UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): November 18, 2015
BIND THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36072 | 56-2596148 | ||
(State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
325 Vassar Street, Cambridge, Massachusetts 02139
(Address of principal executive offices) (Zip Code)
(617) 491-3400
(Registrants telephone number, include area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
On November 18, 2015, BIND Therapeutics, Inc. (the Company) announced that AstraZeneca AB (AstraZeneca) has initiated patient dosing in a phase 1 clinical trial of AstraZenecas Accurin AZD2811, an Aurora B Kinase inhibitor, in solid tumors (the Phase 1 Trial). Under terms of the collaboration agreement between the Company and AstraZeneca, the Company earned a $4.0 million clinical milestone payment upon the first dosing of a patient in the Phase 1 Trial.
Based on the $4.0 million AstraZeneca clinical milestone payment, the previously announced $2.5 million Pfizer option exercise fee and anticipated R&D reimbursement for the next stage of the Pfizer collaboration, the Company reiterates that it expects its cash, cash equivalents and short-term investments to fund operating expense and capital expenditure requirements into the fourth quarter of 2016. This expectation is based on the Companys 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.
Forward-Looking Statements
This Current Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the sufficiency of the Companys cash, cash equivalents and short-term investments.
These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Companys actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the Company has incurred significant losses since its inception and expects to incur losses for the foreseeable future; the Companys need for additional funding, which may not be available; raising additional capital may cause dilution to its stockholders, restrict its operations or require it to relinquish rights to its technologies or drug candidates; the Companys limited operating history; the terms of the Companys credit facility place restrictions on its operating and financial flexibility; the Companys inability to utilize its net operating loss carryforwards and certain other tax attributes; failure to use and expand its medicinal nanoengineering platform to build a pipeline of drug candidates and develop marketable drugs; the early stage of the Companys development efforts with only BIND-014 and AZD2811 in clinical development; failure of the Company or its collaborators to successfully develop and commercialize drug candidates; clinical drug development involves a lengthy and expensive process, with an uncertain outcome; delays or difficulties in the enrollment of patients in clinical trials; serious adverse or unacceptable side effects or limited efficacy observed during the development of the Companys drug candidates; inability to maintain any of the Companys collaborations, or the failure of these collaborations; the Companys reliance on third parties to conduct its clinical trials and manufacture its drug candidates; the Companys inability to obtain required regulatory approvals; any conclusion by the FDA that BIND-014 does not satisfy the requirements for approval under the Section 505(b)(2) regulatory approval pathway; the fact that a fast track or breakthrough therapy designation by the FDA for the Companys drug candidates may not actually lead to a faster development or regulatory review or approval process; the inability to obtain orphan drug exclusivity for drug candidates; failure to obtain marketing approval in international jurisdictions; any post-marketing restrictions or withdrawals from the market; failure to comply with anti-kickback, fraud and abuse and other healthcare laws and regulations; effects of recently enacted and future legislation; effects of strict price controls imposed by governments outside the United States; failure to comply with environmental, health and safety laws and regulations; failure to achieve market acceptance by physicians, patients, or third-party payors; failure to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties with such capabilities; effects of substantial competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to retain key executives and attract, retain and motivate qualified personnel; difficulties in managing the Companys growth; risks associated with operating internationally, including the possibility of sanctions with respect to our operations in Russia; the possibility of system failures or security breaches; failure to obtain and maintain patent protection for or otherwise protect our technology and products; effects of patent or other intellectual property lawsuits; the volatility of the price of the Companys common stock, which could result in substantial losses for its stockholders; significant costs and required management time as a result of operating as a public company; and any securities class action litigation. These and other important factors discussed under the caption Risk Factors in the Companys Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 2, 2015, and the Companys other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this Current Report. Any such forward-looking statements represent managements estimates as of the date of this Current Report. While the Company may elect to update such forward-looking statements at some point in the future, the
Company disclaims any obligation to do so, even if subsequent events cause the Companys views to change. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date of this Current Report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
BIND THERAPEUTICS, INC. | ||||||
Date: November 18, 2015 | By: | /s/ Andrew Hirsch | ||||
Andrew Hirsch | ||||||
President and Chief Executive Officer |