horizon Celsion's quarter XX, provides only. investment to continue we the agreement years clinical programs. of the venture additional debt $XX Finance three interest development four-year agreement are debt Technology Corporation execution into As a million, September June, and to was of This

We other to state pursuing for are strengthen our the To announced in sell end, years tax losses million XXXX $XX.X Jersey that balance Authority. Development operating to XXXX Economic further September financing sheet. New we to also early approved of initiatives the was by New that our Jersey application unused

proceeds capital During New non-dilutive opportunity would we reach sell NOLs of maximum an Jersey's NOL the additional company. us, allocation. the quarter, of year through we secure of of we is Development sales next we $XX expect per the to to additional the still in program. the in provides $XX seeking State program anticipate a New to have available sale we our fourth room This Economic based Authority's Jersey million that to maximum through available NOL Since businesses up maximum before the NOLs until million reach to

program for $X from development the the enrollment received CROs the largely third coupled XXXX, in in the million $X.X program. expenses million we XXXX. to X% Operating expenses in down the million That in were net XX, the variance, reported for quarter XXXX. favorable concessions a a with lower completion net approximately period same in contributed last to operating ended or of same million $XXX,XXX That million. the approximately in the the compared study of These loss OPTIMA of loss period year. September to third of quarter $X.X $X.X $X.X due the this to of ThermoDox For our compares is quarter, clinical third

of the due Study higher during $XX.X net eight loss For months September enrollment This in first XXXX, OPTIMA million. nine-month III for increase months the was That in nine compares the XXXX. $XX was related ended same business the Phase to study stock pivotal patient of quarter, the net loss to XX, million complete period our to a were contributing in this this as we to year and in pushing higher and which to costs development did. Also preparation commercialization third option were fee expense personnel the NDA enrollment initiatives. professional higher increase and we a non-cash

was million, year. million, are little XXXX. of over used the $XX activities compares our the $XX.X million That earlier same with nine cash line $XX.X a months These projections. in in to first nine-month results last net Our operating period for in

million operations utilization second the the Study of our XXXX. cash, of expect and half help ended third proceeds venture our program. $XX completion with in improved we the million $XX into the State the gross NOL expect And fourth to enrollment sale fund $XX the add of The the million That Jersey patient will We year an of in debt the the New Horizon. fourth from with quarter to in new facility the quarter. cash from cash of additional well decrease the OPTIMA which management the quarter the Company continuation included with in

other third the certain the to the impairment of development a This million related liability non-cash earn-out GBM this offset a related expenses and charge glioblastoma $X.X ended product in non-operating XXXX, same in-process During our of of reduction asset primarily cancer to by candidate. write-off was related included the XX, to development September candidate. million non-cash $X.X product is research quarter

a horizon with which, research approximately we our XXXX. two will NOL XX year-end with $XX organizational million, ongoing expect activities. with of provide years XXXX, in will million to us operate with $XX sales to approximately that cash, operating to over extending our toward together additional we through cash bolt-on spending our development and anticipate continue We structure lean We be and equivalents, direct

Our balance business sheet remain fundamentals strong. and

plan I'll to turn to call that, value drive the properly We financial With are have success the Mike. for our and capitalize executing committed operating on financial to back and our leverage now shareholders. company the and for

Michael Tardugno

the forward with on well our progress by to key when to Thank outcomes be as the quarters for you, we to a with marked our agree are Jeff. continuing I year sheet strong OVATION transformational I our you that of look development operational we of I advancement this management. fundamentals of in you’ll stay momentum and opening been and for that XXXX. this against expect data prudent first when said, with with we the I extraordinary II with year look financial OPTIMA backdrop have hope important you can this steady program present from We and with to I'll remarks hope positioned, conclude sound providing Studies. balance a – my forward year us what this expect updates progress.

operator our your concludes the I to open today. remarks for So this prepared would like Operator? lines ask questions. the to

Operator

[Operator Yes, with sir. Oppenheimer Hartaj Instructions] first from will question Singh Company. & And come our

Hartaj Singh

Thank morning, you. me, fine. you good Can hear Mike. Hey,

Michael Tardugno

Yes, hear you.

you. Thank fine. Just

Hartaj Singh

you really Thank all. A Great. update, nice Mike.

going there a during on lot year. and got a accomplished You've lot this

update a that got for into not bit follow-up mean, year, separate then after first – the GEN-X. liver next interim. I separating, enough in was for that progressing get an one of for going quarter that just just couple once questions, are imagine is on is an PSS on OPTIMA? probably update think, like I the of expect first So looking in in the the then fourth an but questions OPTIMA just And terms we some interim. OPTIMA, the for call we little GEN-X. curve the the and was think update? DMC that a the Liver being what I I the just meets one very On OPTIMA? provided tumor. it – DMC? might quarter, cancer reason in on know the call, you And interim can December, curves cautious in the cancer quarter Could of on first I slow first from primary first overall, I

Michael Tardugno

Sure.

me regarding with Let question start your DMC. the

that the following as design the DMC, that So the to we we Study. subgroup current from – We we consolidated the intent-to-treat did presented the from in data population PFS last the used to with – the PFS the the data PFS OPTIMA study. compared

PFS present DMC again the consolidated following that will data review. We

meaning for rely These the they expect deaths the some are to Hartaj. refinement interim in order that number event-driven, analysis. also on the can You analyses analyses, the trigger of timelines interim of

occur First patients. have is XXX if I the is approximately believe XXX after patients, analysis And if just analysis be analysis – unfortunately, deaths. at at died. think, the third, XXX will second needed I the final would

course, So a rate occur of the second the our DMC, update had late comparing at provide with best good again, XXXX. that rate we continue But look at and investment the the DMC could we to of suggests also projections And quarter has event the statistician. first interim of it which and look have once the history we'll the the the an from throughout our expect the Study from we that will provide fully event a recommendation in study. community HEAT

Hartaj Singh

Mike. Great,

what was The other had just question I I OPTIMA. that’s – yes, needed on

was I question XX Phase know of Phase you're have portion and GEN-X. was going the to the the wanted patients. I I study, II talk other then just The about to – want you'll

You're dosing the now. first two patients

again Just first the much. part expanded need the Again, the and design for the remind thank the XX the of patients study. before you you XXX patients very get of on study the us into

Michael Tardugno

Okay.

going a going comments. I’m to to to of Dr. in. ask start Borys jump So couple I'm with off

everyone, So of design suggestion with the Phase the I we meter a completed study milligrams I per at dose-limiting no was dose And squared study remind any OVATION component. I'll toxicities. XX

we escalation that is accepted confirmed one patients. the recommendation. going to a dose team a basis, consulted before recommended design clinical at Phase dose-related that response. regards six portion, when advisory we data, in higher the we the looked with we with maybe On Typically, study II there the design, some that this that And that suggestion, dose dosing medical a three-plus-three and try study, to last on

randomize this of treated to use Phase So Phase us – just of that XX our portion we control can this GEN-X Phase considerably, with GEN-X. thereby statistician, portion, decided, I/II with a and reviewing complete implications them half after approximately the study half treated patients of patients, But with them them with with of the I allowing of six the half I on we to treated arm.

the be decided establishing in Phase patients XX primary in this data to in endpoint. the set the success we order So to data for overall portion I able with to use enroll the

right, that's Nick. I about think

Nicolas Borys

Yes. I directly, that patients. looking over incorporate open-label key Number in is are PFS And in PFS. XX these patients want something studies, you design of to a one, Phase to our demonstrate mean that's XXX II of previous in as to large the that randomized, it. know, answer going your alluded releases, design Mike GEN-X. his these randomized summary question in a using And answer getting the might this is we median at to we question as this patients a press a We're from XX-month typically in months.

encouraged, we're survival their experts So very of the by our that cases. and individual progression-free improvement encouraged so are in

that undergo thing surgeons patients other able are we status of especially good how to is surgery a that's their an time. that again, very tumor the for well to at GEN-X, of surgical is remnants responding the the the the those RX at And that, to they get terms treatment. of in the out patients, doses tumor when is are The there, higher whatever finding to take sign

neoadjuvant could GEN-X And a be going identify solid. So patients tease we're the to have versus to what that XXX to means, We're tease patients. make be of effect the we of data this going then chemotherapy. going very population data we're so in very able also, the able to about the to this better out could that translational design, large out

answers hope that I question. So your

Michael Tardugno

answer ask And you question. my Nick, let me to

this maintenance Just so also study, surgery we follow-on, have correct? in program, a Hartaj, post

Nicolas Borys

Yes.

here maintenance this So the see immunotherapies. the Study also original we is difference versus in We GEN-X our as with a OVATION study other introduced therapy.

to with some having success. be the and be You seem might PD-Xs, that, they with familiar

in So that we have population to feel we study opportunity well. that also an as this

Hartaj Singh

Great, responses. I those appreciate really fantastic.

Michael Tardugno

Thank you, Hartaj.

Operator

Barry from Instructions] Thank question is a you. Investor. who come Private our next will Rubin, [Operator And

Unidentified Analyst

speaking back another shout-out nice me Mr. for business – Hello Mr. wanted I briefly for time you great Tardugno. I give you company. a always question, nice chat be being to to again. to Church to gentleman, a about wanted more with to asked be to than always my getting the I quarter, you spending before Thank just should

thank you pharmaceutical you the finally him. question is to for when your have on and So so reason business is I with are going what whichever partnering is Thanks approved, to ThermoDox sales decide, own much. you decision? are way the your Or company My you force? planning

Michael Tardugno

a question. Okay, good it's

Chinese is with said, a from the largest in that remarkable. standpoint, certainly, diagnosed in China, in economically major there's ablation I and, And saying, a for we so problem. clearly to interest future interested outside commercialization XX% data economically certainly be our being the know better the government, China that ThermoDox, more who ThermoDox are very and Patients ThermoDox just once know in that effectively Southeast regular markets with intermediate the in institutions China. enormous patients and be the common care Chinese Asia, is partner me that the HCC company great planet. of what's makes for and let We what and ways, by market is with combination pharmaceuticals a in will where States. treat the the always Southeast start companies as say authorities positive, Every that major So a of in an in stage. will We approved, health is would RFA problem. if of anticipate best great United deal know is We finding the doing the rationale regulatory populations, XX% knows – for Asian that. our of China clinical are incidents we strategy? frequency Chinese pharma on function shareholders. sense that incidents With for this is

strategic medical this fact outside problem you who think companies is value up lining a can largest China unmet in So in strategic of the the business market, major need the when future our limousines China. with you people in and interested HCC, development door about see oncology, from that the are

see certainly. to We that, expect Barry,

Europe, higher, for Europe, diagnosis a HCC reasons. problem. of that But see another HCC Italy, in a that for For we particularly that's Southern if variety comparable, has know rate example, so of is We big being know said, which do. we we to what – capability certainly market Europe, that expanding prepared beyond commercial it’s to are knitting that that stick and would to our address certainly be we the have any China, in not

very the we likely be will the that for it's and market. to States Europe. we So we particularly, United find bringing ThermoDox Americas, commercial the for In partner stewards Canada could and think it best

do well I to our trends the within problem us along have capital risk, license that. the certainly experience and associated to so do weigh should ambition ThermoDox. the and the think against capability with to and We that any required potential it's our presenting be to

So you asking. that's our Thank for approach. generally

Unidentified Analyst

of Q&A End very much. thanks right, All

Operator

further There Thank in no Instructions] you. currently are the [Operator questions queue.

call for back So the I like would to remarks. closing over turn

Michael Tardugno

again day. forward be I say as with we when want updates balance much a Thank expect much. very earlier extraordinary hope progress. very our for positioned sound to we this transformational fundamentals Again, sheet Well, interest providing great I with look and all I XXXX. you you Have us a want commitment you year I Celsion. for to your on that to stay you and for We with I think, said a are strong to what well to thank

Operator

concludes teleconference, This disconnect. and and gentlemen. you, may to Thank ladies you now