UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): March 16, 2015
BIODEL INC.
(Exact name of registrant as specified in its charter)
Commission File Number 001-33451
| Delaware | 90-0136863 |
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification Number) |
| 100 Saw Mill Road | |
| Danbury, Connecticut | 06810 |
| (Address of principal executive offices) | (Zip code) |
(203) 796-5000
(Registrant's telephone number, including area code)
| Not Applicable |
| (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 7.01Regulation FD Disclosure.
Biodel Inc. (the “Company”) has attached hereto as Exhibit 99.1 a slide presentation, which it intends to present and/or distribute to the investment community beginning on March 16, 2015. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act for the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such filing.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent Biodel’s management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding Biodel’s strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Biodel’s forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including those risks and uncertainties identified in Biodel’s most recent report on Form 10-K for the fiscal year ended September 30, 2014 and other subsequent filings with the Securities and Exchange Commission.
Item 8.01Other Events.
On March 16, 2015, the Company issued a press release reporting preliminary results from a Phase 1 clinical trial of its product candidate BIOD-961, a glucagon formulation designed for use in the Company’s proposed Glucagon Emergency Management (GEM) auto-reconstitution device. The full text of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.
Item 9.01Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Slide Presentation of Biodel Inc. | ||
| 99.2 | Press Release issued by the Company on March 16, 2015. |
2
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.
| Date: March 16, 2015 | BIODEL INC. | ||
| By: | /s/ Paul S. Bavier | ||
| Paul S. Bavier, General Counsel and Secretary | |||
3
EXHIBIT INDEX
| Exhibit No. | Description | ||
| 99.1 | Slide Presentation of Biodel Inc. | ||
| 99.2 | Press Release issued by the Company on March 16, 2015. | ||
4