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.


Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.

Plagued by de­lays, As­traZeneca HQ costs soar to £750M as it edges to­ward 2020 com­ple­tion

In the lat­est up­date on As­traZeneca’s de­lay-prone HQ project, the phar­ma gi­ant re­vealed that the cost of con­struc­tion has swelled to £750 mil­lion ($956 mil­lion) — more than dou­ble the orig­i­nal es­ti­mate in 2013.

The move-in date is still in 2020, a spokesper­son con­firmed, af­ter As­traZeneca pushed pro­ject­ed com­ple­tion from 2016 to 2017, and then to the spring of 2019. While the ini­tial plan called for a £330 mil­lion (then $500 mil­lion) in­vest­ment, the cost bal­looned to £500 mil­lion ($650 mil­lion), and more in the most re­cent up­date.

Fresh analy­sis spot­lights car­dio ben­e­fit of J&J's In­vokana in di­a­betes pa­tients with­out his­to­ry of CV dis­ease

In­vokana sales may be mut­ed, but the di­a­betes drug is set to get some love af­ter its mak­er J&J un­veiled da­ta at the Amer­i­can Di­a­betes As­so­ci­a­tion meet­ing on Tues­day sug­gest­ing the med­i­cine can con­fer a car­dio­vas­cu­lar ben­e­fit in pa­tients who do not have pre­ex­ist­ing CV dis­ease.

Back in April, J&J had re­port­ed that in the late-stage CRE­DENCE study, the SGLT2 drug scored a 30% re­duc­tion in the risk of a com­pos­ite of ail­ments: a pro­gres­sion to the dou­bling of serum cre­a­ti­nine, end-stage kid­ney dis­ease and re­nal or car­dio­vas­cu­lar death. In terms of sec­ondary end­points, the drug was al­so found be heart-pro­tec­tive: low­er­ing the risk of CV death and hos­pi­tal­iza­tion for heart fail­ure by 31%, as well as ma­jor ad­verse CV events by 20%. In March, the com­pa­ny sub­mit­ted an ap­pli­ca­tion to ex­pand In­vokana’s la­bel to re­flect its im­pact on chron­ic kid­ney dis­ease.

Sil­i­con Val­ley's most an­tic­i­pat­ed slide deck just dropped. What does it mean for bio­phar­ma's dig­i­tal teams?

These aren’t the typ­i­cal slides you’d see at End­points — no mol­e­cules, clin­i­cal pro­grams, or p-val­ues. In­stead, we’ll talk dig­i­tal and in­ter­net trends, fac­tors that elite glob­al brands — re­gard­less of in­dus­try — must first mea­sure and un­der­stand be­fore de­ploy­ing prod­ucts in­to the world. That’s a con­cept that most of our Big Phar­ma au­di­ence is in tune with. Dig­i­tal aware­ness is key to suc­cess in the dis­cov­ery, de­vel­op­ment, and mar­ket­ing of new bio­phar­ma­ceu­ti­cals, and most of the ma­jors now have a chief dig­i­tal of­fi­cer: No­var­tis, Sanofi, and Pfiz­er, just to name a few.