PVCT - Earnings call transcript Q4 2024 | Provectus Biopharmaceuticals, Inc.

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

Alyssa Barry

Good afternoon, good morning, good evening, depending on where you are. Welcome to Provectus Biopharmaceuticals Fourth Quarter Investor Update. My name is Alyssa Barry, Co-Founder and Principal of Investor Relations firm, Alliance Advisors IR. I am hosting today's call. Ed Pershing, Chairman of Provectus' Board of Directors and Chief Executive Officer; and Dominic Rodrigues, Board Vice Chairman and President, will provide the company updates and their remarks today.

Following the presentation, we will conduct a question-and-answer session. them recorded, has replay the cameras we be being on be moment, is Q&A will website. Management the Provectus' turned turning presentation and today's will a available but portion This of for call. on off at forward-looking includes statements. discussion Today's

assumptions want to management's Please uncertainties actual factors could his beliefs. always, and based turn we such results are statements filings over for these public the of will cause materially Provectus' statements. caution other see to As These from to that for forward-looking you Ed statements discussion on call and subject such opening to factors. I differ are that remarks. a risk now

Edward Pershing

Alyssa. you, Thank

as capitalization. potential a future for is company's realizing appreciation by essential partners, capabilities this of is Provectus the to the in I my and company's position dictated believe sector. We Bengal we multifaceted essential to market and/or with provider than and, potential API business each synthesis us success. express your process an the currently update model RBS-based accessible underscoring First, Provectus the proprietary of company's the molecule, opportunities worth market Access strictly therapeutics to and medical by commercialization capabilities Provectus Provectus' unique manner financial patient potential Provectus' world's needs by therapeutic impact, for interest Sodium, of and different sole determined We in in in strategic as to and Provectus value will affordable RBS that strength, numerous Provectus' Pharm a is for be there opportunities you unique development RBS value opportunity will driven prospects value growth consequently, future front in the and RBS' in patients. Provectus' has fully by pharmaceutical-grade parties. intrinsic RBS RBS' pharmaceutical-grade and believe our to address API. driven of Rose dynamic want of appreciate for biotech the unmet be rather attendance the this for global manufacturing market numerous

is tailored the of doing This be the business evolution specific specific potential, work these the and Provectus' turn and the disease Dominic. business market to to We fully business of market RBS I'll One that, to to the guiding targets, is ophthalmology. growth ensure each may value. strategies forward model examples thus design look potentially requiring it have of therapeutic area the in to of over structures Provectus maximize company to different that maximized. With value we're company's

Dominic Rodrigues

Thank you, application drug program, provide updates Ed. injectable adenocarcinoma and ductal metastatic With Hello, its immunotherapy on to programs. to PV-XX, regard stage The cancers, we candidate wanted cancer tumor mPDAC. pancreatic X or everyone. solid lead to clinical our our

an by secure is to next XXXX, goal Type the FDA secure the them us to succeed, meeting When position the the to investigator-initiated the since what run begin at first a overall protocol, allow delivering many interest we that the to X to an distinct protocol program, in used, interested in study that that the PV-XX current we in and to trials drug year, helped X Moffitt is remains there have of the potential trials order you patient for clinical consider would group at their with that pursuing, Our and fully Ed then funding C patients, the trials study was company investigator-initiated X Moffitt we and an XXXX, joined identified that best which to realize enrollment. In to patients cohorts, at half Phase work to succeed pursuing highlight, PV-XX of us clearance that clinical this be to lead patient regard understand objects. When is and at we been could. PV-XX durable to trial I that these to in goal and current much wanted you significant cohorts times, responses that for our the feedback mean as Provectus the appreciate And or we I penile look cases, programs give in cutaneous for been able needed try cell And have these survival. by of and patients commence. ultimately that look or longer to clinical the next uveal shiny have new in carcinoma trial as identify thing puts patient at in cohorts, criticism initiate preoperative we on focus succeed. back a is shareholder would therapy. to is squamous to or intratumoral both best objective XXXX has trial, in another clinical stage. melanoma, In

treat, trial in single-arm is to essentially would and to we've period is that to that with inject saw studies good if necessary, patient. longer inject when lesions was a potentially there PV-XX there long on times was inject, i.e., metastatic we the to third in reinject is more time, end, order our KEYTRUDA, combination uveal enough study. CTLA-X, again, PV-XX PD-X seen in was given melanoma failed what disease PV-XX the of with opportunity given the PD-X need of when combination cohort side, that in a enough with has promise in underscore over you that latter the of Yervoy or enough when either And ipilimumab then the then that negative so, from cohort the we the or or don't PV-XX towards thing program, and, if reinject disease combination a And the And then the need cutaneous thesis. melanoma a there no tumor, multiple of to where Opdivo meaning, survival these

feel with the this. by that upon high so, as upon we this to is well clearance very And to that taken excited program, expectations as mPDAC with respect and bring time that the treatment, patient we study

aspect understand protocol trial so understandably it for But the PV-XX we other and XXXX, could I that patient the about X where comments in when mentioned, inhibitor. we this clinical optimize choosing in programs made study melanoma studies, was melanoma the cutaneous for first MPDAC, maximize needing also and combined a success. or again, was uveal The those to with checkpoint

skepticism with treatment respect to Given some benefit, the systemic that a have the we no generating skepticism. have local

for the we more will and that of combine otherwise hope, with effects to that were pseudo-scalpel for intratumoral to reduce this successful shines the nonclinical clinical may of be the the terms -- administration need benefits data of study this surgery or intratumoral if inhibitor. A its so following light to patients combination is be Our given is PV-XX. with the one not or with support the affliction. program chemotherapy and if strength PV-XX systemic point SCC penile the Again, here, as of PV-XX program to indication minimize a be PV-XX, highlight mPDAC in may another in to on with clearly and checkpoint coming credit, a it administration for patients, in then essentially or might done

with, would to that be successful, skeptical again, we which should Alyssa, be put And be patients where studies PV-XX very forth difficult trying the the in put is about protocol, slide, to are position so, the trial maximized data it careful very to in to be clinical best an please. to tried optimized them. or succeed we've next

Bascom the been Eye the the likely have of since in and Institute, have following We ophthalmology. about course, been part of many School Miami, U.S. Palmer very earlier the as you of at And work University talking the year leading work of group the part the ophthalmology of world in Medicine. Miller of the

EyeCo in round treating quarter to conversation meetings as referred this this area Bengal Sodium. The company, the order to company which for investment quarter, focus of ophthalmology, stage biotechnology sort is and We to of on are this a pursue slaying a presentation are we disease launch it close new where and using Rose to forming we've seed of clinical initially current NewCo, keratitis NewCo and using start-up in goal fourth the also infectious XXXX. at

Additionally, we parasitic to for where it the being National by topical Rose standard case, this compared ocular in is And infectious keratitis. trial Institute a therapy readout indication National Palmer's currently Institute innovative III from funded antimicrobial anticipate run In keratitis. and we therapy using, fungal research, infectious of Eye a India. photodynamic treatment Bascom a expect of the is trial being Health's that that readout Bascom again, setting Palmer's data antibiotic that involves Phase Bengal in

We expect again controlled read randomized out that Phase this trial quarter. to III

aims XXXX. company a new currently the half of the with in first Finally, meeting FDA pre-IND submission pursue next year of the to

the would path by subsequent The investment that assign be part that exclusively strengths valuation, pathway of the to affiliate for that generated the that all stock generated, Rose for of commercializing be Palmer, the or be indication. million will balance Bengal spin of acceptable would as money the of University pure manufacturing we initial its active completing with to ingredient, Florida, an clinical was which based is keratitis supply from will capabilities create foundational company submission over of the examples, new be stumble course, to issuing time off which Bascom Again, would stage license a version reflected of create at pharmaceutical-grade range University will of of towards put pre-IND ownership approval we efficacy. We've to is cost upfront, to milestones course, we the would data continue quality, as is using vitro in Miami, we support as this to new million, $XX would the a to drug stock would data seed to other up for hope stage. Rose hope CMC talked lots post-money essential that and Difficulty] has Bascom or the So, and NewCo common investment from challenges API. an pure Sodium initial million on been company. The clarify Bengal are to meeting, $XX in the taking And pharmaceutical initial also with be and in of where its seen together an be which is a achieving highly itself manufacturing, the while safety or therapy near license round, infectious a NewCo this ensuring treatment the validated and a agreement clinical of what for data, the funding producing through Palmer's it of we South of arrangement Sodium, line of money we Provectus at on substantial define manufacturing in company getting said, and exclusive and the long-standing tranches, that having at decade the produce that and subsidiary immune that would Brazil of the Provectus data therapy. the been CMC license data has to companies regulatory India, of was rounds approval for of where the success to well sheet. The essentially this would milestone-based $X in funding which forth are [Technical Sodium of funding couple not Miami out strong side common preclinical Provectus' would start-up Mexico, or valuation of how and with license Bengal a to X learn more than provide ownership we mutually Provectus our XXX% Rose saying

under important work So we trials. the something highlight drug and an line, that and on clearly generating to water program, efficacy development but through that's data robust that background clinical almost component the want any in well as as as important it's the to and we safety

Provectus, Bengal research Rose Veripure relates establish their We've NewCo in to Sodium manufacturing, we reality in for simply own. to and for Rose course, on that the Bengal to should nonclinical on them pharmaceutical-grade for Bascom the is we Many first Provectus' in potentially to your molecule. The processes opportunity the Sodium applications Bengal Sodium pathway scalable and producing is have Provectus quality XXX% of of pharmaceutical-grade of collaborate in to the that is Veripure achieve all this has there work approval Rose that. branding, and and evidence that the a and from that become therapy. half Miami with world. to you of at the notion approach to researchers treated where of we journal proprietary -- being innovation behind obviously the This pharmaceutical-grade on provides our any aim is Bengal Bengal course, exploration idea followed. Rose next many pharmaceutical-grade medical Polymer primary the -- of trademark the API order As by, open of research enable third-party to for would represents of Bengal able you of medical and work message articles patients the the therapeutic a is the Palmer quarter for hundreds early ophthalmology in for API The other platform? in Rose launch this we've regulatory And to all of and of collaboration taken the of technology a applied or viable reason treatment on academia around Provectus' We molecules a research of name to Rose Rose of the Veripure. Bengal arrive the based this first of global remember, hundreds make round discussion to the of directly hear time about University steps we year, patients. with addition diagnostic with be creation Veripure like sorry, us, eventual And We near source advance plan for of therapy, done XXXX, that become Sodium of Despite the the at of shareholders and have introduce this you molecule, by reference the what of many will reality research. source Bascom create purity. out Sodium API. Ed, that an all --

Edward Pershing

of I our you just share the Sure. delivery to almost they've of program approached XX just this medical a scientist technology. therapy research drug we work it's for and unique their a intratumoral to and Basically I opportunity Provectus' and basically technology eyes aware openness applications. together. using example us month, made in model our presentation, this with that developed And awareness the it one part spent doing very drug aware we're open of their with because concluding by years how what a this they've want development. very approach and have approach was development to about They of our that, beyond could And we're is how in were that, to in consider of space of Provectus and advancing becomes Provectus source possibly attractive from just

why And other technologies ongoing be this so is to that's diseases. a very tangible that recent of believe also example in we cancer to Provectus' advancing value and and increase the for while success, also Provectus of business way new better will fundamental going but model a addressing

over a an us you research. And to the so, in fashion nondilutive drug so shareholders it encouraging thing capital and one directly is of other turn investors. Dominic, I provides for this it but that flexibility not development, also find I'll of only benefits raising aspect on

Dominic Rodrigues

on treat a opportunity PH-XX. very done, for provides large promote Provectus us we the Ed. work a XXXX, in able a both the full-thickness clinical in Rockefeller research already wrapped Galveston. highlights of nonclinical effort City in has showcasing, up, initiation the about, dermatology obviously, the stage as for feel in we wound cutaneous position large advanced a we'll nature. a and we anticipating particular this third to work drug dermatological growth to to set applications clinical candidate, target diseases, data nonclinical the of particular, will conditions care. What indications, York animal the are really is of range Branch more. are well is intersection again, University you, New collaboration a has with fulsome by University Texas program to once first this and collaborative to programs in drug have opportunity use expanding foundational formulation And our And disorders that based a and and a quarter study commitment that be as study this been very global company's hope of in is a Medical wounds, addressing in and also dermatology which of Thank The that excited be

tissue been research as to Veterinarian we've vivo in nonclinical a for you cancers, with know, as the canine safety in in in collaborators treating of work Provectus soft Medicine establish activity, Tennessee of University notwithstanding College been a relevant data working data vitro and of PV-XX very as well from nonclinical Finally, literature. the foundational sarcomas in has Unfortunately, of and dogs. set surprisingly its that inefficient, lot

we company their these, reality in out researchers and developing from published presented drug Nevada, carcinoma consistently refocus pending articles, to sustainable, neuroendocrine for Drug, realize and expect this to be receive then, but The And head-and-neck AACR a with research New us the repair on us development, a of of quarters. And Bengal presented of from of patients like with was goal cell getting who and to work research then the to regulatory an streamline fashion, course, to power so, Investigational in API treatment journal we at Q&A Alyssa, I'd Rose year. animal done investigational IND, clinicians. leverages more the this myself. to towards order about we'll having by acceptance version at human of in and to other squamous -- looking turn to over it tumors their the pharmaceutical-grade Moffitt produced upon believe done Veripure, continue the also at currently work in by in here PV-XX's is order drug partnering on metastatic Vegas. Again, the data University encouraging own more eventual can being current with to bodies. And regeneration our that cross-references Ed and and to is canine tissue a high program moderate the existing And and collaborate the reach as stand and objective the then we're with information that company, have by that, nonclinical articles Sodium with that to able treating existing be done that for made -- the by Las application liver regards putting form then, purity dreams new that earlier to nonclinical forth work Australian will we can clinical coming

Alyssa Barry

Thank very Dominic. That overview. enter to and the for There is chat great. open your Ed Q&A or you am a going audience much, was to function the Appreciate that it can I questions. questions into. up you a

So to and will up it give just we'll we a questions. minute, open then

Dominic Rodrigues

on be we'll our turning And cameras?

Alyssa Barry

Yes.

you're So question Can around that a be cooking few in that able for that has quite else just work. What you is to -- there's collaboration share? collaborations there opportunities come underway. might

Dominic Rodrigues

Sure. me here? Ed, to would you just the questions like address

Edward Pershing

PV-XX, I'll term not to Provectus we in you well but of passion and direct creating of drug Dominic then exciting. The earlier medical I challenging my years. inquiries bring the particularly interest. it engineer to details. the that's the Dominic companies, was we've cases. one to of advancing, of that referenced contacted, Yes. could advanced been is open the for very how But development, different more knowing a inquiries, initiated in and is very medical are drug the Dominic, that I things taking also technology occurring this because want of And sourcing that's some hear. one, immediately over when think, similar that in how comments can that to and getting one those the utilize is approach benefits further I recognized molecule, go Even mention leading our we're this is the XX into and technology was for stages, something

Dominic Rodrigues

for in one its select Yes. when capabilities, with potential we at and evaluation. outcome do with to would of be that terms clinical meetings hope, protocol gone that partnership, PV-XX would their that that feel and PV-XX trial to partnership, demonstrate least data them of it have regards Ultimately, for the look, the gone vast under able being display companies we is that immunotherapeutic for is combined we calls pharmaceutical we PV-XX, we at indication. what In the have -- for fully mPDAC the a really maximize past CDA with the chemotherapy patients study with shared tough optimized that said past in and

critical, And and so, believe and third-party Provectus future study work that about we mPDAC and from all and where the approval the emerges inception the of need from since us pharmaceutical the dictate It's developed on. knowledge that and data it's puts position we've its companies that that the protocol, to initial in generated we well-designed, has that gained will feedback, the the it dataset from pathway. a focus PV-XX that well of positive

Alyssa Barry

Dominic, maybe... And

Edward Pershing

most do would it time note enormous this add very of these be yet to benefit period that relatively have for to in not first step believe that, clinical over of shareholders, that can intensive, is and short clinical be evidence PDAC cases. I capital conducted the compared we will could challenging trials taking basically and we're a

so, And down reasons of that a pathway. for there's going lot

Alyssa Barry

segue can for Dominic, to there? there maybe Is anything a is we comment a question on mPDAC. around this timing

Dominic Rodrigues

Yes.

trying work start teed a And that in up expect within is after trial would go Moffitt. assumes, the that study parallel received that would we've quarters quarter of the to X clearance that and/or course, we the FDA. So from to at

patients have provide feedback updates to as -- typically or X at the part starts. And months. to have survival sense median to trial question As rough first terms we'll a once a we second when of endeavor data, the that good annual X of the of you'll we we start an a then study, the meeting, in once -- have these said the

can out, better worse. presumably unfortunately. as study good then patients are But are will there, doing And have than that of you a the the be being rather so, longer we'll very how the that recruited, tell patients pushed that in doing measured quarters study sense is from really

those much commences. provide as the so, can updates when we'll study we And as

Alyssa Barry

work talk bit and canine outcomes the around we've doing. little been here the question Can A cancer a about that you the approach?

Dominic Rodrigues

Ed some give that areas I comments, worked and more we've collaborations all of to in the I'll relates different a Sure. as has in. perspective macro research think the it then

have over lot takes you us experiences work resilience in these really it of then a order understand and quirky, quirks and So, heard years effort perseverance is let by and and grow. the to they're in area their curiosities say and molecule expand scientific the through researcher that and to sometimes what seeing the their specific specialty

And when or so, there's Regional overcome strains, unfortunately, working COVID where was let's safety. sometimes to with some as understand of with hiccups that the University Laboratory, to that work in when line programs initial rabbits administering works it, with happen to it how for such done the say, cell molecule, Biocontainment Tennessee they're they're need trying some be

up or effective. stubbing not sort and their clinicians and making terms experience of a with experience in efficient Sometimes, toe researchers of based lot end off prior their of with assumptions of being the molecule

often these vast to help researchers And through work knowledge the has amount that the order of in that generated so, using program. them company we with of leveraging all

most of it works. time, Sometimes -- the

minded, terms with simply a bit of little in need molecule. they they more Sometimes, because be to of sort be it to need just doesn't flexible open working the

just struggles that. them needs we repeatable track science, overcome to of it, the of the and very, with with XXX a sometimes law physician to happens just so record reproducible, X very strong it work have and averages in that need We that

Alyssa Barry

sorry build different of that? a -- do couple on Looking to there -- you Ed, at want

Edward Pershing

we Dominic's continuing to just to the to we future I'll in space. have that agree just At Yes, we comments. I excited way, what a each But coaching, had the of the -- getting that do adds say very have collaborative, and pursue holds and to step sometimes lot forward delays to of outcomes. arrangements, look about with we're

Alyssa Barry

and around the calling There's several you of I little projects diversification Ed, -- trials opportunities. approach various you different And Is know the all underway? processes know we've underway. I'm there just these of a the got anxious, of about terms the it bit excited very projects on approach shareholders, questions I can anything time. about and timing. of can take timing for in Dominic talk and and comment that

Edward Pershing

Dominic, take part, aware I'm I'm well come jump and first you and the then people's to going in. of concerns. by

also Some you pursuing chasing too that In different areas and to each use of object? that pursue, have posed And some each is on cancer basically financial, latest Dominic case. of we is are from the not shiny in it potentially not more the out any is, way opportunity it our future. for diverting creating in drug many the it's What it's knowledge, applications. and while building in focus I the question, significant minimal the resources the we've us As and in gain and the case, requiring financial are these development? continuing phrase, pursued very

use recent would pathway. of very, the we're I that the very saw potentially example it's which that PV-XX benefits. something it of it's mindful be a very, cost, potential benefits to potential Provectus' would synergistic then direct and I most encountered, low of. so, and development because other molecules And use But

and we as consideration of resources, we opportunities, discuss of time, the resources. mindful just so, to very financial want are And

Dominic Rodrigues

And I'll spent almost protocol. trial add. we a With the with, mPDAC, year for respect clinical example, to, finalizing

So there's into study. the the be meeting, parts a need addressed lot of FDA begin an component that to as for Moffitt such lane to getting

start give so, things are trial. that will us hear because we working that be start that very those trial we been we'll the and And you'll will clear when about the guidance on, we've

to again, do that consequential working that, this et from work, project, as Work ready a timing They of in we're announce logos, when we to we're you'll so, names, is quarter. say is with the And Miami hear regard branding the ophthalmology, the to Alliance being for formally cetera. lot launch well. horse's Advisors hopefully I to mouth. In our were it the done. And NewCo company, mean, the

company. be to And nondilutive an again ophthalmology point, then so, NewCo ready. And in we'll the a position funding like when of something and announcement to generate to an for we're make presents Ed's opportunity more

incredibly synthetic an small bioactive have molecule. We

and I of think the unrelated as collaborators as research Provectus third-parties done. it's unaffiliated clear, well that amount and pretty have its

And with different provides encourage on strong Rose potential we establish promote value, it more for goal in looking value a and so, shareholder or essentially which we're more for that science repeatable, Bengal, the ways use is can shots and and reproducible shareholders. that of create foundation

And focus shareholders is continue with that that number we opportunities we impatient we've support we reward being potential taken. the that to drives clearly been we've We mindful so, understand nonclinical dilution to value. And while and at to execute shareholders. way the continue and in the the science the the trying opportunity that shareholders seen that times understand for to think Provectus been which data, always increase time clinical, because it's of be will with but for what us, may of and outcomes

Edward Pershing

I've Dominic. got pointed comment one to

is because imagine which and demands not I trial think a been impacted us example and financial the ] Provectus or great to XXX-patient the cost approximately our results the the of this should that fact ACCO random [ time of has we of next be of has month seeing benefits control no here demands.

already as India work a of concluded. can in And as well be that so, that work beneficiary yet direct done Bascom they've Palmer's we

Alyssa Barry

patient a of questions that's recruitment. to do comment that? Maybe couple how a further around our expand you improve we or segue Can good on

Dominic Rodrigues

Sure.

because And patient single robust patients. And we're on part, patient mean recruitment, successful of need single Moffitt by are very high oncology very recruitment. feel organizations, we studies we generate both arm and, they departments and for comfortable large terms sites data, outcomes albeit, data. to high quality to with In in demonstrate focused quality so both

who clinical indication early-stage about And so, particular to they're with rather solve. a and than trying to PV-XX are rather passionate at we'd application investigators, multi-site the sites trials that this of work stage, have disease

were we there hope generates, can of raise makes and recruitment. study. because to the that again, understand off for then okay, success we sites make data multicenter goal so, hope penile past from strong and prior then a think we running fulfill move the recruitment will based these trials there's the sites that data to And we foundation, capitalization that a we're of sense, to that where, sure that in questions results in that data was about market would and sound pathway mPDAC be SCC, or clear then, initial that can But be approval, there's multicenter where the enrollment funds We of is studies the generally better. those the always the ability

Edward Pershing

to add specificity as at just I'll patient Yes. which your key look comment. consideration decisions. is enrollment we The a make at we probable

patient recruitment, actually to institution standing And is from national not their their the standpoint so, programs, relying and as what a not, as, directly current the in upon success able as far We're involved they're at make physicians and these past outsiders. in recruit looking we're decisions. we

very prior trial, assure we're recruitment, So before I you there as any was attuned the we there realized but very as we in was got melanoma patient control, far before poor begin patient to recruitment, initiative. capabilities

Alyssa Barry

Question around status of POETIC.

Dominic Rodrigues

Sure.

in been that of in antiviral situations. -- programs X So the instrumental were the we ways proprietary In during pediatric we relates that we've where partners to of of on the coronavirus, X ready vivo modeling project been component validating, the it did cusp of computer cancer wide been some as work relates that the to prolific also areas of of and as and do might their X encounter nonclinical case didn't refractory administration the the order continue. tumor trial see And in POETIC following the finalized leadership of of the related unfortunately advisors the drug to Cumming had clinical were partners not or only PV-XX we our due and of understand, not to to showed has the -- relapsed working circumstances oral potential work one protocol continued or across of researchers Dr. for most -- outcomes on. silico appear decided settings you been the Having or and Calgary, for or shareholders School administer to hematological tumors. He of to led properties. it Medicine, we in vitro also Aru indication of said POETIC, to other that program, pediatric as at enabled, that he targets in challenges He's of he partners POETIC, an initially have the to for us a us is a of by X relapsed its many a work with aspects if other for University then that to do been that on What that, in Narendran, range behest of often in refractory to most appreciate in where go. solid cancers for different programs.

what the many where notable divert pediatric an have and, will We may other a because potential, we our some a And held POETIC rationale opened respects in a lead but fantastic to an than we molecule. reason a and a a that vast opportunity the terms that bioactive Narendran that POETIC, meeting and of us feel the something with but to science the work research Dr. point. But probably, be with indication time for relationship go, patient sometimes of it been to get it's it'll eyes ready institution, might did he take prolific this so program. that there references relationship working to of Ed rather strong call pursue strong you're the with that was be to site. he produced And there in

to So, hopefully on some that. Ed, you out? do that'll give any you that round further feedback have comments

Edward Pershing

organization. as I far personal why observations while the view as I wasn't No. relationship, POETIC across from my the own pursued it have POETIC

our just to in partner of He The a a think better has centered of that benefit for been success. and I a identifying pursue is for and people. than opportunities on great cannot ask just it very vast Dr. Provectus Narendran. instrumental couple relationship

Dominic Rodrigues

throw And in. Ed, I'll just

understand you dose occurred unintelligent of story his or late that understanding he that agents. And of Sometimes, toxicology amount where them from this a that will had Narendran rather, using as while was is from familiar data with of the concentration the of other petri safety a partners I'll quite call Provectus in what studies work PV-XX it not data, work compounds, and of with Bengal when or liaison would trials raised, other the prospective vitro presentation you oncologist use give use that to partners, people can toxic we'll is the those have have. a point Dr. better large our POETIC Not they're understanding at of in than giving don't his pediatric meeting drug in how they significant share PK/PD Sodium questions a pharmaceutical that higher XXXXs amount nonclinical about that a known, meeting we than meaning level I again of didn't company strong leadership late well that did. what one clinical where XXXXs molecule there data, level as that his be the Rose work, the higher understanding that understand of early well thought a established molecule. that of could a for in some systemically outcome dish given of would in

like the into way, their study and taken to of ultimately, prospective hope the of that? a that partners it you show all table, and time design work to calculated trying And understand in their middle and mPDAC one then push harder help so, produce do are to you're and we the need on have boils other ultimately study to down get, looking But, and skepticism, away organizations guess, any comments notions we really and a for. Ed, let blow to assumptions. will careful data and where the the just and think, and the I think go it's to the ready partners sometimes, again, answer or preconceived that I you chips any your other answers risk

Edward Pershing

that you because I see that but my you'll in that your back on, screens me and Dominic, away. telling got because on Yes. I shared Dominic just one, smiling considering I I help I'd comment call, earlier can't was if story thought

across that me the because bad knowledge realized POETIC, something and let of room which be made as witnessed were in statements, I Literally to impact of ends Dominic, we biases have, move we to decision. lack it of just So I've into drug. POETIC the just and us of me, that without of leader. And, a able those and so basically are encountered many it. saw when a it it ended a being benefit and were were past medicine. blunt the doctor the what in far watched of Narendran. And inherent and adequate think, relationship up to we allowed encounter, I new did up that But as about occurred and some it what career by really we but what and experience leading a capabilities because result my distills times to faster, it us, cross deeper to It unique. a for I quicker, knowledge as further, of drill much what There's with related

a that. be to come broad there what Dominic Narendran, was transparent. we POETIC, quit that key shared so, But totally relationship and just great just lot event of on the things a pursuing across which have out And doctor in was of focused

Alyssa Barry

Australia? pursuing Quick still on approval we You're for Are one mute, in here. Dominic. you

Edward Pershing

mute, Dominic. You're on

Dominic Rodrigues

Yes.

at approval at pathway XXX for endpoint the run that hope, to the The that a an mentioned from looking the it's ultimately approval with years more pursue to look in that a demonstrate, time. PV-XX opposed and care at have. approved be require a that you would were you're survival progression several mPDAC than study perspective, on where makes it's and melanoma a and led more survival I confirmatory running sought given have money we with success in is to melanoma, opportunity free drug say, that -- overall that financial meeting terms not various we ultimately of spending partnering cost pivotal been the because than think of Provectus and more whether the XXX, or looking study. It results maybe and a annual landscape patients simply for the we or financial study, more you study, the Again, in mPDAC, at to over to or the chemo it let's opportunity because it the combination would with standards then be -- rather avenue likely just this sense be combination survival. And approval using of at a as of globally. the as component an would have when resources will primary So, of Australia the data that that we all now overall to, for cutaneous approvals looking

Edward Pershing

relationships Australia. even I broader and oncologists will surgeons, pathologists even did across this. with develop the and share oncology We oncology leading

total of the relationships paper think coming what supporters And have And, the now future. in Dominic, XX. we I think they an significant expected near related to out tumors neuroendocrine capabilities I strong the molecules' are. is now, at are

Dominic Rodrigues

Right.

the we've So gets there, to, think again, we work optimizing that about financial the in a resources that choose spots protocol our PV-XX to done But has disease position of and to with that company value and the have. and in we they forward. potential and the being that prudent move every patient clinical we've succeed contributed a put it to got pick we is trial each terms how

Alyssa Barry

a Bridge trial? the this of Is PX Please Question same a trial. the here. expand as details Great. on

Dominic Rodrigues

Yes.

material same have provide molecule, API, pre-IND to clean when the are. Certainly, define that grade or study submission more information, the approaches FDA hear non-pharmaceutical is again, generated the feedback that grade, on, but data we don't which from India parameters help we'll commercial the what the and, has the of meeting. for from company need the will Provectus FDA's a the Phase will it's so, study, and new bridging was III the contribute. We the So prior essentially, situation, readout

to meeting shareholders. that that And from the in much will so certainly have update a once minutes better we position be feedback,

Alyssa Barry

along around estimated in generation furthest we an do from RBS? believe and revenue to see programs the there Great. are is deadline Question approval which here maturity,

Dominic Rodrigues

revenue something Sure. profit. It's hopefully always we good to and generate can to that get RBS related

a maturity on embarked cancer see was pancreatic you'll III which a Ed prior had metastatic Phase I it Germany's though joining which which FDA, that, trial, study programs, a on, bright at the of the it side that CMC. has we the vast In done in long b-farm, that of PV-XX, whether randomized of whether terms very was a focused that on being trial reputation and already I company analysis was we of has to had the even have Phase we to CMC look terminate, for was on features the of because the

where approval Phase terms the comes Palmer treated and time, going So, we be a the out been It's infectious have Project Bascom -- while it's for to sort But simply filling of patients accelerate seem in which hundreds of checkboxes FDA back. funded study, a either Rose -- I or randomized the Optimus Phase optimization work would a RCT in ahead trials. the controlled Phase clinical it III, into it that comparing with of III a for that would first in with trial. steps position you IV is that number dose would that went for the dose a -- your NIH by the a of Hopefully, that mPDAC. Ironically farther interestingly, Bengal of positive the of to data in study and, be out generated in hopefully, what design terms designing therapeutic which keratitis. we setting some outcomes, in we move program the interestingly, data existing that are together new have net work escalation, in

needles and with any outcome in to And versus alone. of provide demonstrate that opportunity. as understanding care clinical so it that's a you're pins that why of does standard-of-care randomized trial the all comparing standard relates we're When treatment, we're to very but excited by an clinical study, benefit, that work, on it

farther Palmer that of a terms developed have. comparative in have its generated than, generating sort terms of ahead, ahead it's we which is of program data in what or interesting So Bascom may that, is farther

And look so it. way probably the we'd at that's

Edward Pershing

being existed effective care is. NIH the of that in well initiated, non-toxic would used that a drug in just that, brings Dominic, of patients. the more it of a found have to eye X things over eye. From going connection that And to work. to about And XXX potential in not stay To was than be the the nothing talk NIH indicates India that so safe Rose fact our perspective, trial, also, to there's absent it's the then Sodium nature investors, pretty layman's talking I about Bengal it the how proving that

a no advancing at along it in benefits has the our company it to work and efforts the so, the ophthalmology that And company. cost number been as as to is, far is of it's virtually

Alyssa Barry

forming move forward. around EyeCo be company had that any program medical in needed That's Provectus? will type as large here Merck organization with Have companies interest great. show a Question the such of we to

Dominic Rodrigues

Sure.

money a unveil the for private NewCo. do be corporate from So raise And capital straightforward can organizations, of a down EyeCo as would we're venture will essentially this fund raise the name trying a or private whether companies can it it that that quarter. be Again, company, middle fairway vehicle money organization or from C-Corp, advances. to the we'll

the last In company. raised, terms ophthalmology, looking the closed like for year, of with a question we see this like the companies I Merck, and revenue transaction sources, think earlier

a And public from so dollars Lomb, market obvious, smaller partners, measured billions Novartis, and there cap. companies, smaller the is Bausch meaning Alcon, as in etcetera, of of well prospective of good number other as

and, an position interest. a again, slide the start we investor deck, on candidly in we to a to once company have really doors we in and a then position launch for day we're and waiting so, are generate just And be knocking have where to

FDA, to the Palmer's grateful we're for study. partners asking be cost again, because, prospective and itself. do, you that of But today, for to data, scope, certainly to provided timeline, may aware this a immediately pull investors go perspective of the to they money on get not Bascom work precedes bridging seed make size, though you even have together particularly the to want reputation We work, the the funding prospective

waiting out to and And doors the to that, company. knock we're new do need be in to on the for so, order timing people and introduce we to but get able

Edward Pershing

to if increase code, short emphasize, cost just seeing, Provectus, could to with our the timeline we hope in be to of we Provectus. it would benefits to I achieve a valuation results which minimal a relatively seeing the achieve dramatic

call something would the And horizon significant positive have that on impact. a immediate very to so intermediate could I it's,

Alyssa Barry

for I remarks. questions. know of great keep really I'm at running to Lots wanted the Ed, But but we're right it go ahead. slides here, up questions. through your to please to over going the you hour, pull I'll, I I closing wanted turn keep but to to

Edward Pershing

Dominic the get share and most or and of the value, questions closing, value company, and confident of and from the I that capabilities. And it world products. value the price unique common to around In to fact and Okay. cap price. only are can shareholders we're of interest company, future in we company it pharmaceutical so molecule recognize its that's reflected comes value the the key, one we've centers team the all we the common, And today conveyed the grade our in why that about the back whether the most hopefully share manufacture

position not that. about unique more a in could we're excited So, and be

financial is an us be the gives company its time. advance consider and trying an we business do in in to mindful continue whether opportunity a to be medical in in it close, agent to also, as aspects. company It market as we this, risk to think so to use and, a or reasonable that we And as we possible, model I do do this stewards fashion various but risk, today's, the also the trying risk the drug diseases. various achieve advance models again, that example as all or appreciate of responsible fashion to EyeCo meeting, being I interest initiated full may to prompt things treat all valuation. And in way your of being that as, so Provectus' of risk, bringing would are always sound

consider environment. a those, FDA. And would closing what we about speculation attention call had There's going oftentimes of to the mean the I as a to one the countries And presidential to companies recently We've that's of various, comment, I would just which as your so the as we're know a so say, that mentioned is will as FDA we of information, the don't agencies, the macro can, my had election. impact successful and be to and across fashion approach feel be able possible. that do where, be, we've to to like execute we impact regardless what well-positioned, so the tried in as sound timely with fashion journey of this do in to but we lot

appreciate and Provectus we it, you the support, Dominic your others what -- understand so it confident interest just Provectus holds hopefully your and future shareholders. so, And of about in for are why about the and

Alyssa Barry

your very Dominic much, questions. for and of for today, being thank thank really your Thank rest Well, you. you Great. here, everyone for and Ed, support great for a to shareholders holiday you our and Wishing your season and day ahead.

Edward Pershing

you, Thank Alyssa.

Dominic Rodrigues

Thank Alyssa. you,

Provectus Biopharmaceuticals (PVCT) 14 Nov 242024 Q4 Earnings call transcript