Outlook Therapeutics (OTLK) 10-K 23 Dec 20 2020 FY Annual report Financial data

Document And Entity Information

Document And Entity Information - USD ($) $ in Millions	12 Months Ended
	Sep. 30, 2020	Dec. 18, 2020	Mar. 31, 2020
Document Information [Line Items]
Document Type	10-K
Document Period End Date	Sep. 30, 2020
Entity Registrant Name	Outlook Therapeutics, Inc.
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
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 Public Float			$ 20.4
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	FY
Amendment Flag	false
Common Stock
Document Information [Line Items]
Title of 12(b) Security	Common Stock
Trading Symbol	OTLK
Security Exchange Name	NASDAQ
Series A Warrants
Document Information [Line Items]
Title of 12(b) Security	Series A Warrants
Trading Symbol	OTLKW
Security Exchange Name	NASDAQ

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Current assets:
Cash	$ 12,535,986	$ 8,015,528
Prepaid expenses and other current assets	5,407,882	4,986,033
Assets held for sale		500,000
Total current assets	17,943,868	13,501,561
Property and equipment, net	327,249	3,175,960
Operating lease right-of-use assets, net	166,986
Other assets	1,294,448	457,476
Total assets	19,732,551	17,134,997
Current liabilities:
Convertible senior secured notes		6,699,000
Current portion of long-term debt	50,285	1,026,168
Current portion of finance lease liabilities	29,778	192,290
Current portion of operating lease liabilities	187,486
Stockholder notes	3,612,500	3,612,500
Accounts payable	2,394,818	2,277,817
Accrued expenses	7,757,310	4,622,988
Income taxes payable	1,856,629	1,859,434
Total current liabilities	15,888,806	20,290,197
Long-term debt	904,200	50,285
Finance lease liabilities	42,482	3,365,790
Warrant liability	70,772	255,734
Other liabilities		3,942,948
Total liabilities	16,906,260	27,904,954
Commitments and contingencies (Note 10)
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; 127,183,109 and 28,609,995 shares issued and outstanding at September 30, 2020 and 2019, respectively	1,271,831	286,100
Additional paid-in capital	291,274,366	238,064,947
Accumulated deficit	(289,719,906)	(254,480,408)
Total stockholders' equity (deficit)	2,826,291	(16,129,361)
Total liabilities, convertible preferred stock and stockholders' equity (deficit)	19,732,551	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	Sep. 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	127,183,109	28,609,995
Common stock, shares outstanding	127,183,109	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
Preferred stock shares outstanding	0	0

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Consolidated Statements of Operations
Collaboration revenues		$ 8,146,123
Operating expenses:
Research and development	$ 26,341,998	23,805,251
General and administrative	9,971,015	9,369,823
Impairment of property and equipment	527,624	11,270,110
Total operating expenses	36,840,637	44,445,184
Loss from operations	(36,840,637)	(36,299,061)
Interest expense, net	1,756,471	3,466,688
Loss on extinguishment of debt	1,896,296	607,240
Change in fair value of redemption feature	(1,796,982)
Change in fair value of warrant liability	(184,962)	(2,438,201)
Loss before income taxes	(38,511,460)	(37,934,788)
Income tax benefit	(3,271,962)	(3,411,001)
Net loss	(35,239,498)	(34,523,787)
Beneficial conversion feature upon issuance of Series A-1 convertible preferred stock		(61,365)
Series A-1 convertible preferred stock dividends and related settlement	(166,133)	(624,988)
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	$ (48,873,758)	$ (36,039,670)
Per share information:
Net loss per share of common stock, basic and diluted (in dollars per share)	$ (0.67)	$ (1.98)
Weighted average shares outstanding, basic and diluted (in shares)	72,555,636	18,191,827

Consolidated Statements of Conv

Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($)	Preferred StockSeries A-1 convertible preferred stock	Common StockMTTR, LLC (“MTTR”)	Common Stock	Additional Paid-in CapitalMTTR, LLC (“MTTR”)	Additional Paid-in Capital	Accumulated DeficitPeriod of Adoption, Adjustment	Accumulated Deficit	Series A-1 convertible preferred stock	Period of Adoption, Adjustment	Total
Balance at Sep. 30, 2018	$ 4,734,416		$ 90,275		$ 190,672,166	$ (3,649,258)	$ (216,307,363)		$ (3,649,258)	$ (25,544,922)
Balance, beginning (in shares) at Sep. 30, 2018	60,203		9,027,491
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with exercise of warrants			$ 61,348		(56,998)					$ 4,350
Issuance of common stock in connection with exercise of warrants (in shares)			6,134,763							10,273,558
Sale of common stock			$ 103,400		26,053,103					$ 26,156,503
Sale of common stock, net of issuance costs (in shares)			10,340,000							6,134,763
Private placement sale of common stock and common stock warrants, net of costs			$ 26,804		19,781,514					$ 19,808,318
Private placement sale of common stock and common stock warrants, net of costs (in shares)			2,680,390
Issuance of vested restricted stock units			$ 41		(41)
Issuance of vested restricted stock units (in shares)			4,069							4,069
Issuance of common stock in connection with conversion of senior secured notes			$ 503		401,464					$ 401,967
Issuance of common stock in connection with conversion of senior secured notes (in shares)			50,394
Issuance of common stock in connection with conversion of stockholder notes			$ 3,729		476,271					480,000
Issuance of common stock in connection with conversion of stockholder notes (in shares)			372,888
Series A-1 convertible preferred stock dividends and related settlement	$ 624,988				(624,988)					(624,988)
Series A-1 convertible preferred stock dividends and related settlement (in shares)	6,248							6,248
Stock-based compensation expense					1,313,335					1,313,335
Accrued directors fees settled in fully vested stock options					49,121					49,121
Net loss							(34,523,787)			(34,523,787)
Balance at Sep. 30, 2019	$ 5,359,404		$ 286,100		238,064,947		(254,480,408)			(16,129,361)
Balance, ending (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							15,085,240
Sale of common stock			$ 352,895		34,993,602					$ 35,346,497
Sale of common stock, net of issuance costs (in shares)			35,289,512							13,003,414
Issuance of vested restricted stock units		$ 72,447	$ 1	$ (72,447)	(1)
Issuance of vested restricted stock units (in shares)		7,244,739	109							109
Issuance of common stock in connection with conversion of senior secured notes			$ 122,015		7,872,479					$ 7,994,494
Issuance of common stock in connection with conversion of senior secured notes (in shares)			12,201,461
Issuance of common stock in connection with conversion of stockholder notes			$ 14,753		1,533,673					1,548,426
Issuance of common stock in connection with conversion of stockholder notes (in shares)			1,475,258
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					2,807,429					2,807,429
Conversion of Series A convertible preferred stock to common stock	$ (5,525,537)		$ 293,586		5,231,951					5,525,537
Conversion of Series A convertible preferred stock to common stock (in shares)	(68,112)		29,358,621
Net loss							(35,239,498)			(35,239,498)
Balance at Sep. 30, 2020			$ 1,271,831		$ 291,274,366		$ (289,719,906)			$ 2,826,291
Balance, ending (in shares) at Sep. 30, 2020			127,183,109

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
OPERATING ACTIVITIES
Net loss	$ (35,239,498)	$ (34,523,787)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	554,069	3,361,873
Loss on extinguishment of debt	1,896,296	607,240
Non-cash interest expense	235,636	1,314,321
Stock-based compensation	2,807,429	1,313,335
Change in fair value of redemption feature	(1,796,982)
Change in fair value of warrant liability	(184,962)	(2,438,201)
Impairment of property and equipment	527,624	11,270,110
Loss on lease termination	680,017
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(310,270)	(3,245,146)
Other assets	(84,120)	(87,182)
Operating lease liability	(164,686)
Accounts payable	(1,489,760)	(1,331,640)
Accrued expenses	726,332	(482,665)
Income taxes payable	(2,805)	3,305
Deferred revenue		(8,146,123)
Other liabilities	55,587	94,572
Net cash used in operating activities	(31,790,093)	(32,289,988)
INVESTING ACTIVITIES
Purchase of property and equipment		(437,307)
Investment in joint venture	(900,000)
Net cash used in investing activities	(900,000)	(437,307)
FINANCING ACTIVITIES
Proceeds from the sale of common stock, net of offering costs	35,430,727	45,964,821
Proceeds from debt	904,200
Proceeds from exercise of common stock warrants	1,138,900	4,350
Payments of finance lease obligations	(215,074)	(526,087)
Repayment of debt	(48,202)	(6,417,652)
Net cash provided by financing activities	37,210,551	39,025,432
Net increase in cash	4,520,458	6,298,137
Cash at beginning of year	8,015,528	1,717,391
Cash at end of year	12,535,986	8,015,528
Supplemental disclosure of cash flow information
Cash paid for interest	913,967	2,794,572
Accrued interest settled by conversion into common stock	1,531,004	1,393
Supplemental schedule of non-cash financing activities:
Senior secured notes principal converted into common stock	7,033,950	400,574
Unsecured notes principal converted into common stock	977,966	480,000
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	624,988
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses	$ 84,230
Accrued directors' fees settled in fully vested stock options		$ 49,121

Organization and Operations

Organization and Operations	12 Months Ended
	Sep. 30, 2020
Organization and Operations
Organization and Operations	1. Organization and Operations Description of the Business Outlook Therapeutics, Inc., (formerly Oncobiologics, Inc.), ("Outlook" or the "Company") was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc." in November 2018. The Company is a late clinical-stage biopharmaceutical company focused on developing and commercializing ONS‑5010, 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 NORSE ONE, NORSE TWO and NORSE THREE, the Company’s 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 year ended September 30, 2020 were not significantly impacted by COVID-19.

Liquidity

Liquidity	12 Months Ended
	Sep. 30, 2020
Liquidity
Liquidity	2. Liquidity The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $289.7 million as of September 30, 2020, which raises substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. On November 5, 2020, the Company received $10.0 million in net proceeds from issuance of an unsecured promissory note with face amount of $10.2 million. The note bears interest at a rate of 7.5% per annum, matures January 1, 2022, and includes an original issue discount of $0.2 million. The Company may prepay all or a portion of the note at any time by paying 105% of the outstanding balance elected for pre-payment. In November 2020, the Company repaid $3.6 million of unsecured stockholder notes that were due on demand as of September 30, 2020. Management believes that the Company’s existing cash as of September 30, 2020 together with the $10.0 million in proceeds from the unsecured promissory note issued in November 2020, after taking into account repayment of $3.6 million of debt, is expected to fund its operations into March 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	12 Months Ended
	Sep. 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 consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statement of operations as they occur. Use of estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary. Fair value of financial instruments 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. At September 30, 2020 and 2019, the Company’s financial instruments included cash, accounts payable, accrued expenses, equipment loans, stockholder notes and the Paycheck Protection Program (the “PPP”) loan under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The carrying amount of accounts payable, accrued expenses, equipment loans, and stockholder notes approximates fair value due to the short-term maturities of these instruments. Fair Value of Other Financial Instruments As of September 30, 2020, the fair value and carrying value of the PPP loan included in long-term debt on the consolidated balance sheets was $837,000 and $904,200, respectively. The estimated fair value for the Company’s PPP loan was based on discounted expected future cash flows using prevailing interest rates which are Level 3 inputs under the fair value hierarchy. Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the term of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations. Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. The Company recognized an impairment charge of $0.5 million and $11.3 million during the years ended September 30, 2020 and 2019, respectively, which is described more fully in Note 5. Leases 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 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. 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 10 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 September 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 incurred 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. Stock-based compensation The Company measures equity classified stock-based awards based on the estimated fair value on the date of grant and recognizes compensation expense of those awards on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The Company accounts for forfeitures of stock option awards as they occur. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in Note 13. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant. Revenue recognition On October 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) and changed its revenue recognition policies accordingly. The standard’s stated core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about: · Contracts with customers – including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations). · Significant judgments and changes in judgments – determining the timing of satisfaction of performance obligations (over time or at a point in time) and determining the transaction price and amounts allocated to performance obligations. · Certain assets  – assets recognized from the costs to obtain or fulfill a contract. The Company’s revenue is generated primarily through collaboration research and license agreements. The terms of these agreements generally contain multiple deliverables which may include (i) licenses, (ii) research and development activities, (iii) clinical manufacturing and, (iv) product supply. The payment terms of these agreements may include nonrefundable upfront fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. The Company typically receives upfront, nonrefundable payments when licensing its intellectual property. The Company’s arrangements fall under ASC 808, Collaborations (“ASC 808”). ASC 808 does not address recognition or measurement matters but prescribes that entities look to other GAAP by analogy, namely ASU 2014-09. As such, the Company completed an analysis of existing contracts with the Company’s collaboration partners and assessed the differences in accounting for such contracts under ASU 2014-09 compared with current revenue accounting standards. Under the ASU 2014-09, the Company treats substantive milestones as forms of variable consideration which is recognized over the estimated performance period. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. The Company adopted the new accounting standard utilizing the modified retrospective method and, therefore, no adjustments were made to amounts in its prior period financial statements. The Company recorded the cumulative effect of adopting the standard as an adjustment to increase accumulated deficit by $3.6 million. During the fiscal year ended September 30, 2020, the Company would have recognized $4.5 million of collaboration revenues under revenue recognition guidance in effect during fiscal 2018 prior to the adoption of ASU 2014-09. Incentive and tax receivables The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable period. The Company’s estimate of the amount of cash refund it expects to receive related to the Australian research and development tax incentive program is included in prepaid expenses and other current assets in the accompanying consolidated balance sheets. As of September 30, 2020, the Company’s estimate of the amount of cash refund it expects to receive in 2021 for 2020 eligible spending as part of this incentive program was $0.8 million. As of September 30, 2019, the Company had a receivable of $1.1 million which was received in 2020 as part of this incentive program. In addition, the Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in prepaid expenses and other current assets in the accompanying consolidated balance sheet. As of September 30, 2019, prepaid expenses and other current assets included $0.1 million for refundable GST on expenses incurred with Australian vendors. Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the years ended September 30, 2020 and 2019, the Company recorded $0.5 million and $1.2 million, respectively, in its consolidated statements of operations related to the cash refund it expected to receive from the Australian research and development tax incentive program. Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Net loss per share Basic net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock 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 potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2020 and 2019, as they would be antidilutive: As of September 30, 2020 2019 Series A-1 convertible preferred stock — 1,255,789 Convertible senior secured notes — 767,605 Convertible unsecured notes — 149,573 Performance-based stock units 2,470 15,691 Restricted stock units — 109 Stock options 3,762,143 1,389,999 Common stock warrants 7,051,854 16,067,948 Recently issued accounting pronouncements 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 into 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.

Fair Value Measurements

Fair Value Measurements	12 Months Ended
	Sep. 30, 2020
Fair Value Measurements
Fair Value Measurements	4. Fair Value Measurements The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis: September 30, 2020 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 70,772 September 30, 2019 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 255,734 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 years ended September 30, 2020 and 2019: Redemption Warrants Feature Balance at October 1, 2019 $ 255,734 $ — Addition of feature on December 20, 2019 — 8,264,451 Change in fair value (184,962) (1,796,982) Write off due to extinguishment of senior secured notes — (6,467,469) Balance at September 30, 2020 $ 70,772 $ — The warrants issued in connection with the convertible senior secured notes (see Note 9) are classified as liabilities on the accompanying consolidated balance sheets 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: September 30, 2020 2019 Risk-free interest rate 0.24 % 1.56 % Remaining contractual life of warrant 4.38 years 5.38 years Expected volatility 94.7 % 89.0 % Annual dividend yield 0 % 0 % Fair value of common stock $ 0.72 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

Property and Equipment	12 Months Ended
	Sep. 30, 2020
Property and Equipment
Property and Equipment	5. Property and Equipment Property and equipment, net, consists of: 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 (740,102) (1,051,477) $ 327,249 $ 3,175,960 Depreciation and amortization expense for the years ended September 30, 2020 and 2019 was $219,416 and $3,361,873, 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 10 for the Company’s lease disclosures. At September 30, 2019, the Company’s corporate office was classified as a capital lease and had a gross carrying amount of $3,000,000 and accumulated amortization of $475,000. Impairment Charge During the year ended September 30, 2020, the Company recorded an impairment charge of $527,624 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 10 for further details. In the fourth quarter of fiscal year 2019, as a result of management’s decision to outsource the commercial manufacturing and remaining development for the Company’s ONS-5010 program, the Company decided to vacate and sublease the Company’s manufacturing and corporate offices and sell or transfer excess laboratory and related computer equipment no longer required for the development of the Company’s ONS-5010 program. These events qualified as indicators of impairment in accordance with ASC 360, Property, Plant and Equipment (“ASC 360”) and required an impairment analysis. As a result of the analysis, management determined that the Company’s long-lived assets with a carrying amount of $13,032,320 were no longer recoverable and were impaired and wrote the assets down to their estimated fair value of $3,676,008. The estimated fair value for the Company’s land and building and leasehold improvement assets was based on discounted expected future cash flows using Level 3 inputs under ASC 820, Fair Value Measurements (“ASC 820”). The estimated fair value for the Company’s laboratory and related computer equipment was based on offers the Company received from unrelated third parties to purchase the assets which is classified as a Level 3 measurement under ASC 820’s fair value hierarchy. Management determined that $500,000 of laboratory equipment met the definition of “held for sale” under ASC 360 as it was probable that a sale of the laboratory equipment could be completed within one year as of September 30, 2019. The Company recorded an impairment charge totaling $11,270,110 for the year ended September 30, 2019 in the consolidated statements of operations associated with the above items.

Other Assets

Other Assets	12 Months Ended
	Sep. 30, 2020
Other Assets
Other Assets	6. Other Assets Other assets consist of: September 30, 2020 2019 Advance to PRC joint venture (see Note 14) $ 900,000 $ — Other assets 394,448 457,476 $ 1,294,448 $ 457,476 In June 2020, the Company issued 16,000,000 shares of common stock to Syntone Ventures LLC, or Syntone, a U.S. affiliate of Syntone Technologies Group Co. Ltd., a People's Republic of China, or PRC, entity, its strategic partner for ONS-5010 in China, pursuant to a stock purchase agreement entered in May 2020, at a purchase price of $1.00 per share, receiving aggregate gross proceeds of $16.0 million (see Note 11).

Accrued Expenses

Accrued Expenses	12 Months Ended
	Sep. 30, 2020
Accrued Expenses
Accrued Expenses	7 . Accrued Expenses Accrued expenses consists of: September 30, 2020 2019 Compensation $ 579,618 $ 919,394 Severance and related costs 9,521 505,570 Research and development 2,890,333 1,692,040 Interest payable 3,691 934,145 Professional fees 132,085 419,216 Lease termination obligation 3,971,111 — Other accrued expenses 170,951 152,623 $ 7,757,310 $ 4,622,988

Stockholder Notes

Stockholder Notes	12 Months Ended
	Sep. 30, 2020
Stockholder Notes
Stockholder Notes	8 . Stockholder Notes September 30, 2020 2019 Restricted stock repurchase notes $ 800,000 $ 800,000 Common stock repurchase note 2,812,500 2,812,500 3,612,500 3,612,500 Less: current portion (3,612,500) (3,612,500) $ — $ — The Company previously repurchased shares of its restricted stock in exchange for notes totaling $800,000 that bore interest at rates ranging from 0% to 4% per annum and were due on demand. These notes were paid in full in November 2020. The Company had a $2,812,500 note payable related to the previous repurchase of common stock that did not bear interest and was due on demand. This note was paid in full in November 2020. The Company also borrowed from stockholders for working capital purposes and had two unsecured stockholder notes having an original aggregate principal amount of $1,000,000 and which bore interest from 0% to 30% per annum. These notes were purchased in March 2019 by Iliad Research and Trading, L.P., a Utah limited partnership, (the “Lender”) from the former stockholders, and subsequently converted to common stock and are no longer outstanding. Refer to Note 9 for the details on the purchase agreement. During the year ended September 30, 2019, the Company recognized interest expense related to the stockholder notes of $105,357.

Debt

Debt	12 Months Ended
	Sep. 30, 2020
Debt
Debt	9. Debt Senior secured notes September 30, 2020 2019 Convertible senior secured notes $ — $ 6,699,000 In November 2018, the Company reached an agreement with the holders of its $13.5 million senior secured notes to extend the maturity of the senior secured notes until December 22, 2019, in exchange for making several payments of principal and interest during 2019, as well as subject to meeting additional capital raising commitments that the Company met in April 2019 through the completed public offering. In addition, the Company agreed to make the senior secured notes convertible into common stock at a price of $8.9539 per share and reduced the exercise price of warrants to purchase 485,245 shares of common stock held by the senior secured noteholders from $24.00 per share to $12.00 per share. The increase in the fair value of the warrants of $1.5 million due to the modification was recorded as additional debt discount and amortized over the remaining term of the senior secured notes using the effective interest rate method. The total amortization of the debt discount for the years ended September 30, 2020 and 2019 was $235,636 and $1,314,321, respectively. During the year ended September 30, 2019, convertible senior secured notes with a carrying amount of $400,575 and accrued interest of $1,393 were converted into 50,394 shares of the Company’s common stock. During the year ended September 30, 2019, the Company repaid a total of $6.4 million of principal and $1.3 million of accrued interest on such notes. In June 2019, the Company entered into a Third Note Amendment (the “Third Amendment”) with the holders of the remaining $6.7 million outstanding aggregate principal amount of senior secured notes. Under the Third Amendment, the maturity date of the convertible senior secured notes was amended to December 22, 2019 and eliminated the scheduled payments of certain principal and interest payments on or prior to December 22, 2019. The Company also agreed to increase the interest rate payable on such convertible senior secured notes to 12.0% per annum from 5.0% per annum. The Third Amendment was accounted for as an extinguishment of debt. Loss on extinguishment of convertible senior secured notes recognized during the year ended September 30, 2019 was $423,686. 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 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 year ended September 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 September 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 year ended September 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 years ended September 30, 2020 and 2019 was $819,498 and $1,892,155, respectively. Other indebtedness The Company has other outstanding debt consisting of unsecured notes, a PPP term loan and equipment loans. Refer to Note 8 for additional information on unsecured notes (working capital notes). September 30, 2020 2019 Unsecured notes $ — $ 977,966 Paycheck Protection Program term loan 904,200 — Equipment loans 50,285 98,487 954,485 1,076,453 Less: current portion (50,285) (1,026,168) Long-term debt $ 904,200 $ 50,285 Unsecured notes On March 7, 2019, the Company entered into a forbearance and exchange agreement with 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 year ended September 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 September 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 October 15, 2021, 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 October 15, 2021 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. Equipment loans The equipment loans bear interest at rates ranging from 12% to 16% with the original term of the loans ranging from one to five years. Minimum monthly payments of principal and interest under the equipment loans are collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and former chief executive officer. Interest expense on other indebtedness for the years ended September 30, 2020 and 2019 was $25,628 and $83,963, respectively. Future maturities of other indebtedness at September 30, 2020 are as follows for the years ending September 30: 2021 $ 50,285 2022 904,200 $ 954,485

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Sep. 30, 2020
Commitments
Commitments	10. Commitments and Contingencies Selexis Commercial License Agreements In April 2013, the Company entered into commercial license agreements with Selexis for each of the ONS‑3010, ONS‑1045 and ONS‑1050 biosimilar product candidates (which agreements were subsequently amended on May 21, 2014). Under the terms of each commercial license agreement, the Company acquired a non-exclusive worldwide license under the Selexis Technology to use the applicable Selexis expression technology along with the resulting Selexis materials/cell lines, each developed under the research license, to manufacture and commercialize licensed and final products, with a limited right to sublicense. The Company paid an upfront licensing fee to Selexis for each commercial license and also agreed to pay a fixed milestone payment for each licensed product. In addition, the Company is required to pay a low single-digit royalty on a final product-by-final product and country-by-country basis, based on worldwide net sales of such final products by the Company or any of the Company’s affiliates or sublicensees during the royalty term. The royalty term for each final product in each country is the period commencing from the first commercial sale of the applicable final product in the applicable country and ending on the expiration of the specified patent coverage. At any time during the term, the Company has the right to terminate its royalty payment obligation by providing written notice to Selexis and paying Selexis a royalty termination fee. Each of the Company’s commercial agreements with Selexis will expire upon the expiration of all applicable Selexis patent rights. Either party may terminate the related agreement in the event of an uncured material breach by the other party or in the event the other party becomes subject to specified bankruptcy, winding up or similar circumstances. Either party may also terminate the related agreement under designated circumstances if the Selexis Technology infringes third-party intellectual property rights. In addition, the Company has the right to terminate each of the commercial agreements at any time at its convenience; however, with respect to the agreements relating to ONS‑3010 and ONS‑1045, this right is subject to the licensee’s consent pursuant to a corresponding letter the Company executed in conjunction with the standby agreement entered into between Selexis and Laboratories Liomont, S.A. de C.V. (“Liomont”) in November 2014. The standby agreement permits Liomont to assume the license under the applicable commercial agreement for Mexico upon specified triggering events involving the Company’s bankruptcy, insolvency or similar circumstances. Technology license The Company entered into a technology license agreement with Selexis that will require milestone payments of $381,174 (based on an exchange rate on September 30, 2020 for converting Swiss Francs to U.S. dollars) to the licensor by the Company upon achievement of certain clinical milestones and pay a single digit royalty on net sales by the Company utilizing such technology. The Company also has the contractual right to buy out the royalty payments at a future date. Litigation On July 20, 2020, 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 in damages due. The Company disputes the claims in the Liomont complaint, believes they are without merit, and intends to defend against these claims vigorously. Leases Prior to October 1, 2019, the Company accounted for leases under ASC 840, Accounting for Leases . Effective October 1, 2019, the Company adopted the guidance of ASC 842, Leases , which requires an entity to recognize a right-of-use asset and a lease liability for virtually all leases. The implementation of ASC 842 did not have a material impact on the Company’s consolidated financial statements and did not have a significant impact on the Company’s liquidity. The Company adopted ASC 842 using a modified retrospective approach. As a result, the comparative financial information for fiscal year 2019 has not been updated and the required disclosures prior to the date of adoption have not been updated and continue to be reported under the accounting standards in effect for that period. 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. In consideration for the termination of the Cranbury lease, the Company agreed to make payments to the landlord totaling $981,987, payable in eight monthly installments commencing May 1, 2020. The Company’s Monmouth Junction, New Jersey lease matures in September 2021. 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 September 30, 2020, the lease termination obligation of $356,987 is included in accounts payable on the consolidated balance sheets. A rollforward of the charges incurred to general and administrative expense for the year ended September 30, 2020: Balance Expensed / Accrued Cash Non-cash Balance October 1, 2019 Expense Payments Adjustments September 30, 2020 Lease termination payments $ — $ 981,987 $ (625,000) $ — $ 356,987 Assets and liabilities derecognition — (842,514) — 842,514 — Other charges — 540,544 (540,544) — — $ — $ 680,017 $ (1,165,544) $ 842,514 $ 356,987 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 office and laboratory space in Cranbury, New Jersey which was due to expire in March 2026. In consideration for the termination of the lease, the Company agreed to make payments to the landlord totaling up to $5.8 million, which includes (i) $287,615 upon execution of the termination agreement, (ii) $50,000 per month for up to 30 months, commencing September 1, 2018, and (iii) a $4.0 million payment, in any event, on or before February 1, 2021. The Company and landlord agreed that the $174,250 security deposit will be used to pay the 7 t h , 8 th , 9 th and a portion of the 10 th 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. In connection with the lease termination, the Company recorded a $4.2 million liability at September 1, 2018, the cease-use date that represents the present value of the future termination payments. The Company derecognized the assets and liabilities associated with the financing lease and recorded a lease termination charge of $4.2 million to general and administrative expense for the year ended September 30, 2018. At September 30, 2020, the lease termination obligation is included in accrued expenses and in other liabilities at September 30, 2019 on the consolidated balance sheets. A rollforward of the charges incurred to general and administrative expense for the years ended September 30, 2020 and 2019 is as follows: Balance Expensed / Accrued Cash Balance October 1, 2019 Expense Payments September 30, 2020 Lease termination payments $ 3,909,448 $ 661,663 $ (600,000) $ 3,971,111 Balance Expensed / Accrued Cash Balance Lease termination payments $ 3,850,081 $ 485,117 $ (425,750) $ 3,909,448 Equipment leases The Company has equipment leases with terms between 12 and 36 months and has recorded those leases 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 year ended September 30, 2020 are as follows: Year ended September 30, 2020 Finance lease cost: Amortization of right-of-use assets $ 182,967 Interest on lease liabilities 905,027 Total finance lease cost 1,087,994 Operating lease cost 174,500 Total lease cost $ 1,262,494 Rent expense under operating leases was $1,139,714 for the year ended September 30, 2019. Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of September 30, 2020 are as follows: September 30, 2020 Operating leases: Right-of-use asset $ 166,986 Operating lease liabilities 187,486 Finance leases: Right-of-use asset $ — Financing lease liabilities 72,260 Weighted-average remaining lease term (years): Operating leases 1.0 Finance leases 2.4 Weighted-average discount rate: Operating leases Finance leases Other information related to leases for the year ended September 30, 2020 are as follows: Year ended September 30, 2020 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 905,027 Operating cash flows from operating leases 187,500 Financing cash flows from finance leases 215,074 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — Finance leases — Future minimum payments under noncancelable operating leases at September 30, 2020 are as follows for the years ending September 30: Operating leases Finance leases 2021 $ 195,000 $ 34,869 2022 — 29,605 2023 — 13,149 2024 — 4,383 Total undiscounted lease payments $ 195,000 $ 82,006 Less: Imputed interest 7,514 9,746 Total lease obligations $ 187,486 $ 72,260 Employee Benefit Plan The Company maintains a defined contribution 401(k) plan in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company matches 100% of the first 3% of employee contributions. The Company assumes all administrative costs of the Plan. For the years ended September 30, 2020 and 2019, the expense relating to the matching contribution was $48,315 and $125,828, respectively.

Stockholders_ Equity (Deficit)

Stockholders’ Equity (Deficit)	12 Months Ended
	Sep. 30, 2020
Stockholders’ Equity (Deficit)
Stockholders’ Equity (Deficit)	11. 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. In the 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 significant stockholder and strategic partner, at a combined purchase price per share and accompanying warrant of $1.016 for $2.5 million in gross proceeds. The warrants issued are 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 and concurrent with the termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Refer to Note 13 for the accounting of the restricted stock issued and Note 15 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 (see Note 6). 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. On July 16, 2020, the Company received $1.0 million in gross 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. During the year ended September 30, 2019, the Company issued an aggregate of 2,680,390 shares of the Company’s common stock for gross cash proceeds of $20.0 million ($19.8 million net of issuance costs) pursuant to the November 5, 2018 BioLexis private placement agreement. In April 2019, the Company issued an aggregate of 10,340,000 shares of its common stock, 15-month warrants to purchase up to an aggregate of 10,340,000 shares of common stock and five-year warrants to purchase up to an aggregate of 10,340,000 shares of common stock for $26.2 million in net proceeds after payment of fees, expenses and underwriting discounts and commissions. The shares of common stock and the warrants were immediately separable and were issued separately. The warrants were exercisable immediately at an exercise price of $2.90 per share. During the years ended September 30, 2020 and 2019, the Company issued 109 and 4,069 shares of common stock, respectively, upon the vesting of RSUs. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Subject to preferences that may apply to any outstanding preferred stock, holders of common stock are entitled to receive ratably any dividends that the Company’s board of directors may declare out of funds legally available for that purpose on a non-cumulative basis. No dividends had been declared through September 30, 2020. Common stock warrants As of September 30, 2020, the Company had the following warrants outstanding to acquire shares of its common stock: 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 (i) 277,128 $ 12.00 April 13, 2025 (i) 145,686 $ 12.00 May 31, 2025 (i) 62,437 $ 12.00 February 24, 2025 531,890 $ 1.27 February 26, 2024 5,029,528 $ 0.9535 June 22, 2025 588,519 $ 1.5188 7,051,854 (i) The warrants were issued in connection with the convertible senior secured notes (see Note 9) and are classified as liabilities on the accompanying consolidated balance sheets as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures. On December 23, 2019, the Company amended the terms of its then 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 expired 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 year ended September 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 year ended September 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 (including the warrants exercised by BioLexis on December 26, 2019) 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. During the year ended September 30, 2019, warrants to purchase an aggregate of 10,273,558 shares of common stock with a weighted averaged exercise price of $2.90 were exercised (including the warrants exercised by BioLexis on July 9, 2019) resulting in the issuance of an aggregate 6,134,763 shares of the Company’s common stock. Of these exercised warrants, 10,270,250 of them were 15-month warrants issued in the Company’s April 2019 public offering that were exercised pursuant to the net exercise provisions therein.

Convertible Preferred Stock

Convertible Preferred Stock	12 Months Ended
	Sep. 30, 2020
Convertible Preferred Stock
Convertible Preferred Stock	12. Convertible Preferred Stock Series A‑1 Convertible Preferred Stock A total of 200,000 shares of Series A‑1 have been authorized for issuance under the Certificate of Designation of Series A‑1 Convertible Preferred Stock of the Company. The shares of Series A‑1 have a stated value of $100.00 per share and rank senior to all junior securities (as defined in the Certificate of Designation). The Series A‑1 accrue dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A‑1. The Series A‑1 is also entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of Common Stock or other securities. The initial conversion rate is subject to appropriate adjustment in the event of a stock split, stock dividend, combination, reclassification or other recapitalization affecting the Common Stock. The holders of the Series A‑1 have the right to vote on matters submitted to a vote of the Company’s stockholders on an as-converted basis, voting with the Company’s other stockholders as a single class. In addition, without the prior written consent of a majority of the outstanding shares of Series A‑1, the Company may not take certain actions, including amending its certificate of incorporation or bylaws, or issuing securities ranking pari passu or senior to the Series A‑1. 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 years ended September 30, 2020 and 2019, the Company issued an additional 1,661 and 6,248 shares, respectively, of Series A‑1 to settle the related dividends that were due on a quarterly basis. The Company recognized a beneficial conversion charge of $61,365 during the year ended September 30, 2019 which represents the in-the-money value of the conversion rate as of the date of issuance. At September 30, 2020, there were no shares of Series A-1 outstanding.

Stock-Based Compensation

Stock-Based Compensation	12 Months Ended
	Sep. 30, 2020
Stock-Based Compensation
Stock-Based Compensation	13. 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 September 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 24,022,526. As of September 30, 2020, 20,090,731 shares remained available for grant under the 2015 Plan. Stock options and RSUs granted under the Company's 2015 Plan 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. Year ended September 30, 2020 2019 Research and development $ 1,241,945 $ 37,053 General and administrative 1,565,484 1,276,282 $ 2,807,429 $ 1,313,335 Stock options The following table summarizes all of the Company’s stock option activity for the years ended September 30, 2019 and 2020: Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2018 182,120 $ 7.22 Granted 1,449,498 3.80 Expired (19,077) 7.86 Forfeited (222,542) 8.34 Balance at September 30, 2019 1,389,999 3.46 Granted 2,641,621 1.33 Forfeited (269,477) 2.78 Balance at September 30, 2020 3,762,143 2.01 9.3 $ 85,814 Vested and exercisable 964,754 2.64 8.9 $ 85,814 Vested and expected to vest at September 30, 2020 3,762,143 $ 2.01 9.3 The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model, wherein expected volatility is based on historical volatility of the publicly traded common stock of a peer group of companies. The expected term calculation is based on the “simplified” method described in Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment , and SAB No. 110, Share-Based Payment , since the simplified method provides a reasonable estimate in comparison to actual experience. For options granted to non-employees, the Company uses the remaining contractual life. The risk-free interest rate is based on the U.S. Treasury yield at the date of grant for an instrument with a maturity that is commensurate with the expected term of the stock options. The dividend yield is zero since the Company has never paid cash dividends on its common stock and has no present intention to pay cash dividends. Options granted under the 2015 Plan generally vest over one to four years and have a term of 10 years. The weighted average grant date fair value of the options awarded to employees for the years ended September 30, 2020 and 2019 was $0.96 and $2.86 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: Year ended September 30, 2020 2019 Risk-free interest rate 0.66 % 2.02 % Expected life (years) 5.72 6.14 Expected volatility 90.5 % 92.7 % Expected dividend yield — — As of September 30, 2020, there was $3,216,405 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 2.3 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 years ended September 30, 2020 and 2019: Weighted Average Number Base Remaining of Price Contractual PSUs Per PSU Term (Years) Balance at October 1, 2018 16,131 $ 49.99 Forfeitures (440) 50.60 Balance at September 30, 2019 15,691 49.97 Forfeitures (13,221) 49.97 Balance at September 30, 2020 2,470 49.97 4.0 Vested and exercisable at September 30, 2020 2,470 49.97 4.0 Vested and expected to vest at September 30, 2020 2,470 $ 49.97 4.0 Restricted stock units The Company has granted RSUs that generally vest over a period of two to four years from the date of grant. The following table summarizes the activity related to RSUs during the years ended September 30, 2020 and 2019: Weighted Number Average of Grant Date RSUs Fair Value Balance at September 30, 2018 7,638 $ 153.88 Vested and settled (4,069) 227.57 Forfeitures (3,460) 69.06 Balance at September 30, 2019 109 96.00 Vested and settled (109) 96.00 Balance at September 30, 2020 — $ — Restricted stock In connection with the consulting agreements entered into by the Company and four principals of MTTR, LLC, the Company issued an aggregate of 7,244,739 shares of its common stock. Refer to Note 15 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 TWO clinical trial of ONS-5010 by certain dates. The Company achieved full enrollment for NORSE TWO in June 2020. 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 year ended September 30, 2020, the Company recognized compensation expense related to the restricted stock of $1,301,152. As of September 30, 2020, there was $2,611,007 of unrecognized compensation expense related to the restricted stock.

Collaboration Arrangements

Collaboration Arrangements	12 Months Ended
	Sep. 30, 2020
Collaboration Arrangements
Collaboration Arrangements	14. Collaboration Arrangements During fourth quarter of fiscal year 2019, the Company substantially completed its efforts to outsource the commercial manufacturing and remaining development for the ONS-5010 program, resulting in the termination of the majority of manufacturing and development personnel and initiation of efforts to sell or transfer excess manufacturing, laboratory and related computer equipment no longer required for the development of ONS-5010 program. As a result, the Company no longer has the internal capability to support its inactive development programs for ONS-3010 (biosimilar for Humira) and ONS-1045 (biosimilar for Avastin) and does not intend to complete the development of these assets in the United States and other developed markets. All future development for the biosimilar programs, if any, will be completed by the Company's existing, or potential future, partners without further assistance from the Company. As a result, the Company recognized all remaining deferred revenues as of September 30, 2019 for each of its collaboration agreements. Huahai Agreement In May 2013, the Company entered into strategic license and collaboration arrangement with Zhejiang Huahai Pharmaceutical Co., Ltd (“Huahai”) under which the Company granted Huahai and its affiliates an exclusive license for the research, development, manufacture, use or sale of ONS‑3010 or ONS‑1045 in China, including, the People’s Republic of China, Hong Kong, Macau and Taiwan. In addition, the Company granted Huahai a right and license under the Selexis Technology agreement to establish a production process for the products in the agreed territory and to market the products in the agreed territory pursuant to the relevant terms and conditions of the Company’s commercial license agreement with Selexis. Under the terms of the arrangement, the Company has received $7,500,000 in upfront payments and milestones and received $8,500,000 in substantive milestones. The Company determined that the deliverables under the Huahai arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have a standalone value, the upfront milestones payments received had been deferred and were being recognized ratably on a straight line basis through December 2021, the expected date in which the research and development would be completed prior to the Company’s decision in the fourth quarter of fiscal 2019 to stop developing its biosimilar assets as described fully above. During year ended September 30, 2019, the Company recognized $4,828,584 of deferred revenues. IPCA License and Collaboration Agreement In August 2013, the Company entered into a strategic license agreement with IPCA Laboratories Limited and its affiliates (“IPCA”) under which the Company granted IPCA a license for the research, development, manufacture, use or sale of the ONS‑3010 and, by amendment in May 2014, the ONS‑1045 biosimilar product candidates with respect to India, Sri-Lanka, and Myanmar, and non-exclusive with respect to Nepal and Bhutan, or collectively, the agreed territory. In addition, the Company granted IPCA a right and license under the Selexis Technology to enable IPCA to establish an exclusive production process for the products in its agreed territory and to exclusively market the products in the agreed territory. The Company also agreed not to amend or terminate its rights under its commercial license agreement with Selexis without IPCA’s prior written consent. Pursuant to the agreement, the Company agreed to continue the non-clinical and clinical development of each of ONS‑3010 and ONS‑1045 and corresponding products around the world and to develop and commercialize such products through Phase 3 clinical trials and regulatory approval in the United States and European Union. These obligations continue until termination of the agreement or the individual development programs or upon final regulatory approval of the last product for such biosimilars in the United States or European Union. The Company agreed to provide IPCA with a pre-IND package as submitted to EMEA and FDA, as well as perform preclinical development and characterization of ONS‑3010 and ONS‑1045 so as to enable IPCA to file an IND to conduct clinical trials and to perform clinical trials. Under the terms of the agreement, in prior years the Company received upfront and milestone payments of $2,400,000 and received $1,000,000 in regulatory milestone payments. In addition, the Company is eligible to receive royalties at a low double-digit percentage rate of annual net sales of products by IPCA and its affiliates in the agreed territory. For each of ONS‑3010 and ONS‑1045, IPCA agreed to fund a portion of the global costs associated with the Phase 3 clinical trials. The Company determined that the deliverables under the IPCA arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have standalone value, the upfront and milestones payments received had been deferred and were being recognized ratably on a straight line basis through December 2021 the expected date in which the research and development would be completed prior to the Company’s decision in the fourth quarter of fiscal 2019 to stop developing its biosimilar assets as described fully above. As of September 30, 2019, the Company has received an aggregate of $5.0 million of payments from IPCA under its various agreements. During the year ended September 30, 2019, the Company recognized deferred revenues of $1,664,085. Liomont Agreement In June 2014, the Company entered into a strategic license agreement with Liomont, under which the Company granted Liomont and its affiliates an exclusive, sublicenseable license in Mexico for the research, development, manufacture, use or sale of the ONS‑3010 and ONS‑1045 biosimilar product candidates in Mexico. In addition, the Company granted Liomont a non-exclusive right and license under the Selexis Technology and related intellectual property to enable Liomont to distribute, market and commercialize the products in Mexico. The Company also agreed not to amend or terminate its rights under the commercial agreement with Selexis without Liomont’s prior written consent. Under the terms of the agreement, in prior years the Company received upfront payments and milestone payments of $2,000,000 and received $1,000,000 in regulatory milestone payments. In addition, the Company is eligible to receive up to $2,000,000 in future substantive milestone payments. For each of ONS‑3010 and ONS‑1045, Liomont agreed to fund a portion of the global costs for Phase 3 clinical trials. The Company is eligible to receive tiered royalties at upper single digit to low double-digit percentage rates of annual net sales of products by Liomont and its affiliates in Mexico. The Company determined that the deliverables under the Liomont arrangement were the exclusive license and the research and development services to be completed by the Company. Since the license did not have standalone value, the upfront payments received had been deferred and were being recognized ratably on a straight-line basis through December 2021, the expected date in which the research and development would be completed prior to the Company’s decision in the fourth quarter of the year ended September 30, 2019 to stop developing its biosimilar assets as described fully above. As of September 30, 2019, the Company has received an aggregate of $3.0 million of upfront and milestone payments from Liomont. During the year ended September 30, 2019, the Company recognized deferred revenue of $1,097,412. BioLexis Agreement In July 2017, the Company entered into a strategic licensing agreement with BioLexis, under which it granted BioLexis and its affiliates a perpetual, irrevocable, exclusive sublicensable license in the agreed territory for the research, development, manufacture, use or sale of the ONS‑1045 biosimilar product candidate in the agreed territory. The agreed territory includes all emerging markets, but specifically excludes major developed markets, such as the United States, Canada, Europe, Japan, Australia and New Zealand, and smaller markets where the Company has existing licensing arrangements, such as Mexico, greater China and India. In prior years, the Company received an initial upfront payment from BioLexis of $1.25 million, and an additional $1.25 million upon meeting a notice and acknowledgment milestone. In September 2017 the Company and BioLexis superseded and replaced the strategic license agreement with a Joint Development and License Agreement (the “JDLA”) providing for the development and commercialization of the Company’s ONS‑3010 and ONS‑1045 biosimilar product candidates in the same geographic territories. In exchange for granting BioLexis a perpetual, irrevocable, exclusive, sublicensable license in the agreed territory for the research, development, manufacture, use or sale of the ONS‑3010 and ONS‑1045 biosimilar product candidates in the agreed territory, BioLexis made an additional payment of $2.5 million in connection with the JDLA. The Company may receive up to an additional $2.5 million milestone payments under the JDLA for each licensed product upon achievement of certain net profit thresholds. The parties agreed to share net profits based on sales of licensed products in the agreed territory, in proportions weighed in BioLexis’s favor, subject to adjustment as provided in the agreement. During the years ended September 30, 2019, the Company recognized revenue of $556,042 under the BioLexis agreements. Syntone Strategic Partnership and PRC Joint Venture In connection with a stock purchase agreement entered in May 2020 between the Company and Syntone, 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. As of September 30, 2020, the joint venture had not been formed.

Related-Party Transactions

Related-Party Transactions	12 Months Ended
	Sep. 30, 2020
Related-Party Transactions
Related-Party Transactions	15. 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 year ended September 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 13 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 $1,294,089 and $1,744,933 during the years ended September 30, 2020 and 2019, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 13). As of September 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 sheet. For other related party transactions during the years ended September 30, 2020 and 2019, refer to the Stockholder Notes (Note 8), Debt (Note 9) and the BioLexis Agreement (Note 14).

Income Taxes

Income Taxes	12 Months Ended
	Sep. 30, 2020
Income Taxes
Income Taxes	16. Income Taxes Income tax benefit for the years ended September 30, 2020 and 2019 consists of the following: Year ended September 30, 2020 2019 State tax $ (3,269,157) $ (3,413,806) Foreign tax provision (2,805) 2,805 $ (3,271,962) $ (3,411,001) During the years ended September 30, 2020 and 2019, the Company sold New Jersey State net operating losses (“NOLs”) in the amount of $33,335,492 and $31,168,800, and unused research and development tax credits in the amount of $555,410 and $944,045, resulting in the recognition of income tax benefits of $3,271,157 and $3,415,806, respectively, recorded in the Company’s statement of operations. A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: Year ended September 30, 2020 2019 U.S. federal statutory rate (21.0) % (21.0) % State taxes, net of federal benefit (6.6) (6.6) Sale of New Jersey net operating losses (6.7) (7.1) Net operating loss 6.2 6.1 Deferred true-up 26.8 — Permanent differences (0.3) (0.2) Research and development credit 3.3 0.8 Change in valuation allowance (10.0) 18.6 Other (0.2) 0.4 Effective income tax rate (8.5) % (9.0) % The tax effects of the temporary differences that gave rise to deferred taxes were as follows: September 30, 2020 2019 Deferred tax assets Net operating loss carryforwards $ 54,836,227 $ 47,664,187 Stock-based compensation 795,216 10,583,524 Lease liability 52,702 — Research and development credit carryforward 6,892,133 8,180,511 Foreign tax credits 2,357,309 2,357,309 Accruals and others 307,745 410,390 Gross deferred tax assets 65,241,332 69,195,921 Less: valuation allowance (65,102,402) (68,967,686) 138,930 228,235 Deferred tax liability: Property and equipment (91,990) (228,235) Right-of-use Assets (46,940) — Net deferred tax assets $ — $ — As of September 30, 2020, the Company has approximately $236.5 million and $72.3 million of U.S. federal and New Jersey NOLs that will begin to expire in 2030 and 2039, respectively. As of September 30, 2020, the Company has federal and state research and development tax credit carryforwards of $6.6 million and $0.3 million, respectively, available to reduce future tax liabilities which will begin to expire in 2032 and 2033, respectively. As of September 30, 2020, the Company has federal foreign tax credit (“FTC”) carryforwards of $2.4 million available to reduce future tax liabilities which will begin to expire starting in 2023, of which $1.9 million of the FTC carryforward is included in the balance of unrecognized tax benefits. Realization of the deferred tax asset is contingent on future taxable income and based upon the level of historical losses, management has concluded that the deferred tax asset does not meet the more-likely-than-not threshold for realizability. Accordingly, a full valuation allowance continues to be recorded against the Company’s deferred tax assets as of September 30, 2020 and 2019. The valuation allowance decreased $3.9 million during the year ended September 30, 2020 and increased $7.1 million during the year ended September 30, 2019. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely-than-not be realized. The determination as to whether the tax benefit will more-likely-than-not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes interest and penalties accrued on any unrecognized tax benefits within the provision for income taxes in its consolidated statements of operations. In December 2017, the Tax Cuts and Jobs Act of 2017 (the "Act") was signed into law making significant changes to the Internal Revenue Code. These changes include a federal statutory rate reduction from 34% to 21% effective for tax years beginning after December 31, 2017, the elimination or reduction of certain domestic deductions and credits and limitations on the deductibility of interest expense and executive compensation. For the fiscal years ended September 30, 2020 and 2019, the federal tax rate is 21.0%. The Act also transitions international taxation from a worldwide system to a modified territorial system and includes base erosion prevention measures on non-U.S. earnings, which has the effect of subjecting certain earnings of the Company's foreign subsidiaries to U.S. taxation as global intangible low-taxed income. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Year ended September 30, 2020 2019 Balance at beginning of year $ 1,859,434 $ 1,856,129 Changes based on tax positions related to the current year (2,805) 3,305 Balance at end of year $ 1,856,629 $ 1,859,434 The Company does not anticipate material change in the unrecognized tax benefits in the next 12 months. These unrecognized tax benefits, if recognized, would affect the annual effective tax rate. The Company’s income tax returns for the years from 2011 through 2019 remain open for examination by the Internal Revenue Service as well as various states and municipalities. Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company’s NOL carryforwards may be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carry forward is subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there would be a reduction in the deferred tax assets with an offsetting reduction in the valuation allowance.

Basis of Presentation and Sum_2

Basis of Presentation and Summary of Significant Accounting Policies (Policies)	12 Months Ended
	Sep. 30, 2020
Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation	Basis of presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and Outlook Therapeutics Pty Ltd, its wholly-owned subsidiary incorporated in Australia (the “Subsidiary”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of the Subsidiary to be the U.S. dollar. The Company translates assets and liabilities of its foreign operations at exchange rates in effect at the balance sheet date. The Company records remeasurement gains and losses on monetary assets and liabilities, such as incentive and tax receivables and accounts payables, which are not in the functional currency of the operation. These remeasurement gains and losses are recorded in the consolidated statement of operations as they occur.
Use of estimates	Use of estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary.
Fair value of financial instruments	Fair value of financial instruments 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. At September 30, 2020 and 2019, the Company’s financial instruments included cash, accounts payable, accrued expenses, equipment loans, stockholder notes and the Paycheck Protection Program (the “PPP”) loan under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The carrying amount of accounts payable, accrued expenses, equipment loans, and stockholder notes approximates fair value due to the short-term maturities of these instruments. Fair Value of Other Financial Instruments As of September 30, 2020, the fair value and carrying value of the PPP loan included in long-term debt on the consolidated balance sheets was $837,000 and $904,200, respectively. The estimated fair value for the Company’s PPP loan was based on discounted expected future cash flows using prevailing interest rates which are Level 3 inputs under the fair value hierarchy.
Property and equipment	Property and equipment Property and equipment are recorded at cost. Depreciation and amortization is determined using the straight-line method over the estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the term of the lease or the estimated useful life of the assets, whichever is shorter. Expenditures for maintenance and repairs are expensed as incurred while renewals and betterments are capitalized. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in operations.
Long-lived assets	Long-lived assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. The Company recognized an impairment charge of $0.5 million and $11.3 million during the years ended September 30, 2020 and 2019, respectively, which is described more fully in Note 5.
Leases	Leases 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 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. 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 10 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 September 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 incurred 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.
Stock-based compensation	Stock-based compensation The Company measures equity classified stock-based awards based on the estimated fair value on the date of grant and recognizes compensation expense of those awards on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The Company accounts for forfeitures of stock option awards as they occur. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is described more fully in Note 13. The fair value of each restricted stock award is measured as the fair value per share of the Company’s common stock on the date of grant.
Revenue recognition	Revenue recognition On October 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) and changed its revenue recognition policies accordingly. The standard’s stated core principle is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about: · Contracts with customers – including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations). · Significant judgments and changes in judgments – determining the timing of satisfaction of performance obligations (over time or at a point in time) and determining the transaction price and amounts allocated to performance obligations. · Certain assets  – assets recognized from the costs to obtain or fulfill a contract. The Company’s revenue is generated primarily through collaboration research and license agreements. The terms of these agreements generally contain multiple deliverables which may include (i) licenses, (ii) research and development activities, (iii) clinical manufacturing and, (iv) product supply. The payment terms of these agreements may include nonrefundable upfront fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. The Company typically receives upfront, nonrefundable payments when licensing its intellectual property. The Company’s arrangements fall under ASC 808, Collaborations (“ASC 808”). ASC 808 does not address recognition or measurement matters but prescribes that entities look to other GAAP by analogy, namely ASU 2014-09. As such, the Company completed an analysis of existing contracts with the Company’s collaboration partners and assessed the differences in accounting for such contracts under ASU 2014-09 compared with current revenue accounting standards. Under the ASU 2014-09, the Company treats substantive milestones as forms of variable consideration which is recognized over the estimated performance period. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. The Company adopted the new accounting standard utilizing the modified retrospective method and, therefore, no adjustments were made to amounts in its prior period financial statements. The Company recorded the cumulative effect of adopting the standard as an adjustment to increase accumulated deficit by $3.6 million. During the fiscal year ended September 30, 2020, the Company would have recognized $4.5 million of collaboration revenues under revenue recognition guidance in effect during fiscal 2018 prior to the adoption of ASU 2014-09.
Incentive and tax receivables	Incentive and tax receivables The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable period. The Company’s estimate of the amount of cash refund it expects to receive related to the Australian research and development tax incentive program is included in prepaid expenses and other current assets in the accompanying consolidated balance sheets. As of September 30, 2020, the Company’s estimate of the amount of cash refund it expects to receive in 2021 for 2020 eligible spending as part of this incentive program was $0.8 million. As of September 30, 2019, the Company had a receivable of $1.1 million which was received in 2020 as part of this incentive program. In addition, the Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in prepaid expenses and other current assets in the accompanying consolidated balance sheet. As of September 30, 2019, prepaid expenses and other current assets included $0.1 million for refundable GST on expenses incurred with Australian vendors.
Research and development	Research and development Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid to Australian vendors pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. During the years ended September 30, 2020 and 2019, the Company recorded $0.5 million and $1.2 million, respectively, in its consolidated statements of operations related to the cash refund it expected to receive from the Australian research and development tax incentive program.
Income taxes	Income taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized.
Net loss per share	Net loss per share Basic net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted net loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock 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 potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2020 and 2019, as they would be antidilutive: As of September 30, 2020 2019 Series A-1 convertible preferred stock — 1,255,789 Convertible senior secured notes — 767,605 Convertible unsecured notes — 149,573 Performance-based stock units 2,470 15,691 Restricted stock units — 109 Stock options 3,762,143 1,389,999 Common stock warrants 7,051,854 16,067,948
Recently issued accounting pronouncements	Recently issued accounting pronouncements 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 into 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.

Basis of Presentation and Sum_3

Basis of Presentation and Summary of Significant Accounting Policies (Tables)	12 Months Ended
	Sep. 30, 2020
Basis of Presentation and Summary of Significant Accounting Policies
Schedule of dilutive securities excluded from the computation weighted-average shares	As of September 30, 2020 2019 Series A-1 convertible preferred stock — 1,255,789 Convertible senior secured notes — 767,605 Convertible unsecured notes — 149,573 Performance-based stock units 2,470 15,691 Restricted stock units — 109 Stock options 3,762,143 1,389,999 Common stock warrants 7,051,854 16,067,948

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	12 Months Ended
	Sep. 30, 2020
Fair Value Measurements
Schedule of assets and liabilities measured at fair value on a recurring basis	September 30, 2020 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ — $ — $ 70,772 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 (184,962) (1,796,982) Write off due to extinguishment of senior secured notes — (6,467,469) Balance at September 30, 2020 $ 70,772 $ —
Schedule of fair value of the warrant liability	September 30, 2020 2019 Risk-free interest rate 0.24 % 1.56 % Remaining contractual life of warrant 4.38 years 5.38 years Expected volatility 94.7 % 89.0 % Annual dividend yield 0 % 0 % Fair value of common stock $ 0.72 per share $ 1.49 per share

Property and Equipment (Tables)

Property and Equipment (Tables)	12 Months Ended
	Sep. 30, 2020
Property and Equipment
Schedule of property and equipment	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 (740,102) (1,051,477) $ 327,249 $ 3,175,960

Other Assets (Tables)

Other Assets (Tables)	12 Months Ended
	Sep. 30, 2020
Other Assets
Schedule of other assets	September 30, 2020 2019 Advance to PRC joint venture (see Note 14) $ 900,000 $ — Other assets 394,448 457,476 $ 1,294,448 $ 457,476

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Sep. 30, 2020
Accrued Expenses
Schedule of accrued expenses	September 30, 2020 2019 Compensation $ 579,618 $ 919,394 Severance and related costs 9,521 505,570 Research and development 2,890,333 1,692,040 Interest payable 3,691 934,145 Professional fees 132,085 419,216 Lease termination obligation 3,971,111 — Other accrued expenses 170,951 152,623 $ 7,757,310 $ 4,622,988

Stockholder Notes (Tables)

Stockholder Notes (Tables)	12 Months Ended
	Sep. 30, 2020
Stockholder Notes
Schedule of stockholder notes	September 30, 2020 2019 Restricted stock repurchase notes $ 800,000 $ 800,000 Common stock repurchase note 2,812,500 2,812,500 3,612,500 3,612,500 Less: current portion (3,612,500) (3,612,500) $ — $ —

Debt (Tables)

Debt (Tables)	12 Months Ended
	Sep. 30, 2020
Debt
Schedule of senior secured note	September 30, 2020 2019 Convertible senior secured notes $ — $ 6,699,000
Schedule of other indebtedness	September 30, 2020 2019 Unsecured notes $ — $ 977,966 Paycheck Protection Program term loan 904,200 — Equipment loans 50,285 98,487 954,485 1,076,453 Less: current portion (50,285) (1,026,168) Long-term debt $ 904,200 $ 50,285
Schedule of future maturities of other indebtedness	2021 $ 50,285 2022 904,200 $ 954,485

Commitments and Contingencies (

Commitments and Contingencies (Tables)	12 Months Ended
	Sep. 30, 2020
Leases
Schedule of lease information	The components of lease cost for the year ended September 30, 2020 are as follows: Year ended September 30, 2020 Finance lease cost: Amortization of right-of-use assets $ 182,967 Interest on lease liabilities 905,027 Total finance lease cost 1,087,994 Operating lease cost 174,500 Total lease cost $ 1,262,494 Rent expense under operating leases was $1,139,714 for the year ended September 30, 2019. Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of September 30, 2020 are as follows: September 30, 2020 Operating leases: Right-of-use asset $ 166,986 Operating lease liabilities 187,486 Finance leases: Right-of-use asset $ — Financing lease liabilities 72,260 Weighted-average remaining lease term (years): Operating leases 1.0 Finance leases 2.4 Weighted-average discount rate: Operating leases Finance leases Other information related to leases for the year ended September 30, 2020 are as follows: Year ended September 30, 2020 Cash paid for amounts included in the measurement of lease obligations: Operating cash flows from finance leases $ 905,027 Operating cash flows from operating leases 187,500 Financing cash flows from finance leases 215,074 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — Finance leases —
Schedule of operating lease future minimum payments	Operating leases Finance leases 2021 $ 195,000 $ 34,869 2022 — 29,605 2023 — 13,149 2024 — 4,383 Total undiscounted lease payments $ 195,000 $ 82,006 Less: Imputed interest 7,514 9,746 Total lease obligations $ 187,486 $ 72,260
Schedule of finance lease future minimum payments	Future minimum payments under noncancelable operating leases at September 30, 2020 are as follows for the years ending September 30: Operating leases Finance leases 2021 $ 195,000 $ 34,869 2022 — 29,605 2023 — 13,149 2024 — 4,383 Total undiscounted lease payments $ 195,000 $ 82,006 Less: Imputed interest 7,514 9,746 Total lease obligations $ 187,486 $ 72,260
Cranbury NJ, May 2020 lease termination
Leases
Schedule of future termination payment derecognized	Balance Expensed / Accrued Cash Non-cash Balance October 1, 2019 Expense Payments Adjustments September 30, 2020 Lease termination payments $ — $ 981,987 $ (625,000) $ — $ 356,987 Assets and liabilities derecognition — (842,514) — 842,514 — Other charges — 540,544 (540,544) — — $ — $ 680,017 $ (1,165,544) $ 842,514 $ 356,987
Cranbury NJ, August 2018 lease termination
Leases
Schedule of future termination payment derecognized	Balance Expensed / Accrued Cash Balance October 1, 2019 Expense Payments September 30, 2020 Lease termination payments $ 3,909,448 $ 661,663 $ (600,000) $ 3,971,111 Balance Expensed / Accrued Cash Balance Lease termination payments $ 3,850,081 $ 485,117 $ (425,750) $ 3,909,448

Stockholders_ Equity (Deficit)

Stockholders’ Equity (Deficit) (Tables)	12 Months Ended
	Sep. 30, 2020
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 (i) 277,128 $ 12.00 April 13, 2025 (i) 145,686 $ 12.00 May 31, 2025 (i) 62,437 $ 12.00 February 24, 2025 531,890 $ 1.27 February 26, 2024 5,029,528 $ 0.9535 June 22, 2025 588,519 $ 1.5188 7,051,854

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	12 Months Ended
	Sep. 30, 2020
Stock-Based Compensation
Schedule of stock-based compensation expense	Year ended September 30, 2020 2019 Research and development $ 1,241,945 $ 37,053 General and administrative 1,565,484 1,276,282 $ 2,807,429 $ 1,313,335
Schedule of stock option activity	Weighted Average Weighted Remaining Number of Average Contractual Aggregate Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2018 182,120 $ 7.22 Granted 1,449,498 3.80 Expired (19,077) 7.86 Forfeited (222,542) 8.34 Balance at September 30, 2019 1,389,999 3.46 Granted 2,641,621 1.33 Forfeited (269,477) 2.78 Balance at September 30, 2020 3,762,143 2.01 9.3 $ 85,814 Vested and exercisable 964,754 2.64 8.9 $ 85,814 Vested and expected to vest at September 30, 2020 3,762,143 $ 2.01 9.3
Schedule of option assumptions	Year ended September 30, 2020 2019 Risk-free interest rate 0.66 % 2.02 % Expected life (years) 5.72 6.14 Expected volatility 90.5 % 92.7 % Expected dividend yield — —
Schedule of performance-based stock units activity	Weighted Average Number Base Remaining of Price Contractual PSUs Per PSU Term (Years) Balance at October 1, 2018 16,131 $ 49.99 Forfeitures (440) 50.60 Balance at September 30, 2019 15,691 49.97 Forfeitures (13,221) 49.97 Balance at September 30, 2020 2,470 49.97 4.0 Vested and exercisable at September 30, 2020 2,470 49.97 4.0 Vested and expected to vest at September 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 September 30, 2018 7,638 $ 153.88 Vested and settled (4,069) 227.57 Forfeitures (3,460) 69.06 Balance at September 30, 2019 109 96.00 Vested and settled (109) 96.00 Balance at September 30, 2020 — $ —

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Sep. 30, 2020
Income Taxes
Schedule of Income tax expense	Year ended September 30, 2020 2019 State tax $ (3,269,157) $ (3,413,806) Foreign tax provision (2,805) 2,805 $ (3,271,962) $ (3,411,001)
Schedule of tax expense reconciliation	Year ended September 30, 2020 2019 U.S. federal statutory rate (21.0) % (21.0) % State taxes, net of federal benefit (6.6) (6.6) Sale of New Jersey net operating losses (6.7) (7.1) Net operating loss 6.2 6.1 Deferred true-up 26.8 — Permanent differences (0.3) (0.2) Research and development credit 3.3 0.8 Change in valuation allowance (10.0) 18.6 Other (0.2) 0.4 Effective income tax rate (8.5) % (9.0) %
Schedule of deferred taxes	September 30, 2020 2019 Deferred tax assets Net operating loss carryforwards $ 54,836,227 $ 47,664,187 Stock-based compensation 795,216 10,583,524 Lease liability 52,702 — Research and development credit carryforward 6,892,133 8,180,511 Foreign tax credits 2,357,309 2,357,309 Accruals and others 307,745 410,390 Gross deferred tax assets 65,241,332 69,195,921 Less: valuation allowance (65,102,402) (68,967,686) 138,930 228,235 Deferred tax liability: Property and equipment (91,990) (228,235) Right-of-use Assets (46,940) — Net deferred tax assets $ — $ —
Schedule of reconciliation of unrecognized tax benefits	Year ended September 30, 2020 2019 Balance at beginning of year $ 1,859,434 $ 1,856,129 Changes based on tax positions related to the current year (2,805) 3,305 Balance at end of year $ 1,856,629 $ 1,859,434

Liquidity (Details)

Liquidity (Details) - USD ($)	Nov. 05, 2020	Nov. 30, 2020	Sep. 30, 2020	Sep. 30, 2019	Feb. 28, 2019
Liquidity
Accumulated deficit			$ (289,719,906)	$ (254,480,408)
Proceeds from loan		$ 10,000,000	904,200
Face amount					$ 1,000,000
Repayment of debt			$ 48,202	$ 6,417,652
Unsecured promissory note
Liquidity
Proceeds from loan	$ 10,000,000
Face amount	$ 10,200,000
Interest rate (as a percent)	7.50%
Unamortized discount	$ 200,000
Redemption price, percentage	105.00%
Stockholder Notes
Liquidity
Repayment of debt		$ 3,600,000

Basis of Presentation and Sum_4

Basis of Presentation and Summary of Significant Accounting Policies - Info (Details) $ in Millions	Oct. 01, 2019	Sep. 30, 2020AUD ($)	Sep. 30, 2020USD ($)	Sep. 30, 2019USD ($)
New accounting pronouncements
Impairment of property and equipment			$ 527,624	$ 11,270,110
Lease, Practical Expedients, Package [true false]	true
Operating lease right-of-use assets, net			166,986
Operating leases, Lease obligation			187,486
Finance leases, Lease obligation			72,260
Lease termination obligation			3,971,111
Accumulated deficit			(289,719,906)	(254,480,408)
Annual aggregate eligible revenues		$ 20
Estimate of the amount of cash refund eligible spending as part of this incentive program			800,000
Cash refund receivable				1,100,000
GST receivable				100,000
Operations related to cash refund			$ 500,000	1,200,000
Minimum
New accounting pronouncements
Estimated useful lives		P3Y	P3Y
Maximum
New accounting pronouncements
Estimated useful lives		P10Y	P10Y
ASU 2016-02 Leases | Period of Adoption, 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
Lease termination obligation				$ 3,909,448
ASU 2014-09 Revenue | Period of Adoption, Adjustment
New accounting pronouncements
Accumulated deficit			$ 3,600,000
Collaboration revenue under prior guidance			4,500,000
Paycheck Protection Program
New accounting pronouncements
Fair value			837,000
Carrying value			$ 904,200

Basis of Presentation and Sum_5

Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares	12 Months Ended
	Sep. 30, 2020	Sep. 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		1,255,789
2018 Convertible senior secured 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	15,691
Restricted stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share		109
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	3,762,143	1,389,999
April 2019 Warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	7,051,854	16,067,948

Fair Value Measurements (Detail

Fair Value Measurements (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Liabilities
Warrant liability	$ 70,772	$ 255,734
Fair value measurements recurring basis | Level 3
Liabilities
Warrant liability	$ 70,772	$ 255,734

Fair Value Measurements - Chang

Fair Value Measurements - Changes in fair value (Details)	12 Months Ended
	Sep. 30, 2020USD ($)
April 2019 Warrants
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance, beginning	$ 255,734
Change in fair value	(184,962)
Balance, ending	70,772
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)	Sep. 30, 2020Y$ / shares	Sep. 30, 2019Y$ / shares
Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	0.24	1.56
Remaining contractual life of warrant
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs | Y	4.38	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	94.7	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	0.72	1.49

Property and Equipment (Details

Property and Equipment (Details) - USD ($)	Sep. 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	(740,102)	(1,051,477)
Property and equipment, net	327,249	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		160,086
Land and building
Property, Plant and Equipment [Line Items]
Property and equipment, gross		$ 3,000,000

Property and Equipment - Additi

Property and Equipment - Additional information (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Jun. 30, 2019
Property and Equipment
Depreciation and amortization expense	$ 219,416	$ 3,361,873
Capital lease, gross		3,000,000
Capital lease accumulated depreciation		475,000
Impairment of property and equipment	$ 527,624	11,270,110
Long-lived assets fair value		3,676,008	$ 13,032,320
Assets held for sale		$ 500,000

Other Assets (Details)

Other Assets (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Other Assets
Advance to PRC joint venture	$ 900,000
Other assets	394,448	$ 457,476
Total other assets	$ 1,294,448	$ 457,476

Other Assets - Additional infor

Other Assets - Additional information (Details) - USD ($)	Jul. 16, 2020	Mar. 19, 2020	Jun. 30, 2020	Apr. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Schedule of Equity Method Investments [Line Items]
Sale of common stock, net of issuance costs (in shares)	823,045	7,244,739		10,340,000	13,003,414	6,134,763
Proceeds from issuance of stock	$ 1,000,000			$ 26,200,000	$ 35,430,727	$ 45,964,821
Shares issued, price per share	$ 1.215
P R C Joint Venture
Schedule of Equity Method Investments [Line Items]
Sale of common stock, net of issuance costs (in shares)			16,000,000
Proceeds from issuance of stock			$ 16,000,000
Shares issued, price per share			$ 1

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Accrued Expenses
Compensation	$ 579,618	$ 919,394
Severance and related costs	9,521	505,570
Research and development	2,890,333	1,692,040
Interest payable	3,691	934,145
Professional fees	132,085	419,216
Lease termination obligation	3,971,111
Other accrued expenses	170,951	152,623
Accrued expenses, total	$ 7,757,310	$ 4,622,988

Stockholder Notes (Details)

Stockholder Notes (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Debt Instrument [Line Items]
Stockholder notes	$ 3,612,500	$ 3,612,500
Less: current portion	(3,612,500)	(3,612,500)
Long-tem stockholder notes	0	0
Restricted stock purchase notes
Debt Instrument [Line Items]
Stockholder notes	800,000	800,000
Common stock repurchase note
Debt Instrument [Line Items]
Stockholder notes	$ 2,812,500	$ 2,812,500

Stockholder Notes - Additional

Stockholder Notes - Additional information (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2020	Mar. 07, 2019	Feb. 28, 2019
Debt Instrument [Line Items]
Stockholder notes	$ 3,612,500	$ 3,612,500
Original principal amount				$ 1,000,000
Stockholder Notes
Debt Instrument [Line Items]
Interest expense	105,357
Restricted stock purchase notes
Debt Instrument [Line Items]
Stockholder notes	800,000	$ 800,000
Restricted stock purchase notes | Minimum
Debt Instrument [Line Items]
Interest rate		0.00%
Restricted stock purchase notes | Maximum
Debt Instrument [Line Items]
Interest rate		4.00%
Common stock repurchase note
Debt Instrument [Line Items]
Stockholder notes	$ 2,812,500	$ 2,812,500
Working capital notes
Debt Instrument [Line Items]
Original principal amount			$ 1,000,000
Working capital notes | Minimum
Debt Instrument [Line Items]
Interest rate				0.00%
Working capital notes | Maximum
Debt Instrument [Line Items]
Interest rate				30.00%

Debt - Senior Secured (Details)

Debt - Senior Secured (Details)	1 Months Ended	12 Months Ended
	Dec. 31, 2019USD ($)Ditem	Sep. 30, 2020USD ($)$ / sharesshares	Sep. 30, 2019USD ($)$ / sharesshares	Jan. 27, 2020$ / sharesshares	Jun. 30, 2019USD ($)	May 31, 2019	Apr. 30, 2019$ / shares	Feb. 28, 2019USD ($)	Nov. 30, 2018USD ($)$ / sharesshares	Oct. 31, 2018$ / shares
Debt Instrument [Line Items]
Convertible senior secured notes			$ 6,699,000
Senior secured notes, principal amount								$ 1,000,000
Number of warrants issued | shares		7,051,854		4,657,852
Exercise price per share | $ / shares		$ 0.232	$ 2.90	$ 0.232			$ 2.90
Cash paid for interest		$ 913,967	$ 2,794,572
Loss on extinguishment of debt		(1,896,296)	(607,240)
Senior Notes
Debt Instrument [Line Items]
Interest expense		819,498	1,892,155
2018 Convertible senior secured notes
Debt Instrument [Line Items]
Convertible senior secured notes			6,699,000
Senior secured notes, principal amount					$ 6,700,000				$ 13,500,000
Exchange rate (per share) | $ / shares									$ 8.9539
Number of warrants issued | shares									485,245
Exercise price per share | $ / shares									$ 12	$ 24
Warrants fair value									$ 1,500,000
Total amortization of the debt discount		235,636	1,314,321
Carrying value of notes exchanged	$ 7,254,077		400,575
Accrued interest of notes exchanged			$ 1,393
Common stock issued upon conversion (in shares) | shares			50,394
Repayment of principal amount			$ 6,400,000
Cash paid for interest			1,300,000
Interest rate (as a percent)					5.00%	12.00%
Loss on extinguishment of debt		(8,060,580)	$ (423,686)
2019 Convertible senior secured notes
Debt Instrument [Line Items]
Convertible senior secured notes		$ 0
Senior secured notes, principal amount	334,950
Exchange rate (per share) | $ / shares		$ 0.66
Carrying value of notes exchanged	$ 7,589,027	$ 7,994,494
Common stock issued upon conversion (in shares) | shares		12,201,461
Interest rate (as a percent)	12.00%
Loss on extinguishment of debt		$ 6,164,284
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

Debt - Other Indebtedness Summa

Debt - Other Indebtedness Summary (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Mar. 07, 2019
Debt Instrument [Line Items]
Total other indebtedness	$ 954,485	$ 1,076,453
Less: current portion	(50,285)	(1,026,168)
Long-term debt	904,200	50,285
Unsecured notes
Debt Instrument [Line Items]
Total other indebtedness		977,966
Working capital notes
Debt Instrument [Line Items]
Total other indebtedness			$ 1,947,133
Paycheck Protection Program
Debt Instrument [Line Items]
Total other indebtedness	904,200
Equipment loan
Debt Instrument [Line Items]
Total other indebtedness	$ 50,285	$ 98,487

Debt - Other Indebtedness (Deta

Debt - Other Indebtedness (Details)	May 04, 2020USD ($)	Mar. 07, 2019USD ($)Ditem$ / shares	Nov. 30, 2020USD ($)	Sep. 30, 2020USD ($)$ / sharesshares	Sep. 30, 2019USD ($)	Feb. 28, 2019USD ($)
Debt Instrument [Line Items]
Original principal amount						$ 1,000,000
Total other indebtedness				$ 954,485	$ 1,076,453
Proceeds from loan			$ 10,000,000	904,200
Other Indebtedness
Debt Instrument [Line Items]
Interest expense				25,628	83,963
Unsecured notes
Debt Instrument [Line Items]
Total other indebtedness					977,966
Interest rate (as a percent)		12.00%
Conversion rate per share | $ / shares		$ 13.44
Stock price threshold (as a percent)		95.00%
Number of lowest closing bid prices | item		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
Exchange rate (per share) | $ / shares		$ 13.44
Unsecured notes | Weighted average
Debt Instrument [Line Items]
Conversion rate per share | $ / shares				$ 1.05
Exchange rate (per share) | $ / shares				$ 1.05
Paycheck Protection Program
Debt Instrument [Line Items]
Total other indebtedness				$ 904,200
Interest rate (as a percent)	1.00%
Proceeds from loan	$ 904,200
Deferral term	6 months
Debt Instrument, term	2 years
Equipment loan
Debt Instrument [Line Items]
Total other indebtedness				$ 50,285	$ 98,487
Equipment loan | Minimum
Debt Instrument [Line Items]
Interest rate (as a percent)				12.00%
Debt Instrument, term				1 year
Equipment loan | Maximum
Debt Instrument [Line Items]
Interest rate (as a percent)				16.00%
Debt Instrument, term				5 years
Working capital notes
Debt Instrument [Line Items]
Original principal amount		$ 1,000,000
Total other indebtedness		$ 1,947,133
Monthly stated interest rate		2.50%
Working capital notes | Minimum
Debt Instrument [Line Items]
Interest rate (as a percent)						0.00%
Working capital notes | Maximum
Debt Instrument [Line Items]
Interest rate (as a percent)						30.00%

Debt - Other Indebtedness Matur

Debt - Other Indebtedness Maturities (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Debt
2021	$ 50,285
2022	904,200
Total other indebtedness	$ 954,485	$ 1,076,453

Commitments and Contingencies_2

Commitments and Contingencies (Details)	12 Months Ended
	Sep. 30, 2020USD ($)
Other Commitments [Line Items]
Loss Contingency, Damages Sought, Value	$ 3,000,000
Selexis
Other Commitments [Line Items]
Expected future investment	$ 381,174

Commitments and Contingencies -

Commitments and Contingencies - Lease termination (Details)	May 11, 2020USD ($)	May 06, 2020USD ($)ft²	Aug. 31, 2018USD ($)	Sep. 30, 2020USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)
Commitment
Lease termination obligation				$ 3,971,111
Loss on lease termination				680,017
Cranbury NJ, May 2020 lease termination
Commitment
Net rentable area | ft²		66,000
Lease termination obligation	$ 981,987	$ 981,987		$ 356,987
Terms of payment for lease		8 months
Loss on lease termination	$ 680,017
Cranbury NJ, August 2018 lease termination
Commitment
Lease termination obligation			$ 5,800,000			$ 4,200,000
Terms of payment for lease			30 months
Loss on lease termination					$ 4,200,000
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

Commitments and Contingencies_3

Commitments and Contingencies - Lease termination rollforward (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Leases
Balance, ending	$ 3,971,111
Cranbury NJ, May 2020 lease termination
Leases
Expensed accrued expense	680,017
Cash payments	(1,165,544)
Non cash items	842,514
Balance, ending	356,987
Cranbury NJ, May 2020 lease termination | Lease termination payments
Leases
Expensed accrued expense	981,987
Cash payments	(625,000)
Balance, ending	356,987
Cranbury NJ, May 2020 lease termination | Assets and liabilities derecognition
Leases
Expensed accrued expense	(842,514)
Non cash items	842,514
Cranbury NJ, May 2020 lease termination | Other charges
Leases
Expensed accrued expense	540,544
Cash payments	(540,544)
Cranbury NJ, August 2018 lease termination
Leases
Balance, beginning		$ 4,200,000
Cranbury NJ, August 2018 lease termination | Lease termination payments
Leases
Balance, beginning	3,909,448	3,850,081
Expensed accrued expense	661,663	485,117
Cash payments	(600,000)	(425,750)
Balance, ending	$ 3,971,111	$ 3,909,448

Commitments and Contingencies_4

Commitments and Contingencies - Lease cost (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Lease cost
Amortization of right-of-use assets	$ 182,967
Interest on lease liabilities	905,027
Total finance lease cost	1,087,994
Operating lease cost	174,500
Total lease cost	$ 1,262,494
Rent expense prior to adoption of ASU		$ 1,139,714
Minimum
Leases
Finance lease term	12 months
Finance lease interest (as a percent)	4.00%
Maximum
Leases
Finance lease term	36 months
Finance lease interest (as a percent)	13.00%

Commitments and Contingencies_5

Commitments and Contingencies - Lease balance sheet (Details)	Sep. 30, 2020USD ($)
Leases
Operating leases, Right-of-use asset	$ 166,986
Operating leases, Lease obligation	187,486
Finance leases, Lease obligation	$ 72,260
Operating leases, Weighted-average remaining lease term	1 year
Finance leases, Weighted-average remaining lease term	2 years 4 months 24 days
Operating leases, Weighted-average discount rate (as a percent)	9.00%
Finance leases, Weighted-average discount rate (as a percent)	8.50%

Commitments and Contingencies_6

Commitments and Contingencies - Lease cashflow (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Leases
Operating cash flows from finance leases	$ 905,027
Operating cash flows from operating leases	187,500
Financing cash flows from finance leases	$ 215,074	$ 526,087
Right-of-use assets obtained in exchange for finance lease obligations		$ 48,683

Commitments and Contingencies_7

Commitments and Contingencies - Lease minimum payments (Details)	Sep. 30, 2020USD ($)
Operating leases
2021	$ 195,000
Total undiscounted lease payments	195,000
Less: Imputed interest	7,514
Total lease obligations	187,486
Finance leases
2021	34,869
2022	29,605
2023	13,149
2024	4,383
Total undiscounted lease payments	82,006
Less: Imputed interest	9,746
Total lease obligations	$ 72,260

Commitments and Contingencies_8

Commitments and Contingencies - Employee Benefit (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Commitments
Maximum employee annual contributions (as a percent)	100.00%
Maximum employer annual contributions (as a percent)	100.00%
Maximum employer match (as a percent)	3.00%
Expense related to matching contribution	$ 48,315	$ 125,828

Stockholders_ Equity (Deficit_2

Stockholders’ Equity (Deficit) - Common Stock (Details)	Jul. 16, 2020USD ($)$ / sharesshares	Mar. 19, 2020itemshares	Jun. 30, 2020USD ($)$ / sharesshares	Feb. 29, 2020USD ($)$ / sharesshares	Apr. 30, 2019USD ($)$ / sharesshares	Sep. 30, 2020USD ($)$ / sharesshares	Sep. 30, 2019USD ($)$ / sharesshares	Jan. 27, 2020individual$ / sharesshares
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued	823,045	7,244,739			10,340,000	13,003,414	6,134,763
Shares issued, price per share | $ / shares	$ 1.215
Proceeds from issuance of stock | $	$ 1,000,000				$ 26,200,000	$ 35,430,727	$ 45,964,821
Number of warrants issued						7,051,854		4,657,852
Exercise price per share | $ / shares					$ 2.90	$ 0.232	$ 2.90	$ 0.232
Number of principals | item		4
Number of executive officers		2						2
Issuance of vested restricted stock units (in shares)						109	4,069
Direct registered offering
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued			8,407,411	7,598,426
Shares issued, price per share | $ / shares			$ 1.215	$ 1.016
Proceeds from issuance of stock | $			$ 10,200,000	$ 7,700,000
Number of warrants issued			588,519	3,799,213
Exercise price per share | $ / shares			$ 1.51875
Warrants exercise term			5 years
Private Placement
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued			16,000,000	2,460,630			2,680,390
Shares issued, price per share | $ / shares			$ 1	$ 1.016
Proceeds from issuance of stock | $			$ 16,000,000	$ 2,500,000			$ 20,000,000
Number of warrants issued				1,230,315
Exercise price per share | $ / shares				$ 0.9535
Warrants exercise term				4 years
Proceeds from stock issuance, net of costs | $							$ 19,800,000
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

Stockholders_ Equity (Deficit_3

Stockholders’ Equity (Deficit) - Warrants (Details) - USD ($)	Jul. 16, 2020	Mar. 19, 2020	Jan. 27, 2020	Apr. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Mar. 23, 2020	Dec. 23, 2019	Apr. 12, 2019
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share			$ 0.232	$ 2.90	$ 0.232	$ 2.90
Number of warrants issued			4,657,852		7,051,854
Net proceeds from warrants			$ 1,100,000
Issuance of common stock in connection with exercise of warrants (in shares)					15,085,240	10,273,558
Deemed dividend upon modification of warrants					$ 3,140,009	$ 829,530
Number of share issued	823,045	7,244,739		10,340,000	13,003,414	6,134,763
Warrant expired (in shares)					80,797
Warrants expired (in dollars per share)					$ 0.08
April 2019 Warrants
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share							$ 0.232	$ 0.2320	$ 2.90
Number of warrants issued					10,157,050
Warrant, 15 Months
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Warrants exercise term				15 months				15 months
Number of warrants issued				10,340,000		10,270,250
Warrant, 5 Years
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Warrants exercise term				5 years				5 years
February 18, 2022
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share					$ 12
Number of warrants issued					416,666
December 22, 2024
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share					$ 12
Number of warrants issued					277,128
April 13, 2025
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share					$ 12
Number of warrants issued					145,686
May 31, 2025
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share					$ 12
Number of warrants issued					62,437
February 24, 2025
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share					$ 1.27
Number of warrants issued					531,890
February 26, 2024
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share					$ 0.9535
Number of warrants issued					5,029,528
June 22, 2025
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share					$ 1.5188
Number of warrants issued					588,519

Convertible Preferred Stock (De

Convertible Preferred Stock (Details) - USD ($)	Jul. 16, 2020	Mar. 23, 2020	Mar. 19, 2020	Apr. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Mar. 22, 2020	Jan. 27, 2020
Convertible Preferred Stock [Line Items]
Shares issued, price per share	$ 1.215
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)	823,045		7,244,739	10,340,000	13,003,414	6,134,763
Exercise price per share				$ 2.90	$ 0.232	$ 2.90		$ 0.232
Deemed Dividend, Amendment Of Series A1 Convertible Preferred Stock					$ 10,328,118
Beneficial conversion charge						$ 61,365
Series A-1 convertible preferred stock
Convertible Preferred Stock [Line Items]
Convertible preferred stock, shares authorized					200,000	200,000
Shares issued, price per share					$ 100
Convertible stock, par value (in dollars per share)					$ 0.01	$ 0.01
Dividend rate					10.00%
Sale of Series A convertible preferred stock and common stock warrants, net of costs (in shares)		29,358,621
Number of stock converted		68,112
Conversion rate per share		$ 431.03447263					$ 18.89797
Deemed Dividend, Amendment Of Series A1 Convertible Preferred Stock					$ 10,328,118
Preferred stock issued to settle dividends (in shares)					1,661	6,248
Beneficial conversion charge						$ 61,365
Convertible preferred stock outstanding					0	66,451

Stock-Based Compensation - Info

Stock-Based Compensation - Information (Details) - $ / shares	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Performance-based stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years
Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average grant date fair value of the options awarded to employees	$ 0.96	$ 2.86
Stock options | Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	1 year
Stock options | Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	4 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	24,022,526
Number of shares available for grant	20,090,731
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
2015 Equity Incentive Plan | Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years

Stock-Based Compensation - Expe

Stock-Based Compensation - Expense (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 2,807,429	$ 1,313,335
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	1,241,945	37,053
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,565,484	$ 1,276,282

Stock-Based Compensation - Stoc

Stock-Based Compensation - Stock option activity (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Number of Shares
Balance, Beginning	1,389,999	182,120
Granted	2,641,621	1,449,498
Expired		(19,077)
Forfeited	(269,477)	(222,542)
Balance, Ending	3,762,143	1,389,999
Vested and exercisable	964,754
Vested and expected to vest	3,762,143
Weighted Average Exercise Price
Balance, Beginning	$ 3.46	$ 7.22
Granted	1.33	3.80
Expired		7.86
Forfeited	2.78	8.34
Balance, Ending	2.01	$ 3.46
Vested and exercisable	2.64
Vested and expected to vest	$ 2.01
Other option information
Balance	9 years 3 months 18 days
Vested and exercisable	8 years 10 months 24 days
Vested and expected to vest	9 years 3 months 18 days
Aggregate intrinsic value	$ 85,814
Aggregate intrinsic value, Vest and exercisable	$ 85,814

Stock-Based Compensation - Opti

Stock-Based Compensation - Option Assumptions (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	0.66%	2.02%
Expected life (years)	5 years 8 months 19 days	6 years 1 month 21 days
Expected volatility	90.50%	92.70%
Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected dividend yield	0.00%
Unrecognized compensation expense	$ 3,216,405
Weighted average exercise period of unrecognized compensation	2 years 3 months 18 days

Stock-Based Compensation - Perf

Stock-Based Compensation - Performance-Based (Details) - Performance-based stock units - $ / shares	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years
Number of PSUs
Balance, Beginning	15,691	16,131
Forfeitures	(13,221)	(440)
Balance, Ending	2,470	15,691
Vested and exercisable	2,470
Vested and expected to vest	2,470
Weighted Average Base Price Per Unit
Balance, Beginning	$ 49.97	$ 49.99
Vested and exercisable	49.97
Forfeitures	49.97	50.60
Vested and expected to vest	49.97
Balance, Ending	$ 49.97	$ 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 - $ / shares	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Number of RSUs
Balance, Beginning	109	7,638
Vested and settled	(109)	(4,069)
Forfeitures		(3,460)
Balance, Ending		109
Weighted Average Grant Date Fair Value
Balance, Beginning	$ 96	$ 153.88
Vested and settled	$ 96	227.57
Forfeitures		69.06
Balance, Ending		$ 96
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	2 years
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	4 years

Stock-Based Compensation - Re_2

Stock-Based Compensation - Restricted stock (Details)	Jul. 16, 2020shares	Mar. 19, 2020itemshares	Jan. 27, 2020item$ / sharesshares	Apr. 30, 2019shares	Sep. 30, 2020USD ($)shares	Sep. 30, 2019USD ($)shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of principals | item		4
Issuance of vested restricted stock units (in shares)					109	4,069
Number of share issued	823,045	7,244,739		10,340,000	13,003,414	6,134,763
Stock-based compensation expense | $					$ 2,807,429	$ 1,313,335
MTTR, LLC (“MTTR”)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of principals | item			4
Issuance of vested restricted stock units (in shares)			7,244,739
Number of share issued			7,244,739
Restricted Stock | MTTR, LLC (“MTTR”)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
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 | $					1,301,152
Unamortized expense to be recognized of stock awards other than options | $					$ 2,611,007
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%

Collaboration Arrangements (Det

Collaboration Arrangements (Details) - USD ($)	1 Months Ended						12 Months Ended
	Jun. 30, 2020	Sep. 30, 2017	Jul. 31, 2017	Jun. 30, 2014	Aug. 31, 2013	May 31, 2013	Sep. 30, 2020	Sep. 30, 2019	May 31, 2020
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Investment in joint venture							$ 900,000
Huahai Agreement
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Upfront payment						$ 7,500,000
Milestone payment received						$ 8,500,000
Revenue recognition deferred revenue								$ 4,828,584
IPCA License and Collaboration Agreement
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Upfront payment					$ 2,400,000
Milestone payment received					$ 1,000,000			5,000,000
Revenue recognition deferred revenue								1,664,085
Liomont agreement
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Upfront payment				$ 2,000,000
Milestone payment received				1,000,000				3,000,000
Revenue recognition deferred revenue								1,097,412
Future milestone payments				$ 2,000,000
BioLexis Agreement
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Upfront payment			$ 1,250,000
Milestone payment received		$ 2,500,000	$ 1,250,000
Revenue recognition deferred revenue								$ 556,042
Future milestone payments		$ 2,500,000
Syntone Strategic Partnership and PRC Joint Venture
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Ownership percentage									20.00%
Syntone Strategic Partnership and PRC Joint Venture | P R C Joint Venture
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Investment in joint venture	$ 900,000
Milestone payments amount	$ 2,100,000
Period over which additional investment in joint venture will be made	4 years
Syntone Strategic Partnership and PRC Joint Venture | Syntone
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Ownership percentage									80.00%

Related-Party Transactions (Det

Related-Party Transactions (Details)	Jul. 16, 2020shares	Mar. 19, 2020itemshares	Jan. 27, 2020USD ($)itemindividualshares	Apr. 30, 2019shares	Sep. 30, 2020USD ($)shares	Sep. 30, 2019USD ($)shares
Related Party Transaction [Line Items]
Number of principals | item		4
Number Of Executive Officers		2	2
Shares issued during period | shares	823,045	7,244,739		10,340,000	13,003,414	6,134,763
Acquired additional laboratory and office equipment						$ 437,307
Operating leases, Lease obligation					$ 195,000
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					1,294,089	1,744,933
Due to related party, current					$ 89,762	$ 365,301

Income Taxes (Details)

Income Taxes (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Income Taxes
State tax	$ (3,269,157)	$ (3,413,806)
Foreign tax provision	(2,805)	2,805
Income tax benefit	$ (3,271,962)	$ (3,411,001)

Income Taxes - Reconciliation o

Income Taxes - Reconciliation of income tax expense (benefit) (Details)	Jan. 01, 2018	Dec. 31, 2017	Sep. 30, 2020	Sep. 30, 2019
Income Taxes
U.S. federal statutory rate	(21.00%)	(34.00%)	(21.00%)	(21.00%)
State taxes, net of federal benefit			(6.60%)	(6.60%)
Sale of New Jersey net operating losses			(6.70%)	(7.10%)
Net operating loss			6.20%	6.10%
Deferred true-up			26.80%
Permanent differences			(0.30%)	(0.20%)
Research and development credit			3.30%	0.80%
Change in valuation allowance			(10.00%)	18.60%
Other			(0.20%)	0.40%
Effective income tax rate			(8.50%)	(9.00%)

Income Taxes - Deferred (Detail

Income Taxes - Deferred (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Deferred tax assets
Net operating loss carryforwards	$ 54,836,227	$ 47,664,187
Stock-based compensation	795,216	10,583,524
Lease liability	52,702
Research and development credit carryforward	6,892,133	8,180,511
Foreign tax credits	2,357,309	2,357,309
Accruals and others	307,745	410,390
Gross deferred tax assets	65,241,332	69,195,921
Less: valuation allowance	(65,102,402)	(68,967,686)
Deferred tax assets net of valuation allowance	138,930	228,235
Deferred tax liability:
Property and equipment	(91,990)	$ (228,235)
Right-of-use Assets	$ (46,940)

Income Taxes - Additional infor

Income Taxes - Additional information (Details) - USD ($)	Jan. 01, 2018	Dec. 31, 2017	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2018
Operating Loss Carryforwards [Line Items]
Research and development tax credit carryforwards			$ 6,892,133	$ 8,180,511
Recognition of income tax benefits			(3,271,962)	(3,411,001)
Foreign tax credit carryforwards			2,357,309	2,357,309
Unrecognized tax benefits			1,856,629	1,859,434	$ 1,856,129
Increase (decrease) in valuation allowance			$ (3,900,000)	$ 7,100,000
U.S. federal statutory rate	(21.00%)	(34.00%)	(21.00%)	(21.00%)
New Jersey
Operating Loss Carryforwards [Line Items]
NOL carryforwards			$ 33,335,492	$ 31,168,800
Research and development tax credit carryforwards			555,410	944,045
Recognition of income tax benefits			(3,271,157)	(3,415,806)
Federal
Operating Loss Carryforwards [Line Items]
NOL carryforwards				236,500,000
Research and development tax credit carryforwards			6,600,000
Foreign tax credit carryforwards			2,400,000
State
Operating Loss Carryforwards [Line Items]
NOL carryforwards				$ 72,300,000
Research and development tax credit carryforwards			$ 300,000

Income Taxes - Unrecognized tax

Income Taxes - Unrecognized tax benefits (Details) - USD ($)	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward]
Balance at beginning of year	$ 1,859,434	$ 1,856,129
Changes based on tax positions related to the current year	(2,805)	3,305
Balance at end of year	$ 1,856,629	$ 1,859,434