Less than a month af­ter land­ing a Big Phar­ma part­ner on one of its lead on­col­o­gy pro­grams, Tem­pest Ther­a­peu­tics is back­flip­ping on­to Nas­daq through a re­verse merg­er with Mil­len­do Ther­a­peu­tics.

Back in Jan­u­ary, Mil­len­do shut down the sole re­main­ing ear­ly-stage study for its NK3R an­tag­o­nist MLE-301 — just nine months af­ter pulling the plug on a piv­otal study for its lead drug liv­o­le­tide. The biotech planned some deep cuts for the re­main­ing staff, while look­ing for a sale or merg­er.

In sup­port of the merg­er, Tem­pest se­cured com­mit­ments from a slate of in­vestors for a $30 mil­lion PIPE fi­nanc­ing, in­clud­ing Ver­sant Ven­tures, Rock Springs Cap­i­tal, F-Prime Cap­i­tal, Monashee In­vest­ment Man­age­ment, Quan Cap­i­tal, Lyfe Cap­i­tal, Maven In­vest­ment Part­ners US, Lil­ly Asia Ven­tures and Eight Roads Ven­tures, the com­pa­ny said on Mon­day. Over­all, the deal should ex­tend the com­pa­ny’s cash run­way through ear­ly 2023, ac­cord­ing to a state­ment.

Tom Duben­sky

Ear­li­er this month, the com­pa­ny inked a deal with Roche to study its TPST-1120 in com­bi­na­tion with Tecen­triq and Avastin in pre­vi­ous­ly un­treat­ed pa­tients with ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma (HCC). The com­pa­ny al­so has TPST-1495, which is in a Phase Ia/Ib dose and sched­ule op­ti­miza­tion study in pa­tients with ad­vanced sol­id tu­mors, specif­i­cal­ly known prostaglandin-dri­ven tu­mors like col­orec­tal can­cer, lung ade­no­car­ci­no­ma and urothe­lial can­cer.

“The tran­si­tion of Tem­pest to a pub­lic com­pa­ny en­hances our abil­i­ty to fund these po­ten­tial­ly im­por­tant prod­uct can­di­dates, as well as con­sid­er ad­di­tion­al pro­grams with ex­cit­ing new tar­gets,” CEO Tom Duben­sky said in a state­ment.

The merg­er is ex­pect­ed to close in the first half of this year, with Mil­len­do stock­hold­ers ex­pect­ed to own ap­prox­i­mate­ly 18.5% of the com­bined com­pa­ny and pre-merg­er Tem­pest stock­hold­ers to hold 81.5%.

Bio­haven hits $100M mile­stone as it gears up for a late-stage study in mi­graine pa­tients

Bio­haven has of­fi­cial­ly launched a Phase II/III tri­al for its oral mi­graine drug, trig­ger­ing a $100 mil­lion pay­off from Roy­al­ty Phar­ma.

Back in Au­gust, Bio­haven added near­ly $1 bil­lion to its bal­ance sheet through a pair of cre­ative agree­ments with Roy­al­ty Phar­ma and the in­vest­ment firm Sixth Street to bol­ster the com­mer­cial launch of its new mi­graine drug, Nurtec. As part of an agree­ment with Roy­al­ty, Bio­haven was promised up to $250 mil­lion to ad­vance its za­veg­epant in mi­graine and oth­er CGRP-me­di­at­ed dis­eases. Bio­haven had al­ready pock­et­ed $150 mil­lion, and will now re­ceive the last $100 mil­lion as it en­rolls the first pa­tient in the Phase II/III study. In to­tal, Bio­haven is look­ing for 2,900 mi­graine pa­tients to test the ef­fi­ca­cy and safe­ty of 100 mg and 200 mg dos­es of oral za­veg­epant.

“Our suc­cess­ful, mul­ti-year part­ner­ship with Bio­haven to sup­port both the reg­u­la­to­ry ap­proval and com­mer­cial­iza­tion of Nurtec as well as pipeline de­vel­op­ment is an ex­cel­lent ex­am­ple of how Roy­al­ty Phar­ma can be a col­lab­o­ra­tive part­ner to in­no­v­a­tive bio­phar­ma com­pa­nies,” Roy­al­ty CSO and co-head of re­search and in­vest­ments Jim Red­doch said in a state­ment.

An in­tranasal for­mu­la­tion of za­veg­epant, for­mer­ly known as vazegepant, achieved su­pe­ri­or ef­fi­ca­cy to place­bo in a Phase II/III study, the com­pa­ny said.

Sim­cere promis­es near­ly $300M for the rights to a for­mer Genen­tech can­di­date

There’s a new glioblas­toma can­di­date in Greater Chi­na.

Sim­cere Phar­ma­ceu­ti­cal Group is putting down $11 mil­lion up­front and up to $281 in mile­stones for the de­vel­op­ment and com­mer­cial­iza­tion rights to Kazia Ther­a­peu­tics’ pax­al­is­ib — a PI3K in­hibitor li­censed from Genen­tech back in 2016. The can­di­date en­tered a piv­otal study ear­li­er this year, and is in sev­en ad­di­tion­al stud­ies for oth­er brain can­cers.

“The need for new ther­a­pies in brain can­cer is sig­nif­i­cant in Chi­na, and we share Kazia’s com­mit­ment to bring­ing for­ward new treat­ment op­tions for pa­tients,” Sim­cere se­nior VP Ren­hong Tang said in a state­ment.

Pax­al­is­ib is dis­tin­guished by its abil­i­ty to cross the blood-brain bar­ri­er, which pre­vents many drugs from ful­ly af­fect­ing brain tis­sue, the com­pa­ny said.

Sim­cere’s up­front pay­ment in­cludes $7 mil­lion in cash and a $4 mil­lion eq­ui­ty in­vest­ment. In ad­di­tion to the $281 mil­lion in mile­stones for glioblas­toma, Kazia can snag more for oth­er in­di­ca­tions, ac­cord­ing to the deal. And Sim­cere will dole out com­mer­cial roy­al­ties in the “mid-teens.” Sim­cere can de­vel­op and mar­ket the drug in Main­land Chi­na, Hong Kong, Macau, and Tai­wan, while Kazia re­tains the rights every­where else.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Clovis Oncology needs a serious leg up after posting a $71.3 million net loss in Q2.

According to the company’s Q2 report, based on its current cash, cash equivalents and liquidity the company will need to raise additional capital in the near term to continue going on beyond February of next year.

A proposed reverse stock split of Clovis’ common stock, which would have freed up more capital, was not approved at its annual meeting of stockholders. The company said in the report it is looking at other sources of funding such as strategic partnerships or licensing arrangements for one or more of its products or candidates.