ACXP - Earnings call 3 2023 | Acurx Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and chairman, good morning, and welcome to the Acurx Pharmaceuticals Third Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawah, Chief Financial Officer. Please go ahead.

Robert Shawah

Thank you, Ryan. to welcome and morning, our call. Good me we and company morning which available at issued our as the and Luci, quarter who DeLuccia, the our programs, give including manager a II and results will financial is will clinical acurxpharma.com.Joining who website Acurx corporate our update of Chairman, of providing release outlook, on provide Phase trial. is highlights CEO XXXX, David President press of and This today a Bob Executive his for perspective third development the comments, be After closing back his financials XXXX, certain making over ended provide and Dave's the XX, we'll for Dave remarks.As I'll forward-looking the statements. a some highlights September call to for reminder, of then during the turn call, quarter today's statements statements.Investors our our including uncertainties information involve actual filings Monday, XXXX. change contained may to in and the based filed assumptions, are events in information Form which Commission, with and forward-looking and Exchange we results future differ should are from other current risks estimates and forward-looking XX, XX-Q, that and that of on those about yesterday, Securities report projections materially made described subject to cause a number on quarterly November risks these consider These

circumstances call.I'll Dave? to the date time to that's at date information time time-sensitive Luci. any in live You over as to these events forward-looking forward-looking This no to reliance revise such the statements obligation call today, obligation Dave or and only XXXX.Acurx or not any undue contains of are statements XX, conference cautioned statements any call of now undertakes this on the place update and this update reflect Acurx of to disclaims accurate conference the turn broadcast November after future.

David Luci

We on to later was of these thereafter, disclosed appropriately options long-term trial the the treat which the will we representation of presenting take for excited trial provide everyone, ibezapolstat, for we'd assessment.The the in some oral in in for these any believe results difficile the based extended trial, meeting has that rate November vancomycin. efficacy the thanks clinical on and X, ibezapolstat Phase cure to well clinical established available clinical each the data, evidence comparative also most decision of IIb an care the determined The comparable for II updates. antibiotic to line impact infection trial, independent with be clinical endpoints clinical Thanks, exciting XX third EOT that patient's a in and recent provided arm be XX the and the for non-inferiority and rate from secondary antibiotic include address shortly C. curate or it XX, exceptional XXX% committee clinical by primary we weighed trial the now need for ibezapolstat, from with be review sectors concerns IIb impact Phase with September Phase up analysis clinical in an clinical III IIb as to both these and clinical in the clinically advisors, cure trials. data diff Phase Phase IDMC about trial.Based amended clinical over days. determined available the and days, been when private of review sustained forward to that Phase Philadelphia data monitoring the of IDMC. trial early on or the for ibezapolstat field either the the The statistical open-label as were consultation our antimicrobial safety the No reported or the a quarter vancomycin all C. need scientific some XX endpoint non-inferiority on of to in at XX. be Congress Ibezapolstat EOT to Then World key convened cases observations will will originally treating ibezapolstat include diff IIb the in activity CDI. dual cure of between experts XXXX, our including all of anticipate our Further exploratory The will including managing exploratory quarter is cure, company the move appropriate is to blinded Resistance efficacy clear the in clinical patients II data morning, Rob. of in third of or out ended end our the and XXXX, we experts secondary while X end particularly XXX% the microbiome, X, is us of cover to Phase we the the lead latest microbiome.We XXXX for in XX for IIb top therapy.For consultation review pleased IIb Good the analysis, of the IIa from innovations and following. of the enrollment joining Phase treatment endpoints XX clinical interim endpoints in separation infection. questions.On Phase on when of treatment and obviated cure clear acute October with and C. patients, reported XX trial for an Anti-Microbial in at financial public next and XX%, to and highlights its XX remain designed for Phase interim annual XX% in to the its or including On therapeutic resistance. infection where XX with candidate

October presented the X Inhibitors website Boston, in presentation ].At Chairman to Pol events. entitled, which acurxpharma.com others for XX Bob the Novel Executive Gram-Positive Acurx for Infections, This us as was scheduled describe an on XX, with Our Bacterial at acurxpharmaceuticals.com well available Preparing Week (sic) as DNA that Pandemic. XC is update I'll our DeLuccia, today, ID convened [ Next featured

provided of program Activity trial Dr. and oral of for entitled, Garey, and the by of of Elucidating Kevin Ibezapolstat; the the College chair, ibezapolstat was trial. microbiome investigator Analysis Selective Secondary Pharmacy, our Spectrum Gram-Positive professor principal IIa Houston from Phase First, presentation an University aspects

ID posters on Molecular to was at information Infections.Next September Acurx conference International Canada scientific Acurx supporting Pathogenesis XXrd. At presented during the Novel which pharmacologic at symposium ibezapolstat's XXth the was the We Banff, there DNA entitled Pol meeting, up entitled provided Bacterial presentation Antimicrobials Pipeline. X Conference profile. from unique Biology the Week inhibitors the of Clostridia, Gram-Positive and were in presented new symposium New at the in Secondly, XC ClostPath for

of Clostridioides diff virulence production difficile vitro bacteria. in entitled showed modulates was ibezapolstat reduces The ibezapolstat factors the toxin X first by C.

ibezapolstat The C. Ibezapolstat embedded C. difficile. was second Vitro and Antibiotics used antibiotics, as Comparator of effective currently C. Studies the as fidaxomicin, vancomycin reducing diff In difficile showed anti entitled and biofilm Biofilm metronidazole,

results in third Rob? diff the of unfavorable entitled metronidazole, Ibezapolstat vancomycin our caused Other our Anti-C. available Agents proportional increases to website.And highlights on increases presentations but again the of to are proteobacteria. through to proportional All the distinct financial favorable Compared showed third fidaxomicin which from Metagenomic XXXX. of and our The Evaluation CFO, both you caused Shawah, now for guide and ibezapolstat quarter in Rob bacteroidetes, back

Robert Shawah

Thanks, Dave.

$X.X cash this quarter third compared million XXXX, issued the subsequent for costs. trial development for December ended results expenses did morning. were third The XX, also in company the in October September the IIb $X.X of for quarter X $X.X I'll million September related XXXX.Research months XX, we for cash receive XXXX. $X.X as compared and to ended of totaling X due conversions XXth, to timing to September press quarter to ended XXXX Our the decrease The included XXXX. XX, XX, note million was the warrant million were the financial months the million ended earlier in Phase that of September our release to $X.X

to due million were $X.X in $X.X XXXX, XX, million September fees. versus million trial months the and million Phase to costs the XX, XX, and compared $X.X ended decrease months research $X.X due X September an million consulting and General is were primarily X ended increase months decrease months IIb administrative increase X ended related expenses to the for XXXX. September development the professional ended XX, The in for The costs. primarily for expenses For $X was XXXX. a XXXX, September X

$X.X company of diluted $X.XX X $X.XX a ended reported compared ended and of net or net in per of of a $X.X share to share loss or $X.X diluted XXXX, months or versus loss the XX, XX, X per the for ended for September months million XXXX.The the XX, million X share for million XXXX, XXXX, net September million September X a net X per $X.X ended for the months ended months XXXX, shares $X.X September million share For outstanding as loss fees months for in back increase of had $X.X call to that, mentioned. of offset $X.XX the September the XX, reasons months a ended I'll Dave. a $X.X turn million professional XX, compared XX, $X.X diluted all XX,XXX,XXX September to XXXX, million, the $X.XX the September X for general The over decrease administrative company by Dave? previously an expenses of reflect per compensation. were XX, share-based or The and amounts million XXXX.With loss

David Luci

and that during us in of coming build to even months. growth times today. areas on to will strong We Rob. advances in future sharing momentum joining Thanks, challenging And updates we fundamentals. to you look these all momentum continued this believe sustaining We forward and spur the outlined our several

Executive completed our and manages including given of the advance in programs, to II trial. Chairman, clinical Phase our provide Now Q&A, DeLuccia, I'll perspective and recently my ask Bob? development Bob Co-Founder customary his research Bob

Robert DeLuccia

exclusivity regulatory think we European is new market midyear FDA. as our for line Medicines for United years is, we'll a It mechanism in antimicrobial evidence recent milestone, support in targets. your next an clinical have class time, Bottom and to the the of XX expect their age year. which III trials my have a specifics patients stakeholders a trials Agency clinical I important of It's The and updating for used and first our advance commercialization have clinical in Phase by the with same States, bactericidal trial patented. important well.It to of and this conducting new of end strong has of works outside antibiotic fully Phase U.S. introduction action. is step submit to we meeting post Phase a enrollment guidance to outcome the FDA around antibiotics.So antibiotic, to III fast-tracked clinically extremely and the XX our to infection. promising Dave, closer data for well. design further with recurrence we've which reach currently a what care It's the II on resistance this and readiness comparable potentially standard and Thanks, demonstrate in a from treatment. on need continuing this can the expect emerging antibiotic the infection robust days we also takes patient well-tolerated present old for of plans microbiome demands of to all to life-threatening serious ibezapolstat manufacture, on to confirm this From after to new X efficient cost-competitive perspective, be the effects novel so that development very thanks to to so in we And marketplace. far, less At and It's favorable seen especially meeting. our package in thanks CDI now the will progress, scientific treatment we

be next infection, States.In gives up a diff And in antibiotic vision at Dave. outside to experience we'll and approval with a microbiome. to our health In the only and, better of and me in success, kills beginning preserves United forward C. be in you, here, the that my rearview public bug mirror my a over market got the patients general, and next we'll pathway winner development Now and but introduction shareholders. I've ibezapolstat for for for countries not for clear opinion, simply the course, a back diff and deliver C. since years' XX U.S. marketing, assuming that think III only Phase good I year, the antibiotic put,

David Luci

Thank you, the call Bob. I'll for questions. now Operator? open

Operator

[Operator Jason from Instructions] Our McCarthy first question Maxim Group. with is

Michael Okunewitch

off, This is I'd the first Michael Okunewitch Jason. congratulate like progress. you on on the line to And for

what Phase III ahead costs? endpoint. bit us a thoughts terms me also that? on as in size program So scope, could end still an I meeting be more in to start you of off, guess just look II your to of like thinking you of for you're then if potential of like Can And what of a to give you the Phase targeting would a idea of I'd give and non-inferiority primary terms

David Luci

arm, in at vancomycin, targeting Phase the considering looking still get diff. in trials. which much treat we an the to X in first Summit to have would antibiotic Sure. most more did What an oral this control clinical in which And looking C. like considering, is patients noninferiority its that registration to you hope recently be we're Phase would fewer approved preliminary, we're second smaller in effort for to case yes, we're continued registration our as raise see at III, to this first and potentially is with of but we and could And And raise we pursuant to trials we're would so possible imbalanced the trial trial mind X this because in patients the have approach good that all know, exclusivity we be with uptick an to we the trial. uptick entity hand, a data share XX trial. years trial, in fund status in us would money money III noninferiority for our molecular approach QIDP. for price and use Keeping of very market new sequential second is and that

that's think do. I what So we would

we look XX first think I we it gets something on preliminarily. the patients and would X:X might FDA, a XXX randomization would and oral I our try like to have team ballpark potentially and the on figures, through think If vancomycin. ibezapolstat science trial that

So people it be a much a lot think thinking. that trial more discrete of would are I

challenging. company pay a to small that won't, for be So won't it for

Michael Okunewitch

one then I'll and in me, more And hop for queue. right. the All

talk ]? secondary of for threshold we're as Banco you're to those getting analysis, little looking to points? we bit of a reach about What end up terms do those you Just clinically relevant could in what in from secondary need specifically kind [ separation

David Luci

that thing advantage think is do. the most that's antibiotics the that we key the advantage So microbiome don't because

which microbiome the mechanism the of how the baseline, action antibiotic know can that's infection, we any do other time, that's We're while I restoring healthy studying if to that. address acute something fully at So still same a to able of don't also to to only see and itself. XX We're are antibiotics days done. that reinfections diff folks out that far clear there that have provides think formally out. least, I that no the by gone But for see that's separation C. at

subset patients XX-day out out excited to are data in vancomycin. of many reinfections patients ours to particularly I'm how that see days a compared So about of XX

material And So we nonpublic those SEC and period for of we're sort what of perspective, pieces. a are X and since corporate exploratory to to real all going of any for don't secondary purpose. do exciting time material be the from endpoints the are want holding level so information

won't together, the cure, as out it clinical be We it. getting out we'll it and comes the be data microbiome comparison. the it the clinical we we'll extended sustained get as So of course in, wait receive cure all for to and

Operator

next Our Wainwright. is Ed with H.C. from Arce question

Wing Yip

Ed. questions for This is Yip asking Thomas

I data? question, be When this touched to companies? purification medical expect Will -- will little see around II we can in more believe first or bit. you a a Phase major So this perhaps be on it

David Luci

information? I'm secondary see sorry, when can to the you expect endpoint

Wing Yip

Yes, that's This II analysis. additional right. Phase data additional

David Luci

see. I

Okay.

have disclosure. we'll terms then disclosure, the -- to start conference out a first press the in for turn press DeLuccia So -- it scientific Bob I'll release over I'll with and

come in up we'll the out air. data. the on with sustained extended still And press the of December. FDA, or the very clinical December around bit the data, think with press in have on data? January, have a release the March, first you we'll is we'll press clinical microbiome. the have to I the release either scientific or out course, after January IIb a some XX-day Bob, cure meeting data of the in on releases, Then, we'll and that that with likely the But But mention cure in the completed. in have it's too we'll February, want did Phase presentations

Robert DeLuccia

Yes.

I for becomes the well. as But final year be Dave data in it we'll get of we as think available, the data publication said. as concurrently, with we report, preparing study next as targeted early some the

Wing Yip

Great. look one us. that. just We forward question definitely one more to is financial. This Perhaps from

Phase sequential what be thoughts, a conducted study? mentioned forward Phase You earlier estimates in provide costs manner. first initial on III study? little are III some estimated some And a Phase Can this for expected preliminary to III you options move to is this

David Luci

will weeks. trials, know, of I again, between million. $XX first we to the is of in We plan going think coming data. and million mean detailed preliminary. $XX the And our as Yes. have you X But trials X -- depends and this on it probably the the the first we're range unveil

of right successful million, exercises, have in, and between of that, a here $X more in now, shares. we can another which have what I with about to terms announced, But $XX as possible. lift as to for tell as detailed we So after And cash going don't we it's you the some plan. million we have heavy is humanly warrant we data a expect sit coming and and nondilutive very beyond in warrant million $X.X is see that be

Operator

is question next of the Partners. Alliance James with line Global Our Molloy from

James Molloy

with reinfection III? to you Phase dosing, through through little that 'XX, rate what did in did in little ties with and obviously what where hoping but their your us to are difficile ibezapolstat Could on Can into sort guys of maybe analysis how and Summit [indiscernible] Merck you and bit, right what a approval. wrong Cubist the the failure the little competitive Summit you here a walk diffic bit walk do a

David Luci

to because open-label out they in example of -- an cures III is Sure. The Merck Optimer clear Merck's went XX XX trial. example with most Phase the predecessor

another XX in IIb XX IIa. have XX and of We of XX in

of going at So XX. XX we're

mentioned, is robust it's data. Bob by as package manufacturing, preclinical our and other a So supplemented and

look. pathway. COVID So well what a model we wrong, expect we're done our which superiority a are primary and as so from their and superiority we're public III, But Therapeutics, to you changed well. pathway they they trial. that gather sites the delighted they had a and that wasn't quite while What trial to international the they that internationally. data the took did try clinicaltrial.gov. that, go others and endpoint FDA that. of try the through ratify you Summit can to successful trial, actually the a at the on fidaxomicin I I And for And after kind it, sites enrolled get FDA have Phase trial, And with following be -- wasn't involved. see they understand like they with only we Jim, their from to XXX FDA disclosure, it did, unblinded But what they comfortable conducted as conducting with And they around to and mentioned,

how And was And quickly. we our to IIb So good FDA also don't Advisory do this I of that we make sure was know was. very trial to and didn't that data happened. Phase unanimous Board of that. exactly it us decisions the were make reached prior Scientific We at ending agreement think right they We and to we decision. kind that getting back that monitoring are to the out in series copacetic our committee certainly, the everything and contacted contacted independent sure

how like ran of that's an of kind Summit kind III. to So Phase alternative their

is we their III that Phase So of the about enrollment. the pace thing like Summit's

time. I X think about years' they internationally patients in got XXX about

Our the neighborhood XXX-ish. I somewhere first of study will in think, be,

James Molloy

the help as microbiome just and and vis-a-vis them talked How recent a very do I the about -- think not look about of talking some didn't They quantify what, on were their plays to FDA's the And Understood. Banco? you relevant really much. do into company data how sort ibezapolstat, also, are you you the they being one to microbiome? most decision of again, the pile And much of with obviously at. noninferior know well, microbiome to healthy healthy -- that

David Luci

so microbiome, I imbalanced and important And think just as all diff, it business microbiome. things C. are sector, disease, you kind generally by the outside of cancer more diabetes, have it's reason C. or is it's why because a kinds to an when an we of more of leads imbalanced find it's diff triggered fast-growing whether the burgeoning or microbiome.

in best right? the Now cause And U.S. an in $X.X primary the market C. C. reinfections terms billion is diff microbiome, a the diff, of of reinfection estimate is year imbalanced

nice the if dent So you in microbiome, basically health you're market. in able healthy to restore public the C. a very can Diff recurrent make cost a

an microbiome a a vanc, oral we broad it's role. from us to that's has broad because going So And spectrum the important just play which think to going -- it's spectrum. antibiotic it distinguish decimates like

XXXX diff. that I was such that to tool so answers vanc was approved the it's got it was that was in need XXXX. useful its because out spectrum, because there a in but narrow first not that C. think oral to It best I just diff there treat hope wasn't treat your spectrum, little there broad question. it was was approval approval and C. the

James Molloy

couple It a could, questions, on PASTEUR And updates I just the please. if does Act? indeed. Any of

David Luci

more haven't what's And sure government we're is nobody had up They're being coming going thinking different of idea shutdown. watch of understand I government keep I any Act the looks legislative are open updates there's no We right on. But the a I I there PASTEUR have like specifically. now. that to out realize number it ahead to more trying the mean, holidays. the the that Washington, options considered. We I'm on another

James Molloy

vendor are a please? here Robert. XX% last on Keeping what the in a quarter. expenses third close [indiscernible] on question for eye walk of Can you that, the accrued us just the the through Maybe Okay.

David Luci

want Rob, do to? you

Robert Shawah

our Yes. organization. that's research clinical Yes,

Robert DeLuccia

yes. CRO, Our

Operator

from ] question of line Stinton Our [ next the John Investor. is at

Unknown Attendee

is it fully superiority that, to noninferiority? will when possible rather that prove XX-day than regard with digested study the So study, clinical

David Luci

driven. numbers be will interpret, There people be that can won't it statistically but

Robert DeLuccia

Correct.

Dave. right, You're

Unknown Attendee

clinically your indeed you that all? did was And were expectation to it measuring follow-up that is was the b would Phase you non-inferiority, said it original not that superior? time a at were not? disappointment prove was it and prove Then just Or something IIa that studies, the Okay. at

David Luci

to measure monitoring mechanism, statistical test bed the mechanisms put committee of Well, those that noninferiority, for with to was the for superiority. But just independent got if kind and so data there when evaluable trial originally, proven, like plan, because few non-inferiority in to are early IIb mathematical Phase to patients the we There the end for to was IIb. superiority. no measure or decided mechanism

in in to III Phase registration So II, comparability trials, you need clinical move to Phase establish unlike on to III. Phase

decided many and So or that would there are how to be move positive, Phase at certain was looking establish and clinical we we comparability so on looks III. it since blinded that able were the could in there us you to were, case, that data we to failures not, see it our

want table the didn't a on our we We -- we a market have number as figured move the let's possible. of and want as time, to to off waste soon win money we didn't it drug table the So here, for the reasons, and not have take at on.

Unknown Attendee

Okay. October pretty on traded in that? since is had you unusual. with million days any day, exceeding as of One in a question swings almost -- which wild price this XX [indiscernible] shares some the single comments X X, and we've some as million last many very have being Do is

David Luci

the kind quarter. next time So coming at right? first period more data, X of with of end out releases came we in of the to mean, out even data. going to with the be solid X I we're ending press No.

the more of of a day, have you first expect the about At quarter. days now end to XX,XXX trading daily we this the maturation So is of were note average end high-volume lot a and happens. will corporate what trading recall, part shares I between if XXXX, as that volume. we the process,

of and So now rearview as pharmaceutical Bob it's sense, trend -- you ready I And institutional and it seems company. says, will entering our become the that well, coming me the the to Phase hands, and that the It mid-life more we're it microcap of I as we III that's about company. at kind of this like public to through it is me, and entering very in our every say healthy will of notion expect look in like which What are more the now continue. seems out to filings I ownership. as what we mirror, as for more more shares another thing be

Operator

the Mulholland ] [ Our with LLC XX-XX [ is next ]. Ryan question from line of

Unknown Analyst

of Was questions. One that a to block IIb X assume you randomization. arm? randomization And Phase were trial from vancomycin regarding go it. that are And can second the that then the participants Just couple then for the and -- question a the used? we was incomplete

David Luci

at arm randomization. randomization the IIb opposed the going just a assume don't was protocol centralized I tell don't as I which Yes, the local I X I know in. wouldn't in to What is, was to don't done and level -- know say, I that know a what block they violators, were randomization the can I is you

not sure think block X out. it's where come I the vials protocol I'm randomization. means have So a entirely But that not

Unknown Analyst

information know will you that if Do Okay. be forthcoming?

David Luci

to expect because they're I mean, haven't don't know. I protocol violators. asked I

if that So that had I information. I assume there's nothing can

I think even don't asked I So [indiscernible].

Unknown Analyst

then taking where your year radar? that's discussions, something participation finding M&A that that past had own? have several on And over to have investigate partner. who on parties your and there you've kind you interest are to the maybe yourself, a interest of several interviews signed Phase but still interesting lastly, Is potential their NDAs III And ibezapolstat in discussed not over

David Luci

Yes.

risk definitely III pharma do M&A yes, off is have sharing And our with for signed in lot confidential, some a commercial is in to cases, we Phase the names. NDAs for parties. the think They on a partner there. So But there's calendar with prudent period We idea. I XXXX. being interested bite yes, can't a you big tell

not X is exploratory deal recently or to out Now And we deal. the what from endpoints our a will takes a are completed fruition. won't parties whether unveil secondary not know value what certain trial. find and come to it the create we I'm until and

the that with launch asterisk were start of that kind then ballpark if within they to move I'm But Directors to we of that's it. if about get year, have that committee we the interesting, sheet formally we'll than have were formally forced be us term process. and in a process would earlier first special -- information they may quarter meantime, sure that forward a find then we So have an order in the we expected. the form But the Board in to generally the of

the the idea And C. what I of refer to can like. now, evaluations for kind get you you So recent in been deals consummated. of space have most would are just diff that an

that So was sold $XXX rights one deal Tillotts look end big, the only Pharmaceuticals, deal million, $XXX in until that Pharma I which deal the million isn't upfront when November be XX to the of million Astellas Sebela years very don't know, all which, was Pharma might was but Destiny payable marketing of money of $X and another out. from or European XX fidaxomicin, AG And the period, Europe. to with XXXX

how working track of see something shows M&A are look And with in And data. the to see separation we clear get a hopefully done in we'll III and in able data So parallel each. Phase terms the and we'll that preparation, our space. And those we'll comparables be get on at a we with XXXX. our we're far

Operator

for are there conference comments. the closing hand his to David questions, now As no over would I further Luci

David Luci

conference the questions soon. of look We're your coming you much, we updating you for today to Ryan. forward to and pleased expressing and thoughts Thank and all you very

to buckle be great tight and sit and up year, is a Thank we Let's expect. going you. XXXX

Operator

conference you The of has participation. now for Acurx Thank you. Thank concluded. Pharmaceuticals your

lines. your disconnect now may You

Acurx Pharmaceuticals (ACXP) 14 Nov 232023 Q3 Earnings call transcript