Run­ning out of cash and kicked out of its HQ by the land­lord, Pixar­Bio hun­kers down and slash­es staff

A year ago Pixar­Bio re­verse merged its way on­to the pub­lic mar­kets, promis­ing to raise tens of mil­lions in cash as it led the way on de­vel­op­ment of a pain ther­a­py that could re­place mor­phine. The com­pa­ny con­fi­dent­ly pre­dict­ed an ap­proval and mar­ket launch in 2018, boast­ing of tech­nol­o­gy that came out of the lab of MIT pro­fes­sor Bob Langer.

And it’s been down­hill ever since.

In a mid-June SEC fil­ing, the biotech says it was forced to give up its leased prop­er­ty in Mass­a­chu­setts, in­clud­ing its head­quar­ters in Med­ford, laid off more than half of its staff as it bled cash and grap­pled with an SEC fraud in­ves­ti­ga­tion, deny­ing any wrong­do­ing. Its staff has been re­duced from 27 to 10 in the first 6 months of this year.

In the mean­time, its shares $PXRB — an OTC stock — are trad­ing at around 29 cents.

Frank Reynolds

Pixar­Bio, helmed by CEO Frank Reynolds, says it got in­to a scrap with their land­lord on the Med­ford lease af­ter a late pay­ment. So now, in place of that month­ly $23,341 rent pay­ment, they are pay­ing $3,003 for a new, small­er of­fice in Salem, NH.

Then there’s the SEC probe:

Pur­suant to SEC sub­poe­nas re­lat­ed to the in­ves­ti­ga­tion of the Com­pa­ny, sev­er­al peo­ple have giv­en tes­ti­mo­ny and we have pro­duced sub­stan­tial doc­u­ments to the SEC. We have co­op­er­at­ed with the SEC. The Com­pa­ny and all of the di­rec­tors and/or of­fi­cers de­ny all al­le­ga­tions of wrong­do­ing. Al­though there can be no as­sur­ance that such in­ves­ti­ga­tion shall be re­solved suc­cess­ful­ly, the Com­pa­ny is op­ti­mistic that the in­ves­ti­ga­tion shall be re­solved suc­cess­ful­ly.

In the mean­time, Reynolds and his fam­i­ly have been lend­ing mon­ey to the com­pa­ny in ex­change for promis­so­ry notes to­tal­ing more than $250,000. That’s sub­stan­tial­ly more than the com­pa­ny had in the bank when it filed its 8-K.

Our cash on hand on April 30, 2017 was $71,800. Our cur­rent av­er­age month­ly cash burn rate is ap­prox­i­mate­ly $450,000.

Back in Jan­u­ary Reynolds an­nounced that the com­pa­ny had with­drawn its of­fer to buy In­Vi­vo Ther­a­peu­tics — which he once ran — “for rea­sons re­lat­ed to man­age­ment cred­i­bil­i­ty and com­pe­tence, cor­po­rate gov­er­nance and IP con­trol.” It linked to a 4-page let­ter out­lin­ing a list of griev­ances against In­Vi­vo, which had ear­li­er sued him.

UP­DATE 4:13pm — In re­sponse to this ar­ti­cle, Reynolds sent this email to End­points News:

It ap­pears that you were in­flu­enced by false state­ments in an er­ro­neous ar­ti­cle in yes­ter­day’s Boston Busi­ness Jour­nal by Max Sten­dahl.  You have the same er­ro­neous mes­sage that Pixar­Bio left Mass­a­chu­setts and we’re some­how head­ing “down­hill”.  My team in Cam­bridge was shocked to read it.  We re­main in Cam­bridge, MA and on tar­get for FDA ap­proval in 2019.

Pixar­Bio re­mains in Cam­bridge, MA where we have labs, of­fices and a vi­var­i­um.  I have been in Cam­bridge since the end of my for­mal ed­u­ca­tion at MIT and Har­vard in 2005-2006.  We con­tin­ue to raise cash from our very loy­al in­vestors.

I found­ed Pixar­Bio in Salem NH in Au­gust 2013, be­cause I’m dis­abled af­ter be­ing par­a­lyzed in 1992.  I need to work from home so we have our HQ at my home.  As a dis­abled work­er I nev­er miss a day of work but it re­quires a wide range of adap­tive tech­nolo­gies to keep me work­ing 18-20 hour days, 7 days per week.  The best place for me to op­ti­mize my work is in Salem NH so we moved back to where we found­ed the com­pa­ny.

We’re cer­tain­ly not run­ning any­where.  I in­vent and patent my own Neu­ro-tech­nolo­gies, then fund them my­self.

The BBJ re­porter Max Sten­dahl spoke with me and I con­firmed with Max twice that Pixar­Bio re­mains in Cam­bridge, MA yet Max ig­nored the truth, so he clear­ly has an agen­da against Pixar­Bio.  Max wrote that I’ve been ac­cused of Fraud and that is a false state­ment and Max was not wise to write such a bold false state­ment.  As a CEO/CFO/CSO I’m a straight shoot­er in Phar­ma so I may ruf­fle feath­ers out-in­vent­ing all of my com­peti­tors but I al­ways get the job done.

In Ju­ly 2016 Pixar­Bio an­nounced our Rib­bon cut­ting on our of­fices in Fort Lee NJ, so we can be close to our man­u­fac­tur­ing part­ner.  We an­nounced Jan 2, 2017 that we out­sourced man­u­fac­tur­ing to the glob­al man­u­fac­tur­ing leader for drug de­liv­ery sys­tems so we were cut­ting peo­ple and over­head.  Clos­ing of Med­ford should not sur­prise any­one as it was wide­ly re­port­ed by me in the press.  I in­vest­ed over $10,000,000.00 of my own cash in­to Pixar­Bio and al­though not in hu­mans yet, we have over 40 pre-clin­i­cal stud­ies where our pain treat­ment treats pain with every dose.

We have re­searched and de­vel­oped a tru­ly rev­o­lu­tion­ary pain treat­ment called Neu­roRe­lease.  We sim­ply take a pill Car­ba­mazepine that is FDA ap­proved for PAIN, and we re­for­mu­late it for lo­cal de­po in­jec­tion to treat PAIN.  As a 505(B)(2) we have less than one year clin­i­cal stud­ies.

We have sub­mit­ted a sem­i­nal pa­per to a peer re­view jour­nals this week for pub­lish­ing this fall 2017.  Our re­searchers on the pa­per in­clude our sci­en­tif­ic ad­vi­so­ry board mem­bers from Sloan-Ket­ter­ing and NY Pres­by­ter­ian- Cor­nell Weill.

Pixar­Bio’s Neu­roRe­lease re­mains the on­ly non-opi­ate en­gag­ing that FDA that can re­place opi­ates like mor­phine in hos­pi­tals and re­move ad­dic­tion from the clin­ic.  This week our on­ly com­peti­tor Paci­ra Phar­ma­ceu­ti­cals re­port­ed flat sales quar­ter over quar­ter, and they have re­port­ed tox­ic prob­lems with their drug Ex­par­el.

We’ve en­joyed the en­gage­ment with the SEC.  I have an ex­cel­lent SEC com­pli­ance ed­u­ca­tion and SEC com­pli­ance ex­pe­ri­ence so we’ve all learned a lot about fu­ture SEC com­pli­ance to en­sure we’ll avoid fu­ture re­views.  We have nev­er been ac­cused of Fraud as Max stat­ed, so we were shocked to read it but we’ll wrap up the SEC re­view and move for­ward to­ward FDA ap­proval.

In re­gards to In­Vi­vo lit­i­ga­tion, I’m 11-0 against In­Vi­vo Ther­a­peu­tics in court since 2013, they will nev­er es­cape jus­tice.  I in­vent­ed the Neu­roScaf­fold for spinal cord in­jury, it was not in­vent­ed at MIT and I’ve filed over 140 patents cov­er­ing my Neu­ro­log­i­cal treat­ments such as the Neu­roScaf­fold for spinal cord in­jury and Neu­roRe­lease pain treat­ment drugs.  I’ve in­vent­ed in my own Cam­bridge, MA labs since 2005 not at MIT.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Kathy High (file photo)

Gene ther­a­py pi­o­neer Kathy High has left Spark af­ter com­plet­ing $4.3B union with Roche

Kathy High dedicated the past seven years of her life shepherding experimental gene therapies she’s developed at Children’s Hospital of Philadelphia toward the market as president and head of R&D at Spark Therapeutics. Now that the biotech startup is fully absorbed into Roche — with an FDA approval, a $4.3 billion buyout and a promising hemophilia program to boast — she’s ready to move on.

Roche confirmed her departure with Endpoints News and noted “she will take some well-deserved time off and then will begin a new chapter in a sabbatical at a university.”

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Deborah Dunsire

The fourth CGRP mi­graine drug is here. Time for Lund­beck to prove it's worth $2B

They may be late, but Lundbeck is now officially in the game for preventing migraine with CGRP drugs.

The FDA has OK’d eptinezumab, the prize in Lundbeck’s $2 billion acquisition of Alder. Like rival offerings from Amgen/Novartis, Eli Lilly and Teva, the antibody blocks the calcitonin gene-related peptide, which is believed to dilate blood vessels in the brain and cause pain.

It will now be sold as Vyepti. The company has yet to announce a price. Amgen and Novartis had set the wholesale acquisition cost of their pioneering Aimovig at $6,900 for a year’s supply before raising it slightly this year; Lilly and Teva had followed suit with Emgality and Ajovy.

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Tal Zaks (Moderna via YouTube)

For two decades, a new vac­cine tech­nol­o­gy has been slow­ly ap­proach­ing prime time. Now, can it stop a pan­dem­ic?

Two months before the outbreak, Moderna CMO Tal Zaks traveled from Cambridge, MA to Washington DC to meet with Anthony Fauci and the leaders of the National Institutes of Health.

For two years, Moderna had worked closely with NIH researchers to build a new kind of vaccine for MERS, one of the deadliest new viruses to emerge in the 21st century. The program was one test for a new technology designed to be faster, cheaper and more precise than the ways vaccines had been made for over a century. They had gathered evidence the technology could work in principle, and Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases and a longtime advocate for better epidemic preparedness, wanted to see if it, along with a couple of other approaches, could work in a worst-case scenario: A pandemic.

“[We were] trying to find a test case for how to demonstrate if our technology could rapidly prepare,” Zaks told Endpoints News.

Zaks and Fauci, of course, wouldn’t have to wait to develop a new test. By year’s end, an outbreak in China would short circuit the need for one and throw them into 24/7 work on a real-world emergency. They also weren’t the only ones with new technology who saw a chance to help in a crisis.

An ocean away, Lidia Oostvogels was still on vacation and relaxing at her mother’s house in Belgium when her Facebook started changing. It was days after Christmas and on most people’s feeds, the news that China had reported a novel virus to the World Health Organization blurred into the stream of holiday sweaters and fir trees. But on Oostvogels’s feed, full of vaccine researchers and virus experts, speculation boiled: There was a virus in China, something contained to the country, but “exotic,” “weird,” and maybe having to do with animals. Maybe a coronavirus.

Lidia Oostvogels

“I was immediately thinking like, ‘Hey, this is something that if needed, we can play a role,'” Oostvogels told Endpoints.

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Christos Kyratsous (via LinkedIn)

He built a MERS treat­ment in 6 months and then the best Ebo­la drug. Now Chris­tos Kyrat­sous turns his sights on Covid-19

TARRYTOWN, NY — In 2015, as the Ebola epidemic raged through swaths of West Africa, Kristen Pascal’s roommates sat her down on their couch and staged an intervention.

“Are you sure this is what you want to be doing with your life?” she recalls them asking her.

Special report

Pascal, a research associate for Regeneron, had been coming home at 2 am and leaving at 6 am. At one point, she didn’t see her roommate for a week. For months, that was life in Christos Kyratsous’ lab as the pair led a company-wide race to develop the first drug that could effectively treat Ebola before the outbreak ended. For Pascal, that was worth it.

“I’m ok, I don’t have Ebola,” Pascal told them. “I see that death toll rising and I can’t not do something about it.”

Last August, Regeneron learned they had succeeded: In a large trial across West Africa, their drug, REGN-EB3, was vastly more effective than the standard treatments. It was surprise news for the company, coming just 10 months into a trial they thought would take several years and a major victory in the global fight against a deadly virus that killed over 2,000 in 2019 and can carry a mortality rate of up to 90%.

For Kyratsous and Pascal, though, it brought only fleeting reprieve. Just four months after the NIH informed them REGN-EB3 worked, Kyratsous was back in his office reading the New York Times for updates on a new outbreak on another continent, and wondering alongside Pascal and senior management whether it was time to pull the trigger again.

In late January, as the death toll swelled and the first confirmed cases outside China broke double digits, they made a decision. Soon they were back on the phone with the multiple government agencies and their coronavirus partners at the University of Maryland’s Level 3 bio lab. The question was simple: Can Kyratsous and his team use a process honed over two previous outbreaks, and create a treatment before the newest epidemic ends? Or worse, if, as world health experts fear, it doesn’t vanish but becomes a recurrent virus like the flu?

“Christos likes things immediately,” Matt Frieman, Regeneron’s coronavirus collaborator at the University of Maryland, told Endpoints. “That’s what makes us good collaborators: We push each other to develop things faster and faster.”

Kristen Pascal (Regeneron)

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The first time Regeneron tried to respond to a global outbreak, it was something of a systems test, Kyratsous explains from his office at Regeneron’s Tarrytown headquarters. Kyratsous, newly promoted, has crammed it with photos of his family, sketches of viral vectors and a shark he drew for his 3-year-old son. He speaks rapidly – an idiosyncrasy his press person says has only been aggravated this afternoon by the contents of his “Regeneron Infectious Diseases”-minted espresso glass – and he gesticulates with similar fluidity, tumbling through antibodies, MERS, the novel coronavirus, Ebola-infected monkeys.

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Tim Mayleben (file photo)

Es­pe­ri­on's goldilocks cho­les­terol fight­er wins FDA ap­proval — will its 'tra­di­tion­al' pric­ing ap­proach spur adop­tion?

It’s more effective than decades-old statins but not as good as the injectable PCSK9 — the goldilocks treatment for cholesterol-lowering, bempedoic acid, has secured FDA approval.

Its maker, Esperion Therapeutics, is betting that their pricing strategy — a planned list price of between $10 to $11 a day — will help it skirt the pushback the PCSK9 cholesterol fighters, Repatha and Praluent, got from payers for their high sticker prices.

The sky-high expectations for the pair of PCSK9 drugs that were first approved in 2015 quickly simmered — and despite a 60% price cut, coupled with data showing the therapies also significantly cut cardiovascular risk, sales have not really perked up.

Esperion is convinced that by virtue of being a cheaper oral therapy, bempedoic acid will hit that sweet spot in terms of adoption.

“We’re kind of like the old comfortable shoe,” Esperion’s chief commercial officer Mark Glickman remarked in an interview with Endpoints News ahead of the decision date. “It’s an oral product, once-daily and nontitratable — these are things that just resonate so true with patients and physicians and I think we’ve kind of forgotten about that.”

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James Collins, Broad Institute via Youtube

UP­DAT­ED: A space odyssey for new an­tibi­otics: MIT's ma­chine learn­ing ap­proach

Drug development is complex, expensive and comes with lousy odds of success — but in most cases, if you make it across the finish line brandishing a product with an edge (and play your cards right) it can be a lucrative endeavor.

As it stands, the antibiotic market is cursed — it harbors the stink of multiple bankruptcies, a dearth of innovation, and is consequently barely whetting the voracious appetites of big pharma or venture capitalists. Enter artificial intelligence — the biopharma industry’s cure-all for the pesky process of making a therapeutic, including data mining, drug discovery, optimal drug delivery, and addressable patient population.

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Gilead los­es two more patent chal­lenges on HIV pill, set­ting up court­room fight in Delaware

Gilead sustained two more losses in their efforts to rid themselves of an activist-backed patent lawsuit from the US government over a best-selling HIV pill.

Urged on by activists seeking to divert a portion of Gilead’s revenue to clinics and prevention programs, the Department of Health and Human Services made a claim to some of the patents for the best-selling HIV prevention drug, Truvada, also known as PrEP. Gilead responded by arguing in court that HHS’s patents were invalid.

Today, the US Patent and Trademark Office ruled that Gilead was likely to lose the last two of those challenges as well. The USPTO ruled against Gilead on the first two patents earlier this month.

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Jim Scholefield via PR Newswire

Mer­ck los­es its chief dig­i­tal of­fi­cer, spot­light­ing tal­ent hunt for the hottest ti­tle in Big Phar­ma

Over the last few years we’ve seen the chief digital officer title become one of the hottest commodities in Big Pharma as global organizations hunt the best talent to sharpen the cutting edge of their tech platforms.

But Merck just discovered how hard it may be to keep them focused on pharma.

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