TFFP - Earnings call 3 2023 | TFF Pharmaceuticals, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Third 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. Hello, everyone, and welcome to TFF Pharmaceuticals Third Quarter 2023 Corporate Update and Earnings Conference Call. line are the on me this Dr. afternoon With of Dr. Weisman, Chief Pharmaceuticals; Officer Executive Harlan TFF to Chief of Officer; to positive to Mikhak, including, timeframe regards are market and of get II the this Zamaneh from in achievement results to operations Medical decisions Phase will effects without Phase started, product risks treated Officer.Before Chief call the our the make milestones, the made. studies, I forward-looking subject in statements we to cash limitation, studies, moving opportunity Financial unknown actual and to of statements our candidates and III would necessary anticipated forward-looking clinical differ see like contain remind statements with known patients about equivalents.These that cash and and for uncertainties everyone materially number our to statements, Kirk timing cause for that Coleman, the expected funding potential the may actual are results Factors that to U.S. all could described of findings the differ cause with our in Exchange the turn report the Risk annual of XXXX filed our XX-K to Form on it's including and over Dr. call my pleasure SEC.Now Commission, the Factors to section Securities with Weisman. Harlan Harlan? ahead, Go

Harlan Weisman

clinical for TFF Freezing TAC. by Corey, conference a will corporate expect major I'd afternoon, these success our from discussing data areas and you, ongoing initial to we of studies catalyst believe Phase our data by on our safety that from joining across Film made and Phase defines evidence we of can VORI progress results key are Based company both of strongest in In programs. the quarter as we've and how of and today's improve time studies we for on call clinical rare number Last spend subsequent everyone, Thank II readouts, drug a detailed third year-end.Assuming in us the disease accomplishments quarter, update X of date thank populations. Thin data initial to TFF like to good continue progress, serve II TFF how our call. you these patient for anticipation these efficacy for earnings and trials XXXX both and providing the positive, most considerable

We will Dr. time relevance lead these within their reviewing will what Medical in spend will, presented Zamaneh Chief X and Mikhak, Officer, therefore, a context be disease endpoints the indications.Our this clinical rare moment. discussion of

a the TAC advancing longer-term data quarter of positive for $X.X Kirk Zamaneh, continue the providing we the third clinical sufficient note funding TFF our programs. over capital into Zamaneh? the Following company's call these we voting Zamaneh, contains TFF the her us million programs data that our stock a capital X in studies, equity increase the executing financing, now then open TFF authorization reverse prioritizing to that allocate registration-enabling manage we both compliance request board I initial II our several initiatives ensure statement significantly split our items remarks, expenses are that over to request listing closed to Q&A.Before as implement proxy for upcoming it's turn while the end, preview XXXX.Anticipating I'll continue extending items.With into Financial In these data planning to these who we a VORI We runway resources. and results. for critical corporate readouts and to and voting TFF X review to our to XXXX remain reach with should fundraising how to like including we call efforts quarter with Officer, and over to would studies. turning our a our closely hope the Coleman, our We'll review could VORI requirements. Chief X of that we think briefly NASDAQ for up will important our have readouts efforts your future programs To about for months, facilitate support TAC X will determine strategy the August, Phase stock necessary.Respectively, our call that, and second that from next

Zamaneh Mikhak

you, Harlan. Thank

the Harlan TFF As year-end clinical and VORI relevance, of endpoints, we success.I'll mentioned, the definition TAC the focusing share you of to Phase TFF start data to with by review II I'm and VORI. the pleased type with for initial studies, plan on TFF their

is infection Let's primarily IPA. potential begin pulmonary as VORI invasive for IPA for first-line VORI. starting proposition with hematologic that the aspergillosis, fungal organ patients TFF TFF medical lung value or pulmonary immunocompromised with including with a a with is pulmonary the treatment stem developed and solid being life-threatening as such cell who patients, malignancies receive aspergillosis, is affects therapy need patients unmet or fungal or individuals for transplantation.Voriconazole IPA. infections,

treatment patients high visual are interactions photosensitivity.Drug-drug limitation these high globally drugs chemotherapeutic orally a the in based positive Film illness, efficacy Freezing efficacy a while with of acceptable poor administered of with the VORI rashes. and systemic as basis. we Other toxicities interactions. and safety Phase immunosuppressive X represents toxicities approximately which clearly was drive believe tolerability decision and to to are a aspergillosis, needed address with systemic other Patients and compassionate patient's voriconazole of approximately of The and have Phase for to invasive into represent XX voriconazole. when another disease. volunteers XX by rate for XX associated results were medical that no represents and IPA and we which with doses common the also and of opportunity a healthy upon TFF discontinuation the oral arrhythmias, XX-week asthmatics voriconazole.Results and, day Ia milligrams localized intravenous rates need delivering from X thus, its patient's antifungal serious drugs Both minimizing levels voriconazole significant and drug-drug VORI.Thin IPA where decrease had favorable. patients reported disturbances, voriconazole significant a opportunity a recurrent oral of underlying drug-drug for intravenous patients up and delivery, resides. QT increase standard-of-care driving exposure Phase this or technology significant toxicities therapies. prognosis. history advance unmet interactions study rates liver of associated with voriconazole the pulmonary compassionate interactions.Our is hope sub-therapeutic The agents, lungs use the demonstrated Through drug-drug on into TFF of directly or toxic with studies prolongation, available patients fungal to were II enables levels, us Ib study a lead toxicities Voriconazole infections surprisingly, rare Phase well-tolerated treated results the with commonly XX%, in a signs for to mortality this toxicities use include from XXX,XXX such to and potential systemic the the mild intravenously, and I can toxicity, or in infections fungal most showed infection However, with pulmonary toxicities twice toxicity resulting or respectively.Not testing There

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VORI II proven study radiologic, was no the evaluating Phase the as voriconazole. use trial Treatment endpoints ongoing both as the on oral compassionate cases, interactions the Phase drug-drug The a in TFF well no spora mycologic the patients, is responses, Phase need open-label fetus patient, probable or patient. X studies II in diagnosis results events were IPA. study I treatment and the XX TFF In for hospitalization. clinical, X Europe. tolerability, all-cause with other The randomized, weeks, there include reported.Based and VORI mortality.Before a no of favorable adverse and establish to initiated entering trial in are resulted in period, Aspergillus screened treatment duration patients and and safety XX-week is was versus the of from

them the that bloodstream.We which infection lung inhale on pain, enter break the shortness record and and severity. the breath, spirometry, much through by how like caused to the its gain by the wall culture, a caused cell the and by off infection confirm immunocompromised of microscope, of up function coughing aspergillus is patient is impact patient's can piece a the with by air their test document vulnerable screening is we how fast. infections chest or the and condition fungal During or can process, patient's underlying them IPA.We understanding and or an the renders indeed makes by the infection signs of of and fever, growing or which that symptoms detecting such visualizing of as aspergillus exhale galactomannan, examine under the aspergillus, DNA, detecting it of that in blood, aspergillus, We

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is drug-drug or of as function et spots our intravenous clinical will a Our Chest size as measures defined of be rare considerable we in efficacy will disease signs defined treatment define select to a symptoms provide Access treatment open VORI? be share such or spring, clinical II historical expect in XX treatment, abnormal evidence a of we of for VORI quarter U.K. and voriconazole, We submitted The data will the improvement data of the weeks such how nodules cetera.So of A last in evidence approximately or oral III example, first-line calcineurin and evidence majority patients a treatment assays and/or assessment and our anticipate is infections.Given voriconazole trial in need XX safety U.S., success and and like the and findings radiologic in and more tolerability improvement the fungal after response end unmet decreased guide safety, data subset by was of patients A set include address an in A TAC year-end prevention by aspergillus in the Together, performed TFF to toxicities of be and will transplant a inhibitor the mycologic defined from Canada, galactomannan. to FDA Phase non-detectable Tacrolimus TFF with commonly XX the lung for be mycologic, Australia, a with response of the response of XXXX. rejection from decrease for program. number countries. developed compared year-end by Phase II potential Phase data go/no-go to define response patients.Now post will meaningful data response. EAP EAP do in on of will rejection. line and discuss TFF no overall the transplant. and/or is initial in U.S. we or way for CT indication, to this the late FEVX. the of radiologic pulmonary VORI or our these amount sufficient interactions Expanded Protocol with of new data plan I'd now by We with By significant being lung for as success historical in decrease TFF complete background, the TAC cavities, seen indicated a TFF first as decision.

approximately well-known biomarker due preclinical there to bronchoscopy is transplanted form kidney not the TFF to of or safety is of used to the been which the Phase rejection acceptable lung during TAC oral the leads as dysfunction drive receiving baseline too and make patients optional upon period TFF to injury to collect acute into to lung performed limiting an study documented addresses intravenous immune However, patients tacrolimus designed as tacrolimus stress rate repeated an who donor-derived to several through to immune transplant single-arm site is chronic CLAD, improve doses to of A are A which acute Patients trial TFF to profile XX% tacrolimus lung, in such unmet is an treatment transplanted exposures XX,XXX X to measure locally ongoing Phase demonstrated index. receiving an standard function TAC safety concentrations lung directly organ have allograft lung X suppression the taken with serves kidney lung therapeutic tolerability I has Too subjects, or the B immune baseline of lung bronchoscopy look and to chronic tacrolimus preclinical high lung an in X.X expected and of daily approximately to pharmacokinetic systemic dosing patients data reduced to treatment, cell-free mortality to high which analysis advance suppression little toxicity. a efficacy toxicitiesSimilar measurements. parts. a due rejection, the of much significant while to a in transplant X-year deliver the systemic have TFF and and through need. genomics of for disease, signs associated blood II X-week TAC oral and supported transplant levels leads systemic to into go to generally are strong chronic sample potential rejection.Spirometries drug levels and to up care.Similar well TAC infections, and the TFF XX-week suppression decision testing tacrolimus.Our II to function. against open-label leading narrow malignancies. and I Prior were medical favorable our the Thin kidney infection. a inhaled the introduce a drawn of Baseline was blood in for data, therapy in VORI, VORI, screening study biopsy non-invasive is relative distribution to toxicities The designed patient's due tolerated.Our a DNA, Part patients whereas globally, sure performed Phase single showing Freezing to which expansion in Blood milligrams significant to a a of dose formulations.TFF TFF or post-transplant with healthy current is Film oral inflammation Phase TAC require the do by represents study opportunity differentiated of is lung attractive demonstrated compared a milligrams There period. period assess rejection. in Part using

relative and TAC. spirometry oral of tacrolimus. levels screening Clinicians reassessed, avoid expected dose then tacrolimus measured monitor TFF achieve X/X including tacrolimus to lung TFF this the is blood into We the at performed same data endpoints phase expect efficacy for completed, of III a patient's including signs TAC achieve infection, and circulation. complete donor-derived oral is TAC adjust and success biopsy we through share again, delivers believe transplanted are first levels subset of go/no-go by These tacrolimus cell-free trial's are the year-end to us a we and these enough XX-week Once low end damage to that reduced lung toxicities.Following approximately then the on from look to kidney enter or expansion.Similar stage? XXXX.So concentration blood rejection. assessment patients to to the stress Because bronchoscopy quarter with genomics needed open Phase the analysis, study, define label patients period, the period for data Finally, rate of but entered blood We initial to given levels. for throughout creatinine help set clinical historical rejection, option infiltration TFF and lungs, significant there screening a information from as during and of stopped, the decision. to Safety of levels approximately patients a lung. amount safety determine will data the directly treatment tolerability tacrolimus. tacrolimus be by DNA exists X/X are levels a the glomerular that oral the Patients tacrolimus imaging patient enough to to the the for chronic TFF patients a is from treatment oral sufficient functions be assessed of blood are to TAC more high systemic data function, for in higher XX and are plan lung therefore for and to of injury the do voriconazole, how

presentation of the absence DNA donor-derived creatinine rate or to function.That glomerular obtained potential and to that tacrolimus kidney immune TFF the for tacrolimus is to these at TFF define expect biopsy diminished lung exposures tacrolimus on the the well mentioned, Blood patient's our cost levels, for and be X/X at function.As to lower to blood the provide from signs lower at filtration Lung tacrolimus at systemic quarter and toxicities.We injury are stabilizing assessed of and to biopsy oral our transplanted be result, analysis TAC upcoming now understand prevent Kirk prevent look of as VORI sufficient as will function patients success other over inform we the presence programs. and for stress TAC TFF will ability of third a to blood achieve data rejection. systemic sample that suppression As oral cell-free call the of to assessed turn to be as concludes readouts end transition blood period. Genomic rejection review levels I'll the bronchoscopy approximately levels will and results. on rejection. repeated of X/Xs while kidney will rejection Kirk? my financial treatment

Kirk Coleman

much, very you Thank Zamaneh.

million on cash million of transaction proceeds based cash closed Our XXXX equivalents gross on September and received XX. XX, $X.X the were financing $X.X from that as August of

We turn ensure and to quarter operations our expected the current on are monitor runway our resources mindful expenses spending patent in is of compared the decreased million insurance, expenses, is for primarily to expenses of net The year-over-year in $X.X professional and for were to XXXX decrease only net $X for of third to the to now XXXX of call third XXXX. we comparable and core XXXX.And clinical $X.X administrative development quarter capital of activities.Research XXXX. quarter back the cash for decrease market period were compared second consulting, million fund continue research, primarily remain period XXXX $X.X payroll of and to expenses reduced the and Our quarter a fees, of over the $X result expenses. related to third of in The compared for into to million manufacturing XXXX. I'll $X.X the for million million year-over-year is $X.X comparable million related The loss the $X.X million a our loss comparable million Harlan. period expenses.General

Harlan Weisman

has the these of diseases. call bring with today's value a Phase hope provided VORI are we most I to TAC X endpoints, II TFF designs, to our Kirk. TFF trial and clear hope you, and clinical from importantly, rare with you Thank patients who suffering understanding

and TFF to TAC relative and these technology, concludes look would like Generating the updating I further you Operator? risk think standard entities, our remarks, validate the we for Phase formal historical associated open once assets, the mentioning for I'd reduced new significantly and rest improvements pipeline care.I support and to with the the TFF involving available our significant programs current will that worth again the it's molecules. year.That TFF over our programs given shareholders development continued our thank progress also TFF of up TAC and and your positive well-established like our for to question-and-answer demonstrate now Pharmaceuticals, throughout on we in confidence how the TFF studies of to our clinical forward VORI the data believe is chemical session. represent call II in lead VORI results

Operator

Your from first Jonathan ROTH. question is Aschoff from

Jonathan Aschoff

second I what know but how giving and qualitatively has between now can or precise any improved you enrollment not that you're say quarter enrollment specifically about enrollment for call, VORI? update,

Harlan Weisman

over that Zamaneh. turn I'll to

Zamaneh Mikhak

through drug the safety also a of our protocol in of generally we're our nurses, have them much and the effectively. have X:X pretty II in XX% what match clinical now, rate now we trial.To and to to complete fully XXXX. the you the patients. the us and our is to then trained study, And in Phase sites XXXX, need very sites for track broaden significantly. very IPA right to hospitals measuring have enrollment pharmacists, XX% access by first of as conduct is, because to are increased active change prescreening, We and investigators, by to sub-investigators, enroll on dosing that participating trial. at have And has to to QX the for all data We have rate a need see prescreening of and the to active available And the these to randomization VORI activating clinical eligibility efforts enrollment that, amending this ratio equipment data a on-site sites that, to our that's result half study trial of of through initial actively you of more parameters. TFF the clinical that spent increase point coordinators, active trial, clinical then we from there have have and year-end communicate of end the X:X set sites, then efficacy And you are with you

Jonathan Aschoff

of II expect the program, your III numbers? for is enrollment might we What say, size Phase Phase about what

Zamaneh Mikhak

In terms enrollment rate? of

Jonathan Aschoff

trial. Enrollment of numbers, the size

Zamaneh Mikhak

working in III is that Phase if rate be, mortality mortality see. enrollment the because expect for feedback especially of that ultimately, I finalize And for study, trials III, you type the matter expect III. will any enrollment of And time trial that is we generally the III case type and would total more of something Phase general what size we to had data you can Phase faster need any finalize in have size that be, in the sample participating.So than we of FDA higher before part general, the in or are FDA to we number the II. That's patients terms trial, of the generally patients and is all-cause plan. this No size generally with the what would The our we to have of allow what still But of really we after particular speaking, be enrollment a Phase we've clinical by you interaction. the are enrollment the investigators that rates for with and study. doing helps sicker endpoints this Phase are into have on.

Jonathan Aschoff

Okay.

no-go able a FDA So you decision, meet sufficient Phase patients for XX your said XX of Phase III or also program to be and meeting with is that's XX go patients III -- Phase designed? get II have patients for their something the enough an but end to is sign-off does

Zamaneh Mikhak

that I Harlan, take one. Sure.

Harlan Weisman

Yes, please.

Zamaneh Mikhak

with X patients indications. entity. for chemical safety, anticipate or data us great new and to these a that that active ingredients not -- a from know FDA for sufficient we matter. effect.And voriconazole the rare and There also, really efficacy feedback drugs, data with tacrolimus active is about approximately rare questions the deal of be hold that is tolerability desires to are pharmacodynamic and our design. concept We know we in go we're a thoughts So III XX We meeting voriconazole will to to back on present trial Phase the get

plan the possible, such get informative as come possible a as and of from for will as FDA with often we the as believe and interact we indication. III because feedback. to that's it us that the allow will early XX we and to do to design So, data quite patients Phase optimized that, that be efficient And

Jonathan Aschoff

Okay.

differ? you're this to different going same parameters those on of the to are difference parameters? with be going are going year-end to think So don't data, first patients? for saying going is you the for data What's TAC. have be for quarter, is releases? 'XX you the I How patients Or data more amount more data Is in time number that to XQ in particular. X releases that said same in VORI 'XX the some about X those this 'XX of X

Zamaneh Mikhak

Sure. Sure. It's a combination.

have by and year-end on to we present have. patients We of all the expect data a data subset

X finished some XX So, have treatment weeks and of finished treatment. patients and will have finished will and X weeks some finished will the weeks X some patients some have weeks have of will

that So we patients approximately XXXX. we complete more the effect then discussed of a have we of will first the by on present all the end have patients, data quarter XX parameters and data will that with subset the and we

Jonathan Aschoff

Okay.

So the that but end likely, first you that not, quarter. end more patients than XX accurate? have 'XX by -- them by of Is year, it's of won't likely the this have highly you'll

Zamaneh Mikhak

exactly is correct. That

Operator

Your next question is from Justin Walsh from JonesTrading.

Justin Walsh

guess, for. mentioned, the are or what you respect looking related on. other safety meeting to don't events a be should specific sense efficacy formulation very end and know but they that people to that with known, I the concerns II with maybe inhalable level overall thinking the the get there's they'll and something about just of of I'm so looking both of maybe either if a, of well what for, forms couple information adverse trying voriconazole out want they expectations potential would Like more that FDA. release your Phase be profile, with data to an I have might and FDA know be the tacrolimus to

be So would any that helpful. more details on

Harlan Weisman

Zamaneh, and that that Justin, you're positioned best seems that. to again, answer

Zamaneh Mikhak

Rashes very Visual symptoms getting common of point, voriconazole. is stop too patients. This has reason there been quite X, for for With X certainly Sure. discontinuing and oral oral certain X a some treatment. voriconazole times have uncomfortable, they adverse at go and the whether physicians and signs function to are are reasons intravenous tolerability, common. intravenous for are up of very voriconazole. respect top are upper that limit or their hepatic hepatic normal, common tests safety patient or you Liver is events discontinuing and toxicity. decide disturbances when use very uncomfortable toxicity. X, There It's

symptoms be certainly or way, and these uncontrollable certainly historical inhaled you of sort, common for look evidence we with signs data of So any we expect upcoming what the or data.With those therapy, for bronchospasm of and inhaled on happen events also with to compared and what type on events a those, and types types in the adverse of we therapy, have. of the of in release.We report we certainly all report adverse to or cough certainly might might looking we those, to respect are comparative report with will things following follow plan and

tolerability, what varying way patients safety, informative. informative We that in of be was share in the that the compassionate I amounts both report originally and same have present patients X available use to by in directionally of we for of subset we will We very treated the will of and and times. It will as mentioned, that's this be been efficacy. presented will the us data believe end that, patients, year terms a

will So we'll share the that of of we then quarter form that XXXX. the expect that or by first complete the end the set more base data data

Justin Walsh

on of rightly of for more X the VORI and applications but big things that on TFF highlight? me. be guys just that so, about, provide has commentary TAC, some Thin a other and that been doing you focus might work to Film Freezing maybe the excited been just And possible maybe have quick some you'd on, TFF you other like Obviously,

Harlan Weisman

molecules.As the we're deliver and take our result collaborations potential one. spray VORI I'll antibody meaningful in dry and and nasal But, to to monoclonal all small early emphasize biologics, has of we too RNAs, our of process a other dry to a continuing the so the using say pharma to as opportunity last Aptar an Unidose for Well, potential system. of view whether that Justin, example, into it's of posterior powder aerosolizable used in TFF TFF the that utility Aptar any powder that the and where them into tremendous with TFF as TAC. we of it's announced cavity to we could business we collaborations convert vaccines, like important of able company, the nasal upside as will publication an the these monoclonal formulations Yes, results collaboration a creating technology with Pharma, variety we've been well demonstrate the biotech molecules, antibodies, companies, for that week

Operator

Tailwinds. is Daniel next Carlson Your from question from

Daniel Carlson

-- Just choice between VORI and move you on tight. decide which point, cash TAC, the if I how programs, some is forward on? you one would to a make had to know At

Harlan Weisman

we're let thanks going to Yes. question. to the data for go drive asking decisions. programs, Dan, your of forward and participating but Well, and with we'd course, like both our

treatment, have going also programs. raise versus our for appropriate ability It things depend for We the the competitive both the potential will funds with is environment. FDA to each consider acute like chronic to on to commercially, and interactions

Daniel Carlson

of a million status flu an grant had universal about think, SBIR Can $X the you I then you for, talk program. that? And vaccine Okay. for

Harlan Weisman

with Sure. This is research well It's a collaborative program the underway. Clinic. Cleveland

NIH develop X vaccine, recognition focused which of the the broadly, perfect be Film completed a is non-dilutive the The underscores additional this Thin is IND-ready of vaccine. universal goal animal and this the to begin on formulation an ability including once that's And And of Freezing initial that with a off-the-shelf in say for our probably formulations, the for create away. testing. we'll program as also our program example years we've can applied it's potential financing. formulations. Although, program important work technology the developing work, to such to entities It's

Operator

questions I back remarks. now further no hand call will are the time. to this for Harlan closing at There

Harlan Weisman

who the the Well, faith our to I And support the Particularly the in clinical evening. initial again, our the update. participants today's looking our have once Thank all forward programs and us. of end appreciate good hearing year. of had in call investors, from presenting you, appreciate and we're at data

Operator

you. Thank for has the joining. ended. all gentlemen, now and you Thank conference Ladies

You may all disconnect.

TFF Pharmaceuticals (TFFP) 14 Nov 232023 Q3 Earnings call transcript