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Biotech IPOs For The Week Ahead

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The IPO activity in the U.S. pharma/biotech sector has had a strong showing so far this year, with 41 listings in the first half of the year, and 25 listings in the second quarter, which is almost similar to the last year's q2 biotech IPO of 24 listings.

There has not been a single biotech IPO for the month of July so far. As another week comes to a close, let's take a look at the biotech companies that are going public in the week ahead.

1. Mirum Pharmaceuticals Inc.

Foster City, California-based Mirum Pharmaceuticals is a biopharma company developing novel therapies for debilitating liver diseases.

Founded in 2018, the company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "MIRM" on July 18, 2019.

Mirum Pharma has offered to sell 5.0 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 750 thousand additional shares.

The initial public offering price is expected to be between $14.00 and $16.00 per share.

Underwriters of the IPO:

Citigroup Global Markets Inc.,Evercore Group L.L.C.,Guggenheim Securities, LLC, Raymond James & Associates, Inc., Roth Capital Partners, LLC

Pipeline and Near-term Catalysts:

The company's lead drug candidate is Maralixibat, a novel, oral, minimally-absorbed agent, which is currently in development for the treatment of pediatric patients with progressive familial intrahepatic cholestasis [PFIC] and alagille syndrome [ALGS].

A phase III trial of Maralixibat in children with Progressive Familial Intrahepatic Cholestasis, dubbed MARCH-PFIC, is underway, with top-line data readout from the trial expected in late-2020.

A phase III trial of Maralixibat in alagille syndrome is expected to be initiated in the first half of 2020.

Mirum's second drug candidate is Volixibat, indicated for the treatment of adult patients with cholestatic liver diseases. The phase II trials of this compound are expected to start in 2020 and clinical data is expected in 2022.


2.Fulcrum Therapeutics

Cambridge, Massachusetts-based Fulcrum Therapeutics is a clinical-stage biopharmaceutical company developing treatments for genetically-defined diseases with high unmet medical need and an initial focus on rare diseases.

Fulcrum Therapeutics is scheduled to list its common stock on The Nasdaq Global Market under the symbol "FULC" on July 18, 2019. About 4.5 million shares are expected to be sold in the offering, with the initial public offering price set at $16.00 to 18.00 per share.

The company has granted the underwriters an option for 30 days to purchase up to 675 thousand additional shares.

Underwriters of the IPO:

Morgan Stanley & Co. LLC,BofA Securities, Inc. and SVB Leerink LLC

Pipeline:

Fulcrum's lead drug candidate is Losmapimod for facioscapulohumeral muscular dystrophy.

Also in the pipeline is FTX-HbF, a small molecule designed to upregulate fetal hemoglobin in patients with sickle cell disease (SCD), and beta-thalassemia (BT).

Near-term Catalysts:

- phase IIb clinical trial of Losmapimod is expected to be initiated at multiple sites in the United States and Europe.

- Filing of an Investigational New Drug application with the US FDA in mid-2020 for FTX-HbF for the treatment of sickle cell disease (SCD), and beta-thalassemia.

The company plans to utilize its product engine to complete four new drug target identification screens in 2019 in Duchenne muscular dystrophy, Friedreich ataxia, myotonic dystrophy 1 and a-synucleinopathies. The company also expects to complete an additional six screens in 2020.

3. GENMAB A/S

Copenhagen, Denmark-based Genmab A/S is an international biotechnology company specializing in antibody therapeutics for the treatment of cancer and other diseases.

The company has offered to sell 27.8 million American Depositary Shares or ADSs in the offering at an expected price of $18.11 per ADS, and the underwriters have an option for 30 days to purchase up to 4.17 million additional ADSs.

The company's ADSs have been approved for listing on the Nasdaq Capital Market under the symbol "GMAB." on July 18, 2019. Genmab is currently listed on the Nasdaq Copenhagen under the symbol "GEN" and on the US OTC as OTCPK:GMXAY.

The company has a commercial license and collaboration agreement with Seattle Genetics and research collaboration and license agreement with Immatics Biotechnologies. The company also has partnerships with ADC Therapeutics, BioNTech, Bristol-Myers Squibb, Lundbeck and Horizon Pharma.

Underwriters of the IPO:

BofA Securities, Morgan Stanley, Jefferies, Guggenheim Securities,RBC Capital Markets, Danske Markets, H.C. Wainwright & Co., Kempen & Co U.S.A., Inc.

Marketed products:

Genmab's lead drug, daratumumab, marketed by Janssen Biotech under the brand Darzalex, is a human IgG1k monoclonal antibody for the treatment of patients with multiple myeloma (MM).

The second commercial product is Arzerra (ofatumumab), developed and marketed with Novartis, is a human IgG1k monoclonal antibody for the treatment of chronic lymphocytic leukemia (CLL).

Pipeline:

The proprietary clinical product pipeline includes Tisotumab vedotin, Enapotamab vedotin, HexaBody-DR5/DR5 (GEN1029) and DuoBody-CD3xCD20 (GEN3013).

Tisotumab vedotin is under phase II trials in patients with solid tumors.

Enapotamab vedotin, GEN1029 is under a phase I/II trial in a mixed population of patients with specified solid tumors.

GEN3013 is under a phase I/II trial in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.

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