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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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