IMNN - Earnings call transcript Q2 2024

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Operator

Good morning, everyone. My name is Jamie, and I will be your operator today. At this time, I would like to welcome you to Imunon Second Quarter 2024 Financial Results Conference Call. [Operator Instructions] Please also note today's event is being recorded.

At this time, I'd like to turn the floor over to Kim Golodetz. ahead. go Please

Kim Golodetz

good and Thank morning, you, everyone.

Kim Imunon's to is LHA. Update Welcome Quarter XXXX with Second Financial Call. This Conference Golodetz Results Business and

periodic regarding believes about on call, expectations identified forward-looking are by today's management forth based filings as of number the expectations from and may in be current and including Commission. similar the be those to differ company's forward-looking During can and expects, expressions. such Exchange anticipates, are statements will statements and risks can and other set events. statements be future with uncertainties, Securities statements a materially projections forward-looking actual statements. words In subject or general, making No Imunon's These such guaranteed, results

that accurate during content except call Imunon of the by the date undertakes conference this or law. only made this revise live to of update caution broadcast, XX, is the in comments no call, I August XXXX. required as also as obligation

With Imunon's Executive like that Tardugno, to Michael? to call over said, turn Chairman. Michael the I would

Michael H. Tardugno

Kim, everyone. you, and good morning, Thank

take your We concerns. is question, opportunity. Gaiero, following liberty interim to Financial I and time to replacement permanent remarks, Lindborg, a to questions will there this CFO, Officer ask Executive we your retired President words for you you prepared and point to over our to We're Church. to And the just the this that and happy our use wanted to Stacy to Jeff be our time to, few respond to questions, us. say have encourage Chief and seek a if Officer; before who just is turning David a call as Chief for our

your can company I report fundamentals, the On sound. is that

and recent and strategy leadership. second that The Lindborg's weeks give to to Dr. and testament quarter

we few our These of know, a in our study change with little outstanding. years. options recently are women over very II IL-XX I data from unique outstanding, very that topline cancer. given reported IMNN-XXX, seen that, Phase facing you report has that a long-awaited care can candidate And As study our XX unequivocally the of standard in from word, past results the ovarian

am In the expenses deal quarter Stacy this you we've on past as outcome, comparable the tough, market. terms attention, despite seen remarkable financing are and promise our of ovarian has tough patients. with a future the for capital the with company, refocused challenging progress I I reduced recently, company's in hope over that its investor-friendly support IMNN-XXX and this has cancer truly closed streamlined that delighted

to you President a with trust left her Dr. the remind she she during asset, for of the has was was our and I company a in the it you decision that to of as IMNN-XXX, quarter, that second Lindborg development Executive the difficult much appointed will strategy. a hit lead similar ground with Imunon. agree she that company's also sure very, lead very I'll and I'm believed shape me Chief that that position running.

turn So over the my Stacy. now call it's to to pleasure

Stacy Lindborg

Michael. you, Thank

time over and patients. Imunon treating fulfilling last our of in Imunon I'm real As the in of the Michael as physicians the by to difference promise a of the the closer and further I community been and comes an months has has emboldened few it making exciting the team. talent see lives indicated, in science dedication in

cancer. with and for role We're treatment in me play next by Imunon's are to motivated we women honored that ovarian chapter. advancing of ready we Let you, assure the the get

we U.S. in Phase and ovarian may the is a effective immunotherapy alone with a weeks, more time only study, cancer, disease more II in women the This our you Just cancer. topline as from ovarian with each and that X than XX,XXX for every new first globally of diagnoses data XX,XXX reported the and million treatment short leads couple diagnosed have our that X.XX we a about year. of year, a to ago, than OVATION in is know, trial the cancer deaths terrible hands,

dosing refer with review patients, a open-label, an just of biological a XXX IL-XX neoadjuvant IMNN-XXX in as of combination trial before of the for take being chemotherapy, is randomized activity often moment the of and I'll study or to well-controlled, addressing IMNN-XXX to the plans. is localized OVATION evaluating briefly it. cancer. immunotherapy mediated our treatment ovarian advanced safety, evaluated administration DNA intraperitoneal NACT efficacy we X

fallopian IMNN-XXX diagnosed administered in ovarian, NACT drug meter tube with to addition including or up standard weekly the of We're received arm design squared disease, cancers. newly doses per compares to and studying the alone. peritoneal XX to trial randomized of XXX IMNN-XXX versus our Patients treatment milligrams in primary epithelial, The combination treatment naive patients plus NACT of NACT. care

to relevance pivotal the now clinically Phase intent-to-treat by with an month a So extraordinary survival. translating improvement III in which a all the following: population meaningful have the is including in our in XX% -- improvement overall overall improvement we survival to trial, IMNN-XXX in standards disease -- difficult ratio with which XX.X contemplated disease. a or to difficult-to-treat This have hazard measures a findings,

of X demonstrated months. dose-dependent survival signal the to is XX the population. of IMNN-XXX improvement X. was or OVATION doses, was patients For a survival remarkable XX% to receiving This we overall in XX therapy, the with with specified in overall consistent XX% for standard saw close and in exposed the improved this patients benefit that was PARP by Furthermore, inhibitor in of potential median care a more intent-to-treat of clearly

in which months care to reached ratio treatment been the survival the the dropped IMNN-XXX overall not had X.XX% data yet For the median standard arm hazard the of treatment group, compares arm. the overall median and time of the in this at XX.X of with survival lock,

critical -- Regarding to align our a align have to taken our available next with steps, needs and of conserve our steps we critical funds. number capital

us end an end of conclusions of of several X depend quarter We of this our data the means FDA cancer the permit will to begin including are meeting of and point, first within meeting expect topline access to can end registration at pace with This validate factors, we on FDA study in to ahead. clarify this this and X the the recruitment. Phase an phase fall, X study study we XXXX. of ovarian with this and the XXXX. are our will Phase for targeting path But The readout at our days requesting capital patient

IMNN-XXX only As you X with study in cancer. know, is the not ovarian OVATION

The fallopian that or study diagnosed of Texas disease, as of NACT. cancer, University Kettering Through Anderson with treatment. at foundation under is IMNN-XXX an We Dr. by enrolled the ovarian X bioequivalent Amir leadership minimal peritoneal the have Cancer ongoing and is Break be have residual or proceeding principally by second PI, funded Avastin on Memorial date, evaluating MD Sloan cancer combination with Subjects and patients the determined look to Center received study will included. newly and MRD, Jazaeri. study Cancer primary when laparoscopy administered tube been in And Cancer

assay. harnessing DNA insights from insights look X. patients a for endpoint, levels pilot first have conduct ctDNA you We sharing the Dr. this from tumor OVATION to forward data a now will next-generation few circulating test following study primary to data Jazaeri treatment and with using the reached As this

Switching our vaccine for now the study to DNA of I candidate Phase COVID-XX. proof-of-concept

partner. discussed second handling that past the vaccine, a attractive we pharma calls, with on logistics, a quarter, believe generated enrollment we've a During began booster as seasonal preclinical efficacy which and IMNN-XXX superior we've patient COVID-XX make we vaccine with will this the along to

is complete Phase seek by plan to And end the point, at of development. partner continue the will actively that report to Our year. data I we a

our CFO, quarterly over financial for a turn Dave Dave? to the Now results. our discussion interim Gaiero, I'll call of

David Gaiero

Thank you, Stacy.

in we second Details in opened. morning XXXX today of which our the this filed market release we press are before results Form the Imunon XX-Q, included issued quarter and financial

As from of million proceeds the receivable. accrued to XXXX, $X.X the million Imunon June quarter, approximately XX, Subsequent of $X in received a cash we registered of close interest net direct offering. in investments had

And into Stacy our third of cash on XXXX. strong to indicated, focus and have extend to spending runway our prioritize the we continue expect will quarter and steps taken management. We cash to evaluate as

quarter reported net of share XXXX for quarter $X.X $X.XX $X the second quarter second net quarter XXXX. the of loss compared the were loss second million from per of second of $XXX,XXX per with of $X.X X% for of million decrease expenses XXXX, of or a Imunon or Operating XXXX. million share a or a the for $X.XX

internal of partially offset capability in quarter compared costs of in PlaCCine by due of a were $X.X million in of $X.X quarter produce our with XXXX. decreased to quarter DNA. expenses XXXX. program in clinical of quarter plasmid primarily XXXX the second decreased with XXXX costs the compared year million ago. the with same second $XXX,XXX associated establishment costs second were The to regulatory decreases XXXX. the compared to the compared $XXX,XXX of a were of CMC XXXX to CMC in second R&D quarter These the period $XXX,XXX the Costs lower to and increase other $XXX,XXX by second

Other with the $XXX,XXX $X.X expense Bank facility. loan in $XXX,XXX this attributable on in XXXX incurred in period employee-related XXXX on of partially with debt fees to was in its the the a of the of nonoperating XXXX. second was administrative compensation Silicon period XXXX full in of The the decrease of of $X.X compared by increase $XXX,XXX, XXXX. lower The compared were of second in same income and expenses of million $XXX,XXX. quarter other nonoperating noncash Valley extinguishment second of legal the in quarter company $XXX,XXX and of of stock General of expenses quarter million loan with primarily upon offset an expense repayment facility $XXX,XXX loss same

half the first compared increased half in $XX.X half million of or PlaCCine XXXX, $X.XX million first million and per associated in to half program half $XXX,XXX the of XXXX. financial with $X.X loss period to $X.X the of $X.X half of million first company compared in the Costs in net a results XXXX XXXX. first $X.X of of a to same $XXX,XXX half the of million first with increased compared of $X.X first in half offset CMC first The of the decrease a $X.X share XXXX were expenses loss with share These other costs the XXXX in briefly million net the the by costs XXXX. Turning of clinical of period per were increases reported compared to in XXXX. XXXX. half XXXX. of first in for to of $X.XX first to the R&D in million Regulatory the the or partially compared XXXX same for the

$XXX,XXX. of half compared million in XXXX. first and administrative $XXX,XXX, the was of decrease The XXXX. legal of insurance with was with of expense the of first expenses the XXXX $X,XXX expenses $X.X attributable period General period were compensation and of to million in in primarily $XXX,XXX, expenses the $XXX,XXX income $XXX,XXX same nonoperating $X.X Other noncash half lower in of employee-related XXXX compared of expense same

The the the Investment first half $XXX,XXX expense loan same debt company expense of for interest half in company's by decreased its as of the Valley first due facility XXXX XXXX well with of with lower the balances. XXXX. from of from as in $XXX,XXX associated income investment Silicon short-term incurred period investments $XXX,XXX extinguishment to Bank

financial that to back call Stacy. the review, turn With I'll

Stacy Lindborg

smooth retirement. thank and very Dave, you It's stepping you, following Jeff's so been a Thank seamlessly in transition. for

to As highly historically, at-the-market of Michael each added competitive sold. balance of X per operating $X. The proceeds price financing warrant cash in additional terms. warrants at approximately for this announced a share capital gross is mentioned, over with The $X brings that was million under share X.X an priced This our million, runway. a which to deal included we $XX recently in well a our have $XX.X stock quarters June

and consideration Before catalysts, capital which initiatives of bridge important further we a assures conservation discuss. to can

and ATM discussions partners. our we access including care the ability interest going of every confidence and investors, have in to with capital our health many possible use premier from Following our forward,

hope together that shareholders, lives. and to mission you'll I have Imunon will we bright that our future is patients' that agree meaningful of a the impact deliver with on on

up open your to like Operator? I'd that, to questions. call the With

Operator

question from H.C. Instructions] Our Wainwright. [Operator from Emily first today comes Bodnar

Emily Bodnar

you're study, talk the that a funding thinking raise to on additional can OVATION given think about you've evaluating kind follow-up maybe of you're you III such came strategy strategies and a study gotten X cause? large expensive of and Maybe looking to of just out? comment partnership capital to pretty made. you're for those data other financing how tend studies? And you potentially Kind discussions be potentially Could any about how financing if that since or you if could obviously, a Phase you some the interest if

the discuss on you you're to study booster, I accrues? the could see And for able as then if data and the of second, COVID the blinding it Phase kind

Stacy Lindborg

the you to I for you. Yes, so with And want Emily, thank then, add Great question. both hear Yes. it. to I'll questions. may think you to Michael, start from

that order $XX So cost trial on this could we're anticipating of million.

million the takes adding into as us actually to cash XXXX about well it really takes So into the sheet. $XX quarter. with we third balance And our very us talked well runway,

business to a have core able provides trial raise And with Our is start our time the us additional then to of course, objectives. -- planned. our that to be really manage continue goal, for -- for as way bridge capital. the achieve we really we to We're with this to our intending allows this us company and

you Michael, to want do And additional... offer

Michael H. Tardugno

always during can across the and that mean, say the I for number, financing unequivocally that a companies recent cover Emily. I we're I And roadshow, spoke of question, quality number a best. spoke the small think across number to know you positive. board, the we you capital, good this challenge, among probably investors. think to a overwhelmingly But board, good we was for micro-cap very days maybe Sure. except to quality reaction And of very the in investors the I It's particularly and that them. of raise a

may tell see Market things, to to their more conditions, a have is time the other that most data. little more But think the from I this limited recent financing story roadshow They maturity. interest. with like among bit

the catalysts financing. give will is reengage opportunity that company think additional looking engage opportunity provide an and to that round to an to strategic some forward meantime, may I consider partners ATM, use us successfully. another the the reengage or In equity

and of this many ovarian this don't the go patients I been has seen ours, the think, support. kind impact the that companies on the the whole, data without cancer of the will and important On study financial history honestly, lives from like that we've of

Stacy Lindborg

trial. question the asked you other Emily, And one about

are micro open-label that catheter preserve of of an we this I the trial So be an is this environment, intending with more control for only would also arm for through we a to for directly the as be into the route being could procedure. really study that understand an that, to administration to the decision tumor all ethical think would way have line you require which be unnecessary surgical Imunon

on intending So for the and we'll this out FDA we are get be will buy-in appropriately the be that in full label. that agreement And to with a there plans endpoints ability certainly open trial. report event-driven will

Michael H. Tardugno

talking was I think she vaccine. the about COVID

Emily Bodnar

Yes, sorry.

Stacy Lindborg

I apologize. Okay, misunderstood.

Michael H. Tardugno

right? So you're results, to going batch the

Stacy Lindborg

for So the was IMNN-XXX, question? that your

Emily Bodnar

Yes.

Stacy Lindborg

apologize. I

an So trial. open-label it is

that we really, trial immunogenicity end this interesting data by of have expect the and we with will exciting -- the are very are do have be the year. of part We what to

course, batches, them the really, able but to from based have discussions. sample that in proof concept, will So it really we're on be to the and we're partnership And the can the do expecting seeing. effects full up establish trial report set to we'll we, and of of out

So full stop.

Michael H. Tardugno

evaluating DSMB -- In is the the is meantime, for safety? being

Stacy Lindborg

That's right.

seamlessly enrolling trial, I to trigger where being a that data to patients per the study as an through of of the DSMB Phase planned release continue, So gone have and approval DSMB reviews, regular treated. reviews you're exactly plan. we would a getting in We've is multiple ongoing, you additional expect, have needing our the

very well, very, moving very it's efficiently. So

Operator

comes question from Capital Brookline next from Dolliver Kemp Markets. Our

Brian Kemp Dolliver

study a you to not they When waves the COVID are say exactly Just of quickly on were years is ago. plan. couple enrolling what XXX.

that are enrollment? spike case So see similar as you a where the seeing you'll this we steady enrollment? Or spike fall get a is the in potential into COVID, with in

Stacy Lindborg

Yes.

this study So subjects. enrolling is healthy

the that I been about dosed. they've numbers running and that's trial, patients XX% quite and we're the in very enroll look it we above reviewed regularly, will of XX at -- have and center experienced a per them We I've the

think season likely don't I it. flu So to influence the is

In expect the trial really be in fact, ahead of observation. it terms to of likely we the completing and

Michael H. Tardugno

also. I'd comment it to on like

mRNA there there durability. I formulation not demonstrated to in depending that be said, will as this an for this be boosters. believe is the study, of Phase -- replace manage So handling of global the opportunity And may be the to a are that that temperatures data, of That characteristics, of very we distribution. mean upon are friendly vaccines be would I lot the that which number advantages least course, a

but point provide important can this of other you outcome some, concept out, the proof is vaccine more As from DNA the waning indications. the study a think market is I that in

to And you may speak to... want

Stacy Lindborg

to in that. to is make to to potential study I oncology discovered We Yes. sure to But choice of would viruses been strategy conjunction to that there we equally And exciting the we we want likely path, The mean when there's technology you for very of quite think there's target down who's more choosing and it. a our that enormous pathogenic be add vaccine. maximize think were decided I'd what party guys with technology. aware, our to partnership. think a really develop have than need I like do concept through XXXX. an would about value the we in are thoughtful going the core even as of our there establish since proof XX we

exciting itself, many very, Thanks Kemp. the question, is very technology So the reasons. the for platform for

Brian Kemp Dolliver

the you Are And stand? and the timing set given design, data if And that two do strikes request you you where been clarity II can end XXX when together. the a anticipate and that you presenting not, in on Phase it? it to meeting? that having trial for those position able then process, have Because full does events Phase the X expected your me around of dovetail

certainty investors. going You're lot the have a in partners eyes more and of to potential

Stacy Lindborg

able Yes, the expecting those announce full -- we it's the to at And will be have are great we major which the soon as as certainly data present entire in question. fall, we a to plans. a set stage

in we of as ultimately, in X line of are within remarks, -- lead we Phase terms days much everything very the in with look study as align goal, meeting. end are dose we're doing at that I in We all my prepared which shared requesting And patient that kicking well QX. the off, and will to really first steps up of the extremely with our

I So and describing around synergies some there the others. be do as of you're expect well will catalysts as many

Operator

comes next question Our Bautz Zacks. from from David

David Bautz

upcoming So Stacy, trial about I some you're was most important factors alignment could hoping wondering meeting? that are what come Phase if the during with design maybe your talk for the FDA X you the of to into

Stacy Lindborg

treating David, women inhibitors. table design to a believe are we synergistic -- question, been looking leading have Yes. careers with of input with potential out with a effect ovarian effect what very the great is that's the we study, their from that motivating Coming cancer. see not with certainly certainly coming forward we're clinicians really we only PARP to and tantalizing dedicated to that but Imunon strong X this synergistic OVATION

likely genetic very arms PARP one there's may the predispose HR BRCA treatment thinking a nature -- the have with mutations, with in balance for that that strong the So is very response aspects mutations that a in of treatment inhibitors. of about across a ensuring likely carefully deficiency, example, we're women that

can these of bring answer very treatment entire the study sure across certainly, So subgroups. key evidence addition that key we in to to want than strong make and a clearly effect questions we

endpoint. very endpoint, be the straightforward. I definitive So We're the think, will primary choosing

be We expect very discussion. that will smooth a

is consistency overall and the -- endpoints OVATION are data we're the really in giving which in the factors into the Key are the up are us those and which will primary very the Those top inclusion of which criteria, that list clearly indication really we're So of statement. survival set X. mind. confidence design key of including then for establishment first-line a things seeing the

David Bautz

Okay. Great.

you And speed anything to is that regards that be there with pleased can in up to is going? study? enrollment study, Now how the are kind of enrollment MRD maybe done in

Stacy Lindborg

done internally. yesterday team, rate job had reviewing was it's great out question. patients have phenomenally, it's competitive. in It X managing and that now Yes, even X to a have our actually of sites. the It's just of XX. so doing What of than but we -- this treated happen study this with X, MD a while turns enrollment higher OVATION needs phenomenal has I we more out we right Anderson is

Sloan be is will on now Johns Kettering So anticipated soon. Memorial Hopkins board,

into So see entering the to I think sites are them meeting and we study. patients with fold these as can come the now increasing expect enrollment and into

this the that their really certainly X they they're do, at that meeting our we'll what is are that I fingertips that and recently terms has can data counseling sure describe these with need out making product think of to in meet potential we'll really each to OVATION patients that of criteria. enroll what the PIs the they armed come of be inclusion of very women with of

are So very we pleased.

Michael H. Tardugno

have to of at some the We year. the information end report

Stacy Lindborg

That is correct.

of the translational by is, bit I biomarker. very remarks pilot come study. I interested talked study about think, lot out planning the also very looking some tumor end at interesting our will interesting little rich of So Jazaeri, PI, only a opening is of on biomarkers, this. this and the circulating He the worked year, a of in Dr. is of but a DNA, that data not

on that sitting the of second the year. we're able and studies. really to laparoscopy look looking the with being at data endpoint waiting passively, pilot we to end primary endpoint, before be then do So release And expect of instead

David Bautz

to just it you're going to just the look is vaccine clarify, like positive so partner? company look to advance for partner that to And to program. results is it Or that platform the is XXX, program? going Great. to if sounds that to whole Okay. with the advance But COVID

Stacy Lindborg

Yes.

the platform. So partner entire would to we look

are very open. We

Operator

from James Molloy next Global Alliance Our Instructions] from question Partners. comes [Operator

James Molloy

it program in reshift and question PlaCCine to thing. sort I XXX the looking fair -- rather of shift PlaCCine had back Would maybe on say Z and a preclinical the could you're development forward? the through PLXX partnership imagine and a And open be as said environment how there's than whole looks to the partnerships to general the immunotherapy in well, PlaCCine? a you you the to I the DNA well, walk Should perhaps going you focus for plasmid how please? those well. walk looks present, immunotherapy currently And through as opportunity for you're then can for vector the as that partnership environment partner

Stacy Lindborg

for Yes, James, thanks the question.

that think wonderful looked joining an always and I our time offshoot -- employee back at the platform has focused Imunon strategic reflect of adaptation. a a really been very a if we the a company. from my And I CEO, perspective, PlaCCine before on an highly on it's right? technology, the Board as So as IL-XX

to what funding ability strong the transformative into then And -- opportunities our and choose to core partnership. really as rich look options decide can bring to We business, non-dilutive of the and also will we gain business our as well what forward marketplace. we have terms the in for for furthering we'll continue choosing drive to

us wanted really So several that's technology, study, -- not really to I COVID-XX. a bring was think this we've and into launching I of do for clarity to. for get there, to years, about it but that been vehicle the we think the proof-of-concept something the potential for truly was talking This

intent my in. coming much very is that So

we've fact, our the in last that we're really In internal very ensuring able effectively allocating to and quarter. aligned with resources and in very priorities resulted with our that accomplish being clear been

some I partnerships, do remarks. It may on that to think comment premature Michael be offered but

you -- be focus. to and calls, motivation is right hands strengths compare potential, but there be we We just with current and to the on in some that and right to highlighted think the options, the I just future the are it are an needs overwhelmed with very thrilled there highlight amazing if have certainly we'll

Operator

be with today's over that, turn we'll concluding And I'd ladies the remarks. gentlemen, closing question-and-answer for session. floor and to to any like management back

Stacy Lindborg

thank to Thank for you you. participating really this call. in conference And everyone

to pandemics a the go work months. clinical progresses studies that flag ovarian And women our potential I'm increases, also population's will prerecorded providing being very interviewed cancer upcoming we excited about reporting to ongoing fireside live data exposure I As with chat in in options of in the the on and one-on-one want from which that to meetings X And the remain you Wainwright for putting we'll can be will start out are be available New Conference, X end conversation. information Global a.m., Investor H.C. that held the XXth the for Annual so at be that We'll virtually. those September conference view interested, in York. at

and forward So for afternoon. you'd Wainwright if informed you a a look like you meeting. H.C. contact progress But keeping our we of wish to nice Thank you joining.

Operator

We do joining. for And ladies and today's thank gentlemen, with conclude presentation. you that, we'll

now lines. may disconnect You your

Imunon (IMNN) 14 Aug 242024 Q2 Earnings call transcript