Earnings call transcript Q2 2023

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Operator

Good day. My name is Jordan and I will be your conference operator today. At this time I would like to welcome everyone to the GeoVax Second Quarter Earnings Conference Call.

I will turn the call over to Gabrielle.

Gabrielle DeGravina

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

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

David Dodd

afternoon, support Good we enrollment the for patient phase GeoVax the Phase GEO X expanded have This vaccine in among in update initiation two announcing well as the participating third chronic lymphocytic next-generation of with patients call. Phase for as as the trials clinical clinical two this corporate CMOXSX, evaluating trial booster year Gedeptin X and thank of program, and the COVID-XX a you leukemia.

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

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

balance we and these government into business as and funding. Currently initiatives, progressed activities, development NGO sheet quarter, are our a non-dilutive anticipate we priority second to opportunities funded initiatives. further of result stock of strengthening the supportive During XXXX, and we each related

was conference Society from Cancer presented clinical data neck the Neck American and the in July head current and interim the program joint Association for on Gedeptin at and Research announced, recently cancers. As Head American

pleased targeted no or encouraged of patients. are stage in development the in definitely serious with growth lesions and planning of We We the limiting anticipate already results, majority we attributable next observed and clinical dose clinical the to adverse impaired the current the to program relative completion toxicities by treatment therapy. of this events are noting promising shortly,

cases there targeted and of and deaths. a of annually There need. Patients and advanced neck are head XXX,XXX Worldwide critical U.S. deaths. neck neck cancer XX,XXX the are cancers in XXX,XXX patient approximately population. new approximately new approximately initial annually head medical unmet suffering our from represents approximately XX,XXX and cases cancers and represent This head

with tumors significant compelling against ICIs combination promise potential combo about We used We numerous are and therapy later of opportunity Gedeptin as as the therapy excited tumors cancers. in year. various in anticipate of preclinical Gedeptin We foresee checkpoint inhibitors. such with as immune other as the of this conjunction evaluation therapies administering monotherapy, publication addressing of Gedeptin outlook and well

support for rights and hold We in all the Relative use commercialization, been Gedeptin have of collaborations indications. we anticipate activities for initiated. in partnering development business worldwide use to of which worldwide

various novel presentations worldwide. which Gedeptin expect of participating of within to array Increasingly, discussions. cancer approaches in we significant addressing vast are opportunities with oncology others GeoVax needs represents advance Gedeptin some The conferences, unmet for medical various needs partnering oncology and patient we

and whom the protection on current of in critically robust the high COVID-XX COVID-XX differentiates for vaccine than of generation the important and is more providing systems immune vaccines. vaccines therapies risk. current unable include disease, immune the at populations diseases the adequately immune both with groups with CMOXSX, approved to arms in cell as inadequate. respond blood from our durable risk positive, general, and such various next ablated lupus currently and to antibody are targeting mRNA focused addressing therapy. patient populations the monoclonal autoimmune GEO on authorized cellular vaccines anemia, vaccines such immunocompromised system, are This HIV renal antibody sickle those those individuals a cancers, suppressive Such In high

million COVID-XX support is million that the CMOXSX In individuals, approximately worldwide is XX a and such million. for This generation we XXX leading major in there there generation are clinical individuals, development. are critical U.S. vaccine plus vaccines XX to to immune estimated an need believe the next compromised next

$X House example announced The and quarter of Warp Operation clinical already vaccines desired vaccine. COVID-XX believe a variants of a against COVID-XX improved durability the novel protection seeking CMOXSX generation the is During follow interested particularly Project Gen, breadth initiative, candidates with vaccine in leading Next White billion in being second the We trials. Speed on from next enhanced

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

hope that we’re We NextGen, soon. and in involved provide process at Project we updates time all can deeply Regarding this say to further the discussions. is

efforts on Phase in remainder CMOXSX of into development and accelerating smallpox on programs the clinical support MVA our focused advancement X Gedeptin and MVA of processes. manufacturing further of the for we specific vaccines For focused and program improved Mpox advancing XXXX are our

milestone and pace We also anticipate accelerating support additional reporting of of to capital in progress opportunities add the a catalyst. programs these

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

Mark Reynolds

Thank David. you,

income during clinical David we and may We as of component expect the in mix had are important we however, will our our no compared for we actively suggested, development periods seeking I reported on a preclinical small programs, as grant funding the statement, XXXX. note this a starting non-dilutive I'll So very so of potentially for active figures the so that with XXXX. month comparative financing XXXX future. additional in far, grants and XXXX to our no be both amount revenues versus focus six

Research the and million activity materials. XXXX added $X.X trial and also costs reflective XXXX and of development which this manufacturing associated primarily CMOXSX clinical increase for to on trial in functions. quality in employees with million the clinical versus brought with Gedeptin expenses The were $X.X our for increase we programs, costs control is higher two executive year, as level additional depth regulatory personnel including

higher mostly in in million expenses consulting administrative million versus XXXX associated $X.X patent costs. personnel, and were with XXXX and $X.X General the with increase

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

our June the million the XX $XX in were cash activities. $XX.X to XXXX. compared sheet, million $X.X cash operating of reflective significant balance approximately now of balances no end There balance as million far during to change investing activities as or so the The is in used at of Turning XXXX. financing were

stand common at outstanding shares million. XX.X Our

our through trial recently sources non-dilutive for relatively most for providing top ongoing the fourth GeoVax four of cash Funding I'll initiated that financial with some analytical the But that use funded programs is is being minor CLO significant costs. Phase and our clinical our support primarily note being X priority. fully

sufficient cash through end these into Our expected of XXXX. programs is runway occur this to and to through milestones fund the year the early

David. turn So, call And answer Q&A. any happy I'll I'll be back the to questions now. the during

David Dodd

Mark. you, Thank

I will and now Our colleagues questions. answer your

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

question-and-answer the on the to over for I'll now the turn instructions call operator period. the

Operator

the first Noble question from comes of line Robert LeBoyer Capital Your Instructions] [Operator Markets.

Robert LeBoyer

on that the the congratulations made you've all and past in Hi progress quarter.

there combination and year. the to your has mention for data I wondering that presented the the a to any going with inhibitors, any be of of with question if was My plans was trial do rest or was checkpoint

arm was for trials but or the any had mentioned completing therapy intention expansion of potential another the what if and now? there combination right enrollment, You to was current is I start wondering

David Dodd

Sure. anticipate working in in to that the time, yet manuscript right at will is that? now conjunction you say on and year. therapy. I this be add We're any David. do that Kelly, to in of we published this want work, development. is supporting evaluation we're Kelly, answer work Robert. you else. manuscript There is not but and evaluate focused Again, right preclinical – that with clinic is continue add the clinical would understanding then our ICIs. Gedeptin in that to This guidance in current program. want What we're the of if I’ll it's that's work is, preclinical anything we'll to now And combo it, anything a this

Kelly McKee

Gedeptin really of solid to is is exciting I its solid that respect of one with mean about Sure. tumor tumor the mechanism cancers. action agnostic things cancers, essentially

And is inhibitor with opportunity patients. who with Gedeptin opportunity go and have in of sort again us head I expressed regard design academic But the I in an that in trial. investigators in have cancer are think in – will at of sort in you of of and And a so, for that survey looking we be neck cancer if of next we will in the breast of cancer And also likely early target in which think, interest Gedeptin The discussion. sort if tumor to combination steps different we the some landscape, proceed types. direction, we're discussions an early number checkpoint to space. phases a exploring the

that, to go target. and that non-agent on cancer but can't into our really going that's head neck next So details probably be

Robert LeBoyer

you. Thank

David Dodd

Thank Okay. much. you very

Mark Reynolds

Rob. you, Thank

Operator

question ROTH comes Capital. next Kumar of from from line the Raja Your

Kumar Raja

my taking Thanks questions. for

the about So booster a I had trial. question

In trial? this have when Will of data we from data interim data terms we this any trial? from expect can

David Dodd

the CLL Kumar, the about booster booster are the you or for volunteer asking healthy patients?

Kumar Raja

the about asking CLL I'm trial?

David Dodd

Okay. address that, to want you please? Kelly,

Kelly McKee

Yes.

enrolling still we'll is principal with Hope trial that six-month that enrolled trial at ago, just of study. of weeks The So the discussions it's in our on fully their a so based the couple early began the and have of Center expectation period. about City within the a investigator phases Medical and CLL team

is after after the vaccination, vaccination. is months the readout primary so a Now first month three the which or second

immunologic outcomes year, be completed the itself of time XXXX. question? Does early months after initial that do up think and outcomes to that and you're sometime end period study won't safety follow enrolled, – towards point of sort whenever math so is of I fully your it least XXXX, XX it’s see of at six, of outcomes an The a answer a for likely the so view you hits. So

Kumar Raja

say trying data be be any interim? these XX will you get all I'm Yes. for like waiting be the releasing like to in be will us us you patients from into out, patients some data you providing Will Or to What that? is XX let like, something or enrolled? update

Kelly McKee

operational remember progress as will again, specific study, this the proceeds, fully of answer trial investigator is the Well, informed so under forthcoming, can't initiated an data control is at this of this himself. to and that of And investigator trial I time. we are when be the as but sort

Kumar Raja

Okay. used then And being are Gedeptin the followed what also checkpoint? inhibitor? with checkpoint preparing the expectation and inhibitor, models the regard to kind use manuscript checkpoint the you how you'll be are sequenced is with there? Gedeptin will with And this like by of First preclinical

Kelly McKee

mouse specific prepared tumor not so the in And the collaborators. based Well, liberty disclose, is will work the on our a a their being guide of that, our it this academic I'm at trial. to is but of model mouse design model. details And by – clinical manuscript

some think with that you – can with we – say confidence. can some I

Kumar Raja

in accurate? and be models, well as cancer models is Okay. And will – mostly head as that's cancer that data neck understanding breast this my

Kelly McKee

in haven't do sure tumors I not I'm additional are. – from breast what exactly at have least know that, tumors, sure manuscript, put but is cancer data I'm there, I'm that being sure. not the a additional cancer they I so draft tumor model breast seen those what but not and

have Sharkey, you John do that information?

John Sharkey

couple a my They've Kumar, a is at they looked – Hey types. glioblastoma. they've different tumor Yes. of understanding looked at

the looked their which at cancer, of going see breast preparation internal aware, publication As a draft circulation in include current in privy the first time. not at they're and they've we within They're to to this we're institution this. said, just Kelly ones until

Kumar Raja

Okay.

to the And Okay. all enrolled regard you has the XX neck can and regard to in What with been patients with trials? head the share that?

David Dodd

confident that's No. going complete what be short is target of you're that We're a hoping enrollment want And I know end of very to of patients close we be to very, going – for reasons, to of couple is still We're enrollment? population a the out end target. variety This you at enroll when a we're by year. we'll before our difficult of to to really but take patient we're the – know place study this whole this a the year. to found be able that the

Kumar Raja

Great. Thanks my taking questions. much for so

David Dodd

Good.

Mark Newman

just weeks me appears patients that on of want but there's ago did to add, a initiation let couple the study be to Kumar, was it, CLL this. – already begun. of vaccinations point call I'll building, I a have recent queue announced there just It we CLL strong in it interested out

have there's a quite buildup nice So started in and vaccinations the the already screening background.

And because will is trial. months. go anticipation waiting six not I we concept fully through not till we full learning ADR enrolled the months as our the be of it six monitor it of and mean, data this being the be to investigator that within an it'll so And simply initiated completed. have does is mean pace we

Kumar Raja

Okay, great.

Operator

comes [Operator Kraws, Research next Your Instructions] question Crystal Jeffrey from Associates.

Jeffrey Kraws

much. very answered you of my Thank questions just Two one. were leaving already

Omicron COVID having died has T-cell in regard actually, some response down With other showing and given presented, the I the that the of as both response data variance CMOXSX an issues to you immune as is technology countries. the would a good Are this response? well that they're following think seeing while smallpox you and

David Dodd

through Mark vaccine Mark? all in because XBB.X.X, to seen Omicron I'll Yes. way this, on Delta, very Newman the but if ask like basically would encouraging weigh response the and promising, with against we've

Mark Newman

you, sure. Yes, David. Thank

We have time. X, in real we the the have call in samples the and we what safety cancer studies the in or from freezer Phase are the then evaluated lead in sentinels blood that

the where Delta? it against And Omicron? does and so and work it How work how samples we does you Wuhan against always well, back okay do and things your is it look of ask, one go did the against How started? work at

say cancer this has at would what a of responses antibody And the This couple Omicron great fact, and patients. in getting vaccine through original variance the And treatment we're in booster including some includes the expectations. responses the X.X. that into I Delta neutralize surpassing in meetings, is BA.X.X finding increase been the about Wuhan fact, in and from initial presented that of we're an even and omicron,

the to behind. new to neutralization very I behind the it's takes would constructs And we're and It maybe up, at variants. course, epitopes S not we're of the a always was is is portion both bit, we're recognition as So little promising say data level. but much three across the because high other varying maintained antibodies four that weeks long that make T-cell seeing seeing as varying to the predictable it's these and the a to the virus that That N recognizing. T-cell actually

the So yes, it's in pointing all right direction.

Jeffrey Kraws

recognized, it's in populations XX Now with cancers, the cell not as the, The such United estimated cell, to – well India widely cell sickle population in XXX,XXX. than the at States sickle the less as the cetera, while population was is be million. et blood on looking various sickle

not an interest lot So population is but a because for market lot them? you treating partnering, I that of only area it's of think such have for interest large a a patient for

Mark Newman

they're inadequate. normal for to with these and mask, monoclonal saw the are the but we who response populations Numerous we – medical a sequestered populations. are rest of know booster United like, true. the our – us these call strong world, being initiation They're barely about still sequestered there vaccines CLL immunocompromised And parts sequestered I'll we're the they're it are leaving; wearing have for that's back interest of whom a seems going other being within CLL States we are still indoors in the That's not the being the it don't lives, people conditions People not groups of remember kept – announcement the the antibodies even lives. trial. of current who and and patients, why whereas

Jeffrey Kraws

you Perfect. for much updates. very Thank the

David Dodd

Thank you.

Operator

the back further over the like There at I turn to to would questions are call presenters. no time. this

Mark Reynolds

everyone not cancers, broad-based in learn just products. you there's think data and in We application about our areas. about but show comes as Thank for opportunity quite you. in other head and and sharing We're what promise outlook. learning Thank the and you with The neck and in is Gedeptin encouragement, excited we'll this update in keep progress as that. more more of these to continuing we achievements, corporate and we're participating there updated

terms as what forward interest from that CMOXSX it. at the updated with vaccine encouraged thing various and supplier probably and supply, base the the the as about the you our highly the our we've We're MVA opportunity, keep et as then course, manufacturing promise progress and broad help we same vaccine a we'll Mark looking And product process it's the Newman U.S.-based become shook, with parties and in data more of exceeding Again cetera. of to comes we're world improvement. in such expectations first to. mentioned received of use of

you keep updated. we'll So

focus is to milestone accelerating on Our catalysts. these

and goal seriously. motivating acknowledge as support, us and for shareholder We'll while Our take very vaccines critically build the development parties that immunotherapies Directors, advice, who and is move to our to value and Board deliver assist our to we to team. providing and of opportunities many forward. thank highly counsel We career needed our other stakeholder staff continue

questions. a Please We if circle further you. time, and interest. your Have good appreciate attention day. you back for your you thank have Thank So interest.

Operator

today's concludes conference call. This

disconnect. now may You

GeoVax Labs (GOVX) 9 Aug 232023 Q2 Earnings call transcript