GOVX - Earnings call transcript Q4 2021

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Operator

Good afternoon. And welcome everyone to the GeoVax Fourth Quarter Year End 2021 Corporate Update Call. I am Chuck with Chorus Call and will facilitate today's call. With me are David Dodd, Chairman and CEO; Mr. Mark Reynolds, Chief Financial Officer; Mark Newman, Ph.D., Chief Scientific Officer; John Sharkey, Ph.D., and Head, Business Development. in be will participants listen-only mode. All Please Instructions] note this recorded. being is event [Operator like conference forward-looking turn Abraham would to I now the call information IR, will this of who over provide regarding a statement and herein. CORE Jules to ahead, go Please sir.

Jules Abraham

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

David Dodd

Thank you this IND successful year to for to resources XXXX We're thank X update quarter pleased the while opportunity the fourth end enabling immuno-oncology, programs. of growth afternoon. GeoVax development, have COVID-XX Phase continue our acceleration within call. critical review we you, Jules. participating while to clinical in Good And advancing in in support secure and and our development

the in with Phase the immunity next of through City we generation antibody CMXXSX Medical the Over year, past balance global exclusive status development the of authorized it goal Currently COVID-XX Center cellular license is of rights providing in Therapeutics both cancers GEO-CMXXSX National both Hope X the the advanced in neck from strategic clinical utilized protection and and durable which from to and catapult Birmingham. more licensing targeting rights in suffering Gedeptin. sheet evaluated from our licensed vaccine, Alabama, Gedeptin drug we vaccines. robust global a FDA. exclusive is immunotherapy received head from current in a cancer and University has of patients we orphan the among being PNP and which

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we this both related programs. IND enabling During year, clinical anticipate and and milestones progress reporting to our

into move let's GeoVax. So our programs further and to at discussion exciting activities underway related

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development XXXX of and beyond of executing for growth support we resources company. and further successfully In and addition, have upon our expertise the enhanced in our plans

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parallel by is with to goal Our the by In thereafter. - the be manufacture. filing of results of likely for the shortly prepare BLA a supportive, enrollment complete XXXX we patient to ongoing CDMO or with commercial XXXX. of towards the clinical completion end end program, also 'XX followed are patient early XXXX, will engaged happen a or evaluations Should

of team, We X are soon. possible outlook will Gedeptin with Gedeptin cancer. head this highly the successfully that confident the FDA operations of be and has our provided sites CATO the program expansion further neck about We're SMS by potential additional excited from managed for clinical within - just advanced clinical Phase and designation encouraging We're patients. orphan previously with promise drug received such advanced and

indications, updates exclusive technology us cells. the propelled development. entering a inducing the exciting literally Modified and with In MVA-VLP the This CMXXSX a is of in MVA worldwide to addition, Vaccinia In we CMXXSX. Ankara by We're virus of referred well there this by as other other National technology utilizes with therapies use Hope COVID-XX Phase of vaccine under stage as last announced license works immunity can stimulating to Center. SARS-CoV-X year, Medical produce This relative our SARS-CoV-X are vaccine forward to into throughout now as vaccine from of conjunction providing to GeoVax. about healthy and programs other of CMXXSX from tumor antigen potential X expanded development clinical the promising milestone year immune synthetic, synergy that of associated approach. progress Gedeptin opportunities which Gedeptin GDEPT block program. to looking to November critical our antibodies refer City GEO-CMXXSX, our typically as similar I to at transaction against system

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and elicits induce attack cells, virus the responses a and replication severity of design M specific is directly to T-cell protein and designed protein circulating vaccine induce response neutralizing an variants. to the infected clearance. SARS-CoV-X reduce both This and T-cell response the vaccine to M the infections better viral Thus, the for clear and specifically to regardless protein. reduce expanded implemented antibodies combat immune was S While

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from And we believe be because the antigenic using that also that respond prove transplantation as demonstrated such have investigative immune clinical to by being of benefit differentiate to or and CMXXSX vaccine. of undergoing severe and trials. this trial an the risk vaccines optimally One CAR- CMXXSX such the pre-existing the to COVID-XX will response immunocompromised to MVA risk or who current current with multiple is a trial vaccines. therapy various and approved a cancer strong at immunity due a Pfizer Phase status patients clinical T-cell more vaccine Multiple vaccine COVID-XX. compromised failed generation We their FDA are populations factor. with from two-prong currently COVID-XX individuals trials the high is to received will CMXXSX comparative greatly patients people approach. to response T will the severely associated We specific first to still potent there's therapies evaluated these X believe in delivered sustained reduced or such antibody providing suppress other high blood have that both are two believe

and vaccine believe of either have countries as for The a COVID providing well durable using that studied is boost is received robust heterologous immunizations fields fourth in are rather provide in response may a a trial currently evaluated We protection. booster multiple and other being underway more the Moderna, immune than such other who are prime HIV, evaluating third and vaccines. the Pfizer, CMXXSX same Heterologous shot healthy different vaccines. or mRNA patients booster, previously

recent working the internal SMS working clinical clinical oversee operations conjunction two management and exciting are in following the team. We these CATO to programs, of Pharm-Olam, with acceleration with and merger our

mesh with significant schedule the manufacturing effort on activities of are a AVM GeoVax transaction to ongoing to production with the develop the to [ph] and highly benefits increase a and CMXXSX GeoVax consistency cell the will vaccines. development CMOX growing time. clinical development Finally, program continuously to and line based associated The this capacity full the process potential

Now, presentation of Mark GeoVax's, recent over Chief Mark? financial Reynolds, [ph] like for of I'd our turn status results to to the Officer a review Financial

Mark Reynolds

Dave. you, Thank

as entirely for 'XX with in the program. And for NIH our million revenues Grant pan-Coronavirus from and COVID-XX down in were the Grant 'XX statement, revenues starting vaccine to for XXXX. to period So relate $X.X Collaboration the our XXX,XXX versus income

Army the that million vaccine While in from our the revenues supporting begun had XXXX. million Grant during Research $X.X and amount were U.S. of fever That's for down wind period. in from loss reason the to $XX.X expenses a reduction. includes which development versus the XXXX 'XX program,

expense costs with increase with and to following process license manufacturing agreement primarily accrued related XXXX increases increase for organization our here higher PPP year. gain we and $X City level patent related XXX,XXX, for The on Delaware and repeat XXXX, fees related or With included your to license net in in our interest in the a activity comparable of of share, our R&D of our trial and a well for debentures are paid is $XX.X a and $XXX,XXX fees, for capital in in as for with activity. related the early level of development forgiveness 'XX consulting franchise and with of debt XXXX. received increase our licensing, of our Hope loss includes a increase with $X.XX personal that preparing program, legal convertible insurance and 'XX expenses Coronavirus portion A the loan were generally vaccine Other tax, figure were associated based associated $X.XX as generally vaccine million contributing was fees, were large million during program, with raise. million associated both share, versus again, $X.X the versus $X.X to higher a COVID-XX that minimal income universal expenses associated or for extinguishment capitalization which during XXXX, clinical per retired Also 'XX G&A overall Other expenses per of annual activity. was million on the expense premiums, is our to to GDEPT. primarily license XXXX. costs,

now Turning the balance to sheet.

end at our at $X.X balances balances of generated in which reflective us end is past $XX to change million the of year offering by cash from The approximately cash [indiscernible] early proceeds of $XX.X offset XXXX. proceeds net million to $X.X used compared this Our the million million. in as of were 'XX stock

of During Subsequent the we $X.X year at of a this XXXX, $X.XX traded in an received the additional share. million million per warrants. placement publicly priced to year end private of also through January our year raised XXXX, exercise $X.X from we

So balances approximately $XX today, of as GeoVax million. cash of has

Dave. got license cancer for personnel have this associated we estimates to our existing we've priority fund looking X I'll And direct will of believe while can to And turn for be sufficient other of investment Now And new programs, plentiful opportunity to during not those new programs. specific resources XXXX. - needs programs, present clinical create increased quarter happy at say fees our back programs our our that Phase themselves. an fundraising time, call and obviously second We what facilities, support current attractive cash I'll answer three the is complete costs plan and into also opportunities questions programs, and the over any are cash but Q&A. and as COVID-XX, forward to immunotherapy, and the ongoing these costs operations the with advancement only don't business to we these now of that they programs provide cost for fundraising

David Dodd

will session and Drs. are the Head you. questions. Sharkey, turning Mark Thank of for John Newman operator My And on to I our instructions Q&A over now colleagues Scientific Mark. respectively. period. your the Business Chief joining for therefore Development answer call Officer the us I'm Q&A and the and

Operator

We begin come ahead. first will the Instructions] from Please Maxim McCarthy [Operator Jason with And Group. session. question now will go question-and-answer the

Jason McCarthy

guys. the Hi, for Thanks questions. taking

or any the XXSX of bit a Greek Delta it's of mRNA now, were you than there's could fantastic be with side looking COVID both variants. the we the and probably will And of because like the and again, more Let's program. alphabet, letter state at speak - other little in vaccines last not about start was there be with seeing broadly then surging some probably I variants know pandemic maybe more that data Omicron saw the the we year. on something the And and the you next or less desirable, that with

change importance XXSX the So now and than the that doing data, for mRNA? does different need of Omicron something just the

David Dodd

general, highly being to I'll better the from in to the served vaccines. get to a be be by of Newman ahead strongly are T-cells outlook their they This David as to system, durable say well Mark populations. there Jason. that I'd antibody, especially ask there among insufficiently elicit we we we start Mark ask to protection, pick to to how you, robust and for can't ones a know constructs more then as up I'll the predict letters existing so be. is Dodd. need Newman be and I'll both additional can provide protection. refer variants, and we your Thank will But we emerging that variants, share continue what But on immune able sufficient, clearly compromised that of need will based the have able and we fail Mark? But pick what who and is and risk Those here, up alphabet as high

Mark Newman

Sure, thanks.

you're to seen antibodies So, protein seeing, start recognize we've some that targeting limitations. what on alone S I and the world have the neutralizing is focusing think

this is a the based the domain, the right, So know, and are that infection part that mediates primarily receptor to interacts on vaccines impacting just that cell. you binding

but infections - mutations binding it well. so a new not with protect weeks immune receptor the had not well, vaccines, interesting, current We I as there Now, in know, mRNA primarily. against protected being generation that around it variants, previous the which they're the that's a World because ago, it's S they're conference protein, total generation generating mutating are Health the the you it's while just vaccines, is don't responses Organization participated current still the couple domain and, as

one So issues mRNA it first with it's was you circle, started. where way actually it vaccine. immunity, almost full that of into go out like of pointed and the They described. long-lived the come have virus the the course, being And back can don't that's was actually

broader These conserved XXSX year the conserved in been nucleocapsid, to Coronavirus. also need are we I've need that things to respectively. in focus a make the T-cell proteins. for responses a regions structural but protein, There's I to saying that on a S response, have CMOX M which Coronavirus, So the now the the and are and we the a the

is come world the to starting so And realize to that.

followed back different using multiple You while you know, is who a in of formats. to do you would measure work HIV Heterologous you remember the difficulty boost vaccine that everyone there boosts it, Those was accepts immune are and responses for how prime by product decades attempts will how design vaccine. vogue.

match. hearing you're and about what Now mix they call

You J&J one, AstraZeneca got the different in a get vaccine, go of get or know, you're an Europe. if J&J one vaccine, an mRNA, if go mRNA boost can the you it got the living you with if

know, going And the are of one seeing evolution both those and And so drives way world. need variants these for to aspects, current try you're kind you're products, holding being you the of products. medical generation But it. that the are a find if generation of approaches the you're using next of the into taken. flowed of Obviously,

BX, But then are using field rocks vaccines. boost in generation maybe interest Omicron vaccine is vaccines already you was mRNA and So and some got that designed it particular there, was head X, Phase a to broader now, in [ph] the the And BX. time prime There out response. existing induce the know, Omicron into cousin making next by Omicron.

approach. feel as a something variants, we logical so, not And David is chasing just that said, is

So does your that question? answer

Jason McCarthy

Thanks.

Mark Newman

McCarthy. muted you're Perhaps Mr.

Operator

Okay, on? to move

David Dodd

please. Yes,

Operator

ahead. go next with [Operator Capital. Shivendu come will Instructions] from question [ph] Please Brookline Our Seneroy

Unidentified Analyst

you. Kumar update. Brookline. for Appreciate Thank from Shivendu I'm Hi. the

on move the trials understanding with first Marburg Sudan preclinical encouraging with is to federal the clinical data. So of would programs, funding. My congratulations regards all, and that

you wondering Department USA or And or any was think studies. regarding terms the taking how programs of these BARDA from inputs I if So of further? the you clinical have Defense in

David Dodd

fevers, addressing specifically hemorrhagic the right? you're And

Unidentified Analyst

yes. Yeah,

David Dodd

vaccine Okay. all we Thanks. and we initially aware during sure. supported have Thank through - in our through and in been Zaire adjuvant. be of unprecedented forward in that's these dose. achieve for Ebola, models in the to you. moved testing non-human current preclinical single a services, our protection And the a that may dose I also. NIH any single use showed And demonstrated make Well, we that then with think products just course I with primate products, had you without a non-human currently those result wanted programs to of progress primate XXX%

- we in non-human you all the we in the have support We know, continued We basis. BARDA progress that is Strategic anticipate in the services, been with of our would would than dialogue and the with depending to potential, the about course preclinical the on tell. will from National non-diluted through Stockpile a clinical seen on if NIHs program primates that have believe that we've the move supported products of And discussions opportunity with had time outcome, progress it through be in funding. forward that's in more be that ongoing the to we've that the we consistent there likely and development,

anything? want you to do Mark, So add

Mark Newman

that you world couldn't when Well, know, - can get the add yeah, do hit, just testing. COVID the is couldn't to get you primates I non-human that, real

yesterday. has fully is we we analyzing on back schedule. data, down. back picked yeah, everything that that so slowed And anticipate And and up us But were

results sorts just is to track, like. looks watch all BARDA anticipate the what in of having everything We'll shortage the on But have contracts. we data test And seeing just back of come see this these tech year. different with through we're So meeting a dealing animals. fully

Unidentified Analyst

now In color to planning [ph] Can helpful. VNT plans? regards elicits with was this future other are MERS that both cell preclinical more some program CMOX This thanks. I to your responses with get and pan-Coronavirus for And models. Great, develop Coronavirus, like you

Mark Newman

Yeah, that, it's different right. in so so S remember the - significantly MERS, again, protein,

things we a the with nucleocapsid, matrix, uses uses a - the of the are those it's you process same the proteins other - and But virus And a like as coronaviruses. the it's at all the we're and an highly COVID. non-structural existing shared amongst different enzymes roll when the But lot different that of beta CMOX. receptor. looking doing what envelope, into it's targets, is proteins, very know, to can ongoing Some the you are DNA, program,

backbone, XXSX Phase trial. in is fairly because And that's CMOX is the So the now basically X similar.

of the animal that - from that rolling program but these want pitched enzymatic we we along. reliance it's protein, shifting to that's and and play – first. proteins know, have So you And our And activity, this gen necessarily neutralizing frame, expanding groups we CMOX small with lot are And on other next have open we goes construction involve, games holding you with But the a that the reading looks in models, again wouldn't sequenced where structural [ph] we're all proteins. It's in in because want. we that is highly at antibodies, Sappi if into the next all phase rolling like is don't S conserved one. start to we those, being S and making know, like non-structural and have - it. right away up product now NIH and or a discussed see protein because can the not either

was what from So it's compromised we would and know, we on to successful are going, year evolved. four track, an and the on you little rely it's bit it So more and targeting the on world the know, patients. else always program. immune what separate like and extended, two can is look how CMOX XXSX, which people We you has existing in seeing but a where still pandemic are Depending focused that's it's the add? research

really we're So at That's how looking future. the vaccine Coronavirus that. beta the of CMOX the is

David Dodd

that as we can say, was risk, - our that to follow that clinical the with that see because development protected development give that believe I we I add just plan drive a then Coronavirus are going address would we continued highly to even through current populations is with going protection along vaccines are evolve. immediately can and has we greater - XXSX that it not adequately the forward are at to will with further being the more

Unidentified Analyst

That makes Perfect. sense.

final program? one know, for will think non-human What of Thanks. primate studies you MVA-VLP to cancer kind Do sufficient regards be it with the the data you get into the Just you to question clinic program. plan vaccine a MUCX do now?

David Dodd

the cancer models. don't primates. into For Those programs, envision no, typically are through going tumor we handled transplantable non-human

And using established that, so we initiated another animal just MUCX human for transgenic the another know, mice you trial, experiment well one program, model. a

so, and in the you growth. you with transplant and And retard what in transplant there, by if do the tumor you transplanting see vaccinating, you you and tumor challenge can the is vaccinate - or then start tumor tumor first

So that's use a that's for type primates. you of could non-human no With study done the there's those. tumors transplantable for the

wait can't around and cancer. if see you So just they and sit get

other So others programs, way. we're piggybacking if that the are on those taking - involving done that's we're MUCX under That what is control, have path that picking gene. forward the

responses targeting aberrantly they ad situation about glycosylated there's body on immune where MUCX. raises sometimes carcinomas. own, history So its a no significant a responses immune against your it's And

are And one of so clinical of our have trials tested collaborators, University these Pittsburgh. products have been that through - there in been

and so It's and a moving then to been goal MVA the And already is we'll X the take X Phase how is something this trial, in be that's this. add Phase to that.

evaluation will FDA non-human put them. that deal something to a But no what and, safety products have looking great two for primates. study. approved initial us allow but That's together two of know, we just them you're So through at behind products, an not experimental That's you do cancer. experimental

Unidentified Analyst

question. taking Okay, great. Thank for you my

Operator

from ahead. The with come Jason Please Maxim go Group. will McCarthy next question

Jason McCarthy

lot what terms Hey, an subsequently on Gedeptin on are us I patients A answered. think of of touch those Can important. have second first give you add or third meaningful And think sorry, it their might cut in a related guys, really expectations in where to you progress? But XX cancer objective you and program update terms got patients head registrational? we a you you think enrollment many is, I for to are the COVID would the what this neck program? clinically be for even of be that would questions considered are this then And wanted and my how off. program, And it's what to make part rate? good question, XX% be know, to do response of the XX% XX%, line

David Dodd

you. Thank

would John you to Let me ask answer that? like Sharkey,

John Sharkey

last, there have a what of drug five Sure, on top patients as this far roll, And for as additional higher opinion the there's patients the trial looking at we sure. be been effect. to maximize this the would patients At dose, dose of I the a to recall, - for two to XX, pretty sort personal going different that, at the increase see, is of point.

in question, for Hopefully that's at because XX%, the But when We I would are be standard-of-care, XX% agency. to a to against range with putting the But the it. would on this your of this point that imagine it stuff together have we to probably end have initiate discussion discussion purely with agency that current the Jason. an stage. speculate I'd would be say, answers

Jason McCarthy

Yeah, to going XX%, does. with your need, successful, you And know, know, if FDA you has It's view. that you're a the whatever you. rate it XX% to not that said. you're was what Thank the response

we've actually that's for outcomes, a program group that similar is the would Gedeptin about good programs study, doing with regulators, optional and to combination with move those yet trial, and this that there, follow so Burke line out could seen first for with to be [ph] something looks the is few data a it a then path the Just a another to other that?

John Sharkey

agent, single mechanism action move a as head, For don't first it personally of would I likely given neck, - it's line. its will I - into think

I However, that also earlier it suggests with as move an happening. up of metastatic would inhibitors, don't versus looking inhibitors populations, model, at in combination checkpoint treatment personal checkpoint of combination you and just early with response mechanism and I this could my treatment state data said, stage checkpoint standalone. disease, disease opinion, for think action, a again that people use certain inhibitors. potentially other we're [indiscernible] personal - then would paradigms an is And on see the patient into could paradigm the That I improve given you - we've animal try with when

Jason McCarthy

sufficient XX, you would as is that yet, XX to possible as than the where they'll they've of want given seen more right we've need? for to that's only high not we've sarcomas but XX, seen to that that it XX, than trials for XX, low one some about more met it some anywhere as filing. approvals, have Is XXX haven't take like enough, you'd that less gain add studies ranged they as people sided unmet lastly, people people, regulators from the be or could with And be XX even that in to the expectation, than

John Sharkey

of is it's options, the expect trials treatment given the that was be But agency, with on see dealing In types other anything would for that the [indiscernible] an disease, end lower reality. what you But be would I the possible. these no have range likely you end would stage file most to of it's and that's they the designed, of way –

David Dodd

was - like than Jason for this at with XX patients X indication Yeah, top in that the more, on we're it trials XX in Phase the a total. by XX. Phase X what XX current I that more more held was by based following adding discussion, And the of that something - have. looking would we agency add, the of program, upon potentially the the we're that given lower We're than looking exceeding number

almost as were minimal double for, So number. and that the they that looking for be would a number

what had in is And indicated. and also that we number significantly in to have discussions. - increase of investing basically beyond previously what in number the engage been invested we're but the So

as more completing for up these So sites, beyond that's additional end we been - add and more who we expand patients we indicated believe the which But the focused previously our we're is what have of - accelerate this what than that will do year. enrollment, and number on than

Jason McCarthy

you the thank Great, for taking questions.

David Dodd

you. Thank

Operator

Dodd David over remarks. any go for turn the back ahead. our concludes I like session. This would closing Mr. conference to question-and-answer Please to

David Dodd

participating within Thank in you. in conference sharing And clinical call, thank resulting you, stage our achievements, milestone immuno-oncology. in everyone, both this development for

Operator

remarks. Dodd it David would me, to closing seems someone that else like Mr. Pardon give disconnected, has

Mark Reynolds

I'll evening. has pleasant finish and just it everybody saying by for thanks hope a participating off everybody

Operator

attending The concluded. for Thank you conference today's now presentation. is

You now disconnect. may

GeoVax Labs (GOVX) 10 Mar 222021 Q4 Earnings call transcript