Celsion (CLSN)

Kim Golodetz SVP and Principal
Michael Tardugno Chairman, CEO and President
Nicholas Borys Chief Medical Officer
Jeffrey Church Chief Financial Officer
Khursheed Anwer Executive VP & Chief Scientific Officer
Kumar Raja Brookline Capital
Call transcript
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Please standby, and good morning. My name is Nick, and I will be your operator today. At this time, I would like to welcome you to the Celsion Corporation's Second Quarter 2021 Financial Results Conference Call. [Operator Instructions] At this time, I would like to turn the call over to Kim Golodetz. Please go ahead.

Kim Golodetz

morning, good and you, everyone. Thank Golodetz This LHA. is Kim with XXXX and Business to Celsion's Conference Results Quarter Second Welcome Update Financial Call.

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

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

Michael Tardugno

morning, Good Kim. you, Thank everyone.

are who Celsion's Borys, review today our and who questions in Medical is initiative. Science will Jeffrey our Chief Huntsville, Officer, provide financial available Financial Officer, recent announced who Q&A Chief Nicholas will Church, of Anwer, be will discuss me the Khursheed Dr. our our study; during results; Officer, Joining a your Chief vaccine Alabama, X OVATION regarding answer recently our to session Dr.

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Nicholas Borys

very Thank much, you Mike.

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Michael Tardugno

cancer in Their outside to just GOG. Gynecological Okay. represents of think is Thank institutions continue you. interest we trial States as the the very The a our the overview, important usual. and make humbling. as XXX States. quite ovarian Nick, like United about And comment Oncology sites our for the investigational I important great over most the some of in would a United Group of I work.

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Jeff. now, So to to call turn with I'd the that, over like Jeff?

Jeffrey Church

Form in Michael. cash second Thank morning cash company are XX-Q, in the approximately million losses. restricted quarter results securities, filed $X.XX we XXXX of cash the and The $XX.X investment the of before market opened. operating ended Included included of second quarter proceeds and million this from with Jersey Celsion's Details net release receivable. and the financial our issued unused of net million this you, we sale press XXXX accrued today which in May in amount received in our interest is New $X in

to available several through provide current see have and an have expenses raised value-creating us And sale from million for company the a And million to At Over operating as a New our to have through these we nearly cash to important Michael milestones. XXXX. operations of NOLs the XXXX runway past nearly X which levels, is full Jersey we $XX year's years, said, unused funds NOLs, fund between these spending XXXX. $X sufficient we to without equivalent the any sale of additional investors. dilution

to Let second the financial a me half of quarter results. and the turn now XXXX first review

of and the quarter. in decreased company's $XXX,XXX with OVATION to Clinical associated $X.X manufacturing clinical XXXX, the from quarter. per support of of $XXX,XXX as costs to $X.XX compares ended development is million down costs $X costs from program. related expenses General expense share. for technology were with OPTIMA Phase for decreased to the quarter compared of expenses, by DNA-vaccine quarter Breaking $X.X of expenses prior million to Research the of year. trial of operating a This million fees quarter ago, related year the $X.X June quarter net and million XXXX, III R&D loss quarter ThermoDox or by well the a the of Celsion $X.X of per $XXX,XXX, million costs this year. to attributable the is million the expenses administrative professional XX, year $XXX,XXX in second study quarter item. the $X.X second to prior lower the about this compares XX%. compensation GEN-X ended platform for of line regulatory For and last and for up $X.X Other second million X Study XX, Operating increase development this the the $X.XX were programs previous were to $XXX,XXX or current as million low the of net an of new reported in for interest during months both the facility company new X with The capital. PLACCINE compared $X.X million quarter operating loan Horizon loss runway on rate debt stock increase year This the of months or $X.X net noncash XX% which of increased for for was retire decrease or primarily year the This million quarter, quarter. loss for the the due Bank and in million and into an new second interest in June higher of Cash line activities which to the last which We Finance X% and premiums XXXX. for close to utilization with call million an loan they XXXX. approximately of to a a $X.X officers' $XXX,XXX half development share used second all $XXX,XXX Valley of increase cost a million related facility Valley I'd the million, with in NOLs. comparable $X.X $XXX,XXX the in XXXX and outstanding was our and rate $XX entered provided insurance April year XXXX, On year, provides Mike. from to Technology now used a $XX per period, facility with $X.X an of prior incurred Silicon to cash interest for of the with close activities of by from an compares million loan at in proceeds $XXX,XXX. of indebtedness extinguishment. to our year-to-date $X with $XXX,XXX operating interest. X this resulting to New average Celsion June during million cash like million first expense a financing and In Horizon the to offerings is when Horizon. basis, equity projected $XXX,XXX in largely of the XXXX, back $XX Jersey of turn X%, our venture January sale Silicon carries the to $X.XX very Bank loan the director This recognized to compares Corporation. debt over a first facility line

Michael Tardugno

prepared by overview. need in patients remarks and potential Good we value holds benefit underscoring believe Jeff. over to create I want our that Thanks, that close shareholders. for today to Good our great to Celsion view.

life-saving reside and to highly Celsion. remind medicines it's of clinicians are we the of We bringing of market. team to anticipated helpful When all within that assets look ahead who have researchers capable a committed accomplishments, to you our to

technology We nucleic versatile than have a platform, exciting platforms personal and acid area technology one the of medicine. more

Our drug competencies span the scope evaluate is of required candidates. what rigorously to

support exemplary. regulatory and and both management, promises. States capital United in States and with are deliver cash we sufficient our outside And the on in smart our Our with time to great have spending, lines relationship United prudent the authorities science

meetings between to conference. want questions, hold and Wainwright your and this at the open your presenting to one-on-one virtually. H.C. you and at to virtually forward participation the held look present XX be XX. September will We we call We Global we that meeting mention plan Before being I year Investment the to investment Conference

to that So overview the of business call financials, questions. like and now to with our we'd open

writing it over a do to I'll address I we question upfront. that have I think Before turn operator, the

Michael Tardugno

have question some I before, The application good GEN-X I is more with we've we and a cancer? to you. for detail stand addressed where ovarian share do in with but probably think it, This breakthrough believe, we our question, status

ovarian study our patients. validated, with breakthrough for -- mean, patients. in a a Fast to our did I from when briefing but endpoints intention they're While that data quite a cancer, GEN-X and for have designation. evaluate trial data same then breakthrough for for complementary study, In meeting a short of result time. that proposal to know very encouragement status. from review ago. the some we to additional submit our in review, might meeting the the But once the a submitted to very evaluation a of strong the suggested data for to They primary not community. were not the -- The breakthrough indicated clinical a back cancer in newly outlining too we that more We We for our FDA Fast design. we're us took FDA the enough data way investment close. status designation, Track But long breakthrough group. with II a to They Phase random. breakthrough consideration. preliminary FDA Phase in of a additional that submitted they in standpoint, document approved our research, it's screening clinical guess, did Designation, for Fast as, diagnosed the of announced enough proper may concerned our the them Phase of the they was continue the getting not provide and our control the in as I advantages status. additional synthetic meantime, data therapy -- breakthrough patients data study. Matching for what quite not best likely our that arm, control from on we assurances us again, not I in work single-arm we will endorsement to a -- us the would I we reapply few having yet submit have our in In you very once We was Track the the to have as many to that we approval as FDA application suggested step were ovarian But application with agency. status intention, study compare impactful thought be breakthrough qualified seeing with consolidate treatment the that our Phase advantages who the might our patients had a not arms was with II synthetic strong a to an Phase come to treated very and the patients randomized I includes from encourage control gives They that the basis, we It with otherwise matching arm. agency, applied we gives meantime, had us Track a status We we which study, practical conversation

So think can with from that, operator, I meeting we questions on to attendees. the attendees, go


Capital. Kumar comes question [Operator our Brookline first Instructions] with Raja from And

Kumar Raja

And also congratulations on all the [Indiscernible].

facing your regard pandemic trial the in with of with we board, on we with future thoughts GEN-X sites that? So to regard are where the again, the to ovarian number what the And are enrollment? terms on stand of do

Michael Tardugno


years. would investigators I'd -- as being characterize question. this person trial we've best and in our the probably what is some among been are. the it answer Nick enthusiasm think running to just said, That expectations to And now with team of I the I proceed gets. clinical a like trials here our sites together business just as good the Nick, for XX,XX as So

Nicholas Borys

pandemic you We including your everyone, research patient cancer very that has an saw enrollment. impacted and question. our for clear Yes. cancer in the Thank increase much patients. It's

back follow-ups. I PIs. checkups hold the all calls we example, we was think may going regular It our But again. a For like tightening with pandemic for conference be result patients and in and June, of and it their easing looks

As don't we're doing enrollment. to continue other best from one have studies. Luckily, too and current competition to all situation, a I yesterday our we had much of the matter review fact,

So a OVATION lot the of focus is on study. X

In are recruiting patients sites, terms have U.S. and moment of Canada. believe, over our XX at the in sites, both we I

site and there. opening screening in Our most was number New Albuquerque, a are Mexico, currently recent of they patients

we'll hopefully, going objectives patients hard continue our and time lines the the pandemic all in. meet getting and for we're to So working through

Kumar Raja

involvement Okay. does investigator-sponsored there? how And trial, the with to Celsion regard have much pancreatic

Nicholas Borys


the the We in protocol of of issues We're we're study safety. supplying So product involved on We've closely consulting in obviously we're design. were any working study this in that the is with very with England. the terms University and study worked supplying Oxford team.

enrollment moment. So I'm certainly for at patient if enrolled but they've they're sure the not yet, their open first

Michael Tardugno

little that, mind, I'd like add you to a Kumar. more to if bit don't

Board with and energy Andreas one and director, immuno-oncology, decided Managing working our -- property Director. to of Switzerland are been has have immunology of Fass, Celsion So all assets He has of for our of majority its in focus our that we've is named placing on established the recently managing we intellectual in announced vaccines. We've physician ThermoDox a members the Zug, directly. along subsidiary Zug,

management will I'll to and team through immuno-oncology our relationships distract the The support thing. So be clinical from of one these Zug immunology more Managing Director, trials just our it's not coming through [Indiscernible]. and and the vaccine programs. our for Andrea say Celsion

to We We a we is So a impact activities be sure it ThermoDox have a want cash our the significant so. -- do we're seeing support on these is significant expect to budget small to do unless to that for don't do activities. reason have there position. any reason our to support so, and

Kumar Raja

Okay. Great. antigens multiple vaccines, the to using mentioned about antigens. With you regard multiple

antigens, you some they the maybe seeing provide been So can what guys that a in with companies, compared expecting. are is antibodies models? And are other lower single has what have with neutralizing on we thoughts your antigen. using seen What comparatively us some experience to you multiple preclinical

Michael Tardugno

please? So Khursheed, position question, in to are answer a that you

Khursheed Anwer

So Kumar, that question. for thank you

in response to are building the seen we of our have We have antigens. still multiple process vaccines. immune composition -- of we different And

to plasmid in been protection assays. where are some -- maybe respect that some to a gotten of and expression With using lowers second of people of case known, antigen point ways haven't bridge iris the what's utilization are You vaccines. there subunit

I approach So a HIV well. at people least shown have think multiple antigen-expressing with DNA-based HIV, in

we able benefit. we point hopeful haven't we're that confident but gotten be that should demonstrate to and yet, to So


additional for to Tardugno call Mr. over at questions back this the time. turn I'll have We no closing remarks.

Michael Tardugno

and in have shareholders Well, interest out you I these ask that them speaking for other time your your communicate forward find you to you your thank we to do are calls. a the to to -- us -- you We to we participation. going in certainly you very investors, we much, you And we and appreciate reach Celsion. our want with, we morning. any if thank to look participation. know conference to all this encourage increase We're way with enjoy encourage join investors you to

our bring Celsion, to continue We driven like that, our to new forward at the progress say And our to appraised with look exemplified our medicines year. patients we in and scientists by by staff. and be I'd you and to this of so to technical commitment And keeping that need. talented work throughout clinicians is and

you you We on important of up be outside that that can count bringing information. the the have us events If will are quarterly any speed. you to make to regular meetings, sure

Have So participate third your November. financial have with Virtual in day. again Wainwright H.C. XXXX we when you you to report upcoming results And again. be that, quarter we'll a a hope rest Thank our in speaking reason we if to the of Conference. you on great not,


call. And this Thank your for you concludes all participation. today's

disconnect. may You now