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Celsion (CLSN)

Participants
Kim Golodetz IR
Michael Tardugno Chairman, CEO and President
Jeff Church CFO
Khursheed Anwer Chief Science Officer
Nicholas Borys Chief Medical Officer
Kumaraguru Raja Brookline Capital Markets
Call transcript
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Operator

Please stand by. Good morning. My name is Olivia and I will be your operator today. At this time, I'd like to welcome you all to Celsion’s First Quarter 2021 Financial Results Conference Call. All lines have now been placed on mute to prevent any background noise.

there a remarks, session. speaker's the will question-and-answer be Following like time, the [Operator this would to Golodetz. Instructions] At Kim I turn to call over ahead. go Please

Kim Golodetz

Golodetz Celsion Thank LHA. update financial conference and good everyone. business is you morning, results and Welcome first Corporation's Kim to call. quarter XXXX This with

the a has question-and-answer As by Celsion’s will remarks and practice prepared been session. be noted as operator, followed by

Exchange to revise Tardugno, said, President. the by comments turn pandemic. of broadcast, required for of of on based CEO, I'd be to caution Celsion’s including in can filings Celsion operations, change management Generally, time COVID-XX results, These expectations current be other risks at update statements about statements company's live by no can May and This there forward-looking as to or results subject and of about call, be is best financial the the outlook making over or impact that will today's information Michael guaranteed to forth and set number and date this and this expectations uncertainty significant obligation the COVID-XX discussion. as those particular, and content during regarding differ is During XXXX. the I on statements such only Celsion’s statements. of call events. the like uncertainties the In contemplated projections No the the duration future such means statements Commission. estimate results believes, contemplated on materially actual expect, identified that is from Michael? terminologies except forward-looking call forward-looking and this Securities the accurate XX, and made are and may could periodic impact with any also conference the With law. a as are anticipates, of based expressions. Chairman, call similar undertakes

Michael Tardugno

morning good everyone. and Kim, introduction, the for you Thank

Joining saying will very and is first our want of clear Chief Financial during sound. our Medical report our address I weeks during to Science Church, and the this who to XXXX. Q&A financial for me that results; Khursheed Officer. It's achieve to regarding me today objectives the to development Nicholas I'm Dr. our company start will Officer, vaccine on of relate our to review you quite to pleased Chief Celsion a evident. by Borys, our Dr. questions clinical recent our is Chief the that the announced progress who recently provide the Anwer, of confidence are well initiative. I'd remainder Also like beyond and and Jeffrey call quarter Celsion’s on positioned our year is is subsequent Officer, fundamental,

vaccine platform is advancements new This multiple of significant is being for technology a our with the proprietary and Phase Phase is that. data product - from ovarian to mRNA a first and includes over cancer. II vaccine reasons which the some incorporated promise as viral product of on smart platform our vaccines. Study, this efficacious a supported platform. advanced adaptation next science single evaluated our the and PlaCCine, is platform immune generation based TheraPlas, our an application on in support TheraPlas for a plasmid. within In hold from our OVATION technology generation I are Here proven antigens which clinical into lead studies by modifier may and designed compelling GEN-X, highly

reinforced sheet professional drug complement are development. team These balance individuals and of extraordinary staff capable the company and of but PFS major being Phase X very impact sufficient of straight are funds over first anticipated million, solid minimal vaccine data with this financings progression with well balance industry. months execute milestones, last conditions stock expertly to immediate our thoughtful research in for have to the and year strengthening through cash rigors equity recognized capability II and including be OVATION And not We demands development markets and us Our immunology to shown four the well ensures capital $XX Study. to permitted with of in in the experience individuals whose sheet incredibly a this shareholders. smartly raising a into development rock least, during and the see survival our achievements our following or free all from global tapped market

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goal ovarian tumor possible subset GEN-X fluid too label trial patients. much whose surgical Our OVATION patients is This accompanies that OVATION The is care chemotherapy. for advanced immediate is to of cancer GEN-X results. of X the combines which a cancer to Study open and improve as randomized with mass X tumor in neoadjuvant of burden is treatment-naïve the great an as of intervention. surgical shrink the drive standard

of GEN-X chemotherapy GEN-X and of undergo combined GEN-X surgery followed That's which cycles once weekly and additional adjuvant neoadjuvant period. XX debulking eight-weekly is Following treatments. chemotherapy, then up neoadjuvant a weekly interval patients chemotherapy to by with three treatments cycles nine over six-month

this X of cancer PFS sure patients XXX progression. an an study. outlook. not however in was patient X.XX our of expectations, blip up to Borys, XX% the you Our XX% one. want in group disappointing progressing Dr. but been an which enrolled improvement to our portends the that a recover anticipated that for mean ratio are bleak say study know is I progression do approximate would with goal to That I the in this in and seem risk We're the is April confidence for delay The said, we're having from not month enrollment. study large PI; behind a is OVATION call, because interval no the what Dr. we was to meeting designed XX% Foundation. Saker GOG taking cancer observed and X progression immediately lead hazard chances The following with with Advisors

approval. track among experts other path and recent is the authorization. exploited we significantly with that to track our fast designation supports FDA designation have timelines ovarian to to take to Fast from of brainstorm goal of things improved advantage reach ensure group Our cancer an this market regulatory our to

Now, GOG a and little Foundation bit the more GOG about the Advisors.

organization quality funded Foundation in field a of in of designation brought influenced purpose malignant the with organization by Our neoplasms. States sites. of to track clinical Foundation. the GOG basic of attention The have excellence the the the comprised GOG more is gynecologic trials the in fast of is promoting the standard leading gynecological XXX network the of scientific for the and than This malignancies. Clinical and in fact GEN-X trial oncologist of care and a numerous United research gynecologic non-profit integrity has

the RX XX in to large with the resections the GEN-X We're RX near in XX% X at results with data path in delighted patients reporting rates of OVATION OVATION organization's the attention now treatment OVATION the XX.X% dosing our compare similar far. XX%, encouraging as study. the chemotherapy work. we're neoadjuvant And where it RX RX have is to study to neoadjuvant our and data isn’t of the we and with two hope survival meeting believe mean compared first Phase of we XX% the control arm oncology cohorts showing which We've in strong under treatment OVATION resections which validates But alone need our of X trial compelling X earlier designed predictor earlier rates arm regulatory XX approval GEN-X the to journal view - major with good the at why our approximately the review I X X the results care study in arm. reported I zero rates the frankly, in RX reported alone standard a is and come purpose this RX and are by to a comprised accelerate historically, seeing that is of chemotherapy These very as in also highest patient or XX Physicians of to-date manuscript study. patients attention? have observed escalation come X Our their A the surgical further resections comprehensive control two of has currently in arm population. favorably published future. the the papers of said. as in two the resection dosing the [indiscernible] been clinical resection wouldn't to thus as are - for that that this our approximately medical in control show is outcomes. involvement of XX% many GOG or arm GOG’s

from well speak an a investigators interest multi-billion dollar Avastin fund think oncology I been in combining inhibitors there's other note, approved and final One used that for Avastin. cancer second-line patients. now ovarian in presenting data checkpoint GEN-X are and like clinical as will expressing - as treatment growing attention investor itself. treatment paper the investigative regimens managers for strategic drug the genuine is with we

excited of supporting for very to of the months. potential combination hand the providing all the we agents about look GEN-X, trial with we're GEN-X prospect upcoming other in So with forward partners and

initiative. our I'd PlaCCine to like attention turn to Now,

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and heard we CDC the that acquired by causes evade medical experts concern As ultimately may alike, the viral it vaccination. immunity variance from

immune a representing M code recruiting of antigens, protein system, In primary and a summary, system. the a also longer COVID-XX of the two or at system proteins, are antigens is viral virus our backup a design primary also, no includes we recognized combination. I same our is So, a potent two is as providing strategy includes design powerful an IL-XX, body's S system that three accelerator. in recruiting mentioned backup, event for membrane code believe And the the and the for antigens, one immune our by immune includes the a earlier, immune two which protein the cytokine, design time, a

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and of hypothesis the our a clinical using projected and goal our vector preclinical commercial the to we proven, seek to as trials. DNA its partners there intend as mRNA multi-cistronic to for is capability approach possibility, comparators, demonstrate if First delivery is studies immediate Once validate vaccines our and and hypothesis our advantages. development technology standards, is COVID-XX

importantly, or seasonal more even development begin the range herpes example, C others. a among is agents and of influenza viral simplex, hypothesis or Hepatitis proven vaccines our Second to for broad infectious of once we'll other address

is infectious be potential a the our and us, IL-XX and to horizon of Third, be has a and run Combining revolutionize the both vaccine could our - advisors with truly the believe, therapeutic that potential may technology world to therapeutic. be has Developing prophylactic I that the something disease. treating We researchers breakthrough. the and antigens this of excites on real most. the

so is far quite progress encouraging. Our

I As a we've provisional mentioned, patent. submitted

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our perspective, And updated. to to much in over these call more there's Jeff. developments future. with promise to is from We very folks. turn near the on this the Hopefully, exciting that, you So, keep I'll come

Jeff Church

The market of and ended the the net company $XX.X of before Details financial early filed million cash in stock morning quarter. we XXXX Michael. Jersey are common press during included raised first our you, quarter cash and opened. with today additional XX-Q Thank the this the we equivalents proceeds issued for first which Celsion’s quarter second million in receivable results Form losses. net in release New an of in part We from sale operating a and the $XX.X sales the

New we unused announced which net end quarter. of also the million booked from in the approximately that received proceeds is selling earlier Jersey our $X million we the losses We operating cash this of week $X.XX receivable net at

company sale of have $X any spending we current And of for XXXX. cash shareholders. unused to million Over full available operating almost future. we to past of dilution fund have expenses operating an equivalent net the sufficient one sold At in $XX NOLs the levels, additional years, the operations three have we to without losses to million year our through

several as Michael value sufficient have to milestones. indicated, we runway through So, us creating see

now results. me to first financial turn quarter our a of Let review

exercise expenses technology share. study III or vaccine decrease $XXX,XXX, $X by This the to last the For this expenses the million administrative million year the the OPTIMA were the up emphasize, were lower compared for net $X.X Clinical of was by non-cash to the for the quarter programs prior from of were million used XXXX by XX, company's for reported and to Research of from to Breaking the the and $X.X first share first manufacturing or primarily $X.X item, $X.XX or quarter in primarily common of costs the an quarter with development increase the quarter for net the officers I is million This common first $XX.X million comparable operating stock stock compensation $X $X.X company a quarter attributable March compared down to year. to program. $X.X PLACCINE $XXX,XXX in the proceeds for warrants. of our first period $XXX,XXX with same in of of support Phase from million insurance. $X.XX XXXX in XX% activities of first the expenses million per million million per in first stock It's ended quarter $XX $XXX,XXX approximately compared XXXX. in $XXX,XXX $X.X cash net increased related for XXXX. This higher for about ago. million of year clinical the was year million loss XX, the to quarter this and This line a a $X.X $X.X development March development activities professional costs quarter. the of sale $XXX,XXX costs non-cash, XXXX. expenses fees of ended related and of decrease million and Other XXXX, $X.X research regulatory quarter development and XXXX million well financing compared in costs the of compares of is due the resulted by loss XX%. increase as first director to Net which period. million the an on of $X.X increase the cash year expense the development Operating quarter. from for to and associated a from study first year quarter in DNA of premiums Total platform prior General ThermoDox provided II to OVATION GEN-X first quarter. the for decreased as operating about this

to the I filing. to annual recent wanted the company's our I X will of Xth. Three call over proposals. April plurality four in on is close votes of vote routine back meeting of of business Michael, Before to June for shareholders are highlight require asked these shareholders’ the turn pass. proposals And record cast and be at proxy a on The to only Friday, scheduled favor

of shares However, The of such associated of increase XXX.X I'll to the and favorable and of future shares a to company additional by that shares each of undertake greater Directors a XX.X technologies would holding outstanding availability proposal time million - the development authorized at shares of authorized include requires candidates to a in our permit shares. three increase or and stockholders with as company number the anticipated management the will expense the equity actions shares without opportunities respond on as million XX% XXX.X from which arises. proposed acquisition The Michael. more shares call past provide with growth to believe of will approximately ability three approval record Proposal the than arise special the provide needs to that, consider meeting us to outstanding vote million currently the product new stood will well support financings. Board an to the date. the proposed turn With certain shares flexibility as obtain and stock-based opportunity these they and business back delay will with

Michael Tardugno

balance your to a appreciated. very with to I sheet Thanks, strengthen our work publicly investor-friendly is just Jeff. And approach want well say

Jeff Church

you. Thank

Michael Tardugno

what reemphasize just Jeff your noted, to want just vote also shares. please I

dependent It's vote out your As your website. never Jeff to capital approval been to proxy, research our to the on instructions upon points how you support your increase is authorized easier shares. to shares. additional vote our have access to via In

you've ballot. your know You down this mail can also pencil, ballot, you if take And number. let if a your lost have please in me

and Please close You another XXX-XXX-XXXX can you Celsion shares. for underscoring prepared telephone value that want patients potential We'll holds get vote remarks shareholders. to our do call great one, to today create need to your us. XXX-XXX-XXXX. I our benefit number by that’s in

So committed have often, as I've researchers who lifesaving clinicians capable of to medicines to market. we team bringing and - I've a said are said highly

ahead that look we to anticipated of it's company. reside to of all While our assets your the helpful accomplishments you within remind

technology exciting therapy and versatile have We nucleic two platforms area, and the acid vaccination.

to what's evaluate of spanned these candidates. competency Our vaccine required drug the scope rigorously and

and good Our relationships to in outside and And capital get. we medical community United authorities in prudent regulatory advisers they and as both as promises. have sufficient medical with deliver management, States on spending the the cash our are smart with

financials, I'd of the questions. Olivia, with So that to please? and open business our to you our would now the open call like lines overview

Operator

Of Markets. course. first go coming question Brookline ahead. is Please Capital Our Instructions] Kumar with from Raja [Operator

Kumaraguru Raja

my taking for questions. Thanks

maybe done plasmid an - know right expression will now, this needs uptake dosed done, intramuscular us as we stage to be what we First, what the humans? about are do this expression injection? in needs with be the tell regard cells? in to before those what PLACCINE what And to can this can be of be you platform of about And it

Michael Tardugno

questions Khursheed I to So, the these want maybe or of with answer can about to up finish things you some - line. the couple and answers the Anwer on is a Khursheed, questions. to say

with preclinical understanding IND. discuss the expectation that's preclinical an to is our The our proof-of-concept. a an work is of meet program. that have for we complete have those the IND proof-of-concept, to clinical the to still to And sufficient goal And once we're agency requirements our requirements support ongoing phase is work in establish Kumar. we early once to as So, development, intention

the fourth an application have - late the this in the agency the early around hope early meeting the with with and is forward is a first we’re ask with that third in jump methods to the that, year in. in I'd regards Khursheed? year. administration, like and to of expect we're next what of or quarter evaluating of approaches. Khursheed to multiple our encouraged routes we very do year think IND With or move to to quarter We end And

Khursheed Anwer

Great, thank for that you, could Thank you, administered. as Michael. route are Kumar, delivery said, vaccines Yes, we're question. that of on your based developing Michael be easily and conveniently

other So, more as DNA, we’re the so intranasal and by muscle taken intramuscular into lymph - the eventually lymphatic uptake to looking also is the is and DNA well. up at to also as intramuscular node. would cells system the subcutaneous The our in muscle routes by injecting the DNA cells. program Both but - muscle such lead formulated

We from GEN-X plasmid. have seen that our

we antibody cells the then T-cell-mediated the MHC and up the leads essentially, through antigens believe could be Class So, that cells these cells to secreted helper so molecule could muscle protein And and response, outside the X also lead taken by the and dendritic then will antigen-presenting could response. responses its express B-cell formulation it muscle. that surface itself be pick on

immune multiple causing up types the in DNA a and downstream be involved the that cell and could responses. it's So, expressing picking antigen

Michael Tardugno

- a just I Before it. to add like more on little - bit just can I

remarks. prepared So, big in I breakdown about my the is here, Kumar, what spoke

expression to the single the And spike think of It's proteins, our a I IL-XX. form development. this us a subunit presence promoters. models. antibodies of multiple actually pretty whether in tell that's we neutralizing M- move and we're encoded for into ready basis the should sequence plasmid which the proof-of-concept right, next with is some and antigen. of if two now experiments for our we're also And is of protein encoded the of This mean plasma - four a well-designed to animal not forward have seeing eventually antibodies we So, breakthrough the is demonstrate or

a with potential. breakthrough single this plasmid excited have shows this So, frankly capable to highly we're that

Kumaraguru Raja

remarks. Okay, in seeing sites? GEN-X about thanks. little different variations the talked what this of And moving to kind prepared terms enrollment, you on in a are of in bit You

So how these are you trying sites? enrollment in to optimize

Michael Tardugno

concept think in it pareto study it’s - is so, I well virtually a itself every to I clinical plays with. mathematics. Yes, been just involved that not that's mean unique we've

are be of So, about XX% of to We our one activated. patients more sites have XX% in we active, Canada the sites. currently XX get from about

put encouraging. seen. very been COVID-XX, There been Our patients is April, the place the goal that that our of and some to add is - additional this - controls that GEOG discussion last there some network that The into other the that to they've restrictions limiting trajectory with if the months, and other within investigators with among call two up the there their is - patients hospitals afternoon l are discussion Advisers the it are March with maybe explore the some until of recruiting opportunities number mean, associated - network sites. of anxiety had among

So, rebounding seen nicely. seems very to be May said, as we've a disappointing But I April.

end good. here. period. time more enrollment to very chances we've About of So that or But XX to the much I'm that pretty going I recruited patients And to in ask Dr. Borys achieving that of the patients in about comment before And back complete us the got are think on year. time track think objective to XX recruit we period. we're

Nick? So,

Nicholas Borys

direct as I We're field out of comes only thing into GEN-X prepared more directly investigators in that also, also some do outreach. studies. also with in his more Mr. not in Michael professional potential add will investigators. patient with also that Tardugno’s it's agencies discussions working we sites, patient recruitment in attention provide our but we're only are the increasing to And could the specialize that we OVATION data that X our that to And mentioned frequency now are remarks, Yes, studies. with our the with think employing with comments the about We information more patients. gain activity once regarding communicate

those on, nice So, as to going I on. our see time a in going think we're with recruitment activities bump goes all

Michael Tardugno

leave with facing to we study means. want failing by the is don't that Yes, you any impression we are that a

I out, any not to mean, particularly environment getting COVID-XX think I patients and and in study tribulations understand just this trials these of are we we think, company. dynamics point think don't And significant to this honestly, I the the we enrolled. unique we delays recruiting fully want expect in Kumar,

Kumaraguru Raja

what Okay. data you immuno-oncology agents? in to, moving GEN-X know, measure you the terms have with this with to of, forward would combination And initially, Avastin combination? preclinical and or or regards know, plans, Thank what regard with plans we data do And combination finally be analytic you. with with the

Michael Tardugno

I So our of our to talk preclinical combination be data. - some okay, excited Khursheed, data, think very you'd about

Khursheed Anwer

of clearly, Yes, results by interesting a combination effective some shown plus delivery IL-XX but GEN-X forms much multiple Avastin could checkpoint the published growth Avastin perhaps synergistic really cancer could inhibitors, in basis Avastin extensive fact convincing When multiple we mouse in chemotherapy before. lower road have doses response so we of of model. of study. of synergize. in ongoing GEN-X controlling in mouse a dose different with data that and been With with the that investigation clearly, of multiple chemotherapeutic not Avastin that there’s down of - found got agents convincing with we genuine been lowered. itself we But the at suggest in with to ovarian at the was data has there have set are a experiments Avastin, There be in is combination and good synergistic we the that response shown in data is doses Kumar, some course. so us, combination preclinical or with done form therapies combined the have

the immunosuppressive, of have a that immunosuppressive ovarian intraperitoneal treatment point conversion here we cancer, cavity think GEN-X I seen So, of a if environment into is a immunostimulatory. with very highly

be there, because Now, that are would where T a environment, immunotherapeutic require condition, areas they're conducive that suppressive to that not in work. don't checkpoint they example, active. to in inhibitors any live for cells agents It's not

IL-XX know that. don’t still have we So, does the

we you, as inhibitors Avastin, ourselves. data, So, of OVATION these logical immune data that we told seen some and have I profiles these with such as think combinations based on checkpoint are have I

So, GEN-X the in about could possible beyond combination these the down are be or avenues thinking developing chemotherapy progress. where the road that's venues we

Kumaraguru Raja

much. you Thank so

Michael Tardugno

Thank you, Kumar.

Operator

today's at conference I to you this final you. for the turn Tardugno, Mr. conclude will That remarks. time, Thank question-and-answer back session. will any

Michael Tardugno

your say the you want to our to in need. morning. to Celsion, scientists and bring time and our At driven exemplified be to medicines by clinicians and all by support technical Olivia. patients talented again I this work is we staff of you, continue for thank our this Thank now, just our people. commitment vaccines, And and new

second XXXX good absolutely appreciate we investors the are Shareholder August. of our committed June forward you And support your of We keeping we speak the the community. you on Annual when quarter We Please we'll we financial again and apprised and Thank meantime, shares. our Meeting progress forget, to in Have our have the look a you Xth. results report the day. investment very to year. In fully don't throughout our vote much. do

Operator

call. conference today's concludes This Thank you. participation. you for Thank your

disconnect. now may You