our call Thank afternoon, you, Mark, good and today. you for joining everyone. Thank
of we're a neuroscience candidates joining development. clinical-stage you candidate. for II includes novel, For diverse nonsystemic the these multiple who a us product each is those And are III Phase of company and a that pipeline in neurocircuitry-focused with first product Phase time,
Our of with unsatisfied care and flashes. large programs medical lead leave X clinical target potentially fear menopausal with affected hot markets the profound social of standards development and the individuals disorder, by specifically individuals anxiety of effects serious depression anxiety stale life-threatening disruptive the associated with needs, and of millions that impacts
to care decades, uptake very medications anchored are require pioneering to side candidates the in effects oral called systemic that, large safety been mission concerns, and efficacy. action indications, change And For our of neuroscience and standard a prolonged is new bundle that of limited pherines. our these worrisome of with that these class change with and our of and onset associated clinical-stage in markets, product has
been flashes safety achieve Distinguished our for pherine on brain of so candidates depression studies requiring by completed are PHXX we've action the for and rapidly activate effects clinical date. direct lead profiles systemic all to intentionally favorably neural anxiety, systemic unique social in or to medications from in therapeutic neurons to the with without do observed hot our oral as differentiated itruvone for product uptake have to FDA, that fasedienol menopausal neuroactive all sprays and circuits nasal formulated approved nose-to-brain pherines,
without for trial whole positive the II to achieve or us due brain. into they historic is through differences located do multiple III in well involving circuitry a results different use fundamental clinical also the that the even to regions medical the and body of trials the activate enabled portal as reported in exploratory travel again, acute conditions, nose epithelium a social and dysphoric having premenstrual have disorder hot Pherines of with the olfactory impact key Those mental year as impairment brain that neural in neurons anxiety to to that SAD, or psychomotor patients see fatigue. last disorder, treatment depressive menopausal success disorder, flashes, Phase we in Phase major and
investigational of Our III top our focused PALISADE SAD. pherine of U.S. neuroscience the nasal XX% medication FDA which acute program of program no market is vast large, team approved lead in for and registration-directed that priority, treatment is a spray majority the fasedienol. underserved and U.S. Phase our of on for the SAD, the There's growing acute for are which our is That adults treatment in capital our affects the very
is noted many goal principle to times, I that. our change As
to the initiate Last this replicating this III Phase positive PALISADE-X. study objective of of PALISADE-X previously we trial these III we study that exploratory study Phase will That treatment Phase will guided. the study. designed to III an as ever dose year second as Phase reported for study have the repeat out PALISADE-X year, on same next objective in the and III Enrollment similarly of trial, studies with we Both track another replicating our positive PALISADE-X as of the SAD. results Earlier the year, the PALISADE-X the success drug read design fasedienol, year. trial of well we III on Phase the Phase track, also a and with PALISADE-X same PALISADE-X, is our in of first are of IIa launched from half candidate as of acute
establish in the of of U.S. with potential We believe evidence a support of either PALISADE-X successful, together fasedienol or PALISADE-X, substantial effectiveness the may if and PALISADE-X,
over the to submission of anxiety many range the as depression acute as sometimes lives sometimes SAD. even daily years humiliation with judgment, of if of ever embarrassment, FDA, new unfortunately serious social Application by to a and the affect potentially establish of to and and first situations performance and fasedienol approved, FDA-approved and whose needed treatment suicide. option Drug fear be their which, in and demand life-threatening could on New lead treatment used A Americans wide millions potential
for for acute track achieve with SAD and put well necessary PALISADE fasedienol stockholders. potential the what's our to position our important III patients to for and valuable us again, and on of for Phase do priority, the So are a in funded top and we that to goal U.S. program treatment registration-directed very is our
-- and U.S., indications, of other is what MDD in seen from II PHXX of further flashes which in and we've positive nonsystemic both for are hormone-free as staging X for the nonsystemic confidence in hot pherine nonsystemic depression exploratory for Phase far our itruvone on in has efficacy pharmacological seen in in results market these so care driving and Phase candidates standards stale safety building lives. potential flashes each treatment IIa our We each these alternative. II product to also clinical-stage and programs to lead Phase the large and development studies We've improve hot of of menopausal
for itruvone to suffer as that Itruvone their for a fundamentally MDD distinguished IIb and relief as treatment we're not depression symptoms which or currently for Itruvone stand-alone a disorder. potential available in effects, treatment the have help that's and product from for completed novel its depressive associated major holds preparing And the development gain from swiftly side potential options. potential with favorable individuals effects the emerge systemic is gain by with date, Phase without and been who is distinct side of of U.S. candidate sexual to in unwanted abuse. been profile safety to strategizing many example, studies observed weight a
in for Phase to further PHXX development the multiple in product but U.S. well the pherine II PHXX holds hot hormone-free nonsystemic U.S. for nonclinical of MDD IND high have to to flashes. hot menopausal women our that -- our that notably enable ongoing to affect health finally, Similar II to Phase clinical women's millions of accomplished aims of menopausal we development conditions, do PHXX, flashes, as for our enable And commercial U.S., product world. in what medical program and for most the promise for itruvone menopausal candidate around flashes considerable further
therapies. affected of would millions We are by treatment novel flashes menopausal current are a nonsystemic who hot the women confident hormone-free option over that prefer
CFO, financial quarter. the Cindy? the With Cindy, that, our some I'll summarize turn call from last of the to highlights to over
