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): July 6, 2016
ACELRX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE |
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001-35068 |
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41-2193603 |
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(State of incorporation) |
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(Commission File No.) |
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(IRS Employer Identification No.) |
351 Galveston Drive
Redwood City, CA 94063
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (650) 216-3500
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 (see General Instruction A.2. below):
☐ 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 7.01. Regulation FD Disclosure.
AcelRx Pharmaceuticals, Inc. (the “Company” or “AcelRx”) will participate in various meetings with securities analysts and investors during the Cantor Fitzgerald 2nd Annual Healthcare Conference on July 12, 2016 and will utilize a presentation handout during those meetings. The presentation handout, together with a slide setting forth certain cautionary language intended to qualify the forward-looking statements included in the presentation handout, are furnished as Exhibit 99.1 to this Current Report and are incorporated herein by reference. The presentation handout will also be made available in the “Investor Relations” section of AcelRx Pharmaceuticals, Inc.’s website, located at www.acelrx.com.
On July 6, 2016, the start date for the IAP312 study was revised to September 2016 on clintrials.gov. The Company has finalized certain modifications to the Zalviso device and pending receipt of the devices from the manufacturer, the Company intends to initiate the IAP312 study in September 2016. The start date for the study may be delayed if the devices received from the manufacturer do not pass final quality checks and certain release specifications.
The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 to this Current Report shall be deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act. The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 to this Current Report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission under the Securities Act or the Exchange Act made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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Item 9.01. |
Financial Statements and Exhibits. | |
(d) Exhibits.
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Exhibit Number |
Description | |
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99.1 |
Slide presentation entitled, “AcelRx Pharmaceuticals Corporate Presentation July 2016” | |
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.
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Date: July 7, 2016 |
ACELRX PHARMACEUTICALS, INC. |
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By: |
/s/ Jane Wright-Mitchell |
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Jane Wright-Mitchell |
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Chief Legal Officer |
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INDEX TO EXHIBITS
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Exhibit |
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Description |
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99.1 |
Slide presentation entitled, “AcelRx Pharmaceuticals Corporate Presentation July 2016” | |