Celsion (CLSN)

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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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

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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.

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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,

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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

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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

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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.

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Now, GEN-X. I want to turn to

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

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

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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

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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


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


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


Nicholas Borys


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


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


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


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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

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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


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 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


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

disconnect. may You now