CLSN - Earnings call transcript Q4 2019

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Operator

Good morning. My name is Shelby and I will be your operator today. At this time, I would like to welcome you all to Celsion’s 2019 Financial Results 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. Instructions] [Operator

I Please turn go time, to call like Golodetz. Kim ahead, would this the to over At ma’am.

Kim Golodetz

its Thank Welcome you financial discuss to everyone. results. XXXX Celsion Corporation’s and conference call good morning, to

Celsion’s and practice be and tomorrow will for through available will a website be Celsion’s been and by available webcast has as by will replay prepared followed conference the Today’s period. XX XXXX beginning the next April the days. noted be question-and-answer archived XX, remarks operator, call on the be As will

on During to statements be such this statements and projections events. Exchange making and statements believes results call, current and can forth with management a will those set based similar periodic risks can expects, the and forward-looking may as the regarding about materially expectations be Securities such forward-looking number statements other including Generally, guaranteed terminologies of and in forward-looking Celsion’s These statements. uncertainties, or company’s expectations filings from actual by differ No are Commission. anticipates, be identified subject expressions. future are

I update of date obligation call, the of call broadcast, this also by undertakes live Celsion XX, except comments or law. the made March required XXXX. during to of as only accurate revise caution no that is content as conference this

CEO Celsion’s With Michael? that said, I’d like call over and President. Chairman, to Michael Tardugno, turn to the

Michael Tardugno

you, everyone. Kim, Thank and morning, good

and Chief and are Anwer, Vice the our of and on a Officer Chief Executive Dr. Joining the minutes. Celsion’s in our home results Dr. Chief Financial Science who our for me financial few will call from Borys, today Jeff is Officer. Khursheed a Medical Q&A recent President Officer, Nicholas provide review Church, working Also

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and phone the a We conference normal system. are calls conference investor into are also on dialed

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understand can some participate. reluctance you to So

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are due small Dr. nonetheless." findings significant statistically they are these you, to numbers, Although, Thank the impressive not Borys.

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we second of of approaching will analyses after This as interim fast two milestone efficacy deaths. a is the XXX take Importantly preplanned place minimum said.

and favorably and to to in were X.XX and X.XX prospective for ratio is value value observed success subgroup the X.XXX at X.XX compares XXX value p Relative XXX deaths ratio hazard from and the p respectively. patients this p and ratio hazard

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second the with what success bar upcoming much at for Study three the for lower of For observed bar the analyses in that's a X.X than the upcoming hazard that we years. The success ratio = carefully X.XX. subgroup the analyses, clear. HEAT p second hope we is interim interim for followed prospective is I

you like from you in just Okay has impact let and now we've questions this I no of know we note just by and COVID-XX want had the a operations. to pandemic. I'd some as give about update you to impact start quick me many study our material sites maybe saying - The the China. anticipate

We have followed watch. closely careful under Borys' very Dr.

The years coronavirus had have period few Those limited open monitoring for followup monitoring a that. know restricted for has and of study for hospitals short sorry we two the followup. had now We the of impact being patients any visit of upcoming delayed now to compromised analysis. population are of on may the the a who delayed do hospitals expect for in we handful time. data the Few anticipate that followup not into any now for the are now they anticipating with, We are being that, interim scheduled. for about way scheduled study be visit are

know imagine for imagine, situation I that We'll so, Second, our enrollment impacted, limiting Timing cannot patient or impact, the say are don’t if sites a OVATION X in study the is for I Phase the but we X this I'd trials. it cannot posted be of U.S. new be be startup you because develops. as month keep the may may reemphasize trial more would sure, for two. than for

about early like briefly in both we to the manufacturing and have I'd put talk to in redundancies I In letter addressed ThermoDox stockholders March my GEN-X. for issued manufacturing place. smartly and Now that

our cap-ons cost. supply Our a manufacturing very can at attractive partners China lead [ph] in

With States access raised United position financially this better the the new redundant and capital U.S. that we're a European capability we in to in from a suppliers.

requirements from confident note these that well for with clinical as and supply than the some chose years TheraPlas clinical result [indiscernible] manageable, our GEN-X. as as supply. So and do suppliers for they our a our for source to worked I on research to COVID-XX the use our Chinese polymer Chinese capability the I impact for has commercial supporting are had are supply want we GEN-X U.S. that of backup rather in for rely and requirements very ThermoDox manageable supplier,

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with primary advantage the There ThermoDox. to are The of purpose we numerous starting to that incentives commercialize incentives. available subsidiaries be financial therapy innovative from and made subsidiary to the the Chinese intend take will cancer those Government is financial of

China, ThermoDox all of subsidiary vision markets, developing Philippines, all on to and including the economically local developing Registration to markets dots the an focus the we a expect to so. addition the next In is or Thailand chart nearby nearby on manufacturing subsidiary be the permit structure. provide Vietnam-our will operational Malaysia, focus including will partner virtually cost within expected subsidiary month is the it of viable complete,

ThermoDox for NDA/MAA begun the have in we And writing HCC.

in Our no have of the it prepared the Study. to more goal months OPTIMA officially unblinding complete is to six filing than

company for over review Before that is to I success. well XXXX I our turn emphasize Jeff Church the call to positioned financials want to the

nothing will trials transformational our the be If next the and importantly our short and our are our and company, doctors most for patients fundamentals employees we're remarkable. shareholders, our of from months research Our the evidence solid XX supporting who the are and right, endorsements clinical and products. benefit

the call turn Jeff. I'll Now to over

Jeffrey Church

Details filed XX-K Thank which in Celsion’s press XXXX our we included you, and in we after of market full results were Mike. issued the evening financial night closed. the yesterday release last year

stated, during made progress products. lead significant XXXX developing As we in Mike our

goods management, We to cost our continue our and achieve all deluded opportunistic and position strategy efficient to of which attention supply execute our of on focus careful goals. cash our financings and to us minimally and chain,

Celsion’s the tax an As million. investments million registered of year-end deferred cash, the net equities including priced to of cash $X assets we raised additional December sale XX, proceeds a in million of of totaled and Subsequent XXXX February. from $XX.X from direct offering $X.X end proceeds at

potential strengthened against we our erosion opportunistically market As buffer Mike of the uncertainty. sheet continued to share face earlier, in indicated balance price the for of our

operating quarter of million New the expect deferred net losses benefit sale tax our from XXXX. second $X.X in receive We Jersey to the of the

We New we transfer program future in tax Jersey million that year. to tax expect monetize $X the additional under this have benefits an remaining later certificate

sales current our New cash planned NOLs will of our way plus run operating Our extend Jersey mid-XXXX. future into

beyond well the occur the of quarter during OPTIMA the XXXX. of first Study is this Importantly, which final likely readout would data

Capitalization an common and have shares current funding price. on XX million we shares future to above shelf exercise time. sell stock warrants statement appropriate X.X to only market which have XX.X million the price registration a respect file of the at SEC with table includes million our flexibility, registered With

$XX over that million remaining We have under registration.

with and money company. the allows under facility opportunistic use that have fee. us raise of a also the commission after traditional of no Trading at market is control Jones ATM to We warrants a very fashion, complete an the The facility low of with

Turning XXXX financial now our to results.

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of were one-time OPTIMA decrease completion study to resulted This credit, the is the lower XXXX. for in million during in the Excluding OPTIMA of trial. phase the million $X.X fees over August this primarily development enrollment due was XXXX. study of which $X.X clinical XX% the costs CRO XXXX, in followup of decrease This monthly a

associated continues to with during XXXX. to program registration ThermoDox XXXX, $X.X $X.X the the manufacturing OPTIMA to outcome year. million batches million with the $XXX,XXX costs As organizations production we the in of in of compares costs ThermoDox prior completed were $X.X in contract amount compared in at preparation related activities This XXXX regulatory NDA our successful as advance, encourage Costs assuming regulatory the million study. of we at

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in payments XXXX lower in due to for compared prior to GEN-X issuance administrative the was million $X.X related ovarian $X.X Other net General year. in the million amendment compared for This a the of potential million $X.X cancer the to candidate. of a were XXXX. decrease and $X.X expenses charge compensation gain expenses to stock non-operating XXXX of product year $XXX,XXX current primarily warrants an the expenses million for non-cash milestone included for

milestone offset the XXXX a to to of product in-process certain non-cash of This research $X.X development compares in year. company for charge glioblastoma million impairment a by the $X.X to company's of related compared to cancer income million The liability program. interest candidate in and payments prior related realized the assets million related $X.X in in XXXX $XXX,XXX with reduction same earn-out the

in of expense million $X.X In we entered with which of $XXX,XXX debt incurred interest XXXX, XXXX. facility in connection venture with compared June Horizon, in into we to XXXX our

losses. the During the tax benefit Jersey of company a our year, New fourth sale of income quarter recognized resulting the the from million current operating net $X.X

Net to During under the has fourth New compares $X the $XX.X million Jersey years of were The remaining $XX.X for company year. the tax prior quarter moving activities significant XXXX. recognized million that income we million a from of to approximately into used the the benefit resulting program XXXX XXXX, our operating in cumulative cash sale XXXX NOLs $X in XXXX. tax for million

NOLs in raised utilization while Cash in received not delay million proceeds caused and cash being resulting we NOLs the in them cash expect in from Total were $XX.X the included pandemic an second XXXX. and the COVID-XX million of activities, year's received that our first to quarter XXXX program this sale XXXX a million the of they provided of by have $X was additional during $X.X XXXX. quarter the approximately financing in

course cash line than We the $X.X XXXX calls the year annual usage will of cash utilization expenses on million. XXXX over quarter of our keeping for anticipate first our less with in approximately in quarter the that This which XXXX. average for $X be million is budget, per operating

call I'd the to to turn Mike. now like back

Michael Tardugno

you, that soon can to that important this the that OPTIMA two potential showing clinical having continues progress And hope to significant cancer. make now. I analyses Thank to Jeff. second analyses, both great of ovarian interim GEN-X is great a see forward very study I'm some a immunotherapy with of potential very successful. in interim in looking programs be Celsion our you

patient and more patients put just even and of data first. in I'll that by continue dedication I'm confidence been sharing we've we in our been of see as social Our saying, cancer. clinical ovarian proud GEN-X the I And distancing. proud we can not forward as the research always with have employees continuing, time last of accelerating if and in they to this of health our been from Celsion is months our close not to over number look you misplaced,

will So questions. with line that operator, open the I remarks we finished prepared by for and my

Operator

and first Company. with Oppenheimer Instructions] question you. take Thank our from Hartaj Singh [Operator We'll

Michael Tardugno

morning Hartaj. Good

Hartaj Singh

the Jeff, I have to and the GEN-X voice. seems couple a to to was, along. rate RX you stay on in is is, and I so in hear published. comparing I higher the your thing PFS thoughts It's overall was that Mike, wondering good on good how One keeps One project of going data just see the questions. you're Hey started when to Great, lower your you moving it sorry these resections. in – an any are increase doses response these ORR patients patient response just dose patients seems doses, But the numbers, small have know these to but there? same.

Michael Tardugno

Yes, do that But like but new was I chemotherapy these Borys. Nick? that for think be don't to unexpected, chemotherapy question to we adjuvant to expect this the I'd turn the patients over effective. Dr. really

Nicholas Borys

we've I Hi if your rate understand peak for already a wondering correctly, in doses. terms our Hartaj, response question different reached of the if you're

Hartaj Singh

when you XX you just the patients the you RX I of RX meant the because doses translate is, No you're into the lower its it guess definitely your at and the say was better patients end ORR, – higher better I in Shouldn't you the XX%. look approximately resection. expected section what XX and show ORRs doses two a getting be different, to

just So, there versus getting what the GEN-X the GEN-X ORR the And chemo was was with between I'm in alone the was what chemo? at XX% then that plus [indiscernible]? that's group guess combination the I a the for difference was that the ORR or

Nicholas Borys

actually immunotherapy what bit But looking a at an rate. and we’re result as yes be RX do in you seeing the that the what not remember little radiology we’re we with in could numbers mean I is the ORR notice see the what with deceiving question I with maybe patient. small Yes to and consistent the immunotherapy think that is that a interesting and

long-term more bit it’s and the moving go the and the at might a immunotherapy PFS ORR be taking towards of looking way little So rate for grain for the because salt best us. to RXs the looking at data with

Hartaj Singh

chemotherapy similar I maybe or for know is is less? a timeframe ask it ORR the question that it a Yes do in is which historical so understood what slightly I guess way XX% different if is the you

Nicholas Borys

top to think have to on to you historically. I'll see it's But back of that. the head, do I get we similar about my what off

Hartaj Singh

impressive. thoughts in so higher be small then the it Okay. very the there seems separating numbers, hazard not reason is I out And the and on impressive, the of, Is ratio are still why values look value? ratios But still know different Medidata there doses mean any on a there like, any and again, I to hazard the dispersion it p yet they're side. broad kind p analysis, got the you've comes fairly But seems are to there. when these

Nicholas Borys

with we're are XX people expect to to small are these questions of p what anything giving Yes, small numbers really from the are of very one too Medidata know we not that here that patients looking are value. to numbers terms us just because the think gave I Acorn would are strong is hazard XX us. trends. And P that's numbers, a the expect the or the these you be beginning significant. people values ratios right These certainly looking the in that And what we're for at

design, into we now XXX get over where we robust more results. I patients, see think we Phase study II could the have Once

Hartaj Singh

And [indiscernible]

Michael Tardugno

looked by have quite determined presentation I'd like we benefit to clinical that other When at hazard or as small large. kind ends the all pursued see add of similar the to ratio be to they companies a Hartaj. we breakthrough appears on who therapy a

with confidence. and treatment enough quite stated nor but So the effect, magnitude of to to statistical not be large, appears effect typically the

Hartaj Singh

again? Mike Now and that’s fair

Michael Tardugno

Not a issue.

Hartaj Singh

and Mike, that's fair actually fair showing some you I and might That's not. for again, laud Borys the companies P value

be throw off be which your that three months the second six was terms if the to ThermoDox, Just over to steps next any that, sort expecting we're you can in of it the plan? the The other COVID-XX just us in interim, let's call of next is what and of, the through steps? could walk next positive would scenario

Michael Tardugno

I with Yes, accelerated a we we let forward, insignificant, the in I associated impact see me plans NDA COVID not that the in don't start have would and by documentation answering – the our virus how prepping States United Europe have a time result. positive very the MAA the the second is going question for mean although trial assuming submissions the first, China, schedule.

I As common we're said and the for MAA the so technical same Europe the using writing NDA NDA prepared the at and document we've earlier in begun essentially comments, time. my writing approach, – a

very out So, the in next steps we've chart like a Gantt planned fashion. almost carefully,

they it's may are week on DMC them. to notice the some we the the we results us receiving be If discuss we let a know no have from holding the about an hold opportunity we simply we positive, that we’ll on mean, that unblind I are put comment results notice a and meeting, in them a a trial. that, we agencies that but mind. doubt have the we meeting our to positive agency before with DMC give And on call study there's that them will expect

would in no There's a a approved successful interim result analysis by that trial. ambiguity recognized here the positive have that agencies our trial regulatory all

We meeting, days about takes usually will they XX a schedule. then pre-NDA immediately to request

comments, with label – we Once have to we comments to have their them the fashion would the and course NDA. us all a scenarios like, the at trial point present from what once we the give time move then and forward. in a FDA clean we the dice look complete slice have trial format so we data of to and this give various proposing agency data confidence enough that to successful They'll results, the to of the

And we be time the more FDA. study. time it no more that input, that, the have than than that could to expect we six more I'm target depends on designation quite take but whole Fast that’s it to no we the Track six agency's the from from expect than months. We take hopeful unblind And U.S. that following our months less, but no –

Our face the Track Fast expect the with NMPA. ability in would provides review, us designation we to achieve to request to meeting which face with priority a

priority half application with CFDA. NMPA an six FDA had a to That's and they acronym a the a and the a face that a high review NDA for about In new meeting turnaround. Chinese commitment to the month the year Borys gave us ago, with Dr. face

into our So large their that's already have our them suppliers to producing materials three our advising forecast begin outlook expectation. of We're Immediately of our of could quantities be. inventory. of raw we high and we suppliers, gear what vendors, go

business regular if on would plants the second with a travel we’ll hadn’t our had year. have place to this some meeting in basis with of the plans, been we COVID-XX and interfere We've those them definitive production in half have expect

here in other the and that's There's on. some could staffing once most the additional we that we'd move for use Lawrenceville obviously, activity small a be Obviously, little part, commercial resources, lot So Huntsville plan. this up – group of goes that's forward.

your say opportunity And than in cabinet some who the I'll very are last There see just companies, for commercial one one and more taken a open you medicine interest serious could this pharma point. have ThermoDox. names

So sure their and be spending we'd company. time shareholders I'm for those potential some discussing the and opportunities

Hartaj Singh

the patients non long the know, squeezing with or the second to of money more period do just that thanks. just And last a that? Mike, idea How in X Great half, for company. long keeping as the the of a run idea. take OVATION in to will possible But an run? on sense for just Jeff how you with that long non-dilutive starting little into as a evaluation can number us give then You rough have you kind plus, just on enrollment expect kudos on, will you and XXX the actual how question

Michael Tardugno

call quarterly the was last more large little coronavirus just that's a it It's close and issue. than conference

know, have with with a study You dealing number of - patients. this nine are investigator of know, you an hospitals a and preparing for we number influx large of them, all initiated sites,

including their have in they're mean, ready I Canada, sites ready go. on More two to gas pedal to have they they go. have We foot also XX the and

we will of new start a hospitals a number issue start When we this not pandemic that go, them. trial trial a say until behind XXX not however, kovat know those will is

will and or our in US initiate what here's really that the one that you to those thinking patient the DSMB. trial But sites will two of expectation the want three It'll solid of bring get sites months. each guidance. been thumbs the we've every we it the up once enroll Canada. is it's the from hard approximately up So balance will XX give some

complete coded less. they're the and their be about enrollment distract do workload the of can expect that quality enrollment, then study added workload trial clinical in until timeframe to reluctance convinced But to doesn't or yourself that is phase sites study that by to it's as could expected the we clinical good from who a be We them to that of one, the able well Ask timeline are maybe the could XXX these patients XX it be recruited month initiate some study. influenced patients you XX math a

Hartaj Singh

I Great, the I appreciate thank Mike. answers. all you,

Michael Tardugno

you. you Thank much. Thank very

Operator

Matthew We'll with take Trading. Cross question from next Jones our

Michael Tardugno

Matt. morning Good

Matthew Cross

taking from on and I particularly guys, GEN-X. for morning. questions for guess me good Hey guys a progress the couple Thanks congrats

RX I up the what I dose. rate response about what – So glad the you're the high of patient saying earlier the on see in is historically. kind definitely numbers up as the suppose was like also us far low were hear dose? was mg trend picking bringing groups in look for things XXX I'm resections Hartaj dose for to ORR the And what

patients was milligram it like a the between dose-by-dose rate the little resection for dose basis. XX which in rate also first bit kind and looks at the and dose, at for the RX mg reported drill XXX% on that a XXX wanting RX the in Because I XX% guess the to is of you saw what dose. you XX nine XX% – But on

patient kind and a XXX effective into the so mg/m² far So most to that you two? just confidence see you've of one part indeed trying should doses what studied the that maybe two be missing taken of we're gives

the any little the to I related guess how a response that, to for driven And dose speculate PK/PD. you us of haven't XXX that's or follow-up can safety know you kind carry part going of two. conclusion about continue in trying escalation bit if so whether that you by reported dose and escalation, came there's And regimen dose I to ideal to kind dose, potential as some still confirm it’s just forward that exactly DLTs that? remind of thus to mg/m² in far establishing

Michael Tardugno

responses. want to the I then that hope try and you've I the RX Nick on question second of So first, answer got to dose all dependent

with maximum the Advisory XXX have a point meeting our that this think to that considering although Group discuss is it mg/m² any we're has just sure no. really are in and to I Medical the much plans increase there So of few are don't making the here weeks there's at dose what the further, trial – next steps next for the we with dose and do to

we The the make starting sure up meeting is about. interferences to study that are just with that talked no there

XXX practical or So, largely large with have the This is very been at for halt volume mg/m² DNA dose along high our a volume very a plans conclude escalation dose to escalation plasmids of reasons. fluent. with

mg/m² have [indiscernible]. exact if going to at XX, becomes So, believe medical just I a numbers I'm centers there so some more turn DLTs the that, But patients any and issue. need and with don't I than our practical this the issue, seen dose. the a Nick of with any XXX yes to Nick higher you XX are very over it we've DLTs breakdown

Nicholas Borys

Mike. you, Thank

patients consistently like be are getting data is control historical RX I other think in that from early the answer group getting we're OVATION are the to doses, X acting very that in we studies. controls. seeing study, the much are highest to that resections. a And seems where against our GEN-X good see the we seeing that And at rate, best the particularly question consistently the RX

tumor are of Again, the they indicator patients feel that resect it's them. to getting for are this out that GEN-X than positive to better interesting And is that the us. surgeons an reporting very the are the clean

encouraged data. very we're by so, this And

highest of consistent RX with comfortable mg/m² it's think the moving I we the feel doses dose. at and So numbers forward where the XXX

And to saying safety If we yes, hints what confirm higher you're go of then GEN-X very the probably Mike we We've reiterate earlier, no DLT. getting between had can dose, now. of and to just the all good. very, to, asking could that we're a a earlier data but was wanted what key drug looks of I the

RXs, II agencies how it our data, the matched the and Phase of, against at of totality safety compares this the certainly look further you looking looking well at it the have means with looking pursuing study. we at now further regulatory pursuing control arm, strong a this If signal at synthetic and in

here. So think looking I the some have at big picture, we data solid pretty

Michael Tardugno

question to numbers response you give to some in And your there.

of having then that two to patients patients the who five it and XX%. an is X So RX RX, mg three or XXX the at had an RX, have XX XX at dose it but dose is mg that's XX I five average believe patients is of dose mg XX, or and an X

Matthew Cross

a just the getting five I on the as and fronts, which you dose patients gave both little mg and no, think data that the far about the that dose, look I better smaller just Got the us with talked was both tweaking increasing as agree nine did on especially the versus five does so XX a it RX totally given group, out as great even RXs. And not numbers, – was for six of ORR the I bit maybe XXX maybe far. more but than

whether dose to like a saw XX whether considering or mg/m² more was made sense throwing you out dose speculating might similarly but if really XXX, there? ideas what just back that just of or perform patients bit a the kind thought you with going So those few about in any little that little

Michael Tardugno

We to these result at Borys, we just just with certainly medical tweak I'd any the mean, Yes, to have. dose tweaking our on I – and me Dr. rely advisors – on but than to say we was arrive small to might seem not numbers. going I better attempting have currently

Matthew Cross

OVATION was the one about bit we're and kind Sure, that X extrapolate guess compared from are released trying I what guess now PFS to I I absolutely little just a from results. last mPFS me you understood. one then to looking control ahead today, arm. of to synthetic seeing And was

for see that to you've a primary PFS so stayed OVATION two the endpoints? you part the in ratio see aiming that to you're X XX% that So for improvement need of hazard required

confirm on the if hazard And be X.XX a to Medidata, would I whether all, regarding way the hazard any FDA adjusted data synthetic designation looking would for success? just tweak and with if breakthrough potential to in discussions that the this you'd translate And ratio arm for wanted would be to ratio. whether based control that modifications at

Michael Tardugno

And what the improvement. change to of with first just and I XX% address interpreting at number the liberties, had essentially we've a a so I some on I going we trial. really point, if lower ratios significance hazard liberties value, a I But when we some but is your am successful P layman to than mean take rely – I the course, what say

of get mean hazard occasionally that is of hazard for I and t a by to sometimes translation understand. is ratio X.XX scolded although liberal easier liberal But Borys other people translation for I XX% a me Dr. ratio. XX% a it's is

if Nick, that? have So you want anything add you to to

Nicholas Borys

a just the And data that's on Mike. think question. ago. synthetic We I the saw days thanks just control great Yes, a arm few

digesting still we're So it.

to had our you is data because be think adjustments study some there points. arm question this exciting think the great some will and made that maybe. I I from control would be number, so say is I with So going there where you're synthetic Will – maybe

discussions with reporting you And assumptions. on of have II I they the it's label. Phase keep synthetic because how also be know And as the impact just of – feel the would on channel, to data the have watching on our we'll FDA. our quite say, this because hope open we'll See is we regularly data findings

forward might data. look to because authorities. with And adjustments there we of some so, this be discussions And regulatory exciting

Michael Tardugno

with is also Yes as in meeting designation. like agency prepared review – no encouraged I'd a we to intention, follow one it is twofold I that to would do the I I as our remarks, compelling. mentioned that. a is, may about result add the get is really to second data goal these a is this my in up for have have that a us – do I in is how they one add conceivably Phase of earlier on thoughts qualify study. program of a to discussion think positive mean, we assuming on that and our I’ll we Breakthrough the like can where do designation to this asked the this to reduce to time it quite how and you of hope But have that area and that could is we question part we data do is, number we accelerate II The

Matthew Cross

they it And see guys. I the appreciate regulators and of all Hopefully no, as Got the that with input. I the Thanks, all for best those hope think do. discussions. I positively data we as

Michael Tardugno

I go to you just question, I the know And next all before right.

using And treatment novel So It's have effect we’re good a ground. some territory a like long that have taken territory in basis as time. we’ll I exciting very not a of given for new innovation discussion. it's to think discuss productive we I break the – here – the agencies here, recently, so in we compare discussed pretty opportunity control think a posture But very the among who synthetic new arm theoreticians been very something to trials. GEN-X expect that clinical the a

So yes, can go to the operator next question. we on

Operator

James. Dawson our next with Kolbert from take We'll question Jason

Jason Kolbert

hour, know the first just versus deaths this keep to it’s wanted almost go second. XXX I'll I the saw brief. so Hi, XXX guys interim an I you the on through that versus

Thanks. data? I pin So to really that of when we're can down going the timing see

Michael Tardugno

reaching of for analysis are we so case. the interim Yes, on the second the threshold cusp

author treating attempting, evaluating of one firm and we the is two cancers regarded clinical is other one our Barcelona Barcelona DMC in Professor meeting, Llovet. the one I’d not In that's had say – because clinic but liver in of researcher in and we in the patients for members special DMC the are U.S. Barcelona cancer well, other liver He's Toronto. highly criteria are fact residents

been has dealing Nick So with schedules. their

answer July, of this And successful to expect enough have but meeting I's that events we expect so, to all the start point. confident have got a I very to cross meeting T's your we that frankly the the all am have Did week that's put the around we'll at when we and it. hold DMC all question? and first to

Operator

our from with We'll Capital Instructions] Markets. next Raja Kumaraguru take Brookline [Operator question

Kumaraguru Raja

the think reduction GEN-X and control OVATION regard think there Good further patients going further in taking in treated in to you a FDA? to this the explore for X the some control communicating more to would be is there will timeline with with thanks of you or What trial, I of impact would data. morning, question. how it terms patient there? do the terms include control like is synthetic do my And the to synthetic possibility be expected

Michael Tardugno

is me many a of within here let Yes, the first set the that a That question, we discussion. discussing so a the I group has for breakthrough committee agency. screening answer requesting up timing protocol would met agency There's committee. designation, with – your this first screening bit our – the companies with

data I provide document, think we’re we request and relatively document, to document. within to right our XX small response as Kumar, and them all soon a days white to here, with to just once digested get submitted top request to going agency We're to go of receiving just expect paper them them have our away head, white but of its request the this small and my as from paper we have possible. work provide with together the put the we've

wouldn't but I weeks. couple a guess you than more an give be can't date, exact would I it of

we to for if to a strategies that about of we for trial response it, numerous is as a I we receives agency that the is. clock start were breakthrough accelerating now So opportunity us benefits mean probably designation. variety a that the six There to That given accrue company would the see the weeks. are the discuss from expect

includes and foremost associated research not the only list, overhead, treating clinical the I also us patients. mean, with for direct costs but first conducting on our

course, better get off So the timeline the of for the results community, for the we medical shorter company, financially sooner.

So objective. the be this timeline be of of agreement include Apart from arm. our that able control patients can that part FDA ability to a would that's as shorten our to an synthetic we database

synthetic have arm not a control, that of to arm only if recruit patients half split, it would into of would which we'd patients the other be be the you would the would I control all for the patients, one think one XX/XX organically the are of we’re think goal wise don't control. replace organically recruited. a the about it we've on talked we half control We've would talked a internally, about be control

Give the for looking coming us truth. some are are the that results We're that not true. confidence we're seeing

that's is this the So to one a cost timeline. way for virtual less treated than for reduce and every that organically would time is cost the our the obviously And and patient – cost. recruited patient. And a an

one be encouraging discussing we very many announced objectives would of of today. that So result this that our in

Kumaraguru Raja

thanks. Okay,

Michael Tardugno

you. Thank

Operator

no the in we questions have And queue this at more time.

Michael Tardugno

do we for it. questions. a thanks I our all guidance. to little and along. we've really been Phase seeing some appreciate Thank clarified but hope all well, over to I Okay worthwhile. data was excited is our question. you without unambiguous. we've it some bit, I study, your We think We're concerns analysts we've think ran added additional the GEN-X and with what We The the program very can say generated additional validation from Along is first Ib now our that provided translation

in control with to elements of are dependent and in chain But and to dose the that been immune recruited about so that. the pro-immune. the mechanism benefits. system tumor they comparison become in And They a have for now, arm, – confident. the to been to some the that analysis, clinical we support concern support doubt virtually there's GEN-X There's of seem all the no to an immune now synthetic some the works microenvironment all the way improvement modify extremely the system

this forward investment as the with in the program and we we're the to think being be a for presenting digest our it to that for year excited we development detail said we breakthrough We company. could more extraordinary agency an reviewing is this That year it are and and community it. are looking

maturity us cancer. early suggests our and patients the the for with As blockbuster July every chance analysis, I primary successful of interim for study second very the that in therapeutic threshold have said, of success we a suggests on for we're the us being liver to to planning

forward all please that thank in have, of a that said, I kind the difficult patients personal prospects difference stay lives cancer as you our make work another. safe one All time area. and that huge and much, everybody to to look being this tell we of be On note, I in we very the a can in want period

will conclude that So our operator. call

Operator

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

disconnect. You may now

Imunon (IMNN) 26 Mar 202019 Q4 Earnings call transcript