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Celsion (CLSN)

Participants
Kim Golodetz IR, LHA Investor Relations
Michael Tardugno Chairman, President and Chief Executive Officer
Jeffrey Church Senior Vice President and Chief Financial Officer
Nicholas Borys Chief Medical Officer
Justin Kim Oppenheimer
Raj Kumar Brookline Capital Markets
Call transcript
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Operator

Good morning. My name is Cassidy and I will be your operator today. At this time, I would like to welcome you all to Celsion’s 2020 Second Quarter 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 turn time, to call like Golodetz. Kim would this the to over At ahead. go Please

Kim Golodetz

second and you, with Corporation’s discuss to Golodetz everyone. LHA. Celsion financial its to call Thank conference morning, Welcome good This XXXX results. quarter is Kim

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

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

Michael Tardugno

Kim, you, with my Thank you morning, good It's to pleasure speak particularly always now. everyone.

today I'm me newly of months II Financial schedule July, from that lead we Phase the ahead completed ovarian now recruiting successfully futility with a Having like in deal run being Jeffrey the suggesting to held a who evaluated gene-mediated and cancer. and results focused Dr. a as Phase patients Phase Executive and the minutes. touch a the Q&A news Vice advanced Celsion’s DMC has Nicholas Also some provide treatment is this second cancer. regarding who X of we've review on five of in of news and Medical this Chief programs, during later pleased Chief is We quarter diagnosed our second in President immunotherapy we the I'd for OVATION or But I Officer, with positive carcinoma it call. call we brief of financial III development fully conference Study. report pre-planned great with Because Study results, this will we for comments analysis address focus announced and our GEN-X, recent a is remotely study reported liver Church, OPTIMA primary Executive the dialing earlier II Joining much to on of that diagnosed efficacy that analysis, OPTIMA the and I'll now interim in are OVATION been trial year. X few Our a ThermoDox, of Borys, Vice recent President in, our on first, the Officer. our entered unexpected in on of known portion of our spate Phase to also have the the in both weeks initiated hepatocellular call newly where recently for announced the the

for XX sites being imminently We XX few five activated active, X XXX of with or recruitment the approximately XX over months. over the investigator plans an patients completing and active program aggressive currently OVATION Our next months more include enrollment next anticipate so.

synthetic patients strongly propensity a well beyond patients as randomized cancer the approach the from that's XX% This other control control enrollment. costs Additionally, control to of value, the time. synthetic are arm, we reduce however, replacing of will goes trial population arm The studies. using of considering control cost and match about novel ovarian as time complete arm XX

into As the receive joining patients to are most concerning many for who is study of recruiting the the trial you order randomized drug. part, investigational for in a know, patients,

Now XX-XX be chance outcome, a with patients can disappointed. of the this only arm in the quite control

X trial, review a this of X, to OVATION powered Now for the OVATION and XX% improvement you progression-free is is randomized study, arm I'd two primary to survival. new a its like to X-to-X Celsion. is in who are show endpoint. XX% particularly those PFS

being label you study. conducted as an know open it's As

as study So scores. prognostics the rates endpoints for of throughout to surgical and overall to treatment. in course are are become we be recessed the will and the able survival. These Both according updates both include resections response provide they clinical updates overall will available secondary

are size compared to trial control the patients dry cancer off, that too dry great pretty be shrink tumors and GEN-X care chemotherapy them neoadjuvant to up, of deal burden will chemotherapy related Neoadjuvant whose alone. tumors good surgically all is coming standard them as Neoadjuvant a of no for effect immediately The margins. to the disease all found among these or great Treatment removed are improve is with arm advanced is is That for removal a patients, real combined with progresses. a To with fluid. disease chemotherapy being here be the designed RX complete just to related neoadjuvant outcome. disease, idea an complications. arm surgical calls be the is And goal surgical of virtually to So the chemotherapy. the GEN-X's the current design goal treatment study with resection. in a have of of for we'll

Following this will weekly adjuvant the has surgery, cycles of treatments, arm. to nine cycles the and of been debulking GEN-X randomized three patient patient treatment undergo to up if the chemotherapy

Our progression Result this that's prognosis. Because overall clearly to expectation. treatment in goal level over high progression, of GEN-X a with regimen a six activity is period. system delay know poor our immune we that portends recruit month a a being

provides transfect vectors with of non-viral mechanism. value. cells coded -- our plasmids, to TheraPlas proprietary for again, like is system I'd for who delivery traditionally new, proteins technology to of that GEN-X platform. may a are TheraPlas DNA delivering is a gene engineered for therapeutic Now, plasmid. GEN-X its using those those be and means you review used DNA nanoparticle Unlike viral technology

not So TheraPlas patient's activity unlike viral be of to system. administered immune vectors, is the subject that neutralizing once, can only

the for it administered technology required typically is immunotherapy. again, and beauty and making So ideal vectors for of The over treatments are results. does this it cancer the can titrating carry not multiple be of that, effective viral risk treatments over and of course particularly

the DNA cytokine local a platform The body first such plasmid this administered the TheraPlas of activity protein systemic cavity as is for into IL-XX. interleukin confined and why widespread not recombinant advanced be is toxicity or ovarian drug or toxicity use is for IL-XX GEN-X Systemic cancer coded with pro-inflammatory use. administered avoids the is regional the regionally incorporates GEN-X. IL-XX. abdomen reason the the treatment. associated local GEN-X on Its intravenously, XX cannot

of provides Huntsville, in our by research scientists invented IL-XX's Alabama tumor the any by improved significantly in the mitigating our approach site toxicities. an in center while solution that Our elegant activity

a Rosenberg. So make up one It one is accomplished cancer secretion last system recognized was following I'll administration, our by just powerful recognized was It old means recruiting a and solution Laboratory Dr. the provide to GEN-X in very of at cell durable, a potent effective the well-known the to safe, has note amazing the about It is was transflection immune a robust local, IL-XX then of it first fight response, an week. in potential resulting effective therapeutic. NIH safety for XXXXs to immune malignancy. as be to decades persistent, IL-XX. to problem. Steven modulator

patients months and admit, so and is of during limiting far treated that numbers, toxicities dose can period. during weekly why proceeding the quarter, final XXX in announced stand we second milligrams unanimously we squared. that small on DSMB were no profile per we satisfactory have do results programming, this a meter six to XX its but Phase during of are detected that been supported up nonetheless. of concluded to based a with higher II safety where So so I'll course recommendation doses impressive The about encouraged the be dose treatment DSMB with a GEN-X’s with

a Let patients numbers, population And treated or that We of the pull arm spoke chemotherapy XXX the GEN-Xand with match treated XX dependent OVATION inclusion talked alone. at surgical microscopic GEN-Xwith portion approach were of approaching propensity me resections of taking similar nine And and we Phase as statistical I and quarterly I, data progression. XX% the remains of give arm neoadjuvant neoadjuvant is arm control that account Though which the negative three a two having improvement you data. earlier studies, done of RX small we treated of an XX six in plus synthetic patients dose arm comparison significant a of efficacy findings of control prior significant margins. out margin, just of up. reported or progression-free the statistically hazard when in RX of significance had patients in the resection This with these again, X favorably translational about the numbers ratio survival all same GEN-X tumors, per nine in results X patients it successful were resection, May. to edge In criteria a the chemotherapy treatment published call milligrams I compared from example studies. X.XX no were but patients Study provide to XX% Small six can gross into score which impressive in a particularly resection. during seven in had the when or I, compares while our time doubling meter we combining the the previously indicates, squared, OVATION with when or the an in support I earlier to and not of our Phase chemotherapy. study tumor or to that with from suggest Phase said control Study a a synthetic new When dose reinforced patients microscopically the these

responses. that samples Phase demonstrate tumor study clinical I is from profoundly our So showing from clearly GEN-X active other tissue taken Phase in dose our experiences I prior data dependent

could we control we what to that see can have to on building conclude would noted you asset GEN-X show by Phase are compelling the continue from synthetic basis think is a a forward very be, comparison foundation to promising suggest in conclude for I'd our I'd early that II what I be worldwide. efficacy trial. and work, very saying the arm Should which we GEN-X like that being to. is to much look important launch

exclusivity Drug Finally, of from Orphan seven XX the particular Medicines from Designation exclusivity. enhances Drug year a years market this I'll also earlier market the value for course the States provides provides GEN-X, note United the similarly approval. Designation European and the which received years NDA Orphan that both Agency, In USFDA we EU received of following have in Orphan Designation

well-positioned turn outcome just we financials that steps call want during to before said ensure what the our the reassure our I taking the and I of Study. regardless about recent that we reiterate are is the appropriate OPTIMA you to of company So ThermoDox,

are million expenses, $X I million months As And expect begun over next budgets. $X we to non-essential some said, all -- save to headcount XX the eliminate including unfortunately, versus have our some we reductions. ThermoDox to

the it Phase Our plans as enrollment progresses. will to OVATION to this II ensure reporting We're sufficient on capital that Study. forward have complete we study periodically of looking

for But This the recommendation that Monitoring the X.XXX. still company, recommended study a is decision into following futility, the is primary to for analysis. like Study OPTIMA the an value the interim we're of treatment stopping trial that advisors. it. X safety I'd on analysis us. cancer. up the We stopping crossed the should of X.XXX. and Data our The work turn for with left they the was that picture do working to made is complete boundary our but efficacy not consider we of independent DMC's liver pre-planned going the Phase that second the to have but pre-specified reported company formulation for actual of futility the a In ThermoDox, Remember heat-sensitive Now, the was lot liposomal July, boundary Committee found on DMC's at doxorubicin boundary ThermoDox

essentially provides for value. the the this study -- Therefore, a a the of final hazard and ratio the as However uncertainty high for analysis, p might value the of of decision in actual to unprecedented I level stop X.XXX, left say unusual an up whether to DMC to an flip coin of step company. the

As we've DMC's that been recommendation, hindsight, the is in wisdom still some to to data, say yet jury appears reviewing the there the know out. but I'd you be

may It noted the futility cohort the patients analysis, data disclosing in patient maturity. that following the XX to consecutive analysis, overall the When deaths treatment patients to interim arm and additional analysis for we associated suggested provided issue, interim represented similar second may exclusively of in XXth far which for Moreover, point. than eight further deaths remember of differently XX review died comparable survival, before we deaths. reversing associated treatments recently balance occurred is also unblinded deaths date. there Our compared X-to-X completely exclusively is interim we the behave a unexpected the Study’s the XX treatment the this XXXX. the more second after data patients -- arm marginally overall maturity the to of in the crossed The reported ongoing trend of seen by follow -- interim patients the arm OPTIMA the favorable upon we the number approximate the who to from HEAT an in update and have second based, XXXX remove between was pattern of be Kaplan-Meier that Well concern Study deaths arms Study consecutive our supports data the as suggests September ratio treatments continue data noting analysis, second consecutive the the compared survival and as control at prospect subgroup the analysis tests be with with is that in the time from them maturity. the March as analysis, doubled, controllers which a were for of data of the boundary OPTIMA that will outcome we was and

over curves The of with OPTIMA at XX respectively, in all, subgroup The both Study curve, benefit, a Vietnam the issue, particular improvement XX% XX little deaths at arm months this sites point, statisticians compared Kaplan-Meier hazard the in control of and arm, showing time other the treatment amount. joined look after times of are a the were show insignificant to we But that initiated. regions. this marginal trial, me in over would we the yet times was potential see the probably also is geographies the months and we Vietnam, ratio control and eight this. improvement arm similarly in China for in of when Study the if patients death an of OPTIMA hazard death. a to treatment The in negative not in With about the testing at at sites behavior When that Study calculates X.XXX control in an XX% the sites over improvement of study note arm, death. a Kaplan-Meier median the where enrolled maturity which China XXX XX% HEAT the So, now on I arm ratio a Kaplan-Meier demonstrated trial the median given X.XXX. the the site at approximately lesser and it, give of

be but can Now, that follow-up, direction. we we study's be has reconciled, this the believe to done probably dichotomy must most with before longer determine so

survival. and Study we related we're analyses Kaplan-Meier data And National CT trials all it While the -- independently about will that HEAT we of but so of a being any do, that I their prepared, caution finally, trial specifically you clinical you including including in study I trends overall you you At can experts we these data, are projections, progression-free OPTIMA transparent I you definitely, be the tell tests sent independent however, between survival may to the assure insights discontinue are little to issues analysis, for plan to bit time, to NIH I'm CMC Health tell I point, and scans of statistical the mentioned. Institutes evaluate the that the our importantly, definitely, that takes choose definitely sensitivity follow-up it, that have I we provide sorry, at observations depending can just period, on during the engaging very can't can't I what all noted we conducting proportionality this may looking clinical for plans. tell time. for

our course Study with demand have we in review And we not the said from second press futility. August faced predicted allowed world may outcome monitor be, results and continue investigators analysis it. is event as other around trial the that as to see interim release, I may Unfortunately, our of substantially clinical research ongoing support we carefully to in unlikely clinical it regulatory beneficial while OPTIMA the XX as the be conducted. our As by change. be that may said, patients, options and the Xth I we with agencies the will FDA advisors The

unmet medical can that OVATION sure is I continue strong. population, large needs turn to prognosis. fundamentals both Study and X that Just poor this want say to to directed Celsion’s be before Jeff to be patient over we a

our utmost redundancy, built strategy programs development manufacturing care. is been with has continue with the execute solid, to Our

be States encouraging. outside and and both Our relationship to with regulatory continue agencies, exemplary United the in

with management spending sufficient With cash expect have over and deliver Jeff. it on Jeff? to our I'll comments, promises. smart turn We and those cash to

Jeffrey Church

second results of the were financial Form included in morning XX-Q issued which XXXX you, opened. this market quarter Thank we we before release Michael. filed the today Details and in Celsion’s press our

cash we Jersey XXXX, that and unused As will short $X from million, were unused of of the losses, New to million cash in half of of or Jersey Celsion’s fully cash XX, basis. of And the quarter June operations We resources operating million proceeds term anticipate investments NOLs New additional net sale sufficient our $X.X an capital $XX.X includes NOLs. which have Bottom-line, this year. believe non-dilutive fund our will our XXXX. we sold second be on the increase a further this of fourth reserves into net

evaluating operating We currently or facility our outlook. cash venture all retiring the will restructuring including debt our impact of This a projected portion loan. with Horizon, not are

respect During the cash XXXX, period, we This XX.X% decrease. compares net activities to $XX.X With used $X.X remaining. comparable of were the million registration with shelf second prior future for $XX operating the million quarter $XX funding million with year on SEC to statement million. in have a flexibility, a file

facility low to very and have a that no commission. money at after-market a JonesTrading with us warrants traditional with also raise opportunistically We allows

million compares Research of now to a Turning $X.X share our net $X.X expenses, This Celsion expenses $X.X year per were million XXXX. $X.XX quarter. a June $X.XX ago. June of current million million for non-cash per ended the or for XX, million share. second million $X.X quarter down Operating reported compared to quarter the a quarter and development to ended or to year loss were last including $X $X.X XX% P&L, expenses the loss XX, in XXXX, from

Study completion for in second was this continuing by quarter and $XXX,XXX the of associated in modestly General for expenses down value. revised X to supplies approximately million II $X.X $XXX,XXX second of second further enrollment milestone ovarian for Study XXXX. to that to $XXX,XXX building valuation increased change will for liability support this quarter, product in the in a And company was our interest Costs needed the August this Other cash the we non-cash quarter costs was XX% ovarian shareholder XXXX. incurred Our In charge in related believe the the with provide of included period of $X.X year current earn-out The costs year. the progress in with of $X.X Phase be and candidate. supplies X both to OVATION costs to of year for the increased same plans, are OVATION to million $X.X call minimal expense opportunities professional portion this quarter period of during the for compares last same GEN-X decrease year $XXX,XXX of And at year. periodically The our clinical administrative Study. venture and patients for is prior closing, spending for be with regulatory behind to expenses late period. lower additional of to clinical keeping year in were with a largely that the utilization the compares Study, reported from the XXXX cost due trial, quarter in facility full driven and third in aligned follow approximately $X.X OPTIMA net that anticipate patient with to $XX a us. ThermoDox the our in comparable We Phase $XXX,XXX in this the GEN-X last OPTIMA usage are with from primarily for III compared debt of $X.X second cash data the stage in cancer our this programs were the operating which the that connection Horizon, about $XXX,XXX the XXXX. million will for million year, the million the for the this attributable planned of the million fees. largely clinical ago. manufacturing expenses to year our Other This GEN-X million quarter of development

to Michael. turn back to the call Now, I'd like

Michael Tardugno

Thank you, Jeff.

financials. very of our We As summary a always, appreciate good that.

questions. the operator, So we'd open for like now call to

Operator

Instructions]. [Operator

Our Oppenheimer Company. Justin comes & first from of question Kim

Justin Kim

through the manufacturing improvements to the on plans question refine us and walk I any Could process process? made you just the just a further to future had GEN-X.

Michael Tardugno

our sophisticated investigational -- GEN-X, now manufacturing all Particularly -- That's question, We those quite contract including good Justin. a these redundancy. all along that for are of of particularly products include many by strategy consolidated organizations, about a you our since environment, creating manufacturing the facilities are course, parental oligopoly. someone of have like venture always and the and worry injectable price. supply being that to as capitalists, drug And, acquired in

the And So aggressively, plasmid with doing been we've we're are a result plasma. taken tell the by the about the Chinese-based manufacturing polymer competitive of States has almost to in initiative, and of of of earlier, the can components an confidence in plasmid. the factor the work talked magnitude with a as both manufacturers cost for cost transfection reduce I our to work major inside as we've system that to our outside United some this There uses two, for that quality you the develop reduced order GEN-X.

in United I the that polymer, a reduce said will the only for finalize and sources seeing China. in the for with U.S. plasmid fill and that in for the And component high two with cost this of lower third quality pandemic, United the China, Again the their Chinese, of We've have enough, transfer of doing this a work and commercial looks ships the manufacturing. source United COVID the costs, even that provide again its -- has than off European-based, close current in competition outside that's we're as manufacturer primary China. polymer regulatory an manufacturer we've a using way, currently magnitude enough, works costs as And substantially qualified step is, in States. like not facilities the finish recently manufacturer and to the Interestingly Phase this product the So come recently of by one almost in Chinese the finishing and of by manufacturing of redundant the for But cost of evaluated second approach to Their expanding manufacturer, one by and be coast facilities, its United States that interestingly may to our at concentrated order our agencies. result to we're in they lower FDA but again, again not the competition manufacturing current the down state-of-the-art States, island, the of sale, any near in portion process in product States. the the lyophilization. some been the manufacturing of it works. than China. both other for to II we finally, is way, The Again the supplier successful a virus investigational study, China, become are or product taken in

over plasma. period. So our goal XXX you a here of GEN-X have our large is of a the system six patient One for that month treatment because to of manufacturing, low know will a product receive cost, course redundant and volume requires competitive paradigm up to vials worth

So to successful ensuring but it's company's very to only is important important we that have very, the down product. commercially not getting cost the financials, a

Justin Kim

what sort issues? be that the bit of then better assess I sort a threshold be might just the to about gears. period there guess you maturity a a of data and of for observation meaningful timeframe talk OPTIMA little And maybe Could might shifting continuation? is potential

Michael Tardugno

Yes.

have in looking And we're would at a sufficient answer So, a to on I we study trial. number you mean either makes this easiest that until patients continue positive very is I number rate fronts. be, the it the -- just The that of this there's be in determiner a for or for trial death that. study the a potential very, is will going to hesitate a clear follow a give failed date, result

stuff. have answer only take we that an could we in now, the quarter appears sometime it if As fourth

some we'll some identified -- pretty of pointed just as to The out something and other sensitivity statistical investment immediate meet earlier to know very step the the steps may feedback immediately that take in the real, direction the begin your that we'll predictable the basis. soon as issue to discuss discontinuities with on us a is we're taking we that the and hope that give of And case, I the provide at of that are strategy. If from looking has to could maturity community if it's the analysis state discontinuities, of agency. then That's we we the FDA the study. course much conclude

Justin Kim

before regulators, of hop a conversations conversations just what in have of look might On maybe results point queue. And the the perception with the just unblinding like initial I with final study the study? light of you regarding the the had into any question positive and that

Michael Tardugno

that? of part first the repeat you Can

Justin Kim

a Just data initial potential on positive has feedback the with given readout regulators been OPTIMA, for sort the unblended? of

Michael Tardugno

we a have that not these, with more. like like better them had so bit call little conversation of agencies. know going some to have so to the regulatory I'm of discontinuity. understanding Yes, We'd We'd to

more So trajectory little the idea them we the the meet a better like and of a before of trial have agency. with understand bit

Operator

Raj Our next Kumar Brookline Markets. of from question comes Capital

Raj Kumar

With China/Vietnam, regard from terms that patient that do of patients of make up in with How evolving? these does the And the what the see different, on. that compare later to the you how OPTIMA patients percentage deaths trial? whole eight trial, XX are

Michael Tardugno

Yes.

about by pointed the I the some mean that to amount, good detail suggesting, and patients are a enrolled between here were compared few the as both to to patients the So to what the dichotomy median enrolled an seems Kaplan-Meier be questions. in out, us death Vietnam. leads Vietnamese we death, And Chinese can median Study mirror. XXX I there time been earlier of those in subgroup as interim than there on curves is and China vein. more immature separation the data time give to the investigators reach study The a the and XX you we were from in HEAT XX% positive on release equal that that as In same to What seeing of the the analysis prospective a believe we study have appeared the patients, the time us. arms had think, two first the we we subgroup, been With tracking, in points. compare and the regards quite to patients. as to it, did I press could mentioned to much of

look next I a a deaths, looking are we analysis, XXX. hazard the X.XX. that is interim was of Subsequently First about at so XXX ratio mean

in XX XX, a vast maturity the confined the may XX the are I enrolled died phenomenon. to hard arm, happen. I at the there patients could time was mean, and patients at reversal XX showed The died, how of a very when it's XX just arm then consecutive understand causative majority, looking interim it the reverse, patients, period. who other look complete additional O It's control also in enrolled, it's And treatment out So a had related, that it the or Kaplan-Meier, second complete treatment but we're analysis. factors. those had versus believe patients of patients XX arm. I for be you mean,

in expected part, Kaplan-Meier we have So it when patients would what out subgroup of as my when are HEAT curves the in with very XX I analysis, those the most for Subsequently, we from, the a reported on ratio we prepared those take the one subsequent said mentioned death, and we hazard every compare remarks, Study had much we to controller arm track Kaplan-Meier patients to curves. the taking eight deaths. X.XXX the three to -- patient earlier are have Actually for X.XXX. been ratio of interim more have treatment arm deaths there analysis,

Raj Kumar

is eight the terms that's the -- are in whether Vietnam? these from, where split, of the future the expectation that, what from going is And they are geographic or patients, drive to these patients China also differences? in So, even aspect, the

Michael Tardugno

Yes.

dependent period a that's of be issue, time also this being I So could were phenomenon it as which or followed. regional treated know, may a to. issue, may a these during we're what a of patients getting you're be seeing time a It function maybe like that be

we the mean of some sensitivity know. to So have that dependent, I work complete. yet don't maybe that's we time and maybe regional

eight far know As my patients from, where of that? come have off the as head. you Do I don't top the

Jeffrey Church

from China area. primarily were Southeast the They Asia and

Raj Kumar

to Okay. And kind what due to any…? protocol And expect bought COVID-XX? of terms the of you GEN-X, have in deviations

Michael Tardugno

Yes.

about careful answer So are I phone we please? been Nick and And can that believe COVID Dr. do you -- be to this position issue. Borys is a able question the in very -- on you we've

Nicholas Borys

you. thank Yes,

OVATION way COVID to throughout. need impact In a of all COVID-XX seeing that our terms They X anxious treating quite guidelines of criteria. for patients And lot them and we're discussing we our lead are extensively investigators we've of investigators. our aggressively on this study the with with They're Study, been are study. be patients taking the precautions into COVID during COVID ASCO designing following COVID for get forward to the going moving is period, this that testing and

protocol would missed, to the There might be may being not minimal. endpoints be major I but I visits impact on see the expect be any challenges. There occasional So deviations.

Raj Kumar

what expectation terms of by NIH kind -- in the analysis, And the this from analysis NIH? the Okay. of what is

Michael Tardugno

a and minutes more it patients had NIH had at Kumar, heating who the by time. NIH, a our at published Recall, the look company. subgroup was to XX of was than different conducted those the confined look the at and treat So, developed heating measure with for are And algorithm that the survival. the patients, analysis can an heating between relationship patients, time intent the side-by-side longer looking that precision. single they population, shows the those to time agent data ones

NIH, expect So the data plug the concern very heating times have maturity I'm evaluating volume. I here. by this of a is And for what sorry, a tumor do were function their into important as data They point way, we we missed model. from this since to

of to modifications. issue. this that them They maturity into for be Or And so the may we is should could some plug has futility it it high analysis potential may correct. there to our data have either being the a wait that that will a But model. we model that want confirm confirm make us expectation

So that's expecting really what from NIH. we're the

events in is PFS if use by their I reported radiology accurate. model the address from still at not the like please, you think, the on looking also evaluating looking again, of in NIH? study to we can seeing the PFS. whether And PFS, phone, you’re the are know overall the Nick currently We or patients We in the separately investigator that would for are

Nicholas Borys

Yes.

to volume-based NIH’s a meaning analysis. was slice, they stated, data, a take view the particular different did Michael a of different As interest

PFS rated there's anomalies rated going the the said, first to curves help Michael of Study. the to will similar them as there, and we we're PFS be that significant the seen we'll in are and So by we'll apply kind same question whether there. then analysis for or different, any determine HEAT to versus OPTIMA that is differences the is look expecting. see NIH central from whether done there's did Study And any lab us be going to would it at investigator that And what reproduce to see if the to be

really trove So look at compare we’ve HEAT what the of be Study. the to and treasure good the will a in take data how a to it data OPTIMA learned

Operator

Our next question comes a Investor. from Landgraf], [Mitch Private

Unidentified Analyst

regulatory want advocate work cancer and I and investor, the with company a patient commend efforts to to Celsion As the of bodies. appreciate all

hopefully However, fact it's bring possible that know to safe. We to it's the market. drug this

COVID-XX. and totally that for possibly partially March those causality this time radio or We with their from also Asia, different an like and investigator the hypothermia whether Southeast itself, effect. frequency patients I these patients. company was this anecdotal patients or and know anthracycline -- the And the in ThermoDox if want that complications of question works. perish XX? of is entire is whether to to any of from those probably obviously, it various COVID-XX want of drug its than wondering that whether any as an system My the data would immune patients, ablation because was on the novel there’s had And I arm or the from thoughts would treatment question period seeing consistencies we'd COVID countries treatment does for interplay treatment were a their seeing XX the fact Borys, that the our that, of possibly I anomalous in know Study and from And because the some HEAT experience Dr. not interaction -- hope to-date. December a available like possible a positive more And having

Michael Tardugno

That's a it Borys. turn to Dr. great question. will over I

Nicholas Borys

you for question. Thank that

revealing all now. a possibilities basically just study. and are careful And me we say death And of us always an interviewing that as during to consideration of evaluated if these impact. data much an right the watch Let Certainly the investigators to there we COVID were give causes on make was that. see collecting we and important sure that the insight were into patients keeping wasn't being for are more they we're

this data. are taken we with well possibilities and So your have points all been considering

Operator

[Operator Instructions].

next shareholder. comes question from [Judson a Our Porter],

Unidentified Analyst

questions. couple A you Good morning, gentleman of and thank for the holding call.

recent ratio you the If been, continued deaths the would of to statistical First, end produce? I be eight a X-to-X to the study hazard deaths of have that the to as ask what want balance for projection. the

Michael Tardugno

we that know number that Yes, be looking But the off exact I continues don't that give -- would you off top our at I trial. we it of if at can heads. this number rate, a believe successful

Unidentified Analyst

that XX% going in you Vietnam and in or over other?. the of question points press the from presented numbers language present China out a is overall from clarification. that in OPTIMA, deaths the Secondly second a improvement both the overall combined, the over HEAT, XX XX% overall very from survival in release percentage between and of careful increase In survival experience in survival, grouping dichotomy the

Michael Tardugno

Got it.

XX% -- apparent what talk patients we When treatment a the in this you're actually in arm it’s Study, OPTIMA the those death, in to dichotomy. improvement So median about referring from China. to that to the control arm improvement time the were compared is that XX% a comes treated

a that So that by a spite of small arm where in arm we patient’s It result. we in We Chinese of at early or plot when look take algorithms, the shows take there's the negative the each median patients. a then curve but all still death improves on negative so number time treatment them And time -- a we nonetheless. concerning control on median the through see very contradiction, patients, death of result curve. and the Kaplan-Meier complex pretty actually of goes to the XX%, death, to crosses we Kaplan-Meier time this median, the a

the in the -- answer in and Kaplan-Meier your those curve median those So Vietnam are question, are specific the China. Study survival and to OPTIMA those comparisons, in regions, the coming overall specifically, from

Unidentified Analyst

you you I survival X.XX arms have and substantial go ratio question up still wound X.XX excess, that's If is One more discussions other that. various is there's with answered hear. approval to end, That's speculative. of consider when study would this hazard that is already enough to the to no reasonable Is and of to of approval it the be treatment. which a still the know encouraging instead very a successful in with to may that assume complete, market? very And your

Michael Tardugno

this So quite we a kind debate bit. of that is question a

[Judson]. important very is end here, the So

a because p You a good have hazard can very equal of X.XX. enough number have to don't have ratio you significant but of to statistically that confidence looks patients not

even this committee do what that believe ODAC ThermoDox to And be important we should of we the So given not in very, I that approaching XXX talking those have mean here. product’s factors manageable. point, -- a XX we're see may really treatment median closer or the FDA. arm, a the effect the if then magnitude the this We to time But will I administered in may well demonstrating X.XX profile profile. two know commercial something a regard. to in maybe is particularly for discussion your we the that over far control a And with we've months, or are ThermoDox believe is we is arm, substantial patients. think, consideration deserves and to safety about, death interplaying be for to what in that's And the very the product, death effect that to never safety not received improvement X.X, be so we median discussion that time in the magnitude It the given with ThermoDox. seen well very drug quite of whether now is an

Operator

like today's presenters. At this to I'd have it turn in we queue. back to time, questions further no

Michael Tardugno

certainly very you your your much, of attention Thank and call, support are in the your and operator, appreciate who for interest all on we and you the company.

you some As going see, time. challenging we're can through

I However, of analysis. continue very we to don’t dismiss will potential where we we to as out said thinking by as about what and I point any want do you're evaluate GEN-X great the earlier, Please, ovarian OPTIMA And as means. be we as cancer. expect to analysis a has result company, transparent in that data that a the the -- with that our

continue a will of the make that a by commitment is difference potential great families cancer driven be we our to therapeutics. to So and and We there know patients for these patients. clinicians to

we are of look committed Thank that. much We keeping for and to time Thank your apprised you to forward your very progress. our you.

Operator

you, today's This teleconference. Thank gentlemen. and ladies concludes

disconnect. now may You