On May 9, 2016 BIND Therapeutics, Inc. (NASDAQ:BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS, reported financial results for the first quarter ended March 31, 2016 and provided a business update (Press release, BIND Therapeutics, MAY 9, 2016, View Source [SID:1234512102]). Schedule your 30 min Free 1stOncology Demo! "Despite our financial challenges, we remain committed to advancing our new R&D strategy of applying our ACCURINS technology to develop innovative medicines and we have made significant progress during the first quarter," said Andrew Hirsch, president and chief executive officer at BIND Therapeutics. "In order to address these challenges, we took difficult but necessary steps to substantially reduce our operating expenses, focus the business, and explore strategic and financial alternatives. Despite these efforts, we filed for Chapter 11 protection to provide the necessary time to pursue these alternatives to the benefit of all stakeholders. While the Chapter 11 process can be distracting, we don’t anticipate any major disruptions in our business operations during this process."
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Scientific Highlights:
Discovery Pipeline:
During the quarter, BIND initiated in vivo studies aimed at characterizing the ability of ACCURINS to affect pharmacokinetic, biodistribution, cellular uptake and gene silencing activity of oligonucleotide therapeutics. In addition, the Company has initiated formulation efforts to develop ACCURINS containing small molecule inhibitors of TGF-beta signaling.
In addition, BIND has recently entered into several strategic research collaborations to quickly and efficiently evaluate novel targeting ligands as part of our strategy to develop ACCURINS that incorporate combinations of targeting ligands and therapeutic payloads, including a variety of biologically active ligands. These collaborations include:
Synergy Pharmaceuticals, for access to ligands that can target gastrointestinal malignancies;
PeptiDream, to incorporate biologically active targeting ligands; and
Affilogic, to secure access to biologically active immuno-oncology related targeting ligands.
"We have an opportunity to formulate ACCURINS with oligonucleotides or potent kinase inhibitors while functionalizing the surface of our particles with a variety of biologically active targeting ligands," said Jonathan Yingling, Ph.D., chief scientific officer for BIND. "This has the potential to create ACCURINS that act as combination therapy within a single particle."
BIND-014
The Company released data from multiple phase 2 trials of BIND-014, ACCRUINS formulated with the approved cytotoxic cancer agent docetaxel. The iNSITE 1 trial is squamous histology non-small cell lung cancer exceeded the protocol defined endpoint of greater than 65 percent 6-week disease control rate. The data suggest BIND-014 continues to provide meaningful improvements in safety and tolerability, and at least similar efficacy in comparison to historical studies with docetaxel. As a result, BIND believes the new data further validate the ACCURINS platform and justify further development where improved safety and tolerability may be valuable. The company is seeking a collaborator to fund further development of BIND-014.
AZD2811
In collaboration with AstraZeneca, BIND developed AZD2811, which became the first nanoparticle containing a kinase inhibitor to begin clinical testing. The kinase inhibitor targets the Aurora B protein, which can contribute to the growth of tumor cells, and is currently in a phase 1 clinical trial. In the first quarter, preclinical data for AZD2811 was published in The Journal of Science Translational Medicine. The data highlighted the ability of ACCURINS to control release kinetics and provide increased concentration of nanoparticles to tumor sites.
Anticipated upcoming milestones and activities include:
Report initial in vivo POC data for discovery programs, with preclinical pharmacokinetic and efficacy data expected in second half of 2017
In vivo POC data for targeting guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies
In vivo POC data for anti-tumor immunity targeted ACCURINS
Additional in vivo POC data for delivering single and double stranded RNA fragments and achieving target knock-down in tumor models
Demonstrate in vitro and in vivo POC for achieving endosomal escape with double stranded RNA
Expand pre-clinical pharmacology for KSP ACCURINS (BIND-267), including combinations with immune-oncology biologics
Additional rodent and potentially non-rodent safety evaluation of BIND-267
Identify first ACCURINS-based immuno-oncology product concept
Identify development and commercialization partner for BIND-014
Continue to support AstraZeneca’s clinical trial activities for AZD2811
Advance the Pfizer compound toward the clinic by initiating IND-enabling studies
Key Business Developments
Implemented a restructuring plan designed to streamline operations and reduce the Company’s operating expenses
Announced shift in R&D strategy to leverage the platform to develop innovative medicines and initiate a review of financial and strategic alternatives
Initiated voluntary Chapter 11 bankruptcy protection proceedings to provide for an orderly process and additional time to pursue the strategic and financial alternatives that were previously underway
First Quarter 2016 Financial Results
Cash, cash equivalents and short-term investments were approximately $21.5 million as of March 31, 2016. Given the fact that the Company is operating under Chapter 11 bankruptcy protection, the Company is suspending financial runway guidance until further notice.
Development revenue for the first quarter of 2016 was $1.9 million, compared to $4.4 million for the first quarter of 2015. The decline was primarily due to lower reimbursed collaboration expenses related to clinical trial manufacturing activities for AZD2811, which were performed in the first quarter of 2015 to support initial clinical testing as part of the Company’s collaboration with AstraZeneca.
Research and development expenses totaled $11.2 million for the first quarter of 2016, compared to $8.2 million for the first quarter of 2015. The increase was primarily related to BIND-014 expenses of approximately $7.2 million. In addition, there was an increase in manufacturing costs related to an engineering manufacturing run of ACCURINS completed at the 15kg scale at our contract manufacturer in Germany.
General and administrative expenses totaled $3.6 million for the first quarter of 2016, compared to $4.8 million for the first quarter of 2015. The decline was partially due to one-time severance and stock-based compensation charges for our former chief executive officer in the first quarter of 2015 as well as a decrease in general consulting expenses of $0.4 million.
Net loss for the first quarter of 2016 was $12.7 million, compared to a net loss of $8.3 million for the first quarter of 2015. The increase in net loss was mostly the result of the aforementioned increase in clinical trial activities and the decrease in collaboration revenue during the first quarter of 2016.