conference date: November 10, 2015 @ 2:00 PM Pacific Time
for quarter ending: September 30, 2015 (Q3, third quarter 2015)
Overview: Clinical stage development company continued to make pipeline progress in the quarter.
Basic data (GAAP):
Revenue in the quarter was $1.6 million. There was no revenue in the year-earlier quarter.
Net loss was $23.2 million, down from $19.8 million year-earlier.
EPS (diluted) was negative $0.26, improved from negative $10.50 year-earlier.
2015 cash burn to be below $150 million.
The quarter was notable for the Celgene deal and pipeline progress.
Celgene entered into a ten-year collaboration agreement. Juno Therapeutics received a total of $1 billion, of which $150.2 was for the option to commercialize Juno products outside North America, and $849.8 million was a stock purchase at $93 per share. The deal closed on July 31, 2015.
Revenue in the quarter was recognized from the Celgene collaboration. "Celgene is already contributing to our clinical development plan."
The FDA accepted Juno’s investigational new drug (IND) application for JCAR015 for the treatment of adult patients with relapsed/refractory ALL (acute lymphoblastic leukemia). A Phase 2 study began in the quarter and could serve as Juno’s U.S. registration trial. Planning for an FDA submission for commercialization in 2017.
The JCAR017 Phase 1 study in relapsed/refractory B cell NHL (non-Hodgkin lymphoma) began in the quarter.
The FDA accepted Juno’s IND application for the MUC-16 & IL-12 “armored” CAR for patients with recurrent ovarian cancer. This technology has the potential to be applied more broadly.
JCAR014 data presented in September suggested clinical benefit in blood cancers CLL, NHL, and ALL. Expansion and persistence of cells has been demonstrated.
There will be presentations at ASH for Juno's therapies, including better CART cells and CTRs in the future. Abstracts have been published.
Other trials are ongoing. See Juno Therapeutics pipeline. Plans to have 9 product candidates against 6 targets by early 2016. A 10th product candidate should be in the clinic in later 2016.
Cash and equivalents balance ended at $1.27 billion, up sequentially from $313.4 million, largely due to the Celgene deal. $14.2 million was used to build out the manufacturing facility. Stock based compensation expense was $1.3 million. No debt.
Operating expense of $25.1 million consisted of: $11.5 million for R&D and $13.6 million for general and administrative. Operating loss was $23.5 million. Interest income $0.35 million. Income tax provision $63 thousand.
ASH abstracts, competitor with off-the-shelf CART competitor, your attitude to off-the-shelf? In the study you allude to the patient received a complete remission. From the abstract it is hard to differentiate the CART response from other therapy received. In itself the abstract really does not change our view on off-the-shelf approaches. We believe autologous approaches have the best chance of showing durable persistence.
Success payments, where would they be? Based on a 90-day trailing moving average. At the present price we would owe $85 million, with $75 million to Fred Hutchinson Cancer Center and $10 million to Sloan-Kettering. We have not decided between paying in stock or in cash.
Has the combo trial, NHL, with MedImmune 4736 started yet? Should start by end of year.
When might we get a Celgene update? Not at ASH, but could be news in 2016. We are off to a good start with them.
Cash burn thoughts for 2016? Our cash burn grew in 2016. We won't have the capital investments in the facility we had in 2016. We will have a larger set of therapies and trials driving R&D.
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