Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2018 | Dec. 14, 2018 | Mar. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Outlook Therapeutics, 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 | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding | 85,091,062 | ||
Entity Public Float | $ 15.6 | ||
Document Type | 10-K | ||
Document Period End Date | Sep. 30, 2018 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Current assets: | ||
Cash | $ 1,717,391 | $ 3,185,519 |
Prepaid and other current assets | 1,585,089 | 719,087 |
Total current assets | 3,302,480 | 3,904,606 |
Property and equipment, net | 18,489,976 | 16,088,902 |
Other assets | 491,039 | 740,362 |
Total assets | 22,283,495 | 20,733,870 |
Current liabilities: | ||
Senior secured notes | 13,179,449 | |
Current portion of long-term debt | 66,480 | 52,600 |
Current portion of capital lease obligations | 520,794 | 341,120 |
Stockholder notes | 4,612,500 | 4,612,500 |
Accounts payable | 3,609,607 | 10,954,358 |
Accrued expenses | 6,458,471 | 7,337,469 |
Income taxes payable | 1,856,129 | 2,352,129 |
Deferred revenue | 1,738,603 | 3,087,561 |
Total current liabilities | 32,042,033 | 28,737,737 |
Senior secured notes | 13,231,700 | |
Long-term debt | 98,487 | 151,110 |
Capital lease obligations | 3,453,256 | 28,067 |
Warrant liability | 1,227,225 | 2,274,954 |
Deferred revenue | 2,758,262 | 4,466,865 |
Other liabilities | 3,514,738 | 2,569,971 |
Total liabilities | 43,094,001 | 51,460,404 |
Commitments (Note 9) | ||
Convertible preferred stock: | ||
Total convertible preferred stock | 4,734,416 | 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; 72,220,351 and 24,933,944 shares issued and outstanding at September 30, 2018 and 2017, respectively | 722,204 | 249,339 |
Additional paid-in capital | 190,040,237 | 152,315,088 |
Accumulated deficit | (216,307,363) | (186,215,402) |
Total stockholders' equity (deficit) | (25,544,922) | (33,650,975) |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | 22,283,495 | 20,733,870 |
Series A convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | $ 2,924,441 | |
Series A-1 convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | $ 4,734,416 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2018 | Sep. 30, 2017 |
Series A preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Series A preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Series A preferred stock, shares issued | 0 | 0 |
Series A preferred stock, 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 | 72,220,351 | 24,933,944 |
Common stock, shares, outstanding | 72,220,351 | 24,933,944 |
Series A convertible preferred stock | ||
Convertible stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible stock, shares authorized | 1,000,000 | 1,000,000 |
Convertible stock, shares issued | 0 | 32,628 |
Convertible stock, shares outstanding | 0 | 32,628 |
Series A-1 Convertible Preferred Stock | ||
Convertible stock, par value (in dollars per share) | $ 100 | $ 100 |
Convertible stock, shares authorized | 200,000 | 200,000 |
Convertible stock, shares issued | 60,203 | 0 |
Convertible stock, shares outstanding | 60,203 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||
Collaboration revenues | $ 3,087,560 | $ 3,811,519 |
Operating expenses: | ||
Research and development | 18,504,035 | 23,809,749 |
General and administrative | 14,227,828 | 15,882,033 |
Operating expenses total | 32,731,863 | 39,691,782 |
Loss from operations | (29,644,303) | (35,880,263) |
Interest expense, net | 3,891,250 | 5,625,833 |
Loss on extinguishment of debt | 1,252,353 | |
Change in fair value of warrant liability | (1,047,729) | (3,158,469) |
Loss before income taxes | (33,740,177) | (38,347,627) |
Income tax (benefit) expense | (3,648,216) | 501,500 |
Net loss | (30,091,961) | (38,849,127) |
Recognition of beneficial conversion feature upon issuance of Series A and A-1 convertible preferred stock | (16,022,963) | (1,176,743) |
Series A and A-1 convertible preferred stock dividends and related settlement | (1,903,930) | |
Net loss attributable to common stockholders | $ (48,018,854) | $ (40,025,870) |
Per share information: | ||
Net loss per share of common stock, basic (in dollars per share) | $ (1.22) | $ (1.67) |
Net loss per share of common stock, diluted (in dollars per share) | $ (1.22) | $ (1.80) |
Weighted average shares outstanding, basic (in shares) | 39,457,664 | 24,022,371 |
Weighted average shares outstanding, diluted (in shares) | 39,457,664 | 24,041,789 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) | Series A Convertible Preferred Stock | Series A-1 Convertible Preferred Stock | Series B Convertible Preferred Stock | Common stock | Additional Paid-in Capital | Accumulated Deficit | Total |
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 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Proceeds from exercise of common stock warrants | $ 35 | (35) | |||||
Proceeds from exercise of common stock warrants (in shares) | 3,460 | ||||||
Issuance of vested restricted stock units | $ 8,429 | (8,429) | |||||
Issuance of vested restricted stock units (in shares) | 842,889 | ||||||
Private placement sale of common stock and common stock warrants, net of costs | $ 127,548 | 14,567,572 | 14,695,120 | ||||
Private placement sale of common stock and common stock warrants, net of costs (in shares) | 12,754,766 | ||||||
Sale of Series A convertible preferred stock and common stock warrants, net of costs | $ 14,265,861 | 6,382,181 | 6,382,181 | ||||
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares) | 217,372 | ||||||
Series A convertible preferred stock dividends and related settlement | $ 1,757,093 | (1,740,108) | (1,740,108) | ||||
Series A convertible preferred stock dividends and related settlement (in shares) | 17,571 | ||||||
Conversion of Series A convertible preferred stock into common stock | $ (14,359,816) | $ 315,726 | 14,044,090 | 14,359,816 | |||
Conversion of Series A convertible preferred stock into common stock (in shares) | (208,836) | 31,572,617 | |||||
Conversion of Series A convertible preferred stock into Series A-1 convertible preferred stock | $ (4,587,579) | $ 4,587,579 | |||||
Conversion of Series A convertible preferred stock into Series A-1 convertible preferred stock (in shares) | (58,735) | 58,735 | |||||
Series A-1 convertible preferred stock dividends and related settlement | $ 146,837 | (146,837) | (146,837) | ||||
Series A-1 convertible preferred stock dividends and related settlement (in shares) | 1,468 | ||||||
Conversion of senior secured notes into Series B convertible preferred stock | $ 2,661,972 | 2,661,972 | |||||
Conversion of senior secured notes into Series B convertible preferred stock (in shares) | 1,500,000 | ||||||
Conversion of Series B convertible preferred stock into common stock | $ (2,661,972) | $ 21,127 | 2,640,845 | ||||
Conversion of Series B convertible preferred stock into common stock (in shares) | (1,500,000) | 2,112,675 | |||||
Stock-based compensation expense | 1,985,870 | 1,985,870 | |||||
Net loss | (30,091,961) | (30,091,961) | |||||
Balance at Sep. 30, 2018 | $ 4,734,416 | $ 722,204 | $ 190,040,237 | $ (216,307,363) | $ (25,544,922) | ||
Balance (in shares) at Sep. 30, 2018 | 60,203 | 72,220,351 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
OPERATING ACTIVITIES | ||
Net loss | $ (30,091,961) | $ (38,849,127) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3,054,352 | 2,692,100 |
Loss on extinguishment of debt | 1,252,353 | |
Non-cash interest expense | 1,315,861 | 4,014,633 |
Stock-based compensation | 1,985,870 | 8,571,430 |
Change in fair value of warrant liability | (1,047,729) | (3,158,469) |
Loss on disposal of fixed assets | 61,867 | |
Loss on lease termination | 4,173,682 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (1,419,551) | 2,607,520 |
Other assets | 1,554 | 112,439 |
Accounts payable | (6,714,137) | 5,727,136 |
Accrued expenses | (1,664,843) | 893,526 |
Income taxes payable | (496,000) | 497,500 |
Deferred revenue | (3,057,561) | 1,188,481 |
Other liabilities | (331,413) | 135,910 |
Net cash used in operating activities | (33,039,523) | (15,505,054) |
INVESTING ACTIVITIES | ||
Purchase of property and equipment | (2,781,125) | (292,086) |
Net cash used in investing activities | (2,781,125) | (292,086) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of offering costs | 14,695,120 | 1,607,396 |
Payment of debt issuance costs | (40,000) | |
Proceeds from issuance of Series A convertible preferred stock | 21,737,200 | 3,262,800 |
Proceeds from the sale of senior secured notes and detachable warrants | 15,000,000 | |
Proceeds from exercise of common stock warrants | 253,289 | |
Change in restricted cash | 216,086 | |
Payments of capital leases obligations | (862,906) | (991,028) |
Repayment of debt | (127,736) | (2,677,771) |
Payment of financing costs | (1,089,158) | |
Net cash provided by financing activities | 34,352,520 | 16,630,772 |
Net (decrease) increase in cash | (1,468,128) | 833,632 |
Cash at beginning of year | 3,185,519 | 2,351,887 |
Cash at end of year | 1,717,391 | 3,185,519 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 109,979 | 1,339,644 |
Cash paid for income taxes | 1,500 | |
Supplemental schedule of noncash investing activities: | ||
Purchases of property and equipment in accounts payable and accrued expenses | 816,501 | 68,507 |
Supplemental schedule of noncash financing activities: | ||
Issuance of Series B convertible preferred stock upon conversion of senior secured notes, net of unamortized debt discount | 1,409,619 | |
Issuance of capital lease obligations and debt in connection with purchase of property and equipment | 4,444,095 | 62,230 |
Series A and A-1 convertible preferred stock dividends | 1,886,945 | 16,985 |
Settlement of Series A and A-1 convertible preferred stock dividends upon issuance of Series A and A-1 convertible preferred stock | $ 1,903,930 | |
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, 2018 | |
Organization And Description Of Business [Abstract] | |
Organization and Operations | 1. Organization and Operations Description of the Business Oncobiologics, Inc. was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with an into a Delaware corporation in October 2015, and in November 2018, changed its name to Outlook Therapeutics, Inc. (“Outlook” or the “Company”). The Company is a late clinical-stage biopharmaceutical company focused on developing and commercializing ONS-5010, a complex monoclonal antibody (“mAb”) therapeutic for various ophthalmic indications. The Company is based in Cranbury, New Jersey. |
Liquidity
Liquidity | 12 Months Ended |
Sep. 30, 2018 | |
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 $216.3 million as of September 30, 2018. The Company has substantial indebtedness that includes $13.5 million of senior secured notes that may become due in fiscal 2019 and $4.6 million of unsecured indebtedness, $1.0 million of which is due on demand, and $3.6 million of which matures December 22, 2018. 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. On November 5, 2018, the Company entered into a purchase agreement with BioLexis Pte. Ltd. (“BioLexis”), formerly known as GMS Tenshi Holdings Pte. Limited, a Singapore private limited company, and the Company’s controlling stockholder and strategic partner, providing for the private placement of $20.0 million of shares of its common stock at $0.9327 per share. The closing of the sale of the first two tranches of this private placement for an aggregate of 12,865,872 shares of the Company’s common stock for aggregate cash proceeds of $12.0 million occurred in November and December 2018. The remaining $8.0 is expected to be funded in two equal tranches on January 3, 2019 and February 1, 2019, subject to customary conditions and achieving certain funding milestones as set forth in the purchase agreement. The Company intends to use the net proceeds from the private placement primarily for clinical trials for its lead product candidate, ONS-5010, and for working capital and general corporate purposes, including the agreed repayments on the senior secured notes. Also on November 5, 2018, the Company reached an agreement with the holders of its $13.5 million senior secured notes to extend the maturity of the senior secured notes, up to 12 months, or until December 22, 2019, in exchange for making several payments of principal and interest through August 31, 2019, subject to meeting additional capital raising commitments, with an initial payment of $2.2 million paid on November 7, 2018. As of September 30, 2018, the senior secured notes remain classified as a current liability because raising additional capital is outside the Company’s control. In addition, the Company agreed to make the senior secured notes convertible into common stock at a price of $1.11924 per share (120% of the price per share paid by BioLexis under the purchase agreement) and reduced the exercise price of the warrants held by such holders to $1.50 and extended the expiration of these warrants by three years. On November 30, 2018, the Company received approval from the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer Program to sell approximately $3.7 million of its unused New Jersey net operating losses (“NOLs”) and research and development tax credits (“R&D credits”). The Company expects to receive approximately $3.4 million of proceeds from the sale of the New Jersey NOLs and R&D credits. Management believes that the Company’s existing cash as of September 30, 2018, additional $20.0 million funding from the November BioLexis private placement and anticipated proceeds from the sale of New Jersey NOLs and R&D credits will be sufficient to fund its operations into June 2019, excluding any unscheduled repayment of debt. 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 partners, licensing and/or marketing arrangements with pharmaceutical companies, sale of its development stage product candidates to third parties and public or private 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, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statement of operations as they occur. 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. Fair value of financial instruments At September 30, 2018 and 2017, the Company’s financial instruments included accounts payable, accrued expenses, equipment loans, stockholder notes and senior secured notes. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments. 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, 2018 and 2017. 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, 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, (iii) clinical manufacturing and (iv) 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. Incentive and tax receivables The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable period. The Company’s estimate of the amount of cash refund it expects to receive related to the Australian research and development tax incentive program is included in prepaid and other current assets in the accompanying consolidated balance sheet. As of September 30, 2018, the Company’s estimate of the amount of cash refund it expects to receive in 2019 for 2018 eligible spending as part of this incentive program was $0.3 million. In addition, the Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in prepaid and other current assets in the accompanying consolidated balance sheet. As of September 30, 2018, prepaid and other current assets included $0.1 million for refundable GST on expenses incurred with Australian vendors. 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. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the year ended September 30, 2018, the Company recorded $0.3 million in its consolidated results of operations related to the cash refund it expects to receive from the Australian research and development tax incentive program. 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: Year Ended September 30, 2018 2017 Basic Earnings Per Share Net loss attributable to common stockholders $ (48,018,854 ) $ (40,025,870 ) Common stock outstanding (weighted average) 39,457,664 24,022,371 Basic net loss per share $ (1.22 ) $ (1.67 ) Diluted Earnings Per Share Net loss attributable to common stockholders $ (48,018,854 ) $ (40,025,870 ) Add change in fair value of warrant liability — (3,158,469 ) Diluted net loss (48,018,854 ) (43,184,339 ) Common stock outstanding (weighted average) 39,457,664 24,022,371 Add shares from dilutive warrants — 19,418 Common stock equivalents 39,457,664 24,041,789 Diluted net loss per share $ (1.22 ) $ (1.80 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2018 and 2017, as they would be antidilutive: As of September 30, 2018 2017 Series A-1 convertible preferred stock 9,101,717 — Performance-based stock units 129,095 175,530 Restricted stock units 61,109 939,879 Stock options 1,557,145 — Common stock warrants 45,292,532 7,484,504 Recently issued accounting pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers The new standard will be effective for the Company beginning October 1, 2018 and permits two methods of adoption: the full retrospective method, which requires the standard to be applied to each prior period presented, or the modified retrospective method, which requires the cumulative effect of adoption to be recognized as an adjustment to opening retained earnings in the period of adoption. The Company will adopt the standard using the modified retrospective method. The Company’s arrangements fall under ASC 808, Collaborations, In February 2016, the FASB issued ASU No. 2016-02, Leases In May 2017, the FASB issued ASU No. 2017-09, (Topic 718): . 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, , 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. In June 2018, the FASB issued ASU No. 2018-07, Compensation — Stock Compensation Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Sep. 30, 2018 | |
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, 2018 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 1,227,225 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 years ended September 30, 2018 and 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 Change in fair value (1,047,729 ) Balance at September 30, 2018 $ 1,227,225 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, 2018 2017 Risk-free interest rate 2.90% 1.77% Remaining contractual life of warrant 3.39 years 4.67 years Expected volatility 82% 82% Annual dividend yield 0% 0% Fair value of common stock $0.98 per share $1.37 per share |
Property and Equipment
Property and Equipment | 12 Months Ended |
Sep. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment, net, consists of: September 30, 2018 2017 Laboratory equipment $ 14,333,624 $ 11,574,473 Leasehold improvements 10,095,100 10,032,640 Computer software and hardware 483,807 472,054 Land and building 3,000,000 — Construction in progress 2,276,737 2,654,675 30,189,268 24,733,842 Less: accumulated depreciation and amortization (11,699,292 ) (8,644,940 ) $ 18,489,976 $ 16,088,902 Depreciation and amortization expense for the years ended September 30, 2018 and 2017 was $3,054,352 and $2,692,100, respectively. At September 30, 2018, $7,953,856 represents laboratory equipment under capital leases and the Company’s corporate office that is classified as a capital lease. At September 30, 2017, $3,692,913 represents laboratory equipment under capital leases. At September 30, 2018 and 2017, $1,619,741 and $1,061,901, respectively, of accumulated amortization related to capital leases. The term of the equipment leases are between 12 and 36 months and qualify as capital leases. The equipment leases bear interest between 4.0% and 19.4% and the effective interest rate on the corporate office lease is 43.9%. In February 2018, the Company entered into a sixth amendment to its lease for its corporate offices. Pursuant to the amended terms, the Company is now occupying 100% of the corporate facility and has extended the term through February 2028 with two five year renewal options. As a result of this amendment, the lease is now classified as a capital lease. The Company initially recorded the lease obligation and corresponding building asset based on its estimated fair value of $3,000,000. The building is being depreciated over the lease term. Future lease payments will be allocated to interest expense and a pay-down of the lease obligation. The following is a schedule of future minimum lease payments under capital leases as of September 30, 2018 for the years ending September 30: 2019 $ 1,947,199 2020 1,594,917 2021 1,493,442 2022 1,522,660 2023 1,550,878 Thereafter 7,280,400 15,389,496 Less: amounts representing interest (11,415,446 ) Less: current portion (520,794 ) Capital lease obligations, excluding current portion $ 3,453,256 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Sep. 30, 2018 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consists of: September 30, 2018 2017 Compensation $ 2,231,122 $ 3,688,592 Severance and related costs 396,138 — Lease termination obligation 395,071 — Research and development 1,065,169 1,637,657 Interest payable 1,991,044 1,047,122 Professional fees 313,585 521,973 Director fees 59,122 376,695 Other accrued expenses 7,220 65,430 $ 6,458,471 $ 7,337,469 |
Stockholder Notes
Stockholder Notes | 12 Months Ended |
Sep. 30, 2018 | |
Short-term Debt [Abstract] | |
Stockholder Notes | 7. Stockholder Notes September 30, 2018 2017 Restricted stock repurchase 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 notes which bear interest at rates ranging from 0% to 4% per annum. The Company has a $2,812,500 note payable related to the previous repurchase of common stock that does not bear interest. The Company also 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 former chief executive officer. Of the $4.6 million outstanding under these notes, $1.0 million is due on demand, and $3.6 million matures December 22, 2018. During the years ended September 30, 2018 and 2017, the Company recognized interest expense related to the stockholder notes of $300,000 and $320,000, respectively. |
Debt
Debt | 12 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Debt | 8. Debt Senior secured notes September 30, 2018 2017 Senior secured notes $ 13,500,000 $ 15,000,000 Unamortized debt discount (320,551 ) (1,768,300 ) $ 13,179,449 $ 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 using the effective interest method. 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 were due to 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 using effective interest rate method. 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 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 exchanged $1.5 million aggregate principal amount of senior secured notes for 1,500,000 shares of Series B convertible preferred stock (“Series B Convertible”) and $41,507 of accrued interest on such exchanged senior secured notes in October 2017. The Company recognized a loss on extinguishment of $1,252,353 in connection with the exchange and represents the excess fair value of the Series B Convertible issued over the net carrying amount of the debt and accrued interest. The 1,500,000 shares of Series B Convertible were converted into an aggregate of 2,112,675 shares of common stock in June 2018 and there are no longer any shares of Series B Convertible issued and outstanding. In connection with the November 2018 purchase agreement with BioLexis providing for the private placement of $20.0 million of shares of the Company’s common stock, the Company reached an agreement with the holders of the Notes to further extend the maturity of the Notes up to 12 months, or until December 22, 2019, in exchange for making several payments of principal and interest through August 31, 2019, subject to meeting additional capital raising commitments, of which $2.2 million was paid in November 2018 and $1.17 million was paid in December 2018. At September 30, 2018, the Notes remained classified as a current liability because raising additional capital is outside the Company’s control. In addition, the Company agreed to make the Notes convertible into common stock at a price of $1.11924 per share and reduced the exercise price of the Senior Note Warrants to $1.50 and extended the expiration of the Senior Note Warrants by three years. Interest expense on the Notes for the years ended September 30, 2018 and 2017 was $1,997,231 and $4,441,886, respectively. Other indebtedness In addition to the Notes, the Company has other outstanding debt consisting of equipment loans and unsecured notes. Refer to Note 7 for additional information on unsecured notes. September 30, 2018 2017 Equipment loans $ 164,967 $ 203,710 Less: current portion (66,480 ) (52,600 ) Long-term debt $ 98,487 $ 151,110 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 collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and former chief executive officer. Interest expense on the above loans for the years ended September 30, 2018 and 2017 was $27,660 and $35,608, respectively. Future maturities of other indebtedness at September 30, 2018 are as follows for the years ending September 30: 2019 $ 66,480 2020 48,204 2021 50,283 $ 164,967 |
Commitments
Commitments | 12 Months Ended |
Sep. 30, 2018 | |
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 the Company’s bankruptcy, insolvency or similar circumstances. MTTR — Strategic partnership agreement (ONS-5010) In February 2018, the Company entered into a strategic partnership agreement with MTTR, LLC, or MTTR, to advise on regulatory, clinical and commercial strategy and assist in obtaining approval of ONS-5010, the Company’s bevacizumab therapeutic product candidate for ophthalmic indications. Under the terms of the agreement, the Company currently pays MTTR a $58,333 monthly consulting fee. Beginning January 2019, the monthly fee increases to $105,208 per month, and then, after launch of ONS-5010 in the United States, to $170,833 per month (the amount of which is reduced by 50% in the event net sales of ONS-5010 are below a certain threshold million per year). The Company also agreed to pay MTTR a tiered percentage of the net profits of ONS-5010 ranging in the low- to mid-teens, with the ability to credit monthly fees paid to MTTR. In March 2018, the Company amended the MTTR agreement and agreed to pay a one-time fee of $268,553 to MTTR by September 2020 if certain regulatory milestones are achieved earlier than anticipated. For the year ended September 30, 2018, MTTR earned an aggregate of $602,629, which includes monthly consulting fees, expense reimbursement and an initial upfront payment of $75,000. Technology license The Company entered into a technology license agreement with Selexis that will require milestone payments of $353,600 (based on an exchange rate on September 30, 2018 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 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 was due to expire in March 2026. Due to the Company’s involvement in the construction required to complete the leased facility, the lease was accounted for as a financing arrangement to which the Company recorded the fair value of the asset in property and equipment and a corresponding liability was 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, 2018 and 2017, the Company recorded interest expense of $390,793 and $421,028, respectively. In August 2018, the Company entered into a lease termination agreement effective September 1, 2018, to terminate the lease for office and laboratory space in Cranbury, New Jersey. In consideration for the termination of the lease, the Company agreed to make payments to the landlord totaling up to $5.8 million, which includes (i) $287,615 upon execution of the termination agreement, (ii) $50,000 per month for up to 30 months, commencing September 1, 2018, and (iii) a $4.0 million payment, in any event, on or before February 1, 2021. The Company and landlord agreed that the $174,250 security deposit will be used to pay the 7 th th th th In connection with the lease termination, the Company recorded a $4.2 million liability at September 1, 2018, the cease-use date, that represents the present value of the future termination payments. The Company derecognized the assets and liabilities associated with the financing lease and recorded a charge of $4.2 million to general and administrative expense. At September 30, 2018, the current portion of the lease termination obligation of $395,071 is included in accrued expenses and $3,455,010 is included in other liabilities on the consolidated balance sheets. A rollforward of the charges incurred to general and administrative expense for the year ended September 30, 2018 is as follows: Balance Expensed/ Cash Non-Cash Balance Lease termination payments $ — $ 4,187,696 $ (337,615 ) $ — $ 3,850,081 Derecognition of assets and liabilities — (14,014 ) — 14.014 — $ — $ 4,173,682 $ (337,615 ) $ 14,014 $ 3,850,081 Rent expense under operating leases was $854,487 and $1,352,708 for the years ended September 30, 2018 and 2017, respectively. The Company recognizes rent expense on a straight-line basis over the lease period and has accrued for rent expense incurred but not yet paid. Landlord allowances for tenant improvements are deferred and recognized as a reduction to rent expense on a straight line basis and over the remaining lease term. Future minimum payments under noncancelable operating leases at September 30, 2018 are as follows for the years ending September 30: Operating 2019 $ 180,000 2020 187,500 2021 195,000 $ 562,500 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, 2018 and 2017, the expense relating to the matching contribution was $175,693 and $209,782, respectively. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Sep. 30, 2018 | |
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 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. There were no shares sold to Lincoln Park during the year ended September 30, 2018. Common stock In May 2018, the Company entered into a purchase agreement with BioLexis, pursuant to which BioLexis purchased, in a private placement, 12,754,766 shares of common stock and common stock warrants to purchase 20,512,820 shares of common stock for cash proceeds of $15.0 million. The transaction closed in two tranches in May and June 2018. The warrants have an exercise price of $0.975 per share and a term of eight years from their issuance date. During the years ended September 30, 2018 and 2017, the Company issued 842,889 and 483,913 shares of common stock upon the vesting of RSUs, respectively. 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, 2018. Common stock warrants As of September 30, 2018, the Company had the following warrants outstanding to acquire shares of its common stock: Outstanding Exercise Price Per Share Expiration Date 3,333,333 $ 6.60 February 18, 2019 (i) 814,378 $ 0.01 November 11, 2019 3,882,001 $ 3.00 December 22, 2021 (ii) 16,750,000 $ 0.90 October 31, 2025 10,256,410 $ 0.975 May 10, 2026 10,256,410 $ 0.975 June 8, 2026 45,292, 532 (i) In connection with the November 2018 purchase agreement with BioLexis providing for the private placement of $20.0 million of shares of the Company’s common stock, the Company undertook to take such action as necessary to reduce the exercise price of the Series A warrants to $1.50 and extend the expiration date of such Series A warrants by three years. (ii) In November 2018, the Company reduced the exercise price of the Senior Note Warrants to $1.50 and extended the expiration of the Senior Note warrants by three years. Such Senior Note Warrants now expire eight years from their initial issuance date. During the year ended September 30, 2018, warrants to purchase 3,460 shares with an exercise price of $0.01 were exercised. 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, 2018 | |
Equity [Abstract] | |
Convertible Preferred Stock | 11. Convertible Preferred Stock Series A Convertible Preferred Stock In September 2017, the Company entered into a purchase agreement with BioLexis, pursuant to which BioLexis agreed to purchase, in a private placement (the “Initial Private Placement”), $25.0 million of the Company’s newly-created voting Series A Convertible Preferred Stock (the “Series A Convertible”), and warrants (the “BioLexis Warrants” and together with the Series A Convertible, the “Securities”) to acquire 16,750,000 shares of common stock. In September 2017, the Company completed the initial sale of 32,628 shares of Series A Convertible to BioLexis 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 BioLexis Warrants to BioLexis in the Initial Private Placement, for $21,737,200 in cash. The Series A Convertible was initially convertible into 37,795,948 shares of the Company’s common stock, representing an effective conversion rate of $0.66 per share, which represented a discount to the market value of the Company’s common stock as of September 7, 2017 and October 31, 2017 (on which dates, the closing price of the Company’s common stock was $0.90 and $1.26 per share, respectively). In connection with the second closing of the Series A Convertible in October 2017, the Company issued the BioLexis Warrants, which have a term of 8-years and an initial exercise price of $0.90 per share. The proceeds from the second closing of the Series A Convertible were allocated among the Series A Convertible and the BioLexis Warrants based on their relative fair values. As a result of the discount to the market value and the allocation of a portion of the proceeds to the BioLexis Warrants, the Company recognized a beneficial conversion charge of $15,355,019, which represents the in-the-money value of the conversion rate as of the date of sale. The Series A Convertible accrued 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, was payable in December 2017. The Series A Convertible was also 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 was subject to appropriate adjustment in the event of a stock split, stock dividend, combination, reclassification or other recapitalization affecting the common stock. During the year ended September 30, 2018, the Company issued an additional 17,571 shares of Series A Convertible to settle the related dividends that were due on a quarterly basis. The Company recognized a beneficial conversion charge of $597,255 during the year ended September 30, 2018, which represents the in-the-money value of the conversion rate as of the date of issuance. In June 2018, BioLexis converted 208,836 shares of Series A Convertible into 31,572,617 shares of common stock, and in July 2018 exchanged its remaining shares of Series A Convertible for newly created Series A-1 (as defined below). As of such exchange, there were no longer any shares of Series A Convertible issued and outstanding. Series A-1 Convertible Preferred Stock In July 2018, the Company entered into an exchange agreement (the “Exchange Agreement”) with Biolexis, pursuant to which the Company exchanged 58,735 shares of voting Series A Convertible held by BioLexis for 58,735 shares of its newly created series of voting convertible preferred stock, voting Series A-1 Convertible Preferred Stock, (the “Series A-1”). Accordingly, all of the issued Series A Convertible have been retired and cancelled and may not be reissued as shares of such series in accordance with their terms. In connection with the entry into the Exchange Agreement, the Company and BioLexis amended the Investor Rights Agreement dated September 11, 2017, as amended, (the “Second Amendment to Investor Rights Agreement”) in order to provide the Investor certain registration and other rights with respect to the shares of Common Stock to be acquired upon conversion of the Series A-1 issued pursuant to the Exchange Agreement. A total of 200,000 shares of Series A-1 have been authorized for issuance under the Certificate of Designation of Series A-1 Convertible Preferred Stock of the Company. The shares of Series A-1 have a stated value of $100.00 per share, are initially convertible into 8,879,780 shares of the Common Stock and rank senior to all junior securities (as defined in the Certificate of Designation). The Series A-1 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-1. The Series A-1 is also 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-1 have the right to vote on matters submitted to a vote of the Company’s stockholders on an as-converted basis, voting with the Company’s other stockholders as a single class. In addition, without the prior written consent of a majority of the outstanding shares of Series A-1, the Company may not take certain actions, including amending its certificate of incorporation or bylaws, or issuing securities ranking pari passu or senior to the Series A-1. During the year ended September 30, 2018, the Company issued 1,468 shares of Series A-1 Convertible to settle the related dividends that are due on a quarterly basis. The Company recognized a beneficial conversion charge of $70,662 during the year ended September 30, 2018, which represents the in-the-money value of the conversion rate as of the date of issuance. The terms of the Series A-1 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 senior secured 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) 550% of the Series A-1 stated value per share plus (B) an amount equal to (x) 550% 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 600%. The Series A-1 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 550% of the number of shares of common stock issuable based upon the then applicable conversion rate. In the event of a deemed liquidation event, the multiplier is increased to 600%. Additionally, the holder may irrevocably require the Company to redeem the Series A-1 in the event of a deemed liquidation event for the sum of (A) 600% of the Series A-1 stated value per share plus (B) an amount equal to (x) 600% of any accrued, but unpaid, preferred dividends plus (y) any unpaid participating dividends, 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. The shares of Series A-1 have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States without registration or an applicable exemption from the registration requirements of the Securities Act. The exchange of the Series A-1 for the shares of Series A held by the Investor was made in reliance on Sections 3(a)(9) and 4(a)(2) under the Securities Act, without general solicitation or advertising. Series B Convertible Preferred Stock Concurrent with completing the sale of Series A Convertible in October 2017, the Noteholders exchanged $1,500,000 in aggregate principal borrowings and $41,507 in accrued interest for 1,500,000 shares of Series B Convertible. The Series B Convertible were convertible into 2,112,675 shares of common stock. The exchange was accounted for as an extinguishment of debt, See Note 8. During May and June 2018, the Noteholders converted all 1,500,000 shares of Series B Convertible into 2,112,675 shares of common stock. Accordingly, there are no longer any shares of Series B Convertible issued and outstanding. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Sep. 30, 2018 | |
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, 2018, performance-based stock unit awards (“PSUs”) representing 129,095 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. As of September 30, 2018, the maximum number of shares of common stock that may be issued under the 2015 Plan is 8,404,023 shares and 5,558,678 shares remained available for grant under the 2015 Plan. The Company recognizes the grant date fair value of each stock-based award over the vesting period of the award. The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations for the years ended September 30, 2018 and 2017: Year Ended Ended September 30, 2018 2017 Research and development $ 19,450 $ 1,001,022 General and administrative 1,966,420 7,570,408 $ 1,985,870 $ 8,571,430 Stock options The following table summarizes all of the Company’s stock option activity for the year ended September 30, 2018: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Balance at October 1, 2017 — $ — Granted 1,667,075 0.93 Expired/forfeited/cancelled (209,930 ) 1.10 Balance at September 30, 2018 1,457,145 0.93 9.7 Vested and exercisable 30,000 1.32 0.1 Vested and expected to vest at September 30, 2018 1,457,145 $ 0.90 9.7 As of September 30, 2018, the aggregate intrinsic value of the stock options was $131,442. The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model, wherein expected volatility is based on historical volatility of the publicly traded common stock of a peer group of companies. The expected term calculation is based on the “simplified” method described in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment Share-Based Payment The weighted-average grant date fair value of the options awarded to employees for the year ended September 30, 2018 was $0.56 per share. The following table presents the weighted-average assumptions used in the option pricing model for stock options: Year Ended September 30, 2018 Risk-free interest rate 2.80% Expected life 6.0 years Expected volatility 71% Expected dividend yield — As of September 30, 2018, there was $726,930 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 3.1 years. 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, 2018 and 2017: Number of PSUs Base Price Per PSU Balance at October 1, 2016 247,309 $ 6.33 Forfeitures (71,779 ) 6.46 Balance at October 1, 2017 175,530 6.27 Forfeitures (46,435 ) 6.43 Balance at September 30, 2018 129,095 6.25 Vested and exercisable 128,660 6.23 Vested and expected to vest at September 30, 2018 129,095 $ 6.25 As of September 30, 2018, there was $1,552 of unamortized expense that will be recognized over a weighted-average period of 0.4 years. Restricted stock units The Company has granted RSUs that generally vest over a period of two to four years from the date of grant. The following table summarizes the activity related to RSUs during the years ended September 30, 2018 and 2017: Number of RSUs Weighted Average Grant Date Fair Value Balance at October 1, 2016 1,094,351 $ 28.61 Granted 615,000 2.11 Vested and settled (483,913 ) 29.05 Forfeitures (285,559 ) 3.14 Balance at October 1, 2017 939,879 18.78 Granted 20,000 1.16 Vested and settled (842,889 ) 18.40 Forfeitures (55,881 ) 17.67 Balance at September 30, 2018 61,109 $ 19.23 As of September 30, 2018, there was $544,691 of unamortized expense that will be recognized over a weighted-average period of 0.95 years. |
Collaboration Arrangements
Collaboration Arrangements | 12 Months Ended |
Sep. 30, 2018 | |
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 each of the years ended September 30, 2018 and 2017, the Company recognized $714,848 of deferred revenues. As of September 30, 2018 and 2017, deferred revenue included in the Company’s consolidated balance sheet related to the Huahai arrangement was $2,323,254 and $3,038,102, 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. As of September 30, 2018, the Company has received an aggregate of $5.0 million of payments from IPCA under its various agreements. During each of the years ended September 30, 2018 and 2017, the Company recognized deferred revenues of $261,072. As of September 30, 2018 and 2017, deferred revenue included in the Company’s consolidated balance sheets was $848,486 and $1,109,558, 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. As of September 30, 2018, the Company has received an aggregate of $3.0 million of upfront and milestone payments from Liomont. During the years ended September 30, 2018 and 2017, the Company recognized deferred revenue of $236,641 for both periods, respectively. As of September 30, 2018 and 2017, deferred revenue included in the Company’s consolidated balance sheets was $769,083 and $1,005,724. BioLexis Agreement In July 2017, the Company entered into a strategic licensing agreement with BioLexis, under which it granted BioLexis and its affiliates a perpetual, irrevocable, exclusives 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 BioLexis of $1.25 million, and an additional $1.25 million upon meeting a notice and acknowledgment milestone. In September 2017 the Company and BioLexis 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 BioLexis 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, BioLexis 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 BioLexis’ favor, subject to adjustment as provided in the agreement. During the years ended September 30, 2018 and 2017, the Company recognized revenue of $1,874,999 and $2,598,958, respectively, under the BioLexis agreements. As of September 30, 2018 and 2017, deferred revenue included in the Company’s consolidated balance sheet was $526,042 and $2,401,042, respectively. |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Sep. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 14. Related-Party Transactions In May 2018, the Company negotiated a contract with Sonnet Biotherapeutics, Inc. (“Sonnet”) to provide contract development and manufacturing (“CDMO”) services. The maximum contract value is estimated to be approximately $5.1 million, if all milestones are met. Additionally, in order to provide services to Sonnet and other potential CDMO customers, in November 2017, the Company acquired laboratory and office equipment from Sonnet with a value of $115,000 and during the year ended September 30, 2018, assumed leases of $201,000 for equipment necessary for the planned expansion of the Company’s development and manufacturing facilities. Such leases were personally guaranteed by Pankaj Mohan, Ph.D., the Company’s former chairman and chief executive officer, and current Class III director. Dr. Mohan and Mr. Donald Griffith, Class II Director, are members of the board of directors of Sonnet, with Dr. Mohan serving as executive chairman of Sonnet. In addition, Dr. Mohan is a significant stockholder of Sonnet and Mr. Griffith is the president, chief executive officer and chief financial officer, of Sonnet. For other related party transactions during the year ended September 30, 2018 and 2017, refer to the Stockholder Notes (Note 7), Debt (Note 8) and the BioLexis Agreement (Note 13). |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income Taxes Income tax (benefit) expense for the years ended September 30, 2018 and 2017 consists of the following: Year Ended September 30, 2018 2017 State tax $ (3,148,216 ) $ 1,500 Foreign tax (500,000 ) 500,000 $ (3,648,216 ) $ 501,500 During the year ended September 30, 2018, the Company sold New Jersey NOLs in the amount of $38,470,278 resulting in the recognition of income tax benefits of $3,150,716. 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, 2018 2017 U.S. federal statutory rate (24.3 )% (34.0 )% State taxes, net of federal benefit (6.9 ) (6.4 ) Sale of New Jersey net operating losses (7.1 ) — Net operating loss 8.0 — Change in tax rates 66.6 — Foreign witholding tax (1.5 ) 1.3 Permanent differences (0.6 ) (2.8 ) Foreign tax credits 1.5 (1.6 ) Research and development credit (22.9 ) — Change in valuation allowance (23.7 ) 44.8 Other 0.1 — Effective income tax rate (10.8 )% 1.3 % The tax effects of the temporary differences that gave rise to deferred taxes were as follows: September 30, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 39,532,689 $ 48,828,141 Stock-based compensation 10,227,514 14,098,985 Deferred revenue 1,264,069 3,017,238 Research and development credit carryforward 8,491,452 757,701 Foreign tax credits 2,357,309 2,857,309 Accruals and others 605,173 1,539,943 Gross deferred tax assets 62,478,206 71,099,317 Less: valuation allowance (61,893,959 ) (69,902,446 ) 584,247 1,196,871 Deferred tax liability: Fixed assets (584,247 ) (1,196,871 ) Net deferred tax assets $ — $ — As of September 30, 2018, the Company has approximately $164.7 million and $68.1 million of federal and New Jersey NOLs that will begin to expire in 2030 and 2036, respectively. As of September 30, 2018, the Company has approximately $0.4 million of foreign net operating losses with no expiration. As of September 30, 2018, the Company has federal and state research and development tax credit carryforwards of $6.6 million and $1.9 million available, respectively, to reduce future tax liabilities which will begin to expire in 2032 and 2023 respectively. As of September 30, 2018, the Company has Federal foreign tax credit carryforwards of $2.4 million available to reduce future tax liabilities that will begin to expire starting in 2023, which 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, 2018 and 2017. The valuation allowance decreased $8.0 million during the year ended September 30, 2018 and increased $17.2 million during the year ended September 30, 2017. 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. The 2017 Tax Cuts and Jobs Act, which was signed into law on December 22, 2017, has resulted in significant changes to the U.S. corporate income tax system. These changes include a federal statutory rate reduction from 34% to 21%, the elimination or reduction of certain domestic deductions and credits and limitations on the deductibility of interest expense and executive compensation. For the fiscal year ending September 30, 2018, the federal tax rate is 24.3%. The 2017 Tax Cuts and Jobs Act also transitions international taxation from a worldwide system to a modified territorial system and includes base erosion prevention measures on non-U.S. earnings, which has the effect of subjecting certain earnings of the Company’s foreign subsidiaries to U.S. taxation as global intangible low-taxed income. These changes are effective beginning in 2018. In regard to the change in the federal tax rate as it relates to the Company’s deferred tax assets and liabilities, the Company has decreased its related deferred tax assets by $22.4 million along with a corresponding offset against the valuation allowance for these deferred tax assets. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Year Ended September 30, 2018 2017 Balance at beginning of year $ 2,352,129 $ 1,854,629 Changes based on tax positions related to the current year (496,000 ) 497,500 Balance at end of year $ 1,856,129 $ 2,352,129 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 2017 remain open for examination by the Internal Revenue Service as well as various states and municipalities. Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company’s net operating loss carryforwards may be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carryforward 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. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statement of operations as they occur. |
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. |
Fair value of financial instruments | Fair value of financial instruments At September 30, 2018 and 2017, the Company’s financial instruments included accounts payable, accrued expenses, equipment loans, stockholder notes and senior secured notes. The carrying amount of accounts payable and accrued expenses approximates fair value due to the short-term maturities of these instruments. |
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, 2018 and 2017. |
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, 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, (iii) clinical manufacturing and (iv) 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. |
Incentive and tax receivables | Incentive and tax receivables The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable period. The Company’s estimate of the amount of cash refund it expects to receive related to the Australian research and development tax incentive program is included in prepaid and other current assets in the accompanying consolidated balance sheet. As of September 30, 2018, the Company’s estimate of the amount of cash refund it expects to receive in 2019 for 2018 eligible spending as part of this incentive program was $0.3 million. In addition, the Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in prepaid and other current assets in the accompanying consolidated balance sheet. As of September 30, 2018, prepaid and other current assets included $0.1 million for refundable GST on expenses incurred with Australian vendors. |
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. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the year ended September 30, 2018, the Company recorded $0.3 million in its consolidated results of operations related to the cash refund it expects to receive from the Australian research and development tax incentive program. |
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: Year Ended September 30, 2018 2017 Basic Earnings Per Share Net loss attributable to common stockholders $ (48,018,854 ) $ (40,025,870 ) Common stock outstanding (weighted average) 39,457,664 24,022,371 Basic net loss per share $ (1.22 ) $ (1.67 ) Diluted Earnings Per Share Net loss attributable to common stockholders $ (48,018,854 ) $ (40,025,870 ) Add change in fair value of warrant liability — (3,158,469 ) Diluted net loss (48,018,854 ) (43,184,339 ) Common stock outstanding (weighted average) 39,457,664 24,022,371 Add shares from dilutive warrants — 19,418 Common stock equivalents 39,457,664 24,041,789 Diluted net loss per share $ (1.22 ) $ (1.80 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2018 and 2017, as they would be antidilutive: As of September 30, 2018 2017 Series A-1 convertible preferred stock 9,101,717 — Performance-based stock units 129,095 175,530 Restricted stock units 61,109 939,879 Stock options 1,557,145 — Common stock warrants 45,292,532 7,484,504 |
Recently issued accounting pronouncements | Recently issued accounting pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers The new standard will be effective for the Company beginning October 1, 2018 and permits two methods of adoption: the full retrospective method, which requires the standard to be applied to each prior period presented, or the modified retrospective method, which requires the cumulative effect of adoption to be recognized as an adjustment to opening retained earnings in the period of adoption. The Company will adopt the standard using the modified retrospective method. The Company’s arrangements fall under ASC 808, Collaborations, In February 2016, the FASB issued ASU No. 2016-02, Leases In May 2017, the FASB issued ASU No. 2017-09, (Topic 718): . 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, , 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. In June 2018, the FASB issued ASU No. 2018-07, Compensation — Stock Compensation Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of computation of basic earnings per share and diluted earnings per share | Year Ended September 30, 2018 2017 Basic Earnings Per Share Net loss attributable to common stockholders $ (48,018,854 ) $ (40,025,870 ) Common stock outstanding (weighted average) 39,457,664 24,022,371 Basic net loss per share $ (1.22 ) $ (1.67 ) Diluted Earnings Per Share Net loss attributable to common stockholders $ (48,018,854 ) $ (40,025,870 ) Add change in fair value of warrant liability — (3,158,469 ) Diluted net loss (48,018,854 ) (43,184,339 ) Common stock outstanding (weighted average) 39,457,664 24,022,371 Add shares from dilutive warrants — 19,418 Common stock equivalents 39,457,664 24,041,789 Diluted net loss per share $ (1.22 ) $ (1.80 ) |
Schedule of dilutive securities excluded from the computation weighted-average shares | As of September 30, 2018 2017 Series A-1 convertible preferred stock 9,101,717 — Performance-based stock units 129,095 175,530 Restricted stock units 61,109 939,879 Stock options 1,557,145 — Common stock warrants 45,292,532 7,484,504 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | September 30, 2018 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 1,227,225 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 Change in fair value (1,047,729 ) Balance at September 30, 2018 $ 1,227,225 |
Schedule of fair value of the warrant liability estimated using Black-Scholes option pricing model | September 30, 2018 2017 Risk-free interest rate 2.90% 1.77% Remaining contractual life of warrant 3.39 years 4.67 years Expected volatility 82% 82% Annual dividend yield 0% 0% Fair value of common stock $0.98 per share $1.37 per share |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | September 30, 2018 2017 Laboratory equipment $ 14,333,624 $ 11,574,473 Leasehold improvements 10,095,100 10,032,640 Computer software and hardware 483,807 472,054 Land and building 3,000,000 — Construction in progress 2,276,737 2,654,675 30,189,268 24,733,842 Less: accumulated depreciation and amortization (11,699,292 ) (8,644,940 ) $ 18,489,976 $ 16,088,902 |
Schedule of future minimum lease payments under capital leases | 2019 $ 1,947,199 2020 1,594,917 2021 1,493,442 2022 1,522,660 2023 1,550,878 Thereafter 7,280,400 15,389,496 Less: amounts representing interest (11,415,446 ) Less: current portion (520,794 ) Capital lease obligations, excluding current portion $ 3,453,256 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Accrued Expenses [Abstract] | |
Schedule of accrued expenses | September 30, 2018 2017 Compensation $ 2,231,122 $ 3,688,592 Severance and related costs 396,138 — Lease termination obligation 395,071 — Research and development 1,065,169 1,637,657 Interest payable 1,991,044 1,047,122 Professional fees 313,585 521,973 Director fees 59,122 376,695 Other accrued expenses 7,220 65,430 $ 6,458,471 $ 7,337,469 |
Stockholder Notes (Tables)
Stockholder Notes (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Short-term Debt [Abstract] | |
Schedule of stockholder notes | September 30, 2018 2017 Restricted stock repurchase 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, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Senior Secured Notes debt | September 30, 2018 2017 Senior secured notes $ 13,500,000 $ 15,000,000 Unamortized debt discount (320,551 ) (1,768,300 ) $ 13,179,449 $ 13,231,700 |
Schedule of debt | September 30, 2018 2017 Equipment loans $ 164,967 $ 203,710 Less: current portion (66,480 ) (52,600 ) Long-term debt $ 98,487 $ 151,110 |
Schedule of future maturities of other indebtedness | 2019 $ 66,480 2020 48,204 2021 50,283 $ 164,967 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments in operating leases | Balance Expensed/ Cash Non-Cash Balance Lease termination payments $ — $ 4,187,696 $ (337,615 ) $ — $ 3,850,081 Derecognition of assets and liabilities — (14,014 ) — 14.014 — $ — $ 4,173,682 $ (337,615 ) $ 14,014 $ 3,850,081 |
Schedule of future termination payment derecognized assets and liabilities associated with financing lease | Operating 2019 $ 180,000 2020 187,500 2021 195,000 $ 562,500 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule of warrants outstanding | Outstanding Exercise Price Expiration Date 3,333,333 $ 6.60 February 18, 2019 (i) 814,378 $ 0.01 November 11, 2019 3,882,001 $ 3.00 December 22, 2021 (ii) 16,750,000 $ 0.90 October 31, 2025 10,256,410 $ 0.975 May 10, 2026 10,256,410 $ 0.975 June 8, 2026 45,292, 532 (i) In connection with the November 2018 purchase agreement with BioLexis providing for the private placement of $20.0 million of shares of the Company’s common stock, the Company undertook to take such action as necessary to reduce the exercise price of the Series A warrants to $1.50 and extend the expiration date of such Series A warrants by three years. (ii) In November 2018, the Company reduced the exercise price of the Senior Note Warrants to $1.50 and extended the expiration of the Senior Note warrants by three years. Such Senior Note Warrants now expire eight years from their initial issuance date. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of stock-based compensation expense | Year Ended Ended September 30, 2018 2017 Research and development $ 19,450 $ 1,001,022 General and administrative 1,966,420 7,570,408 $ 1,985,870 $ 8,571,430 |
Schedule of stock option activity | Number of Weighted Weighted Balance at October 1, 2017 — $ — Granted 1,667,075 0.93 Expired/forfeited/cancelled (209,930 ) 1.10 Balance at September 30, 2018 1,457,145 0.93 9.7 Vested and exercisable 30,000 1.32 0.1 Vested and expected to vest at September 30, 2018 1,457,145 $ 0.90 9.7 |
Schedule of weighted-average assumptions used in option pricing model for stock options | Year Ended Risk-free interest rate 2.80% Expected life 6.0 years Expected volatility 71% Expected dividend yield — |
Schedule of performance-based stock units activity | Number of Base Price Per Balance at October 1, 2016 247,309 $ 6.33 Forfeitures (71,779 ) 6.46 Balance at October 1, 2017 175,530 6.27 Forfeitures (46,435 ) 6.43 Balance at September 30, 2018 129,095 6.25 Vested and exercisable 128,660 6.23 Vested and expected to vest at September 30, 2018 129,095 $ 6.25 |
Schedule of restricted stock units activity | Number of Weighted 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 October 1, 2017 939,879 18.78 Granted 20,000 1.16 Vested and settled (842,889 ) 18.40 Forfeitures (55,881 ) 17.67 Balance at September 30, 2018 61,109 $ 19.23 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income tax expense | Year Ended September 30, 2018 2017 State tax $ (3,148,216 ) $ 1,500 Foreign tax (500,000 ) 500,000 $ (3,648,216) $ 501,500 |
Schedule of reconciliation of income tax expense (benefit) at the statutory federal income tax rate | Year Ended September 30, 2018 2017 U.S. federal statutory rate (24.3 )% (34.0 )% State taxes, net of federal benefit (6.9 ) (6.4 ) Sale of New Jersey net operating losses (7.1 ) — Net operating loss 8.0 — Change in tax rates 66.6 — Foreign witholding tax (1.5 ) 1.3 Permanent differences (0.6 ) (2.8 ) Foreign tax credits 1.5 (1.6 ) Research and development credit (22.9 ) — Change in valuation allowance (23.7 ) 44.8 Other 0.1 — Effective income tax rate (10.8 )% 1.3 % |
Schedule of deferred taxes | September 30, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 39,532,689 $ 48,828,141 Stock-based compensation 10,227,514 14,098,985 Deferred revenue 1,264,069 3,017,238 Research and development credit carryforward 8,491,452 757,701 Foreign tax credits 2,357,309 2,857,309 Accruals and others 605,173 1,539,943 Gross deferred tax assets 62,478,206 71,099,317 Less: valuation allowance (61,893,959 ) (69,902,446 ) 584,247 1,196,871 Deferred tax liability: Fixed assets (584,247 ) (1,196,871 ) Net deferred tax assets $ — $ — |
Schedule of reconciliation of unrecognized tax benefits | Year Ended September 30, 2018 2017 Balance at beginning of year $ 2,352,129 $ 1,854,629 Changes based on tax positions related to the current year (496,000 ) 497,500 Balance at end of year $ 1,856,129 $ 2,352,129 |
Liquidity (Detail Textuals)
Liquidity (Detail Textuals) | Nov. 07, 2018USD ($)$ / shares | Nov. 05, 2018USD ($)Tranches$ / sharesshares | Nov. 30, 2018USD ($) | May 31, 2018shares | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) |
Liquidity [Line Items] | |||||||
Accumulated deficit | $ (216,307,363) | $ (186,215,402) | |||||
Aggregate indebtedness | 13,500,000 | ||||||
Notes payable to stockholders | 4,612,500 | $ 4,612,500 | |||||
Notes payable to stockholders on due demand | 1,000,000 | ||||||
Notes payable to stockholders on matures | 3,600,000 | ||||||
Proceeds from issuance of private placement | $ 20,000,000 | ||||||
Subsequent Event | |||||||
Liquidity [Line Items] | |||||||
Sale of unused net operating losses and research and development tax credits | $ 3,700,000 | ||||||
Proceeds from sale of net operating losses and research and development tax credits | $ 3,400,000 | ||||||
Private Placement | Purchase agreement | |||||||
Liquidity [Line Items] | |||||||
Number of common stock for private placement | shares | 12,754,766 | ||||||
Private Placement | Purchase agreement | BioLexis | Subsequent Event | |||||||
Liquidity [Line Items] | |||||||
Amount of common stock for private placement | $ 20,000,000 | ||||||
Common stock for private placement, per share | $ / shares | $ 0.9327 | ||||||
Number of common stock for private placement | shares | 12,865,872 | ||||||
Number of tranches | Tranches | 2 | ||||||
Proceeds from common stock for aggregate cash | $ 12,000,000 | ||||||
Initial payment of raising additional capital | $ 2,200,000 | ||||||
Reduced the exercise price of the warrants | $ / shares | $ 1.50 | ||||||
Extended expiration tear of warrants | 3 years | ||||||
Private Placement | Purchase agreement | BioLexis | Subsequent Event | January 3, 2019 and February 1, 2019 | |||||||
Liquidity [Line Items] | |||||||
Remaining common stock for aggregate cash | $ 8,000,000 | ||||||
Private Placement | Purchase agreement | BioLexis | Subsequent Event | Senior secured notes convertible | |||||||
Liquidity [Line Items] | |||||||
Common stock at a price, per share | $ / shares | $ 1.11924 | ||||||
Percentages of price per share paid | 120.00% |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Basic Earnings Per Share | ||
Net loss attributable to common stockholders | $ (48,018,854) | $ (40,025,870) |
Common stock outstanding (weighted average) (in shares) | 39,457,664 | 24,022,371 |
Basic net loss per share | $ (1.22) | $ (1.67) |
Diluted Earnings Per Share | ||
Net loss attributable to common stockholders | $ (48,018,854) | $ (40,025,870) |
Add change in fair value of warrant liability | (3,158,469) | |
Diluted net loss | $ (48,018,854) | $ (43,184,339) |
Common stock outstanding (weighted average) (in shares) | 39,457,664 | 24,022,371 |
Add shares from dilutive warrants | 0 | 19,418 |
Common stock equivalents | 39,457,664 | 24,041,789 |
Diluted net loss per share (in dollars per share) | $ (1.22) | $ (1.80) |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies (Details 1) - shares | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Series A-1 convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 9,101,717 | 0 |
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 | 129,095 | 175,530 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 61,109 | 939,879 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,557,145 | 0 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 45,292,532 | 7,484,504 |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies (Detail Textuals) $ in Millions, $ in Millions | 12 Months Ended | |
Sep. 30, 2018USD ($) | Sep. 30, 2018AUD ($) | |
Accounting Policies [Abstract] | ||
Estimated useful lives | 3 to 10 years | 3 to 10 years |
Methods of depreciation and amortization | straight-line method | straight-line method |
Annual aggregate revenues | $ 20 | |
Estimate of the amount of cash refund eligible spending as part of this incentive program | $ 0.3 | |
Refundable GST on expenses | 0.1 | |
Operations related to cash refund | 0.3 | |
Adjustment to increase to accumulated deficit | $ 3.6 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Fair value measurements recurring basis - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Level 1 | ||
Liabilities | ||
Warrant liability | $ 0 | $ 0 |
Level 2 | ||
Liabilities | ||
Warrant liability | 0 | 0 |
Level 3 | ||
Liabilities | ||
Warrant liability | $ 1,227,225 | $ 2,274,954 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details 1) - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance | $ 2,274,954 | $ 0 |
Issuance of warrants | 5,493,619 | |
Exercise of warrants | (60,196) | |
Change in fair value | (1,047,729) | (3,158,469) |
Balance | $ 1,227,225 | $ 2,274,954 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details 2) | Sep. 30, 2018$ / shares | Sep. 30, 2017$ / shares |
Risk-free interest rate | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 2.90 | 1.77 |
Remaining contractual life of warrant | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Expected term | 3 years 4 months 21 days | 4 years 8 months 1 day |
Expected volatility | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 82 | 82 |
Annual dividend yield | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0 | 0 |
Fair value of common stock | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Fair value | $ 0.98 | $ 1.37 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 30,189,268 | $ 24,733,842 |
Less: accumulated depreciation and amortization | (11,699,292) | (8,644,940) |
Property and equipment, net | 18,489,976 | 16,088,902 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 14,333,624 | 11,574,473 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 10,095,100 | 10,032,640 |
Computer software and hardware | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 483,807 | 472,054 |
Land and building | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,000,000 | 0 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,276,737 | $ 2,654,675 |
Property and Equipment (Detai_2
Property and Equipment (Details 1) - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Property, Plant and Equipment [Line Items] | ||
Less: current portion | $ (520,794) | $ (341,120) |
Capital lease obligations, excluding current portion | 3,453,256 | $ 28,067 |
Laboratory Equipment | ||
Property, Plant and Equipment [Line Items] | ||
2,019 | 1,947,199 | |
2,020 | 1,594,917 | |
2,021 | 1,493,442 | |
2,022 | 1,522,660 | |
2,023 | 1,550,878 | |
Thereafter | 7,280,400 | |
Total future minimum lease payments under capital leases | 15,389,496 | |
Less: amounts representing interest | (11,415,446) | |
Less: current portion | (520,794) | |
Capital lease obligations, excluding current portion | $ 3,453,256 |
Property and Equipment (Detail
Property and Equipment (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | |
Feb. 28, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation and amortization expense | $ 3,054,352 | $ 2,692,100 | |
Corporate office, interest rate | 43.90% | ||
Laboratory Equipment | |||
Property, Plant and Equipment [Line Items] | |||
Laboratory equipment under capital leases | $ 7,953,856 | 3,692,913 | |
Accumulated depreciation related to leased equipment | $ 1,619,741 | $ 1,061,901 | |
Percentages lease occupying corporate facility | 100.00% | ||
Term of two renewal options | 5 years | ||
Lease obligation and corresponding building asset of estimated fair value | $ 3,000,000 | ||
Laboratory Equipment | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Term of capital leases | 12 months | ||
Capital leases interest rate | 4.00% | ||
Laboratory Equipment | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Term of capital leases | 36 months | ||
Capital leases interest rate | 19.40% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Accrued Liabilities, Current [Abstract] | ||
Compensation | $ 2,231,122 | $ 3,688,592 |
Severance and related costs | 396,138 | 0 |
Lease termination obligation | 395,071 | 0 |
Research and development | 1,065,169 | 1,637,657 |
Interest payable | 1,991,044 | 1,047,122 |
Professional fees | 313,585 | 521,973 |
Director fees | 59,122 | 376,695 |
Other accrued expenses | 7,220 | 65,430 |
Accrued expenses | $ 6,458,471 | $ 7,337,469 |
Stockholder Notes (Details)
Stockholder Notes (Details) - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
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, 2018 | Sep. 30, 2017 | |
Debt Instrument [Line Items] | ||
Interest expense related to the stockholder notes | $ 300,000 | $ 320,000 |
Stockholder notes | 4,612,500 | 4,612,500 |
Notes payable to stockholders on due demand | 1,000,000 | |
Notes payable to stockholders on matures | 3,600,000 | |
Restricted stock repurchase notes | ||
Debt Instrument [Line Items] | ||
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] | ||
Stockholder notes | 1,000,000 | $ 1,000,000 |
Working capital notes | Stockholder and former chief executive officer | ||
Debt Instrument [Line Items] | ||
Note collateralized by common shares | $ 300,000 | |
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) - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Debt Instrument [Line Items] | ||
Senior secured notes | $ 13,179,449 | |
Senior Secured Notes | ||
Debt Instrument [Line Items] | ||
Senior secured notes | 13,500,000 | $ 15,000,000 |
Unamortized debt discount | (320,551) | (1,768,300) |
Senior secured notes | $ 13,179,449 | $ 13,231,700 |
Debt (Details 1)
Debt (Details 1) - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Debt Disclosure [Abstract] | ||
Equipment loans | $ 164,967 | $ 203,710 |
Less: current portion | (66,480) | (52,600) |
Long-term debt | $ 98,487 | $ 151,110 |
Debt (Details 2)
Debt (Details 2) | Sep. 30, 2018USD ($) |
Debt Disclosure [Abstract] | |
2,019 | $ 66,480 |
2,020 | 48,204 |
2,021 | 50,283 |
Total debt | $ 164,967 |
Debt (Detail Textuals)
Debt (Detail Textuals) - USD ($) | Nov. 05, 2018 | Jan. 31, 2017 | Dec. 31, 2018 | Nov. 30, 2018 | Jun. 30, 2018 | Oct. 31, 2017 | Apr. 30, 2017 | Dec. 31, 2016 | May 31, 2017 | Dec. 31, 2016 | Sep. 30, 2018 | Sep. 30, 2017 | May 31, 2018 |
Debt Instrument [Line Items] | |||||||||||||
Interest expense | $ 1,997,231 | $ 4,441,886 | |||||||||||
Warrants exercise price per share | $ 1.50 | ||||||||||||
Aggregate principal amount of notes and warrants issued | $ 1,650,000 | ||||||||||||
Repayment of senior secured bank loans | $ 127,736 | 2,677,771 | |||||||||||
Stock issued during period for conversion of convertible securities | 14,359,816 | ||||||||||||
Loss on extinguishment of debt | $ (1,252,353) | ||||||||||||
Conversion rate per share | $ 1.11924 | ||||||||||||
Expiration period of warrant extended | 3 years | ||||||||||||
Subsequent event | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Additional capital raising commitments | $ 1,170,000 | $ 2,200,000 | |||||||||||
Series B Convertible Preferred Stock | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Stock issued during period for conversion of convertible securities | $ 1,500,000 | ||||||||||||
Stock issued during period for conversion of convertible securities (in shares) | 1,500,000 | ||||||||||||
Accrued interest | $ 41,507 | ||||||||||||
Conversion of Series B convertible preferred stock into common stock (in shares) | (1,500,000) | ||||||||||||
Purchase agreement | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Warrants exercise price per share | $ 0.975 | ||||||||||||
Purchase agreement | Private Placement | BioLexis | Subsequent event | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Amount of common stock for private placement | $ 20,000,000 | ||||||||||||
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 | ||||||||||||
Equipment loan | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt instrument, description of collateral | collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and former chief executive officer. | ||||||||||||
Interest expense | $ 27,660 | 35,608 | |||||||||||
Equipment loan | Minimum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt, interest rate | 12.00% | ||||||||||||
Debt Instrument, term | 1 year | ||||||||||||
Equipment loan | Maximum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt, interest rate | 16.00% | ||||||||||||
Debt Instrument, term | 5 years | ||||||||||||
Senior Secured Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Warrants to acquire common stock | 1,304,500 | ||||||||||||
Aggregate principal amount of notes and warrants issued | $ 5,000,000 | ||||||||||||
Initial fair value of warrant liability | 1,400,000 | ||||||||||||
Debt issuance costs | $ 3,635 | ||||||||||||
Senior Secured Notes | Note and Warrant Purchase Agreement (the "NWPA") | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Interest rate | 5.00% | 5.00% | |||||||||||
Debt instrument, maturity date | Dec. 22, 2017 | ||||||||||||
Warrants to acquire common stock | 2,300,000 | 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 | ||||||||||||
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 | $ 3,300,000 | |||||||||||
Debt issuance costs | 40,000 | 40,000 | |||||||||||
Senior Secured Notes | Exchange Agreement | Two existing investors | Series B Convertible Preferred Stock | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Stock issued during period for conversion of convertible securities | $ 1,500,000 | ||||||||||||
Stock issued during period for conversion of convertible securities (in shares) | 1,500,000 | ||||||||||||
Accrued interest | $ 41,507 | ||||||||||||
Loss on extinguishment of debt | $ 1,252,353 | ||||||||||||
Conversion of Series B convertible preferred stock into common stock (in shares) | 2,112,675 | ||||||||||||
Senior Secured Notes | Maximum | Note and Warrant Purchase Agreement (the "NWPA") | |||||||||||||
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) | 12 Months Ended |
Sep. 30, 2018USD ($) | |
Lease Termination Obligation [Roll Forward] | |
Lease termination payments Balance October 1, 2017 | $ 0 |
Lease termination payments expensed accrued expense | 4,187,696 |
Cash payments of lease termination | (337,615) |
Non cash items of lease termination | 0 |
Lease termination payments Balance September 30, 2018 | 3,850,081 |
Derecognition of assets and liabilities Balance October 1, 2017 | 0 |
Derecognition of assets and liabilities expensed accrued expense | (14,014) |
Cash payments of derecognition of assets and liabilities | 0 |
Non cash items of derecognition of assets and liabilities | 14,014 |
Derecognition of assets and liabilities | 0 |
Balance October 1, 2017 | 0 |
Expensed accrued expense | 4,173,682 |
Cash payments | (337,615) |
Non cash items | 14,014 |
Balance September 30, 2018 | $ 3,850,081 |
Commitments (Details 1)
Commitments (Details 1) | Sep. 30, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,019 | $ 180,000 |
2,020 | 187,500 |
2,021 | 195,000 |
Future minimum payments under noncancelable operating leases | $ 562,500 |
Commitments (Detail Textuals)
Commitments (Detail Textuals) | 1 Months Ended | 12 Months Ended | ||||
Aug. 31, 2018USD ($) | Mar. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Aug. 31, 2015ft² | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | |
Long-term Purchase Commitment [Line Items] | ||||||
Rent expense under operating lease | $ 390,793 | $ 421,028 | ||||
Rent expense under the leases | $ 854,487 | 1,352,708 | ||||
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 | $ 175,693 | $ 209,782 | ||||
Consideration for termination of lease | $ 5,800,000 | |||||
Amount of execution of termination agreement | 287,615 | |||||
Payment for lease per month | $ 50,000 | |||||
Terms of payment for lease | 30 months | |||||
Lease payment in any event | $ 4,000,000 | |||||
Date of payment event before | Feb. 1, 2021 | |||||
Security deposit | $ 174,250 | |||||
Final payment of lease obligation | $ 4,000,000 | |||||
Loss on lease termination | (4,173,682) | |||||
Derecognized assets and liabilities associated with financing lease | 4,200,000 | |||||
Accrued expenses | ||||||
Long-term Purchase Commitment [Line Items] | ||||||
Lease termination obligation, current | 395,071 | |||||
Other liabilities | ||||||
Long-term Purchase Commitment [Line Items] | ||||||
Lease termination obligation, non-current | 3,455,010 | |||||
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 agreement | ||||||
Long-term Purchase Commitment [Line Items] | ||||||
Milestone payments amount | 353,600 | |||||
Strategic partnership agreement | MTTR, LLC | ||||||
Long-term Purchase Commitment [Line Items] | ||||||
Milestone payments amount | $ 268,553 | |||||
Monthly consulting fee | $ 58,333 | |||||
Increase monthly fee Beginning February 2019 | 105,208 | |||||
Aggregate amount of monthly consulting fees, expense reimbursement paid | 602,629 | |||||
Payment For Initial Upfront Payment | $ 75,000 | |||||
Strategic partnership agreement | MTTR, LLC | United States | ||||||
Long-term Purchase Commitment [Line Items] | ||||||
Increase monthly fee Beginning February 2019 | $ 170,833 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) (Details) | 12 Months Ended | |
Sep. 30, 2018$ / sharesshares | ||
Class of Warrant or Right [Line Items] | ||
Outstanding | shares | 45,292,532 | |
Exercise price per share | $ / shares | $ 1.50 | |
Series A warrants | ||
Class of Warrant or Right [Line Items] | ||
Outstanding | shares | 3,333,333 | |
Exercise price per share | $ / shares | $ 6.6 | |
Expiration date | Feb. 18, 2019 | [1] |
Common stock warrants with expiration date of November 11, 2019 | ||
Class of Warrant or Right [Line Items] | ||
Outstanding | shares | 814,378 | |
Exercise price per share | $ / shares | $ 0.01 | |
Expiration date | Nov. 11, 2019 | |
Senior Note Warrants | ||
Class of Warrant or Right [Line Items] | ||
Outstanding | shares | 3,882,001 | |
Exercise price per share | $ / shares | $ 3 | |
Expiration date | Dec. 22, 2021 | [2] |
Common stock warrants with expiration date of October 31, 2025 | ||
Class of Warrant or Right [Line Items] | ||
Outstanding | shares | 16,750,000 | |
Exercise price per share | $ / shares | $ 0.9 | |
Expiration date | Oct. 31, 2025 | |
Common stock warrants with expiration date of May 10, 2026 | ||
Class of Warrant or Right [Line Items] | ||
Outstanding | shares | 10,256,410 | |
Exercise price per share | $ / shares | $ 0.975 | |
Expiration date | May 10, 2026 | |
Common stock warrants issued with expiration date of June 8, 2026 | ||
Class of Warrant or Right [Line Items] | ||
Outstanding | shares | 10,256,410 | |
Exercise price per share | $ / shares | $ 0.975 | |
Expiration date | Jun. 8, 2026 | |
[1] | In connection with the November 2018 purchase agreement with BioLexis providing for the private placement of $20.0 million of shares of the Company's common stock, the Company undertook to take such action as necessary to reduce the exercise price of the Series A warrants to $1.50 and extend the expiration date of such Series A warrants by three years. | |
[2] | In November 2018, the Company reduced the exercise price of the Senior Note Warrants to $1.50 and extended the expiration of the Senior Note warrants by three years. Such Senior Note Warrants now expire eight years from their initial issuance date. |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) (Detail Textuals) - USD ($) | Mar. 08, 2017 | Sep. 30, 2017 |
Stockholders' Equity (Deficit) [Line Items] | ||
Value of shares issued in cash | $ 1,503,127 | |
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 (Deficit_4
Stockholders' Equity (Deficit) (Detail Textuals 1) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
May 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | |
Stockholders Equity [Line Items] | |||
Warrants exercise price per share | $ 1.50 | ||
Purchase agreement | |||
Stockholders Equity [Line Items] | |||
Proceeds from issuance of warrants | $ 15 | ||
Term of warrant | 8 years | ||
Warrants exercise price per share | $ 0.975 | ||
Common stock warrants | Purchase agreement | |||
Stockholders Equity [Line Items] | |||
Number of warrants purchase to issued common stock | 20,512,820 | ||
Private Placement | Purchase agreement | |||
Stockholders Equity [Line Items] | |||
Number of common stock for private placement | 12,754,766 | ||
Common stock | |||
Stockholders Equity [Line Items] | |||
Number of common stock issued upon vesting of RSUs | 842,889 | 483,913 |
Stockholders' Equity (Deficit_5
Stockholders' Equity (Deficit) (Detail Textuals 2) - $ / shares | Sep. 30, 2018 | Sep. 30, 2017 |
Class of Warrant or Right [Line Items] | ||
Class of warrant or right, exercise price of warrants or rights | $ 1.50 | |
Warrant exercise price 0.01 | ||
Class of Warrant or Right [Line Items] | ||
Warrants to acquire stock | 3,460 | 704,019 |
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | $ 0.01 |
Warrant exercise price 3.00 | ||
Class of Warrant or Right [Line Items] | ||
Warrants to acquire stock | 82,999 | |
Class of warrant or right, exercise price of warrants or rights | $ 3 |
Convertible Preferred Stock (De
Convertible Preferred Stock (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2018 | Dec. 31, 2017 | Oct. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 07, 2017 | |
Convertible Preferred Stock [Line Items] | ||||||
Proceeds from issuance of private placement | $ 20,000,000 | |||||
Proceeds from issuance of Series A convertible preferred stock | 21,737,200 | $ 3,262,800 | ||||
Beneficial conversion charge | $ 16,022,963 | 1,176,743 | ||||
Value of shares issued in cash | $ 1,503,127 | |||||
Common stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Number of share issued | 737,817 | |||||
Value of shares issued in cash | $ 7,378 | |||||
Conversion of Series A convertible preferred stock into common stock (in shares) | 31,572,617 | |||||
Series A Convertible Preferred Stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Beneficial conversion charge | $ 597,255 | |||||
Conversion of Series A convertible preferred stock into common stock (in shares) | (208,836) | |||||
Series A Convertible Preferred Stock issued to settle dividends | 17,571 | |||||
BioLexis | Series A Convertible Preferred Stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Conversion of Series A convertible preferred stock into common stock (in shares) | 208,836 | |||||
BioLexis | Series A Convertible Preferred Stock | Common stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Convertible preferred stock, shares issued upon conversion | 31,572,617 | |||||
Initial Private Placement | Purchase agreement | BioLexis | Common stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Stock and warrant issued to acquire shares of common stock | 16,750,000 | |||||
Convertible preferred stock, shares issued upon conversion | 37,795,948 | |||||
Conversion rate per share | $ 0.66 | |||||
Closing price | $ 1.26 | $ 0.90 | ||||
Initial Private Placement | Purchase agreement | BioLexis | Series A Convertible Preferred Stock | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Number of share issued | 32,628 | |||||
Value of shares issued in cash | $ 3,262,800 | |||||
Dividend rate | 10.00% | |||||
Initial Private Placement | Purchase agreement | BioLexis | Series A Convertible Preferred Stock And Warrants | ||||||
Convertible Preferred Stock [Line Items] | ||||||
Proceeds from issuance of private placement | $ 25,000,000 | |||||
Number of share issued | 217,372 | |||||
Beneficial conversion charge | $ 15,355,019 | |||||
Value of shares issued in cash | $ 21,737,200 | |||||
Terms of warrant | 8 years | |||||
Series A Convertible Preferred Stock issued to settle dividends | 17,571 |
Convertible Preferred Stock (_2
Convertible Preferred Stock (Detail Textuals 1) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jul. 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | |
Convertible Preferred Stock [Line Items] | |||
Recognition Of Beneficial Conversion Feature Upon Issuance Of Convertible Preferred Stock | $ 16,022,963 | $ 1,176,743 | |
Series A Convertible Preferred Stock | |||
Convertible Preferred Stock [Line Items] | |||
Series A Convertible Preferred Stock issued to settle dividends | 17,571 | ||
Recognition Of Beneficial Conversion Feature Upon Issuance Of Convertible Preferred Stock | $ 597,255 | ||
Series A-1 Convertible Preferred Stock | |||
Convertible Preferred Stock [Line Items] | |||
Recognition Of Beneficial Conversion Feature Upon Issuance Of Convertible Preferred Stock | $ 70,662 | ||
Exchange agreement | BioLexis | Series A Convertible Preferred Stock | |||
Convertible Preferred Stock [Line Items] | |||
Number of share issued | 58,735 | ||
Exchange agreement | BioLexis | Series A-1 Convertible Preferred Stock | |||
Convertible Preferred Stock [Line Items] | |||
Number of share issued | 58,735 | ||
Series A-1 authorized for issuance | 200,000 | ||
Shares Issued, Price Per Share | $ 100 | ||
Convertible preferred stock, shares issued upon conversion | 8,879,780 | ||
Preferred Stock, Dividend Rate, Percentage | 10.00% | ||
Liquidation preference description | Liquidation preference payable equals the sum of (A) 550% of the Series A-1 stated value per share plus (B) an amount equal to (x) 550% 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 600%. | ||
Percentage of stated value per share of preferred stock liquidation preference payable | 550.00% | ||
Percentage of accrued but unpaid preferred dividends | 550.00% | ||
Percentage increase in multiplier in case of deemed liquidation | 600.00% | ||
Deemed liquidation event description | Additionally, the holder may irrevocably require the Company to redeem the Series A-1 in the event of a deemed liquidation event for the sum of (A) 600% of the Series A-1 stated value per share plus (B) an amount equal to (x) 600% of any accrued, but unpaid, preferred dividends plus (y) any unpaid participating dividends, 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. |
Convertible Preferred Stock (_3
Convertible Preferred Stock (Detail Textuals 2) - USD ($) | 1 Months Ended | 2 Months Ended | 12 Months Ended |
Oct. 31, 2017 | Jun. 30, 2018 | Sep. 30, 2018 | |
Convertible Preferred Stock [Line Items] | |||
Stock issued during period for conversion of convertible securities | $ 14,359,816 | ||
Series B Convertible Preferred Stock | |||
Convertible Preferred Stock [Line Items] | |||
Number of stock converted | 1,500,000 | ||
Stock issued during period for conversion of convertible securities | $ 1,500,000 | ||
Conversion of Series A convertible preferred stock into common stock (in shares) | 1,500,000 | ||
Accrued interest | $ 41,507 | ||
Number of stock issued upon conversion | 2,112,675 | 2,112,675 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - 2015 Equity Incentive Plan - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,985,870 | $ 8,571,430 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 19,450 | 1,001,022 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,966,420 | $ 7,570,408 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details 1) | 12 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Number of Shares | |
Balance at October 1, 2017 | shares | 0 |
Granted | shares | 1,667,075 |
Expired/forfeited/cancelled | shares | (209,930) |
Balance at September 30, 2018 | shares | 1,457,145 |
Vested and exercisable | shares | 30,000 |
Vested and expected to vest at September 30, 2018 | shares | 1,457,145 |
Weighted Average Exercise Price | |
Balance at October 1, 2017 | $ / shares | $ 0 |
Granted | $ / shares | 0.93 |
Expired/forfeited/cancelled | $ / shares | 1.10 |
Balance at September 30, 2018 | $ / shares | 0.93 |
Vested and exercisable | $ / shares | 1.32 |
Vested and expected to vest at September 30, 2018 | $ / shares | $ 0.90 |
Weighted Average Remaining Contractual Term (Years) | |
Balance | 9 years 8 months 12 days |
Vested and expected to vest | 1 month 6 days |
Vested and expected to vest at September 30, 2018 | 9 years 8 months 12 days |
Stock-Based Compensation (Det_3
Stock-Based Compensation (Details 2) | 12 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Risk-free interest rate | 2.80% |
Expected life | 6 years |
Expected volatility | 71.00% |
Expected dividend yield | 0.00% |
Stock-Based Compensation (Det_4
Stock-Based Compensation (Details 3) - Performance-based stock units - $ / shares | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Number of PSUs | ||
Balance | 175,530 | 247,309 |
Forfeitures | (46,435) | (71,779) |
Balance | 129,095 | 175,530 |
Vested and exercisable | 128,660 | |
Vested and expected to vest | 129,095 | |
Weighted-Average Base Price Per PSU | ||
Balance | $ 6.27 | $ 6.33 |
Forfeitures | 6.43 | 6.46 |
Balance | 6.25 | $ 6.27 |
Vested and exercisable | 6.23 | |
Vested and expected to vest | $ 6.25 |
Stock-Based Compensation (Det_5
Stock-Based Compensation (Details 4) - Restricted stock units - $ / shares | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Number of RSUs | ||
Balance | 939,879 | 1,094,351 |
Granted | 20,000 | 615,000 |
Vested and settled | (842,889) | (483,913) |
Forfeitures | (55,881) | (285,559) |
Balance | 61,109 | 939,879 |
Weighted Average Grant Date Fair Value | ||
Balance | $ 18.78 | $ 28.61 |
Granted | 1.16 | 2.11 |
Vested and settled | 18.40 | 29.05 |
Forfeitures | 17.67 | 3.14 |
Balance | $ 19.23 | $ 18.78 |
Stock-Based Compensation (Det_6
Stock-Based Compensation (Detail Textuals) - shares | Sep. 30, 2018 | Sep. 30, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock, shares, outstanding | 72,220,351 | 24,933,944 |
2011 Equity Incentive Plan | Officers, Employees, Consultants and Directors | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares of common stock reserved for issuance | 1,159,420 | |
Common stock, shares, outstanding | 129,095 | |
2015 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares of common stock reserved for issuance | 8,404,023 | |
Number of shares available for grant | 5,558,678 |
Stock-Based Compensation (Det_7
Stock-Based Compensation (Detail Textuals 1) - Stock options | 12 Months Ended |
Sep. 30, 2018USD ($)$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Aggregate intrinsic value | $ 131,442 |
Vesting term | 10 years |
Share price | $ / shares | $ 0.56 |
Unamortized expense | $ 726,930 |
Period for recognition of unamortized expense | 3 years 1 month 6 days |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 2 years |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 4 years |
Stock-Based Compensation (Det_8
Stock-Based Compensation (Detail Textuals 2) | 12 Months Ended |
Sep. 30, 2018USD ($) | |
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 |
Unamortized expense | $ 1,552 |
Period for recognition of unamortized expense | 4 months 24 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] | |
Unamortized expense | $ 544,691 |
Period for recognition of unamortized expense | 11 months 12 days |
Collaboration Arrangements (Det
Collaboration Arrangements (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jul. 31, 2017 | Jun. 30, 2014 | Aug. 31, 2013 | May 31, 2013 | Sep. 30, 2018 | Sep. 30, 2017 | |
Huahai Agreement | ||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||
Revenue reorganization deferred revenue | $ 714,848 | $ 714,848 | ||||
Deferred revenue | 2,323,254 | 3,038,102 | ||||
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] | ||||||
Milestone payments received | 5,000,000 | |||||
Revenue reorganization deferred revenue | 261,072 | 261,072 | ||||
Deferred revenue | 848,486 | 1,109,558 | ||||
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 | 236,641 | ||||
Deferred revenue | 769,083 | 1,005,724 | ||||
Liomont agreement | Substantive milestones | ||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||
Milestone payments received | 2,000,000 | 3,000,000 | ||||
Liomont agreement | Non-substantive milestones | ||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||
Milestone payments received | $ 2,000,000 | |||||
BioLexis Agreement | ||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||
Milestone payments received | $ 1,250,000 | 2,500,000 | ||||
Revenue reorganization deferred revenue | 1,874,999 | 2,598,958 | ||||
Deferred revenue | $ 526,042 | 2,401,042 | ||||
Additional milestone payments received | $ 1,250,000 | $ 2,500,000 |
Related-Party Transactions (Det
Related-Party Transactions (Detail Textuals) - USD ($) | 1 Months Ended | 12 Months Ended | ||
May 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Nov. 30, 2017 | |
Related Party Transaction [Line Items] | ||||
Acquired additional laboratory and office equipment | $ 2,781,125 | $ 292,086 | ||
Sonnet Biotherapeutics, Inc. ("Sonnet") | ||||
Related Party Transaction [Line Items] | ||||
Estimated gross contract value if all milestones are met | $ 5,100,000 | |||
Laboratory equipment under capital leases | $ 115,000 | |||
Acquired additional laboratory and office equipment | $ 201,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | ||
State tax | $ (3,148,216) | $ 1,500 |
Foreign tax | (500,000) | 500,000 |
Income tax expense (benefit) | $ (3,648,216) | $ 501,500 |
Income Taxes (Details 1)
Income Taxes (Details 1) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal statutory rate | (24.30%) | (34.00%) |
State taxes, net of federal benefit | (6.90%) | (6.40%) |
Sale of New Jersey net operating losses | (7.10%) | 0.00% |
Net operating loss | 8.00% | 0.00% |
Change in tax rates | 66.60% | 0.00% |
Foreign withholding tax | (1.50%) | 1.30% |
Permanent differences | (0.60%) | (2.80%) |
Foreign tax credits | 1.50% | (1.60%) |
Research and development credit | (22.90%) | 0.00% |
Change in valuation allowance | (23.70%) | 44.80% |
Other | 0.10% | 0.00% |
Effective income tax rate | (10.80%) | 1.30% |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) | Sep. 30, 2018 | Sep. 30, 2017 |
Deferred tax assets | ||
Net operating loss carryforwards | $ 39,532,689 | $ 48,828,141 |
Stock-based compensation | 10,227,514 | 14,098,985 |
Deferred revenue | 1,264,069 | 3,017,238 |
Research and development credit carryforward | 8,491,452 | 757,701 |
Foreign tax credits | 2,357,309 | 2,857,309 |
Accruals and others | 605,173 | 1,539,943 |
Gross deferred tax assets | 62,478,206 | 71,099,317 |
Less: valuation allowance | (61,893,959) | (69,902,446) |
Deferred tax assets net of valuation allowance | 584,247 | 1,196,871 |
Deferred tax liability: | ||
Fixed assets | (584,247) | (1,196,871) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Details 3)
Income Taxes (Details 3) - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 2,352,129 | $ 1,854,629 |
Changes based on tax positions related to the current year | (496,000) | 497,500 |
Balance at end of year | $ 1,856,129 | $ 2,352,129 |
Income Taxes (Detail Textuals)
Income Taxes (Detail Textuals) - USD ($) | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credit carryforwards | $ 8,491,452 | $ 757,701 |
Foreign tax credit carryforwards | 2,357,309 | 2,857,309 |
Increase (decrease) in valuation allowance | (8,000,000) | 17,200,000 |
Recognition of income tax benefits | $ (3,648,216) | $ 501,500 |
Percentage of decrease in corporate tax rate | 21.00% | 34.00% |
U.S. federal statutory rate | (24.30%) | (34.00%) |
Decrease in deferred tax assets | $ (22,400,000) | |
New Jersey | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | 38,470,278 | |
Recognition of income tax benefits | 3,150,716 | |
New Jersey net operating loss | 68,100,000 | |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credit carryforwards | 6,600,000 | |
Foreign tax credit carryforwards | 2,400,000 | |
Federal net operating loss | 164,700,000 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Research and development tax credit carryforwards | 1,900,000 | |
Foreign | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | $ 400,000 |