Athira Pharma (ATHA) 24 Mar 222021 Q4 Earnings call transcript

00:05 Welcome to Athira Pharma’s Conference Call to discuss its Full-Year 2021 Financial Results and Business Update. At this time, all participants are in a listen-only mode.

Following the conclusion of the prepared remarks, we will conduct a question-and-answer session and instructions will follow at that time. This conference call is being recorded today, March 24, 2022. 00:28 I would like to turn the conference call over to Julie Rathbun, Head of Investor and Public Relations at Athira Pharma.

operator. you, Thank XX:XX

of of this clinical financial and research trials financial updates. results and are the safety results include be trials including risks statements commercial numerous may the time to regulatory are remind Investors filings. candidate, development release and close and begin, anticipated Before described proprietary SEC to of clinical of program, issued our IND IND product clinical like a clinical regulators, management I'd which and for submissions This presentation potential our initiation of today anticipated will interactions full-year our the clinical can to section the to activities, candidates, control, of on and ability XX:XX the future subject our in and or XXXX and results preclinical risks the successfully success many from time uncertainties, our statements Forward-looking beyond trial publication, trials timing our of with that and enrollment about found website. clinical from operations, development and the development our which of and the the potential data. XX:XX of the profile, and market our efficacy timing future product results we plans, timing statements, of designs, timing of during uncertainties the equivalent the future and US you timing timelines addressable we press of our call plans efficacy, potential development Following recent forward-looking business make market, in develop our

statements Athira XX:XX under relation from to and results may these Chief Athira’s of today's required Officer; call, on Athira’s Chief obligation update is Litton, Glenna Ph.D., Moebius unless Athira’s Research. actual Chief conform we On Operating Executive future differ to Kevin Lenington, results Ph.D., Athira’s projected Officer; Hans those regarding President the statements today's by Vice are MD, Our Medical Athira’s in law. Mark not or Ph.D., any Financial materially Officer; and Church by Mileson, Officer; Executive Rachel joined Chief call. President

will now the your call remarks, call Mark to over Dr. open turn the Litton. XX:XX I'll we to questions. prepared Following

XX:XX Thanks, for Julie. number joining this with progress an all a start gotten And XXXX off us thank of programs. has clinical you our exciting afternoon. key across to

and efforts. Phase and the Our Year achievements Pickering, across talented all to CNS leader date, two throughout considerable pursue the of our with commercialization of evidence first to drug XXXX, years program to for clinical development Panzara, leaders supporting neuronal are results progress, of the our neurodegeneration than more the ATH-XXXX. we results of to and sciences these in an been Board laid strategy innovative highlighted dosing our forward X and the groundwork publication XX the study including X enrollment our experience the us considerable experience health fosgo of of bodies. lead completion expanded our the slowing industry of looking corporate has Parkinson's The our of our across with development. we veteran our disease candidate In Dr. New and ACT-AD the with Lewy clinical industry XX:XX restoring Grant and with To addition clinical Directors oral preclinical of and approach of Phase proven novel fosgo Michael addition stages a corporate peer fosgonimeton of life reviewed dementia first and fosgo and patient or with dementia by X study presentation in Phase XX:XX

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XX:XX that Mark introduction. Thank you for generous

years on mechanistic there attention to transgenic disease development far Alzheimer’s stage follow this trying the research symptomatic as by At approach for of spent pre-dementia less As holy namely and in effects achieve disease that alteration, antibodies models Alzheimer’s in was humans, to XX:XX many to step. XX past This and a order Alzheimer’s us approach seen of requires Athira early replicate we focuses know undertaken disease mild rather stage treat stage were have disease the into a you monoclonal of search first modification. in animal the does but moderate to disease. to grail novel not

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Secondary clinical endpoints and a functional ADAS-CogXX, of ACT-AD of ADCS-ADLXX, measure measure change measure in a cognition, abilities. of include the ADCS-CGIC, global

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of reduction resulting [indiscernible] pharmacodynamics HGF/MET function study blood fosgo. in enrollment targeting drug published peer-reviewed enhanced Phase well data potential summarize, To on of of in quarter placebo treatment in Xa/b we The neurotrophic body large XXXX, the LIFT-AD in wide the of half from disease The and pro from encouraging cognitives recently significant is support preclinical suggest anticipate completing dose disease. the results range statistically Alzheimer’s may ERP XXXX. in XX:XX the third clinical of penetration. be the barrier evidence suggestive There fosgo synaptic forward, and Alzheimer’s a cohort Moving active the growing a across PXXX brain human in tolerated versus journal fosgo of ultimately and system. of was of in a latency the first topline of linear

adverse measure of about XX% would functional to see of the Second, largely treatment-emergent these trial Annual of one which initial expect due Phase to at a of XX:XX this is speed. working Xb the Finally, to processing to last the baseline demonstrate well-balanced ERP appropriate week demographics population PXXX, replicate population type findings in discontinuations AD/PD ACT-AD presented on events. Meeting XX% memory

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In promote which medical distinct advancing compound of showed addition this motor approved an including in results recent are the Meeting address depression-like ability only efficacy, another non-motor to Parkinson's indications MET need on and including (ph). [scales] preclinical demonstrated one from of and activation, ATH-XXXX, area dementia, develop at pathways compelling our to patients vitro activation an downstream fosgo, we hallmark high expanding market. Secondary group and were is augment for the endpoints drug of ATH-XXXX with disease and discovery for Annual models XX:XX Since electroencephalography presented American signaling the Society its in normalize animal behaviors that in Neurotherapeutics Experimental schizophrenia. most vivo

dosing summary, our development will the for Phase need. for that pharmacology January, both in overview, time, new is In X years is the turn shareholder And imminent. that believe diverse a underway XX:XX We now FDA no and to Following the target patients subject indication first the in clearance a of ATH-XXXX With of provide the investigational will Athira stages. is me clinical application terms in our call in the work create with trial ahead Mark. drug pursuing human and study into pipeline, publication and value. translate development hopefully XX:XX at for back let will data bolus in same the of new that presentation medicines with

clinical for that programs. Hans Thanks, our XX:XX review detailed of

a Given success statistical like data study, from our success. on so what primary frequently topline ACT-AD? be asked, we achieving significance are closely we endpoint Obviously, does are X how to the still would Phase PXXX look for

we some a and not will our powered Phase towards this significance clinical X benefit said, that see some in trends see functional in to as statistical cognitive in we study. a further endpoints. these clinical outcome confidence say we would and endpoints, are show favorable win. LIFT-AD should was XX:XX addition, big our see also trends, hopeful thesis We secondary of because the support That as key would we our corroborate trends this that study In in

this in and is lasted We memory Our goal with patients This to patients what with to mild want and most critical rapid diseases independents. most to benefit tangible, fosgo rate suffering is to -- neurodegenerative our where to and with the moderate clinical the patients bring seen these approach. a provide novel and improvement is for important cognitive lasting patients to provide improvements them, extended with important as accounts patients, marketed is help most segment cognitive XX:XX need currently can our and approach is mild-to-moderate the drugs. nearly XX% fill HGF/MET believe real we XX% are behavioral is in and dramatically. declines all of It also There AD on innovation void. for Alzheimer’s this of unique space of

to noted, data access. market closer Currently, population market to number XX:XX a the spent of we which have of only are improvement. year, As targets there other million underscores grow suffering three next Phase options have to we move cancer by Currently are And worldwide. treat across people considerable Alzheimer's drugs is with XXXX, room for there as to options under XXX disease aging is that mild-to-moderate readout available Contrast and how and four that evaluating and multitude are treatment expected Alzheimer’s X And variety to with it drugs, dynamics. developed disease. potentially we've treatment a given considerable time million there a pivotal opportunity woefully Alzheimer’s disease XX the today.

a turn Importantly, we players our there Now more of number in given success any review lot brief is gap, a room me sector. let for this see to XX:XX the for financials. of

towards clinical advancing development with a fosgo benefit We patients continue approval, on worldwide. our overarching to invest in programs an goal to focus with

on potential deliver HGF/MET platform. in We to of the order are prudently team novel our building our

you, aware shareholders work keenly be investments the let's results. diligently resources in those good of we trust put by XX:XX our stewards look and management. financial Now, are of by financial details us our our the balancing of at disciplined to We

and the December the personnel or same expenses. related $X.X investor we XX, XXXX per diluted new planning or trial $XX.X was increased Our $X.XX XX:XX for diluted expanded a $XX.X by to of insurance, cost year compared loss expenses headcount research million increased General facilities, loss XXXX an compared for December and share the December activities, These to development were for the product for year year share XX:XX includes development basic increase per We ended increased primarily driven million for and of a compared $XX.X XX, clinical net costs. $XX.X as $XX.X it December research XX, million the quarter preclinical expanded administrative legal, and million The and ended in and ended XXXX ended the and personnel basic million relation ended were and to XXXX. were and as expense XXXX. full infrastructure year December primarily million $X.XX expenses XXXX. XX, for to year as to due had XX, net an

Rachel successful presided like cash, equivalents remind high tirelessly diseases. to our many million our as have drugs. of unique in potentially CFO. course that, $XXX.X are we thank making we Chief a patients. opportunity Officer; beyond. and a clinical and and excitement vision let's ended goals. I joined are investments the million our the energy data to puts strong of With open to development, these XX:XXBefore Operating of forward take XXXX. We call Collectively, we over at cash dedicated talented The for by Glenna in very for XX, Athira Lenington, XX:XX call with has we compared I'd of a our of approvals launches questions, is questions. In team, truly XXXX neurodegenerative look position the of our important meaningful to to operator, lead and reality and Kevin our to to who Importantly, Athira $XXX.X reshape moment that the open our want us believe Church, through Mileson, closing, This team December and as value we creating support to programs your EVP the working pursuit XX:XX Research; you up all readouts a

with question Jefferies. XX:XX line Tsai comes from of Certainly. Our first [Operator the Andrew Instructions]

all and the XX:XX updates. Thanks for good Thanks, afternoon.

of terms you're you that topline QX? one have. us the share you about you a First in endpoints in release question sharing how is thinking the on There's Can number ACT-AD. of remind just a level could high lot

you be efficacy should expecting? guess, six out curves to see much planning Thanks. what are we how we share? to months? Will I So

Andrew. XX:XX Thank you,

primary expect, will significant data to trends, And statistically is to plan PXXX. see six because to months ADAS-CogXX then statistically we're show and throughout and PXXX know, you just is significant. the So be powered show hopeful we to the for not as endpoint hopefully is ADAS-CogXX,

give plan be colors we were So, show. do upcoming conference. that to more those scientific We the -- in will color

your So the will to graphs be show over we clear things, probably not time. in

And Got harder helpful efficacy for point these show endpoints? endpoints do just for What a the drugs approved months ADL. be on mild-moderate Alzheimer’s six CGIC, reference these would it. at ADAS-Cog, XX:XX three on

Sure. XX:XX

talking we're now So, historically.

that over that. think hand answer going I to Hans I'm to on to

disease months trial been XX:XX a showing to to historically adverse, placebo would number decline two population six highly were you the mild to little benefits decline has the XX-week that In placebo point moderate is, a the placebo. on past. clients or three however, and in dependent were of the Alzheimer’s individual setting expect in there see That over that

patients XX:XX share in some this XX% are on of XX% question Okay. my I can is, then you interesting data And study acetylcholinesterase inhibitor. your on AD/PD last think update ACT-AD? to

past So that XX% done treatment-naive. old believe naturally in were I studies I naive believe, are, the probably patients. in the

XX% a on arm and if the dynamic on of the are therapy, XX% Thanks. drug does to placebo -- ADAS-Cog? combo patients how here that both affect So

XX:XX Okay.

You go Hans.

XX:XX Okay.

drug that course for So And always memory you're trials, with currently was neurons are addressed indeed reported historical smaller. will responsible that precisely Phase neurons, quite [indiscernible] number X in [indiscernible]. medication. other cholinergic traffic in the to trials correct, only key also cholinergic of that in I I remind of Phase the as it average and that believe transmitter together and subjects, areas XX%, on brain Xb naïve be we in support the are taking situation can helpful

rather as advantaged we potential see So disadvantage. that than an a do

the Thanks XX:XX for color. good. Thanks. Very all

XX:XX Thanks, Andrew.

comes the Matteis And Paul you. Thank with XX:XX from Stifel. line of next question our

for much couple detail so clarify the wanted if to might. of a Thanks I Great. I you're offering. things XX:XX

then would do scale you on here to to that, guess in to in just you just XX:XX time baseline last look to you're succeed association curiosity. right? when PXXX you using Is willing need which enough look with disclose, a the the you at I right? much Test? I cuts both is, Statistical that's you cognition assumption at at one the for not baseline you Global And I registered. have, ACT, which You ADAS-Cog thing functional data see do a you to latency? So on? is much. get hope how function, any data right, sure And did the but one alone wanted different if LIFT pre-specify ask severity still Not guess, And so of across hit baseline your When at on do which their how much be and baseline, if is that that Thanks appreciated. see number is that patients you're flexibility disease

XX:XX Yeah.

question Let me answer first. the last

difference not of specifically baseline. have looked We that in

in first you last But reminder be were then a quickly question me give the – see, plan what of us the moment that please define it additional valuable variance. allows think really I the plenty that analysis And for selection -- the and results And of ACT, time ADAS-CogXX quarter may in was will have way in well also us will have have what you have. before. we optimize entire us addition or of We for unblinded within baseline looking think plenty we on into LIFT. of ACT to in with which unblinding. very we the may that of from XX:XX that keeping which irrespective data will will is, not plus-minus to we occasion, the The defined. question the is your file size secondaries population. milliseconds that, I we sources answer co-key to we related the quarter because before And we in to is mean co-key we the been which was Group. effect two is see have statistical endpoint two X.X, of for published in XX:XX the XXX to LIFT secondary the do – same an And will plan time, the found analysis the allows the target baseline selection of second statistical time And because time and particularly usually

Yeah. in that XX:XX Mark's you need endpoint on kind remarks prepared was both cognitive the agree I'm little but more functional scales I it the that any surrounding the reason with bit a But and and would likely just why why ADAS-Cog I'm of making premise like you going only honestly sharing cleanly give sure hit just for that line, doesn't sure is, be you you're share color the sound asking top registration. yeah, And maybe can any to to functional great. is.

XX:XX Yeah. Look, I time important think good in the require keeping FDA, with the at is a totality also bit of it the philosophy And look will requires and of data. really that a the discussion. of to this

to as via scientific beyond And press think initial conference quickly the are to any said in and safety event ACT in the has to in-depth of the discuss of that such that an this was so way, And as a aiming obviously findings release, include, we context the of possible. place analysis, totality also is publication tolerability better before, course, for the data. me I which add what by let

XX:XX [Multiple that. Just right? you only That's is not going this So exploratory on to patients, just co-secondary XX [indiscernible] to for it's that remind Speakers] the endpoints. be

Totally Yeah. very Thanks understood. XX:XX much.

Paul. XX:XX Thanks,

And Corinne next line with you. from the Jenkins question our Goldman comes Thank XX:XX Sachs. of

good afternoon, Hey, XX:XX everyone.

up. one I quick follow have think I

that? taken you the study, blinded you so, there provide of terms on the have that look at ACT-AD is any data? if And can In color a

in any findings. cannot since blinded, its on of And careful is this the behind such very comment are I trial approach. still type We XX:XX

provide -- the pace XX:XX curious [indiscernible] on and enrollment good and Okay. data the think And Omicron. and LIFT, an timing enrollment announced is actually had LIFT know could expansion. widely there's then I'm if update since you I I if of then, just curious we color really used, in I’m there? maybe enrollment you any that the

by XX:XX still QX. getting Yeah. shooting in of we're -- enrollment for the end complete Corinne,

that's what for. we're So pushing

inflation you is XX:XX that will announce disclose? you won’t And that or hit you something that when

no. No,

that We enrollment. -- will we definitely we've will as completed announce

so Thank XX:XX Great. much. you

Corinne. Thanks, XX:XX

line comes from JMP And the our with Butler you. question Thank of XX:XX next Securities. Jason

for XX:XX the Hi, taking thanks questions.

cognition you're on think course Do cognition effects on -- correlation one here trends versus look time on that but you you we Just should the other show ACT. relevant impact other potential here? the cognition about between in of -- relatively think timelines not drugs, for the said to PXXX I Mark, the how graphs, the for X going just the trial. Phase there PXXX see you PXXX rapid is and

Yeah. XX:XX

me let Taking good timing. first. Right. the question So the answer about

So we're months. for looking what six happens over

So the placebo goes really, ADAS-Cog will of Z you you will ADAS-Cog of difference, and can announce months, was a we because is invite and the a to at show six just -- for XX, Hans end Y we that PXXX X, difference truly But XX important. many time. really away mentioned Hans, the do that. of to want when over effect there

ending weeks, running and XX-week but would we PXXX have weeks. expect then first after have between add anywhere visit and and XX I eight disappearing then baseline effect. that's six this two are XX:XX to really the the we escape Yeah. after wanted any trial to trials with visits XX of after weeks is placebo Well, multiple assessment in this we both, placebo and you response of that entry type potential are we ADAS-Cog why of XX

in we So know show are that in from hoping at hand looking of course, hand these of the development of all goes development ADAS-Cog replication XX, you as literature. time data, there at and the PXXX points the to

ACT trial, system making the rationale the you in impacts results And PDD changes ACT. you Could And the Thanks. potential get HGF/MET the it's patients? would remind Alzheimer's then that see trial I it. just you Trial. on of of same see you quick but and clear you that mechanistic Got results in on of any us the SHAPE maybe dysfunction the then the to a the are just do questions couple in DLB, XX:XX kind from SHAPE think what there pretty based LIFT on consider of

Yeah. XX:XX no. is answer the Look,

rationale also in latency this where Parkinson's the for So been really of are we type and mode quite indeed system. up described very different and do have situation the what dementia extension with PXXX whole a and NYCO and keeping opening neurotrophic presenting cascade dementia underlying stop of been at investigation It's have not striatal much before. in action and effect is disease has that the we it's of

is Parkinson's at benefit it So the HGF/MET population leveraging. in are that the specific what And beginning is in the theoretically disease, before positive modulation that's spreading from out system. neuronal could least we of affected

great. questions. for Thanks taking the Okay, XX:XX helpful. That's

XX:XX Thanks, Jason.

Mark turn call XX:XX Dr. Litton I'll over to back Thank any the remarks. now you. for closing

And an really taking today. the exciting Thanks looking so you time XXXX. XX:XX for much. forward Thank we're everyone to

may and conference you Ladies concludes disconnect. today's call. XX:XX participating you Thank now and for gentlemen, this