ACXP - Earnings call transcript Q1 2022 | Acurx Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Acurx Pharmaceuticals, Inc.

First Quarter 2022 Results and Business Update. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, the conference is being recorded. I would now like to turn the conference over to your host, Rob Shawah, Chief Financial Officer. ahead. go Please

Rob Shawah

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

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

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

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

David Luci

conference Thank to our you, review results. call this joining and on Good for Rob. financial thanks us everyone morning,

double-blind to leading were take Phase first difficile for enrolled Xb then Xb CDI. treatment the oral a of ended some trial trial the C. treatment ibezapolstat, oral any of the in patients X-to-X, Xb results this Infection our During more vancomycin, patient of of the call day at pleased patients endpoint compared measured Phase clinical clinical we’ll first The trial the double-blind C. XX trial highlights of difficile a we'd key and or cure CDI. a standard and non-inferiority, Phase clinical trial, corporate the to of primary the antibiotic XX In to is be March known our for trial. day care cover endpoint until end the candidate The is ibezapolstat, secondary a treat quarter, results XX is Infection be randomized clinical review of end sustained as will quarter cure visits. today's follow-up financial at and also not questions. Since with on XX of measured

in conducted the expected operationally the the and these protocol Difficulty] in the today. will impact trial, comparing Phase the ibezapolstat However, trial is ibezapolstat reported for to event is proceeding and vancomycin. vancomycin an of signals [Technical endpoint included as superiority. demonstrated between non-inferiority test In analysis on exploratory microbiome the be further Xb Also

as day and C. with on than following. we've treatment our on day second XX include on Xa long-term for to been advanced currently this Xb XXX% enough end in the ibezapolstat this pol be XX exploratory resource well ECC effect such highlights the Other with patients follow endpoint at Phase added trial late in treat related first with for of we for will or exceptional expected include reported year. have at other therapy. impact the demonstrated of dual our clinical based treat infection matters, evaluate gram-positive inhibitor, believe infection novel We of more up and disease about treatment is which of of acute XXXX, cash clinical each infections, for to to after in Additionally, or while to particularly conducted as IIIC XX the of XX reiterate trial difficile the that and the enrollment completed a visits closing of date. has treatment cure with a clinical which longer-term U.S. our the Phase our patient's of R&D appropriately XXXX as the IPO To a CDI, trial day excited to in stage recurrence. recurrence development strength remain sites The study ACX-XXXC, data currently to Phase other of DNA results, MRSA. comparable extended ibezapolstat Infection after to half the managing Xb selected in group of including key the no the no of of the XX-day lead eight Xb development cure June bacterial reported the allocate Phase preclinical quarter for of previously the knowledge, from subjects the using we long-term optimization visit, used microbiome, We ibezapolstat’s of complete to antibiotics antibiotic microbiome of the second CDI care

pipeline ACX-XXXC a to and inhibitors regard been The in and we mechanism-of-action Leiden research validated Phase final Institute Disease is and resistant multi-drug of will more data the this mimics an to National year. the the grant outcome million and new continue Center approximately in external Allergy first and are initiated of to The Houston program of and antibiotics We're a polymerases trials vitro expected project microbiome the approved, company The comparing for decision interaction intended with one end potential way in costs. other bacteria, is of Shortly our Medical and against NIH, including using funding pol that The anticipate CDI. submitting study anticipates ibezapolstat monitor using vancomycin, gastrointestinal as Leiden selection of our has Center to at The Phase recent of is of X IIIC microbiome antibacterial a company. Infectious with of application study collaboration analysis for target to pol Novel facilitate further IIIC a XXX metronidazole innovative ibezapolstat’s urgently of completion to accelerate Phase gut this program. of indication, do we vivo changes clinically lead expand on emerging funding under development objective funding Medical model $XX ACX-XXXC of least human September was the in physiology. fidaxomicin, at ongoing second X consortium these data for candidate project are the quarter, this our to Acurx trial This for lead Gram-positive by to very University University treatment of they're the costs after the its partnership funding of Center our through product to laboratory application Xa the this systemic Xa positive DNA is Our non-diluted ex XXXX scientific by cover Phase submitted needed. vitro both University of with classes ongoing. $XXX If support Acurx the company funds in would for research Acurx’ for this with Center reimbursement its to clinical University and ACX-XXXC. all we the where year opportunities clinical studying study at opportunity certain Medical in Leiden our and half of partner molecular binding of million inhibitors. inhibitors the Leiden dimensional structures University DNA consortium Medical grant three continuing G&A

Shawah guide our to financial Rob? you to the our for CFO, Now, call the first results of to quarter I'll of Rob turn back the XXXX. highlights

Rob Shawah

Thanks, Dave.

included $X.X to first to increase financial to million $X.X quarter shares ended XX, ended this a million our release XXXX. $X.X which Acurx as ended compared insurance compared million to due and for The $X.X Our March March XX compared of fees, in per is XXXX. was cash quarter earlier quarter $X.XX to loss ended for $X.XX increase million trial Phase March expenses million, compared for related company back with ended the due quarter ended loss diluted three-months XXXX. in The The first that, million spent to of a XX, or primarily call the March Cash issued million for three-months quarter operating the were on consulting for $X.X outstanding for net the administrative $X.X diluted was increase totaling costs. for General costs. $X.X was March Research the March activities. the XX, as and per legal, reported million Xb million, expenses Dave. March on ended XX, December $X.X With XXXX in for million, XXXX. the were to XX, activities company share The primarily $XX.X share morning. over of ended results professional the quarter had of $XX the I'll were XXXX. XX,XXX,XXX turn ended XX, press in approximately March and XX, the XX increases used net and March XX, of or quarter XX, XXXX development related development an research March costs,

David Luci

company very and you We enthusiastic to call open months. us about I'll thank updating especially building pleased first we're And Acurx’ XXXX. joining progress questions. this momentum year coming to Rob. our look to now this the strong continuing Thanks, you forward in the all of for of quarter We're Operator? report up in on the the fundamentals and for today.

Operator

from you, go [Operator ahead. we Please sir. is Maxim The question first Yahn Chad Group. Instructions] from Thank have

Chad Yahn

on Congrats Hi the guys. quarter.

than setbacks other the as other has was ibezapolstat, given advanced, I summit antibiotics there in space particularly the So, are any had? wondering competing

David Luci

Well, question. thank you for your

much called to aware private Now CDI. we anywhere don't antibiotics as a any the a is we that's are development Crestone near we're they where There than along yet. that far other data in but of, R&A are are phase are that efficacy earlier there on company we in have product treat no as understand

in primary niche So, backend earlier targeting subgroup to the their are. we they're the much data do announced Phase a and parsing a of that frontline. there's their attempt diff looking X And longer also toward a that we Pfizer C. and but patients, endpoint on just that recently no failed player be vaccine no note the at –

The as program also failed the X longer the C. really for C’s have parted XXXX Sanofi patients kind summit’s failed. no online failed well. in treat a So, tried and candidate. Pfizer vaccine to of us and that back diff is as vaccine primary endpoint Phase considered

Chad Yahn

with Thanks progress on Pasteur And Act,? Great, the the great. there. any then updates also,

David Luci

organization that very with The was an the affiliation through working approved. close recently and part Act bioindustry of our it was understand that Pasteur is and the bill antimicrobial group omnibus we

I late think scratched March, news. and and instead, war and a Russia inning] national shortly [ph], [ninth by between hit of the back in kind back the appropriation that and in after was replaced got it in Ukraine, the the defense game

the most Republicans. approved support, be including that believe regard will the we Act year. legislation bill along industry later Nancy Pelosi in Democrat of part know So, some that the and on folks the with this Patty bipartisan that point Pasteur in And several other at do side Murray as has

of bill. are Some whom the sponsoring

certainly like new kind and be serious for with all infections. antibiotics for QIDP but Pasteur that's beneficial ours passage So, threatening Act the would company class know that's life tremendously the a of of incubator now, treating any really of we

Chad Yahn

as then and one. what could next, potential would inhibitor? Could the be Thanks. pipeline the about of pol just also, the you last your oral, And the is strategy well and IIIC Thanks. guess And talk in intravenous, that move a I you as having pursue? Great. one

David Luci

we Yes. And drug is fact, in next strategy that ACX-XXXC, the with are in the pipeline. which pursuing

development the optimized going can We're inhibitory [indiscernible] lead then IV. at IND close very XXXC. new to minimum the working to between bacteria preclinical and And as is we before XXXC is We both. and are two it's to because able terms of enabling be of be And the programs. the be in we expect that's that similar process say We [ph] lead we've with to discussed lead the to up in on yes, optimization and data concentration expect [Cubicin] work. optimization steam kill. really picking into oral half ACX-XXXC stage second Very

bacteria, infections so was [indiscernible] IV. and trials is same but be blockbuster drug, if used for same we was well, only it And go the should but Now, the ours target IV. the we oral

gauntlet] to course subject, So, than the be if [ph]. bigger get anything, [R&D it through of should drug having [Cubicin] a to [ph]

Chad Yahn

Great. Thank much. you so

David Luci

Thank you.

Operator

[Operator Maxim Instructions] from is The next question from Jason we McCarthy have Group.

Joanne Lee

for question. taking Hi. Thanks McCarthy. call for Lee the This Joanne is the Jason on

Regarding your Phase on size be Phase successful? maybe Xb the some and of color program program, would be just shed what could should ibezapolstat a the X you scope

David Luci

the Thank you, Joanne. Thank question. you for

or meet So, X it's a assess that have the to finish to with do what designated and or until the qualified X size and FDA that Xb would as be make mandate, to one scope what just in XXX are able Phase and disease It's the but with one if speculative, track we the like trials. done two may products, our Summit. early of strategy, or would the may somewhere data may exactly it's whether we have patient to bit be guess infectious programs trials two the Phase range. be possible in is we have very able do then and possible understand fast to or and we setting in trial subject trial doing we Phase to X and a a as X other Overall, do going determination, products, this we patient XXX Phase to

Joanne Lee

That details. Great. the Appreciate was helpful.

is share drug for anymore? current CDI the like used what into for if management, you drug on, moving that could be does your with ibezapolstat you know mean a thoughts Thanks. will frontline just And vancomycin So, therapy? next guidelines approved,

David Luci

problem. No Sure.

and indication FDA who the like an treat other And because that think that's IDSA it it's ago. potentially and approved of market, was infectious CDI oral because target the we treatment understand even through society that's CDI, Guidelines in Pfizer that's a likely draft selected Summit antibiotic as guidelines disease we become an to were line of be As frontline clinical the couple Much Sanofi from vancomycin folks the vancomycin, like they blockbuster. or have treat from billion those why removed very a $X.X CDI, therapy a and next therapy. will vancomycin is get very And if front they would a to therapy with list. recommendation that a to knew advent they removed America of vulnerable years metronidazole

Joanne Lee

you them today more Can And but infectious potential know Thank And about Pfizer? last Great. me. Acurx back for particularly touched partnering briefly opportunities? to pharma earlier, that. does do talk for you about I this you CDI, in you one how see coming interest before? big think disease on than

David Luci

discussions. We will and I every our potential think think, when of opportunities partnering have out, come day, we don't ongoing who we know

of the but If the space, they're the order niche they after in but space they announced over, obviously, there frontline vaccine that, work therapy effective. get have the product acknowledged bid you fully additional want do biotech] so article a little value recurrent read for because the that's their stay indicated therapy [first see out is multiple the space intent its remain there's Pfizer failed, in to to CDI even that And that they Pfizer bid they'll to for as given for CDI to in cases. that with in [ph] frontline

after sure the yeah, before we're So, pharma active all if if have would that deal. deal to to sure that's or the it data. be discussions big not we lead a and data leads we're where go. to a with deal, ongoing that Whether a going will not And

Joanne Lee

the Got questions. Appreciate your David. for Thanks it. insights, again Makes sense. taking

David Luci

We No problem. appreciate it.

Operator

that for stage, session today's further [Operator the Instructions] and Ladies there your question-and-answer participation. At and conference you no call. this Thank questions. are gentlemen, concludes

disconnect now may your lines. You

David Luci

Thank you.

Acurx Pharmaceuticals (ACXP) 11 May 222022 Q1 Earnings call transcript