Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Jun. 30, 2020 | Aug. 12, 2020 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2020 | |
Entity Registrant Name | Outlook Therapeutics, Inc. | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 127,183,109 | |
Entity Central Index Key | 0001649989 | |
Current Fiscal Year End Date | --09-30 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2020 | Sep. 30, 2019 |
Current assets: | ||
Cash | $ 23,953,080 | $ 8,015,528 |
Prepaid expenses and other current assets | 4,282,298 | 4,986,033 |
Assets held for sale | 500,000 | |
Total current assets | 28,235,378 | 13,501,561 |
Property and equipment, net | 368,155 | 3,175,960 |
Operating lease right-of-use assets, net | 206,229 | |
Other assets | 1,433,198 | 457,476 |
Total assets | 30,242,960 | 17,134,997 |
Current liabilities: | ||
Convertible senior secured notes | 6,699,000 | |
Current portion of long-term debt | 422,131 | 1,026,168 |
Current portion of finance lease liabilities | 41,213 | 192,290 |
Current portion of operating lease liabilities | 181,585 | |
Stockholder notes | 3,612,500 | 3,612,500 |
Accounts payable | 5,008,923 | 2,277,817 |
Accrued expenses | 7,328,154 | 4,622,988 |
Income taxes payable | 1,859,434 | 1,859,434 |
Total current liabilities | 18,453,940 | 20,290,197 |
Long-term debt | 544,924 | 50,285 |
Finance lease liabilities | 49,162 | 3,365,790 |
Operating lease liabilities | 48,394 | |
Warrant liability | 181,098 | 255,734 |
Other liabilities | 3,942,948 | |
Total liabilities | 19,277,518 | 27,904,954 |
Convertible preferred stock: | ||
Total convertible preferred stock | 5,359,404 | |
Stockholders’ equity (deficit): | ||
Preferred stock, value | ||
Common stock, par value $0.01 per share; 200,000,000 shares authorized; 126,360,064 shares issued and outstanding at June 30, 2020 and 28,609,995 shares issued and outstanding at September 30, 2019 | 1,263,601 | 286,100 |
Additional paid-in capital | 289,500,131 | 238,064,947 |
Accumulated deficit | (279,798,290) | (254,480,408) |
Total stockholders' equity (deficit) | 10,965,442 | (16,129,361) |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | 30,242,960 | 17,134,997 |
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 | 5,359,404 | |
Series B convertible preferred stock | ||
Stockholders’ equity (deficit): | ||
Preferred stock, value |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2020 | Sep. 30, 2019 |
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 | 126,360,064 | 28,609,995 |
Common stock, shares outstanding | 126,360,064 | 28,609,995 |
Series A convertible preferred stock | ||
Convertible stock, par value (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 stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized | 200,000 | 200,000 |
Convertible preferred stock, shares issued | 0 | 66,451 |
Convertible preferred stock outstanding | 0 | 66,451 |
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 - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Consolidated Statements of Operations | ||||
Collaboration revenues | $ 583,848 | $ 2,292,586 | ||
Operating expenses: | ||||
Research and development | $ 8,488,143 | 4,342,539 | $ 18,718,659 | 16,349,946 |
General and administrative | 3,286,739 | 1,834,545 | 7,580,638 | 6,587,691 |
Impairment of property and equipment | 104,296 | 50,927 | 527,624 | 2,962,064 |
Total operating expenses | 11,879,178 | 6,228,011 | 26,826,921 | 25,899,701 |
Loss from operations | (11,879,178) | (5,644,163) | (26,826,921) | (23,607,115) |
Interest expense, net | 443,624 | 1,081,779 | 1,737,440 | 3,256,505 |
(Gain) loss on extinguishment of debt | (6,164,284) | 423,686 | 1,896,296 | 607,240 |
Change in fair value of redemption feature | (1,796,982) | |||
Change in fair value of warrant liability | 127,506 | (1,931,244) | (74,636) | (2,265,836) |
Loss before income taxes | (6,286,024) | (5,218,384) | (28,589,039) | (25,205,024) |
Income tax benefit | (3,271,157) | (777,500) | (3,271,157) | (777,500) |
Net loss | (3,014,867) | (4,440,884) | (25,317,882) | (24,427,524) |
Beneficial conversion feature upon issuance of Series A-1 convertible preferred stock | (61,365) | |||
Series A-1 convertible preferred stock dividends and related settlement | (158,128) | (166,133) | (462,907) | |
Deemed dividend upon modification of warrants | (3,140,009) | (829,530) | ||
Deemed dividend upon amendment of the terms of the Series A-1 convertible preferred stock | (10,328,118) | |||
Net loss attributable to common stockholders | $ (3,014,867) | $ (4,599,012) | $ (38,952,142) | $ (25,781,326) |
Per share information: | ||||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.03) | $ (0.20) | $ (0.69) | $ (1.74) |
Weighted average shares outstanding, basic and diluted (in shares) | 90,757,825 | 23,007,077 | 56,089,036 | 14,787,010 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) | Series A-1 convertible preferred stockPreferred Stock | Series A-1 convertible preferred stock | MTTR, LLC (“MTTR”)Common stock repurchase note | MTTR, LLC (“MTTR”)Additional Paid-in Capital | Common stock repurchase note | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance, beginning at Sep. 30, 2018 | $ 4,734,416 | $ 90,275 | $ 190,672,166 | $ (216,307,363) | $ (25,544,922) | |||
Balance, beginning (in shares) at Sep. 30, 2018 | 60,203 | 9,027,491 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Sale of common stock, net of issuance costs | $ 103,400 | 26,053,103 | 26,156,503 | |||||
Sale of common stock (in shares) | 10,340,000 | |||||||
Proceeds from exercise of common stock warrants | $ 61,343 | (56,993) | 4,350 | |||||
Proceeds from exercise of common stock warrants (in shares) | 6,134,307 | |||||||
Private placement sale of common stock and common stock warrants, net of costs | $ 26,804 | 19,781,513 | $ 19,808,317 | |||||
Private placement sale of common stock and common stock warrants, 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 | 446 | ||||||
Issuance of common stock in connection with conversion of senior secured notes and interest | $ 504 | 401,464 | $ 401,968 | |||||
Issuance of common stock in connection with conversion of senior secured notes and interest (in shares) | 50,394 | |||||||
Series A-1 convertible preferred stock dividends and related settlement | 462,907 | (462,907) | (462,907) | |||||
Series A-1 convertible preferred stock dividends and related settlement (in shares) | 4,628 | |||||||
Stock-based compensation expense | 1,108,766 | 1,108,766 | ||||||
Accrued directors fees settled in fully vested stock options | 49,121 | 49,121 | ||||||
Net loss | (24,427,524) | (24,427,524) | ||||||
Balance, ending at Jun. 30, 2019 | $ 5,197,323 | $ 282,330 | 237,546,229 | (244,384,145) | (6,555,586) | |||
Balance, ending (in shares) at Jun. 30, 2019 | 64,831 | 64,831 | 28,233,028 | |||||
Balance, beginning at Mar. 31, 2019 | $ 5,039,195 | $ 117,596 | 211,739,503 | (239,943,261) | (28,086,162) | |||
Balance, beginning (in shares) at Mar. 31, 2019 | 63,250 | 11,759,630 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Sale of common stock, net of issuance costs | $ 103,400 | 26,053,103 | 26,156,503 | |||||
Sale of common stock (in shares) | 10,340,000 | |||||||
Proceeds from exercise of common stock warrants | $ 61,334 | (56,984) | 4,350 | |||||
Proceeds from exercise of common stock warrants (in shares) | 6,133,398 | |||||||
Series A-1 convertible preferred stock dividends and related settlement | $ 158,128 | (158,128) | (158,128) | |||||
Series A-1 convertible preferred stock dividends and related settlement (in shares) | 1,581 | |||||||
Stock-based compensation expense | (31,265) | (31,265) | ||||||
Net loss | (4,440,884) | (4,440,884) | ||||||
Balance, ending at Jun. 30, 2019 | $ 5,197,323 | $ 282,330 | 237,546,229 | (244,384,145) | (6,555,586) | |||
Balance, ending (in shares) at Jun. 30, 2019 | 64,831 | 64,831 | 28,233,028 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Cumulative effect of adoption of ASU 2014-09 (Topic 606) | (3,649,258) | (3,649,258) | ||||||
Balance, beginning at Sep. 30, 2019 | $ 5,359,404 | $ 286,100 | 238,064,947 | (254,480,408) | (16,129,361) | |||
Balance, beginning (in shares) at Sep. 30, 2019 | 66,451 | 28,609,995 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock in connection with exercise of warrants | $ 130,034 | 1,008,866 | 1,138,900 | |||||
Issuance of common stock in connection with exercise of warrants (in shares) | 13,003,414 | |||||||
Sale of common stock, net of issuance costs | $ 72,447 | $ (72,447) | $ 344,665 | 34,004,060 | 34,348,725 | |||
Sale of common stock (in shares) | 7,244,739 | 34,466,467 | ||||||
Issuance of common stock in connection with conversion of stockholder notes and interest | $ 14,753 | 1,533,673 | $ 1,548,426 | |||||
Issuance of common stock in connection with conversion of stockholder notes and interest (in shares) | 1,475,258 | |||||||
Issuance of vested restricted stock units | $ 1 | (1) | ||||||
Issuance of vested restricted stock units (in shares) | 109 | 109 | ||||||
Issuance of common stock in connection with conversion of senior secured notes and interest | $ 122,015 | 7,872,479 | $ 7,994,494 | |||||
Issuance of common stock in connection with conversion of senior secured notes and interest (in shares) | 12,201,461 | |||||||
Series A-1 convertible preferred stock dividends and related settlement | $ 166,133 | (166,133) | (166,133) | |||||
Series A-1 convertible preferred stock dividends and related settlement (in shares) | 1,661 | 1,661 | ||||||
Stock-based compensation expense | 2,022,736 | 2,022,736 | ||||||
Net loss | (25,317,882) | (25,317,882) | ||||||
Conversion of Series A-1 convertible preferred stock to common stock | $ (5,525,537) | $ 293,586 | 5,231,951 | 5,525,537 | ||||
Conversion of Series A-1 convertible preferred stock to common stock (in shares) | (68,112) | 29,358,621 | ||||||
Balance, ending at Jun. 30, 2020 | $ 1,263,601 | 289,500,131 | (279,798,290) | 10,965,442 | ||||
Balance, ending (in shares) at Jun. 30, 2020 | 126,360,064 | |||||||
Balance, beginning at Mar. 31, 2020 | $ 897,512 | 255,361,229 | (276,783,423) | (20,524,682) | ||||
Balance, beginning (in shares) at Mar. 31, 2020 | 89,751,192 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Sale of common stock, net of issuance costs | $ 244,074 | 24,907,703 | 25,151,777 | |||||
Sale of common stock (in shares) | 24,407,411 | |||||||
Issuance of common stock in connection with conversion of senior secured notes and interest | $ 122,015 | 7,872,479 | 7,994,494 | |||||
Issuance of common stock in connection with conversion of senior secured notes and interest (in shares) | 12,201,461 | |||||||
Stock-based compensation expense | 1,358,720 | 1,358,720 | ||||||
Net loss | (3,014,867) | (3,014,867) | ||||||
Balance, ending at Jun. 30, 2020 | $ 1,263,601 | $ 289,500,131 | $ (279,798,290) | $ 10,965,442 | ||||
Balance, ending (in shares) at Jun. 30, 2020 | 126,360,064 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
OPERATING ACTIVITIES | ||
Net loss | $ (25,317,882) | $ (24,427,524) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 473,920 | 2,473,005 |
Loss on extinguishment of debt | 1,896,296 | 607,240 |
Non-cash interest expense | 235,636 | 1,314,321 |
Stock-based compensation | 2,022,736 | 1,108,766 |
Change in fair value of redemption feature | (1,796,982) | |
Change in fair value of warrant liability | (74,636) | (2,265,836) |
Impairment of property and equipment | 527,624 | 2,962,064 |
Loss on lease termination | 680,017 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 676,564 | (2,779,990) |
Other assets | (84,120) | (109,096) |
Operating lease liability | (122,193) | |
Accounts payable | 900,030 | (1,935,958) |
Accrued expenses | 215,175 | (1,090,468) |
Deferred revenue | (2,277,586) | |
Other liabilities | 55,587 | 73,531 |
Net cash used in operating activities | (19,712,228) | (26,347,531) |
INVESTING ACTIVITIES | ||
Purchase of property and equipment | (437,306) | |
Investment in joint venture | (900,000) | |
Net cash used in investing activities | (900,000) | (437,306) |
FINANCING ACTIVITIES | ||
Proceeds from the sale of common stock, net of offering costs | 34,739,271 | 45,964,820 |
Proceeds from debt | 904,200 | |
Proceeds from exercise of common stock warrants | 1,138,900 | 4,350 |
Payments of finance lease obligations | (196,959) | (470,295) |
Repayment of debt | (35,632) | (6,404,597) |
Net cash provided by financing activities | 36,549,780 | 39,094,278 |
Net increase in cash | 15,937,552 | 12,309,441 |
Cash at beginning of period | 8,015,528 | 1,717,391 |
Cash at end of period | 23,953,080 | 14,026,832 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 910,503 | 2,710,376 |
Accrued interest settled by conversion into common stock | 1,531,004 | 1,393 |
Noncash supplemental activity | ||
Purchases of property and equipment in accounts payable and accrued expenses | 1,048,286 | |
Senior secured notes principal converted into common stock | 7,033,950 | 400,575 |
Unsecured notes principal converted into common stock | 977,966 | |
Issuance of capital lease obligations in connection with purchase of property and equipment | 48,683 | |
Issuance of exchange notes at estimated fair value | 7,050,206 | |
Issuance of redemption feature at estimated fair value | 8,264,451 | |
Change in fair value of convertible senior secured notes warrants recorded as debt discount | 1,466,710 | |
Series A-1 convertible preferred stock dividends and related settlement | 166,133 | 462,907 |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses | 390,546 | |
Accrued directors' fees settled in fully vested stock options | $ 49,121 | $ 49,121 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Jun. 30, 2020 | |
Organization and Description of Business | |
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, started operations in July 2011, and 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, an ophthalmic formulation of bevacizumab for use in retinal indications. The Company is based in Monmouth Junction, New Jersey. The Company has been actively monitoring the novel coronavirus (“COVID-19”) pandemic and its impact globally. Given the Company’s current infrastructure needs and current strategy, the Company was able to transition to remote working with limited impact on productivity, as shelter-in-place and similar government orders were imposed. All clinical and chemistry, manufacturing and control activities are currently active for both NORSE 1 and NORSE 2, the Company’s two clinical trials under its Phase 3 program for ONS-5010. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. Management believes the financial results for the nine months ended June 30, 2020 were not significantly impacted by COVID-19. |
Liquidity
Liquidity | 9 Months Ended |
Jun. 30, 2020 | |
Liquidity | |
Liquidity | 2. Liquidity The Company has incurred substantial losses and negative cash flows from operations since its inception. As of June 30, 2020, the Company had $3.6 million of unsecured notes that were due on demand as of such date and $0.9 million loan granted pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), which matures on May 2, 2022. 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 July 16, 2020, the Company received $1.0 million in proceeds in connection with a securities purchase agreement entered into on June 22, 2020 with Syntone Ventures LLC (“Syntone”), a U.S. affiliate of Syntone Technologies Group Co. Ltd., a People's Republic of China (“PRC”) entity, the Company’s strategic partner for ONS-5010 in China, in a private placement pursuant to which the Company issued and sold 823,045 shares of its common stock at a purchase price of $1.215 per share. Management believes that the Company’s existing cash as of June 30, 2020, and the $1.0 million proceeds received in July 2020 from the Syntone private placement pursuant to the June 2020 securities purchase agreement will be sufficient to fund its operations through the first quarter of fiscal 2021. 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 | 9 Months Ended |
Jun. 30, 2020 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
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 June 30, 2020 and its results of operations for the three and nine months ended June 30, 2020 and 2019, cash flows for the nine months ended June 30, 2020 and 2019, and convertible preferred stock and stockholders’ equity for the three and nine months ended June 30, 2020 and 2019. Operating results for the three and nine months ended June 30, 2020 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2020. 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, 2019 included in the Company’s Annual Report on Form 10‑K filed with the Securities and Exchange Commission (“SEC”) on December 19, 2019. 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, including as a result of the ongoing COVID-19 pandemic, 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 attributable to common stockholders by the weighted-average number of shares of common stock 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. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended June 30, Nine months ended June 30, 2020 2019 2020 2019 Net loss attributable to common stockholders $ (3,014,867) $ (4,599,012) $ (38,952,142) $ (25,781,326) Common stock outstanding (weighted average) 56,089,036 14,787,010 Basic and diluted net loss per share $ (0.03) $ (0.20) $ (0.69) $ (1.74) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2020 and 2019, as they would be antidilutive: As of June 30, 2020 2019 Series A-1 convertible preferred stock — 1,225,172 Convertible senior secured notes — 767,605 Convertible unsecured notes — 149,573 Performance-based stock units 2,470 16,131 Restricted stock units — 3,750 Stock options 2,238,470 605,452 Common stock warrants 7,051,857 16,067,923 Recently issued and adopted accounting pronouncements On October 1, 2019, the Company adopted ASU No. 2016-02, Leases (“ASC 842” or “ASU 2016-02”) issued by the FASB in February 2016 which was subsequently supplemented by clarifying guidance to improve financial reporting of leasing transactions. The new lease accounting guidance requires lessees to recognize lease liabilities and right-of-use assets on the balance sheet for all leases with initial terms longer than 12 months and provides enhanced disclosures on key information of leasing arrangements. The guidance allowed companies to apply the requirements retrospectively, either to all prior periods presented or through a cumulative adjustment in the year of adoption. The Company adopted the new standard effective October 1, 2019 using the modified retrospective transition method using the package of practical expedients and a discount rate of 9% and elected to not apply the standard in the comparative periods presented in the year of adoption. The Company has implemented internal controls to monitor and record historical and future lease arrangements and required disclosures. For all existing operating leases as of September 30, 2019, the Company recorded right of use assets of $352,172 and corresponding lease liabilities of $318,672 with an offset to other liabilities of $33,500 to eliminate deferred rent on the consolidated balance sheets. The Company recorded right of use assets of $2,525,000 and corresponding finance lease liabilities of $3,558,080 for leases previously classified as capital leases. This did not include an existing lease termination obligation of $3,909,448 pertaining to a lease for premises that had been leased in Cranbury, New Jersey for a planned office and laboratory expansion that did not materialize, and which prior termination remained unchanged as a result of the transition. Refer to Note 9 for the Company’s lease disclosures. At lease commencement, the Company records a lease liability based on the present value of lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise. The Company calculates the present value of lease payments using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. At the lease commencement date, the Company records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. The Company may enter into leases with an initial term of 12 months or less (“Short-Term Leases”). For Short-Term Leases, the Company records the rent expense on a straight-line basis and does not record the leases on the consolidated balance sheet. The Company had no Short-Term Leases as of June 30, 2020. After lease commencement, the Company measures its leases as follows: (i) the lease liability based on the present value of the remaining lease payments using the discount rate determined at lease commencement and (ii) the right-of-use lease asset based on the re-measured lease liability, adjusted for any unamortized lease incentives received, any unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease agreement. Any lease incentives received, and any initial direct costs are amortized on a straight-line basis over the expected lease term. Rent expense is recorded on a straight-line basis over the expected lease term. The adoption of the new lease accounting standard did not have a material impact on the Company’s results of operations or cash flows. On October 1, 2019, the Company adopted ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Compensation , issued by the FASB in June 2018. The amendments in this ASU expanded the scope of Compensation—Stock Compensation (“Topic 718”) to include share-based payment transactions for acquiring goods and services from nonemployees. The amendments specified that Topic 718 applied to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The Company applied the new guidance to share-based payments entered after October 1, 2019 and the adoption of this standard did not have a material impact on the Company’s financial statements. In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820) : Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement ("ASU 2018-13"), which removes and modifies some existing disclosure requirements and adds others. ASU 2018-13 modifies the disclosure requirements for fair value measurements and removes the requirement to disclose (1) the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, (2) the policy for timing of transfers between levels, and (3) the valuation processes for Level 3 fair value measurements. ASU 2018-13 requires disclosure of changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The ASU is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. Early adoption is permitted for any eliminated or modified disclosures upon issuance of this ASU. The Company is currently evaluating the impact of the adoption of this standard. Reclassifications Certain reclassifications have been made to the prior year financial statements to conform to the current year presentation. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: · Level 1 - Quoted prices in active markets for identical assets or liabilities. · Level 2 - Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. · Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis: June 30, 2020 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 181,098 September 30, 2019 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 255,734 The Company evaluated a redemption feature within the senior secured notes issued in December 2019 and determined bifurcation of the redemption feature was required. The redemption feature is accounted for as a derivative instrument and re-measured at each reporting period until the redemption feature is exercised, expires, or otherwise settled. During the three months ended June 30, 2020, the remaining outstanding principal and accrued interest on the senior secured notes were exchanged for shares of its common stock and as a result, the Company wrote off the redemption feature liability as a gain on extinguishment of debt. The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability and redemption feature for the nine months ended June 30, 2020: Redemption Warrants Feature Balance at October 1, 2019 $ 255,734 $ — Addition of feature on December 20, 2019 — 8,264,451 Change in fair value (74,636) (1,796,982) Write off due to extinguishment of senior secured notes — (6,467,469) Balance at June 30, 2020 $ 181,098 $ — The warrants issued in connection with the convertible senior secured notes (see Note 8) are classified as liabilities on the accompanying consolidated balance sheet as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair value of the warrant liability is estimated using the Black-Scholes option pricing model using the following assumptions: June 30, 2020 September 30, 2019 Risk-free interest rate 0.36 % 1.56 % Remaining contractual life of warrant 4.63 years 5.38 years Expected volatility 92.1 % 89.0 % Annual dividend yield 0 % 0 % Fair value of common stock $ 1.29 per share $ 1.49 per share The fair value of the redemption feature was estimated by using a Monte Carlo simulation model and a with-and-without perspective, where the fair value of debt instrument was measured with the derivative and without the derivative and the difference is the implied fair value of the redemption feature. The value of the debt instrument with the redemption feature depended on the daily stock price path followed by the Company’s common stock price. This model simulated daily common stock prices from the issuance date through the maturity date for the debt instrument. At issuance, the Company utilized a volatility estimate of 130% based upon the observed historical volatility of both the Company and peer group for 1-year and 2-year periods. Risk-free interest rate was based upon US treasury yields. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Jun. 30, 2020 | |
Property and Equipment, Net | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net, consists of: June 30, September 30, 2020 2019 Laboratory equipment $ 1,067,351 $ 1,067,351 Leasehold improvements — 160,086 Land and building — 3,000,000 1,067,351 4,227,437 Less: accumulated depreciation and amortization (699,196) (1,051,477) $ 368,155 $ 3,175,960 Depreciation and amortization expense was $50,959 and $833,387 for the three months ended June 30, 2020 and 2019, respectively, and $178,510 and $2,473,005 for the nine months ended June 30, 2020 and 2019, respectively. On October 1, 2019, the Company adopted ASC 842, which resulted in the reclassification of property and equipment under capital leases to finance lease right-of-use assets separately disclosed on the consolidated balance sheets. Refer to Note 9 for the Company’s lease disclosures. At September 30, 2019, $3,000,000 represented the Company’s corporate office lease that was classified as a capital lease. The Company’s corporate office lease was due to mature in February 2028 and the effective interest rate on the corporate office lease was 43.9%. At September 30, 2019, $475,000 of accumulated amortization was related to capital leases. Impairment charges During the three and nine months ended June 30, 2020, the Company recorded an impairment charge of $104,296 and $527,624, respectively, primarily due to the write-off of assets held for sale after the Company determined that the carrying amount of these assets was not recoverable as result of a lease termination agreement entered into in May 2020. Refer to Note 9 for further details. During the three and nine months ended June 30, 2019, the Company wrote off certain construction in progress and laboratory equipment with a carrying amount of $50,927 and $2,962,064, respectively. 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 due to the Company changing its operations to outsource the development and manufacturing of ONS-5010. |
Other Assets
Other Assets | 9 Months Ended |
Jun. 30, 2020 | |
Other Assets | |
Other Assets | 6. Other Assets Other assets consist of: June 30, September 30, 2020 2019 Advance to PRC joint venture $ 900,000 $ — Other assets 533,198 457,476 $ 1,433,198 $ 457,476 In connection with the Syntone stock purchase agreement, on May 22, 2020, the Company and Syntone entered into a joint venture agreement pursuant to which they agreed to form a PRC joint venture that will be 80% owned by Syntone and 20% owned by the Company. Once formed, the Company intends to enter into a royalty-free license with the PRC joint venture for the development, commercialization and manufacture of the Company’s product candidate, ONS-5010 in the greater China market, which includes Hong Kong, Taiwan and Macau. The Company made the initial investment of $900,000 in June 2020. The Company expects to be required to make an additional capital contribution to the PRC joint venture of approximately $2.1 million, which will be made within four years after the establishment date in accordance with the development plan contemplated in the license agreement or on such other terms within such four-year period. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Jun. 30, 2020 | |
Accrued Expenses | |
Accrued expenses | 7. Accrued Expenses Accrued expenses consists of: June 30, September 30, 2020 2019 Compensation $ 402,212 $ 919,394 Severance and related costs 29,803 505,570 Research and development 2,642,922 1,692,040 Interest payable 1,412 934,145 Professional fees 157,353 419,216 Lease termination obligation 3,954,717 — Other accrued expenses 139,735 152,623 $ 7,328,154 $ 4,622,988 |
Debt
Debt | 9 Months Ended |
Jun. 30, 2020 | |
Debt | |
Debt | 8. Debt Senior secured notes June 30, September 30, 2020 2019 Convertible senior secured notes $ — $ 6,699,000 In December 2019, the Company entered into an exchange agreement with the holders of its $7,254,077 outstanding aggregate principal amount and accrued interest of senior secured notes (the “Old Senior Notes”) originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017, as amended on April 13, 2017, November 5, 2018, and June 28, 2019 (the “Exchange Agreement”). Pursuant to the Exchange Agreement, the holders of the Old Senior Notes exchanged the entire outstanding principal and accrued interest for new senior secured notes having an aggregate outstanding original principal amount of $7,589,027 which included an aggregate exchange fee of $334,950. The new senior secured notes were substantially similar to the Old Senior Notes, as amended through the date of the Exchange Agreement, bore interest at a rate of 12.0% per annum and would have matured December 31, 2020 (subject to extension to June 30, 2021 at the Company’s option upon payment of an extension fee equal to 3% of the outstanding balance and being in compliance with applicable Nasdaq listing requirements). The new senior secured notes were convertible, at the option of the holder, beginning April 1, 2020, into shares of the Company’s common stock at a conversion price equal to 90% of the two lowest closing bid prices in the 20 trading days immediately preceding such conversion, subject to a floor price of $0.232 per share. The conversion feature was determined to be a redemption feature and was bifurcated from the debt instrument. The estimated fair value of the redemption feature was $8,264,451 at issuance (see Note 4). The Exchange Agreement was accounted for as an extinguishment of debt. The Company recognized a loss on extinguishment of convertible senior secured notes for the Exchange Agreement during the nine months ended June 30, 2020 of $8,060,580, which amount was equal to the excess fair value of the notes and bifurcated redemption feature over the notes’ net carrying value. During the three months ended June 30, 2020, the holder of the new senior secured notes converted the entire outstanding principal and accrued interest totaling $7,994,494 for 12,201,461 shares of the Company’s common stock at an average conversion price of $0.66 per share. As of June 30, 2020, there are no longer any new senior secured notes outstanding. The Company recognized a $6,164,284 gain on extinguishment of the new senior secured notes exchanged for shares of common stock during the three and nine months ended June 30, 2020 primarily due to the redemption feature liability and write-off of unamortized debt discount. Aggregate interest expense on the Old Senior Notes and the new senior secured notes for the three months ended June 30, 2020 and 2019 was $269,437 and $526,615, respectively, and $819,498 and $1,689,533 for the nine months ended June 30, 2020 and 2019, respectively. Stockholder notes The Company previously repurchased shares of its restricted stock in exchange for notes in the amount of $800,000 that do not bear interest and are due on demand. The Company has a $2,812,500 note payable related to the previous repurchase of common stock that does not bear interest and is due on demand. Other Indebtedness The Company has other outstanding debt consisting of unsecured notes, a PPP term loan and equipment loans. June 30, September 30, 2020 2019 Unsecured notes $ — $ 977,966 Paycheck Protection Program term loan 904,200 — Equipment loans 62,855 98,487 967,055 1,076,453 Less: current portion (422,131) (1,026,168) Long-term debt $ 544,924 $ 50,285 Unsecured notes On March 7, 2019, the Company entered into a forbearance and exchange 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 12.0% per annum simple interest during such forbearance period. The Company also agreed to, at 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 or, beginning September 2019, at 95% of the average of the two lowest closing bid prices in the prior twenty trading days, as applicable. During the nine months ended June 30, 2020, the remaining unsecured notes with an aggregate carrying amount of $977,966 and accrued interest of $570,460 were exchanged for 1,475,258 shares of the Company’s common stock at an average exchange price of $1.05. As of June 30, 2020, these unsecured notes were no longer outstanding. Paycheck Protection Program term loan On May 4, 2020, the Company received $904,200 in proceeds from a loan granted pursuant to the PPP of the CARES Act. The PPP term loan is evidenced by a promissory note containing the terms and conditions for repayment of the PPP term loan. The PPP term loan provides for an initial six-month deferral of payments and any amount owed on the loan has a two-year maturity (May 2022), with an interest rate of 1% per annum. Commencing December 15, 2020, the Company is required to pay the lender equal monthly payments of principal and interest as required to fully amortize any principal amount outstanding on the PPP term loan as of December 15, 2020 by May 2, 2022. The Company has the right to prepay any amounts outstanding under this loan at any time and from time to time, in whole or in part, without penalty. During the three months ended June 30, 2019, the Company recognized interest expense related to other indebtedness of $3,480 and $33,552, respectively, and $21,634 and $181,061 for the nine months ended June 30, 2020 and 2019, respectively. |
Leases
Leases | 9 Months Ended |
Jun. 30, 2020 | |
Leases | |
Leases | 9. Leases Corporate office and warehouse leases On May 6, 2020, the Company terminated its lease agreement for approximately 66,000 square feet of office, manufacturing and laboratory space located in Cranbury, New Jersey, which previously served as its headquarters, and relocated its corporate office to Monmouth Junction, New Jersey, a site previously used as a warehouse location. The Company’s Monmouth Junction, New Jersey lease matures in September 2021. In consideration for the termination of the lease, the Company agreed to make payments to the landlord totaling $981,987, payable in eight monthly installments commencing May 1, 2020. In connection with the lease termination, the Company recorded a liability of $981,987 at May 11, 2020, the cease-use date, that represents the undiscounted future termination payments as the termination period is less than a year. The Company derecognized the assets and liabilities associated with the financing lease and recorded a charge of $680,017 to general and administrative expense. At June 30, 2020, the lease termination obligation of $731,987 is included in accounts payable on the consolidated balance sheets. A rollforward of the charges incurred to general and administrative expense for the nine months ended June 30, 2020: Balance Expensed / Accrued Cash Non-cash Balance October 1, 2019 Expense Payments Adjustments June 30, 2020 Lease termination payments $ — $ 981,987 $ (250,000) $ — $ 731,987 Assets and liabilities derecognition — (842,514) — 842,514 — Other charges — 540,544 (540,544) — $ — $ 680,017 $ (790,544) $ 842,514 $ 731,987 Equipment leases The Company has equipment leases, with terms between 12 and 36 months, recorded as finance leases. The equipment leases bear interest between 4.0% and 13.0%. Certain lease agreements contain provisions for future rent increases. Payments due under the lease contracts include minimum payments that the Company is obligated to make under the non-cancelable initial terms of the leases as the renewal terms are at the Company’s option. Lease expense is recorded as research and development or general and administrative based on the use of the leased asset. The components of lease cost for the three and nine months ended June 30, 2020 are as follows: Three months ended June 30, Nine months ended June 30, 2020 2020 Finance lease cost: Amortization of right-of-use assets $ 32,967 $ 182,967 Interest on lease liabilities 165,191 903,278 Total finance lease cost 198,158 1,086,245 Operating lease cost 43,625 130,875 Total lease cost $ 241,783 $ 1,217,120 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of June 30, 2020 were as follows: June 30, 2020 Operating leases: Right-of-use asset $ 206,229 Operating lease liabilities 229,979 Finance leases: Right-of-use asset $ — Financing lease liabilities 90,375 Weighted-average remaining lease term (years): Operating leases 1.3 Finance leases 2.3 Weighted-average discount rate: Operating leases Finance leases Other information related to leases for the nine months ended June 30, 2020 are as follows: Nine months ended June 30, 2020 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 903,278 Operating cash flows from operating leases 140,625 Financing cash flows from finance leases 196,959 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — Finance leases — Future minimum lease payments under non-cancelable leases as of June 30, 2020 are as follows for the years ending September 30: Operating leases Finance leases 2020 (remaining three months) $ 46,875 $ 19,864 2021 195,000 34,869 2022 — 29,605 2023 — 13,149 2024 — 4,383 Total undiscounted lease payments $ 241,875 $ 101,870 Less: Imputed interest 11,896 11,495 Total lease obligations $ 229,979 $ 90,375 Future minimum rental payments under non-cancelable leases prior to adoption of ASC 842, Leases, as of September 30, 2019 were as follows: Operating leases Finance leases 2020 $ 187,500 $ 1,608,067 2021 195,000 1,506,592 2022 — 1,535,809 2023 — 1,564,027 2024 — 1,593,291 Thereafter — 5,691,492 Total undiscounted lease payments $ 382,500 $ 13,499,278 Less: Imputed interest — 9,941,198 Total lease obligations $ 382,500 $ 3,558,080 Office and laboratory lease termination obligation In August 2018, the Company entered into a lease termination agreement effective September 1, 2018, to terminate the lease for unutilized 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 June 30, 2020, the lease termination obligation of $3,954,717 is included in accrued expenses on the consolidated balance sheets. A roll forward of the charges incurred to general and administrative expense for the nine months ended June 30, 2020 is as follows: Balance Expensed / Accrued Cash Balance October 1, 2019 Expense Payments June 30, 2020 Lease termination payments $ 3,909,448 $ 495,269 $ (450,000) $ 3,954,717 |
Common Stock, Convertible Prefe
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) | 9 Months Ended |
Jun. 30, 2020 | |
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | |
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) | 10. Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) Common stock In February 2020, the Company issued, in a registered direct offering, an aggregate of 7,598,426 shares of common stock and, in a concurrent private placement to the same investors, warrants to purchase up to an aggregate of 3,799,213 shares of common stock at a combined purchase price per share and accompanying warrant of $1.016 for approximately $7.7 million in gross proceeds after payment of placement agent fees and other offering costs. In a separate concurrent private placement, the Company issued 2,460,630 shares of common stock and warrants to purchase up to an aggregate of 1,230,315 shares of common stock to GMS Ventures and Investments, an affiliate of BioLexis Pte. Ltd. (“BioLexis”), the Company’s controlling stockholder and strategic partner, at a combined purchase price per share and accompanying warrant of $1.016 for $2.5 million. The warrants issued were exercisable immediately at an exercise price of $0.9535 per share and will expire four years from the issuance date. In connection with the registered direct offering and concurrent private placement of warrants to those investors, the Company issued placement agent warrants to purchase up to an aggregate of 531,890 shares of common stock, on substantially the same terms as the concurrent private placement warrants, at an exercise price of $1.27 per share and a 5-year term. Effective March 19, 2020, following approval of the Company’s stockholders, the Company issued an aggregate of 7,244,739 shares of its common stock to the four principals (who include two of its named executive officers, Messrs. Dagnon and Evanson) of MTTR, LLC (“MTTR”) pursuant to their respective consulting agreements that were entered into on January 27, 2020 concurrent with the termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Refer to Note 11 for the accounting of the restricted stock issued and Note 12 for further details on the terminated MTTR strategic partnership agreement. In June 2020, the Company issued, in a private placement, an aggregate of 16,000,000 shares of common stock to Syntone, pursuant to a stock purchase agreement entered into on May 22, 2020, at a purchase price of $1.00 per share, for aggregate gross proceeds to the Company of $16.0 million. In June 2020, the Company issued, in a registered direct offering, an aggregate of 8,407,411 shares of common stock at a purchase price of $1.215 per share, for aggregate gross proceeds to the Company of approximately $10.2 million. In connection with the registered direct offering, the Company issued placement agent warrants to purchase up to an aggregate of 588,519 shares of common stock, at an exercise price of $1.51875 per share and a 5-year term. During the nine months ended June 30, 2020 and 2019, the Company issued 109 and 446 shares of common stock, respectively, upon the vesting of RSUs. 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 “Certificate of Designation”). The shares of Series A-1 have a stated value of $100.00 per share, and rank senior to all junior securities (as defined in the Certificate of Designation). The Series A-1 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-1. The Series A-1 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. The holders of the Series A-1 had 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 could 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. On March 23, 2020, the Company issued 29,358,621 shares of its common stock upon conversion of the 68,112 shares of Series A-1 outstanding by BioLexis, pursuant to an agreement entered on January 27, 2020 with BioLexis, whereby the effective conversion rate of the Series A-1 was increased from the $18.89797 per share to $431.03447263 per share, (or an effective conversion rate of $0.232 per share) following stockholder approval of the amended terms on March 19, 2020. The amendment to the Series A-1 was deemed an extinguishment for accounting purposes. The excess fair value of common stock received over the net carrying value of the Series A-1 was $10,328,118 and reflected as a deemed dividend in the consolidated statements of operations for purposes of presenting net loss attributable to common stockholders when calculating basic and diluted loss per share. During the nine months ended June 30, 2020, the Company issued 1,661 shares of Series A-1 to settle the related dividends that were due on a quarterly basis. At June 30, 2020, there were no shares of Series A-1 outstanding. Common stock warrants As of June 30, 2020, shares of common stock issuable upon the exercise of outstanding warrants were as follows: Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share February 18, 2022 416,666 $ 12.00 December 22, 2024 277,128 $ 12.00 April 13, 2025 145,688 $ 12.00 May 31, 2025 62,438 $ 12.00 February 24, 2025 531,890 $ 1.27 February 26, 2024 5,029,528 $ 0.9535 June 22, 2025 588,519 $ 1.5188 7,051,857 On December 23, 2019, the Company amended the terms of its outstanding 15-month warrants and five-year warrants issued April 12, 2019 (the “April 2019 Warrants”), which originally had an exercise price of $2.90 per share of the Company’s common stock. The exercise price of all outstanding April 2019 Warrants was reduced to $0.2320 per share and the exercise period was amended such that all April 2019 Warrants expire on December 24, 2019. Immediately prior to expiration, all then unexercised April 2019 Warrants were automatically net exercised pursuant to the amended provisions. On January 27, 2020, the Company amended the exercise price of its outstanding warrants to purchase an aggregate 4,657,852 shares of its common, all of which were held by BioLexis, to $0.232 per share. BioLexis exercised all such warrants for cash payment of approximately $1.1 million on January 29, 2020. The estimated change in fair value of warrants amended during the nine months ended June 30, 2020 was $3,140,009, and reflected as a deemed dividend in the consolidated statements of operations for purposes of presenting net loss attributable to common stockholders when calculating basic and diluted loss per share. During the nine months ended June 30, 2020, warrants to purchase an aggregate of 15,085,240 shares of common stock with a weighted averaged exercise price of $0.232 were exercised for an aggregate 13,003,414 shares of the Company's common stock; and warrants to purchase an aggregate of 80,797 shares of common stock with a weighted averaged exercise price of $0.08 expired. In aggregate, 10,157,050 of the exercised warrants were April 2019 Warrants, described above, exercised pursuant to the net exercise provisions therein, as amended. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Jun. 30, 2020 | |
Stock-Based Compensation | |
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 June 30, 2020, PSUs representing 2,470 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 4,022,526. As of June 30, 2020, 1,614,404 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 one 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 nine months ended June 30, 2020 and 2019: Three months ended June 30, Nine months ended June 30, 2020 2019 2020 2019 Research and development $ 915,974 $ (207,015) $ 1,064,912 $ 4,957 General and administrative 442,746 175,750 957,824 1,103,809 $ 1,358,720 $ (31,265) $ 2,022,736 $ 1,108,766 During the nine months ended June 30, 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 June 30, 2020, 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, 2019 1,389,999 $ 3.46 Granted 1,115,810 1.00 Forfeited (267,339) 2.74 Balance at June 30, 2020 2,238,470 2.32 9.2 Vested and exercisable 551,799 3.34 8.9 Vested and expected to vest at June 30, 2020 2,238,470 $ 2.32 9.2 As of June 30, 2020, the aggregate intrinsic value of options outstanding was $388,541. 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 nine months ended June 30, 2020 and 2019 was $0.71 and $4.70 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: Nine months ended June 30, 2020 2019 Risk-free interest rate 1.08 % 2.46 % Expected life (years) 5.73 6.00 Expected volatility 89.3 % 89.5 % Expected dividend yield — — As of June 30, 2020, there was $2,110,777 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 2.72 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 nine months ended June 30, 2020: Weighted Average Number Base Remaining of Price Contractual PSUs Per PSU Term (Years) Balance at October 1, 2019 15,691 $ 49.97 Forfeitures (13,221) 50.60 Balance at June 30, 2020 2,470 49.97 4.0 Vested and exercisable at June 30, 2020 2,470 49.97 4.0 Vested and expected to vest at June 30, 2020 2,470 $ 49.97 4.0 Restricted stock units The following table summarizes the activity related to RSUs during the nine months ended June 30, 2020: Weighted Number Average of Grant Date RSUs Fair Value Balance at October 1, 2019 109 $ 96.00 Vested and settled (109) 96.00 Balance at June 30, 2020 — $ — Restricted stock In connection with the consulting agreements entered into by the Company and four principals of MTTR, the Company issued an aggregate of 7,244,739 shares of its common stock. Refer to Note 12 for further details on the consulting agreements and terminated strategic partnership agreement. The shares may not be sold until the earlier of (i) six months following FDA approval of ONS-5010, (ii) the date the Company publicly announces not to pursue development of ONS-5010, (iii) a change in control or (iv) January 2025. In addition, the Company has the right to repurchase the shares for $0.01 per share if the consultant terminates his agreement other than for good reason or the Company terminates the agreement for cause. The repurchase right lapses, in tiered percentages, based upon the completion of enrollment of the Company’s NORSE 2 clinical trial of ONS-5010 by certain dates. The repurchase right may also lapse as to 50% or 100% of the shares if the Company enters into certain agreements pertaining to ONS-5010 that meet certain value thresholds or the Company’s share price meets certain predefined targets. The repurchase right also lapses as to 100% of the shares upon the earliest to occur of (i) filing of the biologics license application for ONS-5010, (ii) termination of the agreement by the consultant for good reason or by the Company other than for cause. (iii) in the event of disability, or (iv) upon a change in control. The grant date fair value of the restricted shares was $0.54 per share and equal to the closing stock price of the Company’s common stock at the time of grant. Compensation expense is recognized over the shorter of the explicit service period or derived service period which was determined to be 4.8 years at the time of grant. Compensation expense may be accelerated when certain performance conditions become probable and the corresponding purchase right has lapsed. During the three and nine months ended June 30, 2020, the Company recognized compensation expense related to the restricted stock of $1,070,404, and $1,149,387, respectively. As of June 30, 2020, there was $2,762,772 of unrecognized compensation expense related to the restricted stock. |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Jun. 30, 2020 | |
Related-Party Transactions | |
Related-Party Transactions | 12. Related-Party Transactions MTTR - strategic partnership agreement (ONS-5010) 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. In November 2018, the board of directors of the Company appointed Mr. Terry Dagnon as Chief Operating Officer, and Mr. Jeff Evanson as Chief Commercial Officer. Both Mr. Dagnon and Mr. Evanson initially provided services to the Company pursuant to the February 2018 strategic partnership agreement with MTTR, as amended. Mr. Dagnon and Mr. Evanson were both principals in MTTR. The Company did not pay Mr. Dagnon or Mr. Evanson any direct compensation as consultants or as employees during the nine months ended June 30, 2019 nor during the period from October 1, 2019 through March 19, 2020. Both Mr. Dagnon and Mr. Evanson were compensated directly by MTTR for services provided to the Company as the Company's Chief Operating Officer and Chief Commercial Officer, respectively, pursuant to the strategic partnership agreement until such agreement, as amended, was terminated effective March 19, 2020. The Company began compensating Mr. Dagnon and Mr. Evanson directly as consultants effective March 19, 2020 pursuant to their respective consulting agreements with the Company, which became effective March 19, 2020 following stockholder approval of the share issuances contemplated therein. Mr. Dagnon and Mr. Evanson have also agreed to provide consulting services to an affiliate of BioLexis pursuant to a separate arrangement. On January 27, 2020, the Company entered into a termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Pursuant to the agreement, the Company agreed (x) to issue to the four principals of MTTR (who include two of its named executive officers, Messrs. Dagnon and Evanson), an aggregate of 7,244,739 shares of its common stock, subject to stockholder approval, (y) to enter into consulting agreements with each of the four principals setting forth the terms of his respective compensation arrangement, and (z) to pay MTTR a one-time settlement fee of $110,000, upon effectiveness of the agreement. Concurrently, the Company also entered into consulting agreements directly with each of the four principals of MTTR setting forth the terms of his respective compensation arrangement, as well as providing for certain transfer restrictions and repurchase rights applicable to the shares of common stock to be issued pursuant hereto. The termination agreement, and the consulting agreements, became effective upon stockholder approval of the share issuance on March 19, 2020. Refer to Note 11 for the accounting of the restricted stock issued and compensation expense recognized. MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate $242,603 and $573,983 during the three months ended June 30, 2020 and 2019, respectively; and $1,023,374 and $1,154,894 during the nine months ended June 30, 2020 and 2019, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 11). As of June 30, 2020, an aggregate $89,762 was due to the former MTTR principals as consultants, which is included in accounts payable in the accompanying consolidated balance sheets. As of September 30, 2019, $365,301 was due to MTTR which is included in accrued expenses in the accompanying consolidated balance sheets. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Jun. 30, 2020 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events Syntone Purchase Agreement On July 16, 2020, the Company received $1.0 million in proceeds in connection with a securities purchase agreement entered into on June 22, 2020 with Syntone, in a private placement pursuant to which the Company issued and sold 823,045 shares of its common stock at a purchase price of $1.215 per share. Stock options grants In July 2020, the Company granted 1,581,256 stock options with a weighted average exercise price of $1.57 and grant date fair value of $1.14. Litigation On July 20, 2020, Laboratorios Liomont S.A. de C.V. (“Liomont”), filed a complaint against the Company in the U.S. District Court of the Southern District of New York alleging certain breach of contract claims under the June 25, 2014 strategic development, license and supply agreement relating to the biosimilar development program for ONS-3010 and ONS-1045. According to the complaint, Liomont is claiming $3,000,000 damages due. The Company disputes the claims in the Liomont complaint, believes they are without merit, and intends to defend against these claims vigorously. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Jun. 30, 2020 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
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 June 30, 2020 and its results of operations for the three and nine months ended June 30, 2020 and 2019, cash flows for the nine months ended June 30, 2020 and 2019, and convertible preferred stock and stockholders’ equity for the three and nine months ended June 30, 2020 and 2019. Operating results for the three and nine months ended June 30, 2020 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2020. 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, 2019 included in the Company’s Annual Report on Form 10‑K filed with the Securities and Exchange Commission (“SEC”) on December 19, 2019. |
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, including as a result of the ongoing COVID-19 pandemic, 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 attributable to common stockholders by the weighted-average number of shares of common stock 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. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following table sets forth the computation of basic earnings per share and diluted earnings per share: Three months ended June 30, Nine months ended June 30, 2020 2019 2020 2019 Net loss attributable to common stockholders $ (3,014,867) $ (4,599,012) $ (38,952,142) $ (25,781,326) Common stock outstanding (weighted average) 56,089,036 14,787,010 Basic and diluted net loss per share $ (0.03) $ (0.20) $ (0.69) $ (1.74) The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2020 and 2019, as they would be antidilutive: As of June 30, 2020 2019 Series A-1 convertible preferred stock — 1,225,172 Convertible senior secured notes — 767,605 Convertible unsecured notes — 149,573 Performance-based stock units 2,470 16,131 Restricted stock units — 3,750 Stock options 2,238,470 605,452 Common stock warrants 7,051,857 16,067,923 |
Recently issued and adopted accounting pronouncements | Recently issued and adopted accounting pronouncements On October 1, 2019, the Company adopted ASU No. 2016-02, Leases (“ASC 842” or “ASU 2016-02”) issued by the FASB in February 2016 which was subsequently supplemented by clarifying guidance to improve financial reporting of leasing transactions. The new lease accounting guidance requires lessees to recognize lease liabilities and right-of-use assets on the balance sheet for all leases with initial terms longer than 12 months and provides enhanced disclosures on key information of leasing arrangements. The guidance allowed companies to apply the requirements retrospectively, either to all prior periods presented or through a cumulative adjustment in the year of adoption. The Company adopted the new standard effective October 1, 2019 using the modified retrospective transition method using the package of practical expedients and a discount rate of 9% and elected to not apply the standard in the comparative periods presented in the year of adoption. The Company has implemented internal controls to monitor and record historical and future lease arrangements and required disclosures. For all existing operating leases as of September 30, 2019, the Company recorded right of use assets of $352,172 and corresponding lease liabilities of $318,672 with an offset to other liabilities of $33,500 to eliminate deferred rent on the consolidated balance sheets. The Company recorded right of use assets of $2,525,000 and corresponding finance lease liabilities of $3,558,080 for leases previously classified as capital leases. This did not include an existing lease termination obligation of $3,909,448 pertaining to a lease for premises that had been leased in Cranbury, New Jersey for a planned office and laboratory expansion that did not materialize, and which prior termination remained unchanged as a result of the transition. Refer to Note 9 for the Company’s lease disclosures. At lease commencement, the Company records a lease liability based on the present value of lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise. The Company calculates the present value of lease payments using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. At the lease commencement date, the Company records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. The Company may enter into leases with an initial term of 12 months or less (“Short-Term Leases”). For Short-Term Leases, the Company records the rent expense on a straight-line basis and does not record the leases on the consolidated balance sheet. The Company had no Short-Term Leases as of June 30, 2020. After lease commencement, the Company measures its leases as follows: (i) the lease liability based on the present value of the remaining lease payments using the discount rate determined at lease commencement and (ii) the right-of-use lease asset based on the re-measured lease liability, adjusted for any unamortized lease incentives received, any unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease agreement. Any lease incentives received, and any initial direct costs are amortized on a straight-line basis over the expected lease term. Rent expense is recorded on a straight-line basis over the expected lease term. The adoption of the new lease accounting standard did not have a material impact on the Company’s results of operations or cash flows. On October 1, 2019, the Company adopted ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Compensation , issued by the FASB in June 2018. The amendments in this ASU expanded the scope of Compensation—Stock Compensation (“Topic 718”) to include share-based payment transactions for acquiring goods and services from nonemployees. The amendments specified that Topic 718 applied to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The Company applied the new guidance to share-based payments entered after October 1, 2019 and the adoption of this standard did not have a material impact on the Company’s financial statements. In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820) : Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement ("ASU 2018-13"), which removes and modifies some existing disclosure requirements and adds others. ASU 2018-13 modifies the disclosure requirements for fair value measurements and removes the requirement to disclose (1) the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, (2) the policy for timing of transfers between levels, and (3) the valuation processes for Level 3 fair value measurements. ASU 2018-13 requires disclosure of changes in unrealized gains and losses for the period included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The ASU is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. Early adoption is permitted for any eliminated or modified disclosures upon issuance of this ASU. The Company is currently evaluating the impact of the adoption of this standard. |
Reclassifications | Reclassifications Certain reclassifications have been made to the prior year financial statements to conform to the current year presentation. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Schedule of computation of basic earnings per share and diluted earnings per share | Three months ended June 30, Nine months ended June 30, 2020 2019 2020 2019 Net loss attributable to common stockholders $ (3,014,867) $ (4,599,012) $ (38,952,142) $ (25,781,326) Common stock outstanding (weighted average) 56,089,036 14,787,010 Basic and diluted net loss per share $ (0.03) $ (0.20) $ (0.69) $ (1.74) |
Schedule of dilutive securities excluded from the computation weighted-average shares | As of June 30, 2020 2019 Series A-1 convertible preferred stock — 1,225,172 Convertible senior secured notes — 767,605 Convertible unsecured notes — 149,573 Performance-based stock units 2,470 16,131 Restricted stock units — 3,750 Stock options 2,238,470 605,452 Common stock warrants 7,051,857 16,067,923 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured at fair value on a recurring basis | June 30, 2020 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 181,098 September 30, 2019 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 255,734 |
Schedule of changes in the fair value of Level 3 valuation for the warrant liability | Redemption Warrants Feature Balance at October 1, 2019 $ 255,734 $ — Addition of feature on December 20, 2019 — 8,264,451 Change in fair value (74,636) (1,796,982) Write off due to extinguishment of senior secured notes — (6,467,469) Balance at June 30, 2020 $ 181,098 $ — |
Schedule of fair value of the warrant liability | June 30, 2020 September 30, 2019 Risk-free interest rate 0.36 % 1.56 % Remaining contractual life of warrant 4.63 years 5.38 years Expected volatility 92.1 % 89.0 % Annual dividend yield 0 % 0 % Fair value of common stock $ 1.29 per share $ 1.49 per share |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Property and Equipment, Net | |
Schedule of property and equipment | June 30, September 30, 2020 2019 Laboratory equipment $ 1,067,351 $ 1,067,351 Leasehold improvements — 160,086 Land and building — 3,000,000 1,067,351 4,227,437 Less: accumulated depreciation and amortization (699,196) (1,051,477) $ 368,155 $ 3,175,960 |
Other Asset (Tables)
Other Asset (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Other Assets | |
Schedule of other assets | June 30, September 30, 2020 2019 Advance to PRC joint venture $ 900,000 $ — Other assets 533,198 457,476 $ 1,433,198 $ 457,476 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Accrued Expenses | |
Schedule of accrued expenses | June 30, September 30, 2020 2019 Compensation $ 402,212 $ 919,394 Severance and related costs 29,803 505,570 Research and development 2,642,922 1,692,040 Interest payable 1,412 934,145 Professional fees 157,353 419,216 Lease termination obligation 3,954,717 — Other accrued expenses 139,735 152,623 $ 7,328,154 $ 4,622,988 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Debt | |
Schedule of senior secured note | June 30, September 30, 2020 2019 Convertible senior secured notes $ — $ 6,699,000 |
Schedule of other indebtedness | June 30, September 30, 2020 2019 Unsecured notes $ — $ 977,966 Paycheck Protection Program term loan 904,200 — Equipment loans 62,855 98,487 967,055 1,076,453 Less: current portion (422,131) (1,026,168) Long-term debt $ 544,924 $ 50,285 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Leases | |
Schedule of lease information | The components of lease cost for the three and nine months ended June 30, 2020 are as follows: Three months ended June 30, Nine months ended June 30, 2020 2020 Finance lease cost: Amortization of right-of-use assets $ 32,967 $ 182,967 Interest on lease liabilities 165,191 903,278 Total finance lease cost 198,158 1,086,245 Operating lease cost 43,625 130,875 Total lease cost $ 241,783 $ 1,217,120 Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of June 30, 2020 were as follows: June 30, 2020 Operating leases: Right-of-use asset $ 206,229 Operating lease liabilities 229,979 Finance leases: Right-of-use asset $ — Financing lease liabilities 90,375 Weighted-average remaining lease term (years): Operating leases 1.3 Finance leases 2.3 Weighted-average discount rate: Operating leases Finance leases Other information related to leases for the nine months ended June 30, 2020 are as follows: Nine months ended June 30, 2020 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 903,278 Operating cash flows from operating leases 140,625 Financing cash flows from finance leases 196,959 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — Finance leases — |
Schedule of operating lease future minimum payments | Future minimum lease payments under non-cancelable leases as of June 30, 2020 are as follows for the years ending September 30: Operating leases Finance leases 2020 (remaining three months) $ 46,875 $ 19,864 2021 195,000 34,869 2022 — 29,605 2023 — 13,149 2024 — 4,383 Total undiscounted lease payments $ 241,875 $ 101,870 Less: Imputed interest 11,896 11,495 Total lease obligations $ 229,979 $ 90,375 |
Schedule of finance lease future minimum payments | Operating leases Finance leases 2020 (remaining three months) $ 46,875 $ 19,864 2021 195,000 34,869 2022 — 29,605 2023 — 13,149 2024 — 4,383 Total undiscounted lease payments $ 241,875 $ 101,870 Less: Imputed interest 11,896 11,495 Total lease obligations $ 229,979 $ 90,375 |
Schedule of prior year minimum rental payments in operating leases | Operating leases Finance leases 2020 $ 187,500 $ 1,608,067 2021 195,000 1,506,592 2022 — 1,535,809 2023 — 1,564,027 2024 — 1,593,291 Thereafter — 5,691,492 Total undiscounted lease payments $ 382,500 $ 13,499,278 Less: Imputed interest — 9,941,198 Total lease obligations $ 382,500 $ 3,558,080 |
Schedule of prior year minimum rental payments in capital leases | Future minimum rental payments under non-cancelable leases prior to adoption of ASC 842, Leases, as of September 30, 2019 were as follows: Operating leases Finance leases 2020 $ 187,500 $ 1,608,067 2021 195,000 1,506,592 2022 — 1,535,809 2023 — 1,564,027 2024 — 1,593,291 Thereafter — 5,691,492 Total undiscounted lease payments $ 382,500 $ 13,499,278 Less: Imputed interest — 9,941,198 Total lease obligations $ 382,500 $ 3,558,080 |
Cranbury, New Jersey, Lease Termination Two | |
Leases | |
Schedule of future termination payment derecognized assets and liabilities associated with financing lease | Balance Expensed / Accrued Cash Non-cash Balance October 1, 2019 Expense Payments Adjustments June 30, 2020 Lease termination payments $ — $ 981,987 $ (250,000) $ — $ 731,987 Assets and liabilities derecognition — (842,514) — 842,514 — Other charges — 540,544 (540,544) — $ — $ 680,017 $ (790,544) $ 842,514 $ 731,987 |
Cranbury, New Jersey, Lease Termination One | |
Leases | |
Schedule of future termination payment derecognized assets and liabilities associated with financing lease | Balance Expensed / Accrued Cash Balance October 1, 2019 Expense Payments June 30, 2020 Lease termination payments $ 3,909,448 $ 495,269 $ (450,000) $ 3,954,717 |
Common Stock, Convertible Pre_2
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | |
Schedule of warrants outstanding | Shares of common stock issuable upon exercise of Exercise Price Expiration Date warrants Per Share February 18, 2022 416,666 $ 12.00 December 22, 2024 277,128 $ 12.00 April 13, 2025 145,688 $ 12.00 May 31, 2025 62,438 $ 12.00 February 24, 2025 531,890 $ 1.27 February 26, 2024 5,029,528 $ 0.9535 June 22, 2025 588,519 $ 1.5188 7,051,857 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2020 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three months ended June 30, Nine months ended June 30, 2020 2019 2020 2019 Research and development $ 915,974 $ (207,015) $ 1,064,912 $ 4,957 General and administrative 442,746 175,750 957,824 1,103,809 $ 1,358,720 $ (31,265) $ 2,022,736 $ 1,108,766 |
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, 2019 1,389,999 $ 3.46 Granted 1,115,810 1.00 Forfeited (267,339) 2.74 Balance at June 30, 2020 2,238,470 2.32 9.2 Vested and exercisable 551,799 3.34 8.9 Vested and expected to vest at June 30, 2020 2,238,470 $ 2.32 9.2 |
Schedule of weighted-average assumptions used in option pricing model for stock options | Nine months ended June 30, 2020 2019 Risk-free interest rate 1.08 % 2.46 % Expected life (years) 5.73 6.00 Expected volatility 89.3 % 89.5 % 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, 2019 15,691 $ 49.97 Forfeitures (13,221) 50.60 Balance at June 30, 2020 2,470 49.97 4.0 Vested and exercisable at June 30, 2020 2,470 49.97 4.0 Vested and expected to vest at June 30, 2020 2,470 $ 49.97 4.0 |
Schedule of restricted stock units activity | Weighted Number Average of Grant Date RSUs Fair Value Balance at October 1, 2019 109 $ 96.00 Vested and settled (109) 96.00 Balance at June 30, 2020 — $ — |
Liquidity (Details)
Liquidity (Details) - USD ($) | Jul. 16, 2020 | May 04, 2020 | Mar. 19, 2020 | Jun. 30, 2020 | Jun. 30, 2019 |
Liquidity | |||||
Unsecured debt | $ 3,600,000 | ||||
Proceeds from loan | 904,200 | ||||
Proceeds from the sale of common stock, net of offering costs | 34,739,271 | $ 45,964,820 | |||
Number of share issued | 7,244,739 | ||||
Subsequent Event | |||||
Liquidity | |||||
Proceeds from the sale of common stock, net of offering costs | $ 1,000,000 | ||||
Number of share issued | 823,045 | ||||
Shares issued, price per share | $ 1.215 | ||||
Paycheck Protection Program | |||||
Liquidity | |||||
Proceeds from loan | $ 904,200 | $ 900,000 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Basic and diluted earnings per share: | ||||
Net loss attributable to common stockholders | $ (3,014,867) | $ (4,599,012) | $ (38,952,142) | $ (25,781,326) |
Common stock outstanding (weighted average) | 90,757,825 | 23,007,077 | 56,089,036 | 14,787,010 |
Basic and diluted net loss per share (in dollars per share) | $ (0.03) | $ (0.20) | $ (0.69) | $ (1.74) |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares | 9 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
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 | 1,225,172 | |
Senior Notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 767,605 | |
Unsecured notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 149,573 | |
Performance-based stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 2,470 | 16,131 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 3,750 | |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 2,238,470 | 605,452 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 7,051,857 | 16,067,923 |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Info (Details) - USD ($) | Jun. 30, 2020 | Oct. 01, 2019 |
New accounting pronouncements | ||
Operating lease right-of-use assets, net | $ 206,229 | |
Operating leases, Lease obligation | 241,875 | |
Finance leases, Lease obligation | $ 101,870 | |
Lease termination obligation | $ 3,909,448 | |
ASU 2016-02 Leases | Restatement adjustment | ||
New accounting pronouncements | ||
Assumed discount rate (as a percent) | 9.00% | |
Operating lease right-of-use assets, net | $ 352,172 | |
Operating leases, Lease obligation | 318,672 | |
Deferred rent | 33,500 | |
Finance lease right-of-use assets, net | 2,525,000 | |
Finance leases, Lease obligation | $ 3,558,080 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Jun. 30, 2020 | Sep. 30, 2019 | Jun. 30, 2019 |
Liabilities | |||
Warrant liability | $ 181,098 | $ 255,734 | |
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 | $ 181,098 | $ 255,734 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in fair value (Details) | 9 Months Ended |
Jun. 30, 2020USD ($) | |
Warrant | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance, beginning | $ 255,734 |
Change in fair value | (74,636) |
Balance, ending | 181,098 |
Redemption feature | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance, beginning | 0 |
Addition of feature on December 20, 2019 | 8,264,451 |
Change in fair value | (1,796,982) |
Write off due to extinguishment of senior secured notes | (6,467,469) |
Balance, ending | $ 0 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions (Details) | Jun. 30, 2020$ / sharesUSD ($) | Sep. 30, 2019$ / sharesUSD ($) |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 0.36 | 1.56 |
Remaining contractual life of warrant | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 4.63 | 5.38 |
Remaining contractual life of warrant | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Redemption feature input | 1 | |
Remaining contractual life of warrant | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Redemption feature input | 2 | |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant inputs | 92.1 | 89 |
Redemption feature input | 130 | |
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 | $ / shares | 1.29 | 1.49 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) | Jun. 30, 2020 | Sep. 30, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,067,351 | $ 4,227,437 |
Less: accumulated depreciation and amortization | (699,196) | (1,051,477) |
Property and equipment, net | 368,155 | 3,175,960 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,067,351 | 1,067,351 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 0 | 160,086 |
Land and building | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 0 | $ 3,000,000 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Sep. 30, 2019 | |
Property, Plant and Equipment [Line Items] | |||||
Depreciation and amortization expense | $ 50,959 | $ 833,387 | $ 178,510 | $ 2,473,005 | |
Finance leases, Weighted-average discount rate (as a percent) | 8.10% | 8.10% | |||
Finance lease accumulated amortization | $ 475,000 | ||||
Impairment of property and equipment | $ 104,296 | $ 50,927 | $ 527,624 | $ 2,962,064 | |
Land and building | |||||
Property, Plant and Equipment [Line Items] | |||||
Finance leases, Right-of-use asset | $ 3,000,000 | ||||
Finance leases, Weighted-average discount rate (as a percent) | 43.90% |
Other Assets (Details)
Other Assets (Details) - USD ($) | Jun. 30, 2020 | Sep. 30, 2019 |
Other Assets | ||
Advance to PRC joint venture | $ 900,000 | |
Other assets | 533,198 | $ 457,476 |
Total other assets | $ 1,433,198 | $ 457,476 |
Other Assets - Additional infor
Other Assets - Additional information (Details) - USD ($) | May 22, 2020 | Jun. 30, 2020 | Jun. 30, 2020 |
Schedule of Equity Method Investments [Line Items] | |||
Investment in joint venture | $ 900,000 | ||
P R C Joint Venture | |||
Schedule of Equity Method Investments [Line Items] | |||
Ownership percentage | 20.00% | ||
Investment in joint venture | $ 900,000 | ||
Expected future investment | $ 2,100,000 | ||
Contract period | 4 years | ||
Syntone | P R C Joint Venture | |||
Schedule of Equity Method Investments [Line Items] | |||
Ownership percentage | 80.00% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2020 | Sep. 30, 2019 |
Accrued Expenses | ||
Compensation | $ 402,212 | $ 919,394 |
Severance and related costs | 29,803 | 505,570 |
Research and development | 2,642,922 | 1,692,040 |
Interest payable | 1,412 | 934,145 |
Professional fees | 157,353 | 419,216 |
Lease termination obligation | 3,954,717 | |
Other accrued expenses | 139,735 | 152,623 |
Accrued expenses, total | $ 7,328,154 | $ 4,622,988 |
Debt (Details)
Debt (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 |
Debt Instrument [Line Items] | |||
Convertible senior secured notes | $ 6,699,000 | ||
Senior Notes | |||
Debt Instrument [Line Items] | |||
Convertible senior secured notes | $ 0 | $ 7,589,027 | $ 6,699,000 |
Debt - Additional information (
Debt - Additional information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Dec. 31, 2019USD ($)Ditem | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)$ / shares | Jun. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |
Debt Instrument [Line Items] | ||||||
Convertible senior secured notes | $ 6,699,000 | |||||
Loss on extinguishment of debt | $ 6,164,284 | $ (423,686) | $ (1,896,296) | $ (607,240) | ||
Stockholder notes | 3,612,500 | 3,612,500 | 3,612,500 | |||
Senior Notes | ||||||
Debt Instrument [Line Items] | ||||||
Convertible senior secured notes | $ 7,589,027 | 0 | $ 0 | $ 6,699,000 | ||
Bank exchange fee | $ 334,950 | |||||
Interest rate (as a percent) | 12.00% | |||||
Extension fee (as a percent) | 3.00% | |||||
Stock price threshold (as a percent) | 90.00% | |||||
Number of lowest closing bid prices | item | 2 | |||||
Trading day threshold | D | 20 | |||||
Floor price | $ / shares | $ 0.232 | |||||
Redemption feature | $ 8,264,451 | |||||
Loss on extinguishment of debt | $ 6,164,284 | |||||
Interest expense | 269,437 | $ 526,615 | $ 819,498 | $ 1,689,533 | ||
Carrying value of notes exchanged | $ 7,254,077 | $ 7,994,494 | ||||
Common stock issued up on conversion of stockholder notes (in shares) | shares | 12,201,461 | |||||
Conversion rate per share | $ / shares | $ 0.66 | $ 0.66 | ||||
Convertible Senior Notes | ||||||
Debt Instrument [Line Items] | ||||||
Loss on extinguishment of debt | $ (8,060,580) | |||||
Restricted stock purchase notes | ||||||
Debt Instrument [Line Items] | ||||||
Stockholder notes | $ 800,000 | 800,000 | ||||
Common stock repurchase note | ||||||
Debt Instrument [Line Items] | ||||||
Stockholder notes | $ 2,812,500 | $ 2,812,500 |
Debt -Other Indebtedness (Detai
Debt -Other Indebtedness (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Sep. 30, 2019 |
Debt Instrument [Line Items] | ||
Total debt | $ 967,055 | $ 1,076,453 |
Less: current portion | 422,131 | 1,026,168 |
Long-term debt | 544,924 | 50,285 |
Unsecured notes | ||
Debt Instrument [Line Items] | ||
Total debt | 977,966 | |
Paycheck Protection Program | ||
Debt Instrument [Line Items] | ||
Total debt | 904,200 | |
Equipment loan | ||
Debt Instrument [Line Items] | ||
Total debt | $ 62,855 | $ 98,487 |
Debt - Unsecured notes & PPP te
Debt - Unsecured notes & PPP term loan (Details) | May 04, 2020USD ($) | Jun. 30, 2020USD ($)item$ / shares | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)Ditem$ / sharesshares | Jun. 30, 2019USD ($) | Mar. 07, 2020USD ($) |
Debt Instrument [Line Items] | ||||||
Proceeds from loan | $ 904,200 | |||||
Paycheck Protection Program | ||||||
Debt Instrument [Line Items] | ||||||
Interest rate (as a percent) | 1.00% | |||||
Proceeds from loan | $ 904,200 | $ 900,000 | ||||
Deferral term | 6 months | |||||
Debt Instrument, term | 2 years | |||||
Unsecured notes | ||||||
Debt Instrument [Line Items] | ||||||
Total other indebtedness | $ 1,947,133 | |||||
Original principal amount | $ 1,000,000 | |||||
Monthly stated interest rate | 2.50% | |||||
Interest rate (as a percent) | 12.00% | 12.00% | ||||
Conversion rate per share | $ / shares | $ 13.44 | $ 13.44 | ||||
Stock price threshold (as a percent) | 95.00% | |||||
Number of lowest closing bid prices | item | 2 | 2 | ||||
Trading day threshold | D | 20 | |||||
Carrying value of notes exchanged | $ 977,966 | |||||
Accrued interest of notes exchanged | $ 570,460 | |||||
Common stock issued up on conversion of stockholder notes (in shares) | shares | 1,475,258 | |||||
Weighted average exchange price (per share) | $ / shares | $ 1.05 | $ 1.05 | ||||
Interest expense | $ 3,480 | $ 33,552 | $ 21,634 | $ 181,061 |
Leases - Lease termination (Det
Leases - Lease termination (Details) | May 11, 2020USD ($) | May 06, 2020USD ($)ft² | Aug. 31, 2018USD ($) | Jun. 30, 2020USD ($) | Oct. 01, 2019USD ($) | Sep. 30, 2019USD ($) |
Commitment | ||||||
Lease termination obligation | $ 3,909,448 | |||||
Loss on lease termination | $ (680,017) | |||||
Cranbury, New Jersey, Lease Termination Two | ||||||
Commitment | ||||||
Net rentable area | ft² | 66,000 | |||||
Lease termination obligation | $ 981,987 | $ 981,987 | 731,987 | |||
Terms of payment for lease | 8 months | |||||
Loss on lease termination | $ (680,017) | |||||
Cranbury, New Jersey, Lease Termination One | ||||||
Commitment | ||||||
Lease termination obligation | $ 5,800,000 | $ 3,954,717 | $ 3,909,448 | |||
Terms of payment for lease | 30 months | |||||
Amount of execution of termination agreement | $ 287,615 | |||||
Payment for lease per month | 50,000 | |||||
Lease payment in any event | 4,000,000 | |||||
Security deposit | $ 174,250 |
Leases - Lease termination roll
Leases - Lease termination rollforward (Details) | 9 Months Ended |
Jun. 30, 2020USD ($) | |
Cranbury, New Jersey, Lease Termination Two | |
Leases | |
Expensed accrued expense | $ 680,017 |
Cash payments | (790,544) |
Non cash items | 842,514 |
Balance, ending | 731,987 |
Cranbury, New Jersey, Lease Termination Two | Lease termination payments | |
Leases | |
Expensed accrued expense | 981,987 |
Cash payments | (250,000) |
Balance, ending | 731,987 |
Cranbury, New Jersey, Lease Termination Two | Assets and liabilities derecognition | |
Leases | |
Expensed accrued expense | (842,514) |
Non cash items | 842,514 |
Cranbury, New Jersey, Lease Termination Two | Other charges | |
Leases | |
Expensed accrued expense | 540,544 |
Cash payments | (540,544) |
Cranbury, New Jersey, Lease Termination One | |
Leases | |
Balance, beginning | 3,909,448 |
Expensed accrued expense | 495,269 |
Cash payments | (450,000) |
Balance, ending | $ 3,954,717 |
Leases - Lease cost (Details)
Leases - Lease cost (Details) | 3 Months Ended | 9 Months Ended |
Jun. 30, 2020USD ($) | Jun. 30, 2020USD ($) | |
Lease cost | ||
Amortization of right-of-use assets | $ 32,967 | $ 182,967 |
Interest on lease liabilities | 165,191 | 903,278 |
Total finance lease cost | 198,158 | 1,086,245 |
Operating lease cost | 43,625 | 130,875 |
Total lease cost | $ 241,783 | $ 1,217,120 |
Minimum | ||
Leases | ||
Finance lease term | 12 months | 12 months |
Finance lease interest (as a percent) | 4.00% | 4.00% |
Maximum | ||
Leases | ||
Finance lease term | 36 months | 36 months |
Finance lease interest (as a percent) | 13.00% | 13.00% |
Leases - Lease balance sheet (D
Leases - Lease balance sheet (Details) | Jun. 30, 2020USD ($) |
Leases | |
Operating leases, Right-of-use asset | $ 206,229 |
Operating leases, Lease obligation | 229,979 |
Finance leases, Lease obligation | $ 90,375 |
Operating leases, Weighted-average remaining lease term | 1 month 9 days |
Finance leases, Weighted-average remaining lease term | 2 months 9 days |
Operating leases, Weighted-average discount rate (as a percent) | 9.00% |
Finance leases, Weighted-average discount rate (as a percent) | 8.10% |
Leases - Lease cashflow (Detail
Leases - Lease cashflow (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Leases | ||
Operating cash flows from finance leases | $ 903,278 | |
Operating cash flows from operating leases | 140,625 | |
Financing cash flows from finance leases | $ 196,959 | $ 470,295 |
Right-of-use assets obtained in exchange for finance lease obligations | $ 48,683 |
Leases - Lease minimum payments
Leases - Lease minimum payments (Details) | Jun. 30, 2020USD ($) |
Operating leases | |
2020 (remaining three months) | $ 46,875 |
2021 | 195,000 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
Total undiscounted lease payments | 241,875 |
Less: Imputed interest | 11,896 |
Total lease obligations | 229,979 |
Finance leases | |
2020 (remaining three months) | 19,864 |
2021 | 34,869 |
2022 | 29,605 |
2023 | 13,149 |
2024 | 4,383 |
Total undiscounted lease payments | 101,870 |
Less: Imputed interest | 11,495 |
Total lease obligations | $ 90,375 |
Leases - Prior year minimum pay
Leases - Prior year minimum payments (Details) | Sep. 30, 2019USD ($) |
Operating lease minimum payments | |
2020 | $ 187,500 |
2021 | 195,000 |
Total operating lease obligations | 382,500 |
Capital lease minimum payments | |
2020 | 1,608,067 |
2021 | 1,506,592 |
2022 | 1,535,809 |
2023 | 1,564,027 |
2024 | 1,593,291 |
Thereafter | 5,691,492 |
Total undiscounted lease payments | 13,499,278 |
Less: Imputed interest | 9,941,198 |
Total capital lease obligations | $ 3,558,080 |
Common Stock, Convertible Pre_3
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) - Common Stock (Details) | Mar. 19, 2020itemshares | Jun. 30, 2020USD ($)$ / sharesshares | Feb. 29, 2020USD ($)$ / sharesshares | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2019USD ($) | Jan. 27, 2020individual | Sep. 30, 2019USD ($) |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Sale of common stock (in shares) | 7,244,739 | ||||||
Number of warrants issued | 7,051,857 | 7,051,857 | |||||
Proceeds from issuance of common stock through private placement and public offering, net | $ | $ 34,739,271 | $ 45,964,820 | |||||
Warrants outstanding | $ | $ 181,098 | $ 181,098 | $ 255,734 | ||||
Number of principals | item | 4 | ||||||
Number of executive officers | 2 | 2 | |||||
Direct registered offering | |||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Sale of common stock (in shares) | 8,407,411 | 7,598,426 | |||||
Number of warrants issued | 588,519 | 3,799,213 | 588,519 | ||||
Proceeds from issuance of common stock through private placement and public offering, net | $ | $ 10,200,000 | ||||||
Shares issued, price per share | $ / shares | $ 1.215 | $ 1.016 | $ 1.215 | ||||
Net proceeds | $ | $ 7,700,000 | ||||||
Exercise price per share | $ / shares | $ 1.51875 | $ 1.51875 | |||||
Warrants exercise term | 5 years | 5 years | |||||
Private Placement | |||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Sale of common stock (in shares) | 16,000,000 | 2,460,630 | |||||
Number of warrants issued | 1,230,315 | ||||||
Proceeds from issuance of common stock through private placement and public offering, net | $ | $ 16,000,000 | ||||||
Shares issued, price per share | $ / shares | $ 1 | $ 1.016 | $ 1 | ||||
Net proceeds | $ | $ 2,500,000 | ||||||
Exercise price per share | $ / shares | $ 0.9535 | ||||||
Warrants exercise term | 4 years | ||||||
Placement Agent | |||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||
Number of warrants issued | 531,890 | ||||||
Exercise price per share | $ / shares | $ 1.27 | ||||||
Warrants exercise term | 5 years |
Common Stock, Convertible Pre_4
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) - Stock (Details) - USD ($) | Mar. 23, 2020 | Mar. 19, 2020 | Jun. 30, 2020 | Feb. 29, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Mar. 22, 2020 | Jan. 27, 2020 | Dec. 23, 2019 | Sep. 30, 2019 | Apr. 12, 2019 |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||||
Number of share issued | 7,244,739 | ||||||||||
Issuance of vested restricted stock units (in shares) | 109 | 446 | |||||||||
Deemed dividend upon amendment of the terms of the Series A-1 convertible preferred stock | $ 10,328,118 | ||||||||||
Series A convertible preferred stock | |||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||||
Convertible preferred stock, shares authorized | 1,000,000 | 1,000,000 | 1,000,000 | ||||||||
Convertible preferred stock outstanding | 0 | 0 | 0 | ||||||||
Series A-1 convertible preferred stock | |||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||||
Number of share issued | 29,358,621 | ||||||||||
Convertible preferred stock, shares authorized | 200,000 | 200,000 | 200,000 | ||||||||
Shares issued, price per share | $ 100 | $ 100 | |||||||||
Dividend rate | 10.00% | ||||||||||
Number of Series A convertible stock converted | 68,112 | ||||||||||
Debt Instrument, Convertible, Conversion Price | $ 431.03447263 | $ 18.89797 | |||||||||
Deemed dividend upon amendment of the terms of the Series A-1 convertible preferred stock | $ 10,328,118 | ||||||||||
Convertible preferred stock outstanding | 0 | 0 | 66,451 | ||||||||
Preferred stock issued to settle dividends (in shares) | 1,661 | 4,628 | |||||||||
Warrant | |||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||||
Number of share issued | 13,003,414 | ||||||||||
Exercise price per share | $ 0.232 | $ 0.232 | $ 0.232 | $ 0.232 | $ 0.2320 | $ 2.90 | |||||
Private Placement | |||||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||||
Number of share issued | 16,000,000 | 2,460,630 | |||||||||
Shares issued, price per share | $ 1 | $ 1.016 | $ 1 | ||||||||
Exercise price per share | $ 0.9535 |
Common Stock, Convertible Pre_5
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) - Warrants summary (Details) | Jun. 30, 2020$ / sharesshares |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 7,051,857 |
February 18, 2022 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 416,666 |
Exercise price per share | $ / shares | $ 12 |
December 22, 2024 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 277,128 |
Exercise price per share | $ / shares | $ 12 |
April 13, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 145,688 |
Exercise price per share | $ / shares | $ 12 |
May 31, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 62,438 |
Exercise price per share | $ / shares | $ 12 |
February 24, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 531,890 |
Exercise price per share | $ / shares | $ 1.27 |
February 26, 2024 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 5,029,528 |
Exercise price per share | $ / shares | $ 0.9535 |
June 22, 2025 | |
Class of Warrant or Right [Line Items] | |
Shares of common stock issuable upon exercise of warrants | 588,519 |
Exercise price per share | $ / shares | $ 1.5188 |
Common Stock, Convertible Pre_6
Common Stock, Convertible Preferred Stock and Stockholders' Equity (Deficit) - Warrants (Details) - USD ($) | Mar. 19, 2020 | Jan. 27, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Mar. 23, 2020 | Dec. 23, 2019 | Apr. 12, 2019 |
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||
Shares of common stock issuable upon exercise of warrants | 7,051,857 | 7,051,857 | |||||||
Deemed dividend upon modification of warrants | $ 3,140,009 | $ 829,530 | |||||||
Number of share issued | 7,244,739 | ||||||||
Common stock repurchase note | |||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||
Number of share issued | 24,407,411 | 10,340,000 | 34,466,467 | 10,340,000 | |||||
Warrant | |||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||
Exercise price per share | $ 0.232 | $ 0.232 | $ 0.232 | $ 0.232 | $ 0.2320 | $ 2.90 | |||
Shares of common stock issuable upon exercise of warrants | 4,657,852 | 15,085,240 | 15,085,240 | ||||||
Net proceeds | $ 1,100,000 | ||||||||
Number of share issued | 13,003,414 | ||||||||
Warrant expired (in shares) | 80,797 | 80,797 | |||||||
Warrants expired (in dollars per share) | $ 0.08 | $ 0.08 | |||||||
Warrant, 15 Months | |||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||
Warrants exercise term | 15 months | ||||||||
Shares of common stock issuable upon exercise of warrants | 10,157,050 | 10,157,050 | |||||||
Warrant, 5 Years | |||||||||
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items] | |||||||||
Warrants exercise term | 5 years |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional information (Details) | 9 Months Ended |
Jun. 30, 2020shares | |
Performance-based stock units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Term of award | 10 years |
2011 Equity Incentive Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares of common stock reserved for issuance | 106,490 |
2011 Equity Incentive Plan | Performance-based stock units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Awards outstanding | 2,470 |
2015 Equity Incentive Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Aggregate number of common stock authorized for issuance | 4,022,526 |
Number of shares available for grant | 1,614,404 |
Term of award | 10 years |
2015 Equity Incentive Plan | Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 1 year |
2015 Equity Incentive Plan | Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 4 years |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,358,720 | $ (31,265) | $ 2,022,736 | $ 1,108,766 |
Accrued directors' fees settled in fully vested stock options | 49,121 | 49,121 | ||
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 915,974 | (207,015) | 1,064,912 | 4,957 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 442,746 | $ 175,750 | $ 957,824 | $ 1,103,809 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) - USD ($) | 9 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Number of Shares | ||
Balance, Beginning | 1,389,999 | |
Granted | 1,115,810 | |
Forfeited | (267,339) | |
Balance, Ending | 2,238,470 | |
Vested and exercisable | 551,799 | |
Vested and expected to vest | 2,238,470 | |
Weighted Average Exercise Price | ||
Balance, Beginning | $ 3.46 | |
Granted | 1 | |
Forfeited | 2.74 | |
Balance, Ending | 2.32 | |
Vested and exercisable | 3.34 | |
Vested and expected to vest | $ 2.32 | |
Other option information | ||
Balance | 9 years 2 months 12 days | |
Vested and exercisable | 8 years 10 months 24 days | |
Vested and expected to vest | 9 years 2 months 12 days | |
Aggregate intrinsic value | $ 388,541 | |
Weighted average grant date fair value of the options awarded to employees | $ 0.71 | $ 4.70 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Assumptions (Details) - Stock options - USD ($) | 9 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.08% | 2.46% |
Expected life (years) | 5 years 8 months 23 days | 6 years |
Expected volatility | 89.30% | 89.50% |
Expected dividend yield | 0.00% | 0.00% |
Unrecognized compensation expense | $ 2,110,777 | |
Weighted average exercise period of unrecognized compensation | 2 years 8 months 19 days |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance-Based (Details) - Performance-based stock units | 9 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Term of award | 10 years |
Number of PSUs | |
Balance, Beginning | shares | 15,691 |
Forfeitures | shares | 13,221 |
Balance, Ending | shares | 2,470 |
Vested and exercisable | shares | 2,470 |
Vested and expected to vest | shares | 2,470 |
Weighted Average Base Price Per Unit | |
Balance, Beginning | $ / shares | $ 49.97 |
Forfeitures | $ / shares | 50.60 |
Balance, Ending | $ / shares | 49.97 |
Vested and exercisable | $ / shares | 49.97 |
Vested and expected to vest | $ / shares | $ 49.97 |
Weighted average remaining contractual term, Outstanding | 4 years |
Weighted average remaining contractual term, Vested and exercisable | 4 years |
Weighted average remaining contractual term, Vested and expected to vest | 4 years |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted stock units (Details) - Restricted stock units | 9 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Number of RSUs | |
Balance, Beginning | shares | 109 |
Vested and settled | shares | (109) |
Balance, Ending | shares | 0 |
Weighted Average Grant Date Fair Value | |
Balance, Beginning | $ / shares | $ 96 |
Vested and settled | $ / shares | 96 |
Balance, Ending | $ / shares | $ 0 |
Stock-Based Compensation - Re_2
Stock-Based Compensation - Restricted stock (Details) | Mar. 19, 2020itemshares | Jan. 27, 2020item$ / sharesshares | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of principals | item | 4 | |||||
Number of share issued | shares | 7,244,739 | |||||
Stock-based compensation expense | $ | $ 1,358,720 | $ (31,265) | $ 2,022,736 | $ 1,108,766 | ||
MTTR, LLC (“MTTR”) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of principals | item | 4 | |||||
Number of share issued | shares | 7,244,739 | |||||
Restricted Stock | MTTR, LLC (“MTTR”) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of principals | item | 4 | |||||
Number of share issued | shares | 7,244,739 | |||||
Term following the FDA approval | 6 months | |||||
Share repurchase price | $ / shares | $ 0.01 | |||||
Grant date fair value of share | $ / shares | $ 0.54 | |||||
Explicit service period | 4 years 9 months 18 days | |||||
Stock-based compensation expense | $ | 1,070,404 | 1,149,387 | ||||
Unamortized expense to be recognized of stock awards other than options | $ | $ 2,762,772 | $ 2,762,772 | ||||
Restricted Stock | MTTR, LLC (“MTTR”) | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Repurchase right lapses on shares (as a percent) | 50.00% | |||||
Restricted Stock | MTTR, LLC (“MTTR”) | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Repurchase right lapses on shares (as a percent) | 100.00% |
Related-Party Transactions (Det
Related-Party Transactions (Details) | Mar. 19, 2020itemshares | Jan. 27, 2020USD ($)itemindividualshares | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Sep. 30, 2019USD ($) |
Related Party Transaction [Line Items] | |||||||
Number of principals | item | 4 | ||||||
Number Of Executive Officers | 2 | 2 | |||||
Shares issued during period | shares | 7,244,739 | ||||||
MTTR, LLC (“MTTR”) | |||||||
Related Party Transaction [Line Items] | |||||||
Number of principals | item | 4 | ||||||
Shares issued during period | shares | 7,244,739 | ||||||
Contract termination settlement fee | $ 110,000 | ||||||
Related party expense | $ 242,603 | $ 573,983 | $ 1,023,374 | $ 1,154,894 | |||
Due to related party, current | $ 89,762 | $ 89,762 | $ 365,301 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) | Jul. 20, 2020 | Jul. 16, 2020 | Mar. 19, 2020 | Jul. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 |
Subsequent Event | ||||||
Proceeds from the sale of common stock, net of offering costs | $ 34,739,271 | $ 45,964,820 | ||||
Number of share issued | 7,244,739 | |||||
Granted | 1,115,810 | |||||
Weighted average exercise price | $ 1 | |||||
Weighted average grant date fair value | $ 0.71 | $ 4.70 | ||||
Subsequent Event | ||||||
Subsequent Event | ||||||
Proceeds from the sale of common stock, net of offering costs | $ 1,000,000 | |||||
Number of share issued | 823,045 | |||||
Shares issued, price per share | $ 1.215 | |||||
Granted | 1,581,256 | |||||
Weighted average exercise price | $ 1.57 | |||||
Weighted average grant date fair value | $ 1.14 | |||||
Loss contingency damages due value | $ 3,000,000 |