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.

Albert Bourla appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

UP­DAT­ED: Pfiz­er CEO Al­bert Bourla is back in the M&A game, but why is he pay­ing $11.4B for Ar­ray?

Pfiz­er $PFE has cut short its time on the side­lines of bio­phar­ma M&A.

Mon­day morn­ing the phar­ma gi­ant un­veiled an $11.4 bil­lion deal to ac­quire Ar­ray Bio­Phar­ma, beef­ing up its on­col­o­gy work and adding a new re­search hub in Boul­der, Col­orado to its glob­al op­er­a­tions.

At $48 a share, Ar­ray $AR­RY in­vestors will be get­ting a 62% pre­mi­um off the Fri­day close of $29.59.

Pfiz­er, which has strug­gled to gain all the up­side promised in past buy­outs like Medi­va­tion, high­light­ed the ac­qui­si­tion of 2 ap­proved drugs in the deal — Braftovi (en­co­rafenib) and Mek­tovi (binime­tinib).

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Gene ther­a­py R&D deals turn red hot as Big Phar­ma steps up to play

This September will mark the 20th anniversary of the death of Jesse Gelsinger, a young man suffering from X-linked genetic disease of the liver. He was killed in a gene therapy study conducted by Penn’s James Wilson, and the entire field endured a lengthy deep freeze as the field grappled with the safety issues inherent in the work.

Some thought gene therapy R&D would never survive. But it did. And this year marked a landmark approval for Zolgensma, a new gene therapy for spinal muscular atrophy Novartis priced at $2.1 million.

“Gene therapy is the hottest item on the block now. But there was a time when we first got into this trial, where there wasn’t a person in the world who believed that gene therapy would work. We have to remember that,” noted gene therapy investigator Jerry Mendell told SMA News Today.

We’re still right on the pioneering frontier when it comes to getting approvals for gene therapies and launching marketing campaigns with the European green light for bluebird's leading program last Friday underscoring the nascent nature of the field. But gene therapy R&D is booming, and has been for several years now.

The rapid growth of gene therapy clinical development is well known, but we decided to put some numbers on it, to quantify what’s going on. DealForma chief Chris Dokomajilar took a lot over the past 10 years, as the number of deals, R&D partnerships and buyouts steadily gained steam, spiking last year and on track to maintain the surge in 2019.

The upfronts and totals for the dollars on deals so far in 2019 is already close to the 2018 mark, underscoring a new phase of negotiations as the major players step up to gain a piece of the late-stage and commercial action.

Once again, we’re looking at an “overnight” biotech success story, decades in the making.

At some point, that may start to brake the numbers we’re seeing. But for now, as rivals line up to compete for frontline prominence across a range of diseases, the arrows are all pointed north.

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A uni­corn stalks Wall Street in search of IPO cash; CASI Phar­ma in-li­cens­es CD19 ther­a­py from Chi­na’s Ju­ven­tas

→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

UP­DAT­ED: Sanofi Gen­zyme deserts gene ther­a­py de­vel­op­er Voy­ager Ther­a­peu­tics

While gene ther­a­py com­pa­nies re­joice as the sec­tor gains trac­tion with ap­provals and a flur­ry of M&A ac­tiv­i­ty, one play­er is feel­ing the heat.

Back in 2015, Voy­ager Ther­a­peu­tics joined forces with Sanofi Gen­zyme in a deal worth up to $845 mil­lion ($100 mil­lion up­front + a po­ten­tial $745 mil­lion in mile­stones) to co-de­vel­op gene ther­a­pies for se­vere cen­tral ner­vous sys­tem dis­or­ders. But two years lat­er, the French drug­mak­er re­treat­ed, elect­ing to not pick up the op­tion to work on Voy­ager’s Parkin­son’s dis­ease pro­gram. (Last year, the FDA dis­ap­point­ed Voy­ager, telling the com­pa­ny that it was not open to an ac­cel­er­at­ed fil­ing on the Parkin­son’s drug on the ba­sis of Phase II da­ta — in­stead of re­quir­ing an ad­di­tion­al piv­otal study.)

In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

John Oyler, Founder & CEO of BeiGene, at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube

UP­DAT­ED: As Bris­tol-My­ers/Cel­gene tie up loose ends, BeiGene pock­ets $150M from PD-1 breakup

As soon as Bristol-Myers Squibb announced its $74 billion buyout for Celgene, BeiGene emerged as a prominent example of a player whose pact with the big biotech could sour, as its PD-1 candidate seems to overlap with Opdivo. After six months of suspense, the partners say they are finally bringing the 2-year-old deal to an amicable end.

BeiGene $BGNE gets $150 million for the termination in addition to full global rights to tislelizumab. In 2017 Celgene had paid $263 million in upfront license fees to develop the PD-1 inhibitor for solid cancers in the US, Europe, Japan and the rest of the world outside Asia. It also threw in a $150 million equity investment in exchange for BeiGene handling its commercial operations — think Abraxane, Revlimid and Vidaza — in China.

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Exterior of the 1 million square foot Discovery Labs in Upper Merion, PA (PR Newswire)

Philadel­phia cham­pi­ons life sci­ences 'co-work­ing,' re­viv­ing for­mer GSK cam­pus in $500M makeover

In a boost to Philadel­phia’s thriv­ing life sci­ences scene, a for­mer Glax­o­SmithK­line cam­pus and a near­by site has been turned in­to what its de­vel­op­er calls “the largest cowork­ing ecosys­tem” for health­care com­pa­nies in the coun­try.

The Dis­cov­ery Labs, a com­pa­ny spawned by MLP Ven­tures, has se­lect­ed two lo­ca­tions in the King of Prus­sia area as the $500 mil­lion test case for its strat­e­gy of ac­quir­ing and con­vert­ing old phar­ma­ceu­ti­cal R&D fa­cil­i­ties world­wide. The sites add up to 1.64 mil­lion square feet.

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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