Analyst Conference Summary

conference date: March 15, 2016 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2015 (Q4, fourth quarter 2015)

Forward-looking statements

Overview: Announced shift in Research and Development strategy for Accurin pipeline. Sounds like RNA interference is part of it.

Note that Bind Therapeutics is a small-cap, clinical stage biotechnology company with no commercial products approved for sale yet.

Basic data (GAAP):

Revenue was $6.4 million, up sequentially from $2.1 million, and up from $3.0 million year-earlier.

Net income was negative $7.6 million, up sequentially from negative $10.2 million, and up from negative $8.5 million year-earlier.

EPS diluted was negative $0.37, up sequentially from negative $0.49, and up from negative $0.51 year-earlier.

Guidance:

none

Conference Highlights:

"Moving forward, BIND plans to focus on the development of therapeutics that leverage the ability of ACCURINS® to incorporate novel combinations of targeting ligands and unique payloads including oligonucleotides and potent kinase inhibitors, creating synergistic properties in a single particle."

Andrew Hirsch, president and CEO at Bind Therapeutics stated "Historically, nanoparticle-based therapies have used previously approved medicines as therapeutic payloads to provide equivalent efficacy with improved safety. Our new strategy leverages the unique attributes of ACCURINS®, specifically their ability to precisely target cells and tissues with ligand-mediated binding while containing high concentrations of novel therapeutic payloads."

Simply using nanotechnology to deliver older therapies has "seldom" resulted in improved clinical outcomes. So in 2015 Bind Therapeutics started shifting to a more advanced strategy, including the discovery of innovative medicines for delivery by Accurins.

Chief Science Officer Jonathan Yingling added "Following optimization of lead product candidates and completion of preclinical studies, we anticipate initiation of clinical testing for one or more of our proprietary innovative product candidates as early as 2018." The first Accurin immuno-oncology product concept should be identified in 2016. [WMP: this guy sounds like a game-changer for Bind to me]. Decided to discontinue development of Bind-510, to focus on ideas more-likely to succeed.

In the meantime Bind is committed to its already existing programs and partnerships.

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.

In April 2016 topline data from iNSITE 1 and 2 BIND-014 trials in SNCLC, cervical cancer and head and neck cancer. Next steps will be decided in Q2 when data is available. INSITE 1 trial patient enrollment completed in January.

The lead candidate is BIND-014, an Accurin that contains docetaxel, for prostate cancer, which is fully enrolled.

In collaboration with AstraZeneca AZD-2811, containing an Aurora B Kinase inhibitor, went into Phase 1 in Q4 triggering a $4 million milestone payment. Illustrates a case where accurins help a drug be more specific to its target.

Pfizer will option its first Accurin candidate, of 2 planned, for solid tumors. Bind expects to receive a $2.5 million option fee

Collaboration agreement with Macrophage Therapeutics (a unit of Navidea Biopharmaceuticals) and should have proof-of-concept results

By the end of 2017 Bind hopes to have preclinical proof of concept data for 3 programs. GI malignancies with guanylate cyclase-C receptors; delivery of single double stranded RNA fragment to achieve target knockdown; and achieving endosomal escape with RNA.

In February Bind entered into a collaboration agreement with Synergy Pharma for accurins for GI cancer.

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 and equivalents balance ended at $36.9 million, down sequentially from $41.9 million. Long term debt was $9/5 million and warrant liability was $2/9 million.

Cash should last through Q4 of 2016, or longer if milestone payments are received. Milestones are only included in cash guidance once they are received.

Operating expenses of $15.7 million consisted of $11.1 million for research and development and $4.6 million for general and administrative. Loss from operations was $9.3 million. Other gain was $1.6 million.

R&D expenses increased to support the BIND-014 trials.

Believe accurins can be made to carry antibiotic payloads. Also looking at oligonucleotide-based therapeutic payloads with accurins. Believes data supports pursuing multiple candidates.

The new dedicated manufacturing space was built out by a large contract manufacturing organization. It is capable of producing Accurins on a larger scale.

Q&A:

510 neurotoxic data not compelling? That was a major factor. It did not improve upon the side effects of the naked molecules.

Novel target strategy, is that driven by collaborators or internally? Driven by success of Merck and AZ partnerships. Novel therapies give reads early on, you don't have to do a head-to-head trial against a naked, already-approved drug.

Internal pipeline will focus on oncology, but there are non-oncology opportunities that we will work with partners.

Endosome escape problem? We are working on fixing that. We believe we have an approach that will work with siRNA.

014 hurdles to moving forward? Immuno-oncology is changing the approach to treatment and histology. The differentiation needs to be in the tumor environment vs. rest of body. So safe and tolerable plus immunogenic cell death. We are looking at areas where immunotherapy has established itself already. We are looking for opportunities for combinations. The key focus near-term will be squamous cell lung, head and neck cancer. For lung cancer we had median overall survival in our previous trial. Current trial will be looking at the disease control rate. We will have 40 patients worth of data. For head & neck, 20 patients, cervical 20 patients, so a 20% or more response would be good.

Oligos, upper limit of size within an accurin? We are working with up to about 30 nucleotides. We have already shown encapsulation and release. We think we could go into the low 100s. But not Kilo sized, not in the near term anyway. So single stranded for target knockdown, and double stranded when we solve the endosomal escape problem.

Pretty much siRNA competition, will you need to partner to avoid others IP? Near term, a partnering strategy. Long term, we would want our own payload creation capability.

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