NMRA - Earnings call transcript Q3 2024 | Neumora Therapeutics, Inc. Common Stock

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

Operator

Ladies and gentlemen, thank you for standing by. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to Helen Rubinstein, Vice President of Investor Relations. Please go ahead.

Helen Rubinstein

Good morning, and thank you for joining Neumora Therapeutics Third Quarter 2024 Financial Results Conference Call.

Before we begin, I encourage everyone to go to the Investors and Media section of our website at neumoratx.com, where you can find the press release related to today's call. With me today are President and Chief Executive Officer, Henry Gosebruch; and Chief Financial Officer, Josh Pinto. forward-looking Development, of will point and the we be and the us out beliefs. Research based will portion are Q&A call. I'd making of Rob current join Lenz, for that on Head our which expectations statements, like to may These results to our subject are risks and materially. statements and uncertainties certain actual differ over review risk factors I'll and filings SEC our details. With the discussed that, release Please for turn now to call the in in today's Henry. additional press

Henry Gosebruch

all everyone, morning, our conference diseases the patients, of quality Good a Thanks, X.X you for are globally. collectively only our medicines thank society disease. generation but not to of for life, portfolio and of large. a And at that their targeting need. To robust billion alleviate their Helen. and joining programs, us of They novel in with goal, of we Neumora, significant of achieve the and all first impact for families bring respective our at of brain one affecting have mechanisms challenges ever for preclinical caregivers, somebody is developed call. Brain forward upwards leading on greatest substantial the goal people action We disability clinical indications. affected generation, cause unmet X by quarterly medical represent of next to the know

discontinue and the difference conditions. Major making to significant programs mechanism has challenges, are XX affecting responses our cause Yet of and/or Disorder potential aim tolerability MDD for of treatment reshape to living action XXX leading approved more with program, a significant of treat the to families often been our neuropsychiatric novel drug target of it. People MDD the Depressive each disability inadequate which has with years lead we of indication, that of we care start than is or standard treatment. Importantly, been than to experience with people. more believe the treatment them patients a MDD treatment investigating a other serve. I'll a has leading its Navacaprant, we worldwide, million for since and it

titration. with Navacaprant designed novel potential difference to XX% Navacaprant placebo-controlled randomized, with development to anhedonia don't as approach receive kappa moderate Phase beyond are standard X achieve a studies, tolerability use reshape approximately of agents. We the that to make treatment efficacy MDD. MDD to be has with patients are up pharmacological is MDD of And of remission treated KOASTAL-X to with has once-daily efforts fact, well daily patients treatment or dose in the Navacaprant don't antagonist of adequately double-blind safety and weight gain, severe in treatment has people with KOASTAL-X, KOASTAL first-line demonstrated our experience monotherapy antagonist replicate as care. It no to III favorable as associated existing adult includes a the once-daily moderate with XX% efficacy to other in severe without and depression symptoms, lack a Phase depressive of selective MDD Navacaprant profile XX-milligram easy dysfunction significant X evaluate program oral if successful. The events KOASTAL-X, therapy. anhedonia the in treating opioid by clinically commonly as opioid and our receptor to patients a developing adverse designed an activities, to including validated safety is of been the and experience MDD. sexual In study, is or from or The pleasure which believe the II treatment. monotherapy we receptor potential studies. In Navacaprant ability in not highly kappa either potential of independent

support know in To to design KOASTAL-X detailed the our successful KOASTAL-X deck. We are to both also forward evaluate next extension state-of-the-art that enhancements success and execution of open-label the data KOASTAL year. are laser-focused readout significant top half deploying We approach includes in operational and Phase and We designed studies study are we an program. designed and which of for strengthen KOASTAL-LT, KOASTAL-X the crucial to year study, KOASTAL both to that long-term we probability are advancing studies, of of end corporate line design to are data Navacaprant. study execution on the around the II, first a look from MDD from to this safety relative and

pleased Phase treatment are designed bipolar We are broader development for powered study signal-seeking powered in also inform to populations bipolar a the exploring to look in second effect not size, show to statistical is this This the significance. Navacaprant it sharing disorder an development advancing including in We of to depression, study. further potentially disorder show is to as results forward a XXXX. of bipolar II as and II be Navacaprant of potential study albeit from half

currently antagonist NMRA-XXX, are vasopressin Xa XXXX. in we Navacaprant, from look to second disease with a evaluating forward data in reporting study of agitation. half that receptor study signal-seeking Ib the We Beyond Phase Alzheimer's our people in

we medicine. in are an MX important we XXXX. We with well to our the that a our several first MX MX franchise for progress leader continuing become of with IND development, second positive of in positioned allosteric to in or are PAM, believe a half PAMs new class modulator, Additionally, an franchise expected of Muscarinics,

are novel deep clinical conditions pipeline and Parkinson's of Finally, ALS. schizophrenia, such additional Alzheimer's agitation, opportunities preclinical as a addressing and we advancing

call of our financials. diseases. With achieve redefining overview, With Josh of are development I'll these that turn our review to medicines over we Josh? novel our brain way the to for believe programs, I the to well mission on

Joshua Pinto

Thanks, good everyone. and morning, Henry,

the take encourage release you some of for and key issued quarter context are few highlight detailed third I financial Our provide this press read. the moment results we in morning, to I'll a points. to a which XXXX that

million balance disciplined us us increase III capital our Navacaprant, growth we strong that to into allocation for sheet on program to support programs. ended ongoing equivalents Total realize the by for a the to believe which this financial our third third operations We $XX.X focused our $XX.X will expenses cash, operating primarily to were rest business. We places our and believe quarter period across enable of investments the position our across with studies are support million and multiple of catalysts the goals. cash strong very mid-XXXX. to on marketable execute runway Phase we portfolio securities, the activities in expect XXXX. in to leverage same quarter was in The advance industry-leading we for million driven the related As our CNS we pipeline, compared to $XXX.X

Navacaprant XX including the bipolar data X In X next have III Navacaprant MDD, on in fact, readouts catalysts over we NMRA-XXX with clinical Alzheimer's data and months, agitation. for the in Phase disease depression in horizon, for

that promising Additionally, achieve neuroscience of an early over that believe Helen evidence. supported well hand the and our to long-term I'll Helen? preclinical with pipeline industry-leading by operator. now Q&A growth. With to novel targeting I this sets portfolio action are mechanisms to that, call comprises programs represents the up us manage

Helen Rubinstein

Thanks, Josh.

to question. yourself I that the I'll one it ask operator, Before you to limit turn over

free you to If feel queue. return an please to additional have question, the

the to operator turn it I'll over to Q&A. Now Operator? handle

Operator

Stifel. Paul Matteis question from with Instructions] [Operator Our comes first

Julian Pino

there wondering upside have share? be for And original on any if able for final KOASTAL-X This there? guys powering a just to there you Paul. is that curious we're is sample assumptions We're that you'd Julian to is size

Robert Lenz

Rob. is take This question. can I that

each. When in a to patients So all are in XX%. seamless approximately to amendment. X targeting Phase us protocol increase the ongoing, studies, conduct up powered have XXX a XX% They were ability replicate without studies the are approximately we build III the KOASTAL we design we by to did or meaning which enrollment of powered actually way, in requiring at did

forward the enrolled sample on including to size line sharing at look So top the the population, final results. the details

Operator

Capital Markets. question comes Our with from Abrahams Brian next RBC

Brian Abrahams

shown rates pretty on the in can progress. that be have Congrats Recent keep sometimes neuropsych down placebo studies to studies. tough all

the employing, and wondering believe the how your in confidence bit the KOASTAL validated sites how So of of and working centers? the a you across of QC some most diverting little reliable measures they're the balancing about was I could you patients conduct you're that you're if in talk maybe terms studies towards

Robert Lenz

Rob question. again. can that This is take I

a of success. probability implemented program in level level measures well KOASTAL study the the at at increasing of a as program we've overall the on as number to So really focus

number So X design that of think a program we need both and we're just trials mention level, from X at of those as the I'll a execution success. probability And increases an then would mentioned, positive. with as conducting study we that the a few. perspective as there's we overall level, of that be at the oversight to things that expectation perspective implemented well

by is concepts anhedonia, better Phase from the move outcome design So the MADRS fact in the we the MADRS showed that study. Navacaprant This with of is to from II did we driven primary clinical the measure. our as a that benefit perspective, with, HAMD-XX something the really which captures

outcome placebo. expect raters turn So between appropriate we by a execution the in the for HAMD-XX is historically And reduces mention utilizing administration the have know benefit and sort patients to we're as of what our Phase the degree placebo better reduces MADRS. see bias, We in symptoms captures those we depressive few. One trials. ensure would allocation that that to trial equal feel primary active state-of-the-art. really feel the coming did patients measure we of to on coming that into help just in the that than going holistic implemented side, does. We MADRS then central those implement which I'll rates of the we is expectation the assessed into III

compliance terms video technique the placebo, compliance but literature, this administration the are in amount the of conduct on supports that a placebo drive a sites, a to also study. And also MADRS. mitigate apps the administration patient the help sites And each fair And script. having of spent responses. something then of administer every that that implementing study time with again, can that's the training in and confirm is drug we to patients specifically We placebo

been to doing things those overall we aggregate, really study. in of the success of we've each the So increase feel program probability on in laser-focused

Operator

Suneja question Our comes from with Yatin next Guggenheim.

Hanxing Gao

for This conference quarterly is Iris call. your on Congratulations on first Yatin.

guided II. previously than lower discontinuation in rates Phase for you So

in getting XX% we're to it the readout, to rates fair to that assume range? Now X% is discontinuation the close

Robert Lenz

discontinuation seeing won't overall I line look on comment and top of baseline sharing in results. the Rob. when discontinuation we we the say the show rates is that This the were the encouraged the the I'll by specifically forward details on to rate. Yes. study details that characteristics we're

Operator

question William Blair. comes from next Our Minter Myles with

Myles Minter

drug. profile whether or patients that the itself We've and might been that's whether underexposed pretty drug for a a being just the CNS to of for here Navacaprant safety be some maybe on inbounds benign receiving sign inherent

people of mechanism, be this for are pointing specifically we somnolence that lack levels think at dose, the to seen drug. XX a than expect I for mg the it might CNS lower

kind us, that target in occupancy of XX just ensuring from, program? the for guess, dose kappa? So you correct the KOASTAL ongoing for can achieving where like, selection how set you are I exposures mg And you're level came receptor at your

Robert Lenz

This I is Yes, that. can take Rob.

So based encouraged been on I'd the the overall, of the totality studies safety Phase II that's we've quite and profile the Phase both say by I from to-date. and data

or I seen are troublesome weight of existing that gain seen dysfunction. side we think sexual therapies importantly, the haven't effects some like with

in through study brain is the throughout really approximately occupancy conducted dose the that XX% exposures what with a observations. assess occupancy period. the confidence the One significant In which exposures found our occupancy intent resulted achieves And on we we XX-milligram the are and couple dosing that dose to specifically a period. around is in in predicated of in entire dosing the selection, PET resulting human receptor that's of receptor doses terms

we well look as say So to G-protein peripheral of to biology. Navacaprant. high then that XX% degree across with of receptor. There implicated the have a have north sort mu as pharmacology, a pruritus, in of receptor objective And receptor receptor achieved or around the that And with There's certainly when we terms get of confidence pruritus, mechanisms. above is systems the coupled number well been as kappa pruritus in is XX%. specifics opioid complex a central mechanisms as are opioid certainly I'd histamine,

II, Phase And the we the pruritus to say of premature in any Pruritus see low Phase observations see so pruritus. at We a level. study not sort extrapolate it's did in I I'd but did of

highly the So selective Navacaprant we about -- designed a mu. we've kappa XXX-fold of be got over to achieved specifically That program the we've that. was We've objective molecule. and selectivity of

profile tolerability part the favorable And so seen will we to-date. think be that that driving we've in

Operator

Suvannavejh Graig Mizuho. from with question next Our comes

Anthony Petrone

is This on the continued Charles progress. for Greg. team for the to Congrats

commercial studies, thoughts regarding strategy potential So and assuming strategy? X positive initial your Navacaprant's labeling share KOASTAL you can

Joshua Pinto

here. Josh is This

the in to that look be this up, successful as at the X we program with KOASTAL the team sheet the point own and that on X IND of need well we set to we our to believe to balance As are well the our program within commercialize both our studies U.S. file as believe

Operator

comes question Wainwright. Douglas with next H.C. Our from Tsao

Douglas Tsao

think competitor without from look. KOASTAL in And And programs may, got a question, for I mentioned obviously I a second be readout an would their potentially we resizing the one, negative you program. catalyst Just curious interim opportunity MX the if I'm a that? taking just what the then just with for a

thoughts how if there's influence any program? curious on own that might So your just MX

Robert Lenz

is can with this -- the question. first Rob. I Yes, I start can

to we is forward ongoing through of line reiterate I'll that up conduct formal way typical top having was a part study not protocol sharing details the design without in results. was an look submitted sample FDA. increases size we the characteristics say I'd that of amendment. this have design the to to implement And this when from the the just So a

MX comment not our remain In is other franchise. companies' on to terms say policy in of will data. MX What program, the confident it's we our I do

each Just chemistry by and has we multiple in reminder, unique have unique of do way programs, of attributes pharmacology. which

experience of in Muscarinic sort from in that's were and group recall, and academic-leading space. way industry there Vanderbilt by the chemistry programs Just these or has licensed tremendous of really that expertise medicinal a

So much MX year. forward the clinic first we're PAM half the in of bringing very to next our into next looking

Operator

comes from of Our next America. Bank question Charlie with Yang

Chen Yang

if KOASTAL-X? Can enrolled? whether And was the you last it the when just was confirm for patient so enrolled

Robert Lenz

is address Rob This I again. that. can

and resources details top to end So to just we -- as the the of won't help And results. those things top of in reiterate results ensure place around that line that share delivering put enrollment. our year share forward that will we can I comment confidence the we've we the in specifically look on the details happens. line the we sharing and

Operator

Our William next question with Myles Minter Blair. comes from

Myles Minter

MX that the around just outside which to Vanderbilt Muscarinic on focus changed have got selectivity? any understandable, Just do the of IP IP agonist your you drugs whether to you for other MX? maybe It sounds franchise, on with PAMs, but is in are or pivot you've MX, that and flexibility selectivity cholinergic like wondering have

Joshua Pinto

Josh is here. This

PAMs Vanderbilt, So point. with pull programs feel, Myles, about we mentioned, our as year. clinic next terms potential. that half in has Rob franchise the has been And the first that been that we've on We of in moving able to together to this of our very MX it has the good believe partners focused into up pharmacology at

with be but IP put able so built further And have, to going the not to specific we I'm around Vanderbilt. and about that together any we've what the feel comment just franchise good with

Operator

back With call. today's of portion closing Q&A for that, to the I'll remarks. Gosebruch conclude will Mr. That turn it

Henry Gosebruch

for to morning. Thanks, joining this thanks us Josh, again and everyone

it's development we our steadfast to redefine improved people therapies from goal quality at diseases. heard, life you've generation as neuroscience bringing treatment next for of and suffering forward to remains move be by exciting that outcomes novel the time of forward, And drug As brain offer Neumora. an

end of reading data of first first of this the for around X III Navacaprant more are We out the with next to our III the X studies readouts forward year. Phase Phase looking half year in

to our we year Alzheimer's opportunities team. ALS, such thank and this like for and deep take As of dedicated creating and schizophrenia, Neumora. I'd preclinical agitation, a discussed, catalyst-rich novel to address pipeline Neumora beyond advancing talented to opportunity upcoming conditions also Navacaprant, are as additional a clinical Parkinson's

the made of a and commitment progress the have we Thanks is we of their All patients again, serve. the hard have work to-date culmination wonderful and their to day. everyone,

Operator

concludes This conference. your you. participation. for Thank you the Thank

disconnect. may now You

Neumora Therapeutics, Inc. Common Stock (NMRA) 12 Nov 242024 Q3 Earnings call transcript