Posted in | Nanomedicine | Nanobusiness

BIND Provides Update on BIND-014 Clinical Development Plan and Reports 1Q 2014 Financial Results

Published on May 9, 2014 at 7:52 AM

BIND Therapeutics, Inc., a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called AccurinsTM, today reported financial results for the first quarter ended March 31, 2014.

“We are very excited about recent developments for BIND-014, our lead proprietary drug candidate. In a planned interim analysis of the non-small cell lung cancer (NSCLC) Phase 2 trial for BIND-014, we observed promising preliminary clinical results in six patients with KRAS mutations and intend to add an additional clinical study to further investigate this promising clinical result. We were also pleased by the substantial interest generated in the medical and scientific community by the data we presented at the American Association for Cancer Research (AACR) 2014 Annual Meeting. Additionally, we completed enrollment in the BIND-014 Phase 2 NSCLC trial on the once every three week schedule and initiated enrollment in the weekly schedule,” said Scott Minick, BIND’s President and CEO.

“Looking forward in 2014, we plan to further evaluate BIND-014’s activity in additional patient populations, including NSCLC patients with KRAS mutations, and additional tumor types in which there is strong biologic rationale for BIND-014 treatment including cervical, bladder, cholangio and neuroendocrine cancer, as well as exploring potential biomarkers of PSMA expression, tumor permeability and particle accumulation.”

Recent Business Highlights

  • Performed a pre-specified evaluation of patients enrolled in the Phase 2 NSCLC trial with KRAS (Kirsten rat sarcoma viral oncogene homolog) mutations, given the historical lack of activity of docetaxel in this patient population. Of the six patients with KRAS mutations treated with BIND-014, two demonstrated a confirmed partial response and two had durable stable disease, which we define as lasting twelve weeks or longer. The KRAS gene is involved in regulating cell division and belongs to a class of genes known as oncogenes, which when mutated, have the potential to cause normal cells to become cancerous.
  • Presented three posters at the AACR 2014 Annual Meeting, including clinical data from a completed Phase 1 study demonstrating differentiating attributes of BIND-014 administered with a weekly dosing schedule which may enable increased dose intensity and enhanced therapeutic efficacy of BIND-014. Data supporting the potential utility of PSMA as a target and marker for BIND-014 patient selection were also presented. In addition, BIND and its collaborator AstraZeneca presented preclinical results of their Accurin Aurora B kinase relative to AstraZeneca’s parent drug.
  • Completed patient enrollment in the BIND-014 Phase 2 NSCLC clinical trial on the once every three week dosing schedule and have initiated enrollment in the weekly schedule. Two dosing schedules of BIND-014 are being evaluated in this trial, 60 milligrams per meter squared dosed on day one of a twenty-one day schedule and 40 milligrams per meter squared dosed on day one, eight and fifteen of a twenty-eight day schedule.
  • Nominated Charles Rowland, most recently Vice President and Chief Financial Officer of ViroPharma Inc., for election to BIND’s Board of Directors. Mr. Rowland has experience in finance, business development and accounting, including senior management responsibilities at Endo Pharmaceuticals, Pharmacia, Novartis and Bristol-Myers Squibb.

First Quarter 2014 Financial Results

  • Revenue for the first quarter of 2014 was $1.6 million, compared to $1.5 million for the first quarter of 2013. Research and development expenses totaled $6.8 million for the first quarter of 2014, compared to $5.7 million for the first quarter of 2013. The increase was primarily due to increased compensation expenses related to headcount growth associated with activities supporting the development of BIND’s internal pipeline and collaborations. General and administrative expenses totaled $3.3 million for the first quarter of 2014, compared to $2.0 million for the first quarter of 2013. The increase was primarily due to increased compensation expenses and external consulting expenses. Net loss for the first quarter of 2014 was $8.3 million, compared to a net loss of $6.3 million for the first quarter of 2013.
  • Cash, cash equivalents and marketable securities was $68.7 million as of March 31, 2014.

Upcoming Events and Presentations

Members of BIND’s management team are expected to participate in the following upcoming conferences during the second quarter:

  • UBS Global Healthcare Conference in New York (presenting at 11:00 a.m. ET on Monday, May 19, 2014).
  • Jefferies 2014 Global Healthcare Conference in New York (presenting at 1:30 p.m. ET on Monday, June 2, 2014).
  • JMP Securities Healthcare Conference in New York from Tuesday, June 24 - Wednesday, June 25, 2014).

Live and archived webcasts of these events will be made available on the Company’s website at www.bindtherapeutics.com.

Conference Call Information

BIND’s management team will host a conference call and audio webcast today at 8:30 a.m. ET to discuss the first quarter 2014 results and provide a corporate update. To access the conference call, please dial 877-312-5844 (domestic) or 253-237-1152 (international) at least five minutes prior to the start time and refer to conference ID 29247214.

An audio webcast of the call will also be available on the Investors & Media section of the Company’s website www.bindtherapeutics.com. An archived webcast will be available on the Company’s website approximately two hours after the event and will be available for 30 days.

Source: http://www.bindtherapeutics.com/

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