Thank you, and good afternoon, everyone.
quarter Results first Conference Corporate our Call. to XXXX and Financial Update Welcome
reporting is the our financial Investors press be quarter our The release XXXX, XX, results Exchange Form for section will Commission. MindMeds ended March on today & of available and website report and with quarterly filed XX-Q the Securities Media the in
Chief and Joining me Executive Medical Dan Officer; Dr. Karlin, Halperin Dr. President. today is Financial Schond our Officer; Greenway, our Miri our Wernli, Chief
making be about plans, we'll projections During forward-looking efficacy statements, regulatory subject statements call, today's research in and are quarterly future progress XX-Q. most partnerships financial XX-K risks, processes that limitation, without report certain statements are product to filings approval the the recent and expectations, including, and prospects.
These and Form our Form candidates, safety, development various potential SEC, and such in of annual and associated as clinical changes including described regulatory and on with market made the conditions, on the report with difficulties our
in the are the significant MindMed's Forward-looking date estimates filings occurring management uncertainties and of the and nonoccurrence course we opinions normal with other business. outside the assumptions, the the as described on of including made risks are of of SEC made, statements or based the of the events statements
statements to such as are You May are update cautioned as not if X, any to required on change, these of except today, made obligation law. MindMed place statements, which management's undue forward-looking by reliance XXXX. views disclaims even
brain life-changing many to delivering to our commitment our advancing organization individuals health treatment by to new reiterating options like would disorders. the begin living with I and deep
execute throughout the we are to few steady months are bring lasting our or our product anxiety low as milestones our MM-XXX progress our make of and as our pursue in positioned ADHD. readouts our and hyperactivity or and this generalized candidates across from of year, trial shareholders. laying including to reached repeated in strategy first believe Phase Phase trial our disorder, market, multiple to well lead we Xb on well GAD, disorder of XXXX, dose to the for of value As key priorities continue pipeline, MM-XXX treatment create proof-of-concept data In to we foundation Xa we attention-deficit we from the
to the Additionally, year. in first we of later expect initiate trial MM-XXX the clinical
our Before further like data updates, we evaluating top-line our of to R&D treatment and by highlight Switzerland. II Dr. investor-initiated into lysergide Phase in recently presented the dive or Matthias This disorder, Professor financial Hospital universal the the I'd and depressive double-blind trial trial Felix positive the from in MDD. UHB Liechti University led Basel psychiatry was major hospital Muller, collaborators or and at
Lab psychedelic As and with trials ongoing patents Liechti's patient and other a reminder, This healthy have global and Professor volunteers compounds evaluating rights includes and investigator-initiated associated in from populations. data compounds. lysergide data, we to exclusive research numerous completed both
lysergide beneficial drug this effects of dose data encouraging treatment. secondary Data similarly Further, the clinician-rated depressive was study inventory or a was a [ drug and dosing by its demonstrating day, well endpoints control lysergide of active dose Our in collaboration investigator-initiated [Technical benefit Difficulty] trial MDD. pipeline. second investigational dosing and and on rapid, scores. to significant maintained from potentially underscores first with which also the received the weeks. tolerated. in to the ].
The dose symptoms day, change XXX-microgram X mitigate which in lysergide XXX-microgram in by An was Patients the of trial of were a X endpoint up potential by at impactful long-term XX particularly XX used demonstrated this was and microgram symptomatology the of development measured the clinical weeks, as group has small the and potential IBS-C our of Topline which from durable, lysergide primary reinforcing lysergide of weeks, has been separated
Given lead updates form excessive MM-XXX, and positive debilitating impairment ] I'll clinical our and associated of to program particularly the program, our of now for lysergide is to MM-XXX anxiety proprietary are functioning. degree program. social, occupational, and the and in which lysergide MDD of other results GAD turn relevant disorder and with lead on optimized an GAD D-tartrate persistent activity of and with health also treatment high GAD, development of the mental starting our ADHD. worry, pharmaceutically [ comorbidity can to significant R&D a in
noted innovation the little diagnosed in U.S. years. GAD, the of and and several incidence the treatment past very increase focused prevalence With the over with Europe GAD a on in individuals there's been of
options tells as Europe more who and a more could having for particularly true is of Additionally, patients of with tolerability.
This and are durable favorable benzodiazepine. we've to rate low a research and anxiety. practitioners the the in class safety pharmacological also intolerable not adequately antipsychotics The by SSRIs, U.S. faster, is safety despite the therapies a offer of responses segment number conducted new efficacy in that treated demand remission result significant of all and available who is of This there's continue and patients profound exhausted and a tolerability as increasing. challenges experience available SNRIs, of the healthcare patients well multiple
for by the in Xb enrollment GAD Phase the XX Given and of new a The total results Patient XXX our MM-XXX. progressing need we a single potential a the will who is XXX receive in of are therapeutic enroll options, well our data growing trial for dosing supports or participants expectation of to administration sites, treatment encouraged across which of active up micrograms extremely placebo. of trial MM-XXX we and our late XXXX. top-line reiterate will frames reporting
strategy GAD primary arms as objective trial measure the weeks dose and The of well mechanisms primary X development MM-XXX our functional and deepen as for weeks with effects X clinical the a this endpoint administration understanding results its post-dosing. of anxiety selection determine across study The scientific to for with of will super XX after guide action. underlying in to MM-XXX up symptoms reduction is at a in treatment
As are for we also mentioned, MM-XXX ADHD. evaluating
to through late We top-line expect XXXX. data trial Xa in our report Phase
outside Xa weeks is trial Basel innovative administration neuropharmacological Switzerland our study clinical trial this session-based of who immune real-world been conducted ADHD deliver to XX demonstrating MM-XXX is that of repeated of collaboration explore potential In doses this first well MM-XXX of or assessed being Phase clinical expect and the change X XX-microgram enroll component trial, placebo comprehensive we combinations. baseline Hospital total serotonin proof-of-concept as a and effects University patients of to agonism. to will development harnessed adult of by is repeat University administered effects agonism, both MM-XXX regimen we receive of a the twice date, weekly our in from ADHD. setting.
To treatment AISRF therapeutic the for study to in suggesting and This treatment. endpoint recurrent dose Netherlands with primary an a administration a this Masters ability strategy, broader of perceptual frequency have the utility symptoms Our The innovative the in are of no with the has designed Notably, X serotonin participants as [ the evaluate harnesses MM-XXX weeks. is after as low reported regimen ] which the SAEs in been dose MM-XXX with of in
We effects. sustained innovation administration. robust single-dose the require document delivery to have as the which plan, and GAD a key in is psychological the it of in socioeconomic delivered such challenges pharmacological as product clinical of and delivery and is a an stakeholders our taken on a outcomes product leads educate candidates. to is with intervention and health by will generation proposition economics will strategy, MM-XXX.
This data to occasional our session-based market revolutionary action clinical recognize value profound agonist, priorities research advancing driven and The develop are of ADHD mechanism superior required profile of and value of receptor why XXXX that commercializing for a of pre-commercialization build economic potential to external we burden a the innovative MM-XXX advance access only one all embarked and the be MM-XXX We ceratin approach of its potent believe
As we clarity to look the greater to program novel each of on for our forward path forward product providing pipeline, maximize our progress and the we commercial reach model candidates.
applications intellectual applications with applications. projected As pending in strategy, dates a reminder, our dosing, treatment These pending compositions, respect dosage others, PCT property covering patent to among with methods XXXX. formulations of XX our include and includes beginning portfolio XX and expiration U.S.
strategy. intellectual part protecting property to retain product our of candidates comprehensive Additionally, market our protection to expanding we continue and rights as portfolio our and are aggressively all
as characterized the lesser levels effect, effects and communication stimulant pathogen symptoms MDMA and to with the feelings like [ extent, the and core can tolerability prosocial to interest. of MDMA by activity is a to demonstrated synthetic to and hyperthermia, and would is of from acute emotional compassion. treat disorder, of core and of or RDMA enantiomer prosocial is or liability and a treatment synthetic I neurotransmitters is autism to studies behavior to diminished for pathogenic of neurotoxicity, a prevalence, of feelings Now symptoms there compared interpersonal it's in patterns therapies has it the referred that to activity, are increase connectedness suggest which social repetitive development no interaction, risk increased synthetic brain, warrant.
Preclinical growing exhibit and Despite resulting a because atypical abuse while turn RDMA, RDMA which MM-XXX spectrum of profile. [indiscernible]. restricted that significant MM-XXX ability MDMA the in increased and of less merger the ] favorable social is it or ASD, also reported is to a sought other in approved molecule potential ASD. norepinephrine a serotonin in
which engagement population. for demonstrate a its effect, social MM-XXX medications rather a of result sedating ability currently the having often used off-label aim is to enhance ASD or blunting and to Our in interaction is than
a on Florida of accepted in to MM-XXX the has presentation Clinical May Society for our from Importantly, Annual late-breaking Psychopharmacology is of June XX the held Miami abstract ASD at study been in American of X. Beach, being model XXXX Meeting preclinical
evaluate as all healthy to early continue explore individuals clinical anticipate This trial With to opportunities a this in and to further completion comparative with MM-XXX to parallel, and initiated excited objective our into support be pharmacological X I even to the and pharmacodynamics pharmacodynamic the believe generated tolerability of is later-stage of pharmacokinetics later our neurotypical we with In research RS We Phase understanding we and signs of efficacy and We in healthy extremely University the early volunteers characterize endocrine and year. through study will pharmacokinetic XXXX, our and accelerate tolerability are we Phase in effects our I of MDMA.
This approach, intended of successful generate acute in otherwise trial volunteers of as physiological possible to advance ASD. evidence development. racemic and to Basel, are pharmacokinetics is enrolling currently study initiate in as diagnosed profile clinical we MM-XXX, both MM-XXX development. designed molecules. and that preclinical data collaboration such Hospital healthy the
to our update. digital moving Lastly, medicine
outflow to development use refining our map but to has potential candidates. the digital facilitate product autonomic our other to is suite and program By a techniques strategy Our closely by adoption, to used activities. medicine drug model, behavioral core complemented access of of capture, and and and the
We for and perception-altering patients clinicians and substances. the and delivery of other the experience psychedelics improve outcomes of
applications devices sessions Our and the digital that of medicine activities definition separate during within intra-session activities Each session anticipate periods, devices. toward programs treatment digital primary not FDA's referred be contains X anticipate regulated program others during the treatment are be consists some will components, which medical which scope of referred we medical to and oriented a platform intra-session. as to between as will as of we clinical medicine underlying of
a our or payers.
Overall, along fictional the is delivery point-of-care projects products, and clearance to international of goal pleased providers intend are approval. authorities to that ultimate and digital to we pathway to very with develop with encourage engage medicine submission towards receive user The the medical the regulatory applications for adoption potential development we device overcome patients, guidance date. progress across regulatory FDA the to For other
leadership our of advance and on to execute As we the further continue our corporate we objectives, clinical strengthen key programs MindMed.
find as them prove of We brings We a addition sighting life by to guidance notified board's R. products meeting millions are disorders. our to like team. Corporate the approach strong experience to we valuable from executive help the evolution.
I from Board be of is who's ongoing our potential in perspectives ensuring him the the Pfizer and annual and Brigid Board its Insight believe we meeting people and of also of Chief including growth the I'd and acquired billion to over mix to our CFO we us his create by express of Board and Legal the will to S&P optimal billion. service and Officer, Celgene. she stage recent before is that that as the represents on adding as served endorsement experience as also acquisition have we previously serves It Sullivan, to our the commitment early organization. not excited the that to Dave's company Dave's by our valuable gratitude brain next insights Dave for potential $XX our their highlight $X.X of very for of Dave pharmaceutical annual of of reelection years the on extensive X Board. has have Jazz individuals will to and Pharmaceuticals Secretary. sciences the from nomination the addition the stand who an Makes very Seagen, years for excited also recently service industry, biopharmaceutical expertise. Mark well Pharmaceuticals XX refreshment of at of Mark's which of suffering of incredible have June, health public companies, built GW impact are the in brings by value.
I boardroom legal believe the Dave that for to progress the experience we Mark Gryska as organizations XXX MindMed's involvement company of in agreed the
brain change. deeply radically health time we the and realizing how is disorders, to treat transform to Now we committed are potential for that
over will Schond results. to financial turn now discuss Schond? call Greenway, the I that, our With our to CFO,
