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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus -- chop­ping di­a­betes, car­dio and slash­ing costs in com­pa­ny-wide re­org

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy reveal tomorrow with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.