Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Mar. 31, 2019 | May 13, 2019 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Outlook Therapeutics, Inc. | |
Entity Central Index Key | 0001649989 | |
Trading Symbol | ons | |
Current Fiscal Year End Date | --09-30 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 22,099,630 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true |
Consolidated Balance Sheets (un
Consolidated Balance Sheets (unaudited) - USD ($) | Mar. 31, 2019 | Sep. 30, 2018 |
Current assets: | ||
Cash | $ 155,468 | $ 1,717,391 |
Prepaid and other current assets | 1,974,664 | 1,585,089 |
Total current assets | 2,130,132 | 3,302,480 |
Property and equipment, net | 14,601,716 | 18,489,976 |
Other assets | 440,339 | 491,039 |
Total assets | 17,172,187 | 22,283,495 |
Current liabilities: | ||
Convertible senior secured notes | 7,617,419 | 13,179,449 |
Current portion of long-term debt | 1,052,714 | 66,480 |
Current portion of capital lease obligations | 217,949 | 520,794 |
Stockholder notes | 3,612,500 | 4,612,500 |
Accounts payable | 5,112,803 | 3,609,607 |
Accrued expenses | 5,187,301 | 6,458,471 |
Income taxes payable | 1,856,129 | 1,856,129 |
Deferred revenue | 2,335,392 | 1,738,603 |
Total current liabilities | 26,992,207 | 32,042,033 |
Long-term debt | 75,073 | 98,487 |
Capital lease obligations | 3,389,087 | 3,453,256 |
Warrant liability | 2,359,343 | 1,227,225 |
Deferred revenue | 4,116,993 | 2,758,262 |
Other liabilities | 3,286,451 | 3,514,738 |
Total liabilities | 40,219,154 | 43,094,001 |
Commitments (Note 9) | ||
Convertible preferred stock: | ||
Total convertible preferred stock | 5,039,195 | 4,734,416 |
Stockholders' equity (deficit): | ||
Preferred stock, value | ||
Common stock, par value $0.01 per share; 200,000,000 shares authorized; 11,759,630 shares issued and outstanding at March 31, 2019 and 9,027,491 shares issued and outstanding at September 30, 2018 | 117,596 | 90,275 |
Additional paid-in capital | 211,739,503 | 190,672,166 |
Accumulated deficit | (239,943,261) | (216,307,363) |
Total stockholders' equity (deficit) | (28,086,162) | (25,544,922) |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | 17,172,187 | 22,283,495 |
Series A convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | ||
Series A-1 convertible preferred stock | ||
Convertible preferred stock: | ||
Total convertible preferred stock | 5,039,195 | 4,734,416 |
Series B convertible preferred stock | ||
Stockholders' equity (deficit): | ||
Preferred stock, value |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (unaudited) (Parentheticals) - USD ($) | Mar. 31, 2019 | Sep. 30, 2018 |
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 7,300,000 | 7,300,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 11,759,630 | 9,027,491 |
Common stock, shares outstanding | 11,759,630 | 9,027,491 |
Series A convertible preferred stock | ||
Convertible preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Convertible preferred stock, shares issued | 0 | 0 |
Convertible preferred stock outstanding | 0 | 0 |
Series A-1 convertible preferred stock | ||
Convertible preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized | 200,000 | 200,000 |
Convertible preferred stock, shares issued | 63,250 | 60,203 |
Convertible preferred stock outstanding | 63,250 | 60,203 |
Series B convertible preferred stock | ||
Preferred stock, par value per share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations (unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||||
Collaboration revenues | $ 641,140 | $ 771,890 | $ 1,708,738 | $ 1,543,780 |
Operating expenses: | ||||
Research and development | 6,497,619 | 5,156,386 | 14,918,544 | 5,558,788 |
General and administrative | 1,849,158 | 2,446,505 | 4,753,146 | 5,995,757 |
Total operating expenses | 8,346,777 | 7,602,891 | 19,671,690 | 11,554,545 |
Loss from operations | (7,705,637) | (6,831,001) | (17,962,952) | (10,010,765) |
Interest expense, net | 1,053,877 | 920,870 | 2,174,726 | 1,638,753 |
Loss on extinguishment of debt | 183,554 | 183,554 | 1,252,353 | |
Change in fair value of warrant liability | 1,301,728 | (211,992) | (334,592) | (290,775) |
Loss before income taxes | (10,244,796) | (7,539,879) | (19,986,640) | (12,611,096) |
Income tax benefit | (3,150,716) | |||
Net loss | (10,244,796) | (7,539,879) | (19,986,640) | (9,460,380) |
Recognition of beneficial conversion feature upon issuance of Series A and A-1 convertible preferred stock | (61,365) | (381,664) | (61,365) | (15,736,683) |
Series A and A-1 convertible preferred stock dividends and related settlement | (154,271) | (636,695) | (304,779) | (1,087,496) |
Deemed dividend upon modification of warrants | (829,530) | (829,530) | ||
Net loss attributable to common stockholders | $ (11,289,962) | $ (8,558,238) | $ (21,182,314) | $ (26,284,559) |
Per share information: | ||||
Net loss per share of common stock, basic and diluted | $ (0.98) | $ (2.66) | $ (1.98) | $ (8.29) |
Weighted average shares outstanding, basic and diluted | 11,529,033 | 3,216,682 | 10,677,020 | 3,170,530 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (unaudited) - USD ($) | Convertible Preferred Stock Series A-1 | Convertible Preferred Stock Series A | Series B convertible preferred stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2017 | $ 2,924,441 | $ 31,167 | $ 152,533,260 | $ (186,215,402) | $ (33,650,975) | ||
Balance (in shares) at Sep. 30, 2017 | 32,628 | 3,116,743 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of vested restricted stock units | $ 1,009 | (1,009) | |||||
Issuance of vested restricted stock units (in shares) | 100,814 | ||||||
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 and A-1 convertible preferred stock dividends and related settlement | $ 1,104,480 | (1,087,496) | (1,087,496) | ||||
Series A and A-1 convertible preferred stock dividends and related settlement (in shares) | 11,045 | ||||||
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 | ||||||
Stock-based compensation expense | 1,589,609 | 1,589,609 | |||||
Net loss | (9,460,380) | (9,460,380) | |||||
Balance at Mar. 31, 2018 | $ 18,294,782 | $ 2,661,972 | $ 32,176 | 159,416,545 | (195,675,782) | (33,565,089) | |
Balance (in shares) at Mar. 31, 2018 | 261,045 | 1,500,000 | 3,217,557 | ||||
Balance at Dec. 31, 2017 | $ 17,190,302 | $ 2,661,972 | $ 31,913 | 160,353,714 | (188,135,903) | (25,088,304) | |
Balance (in shares) at Dec. 31, 2017 | 250,000 | 1,500,000 | 3,191,340 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of vested restricted stock units | $ 263 | (263) | |||||
Issuance of vested restricted stock units (in shares) | 26,217 | ||||||
Series A and A-1 convertible preferred stock dividends and related settlement | $ 1,104,480 | (636,695) | (636,695) | ||||
Series A and A-1 convertible preferred stock dividends and related settlement (in shares) | 11,045 | ||||||
Stock-based compensation expense | (300,211) | (300,211) | |||||
Net loss | (7,539,879) | (7,539,879) | |||||
Balance at Mar. 31, 2018 | $ 18,294,782 | $ 2,661,972 | $ 32,176 | 159,416,545 | (195,675,782) | (33,565,089) | |
Balance (in shares) at Mar. 31, 2018 | 261,045 | 1,500,000 | 3,217,557 | ||||
Balance at Sep. 30, 2018 | $ 4,734,416 | $ 90,275 | 190,672,166 | (216,307,363) | (25,544,922) | ||
Balance (in shares) at Sep. 30, 2018 | 60,203 | 9,027,491 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Cumulative effect of adoption of ASU 2014-09 (Topic 606) | (3,649,258) | (3,649,258) | |||||
Proceeds from exercise of common stock warrants | $ 9 | (9) | |||||
Proceeds from exercise of common stock warrants (in shares) | 909 | ||||||
Private placement sale of common stock, net of costs | $ 26,804 | 19,781,513 | 19,808,317 | ||||
Private placement sale of common stock, net of costs (in shares) | 2,680,390 | ||||||
Issuance of vested restricted stock units | $ 4 | (4) | |||||
Issuance of vested restricted stock units (in shares) | 446 | ||||||
Issuance of common stock in connection with conversion of senior secured notes | $ 504 | 401,464 | 401,968 | ||||
Issuance of common stock in connection with conversion of senior secured notes (in shares) | 50,394 | ||||||
Series A and A-1 convertible preferred stock dividends and related settlement | $ 304,779 | (304,779) | (304,779) | ||||
Series A and A-1 convertible preferred stock dividends and related settlement (in shares) | 3,047 | ||||||
Stock-based compensation expense | 1,189,152 | 1,189,152 | |||||
Net loss | (19,986,640) | (19,986,640) | |||||
Balance at Mar. 31, 2019 | $ 5,039,195 | $ 117,596 | 211,739,503 | (239,943,261) | (28,086,162) | ||
Balance (in shares) at Mar. 31, 2019 | 63,250 | 11,759,630 | |||||
Balance at Dec. 31, 2018 | $ 4,884,924 | $ 106,365 | 203,237,836 | (229,698,465) | (26,354,264) | ||
Balance (in shares) at Dec. 31, 2018 | 61,708 | 10,636,421 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Proceeds from exercise of common stock warrants | $ 3 | (3) | |||||
Proceeds from exercise of common stock warrants (in shares) | 358 | ||||||
Private placement sale of common stock, net of costs | $ 10,721 | 7,986,738 | 7,997,459 | ||||
Private placement sale of common stock, net of costs (in shares) | 1,072,156 | ||||||
Issuance of vested restricted stock units | $ 3 | (3) | |||||
Issuance of vested restricted stock units (in shares) | 301 | ||||||
Issuance of common stock in connection with conversion of senior secured notes | $ 504 | 401,464 | 401,968 | ||||
Issuance of common stock in connection with conversion of senior secured notes (in shares) | 50,394 | ||||||
Series A and A-1 convertible preferred stock dividends and related settlement | $ 154,271 | (154,271) | (154,271) | ||||
Series A and A-1 convertible preferred stock dividends and related settlement (in shares) | 1,542 | ||||||
Stock-based compensation expense | 267,742 | 267,742 | |||||
Net loss | (10,244,796) | (10,244,796) | |||||
Balance at Mar. 31, 2019 | $ 5,039,195 | $ 117,596 | $ 211,739,503 | $ (239,943,261) | $ (28,086,162) | ||
Balance (in shares) at Mar. 31, 2019 | 63,250 | 11,759,630 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) | 6 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
OPERATING ACTIVITIES | ||
Net loss | $ (19,986,640) | $ (9,460,380) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,639,618 | 1,407,888 |
Loss on extinguishment of debt | 183,554 | 1,252,353 |
Non-cash interest expense | 895,255 | 970,287 |
Stock-based compensation | 1,140,031 | 1,589,609 |
Change in fair value of warrant liability | (334,592) | (290,775) |
Loss on disposal of property and equipment | 2,911,138 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (88,514) | (262,503) |
Other assets | 42,527 | (56,401) |
Accounts payable | 233,569 | (6,909,512) |
Accrued expenses | (778,364) | (2,584,186) |
Deferred revenue | (1,693,738) | (1,543,780) |
Other liabilities | (221,287) | (222,627) |
Net cash used in operating activities | (16,057,443) | (16,110,027) |
INVESTING ACTIVITIES | ||
Purchase of property and equipment | (286,569) | (1,350,329) |
Net cash used in investing activities | (286,569) | (1,350,329) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of offering costs | 19,808,317 | |
Proceeds from issuance of Series A convertible preferred stock | 21,737,200 | |
Payments of capital leases obligations | (415,697) | (375,081) |
Repayment of debt | (4,627,180) | (62,009) |
Payment of financing costs | (1,089,158) | |
Net cash provided by financing activities | 14,765,440 | 20,210,952 |
Effect of foreign exchange rate on cash | 16,649 | |
Net (decrease) increase in cash | (1,561,923) | 2,750,596 |
Cash at beginning of period | 1,717,391 | 3,185,519 |
Cash at end of period | 155,468 | 5,936,115 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,681,746 | 25,505 |
Accrued interest settled by conversion into common stock | 1,393 | |
Supplemental schedule of noncash investing activities: | ||
Purchases of property and equipment in accounts payable and accrued expenses | 1,095,266 | 27,870 |
Supplemental schedule of noncash financing activities: | ||
Carrying amount of senior secured notes converted into common stock | 400,575 | |
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 in connection with purchase of property and equipment | 48,682 | 3,401,964 |
Change in fair value of convertible senior secured notes warrants recorded as debt discount | 1,466,710 | |
Series A and A-1 convertible preferred stock dividends and related settlement | 304,779 | $ 1,104,480 |
Accrued directors fees settled in fully vested stock options | $ 49,121 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Mar. 31, 2019 | |
Organization And Description Of Business [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Outlook Therapeutics, Inc., (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010 as Oncobiologics, Inc., started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. 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 | 6 Months Ended |
Mar. 31, 2019 | |
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 $239.9 million as of March 31, 2019. As of March 31, 2019, the Company had substantial indebtedness that included $8.5 million of senior secured notes that mature on June 30, 2019, $3.6 million unsecured notes that were due on demand as of such date, and $1.0 million of unsecured notes that were also due on demand as of such date but which are subject to a forbearance agreement through March 7, 2020. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. 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, of which approximately $0.8 million was received in April 2019. On April 12, 2019, the Company completed a public offering of 10,340,000 shares of its common stock, 15-month warrants to purchase up to an aggregate of 10,340,000 shares of common stock and five-year warrants to purchase up to an aggregate of 10,340,000 shares of common stock. The shares of common stock and the warrants were immediately separable and were issued separately. The warrants are exercisable immediately at an exercise price of $2.90 per share. The Company received approximately $26.2 million in net proceeds from the public offering after payment of fees, expenses and underwriting discounts and commissions. Management believes that the Company’s existing cash as of March 31, 2019, the $26.2 million of net proceeds from the April 2019 public common stock and warrants offering and anticipated proceeds from the sale of New Jersey NOLs and R&D credits will be sufficient to fund its operations into December 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: payments from potential strategic research and development partners, licensing and/or marketing arrangements with pharmaceutical companies, private placements of equity and/or debt securities, sale of its development stage product candidates to third parties and public offerings of equity and/or debt securities. There can be no assurance that these future funding efforts will be successful. The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to complete revenue-generating partnerships with pharmaceutical companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies, and, ultimately; (v) regulatory approval and market acceptance of the Company’s proposed future products. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2019 and its results of operations for the three and six months ended March 31, 2019 and 2018 and cash flows for the six months ended March 31, 2019 and 2018. Operating results for the three and six months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2019. The unaudited interim consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2018 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on December 18, 2018. Reverse stock-split On March 15, 2019, the Company amended its amended and restated certificate of incorporation to implement a one-for-eight reverse stock split of its common stock. As a result of the reverse stock split, the Company adjusted the share amounts under its employee incentive plans, outstanding options, restricted stock units and common stock warrant agreements with third parties. The disclosure of common shares and per common share data in the accompanying consolidated financial statements and related notes reflect the reverse stock split for all periods presented. Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Net loss per share Basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. The diluted loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended March 31, Six months ended March 31, 2019 2018 2019 2018 Net loss attributable to common stockholders $ (11,289,962 ) $ (8,558,238 ) $ (21,182,314 ) $ (26,284,559 ) Common stock outstanding (weighted average) 11,529,033 3,216,682 10,677,020 3,170,530 Basic and diluted net loss per share $ (0.98 ) $ (2.66 ) $ (1.98 ) $ (8.29 ) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of March 31, 2019 and 2018, as they would be antidilutive: As of March 31, 2019 2018 Series A convertible preferred stock - 4,933,221 Series A-1 convertible preferred stock 1,195,295 - Series B convertible preferred stock - 264,084 Convertible senior secured notes 957,482 - Convertible unsecured notes 147,347 - Performance-based stock units 16,131 20,491 Restricted stock units 7,156 12,221 Stock options 541,746 - Common stock warrants 5,660,949 3,514,563 Recently issued and adopted accounting pronouncements On October 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers · Contracts with customers · Significant judgments and changes in judgments · Certain assets The Company’s arrangements fall under ASC 808, Collaborations The Company adopted the new accounting standard utilizing the modified retrospective method, and, therefore, no adjustments were made to amounts in its prior period financial statements. The Company recorded the cumulative effect of adopting the standard as an adjustment to increase accumulated deficit by $3.6 million. For the three and six months ended March 31, 2019, the Company would have recognized $0.3 million and $1.1 million, respectively, of collaboration revenues under revenue recognition guidance in effect during fiscal 2018 prior to the adoption of ASU 2014-09. In February 2016, the FASB issued ASU No. 2016-02, Leases In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”) |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Mar. 31, 2019 | |
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: March 31, 2019 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ - $ - $ 2,359,343 September 30, 2018 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ - $ - $ 1,227,225 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 six months ended March 31, 2019: Balance at October 1, 2018 $ 1,227,225 Senior note warrants modification 1,466,710 (i) Change in fair value (334,592 ) Balance at March 31, 2019 $ 2,359,343 (i) In connection with the November 2018 BioLexis private placement (See Note 10), the Company reduced the exercise price of the warrants issued in connection with the senior secured notes (the “Senior Note Warrants”) from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. Such Senior Note Warrants now expire eight years from their initial exercise date. The Senior Note Warrants issued in connection with the senior secured notes (see Note 6) 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: March 31, September 30, 2019 2018 Risk-free interest rate 2.27 % 2.90 % Remaining contractual life of warrant 5.88 years 3.39 years Expected volatility 87 % 82 % Annual dividend yield 0 % 0 % Fair value of common stock $ 7.40 per share $ 7.84 per share |
Property and Equipment, Net
Property and Equipment, Net | 6 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net, consists of: March 31, September 30, 2019 2018 Laboratory equipment $ 14,075,953 $ 14,333,624 Leasehold improvements 10,118,564 10,095,100 Computer software and hardware 497,799 483,807 Land and building 3,000,000 3,000,000 Construction in progress 210,057 2,276,737 27,902,373 30,189,268 Less: accumulated depreciation and amortization (13,300,657 ) (11,699,292 ) $ 14,601,716 $ 18,489,976 Depreciation and amortization expense was $816,541 and $706,264 for the three months ended March 31, 2019 and 2018, respectively, and $1,639,618 and $1,407,888 for the six months ended March 31, 2019 and 2018, respectively. At March 31, 2019, $8,002,538 and 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. The Company’s corporate office lease matures in February 2028. 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%. At March 31, 2019 and September 30, 2018, $1,999,766 and $1,619,741, respectively, of accumulated amortization related to capital leases. The Company wrote off certain construction in progress and laboratory equipment with a carrying amount of $561,735 and $2,911,138 during the three and six months ended March 31, 2019, respectively, due to the Company changing its operations to focus solely on developing and commercializing ONS-5010. The charge was recorded to research and development on the consolidated statements of operations. The Company determined that the carrying amount of these assets was not recoverable and was less than the fair value less the cost to sell. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Mar. 31, 2019 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consists of: March 31, September 30, 2019 2018 Compensation $ 1,926,251 $ 2,231,122 Severance and related costs 135,432 396,138 Lease termination obligation 402,072 395,071 Research and development 1,155,042 1,065,169 Interest payable 1,093,384 1,991,044 Professional fees 332,085 313,585 Director fees - 59,122 Other accrued expenses 143,035 7,220 $ 5,187,301 $ 6,458,471 |
Senior Secured Notes
Senior Secured Notes | 6 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Senior Secured Notes | 7. Senior Secured Notes March 31, 2019 September 30, 2018 Convertible senior secured notes $ 8,460,171 $ 13,500,000 Unamortized debt discount (842,752 ) (320,551 ) $ 7,617,419 $ 13,179,449 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 “Exchanging Noteholders”), pursuant to which the Exchanging 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. In November 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 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 which the Company met in April 2019 through the completed public offering with gross proceeds of $28.4 million. In addition, the Company agreed to make the senior secured notes convertible into common stock at a price of $8.9539 per share (120% of the price per share paid by BioLexis under the November 2018 purchase agreement) and reduced the exercise price of warrants to purchase 485,245 shares of common stock held by the senior secured noteholders from $24.00 per share to $12.00 per share. The increase in the fair value of the warrants of $1.5 million due to the modification was recorded as additional debt discount. The Company repaid $4.6 million of principal and $1.3 million of accrued interest of such notes during the six months ended March 31, 2019. As of March 31, 2019, the senior secured notes remain classified as a current liability because they mature in less than 12 months. During February and March 2019, senior secured notes with a carrying amount of $400,575 and accrued interest of $1,393 were converted into an aggregate of 50,394 shares of the Company’s common stock. Interest expense on the senior secured notes for the three months ended March 31, 2019 and 2018 was $561,485 and $484,746, respectively, and $1,162,917 and $989,331 for the six months ended March 31, 2019 and 2018, respectively. |
Stockholder Notes
Stockholder Notes | 6 Months Ended |
Mar. 31, 2019 | |
Stockholder Notes [Abstract] | |
Stockholder Notes | 8. Stockholder Notes On March 7, 2019, the Company entered into a Forbearance and Exchange Agreement (the “Agreement”) with Iliad Research and Trading, L.P., a Utah limited partnership (the "Lender"). Concurrently with the execution of this Agreement, the Lender purchased two stockholder notes issued by the Company previously in the original principal amount of $1,000,000 with an aggregate outstanding balance as of March 7, 2019 of $1,947,133, including accrued interest. The stockholder notes were accruing interest at the rate of 2.5% per month. The Lender agreed to refrain and forbear from bringing any action to collect under the stockholder notes until March 7, 2020 and to reduce the interest rates currently in effect to 12% per annum simple interest during such forbearance period. The Company also agreed to, at the Lender's election, repay or exchange the stockholder notes (or portions thereof) for shares of the Company’s common stock at an exchange rate of $13.44 per share. The Agreement was accounted for as an extinguishment of debt and the Company recorded a loss of $183,554. |
Commitments
Commitments | 6 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 9. Commitments Leases 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 7th, 8th, 9th and a portion of the 10th monthly payments. The Company may pay the final $4.0 million payment at any time, whereupon the Company’s obligation to make the remaining monthly payments terminates. At March 31, 2019, the current portion of the lease termination obligation of $402,072 is included in accrued expenses and $3,207,046 is included in other liabilities on the consolidated balance sheets. A rollforward of the charges incurred to general and administrative expense for the six months ended March 31, 2019 is as follows: Balance Expensed / Cash Balance Lease termination payments $ 3,850,081 $ 9,037 $ (250,000 ) $ 3,609,118 |
Common Stock, Convertible Prefe
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) | 6 Months Ended |
Mar. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) | 10. Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) Common stock Pursuant to the November 5, 2018 BioLexis private placement, the Company closed the sale of this private placement for an aggregate of 2,680,390 shares of the Company’s common stock for gross cash proceeds of $20.0 million ($19.8 million net of issuance costs) during the six months ended March 31, 2019. During the six months ended March 31, 2019 and 2018, the Company issued 446 and 100,814 respectively, shares of common stock upon the vesting of RSUs. 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”) to acquire 2,093,750 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 4,724,493 shares of the Company’s common stock, representing an effective conversion rate of $5.28 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 $7.20 and $10.08 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 $7.20 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. In June 2018, BioLexis converted 208,836 shares of Series A Convertible into 3,946,577 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 A total of 200,000 shares of Series A-1 Convertible Preferred Stock (the “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 1,109,972 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 six months ended March 31, 2019, the Company issued 3,047 shares of Series A-1 Convertible to settle the related dividends that are due on a quarterly basis. 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 264,084 shares of common stock. The exchange was accounted for as an extinguishment of debt, See Note 7. During May and June 2018, the Noteholders converted all 1,500,000 shares of Series B Convertible into 264,084 shares of common stock. Accordingly, there are no longer any shares of Series B Convertible issued and outstanding. Common stock warrants As of March 31, 2019, shares of common stock issuable upon the exercise of outstanding warrants were as follows: Shares of common stock issuable upon exercise of warrants Exercise Price Per Share Expiration Date 416,666 $ 12.00 February 18, 2022 (i) 101,186 $ 0.08 November 11, 2019 277,122 $ 12.00 December 22, 2024 (ii) 145,686 $ 12.00 April 13, 2025 (ii) 62,437 $ 12.00 May 31, 2025 (ii) 2,093,750 $ 7.20 October 31, 2025 1,282,051 $ 7.80 May 10, 2026 1,282,051 $ 7.80 June 8, 2026 5,660,949 (i) In January 2019, the Company reduced the exercise price of these warrants from $52.80 to $12.00 and further extended the exercise period from February 18, 2019 to February 18, 2022. (ii) In November 2018, the Company reduced the exercise price of the warrants issued in connection with its senior secured notes from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. During the six months ended March 31, 2019, warrants to purchase 909 shares of common stock with an exercise price of $0.08 were exercised. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 11. Stock-Based Compensation 2011 Equity Incentive Plan The Company’s 2011 Equity Compensation Plan (the “2011 Plan”) provided for the Company to sell or issue restricted common stock, RSUs, performance-based awards (“PSUs”), 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 106,490. As of March 31, 2019, PSUs representing 16,131 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, (the “2015 Plan”) no future awards under the 2011 Plan will be granted. 2015 Equity Incentive Plan In December 2015, the Company adopted the 2015 Plan. The 2015 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The aggregate number of shares of common stock authorized for issuance pursuant to the Company’s 2015 Plan is 1,369,596. As of March 31, 2019, 654,338 shares remained available for grant under the 2015 Plan. Stock options and RSUs are granted under the Company’s 2015 Plan and generally vest over a period of two to four years from the date of grant and, in the case of stock options, have a term of 10 years. The Company recognizes the grant date fair value of each option and share of RSU over its vesting period. The Company recorded stock-based compensation expense in the following expense categories of its statements of operations for the three and six months ended March 31, 2019 and 2018: Three Months Ended March 31, Six Months Ended March 31, 2019 2018 2019 2018 Research and development $ 120,763 $ (403,034 ) $ 211,972 $ (84,793 ) General and administrative 146,979 102,823 928,059 1,674,402 $ 267,742 $ (300,211 ) $ 1,140,031 $ 1,589,609 During the six months ended March 31, 2019, the Company awarded stock options with a fair value of $49,121 as settlement for directors fees accrued as of September 30, 2018. Stock options As of March 31, 2019, options to purchase common stock of the Company outstanding under the 2015 Plan were as follows: Weighted Average Weighted Remaining Number of Average Contractual Shares Exercise Price Term (Years) Balance at October 1, 2018 182,120 $ 7.22 Granted 424,498 8.56 Expired (16,250 ) 7.59 Forfeited (48,622 ) 7.25 Balance at March 31, 2019 541,746 8.26 9.6 Vested and exercisable 131,789 7.22 9.5 Vested and expected to vest at March 31, 2019 541,746 $ 8.26 9.6 As of March 31, 2019, the aggregate intrinsic value of options outstanding was $102,984. 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 weighted average grant date fair value of the options awarded to employees for the six months ended March 31, 2019 and 2018 was $6.36 and $5.84 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: Six Months Ended March 31, 2019 2018 Risk-free interest rate 2.79 % 2.25 % Expected life (years) 5.87 5.93 Expected volatility 88.8 % 64.0 % Expected dividend yield - - As of March 31, 2019, there was $2,332,260 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 3.6 years. Performance-based stock units The Company has issued PSUs, which generally have a ten year life from the date of grant. 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 six months ended March 31, 2019: Weighted Average Number Base Remaining of Price Contractual PSUs Per PSU Term (Years) Balance at October 1, 2018 16,131 $ 49.99 Forfeitures - - Balance at March 31, 2019 16,131 49.99 5.3 Vested and exercisable at March 31, 2019 16,113 49.86 5.3 Vested and expected to vest at March 31, 2019 16,131 $ 49.99 5.3 Restricted stock units The following table summarizes the activity related to RSUs during the six months ended March 31, 2019: Weighted Number Average of Grant Date RSUs Fair Value Balance at October 1, 2018 7,638 $ 153.88 Vested and settled (446 ) 188.36 Forfeitures (36 ) 96.00 Balance at March 31, 2019 7,156 $ 152.03 As of March 31, 2019, there was $232,259 of unamortized expense that will be recognized over a weighted-average period of 0.57 years. |
Related-Party Transactions
Related-Party Transactions | 6 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 12. Related-Party Transactions MTTR — Strategic Partnership Agreement (ONS-5010) In November 2018, the (“MTTR”) In February 2018, the Company entered into a strategic partnership agreement with 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. MTTR earned an aggregate of $290,431 , which includes monthly consulting fees and expense reimbursement. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2019 and its results of operations for the three and six months ended March 31, 2019 and 2018 and cash flows for the six months ended March 31, 2019 and 2018. Operating results for the three and six months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2019. The unaudited interim consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2018 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on December 18, 2018. |
Reverse stock-split | Reverse stock-split On March 15, 2019, the Company amended its amended and restated certificate of incorporation to implement a one-for-eight reverse stock split of its common stock. As a result of the reverse stock split, the Company adjusted the share amounts under its employee incentive plans, outstanding options, restricted stock units and common stock warrant agreements with third parties. The disclosure of common shares and per common share data in the accompanying consolidated financial statements and related notes reflect the reverse stock split for all periods presented. |
Use of estimates | Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. |
Net loss per share | Net loss per share Basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. The diluted loss per common share calculation is further affected by an add-back of change in fair value of warrant liability to the numerator under the assumption that the change in fair value of warrant liability would not have been incurred if the warrants had been converted into common stock. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended March 31, Six months ended March 31, 2019 2018 2019 2018 Net loss attributable to common stockholders $ (11,289,962 ) $ (8,558,238 ) $ (21,182,314 ) $ (26,284,559 ) Common stock outstanding (weighted average) 11,529,033 3,216,682 10,677,020 3,170,530 Basic and diluted net loss per share $ (0.98 ) $ (2.66 ) $ (1.98 ) $ (8.29 ) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of March 31, 2019 and 2018, as they would be antidilutive: As of March 31, 2019 2018 Series A convertible preferred stock - 4,933,221 Series A-1 convertible preferred stock 1,195,295 - Series B convertible preferred stock - 264,084 Convertible senior secured notes 957,482 - Performance-based stock units 16,131 20,491 Restricted stock units 7,155 12,221 Stock options 541,746 - Common stock warrants 5,660,949 3,514,563 |
Recently issued and adopted accounting pronouncements | Recently issued and adopted accounting pronouncements On October 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers · Contracts with customers · Significant judgments and changes in judgments · Certain assets The Company’s arrangements fall under ASC 808, Collaborations The Company adopted the new accounting standard utilizing the modified retrospective method, and, therefore, no adjustments were made to amounts in its prior period financial statements. The Company recorded the cumulative effect of adopting the standard as an adjustment to increase accumulated deficit by $3.6 million. For the three and six months ended March 31, 2019, the Company would have recognized $0.3 million and $1.1 million, respectively, of collaboration revenues under revenue recognition guidance in effect during fiscal 2018 prior to the adoption of ASU 2014-09. In February 2016, the FASB issued ASU No. 2016-02, Leases In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”) |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of computation of basic earnings per share and diluted earnings per share | Three months ended March 31, Six months ended March 31, 2019 2018 2019 2018 Net loss attributable to common stockholders $ (11,289,962 ) $ (8,558,238 ) $ (21,182,314 ) $ (26,284,559 ) Common stock outstanding (weighted average) 11,529,033 3,216,682 10,677,020 3,170,530 Basic and diluted net loss per share $ (0.98 ) $ (2.66 ) $ (1.98 ) $ (8.29 ) |
Schedule of dilutive securities excluded from the computation weighted-average shares | As of March 31, 2019 2018 Series A convertible preferred stock - 4,933,221 Series A-1 convertible preferred stock 1,195,295 - Series B convertible preferred stock - 264,084 Convertible senior secured notes 957,482 - Convertible unsecured notes 147,347 - Performance-based stock units 16,131 20,491 Restricted stock units 7,156 12,221 Stock options 541,746 - Common stock warrants 5,660,949 3,514,563 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | March 31, 2019 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ - $ - $ 2,359,343 September 30, 2018 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ - $ - $ 1,227,225 |
Schedule of changes in the fair value of Level 3 valuation for the warrant liability | Balance at October 1, 2018 $ 1,227,225 Senior note warrants modification 1,466,710 (i) Change in fair value (334,592 ) Balance at March 31, 2019 $ 2,359,343 (i) In connection with the November 2018 BioLexis private placement (See Note 10), the Company reduced the exercise price of the warrants issued in connection with the senior secured notes (the “Senior Note Warrants”) from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. Such Senior Note Warrants now expire eight years from their initial exercise date. |
Schedule of fair value of the warrant liability | March 31, September 30, 2019 2018 Risk-free interest rate 2.27 % 2.90 % Remaining contractual life of warrant 5.88 years 3.39 years Expected volatility 87 % 82 % Annual dividend yield 0 % 0 % Fair value of common stock $ 7.40 per share $ 7.84 per share |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | March 31, September 30, 2019 2018 Laboratory equipment $ 14,075,953 $ 14,333,624 Leasehold improvements 10,118,564 10,095,100 Computer software and hardware 497,799 483,807 Land and building 3,000,000 3,000,000 Construction in progress 210,057 2,276,737 27,902,373 30,189,268 Less: accumulated depreciation and amortization (13,300,657 ) (11,699,292 ) $ 14,601,716 $ 18,489,976 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Accrued Expenses [Abstract] | |
Schedule of accrued expenses | March 31, September 30, 2019 2018 Compensation $ 1,926,251 $ 2,231,122 Severance and related costs 135,432 396,138 Lease termination obligation 402,072 395,071 Research and development 1,155,042 1,065,169 Interest payable 1,093,384 1,991,044 Professional fees 332,085 313,585 Director fees - 59,122 Other accrued expenses 143,035 7,220 $ 5,187,301 $ 6,458,471 |
Senior Secured Notes (Tables)
Senior Secured Notes (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of senior secured note | March 31, 2019 September 30, 2018 Convertible senior secured notes $ 8,460,171 $ 13,500,000 Unamortized debt discount (842,752 ) (320,551 ) $ 7,617,419 $ 13,179,449 |
Commitments (Tables)
Commitments (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments in operating leases | Balance Expensed / Cash Balance Lease termination payments $ 3,850,081 $ 9,037 $ (250,000 ) $ 3,609,118 |
Common Stock, Convertible Pre_2
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Schedule of warrants outstanding | Shares of common stock issuable upon exercise of warrants Exercise Price Per Share Expiration Date 416,666 $ 12.00 February 18, 2022 (i) 101,186 $ 0.08 November 11, 2019 277,122 $ 12.00 December 22, 2024 (ii) 145,686 $ 12.00 April 13, 2025 (ii) 62,437 $ 12.00 May 31, 2025 (ii) 2,093,750 $ 7.20 October 31, 2025 1,282,051 $ 7.80 May 10, 2026 1,282,051 $ 7.80 June 8, 2026 5,660,949 (i) In January 2019, the Company reduced the exercise price of these warrants from $52.80 to $12.00 and further extended the exercise period from February 18, 2019 to February 18, 2022. (ii) In November 2018, the Company reduced the exercise price of the warrants issued in connection with its senior secured notes from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of stock-based compensation expense | Three Months Ended March 31, Six Months Ended March 31, 2019 2018 2019 2018 Research and development $ 120,763 $ (403,034 ) $ 211,972 $ (84,793 ) General and administrative 146,979 102,823 928,059 1,674,402 $ 267,742 $ (300,211 ) $ 1,140,031 $ 1,589,609 |
Schedule of options to purchase common stock of Company outstanding under 2015 Plan | Weighted Average Weighted Remaining Number of Average Contractual Shares Exercise Price Term (Years) Balance at October 1, 2018 182,120 $ 7.22 Granted 424,498 8.56 Expired (16,250 ) 7.59 Forfeited (48,622 ) 7.25 Balance at March 31, 2019 541,746 8.26 9.6 Vested and exercisable 131,789 7.22 9.5 Vested and expected to vest at March 31, 2019 541,746 $ 8.26 9.6 |
Schedule of assumptions under fair value of options estimated on the date of grant using a Black-Scholes option pricing model | Six Months Ended March 31, 2019 2018 Risk-free interest rate 2.79 % 2.25 % Expected life (years) 5.87 5.93 Expected volatility 88.8 % 64.0 % Expected dividend yield - - |
Schedule of performance-based stock units activity | Weighted Average Number Base Remaining of Price Contractual PSUs Per PSU Term (Years) Balance at October 1, 2018 16,131 $ 49.99 Forfeitures - - Balance at March 31, 2019 16,131 49.99 5.3 Vested and exercisable at March 31, 2019 16,113 49.86 5.3 Vested and expected to vest at March 31, 2019 16,131 $ 49.99 5.3 |
Schedule of restricted stock units activity | Weighted Number Average of Grant Date RSUs Fair Value Balance at October 1, 2018 7,638 $ 153.88 Vested and settled (446 ) 188.36 Forfeitures (36 ) 96.00 Balance at March 31, 2019 7,156 $ 152.03 |
Liquidity (Detail Textuals)
Liquidity (Detail Textuals) - USD ($) | Apr. 12, 2019 | Apr. 30, 2019 | Nov. 30, 2018 | Mar. 31, 2019 | Sep. 30, 2018 |
Liquidity [Line Items] | |||||
Accumulated deficit | $ (239,943,261) | $ (216,307,363) | |||
Secured notes | 8,500,000 | ||||
Unsecured notes | $ 3,600,000 | ||||
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 | ||||
Proceeds received from net operating losses and research and development tax credits | $ 800,000 | ||||
Number of common stock called by warrants | 5,660,949 | ||||
Forbearance agreement | |||||
Liquidity [Line Items] | |||||
Unsecured notes | $ 1,000,000 | ||||
Subsequent Event | |||||
Liquidity [Line Items] | |||||
Exercise price of warrants | $ 2.90 | ||||
Subsequent Event | IPO | |||||
Liquidity [Line Items] | |||||
Number of common stock issued under public offering | 10,340,000 | ||||
Net proceeds from public stock offering | $ 26,200,000 | $ 26,200,000 | |||
15-month warrants | Subsequent Event | |||||
Liquidity [Line Items] | |||||
Number of common stock called by warrants | 10,340,000 | ||||
Five-year warrants | Subsequent Event | |||||
Liquidity [Line Items] | |||||
Number of common stock called by warrants | 10,340,000 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Basic and diluted earnings per share: | ||||
Net loss attributable to common stockholders | $ (11,289,962) | $ (8,558,238) | $ (21,182,314) | $ (26,284,559) |
Common stock outstanding (weighted average) | 11,529,033 | 3,216,682 | 10,677,020 | 3,170,530 |
Basic and diluted net loss per share (in dollars per share) | $ (0.98) | $ (2.66) | $ (1.98) | $ (8.29) |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies (Details 1) - shares | 6 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Series A convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 0 | 4,933,221 |
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 | 1,195,295 | 0 |
Series B convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 0 | 264,084 |
Convertible senior secured notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 957,482 | 0 |
Convertible unsecured notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 147,347 | 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 | 16,131 | 20,491 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 7,156 | 12,221 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 541,746 | 0 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 5,660,949 | 3,514,563 |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies (Detail Textuals) $ in Millions | 3 Months Ended | 6 Months Ended |
Mar. 31, 2019USD ($) | Mar. 31, 2019USD ($) | |
Accounting Policies [Abstract] | ||
Adjustment to increase to accumulated deficit | $ 3.6 | $ 3.6 |
Collaboration revenues under revenue recognition guidance | $ 0.3 | $ 1.1 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Mar. 31, 2019 | Sep. 30, 2018 |
Liabilities | ||
Warrant liability | $ 2,359,343 | $ 1,227,225 |
Fair value measurements recurring basis | Level 1 | ||
Liabilities | ||
Warrant liability | 0 | 0 |
Fair value measurements recurring basis | Level 2 | ||
Liabilities | ||
Warrant liability | 0 | 0 |
Fair value measurements recurring basis | Level 3 | ||
Liabilities | ||
Warrant liability | $ 2,359,343 | $ 1,227,225 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details 1) - Warrant | 6 Months Ended | |
Mar. 31, 2019USD ($) | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance at October 1, 2018 | $ 1,227,225 | |
Senior note warrants modification | 1,466,710 | [1] |
Change in fair value | (334,592) | |
Balance at March 31, 2019 | $ 2,359,343 | |
[1] | In connection with the November 2018 BioLexis private placement (See Note 10), the Company reduced the exercise price of the warrants issued in connection with the senior secured notes (the “Senior Note Warrants”) from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. Such Senior Note Warrants now expire eight years from their initial exercise date. |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details 2) | Mar. 31, 2019Price_Per_Share | Sep. 30, 2018Price_Per_Share |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 2.27 | 2.90 |
Remaining contractual life of warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term | 5 years 10 months 17 days | 3 years 4 months 21 days |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 87 | 82 |
Annual dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 0 | 0 |
Fair value of common stock | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 7.40 | 7.84 |
Fair Value Measurements (Deta_4
Fair Value Measurements (Detail Textuals) - Private Placement - BioLexis - Senior Note Warrants | 1 Months Ended |
Nov. 30, 2018$ / shares | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Exercise price per share | $ 24 |
Reduced exercise price of warrants | $ 12 |
Extended expiration term of senior note warrants | 3 years |
Terms of warrant expiration | 8 years |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) | Mar. 31, 2019 | Sep. 30, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 27,902,373 | $ 30,189,268 |
Less: accumulated depreciation and amortization | (13,300,657) | (11,699,292) |
Property and equipment, net | 14,601,716 | 18,489,976 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 14,075,953 | 14,333,624 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 10,118,564 | 10,095,100 |
Computer software and hardware | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 497,799 | 483,807 |
Land and building | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,000,000 | 3,000,000 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 210,057 | $ 2,276,737 |
Property and Equipment, Net (_2
Property and Equipment, Net (Detail Textuals) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Sep. 30, 2018 | |
Property, Plant and Equipment [Line Items] | |||||
Depreciation and amortization expense | $ 816,541 | $ 706,264 | $ 1,639,618 | $ 1,407,888 | |
Corporate office, interest rate | 43.90% | ||||
Accumulated amortization related to capital leases | 1,999,766 | $ 1,999,766 | $ 1,619,741 | ||
Carrying amount of equipment written off | (2,911,138) | ||||
Laboratory Equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Laboratory equipment under capital leases | 8,002,538 | $ 8,002,538 | $ 7,953,856 | ||
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% | ||||
Construction in progress and laboratory equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Carrying amount of equipment written off | $ 561,735 | $ 2,911,138 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2019 | Sep. 30, 2018 |
Accrued Liabilities, Current [Abstract] | ||
Compensation | $ 1,926,251 | $ 2,231,122 |
Severance and related costs | 135,432 | 396,138 |
Lease termination obligation | 402,072 | 395,071 |
Research and development | 1,155,042 | 1,065,169 |
Interest payable | 1,093,384 | 1,991,044 |
Professional fees | 332,085 | 313,585 |
Director fees | 0 | 59,122 |
Other accrued expenses | 143,035 | 7,220 |
Accrued expenses, total | $ 5,187,301 | $ 6,458,471 |
Senior Secured Notes (Details)
Senior Secured Notes (Details) - USD ($) | Mar. 31, 2019 | Sep. 30, 2018 |
Debt Instrument [Line Items] | ||
Senior secured notes | $ 7,617,419 | $ 13,179,449 |
Senior secured notes (the "Noteholders") | ||
Debt Instrument [Line Items] | ||
Convertible senior secured notes | 8,460,171 | 13,500,000 |
Unamortized debt discount | (842,752) | (320,551) |
Senior secured notes | $ 7,617,419 | $ 13,179,449 |
Senior Secured Notes (Detail Te
Senior Secured Notes (Detail Textuals) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Nov. 30, 2018USD ($)$ / sharesshares | Oct. 31, 2017USD ($)Investorshares | Mar. 31, 2019USD ($)$ / sharesshares | Mar. 31, 2018USD ($) | Mar. 31, 2019USD ($)$ / sharesshares | Mar. 31, 2018USD ($) | |
Debt Instrument [Line Items] | ||||||
Loss on extinguishment of debt | $ (183,554) | $ (183,554) | $ (1,252,353) | |||
Number of common stock called by warrants | shares | 5,660,949 | 5,660,949 | ||||
Series B convertible preferred stock ("Series B Convertible") | ||||||
Debt Instrument [Line Items] | ||||||
Number of common stock called by warrants | shares | 909 | 909 | ||||
Exercise price per share | $ / shares | $ 0.08 | $ 0.08 | ||||
Accrued interest | $ 41,507 | |||||
Senior secured notes (the "Noteholders") | ||||||
Debt Instrument [Line Items] | ||||||
Aggregate principal amount of senior secured notes | $ 400,575 | |||||
Number of preferred shares issued upon conversion of debt | shares | 50,394 | |||||
Repayment of principal amount | $ 4,600,000 | |||||
Repayments of accrued interest | 1,300,000 | |||||
Accrued interest | $ 1,393 | 1,393 | ||||
Interest expense | $ 561,485 | $ 484,746 | $ 1,162,917 | $ 989,331 | ||
Purchase and exchange agreement (the "Exchange Agreement") | Series B convertible preferred stock ("Series B Convertible") | ||||||
Debt Instrument [Line Items] | ||||||
Number of preferred shares issued upon conversion of debt | shares | 1,500,000 | |||||
Purchase and exchange agreement (the "Exchange Agreement") | Senior secured notes (the "Noteholders") | ||||||
Debt Instrument [Line Items] | ||||||
Number of existing investors and holders | Investor | 2 | |||||
Aggregate principal amount of senior secured notes | $ 1,500,000 | |||||
Accrued interest on debt conversion | 41,507 | |||||
Loss on extinguishment of debt | $ 1,252,353 | |||||
Senior secured notes, principal amount | $ 13,500,000 | |||||
Proceeds from issuance initial public offering | $ 28,400,000 | |||||
Common stock price per share | $ / shares | $ 8.9539 | |||||
Number of common stock called by warrants | shares | 485,245 | |||||
Additional debt discount | $ 1,500,000 | |||||
Purchase and exchange agreement (the "Exchange Agreement") | Senior secured notes (the "Noteholders") | BioLexis | Common Stock | ||||||
Debt Instrument [Line Items] | ||||||
Percentage of price per share paid | 120.00% | |||||
Private Placement | Senior secured notes (the "Noteholders") | BioLexis | ||||||
Debt Instrument [Line Items] | ||||||
Exercise price per share | $ / shares | $ 24 | |||||
Reduced exercise price of the warrants | $ / shares | $ 12 |
Stockholder Notes (Detail Textu
Stockholder Notes (Detail Textuals) - USD ($) | Mar. 07, 2019 | Mar. 31, 2019 | Sep. 30, 2018 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Common stock price per share | $ 0.01 | $ 0.01 | |
Forbearance and exchange agreement | Iliad Research and Trading, L.P., | Stockholder note | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Original principal amount | $ 1,000,000 | ||
Outstanding balance including accrued interest | $ 1,947,133 | ||
Rate of accruing interest per month | 2.50% | ||
Interest rate | 12.00% | ||
Common stock price per share | $ 13.44 | ||
Loss on extinguishment of debt | $ 183,554 |
Commitments (Details)
Commitments (Details) | 6 Months Ended |
Mar. 31, 2019USD ($) | |
Lease Termination Obligation [Roll Forward] | |
Lease termination payments, Balance October 1, 2018 | $ 3,850,081 |
Expensed /accrued expense | 9,037 |
Cash payments | (250,000) |
Lease termination payments, Balance March 31, 2019 | $ 3,609,118 |
Commitments (Detail Textuals)
Commitments (Detail Textuals) - USD ($) | 1 Months Ended | ||
Aug. 31, 2018 | Mar. 31, 2019 | Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |||
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 | ||
Date of payment | Feb. 1, 2021 | ||
Security deposit | $ 174,250 | ||
Final payment of lease obligation | $ 4,000,000 | ||
Lease termination obligation | $ 402,072 | $ 395,071 | |
Accrued liabilities and other liabilities | $ 3,207,046 |
Common Stock, Convertible Pre_3
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Details) | 6 Months Ended | |
Mar. 31, 2019$ / sharesshares | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 5,660,949 | |
Series A warrants | February 18, 2022 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 416,666 | [1] |
Exercise Price Per Share | $ / shares | $ 12 | [1] |
Expiration Date | Feb. 18, 2022 | [1] |
Common stock warrants issued with initial public offering | November 11, 2019 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 101,186 | |
Exercise Price Per Share | $ / shares | $ 0.08 | |
Expiration Date | Nov. 11, 2019 | |
Senior note warrants issued with senior secured notes | December 22, 2024 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 277,122 | [2] |
Exercise Price Per Share | $ / shares | $ 12 | [2] |
Expiration Date | Dec. 22, 2024 | [2] |
Senior note warrants issued with senior secured notes | April 13, 2025 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 145,686 | |
Exercise Price Per Share | $ / shares | $ 12 | [2] |
Expiration Date | Apr. 13, 2025 | [2] |
Senior note warrants issued with senior secured notes | May 31, 2025 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 62,437 | [2] |
Exercise Price Per Share | $ / shares | $ 12 | [2] |
Expiration Date | May 31, 2025 | [2] |
Common stock warrants issued with Series A preferred | October 31, 2025 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 2,093,750 | |
Exercise Price Per Share | $ / shares | $ 7.20 | |
Expiration Date | Oct. 31, 2025 | |
Common stock warrants issued in May 2018 | May 10, 2026 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 1,282,051 | |
Exercise Price Per Share | $ / shares | $ 7.80 | |
Expiration Date | May 10, 2026 | |
Common stock warrants issued in June 2018 | June 8, 2026 | ||
Class of Warrant or Right [Line Items] | ||
Shares of common stock issuable upon exercise of warrants | 1,282,051 | |
Exercise Price Per Share | $ / shares | $ 7.80 | |
Expiration Date | Jun. 8, 2026 | |
[1] | In January 2019, the Company reduced the exercise price of these warrants from $52.80 to $12.00 and further extended the exercise period from February 18, 2019 to February 18, 2022. | |
[2] | In November 2018, the Company reduced the exercise price of the warrants issued in connection with its senior secured notes from $24.00 to $12.00 and extended the expiration of the Senior Note Warrants by three years. |
Common Stock, Convertible Pre_4
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parentheticals) (Details) - $ / shares | 1 Months Ended | |
Jan. 31, 2019 | Nov. 30, 2018 | |
Series A warrants | ||
Class of Warrant or Right [Line Items] | ||
Exercise price of warrants issued for common stock | $ 52.80 | |
Reduced exercise price of the warrants | $ 12 | |
Senior note warrants issued with senior secured notes | ||
Class of Warrant or Right [Line Items] | ||
Exercise price of warrants issued for common stock | $ 24 | |
Reduced exercise price of the warrants | $ 12 | |
Term of warrant | 3 years |
Common Stock, Convertible Pre_5
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Detail Textuals) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2018 | Oct. 31, 2017 | Sep. 30, 2017 | Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | Sep. 07, 2017 | |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Proceeds from issuance of private placement | $ 800,000 | |||||||
Value of shares issued in cash | $ 6,382,181 | |||||||
Number of common stock called by warrants | 5,660,949 | 5,660,949 | ||||||
Series A convertible preferred stock | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Value of shares issued in cash | $ 14,265,861 | |||||||
Number of share issued | 217,372 | |||||||
Common Stock | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Issuance of vested restricted stock units (in shares) | 301 | 26,217 | 446 | 100,814 | ||||
BioLexis | Series A convertible preferred stock | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Number of Series A convertible stock converted | 208,836 | |||||||
Number of common stock issued upon conversion | 3,946,577 | |||||||
Purchase Agreement | BioLexis | Common Stock | Series A convertible preferred stock | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Convertible preferred stock, shares issued upon conversion | 4,724,493 | 4,724,493 | ||||||
Conversion rate per share | $ 5.28 | $ 5.28 | ||||||
IPO | Purchase Agreement | BioLexis | Series A convertible preferred stock | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Number of share issued | 32,628 | |||||||
Proceeds from issuance of Series A convertible preferred stock | $ 3,262,800 | |||||||
Dividend rate | 10.00% | |||||||
Private Placement | Purchase Agreement | BioLexis | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Sale of stock, number of shares issued in transaction (in shares) | 2,680,390 | |||||||
Proceeds from issuance of private placement | $ 20,000,000 | |||||||
Proceeds from issuance of private placement (net of issuance costs) | $ 19,800,000 | |||||||
Private Placement | Purchase Agreement | BioLexis | Series A Convertible Preferred Stock and BioLexis Warrants | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Sale of stock, number of shares issued in transaction (in shares) | 217,372 | |||||||
Cash received upon sale of Series A Convertible and GMS Tenshi Warrants | $ 21,737,200 | |||||||
Value of shares issued in cash | $ 25,000,000 | |||||||
Number of common stock called by warrants | 2,093,750 | |||||||
Term of warrant | 8 years | |||||||
Exercise price of warrants | $ 7.20 | |||||||
Convertible preferred stock, beneficial conversion charge | $ 15,355,019 | |||||||
Private Placement | Purchase Agreement | BioLexis | Series A convertible preferred stock | ||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | ||||||||
Closing price of common stock | $ 10.08 | $ 7.20 |
Common Stock, Convertible Pre_6
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Detail Textuals 1) - $ / shares | 6 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Sep. 30, 2018 | |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||
Preferred stock, stated value (in dollars per share) | $ 0.01 | $ 0.01 | |
Series A convertible preferred stock | |||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||
Number of share issued | 217,372 | ||
BioLexis | Series A convertible preferred stock | |||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||
Number of stock issued for settle of dividend | 3,047 | ||
Purchase and exchange agreement (the "Exchange Agreement") | BioLexis | Series A-1 convertible preferred stock | |||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||
Series A-1 authorized for issuance | 200,000 | ||
Preferred stock, stated value (in dollars per share) | $ 100 | ||
Convertible preferred stock, shares issued upon conversion | 1,109,972 | ||
Dividend rate | 10.00% | ||
Liquidation preference description | 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%. | ||
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. |
Common Stock, Convertible Pre_7
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Detail Textuals 2) - USD ($) | 1 Months Ended | ||
Jun. 30, 2018 | Oct. 31, 2017 | Mar. 31, 2019 | |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||
Number of warrants issued | 5,660,949 | ||
Series B convertible preferred stock | |||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||
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 converted | 1,500,000 | ||
Number of stock issued upon conversion | 264,084 | 264,084 | |
Number of warrants issued | 909 | ||
Exercise price per share | $ 0.08 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - 2015 Equity Incentive Plan - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 267,742 | $ (300,211) | $ 1,140,031 | $ 1,589,609 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 120,763 | (403,034) | 211,972 | (84,793) |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 146,979 | $ 102,823 | $ 928,059 | $ 1,674,402 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details 1) | 6 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Number of Shares | |
Balance at October 1, 2018 | shares | 182,120 |
Granted | shares | 424,498 |
Expired | shares | (16,250) |
Forfeited | shares | (48,622) |
Balance at March 31, 2019 | shares | 541,746 |
Vested and exercisable | shares | 131,789 |
Vested and expected to vest at March 31, 2019 | shares | 541,746 |
Weighted Average Exercise Price | |
Balance at October 1, 2018 | $ / shares | $ 7.22 |
Granted | $ / shares | 8.56 |
Expired | $ / shares | 7.59 |
Forfeited | $ / shares | 7.25 |
Balance at March 31, 2019 | $ / shares | 8.26 |
Vested and exercisable | $ / shares | 7.22 |
Vested and expected to vest at March 31, 2019 | $ / shares | $ 8.26 |
Weighted Average Remaining Contractual Term (Years) | |
Balance at December 31, 2018 | 9 years 7 months 6 days |
Vested and exercisable | 9 years 6 months |
Vested and expected to vest at March 31, 2019 | 9 years 7 months 6 days |
Stock-Based Compensation (Det_3
Stock-Based Compensation (Details 2) | 6 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Risk-free interest rate | 2.79% | 2.25% |
Expected life (years) | 5 years 10 months 13 days | 5 years 11 months 5 days |
Expected volatility | 88.80% | 64.00% |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation (Det_4
Stock-Based Compensation (Details 3) - Performance-based stock units | 6 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Number of PSUs | |
Balance at October 1, 2018 | shares | 16,131 |
Forfeitures | shares | 0 |
Balance at March 31, 2019 | shares | 16,131 |
Vested and exercisable at March 31, 2019 | shares | 16,113 |
Vested and expected to vest at March 31, 2019 | shares | 16,131 |
Base Price Per PSU | |
Balance at October 1, 2018 | $ / shares | $ 49.99 |
Forfeitures | $ / shares | 0 |
Balance at March 31, 2019 | $ / shares | 49.99 |
Vested and exercisable at March 31, 2019 | $ / shares | 49.86 |
Vested and expected to vest at March 31, 2019 | $ / shares | $ 49.99 |
Weighted Average Remaining Contractual Term (Years) | |
Balance at March 31, 2019 | 5 years 3 months 18 days |
Vested and exercisable at March 31, 2019 | 5 years 3 months 18 days |
Vested and expected to vest at March 31, 2019 | 5 years 3 months 18 days |
Stock-Based Compensation (Det_5
Stock-Based Compensation (Details 4) - Restricted stock units | 6 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Number of RSUs | |
Balance at October 1, 2018 | shares | 7,638 |
Vested and settled | shares | (446) |
Forfeitures | shares | (36) |
Balance at March 31, 2019 | shares | 7,156 |
Weighted Average Grant Date Fair Value | |
Balance at October 1, 2018 | $ / shares | $ 153.88 |
Vested and settled | $ / shares | 188.36 |
Forfeitures | $ / shares | 96 |
Balance at March 31, 2019 | $ / shares | $ 152.03 |
Stock-Based Compensation (Det_6
Stock-Based Compensation (Detail Textuals) - USD ($) | 6 Months Ended | |
Mar. 31, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock, shares outstanding | 11,759,630 | 9,027,491 |
Accrued directors fees settled in fully vested stock options | $ 49,121 | |
2015 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate number of common stock authorized for issuance | 1,369,596 | |
Number of shares available for grant | 654,338 | |
Vesting period | 10 years | |
2015 Equity Incentive Plan | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 2 years | |
2015 Equity Incentive Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | |
2011 Equity Compensation Plan (the "2011 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 | 106,490 | |
Aggregate number of common stock authorized for issuance | 16,131 |
Stock-Based Compensation (Det_7
Stock-Based Compensation (Detail Textuals 1) - Stock options - USD ($) | 6 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate intrinsic value | $ 102,984 | |
Weighted average grant date fair value of the options awarded to employees | $ 6.36 | $ 5.84 |
Unrecognized compensation expense | $ 2,332,260 | |
Weighted average period of unrecognized compensation expense that is expected to be recognized | 3 years 7 months 6 days |
Stock-Based Compensation (Det_8
Stock-Based Compensation (Detail Textuals 2) - USD ($) | 6 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Performance-based stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term of PSUs | 10 years | |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unamortized expense to be recognized of stock awards other than options | $ 232,259 | |
Weighted-average period for recognition of unamortized expense | 6 months 26 days |
Related-Party Transactions (Det
Related-Party Transactions (Detail Textuals) - Strategic partnership agreement - MTTR, LLC - USD ($) | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2019 | Nov. 30, 2018 | |
Related Party Transaction [Line Items] | |||
Revenue from consulting fees and expense reimbursement | $ 290,431 | $ 580,911 | |
Terry Dagnon | |||
Related Party Transaction [Line Items] | |||
Percentage of ownership interest | 16.66% |