E kākoʻo ka hoʻopukapuka kālā i ka hana pāʻoihana IGALMI ™ e hiki mai ana ma US a me ka hoʻomohala hou ʻana i ka pipeline lapaʻau
NEW HAVEN, Conn., ʻApelila 19, 2022 (GLOBE NEWSWIRE) - BioXcel Therapeutics, Inc. (NASDAQ: BTAI) (ka "Company" a i ʻole "BioXcel Therapeutics"), he hui e hoʻohana ana i nā ʻano hana akamai no ka hoʻomohala ʻana i ka biopharmaceutical pae Kūʻai. ʻO ka hui e hoʻololi i nā lāʻau lapaʻau i ka neuroscience a me ka immuno-oncology, i kēia lā hoʻolaha i kahi ʻaelike kālā hoʻolālā me Oaktree Capital Management, LP ("Oaktree") a me nā kālā i mālama ʻia e ka Qatar Investment Authority ("QIA"). a hiki i $260 miliona ka huina kālā no ke kākoʻo ʻana i nā hana pāʻoihana o ka membrane sublingual IGALMI™ (dexmedetomidine) o ka hui. ʻO ka hoʻonāukiuki i nā maʻi o Alzheimer (AD), a me ka papahana neuroscience hou a me ka immuno-oncology.
Ke alakaʻi ʻia nei ke kaʻina hana kālā hoʻolālā lōʻihi e Oaktree a loaʻa nā ʻāpana aʻe:
Ma lalo o ka ʻaelike, e loaʻa iā BioXcel Therapeutics ka ʻae ʻia mai ka US Food and Drug Administration (FDA) no ka hoʻohana ʻana i ka huahana BXCL501 o ka hui no ka mālama ʻana i ka hoʻonāukiuki e pili ana i ka maʻi schizophrenia a i ʻole maʻi bipolar I a i ʻole II i nā pākeke. ʻApelila 5, 2022, ma hope o ka ʻae ʻana o FDA i ka IGALMI.
ʻO nā hiʻohiʻona koʻikoʻi o ka hoʻopukapuka kālā ʻana he laina hōʻaiʻē manawaleʻa wale nō me ka ʻelima mau makahiki a me ka ʻae ʻana o FDA iā BXCL501 no ka mālama ʻana i ka hoʻonāukiuki e pili ana i ka maʻi o Alzheimer. , me BXCL701, ka hui oral innate immune activator. nā huahana ma ʻAmelika Hui Pū ʻIa. Loaʻa nā kumukūʻai hoʻolimalima kālā loaʻa mai 0.375% a i 7.750% o nā kūʻai ʻupena makahiki o IGALMI a me nā huahana BXCL501 e hiki mai ana i ka US Hoʻolaʻa ʻana i nā ʻaelike hoʻolimalima ukupanee ma nā helu haʻahaʻa i loko o nā makahiki ʻekolu. e komo pū ana me ka hoʻokomo kālā kūpono a hiki i $ 5 miliona ma ke kumukūʻai maʻamau o ka hui, ma ke koho ʻana o Oaktree a me QIA, ma lalo o kahi ʻaelike hōʻaiʻē ma ke kumukūʻai o kēlā me kēia mahele e like me ka 10% premium ma luna o ka 30% premium e hiki ai ke kumu o Oaktree a / a i ʻole QIA e hoʻohana i ke koho ʻO ke kumu kūʻai maʻamau i kēlā me kēia lā.
Ma hope o ka pau ʻana o kēia hana, me ke koena kālā o ka hui a me ka hoʻolālā ʻoihana i manaʻo ʻia, manaʻo ʻo BioXcel Therapeutics e loaʻa i kahi kumulāʻau hana nui makahiki.
"Ma hope o kā mākou ʻae ʻia ʻana o IGALMI a me ka hoʻolaha hoʻolaha kālā i kēia lā, ʻaʻole mākou i ʻoi aku ka maikaʻi o ka hoʻokō ʻana i kā mākou ʻike ʻana i ke alakaʻi ʻana i ka hui neuroscience artificial intelligence," wahi a Kauka Vimal Mehta, Luna Nui o BioXcel Therapeutics."ʻOliʻoli mākou i ka hoʻoikaika ʻana i kā mākou kūlana kālā me ke kapikala non-dilutive ʻoiai mākou e hoʻomākaukau ai e hoʻomaka i ka IGALMI a hoʻomohala i kā mākou hoʻolālā hoʻomohala kōpili ʻekolu pou no kēia franchise, ʻo ia hoʻi ka ʻimi ʻana i nā hōʻailona hou aʻe, ka hoʻonui ʻana i kā mākou pae ʻāina a me ka hoʻonui ʻana i ka hoʻonohonoho ʻana o IGALMI. .I kēia manawa, hoʻomau mākou i ka hoʻoikaika ʻana i kā mākou neuroscience hou a me immuno-oncology portfolio, me BXCL502 a me BXCL701.
"ʻOliʻoli mākou i ka hui pū ʻana me BioXcel Therapeutics i kēia wā e hiki mai ana o ka ulu ʻana i manaʻo ʻia, ʻoi aku ka ʻae ʻana a me ka hoʻomaka ʻana o ka hoʻolaha pāʻoihana o IGALMI ma ke ʻano he lāʻau koʻikoʻi no ka hoʻonāukiuki e pili ana i ka maʻi schizophrenia makua a i ʻole ka maʻi bipolar I a i ʻole II," wahi a Aman Kumar, Co -Portfolio Manager o Oaktree Life Sciences Lending. ka honua.
Hōʻike ʻia nā ʻike hou aʻe e pili ana i ke kālā kālā ma ka BioXcel Therapeutics 'Form 8-K filing me ka US Securities and Exchange Commission (SEC).
ʻO IGALMI (dexmedetomidine) kiʻiʻoniʻoni sublingual, i kapa mua ʻia ʻo BXCL501, he kiʻiʻoniʻoni hoʻoheheʻe waha o ka dexmedetomidine i hōʻike ʻia no ka mālama ʻana i nā maʻi me ka schizophrenia a i ʻole ka maʻi bipolar ma lalo o ka mākaʻikaʻi ʻana o kahi mea mālama ola. ʻAʻole i hoʻokumu ʻia ka palekana a me ka maikaʻi o IGALMI ma mua o 24 mau hola ma hope o ka hoʻopaʻa mua ʻana. Ma ʻApelila 5, 2022, ua ʻae ka US Food and Drug Administration (FDA) i ka IGALMI ma muli o ka ʻikepili mai ʻelua pivotal randomized, double-blind, placebo-controlled , Nā ho'āʻo ʻana o ka Phase 3 pūʻulu parallel e loiloi ana i ka IGALMI no ka mālama ʻana i ka maʻi ʻino.
ʻO BioXcel Therapeutics, Inc. he hui biopharmaceutical e hoʻohana ana i nā ala hana akamai e hoʻomohala i nā lāʻau lapaʻau transformative i ka neuroscience a me ka immuno-oncology. aʻo algorithms e ike hou therapeutic indicators.Ka hui 'oihana kalepa IGALMI (i kūkulu 'ia e like me BXCL501) mea he proprietary dexmedetomidine sublingual film formulation aponoia e ka FDA no ka acute lapaʻau o ka agitation pili me schizophrenia a bipolar I a II maʻi i loko o nā mākua .BXCL501 no hoi. ke loiloi ʻia nei no ka mālama ʻana i ka maʻi o Alzheimer, a ma ke ʻano he lāʻau hoʻohui no ka maʻi depressive nui. Ke hoʻomohala nei ka ʻoihana i ka BXCL502, kahi lapaʻau kūpono no ka hopohopo mau i ka dementia, a me BXCL701, kahi noiʻi, waha i lawelawe ʻia systemic innate immune activator, no ka ka mālama ʻana i ka maʻi maʻi prostate a me nā maʻi maʻi paʻa kiʻekiʻe, he mea hoʻopaʻa ʻole a mālama ʻole ʻia. No ka ʻike hou aku, e kipa www.bioxceltherapeutics.com.
Ua hana ʻo BofA Securities ma ke ʻano he ʻōlelo aʻoaʻo hoʻokahi no BioXcel Therapeutics a ʻo Cooley LLP i hana ma ke ʻano he ʻōlelo aʻoaʻo kānāwai no BioXcel Therapeutics. ʻO Sullivan & Cromwell LLP e lawelawe ana ma ke ʻano he loio no Oaktree a ʻo Shearman & Sterling LLP ke lawelawe nei ma ke ʻano he loio no QIA.
ʻO Oaktree kahi ʻoihana hoʻokele waiwai hoʻokele honua e ʻike nui ana i nā hoʻopukapuka ʻē aʻe, me $166 biliona waiwai ma lalo o ka hoʻokele ʻana a hiki i Dekemaba 31, 2021. Hoʻokumu ka ʻoihana i kahi manawa kūpono, waiwai a me ka hoʻokele pilikia i ka hōʻaiʻē, ke kaulike pilikino, a me ka waiwai paʻa. investing.assets and listed stocks.He 1,000 oi aku ka nui o na limahana a me na keena o ka hui ma na kulanakauhale he 20 a puni ka honua.
ʻO ka Qatar Investment Authority ("QIA") ka waihona waiwai nui o ka Moku'āina o Qatar. Ua hoʻokumu ʻia ʻo QIA i ka makahiki 2005 e hoʻokomo a mālama i ka National Reserve Fund. Hoʻokomo kālā ʻo QIA i nā papa waiwai a me nā ʻāina āpau a hana pū me nā ʻoihana alakaʻi a puni ka honua e kūkulu i kahi portfolio diversified honua me kahi ʻike lōʻihi e hāʻawi i nā hoʻihoʻi mau a kōkua i ka pōmaikaʻi o Qatar. No ka ʻike hou aku e pili ana iā QIA, e ʻoluʻolu e kipa i kāna pūnaewele www.qia.qa.
ʻO kēia hoʻokuʻu paʻi e pili ana i "nā ʻōlelo i mua" i loko o ke ʻano o ka Private Securities Litigation Reform Act o 1995. ʻO nā ʻōlelo e nānā i mua i loko o kēia hoʻopuka paʻi e pili ana, akā ʻaʻole i kaupalena ʻia: nā maʻi me ka schizophrenia a me ka maʻi bipolar;nā hoʻolālā hoʻomohala lapaʻau, me ka hoʻomohala mau ʻana o ka hui ʻo BXCL501, no ka mālama ʻana i nā maʻi me ka Dementia Agitation a ma ke ʻano he lāʻau hoʻohui no ka maʻi depressive nui;nā papahana ulu o ka hui e hiki mai ana;i manaʻo ʻia ka loaʻa kālā ma muli o nā ʻaelike me Oaktree a me QIA a me ke alahele kālā i manaʻo ʻia e ka hui a me ka manaʻo kūpono o nā kumu waiwai o ka hui. "hoʻomau," "manaʻo," "hoʻolālā," "pahuhopu," a me nā ʻōlelo like ʻole i ka ʻike ʻana i nā ʻōlelo e nānā ana i mua. , nā pahuhopu, ka hana a i ʻole nā hiʻohiʻona ʻē aʻe o nā hanana a i ʻole nā kūlana e hiki mai ana, ke nānā nei i mua. ʻO nā ʻōlelo a pau i mua e pili ana i nā manaʻolana o kēia manawa a me nā manaʻo like ʻole. ʻAʻole maopopo ka ʻoihana. ʻAʻole hiki i ka ʻoihana ke hoʻokō i kāna mau manaʻo, a ʻaʻole paha i pololei kāna mau manaʻoʻiʻo. He ʻokoʻa paha nā hopena maoli mai nā mea i wehewehe ʻia a i ʻole i hōʻike ʻia e kēlā mau ʻōlelo i mua ma muli o nā kumu koʻikoʻi like ʻole, akā, ʻaʻole i kaupalena ʻia i: ka pono o ka Hui no ke kumulāʻau hou aʻe a me kona hiki ke hoʻonui i ke kālā inā makemake ʻia;ka FDA a me nā mana like ʻole o nā ʻāina ʻē He lōʻihi ke kaʻina hana hoʻoponopono hoʻoponopono, hoʻopau manawa, pipiʻi a ʻike ʻole ʻia;ʻo ka ʻoihana ka ʻike liʻiliʻi i ka ʻike ʻana i ka lāʻau lapaʻau a me ka hoʻomohala ʻana i ka lāʻau;ʻAʻole hiki i nā mea hoʻoponopono ke ʻae a ʻae paha i ka manaʻo o ka hui, nā manaʻo, ka helu ʻana, nā hopena a i ʻole nā loiloi, a i ʻole ʻO ke koʻikoʻi o ka unuhi ʻana a i ʻole ke kaupaona ʻana i ka ʻikepili ma nā ʻano like ʻole, e pili ana i ka waiwai o kekahi papahana, ka ʻae ʻana a i ʻole ke kālepa ʻana o kekahi. moho huahana a i ʻole ka huahana a me ka hui ma ke ʻano laulā;ʻaʻohe ʻike o ka hui i ke kūʻai aku a kūʻai aku i nā lāʻau lapaʻau a ʻaʻohe ʻike me IGALMI a i ʻole BXCL501 kūʻai aku a me nā hoʻonohonoho kūʻai;ʻAʻole ʻae ʻia ʻo IGALMI a i ʻole nā moho huahana ʻē aʻe o ka Hui i nā kauka a i ʻole ke kaiāulu olakino;ʻAʻole hiki i ka Hui ke loaʻa ka ʻae kūʻai aku no BXCL501 ma ʻEulopa a i ʻole nā mana ʻē aʻe;hiki paha i ka Hui ke koi aku i ka nui o ke kapena no ka hoʻomohala ʻana a me ka hana ʻana i nā hoʻokolohua Clinical e pili ana i kāna mau moho huahana a me ke kākoʻo ʻana i kā lākou hana;pono nā hui e hoʻokō i nā ʻano hoʻoponopono e pili ana;Hiki i nā hoʻoponopono mālama ola ke hoʻopilikia i ka kūleʻa pāʻoihana e hiki mai ana. Kūkākūkā ʻia kēia mau mea nui a me nā mea nui ʻē aʻe ma lalo o ke poʻomanaʻo "Risk Factors" i kāna Hōʻike makahiki ma ka Pepa 10-K no ka makahiki i pau i ka lā 31 Dekemaba 2021, no ka mea e ʻike ʻia kēia mau mea i kēlā me kēia manawa. i loko o kāna mau waihona ʻē aʻe me nā SEC Updates, loaʻa ma ka pūnaewele SEC ma www.sec.gov. ʻO kēia a me nā mea koʻikoʻi ʻē aʻe e hiki ke hoʻokaʻawale i nā hopena maoli mai nā mea i hōʻike ʻia e nā ʻōlelo e nānā ana i mua i kēia hoʻolaha paʻi. -ʻo nā ʻōlelo nānā e hōʻike ana i nā manaʻo manaʻo o ka hoʻokele e like me ka lā o kēia hoʻolaha paʻi. ʻAʻole pono e manaʻo ʻia kēia mau ʻōlelo i mua e hōʻike ana i ka manaʻo o ka hui ma kekahi lā ma hope o ka lā o kēia hoʻolaha paʻi.
1 Hoʻokomo pū ʻia ke kālā i nā palapala kauoha e kūʻai i nā ʻāpana o ka ʻoihana maʻamau o ka hui a me nā palapala hōʻoia e kūʻai aku i nā ʻāpana o ka hui ʻoihana ʻo LLC, e like me ka wehewehe piha ʻana i ka hōʻike o kēia manawa ma ka Form 8-K e waiho ʻia ma ʻApelila 19, 2022.
Ka manawa hoʻouna: Mei-07-2022