Genmab, a Danish developer of antibody therapeutics for cancer and other diseases, has disclosed plans to raise $500 million through an American initial public offering, according to a registration statement filed with the U.S. Securities and Exchange Commission.

Genmab has yet to spell out how much in net proceeds it expected to generate—which would depend on how much money the company agrees to raise in the IPO—or how much it would set aside toward any of several purposes outlined in its F-1 registration statement, filed late yesterday.

In that statement, Genmab said it plans to offer American Depositary Shares on the Nasdaq Global Select Market under the symbol “GMAB.”

The company already trades its shares on the Nasdaq Copenhagen exchange—where its share price fell 4.81% in trading earlier today, to DKK 1158 ($172.92) as of 3:07PM CEST, from yesterday’s closing price of DKK 1216.50 ($181.65).

Genmab’s portfolio includes two marketed treatments co-developed with partners. One is Darzalex® (daratumumab), the first human CD38 mAb to reach the market and the first mAb to receive FDA approval to treat multiple myeloma, developed with and marketed by Johnson & Johnson’s Janssen Biotech. The other is Arzerra® (ofatumumab) for certain indications of chronic lymphocytic leukemia, developed with and marketed by Novartis.

“Our vision is to transform cancer treatment by launching our own proprietary product by 2025 and advancing our pipeline of differentiated and well-tolerated antibodies,” Genmab stated in the F-1 filing.

Five proprietary candidates

That pipeline, Genmab said, includes five proprietary product candidates in clinical development, and approximately 20 proprietary and partnered preclinical programs, including two proprietary product candidates for which the company has either submitted or intends to submit an IND application to the FDA, and/or a clinical trial application (CTA) to the European Medicines Agency in 2019.

Among Genmab’s proprietary antibody candidates are HexaBody-DR5/DR5 (GEN1029), for which the company dosed its first patient in a Phase I/II clinical in May 2018; and DuoBody-CD3xCD20 (GEN3013), for which the first patient was dosed in a Phase I/II study of a subcutaneous formulation for the treatment of B-cell malignancies in July 2018.

GEN1029 consists of two non-competing HexaBody molecules designed to target two distinct epitopes on death receptor 5 (DR5) a cell surface receptor that mediates a process called programmed cell death. GEN1029 was developed with the company’s proprietary HexaBody technology.

GEN3013 is a bispecific antibody therapeutic candidate created using Genmab’s proprietary DuoBody technology. DuoBody-CD3xCD20 is designed to target CD3, which is expressed on all T-cell subtypes and is part of the T-cell receptor, and CD20.

Another proprietary candidate is the Genmab-owned Enapotamab vedotin (HuMax®-AXL-ADC), which is in Phase I/II development for multiple types of solid tumors: ovarian, cervical, endometrial, thyroid, non-small cell lung cancer, melanoma, and sarcoma. Enapotamab vedotin is an antibody-drug conjugate (ADC) targeted to Axl (from anexelekto, or uncontrolled growth), using ADC technology licensed from Seattle Genetics.

Seattle Genetics is Genmab’s development partner for another candidate, tisotumab vedotin, which is in Phase II in cervical cancer, ovarian cancer, and solid cancers. Tisotumab vedotin is an ADC targeted to tissue factor (TF), a protein involved in tumor signaling and angiogenesis

In addition to Seattle Genetics and Janssen, Genmab’s pipeline also includes candidates partnered with ADC Therapeutics, BioNTech, Bristol-Myers Squibb, Lundbeck, and Horizon Pharma.

One late-stage partnered candidate is teprotumumab, a fully human antibody developed by Genmab under its collaboration with Roche—which has licensed to Horizon Pharma clinical development of the candidate in Graves’ orbitopathy (thyroid eye disease).

Phase III success

On April 26, Horizon trumpeted successful results from the Phase III OPTIC trial (NCT03298867) in two secondary endpoints that showed a significant reduction in proptosis (eye bulging) and a substantial improvement in overall response rate in patients treated with teprotumumab compared with placebo. On February 28, Horizon said tepromumumab met the study’s primary endpoint with 82.9% of treatment-arm patients achieving a 2 mm or more reduction in proptosis vs. 9.5% of placebo patients.

Most of Genmab’s pipeline consists of partnered products, led by new indications for Darzalex, now in multiple Phase III studies in smoldering, frontline and relapsed multiple myeloma as well as in amyloidosis. According to Genmab, additional studies are ongoing or planned to assess Darzalex in natural killer/T-Cell lymphoma (NKTCL) nasal type, and B-cell and T-cell acute lymphoblastic leukemia.

Also in Genmab’s pipeline are subcutaneous formulations of its two marketed products: Darzalex for multiple myeloma and amyloidosis, and Arzerra for relapsing multiple sclerosis.

The Janssen-partnered Darzalex was launched in the U.S. in 2015, and remains Genmab’s proverbial cash cow. Last year, Darzalex-related royalties and milestone payments from Janssen accounted for 75.8% of Genmab’s revenue, compared to 90% in 2017. Genmab recorded $90 million in milestone payments and DKK 1708.1 million ($262 million) in royalties related to Darzalex sales in 2018, according to the IPO filing.

Those milestone payments and royalties were based on Darzalex achieving $2 billion in 2018 net sales, up from $1.2 billion in 2017.

Janssen royalties leaped to 84.9% of Genmab’s DKK 591 million ($88.2 million) in revenue—approximately $74.9 million— in the first quarter of this year, during which Genmab received no milestone payments.

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