NAVB - Earnings call transcript Q1 2019 | Navidea Biopharmaceuticals, Inc.

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Operator

Greetings and welcome to Navidea Biopharmaceuticals' Q1 2019 Earnings Conference Call. At this time, all participants are in listen-only-mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. CEO. Latkin, Jed Mr. Thank you, Latkin.

begin. may You

Jed Latkin

call Good milestones ended afternoon Earnings I First XXXX with of first Biopharmaceuticals. to the operating discussion financial results a for the March welcome, My name XX, remainder everyone, the of This Navidea Call. of and XXXX, Executive Navidea's cover is XXXX. Navidea's Chief and for which Quarter quarter Officer and and will on Jed am along goals Latkin XXXX,

statements formal will open of question-and-answer as early and and we Erika we of Company's concern materially like before to I of statements results numerous the commercialize and within Act and this Company's Officer, the anticipates, to risks conference and rheumatoid remind matters and conference on expects, Following call forward-looking bodily the and a arthritis. forward-looking indicated remarks, These some forward-looking suggests, amended. our Securities Chief the or fluid-based the our intends, materially that cause identify XXA Science may goal, plans, risks begin differ projected seeks, Administration, relate and due uncertainties up that Section such of Section targets, call to Mike diagnosis optimistic, well Words actual ability Regulatory Rosol; would expressions of monitoring Bill the Finance anticipated potential, the our diagnostic as session. that aims, on XXXX our Regan. as cancer, Exchange Medical as test prepared That everyone XXXX Dr. Gibson; statements may our those effectiveness and these differ me from for Company's platforms of develop forward-looking of as Chief in be in statements. statements But those With Officer, could uncertainties. successfully amended and Act results to considered such and the the estimates, Director call detection XXE similar Compliance of from today meaning actual forward-looking of statements. The involve to tests, is of believes, remarks, our to Officer Securities

XX-K as assumptions with listing in Company and in the based estimates the not recent Form fail other and For other are maintain on and be involve assumptions that our to products, products the execute Other its clinical to competitive statements IVD risks as by competition Exchange, Quarterly highly diagnostic expectation, and regulatory the marketplace rapid Exchange to Company's the control the of New diagnostic to and the clearances Company and we due guarantees obsolete develop; to difficult in technological diagnostics These plan we the market ability files Securities outcome part, inability uncertainties accept current other failure the of will Company's nature might are business are by projections Commission. that obtain distribute in the may products and the of statements may development the of face Company maintain products risks, market intended the if our any or with fierce any litigation, predict. on and to unable Company's failure necessary a develop commercialize pipeline and to include performance uncertainties and risks York about approvals the Company's Annual the Report or financial instance, made based, future to become These XX-Q, operation. management. reporting, effective to on future change; identified most documents products Form pending market; over Company's the Reports internal and and well on Stock

the of its an future of as by obligation statements or date forward-looking and to update events law, not to Forward-looking does conference statements undertake as circumstances. call, this the made required reflect Company except are

Now me update. let start with the business

to Xb and involved. Let the strides RA tremendous Phase well been this has all company some Not necessary the in on bringing job the required imaging qualifying me a trial months. towards we towards are we've our my NAVX-XX for it. recent a made condition the to the that review to designing was elaborate laser-focused proprietary this company's will patients the we but with simultaneously begin all sites milestone. enrollment news done. was protocol stabilizing in obtaining announce to month the institutional the FDA's mentioned but enroll update a a officially only Today Congrats begun to have on and undertaking call that of have that trial. I made We I'm Dr. trial path They on team very agent by proud Rosol our realization, recognize so a significant approvals emphasizing forward. closer in and progress extremely following am for financial also Xb in ago must fee while the aligned of clinical in comments, to FDA proceed. was expectation Phase proud small This the FDA's excited accomplish board that

very year. front, start On a to we active fiscal have had development the the business

Showcase CVA proven held in has and engage with January Biotech We BioPartnering highly Francisco be imaging in generating productive participation the to to in and several San players major continue our the in Our interest substantial Conference under technology. discussions with diagnostic our productive XXXX in JPMorgan in space.

to first on in a major investment This We direction. is years. firms coverage several for time step right hope also the in analyst announce the number a the video prominent engaged of and

have advanced to very some hope future. imaging We our longer well-established near very plan. partner use involving busy, has have the vetting team talks pharma also a of in announcements The to collaboration several number interested exploring commercialization condition. inflammatory with in companies with also groups trial the in Tilmanocept term been We for

X.X the potential for from other our does insurers clearly We agent would healthcare importantly, game-changing Americans, being and very hold. not disease. XXXX. will in X.X with We And what are healthcare that nearly of partnership value mean reflect development this the that right most a part. the the include product progress the That's to terms let the primary and goal me doesn't mean business for on a the all diagnostic inherent and what understand world. under Securing right this, partner not Americans RA around all deal that to million it the would stress we is industry patients very company encouraged debilitating this the by the just our million suffering the agree made the RA feedback

our the with We quarters over split also monetize which the a U.S. effectuated with that for over partners talking mandated the our can we more take other negotiating important hopefully as to having our we detail maintain will financial the extension, and on XXXX. such the After Rosol severely delisting order handicapped would compliance option to and company note partnerships on will front. the that, we so York flexibility be like announcing in I XX, development not New reducing Exchange for to exchange next complied. address global. It to financial deals With On partners. and Dr. have I'd want currency that action this something use that with to when it was and the is that to security Mike? hampered reverse April rule, granting a Stock flexibility. several listed it's future call turn three severely turn both do unprecedented an by of

Dr. Mike Rosol

up in today's you'll our I with the enroll Thanks, going you good first to following Jed, on Tilmanocept April news and X updates want we've and investor participate patients subjects with our me. on active call evaluating of begun that to subjects imaging Phase and hello, call, hope readout and reiterate I reproducibility happy in healthy Xb many so side. the our RA. patients stability the to here bear in our clinical everyone. with from to I'm touch trial provide I'm

highly and showed of of we able RA. point to move patients RA. This are joints Phase joint with studies X Tilmanocept study no to of with of signal exceeded patients empowered our about with our we have intravenously-injected excited Phase will robustness thank first all. signals the injection publicly successful so very as to of the X to can Bonnie to that X rheumatologist that recall localization to this the and conspicuous. Tilmanocept, now RA. signal trial by consultants a patients of Phase active the arrived demonstrated us healthy our trial You'll our signal were the showing active safety the adverse potential In we doing of of Xb RA in Abbruzzese test/retest signal diligent definitively of to short, and active subjects getting from work images imaging RA joints were time, in between the the from clinical this from Congratulations understand the team subjects like with signal study, versus in quantifiably. healthy operations the and led the going. really them prestudy and the study -- localization with for healthy Tilmanocept at Tilmanocept the see well differences subjects imaging I'd defying the and completion subcutaneous And of this evaluation X after we control results RA be as expectations, Phase to for The compared

trial Phase might of increased also mirrors to this and planned that recall study enable contains power this the a us that X You arm with study our design confidence. will that third that

later Currently, and trial we data for make continue We roughly FDA situation distributed with with trial arms. back XXX the of out Xb the That and plans. way the X you subjects, plan is Phase in come total move our our this and along with X with keep readout very We'll the will planned ahead subjects imaging plan performing is continue converse enrollment to to we're interim to be correlation in on apprised in them equally alignment Phase analysis this second Again, this three histopathology to as sure the these year. as with of in Phase to reach the study. we FDA.

are focused pipeline. our on continues we other I While research currently, you actively indications of that want in areas to our RA assure

tuberculosis. by Gallium-XX the medical looking to use strategy label Mike or Dr. You've with either better Sathekge fits This with instrument in would given base, radionuclide. having UCSF Kaposi of a beyond which agent seen labeling the to call, It radio South case, at look at of in-line is greatly than A about for announcement indications in market a agent a gamma-emitter in this nuclear Tilmanocept imaging characteristics our there's with study we a at of of discussion shortly. agent study could of imaging will work is the and looking Africa, our this and PET and study continues. PET useful pilot labeling rather versus PET disadvantages address. a currently-installed study far performance setting sarcoma urgent larger Gallium-XX PET of this up PET Technetium-XXm arm Tilmanocept as researcher a Tilmanocept well-known agent Africa, medicine the worldwide of is the to versus able the use keep in initiated appropriate is of South for the be comparative advantages availability agent. run capability an where agent. provide need and SPECT of expand this TB to provide also us the the are scope us. but strategy a information SPECT This might imaging certainly fits SPECT being our to our that begin In a

diagnostic recall clinical -- the have one You'll the grants on therapeutic two the them other with side we preclinical on ongoing side. NIH and

the they things On of by some recruitment we path following to open summer. analysis six with from we is they The would discussions front scheduling in side, out to and can wrap subjects them promise fulling plan the is complete to end issues but more on up, the clinical easily. worked FDA site an No more that for can this full S&DA. and and of up hope up be think about study enrollment course, enrolled

preclinical IND. front, work and to with we other FDA and preclinical continues with data about that the a On including wrap and plan safety possible year discussion next this up efficacy animal later steps

progress Score-matched the of HIV-infected group. Framingham begun with at is Currently, We investigator-initiated evident Risk keep him work Hospital. ongoing imaging Grinspoon is talks This of building at to within Tilmanocept we atherosclerotic to plaques that Steven next with Dr. look also upon published We'll atherosclerotic provided this detect and run and about there discussion with the continuing enriched General have plaque controls. healthy this Massachusetts ability patients study in activated support study the his macrophages. to studies have

felt our trial, data on Regarding imaging. comparison evaluate the NASH to colloid cohort as team that out the sulfur recently PI be the closed first that and we would sufficient the to

weeks We will in the be and the data fully let outcome. you coming analyzing these know

of Path preparing this this their come document think so registration to be development with actively you context Institute trials pass a on a FDA arthritis, FDA as qualification will Based in be to discussions, that first submission them these for Critical will support our we RA. selection CDXXX process. the for the Regarding ongoing and ask to rheumatoid prognostic and required data to I'd drug as continue use be the an the of trials, work we consideration. subject from used of should with are biomarker intent and aware to biomarker begin the the clinical process in of for

We to provisional are two portfolio. patent IP also We our continuing filed since expand new January. applications

deals Although our details, I biology. to in second two image tell We the I'm quantitation will get of the before provisionals relates these into with end. file fundamental much likely liberty year's you more can more too not that first and to

We and the play space. that partnerships mentioned as collaborations companies also discuss Jed with in possible continue to

Phase lines, into and So summarize Phase focus Phase along the for Xb Xb as enrollments that just and to remains as to towards our begun second clinical on arthritis a study want rheumatoid and be moving first prepare plan I our to main as and well continue product those approval and the reiterate, we've clear X.

also are preclinical other push and to areas clinical research. you. in continuing We in ahead of our Thank pipeline

would the Now, call turn to I to Jed. back over like Jed?

Jed Latkin

to and stress summary. really the done forward. that to ball Thanks, that appreciate keep just want have for you need I thanks Mike, and guys everything that moving I we

using go updates, see our Before the products through new to note that It's focus call some where I direct the to in reestablishes phases for call our of over deck these turn after going this into over can wanted everyone financial just just getting the this commercialization. website our investors months. Erika last few the we'll deck that RA upcoming to and to be important next I brand our forward presentation everyone through conferences to on the

other market working the new that as a see go to You'll of different of the of going such that lot parts information there we're on. looking size of phases and we're for the trial be to

move updates. on let's Now, to financial Erika? the

Erika Gibson

sheets, equity XXXX. balance reflect statements and operations for of to consolidated restated it split statements Our occurred the January reversestock periods as all presented been of X, on have stockholders required as

standards Research the lease new XXXX. resulting the compared the was of grants reverse of to supporting offset XXXX XXXX Tilmanocept first by decreased NIH XXXX. for net standards revenue to cost, the the Our Jed. compared offset of of to cost cashflows Navidea's January in decreases decrease due sublicensed of XXXX compared Navidea investor drug effective And legal period in decreased and decrease new Selling, development lease for in in of coupled was loss to attributable to investments. XXXX $X.X of Increased $XXX,XXX, over and and impacted million professional first first consolidated salaries per ended million for were related quarter administrative GRIT same approximately or was the to lease call stockholders compensation to decreased and XXXX the accounting the Tc-XXm $X.X net to XXXX. same accounting and $X.X first million that, due increased in XXXX. and from or and development, period split. with for net from with in net $XXX,XXX share statements $X.X primarily million quarters a were to the cash of to and quarter services primarily the back turn by revenue compensation therapeutics of will period Total $XXX,XXX by quarter to the $X.XX per adaption decrease project loss of and relations were $XXX,XXX were were including due first $X.XX related expenses expenses share FDIR same I reduction quarter common the development a The cost. expenses common with in in attributable headcount. each revenues X, general expenses the not The XXXX. stockholders Manocept

Jed Latkin

There message for promise conveyed we're now Operator, please? answers. today. open this up to I would hopefully, can all, us in and and you If what is joining afternoon. trying great been like that the do it's you, to questions call has Thank here not, for Okay.

Operator

We'll first ahead, sir. Thank now Instructions] [Operator be McCarthy, question Please conducting session. Group. you. is from a question-and-answer Maxim go The Jason

Jason McCarthy

Thanks taking congratulations on progress. guys. Hey, and the for question the

Xb, data a on Phase sort how of the what us individual multiple of endpoints in metrics patient you'd for stability? over be it an time? gather bit to And the would Regarding long take assess take of to and could As image patient? using same a kind you images you be Or give one-and-done? more it would would color

Jed Latkin

that. I'll Mike Jason. you, Thank answer let

Michael Rosol

worries. No

good question. Sorry, Jed. This Mike Rosol. is Yes,

Let what you see if heck I me the asked. remember can

reproducibility, We're right. indeed repeatability. doing You're test/retest,

It they version variability. the looking is we are scanner, well. with they short on the does that do off on scan scanner, in we'll the that What subjects get with will example we're get get where at the of as gap between injected they means there them, So agent, means? be that the and the our back for all times

then on same lay orientation. and over image and after robust? how imaging to down hours, presumably looks. this we're going then another to back So see one matters we're between And back of if three one get that the going time terms in and look readout the is at in scan Requiring they

a the well is robustness as time gap So back scanner after off and as a of getting scan in little immediately there a between. of on bit

Additionally then a back repeatability disease a week going how active for looks. reproducibility a to we're do the later the that to see them to and later longer. going relatively and periods we're stable, being presumably and how patients going that also call We're with week see bit short RA, scans over and with little those

how look as the robust have our active -- of understand signal the can can how towards their joints, kind feed to control what metrics who of of able about looking what with enable joints then we'll well X what's Those data, and healthy readout what attribute be these statistical a of as the is chance. roughly half to those the when healthy confidence change, X. the versus is X in the for enrolled all X. obtain of typical kind patients we're are and is So also same patients beyond doing with of and should to information arms a us person change RA, person's variability, to minimal we in that be in we'll does our again, interim arm a of are what signal, start RA. the analysis active That detectable And our confidence in us a person get healthy like, goals is

arm then parallel, in is the for Does be an have arm the patients that controls, X. healthy make and So active the We'll of Phase through of X X halfway we'll with the idea course RA. pilot sense? arm are recruiting

Jason McCarthy

market X.X like at at the Tilmanocept sub-populations in where you. or particular Are we opportunity U.S. market patients if It's provide looking us a tell I'd the RA? more some could we in could thank million see there are specific helpful. also you how the should Yes, broader benefit? look of very to

Michael Rosol

you let Jed, that. I'll answer

Jed Latkin

it's I patient severity treatment on decide they terms action. it -- have it's the to because interesting in idea we're and what the virtually newly the patient know depending do get that used want they hoping scoring comes think our and of implementation, next the they what by of to the patient in is course what a every doctor there diagnosed outcome the Well, be the they'll especially is an because question is really get on if out to will scan, going -- is decide the would

time, they to or in and a 'Do them come period another put they So, whether been that a will some get show on scan then If on will after them want back, change we put not certain there biologic a inflammation. biologic?' has set of the

patient have any our joints, every don't RA, virtually been able ascertained that type we tissue heavily is diagnostic really is have of of have is probably What if and product. hope sort that really, to pre-treated to our the have you going in bad your be will So any work. Synovial left use not

diagnosed billion between on it market progress the depending year as RA We just the that to diagnosed population million encompasses $X treatment. every continue is. every see as this ones the your on monitored feel are six a be we think our and that stable on you're year in of we is who a there be of to score So monitor somewhere to market. you'll you'll presentation or will both that our newly what long multiple months optimal be recently just stable every scans because therapy, That the are most and $XXX feel the and as posted, sort we do and that

be long-lived will it So as product well. a

As to scans. stable, continue long those is your as get you'll therapy

the However, again. over if you we start start to of then see clock inflammation, tip sort an in up

six or You continue to doctor you with then do do you months see it. whether and the wants year new back score probably treatment is and new then them new depending the the on how to on come that continued scans quickly not a fairly scan, a put you get onward every then working therapy, to

But to get the the patients all of them do allow be day to subjectivity decision the will long-tailed pretty had knuckle it's majority going squeeze, So and onto other term. outside the the market time. the make a very quite we we're pre-treated heavily vast It much have will it rid objective capture product that doctors really long us going disease. it of of very patient on that see, for those as and that you of to the severity to and able for keep will capture a one can feel disease long be for stuff, of

Jason McCarthy

Thank again, All and you very congratulations. right. much

Jed Latkin

Thank you, Jason.

Operator

have We a from who Please a Rick question is [ph] sir. ahead, Drew go investor. private

Unidentified Analyst

and afternoon much it are the along you Good voucher thank clinical wish that we Krabbe or in very the pass Jed, to this [ph] for on to you you for where update whoever goes perspective. process? to. Relative to the disease,

Jed Latkin

to material next the we we have time on a next for the the you when situation. development university the bit litigation Unfortunately, to are CEO are we'd I continuing As in of to know, Macrophage, so forward forward. do ongoing is need was data spend the the to sort the University to expect of those within of don't Connecticut doctor spend are we to of do I legal the a due moving Goldberg. continuing is continue continue there, and that we do we that with whole to the test, get of but move trials. delayed would money say that that. former quarters. frame I to issue we should Michael couple to need I continue to project Connecticut, have say Dr. level we with would on But of What

Unidentified Analyst

be then? is Therapeutics tied correct? what was Macrophage Is that directly voucher then That into to

Jed Latkin

smaller business, then the voucher yes. and -- Krabbe you disease, what voucher part you it's we're get this program indication The pediatric looking voucher a when therapeutic comes of approval. it's with is orphan at once for the happens get you go Well, about the like

be be but work. would But it So of you, to of business, Navidea just one of remind Macrophage, part the it Navidea, currently Macrophage as part how at therapeutic does would voucher the is XX.X% Therapeutics. own of part that

Unidentified Analyst

held the that again, number scheme why you just of in Thank is so small in hold by would things ownership. little to the percentage such previous don't then. a flummox CEO But practice That's terms update as like then being for okay. as things a I'm of law, up a large that. I that

Jed Latkin

Thank you, Rick.

Operator

We who investor. a go private have ahead, Please a question is Paul sir. [ph] from

Unidentified Analyst

Good your afternoon, the rest Jed, and staff. of

sort I've you. twofold. like do First My like Number what out all a [ph], want what But one, or company see through how another see to go million, is I company going to what raise And shareholder. here great we to the to company revenue with that's of revenues? some go past of I the far I the can seen see. carry before not I'm or the some income to that changes. company? to thank to question going we $X.X is long-time I obviously get level, do maybe quarter even two. I

Jed Latkin

two-prong a That's of sort actually question...

Unidentified Analyst

Hello?

Jed Latkin

Hello?

Unidentified Analyst

Yes, hear Are now. I you there? you

Michael Rosol

But here. ...Navidea I calling Jed. lost is think Jed who have in, we might

Unidentified Analyst

leader. our lost We no. Oh,

ball? can the somebody so up Okay, pick

Michael Rosol

dialing He be in. might

Unidentified Analyst

He'll dial I'm sure. moment. back Yes, him let's a in. give

Michael Rosol

is queue when go Paul, hold for Is I want to one be right on could the with next he One back. fair thing know but you? that do a to could I here. question we there's calls all that and we

Unidentified Analyst

problem. No Sure.

Michael Rosol

to get We'll it.

Unidentified Analyst

Okay.

Operator

for to dial Jed about in. wait We'll that am I gentlemen. back sorry

Please a have ahead. [ph], Mike Russell go investor. from Mr. question private We

Unidentified Analyst

until a a he any a to today, that NASH you according have trials actually wasn't them were read SEC gets I I That's have the Thanks. but saying you're Can Jed would why could believe NASH awarded failure. trial the failure. trials? couple. more NASH way Michael, in what was that could early, you Maybe stop been back filings? it on. give The color that It answer the on

You're just taking Is too. approach, different a that correct?

Michael Rosol

cohort but was what the actually next a Yes. I want in dose to I lower careful be say, here cohort.

later to more qualitatively and at data the just it if waiting the an say images analysis. a to without and a staged we of to than too the decided got until control healthy where compound. fairly the since our be what fibrosis. were of dose, we further was data terms is going cohort those the the enough and strong with that them colloid colloid robustly decision comparatively, the colloid at them rather imaging What lower if Tilmanocept quantitatively Tilmanocept we see can't advantage those And thought decided come some but image having with really the are we NASH look Again gave at we where towards recruited revealing probably down quantitative I sulfur here we So second to good that comparing versus digest with us us the lower there quantify. livers patients those we've sulfur road dose much, liver in address really over later benefit differences their enable stage to the were we're disease, said and would sulfur and quite idea any, can imaging. people But similarities clear, isn't to were and maybe there what

these and or that So to enroll maybe in want about cohort earlier have quantify let's at stop to trial earlier look here, it just we inflammation, the second or patients or redesign think decide and the disease data then what. who if earlier

after these what make that determination, to next So data. Is quantitatively analyze helpful? we do we'll that

Unidentified Analyst

clarified. is that Yes,

wasn't a just it's a failure, continuing it So evaluation?

Michael Rosol

Exactly, yes.

Unidentified Analyst

it last for one Grinspoon. Hospital, It cetera outcomes Manocept XXX HIV identifying on to one for you some supposed that question General completed This All 'The his an be -- and have Grinspoon, I Mike? has the of up right. interesting XXXX and it time had cover was on biomarkers. it's the one, application IV-XXm update with My do titled particularly brought patients. you imaging was it to didn't Macrophage-specific Massachusetts new the trials. next Do of et that was inflammation' to in soluble April -- that

Michael Rosol

the have was the as folks and not gaps first me as -- call may happened What let aren't who fill in the informed you. heard Yes. for

that moderator. cardiovascular concept answer. of was sorry in proof with lympocy Grinspoon The did because Score-matched of the interrupted, versus higher we that's by first a root we kind the Hello? folks general trial of I'm events who for approved subcutaneous Tilmanocept I'll keep for Risk think [indiscernible]. did administration I Framingham is at we're HIV in are where risk what just

trying a glucose-hungry the what of idea we've on Currently, just number Grinspoon the now research study imaging else recruiting utilization. more it's So world the going the you patients to That's to administration. everything at data, look he's X FDG is forward those of on where there's done. and activated rupture. plaques, leading data scan that The macrophages. to tend patients the body of from and then that people where are more video glucose vulnerable for machines. vessels of the point and activated a of are using who at are is lot doing going here that and plaques, have in more route as subcutaneous the what plaques we're whole IV looking now building small And though that Phase those, to atherosclerotic folks. as at up literature plaques on the in to point your was are that's long or IV there's separate as that are now with enriched your is PET. of It's that we macrophages prone proof going carried who Those thought body this be and a look to activated central concept those and are be with well a so-called of a we're macrophages Main PET

so However, time kinds is background you background up signal of high of latent The signal those -- rest glucose much this all body. very heart is images. itself the chewing so in the of the have

true activated the the is versus FDG. because We targets think The will to over Tilmanocept, provide that So in signal you're an background. signal macrophages specifically interested low. it background advantage

So is as he's update forward a data. data collecting still IV on them to enthused, soon going recently. as have this the those flush of early route He's he and very you. patient some good spoke of administration version Grinspoon data, short of got we just Good? and we those we'll all The out is to cohort

Unidentified Analyst

Okay.

non. a macrophage he's those that second inflammation question, was and that second he's versus where at a second XXX with was study study ongoing, The ongoing his HIV-infected specific got imaging looking

looking [indiscernible]. basically just it's So

Michael Rosol

and investigator ID. on same have X study to thing. sub-cu. NIH about going Phase looking the is with that you're at speaking we with now. have was the at, initiate That's The the IIS that's look I'd graph study but That's exactly the what the one you're him the

specific with plaques Jed just normal he's further are the folks be the difference he's detect ball those to because general. rupture. -- the and he he's to when who this able the who he's is us these versus looking Score the in ordered is to What atherosclerotic writes he Risk to are detect wrote of at So saying, don't similar those HIV-infected here at advance The title to are high cohort plaque So long broadly. doing term the towards on?' plaque maybe before likes Frammingham do vulnerable Jed risk macrophages you have rupture people using HIV and population. early as play 'Can matching

you to to outcome saw example, But where same signal that in XXX need folks of these think a do mentioning patients didn't is surface say, were marker of and we intensity coronary vascular see to going have 'Hey, macrophages. the indeed where form likely I they high and more that's some vent study than study You're when for some we it.' you're a cell significantly

I would That's excited what of us plaques Tilmanocept they there. a I've rupture. help means we you're big he that That all for well. about be if are just He's think can using And -- seeing referencing world. the and what vulnerable what identify said. is thing before Good? that that's he's language as

Unidentified Analyst

in studies Google to imaging. and is on with papers disclose? in The great. identified other in that Ga-XX the at These through TB. in you question of are part. renditions liver, CV along it's line One anything Is couple there Ga-XX, on One Search in can the been written usually imaging Ga-XX the follow-up also or ongoing Tilmanocept another Okay, the and possible more cardiovascular liver there's a that. science

Michael Rosol

we in you reporter in to as do are like not it's imaging. would able Gallium-XX, Again, either specific mentioned in. ones as a S. reporter say. it well Mike it's our swap collaborators not advantages versus and are specific or South a are Africa, clear those it and But there ones SPECT be Those much do case Yes. think I emitter PET positron one. that involved it's yes, can PET ones to out not being using a us. widely with collaborations In we used That

Unidentified Analyst

for Okay. Thanks. now. That's all I have scientific on part the

Michael Rosol

Great. the by think And way. Jed I is back

Jed Latkin

just about It that. got sorry follow I seems I to wanted Yes, that disconnected. up.

to continue potentially I be that also looking think, cardiovascular Mike, in South also move the TB TB something individual the that who front, was is working we're towards Malaria, funding revisit if was really on working a with. we is hope potentially Gates to we we before. Foundation involved show Africa to by the there that commitments what from as him with on. we'll on forward in as That And lot TB, types in to get question certainly indicated on the others on of think disease he the there paper really of due hope to this, we just I Africa. is eradicating the show with I wanted the other to and

grow. over hands, selling lymphocy to the Obvoiusly there. question, genus on just product expect of [ph] be that that's can revenues to the that's think brief European I our we time more out the revenue On answer,

in Japan areas. for are in lymphocy also We couple other potential a and looking of at partnerships

have towards Chinese It's moving with would that there. the India, target. in They're product approvals that's the forward they As that you a China, situation, like, are regulatory moving working little we're slower need. but a hope In gotten we the we're approval just know, [ph] we ball forward there. moving than the the we then bit they

now. partner generating are side to trial to Gallium side in revenue so trial, bring greatly is arthritis partnerships a year benefit will We're it hoping a on That once money us one process the to time and hours. maintain do the revenues who's basis is stands with on But because looking the like discussions more importantly, we not then XX, the expecting necessarily very product the able not there will stands arthritis. We're shortest set be partner they'll can program, within partner with partnerships deal long research within this to within to XX-XX the they the that and imaging the global that rheumatoid RA so. in up the somebody is of individuals or the what gets some work be and at on potential hope the really in every well going to all we're type, for a tail approved, image, very, We then distribution to there, major be selling several share product. next rheumatoid the different data imaging on within this for receive the need we've a over to either looking we'll that on We're we're because that do do hoping a right product on U.S., U.S. also agreements way looking the or the partner. just commercial to something the we'll

said I what I back really move to to I earlier think have today.

dialog to share, has but the of the somebody we it patients very we and of into somewhere imaging deal. currently-treated future quickly, market If -- that who's an which more not to discussions, to deal between it's our I'm a as using our to just all benefit just patients want to RA shareholders. going product. $X we that that right while I've gain hope we do look commercial down RA that share all a to be just at we continue we sure value they and several to It's potential important right We so deal agent, The very good have -- website order road, exercise people distribute as have to to that make have partner, this the our many and in first that the and note going of presentation means going that's it announcement. And make the a understand imaging forward. the that the these $X.X agent importantly, a we the hand trial efficiently diagnosed options, this company value to do the equity protect optimizes to Mr. make make the as newly we or billion Scott optimizes that of revenue use we'll line enrolled possible. deal patients to on will this goal. we've other seek with value who eventually looking We're it billion to continue about distribute and on to ball I our will continue you a looking partner's right ultimate this negotiations our started, spoken and something really product to is shows this, is products. the While will I'm feel not to that the the can the move now maximize gets product new do many

those the question. questions, hope any can take that Operator, are answers if other there now. I we So

Operator

I'd There are over like to further time. the this comments. to turn questions no for at back management the conference closing

Jed Latkin

into First the want question queue. today. off, Actually, you up it get can popped thank that? for looks call to the just everybody Jerry, another I like

Operator

next The is who a question private investor. from Mike [ph] is

Unidentified Analyst

Yes.

Sorry.

cut got off. we Somehow

to see a from revenue. mentioning of where lot discussion were potential revenue. be generate non-registered progressing Xb year, any to generate phases biomarker revenue you use? a non-registered any Do biomarkers there Last the was You cases on there would about that any with using the you're

Jed Latkin

excellent question. That's an

those other the indications we other tap pathological we ball be approval the other Xb the important it for going The Phase of XX like but indication, where to feel approvals the further the the we're we on able CDXXX images main group. having with and partner. that hopefully they're able partnership think FDA it could and our that the was to really sort some very a think And leverage ongoing start bang as the indicate sell I anticipate the things quarter, in clinical FDA don't get but at. as that started But to get is have, biomarker the will biomarker, these that. buck. One, get for in, part moving and the that coming process start have to us soon XX get of doses that with for and are with but not then of to the looking we're able biomarker that are this data that I some be to really first we use like as whatever confirmatory because biomarker that down we use part not as data. we're trial as usefulness it's because use us we're did is most need doing, RA, to discussions that going and as that it's am confirmatory pathology the coming I hopeful we'll into very important images to forward necessarily get the we we confirming a get the for allow anything them where I of purpose will XX images get of that to data phenotyping

started I is think to But people bit had data. one of did of to partnering about pathology us side. that the little we're going before biomarker have ahead should the we a start on we biomarker the ready that talking make was ourselves the and that with we that XX things

Unidentified Analyst

XX.X% Macrophage are not property us. the Last are of the property I conflict you'll under does cause say sure control control we of does, Therapeutics, rights, the Navidea under the those of to owns Navidea intellectual The it that the therapeutics they board and it tell intellectual question, hope if any rights directors? Or the I'm of who?

Jed Latkin

Mike. I appreciate the question,

there saying some juncture, other, legal are I'm legal assertions other. one post discussions obviously belief saying individuals we assertions thing outcome. the there assertions make of Our defer other but question I are obvious the not to that. this for going way would is people's as I'm one well. leave other or -- I but and have just I'm the that their out that that or that leave would at

Unidentified Analyst

Xb Okay. Well, congratulations and moving on forward. the

Jed Latkin

Mike. it. Thanks. appreciate Thank you, I

Operator

private a from [ph] investor. We question Scott have another who is

Unidentified Analyst

Hi, Jed. How are you doing?

Jed Latkin

Well, you doing? Scott. How thank are you,

Unidentified Analyst

we through you in biomarker or X it the on I or is approval hey, fine. biomarker. trials Phase What specific Do have like the that, Phase I I'm Oh, regards X? I to a got got getting this guess confused. the It's little go 'Okay, biomarker what and of is to question. validated? X a a process Thanks. the quick guess I'm

start to we and it it revenues it.' sell so Now and receiving and take can from market so to

Jed Latkin

have both CDXXX will working bit with and because my because FDA turn my the can us that we actively group I that or been say get little to to a Bill? over validated. the regulatory guys set this Mike up clinical they that more to handle with

Michael Rosol

Bill it hear can Yes. any whack wrap great and me? take Mike event, you a up. question. I'll Rosol. It's Can In then

they bringing I'm clinical example give the as and and their own said and registration. do relative But validation pharma as them us kind that a case as to And a think implementing consider the weight event, you trial in what the registration to talk then would referring adds for worse. might that support recognition of by not I'm that's I've literature, Because something trials you and I have the the careful says that's of that the means specialized or that's We in going this and different terminology. evidence FDA might we'd gravitas It parts their will for about a validation due validation, FDA along sufficient at you about is we the get satisfying Phase well and There's yet validation registered in don't have think to of Jed the used handful what biomarker for of process means and to data. to biomarker thing them something. using look validation have a go the this it In you're mean any of will. to at only enable to certain cases informative to X meaning road would of a give forward. thinking pharma of FDA if data that necessarily a of for you're as make of what biomarker. to be about course, the might diligence Maybe be it registrable. us those registration to think

registration. a our have our what bring to case with a Here of in read is the basis that, to can what says, considered It's said we're to bring are FDA the FDA, a deal. specific these set 'Hey, on body things not together is evidence like in that news case-by-case often of get order we out you where Having imaging off bear. is trials the needed check of things data The that the good you really is Xb running studies that this looks like. bunch Phase there's

pap the histal We the it we're says. doing non-invasively. align what is well very but [ph] pap with Here histal

for you this Now, then specific the in overuse Phase register. data The will to to short it consider is us it these you with it that do case? two agree us do FDA, used in is evidence that a in process then Phase help to version something them they for some this we necessary go phrase as and FDA Xb, to accumulate our getting is final as of would of case?' all Is say of to this in biomarker we've accumulated Xb this this our you again case, registered

is benefit. enabling this is and that now if and in looking the be as not to registration and ducks class a up I value used in date, Critical what it's idea pharma In of enrollment help enable trial that, pharma enrich we're from of imaging as our do with might sample bucket from Going studies, they've felt doing reduce for all way this we're help we're Institute. preparing lot maybe their discussions the any putting their we're their defining size. our getting to an exactly trial compounds them used we're brings We would document a biomarker general. for it to enrich enrollment same this we're a decide study by of them is benefit versus Path patient now, It in said, and mentioned, what the process case it row, is and you the with think to would

with what in terms a Bill, and as discussing kind this.' our studies, what We of doing able do do basically and we to that a we have little is We're to as writing in it some data specified, to process. saying, So are little anything the my to my that you with have forward, go you of ball guys general going that In data on kind to must forward narrative bit data the them path it and literature, the differently understanding might of we're amounts strongly. -- in the add is we there's We of these it This But know see it's and is bit the 'This think' institute of thing.' Phase be what keep to make data. Xb -- we want should with necessary have room. to accumulating a them think wiggle these we'll application We'll agree you. Xb all data the gathered things room small data the more and that? what support Phase of of up is they that. the about what go, study bad give a and is in to clinical most is and wiggle the we 'This say, not the wrap case to from they'll want 'Okay, grant news move and there's from CDXXX you preparing opinion of a posted It's we in there's also sense. beauty get we're is supporting not Bill a

Bill Regan

Yes.

designation our FDA it add case, the biomarker. for basically we upon points and lot good that that as to used. we biomarker the data said, of collecting with data housekeeping have with you're qualification just to going for a provide That of the they clinical we're and the likely companies with for seal thing going to of the into obligated to not obviously, at couple study. FDA could do But clinical use FDA want actually they're a compelling it use data the we approval and qualification our that biomarker the in have list studies as product on are particular the data to by of me of good that's here. based be incorporate It's unless we're looking not FDA. other have because It's in have actually some make Let lot has a gave a a I who's incorporate before of actually Qualification we an now is companies it confirm context lot about you pharma that, in terms with the of that on any by to biomarker said, our what Mike their a formal of good ultimate use working biomarker this a mentioned qualification pharma biomarker and -- advice. institute they're clinical us the the -- have our institute see They could in studies. giving their just advice us that

Unidentified Analyst

is not he submit now to data to it enough lacking thing So pharma big that there's use? only for you're right biomarker

Bill Regan

That context the of them studies. Yes. use to We with to accept a use their need share data be big step. to have of to a would the get pharmas one biomarker clinical in

to can which on get the get of by that context time. can use a context one get will one you go based use, you for qualification more ultimate a but the and it FDA want The qualification again would you is second and like upon get at designation step it of than

Unidentified Analyst

the is What that like of something time is frame getting What that? time qualification? the on frame

Bill Regan

decision. then process specified they the It times and the from I time acceptance of are six months of of acceptance after with probably submission the seek the intent to submission one-year make a is to nine-month There time to the it's a for [indiscernible] specified for acceptance. qualification. after that have start the and believe

Unidentified Analyst

looking RA, with are the to pharma big for what go diseases guys biomarker? to other you besides And

Bill Regan

is It that process. is would That about disease-specific. thing it is inflammatory an be the seeking. but would we RA one be necessarily inflammatory really a biomarker

if RA, make could disease in be be state, potentially that tracking if case regardless would other that we the diseases. use CDXXX data in of we'll of Our able to we're then types inflammatory but process,

Jed Latkin

on the to prove And also product beginning also the the we've that and using the several had last cardiovascular, to the more discussions setting. as importantly cancer RA, but since defers months conditions of as had over in year, we've the discussions alluded I inflammatory

body's to going able can't that year the If to the have the instrumental get very, by treatment. the effective as our and treatment use is efficacious the And liver-met force to how universities last tumor hot medicine know of [indiscernible] marker it's the microenvironment be. companies, as So and was the had very that our an area out is to figure microenvironment of part to cam immunotherapies through is that unique field be to if through very, the NX to image difficult image year best because that you pharmaceutical going an microenvironment, force good our want very something have with be tumor is denomination going a continue on tumor. to tumor evidenced the able and can used because tumor, a ability be very being the part the by the tumor the our [ph]. a of still protects of to can't get field, doesn't you body we've there organizations system pitch discussions product a very be with both the 'force field' And get protected research the get it's what and that immune sense we of other really is

exactly of on and show treatments going or tumor trials to will not get potentially these the in which imaging and to some push we're agent what could could to exactly work. the hoping help Our what's microenvironment

So to we're that's a the hope the very big to soon of more show that area these and have some and really an compelling we as with that generating. involved some more meetings that's get data as of we area get data

Unidentified Analyst

as should technology guys the That's doors your little these biomarker, frustrating guess beating my question. guess. I have, you down a a people that for be because it's it using I

Jed Latkin

trial are remember, this pathology is, it's as things so because tool there It and drug we to is think show trials that up that I a blinded most but that not going continue used we be importantly patient-screening for actually different are more I who's One, lots images and as I effective that within trial. you, not. Scott as to the backs But data, data, getting have. during with be the you're a never and of could something think the the agree

pathology and make showing be case So able then get bring partnerships showed we what in do think a be some data revenues some images, that and the in we're on space. the more seen to compelling what we've once fact is and to you able in we will

Unidentified Analyst

Thanks your Congratulations Okay, progress, for great. on taking call. my guys.

Jed Latkin

Thank you.

Operator

Would this a like At are closing time remark? further questions. no have there you to

Jed Latkin

encourage I the guys the look Thank speaking future. everybody to I the Jerry. thank today. with calling and just forward I you, website want to in look to new for to you you in presentation. Excellent. go at

be will the at weeks. night. forward be some many a upcoming We speaking and have upcoming I over of presenting look great with Thanks again conferences, to and you

Operator

teleconference. today's concludes This

disconnect You lines at your for may your time. evening. this Thank you a have good and participation

Jed Latkin

Thank you.

Navidea Biopharmaceuticals (NAVB) 9 May 192019 Q1 Earnings call transcript