Arc­turus takes an­oth­er le­gal stab at for­mer CEO as pub­lic bat­tle turns se­ri­ous for the com­pa­ny

The bit­ter and pub­lic feud be­tween small RNA med­i­cines com­pa­ny Arc­turus Ther­a­peu­tics $ARCT and its for­mer CEO Joe Payne is rag­ing on Fri­day, with a brand new law­suit (yes, an­oth­er one) launched against Payne and a few of his as­so­ciates.

Joseph Payne

In the law­suit, Arc­turus al­leges that Payne and his as­so­ciates Bradley Soren­son, Pe­ter Far­rell, and An­drew Sas­sine (col­lec­tive­ly re­ferred to as “the Payne group”) have failed to file cer­tain pa­per­work with the SEC. Specif­i­cal­ly, the law­suit ac­cus­es the group for mul­ti­ple vi­o­la­tions of fed­er­al dis­clo­sure and re­port­ing rules un­der Sec­tion 13(d) of the Ex­change Act and Reg­u­la­tion 13D.

Arc­turus says it’s seek­ing in­junc­tive re­lief to com­pel the Payne group to com­ply with these reg­u­la­tions, but per­haps more im­por­tant­ly, the law­suit al­so seeks to pre­vent Payne and his as­so­ciates from “con­tin­u­ing to mis­lead the vot­ing share­hold­ers of Arc­turus lead­ing up to the next ex­tra­or­di­nary gen­er­al meet­ing of share­hold­ers.”

In oth­er words, Arc­turus is hop­ing if it airs Payne’s dirty laun­dry, then share­hold­ers won’t side with Payne’s pro­pos­al to re­place the whole Arc­turus board with his own ap­point­ments.

Payne, the for­mer chief ex­ec­u­tive who was fired from Arc­turus for al­leged­ly putting his own self-in­ter­ests be­fore the com­pa­ny’s, has been a bit of a thorn in the com­pa­ny’s side over the past cou­ple of months. Payne took the first pub­lic swing in the bat­tle roy­al, claim­ing that four board mem­bers con­spired on his ouster. But then Arc­turus hit back with its own state­ment, even as it com­plied with Payne’s re­quest to vote on new board mem­bers.

Then late last month, the drawn out fight took a nasty turn when Arc­turus launch­es its first law­suit against Payne, seek­ing dam­ages and in­junc­tive re­lieve and de­tail­ing Payne’s mul­ti­ple al­leged mis­con­ducts. Those in­clud­ed op­er­at­ing a “lu­cra­tive side busi­ness dur­ing busi­ness hours” and at­tempt­ing to trans­fer Arc­turus’ IP for no ap­par­ent rea­son dur­ing his tenure, in ad­di­tion to or­ches­trat­ing a move to block Arc­turus’ rou­tine au­dit­ing ac­tiv­i­ty.

But things are start­ing to get re­al for Arc­turus, it says, as Payne’s ac­tions could have se­ri­ous con­se­quences for the com­pa­ny. That move with the au­di­tors, for ex­am­ple, could po­ten­tial­ly re­sult in Arc­turus get­ting boot­ed from the Nas­daq. In a state­ment, Arc­turus had this to say:

“The Payne Group’s ac­tions are cal­cu­lat­ed non-dis­clo­sures that promise to keep Arc­turus share­hold­ers in the dark at this crit­i­cal time in the Com­pa­ny’s his­to­ry, caus­ing di­rect and on­go­ing harm to the Com­pa­ny and its share­hold­ers as the EGM ap­proach­es. We be­lieve that if Payne and his as­so­ciates are al­lowed to con­tin­ue to evade dis­clo­sure re­quire­ments and op­er­ate in vi­o­la­tion of Reg­u­la­tion 13D, Arc­turus will not be able to have a free and fair di­rec­tor elec­tion.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

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The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Francesco Marincola (Kite)

Gilead­'s Kite re­cruits an Ab­b­Vie/NIH vet­er­an to head up cell ther­a­py R&D. And he's tak­ing aim at AML in a fe­ro­cious­ly com­pet­i­tive field

Four months after Kite R&D exec Peter Emtage jumped ship to sign on with Versant as a CEO-in-waiting, the big Gilead sub has recruited immuno-oncology expert Francesco Marincola to take his place as head of cell therapy research — putting him in a prominent position in a booming field.

Marincola has been making the rounds to a certain extent as cell therapy took hold as one of the hottest fields in drug R&D. He made his rep at the NIH — where he spent 23 years, 15 as head of the Infectious Disease and Immunogenetics Section at the NIH Clinical Center — and then jumped to AbbVie, where he guided I/O discovery strategy. The research exec spent close to 3 years in his last post as CSO at Refuge Biotechnologies.

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Eric Lander, Office of Science and Technology Policy nominee (Matt Slocum/AP Images)

Biden el­e­vates White House sci­ence of­fice to Cab­i­net-lev­el, with ge­neti­cist Er­ic Lan­der put for­ward to lead pol­i­cy

As incoming President-elect Joe Biden fills out his administration, he has plans to elevate a longtime White House office to a Cabinet-level agency — and has tapped a prominent geneticist to lead its efforts.

Biden will nominate Eric Lander to head up the Office of Science and Technology Policy, his transition team announced last Friday, in a move the President-elect said will emphasize the focus of science in his government. In addition to being a mathematician, Lander was a key leader of the team that mapped the human genome in 2003 and founded the Broad Institute at MIT, which is famous for its work with CRISPR-Cas9 technology.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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