Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Sep. 30, 2016 | Dec. 28, 2016 | Mar. 31, 2016 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Oncobiologics, Inc. | ||
Entity Central Index Key | 1,649,989 | ||
Trading Symbol | ons | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | --09-30 | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding | 23,578,942 | ||
Entity Public Float | $ 0 | ||
Document Type | 10-K | ||
Document Period End Date | Sep. 30, 2016 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Current assets: | ||
Cash | $ 2,351,887 | $ 9,070,975 |
Accounts receivable | 20,000 | |
Stock subscription receivable | 4,280,149 | |
Prepaid and other current assets | 3,326,607 | 1,793,109 |
Total current assets | 5,678,494 | 15,164,233 |
Property and equipment, net | 16,958,553 | 17,759,938 |
Restricted cash | 216,086 | 213,663 |
Deferred offering costs | 960,563 | |
Other assets | 852,801 | 910,224 |
Total assets | 23,705,934 | 35,008,621 |
Current liabilities: | ||
Current portion of debt | 586,454 | 742,646 |
Current portion of capital lease obligations | 977,248 | 862,849 |
Current portion of stockholder notes | 4,612,500 | 14,214,196 |
Accounts payable | 5,071,520 | 11,563,055 |
Accrued expenses | 6,121,942 | 5,924,648 |
Income taxes payable | 1,854,629 | 1,754,629 |
Deferred revenue | 1,212,561 | 1,979,576 |
Total current liabilities | 20,436,854 | 37,041,599 |
Long-term debt | 2,233,803 | 2,922,764 |
Capital lease obligations | 320,737 | 1,219,373 |
Stockholder notes | 2,000,000 | |
Deferred revenue | 5,153,384 | 6,365,945 |
Stock-based compensation liability | 12,726,722 | |
Other liabilities | 761,334 | 284,710 |
Total liabilities | 28,906,112 | 62,561,113 |
Commitments (Note 9) | ||
Redeemable preferred stock, common stock and noncontrolling interests: | ||
Redeemable common stock - 1,739,130 shares issued and outstanding at September 30, 2015 | 15,426,673 | |
Redeemable noncontrolling interests | 1,703,777 | |
Total redeemable preferred stock, common stock and noncontrolling interests | 27,321,311 | |
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 value | 228,028 | 39,844,900 |
Additional paid-in capital | 141,965,342 | |
Accumulated deficit | (147,393,548) | (94,064,286) |
Total Oncobiologics, Inc. stockholders' equity (deficit) | (5,200,178) | (54,219,386) |
Noncontrolling interests | (654,417) | |
Total stockholders' equity (deficit) | (5,200,178) | (54,873,803) |
Total liabilities, redeemable preferred stock, common stock, noncontrolling interests and stockholders' equity (deficit) | 23,705,934 | 35,008,621 |
Series A redeemable preferred stock | ||
Redeemable preferred stock, common stock and noncontrolling interests: | ||
Redeemable preferred stock | 5,072,653 | |
Series B redeemable preferred stock | ||
Redeemable preferred stock, common stock and noncontrolling interests: | ||
Redeemable preferred stock | $ 5,118,208 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2016 | Sep. 30, 2015 |
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, no par value (in dollars per share) | $ 0 | $ 0 |
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Common stock, shares, issued | 22,802,778 | 9,436,294 |
Common stock, shares, outstanding | 22,802,778 | 9,436,294 |
Redeemable stock, shares issued | 0 | 1,739,130 |
Redeemable stock, shares outstanding | 0 | 1,739,130 |
Series A redeemable preferred stock | ||
Redeemable stock, shares authorized | 0 | 8,000 |
Redeemable stock, shares issued | 0 | 3,568 |
Redeemable stock, shares outstanding | 0 | 3,568 |
Series B redeemable preferred stock | ||
Redeemable stock, shares authorized | 0 | 4,000 |
Redeemable stock, shares issued | 0 | 4,000 |
Redeemable stock, shares outstanding | 0 | 4,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Income Statement [Abstract] | ||
Collaboration revenues | $ 2,979,576 | $ 5,219,237 |
Operating expenses: | ||
Research and development | 33,101,543 | 38,876,040 |
General and administrative | 21,636,345 | 12,905,823 |
Operating expenses total | 54,737,888 | 51,781,863 |
Loss from operations | (51,758,312) | (46,562,626) |
Interest expense, net | 1,467,950 | 2,297,339 |
Loss before income taxes | (53,226,262) | (48,859,965) |
Income tax expense (benefit) | 103,000 | (190,111) |
Net loss | (53,329,262) | (48,669,854) |
Less: Net loss attributable to noncontrolling interests | (1,276,571) | |
Net loss attributable to Oncobiologics, Inc. | (53,329,262) | (47,393,283) |
Accretion of redeemable preferred stock and noncontrolling interests | (2,463,160) | (4,306,488) |
Deemed dividends upon the repurchase of Series A redeemable preferred stock and redeemable noncontrolling interests | (1,298,631) | |
Deemed dividend upon issuance of warrants to common stockholders | (7,373,820) | |
Net loss attributable to common stockholders of Oncobiologics, Inc. | $ (63,166,242) | $ (52,998,402) |
Per share information: | ||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (3.67) | $ (5.43) |
Weighted average shares outstanding, basic and diluted (in shares) | 17,212,983 | 9,753,616 |
Consolidated Statements of Rede
Consolidated Statements of Redeemable Preferred Stock, Common Stock, Noncontrolling Interests and Stockholders' Equity (Deficit) -(Unaudited) - USD ($) | Redeemable Preferred Stock, Common Stock and Noncontrolling InterestsPreferred StockSeries A | Redeemable Preferred Stock, Common Stock and Noncontrolling InterestsPreferred StockSeries B | Redeemable Preferred Stock, Common Stock and Noncontrolling InterestsCommon stock | Redeemable Preferred Stock, Common Stock and Noncontrolling InterestsNoncontrolling Interests | Preferred StockSeries A | Common stock | Additional Paid-in Capital | Accumulated Deficit | Noncontrolling Interests | Total |
Balance at Sep. 30, 2014 | $ 4,787,996 | $ 4,589,872 | $ 12,225,096 | $ 3,101,047 | $ (45,151,218) | $ (45,151,218) | ||||
Balance (in shares) at Sep. 30, 2014 | 3,681 | 4,000 | 1,739,130 | 7,670,783 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Distribution of common stock in Sonnet Biotherapeutics, Inc. to stockholders | (221,154) | 221,154 | ||||||||
Contributions to noncontrolling interests | 401,000 | 401,000 | ||||||||
Repurchase of Series A redeemable preferred stock and deemed dividends | $ (142,370) | (1,546,818) | (83,631) | (83,631) | ||||||
Repurchase of Series A redeemable preferred stock and deemed dividends (in shares) | (113) | |||||||||
Repurchase of redeemable noncontrolling interests and deemed dividends | (1,215,000) | (1,215,000) | ||||||||
Forfeitures of restricted stock | ||||||||||
Sale of common stock, net of issuance costs | $ 44,142,463 | 44,142,463 | ||||||||
Sale of common stock, net of issuance costs (in shares) | 1,765,511 | |||||||||
Accretion of redeemable common stock | $ 427,027 | $ 528,336 | $ 3,201,577 | 149,548 | $ (4,306,488) | (4,306,488) | ||||
Stock-based compensation expense | 8,925 | 8,925 | ||||||||
Net loss | (47,393,283) | (1,276,571) | (48,669,854) | |||||||
Balance at Sep. 30, 2015 | $ 5,072,653 | $ 5,118,208 | $ 15,426,673 | 1,703,777 | $ 39,844,900 | (94,064,286) | (654,417) | (54,873,803) | ||
Balance (in shares) at Sep. 30, 2015 | 3,568 | 4,000 | 1,739,130 | 9,436,294 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Deconsolidation of Sonnet Biotherapeutics, Inc. | 654,417 | 654,417 | ||||||||
Employee tax withholdings related to the vesting of restricted stock | $ (71,760) | (71,760) | ||||||||
Employee tax withholdings related to the vesting of restricted stock (in shares) | (2,782) | |||||||||
Sale of common stock, net of issuance costs | $ 5,734 | 16,132,179 | 16,137,913 | |||||||
Sale of common stock, net of issuance costs (in shares) | 573,388 | |||||||||
Accretion of redeemable common stock | $ 2,463,160 | (2,463,160) | (2,463,160) | |||||||
Reincorporation to a Delaware Corporation | $ (5,072,653) | $ (5,118,208) | $ 102 | $ (39,656,869) | 49,847,628 | 10,190,861 | ||||
Reincorporation to a Delaware Corporation (in shares) | (3,568) | (4,000) | 10,193 | 2,193,601 | ||||||
Issuance of common stock upon the dissolution of Parilis | (1,703,777) | $ 16 | $ 2,267 | 1,701,494 | 1,703,777 | |||||
Issuance of common stock upon the dissolution of Parilis (in shares) | 1,626 | 226,663 | ||||||||
Reclassification of stock-based compensation liability | 15,118,584 | 15,118,584 | ||||||||
Sale of common stock units upon consummation of initial public offering and concurrent private placement, net of issuance costs | $ 66,667 | 33,717,538 | 33,784,205 | 33,784,205 | ||||||
Sale of common stock units upon consummation of initial public offering and concurrent private placement, net of costs (in shares) | 6,666,666 | |||||||||
Reclassification of redeemable common stock upon consummation of the initial public offering | $ (17,889,833) | $ 17,391 | 17,872,442 | 17,889,833 | ||||||
Reclassification of redeemable common stock upon consummation of the initial public offering (In shares) | (1,739,130) | 1,739,130 | ||||||||
Conversion of Series A preferred stock in connection with the initial public offering | $ (118) | $ 19,698 | (19,580) | |||||||
Conversion of Series A preferred stock in connection with the initial public offering (in shares) | (11,819) | 1,969,818 | ||||||||
Stock-based compensation expense | 10,058,217 | 10,058,217 | ||||||||
Net loss | (53,329,262) | (53,329,262) | ||||||||
Balance at Sep. 30, 2016 | $ 228,028 | $ (147,393,548) | $ (5,200,178) | |||||||
Balance (in shares) at Sep. 30, 2016 | 22,802,778 | 141,965,342 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
OPERATING ACTIVITIES | ||
Net loss | $ (53,329,262) | $ (48,669,854) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,394,279 | 1,824,600 |
Non-cash interest expense | 13,465 | 12,264 |
Stock-based compensation | 12,450,079 | 11,177,858 |
Loss on disposal of fixed assets | 13,647 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 20,000 | (20,000) |
Prepaid expenses and other current assets | (1,533,498) | (1,021,852) |
Other assets | 57,423 | (322,729) |
Accounts payable | (5,326,374) | 6,580,722 |
Accrued expenses | 1,154,712 | 2,240,800 |
Income taxes payable | 100,000 | 190,218 |
Deferred revenue | (1,979,576) | 530,763 |
Other liabilities | 482,433 | 1,010 |
Net cash used in operating activities | (45,482,672) | (27,476,200) |
INVESTING ACTIVITIES | ||
Purchase of property and equipment | (1,098,180) | (8,804,244) |
Net cash used in investing activities | (1,098,180) | (8,804,244) |
FINANCING ACTIVITIES | ||
Repurchase of Series A redeemable preferred stock | (226,001) | |
Proceeds from the sale of common stock, net of offering costs | 16,137,913 | 41,249,998 |
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 | (4,637,647) | |
Proceeds from subscriptions receivable | 4,280,149 | |
Proceeds from the sale of equity in noncontrolling interest | 401,000 | |
Proceeds from stockholders notes | 10,880,252 | |
Payments of capital leases obligations | (884,620) | (686,676) |
Proceeds from debt | 200,416 | |
Repayment of debt | (1,059,034) | (725,598) |
Repayment of stockholder notes | (11,601,696) | (7,888,658) |
Change in restricted cash | (2,423) | (2,211) |
Proceeds from Sonnet Biotherapeutics, Inc | 826,561 | |
Deconsolidation of Sonnet Biotherapeutics, Inc. | (401,091) | |
Payment of employee tax withholdings related to the vesting of restricted stock | (71,760) | |
Net cash provided by financing activities | 39,861,764 | 43,002,106 |
Net (decrease) increase in cash | (6,719,088) | 6,721,662 |
Cash at beginning of year | 9,070,975 | 2,349,313 |
Cash at end of year | 2,351,887 | 9,070,975 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,477,913 | 1,402,209 |
Cash paid for income taxes | 3,000 | 2,250 |
Supplemental schedule of noncash investing activities: | ||
Purchases of property and equipment in accounts payable and accrued expenses | 634,941 | (2,770,730) |
Supplemental schedule of noncash financing activities: | ||
Accretion of redeemable preferred stock, common stock and noncontrolling interests | 2,463,160 | 4,306,488 |
Deemed dividend upon repurchase of Series A redeemable preferred stock in excess of carrying value | (1,298,631) | |
Issuance of subscription receivable upon sale of common stock | (4,280,149) | |
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 | |
Distribution of common stock in Sonnet Biotherapeutics, Inc. to stockholders | (221,154) | |
Issuance of capital lease obligations in connection with purchase of property and equipment | 100,383 | 2,603,894 |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses | $ 3,144 | $ 2,310,961 |
Organization and Operations
Organization and Operations | 12 Months Ended |
Sep. 30, 2016 | |
Organization And Description Of Business [Abstract] | |
Organization and Description of Business | 1. Organization and Operations Description of the Business Oncobiologics, Inc. (“Oncobiologics” or the “Company”) was incorporated in New Jersey on January 5, 2010 and started operations in July 2011. 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 ® ® In April 2015, the Company spun-off certain assets unrelated to its biosimilar business through a pro rata distribution to its stockholders through a newly-formed subsidiary, Sonnet Biotherapeutics, Inc. (“Sonnet”). Concurrent with the Company’s contribution of the assets relating to the innovation business of Sonnet, the Company distributed all of its shares of Sonnet to Oncobiologics’ stockholders. 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. As a result of the merger, each share of the Company’s previously issued and outstanding common stock converted into and became a share of common stock of the Delaware corporation on a 1-for-1 basis, each share of the Company’s previously issued and outstanding Series A redeemable preferred stock converted into 289 shares of common stock and approximately 1.4035 shares of Series A preferred stock of the Delaware corporation, and each share of the Company’s previously issued and outstanding Series B redeemable preferred stock converted into 289 shares of common stock and approximately 1.2867 shares of Series A preferred stock of the Delaware corporation. The holders of Series A and B also received an aggregate of 10,193 shares of Series A preferred stock of the Delaware corporation. Additionally, effective upon the reincorporation and in connection with the dissolution of the Company’s business development subsidiary, Parilis Biopharmaceuticals (“Parilis”), the Company issued 226,663 shares of common stock and 1,626 shares of Series A preferred stock to the holders of outstanding Parilis preferred member units in exchange for all such units. 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. On May 18, 2016, the Company filed an amended and restated certificate of incorporation (the “Restated Certificate”) with the Secretary of State of the State of Delaware in connection with the closing of its IPO. As set forth in the Restated Certificate, the Company’s authorized capital stock now consists of 200,000,000 shares of common stock, par value $0.01 per share, and 10,000,000 shares of preferred stock, par value $0.01 per share. |
Liquidity
Liquidity | 12 Months Ended |
Sep. 30, 2016 | |
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 $147.4 million as of September 30, 2016. In addition, the Company has $4.6 million of indebtedness that is due on demand. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying 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 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 has substantial indebtedness that includes $4.6 million in notes payable to stockholders that are payable on demand. There can be no assurance that note holders will not exercise their right to demand repayment. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its products currently in development. The Company closed the IPO of its securities and the concurrent private placement on May 18, 2016 raising aggregate net proceeds of approximately $33.8 million, excluding any proceeds it may receive from the exercise of the Series A warrants and Series B warrants. In October, November and December 2016, the Company raised $8.35 million of cash proceeds from the issuance of notes and warrants, of which $2.4 million was used to repay existing senior secured bank loans (see Note 15). Management believes that the Company’s existing cash as of September 30, 2016 and the net proceeds from the issuance of the notes and warrants will be sufficient to fund its operations through February 2017. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include, but are not limited to: private placements of equity and/or debt, payments from potential strategic research and development, licensing and/or marketing arrangements with pharmaceutical companies, and public offerings of equity and/or debt securities. There can be no assurance that these future funding efforts will be successful. 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 | 12 Months Ended |
Sep. 30, 2016 | |
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 consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). 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”). The consolidated financial statements include the accounts of the Company’s subsidiaries and affiliates in which the Company held a controlling financial interest as of the financial statement date. As the Company had been the primary funding source for Sonnet, the operations and financial position of Sonnet were included in the consolidated financial statements of the Company through September 30, 2015. Participation of the stockholders in the net assets and losses of Sonnet were reflected in the line items “Noncontrolling interests” in the Company’s consolidated balance sheet and “Net loss attributable to the noncontrolling interests” in the Company’s consolidated statement of operations. Prior to its dissolution, Parilis had issued Series A and Series A Hybrid Redeemable Preferred Units (“Preferred Units”) to investors other than Oncobiologics. The Preferred Units were redeemable both at the option of the Parilis Preferred holders and upon the occurrence of an event that was not solely within the Company’s control. Because redemption of Preferred Units was outside of the Company’s control, the noncontrolling interests was presented on the consolidated balance sheet under the caption redeemable noncontrolling interests and was carried at its current redemption value. As of and for the year ended September 30, 2015, the redeemable noncontrolling interests was presented at its carrying amount and adjusted for dividends to and contributions from the noncontrolling interests with an offsetting charge to common stock or, in the absence of common stock, a charge to accumulated deficit. Use of estimates The preparation of the 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 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 consolidated financial statements in the period they are determined to be necessary. Recapitalization On April 26, 2016, the Company filed a certificate of amendment to amend its certificate of incorporation effecting a 1-for-3.45 reverse split of the Company’s common stock. All references in the consolidated financial statements to the number of shares and per-share amounts of common stock have been retroactively restated to reflect the reverse split. Restricted cash As of September 30, 2016 and 2015, the Company had $216,086 and $213,663, respectively, in certificates of deposit related to the requirements of the Company’s bank loans. Fair value of financial instruments At September 30, 2016 and 2015, the Company’s financial instruments included accounts payable, accrued expenses, stockholder notes and debt. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments. The stockholder notes and debt approximates fair value as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. As of September 30, 2015, the carrying value of the stock-based compensation liability was the estimated fair value of the liability (See Note 11). Prepaid expenses and other current assets As of September 30, 2016 and 2015, the Company had prepaid research and development of $1,979,527 and $355,182, respectively. Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the life of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations. Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. The Company has not recognized any impairment of long-lived assets. Deferred offering costs The Company capitalizes costs that are directly associated with in-process equity financings until such financings are consummated at which time such costs are recorded against the gross proceeds of the offering. Stock-based compensation The Company measures equity classified stock-based awards granted to employees and directors based on the estimated fair value on the date of grant and recognizes compensation expense of those awards, net of estimated forfeitures, on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in note 11. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant. Stock-based awards granted to consultants and non-employees are measured based on the fair value of the award on the date on which the related services are completed. Compensation expense is recognized over the period during which services are rendered by such consultants and non-employees until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option-pricing model. Stock-based awards that are settled in cash are accounted for as liabilities and are remeasured at each reporting period until the obligations are satisfied. Stock-based compensation liabilities are valued through the use of a Monte Carlo simulation model. Revenue recognition The Company’s revenue is generated primarily through collaboration research and license agreements. The terms of these agreements generally contain multiple deliverables which may include (i) licenses, (ii) research and development activities, clinical manufacturing, and (iii) product supply. The payment terms of these agreements may include nonrefundable upfront fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. The Company considers whether the deliverables under the arrangement represent separate units of accounting. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have stand-alone value. The consideration received is allocated to the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company typically receives upfront, nonrefundable payments when licensing its intellectual property. For intellectual property licenses that do not have stand-alone value from the other deliverables to be provided, the upfront fee is deferred and revenue is recognized over the contractual or estimated performance period, which is typically the term of the research and development obligations. The periods over which revenue is recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue. The Company recognizes revenue from milestone payments when: (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement, and (ii) the Company does not have ongoing performance obligations related to the achievement of the milestone earned. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment (a) is commensurate with either the Company’s performance to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the Company’s performance to achieve the milestone, (b) relates solely to past performance, and (c) is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, 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. 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. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accretion of redeemable preferred stock, redeemable common stock and redeemable noncontrolling interests Accretion of redeemable preferred stock included the accretion of dividends and issuance costs of the Company’s Series A and Series B redeemable preferred stock and the redeemable common stock. The carrying values of the Series A and Series B redeemable preferred stock, redeemable common stock and redeemable noncontrolling interests were being accreted to their respective redemption values, using the effective interest method, from the date of issuance to the earliest date the holders can demand redemption. Increases to the carrying value of redeemable preferred stock, common stock, and noncontrolling interests are charged to common stock or, in the absence of common stock, charged to accumulated deficit. Upon repurchase of redeemable preferred stock and redeemable noncontrolling interests, the excess consideration paid over the carrying value at the time of repurchase was accounted for as a deemed dividends to the preferred stockholders. Net loss per share Basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares during the period. For all periods presented, the outstanding shares of Series A and Series B redeemable preferred stock have been excluded from the calculation because their effects would be anti-dilutive. Therefore the weighted-average shares used to calculate both basic and diluted loss per share are the same. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2016 and 2015, as they would be antidilutive: September 30, 2016 2015 Series A redeemable preferred stock — 1,034,181 Series B redeemable preferred stock — 1,159,418 Performance-based stock units 247,309 — Restricted stock units 1,094,351 — Convertible stockholder note — 96,618 Common stock warrants 8,186,934 — Amounts in the table above reflect the common stock equivalents of the noted instruments. Recently issued and adopted accounting pronouncements In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern 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 — assets recognized from the costs to obtain or fulfill a contract. 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 February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting, which is intended to simplify the accounting and reporting for employee share-based payment transactions. The pronouncement is effective for interim and annual periods beginning after December 31, 2016 with early adoption permitted. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Sep. 30, 2016 | |
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: September 30, 2015 (Level 1) (Level 2) (Level 3) Liabilities Stock-based compensation liability $ — $ — $ 12,726,722 The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the stock-based compensation liability for the years ended September 30, 2016 and 2015: Balance at October 1, 2014 $ 1,557,789 Change in fair value 11,168,933 Balance at September 30, 2015 12,726,722 Change in fair value 2,391,862 Reclassification to stockholders’ equity (deficit) (15,118,584 ) Balance at September 30, 2016 $ — The Company has issued stock-based performance units (“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. In addition, the PSUs are exercisable upon the earlier of (i) a change in control, (ii) consummation of an IPO, or (iii) a corporate valuation in excess of $400 million and at the discretion by the Company’s Board of Directors. Upon exercise, the PSU holder received a cash payment for the difference between the current per share value of the Company and the base price of the PSU. Given the cash settlement, the PSUs were liability classified and re-measured at each reporting date with changes in fair value recorded within the Company’s consolidated statements of operations. In December 2015, the PSUs were modified to provide for settlement in common stock or cash, at the Company’s discretion. As a result of this modification, the carrying value of the PSUs was reclassified to stockholders’ equity (deficit). The PSUs contain a market condition as the exercisability of the awards are based on the Company achieving a market value of $400 million during the relevant performance period. The fair value of the market condition is valued using a Monte Carlo simulation model. The significant assumptions used in preparing the Monte Carlo simulation model include (i) volatility of the Company’s common stock, (ii) risk free interest rate, (iii) base price of the PSUs, (iv) fair value of the Company’s common stock and enterprise value of the Company, and (v) derived service period. The fair value of the PSUs of $22.22 per PSU at September 30, 2015 was derived using the following assumptions: September 30, 2015 Risk-free interest rate 1.4% Derived service period 5 years Expected volatility 60% Annual dividend yield 0% Fair value of common stock $25.79 per share |
Property and Equipment
Property and Equipment | 12 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment, net, consists of: September 30, 2016 2015 Laboratory equipment $ 11,452,858 $ 10,936,364 Leasehold improvements 10,031,739 9,889,521 Computer software and hardware 421,206 402,075 Construction in progress 1,014,690 175,425 22,920,493 21,403,385 Less: accumulated depreciation and amortization (5,961,940 ) (3,643,447 ) $ 16,958,553 $ 17,759,938 Depreciation and amortization expense for the years ended September 30, 2016 and 2015 was $2,394,279 and $1,824,600, respectively. At September 30, 2016 and 2015, $3,630,683 and $3,530,301, 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 September 30, 2016 and 2015, $732,002 and $407,210, respectively, of accumulated depreciation related to this leased equipment has been recognized. The following is a schedule of future minimum lease payments under capital leases as of September 30, 2016: 2017 $ 1,093,624 2018 341,740 1,435,364 Less: amounts representing interest (137,379 ) Less: current portion (977,248 ) Capital lease obligations, excluding current portion $ 320,737 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Sep. 30, 2016 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consists of: September 30, 2016 2015 Compensation $ 3,884,386 $ 2,321,508 Research and development 1,343,910 951,759 Interest payable 234,754 806,475 Deferred offering costs 26,028 657,892 Professional fees 486,705 594,572 Director fees 73,125 414,421 Other accrued expenses 73,034 178,021 $ 6,121,942 $ 5,924,648 |
Stockholder Notes
Stockholder Notes | 12 Months Ended |
Sep. 30, 2016 | |
Short-term Debt [Abstract] | |
Stockholder Notes | 7. Stockholder Notes September 30, 2016 2015 Series A repurchase notes $ — $ 800,534 Parilis Series A repurchase notes — 2,275,818 Restricted stock repurchase notes 800,000 1,097,750 Common stock repurchase note 2,812,500 2,812,500 Convertible note — 2,000,000 Working capital notes 1,000,000 7,227,594 4,612,500 16,214,196 Less: current portion (4,612,500 ) (14,214,196 ) $ — $ 2,000,000 In June 2014, the Company, upon the repurchase of its Series A redeemable preferred stock, issued $3,364,534 in notes to the investors as settlement of cumulative unpaid dividends. The notes bore interest at 4.0% and were originally due in June 2015. During the year ended September 30, 2015, $64,000 of the notes were offset against advances previously made to the Company’s CEO. Additionally, $100,000 of the notes were offset against advances previously made to an investor. The Company made principal payments of $800,534 and $2,050,000 during the years ended September 30, 2016 and 2015, respectively. In October 2014, the Company, upon the repurchase of 1,215 Parilis Preferred Units, issued $2,761,818 in notes to the investors at a price of $2,000 per unit and $331,818 in cumulative unpaid dividends. During the years ended September 30, 2016 and 2015, the Company made $2,275,818 and $486,000 in principal payments, respectively. In June 2014, the Company repurchased shares of its restricted stock in exchange for $1,097,750 in notes payable. During the year ended September 30 2016, the Company paid $297,750 of the notes. The notes bear interest at rates ranging from 0% to 4% and are due on demand. The Company has a $2,812,500 note payable related to the previous repurchase of common stock that does not bear interest and is due on demand. In October and December 2014, the Company issued convertible promissory notes to a redeemable common stock investor, each in the amount of $2,000,000 and bearing interest at 12%. The December note was paid in full during the year ended September 30, 2015 and the October note was paid in full during the year ended September 30, 2016. The Company has borrowed from stockholders for working capital purposes. The notes bear interest from 0% to 30% per annum. One of the notes is collateralized by 0.3 million common shares of the Company’s founding stockholder and Chief Executive Officer (“CEO”). The notes are due on demand. During the years ended September 30, 2016 and 2015, the Company recognized interest expense related to the stockholder notes of $589,675 and $1,869,113, respectively. |
Debt
Debt | 12 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Debt | 8. Debt September 30, 2016 2015 Term loans-Bank $ 2,526,502 $ 3,404,759 Equipment loans 354,979 334,093 Unamortized debt discount (61,224 ) (73,442 ) 2,820,257 3,665,410 Less: current portion (586,454 ) (742,646 ) Long-term debt $ 2,233,803 $ 2,922,764 The term bank loans bear interest at the prime rate plus 2.75% and are adjusted monthly. The original term of the loans range from 7 to 10 years. Minimum monthly payments of principal and interest under the terms of the loans are $48,048 and are collateralized by equipment, a secured interest in the personal residence of the founding stockholder and CEO, an unconditional personal guarantee by the founding stockholder and CEO and a $200,000 certificate of deposit. In August 2016, the Company paid in full one of the three term loans. The Company maintains a life insurance policy on its founding stockholder and CEO in which the bank is the primary beneficiary. The loans contain certain non-financial covenants. The equipment loans bear interest at rates ranging from 12% to 16% with the original term of the loans ranging from 1 to 5 years. Minimum monthly payments of principal and interest under the equipment loans are $19,379 and are collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and CEO. Interest expense on the above loans for the years ended September 30, 2016 and 2015 was $230,824 and $287,280, respectively. Future maturities of debt at September 30, 2016 are as follows: 2017 $ 586,454 2018 515,793 2019 549,694 2020 569,142 2021 497,491 Thereafter 162,907 $ 2,881,481 |
Commitments
Commitments | 12 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 9. Commitments Selexis Commercial License Agreements In April 2013, the Company entered into commercial license agreements with Selexis for each of the ONS-3010, ONS-1045 and ONS-1050 biosimilar product candidates (which agreements were subsequently amended on May 21, 2014). Under the terms of each commercial license agreement, the Company acquired a non-exclusive worldwide license under the Selexis Technology to use the applicable Selexis expression technology along with the resulting Selexis materials/ cell lines, each developed under the research license, to manufacture and commercialize licensed and final products, with a limited right to sublicense. The Company paid an upfront licensing fee to Selexis for each commercial license and also agreed to pay a fixed milestone payment for each licensed product. In addition, the Company is required to pay a low single-digit royalty on a final product-by-final product and country-by-country basis, based on worldwide net sales of such final products by the Company or any of the Company’s affiliates or sublicensees during the royalty term. The royalty term for each final product in each country is the period commencing from the first commercial sale of the applicable final product in the applicable country and ending on the expiration of the specified patent coverage. At any time during the term, the Company has the right to terminate its royalty payment obligation by providing written notice to Selexis and paying Selexis a royalty termination fee. Each of the Company’s commercial agreements with Selexis will expire upon the expiration of all applicable Selexis patent rights. Either party may terminate the related agreement in the event of an uncured material breach by the other party or in the event the other party becomes subject to specified bankruptcy, winding up or similar circumstances. Either party may also terminate the related agreement under designated circumstances if the Selexis Technology infringes third-party intellectual property rights. In addition, the Company has the right to terminate each of the commercial agreements at any time at its convenience; however, with respect to the agreements relating to ONS-3010 and ONS-1045, this right is subject to the licensee’s consent pursuant to a corresponding letter the Company executed in conjunction with the standby agreement entered into between Selexis and Liomont in November 2014. The standby agreement permits Liomont to assume the license under the applicable commercial agreement for Mexico upon specified triggering events involving our bankruptcy, insolvency or similar circumstances. Technology License The Company entered into a technology license agreement that will require milestone payments of $376,000 (based on an exchange rate on September 30, 2016 for converting Swiss Francs to U.S. dollars) to the licensor by the Company upon achievement of certain clinical milestones and pay a single digit royalty on net sales by the Company utilizing such technology. The Company also has the contractual right to buy out the royalty payments at a future date. Leases In July 2016, the Company entered into a fifth amendment to its lease agreement for its office and operating space which, as amended, has a term ending in June 2021. Additionally, in August 2015, the Company entered into a lease for approximately 82,000 square feet of office and laboratory space in Cranbury, New Jersey, with lease payments that commenced in March 2016 and expire in March 2026. Rent expense under the leases was $1,619,019 and $720,875, respectively for the years ended September 30, 2016 and 2015, respectively. The Company recognizes rent expense on a straight-line basis over the lease period and has accrued for rent expense incurred but not yet paid. Landlord allowances for tenant improvements are deferred and recognized as a reduction to rent expense on a straight line basis and over the remaining lease term. Future minimum rental payments under noncancelable operating leases at September 30, 2016 are as follows: 2017 $ 1,551,513 2018 1,735,263 2019 1,753,323 2020 1,771,545 2021 1,596,976 Thereafter 3,541,990 $ 11,950,610 Employment Benefit Plan The Company maintains a defined contribution 401(k) plan in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company matches 100% of the first 3% of employee contributions. The Company assumes all administrative costs of the Plan. For the years ended September 30, 2016 and 2015, the expense relating to the matching contribution was $191,097 and $131,385, respectively. |
Redeemable Preferred Stock, Com
Redeemable Preferred Stock, Common Stock, Noncontrolling Interests and Stockholders' Equity (Deficit) | 12 Months Ended |
Sep. 30, 2016 | |
Equity [Abstract] | |
Redeemable Preferred Stock, Common Stock, Noncontrolling Interests and Stockholders' Equity (Deficit) | 10. Redeemable Preferred Stock, Common Stock, Noncontrolling Interests and Stockholders’ Equity (Deficit) Common stock During the year ended September 30, 2015, the Company sold 1,765,511 shares of its common stock at $25.79 per share under a mezzanine funding round raising $44,142,463 in net proceeds of which $4,280,149 was received in October 2015. From October 2015 through January 2016, the Company sold 573,388 shares of its common stock at $29.05 per share raising $16,137,913 in net proceeds. In May 2016, upon consummation of its IPO and private placement, the Company sold 5,833,334 units at $6.00 per unit and 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, at the same price (See Note 1), raising $33,784,205 in aggregate net proceeds. Each unit consisted of one share of the Company’s common stock and warrants described below. Concurrent with the closing of the IPO, 1,739,130 shares of redeemable common stock were reclassified to common stock upon the lapse of a contractual redemption right. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Subject to preferences that may apply to any outstanding preferred stock, holders of common stock are entitled to receive ratably any dividends that the Company’s board of directors may declare out of funds legally available for that purpose on a non-cumulative basis. No dividends had been declared through September 30, 2016. Series A warrants and Series B warrants Each unit offered in connection with the Company’s IPO consisted of one share of the Company’s common stock, one-half of a Series A warrant to purchase one share of the Company’s common stock and one-half of a Series B warrant to purchase one share of the Company’s common stock. The Company also issued Series A warrants and Series B warrants in the concurrent private placement (see Note 1). Each whole Series A warrant and Series B warrant has an exercise price of $6.60 per share and $8.50 per share, respectively, and are exercisable until February 18, 2017 and May 18, 2018, respectively. Neither the Series A warrant holders nor Series B warrant holders has the rights or privileges of holders of common stock or any voting rights until they exercise their warrants and receive common stock. The exercise price and number of shares issuable upon exercise of the Series A and Series B warrants may be adjusted upon the occurrence of certain events, including but not limited to any stock split, stock dividend, extraordinary dividend, recapitalization, reorganization, merger or consolidation. As of September 30, 2016, there were 3,333,333 Series A warrants and 3,333,333 Series B warrants outstanding. Common stock warrants In May 2016, upon the closing of the IPO, the Company issued warrants to acquire an aggregate of 1,520,268 shares of its common stock to certain of the investors party to that certain investors’ rights agreement dated March 10, 2014, as amended, pursuant to the terms of an amendment to such agreement dated April 26, 2016. The warrants issued to these investors are not exercisable until 180 days after May 12, 2016, and have an initial exercise price of $0.01 per share, which may increase to $1.00 per share under certain circumstances, and expire November 18, 2019. The estimated fair value of the warrants issued to these investors was $7,373,820 and reflected as a deemed dividend in the consolidated statement of operations for purposes of computing basic and diluted loss per share. Deconsolidation of noncontrolling interests Through September 30, 2015, the Company consolidated the operations of Sonnet because the Company was the primary funding source to Sonnet through September 2015. Effective October 1, 2015, additional capital was contributed to Sonnet by third-party investors triggering a reconsideration event, which resulted in the Company no longer being considered the primary beneficiary and as a result, the Company has deconsolidated Sonnet. Sonnet issued the Company an $826,561 promissory note which reflects the funding the Company provided Sonnet through September 30, 2015. There were no gains or losses recognized upon deconsolidation because no equity interest was owned by the Company. As of September 30, 2016, the balance of the promissory note plus accrued interest was paid in full. Series A preferred stock In connection with the closing of the Company’s IPO, all outstanding shares of Series A preferred stock converted into 1,969,818 shares of common stock. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 11. 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 September 30, 2016, PSUs representing 247,309 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. On July 11, 2016 the maximum number of shares of the 2015 plan increased by 684,083 shares or 3% of the outstanding common stock of the Company. This increase resulted from a provision in the plan that allows an annual increase of shares in the plan. The maximum number of shares of common stock that may be issued under the 2015 Plan is 1,930,460 shares. As of September 30, 2016, RSUs representing 1,094,351 shares of the Company’s common stock were outstanding under the 2015 Plan and 836,109 shares remained available for grant under the 2015 Plan. The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations for the years ended September 30, 2016 and 2015: Year ended September 30, 2016 2015 Research and development $ 2,044,379 $ 5,817,830 General and administrative 10,405,700 5,360,028 $ 12,450,079 $ 11,177,858 Year ended September 30, 2016 2015 Equity-classified compensation $ 10,058,217 $ 8,925 Liability-classified compensation 2,391,862 11,168,933 $ 12,450,079 $ 11,177,858 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 and at the discretion by the Company’s board of directors. Upon exercise, the PSU holder receives common stock or cash at the Company’s discretion. See note 4 for discussion of fair value of the PSUs. The following table summarizes the PSU activity for the years ended September 30, 2016 and 2015: Number of PSUs Base Price Per PSU Balance at October 1, 2014 658,498 $ 3.45 Granted 39,988 3.45 Forfeitures (11,473 ) 3.45 Balance at October 1, 2015 687,013 3.45 Forfeitures (4,924 ) 4.85 Exchanged for restricted stock units (434,780 ) 3.45 Balance at September 30, 2016 247,309 $ 6.33 In December 2015, the Company completed a tender-offer to holders of outstanding PSUs to amend the terms of such outstanding awards to increase the base price to an amount equal to the fair market value of a share of the Company’s common stock on the date of grant of the PSU, remove the right to be paid dividend equivalents and provide for settlement in shares of the Company’s common stock or cash, at the Company’s discretion. Upon amending the settlement terms of the PSUs, the Company reclassified the stock-based compensation liability to additional paid-in capital. Concurrent with the tender-offer, several PSU holders cancelled an aggregate of 434,780 PSUs in exchange for 391,303 RSUs. The Company accounted for the exchange as a modification, and, as a result, recognized $98,172 of additional stock-based compensation during the year ended September 30, 2016 based on the fair value of the RSUs in excess of the fair value of the PSUs exchanged. The PSU represents an award that is exercisable based upon the achievement of either a performance condition or a market condition. As a result, the Company measures and records compensation cost taking into consideration both conditions: (1) an award that becomes exercisable upon the Company achieving a market value of $400 million and at the discretion by the Company’s Board of Directors and (2) an award that is exercisable upon the earlier of a change in control or consummation of an IPO. Through December 2015, the fair value of both the performance and market conditions were remeasured prior to the PSUs being reclassified into equity. However, given the discretionary action required to be taken by the Company’s Board of Directors, the fair value of the market condition continued to be remeasured each reporting period as compensation cost was recognized. Because a change of control or an IPO is not deemed probable until such event occurs, no compensation cost related to the performance condition was recognized prior to the consummation of the Company’s IPO. Upon the consummation of the IPO in May 2016, the Company recorded compensation expense for the year ended September 30, 2016 based upon the fair value of the performance condition of the PSUs which was established in December 2015 when the PSUs became equity classified. The fair value of the PSUs of $25.74 per PSU at December 31, 2015 was derived using the following assumptions: December 31, 2015 Risk-free interest rate 1.0% Derived service period 2.3 years Expected volatility 57.6% Annual dividend yield 0% Fair value of common stock $29.05 per share As of September 30, 2016, there was $646,531 of unamortized expense that will be recognized over a weighted-average period of 1.71 years. Restricted stock units The following table summarizes the activity related to RSUs granted during the year ended September 30, 2016: Number of RSUs Weighted Average Grant Date Fair Value Balance at October 1, 2015 — $ — Granted 705,311 28.31 Forfeitures (2,263 ) 13.78 Issued in connection with PSU exchange 391,303 29.05 Balance at September 30, 2016 1,094,351 $ 28.61 As of September 30, 2016, there were 387,868 RSUs that will vest upon the expiration of the 180-day lock up period following the Company’s IPO. The remaining 706,483 RSUs will vest upon the expiration of the 180-day lock up period following the Company’s IPO and over the following time-based vesting periods: • 424,468 RSUs with 50% vesting on each of the first and second anniversaries of the recipient’s grant date • 21,738 RSUs with one-third vesting on each of the first, second, and third anniversaries of the recipient’s hire date • 260,277 RSUs with 50% vesting on each of the third and fourth anniversaries of the recipient’s hire date The expiration of the lock-up period following an IPO or a change in control are performance conditions that are 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 September 30, 2016, there was $12,527,573 of unamortized expense that will be recognized over a weighted-average period of 1.53 years. |
Collaboration Arrangements
Collaboration Arrangements | 12 Months Ended |
Sep. 30, 2016 | |
Collaboration Arrangements [Abstract] | |
Collaboration Arrangements | 12. Collaboration Arrangements Huahai agreement In May 2013, the Company entered into strategic license and collaboration arrangement with Zhejiang Huahai Pharmaceutical Co., Ltd (“Huahai”) under which the Company granted Huahai and its affiliates an exclusive license for the research, development, manufacture, use or sale of ONS-3010 or ONS-1045 in China, including, the People’s Republic of China, Hong Kong, Macau and Taiwan. In addition, the Company granted Huahai a right and license under the Selexis Technology agreement to establish a production process for the products in the agreed territory and to market the products in the agreed territory pursuant to the relevant terms and conditions of the Company’s commercial license agreement with Selexis. Under the terms of the arrangement, the Company has received $7,500,000 in upfront payments and non-substantive milestones and received $8,500,000 in substantive milestones. The Company determined that the deliverables under the Huahai arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have standalone value, the upfront and non-substantive milestones payments received have been deferred and are being recognized ratably on a straight line basis through December 2019, the expected date in which the research and development will be completed. Substantive milestones received under the Huahai arrangement are recognized upon achievement. During each of the years ended September 30, 2016 and 2015, the Company recognized $1,175,580 of deferred revenues. For the year ended September 30, 2015, the Company received and recognized $2,000,000 in substantive milestone payments. As of September 30, 2016 and 2015, deferred revenue included in the Company’s consolidated balance sheet related to the Huahai arrangement was $3,752,950 and $4,928,530, respectively. IPCA License and Collaboration Agreement In August 2013, the Company entered into a strategic license agreement with IPCA Laboratories Limited and its affiliates (“IPCA”) under which the Company granted IPCA a license for the research, development, manufacture, use or sale of the ONS-3010 and, by amendment in May 2014, the ONS-1045 biosimilar product candidates with respect to India, Sri-Lanka, and Myanmar, and non-exclusive with respect to Nepal and Bhutan, or collectively, the agreed territory. In addition, the Company granted IPCA a right and license under the Selexis Technology to enable IPCA to establish an exclusive production process for the products in its agreed territory and to exclusively market the products in the agreed territory. The Company also agreed not to amend or terminate its rights under its commercial license agreement with Selexis without IPCA’s prior written consent. Pursuant to the agreement, the Company agreed to continue the non-clinical and clinical development of each of ONS-3010 and ONS-1045 and corresponding products around the world and to develop and commercialize such products through Phase 3 clinical trials and regulatory approval in the United States and European Union. These obligations continue until termination of the agreement or the individual development programs or upon final regulatory approval of the last product for such biosimilars in the United States or European Union. The Company agreed to provide IPCA with a pre-IND package as submitted to EMEA and FDA, as well as perform preclinical development and characterization of ONS-3010 and ONS-1045 so as to enable IPCA to file an IND to conduct clinical trials and to perform clinical trials. Under the terms of the agreement, the Company has received upfront and non-substantive milestone payments of $2,400,000, and received $1,000,000 in regulatory milestone payments. In addition, the Company is eligible to receive royalties at a low double-digit percentage rate of annual net sales of products by IPCA and its affiliates in the agreed territory. For each of ONS-3010 and ONS-1045, IPCA agreed to fund a portion of the global costs associated with the Phase 3 clinical trials. The Company determined that the deliverables under the IPCA arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have standalone value, the upfront and non-substantive milestones payments received have been deferred and are being recognized ratably on a straight line basis through December 2019, the expected date in which the research and development will be completed. Substantive milestone payments received under the IPCA arrangement are recognized upon achievement. Cost reimbursements from IPCA related to the global costs associated with the Phase 3 clinical trials are recorded as a reduction in research and development expense. During the years ended September 30, 2016 and 2015, the Company recognized deferred revenues of $421,732 and $402,377, respectively. For the year ended September 30, 2015, the Company received and recognized a $500,000 substantive milestone payment. As of September 30, 2016 and 2015, deferred revenue included in the Company’s consolidated balance sheets was $1,370,630 and $1,792,362, respectively. Strategic Collaboration and Non-Exclusive License Agreement In January 2014, the Company entered into a strategic collaboration and license agreement with IPCA to assist IPCA in establishing its research, development and manufacturing capabilities for monoclonal antibodies and biologics, including, in part, through collaborative development, manufacture and commercialization of ONS-1050 in the agreed territory (as specified below). Under the agreement, the Company granted IPCA and its affiliates a non-exclusive license in the agreed territory for the research, development, manufacture, use or sale of ONS-1050. The Company also agreed to assist IPCA with its research and development program. The agreed territory for ONS-1050 includes the Republics of India, Sri-Lanka, and Myanmar, Nepal and Bhutan, while the agreed territory for any product candidates developed independent of the Company’s involvement is global without geographical restriction. Any further collaboration between for such independently developed product candidates will be the subject of a separate written agreement if required by IPCA. Under the terms of the agreement, the Company receives development payments and commercialization fees. In addition, the Company is eligible to receive royalties from IPCA at a mid-single digit rate on annual net sales of ONS-1050 commercialized by IPCA and its affiliates in the agreed territory. The Company accounts for the agreement with IPCA as a research and development services arrangement and recognizes revenue under the proportional performance model. For the years ended September 30, 2016 and 2015, the Company recognized revenue of $0 and $800,000, respectively. Liomont agreement In June 2014, the Company entered into a strategic license agreement with Laboratorios Liomont, S.A. (“Liomont”), under which the Company granted Liomont and its affiliates an exclusive, sublicenseable license in Mexico for the research, development, manufacture, use or sale of the ONS-3010 and ONS-1045 biosimilar product candidates in Mexico. In addition, the Company granted Liomont a non-exclusive right and license under the Selexis Technology and related intellectual property to enable Liomont to distribute, market and commercialize the products in Mexico. The Company also agreed not to amend or terminate its rights under the commercial agreement with Selexis without Liomont’s prior written consent. Under the terms of the agreement, the Company has received upfront payments and non-substantive milestone payments of $2,000,000 and received $1,000,000 in regulatory milestone payments. In addition, the Company is eligible to receive up to $2,000,000 in future substantive milestone payments. For each of ONS-3010 and ONS-1045, Liomont agreed to fund a portion of the global costs for Phase 3 clinical trials. The Company is eligible to receive tiered royalties at upper single-digit to low double-digit percentage rates of annual net sales of products by Liomont and its affiliates in Mexico. The Company determined that the deliverables under the Liomont arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have standalone value, the upfront payments received have been deferred and are being recognized ratably on a straight line basis through December 2019, the expected date in which the research and development will be completed. Cost reimbursements from Liomont related to the global costs associated with the Phase 3 clinical trials are recorded as a reduction in research and development expense. During the years ended September 30, 2016 and 2015, the Company recognized deferred revenue of $382,264 and $341,280, respectively. As of September 30, 2016 and 2015, deferred revenue included in the Company’s consolidated balance sheets was $1,242,365 and $1,624,629. |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Sep. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 13. Related-Party Transactions During the years ended September 30, 2016 and 2015, the following related party transactions occurred other than as disclosed in Note 7 and Note 8: • During the year ended September 30, 2015, the Company provided $783,707 of non-interest bearing advances to the Company’s founding stockholder and CEO, of which $395,257 was repaid. Additionally, the CEO has deferred a portion of his salary, bonus, and related benefits during the year ended September 30, 2015 and applied such deferrals against previous advances. As of September 30, 2015, the Company had accrued compensation payments of $117,506, due to the CEO. • In March 2015, a director of the Company loaned $1,000,000 to the Company with an interest rate of 24%. The loan was repaid in October 2015 and included $128,219 in accrued interest. • During the years ended September 30, 2015 and 2014, the Company repurchased 1,250 shares of Series A redeemable preferred stock and satisfied accrued dividends of $326,354 from three directors of the Company in exchange for $650,000 in cash payments and the issuance of $1,850,000 in stockholder notes. The notes bear interest at 4% which are due on demand. Under the terms of the agreement, because the notes were not paid upon maturity, they now bear interest at 6%. Terms of the share repurchase were the same as non-related parties. Refer to notes 7 and 10. |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes Income tax expense (benefit) for the years ended September 30, 2016 and 2015 consists of the following: Year Ended September 30, 2016 2015 State tax, including sale of New Jersey losses and credits $ 3,000 $ (725,969 ) Foreign tax provision 100,000 535,858 $ 103,000 $ (190,111 ) The Company has been eligible to receive cash from the sale of its net operating losses (“NOLs”) and R&D tax credits under the State of New Jersey Technology Business Tax Certificate Transfer Program. During the year ended September 30, 2015, the Company received $0.7 million from the sale of New Jersey NOLs. In addition, the Company incurred $0.1 million and $0.5 million of foreign withholding taxes in connection with the Company’s collaboration and licensing agreements during the years ended September 30, 2016 and 2015, respectively. A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: Year Ended September 30, 2016 2015 U.S. federal statutory rate (34.0 )% (34.0 )% State taxes, net of federal benefit (5.9 ) (5.5 ) Foreign withholding tax 0.2 1.1 Permanent differences — 1.8 Foreign tax credits — (1.1 ) Research and development credit — (6.9 ) Change in valuation allowance 40.0 44.6 Other (0.1 ) (0.4 ) Effective income tax rate 0.2 % (0.4 )% The tax effects of the temporary differences that gave rise to deferred taxes were as follows: Year Ended September 30, 2016 2015 Deferred tax assets Net operating loss carryforwards $ 36,146,789 $ 20,164,392 Stock compensation 11,249,314 6,317,492 Deferred revenue 2,542,558 3,333,201 Research and development credit carryforward 757,701 5,979,964 Foreign tax credits 2,257,309 2,602,949 Accruals and others 1,287,592 1,072,422 Gross deferred tax assets 54,241,263 39,470,420 Less: valuation allowance (52,737,104 ) (38,694,795 ) 1,504,159 775,625 Deferred tax liability: Fixed assets (1,504,159 ) (775,625 ) Net deferred tax assets $ — $ — As of September 30, 2016, the Company has approximately $99.8 million and $37.0 million of Federal and New Jersey net operating losses that will begin to expire in 2030 and 2036, respectively. As of September 30, 2016, the Company has Federal research and development tax credit carryforwards of $0.8 million available to reduce future tax liabilities which will begin to expire in 2032. As of September 30, 2016, the Company has Federal foreign tax credit carryforwards of $2.3 million available to reduce future tax liabilities which will begin to expire starting in 2023. $1.8 million of the FTC carryforward is included in the balance of unrecognized tax benefits. Realization of the deferred tax asset is contingent on future taxable income and based upon the level of historical losses, management has concluded that the deferred tax asset does not meet the more-likely-than-not threshold for realizability. Accordingly, a full valuation allowance continues to be recorded against the Company’s deferred tax assets as of September 30, 2016 and 2015. The valuation allowance increased $14.0 million and $21.3 million during the years ended September 30, 2016 and 2015, respectively. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely-than-not be realized. The determination as to whether the tax benefit will more-likely-than-not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes interest and penalties accrued on any unrecognized tax benefits within the provision for income taxes in its consolidated statements of operations. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Year Ended September 30, 2016 2015 Balance at beginning of year $ 1,754,629 $ 1,564,411 Additions based on tax positions related to the current year 100,000 190,218 Balance at end of year 1,854,629 1,754,629 The Company does not anticipate material change in the unrecognized tax benefits in the next 12 months. These unrecognized tax benefits, if recognized, would affect the annual effective tax rate. The Company’s income tax returns for the years from 2011 through 2015 remain open for examination by the Internal Revenue Service as well as various state, local and foreign jurisdictions. Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company’s net operating loss carryforwards may be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carry forward is subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there would be a reduction in the deferred tax assets with an offsetting reduction in the valuation allowance. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Sep. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events 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. On December 22, 2016, the Company entered into a Note and Warrant Purchase Agreement 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 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 Company used $2.4 million of the proceeds from the sale of the Notes to pay off its existing senior secured bank loans, and will use the remainder for working capital purposes. The Company may issue up to $1.65 million of additional Notes and Warrants to acquire up to an additional 379,500 shares of the Company’s common stock in additional closings over the next 90 days without approval of holders of the Notes. Under the Note and Warrant Purchase Agreement, 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 Note and Warrant Purchase Agreement, 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. |
Basis of Presentation and Sum22
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). 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”). The consolidated financial statements include the accounts of the Company’s subsidiaries and affiliates in which the Company held a controlling financial interest as of the financial statement date. As the Company had been the primary funding source for Sonnet, the operations and financial position of Sonnet were included in the consolidated financial statements of the Company through September 30, 2015. Participation of the stockholders in the net assets and losses of Sonnet were reflected in the line items “Noncontrolling interests” in the Company’s consolidated balance sheet and “Net loss attributable to the noncontrolling interests” in the Company’s consolidated statement of operations. Prior to its dissolution, Parilis had issued Series A and Series A Hybrid Redeemable Preferred Units (“Preferred Units”) to investors other than Oncobiologics. The Preferred Units were redeemable both at the option of the Parilis Preferred holders and upon the occurrence of an event that was not solely within the Company’s control. Because redemption of Preferred Units was outside of the Company’s control, the noncontrolling interests was presented on the consolidated balance sheet under the caption redeemable noncontrolling interests and was carried at its current redemption value. As of and for the year ended September 30, 2015, the redeemable noncontrolling interests was presented at its carrying amount and adjusted for dividends to and contributions from the noncontrolling interests with an offsetting charge to common stock or, in the absence of common stock, a charge to accumulated deficit. |
Use of estimates | Use of estimates The preparation of the 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 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 consolidated financial statements in the period they are determined to be necessary. |
Recapitalization | Recapitalization On April 26, 2016, the Company filed a certificate of amendment to amend its certificate of incorporation effecting a 1-for-3.45 reverse split of the Company’s common stock. All references in the consolidated financial statements to the number of shares and per-share amounts of common stock have been retroactively restated to reflect the reverse split. |
Restricted cash | Restricted cash As of September 30, 2016 and 2015, the Company had $216,086 and $213,663, respectively, in certificates of deposit related to the requirements of the Company’s bank loans. |
Fair Value of financial instruments | Fair value of financial instruments At September 30, 2016 and 2015, the Company’s financial instruments included accounts payable, accrued expenses, stockholder notes and debt. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments. The stockholder notes and debt approximates fair value as the interest rates are reflective of the rate the Company could obtain on debt with similar terms and conditions. As of September 30, 2015, the carrying value of the stock-based compensation liability was the estimated fair value of the liability (See Note 11). |
Prepaid expenses and other current assets | Prepaid expenses and other current assets As of September 30, 2016 and 2015, the Company had prepaid research and development of $1,979,527 and $355,182, respectively. |
Property and equipment | Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the life of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations. |
Long-lived assets | Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. The Company has not recognized any impairment of long-lived assets. |
Deferred offering costs | Deferred offering costs The Company capitalizes costs that are directly associated with in-process equity financings until such financings are consummated at which time such costs are recorded against the gross proceeds of the offering. |
Stock-based compensation | Stock-based compensation The Company measures equity classified stock-based awards granted to employees and directors based on the estimated fair value on the date of grant and recognizes compensation expense of those awards, net of estimated forfeitures, on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in note 11. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant. Stock-based awards granted to consultants and non-employees are measured based on the fair value of the award on the date on which the related services are completed. Compensation expense is recognized over the period during which services are rendered by such consultants and non-employees until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option-pricing model. Stock-based awards that are settled in cash are accounted for as liabilities and are remeasured at each reporting period until the obligations are satisfied. Stock-based compensation liabilities are valued through the use of a Monte Carlo simulation model. |
Revenue recognition | Revenue recognition The Company’s revenue is generated primarily through collaboration research and license agreements. The terms of these agreements generally contain multiple deliverables which may include (i) licenses, (ii) research and development activities, clinical manufacturing, and (iii) product supply. The payment terms of these agreements may include nonrefundable upfront fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. The Company considers whether the deliverables under the arrangement represent separate units of accounting. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have stand-alone value. The consideration received is allocated to the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company typically receives upfront, nonrefundable payments when licensing its intellectual property. For intellectual property licenses that do not have stand-alone value from the other deliverables to be provided, the upfront fee is deferred and revenue is recognized over the contractual or estimated performance period, which is typically the term of the research and development obligations. The periods over which revenue is recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue. The Company recognizes revenue from milestone payments when: (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement, and (ii) the Company does not have ongoing performance obligations related to the achievement of the milestone earned. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment (a) is commensurate with either the Company’s performance to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the Company’s performance to achieve the milestone, (b) relates solely to past performance, and (c) is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. |
Research and development | Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. |
Income taxes | Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, 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. 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. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. |
Accretion of redeemable preferred stock, redeemable common stock and redeemable noncontrolling interests | Accretion of redeemable preferred stock, redeemable common stock and redeemable noncontrolling interests Accretion of redeemable preferred stock included the accretion of dividends and issuance costs of the Company’s Series A and Series B redeemable preferred stock and the redeemable common stock. The carrying values of the Series A and Series B redeemable preferred stock, redeemable common stock and redeemable noncontrolling interests were being accreted to their respective redemption values, using the effective interest method, from the date of issuance to the earliest date the holders can demand redemption. Increases to the carrying value of redeemable preferred stock, common stock, and noncontrolling interests are charged to common stock or, in the absence of common stock, charged to accumulated deficit. Upon repurchase of redeemable preferred stock and redeemable noncontrolling interests, the excess consideration paid over the carrying value at the time of repurchase was accounted for as a deemed dividends to the preferred stockholders. |
Net loss per share | Net loss per share Basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares during the period. For all periods presented, the outstanding shares of Series A and Series B redeemable preferred stock have been excluded from the calculation because their effects would be anti-dilutive. Therefore the weighted-average shares used to calculate both basic and diluted loss per share are the same. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2016 and 2015, as they would be antidilutive: September 30, 2016 2015 Series A redeemable preferred stock — 1,034,181 Series B redeemable preferred stock — 1,159,418 Performance-based stock units 247,309 — Restricted stock units 1,094,351 — Convertible stockholder note — 96,618 Common stock warrants 8,186,934 — Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Recently issued and adopted accounting pronouncements | Recently issued and adopted accounting pronouncements In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern 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 — assets recognized from the costs to obtain or fulfill a contract. 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 February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting, which is intended to simplify the accounting and reporting for employee share-based payment transactions. The pronouncement is effective for interim and annual periods beginning after December 31, 2016 with early adoption permitted. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. |
Basis of Presentation and Sum23
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Schedule of dilutive securities excluded from the computation weighted-average shares | September 30, 2016 2015 Series A redeemable preferred stock — 1,034,181 Series B redeemable preferred stock — 1,159,418 Performance-based stock units 247,309 — Restricted stock units 1,094,351 — Convertible stockholder note — 96,618 Common stock warrants 8,186,934 — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | September 30, 2015 (Level 1) (Level 2) (Level 3) Liabilities Stock-based compensation liability $ — $ — $ 12,726,722 The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the stock-based compensation liability for the years ended September 30, 2016 and 2015: Balance at October 1, 2014 $ 1,557,789 Change in fair value 11,168,933 Balance at September 30, 2015 12,726,722 Change in fair value 2,391,862 Reclassification to stockholders’ equity (deficit) (15,118,584 ) Balance at September 30, 2016 $ — |
Schedule of fair value of the performance-based stock units (PSUs) | September 30, 2015 Risk-free interest rate 1.4% Derived service period 5 years Expected volatility 60% Annual dividend yield 0% Fair value of common stock $25.79 per share |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | September 30, 2016 2015 Laboratory equipment $ 11,452,858 $ 10,936,364 Leasehold improvements 10,031,739 9,889,521 Computer software and hardware 421,206 402,075 Construction in progress 1,014,690 175,425 22,920,493 21,403,385 Less: accumulated depreciation and amortization (5,961,940 ) (3,643,447 ) $ 16,958,553 $ 17,759,938 |
Schedule of future minimum lease payments under capital leases | 2017 $ 1,093,624 2018 341,740 1,435,364 Less: amounts representing interest (137,379 ) Less: current portion (977,248 ) Capital lease obligations, excluding current portion $ 320,737 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Accrued Expenses [Abstract] | |
Schedule of accrued expenses | September 30, 2016 2015 Compensation $ 3,884,386 $ 2,321,508 Research and development 1,343,910 951,759 Interest payable 234,754 806,475 Deferred offering costs 26,028 657,892 Professional fees 486,705 594,572 Director fees 73,125 414,421 Other accrued expenses 73,034 178,021 $ 6,121,942 $ 5,924,648 |
Stockholder Notes (Tables)
Stockholder Notes (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Short-term Debt [Abstract] | |
Schedule of stockholder equity | September 30, 2016 2015 Series A repurchase notes $ — $ 800,534 Parilis Series A repurchase notes — 2,275,818 Restricted stock repurchase notes 800,000 1,097,750 Common stock repurchase note 2,812,500 2,812,500 Convertible note — 2,000,000 Working capital notes 1,000,000 7,227,594 4,612,500 16,214,196 Less: current portion (4,612,500 ) (14,214,196 ) $ — $ 2,000,000 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of debt | September 30, 2016 2015 Term loans-Bank $ 2,526,502 $ 3,404,759 Equipment loans 354,979 334,093 Unamortized debt discount (61,224 ) (73,442 ) 2,820,257 3,665,410 Less: current portion (586,454 ) (742,646 ) Long-term debt $ 2,233,803 $ 2,922,764 |
Schedule of future maturities of debt | 2017 $ 586,454 2018 515,793 2019 549,694 2020 569,142 2021 497,491 Thereafter 162,907 $ 2,881,481 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments in operating leases | 2017 $ 1,551,513 2018 1,735,263 2019 1,753,323 2020 1,771,545 2021 1,596,976 Thereafter 3,541,990 $ 11,950,610 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of stock-based compensation expense | Year ended September 30, 2016 2015 Research and development $ 2,044,379 $ 5,817,830 General and administrative 10,405,700 5,360,028 $ 12,450,079 $ 11,177,858 Year ended September 30, 2016 2015 Equity-classified compensation $ 10,058,217 $ 8,925 Liability-classified compensation 2,391,862 11,168,933 $ 12,450,079 $ 11,177,858 |
Schedule of performance-based stock units activity | Number of Base Price Per Balance at October 1, 2014 658,498 $ 3.45 Granted 39,988 3.45 Forfeitures (11,473 ) 3.45 Balance at October 1, 2015 687,013 3.45 Forfeitures (4,924 ) 4.85 Exchanged for restricted stock units (434,780 ) 3.45 Balance at September 30, 2016 247,309 $ 6.33 |
Schedule of fair value of the PSU | December 31, 2015 Risk-free interest rate 1.0% Derived service period 2.3 years Expected volatility 57.6% Annual dividend yield 0% Fair value of common stock $29.05 per share |
Schedule of restricted stock units activity | Number of Weighted Balance at October 1, 2015 — $ — Granted 705,311 28.31 Forfeitures (2,263 ) 13.78 Issued in connection with PSU exchange 391,303 29.05 Balance at September 30, 2016 1,094,351 $ 28.61 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of income tax expense (benefit) | Year Ended September 30, 2016 2015 State tax, including sale of New Jersey losses and credits $ 3,000 $ (725,969 ) Foreign tax provision 100,000 535,858 $ 103,000 $ (190,111 ) |
Schedule of reconciliation of income tax expense (benefit) at the statutory income tax rate | Year Ended September 30, 2016 2015 U.S. federal statutory rate (34.0 )% (34.0 )% State taxes, net of federal benefit (5.9 ) (5.5 ) Foreign withholding tax 0.2 1.1 Permanent differences — 1.8 Foreign tax credits — (1.1 ) Research and development credit — (6.9 ) Change in valuation allowance 40.0 44.6 Other (0.1 ) (0.4 ) Effective income tax rate 0.2 % (0.4 )% |
Schedule of deferred taxes | Year Ended September 30, 2016 2015 Deferred tax assets Net operating loss carryforwards $ 36,146,789 $ 20,164,392 Stock compensation 11,249,314 6,317,492 Deferred revenue 2,542,558 3,333,201 Research and development credit carryforward 757,701 5,979,964 Foreign tax credits 2,257,309 2,602,949 Accruals and others 1,287,592 1,072,422 Gross deferred tax assets 54,241,263 39,470,420 Less: valuation allowance (52,737,104 ) (38,694,795 ) 1,504,159 775,625 Deferred tax liability: Fixed assets (1,504,159 ) (775,625 ) Net deferred tax assets $ — $ — |
Schedule of reconciliation of unrecognized tax benefits | Year Ended September 30, 2016 2015 Balance at beginning of year $ 1,754,629 $ 1,564,411 Additions based on tax positions related to the current year 100,000 190,218 Balance at end of year 1,854,629 1,754,629 |
Organization and Description of
Organization and Description of Business (Detail Textuals) - USD ($) | May 13, 2016 | May 31, 2016 | May 18, 2016 | Oct. 31, 2015 | Sep. 30, 2016 | Sep. 30, 2015 |
Organization And Description Of Business [Line Items] | ||||||
Basis of conversion | 1-for-1 basis | |||||
Number of unit issued by securities offering | $ 16,137,913 | $ 44,142,463 | ||||
Exercise price per share | $ 0.01 | |||||
Gross proceeds of private placement and warrants | $ 5,000,000 | $ 401,000 | ||||
Proceeds from sale of common stock units in connection with initial public offering and private placement | $ 37,074,996 | |||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||
Common stock, shares authorized | 200,000,000 | 100,000,000 | ||||
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 | ||||
Common stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 | ||||
Common stock repurchase note | ||||||
Organization And Description Of Business [Line Items] | ||||||
Number of unit issued by securities offering | $ 5,734 | $ 44,142,463 | ||||
Additional share of common stock | 573,388 | 1,765,511 | ||||
Series A warrant | ||||||
Organization And Description Of Business [Line Items] | ||||||
Additional share of common stock | 416,666 | |||||
Exercise price per share | $ 6.60 | $ 6.60 | ||||
Series B warrant | ||||||
Organization And Description Of Business [Line Items] | ||||||
Additional share of common stock | 416,666 | |||||
Exercise price per share | $ 8.50 | $ 8.50 | ||||
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. | |||||
Number of unit issued by securities offering | $ 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 | |||||
Private Placement | ||||||
Organization And Description Of Business [Line Items] | ||||||
Additional share of common stock | 833,332 | |||||
Private Placement | Series A warrant | ||||||
Organization And Description Of Business [Line Items] | ||||||
Additional share of common stock | 416,666 | |||||
Exercise price per share | $ 6.60 | |||||
Private Placement | Series B warrant | ||||||
Organization And Description Of Business [Line Items] | ||||||
Additional share of common stock | 416,666 | |||||
Exercise price per share | $ 8.50 | |||||
Initial Public Offering And Private Placement | ||||||
Organization And Description Of Business [Line Items] | ||||||
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 | |||||
Parilis Biopharmaceuticals ("Parilis") | ||||||
Organization And Description Of Business [Line Items] | ||||||
Conversion of stock number of common stock issued | 226,663 | |||||
Series A redeemable preferred stock | ||||||
Organization And Description Of Business [Line Items] | ||||||
Conversion of stock number of common stock issued | 289 | |||||
Conversion of stock shares, preferred stock shares issued | $ 1.4035 | |||||
Series A redeemable preferred stock | Holders of Series A and B preferred stock | ||||||
Organization And Description Of Business [Line Items] | ||||||
Conversion of stock, number of preferred stock issued | 10,193 | |||||
Series A redeemable preferred stock | Parilis Biopharmaceuticals ("Parilis") | ||||||
Organization And Description Of Business [Line Items] | ||||||
Conversion of stock, number of preferred stock issued | 1,626 | |||||
Series B redeemable preferred stock | ||||||
Organization And Description Of Business [Line Items] | ||||||
Conversion of stock number of common stock issued | 289 | |||||
Conversion of stock shares, preferred stock shares issued | $ 1.2867 |
Liquidity (Detail Textuals)
Liquidity (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Dec. 23, 2016 | May 18, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | |
Liquidity [Line Items] | ||||
Net proceeds initial public offering | $ 37,074,996 | |||
Accumulated deficit | (147,393,548) | $ (94,064,286) | ||
Aggregate indebtedness | 4,600,000 | |||
Notes payable to stockholders | 4,612,500 | 16,214,196 | ||
Proceeds from issuance of notes | 10,880,252 | |||
Repayment of senior secured bank loans | $ 1,059,034 | $ 725,598 | ||
Subsequent Event | ||||
Liquidity [Line Items] | ||||
Proceeds from issuance of notes | $ 8,350,000 | |||
Repayment of senior secured bank loans | $ 2,400,000 | |||
IPO | ||||
Liquidity [Line Items] | ||||
Net proceeds initial public offering | $ 33,800,000 |
Basis of Presentation and Sum34
Basis of Presentation and Summary of Significant Accounting Policies (Details) - shares | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Series A redeemable preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,034,181 | |
Series B redeemable preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,159,418 | |
Performance-based stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 247,309 | |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,094,351 | |
Convertible stockholder note | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 96,618 | |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 8,186,934 |
Basis of Presentation and Sum35
Basis of Presentation and Summary of Significant Accounting Policies (Detail Textuals) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Accounting Policies [Abstract] | ||
Reverse split | 1-for-3.45 | |
Restricted Cash | $ 216,086 | $ 213,663 |
Prepaid research and development | $ 1,979,527 | $ 355,182 |
Estimated useful lives | 3 to 10 years | |
Methods of depreciation and amortization | Straight-line |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Fair value measurements recurring basis | Sep. 30, 2015USD ($) |
Level 1 | |
Liabilities | |
Stock-based compensation liability | |
Level 2 | |
Liabilities | |
Stock-based compensation liability | |
Level 3 | |
Liabilities | |
Stock-based compensation liability | $ 12,726,722 |
Fair Value Measurements (Deta37
Fair Value Measurements (Details 1) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance | $ 12,726,722 | $ 1,557,789 |
Change in fair value | 2,391,862 | 11,168,933 |
Reclassification to stockholders' equity (deficit) | (15,118,584) | |
Balance | $ 12,726,722 |
Fair Value Measurements (Deta38
Fair Value Measurements (Details 2) - Stock-based performance units ("PSUs"), | 12 Months Ended |
Sep. 30, 2015$ / shares | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Risk-free interest rate | 1.40% |
Derived service period | 5 years |
Expected volatility | 60.00% |
Annual dividend yield | 0.00% |
Fair value of common stock | $ 25.79 |
Fair Value Measurements (Deta39
Fair Value Measurements (Detail Textuals) - Stock-based performance units ("PSUs"), - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
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 | excess of $400 million | ||
Method used for cost of award | Monte Carlo simulation model | ||
Share price | $ 25.74 | $ 22.22 | |
Market value of exercisability awards | $ 400 | ||
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% |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 22,920,493 | $ 21,403,385 |
Less: accumulated depreciation and amortization | (5,961,940) | (3,643,447) |
Property and equipment, net | 16,958,553 | 17,759,938 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 11,452,858 | 10,936,364 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 10,031,739 | 9,889,521 |
Computer software and hardware | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 421,206 | 402,075 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,014,690 | $ 175,425 |
Property and Equipment (Detai41
Property and Equipment (Details 1) - USD ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Property, Plant and Equipment [Abstract] | ||
2,017 | $ 1,093,624 | |
2,018 | 341,740 | |
Total future minimum lease payments under capital leases | 1,435,364 | |
Less: amounts representing interest | (137,379) | |
Less: current portion | (977,248) | $ (862,849) |
Capital lease obligations, excluding current portion | $ 320,737 | $ 1,219,373 |
Property and Equipment (Detail
Property and Equipment (Detail Textuals) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization expense | $ 2,394,279 | $ 1,824,600 |
Accumulated depreciation related to leased equipment | 732,002 | 407,210 |
Laboratory Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Laboratory equipment under capital leases | $ 3,630,683 | $ 3,530,301 |
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 ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Accrued Liabilities, Current [Abstract] | ||
Compensation | $ 3,884,386 | $ 2,321,508 |
Research and development | 1,343,910 | 951,759 |
Interest payable | 234,754 | 806,475 |
Deferred offering costs | 26,028 | 657,892 |
Professional fees | 486,705 | 594,572 |
Director fees | 73,125 | 414,421 |
Other accrued expenses | 73,034 | 178,021 |
Accrued expenses | $ 6,121,942 | $ 5,924,648 |
Stockholder Notes (Details)
Stockholder Notes (Details) - USD ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Stockholder Notes [Line Items] | ||
Stockholder notes | $ 4,612,500 | $ 16,214,196 |
Less: current portion | (4,612,500) | (14,214,196) |
Long-tem stockholder notes | 2,000,000 | |
Series A repurchase notes | ||
Stockholder Notes [Line Items] | ||
Stockholder notes | 800,534 | |
Parilis Series A repurchase notes | ||
Stockholder Notes [Line Items] | ||
Stockholder notes | 2,275,818 | |
Restricted stock repurchase notes | ||
Stockholder Notes [Line Items] | ||
Stockholder notes | 800,000 | 1,097,750 |
Common stock repurchase note | ||
Stockholder Notes [Line Items] | ||
Stockholder notes | 2,812,500 | 2,812,500 |
Convertible note | ||
Stockholder Notes [Line Items] | ||
Stockholder notes | 2,000,000 | |
Working capital notes | ||
Stockholder Notes [Line Items] | ||
Stockholder notes | $ 1,000,000 | $ 7,227,594 |
Stockholder Notes (Detail Textu
Stockholder Notes (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2014 | Oct. 31, 2014 | Jun. 30, 2014 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stockholder Notes [Line Items] | |||||
Repayment of stockholder notes | $ 11,601,696 | $ 7,888,658 | |||
Interest expense related to the stockholder notes | 589,675 | 1,869,113 | |||
Stockholder notes | $ 4,612,500 | 16,214,196 | |||
Series A redeemable preferred stock | |||||
Stockholder Notes [Line Items] | |||||
Notes issued | $ 3,364,534 | ||||
Interest rate | 4.00% | 4.00% | |||
Notes offset against collateral | 64,000 | ||||
Principal payments of notes | $ 800,534 | 2,050,000 | |||
Stockholder notes | 800,534 | ||||
Series A redeemable preferred stock | Investors | |||||
Stockholder Notes [Line Items] | |||||
Notes issued | $ 3,364,534 | ||||
Notes offset against collateral | 100,000 | ||||
Series A redeemable preferred stock | CEO | |||||
Stockholder Notes [Line Items] | |||||
Notes offset against collateral | 64,000 | ||||
Parilis Series A repurchase notes | |||||
Stockholder Notes [Line Items] | |||||
Notes issued | $ 2,761,818 | ||||
Cumulative unpaid dividends | $ 331,818 | ||||
Principal payments of notes | 2,275,818 | 486,000 | |||
Number of unit repurchase | 1,215 | ||||
Preferred stock price per units | $ 2,000 | ||||
Stockholder notes | 2,275,818 | ||||
Restricted stock repurchase notes | |||||
Stockholder Notes [Line Items] | |||||
Repayment of stockholder notes | 297,750 | ||||
Repurchase of restricted stock in exchange for notes payable | $ 1,097,750 | ||||
Stockholder notes | 800,000 | 1,097,750 | |||
Restricted stock repurchase notes | Minimum | |||||
Stockholder Notes [Line Items] | |||||
Interest rate | 0.00% | ||||
Restricted stock repurchase notes | Maximum | |||||
Stockholder Notes [Line Items] | |||||
Interest rate | 4.00% | ||||
Common stock repurchase note | |||||
Stockholder Notes [Line Items] | |||||
Interest rate | 12.00% | 12.00% | |||
Repurchase of restricted stock in exchange for notes payable | $ 2,000,000 | $ 2,000,000 | |||
Stockholder notes | 2,812,500 | 2,812,500 | |||
Convertible note | |||||
Stockholder Notes [Line Items] | |||||
Stockholder notes | 2,000,000 | ||||
Working capital notes | |||||
Stockholder Notes [Line Items] | |||||
Note collateralized by common shares | 300,000 | ||||
Stockholder notes | $ 1,000,000 | $ 7,227,594 | |||
Working capital notes | Minimum | |||||
Stockholder Notes [Line Items] | |||||
Interest rate | 0.00% | ||||
Working capital notes | Maximum | |||||
Stockholder Notes [Line Items] | |||||
Interest rate | 30.00% |
Debt (Details)
Debt (Details) - USD ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Debt Disclosure [Abstract] | ||
Term loans-Bank | $ 2,526,502 | $ 3,404,759 |
Equipment loans | 354,979 | 334,093 |
Unamortized debt discount | (61,224) | (73,442) |
Total loans payable | 2,820,257 | 3,665,410 |
Less: current portion | (586,454) | (742,646) |
Loans payable, noncurrent | $ 2,233,803 | $ 2,922,764 |
Debt (Details 1)
Debt (Details 1) - USD ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Debt Disclosure [Abstract] | ||
2,017 | $ 586,454 | |
2,018 | 515,793 | |
2,019 | 549,694 | |
2,020 | 569,142 | |
2,021 | 497,491 | |
Thereafter | 162,907 | |
Total debt | $ 2,881,481 | $ 2,922,764 |
Debt (Detail Textuals)
Debt (Detail Textuals) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Debt Instrument [Line Items] | ||
Interest expense | $ 230,824 | $ 287,280 |
Loans payable to bank | ||
Debt Instrument [Line Items] | ||
Debt instrument, frequency of periodic payment | Monthly | |
Payments of principal and interest | $ 48,048 | |
Debt instrument, description of collateral | Collateralized by equipment, a secured interest in the personal residence of the founding stockholder and CEO, an unconditional personal guarantee by the founding stockholder and CEO and a $200,000 certificate of deposit. | |
Loans payable to bank | Maximum | ||
Debt Instrument [Line Items] | ||
Debt Instrument, term | 10 years | |
Loans payable to bank | Minimum | ||
Debt Instrument [Line Items] | ||
Debt Instrument, term | 7 years | |
Loans payable to bank | Prime rate | ||
Debt Instrument [Line Items] | ||
Debt, interest rate | 2.75% | |
Equipment loan | ||
Debt Instrument [Line Items] | ||
Debt instrument, frequency of periodic payment | Monthly | |
Payments of principal and interest | $ 19,379 | |
Debt instrument, description of collateral | Collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and CEO. | |
Equipment loan | Maximum | ||
Debt Instrument [Line Items] | ||
Debt, interest rate | 16.00% | |
Debt Instrument, term | 5 years | |
Equipment loan | Minimum | ||
Debt Instrument [Line Items] | ||
Debt, interest rate | 12.00% | |
Debt Instrument, term | 1 year |
Commitments (Details)
Commitments (Details) | Sep. 30, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,017 | $ 1,551,513 |
2,018 | 1,735,263 |
2,019 | 1,753,323 |
2,020 | 1,771,545 |
2,021 | 1,596,976 |
Thereafter | 3,541,990 |
Future minimum rental payments under noncancelable operating eases | $ 11,950,610 |
Commitments (Detail Textuals)
Commitments (Detail Textuals) | 1 Months Ended | 12 Months Ended | ||
Jul. 30, 2016 | Aug. 31, 2015ft² | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | |
Long-term Purchase Commitment [Line Items] | ||||
Rent expense under the leases | $ 1,619,019 | $ 720,875 | ||
Defined contribution plan, maximum annual contributions per employee, percent | 100.00% | |||
Defined contribution plan, employer matching contribution, percent of match | 100.00% | |||
Description of defined contribution plan | The Company matches 100% of the first 3% of employee contributions. | |||
Expense related to matching contribution | $ 191,097 | $ 131,385 | ||
Office and operating space | ||||
Long-term Purchase Commitment [Line Items] | ||||
Description of Lessee Leasing Arrangements, Operating Leases | Term ending in June 2021. | |||
Office and laboratory space | ||||
Long-term Purchase Commitment [Line Items] | ||||
Description of Lessee Leasing Arrangements, Operating Leases | Expire in March 2026 | |||
Net Rentable Area | ft² | 82,000 | |||
Technology License | ||||
Long-term Purchase Commitment [Line Items] | ||||
Long-term Purchase Commitment, Amount | $ 376,000 |
Redeemable Preferred Stock, C51
Redeemable Preferred Stock, Common Stock, Noncontrolling Interests and Stockholders' Equity (Deficit) (Detail Textuals) - USD ($) | 1 Months Ended | 4 Months Ended | 12 Months Ended | |
May 31, 2016 | Jan. 31, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stockholders Equity [Line Items] | ||||
Shares issued, price per share | $ 25.79 | |||
Proceeds from the sale of common stock | $ 16,137,913 | $ 41,249,998 | ||
Stock issued during period, value | 16,137,913 | $ 44,142,463 | ||
Proceeds from subscriptions receivable | $ 4,280,149 | |||
Redeemable stock, shares issued | 0 | 1,739,130 | ||
Series A warrant | ||||
Stockholders Equity [Line Items] | ||||
Shares issued during period | 416,666 | |||
Series B warrant | ||||
Stockholders Equity [Line Items] | ||||
Shares issued during period | 416,666 | |||
IPO and private placement | ||||
Stockholders Equity [Line Items] | ||||
Shares issued during period | 5,833,334 | |||
Shares issued, price per share | $ 6 | |||
Proceeds from the sale of common stock | $ 33,784,205 | |||
Sonnet | ||||
Stockholders Equity [Line Items] | ||||
Promissory note amount | $ 826,561 | |||
Common stock | ||||
Stockholders Equity [Line Items] | ||||
Shares issued during period | 573,388 | 1,765,511 | ||
Shares issued, price per share | $ 29.05 | $ 25.79 | ||
Proceeds from the sale of common stock | $ 16,137,913 | |||
Stock issued during period, value | $ 5,734 | $ 44,142,463 | ||
Conversion of Series A preferred stock in common stock | 1,969,818 | |||
Common stock | IPO and private placement | ||||
Stockholders Equity [Line Items] | ||||
Shares issued during period | 833,332 |
Redeemable Preferred Stock, C52
Redeemable Preferred Stock, Common Stock, Noncontrolling Interests and Stockholders' Equity (Deficit) (Detail Textuals 1) - USD ($) | 1 Months Ended | 12 Months Ended |
May 31, 2016 | Sep. 30, 2016 | |
Stockholders Equity [Line Items] | ||
Exercise price per share | $ 0.01 | |
Outstanding warrants | 7,373,820 | |
Number of common stock called by warrants | 1,520,268 | |
Other common stock warrants description | In May 2016, upon the closing of the IPO, the Company issued warrants to acquire an aggregate of 1,520,268 shares of its common stock to certain of the investors party to that certain investors’ rights agreement dated March 10, 2014, as amended, pursuant to the terms of an amendment to such agreement dated April 26, 2016. The warrants issued to these investors are not exercisable until 180 days after May 12, 2016, and have an initial exercise price of $0.01 per share, which may increase to $1.00 per share under certain circumstances, and expire November 18, 2019. | |
Deemed dividend upon issuance of warrants to common stockholders | $ 7,373,820 | |
Series A warrant | ||
Stockholders Equity [Line Items] | ||
Exercise price per share | $ 6.60 | $ 6.60 |
Outstanding warrants | 3,333,333 | |
Series B warrant | ||
Stockholders Equity [Line Items] | ||
Exercise price per share | $ 8.50 | $ 8.50 |
Outstanding warrants | 3,333,333 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - 2015 Equity Incentive Plan - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 12,450,079 | $ 11,177,858 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 2,044,379 | 5,817,830 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 10,405,700 | $ 5,360,028 |
Stock Based Compensation (Det54
Stock Based Compensation (Details 1) - 2015 Equity Incentive Plan - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 12,450,079 | $ 11,177,858 |
Equity-classified compensation | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 10,058,217 | 8,925 |
Liability-classified compensation | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 2,391,862 | $ 11,168,933 |
Stock Based Compensation (Det55
Stock Based Compensation (Details 2) - Performance-based stock units - $ / shares | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Number of PSUs | ||
Balance at October 1 | 687,013 | 658,498 |
Granted | 39,988 | |
Forfeitures | (4,924) | (11,473) |
Exchanged for restricted stock units | (434,780) | |
Balance at September 30 | 247,309 | 687,013 |
Base Price Per PSU | ||
Balance at October 1 | $ 3.45 | $ 3.45 |
Granted | 3.45 | |
Forfeitures | 4.85 | 3.45 |
Exchanged for restricted stock units | 3.45 | |
Balance at September 30 | $ 6.33 | $ 3.45 |
Stock Based Compensation (Det56
Stock Based Compensation (Details 3) - Performance-based stock units | 3 Months Ended |
Dec. 31, 2015$ / shares | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Risk-free interest rate | 1.00% |
Derived service period | 2 years 3 months 18 days |
Expected volatility | 57.60% |
Annual dividend yield | 0.00% |
Fair value of common stock per share | $ 29.05 |
Stock Based Compensation (Det57
Stock Based Compensation (Details 4) - Restricted stock units | 12 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Number of RSUs | |
Balance at October 1 | shares | |
Granted | shares | 705,311 |
Forfeitures | shares | (2,263) |
Issued in connection with PSU exchange | shares | 391,303 |
Balance at September 30 | shares | 1,094,351 |
Weighted Average Grant Date Fair Value | |
Balance at October 1 | $ / shares | |
Granted | $ / shares | 28.31 |
Forfeitures | $ / shares | 13.78 |
Issued in connection with PSU exchange | $ / shares | 29.05 |
Balance at September 30 | $ / shares | $ 28.61 |
Stock Based Compensation (Det58
Stock Based Compensation (Detail Textuals) - shares | Sep. 30, 2016 | Sep. 30, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock, shares, outstanding | 22,802,778 | 9,436,294 |
2011 Equity Incentive Plan | Officers, Employees, Consultants and Directors | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares of common stock reserved for issuance | 1,159,420 | |
Common stock, shares, outstanding | 247,309 |
Stock Based Compensation (Det59
Stock Based Compensation (Detail Textuals 1) - shares | Jul. 11, 2016 | Sep. 30, 2016 | Sep. 30, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock, shares, outstanding | 22,802,778 | 9,436,294 | |
2015 Equity Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum number of shares can be issued | 1,930,460 | ||
Maximum number of shares increased | 684,083 | ||
Percentage of outstanding common stock increased | 3.00% | ||
2015 Equity Incentive Plan | Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock, shares, outstanding | 1,094,351 | ||
Number of shares available for grant | 836,109 |
Stock Based Compensation (Det60
Stock Based Compensation (Detail Textuals 2) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Additional stock-based compensation as result of modification | $ 98,172 | ||
Performance-based stock units | |||
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 | excess of $400 million | ||
Number of PSU exchanged for RSU | 434,780 | ||
Share price | $ 25.74 | $ 22.22 | |
Unamortized expense | $ 646,531 | ||
Period for recognition of unamortized expense | 1 year 8 months 16 days | ||
Performance-based stock units | After third anniversary from issuance of stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting percentage | 50.00% | ||
Performance-based stock units | Fourth anniversary | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting percentage | 50.00% | ||
Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of RSU issued in connection with PSU | 391,303 | ||
Unamortized expense | $ 12,527,573 | ||
Period for recognition of unamortized expense | 1 year 6 months 11 days | ||
Restricted stock units | After third anniversary from issuance of stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting percentage | 50.00% |
Stock Based Compensation (Det61
Stock Based Compensation (Detail Textuals 3) - Restricted stock units | 12 Months Ended |
Sep. 30, 2016USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unamortized expense | $ | $ 12,527,573 |
Period for recognition of unamortized expense | 1 year 6 months 11 days |
IPO | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares vested in period | 387,868 |
Remaining number of shares vested in period | 708,303 |
Vesting on each of first and second anniversaries of recipient's grant date | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares vested in period | 525,999 |
Vesting percentage | 50.00% |
One-third vesting on each of first, second, and third anniversaries of recipient's hire date | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares vested in period | 21,738 |
Description of vesting percentage | one-third vesting |
Vesting on each of third and fourth anniversaries of recipient's hire date | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares vested in period | 160,566 |
Vesting percentage | 50.00% |
Collaboration Arrangements (Det
Collaboration Arrangements (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jun. 30, 2014 | Aug. 31, 2013 | May 31, 2013 | Sep. 30, 2016 | Sep. 30, 2015 | |
Huahai agreement | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Revenue reorganization deferred revenue | $ 1,175,580 | $ 881,685 | |||
Deferred revenue | 3,752,950 | 4,928,530 | |||
Huahai agreement | Substantive milestones | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Milestone payments received | $ 8,500,000 | ||||
Revenue reorganization deferred revenue | 2,000,000 | ||||
Huahai agreement | Non-substantive milestones | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Milestone payments received | $ 7,500,000 | ||||
IPCA License and Collaboration Agreement | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Revenue reorganization deferred revenue | 421,732 | 402,377 | |||
Deferred revenue | 1,370,630 | 1,792,362 | |||
IPCA License and Collaboration Agreement | Substantive milestones | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Milestone payments received | $ 1,000,000 | ||||
Revenue reorganization deferred revenue | 500,000 | ||||
IPCA License and Collaboration Agreement | Non-substantive milestones | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Milestone payments received | $ 2,400,000 | ||||
Strategic Collaboration and Non-Exclusive License Agreement | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Revenue reorganization deferred revenue | 0 | 800,000 | |||
Liomont agreement | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Milestone payments received | $ 2,000,000 | ||||
Revenue reorganization deferred revenue | 382,264 | 341,280 | |||
Deferred revenue | $ 1,242,365 | $ 1,624,629 | |||
Liomont agreement | Substantive milestones | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Milestone payments received | 2,000,000 | ||||
Liomont agreement | Non-substantive milestones | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Milestone payments received | $ 1,000,000 |
Related-Party Transactions (Det
Related-Party Transactions (Detail Textuals) | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2015USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($)Directorshares | Sep. 30, 2014USD ($)shares | |
Related Party Transaction [Line Items] | ||||
Loan from director | $ 826,561 | |||
CEO | ||||
Related Party Transaction [Line Items] | ||||
Non interest bearing advances | $ 783,707 | |||
Repayment of advances | 395,257 | |||
Accrued compensation payments | $ 117,506 | |||
Director | ||||
Related Party Transaction [Line Items] | ||||
Loan from director | $ 1,000,000 | |||
Interest rate | 24.00% | 4.00% | ||
Accrued interest | $ 128,219 | |||
Number of directors | Director | 3 | |||
Aggregate payment to preferred stockholder | $ 650,000 | |||
Issuance of stockholder notes | $ 1,850,000 | |||
Percentage of increase in interest rate | 6.00% | |||
Director | Series A redeemable preferred stock | ||||
Related Party Transaction [Line Items] | ||||
Repurchase of shares | shares | 1,250 | 1,250 | ||
Accrued dividends | $ 326,354 | $ 326,354 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Income Tax Disclosure [Abstract] | ||
State tax, including sale of New Jersey losses and credits | $ 3,000 | $ (725,969) |
Foreign tax provision | 100,000 | 535,858 |
Income tax expense (benefit) | $ 103,000 | $ (190,111) |
Income Taxes (Details 1)
Income Taxes (Details 1) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal statutory rate | (34.00%) | (34.00%) |
State taxes, net of federal benefit | (5.90%) | (5.50%) |
Foreign withholding tax | 0.20% | 1.10% |
Permanent differences | 1.80% | |
Foreign tax credits | (1.10%) | |
Research and development credit | (6.90%) | |
Change in valuation allowance | 40.00% | 44.60% |
Other | (0.10%) | (0.40%) |
Effective income tax rate | 0.20% | (0.40%) |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) | Sep. 30, 2016 | Sep. 30, 2015 |
Deferred tax assets | ||
Net operating loss carryforwards | $ 36,146,789 | $ 20,164,392 |
Stock compensation | 11,249,314 | 6,317,492 |
Deferred revenue | 2,542,558 | 3,333,201 |
Research and development credit carryforward | 757,701 | 5,979,964 |
Foreign tax credits | 2,257,309 | 2,602,949 |
Accruals and others | 1,287,592 | 1,072,422 |
Gross deferred tax assets | 54,241,263 | 39,470,420 |
Less: valuation allowance | (52,737,104) | (38,694,795) |
Deferred tax assets net of valuation allowance | 1,504,159 | 775,625 |
Deferred tax liability: | ||
Fixed assets | (1,504,159) | (775,625) |
Net deferred tax assets |
Income Taxes (Details 3)
Income Taxes (Details 3) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 1,754,629 | $ 1,564,411 |
Additions based on tax positions related to the current year | 100,000 | 190,218 |
Balance at end of year | $ 1,854,629 | $ 1,754,629 |
Income Taxes (Detail Textuals)
Income Taxes (Detail Textuals) - USD ($) | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating Loss Carryforwards [Line Items] | ||
Foreign withholding taxes | $ 100,000 | $ 535,858 |
Research and development tax credit carryforwards | 757,701 | 5,979,964 |
Foreign tax credit carryforwards | 2,257,309 | 2,602,949 |
Increased in valuation allowance | 14,000,000 | 21,300,000 |
New Jersey | ||
Operating Loss Carryforwards [Line Items] | ||
Receive cash from sale of net operating losses | $ 700,000 | |
Net operating losses | 37,000,000 | |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | 99,800,000 | |
Research and development tax credit carryforwards | 800,000 | |
Foreign tax credit carryforwards | 2,300,000 | |
Foreign tax credit carryforward included in unrecognized tax benefit | 1,800,000 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credit carryforwards | $ 800,000 |
Subsequent Events (Detail Textu
Subsequent Events (Detail Textuals) - USD ($) | Dec. 15, 2016 | Dec. 23, 2016 | Dec. 22, 2016 | Dec. 16, 2016 | Dec. 31, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | May 31, 2016 |
Subsequent Event [Line Items] | ||||||||
Warrants to acquire common stock | 1,520,268 | |||||||
Exercise price per share | $ 0.01 | |||||||
Aggregate principal amount of notes and warrants issued | $ 10,880,252 | |||||||
Repayment of senior secured bank loans | $ 1,059,034 | $ 725,598 | ||||||
Loans payable to bank | Maximum | ||||||||
Subsequent Event [Line Items] | ||||||||
Debt Instrument, term | 10 years | |||||||
Subsequent event | ||||||||
Subsequent Event [Line Items] | ||||||||
Amount of notes to be issued | $ 1,920,500 | |||||||
Warrants to acquire common stock | 379,500 | |||||||
Aggregate principal amount of notes and warrants issued | $ 8,350,000 | |||||||
Repayment of senior secured bank loans | $ 2,400,000 | |||||||
Subsequent event | Bridge note | ||||||||
Subsequent Event [Line Items] | ||||||||
Unsecured bridge notes | $ 1,850,000 | |||||||
Interest rate | 15.00% | |||||||
Debt Instrument, term | 1 year | |||||||
Subsequent event | Senior note | ||||||||
Subsequent Event [Line Items] | ||||||||
Interest rate | 5.00% | |||||||
Senior secured promissory note | ||||||||
Debt instrument, maturity date | Dec. 14, 2017 | |||||||
Proceeds from issuance of secured debt | $ 6,500,000 | |||||||
Repayment of unsecured debt | $ 1,850,000 | |||||||
Amount of notes to be issued | $ 6,650,000 | |||||||
Warrants to acquire common stock | 2,300,000 | |||||||
Exercise price per share | $ 3 | |||||||
Term of warrants | 5 years | |||||||
Subsequent event | Senior note | Maximum | ||||||||
Subsequent Event [Line Items] | ||||||||
Senior secured promissory note | $ 10,000,000 |