PSTV - Earnings call transcript Q3 2020

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

Operator

Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Third Quarter 2020 Earnings Results Call. At this time, all participants have been placed in a listen-only mode and the floor will open for your questions following the presentation. [Operator Instructions] And before we begin, we want to advise you that, over the course of this call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risk and uncertainties, including the risk and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. to risk you such in advises statements. Therapeutics review factors these considering Plus no or the to statements Therapeutics responsibility Plus assumes update made. events, or are to trends revise circumstances they after date reflect forward-looking any It is the to Dr. to floor over my now pleasure turn Plus Hedrick, and Therapeutics Executive President Officer. Marc Chief Sir, you begin. may

Marc Hedrick

our thank Thank as business a we and taking XXXX quarter time you discuss results. third Catherine. you, afternoon, to the provide update for Good join today, and us

Sims, our call the me Andrew is Joining Financial today Chief Mr. on Officer.

Andrew treatment. [Technical a recur Difficulty] only financial aspects clinical aggregate all of in Before second, used There the currently affecting tumors setting, the Recurrent over outcomes has few common [Technical an provide Difficulty] cancer that XX,XXX target brain most therapies. in glioblastoma may about compelling [Technical in performance glioblastoma rationale United potential after and currently patients And RNL States. provide of year approved Difficulty] number recurrent benefit. lethal are is the that treatments primary Essentially it scientific update glioblastoma. on show which indications improved provide form cancer. unique marginal additional survival initial per

the disease in possible it beam that XXx recurrences. the radiation exposure is RNL beam targeted and approach bulk to to in and to with may RNL lead reach out radiation higher nearby tissue more high to and compared the to with attendant only surrounding control be reduce passes up and with tumor radiation administration, to tissue. whereby Also tumor, [indiscernible] to injected radiation not doctors visualized therapy. through healthy healthy than Rhenium RNL the form dose real-time liquid better can external the a dose be external during treat distribution First, radiation tumor. RNL radiation tumor. in the effects inside This energy but XXx to tissue Furthermore, prepared healthy deliver may rise therapy, the also is microscopic drug because unwanted into may fuels effectively

We or tolerated pre-clinical our to maximum studies. have determine the yet in dose clinical

XX drug time addition, long clearance the time for In a liposomal a to allows rate, cancer-killing namely the encapsulation it's low the state pharmacokinetic on RNL's hours, applied maximizing profile effects. radiation long half-life, theoretically and of where tumor and the maximizing with about

radiation of convenience, a patient Finally, more XX single-treatment stay is hospital or require course. may a terms in therapeutic visits short treatment in beam and full administered therapy RNL compared to the that external for

advancing the experience as neuro-oncology, is of patients pleased profile group, we RNL's important company's five of Board be fields help the the support end, the in drug behalf announce bringing and our well RNL a possess for knowledge with These priorities the are understanding have the successfully as and their and development in a to process. efforts with appreciation One to through clear of that of the potential. operations formation to on neurosurgical and RNL our fields clinical To development expert first surround October, of efforts the in to will and were Clinical leaders experts and glioblastoma. Advisory our who investigational world-class and

and XXXX enrollment, to chains optimization We progress trial milestones making supply the and forward the on the including in clinical of standards the of steps anticipation in the good on bringing clinical completion are and important industry plan this track of development. manufacturing for next program, regulatory

both Fast glioblastoma. Orphan designation granted for third for treatment the and quarter, Track the their RNL designation recurrent of patients During FDA with

accommodate the four-and-a-half events far. there should of RNL fifth No Single trials thus tumors approximately appear volume patients efficacy And dose the and increased is setting. is RNL. and adequate been as sixth typical to treated patients in observed RNL. have cohort even dose and tumor have the early recurrences. previously dose up dosing far serious XXx centimeters, recurrent safety The ReSPECT, coverage now majority an to in for at feasibility The should Now, signals treatment-related above which just adverse thus dosage with XX of include tumor been treatment dosing with volume now provide and administered with let on me cohort update escalation the specifically and treatment mentioned, lower in the levels. be the complete radiation

also third to have a intend a enrollment second to expanded site and onboard have We site we soon.

far XXXX abstract Society the to in thus with Finally, our to of on for but regard virtual a the due announced Austin, it's will as meeting held clinical actually company, presented going XXnd, RNL November that's to Neuro-Oncology and by to experience been be at be recently the Annual COVID-XX, XXth Texas. XX

programs outside provide in Regarding to next we and intend an concrete additional recurrent clinical glioblastoma, development steps sometime for RNL, of discuss QX. update

three peritoneal and represent existing based generated potential carcinomatosis, leptomeningeal have cancer data recurrent we head and carcinomatosis As on [ph] far. neck promising that indications pre-clinical previously thus mentioned,

partners discussions it's help Regarding primarily on efforts are company development with our [ph] we activities, us regarding while expand for focus to out-licensing RNL. the RNL opportunities potential having development the internationally, US

its partnering and while on two primarily clinical we in our DocePLUS stage RNL US. and global remaining Regarding other assets, development DoxoPLUS, the discussions, continued focused

a Andrew? review let results. turn financial the me third of over Andrew quarter the now for So to call

Andrew Sims

Thank XXst, compared periods our the summary September months the The December for million $X.X amended million third compared was period approximately of million XXXX. of nine $X.X only quarter and same compared reported additional of revenues and out interest the last same we with $X.X paydown due afternoon, results Marc, contracts no compared debt a of as quarter. operations today and the flexibility in year. by September we the pushing million as was the May September XXXX, financial through both to a you, in press together period for At as million earlier XXXX, of nine BARDA were principal. year. equivalents the There Please mentioned XX, for was decrease the our months $X.X year. April XXXX Cash XXXX, cash quarter XX, third for close of million our to to quarter XXXX, In Oxford, ended was $X quarter million XXXX. everyone. $X.X million, last were XXXX, expenses the ended XX, million. providing release used in good $X.X to last in $X.X to development in out XXXX, third September Research last and issued to third cash period in the to with at Debt refer principal $XX.X

with Approximately completion nine close $X.X same the in million compared in QX The May, September period expenses R&D ended attributed months to the XXXX, $X.X in partly was XXXX. For $X.X contract early to to cash XXXX. $X.X the balance million in million XXXX was BARDA in the was in of decrease relating paid with stock. at in in-license incurred agreement million the NanoTx. the

our covers RNL ReSPECT a addition, from [ph] the on clinical clinical NCI, to costs In grown trial.

the of XX, months and G&A quarter the to were last million same respective Our nine compared sales expenses unchanged in and the from XXXX period year. for $X.X third $X.X XXXX, September period the the for $X essentially third unchanged XXXX, quarter of expense was last million marketing year. ended approximately million

for discontinued nine to The change $X.X XXXX, was quarter compared in that QX now, you, million Net the XXXX reflects an year-over-year XXXX. last professional XX, to a in in-licensing $X.X asset of in September $X.X months in expense transaction. XXXX, $X decrease XX, fees September XX, September the and in decreased relating reflecting approximately the to operations third ended nine $X.X million, to to from from offset to in months recent QX as in XXXX, period back compared XXXX the year. income partially the it This related turn million principal expenses. nine net to divestiture. was months the Marc. XXXX in $X.X This third to G&A XXXX $X.X million loss paydowns as the due million, related of the quarter of the was same And in Interest increase is is I'll slight increase the by payroll primarily million increase million the XXXX. For and loss XXXX,

Marc Hedrick

you. Thank Andrew. Great,

So regarding on forthcoming announced previously in short, up milestones, finish we track. we're Q&A, before and have just

Cohort primary to our of will intend still year-end Anderson be that [ph], As and Houston in final site cohort goal end, that UT year-end. X will the track completion three. active to dosing that believe MD To soon and is is ongoing we Dallas, patient by Texas, respect, that enrollment complete currently site in on begin screening and in screening Southwestern be two to that's

clinical regulatory likely sometime for X. of to cohort, progress this be which We'll and and on Informed on then I presume in As report final plan the as the from mentioned, recently will Cohort data, for take for Society RNL up-to-date second announced, recurrent steps, the that FDA the mid-November to of plan Neuro-Oncology fall the XXXX. next at the guidance by meeting respect dataset seek in enrollment we year. half we glioblastoma which optimize data

I in in back regulatory going as parallel the for actively now mentioned and efforts, to before, CMC the So ReSPECT clinical current manufacturing our on is in team drug our trial -- the ReSPECT. background

we in-house. brought that So

second continue we that discuss DocePLUS for relates As capabilities we'll pipeline. place controls those RNL that manufacturing And to drug provide we'll further, going when if -- mentioned clinic, a well, the and trial proper be on that to discussions to move DoxoPLUS more clinical a In I are we and this half of publicly, then XXXX to partnering RNL the QX event. year, into and in also discussion. we're putting forward discussions. anticipate push to what we And to the appropriate plan discuss late-stage a and it as as

Q&A anyone any have. to Catherine, Andrew, with with you over questions and that, the that answer be I'll So turn along to happy may

Operator

McCarthy Maxim Instructions] the from line Group. [Operator comes question first of Jason with Your

Jason McCarthy

questions. for Hi, guys. of the taking A couple Thanks questions.

in we as so will as terms of in? to [ph] historical First, to the far of And of sort be these be state will be could November, so, survival matched at data. data disease if expect it And patients see if kind historical overall compared of are some data control that seeing snow in that control. the would that we

Marc Hedrick

still patients recently Yes, alive. and The survival Hey, caveat have there that be Jason. been treated provide is, overall we'll there'll data.

overall the be meaningful have on -- both still can are patients that So take we alive. conclusions a look we that to we'll can able so much expired survival. or Only is draw are at

I don't pretty So current well it sort have blend we we'll to overall known disease then historical, an discuss of survival, the match the is to six-month a But control. setting overall intend nine-month in the age range. to specific or survival a think will be And there. in be

Jason McCarthy

with arms also that and FDA control or just Phase to study? the then with the you're that's frame FDA to meeting map a about the about using thinking study smaller as very avenues this going has lot to that last to thinking And for and Phase And they're we're out. that or synthetic XX large program when Great. RNL registration study, XX actually however, a how the getting you We Are start groups the it changed II open external at glioblastoma controls and that for be trials space, months. months registration towards to GCAR, II that found drugs seeing in a now different in the you're all looking you're seems testing. agile these control

Marc Hedrick

been are I decade. -- back they improved since almost a as maybe in there hasn't Yes, going know, recurrent you think anything setting,

out discussions We've So FDA. not depending be will status, the on at Track trial. the tough something a out or of respect that other obtain And approaches clinical trial are it's forth definitely then into Orphan we'll our incorporate the Fast question, comes data using status, control synthetic is that drug problem. status breakthrough looking with

are there and severity alternatives based the of of this lot good think the therapies. on here capacity of disease I

Jason McCarthy

are are specifically question cancer which on cancer like implants then Rhenium Got like I these ovarian radiation certain and those pipeline from be prostate but and an indications, you. therapy isotope widely trials. And the there kind know just said, haven't physicians or indications switch last you and used do [indiscernible] where make comfortable of using where that more expanding areas RNL. shortlist your could on will

Marc Hedrick

glioblastoma, Leptomeningeal US indications year most and dataset there for drug That the fact looking existing areas going neck at to be might to lot be before, in say similar and an market who doesn't those current every in approved clinical indications been the have year provide data on deeper the might taken there ones acquire can will things site in pre-clinical chemotherapy. aren't closely. probably get year. first mean offer which indications So we're have that other preclinical couple goes suggestive there's area a that. maxed like not not both Anything head three [ph] out we promising that the brain, in second some Carcinomatosis those additional And we I but but is some think are related is of last Potentially you we that are about The is we're was more specifically where of patients patients the or clinical things would that preclinical are surgery those recurrent mentioned off Late-stage CNS, useful. are the interested data rapidly. the approved where the these in, and -- to of where It structures potential success only think clinic mentioned I studies. -- beyond leverage much XXX,XXX peritoneal both into years. cancer we those also radiation carcinomatosis your nothing

Jason McCarthy

Great. Thank taking questions. luck. Good for the you, all Marc

Marc Hedrick

Jason. on Appreciate you've you, the Thank call. been

Operator

of the line Woo Ascendiant next comes with Ed question Your from Capital.

Ed Woo

similar My what's for in done in of you Do on or been be or Thank the either X. question Cohort increase to my speed end there expect going the have that speed, pandemic? on you've you taking been with with Yes. that timeline particularly before, the on question. delays the cohorts is to

Marc Hedrick

Ed, Hey it's Marc.

patient review enroll will We'll announce drug. the the X, increase and in dose of the will we period we'll that. both XX-day so know, volume a -- first have drug the dose of You the the Cohort

obligated that cohort. and DSMB are we back go can So days the to go wait and to XX before back complete proof, we

is So -- say it I patients. will pace that -- accelerating. the total be enrollment The likely six would cohort will a of

as having purely Just is to resources opposed And new trial. behind behind trial the academic a to having NCI being XXXX. corporate which this the also trial, the

onboard, allowing together, move more things adding UT quickly, now you those all Anderson, hope as additional we a MD is site. know, think I also sites us be third is to important to Southwestern

to a the So can optimistic that's why still But we cautiously and proceed let can then we'll enrollment -- on think the track as patient we to complete we're play then six ready be push, mentioned to of trial the timeline. year, the there. next out but step. get have roughly we end the we're still that but last that by in months I before And we're think with

Ed Woo

that state Great. And then, Fund. has how there has been any update on decision And other funding from would Cancer onto into the your indications? affect funding moving also cancer

Marc Hedrick

impact to so, indications. in might -- to RNL for that meaningful funding answer go seek I alerted, And our glioblastoma that secret about respect additional in trial. able fact week or the coming question COVID likely either COVID heard your an with RFP made also availability just But we recurrent were to in really separate So, enrollment. we has in last there I COVID be the hasn't didn't think has efforts on is for a COVID, an is the grants. way of

secret So now specifics looks waiting back we're for now around it for like is business. but that, open that

We are two one frame January, funding time there the historically -- periods, in the February have one August, frame. in time September been December, and

not a non-operable to be use on that some other in a into indications we getting areas with On to potentially for glioblastoma, that would trials submit our particularly So plan for diffuse our treating to addressing. basis, new both each be and submission or back opportunities. normal we're currently RNL these example paraganglioma follow that they're hope grant two will which plan at cycle, it's cycle, yearly

Ed Woo

and thank wish luck. Well, guys, you you good Great.

Marc Hedrick

Thanks, Ed.

Operator

of question with Your comes line the Wainwright. Sean from Lee H.C. next

Sean Lee

guys. my for goes the Hi, pivotal the of taking Most mentioned doing just -- In you've my for Thanks but that remarks, of already, the preparing has have have CMC's the batch completed and study. I question. a having questions work are been one. GMP answered, been -- prepared quick

whether forward, any least batch when going to yourself site. wondering, is all intend ready? needs. done be the Thanks. be was at produce additional drugs but Do do left I there the in expect study you the for work you And the GMP So manufacturing to will

Marc Hedrick

Ed. Thanks,

we're the studies, validation preclinical so Phase to scale. I In only our background, on along that move so it radionucleotide also for trial. the trial. manufacturing the to get with to going mentioned -- We make now, partner Antonio we're potential are scale before, pivotal of right work working We drug really to I trial in require commercial San and but the out can of make the we to, and mentioned manufacturing of doesn't liposomal them as Phase the verification I with the available the readiness kind XX% relates load them roughly it work them VNB sites. That's that drug to as X into drug not the up then

So that going are Even the CMO all because commercial plan in largely a liposomes have the radionucleotide once to loaded the of to, unique kind our the outsourced. we to facility bringing stage of and of will drug, capitalized though site that clinical a likely approved have on that the be we with fact then work. that will get outsource of And Antonio, completely background even nature is stage manufacturing fully is we'll there that lot in-house. outsourced San this then that that's be whether a

capability still to tell such supply will have that chain this sense but at and can early bring that, to make point. whether the logistics We in-house, too are the it that

Sean Lee

I all That's have. Thanks.

Marc Hedrick

Okay. Appreciate Sean. Thank you, it.

Operator

to like turn at And further over this Dr. call to there the Hedrick. I'd no back time, are questions,

Marc Hedrick

participate everyone you, that the in I joined call. appreciate Thank in and Catherine. Great.

the physicians the employees helping process. and patients to opportunity approval about company like to us involved the this trials and Just through excited to in that work the I'd to think and close, are increasingly of with potentially the the bring

good I And appreciate again, being a have evening. you So the call. on

Operator

gentlemen, today's wonderful conference and a day. Please this concludes have this lines disconnect And at Ladies call. time. your

Plus Therapeutics (PSTV) 22 Oct 202020 Q3 Earnings call transcript