May 8 2015
BIND Therapeutics, Inc., a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, today reported financial results and business highlights for the quarter ended March 31, 2015.
"We had a strong start to 2015 and executed across all phases of our business,” said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. “We are now actively enrolling both cohorts of the phase 2 iNSITE 1 trial in patients with KRAS mutations and squamous histology non-small cell lung cancer and we expect to begin enrolling our phase 2 iNSITE 2 trial of BIND-014 in multiple tumor types in the second quarter. We have also completed much of the pre-IND work in collaboration with AstraZeneca on Accurin AZD2811 and anticipate entering the clinic in the second half of the year. We believe that our current dataset across multiple species, including data recently presented at AACR by us and our collaborators, validates the mechanism of our Accurins and their ability to deliver potentially superior product profiles.”
During the first quarter of 2015, BIND enrolled the first non-small cell lung cancer (NSCLC) patient with KRAS mutation and the first patient with squamous histology in the iNSITE 1 (BIND-014 Nanoparticle Study In Patients with Advanced KRAS Mutant or Squamous NSCLC to Determine Tolerability and Efficacy) phase 2 clinical trial.
Additionally, the Company achieved a development milestone in its collaboration with AstraZeneca and recently presented positive preclinical data at the American Association for Cancer Research (AACR) Annual meeting related to Accurin AZD2811, an Aurora B kinase inhibitor, demonstrating improved efficacy and enhanced transport to tumor sites in multiple preclinical models while displaying minimal bone marrow toxicity. Also presented at the AACR conference were positive clinical and preclinical data demonstrating that BIND-014 provided prolonged circulation and controlled release of encapsulated docetaxel, when compared to conventional docetaxel, consistently across multiple species.
“We are pleased with the progress of our mid-stage clinical trials year-to-date and anticipate initial data readouts from the iNSITE 1 trial in the second half of 2015,” said Hagop Youssoufian, M.Sc., M.D., chief medical officer at BIND. “In addition, we are on track to enroll the first patient in the iNSITE 2 trial in multiple tumor types and our collaborator AstraZeneca remains on track to begin clinical development of Accurin AZD2811 later this year. This Accurin incorporates a potent Aurora B kinase inhibitor, and promising preclinical results in both liquid and solid tumors were recently presented at AACR, further validating the ability of our Accurins to target diseased cells and control the bio-distribution of therapeutic payloads.”
Anticipated 2015 Milestones Include:
- Complete enrollment and report initial clinical results from the first evaluable patients in the first tier of the iNSITE 1 trial in the second half of 2015, with continued readouts in 2016.
- Initiate the iNSITE 2 (BIND-014 Nanoparticle Study In Patients with Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, and Squamous Cell Carcinoma of the Head and Neck to Determine Tolerability and Efficacy) trial, a phase 2 multi-tumor trial with BIND-014 in patients with tumor types of high unmet need in the second quarter of 2015.
- File Investigational New Drug (IND) application for AZD2811 with the U.S. Food and Drug Administration (FDA) in mid-2015 and enroll first patient in the clinical program.
- Report final overall survival data from the phase 2 trial with BIND-014 in the broad NSCLC and mCRPC populations in 2015.
- Advance BIND-510 through important preclinical studies to position it for an IND filing in 2016.
First Quarter 2015 Financial Results
Revenue for the first quarter of 2015 was $4.4 million, compared to $1.6 million for the first quarter of 2014, primarily due to increased reimbursable research and development activities for its AstraZeneca and Pfizer collaborations, as well as increased recognition of up-front license fee and milestone revenue. The Company also earned a $1 million development milestone under its collaboration with AstraZeneca during the first quarter of 2015.
Research and development expenses totaled $8.2 million for the first quarter of 2015, compared to $6.8 million for the first quarter of 2014. The increase was primarily driven by greater process development and manufacturing expense as the Company scales up its clinical material manufacturing capability and associated headcount to support the advancement of BIND’s internal pipeline and collaboration programs.
General and administrative expenses totaled $4.8 million for the first quarter of 2015, compared to $3.3 million for the first quarter of 2014. The increase was primarily related to a non-recurring cash and stock-based compensation charge for the March 2015 resignation of BIND’s former president and chief executive officer.
Net loss for the first quarter of 2015 was $8.3 million, compared to a net loss of $8.3 million for the first quarter of 2014.
Cash, cash equivalents and short-term investments were approximately $63 million as of March 31, 2015. The Company expects that its cash, cash equivalents and short-term investments as of March 31, 2015 will fund operating expenses and capital expenditure requirements through the first half of 2016. This expectation is based on the Company’s current operating plans and research and development funding that it expects to receive under its existing collaborations, but excludes any potential milestone payments.
Source: http://www.bindtherapeutics.com/