TFFP - Earnings call transcript Q3 2020 | TFF Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, ladies and gentlemen and welcome to the TFF Pharmaceuticals’ Third Quarter 2020 Financial Results. I would now like to turn the call over to your host, Mr. Paul Sagan of TFF Pharmaceuticals, Investor Relations.

You may begin your conference.

Paul Sagan

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

Glenn Mattes

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

an progress. Officer, will our I call, on clinical update his to Coleman Kirk our corporate and financials. ask the review will During company’s I then Chief provide And Financial

We applying technology Dr. progress from company. are Texas questions. for Chief in University of then the then Film Thin will And Bill Austin, lines vaccines some we have are us who the happy Chris the operational we Officer at biologics. the exciting update talk making Williams and to of about also drugs, Freezing will up your Cano, Operating our And to Development and of Head for initiatives will our open Business and on development business

more for with Felix will active most shortly. Augmenta yet from have platform. Film quarter, I dual-track press recently capability agreements: first, potential and in we that demonstrate another and the continue model with validate detail productive you strategic discuss have two the making technological today, seen and want we our progress significant afternoon’s had the to to As these and business have clinical Freezing are Thin with developments two continued I this importantly, very you culminating our company emphasize established and deals these Biotechnology. this the week two Bioworks, with enormously market programs releases, But of

We significant dry Ross our of ongoing for ensuring have powder with the successfully inhalation the University Dr. working Georgia with to made virologist, work the have renowned for progress vaccine we potential flu a formulations. liquid first in a into also Ted equivalent advocacy reformulated universal time

maintained due COVID strong three clinical Our an environment the momentum extremely have to internal programs challenging development despite pandemic.

outcomes. for level healthy the blood the enter first will of demonstrating Phase trials. Our lead direct-to-lung subjects Inhalation X Phase in dry X and results These outstanding, Pulmonary X Phase ever clinical successfully powder of Voriconazole clinical safety Invasive and Powder, study dosing were program, Aspergillosis formulation the completed study from treatment

important include belief a beyond agent Our no immunosuppressive second heart, transplant substantial patients liver drug These clinical demonstrated events Powder, Inhalation and blood give trial have that an associated trial strong the for achieved program, significant clinically ultimately treatment will kidney transplant immunosuppressive in TFF us of lung potential a Tacrolimus Phase X has to significant has results procedures. lung its transplant and Tacrolimus adverse rejection levels.

patients. study in survival potential niclosamide cohort We to on also And are advantage PFF schedule. is examining trials think Tacrolimus, there transplant first-in-human a on

well. tests. time proceeding to been some quite intermediary product now line, working between their partnership the testing Finally, company positive PLUS reactions production PLUS a Products our has is concept and from updating Products is with consumers for

dry powder This our products help us CROs one under third secure gives Freezing develop responding for and currently to of products. quarter premier our capacity assessment. the expansion took we partners, pharmaceutical and inhalation expand the our manufacturing choice needs company important of to a produce with During steps our Thin Film to

progress We using capacity effect to antiviral other Austin further work repurposing University our to team Film Freezing of Texas have report his Williams the COVID-XX. at their Thin its to at and continue techniques broad-spectrum the an enhance in other plans agent existing Dr. locations. in at and expand in lacosamide,

up we develop allows capabilities. technology wide capacity creating So, and a briefly, potential opportunities have compounds. us. partners to we are our of of recognizing variety and sum remarkable investigate, rapidly world is this believe And prototype, to a market for us and unique that a The

at antibodies to biologic to two speak represent the And The monoclonal week’s two Felix and to like in call. this that it’s Williams Dr. door and our other these partnering look complex Freezing open will Biotechnology was new with important respectively. and the in exciting platform time intensive. to Bill succeed these potential developments later Thin note compounds collaborations modalities. drug So Augmenta But a these platform technology Film take now delivery Bioworks breakthrough for and developments. our this bacteriophages I needed would in potential closer applications effort in for important

incorporate two patients. botanical development to can delivery We from with products Looking Freezing at of we agreement a and and for of private placement agreement COVID-XX. agreed successful dry the add Tacrolimus our joint commercial looking lungs storage very impacts development same inhalation monoclonal potentially than XX:XX forward all our both worldwide after to And a Augmenta had programs. first and of Freezing antibodies to to products Augmenta said products this administration, both these the Thin dry Thin of the is development human-derived develop antibody product formulations antibodies revenues, with are where development indications agreement will includes the have technology for formulations and agreed Bioworks, costs portfolio. manufacture Augmenta’s would reconstituted, that chain future to utilizing specific to formulations directly to agreement of potential develop have other for be for a collaboration of XX:XX These joint powder our along the The we therapies that our split monoclonal the parenteral our cash developing payments fourth for be also This also companies sales additional Film COVID-XX and the and companies developed internal antibodies we companies powder cold Film handling. synergistic third-party. option Both resulting a of have payments the project these cash our monoclonal split of or related all to mitigating is a to Voriconazole, license a therapeutics.

of are edge is in We therapies. relationship bacteriophage prospects our Felix with field the developing firm Biotechnology. about leading excited on of very new This also the the

Biotechnology’s to completion parties to the subject this Felix to agreed exchange in in biotherapeutic collaboration, million. note $XXX the of employ technology, upfront license the Felix a conclude is Felix payments successful net Intent under have will a milestone royalties sign non-exclusive principle of the entered that provide technology. shortly the mutual technology Thin the into inhaled Letter the definitive commercial to of negotiate proposed development for A delivery total and worldwide and we could conditions, with Freezing to lungs of agreement We Felix The also eventual for bacteriophage-based including eventual would and have non-binding on which TFF of and of payments to a They our Felix, license pursuant sales develop of directly parties royalties patients. payments, And in to stage the license Series with the agreement, development to a hope which a agreement important It number exclusive financing. of a our products. up of is Film

therapeutics. the financials. opens the door up now, for for like And excited the this again, We deal. for growing turn prospects are in our applications over it And about and of call very would phage the of Coleman review to to Kirk I exciting a field future

Kirk Coleman

much, Thank Glenn. you very

research XXXX the same for $X.X of in believe for September in company of X a were compared candidate. X the includes months certain in increase in our expenses formulations same $X.X same The The analysis the reported X-month the XXXX. to have administrative average and research for due XXXX. compared following million period outstanding the potential XXXX. basic million research The XXXX. activities XXXX, in X.X development months to to period XXXX for of in drugs period XX, become XXXX months net XXXX. with million of compared for million $X.X dry shares ramp was of $X.X and loss expenses for diluted loss to General Weighted a net company ended and were product $X.X million and development XX, October XX,XXX,XXX development period were our common compared during preliminary in testing of the ended X a expenses million ramp million For the and of completion the September we up to vaccines in the the IPO up of and powder the $XX.X

assets the end equivalents. capital XXXX, and included of At total $XX.X and approximately of quarter, cash our of of XX, September liquidity $XX.X of million the cash As we million million. approximately approximately had $XX.X working

X, Securities to Commission company’s company’s up long-term As with position plans. the the and continue offerings The $XXX financial SX sheet November future balance Exchange has adequate business cash filed our company very are of and on near-term of shelf Form with strong, today, a statement registration common to of the for resources million and stock.

business that the with it’s believe we place the markets, respond turn to that capital can effective to call Glenn. registration to access arise. like future help have in that, with opportunities back should we And I they company an prudent However, so provide effectively can to to would

Glenn Mattes

the to who in we This to And work Kirk. with field inhalable technology ability platform about to the efforts turn Bill Augmenta, broad biologics where Dr. of talk Thanks, doing using will Georgia. Film now, our including I in is the into is these the call dry University our over some of powders. an our of groundbreaking Bill? unique area are Thin Williams, and Freezing reformulate Felix its want biologics,

Bill Williams

Thanks, afternoon, everyone. Glenn. Good

provides, process Thin few at level chain to discuss what the Freezing biologic process, therapeutics significant handling. I would next improve the implications worldwide on delivery high by the a does requirements minutes, of Freezing and eventual how storage Also, the of mainly our Film the eliminating it like and therapeutics Film in of cost with it and to vaccines and distribution like I in associated types facilitate cold prohibitive can these resources review the that Thin patients. would focusing to For

liquids the very freeze We that rapidly therapeutic rate. high have at developed drug contain a a technology that can

the or interfering Film non-adjuvanted. Freezing and siRNA, a We now antibodies, RNA, mRNA, plasmid variety biologics-based weight are antigenic molecular in that or drugs, have and adjuvanted benefit of types naked both even vaccines, lipid the of that low small nanoparticles, including monoclonal and and drugs RNA, water bacteriophages insoluble expanded messenger Thin greatly contained including drugs DNA, process, from more both

as us pivoting this therapeutics properties vitro with diseases physical We dry that we agents. vivo being as to for driver, have and benefit in why a and discovered and the Film that their therapeutic quick momentum studies. this both from agents maintain rapid to other this and Well, Thin have eliminate in applying search drug improve COVID-XX upon done delivery vaccines demonstrated powder And and the have broadly Freezing start developed these therapeutic many we in our the provided and and to chemical are that have are virus. this? a we systems continued technology similar How

area, has relevant So, brittle and physical providing Also, rapid It is physically can chemically key and and that injected. delivery. therapeutic extremely also in powders Freezing speed what The problems? the administration powder shared need creates happens call reconstituted matrix Film well point fully of for Film we porosity the The process a delivery. be of what other this relevant is process long-term high storage. These This solve differentiates the cold freezing. well a to powder delivery the chain the formulation suited administration highly dry to technologies at properties the storage are powder. Thin facilitate so of its and why to drug In is literally Thin to process by is dry types without a surface and a facilitates for Freezing patient dry stable Freezing of type milliseconds. our the powders easily for speed inhaler Thin delivery. other powder and thus low chemical agent words, maintains The from it useful for rapid Film powder properties suited drug all these and

conventional, gastrointestinal by is Thin An highly words, aerosolisable this powders made testing target XX% the side the lungs. drug recently in to commercially our dose For that portion better devices. by high inhalation situation, the powder as powders as Film our body, type ensure body these lungs, benefit administration and In profile is side remainder Why the be in reduce in using Film powder sites which the indicates XX%. of in to drug the effects. to Conventional for to dose available is lungs, of ultimate dry and brittle application delivery intended only peer-reviewed for Thin potential reach of deliver off-target causing in administered the dry which contrast, drug drug Freezing delivered a by In interactions. illustrate reaches to action, delivered this, published of delivery the lower the of remdesivir thus, of be the fraction of deposited be available site of and inhaler to easily used delivering the tract oral diseases drug the drug drug the by relevant? potential of the pharmaceutics, inhalation on lung deep inhalation, the also are by the paper off-target to site dry less can sites drug target the this made less and that administered this enhance safety to journal the effects. by greatly version, lungs, matrix understandable drugs can other it to for lungs delivery impact a A the the inhalable high this high drug thus drug of mean dose of treat has powder can amount reaches potentially the we must amount To while other reducing animals. to Freezing actually related to of of a drug the the lungs. target adverse the required systemic oral to An directly of disease, drug required the actually will is inhaled

and Our to be lungs levels in to high metabolite the exactly the against remdesivir exhibited dry delivery above its loading COVID-XX. its active to needs remdesivir antiviral and animals formulations powder lungs, the it had excellent in high administered activity where exert

soon made we our niclosamide we conducted addition, inhaled on studies similar will publish Freezing Thin and results. animal have Film by In our powders study

remarkable modalities be administration can back administration. or new interest delivery for powders of loaded and capability into just Thin at of reconstituted for an companies patients their be And can for drug be the it administered powders Freezing internasally Freezing form Film a or complex only point by unstable Film what But delivery who range lungs at our technology on dry powder is patient large, limited addition, wide by compounds to are extreme are reformulate well. of nebulization Thin In or the that a for about made to is that liquid inhaler injection of mechanical the Thin Film the technology Freezing to of can ventilation. to point process very truly currently, is use partners a and biologic ill is not drug that either be applied device. to It’s These these for injected potential can into our searching this effectively reconstituted as compounds. the direct biologics to

immune cells. in binds scientific and antibodies one I the As the Biotechnology mRNA, in and earlier, Augmenta Bioworks response most There the they the monoclonal the their the with antibody so antibody commonly invaders. and combined with bacteriophages. community treatment plasmid to monoclonal monoclonal promise COVID-XX, will substance. many of natural for laboratory a we currently of announcements antibodies the made extremely to biologics working made are from reformulating, as mAbs protein on are therapeutics, in particularly and siRNA, their interest the antibodies discussed are only substances the kinds that viral that is to on cancer DNA, recently including from with The in they body, that vaccines type monoclonal include of typically the high, are Monoclonal Felix system’s referred harness

routes case And powder administration. the viruses variety to Freezing antibodies monoclonal of needle-free therapeutic are delivery of relevant Biotechnology, powder and as of Film are species. different the researchers to a We to that applying formulation strains in to highly prevalence infect because antibiotics are and interest of and working for we inhalation a bacteriophages. injectable a and extreme deliver Bacteriophages alternatives are the Thin resistance dry high to scientists Felix of single specific Bacteriophages multi-drug bacterial bacteria as of both antibiotics. of dry of

it For in suggested to this infections. bacterial antibiotics can either alone is combination that be treat they reason, with used or

RNA to which other strands mRNA, complex The is molecule the include are biologics gene. a complementary of DNA single-stranded that the we reformulating large of is one that

We COVID-XX. as therapeutic with working agents mRNA are to treat

small used which the RNA is acid, as translation sometimes RNA siRNA, proteins. with is for double-stranded short-interfering of RNA to known of class again or interfering It Another stands silencing molecules. ribonucleic a it’s interfere and

delivery University of and process hemagglutinin Thin Thin was as Vaccines we plasmid a Georgia’s where for significant for We these are and After efficacy results as the collaboration studying Film affected if have efforts, on the vaccines disease immunogenicity of applied Center And universal form. to therapeutic. for our influenza disease reported Freezing we treatment studying by used vaccines, we UGA’s dry our DNA siRNA are affect recombinant Freezing with vaccines will and DNA recently in Film studied research Immunology, genetic immunization. and using powder finally,

issues addressing biologic protection formulations. infection complex elicited formulations these liquid the subsequent we that into have equivalent Film that studies twofold. these converted critically liquid Thin antibodies and to Our dry neutralizing the are product vaccines on their non-process the dry and with now virus against ongoing. vaccine We compared Freezing process powders successfully Ultimately, are powder influenza

administration, head-on formulated storage addressing of dosage second, and intranasal delivery routes chain and cold these associated injectable, when and logistics the inhalation facilitating the cost cold of form. multiple are biologic storage a requirement. Those liquid First, including as to biologics chain with

maintaining all So its Cold cold storage the and storage, and a requirement of what vaccines chain biologic testing controlled a XX temperatures be in maintained XX as administration chain temperatures and States, as cold therapeutic for or X Even product effort, This at during minus Phase low freezing United as to don’t way mRNA required countries the C to requires that degrees temperatures distribution, that COVID-XX. is temperatures These that significant patient at the the it be as example for minus degrees must that product is refrigerator to the possible. from C. address? why just this relevant vaccines must a currently less important in a storage that requires range liquid and to chain have developed to cold not infrastructure point to temperatures refers is the cold stored extreme of in distribution.

would through studies our vaccines areas. Cano, can require progress demonstrate and and that company over that call biologic thus do we that, Chief is such are Operating the these dry the in on these therapeutics, at that to not to We With Chris stable liquid temperature storage. more can chain now room turn contain continue space cold our you exciting the into convert like to forms products I Officer powder update of making who

Chris Cano

Thank afternoon you. and everyone. Bill Thanks, good

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

each great of areas. continue make key strides to We these in

idea thought examples discuss as up everyone And into I in call, few to I our we TFF. the of process, the of at a define requests questions for specific through it and share were of follow I minutes projects received making specific earnings with a the with would progress Before specific I to insights take Last process. steps. each it be BD BD BD a good we areas. these everyone walked here and clarity each few

into be it think a take our helpful walk will But time to So deeper again. through dive each. this steps everyone I

technology. we identify certain working companies such from on First, potential among would as the have partners. complex very phage, that complex a mRNA, compounds are the BD team antibodies, are These TFF monoclonal Film the Thin These compounds exercise compounds. characteristics Each of has specific benefit Freezing of targeted challenges. SiRNA, these where compounds other

CVA. activity, select or or perform the issues, to engagement to dry of directly lung, the stability Once an or educate entering exchange and/or they MTA issues, discussion perform the formulations. such require with discussion, then maybe. prepare case the an MTA, samples then to create of a For immunogenicity on then introductory we bulky the partner where formulation to perform The the and technology for discussions, confidentiality agreement aerosol the nebulizer a samples, partner partners as optimal some decision the powder example, routed receive into these facilitate dry done collaboration Statement these discussion agreement batch and knockdown partner. powder – ultimately work, testing, having enter the have to allows for the few. compounds on and proprietary do we they SoW. in some or these share are confirm to with our chain optimization introductory technology, on, We similar run utilizing for compounds. as with to work identifying transfection of material issues, cell the partner a all vitro their partners or a companies formulations, with along require just delivery culture the to Work, administration We in CVA Under reach free testing, the face of and/or deliver materials, and characterization the the the Based initial proprietary cold successes advantages transfer an ideas a a strategically and at step innovative to had our makers a an we project an awareness a able identified, into next and collaborate intention upon potential to on of out formulation we allowing the name is of TFF and to our compound results

work the be this powder or indeed the better the confirm next ability testing vivo of enter is inflection our confirmatory of evolve the vivo work TFF GLP/GMP mouse completed into the work, to manufacturing scale that on will projects. license lab like complex is The the scale immunogenicity. from and than dry I powder where spend confirmatory usually equivalent testing. are minutes compound. partner original license a is dry collaboration planning that by All would where an This critical in results and a next our to along from step this to which will both and is formulation the administered agreement. control activity the TFF. in This model, arms to and/or point to a mice, other giving It consists with is the after is few ongoing partnership requires will update

University results from TFF the Bill the the positive data As reported powder Vaccines exciting XXXX, formulations of October collaboration vaccine maintain on is the CVI Immunology, Georgia’s now that confirms Center its our high XX, This with for that development dry company very and we Glenn we animal as of potency. and have Group. a discussed, for

ferret influenza. of a strategic gold vaccine, is on the with with of CVI next study, in antigens new including from together and obtain these UGA, the the working perform funding further to UGA which Ted discussions in potential a Ross standard potential partnering to are We steps Group developing

all options time. this We at exploring are

as collaboration announcement opens was business on Augmenta. development where for November Another our with in TFF our This X, of development monoclonal antibodies agreement we we and for effort are new doors exciting collaborating joint the COVID-XX. development announced

antibody to diseases. TFF this or key monoclonal provides respiratory other additional the chance well, opportunity develop As mAbs in

excited to collaboration progress forward. very are this move project this We and

today, Felix Intent As will Biotechnology. Felix of the benefits and strengthen also earlier our a Augmenta TFF with technology treat Letter further to into reasons. mentioned, in Both respiratory to the This and Glenn we position space entering the the extremely compounds important for many validates collaboration announced phage in delivery to further diseases. TFF for of specific dry a the powder transactions directly to are formulate lung complex

strategy to both into drive transactions execute financial these testing technology These First, validate on strengthen opportunity the reflect also TFF and has development as also straight partnering. TFF that the These provide as technology the transactions can that well to enter company. its encompass flexibility transactions upside transactions products transactions, for that co-develop product TFF TFF TFF formulation for technology activity through the TFF expertise. for These our the also and works. license.

expand areas focus. into a spaces phage mAb with build to TFF collaborations into We it our category in and and both This and of to powder additional expertise dry in experience the are leader allows we concrete each And order and other critical it monoclonal in our antibodies foundation continue complex of market are formulations compounds. is building the as partners new now in to utilize will transcend to phage. technology us each and of allow

our foundation, our for drive building expanding and value will reach, enhancing are the We company which this and its technology stakeholders. strong

they powder entered top dry dry versus dry extremely company. the powder. under vitro and partner performed original samples into the their was and results are XX of pharma in Back powder partner shipped with are the Another equivalent. with the we we formulating proprietary The that results. a pleased working to liquid our testing. we are Both it solution, TFF which was the into a projects an July, siRNA MTA We their in

with top project, are their successful begin formulate. were another working initially pharma in we On which in They sent in this was proprietary We us to the are one formulating testing, challenging a of now will later We dry extremely tests, are X in company. pleased month. vitro was of vivo a vitro planning the That which they process We testing, technology will performed month. delivered in us and being next have the the performed so that TFF This completed powder compound. now version. planning the a confirmatory we particular partner of which now be were with second work and compounds.

MTA now Since have third new with numerous a spoke, fact, last we we to new we include amending our entered initial In compound. MTA are partners. into

such formulating We on monoclonal are biologics various a we VSV plasma vaccines the antibodies, mRNA, into and SiRNA, to lung. AAV, products, multiple directly for DNA, are inhalation, with proprietary bacteriophage bacteria, powder partners proprietary delivery dry TFF working as their

We for extremely this our are it Well, very excited opportunity, for I the partner, have important is and think strongest these collaborations. future thank I most valued to collaborator. potential

business our All supported efforts these at tireless at are of partners by of Austin. University the development efforts the Texas of collaboration

innovative We delivery. With our BD of drug Thin company. of of the of and back the team, the have Freezing your and the In expand a time. Williams the excited Film closing, Bill to many only from Thank Film support I we to continue opportunities the surface about his applications now the perspective, are of of hand research over applications growth areas new Glenn. Freezing into Today, believe and Dr. we you very we scratched will that technology. it technology for our Thin technology

Glenn Mattes

of pandemic, Thanks their to marketplace Bill another the very challenges produce And in remarkable Despite Kirk, This deliver to much, for our quarter team am as to efforts. TFF. progress promise and well. the I and of our continues The thanks science. so global activity of proud the responding technology. Chris, has is been of remarkable

in up questions. coming of to we updating it support our operator and of would to I we potential you open partners turn And our the further the to forward progress look like our As with to and the technology And Operator? the back the on quarters. and to investors, we as company. call that, appreciate always, our look

Operator

from comes Jonathan [Operator Instructions] Our line question the ROTH. Aschoff first with of

Please Your line is ahead. go open.

Jonathan Aschoff

for than release X would just data curious Tacrolimus results, was for still full which the interim Thank you SAD themselves data? await you why SAD Phase was of just curious, and significance rather Glenn. very much. was And have what in that? been I of X partial Phase do dosing I the

Glenn Mattes

Yes, thanks. Jonathan, question. it’s a good

that Dr. compound, data So, really the look our thinking of the that in Tacrolimus who all we results It we with are started Phase us actually fact, getting running at even indication the with line and we were Christensen of to in [indiscernible]. impressed so beyond of Dale were us potential make on the studies. that is is the X

we able So, the so have we wanted hey, events, know something to getting we starting here, look, are to significant. the be blood finishing no we off we really really levels MAD that but shortly, are special say, are we the to going adverse were be SAD,

Tacrolimus this at the which our then itself look dissolve looking asset be compound, that value has transplant And very, we you tremendous from and share. significant a find pivotal when then believe heart, transplant. anticipated. market very to think into at to potential And greater kidney even standpoint, would we strategy those partner I beyond than a the has when look Now, we originally trial. indications, has lung And liver to would

has dose we that drug directly advantages could because the efficacy that lower potential the to results similar lung the be of a Secondly, going so at positive, think survival. show for to least in

asset. we have get really and an it important So, what view thought of the we to sort information reflect expectation for was that enhanced and out an of

Jonathan Aschoff

a trial take you do it think long to how survival? would show And

Glenn Mattes

answer survival the Dale, want to question? do you

Dale Christensen

that Yes. add to And of be with more Glenn interleaving will aspect the is what are the cohorts to dosed MAD. want the to did starting of we said, the had along that MAD, release other the one I SAD thing

reached have waiting instead the And safety so start release. allows another multiple the point and was to that that the that we us a aspect of data in until of dosing end

show of advantage that to the the the shows survival of aspects time lung In the patients, aspect terms survival would really at it first and point. key X year the survival the greatest year be for transplant degree

expect where within really be that following would early full them the And it’s we first and transplant that survival, so treating start year. after subjects month would we for we on would X and year

Glenn Mattes

Thanks, Dale.

Jonathan Aschoff

more A first Dale. of question you, have all, we any can financial actually for that’s or is Felix a blanket no? Thank details just

Glenn Mattes

Jonathan, with of Well, I you structure, going we – to where do all upfronts, licenses this we doing we been have can are give meaningful the as are milestones. our

in development less sales is So royalty. compilation the milestones, at are looking the number you the upfront of

been the This formulations differentiation secure also they them that position described the done. ahead. technology in can IP the done and are some these to getting just and using quite the of that’s structure. agreed we an get gives are level haven’t are Maybe we to a So aside And move helps as the this our their time working [indiscernible] what been dollars, of great the line have had with have disclosing work, give TFF the Chris results compound, bottom of improve this high we on with confidence you these going worth. deals Felix funds where and specifics great as so quickly sort but what we

Jonathan Aschoff

the – do [indiscernible] Okay. late, what And going release, Felix I to that? what’s with what regular joined call

Glenn Mattes

Do with sorry.

Jonathan Aschoff

The inhalable phage, phage?

Glenn Mattes

you about? We a want indication. a don’t respiratory the Chris, disclosing not I I but will to talk indication, answer because are the know, it’s I question, guess little do bit

Jonathan Aschoff

as as closest for talks. best against please going on these It hard after one, sounds Film as from certainly Freezing available as you using probably you like put buying transactions. differentiate Bill, Last Could technology are you your Bill, can think few Thin competitors are for a competitors for Okay. I you how the your finger the you same quite business? from

Bill Williams

Yes, for factor that to type able the Film of enables rate matrix with we freezing differentiating these make powders. formation Freezing, I the Thin the this are powders of it’s brittle mean,

chain to can a those where matrix are to can as So, be you they step or injectable kind do the for then the of powders can reconstitution those that one an then process brittle storage argument. for lungs it’s cold delivered –

environment. cause also chain in why of these and that’s And stuff lot A sensitive will differentiating and to biologics, the they are they in They cold a essence they being pH that’s are sensitive degradation. of based. all an protein factor. are mean, I be have vibrations to to So, sorts and illiquid

viability. And a affect are or so produce and that type powder able will have their of stability we this process not to

Jonathan Aschoff

So, your something don’t properly, they dissolve the or a would is inhale closest fold function, that? as doesn’t after its there competitors maybe but make it don’t proteins like product, readily

Bill Williams

Yes.

conventional So a competing might localization. technology be

by is biological even the powder be if powder not have to get, a is very issue then you there freezing. and And slow by reconstitute administer form nebulization. So, can would that the that it’s in dry the inhalation get then you stable, the administered you powder,

shear are lot device the lot And stability itself. of energy, the a the from so affect the high And that a of get you protein. can nebulizers of

but significant for of process. also some as evaporative spray heat, that exposes shear as because biologics drying, an could during these competitor biologics the to The the be it’s well other process, shear mechanical

we mechanical so we use believe, And don’t shearing well, don’t we heat. and use

that’s differentiate. spray that’s but our – away, over we – is process are how Jonathan, drying, right So we how advantageous

Glenn Mattes

Bill Jonathan and So, thanks thanks.

a in have of lot people We the queue.

kind follow-up around of So Thanks, on one. Jonathan. one

Jonathan Aschoff

you. Thank

Operator

Thank you. And line our Mayank next B. a with question Mamtani comes of from Riley.

Your line Please open. ahead. is go

Unidentified Analyst

orall? [indiscernible] This on some the for specific kind were to talk delivery afternoon. of Can of start to first, is. of Maybe quarter these it it’s this relative questions discussed, steps already on Tacrolimus that context to all in from progress on piggybacking see heart, to of benefits the some Congrats good explore before fantastic. Tacrolimus it of with program, is you Mayank. the and Couple us. the progressing good to maybe kidney you the and of indication as inhale and other some relates that liver Hi, any

Glenn Mattes

Yes.

ready a plan We pivotal intact. point drug developing getting it’s drug the trial for the approval. doing by remains strategy marketing thinking where to the and on the So

a Our that business remains invest drug in model that resources in the to take and that and so point drug the at to terms intact. partner, of point find

they we the are to our the much drug other higher forecast were develop and the there outlook fact indications. only program. our that opportunities And mentioned is great Tacrolimus in think therefore, I However, for started than we think

for standpoint trial. results enter specific it do the So, pivotal to that that trial, will an report us and and clinical take finish analysis the with line the development the next ever interim to step from is on trial we a then

Unidentified Analyst

talk Great. of on and future, does trials agreement the you of capacity the going the can manufacturing kind really given you other on in across and And for that regards production should have clinical then and recent get kind for helpful. some recently Experic internally everything with each? you partnerships entered that programs that’s to of to enter commercial That’s then in scale both what may

Glenn Mattes

be to manufacturing the we satisfy do the opportunities contract and our Well, all constantly of at expanding have. partnerships, to able potential are prepared be looking work we to

now, on discuss, the And we right go. go when we for or – where know as we vaccines, to going partnerships. and phages So mAbs is so are strategy or CMO we example, focused we

enough place them. and So, to to intend are But put own we a a capital are potential we out bricks do and that put or haven’t our plan talking engaging there partners to in plan mortar. there capital

and all transactions future So the after. that needs we to needs of satisfy will going with capacity internal our are have we

Unidentified Analyst

squeeze in Great. for maybe can one And I then Dr. if Williams. more,

of helpful of of the kind Just or studies wanted how was are and But goes in are to to what terms that that the vivo of compares done, binding seeing it in on. hear development the understand to was of to sort talk remdesivir? process assays how kind some observed further really what you business collaboration neutralizing with on and could Augmenta you

Bill Williams

that. Dale, closer the Dale? – are antibodies, to to so you Augmenta – you monoclonal you want think Hey, on On

Dale Christensen

question, asking? Yes, exactly clarity, the answering repeat sorry. Could for were you what so just I’m you

Unidentified Analyst

Sure.

of conducted of were are neutralizing that know Just binding of to some some using formulation? monoclonal Augmenta a the kind in the what wanted antibodies assays TFF seeing you and with

Glenn Mattes

Yes.

And are dry these neutralizing we but the of different again, in clinic, to to and vivo fully neutralizing potent formulate They well. Augmenta are and a of So, testing – in will deliver different and the to generally, the working powders variety antibodies. then all are isolated with progression active a powders work has to virus. in starting of as the pseudovirus as part a assays, way number panel the progressing dry

Unidentified Analyst

questions on a Thanks great Fantastic. taking for our quarter. congrats Understood. and

Glenn Mattes

Thank you.

Operator

Research. you. with line Thank question Daniel of comes Carlson Tailwinds And our from next the

open. go is Your Please line ahead.

Daniel Carlson

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

just you the in to First shelf the undertake offerings guys question from registration future? intend do near is new any

Glenn Mattes

Yes, thanks, Daniel.

of were the guess to filing did it as able the X of the not procedural. IPO, anniversary We would so shelf I categorize so the we you that. do So, year that and registration,

enough are substantial capital a support at is you if of what now. – statements, have working lot have we that to doing we capital, However, our look we

So now right we additional funds. raise plans no have to

capital in It to be but to So should good And it business business opportunistic go gives place. to we now, is us be, the think opportunity an need sufficient I to it’s there. right support we our forward. it’s have as

Daniel Carlson

accelerated I about Thanks. you data process COVID the on guys cases approval with have been Okay. Voriconazole at that you of number excellent sort had could after the associated program, then be with your chance mean, Phase any that X That’s great. [indiscernible] Is some program? there And of looking seen. that

Glenn Mattes

you could answer Dale, that, please?

Dale Christensen

very Yes, question. good thank a It’s you.

We exactly We from in that the is talking to to how FDA both made. leaders there think optimize be or that both have certainly to study question case to space. information industry The is get the to been define and it.

industry so, and of the into to And academic KOLs with leaders the forward. that consulting we some going are look

Daniel Carlson

potential if Georgia? the vaccine shown they lot you? have the broader there. great. go this That’s And implications manufacturers, to wondering then with with success far And you the me beyond just I about Does other Are there just of them? the to you program have thanks. of the seems are to vaccine question is contact a it reaching Okay, out Georgia, am last University that in the

Chris Cano

Yes, thanks, Daniel.

not that to discuss is practice consummated. haven’t been transactions Our

doing with So both yes, UGA. the a at there new lot of the we are activity influenza is in vaccine right space, vaccine vaccines,

the talking are a programs to number of different are companies about areas. on and we technology government some We working in utilizing

conjecture, opportunities I building opportunities and and more these as those which more fall as generation. will more it’s foundation, this and data, manufacturers, will were great vaccine if But we second is and floor of second deals with point, more to think clearly strong now at you into our of first do and to deals these come. a partner potentially

Daniel Carlson

into back will jump Thanks I guys. queue. Appreciate it. Okay.

Operator

your question Thank question. from next you. the of Please your and state And company [indiscernible]. our comes [Operator name Instructions] line

Unidentified Analyst

Steve one The quarter. wonderful exciting. made we a data and such it’s when some again Congratulations on Glenn, have from see I you USAMRIID? have [indiscernible]. is is might question really progress Hello, that

Glenn Mattes

question the handle you can USAMRIID? the Chris, on

Chris Cano

And Steve you. question. the thanks Thank sure. Yes, for

So is ongoing. that work

– formulated delivered, are monoclonal have we have we the antibodies. and So we delivered

ongoing, process of vitro in is that the And in so the work VSV, formulating. we are

the get will your vitro additional question to data, the next there answer in probably immediate or programs. funding to to advance so So next those seek step some month but be would within from we

Glenn Mattes

Thanks.

Unidentified Analyst

queue Alright. then. into I get Well, back very will you thank much.

Glenn Mattes

Thank you.

Operator

from our comes line name question. question the your and you. Keith your And Gill. company Please Thank next of state

Unidentified Analyst

Doctor, technology? Congratulations, Yes, a team, Keith using is Glenn have my question get I the most voice, the the Excuse on there all but Gill, [indiscernible]. for entire Bill. phone. in you TFF excites to Dr. to and efforts. I one appreciate TFFP had your area the really that

Bill Williams

question. Thin something and said Freezing just worked to the great few explore pivot excites for useful is with What Yes, me on COVID most we have in really that is few as but it’s and COVID, to caused how us ago, biologics. I a depth, applications really years, Film biologics minutes it with

we and the me what of we excites have got that’s a geared so for question. speak. And as biologic towards Thanks resources lot

Unidentified Analyst

congratulations. Thank you and

Glenn Mattes

Thanks, Keith.

Unidentified Analyst

you. Thank

Operator

And National our Securities. from question of with next you. Thank line William the comes Morrison

Please Your ahead. open. line is go

William Morrison

or on are quarter. Hi, timelines the then guys. they that? going executing Congrats out in Thanks. Union how Therapeutics, larger And are how Quickly pharma where and come on stretched those? progress and in on on on milestones the the you the the JDAs, are all potential

Glenn Mattes

Will. Yes. Thanks. Hi,

powder. very Union the doing with taken really and both well are we So, we the have products where oral

IND and meeting pre-IND trials. get a have as into quickly can first-in-human to our going are we as We for an

over and transition testing. standpoint. the even that collaborations we kind us zone you now got formulation cross vivo So, we line. analogy to red we that zone the of got are testing we entering to able they into a from now can into things and didn’t a or And here, getting football actually once are into as over that do progressing able the still be to goal that there. to in the these on formulation like But green on, things vivo a in have to We do been working well Chris expect been frankly they really Will, companies have get they have him described,

stage on a positive on mRNA are deals all on Chris So fronts, But we that siRNA are we at really our they important to are an we of others. be and really and are approaching for of point like platform, as platform what us. very important all some are that going getting number described

sense So I very, specific into Personally the am I am are I over-deliver, just enthusiasm because very our it. address you red what frankly excited I future. maybe am here. really about on I are would to team the and about phone, rather extremely don’t of we want date, all getting can of bullish and we give under-promise not the sure Look, you the to zone, sure but you

our have as really, mid really we monoclonals. the pipeline is value close internal really partnerships. were on now I for for potential And our creation of believe internal just iceberg. incredible long-term attention the and and expand short, working paying this and to the Augmenta opportunities we tip We [indiscernible] on niclosamide these opportunities our advance execution we and the

William Morrison

Great Great. Thanks guys. work, a lot.

Operator

Stevens. And our next comes Brown question Instructions] of the from [Operator Harris you. Thank line with Russell Doug

is line Your Please open. go ahead.

Doug Russell

on first I Glenn, an congratulate company. want you and a year to thank public as amazing you Hi,

And is? is with I a how that it You I and about progressing, about is done were question think if talking you appreciate am My three of it. a have DARPA. job hell deal doing wondering we a product

Glenn Mattes

get worked takes things before finished. And the these a for that government of get and DARPA a the you T That’s a while that Yes, in we past. those have signature. have alluded to I partnerships dotting crossing with you before it to

no process, But the in that again, on are line that we come. the are we with that pretty waiting new much So signature one. will percent goal again guarantee also

gets are the near opportunity that we to in And about make done. very future. an hopefully that So able announcement

Doug Russell

you question, or with in am his I Okay. Bill talking vaccines. and still at discussions point, you know I are about dancing one were just if them? curious Gates And some other team with

Glenn Mattes

Yes.

stage, is immediate I in are we do. a a something forward can things mutual those would Gates has of there can the have And where really lot still right interest bit that interest. are of that talked nothing little now this say about I to we things. but to at frankly, the on is So makes moved offing, focused what lot we. at bandwidth discussion Gates There limited. is point, in say is lot of their so a certainly

hopefully, of So but we stay staying we will one in that, touch. are day And come touch. in something again,

Doug Russell

appreciate really I you. it. Thank

Operator

Q&A over Thank conference you. would Glenn today’s does Mattes this back And our session I for the And to conference. like for to turn remarks. further conclude any

Glenn Mattes

Yes, answer get I questions. am sorry, if we didn’t to your

please You all do the of if company here touch thanking work know the amazing that. you how all for are conclude have questions, do And just an job. and me. want again to all also get to by that people in you support the I with doing

It the We for great a year, are excited. beginning only really it’s us. has but been

year this actually getting So, stay I and would are we the believe holiday ask of to well you please season. all hard to in XXXX but into

all in of first holidays the happy of way. very one positive to I season. we enjoy hope to want to a wish be and the So, you all a get holiday I healthy

if So, questions have me please and to Bye. well, happy and call enjoy healthy. stay any and you want

Operator

great you does participating program for in you disconnect. conference. thank may gentlemen, have the and Ladies This conclude and today’s all a Everyone day.

TFF Pharmaceuticals (TFFP) 9 Nov 202020 Q3 Earnings call transcript