ACXP - Earnings call transcript Q3 2021 | Acurx Pharmaceuticals, Inc.

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Operator

[Technical Difficulty]

David Luci

Thank you, Rob and good morning to everyone and thank you for joining us on this morning's conference call to discuss Acurx's Financial Results.

During today's call, we'll review our financial results for the quarter and nine months ended September 30, 2021 as well as some key corporate highlights, and then we'd be pleased to take any questions. In the third quarter, we continued on our critical path forward initiating our Phase 2b be clinical trial of our lead antibiotic candidate, ibezapolstat in patients with C. difficile infection. activated begin trial this have anticipate and we to enrollment month. total, XX sites clinical we In

Our as more clinical clinical of the development if quickly administrative June the inhibitors. trial trial aspects continue data of close Xb Conference as team late as process our we Phase necessary, to development C. is to than now getting onboarding quarter. we the complete reiterate of XXXX, clinical third Phase IPO of working to the additional possible. to additional ensure resources in well to -- with Scientific patients enrollment shortly pipeline difficile allocate be We closing cash after Xa backup presented to trial enough in completion through of sites the from of have added, In on infection the as our ibezapolstat the IDWeek with advance at that polymerase IIIC parallel, the

microbiome effects Actinobacteria microbiome of may seen ibezapolstat patients be during in recurrence and including and of rates. data species X and a therapy effects overgrowth from anticipated including of the presentation Phase Professor program, October poster available patient were our newly Garey, aspects outcomes, Garey early Phase changes volunteers, with Kevin clinical that Dr. trial presented noted Xa Chair, to predictive XXXX. ibezapolstat microbiome begin in that phyla Firmicutes observed of Dr. Houston that Pharmacy indicating our confirm microbiome Principal for University scientific low Specifically, clinical in of the beneficial Investigator and favorable healthy in results College completed

trial the after Annual the Diff on International Xth Garey by Xth the from Dr. reported data was microbiome November quarter. completed of C. Conference Phase end third the Xa Additional at

in of acids, phyla microbiota, data and is data reinfection. overgrowth -ay demonstrated bile Actinobacteria colonic low to acids suggesting C. Xa secondary and in decrease very to gut the known ibezapolstat. favorable of these be patients the scientific of as future were diff treatment bile recurrences more primary regimen the may importantly, evidence complete measured in in primary observed trials. of XX with treatment of with acids, C. ratio by provides low increased increase a bile We after in day of well during of we each the a therapy. remain particularly managing as both infection, with healthy Very while believe which three eradication risk excited which treatment care dual emerging and C. long-term a treat Moreover, exceptional with species, patient's Our acute concentration impact show microbiome, for is of Firmicutes ibezapolstat an using about difficile diff to the antibiotic appropriately Phase ibezapolstat the correlate secondary

ibezapolstat. Medical program bacterial in the in further the received product announced R&D pipeline action target the Holland, commenced against also Pol with inhibitors mechanism Leiden antibiotic Holland which We including to grant enzyme, a which our previously of Center evaluate University pol IIIC collaboration IIIC Acurx's from is of DNA the of Health

through our September to quarter in Chief August results the cause. care heighten quarter, Microcap H.C. Emerging promote you to joined third and third our resistance, Growth the Financial guide Working health effort of and policy of Rob participate the of perspective XXrd and the September, participated Global will the Wainwright for XXXX. August including Acurx number in over to a awareness now critical Conference Officer turn to Group in XXXX Antimicrobial and to Russell changes antimicrobial and a the which joined we addition, pandemic, in I support call highlights In in as Conference XXXX. financial investor see the Rob? Investment Annual back the the conferences, next in Index finance the many of to From Shawah, the

Robert Shawah

Dave. Thanks

the $X.X nine from of compared ended the one company's $XX.X Research September of Cash million is million, as for attributable months -- research increase million operating primarily As XXXX The financing on million, costs. for was months initial to ended and million offering earlier, our to $X.X were September Phase included IPO-related September with XX, ended cash was totaling XXXX. million of the $X.X XX, activities and mentioned. million. of period for months September proceeds related approximately XX, months the $X.X $X.X public million expenses was net XXXX operating initial XX, on nine XX, increase issued to used activities offering XXXX which of for was provided three of XXXX in ended by nine approximately for the trial offerings. in XXXX XX, $X.X previously activities. XXXX financing quarter spent offset our XX, expenditures related our $XX.X XX, was activities to attributable were placement the and Acurx nine-month $X.X expenses September nine public proceeds million of for Cash ended quarter nine on million primarily which and September development represents from financial million, compared by December the September an $X.X months Cash the XXXX, months Friday. provided ended development net cash results the in as cash cash due ended three for mentioned which press $XX.X the to Xb private ended months release by the

trial XX, ended development XX, months in was insurance, XXXX. to for for professional $X.X to three XXXX. September The million due non-cash compared were and ended September for and to the administrative stock-based legal compensation months increases and expenses Xa three $X.X and primarily which XX, XXXX, million XXXX costs, The fees, is September $X.X the September in General million million research to months the ended related decrease compared nine completed Phase increase due the For XX, costs. ended $X.X nine expenses was were months XXXX.

to fees, $X.X months general costs. the diluted nine non-cash XX, months million diluted $XX.X months attributable ended the of primarily stock-based the million the million $X.X for compared to stock-based a XXXX $X.X a all XX, diluted is the nine ended over administrative for reported XXXX, for net XX,XXX,XXX $X.X director per or million $X.XX The diluted increase XXXX, I'll nine company call months the September and share for three per and ended expenses net in compensation, compared September company to had net Dave. expenses months loss months September general XXXX. professional reasons and legal net XX,XXX. ended million ended and in For XXXX September increase The to a September nine loss $X.XX outstanding share mentioned. compared insurance, previously XX, $X.XX the the fees, back XXXX. shares that, as September turn an This administrative per of XX, The share XX, or for a million ended share of $X.X XX, or of for loss With per loss were September of three

David Luci

XXXX. in very joining going you, like call. the today's and Thank pleased the momentum in activities we the for conference Donna? forward would for up achievements third to and all I and building fourth for us call thank quarter to into quarter on open look We're and to now Rob report Acurx's you questions. this earnings

Operator

and you. go Maxim Ladies Our Please open Instructions] question from now Group. questions. Jason the Thank of gentlemen, ahead. is is for [Operator floor coming first McCarthy

Jason McCarthy

pulse know-how, to David last think guys looking drug, questions. with does, as you talk can that But the taking the can be component have a the years little type landscape has little microbiome package, since for about Hey, part and superior, particularly microbiome guys, the at as how who microbiome that you thanks of really data about bit matters. We just more their a over couple bit and that? a changed you you that openness of maybe it talk a it'll knows. has data emerged, FDA non-inferior a

David Luci

better Xb. if it than which ibezapolstat investigational that the a C. endpoint to help speed and is the up diabetes, endpoint has the with the cancer, with microbiome. Based healthy microbiome, confident the regarding in become programs avoid case, we're We Phase prominent more the microbiome data restoring in including the and of back and in the our microbiome significantly gut all program, secondary for Phase -- That's assuming a is you, it's clinical X. of working Jason provides do folks, that going industry and FDA to standard-of-care. almost Xb Phase bacteria an to kind have on that the in superiority We thank in in shows to success different equilibrium protocol meeting a an our of infection. know meet to Diff position modifications a superiority vancomycin, a for that cottage today, recurrence our types, to with Sure you that therapies the tune we after the endpoint, we're and we have diseases And to forward endpoint. look the get successful with And fact, Phase we Xb trial the with groups build in our in related on different to highly protocols for that in agree the microbiome FDA endpoint question.

Operator

did Jason, other have you questions? any

Jason McCarthy

I myself, figure can't Can-- still it muted out. Sorry. I

David Luci

If I may.

I think an it's investigation.

exploratory it's an opposed as think I endpoint to--

Jason McCarthy

at Can like microbiome beyond get diversity, looking you sufficient? alpha need is just more on something that side, use Yes. analysis? phyla to you do the broad granular Or

David Luci

will And FDA microbiome addition analyze but of FDA in in aspects the go that We be looking diversity that, direction. other prepared to phyla we are be think analysis aspects. the other at alpha in that changes sufficient to the the for the we'll should purposes,

Jason McCarthy

just is long-term the which of last Okay. view And more a question. question,

activity and their not changes sufficient sure and need we're if would antibiotic trials, And that's Phase tracks in with the we've one saw of comment be is you quality -- around out of that's and what Phase know could on to size two the Xs? that its and Xb Phase where that based or going. reason really was the data Phase as two potentially Assuming I space could X Phase where seen to the on you I'm Xa, there, some X blending serve the another don't the Xs in asking there you Phase

David Luci

interesting out first in Yes, was find quarter. not understand and kind changed we're But I endpoint it's when interesting it more product -- understand the that we're as already have we Phase that But during don't completed. going designee. infectious the to and and Phase somewhere X possibilities looking Phase or But information enrollment mid-course designation going on meet have we that Fast-Track we which -- find understand. either. do that's may FDA we at we X and are the an two or the we of is do be sure to We we're qualified Xb quite agree, out point the disease the we'll it's studies the where period, after Xb FDA

question data differentiated But our numbers cure into be break from patients, are hundreds or and to number able so XXX the from the vancomycin X we it two. microbiome some -- So, be XXX trial likely that are X can is whether the two study will in make do impact in one events, argument Phase just is enrollment the trials. we put one that of of hope in patient patients, to the in either Phase to that rates patients significant registration instead an

Jason McCarthy

Sorry.

sure further Just few the that that in are other out certainly are they but literature, really of and really or they be not other two there's But to you a people. antibiotics to there? a own, not seem advanced behind. at that most Phase they assessment? clinically. and seem program Xb If dig fair I'm much clear Is the your they're where a programs it's there's Outside be briefly, are those stage,

David Luci

Yes, that's our understanding as well.

Jason McCarthy

David. Great. Thank you,

David Luci

Thank you, Jason.

Operator

Lucas Private ahead. Please Russell, next a Investor. is Our go coming question from

Unidentified Analyst

David. Hi

investor. a of questions a last one answered and a I'm of Layman little couple but little a bit Just a of more the bit,

and Just of of kind microbiome to And the complete? be then, data kind kind do you in bile company? trials to when terms, could explain the again, is expect acid me of to Layman's how the of you enrollment important

David Luci

quarter is back I objective enrollment quarter's Lucas in Yes. for Xb tell and that can question, this our the in welcome to Phase Thank XXXX. you second call. the trial the to complete you of

in in XX enrolling Now, ability including XX to trial have to to the known activated five we beyond that up higher the clinical be. to first evaluate we pace quarter timing enrollment it and we determine plug to where the centers high of enrolling we've we want the we're sites that sites continue will four the and the should already, have isn't going

an because can impeccable we've when real of generalist look data trial, early to was due look a or policy patients it but publicly by we numbers. through quarter. the due on do was microbiome cures. is that's easy XX at in our patients, to in which in to So insurance us a aberration kind no at And XX that question, important or And with is ensure cures XX, kind that data years small for But cures to second -- the Scientific was to data has safety think XX clinical halfway the and it's say the to And XX and you success the of vital success, Board complete what Advisory patient plan issues, vancomycin, scheduled of investor, real is at this that terms of trial view. as of in to is comparison an Xa the data, built to backup response terminated patients very tolerability enrollment the it's sustained is that Phase XXX% we that microbiome and is XXX% a Xa XX information for Xa be XX only not -- trial, microbiome XXX%? available tells part an the

take three after treatment, there's XXX days, of three vancomycin, depletion we're known sustained infection and while is difference. microbiome, on we're those the of over seeing the is primary we're the the infection C. recurrent patients data be those in that curing in part diff acids. C. why among what the where diff scientists, restoring large And days healthy we're which the So, the in it's dramatic supporting seeing gut cures who reason a also for that bile is times have the bacteria to

recurrence. abundance So, an a having very of bile with of likelihood correlates acids secondary low

data also even disruption are the recurrent the which not opposite of enough in to we the of and primary XX colonic the primary with XX acids And again, But colon secondary seeing is proliferation of end diff restoring to of are why secondary of days the it's puzzle vancomycin bile acids because a favorable a acids the XX for bile why you're that C. another Well, so days to So, piece contradistinction in in of we're we after. diff of the and after treatment? are of the bile avoid secondary ours. those after of proliferation for C. microbiome, presence vancomycin cures XX ratio a healthy ratio infection is has primary experience, talked the and about microbiome. treatment

recurrences, recurrence scientific the rate they're vanco and yourself, ask are recurrences. have scientific for to So, past Those of XX% opposite lack of century? the half reasons when the our you why does over for XX% reasons a vancomycin the kind

Unidentified Analyst

exciting you, Thank Thank you. stuff. David. That's

David Luci

Lucas. you, Thank

Operator

At this floor to closing the back I'd to Instructions] Mr. for comments. time, Luci turn [Operator over like

David Luci

time. for you Well, joining exciting It's hoping we're financial at thank to time XXXX for you earnings we the call an be your Thank in around for appreciate all late forward the thank you, in Acurx your or March much. this Pharmaceuticals involvement And for look and of conference company. we news quarter's exciting Donna investment update, which next and and and will us very some that call.

Operator

concludes today's your for thank gentlemen, you participation. event. and Ladies This

of at may rest this day. and your enjoy You lines time your disconnect the

Acurx Pharmaceuticals (ACXP) 15 Nov 212021 Q3 Earnings call transcript