- Earnings call transcript Q3 2022

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Operator

Greetings. Welcome to Acurx Pharmaceuticals, Inc. to Discuss 2022 Third Quarter Financial Results on November 14, 2022. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. Instructions]. [Operator

this introduce recorded. Chief your Please ahead, reminder, my is Financial is go to pleasure host, sir. conference a It being now Officer. As Rob Shawah,

Robert Shawah

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

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

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

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

David Luci

And call financial conference morning, to thanks us joining Good results. Rob. review our everyone. Thanks, for on this

for randomized we C. to be the the XX, trial cure compared to to third vancomycin, cover clinical the our is the XX-patient quarter, In at corporate we'd follow-up financial questions. end is The with and of be of trial, at treatment, treat ibezapolstat of call, Phase antibiotic sustained The trial any cure clinical measured ibezapolstat, treatment the of also is key is blind will XX visit. patients we difficile results standard the some pleased XXXX September the take Since the care continue date double third quarter a one-to-one non-inferiority endpoint and then today's a more Xb During double-blind review the ended patients And known primary Xb candidate infection. Phase this for the trial. our of trial endpoint clinical Phase oral secondary clinical trial enroll the CDI. leading of won't until in highlights. to Xb oral end results

ibezapolstat to However, between as on demonstrated, with includes event be vancomycin. conducted non-inferiority for endpoint ibezapolstat will to vancomycin operationally protocol signals analysis The impact is the and In safety of trial proceeding the comparing recorded to-date. exploratory the expected no superiority. an the microbiome further test is

the with following. to up orally exceptional further against participating we therapy. the using eight patient's dual impact Acurx's due microbiome, of trial on U.S. pol The sites available excited product of resurgence were for about the approximately trial the Medical Other continued Holland in this of Currently, evaluate shortly with ibezapolstat is open on trial thereafter, remain company Details oral possible University while highlights has sites we We candidate antibiotic of sites. C. infections. sites enzyme, for antibiotic impact bacterial of our Web and of six some to October and additional time. include difficile from its for inhibitors Center infection, is believe care systemically treat gram-positive infections, pipeline, XX during or collaboration there cases the expanded poster R&D to Additionally, expected slower U.S. Xb D.C. the COVID-XX each the trial in of target clinical onboarding site. quarter the lead which long-term in appropriately at particularly of managing Leiden enrollment initial our which the IIIC microbiome the DNA key than are are mechanism-of-action at bacterial presentations in and third XX our from presented the Washington both to of enrollment IDWeek sites XXXX, number the and aftermath trial the in in to Phase and

ibezapolstat at continued of first-in-class are ongoing. program, our in various of to of treat follows; 'XX of of to October aspects fidaxomicin kinetics development conference Secondly, killing killing in vitro and been favorable MRSA, Comparisons preclinical The the IDWeek patients and ex to recent two infection of of supporting Resistance and infections of of difficile killing with to ibezapolstat the demonstrated Houston in portions ibezapolstat and conferences concentrations, laboratory Antimicrobial by University the the at development have results certain in both and difficile standard effect to the Society C. its study presented presented comparing bacterial this September has ibezapolstat C. fidaxomicin treat 'XX. company were Presentations and results to caused high has at standard that in of scientific antibiotic scientific currently prominent the completed America analyses. treat compared metronidazole Conference at antibiotic infection. second of vancomycin, care vancomycin, effect annual using Anaerobe of is metronidazole as Certain vivo which

trials at who approximately difficile clinical warrants. investor million trial reiterate, and anticipated Month the raised of of and treatment, $X.XX U.S. the sites institutional the invested of trial before share per total educated company's the C. we shares offering three Control sites exercise continue In XXXX, Additionally, environmental Lillis onboard and for investor month of both of To and the $X.XX Foundation we work designated the the with stock of U.S. common by proceeds $X.XX executives. institutional supports July total direct company's Centers in investor November registered one and C. per C. new totaled Peggy to and and the of active Financially, X.X share trial per as and $XXX,XXX. institutional the warrant U.S. the common the of diff Awareness a share recognizes executives, an July of X,XXX,XXX and Acurx pre-funded purchase price a as U.S. by a Foundation the approximately Disease transaction, for XXX,XXX consummating for million worldwide. the of for Prevention, coverage infections in safety to an issued and the XX for the advocating company to target the $X.XX prevention, executives difficile at gross 'XX, year. increased three share per total $X.XX company with of clinical of sites for clinical end number in Warrants

$X of of company to antibiotic to funding up In be million, filed X addition, in party by of five program, funding million trials. the approved, XXXX, right MRSA April our portion XXXX. $XX company's provide if October funding this the years, decision The the ACX-XXX Phase and which, second of for in clinical start the up treatment a non-dilutive of approximately expected targeting for for would infections period would the a grant

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

Robert Shawah

Dave. Thanks,

increase this the development increase quarter the for were XX as totaling Xb related Phase was $XX.X results December issued for September to three the XX, earlier September XXXX XX, and three financial ended Our consulting third our third and compared in September ended $XX XXXX. ended for Research of expenses XXXX. were due The million to the an September to quarter with on morning. related included trial company press costs. million months compared XX $X.X in release $X.X costs ended XX, million million cash months The

for versus primarily related expenses in current ended in there the costs the administrative million a estate. too. months three million September XXXX. an Phase related and were The decrease General to a company's for months $X.X ended was legal trial nine million nine-month decrease to September related months ended in with decrease the the XXXX. XX, research offering XXXX, compared costs increase the months expenses and XX, September September the property and XX, increase consulting This $X.X for three and were in XX, compensation period $X initial due fees development Xb to XXXX $X.X due public For primarily nine million to intellectual the company's associated share-based ended was

$X.X to professional over ended ended XXXX to initial were and diluted months $X.XX nine share for nine the of September months attributable for decrease months and XX, turn $X.X XX, XXXX, ended for of million was partially loss outstanding months million the of XX,XXX,XXX three mentioned. of net the the With the that, ended as million or company the a per $X.X The insurance a per share $X.XX of $XX.X XXXX September XX, fees $X.XX September net call I'll XXXX compensation back share net increase million expenses ended diluted nine offering, by XXXX, diluted compared shares The offset nine to XX, in million months three loss $X.XX reasons for for months September or a $X.X XXXX. costs. per $X.X to had the an company or for September September net a diluted versus previously reported XX, million the a administrative decrease and Dave. ended per The share to loss compared company's or the September in XX, related XX, loss XXXX. general primarily stock-based For

David Luci

in even in look of over this today. you the during Thanks, 'XX. and us now continuing joining to forward months, report for very the questions. we're pleased update most and Operator? and times especially all for you so. our to strong momentum progress call to to these as of I quarter Rob, about We Acurx's fundamentals do enthusiastic third will challenging building on turn coming we We're

Operator

you. Thank

now [Operator Instructions]. question-and-answer will conducting We be a session.

from ahead. Please go Jason McCarthy first Group. comes Maxim Our with question

Jason McCarthy

Thanks David. the questions. taking morning, Good for

more update Phase XX, sites. added provided I Just you lot you've had on think where Have numbers? guys the Xb terms correct? in any of that C. you enrollment the on a the is trial, diff mentioned target's in

David Luci

target is randomized. in patients once protocol XX The Yes. the

planning XX%, X Board there, data, the Monitoring data there no would the is, Safety terminate that that company insight and there's particularly may looking to early I except As Data we've like we so Phase not makes if -- good, we is we're mentioned, to trial, the the into that we to and be to get data Xa aware for us blind, ability only that. and have announce that But be an an double recommendation. activity Phase they if our caveat add Xb will a or previously when the enrollment. And are it's possibility. or The extent is doing whether opportunity

Jason McCarthy

Okay.

had you path it forward there? good So second target? the There's again particular X on get what a and I September, data What to And in think indication you What mentioned preclinical study? could does some like targeting the in back look October. to MRSA. IND Phase program, is

David Luci

abundant bacterial So most of area the both and working be the structure infections by we a few -- MRSA abscesses, oral be in on an most infections would formulation. are indication caused one skin the and That's IV an of targeting abundant, initial not if MRSA. would U.S. target And the skin

pay have the preplanned So Then looking of as these complete XX up balance we're $X that into would go five would I to are X. steps years optimization, to or of million that grant million. costings the of in or five the of scale And support XX% as tox lead non-dilutive the years we pay on should get conduct a it order if IND next say so we And submission. would these manufacturing to about of Phase costings. well for, some [ph] to the work we program

Jason McCarthy

outcome expect submission correct? grant that you Did I the of or And that April. hear right? Is Okay. in that file

David Luci

Yes.

non-dilutive we've the party. the been out into of then So if a the April XX at with At find we of if grant. And is consideration that point, period contracts will when second that hear negotiation approved. November, end round funding for we'll get there's for we

We years, interaction out. funding had the expect since the before -- for steady party We've we even even past will. the with RFP before three came

the middle we And our we particular right fit grant. So RFP. the we're particularly of about for hopeful feel this candidacy down that

Jason McCarthy

Got Congress, working PASTEUR the it. that updates And just on the the in Act? quickly, was program any on government

David Luci

we the the the DISARM Act surface, through PASTEUR working beneath understand antimicrobial like still right and our as with it, are interaction Act group. The

of and will yet. couple election that the in both organization Congress. But global the with in in up just we've very the markets, For or be that industry the the bubbled the market, are hasn't stock it both the back approved one new bio past months the and AWG volatility its confident seen way

being mentioned, Act made As And on by is who the purpose week. this last her thankfully support. PASTEUR reelected bipartisan Patty side the way enjoys Murray, has to Democrat championed for

infections all treat hopeful that So passed. be particularly patients valuations the PASTEUR really first stage life in or the will are class. of antibiotics And with threatening we're would QIDP increase serious that for Act that novel infections, developers R&D

made of last It tailor bill ago six at inning. spending ninth minute, PASTEUR. been defense about we've for in that feel a scratched we the favor was months So

still pass. we're Congress, new it So that in the hopeful will

Jason McCarthy

the Got morning. for Thanks it. taking this questions

David Luci

No Jason. you, problem. Thank

Operator

[Operator at questions no are concludes Instructions]. this teleconference There today's call. further This time.

a may you You your for have great line disconnect Thank your day. participation. and

David Luci

Thank you, Victoria.

Robert Shawah

you. Thank

Acurx Pharmaceuticals (ACXP) 14 Nov 222022 Q3 Earnings call transcript