Investment inotsigira iri kuuya IGALMI ™ kutengeserana chiitiko muUS uye nekuwedzera kiriniki pombi yekuvandudza
NEW HAVEN, Conn., Kubvumbi 19, 2022 (GLOBE NEWSWIRE) - BioXcel Therapeutics, Inc. (NASDAQ: BTAI) (iyo "Company" kana "BioXcel Therapeutics"), kambani inoshandisa nzira dzehungwaru kugadzira Commercial-stage biopharmaceutical kambani inoshandura mishonga muuuroscience uye immuno-oncology, nhasi yakazivisa chibvumirano chemari neOaktree Capital Management, LP ("Oaktree") uye mari inotungamirwa neQatar Investment Authority ("QIA"). Pasi pechibvumirano, Oaktree neQIA ichapa inosvika madhora mazana maviri nemakumi matanhatu emamiriyoni emari yekutsigira mabasa ekutengesa ekambani yeIGALMI™ (dexmedetomidine) sublingual membrane. Pamusoro pezvo, mari iyi inoitirwa kutsigira kuwedzera kweBXCL501 budiriro yekiriniki yekuedza, kusanganisira yakakosha Phase 3 chirongwa chekurapa kwakanyanya. yeagitation muAlzheimer's disease (AD) varwere, pamwe nekambani yekuwedzera neuroscience uye immuno-oncology Clinical project.
Iyo yenguva refu yehurongwa hwekuita mari inotungamirwa naOaktree uye inosanganisira zvinotevera zvikamu:
Pasi pechibvumirano ichi, BioXcel Therapeutics ichawana mvumo kubva kuUS Food and Drug Administration (FDA) yekushandisa chigadzirwa chekambani cheBXCL501 mukurapa kwakanyanya kwekushushikana kunoenderana neschizophrenia kana bipolar I kana II kusagadzikana muvakuru. Kubvumbi 5, 2022, zvichitevera kubvumidzwa kweFDA kweIGALMI.
Mamiriro akakosha emari anosanganisira mutsara wechikwereti chenguva yemakore mashanu uye mvumo yeFDA yeBXCL501 yekurapa kwakanyanya kwekushushikana kunoenderana nechirwere cheAlzheimer. , kusanganisira BXCL701, yekambani yekuferefeta oral innate immune activator.Pasi pezvirevo zveIncome Interest Financing Agreement, Oaktree neQIA vachawana tiered Income Interest Financing mubhadharo, zvichienderana nepamusoro kudzoka kepu, pakutengesa mambure kweIGALMI uye chero ramangwana reBXCL501 zvigadzirwa muUnited States.Imari yemubereko yekubhadhara mitengo inotangira pa 0.375% kusvika 7.750% yegore negore yekutengesa kweIGALMI uye chero zvimwe zvemangwana BXCL501 zvigadzirwa muUS Kudzikinura kwezvibvumirano zvemhindu mari yekuwana mari pazvizhinji zvakaderera mukati memakore matatu ekutanga.The Strategic financing. zvinosanganisirawo mukana wekudyara mari inosvika 5 miriyoni emadhora muzvitoro zvakajairika zvekambani, pasarudzo yeOaktree neQIA, zvichienderana nechibvumirano chechikwereti pamutengo wega wega wakaenzana negumi muzana rekutanga pamusoro peiyo 30% yekutanga iyo inogona kukonzera Oaktree. uye/kana QIA kushandisa sarudzo Iyo yemazuva ese vhoriyamu-yakayerwa avhareji mutengo.
Zvichitevera kuvharwa kwekutengeserana uku, pamwe chete nemari yekambani pamwe nehurongwa hwebhizinesi hunotarisirwa, BioXcel Therapeutics inotarisira kuve nemari yekushanda kwemakore akawanda. Kuitwa kwemari iyi kuchapa kambani nzira yekumhanya muna 2025.
"Tichitevera kubvumidza kwatakaita nguva pfupi yadarika IGALMI uye chiziviso chemari chanhasi, hatisati tambove munzvimbo iri nani yekuona chiono chedu chekuva kambani inotungamira yehungwaru hwehungwaru," akadaro Dr. Vimal Mehta, CEO weBioXcel Therapeutics."Tinofara Kusimbisa chinzvimbo chedu chemari kunyanya nemari isiri-dilutive sezvatiri kugadzirira kutanga IGALMI uye kusimudzira nzira yedu yekukura kwembiru nhatu dzefranchise iyi, iyo inosanganisira kutsvaga zvimwe zviratidzo, kuwedzera nzvimbo yedu yekusvika uye kuwedzera mamiriro ekurapa IGALMI aripo. .Zvichakadaro, tinoramba takazvipira kusimudzira yedu yekuwedzera neuroscience uye immuno-oncology portfolio, kusanganisira BXCL502 uye BXCL701.
"Tinofara kubatana neBioXcel Therapeutics munguva ino iri kuuya yekukura kunotarisirwa, kunyanya kubvumidzwa uye kufungidzirwa kwekutengesa kweIGALMI semushonga wakakomba wekushushikana kunoenderana nevakuru schizophrenia kana bipolar I kana II chirwere," akadaro Aman Kumar, Co. -Portfolio Maneja weOaktree Life Sciences Lending. "Kambani ine nzira inonakidza, inotungamirwa neAI yekuwana zvinodhaka nekusimudzira, uye isu tinotarisira kupa mari yekuwedzera kwekuedza uku uye kubatsira kambani kuunza kurapa kutsva uye hunyanzvi kuvarwere varipo. nyika."
Rumwe ruzivo maererano nehurongwa hwekubhadhara mari hwakanyorwa muBioXcel Therapeutics 'Fomu 8-K faira neUS Securities and Exchange Commission (SEC).
IGALMI (dexmedetomidine) sublingual film, yaimbozivikanwa seBXCL501, ndeye proprietary oral dissolving film formulation ye dexmedetomidine inoratidzwa pakurapa kwakanyanya kwevarwere vane schizophrenia kana bipolar disorder pasi pekutariswa kwehutano hwehutano. Kuchengetedzeka uye kushanda kweIGALMI hakuna kusimbiswa kupfuura maawa makumi maviri nemana mushure mekutanga dosi. Musi wa5 Kubvumbi, 2022, iyo US Food and Drug Administration (FDA) yakabvumidza IGALMI zvichibva pane data kubva kune mbiri yakakosha randomized, kaviri-mapofu, placebo-inodzorwa. , parallel-group Phase 3 miedzo yekuongorora IGALMI yekurapa kwakanyanya Kushungurudza kunobatanidza neschizophrenia.SERENITY I) kana bipolar I kana II chirwere (SERENITY II).
BioXcel Therapeutics, Inc. ikambani yebiopharmaceutical inoshandisa nzira dzehungwaru kugadzira mishonga inosandura mune neuroscience uye immuno-oncology. Nzira yekambani yekuvandudza mishonga yemishonga inokwirisa mishonga iripo yakatenderwa uye/kana vakabvumidzwa nekiriniki yezvigadzirwa pamwe nedata hombe nemichina yemuridzi. kudzidza maalgorithms ekuona zviratidzo zvitsva zvekurapa.Chigadzirwa chekambani chekutengesa IGALMI (yakagadzirwa seBXCL501) ndeye proprietary dexmedetomidine sublingual film formulation yakabvumidzwa neFDA for acute treatment of agitation associated with schizophrenia kana bipolar I kana II disorder muvanhu vakuru .BXCL501 ichiongororwa kurapwa kwakanyanya kwechirwere cheAlzheimer, uye sechigadziriso chekurapa kwekuora mwoyo kukuru.Kambani iri zvakare kugadzira BXCL502, inogona kurapwa kusingaperi kusagadzikana mudementia, uye BXCL701, yekuferefeta, inotungamirwa nemuromo systemic innate immune activator, ye kurapwa kwekenza yeprostate ine hutsinye uye mapundu akasimba akasimba, ayo ari refractory kana asina kurapwa checkpoint inhibitors.Kuti uwane rumwe ruzivo, shanya www.bioxceltherapeutics.com.
BofA Securities yakashanda sechipangamazano ega kuBioXcel Therapeutics uye Cooley LLP akashanda sechipangamazano wezvemutemo kuBioXcel Therapeutics.Sullivan & Cromwell LLP inyanzvi yezvemitemo kuna Oaktree uye Shearman & Sterling LLP ari kushanda segweta remutemo kuQIA.
Oaktree ikambani inotungamira yepasirese yekudyara mari inoshanda mune dzimwe nzira dzekudyara, ine mabhiriyoni gumi nematanhatu emadhora muzvinhu zviri pasi pemanejimendi kubva muna Zvita 31, 2021. investing.assets and listed stocks
Qatar Investment Authority ("QIA") ndiyo homwe yehupfumi yeNyika yeQatar.QIA yakavambwa muna 2005 kuti idyare uye itarise homwe yeNational Reserve Fund.QIA ndeimwe yemari huru uye inoshanda zvakanyanya pasi rose. QIA inodyara mumhando dzakasiyana-siyana dzemakirasi easset uye geographies uye inoshanda nemasangano anotungamira pasi rose kuvaka dhizaini yepasi rose ine muono wenguva refu yekuunza kudzoka kwakasimba uye kubatsira mukubudirira kweQatar. Kuti uwane rumwe ruzivo nezve QIA, ndapota. shanyira webhusaiti yayo www.qia.qa.
Kuburitswa kwenhau uku kunosanganisira "zvirevo zvinotarisisa kumberi" mukati mezvinoreva Private Securities Litigation Reform Act of 1995.Mashoko anotarisa mberi mune ino nhepfenyuro anosanganisira, asi haana kugumira ku: kushambadzira kwe IGALMI kuUS kurapa kusagadzikana mu. varwere vane schizophrenia uye bipolar disorder;zvirongwa zvekuvandudza kwekiriniki, kusanganisira kuenderera mberi kwekambani kusimudzira kweBXCL501, yekurapa varwere vane dementia Agitation uye seadjunctive kurapa kwekuora mwoyo kukuru;zvirongwa zvekukura kwekambani mune ramangwana;mari yaitarisirwa maererano nezvibvumirano neOaktree neQIA uye inofungidzirwa kuti nzira yekufambisa mari yekambani uye inotarisirwa kukwana kwezviwanikwa zvekambani. Kana akashandiswa pano, mazwi anosanganisira "kufungidzira," "kuda," "kuronga," "zvinogona," "zvingadaro," "enderera," "vavarira," "kugadzira," "chinangwa," uye mazwi akafanana anoreva Mukuziva zvirevo zvinotarisa mberi. Pamusoro pezvo, chero zvirevo kana ruzivo, kusanganisira chero fungidziro dzipi nedzipi, maererano nezvinotarisirwa, zvinotendwa, zvirongwa, kufanotaura. , zvinangwa, kushanda kana mamwe maitiro ezviitiko zvemunguva yemberi kana mamiriro ezvinhu, zvinotarisa mberi.Zvose zvinotarisa-zvinotaridzirwa zvinobva pane zvinotarisirwa nekambani iye zvino uye mafungiro akasiyana-siyana.Kambani inotenda kuti zvinotarisirwa uye zvinotendwa zvine chikonzero chakanaka, asi ndizvo. zvisikwa zvisinganyatsozivikanwi.Kambani inogona kusararama maererano nezvainotarisira, uye kutenda kwayo kungasaratidza kuva kwechokwadi.Migumisiro chaiyo inogona kusiyana zvikuru kubva kune inotsanangurwa kana kutaurwa nemashoko akadaro anotarisa mberi semugumisiro wezvinhu zvakakosha zvakasiyana-siyana, kusanganisira, asi. kwete kugumira kune: Kudiwa kweKambani yekuwedzera mari yakawanda uye kugona kwayo kukwidza mari kana zvichidikanwa;iyo FDA nezvimwe zviremera zvekunze zvakada kufanana.iyo kambani ine ruzivo rushoma mukutsvaga zvinodhaka nekuvandudza zvinodhaka;Vatongi vanogona kusagamuchira kana kubvumirana nemafungiro ekambani, fungidziro, kuverenga, mhedziso kana ongororo, kana kungave Kukosha kwekududzira kana kuyera iyo data nenzira dzakasiyana, izvo zvinogona kukanganisa kukosha kwechimwe chirongwa, kubvumidzwa kana kushambadzira kwechimwe chinhu. chigadzirwa mumiriri kana chigadzirwa uye kambani zvakazara;kambani haina ruzivo mukushambadzira nekutengesa mishonga uye haina ruzivo neIGALMI kana BXCL501 kutengesa uye kushambadzira zvirongwa;IGALMI kana kuti zvimwe zvigadzirwa zveKambani zvingave zvisingagamuchirwe kuvarapi kana nharaunda yezvekurapa;Kambani inogona kusakwanisa kuwana mvumo yekushambadzira yeBXCL501 muEurope kana mamwe matunhu;Kambani inogona kuda mari yakawedzerwa yekuvandudza uye kuitisa Miedzo yeKliniki ine chekuita nevanoda chigadzirwa uye kutsigira mashandiro avo;makambani anofanirwa kutevedzera huwandu hwakawanda hwemitemo inoshanda;kugadziriswa kwehutano kunogona kukanganisa kubudirira mune ramangwana mune zvekutengeserana.Izvi nezvimwe zvinhu zvakakosha zvinokurukurwa pasi pemusoro unoti "Risk Factors" muChirevo chegore reFomu 10-K yegore rakapera December 31, 2021, sezvo zvinhu izvi zvingaonekwa nguva nenguva. mune mamwe mafirita ayo ane SEC Updates, anowanikwa pawebsite yeSEC pa www.sec.gov.Izvi nezvimwe zvinhu zvakakosha zvinogona kuita kuti mhedzisiro chaiyo isiyane kubva kune inoratidzwa nekutaura-kumberi mune ino kuburitswa kwenhau. -kutarisa zvirevo zvinomiririra fungidziro yevatungamiri kubva pazuva rekuburitswa kwenhau.Kunyange zvazvo kambani ingasarudza kuvandudza zvirevo zvinotarisa mberi pane imwe nguva mune ramangwana, kunze kwekunge zvichidiwa nemutemo, inoramba chero chisungo chekuita kudaro, kunyange kana zviitiko zvinotevera zvinokonzeresa kuti maonero edu achinje.Izvi zvinyorwa zvinotarisa mberi hazvifanirwe kutorwa sekumiririra maonero ekambani pane chero zuva rapfuura zuva rekuburitswa kwenhau.
1 Mari iyi inosanganisirawo mawaranti ekutenga migove yekambani yakajairika uye mawarandi ekutenga mayunitsi ekambani inotsigira LLC, sekutsanangurwa kwakazara mumushumo wazvino weFomu 8-K ichaiswa muna Kubvumbi 19, 2022.
Nguva yekutumira: May-07-2022