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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.