Utyalo-mali luza kuxhasa umsebenzi wezorhwebo we-IGALMI™ ozayo e-US kunye nophuhliso lwemibhobho yonyango
ENTSHA HAVEN, Conn., April 19, 2022 (GLOBE NEWSWIRE) - BioXcel Therapeutics, Inc. (NASDAQ: BTAI) ("iNkampani" okanye "iBioXcel Therapeutics"), inkampani esebenzisa iindlela zobukrelekrele bokwenziwa ukuphuhlisa i-Commercial-stage biopharmacetical inkampani yokuguqula amayeza kwi-neuroscience kunye ne-immuno-oncology, namhlanje ibhengeze isivumelwano senkxaso-mali yeqhinga kunye ne-Oaktree Capital Management, LP ("Oaktree") kunye neemali ezilawulwa yi-Qatar Investment Authority ("QIA"). Ngaphantsi kwesivumelwano, i-Oaktree kunye ne-QIA iya kubonelela ukuya kuthi ga kwi-260 yezigidi zeerandi kwinkxaso-mali epheleleyo ukuxhasa imisebenzi yorhwebo yenkampani ye-IGALMI™ (dexmedetomidine) i-sublingual membrane.Ukongezelela, inkxaso-mali ijolise ekuxhaseni ukwanda kwe-BXCL501 iinzame zophuhliso lwezonyango, kubandakanywa inkqubo yeSigaba se-3 esibalulekileyo sonyango olunzima. yokuphazamiseka kwi-Alzheimer's disease (AD) izigulane, kunye ne-neuroscience eyongezelelweyo yenkampani kunye neprojekthi yeklinikhi ye-immuno-oncology.
Inkqubo yenkxaso-mali yexesha elide ikhokelwa ngu-Oaktree kwaye ibandakanya la macandelo alandelayo:
Phantsi kwesivumelwano, i-BioXcel Therapeutics iya kufumana imvume kuLawulo lokuTya kunye neDrugs yase-US (i-FDA) yokusetyenziswa kwemveliso yenkampani ye-BXCL501 kunyango oluqatha olunxulumene ne-schizophrenia okanye ukuphazamiseka kwe-bipolar I okanye II kubantu abadala. Ngomhla wesi-5 kuTshazimpuzi, ngo-2022, kulandela imvume ye-FDA ye-IGALMI.
Iimpawu eziphambili zenkxaso-mali zibandakanya umgca wetyala elinomdla kuphela kunye nexesha leminyaka emihlanu kunye nokuvunywa kwe-FDA kwe-BXCL501 yonyango olunzima olunxulumene nesifo se-Alzheimer's. , kubandakanywa i-BXCL701, i-oral oral innate immune activator yenkampani.Phantsi kwemimiselo yeSivumelwano seNzala yeMali yeNgeniso, i-Oaktree kunye ne-QIA ziya kufumana iintlawulo ze-Income Interest Financing ze-Tiered, ngokuxhomekeke kwi-cap yokubuyisela ubuninzi, kwiintengiso ze-IGALMI kunye nayo nayiphi na enye i-BXCL501 ezayo. iimveliso eUnited States.Ingeniso yenzala yenkxaso-mali isukela kwi-0.375% ukuya kwi-7.750% yentengiso yonyaka ye-IGALMI kunye nazo naziphi na ezinye iimveliso ze-BXCL501 zexesha elizayo e-US Ukuhlawulela izivumelwano zemali nzala yengeniso kwi-multiples eziphantsi kwiminyaka emithathu yokuqala.Inkxaso-mali yeqhinga ikwabandakanya utyalo-mali olunokubakho oluya kuthi ga kwi-5 yezigidi zeedola kwisitokhwe esiqhelekileyo senkampani, ekukhetheni i-Oaktree ne-QIA, ngokuxhomekeke kwisivumelwano setyala ngexabiso lesabelo ngasinye elilingana ne-10% yeprimiyamu ngaphezu kwepremiyamu ye-30% eya kubangela i-Oaktree. kunye/okanye i-QIA ukusebenzisa ukhetho Umthamo wexabiso ophakathi komthamo wosuku.
Emva kokuvalwa kwale ntengiselwano, kunye nebhalansi yemali yenkampani kunye nesicwangciso soshishino esilindelekileyo, iBioXcel Therapeutics ilindele ukuba nenkunzi yokusebenza yeminyaka emininzi.
"Ukulandela imvume yethu yamva nje ye-IGALMI kunye nesibhengezo senkxaso-mali yanamhlanje, asizange sibe kwindawo engcono yokuqonda umbono wethu wokuba yinkampani ehamba phambili yobukrelekrele bengqondo ye-neuroscience," utshilo uGqr. Vimal Mehta, i-CEO ye-BioXcel Therapeutics.“Siyavuya Ukomeleza isikhundla sethu semali ngokuyintloko ngenkunzi enganciphisiyo njengoko silungiselela ukuphehlelela i-IGALMI kwaye siqhubela phambili isicwangciso sethu sokukhulisa iphothifoliyo eneentsika ezintathu kule franchise, ebandakanya ukulandela izalathiso ezongezelelweyo, ukwandisa ukufikelela kwethu ngokwejografi kunye nokwandisa useto lwe-IGALMI lwezonyango luyafumaneka. .Okwangoku, sihlala sizimisele ukuqhubela phambili i-neuroscience yethu eyongezelelweyo kunye ne-immuno-oncology portfolio, kuquka i-BXCL502 kunye ne-BXCL701.
"Siyavuya ukusebenzisana ne-BioXcel Therapeutics ngeli xesha lizayo lokukhula okulindelweyo, ngakumbi ukuvunywa kwamva nje kunye nokuqaliswa kwezorhwebo okulindelweyo kwe-IGALMI njengonyango oluqatha olunxulunyaniswa ne-schizophrenia yabantu abadala okanye i-bipolar I okanye i-II disorder," utshilo u-Aman Kumar, Co. -Umphathi wePotfoliyo ye-Oaktree Life Sciences Lending. "Inkampani inendlela echulumancisayo, eqhutywa yi-AI ekufumaneni ichiza kunye nophuhliso, kwaye sijonge phambili ekuxhaseni ngenkxaso-mali yokwandiswa kwezi nzame kunye nokunceda inkampani ekuziseni unyango olutsha nolutsha kwizigulana ezisingqongileyo. Umhlaba."
Ulwazi olongezelelweyo malunga nenkxaso-mali ecwangcisiweyo icaciswe kwiFom ye-BioXcel Therapeutics' yeFomu 8-K yokufayilisha kunye neKhomishini yoKhuseleko noTshintsho lwase-US (SEC).
I-IGALMI (i-dexmedetomidine) ifilimu engaphantsi kweelwimi, eyayisaziwa ngokuba yi-BXCL501, i-proprietary yomlomo yokuchithwa kwefilimu yokwenziwa kwefilimu ye-dexmedetomidine eboniswe unyango olunzima lwezigulane ezine-schizophrenia okanye i-bipolar disorder phantsi kweliso lomboneleli wezempilo Ukuphazamiseka kwabantu abadala okunxulumene noHlobo lwe-I okanye lwe-II. Ukhuseleko kunye nokusebenza kakuhle kwe-IGALMI akuzange kusekwe ngaphaya kweeyure ze-24 emva kwe-dose yokuqala.Ngomhla we-5 ka-Epreli 2022, i-US Food and Drug Administration (FDA) ivume i-IGALMI ngokusekelwe kwidatha evela kwi-pivotal pivotal randomized, double-blind, placebo-controlled. , izilingo zeSigaba se-3 ezihambelanayo ezivavanya i-IGALMI yonyango olunzima Ukuphazamiseka okuhambelana ne-schizophrenia.SERENITY I) okanye i-bipolar I okanye i-II disorder (SERENITY II).
I-BioXcel Therapeutics, Inc. yinkampani ye-biopharmaceutical esebenzisa iindlela zobukrelekrele bokwenziwa ukuphuhlisa amayeza aguqulayo kwi-neuroscience kunye ne-immuno-oncology. Indlela yenkampani yokuvuselela ichiza kwakhona iphakamisa amayeza asele ekhona kunye/okanye abaviwa abaqinisekisiweyo bemveliso kunye nedatha enkulu kunye noomatshini bokuthengisa. ukufunda algorithms ukuchonga izalathi ezintsha zonyango.Imveliso yorhwebo yenkampani IGALMI (ephuhliswe njenge-BXCL501) yimveliso yefilimu ephantsi kwe-dexmedetomidine evunyiweyo yi-FDA yonyango olubukhali lokuphazamiseka okuhambelana ne-schizophrenia okanye i-bipolar I okanye i-II disorder kubantu abadala .BXCL501 ukuvandlakanywa kunyango olubukhali lwesifo se-Alzheimer, kwaye njengonyango lokuncedisa kwingxaki enkulu yokudakumba.Inkampani iphinda iphuhlise i-BXCL502, unyango olunokubakho kwixhala elingapheliyo kwi-dementia, kunye ne-BXCL701, uphando, olulawulwa ngomlomo lwe-immune activator ye-innate immune activator. ukunyangwa komhlaza wedlala lesinyi kunye namathumba aqinileyo aphucukileyo, anqandwayo okanye angaphathwanga inhibitors.Ngolwazi oluthe kratya, ndwendwela www.bioxceltherapeutics.com.
I-BofA Securities isebenze njengomcebisi wolwakhiwo oyedwa kwi-BioXcel Therapeutics kwaye uCooley LLP usebenze njengomcebisi wezomthetho kwi-BioXcel Therapeutics. USullivan & Cromwell LLP ukhonza njengomcebisi wezomthetho ku-Oaktree kwaye uShearman & Sterling LLP ukhonza njengomcebisi wezomthetho kwi-QIA.
I-Oaktree yifemu ekhokelayo yehlabathi yolawulo lotyalo-mali esebenza ngolunye utyalo-mali, ene-166 yeebhiliyoni zeerandi kwizinto eziphantsi kolawulo ukususela nge-31 kaDisemba, 2021. utyalo-mali.impahla kunye nezitokhwe ezidwelisiweyo.Inkampani inabasebenzi abangaphezu kwe-1,000 kunye neeofisi kwizixeko ze-20 emhlabeni jikelele.Ukufumana ulwazi oluthe kratya, tyelela iwebhusayithi ye-Oaktree kwi-http://www.oaktreecapital.com/.
I-Qatar Investment Authority ("QIA") yingxowa-mali yobutyebi ezimeleyo ye-State of Qatar.I-QIA yasekwa ngo-2005 ukuze ityale kwaye ilawule iNgxowa-mali enguVimba yeSizwe. I-QIA ityala imali kuluhlu olubanzi lweeklasi ze-asethi kunye neejografi kwaye isebenza namaziko akhokelayo kwihlabathi jikelele ukwakha ipotifoliyo eyohlukeneyo yehlabathi kunye nombono wexesha elide ukuhambisa imbuyekezo ezinzileyo kunye negalelo ekuchumeni kweQatar.Ukufumana ulwazi oluthe kratya malunga ne-QIA, nceda ndwendwela iwebhusayithi yayo www.qia.qa.
Olu shicilelo lweendaba lubandakanya "iingxelo ezijonge phambili" ngaphakathi kwentsingiselo yoMthetho woHlaziyo lweZibambiso eziBucala ze-1995. Iingxelo ezijonge phambili kule ngxelo yeendaba zibandakanya, kodwa azikhawulelwanga: ukuqaliswa kwezorhwebo kwe-IGALMI e-US ukuphatha ukuphazamiseka izigulane ezine-schizophrenia kunye ne-bipolar disorder;izicwangciso zophuhliso lweklinikhi, kubandakanywa uphuhliso oluqhubekayo lwenkampani ye-BXCL501, kunyango lwezigulane ezine-dementia Ukuphazamiseka kunye nonyango oluncedisayo kwingxaki enkulu yokudakumba;izicwangciso zokukhula kwenkampani kwixesha elizayo;inkxaso-mali elindelekileyo ngokwezivumelwano ne-Oaktree kunye ne-QIA kunye noqikelelo lwendlela yenqwelo-moya yenkampani kunye nokwanela okulindelekileyo kwemithombo yemali eyinkunzi yenkampani. “qhubeka,” “nenjongo,” “uyilo,” “injongo,” “ithagethi,” kunye namabinzana afanayo athetha Ekuchongeni iinkcazo ezijonge phambili.Ukongezelela, naziphi na iinkcazo okanye ulwazi, kuquka naziphi na iingqikelelo ezisisiseko, malunga nolindelo, iinkolelo, izicwangciso, uqikelelo. , iinjongo, ukusebenza okanye ezinye iimpawu zeziganeko ezizayo okanye iimeko, zikhangele phambili.Zonke iinkcazo ezikhangele phambili zisekelwe kwizinto ezilindelekileyo zenkampani kunye neengcinga ezahlukeneyo.Inkampani ikholelwa ukuba izinto ezilindelekileyo kunye neenkolelo zayo zinesiseko esifanelekileyo, kodwa zinombono ocacileyo. ukungaqiniseki ngokwendalo.Inkampani isenokungaphumeleli ngokwezinto ebizilindele, kwaye iinkolelo zayo zisenokungangqineki zichanekile.Iziphumo ezizezona zisenokwahluka ngokwezinto ezibonakalayo kwezo zichazwe okanye zichazwa yingxelo ejonge phambili njengesiphumo sezinto ezahlukeneyo ezibalulekileyo, kubandakanywa, kodwa ayiphelelanga: kwimfuno yeNkampani yemali eyongezelelweyo eyongezelelweyo kunye nokukwazi kwayo ukunyusa inkunzi ukuba iyafuneka;i-FDA kunye namagunya angaphandle afanayo Inkqubo yokwamkelwa yolawulo inde, idla ixesha, iyabiza kwaye ayiqikeleleki;inkampani inamava alinganiselweyo ekufumaneni amachiza kunye nophuhliso lwamachiza;abalawuli abanakuvuma okanye bavumelane nentelekelelo yenkampani, uqikelelo, izibalo, izigqibo okanye uhlalutyo, okanye kunokwenzeka Ukubaluleka kokutolika okanye ukulinganisa idatha ngeendlela ezahlukeneyo, ezinokuchaphazela ixabiso lenkqubo ethile, ukuvunywa okanye ukuthengiswa kwento ethile. umgqatswa wemveliso okanye imveliso kunye nenkampani ngokubanzi;inkampani ayinamava ekuthengiseni nasekuthengiseni amayeza kwaye ayinayo amava nge-IGALMI okanye i-BXCL501 yokuthengisa kunye namalungiselelo okuthengisa;I-IGALMI okanye abanye abaviwa bemveliso yeNkampani abanakuvunyelwa oogqirha okanye kuluntu jikelele lwezonyango;Inkampani ayinakukwazi ukufumana imvume yokuthengisa ye-BXCL501 eYurophu okanye kwezinye iindawo;Inkampani inokufuna imali eninzi eyongezelelweyo ukuphuhlisa nokuqhuba iimvavanyo zeklinikhi ezinxulumene nabaviwa bayo bemveliso kunye nokuxhasa imisebenzi yabo;iinkampani kufuneka zihambelane noluhlu olubanzi lwemimiselo esebenzayo;ukuguqulwa kwezempilo kunokuchaphazela kakubi impumelelo yezorhwebo yexesha elizayo.Ezi kunye nezinye izinto ezibalulekileyo zixutyushwa phantsi kwesihloko esithi "Izinto zoMngcipheko" kwiNgxelo yoNyaka kwiFomu ye-10-K yonyaka ophele ngo-Disemba 31, 2021, njengoko ezi zinto zingabonakala ngezikhathi ezithile. kwezinye iifayili zayo kunye noHlaziyo lwe-SEC, olufumaneka kwiwebhusayithi ye-SEC kwi-www.sec.gov.Ezi kunye nezinye izinto ezibalulekileyo zinokubangela ukuba iziphumo zangempela zihluke ngokubonakalayo kwizinto eziboniswe kwiingxelo ezijonge phambili kule ngxelo yeendaba. -iingxelo ezijongayo zimela uqikelelo lwabaphathi ukususela ngomhla wolu shicilelo lweendaba.Nangona inkampani ingakhetha ukuhlaziya iingxelo ezijonge phambili kwixesha elizayo, ngaphandle kokuba kufunwa ngumthetho, iyayilahla nayiphi na imbopheleleko yokwenza oko, nokuba Iziganeko ezilandelayo zibangela ukuba iimbono zethu zitshintshe.Ezi nkcazo zokujonga phambili akufanele zithathwe njengezimele iimbono zenkampani nangawuphi na umhla emva komhla wokukhutshwa kweendaba.
1 Inkxaso-mali ikwabandakanya izigunyaziso zokuthenga izabelo zesitokhwe esiqhelekileyo senkampani kunye nezigunyaziso zokuthenga iiyunithi zenkampani ephantsi kwe-LLC, njengoko kuchazwe ngokupheleleyo kwingxelo yangoku yeFomu 8-K eza kufakwa nge-19 ka-Epreli 2022.
Ixesha lokuposa: May-07-2022