Crushed by a tri­al fail­ure, Tokai hands the reins — and the stock list­ing — to Ot­ic

Gre­go­ry J. Flesh­er, Ot­ic

Last Au­gust, Tokai be­came the lat­est in a long string of pub­lic biotechs to hit a brick wall run­ning at full speed. The late-stage fail­ure of its can­cer drug galeterone ef­fec­tive­ly shred­ded its stock price and its busi­ness plan, forc­ing the com­pa­ny to rapid­ly ax staffers and start look­ing for strate­gic al­ter­na­tives in the face of an ex­tinc­tion-lev­el event.

To­day, the in­vestors at Ot­ic Phar­ma took over the shell and ex­e­cut­ed a quick short­cut to a Nas­daq list­ing. Tokai, with its mar­ket cap set at about $22 mil­lion, saw its shares $TKAI jump 57%. Its in­vestors will wind up with about 40% of the new com­pa­ny, with Ot­ic in charge.

Ot­ic’s in­vestors, mean­while, are adding $7 mil­lion to the com­pa­ny as it ex­e­cutes the deal.

While the biotech win­dow hasn’t ful­ly closed this year, it has nar­rowed con­sid­er­ably fol­low­ing the 2013-2015 go-go years. That’s made re­verse merg­ers like this more ap­peal­ing to com­pa­nies like Ot­ic, which is ad­vanc­ing its own ear­ly-stage pro­gram to mid-stage stud­ies.

“Our lead pro­gram in oti­tis me­dia, OP-02, has sig­nif­i­cant po­ten­tial,” said Gre­go­ry J. Flesh­er, Chief Ex­ec­u­tive Of­fi­cer of Ot­ic Phar­ma. “OP-02 is an in­ves­ti­ga­tion­al drug prod­uct de­signed to break the cy­cle of re­cur­rent and chron­ic oti­tis me­dia which af­fect mil­lions of peo­ple around the world. We ex­pect to have phase 1 clin­i­cal phar­ma­co­dy­nam­ic da­ta in the first half of 2017 and, with this trans­ac­tion, to have the cap­i­tal need­ed to be able to move di­rect­ly in­to phase 2 de­vel­op­ment to ex­plore the prod­uct’s abil­i­ty to pre­vent oti­tis me­dia in chil­dren.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Enrique Conterno, FibroGen

As it awaits piv­otal re­view of lead drug, Fi­bro­Gen bol­sters its ear­ly pipeline with li­cens­ing deal for galectin pro­gram

FibroGen’s long-awaited review for anemia med roxadustat is just weeks away, and there’s good reason to believe the outcome won’t swing in its favor after a data manipulation scandal and tepid analyst consensus on the drug’s chances. With its future murky, FibroGen is now opening the pocketbook to refresh its pipeline for whatever the next phase may be.

FibroGen will shell out $25 million in cash for a global license to Boston-area biotech HiFiBiO’s galectin-9 platform targeting immuno-oncology and autoimmune disorders, the partners said Thursday.

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Samantha Du, Zai Lab

Chi­nese on­col­o­gy spe­cial­ist Zai Lab bro­kers a deal with Macro­Gen­ics for up to 4 bis­pecifics with a mod­est down pay­ment

Samantha Du’s Zai Lab has earned its reputation as a Chinese oncology partner of choice with an aggressive licensing strategy to tap that growing market. Now, a West Coast bispecifics player with a lead collaboration molecule already identified will add its name to Zai Lab’s growing rolodex.

Zai Lab will shell out $55 million upfront — $25 million in cash and $30 million in equity — for a mix of Asian and global rights to four of San Francisco-based MacroGenics’ bispecific antibodies, with one lead molecule already in development, the partners said Wednesday.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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