Analyst Conference Summary

Juno Therapeutics

conference date: May 4, 2017 @ 2:00 PM Pacific Time
for quarter ending: March 31, 2017 (Q1, first quarter)

Forward-looking statements

Overview: Pipeline development continues. Earliest possible product approval is 2018, but has plenty of cash to get there.

Basic data (GAAP):

Revenue in the quarter was $19.3 million, down sequentially from $21.2 million and up from $9.8 million in the year-earlier quarter.

Net loss was $82.2 million, down sequentially from a loss of $55.7 million, and down from a loss of $71.1 million year-earlier.

EPS (diluted) was negative $0.79, down sequentially from negative $0.51, and down from negative $0.72 year-earlier.


Reaffirmed 2017 cash burn guidance if $270 to $300 million.

Conference Highlights:

Hans Bishop, CEO, said "We continue to advance our pipeline more broadly with eleven product candidates now in human testing. Already this year, we have initiated a number of trials, including a BCMA CAR T, a CD19-directed 4-1BBL armored CAR, a fully-human CD19 CAR T, a combination trial with JCAR014 and durvalumab, and a combination trial with JCAR014 and ibrutinib. With up to 20 ongoing trials by year end, we expect to gain additional insights that may lead to product candidates that can deliver long-term durable remissions for patients in need.”

"We believe that the type of CAR T cell matters, and we have invested in the types of technologies needed to control the type of cell in the final product."

Revenue is mostly from the Celgene partnership on CD19 therapies.

The JCAR017 for relapsed/refractory B cell NHL (non-Hodgkin lymphoma) trial continues to enroll. Updated DLBCL data will be presented at ASCO in June (TRANCEND trial), and enrollment continues. Will start a trial as a monotherapy for CLL later this year.

JCAR014 continued a Phase 1b combination trial with MedImmune's PD-L1 investigational agent durvalumab for r/r NHL. A cohort of 014 combined with ibrutinib is planned to began enrollment in Q1 for DLBCL. Began a combination trial with ibrutinib in CLL. Will also start a trial in combination with JCAR017.

JCAR018 (CD22) in a Phase 1 trial for r/r ALL interim data for 3 patients showed all remained in complete remission. But there was dose-limiting neurotoxicity. The trial continues to enroll patients.

JTCR016 for refractory mesothelioma so far of three patients only one had a partial response, but good safety.

Juno began enrolling patients in a Phase I trial in certain adult B cell malignancies, including r/r NHL, for a CD19 product candidate that incorporates a fully human binding domain.

Juno began a Phase I trial in r/r B cell malignancies for its CD19/4-1BB ligand armored CAR.

"Juno continues trials for solid tumor product candidates against five different targets - JCAR024 (ROR-1-directed CAR T), JCAR020 (MUC-16-directed armored CAR T engineered to secrete IL-12), JCAR023 (L1-CAM-directed CAR T), JTCR016 (WT-1- directed TCR) and a Lewis Y-directed CAR." There are hurdles in solid tumors, the first is to validate targets.

BCMA CAR T program initiated in Q1 for myeloma.

A fully human binding domain could help with persistence of effectiveness; a test could take place this year.

See Juno Therapeutics pipeline.

Cash and equivalents balance ended at $851 million, down $71 million sequentially from $922 billion. Cash burn for the quarter was about $75 million, excluding business development, u including $21 million to build out the headquarters facility. No debt.

Operating expense of $103.7 million consisted of: $82.9 million for R&D and $20.7 million for general and administrative. Operating loss was $84.3 million. Interest income $1.7 million. Other expense $0.9 million. Income tax benefit $1.3 million.

Juno has adequate cash "to last us into the next decade."

Juno continues to do fundamental science research on immune system cells that could help make more effective cancer therapies.

Q&A: [note this is my summary, not a transcript]

How is your BCMA CAR T differentiated from competitors? We have a strong understanding of the target, which can be heterogeneous. We have 2 fully human candidates which binds to the membrane form of the target. Co-stimulatory domain and linker are also important.

JCAR 014 + durvalumab study should have preliminary data at ASH this year.

We are investing in technologies that should be able to make CAR T cells in two days.

How do you plan to move forward with the JCAR 014 programs when you don't intend to commercialize it? It is a translational laboratory and it generates good results for patients. We can apply the results to JCAR 017, which can be thought of as the commercial version of JCAR 017.

Pediatric ALL, JCAR 017 update? There will be some data from SCRI later this year. We are in development with our partners on that program, we intend to have a plan by year-end.

JCAR 017 like candidate? We have some variations on JCAR 017, like one with a human binder. The question is which is best to move forward with, possibly a combination of them. Adult ALL has a narrow therapeutic window, so selectivity is particularly important in that indication.

DLBCL competitive landscape, with possibly 2 competitors ahead? First trial has to be in relapsed/refractory setting, designed to support accelerated approval.

The difference between the BCMA CAR T therapies is the defined cell manufacturing process, the molecular construct for the transgene, and two different bindings.

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Disclaimer: My analyst call summaries may include both our condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. This is investment journalism, not financial advice.

Copyright 2017 William P. Meyers