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.


BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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