CGTX - Earnings call transcript Q4 2023 | Cognition Therapeutics, Inc.

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Operator

Hello, everyone, and welcome to Cognition Therapeutics Fourth Quarter 2023 Earnings Call. Please note that this call is being recorded.

I'd now like to hand over to our first speaker for today, Mike Moyer. Please go ahead.

Mike Moyer

good and operator, you, morning, everyone. Thank the Results Conference to Cognition Therapeutics XXXX Year-End and Quarter Call. Fourth Welcome

and With me Tony today as Officer; are website. its encourage company Lisa now on Ricciardi, report President release Form press Chief Officer. morning, detailing Officer; issued Medical which is a results. John fourth and quarter read morning's Financial and annual Chief Dr. Caggiano, XXXX This the Doyle, Chief and We year-end our press Cognition's this with available the SEC filed to everyone release on as well XX-K, Executive

this differ is during information safe the Litigation of making the on days. conference Please to In that is on through Reform addition, Actual XX forward-looking be will and harbor materially cautionary provisions due Act. including by annual certain that statements today call the statements from could or the with contained and these statements forward-looking stated discussed filings. the and those company's the under Securities website previous are listeners These note company's the for Cognition's report call, Private SEC the webcast caution release qualified statements. filings, XX-K and forward-looking archived will results its We be management business. press implied Form risks call in being covered associated uncertainties by

date of conference to after update broadcast. circumstances contains information or reflect of only live time-sensitive of that this call date this or conference the undertakes accurate the events This statements to no is Commission forward-looking any revise call. obligation as

now to would like turn to With over the Lisa Ricciardi. that, call I

Lisa Ricciardi

R&D, Officer highlights covering results Medical share then prepared Caggiano, Welcome On joined Good Therapeutics we'll and to you. Chief John Dr. of Earnings be remarks Doyle take and Conference morning, will our your Call recent to Cognition questions. the and our on progress I Head call, today's Mike, company's by weeks. and everyone. XXXX from Tony thank

diseases is central available system Cognition retina. of degenerative and of the innovative, targeting age-related focus orally nervous development the drug candidates

Our the by neurodegenerative expertise in current Receptor, cellular clinical programs built which on functions regulate our disrupted diseases. Sigma-X

drug and moderate dry for Lewy drug referred In studying leading with disease. currently bodies, being also disease to patients Our setting AMD to Alzheimer's as geographic it second atrophy is our dry and candidate Alzheimer's or in the We're dementia tested as both also clinic age-related we're -- candidate with early-stage patients AMD known. disease, in CTXXXX mild to DLB. is

molecule Receptor brain candidate developing Sigma-X is small complex ophthalmology and approach from differentiated a a both with drug penetrant, treatments unique Modulating diseases. companies the in neurodegenerative other

our Now an on update trials.

to is a trial patients of XXX XXX placebo X:X:X XXX study disease. SHINE or Our Patients mild Alzheimer's receive II were of that randomized moderate doses completed to oral of milligrams with drug. clinical CTXXXX Phase enrollment

We line X in AAIC has we patient the at and the findings Association or expect top data anticipate the completed last meeting our months mid detailed presenting after Conference summer. later Alzheimer's more International 'XX treatment,

is what treated antibody ADAS-Cog course, we an in most a intravenous from the recently X.X As in Now success XX would lecanemab consider the SHINE? results disease-modifying months. in we of infusion had difference of over measure, everyone's to forefront at therapy, consider the the mind, point which a approved question be objective participants XX

the We just X ADAS-Cog the saw living. and we SHINE, safety, XX functional ADCS battery, points neuropsych would of the changes in activities test in cognitive patients exceeded preliminary of difference SHINE the analysis XX clinically Results of similar meaningful decline a compared the to where in the the placebo in ADAS-Cog in End initial first to XX on after a our including of X-point cognitive analysis daily months. this our slowing preliminary represent scores, include XX, patients outcome.

In the of penetrant through target addition, activity engagement biological its CTXXXX brain to look biomarkers. corroborate analysis and would we

trial I at their forward NIA, Aging. Before partners would clinical and on, and this seeing CRO our to results acknowledge like moving of investigators, the full to study National the Institute support collaborators study later We our year. caregivers, of look the participants

the let common Now are no dementia currently DLB. in of our me to approved II dementia. million form people estimated the bodies, few There SHIMMER condition. options to are for this study, of affected or being Phase studied DLB, a trial making mild drugs An moderate Lewy X.X turn CTXXXX second disease most U.S.-based treatment and are by with

are from has half in CTXXXX been to toxicity more the we amyloid-beta shown co-pathology. the both have know from literature estimated than potential with and and the treat that pathogenic neurons the both protect their amyloid-beta to thus, proteins, alpha-synuclein brain. patients patients Now to oligomers of DLB population it and DLB of of has alpha-synuclein sizable

nondilutive supported Association as by the NIA led primary Miami well whose by also and Jim the of our it's being SHIMMER enrollment complete We University the Galvin, at Dr. the excellence of investigator of among centers the are was from Dementia year. as The Medicine to funding the or of trial School and top present second Body aim half Lewy patients. line data LBDA, sites enrolling in

trials population. in caregivers, the our The patient -- Again, our partners CRO clinical moderate are NIH mild discussed trial a and our thanks patients, extend to being we I've prior NIA. to investigators, run

trial or early the trial in mild subjects of XXX-patient CTXXXX cognitive disease. Phase amyloid-beta. is the in with disease impairment Alzheimer's II Our Trials the Alzheimer's study and collaboration with with adults measuring CTXXXX the or efficacy of In elevated who have a early Consortium, Clinical tolerability START is ACTC, START

enroll decision trial study allow brand on START from actively the centers site ACTC to to therapy network. collaborate activations excellence to the XXXX, for pleased in and In stable received is NIA, we on $XX this forces participants our ACTC. million the START. We support made we from recruiting very collaborators the with totaling are background and We trial now of and the within join with lecanemab and this initiated

therapy. macular in estimated Dry will dry of to advanced XX% with age-related the form in real-world and permanent combination of We degeneration. disease people opportunity to decision is to of vision geographic of up million AMD to geographic for specifically population geographic and evidence turn The AMD lead an CTXXXX atrophy. I believe progressive the estimated known the can this in loss conditions, as ophthalmic for will now CTXXXX and account provide atrophy atrophy. U.S. X our

as to dry enroll on The have is impact that XXX CTXXXX demonstrate the placebo-controlled trial a with evidence study our proteins AMD. diagnosed of clinical a may results implicated beneficial been studies treatment dry from preclinical II Now who with from from people studies, looking biomarker Alzheimer's Phase approximately have MAGNIFY measurable we this AMD with atrophy. at studies, genome-wide have in as opportunity, randomized, geographic well data, from expected

change determine Over the degeneration. and CTXXXX GA safety treatment if assessed can efficacy measures be size slow lesion as period, macular in to well will other as of

this be have become will our believe In addition, will Might be well to available, oral believe drug combination therapies. ophthalmologists assess of measures towards level to trial treatment indicate an complement is move we on and option we received. be synergistic of have our as treatment determined. effective that investigators MAGNIFY approaches, more And options added interest the of with in drug the shown participants change the We vision. visual impact

processes Beyond this manuscripts has clinical Cognition impacted been work, medical past continued Alzheimer's, our scientific trial X at insights by team scientific and our our XXXX. have dry development to active made generated disease CTXXXX XX The by evidence in year. scientists providing teams congresses efforts, presentations scientific our and in published and clinical proteins Parkinson's biological and and support AMD. medical into

of progress dementia be trials proud the unwavering we and toward for the of in value-driving we closing, our neurodegenerative CTXXXX therapies important developing made for important CTXXXX that XXXX. developing I'm paradigm for an commitment new are can diseases. We have treatment, in In milestones believe advancing part

review to turn I that, financial results. John the Doyle to our With call

John Doyle

Thank you, Lisa.

grant clinical managed offering and and continued with B. stewardship. facility Riley funding we XXXX, our programs. Securities and Cantor at-the-market officially our with execute support During We resources leveraged Fitzgerald to our to our financial

provide that the Research associated trial with and sheet research to financials XXXX, to development extending existing May personnel XXXX. concluded bolster primarily balance by XXXX. expenses public XX, costs. preclinical ended proceed to we contract were fiscal and million our research our Recently, activities manufacturing decreased XXXX. $XX.X related costs was clinical With The to expected for organizations, $XX.X million through for II for offset trials December runway the offering year a year partially now by underwritten cash higher Phase million new for and funding us $XX.X with increase compared that is the let context,

was XXXX. by headcount and compensation the for million $XX.X $XX.X Officer were higher primarily Liability related XX, expenses employee to expenses. by compared increased for equity-based ended administrative other offset increase to driven million benefits, XXXX, & insurance and General decreased partially Director year compensation, December The and and

diluted The of company year ended $X.XX million net of of from for a the $XX.X $XX.X $XX.X and $X.XX to per XXXX, basic funds a were share XXXX. million compared reported December remaining million Cash share XX, basic million. or cash XX, equivalents net per the or December loss NIA $XX.X and XXXX, total for approximately as and and diluted loss grant were

can open the the the call turn will call operator, to now I to Operator? back questions. who over

Operator

comes question from from Cantor Fitzgerald. first Charles Instructions] Duncan [Operator Our

Charles Duncan

Lisa clinically point program yes, you. mentioned progress, I be a couple And on could SHINE. and would questions team, meaningful. guess And on I a of regarding a transformational be for XXXX. agree then had with I congratulations the that year. change you the

However, that be in you meaningful the oral seeing that change that relative to compound very are clinically time, an short actually that you may given antibodies. point and I a also would a given have argue lower

update seen more patient ask on completer I rate change SHINE? you smaller guess can a for so and I And if and then it's being the in population, would possibly about us you even impactful mild

Lisa Ricciardi

alert, to not When good more question Spoiler your completed, to rate provide going is update information. to I'm SHINE. the talk Charles, completer over for Tony. to on fully we'll study you will you. I the turn

Anthony Caggiano

Yes.

they about So and lecanemab you you, this changes disease-modifying change with good look had at change. be a months, data, question, meaning folks therapy. if at And as and of seen really about less could X.X-point the Indeed, Lisa over for the is talk agree are benchmark a that And Chaz. what months. X.XX-point lot. There is the a the in it's we points there X a than current that mentioned, XX a X was lot

we're good preliminary on of results success is previously. results, our which that success there optimistic great that and based we've indeed, have short reported Now But we'll very benchmark.

are more secondary follow which We the of strengthen the those how with preponderance have would that if modest. primary. several directionally measures, that -- secondary follow those changes Obviously, measures

Charles Duncan

very Tony. the would That's ligand. population. about a noise It mechanism in greater even Sigma-X or to then mild seem thinking helpful, patient is have me And to the more signal activity may that drug

trial And to I great engaged so it you're in I'm conducting in see anticipate you not START patients to of know earlier excited but out see could progress. an with I wondering that it, fully trial? the update Alzheimer's? stage activity an that guess be even when wouldn't

Lisa Ricciardi

Chaz, this Lisa. is

no reporting consistent Your is on plan to any with or and trials, there nature. previous point ACTC is colleagues. well that taken. Tony we're of all leave START. enrollment At that not updates things And his for this I time, believe interim I interim our

communicate, -- partial it's we there's for anything is to when as there this that provide us effective let communication anything and provide you done, we'll says if not know. to now, But more found it's continue for say done progress. enrolling. to trial the So are to we'll else And

Charles Duncan

SHINE, Are what that so, Okay. any Last done on to and hop X-month back that? those remind you us they And treatment given opportunity following the with to if period, to treatment? question, patients? and an is, could sorry to continue have happens

Anthony Caggiano

We have time. at extension open-label an not do this

then So safety another after treatment, folks the for is for of months month study are X followed and completed.

Lisa Ricciardi

honest, an prohibitive company extension, for our the economics Chaz, open-label to were but a we of have do to wanted be size.

great a do. considering would that's be position we It's to something like we're so team in a look something the And question, as forward. to

Charles Duncan

good that. Hopefully, data Understood. Yes. will change

Operator

question next from from Our Jay comes Olson Oppenheimer.

Jay Olson

also, will progress. Can describe patient's release results be about And I top of had the the you plan you follow-on. the press in on or SHINE Congrats And baseline talk meeting? the you study, study? line then to SHINE that in medical characteristics how can a a the a share

Lisa Ricciardi

Tony, you. from questions. hear to these good Jay, take let you I'll

Anthony Caggiano

Obviously, have to Sure. characteristics a data, the top as have read Yes. and the study obviously, for We the AAIC it. of data soon the when set we'll is yet out then the [indiscernible] July been to The obviously, baseline out Meeting the after that's plan we we do It's full data yet. analyzed. data, timing plan. not and And line locked the is, this [indiscernible] at get year. not still read the get plan is at the but upon end roll dependent the current

Jay Olson

Great. interest you've just START a you follow-up, in about you're progress seen and the from for level talk investigators the And can as then just of activation the site making study?

Lisa Ricciardi

The that's the I the to the Yes. around these sites. your Investors always ACTC member country, absolutely sites are sick, say go. family top if sites to want are were network, Day, places you'd top

study patient oral so early active and but of at have enthusiasm. an are lot to there a my population. to for are the is progress they the number the making of don't their And head, drug of I keen opportunity top have sites, we

get perspective, it's our study, a and big enthusiasm PIs. positive study, It's enrolled study making completed. with positive. from that by to but long the looking progress fully and met So and We're a we're it's

Jay Olson

progress. the on Congrats

Lisa Ricciardi

Thanks, Jay.

Operator

Our from B. comes next Mayank question Mamtani Riley Securities. from

Mayank Mamtani

are the earlier And appreciate the on Phase this on a with cohort and breaking not you how comprehensive you moderate XX-patient patients But of for mild was the going if possibility. could follow-ups. SHINE larger ARIA? be SHINE I I study? quickly of do to comment be that Obviously, a in then cohort, out expectation in any rate have couple possible. on your mild update. study. split have II your moderate of the understanding just and Maybe And Could

Lisa Ricciardi

let take your to going I'm Tony question.

Anthony Caggiano

Yes.

first the between how their me taking first, on and breaking how change we folks, then analysis down second remind outcome their or doing our of scores that moderate So the part be the severe more and can -- you entering, impacts measures. less of will mild severe And question? and

of margin. Yes. Rate

the based that vasculature, don't we the expect be vessels our We to and not. will would you findings. expect With issue. ARIA rest action brain antibody blood of pulling on and from So therapies mechanism an amyloid those see of do

picture drug full studies. the we complete will safety do obviously, of out However, our as come

Mayank Mamtani

Receptor data Understood. you'd If to EEG, attention And you then, understand data recent to that that and your could line brain specific even top Sigma-X biology. great. has helpful in to have for proteomics that been in regards point will that, to? Any is both volume readouts the paying biomarker worth be

Anthony Caggiano

Yes, sure.

we that those out synaptic see are reporting be we'll So biomarkers proteins, GFAP, biomarkers that from canonical did the basically you and preliminary the expect complete read, the disease same we would to cerebrospinal monomer, changes NfL, did in look et these of to individuals as And analysis measures more the of doing engagement cetera. previously, refined modification. we'll from plasma proteomic at and target and then be fluid

learned the So as we'll as thing in based much time. pretty read well be same doing expand we the did it what on we've the preliminary interviewing in

Mayank Mamtani

well just of on with next if lastly, you then Phase the doing you're much able baked could -- flow? then And comment then know guidance II into investigator is activation, -- study MAGNIFY site to financials, on on And are to has how Great. feedback X the cash grant I have initial study, we expected X the quarters [indiscernible] so enrollment? runway funding your of the how but

Lisa Ricciardi

With from trial research MAGNIFY, tremendous the as enthusiasm patients. in well community there for is as regard clinical the to

like we group a And provide are PIs momentum there on in don't of enrollment. They guidance positive study. our enthusiastic patients. that So is other and studies, very

that can we So you tell much.

grants, And the on John?

John Doyle

to Mayank. With the grant funding, respect

'XX. we ramp of through this START balance dedicated And will So to trial. 'XX grant complete and we to as fund SHIMMER the up be we that then year progress trial expect the that as remaining

Lisa Ricciardi

was we your press how about in release Mayank, identified. that $XX baked question of much Is the that is million And Yes. the into right? runway? So the

are As you completed. are grants down Mayank, the drawn studies know, the as

So quickly progress is the studies, it's absorbed. how in a really grant we those of function that make funding

Mayank Mamtani

you next months guys. Got few it. an exciting to looking That's helpful. for forward I'm

Lisa Ricciardi

Yes, thank you.

are We Thank you. well. as

Operator

right now, hands. of raised have don't any As we

back your final like management now the hand to to I'd over for So remarks.

Lisa Ricciardi

in looking achieve for Thank is joining Terrific. on long-term our supporting and progress clinical milestones, multiple believe continued We We're II you to forward for creating build data us patients. positioned evidence focused CTXXXX's on we're to deliver in conclude, and important Phase readouts for potential we XXXX. To we're and value today. to our continue sound, science our shareholders.

Operator

[This concludes] call. today's conference

now may You all disconnect. a day. good Have

Lisa Ricciardi

you. Thank

Operator

Goodbye.

Cognition Therapeutics (CGTX) 26 Mar 242023 Q4 Earnings call transcript