10-Q

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2015

OR

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________.

Commission File Number 001-33451

BIODEL INC.

(Exact name of registrant as specified in its charter)

Delaware (State or other jurisdiction of incorporation or organization)	90-0136863 (IRS Employer Identification No.)
100 Saw Mill Road Danbury, Connecticut (Address of principal executive offices)	06810 (Zip code)

(203) 796-5000

(Registrant's telephone number, including area code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes o No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes o No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer o	Accelerated filer o	Non-accelerated filer o	Smaller reporting company
		(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes  No

Indicate the number of shares outstanding of the issuer's common stock as of the latest practicable date: As of May 1, 2015 there were 62,120,322 shares of the registrant's common stock, $0.01 par value, outstanding.

BIODEL INC.

	Page
PART I — FINANCIAL INFORMATION
Item 1. Financial Statements	1
Condensed Consolidated Balance Sheets at September 30, 2014 and March 31, 2015 (unaudited)	1
Condensed Consolidated Statements of Operations (unaudited) for the Three and Six Months Ended March 31, 2014 and 2015	2
Condensed Consolidated Statements of Stockholders' Equity (unaudited) for the Six Months Ended March 31, 2015	3
Condensed Consolidated Statements of Cash Flows (unaudited) for the Six Months Ended March 31, 2014 and 2015	4
Notes to Condensed Consolidated Financial Statements (unaudited)	6
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3. Quantitative and Qualitative Disclosures About Market Risk	28
Item 4. Controls and Procedures	28
PART II — OTHER INFORMATION
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	34
Item 6. Exhibits	30
Signatures	31
EX-31.01
EX-31.02
EX-32.01 EX-101

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

Biodel Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)

		September 30, 2014			March 31, 2015
					(unaudited)
ASSETS
Current:
Cash and cash equivalents	$	24,588		$	17,753
Prepaid and other assets		316			625
Total current assets		24,904			18,378
Property and equipment, net		481			338
Intellectual property, net		40			38
Total assets	$	25,425		$	18,754
LIABILITIES AND STOCKHOLDERS' EQUITY
Current:
Accounts payable	$	172		$	346
Accrued expenses:
Clinical trial expenses		214			399
Payroll and related		958			986
Accounting and legal fees		131			222
Other		141			146
Income taxes payable		—			3
Total current liabilities		1,616			2,102
Common stock warrant liability		1,014			302
Total liabilities		2,630			2,404
Commitments
Stockholders' equity:
Convertible preferred stock, $.01 par value; 50,000,000 shares authorized; 1,950,000 and 1,909,410 issued and outstanding		19			19
Common stock, $.01 par value; 200,000,000 shares authorized; 23,079,543 and 24,620,322 issued and outstanding		231			246
Additional paid-in capital		252,104			254,687
Accumulated deficit		(229,559	)		(238,602	)
Total stockholders' equity		22,795			16,350
Total liabilities and stockholders' equity	$	25,425		$	18,754

See accompanying notes to condensed consolidated financial statements.

-1-

Biodel Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)

		Three Months Ended March 31,						Six Months Ended March 31,
		2014			2015			2014			2015
Revenue	$	—		$	—		$	—		$	—
Operating expenses:
Research and development		4,257			2,917			7,998			6,324
Government grants		(207	)		—			(304	)		—
General and administrative		1,731			1,611			3,127			3,444
Total operating expenses		5,781			4,528			10,821			9,768
Other (income) and expense:
Interest and other income		(13	)		(7	)		(29	)		(16	)
Adjustment to fair value of common stock warrant liability		426			(166	)		(2,161	)		(712	)
Loss before tax provision		(6,194	)		(4,355	)		(8,631	)		(9,040	)
Tax provision		4			1			9			3
Net loss		(6,198	)		(4,356	)		(8,640	)		(9,043	)
Net loss per share — basic and diluted	$	(0.29	)	$	(0.18	)	$	(0.41	)	$	(0.40	)
Weighted average shares outstanding — basic and diluted		21,083,237			24,369,246			21,078,404			22,809,903

See accompanying notes to condensed consolidated financial statements.

-2-

Biodel Inc.
Condensed Consolidated Statements of Stockholders' Equity
(in thousands, except share and per share amounts)

	Common Stock $.01 Par Value			Series B Preferred stock $.01 Par Value					Additional Paid in Capital			Accumulated Deficit			Total Stockholders' Equity
	Shares		Amount	Shares			Amount
Balance, September 30, 2014	23,079,543	$	231	1,950,000		$	19	$	252,104		$	(229,559	)	$	22,795
Fees associated with April 2015 offering	—		—	—			—		(100	)		—			(100	)
Proceeds from ATM facility	1,042,714		10	—			—		1,581			—			1,591
Proceeds from equity line	450,000		5						667						672
Preferred stock conversion	40,590			(40,590	)										—
Stock-based compensation	—		—	—			—		425			—			425
Proceeds from the sale of stock-ESPP	7,475		—	—			—		10			—			10
Net loss	—		—	—			—		—			(9,043	)		(9,043	)
Balance, March 31, 2015 (unaudited)	24,620,322	$	246	1,909,410		$	19	$	254,687		$	(238,602	)	$	16,350

See accompanying notes to condensed consolidated financial statements.

-3-

Biodel Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)

		Six Months Ended March 31,
		2014			2015
Cash flows from operating activities:
Net loss	$	(8,640	)	$	(9,043	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		310			164
Stock-based compensation for employees and directors		509			425
Adjustment to fair value of common stock warrant liability		(2,161	)		(712	)
(Increase) decrease in:
Grant receivable		(181	)		—
Prepaid expenses and other assets		(346	)		(309	)
Increase (decrease) in:
Accounts payable		395			174
Income taxes payable		(68	)		3
Accrued expenses and long term liabilities		(939	)		309
Total adjustments		(2,481	)		54
Net cash used in operating activities		(11,121	)		(8,989	)
Cash flows from investing activities:
Purchase of property and equipment		(32	)		(19	)
Net cash used in investing activities		(32	)		(19	)

-4-

Biodel Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)

		Six Months Ended March 31,
		2014			2015
Cash flows from financing activities:
Options exercised		48			—
Net proceeds from employee stock purchase plan		10			10
Net proceeds from ATM facility		—			1,591
Net proceeds from equity line		—			672
Fees associated with April 2015 offering		—			(100	)
Net cash provided by financing activities		58			2,173
Net (decrease) in cash and cash equivalents		(11,095	)		(6,835	)
Cash and cash equivalents, beginning of period		39,781			24,588
Cash and cash equivalents, end of period		28,686			17,753
Supplemental disclosures of cash flow information:
Cash paid for interest and income taxes was:
Interest	$	—		$	—
Income taxes		14			—
Conversion of convertible preferred stock to common stock	$	—		$	—

See accompanying notes to condensed consolidated financial statements.

-5-

Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

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 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 inactive subsidiary in the United Kingdom in October 2011 ("Biodel UK Limited").

Basis of Presentation

The condensed consolidated financial statements have been prepared by the Company and are unaudited. These condensed consolidated financial statements include Biodel UK Limited. 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 condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes included in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2014, filed with the Securities and Exchange Commission on December 19, 2014. The results of operations for the three and six months ended March 31, 2015 are not necessarily indicative of the operating results for the full fiscal year or any other interim period.

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, 2014 and March 31, 2015, 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, 2014 and March 31, 2015 for the warrants issued in the May 2011 and June 2012 financings (as defined in Note 7). 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 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:

-6-

Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

Description		Fair Value at March 31, 2015			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	17,753		$	17,753	$	—	$	—
Subtotal		17,753			17,753		—		—
Liabilities:
Common stock warrant liability (see Note 7)		(302	)		—		—		(302	)
Subtotal		(302	)		—		—		(302	)
Total	$	17,451		$	17,753	$	—	$	(302	)

Description		Fair Value at September 30, 2014			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	24,588		$	24,588	$	—	$	—
Subtotal		24,588			24,588		—		—
Liabilities:
Common stock warrant liability (see Note 7)		(1,014	)		—		—		(1,014	)
Subtotal		(1,014	)		—		—		(1,014	)
Total	$	23,574		$	24,588	$	—	$	(1,014	)

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, 2014	$	(1,014	)
Decrease in fair value of common stock warrant liability		712
Balance at March 31, 2015	$	(302	)

The unrealized gains or losses on the derivative liabilities are recorded as an adjustment to 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.

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

-7-

Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

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.

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 stock price 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 compensation cost related to options for the three and six months ended March 31, 2015 was $180 and $341, respectively. In comparison, the total compensation cost related to options for the three and six months ended March 31, 2014 was $214 and $455, respectively.

At March 31, 2015, the total compensation cost related to non-vested options not yet recognized was $1,714, which will be recognized over the next five years assuming the employees complete their service period for vesting of the options.

The following table summarizes the stock option activity during the six months ended March 31, 2015:

	Number			Weighted Average Exercise Price	Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Outstanding options, September 30, 2014	2,643,523		$	13.15	5	$	—
Granted	906,750			1.39	7		—
Forfeited, expired	(39,957	)		50.52			—
Outstanding options, March 31, 2015	3,510,316		$	9.69	5		—
Exercisable options, March 31, 2015	1,551,819		$	19.55	3	$	—

-8-

Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

The Black-Scholes pricing model assumptions for the three and six months ended March 31, 2014 and 2015 are determined as discussed below:

		Three Months Ended March 31,						Six Months Ended March 31,
		2014			2015			2014			2015
Expected life (in years)		3.77-4.75			3.77-4.75			3.77-4.75			3.77 - 4.75
Expected volatility		73-83	%		62-82	%		70 - 83	%		62 - 82	%
Expected dividend yield		0	%		0	%		0	%		0	%
Risk-free interest rate		0.69 - 0.78	%		0.99 - 1.37	%		0.58 - 0.78	%		0.96 - 1.62	%
Weighted average grant date fair value	$	3.35		$	1.39		$	2.41		$	1.39

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 10%. 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 March 31,				Six Months Ended March 31,
		2014		2015		2014		2015
Stock compensation expense — RSUs	$	—	$	50	$	54	$	84

The following table summarizes RSU activity from October 1, 2014 through March 31, 2015:

	Shares		Weighted Average Grant-Date Fair Value
Non-vested and outstanding balance at October 1, 2014	—	$	—
Changes during the period:
RSUs granted	131,128		1.57
RSUs converted to common stock	—		—
Subtotal	131,128		1.57
Vested and not distributed	—		—
Non-vested and outstanding RSU balance at March 31, 2015	131,128	$	1.57

-9-

Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

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 to be 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 and six months ended March 31, 2015 was $1 and $4, respectively. In comparison, for the three and six months ended March 31, 2014, the Company expensed $2 and $1, respectively.

An aggregate of 525,000 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 March 31, 2014 and 2015, a total of 386,880 and 401,262 shares, respectively, were reserved and available for issuance under the Purchase Plan. As of March 31, 2014 and 2015, the Company has issued 113,120 and 123,738 shares, respectively, under the Purchase Plan.

5. 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 through 2014 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") if there is more than a 50% 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 2034.

-10-

Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

The Company's effective tax rate for the three and six months ended March 31, 2014 and 2015 was 0% and differs from the federal statutory rate of 34% due to net operating losses. A valuation allowance for the full amount of the deferred tax assets has been established as of March 31, 2014 and 2015.

6. Net Loss per Share

Basic and diluted net loss per share has been calculated by dividing net loss 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 March 31,		Six Months Ended March 31,
	2014	2015	2014	2015
Common shares underlying warrants issued for common stock	5,006,398	5,006,398	5,006,398	5,006,398
Common shares issuable upon conversion of Series A Preferred Stock	—	—	—	—
Common shares issuable upon conversion of Series B Preferred Stock	1,950,000	1,909,410	1,950,000	1,909,410
Stock options	2,885,525	3,510,316	2,885,525	3,510,316
Restricted stock units outstanding	—	131,128	—	131,128

7. Financings

July 2014 Equity Line Purchase Agreement

On July 25, 2014, the Company entered into a purchase agreement (the "Purchase Agreement"), together with a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"). Under the terms, and subject to the conditions of the Purchase Agreement, the Company had the right to sell to LPC, and LPC was obligated to purchase, up to $15 million in shares of common stock, subject to certain limitations, from time to time over the 36-month period commencing on the date that a registration statement, which the Company agreed to file with the SEC pursuant to the Registration Rights Agreement, was declared effective by the SEC and a final prospectus in connection therewith was filed. The Company's registration statement was declared effective on September 2, 2014. The Company was obligated, within twenty (20) calendar days, to file with the SEC an initial Registration Statement covering the maximum number of Registrable Securities as shall be permitted to be included thereon in accordance with applicable SEC rules, regulations and interpretations so as to permit the resale of such Registrable Securities by LPC under Rule 415 under the Securities Act at then prevailing market prices (and not fixed prices), as mutually determined by both the Company and LPC in consultation with their respective legal counsel, subject to the aggregate number of authorized shares of the Company's Common Stock then available for issuance in its Certificate of Incorporation. The Company was required to use its commercially reasonable efforts to keep the Registration Statement effective pursuant to Rule 415 promulgated under the Securities Act and available for the resale by LPC of all of the Registrable Securities covered thereby at all times until the date on which LPC shall have resold all the Registrable Securities covered thereby and no available amount remains under the Purchase Agreement. The Company could direct LPC, at its sole discretion and subject to certain conditions, to purchase up to 150,000 shares of common stock in any business day, increasing to amounts of up to 250,000 shares, depending upon the closing sale price of the common stock. In addition, the Company could direct LPC to purchase additional shares as accelerated purchases if, on the date of a regular purchase, the closing sale price of the common stock was not below $2.50 per share (subject to adjustment). The purchase price of shares of common stock purchased under the Purchase Agreement were based on the prevailing market prices of such shares at the time of sales, but in no event could the Company sell shares to LPC on a day when the closing sale price of the common stock was less than a floor price of $1.50 per share (subject to adjustment). The Company could control the timing and amount of any sales of common stock to LPC under the Purchase Agreement. As consideration for LPC's commitment to purchase shares of common stock pursuant to the Purchase Agreement, the Company issued to LPC 95,000 shares of

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Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

Common Stock as commitment shares, with a fair market value of $189, which is recorded as the cost of capital in additional paid in capital. During the three and six months ended March 31, 2015, the Company sold 150,000 and 450,000 shares of common stock, respectively and received proceeds, net of expenses, of $204 and $672, respectively. As of March 31, 2015, the Company sold an aggregate of 750,000 shares of common stock pursuant to the Purchase Agreement, and received proceeds, net of expenses, of $1,161.

On April 14, 2015, the Company provided written notice of termination of the Purchase Agreement pursuant to the terms of the agreement. The termination became effective on April 16, 2015. (See Note 10)

May 2013 At-the-Market Issuance Sales Agreement

In May 2013, the Company entered into an At-the-Market Issuance Sales Agreement (the "Sales Agreement") with MLV & Co. LLC ("MLV"), under which the Company may initially issue and sell shares of common stock having aggregate sales proceeds of up to $12.4 million from time to time through MLV as the Company's sales agent. During the three and six months ended March 31, 2015, the Company sold 976,657 and 1,042,714 shares of common stock, respectively and received proceeds, net of expenses, of $1.5 million and $1.6 million, respectively. As of March 31, 2015, the Company sold an aggregate of 2,607,535 shares of common stock pursuant to the Sales Agreement and received proceeds, net of sales agent commissions and expenses, of $4.7 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 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

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Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

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 March 31, 2015, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $302. In comparison, the fair value of the warrant liability at September 30, 2014 was $994.

During the three and six months ended March 31, 2015, the Company recorded an adjustment to fair value of common stock warrant liability of $165 and $692, respectively within Other (income), to reflect a decrease in the valuation of the warrants from September 30, 2014 to March 31, 2015.

The following summarizes the changes in value of the warrant liability from September 30, 2014 through March 31, 2015:

Balance at September 30, 2014	994
Decrease in fair value of common stock warrant liability	(692	)
Balance at March 31, 2015	302

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 was 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 was 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 would 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 would 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 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 was required to amend the terms of the Series A Preferred Stock. The Series

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Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

A Preferred Stock would not be entitled to receive any dividends, unless and until specifically declared by the Company's board of directors. As of March 31, 2015, all Series A Preferred Stock has been converted into common stock and none are outstanding.

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 March 31, 2015, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $0. In comparison, the fair value of the warrant liability at September 30, 2014 was $20.

During the three and six months ended March 31, 2015, the Company recorded an adjustment to fair value of common stock warrant liability of $1 and $20, respectively within Other (income), to reflect a decrease in the valuation of the warrants from September 30, 2014 to March 31, 2015.

The following summarizes the changes in value of the warrant liability from September 30, 2014 through March 31, 2015:

Balance at September 30, 2014	$	20
Decrease in fair value of common stock warrant liability		(20	)
Balance at March 31, 2015	$	—

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 March 31, 2015, the fair value of the warrants issued in the 2012 Private Placement and the May 2011 Offering.

As of March 31, 2015, the Company estimated such fair value using the following assumptions:

June 2012 Financing		March 31, 2015
Stock price	$	1.19
Exercise price	$	2.66
Risk-free interest rate		0.56	%
Expected remaining term (years)		2.24
Expected volatility		58	%
Dividend yield		—
Warrants outstanding		2,749,469

May 2011 Offering		March 31, 2015
Stock price	$	1.19
Exercise price	$	9.92
Risk-free interest rate		0.26	%
Expected remaining term (years)		1.13
Expected volatility		41	%
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.

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Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

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 and six months ended March 31, 2014 and 2015 loss per share calculation since their inclusion would be anti-dilutive.

8. Commitments

Leases

As of March 31, 2015, the Company leased three facilities in Danbury, Connecticut.

The Company renewed its lease for laboratory space in October 2014 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 October 2014 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 and six months ended March 31, 2015 was $167 and $333, respectively. In comparison, rent expense for the three and six months ended March 31, 2014, was $145 and $310, respectively.

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.

9. 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

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Biodel Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(unaudited)

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 completed in June 2014. Expenses incurred were $0 for the three and six months ended March 31, 2015 and $57 and $98, respectively for the three and six months ended March 31, 2014.

Work on the grant for the stable glucagon formulation started in January 2013 and completed in June 2014. Expenses incurred were $0 for the three and six months ended March 31, 2015 and $150 and $206 respectively, for the three and six months ended March 31, 2014.

The Company reported grant income of $0 for the three and six months ended March 31, 2015 and $207 and $304 respectively, for the three and six months ended March 31, 2014.

10. Subsequent Events

2015 Public Offering

On April 20, 2015, after the completion of its second fiscal quarter, the Company completed an underwritten public offering of 37,500,000 shares of its common stock (which includes the full exercise of the underwriter's option to purchase 4,891,304 shares to cover overallotments), at a price to the public of $0.92 per share. The Company received net proceeds from this offering, after deducting underwriting discounts, commissions and expenses of $32,069.

On April 14, 2015, the Company provided written notice of termination of the Purchase Agreement pursuant to the terms of the agreement. The termination became effective on April 16, 2015. (See Note 7)

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FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report on Form 10-Q regarding our strategy, future operations, 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.

Our forward-looking statements in this Quarterly Report on Form 10-Q 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:

•the progress, timing or success of our research and development and clinical programs for our product candidates, particularly our glucagon emergency management, or GEM, product candidate, which comprises lyophilized glucagon and an aqueous diluent in an automatic reconstitution device, and our concentrated ultra-rapid-acting insulin product candidate, BIOD-531, which uses regular human insulin, or RHI, as the active pharmaceutical ingredient in a concentration of 400 units per milliliter;

•our ability to conduct the development work necessary to finalize the formulation and presentation of our GEM product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the submission of a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for that product candidate;

•the ability and willingness of our existing strategic partners, service providers and suppliers, upon which we rely in the advancement of our product candidates, to meet the obligations set forth in our agreements with them, including Unilife Medical Solutions, Inc., or Unilife, which is responsible for designing and manufacturing the device intended for use with our GEM product candidate, as well as delivering three registration lots of the filled and finished GEM device required for submitting an NDA to the FDA;

•the success of our formulation development work to improve the stability of our newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and pharmacodynamic characteristics;

•the results of our real-time stability programs for our glucagon-, RHI-, and insulin analog-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;

•our ability to accurately anticipate technical challenges that we may face in the development of our glucagon-, RHI-, and insulin analog-based product candidates;

•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FFDCA;

•our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;

•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;

•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations;

•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation;

•the ability of our contract manufacturing organizations or collaborators to properly manufacture our products in our final dosage form and in the quantities we may require;

•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization one or more product candidates;

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•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and

•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and the ability to fulfill our needs for additional financing.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2014, and in our other subsequent public filings with the Securities and Exchange Commission that could cause actual results or events to differ materially from the forward-looking statements that we make.

You should read this Quarterly Report and the documents that we have filed as exhibits to the Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. It is routine for internal projections and expectations to change as the year, or each quarter in the year, progresses, and therefore it should be clearly understood that the internal projections and beliefs upon which we base our expectations are made as of the date of this Quarterly Report on Form 10-Q and may change prior to the end of each quarter or the year. While we may elect to update forward-looking statements at some point in the future, we do not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise.

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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should read the "Risk Factors" section of our report on Form 10-K for the fiscal year ended September 30, 2014 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our formulation technologies to existing drugs in order to improve their therapeutic profiles. Our glucagon formulations and presentations are designed to be stable at room temperature and are intended for use by caregivers with little to no medical training as a rescue treatment for diabetes patients experiencing severe hypoglycemia. Our proprietary insulin formulations are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. We refer to these as "ultra-rapid-acting" insulin formulations.

Our lead product candidate is a glucagon emergency management, or GEM, device that is intended to treat diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. GEM is comprised of lyophilized glucagon and an aqueous diluent in a proprietary injection device from Unilife Medical Solutions, Inc., or Unilife. The GEM device is a dual-chamber design that automatically reconstitutes lyophilized glucagon immediately prior to injection and features automatic needle retraction on full dose delivery. We have designed the GEM device with the goal of optimizing its ease of use for patient caregivers in an emergency.

In the third quarter of calendar year 2014, we submitted an Investigational New Drug application, or IND, to the U.S. Food and Drug Administration, or FDA, for our GEM product candidate. We have completed a Phase 1 clinical trial to assess the pharmacokinetic and pharmacodynamic profiles of BIOD-961, the reconstituted glucagon formulation intended for use in the GEM device. In the Phase 1 clinical trial, the overall pharmacokinetic and pharmacodynamic profiles of BIOD-961 were statistically indistinguishable from the two comparator glucagon formulations marketed by Eli Lilly and Novo Nordisk. In April 2015, we announced results from a formative human factors study of our GEM product candidate in which the GEM device demonstrated a substantial improvement in ease-of-use, frequency of successful administration and reduction in the error rate when compared to the commercially available glucagon kits. We intend to complete a summative human factors study and pivotal trial for our GEM product candidate by the end of calendar year 2015 and submit a New Drug Application, or NDA, to the FDA in mid-2016.

In addition to our GEM product candidate, we are developing ultra-rapid-acting proprietary insulin formulations that are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. For example, BIOD-123, which was evaluated in a Phase 2 clinical trial, combines recombinant human insulin, or RHI, with our 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. More recently, we have developed BIOD-531, a concentrated ultra-rapid-acting insulin formulation. BIOD-531 contains 400 units of RHI per milliliter (instead of the standard 100 units per milliliter), and, like BIOD-123, is formulated with EDTA, citrate and magnesium sulfate. When delivered by subcutaneous injection, BIOD-531 is characterized by a rapid onset of action and a prolonged duration of action, which we believe could address an unmet medical need for a concentrated insulin with an initial rate of absorption superior to that of existing concentrated insulins and prandial/basal premixed insulins. We intend to initiate, in the second calendar quarter of 2015, a multi-dose Phase 2 clinical trial in Type 2 diabetes patients with moderate insulin resistance who will receive BIOD-531 or Humalog® Mix 75/25 twice daily for a total of 18 weeks.

In addition to our RHI-based ultra-rapid-acting insulin formulations, we are using our proprietary excipients to develop analog-based ultra-rapid-acting insulin formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog®, or insulin aspart, the active pharmaceutical ingredient in NovoLog®.

We were incorporated in December 2003 and commenced active operations in January 2004. To date, we have generated no revenues and have incurred significant losses. We expect to continue to incur operating losses as we continue our efforts to develop and commercialize our product candidates. We have financed our operations and internal growth through various financing transactions, including our initial public offering in May 2007 and several subsequent transactions, including, more recently, our April 2015 underwritten public offering. In addition, we recently raised funds

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pursuant to our At-the-Market Issuance Sales Agreement with MLV & Co. LLC, or MLV, and our equity line stock purchase agreement with Lincoln Park Capital Fund, LLC, or LPC. We may issue shares of our common stock pursuant to our agreement with MLV in the future. On April 14, 2015, we provided written notice of termination of our equity line purchase agreement with LPC, pursuant to the terms of the agreement. The termination became effective on April 16, 2015. We have devoted substantially all of our efforts to research and development activities, including clinical trials. Our net loss was $4.4 million and $9.0 million for the three and six months ended March 31, 2015.

As of March 31, 2015 we had approximately $17.8 million in cash and cash equivalents and on April 20, 2015, we closed our previously-announced underwritten public offering, which resulted in net proceeds of an additional $32.1 million, compared to $24.6 million in cash and cash equivalents as of September 30, 2014. We believe that our existing cash and cash equivalents will be sufficient to fund our anticipated operating expenses and capital expenditures at least through the end of the first calendar quarter of 2017.

Financial Operations Overview

Revenues

To date, we have generated no revenues. We do not expect to begin generating any revenues unless any of our product candidates receive marketing approval, or if we receive payments in connection with strategic collaborations that we may enter into for the commercialization of our product candidates.

Research and Development Expenses

Research and development expenses consist of the costs associated with our basic research activities, as well as the costs associated with our drug development efforts, conducting preclinical studies and clinical trials, manufacturing efforts and activities related to regulatory filings. Our research and development expenses consist of:

•external research and development expenses incurred under agreements with third-party contract research organizations and investigative sites, third-party manufacturing organizations and consultants;

•employee-related expenses, which include salaries and benefits for the personnel involved in our preclinical and clinical drug development and manufacturing activities; and

•facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies.

We intend to focus our research and development efforts on conducting a summative human factors study and pivotal clinical trial in support of an NDA for our GEM product, as well as conduct a multi-dose Phase 2 clinical trial with BIOD-531. We anticipate that our research and development expenses for the fiscal year ending September 30, 2015 will increase as compared to the fiscal year ended September 30, 2014, as we continue to:

•undertake manufacturing activities to conduct the development work necessary to finalize the formulation and design of our GEM product candidate and in support of clinical trials with that product candidate;

•produce validation and registration batches of our GEM product candidate to support the submission of an NDA with the FDA;

•conduct clinical trials with our GEM product candidate, including at least one pivotal clinical trial required for FDA approval of an NDA;

•conduct clinical trials with our BIOD-531 product candidate, including a planned Phase 2, parallel group study in patients with Type 2 diabetes over a six-month treatment period;

•conduct the required stability, preclinical and human factors and user acceptability studies to support the approval of our GEM device and one or more insulin injection devices intended for use with BIOD-531; and

•purchase active pharmaceutical ingredients and other materials in support of our product candidates.

Over the longer term, we anticipate that these expenses will increase further as we:

•prepare and file an NDA for our GEM product candidate; and

•conduct later stage clinical trials of BIOD-531, including, potentially, pivotal clinical trials required for FDA approval of an NDA.

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We have used our employee and infrastructure resources across multiple research projects and our drug development programs. A substantial majority of our research and development expenses incurred to date are attributable to our ultra-rapid-acting insulin program.

In July and September 2012, we were 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. The July 2012 award was intended to fund research to develop a proprietary ultra-rapid-insulin product candidate at high concentrations suited to provide sufficient quantities of insulin in an external artificial pancreas pump device that has limited volume capacity. The July 2012 award was for two years and totaled $582 thousand. The September 2012 award was intended to fund research to develop a proprietary glucagon product candidate optimized to algorithmically deliver glucagon as part of a bi-hormonal closed loop system to mitigate hypoglycemic events. The September 2012 award was for two years and totaled $583 thousand. For the three and six months ended March 31, 2014 and 2015, $207 and $304 of grant income was recognized respectively. As of September 30, 2014, all grant income was earned and recorded.

The following table illustrates, for each period presented, our research and development costs by nature of the cost.

		Three Months Ended March 31,				Six Months Ended March 31,
		2014		2015		2014		2015
		(in thousands)
Research and development expenses:
Preclinical expenses	$	1,051	$	1,020	$	2,850	$	1,990
Manufacturing expenses		1,660		628		2,330		1,494
Clinical/regulatory expenses		1,546		1,269		2,818		2,840
Total	$	4,257	$	2,917	$	7,998	$	6,324

The following table illustrates, for the three and six months ended March 31, 2014 and 2015, our research and development costs by project.

		Three Months Ended March 31,					Six Months Ended March 31,
		2014		2015			2014		2015
Ultra-rapid-acting insulin formulations:
RHI	$	200	$	1		$	396	$	11
Analog		410		(3	)		1,140		156
Glucagon Emergency Management (GEM)		2,023		910			2,901		1,957
BIOD-531		538		1,011			1,397		2,185
Other		1,086		998			2,164		2,015
Total	$	4,257	$	2,917		$	7,998	$	6,324

The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, specific timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of, or the period, if any, in which material net cash inflows may commence from our product candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

•the progress, timing or success of our research and development and clinical programs for our product candidates, particularly our GEM product candidate and our BIOD-531 product candidate;

•our ability to conduct the development work necessary to finalize the formulation and presentation of our GEM product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the submission of an NDA for that candidate;

•the ability and willingness of our existing strategic partners, service providers and suppliers, upon which we rely in the advancement of our product candidates, to meet the obligations set forth in our agreements with them, including Unilife, which is responsible for designing and manufacturing the device intended for use with our GEM product candidate, as well as delivering three registration lots of the filled and finished GEM device required for submitting an NDA to the FDA;

•the success of our formulation development work to improve the stability of our newer ultra-and rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and pharmacodynamic characteristics;

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•the results of our real-time stability programs for our glucagon-, RHI-, and insulin analog-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;

•our ability to accurately anticipate technical challenges that we may face in the development of our glucagon-, RHI-, and insulin analog-based product candidates;

•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;

•our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;

•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;

•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations;

•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation;

•the ability of our contract manufacturing organizations or collaborators to manufacture our products in our final dosage form and in the quantities we may require;

•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization of one or more product candidates;

•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and

•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and the ability to fulfill our needs for additional financing.

A change in the outcome of any of these variables with respect to the development of ultra-rapid-acting insulin formulations or our liquid glucagon formulation, could mean a significant change in the costs and timing associated with product development

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related expenses for personnel, including stock-based compensation expenses, in our executive, legal, accounting, finance and information technology functions. Other general and administrative expenses include travel expenses, costs associated with industry conventions, professional fees, such as legal and accounting fees and consulting costs and facility-related costs not otherwise allocated to research and development expense.

We anticipate that our general and administrative core expenses in the fiscal year ending September 30, 2015 will remain substantially the same as in the fiscal year ended September 30, 2014 as we continue to focus our efforts on product formulation activities and begin advancing our product candidates into later stage clinical trials, including Phase 3 pivotal trials. Over the longer term, however, these expenses could increase as we prepare to file an NDA in support of our GEM product candidate and, possibly, commence pre-commercialization activities.

Warrant Liability

In June 2012, we issued warrants to purchase 2,749,469 shares of our common stock at an exercise price of $2.66 per share in connection with our June 2012 private placement. These warrants will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. In May 2011, we issued warrants to purchase 2,256,929 shares of our common stock at an exercise price of $9.92 per share in connection with our May 2011 registered direct offering. These warrants will expire on May 17, 2016, five years from the original issuance date of May 18, 2011. Under the terms of both the 2012 warrants and the 2011 warrants, if we enter into a merger or change of control transaction, the holders of the warrants will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require us to purchase the unexercised warrants at the Black-Scholes value (as defined in the

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applicable 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, we recognize the 2012 and 2011 warrants as liabilities at their fair value on each reporting date.

We use the Black-Scholes valuation model to estimate the fair value of the warrants. The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the expected 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. Using this model, we recorded an initial warrant liability of $4.8 million for the 2012 warrants and $9.4 million for the 2011 warrants, in each case as of the initial warrant issuance date. The liability for both the 2012 and 2011 warrants is revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption "Adjustment to fair value of common stock warrant liability."

Interest Income

Interest income consists of interest earned on our cash and cash equivalents and marketable securities. In November 2007, our board of directors approved investment policy guidelines, the primary objectives of which are the preservation of capital, the maintenance of liquidity and maintenance of appropriate fiduciary control - subject to our business objectives and tax situation. We have maintained an investment strategy of investing primarily in a premier commercial money market account, which consists primarily of short-term debt securities issued by the U.S. government, Treasury securities and U.S. government agencies. We intend to maintain this conservative strategy for the fiscal year ending September 30, 2015.

Critical Accounting Policies and Significant Judgments and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements that have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and assumptions. We base our estimates on historical experience and on various assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Our significant accounting policies are described in Note 2 to our audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2014 and in the notes to our consolidated financial statements included in this Quarterly Report on Form 10-Q. We believe that our accounting policies relating to research and development costs, warrant liability, and stock-based compensation are the most critical to aid you in fully understanding and evaluating our financial condition and results of operations. These policies are described under "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2014. There have been no material changes to such policies since the filing of such Annual Report.

Results of Operations

Three Months Ended March 31, 2014 Compared to Three Months Ended March 31, 2015

Revenue. We did not recognize any revenue during the three months ended March 31, 2014 or 2015.

Research and Development Expenses.

		Three Months Ended March 31,				Decrease
		2014		2015		$	%
		(in thousands)
Research and Development	$	4,257	$	2,917	$	1,340	31.5	%

Research and development expenses were $2.9 million for the three months ended March 31, 2015, a decrease of $1.3 million, or approximately 31.5%, from $4.3 million for the three months ended March 31, 2014. This decrease was primarily due to a $1.0 million reduction in device development expenses and a decrease of $0.3 million in clinical trial

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costs. Stock-based compensation included in research and development expenses were $0.1 million for the three months ended March 31, 2015 and the three months ended March 31, 2014.

General and Administrative Expenses.

		Three Months Ended March 31,				Decrease
		2014		2015		$	%
		(in thousands)
General and Administrative	$	1,731	$	1,611	$	120	6.9	%

General and administrative expenses were approximately $1.6 million for the three months ended March 31, 2015, a decrease of $0.1 million, or 6.9%, from $1.7 million for the three months ended March 31, 2014. Stock-based compensation expenses were $0.2 million for both the three months ended March 31, 2015 and March 31, 2014.

Interest and Other Income.

		Three Months Ended March 31,				Decrease
		2014		2015		$	%
		(in thousands)
Interest and Other Income	$	13	$	7	$	6	46.2	%

Interest and other income was $7 thousand for the three months ended March 31, 2015, compared to $13 thousand for the three months ended March 31, 2014.

Adjustment to Fair Value of Common Stock Warrant Liability

		Three Months Ended March 31,					Decrease
		2014		2015			$	%
		(in thousands)
Adjustment to fair value of common stock warrant liability	$	426	$	(166	)	$	592	139.0	%

The change to fair value of common stock warrant liability during the three months ended March 31, 2015 was primarily a result of a decrease in the price of our common stock from $1.33 per share as of December 31, 2014 to $1.19 per share as of March 31, 2015. The change to fair value of common stock warrant liability during the three months ended March 31, 2014 was primarily a result of an increase in the price of our common stock from $2.28 per share as of December 31, 2013 to $2.73 per share as of March 31, 2014.

Net Loss and Net Loss per Share

		Three Months Ended March 31,						Decrease
		2014			2015			$	%
		(in thousands)
Net loss	$	(6,198	)	$	(4,356	)	$	1,842	29.7	%
Net loss per share	$	(0.29	)	$	(0.18	)

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Net loss was $4.4 million, or $(0.18) per share, for the three months ended March 31, 2015, compared to $6.2 million, or $(0.29) per share, for the three months ended March 31, 2014. The decrease in net loss was primarily attributable to the decreased expenses described above. We expect our losses to continue for the foreseeable future as we continue our development efforts.

Six Months Ended March 31, 2014 Compared to Six Months Ended March 31, 2015

Revenue. We did not recognize any revenue during the six months ended March 31, 2014 or 2015.

Research and Development Expenses.

		Six Months Ended March 31,				Decrease
		2014		2015		$	%
		(in thousands)
Research and Development	$	7,998	$	6,324	$	1,674	20.9	%

Research and development expenses were $6.3 million for the six months ended March 31, 2015, a decrease of $1.7 million, or 20.9%, from $8.0 million for the six months ended March 31, 2014. This decrease was primarily due to a $1.1 million decrease in device development expense and a decrease in animal studies and API of $1.0 million, offset by an increase of $0.5 million in clinical trial expense.

Research and development expenses for the six months ended March 31, 2014 and 2015 include $0.2 million and $0.1 million, respectively, in stock-based compensation expense.

General and Administrative Expenses.

		Six Months Ended March 31,				Increase
		2014		2015		$	%
		(in thousands)
General and Administrative	$	3,127	$	3,444	$	317	10.1	%

General and administrative expenses were approximately $3.4 million for the six months ended March 31, 2015, an increase of $0.3 million, or 10.1%, from $3.1 million for the six months ended March 31, 2014. This increase was primarily due to an increase in professional fees of $0.4 million offset by a decrease in depreciation expense $0.1 million. General and administrative expenses for the six months ended March 31, 2014 and 2015 include $0.4 million and $0.3 million, respectively, in stock-based compensation expense.

Interest and Other Income.

		Six Months Ended March 31,				Decrease
		2014		2015		$	%
		(in thousands)
Interest and Other Income	$	29	$	16	$	13	44.8	%

Interest and other income was $16 thousand for the six months ended March 31, 2015, compared to $29 thousand for the six months ended March 31, 2014.

Adjustment to Fair Value of Common Stock Warrant Liability

		Six Months Ended March 31,						Increase
		2014			2015			$	%
		(in thousands)
Adjustment to fair value of common stock warrant liability	$	(2,161	)	$	(712	)	$	1,449	67.1	%

The change to fair value of common stock warrant liability during the six months ended March 31, 2015 was primarily a result of a decrease in the price of our common stock from $1.67 per share as of September 30, 2014 to $1.19 per share as of March 31, 2015. The change to fair value of common stock warrant liability during the six months ended

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March 31, 2014 was primarily a result of a decrease in the price of our common stock from $3.15 per share as of September 30, 2013 to $2.73 per share as of March 31, 2014.

Net Loss and Net Loss per Share

		Six Months Ended March 31,						Increase
		2014			2015			$	%
		(in thousands)
Net loss	$	(8,640	)	$	(9,043	)	$	403	4.7	%
Net loss per share	$	(0.41	)	$	(0.40	)

Net loss was $9.0 million, or $(0.40) per share, for the six months ended March 31, 2015 compared to $8.6 million, or $(0.41) per share, for the six months ended March 31, 2014. We expect our losses to continue for the foreseeable future as we continue our development efforts.

Liquidity and Capital Resources

Sources of Liquidity and Cash Flows

As a result of our significant research and development expenditures and the lack of any approved products or other sources of revenue, we have not been profitable and have generated significant operating losses since we were incorporated in 2003. We initially funded our research and development operations through aggregate gross proceeds of $26.6 million from our private financing transactions that we completed prior to our initial public offering. We received an aggregate of approximately $239.8 million from our initial public offering in May 2007, our follow-on offering in February 2008, our registered direct offerings in August 2010 and May 2011, our private placement in June 2012, our public offering in June 2013, our sales agreement with MLV, our purchase agreement with LPC, and our public offering in April 2015.

At March 31, 2015, we had cash and cash equivalents totaling approximately $17.8 million, and on April 20, 2015, we closed our previously-announced underwritten public offering, which resulted in net proceeds of an additional $32.1 million. We currently invest our excess funds in a premium commercial money market fund with one major financial institution. We plan to continue to invest our cash and cash equivalents in accordance with our approved investment policy guidelines, which set forth our policy to hold investment securities to maturity.

Net cash used in operating activities was $9.0 million for the six months ended March 31, 2015 and $11.1 million for the six months ended March 31, 2014. This decrease was primarily due to decreased clinical trial expenses during the period.

Net cash used in investing activities was $19 thousand for the six months ended March 31, 2015 and $32 thousand for the six months ended March 31, 2014. This decrease was primarily due to a decrease in the purchase of laboratory equipment.

Net cash provided by financing activities was $2.2 million for the six months ended March 31, 2015 and $58 thousand for the six months ended March 31, 2014. Net cash provided by financing activities for the six months ended March 31, 2015 reflect proceeds from the sale of our common stock through our equity line, ATM and our employee stock purchase plan. Net cash provided by financing activities for the six months ended March 31, 2014 reflect proceeds from employees exercising options and proceeds from the sale of our common stock through our employee stock purchase plan.

Funding Requirements

We believe that our existing cash and cash equivalents at April 30, 2015 will be sufficient to fund our anticipated operating expenses and capital expenditures at least through the end of the first calendar quarter of 2017. We have based this estimate upon assumptions that may prove to be wrong and we could use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

•the progress, timing or success of our research and development and clinical programs for our product candidates, particularly our GEM product candidate and our BIOD-531 product candidate;

•our ability to conduct the development work necessary to finalize the formulation and presentation of our GEM product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the submission of an NDA for that candidate;

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•the ability and willingness of our existing strategic partners, service providers and suppliers, upon which we rely in the advancement of our product candidates, to meet the obligations set forth in our agreements with them, including Unilife, which is responsible for designing and manufacturing the device intended for use with our GEM product candidate, as well as delivering three registration lots of the filled and finished GEM device required for submitting an NDA to the FDA;

•the success of our formulation development work to improve the stability of our newer ultra-and rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and pharmacodynamic characteristics;

•the results of our real-time stability programs for our glucagon-, RHI-, and insulin analog-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;

•our ability to accurately anticipate technical challenges that we may face in the development of our glucagon-, RHI-, and insulin analog-based product candidates;

•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;

•our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;

•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;

•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations;

•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation;

•the ability of our contract manufacturing organizations or collaborators to manufacture our products in our final dosage form and in the quantities we may require;

•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization of one or more product candidates;

•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and

•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and the ability to fulfill our needs for additional financing.

We do not anticipate generating product revenue for the next few years. In the absence of additional funding, we expect our continuing operating losses to result in increases in our cash used in operations over the next several years. To the extent our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Other than our agreement with MLV, we do not currently have any commitments for future external funding.

Currently, there are warrants outstanding from our May 2011 Offering and our 2012 Private Placement which have exercise prices of $9.92 and $2.66, respectively.  These warrants will expire, if unexercised, on May 17, 2016 and June 26, 2017, respectively.

While we continue to pursue cost saving initiatives to reduce operating expenses, we will also need to raise additional funds and periodically explore sources of equity or debt financing. We may seek to raise such capital through public or private equity financings, partnerships, joint ventures, debt financings, bank borrowings or other sources. However, additional funding may not be available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing shareholders may result. If we fail to obtain additional capital when

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needed, we may be required to delay, scale back, or eliminate some or all of our research and development programs. The accompanying financial statements do not include any adjustments that may result from the outcome of this uncertainty.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our exposure to market risk is limited to our cash, cash equivalents and marketable securities. We invest in high-quality financial instruments, as permitted by the terms of our investment policy guidelines. Currently, our excess funds are invested in a premium commercial money market fund with one major financial institution. We do not hedge interest rate exposure. A portion of our investments may be subject to interest rate risk and could fall in value if interest rates were to increase. The effective duration of our portfolio is currently less than one year, which we believe limits interest rate and credit risk.

Because most of our transactions are denominated in United States dollars, we do not have any material exposure to fluctuations in currency exchange rates.

Item 4. Controls and Procedures

Management's Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2015. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2015, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in internal controls

No change in our internal control over financial reporting (defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended March 31, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II — OTHER INFORMATION

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Reference is made to the description of the sale of common stock during the quarter ended March 31, 2015 pursuant to the Company's Purchase Agreement with LPC set forth in Note 7 to the condensed consolidated financial statements set forth in this Quarterly Report on Form 10Q.

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Item 6. Exhibits

Exhibit No.	Description
31.01	Chief Executive Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.02	Chief Financial Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.01	Chief Executive Officer and Chief Financial Officer—Certification pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002.
101	Interactive data files pursuant to Rule 405 of Regulation S-T.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	BIODEL INC.
Dated: May XX, 2015	By:	/s/ Gary Gemignani
		Gary Gemignani, Chief Financial Officer
		(Duly authorized officer and principal financial officer)

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Exhibit No.	Description
31.01	Chief Executive Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.02	Chief Financial Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.01	Chief Executive Officer and Chief Financial Officer—Certification pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002.
101	Interactive data files pursuant to Rule 405 of Regulation S-T.

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EX-31.01

Exhibit 31.01

CERTIFICATION

I, Errol B. De Souza, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Biodel Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Dated: May XX, 2015	/s/ Errol B. De Souza
	Errol B. De Souza, President and
	Chief Executive Officer

EX-31.02 3 d32224_ex31-2.htm EX-31.02

Exhibit 31.02

CERTIFICATION

I, Gary Gemignani, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Biodel Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Dated: May xx, 2015	/s/ Gary Gemignani
	Gary Gemignani, Chief Financial Officer

EX-31.02

Exhibit 31.02

CERTIFICATION

I, Gary Gemignani, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Biodel Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Dated: May xx, 2015	/s/ Gary Gemignani
	Gary Gemignani, Chief Financial Officer

XML

Commitments (Details) (USD $) In Thousands, unless otherwise specified	3 Months Ended		6 Months Ended
	Mar. 31, 2015 Facility	Mar. 31, 2014	Mar. 31, 2015 Facility	Mar. 31, 2014
Commitments (Textual)
Number of facilities leased	3		3
Rent expense	$ 167	$ 145	$ 333	$ 310
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%

XML

Stock-Based Compensation (Details 2) (Restricted Stock Units [Member], USD $) In Thousands, unless otherwise specified	3 Months Ended		6 Months Ended
	Mar. 31, 2015	Mar. 31, 2014	Mar. 31, 2015	Mar. 31, 2014
Restricted Stock Units [Member]
Stock-based compensation expense associated with the RSUs
Stock compensation expense - RSUs	$ 50		$ 84	$ 54

XML

Pre-Launch Inventory

6 Months Ended

Mar. 31, 2015

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 currentlyexpenses 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.

XML

Net Loss per Share (Details)	3 Months Ended		6 Months Ended
	Mar. 31, 2015	Mar. 31, 2014	Mar. 31, 2015	Mar. 31, 2014
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	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
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	1,909,410	1,950,000	1,909,410	1,950,000
Stock options [Member]
Dilutive common shares excluded from the calculation of weighted average common shares outstanding
Amount of options, warrants, preferred stock and RSUs	3,510,316	2,885,525	3,510,316	2,885,525
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	131,128		131,128

XML

Income Taxes (Details) (USD $)
In Millions, unless otherwise specified

3 Months Ended

6 Months Ended

Mar. 31, 2015

Mar. 31, 2014

Mar. 31, 2015

Mar. 31, 2014

Income Taxes (Textual)

Limitations of federal research and development credit carryovers

If there is more than a 50% change in ownership in the Company within a three-year period.

Operating loss carryforwards

$ 58

$ 58

Expiration of net operating loss carryforwards

Expire beginning in 2024 through 2034.

Effective tax rate due to the effects of state income taxes and valuation allowance

0.00%

0.00%

0.00%

0.00%

Federal statutory rate

34.00%

34.00%

34.00%

34.00%

XML

Financings (Details) (USD $) In Thousands, unless otherwise specified	6 Months Ended
	Mar. 31, 2015
June 2012 Private Placement [Member]
Summary of changes in fair value of warrant liability
Beginning Balance	$ 994
Decrease in fair value of common stock warrant liability	(692)
Ending Balance	302
May 2011 Registered Direct Offering [Member]
Summary of changes in fair value of warrant liability
Beginning Balance	20
Decrease in fair value of common stock warrant liability	(20)
Ending Balance

XML

Financings (Details 1) (USD $)	6 Months Ended
	Mar. 31, 2015
June 2012 Financing [Member]
Fair value assumptions used in accounting for warrant liability
Stock price	$ 1.19
Exercise price	$ 2.66
Risk-free interest rate	0.56%
Expected remaining term (years)	2 years 2 months 27 days
Expected volatility	58.00%
Dividend yield
Warrants outstanding	2,749,469
May 2011 Offering [Member]
Fair value assumptions used in accounting for warrant liability
Stock price	$ 1.19
Exercise price	$ 9.92
Risk-free interest rate	0.26%
Expected remaining term (years)	1 year 1 month 17 days
Expected volatility	41.00%
Dividend yield
Warrants outstanding	2,256,929

XML

Fair Value of Financial Instruments

6 Months Ended

Mar. 31, 2015

Fair Value of Financial Instruments [Abstract]

Fair Value of Financial Instruments

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, 2014 and March 31, 2015, 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, 2014 and March 31, 2015 for the warrants issued in the May 2011 and June 2012 financings (as defined in Note 7). 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 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 March 31, 2015			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	17,753		$	17,753	$	—	$	—
Subtotal		17,753			17,753		—		—
Liabilities:
Common stock warrant liability (see Note 7)		(302	)		—		—		(302	)
Subtotal		(302	)		—		—		(302	)
Total	$	17,451		$	17,753	$	—	$	(302	)

Description		Fair Value at September 30, 2014			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	24,588		$	24,588	$	—	$	—
Subtotal		24,588			24,588		—		—
Liabilities:
Common stock warrant liability (see Note 7)		(1,014	)		—		—		(1,014	)
Subtotal		(1,014	)		—		—		(1,014	)
Total	$	23,574		$	24,588	$	—	$	(1,014	)

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, 2014	$	(1,014	)
Decrease in fair value of common stock warrant liability		712
Balance at March 31, 2015	$	(302	)

The unrealized gains or losses on the derivative liabilities are recorded as an adjustment to 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.

XML

Financings (Details Textual) (USD $)

6 Months Ended

1 Months Ended

3 Months Ended

1 Months Ended

Mar. 31, 2015

Jul. 25, 2014

Mar. 31, 2015

May 31, 2013

Jun. 30, 2012

May 31, 2011

Sep. 30, 2014

Financing (Textual)

Stock issued as commitment shares, fair value

$ 672,000

Common Stock [Member]

Financing (Textual)

Number of shares issued in transaction

750,000

Proceeds from sale of stock

1,161,000

July 2014 Purchase Agreement [Member]

Financing (Textual)

Purchase obligation in shares of common stock

15,000,000

Term of purchase agreement

36 months

Number of shares issued in transaction

450,000

150,000

Stock issued as commitment shares

95,000

Stock issued as commitment shares, fair value

189,000

Purchase agreement, description

The Company's registration statement was declared effective on September 2, 2014. The Company was obligated, within twenty (20) calendar days.

Proceeds from sale of stock

672,000

204,000

July 2014 Purchase Agreement [Member] | Minimum [Member]

Financing (Textual)

Sale of stock, price per share

$ 1.50

Number of shares issued in transaction

150,000

July 2014 Purchase Agreement [Member] | Maximum [Member]

Financing (Textual)

Sale of stock, price per share

$ 2.50

Number of shares issued in transaction

250,000

May 2013 At-the-Market Issuance Sales Agreement [Member]

Financing (Textual)

Number of shares issued in transaction

1,042,714

976,657

Proceeds from sale of stock

1,600,000

1,500,000

12,400,000

May 2013 At-the-Market Issuance Sales Agreement [Member] | MLV & Co. [Member]

Financing (Textual)

Number of shares issued in transaction

2,607,535

Proceeds from sale of stock

4,700,000

June 2012 Private Placement [Member]

Financing (Textual)

Negotiated price terms

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 2012 Private Placement paid a negotiated price of $2.355.

Decrease in fair value of common stock warrant liability

692,000

165,000

Fair value of warrant liability

302,000

302,000

994,000

June 2012 Private Placement [Member] | Series B Preferred Stock [Member]

Financing (Textual)

Common shares issued after conversion of preferred stock

1

June 2012 Private Placement [Member] | Private Placement [Member] | Common Stock [Member]

Financing (Textual)

Number of shares issued in transaction

4,250,020

June 2012 Private Placement [Member] | Private Placement [Member] | Series B Preferred Stock [Member]

Financing (Textual)

Number of shares issued in transaction

3,605,607

June 2012 Private Placement [Member] | Private Placement [Member] | Warrant [Member]

Financing (Textual)

Warrants issued to purchase common stock

2,749,469

June 2012 Private Placement [Member] | Series B Preferred Warrants [Member]

Financing (Textual)

Warrant exercise price

2.66

Sale of stock, price per share

2.355

Warrants issuance date

Jun. 27, 2012

Warrants expiration date

Jun. 26, 2017

Warrants expiration period

5 years

Net proceeds from issuance of Common stock and warrant

17,100,000

Mimimum benefit owned by holder on conversion of preferred stock

9.98%

Per share payment to preferred stock holder before common stock

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

Aug. 13, 2012

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%

Follow up period of holders to pay consideration

30 days

Convertible preferred stock, terms of conversion

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.

May 2011 registered direct offering [Member]

Financing (Textual)

Mimimum benefit owned by holder on conversion of preferred stock

9.98%

Per share payment to preferred stock holder before common stock

$ 0.01

Follow up period of holders to pay consideration

30 days

Decrease in fair value of common stock warrant liability

20,000

1,000

Fair value of warrant liability

0

0

20,000

May 2011 registered direct offering [Member] | Common Stock [Member]

Financing (Textual)

Number of shares issued in transaction

3,018,736

May 2011 registered direct offering [Member] | Series A Preferred Stock [Member]

Financing (Textual)

Number of shares issued in transaction

1,813,944

May 2011 registered direct offering [Member] | Series A Warrants [Member]

Financing (Textual)

Warrant exercise price

$ 9.92

Sale of stock, price per share

$ 8.64

Warrants issuance date

May 18, 2011

Warrants expiration date

May 17, 2016

Warrants expiration period

5 years

Net proceeds from issuance of Common stock and warrant

$ 28,000,000

Conversion of stock, description

One warrant to purchase 0.1625 of a share of common stock.

Warrants issued to purchase common stock

2,256,929

XML

Condensed Consolidated Balance Sheets (USD $) In Thousands, unless otherwise specified	Mar. 31, 2015	Sep. 30, 2014
Current:
Cash and cash equivalents	$ 17,753	$ 24,588
Prepaid and other assets	625	316
Total current assets	18,378	24,904
Property and equipment, net	338	481
Intellectual property, net	38	40
Total assets	18,754	25,425
Current:
Accounts payable	346	172
Accrued expenses:
Clinical trial expenses	399	214
Payroll and related	986	958
Accounting and legal fees	222	131
Other	146	141
Income taxes payable	3
Total current liabilities	2,102	1,616
Common stock warrant liability	302	1,014
Total liabilities	2,404	2,630
Commitments
Stockholders' equity:
Convertible preferred stock, $.01 par value; 50,000,000 shares authorized; 1,950,000 and 1,909,410 issued and outstanding	19	19
Common stock, $.01 par value; 200,000,000 shares authorized; 23,079,543 and 24,620,322 issued and outstanding	246	231
Additional paid-in capital	254,687	252,104
Accumulated deficit	(238,602)	(229,559)
Total stockholders' equity	16,350	22,795
Total liabilities and stockholders' equity	$ 18,754	$ 25,425

XML

Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) In Thousands, unless otherwise specified	6 Months Ended
	Mar. 31, 2015	Mar. 31, 2014
Cash flows from operating activities:
Net loss	$ (9,043)	$ (8,640)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	164	310
Stock-based compensation for employees and directors	425	509
Adjustment to fair value of common stock warrant liability	(712)	(2,161)
(Increase) decrease in:
Grant receivable		(181)
Prepaid expenses and other assets	(309)	(346)
Increase (decrease) in:
Accounts payable	174	395
Income taxes payable	3	(68)
Accrued expenses and long term liabilities	309	(939)
Total adjustments	54	(2,481)
Net cash used in operating activities	(8,989)	(11,121)
Cash flows from investing activities:
Purchase of property and equipment	(19)	(32)
Net cash used in investing activities	(19)	(32)
Cash flows from financing activities:
Options exercised		48
Net proceeds from employee stock purchase plan	10	10
Net proceeds from ATM facility	1,591
Net proceeds from equity line	672
Fees associated with April 2015 offering	(100)
Net cash provided by financing activities	2,173	58
Net (decrease) in cash and cash equivalents	(6,835)	(11,095)
Cash and cash equivalents, beginning of period	24,588	39,781
Cash and cash equivalents, end of period	17,753	28,686
Cash paid for interest and income taxes was:
Interest
Income taxes		14
Conversion of convertible preferred stock to common stock

XML

Subsequent Events (Details) (Subsequent Event [Member], 2015 Public Offering [Member], USD $) In Thousands, except Share data, unless otherwise specified	0 Months Ended
	Apr. 20, 2015
Subsequent Event [Member] | 2015 Public Offering [Member]
Subsequent Events (Textual)
Shares of common stock issued	37,500,000
Options to purchase shares	4,891,304
Sale of stock, price per share	$ 0.92
Proceeds from sale of stock	$ 32,069

XML

Fair Value of Financial Instruments (Details 1) (USD $) In Thousands, unless otherwise specified	6 Months Ended
	Mar. 31, 2015
Reconcilliation of Level 3 changes
Beginning Balance	$ (1,014)
Decrease in fair value of common stock warrant liability	712
Ending Balance	$ (302)

XML

Stock-Based Compensation (Details 1) (USD $)	3 Months Ended		6 Months Ended
	Mar. 31, 2015	Mar. 31, 2014	Mar. 31, 2015	Mar. 31, 2014
Black-Scholes pricing model assumptions
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Weighted average grant date fair value	$ 1.39	$ 3.35	$ 1.39	$ 2.41
Minimum [Member]
Black-Scholes pricing model assumptions
Expected life (in years)	3 years 9 months 7 days	3 years 9 months 7 days	3 years 9 months 7 days	3 years 9 months 7 days
Expected volatility	62.00%	73.00%	62.00%	70.00%
Risk-free interest rate	0.99%	0.69%	0.96%	0.58%
Maximum [Member]
Black-Scholes pricing model assumptions
Expected life (in years)	4 years 9 months	4 years 9 months	4 years 9 months	4 years 9 months
Expected volatility	82.00%	83.00%	82.00%	83.00%
Risk-free interest rate	1.37%	0.78%	1.62%	0.78%

XML

Business and Basis of Presentation

6 Months Ended

Mar. 31, 2015

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 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 inactive subsidiary in the United Kingdom in October 2011 ("Biodel UK Limited").

Basis of Presentation

The condensed consolidated financial statements have been prepared by the Company and are unaudited. These condensed consolidated financial statements include Biodel UK Limited. 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 condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes included in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2014, filed with the Securities and Exchange Commission on December 19, 2014. The results of operations for the three and six months ended March 31, 2015 are not necessarily indicative of the operating results for the full fiscal year or any other interim period.

XML

Condensed Consolidated Balance Sheets (Parenthetical) (USD $)	Mar. 31, 2015	Sep. 30, 2014
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	1,909,410	1,950,000
Preferred stock, shares outstanding	1,909,410	1,950,000
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued	24,620,322	23,079,543
Common stock, shares outstanding	24,620,322	23,079,543

XML

Fair Value of Financial Instruments (Tables)

6 Months Ended

Mar. 31, 2015

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 March 31, 2015			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	17,753		$	17,753	$	—	$	—
Subtotal		17,753			17,753		—		—
Liabilities:
Common stock warrant liability (see Note 7)		(302	)		—		—		(302	)
Subtotal		(302	)		—		—		(302	)
Total	$	17,451		$	17,753	$	—	$	(302	)

Description		Fair Value at September 30, 2014			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	24,588		$	24,588	$	—	$	—
Subtotal		24,588			24,588		—		—
Liabilities:
Common stock warrant liability (see Note 7)		(1,014	)		—		—		(1,014	)
Subtotal		(1,014	)		—		—		(1,014	)
Total	$	23,574		$	24,588	$	—	$	(1,014	)

Company recognizes transfers into and out of the level 3

Balance at September 30, 2014	$	(1,014	)
Decrease in fair value of common stock warrant liability		712
Balance at March 31, 2015	$	(302	)

XML

Document and Entity Information	6 Months Ended
	Mar. 31, 2015	May 01, 2015
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	Mar. 31, 2015
Document Fiscal Year Focus	2015
Document Fiscal Period Focus	Q2
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		62,120,322

XML

Stock-Based Compensation (Tables)

6 Months Ended

Mar. 31, 2015

Stock-Based Compensation [Abstract]

Summary of the stock option activity

	Number			Weighted Average Exercise Price	Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Outstanding options, September 30, 2014	2,643,523		$	13.15	5	$	—
Granted	906,750			1.39	7		—
Forfeited, expired	(39,957	)		50.52			—
Outstanding options, March 31, 2015	3,510,316		$	9.69	5		—
Exercisable options, March 31, 2015	1,551,819		$	19.55	3	$	—

Black-Scholes valuation model assumptions

		Three Months Ended March 31,						Six Months Ended March 31,
		2014			2015			2014			2015
Expected life (in years)		3.77-4.75			3.77-4.75			3.77-4.75			3.77 - 4.75
Expected volatility		73-83	%		62-82	%		70 - 83	%		62 - 82	%
Expected dividend yield		0	%		0	%		0	%		0	%
Risk-free interest rate		0.69 - 0.78	%		0.99 - 1.37	%		0.58 - 0.78	%		0.96 - 1.62	%
Weighted average grant date fair value	$	3.35		$	1.39		$	2.41		$	1.39

Stock-based compensation expense associated with the RSUs

		Three Months Ended March 31,				Six Months Ended March 31,
		2014		2015		2014		2015
Stock compensation expense — RSUs	$	—	$	50	$	54	$	84

Summary of RSU activity

	Shares		Weighted Average Grant-Date Fair Value
Non-vested and outstanding balance at October 1, 2014	—	$	—
Changes during the period:
RSUs granted	131,128		1.57
RSUs converted to common stock	—		—
Subtotal	131,128		1.57
Vested and not distributed	—		—
Non-vested and outstanding RSU balance at March 31, 2015	131,128	$	1.57

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Condensed Consolidated Statements of Operations (Unaudited) (USD $) In Thousands, except Share data, unless otherwise specified	3 Months Ended		6 Months Ended
	Mar. 31, 2015	Mar. 31, 2014	Mar. 31, 2015	Mar. 31, 2014
Income Statement [Abstract]
Revenue
Operating expenses:
Research and development	2,917	4,257	6,324	7,998
Government grants	0	(207)	0	(304)
General and administrative	1,611	1,731	3,444	3,127
Total operating expenses	4,528	5,781	9,768	10,821
Other (income) and expense:
Interest and other income	(7)	(13)	(16)	(29)
Adjustment to fair value of common stock warrant liability	(166)	426	(712)	(2,161)
Loss before tax provision	(4,355)	(6,194)	(9,040)	(8,631)
Tax provision	1	4	3	9
Net loss	$ (4,356)	$ (6,198)	$ (9,043)	$ (8,640)
Net loss per share - basic and diluted	$ (0.18)	$ (0.29)	$ (0.40)	$ (0.41)
Weighted average shares outstanding - basic and diluted	24,369,246	21,083,237	22,809,903	21,078,404

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Net Loss per Share

6 Months Ended

Mar. 31, 2015

Net Loss Per Share [Abstract]

Net Loss per Share

6. Net Loss per Share

Basic and diluted net loss per share has been calculated by dividing net loss 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 March 31,				Six Months Ended March 31,
	2014		2015		2014		2015
Common shares underlying warrants issued for common stock		5,006,398		5,006,398		5,006,398		5,006,398
Common shares issuable upon conversion of Series A Preferred Stock		—		—		—		—
Common shares issuable upon conversion of Series B Preferred Stock		1,950,000		1,909,410		1,950,000		1,909,410
Stock options		2,885,525		3,510,316		2,885,525		3,510,316
Restricted stock units outstanding		—		131,128		—		131,128

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Income Taxes

6 Months Ended

Mar. 31, 2015

Income Taxes [Abstract]

Income taxes

5. 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 through 2014 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") if there is more than a 50% 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 2034.

The Company's effective tax rate for the three and six months ended March 31, 2014 and 2015 was 0% and differs from the federal statutory rate of 34% due to net operating losses. A valuation allowance for the full amount of the deferred tax assets has been established as of March 31, 2014 and 2015.

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Stock-Based Compensation (Details) (Stock options [Member], USD $)	6 Months Ended
	Mar. 31, 2015
Stock options [Member]
Summary of the stock option activity
Beginning balance, Outstanding options, Number	2,643,523
Granted, Number	906,750
Forfeited, expired, Number	(39,957)
Ending balance, Outstanding options, Number	3,510,316
Exercisable options, Number	1,551,819
Beginning balance, Outstanding options, Weighted Average Exercise Price	$ 13.15
Granted, Weighted Average Exercise Price	$ 1.39
Forfeited, expired, Weighted Average Exercise Price	$ 50.52
Ending balance, Outstanding options, Weighted Average Exercise Price	$ 9.69
Exercisable options, Weighted Average Exercise Price	$ 19.55
Beginning balance, Outstanding options, Weighted Average Remaining Contractual Life in Years	5 years
Granted, Weighted Average Remaining Contractual Life in Years	7 years
Ending balance, Outstanding options, Weighted Average Remaining Contractual Life in Years	5 years
Exercisable options, Weighted Average Remaining Contractual Life in Years	3 years
Beginning balance, Outstanding options, Aggregate Intrinsic Value
Granted, Aggregate Intrinsic Value
Forfeited, expired, Aggregate Intrinsic Value
Ending balance, Outstanding options, Aggregate Intrinsic Value
Exercisable options, Aggregate Intrinsic Value

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Net Loss per Share (Tables)

6 Months Ended

Mar. 31, 2015

Net Loss Per Share [Abstract]

Dilutive common shares excluded from the calculation of weighted average common shares outstanding

	Three Months Ended March 31,		Six Months Ended March 31,
	2014	2015	2014	2015
Common shares underlying warrants issued for common stock	5,006,398	5,006,398	5,006,398	5,006,398
Common shares issuable upon conversion of Series A Preferred Stock	—	—	—	—
Common shares issuable upon conversion of Series B Preferred Stock	1,950,000	1,909,410	1,950,000	1,909,410
Stock options	2,885,525	3,510,316	2,885,525	3,510,316
Restricted stock units outstanding	—	131,128	—	131,128

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Government Grants

6 Months Ended

Mar. 31, 2015

Government Grants [Abstract]

Government Grants

9. 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 completed in June 2014. Expenses incurred were $0 for the three and six months ended March 31, 2015 and $57 and $98, respectively for the three and six months ended March 31, 2014.

Work on the grant for the stable glucagon formulation started in January 2013 and completed in June 2014. Expenses incurred were $0 for the three and six months ended March 31, 2015 and $150 and $206 respectively, for the three and six months ended March 31, 2014.

The Company reported grant income of $0 for the three and six months ended March 31, 2015 and $207 and $304 respectively, for the three and six months ended March 31, 2014.

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Financings

6 Months Ended

Mar. 31, 2015

Financing [Abstract]

Financings

7. Financings

July 2014 Equity Line Purchase Agreement

On July 25, 2014, the Company entered into a purchase agreement (the "Purchase Agreement"), together with a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"). Under the terms, and subject to the conditions of the Purchase Agreement, the Company had the right to sell to LPC, and LPC was obligated to purchase, up to $15 million in shares of common stock, subject to certain limitations, from time to time over the 36-month period commencing on the date that a registration statement, which the Company agreed to file with the SEC pursuant to the Registration Rights Agreement, was declared effective by the SEC and a final prospectus in connection therewith was filed. The Company's registration statement was declared effective on September 2, 2014. The Company was obligated, within twenty (20) calendar days, to file with the SEC an initial Registration Statement covering the maximum number of Registrable Securities as shall be permitted to be included thereon in accordance with applicable SEC rules, regulations and interpretations so as to permit the resale of such Registrable Securities by LPC under Rule 415 under the Securities Act at then prevailing market prices (and not fixed prices), as mutually determined by both the Company and LPC in consultation with their respective legal counsel, subject to the aggregate number of authorized shares of the Company's Common Stock then available for issuance in its Certificate of Incorporation. The Company was required to use its commercially reasonable efforts to keep the Registration Statement effective pursuant to Rule 415 promulgated under the Securities Act and available for the resale by LPC of all of the Registrable Securities covered thereby at all times until the date on which LPC shall have resold all the Registrable Securities covered thereby and no available amount remains under the Purchase Agreement. The Company could direct LPC, at its sole discretion and subject to certain conditions, to purchase up to 150,000 shares of common stock in any business day, increasing to amounts of up to 250,000 shares, depending upon the closing sale price of the common stock. In addition, the Company could direct LPC to purchase additional shares as accelerated purchases if, on the date of a regular purchase, the closing sale price of the common stock was not below $2.50 per share (subject to adjustment). The purchase price of shares of common stock purchased under the Purchase Agreement were based on the prevailing market prices of such shares at the time of sales, but in no event could the Company sell shares to LPC on a day when the closing sale price of the common stock was less than a floor price of $1.50 per share (subject to adjustment). The Company could control the timing and amount of any sales of common stock to LPC under the Purchase Agreement. As consideration for LPC's commitment to purchase shares of common stock pursuant to the Purchase Agreement, the Company issued to LPC 95,000 shares of Common Stock as commitment shares, with a fair market value of $189, which is recorded as the cost of capital in additional paid in capital. During the three and six months ended March 31, 2015, the Company sold 150,000 and 450,000 shares of common stock, respectively and received proceeds, net of expenses, of $204 and $672, respectively. As of March 31, 2015, the Company sold an aggregate of 750,000 shares of common stock pursuant to the Purchase Agreement, and received proceeds, net of expenses, of $1,161.

On April 14, 2015, the Company provided written notice of termination of the Purchase Agreement pursuant to the terms of the agreement. The termination became effective on April 16, 2015. (See Note 10)

May 2013 At-the-Market Issuance Sales Agreement

In May 2013, the Company entered into an At-the-Market Issuance Sales Agreement (the "Sales Agreement") with MLV & Co. LLC ("MLV"), under which the Company may initially issue and sell shares of common stock having aggregate sales proceeds of up to $12.4 million from time to time through MLV as the Company's sales agent. During the three and six months ended March 31, 2015, the Company sold 976,657 and 1,042,714 shares of common stock, respectively and received proceeds, net of expenses, of $1.5 million and $1.6 million, respectively. As of March 31, 2015, the Company sold an aggregate of 2,607,535 shares of common stock pursuant to the Sales Agreement and received proceeds, net of sales agent commissions and expenses, of $4.7 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 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, Pidends 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 Pidends (other than Pidends in the form of common stock) actually paid on shares of the common stock when, as and if such Pidends (other than Pidends 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 March 31, 2015, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $302. In comparison, the fair value of the warrant liability at September 30, 2014 was $994.

During the three and six months ended March 31, 2015, the Company recorded an adjustment to fair value of common stock warrant liability of $165 and $692, respectively within Other (income), to reflect a decrease in the valuation of the warrants from September 30, 2014 to March 31, 2015.

The following summarizes the changes in value of the warrant liability from September 30, 2014 through March 31, 2015:

Balance at September 30, 2014	994
Decrease in fair value of common stock warrant liability	(692	)
Balance at March 31, 2015	302

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 was 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 was 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 would 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 would 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 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 was required to amend the terms of the Series A Preferred Stock. The Series

A Preferred Stock would not be entitled to receive any Pidends, unless and until specifically declared by the Company's board of directors. As of March 31, 2015, all Series A Preferred Stock has been converted into common stock and none are outstanding.

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 March 31, 2015, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $0. In comparison, the fair value of the warrant liability at September 30, 2014 was $20.

During the three and six months ended March 31, 2015, the Company recorded an adjustment to fair value of common stock warrant liability of $1 and $20, respectively within Other (income), to reflect a decrease in the valuation of the warrants from September 30, 2014 to March 31, 2015.

The following summarizes the changes in value of the warrant liability from September 30, 2014 through March 31, 2015:

Balance at September 30, 2014	$	20
Decrease in fair value of common stock warrant liability		(20	)
Balance at March 31, 2015	$	—

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 March 31, 2015, the fair value of the warrants issued in the 2012 Private Placement and the May 2011 Offering.

As of March 31, 2015, the Company estimated such fair value using the following assumptions:

June 2012 Financing	March 31, 2015
Stock price	$	1.19
Exercise price	$	2.66
Risk-free interest rate		0.56	%
Expected remaining term (years)		2.24
Expected volatility		58	%
Pidend yield		—
Warrants outstanding		2,749,469

May 2011 Offering	March 31, 2015
Stock price	$	1.19
Exercise price	$	9.92
Risk-free interest rate		0.26	%
Expected remaining term (years)		1.13
Expected volatility		41	%
Pidend 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.

Pidend Yield. The Company has not made any Pidend payments nor does it have plans to pay Pidends in the foreseeable future. An increase in the Pidend 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 Pidends or Pidend 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 and six months ended March 31, 2014 and 2015 loss per share calculation since their inclusion would be anti-dilutive.

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Commitments

6 Months Ended

Mar. 31, 2015

Commitments [Abstract]

Commitments

8. Commitments

Leases

As of March 31, 2015, the Company leased three facilities in Danbury, Connecticut.

The Company renewed its lease for laboratory space in October 2014 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 October 2014 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 and six months ended March 31, 2015 was $167 and $333, respectively. In comparison, rent expense for the three and six months ended March 31, 2014, was $145 and $310, respectively.

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.

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Subsequent Events

6 Months Ended

Mar. 31, 2015

Subsequent Events [Abstract]

Subsequent Events

10. Subsequent Events

2015 Public Offering

On April 20, 2015, after the completion of its second fiscal quarter, the Company completed an underwritten public offering of 37,500,000 shares of its common stock (which includes the full exercise of the underwriter's option to purchase 4,891,304 shares to cover overallotments), at a price to the public of $0.92 per share. The Company received net proceeds from this offering, after deducting underwriting discounts, commissions and expenses of $32,069.

On April 14, 2015, the Company provided written notice of termination of the Purchase Agreement pursuant to the terms of the agreement. The termination became effective on April 16, 2015. (See Note 7)

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Government Grants (Details) (USD $) In Thousands, unless otherwise specified	3 Months Ended		6 Months Ended
	Mar. 31, 2015	Mar. 31, 2014	Mar. 31, 2015	Mar. 31, 2014
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	0	57	0	98
Glucagon formulation grant expenses incurred	0	150	0	206
Grant income	$ 0	$ 207	$ 0	$ 304

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Fair Value of Financial Instruments (Details) (USD $) In Thousands, unless otherwise specified	Mar. 31, 2015	Sep. 30, 2014
Liabilities:
Common stock warrant liability (see Note 7)	$ (302)	$ (1,014)
Recurring [Member]
Assets:
Cash and cash equivalents	17,753	24,588
Subtotal	17,753	24,588
Liabilities:
Common stock warrant liability (see Note 7)	(302)	(1,014)
Subtotal	(302)	(1,014)
Total	17,451	23,574
Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member]
Assets:
Cash and cash equivalents	17,753	24,588
Subtotal	17,753	24,588
Liabilities:
Common stock warrant liability (see Note 7)
Subtotal
Total	17,753	24,588
Recurring [Member] | Significant Other Observable Market Inputs (Level 2) [Member]
Assets:
Cash and cash equivalents
Subtotal
Liabilities:
Common stock warrant liability (see Note 7)
Subtotal
Total
Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member]
Assets:
Cash and cash equivalents
Subtotal
Liabilities:
Common stock warrant liability (see Note 7)	(302)	(1,014)
Subtotal	(302)	(1,014)
Total	$ (302)	$ (1,014)

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Stock-Based Compensation (Details 3) (Restricted stock units (RSUs) [Member], USD $)	6 Months Ended
	Mar. 31, 2015
Restricted stock units (RSUs) [Member]
Summary of RSUs activities
Non-vested and outstanding balance
Non-vested and outstanding balance, Weighted average grant date fair value
Changes during the period:
RSUs granted, Shares	131,128
RSUs granted, Weighted average grant date fair value	$ 1.57
RSUs converted to common stock, Shares
RSUs converted to common stock, Weighted average grant date fair value
Subtotal, Share	131,128
Subtotal, Weighted average grant date fair value	$ 1.57
Vested and not distributed, shares
Vested and not distributed, weighted average grant date fair value
Non-vested and outstanding balance	131,128
Non-vested and outstanding balance, Weighted average grant date fair value	$ 1.57

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Condensed Consolidated Statements of Stockholders' Equity (USD $) In Thousands, except Share data	Total	Common Stock $.01 Par Value	Series B Preferred stock $.01 Par Value	Additional Paid in Capital	Accumulated Deficit
Balance at Sep. 30, 2014	$ 22,795	$ 231	$ 19	$ 252,104	$ (229,559)
Balance (in shares) at Sep. 30, 2014		23,079,543	1,950,000
Fees associated with April 2015 offering	(100)			(100)
Proceeds from ATM facility	1,591	10		1,581
Proceeds from ATM facility, Shares		1,042,714
Proceeds from equity line	672	5		667
Proceeds from equity line (in shares)		450,000
Preferred stock conversion
Preferred stock conversion (in shares)		40,590	(40,590)
Stock-based compensation	425			425
Proceeds from the sale of stock-ESPP	10			10
Proceeds from the sale of stock-ESPP (in shares)		7,475
Net loss	(9,043)				(9,043)
Balance at Mar. 31, 2015	$ 16,350	$ 246	$ 19	$ 254,687	$ (238,602)
Balance (in shares) at Mar. 31, 2015		24,620,322	1,909,410

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Stock-Based Compensation

6 Months Ended

Mar. 31, 2015

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 stock price 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 compensation cost related to options for the three and six months ended March 31, 2015 was $180 and $341, respectively. In comparison, the total compensation cost related to options for the three and six months ended March 31, 2014 was $214 and $455, respectively.

At March 31, 2015, the total compensation cost related to non-vested options not yet recognized was $1,714, which will be recognized over the next five years assuming the employees complete their service period for vesting of the options.

The following table summarizes the stock option activity during the six months ended March 31, 2015:

	Number			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Outstanding options, September 30, 2014		2,643,523		$	13.15		5	$	—
Granted		906,750			1.39		7		—
Forfeited, expired		(39,957	)		50.52				—
Outstanding options, March 31, 2015		3,510,316		$	9.69		5		—
Exercisable options, March 31, 2015		1,551,819		$	19.55		3	$	—

The Black-Scholes pricing model assumptions for the three and six months ended March 31, 2014 and 2015 are determined as discussed below:

	Three Months Ended March 31,						Six Months Ended March 31,
	2014			2015			2014			2015
Expected life (in years)		3.77-4.75			3.77-4.75			3.77-4.75			3.77 - 4.75
Expected volatility		73-83	%		62-82	%		70 - 83	%		62 - 82	%
Expected dividend yield		0	%		0	%		0	%		0	%
Risk-free interest rate		0.69 - 0.78	%		0.99 - 1.37	%		0.58 - 0.78	%		0.96 - 1.62	%
Weighted average grant date fair value	$	3.35		$	1.39		$	2.41		$	1.39

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 10%. 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 March 31,				Six Months Ended March 31,
		2014		2015		2014		2015
Stock compensation expense — RSUs	$	—	$	50	$	54	$	84

The following table summarizes RSU activity from October 1, 2014 through March 31, 2015:

	Shares		Weighted Average Grant-Date Fair Value
Non-vested and outstanding balance at October 1, 2014		—	$	—
Changes during the period:
RSUs granted		131,128		1.57
RSUs converted to common stock		—		—
Subtotal		131,128		1.57
Vested and not distributed		—		—
Non-vested and outstanding RSU balance at March 31, 2015		131,128	$	1.57

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 to be 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 and six months ended March 31, 2015 was $1 and $4, respectively. In comparison, for the three and six months ended March 31, 2014, the Company expensed $2 and $1, respectively.

An aggregate of 525,000 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 March 31, 2014 and 2015, a total of 386,880 and 401,262 shares, respectively, were reserved and available for issuance under the Purchase Plan. As of March 31, 2014 and 2015, the Company has issued 113,120 and 123,738 shares, respectively, under the Purchase Plan.

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Stock-Based Compensation (Details Textual) (USD $) In Thousands, except Share data, unless otherwise specified	3 Months Ended		6 Months Ended
	Mar. 31, 2015	Mar. 31, 2014	Mar. 31, 2015	Mar. 31, 2014
Stock-Based Compensation (Textual)
Compensation cost related to employees and directors	$ 180	$ 214	$ 341	$ 455
Total compensation cost related to non-vested options not yet recognized	1,714		1,714
2010 Stock Incentive Plan [Member]
Stock-Based Compensation (Textual)
Vesting period			5 years
Contractual life of option granted			7 years
2010 Restricted Stock Units [Member]
Stock-Based Compensation (Textual)
Annual forfeiture rate for employee			10.00%
2005 Employee Stock Purchase Plan [Member]
Stock-Based Compensation (Textual)
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	$ 2	$ 4	$ 1
Common stock reserved for issuance pursuant to purchase rights to be granted	525,000		525,000
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			401,262	386,880
Total shares issued under purchase plan			123,738	113,120

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Financings (Tables)

6 Months Ended

Mar. 31, 2015

Class of Warrant or Right [Line Items]

Fair value assumptions used in accounting for warrant liability

June 2012 Financing	March 31, 2015
Stock price	$	1.19
Exercise price	$	2.66
Risk-free interest rate		0.56	%
Expected remaining term (years)		2.24
Expected volatility		58	%
Pidend yield		—
Warrants outstanding		2,749,469

May 2011 Offering	March 31, 2015
Stock price	$	1.19
Exercise price	$	9.92
Risk-free interest rate		0.26	%
Expected remaining term (years)		1.13
Expected volatility		41	%
Pidend 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, 2014	$	20
Decrease in fair value of common stock warrant liability		(20	)
Balance at March 31, 2015	$	—

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, 2014	994
Decrease in fair value of common stock warrant liability	(692	)
Balance at March 31, 2015	302