Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2017 | Dec. 27, 2017 | Mar. 31, 2017 | |
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 | 25,530,727 | ||
Entity Public Float | $ 44.5 | ||
Document Type | 10-K | ||
Document Period End Date | Sep. 30, 2017 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Current assets: | ||
Cash | $ 3,185,519 | $ 2,351,887 |
Prepaid and other current assets | 719,087 | 3,326,607 |
Total current assets | 3,904,606 | 5,678,494 |
Property and equipment, net | 16,088,902 | 18,658,553 |
Restricted cash | 216,086 | |
Other assets | 740,362 | 852,801 |
Total assets | 20,733,870 | 25,405,934 |
Current liabilities: | ||
Current portion of long-term debt | 52,600 | 586,454 |
Current portion of capital lease obligations | 341,120 | 977,248 |
Stockholder notes | 4,612,500 | 4,612,500 |
Accounts payable | 10,954,358 | 5,071,520 |
Accrued expenses | 7,337,469 | 6,121,942 |
Income taxes payable | 2,352,129 | 1,854,629 |
Deferred revenue | 3,087,561 | 1,212,561 |
Total current liabilities | 28,737,737 | 20,436,854 |
Senior secured notes | 13,231,700 | |
Long-term debt | 151,110 | 2,233,803 |
Capital lease obligations | 28,067 | 320,737 |
Warrant liability | 2,274,954 | |
Deferred revenue | 4,466,865 | 5,153,384 |
Other liabilities | 2,569,971 | 2,434,061 |
Total liabilities | 51,460,404 | 30,578,839 |
Commitments (Note 9) | ||
Convertible preferred stock: | ||
Total convertible preferred stock | 2,924,441 | |
Stockholders' equity (deficit): | ||
Series A preferred stock, par value $0.01 per share: 10,000,000 shares authorized, no shares issued and outstanding | ||
Common stock, par value $0.01 per share; 200,000,000 shares authorized; 24,933,944 and 22,802,778 shares issued and outstanding at September 30, 2017 and 2016, respectively | 249,339 | 228,028 |
Additional paid-in capital | 152,315,088 | 141,965,342 |
Accumulated deficit | (186,215,402) | (147,366,275) |
Total stockholders' equity (deficit) | (33,650,975) | (5,172,905) |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | 20,733,870 | 25,405,934 |
Series A Convertible Preferred Stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | 2,924,441 | 0 |
Series B Convertible Preferred Stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2017 | Sep. 30, 2016 |
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, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares, issued | 24,933,944 | 22,802,778 |
Common stock, shares, outstanding | 24,933,944 | 22,802,778 |
Series A redeemable preferred stock | ||
Redeemable stock, par value ( in dollars per share) | $ 0.01 | |
Redeemable stock, shares authorized | 1,000,000 | |
Redeemable stock, shares issued | 32,628 | |
Redeemable stock, shares outstanding | 32,628 | |
Series B redeemable preferred stock | ||
Redeemable stock, par value ( in dollars per share) | $ 0.01 | |
Redeemable stock, shares authorized | 1,500,000 | |
Redeemable stock, shares issued | 0 | |
Redeemable stock, shares outstanding | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||
Collaboration revenues | $ 3,811,519 | $ 2,979,576 |
Operating expenses: | ||
Research and development | 23,809,749 | 32,763,178 |
General and administrative | 15,882,033 | 21,563,573 |
Operating expenses total | 39,691,782 | 54,326,751 |
Loss from operations | (35,880,263) | (51,347,175) |
Interest expense, net | 5,625,833 | 1,851,814 |
Change in fair value of warrant liability | (3,158,469) | |
Loss before income taxes | (38,347,627) | (53,198,989) |
Income tax expense | 501,500 | 103,000 |
Net loss | (38,849,127) | (53,301,989) |
Recognition of beneficial conversion feature upon issuance of Series A convertible preferred stock | (1,176,743) | |
Accretion of redeemable preferred stock and noncontrolling interests | (2,463,160) | |
Deemed dividend upon issuance of warrants to common stockholders | (7,373,820) | |
Net loss attributable to common stockholders | $ (40,025,870) | $ (63,138,969) |
Per share information: | ||
Net loss per share of common stock, basic (in dollars per share) | $ (1.67) | $ (3.67) |
Net loss per share of common stock, diluted (in dollars per share) | $ (1.80) | $ (3.67) |
Weighted average shares outstanding, basic (in shares) | 24,022,371 | 17,212,983 |
Weighted average shares outstanding, diluted (in shares) | 24,041,789 | 17,212,983 |
Consolidated Statements of Rede
Consolidated Statements of Redeemable Preferred Stock, Common Stock, Noncontrolling Interests and Stockholders' Equity (Deficit) - 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, 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) | |||||||||
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 | ||||||||
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 | |||||||||
Reclassification of stock-based compensation liability | 15,118,584 | 15,118,584 | ||||||||
Accretion of redeemable common stock | $ 2,463,160 | (2,463,160) | (2,463,160) | |||||||
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 | |||||||
Sale of common stock units upon consummation of initial public offering and concurrent private placement, net of issuance 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 | (53,301,989) | (53,301,989) | ||||||||
Balance at Sep. 30, 2016 | $ 228,028 | 141,965,342 | (147,366,275) | (5,172,905) | ||||||
Balance (in shares) at Sep. 30, 2016 | 22,802,778 | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Proceeds from exercise of common stock warrants | $ 7,869 | 305,616 | 313,485 | |||||||
Proceeds from exercise of common stock warrants (in shares) | 787,018 | |||||||||
Issuance of vested restricted stock units | $ 4,840 | (4,840) | ||||||||
Issuance of vested restricted stock units (in shares) | 483,913 | |||||||||
Issuance of common stock in connection with equity facility | $ 1,224 | (1,224) | ||||||||
Issuance of common stock in connection with equity facility (in shares) | 122,418 | |||||||||
Sale of common stock, net of issuance costs | $ 7,378 | 1,495,749 | 1,503,127 | |||||||
Sale of common stock, net of issuance costs (in shares) | 737,817 | |||||||||
Sale of Series A convertible preferred, net of costs | $ 2,924,441 | |||||||||
Sale of Series A convertible preferred, net of costs (in shares) | 32,628 | |||||||||
Series A convertible preferred stock dividends | (16,985) | (16,985) | ||||||||
Stock-based compensation expense | 8,571,430 | 8,571,430 | ||||||||
Net loss | (38,849,127) | (38,849,127) | ||||||||
Balance at Sep. 30, 2017 | $ 2,924,441 | $ 249,339 | $ 152,315,088 | $ (186,215,402) | $ (33,650,975) | |||||
Balance (in shares) at Sep. 30, 2017 | 32,628 | 24,933,944 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
OPERATING ACTIVITIES | ||
Net loss | $ (38,849,127) | $ (53,301,989) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,692,100 | 2,394,279 |
Non-cash interest expense | 4,014,633 | 13,465 |
Stock-based compensation | 8,571,430 | 12,450,079 |
Change in fair value of warrant liability | (3,158,469) | |
Loss on disposal of fixed assets | 61,867 | 13,647 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 20,000 | |
Prepaid expenses and other current assets | 2,607,520 | (1,533,498) |
Other assets | 112,439 | 57,423 |
Accounts payable | 5,727,136 | (5,326,374) |
Accrued expenses | 893,526 | 1,154,712 |
Income taxes payable | 497,500 | 100,000 |
Deferred revenue | 1,188,481 | (1,979,576) |
Other liabilities | 135,910 | 455,160 |
Net cash used in operating activities | (15,505,054) | (45,482,672) |
INVESTING ACTIVITIES | ||
Purchase of property and equipment | (292,086) | (1,098,180) |
Net cash used in investing activities | (292,086) | (1,098,180) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of offering costs | 1,607,396 | 16,137,913 |
Proceeds from sale of common stock units in connection with initial public offering and private placement | 37,074,996 | |
Payment of offering costs and common stock issuance costs | (4,637,647) | |
Payment of debt issuance costs | (40,000) | |
Proceeds from subscriptions receivable | 4,280,149 | |
Proceeds from issuance of Series A convertible preferred stock | 3,262,800 | |
Proceeds from exercise of common stock warrants | 253,289 | |
Proceeds from the sale of senior secured notes and detachable warrants | 15,000,000 | |
Payments of capital leases obligations | (991,028) | (884,620) |
Proceeds from debt | 200,416 | |
Repayment of debt | (2,677,771) | (1,059,034) |
Repayment of stockholder notes | (11,601,696) | |
Change in restricted cash | 216,086 | (2,423) |
Proceeds from related party receivable | 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 | 16,630,772 | 39,861,764 |
Net increase (decrease) in cash | 833,632 | (6,719,088) |
Cash at beginning of year | 2,351,887 | 9,070,975 |
Cash at end of year | 3,185,519 | 2,351,887 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,339,644 | 2,061,073 |
Cash paid for income taxes | 1,500 | 3,000 |
Supplemental schedule of noncash investing activities: | ||
Purchases of property and equipment in accounts payable and accrued expenses | 68,507 | 634,941 |
Supplemental schedule of noncash financing activities: | ||
Accretion of redeemable common stock | 2,463,160 | |
Issuance of common and Series A preferred stock to redeemable preferred stockholders and noncontrolling interests upon reincorporation | 11,894,638 | |
Reclassification of equity classified stock-based compensation | (15,118,584) | |
Issuance of capital lease obligations in connection with purchase of property and equipment | 62,230 | $ 100,383 |
Series A convertible preferred stock dividends | 16,985 | |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses | $ 630,717 |
Organization and Operations
Organization and Operations | 12 Months Ended |
Sep. 30, 2017 | |
Organization And Description Of Business [Abstract] | |
Organization and Operations | 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 ® ® |
Liquidity
Liquidity | 12 Months Ended |
Sep. 30, 2017 | |
Liquidity [Abstract] | |
Liquidity | 2. Liquidity The Company has incurred substantial losses and negative cash flows from operations since its inception and has an accumulated deficit of $186.2 million as of September 30, 2017. The Company has substantial indebtedness that includes $13.5 million of senior secured notes due in December 2018 and $4.6 million in notes payable to stockholders that are payable on demand. There can be no assurance that the holders of the stockholder notes will not exercise their right to demand repayment. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying 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. In September 2017, the Company entered into a purchase agreement (the “Purchase Agreement”) with GMS Tenshi Holdings Pte. Limited, a Singapore private limited company (“GMS Tenshi”), pursuant to which GMS Tenshi agreed to purchase, in a private placement (the “Private Placement”), $25.0 million of the Company’s newly-created voting Series A Convertible Preferred Stock (the “Series A Convertible”), and warrants (the “GMS Tenshi Warrants” and together with the Series A Convertible, the “Securities”) to acquire 16,750,000 shares of common stock. On September 11, 2017, the Company completed the initial sale of 32,628 shares of Series A Convertible to GMS Tenshi for $3,262,800 in cash. In October 2017, the Company completed the sale of the remaining 217,372 shares of Series A Convertible and the GMS Tenshi Warrants to GMS Tenshi in the Private Placement, for $21,737,200 in cash (see Note 16). Also in September 2017, the Company entered into a purchase and exchange agreement (the “Exchange Agreement”) with two existing investors and holders of its senior secured notes (the “Noteholders”), pursuant to which the Noteholders agreed to exchange $1.5 million aggregate principal amount of Notes (see Note 8) for the Company’s newly-created non-voting Series B Convertible Preferred Stock (the “Series B Convertible”) and forgive any unpaid interest on such exchanged Notes. This exchange occurred in connection with the completion of the Private Placement in October 2017. Management believes that the Company’s existing cash as of September 30, 2017 and the net proceeds from the completion of the Private Placement will be sufficient to fund its operations through June 2018. Substantial additional financing will be needed by the Company to fund its operations in the future 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, providing manufacturing services on a contract basis to other biopharmaceutical 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, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying 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”). 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. Restricted cash As of September 30, 2016, the Company had $216,086 in certificates of deposit related to the requirements of the Company’s bank loans. In December 2016, the Company repaid the senior bank loans therefore releasing this requirement. Fair value of financial instruments At September 30, 2017 and 2016, the Company’s financial instruments included accounts payable, accrued expenses, stockholder notes and senior secured debt. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments. As of September 30, 2017, the carrying value of the warrant liability was the estimated fair value of the liability (See Note 4). Prepaid expenses and other current assets As of September 30, 2017 and 2016, the Company had prepaid research and development of $199,740 and $1,979,527, 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 for the years ended September 30, 2017 and 2016. 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 12. 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. 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. Net loss per share Basic net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock awards using the treasury stock method. The diluted net loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. The following table sets forth the computation of basic earnings per share and diluted earnings per share as of September 30, 2017 and 2016: Year ended September 30, 2017 2016 Basic Earnings Per Share Net loss $ (40,025,870 ) $ (63,138,969 ) Common stock outstanding (weighted average) 24,022,371 17,212,983 Basic net loss per share $ (1.67 ) $ (3.67 ) Diluted Earnings Per Share Net loss $ (40,025,870 ) $ (63,138,969 ) Add change in fair value of warrant liability (3,158,469 ) — Diluted net loss (43,184,339 ) (63,138,969 ) Common stock outstanding (weighted average) 24,022,371 17,212,983 Add shares from dilutive warrants 19,418 — Common stock equivalents 24,041,789 17,212,983 Diluted net loss per share $ (1.80 ) $ (3.67 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2017 and 2016, as they would be antidilutive: September 30, 2017 2016 Performance-based stock units 175,530 247,309 Restricted stock units 939,879 1,094,269 Common stock warrants 7,484,504 8,186,934 Correction of Immaterial Error Related to Prior Periods During the year ended September 30, 2017, the Company identified an error related to its accounting and classification for the 82,000 square feet of office and laboratory space in Cranbury, New Jersey that was entered into during August 2015. Due to the Company’s involvement in the construction required to complete the leased facility, the Company concluded that the lease should have been accounted for as a direct financing arrangement, whereby the Company records, the fair value of the asset in property and equipment, net on the consolidated balance sheets. A corresponding liability is also recorded and amortized over the lease term through monthly rental payments using the effective interest method. As a result of the error, property and equipment and other long-term liabilities were each understated by $1.7 million in the Company’s consolidated balance sheet as of September 30, 2015. As of September 30, 2016, property and equipment and other liabilities were each understated by $1.7 million. For the year ended September 30, 2016, rent expense was overstated by $0.4 million and interest expense was understated by $0.4 million. This was primarily attributable to the reclassification of rental payments into interest expense payments in connection with a financing arrangement rather than an operating lease arrangement, as previously presented. The Company reviewed the impact of this error on the prior periods in accordance with Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin No. 99, “Materiality,” and determined that the error was not material to the prior periods. However, the Company has corrected the consolidated balance sheet, as of September 30, 2016, by increasing property and equipment and other long-term liabilities each by $1.7 million. The Company has corrected the consolidated statement of operations for the year ended September 30, 2016 by decreasing research and development expenses and general and administrative expenses by $0.3 million and $0.1 million, respectively, and by increasing interest expense by $0.4 million. Recently issued and adopted accounting pronouncements In May 2014, the FASB issued ASU, No. 2014-09, Revenue from Contracts with Customers Contracts with customers Significant judgments and changes in judgments Certain assets — 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 August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU No. 2016-02, Leases In May 2017, the FASB issued ASU No. 2017-09, Compensation — Stock Compensation |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 — Quoted prices in active markets for identical assets or liabilities. • Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis: September 30, 2017 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 2,274,954 The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability for the year ended September 30, 2017: Balance at October 1, 2016 $ — Issuance of warrants 5,493,619 Exercise of warrants (60,196 ) Change in fair value (3,158,469 ) Balance at September 30, 2017 $ 2,274,954 The Senior Note Warrants issued in connection with the Notes (see Note 8) are classified as liabilities on the accompanying consolidated balance sheet as the Senior Note Warrants include cash settlement features at the option of the holders under certain circumstances. The warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair value of the warrant liability is estimated using the Black- Scholes option pricing model using the following assumptions: September 30, 2017 Risk-free interest rate 1.77% Remaining contractual life of warrant 4.67 years Expected volatility 82% Annual dividend yield 0% Fair value of common stock $1.37 per share |
Property and Equipment
Property and Equipment | 12 Months Ended |
Sep. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment, net, consists of: September 30, 2017 2016 Laboratory equipment $ 11,574,473 $ 11,452,858 Leasehold improvements 10,032,640 10,031,739 Computer software and hardware 472,054 421,206 Construction in progress 2,654,675 2,714,690 24,733,843 24,620,493 Less: accumulated depreciation and amortization (8,644,941 ) (5,961,940 ) $ 16,088,902 $ 18,658,553 Depreciation and amortization expense for the years ended September 30, 2017 and 2016 was $2,692,100 and $2,394,279, respectively. At September 30, 2017 and 2016, $3,692,913 and $3,630,683, respectively represents laboratory equipment under capital leases. The term of the leases are between 22 and 36 months and qualify as capital leases. The leases bear interest between 5.0 % and 19.4 %. At September 30, 2017 and 2016, $1,061,901 and $732,002, 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, 2017 for the years ending September 30: 2018 $ 367,782 2019 23,896 2020 5,974 397,652 Less: amounts representing interest (28,465 ) Less: current portion (341,120 ) Capital lease obligations, excluding current portion $ 28,067 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Sep. 30, 2017 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consists of: September 30, 2017 2016 Compensation $ 3,688,592 $ 3,884,386 Research and development . 1,637,657 1,343,910 Interest payable 1,047,122 234,754 Deferred offering costs — 26,028 Professional fees 521,973 486,705 Director fees 376,695 73,125 Other accrued expenses 65,430 73,034 $ 7,337,469 $ 6,121,942 |
Stockholder Notes
Stockholder Notes | 12 Months Ended |
Sep. 30, 2017 | |
Short-term Debt [Abstract] | |
Stockholder Notes | 7. Stockholder Notes September 30, 2017 2016 Restricted stock purchase notes $ 800,000 $ 800,000 Common stock repurchase note 2,812,500 2,812,500 Working capital notes 1,000,000 1,000,000 4,612,500 4,612,500 Less: current portion (4,612,500 ) (4,612,500 ) $ — $ — The Company previously repurchased shares of its restricted stock in exchange for $1,097,750 in notes which bear interest at rates ranging from 0% to 4% per annum 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. 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, 2017 and 2016, the Company recognized interest expense related to the stockholder notes of $320,000 and $589,675, respectively. |
Debt
Debt | 12 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Debt | 8. Debt Senior Secured Notes September 30, Senior secured notes $ 15,000,000 Unamortized debt discount (1,768,300 ) $ 13,231,700 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. The unsecured notes were exchanged for senior secured promissory notes in December 2016 as described below. In December 2016, the Company entered into a Note and Warrant Purchase Agreement (the “NWPA”) with accredited investors providing for the issuance and sale of up to $10.0 million of senior secured promissory notes (the “Notes”), which bear interest at a rate of 5% per year and mature December 22, 2017 and warrants (the “Senior Note 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 Senior Note Warrants in December 2016, issuing $8.35 million aggregate principal amount of Notes and Senior Note Warrants to acquire up to 1,920,500 shares of the Company’s common stock in exchange for $6.5 million of cash and an aggregate of $1.85 million of existing unsecured bridge notes issued by the Company in October, November and December 2016. The proceeds were first allocated to the warrant liability based on an initial fair value of $3.3 million with a corresponding amount recorded as a debt discount. In addition, the Company incurred $40,000 of debt issuance costs that have been recorded as a debt discount. The debt discount is being amortized into interest expense over the term of the Notes. The Company used $2.4 million of the proceeds from the sale of the Notes to pay off its remaining senior secured bank loans, and will use the remainder for working capital purposes. In January 2017, the Company issued additional Notes and Senior Note Warrants for $1.65 million of cash. In April 2017, the Company entered into the First Amendment to the NWPA (the “Amendment”) with the required holders of its Notes named therein, to amend certain terms of the NWPA. The primary purpose of the Amendment was to increase the aggregate principal amount of Notes that may be sold under the NWPA from $10.0 million to $15.0 million, and permit the issuance of additional Senior Note Warrants to acquire an aggregate 1,665,000 shares of the Company’s common stock and extend the time that the Company may issue additional Notes and Senior Note Warrants without approval of the holders of existing notes from 90 days to 180 days. Notes sold under the Amendment bear interest at a rate of 5% per annum and mature in December 2017. In September 2017, in connection with the Private Placement, the maturity date of the Notes was extended by one year to December 2018. During April and May 2017, the Company issued an additional $5.0 million of Notes and Senior Note Warrants to acquire an aggregate of 1,304,500 shares of its common stock. The proceeds were first allocated to the warrant liability based on an initial fair value of $1.4 million with a corresponding amount recorded as a debt discount. In addition, the Company incurred $3,635 of debt issuance costs that have been recorded as a debt discount. The debt discount is being amortized into interest expense over the term of the Notes. Under the NWPA and the Amendment, the Company agreed to customary negative covenants restricting its ability to repay indebtedness to officers, pay dividends to stockholders, repay or incur other indebtedness other than as permitted, grant or suffer to exist a security interest in any of the Company’s assets, other than as permitted, or enter into any transactions with affiliates. In addition to the negative covenants in the NWPA, the Notes include customary events of default. In connection with the closing of the initial sale of the Notes and Senior Note Warrants, the Company entered into a Security Agreement and an Intellectual Property Security Agreement, each dated December 22, 2016, granting the holders of the Notes a security interest in all of its assets, as well as a Registration Rights Agreement dated February 3, 2017. In September 2017, the Company entered into the Exchange Agreement with the Noteholders, pursuant to which the Noteholders agreed to exchange $1.5 million aggregate principal amount of Notes for Series B Convertible and forgive any unpaid interest on such exchanged Notes. This exchange occurred in connection with the completion of the Private Placement in October 2017. Interest expense on the Notes for the year ended September 30, 2017 was $4,441,886. Other Indebtedness In addition to the Notes, the Company has several other types of outstanding debt consisting of term bank loans and equipment loans. September 30, 2017 2016 Term loans – Bank $ — $ 2,526,502 Equipment loans 203,710 354,979 Unamortized financing costs — (61,224 ) 203,710 2,820,257 Less: current portion (52,600 ) (586,454 ) Long-term debt $ 151,110 $ 2,233,803 The term bank loans bore interest at the prime rate plus 2.75% and were adjusted monthly. In December 2016, the remaining balance of the term loans were paid in full releasing the prior requirements of a certificate of deposit. 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, 2017 and 2016 was $230,824 and $287,280, respectively. Future maturities of other indebtedness at September 30, 2017 are as follows for the years ending September 30: 2018 $ 52,600 2019 151,110 $ 203,710 |
Commitments
Commitments | 12 Months Ended |
Sep. 30, 2017 | |
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 Laboratories Liomont, S.A. de C.V. (“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 $353,600 (based on an exchange rate on September 30, 2017 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. Rent expense under operating leases was $1,352,708 and $1,207,882 for the years ended September 30, 2017 and 2016, 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. 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 expires in March 2026. The lease is accounted for as a financing arrangement to which a liability is recorded and amortized over the lease term down to the expected asset value at the end of the lease. During the years ended September 30, 2017 and 2016, the Company recorded interest expense of $421,028 and $383,864, respectively. Future minimum payments under noncancelable operating leases and the financing arrangement at September 30, 2017 are as follows for the years ending September 30: Operating Financing 2018 $ 1,299,664 $ 418,200 2019 1,333,427 418,200 2020 1,353,345 418,200 2021 1,180,967 454,936 2022 372,964 481,176 Thereafter 1,096,012 1,644,018 $ 6,636,379 $ 3,834,730 Employee 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, 2017 and 2016, the expense relating to the matching contribution was $209,782 and $191,097, respectively. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Sep. 30, 2017 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity (Deficit) | 10. Stockholders’ Equity (Deficit) Lincoln Park Capital, LLC transaction In March 2017, the Company entered into a Purchase Agreement and a registration rights agreement with an accredited investor, Lincoln Park Capital, LLC (“Lincoln Park”), providing for the purchase of up to $15.4 million of the Company’s common stock over the 30-month term of the purchase agreement. In connection with the purchase agreement, the Company issued 113,205 shares of its common stock as initial commitment shares, to Lincoln Park and the Company will issue, pro rata, up to an additional 113,206 shares of its common stock as additional commitment shares to Lincoln Park in connection with any additional purchases. Under the terms and subject to the conditions of the purchase agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to an additional $15.0 million worth of shares of the Company’s common stock. As contemplated by the purchase agreement, and so long as the closing price of the Company’s common stock exceeds $1.50 per share, the Company may direct Lincoln Park, at the Company’s sole discretion to purchase up to 30,000 shares of its common stock on any business day. The price per share for such purchases will be equal to the lower of: (i) the lowest sale price on the applicable purchase date and (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive business days ending on the business day immediately preceding such purchase date (in each case, to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction that occurs on or after the date of the purchase agreement). The maximum amount of shares subject to any single regular purchase increases as the Company’s share price increases, subject to a maximum of $1.0 million. In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the purchase agreement. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 4.99% of its common stock. There are neither trading volume requirements nor restrictions under the purchase agreement nor upper limits on the price per share that Lincoln Park must pay for shares of common stock. The purchase agreement and the registration rights agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the purchase agreement at any time, at no cost or penalty. During any “event of default” under the purchase agreement, all of which are outside of Lincoln Park’s control, Lincoln Park does not have the right to terminate the purchase agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such event of default is cured. In addition, in the event of bankruptcy proceedings by or against the Company, the purchase agreement will automatically terminate. During the year ended September 30, 2017, the Company sold 737,817 shares of common stock to Lincoln Park for $1,620,931, and incurred $147,540 of issuance costs. In addition, the Company issued 122,418 shares of common stock to Lincoln Park as commitment shares pursuant to the purchase agreement. Common stock 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 initial public offering (“IPO”) and concurrent 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, raising $33,784,205 in aggregate net proceeds. Each unit consisted of one share of the Company’s common stock and ½ a Series A warrants and ½ a Series B warrant. 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, 2017. Common stock warrants As of September 30, 2017, the Company had the following warrants outstanding to acquire shares of its common stock: Outstanding Exercise Expiration date Series A warrants 3,333,333 $ 6.60 February 18, 2018 Series B warrants 3,333,333 $ 8.50 May 18, 2018 Common stock warrants issued with IPO 817,838 $ 0.01 November 11, 2019 Common stock warrants issued with senior secured notes 3,521,501 $ 3.00 December 22, 2021 11,006,005 During the year ended September 30, 2017, warrants to purchase 704,019 and 82,999 shares with exercise prices of $0.01 and $3.00 per share respectively, were exercised. |
Convertible Preferred Stock
Convertible Preferred Stock | 12 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Convertible Preferred Stock | 11. Convertible Preferred Stock As discussed in Note 1, the Company entered into the Purchase Agreement with GMS Tenshi in September 2017 pursuant to which GMS Tenshi agreed to purchase an aggregate 250,000 shares of Series A Convertible at a purchase price of $100.00 per share, for an aggregate purchase price of $25.0 million in cash. The Series A Convertible is initially convertible into 37,795,948 shares of the Company’s common stock, representing an effective conversion rate of $0.66 per share, which represents a discount to the market value of the Company’s common stock as of September 7, 2017 (on which date, the closing price of the Company’s common stock was $0.90 per share). In addition to the sale of the Series A Preferred, the Company also agreed to issue GMS Tenshi the GMS Tenshi Warrants, which have a term of 8-years and an initial exercise price of $0.90 per share. In September 2017, the Company closed the initial sale of 32,628 shares of Series A Convertible for an aggregate purchase price of $3,262,800. In connection with the initial sale, the Company recognized a beneficial conversion charge of $1,176,743 which represents the in-the-money value of the conversion rate as of the date of sale. GMS Tenshi purchased the remaining 217,372 shares of Series A Convertible and the GMS Tenshi Warrants in October 2017, for a purchase price of $21,737,200. In connection with the entry into the Purchase Agreement, the Company filed a Certificate of Designation of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock of Oncobiologics, Inc. (the “Certificate of Designation”) with the Secretary of State of the State of Delaware. Series A Convertible Preferred Stock The Series A Convertible accrue dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A Convertible, although the initial dividends payable on the shares of Series A Convertible issued in September 2017, while accruing from issuance, will be payable in December 2017. The Series A Convertible will also be entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of common stock or other securities. The initial conversion rate is subject to appropriate adjustment in the event of a stock split, stock dividend, combination, reclassification or other recapitalization affecting the common stock. The holders of the Series A Convertible will have the right to vote on matters submitted to a vote of the Company’s stockholders on an as-converted basis. In addition, without the prior written consent of a majority of the outstanding shares of Series A Convertible, the Company may not take certain actions. The terms of the Series A Convertible distinguish between certain liquidation events (such as a voluntary or involuntary liquidation, dissolution or winding up of the Company) and “deemed” liquidation events (such as a sale of all or substantially all of the Company’s assets, various merger and reorganization transactions, being delisted from NASDAQ, and the occurrence of an event of default under the terms of the Notes), in each case as defined in the Certificate of Designation. In the event of a liquidation (as defined in the Certificate of Designation) the liquidation preference payable equals the sum of (A) 110% of the stated value per share plus (B) (x) 110% of any accrued but unpaid preferred dividends (as defined in the Certificate of Designation) plus (y) any unpaid participating dividends (as defined in the Certificate of Designation). In the case of a deemed liquidation event (as defined in the Certificate of Designation), the multiplier is increased to 120%. The Series A Convertible is convertible at any time at the option of the holder based on the then applicable conversion rate. If conversion is in connection with a liquidation, the holder is entitled to receive 110% of the number of shares of common stock issuable based upon the then applicable conversion rate. In the event of a deemed liquidation event (as defined in the Certificate of Designation), the multiplier is increased to 120%. Additionally, the holder may require the Company to redeem the Series A Convertible in the event of deemed liquidation event for the sum of (A) 120% of the stated value per share plus (B) (x) 120% of any accrued but unpaid preferred dividends (as defined in the Certificate of Designation) plus (y) any unpaid participating dividends (as defined in the Certificate of Designation), although such redemption may not be made without the consent of the senior secured noteholders if such notes are outstanding at the time of any such redemption. Series B Convertible Preferred Stock In September 2017, the Company entered the Exchange Agreement with the Noteholders whereby, upon consummation of the sale of the remaining 217,372 shares of Series A Convertible to GMS Tenshi in the Private Placement, the Noteholders would exchange $1,500,000 in aggregate principal amount of Notes for 1,500,000 shares of Series B Convertible. The exchange occurred in October 2017. The Series B Convertible are non-voting, do not accrue dividends nor do the shares of Series B Convertible have any specific rights or preferences, and have a stated value of $1.00 per share and are convertible into 2,112,676 shares of common stock. The Series B Convertible are not convertible into common stock if the holder thereof would beneficially own more than 9.99% of the common stock, or, if during the first six-month period following the closing of the exchange, 7.50%, but automatically converts into common stock in part from time to time if the holder beneficially owns below a certain beneficial ownership threshold of the common stock. Former Series A Preferred Stock In connection with the May 2016 closing of the Company’s IPO, all outstanding shares of the former Series A Preferred converted into 1,969,818 shares of common stock. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 12. 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, 2017, performance-based stock unit awards (“PSUs”) representing 175,528 shares of the Company’s common stock were outstanding under the 2011 Plan. In light of the December 2015 adoption of the 2015 Equity Incentive Plan, no future awards under the 2011 Plan will be granted. 2015 Equity Incentive Plan In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The maximum number of shares of common stock that may be issued under the 2015 Plan is 2,638,101 shares. As of September 30, 2017, RSUs representing 939,879 shares of the Company’s common stock were outstanding under the 2015 Plan and 1,214,309 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, 2017 and 2016: Year ended September 30, 2017 2016 Research and development $ 1,001,022 $ 2,044,379 General and administrative 7,570,408 10,405,700 $ 8,571,430 $ 12,450,079 Year ended September 30, 2017 2016 Equity-classified compensation $ 8,571,430 $ 10,058,217 Liability-classified compensation — 2,391,862 $ 8,571,430 $ 12,450,079 Performance-Based Stock Units The Company has issued PSUs, which generally have a ten year life from the date of grant and vest 50% after the third anniversary from issuance and the remaining 50% on the fourth anniversary. The PSUs are exercisable upon the earlier of (i) a change in control, (ii) consummation of an initial public offering, or (iii) a corporate valuation in excess of $400 million. Upon exercise, the PSU holder receives common stock or cash at the Company’s discretion. The following table summarizes the activity related to PSUs during the years ended September 30, 2017 and 2016: Number of Weighted-Average 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 October 1, 2016 247,309 6.33 Forfeitures (71,779 ) 6.46 Balance at September 30, 2017 175,530 $ 6.27 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, 2017, there was $89,428 of unamortized expense that will be recognized over a weighted-average period of 1.1 years. Restricted Stock Units The following table summarizes the activity related to RSUs during the years ended September 30, 2017 and 2016: 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 October 1, 2016 1,094,351 28.61 Granted 615,000 2.11 Vested and settled (483,913 ) 29.05 Forfeitures (285,559 ) 3.14 Balance at September 30, 2017 939,879 $ 18.78 The Company has granted RSUs that generally vest over a period of two to four years from the date of grant. In addition, vesting of certain of the RSUs was also dependent upon the closing of the IPO, which is a performance condition that is outside the Company’s control. Therefore, the Company did not recognize any stock-based compensation until the consummation of the IPO in May 2016. As of September 30, 2017, there was $4,265,887 of unamortized expense that will be recognized over a weighted-average period of 0.9 years. |
Collaboration Arrangements
Collaboration Arrangements | 12 Months Ended |
Sep. 30, 2017 | |
Collaboration Arrangements [Abstract] | |
Collaboration Arrangements | 13. 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 2021, the expected date in which the research and development will be completed. Substantive milestones received under the Huahai arrangement are recognized upon achievement. During the years ended September 30, 2017 and 2016, the Company recognized $714,848 and $1,175,580 of deferred revenues, respectively. As of September 30, 2017 and 2016, deferred revenue included in the Company’s consolidated balance sheet related to the Huahai arrangement was $3,038,102 and $3,752,950, 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, 2017 and 2016, the Company recognized deferred revenues of $261,072 and $421,732, respectively. As of September 30, 2017 and 2016, deferred revenue included in the Company’s consolidated balance sheets was $1,109,558 and $1,370,630, respectively. Liomont Agreement In June 2014, the Company entered into a strategic license agreement with 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, 2017 and 2016, the Company recognized deferred revenue of $236,641 and $382,264, respectively. As of September 30, 2017 and 2016, deferred revenue included in the Company’s consolidated balance sheets was $1,005,724 and $1,242,365. GMS Tenshi Agreement In July 2017, the Company entered into a strategic licensing agreement with GMS Tenshi, under which it granted GMS Tenshi and its affiliates a perpetual, irrevocable, exclusive, sublicensable license in the agreed territory for the research, development, manufacture, use or sale of the ONS-1045 biosimilar product candidate in the agreed territory. The agreed territory includes all emerging markets but specifically excludes major developed markets, such as the United States, Canada, Europe, Japan, Australia and New Zealand, and smaller markets where the Company has existing licensing arrangements, such as Mexico, greater China and India. The Company received an initial upfront payment from GMS Tenshi of $1.25 million, and an additional $1.25 million upon meeting a notice and acknowledgment milestone. In September 2017 the Company and GMS Tenshi superseded and replaced the strategic license agreement with a Joint Development and License Agreement (the “JDLA”) providing for the development and commercialization of the Company’s ONS-3010 and ONS-1045 biosimilar product candidates in the same geographic territories. In exchange for granting GMS Tenshi a perpetual, irrevocable, exclusive, sublicensable license in the agreed territory for the research, development, manufacture, use or sale of the ONS-3010 and ONS-1045 biosimilar product candidates in the agreed territory, GMS Tenshi made an additional payment of $2.5 million in connection with the JDLA. The Company may receive up to an additional $2.5 million milestone payments under the JDLA for each licensed product upon achievement of certain net profit thresholds. The parties agreed to share net profits based on sales of licensed products in the agreed territory, in proportions weighed in GMS Tenshi’s favor, subject to adjustment as provided in the agreement. During the year ended September 30, 2017, the Company recognized revenue of $2,598,958 under the GMS Tenshi agreements. As of September 30, 2017, deferred revenue included in the Company’s consolidated balance sheet was $2,401,042. |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Sep. 30, 2017 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 14. Related-Party Transactions During the years ended September 30, 2017 and 2016, there were no related party transactions other than as previously disclosed for the Stockholder Notes (Note 7), Debt (Note 8) and the GMS Tenshi Agreement (Note 13). |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income Taxes Income tax expense for the years ended September 30, 2017 and 2016 consists of the following: Year Ended September 30, 2017 2016 State tax $ 1,500 $ 3,000 Foreign tax provision 500,000 100,000 $ 501,500 $ 103,000 The Company incurred $0.5 million and $0.1 million of foreign withholding taxes in connection with the Company’s collaboration and licensing agreements during the years ended September 30, 2017 and 2016, 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, 2017 2016 U.S. federal statutory rate (34.0 )% (34.0 )% State taxes, net of federal benefit (6.4 ) (5.9 ) Foreign witholding tax 1.3 0.2 Permanent differences (2.8 ) — Foreign tax credits (1.6 ) — Change in valuation allowance 44.8 40.0 Other — (0.1 ) Effective income tax rate 1.3 % 0.2 % The tax effects of the temporary differences that gave rise to deferred taxes were as follows: September 30, 2017 2016 Deferred tax assets Net operating loss carryforwards $ 48,828,141 $ 36,146,789 Stock compensation 14,098,985 11,249,314 Deferred revenue 3,017,238 2,542,558 Research and development credit carryforward 757,701 757,701 Foreign tax credits 2,857,309 2,257,309 Accruals and others 1,539,943 1,287,592 Gross deferred tax assets 71,099,317 54,241,263 Less: valuation allowance (69,902,446 ) (52,737,104 ) 1,196,871 1,504,159 Deferred tax liability: Fixed assets (1,196,871 ) (1,504,159 ) Net deferred tax assets $ — $ — As of September 30, 2017, the Company has approximately $131.5 million and $69.6 million of Federal and New Jersey net operating losses (“NOLs”) that will begin to expire in 2030 and 2036, respectively. As of September 30, 2017, the Company has federal and state research and development (“R&D”) tax credit carryforwards of $0.8 million available to reduce future tax liabilities, which will begin to expire in 2031. As of September 30, 2017, the Company has Federal foreign tax credit carryforwards of $2.9 million available to reduce future tax liabilities which will begin to expire starting in 2023. $2.4 million of the Federal foreign tax credit 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, 2017 and 2016. The valuation allowance increased $17.1 million and $14.1 million during the years ended September 30, 2017 and 2016, 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, 2017 2016 Balance at beginning of year $ 1,854,629 $ 1,754,629 Additions based on tax positions related to the current year 497,500 100,000 Balance at end of year $ 2,352,129 $ 1,854,629 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 2016 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 NOL 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 NOL 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, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events On October 31, 2017, following receipt of the requisite stockholder approval under applicable NASDAQ listing rules and pursuant to the Purchase Agreement, the Company issued the remaining 217,372 shares of Series A Convertible and the GMS Tenshi Warrants to GMS Tenshi for an aggregate purchase price of $21,737,200. The GMS Tenshi Warrants are exercisable into 16,750,000 shares of common stock at $0.90 per share and have a term of eight years. Concurrent therewith, and pursuant to the Exchange Agreement, the Noteholders exchanged $1,500,000 in aggregate principal of Notes for 1,500,000 shares of the Series B Convertible and forgave any accrued but unpaid interest thereon. In November 2017, the Company received approval from the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer Program to sell a portion of its unused New Jersey NOLs and R&D tax credits. As a result, the Company received $3.15 million of cash from the sale of these NOLs and credits in December 2017. |
Basis of Presentation and Sum23
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2017 | |
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”). |
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. |
Restricted cash | Restricted cash As of September 30, 2016, the Company had $216,086 in certificates of deposit related to the requirements of the Company’s bank loans. In December 2016, the Company repaid the senior bank loans therefore releasing this requirement. |
Fair value of financial instruments | Fair value of financial instruments At September 30, 2017 and 2016, the Company’s financial instruments included accounts payable, accrued expenses, stockholder notes and senior secured debt. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments. As of September 30, 2017, the carrying value of the warrant liability was the estimated fair value of the liability (See Note 4). |
Prepaid expenses and other current assets | Prepaid expenses and other current assets As of September 30, 2017 and 2016, the Company had prepaid research and development of $199,740 and $1,979,527, 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 for the years ended September 30, 2017 and 2016. |
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 12. 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. |
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. |
Net loss per share | Net loss per share Basic net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock awards using the treasury stock method. The diluted net loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. The following table sets forth the computation of basic earnings per share and diluted earnings per share as of September 30, 2017 and 2016: Year ended September 30, 2017 2016 Basic Earnings Per Share Net loss $ (40,025,870 ) $ (63,138,969 ) Common stock outstanding (weighted average) 24,022,371 17,212,983 Basic net loss per share $ (1.67 ) $ (3.67 ) Diluted Earnings Per Share Net loss $ (40,025,870 ) $ (63,138,969 ) Add change in fair value of warrant liability (3,158,469 ) — Diluted net loss (43,184,339 ) (63,138,969 ) Common stock outstanding (weighted average) 24,022,371 17,212,983 Add shares from dilutive warrants 19,418 — Common stock equivalents 24,041,789 17,212,983 Diluted net loss per share $ (1.80 ) $ (3.67 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2017 and 2016, as they would be antidilutive: September 30, 2017 2016 Performance-based stock units 175,530 247,309 Restricted stock units 939,879 1,094,269 Common stock warrants 7,484,504 8,186,934 |
Correction of Immaterial Error Related to Prior Periods | Correction of Immaterial Error Related to Prior Periods During the year ended September 30, 2017, the Company identified an error related to its accounting and classification for the 82,000 square feet of office and laboratory space in Cranbury, New Jersey that was entered into during August 2015. Due to the Company’s involvement in the construction required to complete the leased facility, the Company concluded that the lease should have been accounted for as a direct financing arrangement, whereby the Company records, the fair value of the asset in property and equipment, net on the consolidated balance sheets. A corresponding liability is also recorded and amortized over the lease term through monthly rental payments using the effective interest method. As a result of the error, property and equipment and other long-term liabilities were each understated by $1.7 million in the Company’s consolidated balance sheet as of September 30, 2015. As of September 30, 2016, property and equipment and other liabilities were each understated by $1.7 million. For the year ended September 30, 2016, rent expense was overstated by $0.4 million and interest expense was understated by $0.4 million. This was primarily attributable to the reclassification of rental payments into interest expense payments in connection with a financing arrangement rather than an operating lease arrangement, as previously presented. The Company reviewed the impact of this error on the prior periods in accordance with Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin No. 99, “Materiality,” and determined that the error was not material to the prior periods. However, the Company has corrected the consolidated balance sheet, as of September 30, 2016, by increasing property and equipment and other long-term liabilities each by $1.7 million. The Company has corrected the consolidated statement of operations for the year ended September 30, 2016 by decreasing research and development expenses and general and administrative expenses by $0.3 million and $0.1 million, respectively, and by increasing interest expense by $0.4 million. |
Recently issued and adopted accounting pronouncements | Recently issued and adopted accounting pronouncements In May 2014, the FASB issued ASU, No. 2014-09, Revenue from Contracts with Customers Contracts with customers Significant judgments and changes in judgments Certain assets — 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 August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU No. 2016-02, Leases, (Topic 842). This new ASU represents a wholesale change to lease accounting and introduces a lease model that brings most leases on the balance sheet. It also eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. This ASU is effective for annual periods beginning after December 15, 2018 (i.e., calendar periods beginning on January 1, 2019), and interim periods thereafter. Earlier application is permitted for all entities. The Company is currently evaluating the impact of ASU 2016-02 on its consolidated financial statements. In May 2017, the FASB issued ASU No. 2017-09, Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting. This new ASU is intended provide clarity and reduce both the diversity in practice of and cost and complexity of applying the guidance in Topic 718, Compensation — Stock Compensation, to a change to the terms or conditions of a share-based payment award. This ASU provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This ASU is effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted. This ASU is not expected to have a material impact on the Company’s consolidated financial statements. |
Basis of Presentation and Sum24
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Schedule of dilutive securities excluded from the computation weighted-average shares | Year ended September 30, 2017 2016 Basic Earnings Per Share Net loss $ (40,025,870 ) $ (63,138,969 ) Common stock outstanding (weighted average) 24,022,371 17,212,983 Basic net loss per share $ (1.67 ) $ (3.67 ) Diluted Earnings Per Share Net loss $ (40,025,870 ) $ (63,138,969 ) Add change in fair value of warrant liability (3,158,469 ) — Diluted net loss (43,184,339 ) (63,138,969 ) Common stock outstanding (weighted average) 24,022,371 17,212,983 Add shares from dilutive warrants 19,418 — Common stock equivalents 24,041,789 17,212,983 Diluted net loss per share $ (1.80 ) $ (3.67 ) |
Schedule of dilutive securities excluded from the computation weighted-average shares | September 30, 2017 2016 Performance-based stock units 175,530 247,309 Restricted stock units 939,879 1,094,269 Common stock warrants 7,484,504 8,186,934 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | September 30, 2017 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 2,274,954 |
Summary of changes in the fair value of the Company's Level 3 valuation for the warrant liability | Balance at October 1, 2016 $ — Issuance of warrants 5,493,619 Exercise of warrants (60,196 ) Change in fair value (3,158,469 ) Balance at September 30, 2017 $ 2,274,954 |
Schedule of fair value of the performance-based stock units (PSUs) | September 30, 2017 Risk-free interest rate 1.77% Remaining contractual life of warrant 4.67 years Expected volatility 82% Annual dividend yield 0% Fair value of common stock $1.37 per share |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | September 30, 2017 2016 Laboratory equipment $ 11,574,473 $ 11,452,858 Leasehold improvements 10,032,640 10,031,739 Computer software and hardware 472,054 421,206 Construction in progress 2,654,675 2,714,690 24,733,843 24,620,493 Less: accumulated depreciation and amortization (8,644,941 ) (5,961,940 ) $ 16,088,902 $ 18,658,553 |
Schedule of future minimum lease payments under capital leases | 2018 $ 367,782 2019 23,896 2020 5,974 397,652 Less: amounts representing interest (28,465 ) Less: current portion (341,120 ) Capital lease obligations, excluding current portion $ 28,067 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Accrued Expenses [Abstract] | |
Schedule of accrued expenses | September 30, 2017 2016 Compensation $ 3,688,592 $ 3,884,386 Research and development . 1,637,657 1,343,910 Interest payable 1,047,122 234,754 Deferred offering costs — 26,028 Professional fees 521,973 486,705 Director fees 376,695 73,125 Other accrued expenses 65,430 73,034 $ 7,337,469 $ 6,121,942 |
Stockholder Notes (Tables)
Stockholder Notes (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Short-term Debt [Abstract] | |
Schedule of stockholder notes | September 30, 2017 2016 Restricted stock purchase notes $ 800,000 $ 800,000 Common stock repurchase note 2,812,500 2,812,500 Working capital notes 1,000,000 1,000,000 4,612,500 4,612,500 Less: current portion (4,612,500 ) (4,612,500 ) $ — $ — |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Senior Secured Notes debt | September 30, Senior secured notes $ 15,000,000 Unamortized debt discount (1,768,300 ) $ 13,231,700 |
Schedule of debt | September 30, 2017 2016 Term loans – Bank $ — $ 2,526,502 Equipment loans 203,710 354,979 Unamortized financing costs — (61,224 ) 203,710 2,820,257 Less: current portion (52,600 ) (586,454 ) Long-term debt $ 151,110 $ 2,233,803 |
Schedule of future maturities of debt | 2018 $ 52,600 2019 151,110 $ 203,710 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments in operating leases | Operating Financing 2018 $ 1,299,664 $ 418,200 2019 1,333,427 418,200 2020 1,353,345 418,200 2021 1,180,967 454,936 2022 372,964 481,176 Thereafter 1,096,012 1,644,018 $ 6,636,379 $ 3,834,730 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Stockholders' Equity Note [Abstract] | |
Schedule of warrants outstanding | Outstanding Exercise Expiration date Series A warrants 3,333,333 $ 6.60 February 18, 2018 Series B warrants 3,333,333 $ 8.50 May 18, 2018 Common stock warrants issued with IPO 817,838 $ 0.01 November 11, 2019 Common stock warrants issued with senior secured notes 3,521,501 $ 3.00 December 22, 2021 11,006,005 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of stock-based compensation expense | Year ended September 30, 2017 2016 Research and development $ 1,001,022 $ 2,044,379 General and administrative 7,570,408 10,405,700 $ 8,571,430 $ 12,450,079 Year ended September 30, 2017 2016 Equity-classified compensation $ 8,571,430 $ 10,058,217 Liability-classified compensation — 2,391,862 $ 8,571,430 $ 12,450,079 |
Schedule of performance-based stock units activity | Number of Weighted-Average 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 October 1, 2016 247,309 6.33 Forfeitures (71,779 ) 6.46 Balance at September 30, 2017 175,530 $ 6.27 |
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 October 1, 2016 1,094,351 28.61 Granted 615,000 2.11 Vested and settled (483,913 ) 29.05 Forfeitures (285,559 ) 3.14 Balance at September 30, 2017 939,879 $ 18.78 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of income tax expense (benefit) | Year Ended September 30, 2017 2016 State tax $ 1,500 $ 3,000 Foreign tax provision 500,000 100,000 $ 501,500 $ 103,000 |
Schedule of reconciliation of income tax expense (benefit) at the statutory income tax rate | Year Ended September 30, 2017 2016 U.S. federal statutory rate (34.0 )% (34.0 )% State taxes, net of federal benefit (6.4 ) (5.9 ) Foreign witholding tax 1.3 0.2 Permanent differences (2.8 ) — Foreign tax credits (1.6 ) — Change in valuation allowance 44.8 40.0 Other — (0.1 ) Effective income tax rate 1.3 % 0.2 % |
Schedule of deferred taxes | September 30, 2017 2016 Deferred tax assets Net operating loss carryforwards $ 48,828,141 $ 36,146,789 Stock compensation 14,098,985 11,249,314 Deferred revenue 3,017,238 2,542,558 Research and development credit carryforward 757,701 757,701 Foreign tax credits 2,857,309 2,257,309 Accruals and others 1,539,943 1,287,592 Gross deferred tax assets 71,099,317 54,241,263 Less: valuation allowance (69,902,446 ) (52,737,104 ) 1,196,871 1,504,159 Deferred tax liability: Fixed assets (1,196,871 ) (1,504,159 ) Net deferred tax assets $ — $ — |
Schedule of reconciliation of unrecognized tax benefits | Year Ended September 30, 2017 2016 Balance at beginning of year $ 1,854,629 $ 1,754,629 Additions based on tax positions related to the current year 497,500 100,000 Balance at end of year $ 2,352,129 $ 1,854,629 |
Liquidity (Detail Textuals)
Liquidity (Detail Textuals) - USD ($) | Sep. 11, 2017 | Oct. 31, 2017 | May 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Liquidity [Line Items] | |||||
Net proceeds initial public offering | $ 37,074,996 | ||||
Accumulated deficit | $ (186,215,402) | (147,366,275) | |||
Aggregate indebtedness | 13,500,000 | ||||
Notes payable to stockholders | 4,612,500 | 4,612,500 | |||
Proceeds from issuance of notes | 15,000,000 | ||||
Repayment of senior secured bank loans | 2,677,771 | 1,059,034 | |||
Value of shares issued in cash | 1,503,127 | $ 16,137,913 | |||
Proceeds from issuance of Series A convertible preferred stock | $ 3,262,800 | ||||
GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | Subsequent Event | |||||
Liquidity [Line Items] | |||||
Number of share issued | 217,372 | ||||
GMS Tenshi Holdings Pte. Limited | Series B Convertible Preferred Stock | Subsequent Event | |||||
Liquidity [Line Items] | |||||
Aggregate principal amount of notes | $ 1,500,000 | ||||
IPO | |||||
Liquidity [Line Items] | |||||
Value of shares issued in cash | $ 5,833,334 | ||||
IPO | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | |||||
Liquidity [Line Items] | |||||
Number of share issued | 32,628 | ||||
Proceeds from issuance of Series A convertible preferred stock | $ 3,262,800 | ||||
Private Placement | |||||
Liquidity [Line Items] | |||||
Number of share issued | 833,332 | ||||
Private Placement | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | |||||
Liquidity [Line Items] | |||||
Number of share issued | 250,000 | ||||
Value of shares issued in cash | $ 25,000,000 | ||||
Private Placement | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | Subsequent Event | |||||
Liquidity [Line Items] | |||||
Number of share issued | 217,372 | ||||
Value of shares issued in cash | $ 21,737,200 | ||||
Private Placement | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible, the "Securities" | |||||
Liquidity [Line Items] | |||||
Numbers of common stock shares issued for warrants | 16,750,000 | ||||
Private Placement | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible, the "Securities" | Subsequent Event | |||||
Liquidity [Line Items] | |||||
Numbers of common stock shares issued for warrants | 16,750,000 |
Basis of Presentation and Sum35
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Basic Earnings Per Share | ||
Net loss | $ (40,025,870) | $ (63,138,969) |
Common stock outstanding (weighted average) | 24,022,371 | 17,212,983 |
Basic net loss per share | $ (1.67) | $ (3.67) |
Diluted Earnings Per Share | ||
Net loss | $ (40,025,870) | $ (63,138,969) |
Add change in fair value of warrant liability | (3,158,469) | |
Diluted net loss | $ (43,184,339) | $ (63,138,969) |
Common stock outstanding (weighted average) | 24,022,371 | 17,212,983 |
Add shares from dilutive warrants | 19,418 | 0 |
Common stock equivalents | 24,041,789 | 17,212,983 |
Diluted net loss per share (in dollars per share) | $ (1.80) | $ (3.67) |
Basis of Presentation and Sum36
Basis of Presentation and Summary of Significant Accounting Policies (Details 1) - shares | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Performance-based stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 175,530 | 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 | 939,879 | 1,094,269 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 7,484,504 | 8,186,934 |
Basis of Presentation and Sum37
Basis of Presentation and Summary of Significant Accounting Policies (Detail Textuals) | 12 Months Ended | ||
Sep. 30, 2017USD ($)ft² | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | |
Accounting Policies [Abstract] | |||
Certificates of deposit | $ 216,086 | ||
Prepaid research and development | $ 199,740 | 1,979,527 | |
Estimated useful lives | 3 to 10 years | ||
Methods of depreciation and amortization | Straight-line method | ||
Net rentable area | ft² | 82,000 | ||
Error Correction understated in Property and equipment | 1,700,000 | $ 1,700,000 | |
Error Correction decrease in other long-term liabilities | 1,700,000 | $ 1,700,000 | |
Rent expense overstated | 400,000 | ||
Interest expense understated amount | $ 400,000 |
Basis of Presentation and Sum38
Basis of Presentation and Summary of Significant Accounting Policies (Detail Textuals 1) - USD ($) $ in Millions | 12 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Accounting Policies [Abstract] | ||
Increase in property and equipment | $ 1.7 | $ 1.7 |
Increase in other long-term liabilities | 1.7 | $ 1.7 |
Decrease in research and development expenses | 0.3 | |
Decrease in general and administrative expenses | 0.1 | |
Increase in interest expense | $ 0.4 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Fair value measurements recurring basis | Sep. 30, 2017USD ($) |
Level 1 | |
Liabilities | |
Warrant liability | $ 0 |
Level 2 | |
Liabilities | |
Warrant liability | 0 |
Level 3 | |
Liabilities | |
Warrant liability | $ 2,274,954 |
Fair Value Measurements (Deta40
Fair Value Measurements (Details 1) | 12 Months Ended |
Sep. 30, 2017USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance at October 1, 2016 | $ 0 |
Issuance of warrants | 5,493,619 |
Exercise of warrants | (60,196) |
Change in fair value | (3,158,469) |
Balance at September 30, 2017 | $ 2,274,954 |
Fair Value Measurements (Deta41
Fair Value Measurements (Details 2) - Warrant | 12 Months Ended |
Sep. 30, 2017$ / shares | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Risk-free interest rate | 1.77% |
Remaining contractual life of warrant | 4 years 8 months 1 day |
Expected volatility | 82.00% |
Annual dividend yield | 0.00% |
Fair value of common stock | $ 1.37 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 24,733,843 | $ 24,620,493 |
Less: accumulated depreciation and amortization | (8,644,941) | (5,961,940) |
Property and equipment, net | 16,088,902 | 18,658,553 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 11,574,473 | 11,452,858 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 10,032,640 | 10,031,739 |
Computer software and hardware | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 472,054 | 421,206 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,654,675 | $ 2,714,690 |
Property and Equipment (Detai43
Property and Equipment (Details 1) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Property, Plant and Equipment [Line Items] | ||
2,018 | $ 418,200 | |
2,019 | 418,200 | |
2,020 | 418,200 | |
Total future minimum lease payments under capital leases | 3,834,730 | |
Less: current portion | (341,120) | $ (977,248) |
Capital lease obligations, excluding current portion | 28,067 | $ 320,737 |
Laboratory Equipment | ||
Property, Plant and Equipment [Line Items] | ||
2,018 | 367,782 | |
2,019 | 23,896 | |
2,020 | 5,974 | |
Total future minimum lease payments under capital leases | 397,652 | |
Less: amounts representing interest | (28,465) | |
Less: current portion | (341,120) | |
Capital lease obligations, excluding current portion | $ 28,067 |
Property and Equipment (Detail
Property and Equipment (Detail Textuals) - Laboratory Equipment - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization expense | $ 2,692,100 | $ 2,394,279 |
Laboratory equipment under capital leases | 3,692,913 | 3,630,683 |
Accumulated depreciation related to leased equipment | $ 1,061,901 | $ 732,002 |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Term of capital leases | 22 months | |
Capital leases interest rate | 5.00% | |
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, 2017 | Sep. 30, 2016 |
Accrued Liabilities, Current [Abstract] | ||
Compensation | $ 3,688,592 | $ 3,884,386 |
Research and development | 1,637,657 | 1,343,910 |
Interest payable | 1,047,122 | 234,754 |
Deferred offering costs | 0 | 26,028 |
Professional fees | 521,973 | 486,705 |
Director fees | 376,695 | 73,125 |
Other accrued expenses | 65,430 | 73,034 |
Accrued expenses | $ 7,337,469 | $ 6,121,942 |
Stockholder Notes (Details)
Stockholder Notes (Details) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Debt Instrument [Line Items] | ||
Stockholder notes | $ 4,612,500 | $ 4,612,500 |
Less: current portion | (4,612,500) | (4,612,500) |
Long-tem stockholder notes | 0 | 0 |
Restricted stock purchase notes | ||
Debt Instrument [Line Items] | ||
Stockholder notes | 800,000 | 800,000 |
Common stock repurchase note | ||
Debt Instrument [Line Items] | ||
Stockholder notes | 2,812,500 | 2,812,500 |
Working capital notes | ||
Debt Instrument [Line Items] | ||
Stockholder notes | $ 1,000,000 | $ 1,000,000 |
Stockholder Notes (Detail Textu
Stockholder Notes (Detail Textuals) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Debt Instrument [Line Items] | ||
Interest expense related to the stockholder notes | $ 320,000 | $ 589,675 |
Stockholder notes | 4,612,500 | 4,612,500 |
Restricted stock repurchase notes | ||
Debt Instrument [Line Items] | ||
Repurchase of restricted stock in exchange for notes payable | 1,097,750 | |
Stockholder notes | $ 800,000 | 800,000 |
Restricted stock repurchase notes | Minimum | ||
Debt Instrument [Line Items] | ||
Interest rate | 0.00% | |
Restricted stock repurchase notes | Maximum | ||
Debt Instrument [Line Items] | ||
Interest rate | 4.00% | |
Common stock repurchase note | ||
Debt Instrument [Line Items] | ||
Stockholder notes | $ 2,812,500 | 2,812,500 |
Working capital notes | ||
Debt Instrument [Line Items] | ||
Note collateralized by common shares | 300,000 | |
Stockholder notes | $ 1,000,000 | $ 1,000,000 |
Working capital notes | Minimum | ||
Debt Instrument [Line Items] | ||
Interest rate | 0.00% | |
Working capital notes | Maximum | ||
Debt Instrument [Line Items] | ||
Interest rate | 30.00% |
Debt (Details)
Debt (Details) - Senior Secured Notes | Sep. 30, 2017USD ($) |
Debt Instrument [Line Items] | |
Senior secured notes | $ 15,000,000 |
Unamortized debt discount | (1,768,300) |
Senior secured notes | $ 13,231,700 |
Debt (Details 1)
Debt (Details 1) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Debt Disclosure [Abstract] | ||
Term loans - Bank | $ 0 | $ 2,526,502 |
Equipment loans | 203,710 | 354,979 |
Unamortized financing costs | 0 | (61,224) |
Total loans payable | 203,710 | 2,820,257 |
Less: current portion | (52,600) | (586,454) |
Long-term debt | $ 151,110 | $ 2,233,803 |
Debt (Details 2)
Debt (Details 2) | Sep. 30, 2017USD ($) |
Debt Disclosure [Abstract] | |
2,018 | $ 52,600 |
2,019 | 151,110 |
Total debt | $ 203,710 |
Debt (Detail Textuals)
Debt (Detail Textuals) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Sep. 30, 2017 | Apr. 30, 2017 | Jan. 31, 2017 | Dec. 31, 2016 | May 31, 2017 | Dec. 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Debt Instrument [Line Items] | ||||||||
Aggregate principal amount of notes and warrants issued | $ 1,650,000 | |||||||
Repayment of senior secured bank loans | $ 2,677,771 | $ 1,059,034 | ||||||
Bridge note | ||||||||
Debt Instrument [Line Items] | ||||||||
Unsecured bridge notes | $ 1,850,000 | $ 1,850,000 | ||||||
Interest rate | 15.00% | 15.00% | ||||||
Debt Instrument, term | 1 year | |||||||
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. | |||||||
Interest expense | $ 230,824 | $ 287,280 | ||||||
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 | |||||||
Senior Secured Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate | 5.00% | 5.00% | ||||||
Interest expense | $ 4,441,886 | |||||||
Debt instrument, maturity date | Dec. 22, 2017 | |||||||
Warrants to acquire common stock | 2,300,000 | 1,304,500 | 2,300,000 | |||||
Warrants exercise price per share | $ 3 | $ 3 | ||||||
Term of warrants | 5 years | |||||||
Aggregate principal amount of notes and warrants issued | $ 8,350,000 | $ 5,000,000 | ||||||
Maximum number of shares called by warrants | 1,920,500 | |||||||
Proceeds from issuance of secured debt | $ 6,500,000 | |||||||
Initial fair value of warrant liability | 3,300,000 | 1,400,000 | $ 3,300,000 | |||||
Debt issuance costs | 40,000 | $ 3,635 | 40,000 | |||||
Repayment of senior secured bank loans | 2,400,000 | |||||||
Aggregate principal amount of notes | $ 1,500,000 | |||||||
Senior Secured Notes | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate | 5.00% | |||||||
Senior secured promissory note | $ 15,000,000 | $ 10,000,000 | $ 10,000,000 | |||||
Maximum number of shares called by warrants | 1,665,000 |
Commitments (Details)
Commitments (Details) | Sep. 30, 2017USD ($) |
Operating Leases | |
2,018 | $ 1,299,664 |
2,019 | 1,333,427 |
2,020 | 1,353,345 |
2,021 | 1,180,967 |
2,022 | 372,964 |
Thereafter | 1,096,012 |
Total | 6,636,379 |
Financing Arrangement | |
2,018 | 418,200 |
2,019 | 418,200 |
2,020 | 418,200 |
2,021 | 454,936 |
2,022 | 481,176 |
Thereafter | 1,644,018 |
Total | $ 3,834,730 |
Commitments (Detail Textuals)
Commitments (Detail Textuals) | 1 Months Ended | 12 Months Ended | ||
Jul. 30, 2016 | Aug. 31, 2015ft² | Sep. 30, 2017USD ($)ft² | Sep. 30, 2016USD ($) | |
Long-term Purchase Commitment [Line Items] | ||||
Rent expense under operating lease | $ 1,352,708 | $ 1,207,882 | ||
Net rentable area | ft² | 82,000 | |||
Rent expense under the leases | $ 421,028 | 383,864 | ||
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 | $ 209,782 | $ 191,097 | ||
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 | Expires in March 2026 | |||
Net rentable area | ft² | 82,000 | |||
Technology License | ||||
Long-term Purchase Commitment [Line Items] | ||||
Milestone payments amount | $ 353,600 |
Stockholders' Equity (Deficit54
Stockholders' Equity (Deficit) (Details) | 12 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Outstanding | 11,006,005 |
Series A warrants | |
Class of Warrant or Right [Line Items] | |
Outstanding | 3,333,333 |
Exercise price per share | $ / shares | $ 6.60 |
Expiration date | Feb. 18, 2018 |
Series B warrants | |
Class of Warrant or Right [Line Items] | |
Outstanding | 3,333,333 |
Exercise price per share | $ / shares | $ 8.50 |
Expiration date | May 18, 2018 |
Common stock warrants issued with IPO | |
Class of Warrant or Right [Line Items] | |
Outstanding | 817,838 |
Exercise price per share | $ / shares | $ 0.01 |
Expiration date | Nov. 11, 2019 |
Common stock warrants issued with senior secured notes | |
Class of Warrant or Right [Line Items] | |
Outstanding | 3,521,501 |
Exercise price per share | $ / shares | $ 3 |
Expiration date | Dec. 22, 2021 |
Stockholders' Equity (Deficit55
Stockholders' Equity (Deficit) (Detail Textuals) - USD ($) | Mar. 08, 2017 | Sep. 30, 2017 | Sep. 30, 2016 |
Stockholders' Equity (Deficit) [Line Items] | |||
Value of shares issued in cash | $ 1,503,127 | $ 16,137,913 | |
Lincoln Park Capital, LLC | |||
Stockholders' Equity (Deficit) [Line Items] | |||
Value of common stock shares authorized to purchase | $ 15,400,000 | ||
Shares issued during period | 737,817 | ||
Additional value of shares obligated to issue | $ 15,000,000 | ||
Closing price | $ 1.50 | ||
Number of shares purchase by sole discretion on any business day | 30,000 | ||
Description of transaction | The price per share for such purchases will be equal to the lower of: (i) the lowest sale price on the applicable purchase date and (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive business days ending on the business day immediately preceding such purchase date (in each case, to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction that occurs on or after the date of the purchase agreement). | ||
Maximum amount of shares purchase increased as increase in share price | $ 1,000,000 | ||
Beneficial ownership percentage | 4.99% | ||
Value of shares issued in cash | $ 1,620,931 | ||
Payment for stock issuance cost | $ 147,540 | ||
Additional shares of common stock issued | 122,418 | ||
Lincoln Park Capital, LLC | Purchase agreement | |||
Stockholders' Equity (Deficit) [Line Items] | |||
Shares issued during period | 113,205 | ||
Sale of Series A convertible preferred, net of costs (in shares) | 113,206 |
Stockholders' Equity (Deficit56
Stockholders' Equity (Deficit) (Detail Textuals 1) - USD ($) | 1 Months Ended | 4 Months Ended | 12 Months Ended | ||
May 31, 2016 | Jan. 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stockholders Equity [Line Items] | |||||
Proceeds from the sale of common stock, net of offering costs | $ 1,607,396 | $ 16,137,913 | |||
Redeemable stock, shares issued | 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, net of offering costs | $ 33,784,205 | ||||
Common stock | |||||
Stockholders Equity [Line Items] | |||||
Shares issued during period | 573,388 | 737,817 | 573,388 | ||
Shares issued, price per share | $ 29.05 | ||||
Proceeds from the sale of common stock, net of offering costs | $ 16,137,913 | ||||
Common stock | IPO and private placement | |||||
Stockholders Equity [Line Items] | |||||
Shares issued during period | 833,332 |
Stockholders' Equity (Deficit57
Stockholders' Equity (Deficit) (Detail Textuals 2) | Sep. 30, 2017$ / sharesshares |
Warrant exercise price 0.01 | |
Class of Warrant or Right [Line Items] | |
Warrants to acquire stock | shares | 704,019 |
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 0.01 |
Warrant exercise price 3.00 | |
Class of Warrant or Right [Line Items] | |
Warrants to acquire stock | shares | 82,999 |
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 3 |
Convertible Preferred Stock (De
Convertible Preferred Stock (Detail Textuals) - USD ($) | Sep. 11, 2017 | Sep. 07, 2017 | Oct. 31, 2017 | May 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Convertible Preferred Stock [Line Items] | ||||||
Proceeds from issuance of Series A convertible preferred stock | $ 3,262,800 | |||||
Recognition of beneficial conversion feature upon issuance of Series A convertible preferred stock | (1,176,743) | |||||
Value of shares issued in cash | $ 1,503,127 | $ 16,137,913 | ||||
Series A Convertible Preferred Stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Dividend rate | 10.00% | |||||
Liquidation preference description | In the event of a liquidation (as defined in the Certificate of Designation) the liquidation preference payable equals the sum of (A) 110% of the stated value per share plus (B) (x) 110% of any accrued but unpaid preferred dividends (as defined in the Certificate of Designation) plus (y) any unpaid participating dividends (as defined in the Certificate of Designation). In the case of a deemed liquidation event (as defined in the Certificate of Designation), the multiplier is increased to 120%. | |||||
Percentage of number of shares of common stock issuable | 110.00% | |||||
Percentage increase in multiplier | 120.00% | |||||
Deemed liquidation event description | Additionally, the holder may require the Company to redeem the Series A Convertible in the event of deemed liquidation event for the sum of (A) 120% of the stated value per share plus (B) (x) 120% of any accrued but unpaid preferred dividends (as defined in the Certificate of Designation) plus (y) any unpaid participating dividends (as defined in the Certificate of Designation), although such redemption may not be made without the consent of the senior secured noteholders if such notes are outstanding at the time of any such redemption. | |||||
Conversion of Series A preferred stock in connection with the initial public offering (in shares) | 1,969,818 | |||||
GMS Tenshi Holdings Pte. Limited | Subsequent Event | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Warrants exercise price per share | $ 0.90 | |||||
Terms of warrant | 8 years | |||||
GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | Subsequent Event | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Number of share issued | 217,372 | |||||
GMS Tenshi Holdings Pte. Limited | Series B Convertible Preferred Stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Convertible preferred stock, shares issued upon conversion | 2,112,676 | |||||
Preferred stock not convertible to common stock description | The Series B Convertible are not convertible into common stock if the holder thereof would beneficially own more than 9.99% of the common stock, or, if during the first six-month period following the closing of the exchange, 7.50%, but automatically converts into common stock in part from time to time if the holder beneficially owns below a certain beneficial ownership threshold of the common stock. | |||||
GMS Tenshi Holdings Pte. Limited | Series B Convertible Preferred Stock | Subsequent Event | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Aggregate principal amount of notes | $ 1,500,000 | |||||
Shares issued, price per share | $ 1 | |||||
IPO | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Value of shares issued in cash | $ 5,833,334 | |||||
IPO | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Number of share issued | 32,628 | |||||
Proceeds from issuance of Series A convertible preferred stock | $ 3,262,800 | |||||
Recognition of beneficial conversion feature upon issuance of Series A convertible preferred stock | $ 1,176,743 | |||||
Private Placement | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Number of share issued | 833,332 | |||||
Private Placement | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Number of share issued | 250,000 | |||||
Shares issued, price per share | $ 100 | |||||
Value of shares issued in cash | $ 25,000,000 | |||||
Convertible preferred stock, shares issued upon conversion | 37,795,948 | |||||
Conversion rate per share | $ 0.90 | $ 0.66 | ||||
Warrants exercise price per share | $ 0.90 | |||||
Terms of warrant | 8 years | |||||
Private Placement | Purchase agreement | GMS Tenshi Holdings Pte. Limited | Series A Convertible Preferred Stock | Subsequent Event | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Number of share issued | 217,372 | |||||
Value of shares issued in cash | $ 21,737,200 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - 2015 Equity Incentive Plan - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 8,571,430 | $ 12,450,079 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 1,001,022 | 2,044,379 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 7,570,408 | $ 10,405,700 |
Stock-Based Compensation (Det60
Stock-Based Compensation (Details 1) - 2015 Equity Incentive Plan - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 8,571,430 | $ 12,450,079 |
Equity-classified compensation | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 8,571,430 | 10,058,217 |
Liability-classified compensation | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 0 | $ 2,391,862 |
Stock-Based Compensation (Det61
Stock-Based Compensation (Details 2) - Performance-based stock units - $ / shares | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Number of PSUs | ||
Balance at October 1 | 247,309 | 687,013 |
Forfeitures | (71,779) | (4,924) |
Exchanged for restricted stock units | (434,780) | |
Balance at September 30 | 175,530 | 247,309 |
Weighted-Average Base Price Per PSU | ||
Balance at October 1 | $ 6.33 | $ 3.45 |
Forfeitures | 6.46 | 4.85 |
Exchanged for restricted stock units | 3.45 | |
Balance at September 30 | $ 6.27 | $ 6.33 |
Stock-Based Compensation (Det62
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 (Det63
Stock-Based Compensation (Details 4) - Restricted stock units - $ / shares | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Number of RSUs | ||
Balance at October 1 | 1,094,351 | 0 |
Granted | 615,000 | 705,311 |
Vested and settled | (483,913) | |
Forfeitures | (285,559) | (2,263) |
Issued in connection with PSU exchange | 391,303 | |
Balance at September 30 | 939,879 | 1,094,351 |
Weighted Average Grant Date Fair Value | ||
Balance at October 1 | $ 28.61 | $ 0 |
Granted | 2.11 | 28.31 |
Vested and settled | 29.05 | |
Forfeitures | 3.14 | 13.78 |
Issued in connection with PSU exchange | 29.05 | |
Balance at September 30 | $ 18.78 | $ 28.61 |
Stock-Based Compensation (Det64
Stock-Based Compensation (Detail Textuals) - shares | Sep. 30, 2017 | Sep. 30, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock, shares, outstanding | 24,933,944 | 22,802,778 |
2011 Equity Incentive Plan | Performance-based stock units | 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 | 175,528 |
Stock-Based Compensation (Det65
Stock-Based Compensation (Detail Textuals 1) - shares | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2015 |
Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares outstanding under the Plan | 939,879 | 1,094,351 | 0 |
2015 Equity Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum number of shares can be issued | 2,638,101 | ||
2015 Equity Incentive Plan | Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares available for grant | 939,879 | ||
Common stock shares outstanding under the Plan | 1,214,309 |
Stock-Based Compensation (Det66
Stock-Based Compensation (Detail Textuals 2) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2015 | Sep. 30, 2017 | Sep. 30, 2016 | |
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 | Corporate valuation in excess of $400 million | ||
Number of PSU exchanged for RSU | 434,780 | ||
Share price | $ 25.74 | ||
Unamortized expense | $ 89,428 | ||
Period for recognition of unamortized expense | 1 year 1 month 6 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 | $ 4,265,887 | ||
Period for recognition of unamortized expense | 10 months 24 days |
Stock-Based Compensation (Det67
Stock-Based Compensation (Detail Textuals 3) - Restricted stock units | 12 Months Ended |
Sep. 30, 2017USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares vested in period | shares | 483,913 |
Unamortized expense | $ | $ 4,265,887 |
Period for recognition of unamortized expense | 10 months 24 days |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period of RSUs | 2 years |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period of RSUs | 4 years |
Collaboration Arrangements (Det
Collaboration Arrangements (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Sep. 30, 2017 | Jul. 31, 2017 | Jun. 30, 2014 | Aug. 31, 2013 | May 31, 2013 | Sep. 30, 2017 | Sep. 30, 2016 | |
Huahai Agreement | |||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||
Revenue reorganization deferred revenue | $ 714,848 | $ 1,175,580 | |||||
Deferred revenue | $ 3,038,102 | 3,038,102 | 3,752,950 | ||||
Huahai Agreement | Substantive milestones | |||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||
Milestone payments received | $ 8,500,000 | ||||||
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 | 261,072 | 421,732 | |||||
Deferred revenue | 1,109,558 | 1,109,558 | 1,370,630 | ||||
IPCA License and Collaboration Agreement | Substantive milestones | |||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||
Milestone payments received | $ 1,000,000 | ||||||
IPCA License and Collaboration Agreement | Non-substantive milestones | |||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||
Milestone payments received | $ 2,400,000 | ||||||
Liomont agreement | |||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||
Milestone payments received | $ 1,000,000 | ||||||
Revenue reorganization deferred revenue | 236,641 | 382,264 | |||||
Deferred revenue | 1,005,724 | 1,005,724 | $ 1,242,365 | ||||
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 | $ 2,000,000 | ||||||
GMS Tenshi Agreement | |||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||
Milestone payments received | 2,500,000 | $ 1,250,000 | |||||
Revenue reorganization deferred revenue | 2,598,958 | ||||||
Deferred revenue | 2,401,042 | $ 2,401,042 | |||||
Additional milestone payments received | $ 2,500,000 | $ 1,250,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | ||
State tax | $ 1,500 | $ 3,000 |
Foreign tax provision | 500,000 | 100,000 |
Income tax expense (benefit) | $ 501,500 | $ 103,000 |
Income Taxes (Details 1)
Income Taxes (Details 1) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal statutory rate | (34.00%) | (34.00%) |
State taxes, net of federal benefit | (6.40%) | (5.90%) |
Foreign withholding tax | 1.30% | 0.20% |
Permanent differences | (2.80%) | 0.00% |
Foreign tax credits | (1.60%) | (0.00%) |
Change in valuation allowance | 44.80% | 40.00% |
Other | 0.00% | (0.10%) |
Effective income tax rate | 1.30% | 0.20% |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Deferred tax assets | ||
Net operating loss carryforwards | $ 48,828,141 | $ 36,146,789 |
Stock compensation | 14,098,985 | 11,249,314 |
Deferred revenue | 3,017,238 | 2,542,558 |
Research and development credit carryforward | 757,701 | 757,701 |
Foreign tax credits | 2,857,309 | 2,257,309 |
Accruals and others | 1,539,943 | 1,287,592 |
Gross deferred tax assets | 71,099,317 | 54,241,263 |
Less: valuation allowance | (69,902,446) | (52,737,104) |
Deferred tax assets net of valuation allowance | 1,196,871 | 1,504,159 |
Deferred tax liability: | ||
Fixed assets | (1,196,871) | (1,504,159) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Details 3)
Income Taxes (Details 3) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 1,854,629 | $ 1,754,629 |
Additions based on tax positions related to the current year | 497,500 | 100,000 |
Balance at end of year | $ 2,352,129 | $ 1,854,629 |
Income Taxes (Detail Textuals)
Income Taxes (Detail Textuals) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Operating Loss Carryforwards [Line Items] | ||
Foreign withholding taxes | $ 500,000 | $ 100,000 |
Research and development tax credit carryforwards | 757,701 | 757,701 |
Foreign tax credit carryforwards | 2,857,309 | 2,257,309 |
Increase in valuation allowance | 17,100,000 | $ 14,100,000 |
New Jersey | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | 69,600,000 | |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | 131,500,000 | |
Research and development tax credit carryforwards | 800,000 | |
Foreign tax credit carryforwards | 2,900,000 | |
Foreign tax credit carryforward included in unrecognized tax benefit | 2,400,000 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credit carryforwards | $ 800,000 |
Subsequent Events (Detail Textu
Subsequent Events (Detail Textuals) - USD ($) | Sep. 07, 2017 | Dec. 31, 2017 | Oct. 31, 2017 | May 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Subsequent Event [Line Items] | ||||||
Value of shares issued in cash | $ 1,503,127 | $ 16,137,913 | ||||
Private Placement | ||||||
Subsequent Event [Line Items] | ||||||
Number of share issued | 833,332 | |||||
Series A Convertible Preferred Stock | GMS Tenshi Holdings Pte. Limited | Private Placement | Purchase agreement | ||||||
Subsequent Event [Line Items] | ||||||
Number of share issued | 250,000 | |||||
Warrants exercise price per share | $ 0.90 | |||||
Terms of warrant | 8 years | |||||
Value of shares issued in cash | $ 25,000,000 | |||||
Series A Convertible, the "Securities" | GMS Tenshi Holdings Pte. Limited | Private Placement | Purchase agreement | ||||||
Subsequent Event [Line Items] | ||||||
Numbers of common stock shares issued for warrants | 16,750,000 | |||||
Subsequent event | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from sale of net operating loss and credits | $ 3,150,000 | |||||
Subsequent event | GMS Tenshi Holdings Pte. Limited | ||||||
Subsequent Event [Line Items] | ||||||
Warrants exercise price per share | $ 0.90 | |||||
Terms of warrant | 8 years | |||||
Subsequent event | Series A Convertible Preferred Stock | GMS Tenshi Holdings Pte. Limited | ||||||
Subsequent Event [Line Items] | ||||||
Number of share issued | 217,372 | |||||
Subsequent event | Series A Convertible Preferred Stock | GMS Tenshi Holdings Pte. Limited | Private Placement | Purchase agreement | ||||||
Subsequent Event [Line Items] | ||||||
Number of share issued | 217,372 | |||||
Value of shares issued in cash | $ 21,737,200 | |||||
Subsequent event | Series A Convertible, the "Securities" | GMS Tenshi Holdings Pte. Limited | Private Placement | Purchase agreement | ||||||
Subsequent Event [Line Items] | ||||||
Numbers of common stock shares issued for warrants | 16,750,000 | |||||
Subsequent event | Series B Convertible Preferred Stock | GMS Tenshi Holdings Pte. Limited | ||||||
Subsequent Event [Line Items] | ||||||
Aggregate principal amount of notes | $ 1,500,000 | |||||
Number of shares issued for notes | 1,500,000 |