Skin re­gen­er­a­tion com­pa­ny Po­lar­i­tyTE re­veals SEC in­ves­ti­ga­tion, prob­ing in­to its lead prod­uct, for­mer CFO and cur­rent in­vestors

Days af­ter pub­lish­ing in a med­ical jour­nal a pos­i­tive case study show­cas­ing its tech­nol­o­gy that em­ploys a pa­tient’s own healthy tis­sue to re­gen­er­ate hu­man skin for the treat­ment of burns and wounds, Po­lar­i­tyTE has come un­der fire af­ter it di­vulged it had been sub­poe­naed by the SEC ear­li­er this month.

Po­lar­i­tyTE ex­e­cut­ed a re­verse merg­er with video game pub­lish­er Ma­jesco known for the cult clas­sic Psy­cho­nauts, to get on­to the mar­ket in 2017. The biotech was found­ed by Den­ver Lough — a sur­geon who spe­cial­izes in re­gen­er­a­tive med­i­cine and re­con­struc­tive surgery, who took over as CEO from out­go­ing chief Bar­ry Honig post-merg­er.

Po­lar­i­tyTE CEO Den­ver Lough and oth­er ex­ec­u­tives gath­er to ring the clos­ing bell on Au­gust 14, 2017 Nas­daq

Click on the im­age to see the full-sized ver­sion


Po­lar­i­tyTE — which re­port­ed its fi­nan­cial re­sults on Mon­day — said the com­pa­ny was asked by the SEC on March 1 for a pletho­ra of doc­u­ments re­lat­ed to: the Ma­jesco-Po­lar­i­tyTE merg­er; the com­pa­ny’s cur­rent re­gen­er­a­tive med­i­cine busi­ness; per­for­mance of and com­mu­ni­ca­tions with reg­u­la­tors re­gard­ing its ex­per­i­men­tal lead prod­uct SkinTE; and the pro­mo­tion of the com­pa­ny or its se­cu­ri­ties, in a sep­a­rate fil­ing.

The reg­u­la­tor al­so re­quest­ed doc­u­ments sig­ni­fy­ing com­mu­ni­ca­tions and agree­ments be­tween the com­pa­ny and its for­mer CFO John Stet­son, and cur­rent in­vestors Bar­ry Honig and Michael Brauser. Last Sep­tem­ber, the trio were deemed ‘mi­cro­cap fraud­sters’ by the SEC, who charged them along with sev­en oth­ers for their role in “long-run­ning fraud­u­lent schemes that gen­er­at­ed over $27 mil­lion from un­law­ful stock sales and caused sig­nif­i­cant harm to re­tail in­vestors who were left hold­ing vir­tu­al­ly worth­less stock.”

Po­lar­i­tyTE fired Stet­son in re­sponse to the SEC charge, but Honig and Brauser re­main stake­hold­ers of the com­pa­ny. The two con­trol about 7% of the com­pa­ny’s shares each, ac­cord­ing to fil­ings.

In the Po­lar­i­tyTE fil­ing de­tail­ing the SEC probe, the com­pa­ny be­moaned it had been the tar­get of short sell­er at­tacks “in­clud­ing, but not lim­it­ed to, Cit­ron Re­search, led by An­drew Left, Sharesleuth and Cap­i­tal Fo­rum, as well as anony­mous per­sons and en­ti­ties who post and/or pub­lish what we be­lieve to be co­or­di­nat­ed, de­lib­er­ate­ly and pur­pose­ful­ly false ma­te­ri­als on or with­in in­ter­net-based plat­forms.”

The com­pa­ny em­pha­sized that the “short and dis­tort were pur­pose­ful­ly ma­nip­u­la­tive” to the trad­ing ac­tiv­i­ties of Po­lar­i­tyTE’s stock. How­ev­er, last Oc­to­ber the Utah firm re­ceived a doc­u­ment re­quest from the SEC re­lat­ed to the short sell­er re­ports, which it says it has co­op­er­at­ed with.

Mean­while, this year’s for­mal SEC re­quest was ob­tained in writ­ing by Po­lar­i­tyTE on March 4. The probe is in­ves­ti­gat­ing a num­ber of pos­si­ble vi­o­la­tions of fed­er­al se­cu­ri­ties laws, in­clud­ing the com­pa­ny’s han­dling of pub­lic dis­clo­sures, ben­e­fi­cial own­er­ship re­port­ing and an­ti-price ma­nip­u­la­tion.

Al­though Po­lar­i­tyTE has pre­vi­ous­ly held con­fer­ence calls to dis­cuss its fi­nan­cial re­sults — it did not do so on Mon­day.

In the fil­ing, the com­pa­ny said it in­tend­ed to co­op­er­ate with the SEC re­gard­ing their March 2019 sub­poe­na and the on­go­ing in­ves­ti­ga­tion.

The Salt-Lake city com­pa­ny’s shares $PTE slipped about 2% in Tues­day morn­ing trad­ing, af­ter tum­bling 15% on Mon­day fol­low­ing the an­nounce­ment.

 

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.