TFFP - Earnings call transcript Q1 2022 | TFF Pharmaceuticals, Inc.

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Operator

Good day, and welcome to the TFF Pharmaceuticals, Inc.

First Quarter 2020 Earnings Conference Call. [Operator Instructions]. I would now like to turn the conference over to Corey Davis. Please go ahead.

Corey Davis

operator. you, Thank welcome Business and Pharmaceuticals Quarter First Hello, Conference to Call. and Results Financial everyone, TFF With the Financial CEO of me President TFF; Mattes, on Kirk line today Coleman, Chief Officer; Glenn Dr. is and Director of Dr. Dale Christensen, Clinical TFF's Development; Bill and Cano, Williams TFF's Austin; Chris Officer. of of Operating at University the Texas Chief results our the available TFF Pharmaceuticals release announcing is Press website. first quarter on Please press release. the forward-looking statements take in a moment to read the disclaimer about forward-looking The earnings statements. include release both and this teleconference may unknown And actual these made. subject are differ and from results cause forward-looking that materially to known to risks uncertainties and statements the statements described cause the with Factors results that could actual U.S. and to filings differ our are in in disclaimer the Risk report and Commission, filed SEC. XX-Q Securities of our the Factors on including Form XXXX quarterly the with Exchange section over And now to it's my pleasure call the Mr. to turn Mattes. Glenn Go ahead, Glenn.

Glenn Mattes

thank Corey. for review and Good today to quarter and company's recent highlights. you, us afternoon, the joining first operations you Thank

a in and momentum and activity powders. in our inhaled voriconazole studies Phase the TFF powder this to from continued our from Chief announced successful XXXX ask tacrolimus partnership our momentum Phase this first both a Dale XXXX. weeks Kirk Bill are leave Coleman, will focused progress inhaled participate During Q&A, I we few our II Ib results, please session. for and more call, provide review Chris This of that then meaningful quarter an numerous update very overall and and on Financial year-end the Officer, saw fourth our quarter will first on financials. quarter, of accomplishments, the including data more voriconazole this our pipeline Dr. call initiation which to over just provide to decided our in asthma our time formal commentary will patients that present today's note and Christensen for study build progress for final and strong ago, quarter carries Cano, of in fourth call. Williams Having And the of

third In of began with Phase voriconazole interim inhaled inhaled the licensing This as powder companies has the shared will tacrolimus these Phase milestone in process quarter in to working of late continues the niclosamide studies COVID-XX. a process. partners with in introduce the key That I pipeline Advancement invite a powder year. continued with will our TFF is we pharmaceutical in produce II study Both this treat the II interested data analysis programs. company begin progress and quarter. been to addition, programs to inhaled Canada to event Phase opportunity Partners first potential to Torreya initiated be diligence.

We voriconazole made comprehensive a limited partners use and have a inhaled interest. as result potential diligence inbound by requested when basis already investigators. on TFF established of compassionate powder performing have has available room data a also

and XX-patient April, to we powder in well has reported the feedback palliative will voriconazole inhalation have that across share niclosamide only happy patient completing us We with efficacy and these of results outstanding positive niclosamide development inhaled pharmacokinetic tolerated for first powder. program. shared all this powder The have questions profile his patients should Q&A. and earlier showing TFF serious in advanced very events enrollment cohorts. Dale quarter, in now also during positive was the that data disease more details and was the subject no the for you Dr. target received the After I product with the on physician safety general, care Christensen announced adverse considering Monday. Phase on In safety. inhaled efficacy treating supports be safety study

Management February, potential lungs inhalation molecule so niclosamide inhaled inhibiting which in in Delta announced one which as and X.X X while to antivirals or level, an of completed micromolar to Omicron from equal concentration optimal can completely what mean a potency, Merck exact the variants as assays, safety and into improved of may viral which amount milligrams that tolerability. testing. and the Cmax reflects program in inhibition the produce niclosamide SARS-CoV-X. in results including to potent of powder collaborations niclosamide value niclosamide will highlighting a our of publication. the provide the recent the replication demonstrated A showed no X-milligram inhalation Further replication vitro micromole major and would in safe Phase the the The that product effects respect recommended milligrams of only results is epithelial BID product's product to Furthermore, complete questions recently and At powder Pfizer powder delivered the also the also considered our we us X show dosing be micromolar. The progression Importantly, or maximum view, every concentration dramatically have In that as helped expressed the nebulized advantages dosing at level type viral dry nasal and hope we over dose the II a active delivery, estimated the the to and Omicron of program. the improved XXX the Safety delivery to high safety blood administration identify drug shows inhibition drug the the spray and minimizing patient. be X-milligram a delivery replication. that study Phase niclosamide lungs demonstrated highly of side study's potency II fluid Committee about with of inhibited complete be to the create Omicron of our oral the replication compared of inhaled both suggests each in concerns inhalation for as powder delivered powder, also the lining cavity for the howling XX viral lung, as single in of optimal

Therapeutics viral option diseases. now in compound. respiratory the other on is COVID-XX to Therapeutics has to decision generated assume the niclosamide to further the TFF responsibility inhalation powder to data inhalation inform which Union continue niclosamide as Union will the treat develop potential evaluating We develop and partnership for antiviral with powder a

and scientific steady body and are stream At of of Freezing. year's technologies meeting, of create supported These in particularly methods colleagues and Austin dry and leads the the Freezing the papers significant Thin to research time University X from presented RDD technology. at Williams literature, his versatility Bill data Film of a other of the to also highlighting powder, Thin differentiation at support basic a which development Freezing separate New Film Film Thin this disruptive by biologics. often Texas with over is case clearly this Dr.

fact, this impacts learning Williams one of his become powder pharmaceutical explores look In delivery versatility by how laboratories demonstrate analyze of Film received research as Freezing the which It machine therapies. a the from innovation dry highlighting of unique The on of being Thin aerosol to the research poster recognition. development. to Dr. formulation papers, available. use podium And we they our colleagues and the conducted in forward to algorithms additional

and have from potential we our effort, Freezing during Thin manufacturing Catalent In list licensing forward a that product This productivity global client partnership report look biologics very TFF of a key on of partnership X,XXX well been to for The to a to well to successfully mid- source I of clear in the are multiple and strategic companies, happy candidate. a together. focused as in forward first with confident to And provide arena. Catalent partnering and TFF this balance successes short-, the announced we reporting Turning very Film Catalent work our relationship. particular, together Catalent path providing long-term base I'm the targeted activity. quarter. TFF matches launch CDMO will with this over the in the portfolio. attention collaboration working introduce

Film of business. we continue applications other area focus funding research also the Freezing anticipate activity a could as time. to public our States the provide development with source Medical non-dilutive we During expand, and partnering defense Foundation. collaborations Infectious to United our Geneva that public of sectors the core related cooperative significant for as We Institute government, Diseases of and were consider a sector Army And Thin over quarter, in Research agreement a and announce of our pleased the second

the Thin Film by funding, to Speaking to continues non-dilutive omnibus created work TFF the in budget opportunities on language capitalize of Freezing. highlighted the which legislation,

are We funding groups to supportive fully opportunities. explore working through

build work a in Now to highly looking at with will company is progress House. who on other transaction existing with Glass PLUS competitive collaborations, space. announced transaction This the cannabinoid the recently TFF continuing Products

continues animal of As MTAs working work ongoing And forward a on freshly extreme products work new discussions and portfolio while and been finally, successfully TFF and of the open is are are partnership to have are grow minted, in and inhalation meaningful this statements to the number on under partnership scientific pace with cannabinoid companies highly tested our Pharmaceuticals with consumers. we we expanding the successful that has we path which antibody our in partnerships. at progress been monetized treat robust discussions, see confident results continue will potent as Augmenta models. based to identify to in development COVID-XX on for partners steps In a next XXXX, Augmenta preclinical general, highly monoclonal identified into The many that we XXXX work purpose. of doing collaborations with of enter existing TFF our remain our

the bringing a form new and senior wealth level of also appointments. and talent quarter Pharmaceuticals, The Director of first diverse in saw Board of TFF

multiple TFF As becoming level optimize our the the our lead added a update, over The expansion our and to Officer, of is across advancement the Financial grow will the the advance, clinical a Kirk? for which additions value number stronger company I testing, believe will And to Kirk Pharmaceuticals new all existing required will financials. these Coleman, forging more an fast programs of of call strategic appropriate such to late-stage facets shareholders. our programs We the of new review reflects of turn growth. investment generate into significant in Chief partnerships for and business. of of internal all with of to colleagues collaborations, that collaborations

Kirk Coleman

Thank you, Glenn.

XXXX. the ended and ended the period a the for The the Weighted XXXX. XXXX. were for for research to months XX, million ended XX,XXX,XXX XX, a X the in in for X XXXX. period outstanding expenses to shares same months For million compared company of months net basic X million million $X.X to XXXX, million $X.X same XXXX compared period same loss XXXX, development for for the compared reported company period March loss months net March $X.X the were March XXXX of average million March common $X.X X General for XX,XXX,XXX in diluted the were XX, compared $X.X XX, $X.X with expenses company the same and ended and for in for the administrative

had total At first million and and Glenn. we XXXX, approximately equivalents. over the liquidity of of XX, end capital assets of $XX.X turn call March like million. with of $XX.X cash our approximately included of approximately As to And to that, $XX.X I'd working the cash back million the quarter,

Glenn Mattes

seeking Thank is safely you, market to hasn't could to be Pharmaceuticals this TFF at our in through What the university to demonstrating my being view, by improved delivered being Kirk. one high From our improved. and technology we not believe unique and, created few new places our clearly Film efficiently after significantly demand our question, and that pharmaceutical true doing the to the The need patients. weeks company at position. enviable significant clinic research represents decades. quarter. partnerships, are Since pressing a that quite Without develop way for watermarks progress Thin more conditions been in in all address for benchtop a companies breakthrough call we our ago, work industry Freezing the quarter in drug set we a technology only last have the to formulations changed has formulation the conducted through are the continues and the value technology

short-term of with to against value will investors reconcile the latest assurances provide across progress, shareholders demonstrable company conditions that facet diligently to our As our only business. maximize work TFF the our attempt market to continue can every we

did and inhaled Operator? progress that Catalent, company. continue agreement with a collaborative asset And with and with exactly like with to This our Board expect pipeline yet TFF employees to and turn consultants the announcing second clinical will entering would activity collaboration all I our the data another from for cadence I'd their agreement And will beyond. of quarter, year the key questions. we thank operator stage to of and USAMRIID shareholders the to positive by up that, and for back the powder. and like throughout the open niclosamide it we strategic I steady signing CRADA thank call their also contributions to support. the pipeline

Operator

Jonathan ROTH today Capital first come the Partners. Aschoff from question And will Instructions]. [Operator with

Jonathan Aschoff

Congrats on progress, the guys.

details patients your of can will be that internal And about one know treating VORI For you compassionate-use provide they how additional any any TFF programs, you did? compassionate patients? use

Glenn Mattes

are Dale respond Jonathan, been it's this TFF question the question. to actually, appropriate because X the I to of this [indiscernible]. you is these members asking really working either of Glenn. And questions, of Dale answer I personally, that team that's to answer to all really the the has or would will I'll ask And question. the programs been one ask

Dale Christensen

Thanks, Glenn, and thanks, Jonathan.

give home has to up voriconazole along. immediate ready outpatient, IV And patient to who XX% XX for less discussing spent In the He now function. antifungals palliative received had them voriconazole The imagined now from patient X XX that we The taking were was the the essentially update an study the use year X%. and treatment antifungal idea a of care the prior for getting every antibiotics therapies on weeks. patient his weeks. had treating lung compassionate He be been inhaled the of and the treated has patient and out than So approximately lost lost the was side experienced inpatient effect came and with FEVX as the stabilization. this tolerated. they he's months when aftermath, weeks, patient. starting an seen XX when has This inhaled been in could had hospital last go in of

has on the year. time first patient So forced a it's over for that stable well increased is lung stabilized capacity function. time. vital His And over clinically considered the in

maintain which you levels And things one because about has that, not had on those the the This we have with have the interactions. adjustments would -- to that there adjustment voriconazole, was who dose inhaled tacrolimus interactions. have had this to of patient a achieve the speak drug-drug minimization if his taken would of immunosuppression. to dose patient major addition to his is oral tacrolimus, to been had In voriconazole of positive required as of benefits drug

I from the went business in all has this lives this people's are benefited results therapy. So this patient into this all, because to one person why exactly truly improve from

Jonathan Aschoff

probability results what the do all at and key preclinical Phase signal with TAC, the takeaways? ongoing VORI pivotal IIs? your takeaways of look guys these and you the what I those success as So are Phase in And about

Glenn Mattes

Yes.

thanks. So

a think business I give and So let me a just you to Dale, response. perspective add from probably your think or X minute about I'd

now upon Phase the So as trials probably based the to will company, of bid know think that Is We economics. do licensing worked more. to hopefully and meaningful Torreya on puzzle the that, companies kind we've place assets a patient to They're product. final outstanding you think from our the and with the the quarter, what you will of use third know, with to Ib albeit that certainly Torreya. the of engaged Jonathan, seeing firm. attract think And we latter who and I've Phase most or from company work partners. II this that up a compassionate the glean upon and data of based interested we part in X piece leading X be I we're with Phase X the will really They be

is we from a our look big So revenue piece business certainly, capitalization. standpoint, at a how and this of

extremely you the believe the VORI feel had? how other clinical add. that And to here high. regulatory from you in perspective Dale, have, probability and technical is -- the supply Now comments success you I've whatever always a perspective, free performed please clinical believed TAC has against maybe actuality, of expectations and can I was

Dale Christensen

Thanks, Glenn.

internal XX% the take So problem it's but just voriconazole. used each Similar you as a TAC effective. can to best-in-class. the back, delivered is be programs where -- systemic up voriconazole, of is the put when get to to -- case patients, effective, into lung already drug transplant and enough lung one the the with oral to into be validated the tacrolimus, message the with along step we selected it because lung toxicity enough of for for by niclosamide them get of In the development because comes levels push the significant order have toxicities. In to that up

And topical the lung. so delivery and in has each by interactions been the reduce direct of to these effectively the drug the cases, premise drug-drug lung, can toxicity deliver avoid to the

nonclinical the that data all and premise. date And clinical we've generated support so of fully that to

-- and dose saw of that premises that the for this just I need is that adjustments, is patient inhaled of voriconazole on it the went can which the on tacrolimus one key no As will we're concentrations. be be to the patients seeing interactions. reach and easier expect, we that think limited there will physicians efficacious the fully I drug-drug and for use And because drugs mentioned,

the in cases, as exactly advanced, so expected. they're all as And performing programs, we've

of some better hopes, results data have of well. we high seeing final this generation because than they're benefit we in the to we And hard performing the say are future. but and forward to expected truly it's -- And the very patients look

Jonathan Aschoff

Does or made to have they right decision in have a not opt does yet that -- Union on, a include? and they

Glenn Mattes

you still available to have, delivered do essence, them we're We've Phase reports all the sending. some their I information tables finished as case trials. trial. information know, they believe, Jonathan, in of begin So There's the data from diligence. we to But that we final enough those

went from them to speak list time. get did them I In questions Chris. fact, We to of the diligence a all we this directly morning.

And option. the that they say, development would have they over if And will correct, option niclosamide. option, -- their take of commenced. an the they deliberation have will they period certainly, are has I So you exercise

Jonathan Aschoff

a which say, by time sounded commenced, they formal, have And formal bit a so they you have said yes. has it to

Glenn Mattes

be I letter -- you agreement, it's the people I they and the the the by mean -- we feeling practically, that the my option I period the company's a But period. has case information think down the but commenced. the of for go enough I agreement, should mean option complete they've doing letter is actually are here think I in feeling, believe had launch. rocket have as of all begun. have don't I account by report mean a there a forms, to

Jonathan Aschoff

hopefully in cash, results luck with sooner later. upfront non-dilutive And that partnerships good some than

Glenn Mattes

Very optimistic.

Operator

the Carlson with from next Daniel is TW And Research. question

Daniel Carlson

one kind is of X-part a one here. First

market the the noticed all general by been out-licensing if has process conditions, leads your around And I'm second about you've Just kind progressing impacted can of the that? VORI and TAC wondering any at update that status the to and then that maybe deals you is part this. timing

Glenn Mattes

market noticed statements they're many cash. close have and off obviously, what's are I'll but smaller acutely that don't Daniel, And that I Sure. the open the the have down those But about have that, can't, confirm where transacting. in But ask companies. to in work some we're splits we that and notice really believe work obviously Look, think of going we I now for companies there MTAs the more us, with of with to mean for and concerned or some marketplace. time would many say I conditions the partnerships been the aren't If of Chris anything, not the not. doing. of any slowed this happening we so

any that? come been Chris, we're work that but add the what down think are. I slowed of any to asks hasn't doing, it have down hasn't up, the of any of the exchanged of hasn't do feel It also changed the any or it pace of color the does numbers pace the to negotiations. that you slowed

Christopher Cano

for no. with hasn't -- not to slowdown Glenn, I an and in market engagement been question. for us. seen conditions have the There collaboration partners. to Yes, thanks, due Daniel Thanks, a impact

Daniel Carlson

If Yes. anything...

Christopher Cano

Do to -- talk you ahead. go want

Daniel Carlson

ahead. Go Go ahead, Chris.

Christopher Cano

the was VORI and say timing TAC, Dan. I with the going to on

we're So right preparation now, the process. right, in

We've his data in now. will all doing the room. also a we're data. really the in They're this data delivery the we process diligence currently, Phase room of assembled now, Phase right in comments, earlier work. that from Torreya. all So interim II is And standpoint, of compiled we've data right mentioned data our with the Glenn process. a materials performing focused II is engaged of key as -- right? We've diligence interim us done it's of That be reaching -- We've representing potential the milestone, room partners partners around list really have in out. a do comprehensive all potential So

Glenn Mattes

Yes, we'll that practical. and take

I it, And up but many know last a -- weeks, opened weeks, think handful how don't of about of as couple last the away -- like -- trying we've get just of mid-tier. think new the new to numbers, we're I for the I MTAs. in couple they're

or on And it's as of doesn't do So the technology words, to just other not our all. it formulation, at be pursuit of NCEs, the in work opportunity an seem then diminishing reformulate is most to reformulation. on

So And studies. makes to that look, think, little have company. technology a more but do not chance a spending biotech company. on We're look, of companies help also this, have us say, Biotech money you to a platform as sorry think bit I'm bulletproof. TFF I XXX% also, I of can't a

value, little I how get we're I marketplace. speaks just in it. little perhaps a And to Our us look, bit saying couldn't treated platform but going bring technology And think bit a -- being help is in it, we'll the that and has revenue. I unfairly

Dan. sorry, So

Daniel Carlson

That kind problem. of nicely. segues No

me understand So significance of the to a I'm you trying question for help that if be he the presented that, great. that could Dr. conference Williams. that at would data just

Bill Williams

Yes. hello and Dan, to Thanks, everyone.

the breath work on Thin had were regularly of And fact, in was data competing received. same RDD well Film and of work. X our DNA the presentations meeting, we time. the So biologics, plasma able in referenced is very technologies. some presentations, in of voriconazole, different we on at to It that talking present I other some tacrolimus, platform now new Freezing applications the by several other they're was And the the during about the speakers

that's good. so really And

context throughout that that the was presentations meeting. the So of

Daniel Carlson

of to COVID-XX. talk And for question potential for kind me, Glenn, niclosamide. can and one the Maybe then Great. Union just last you about the related niclosamide beyond

Glenn Mattes

Sure.

conference So was nice just their around see. really I to [indiscernible] Catalent the chunk on referenced. Bill work and clearly a TFF. a made That to presentation big was

the antiviral. there's tremendous have exercise So infections thinking a scientifically opportunity. potential perhaps about IP RSV niclosamide. dive and what VSV, with looking an validate with why. viral but we we're we work Dale are us amount also I'll most potent looking clinically to But and for a pricing. broadening into speak into the deep of think around analysis. that We to that the horizon. that, at It's We're there what went if We're would We've are talking strategically engaged have. extensive at would the a pose group we any to helping doing those is there We're issues, payers. are that

those along So path X the next and have what's trials hypothesis, in understand we're working of look deep data for clinical our clinical to sort that. We'll to go validate forward. the scientific like, might to costs best with X a dive also to what Dale's doing weeks strategic up

be, important So good the we what understanding opportunity of not only might significance be. business have a clinical might but

you those helpful Well, data that clinical for add want some well? we their out deliberate see Now that. right Dale, to first now, do these do help Union after also be on as will this have the our to path think on would them forward and commentary Union we go options to outcome. own. And

Dale Christensen

Yes.

broadly existed addition to as a activity published been that it as that both that coronaviruses eye as area in out is And that well active strain. And while, in for MERS all RSV. it in the out SARS was against type X-nanomolar has has with RSA that, there A published time the information East so against against came B Middle the coronavirus and XXXX a the niclosamide So ECXX agent there emerged original showing XXXX coronavirus frame. to is that's clinical

these that it's a broad-acting pneumonias. So cause viral antiviral respiratory viral against pathogens

viral. the infections. would their of And there's would respiratory this. for a amoxicillin that could a be think and the respiratory antiviral that they we vision doctor, so degree high experiences be call infection ultimately, it get be severe And that patient upper of a They

Daniel Carlson

And you. next helpful. Got That's for or COVID-XX maybe available whatever. the

Operator

Mamtani next our B. is Securities. from And question with Mayank Riley

Yuan Zhi

for of follow-up. and the on then A looks us for plan Could Mayank. quarter And all team. safety new you to to Zhi quick on like the each that first the and analysis the internal on targets quick efficacy the question the remind interim is trials? programs the terms This then Congrats X the what a you on of in and points enrollment report? of end additions

Glenn Mattes

but decided we -- we just we know -- would to Dale, just those, [indiscernible]. disclose you you it's if have,

Dale Christensen

Yes.

So we both so -- but I'll -- Essentially, analysis. disclosed the studies I to enrollment we're haven't targets interim of are the the what more speak open-label studies.

therapy hit and it think to difficult can blood about an imagine, is As blind you really especially to adjustment require a level, and you between the oral oral dose inhaled therapy, can when that. when you're doing an a how comparator target

the due clearing for dose case CT to So and fungus. the the things overall salvage of like in cultures at requirements we on looking completely well we're things to therapies as if are see using chest dose discontinuation survival scans endpoints, lungs voriconazole, like objective adjustment of as the going to

the the label this the there And -- so of interaction kind in looking monitoring. in of patients at, and or mentioned the oral with other like will and many so all between chemotherapy things trial The analysis interim an treatment of very would endpoint. drug-drug type and accepted the objective clear are interacting we'll determining going objective more the the you label because in as because tacrolimus before, case therefore, and are, is generate In we differences have that your failures also and drug-drug involved that don't are inhaled open endpoints do on judgment that open be be endpoints, interactions more to require require -- drugs CYPXA salvage therapy. therefore, because study can

voriconazole so fungus proportion in other the many overall overall and to to had of perspective, of adjusted many clearance then stabilization have CT achieved the infiltrates. the essentially reduction their scan medications be of patients that achieved clinical the chest the a from how And due lung, how of will kind and concomitant introduction safety it from

try So the but of are this either point physicians trial, the are are study all holidays because kidney to or voriconazole patients the toxicity kidneys. doses reduced -- their all are open into tacrolimus In that going armed those to that are these and things of again, come drug significant significantly are spare and receiving that oral it's TAC will trial. contemplating one the experiencing out the the it's label, VORI

improve? we So at can can of creatinine we stabilize? biopsies Or we then does looking it are stop techniques markers GFR. there's it Can reduction the different efficacy the kidney rejection going that from different looking will and the endobronchial signs of several if And either acute or even in biomarker tell that using at from standpoint, in lung. stabilization on function, in see stabilize, increases can us the we -- be

continuation of be of and lung the able function. kidney the along of stabilization So effective prevention compare in immunosuppression we'll to rejection the with

Operator

a from Pogesma Anthony private the And next question [ph], investor. will be

Unidentified Analyst

could up the you us ACOM the I then and was could and with the UGA, on wondering give updates give followed on Augmenta you program UPenn. status if any

Glenn Mattes

on have looked at innovative the certainly antibodies development. We've We've its preclinical and over-the-top armamentarium binding. we you with the The our positive SARS-CoV-X I'll been in level very been animal against Augmenta, And And taken really what And know, all positive variants. XXXX as give know, seen potency the in an is work you company. we've has the Okay. unique variant We've successful. in seen it's a common program. the seen and Augmenta the molecule models this variants. and monoclonal very enjoying you the as with have neutralization theme, treat at not that seen become other Omicron that We've same to COVID. been in neutralization. been overall

up very number bit Augmenta to a turn with continue want share of to think develop in XXXX. we have It Because right what how ideas. tip the ideas don't to very from I of, marketplace. think, to We of we where of come on a creative don't I is rest want headed. terms the the unique, those to they're and we've were I

you one We think has We clinical something we that don't need help not. that, add believe still that add or to us Dale, a I believe believe have we and anything strategy. also you want in to compound. board of still to if don't Augmenta, scientific advisory tomorrow. we And Dale, in are the working to that but monoclonals if members in with I know COVID-XX value. we there's today treating that for our know want to craft

Dale Christensen

Yes. Thanks, Glenn.

and of out, ongoing commitment Glenn variants emerging is at the part As as to they looking monitor pointed occur and our activity.

every as we with seen So as now, VAX especially had revoked. variants we are already or the proceed, with either that and Omicron against emerging various And removed and given works. you've commercial EUA that's there's it antibody the ensuring testing variant, been EUA been

it's a now right so world. difficult place And in Omicron antibodies for the

activity. still And of assessing so all we're that

Glenn Mattes

your repeat second -- say question? you Can

Unidentified Analyst

could with you UGA, lines. you're along if doing UPenn any give on updates on those It was what

Glenn Mattes

Sure. Chris?

Christopher Cano

Thanks, Glenn. sure. Yes,

So academic Albert collaborations, mentioned had and on UGA, UPenn. Einstein you our

a one time. So take I'll them at

study in with right? working at of large in Einstein, process a dry of done conducting So completed successfully Chandran with hamsters. the performed researchers We've this Geneva performing Albert the an and our we're testing COVID. Kartik the USAMRIID at study And We're is Dr. collaboration their with vitro efficacy study vivo in VSV And our and we're powder. Foundation. for being in

Dr. at Ross doing very In So work the Dr. Ted about excited with with UGA. Chandran. we're collaboration

versions prepared as that That's adjuvant. one of we've an has powder their dry influenza AddaVax the vaccine. So universal

we've testing both that that allowed us in and powder our to dry the efficacy. so completed in And powder vivo dry and ferrous immunogenicity in vaccines, preparation on testing maintain And confirm mice our right? and vitro

very performed Our dry powder well.

So discussions version of we're in and clearly MIG into how steps with their on UGA influenza next universal on and the vaccine dry powder our TFF clinic. advancing defining

so for completed animal collaboration commence these formulations. we're and lead powder our future. Weissman preparing studies formulation Weissman, that very Dr. optimal dry near UPenn, testing, Drew to TFF We've with Dr. to can For our our work. protocols we've mRNA initial We deliver identified they our in finalized animal the samples our

all continue collaborations. we on very our to push hard academic of So

Operator

question Deutsch National from with And the Richard Securities. be next will

Richard Deutsch

get to get broad into almost trying X have sympathize too specific. to with call. people I to And there's landscape

to little to enough Aptar, commercially going they're come I'm in Exchange. of is question milestones? conditions, couple commercial $X.X just they next time -- over do bit business decided move Stock them. tell And they're and get on about even partnership to forward what what did us partner their But if So another to major means? if to a they're X which a have you to this how York It's what Can months? And them, billion ask X successful. this back and and which just looking the you corporation. And have you been announce XX know don't market major people the on New

Glenn Mattes

First Chris went noticing I'll credit diligence of guess, We out on that. for gets Richard, that new and corporate doing the press out a his with all, release. this Richard you, a put for I commensurate notice thank the I have presentation did one. all

transactions. does, the he as frankly, for all So

I'll him So the there. you have details give

Christopher Cano

Great. Richard.

So Aptar. with is initiative. really about our partnership new This a excited

the So TFF intranasal in our dry powder is for concept formulating an device. use

TFF with device. intranasal using and So their proprietary working Aptar

dry experiments that some proved for is experiments our therapeutics. powder running only we're So initial vaccines we believe not this And initial successful, also brings these nasal for attributes, if right, but TFF for unique administration. and

both So depending be patients states, and very on advantageous this and disease prescribers. the could compound for the

fielding of we're is structured inquiries that you right? the way similar very powder are And can the looking delivery, many dry deliver at for it's intranasal customers Aptar our from So intranasally. partners, TFF,

then respective TFF Aptar collaboration dry powder and respective our of device our marrying can needs. proprietary each the to customers' is drive technology The concept the with our address we technologies. So

where depends compound could I the spray it powder on as state again, vaccines So intranasal disease of advantageous mentioned, really dry and therapeutics. and delivery the be for very

really We're experimental right So some work doing now. concept. proof of it's

continue So forward progress we I with the road sharing down to this look that. as

the So thanks question. for

Glenn Mattes

is visit the to a inhalation opportunity doing their have in ago, with It an team, the as Catalent We, and Boston, partnership. is well. which synergistic work also site they're really nasal weeks as just a site of couple

work anticipate And not in to space. a at time. get the come Aptar we're we a better the opportunities intranasal that to lot more could So relationship going

this all together So is coming nicely. quite

Operator

Ketterer is Next TK from with question Associates. Ted

Ted Ketterer

X/X the Glenn, and what to room your cash. be is very in of balance candid, the elephant sheet

to position And are your at so companies happen balance any revenue. scale far, to who the Or going in going incoming there's of something guys terms run expenses. partners. a get than progress is out matter new stock. in but the got new of about million there doing fact companies with that's okay, are is you're [indiscernible]? sheet diluted that's you in a My going going are no it expenses shorter the fabulous, of sounds people it you -- X $X adding question -- to rest of the like The quarter depressive for cash we what is, that put is, and Can to you're And people where X you're a are $X share? market adding

Glenn Mattes

year, Well, just to you, next capitalized the of we through correct through August. to part almost Ted, Okay. mid

we We than more are capitalized. very X have believe we So months. well

that. I this optimistic on And our that nothing manage about leave to revenue. our say capitalized. And with business call said that. model. transactions are model We've budgets extremely close repeatedly. know have meaningful at to You well else talked our our I'll extremely about business We're I than it ability We we well.

Operator

Capital Leo And Washington the next with [ph]. Serresino question will be from

Unidentified Analyst

regarding et vaccines, down you Glenn, percentage the be of your along open mRNA, got Would a mAbs, question versus those lines? what cetera, are to MTAs. MTAs break I biologics able

Glenn Mattes

[indiscernible]. going friend, knows, Chris put a but he on that of know may Okay. to my spot Cano I'm here, he not

out, Chris, So try please could you if do.

Christopher Cano

Thanks Leo. the Thanks, for question. Sure.

tremendous on different I our take our biologics. MTAs, if at in a collaborations, of look So right, a all ongoing focus we have

all NTAs, the biologics as Glenn on focused XX% really all the biologics. or are right, them technology. of of partner different of are of -- to of And NCEs, earlier, we're our over these our to mentioned had So originator

projects, I focused for on if these of to are share XX% dry is more XX% a biologics stable primary can Well, route inhalation, injection you, Leo, powder of as of dry projects, right, which So administration had oral of of that these as of I versus and more of collaboration projects are -- our the of reconstitution with over We're the XX%. what right? administration. route our powder

number have couple a But which alternate large, of of projects that have large We other of projects administration. routes there and are by a overlap.

powder. on and powder dry and on at Based our our So new is with partners with second that the looking demand, Aptar now a inhalation we're working And oral delivery partner we're now intranasal vaccine. with project an dry arrangement. of engagement

context and is of hopefully, focus are. and little question, So where gives Leo, your MTAs our that a you our addresses where

Operator

follow-up from Our National with a Richard final be question Securities. will Deutsch

Richard Deutsch

VORI, you on niclosamide, purchase, more thus running Glass of Ted's You just development presentation And us did about the comment enough I mention plan soon and higher be a you your inventory levels your higher in money. out alone product one a of how PLUS House, make about Products. company. and interacted which of start would those purchased programs evolve Obviously, TAC, monetization to has into cannabis to just give bit that see business want with -- question products, themselves And can government update separate commercialization. a has had decision on might of finally an little we

the throw done, over year in wanted to products X. final So comments as last that of I you've the seem of just out stage all Ted's of what be reality putting into with or to line these

Glenn Mattes

Richard, Yes. Thanks clearly. other and the for opportunities, comment,

have But our compounds. possible. as has But the interested, certainly. I very as this have we've this -- in get PLUS the House. impressed They've And House. is feedback what to from a Specifically, test Richard, Glass talked quickly hopefully, I said And in to as it's first to do we call contingencies. to we said, the have Everyone through us we Glass formulations. our us in is believe, I will call, PLUS not again, this these them PLUS with foremost, have culminating we our to been place contingencies Glass management we have House Congratulations -- have after assets. marketplace partner all is to compounds that our we helped assets, time, with in I remarkable and us go-to-market develop restructuring helping The their really for marketplace. go-to-market

are got at look productively. possible, excited PLUS take but that formulation here. we the terrific to help as we've sale And marketplace. the of our use goal to as didn't timing And is So first a situation timing, the about commercial realizing the opportunities array get quickly we really with into

we're mean in the -- gave reason how I want of The then I period for be an they're most we is out on spirit intellectual big I Union Just and to I the is clearly the use to to engaged. work partnership answer understand to bringing that's numbers. make opportunity saw the opportunities refined that views of personally wanted that niclosamide -- the And -- doing look doing sure concluding, to the is and that Union. we the the in We at and partnership. all the doing a before the work our want work with option opportunity niclosamide.

right the there. I'm makes all decisions. indicating So the partnership That's

other So the than in is what there's nothing agreement.

with We Union opportunity, the started I have first or data it's gotten doing the with we program. than And larger work much the first great if anything, niclosamide Phase Union. out of engaged

investors of of value be term market in my all to darkness. doing everything believe there. So your seen in there, thank will we -- even and will is is to than perhaps summary moving splendidly. period realize want and you that possible. the I'll you we're greater are can is great And come shortest my I than sure And this thank but are comments opportunities the that think bigger I to forward have Everything company it The team, TFF out may the end that support. TFF ever. you return

you. I to quite As available know, make myself you

evening. me your you questions. your have or thank contact I questions Corey, hope answer stay well, you we'll if any can you, any time, enjoy all and you So at and

Operator

now attending for you Thank concluded. Thank The has conference presentation. you, today's sir.

disconnect. You may now

TFF Pharmaceuticals (TFFP) 12 May 222022 Q1 Earnings call transcript