Earnings call transcript Q2 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Second Quarter 2023 Corporate Update and Earnings Conference Call.

As a reminder, this conference is being recorded.

I will now turn the call over to your host, Corey Davis of LifeSci Advisors.

You may begin your conference.

Corey Davis

Thank you, operator. to conference second call. welcome update XXXX and earnings and everyone, TFF quarter Pharmaceuticals corporate Hello, With are Dr. on me the line this afternoon Weisman, of Harlan Officer Dr. Executive TFF Pharmaceuticals; Chief Officer. Officer; Coleman, Zamaneh and Chief Medical Chief Mikhak, Financial Kirk

that decisions patients Before we for get anticipated and treated limitation, will positive for I to necessary potential would timing and of without in in of forward-looking including, Phase about clinical effects number our this studies, milestones, opportunity regards with cash to make market the to remind the our X statements, Phase the cash studies, funding operations like contain frame moving statements call to to started, candidates, everyone X the equivalents. expected achievement our of see the time product

are cause and the of differ materially results differ SEC. Commission, and forward-looking unknown our results cause filed and Factors Securities could report Form subject with from are XXXX including may with XX-K in These of known the Exchange the that on section risks actual actual Risk Factors to our that uncertainties findings all the to U.S. described annual to statements made. statements

to Weisman. call turn my to Dr. over Harlan And it’s now, Harlan? pleasure the

Dr. Harlan Weisman

and Thank Update second joining quarter you, and thank XXXX Earnings morning, John, and us good everyone, Corporate for you for our Conference Call.

on provide outlook that over the remainder made an we’ve first the the we call, today’s progress achieve year. XXXX review going I’m and of significant On of expect for then the to half to what

clinical Officer; stage an our will on Following TFF provide Medical Chief Mikhak Zamaneh remarks, my Dr. programs. update

We’ll Q&A. open for will then up the Officer, the Kirk second our review Our for Coleman, financial Chief call results then quarter. Financial

assets, TFF’s our advancement outline by my objectives an TAC. TFF for stage that On February, TFF appointment grow our we and review expressed to XXXX. shareholder commitment of permanent early prioritizing held In call, our the our VORI corporate to strategy and value after CEO, soon clinical call we investor as

show also to respect remain long-term costs while desire that value opportunistic potential the expressed partnerships company. internal new a create with our minimizing We to to to signing also

that Zamaneh’s It’s can clinical on company. Under Zamaneh TAC. of serve our which a I’m milestones VORI call, has on development and clinical of each the been across these will success and we each progress proud months areas major considerable physician both by and rare team Based X continued awareness the as of greater of that of leadership, patient fronts. Company’s number could efforts, anticipate details help these provide moment, reaching to In progress year-end, nearly say a since TFF key build programs. I for our on a TFF catalyst key disease made of

We have reach to sufficient will also these milestones. capital

through additional an TFF capital earlier announced this financing. morning, As raised equity

in TFF to risk/reward and VORI in technology Importantly, couple lungs. attractive efficacious levels enables innovation tacrolimus delivered recognition to reduced of to that no ability while development programs. The and Considering transaction. our shareholders, this view, markets, our TFF the entities, clinical into TAC, be by risk. chemical Freezing new driven, of Film innovation opening and course, programs Thin significant to voriconazole contrast with growing directly in existing two the minimizing investors In issued close clinical of financing our to warrants our ongoing capital dilution a of the challenges were reflects my the this is

types Through to overall of Physicians interactions drug-drug toxicity but delivery. with this see systemic solutions in populations. these that compared they would and strong welcome lower delivery, efficacy, highly these improve we told to us to care improved vulnerable have expect patient

our the of stage expect delivery risk drugs, well-established ongoing By positive most to enrolling effects trials. to improving compared Phase We programs. development also X each treatment we see in first-line significantly for bears clinical program two believe of less other the FDA-approved patients

For believe seek risk. with represents optimal overall balance opportunity innovation, coupled a clinical compelling who lower this reason, investors I an of development TFF for

VORI new health, positive toxicities on Developing health have TFF that likely TFF clinical an a effective like while is patient drug impact therapies TAC to outcomes overall deliver and significant can and economics. lowering systemic efficiently

Given population, level clinical TAC each economic each the VORI of the impact opportunity. billion-plus and burden unmet product size we need, market of of $X and patient the believe a TFF disease TFF anticipated represents the on the of outcomes,

value to development the announced Film government pleased third-party technology. advancing separate quite our provide at Thin strategic remains our Freezing While quarter, of I’m remains our business three TFF objective, active. which validation pipeline primary collaborations note We of also that the during

the a we Agreement, evaluate develop Development and In using prevent hyaluronan to respiratory the NIEHS Environmental CRADA, formulations, or primary Sciences chronic with Institute Thin or the caused the and treat May, disease, we pulmonary to Program to military a May, referred National models signed next-generation dry is of biosystems to materials protective exposure Health on develop TFF and Institutes Defense respiratory hyaluronan additional part goal the of viral influenza of extension diseases as from technology managed Health signed in to formulations Protective Also vivo healthcare Freezing and/or and DARPA. to by personalized efficacy respiratory chemical and a by TFF virus COPD, contract program Projects and SARS-CoV-X, of biological Agency, commonly with will Personalized with or advance Leidos provides powder Cooperative Research under of of select funding personnel and the pharmacokinetics threats. respiratory that RSV. Advanced focus Film syncytial using National lightweight and more virus diseases. that of therapeutic obstructive Research in diseases vitro in The Biosystems protects

the a National at Business Company’s least of this of In to or Thin of of Phase using Freezing Pharmaceuticals, vaccine The Institute X part Film $X TFF announced a Infectious and million vaccine against of National agreement aim Research, symptomatic approximately awarded the develop a is to effective infection. Small is shelf-stable continue mucosal universal that to XX% with we influenza development also virus that an of Health, June, technology. influenza program Diseases, SBIR Allergy Innovation Institutes the direct grant

agreements are these external and provide source validation our by partners, for an of Importantly, funded our important technology. largely

to over call now clinical and TFF Mikhak Zamaneh? the discuss VORI to turn TFF TAC Zamaneh Dr. programs. I’d to the like

Dr. Zamaneh Mikhak

Thank you, Harlan.

Harlan trials I’m VORI. mentioned, in pleased and to As enrollment TFF to share the TFT you we’re with making X progress TAC two advance Phase considerable our of

to several clinical advance TFF months, team multiple VORI. Over by our programs. the an these has update last providing undertaken start I’ll initiatives development on

patients. immunocompromised for technology Thin lungs. with with pulmonary a fungal treatment As reminder, XX standard-of-care VORI rate is this developed Freezing Film significant is unmet to antifungal or drug voriconazole for IPA. potential pulmonary disease. the VORI from TFF including formulated invasive pulmonary using being to aspergillosis, our infection represents the is infections, of deliver been approximately TFF IPA therapy, IPA rare has aspergillosis weeks directly medical life-threatening that primarily fungal mortality lung a XX%, need a Even impacts which starting

oral toxicities high while improve but Oral into dosages therapy of and concentrations lowering treatment attaining therapeutic of the hope drug, with administration. local by directly systemic exposures commonly window, narrow the By of drug’s associated delivering significant therefore, and, drug-drug TFF IPA, voriconazole first-line systemic efficacy the lungs, VORI interactions, because is problems to administering toxicities. requires that for concentrations we efficacious cause often

our several management, We months. mentioned overall and over the with established have progress helped have for weekly last made CRO these improve considerably. accountability execution, As earlier, we CRO goals and Harlan and to weekly considerable meetings upper changes

site sites single compared I when For example, TFFs XX to joined only our a January. clinical we now activated of back in have XX first

quarter. We running expect additional sites to be this up and

the of is VORI active leading in amongst and [ph] prescreening and physicians, activities. patient to TFF is transplant pulmonologists experience referral sites networks, their The as an our acceleration turn and screening oncologists, infectious growing disease hematologists program which physicians in clinical

from As to to of has the increased study. past a the four patients result, have in four now compared XX. rate two our first months nearly in we our fivefold And prescreening enrolled X months

to amended to access VORI. we improve TFF Additionally, study have protocol patient the

the expanded ratio based often to IPA. X:X of the mortality, of improved disease In an of in unmet efficacy we participate receiving toxicity. criteria drug TFF diagnosis chances therapy investigational feedback also potential receiving improve from to have high hope a a interactions, in for our To patients with used to example, clinical this and increased with the of the which investigators, to high with allow associated on voriconazole we For drug-drug patients in for and real is choose those from trial have receiving toxicity oral first-line eligibility with study. need, VORI TFF VORI, receiving X:X

trials. that qualify options, have potential we VORI TFF developing by for exhausted some trials, we’re clinical While therapeutic for in treatment conducting not of may understand in cases participation patients clinical who IPA available the

pulmonary bronchopulmonary all chronic also an launched to have we responsive offering and invasive including aspergillosis, Program, EAP, and Patients both for tracheobronchitis aspergillosis, with aspergillus cases, Access qualified infections. such of patients pulmonary allergic aspergillosis, this VORI infections voriconazole or with bronchoanastomotic other For aspergillus Expanded program. TFF forms pulmonary

in options builds have tolerability standard-of-care on patients therapy. cases, who have efficacy, to basis. treated such VORI pulmonary with no in or treatment unfavorable were results patients with or our The program an and previously enter infections response two EAP use EAP some compassionate a had positive safety limited on The fungal who the TFF

executing the patients. in Canada, EAP for And to and pharma Australia, Durbin to U.S. able are us Expanded collaboration we countries our implement confident a for eligible Access in I’m that expanded UK will also record track to large partnership, companies. be Durbin EU. long through of has provide Programs VORI and to with access across pleased select note the help VORI to TFF the small TFF we globe this

In in that program. this enrolled patient fact, have we new first I’m note our to already pleased

see to to positive As show well-established a we a medication. therapy antifungal Harlan as effect the patients an of mentioned, to VORI receive due activity of majority voriconazole TFF treatment expect who

provide Phase rare and on X considerable tolerability and the trial. generally of of in data trial EAP disease X make in end is more enough than expected be our on may with us availability of patients with Initial the to decision clinical line no with go/no-go are Given the to what in by ongoing efficacy necessary from XXXX. we TFF customary entering historical data XX a Phase VORI voriconazole, the believe data treated indications, safety,

TAC a leads rate five-year too to largely post-transplant too mortality XX% little or malignancies. immunosuppression available infection, where the as and unmet program XX%. The for Now, immunosuppressants discussing of TAC of whereas five-year with acute leads window let an transplant Similar TFF comes recipients, the me immunosuppression is lymphoma need of in much addresses TFF transplant from area the disease program. disease narrow other chronic prevention mortality rare chronic significant in lung indication. VORI, or TFF TAC lung to in population being medical high as therapeutic to turn rejection patient another X TFF rejection, Phase developed to kidney

tacrolimus has to technology To overcome mortality TFF Film XX% using deficiencies, to formulated multiple lung inhibitor to TAC the to delivery seen the drug TFF factors these poised contributing lungs. in address deliver lung Freezing been The of the is immunosuppressant first-line directly direct transplant. to calcineurin TAC potentially five-year Thin our the

With chronic inflammation predicted efficacy would fine address The such and as of local chronic drive to fatal The suppression. systemic to the improved increases. immune be systemic exposure delivery improved systemic lung to while balance lower complications, other address in post-transplant the toxicity. lung, exposure is or malignancies. sufficient with at exposures and to concentrations TAC address the to needed the lymphoma achieved Therefore, diminished infections, minimize the systemic lower systemic disease ratio compared to acute administration, kidney of leading would potentially achieved site exposure for locally to oral rejection, to can lungs, doses lung lung exposures concentration TFF

at compared noted prevent to be should It further albeit tacrolimus exposure, of lower is suppress inflammation systemic systemic that oral to to presence predicted levels rejection.

toxicities. trial, we patients from to given active is delicate in insights have in tacrolimus risk the TAC. rejection our transition to of process transitioning at X considerable oral oral Australia Phase from transplant inhaled lung gained our TFF the and a inhaled tacrolimus The In site form

doses been from tacrolimus. outcomes clinical to have date of overall the TAC TFF match by surprised pleasantly needed We low to oral

To X study date, enrolled the active three at sites. patients our have in Phase

months. potential considered could coming expect of in database We sites a expect patients in a have patients for steady TFF we lung our transplant TAC large to additional activate that selected in the sites in our enrollment our be Australia study, flow of study. Since

data program, given VORI to sufficient rare tolerability data of general from data study, Similar to XXXX. historical clinical TFF report TFF Phase patients initial the line the expect approximately the with considerable we and end availability safety, from tacrolimus, a with of a TAC efficacy of we indications, ongoing be and what by the meaningful XX entering X the in practice on believe is treated guide Phase go/no-go X will study to decision for in and

the I’ll over second results. to review call now quarter Kirk our financial turn to

Kirk Coleman

Thanks very much, Zamaneh.

Our $X.X first manufacturing the proceeds today earlier from June comparable XXXX. clinical The our equivalents runway to expenses clinical as through the XX, expenses. for extend will ensure $X.X quarter for primarily $X.X year-over-year of of decrease cash of period of that development XXXX, XXXX is result upcoming and million cash additional and milestones million transaction quarter sufficient million. cash to we have in the $X.X announced anticipated will were were reach and and financing Research XXXX. second the a compared reduced resources

decrease the were in million patent is consulting, payroll payroll-related primarily market professional million comparable for and XXXX research, of quarter related to second million to fees the and for expenses insurance, administrative expenses, expenses. $X.X $X $X.X period compared year-over-year XXXX. and decreased and General

the for compared million million of XXXX in loss for period of of a quarter Net net XXXX. $X.X comparable to second $X the loss

noted to the our turn progress reducing for proud now were Harlan. of trial we spending clinical the been over I’m objectives. areas previously, strategic I’ll team part back of spending that we successfully call in Harlan focused not As primary responsibly the as on have programs.

Dr. Harlan Weisman

Thank Kirk. you,

has for Before in multiple of my us VORI to call dedication, opening and all progress TFF I sincere our up for like make across the hard to team to her work TFF TAC significant express and and fronts Zamaneh which their thanks questions, program. would enabled

ago, Thin transformative have disease full delivery Film commercial value has indications drug VORI programs Moreover, my by assets becoming a areas in rare potential medicines. with impact technology, months these six and of potential with restoring the of sizable to significant each populations patient rare Freezing need the efficacy continued demonstrate confidence therapeutic Since By substantial indications addresses CEO unmet the and TAC two the only medical improving our disease of two market opportunity. to in and life-saving grow. effectively in

opportunity this market, of the months If value providing will partnerships pipeline increasingly equally confident be to in in our platform, we recognized our the in succeed I’m internal the ahead. the investors and value reassess endeavor, technology company that of the with

the session. That call concludes our for formal the to question-and-answer remarks, up now and I’d open Operator? like

Operator

Please Jonathan First MKM. comes Aschoff question ROTH Instructions] [Operator from of go ahead.

Jonathan Aschoff

My first about Thank VORI. you guys, very much. is question,

And ratio the trial, what there’s you the you gives guess Given that patients sites this patients. confidence XX-patient only X:X that in meet the X to can I expectation of intended by explains year-end?

Dr. Harlan Weisman

comment progress. Zamaneh trial. while But to on further her to inertia the Officer. Zamaneh overcome your initial clinical as in Jonathan, the And it that now, process over been trial hi, and Chief up morning. seeing ramping Medical for answering good Zamaneh The has question. took we’re a went clinical remarks, that in the thank And a I’ll takes as over question. since ask is you And

Dr. Zamaneh Mikhak

the for Thanks Jonathan. Hi question.

We we have our mentioned, XX sites X level in sites of a significant progress. in XX% I have different of now made countries. Europe activated, As

are Our engaged. investigators

patients protocol to inviting the expanded criteria for who a TFF randomization opportunity more changed real-life schedule IPA. has the chance, lot such diagnosis of that X:X patients that consider Our to instead a X:X, because And eligibility receive trial of allow participation. been patients need with VORI to the is have we’ve would

us of All patients we of up initial year. the believe projecting is and to of number the to we are that end by this data setting momentum, bring have the

Jonathan Aschoff

this in me, Difficulty] I trial? the qualifying [Technical can two up patients, four to few the what’s for patients have but fivefold the only for so past tell explanation months, mean, With you

Dr. Zamaneh Mikhak

question. good is disease. That’s a a fatal IPA

a we’re the a disease, with you example, fungal is So, has is who that have one hematologic severe leukemia, for such because of, things that noticing of infection it’s top patient, severe fungal type a of leukemia, on say, now infection. This malignancy.

the is care. they clinical in So, for hospice or patients actually They’re and many up quite that we’ve fatal noticed qualify. end What why of are considered ill disease. quite who don’t trial that’s a palliative the

based is very the very for ends narrow not diagnosis they’re not might Another reason that or diagnosis they aspergillus meeting exactly criteria not up not real-life being again, protocol, as in we’ve but the that the IPA was being that participation. to IPA, criteria believe the and criteria. or which qualify And specific of improves on include that we that diagnostic capped, original expanded we study and eligibility

engaged. the right investigators of the But quite the As sure active mentioned, sites have get this we we of lot at end are study. to patients we and a the I want in day, make now

in other the you you you really do can while up think you things once I what keep thing can accomplish is -- you’re and what things to setting have up. mind accomplish accomplish And set that what

we patients as an brought of been But implement number addendum, brought lot we So, that in activating of these we’ve the been in we’ve requires amendment. steps been actually changes. in that have putting in as a sites, doing an to as we’ve putting

sites active. place every Now, they we’re where and understand impacts eligibility almost sites are criteria, and at of a are These amendment is in evaluation familiar patients. with point how the these their in approved country. The that broadened

year-end. at activities project to and to able we that we’re looking we’ll So, data the information have, be that’s on initial have comfortable the by ground the why the

Jonathan Aschoff

decision Thanks flawed such VORI allow enrollment can What for with X? patients Phase for up XX that. to come XX go/no-go you was as that about for an number a

Dr. Zamaneh Mikhak

XX-patient account not the That’s this is IPA into rare trial disease. the a did too. was of a indication The design question, original take good study really

it a of regular big do you’re for psoriasis, a pack rheumatoid study, or example, XX-patient X Phase in if disease. common, do sort big you a in doing You footprint arthritis,

because there in you sample generally, trials a diseases, patients in these trials. just size look fewer are for rare your smaller In

IPA, the diagnosis For with IP of number is XX,XXX worldwide patients. example, new of patients

So, that’s disease. a quite a rare of

one development for signals telling So have a that a efficacy, the look clinical in of and is more way smaller does disease size. you helps you sample indication rare that

the the We the drugs, also are luxury approved entities not have new. are developing drugs first-line we’re that chemical

voriconazole what profile. can their do. tolerability efficacy what know we can understand safety know So, their tacrolimus We understand profile. and We We do.

patients as think compared don’t a voriconazole. TFF able how need VORI doing is to you to oral make XX to we call So, be to

In or toxicity. to have that’s common of rate I’ll XX% give you therapy oral well our patients seen toxicity, high asthma, so because really the far in trial, a That’s had to example. had liver between the liver off healthy With with between in patients of we’ve dose liver with clinical any clinical trials, we about we’ve have very the not of voriconazole, mild patients between an eventually volunteers, patients their decrease our go compassionate use, toxicity. XX% known, very far nobody actually experience. so patients between and

going need difference to you’re the The be think patients just XX XX able enough able we make will be patients. So, to to call it don’t to make call. large this you’ll be that

an really it’s adjustment little to trial match bit better? design the a in So indication clinical

Jonathan Aschoff

Okay.

on that’s some So do, yes, patients versus you’re make to it for if you patients yes? doesn’t more gets that more think let’s that XX not do Like, clearly call, you if see XX a or will to just try a enroll to decision what make compelling, more. quite look hey, likely

Dr. Zamaneh Mikhak

look XX think was we the But be data, don’t the patients. you a it’s XX VORI. don’t then make accordingly, will need you have to that which you design, than TFF a that. getting We And would able patients we at patients lot it line voriconazole. make We’ve knowledge draw than call bottom experience oral fewer comparing is -- be oral XX always original think that’s and patients, about your decisions to TFF think XX said but Obviously, really more getting there rely that also, a need the voriconazole, we’ll with VORI you making on to need call. approximately about

Jonathan Aschoff

continue altitude, out. for I’m SG&A at R&D Kirk, sequential and the a dropping expect were you or there do that to decreases, first not you leave second Kirk a quarter. little? good cruising and which to And is the Are Okay. in

Kirk Coleman

Thank That’s Jonathan. a you. great question,

are are enough I a $X QX guidance is rate our we million is quarter, burn think through then the and us we we’ve obviously settle starting in runway got and through anticipating about into to to we giving get of -- are XXXX. that

Jonathan Aschoff

got I’ve you there easily.

much. very you Thank Okay.

Operator

ahead. comes go next Walsh The you. Please Thank Justin from JonesTrading. of question

Justin Walsh

Can you into you advancing decisions? criteria use go/no-go you to would that X expect expand your on warrants give of for it Like, results the to need asset? what your you to Phase for type see confidence

Dr. Harlan Weisman

one you the That perfect seems Zamaneh another Yes. address. to one Justin. for question. Good Thank morning, for like

Dr. Zamaneh Mikhak

Justin. Thank you,

will So, at we signals look efficacy. of

has evidence better, For certainly aspergillus example, see we XX and well. signs that patients tolerability The we improved, may least tacrolimus see for duration program, that evidence, it, example, that for the to or look of enough patients that are in they see we safety long that the TFF TFF And cleared. that see tacrolimus, to for are are safety sure but we continue signs good see symptoms as big That the and like clinical been have treatment not oral radiologic that to we there TFF VORI, want patients. transition rejection. to be and TAC may we feeling inhaled weeks. about VORI is want In as and is of some course of in shown certainly free tolerability. expect from and the to we And patients is make to to at

Justin Walsh

Got you it. trial? or of FDA the to with the And amendment did related EMA discussions the the

Dr. Zamaneh Mikhak

under review amendment, Xth the the X we’re to we out and submitted it and countries Europe, authorities it’s in various in in, approved countries, country. they’ve been the of the in made and health X We in

Justin Walsh

standard-of-care then either provide remind that But therapies What access wondering I’m had TFF that other if expanded experimental me, of of? the you or you might alternatives us patients hospice be of for some VORI. And these aware mentioned on or here. question and can face, in compassionate of terms you the just it. and last commentary Got use do angle

Dr. Zamaneh Mikhak

There for the benefit to to patients not the patients provides opportunity Program are pulmonary who from access might the chronic really therapy And that ABPA, Expanded with benefit areas, many helpful, are sensitive. have TFF who which infections. lung this for aspergillosis. bronchoanastomotic in also invasive pulmonary and not So TFF patients many get other be infections from are it. Access aspergillus but VORI just are VORI fungal who patients are indications aspergillosis, transplant, could There might voriconazole

So, a once there is you every time do another. a are you you or patients cement clinical implement design trial thing and on trial, to who protocol, have clinical qualify then have And based a particular that one don’t design. cemented,

Expanded the a of drugs. helps who systemic these able So And good patients to you who it levels not have and Access benefit it. get had from toxicities because could tolerate really Program adequate us at the or these to tried like are potentially response in therapy have are VORI they mentioned, standard-of-care TFF patients, not hands of

your at infection transplant they previously, had to we treated compassionate that recurrent when were they results. patients didn’t And were And that didn’t -- VORI question? answer that toxicities fungal TFF go, to pulmonary recipients, know good came where have for where them pulmonary the very point patients that’s use with they infections. of had significant lung to their and example, back, they The two Did was had who were given end for -- they their rope. were infections the

Justin Walsh

Yes.

Operator

Bernardino question Please comes Wainwright. go H.C. Vernon from ahead. The from next

Vernon Bernardino

the VORI been as far program very informative. have answers Your as

to the my question. I answer think I So know

X? with Phase go/no-go that will be predicted are X TFF patients make the program, the the -- also of Phase do TAC dosed enough that decision small think number Regarding the be TAC going to to trial clinical a though, you for in

Dr. Harlan Weisman

that, Why take don’t you go ahead Zamaneh? and

Dr. Zamaneh Mikhak

just think call we would to about Yes, as patients XX a make for us sufficient TFF Yes. TAC be about well.

first we’ve With transitioning it mentioned, our patients enrolled tacrolimus oral was were tacrolimus. patients. inhaled the three first from time we patient, I As to

have going low have it making we we improving of carefully, approached safety that because you’re in how TAC inhaled able to careful be dose we the mentioned, transition conservatively, were very the dose. And I that and tacrolimus very -- go patient of the slowly you So, have of balance you and about then were we have leaning been very while sure that patients making rejection watching as of to -- tolerability. surprised TFF prospects to to

those the we the second With and patient duplicate able first learnings observations. from patient, to were implemented our

call number goal obviously, bring that at you approximately XX you obviously, want should XX to But in make patients, give a we we yes, we to this learn to a information sufficient other XX of in, development that, us into -- Phase will from patients but need happening always So see be continue the your patients sufficient. additional X. also is program. be a think And approximately patients to

Vernon Bernardino

look I that to Great. forward decision.

and/or your you drugs, kind Uniphar synthesize, perhaps in TFF VORI broad example. an especially that kind see from whatever Access globally coverage provide put the Program, to the any a Expanded that with as results and however mentioned, you Now I possibility TFF Would know you Ireland want not with But Expanded the generally I TAC, voriconazole translate, program Durbin to a results might that small the together, there and patients number Access give of Program provide for VORI? of help results, particular, into be of study, especially could, or patients. is with describe you rather would -- one data -- the it guess, designed the of to of

Dr. Harlan Weisman

that and one, Why take Zamaneh don’t go you too? ahead

Dr. Zamaneh Mikhak

potential. gather add knowledge Access and Expanded information we’re through believe will We VORI Yes. Program TFF base the we that to the that going the Sure. to its about have

guide us the which to X, gathering Access by Access Expanded through It VORI next trial valuable will aspergillosis, clinical lead really is The invasive the But developing opportunity of Program trial, the We clinical Program are we and a VORI of that. in indications, conducting be gives steps are and TFF cetera. very in et the Expanded for also indications we our the to to the adds that five Phase really information TFF and us help pulmonary in. our understand the expands design is results is additional trial significant. and are clinical us,

So, that to where clinical information efficacy is are also the really be helpful we further should where pursuing signals of us understand to TFF for VORI. trials

Dr. Harlan Weisman

-- into various the have although have provide clinical Probably come that, across we collection the just Durbin. data it’s And patients up the you is sorry, program. not that do would -- with a it trial I’m protocol, brought for are to, that we that us Durban just a reasons I -- us compassionate wanted mechanism of signing we on one formal with uniformity, use mentioned

So it’s that’s want characterize collection a to if you don’t rigor, there to... the would know outcomes. planned the us allow systematic I data of and with patients but that not degree the same Zamaneh, is

Vernon Bernardino

results for Sure. make where what that small what you proof-of-concept to exactly would third perhaps advancing had know and said, do Yes. you true. additional or was sense quarter just That’s was might studies, that for. could secondarily, then, you as a for. you into if in whether generate clinic other they studies have through That’s see looking I XXXX. Terrific. what I easy My And exactly makes certainly you model looking think I just it our cash, good Kirk But a partnerships. additional opportunities think about cash, molecules provide be even is

Dr. Harlan Weisman

Yes. Thank you question. the for

based raise catalyst be data, to on And clarify, we the it will it’s inflection raise first are to think Just have expected producing from we us us clearly, going of a point next get through to to us the more money. quarter again money to enough cash allow year. to

development continue The raise is TFF TFF first to of and money business we be to the to VORI TAC. order when of fund able

on drop So, ensure ball don’t get two the that programs too those unfocused. to we and want I

we our that’s you underway forward besides out, focus. other -- are go evaluate So, that, rights and go saying have there that. original are niclosamide we’ll it with sense And as initial we it, indications and molecules. evaluate the it to makes in process pointed not idea we pipeline whether we currently with evaluating of which COVID-XX, have forward but it’s We potential But, would I’m products. to reacquired niclosamide. a recently the full and was

also even our biologics, and is flu that have agreement a But vaccines, vaccine to a -- monoclonal causes. with mRNAs we like for have develop to NIH and and variety we’re able of the universal bacterial technology large example, antibodies, shown take,

is have to we And and key opportunities. have to go should -- any be what focus to underway it’s to really that a of see through on. wealth so And for premature will with me process, get there’s certainty. which of We different evaluation The we underway we right now. degree that we have going say

Operator

The Carlson Tailwinds. Daniel comes last from question at

Daniel Carlson

a Question couple -- follow-up questions. just of

is that you submit the Program, they something FDA and on Regarding the that EMA next when can authorities, like potential to will data Access that steps? the regulatory or advising Expanded data consider

Dr. Harlan Weisman

and Yes. yes, I answer the let me We for thank of participating. morning, let you but is good Dan, Zamaneh elaborate. appreciate all first the believe question.

Dr. Zamaneh Mikhak

the as able Dan. after data will Yes. and that the part Hi, VORI Yes, we data, what data access that one is FDA be the accept to And or that part expanded valuable has do. package. of all been package submits. believe data does The TFF of helpful that

Daniel Carlson

eligibility with for means VORI, Great. Zamaneh, criteria what Can criteria. the real world you expanding you just additional on Phase that the mentioned elaborate exactly? X

Dr. Zamaneh Mikhak

Sure.

So, responds couldn’t cause VORI right TFF obviously get trial, sure the obviously, you let’s the one expect voriconazole, improvement. example, make that doesn’t to clinical need if with patients have, say aspergillus, patient you to to for because, every then which

make important sure you it’s get the So, right patients to in.

very very of that’s it criteria, strict a and IPA customarily part diagnostic the very part the is academic diagnostic protocol type valuable, which is of strict. protocol The type for is is but of that criteria, studies

For and patients as the part eligible include criteria. those symptoms of symptoms worsening And that, includes to have certain to the be don’t cough. signs be signs to and have of meeting part example, that it

voriconazole the when one and specific symptoms But mentioned they reality, considered not for grow patient wouldn’t because of world treated on cough signs lungs. That criteria. and with their is of in of respiratory with AML, that talking chest face, see fungal, for in pulmonary shows worsening fungal cough gets set IPA. with Now, about who’s hematologic has including diagnosis diagnostic physicians developed criteria, CT in now example, we’re the that be patient their that probable has cavity the the from based a malignancy, that aspergillus that real academic infection. increased a patient They productive patient worsened and symptoms, a that you have patient the

us investigators, fit we allowing like the and result -- that IPA, and about was cough judgment not. one met this to we’ve clinical of patient talking real as to to that, picture into other world after met. aspects, feedback long qualify together a the of in elements IPA various be of gave or as parameters get the get brought does one with supposed received patients with And real our world, these So, a worsening they they’re pieces story, as various of putting the bringing actually of feedback way this, that, the the the protocol, a diagnose criteria, we are

Daniel Carlson

Got Got you. you.

And will you so, that? this rate? at comment failure just about your can change can -- And you all screening

Dr. Zamaneh Mikhak

the that It should, protocol, signs world qualify should. specific entered again, didn’t study the previously, Because mentioned now, would they’ve And for algorithm, of it in qualify. real these participation. the would they into not patients some have symptoms they criteria because the and

Daniel Carlson

Got you.

Okay. And it’s again, on you one Zamaneh. then for question TAC,

clinical how match you’re TAC from what TFF your outcome that means mentioned You surprised a takes to that and that little it standpoint? from how elaborate you tacrolimus. -- Can clinical overall oral on much

Dr. Zamaneh Mikhak

Yes.

because to And these lung oral enough long or recipients. the who they’ve most tacrolimus. them months tacrolimus So tacrolimus tacrolimus control or time so, start -- lung patients oral these lung all patients to to on ago, -- do on effects their are coming They’ve recipients of been years patients toxic ago some most have -- are And six had who ago. rejection. patients more, of transplant oral transplant transplant are go are oral

shutting are tacrolimus to do I these going the this I them continue down. the to of kidneys are I with the If But patients at kidneys continue are have patient do is that on patient? the that decision whose with on, oral So, dosages the physician what faced worsen.

So rejection. Maybe its tacrolimus, I a immune decrease the to as toxicity. I but oral tacrolimus, hoping they of add have different suppressant decrease don’t own into that’s type oral I going go

now patients study. So, these the this right in types are of

perspective. we their a rejecting these from well keeping their rejection is the are kidneys They’re at as well. but functioning not tacrolimus doing lungs, their patients, patients take So, bay, not oral are rejection

transitioned So, patients. we have these

No take keep we dose We lower we’ve to slowly the of have the learned be signs and the tacrolimus there, to how to would with beneficial to transition, stable. that then no rejections, and same oral an dose levels. to equivalent effects learned of oral toxicity. go that the down TFF TAC how from how And inhaled blood continue in clinical of tacrolimus see much then clinically what TFF of patients and providing can them be tacrolimus understand benefits see TAC starting

So need need patients why to we patients. obviously, dose many more to think That’s we call, approximately will XX we very make just a encouraged. were but we final

is TAC the they we’ve we that doctors, for. is transplant the lung this when TFF talk waiting also drug with drug been say

this efficacy the patients how transition hopefully hands is and to that and enthusiasm helps there see hopefully of toxicity lot of parameter. So in drug with this improved a lower get

we we and -- of of drug toxicity change TFF be to a tacrolimus is toxicity. and be run, type them long for no assuming TAC. that There to before the type renal should the this us are develop in this the drug for that to should should oral to wait used be reason projecting see, patients response in in patients then And from they show hoping is used develop renal

the this in have be for patients from to long goal run, start. available the would our really So

Daniel Carlson

Got of you’ve turning you. That’s programs around. you, you. done these thank lot And Zamaneh, at a work exciting. Thank obviously

to that So, for I thank your want you in efforts regard.

Dr. Zamaneh Mikhak

Thank you.

Daniel Carlson

time, long short it in appears. a a brought way You

the all out that focused of just were rightly but air. or progressing Xs, So, in now? there working is the Phase anything there on the that’s of I’m on the in last question for been me, wondering if there work potential party balls just third other Harlan. number sort two past, a on I mean, you if you’ve silent

Harlan Weisman

for as be Dan, The more on we is ongoing what the that companies. big is are and emphasis changed still we pharma you, there going question. one focused done out the fish the Thank companies doing throw thing going many collaborations to to the with of have we have actually catch are. hooks fish also hole where It go in background. have and to some We fishing biotech to

value cost. the taking can the And might collaborator we the we’ve before were to want quite business that can we to real their so, taking might difference a a our were way in lead those cost, wasn’t And to make to future. lead completely business that we that -- that tremendous narrowed were be burden the on the are a where work, lot on saying, focus on is other deal one, of we -- programs that think where only burden. we that pay of the people to doing but add interests It we our we we

important to Now, wants them somebody we part to us, want that with and paying way. if it’s of demonstrating is -- collaborate for their them

have projects. And is of resource are very human course, our narrowed government of about. and of to which We’ve have we going we other excited side devoted pace those on organizations. a opportunities we group the So, more And, collaborations that on. working costs, for the we our other laboratory have exploring nondilutional that with collaborations, we’re received government

Operator

you. no Thank comments. I questions. turn will further call the closing over There for back

Dr. Harlan Weisman

in being and we Well, company. to And indication. forward as providing to And standard-of-care like all our I’d respective call. all and disease TAC November. you purchased employees our of current potential their demonstrated I’m TFF update investors programs in just rare their and and closing, in the TFF VORI to to significantly like convinced the significant I’d well today’s directors especially that’s company. I, equity again, in officers, thank corporate in belief you thank as look our the why for have who’ve advance of of Thank support another have on our

Operator

thank Ladies call this participating, for conference your your you we disconnect We and you gentlemen, that ask concludes for lines. please today. and

TFF Pharmaceuticals (TFFP) 15 Aug 232023 Q2 Earnings call transcript