TLPH - Earnings call transcript Q3 2024

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Operator

Welcome to the Talphera Third Quarter 2024 Financial Results Conference Call. This call is being webcast live via the Events page of the Investors section of Talphera's website at www.talphera.com.

You may listen to a replay of this webcast by going to the Investors section of Telfer's website. I would now like to turn the call over to Raffi Asadorian, Talphera's Chief Financial Officer. Please go ahead.

Raffi Asadorian

Thank you for joining us on the call today. third a financial press our business and announced in updates release. we quarter results XXXX associated Today, With me today Officer; and are Vince Angotti, our Dr. Chief Executive Shakil Talphera's Chief Officer. Aslam, Medical

and with annual website Exchange can call, remind current filed statements. Before addition future the within with results operations refer risks discussion now and the These to Please periodic, on that within the we documents and Securities reports want laws. of Commission will Vince. likely section. I of hand to to the of company's securities our release These statements begin, during forward-looking Investors found Talphera. be the I meaning in such the this our and a forward-looking we the to federal statements uncertainties for will call risks make the listeners associated forward-looking press involve over regarding

Vincent Angotti

you, Thank you joining call. us afternoon, the on thank Raffi. Good for and

me the congratulate Palmer let well-deserved welcome her on time, same First, and at Dr. retirement, Dr.

his onboarded. that quarter, sites total In were happy to with I'm multiple registrational Aslam we ongoing provide share progress our patients screening in large inaugural institutions five active academic like that the and completing we trial. being a have quarter, trial NEPHRO we're now communicated seeing this CRRT on to of Today, an the clinical study. Last update I'd for the to nafamostat patients chart earnings call. Talphera already

the to of sites additional active expect the also screening quarter, by the clinical two begin end seven We this bringing clinical sites to total year.

existing of year. but Note the activation of we the completed enrollment was place next August, new date, to to anticipate to guidance execution plan we with expeditiously quarter, enrollment onboard on In each several rates in productive plan to and are study sites study the announced trial prepared the to study specific additional sites, be completion not we're that patient provide and improve While improve enrolled. first enrollment our at providing numbers we that don't sites. initiatives on

reminder, the patient CRRT of first XX a the the trial time the how primary of endpoint long on is patient hospital. regardless mean completing over the the the CRRT clotting remains activated As after only XX on hours in hours with measured

XX-hour as While time rapid trial. waiting it for the post cleaned patient a allows PMA by the to participation instead quickly also submission and can completion, database trial trial months the for study reduce completion from locked helps be many of

expectations. have clear, of original our met the timing to not enrollment Now activation the rates be and sites early

now certain we've As changes to over like a result, moving it variables to made forward. I'd to Dr. turn

trial NEPHRO the many talk opportunities Aslam, identified a and practicing trial, about experience and to in who improvement. continuous for has and the as years he's his design nephrologist status assessment of execution the of

Shakil Aslam

you, Thank Vince.

So numerous [ sites with engagement screening current investigators, nephro our and with and we processes clinicians after to and improve the patient ] opportunities and enrollment. working identified discussion are optimize

PI are PIs This hours the the before once sites enters order to orders screen a with automated text study sent to to window to to for before X capture allows and the started notifications implement For the initiated. working we for example, CRRT, patient on in X consent for the of policy. the they patients CRRT doctor is CRRT

might electronic We generations identify be medical towards records from the are also CRRT. automated implementing who requiring to heading report patients

kidney ] such certain are urine and as CRRT. [ indicators abnormalities, output, used numbers as variables function to initiate which example, usually For laterite

lines ICU sites, as medical time we have to times process with sites, current we with investigators on onboarding and are that administrative help in us these also population, emphasis we activation. To the are validate for working Based and confirmation site large these a that historically access that on sites those contracting also short sites party a learnings this such new the addition with can with with the contracting to officers. broader our that, from of This third further sites. the are clinical CRRT with ICUs. effort, potential In prioritizing identifying additional time with high-volume centers have from

elements In XXXX. sites improvement, and part our study We time. some bringing we of addition, on changes designation to breakthrough are experts study enrollment our to shortest consulting as possible the in completion X by additional continuous regulatory early leverage to potential implement facilitate anticipate design to

reminder, of sites a expanded FDA to the quarter, from last trial the number As maximum XX XX.

as for need in in back Our occurring Society confirmation to alternative interest Week through Vince outreach CRRT, events engagement discussions Nephrology's always unmatched participation now. continue well clinical of strong as targeted inbound additional such there have our to Kidney and need American use it during XXXX. sites for industry is CRRT we with clear a our thought the was an as I this of anticoagulant trial potential experts. I'll with receive hand the Vince?

Vincent Angotti

Dr. Thanks,

Kidney of the unique meeting alternative and as trial on and believe the momentum attended number lower confirming are regulatory year. With product clinical, Having nafamostat's reasons. and we in with the our we summary, the next for his to I'll reinforcing in Aslam. conviction clinical to more risks nafamostat, gaining thoughts clinical progress have we're hope potential well, echo share need have an In on related received, development feedback anticoagulant its information Week a the early for commercial a and utility.

risk of the and The CRRT evidence Japan published for efficacy an we're FDA, safety, patients. of this years with sites agreed know as to has around screening track trial XX are use that been to the the now trial the anticoagulant in nafamostat's beginning nafamostat. of Korea, execution for we demonstrate enrolling product's and record design South minimizing with clinical First, and

clear Second, review breakthrough times we provides designation which including have quicker path, well with access the response a us increased the with to a agency. candidate as product from and FDA, as regulatory

for we namely CRRT, and is [ where this currently the believe commercial mitigated anti-coagulation given risk being during of disadvantages Heparin there's always Citrate Lastly, we the know ]. used products

As that increases and no not to poor This the used us but use may Citrate of anticoagulants, alternative. I'll you though some no approximately additional to now blood hand X/X prefer harm patients. of of provide a other transfusions the the Raffi anticoagulant third have Heparin they or call time, Anecdotally, the to, to to of would even they during risk our result CRRT. continue results. they tell disadvantages these the of details physicians many is quarter financial dialysis, over

Raffi Asadorian

Vince. Thanks,

and expected capital the clinical at of $XX million Cash to study. is last operating to clinical the $X.X year fourth in operating quarter. $X increase million Year-to-date, injection to third study are of cash cash the study, totaled September of by million be cash lower combined is NEPHRO to expenses, It $XX.X quarter range, in excluding $XX expenses prior the the SG&A will totaled Full XXXX the and million required million be in year expenses NEPHRO SG&A offset third attributed or end the totaled $XX.X likely depending an CRRT million. stock-based compared year. the The upon Our operating from additional in enrollment R&D compensation expenses noncash investments rate completion expenses. to last quarter. the the

main it the to now Vince. investor, study. I'll as we Nantahala, progress their clinical financing continue turn to Our continued has back support expressed

Vincent Angotti

Constantin line any to Thank ]? open questions for [ you, might the have. Raffi. I'd now you like turn

Operator

Thank the from session. first from James Partners. question Instructions] you. the and of now Ladies question-and-answer Alliance begin line will [Operator Molloy we Global Your gentlemen, comes

James Molloy

found on optimization the was -- was [ by year. I do the any change I the guess And going end total change? X that's and getting why through, the the out as on more went. I ] optimization okay, on you drive granularity can new congrats start? Or learnings walk the here screening, of to Or XX screening a is year it make wondering the why and this doing -- it why you said, if to by you're there that of you were this here. please, the now we're from up on XX next And did guys running -- sites the enrollment that

that, us be that great. please walk could you If would through

Vincent Angotti

Yes.

Let the with it then I'll to question, start me turn Shakil. part of over

is what I and think part current you sites. have think is what it -- the what of with learned I asking happened So you're

the from meaning initiation. that sites the we've So had

acquisition In many now. the sites relationships. brought But sites and us program. numbers. these were that involved to enrollment projected that nephrologists up others, existing working still to they're world-renowned to the the Those of well-known, are with So instances, have catch the some these we are were they of ones

by So important, clearly, but believe significant the still that XX on forecast, with Shakil's gave be patient high-volume the screening the sites remaining going the they completion. And to on you and on your and to study them. patient the behind are contributors, specifically? to Look, point, can sites population, they're to these think Shakil, expertise, and I that we experience a FDA we're sites focused broader up us the population now expansion on feasibility it's comment with accelerate broader and

Shakil Aslam

Absolutely.

And have has been to screening. improve So initiatives number our engagement. one we several site taken

CRRT during and the their when staff put the sometimes activities. we and hours during are and always in PIs to day, not the this site are the the actual So and present communication recognized sites we missed review start other are And some pharmacy have are that we these all ICUs. They of in with in the not site, screening a are CRRT XX visited patients around begins. time procedure PIs to medical constantly these the process, also the orders

X that's a of So window to hours. about X

do tax for the notification the is doing pharmacy and PI we're enters these that CRRT. off IT their what institutions goes automated with orders to an doctor work So departments the with once that

] them family to X-hour can that during consent as patients' a the and which patient. they to team window primary So [ X- gives the as well talk

somebody actually a physician So having this to on of talk is before the and begins CRRT family CRRT study enrollment, then little way, becomes to bit which patients already trying instead for captured procedure the difficult. and

The injury shown moment, the days are help at less subsequent kidney you to other deteriorating physicians they're a their to few where or over kidney days really going thing is normal couple point think CRRT but had starts. particular to they need in that CRRT they're with days not requiring patients of identify numbers to and these than after a function is that be

help which at So us examples two optimize I least are process. those screening the think

know if don't I that your question. answers So

Vincent Angotti

provide on to Jim, and take affecting Shakil, I'm on about where common the and moving screening a further. do it granularity. how we are going don't a now learned and forward. more of those seen step Maybe are going to we've believe the little be you Why what those ask most it navigate to two commercialization we to failures,

additional that think would helpful. information I be

Shakil Aslam

Absolutely.

as and current as our well ] So ICUs, sites, a maybe heavy bit emphasis towards little tilt have they [ or cardic [indiscernible] ICUs.

And in so patients those of ICUs. CRRT require lot there's who a

However, their [ the in these kind requiring some typically and assist is Niyad. actually done of left they support, because challenge once is heparin. or the is devices. that with ] those poor function heparin, ECMO included heart [ function reason systemic done many up are them are with was of ] heart and on patients on very fail no which their with And really kidneys a be [ anticoagulant, patients, it's end ventriloqual is ] they for there to And

The is there patients of we bleeding population lot noticed have second who patient problem a postoperative this have in issues. that are

But be these it not are physicians perfect systemic once regional it's because for time, at thinner. treated give would who the and Niyad anticoagulant actually bleeding obviously anticoagulant any patients the going will these have blood heparin. same the want and patients patients active approved to you who with cannot to a as it's be candidates such are who them on Now

will because parameters process regulation although your being So that the and trial. those currently the big represents be in a impact perfect who commercial is because chunk Niyad the for to in to be this are patients one bleeding the get of will that fact, because the are that's patients we of actively proving patients excluded reasons from not Niyad. safety those FDA the opportunity are And study. biggest systemic enrolled are But of the who us of in who cannot

Vincent Angotti

regional want while nature. that to Jim, they been in that in data, it's overseas, it to patients it's proven Shakil's short the U.S. half-life and So point, has see that it in all the

be And so won't approved. that that a study the a once limitation was in limitation

James Molloy

the looking for forward? trial. at approved FDA of for follow-ups, in Then think that? And XX go XX XX majority? site. in year, that sites widely safety learning Do they I'll to a going are dispersed next per spread two quick bring to by sites over been that Are Or queue. will much back the more all how is hop of -- XX any XX, the Or among how out there obviously, the patients you maximum [indiscernible]? be the and be is does it's of you Japan. are end years XX that will that handful then assuming in evenly sort sites. is about data Obviously, And the XXX There -- across XX to admissible a and vast on it

Vincent Angotti

Why Yes. with question first start don't on data. U.S. ex your we the

So they the consideration , was when cetera, did into and developed. take the design that et study

to that. it I'll relates forward, As it with submitting Shakil on defer the to package moving

Shakil Aslam

Right. Absolutely.

later. So the events we Japanese adverse submitted previously data database from

significant really there aren't so Niyad. any safety with concerns And

as also systemic in it's given acute a well really circuit were it's So CRRT. in like systemically, some DIC which not ]. cases, approved indications those them, because for of they in as reported, countries, [ pancreatitis And those been have for

the adverse of none them based on X%. event reactions. were low rate of hypersensitivity close very So that than data, overall very, incidence to serious was other And really

in record the a of this some safety that long FDA So compound. humans there understands on is track

that, as which been are data animal studies, us exposure typical done and the In a studies drug preclinical be look that species, two development. we'll work submitting studies, levels well, have multiple and do least also And to at for as in early very done those to wanted well. FDA they was because fresh previous addition at to they wanted while a work back

I the think would safety overall, be convincing. quite package So

We compounds human for safety the are of more most will that than approval. have data submitted

Vincent Angotti

it it part relates skew end think across was I the the would on sites. potentially Jim, of to second And of question, your and the distribution as XXX how

expect and half of recent are again, be few. So sites board, sites lower more next Dr. the have some while year additional recently to first expected sites that on to initial first just, on the the than anticipating of board or the we in they're come coming contribute we're more And as the

patient surgical for ones large ICUs or medical cardiothoracic will different the ICUs CRRT. have that's a ] medical they're they why ICU ICU. mentioned, profiles patients produce from. The [ Aslam and ICUs, And the pulling versus potentially more

Operator

next from Your question of H.C. comes Ed Arce Wainwright. line from the

Wing Yip

Thomas Yip, Ed. a for couple is This asking of questions

patients of are subsequently discuss patients study, screened And you feedback CRRT discuss then either So enrolled? for or initial the the ]? can NEPHRO you percentage any [ and who successfully successions can from

Vincent Angotti

sorry, question, you of repeat I'm can the portion second the Thomas?

Wing Yip

Sure.

who site the Just wonder on if enrolled you can share are any feedback who or experience in [ ]. from are with patients studies physicians

Vincent Angotti

Yes, sure.

a relates half site. the screening, percentages the it depending mean, I on as of So fluctuating versus question all on to the particular time it's first

any So on cadence it's difficult real to that. you give

if that comment -- a an I nafamostat it's from think anything can you don't your experience, patient. know question important and realizing an from feedback on or don't that aspect is why the physicians have garner the Well, we you of we the Shakil, their completers on placebo

Shakil Aslam

Yes.

was the ] titration, a had least and problem. ACT, really in it all patients change. the at ACT uneventfully all target not titrating [ time again, very completed Physicians easy patients in to with So

So has blinded far, know so feedback But can it's positive. the very so reveal. there's been much study, from a we physicians or only

Vincent Angotti

candidate we've actively things think patients ideal the when Well, real there's our I those the Thomas, bleeding to about about who screening, reiterate more asking our of patients the I'll learned. two world, again, really, one excluded. it's And from requiring many be the to because we again, you're are just, nature in be again, ICUs time, blood criteria expect patients them are And secondly, system and the on for [indiscernible] Obviously, centers. coming different us. the exclusion the don't of ICUs an that's they're surgical device. cardiothoracic you the regional where two or systemic today in or remaining and on And want or

Wing Yip

then study. And NEPHRO the also CRRT for

next expect guidance Just we and well? XXXX also the can the as very data study wondering, given to also [indiscernible], complete short in year

Vincent Angotti

yes. -- asking you're So

So average with you're that completer a patients. reading goal. clearly and When our mean XX-hour I looking think XX-hour at be ACT look, these -- a would

even the of of is understand to I that from mentioned time think to PMA short. completion of the study it's we the submission important

or we'll have the organized, it It database We two all expect along. three data locked. be analyzed and will be to cleansed, max the because be months will

So that be would certainly our goal.

Wing Yip

us. perhaps the one further that from And screening to more mentioned and opportunities press question In then it release, was there improve are patient enrollment.

wonder what just So accelerate plan to enrollment. measures

Vincent Angotti

Yes.

ones are the think further I opportunities those mentioned. we

alert sites of consideration with the of the larger on he's patients the Shakil's get new relates physicians the As to identification early the on medical general ICUs. on for description we're early further the patients site having get the to to it putting the

Raffi Asadorian

I just We're And disclose. and mentioned like activity at, in yet add, not we're are we're design there other are think those yet not the release. things to in But some just looking that at point. there's study disclose prepared to that other evaluating ready what we to press that this that, currently things we're as

Operator

no time. further questions are at this There

over Vince Sir, So I'd the please like to to for closing ahead. turn call remarks. go Angotti

Vincent Angotti

operator, the our you, excited remain about to forward. hyper-focused long-term shareholder be We specifically of continue with we CRRT value, driving moving opportunity execution and importantly, the cash impact nafamostat the on and remain And spend. we Thank trial. NEPHRO in to through its committed

the certainly our look call please free and if Thank forward So us progress. questions, feel developments and to any sharing you to additional future contact after have we you.

Operator

concludes participation. you conference. today's very Thank Ladies your for gentlemen, this much and

now disconnect. may You

Talphera (TLPH) 13 Nov 242024 Q3 Earnings call transcript