Celsion (CLSN)

Jeffrey Church SVP and CFO
Michael Tardugno Chairman, President and CEO
Nicholas Borys Chief Medical Officer
Keith Markey Griffin Securities
Barry Rubin Arsenal Investments
Call transcript
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Good morning. My name is [indiscernible] and I will be your conference operator today. At this time, I would like to welcome you all to the Celsion Third Quarter 2017 Earnings 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. time, Mr. like this call turn At to over Instructions] I to would the [Operator Celsion’s Vice Church, Jeffrey Senior Financial Officer. President and Chief proceed, Please Mr. Church.

Jeffrey Church

quarter the market morning, to which Thank And opened. announced XXXX third we before Good call, investor morning you. this conference everyone. our welcome

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

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

Michael Tardugno

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

we always, to to are update on question. opportunity to delighted progress you answer As and the have our your

the For with story, candidates company pitch. of product give knew I’d a to both trials. have technologies those two you you of quick oncology like are which focus development platform Celsion’s elevated clinical and stage

sensitive of to administered heat incorporates local in target's about IV been the Celsius. solutions. temperature, it’s it’s create releases high nanoparticle at degrees of just locally heated a its the one payload above novel drug are concentration that liposome technologies and body non-chemotherapeutics, XX lead Celsion and presence Our regional tissue The that’s to

oncology and on cellular has interactive Our RFA programmed. liver primary therapeutic of ThermoDox proteins Phase its doxorubicin. this evaluated name based as for local liposomal with agents remaining plasmids, ThermoDox, product being that’s cancer. and DNA equally We call important sequences, name that’s implies, anti-cancer sensitive a TheraPlas for this biologic of which pivotal first transfection platform ablation, medical platform production is is our in the formulation is short for as an the of cell X carcinoma TheraPlas. need as the ThermoDox known second unmet with radiofrequency sustained candidate the combination multi-center largest HCC technology heat study known return for implies global properties, also ability in nanoparticle hepatocellular to as is the

the actively body's the GEN-X. cytokine production protein actually highly interleukin IL-XX to well an is system has is that call been are work very the GEN-X candidate immunotherapy is of cancer immune data, we XX. entirety effected to and ovarian known I/II first Our study platform against the And newly deadly and on patient of in Phase cancers. of GEN-X this we inflammatory with forward announced Phase population. as this III study now evaluated moving Phase a IV encouraging I on patients. we highly diagnosed randomized Phase yesterday in recently evening, recruit based

both grail in largest future there’s potential malignancy product, efficacy two XXX,XXX and unmet medicine So, to lives that's two showing at one both holy the in investigational legacy annually. effects women and of summary folks. And representing remarkable to Phase that of drug II medical platform very one with second in in innovative medicine, in candidates, of one means immunotherapy, and chemotherapy, promise, cancer, the rapidly, the Phase the non-moving safety of the evaluated technologies, improve this and III the some an oncology need over They oncology. ovarian showing

call that Celsion two I drive we one of to some generation. in Our are and both clinic momentum cancers in we if continue been in goals has Gen-X made completed are important of and medicines to if these not that wanted as challenges, have several the successful, conference of remain the past to successfully solutions the announced outside difficult August we’ve right, novel elegant conference the development the on a and most communicated calls touch The and unchanged innovated important pharmaceutical those. milestones over development even the of

the First side. financial on

strong. is sheet balance Our

announced $XX four most us. the to equity significantly We past fashions non-diluted cash we several some our then balance. improved million, months of the totaling available For initiatives did capital we've almost

achieve long the of Our runway the has operating That company cash XXXX. quarter now provides second capital means the position going an follow. to sufficient to

cash subjects of enrollment Phase of ThermoDox full study and spoke appearing study on and projected pivotal first just this the we to expect in we cancer, in quarter of results the in XXXX. the primary we the turn analysis also runway liver is provide pre-point within importantly around study, that X upcoming here, efficacy first XXX to and First, from

X this newly quarter, first [indiscernible] the therapy ovarian GEN-X of will a Additionally, of I/II clinical this for and we patients initiate quarter line as treatment follow-on Phase cancer X fourth year. stage a of study diagnosed

cash Our of And periodic balance. the target of XX conduct throughout the approximately an is the will label our reporting file the enroll be trial results. end clinical and within this safety by also to year study of current XXXX. XX% we’re subjects and open Again,

to just day, we city, our to analysts is Second R&D I remind though our investors I want R&D with of you, that over an to topic the an you which want want XX, update remind today to focused. in clinical that we and I day at go October quickly, programs goal on is provide your have

discussion believe the assess to our potential. long as to go find I invaluable you term you you If website, Celsion’s be from insights the

clinical HCC to the including completed in was immuno-oncology review and disciplines of and our the important With OPTIMA ThermoDox provided Park clinical a and problem study. study briefly case including And study of and importantly of OPTIMA Institute take study the Roswell desk. investigators. financial investigator a interventional presentation supporting surgery regards for from innovation I Xb Europe, three these from moderated GEN-X representing some Investors on discussion you time the audio recently from to Korea, copy the the radiology presenters data the So The Cancer South including clinical Philippines regions health HCC and a experts the discussed. Phase experiences the current and representative regions where leading multiple our Dr. travel hepatology, and on encourage significant are the focused is medical discuss for treatment with study to then lead data translational to the and panel website past all and Borys News listen this from study. hypothesis material. under and among

I important you think long-term intriguing I products. these it and will earlier potential said very insightful consider associates you of instructive, two and find very as as

topic the ThermoDox Study. Phase is third today in Our OPTIMA III

read track subject III Study you enrolled release, now we’re recruitment. If XX% XXX-patient the press to on complete our is OPTIMA Phase its

year. on I hypothesis know is middle study’s We’re remind learning substantive as analysis will endpoint. you of PFS group next our study, of large week prior based on which minutes from the a the sub you the of The

noted studied. of independent a alone. in treat Institutes lead more or or longer that Radiofrequency planning in the cancer the high statistically significant the In this survival retrospective and a medical clinical It’s analysis potential by manuscript Ablation, and survival. review publication that the some you interested for remind analysis to either in resulted study included perspective and manuscript in impact that manuscript XXX HCC minutes article. has productive I point on RFA it conclusions search in for that the will is the in manuscript been this a all research. data XX this the for and combining of completely is with most in of are intent authors The for author RFA, in is to conclude the dramatically HEAT improvement conducted and journal. my accepted overall of ever improve the National ThermoDox when of overall While in to supported out to study Much sized peer be if you hypothesis Tak, study HEAT heating population data combined legions taken -- Health the minimum patients I published want experience single recently concluded conducted of times clinical should trial. a with persuasive ere intermediate authors of Arsenal the article Professor ThermoDox

RFA of true Now this alone. is not

survival. a crowd. strongly conducted and the this that’s being looked study. two with the RFA in to analysis way heating with conference alone significant in RFA same population RFA, cohorts at at they And NIH’s longer while supported the the the OPTIMA a in in concluded combining OPTIMA or And in statically was study. the and the the RFA overall they currently recruited off by standing So, when was ThermoDox I resulted RFA NIH’s and treated room that by presented ThermoDox last with improvement thesis December conclusion follow-on only This times turn

III and heavy the costs patients all So for this now OPTIMA on budget. for our and Phase XX de-risked, RFP behind is HCC that track The study diagnosed on are newly now standardized in lifting trial guys risked of ThermoDox minutes highly plus of major us. report

data and Additionally, protocol X, readout the quality, Monitoring that recommended of on and the randomized risk, study’s of in final Data safety, note continue DMC trial approved the globe there its XX first of Committee Based including XX% the reviewed compliance April to note XXX minimum minutes regulatory the Europe, of in to way plus protocol the XX at trial review patients revision. HCC assessment Also or that study that markets pre-planned RFP protocol. protocol. major required By the unanimously their the study all XX% the DMC OPTIMA North also compliance as the Asia, without in independent OPTIMA a has August the on data America according across heating completed as time been XXXX. with the the interim presented authorities indicated that and have

ensure look and we’re recognized providing clinical and a local study, high organizations, we all with little, now chain OPTIMA in compliance, and economy. readout. now a and world, data internationally the capable highly is that’s risk management not major with engaged to gross high data operational of to good data world-class manufacturing who of have We cost teams all I see it three that registered and via ALBA two, supply the country also are protocol analytics and CROs us completion costs of behind would beginning practice, as that if the ThermoDox study adherence, redundant margins, any structure one, and the have contract guarantees regions we to quality forward reliable ICH proven summit or but regardless CMO, not producing

which success very by are agree analysis analyses the some many chances study, an good. survival of supporting our including the independent the NIH, you believe overall that have talked you conducted I then OPTIMA about, If just of to here

things in ThermoDox our In for major OPTIMA addition designation study, quality, Europe, the subject extents strategy the of drug is Track commercial on trial, to primary Europe, follows. execution has FDA revenue or review. opportunity focus our China, to on priority in led we to of paid high support these in discussions we Designation received prior has which granted U.S. filings have number cancer market and orphan patients designed and years which a ethnicity for as other markets. the maintaining regulatory for exclusivity successful both among country been U.S., and seven ThermoDox Taiwan XX the by enormous Korea, study enroll each to Based and South sufficient from also provides years, Vietnam. Fast registrational attention which have respectively, liver to the ThermoDox,

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fourth for plasma GEN-X locally and or the protein. surrounding technology malignancies. bladder, incorporated is created for the our into candidate When as in of is marvelous our The recruits [indiscernible] mass. the into this surgical delivery interleukin a platform discussed which DNA non-viral system in Our morning administered IL-XX, invade machinery is each cells even by mini agent developed IL-XX plasmid is immunotherapy. proprietary immunotherapeutic coded we mediated turning tumor topic discussed immune active nonoparticles cavity the fair production metabolic as a the the sustained into like a entry I gene our a to nanoparticle cavity GEN-X's fight cell body body IL-XX immune-oncology entire our cytokine of takeover system. removal peritoneum local factory into GEN-X

patients cancer. when there with this indication diagnosed The less The XX% than first surviving of we're of cancer for years. ovarian X studying is GEN-X chance newly is

have completed study. has X been no is made advanced GEN-X has patients tumor outcome of plus early the importantly that eight the previous reason cancer used patients X. complete have When XX dose. tumors, activity limiting this either of trials at clinical by objective XX% spread, a as responses a GEN-X promising has patient receipted this stages biological and While XX had had results chemotherapy shown or patients shrinking of To regimen the promising in that's surgically complete plus patient this produced most successful diagnosed of at shown called dose. major their platinum with debulking, of surgical has -- cytological regimen clinical we signs XX% positive the GEN-X zero rate, the to signs a cycles with outpatients, dose or X PCR, and chemotherapy in The reception combination control diagnosis is patients. and some cancer highest In efficacy criteria monotherapy XXX% chemotherapy one was Then X highest resist the that the disease population added GEN-X. patients patients XXX% disease the negative and results. observed goal entire and were XXX% GEN-X OVATION Prior overall trial at margin of an and X Phase study zero and response study first We benefit mass. new escalation Xb reception receptions debulking with demonstrated dose according signals. what treated ovarian we the in and and rate dose toxicities clinical response stage in there newly reported the OVATION rate, to to were weekly cycles been response followed our our [indiscernible] of and surgery of recently which taxane three by evaluated X treated the improve clear of

exceeding and months expectations treatment group's PFS protocol going XX per greater strong. than with the Additionally,

immunotherapy These randomized of of reported cells development potential significant. with We we in has both XX% ratio And to the XX in research is also available increased year. September approximately of dose XX% KOLs GEN-X medical experts cells were than that patients presented all this Friday, study the ovarian remind shown findings in translate environment open And in into of continue label The our combination OVATION immunosuppressive release following on population of this the Phase the patients in GEN-X the from in that and doses changes All in almost you predominantly The CDX XX VEGF of and treatment following know be Last is clinically of more receive IL-XX translation to IL-XX suggesting drop [indiscernible] those I/II study first a patients in related appear to along medical to cancer. patient the filed levels, and an Phase that the say I'll from second safety to levels with in is immunological stimulatory. interferon-gamma clinical drop are XX% and board our ovarian data no evaluate want this our line study. XX protocol pro-immune Ib these distinct importantly analyses press as one of patient’s advisory cancer samples. blood production CAXXX and suppressive as greater GEN-X for a for overall considered to the population. to data the exactly are patients dose diagnosed continue changes OVATION therapeutic Most surgery, shift in benefit patient two debulking newly in showed addition. interferon local prior microenvironment same major tumor flow protocol and months. is will disease patient

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with over Jeff? results. financing Jeff our So, will third to and call I our financial review a the recent for turn quarter in XXXX activities to of that, now

Jeffrey Church

Thank you, Mike.

press equity totaled with million of $XX an offering & the and million. total and that issued the third stock common to the raised end warrants in significant July exercise which in This development XXXX. equity financials cover the in the investors During of quarter third the direct $X October the initiatives. warrants healthcare Subsequent quarter, $X.X also of completed execute Company, million XXXX our of outstanding shares which market several projected into underwritten our the of included and third institutional needs with this well our will registered ended continue offering effectively before third $X.X Oppenheimer to morning. utilize we cash million of Celsion's the second shares the of of clinical common previously cash quarter were that XXXX, and efficiently quarter to the XXXX. completion stock quarter infusion this operating warrants investments of issued release capital we was included we we in to We opened as

to this use we of Form XX, September monitor ensure also quarter shareholder morning, Our efficient filed continue value. XX-Q to create the our most cash the was cash for expenditures ended to

million cancer the Our operations squarely clinical $XX.X Operating our in the focus XXXX, in pivotal new were compared of for expenses III nine to XXXX and These to $X.X earlier, I/II in our million was in projections ovarian $XX.X prudent year. remains liver for Phase results are September of as for are the September million XX, XX used the of months was a now ended cost XXXX. nine in ThermoDox the the used and enrollment million, result the cancer. compared the $XX.X clinical third line on for million prior and trial months Mike efforts in Cash operations prior product compared period XXXX. cash implemented GEN-X same during quarter primary Phase in $X.X first $XX.X development reduction the to Cash in in XXXX, ended of mentioned with our earlier tighter trial year million management. focus, that

off our of balance has no the During first company we its year, paid debt on the debt facility Hercules. with The venture sheet. half

operate which lean organizational less continue now We with XX full-time to a than employees. structure,

is research directed spending development activities. Our and to

our quarter balance or per XXXX XXXX. cash and expect to million $X approximately of for operations be used the We for less

decline to number completed by enrollment the OPTIMA XXXX the with of full mid-XXXX. be this expect projected We in to study

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

XX, in loss loss September a million, of quarter the reported a the net XXXX, we prior year. For ended compared $X.X third million of to net $X.X

third R&D R&D costs the to million million, for million for For was in net nine XXXX. period costs million, million $XX $X.X compared XXXX, to in September $XX.X months XXXX XXXX, loss were were a ended same $XX.X our of compared year. nine compared net the the first of nine-month loss last XXXX. in to $X.X of $X.X quarter the months million XX,

cost and cost compared third trial compensation Phase X of professional decrease Our down personnel focused result using million expenses III This X expenses XX% Phase in to the clinical when OPTIMA in X/X and in primarily reduced and decrease versus the lower the the analyze fees. were current XXXX G&A in same $XXX,XXX lower XXXX. period operating the in first during $X.X stock million the on this months of and in and of in XXXX year R&D data of and enrollment of $X.X Phase year. that was and was patients tighter last resulting term announced a in study quarter near focus the the readout completion value premiums cost lower personnel continuing non-cash OVATION pivotal the a GEN-X lower programs initiation those to the same the of professional enrollment help that of in the study are administrative expenditures third reorganization follow-on treatment in due $X.X expense, productions quarter compared and the through from the were million to their treat the This the for Phase will $X.X XX% service ovarian million on and to XXXX X cancer. of OPTIMA was General study. insurance drive and XXXX clinical year -- shareholder period

impairment third product to to candidates. impairment $X.X payments out with expenses of September the indication. milestone debt million related development in by decreased multiform by our and largely charge reduction same GBM related a to $X.X was facility lower in Hercules. program, GBM development other due related ended expense This to Interest the pension impairment the principle the offset the a liability been earn This outstanding for assets products XX, candidate. GBM During evaluated $X.X charge certain in of the our process a balances cancer non-cash under research XXXX delay million product of IL-XX in million represents in the quarter included to or competitive due glioblastoma the

many we mentioned conclude was execute biotech and earlier off our I companies I on As X and business cap the sheet this over paid plus X, stating extremely by to challenging. small are the well Celsion for loan XXXX. balance financing our like has to is The client that full positioned initiatives. June facility past been other years in strong

banking capitalize important tools We are product now the for properly investment have company now back to and Mike. turn well to news financial the the I'll deliver positioned call and success. our programs to support development around analyst future

Michael Tardugno

Thank you, Jeff.

conclude a billion fundamentals just the major $X and our in are cancer of primary and billion cancer. opportunities work market market will both for we looking at that ovarian right, you $X consequence. Because sound I we're is So, for remind are potential liver if our

comments, provide Assuming we're more with two program will session. the so significant a to the in we our either substantial capitalization. to and line limit to that investors. And market the right, that of the to everyone being with successful we also significant both ask designed to both look the With open I'd in than Q&A in prepared opportunity With programs an forward participate conclusion Operator? operator your return lines patients of our questions can clinical in to our treat our to first increase for a advance questions. like of ask you the number establish medicine a


question [Operator Markey. Instructions] And take we’ll ahead. go Please Keith our first

line Your open. is

Keith Markey

questions, Jeff, appreciate Mike, study. was use I upcoming thank the guess that systems I I my taking this issued was morning would you GEN-X it them? was in identify wondering yesterday, you wondering you criteria the -- immune relatively press mentioned that enroll Good you you in healthy patients morning, release for will it. to relatively or healthy like and to what

Michael Tardugno

the part the naïve, effect treatment patients first agents to all are, Yes, what anti-cancer a as for trying of I system. there line immune with we’re chemotherapies most or are detrimental is these communicate know who is we think do have

can newly point was first our line these are patients and most part there that So, please. the on maybe expand that for treated Nick,

Nicholas Borys

true be they’re good for performance we’ll going is have a so to what to at have looking that Yes, status.

on based performance definitely one. So status

with familiar So, you that. might be

is individuals first systems relatively systems exposed immune give status. are the of drugs alter affect could their immune line these that healthy this said and So, Mike, so been therapy, you chemotherapy previous or as haven’t any

Keith Markey

look to study dose was possibly. per specific or sure wasn’t I any began? us disease I at if tell any in could then XX the you. past there square patients if Thank the have meter was that had OVATION something progression with wondering also of milligrams going very were trial the Okay. since you you And delays treated

Michael Tardugno

per At square? know? milligrams you meter XX Do

Nicholas Borys

they as patients know, the the enrolled. to very possible. after resections tumor the As far remove went and of their those did all are they we’ve new the well zero you chemo all they all treatment know means into And surgically latest able GEN-X as that that surgery and that had therapy surgeon I was

So that those was for patients. good news

to We progression follow them and haven’t seen continue we yet.

Michael Tardugno

none would quickly also you died. the that, about ask Keith, that, patients study have add on the of just if I

Keith Markey

That’s Thank you. better. even


[Operator And we’ll ahead. our take Barry go next Rubin. from Instructions] Please question

open. is line Your

Barry Rubin

Thank current share your you. count? What is

Michael Tardugno

is share Our count million XX shares. approximately

Barry Rubin

is to from going there one? any any future dilutions be And

Michael Tardugno

not anticipating want you could ones immediately, any far as but to We’re do talk about money. that? that Jeff, as be But

Jeffrey Church


to addition change. have XX at which and In $X the approximately we X warrants strike about ranging are million outstanding about shares from million to prices of various $X

shared about a basis, So, diluted our outstanding $XX million. warrants, it’s fully on

believe rate enrollment we diluted to So, very diluted $XX but attractive us can always we’re opportunistic, XXXX well second study basis. million outlook. fully a into at and second done certainly To of on interim indicated not the it’s that be are now preplanned $XXX but a first right million OPTIMA going the on a basis. into but address to raise of going as said the cost we the a mean, cash we run beyond it we capital, have be never additional that fully the quarter capital, point, We takes of I

Barry Rubin

second the question? I ask May

Michael Tardugno

now a Phase point III, year a precipice first just ThermoDox important was in is virtually enrollment, you away I study know, it’s would also little think this, our from I over interim rate. at of out concluding the an the

So, sure we’ll in it’s continues in GEN-X, be saw -- show interesting. it kind clinical very trial, we first results the the will that to be of showing, I'm

to So, our for I be we'll means improve non-diluted guess that cash looking also balance.

Barry Rubin

question? scientific May I ask one

Michael Tardugno


Barry Rubin

difference between Okay. their if [indiscernible] seen but liver If what’s be and correct what wrong had cancer, the press had is, may just for I'm product the approved a yours? I’m that’s product in I I correct

Nicholas Borys

this look I’m have the got trying the an believe product approved. recall got but to that advanced studied HCC. haven't approved I I I it, that lately, into mean, they something to that that product is is I they

which patients We’re population. and by far the newly are largest HCC patients diagnosed looking at that is

So, it's population a we’re products. targeting patient that two between different

Michael Tardugno

I that of you in and currently a phase often explain effectively, on [indiscernible] an many for as medical our can on adopted tumor that many or out, very about we’ll similar would the know the surgery we in phase actually first-line or and very bit, time will little being I combination as ThermoDox development and III take effectively way on me evaluating that asked some that and that are In in in radio be a countries long heat. view surgery. for multi-kinase around ThermoDox adopted cut will, can around that and and you treatment. the this, a bullet have is competition to the predominant ThermoDox it what is And long a with eradicate without that alternative are Borys frequency [indiscernible] Let quickly, tumors if a we our promise world with you same what talking burning very first-line Dr. effect you we’re time. in it And be Phase treatment, is magic will. the inhibitor point was there are treatment drugs an none is. showing believe pointed and by first-line indicated the competition eliminate for the [indiscernible] who patients this is oncology for that and you we if as none this world about kind know ablation, for is, of off, The at societies ThermoDox continue as can


we this [Operator Instructions] And further at no have time. it questions appears

Michael Tardugno

look us. our Thanks session. your oncologic So, prevalent our to want you to some updates And highest Celsion forward unmet all thank of very delivering for common I innovation development we joining about need. support as to our cancers we'll of goal With your we close call. therapeutics again our that, the with continued We for pipeline. value for address of the advance and most for remain providing chemotherapy future interesting of of our the again immunotherapy joining excited We programs. potential


for does This conclude Thank program. today's you your participation.

You at may any time. disconnect