A company called AC Immune has just filed its F-1 paperwork with the U.S. Securities & Exchange Commission (SEC) to pursue an initial public offering (IPO). The filing is for up to $50 million in common stock, and AC Immune intends to list its common shares on the Nasdaq under the symbol ACIU.
No other financial details were included in the filing. It listed Credit Suisse, Jefferies and Leerink Partners as underwriters.
Investors should know that this is a pre-revenue, clinical stage biopharmaceutical company. It has two proprietary technology platforms to discover, design and develop novel, proprietary medicines for prevention, diagnosis and treatment of neurodegenerative diseases associated with protein misfolding.
The company’s filing indicated that misfolded proteins are generally recognized as the leading cause of neurodegenerative diseases, such as Alzheimer’s and Parkinson’s diseases. It said:
We believe that our large and diverse pipeline of seven therapeutic candidates, including three clinical-stage candidates and three diagnostic candidates, has the potential to drive a paradigm shift in the treatment of a broad spectrum of neurodegenerative and other diseases related to protein misfolding.
Alzheimer’s is said to have an estimated worldwide patient population of 47 million in 2015. That population is projected to grow to 75 million by 2030, and then to 132 million by 2050, according to the World Alzheimer Report 2015.
AC Immune has partnerships with Genentech and Biogen in various stages. The filing further said:
Our lead product candidate is crenezumab, a humanized, monoclonal, conformation-specific anti-Abeta antibody that we developed using our proprietary SupraAntigenTM platform. Crenezumab commenced Phase 3 clinical studies in the first quarter of 2016 and we believe it has the potential to become a best-in-class disease-modifying treatment for AD. Genentech, Inc., a wholly owned subsidiary of Roche, or Genentech, is advancing crenezumab for the treatment of AD under a collaboration agreement with us, pursuant to which it is responsible for the clinical development of crenezumab, including the costs associated with seeking and obtaining regulatory and marketing approvals, manufacturing costs and sales and marketing costs. Under our collaboration agreement, we are eligible to receive payments from Genentech totaling up to approximately $340 million, as well as sales royalties. Crenezumab has received Fast Track designation from the FDA. The Fast Track program is intended to expedite or facilitate the process for reviewing new drugs that are designed to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs, as further described under “Business—Government Regulation and Our Regulatory Department—Product Approval Process.” In 2012, crenezumab was independently selected by the National Institute of Health, the Banner Alzheimer’s Institute and Genentech for use in the first-ever AD prevention study, which serves as the cornerstone of the global Alzheimer’s Prevention Initiative. While crenezumab did not meet its co-primary endpoints in its Phase 2 studies, the data showed promising signals of activity in patients with a milder stage of the disease.
If approved, crenezumab has the potential to treat the underlying cause of the disease and intervene at an earlier stage of AD progression, prior to irreversible neuronal damage. We believe that crenezumab is ideally positioned to be at the forefront of disease-modifying and preventive medicine.