NAVB - Earnings call transcript Q2 2019 | Navidea Biopharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings, and welcome to the Navidea Biopharmaceuticals’ Q2 2019 Earnings Conference Call. At this time, all participants are in a 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, Jed Latkin, CEO. ahead. go Please

Jed Latkin

results welcome, a Call. and Navidea Navidea’s Quarter for XX, of and Second This which remainder quarter Good on the of ended Jed everyone, goals Latkin, Earnings June operating financial Navidea’s I’m will along of the Chief XXXX second call XXXX, with afternoon XXXX, cover to for discussion Executive XXXX. Biopharmaceuticals. milestones Officer and

a we remarks, open the question-and-answer will session. to Following our prepared conference up call

call the Erika on With our Chief Director Officer, Administration, today me Rosol. and Finance is Gibson; Medical of our and Dr. Mike

Before XXE would considered Securities XXXX as that this everyone we of statements formal begin statements call Act of conference our meaning materially remarks, Exchange of forward-looking could like to on or uncertainties XXA the those of and I within XXXX remind amended Act be involve concern may differ the the that some projected That the Section and statements. Securities to of from matters results Section amended. as forward-looking risks in anticipated cause actual of

rheumatoid such of diagnostic as cancer, plans, company’s statements believes, the for to potential, ability effectiveness develop and of estimates, optimistic, commercialize These bodily arthritis. company’s similar of aims, suggests, well diagnosis forward-looking relate expects, intends, and Words seeks, goal, forward-looking expressions detection successfully and such the targets, tests, identify anticipates, as and fluid-based early the as statements. platforms to the monitoring test

results to actual may from indicated due numerous company’s The uncertainties. statements materially these and those in differ risks forward-looking

the risks company clinical intended development and and or execute the diagnostics by develop inability to risks the to products market; company in face our internal operation. to its our company’s may due other most the outcome accept marketplace Exchange, the become fierce the products Report of technological XX-K products clearances might Form rapid the obsolete listing reporting, the XX-Q, obtain the inability may maintain any if any products, with York identified the the Exchange Quarterly recent well unable fail and diagnostic develop; competitive in change; financial company’s with pipeline Stock New company’s to in company maintain market effective will documents Commission. the we Annual competition other distribute the necessary failure to Reports Other nature products on and to a that market to approvals instance, company’s files future IVD regulatory diagnostic of commercialize and failure litigation, over or as we control Form as For and and other of highly Securities uncertainties include and pending the on plan be to

company’s are These of risks, statements assumptions involve to expectation, are guarantees based, predict. in projections and uncertainties management. on about not business current by estimates and and based These on statements the that performance future assumptions made part, difficult are

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

brief a with business I start would now introduction. like to

to the once a off, in brief quarter Q&A First longer will this afterwards. order allow comments relatively be again session for

Jersey. the Firstly, our today Board like attended Annual and thank I Meeting Newark, that shareholders to members in would earlier New all

proprietary made our condition progress forward. the closer to also but for we bringing very significant As look the the our of emphasize strides back only need financial we’ve made RA the towards, on not company’s agent path some imaging quarter, has towards we last to that company stabilizing realization,

to given we our necessary coming interim This warrants, specifically, raised look quarter. in million to equity more any in $X used milestone, has next capital the us get past financing next quarter, the successfully being in without the which

announce to the develop our on laser-focused also further this possibly an revenue grant notice like largest we have help potential this promise of will that intent one of company. and imaging sources While the remains atherosclerosis, for a fund given team future that to clinical of the trial, on week, of NAVX-XX the been would area I great

with we front, partnering continue the to overall work and the in On under both partners few imaging a quite CVA space. RA potential

also the not are We actively approved extension partnered. of new existing our in currently pursuing geographies product

right encouraged a made being the development partnership by Securing We with progress under are a very the goal front. in partner XXXX. for primary the this the the business and turn on is right company feedback

our agree will to agent RA that not We deal hold. a that inherent diagnostic value the reflect doesn’t

clearly would and insurers, Americans the it the healthcare million the very X.X would suffering from nearly what product industry understand disease. debilitating what potential for mean most importantly, healthcare to this our of We and mean

Furthermore, running result actually elaborate are shortly, enrollment of coming once trial schedule. considering proud to that will our it Dr. of partnership. comes this when say is making with interim we ahead to up, like how as the clinical again trial team, Rosol I of would a I’m

initial startup have what have to was the that back up soon our with investor I’m few continues, over interim really weeks. liked, can the While this we look. come I first last hoping not momentum steam would picked and we

on the the I’d Mike? front. over more that, With to to like Dr. development Rosol turn call for details

Michael Rosol

everyone. Thank you, hello, Jed, and

Medicine an in updates We for in had from data June today’s to from extremely always, Society we Imaging participate Molecular provide X call with our I’m Phase and the presented studies. you clinical Meeting and and Nuclear Anaheim, successful in side. where X As happy

joints signal active RA. demonstrated localization X study to active that with study to of patients to signals us to Tilmanocept RA The and window. joints X showed with showed to and the Phase subcutaneous results and allowed we empowered to Tilmanocept, move of intravenously-injected the with Phase This of the Tilmanocept adverse safety patients of see controls injection able with of determine no the dose of localization optimized to healthy compared an imaging were us

rheumatologists in The staff Tilmanocept with is press SNMMI highlight RA. work out obviously, with SNMMI, it us but with session, meeting also were and meeting prestudy by important for field something selected they recognized Medicine the Imaging results an reached onto these the by people Nuclear these and not of us validation solicited have the idea only to by SNMMI, in Research, the their honors. of This neither of about presented and a to was expectations excited and the be The RA. actually Rather, imaging the of and very reinforces release our that potential in was we’re here significant us. external the suffering type recognition exceeded

in of that our you three-arm the order change X is Remember enrollment Tilmanocept stability let upcoming help our our to in patients in running that us study subjects both are to with track indeed validate we aggressive RA. with readout Xb study. and calculations through enable And are Phase two active Phase arms the we in study, Phase happy projections also of third imaging and data healthy on and mirroring first our are power that know the arm, to ahead X. this I’m of for evaluating reproducibility the

date, see our opened on is then subject, expect news and perspective. rate, sites weeks the and several To really recruitment all very XXth from currently acceleration Board the enrolled, just even come an today, stride, learned earlier I more that as four in these and to and good the we sites sites in hit we’ve coming opened their

alignment interim interim in we we into data the these sure we in trial. and to we expect with make Importantly, powering X. Phase plans go back can add built for analysis in still or to are have and this in interim And looks hand, FDA then fall, the the the

are healthy at a inflamed getting at be how of looks with will values joints and how in the we anti-TNF-alpha at is, imaging these the data RA quantification of of readout analyses patients, and kinds subjects changes readout and reproducible our how imaging stable The much include: look robust different between treatment.

X to study, keep this and readout by second as with our for you thank their we to Abbruzzese, later Again, our to of the continue rolling trial for continue sure converse getting clinical Congratulations move situation in of plan We’ll of Bonnie year. apprised the projections. led be them. and recruitment to we Phase with all histopathology the the want and trial operations correlation work this imaging FDA. exceeding diligent to team, ahead Phase I Xb

extremely other areas in our commercialization, those is where RA simply and a items moving want the registration an to actively of on If what coming anything interest I the on and Because just our to research appropriate program, it call. is focus going touch we leave I on focused FDA projects pipeline. overview continues program briefly an to that of maintaining of RA this of in are give here the out, you few up. While to focus are I’m assure on and you importance

Kaposi UCSF So sarcoma at work continues.

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

we later to early fall. are track On complete the on clinical imaging enrollment this side, summer,

full up, would FDA about up and open the the Following discussion can sNDA analysis with hope wrap Kaposi path we in sarcoma. to we

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

we plaque investigator-initiated ability atherosclerotic Tilmanocept the Dr. discussing next are actively detect with additional We is to step plaques to them. the this continuing subjects study Grinspoon macrophages. is enriched General look there of have imaging also and at Massachusetts at recruiting to ongoing atherosclerotic Hospital. study with activated He run

in the compared has very as from and Tilmanocept Plaques with Phase collaboration deficiencies widely Tilmanocept. macrophages a of happy plaques, application but Tilmanocept studied PET pipeline with and of test looking intent imaging at also allow received significant will fund Gallium that in formal submitted pet NHLBI, test have comparison one agent PET believe that notification to FDG we XX the in method a X us mouse I’m relevant Alabama to grant of NIH fits which to and model, announce to atherosclerosis our and in of University a we Imaging to to imaging, our Atherosclerosis

for for formal collaborators this news. Committee’s Alabama are to congratulate shortly. Animal fund several our to point, which supporting is Director that intent with submit us [indiscernible] convert like the Drug remain Ralph, at on And only expect see And document noticeable Dave Development, is a that award to from now approval of And grant remains Welfare that the great So to do I’d the to in is at to materials. we UAB. University of what working Senior Birmingham, to

in handful Phase imaged Tilmanocept with will PI patients have the reviewing best with pilot results Zaske] [Mike we determining been Gallium of this the the of to first The study with XX and how South Africa, there, of and [ph] TB be proceed. soon

discuss possible more with expand space. that portfolio provisional radio year. we filed We’re patents imaging pharmaceutical this this and IP mentioned, in several companies to with partnerships also And way continuing our Jed distribution and to the and CLOs collaborations continue as companies, pharma on play

a summary, in RA our towards schedule. as into Xb main Phase So moving first on focus clinical our Enrollment product. is and a remains ahead of approval

for continue prepare plan X. We the to and Phase

preclinical ahead in of success to We’re Thank also our clinical from other research push securing and continuing and pipeline support NIH. continue to you. areas in in have

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

Jed Latkin

and forward. ball Mike, that for Thanks, thanks summary. moving the Keep

the updates. onto move let’s Now Erika? financial

Erika Gibson

Thank you, Jed.

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

statements reverse stock were the by consolidated flows of not cash split. impacted Our

XXXX six $XXX,XXX XXXX XXXX. months of that quarter with to the to of background, were compared for $XXX,XXX period revenues $XXX,XXX, the compared revenues for as $XXX,XXX, in So of XXXX. first were second in Total total same the

revenue non-refundable to revenue a license technology, in grants SBIR to primarily decrease NIH The to XXXX, was NAVXXXX a which upfront related decrease sublicense from coupled Manocept in due development. supporting grant our with the included of payment the reduction in related a

second period in and compared million the quarters expenses of of six XXXX to $X.X approximately XXXX. $X.X R&D XXXX $X.X in first were expenses were the XXXX. for R&D of the months same million, of million each

development offset R&D by included to including net in TcXXm due expenses and drug in Manocept salaries NAVXXXX project diagnostic The development headcount. year-to-date also primarily compensation net decrease and decreased costs. increased costs net was costs, tilmanocept, expenses, The decreased decrease resulting decreases from therapeutics,

approximately six were of quarter million general million, XXXX decreased and second and XXXX. million expenses Increased to each compared were of by the $X.X period services SG&A were first same $X.X compensation the of of Selling, and in for $X.X administrative legal professional XXXX. months expenses the in costs. XXXX offset

per stockholders attributable to to common or period share, common million, was to net Navidea’s for quarter of in or the of attributable loss for stockholders loss per $X.XX a the net share, XXXX. million, $X.X second $X.XX $X.X compared XXXX same

months or for attributable period share six net XXXX loss per a in net stockholders $X.X of or loss compared Our to million, XXXX. was to same for $X.XX first $X.X per share, $X.XX million, of the common the

Navidea of million finally, cash And XXXX ended quarter and the $X.X investments. with in second

back that, Jed. with turn to And I’ll over the call

Jed Latkin

is Thank trying Okay. all There afternoon. this promise to do a you here. we’re for great really in joining what us

about quarter the message I really of or that you to We’re excited excited what to – that the hope today. look lot in a conveyed X-XX within like effectively and so. trial, is I the interim look developments the next going we’ve to see also

to I questions. for up open like now line would the

for please So let’s you give questions? Can to queue up Sashua. it over

Operator

first Certainly. question Jason conducting Instructions] We’ll McCarthy session. is [Operator now ahead. of from be a Group. The Maxim go Please question-and-answer

Jason McCarthy

congrats the question the taking progress. for thanks guys, and Hey, on

Jed Latkin

you. Thank

Jason McCarthy

from see data the and from you could could trial, anticipating the in Phase us not its a own whether what XX I’d X, So, to or if color FDA timelines, we approval? third-arm as size, the sufficient on expect give seek be trial on terms like of you’re bit to will we’re Xb endpoints, Phase approaching more that

Michael Rosol

question. Good Yes.

Mike Rosol. So this is

running the assumptions to confirm to XXX is on those currently let based we X So for Phase need NAVX-XX know inflate now subjects. arm us of some The verify, the right if us projected degree. pilot or will our numbers help size the

successfully. goal in QX that trial the FDA. that be with have And and the to should And that to with running have level trial to the would – in, all everything at and towards in initiation the of XXX, that – enrollment then the of go it is the recruitment completed begin QX, goal our is the NDA XXXX

Jason McCarthy

you. it you’re for in an be sense spaces with the for the looking what in partnership general? then of a like more It’s RA looking a would a would partner in you kind because for in sales side, diagnostic medicine, more you space of make an partner Thank give to different me here. right. could And if All you’re actually nuclear I’d few in force go a established just on like imaging bit idea the across space, Tilmanocept, for or of going someone to see

Jed Latkin

Jason, good that’s a question.

So we’re both at looking actually. currently

We’re in companies already are looking at RA the that space.

to some arthritis but have not of rheumatologists. larger So But we’re they the have looking funds have the who throughout network diagnostic there. rheumatoid also now, space to necessary the players, the distribution the might at right any exposure get

we that, not they up they a platform, It’s we with important up that when hit do launched along this have Lymphoseek, take like partner we have it muscle, force even to what force the don’t sales the RA a something we’re is has really What we going build look to if to – built at financial juncture. that’s had client-established to RA sales an that rheumatologists. would find all and do

all larger be backing talking all the of presence and can amongst they to enough build build financial sales able are a and assure a diagnostic of up we’re force that do have people enough the rheumatologists. that the a up will presence players I that you to But that

Jason McCarthy

All one don’t right. you. if you me Thank for more mind. And guys then

are no new So buzz one to the the longer for in of noticing we’ve the bit around I patients JAK TNF space a mean, specifically RA inhibitors drugs. drugs, things who a anti-inflammatory of there’s responding been

you of my for like expecting impact is, presence PCTEL? question the newer need later are this So to the drugs how class something of

Michael Rosol

is This Mike. Hello.

comment So there things the to several on – are here.

recruitment types new the work that, macrophage well They as inhibit to in inhibitors, pipeline. promotion JAK that therapeutics some of to are there anti-GM-CSF macrophages. activity other are of as indeed, and agents the So,

we’ll question. let these this some answer So garner to and kind indications of me then broadly of really – your

patient the, Some what not if the of these stimulating would therapeutics, would those. the imaging in determining on factor our a example, of impact of indications readout fit have exactly we so, provides, or wheelhouse the And anti-macrophage though, significant benefit right? kind from for could

space, imaging we’re can RA an potentially them going Phase in determine to subtype indications even has. our that help JAK give readout of that in the is towards broadly, patient the the one point the that of or More for X

you the and discussions are of and [indiscernible] So those them you – three some given involvement. RA information of different subtypes of macrophage might myeloid might are of you, myeloid have levels that two and from there earlier the we’ve macrophaged and enriched, recall have

And all. then the third are types type, the at – involve macrophages don’t much fibroid

be baseline, that scan macrophages, actually able our to fibroid subtype, those on with the focusing might at folks so, are us on And who it be right? our readout – of have information should give who that the

from So a the learn if and not, That might this may that other with a if this the anti-TNF-alpha. won’t or study of back globe. these the That we’ll arthritis of JAK some from folks control subtype those indeed benefit subtype. across patients then inhibitors may the through subtype or our relatively subtype course benefit third true like be the of scan be looks rheumatoid healthy the is ones. about And

right simple we other something that very initially, could have to the if they JAK all question folks So anti-TNF-alpha, holds the which are going that it the inhibitors of unlikely one and true, than footprint point of then those answer a and is heavy others kind your else do near those to have upset to there could that future. a in – the game, we in

to some reason with forward, and know, we’ll because is with going move might to right. XX% path, there the you started along as trials change. other And you first way indications think specific point. indications at will we’d expect And are we world actually our drugs across likely of towards those other different the we anti-TNF-alpha, The into play, related as RA to lead the we days [indiscernible] help look So expand come indeed, through that with of go folks therapeutics. as

patients right As you I said, away. the a third of might

scan say, after than “Hey, anti-TNF-alpha. bucket those imaging So and our put those something other on

in discussion, kinds pharma it’s we the already. them our kinds agent of revealing to much, those our because imaging are companies the So therapeutics, without multiple These have are in on things too it discuss, if at benefit ways company. but would different of invested

Jason McCarthy

Thank right. helpful. All Yes. very That’s you.

Michael Rosol

Yes.

Jed Latkin

Yes.

Operator

Drew The go Please is [ph], Rick from ahead. a next private question investor.

Unidentified Analyst

as at the Erika, for the is in, want of to based fund if is present, long how the This on burn relative Erika, runway hand, you to cash and pipe June Jed, to on XX cash course. of operations?

Erika Gibson

Yes.

Jed Latkin

that. take I’ll Rick,

So the we’re with little we’re I upfront think partnerships to we as based potential as that our end probably possible, in. make coming that last to are depending on how potential getting can what us we payments looking the on the bit adjust further, the cash to adjust to as doing, on and cash year, maybe partnerships sort about have spending hand, what we will make. of of in, we prepared we we would whatever But long make sure a look bring the

Unidentified Analyst

at past, done future. the do is are as able come – expect of have – that you quite if have to in play I you to Well, Relative plans, that there that the forward, operations funding well, partnership said in going certainly be time? to doesn’t partnership alternate the this into and the

Michael Rosol

Yes.

us or would how stand case, looks would And expectations. exploring as that and up trials that options with just think whether lead that of funded. think next the drug the now all terms is it progressing that’ll other if I where sense interim then we is several options I over to is much potentially our a better well. and RA keep mean, months, the right progress to business coming sure make of that we in the of meeting We anticipate the can give the are I we not the

Unidentified Analyst

a maybe partnerships of too not Last recognizing some in less pursuing Okay, distant distant internationally upfront that not question. got future I’m if you than it. getting international terms even from any too type realizing not moneys, in an than perspective, guys being year? of in shining partnerships – are more the any sales light other

Jed Latkin

Well, good point. that’s a

we if add did So as my you’ve – that. noticed remarks, in

are are partnership. pursuing of covered use the We Lymphoseek the of that actively current expansion countries on the not in

are the contract. we not are regions discussions by So say, either in emerging cynical, active covered that or in several

that So is potential. a

Unidentified Analyst

Okay.

Jed Latkin

hope within can And and we report or have that the something on next to two. – hopefully, quarter

Unidentified Analyst

fantastic. question taking in my Good there, that’s Thank Jed. Well, for luck regard. that you

Jed Latkin

Thank you, Rick.

Operator

Russell next investor. private Mike [ph], ahead. Please is question from a go The

Unidentified Analyst

thanks Yes. Jed, and have question. them of several taking Erika, for Mike my here. I

were any one relates marketing first two those Zealand into approved Lymphoseek New a discussing, I in that could down along Are and a that The provide to little on noticed is medical you marketing countries. agencies topic funding? something agreement that the upfront last potential potential Australia countries more agreements. those drilling moving some

Erika Gibson

No.

are license. So under Australia Zealand and Norgine New actually covered the

we’ve the Norgine, so working And you it can launch so with Australia, them start selling in product been getting there. on

Unidentified Analyst

Okay.

would So current under it the the agreement? current be of terms

Erika Gibson

included Those – Norgine. of The under are and Norgine’s Europe. that agreement the part is in world

Unidentified Analyst

year you’ve certain NIH submit Previously, there grants additional mentioned now? working right anymore needs that in earlier a working you NIH applications. Is to grants of Okay. and the number were on

Jed Latkin

Yes.

now we’ll I right that that still plan information We have that’s category UCSF they notice we do and of the the two funded. intensive submit round just-in-time, we the get the we – this final said another to get Once that call we have well. in in, award. We supplementary of to we fund as next those have go into need that that that transition grant at So running. once application

Unidentified Analyst

in Dr. forward in clinical Lymphoseek. over couple other was Okay, And of mesangial diabetic both you suggested using moving two in the [ph] kidney was using studies and neuroinflammation. Vieira, cells studies years published into Tilmanocept/Lymphoseek. last had One the

those guys giving moving the trials? clinical anybody as in and with know, he’s you working those forward, or you with do working, he As

Jed Latkin

in still neuroinflammation of And be kidneys. discussions are all had the there there. the to to Yes, on the then above

tilmanocept not story. crosses necessarily of one convincing for is the the And me the evidence – the isn’t intact barrier. thing, at the So end to that that least blood-brain that

well we’re to to have if move space, we that into going discussions with need further So – David. certainly

obvious reasons and affiliated for very closely with frequently. We’re speak with him quite and we him

are so well indeed, include space seeking funds. kidney there the NIH also as And do in plans and those

Unidentified Analyst

So in saying kidney, you’re neuroinflammation… on works yes, in there something’s the the

Jed Latkin

Yes.

Unidentified Analyst

so sure …not right now?

Jed Latkin

maybe. Yes,

Unidentified Analyst

some in that being on cardiovascular from treat I’ve where you’re read RA cardiovascular real therapeutic Europe, not having effect able Are Are your the your events? out carryover you reports Okay. seeing preclinical in trial, a to a you studies? effect even RA of – is duplicative seeing recently sonnet? positive though or on doing

Jed Latkin

No.

Unidentified Analyst

Europe? …that came out of

Jed Latkin

Yes, you. I hear

it the So model turns a model if want RA. out way you work RA, that induce is in the things of usually, preclinical you stage, of right? So this, the

response are So mimics creates there’s do there and and different an an that. ways basically, inject inflammatory you to people. allergen, RA immune But response, it one that

So like the typically And kind those are human take and have some stacking – could way the done do atherosclerosis RA They done those or mice, you to unless either models are mice, argue it not mice for we them something good where pretty are are It’s induce models are maybe in for be also more. knockout models atherosclerosis of studies. that. specific. infrequently, that should to to you that’s

– any So model for used unlikely example, mice in are and so usually, on mice, therapeutic a to – won’t if done And cardiovascular those going It there space, to we’ve for speak. because good in atherosclerosis, know wasn’t even the not in as that something going have being we’re we wasn’t to that space, purpose. what’s the for model that. be

fact, doesn’t it’s since but no, a that evidence of high-level, me, So suggesting sense, macrophage-driven there’s at growing So a in disease heavily – surprise it if body atherosclerosis there’s growing process. and since right? a macrophages, involved, in you’re –

phenotype are have or effect from sense positively one other that diseases you perfect macrophages makes of the effect as or disease, to the to them another, and one you down well. treating If a nodder kind knocking cascade it changing macrophage-related me would

yes. So,

Unidentified Analyst

they into CV General group. XXXX. they that into the us give in collaborator, AIDS a you studies Okay. into very Harvard that, added you That last also more their on And see leads the extended studies positive Hospital if patients. step? noticed AIDS on color I Massachusetts as Can their update,

Jed Latkin

definitely Yes, that’s positive.

folks. did reason. more obviously for in So to we that enrolling, touch that can Tilmanocept in atherosclerosis. are expanding. a they with make we want to We – accumulate how – might strong so those we’re be a continue case for And they data They’re used

the so far so frankly, we. they’ve pretty bullish And so achieved going now that right on and, they’re on that are are results

and but involve Now a a a modality therapeutic diagnostic in a space of over them be, even because and to in and of or studies follow in need opportunity, you people giant it’s atherosclerosis to is to large to play be of to course averted, need numbers years imaging these tough the right? be terms tend what order may see outcomes may space,

high-dose sensitive to side folks plaque real an imaging readout have the a that is risk need atherosclerotic it’s doesn’t would stat. therapeutic So there’s a detection in maybe – domain, as that the be well quite all road the but that in can who a whole, a moderate giant of are And opportunity. as for effects

studies road, we’re the get diagnostic domain. of pretty But to take with the FDA-approved So it’s a to them, about but and going and to so these MGH therapeutic. us an very [indiscernible]. and/or are It’ll sometime is end promising excited there Steven on

so And directly. with Steven affiliated bringing details but I know if indirectly, is the AIDS likely the the Harvard that of nitty-gritty don’t that fact Institute, in not

using HIV to And that so, may help them positive he recruit folks. be more

Unidentified Analyst

Yes.

back with FDA registration to you. Okay. with you’ve give the biomarker working on Can goes last process? this my Thank All registration on? right. them that that question, been the us and you And any update

Jed Latkin

Sure.

Unidentified Analyst

at? you’re where And

Jed Latkin

Yes.

myself. words misuse this made I’ve So of

to no, you So do the and biomarker. out for the here, And not all registration straightening me that just I qualification, as a me well, it’s it’s reminder time.

and get an letter Path to document, continuing it’s have folks, what that it supporting should be the working regular that outline all file, a are crafting our with of think Critical are large and It’s accumulate it’s the where fighting we we’re qualification should a this we what with it have intent. our can us we we updating be, the there. And relatively our indication, is, – application. So and we of basically a we data our almost where or to meetings those Institute And we’re either document. cover, going what

from Xb I the the imaging though, that it results, order to in number last Phase Now second the say pathology. call, line, to macrophages I – we’re the density, mentioned correlating the goal and our where do CDXXX have over going we’re in Phase to CDXXX get with readout need on study

read. So – we’ll final over that be the our have get dotting boutiques that’s crossing And line, to the the the that’ll be actual qualification day the correlate us – pathology think. imaging with that’ll I of to IV

are those to and want the that’s is might pushing a live reason you. I with it And of giant letter, sound, It’s basically letter the we thing a you a one of don’t intent way folks page letter I But document. to that forward. grant intent application. a continuing for said to that think

gives qualification, You need proceeding. is about – where a the say, chance is you it case what are feedback to and get And we’re go they you FDA you fosters and to really it where why. about and but for the it this that is what this to it give think going

to starting a about to back example, Phase And it, X. know The the by be we we the discussions, while do know – – the will But way, I think Phase to little believe after – get question for when second can be the X trials endpoint this sure. helpful ago, for FDA for you for pharma registrable this X, we’re companies, looking And a will who this month. is we never would register? for enough do – the I’ll earlier Phase that we you was asked in get the are with in

We’ve design had is communications it have belief Phase approval. sufficient been positive, to into will And with the the that they FDA we be for if has should our and as that X goal they of, FDA. agreed get principle if proposed the line over that that our the

we we’re And X change is them goal going Now far, that, you get where asking this or to the to stand reserve us that. their another right minds Phase first in need and to they said that we having X. keep do the that always think will to Phase But so say, line.

you to back Mike. So

Unidentified Analyst

there by asked. that, in there’s you participants. clarification before a appreciated it your gentleman Well, But XXX was said,

roughly you were Jed at – current XX. Your said,

and difference the the of the the study, the or that Xb XXX the between arm is is third basically, XX X? So Phase

Jed Latkin

No.

So things. different that’s two

three because It So those the currently The analysis arms of be it running might to XXX. arms. Phase of actually all has Xb be is three the less, – enrollment going the interim the two theory, In interim first that control the and and active arm at is RA arms, we healthy three. the recruitment analysis. focus significant typically just on stop the could of total

arm. but arm folks and, the we That’s So three arms XX as longer in the three in – a well. participation the indeed, sites arm a accumulate duration, that that right to, binds pushing the to is trial now that longer in in there’s to we’re the folks in trial. to objective recruit and the XXX have there they’re subjects are up – And mostly

Board number are a coming specifically. active about super-duper arm, on jazzed have that We of sites that

to a picking the explode arm last sites So we couple of be started other enrollment the of out. came going nuance small could because soon. And from anticipate weeks, is has in general up already couple really you had large awaken. in have to the enrollment worked a that up has in vacations we large, and to if And that people started back nuances been some opened and that

in the trial. recruitment actually, about and improvement And going so is it’s really happy that I’m

is the of pilot total the we’re one like subjects. arm, Phase In arm of that that And pilot, XXX. a has that NAVX-XX, looks the like that XXX. pilot looks do XX looking arm three for of the The X that X or Phase has not

in So the XXX the X. pilot XX Phase in arm, Makes sense?

Unidentified Analyst

will they somewhat this run X-XX, as And in right? – along everything long concurrently moves moves as around

Jed Latkin

Exactly. Yes.

Unidentified Analyst

chance have glad observation a right. as you guys things. appreciate All hope into you take at this. – I And into one. for avenue to, private because not I’m Well, do doing of these good rushing joint whatever one, have jump shareholder, my sake a sure I one not the you own Okay. venture for you I only get is, are partnership a

share I you. Thank are appreciate vacillating even I tolerant significantly. the your with the price And patience. hope shareholders So

Jed Latkin

you so much. All right. Excellent, Mike. Thank

Michael Rosol

you. Thank

Operator

ahead. next The Please Joe a is question go Ski, private investor. from [ph]

Unidentified Analyst

just – please? are about was wondering where we can about Yes. talk And I that, you can the litigation with we CRG.

Jed Latkin

question. Okay, gotcha. a That’s good

brief court So in and front get currently judge back the in we’re decision the for Ohio to for Ohio, CRG, summary to we’ve in appear submitted of a in judgment terms waiting in of we us or again. might when

on right that’s So now. we’re waiting what

Unidentified Analyst

from about any exchange? there Is the Okay. talk delisting

Jed Latkin

exchange weekly the No, a on we basis. with work

them. currently So talking we’re with

with in And our so So show an to we’re we We them prepare are the and are we that the around have clearance February we compliance. full having dialogue active make we now, them. until for – plans. a timeframe sure projections,

terms working next very They’ve we’ve them still projection our them of to been what plan. shown with we’re several our we in they’ve the expect – over showed helpful So and quarters. see

we’re far, okay. so And

Unidentified Analyst

said Okay, great. till they you XXXX? said, And February,

Jed Latkin

Yes.

and working So more fulsome everything end is on the of we another at them, still we’re update February for have with now, But that. okay.

those presented all them and projections to accepted. We meeting. have We’re been

And so be we deliver, as long continue we’ll to okay. as can

Unidentified Analyst

intro. Okay, great. Thanks for the Thanks.

Jed Latkin

No problem, Joe.

Operator

There time. this Latkin turn are I for Jed floor further questions closing like to over at to would the back comments. no

Jed Latkin

I for everybody day. a mid-summer just thank in calling to on want

you, and everybody. all of the from again, appreciate very to So I look soon. updating I questions forward guys, comments

hopefully, coming a there. catalyst be going in then some And be next couple of of on and the big be interim look We to forward release a in look press to bunch months. are which up, the will the we conferences presenting will Those company issue September. in for somewhere should I

Operator

teleconference. today’s concludes This

participation. lines Thank at your for time. you your disconnect this may You

Jed Latkin

Thank you.

Navidea Biopharmaceuticals (NAVB) 8 Aug 192019 Q2 Earnings call transcript