Earnings call transcript Q2 2023

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Operator

Good morning, ladies and gentlemen and welcome to Cognition Therapeutics Second Quarter 2023 Earnings Conference Call. My name is Jenny and I will be your conference operator today. This call is being recorded. I would like to turn the presentation over now to your host for today’s call, Daniel Kontoh-Boateng, Investor Relations for Cognition Therapeutics. Please proceed, Mr. Kontoh-Boateng.

Daniel Kontoh-Boateng

Therapeutics you me in President today Executive of thank call Therapeutics and and Chief Officer With Doyle, today. are Cognition morning for of Cognition participating conference Chief Financial Good Officer John Cognition. and Lisa Ricciardi,

detailing to release quarter second is press as available as read the this Therapeutics’ available at cogrx.com. cognitions XXXX our well on which section morning’s now of Cognition the website is Form quarterly We on SEC press our A on results Investors with encourage XX-Q, report everyone filed release and website.

this is days. conference In through addition, XX will call the and company’s website for webcast archived be being

certain call, results could the implied statements We making Reform note is Act. by Actual discussed provisions management today business. forward-looking listeners forward-looking risks statements. Securities company’s call covered with Safe and during that stated will Litigation Please caution under those or the these be uncertainties to associated this on of information differ the Harbor the from materially due Private

of date time-sensitive call. reflect no are any live These forward-looking date previous this release quarterly that the press contained conference cognitions is events Including in filings. call the SEC of and on as of by statements or revise or accurate only the forward-looking conference broadcast. undertakes to to contains Competition this obligation update This Form XX-Q report circumstances qualified after filings. cautionary and statements statements information its

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

Lisa Ricciardi

Head we’ll Dr. progress on after On of Doyle, remarks Financial R&D the second performance conference and I Welcome today’s joined Cognition XXXX. earnings questions and Chief the Tony by for prepared covering good be call financial answers. Medical the XXXX, everyone. morning, you, of Chief and Officer and results Officer, call are our and share for to Daniel, Thank will company’s in John quarter Caggiano, Therapeutics which

shown be believe XXXX, effects delivered in of we clinical for and continues we neuroprotective continued evidence year, CTXXXX, the compelling our team second the execution leadership lead will quarter the a progress orally our what quarter candidate. In of of the the first build to

Our in from comes trial be call. this evidence most results, the covering we’ll which recent SEQUEL

investors, for on reminder data multiple a fronts. have we important As

target, shown that sigma-X CTXXXX receptor. we’ve First, engages its a

engagement this by Second, volume the of say slowing that consequences brain to our has endpoints SPARK results physiologic atrophy. in demonstrated is anatomical of trial

SHINE and placebo Third, in preliminary we data demonstrating study, we have as of to from study. just neurophysiology first that have connectivity by the compared patients measured quantitative the activity brain cognitive improved cohort added SEQUEL evidence EEG in and CTXXXX our

Lilly are recently operations LEQEMBI. most in our Alzheimer’s positive disease. events Eisai As of diligently to including progress positive research the in clinical the field, of reported the full and CTXXXX, to approval – we supporting data the pleased worked Alzheimer’s development recent team the have role see and amyloid

stop this and has is Mounting We moves of By evidence build cognitive evidence as the binding the to – impairment. the modulating by toxic synapses plaques, to in Alzheimer’s we the which doing amyloid species mechanism demonstrates may target disease. of oligomers to the the from neurodegeneration beta thus to optimal of slow sigma-X product ultimate the action Alzheimer’s progression monomers A prevent oligomers, of believe continue in Oligomers so, neuroprotective CTXXXX of the loss neurons early-stage prevents targeting receptor. disease. driving CTXXXX potential or are an brain that beta supports the the

and we not our date incidence believe an the market, on we acting LEQEMBI in of to anticipate do this seen oral on have be join By agent we biologics ARIA, other that these to may mechanism, studies. complementary As CTXXXX, approaches. novel any not

access will to likely believe of also administration administration oral drug and therapy. that the of an We ease burden

Now you our brief a on let trials. give me clinical update

As trial quantitative showed previously on to a the top positive Phase conducted had EEG SEQUEL The study. Netherlands moderate of synapse that results in our trial X a line we – measured mild reported who Alzheimer’s mentioned, was the have the top direct from with exploratory line XX by brainwaves. impact as evidence data function change or CTXXXX makeup disease. The people composition in

regions, Specifically, with waves the of healthy improved we brain. brain fewer and observed are a connectivity which wave which between just adults trial, are with In may to more normal SEQUEL between ready stable the a of or brain more waves, exchange proportionally for patterns background in alpha X the consistent unimpaired associated we restoring that saw allow activity these in changes considered waves, information CTXXXX slow proportionally also the impairment that waves regions. weeks. are of cognitive healthy

For we a in time of and neurodegenerative a like chronic Alzheimer’s of encouraged changes are see XX only these disease patients. disease, period short to in population a

START clinical has for first Alzheimer’s trial the In disease the July, X Phase site. that early activated announced we XXX

trial with the partner, Alzheimer’s ACTC. Trial Consortium, the Our or conducted is Clinical being our

These or with to months. randomized XX for expect patients enroll placebo America North in We to XX XX receive be disease. will once to sites patients daily CTXXXX

placebo-controlled measurable with CTXXXX we adults is who MAGNIFY atrophy, or to that expected Also in secondary geographic This AMD dry degeneration. people MAGNIFY in that participant. announced XXX trial to macular our dosed randomized dry trial designed diagnosed with a is to July, adults, the trial efficacy GA, enroll with is have atrophy. been study first the age-related of geographic XXX

an to is geographic in AMD, measure study, this with slowing the XX treatment, once-daily has assessment an CTXXXX progression administered In size. the be the measured months the as drug disease as dry atrophy of potential of oral will given non-invasive In for changes lesion a CTXXXX as to injection. offer approved context to intravitreal by a which alternative the

the receptors publication Sigma-X from remiss potential titled Journal dry I as its to degeneration. Lewy published if basic and along comprehensive function of target team Sigma-X this a biology a be for receptor, biology with peer-reviewed the target our would in macular therapeutic disease, highlight Alzheimer’s including didn’t neurodegenerative collaborators provides age-related diseases, review major of I authored Science, with therapeutic and age-related Now bodies of a the that article dementia International Molecular and

The publication exhaustive. work cited is in this

this on other our You publications find can and website.

research evidence through work of important disease team scientific the Our to studies building conference modification continues at proteomic produce Sweden. ADPD in

measurable in dry effects Our Alzheimer’s team at our was CTXXXX disease targets. at weeks Said and demonstrated shown analysis in impact the presented An AAIC age-related degeneration altering impact meeting pathway a Alzheimer’s model And we of another the ARVO proteomic pathways Amsterdam. just across of of X of meeting. macular ago, we have disease implicated AMD, on consistent, presented analysis the the CTXXXX in April confirmatory mouse biology. in way,

NIA NIA, including institutions, of Now much continues of over million competitive we from grant foundation. non-dilutive present. to of our a a long-time be the supporter which through received work $XXX funded application by a have cumulative science peer-reviewed process been which has scientific our work awards the in from we To early our thought-leading date, highly the view as through preclinical validation

a have non-dilutive funded in unique by among trials majority our of clinical the are We capital. peers that position

Therapeutics our Cognition progressing target In all summary, indications. on is

aggressive are to have our We set milestones on we trials. execute for driven

gratitude the our for partners our of such as half second our caregivers, the XXXX investigators as collaborators, to patients and express who have of and programs well want community formidable enthusiasm through and generous continues work to together our to have these XXXX, based to I As leading as team. science support the address forward our work sound to developing to institutions NIA as who We treatment and their our goal to other been on diseases. of in look well continuing towards shown new

Doyle. John? With that, John I to call turn the

John Doyle

Lisa. footing. the Thank We second quarter you, moved on a sound through financial

continued associations J. have CTXXXX Foundation funding from the through us execution other Phase SHINE key SHIMMER combined the with Our support trials. positioned operations, to across the and the X NIA, Michael and Fox grant advance

$XXX Since us associations the $XX.X in funding, remains founded, helped XXXX. of which end of approximately the QX these million have at non-dilutive million company was raise

financials Our second to of through commitment XXXX. our the With funding to cash third of stewardship, proceed extend to the support grant let’s the for from financial runway context, us with quarter enabled that quarter now XXXX. together our

Research and spending and was primarily costs clinical same with reduced manufacturing for XXXX. lower preclinical $X.X The in for to quarter $X.X XXXX period compared the June to organizations million related development due programs. to second and decrease XX, expenses research were million ended the

period were General professional in and million increase The and and other XXXX, administrative million compared quarter basic X June loss per insurance and XXXX, of $X.X $X.X a ended liability offset compared share The ended or officer $X.X lower to XXXX. share second higher expenses. net per million of the expenses XX, director net months or million $X.X by for the loss for same quarter due diluted XX, June the the $X.XX during to $X.XX fees, partially XX, second June for was ended a company to XXXX. reported mainly

XXXX, million $XX.X we in As equivalents. and of had June cash XX, cash

As we third that previously and to through is of estimate cash this sufficient the fund quarter balance expenditures capital operations mentioned, XXXX.

open turn questions. now Operator? I’ll call the can call the operator, who to the for back

Operator

the of Mr. Charles [Operator Instructions] Now line your of Charles, Cantor. question first open. line your comes from Duncan is

Charles Duncan

SHINE believe are just Phase the any you Congrats morning. And projecting progress Lisa, guess on that, Lisa, you you when kicking SHINE, have our questions of you approval. START taking I the and at impact have had that good that now? John, X contemplated availability mentioned for enrollment you and thanks if recent I I’m SEQUEL Or enrollment Yes, on drug being couple the for approved the if may on in a impact enrollment, LEQEMBI questions. Anthony, off however. data. all? wondering seeing its patterns

Lisa Ricciardi

said. Thank to investors Got is are question. I that good enrollment With me we I LEQEMBI, it. are cured And the continuing complete tell what With trial in is end to can year. reverse seeing let regard trial, to that and enrollment trial. when are we well, Great – enrolled this to you the and we we’re going we what our regard have of you, SHINE point, morning. our our Charles goal by know, let completely have at

fully The and needs The and process belief commercial be uptake there. our on remember aware at be is, of is to need Doctors it’s will answer that patients to trial of to be a lengthy it to it, pricing, is the our an our that haven’t seen and be need thing LEQEMBI time. So there is to launch enrolled out date right? no, aware we impact enrollment.

START. second going part on I’m how the let to was question. Tony your it comment Now impacts of That

Tony Caggiano

Yes. Right

or time. that period sites, trial, for on we’ve sufficient said a been the they’ve on So START first the Lisa allow have for on be antibody just of been does which to individuals brought provided therapies that

like in we But obviously, uptake. else, of the provisions we speed know have the trial. everybody So do not that

the be evenly throughout different they’ll balanced So groups.

Charles Duncan

Okay.

that would accommodated that by you’ve So not SHINE but have then And exposure fully enrollment. SHINE. on of your terms the will a that projections I question this trial? you had end LEQEMBI year, follow-up in when in have, If top may, enrolled data anticipate line from START of I question the that’s

Lisa Ricciardi

Since a it’s December, There months June. the a X-month in and trial patient the up the time comes trial, of last it’s veracity, cleaning over they if summer if in rigor data, the Charles will. complete ensuring is period you

we say – prepared next goal move say have months of to we a last X is If patient year, we is this able The would would will. to the I That that accuracy, quickly we with data. would moving more top time process. target. begin somewhat from at we’re line So

Charles Duncan

does regard – study. with to an just START, then me, remind And that’s Okay. XX-month

just wondering me the So I’m I could audience? incorporates you an remind guess it interim look, or if

Lisa Ricciardi

Yes, Tony?

Tony Caggiano

Yes, look. interim not an it have does

throughout it’s So going readout be study. the to one

of are course Now the there study, analysis. throughout the no assessments but several interim

Charles Duncan

Alzheimer’s year from mild-to-moderate next in Correct? like DLB. seem reads SHIMMER data and SHINE in So then

Lisa Ricciardi

is year. right. That’s in goal trials The those to both of enrollment complete this

So similar would year. this top line next the for line time time be

Charles Duncan

the taking for Okay. on progress. Thanks Good Congrats recent deal. my question.

Lisa Ricciardi

you, Thank Charles.

Operator

question ahead. comes Jay of is line open. Oppenheimer. line the your Please from of next The Olson Mr. go Jay,

Jay Olson

Hey, all received top you following from for from congrats results you taking about the the on talk Can KOLs SEQUEL? the progress. feedback our line questions. you And thank

Lisa Ricciardi

our from questions Jay. We received a of investors, lot

institutional around and and understanding results the investors As better. we you retail know, were the questions have investors

time being So used ago is and think it other in This a way the tool, in conventional EEG, interrupted disease, years of people say, in several forms first an study in was MF, exploratory epilepsies, disease, Alzheimer’s it’s about. but meaningful COVID. I then started of it’s while thing a increasingly would epilepsy, neurodegenerative terms not by

to better looks understand they when go we normal the do to non-demented they adult. synapses patterns the people is wave with so be through return behaving have see then beta merit healthy what would value of the in that about bankers, our and investors, the And professional we opportunity versus why like alpha are data, The of the proportion the other the a as to to excited results study. able so show colleagues,

We again, feel patients. in like to that is extremely XX only this positive. show And

is So with engagement, understand us them. nature how as said, help next feel one feedback trials? – evidence, brain the on results that that share is mean, I are to more The does this of data. biomarker read we what questions their of it target structure, future that piece in these changes We

we Now and a of there’s about that this study. neurophysiology data, there when opportunity those another to is excited feel good positive things, signal the why given understanding explain we’re

Jay Olson

any mentioned small the of that. specifically a for synergy Great. comments Thank and And a molecule where problem a can in with is anti-amyloid you that your particularly lack about you’ve like the risk-benefit antibody. an about superior homozygotes, between work just on combinations. potential overall at have And ARIA think just CTXXXX done CTXXXX you serious a XXXX, population you talk ARIA And looking profile? is ApoEX preclinical could then since you follow-up

Lisa Ricciardi

to to response about in effect. differential tell. with too ARIA Tony, comment patients date Jay, we’re regard patients our to to ApoEX the further, in population, but you soon be in have tell studies, likely you there conclusion road want of any is side the not what any will other we’re down the we and suggesting opportunity Did that at It’s combination? what to I an doing those or just at look can studies

Tony Caggiano

Yes.

our data, study, provided therapy, Clinical will allowing sufficient Consortium, period study XXX in combination which a conjunction been the for of participants with from is on Trial So come START the time. is Alzheimer’s again, which antibody they’ve

with the data of conclusion good I conclusion that at two some So have study is data there that effect together. – whether an will of the have mean, will on some additive

Jay Olson

on you. be protection any CTXXXX. for as thoughts could about Okay. an generation or We accelerated you support neuro to biomarker And that. synapse Great, thank predictor useful a predictive or pathway as forward approval potentially surrogate, had look curious we’re also, that a for and

Tony Caggiano

looking we at broadly biomarkers. So are

we’ve through that done and drug our spinal [indiscernible] as obvious once which the and modification. predictive whether As things others be in be before and candidates, effect. all fluid right, on you’ve seen, as we’ve now used able the There’s pulled candidates for data, might treatment from exposure we’re of individuals NFL, analyses are of GFAP, I past after disease for a looking those And well. of to see have they we’ll looking accumulated enough mentioned, markers novel and

Jay Olson

Okay. you. the landscape treatment one you sneak Can in the geographic fit in just maybe atrophy. talk evolving how and then thank about maybe I CTXXXX just you on And commercial would could if there size the Great, of see where opportunity? question

Lisa Ricciardi

is may large, the we’ve size very we on we’re really looked of It’s after that based population. Well, an differentiation an be important we the is be Alzheimer’s which, – the you target done, going population, aware, is AMD taking as significant really Jay, population. to research of the the dry think right, the opposed our very, early to twice over it’s an believe at as size of oral The target, drug market having the we’ve will commercial injection. drug, patients say,

by approval and many [indiscernible] in seen that the Iveric, pipeline concerns drugs their there, complement-driven of pointed they’re intravitreal out injection. addressing administered with are and the has So landscape, the that as There have you more the out, you are drug. have doctors

are educated this drugs and will population, belief significant our treatment even could market. for these we going with injection. the we be when and for very get a there seeing intravitreal drug the first-line enter fact our launch for are to that the benefit perhaps reasonable enough on so options believe that Physicians is we’re And watch patients therapy not patients

Now, front all of in that us. remains

not with But of market, improve a for drug believe us, a sitting important one convenience our market and We have efficacy the because potential these safety perhaps first. today, we you’re offers to dealing that here safety really injections. and prove large that’s

Jay Olson

That’s Thank Great. questions. all super for the taking helpful.

Lisa Ricciardi

Thank you, Jay.

Operator

Aydin from line your of question Mr. the Ladenburg. Next from Huseynov comes line open. Aydin, is

Aydin Huseynov

everyone. to quarter. follow-up of far from questions. question the so the Congratulations couple questions. appreciate a just this I And Great takin progress Good I ask morning, wanted the colleagues. to

So both initial of imaging were lecanemab, considered donanemab, on they coke amyloid success levels PET of based plaques. beta

displace new biomarkers we PET of the with amyloid think beta do center you So exploratory the if the biomarker and is in that to of of EEG. – target front CTXXXX such be beta amyloid plus endpoints imaging terms instead if the should and as ligamers,

Lisa Ricciardi

make Aydin, to over it turn then me and Let Tony. few a comments,

our was an neurodegenerative Amsterdam, in have designed across partners study in expertise So as and multiple diseases. exploratory EEG our EEG deep colleagues study a by who

approval, it was it we be impacting drug about we more of disease to front So never the intended pathways, regulatory nature, to things sort did. this and and an center underlying learn opportunity of

That our success study a perspective. is from

in and points, changing we’re don’t I my would end a to changing Tony say, like a I in in for is collectively the change endpoints along a experience going bit turning end ocean. around we in with As points. think big industry, the ship see think John,

we and approval don’t have I other are going For that FDA gone the to I right know. that two have the approval some process of endpoints. We period at through time, process drugs don’t in know. and look is now, think don’t the

engage in more. before those to discussions have know We we

Tony Caggiano

Yes.

the with the – that and mixed of of more you right, Eisai between lesson the success another then as at a study trials, us, the and plaque for and successful as right, Biogen Lilly. mentioned, result is with and correlation that I the think we removal looked

binding plaque shifting through So the right sites. we’re we them measure oligomers low that the cerebrospinal we have we the from amyloid that and their the working species, blocking Once thereby mechanism, in the prevalence is the interstitial we than can but toxic can to rather them, this them evidence a different drug ability through and of of fluid. our then removing concentration highly clear right, right? Now displace space

believe we toxicity. So we that prevent will

a Now species. really of will larger lead evidence that lot have we we nor do clearance that, to plaque the a believe don’t of large

for be best So antibodies seen it’s the we’ve think don’t an drug. may our it that appropriate while measure think measure recently, we we necessarily for the

Lisa Ricciardi

like a of cognitive And be measure we with are CDR therefore, ADAS-Cog endpoints we FDA. anticipate would what discussing these Sum conventional and Boxes, function, XX the

Aydin Huseynov

Yes. this you have FDA? went you the Understood. Understood when But discuss think to because to look you that that and have of at do with able will when with you Because think FDA. approval through initially data initial discussable these these data do approvals, the biomarker data if you’ll accelerated discuss. we’re drugs

Lisa Ricciardi

studies, and we Well, then trials, year, SHIMMER FDA as a call, for enrollment dementia to we is bit AD goal conversations. earlier Lewy bodies. up with data our that this indicated and is our anticipate cleaning the and SHINE the If time on Aydin complete complete dementia we those enrollment data to year the positions have next at with down sit for X-month us having this mild-to-moderate

the in timing from the is a of to work dementia with now results question discussing your agency. the our response So year

Aydin Huseynov

question more Okay. And dry Understood. Appreciate AMD one study. that. on

study? you you plan to do you you partnerships? any AMD when do this will data? plan think how And the second Do have is question regard finance initial efficacy dry So

Lisa Ricciardi

years of regard when X.X we year, enroll than it’s need have run-in to patients study. the period With we’ll a an XX-month to data,

talk drug continue we’re in before CTXXXX the continue period to to with data we opportunity there’ll companies With study. time have plans. this to educate investors indications. various creating have in So indications, about be on We both and regard date, the multiple interest strategics to our about their partnerships, just no of we to some we

Aydin Huseynov

it. Got

you Okay, questions. taking thank for my

Lisa Ricciardi

You are welcome, Aydin. Thank you.

Operator

this remarks. go at time. Please the I’ll questions the further call to back Ricciardi. CEO for closing ahead. turn No Cognition Ms.

Lisa Ricciardi

commitment conclude, accessible and to order innovation to leading both patients Thank and and scientific you, that clinical are in their reiterate convenient Jenny. me our create To therapies disease-modifying for let caregivers.

supported on you delivering us work, progress our morning. have everyone, good for shareholders remain for this joining make long-term we Thank our we As today, process. a focused us value who in in and have

Operator

Today’s conference call.

may You now disconnect.

Cognition Therapeutics (CGTX) 8 Aug 232023 Q2 Earnings call transcript