George Scan­gos went back to Wall Street, and came back 700 mil­lion pen­nies short.

Scan­gos’ vaunt­ed start­up Vir Biotech­nol­o­gy raised $143 mil­lion in an IPO they hoped would earn $150 mil­lion. Shares were priced at $20, the low-end of the $20-$22 tar­get.

Launched with back­ing from ARCH Ven­ture’s Robert Nelsen, Masayoshi Son’s Soft­Bank Vi­sion Fund, and the Bill & Melin­da Gates Foun­da­tion, the in­fec­tious dis­ease start­up was one of a new wave of well-re­sourced biotechs that emerged with deep enough cof­fers to pur­sue a full R&D line rather than slow­ly build their case by pick­ing off a sin­gle lead pro­gram.

By the time they were a year old, they had bagged $500 mil­lion in fi­nanc­ing and four aca­d­e­m­ic part­ner­ships,  agreed to two sep­a­rate deals worth more than $1 bil­lion apiece in po­ten­tial mile­stones, and land­ed a promi­nent ex-Bio­gen chief in Scan­gos as CEO.  They had lofty goals to match, aim­ing at such mar­quee and elu­sive dis­eases as HIV and hep B and tout­ing a feel-good “glob­al” busi­ness mod­el by which they would sell their drugs in coun­tries that could pay and let the Gates Foun­da­tion dis­trib­ute them in coun­tries that couldn’t.

The IPO promised in­vestors a peek in­to the de­tails and progress on those deals, while giv­ing Vir cash to fu­el their clin­i­cal tri­als.

Ev­i­dent­ly, the in­vestors were slight­ly un­der­whelmed.

The S-1 shows Vir had burned through $256 mil­lion and had $356.5 mil­lion on hand as of June. Pro­ceeds from the IPO are in­tend­ed to fund ear­ly tri­als for hep B can­di­dates VIR-2218 and VIR-3434, along with the flu vac­cine VIR-2482.  Fil­ings al­so showed their R&D deal with Al­ny­lam — ini­tial­ly an­nounced un­der its $1 bil­lion-plus max­i­mum pay­out — was worth on­ly $10 mil­lion up­front.

Be­fore the of­fer­ing, Nelsen owned the biggest chunk of the biotech at 27%, fol­lowed by the Soft­Bank Vi­sion Fund at 21%. Vir’s haul adds an­oth­er IPO dis­ap­point­ment for Soft­Bank, al­though it’s a gen­tle one com­pared to the CEO-top­pling We­Work quake. Vir is one of eight biotechs Soft­Bank is in­vest­ed in, in­clud­ing Vivek Ra­maswamy’s Roivant.

Scan­gos came to the com­pa­ny with a high-pro­file but less-than-flaw­less record. Al­though he helped make Tec­fidera a mul­ti­ple scle­ro­sis block­buster at Bio­gen, he left the com­pa­ny in 2016 with a thin pipeline.

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.