- Earnings call transcript Q3 2022

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Operator

Welcome everyone, to the Fresh Tracks Therapeutics Third Quarter 2022 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the call over to Garth Russell from LifeSci Advisors. Garth?

Garth Russell

Thank you, and good afternoon, everyone.

call Andy Tracks' Bert Sklawer; Medical Dr. today's Rob Executive Marchio; on Officer, President, Brown; Chief me are Chief Fresh Officer, Chief Joining Financial Officer, Chadha. Officer Operating Monica and Chief R&D Officer, Luchi; Deepak Chief

reflect this these Before we begin, statements opinions about of and results would our could like are statements differ. forward-looking subject will forward-looking note company. and to conference uncertainties cause of everyone contain that as to webcast the the call call. remind this I statements that that These to Please only risks actual date

or We to most release those now expressed will to not Rob, light our periodic filed future on undertake discussed in is Executive obligation is It by statements cause reports detail implied Brown. to forward-looking or the Officer, that over company's results to Rob yours. Forms Chief floor of revisions outcomes forward-looking to XX-K other revise with actual any XX-Q Factors on materially greater information statements or recent and X-K turn the my are or publicly and SEC. events. differ of our from in call such new the the filings in pleasure these the could Form results

Robert Brown

rebranding Thanks, Fresh corporate and these a name were is this our We of a of past and along company in summer, fundamental the we've introduction Garth. NCEs, and of a developing by Phase currently of actions the shift to is These Good novel science-driven included first-in-class meaningful our and we thank the shift Therapeutics, of in Driving This promising new of and year our website FRTX highlight afternoon, formerly the patients' trial, -- being programs which that joining changes mechanisms call with BBI-XX, brand. first paradigms DYRKXA I could clinical mission by shareholders. inhibitor since is treatment BBI-XX, trial, corporate and today. our highlighted inflammatory targeting potentially made everyone, diseases. kinase for wide logo, this potential a that formerly believe inhibitors. acquisitions pipeline evaluated represents rebranding Phase you FRTX-XX, I for new autoimmune for value platform completed the This our over quarterly of array strategy. Tracks clinical while update generating a next-generation a the our targeted, lives inhibitor novel a commitment first-in-class therapies transform STING treatment FRTX-XX,

progress cohorts or of to Phase to completion track the FRTX-XX. Single During part and initiation of of Ascending MAD the line Multiple and on Currently, trial S-A-D, results of part Dose, Ascending we or M-A-D includes the remain continued study. quarter, I clinical SAD MAD SAD third study This the by the top all we XXXX. report of of the Dose, early

As patients administered marks study this intended a humans. diseases first the in time inhibitor a been orally with reminder, autoimmune has DYRKXA for

preclinical development in Phase with as for which lead year. this study, In development activities to we STING advance inhibitor for non-clinical addition, parallel as we the our the acquired candidate program FRTX-XX, is ongoing I that FRTX-XX earlier well continue

this a I'd to or SB sold for provide bromide past update which Finally, sofpironium on we brief to like Botanix short, May.

the recently gel, FDA. SB new Botanix was NDA, a XX% As in for announced or application, drug September to submitted

We are to share progress. excited this

gel. regarding payments as additional tiered sharing to become terms We of receive to of single earn-out they net our of Fresh reminder, to this SB sales-based high mid-teen milestone is forward payments from Botanix, as available. as sale a digits under sales on eligible updates well any regulatory the ranging to and As various Tracks SB program look digits

Monica? update pass on Monica development to Now over an provide to ongoing it I'll activities. our pipeline

Monica Luchi

We've everyone. productive first XXXX, afternoon, third half good this built quarter the the had year. and which momentum of Rob, of a from on very Thanks,

initiated to quarter, is mentioned, and just or a second are orally dermatitis capsules both randomized, and Rob designed placebo-controlled inhibitor. pharmacodynamics FRTX-XX, the continuing of the volunteers tolerability, atopic for highly This progress double-blind, bioavailable the clinical during FRTX-XX and DYRKXA to potent, study As AD safety, pharmacokinetics with healthy selective we evaluate trial short. Phase of in and I subjects

our a the volunteers the treat believe study, systems center that's a of preclinical the of has SAD on this been on package XB reminder, MAD severe based which initiate parts XX a study, of FRTX-XX This as a study the which a by innate preliminary could the serve for SAD placebo healthy of robust diseases. XA results Part part subjects potential strategy promising daily to the of the patients in a FRTX-XX we moderate treatment of days FRTX-XX SAD FRTX-XX has which these efficacy, both we study, which over dual diseases. treatment volunteers. paradigm will validation X September, assessment for to dermatitis initiated top study, compound Phase study once include each the of in immune assessment of a across subjects initial reporting the We Part in X for assessment, the After the in and and of days develop of profile is to to completed, healthy dosing. model capsules intend we a XX the Part represent next MAD and of currently an of cohorts, FRTX-XX XX compare adaptive been to part broader the FRTX-XX from placebo immune-mediated a included up I approximately will enrolled expected of action of at early of inflammatory disease. of to which the mode atopic line completing SAD XX with is This single way autoimmune of X observed fits and look which the year. placebo. of modulating program, wide over XX Based this that data total the X design with As to the with considering receiving debilitating MAD dose and and we study, FRTX's the the in part scientifically shift or X observed to forward both range date, and study receiving is administered

of and pharmacology STING inhibitor. profile. reduction in inhibitor to STING which and potent our in resulting strong novel, toxicology initial significant key mechanism, and a bioavailable pro-inflammatory Turning safety program, has is a FRTX-XX, FRTX-XX proof pharmacokinetic shown cytokines orally favorable

studies to TTK briefly touch support also activities our chemical like preclinical advance inhibitors, thereafter. I'd that continue library the program kinases. We to IND-enabling hundreds development to CLK next-generation includes inhibit on kinase LRRKX, and for new of DYRKX, entities of this starting which

with of more high-impact some We're both kinases programs and and one non-brain autoimmune, from and potential as for promising brain Importantly, spaces. in rare designed of or disease penetrant treatment numerous debilitating the neuroinflammatory, models different optimize to penetrant the inhibiting has inhibitors these of identify, these within outcomes the platform range goal characterize oncology to within mimic novel shown a conditions planning field. progressing of kinase this diseases

Scientific like immunology of and hands-on Kate call over with Khor, Doctors fields Nigrovic, and to which the of SAB, scientists to in This of the Advisory consists X Fitzgerald, our Lee, Bert Bridget hand experience the Board, information I'd of decades Wagner. inflammation. I highlight financials, or review and the Peter includes recent Bernard Before to clinicians Pui

pass develop as team We guidance we call overview a are the of to will honored leaders I'd to invaluable Bert to and financial this whose input newly to quarter. be of Bert? thought therapies. pipeline to for our our the welcome world-renowned differentiated established like over SAB now provide novel

Albert Marchio

on Thanks, the Monica, to and day good everyone call.

filed financial I read September the the our in Starting through on Investors of want the SEC. XX-Q, to summary third as XXXX. consolidated website quarter of XX, report a $XX.X and reported our provide encourage statements full cash accessed be section to results, and cash Form once company equivalents I the our cash, which MD&A XXXX million in Before of financial contained you with can with

consisted turn gel, ECCLOCK, from APA decrease which for primarily and of least last the under the FRTX-XX. loss of and G&A sublicense third cash from expense quarter expenses income third the to regulatory the quarter for X% partially was license compared million up costs of expenses primarily combined agreement of services million of to other of equivalents, $X the quarter related third fund lower for the the $X.X to of driven R&D near-term and million royalty cash quarter period compared for consisted expenses connection and with Botanix and sufficient our with related contract same The 'XX revenue administrative increased the year license third quarter for TSA consulting for of or third remarks. for the Rob? decrease by prior to year, $XX.X the compared were This with expected Voronoi quarter fees quarter recognized under this for fees, Botanix million be same third of third million compensation payments We Pharmaceutical. that quarter agreement $X.X clinical $X.X the to company's Inc., with compliance the SB the with operations $X expenses includes expect under million. Revenue the $X asset I'll for XX encouraging TSA, offset or purchase compared our the net of fees. 'XX year $X.X of for $X.X back that, Japan approximately third agreement call to lower with million which the $X.X million Revenue for was million of Rob revenue by for in we was at last by months. to to for the $XX.X recognized million 'XX upfront transition provided the of next and prior Kaken to over clinical year. Botanix, was quarter for the Revenue sales closing to year. the million APA 'XX. APA company the under And lower or SB, were services the will

Robert Brown

recap, Bert. financial the for Thanks

of with inflammation. assessment this the potential the We the advancement novel first X -- exciting months pleased of within and pipeline therapies. forward to of broad has much-needed and believe XXXX, we field pipeline are of treatments continuing to produce the progress We look immunology over our

I announced prepared the I'll remarks. XXXX to are for now there STING in expect call, and highlighted on As is Operator? other over remain continued development SAD/MAD our important significant opportunities inhibitor the FRTX-XX few open occur to top our Phase track to create novel concludes the several the shareholders. we notably of ask from therapeutic which be believe early we've quarters, present today's milestones next up our by to results the lead study, candidates, the covered This ongoing line we on This which the for FRTX-XX. call questions. operator value

Operator

[Operator Instructions] Lugo first Tim William question from of is Our Blair.

Tim Lugo

the on Congratulations progress.

of discuss patients, but entering of you the AD FRTX-XX to they've assume moderate you how going therapies us For be prior of the that I trial? the Part be? biologic-naive of will kind in been can a X sense to are to patients kind these exposed trial, which can give pretreated the

Robert Brown

over Tim, one you? that the Monica, Sure. Thanks, for question. why I turn don't to

Monica Luchi

making Sure. of we're Tim, X dupilumab study. received as who months the requirements for have to for prior patients period biologics not actually, entering a such

participating not previous the of that does a the the far there's previous their continued drug. I exclude this at sure beyond of them Phase But study. any to that least activity piece make not for biologic, uses no part study, it's for So Part X -- of we'll sure in make half-life

Tim Lugo

inhibitors And or any around JAK an these inhibitor probably be thoughts as patients? exclusion naive will JAK

Robert Brown

naive advance. but inhibitor to exclusion an do have prohibited These will JAK they most patients, for which period in be we be the likely would

Tim Lugo

development development kind the just or of you great. can partner long data, obviously, in a continue discuss you when want X lead the seek question, do business ideal thoughts to your partner? -- time of Okay, novel around of And to a a but when proof-of-concept assets maybe Rob, without kind broader opinion, want kind some of how your both you of

Robert Brown

We We Yes, more a to about. art when on certainty you regular than question, both Tim. these do ever to parties. as obviously, We an good And we Obviously, DYRKXA. we'd good we people those. since talking with information inhibitor really are out the to also acquired listen we do requests Obviously, get to have data things. talk STING the of as like can well investors. share the it's to

kind of using there know So But is approach a I multi-pronged we're ideal an time. if here. don't

that as drug on I data position of think time. drug, the it's at a company's the combination the well you the as have

Tim Lugo

There's the you're maybe giving in that significantly I partnership, upfront by you these been these the development past terms of what maybe than market assume major even of obviously a market approached kind dislocation when to a companies year. over be days? Can and larger you could is speak

Robert Brown

Yes.

forward. and more it's on why of mechanism and curious with not platforms interested intriguing kind curiosity actually. lots to have because, excited we people, of acquired probably have speak to a and approached that really that. medium like we we're to in think, their curious move the that us don't as therefore, encouraged the it have small, what see we obviously, is they're are that their being deal of mechanism and appropriate one We and and it to companies don't these I in interest data large, look to to understand announce certainly, and I the are But speak we're ready about might both first-in-class by want DYRKXA

Operator

Our Lake Thomas next Flaten Capital. is Street from question of

Thomas Flaten

prior do it back you have what you at? think platform-type assets to basis? a I by more don't the know be how around license Kind so done, will you've can Or trying of compound guess, much compound partnership, deal? ability get to the I a to of I'm that's on DYRK you enough work questions do that differentiate

Robert Brown

be in to blood-brain from some penetration. need may products that I barrier our out there broad it acquired, right, -- want for don't. at are blood-brain And is. that those type research not kind Alzheimer's there I'm least of assets of belief we that Yes. have like think of of on there that the is, opportunities the for disease, disease that this Certainly, barrier library I partnership that's there Thomas, otherwise. on these in versus mean, that sure where DYRKXA, what a depends, it cross you you'd those example,

that you So this products where -- the there's we also do in how in see families where They've developed. able also of to originally break terms different -- be might these up. involved are were the

different and offering. do they're they party, are be on the So It interested a to there ways certainly couple of all what what could we might depends that. choose in

Thomas Flaten

this thinking you're thought through a how hypothetical. those are about I just something guys is in the and you're -- the to collecting could value-based for of you then recognition is that on and -- bit when response how I'm are just thinking used or curious And from into the for biomarkers, way biomarkers of given already a competitive are study. guys factoring hypothetical But market AD I'm is, be all crowded kind you ongoing about example, about because a the contracting. process how comprehensive that curious you studies how that thinking realize

Robert Brown

go. going and one just with study It's although impacting where is, Yes. isn't that how things understand first there, A drug said couple remember, that this of understand always useful treatment to autoimmune necessarily the it's diseases. in do we're to important it someone really AD, going in it's we've to patients we're a

it able So -- It read And skin, in dermatitis to Phase because we that us be to we in that in think so will we see where be AD. we'll X do it's it's going go in it's easier atopic patient. weeks, in easier lot that decide isn't awful be that. II. we'll first X leads have to be able also potentially information to efficacy to All what weeks that certain an

also have that other So we're of broader looking the so are autoimmune an potential we biomarkers for understanding can diseases.

a message. ability that little of view, their a one for early of value terms it's of payer a terms in In from point

one for that leave rest now. we'll So to

Thomas Flaten

But to you'd anything to that else summary? superficial like Monica, there was my add

Monica Luchi

No.

believe point, and that disease. think want I of within at pretty was just we to that from we're on this Again, these that study. we'll ourselves biomarkers. some accurate. markers I Obviously, at be stress of to have see depends we're the going looking a for is engaging X-week assuring markers looking it engagement target this what we also the At

efficacy is going of because So assessment it of limited. preliminary there be to time the allowed. that said We've is intentionally

to these period, short be in some have able biomarkers to study. still study within them the So information will provide of will of this next some

it's So as going evolution in move to be think forward. I we

Thomas Flaten

you. Thank

Operator

to have We floor Please I questions like the over sir. Brown further time. no would Robert to comments. closing turn at this back go ahead, for

Robert Brown

updates about as for Thanks biotech what for the Fresh and suffering progress to taking We're to additional the sharing enthused for update. look holds debilitating inflammatory afternoon development time listen Tracks forward to a moving forward. conditions. cutting-edge exploring patients from treatment on autoimmune alternatives We our future our this

free you day. Have a out to As have reach great further if feel to time us always, any questions.

Operator

today's for That conference. us. concludes Thank you joining

may lines. disconnect You your now

Fresh Tracks Therapeutics (FRTX) 13 Nov 222022 Q3 Earnings call transcript