Juno Therapeutics, a heavily funded biotech company with a novel approach to fighting cancer, filed plans for an initial public offering today — seeking to raise at least $150 million on top of the $314 million already put into the company by venture capital firms and investors including Amazon CEO Jeff Bezos.
It’s the latest step in a meteoric rise for the Seattle-based company, which was founded a little more than a year ago as a spin-out of the Fred Hutchinson Cancer Research Center, Memorial Sloan-Kettering Cancer Center and Seattle Children’s Research Institute.
Juno Therapeutics has quickly become a standout in the Seattle biotech industry, an example of the region’s potential to harness its expertise and innovations from top institutions to address problems on a massive scale. The company is led biotech vet and former Dendreon exec Hans Bishop.
Juno takes a cancer patient’s T-cells, a key part of the immune system, and reprograms them using genetic engineering to fight that person’s cancer. The approach promises an alternative to radiation and chemotherapy for cancer patients.
Juno’s product candidates are in various stages of clinical trials, as the company lays the groundwork to seek regulatory approval. The company says in the filing that initial regulatory approval could come in the U.S. as soon as 2017, if data from the clinic trials is positive.
“Our current focus is to create best-in-class cancer therapies using human T cells as therapeutic entities,” the company says in its S-1 registration filing. “Our longer-term goal is to revolutionize medicine through the application of cell-based therapies. In particular, we believe that genetically-engineered T cells have the potential to meaningfully improve survival and quality of life for cancer patients.”
The company also faces significant risk and expense, noting in its filing that its accumulated deficit was $154.4 million as of September of this year. Juno had 70 employees as of that date, according to the filing. The company, which has yet to generate any product revenue, posted a net loss of more than $51 million for the first nine months of the year.
Here’s how the filing explains the company’s commercialization plans.
In the United States, there are approximately 6,000 patients diagnosed with ALL (acute lymphoblastic leukemia) and 70,000 patients diagnosed with NHL (Non-Hodgkin’s lymphoma) each year. If any of our CD19 (the protein targeted in cancer treatments) product candidates are approved, we expect to commercialize those products in the United States with a focused specialty sales force targeting the 41 hospitals and clinics designated as Comprehensive Cancer Centers by the National Cancer Institute. We believe we can address physicians who treat our proposed clinical indications with a direct specialty sales force.
Outside the United States, we have not yet defined our regulatory and commercial strategy for our CD19 product candidates. We expect to outline our plan in at least the EU in 2015. Our commercial strategy for markets outside the United States may include the use of strategic partners, distributors, a contract sales force or the establishment of our own commercial structure. We plan to further evaluate these alternatives as we approach approval for one of our product candidates.
As additional product candidates advance through our pipeline, our commercial plans may change. In particular, some of our pipeline assets target potentially large solid tumor indications. Data, the size of the development programs, the size of the target market, the size of a commercial infrastructure, and manufacturing needs may all influence our U.S., EU, and rest-of-world strategies.