TLPH - Earnings call transcript Q2 2024

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Operator

Welcome to Talphera Second Quarter 2021 Financial Results conference call. [Operator Instructions] As a reminder, this webcast is being recorded.

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

Raffi Asadorian

Thank you for joining us on the call today. our in XXXX a announced associated results we updates business press afternoon, second financial quarter and This release. This within press the found Investors section release of our can be website. and Vince Chief today Angotti, me are Executive With Officer; Dr. our Pam Palmer, Officer. Chief Founder Talphera's and Medical

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

Vincent Angotti

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

jumping the along countless with legacy. her of pioneer, physician, met medically in who decades. on and her for made pharmaceuticals mission renowned Before as a for Palmer Pam retire the coming and the this Chief Officer a congratulate care way and care to was X people is long-time of a dedicated the like October. to world as Medical patients has will improve into nearly company remark quarter, a Co-Founder decision Dr. in Dr. and entrepreneur I'd Palmer well updates the health leader for the to supervised the Pam continue setting.

Talphera been of Shakil until Dr. the FDA completed retiring, the received. may NEPHRO approval advise she be will Dr. has Palmer Aslam is of continue and potential study Niyad support While and to

the clinical work site trial academic the our busy multiple We this these her initiation the encountered be now where administrative continuing So to at to X study in the best scheduled me completed now I'm screening large to month. will report all we academic through potentially are site quarter NEPHRO study. terms including had her please sites. The retirement. agreement a have that institutions happy in we have patients in wishing institutions highest final join the be enrolling visits of with finalized X initial X conducted, and institutions, processes

While each continued is with the not once study FDA. enrolling, own expect activities, protocol upfront delays the has institution valuable designation breakthrough as had their to we interactions Niyad's our administrative do additional dictates has how in prove unique the conducted.

with and study FDA communications Our months. to study been over the coming the ongoing regarding have this the efficient, continue the we real-time we as expect progress

to: recently requested the NEPHRO FDA's of if maintain the expedite approval by of approved. we use of providers example, broad increasing For XX. We the sites maximum one, promptly sought number to access this a completion CRRT increase to Dr. to to healthcare study Niyad of inform on number study two, high-volume received and patient approval population and the institutions; a

of base already and network of identifying study. expanded the in invaluable established nephrology expertise has clinical potential in Aslam's this professional sites proven support

call, communicated Dr. As the last on

Aslam joined Development Dr. Talphera Officer as our on May new XX. Chief

clinical Aslam Dr. specializing nephrology. over experience years research XX has in of

nephrological and Nephrology assistant on focused Fresenius, and from served professor Angion, and Vice at where for renal other held years, BioCryst XX as clinical President, Diseases. an acute of chronic care kidney Hospital Development us joined disease, University transplantation, Pharmaceuticals, at Aslam He's roles Georgetown he Clinical diseases. Dr. Rare hypertension, development Amgen and and was

true our is Talphera, and and upon device clinical experience impressive Dr. and Aslam's as both organization. a across for asset academia joining and in extensive a renal conduct of expert, design industry particularly the trials drug Immediately

conducting nephro and site selected himself teams. Talphera's including personally training relationships the fostering of institutions research and initiation immersed in our activities with establishing personnel, Aslam institutional and

study activated Importantly, also completing assessed coming and combined the a high, which enrolling with study hours we're time the after of sites. in the the XX principal And efficiently sites largest and patient study investigators a clotting be relatively of should time our time timelines, not population study completion sites, patient secondary of efficient hours, XX only support we should study clotting while that XXX remains is enrollment the our study PMA the once at sites filing study is Recall endpoint. with the is to ready of expected expansion and balance XX guidance will measured with the weeks. over completion on our engagement at including the prepared These activated endpoint short potentially X underway. enroll to primary patients now provide points, fully believe

an for expect We timeline next our call. to quarterly and provide completion, on PMA filing, approval anticipated updated study PMA

the launch included While has This the the again, on for research of clinical commercial profile nephrologists, in study commercial to strong pharmacy approved. years, contraindications is been and citrate. ongoing, further heparin participants The preparation if activities patients and the safety nafamostat's intensivists, we've prelaunch impairment group XX-plus for particularly of research over or last highlighted Niyad group for directors. in our with working market liver

half-life, circulating nafamostat's with citrate. be and such the unwanted avoiding longer such participants to cleared attributes agents safety the potentially it heparin as as rapidly ultra-short Specifically, allowing commented and seen complications on its

outpatient approximate this We for opportunity another opportunity of million our peak that uptake compared calcium cost our anticoagulation, study and the research levels. to being cost addition, as competitive includes the potential settings $XXX conducted. citrate while required total a In million, of dialysis remain of could peak current add setting the a to NEPHRO results is the monitoring calcium in in the on our price sales. the hospital least is the sales hospital of reinforce at which support belief $XXX Niyad continues CRRT where estimate focused commercial of at These Niyad as potential

continue efforts GMP-grade for ingredient and commercial CMC stability related on active manufacturing the All to shelf-life data date to finished In in product. for potential production support our specifications. product drug clinical extended We're Niyad. progressing met to we collecting our our to positive and addition our and commercial have advancements preparation, study make

manufacturing over excellent the cost specifications, Nantahala remains handing to and Our ensuring continued to achieving Raffi, have know them. for the with to adequate call in the job parties continued study, the And largest financing, and we to before timelines, Talphera's clinical highly PMA which result was amend our the expectations funding it's potential Niyad. This of of investor, the on partners done and an our set of important as committed of both that September to supportive second expected the reach close occur extension originally year. by support appreciated, of timeline, approval the agree need original of planned to this timing XX a progress is

hand over Raff? call results. I'll financial to Now Raffi take to you the second-quarter our the through of details

Raffi Asadorian

Vince. Thanks,

facilitate expenses $XX We second while close and PMA. that will the million in on investments. has investments emphasis helped This prioritizing timely to our quarter us control of continue operating Niyad with cash the filing expense containment

million of Our operating second excluding $X combined totaled expenses, cash million to compensation or compared expenses million quarter R&D year. $X.X last $X.X SG&A non-cash the in and stock-based

quarter, related reduced operating to expenses million we While of has previous $XX remaining to million year the study the accelerates. The CRRT the million the been in to enrollment as from we of certain $XX NEPHRO for year quarters the expenses cash million second $XX for will expect of increase estimated $XX to incurred these the costs study range accordingly. range

the we achieving our financing January trial pivotal earlier, that upon September of the mentioned planned by XXXX As second plan on was of this XX contingent date the amending closing year. from milestone

before completed I'll filing XX-Q. amendment now back We to our be expect Vince. next the this call turn to quarter

Vincent Angotti

have. open Raffi. now for lineup any Leeway? Thanks, I'd like the you questions to might

Operator

question-and-answer [Operator comes will from Wainwright. Instructions] And and begin line now gentlemen, And the Ed question our Arce session. of the ladies we of H.C. first

Antonio Arce

add questions. I to just first, covering my congratulations Pam. very company have But with wanted congratulations the now, been and since years well-deserved I've to very XX hearty worked to couple beginning, the a offer for a to my I retirement. of Pam wanted

Pamela Palmer

Thanks.

Antonio Arce

update. the have I the up or been to call to study? go to So if of that date the are it's into a terms that the the perhaps we number for next wanted completed have get sense timeline now, study possible, screened in But patients I coming and/or of where patients know for in

Vincent Angotti

weeks So the characteristics potential. to And screening, relates primarily quality particular enrollment maybe would these potential and sites, lower the as lower done patients several by you screening are sites. what at you at nature, particular, the in you patients enrolling call enrolling particular it because were and of institutions. of at their diversity the I'll which lower them makes the These last at have why Palmer, might SiteVault, on at selected of quality has sites begun sites, the comment a can care within of Dr. sites. say, the just these the the these of PI potential

Pamela Palmer

happen just older patients, sites, failure, ICUs, be in adults patients safety versus patients, to quickly. sort and need a these got surgical mean the ones ICU, medical broad spectrum up particular running efficacy liver I and that yes, see more adults. of to a younger But Niyad's with younger They we ICU, of different

lot for from than expecting And we're get in to X They the and quickly sites but so that these others, running a the reason. mix more were happen patients put up just them. not of

site that and prescreening -- we've not to up is and screening, started screening have considered they though gotten big even a recently they're be more So heavy hitter. much running

Vincent Angotti

study, that, X the screening mentioned, course importantly, point to screening X.X has the think came on and to day third think the weeks one your of, just that no I it started while Dr. become I first site the it's over last after up enrollment-ready patients. -- Palmer weeks, completed the

really highly close the their and is they month then go initiation they excited of the this of And see all by enrollment immediately cadence should on versus enrolling got this the visits screening we'll site are our ready the as they highest about complete on to And So sites month. ramp the completions. balance the all and study. PI as start in scheduled the sites involved the be and

Antonio Arce

are I for these Raffi. for Two may, others, if

question one I remarks if enrolling that operating in mentioned missed could was Phase any and the the for refinance -- about your X. an year, sort then to other around exactly financing of with be the Wondering as And I you would on plans happening the that what you the there color what's costs prepared expect would cost September to your you such and of that. think there's said and expected as quantitative increase remainder OpEx? provide

Raffi Asadorian

year, operating new for million. expenses -- reduced has the is to Ed, reduced million the to been this we $XX guidance, $XX for So cash

year-to-date. take million if about So $X we you had that $XX million,

around can cash for close million for expect operating half the So expenses second we $XX that given the of range.

the -- for for million of from bit in each $X $X expenses a quarter, operating we've got the increases previous QX. about about million it for So $X cash million QX,

So I expect increase. that to

evenly completion If already the to the discussions, in works date date. you some the for amendment, get both the And terms study Nantahala kind date will don't what $XX forecast And of discussions forecast on I pivotal date half to and but announcement that that focus to in really here we've priority. for on is with work year. amending million that's but that that second first the that pretty new as parties to a Nantahala, be, to that milestone. the that want of mean September I the terms real done remaining to amending of of initial trial that get our focus the had XX

Vincent Angotti

with a of make representative the a just to is just team quickly. Board, Nantahala and how on management you, being I and in comment conducted the Jain active pace. then remind the Abi Nantahala they're I'll to our on know wanted highly is on they're study

good very very helpful have there's to which with alignment So been them. has

Operator

Nasraman question comes next Maxim of Group. your line And of from the

Unknown Analyst

also have want Dr. congratulations if well-earned my retirement. her her extend I and I to on a I couple may. First, Palmer to questions, just work of

additional in site Do to the of gives happened what considering XX. you're sites initiate prior you think timely sites? and you by you confidence that how And could that the the expanding What do you can think that mentioned you an end sites? of would number long study it a XXXX, how initiate take new you get manner? additional done to So to

Vincent Angotti

going it things, of then over Dr. to couple I'm Palmer. to turn a And

we by why to ready X the with be So I while now the did of important that FDA. we've understand it's prepared And close that to got think are we sites feel enrollment the been this month. sourcing in that sites get sites, I'll And original always the enrolling enrolling to again, potentially the up to emphasize XX. sites highest group We've highest August. occurring within

more And course, you than of sites source so many that.

is process the we've the with facilitation the administrative way of think key of is quality in element contracting learned sites I combination the and the moving process what the that forward. along

you the that we and So that might the can Dr. apply believe that we've what next maybe comment to sites. going we're of certainly Palmer, set the of not them first they affect enrollment. do expect date by learned all won't to enrolling have we affect to And And end year. patient of how I half up the enrollment, second half the of to likely XXX them the

Pamela Palmer

only we're focused this mean, on set Yes, different centers. really academic CRRT the an around is I our be were truly that able volume that, is just of patients, an insurance these insurance type evaluating feasibility critical CRRT the sites not the to policy, will quickly half. of last on And going get patients that site be of questionnaires policy of half focusing at for be board so but a ability and the That than to to absolutely on the them give budget. and faster us lot to first contract enrollment rapid new

Unknown Analyst

Just context the or additional color around sites? I or that point, high the closer enrollment enrollment give lower client sites? to, to like sites you these they of Are closer the more guess, on just could scale

Pamela Palmer

their but to also higher, volume be ability that just processing CRRT and really we're the universities, paperwork that. for enroll, sites rapid definitely it's it's but No, streamline going selecting their can not â€“ going to

Vincent Angotti

sites. our initial started already with additional an XX We've contact

it funnel manner not. respond quickly we're expedited an the going the And to ultimate assessment contracting fairly can fairly again, large be know get they to the to is pretty number. down XX out quickly So or facilitated process early in and where

Operator

our from And the James comes question line Global Molloy of Alliance Partners. next of

James Molloy

-- walk a little bit you is through Could Dr.

near coming get to the think yet? And to highlighted being that on call? What the that love on sites one's X thing sites. the of the mean hopefully, since the get term. I'd on thoughts sort then were going, I changes in Aslam's his instituted this enrolled in enrolling highest no you been does

Vincent Angotti

So on the comment I part. can last

the then these visits total final site highest August, sites, they'll a of X so be sites, The sites. X they so they'll month, occurring are ready meaning Of close. enrollment it's enrolling this are So the final be initiation ready. by enrollment

of August. goal by is close Our the

The nowâ€¦ that are first initial sites

James Molloy

it. enrolled a think enrolling anybody. in What mean to sites mean do does you it highest mean the What in enrolling enrolling? I don't trial Do that highest on pick highest hasn't sites? you you'll be

Vincent Angotti

Well, these are the non-specialty sites.

X sites the that mentioned is So balance where patient these patients volumes unlike the study. as to study and the parameters order X within much the going specialty based that the off to maybe younger out lower. be where be surgery, initial in based on be those they screening criteria. Also be have of the process feasibility sites, X The are that much we volumes off fits focused filled in of earlier, included are And cardiothoracic higher just screening original in the pure are the lower. of sites both can population flow that maybe they enrollment patient our will the

So that's them of assessment according our them. and to

Beyond that, modifications might Jim, what Dr. been question, some changes I your are of think occurred was have or since the that

Aslam company. has joined the

Pamela Palmer

on not the is call. He

Vincent Angotti

call. Yes, the and on he's not

Pamela Palmer

world. really, he's folks he knows a time. specialist. these not extensively from a yes, this on an folks. CRRT is of in But pain call nephrologist, the He knows lot I'm this area. knows and of He comes He's this anesthesiologist some

pushing on sites handholding the to this them we these getting really them part more enrollment and so getting and budgeting of things. get through that he's a just urging can phase fun lot and contracting So of --

his of and a field. So this part is in relationships and just that's critical just knowledge deep this

Vincent Angotti

the though. answer on just yet. enrolling coming the answer the of question. that sure to answering question highest part month. this your started at of that close that did -- That's question make make enrolling we in screening first Jim, Is your we're of that because terms highest sure We'll haven't

James Molloy

highest name the enrolling an them. for aspirational guess I Yes. of sort

start rolling you highest will enrolling. it once think be I the

Vincent Angotti

give would the I'll feel idea on times, can I particular ability XXX% call study. low an enrolling Well, be. what the These institutions have sites they feasibility you the based

Pamela Palmer

again, Yes, study, questionnaires to sites out feasibility questionnaire. the per all many of a are mean the had enrolling low ones up protocol? first. of and the patients criteria CRRT unlucky fill these there's little exclusion that knew site the that ahead and into would bit time, ones to at be week beginning would I their already Yes. that a the seeing knew were how that that asked got we you be happened fit X inclusion we the that sites just just running we So

Vincent Angotti

is to our on Jim. institution. guess, started we their questionnaires process get and not this it's So sent feedback an us that when we the them based This to with

Raffi Asadorian

they patients population X X as you the is of ready unique could have facility. to be X. Dr. these screen. in more patient these, sites particular PI, and streaming data their influence the some I a involvement or if think mentioned And And smaller domestic again, this, is [indiscernible] some they because of an to in it's even thought ask. these might important That's and Palmer diversity were It's fact X, that leaders enrolling with that also in of the again, first that you the the I and think potentially up X, lower important, someone would the that might PIs, set. guidelines why they of particular, that interesting It why the are with include quality though the would Jim, that you the [indiscernible] their international sites? I guidelines, of they you was investor key of give

Operator

to to closing over I it at questions no Angotti are like there further Vincent would time. turn remarks. this And for

Vincent Angotti

make Thank their any on remain And who contact today forward execution focused free our to thanks you, future and us healthcare if us for patients, and look you feel developments. available We of study and and to providers controlling if again, spend questions, to your sharing through all support. our to joining we the again, driving Leeway. to have of approved. the value additional are absolutely and the continued Please Niyad call after you NEPHRO shareholder

We have high Thank moving forward. you. expectations

Operator

you Thank and conference Thank This participation. your gentlemen. you, ladies call. today's concludes for

Have disconnect. now may You day. a good

Talphera (TLPH) 14 Aug 242024 Q2 Earnings call transcript