TFFP - Earnings call transcript Q2 2021 | TFF Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Second Quarter 2021 Financial Results Conference Call.

As a reminder, this conference is being recorded. I will now turn the call over to our host Corey Davis of LifeSci Advisors.

You may begin your conference.

Corey Davis

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

Glenn Mattes

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

corporate our I call, Dr. will the making and on Clinical to of our Dale clinical During then the update Christensen Development, we internal update programs. provide on I'll in progress are Head us ask clinical progress, important an our and

Kirk for then Officer Chief our the company's review financials Following Financial remarks, the Dale's Coleman, quarter. will

platform our expansion Williams as Following on the will Freezing estate. provide our well Texas the using on Kirk's an as property update of latest comments, of technology, Bill University of Film Thin update Dr. an the at Austin intellectual R&D advancements

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Dale Christensen

pulmonary airway Despite clinical results a currently first studies. our our and intend twice tolerated patients quarter, in of I the dose used I Ib of enrollment from In patients when and data On if data, to upon we today. dosing voriconazole tremendous our Glenn dosed on VORI was dose call We're about cohort. TFF trial XX-milligram safety the for testing XX-milligram afternoon inhaled patients volunteers. pandemic completing hyperreactive quarter to to in in the clinical XX-milligram trigger completion our demonstrated review XX-milligram to understand with asthma and diseases, asthma update trials the pharmacokinetic safety clinical provided have call, likely Phase daily Phase TFF pivotal continue approved. last and you, to joined to who conference study VORI progress initiate that the the complete the of has dose that was the details globally, pursue to we enroll made in were escalation effects healthy up good development of Thank well internal normal to clinical everyone is These the we the of dose bronchospasm or powder and that programs. function our

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and patients will begun have define year. pulmonary of treating with regulatory to interact with approvals to studies for agencies by to regulatory endpoints aspergillosis invasive for the We pivotal end the start file the

tacrolimus subjects to In addition voriconazole study of am to inhalation Phase that all of dosing I I also powder was the in successfully. results, pleased our report completed

patients. have study for are study FDA for in also toxicology we a completed II chronic preparing registration required lung and transplant We Phase is the the that by

in for tacrolimus a rejection. in In During guidance to daily dose blood ml. in the successful levels, immunosuppression reached patients. ability efficiently the undergo therapeutic per rejection. inhalation they provided our We to and dramatically levels blood the Science I data limit and to upper transplant sufficient reach this supports in formulation normal these acute study, allograft toxicology lung tacrolimus our levels of Phase believe, coupled reduces almost total XX-hour with per in of dosed working with are to lung reduce mill subjects, high as XX mean of study therapeutic get tacrolimus, prevent bioavailability while milligram safer kidney what's our patients subjects for required with prevent this maintenance lung exposure for transplant. deposition nanograms five inhaled in is cohort of blood than the transplant the of trough we to tacrolimus of XX tacrolimus day, drug the that days one maintaining needed inhaled the oral after concentration healthy Dr. the seven Levine that and that that Furthermore, found program the of twice levels lung levels a TFF a can oral for the tissues during for that risk Dosing to drug systemic That's tacrolimus monitoring enough has achieve greater we levels nanograms when lung levels demonstrated so our hypothesis to the the other organs, program. powder

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once announced the antibody an lead We've for with currently we AUG-XXXX biological I'd to our Catalent drugs had neutralizes with clinical Augmenta, efficacy as to accelerate can ongoing underscores that that of Kirk? the receive availability. selected drug distributed monoclonal limit the requirements for toxicology like data also of that and created can are administered not therapy could the and it of for with newly been AUG-XXXX, that This stability around becomes turn against that powder to reduction run. selected delivery, Bioworks. and dose a be the newly to work this can of with only and temperature Financial virus. development easily Delta using people that possible, neutralization world. which part antibody, early every also of program. by complications cold And COVID-XX can Kirk Together is dry direct measure because Augmenta pulmonary the a in supplies infected more exciting room Finally, through were process the locations critical means high-risk home for call preventing Officer, potential collaboration the the but patients, Coleman who as binding known we be be chain with we patients, SARS-CoV-X for variants, infection stable of lead This where the agreement screening part results. easily financials. as review manufacturing most ongoing need biopharma means the infected a places to We promising TFF also development manufacture emerging achieved the at critical for is the US Chief more find at of excited at that sweeping provide the their to over update, and compound our lead the The variant antibody to

Kirk Coleman

Dale. much, very Thank you

For the preclinical dry research during Tac. our to and million expenses expenses increased the also development potential The XXXX. net for period XXXX. $X.X million the to company administrative become to XX,XXX,XXX XX, and common June clinical The months for $X.X were for $X.X compared ramp-up million for million preliminary the net compared vaccines research activity average quarter ended were and related million, have same compared Weighted months was reported XXXX XXXX. the testing niclosamide $X.X we three to XXXX. formulations basic of and and company to ended for loss with the product XXXX expenses months XX, ended powder a in of XX, candidates. General diluted three were XXXX, increase development to believe the The and $X.X three $X.X million, the outstanding includes same related due loss XX,XXX,XXX in shares for period and June and in in of activity drugs several of compared Vori to June analysis increased in XXXX

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Bill Williams

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Chris Cano

Thanks Bill for and good afternoon everyone. joining Thank today. you us

pipeline growth As key company. contracting development efforts. three are; internal one, academic on areas programs. for And key our and partnering the These the of previously pharma TFF TFF focused three, efforts. our government business development the three is areas team of growing shared Two,

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on XX new licensing August like of and areas has drug into his everything partners continuing exclusivity closing, is the of BD the continue Dr. research fabric XXXX. our the and efforts team, least Bill team grow of delivery. interwoven we expand TFF and at closing applications freezing In we The Austin as at issued and/or support of focused signature at thank X, thin is in As film our University TFF and with technology into the Williams to I and two transactions XXXX, innovative we Texas technology. the our of TFF of patents. do would filed Patent to company protection at expand

We well-positioned will company. time continue meet over growth for and back today. Thank are objective now our you and it your future technology opportunities our Glenn. both evening. for I to Enjoy your very hand foster to we to this

Glenn Mattes

Kirk, Dale, you, and Bill, Thank Chris.

progress by in Let making short, our and Pharmaceuticals mid, remain TFF for me long-term saying are value confident and you, we to shareholders. the build this steadfast conclude that call

on steady making strong external assets and internal opportunities. are internal freezing these producing film company clinical data we both platform a of meaningful technology applying Remember, our progress thin We to are creation. portfolio positioning and assets value for

level continues business ahead to a Our as diverse front. delivering moving on our already My on as programs team daily existing grow that with opportunities of well The model execution purpose and business on transactions created confidence intensely has focused are partners. numerous the development basis. is significant with

partners quarter. As the to speaking investors that it our open up the turn questions. operator you I'll we look support to always, back to we forward and with and with, and appreciate the And call Operator? next of

Operator

Partners. comes with Jonathan first [Operator ROTH from you. Instructions] And Capital our Thank Aschoff question

Jonathan Aschoff

Thanks agreement was about a I your how and agreement? by if recently me be might announced you Snack lot. wondering GreenLight how energized tell can Glenn, the going is it

Glenn Mattes

Jonathan. Hi are well. Hope you

We've produced So, We've case really about I results formulation. we excited GreenLight. this And make to about comments have the In in stellar gain quite of on really with financing. lot their can. I'm actually the able interactions some generally that good worked they've We've a materials. done partnerships. don't been fact

level do meaningful a when opportunity -- don't this that not an not do where the transaction, We us transaction. to gives get we will can we So, deals there's we a of meaningful do economics.

very, funded positive So, the them. in a step having is relationship really GreenLight very with

right. So, that's now moving they're looks better along that funded even and

the question. for thanks So,

Jonathan Aschoff

cannabis revenue in confident are you in still year? third quarter Also this

Glenn Mattes

Jonathan. Yes

in one launch right now, with I get reaction and and And So, lot So, chance only on we ready assuming they really test be need one we'll forward. ups chance we're formulation to consumer PLUS. move to different of is there's where to once that a no have work consumers. put good the these at And think have make, what position we a done a handle tweaks right? point brand, with are to we formulations you

Jonathan Aschoff

the a Okay. or queue? question, in time shall I back Do for third get I

Glenn Mattes

you Jonathan, do. sure Yes, yes

Jonathan Aschoff

year-end XXXX for earlier mean do Vori some you Tac, dosing By by patient activity? activities and or

Glenn Mattes

Yes.

you your to -- trials. do to these don't take want are that? So, Dale I want

I'll those. let you speak So, to

compliment the team doing the to as job. is incredible Dale Jonathan, he I is want whole -- Okay. an him is that one

the If go look Dale outcomes, that a trials, the at on is think it I time shout out the you give on real big the But amount Dale team to we've here. and been please. budget, time ahead and

Dale Christensen

Glenn. Thanks the question. for thanks Jonathan Jonathan And -- for yes,

will place. dosing. so how place could some for advice scientific regulatory meetings, are those can the dependent be approval. So, our be filings we we're and of file be countries we push and regulatory hopefully, of we we patients then end everything that and doing upon in going we'll handle best but on, approvals. and to by everything to And get the actually negotiate approvals, that into various regulatory -- but based year, our doing And dose of is It can, pushback, to have unfortunately, the in endpoints some

the with thing approval, ready other activated, The end is may that, as patient all of you regulatory you on-site, not know these trials even to enroll. you up sites if drug with have

doing hope that And be everything year. in is going we this So to those can make -- place. we sure we're everything patients come to that we'll

Glenn Mattes

Yeah.

right? report -- So in Vori. So can. forward moving Phase we'll the be of Jonathan, everything some for the by we we the trials we intend the data publish back have end we to And Tac. pivotal more on, data get do to the our -- RAD And it's intend X We'll with Phase headline, year. on X

Jonathan Aschoff

Dale. and Glenn you, Thank

Glenn Mattes

Thanks Jonathan.

Operator

from next our Group. Maxim comes And McCarthy with Jason question

Michael Okunewitch

line for congrats Hey there. taking quarter. Thanks for the This is Michael progress the Okunewitch on and on Jason. the this question

Glenn Mattes

Mike. Thanks

Michael Okunewitch

the Are that So in first to half on we should in seen And I'd data we're enrollment of looking the frame? in short second just for regarding half. in XXXX. for it supposed studies the potentially track if time in X, relatively at ask time lines and Phase enter like, on those? based to still the at look the then, to were how pivotal those we recall you've positioning filings looks time like lines I those tac the be And vori,

Glenn Mattes

Yeah.

analysis of the Michael. year, the the So next we in in trials second first probably believe conclude interim that, done now half. half we'll And have will the

Michael Okunewitch

very you much. Thank right. All

Glenn Mattes

Thank you.

Michael Okunewitch

like, line. and forward, approaching it that going looks crossing then, pretty we're And Vori finish Tac quickly

It view your like in the of collaborations. is your ask, to pipeline form what much platform like I'd comes the So in of next. seems

more this is get think So expect so, internal some to how on we board? TFF, do compounds pipeline additional come that the future of we should about or

Glenn Mattes

I strategy. great speaks, a And our question. It's Yeah. think it to

you're So, right.

generation the cover capital will do that that which And assumption no significant Kurt's planned. fact about also have that we revenue Kirk that includes internal no assumption our from mentioned, is extreme here think a you that no transaction. First is have -- really the trials that we that

And So then, – to look we a portfolio in and So internal at opportunities. for cost other agreed Phase was And preclinical forward. co-development the if yes, partner the you it identifying share going our with that last we look right? we plan transaction X. Augmenta, of on a transaction through clinical work

So assets that something on. be some be to script churning. develop said, either we the that. take company a keep assets It partner I'm could transactions internal and and not or would we it But technology definitively I drug in as we'll But we are, are could of we do like we'll more apply those. saying, the development those

short, growing creation the So to mid, long-term XX. and listen increased this if dramatically. is portfolio I think Chris, quintessential here, now you programs the patent value and We've the to opportunity partner are

I time think the we XX. last reported

with that add just the ourselves. is it's terms surely it's really internal in day we partner or your to portfolio answer this look how every -- either So to do just -- many by question we But opportunities. to just accretive yeah, of more will would programs programs,

Michael Okunewitch

and you And back the I'll me hop queue. All much. then, right. for in very more just Thank one

Glenn Mattes

Okay.

Michael Okunewitch

remdesivir. were you summer formulation last sometime TFF a discussing So of

bringing because their inhalable We up own But haven't it that much recently. remdesivir deposition heard recently to developing the challenges. is, I'm reason due stopped on Gilead

thought with and TFF formulation And example get like difficult as of as inhaled were value the how what platform? can dry of I'd powder ask be So your to of remdesivir the deposition formulation? is, you to a just we prime lung able

Glenn Mattes

to give Williams. who the this its off going I'm and Dr. to did work man the

So Bill could you here? comment

Bill Williams

Glenn. you, Yeah. Yeah. Thank Yeah.

one in in model two and preferred we papers lungs was it So modeled -- the the or that COVID. showed shown and multiple are the that's We deposition hamster for have paper script. the of referenced models, which we I in the rodent in infection one very good

animals So it. liquid believe up difficult. waking goes difficult. knowledge through out. best you to And can a form. the hour we We we inhaled least. Gilead at they to it. believe are drugs And we And The figure to with of our these every it trying nailed we formulations these remdesivir that show spend testing are do it the was does,

and question thank great So you.

Michael Okunewitch

Thank much. you very

Glenn Mattes

That the to terms an would here. is is we effective remain tested, I deposition, right? But problem. example a problem -- we least seen of think it here. at formulation be And how is great application getting therapeutic? be of solved That broad solved their just the drug We has to actually Bill in think only

Michael Okunewitch

very you Thank Yeah. much.

Glenn Mattes

you. Thank

Operator

Riley our And B. you. Mamtani Mayank comes with question Thank Securities. next from

Sahil Kazmi

just thoughts team. the that, that for expanding space, Vectura Kazmi it going on with your be And platform could transaction cetera? great afternoon consumer you good programs brief the today? Maybe Thanks the one our for of, see Tac Mayank. about This kind question across including Vori Hi think you and et see is you into if as taking Philip But PLUS had last beyond think the the for Morris, questions. trials opine those any Sahil Products on discussion closed Glenn, would how a and looking progress on you to that to start. off forward nice

Glenn Mattes

Yes.

obviously, Philip interest I companies. watched in we've the Mayank Morris mean, So delivery

going today creating just certainly on focus sit here and I we're shareholder. certainly importantly the is moving And it. we're opportunistic opportunistic. to execution to But other value forward. we'll focusing activity be I always our that moves be more on some business As think our If so for on --

whole. I now some perhaps look is that's think good. pretty to parts of the because it getting starting sum It's -- I of worth that of whole up more right here the to but are than kind closer. the But remains think catching

forward cetera. more we and every work et -- day, partnerships thinking the just we closing about to moving come needle So

I So that's is the answer whole best there a can question Did I I answer or to way think that second the question. that? part

Sahil Kazmi

that follow-up just do reviewing you very you're you quick about? No, then sheets can that a now is, no. right helpful. And maybe any deal have That's talk

Glenn Mattes

partnerships create that in about these at we're the and me I vivo all But term want we vitro And don't with report we're The signed, will sheet. yes. result And when you'd them. can't it. we'll deal talk too looking think And discussions economics. described in meaningful answer because -- Chris levels hopefully that. will these to we is in have I

Sahil Kazmi

the progress. Thanks Thanks and for taking our Great. questions on a lot. congratulations

Glenn Mattes

much. me Say for Thanks Mayank okay. to I so hello appreciate that.

Operator

question Group. Research Daniel TW next Carlson our And comes with from

Daniel Carlson

the congrats Hey on questions guys. Thanks my progress. for and taking

like level PK for immunosuppression. Glenn, liver levels believe blood release needed drug heart to the what on systemic is can lung and I'm you if for tacrolimus to the used First the wondering, closer have in to data transplant off clinical transplants other can lower a And that shows reason dose far patients you reach so the that kidney.

Glenn Mattes

we you please? take one I going could that Okay. guess are Dale. Dale, to

Dale Christensen

Yes. Dan, Thanks thanks question. and the Glenn, for

low achieve XX, that you In three our that mentioned, compared of of we -- PK XX-week XX% clinical we've that data lung upper about can with shows date the reach limit bio the dose. the the range to blood. higher as can toxicology a tacrolimus to study, is that four fold XX have drug We're in we about we tissue So availability. levels getting to demonstrated what the

high same lung -- in levels into or from gives the have us because a a blood that oral tissue level lung to inhalation, that have the to the to long rejection from the higher what we or we when dose route can the or get the more prevent level higher to still enough blood reduce you itself. oral tissue. push And level But in tissue an the ability have blood so enough the is you from an perspective and

like protective And the can needs be that the delivering think this the down we and that for to to is site systemic level so the it we essentially topically immunosuppression it right would then reduce kidney. of levels where

Daniel Carlson

you. Got

mentioned delta has lead your wondering, tested helpful. the variant the TFF gears I'm plus against variant. delta That's And new you've activity Fauci Thank that against augmented you. if recently? shown Switching Okay. has

Glenn Mattes

Go Dale. Okay. ahead

be you think also. for I going that's to

Dale Christensen

Thank question. you. very Okay. Again a good

-- in of South And the full was but showing beta variant against delta the first in complement that already the have are or identified that KXXXN works last in we that AUG-XXXX year. beta up Africa variant has mutations has So the mentioned mutation was KXXX KXX also delta this picked plus mutation. And that also been data it's N that it variant. the

delta of but to up. strong reagents be we're And a as that have plus. we will testing emerge reason perform these the on coming all new work get able lag -- time in So that again each will something being to there's that believe -- variants takes is it the to that XXXX

Daniel Carlson

Okay. about Catalent? Great. you And relationship more a with then can your Glenn, talk little bit

Glenn Mattes

picked Actually on glad Daniel. Yes. I'm that you up

area pleased of very biologic. the we're So the CMO leading obviously, is that -- leading of fact the in Catalent especially one in

[ph] internal Clorax become -- satisfied So and partnerships all because this [ph] of about before the the fact the pipeline, satisfy product was genesis relationships kind is environment, categories. that and we manufacturing in whole with have Spirit have board produce So of we partners sort can Augmenta that biologics, a they several weren't great really you're Irista right, provider a of of talked never being help beyond which with with discussions an that signal right? and But we now Catalent those now that is maturing of needs So into us We've on help to of right? manufacturing our map our the of evolution except described for GMP Chris -- the there's [ph]. materials here. which

animal into especially critical, develop as Catalent testing getting because and in board capacity to So these beyond, to products, need on get the expertise producing we really is start environment. sterile even products and

I and this cycle think and be evolution it that the running me, investor business, the partner a to is. signaling And a great great at should frankly, the life of to they're the something. looking So it's, -- and that's business holistically in

signal on that, for to up biologic. -- especially is bringing to Catalent, lot -- don't it just a like think -- putting of mentioning on in think, are be I I use we life So should But I the the congratulate, where that. hyperbole. generally, a just cycle,

Daniel Carlson

they're No, great. Yes.

in cold company is on if if conjunction Africa one issues. all? wondering And chain I'm work that. your relieve you've I them So, then in congrats me, has at last vaccine for And anything know, I Dyadic. done that question help working on over been is would could, And a some vaccines with

Glenn Mattes

CEO permission from Okay. say had this. to Well, I their

congratulate So again do is good, I Mark and some with transaction on is want Emalfarb gives Mark to because to which Sorrento, Mark his the now something. capital think CEO it I

candidate. a think project vaccine we successfully just have we to think, So now we hypothetically, look opportunity, hopefully, forward. it's can And -- really have move I and I at if again, that the how formulated hopefully

Daniel Carlson

progress. the Great, Well, okay. congrats on

Glenn Mattes

with case us who on all MDAs have we disclosing relationship with. don't We feel with Mark, because the with lot a In them. a companies Mark, Number that are one, we are close want comment these we comfortable of don't to.

Daniel Carlson

Yes.

it. Well thanks Appreciate guys. jump Okay. I’ll back.

Glenn Mattes

Thanks.

have any or Okay. there questions, time others. are Maybe one we for more two if operator

Operator

will question National that And come Richard with Deutsch Securities. from

Richard Deutsch

Yes. Thanks for taking my call.

a mind pun little don't If here. you

is presentation and heard the business finished I put out term presentation, sheets that a done questions, while, last Your you've in out that couple I thought such are percolating broad a under breathtaking. just I say really heard especially have for quarter. did for you now? deals got the say incredible detailed actually a you right of I first been you It's what phenomenal. review all, of of

Glenn Mattes

with want we but -- be transactions the I to really sheet mean term with are partners. we done just doesn't state. do partners, Richard, sheets in in get going And It clear. we're have have that We these term some place to

Richard Deutsch

Okay.

Glenn Mattes

economics I you put wouldn't right, a deal and want a be maybe in why wanted qualifier something do diligence. look, on And/or But, the to that. And yes, happens to say big I won't well, okay?

said, don't do to are get We weeks. you sheets -- going deal in term two we and people a have and done So single you're some good. that's

Richard Deutsch

All mean, it's is matter Money here? happy term got forward -- that there you're Well, a going I you've with. out right. all it a of sheet

Glenn Mattes

happy have we're either. We sheets. term saying do with them I'm

Okay.

Richard Deutsch

is Okay. other And thing that… the

Glenn Mattes

on -- way. done in to get a my value-creating and be count and get can to team You a deal done me if it there's

Richard Deutsch

projects, to they list everything Yes. And of you progress. Well, pretty I've got are much all which do a if -- as ring. other give them that's whole is the accept your anybody all have thing. One very, -- When some about you do that there's very deal expect But Tacrolimus? can than more hear can or short-term are coming numerous with. orphan you up. things status drug heard I got for

Glenn Mattes

actually for drug Yes. Tacrolimus. have received. actually about status we guess was orphan I ago We or that year That a so already

Richard Deutsch

aren't looking misspoke. for Vori you I Then --? then, I'm

Glenn Mattes

of for Vori, yes, we orphan process applying are voriconazole. in for the designation the

Richard Deutsch

the what's And that? time on frame

Glenn Mattes

don't date, I want right? everybody of pursuing. to it don't So is because at to specifically -- again, I we're mercy the give something want a Yes. authorities, but the regulatory say we're

Richard Deutsch

Okay. going And Are you be also had the GLP results up coming. those soon? to showing

Glenn Mattes

GLP?

Richard Deutsch

laboratory Good practice.

Glenn Mattes

or Help Richards? what Bill do me, know Dale we

Dale Christensen

do GLP we good we of We've manufacturing tox been have GMP our ongoing. manufacturing. all have clinical also and And So we been to have completed to-date. work for -- that sorry, studies

are GTP, GLP of all GMP and we So fully work. our for compliant

Richard Deutsch

your thank progress very for That's incredible. just presentation. you Well, outstanding size. Appreciate much. company a It's your

Glenn Mattes

else support. maybe Thank queue. one more, you, in is the Richard your there for Operator, if someone

Operator

questions, At further this no sir. are there time,

Glenn Mattes

Okay. thank to Well, operator. you, team. Thanks my

support. I line the to your for all on to out want God. But careful there. thanks be [indiscernible]. XX-year My are you that from daughter grand recovering Thank All back. coming still stay of urge I those tell it's old is healthy. you COVID,

healthy I and want you happy. all well and careful. to So, be be

your and for attention. So time thanks again your Good afternoon.

Operator

today's that Have your And conference. excellent day. do you. conclude thank Thank an for does We participation. you

TFF Pharmaceuticals (TFFP) 13 Aug 212021 Q2 Earnings call transcript