Genmab, Mirum Pharma & Fulcrum Raise $653M in Wall Street Debuts

Xconomy National — 

Initial public offerings took a brief summer break the week of Independence Day, but healthcare IPO activity resumed this week as three more companies joined the US public markets. Here’s a recap of the biotech companies that priced IPOs Wednesday evening.

—Genmab is different from the other life science companies that joined the public markets this week. The Denmark-based biopharmaceutical company is a large, international organization whose commercialized products contributed to its $455 million-plus in 2018 revenue. It’s also already familiar with the public markets: Genmab shares trade on the Nasdaq Copenhagen, and they’ve been available over the counter in the US. By listing new shares on the Nasdaq Global Select Market, the company can make its securities accessible to more US investors.

Genmab’s US stock offering raised $505.9 million. The company sold approximately 2.8 million American depository shares priced at $17.75 apiece. The shares are expected to start trading on the Nasdaq Global Select Market on Thursday under the stock symbol “GMAB.” In conjunction with the expected listing of new shares, Genmab has asked Nasdaq Copenhagen to change the company’s stock symbol from “GEN” to “GMAB.”

According to Genmab’s filing, most of the cash from the stock offering will go toward tisotumab vedotin, a cancer drug in mid-stage clinical development in collaboration with Seattle Genetics (NASDAQ: SGEN). The partnership calls for Genmab and SeaGen to split equally the drug’s development costs, and if approved, the profits from sales. The drug is an antibody drug conjugate, a type of drug that links antibodies to toxins that make them more potent cancer killers. Tisotumab vedotin targets a protein involved in tumor signaling and the growth of blood vessels that feed tumors. Genmab and SeaGen are testing the drug as a treatment for cervical cancer and other solid tumors.

In its prospectus, Genmab says it will use $100 million of IPO cash to continue development of tisotumab vedotin in recurrent or advanced cervical cancer, and also to develop the drug as a treatment for other solid tumors. Another $275 million is earmarked for drug discovery, and to finance development of earlier-stage and preclinical programs.

—Mirum Pharmaceuticals raised $75 million to continue clinical development of its drugs for rare liver diseases. The Foster City, CA, company priced its offering of 5 million shares at $15 each, which was the midpoint of its targeted $14 to $16 price range. Mirum’s shares are set to begin trading on the Nasdaq on Thursday under the stock symbol “MIRM.”

Mirum is developing treatments for cholestatic liver disorders, which are diseases that lead to a reduction or stoppage of the flow of bile produced by the organ. Consequently, bile acids can build up to toxic levels, leading to liver damage, failure of the organ, and the need for a liver transplant. Cholestatic liver disease can also cause severe itching called pruritus.

Lead Mirum drug maralixibat is being developed to treat children with a type of cholestatic liver disorder called progressive familial intrahepatic cholestasis (PFIC). The company says in its IPO prospectus that its focus is on a form of the disease that accounts for approximately 60 percent of PFIC patients, caused by a mutation to the gene that encodes the protein that moves bile salts out of the liver. In the second quarter of this year, Mirum began enrolling a Phase 3 study testing the drug in PFIC patients. The Mirum drug was developed to block apical sodium-dependent bile transporter (ASBT), a protein present in the small intestine that plays a role in the intestinal uptake of bile acids. Blocking this protein is meant to lead to more bile acids being eliminated from the body in the feces, in turn leading to lower levels of bile acids in the body. “This leads to improvements in liver function, pruritus and other symptoms of cholestatic liver disease,” the company says in its filing.

Mirum launched late last year backed by $120 million in funding. It licensed marlixibat from Shire, which took an equity stake in the company. Besides financing late-stage testing of its lead drug in PFIC, Mirum says the IPO proceeds will also support a Phase 3 study testing the compound as a treatment for Alagille syndrome (ALGS), an inherited disorder that causes narrow, malformed bile ducts that are fewer in number, leading to accumulation of bile acids in the liver. The ALGS study is expected to start in the first half of next year. A second Mirum drug candidate, volixibat, is being developed to treat cholestatic diseases in adults. The company says it expects to start mid-stage studies testing the drug in two of them, primary sclerosing cholangitis and intrahepatic cholestasis of pregnancy, next year.

—Fulcrum Therapeutics raised $72 million from its IPO to finance clinical research of its experimental treatments for rare genetic diseases. The Cambridge, MA-based company priced its offering of 4.5 million shares at $16 each, which was the low end of its targeted $16 to $18 price range. Those shares are expected to begin trading on the Nasdaq Thursday under the stock symbol “FULC.”

Fulcrum is developing drugs to control molecular switches that turn genes on or off. The company’s first disease target is facioscapulohumeral muscular dystrophy (FSHD), a disorder that leads to the progressive weakening and loss of skeletal muscle. An estimated 40,000 Americans have FSHD, according to the nonprofit FSH Society; worldwide the estimates reach 870,000. Treatment manages complications of the disorder but does not address the underlying cause.

FSHD is caused by the abnormal expression of the DUX4 gene, which leads to the production of DUX4 protein in cells and tissues where it is not typically produced, according to the National Organization for Rare Disorders. Fulcrum’s lead compound, losmapimod, is a small molecule drug licensed from GlaxoSmithKline (NYSE: GSK) intended to reduce the expression of the DUX4 gene. Fulcrum’s pipeline has a second drug candidate, FTX-HbF, which is in preclinical development to treat two blood disorders: sickle cell disease and beta thalassemia.

Fulcrum has raised approximately $135 million in private funding, most recently an $80 million Series B round last September. Most of the IPO cash—about $45 million—is earmarked for clinical trials testing losmapimod in FSHD patients. A Phase 2b study is expected to start in the middle of this year. Fulcrum plans to spend approximately $15 million of the IPO cash on development of FTX-HbF. The company says it plans to file paperwork to start clinical trials for that drug in the middle of next year.

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