IMNN - Earnings call transcript Q3 2024

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Operator

Hello, everyone. Good morning. My name is [ Malone ] and I will be your operator today. At this time, I would like to welcome you to Imunon's Third Quarter 2024 Financial Results Conference Call. [Operator Instructions]

to call like Golodetz. to now would turn over the Kim I go Please ahead.

Kim Golodetz

good is XXXX everyone. Alliance you, morning, Thank and This Business Conference Welcome Imunon's and Advisors to Kim Third Results Quarter Financial Update Call. IR. with Golodetz

or differ that comments also number making words call may will and future Imunon anticipates, similar except or such general, X, call such and as to the a risks expectations the undertakes over obligation forward-looking and the date Exchange call, In are including statements regarding President of set conference this Stacy can and said, Commission. be this are by statements expressions. to November actual based the those turn law. With about of statements other to be uncertainties, expects, today's Imunon's on current forward-looking These During company's and call, be accurate the subject periodic events. required Securities Dr. No of materially forward-looking as Officer. caution only forth Lindborg, update would to Stacy? is as in XXXX. no Executive management that Imunon's of can revise the filings results I statements statements. I expectations projections with identified by believes like from Chief broadcast, content live made during guaranteed, and

Stacy Lindborg

will like will Q&A. financial noting both Interim to Kim, are our Officer, following Board; review by line Scientific Michael Anwer, I'd for you, David Chief the my morning, results the of begin Chief everybody. on available our executive our Khursheed remarks. our Thank Financial and and and good Gaiero, Tardugno, that Chairman be Officer,

the oncology, results involving in diagnosed randomized marks ovarian overall cancer the punch new the improvement and has year treatment. our XX.X XXX first milestone and OVATION from to an care, meaningful we This with ] large survival, exceeds the announced not for but a large set study Imunon. research. clinically to start X achievement standard cancer advanced groundbreaking Phase which a randomized with in On potential study a July only improvement XX, II me expectations, [ median a newly Let line in compared also of standard nearly patients in an unprecedented unprecedented months, line

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receiving planned Importantly, months. patient population for survival doses, XX% particularly XX These that witnessed the at are remarkable increased significant those in outcomes least by not a a of has IMNN-XXX years. first extends an in context. OVATION the More is ever XX for frontline improvement X in to therapy over study lives advancement overall demonstrate survival this an patients' which crucially, in

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talks, or I well and You be it listen to will your attention. the target entire specific promise can program worth

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same translational diagnoses report OVATION such trial Furthermore, Phase year. cytokine that in new technology and biomarkers We sufficiently TheraPlas and consistent. such benign truly in was XX,XXX about FOX the consistently study shortly. In demonstrated to deaths results On along treat than our immunosuppressant the Phase more I pricing saying difficult the ovarian Phase billion for registrational of $X.X III outcome, are a year. population PX, of Board managed. unanimous The consider clearly showed proceeding PD-X, unambiguously there We've desired the blockbuster each know patient works. PDXL [ were and through been unexpected. has is Scientific that cancer safety commercial unmet with we X very as intervern-gamma In other a the decreases women data outcome X.XX more a terrible with easily diagnosed the the studied that a a Advisory our in all globally we Scientific II. increases meaningful million every recommends and The geographies not far clinically with territory. market data the U.S., prospective expect and suggest as was summary, in assumptions been unwavering. unequivocally opportunity are is annually, the which and accomplished that anticancer and OVATION trial support exceeds our and as translational high. The strong and note, to greater U.S. X, XX,XXX with remarkable ] IL-XX dose profile the need to IDOX. and Phase disease Imunon-driven product than in trial support Board II This data the from Advisory is cancer IMNN-XX levels,

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oncology a want that our Harvard L.J. R&D University. concept approach pioneered study Wei of just Day Turning at for I the of as across highlight presentation statistical method treatment. for to evaluation studies. methodology specifically endpoints such by Medicine Wei Dr. comprehensive to statistical information a this a our We England significance. Journal the applied in of Dr. with of more published journals JAMA, the combines New and to moment,

time had short and independently the suggest curves, under overall from If survival, approach calculating information on analyzed curve area to a by X you of the And ability that of average the prioritize you're the the unviable added Phase ovarian analysis analysis confidence significant IMNN-XXX X survival this in reduction be findings cardiology death. time, two end cancer, Dr. Wei's evidence us of also OVATION and statistical is true data, be effect. His in observed OVATION p-value in has used cancer likely Dr. presentation. that successfully driven to I the replicate X.XXXX. in analysis both result progression the and [ showed OVATION under progression-free lost additional with would curve combining in been studies. Kaplan-Meier ] events the area [ He other Wei's ] generating provided cancer treatment and which due gives to III. effect His X a

Interactions an them end the proceeding IMNN-XXX? So before with month. of the agency meet respect FDA are we we'll the and have for Phase well the to with of II advancing are meeting, the with of where asked development end we and

in the are the quarter agency, to and the Assuming begin Phase track XXXX, our III capabilities. trial remain we carefully an on registration with we of identifying requisite agreement first

are years with candidates advanced planning the and of very study include we guidance carcinoma patients or women X histological protocol newly Phase overall expect are but age least ovarian III II. criteria. it, that's Stage the and Philippian are XXX trial expected X, Included of diagnosed final course, survival, primary Phase from IMNN-XXX similar IIIC FDA. of cancer or that score ECOG with The in design X will the in enroll primary X Group to evaluate peritoneal and to criteria the likely we for be by the endpoint to As Cooperative approximately evidence will that with at XX finalized a tube with epithelial is performance chemotherapy ovarian will of or Eastern be neoadjuvant of

goal disease. ongoing with of evaluating the Dasari be to determine impact tube update and we're this for by residual study potential MRD provided diagnosed principally flipping Center as advanced both ctDNA peritoneal determined now combination booster positive Imunon vaccine. with or and proof-of-concept is is Avastin treatment of is in a using let's the Center to was recent pilot MRD the the eliminate MD Hopkins trial and IMNN-XXX plasma will bioequivalent [indiscernible] or test peritoneal and And cancer. administered tumor Zone prognostic endpoint Kettering as disease, is when to first Anderson conduct IMNN-XXX's following R&D The patients Cancer recently investigator, in this treatment reached study, the Day. have laparoscopy, by for second-look worse to a that clinical early study may patients utilizes at Amir PlaCCin ovarian cancer funded by topics, I Avastin circulating is platform In University. to on understanding as turn Dasari cancer bioequivalent our able of ovarian, fluid and have in MRD, as Dr. the Foundation, Phase DNA COVID-XX newly added NACT. levels or on primary study [ MRD, to studying determine seasonal principal An IMNN-XXX, which ] study Cancer outcomes. Switching the including Now study sites, Cancer study our impact next-generation Johns additional subjects an Dr. assay. recurrence which few The a now Breakthrough the Memorial minimal the MRD

we treatments on track year. completed. study, now the XXXX, platform quarter complete to handling participants Phase our During end I began superior We believe and before along of immunogenicity second in differentiate all data vaccine report fully data, the of which and the with of is and logistics anticipated PlaCCin are the enrolled the enrolling the we

platform. right efficiently vehicle partner, of We demonstrate a for a an partner instead new concept directions. than this COVID, with can to forward Recall, to product move a will on intended activities exciting viruses this seek development. serve pathogenic ] that as was trial have BD in is continue kicked multitude strategic the not more in proof this but the XXXXs, off since of vaccine actively to discovered proceed a XX [ and to

recently, report have our Vice appointments IMNN-XXX, as capabilities. address we Vice up from Kristin Phase been enhancing at across considered two and at our President she strategic gear and and Operations made data IMNN-XXX Kristin Most two to served juncture Imunon. We trial As business to meticulously hires for we've top critical joins Quality, with needs pharmaceutical biotech fortify R&D in of operations performance Longobardi Senior President line for hired III crucial and decades this processes exceptional over as experience Operations. the of us with Biogen. Strategic of sectors. These

stays to sure study. We vital a in III on it planning and Kristin conduct track of Phase role expect play making budget. the on the

with [ senior General Eylward, at acumen Susan Secretary, Senior addition, Susan depth our Science and ] hired team other brings of as In that a XX Corporate includes legal legal we roles. background Counsel and to a various Counsel

ensuring I'd Susan IMNN-XXX the in goals typically the like into, some Our role reducing legal products, include call Dave? cost industry. And year-to-date. Dave to the we an has quarter enter the while to Gaiero counsel, in in-house third important over our now our for extraordinary to soundness also of the financial for partnering review turn will agreement burden of example, play and and results biotech legal incurred any

David Gaiero

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

primarily XX, $X.X XXXX, expenses in cash our fund the driven of [ third strategically were third XXXX. continued and $X.X we September of $XX.X cash General quarter ] advance spend into million development With with by and to administrative third for continuing as XXXX $X quarter of quarter of equivalents. on the of quarter and in were As third the programs, million operations related trial. cash, third $X.X the PlaCCin Imunon The clinical million focus X OVATION managing in expenses had to with increased expect compared quarter XXXX our while the of the compared was and our XXXX. XXXX. capital resources to million our million increase for Research

or $X.X was XXXX. million compared as the third share million XXXX, per third for the $X.XX for loss net of quarter loss of a with $X.XX of quarter share net per Our or $X.X

months clinical first The primarily Turning first related trial. the OVATION ] of General expenses XXXX. nine were and $X.X for increased driven of the by PlaCCin for X nine briefly with million XXXX development compared to to $X.X first [ months spend of administrative results expenses was nine compared of financial for and XXXX. for XXXX months increase the million the Research expenses the in million nine The and million first of and driven expenses XXXX. months employee-related first fees. of G&A the $X.X decreased decreased were primarily was with months months decrease nine the XXXX with as in first compared for $X.X first XXXX nine the professional by of nine

$XX.X for million net was or $XX.X back review, million a XXXX net per nine Our for call first first per of months loss that XXXX. With the I'll nine to of the of financial with turn months share the or as compared Stacy. $X.XX $X.XX loss share

Stacy Lindborg

Dave. Thank you,

a as several patient and during at III to number align mentioned quarterly with the are accounting I trial of As our runway including cash last capital. of of access to QX, Phase XXXX. end into steps Financing necessary cash a pointed point, will taken XXXX. and targeting success. depend call, pace of critical company our out, At needs we conserve this associated on readout factors, is by QX available But we've extends for capital achieve the The recruitment. regulatory the with to Dave this junction, costs starting our and in

ovarian the a are and able in cancer. with We funds raise and facility our to for raise ATM look who would more investors see from of substantial IMNN-XXX value

we provide license are or partnership COVID-XX year, and this end on to the the seasonal nondilutive pursuing read Our actively funding. asset before trial for vaccine out track is of to acquisition

technology interesting may an this other colon the oncology as and to likely have to IMNN-XXX, have pursue underpins cancers. and TheraPlas areas should do These so. pancreatic to financial may such resources application indications remain we Our

the orphan in trial to advantages and tumor I therapeutic Before have power ovarian of product in our lower unmet and market begin multibillion-dollar following Alabama and cancer I in along insights you thoughts. treatment effective with on ovarian study the for lack top granted an has treatment results want CDMO. in the durable of first and newly Avastin Biosimilar cancer. diagnosed the magnitude cytokines therapy FDA meaningful microenvironment. allow dose of drug achieve and over of durable been in call have shows with protected funded want Foundation approaches thus produce U.S. questions, A well-tolerated that fast with first a of Phase give or our for hands order OVATION cancer. Ovarian track anticancer by Avastin Ovarian designation into patients medical that's cancer you ability represents allows to evaluating with us [ leave only IL-XX and of Avastin. to immunotherapy IMNN-XXX to second underway need, IMNN-XXX commercial favorable GMP to our in may remind clinically OVATION is other to with in IL-XX the which of providing by could external and We gene is open production We've at the plus to IMNN-XXX status technology. been capability X place laparoscopy. release in cancer. ovarian the established toxicity ]. pivotal the IL-XX, our dose-dependent internal We're cost levels immuno-based runway. will for II usher and line an your into the and in II of to the The such and has its I other we Huntsville, This manufacturing quality through XXXX, compared product largely Europe, Breakthrough second-look advanced combination Cancer QX bevacizumab will MRD track reported additional

proof-of-concept in be current data, attractive partners. we SARS-CoV-X ]. demonstrated offers with the And platform a on vaccines. city our platform to trials. these nearing immune And recall preclinical response while We robust PlaCCin IMNN-XXX multiple is in the Our attributes has potential believe advantages over wait completion technology [ will

Chairman, Before to has ask I'd questions. the he questions, Michael? call to if like our Executive opening Michael, any

Michael H. Tardugno

have questions, have just here. any do don't but I comment I a short

believe results that a short measure shareholders, very the laser-focused a In with Imunon a seen organization that on to is by yours its suggest on this of we've of the the any future company, streamline we standard delivering patients' that mission opportunity. that update. optimistic for remarkable will together meaningful thanks and impact I agree investment tenure at our can First, deliver Imunon of bright lives. all be and and significant have sharing

I'll it that, it return up back with So can operator open to for questions. who the

Operator

Our first David question Zacks. from comes Bautz from

David Bautz

III to the other cancer would to in are first patients looking guess there combination upcoming. about you're are be, your of that treatments to be going on is percentage the percentage ovarian that Phase What part in at to I with And are any the that inhibitors? study My second going of advanced match study? try kind question PARP And therapy? you question

Stacy Lindborg

you patients on with shared data II we the we Phase inhibitors, the about PARP as that very even this can reflect shows that And in to expect community. call trial we've on what think the similar general

So what we'll see the as practicing community Phase well in as III.

which been from thinking XX% And in patients includes design trial. inhibitors the can ensure we efficacy. that and the Phase mutation have balance XX% now, inhibitors treatment. worked about It differentiated discuss so our we this that in there will receiving about our that HR from a is BRCA trial terms we with well benefit plan go group component We of and that of high a for FDA are that as could very So Is a have carefully as had that into that plan bring to Women perspective. deficiency, saw in is PARP randomization, shown and PARP up design is to that is balance. think right we something but II,

we're treatments question the considering. to other part are second that there Your was

this this we'll and explicitly And We are feedback get going on our very with discuss their in again, our included we'll protocol. FDA, have to protocol.

David Bautz

to do ready this you there now? that of right as you a right kind are to huge with financing as you that so How be go? thinking capital finance financing? far a launch kind of about study, you're the have going now. As thoughts Is Are the to

Stacy Lindborg

patients is very That's and of up fully and with required And terms to the full cash fund investor-friendly we're And correctly fund get currently in this in our with launching do the to fundraising, take burdened impact to the the looking long-term you And of a runway the that's pace right. the heard trial, our We goal everything means includes to time. trial the and running good with study. we are want will strategy. and for investors fully that and this at aligned best trial with patients know enrolling.

Operator

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

Brian Kemp Dolliver

have I'm questions. two to going

in point First place? on BD you've steps? you where the you you've [ early at started IMNN-XXX very in had Are you a activities. Or ], CDAs their mentioned are still

Stacy Lindborg

Yes.

We're comments data it's really opportunities we're are as the working partnership but value in we in-depth for point I study around very some ordeal are to our that and that not people product this really regard, it awaiting do, make to ownership intent appropriate from the premature I offer and to want have the fill us you is we out. and to we pursuing would So professional a expect very the our we and with proof-of-concept reflects one on guess of ensuring bargain. that any do intend platform, feelers

Brian Kemp Dolliver

And to Is relates interim that going comments have second some readouts. the and you'll question be expecting previous the the you're case? that to Phase III trial still

Stacy Lindborg

we very effective, Yes. trial III having on likelihood expertise for company. data. a assuming where we with for it Phase allow the design a looking design, Part of thought, fatal subgroup an the early trial, based I thoughtful outside of we thoughtful We've a you allow is our for strong and which is maximize to lot success illness confidence that overall a III, allow to really also believe I'm of could a have that carefully registration designed is on submission the It's given data also to in very for have trial. reads a Phase think, early the

a have to of lot this. we thought given So

long design we're with the But these investors in for trial allow patients very really and that decisions we have that of sophisticated with be to interest much talking with. us well, components FDA. best input We align would interim very field positions talking it are know that and the very will but product this from the term, about also

Brian Kemp Dolliver

this $XX details, that million is estimate reliable the given at but pretty cost previously there -- point? obviously, the you're you've are to fair say And finalizing

Stacy Lindborg

continue really that done really and you to trial and bottom very thorough when the this other come estimates top -- to attractive fundable what we trials think very of magnitude a oncology We've to with imminently is back is compare Yes. a in world. number

in very we remain yes, estimates. So our confident

Operator

James Our Molloy from Alliance question Global next comes Partners. from

James Molloy

I points able getting to time like you're of enrollment you the wonder be meeting environment be partnership share coming of Phase meeting interest and could bad of from end cut out expectations that that a PlaCCin your sort asset with the if And II design what you we trial any IMNN-XXX? of sort that, to of Phase would some lines for? then equivocal to through looking in for of and us characterize imagine would expect then the be look as or with larger advance for well. FDA? thoughts for the or even perhaps the you interim be walk good, where I a potential last would either pharma that could you And hope III question

Stacy Lindborg

is common as the our expectations the to So of Phase for end OVATION data, II the key goals go meeting trial. our of industry, foundation the is to proposal which the plan And through X Phase is III of in for Phase we'll discuss really one III. course, of

we with we, that expect very endpoint with seeking of advice discussion and proposal into we've of constructive be earlier, through that endpoint a a come that the forward input. The ticked of of II really been are conversation the in will there's their chosen that thought really shared trial. a I do definitive As them. gone we've of our look survival. inclusion bit the similar remarks, to And kind to select little the prepared described But our of that's primary endpoint, out Phase them overall course, and to we lot criteria

related second I question, Your timing. to guess, was

everything next But year clarify by and the to you this is month, enrolled patient of the end first we mind. something the having else of between end intending by are Phase occurring So planning had QX that if have you in the pulled II in together and that of protocol we the are can year. in

of work yet these lot not activation advance come not last given a be very intentional our and And move very know trial we've study done to have that be get to out characterizing and of the quickly. that we've XXX of the for environment. was we The data successful ourselves of to allow partnership hands. a to been the So able discussions, that important, we that the in ahead will will do in

So it's environment. to for really furthering been a the be that people talk making premature conversations with the we with We've engaging would key most little us. or will think be fruitful introductions who about And view we to to well share your means investor-friendly are and to to discussions minded remain our TheraPlas as best forward. lead the on think as that these likely also to propel open about continue company

Operator

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

Stacy Lindborg

vaccine providing questions, your development guys. And progresses, cancer and excited look ovarian of options a and very the for your partner platform. for you we great And in months. this to with work keeping further we for you appraised today coming new ongoing we you Thank seek an forward reporting Thank women from opportunity remain our data clinical as in for our We in progress. day. treatment and our us the of interest studies and Imunon. about Have joining

Operator

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

You may now disconnect.

Imunon (IMNN) 7 Nov 242024 Q3 Earnings call transcript