Analyst Conference Summary

conference date: November 2, 2015 @ 5:30 AM Pacific Time
for quarter ending: September 31, 2015 (Q3, third quarter 2015)

Forward-looking statements

Overview: Progress continues to be made on the Accurin pipeline of this development stage biotechnology company. Partners will pay milestones for 2 therapies in Q4.

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 $2.1 million, down sequentially from $2.5 million, and down from $3.4 millon year-earlier.

Net income was negative $10.2 million, up sequentially from negative $10.5 million, and down from negative $7.3 million year-earlier.

EPS diluted was negative $0.49, up sequentially from negative $0.51, and up from negative $1.44 year-earlier.

Guidance:

none

Conference Highlights:

Andrew Hirsch, president and CEO at Bind Therapeutics stated "Interim phase 2 data is forthcoming on our lead product BIND-014 in two studies across six tumor types with limited treatment options, starting with a readout by the end of 2015 in KRAS mutant and squamous histology non-small cell lung cancers. In addition, Pfizer exercised an option in our collaboration to move a kinase inhibitor towards clinical development and we expect our collaboration with AstraZeneca to result in a second Accurin to enter the clinic in the fourth quarter."

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, which is fully enrolled. Bind is now enrolling patients in a Phase 2 iNSITE 1 trial for non-small cell lung cancer with KRAS mutations and squamous histology. First data readouts could come before the end of 2015. A second stage of the study will begin enrolling if the gating criteria are met.

A Phase 2 trial of BIND-014 in multiple tumor types first patient was dosed in "the iNSITE 2 trial in patients with four tumor histologies, each affecting fewer than 200,000 patients in the U.S.: cholangiocarcinoma, advanced cervical cancer, advanced bladder cancer, and advanced squamous cancer of the head and neck." Patients in all four tumor types are now enrolling.

In collaboration with AstraZeneca AZD-2811 should go into Phase 1 in Q4 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.

Pfizer will option its first Accurin candidate, of 2 planned, for solid tumors. Bind expects to receive a $2.5 million option fee in Q4.

Collaboration agreement with Macrophage Therapeutics (a unit of Navidea Biopharmaceuticals) and should have proof-of-concept results before the end of 2015. Multiple versions of accurins are now available for testing.

The company hopes to finish BIND-510 preclinical studies this year and file for an IND in 2016. Preclinical data will be presented at a conference in Q4.

Bind continued preclinical work, and generated promising initial data, on Accurin versions of anti-infective and oligonucleotide-based therapies.

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 $41.9 million, down sequentially from $53.4 million. Long term debt was $10.8 million and warrant liability was $5.7 million. $3 million was used for one-time capital expenditures, mostly for the manufacturing facility.

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 $13.6 million consisted of $9.7 million for research and development and $3.9 million for general and administrative. Loss from operations was $11.5 million. Other gain was $1.4 million.

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:

Given good clinical results, are you operationally ready to roll into pivotal studies? Accruals in trials to date have been up to expectations. We believe there will be interest in this drug if gating criteria are met. The key decision might be whether to go forward as a monotherapy or go with a combination therapy. We would look for an ex-US partner.

Antibiotics partner? We are doing that on our own with an off-patent therapy.

Oligonucleotide partner? Yes, that is more complex, we would like to have a partnership.

What would a pivotal trial in KRAS look like? 300 could be a reasonably sized trial. But pointed to a 600 patient trial. So would want a global partner.

Prostate cancer, has median overall survival been determined? We are intrigued and impressed by the data. But what is the roll of taxanes now that there are androgen pathway inhibitors? We are close to the 75% survivor threshhold. In data released in early 2016 we should see median overall survival and other markers.

510 target types to be revealed at the meeting? Yes. 5 target types, each better than the other.

iNSITE 2 data, number of patients? First stage data could be as many as 2 tiers out of 4. Accrual is going well, but it is early to make projections.

Payments in Q4? We would use the performance method, so the revenue would be recognized over several years.

Given the broad potential applications, what will be the company focus? 014 combined with an anti-PD1 appears to be the most attractive at this point. Our overall focus will remain in oncology.

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