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Celsion (CLSN)

Participants
Jeffrey Church Senior Vice President and Chief Financial Officer
Michael Tardugno Chairman, President and Chief Executive Officer
Nicholas Borys Chief Medical Officer
Emma Nealon Oppenheimer
Edward Sherman DSW Associates
Call transcript
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Operator

Good morning. My name is Matt and I will be your conference operator today. At this time, I would like to welcome you to the Celsion’s First Quarter 2018 Financial Results Conference Call. [Operator Instructions] This call is being recorded. At this time, I would like to turn the call over to Mr. Vice Chief Senior Officer. Celsion’s Church, President Financial and Jeffrey Please proceed, Mr. Church.

Jeffrey Church

results, morning, Good to to quarter this everyone our market you. before discuss we the morning first first call welcome conference and Thank opened. announced investor quarter our which XXXX

call summarize President will and today, Today’s remain will for available available first and our provide financial Tardugno call CEO, programs clinical XX Chairman, on archived quarter. update beginning results XX, operational May replay and our on for Celsion’s and our as Michael will by During an I be will will available XXXX be a website days. well until phone tomorrow as the Celsion’s

regarding are to obligation we the many now Michael the Before over such turn projections the statements forward-looking assumptions participants for statements. Mr. reports based date wish the based call of differ and are may Tardugno. The update as forth formal and and in guaranteed we is conference forward-looking can with upon company’s expectations of Celsion’s such forward-looking only about the be Celsion call, otherwise future any of expression. on predict. required to as inform open except of this difficult events. new to this Mike? no by statements and including call materially should, which can events information remarks, At future set may, undertakes would end call the from to actual statements to results like similar uncertainties, or SEC, the number These and and I terminology provided call current on we law. today’s filed questions. a made by this we be call to on terms identified Generally, information, will those expectations will begin current subject of periodic anticipate are that expect, statements as forward-looking No and risks be making

Michael Tardugno

call. Officer everyone Thank Officer have from are you, morning, Financial Jeff. Nicholas Dr. Good and today’s Celsion’s Medical our and you Borys, Jeffrey Chief Church, whom you for With heard. just me joining thank Chief

As we update on opportunity and to you questions. progress our have to your to pleased the answer are always, very

Now, call reminding Annual Shareholder meeting joining shareholders will of that consider the I let week our the Tuesday us you Westin for me encourage held to start New would Hotel of can. Princeton, this by to on in XXXX at Meeting you be like next Jersey, record if all

person always, brief closes, few our month a with held pleasure call great see have it’s we Since deal. meet a little much you but relatively call end you, a redundant perhaps and year repeating. you to a in will to and as ago, be is are just because there If we in whenever on great conference over today’s possible worth

study, with today that’s first when promising timely liver start X of to Number study points me very of our trial sufficient call, analysis XXXX. of a pivotal our let have unmet of XX full the objectives, by a March and of ensures the important focus the ThermoDox, this and of rate entered oncology newly gene both top treatment a control and operationally OPTIMA cancer an events our investors development immunotherapy arm advanced of balance I the cash GEN-X And we very up year. where for ended the X/X X will trial ovarian need patients. in in OPTIMA Phase including cancer to runway end OVATION of as data diagnosed XX to strong in conserves enrollment this diagnosed over our to clinical mediated Phase medical months trials, in line reminds two the the year from in with remaining Celsion we importantly of study, primary first in number the two, started be year you largest II number four key remind Celsion a the cash and newly the and more the one, achieve the So, patients the consider worth you, and tight of sheet the cohort made call that II initiation results OVATION study in from in arm interim X the and

if should our to XXXX, the point us. over financial at worth behind of into flow three add operating NOLs, XXXX. are Celsion be be pursuing add sale news have thinking operating of which to or about our means before should from And OPTIMA to expectation including non-dilutive key our into the Investors net third The in X consider, losses course two of well point developments we now the taking to of to advance. steady the you could is trials resources, the and company study continue XXXX run-rate quarters well Phase results which will

in will speak call. later to this in more the Now, detail Jeff

are very full That’s timely providing focus efficient to points, strategy commitment of interim inflation balance shareholder Phase that development a with and strong enrollment ensuring key cash critical utilization, financing pleased first of We X on runway client. clinical study developments of the and goals including steady a efficacy sheet tight analysis, XXXX to our achievement value. a focuses flow and in news operationally the

heat in radiofrequency implies our beginning patient like to drug, a formulation study. know, is with greater in X the liposomal XX X studies a a the investigation with lead review study minimum in Now, on ThermoDox. tumors X I than centimeters, minutes for would a doxorubicin, called the less you centimeters clinical of than our ThermoDox, administered ablation, population Phase being as sensitive with combination in technology OPTIMA evaluated of as name

impact patient a we carcinoma, product. is XXX The of never RFA of years. primary study to reached followed liver for and X.X the in XX% this HEAT quality years in on combined of on XX control hepatocellular XX group. for the cancer ThermoDox. minutes Median and countries for type to being zones X A treat correctly for is minimum time across represents to protocol population time of over just markets up XXX-patient global when is years RFA was as centimeter overall the a XX X Now, application than the prior and our that our that or based survival. with to that’s survival the after intent more the arm trial in better survival months, treatment X.X it improvement of group is call from was median XX% greater The HCC the significant conducted lesions study, XX than in a subgroup is all death thesis will over understanding

cured. Our the investigators administered be excited potential properly to with RFA about are results of dose that the has ThermoDox that concluded the single

We have been this conferences multiple over of presenting number medical narrative the last at years.

In for combining addition standardized in of thesis minimum been our with a survival to models. tested has XX ThermoDox observations, preclinical the minutes for computational RFA and

to Our of XXXX in in greater and including alone. in Journal Data each reviewed DMC plus in survival. includes our other review for The RFA first and from longer X study in cover multiple Monitoring doxorubicin unanimously potential than its minimum was basis Committee is or the of things, April, sites by on community These compliance tumor supporting assessment year administered journals, bidding medical concentration, conclusion every integrity validated the X with reviewed study recommended was met has publications schedule that in significant that according peer was the has continued In safety unblended for Independent OPTIMA the the cancer effective overall with this Celsion’s the It the among for and in trial greater lesion specified treatment potential the for our the research April, in past based RFA of research February. the study the the XXXX rehypothesize the premise to analyses target their the the of published of been XX% early support XXXX. to protocol more not ensuring data clinical OPTIMA of survival journals. and benefit the Hyperthermia and randomized virtually properly surrounding that DMC and patients been have respect time. Recommendation combining readout. tissue through data Manuscripts improvement its data ThermoDox the HEAT analysis heating of heated,

to blinded in PSS no the that found be importantly, in acceptance so with far continue point is in remains and in In want this this emphasize consistent study subgroup in population ThermoDox’s that intent the progression-free treating that very the showed performance ThermoDox RFA will be can we encouraging the believe far We benefit intent blinded at that in and study study learned the HEAT the I and again. the view benefit study. to can PFS is with blind We finding as properly nevertheless HEAT with so specifically. we that survival subgroup treat in definitive and in population administered consistent to to the addition drawn population to in conclusion was the OPTIMA survival the blinded population progression-free treat and HCC. that the study patient learned for the showed the see

of for of median conducted lesion population want overall In analysis months. new repeat XXX death I in XXXX, the the to X we terabytes arm different in some are which population in call last an of now an to HEAT independent of treat from those Director single data just months, provided with intent than comments that’s from HEAT to than at greater Celsion. Institutes to Interventional saw of National the XX treatment XX study Oncology, we the of equal the where last the discussed I request March patients improvement from greater Now, and a call, survival study, to time who then Health they

evaluated. patients lesion patients the lesions were So this population, with in study single all single

of RFA study Korea. world. improvement RFA Seoul, RSNA Conference, study This selection at XXXX, North and X with the in annually selected two in it’s Society is of Phase study Tak X in was the part the HEAT evaluating of conducted Association’s ThermoDox Annual Young of abstract manuscript leading Presidential Won in luxury Scientific the Meeting in in author Korean times February combination too that of not conference that’s in the by true South X conferences with RFA significant RFA identical HEAT identical Radiological combined XXth concluded the looked Dr. the by While of largest an was virtually company’s were the study, More for of and alone. discussing America presentation when cohorts, evaluation Cancer RFA NIH Liver medical These heating resulted one is the of statistically longer December the presented overall alone, recently ThermoDox a virtually findings survival. XXXX, with ThermoDox, of with

data of the So when overall investigators NIH’s look HEAT the Tak’s colleagues the medical survival interest the improvement results study at you multiple presentation. are Dr. study in this, showing in their at HEAT in and an to bringing all conferences, on interest

all also you OPTIMA that Street XX approved study this globe does. reviewed authorities all America and said can’t of help the medical If will clearly Europe, the regulatory conclude where in one I note it including time, markets, Asia the major from look at the this, is I that North protocol. Wall HCC across but community before, gets rare as you before and

strategy interactions. Our on based these is regulatory

support revenue other patients been market for provides designation in drug received and of X to and and We for granted Canada, respectively Philippines, both market United to designation number for cancer designed and Taiwan, Europe, the orphan fast-track ThermoDox sufficient OPTIMA in have primary XX South these the things from Korea, each U.S., also filings China, launch which U.S., Vietnam. major in extends country the priority Malaysia States Thailand, study years ThermoDox has In the registration has among Europe, liver exclusivity review. enroll markets. and

as many can trial, a Additionally, in that’s the for direct ongoing is Borys OPTIMA trial Administration the without Phase China the the the informed need me, applications. filing as study the CFDA, and the basis file Dr. foreign X could basis regulatory data prior approval or so China required to from if serve company which U.S. Celsion, successful, that’s Europe, for is Drug a Food in serve for and currently

originating XXX,XXX launch in financial this its departure in Celsion provide China would most globally than patients and and HCC of originally conduction course but While earlier accelerate ThermoDox China approved, is perhaps significant significantly with filing regulatory diagnosed from the market China represents each XX% deal if to newly opportunity China approximately allow for of for in anticipated. year.

Practice, on have and regard high class to protocol research internationally management Good the Clinical contract execution quality world to compliance, we recognized with the ensure trial teams analytics. data data organizations Now, itself and side, engaged adherence ICH

redundant a highly market. have in supporting organizations and gross high the and chain reliable all supply We world of also contract of registered proven producing margins regions of capable with manufacturing were ThermoDox X the regardless

Now, GEN-X. I want to turn to

and last plasmid technology system gene-mediated I developed system is which fight cytokine, nanoparticle As is nanoparticles these discussed even plasmid cells for or synthetic the production to body cavity agent immune each cell on biopharmacy cavity locally immunotherapy, malignancy. a of over created into administered IL-XX, metabolic a GEN-X TheraPlas into proprietary month, the turning the body’s platform When into our a a peritoneum interleukin-XX. or local the transvect a TheraPlas. surgical incorporated is potent the interleukin-XX. sustained removal GEN-X’s coded for take surrounding of called machinery, the our mass, like The IL-XX anticancer or tumor the by invade recruits or a DNA active little delivery bladder

we studying GEN-X is first cancer. know is are ovarian The as for you indication

this diagnosed surviving less there XX% years. with than For chance is cancer, patients of a X newly

for signs major The weekly recurrent debulking of cancer X have newly goal I is spread ovarian is is the by ovarian in to stages previous GEN-X advanced GEN-X clinical both of chemotherapy our mass study. when monotherapy GEN-X regimen been added results. study in disease, OVATION plus the is The reasons a then the cancer neoadjuvant study, clear diagnosis clinical chemotherapy in this One surgery. shrinking up drying surgical disease Xb cycles in in newly with evaluated patients Phase throughout made particularly importantly, combination as is of populations the the outcome we I tumor activity trials promising surgery In has patients patient interval benefit fluids escalation GEN-X X, the cancer in the of the that this dosing however, standard chemotherapy X the followed region. used OVATION chemotherapy pelvic demonstrated In neoadjuvant and when Most to diagnosed trial, in accompanying improve and with and showing [indiscernible]. and by followed patients. diagnosed by of advanced

include I very findings. would findings say following this Our the from this in study include and impressive population

PFS up significant dose with highest oversight clear milligrams and the any GEN-X. find toxicities neoadjuvant dose. among the findings clinical toxicities XXX% XX environment First, meter tumor able to dose an limiting or investigators patients. tested in in PFS importantly patient remove patients the and chemotherapy in of the bioactivity GEN-X with in associated XX% are XX% The changes all were partial appear the in treated response this over be is plus following as to The a XX outcome visible is demonstrated is per Historically, at tumor included highest patients, resection committee, surgeons efficacy XX no safe this square. to RX months. approximately and in complete completely is months. known dose-dependent The to micro the did prone PFS the of Distinct immune projected be that’s population findings patients clinical of treated in immunological not result. There protocol. DSMB,

cohort X/X treatment It’s Phase called XXXX, to II Now, a of treat clinical November study. the plan of randomized per submission was We last dose the was highest GEN-X approximately an OVATION last arm we dose based the open the by these that’s X the study. on in the – announced findings with dose the patients previous square, XXX FDA to in that that first the greater label for localized cancer. treated the treated, milligrams protocol XX% meter trial study at ovarian the last than XX% in

criteria patients. XXX with the with start square, dose the per to X continuation will are the up portion study The followed the of as addition. XXX selected prior by major I in entry So, protocol one the milligrams OVATION in same meter treatment Phase study and a

of debulking will additional a to Following this up continue receive maintenance doses surgery, be will intraperitoneal GEN-X, X to patients therapy.

a is effect hypothesis surgery beneficial stimulation immune of that progression. the delaying Our system further provide by may after continuous

enrollment the XXXX. portion initiating Before a this portion open in away X in to This the first we weeks we X, X by and anticipate Phase expect study to the an XXXX. of data Phase throughout June Phase few initiate periodically be just of label study quarter report will expect

GEN-X’s are PIs. as our we the potential Now, excited with

highlighted in in form – associated of designed New March presentation investor to IL-XX Premal Treatments GEN-X entitled Dr. an Horizons and with protein novel and the event presentation the Thaker, for York. presented deploy Ovarian approach without Thaker’s our program example, lead As a at toxicities development from OVATION the the an outline Cancer: GEN-X principal made XXXX, New is study. a the Dr. results recombinant investigator

consistent Our changes systemic levels no cytokines and little and IL-XX GEN-X the systemic its in immunological anticancer of peritoneal toxicities. circulation with with increase changes ability presentation noted downstream of to

If you are on be our found interested, presentation can website.

Now, before say our I not like XXXX expect to be an I CFO, important, call year. to transformational to turning would the over that if

efforts backed way, with said our excellence operational progress call, I focused our ThermoDox make for last development capital management. on is by Gen-X think and in financial year. responsible achieved I One will significant this our and

to that financials, to will discuss with Now, Jeff. now turn Jeff? the our I call over

Jeffrey Church

Thank you, Mike.

very XXXX, total the candidates. cash of the execute on product $XX.X During development we continued ended focus million investments. a our lead and quarter important two tight clinical of to first We with our initiatives with quarter

highest projections, of quarter During million the insurance in us projections. our payments bonuses. as our with in operating of budget things with the XXXX approximately Based $X.X enables Typically, we to one-time line on each year needs first year cover our into to cash cash first used due quarter annual position respect quarter, for current premiums the is the third respective projected our XXXX. performance to current

additional innovative in Forbes net into their were capital XXXX New release XXXX important Jersey. the of program which the This We losses additional opportunity clinical like and to GEN-X several doing creative development this economic is extend morning. run-rate by million to Celsion, the development program first that points cash generate pursuing are in half operating non-dilutive generating this accumulated inflection market $XX well included quarter offered companies of We could program Celsion’s state of the businesses. estimate press sell programs. value to first for issued was both opened ThermoDox the before beyond financials profit

for quarter ended was Our filed Form XX-Q XX also morning. the March this

QX We continue trial to the our shareholder tight for X create in cancer to focus expenses a primary in ovarian cash liver during efficient to diagnosed clinical projections our for in of in to most $X.X period value. management. of our million maintain and Phase in were X/X newly follow-on This and cancer decrease ensure year. result reduction XXXX our cash last patients. cost compared efforts million XXXX the earlier monitor Operating the is pivotal prudent We the ThermoDox cash expenditures Phase $X.X use very GEN-X with implemented same on and trial line

on This of study consistent XXXX. Our in patient projected year XXXX quarter the this year $X averaging XXX or for development approximately into we year focus about remain of in through this GEN-X the and million per Phase the OPTIMA is third half increase second quarter. XXXX our enrollment entire $XX clinical cash X of utilization full as projection complete should million

spending operate directed to of is continue activities. equivalent with development and We lean approximately full-time employees. research Most XX to our a structure organizational with

is maintaining sheet to we continue around we we As important our forward, momentum program. look strong that lead have strong built the balance believe development the

which ended to loss to XXXX, million of compared a a in the R&D March costs compares quarter for prior $X.X were reported $X.X we of For net net year loss same million period. XXXX million million QX in $X.X XX, XXXX. $X.X the

OPTIMA lower initiatives. the value programs shareholder those were administrative first to focus to through XXXX. G&A pivotal and drive business tighter non-cash quarter costs due expenditures largely X to services the higher and our to coupled of development on with the readout help development Phase General million professional development million for in and near-term due fees were increase $X.X clinical study. related XXXX and that research in higher believe for of to compensation expenses in recruiting we were $X.X commercialization Our compared This stock expense, consulting

paying debt that first $XXX,XXX June the of balance our in fundamentals result with venture interest of by interest sheet a of loan in XXXX to had like our business last expense to conclude no As XXXX. would Hercules are and in I the year. expense compares strong. quarter all company stating That of

development each We around to programs. positioned milestones are well our of deliver product important

capitalize We back have will now to support and success. the Mike. the future properly tools to the for call financial company turn I

Michael Tardugno

Jeff. remarks the transform I not two conclude research as shows GEN-X and ThermoDox change but to our practice, continued the pro-prognosis. potential exciting trajectory represent you, with and positive opportunity in saying Thank only will the If to drug cancer have patient’s either company advances candidates that by lives or well. data medical prepared my we have the for patients

Our very is important. work

I cancers. aspirations pursuit with high our are progress to of patients this year Our we medicines forward reporting for continue new as difficult our effective look and

the for line like to the questions. to open So operator Operator? I your ask now, would

Operator

our Singh Oppenheimer. with Instructions] question And first [Operator you. from Thank will Hartaj come

Emma Nealon

for Hi, Emma This Hartaj. on good actually morning. is

any on First, it update OPTIMA, the quarter? last is about was enrollment I think status XX% there for

Michael Tardugno

Yes.

enrolled. So, when XX% are we continue over to we schedules, to XX%, progress our according

both little of a projections actually our bit out. So, in

Emma Nealon

Great. from the And plan Phase medical OVATION to Xb GEN-X do data at just conference? on then you present PFS

Michael Tardugno

Nick?

Nicholas Borys

Yes.

up as going a at that are data also it. to writing submitting abstract we conference one We an and with at be that discussing are looking investigators both which our that and presenting

Emma Nealon

come still TBD? kind Great. that of or the a to form announcement initial expect release Should of press in we is

Michael Tardugno

repeat that please, you Could Emma?

Emma Nealon

is come that to PFS determined? should expect that to data around as midyear, is available first a press top When still release the be Sure. or we line

Michael Tardugno

line top Well, press release. would be that a

Emma Nealon

Thank Great. both. you,

Michael Tardugno

you. Thank

Operator

to go Edward Sherman will now with Associates. We Instructions] DSW [Operator

Edward Sherman

guys. Hi

trials, payment GEN-X are that have, two I given you would to when a resources due? milestone a fantastic the you think easy it’s not have conduct doing the be question job for regarding but I that

Michael Tardugno

Yes.

some referred cancer. progress the our as That’s So, happen tied X not GEN-X in of to Phase study until is current on estimate. rights, to XXXX. contingent likely talking are payment to later the that That’s payment milestone the to portion likely value ovarian achieving in they milestone with likely happen not in about

Edward Sherman

Great. And me seek this, let you ask that… you

Michael Tardugno

so just thereof. be Edward milestone at topic, the running or on either election cash while in can paid company’s the combination stock from a

Edward Sherman

Sure, right. I that saw actually.

say but in So, you the and making medical mean the do occasions out? you Why that gets say this the is one be rare the it’s and community getting I is it that the efforts word to investment it the about before where of company critical, is community. what don’t if does think true

Michael Tardugno

Yes.

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we relied hypotheses not and only models out prepared a that also the pursue notably the in we model. in data as from when models, prospective in on these computational in remarks, I but So, and preclinical my study pig pointed evaluated

originally be am extreme trying was time honest company’s radiofrequency not was failed the anyone an what that’s on inappropriate that obvious of the study around reasonable of notion this of was amount subgroup in the HEAT you. took to I study, confidence of study conducted following with to to with All to the that and an ablation any is In a when variability there that – analysis. was get But kind conceived. is a amount skepticism meantime,

NIH. with that inputs incredible company with community an job think radiofrequency incredible I done appropriate ablation by investigation recently an an for has potential job to has the determining analysis analysis of of scientific that successful ThermoDox done on the the independent be the the through research most standardized supporting medical and community and

on narrative the that of getting of a credit, company the subgroup major getting it’s why lot that’s prospective trials, read our are Phase in it, a but the combination analysis it deal and why of it’s community a publication publication so focuses your valid probably on to published, medical analysis. get further putting the great does radiofrequency milestone I and important with for the X ThermoDox point, evaluate that you together computational and if the the a not ablation trial of the all of we preclinical think Now, study, now HEAT publication in to in of

earned we as get the have the research said information present to the after it. medical have that the believe this community time, I Now, right community and I

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Edward Sherman

question, last no HEAT one there off was study that just after more fell uptake to minutes? there Forstein XX intimated that believe Adam reason believe of that the about ask by effective basically may after chart something is I showed If Okay. so XX after minutes, mat, the be would the it ThermoDox a that I

Michael Tardugno

familiar Well, research refer livers function a our [indiscernible] pigs. our manuscript of also that. doxorubicin, in a quite would to And healthy suggest of demonstrating bit CCR I study not the I time otherwise. and the to think there in you would am I publication is publication dwell HEAT on accumulation of with heating

I think just be that dismissed. you would made immediately point that

Edward Sherman

I that but prior the glad hear liposome, sort thought about were that am to it though, why you if obvious? isn’t that HEAT-sensitive if hear am something HEAT glad to of it’s the study why I to actually. case a seemed that if given there that,

Michael Tardugno

Yes.

offline, reasonably that in the tumors it ablation negotiation application the of standard opinion academic not in So, of was with in we the prosecution time out throughout this to turned of take well, our SPA to ablation with of on of should centimeters. group patients some radiofrequency point was was care the administered than And medical X use newly be. this the according There It a procedures the maybe greater was the considerable variability of it radiofrequency diagnosed and in of we practice. fact, consistent radiofrequency not discussion amount spent FTA, during not ablation of have the obvious. the but was of among – a investigators

RFA oversight So, knowledge company’s it a our major wasn’t what twice and there was the of on being of I – lack part oversight communities how point think medical discussion, knowledge the was applied. of was the major a

data, at there back in now your an this HEAT company, study think you embarrassment company, our we stock. if when I have because know, investment look Edward, fact, we some In maybe

Edward Sherman

And I do.

Michael Tardugno

the any Now knows than just more study. radiofrequency when the primary about and not was liver use true the ablation initiated in company that of planet we cancer HEAT other on

Edward Sherman

guys want work. just up job. good a I Keep doing the to you it Okay. are say great

Michael Tardugno

you. Thank

Operator

[Operator Instructions]

Michael Tardugno

more So there operator, questions. appears no be to

those that you ask reading Edward’s accept company. chance with of you your a like to not particularly to may am be So, thank please your and with information call, feel attention to the of and to you conference free for We to meeting next correct knowing time questions, the for questions that your actually and get I for we by going speak on some close the maybe company. you in line, regards interest listening, are those all encourage the the and

that with So you. We very our again, to thank excited for prospects I XXXX. want remain about

count team results. management to this to updated look our we pipeline you and advance again. forward development successful on as You we Thank keep you can

Operator

this And call once for Thank for you does our conclude participation. your today. again,

disconnect. may You now