Bind Therapeutics
BIND
conference date: August 6, 2015 at 5:30 A.M. Pacific Time
for quarter ending: June 30, 2015 (Q2, second quarter 2015)
Forward-looking
statements
Overview: Progress continues to be made on the pipeline of this development stage biotechnology company.
Basic data (GAAP):
Revenue was $2.5 million, down sequentially from $4.4 million, and flat from $2.5 millon year-earlier.
Net income was negative $10.5 million, down sequentially from negative $8.6 million, and down from negative $8.5 million year-earlier.
EPS diluted was negative $0.51, down sequentially from negative $0.44, and flat from $0.51 year-earlier.
Guidance:
none
Conference Highlights:
BIND has collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck & Co., or Merck to develop Accurins based on their proprietary therapeutic payloads and targeting ligands. Bind also has proprietary, unpartnered programs.
The lead candidate is BIND-014, an Accurin that contains docetaxel, for prostate cancer. Bind is now enrolling patients in a Phase 2 trial for non-small cell lung cancer with KRAS mutations and squamous histology. First data readouts could come before the end of 2015. Another Phase 2 trial in multiple tumor types will enroll its first patient this quarter.
In collaboration with AstraZeneca AZD-2811 should go into Phase 1 in Q4 or the first quarter of 2016, triggering a $4 million milestone payment. Positive pre-clinical data was presented at the AACR meeting. Illustrates a case where accurins help a drug be more specific to its target.
In September potentially Pfizer will select its first Accurin candidate, of 2 planned.
Entered into a collaboration agreement with Macrophage Therapeutics (a unit of Navidea Biopharmaceuticals) and should have proof-of-concept results before the end of 2015.
The company hopes to finish BIND-510 preclinical studies this year and file for an IND in 2016.
See also the Bind Therapeutics Pipeline page
Revenue in the quarter was from reimbursement of R&D expenses by partners and from partial recognition of license fee and milestone revenue. Recognized over a performance period.
Cash balance ended at $53.4 million, down sequentially from $63 million. Long term debt was $12.1 million and warrant liability was $7.4 million.
Cash should last through the first half of 2016, or longer if milestone payments are received.
Operating expenses of $12.7 million consisted of $8.3 million for research and development and $4.4 million for general and administrative. Loss from operations was $10.1 million. Other expense was $0.3 million.
Believe accurins can be made to carry antibiotic payloads. Also looking at oligonucleotide-based therapeutic payloads with accurins.
Q&A:
Oligo payload, would you partner? Potentially. Several companies are trying to solve this problem. We are focused on establishing proof of concept, then we could choose a path forward. We want to show efficacy in non-liver models in preclinical work.
Total milestones possible for the collaborations is $193 million.
Data releases would be at a medical meeting. We'll let you know.
What would be the announceable event in Q4? From the KRAS mutant cohort, which started earlier. Both cohorts are accruing according to expectations. We should have 20 patients' worth of data by Q4, we could then expand to an additional 20 patients. The threshold to aim for would be a 60% disease control rate. The first data would be whether it was futile or whether we could move forward.
Macrophage collaboration? Demonstrating the efficacy of an accurin would be the first test. Then we would look at payloads. Macrophage has a key, relatively unexplored component of a tumor environment. CD206 is often overexpressed in both macrophages and dendritic cells, but binding could be differenitable, and with subgroups of macrophages as well.
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