Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Jun. 30, 2017 | Aug. 11, 2017 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Oncobiologics, Inc. | |
Entity Central Index Key | 1,649,989 | |
Trading Symbol | ons | |
Current Fiscal Year End Date | --09-30 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 24,676,365 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2017 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
Consolidated Balance Sheets (un
Consolidated Balance Sheets (unaudited) - USD ($) | Jun. 30, 2017 | Sep. 30, 2016 |
Current assets: | ||
Cash | $ 139,898 | $ 2,351,887 |
Prepaid and other current assets | 1,048,017 | 3,326,607 |
Total current assets | 1,187,915 | 5,678,494 |
Property and equipment, net | 15,137,950 | 16,958,553 |
Restricted cash | 216,086 | |
Other assets | 801,197 | 852,801 |
Total assets | 17,127,062 | 23,705,934 |
Current liabilities: | ||
Senior secured notes | 11,527,154 | |
Current portion of debt | 50,806 | 586,454 |
Current portion of capital lease obligations | 595,500 | 977,248 |
Current portion of stockholder notes | 4,612,500 | 4,612,500 |
Accounts payable | 11,792,280 | 5,071,520 |
Accrued expenses | 7,622,626 | 6,121,942 |
Income taxes payable | 1,854,629 | 1,854,629 |
Deferred revenue | 1,212,561 | 1,212,561 |
Total current liabilities | 39,268,056 | 20,436,854 |
Long-term debt | 164,953 | 2,233,803 |
Capital lease obligations | 34,691 | 320,737 |
Warrant liability | 1,457,026 | |
Deferred revenue | 4,243,963 | 5,153,384 |
Other liabilities | 899,907 | 761,334 |
Total liabilities | 46,068,596 | 28,906,112 |
Stockholders' equity (deficit): | ||
Series A preferred stock, par value $0.01 per share: 10,000,000 shares authorized, no shares issued and outstanding | ||
Common stock, par value $0.01 per share; 200,000,000 shares authorized; 24,659,052 and 22,802,778 shares issued and outstanding at June 30, 2017 and September 30, 2016, respectively | 246,591 | 228,028 |
Additional paid-in capital | 150,675,939 | 141,965,342 |
Accumulated deficit | (179,864,064) | (147,393,548) |
Total stockholders' deficit | (28,941,534) | (5,200,178) |
Total liabilities and stockholders' equity (deficit) | $ 17,127,062 | $ 23,705,934 |
Consolidated Balance Sheets (u3
Consolidated Balance Sheets (unaudited) (Parentheticals) - $ / shares | Jun. 30, 2017 | Sep. 30, 2016 |
Statement of Financial Position [Abstract] | ||
Series A preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Series A preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Series A preferred stock, shares issued | 0 | 0 |
Series A preferred stock outstanding | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 24,659,052 | 22,802,778 |
Common stock, shares outstanding | 24,659,052 | 22,802,778 |
Consolidated Statements of Oper
Consolidated Statements of Operations (unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Income Statement [Abstract] | ||||
Collaboration revenues | $ 303,140 | $ 494,894 | $ 909,421 | $ 2,484,682 |
Operating expenses: | ||||
Research and development | 4,239,615 | 12,017,724 | 21,750,696 | 28,889,977 |
General and administrative | 3,502,719 | 10,504,663 | 12,436,720 | 14,989,380 |
Operating expenses, total | 7,742,334 | 22,522,387 | 34,187,416 | 43,879,357 |
Loss from operations | (7,439,194) | (22,027,493) | (33,277,995) | (41,394,675) |
Interest expense, net | 1,638,302 | 299,439 | 3,164,918 | 1,236,349 |
Change in fair value of warrant liability | (3,750,578) | (3,976,397) | ||
Loss before income taxes | (5,326,918) | (22,326,932) | (32,466,516) | (42,631,024) |
Income tax expense | 500 | 4,000 | 103,000 | |
Net loss | (5,326,918) | (22,327,432) | (32,470,516) | (42,734,024) |
Accretion of redeemable preferred stock and noncontrolling interests | (493,207) | (2,463,160) | ||
Deemed dividend upon issuance of warrants to common stockholders | (7,373,820) | (7,373,820) | ||
Net loss attributable to common stockholders | $ (5,326,918) | $ (30,194,459) | $ (32,470,516) | $ (52,571,004) |
Per share information: | ||||
Net loss per share of common stock, basic (in dollars per share) | $ (0.22) | $ (1.60) | $ (1.36) | $ (3.43) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.22) | $ (1.60) | $ (1.53) | $ (3.43) |
Weighted average shares outstanding, basic (in shares) | 24,442,056 | 18,816,708 | 23,788,046 | 15,336,117 |
Weighted average shares outstanding, diluted (in shares) | 24,442,056 | 18,816,708 | 23,813,910 | 15,336,117 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Deficit) (unaudited) - 9 months ended Jun. 30, 2017 - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2016 | $ 228,028 | $ 141,965,342 | $ (147,393,548) | $ (5,200,178) |
Balance (in shares) at Sep. 30, 2016 | 22,802,778 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Proceeds from exercise of common stock warrants | $ 5,121 | 308,364 | 313,485 | |
Proceeds from exercise of common stock warrants (in shares) | 512,126 | |||
Issuance of vested restricted stock units | $ 4,840 | (4,840) | ||
Issuance of vested restricted stock units (in shares) | 483,913 | |||
Issuance of common stock in connection with equity facility | $ 1,224 | (1,224) | ||
Issuance of common stock in connection with equity facility (in shares) | 122,418 | |||
Sale of common stock, net of issuance costs | $ 7,378 | 1,495,750 | 1,503,128 | |
Sale of common stock, net of issuance costs (in shares) | 737,817 | |||
Stock-based compensation expense | 6,912,547 | 6,912,547 | ||
Net loss | (32,470,516) | (32,470,516) | ||
Balance at Jun. 30, 2017 | $ 246,591 | $ 150,675,939 | $ (179,864,064) | $ (28,941,534) |
Balance (in shares) at Jun. 30, 2017 | 24,659,052 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) | 9 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
OPERATING ACTIVITIES | ||
Net loss | $ (32,470,516) | $ (42,734,024) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,022,028 | 1,790,690 |
Non-cash interest expense | 2,310,096 | 8,594 |
Stock-based compensation | 6,912,547 | 8,618,150 |
Change in fair value of warrant liability | (3,976,397) | |
Loss on disposal of fixed assets | 13,647 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 16,330 | |
Prepaid expenses and other current assets | 2,278,590 | 533,761 |
Other assets | 51,604 | 49,260 |
Accounts payable | 6,661,571 | (5,708,893) |
Accrued expenses | 1,396,417 | 3,287,479 |
Income taxes payable | 100,000 | |
Deferred revenue | (909,421) | (1,484,682) |
Other liabilities | 138,573 | 397,330 |
Net cash used in operating activities | (15,584,908) | (35,112,358) |
INVESTING ACTIVITIES | ||
Purchase of property and equipment | (268,106) | (769,769) |
Net cash used in investing activities | (268,106) | (769,769) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of offering costs | 1,607,396 | 16,137,913 |
Proceeds from sale of common stock units in connection with initial public offering and private placement | 37,074,996 | |
Payment of offering costs and common stock issuance costs | (4,622,647) | |
Payment of debt issuance costs | (40,000) | |
Proceeds from subscriptions receivable | 4,280,149 | |
Proceeds from exercise of common stock warrants | 253,289 | |
Proceeds from the sale of senior secured notes and detachable warrants | 15,000,000 | |
Payments of capital leases obligations | (730,024) | (659,403) |
Repayment of debt | (2,665,722) | (551,288) |
Repayment of stockholder notes | (11,601,696) | |
Change in restricted cash | 216,086 | (1,857) |
Proceeds from related party receivable | 783,211 | |
Deconsolidation of Sonnet Biotherapeutics, Inc. | (401,091) | |
Payment of employee tax witholdings related to the vesting of restricted stock | (71,760) | |
Net cash provided by financing activities | 13,641,025 | 40,366,527 |
Net (decrease) increase in cash | (2,211,989) | 4,484,400 |
Cash at beginning of period | 2,351,887 | 9,070,975 |
Cash at end of period | 139,898 | 13,555,375 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 556,299 | 1,500,675 |
Cash paid for income taxes | 3,000 | |
Supplemental schedule of noncash investing activities: | ||
Purchases of property and equipment in accounts payable and accrued expenses | 23,698 | 477,191 |
Supplemental schedule of noncash financing activities: | ||
Accretion of redeemable common stock | 2,463,160 | |
Issuance of common and Series A preferred stock to redeemable preferred stockholders and noncontrolling interests upon reincorporation | 11,894,638 | |
Reclassification of equity classified stock-based compensation | 15,118,584 | |
Issuance of capital lease obligations in connection with purchase of property and equipment | 62,230 | 78,500 |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses | $ 292,367 | $ 18,145 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Jun. 30, 2017 | |
Organization And Description Of Business [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Oncobiologics, Inc. (“Oncobiologics” or the “Company”) was incorporated in New Jersey on January 5, 2010 and started operations in July 2011. In October 2015, the Company reincorporated in Delaware through the merger with and into Oncobiologics, Inc., a newly formed Delaware corporation, with the Delaware corporation surviving the merger. Oncobiologics is a clinical-stage biopharmaceutical company focused on identifying, developing, manufacturing and commercializing complex biosimilar therapeutics in the disease areas of immunology and oncology. The Company has established fully integrated in-house development and manufacturing capabilities that addresses the numerous complex technical and regulatory challenges in developing and commercializing mAb biosimilars. Since inception, the Company has advanced two product candidates into clinical trials: a Phase 3-ready biosimilar to adalimumab (Humira®) and a Phase 3-ready biosimilar to bevacizumab (Avastin®). Additionally, the Company has six preclinical biosimilar product candidates in various stages of development. In May 2016, the Company completed the initial public offering (“IPO”) of its securities by offering 5,833,334 units. Each unit consisted of one share of the Company’s common stock, one-half of a Series A warrant and one-half of a Series B warrant. Each whole Series A warrant entitles the holder to purchase one share of common stock at an initial exercise price of $6.60, subject to adjustment. Each whole Series B warrant entitles the holder to purchase one share of common stock at an initial exercise price of $8.50, subject to adjustment. The IPO price was $6.00 per unit. In addition, the Company also completed a concurrent private placement of an additional 833,332 shares of its common stock, 416,666 Series A warrants and 416,666 Series B warrants, for gross proceeds of approximately $5.0 million. On May 13, 2016, the units began trading on the NASDAQ Global Market. The units separated in accordance with their terms and ceased trading, and on June 13, 2016, the component securities (common stock, Series A warrants and Series B warrants) began trading on the NASDAQ Global Market. As a result of the IPO and the concurrent private placement, the Company received approximately $33.8 million in net proceeds, after deducting discounts and commissions of approximately $2.9 million and offering expenses of approximately $3.3 million payable by the Company. |
Liquidity
Liquidity | 9 Months Ended |
Jun. 30, 2017 | |
Liquidity [Abstract] | |
Liquidity | 2. Liquidity The Company has incurred substantial losses and negative cash flows from operations since its inception and has an accumulated deficit of $179.9 million as of June 30, 2017. The Company has substantial indebtedness that includes $15.0 million of senior secured notes due in December 2017 and $4.6 million in notes payable to stockholders that are payable on demand. There can be no assurance that the holders of the stockholder notes will not exercise their right to demand repayment. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its products currently in development. Management believes that the Company’s existing cash of $0.1 million as of June 30, 2017 and the $2.5 million research and development, licensing and/or marketing arrangements with pharmaceutical companies, potential disposition of some assets, and exploring additional cost reduction opportunities. In July 2017, the Company entered into a binding exclusivity agreement with a third party for a potential strategic transaction to provide funding to support its development programs. While the Company is actively pursuing this transaction, there can be no guarantee that it will be able to enter into a definitive agreement with this party. Additionally, there can be no assurance that these future funding efforts will be successful, and if not successful, the Company may be required to explore all other alternatives. The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to complete revenue-generating partnerships with pharmaceutical companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies, and, ultimately; (v) regulatory approval and market acceptance of the Company’s proposed future products. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2017 and its results of operations for the three and nine months ended June 30, 2017 and 2016 and cash flows for the nine months ended June 30, 2017 and 2016. Operating results for the nine months ended June 30, 2017 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2017. The unaudited interim consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2016 included in the Company’s Annual Report on Form 10-K, as amended to date, filed with the Securities and Exchange Commission (“SEC”), on December 29, 2016. Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Income taxes The Company recorded income tax expense of $0 and $500 for the three months ended June 30, 2017 and 2016, respectively, and $4,000 and $103,000 for the nine months ended June 30, 2017 and 2016, respectively, which is primarily attributable to state and foreign withholding taxes in connection with the Company’s collaboration and licensing agreements. Net loss per share Basic net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock awards using the treasury stock method. The diluted loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended June 30, Nine months ended June 30, 2017 2016 2017 2016 Basic Earnings Per Share Net loss $ (5,326,918 ) $ (30,194,459 ) $ (32,470,516 ) $ (52,571,004 ) Common stock outstanding (weighted average) 24,442,056 18,816,708 23,788,046 15,336,117 Basic net loss per share $ (0.22 ) $ (1.60 ) $ (1.36 ) $ (3.43 ) Diluted Earnings Per Share Net loss (5,326,918 ) (30,194,459 ) (32,470,516 ) (52,571,004 ) Add change in fair value of warrant liability - - (3,976,397 ) - Diluted net loss (5,326,918 ) (30,194,459 ) (36,446,913 ) (52,571,004 ) Common stock outstanding (weighted average) 24,442,056 18,816,708 23,788,046 15,336,117 Add shares from dilutive warrants - - 25,864 - Common stock equivalents 24,442,056 18,816,708 23,813,910 15,336,117 Diluted net loss per share $ (0.22 ) $ (1.60 ) $ (1.53 ) $ (3.43 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2017 and 2016, as they would be antidilutive: June 30, 2017 2016 Performance-based stock units 214,413 247,598 Restricted stock units 1,068,260 1,096,171 Common stock warrants 7,760,988 8,186,935 Recently issued and adopted accounting pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers Contracts with customers Significant judgments and changes in judgments Certain assets In July 2015, the FASB delayed the effective date of this guidance. As a result, this guidance will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. The Company is currently evaluating the impact that this guidance will have on its consolidated results of operations, financial position and cash flows. In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU No. 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ■ Level 1 — Quoted prices in active markets for identical assets or liabilities. ■ Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, 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 determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis: June 30, 2017 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ - $ - $ 1,457,026 The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability for the nine months ended June 30, 2017: Balance at October 1, 2016 $ - Issuance of warrants 5,493,619 Exercise of warrants (60,196 ) Change in fair value (3,976,397 ) Balance at June 30, 2017 $ 1,457,026 The warrants issued in connection with the senior secured notes are classified as liabilities on the accompanying consolidated balance sheet as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair value of the warrant liability is estimated using the Black-Scholes option pricing model using the following assumptions: June 30, 2017 Risk-free interest rate 1.66% Remaining contractual life of warrant 4.61 years Expected volatility 82% Annual dividend yield 0% Fair value of common stock $1.00 per share |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Jun. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net, consists of: June 30, September 30, 2017 2016 Laboratory equipment $ 11,574,474 $ 11,452,858 Leasehold improvements 10,032,640 10,031,739 Computer software and hardware 471,152 421,206 Construction in progress 1,034,552 1,014,690 23,112,818 22,920,493 Less: accumulated depreciation and amortization (7,974,868 ) (5,961,940 ) $ 15,137,950 $ 16,958,553 Depreciation and amortization expense was $672,098 and $598,615 for the three months ended June 30, 2017 and 2016, respectively, and $2,022,028 and $1,790,690 for the nine months ended June 30, 2017 and 2016, respectively. At June 30, 2017 and September 30, 2016, $3,692,913 and $3,630,683, respectively, represents laboratory equipment under capital leases. The term of the leases are between 22 and 36 months and qualify as capital leases. The leases bear interest between 5.0% and 19.4%. At June 30, 2017 and September 30, 2016, $976,581 and $732,002, respectively, of accumulated amortization related to this leased equipment has been recognized. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Jun. 30, 2017 | |
Accrued Expenses [Abstract] | |
Accrued expenses | 6. Accrued Expenses Accrued expenses consists of: June 30, September 30, 2017 2016 Compensation $ 4,518,254 $ 3,884,386 Research and development 1,784,030 1,343,910 Interest payable 783,210 234,754 Deferred offering costs - 26,028 Professional fees 160,743 486,705 Director fees 292,500 73,125 Other accrued expenses 83,889 73,034 $ 7,622,626 $ 6,121,942 |
Senior Secured Notes
Senior Secured Notes | 9 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Senior Secured Notes | 7. Senior Secured Notes June 30, 2017 Senior secured notes $ 15,000,000 Unamortized debt discount (3,472,846 ) $ 11,527,154 In October, November and December 2016, the Company issued $1.85 million aggregate principal amount of unsecured bridge notes to accredited investors. These unsecured notes bore interest at a rate of 15% per year and had a one-year maturity date from the date of issuance. These unsecured notes were exchanged for senior secured promissory notes in December 2016 as described below. On December 22, 2016, the Company entered into a Note and Warrant Purchase Agreement (the “NWPA”) with accredited investors providing for the issuance and sale of up to $10.0 million of senior secured promissory notes (the “Notes”), which bear interest at a rate of 5% per year and mature December 22, 2017 and warrants (the “Warrants”) to acquire an aggregate 2.3 million shares of the Company’s common stock at an exercise price of $3.00 per share, which have a five-year term. The Company closed the initial sale and purchase of the Notes and Warrants on December 22, 2016, issuing $8.35 million aggregate principal amount of Notes and Warrants to acquire up to 1,920,500 shares of the Company’s common stock in exchange for $6.5 million of cash and an aggregate of $1.85 million of existing unsecured bridge notes issued by the Company in October, November and December 2016. The proceeds were first allocated to the warrant liability based on their initial fair value of $3.3 million with a corresponding amount recorded as a debt discount. In addition, the Company incurred $40,000 of debt issuance costs that have been recorded as a debt discount. The debt discount is being amortized into interest expense over the term of the Notes. The Company used $2.4 million of the proceeds from the sale of the Notes to pay off its remaining senior secured bank loans, and will use the remainder for working capital purposes. In January 2017, the Company issued the remaining Notes and Warrants for $1.65 million of cash. On April 13, 2017, the Company entered into the First Amendment to the NWPA (the “Amendment”) with the required holders of its Notes named therein, to amend certain terms of the NWPA. The primary purpose of the Amendment was to increase the aggregate principal amount of Notes that may be sold under the NWPA from $10.0 million to $15.0 million, and permit the issuance of additional Warrants to acquire an aggregate 1,665,000 shares of the Company’s common stock and extend the time that the Company may issue additional Notes and Warrants without approval of the holders of existing notes from 90 days to 180 days. Notes sold under the Amendment will bear interest at a rate of 5% per annum and mature December 2017 (12 months from the date of the NWPA). During April and May 2017, the Company issued an additional $5.0 million of Notes and Warrants to acquire an aggregate of 1,304,500 shares of its common stock. The proceeds were first allocated to the warrant liability based on their initial fair value of $1.4 million with a corresponding amount recorded as a debt discount. In addition, the Company incurred $3,635 of debt issuance costs that have been recorded as a debt discount. The debt discount is being amortized into interest expense over the term of the Notes. Under the NWPA and the Amendment, the Company agreed to customary negative covenants restricting its ability to repay indebtedness to officers, pay dividends to stockholders, repay or incur other indebtedness other than as permitted, grant or suffer to exist a security interest in any of the Company’s assets, other than as permitted, or enter into any transactions with affiliates. In addition to the negative covenants in the NWPA, the Notes include customary events of default. In connection with the closing of the initial sale of the Notes and Warrants, the Company entered into a Security Agreement and an Intellectual Property Security Agreement, each dated December 22, 2016, granting the holders of the Notes a security interest in all of its assets, as well as a Registration Rights Agreement dated February 3, 2017. Interest expense on the Notes for the three and nine months ended June 30, 2017 was $1,500,500 and $2,548,428, respectively. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 9 Months Ended |
Jun. 30, 2017 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity (Deficit) | 8. Stockholders’ Equity (Deficit) Lincoln Park Capital, LLC transaction On March 8, 2017, the Company entered into a Purchase Agreement and a Registration Rights Agreement with an accredited investor, Lincoln Park Capital, LLC (“Lincoln Park”), providing for the purchase of up to $15.4 million of the Company’s common stock over the 30-month term of the Purchase Agreement. In connection with the Purchase Agreement, the Company issued 113,205 shares of its common stock as initial commitment shares, to Lincoln Park and the Company will issue, pro rata, up to an additional 113,206 shares of its common stock as additional commitment shares to Lincoln Park in connection with any additional purchases. Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to an additional $15.0 million worth of shares of the Company’s common stock. As contemplated by the Purchase Agreement, and so long as the closing price of the Company’s common stock exceeds $1.50 per share, the Company may direct Lincoln Park, at the Company’s sole discretion to purchase up to 30,000 shares of its common stock on any business day. The price per share for such purchases will be equal to the lower of: (i) the lowest sale price on the applicable purchase date and (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive business days ending on the business day immediately preceding such purchase date (in each case, to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction that occurs on or after the date of the Purchase Agreement). The maximum amount of shares subject to any single regular purchase increases as the Company’s share price increases, subject to a maximum of $1.0 million. In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the Purchase Agreement if it would result in Lincoln Park beneficially owning more than 4.99% of its common stock. There are neither trading volume requirements nor restrictions under the Purchase Agreement nor upper limits on the price per share that Lincoln Park must pay for shares of common stock. The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any “event of default” under the Purchase Agreement, all of which are outside of Lincoln Park’s control, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such event of default is cured. In addition, in the event of bankruptcy proceedings by or against the Company, the Purchase Agreement will automatically terminate. During the nine months ended June 30, 2017, the Company sold 737,817 shares of common stock to Lincoln Park for $1,620,931, and incurred $117,540 of issuance costs. In addition, the Company issued 122,418 shares of common stock to Lincoln Park as commitment shares pursuant to the Purchase Agreement. Common stock warrants As of June 30, 2017, the Company had the following warrants outstanding to acquire shares of its common stock: Outstanding Exercise Expiration Series A warrants 3,333,333 $ 6.60 February 18, 2018 Series B warrants 3,333,333 $ 8.50 May 18, 2018 Common stock warrants issued with IPO 1,094,322 $ 0.01 November 11, 2019 Common stock warrants issued with senior secured notes 3,521,501 $ 3.00 December 22, 2021 11,282,489 During the nine months ended June 30, 2017, warrants to purchase 429,127 and 82,999 shares with exercise prices of $0.01 and $3.00 per share respectively, were exercised. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Jun. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based compensation | 9. Stock-Based Compensation 2011 Equity Incentive Plan The Company’s 2011 Equity Compensation Plan (the “2011 Plan”) provided for the Company to sell or issue restricted common stock, restricted stock units (“RSUs”), performance-based awards, cash-based awards or to grant stock options for the purchase of common stock to officers, employees, consultants and directors of the Company. The 2011 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board. The number of shares of common stock reserved for issuance under the 2011 Plan is 1,159,420. As of June 30, 2017, performance-based stock unit awards (“PSUs”) representing 214,413 shares of the Company’s common stock were outstanding under the 2011 Plan. In light of the December 2015 adoption of the 2015 Equity Incentive Plan, no future awards under the 2011 Plan will be granted. 2015 Equity Incentive Plan In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The maximum number of shares of common stock that may be issued under the 2015 Plan is 2,638,101 shares. As of June 30, 2017, RSUs representing 1,068,260 shares of the Company’s common stock were outstanding under the 2015 Plan and 1,085,928 shares remained available for grant under the 2015 Plan. The Company recorded stock-based compensation expense in the following expense categories of its statements of operations for the three and nine months ended June 30, 2017 and 2016: Three months ended June 30, Nine Months ended June 30, 2017 2016 2017 2016 Research and development $ 205,104 $ 3,771,214 $ 1,022,919 $ 1,846,408 General and administrative 1,916,000 6,803,391 5,889,628 6,771,742 $ 2,121,104 $ 10,574,605 $ 6,912,547 $ 8,618,150 Three months ended June 30, Nine Months ended June 30, 2017 2016 2017 2016 Equity-classified compensation $ 2,121,104 $ 10,574,605 $ 6,912,547 $ 6,226,288 Liability-classified compensation - - - 2,391,862 $ 2,121,104 $ 10,574,605 $ 6,912,547 $ 8,618,150 Performance-based stock units The Company has issued PSUs, which generally have a ten year life from the date of grant and vest 50% after the third anniversary from issuance and the remaining 50% on the fourth anniversary. The PSUs are exercisable upon the earlier of (i) a change in control, (ii) consummation of an initial public offering, or (iii) a corporate valuation in excess of $400 million. Upon exercise, the PSU holder receives common stock or cash at the Company’s discretion. The following table summarizes the PSU activity for the nine months ended June 30, 2017: Number Base of Price PSUs Per PSU Balance at October 1, 2016 247,309 $ 6.33 Forfeitures (32,896 ) 6.49 Balance at June 30, 2017 214,413 $ 6.30 As of June 30, 2017, there was $288,270 of unamortized expense that will be recognized over a weighted-average period of 1.05 years. Restricted stock units The following table summarizes the activity related to RSUs during the nine months ended June 30, 2017: Weighted Number Average of Grant Date RSUs Fair Value Balance at October 1, 2016 1,094,351 $ 28.61 Granted 615,000 2.11 Vested and settled (483,913 ) 29.05 Forfeitures (157,178 ) 3.69 Balance at June 30, 2017 1,068,260 $ 16.82 The Company has granted RSUs that generally vest over a period of two to four years from the date of grant. In addition, vesting of the RSUs was also dependent upon the closing of the Company’s IPO, which is a performance condition that is outside the Company’s control. Therefore, the Company did not recognize any stock-based compensation until the consummation of the IPO in May 2016. As of June 30, 2017, there was $6,453,949 of unamortized expense that will be recognized over a weighted-average period of 1.04 years. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events Exclusivity and strategic licensing agreement On July 25, 2017, the Company entered into a binding exclusivity agreement with a third party. Under the exclusivity agreement, the Company agreed not to pursue any alternative transactions (broadly defined to encompass most equity and debt financing transactions, as well as acquisitions), subject to certain limited exceptions, for a period of 75 days (which may be extended for two 20-day periods). There is no guarantee that the Company will enter into any definitive agreements with the third party. In the event the Company and the third party do not enter into a binding transaction but the Company enters into an alternative transaction within three months following termination of the exclusivity agreement, the Company agreed to pay the third party a break-up fee of $7.5 million. On the same date, the Company also entered into a strategic licensing agreement with the same third party, under which it granted the third party and its affiliates a perpetual, irrevocable, exclusive, sublicensable license in the agreed territory for the research, development, manufacture, use or sale of the ONS-1045 biosimilar product candidate in the agreed territory. The agreed territory includes all emerging markets but specifically excludes major developed markets, such as the United States, Canada, Europe, Japan, Australia and New Zealand, and smaller markets where the Company has existing licensing arrangements, such as Mexico, greater China and India. Under the terms of the strategic licensing agreement, the Company received an initial upfront payment from the third party of $1.25 million, and an additional $1.25 million upon meeting a notice and acknowledgment milestone |
Basis of Presentation and Sum17
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2017 and its results of operations for the three and nine months ended June 30, 2017 and 2016 and cash flows for the nine months ended June 30, 2017 and 2016. Operating results for the nine months ended June 30, 2017 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2017. The unaudited interim consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2016 included in the Company’s Annual Report on Form 10-K, as amended to date, filed with the Securities and Exchange Commission (“SEC”), on December 29, 2016. |
Use of estimates | Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. |
Income taxes | Income taxes The Company recorded income tax expense of $0 and $500 for the three months ended June 30, 2017 and 2016, respectively, and $4,000 and $103,000 for the nine months ended June 30, 2017 and 2016, respectively, which is primarily attributable to state and foreign withholding taxes in connection with the Company’s collaboration and licensing agreements. |
Net loss per share | Net loss per share Basic net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock awards using the treasury stock method. The diluted loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended June 30, Nine months ended June 30, 2017 2016 2017 2016 Basic Earnings Per Share Net loss $ (5,326,918 ) $ (30,194,459 ) $ (32,470,516 ) $ (52,571,004 ) Common stock outstanding (weighted average) 24,442,056 18,816,708 23,788,046 15,336,117 Basic net loss per share $ (0.22 ) $ (1.60 ) $ (1.36 ) $ (3.43 ) Diluted Earnings Per Share Net loss (5,326,918 ) (30,194,459 ) (32,470,516 ) (52,571,004 ) Add change in fair value of warrant liability - - (3,976,397 ) - Diluted net loss (5,326,918 ) (30,194,459 ) (36,446,913 ) (52,571,004 ) Common stock outstanding (weighted average) 24,442,056 18,816,708 23,788,046 15,336,117 Add shares from dilutive warrants - - 25,864 - Common stock equivalents 24,442,056 18,816,708 23,813,910 15,336,117 Diluted net loss per share $ (0.22 ) $ (1.60 ) $ (1.53 ) $ (3.43 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2017 and 2016, as they would be antidilutive: June 30, 2017 2016 Performance-based stock units 214,413 247,598 Restricted stock units 1,068,260 1,096,171 Common stock warrants 7,760,988 8,186,935 |
Recently Issued and Adopted Accounting Pronouncements | Recently issued and adopted accounting pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers Contracts with customers Significant judgments and changes in judgments Certain assets In July 2015, the FASB delayed the effective date of this guidance. As a result, this guidance will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. The Company is currently evaluating the impact that this guidance will have on its consolidated results of operations, financial position and cash flows. In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU No. 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting |
Basis of Presentation and Sum18
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Schedule of computation of basic earnings per share and diluted earnings per share | Three months ended June 30, Nine months ended June 30, 2017 2016 2017 2016 Basic Earnings Per Share Net loss $ (5,326,918 ) $ (30,194,459 ) $ (32,470,516 ) $ (52,571,004 ) Common stock outstanding (weighted average) 24,442,056 18,816,708 23,788,046 15,336,117 Basic net loss per share $ (0.22 ) $ (1.60 ) $ (1.36 ) $ (3.43 ) Diluted Earnings Per Share Net loss (5,326,918 ) (30,194,459 ) (32,470,516 ) (52,571,004 ) Add change in fair value of warrant liability - - (3,976,397 ) - Diluted net loss (5,326,918 ) (30,194,459 ) (36,446,913 ) (52,571,004 ) Common stock outstanding (weighted average) 24,442,056 18,816,708 23,788,046 15,336,117 Add shares from dilutive warrants - - 25,864 - Common stock equivalents 24,442,056 18,816,708 23,813,910 15,336,117 Diluted net loss per share $ (0.22 ) $ (1.60 ) $ (1.53 ) $ (3.43 ) |
Schedule of dilutive securities excluded from the computation weighted-average shares | June 30, 2017 2016 Performance-based stock units 214,413 247,598 Restricted stock units 1,068,260 1,096,171 Common stock warrants 7,760,988 8,186,935 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | June 30, 2017 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ - $ - $ 1,457,026 |
Summary of changes in the fair value of the Company's Level 3 valuation for the warrant liability | Balance at October 1, 2016 $ - Issuance of warrants 5,493,619 Exercise of warrants (60,196 ) Change in fair value (3,976,397 ) Balance at June 30, 2017 $ 1,457,026 |
Schedule of fair value of the performance-based stock units (PSUs) | June 30, 2017 Risk-free interest rate 1.66% Remaining contractual life of warrant 4.61 years Expected volatility 82% Annual dividend yield 0% Fair value of common stock $1.00 per share |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | June 30, September 30, 2017 2016 Laboratory equipment $ 11,574,474 $ 11,452,858 Leasehold improvements 10,032,640 10,031,739 Computer software and hardware 471,152 421,206 Construction in progress 1,034,552 1,014,690 23,112,818 22,920,493 Less: accumulated depreciation and amortization (7,974,868 ) (5,961,940 ) $ 15,137,950 $ 16,958,553 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Accrued Expenses [Abstract] | |
Schedule of accrued expenses | June 30, September 30, 2017 2016 Compensation $ 4,518,254 $ 3,884,386 Research and development 1,784,030 1,343,910 Interest payable 783,210 234,754 Deferred offering costs - 26,028 Professional fees 160,743 486,705 Director fees 292,500 73,125 Other accrued expenses 83,889 73,034 $ 7,622,626 $ 6,121,942 |
Senior Secured Notes (Tables)
Senior Secured Notes (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of senior secured note | June 30, 2017 Senior secured notes $ 15,000,000 Unamortized debt discount (3,472,846 ) $ 11,527,154 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Stockholders' Equity Note [Abstract] | |
Schedule of warrants outstanding | Outstanding Exercise Expiration Series A warrants 3,333,333 $ 6.60 February 18, 2018 Series B warrants 3,333,333 $ 8.50 May 18, 2018 Common stock warrants issued with IPO 1,094,322 $ 0.01 November 11, 2019 Common stock warrants issued with senior secured notes 3,521,501 $ 3.00 December 22, 2021 11,282,489 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of stock-based compensation expense | Three months ended June 30, Nine Months ended June 30, 2017 2016 2017 2016 Research and development $ 205,104 $ 3,771,214 $ 1,022,919 $ 1,846,408 General and administrative 1,916,000 6,803,391 5,889,628 6,771,742 $ 2,121,104 $ 10,574,605 $ 6,912,547 $ 8,618,150 Three months ended June 30, Nine Months ended June 30, 2017 2016 2017 2016 Equity-classified compensation $ 2,121,104 $ 10,574,605 $ 6,912,547 $ 6,226,288 Liability-classified compensation - - - 2,391,862 $ 2,121,104 $ 10,574,605 $ 6,912,547 $ 8,618,150 |
Schedule of performance-based stock units activity | Number Base of Price PSUs Per PSU Balance at October 1, 2016 247,309 $ 6.33 Forfeitures (32,896 ) 6.49 Balance at June 30, 2017 214,413 $ 6.30 |
Schedule of restricted stock units activity | Weighted Number Average of Grant Date RSUs Fair Value Balance at October 1, 2016 1,094,351 $ 28.61 Granted 615,000 2.11 Vested and settled (483,913 ) 29.05 Forfeitures (157,178 ) 3.69 Balance at June 30, 2017 1,068,260 $ 16.82 |
Organization and Description 25
Organization and Description of Business (Detail Textuals) - USD ($) | May 13, 2016 | May 31, 2016 | Jun. 30, 2017 | Jun. 30, 2016 |
Organization And Description Of Business [Line Items] | ||||
Proceeds from sale of common stock units in connection with initial public offering and private placement | $ 37,074,996 | |||
Common stock repurchase note | ||||
Organization And Description Of Business [Line Items] | ||||
Common stock share issued | 737,817 | |||
Series A warrant | ||||
Organization And Description Of Business [Line Items] | ||||
Exercise price per share | $ 6.6 | |||
Series B warrant | ||||
Organization And Description Of Business [Line Items] | ||||
Exercise price per share | $ 8.5 | |||
IPO | ||||
Organization And Description Of Business [Line Items] | ||||
Description of IPO unit | Each unit consisted of one share of the Company's common stock, one-half of a Series A warrant and one-half of a Series B warrant. | |||
Common stock share issued | 5,833,334 | |||
Initial public offering price per share | $ 6 | |||
Proceeds from sale of common stock units in connection with initial public offering and private placement | $ 33,800,000 | |||
Underwriting discounts and commissions | 2,900,000 | |||
Estimated offering expenses | $ 3,300,000 | |||
IPO | Series A warrant | ||||
Organization And Description Of Business [Line Items] | ||||
Exercise price per share | 6.60 | |||
IPO | Series B warrant | ||||
Organization And Description Of Business [Line Items] | ||||
Exercise price per share | $ 8.50 | |||
Private Placement | ||||
Organization And Description Of Business [Line Items] | ||||
Common stock share issued | 833,332 | |||
Gross proceeds of private placement and warrants | $ 5,000,000 | |||
Private Placement | Series A warrant | ||||
Organization And Description Of Business [Line Items] | ||||
Common stock share issued | 416,666 | |||
Private Placement | Series B warrant | ||||
Organization And Description Of Business [Line Items] | ||||
Common stock share issued | 416,666 |
Liquidity (Detail Textuals)
Liquidity (Detail Textuals) - USD ($) | 1 Months Ended | 9 Months Ended | |||
Aug. 08, 2017 | Jun. 30, 2017 | Sep. 30, 2016 | Jun. 30, 2016 | Sep. 30, 2015 | |
Liquidity [Line Items] | |||||
Accumulated deficit | $ (179,864,064) | $ (147,393,548) | |||
Aggregate indebtedness | 15,000,000 | ||||
Notes payable to stockholders | 4,600,000 | ||||
Cash | 139,898 | $ 2,351,887 | $ 13,555,375 | $ 9,070,975 | |
Proceeds from issuance of notes | $ 15,000,000 | ||||
Subsequent event | |||||
Liquidity [Line Items] | |||||
Proceeds from issuance of notes | $ 2,500,000 |
Basis of Presentation and Sum27
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Basic Earnings Per Share | ||||
Net loss | $ (5,326,918) | $ (30,194,459) | $ (32,470,516) | $ (52,571,004) |
Common stock outstanding (weighted average) | 24,442,056 | 18,816,708 | 23,788,046 | 15,336,117 |
Basic net loss per share | $ (0.22) | $ (1.60) | $ (1.36) | $ (3.43) |
Diluted Earnings Per Share | ||||
Net loss | $ (5,326,918) | $ (30,194,459) | $ (32,470,516) | $ (52,571,004) |
Add change in fair value of warrant liability | (3,750,578) | (3,976,397) | ||
Diluted net loss | $ (5,326,918) | $ (30,194,459) | $ (36,446,913) | $ (52,571,004) |
Common stock outstanding (weighted average) | 24,442,056 | 18,816,708 | 23,788,046 | 15,336,117 |
Add shares from dilutive warrants | 25,864 | |||
Common stock equivalents | 24,442,056 | 18,816,708 | 23,813,910 | 15,336,117 |
Diluted net loss per share (in dollars per share) | $ (0.22) | $ (1.60) | $ (1.53) | $ (3.43) |
Basis of Presentation and Sum28
Basis of Presentation and Summary of Significant Accounting Policies (Details 1) - shares | 9 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Performance-based stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 214,413 | 247,598 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,068,260 | 1,096,171 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 7,760,988 | 8,186,935 |
Basis of Presentation and Sum29
Basis of Presentation and Summary of Significant Accounting Policies (Detail Textuals) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Accounting Policies [Abstract] | ||||
Income tax expense (benefit) attributable to foreign withholding taxes in connection with collaboration and licensing agreements | $ 0 | $ 500 | $ 4,000 | $ 103,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) | Jun. 30, 2017USD ($) |
Liabilities | |
Warrant liability | $ 1,457,026 |
Fair value measurements recurring basis | Level 1 | |
Liabilities | |
Warrant liability | |
Fair value measurements recurring basis | Level 2 | |
Liabilities | |
Warrant liability | |
Fair value measurements recurring basis | Level 3 | |
Liabilities | |
Warrant liability | $ 1,457,026 |
Fair Value Measurements (Deta31
Fair Value Measurements (Details 1) - Warrant | 9 Months Ended |
Jun. 30, 2017USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance at October 1, 2016 | |
Issuance of warrants | 5,493,619 |
Exercise of warrants | (60,196) |
Change in fair value | (3,976,397) |
Balance at June 30, 2017 | $ 1,457,026 |
Fair Value Measurements (Deta32
Fair Value Measurements (Details 2) - Warrant | 9 Months Ended |
Jun. 30, 2017$ / shares | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Risk-free interest rate | 1.66% |
Remaining contractual life of warrant | 4 years 7 months 10 days |
Expected volatility | 82.00% |
Annual dividend yield | 0.00% |
Fair value of common stock | $ 1 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) | Jun. 30, 2017 | Sep. 30, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 23,112,818 | $ 22,920,493 |
Less: accumulated depreciation and amortization | (7,974,868) | (5,961,940) |
Property and equipment, net | 15,137,950 | 16,958,553 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 11,574,474 | 11,452,858 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 10,032,640 | 10,031,739 |
Computer software and hardware | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 471,152 | 421,206 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,034,552 | $ 1,014,690 |
Property and Equipment, Net (34
Property and Equipment, Net (Detail Textuals) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Sep. 30, 2016 | |
Property, Plant and Equipment [Line Items] | |||||
Depreciation and amortization expense | $ 672,098 | $ 598,615 | $ 2,022,028 | $ 1,790,690 | |
Laboratory Equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Laboratory equipment under capital leases | 3,692,913 | 3,692,913 | $ 3,630,683 | ||
Accumulated depreciation related to leased equipment | $ 976,581 | $ 976,581 | $ 732,002 | ||
Laboratory Equipment | Minimum | |||||
Property, Plant and Equipment [Line Items] | |||||
Term of capital leases | 22 months | ||||
Capital leases interest rate | 5.00% | ||||
Laboratory Equipment | Maximum | |||||
Property, Plant and Equipment [Line Items] | |||||
Term of capital leases | 36 months | ||||
Capital leases interest rate | 19.40% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2017 | Sep. 30, 2016 |
Accrued Liabilities, Current [Abstract] | ||
Compensation | $ 4,518,254 | $ 3,884,386 |
Research and development | 1,784,030 | 1,343,910 |
Interest payable | 783,210 | 234,754 |
Deferred offering costs | 26,028 | |
Professional fees | 160,743 | 486,705 |
Director fees | 292,500 | 73,125 |
Other accrued expenses | 83,889 | 73,034 |
Accrued expenses | $ 7,622,626 | $ 6,121,942 |
Senior Secured Notes (Details)
Senior Secured Notes (Details) | Jun. 30, 2017USD ($) |
Debt Instrument [Line Items] | |
Senior secured notes | $ 11,527,154 |
Senior secured notes | |
Debt Instrument [Line Items] | |
Senior secured notes | 15,000,000 |
Unamortized debt discount | (3,472,846) |
Senior secured notes | $ 11,527,154 |
Senior Secured Notes (Detail Te
Senior Secured Notes (Detail Textuals) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jan. 31, 2017 | Dec. 22, 2016 | May 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Apr. 13, 2017 | |
Debt Instrument [Line Items] | ||||||||
Aggregate principal amount of notes and warrants issued | $ 1,650,000 | |||||||
Repayment of senior secured bank loans | $ 2,665,722 | $ 551,288 | ||||||
Interest expense on the notes | $ 1,500,500 | $ 2,548,428 | ||||||
Bridge note | ||||||||
Debt Instrument [Line Items] | ||||||||
Unsecured bridge notes | $ 1,850,000 | |||||||
Interest rate | 15.00% | |||||||
Debt Instrument, term | 1 year | |||||||
Senior note | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate | 5.00% | 5.00% | ||||||
Debt instrument, maturity date | Dec. 22, 2017 | |||||||
Warrants to acquire common stock | 2,300,000 | 1,304,500 | ||||||
Exercise price per share | $ 3 | |||||||
Term of warrants | 5 years | |||||||
Aggregate principal amount of notes and warrants issued | $ 8,350,000 | $ 5,000,000 | ||||||
Maximum number of shares called by warrants | 1,920,500 | 1,665,000 | ||||||
Proceeds from issuance of secured debt | $ 6,500,000 | |||||||
Repayment of senior secured bank loans | 2,400,000 | |||||||
Initial fair value of warrant liability | 3,300,000 | 1,400,000 | ||||||
Debt issuance costs | 40,000 | $ 3,635 | ||||||
Senior note | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Senior secured promissory note | $ 10,000,000 | $ 15,000,000 |
Stockholders' Equity (Deficit38
Stockholders' Equity (Deficit) (Details) | 9 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Outstanding | 11,282,489 |
Series A warrant | |
Class of Warrant or Right [Line Items] | |
Outstanding | 3,333,333 |
Exercise price per share | $ / shares | $ 6.6 |
Expiration date | Feb. 18, 2018 |
Series B warrant | |
Class of Warrant or Right [Line Items] | |
Outstanding | 3,333,333 |
Exercise price per share | $ / shares | $ 8.5 |
Expiration date | May 18, 2018 |
Common stock warrants issued with IPO | |
Class of Warrant or Right [Line Items] | |
Outstanding | 1,094,322 |
Exercise price per share | $ / shares | $ 0.01 |
Expiration date | Nov. 11, 2019 |
Common stock warrants issued with senior secured notes | |
Class of Warrant or Right [Line Items] | |
Outstanding | 3,521,501 |
Exercise price per share | $ / shares | $ 3 |
Expiration date | Dec. 22, 2021 |
Stockholders' Equity (Deficit39
Stockholders' Equity (Deficit) (Detail Textuals) - USD ($) | Mar. 08, 2017 | Jun. 30, 2017 | Jun. 30, 2016 |
Stockholders' Equity (Deficit) [Line Items] | |||
Number of shares issued in cash | $ 1,503,128 | ||
Proceeds from the sale of common stock, net of offering costs | $ 1,607,396 | $ 16,137,913 | |
Lincoln Park | |||
Stockholders' Equity (Deficit) [Line Items] | |||
Purchase of up to shares of common stock | $ 15,400,000 | ||
Additional shares of common stock issued | 122,418 | ||
Closing price | $ 1.50 | ||
Number of shares purchase by sole discretion on any business day | 30,000 | ||
Description of transaction | The price per share for such purchases will be equal to the lower of: (i) the lowest sale price on the applicable purchase date and (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive business days ending on the business day immediately preceding such purchase date (in each case, to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction that occurs on or after the date of the purchase agreement). | ||
Maximum amount of shares purchase increased as increase in share price | $ 1,000,000 | ||
Beneficial ownership percentage | 4.99% | ||
Shares issued during period | 737,817 | ||
Number of shares issued in cash | $ 1,620,931 | ||
Payment for stock issuance cost | $ 117,540 | ||
Additional value of shares obligated to issue | $ 15,000,000 | ||
Lincoln Park | Purchase agreement | |||
Stockholders' Equity (Deficit) [Line Items] | |||
Shares issued during period | 113,205 | ||
Common stock additional commitment shares | 113,206 |
Stockholders' Equity (Deficit40
Stockholders' Equity (Deficit) (Detail Textuals 1) | Jun. 30, 2017$ / sharesshares |
Warrant exercise price 0.01 | |
Class of Warrant or Right [Line Items] | |
Warrants to acquire stock | shares | 429,127 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.01 |
Warrant exercise price 3.00 | |
Class of Warrant or Right [Line Items] | |
Warrants to acquire stock | shares | 82,999 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - 2015 Equity Incentive Plan - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 2,121,104 | $ 10,574,605 | $ 6,912,547 | $ 8,618,150 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 205,104 | 3,771,214 | 1,022,919 | 1,846,408 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,916,000 | $ 6,803,391 | $ 5,889,628 | $ 6,771,742 |
Stock Based Compensation (Det42
Stock Based Compensation (Details 1) - 2015 Equity Incentive Plan - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 2,121,104 | $ 10,574,605 | $ 6,912,547 | $ 8,618,150 |
Equity-classified compensation | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 2,121,104 | 10,574,605 | 6,912,547 | 6,226,288 |
Liability-classified compensation | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 2,391,862 |
Stock Based Compensation (Det43
Stock Based Compensation (Details 2) - Performance-based stock units | 9 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Number of PSUs | |
Balance at October 1, 2016 | shares | 247,309 |
Forfeitures | shares | (32,896) |
Balance at June 30, 2017 | shares | 214,413 |
Base Price Per PSU | |
Balance at October 1, 2016 | $ / shares | $ 6.33 |
Forfeitures | $ / shares | 6.49 |
Balance at June 30, 2017 | $ / shares | $ 6.3 |
Stock Based Compensation (Det44
Stock Based Compensation (Details 3) - Restricted stock units | 9 Months Ended |
Jun. 30, 2016$ / sharesshares | |
Number of RSUs | |
Balance at October 1, 2016 | shares | 1,094,351 |
Granted | shares | 615,000 |
Vested and settled | shares | (483,913) |
Forfeitures | shares | (157,178) |
Balance at June 30, 2017 | shares | 1,068,260 |
Weighted Average Grant Date Fair Value | |
Balance at October 1, 2016 | $ / shares | $ 28.61 |
Granted | $ / shares | 2.11 |
Vested and settled | $ / shares | 29.05 |
Forfeitures | $ / shares | 3.69 |
Balance at June 30, 2017 | $ / shares | $ 16.82 |
Stock Based Compensation (Det45
Stock Based Compensation (Detail Textuals) - 2011 Equity Incentive Plan - Officers, Employees, Consultants and Directors | Jun. 30, 2017shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares of common stock reserved for issuance | 1,159,420 |
Number of common stock outstanding under the Plan | 214,413 |
Stock Based Compensation (Det46
Stock Based Compensation (Detail Textuals 1) - shares | Jun. 30, 2017 | Jun. 30, 2016 | Sep. 30, 2015 |
Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares outstanding under the Plan | 1,068,260 | 1,094,351 | |
2015 Equity Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum number of shares can be issued | 2,638,101 | ||
2015 Equity Incentive Plan | Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares available for grant | 1,085,928 | ||
Common stock shares outstanding under the Plan | 1,068,260 |
Stock Based Compensation (Det47
Stock Based Compensation (Detail Textuals 2) - Performance-based stock units | 9 Months Ended |
Jun. 30, 2017USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Term of PSUs | 10 years |
Condition for early exercise of stock based performance units | Corporate valuation in excess of $400 million |
Unamortized expense | $ 288,270 |
Period for recognition of unamortized expense | 1 year 18 days |
After third anniversary from issuance of stock units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting percentage | 50.00% |
Fourth anniversary | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting percentage | 50.00% |
Stock Based Compensation (Det48
Stock Based Compensation (Detail Textuals 3) - Restricted stock units | 9 Months Ended |
Jun. 30, 2017USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unamortized expense | $ 6,453,949 |
Period for recognition of unamortized expense | 1 year 15 days |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period of RSUs | 2 years |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period of RSUs | 4 years |
Subsequent Events (Detail Textu
Subsequent Events (Detail Textuals) - Subsequent event $ in Thousands | Jul. 25, 2017USD ($) |
Subsequent Event [Line Items] | |
Break up fee payable | $ 7,500 |
Initial upfront payment | 1,250 |
Milestone payment to be received | $ 1,250 |