San Diego’s Lumena Files for IPO to Fund Liver Drug Trials

Xconomy San Diego — 

Lumena Pharmaceuticals has filed for a $75 million IPO, just a few weeks after the San Diego biopharmaceutical company raised $45 million in venture funding.

Lumena was founded in 2011 to develop oral drugs for treating a rare group of metabolic disorders that cause bile acid to build up in the liver. Bile acids facilitate the absorption of dietary cholesterol, fat, and fat-soluble vitamins. The company says bile acids are increasingly being recognized as signaling molecules that regulate metabolic processes. They are synthesized in the liver and stored in the gall bladder, where they are released into the gastrointestinal tract to help digest food.

The FDA granted orphan drug status in September to Lumena’s lead drug candidate, LUM001, for treating Alagille Syndrome and several related cholestatic liver diseases in the United States. Health regulators in the European Union gave a similar designation to LUM001 earlier this year.

Genetic disorders often play a central role in cholestatic liver diseases, which impair bile flow from the liver, resulting in fatigue and severe itching that cannot be relieved. There are no approved therapies in the U.S. for many of these disorders, which can eventually result in liver failure. Lumena in-licensed LUM001 from Pfizer, which had shelved the compound after conducting extensive clinical trials as a potential cholesterol-lowering drug.

In its IPO filing, Lumena says preclinical and clinical data suggest that blocking the process of bile acid transport and reducing bile acid reabsorption has the potential to slow the progression of disease, improve liver function, and enhance the quality of life for patients with cholestatic liver diseases and related metabolic disorders. Lumena’s LUM001, and a second drug candidate, LUM002, inhibit a mechanism known as the apical sodium-dependent bile acid transporter.

Net proceeds from the IPO, together with existing cash, should be sufficient to fund the company’s operations for the next two years, according to the filing. That includes funding seven ongoing or planned mid-stage clinical trials of LUM001 and one planned mid-stage clinical trial of LUM002 for the treatment of nonalcoholic steatohepatitis, a metabolic disorder characterized by fat deposits in the liver that can lead to inflammation and significant fibrosis.

After raising $23 million in a Series A round of venture financing in 2013, Lumena raised an additional $45 million in early March in a Series B round led by New Enterprise Associates. Adage Capital Management and RA Capital Management also participated, joining existing investors Pappas Ventures, RiverVest Venture Partners, and Alta Partners.

Lumena’s biggest shareholder is Alta Partners, which currently holds a 34 percent stake in the company. New Enterprise Associates has a 17 percent stake, RiverVest Ventures holds 14.9 percent, Pappas Ventures owns 12.2 percent, and Adage Capital Partners holds 7.9 percent, according to the filing.

The company reported a net loss of $8.6 million in 2012, and $15.1 million last year, according to the filing. It has an accumulated deficit of $24.6 million as of December 31, 2013.