Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Dec. 31, 2013 | Jan. 31, 2014 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'Biodel Inc | ' |
Entity Central Index Key | '0001322505 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--09-30 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 31-Dec-13 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q1 | ' |
Entity Filer Category | 'Smaller Reporting Company | ' |
Entity Common Stock, Shares Outstanding | ' | 21,075,870 |
Consolidated_Condensed_Balance
Consolidated Condensed Balance Sheets (USD $) | Dec. 31, 2013 | Sep. 30, 2013 |
In Thousands, unless otherwise specified | ||
Current: | ' | ' |
Cash and cash equivalents | $35,241 | $39,781 |
Taxes receivable | 6 | 6 |
Grant receivable | 97 | 26 |
Prepaid and other assets | 725 | 264 |
Total current assets | 36,069 | 40,077 |
Property and equipment, net | 883 | 1,031 |
Intellectual property, net | 42 | 43 |
Total assets | 36,994 | 41,151 |
Current: | ' | ' |
Accounts payable | 1,788 | 246 |
Accrued expenses: | ' | ' |
Clinical trial expenses | 257 | 181 |
Payroll and related | 491 | 1,139 |
Accounting and legal fees | 160 | 226 |
Severance | 162 | 255 |
Other | 173 | 319 |
Income taxes payable | 3 | 75 |
Total current liabilities | 3,034 | 2,441 |
Common stock warrant liability | 3,535 | 6,121 |
Other long term liabilities | ' | 26 |
Total liabilities | 6,569 | 8,588 |
Commitments | ' | ' |
Stockholders' equity: | ' | ' |
Convertible Preferred stock, $.01 par value; 50,000,000 shares authorized, 1,950,000 and 1,950,000 issued and outstanding | 19 | 19 |
Common stock, $.01 par value; 62,500,000 shares authorized; 21,070,824 and 21,075,870 issued and outstanding | 211 | 211 |
Additional paid-in capital | 248,066 | 247,761 |
Deficit accumulated during the development stage | -217,871 | -215,428 |
Total stockholders' equity | 30,425 | 32,563 |
Total liabilities and stockholders' equity | $36,994 | $41,151 |
Consolidated_Condensed_Balance1
Consolidated Condensed Balance Sheets (Parenthetical) (USD $) | Dec. 31, 2013 | Sep. 30, 2013 |
Balance Sheets [Abstract] | ' | ' |
Preferred stock, par value (in dollars per share) | $0.01 | $0.01 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 1,950,000 | 1,950,000 |
Preferred stock, shares outstanding | 1,950,000 | 1,950,000 |
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 62,500,000 | 62,500,000 |
Common stock, shares issued | 21,075,870 | 21,070,824 |
Common stock, shares outstanding | 21,075,870 | 21,070,824 |
Consolidated_Condensed_Stateme
Consolidated Condensed Statements of Operations (USD $) | 3 Months Ended | 121 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 |
Income Statement [Abstract] | ' | ' | ' |
Revenue | ' | ' | ' |
Operating expenses: | ' | ' | ' |
Research and development | 3,741 | 4,676 | 159,141 |
Government grant | -97 | -196 | -731 |
General and administrative | 1,396 | 1,429 | 73,597 |
Total operating expenses | 5,040 | 5,909 | 232,007 |
Other (income) and expense: | ' | ' | ' |
Interest and other income | -16 | -16 | -5,718 |
Interest expense | ' | ' | 78 |
Adjustment to fair value of common stock warrant liability | -2,586 | -2,228 | -13,650 |
Loss on settlement of debt | ' | ' | 627 |
Loss before tax provision (benefit) | -2,438 | -3,665 | -213,344 |
Tax provision (benefit) | 5 | 4 | -533 |
Net loss | -2,443 | -3,669 | -212,811 |
Charge for accretion of beneficial conversion rights | ' | ' | -603 |
Deemed dividend - warrants | ' | ' | -4,457 |
Net loss applicable to common stockholders | ($2,443) | ($3,669) | ($217,871) |
Net loss per share - basic and diluted | ($0.12) | ($0.26) | ' |
Weighted average shares outstanding - basic and diluted | 21,073,676 | 14,176,057 | ' |
Consolidated_Condensed_Stateme1
Consolidated Condensed Statements of Stockholders' Equity (USD $) | Total | Common Stock $.01 Par Value | Series A Preferred stock | Series B Preferred stock | Additional Paid in Capital | Accumulated Other Comprehensive Income (loss) | Accumulated Deficit during the Development Stage |
In Thousands, except Share data | |||||||
Balance at Dec. 03, 2003 | ' | ' | ' | ' | ' | ' | ' |
Balance (in shares) at Dec. 03, 2003 | ' | ' | ' | ' | ' | ' | ' |
Shares issued to employees and directors for services | ' | 2 | ' | ' | -2 | ' | ' |
Shares issued to employees and directors for services (in shares) | ' | 831,126 | ' | ' | ' | ' | ' |
Proceeds from sale of common stock | 1,354 | 11 | ' | ' | 1,343 | ' | ' |
Proceeds from sale of common stock (in shares) | ' | 1,145,306 | ' | ' | ' | ' | ' |
Net loss | -774 | ' | ' | ' | ' | ' | -774 |
Balance at Sep. 30, 2004 | 580 | 13 | ' | ' | 1,341 | ' | -774 |
Balance (in shares) at Sep. 30, 2004 | ' | 1,328,432 | ' | ' | ' | ' | ' |
Shares issued to employees and directors for services | 61 | ' | ' | ' | 61 | ' | ' |
Shares issued to employees and directors for services (in shares) | ' | 10,658 | ' | ' | ' | ' | ' |
Additional stockholder contributions | 514 | ' | ' | ' | 514 | ' | ' |
Stock-based compensation | 353 | ' | ' | ' | 353 | ' | ' |
Private placement - Sale of preferred stock, net of issuance costs of $379 (July 2005) (Series A) and $1,795 (July 2006) (Series B) for 2005 and 2006 respectively | 2,466 | ' | 6 | ' | 2,460 | ' | ' |
Private placement - Sale of preferred stock, net of issuance costs of $379 (July 2005) (Series A) and $1,795 (July 2006) (Series B) for 2005 and 2006 respectively (in shares) | ' | ' | 569,000 | ' | ' | ' | ' |
Founder's compensation contributed to capital | 63 | ' | ' | ' | 63 | ' | ' |
Net loss | -3,383 | ' | ' | ' | ' | ' | -3,383 |
Balance at Sep. 30, 2005 | 654 | 13 | 6 | ' | 4,792 | ' | -4,157 |
Balance (in shares) at Sep. 30, 2005 | ' | 1,339,090 | 569,000 | ' | ' | ' | ' |
Shares issued to employees and directors for services | 23 | ' | ' | ' | 23 | ' | ' |
Shares issued to employees and directors for services (in shares) | ' | 988 | ' | ' | ' | ' | ' |
Stock-based compensation | 1,132 | ' | ' | ' | 1,132 | ' | ' |
Private placement - Sale of preferred stock, net of issuance costs of $379 (July 2005) (Series A) and $1,795 (July 2006) (Series B) for 2005 and 2006 respectively | 19,405 | ' | ' | 54 | 19,351 | ' | ' |
Private placement - Sale of preferred stock, net of issuance costs of $379 (July 2005) (Series A) and $1,795 (July 2006) (Series B) for 2005 and 2006 respectively (in shares) | ' | ' | ' | 5,380,711 | ' | ' | ' |
July 2006 - Series B preferred stock units issued July 2006 to settle debt | 3,202 | ' | ' | 8 | 3,194 | ' | ' |
July 2006 - Series B preferred stock units issued July 2006 to settle debt (in shares) | ' | ' | ' | 817,468 | ' | ' | ' |
Accretion of fair value of beneficial conversion charge | ' | ' | ' | ' | 603 | ' | -603 |
Net loss | -8,068 | ' | ' | ' | ' | ' | -8,068 |
Balance at Sep. 30, 2006 | 16,348 | 13 | 6 | 62 | 29,095 | ' | -12,828 |
Balance (in shares) at Sep. 30, 2006 | ' | 1,340,078 | 569,000 | 6,198,179 | ' | ' | ' |
Stock-based compensation | 4,224 | ' | ' | ' | 4,224 | ' | ' |
Proceeds from sale of common stock | 78,755 | 14 | ' | ' | 78,741 | ' | ' |
Proceeds from sale of common stock (in shares) | ' | 1,437,500 | ' | ' | ' | ' | ' |
Conversion of preferred stock | ' | 16 | -6 | -62 | 52 | ' | ' |
Conversion of preferred stock (in shares) | ' | 1,601,749 | -569,000 | -6,198,179 | ' | ' | ' |
Shares issued to employees, non-employees and directors for services | 16 | ' | ' | ' | 16 | ' | ' |
Shares issued to employees, non-employees and directors for services (in shares) | ' | 732 | ' | ' | ' | ' | ' |
Stock options exercised | 5 | ' | ' | ' | 5 | ' | ' |
Stock options exercised (in shares) | ' | 885 | ' | ' | ' | ' | ' |
Warrants exercised | 423 | 7 | ' | ' | 416 | ' | ' |
Warrants exercised (in shares) | ' | 659,226 | ' | ' | ' | ' | ' |
Deemed dividend - warrants | ' | ' | ' | ' | 4,457 | ' | -4,457 |
Net loss | -22,548 | ' | ' | ' | ' | ' | -22,548 |
Balance at Sep. 30, 2007 | 77,223 | 50 | ' | ' | 117,006 | ' | -39,833 |
Balance (in shares) at Sep. 30, 2007 | ' | 5,040,170 | ' | ' | ' | ' | ' |
Stock-based compensation | 6,503 | ' | ' | ' | 6,503 | ' | ' |
Proceeds from sale of common stock | 46,817 | 8 | ' | ' | 46,809 | ' | ' |
Proceeds from sale of common stock (in shares) | ' | 815,000 | ' | ' | ' | ' | ' |
Stock options exercised | 902 | 1 | ' | ' | 901 | ' | ' |
Stock options exercised (in shares) | ' | 43,600 | ' | ' | ' | ' | ' |
Warrants exercised | 112 | ' | ' | ' | 112 | ' | ' |
Warrants exercised (in shares) | ' | 19,802 | ' | ' | ' | ' | ' |
Proceeds from the sale of stock - ESPP | 181 | ' | ' | ' | 181 | ' | ' |
Proceeds from the sale of stock - ESPP (in shares) | ' | 3,596 | ' | ' | ' | ' | ' |
RSUs granted | 172 | ' | ' | ' | 172 | ' | ' |
RSUs granted (in shares) | ' | 2,428 | ' | ' | ' | ' | ' |
Net unrealized gain (loss) on Marketable Securities | -62 | ' | ' | ' | ' | -62 | ' |
Net loss | -43,361 | ' | ' | ' | ' | ' | -43,361 |
Balance at Sep. 30, 2008 | 88,487 | 59 | ' | ' | 171,684 | -62 | -83,194 |
Balance (in shares) at Sep. 30, 2008 | ' | 5,924,596 | ' | ' | ' | ' | ' |
Stock-based compensation | 5,064 | ' | ' | ' | 5,064 | ' | ' |
Stock options exercised | 25 | ' | ' | ' | 25 | ' | ' |
Stock options exercised (in shares) | ' | 4,413 | ' | ' | ' | ' | ' |
Proceeds from the sale of stock - ESPP | 170 | ' | ' | ' | 170 | ' | ' |
Proceeds from the sale of stock - ESPP (in shares) | ' | 21,863 | ' | ' | ' | ' | ' |
Net unrealized gain (loss) on Marketable Securities | 62 | ' | ' | ' | ' | 62 | ' |
Net loss | -43,270 | ' | ' | ' | ' | ' | -43,270 |
Balance at Sep. 30, 2009 | 50,538 | 59 | ' | ' | 176,943 | ' | -126,464 |
Balance (in shares) at Sep. 30, 2009 | ' | 5,950,872 | ' | ' | ' | ' | ' |
Stock-based compensation | 5,621 | ' | ' | ' | 5,621 | ' | ' |
Registered direct offering or financing | 8,712 | 6 | ' | ' | 8,706 | ' | ' |
Registered direct offering or financing (in shares) | ' | 599,550 | ' | ' | ' | ' | ' |
Initial value of warrants issued in registered direct offering | -2,915 | ' | ' | ' | -2,915 | ' | ' |
Stock options exercised | 68 | ' | ' | ' | 68 | ' | ' |
Stock options exercised (in shares) | ' | 8,076 | ' | ' | ' | ' | ' |
Proceeds from the sale of stock - ESPP | 325 | 1 | ' | ' | 324 | ' | ' |
Proceeds from the sale of stock - ESPP (in shares) | ' | 41,393 | ' | ' | ' | ' | ' |
Net unrealized gain (loss) on Marketable Securities | 1 | ' | ' | ' | ' | 1 | ' |
Net loss | -38,290 | ' | ' | ' | ' | ' | -38,290 |
Balance at Sep. 30, 2010 | 24,060 | 66 | ' | ' | 188,747 | 1 | -164,754 |
Balance (in shares) at Sep. 30, 2010 | ' | 6,599,891 | ' | ' | ' | ' | ' |
Stock-based compensation | 4,920 | ' | ' | ' | 4,920 | ' | ' |
Registered direct offering or financing | 27,961 | 30 | 18 | ' | 27,913 | ' | ' |
Registered direct offering or financing (in shares) | ' | 3,018,736 | 1,813,944 | ' | ' | ' | ' |
Initial value of warrants issued in registered direct offering | -9,438 | ' | ' | ' | -9,438 | ' | ' |
Stock options exercised (in shares) | ' | 104 | ' | ' | ' | ' | ' |
Warrants exercised | 50 | ' | ' | ' | 50 | ' | ' |
Warrants exercised (in shares) | ' | 10,549 | ' | ' | ' | ' | ' |
Proceeds from the sale of stock - ESPP | 118 | ' | ' | ' | 118 | ' | ' |
Proceeds from the sale of stock - ESPP (in shares) | ' | 17,051 | ' | ' | ' | ' | ' |
RSUs granted (in shares) | ' | 15,537 | ' | ' | ' | ' | ' |
Net unrealized gain (loss) on Marketable Securities | -1 | ' | ' | ' | ' | -1 | ' |
Net loss | -10,592 | ' | ' | ' | ' | ' | -10,592 |
Balance at Sep. 30, 2011 | 37,078 | 96 | 18 | ' | 212,310 | ' | -175,346 |
Balance (in shares) at Sep. 30, 2011 | ' | 9,661,868 | 1,813,944 | ' | ' | ' | ' |
Proceeds from the sale of unregistered securities | 17,078 | 43 | ' | 36 | 16,999 | ' | ' |
Proceeds from the sale of unregistered securities, shares | ' | 4,250,020 | ' | 3,605,607 | ' | ' | ' |
Initial value of warrants issued in private placement financing | -4,832 | ' | ' | ' | -4,832 | ' | ' |
Stock-based compensation | 1,828 | ' | ' | ' | 1,828 | ' | ' |
Proceeds from the sale of stock - ESPP | 27 | ' | ' | ' | 27 | ' | ' |
Proceeds from the sale of stock - ESPP (in shares) | ' | 10,776 | ' | ' | ' | ' | ' |
RSUs issued to settle bonus liability | 584 | 2 | ' | ' | 582 | ' | ' |
RSUs issued to settle bonus liability, (in shares) | ' | 191,719 | ' | ' | ' | ' | ' |
RSUs granted | ' | 1 | ' | ' | -1 | ' | ' |
RSUs granted (in shares) | ' | 60,409 | ' | ' | ' | ' | ' |
Net loss | -20,747 | ' | ' | ' | ' | ' | -20,747 |
Company re-purchase of fractional shares from the reverse stock split | ' | -247 | ' | ' | ' | ' | ' |
Balance at Sep. 30, 2012 | 31,016 | 142 | 18 | 36 | 226,913 | ' | -196,093 |
Balance (in shares) at Sep. 30, 2012 | ' | 14,174,545 | 1,813,944 | 3,605,607 | ' | ' | ' |
Stock-based compensation | 1,538 | ' | ' | ' | 1,538 | ' | ' |
Proceeds from sale of common stock | 19,239 | 47 | ' | ' | 19,192 | ' | ' |
Proceeds from sale of common stock (in shares) | ' | 4,718,767 | ' | ' | ' | ' | ' |
Conversion of preferred stock | ' | 22 | -18 | -17 | 13 | ' | ' |
Conversion of preferred stock (in shares) | ' | 2,109,090 | -1,813,944 | -1,655,607 | ' | ' | ' |
Stock options exercised | 75 | ' | ' | ' | 75 | ' | ' |
Stock options exercised (in shares) | ' | 30,250 | ' | ' | ' | ' | ' |
Proceeds from the sale of stock - ESPP | 30 | ' | ' | ' | 30 | ' | ' |
Proceeds from the sale of stock - ESPP (in shares) | ' | 13,395 | ' | ' | ' | ' | ' |
RSUs granted (in shares) | ' | 24,777 | ' | ' | ' | ' | ' |
Net loss | -19,335 | ' | ' | ' | ' | ' | -19,335 |
Balance at Sep. 30, 2013 | 32,563 | 211 | ' | 19 | 247,761 | ' | -215,428 |
Balance (in shares) at Sep. 30, 2013 | ' | 21,070,824 | ' | 1,950,000 | ' | ' | ' |
Stock-based compensation | 295 | ' | ' | ' | 295 | ' | ' |
Proceeds from the sale of stock - ESPP | 10 | ' | ' | ' | 10 | ' | ' |
Proceeds from the sale of stock - ESPP (in shares) | ' | 5,046 | ' | ' | ' | ' | ' |
Net loss | -2,443 | ' | ' | ' | ' | ' | -2,443 |
Balance at Dec. 31, 2013 | $30,425 | $211 | ' | $19 | $248,066 | ' | ($217,871) |
Balance (in shares) at Dec. 31, 2013 | ' | 21,075,870 | ' | 1,950,000 | ' | ' | ' |
Consolidated_Condensed_Stateme2
Consolidated Condensed Statements of Stockholders' Equity (Parenthetical) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2005 | Sep. 30, 2006 |
Series A Preferred stock | Series B Preferred stock | |
Issuance costs of Preferred Stock, Private Placement (in dollars) | $379 | $1,795 |
Consolidated_Condensed_Stateme3
Consolidated Condensed Statements of Cash Flows (USD $) | 3 Months Ended | 121 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 |
Cash flows from operating activities: | ' | ' | ' |
Net loss | ($2,443) | ($3,669) | ($212,811) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization | 156 | 167 | 5,600 |
Founder's compensation contributed to capital | ' | ' | 271 |
Stock-based compensation for employees and directors | 295 | 545 | 29,457 |
Stock-based compensation for non-employees | ' | ' | 2,274 |
Loss on settlement of debt | ' | ' | 627 |
Write-off of capitalized patent expense | ' | ' | 246 |
Write-off of loan to related party | ' | ' | 41 |
Adjustment to fair value of common stock warrant liability | -2,586 | -2,228 | -13,650 |
(Increase) decrease in: | ' | ' | ' |
Income taxes receivable | ' | ' | -6 |
Grant receivable | -71 | -196 | -96 |
Other receivables | ' | 9 | -1 |
Prepaid expenses and other assets | -461 | -821 | -725 |
Increase (decrease) in: | ' | ' | ' |
Accounts payable | 1,542 | 844 | 1,788 |
Income taxes payable | -72 | -8 | 3 |
Accrued expenses and long term liabilities | -904 | 666 | 2,048 |
Total adjustments | -2,101 | -1,022 | 27,877 |
Net cash used in operating activities | -4,544 | -4,691 | -184,934 |
Cash flows from investing activities: | ' | ' | ' |
Purchase of property and equipment | -6 | -87 | -6,473 |
Purchase of marketable securities | ' | ' | -31,614 |
Sale of marketable securities | ' | ' | 31,614 |
Capitalized intellectual properties | ' | ' | -298 |
Loan to related party | ' | ' | -41 |
Net cash used in investing activities | -6 | -87 | -6,812 |
Cash flows from financing activities: | ' | ' | ' |
Options exercised | ' | ' | 1,075 |
Warrants exercised | ' | ' | 585 |
Net proceeds from employee stock purchase plan | 10 | 6 | 861 |
Deferred public offering costs | ' | ' | -1,458 |
Stockholder contribution | ' | ' | 1,660 |
Net proceeds from sale of preferred stock | ' | ' | ' |
Net proceeds from sale of unregistered common stock - private placement | ' | ' | 8,585 |
Net proceeds from sale of common stock | ' | ' | 180,257 |
Proceeds from bridge financing | ' | ' | 2,575 |
Net cash provided by financing activities | 10 | 6 | 226,987 |
Net increase (decrease) in cash and cash equivalents | -4,540 | -4,772 | 35,241 |
Cash and cash equivalents, beginning of period | 39,781 | 39,050 | ' |
Cash and cash equivalents, end of period | 35,241 | 34,278 | 35,241 |
Cash paid for interest and income taxes was: | ' | ' | ' |
Interest | ' | ' | 9 |
Income taxes | 2 | 12 | 340 |
Non-cash financing and investing activities: | ' | ' | ' |
Warrants issued in connection with registered direct offering | ' | ' | 12,353 |
Warrants issued in connection with unregistered common stock - private placement | ' | ' | 4,832 |
Settlement of debt with Series B preferred stock | ' | ' | 3,202 |
Accrued expenses settled with Series B preferred stock | ' | ' | 150 |
Deemed dividend - warrants | ' | ' | 4,457 |
Accretion of fair value of beneficial charge on preferred stock | ' | ' | 603 |
Conversion of convertible preferred stock to common stock | ' | ' | 68 |
Issuance of restricted stock units to settle accrued bonus | ' | ' | 584 |
Series A preferred stock 2005 | ' | ' | ' |
Cash flows from financing activities: | ' | ' | ' |
Net proceeds from sale of preferred stock | ' | ' | 2,466 |
Series A preferred stock 2011 | ' | ' | ' |
Cash flows from financing activities: | ' | ' | ' |
Net proceeds from sale of preferred stock | ' | ' | 2,685 |
Series B preferred stock 2006 | ' | ' | ' |
Cash flows from financing activities: | ' | ' | ' |
Net proceeds from sale of preferred stock | ' | ' | 19,205 |
Series B preferred stock 2012 | ' | ' | ' |
Cash flows from financing activities: | ' | ' | ' |
Net proceeds from sale of preferred stock | ' | ' | $8,491 |
Business_and_Basis_of_Presenta
Business and Basis of Presentation | 3 Months Ended |
Dec. 31, 2013 | |
Business and Basis of Presentation [Abstract] | ' |
Business and Basis of Presentation | ' |
1. Business and Basis of Presentation | |
Business | |
Biodel Inc. and its wholly owned subsidiary (collectively, “Biodel” or the “Company”, and formerly Global Positioning Group Ltd.) is a development stage specialty pharmaceutical company located in Danbury, Connecticut. The Company was incorporated in the State of Delaware on December 3, 2003 and commenced operations in January 2004. The Company formed a wholly owned subsidiary in the United Kingdom in October 2011 (“Biodel UK Limited”). This subsidiary has been inactive since its inception. The Company focuses on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. | |
The Company is developing room temperature stable glucagon presentations for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. The leading presentation uses a proprietary device from Unilife Corporation. The device, which is being customized for use in emergency situations, is a dual-chamber design that automatically reconstitutes lyophilized glucagon with a liquid diluent immediately prior to injection, and it features automatic needle retraction on full dose delivery. The Company expects to submit an Investigational New Drug application to the FDA for its dual-chamber glucagon rescue product in the second half of calendar year 2014 and initiate a pivotal clinical trial in the fourth calendar quarter of 2014. The Company has entered into a customization and commercial supply agreement with Unilife Medical Solutions, Inc., a wholly owned subsidiary of Unilife Corporation, to acquire an exclusive, sublicensable, worldwide license to the dual-chamber device for use with glucagon. The Company has also entered into a long-term commercial supply agreement with Becton, Dickinson and Company for worldwide exclusive rights to its Uniject disposable injection system for use with liquid glucagon formulations. The Company is currently assessing several formulations of liquid glucagon in pre-clinical studies. | |
The Company is also developing proprietary insulin formulations that are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. The Company refers to these as “ultra-rapid-acting” formulations. The Company’s most advanced ultra-rapid-acting insulin formulation, BIOD-123, combines recombinant human insulin, or RHI, with the Company’s proprietary combination of excipients to increase the rate of absorption following subcutaneous injection when compared to other commercially available insulin formulations, including “rapid-acting” mealtime insulin analogs such as Humalog®, marketed by Eli Lilly, NovoLog®, marketed by Novo Nordisk, and Apidra®, marketed by Sanofi. The Company is also using its proprietary excipients to develop ultra-rapid-acting insulin analog-based formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog®, or insulin aspart, the active pharmaceutical ingredient in NovoLog®. | |
In addition to BIOD-123, the Company has other RHI-based formulations in earlier stages of development. In particular, it is developing ultra-rapid-acting formulations of concentrated insulin that are characterized in pre-clinical studies with diabetic swine by a rapid onset of action and a prolonged duration of action, which may be superior to that of existing concentrated insulins and prandial/basal pre-mixed insulins. In the fourth calendar quarter of 2013, the Company initiated a Phase 1 clinical trial with BIOD-531, its lead candidate for an ultra-rapid-acting concentrated insulin formulation. | |
Basis of Presentation | |
The consolidated financial statements have been prepared by the Company and are unaudited. These consolidated financial statements include Biodel UK Limited. This subsidiary has been inactive since its inception. All intercompany balances and transactions have been eliminated. In the opinion of management, the Company has made all adjustments (consisting of normal recurring accruals) necessary to fairly present the financial position and results of operations for the interim periods presented. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) have been consolidated or omitted. These consolidated financial statements should be read in conjunction with the September 30, 2013 audited financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2013, filed with the Securities and Exchange Commission on December 20, 2013. The results of operations for the three months ended December 31, 2013 are not necessarily indicative of the operating results for the full fiscal year or any other interim period. | |
The Company is in the development stage, as defined by Financial Accounting Standards Board (“FASB”) ASC 915 (prior authoritative literature: Statement of Financial Accounting Standards No. 7), “Accounting and Reporting by Development Stage Enterprises”, as its primary activities since incorporation have been establishing its facilities, recruiting personnel, conducting research and development, business development, business and financial planning and raising capital. | |
On June 11, 2012, the Company effected a one-for-four reverse split of its outstanding common stock. All references in these financial statements and accompanying notes to units of common stock or per share amounts are reflective of the reverse split for all periods reported. (See Note 5.) |
Fair_Value_of_Financial_Instru
Fair Value of Financial Instruments | 3 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Fair Value of Financial Instruments [Abstract] | ' | ||||||||||||||||
Fair Value Measurements | ' | ||||||||||||||||
2. Fair Value of Financial Instruments | |||||||||||||||||
The carrying amounts of the Company's financial instruments, which include cash and cash equivalents, and accounts payable, approximate their fair values due to their short term maturities. | |||||||||||||||||
ASC Topic 820 ("ASC 820", originally issued as SFAS No. 157, Fair Value Measurements) applies under other accounting pronouncements that require or permit fair value measurements, the FASB having previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, ASC 820 does not require any new fair value measurements. The fair value framework requires the categorization of assets and liabilities into three levels based upon the assumptions (inputs) used to price the assets or liabilities. The three levels of inputs used are as follows: | |||||||||||||||||
Level 1 — Quoted prices in active markets for identical assets or liabilities. | |||||||||||||||||
Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. | |||||||||||||||||
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. | |||||||||||||||||
As of September 30, 2013 and December 31, 2013, the Company had assets and liabilities that fell under the scope of ASC 820. The Company used the Black-Scholes valuation model to determine the fair value of the Company's warrant liability as of September 30, 2013 and December 31, 2013 for the warrants issued in the May 2011 and June 2012 financings (as defined in Note 9). The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. Accordingly, the Company's fair value measurements of its cash and cash equivalents and restricted cash are classified as a Level 1 input and the warrant liability as a Level 3 input. | |||||||||||||||||
The fair value of the Company's financial assets and liabilities carried at fair value and measured on a recurring basis are as follows: | |||||||||||||||||
Description | Fair Value at | Quoted Prices in | Significant Other | Significant | |||||||||||||
31-Dec-13 | Active Markets for | Observable | Unobservable | ||||||||||||||
Identical Assets | Market Inputs | Inputs | |||||||||||||||
(Level 1) | (Level 2) | (Level 3) | |||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 35,241 | $ | 35,241 | $ | — | $ | — | |||||||||
Subtotal | 35,241 | 35,241 | — | — | |||||||||||||
Liabilities: | |||||||||||||||||
Common stock warrant liability (see Note 9) | (3,535 | ) | — | — | (3,535 | ) | |||||||||||
Subtotal | (3,535 | ) | — | — | (3,535 | ) | |||||||||||
Total | $ | 31,706 | $ | 35,241 | $ | — | $ | (3,535 | ) | ||||||||
Description | Fair Value at | Quoted Prices in | Significant Other | Significant | |||||||||||||
30-Sep-13 | Active Markets for | Observable | Unobservable | ||||||||||||||
Identical Assets | Market Inputs | Inputs | |||||||||||||||
(Level 1) | (Level 2) | (Level 3) | |||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 39,781 | $ | 39,781 | $ | — | $ | — | |||||||||
Subtotal | 39,781 | 39,781 | — | — | |||||||||||||
Liabilities: | |||||||||||||||||
Common stock warrant liability (see Note 9) | (6,121 | ) | — | — | (6,121 | ) | |||||||||||
Subtotal | (6,121 | ) | — | — | (6,121 | ) | |||||||||||
Total | $ | 33,660 | $ | 39,781 | $ | — | $ | (6,121 | ) | ||||||||
The Company recognizes transfers into and out of the levels indicated above on the actual date of the event or change in circumstances that caused the transfer of change. All changes within Level 3 can be found in the following Level 3 reconciliation table below: | |||||||||||||||||
Balance at September 30, 2013 | $ | (6,121 | ) | ||||||||||||||
Decrease in fair value of common stock warrant liability | 2,586 | ||||||||||||||||
Balance at December 31, 2013 | $ | (3,535 | ) | ||||||||||||||
The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative liabilities in the Company's statement of operations. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. |
PreLaunch_Inventory
Pre-Launch Inventory | 3 Months Ended |
Dec. 31, 2013 | |
Pre-Launch Inventory [Abstract] | ' |
Pre-Launch Inventory | ' |
3. Pre-Launch Inventory | |
Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Because all of its product candidates are in early stages of preclinical or clinical development, the Company currently expenses all purchases of pre-launch inventory as research and development, and expects to continue to do so until it can determine the probability of regulatory approval for the applicable product candidate. |
StockBased_Compensation
Stock-Based Compensation | 3 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Stock-Based Compensation [Abstract] | ' | ||||||||||||||||
Stock-Based Compensation | ' | ||||||||||||||||
4. Stock-Based Compensation | |||||||||||||||||
In March 2013, the Company’s stockholders approved an amendment to and restatement of the Company’s 2010 Stock Incentive Plan (as amended and restated, the “2010 Plan”). The 2010 Plan replaced the Company’s 2004 Stock Incentive Plan and 2005 Non-Employee Directors Stock Option Plan. Stock options are granted at an exercise price equal to the Company’s closing stock price on the date of the grant. Stock options vest over a period of up to four years with a contractual life of seven years. The Company estimates the fair value using the Black-Scholes pricing model. The Company uses the following assumptions in its Black Scholes valuation calculations: | |||||||||||||||||
Risk-free rate – The Company uses interest rates based on the yield of US Treasury strips on the date the award is granted and the expected term of the award. | |||||||||||||||||
Forfeitures – The Company estimates forfeitures based on actual historical and estimated future forfeitures. | |||||||||||||||||
Dividends – The Company has assumed that dividends will not be paid. | |||||||||||||||||
Volatility – The Company uses its historical volatility. | |||||||||||||||||
Expected term – The expected option term represents the period that stock based awards are expected to be outstanding based on the simplified method provided in Staff Accounting Bulletin (“SAB”) No. 107, Share- Based Payment, (“SAB No. 107”), which averages an award’s weighted-average vesting period and expected term for “plain vanilla” share options. Under SAB No. 107, options are considered to be “plain vanilla” if they have the following basic characteristics: (i) granted “at-the money”; (ii) exercisability is conditioned upon service through the vesting date; (iii) termination of service prior to vesting results in forfeiture; (iv) limited exercise period following termination of service; and (v) options are non-transferable and non-hedgeable. | |||||||||||||||||
In December 2007, the SEC issued SAB No. 110, Share-Based Payment, (“SAB No. 110”). SAB No. 110 was effective January 1, 2008 and expresses the views of the Staff of the SEC with respect to extending the use of the simplified method, as discussed in SAB No. 107, in developing an estimate of the expected term of “plain vanilla” share options in accordance with ASC Topic 718. The Company will continue to use the simplified method until it has the historical data necessary to provide a reasonable estimate of expected life in accordance with SAB No. 107, as amended by SAB No. 110. For the expected term, the Company has “plain-vanilla” stock options, and therefore used a simple average of the vesting period and the contractual term for options granted subsequent to January 1, 2006 as permitted by SAB No. 107.The Company expenses ratably over the vesting period the cost of the stock options granted to employees and non-employee directors. The total stock-based compensation cost for the three months ended December 2013 which included stock based compensation charges related to the Company’s 2005 Employee Stock Purchase Plan was $241. In comparison, the total compensation cost for the three months ended December 2012 was $375. | |||||||||||||||||
At December 31, 2013, the stock-based total compensation cost related to non-vested options not yet recognized was $2,153, which will be recognized over the next four years assuming the employees complete their service period for vesting of the options. | |||||||||||||||||
The following table summarizes the stock option activity during the three months ended December 31, 2013: | |||||||||||||||||
Number | Weighted | Weighted | Aggregate | ||||||||||||||
Average | Average | Intrinsic | |||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Life in Years | |||||||||||||||||
Outstanding options, September 30, 2013 | 1,920,051 | $ | 22.31 | 4 | 445 | ||||||||||||
Granted | 1,200,000 | $ | 2.36 | 4 | — | ||||||||||||
Exercised | — | — | — | — | |||||||||||||
Forfeited, expired | 43,712 | $ | 23.03 | — | — | ||||||||||||
Outstanding options, December 31, 2013 | 3,076,339 | $ | 14.49 | 5 | — | ||||||||||||
Exercisable options, December 31, 2013 | 1,450,266 | $ | 27.91 | 5 | $ | — | |||||||||||
The Black-Scholes pricing model assumptions for the three months ended December 31, 2012 and 2013 are determined as discussed below: | |||||||||||||||||
Three Months Ended | |||||||||||||||||
December 31, | |||||||||||||||||
2012 | 2013 | ||||||||||||||||
Expected life (in years) | 4.75 | 4.75 | |||||||||||||||
Expected volatility | 96 | % | 70 | % | |||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
Risk-free interest rate | 0.75 | % | 0.58 | % | |||||||||||||
Weighted average grant date fair value | $ | 2.4 | $ | 2.36 | |||||||||||||
Restricted Stock Units | |||||||||||||||||
The Company has granted restricted stock units (“RSUs”) to executive officers and employees pursuant to the 2010 Plan from time to time. There is no direct cost to the recipients of RSUs, except for any applicable taxes. | |||||||||||||||||
Each RSU award that was granted to the Company’s executive officers and employees represents one share of common stock. Each year following the annual vesting date, between January 1st and March 15th, the Company will issue common stock for each vested RSU. During the period when the RSU is vested but not distributed, the RSUs cannot be transferred and the grantee has no voting rights. If the Company declares a dividend, RSU recipients will receive payment based upon the percentage of RSUs that has vested prior to the date of declaration. The costs of the awards, determined as the fair market value of the shares on the grant date, are expensed per the vesting schedule outlined in the award. | |||||||||||||||||
Based on historical experience of option cancellations, the Company has estimated an annualized forfeiture rate of 7.5%. Forfeiture rates will be adjusted over the requisite service period when actual forfeitures differ, or are expected to differ, from the estimate. | |||||||||||||||||
The stock-based compensation expense associated with the RSUs has been recorded in the statement of operations and in additional paid-in-capital on the balance sheets is as follows: | |||||||||||||||||
Three Months Ended | |||||||||||||||||
December 31, | |||||||||||||||||
2012 | 2013 | ||||||||||||||||
Stock compensation expense — RSUs | $ | 90 | $ | 54 | |||||||||||||
At December 31, 2013, all of the stock-based compensation expense related to RSU awards granted under the 2004 Stock Incentive Plan and the 2010 Plan has been recognized. | |||||||||||||||||
The following table summarizes RSU activity from October 1, 2013 through December 31, 2013: | |||||||||||||||||
Shares | Weighted | ||||||||||||||||
Average | |||||||||||||||||
Grant-Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Non-vested and outstanding balance at October 1, 2013 | 31,296 | $ | 10.48 | ||||||||||||||
Changes during the period: | |||||||||||||||||
RSUs granted | — | — | |||||||||||||||
RSUs converted to common stock | — | — | |||||||||||||||
Subtotal | 31,296 | 10.48 | |||||||||||||||
Vested and not distributed | 31,296 | 10.48 | |||||||||||||||
Non-vested and outstanding RSU balance at December 31, 2013 | — | $ | — | ||||||||||||||
2005 Employee Stock Purchase Plan | |||||||||||||||||
The Company’s 2005 Employee Stock Purchase Plan (the “Purchase Plan”) was adopted by its board of directors and approved by its stockholders on March 20, 2007. The Purchase Plan became effective upon the closing of the Company’s initial public offering. The Purchase Plan is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Internal Revenue Code. | |||||||||||||||||
Under the Purchase Plan, eligible employees may contribute up to 15% of their eligible earnings for the period of that offering withheld for the purchase of common stock under the Purchase Plan. The employee’s purchase price is equal to the lower of: 85% of the fair market value per share on the start date of the offering period in which the employee is enrolled or 85% of the fair market value per share on the semi-annual purchase date. The Purchase Plan imposes a limitation upon a participant’s right to acquire common stock if immediately after the purchase the employee would own 5% or more of the total combined voting power or value of the Company’s common stock or of any of its affiliates. The Purchase Plan provides for an automatic rollover when the purchase price for a new offering period is lower than previously established purchase price(s). The Purchase Plan also provides for a one-time election that allows an employee the opportunity to enroll into a new offering period when the new offering is higher than their current offering price. This election must be made within 30 days from the start of a new offering period. Offering periods are twenty-seven months in length. The compensation charge/(credit) in connection with the Purchase Plan for the three months ended December 31, 2013 was $(1). In comparison, for the three months ended December 31, 2012, the Company expensed $(10). | |||||||||||||||||
An aggregate of 475,000 shares of common stock are reserved for issuance pursuant to purchase rights to be granted to the Company’s eligible employees under the Purchase Plan. The Purchase Plan shares are replenished annually on the first day of each calendar year by virtue of an evergreen provision. The provision allows for share replenishment equal to the lesser of 1% of the total number of shares of common stock outstanding on that date or 25,000 shares. As of December 31, 2012 and 2013, a total of 352,646 and 361,880 shares, respectively, were reserved and available for issuance under the Purchase Plan. As of December 31, 2012 and 2013, the Company has issued 97,354 and 113,120 shares, respectively, under the Purchase Plan. |
Reverse_Stock_Splits
Reverse Stock Splits | 3 Months Ended |
Dec. 31, 2013 | |
Reverse Stock Splits [Abstract] | ' |
Reverse Stock Splits | ' |
5. Reverse Stock Split | |
On June 11, 2012, the Company amended its certificate of incorporation in order to effect a one-for-four reverse split of its outstanding common stock and to fix on a post-split basis the number of authorized shares of its common stock at 25,000,000 (reduced from 100,000,000 authorized shares). As a result of the reverse stock split, each share of Company common stock outstanding at the effective time was automatically changed into one-quarter of a share of common stock. No fractional shares were issued in connection with the reverse stock split, and cash of $0.3 was paid in lieu of fractional shares. Also as a result of the reverse stock split, the number of shares of common stock subject to outstanding options, restricted stock units and warrants issued by the Company and the number of shares reserved for future issuance under the Company’s stock plans have been reduced by a factor of four. There was no alteration to the par value of the common stock or any modification of the voting rights or other terms thereof. All references in these financial statements and accompanying notes to units of common stock or per share amounts are reflective of the reverse stock split for all periods reported. |
Stockholders_Equity
Stockholders' Equity | 3 Months Ended |
Dec. 31, 2013 | |
Stockholders' Equity [Abstract] | ' |
Stockholders' Equity | ' |
6. Stockholders’ Equity | |
In November 2012, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to increase the number of authorized shares of common stock, and on December 20, 2012, the Company amended its certificate of incorporation in order to effect an increase in the number of shares of its authorized common stock, par value $.01, from 25,000,000 to 62,500,000 shares. | |
For the year ended September 30, 2013, 1,655,607 shares of the Company's Series B Convertible Preferred Stock were converted into 1,655,607 shares of common stock. | |
In August 2013, 1,813,944 shares of the Company's Series A Convertible Preferred Stock, convertible at a 4:1 ratio, were converted into 453,483 shares of common stock. |
Income_Taxes
Income Taxes | 3 Months Ended |
Dec. 31, 2013 | |
Income Taxes [Abstract] | ' |
Income Taxes | ' |
7. Income Taxes | |
The Company accounts for income taxes under FASB ASC 740-10-25 (“ASC 740-10-25”), Accounting for Income Taxes. Under ASC 740-10-25, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740-10-25, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company files U.S. federal and state tax returns and has determined that its major tax jurisdictions are the United States and Connecticut. The tax years ended in 2004 through 2013 remain open and subject to examination by the appropriate governmental agencies in the United States and Connecticut. | |
Section 382 of the Internal Revenue Code imposes limitations on the use of U.S. federal net operating losses (“NOLs”) upon a 50% or more change in ownership in the Company within a three-year period. The Company’s NOLs will continue to be available to offset taxable income (until such NOLs are either used or expire) subject to the Section 382 annual limitation. If the Section 382 annual limitation amount is not fully utilized in a particular tax year, then the unused portion from that particular tax year will be added to the Section 382 annual limitation in subsequent years. The Company has determined that ownership change, under Section 382, occurred as a result of the May 2011financing and therefore, the ability to utilize its current NOLs is further limited. | |
The Company has approximately $58 million of NOLs, which, if not used, expire beginning in 2024 through 2032. | |
The Company’s effective tax rate for the three months ended December 31, 2012 and 2013 was 0% and differs from the federal statutory rate of 34% primarily due to the effects of state income taxes and valuation allowance. |
Net_Loss_per_Share
Net Loss per Share | 3 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Net Loss Per Share [Abstract] | ' | ||||||||
Net Loss per Share | ' | ||||||||
8. Net Loss per Share | |||||||||
Basic and diluted net loss per share has been calculated by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. All potentially dilutive common shares have been excluded from the calculation of weighted average common shares outstanding, as their inclusion would be anti-dilutive. | |||||||||
The amount of options, common shares underlying warrants, common shares issuable upon conversion of preferred stock and RSUs excluded are as follows: | |||||||||
Three Months Ended | |||||||||
December 31, | |||||||||
2012 | 2013 | ||||||||
Common shares underlying warrants issued for common stock | 5,006,398 | 5,006,398 | |||||||
Common shares issuable upon conversion of Series A Preferred Stock | 453,486 | - | |||||||
Common shares issuable upon conversion of Series B Preferred Stock | 3,605,607 | 1,950,000 | |||||||
Stock options | 1,953,297 | 3,076,339 | |||||||
Restricted stock units outstanding | 68,153 | 31,296 |
Financings
Financings | 3 Months Ended | ||||
Dec. 31, 2013 | |||||
Financing [Abstract] | ' | ||||
Financings | ' | ||||
9. Financings | |||||
June 2013 Public Offering | |||||
On June 24, 2013, the Company completed an underwritten public offering of 4,482,760 shares of its common stock at a price to the public of $4.35 per share. On July 22, 2013, after the completion of its third fiscal quarter, the Company issued 236,007 additional shares of common stock, at the public offering price of $4.35 per share, in connection with the underwriters’ exercise of a portion of their over-allotment option. The Company received net proceeds from this offering, after deducting underwriting discounts, commissions and expenses, of $19.3 million. | |||||
June 2012 Private Placement | |||||
In June 2012, the Company completed a private placement (the “2012 Private Placement”) of an aggregate of 4,250,020 shares of the Company’s common stock, 3,605,607 shares of the Company’s Series B Convertible Preferred Stock and warrants to purchase an aggregate of 2,749,469 shares of common stock at an exercise price of $2.66 per share. For each unit consisting of either a share of common stock or Series B Preferred Stock and a warrant to purchase 0.35 of a share of common stock, the purchasers in the June 2012 Private Placement paid a negotiated price of $2.355. The warrants are immediately exercisable and will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. The Company received net proceeds, after deducting placement agents’ fees and other transaction expenses, of approximately $17,100 from the 2012 Private Placement. Each share of Series B Preferred Stock is convertible into one share of the Company’s common stock at any time at the option of the holder, except that the securities purchase agreement that the Company entered into in connection with the 2012 Private Placement (the “Securities Purchase Agreement”) provides that a holder will be prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of common stock then issued and outstanding. In the event of the Company’s liquidation, dissolution or winding up, holders of the Series B Preferred Stock will receive a payment equal to $0.01 per share of Series B Preferred Stock before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series B Preferred Stock, holders of Series B Preferred Stock and holders of the Company’s Series A Preferred Stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series B Preferred Stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series B Preferred Stock will be required to amend the terms of the Series B Preferred Stock. Holders of Series B Preferred Stock are entitled to receive, and the Company is required to pay, dividends on shares of the Series B Preferred Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock. | |||||
As required by the Securities Purchase Agreement, the Company filed a Registration Statement on Form S-3 (the “Registration Statement”) with the Securities and Exchange Commission (the “SEC”) on July 27, 2012, which was within 30 days after the closing of the 2012 Private Placement. The Registration Statement, which was declared effective on August 13, 2012, registers the resale of the shares of common stock and Series B Preferred Stock issued and sold in the 2012 Private Placement, the shares of common stock issuable upon conversion of the Series B Preferred Stock issued and sold in the 2012 Private Placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the 2012 Private Placement. Pursuant to the terms of the Securities Purchase Agreement, the Company agreed to pay liquidated damages to the purchasers in the 2012 Private Placement if, after effectiveness of the Registration Statement and subject to certain specified exceptions, the Company suspends the use of the Registration Statement or the Registration Statement ceases to remain continuously effective as to all the securities for which it is required to be effective (each such event, a “Registration Default”). Subject to specified exceptions, for each 30-day period or portion thereof during which a Registration Default remains uncured, the Company is obligated to pay liquidated damages to each purchaser in cash in an amount equal to 1.0% of the aggregate purchase price paid by each such purchaser in the 2012 Private Placement, up to a maximum of 8.0% of such aggregate purchase price. As of the date of these financial statements, the Company does not believe that it is probable that it will be obligated to pay any such liquidated damages. Accordingly, the Company has not established an accrual for liquidated damages. | |||||
In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the 2012 Private Placement will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date. | |||||
At December 31, 2013, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $3,031. In comparison, the fair value of the warrant liability at September 30, 2013 was $4,958. | |||||
During the three months ended December 31, 2013, the Company recorded an adjustment to fair value of common stock warrant liability of $1,927 within Other (income)/expense, to reflect a decrease in the valuation of the warrants from September 30, 2013 to December 31, 2013. | |||||
The following summarizes the changes in value of the warrant liability from September 30, 2013 through December 31, 2013: | |||||
Balance at September 30, 2013 | 4,958 | ||||
Decrease in fair value of common stock warrant liability | (1,927 | ) | |||
Balance at December 31, 2013 | 3,031 | ||||
May 2011 Registered Direct Offering | |||||
In May 2011, the Company completed a registered direct offering (the “May 2011 Offering”) of an aggregate of 3,018,736 shares of the Company’s common stock, 1,813,944 shares of the Company’s Series A Preferred Stock and warrants to purchase 2,256,929 shares of the Company’s common stock. The shares and warrants were sold in units consisting of (i) one share of common stock and (ii) one warrant to purchase 0.1625 of a share of common stock, at an exercise price of $9.92 per share of the Company’s common stock. However, one investor also purchased units consisting of one share of Series A Preferred Stock and a warrant to purchase 0.1625 of a share of common stock. No fractional warrants were issued. Each unit was sold at a price of $8.64 per unit. These units were not issued or certificated. The shares and warrants were immediately separated. The warrants will expire on May 17, 2016, five years from the original issuance date of May 18, 2011. The Company received net proceeds, after deducting placement agents’ fees and other offering expenses, of approximately $28,000 from the May 2011 Offering. Each share of Series A Preferred Stock is convertible into one quarter of a share of the Company’s common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the shares of Series A Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of the Company’s common stock then issued and outstanding. In the event of the Company’s liquidation, dissolution or winding up, holders of the Series A Preferred Stock will receive a payment equal to $0.01 per share of Series A Preferred Stock before any proceeds are distributed to the holders of the Company’s common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series A Preferred Stock, holders of Series A Preferred Stock will participate ratably in the distribution of any remaining assets with the Company’s common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series A Preferred Stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock. The Series A Preferred Stock will not be entitled to receive any dividends, unless and until specifically declared by the Company’s board of directors. | |||||
In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the May 2011 Offering will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. As per terms of the warrant, the holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date. | |||||
At December 31, 2013, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $504. In comparison, the fair value of the warrant liability at September 30, 2013 was $1,163. | |||||
During the three months ended December 31, 2013, the Company recorded an adjustment to fair value of common stock warrant liability of $659 within Other (income)/expense, to reflect a decrease in the valuation of the warrants from September 30, 2013 to December 31, 2013. | |||||
The following summarizes the changes in value of the warrant liability from September 30, 2013 through December 31, 2013: | |||||
Balance at September 30, 2013 | $ | 1,163 | |||
Decrease in fair value of common stock warrant liability | (659 | ) | |||
Balance at December 31, 2013 | $ | 504 | |||
Fair Value Assumptions Used in Accounting for Warrant Liability | |||||
The Company has determined its warrant liability to be a Level 3 fair value measurement and used the Black-Scholes valuation model to calculate, as of December 31, 2013, the fair value of the warrants issued in the June 2012 Private Placement and the May 2011 Offering. | |||||
As of December 31, 2013, the Company estimated such fair value using the following assumptions: | |||||
June 2012 Financing | 31-Dec-13 | ||||
Stock price | $ | 2.28 | |||
Exercise price | $ | 2.66 | |||
Risk-free interest rate | 0.78 | % | |||
Expected remaining term | 3.49 | ||||
Expected volatility | 82 | % | |||
Dividend yield | — | ||||
Warrants outstanding | 2,749,469 | ||||
May 2011 Offering | 31-Dec-13 | ||||
Stock price | $ | 2.28 | |||
Exercise price | $ | 9.92 | |||
Risk-free interest rate | 0.38 | % | |||
Expected remaining term | 2.38 | ||||
Expected volatility | 78 | % | |||
Dividend yield | — | ||||
Warrants outstanding | 2,256,929 | ||||
Risk-Free Interest Rate. This is the United States Treasury rate for the measurement date having a term equal to the expected remaining term of the warrant. An increase in the risk-free interest rate will increase the fair value and the associated derivative liability. | |||||
Term of Warrants. This is the period of time over which the warrant is expected to remain outstanding and is based on management’s estimate, taking into consideration the remaining contractual life. | |||||
Expected Volatility. This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. The Company uses a weighted-average of its historic volatility over the retrospective period corresponding to the expected remaining term of the warrants on the measurement date. An increase in the expected volatility will increase the fair value and the associated derivative liability. | |||||
Dividend Yield. The Company has not made any dividend payments nor does it have plans to pay dividends in the foreseeable future. An increase in the dividend yield will decrease the fair value and the associated derivative liability. | |||||
Participating Securities | |||||
If at any time the Company grants, issues or sells securities or other property to holders of any class of common stock, the holders of the warrants are entitled to also acquire those same securities as if they held the number of shares of common stock acquirable upon complete exercise of the warrants. | |||||
As such, given that the warrant holders will participate fully on any dividends or dividend equivalents, the Company determined that the warrants are participating securities and therefore are subject to ASC 260-10-55 earnings per share. These securities were excluded from the three months ended December 31, 2013 loss per share calculation since their inclusion would be anti-dilutive. |
Commitments
Commitments | 3 Months Ended |
Dec. 31, 2013 | |
Commitments [Abstract] | ' |
Commitments | ' |
10. Commitments | |
Leases | |
As of December 31, 2013, the Company leased three facilities in Danbury, Connecticut. | |
The Company renewed its lease for laboratory space in November 2013 for one year. This lease provides for annual basic lease payments of $68, plus the annual Consumers Price Index (“CPI”) increase for October, not to exceed 6%, plus operating expenses. | |
The Company also renewed its lease agreement for additional office space adjacent to its laboratory space in November 2013 for one year. This lease provides for annual basic lease payments of $31, plus the annual CPI increase for October, not to exceed 6%, plus operating expenses. | |
In November 2013, the Company renewed its lease for its corporate office for five years. This lease provides for annual basic lease payments of $388, plus the annual CPI increase for May, not to exceed 6%, plus operating expenses. | |
Rent expense for the three months ended December 31, 2013, was $165. In comparison, rent expense for the three months ended December 31, 2012, was $165. | |
Other Commitments | |
The Company has entered into certain licensing and collaboration agreements for products currently under development. The Company may be obligated in future periods to make additional payments, which would become due and payable only upon the achievement of certain research and development, regulatory, and approval milestones. The specific timing of such milestones cannot be predicted and depend upon future discretionary research and clinical developments, as well as, regulatory agency actions. Further, under the terms of certain agreements the Company may be obligated to pay commercial milestones contingent upon the realization of sales revenues and sublicense revenues. Due to the long range nature of such commercial milestones, they are neither probable at this time nor predictable, and consequently are not considered contingent milestone payment amounts. |
Government_Grants
Government Grants | 3 Months Ended |
Dec. 31, 2013 | |
Government Grants [Abstract] | ' |
Government Grants | ' |
11. Government Grants | |
Grants received are recognized as grant income when the grants become receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The Company requests cash funding under approved grants as expenses are incurred (not in advance) and reports these receipts on the statement of operations as a separate line item entitled “Government Grants.” The corresponding expenses are included in research and development expenses. In July and September 2012, the Company was awarded two National Institutes of Health grants for the development of a concentrated ultra-rapid-acting insulin formulation and a stable glucagon formulation, respectively, for use in an artificial pancreas. Both awards are for two years and total approximately $582 and $583, respectively. Work on the grant for the development of a concentrated ultra-rapid-acting insulin formulation started in August 2012 and expenses incurred were $41 during the quarter ended December 31, 2013 and $196 for the quarter ended December 31, 2012. Work on the grant for the stable glucagon formulation started in January 2013 and expenses incurred were $56. The Company reported grant income and grant receivable of $97 for the three months ended December 31, 2013. |
Fair_Value_of_Financial_Instru1
Fair Value of Financial Instruments (Tables) | 3 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Fair Value of Financial Instruments [Abstract] | ' | ||||||||||||||||
Company's financial assets and liabilities carried at fair value and measured on a recurring basis | ' | ||||||||||||||||
Description | Fair Value at | Quoted Prices in | Significant Other | Significant | |||||||||||||
31-Dec-13 | Active Markets for | Observable | Unobservable | ||||||||||||||
Identical Assets | Market Inputs | Inputs | |||||||||||||||
(Level 1) | (Level 2) | (Level 3) | |||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 35,241 | $ | 35,241 | $ | — | $ | — | |||||||||
Subtotal | 35,241 | 35,241 | — | — | |||||||||||||
Liabilities: | |||||||||||||||||
Common stock warrant liability (see Note 9) | (3,535 | ) | — | — | (3,535 | ) | |||||||||||
Subtotal | (3,535 | ) | — | — | (3,535 | ) | |||||||||||
Total | $ | 31,706 | $ | 35,241 | $ | — | $ | (3,535 | ) | ||||||||
Description | Fair Value at | Quoted Prices in | Significant Other | Significant | |||||||||||||
30-Sep-13 | Active Markets for | Observable | Unobservable | ||||||||||||||
Identical Assets | Market Inputs | Inputs | |||||||||||||||
(Level 1) | (Level 2) | (Level 3) | |||||||||||||||
Assets: | |||||||||||||||||
Cash and cash equivalents | $ | 39,781 | $ | 39,781 | $ | — | $ | — | |||||||||
Subtotal | 39,781 | 39,781 | — | — | |||||||||||||
Liabilities: | |||||||||||||||||
Common stock warrant liability (see Note 9) | (6,121 | ) | — | — | (6,121 | ) | |||||||||||
Subtotal | (6,121 | ) | — | — | (6,121 | ) | |||||||||||
Total | $ | 33,660 | $ | 39,781 | $ | — | $ | (6,121 | ) | ||||||||
Company recognizes transfers into and out of the level 3 | ' | ||||||||||||||||
Balance at September 30, 2013 | $ | (6,121 | ) | ||||||||||||||
Decrease in fair value of common stock warrant liability | 2,586 | ||||||||||||||||
Balance at December 31, 2013 | $ | (3,535 | ) | ||||||||||||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 3 Months Ended | ||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||
Stock-Based Compensation [Abstract] | ' | ||||||||||||||||
Summary of the stock option activity | ' | ||||||||||||||||
Number | Weighted | Weighted | Aggregate | ||||||||||||||
Average | Average | Intrinsic | |||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Life in Years | |||||||||||||||||
Outstanding options, September 30, 2013 | 1,920,051 | $ | 22.31 | 4 | 445 | ||||||||||||
Granted | 1,200,000 | $ | 2.36 | 4 | — | ||||||||||||
Exercised | — | — | — | — | |||||||||||||
Forfeited, expired | 43,712 | $ | 23.03 | — | — | ||||||||||||
Outstanding options, December 31, 2013 | 3,076,339 | $ | 14.49 | 5 | — | ||||||||||||
Exercisable options, December 31, 2013 | 1,450,266 | $ | 27.91 | 5 | $ | — | |||||||||||
Black-Scholes valuation model assumptions | ' | ||||||||||||||||
Three Months Ended | |||||||||||||||||
December 31, | |||||||||||||||||
2012 | 2013 | ||||||||||||||||
Expected life (in years) | 4.75 | 4.75 | |||||||||||||||
Expected volatility | 96 | % | 70 | % | |||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
Risk-free interest rate | 0.75 | % | 0.58 | % | |||||||||||||
Weighted average grant date fair value | $ | 2.4 | $ | 2.36 | |||||||||||||
Stock-based compensation expense associated with the RSUs | ' | ||||||||||||||||
Three Months Ended | |||||||||||||||||
December 31, | |||||||||||||||||
2012 | 2013 | ||||||||||||||||
Stock compensation expense — RSUs | $ | 90 | $ | 54 | |||||||||||||
Summary of RSU activity | ' | ||||||||||||||||
Shares | Weighted | ||||||||||||||||
Average | |||||||||||||||||
Grant-Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Non-vested and outstanding balance at October 1, 2013 | 31,296 | $ | 10.48 | ||||||||||||||
Changes during the period: | |||||||||||||||||
RSUs granted | — | — | |||||||||||||||
RSUs converted to common stock | — | — | |||||||||||||||
Subtotal | 31,296 | 10.48 | |||||||||||||||
Vested and not distributed | 31,296 | 10.48 | |||||||||||||||
Non-vested and outstanding RSU balance at December 31, 2013 | — | $ | — |
Net_Loss_per_Share_Tables
Net Loss per Share (Tables) | 3 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
Net Loss Per Share [Abstract] | ' | ||||||||
Dilutive common shares excluded from the calculation of weighted average common shares outstanding | ' | ||||||||
Three Months Ended | |||||||||
December 31, | |||||||||
2012 | 2013 | ||||||||
Common shares underlying warrants issued for common stock | 5,006,398 | 5,006,398 | |||||||
Common shares issuable upon conversion of Series A Preferred Stock | 453,486 | - | |||||||
Common shares issuable upon conversion of Series B Preferred Stock | 3,605,607 | 1,950,000 | |||||||
Stock options | 1,953,297 | 3,076,339 | |||||||
Restricted stock units outstanding | 68,153 | 31,296 |
Financings_Tables
Financings (Tables) | 3 Months Ended | ||||
Dec. 31, 2013 | |||||
Class of Warrant or Right [Line Items] | ' | ||||
Fair value assumptions used in accounting for warrant liability | ' | ||||
June 2012 Financing | 31-Dec-13 | ||||
Stock price | $ | 2.28 | |||
Exercise price | $ | 2.66 | |||
Risk-free interest rate | 0.78 | % | |||
Expected remaining term | 3.49 | ||||
Expected volatility | 82 | % | |||
Dividend yield | — | ||||
Warrants outstanding | 2,749,469 | ||||
May 2011 Offering | 31-Dec-13 | ||||
Stock price | $ | 2.28 | |||
Exercise price | $ | 9.92 | |||
Risk-free interest rate | 0.38 | % | |||
Expected remaining term | 2.38 | ||||
Expected volatility | 78 | % | |||
Dividend yield | — | ||||
Warrants outstanding | 2,256,929 | ||||
May 2011 registered direct offering [Member] | ' | ||||
Class of Warrant or Right [Line Items] | ' | ||||
Summary of changes in value of the warrant liability in private placement | ' | ||||
Balance at September 30, 2013 | $ | 1,163 | |||
Decrease in fair value of common stock warrant liability | (659 | ) | |||
Balance at December 31, 2013 | $ | 504 | |||
June 2012 Private Placement [Member] | ' | ||||
Class of Warrant or Right [Line Items] | ' | ||||
Summary of changes in value of the warrant liability in private placement | ' | ||||
Balance at September 30, 2013 | 4,958 | ||||
Decrease in fair value of common stock warrant liability | (1,927 | ) | |||
Balance at December 31, 2013 | 3,031 | ||||
Business_and_Basis_of_Presenta1
Business and Basis of Presentation (Details) | 1 Months Ended |
Jun. 30, 2012 | |
Business and Basis of Presentation (Textual) | ' |
Description of reverse stock split of outstanding common stock | 'one-for-four |
Fair_Value_of_Financial_Instru2
Fair Value of Financial Instruments (Details) (USD $) | Dec. 31, 2013 | Sep. 30, 2013 |
In Thousands, unless otherwise specified | ||
Assets: | ' | ' |
Cash and cash equivalents | $35,241 | $39,781 |
Liabilities: | ' | ' |
Common stock warrant liability (see Note 9) | 3,535 | 6,121 |
Recurring [Member] | ' | ' |
Assets: | ' | ' |
Cash and cash equivalents | 35,241 | 39,781 |
Subtotal | 35,241 | 39,781 |
Liabilities: | ' | ' |
Common stock warrant liability (see Note 9) | -3,535 | -6,121 |
Subtotal | -3,535 | -6,121 |
Total | 31,706 | 33,660 |
Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ' | ' |
Assets: | ' | ' |
Cash and cash equivalents | 35,241 | 39,781 |
Subtotal | 35,241 | 39,781 |
Liabilities: | ' | ' |
Common stock warrant liability (see Note 9) | ' | ' |
Subtotal | ' | ' |
Total | 35,241 | 39,781 |
Recurring [Member] | Significant Other Observable Market Inputs (Level 2) [Member] | ' | ' |
Assets: | ' | ' |
Cash and cash equivalents | ' | ' |
Subtotal | ' | ' |
Liabilities: | ' | ' |
Common stock warrant liability (see Note 9) | ' | ' |
Subtotal | ' | ' |
Total | ' | ' |
Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member] | ' | ' |
Assets: | ' | ' |
Cash and cash equivalents | ' | ' |
Subtotal | ' | ' |
Liabilities: | ' | ' |
Common stock warrant liability (see Note 9) | -3,535 | -6,121 |
Subtotal | -3,535 | -6,121 |
Total | ($3,535) | ($6,121) |
Fair_Value_of_Financial_Instru3
Fair Value of Financial Instruments (Details 1) (USD $) | 3 Months Ended |
In Thousands, unless otherwise specified | Dec. 31, 2013 |
Reconcilliation of Level 3 changes | ' |
Beginning Balance | ($6,121) |
Decrease in fair value of common stock warrant liability | 2,586 |
Ending Balance | ($3,535) |
StockBased_Compensation_Detail
Stock-Based Compensation (Details) (Stock options [Member], USD $) | 3 Months Ended |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 |
Stock options [Member] | ' |
Summary of the stock option activity | ' |
Beginning balance, Outstanding options, Number | 1,920,051 |
Granted, Number | 1,200,000 |
Excercised, Number | ' |
Forfeited, expired, Number | 43,712 |
Ending balance, Outstanding options, Number | 3,076,339 |
Exercisable options, Number | 1,450,266 |
Beginning balance, Outstanding options, Weighted Average Exercise Price | $22.31 |
Granted, Weighted Average Exercise Price | $2.36 |
Exercised, Weighted Average Exercise Price | ' |
Forfeited, expired, Weighted Average Exercise Price | $23.03 |
Ending balance, Outstanding options, Weighted Average Exercise Price | $14.49 |
Exercisable options, Weighted Average Exercise Price | $27.91 |
Outstanding options, Weighted Average Remaining Contractual Life in Years | '4 years |
Exercisable options, Weighted Average Remaining Contractual Life in Years | '5 years |
Outstanding options, Aggregate Intrinsic Value | $445 |
Granted, Aggregate Intrinsic Value | ' |
Exercised, Aggregate Intrinsic Value | ' |
Forfeited, expired, Aggregate Intrinsic Value | ' |
Outstanding options, Aggregate Intrinsic Value | ' |
Exercisable options, Aggregate Intrinsic Value | ' |
StockBased_Compensation_Detail1
Stock-Based Compensation (Details 1) (USD $) | 3 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Black-Scholes pricing model assumptions | ' | ' |
Expected life (in years) | '4 years 9 months | '4 years 9 months |
Expected volatility | 70.00% | 96.00% |
Expected dividend yield | 0.00% | 0.00% |
Risk-free interest rate | 0.58% | 0.75% |
Weighted average grant date fair value | $2.36 | $2.40 |
StockBased_Compensation_Detail2
Stock-Based Compensation (Details 2) (Restricted Stock Units [Member], USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Restricted Stock Units [Member] | ' | ' |
Stock-based compensation expense associated with the RSUs | ' | ' |
Stock compensation expense - RSUs | $54 | $90 |
StockBased_Compensation_Detail3
Stock-Based Compensation (Details 3) (USD $) | 3 Months Ended |
Dec. 31, 2013 | |
Summary of RSUs activities | ' |
Non-vested and outstanding balance | 31,296 |
Non-vested and outstanding balance, Weighted Average Grant-Date Fair Value | $10.48 |
Changes during the period: | ' |
RSUs granted, Shares | ' |
RSUs granted, Weighted Average Grant-Date Fair Value | ' |
RSUs converted to common stock, Shares | ' |
RSUs converted to common stock, Weighted average grant date fair value | ' |
Subtotal, shares | 31,296 |
Subtotal, Weighted Average Grant-Date Fair Value | $10.48 |
Vested and not distributed, Shares | 31,296 |
Vested and not distributed, Weighted average grant date fair value | $10.48 |
Non-vested and outstanding balance | ' |
Non-vested and outstanding balance, Weighted Average Grant-Date Fair Value | ' |
StockBased_Compensation_Detail4
Stock-Based Compensation (Details Textual) (USD $) | 3 Months Ended | 1 Months Ended | 3 Months Ended | |||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Mar. 31, 2010 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2012 |
2010 Stock Incentive Plan [Member] | 2010 Restricted Stock Units [Member] | 2005 Employee Stock Purchase Plan [Member] | 2005 Employee Stock Purchase Plan [Member] | |||
Stock-Based Compensation (Textual) | ' | ' | ' | ' | ' | ' |
Vesting period | ' | ' | '4 years | ' | ' | ' |
Contractual life of option granted | ' | ' | '7 years | ' | ' | ' |
Compensation cost related to employees and directors | $241 | $375 | ' | ' | ' | ' |
Total compensation cost related to non-vested options not yet recognized | 2,153 | ' | ' | ' | ' | ' |
Annual Forfeiture Rate For Employee | ' | ' | ' | 7.50% | ' | ' |
Contribution by eligible employees under purchase plan | ' | ' | ' | ' | 15.00% | ' |
Description of purchase price | ' | ' | ' | ' | 'Lower of: 85% of the fair market value per share on the start date of the offering period in which the employee is enrolled or 85% of the fair market value per share on the semi-annual purchase date. | ' |
Limitation upon a participant's right to acquire common stock | ' | ' | ' | ' | '5% or more | ' |
Maximum period within which election must be made | ' | ' | ' | ' | '30 days | ' |
Length of offering period | ' | ' | ' | ' | '27 months | ' |
Compensation charge/(credit) in connection with purchase plan | ' | ' | ' | ' | $1 | $10 |
Common stock reserved for issuance pursuant to purchase rights to be granted | ' | ' | ' | ' | 475,000 | ' |
Provision for share replenishment | ' | ' | ' | ' | 'Lesser of 1% of the total number of shares of common stock outstanding on that date or 25,000 shares. | ' |
Shares reserved and available for issuance under purchase plan | ' | ' | ' | ' | 361,880 | 352,646 |
Total shares issued under purchase plan | ' | ' | ' | ' | 113,120 | 97,354 |
Reverse_Stock_Splits_Details
Reverse Stock Splits (Details) (USD $) | 1 Months Ended | |
Jun. 30, 2012 | Jun. 11, 2012 | |
Reverse Stock Split (Textual) | ' | ' |
Number of authorized shares after post split | ' | 25,000,000 |
Authorized common shares prior to reverse stock split | ' | 100,000,000 |
Fractional shares issued from in connection with the reverse stock split | 0 | ' |
Cash paid during reverse stock splits in lieu of fractional shares | $0.30 | ' |
Stockholders_Equity_Details
Stockholders' Equity (Details) (USD $) | 1 Months Ended | 1 Months Ended | 12 Months Ended | |||
31-May-07 | Dec. 31, 2013 | Dec. 20, 2013 | Sep. 30, 2013 | Aug. 31, 2013 | Sep. 30, 2013 | |
Series A Preferred Stock [Member] | Series B Preferred Stock [Member] | |||||
Stockholders' Equity (Textual) | ' | ' | ' | ' | ' | ' |
Common stock, par value | ' | $0.01 | ' | $0.01 | ' | ' |
Common stock, shares authorized | ' | 62,500,000 | ' | 62,500,000 | ' | ' |
Common stock authorized before amendment | ' | ' | 25,000,000 | ' | ' | ' |
Preferred stock available for conversion | ' | ' | ' | ' | 1,813,944 | 1,655,607 |
Shares of common stock issued upon conversion of preferred stock | 1,601,749 | ' | ' | ' | 453,483 | 1,655,607 |
Convertible description | ' | ' | ' | ' | 'convertible at a 4:1 ratio | ' |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 3 Months Ended | |
In Millions, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Income Taxes (Textual) | ' | ' |
Limitations of federal research and development credit carryovers | '50% or more change in ownership in the Company within a three-year period. | ' |
Total federal losses (prior to the Section 382 limitation) | $58 | ' |
Expiration of net operating loss carryforwards | 'Expire beginning in 2024 through 2032. | ' |
Effective tax rate due to the effects of state income taxes and valuation allowance | 0.00% | 0.00% |
Federal statutory rate | 34.00% | ' |
Net_Loss_per_Share_Details
Net Loss per Share (Details) | 3 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Common shares underlying warrants issued for common stock [Member] | ' | ' |
Dilutive common shares excluded from the calculation of weighted average common shares outstanding | ' | ' |
Amount of options, warrants, preferred stock and RSUs | 5,006,398 | 5,006,398 |
Common shares issuable upon conversion of Series A Preferred Stock [Member] | ' | ' |
Dilutive common shares excluded from the calculation of weighted average common shares outstanding | ' | ' |
Amount of options, warrants, preferred stock and RSUs | ' | 453,486 |
Common shares issuable upon conversion of Series B Preferred Stock [Member] | ' | ' |
Dilutive common shares excluded from the calculation of weighted average common shares outstanding | ' | ' |
Amount of options, warrants, preferred stock and RSUs | 1,950,000 | 3,605,607 |
Stock options [Member] | ' | ' |
Dilutive common shares excluded from the calculation of weighted average common shares outstanding | ' | ' |
Amount of options, warrants, preferred stock and RSUs | 3,076,339 | 1,953,297 |
Restricted stock units outstanding [Member] | ' | ' |
Dilutive common shares excluded from the calculation of weighted average common shares outstanding | ' | ' |
Amount of options, warrants, preferred stock and RSUs | 31,296 | 68,153 |
Financings_Details
Financings (Details) (USD $) | 3 Months Ended |
In Thousands, unless otherwise specified | Dec. 31, 2013 |
May 2011 registered direct offering [Member] | ' |
Summary of changes in fair value of warrant liability | ' |
Beginning Balance | $1,163 |
Decrease in fair value of common stock warrant liability | -659 |
Ending Balance | 504 |
June 2012 Private Placement [Member] | ' |
Summary of changes in fair value of warrant liability | ' |
Beginning Balance | 4,958 |
Decrease in fair value of common stock warrant liability | -1,927 |
Ending Balance | $3,031 |
Financings_Details_1
Financings (Details 1) (USD $) | 3 Months Ended |
Dec. 31, 2013 | |
June 2012 Financing [Member] | ' |
Fair value assumptions used in accounting for warrant liability | ' |
Stock price | $2.28 |
Exercise price | $2.66 |
Risk-free interest rate | 0.78% |
Expected remaining term | '3 years 5 months 27 days |
Expected volatility | 82.00% |
Dividend yield | ' |
Warrants outstanding | 2,749,469 |
May 2011 Offering [Member] | ' |
Fair value assumptions used in accounting for warrant liability | ' |
Stock price | $2.28 |
Exercise price | $9.92 |
Risk-free interest rate | 0.38% |
Expected remaining term | '2 years 4 months 17 days |
Expected volatility | 78.00% |
Dividend yield | ' |
Warrants outstanding | 2,256,929 |
Financings_Details_Textual
Financings (Details Textual) (USD $) | 3 Months Ended | 12 Months Ended | 121 Months Ended | 1 Months Ended | 3 Months Ended | 0 Months Ended | 1 Months Ended | 3 Months Ended | 1 Months Ended | |||||||||||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Sep. 30, 2011 | Sep. 30, 2008 | Sep. 30, 2007 | Dec. 31, 2013 | Jul. 22, 2013 | Jun. 24, 2013 | Jun. 30, 2012 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 24, 2013 | Jun. 30, 2012 | Jun. 30, 2012 | Jun. 30, 2012 | 31-May-11 | Dec. 31, 2013 | Sep. 30, 2013 | 31-May-11 | 31-May-11 | 31-May-11 | 31-May-11 |
June 2013 Public Offering [Member] | June 2013 Public Offering [Member] | June 2012 Private Placement [Member] | June 2012 Private Placement [Member] | June 2012 Private Placement [Member] | June 2012 Private Placement [Member] | June 2012 Private Placement [Member] | June 2012 Private Placement [Member] | June 2012 Private Placement [Member] | May 2011 Offering [Member] | May 2011 Offering [Member] | May 2011 Offering [Member] | May 2011 Offering [Member] | May 2011 Offering [Member] | May 2011 Offering [Member] | Registered Direct Offering [Member] | |||||||
Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Series B Preferred Stock [Member] | Warrant [Member] | Common Stock [Member] | Series A Preferred Stock [Member] | Warrant [Member] | ||||||||||||||
Financing (Textual) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of shares under private placement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4,482,760 | 4,250,020 | 3,605,607 | 2,749,469 | ' | ' | ' | ' | ' | ' | ' |
Issuance of shares under direct registered offering | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,018,736 | 1,813,944 | 2,256,929 | ' |
Warrant exercise price | ' | ' | ' | ' | ' | ' | ' | ' | $2.66 | ' | ' | ' | ' | ' | ' | $9.92 | ' | ' | ' | ' | ' | $9.92 |
Common shares issued for each warrant | ' | ' | ' | ' | ' | ' | ' | ' | '0.35 of a share of common stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '0.1625 of a share of common stock |
Price of unit | ' | ' | ' | ' | ' | ' | $4.35 | $4.35 | $2.36 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $8.64 |
Warrants issuance date | ' | ' | ' | ' | ' | ' | ' | ' | 27-Jun-12 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 18-May-11 |
Expiration date of warrant | ' | ' | ' | ' | ' | ' | ' | ' | 26-Jun-17 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 17-May-16 |
Warrants expiration period | ' | ' | ' | ' | ' | ' | ' | ' | '5 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '5 years |
Proceed from issuance of private placement, net | ' | ' | ' | ' | ' | $8,585 | ' | $19,300 | $17,100 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $28,000 |
Common shares issued after conversion of preferred stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1 | ' | ' | ' | ' | ' | ' | ' | ' |
Mimimum benefit owned by holder on conversion of preferred stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 9.98% | ' | 9.98% | ' | ' | ' | 9.98% | ' | ' |
Per share payment to preferred stock holder before common stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $0.01 | ' | ' | ' | ' | ' | $0.01 | ' | ' |
Voting rights of preferred stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'no voting rights | ' | ' | ' | ' | ' | ' | ' | ' |
Period of filing of registration statement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'within 30 days after the closing of the 2012 Private Placement. | ' | ' | ' | ' | ' | ' | ' | ' |
Declaration date of registration statement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 13-Aug-12 | ' | ' | ' | ' | ' | ' | ' | ' |
Minimum percentage of purchase price company obligated to pay as liquidated damages | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1.00% | ' | ' | ' | ' | ' | ' | ' | ' |
Maximum percentage of purchase price company obligated to pay as liquidated damages | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 8.00% | ' | ' | ' | ' | ' | ' | ' | ' |
Fair value of warrant liability | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,031 | 5,633 | ' | ' | ' | ' | ' | 504 | 1,705 | ' | ' | ' | ' |
Follow up period of holders to pay consideration | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '30 days | ' | '30 days | ' | ' | ' | ' | ' | ' |
Warrants exercised | ' | ' | 50 | 112 | 423 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercise of warrants | ' | ' | ' | ' | ' | 585 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock and warrants to purchase additional shares of common stock | ' | ' | ' | ' | ' | ' | 236,007 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Income from adjustment to fair value of common stock warrant liability | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1,927 | ' | ' | ' | ' | ' | ' | $659 | ' | ' | ' | ' | ' |
Commitments_Details_Textual
Commitments (Details Textual) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Facility | ||
Commitments (Textual) | ' | ' |
Number of facilities leased | 3 | ' |
Rent expense | $165 | $165 |
Laboratory Space [Member] | ' | ' |
Commitments (Textual) | ' | ' |
Additionally period for renewal of lease | '1 year | ' |
Leases amendment description | 'Lease provides for annual basic lease payments of $68, plus the annual Consumers Price Index ("CPI") increase for October, not to exceed 6%, plus operating expenses. | ' |
Annual basic lease payments plus operating expenses | 68 | ' |
Percentage of increase in annual Consumers Price Index (CPI) | 6.00% | ' |
Office Space [Member] | ' | ' |
Commitments (Textual) | ' | ' |
Additionally period for renewal of lease | '1 year | ' |
Leases amendment description | 'Lease provides for annual basic lease payments of $31, plus the annual CPI increase for October, not to exceed 6%, plus operating expenses. | ' |
Annual basic lease payments plus operating expenses | 31 | ' |
Percentage of increase in annual Consumers Price Index (CPI) | 6.00% | ' |
Corporate Office [Member] | ' | ' |
Commitments (Textual) | ' | ' |
Additionally period for renewal of lease | '5 years | ' |
Leases amendment description | 'Lease provides for annual basic lease payments of $388, plus the annual CPI increase for May, not to exceed 6%, plus operating expenses. | ' |
Annual basic lease payments plus operating expenses | $388 | ' |
Percentage of increase in annual Consumers Price Index (CPI) | 6.00% | ' |
Government_Grants_Details
Government Grants (Details) (USD $) | 3 Months Ended | 121 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 |
Government Grants (Textual) | ' | ' | ' |
Description of grants awards | 'In July and September 2012, the Company was awarded two National Institutes of Health grants. | ' | ' |
Period for grants awards | '2 years | ' | ' |
Grant one received from government | $582 | ' | ' |
Grant two received from government | 583 | ' | ' |
Insulin formulation grant expenses incurred | 41 | 196 | ' |
Glucagon formulation grant expenses incurred | 56 | ' | ' |
Grant income | 97 | 196 | 731 |
Grants receivable | $97 | ' | $97 |