Ukutshalwa kwezimali kuzosekela umsebenzi ozayo wezohwebo we-IGALMI™ e-US kanye nokuthuthukiswa kwamapayipi omtholampilo
I-NEW HAVEN, Conn., Ephreli 19, 2022 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (NASDAQ: BTAI) (“Inkampani” noma “i-BioXcel Therapeutics”), inkampani esebenzisa izindlela zobuhlakani bokwenziwa ukuthuthukisa i-biopharmaceutical yesiteji sezentengiso inkampani eguqula imithi ku-neuroscience kanye ne-immuno-oncology, namuhla imemezele isivumelwano sezimali samasu ne-Oaktree Capital Management, LP (“Oaktree”) kanye nezimali eziphethwe yiQatar Investment Authority (“QIA”).Ngaphansi kwesivumelwano, i-Oaktree ne-QIA izohlinzeka imali efinyelela ku-$260 million yokuxhasa imisebenzi yezentengiselwano ye-IGALMI™ (dexmedetomidine) yenkampani ye-sublingual membrane. Ngaphezu kwalokho, uxhaso lwezimali luhloselwe ukusekela ukunwetshwa kwemizamo yokuthuthukisa imitholampilo ye-BXCL501, okuhlanganisa nohlelo olubalulekile lweSigaba sesi-3 sokwelashwa okunamandla. yokuyaluza ezigulini ze-Alzheimer's (AD), kanye nephrojekthi yomtholampilo eyengeziwe ye-neuroscience kanye ne-immuno-oncology yenkampani.
Inqubo yesikhathi eside yokuxhasa ngezimali iholwa ngu-Oaktree futhi ihlanganisa lezi zingxenye ezilandelayo:
Ngaphansi kwesivumelwano, i-BioXcel Therapeutics izothola imvume evela kwa-US Food and Drug Administration (FDA) ukuze isebenzise umkhiqizo wenkampani i-BXCL501 ekwelapheni okubuhlungu okuhlobene nesifo sengqondo se-schizophrenia noma ukuphazamiseka kwe-bipolar I noma II kubantu abadala. Lesi simo sahlangatshezwana naso ngo- Ephreli 5, 2022, kulandela ukugunyazwa kwe-FDA kwe-IGALMI.
Izici ezibalulekile zoxhaso zifaka phakathi umugqa wesikweletu onenzalo kuphela onesikhathi seminyaka emihlanu kanye nokugunyazwa kwe-FDA kwe-BXCL501 yokwelashwa okunamandla okuhambisana nesifo i-Alzheimer's. , okuhlanganisa i-BXCL701, i-oral innate immune activator yenkampani.Ngaphansi kwemibandela Yesivumelwano Semali Yenzuzo Yenzuzo, u-Oaktree kanye ne-QIA bazothola izinkokhelo ze-Income Interest Financing, kuncike ekubuyiselweni okuphezulu, ekuthengisweni kwensalela kwe-IGALMI nanoma iyiphi enye i-BXCL501 yesikhathi esizayo. imikhiqizo e-United States.Amazinga emali yenzuzo yenzuzo etholwayo asukela ku-0.375% kuya ku-7.750% wokuthengiswa kwensalela yonyaka kwe-IGALMI kanye nanoma yimiphi eminye imikhiqizo ye-BXCL501 yesikhathi esizayo e-US Ukukhishwa kwezivumelwano zezimali zenzuzo engenayo ngokuphindaphindiwe okuphansi phakathi neminyaka emithathu yokuqala. kuhlanganisa nokutshalwa kwezimali okungaba khona kokulingana okungafika ku-$5 wezigidi kusitoko esivamile senkampani, ngokuzikhethela kwe-Oaktree ne-QIA, kuncike esivumelwaneni sesikweletu senani ngesheya ngalinye elilingana neprimiyamu engu-10% ngaphezu kweprimiyamu engu-30% engabangela i-Oaktree. kanye/noma i-QIA ukusebenzisa inketho Inani elimaphakathi elilinganiselwe levolumu yansuku zonke.
Ngemva kokuvalwa kwalokhu kuthengiselana, kanye nebhalansi yemali yenkampani kanye nohlelo lwebhizinisi olulindelekile, i-BioXcel Therapeutics ilindele ukuba nemali yokusebenza yeminyaka eminingi. Ukwenziwa ngokugcwele kwalokhu kuxhaswa kwezimali kuzonikeza inkampani indlela yokungena ukheshi ngo-2025.
“Ngemuva kokugunyazwa kwethu kwakamuva kwe-IGALMI kanye nesimemezelo sanamuhla sezimali, asikaze sibe sesimweni esingcono sokubona umbono wethu wokuba inkampani ehamba phambili yezobunhloli bokwenziwa kwe-neuroscience,” kusho uDkt. Vimal Mehta, oyi-CEO ye-BioXcel Therapeutics."Siyajabula Ukuqinisa isikhundla sethu semali ikakhulukazi ngemali engashintshisi njengoba silungiselela ukwethula i-IGALMI futhi siqhubekisela phambili isu lethu elinezinsika ezintathu zokukhulisa iphothifoliyo yale franchise, okuhlanganisa ukuphishekela izinkomba ezengeziwe, ukwandisa ukufinyelela kwethu kwendawo kanye nokwandisa ukulungiselelwa kwe-IGALMI yezokwelapha kuyatholakala. .Okwamanje, sisazibophezele ekuthuthukiseni iphothifoliyo yethu eyengeziwe ye-neuroscience kanye ne-immuno-oncology, okuhlanganisa i-BXCL502 ne-BXCL701.”
"Siyajabula ukusebenzisana ne-BioXcel Therapeutics ngalesi sikhathi esizayo sokukhula okulindelekile, ikakhulukazi ukugunyazwa kwakamuva kanye nokwethulwa kwezentengiselwano okulindelekile kwe-IGALMI njengendlela yokwelapha ebucayi ehambisana ne-schizophrenia yabantu abadala noma i-bipolar I noma II disorder," kusho u-Aman Kumar, Co. -Portfolio Manager of Oaktree Life Sciences Lending.” Le nkampani inendlela ethokozisayo, eqhutshwa yi-AI yokutholwa nokuthuthukiswa kwezidakamizwa, futhi sibheke ngabomvu ukuxhasa ngezimali ukunwetshwa kwale mizamo nokusiza inkampani ekuletheni izindlela zokwelapha ezintsha nezintsha ezigulini eziseduze. Umhlaba."
Ulwazi olwengeziwe mayelana nokuxhaswa ngezimali kwamasu lubekwe ekugcwaliseni Ifomu 8-K le-BioXcel Therapeutics ne-US Securities and Exchange Commission (SEC).
I-IGALMI (dexmedetomidine) ifilimu engaphansi kolimi, eyayaziwa ngokuthi i-BXCL501, iyifilimu ephathelene nomlomo encibilikisa ifilimu ye-dexmedetomidine ekhonjiswe ukwelashwa okunamandla kweziguli ezine-schizophrenia noma i-bipolar disorder ngaphansi kokuqondisa komhlinzeki wezempilo Ukuyaluza kwabantu abadala okuhlobene nesifo soHlobo I noma II. Ukuphepha nokusebenza ngempumelelo kwe-IGALMI akukasungulwa ngaphezu kwamahora angama-24 ngemuva komthamo wokuqala.Ngomhla zi-5 kuMbasa, 2022, i-US Food and Drug Administration (FDA) yagunyaza i-IGALMI ngokususelwe kudatha evela ezintweni ezimbili ezibalulekile ezingahleliwe, ezingaboni kabili, ezilawulwa yi-placebo. , izivivinyo zeSigaba sesi-3 zeqembu elihambisanayo ezihlola i-IGALMI yokwelashwa okunamandla Ukuyaluza okuhambisana ne-schizophrenia.SERENITY I) noma ukuphazamiseka kwe-bipolar I noma II (SERENITY II).
I-BioXcel Therapeutics, Inc. yinkampani ye-biopharmaceutical esebenzisa izindlela zobuhlakani bokwenziwa ukuze yakhe imithi eguqulayo ku-neuroscience kanye ne-immuno-oncology. Indlela yenkampani yokuvuselela izidakamizwa isebenzisa imithi ekhona egunyaziwe kanye/noma amakhandidethi omkhiqizo aqinisekiswe ngokomtholampilo kanye nedatha enkulu kanye nemishini yobunikazi. ukufunda ama-algorithms okukhomba izinkomba zokwelapha ezintsha.Umkhiqizo wezohwebo wenkampani i-IGALMI (othuthukiswe njenge-BXCL501) ukwakhiwa kwefilimu engaphansi kolimi lwe-dexmedetomidine egunyazwe i-FDA yokwelapha okubuhlungu okuhlobene nesifo schizophrenia noma i-bipolar I noma II disorder kubantu abadala .BXCL501 ihlolelwa ukwelashwa okunamandla kwesifo i-Alzheimer's, futhi njengokwelashwa okungeziwe kwesifo esikhulu sokucindezeleka.Inkampani futhi ithuthukisa i-BXCL502, ukwelapha okungaba khona kokukhathazeka okungapheli ekuwohlokeni komqondo, kanye ne-BXCL701, i-systemic innate immune activator ephenywayo, elawulwa ngomlomo. ukwelashwa komdlavuza wendlala yesinye kanye nezimila eziqinile ezithuthukile, ezingama-refractory noma ezingalashwa zokuhlola izindawo zokuhlola.Ukuze uthole ulwazi olwengeziwe, vakashela ku-www.bioxceltherapeutics.com.
I-BofA Securities isebenze njengoyedwa umeluleki wesakhiwo ku-BioXcel Therapeutics futhi u-Cooley LLP usebenze njengomeluleki wezomthetho ku-BioXcel Therapeutics.U-Sullivan & Cromwell LLP ukhonza njengomeluleki wezomthetho ku-Oaktree futhi u-Shearman & Sterling LLP ukhonza njengomeluleki wezomthetho ku-QIA.
I-Oaktree iyifemu ehamba phambili yokuphatha utshalomali emhlabeni wonke egxile kwezinye izimali ezitshaliwe, enempahla engaphansi kuka-$166 billion kusukela ngomhlaka-31 Disemba 2021. Le nkampani igcizelela indlela engosomathuba, egxile kakhulu enanini futhi elawulwa ubungozi yekhredithi, ukulingana kwangasese, kanye nezindawo ezithengiswayo. investing.assets and listed stocks.Inkampani inabasebenzi namahhovisi angaphezu kwe-1,000 emadolobheni angama-20 emhlabeni jikelele.Ukuze uthole ulwazi olwengeziwe, vakashela iwebhusayithi ye-Oaktree ku-http://www.oaktreecapital.com/.
I-Qatar Investment Authority (“QIA”) iyisikhwama somnotho esizimele seSifundazwe saseQatar.I-QIA yasungulwa ngo-2005 ukuze itshale futhi iphathe Isikhwama Sikazwelonke Sokulondolozwa Kwezimali.I-QIA ingenye yezikhwama zemali ezinkulu futhi ezisebenza kakhulu zomcebo wokubusa emhlabeni. I-QIA itshala imali ezinhlobonhlobo zezigaba zezimpahla kanye nezindawo futhi isebenza nezikhungo ezihamba phambili emhlabeni wonke ukwakha iphothifoliyo ehlukahlukene emhlabeni wonke enombono wesikhathi eside wokuletha izinzuzo ezisimeme futhi ibe negalelo ekuchumeni kweQatar. Ukuze uthole ulwazi olwengeziwe mayelana ne-QIA, sicela vakashela iwebhusayithi yayo ethi www.qia.qa.
Lokhu kukhululwa kwabezindaba kufaka phakathi "izitatimende ezibheke phambili" ngaphakathi kwencazelo ye-Private Securities Litigation Reform Act of 1995.Izitatimende ezibheke phambili kulokhu kukhululwa kwabezindaba zifaka, kodwa azikhawulelwe kulokhu: ukwethulwa kwezentengiso kwe-IGALMI e-US ukuze kuphathe ukuhlukumezeka ezweni. iziguli ezine-schizophrenia ne-bipolar disorder;izinhlelo zokuthuthukiswa komtholampilo, okuhlanganisa ukuthuthukiswa okuqhubekayo kwenkampani kwe-BXCL501, yokwelapha iziguli ezinokuwohloka komqondo Ukuguga futhi njengokwelashwa okuhlanganisayo kwesifo esikhulu sokucindezeleka;izinhlelo zokukhula zenkampani zesikhathi esizayo;ukuxhaswa ngezimali okulindelwe ngokuvumelana nezivumelwano ne-Oaktree kanye ne-QIA kanye nesilinganiso sendlela yemali yenkampani nokwanela okulindelekile kwezisetshenziswa zenhloko-dolobha yenkampani. Uma esetshenziswa lapha, amagama ahlanganisa “ukulindela,” “kuzokwenza,” “ukuhlela,” “okungenzeka,” “kungenzeka,” “qhubeka,” “hlosa,” “ukuklama,” “okuhlosiwe,” kanye nezinkulumo ezifanayo zisho Ekukhombeni izitatimende ezibheke phambili. , izinjongo, ukusebenza noma ezinye izici zezenzakalo zesikhathi esizayo noma izimo, zibheke phambili.Zonke izitatimende ezibheke phambili zisekelwe kulokho okulindelwe yinkampani kwamanje kanye nokuqagela okuhlukahlukene.Inkampani ikholelwa ukuthi lokho ekulindele nezinkolelo zayo kunesisekelo esizwakalayo, kodwa ukungaqiniseki ngokwemvelo.Inkampani ingase ingenzi ngokuvumelana nalokho ekulindele, futhi izinkolelo zayo zingase zingabi neqiniso.Imiphumela yangempela ingase yehluke kakhulu kuleyo echazwe noma eshiwo yilezo zitatimende ezibheke phambili ngenxa yezinto ezihlukahlukene ezibalulekile, okuhlanganisa, kodwa. kungagcini nje kulokhu: Isidingo seNkampani semali eyengeziwe eyengeziwe kanye nekhono layo lokukhulisa imali uma kudingeka;i-FDA kanye neziphathimandla ezifanayo zakwamanye amazwe Inqubo yokugunyaza yokulawula yinde, idla isikhathi, iyabiza futhi ayinakubikezelwa ngokwemvelo;inkampani inokuhlangenwe nakho okulinganiselwe ekutholeni izidakamizwa kanye nokuthuthukiswa kwezidakamizwa;abalawuli bangase bangavumi noma bavumelane nokuqagela kwenkampani, izilinganiso, izibalo, iziphetho noma ukuhlaziya, noma kungase Ukubaluleka kokuhumusha noma ukukala idatha ngezindlela ezahlukene, okungase kuthinte inani lohlelo oluthile, ukuvunyelwa noma ukuthengiswa kwento ethile. ikhandidethi lomkhiqizo noma umkhiqizo kanye nenkampani ngokujwayelekile;inkampani ayinaso isipiliyoni sokumaketha nokudayisa imithi futhi ayinaso isipiliyoni nge-IGALMI noma i-BXCL501 yokuthengisa nokuhlelwa kokumaketha;I-IGALMI noma eminye imikhiqizo yeNkampani ingase ingamukeleki kodokotela noma umphakathi jikelele wezokwelapha;Inkampani ingase ingakwazi ukuthola imvume yokumaketha ye-BXCL501 eYurophu noma kwezinye izindawo;Inkampani ingase idinge imali eyengeziwe eyengeziwe ukuze ithuthukise futhi iqhube izivivinyo Zomtholampilo ezihlobene nabakhandidethi bayo bemikhiqizo futhi isekele imisebenzi yabo;izinkampani kufanele zihambisane nemithethonqubo eminingi esebenzayo;izinguquko zokunakekelwa kwezempilo zingase zibe nomthelela omubi empumelelweni yezohwebo yesikhathi esizayo. Lezi nezinye izici ezibalulekile kuxoxwa ngazo ngaphansi kwesihloko esithi “Izici Zobungozi” Kumbiko wawo Wonyaka Wefomu 10-K wonyaka ophele ngomhla ka-31 Disemba 2021, njengoba lezi zici zingase zivele ngezikhathi ezithile. kokunye ukugcwaliswa kwayo ngezibuyekezo ze-SEC, ezitholakala kuwebhusayithi ye-SEC ethi www.sec.gov.Lezi kanye nezinye izici ezibalulekile zingabangela imiphumela yangempela yehluke kakhulu kuleyo ekhonjiswe izitatimende ezibheke phambili kulokhu kukhululwa kwabezindaba. -izitatimende ezibukekayo zimelela izilinganiso zabaphathi kusukela ngosuku lokukhishwa kwabezindaba.Nakuba inkampani ingase ikhethe ukubuyekeza izitatimende ezibheke phambili esikhathini esithile esizayo, ngaphandle uma kudingwa umthetho, iyasichitha isibopho sokwenza kanjalo, ngisho noma izehlakalo ezilandelayo zenza ukuthi imibono yethu ishintshe.Lezi zitatimende ezibheke phambili akufanele zithathwe njengezimelela imibono yenkampani nganoma iyiphi idethi engemuva kosuku lwalokhu kukhishwa kwabezindaba.
1 Ukuxhaswa ngezimali kuhlanganisa nezigunyazo zokuthenga amasheya esitoko esivamile senkampani kanye nezigunyazo zokuthenga amayunithi enkampani engaphansi kwe-LLC yenkampani, njengoba kuchazwe ngokugcwele embikweni wamanje weFomu 8-K ozofakwa ngo-April 19, 2022.
Isikhathi sokuthumela: May-07-2022