TFFP - Earnings call transcript Q3 2021 | TFF Pharmaceuticals, Inc.

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Operator

Greetings, ladies and gentlemen, and thank you for standing by. Welcome to the TFF Pharmaceuticals Third Quarter 2021 Results Conference Call.

As a reminder, this conference call is being recorded. A question-and-answer session will follow the formal presentation. [Operator Instructions]. to call. Davis like to LifeSci now the begin would introduce of Corey Advisors I

Corey Davis

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

Glenn Mattes

quarter company’s today us to operations for the afternoon, Good you and and highlights. recent thank third joining review

with Thin Christensen CFO, Film highlights our efforts. Dr. review internal provide of progress. clinical Vice update the He just our will corporate President comments, my Freezing our be update Then last are on Business outstanding on will Kirk new programs. Bill I call, generated finally, the Williams Dale us Coleman, I partnering making and After by quarter. we will overall of results. progress Chris data will this financial followed update update Officer will our And our in of opening an Development, on ask Dr. to During the will who Operating Chief status the Cano,

begin Voriconazole internal Inhaled to line of a the The program. extremely pipeline. program, provide area These initiate the data X TFF are with end milestones update. will We X allowed and and in provide significant discuss third too quarter and in have us and TFF position of creation reported have Phase outcomes by mid to Dr. a The Phase dose confirmed greater we’ll during to I’ll and was Xb which study upcoming TFF throughout select milestones of the reviewing manner our from many by These productive value every to significant in results and been accelerating a from in our positive long-term top short, details. timely almost the to both safety development accomplishments positive XXXX continues year. the Phase this going business. the Christensen concluded this I’m for period. pivotal

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the and status We will and communicate of ongoing this negotiations. work update

well the mid We and and and Development, have Chief call, our be every Later view Chris that are our detail of near, who I Dale? will on Operating programs reason Dale in evaluation numerous supporting of progressing Dr. the efforts long-term and turn opportunities internal will provide will over to how will value. confident the Cano, technology on Officer the drive Christensen, shareholder expanding. meaningful will our result details as Head now to this effort call total Business more provide development collaborations on our portfolio. as

Dr. Dale Christensen

and joined today. you, to Thank Glenn, everyone afternoon has good our call update who

quarter dosing well been cohort. dose and we full and Xb has inhalation observational asthma the escalated following dose has data cohort patients, selected twice-daily the clinical dose happy XX-milligram dose, VORI starting Phase X to completion is announce found in continue our of has proposed we is enrollment for Initial I to an in study. shows TFF completed XX-milligram patients, great provided and tolerated am I enroll had where well make in in that study. internal the our dose The and the asthma third the we been on XX-milligram and us, that powder Last for XX-milligram that extremely been the our development busy voriconazole Phase to for programs. quarter, patients the as update study of we’re tolerated progress that

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Health of for Inhaled we normal inhaled our filed niclosamide to on prevention the treatment developed COVID program. CTA volunteers dosing study In dosing announced anticipate start-up third the subjects of and healthy first XXXX. dosing The weeks inhalation being efficient inhalation with had we represents Moving The of approach quarter, progress are to the highly The for received anticipated has in letter complete work powder and in dosing the and a the that will will soon. a powder. Canada begin at of niclosamide And niclosamide in first dosing. we this first or to our the able believe respiratory we trials. niclosamide is proceed we other early we from a and couple should our objection completed site smoothly. viruses knowledge to recording, Canada powder be very recruitment be A be encouraging, niclosamide the with time no promising and very to with to would associated ago, COVID clinical dry powder that antiviral infections. gone

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Kirk? antibodies because Kirk receive by the receive created infusion antiviral be Financial this achieved run, instead to the administered to to easily the that this requiring an like to locations TFF people in Chief deliver future antibody about of patient dry can for to first Officer, the at home pulmonary to using powder stable oral more the manufacturing be I’d go with will be can potential are dose efficacy well powder dry a that the be slow that lung. every delivered drug the review infusion. This provide more come regimens. the reduction making also update, for can and without antibody over drugs tolerated combined turn systemic by an Antibodies antibody. the toxicities the the can to of inhaled We for direct It center are administered than excited possibilities process that means the financials. the of Coleman, infusion. that call Furthermore, delivery our lack can for the economical And with infrastructure antibody

Kirk Coleman

very you much, Thank Dale.

parties months to XXXX, third and AUG-XXXX, to increase X several XX, September period the along TFF of million same for company Weighted candidates. niclosamide, to of research third we VORI, manufacturing our with $X.X increases to the out-licensing or clinical of to due $X.X expenses of compared for for period $X.X compensation. months was for were in ended diluted shares million expenses and X to research believe related powder in reported September million the The a development during development our and the administrative were General TFF vaccines $X.X by expenses technology XXXX, lead stock-based formulations for may that common average compared were XXXX. preclinical with in XX, in dry and months drugs ended The increased outstanding, product same ended TAC research XX,XXX,XXX $X.X X analysis September compared and loss and XXXX. of XXXX. licensed XXXX, $X.X The XXXX. powder For million the a loss dry net quarter costs, for compared and XX,XXX,XXX expenses net in million basic million includes preliminary the in and and owned for the TFF also XX, development expenses testing XXXX of increase and expenses payroll-related development the in company

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Dr. Bill Williams

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Chris Cano

everyone. afternoon, our team areas the three, is are: our development pharma areas good These and Thank development and three efforts. two, growth and contracting Company. you Bill, today. three Thanks, key key internal the growing one, pipeline TFF The government for us business focused programs; on efforts; of for our and academic joining TFF partnering

progress of tremendous make to in each these areas. continue key We

The increased For number efforts with today’s of both, lead active has we in collaboration projects. additional academic to pharma call, our mRNA call. with mRNA companies on significantly discussions in last our partners our be mRNA very and I continues focusing be other collaborators. discuss our will space. to And earnings the TFF are since projects

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As Weissman mRNA making previously, BD partnering Dr. efforts. the very been stated our formulation progress TFF technology summary, Glenn In is of future supportive being has work. TFF in of the part team tremendous

of continue Thin our with pharma the continue Texas to technology. We I partners Austin. like at would academic closing, our University of expand partners at we Freezing thank collaborations of grow as the the to to collaborators and number In our with application Film

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

Glenn Mattes

call, congratulations leaders all progress progress this TFF our Thank communicate able you success. across of we’ve trust business. making on to the and is that to who the facets all and I on of outstanding been the TFF presented

questions from developer share Board TFF business to much value has as to model make to we recognition that past on the TFF’s we’ll and made shareholder of areas biotech the expect we being products, portfolio medical accomplishments believe this build platform the not with upon realize in in so this companies, portfolio and understand certainly look need. base, leave that to proprietary been unmet the investors We arenas of period near-term the for our high partnered the for investor that opportunities. for recognizes in that Over management for I not medical quarter. of are also and all with the to strength have I call, business business we both that my shares and the progress Company. the for we’re and of pharmaceuticals most realize opportunities and have both high innovation-driven end next challenging been decided potential for portfolio steadfast data internal do of our us remarkable unmet call. consideration, time, proprietary TFF We from a we received in need. trials your both, partnership clinical trend. you, fully that to future week. The the with have making at we’ll continue development based company, value an TFF will forward progress view, with areas well apologize of time The our in and track put confident is TFF but growing again progress had Our Thank few the immune current TFF of in you of In therefore want small-cap success and addition sticking months of And creation addressing investors the to we we sharing significant length creation with therapeutics it more their reward believe ongoing to Pharma many a value and we’ll reassure for technology of information as and you well-controlled institutional here in shareholders. value this hybrid our decisions creating internal model our for retail remains healthcare-focused programs. the and business of are our and us. for the generated every dynamic

our certainly of As lot all investors I And questions. and the that, listening. answering always, the will support to appreciate Again, thank you open up with spend for operator the of line. and the partners. time we call a back We’ll your turn

Operator

Aschoff from ROTH of come line Jonathan with Partners. Capital first Our Instructions] [Operator you. questions the Thank

Jonathan Aschoff

congrats guys. Good for us how My on quite first and question it’s ‘XX progress. around Can next you And evening, so with Thank for the year expense given far? bit you. a XQ this is year, the help Kirk. trends R&D bounced

Kirk Coleman

-- expect clinical will the remain around next off year as fourth fourth previous same higher the I’d And are to quarter to. previously. the that Jon, after tail next QX levels point three trials be at quarter. I off had happy this then here the amount manufacturing then, at the clinical a Leading for kicking we would that in year. to than trials that of increased begin in quarter, because normal this mature, into

Jonathan Aschoff

looks this third of quarter? quarter, the saying was you’re lighter, it So, that quarter in I like half what mean fourth

Kirk Coleman

it be lighter, concurrently running I in wouldn’t it be trials next that be start year sure. three going to trend off but the time. at the will going -- it say There’s to would for be to same will

Jonathan Aschoff

Understood, status vaccine Biosciences of clear. Can me update on understood. please GreenLight an Thank the you. the give someone That was collaboration?

Chris Cano

Jonathan. Thanks, Sure.

we very good So, continue to with make GreenLight, progress.

mRNA. their received have We

We formulated their mRNA. have

We have testing now at And samples. them back right there’s GreenLight. sent underway

I and with But, all very our and about collaboration. making actually we’re progress can very continuing we’re That’s GreenLight. good with disclose So, we are discussions about our at GreenLight, time. collaboration this excited continuing

Jonathan Aschoff

estate. on any us update Can additions recent you your noteworthy to patent

You ones standouts? that any mentioned XXX. are number, But about the

Glenn Mattes

Yes.

new on So, have therapeutic area, patent. wherever focused we our technical strategy very, data in area been pretty or broad specific we a has compound very filed

materials, So we’ve learned pretty areas And siRNA the made wherever field anything patents we’ve really of there. recently of mRNA, filed that in especially around for example, in progress, use Jon, patent expanding portfolio beyond a quite of biologics, method also the also we we great we broad and world. on those rest file domestic expanding in patents bit the working of across our with the focus and process those --

Operator

Securities. come of Riley questions the next B. with Mamtani from line Mayank Our

Sahil Kazmi

A on of This afternoon. questions Good Mayank. Sahil Kazmi team. is for Hey, comprehensive Thanks for update. really us. the from couple

relates you seeing augmented the it from the about as to Merck niclosamide and program, those in programs, off, can and the First how developments talk of you’re value space? antiviral recent given the Pfizer

Glenn Mattes

Dale, to that, I perspective please? you can Sure. give on ask

Dr. Dale Christensen

you. Thank Yes.

very address effective, it also terms foremost as while Pfizer augmented niclosamide issues. in -- this. the -- been that I’ll so, for of some has niclosamide value first or And essentially, from in has well and PK the as And first -- is

so, long And with to it last ritonavir make administered has enough. be to it

there can develop toxicities through And combination. that systemic that are some so, two-drug

a clean as quite drug. not as it’s So, single

this higher and both, Merck they the levels. they -- is promising, compound, the results, have that Pfizer all have for thing they other to are while the competition, are to you is -- applies and The systemically delivered

as showed the directly we’re the the early. could site animal if is -- of intend severely drug previously, animals. compound there we get effectively there that infect toxicity, I to could And infected more more we you Merck systemic we to We or results, possibility the mentioned compare, compare infection. right whereas treat if delivering so, And you our to of

think for we better there. that efficacy is so, And opportunity there an

a results going we or problems. to certainly, just market so, are don’t think that create those And eliminate

other is thing the niclosamide a that activity. spectrum there is with The broad

work could has kill -- documented with work it RSV been to it already our So, as well influenza. as

be a So, the niclosamide pan-respiratory viral product in the future. can therapeutic

Sahil Kazmi

of end and you size into what then, done to do color anything sort you’re sample to getting sort TAC perspective might qualify provide could and the it TFF or business year? of a discussions play basis, a on or maybe able to sort of duration patient as little biopharma expect interim the kind more a we plans your you long-term disclose, analysis activities, some And And transaction? size more exposure a And activities from by of the the the for best development meaningful the how program? for you of ongoing of then, with any to relates start can on

Glenn Mattes

start I’ll BD. Yes. with the

that number analyses have month. we described, data this up a of Chris are partnerships as some So, wrapping

sheets We we’ve is that on gotten have already term the line being and the assume work, that diligence performed. to finish

of have end agreement. transactions to high we said those November desire equal doing happen. can. end likelihood, by look, confident that our treaty I’m we’re XXth, But, to cooperation the the year, and partners, likelihood being and partners get will on close there’s the Chris meaningful the we takes the that things line that it’s to signatures the finish to all And still It So, that are that hopeful we everything from saying by aware get the understand and of or the well two the are getting reasonably ability a think year. we we

We we many that things calendar the the end outcome by that remain the of confident the have that will in year. be so funnel

As to the TAC turn to program, Dale. I’ll again that over

Dr. Dale Christensen

the Sorry. TAC? you question please on Could restate

Sahil Kazmi

Yes, absolutely.

patient size analysis study, of including Just duration patients you Phase think will for that do qualify number you’re wondering of of kind sample the the transaction interim X planning. at exposure, meaningful size level the the of what at And point? or biopharma

Dr. Dale Christensen

Thank Okay. you.

a the demonstrating designed will from This efficacy gotten for efficacy So, would is X. set is X study the the one the a case Phase where that really feedback stage FDA be required. study we’ve Phase already that is

targeting duration XX so, we patients, we’re kidney already where XX be XX toxicity. where oral on they patients X, coming would of treating in Phase planning -- but And are and the a for to days will significant the experiencing medication, on

their are protect to levels so, ready to tacrolimus physicians their reduce And blood kidney. the of

is inhaled maintaining rejection. -- going higher so, or they’re go level are since a with be level lower with to for reduction, the the systemic plan tissue on would idea planned lung therapy a they already prevent And coupled to to being the the

then And from at And look blood they to to the bronchoscopies, oral rejection. levels and end, levels start, from can that inhaled. also lung then able bronchoscopy bronchoscopy predictive be get of are at and the we will so, compare we’ll the at the biomarkers the

information so, into to need we’ll we give And document on Phase able that that us the move X. in be to will That study.

treated need what to about imagine, in be can the end doing as patients it’s XX So, very we’re are patients this and case, will label this the XX objective. patients And before. to open exactly and because getting the physicians know XX are you all total, points

Sahil Kazmi

back you all Excellent. our appreciate the questions. progress. And the on in I taking queue. I’ll jump Congratulations

Glenn Mattes

you. Thank

Operator

you. Thank

of Our with Okunewitch Group. questions the from come next Maxim Michael line

Michael Okunewitch

aerodynamic So, while for -- particle wanted to stability? properties millimeter the provide the the Thin you proper on protein ratio having maintain you the allows as relating the area Freezing Could scale greater to scale to that size that to surface lower for how stability. you I Film ask something being micron opposed discussed talk to the about volume platform

Glenn Mattes

Can I ask Dr. Williams to answer question? that

Dr. Bill Williams

Yes. great question. Certainly, a that’s

I ratio. Thin freeze, had quite the to, that large, applied size for size Freezing is what actually, was droplet And to the compare Film the And low droplets to -- several we of published papers not the are between on -- millimeter volume to the difference have to actually asked speaking very got area often diffuse freeze Film just spray and is talking to I area Thin is we the ongoing So Freezing surface drying. -- surface was are about lot means protein what we’ve have get to studies of a in this. the there’s technology, which

in hand, spray freeze the are they’re very other the the size, On small. droplets liquid so for drying micron

so, volume as very high, literally X,XXX to surface high there’s And a like ratio. times area

not to the I speaking what to, aerodynamic necessarily particle size. was that’s So,

aerosolizable these about products different for -- does high been the produce very for powder Our that proteins. powder for we’ve the talking

question. So, hopefully, that answers your

Michael Okunewitch

PD-Xs alphas. successful like I’d about both bit you. the you mentioned to most then, some all drug to time. touch -- a were it classes on before, Thank TNF These applying of talking are you also of TFF does. Yes, And and

targeting classes, So, to and more considering is TFF a lung broad drug disease, the something is or this for platform? of the you’re and off-target significant in show inhalation, this power looking drug effects at new for these the a toxicity proof-of-concept applicability just for localized

Dr. Bill Williams

And doing we’re question. latter. Yes. it for Great the

that to every different from antibodies, can anticipate to we and be We are learn of those different proteins. property physical try models using chemical as able different

model, that are And necessarily as something a not product. are it we so, developing internally using as we as a

Michael Okunewitch

hop the one back more in queue. I’ll and just And then,

TAC, there previously thinking path we potential Phase How looking for So look now enabling. could I upcoming lines the discussion should the we’re be at And VORI? for Phase time at know as X. was like for It we of to a should registration whether what some the be forward X approval? seems to

Glenn Mattes

that we X Yes. need We’ve for actually to and were said some Michael, transplants. TAC going always Phase lung data

on for recruit the won’t So, will we’re some in a the or and the is we’re looking Phase we’re tacrolimus. again, the start as look it us going getting never work VORI And yes, finding protocol yes depend doing from rapporteurs starting as FDA And that’s way Phase Europe minimize that distract for no. well at to to the VORI going that patients the process amount the the is, And the we’re going hoping the we about of of data, to to the input FDA before it. from tell we’re you It data. the partner we program the X in program from we’re taking. the finally on information X. depends get It’s position

approval. the into get trial the Dale, it. allow data. depends the end And that will I for the on that? am on quarter again, believe next I use I’ll us hopeful we answer were about So, the same queue that to that FDA to It year. give midyear will third correct will

Dr. Dale Christensen

You’re correct, Glenn.

Glenn Mattes

So, normal then that normal at accelerated -- either review point. a

Operator

come next Richard questions of Deutsch National line from with Securities. Our the

Richard Deutsch

call getting and today. my me presentation Dr. is Williams. This taking my PhD the for for you Thank Yes. along way for

that follow-up. one one to limit of it still at, than I stability, other monoclonal with mentioned antibodies for You working that? you had was stability XX the I that ongoing were I able And longer weeks. open then recall the that maintain stability Was think, is have or it

Dr. Bill Williams

Yes.

weeks which studying centigrade, was That we’re And particular still that Richard, have harsh of XX do it conditions. ongoing. XX that extremely stability. is still is antibodies, on degrees So we still

Richard Deutsch

quite Thank the be extend you. expected bit use to powder able other ultimately inhalation? can on is, be ventilators your longer. can patients a it And So, question to

Dr. Bill Williams

Dale, I’m you that. going to let answer

Dr. Dale Christensen

Thanks, Bill. Okay.

through device -- currently, is approved So existing there dry to deliver endotracheal approval is by as a with the an no device tube. FDA powders that

intubated, treating they So, early get actually they patients get to that they our and the intent get to that before point. is hospital we’re them the treat would so before clinically before to

Glenn Mattes

that, Okay. don’t the With questions queue. I in see other any

first have call. we we in patient one, we of came Phase did the So, this in X to today. dose actually I do want that news actually report niclosamide two pieces Number were while trial that having

scheduled done So, very announce Day who the And Carsten Time X:XX now, should to be trial CEO right it’s about early Chris Emig, with p.m. that’s voriconazole conclude XXXX. a XXth headline. will talk the program. for on are the is Eastern of Schwartz of and That the time. I who recruitment Augmenta believe Dr. part and We’ll our we TFF going have of second December. Science

in you I Thank all great you, awful And length, good for as a Again, I for and an thank know, this to but wish of evening. health follow-up. holiday want So you like to to all a with always and had for participating the would I communicate. season. lot that, I’m apologize you accessible we call.

Operator

appreciate does This We your conclude participation. teleconference. today’s

You Have a this day. may great at disconnect time. your lines

TFF Pharmaceuticals (TFFP) 16 Nov 212021 Q3 Earnings call transcript