GeoVax Labs (GOVX) 4 May 232023 Q1 Earnings call transcript

Good afternoon and welcome everyone to the GeoVax First Quarter 2023 Corporate Update Call. My name is Jack and I will facilitate today’s call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; Mark Newman, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH, Chief Medical Officer; and John Sharkey, PhD, Vice President, Business Development. [Operator Instructions] As a reminder, this conference is being recorded.

At this time, I am turning the call over to Gabby DeGravina of GC Capital.

you. Thank following. the note Please statements in the Act. forward-looking within may this of the presentation meaning Reform constitute Private statements Certain Securities Litigation These in management’s to statements on and are subject are current uncertainty circumstances. expectations changes and based human Actual be receive or GeoVax complete can statements and and of to development licensed to factors GeoVax’s these products; infections included timely use; due GeoVax’s easier regulatory characteristics that manufacture and and be differ safe development it’s marketed; results products to whether with products, a other over manner its GeoVax required which in product products there use effectively control. is the to materially manufacturing desired may than will including no capital those to favorable prevent approvals in will humans; enter from of into in factors, necessary GeoVax for distribution candidates of effective GeoVax develop able and more be variety will product agreements; such will has vaccines candidates a targeted competitive GeoVax’s raises maybe no these obligation to and statements not to assumes do forward-looking intend so. GeoVax does update Exchange in forth Form More is about factors Securities those filings as XX-K. including contained these the with and risk information factors GeoVax’s Commission, set GeoVax’s in

my introduce is of the to Dodd. pleasure David? It GeoVax, now Chairman and David CEO

XXXX, expanded you leukemia two viewed in have soon. to as the is X and GeoVax Since with the of the support trial third Phase by thank of start for corporate the patients the and trials program participating initiate Phase evaluating and has clinical for FDA lymphocytic among booster the in GEO-CMXXSX; call. afternoon also, enrollment chronic a vaccine we clinical Phase X and expected Gedeptin CMXXSX, Good the X patient supported update

monkeypox, omicron We further include also and vaccine. to our variants, rights CMXXSX COVID-XX expanded all recently our smallpox, related to differentiating

are the MVA also priority, focused the and progress manufacturing well of vaccine line the against monkeypox cell CMXXSX as on Gedeptin smallpox; transformative development remain our continuous and implementation clinical GEO-MVA, we our process. While the as

we expand million difficult our additional while year, our clinical related to for investment This us our strengthened process, opportunities Last also sheet a adding manufacturing adding including our the expanding current including further during programs. and biotech environment enabled sites, to programs, development near-term very balance industry. oncology especially MVA $XX opportunities,

that year. through our initiatives expect this our clinical position of the expansions We cash support and will increased remainder program other

supportive opportunities, will the government, a evaluation and In funding. opportunities orphan to from and among strengthen received activities, business the resulting opportunities further we development related suffering program. non-dilutive balance orphan from and clinical neck therapy the drug currently interim from trials Gedeptin The current stock product evaluate FDA to cancer is sheet, our NGO for clinical expanded patients has trial designation has cancers. drug has advanced funding and multisite head and

cancers. neck cancers are There for our neck and the of XX,XXX annually, target population approximately of are patient represents indication from XX,XXX head medical approximately are annually includes who initial other initial failed approximately cancers new in Our and resulting US, and and therapies and cases head and cancer palliative XXX,XXX receiving approximately patients, head-and-neck annually XXX,XXX deaths care, neck new targeted Worldwide, there population. deaths. This interventions. head having cases the

we unmet funding need. this represents the FDA the clinical critical address. cancer a neck hope need The the unmet portion and of head advanced from which program recognition initial medical of XX patient to critical underscores medical suffering Patients

review patient Our of year completing the focus study including by of funded XX-patient anticipate results. XX this study our is the the the on We completion FDA. yet initial

expedited BLA the will for our an also with program, for expanded recommendations FDA discussing with FDA along filing. while an review results those We the with the potential

indications. as about inhibitors. are potential other as well as expanded in significant Gedeptin as monotherapy, with combo opportunities in and therapy outlook to various related immune of as other conjunction such other in tumors the advanced the foresee We and therapies use cancers, head excited well as We within promise opportunity neck addressing checkpoint

also We initiated. and already activities with Mark-X in which approach. tumor-associated worldwide synergy potential of support anticipate we Relative commercialization, business anticipate the development to antigen for partnering GeoVax have collaborations use been

the individuals in opportunities targeting expect array rights next-generation This and vaccines The needs of is various and hold critically current current presentations worldwide. and Gedeptin for for We of inadequate. needs indications. important significant in to vast both of of antibody authorized Gedeptin within novel authorized monoclonal providing immune cancer the some conferences, a the robust COVID-XX protection oncology current patient approaches, advance from and oncology system, GEO-CMXXSX, arms authorized cellular others, vaccine Throughout than the partnering discussions. immune unmet addressing we which durable vaccines. our we are addressing for Gedeptin worldwide participating medical of compromised focusing vaccines all GeoVax and use high-risk more various represents XXXX, antibodies whom on the populations COVID-XX are the the differentiates with in

therapy. at those various sickle with abated cancers, unable as In systems general, to risk. to approved blood high include renal such with such diseases adequately cell lupus, and are on disease, vaccines autoimmune those positive, immune immune patient mRNA populations anemia, Such HIV respond suppressive groups

clinical There approximately vaccine population, XX U.S., major critical next-generation overall the for over we vaccines million individuals. COVID-XX support development. worldwide. to million are need with to there And is XX leading CMXXSX million individuals is this believe a the such next-generation XXX In in within the

in article to specific both of constructed protection those induce CMXXSX specifically induce proteins T-cells nucleocapsid and Our against response on SARS-CoV-X infection. critical the to include protein, the protein New focused is antibodies vaccine the spike SARS-CoV-X a for a and recently need highlights for to optimal Medicine immune to the and England Journal broader published the virus.

this and reported were strong in Lancet last T-cell immune induce ability have antibody responses The Microbe nucleocapsid against systems evaluation patient especially the does, both of results the study antibody among T-cell in year mount Phase depleted CMXXSX effective both data. X and critical is the spike The publication Clinical populations, demonstrated clinical responses. immune of with fact, of who the adoption those responses proteins. to

safety presented trial patient the Vaccine of compelling effectiveness alternate New of for undergoing at the Phase to immune development populations. X DC, data the potential highlighting targeted response the this continues use hematologic were vaccine vaccine supporting in World patients April in and testing treatments XXXX, in provide cancer. data and Washington of Congress different types from during of Clinical this

with of concern. that of noise It current variants died that have sufficiently COVID down, well to authorized is accepted and the is to durability seems While unsatisfactory. evolve are the their not SARS-CoV-X vaccines continues threatening protective

Project of House variants White improved the In a few fact, protection enhanced follow-on billion Operation and Speed Warp with initiative, weeks Next $X ago, a against Gen, vaccines just breadth seeking from the announced in the months. interested clinical the clinical We durability, trial CMXXSX example leading desired candidates believe of capable the particularly being next-generation vaccine entering the next is or vaccines. novel in of nine trials within COVID-XX

in high-risk and monoclonal that collaborations exist vaccines considerable COVID-XX worldwide distribution. program. regulatory current We for have internationally therapy. due and support both commercialization an the will populations interest We participating well as our focus anticipate to believe clinical partnering likely in opportunity on expedited an as of our by path antibody development unserved Also, domestically the and we

improved both of Gedeptin accelerating Presentations on Phase our in GeoVax yet processes. the conjunction Gedeptin checkpoint advancing expected year. of specific in reporting conferences of at further into are focus X MVA the advancement inhibitors further Our and CMXXSX. smallpox for programs, the progress and use efforts MVA focused We includes anticipate scientific clinical this program for preclinical support remainder related the Gedeptin and the information of XXXX vaccine medical and the monkeypox CMXXSX with various to development, to used in immune on technology update manufacturing

against vaccine Regarding GEO-MVA, smallpox. it monkeypox and is a

difficulty supply first intent and US the low monkeypox, critical based to primary worldwide, significant experienced expanded in be many related to especially which access have countries supply vaccine the supplier of Our based smallpox, MVA Mpox consistently or of and protect an providing is against to or vaccines. middle-income and

We are forward and this progress to initiative quarterly. advancing look reporting

time our were during capital firms at balance our feel investor Last success GeoVax. or and belief underway We people. XXXX, reflected sheet, growth a that biotech development many adding and has which we year programs support strengthened opportunities in of value of furloughing $XX million the

programs. receive continue our investment towards We strong to capital, will goals, XXXX and development evaluate, achieving interest which value on focused milestones we our related but for shareholder execution critical reporting strengthening we’re

to like Now recent our presentation for the Chief Officer, status. results Financial to and over Mark Reynolds, financial Mark? a I’d of review turn GeoVax

a that of we revenues small first note, we reported overview this reflective you, David. seeking for of our the our U.S. of in programs, during our income financing as compared our in however, government and funding to we I’ll grant and future. Army preclinical XXXX wind I’ll to mix are out a the from down with last actively an additional development be which statement. fever point XXXX, our brief grant the component expect no that is begin amount of clinical preclinical for important And I’ll non-dilutive Thank program.

as expenses activity of higher was increase and increase and programs. were is of also The we and up for $X.X development XXXX. $X.X with CMXXSX reflective planned clinical XXXX million in and our the quarter staffed first costs trial consulting million The in Research associated XXXX. and personnel expected Gedeptin versus during is

well were in associated costs $X.X personnel as the to expenses of million the ‘XX and increases quarter as million ‘XX, with G&A costs. higher compared with $X.X in also consulting patent as first

the per first ramp-up infrastructure increases $X.XX with with versus CMXXSX associated per the and So, Again, was quarter other Gedeptin primarily with trials. the XXXX clinical $X million overall, XXXX in $X.XX of or for loss organizational $X.X of net and share, the million associated share. costs or

in $XX.X in is the sheet, XX. at during December million investing to to compared million, significant first now activities or at balances cash of quarter. XX $X.X The operating used no as activities. the million financing change were Turning balance reflective cash March were $XX.X There our

at million. is obviously cash ongoing of the clinical common use our now most shares outstanding stand X priority. Our our our three XX.X top and Funding programs important financial Phase

opportunity this Our for David expected any answer attractive will activities, questions mentioned. I’ll the course We the investment the sufficient fund of programs programs to our period. milestones these cash and previously an is runway during year, to create be through happy fundraising occur new to of as Q&A the advancement clinical believe over

call turn now the back will over David. I to So

answer Mark. Thank now colleagues your and My questions. will you, I

Joining Officer, President us Medical session Chief our for Chief McKee, of Scientific and John Sharkey, Mark Officer, Business Dr. are Development Q&A respectively. the Kelly and Newman, Vice

call for period. operator I turn to back instructions the will the now question-and-answer the on

James, with Jason is Dawson line Certainly. your Kolbert [Operator Instructions] open.

we couldn’t you. about for of a focusing those Thank about but on of with having have They here. am with really for thinking their important I vaccine? question looking have One this discussions expenses are a capital yet? that company say government ago. conserving had the and of years you caught you COVID interesting what resources any terms in kind Great next-generation something something of what’s are what the clinical couple I is you and population, are attention ubiquitous they probably discussions them have job

the question. Gen thanks I actually in April it Sure, to clinic and the specifically the federal my the request a Next were clinic related protection, about relative your could that for Project to nine on were comments, Jason. This enter outlined looking that specifically is RFI government products during what what issued months. David they and durability, for was or and information And XX, for The focused of already breadth criteria. within stated

and So, – there are a are they that and breadth for as they issue, of whom the that recognizing vaccines inadequate. are is durability protection and populations are therapies also there out issue, an key looking current

what did So, then the submitted, process that no say, you there whom RFI that are well-prepared, it. I’d of all purposes, in or that they’re for we that providing you will going money to and they terms we out, how was information this much very very quickly, stage, completed the decide or go response with have those – to through laid is At for further which and discussion They information. follow-up for outlines. seeking

respond. we’ll we accomplished the for within that, specifically The to the how question, on shared process what on manufacturing includes with have capture now, and Next discussed et Gen. far and with with thus some May which response see government they to who been the of those address proceeding is interest. seem XX. are Now more Project on a them, we Ultimately, discussions review with had we’re that such time them have have recently having cetera, team, some to continuous We’ve towards of individuals to the that really have process, closed even some had ongoing discussions part RFI cell-line the and federal submitting

we So, right very for were still are very, different it, companies and prepared We quickly. submitted etcetera. now, submitting, again, our

and And part some are the waiting. are of so, outreach We Project various part of whom some and discussion terms in are only aware, individuals, our we have are an development, and making entities, where Gen they but this the forward with sure we are Federal we moving system. engaging government related who of plans still that not GeoVax, of manufacturing with are process of what are clinical already in of in accomplished, what new of Next

questions. So, I answers that hope the

also they are have have working sure we people. dialogue. through yes, out is are we reach other make the but to out answer avenues that directly also, working But we we the laid process also So, to through

if you. did I CFO’s David, it would they but touch sequence you months? earlier, out next just of can to the your Perfect. you you given don’t over know on lay understand just XX mind, Thank how the comments, like And mention milestones. I

Okay.

in have the now, this we X been the XX the FDA. last three to expanded the as you That’s XX-patient it, We Gedeptin, we had trial. for two with program. recall, of And that’s in by the So, sites. patients bringing one funded fully initial anticipate patients

about have expanded is program to yet the been with to this discussions we than the accomplished Our review data, the later, our in advisors that to would we plan that propose clearly year rather sooner FDA. have already

year the data, and to it we the this hopefully yet and discussions initial review to So, the anticipate data, discuss initiate have FDA. with

much. all so We you upgrades. appreciate Thank these Perfect.

you. Thank Okay.

Bernardino, Vernon Wainwright. H.C.

monkeypox. than a meeting your you did you month with David, that anything Register, other based and are of other taking were I to if is as intend is the especially really I just the Mpox lot programs. are could congrats such discuss well on – recommendations David, months be as made know, programs and candidates concerned, may MVA What is Mark, of to It’s immunotherapies. get things, the important wanted process, XX to have what into Jason, called such change and could A ACIP have wondering vaccines or far manufacturing for my don’t one for, the in help as the for the they Federal the see looking was it, and have Hi, near-term clinic everyone. as advanced with on to as my there your the X take, vaccine as asked formally you Thanks by your you next anything piece. question, future so there going questions you and as months? – next that

Thank you, Vernon.

is MVA developing am relates We is since and what but of weigh leading rights John we and aware I smallpox. that in-licensed doing, are to program, our the acquired not vaccine that we to in, on or anything he to are against Sharkey ask Mpox specifically John? agenda to that are going what

for the thanks Hey, question, Sure. Vernon.

and mentioned the timeframes. is have continuous we become MVA platform, switch scale manufacture based large for cell-line has our As – smallpox before, so manufacturer, quick desire in that the on eventually can we U.S. to monkeypox

that were get number mentioned, MVA is unable U.S. countries the or unable outside are Our regulatory access have were we that a the there to of strategy, still is as vaccine. – to

see there. market we opportunity so And a

is Our strategy right now engaging.

open putting and with to countries, is And put expedited pathway would efficacy confident around the and of whether we we that’s to an as be agencies we that now use MVA whatever approval, other together would recognized territories. and NGOs that agency pathway, going to We or get monkeypox that’s it the be us, biosimilar, available from allow known what consulting see with approval a smallpox to world that’s an against then given respected working will space. could together a in to accelerated well-known, referred a of use safety retained MVA is. with regulatory be group have their What that within this regulatory strategy have that outside are regulatory an

the we general we now, that’s are strategy. So, are past our Right information – the gathering. in

are to thinking, a discussions to them our We agency because regulatory the get would world. parts to to to to is engage work product need this of with many with now on beginning like in there accelerate and we we out about reach believe how market, them to process approval the

Thanks And that what further need the Western outside a as outside Terrific. for as get as U.S., World the might later progress information. announcing those year? on and things follow-up, do Europe, far the progress of making anticipate you kinds this such governments as you

Yes. be the It within two will definitely next months.

kind We our have reading couple for of with at the working a regulations now, and looked of months this of consultants.

proposed We have pathway be them as and they to them their familiar what a tweak them that to willing present might or how thinking would adjust to see we them, out or is strategies be is we mapped as that on with engage not work on. want well us we with may there

So, forward to phase quickly the with move the into regulators. is this engagement going

exciting. very That’s Perfect.

front. And Looking question. forward to taking news thanks on my for further that

welcome. You’re

line Kumar is open. Raja Capital, Roth with your

my and on congratulations Thanks for questions progress. the taking

they the you following are Gedeptin, on interactions can enrolling you. think follow-up screened there And arm which program, expectation do that in checkpoint be with more in the will expanded quickly the if than of patients expand how a Thank inhibitor? interactions, will a Just be by you XX those regulator, if will the include program, terms QX? you

some he the John status provide what to preclinical, on Chief inhibitors. may with want McKee, immune checkpoint to guidance going then Okay. Kelly? still I currently related Sharkey but Officer And discuss am is and to Kelly ask to our Medical there.

would plans to additional of regard would probably it If an Yes. whether But waiting we We I there XX think, really on reasonable the have people one front get after enroll do up Hi. our available patients probably that if if think I reviewed don’t of for but final furthering any we to targeting a are the add current a consider study, of bit willing or closure the then that. without XX opportunity two and open – identified an patients, of for have our are we have closed hit example, the enrolling we investigators not sort and delaying at would With get to this patients dynamics the data to question. enrollment. that, total think target I present continue it time, depend discussions. we the for of are or regulators of that’s in within study, to current our timeframe,

John, on the to some where that what and you and we want do ICIs comment learn? stands,

Sure.

– be said, in So, David still more, in of the Gedeptin, would speak preclinical as and Kelly think I it’s scheduling ICIs the open. is still can combination that it with somewhat to

right the as that’s But any how go animal humans on is there discussions we And be will we win what you suggestive, add a from point that, with to how discussions agency. between them, Kelly the there, be show goes dependent see with synergistic to I the agency approved the in the is decide would as At that. proceed. two. now discussion what because with have regulatory would patients, ICI, do that on to never what’s – other now to want that the is XX we could with with data the to think small very highly let how will see Our I actually the to a the concert always effect a have going you monotherapy. get from data focus to Gedeptin regulators insight Preclinical

Well, only that that very program. be sort of are advancement we to going optimistic think I this major a for is our

what to was success a with of where bladder mind, recent the that in they [indiscernible]. the conceptually we of many have or cancer, similar got virus concept and similar to in exposing data on ways some Merck with is in aware up – have which well are paired You sort checkpoint had neoantigens. oncolytic There Moderna inhibitor, that

are stages with for in the And us and this so, disease, we neck other types with target a think I head earlier approach. this potential of solid that tumor cancer as optimistic offers as patients well to

But discussions So, quickly to we as us to required the we for on there. to to move it’s regulators our again, are get as about going going this. depend with can what’s advance

Okay. That’s Thanks much. great. so

is Molloy with open. James Alliance line Global your Partners,

Hi, this for Molloy. Jim Thank our taking is Laura questions. for you in

for will the also be we might were completed anticipate Phase trial that in already previous trial When a Phase of enrollment ICIs should be the on quarter. to X/X soon then this this X/X the what of the announcement? So, following the last expected the mentioned the last like, ongoing on or question, subsequent patient top Gedeptin visit And patient for in completion of trial? determined expanded protocol look for or

Let five me just cycles. we there XXth have comment. patient the enrolled, are Once

So, months. five it’s basically

forward gives enrolled, then you evaluation XXth time we So, and then the then to patient on that that the of data. look the cycles a depending five when period through is

So, in we opened the come be on, XX patient sites in let’s are And mean the so no able cycles the There that’s are that and then upon may through focus expanded the hope anywhere to than results in that. mainly to less, the XXX year. look because there metrics, the determining with opportunity more they from to thinking therapy ICIs, initial discussions as this anything that add that’s be likely be able and is of protocol see But Phase complete we see. expanded basis less as this based what will point. an of will we which patients to again, at to I to patient data. three our the this five the if completion the to been with I that – Obviously, up on from protocol the review in, it when final XXth they has what when but we really initial is all. greater working think will successful soon be would the discussions clinical if to a And we this Kelly I and then along ask depending we move we are have trial. on like conjunction about study. combo yet if the come related or is structure, on depends see X just one at

that think much I No, pretty that it. summarizes

enrolling Just as note is the and terminal disease. straightforward as our simple patients their stages that not might Remember to it that essentially trial these appear patients on with surface. the targeting of is

more enough for going to take therapy six few other And between. to again, months we them months us their through, So, found folks. to that’s a all five order they six be months to to far study those of have have palliative enroll these treatment. and it’s in patients in or they less eligible exhausted – and that healthy of therapeutic find tend to be patients, have And to options, for

than strategies. get hard our are But trying as take and once to other longer inhibitor would to parallel we identified patients analyzed, fully continue of see had potentially a get with would this us the they little a see to we said, enrolled, discussions so can initially agency, checkpoint about But study this and combination it’s of for And to or we I to population what a and data bit as front David and have sort they for enrolled. anticipated. like a then us get in in also patient what as approach we our mean taking eligible like

We I will just to how go, to think. discussions have wait those see

trying data for it data move be sites, analyze happy we it’ll will that we reach been expanded the we eight the to then was now and the agreement the we to that We program, with and out full and are have be X, with X because by other them, XX. and Phase if big in encouraged that in get And need will trials. priority need you. possible, data as Thank of and the quickly but the expanded have on an – supported, also a parallel we and go to as limited Phase then sure,

So, we will keep you. you updated, Thank though.

just Also, more one Understood. question.

your new think emerge, well mentioned do moving it forward? as shifting for this So, this may and work development these also landscape in does for the against COVID-XX with way variants equally And the then newer for candidate, any CMXXSX as you streams? as change candidate

know T-cells until we have protein acids and more evidence is now. the antibody hopefully isn’t type broader, side and both where than concept of latter a the compensate and the and don’t some or can robust Well, nucleic we of testing, antibody we targeting spike The to done incorporating have it achieve for that to we T-cells. the of protection, more alone more sufficient less by that with the

Omicron, license had to at different. of And And current we CMXXSX, some in look and terms decide we because to again, alternate variants we that modifications vaccine, the rights continue so will that’s may a significantly be do what evolve agreement if we of they be have. added want also that we to and we to to recently related are it hoping to announce demonstrate. We the did that that,

populations, it we after populations CMXXSX. that much initial underserved to with that not thing So, modifications is vaccines current know the stay have that have broader by One is And immune that we believe the the sort data of we for very differentiate the And we compromised for discussed attuned the adequately just and or that shows been that. served by breadth the as of are we vaccines. continue to to authorized do structure going going heavily have seeing with system. those focusing before, basis are us of we that’s the are making the to especially, difference. with And a existing individuals behind provide on inadequate vaccines the

forward. will as keep we data So, you comes updated

Thank for you questions. taking Got it. the

Thank you.

line LeBoyer Noble Markets, your Capital is Robert with open.

and announcement of comments Thank earlier for the is Kelly still answer But my likely you. Gedeptin. question inhibitors with as the to and looks based And combinations. Well, more John the about are that on the looking and question what end about it you an quarter? announcement timing gave ICI very first come the I cycles a an the but of have maybe calendar, thinking? at if five might year, Is at the the good

on, obviously, have patient then evaluation just again when of we comes always the etcetera, Yes. map Robert, the we trials in, that – like length done XXth – know when just that it’s period, you on you out. depending

two from of patients he as can affect It these when terminal as improve are of everyone on survival of anxious everything. this is who we So, are anticipated last and really, said, not their therapy. to their patients period mentioned, this lives get But, we is have tumors quality as care. There Kelly during these palliative life are the failed in. type they as

Great. you very much. Okay. Thank

Thank you.

this back over There are time. would to at I to no call closing Dodd David questions further the for remarks. like turn

Thank this interest. achievements you outlook. greatly and you and thank your progress update appreciate in call participating We for everyone sharing our and

about focused and focused greatest will can on to enrollment, an the that, milestones data pace And talked greater talk about sooner, accelerated to development have continue database we results. Our CMXXSX, biggest other stay we patient and of programs to what see focus we getting are we on, challenge Gedeptin, is that’s so of today.

interest able GeoVax. thank advisors, stakeholder our a advise, you a that, asking want goal and some We other value, motivating for that development you all for guide again, questions, career Have be great who our doing our and including opportunities we staff, value, And great by to our providing a support, have your us of thank of is Our who Board will success. of been towards to Directors, you and course, achieving we wish shareholder in all weekend. this, team. parties, With evening. build continue to

This concludes your We today’s you GeoVax thank call. for participation.

now may disconnect. You