In what will likely be the most closely watched IPO in biotech, biotech upstart Juno Therapeutics has rolled out a $150 million offering that is likely to make a big splash on the market.
Juno, a 2014 Fierce 15 company that launched just a year ago, is developing CAR-Ts and TCRs, engineered T cells intended to mount a personalized attack on cancer. And the Seattle-based biotech, which has already attracted $310 million in investment cash from a range of high-profile investors that includes Amazon's Jeff Bezos, isn't about to start underselling the technology now.
Juno, it says in its S-1, was "founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine." The biotech is one of the leading companies pioneering the use of genetic engineering to turn the immune system's T cells into cancer killers. And the biotech spelled out its three top candidates aimed at a rapid-fire clinical program and early approval:
- JCAR015, now in a Phase I clinical trial, has seen a "91% complete remission rate in 22 evaluable adult patients with relapsed/refractory B cell acute lymphoblastic leukemia, or r/r ALL, as of the most recent data cutoff date of July 1, 2014. Historical complete remission rates without JCAR015 in a similar population are less than 10%." Juno plans to start a Phase II trial in mid-2015 exploring JCAR015 in adult r/r ALL that could support accelerated U.S. regulatory approval.
- JCAR017 has achieved an 83% complete remission rate in 6 evaluable patients with pediatric r/r ALL as of August 1. "We plan to continue the ongoing Phase I/II trial in pediatric r/r ALL in 2015. Based upon data to date, we also plan to initiate a multicenter Phase I trial exploring JCAR017 in relapsed/refractory B cell non-Hodgkin's lymphoma, or r/r NHL, in 2015, with the potential to advance to a registration trial in 2016 that may support accelerated U.S. regulatory approval."
- JCAR014 is in a Phase I/II trial in patients with B cell malignancies, "with the vast majority of patients treated to date having either r/r NHL or r/r ALL. We expect to report data from the Phase I portion of this trial before the end of 2014. We plan to continue enrolling patients in the ongoing Phase I/II trial in 2015 in order to explore various treatment strategies to improve the multiplication and persistence of the CAR T cells in the body. As of the date of this prospectus, we do not plan to advance JCAR014 into registration trials."
And there are plans in place to start 4 more CAR-T and TCR programs by the end of 2015--with "Phase I testing of our first CD19-directed "armored" CAR in one or more B cell malignancies in 2015."
While Big Pharma has been focusing heavily on PD-1 and PD-L1 in immuno-oncology, this IPO is likely to prove once again that Juno is emerging as a major player using an incredibly promising cell technology in a related field. And Juno, which has a staff of 70, is up against one of the biggest rivals in the industry. Novartis ($NVS) has been bankrolling its own ambitious effort directed by investigators at the University of Pennsylvania.
In its corner, though, Juno can rely on leading investigators at Memorial Sloan-Kettering and the Fred Hutchinson Cancer Research Center, who originally helped birth the field.
Juno has burned through $76 million--with an "accumulated deficit" of $154 million under reporting rules--to get to this point, says a spokesperson. And the biotech doesn't plan to ease up on the gas anytime soon.
The work isn't without serious risks. Investigators for Juno have reported cases of severe cytokine release syndrome, a cytokine "storm" that spurs fever and has killed patients. Two patients died while being treated with JCAR015, forcing researchers to change their recruiting profile for patients and alter dosing regimens.
The IPO will make CEO Hans Bishop wealthy. Bishop was awarded 7.7 million shares to be vested over time, another 3.1 million shares in 2013 and the right to buy 4 million shares at $1.59 each. He also got a raise last year, and now makes $425,000 base pay with a bonus plan worth 40% of that. Mark Frohlich, the R&D chief, makes $400,000 a year with a 30% bonus plan in place.
Arch Venture Fund, one of the original backers, and managing partner Robert Nelsen--both credited with 46 million shares--stand to do well in the IPO, along with the Fred Hutchinson Cancer Research Center, which also owns a chunk of stock. CL Alaska L.P. and JT Line Partners L.P. have 105 million shares.
Juno plans to start trading on Nasdaq under the JUNO symbol.
- here's the S-1
Special Report: FierceBiotech's 2014 Fierce 15 - Juno Therapeutics