On November 2, 2015 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, reported financial results and business highlights for the third quarter ended September 30, 2015 (Press release, BIND Therapeutics, NOV 2, 2015, View Source [SID:1234507868]). Management will host a conference call today at 8:30 a.m. ET to provide a business update and review the Company’s third quarter financial results.
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"This was an important quarter for BIND as we made significant progress with our proprietary pipeline, collaboration programs and research initiatives that have the potential to lead to breakthrough therapies," said Andrew Hirsch, president and chief executive officer at BIND Therapeutics. "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. We have also made tremendous progress in developing Accurins to target diseased immune cells, infectious disease, and to deliver oligonucleotides. Collectively, we are now positioned to potentially have at least four Accurins in clinical development within the next two years."
Recent Pipeline/Business Highlights:
Appointed Dr. Arthur Tzianabos, current president and chief scientific officer at OvaScience, to the Board of Directors.
Received notification from Pfizer that it would exercise its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors under the companies’ global collaboration agreement. BIND expects to receive the $2.5 million option fee in the fourth quarter of 2015.
Dosed the first patient 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.
Completed build out of dedicated manufacturing space, through an arrangement with a large contract manufacturing organization, that is capable of producing Accurins at the double-digit kilogram scale.
Continued preclinical work in collaboration with Macrophage Therapeutics, completing derivatization of the Manocept targeting agent and producing multiple versions of Manocept-targeted Accurins for in vivo testing.
Continued preclinical work, and generated promising initial data, on Accurin versions of anti-infective and oligonucleotide-based therapies.
Anticipated upcoming milestones and activities include:
Dose the first patient in the phase 1 trial of AZD2811 with collaborator AstraZeneca. BIND expects to receive the $4.0 million milestone payment in the fourth quarter of 2015.
Present preclinical and clinical pharmacokinetic data from BIND’s clinical stage Accurin BIND-014, data from BIND’s preclinical stage Accurin BIND-510, and new data from a previously unannounced feasibility study with an Accurin formulation of Merck’s AKT inhibitor, MK-2206, at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper).
Report initial data from the first stage of the iNSITE 1 trial in KRAS mutant or squamous histology non-small cell lung cancer in the fourth quarter of 2015.
Report the results of ongoing proof-of-concept work with Macrophage Therapeutics before year-end.
Report overall survival data from the completed phase 2 non-small cell lung cancer study with BIND-014 in the broader patient population following occurrence of all survival events.
Report final results from the phase 2 prostate cancer study with BIND-014 following occurrence of 75 percent of the survival events.
Report initial stage 1 data readout from iNSITE 2 trial in the first half of 2016.
Initiate in vivo studies with Accurin containing an antibiotic that targets gram negative bacteria.
Initiate in vitro and in vivo studies aimed at characterizing the ability of Accurins to impact PK, biodistribution, cellular uptake and gene silencing activity of oligonucleotide drugs.
Third Quarter 2015 Financial Results
Revenue for the third quarter of 2015 was $2.1 million, compared to $3.4 million in the third quarter of 2014. Revenues are primarily related to collaborations with AstraZeneca, Pfizer and Roche. The decrease in 2015 third quarter revenue compared to 2014 third quarter revenue was primarily due to lower revenue recognized from the up-front license fee from the AstraZeneca collaboration. The Company uses a proportional performance model to recognize revenue related to the up-front license fees, milestones, option exercise fee, and research and development services. Revenue is recognized over estimated performance obligations over time – at times much later than when cash is received.
Research and development expenses totaled $9.7 million for the third quarter of 2015, compared to $7.1 million for the third quarter of 2014. The increase in research and development expenses was primarily driven by higher manufacturing and related expenses as we scaled up and completed the clinical manufacturing batch needed for Accurin AZD2811, as well as greater compensation expense to support the development of BIND’s internal pipeline and collaborations.
General and administrative expenses totaled $3.9 million for the third quarter of 2015, which was essentially flat when compared to the third quarter of 2014.
Net loss for the third quarter of 2015 was $10.2 million, compared to a net loss of $7.3 million for the third quarter of 2014.
Cash, cash equivalents and short-term investments were approximately $41 million as of September 30, 2015. Including the $2.5 million Pfizer option exercise fee and the anticipated R&D reimbursement for the next stage of the Pfizer collaboration, the Company expects that its cash, cash equivalents and short-term investments will fund operating expense and capital expenditure requirements into the fourth quarter of 2016. This expectation is based on BIND’s current operating plans and research and development funding that it expects to receive under its existing collaborations, but excludes any potential milestone payments under its collaboration agreements.
We expect to earn a $4.0 million milestone from AstraZeneca during the fourth quarter of 2015 for the first patient in a phase 1 trial for Accurin AZD2811. We only include milestones in our cash guidance once they are achieved.