Biodel Inc. News
Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results
"We remain on track in our development of VIAject(TM)," stated Dr.
Three Months Ended
Biodel reported no revenue during the three months ended
Biodel reported a net loss for the three months ended
Research and development expenses were
General and administrative expenses totaled
Six Months Ended
Biodel reported no revenue during the six months ended
Biodel reported a net loss for the six months ended
Research and development expenses were
General and administrative expenses totaled
At the end of the second quarter 2008, Biodel had cash and cash equivalents of
Second Quarter Fiscal Year 2008 Corporate Highlights — The Company is continuing the clinical development of its lead product candidate, VIAject(TM), an ultra rapid-acting injectable meal-time insulin for use by patients with Type 1 or Type 2 diabetes. VIAject(TM) is currently being tested in two pivotal Phase III clinical trials. Enrollment for both Phase III studies was completed in December 2007 and the last patient visit is expected in July 2008. The Company expects to announce top line data late in the third or early in the fourth calendar quarter of 2008 and to submit a New Drug Application to the FDA for the complete suite of VIAject(TM) products by the end of 2008. — On February 12, 2008, the Company completed a follow-on public offering of 3,260,000 shares of its common stock at a price to the public of $15.50 per share. The Company received net proceeds from this offering, after deducting underwriting discounts and commissions and expenses, of $46.8 million. The Company intends to use the net proceeds that it received from this offering to fund the continued development and commercialization of VIAject(TM), to develop its other product candidates and for working capital, additional capital expenditures and other general corporate purposes.
Conference Call and Webcast Information
Biodel's senior management will host a conference call on
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed by using VIAdel(TM) technology, which reformulates existing FDA- approved peptide drugs. The Company's lead product candidate, VIAject(TM), is an ultra rapid-acting injectable meal-time insulin in development for use by patients with Type 1 or Type 2 diabetes. VIAject(TM) is currently being tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM), a sublingual tablet formulation of insulin in the Phase I stage of clinical testing, and two pre-clinical osteoporosis product candidates. For further information regarding Biodel, please visit the Company's website at www.biodel.com.
Safe Harbor
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, including statements regarding our 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. The Company'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, but not limited to, our ability to secure FDA approval for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product candidates, particularly VIAject(TM) and VIAtab(TM); our ability to secure additional patents for VIAject(TM) and our other product candidates; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our Quarterly Report on Form 10-Q for the quarter ended
BIOD-G Biodel Inc. (A Development Stage Company) Condensed Balance Sheets (in thousands, except share and per share amounts) September 30, March 31, 2007 2008 (unaudited) ASSETS Current: Cash and cash equivalents $80,022 $107,884 Marketable securities - 3,803 Prepaid and other assets 505 206 Total current assets 80,527 111,893 Property and equipment, net 1,717 3,357 Intellectual property, net 262 285 Total assets $82,506 $115,535 LIABILITIES AND STOCKHOLDERS' EQUITY Current: Accounts payable $2,187 $2,876 Accrued expenses: Clinical trial expenses 1,164 1,560 Payroll and related 822 780 Accounting and legal fees 335 364 Severance expense - 355 Other 680 617 Taxes payable 95 170 Total current liabilities 5,283 6,722 Other long term liabilities - 141 Stockholders' equity: Preferred stock, $0.01 par value; 50,000,000 shares authorized - - Common stock, $0.01 par value; 100,000,000 shares authorized; 20,160,836 and 23,611,346 shares issued and outstanding, respectively 202 236 Additional paid-in capital 116,854 168,853 Deficit accumulated during the development stage (39,833) (60,417) Total stockholders' equity 77,223 108,672 Total liabilities and stockholders' equity $82,506 $115,535 Biodel Inc. (A Development Stage Company) Condensed Statements of Operations (in thousands, except share and per share amounts) (unaudited) December 3, 2003 (inception) Three Months Ended Six Months Ended to March 31, March 31, March 31, 2007 2008 2007 2008 2008 Revenue $- $- $- $- $- Operating expenses: Research and development 3,815 7,105 6,330 14,650 39,822 General and administrative 1,504 3,532 2,825 7,664 18,515 Total operating expenses 5,319 10,637 9,155 22,314 58,337 Other (income) and expense: Interest and other income (132) (1,111) (322) (1,783) (3,876) Interest expense - - - - 78 Loss on settlement of debt - - - - 627 Operating loss before tax provision (5,187) (9,526) (8,833) (20,531) (55,166) Tax provision 28 31 46 53 191 Net loss (5,215) (9,557) (8,879) (20,584) (55,357) Charge for accretion of beneficial conversion rights - - - - (603) Deemed dividend - warrants (4,457) - (4,457) - (4,457) Net loss applicable to common stockholders $(9,672) $(9,557) $(13,336) $(20,584) $(60,417) Net loss per share - basic and diluted $(1.79) $(0.43) $(2.48) $(0.97) Weighted average shares outstanding - basic and diluted 5,396,220 22,045,400 5,369,136 21,116,654
SOURCE Biodel Inc.
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