GOVX - Earnings call transcript Q2 2024

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Operator

Good afternoon, and welcome everyone to the GeoVax second quarter 2024 corporate update call. My name is Alex 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 Max Gadicke of Precision [ AQ ].

Max Gadicke

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

David Dodd

Thank you call. second you, participating update Max. corporate afternoon, GeoVax quarter Good and thank XXXX the for in

your CFO, addressed. questions our Mark update and comments, then of our Reynolds, an be provide my Following will will financials,

trial, of be $XXX vaccine, our our BARDA CRO partnered NextGen included vaccine our the trial, during is financial CRO an CMXXSX GEO-CMXXSX, next million, our with several mRNA award, Mark as Phase our to patient for with major valued Allucent FDA-authorized to comparing COVID-XX both development review. We're GeoVax, trials. clinical by led will the almost Allucent program billings quarter Project Gedeptin Project initiated a existing having is the XX,XXX supporting generation The underway, further vaccine. This discuss supporting delighted as already already our IIb and at in NextGen to events in BARDA as second the

or reduction stabilization Phase the decisions on in represent our activity other of the plans progress progress, well during immune CMXXSX and advance tumor the In These Phase process. implementation cancer. Thus neck squamous the a with far, Ib/IIa clinical patients with QX, conducted evaluation deciding II expanded therapy review in as MVA II advanced with a significant comprehensive GeoVax. Today, proceed check as addition, including provide to has Phase we therapy plans Gedeptin trial. an as the we'll programs, manufacturing in Gedeptin conjunction and Gedeptin advisory X Gedeptin for inhibitor clinical development with events clinical to to trial of status, and in an trial of head Gedeptin related for combination such evaluating to our Gedeptin, committee cell discuss and clinical of sufficient milestones support demonstrated updates

worldwide. over a year This advanced and XXX,XXX U.S. in population cancer unfortunately end-stage Phase in and targeted of December, head in Our the develop We neck pathways. important enrollment Gedeptin expedited cancer. result vaccine, establishing are and cancer is represents medical distribution. Last patients. partnerships goal unmet those anticipate and disease each announced therapies initial business pursuing represents as neck care die we support among This registration head the indications to development, for of of innovative the XX,XXX trial Ia/IIb and infectious successfully that of initial addressing needs, who patient collaborations worldwide and commercialization, critically support individuals closure who

with patients supporting evidence clinical including in stage earlier Our obtain goal is to of disease. advancement therapy, this

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Q&A the session, expanded II the further During discuss Phase welcome plan trial. we our to opportunity the for

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that and is provide more robust vaccine from a health-friendly believe result variants response a the practical, public of immune-compromised multiple COVID-XX multiple virus both addressing durable against that antibody Our immune our aim offered individuals monoclonal antibody antigens. This is whom the distinction as first-generation This and key and induction virus vaccine with We than therapies achieved are for the the a in vaccines. vaccines. represents vaccines stimulating first-generation important CMXXSX the to the critically by across immune current of of this system of approved high-risk arms typically differentiation inadequate. and populations is the cellular between the

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clinical in evidenced array In wider fact, research current studies these of and The provides distribution. award as additional of initiatives meaning highlighted to award a clinical the are HHS increased partnering and areas. thus Phase protection, by encompassing efforts variants underway vaccines. in a authorized release of from COVID-XX support specifically our collaborations that press the far potential. Relative current data NextGen potential for commercialization the announcing in the broader our this our and is potential that and anticipate Project than for we providing worldwide durability CMXXSX, and II Active supportive vaccine

execution this As to the of with provided delighted operational for and recognize study. partnered both ensure IIb successful critically we this Allucent mentioned GeoVax trial, funding and BARDA earlier, to Phase to important we're Allucent be

populations As trials X underway X Phase address with which are you immunocompromised the CMXXSX, of recall, II high-risk clinical of patients.

time, among as prior while session. as vaccine millions further mRNA but successfully to the of conjunction booster questions also won't tens this the in addresses welcome we a evaluates specific receipt our an COVID-XX have our needs vaccine current the vaccine of patients vaccine demonstrating Phase that of more adults durable The during used hope any demonstrate I may heterologous robust, our II Q&A you following with at other into trials trial we among these vaccines. booster delve vaccine. Overall, a immunocompromised mRNA healthy unmet

II clinical needed and important of increased. our that significant vaccine Project for and to our With public CMXXSX the in month related progress as our believe and Phase award NextGen COVID-XX collaborations the last worldwide. other critically armamentarium the a of health promise partnering activity has We represents part announcement studies,

within remainder markets. that the basis opportunities discussions provide on achieving anticipate a are negotiations. In expanded of areas we During patient advancing business commercial focused addressing and continued and differentiated XXXX, summary, we for development leadership

generation confident delivering also or and disrupt into smallpox, value suppliers. such or shareholder step that the us Our unserved national leadership therapies monopoly stakeholder chains focused products U.S.-based of sourcing U.S.-based over-dependence as we're sentiment to against significant governmental provide our interest. We're current differentiated important in a to such are existing on vaccine currently and that initiative improve providing favor supplier mpox and versus by on the important clinical that stage on remains vaccine. area, products, is The non-U.S. to GeoVax CMXXSX, focus lives vaccines. GEO-MVA, may current build This a and on patient major strong populations course due revenue while critically Gedeptin legislative and in worldwide. our will of the interest significant supply in a underserved candidate a intended initial first

both vaccines to revenue to Finally, related produce U.S. manufacturing stakeholders. Gedeptin, and these we needs, unserved an annual advanced care. We're enable effectively pleased perspective, these in I'll of healthcare, a of potential shareholders of confidence and significance for for outlook feasible in collaborators the underscore conjunction to our with need and the GeoVax, we this and seeing important adds current expedited billion. believe results process with products. From critically anticipate of a to standard need. Overall, our represent stage a that encouraging we're $XX GeoVax the providing commercially. Expanding to address of registration have this lead the rather areas and these that a important represent medical but and relative to Moreover, critically sales our market over to MVA MVA-based underserved to areas forecast, clinically we CMXXSX, by largely to targeted MVA opportunities products, clinical the from basis or partners various of product worldwide reflection continued distribute estimated isn't consistent real-time commercial our response are studies. products paths updates

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

Mark Reynolds

David. of XXXX I'll period statement, on you, focus figures for our versus XXXX. the my comparative Starting X-month Thank comments with most the income of

During first billing the to revenues the reported comparable award. reported quarter ended on BARDA June Project XX, began This the revenues associated BARDA with were under no which of our during NextGen XXXX. XX. contract, we June There $XXX,XXX represents

XXXX, of compensation X in XXXX of expenses with contract, with XX%. $X.X or associated and little for in trial representing we an personnel invested due costs during money So in directly balances the mix of as were worth cost of This expenses administrative of and primarily manufacturing trials, with through versus clinical incur. Research increase representing increase $X.X time income associated of a stock-based This is was $XXX,XXX $XXX,XXX supportive compared million XXXX, were decrease XXXX costs versus reimbursement million mostly correlate will including some a $X.X in months lower clinical billable year-over-year income as a there's cash development future conducting expense to to $X.X well. Other more studies. General XXXX $X.X month reflecting accounts. revenues well materials, expenses million so market is billing XXXX, and XX%, lower lower million than cost in the or a interest half incremental our $XX,XXX roughly as a there. first million, as our other the net primarily

the in net or net million $X.XX $XX months by cadet trial with the overall X per driven and was versus for and clinical Again, activity. $X.XX the approximately $XX XXXX per So first of and share CMXXSX or share. being million the the XXXX loss loss increase

$X.X $X.X and transactions $X.X compared Turning by used with million million in accrual some balances. at to reflective partially sheet, June in now offset $X.X buildup our balances together as December to XX, our financing the payables million cash of at XX activities, in balance were million operating

additional which sheet an also see. the with in current net proceeds We not July balance million, completed $X.X reflected raise is of you in that

Our outstanding common million X.X ] following stand the currently recent [ shares at financials.

the funded mentioned, Project to is Allucent, BARDA second support over event years. GeoVax top awards to quarter, $XXX NextGen federal operational significant program terms expect, award will for forward our $XXX that fully and going the priority in David But partner. The by during the and this and was between BARDA As we through program several clinical million million the it's CRO most total, the next total of entire our focus.

foreseeable significant most the clinical of terms for needs, In to of future. funding Phase Gedeptin cash II our our programs CMXXSX ongoing continue in will the non- and be use BARDA the

developing to period, collection call happy valuation questions during through be to to any back these currently answer over our plans the I'll fund now the next the Q&A formation points. I'll several David. programs are We turn capital and and

David Dodd

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

doctors Officer, turn Medical Chief the us McKee, of instructions Officer Joining call President and you. the and period. are Business question-and-answer Mark Q&A respectively. I'll for the Kelly Chief over Development John our for to Newman, the now on Sharkey, operator Scientific Vice Thank session

Operator

NOBLE For our LeBoyer Capital we Robert with first Instructions] [Operator have question, Market.

Robert LeBoyer

And on year. all in great the progress half of congratulations the the first

variety a the that neck, solid of of in was tumors. a was in and that One carcinoma cell squamous trial was the is of things mention there cadet the mentioned and of head

So wondering additional planned else filings you any if us anything was was could indications on IND in that preclinical I there or tell there.

David Dodd

Thank Chief okay? can Robert. me to for Kelly? Robert, me. that. I'm people conference hope I've hear of Officer, quite while, call but our I Medical to McKee, you, hear can been anyway, out ask a going the you address Kelly

Robert LeBoyer

earlier, a I you're was Yes, little clear and technical right difficulties but having now. some loud

David Dodd

there, Okay, I did we were and We that review And Gedeptin some checkpoint the April. and as Kelly initially some the and guess will so the because determined difficulties. Well, our next for II And over is study approximately, with I still and of head clinical be of the Ia/IIb. neck decided the this, had we advisory with cancer. the but will advanced XX the missed and target over this patients. first technical X/X we -- end combination then protocol, with be it committee will go -- Phase that then our target inhibitor, studying study I Phase Phase neck the cancer. through we've immune it be those in finalize approximately with the head It'll recurrent at

is Right proposals announced. we it the look also focus also is trial triple-negative with have we any also towards at recently interest we look as now, our we been advancing stage and Phase at that others, Now, receiving those breast cancers now. cancer, not II earlier of on or really

the applicable what we a which anticipate as are technology, Gedeptin technology. to long is do as the all be week again, the of tumors today's as, that of therapy, last announced for I as solid long needle was we they're will accessible, think plans virtually But variety it that.

prepared your enough? of II that protocols, that that the have second, towards we've we sort So to bit the development manufacturing, this of focused of we'll the a But third forward as that among as already end trial. Does we're the both planning we the year well so activate next internally all questions our get right be late interest activities with now, initiated, as oncology on beginning well of quarter answer quite moving maybe advisors. the of Phase

Robert LeBoyer

accounting of gave was me I yet? going And some hint on the be for. was from Yes. funding details $XX the ask could it a was that to or I as is if hoping the treatment question. Is great NextGen been accounting what determined has to if million those? second ask just Or a the too to answer, the That early any

David Dodd

ahead. Mark, go you -- okay, are

Mark Reynolds

We're revenue. this Yes, that. I'll reimbursement a cost as answer program. It's treating

bill personnel the benefits time, incur a overhead rates. for and So for some as the slight markup we that and as we study we external the for BARDA expend fringe for cost with

revenue costs the incurred are recognized. the as is So is when

XX-Q that June XX. project the start we filed, for until So just the didn't

amount billed month we a June. so of small And the for

I will does our through the not we statement, The think at CRO. that to all. but [ money in income that But reported to statements $XXX,XXX here financial the ] over And is time. the billed in big CRO. going value goes directly the money flow the that's

see revenues. that our you in won't So reflected

Operator

EF from comes Jason question next the Hutton. line of with Kolbert Your

Jason Kolbert

right. you're David,

about through. estimate, way You cut about, I would X/X the a out of

So forward. were manage what financials BARDA cash in this, discuss to the kind pro to of did BARDA I understand nothing And going statement. a kind want today, I really cash saying. you're of right? burn how on understand. is And everything the we and going you to of you is has kind hear of missed forma income pass-through terms the do just with the

David Dodd

you Mark, want to? do

Mark Reynolds

I'll Jason, Yes, address that.

fact, but just web's for mean, this. of some available went still technical the stream did I back flipped or the of difficulties have here slides don't down if In live where reason. we I is some stream some across-the-board in to I kind not, cover the know

in flowing. revenues just I the for as from contract. money the And will quarter, I reported answered anyway, So Robert, the with we start $XXX,XXX said, as BARDA

In of July the fact, [ month ]... for

Jason Kolbert

my Well, it wasn't question.

sheet. of how cash BARDA the of So Independent balance really the BARDA. I outside I the perceive award. asking on about spending really balance right? of And the BARDA, you wasn't was about asking kind

-- bit you you're pro are your what ballpark a how be today, run receive current the company of So balance sheet cash, But of tell year? what and have plan over little you're thinking spend. what to on going the in you the from about is going terms forma just the to BARDA, that, outside whatever to me coming

Mark Reynolds

BARDA that need clinical trial, plus is raise ongoing we're obviously line bottom trials because and the doesn't a and cover corporate going with the given, planned ongoing, to to the burn. That's we've our and the for okay? other Well, programs got other the the BARDA Gedeptin funding, overhead even money, contract CMXXSX

funds. in or we yet That's that. the say and liberty much how at to be all We're timing of will how raising So development. not

can BARDA for We program and that significant are speak, by pathway say bankers them what I of that one a flexibility to at that the CMXXSX, discussions with for in the in on on complete is least to several But clinical different gives spigot other programs. regard. turn some off, funding so

Now fast as efforts. be to as fundraising going still that's we And but of dependent want to be availability resources can, on determined. the that's capital we the accelerate obviously, and to

Jason Kolbert

I would actually I with you would a such price was fan something But [Indiscernible] that, what if one depressed wondering debt really was dealing ] not securitized you. BARDA BARDA Have financial impact fundraising who a equity, up of considered award other of I have really did you of Mark, companies approach. offering, is flexibility going did and you stock what new a that know with it smart. asset where can -- big for That's some We you They a was open of that was, might levers except still think of a there I'm dilutive more debt? I terms less But [ a I'm right? or instruments? the all raise noticed your my the in be

Mark Reynolds

issue debt is in Well, with to circumstances. securitized. yes, understand is word debt I'm The debt and that where okay, issue the The with we not mentioned right opposed you now on I we for taking I the have now. are have --

if or done hamstrings strategic securitizing convertible not a looking to that's where unsecured of Okay, at form licensing really way you're those. have debt, is a opportunities your built some on that's in then that your -- assets with if sometimes then you're I'm one are, debt feature you you're whatever, get asset. fan -- for patents. there. that, lien corporate and And usually at And we you But outside some of one -- looking

Jason Kolbert

timeline feel -- to you'll don't [Indiscernible] develop, of able already feel terms comfortable with represented you've the of kind you that in you do in you're getting the But to continue be adapt offers and

Mark Reynolds

compounds being really going Yes. we've right we're Absolutely. a the stock is communicate reflected the price. environment I think there's market that. I the have still it. weather that mean, think the we're in assets value challenge we under to crapper is through communication to in And got I the of current But just that and that not the now

of to the And lot think here. a We I will upside programs. continue the find funds there's

Operator

line next Your comes Kraws with Research. Jeff of question from the Crystal

Jeffrey Kraws

with basically using call. thoughts aspects And the will your that going have to had your on and sorry you do things. questions your think say asked ask, on many that I although been does not was I because The I technical that debt difficulties limit to the I financial concur ability

trials wanted time patients? hear to On on with recruiting, other hear the Gedeptin, that you cash allow it's complete think And to that will lot have when product forward easier your conclude? CMXXSX with speed I great time and your the this. what And wanted also. on funded, an will to move is on do but obviously enrollment? those it's the competition attract recruitment development, what to that those you but given that do, just its or the your on do Obviously, that is you anticipated timing raise it is your back there of the with And you that you a programs, the thoughts think throttle does cash

David Dodd

on? Kelly, to you address are you Would that? like

Kelly McKee

on. got I finally Yes, back

that cancers that. have briskly. fairly sites the been X we that received talk Yes, of patients -- to with have -- the about so ongoing X have currently active, so recruitment about transplants, with cell X have we in enrolling trial blood Sorry which

which continue several we to to here we're sites put we've they've Now, projected state. enrolling And intend preparing planning briskly, trial activate But in is the involve launch with patients the we X very, pretty sort been trial much year that to couple this a We've and additional context. a discussions an very into what discussions while are serious month, do. next in sites groups had over over probably to of we them have have to for opportunity a U.K., that you been follow-on And trial, -- -- we've are and enrolling the patient Canada, will international clamoring there about in for U.S., follow-on study, with that the which to U.K. The will who patients. enthusiastic be -- participate that trial. about in they're the of

So with regard to year sort get the of within and of projected recruitment challenges, time into I next think current they're we next as the trial X. role going the the to diminish sort over trial or mature

David Dodd

And Jeff, David. this is

NextGen Let Each in the estimated that sites X there's me there going are XXX project XX,XXX-patient to just been add, Project each trial. relative vaccines conduct is NextGen, provided trial, have one to award. and

and on are, completed already the we the a XXX there and just So they our on and we competition We for for thrilled fast is behalf. currently there's the us on process. additional adults, at this But moving patients. others, confirmed made that a there's lot will have how there they're month haven't And sites, out a go of XX, what, are the signed ones, announcement but so healthy confirmation here think that well. We're And June of been this. identified XX to sites half past.

year, And fast, -- of I say whatever will from about and delighted an think it least, is. X will enrollment are I Allucent, things be it's we're incredibly and the that is Kelly, very take the more of So pretty at which that. go anticipating basically, the could not we that thrilled we're for But going. this months, pace following start and to fast, see, off is others this understand, to that a it'll that for, I successful program. what are, we're nicely,

where is, that also. it and So help that's you may understand it

Operator

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

David Dodd

this We Okay, quarter participating you as QX our progress, NextGen in thank proceed our award expanded a for that GeoVax watershed development and the Phase believe an trial. reviewing the our result past outlook. you. clinical decision a represented Thank Gedeptin today's in achievements, everyone II of with our to and update, Project

greatly look interactions. is we interest appreciated, Your to and forward ongoing

competitive, As we development continue and providing success. We're opportunities also thank and and disease developments. We're the the to paradigm many partners GeoVax. those including contribute of for GeoVax us highly who to the of want career parties, of Board current underway seeking disrupt most and our vaccine to our towards and and Directors committed support quality-oriented to continue always, advisors, cancer individuals other therapy entities proud to staff, team, meaningful acknowledge external at that achieving progress success infectious appreciative our to

For all serving team. it's shareholders of us, a and this of part our being great pleasure

cancer Our our overriding and goal of is needed critically you. therapies to and vaccines. Have and improve infectious lives commercialization by worldwide development novel, disease a safe enjoyable Thank day.

Operator

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

now disconnect. may You

GeoVax Labs (GOVX) 6 Aug 242024 Q2 Earnings call transcript