ACXP - Earnings call transcript Q2 2024 | Acurx Pharmaceuticals, Inc.

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

Operator

Greetings. Welcome to the Acurx Pharmaceuticals Second Quarter 2024 Financial Results. [Operator Instructions] Please note that this conference is being recorded. At this time, I'll now turn the conference over to Rob Shawah, Chief Financial Officer. Rob, you may begin.

Robert Shawah

Rob. you, Thank welcome and call. Good to morning, our morning, and company issued is on acurxpharma.com. press quarter a results financial available at website providing release our highlights which This XXXX, we for second the

remarks. Dave me update back and of then XX, corporate After the Luci, Joining from outlook. his to is President CEO, Dave quarter give and some who provide I'll call XXXX, the turn over and for that, financials the a will highlights closing June today ended

reminder, call, are in results forward-looking made on and Thursday, today's filed with a quarterly and Securities including statements. number from statements. and risks report XX-Q, These to that forward-looking current estimates on involve certain risks these As Commission we be XXXX. making contained change Investors of the filings events and information on during consider we'll differ described our assumptions, Form August our other subject future forward-looking X, based projections materially actual uncertainties to a the and cause Exchange are in that statements about should those information, which may

any obligation You're update forward-looking statements any to on such reliance these cautioned Acurx future. disclaims statements place not and the any undue time at in to

information the accurate broadcast of This live conference call contains time-sensitive of date XXXX. that's this only as today, X, August

Dave. turn now Dave? over call I'll to the

David Luci

quarter for thanks to and results updates. and to XXXX second pleased we'll us recent everyone, to the very questions. be take morning, joining hear review Good Rob. of Then exciting Thanks, for also any financial some our

III with FDA end Phase our readiness was trials Phase shortly Agreement some for treatment approval. of application, FDA, the new completed second Phase on of II quarter plan drug international a Phase for development First, a we meeting the to reached clinical lead to key and for or nonclinical III trial was in of III activities with successful April, forward In program. some clinical C. the enter complete candidate, ibezapolstat, with I'll infection. summarize elements NDA, a on thereafter. clinical Agreement with also antibiotic difficile for cases, for reached our of key FDA move our filing confirming a marketing or

We've seen III Phase Canada. to trials guidance C. treatment clinical into infection. to for regulatory clinical we're to Union, advance Japan for ibezapolstat In activities and the continued international submit in United Kingdom, of trials parallel, European also preparing difficile requests initiate the

clinical of of Infectious an Also or of in difficile ibezapolstat Garey provided aspects April, Society randomized we Dr. II and with for compared of C. Kevin Professor and data the of double-blind and entitled the board Phase ESCMID University for he's a Garey European a investigator and oral the program, our Pharmacy presentation treatment scientific advisory infection. Houston microbiome Disease Chair, Microbiology the for and is of Congress. microbiology College vancomycin Phase member Dr. attended principal Scientific ibezapolstat trial Acurx. study II

being prepared microbiological included our are clinical acurxpharma.com. The journal for oral II Phase submission publication. a on The complete to data at scientific website and and analysis prominent presentation additional of results available

the results July, the efficacy Taryn Also with from infection, oral of II presented XXth Biennial Taryn's the were of II Eubank, clinical from difficile trials. in was the Society results difficile and Congress C. in trial Pharmacy, University presentation PharmD, infection Research and Phase C. Anaerobe Assistant patients at of College Phase CDI, Houston Professor, ibezapolstat of by ibezapolstat of Americas clinical entitled

important specifically patent of given development USPTO, for timely downstream and a July, recurrence the progress, Patent the States the in microbiome. XXXX, ibezapolstat, we treatment a expires gut Also provide our of advantage. in C. very health encompasses This the which of patent us granted competitive and difficile an and or Trademark June infection United using infection while new think late-stage improving Office, will

finally, late-breaking news today. some And

substance processes the the II we to and successful submitted or anticipate to referred final meeting specifications product our to meeting FDA our review according our fourth Manufacturing clinical CMC for Phase the request Controls clinical trials. confirmed and bring in requirements, readiness, drug III our Chemistry and Phase of III end for as with to which FDA, our Phase typically a packaging, regulatory and trial FDA for manufacturing to quarter. Following FDA up -- We and meeting

have transactions our or for So of -- with more territory clinical as one strategic momentum global preparation we or now ibezapolstat, in continue parallel III to trials. candidate, and further further commercialization ongoing we for potential seek development Phase

agreement will update and if with a a when our detailed provide reach we party. third transactions on We partnership

September. Also, international is symposium America be in the review ID we'll of Slovenia, Antimicrobial the at World II current annual rest Disease the we'll in presenting for global difficile conferences, is continue results of in in which Phase including year, presentations posters venue C. roll in this Philadelphia to or becomes of out scientific difficile Infectious will this either various in October, oral analyses available Resistance the meeting premier as the or Throughout some at in data the Week September C. Society which new both, Xth Bled, include results our losing. or research. And Conference cases, from scientific

potentially Fast threat classes has results clinical of bacteria, an a urgent that low -- of and series ibezapolstat of continuing infection. for also for caused difficile designation FDA categorized as have reported treatment C. recurrence Center Control difficile antibiotics to -- new also continually Disease for outperform Track infectious disease life-threatening C. treatment in a the of we calls As incidence by

the at to our approved, do of -- favorable which is cost burden C. to make to come. the if is difficile ibezapolstat, believe recurrence impact health believe we system, $X.X by a We care annually. Additionally, U.S. billion reducing yet best estimated

of CFO, highlights 'XX. now quarter results our guide second And financial the Shawah, Rob? the Rob back to our through to you of for

Robert Shawah

Dave. Thanks,

this ended the included company For press issued ended quarter the second XX, earlier totaling cash The $X.X million with to December XX, June million compared were quarter release $X.X morning. of XXXX. in as our

financing an of XXX,XXX approximately under shares program sold second ATM proceeds its additional the quarter, million. $X gross the During with company

for and XXXX. XXXX, $X.X increase months the during million consulting of fees million, expenses ended months XX, an X X by were $X.X $X.X Research offset ended $X.X June reduction June manufacturing-related for to due a of primarily million compared million. costs development was the The in XX, in the increase to quarter partially

months XXXX, ended a in million an XX, in offset million $X.X increase June million compared costs of X and manufacturing-related research XX, increase $X.X were $X.X months to due development $X.X XXXX, the by ended For the primarily fees. $X.X X to expenses million June decrease for million, consulting-related

to months costs. million $X.X administrative months for increase XX, and the in General X for due XXXX, a share-based an was increase million professional of in increase X the $X.X primarily million ended compared expenses increase June fees million to were $X.X and June XXXX, $X.X The XX, $X.X compensation-related million. ended noncash

compensation administrative $X.X the The to a June XXXX, million $X.X ] were and months months to and million. in increase general For an fees, million due $X compared XX, of was $X.X $X.X expenses ended million $X.X professional share-based for X costs increase XXXX, million increase million XX, primarily in X ended noncash [ increase increase legal June in the costs.

months all XXXX, June million loss to $X.X ended share million the shares for for the had XX, $X.X compared And to the $X.X ended of for a mentioned. X months XX,XXX,XXX or for $X.XX reported per previously of per or loss months $X.XX June June XXXX. share, loss of diluted The diluted X a share million outstanding $X.X net $X.XX as reasons $X.XX per of a ended share XX, a million net the XX, loss per XXXX. X company XXXX, or company The XX, compared or of June net net

that, turn Dave. With over call to I'll the

David Luci

I'll all you, joining and open for turn Rob, call you of questions. to to Thank over today. our thanks Rob, operator, call the now the for to Rob? us

Operator

Instructions] comes McCarthy today Maxim Jason [Operator line first Our of Group. from with the question

Jason Mccarthy

look on trial is to program? that the partnership seek to III any the its funding And itself? provided to the fund company plan size you scope? try also, look Or and/or will Have in capital Phase nondilutive some terms what advance of and information to for could grant like a that

David Luci

we Thank guidance ITT or population provided be up they to for XXX the two are the international set vancomycin. randomized oral required There in be Jason. III. -- ibezapolstat so to are Phase with Phase going trials on an you question, studies. They a either Yes, and as would one-to-one registration III piece, patients

structure the that's trials. So

offering only with What we're III extent the and the possible it's then say, to program need needed. as of whatever pay or is you we attempting to all Phase can nondilutively backfill raise equity much to an to with else for we money, as if do

we're finance partner, to attempting III out royalty South example, whole looking the considering the to conducted, kind may and for there a are case, if -- an were pay be a partnerships, whoever III Europe, us. territorial including of entire among that two couple to Phase So in, by America, we lock were need for we the get a number We're course, do. that if would the like Japan, we big also which Phase are of to deals at a enchilada, buys of and get may be that in

I if that money or -- We're to with anything the mention to grants raise don't of. couple also grants, competitive names. just of to planning are nondilutive those have if grants to file thinking do all you want And grants for maximize we're will. don't the me on financing. a position nondilutive our equity that But pardon ways government I quasi-government

a even recent some bit that's with an number [indiscernible] still with little may these there's stuff a creative looking but start of outstanding that specs that And have interest. going specs vintage, at looking a more are we're that to

stream start new to they're the So going. willing

Jason Mccarthy

do new we I looking that see to happen antibiotic just rental [ Are or that's space cover it, on we antibiotic they when that if Okay. company there's a presentations around space right generally, for bit that? the something paying you don't new Interim are also the know you UTIs. could you're active Therapeutics], little -- for it's have your a guys actually to getting or of [indiscernible] watching -- presenting attention because one but antibiotic a at for

David Luci

certainly, [indiscernible]. them. we I'd we'd but team with Interim if don't we've I be to open Therapeutics, think have, wide to reached to check have out our

Jason Mccarthy

Yes. No, an to is Acurx fine. getting just maybe in in of opportunity tangentially. was space -- I But terms in of just benefit the activity busy, saying that's for terms

two what the last the Just of both trials is combined with phases? you question, think cost do

David Luci

together piece. So two should be million the $XX a

think a of instead see prices should concurrently. that Phase III, consecutively the we they the And million. an about together, rise trials first at with dilution, $XX significant we released, theoretically, the our positive price when you position with second But much then from that's to money should data III. higher So advantageous raise and can and run the do then share could be Phase

us the approval reason Europe, of Canada. uniquely from U.K. the that's because regulatory commercial XX to And almost Japan we the available is with protection and in years similar point of FDA exclusivity have and

So an patent antibiotic to this for is, patent that out would work which we very And if not get also XXXX, a new antibiotic... have for us. to on unique, actually going unusual

Jason Mccarthy

patent That more missed time, so One again? it. covers I

it earlier. mentioned You

David Luci

the protection and gut infection in microbiome. Yes, of difficile the reinfection the of C. treatment reduction and

steam. at But up some Jason, steam. your first about you mentioned that something It's address to question. up of end picking true I'd are antibiotics antibias like picking the

C. seen for the the of the would worldwide. a more with which we've We ], the Conference result COVID of experience even World because [ benefit getting scientific push where substantial in we'll at the expect classes tremendous think pasture we at have need. be like Resistance antibiotics cases the And to of September pass new Microbial government Philly regulations So presenting, in of happened a market in to it's uptick what's difficile. a

with like Now I other that's do scientific the to we a Resistance that and think to conferences is way world, Bled, in being Antimicrobial got what to antimicrobial benefit a need has resistance throughout Conference we do that have topic. enunciated up need, satisfy find real the the at want anything a to marry to become political scientific pharma. tendencies not There's hot because big but to

a find turning So the I scientific need to pharmaceutical to the without to think needs companies. satisfy the government and Congress bone way

Operator

of Wainright. with from is line question Arce next Ed Our H.C. the

Wing Yip

I is This us. Yip for appreciate questions of asking questions. Thomas couple a

from So Phase the III in study regarding first us question U.S.

fourth in CMC review the mentioned You schedule FDA for quarter.

So quarter dosing? we Or the is the to ]? specially start fourth events? expect it on trial Would be first [ fourth should that quarter patient when

David Luci

me of today, that where aggressive. naive be I it From would we to are think be

CMC the with -- we'd the think I lucky being be in fourth quarter.

in next calibrate we'd I be kind at [indiscernible]. lucky would first earliest. of the think the to my of I start quarter year

right? before with mean, the these And guidance. want areas that international the kind territory. before international want want sure are in enroll, we enrolling talked keep we in of studies, see I we regulatory to about to least we European mind, make to -- at Agency we Medicine patients we've We start their get So meet, where

It all in submit CMC can Europe, to in it in or then we the we the that's year. the by we stuff do CMC done we probably we've review Medicines to European of package which then to So because submit FDA's already conclude regulatory European include submission. Agency position. hope the Agency needs once November can't started, a would this which with the we can complete December and And process until FDA is the FDA, Medicines

Wing Yip

you touched prepared remarks discussions. in Thank additional partnership the Got you then it color. the Right. it. And earlier regarding for on

what ideal wondering to consider be for partnership Acurx? of situation Just will form the

David Luci

Well is it to raise as as to -- enough so market funding III, possible. quickly ibezapolstat Phase roll our and on keep get through to into priority a

our top priority. that's So

that, means that The III milestones and replace co-development fits for probably be an preference, to the be a would remove program whoever agreement or an be, is could say, a agreement. behind clinical some We lead Now commercial Phase M&A a European license we're Japanese take our we -- and could be to typical most try is could of and and with that if talking royalty. clinical -- factual of license as acutely it funding a milestones would would altogether transaction. the upfront payment co-development degree position agreement, commercial and it them that the

a those is are but play also there, we're some from America deal companies South a now. a wonderful a place be be hot And quite would mean would smaller pool chunky. a because also royalty of getting right that I deal. thing

million nondilutive the a $XX financial on be that you could that the that royalty Group at million And closing. So Finance does. financing based for of or get up modeling $XX royalty the

to. whatever So back may be Board the royalty whether on XX%, it's agrees number that our end, the is percentage a XX%,

Wing Yip

agreement us start All and both to side And following priority right. perhaps piece- the part one Phase then a is III starting U.S. EMA? sites the Phase Where first the hand, III Would and on that ex-U.S. sites, possible from with what in of of last possible with as is such Phase possibility -- U.S. the kind U.S. in stock on thoughts start question to be the your to out roll up III study?

David Luci

we gotten from make we that not stopped talk to by to had of if don't R&D we're stepping any do that our it make or not some Europe to to we on could toe if were team I in to we we're be Yes. we mean Europe that, that that kind sure have to sure have doing in want pre-agreed. -- --

certainly is something in. that we're interested that So

Phase the today, still the X I'd piecemeal we'd If start, had financing of in do the least IIIs to target X be to say on quarter. fourth at we

Operator

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

James Molloy

you walk want up a have my Or changed I about have more how acquisitions. speaking perhaps do or people about on more this environment outright how It for faulty relative be in the be size sort to quarter? the or little But than been little Can purchase the number over Jason's challenging you call, like last sounds maybe you talking to? you levels biotech company partnerships. through of see I of may you're you a may a so. of to may follow disclose it's memory, little talking to bit question looking? things a or that on over you're are able the know year what space

David Luci

Yes.

So substantially they are. to, they're that all size, talking the than range but companies we're larger in we

medicine our if some of that all And names we recognize we'd are them household open cabinet.

it's you anything, So didn't range and great miss James. a

appropriate we earnest formally time end of process were of we around last stuff in stuff about. process that all middle FDA I we the the and good time, We the the done meeting on earnings -- to that starting in announced of started had at May, that call. derisked because in the having call with pieces this And point what consider II really having our Phase talk some our

they've So -- parties name And country. interested audience of and in the think, I we've dozens M&A our business bio hired up out May, on and an had, meetings and got that the CEO behalf. to household Diego, around works San with XX I side. And timing more late was reached -- conference out unbelievable I in because signed on and potential a a the consultant

have more of agreements We confidentiality north it's number XX, a a lot less than I but anticipated. than maybe signed, X,

closing grenades, and hand and accounts Now horseshoes right, James.

to been until done reasons the have about are that. more in I But we close So there And for it I it's as the scientific talking be is than not a Jason, with of interest interest, something space. out and lot anticipated it's and done. antibiotic think would there's

You and an responsibility think along because see of [ these publicly problem more antimicrobial and they're the about of resistance. saying more things Listeria antibiotics And and new classes diff ] I C. regulatory also other peaking. need the social WHO, there's about CDC, body, the of with element of some for

Arce, that base open an to to to way of as potential looking We we'd as as market. like prompted not I But book. would do. dilutively in to we're ibezapolstat we're So I answers your that then do can. a leading partners possible kind out get what And as Ed -- like to with we And listen know so discussions we're as if question. don't for to these mentioned keep to

worldwide folks some rights. like So the

They in that positioned way. not are have folks infrastructure, don't the Some say, U.S.

would they more European of deal. be a or Japanese So a territorial

go seems hand hand America South in to Central America. with

biggest to the there. So second we're and talking down biggest

what can't going agreements. on. that confidentiality violating So be -- mean the without we have I that's don't I more transparent I know on

James Molloy

ATM it I accruals, -- two up as a recall. $X rate Shawah million the as always about always, ATM, note, current as not the different even then, as kind with have $XX What's have guys can, negated -- the I'm interested with the as following you the almost nondilutive methods? you counts appreciate the get very for you're say funding cash before does with the that. Rob million question to what also I total. you've you of run in absolutely used on ATM, you But utilizing with to No, you partners in closest know or or the but And these potential on on much in that I much.

Robert Shawah

yes. ahead, -- Dave. Sure Go

David Luci

the I say, to Well, of Without middle ATM, the any we ATM, sufficient on like without until middle of 'XX. the just trials have 'XX. going with was funds it's probably the going probably

Operator

The the Jonathan next is with question [ BioPub from ]. Colmar line of

Unknown Analyst

ATM Kind many are still on question. outstanding shares of the up How following that? on

already financing? secondly, previous are then And -- from still outstanding there

David Luci

-- set much granted ATM can many there's any associated sold. way there's what are we up, it. just is price is the an is ATM at the cash just intraday Yes, the off And how of math Sure. how We no the -- shares price and given share an of day. with share down on pull number

number like isn't limited. So where fixed a there we're

-- question I'm next question? what your was second sorry, And your

Unknown Analyst

previous outstanding from still financings? there any Are warrants

David Luci

Is number? $X.X warrant million? the about what's it Rob, Yes.

Robert Shawah

$X.XX. actual outstanding There financings million warrants. exercise and warrants is by $X.X warrants The from Yes. outstanding average million. $X.X are from weighted legacy previous number

Unknown Analyst

pulse fangle an like what kind bit could, through new Kind you you of David, will. at if an a -- does how microbiome of of So you new give that advantage? it's a you walk if thing, you said, patents? could the kind of this

David Luci

the advantage U.S., June we that out in we Well, patent abroad protection goes first that XXXX. is can which now have the export to

the of just a slow years that's value can It's period enrollment of a before So this is for thing. kind time. commercial really of we lot any -- on question long have

the in in healthy from fact What's we of the the antibiotics reinfection, is microbiome. that's That's unusual U.S. gut to an imbalance that reduce bacteria difficile have validation and also, kill dysbiosis. able about bacteria. likelihood it PTO ibezapolstat restoring the the we're of is healthy patent And able part and cause C. most now to is

causes. dysbiosis say, in not who's anybody So a microbiome. help antibiotics fact, healthy as to need maybe being just replace antibiotic the that look and stuff good with because will dysbiosis we find to and cause at don't restore generally, other because don't it we at Maybe looking antibiotics a cause our antibiotics well, of thing need they dysbiosis

in regard, its the of that antibiotic So that kind know it's of. only I

Unknown Analyst

clinical Got specificity the seen ibezapolstat. Kind already data in preclinical what you. kind the very of -- and of the well we've of of as protective codifying as nature

David Luci

to think business you pharma development reputations just helps And big when want make to to pharma, science, be they tied to big our And their within cutting-edge companies cutting-edge to and science. and tend want Yes. this case. about these tend -- be

Operator

for Thank joining like thank you. time, everyone additional At to are our today. conference this questions. on no us there I'd

at You lines thank time, participation. disconnect your we your . you and may now for this

David Luci

you, Rob. Thank

Robert Shawah

Thank you.

Acurx Pharmaceuticals (ACXP) 9 Aug 242024 Q2 Earnings call transcript