Two weeks af­ter New Haven, CT biotech BioX­cel Ther­a­peu­tics won FDA ap­proval for the psy­chi­atric drug Igal­mi, the biotech is mak­ing a ma­jor new move: piv­ot­ing its fo­cus to com­mer­cial­iza­tion and spin­ning out much of the rest of its pipeline in­to a new com­pa­ny.

The biotech an­nounced ear­ly Tues­day that they have en­tered in­to strate­gic fi­nanc­ing agree­ments with funds man­aged by two firms: Oak­tree Cap­i­tal Man­age­ment and Qatar’s sov­er­eign wealth fund, Qatar In­vest­ment Au­thor­i­ty. Com­bined, the two funds will net BioX­cel up to $260 mil­lion.

Ac­cord­ing to BioX­cel, the cash will help fund the com­mer­cial launch of Igal­mi, BioX­cel’s new­ly FDA-ap­proved schiz­o­phre­nia and bipo­lar drug, in the US — and push clin­i­cal pipeline de­vel­op­ment for­ward. The biotech al­so said that the funds will push the com­pa­ny’s cash run­way in­to 2025.

CEO Vi­mal Mehta told End­points News that BioX­cel had $233 mil­lion at the end of 2021, which was enough run­way to last the com­pa­ny well in­to 2023.

The long-term strate­gic fi­nanc­ing process was led by Oak­tree and is com­prised of:

• A cred­it agree­ment, al­low­ing for up to $135 mil­lion in a de­layed draw term loan,
• A $120 mil­lion rev­enue-based fi­nanc­ing agree­ment — with up to $120 mil­lion in an un­spec­i­fied, capped rev­enue-based fi­nanc­ing on net sales of IGAL­MI and any oth­er fu­ture BX­CL501 prod­ucts, and
• A $5 mil­lion eq­ui­ty in­vest­ment in BioX­cel com­mon stock.

Un­der the agree­ment, BioX­cel would re­ceive $100 mil­lion fol­low­ing FDA ap­proval “in re­spect of the use of the Com­pa­ny’s BX­CL501 prod­uct for the acute treat­ment of ag­i­ta­tion as­so­ci­at­ed with schiz­o­phre­nia or bipo­lar I or II dis­or­der in adults.” That con­di­tion was cleared two weeks ago with the FDA’s ap­proval of their now-sole ap­proved drug Igal­mi.

In the mean­time, BioX­CEl is form­ing a new sub­sidiary: OnkosX­cel to go af­ter can­cer. Ac­cord­ing to a state­ment and with the fund­ing, OnkosX­cel plans to progress the de­vel­op­ment of BX­CL701, an in­ves­ti­ga­tion­al, oral­ly ad­min­is­tered in­nate im­mune ac­ti­va­tor, de­signed to ini­ti­ate in­flam­ma­tion in a mi­croen­vi­ron­ment around tu­mors.

Mehta said that since BioX­cel now has an ap­proved prod­uct, the com­pa­ny is piv­ot­ing to a com­mer­cial-stage com­pa­ny, and said that there was a need to cre­ate a ded­i­cat­ed re­source for BX­CL701.

“It brings that laser sharp fo­cus to con­tin­ue to ex­pand 701, to take it all the way to prov­abil­i­ty as well as ex­pand in oth­er ar­eas,” Mehta added.

The CEO con­firmed to End­points that for right now, BioX­cel’s lead­er­ship team will be lead­ing OnkosX­cel un­til a new man­age­ment team is in place, which BioX­cel will an­nounce in the sec­ond half of 2022.

BioX­cel CMO Vince O’Neill told End­points that the drug can­di­date that OnkosX­cel is look­ing at first is a DPP8/9 in­hibitor. It is cur­rent­ly be­ing test­ed in a Phase II tri­al in com­bo with Keytru­da in metasta­t­ic, cas­tra­tion-re­sis­tant prostate can­cer.

And while BioX­cel has not made any an­nounce­ments or state­ments as to which in­di­ca­tions the com­pa­ny will pur­sue, O’Neill did note that the com­pa­ny has “a num­ber of or­phan drug des­ig­na­tions.” These in­clude pan­cre­at­ic can­cer, melanoma and soft tis­sue sar­co­ma.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.