Strug­gling poo-test­ing start­up uBio­me files for bank­rupt­cy, months af­ter FBI kicks off in­ves­ti­ga­tion

George Church Har­vard

Months af­ter the FBI launched a probe in­to its billing prac­tices, be­lea­guered poo-test­ing start­up uBio­me has filed for bank­rupt­cy.

Jes­si­ca Rich­man and Zach Apte launched uBio­me in 2012, af­ter rais­ing $350,000 from a crowd­fund­ing cam­paign to fa­cil­i­tate a mi­cro­bio­me study. The com­pa­ny — which maps the ecosys­tem of mi­crobes in the body to de­vel­op tests eval­u­at­ing gut and vagi­nal health — has since hauled in more than $100 mil­lion in ven­ture cap­i­tal from Y Com­bi­na­tor, An­dreessen Horowitz, and 8VC.

In the be­gin­ning, San Fran­cis­co-based uBio­me made all the right moves.  It wooed a num­ber of lead­ing sci­en­tists from UCSF and Har­vard, in­clud­ing ge­neti­cist George Church, on its sci­en­tif­ic ad­vi­so­ry board, re­cruit­ed for­mer con­tro­ver­sial No­var­tis CEO Joe Jimenez to its board, re­leased a hand­ful of di­rect-to-con­sumer tests de­signed to gauge mi­cro­bial health, and inked a part­ner­ship with L’Oréal to re­search the skin mi­cro­bio­me.

But soon, things start­ed to fall apart. In April, the FBI com­menced an in­ves­ti­ga­tion in­to the com­pa­ny’s billing prac­tices — even­tu­al­ly raid­ing uBio­me’s of­fices — around the time sources told CN­BC that the start­up was hound­ing doc­tors to ap­prove tests with lit­tle over­sight, billing con­sumers mul­ti­ple times with­out their con­sent —and in­sur­ance plans were start­ing to re­ject the claims.

The com­pa­ny got rid of half its staff ear­li­er this sum­mer. In ad­di­tion, in­sid­ers told Busi­ness In­sid­er that the sci­ence back­ing up its tests was flawed from the start — trig­ger­ing an in­ter­nal in­ves­ti­ga­tion. A jour­nal where uBio­me pub­lished its ba­sic re­search is al­so in­ves­ti­gat­ing the com­pa­nies claims, BI re­port­ed. The sale of some of the com­pa­ny’s tests was al­so re­cent­ly sus­pend­ed.

Short­ly af­ter the FBI in­ves­ti­ga­tion be­came pub­lic, uBio­me’s founders de­part­ed to make room for a new man­age­ment team.

In a fil­ing, uBio­me blamed its founders for much of its trou­ble. “The Founders im­ple­ment­ed cer­tain busi­ness strate­gies…that were high­ly prob­lem­at­ic, con­tained sig­nif­i­cant op­er­a­tional (but not sci­en­tif­ic) flaws and, in some in­stances, were of ques­tion­able le­gal­i­ty,” the fil­ing said.

“These is­sues in­clud­ed im­prop­er in­sur­ance provider billing prac­tices, im­prop­er use of a telemed­i­cine physi­cian net­work (known as the Ex­ter­nal Clin­i­cal Care Net­work), over­ly ag­gres­sive and po­ten­tial­ly mis­lead­ing mar­ket­ing tac­tics, ma­nip­u­la­tion of cus­tomer up­grade test­ing, and im­prop­er use of cus­tomer in­duce­ments. More­over, cer­tain in­for­ma­tion pre­sent­ed to po­ten­tial in­vestors dur­ing the three rounds of cap­i­tal raise my have been in­cor­rect and/or mis­lead­ing.”

“(W)hile the Debtor ex­pe­ri­enced a se­ri­ous set­back as a re­sult of the (FBI) In­ves­ti­ga­tion, the In­ves­ti­ga­tion re­sult­ed from the busi­ness prac­tices im­ple­ment­ed by the Founders, not bad sci­ence or bad lab prac­tices. The Debtor has es­tab­lished a new Board and a new Busi­ness Plan, and is poised to move for­ward. This Chap­ter 11 Case will pro­vide the fresh start nec­es­sary to do so.”

Af­ter fil­ing for bank­rupt­cy, uBio­me has se­cured $8 mil­lion in fi­nanc­ing from Sil­i­con Val­ley Bank. The start­up is seek­ing to con­sum­mate a sale of its busi­ness with­in the first 75 days, and in a sep­a­rate fil­ing un­veiled it cur­rent­ly has as­sets worth $50 to $100 mil­lion, an es­ti­mat­ed li­a­bil­i­ties in the range of $10 to $50 mil­lion.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

UP­DAT­ED: In­ter­nal Trump-era emails re­veal a pletho­ra of celebs, com­pa­nies vy­ing for FDA’s at­ten­tion

The FDA on Thursday publicly released a trove of about 500 pages of internal and heavily redacted emails, showing how celebrities like Dr. Oz and Laura Ingraham vied for the FDA’s attention on Covid-related issues that ultimately proved to be a waste of time.

Many of the conversations, obtained via the Freedom of Information Act, involve major Trump-era health officials who, in retrospect, made crucial and often ill-advised decisions on increasing access to the over-hyped hydroxychloroquine.

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