0001558370-21-017007 | 10-K | XBRL Viewer

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Document And Entity Information - USD ($) $ in Millions	12 Months Ended
Document And Entity Information - USD ($) $ in Millions	Sep. 30, 2021	Dec. 20, 2021	Mar. 31, 2021
Document And Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Sep. 30, 2021
Document Transition Report	false
Entity File Number	001-37759
Entity Registrant Name	OUTLOOK THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	38-3982704
Entity Address, Address Line One	485 Route 1 South
Entity Address, Address Line Two	Building F, Suite 320
Entity Address, City or Town	Iselin
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08852
City Area Code	609
Local Phone Number	619-3990
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	false
ICFR Auditor Attestation Flag	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		224,260,602
Entity Public Float			$ 199.5
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	FY
Amendment Flag	false
Common Stock
Document And Entity Information
Title of 12(b) Security	Common Stock
Trading Symbol	OTLK
Security Exchange Name	NASDAQ
Series A Warrants
Document And Entity Information
Title of 12(b) Security	Series A Warrants
Trading Symbol	OTLKW
Security Exchange Name	NASDAQ

Consolidated Balance Sheets - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Current assets:
Cash and cash equivalents	$ 14,477,324	$ 12,535,986
Prepaid expenses and other current assets	7,030,823	5,407,882
Total current assets	21,508,147	17,943,868
Property and equipment, net	163,625	327,249
Operating lease right-of-use assets, net	111,429	166,986
Equity method investment	853,660
Other assets	174,590	1,294,448
Total assets	22,811,451	19,732,551
Current liabilities:
Current portion of long-term debt	904,200	50,285
Current portion of finance lease liabilities	26,464	29,778
Current portion of operating lease liabilities	42,854	187,486
Stockholder notes		3,612,500
Accounts payable	2,196,349	2,394,818
Accrued expenses	1,725,721	7,757,310
Income taxes payable	1,856,629	1,856,629
Total current liabilities	6,752,217	15,888,806
Long-term debt	10,885,854	904,200
Finance lease liabilities	16,018	42,482
Operating lease liabilities	26,995
Warrant liability	522,918	70,772
Total liabilities	18,204,002	16,906,260
Commitments and contingencies (Note 9)
Convertible preferred stock:
Total convertible preferred stock
Stockholders' equity:
Preferred stock, value
Common stock, par value $0.01 per share; 325,000,000 shares authorized; 176,461,628 and 127,183,109 shares issued and outstanding at September 30, 2021 and 2020, respectively	1,764,616	1,271,831
Additional paid-in capital	345,726,087	291,274,366
Accumulated deficit	(342,883,254)	(289,719,906)
Total stockholders' equity	4,607,449	2,826,291
Total liabilities, convertible preferred stock and stockholders' equity	22,811,451	19,732,551
Series A convertible preferred stock
Convertible preferred stock:
Total convertible preferred stock
Convertible Preferred Stock Series A-1
Convertible preferred stock:
Total convertible preferred stock
Series B convertible preferred stock
Stockholders' equity:
Preferred stock, value

Consolidated Balance Sheets (Parentheticals) - $ / shares	Sep. 30, 2021	Sep. 30, 2020
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	325,000,000	325,000,000
Common stock, shares issued	176,461,628	127,183,109
Common stock, shares outstanding	176,461,628	127,183,109
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
Convertible Preferred Stock Series A-1
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	0
Convertible preferred stock outstanding	0	0
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 Operations - USD ($)	12 Months Ended
Consolidated Statements of Operations - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Operating expenses:
Research and development	$ 38,958,010	$ 26,341,998
General and administrative	12,768,725	9,971,015
Impairment of property and equipment		527,624
Total operating expenses	51,726,735	36,840,637
Loss from operations	(51,726,735)	(36,840,637)
Loss on equity method investment	46,340
Interest expense, net	936,127	1,756,471
Loss on extinguishment of debt		1,896,296
Change in fair value of redemption feature		(1,796,982)
Change in fair value of warrant liability	452,146	(184,962)
Loss before income taxes	(53,161,348)	(38,511,460)
Income tax expense (benefit)	2,000	(3,271,962)
Net loss	(53,163,348)	(35,239,498)
Series A-1 convertible preferred stock dividends and related settlement		(166,133)
Deemed dividend upon modification of warrants		(3,140,009)
Deemed dividend upon amendment of the terms of the Series A-1 convertible preferred stock		(10,328,118)
Net loss attributable to common stockholders	$ (53,163,348)	$ (48,873,758)
Per share information:
Net loss per share of common stock, basic (in dollars per share)	$ (0.35)	$ (0.67)
Net loss per share of common stock, diluted (in dollars per share)	$ (0.35)	$ (0.67)
Weighted average shares outstanding, basic (in shares)	152,676,145	72,555,636
Weighted average shares outstanding, diluted (in shares)	152,676,145	72,555,636

Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($)	Preferred Stock Convertible Preferred Stock Series A-1	Common Stock MTTR, LLC ("MTTR")	Common Stock	Additional Paid-in Capital MTTR, LLC ("MTTR")	Additional Paid-in Capital	Accumulated Deficit	Convertible Preferred Stock Series A-1	Total
Balance at Sep. 30, 2019	$ 5,359,404		$ 286,100		$ 238,064,947	$ (254,480,408)		$ (16,129,361)
Balance, beginning (in shares) at Sep. 30, 2019	66,451		28,609,995
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with exercise of warrants			$ 130,034		1,008,866			1,138,900
Issuance of common stock in connection with exercise of warrants (in shares)			13,003,414
Issuance of common stock in connection with conversion of stockholder notes and interest			$ 14,753		1,533,673			1,548,426
Issuance of common stock in connection with conversion of stockholder notes and interest (in shares)			1,475,258
Sale of common stock, net of issuance costs		$ 72,447	$ 352,895	$ (72,447)	34,993,602			35,346,497
Sale of common stock, net of issuance costs (in shares)		7,244,739	35,289,512
Issuance of common stock in connection with conversion of senior secured notes and interest			$ 122,015		7,872,479			$ 7,994,494
Issuance of common stock in connection with conversion of senior secured notes and interest (in shares)			12,201,461
Issuance of vested restricted stock units			$ 1		(1)
Issuance of vested restricted stock units (in shares)			109					109
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
Conversion of Series A-1 convertible preferred stock to common stock	$ (5,525,537)		$ 293,586		5,231,951			5,525,537
Conversion of Series A-1 convertible preferred stock to common stock (in shares)	(68,112)		29,358,621
Stock-based compensation expense					2,807,429			2,807,429
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
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with exercise of warrants			$ 38,159		3,555,221			3,593,380
Issuance of common stock in connection with exercise of warrants (in shares)			3,815,935
Sale of common stock, net of issuance costs			$ 454,626		46,009,213			46,463,839
Sale of common stock, net of issuance costs (in shares)			45,462,584
Stock-based compensation expense					4,887,287			4,887,287
Net loss						(53,163,348)		(53,163,348)
Balance at Sep. 30, 2021			$ 1,764,616		$ 345,726,087	$ (342,883,254)		$ 4,607,449
Balance, ending (in shares) at Sep. 30, 2021			176,461,628

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
Consolidated Statements of Cash Flows - USD ($)	Sep. 30, 2021	Sep. 30, 2020
OPERATING ACTIVITIES
Net loss	$ (53,163,348)	$ (35,239,498)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	262,140	554,069
Loss on extinguishment of debt		1,896,296
Non-cash interest expense	893,886	235,636
Stock-based compensation	4,887,287	2,807,429
Change in fair value of redemption feature		(1,796,982)
Change in fair value of warrant liability	452,146	(184,962)
Impairment of property and equipment		527,624
Gain on settlement of lease termination obligation	(552,340)
Loss on lease termination		680,017
Loss on equity method investment	46,340
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(1,729,944)	(310,270)
Other assets	298,523	(84,120)
Operating lease liability	(150,346)	(164,686)
Accounts payable	(198,469)	(1,489,760)
Accrued expenses	(5,299,163)	726,332
Income taxes payable		(2,805)
Other liabilities		55,587
Net cash used in operating activities	(54,253,288)	(31,790,093)
INVESTING ACTIVITIES
Investment in joint venture		(900,000)
Net cash used in investing activities		(900,000)
FINANCING ACTIVITIES
Proceeds from the sale of common stock, net of issuance costs	46,301,841	35,430,727
Proceeds from debt	10,000,000	904,200
Payment of debt issuance costs	(8,032)
Proceeds from exercise of common stock warrants	3,593,380	1,138,900
Payments of finance lease obligations	(29,778)	(215,074)
Repayment of stockholder notes	(3,612,500)
Repayment of debt	(50,285)	(48,202)
Net cash provided by financing activities	56,194,626	37,210,551
Net increase in cash	1,941,338	4,520,458
Cash and cash equivalents at beginning of period	12,535,986	8,015,528
Cash and cash equivalents at end of period	14,477,324	12,535,986
Supplemental disclosure of cash flow information
Cash paid for interest	$ 46,239	913,967
Accrued interest settled by conversion into common stock		1,531,004
Supplemental schedule of non-cash financing activities:
Senior secured notes principal converted into common stock		7,033,950
Unsecured notes principal converted into common stock		977,966
Issuance of exchange notes at estimated fair value		7,050,206
Issuance of redemption feature at estimated fair value		8,264,451
Series A-1 convertible preferred stock dividends and related settlement		166,133
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses		$ 84,230

Organization and Operations

12 Months Ended

Sep. 30, 2021

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 Iselin, New Jersey.

The Company has been actively monitoring the 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 development activities are currently active in support of the Company’s Biologics License Application (“BLA”) registration program for ONS-5010 for wet age-related macular degeneration (“wet AMD”).

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, 2021 were not significantly impacted by COVID-19.

Liquidity

12 Months Ended

Sep. 30, 2021

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 $342.9 million as of September 30, 2021. As of September 30, 2021, the Company had $10.9 million of principal and accrued interest due under an unsecured promissory note maturing on January 1, 2023, as amended in November 2021, and a $0.9 million loan granted pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), which matures on May 2, 2022. The Company expects to continue to incur significant operational expenses and net losses in the upcoming 12 months. These factors could, without future consideration of the following events, raise substantial doubt about the Company’s ability to continue as a going concern.

In October 2021 and November 2021, the Company sold 1,773,974 shares of common stock under its "at-the-market" equity offering program (the "ATM Offering"). The Company received $3.5 million in net proceeds from the ATM Offering.

On November 16, 2021, the Company received $10.0 million in net proceeds from issuance of an unsecured promissory note with a face amount of $10.2 million. The note bears interest at a rate of 9.5% per annum compounding daily, matures January 1, 2023, 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.

On November 16, 2021, the Company also entered into a note amendment (the “Note Amendment”) to a note dated November 4, 2020 (the “2020 Note”) in the original principal amount of $10.2 million. The Note Amendment amended the 2020 Note to, among other things, (i) extend the maturity date to January 1, 2023, (ii) increase the interest rate from 7.5% per annum to 10% per annum compounding daily beginning on January 1, 2022 and (iii) provide for the lender’s right to redeem some or all of the outstanding balance of the 2020 Note for shares of the Company’s common stock beginning July 1, 2022, subject to certain limitations.

In November 2021, the Company issued in an underwritten public offering of 46,000,000 shares of common stock at a purchase price per share of $1.25 for $54.0 million in net proceeds after payment of underwriter discounts and commissions

and other underwriter offering costs. GMS Ventures and Investments (“GMS Ventures”), an affiliate of BioLexis Pte. Ltd. (“BioLexis”), the Company’s largest stockholder and strategic partner, purchased an aggregate of 16,000,000 shares of common stock in the public offering at the public offering price per share. In connection with the underwritten public offering the Company issued the underwriter warrants to purchase up to an aggregate of 2,100,000 shares of common stock at an exercise price of $1.5625 per share, which warrants have a 5-year term.

The Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that the Company’s existing cash and cash equivalents as of September 30, 2021 together with the $3.5 million in net proceeds from the sale of shares of common stock under the ATM Offering in October 2021 and November 2021, $10.0 million in net proceeds from issuance of an unsecured promissory note in November 2021, and net proceeds of $54.0 million received in November 2021 from the public offering are expected to fund its operations through the anticipated approval of the ONS-5010 BLA expected in the first calendar quarter of 2023, at least one year from the issuance date of this report. The Company does not anticipate making any material capital expenditures in fiscal 2022 as management believes its facilities and equipment held as of September 30, 2021 are sufficient for at least twelve months subsequent to the date of filing this report.

Basis of Presentation and Summary of Significant Accounting Policies

12 Months Ended

Sep. 30, 2021

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 statements of operations as they occur.

Cash and cash equivalents

Cash and cash equivalents include cash-on-hand and demand deposits with financial institutions and other short-term investments with maturities of less than three months when acquired and convertible to known cash amounts. At September 30, 2021 and 2020, the Company’s cash equivalents consist of a money market account.

Equity method investment

The Company accounts for equity investments where it owns a non-controlling interest, but has the ability to exercise significant influence, under the equity method of accounting. Under the equity method of accounting, the original cost of the investment is adjusted for the Company’s share of equity in the earnings or loss of the equity investee and reduced by dividends and distributions of capital received, unless the fair value option is elected, in which case the investment balance is marked to fair value each reporting period and the impact of changes in fair value of the equity investment are reported in earnings. The Company has not elected the fair value option. The Company assesses its investment for other-than-temporary impairment when events or changes in circumstances indicate that the carrying amount of the investment might not be recoverable and recognize an impairment loss to adjust the investment to its then-current fair value.

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, 2021 and 2020, the Company’s financial instruments included cash, accounts payable, accrued expenses, equipment loans, stockholder notes and the PPP loan under the CARES Act. The carrying amount of accounts payable, accrued expenses, equipment loans, stockholder notes, and the PPP loan approximates fair value due to the short-term maturities of these instruments.

Fair Value of Other Financial Instruments

As of September 30, 2021, the carrying value of the unsecured promissory note of $10.9 million approximates fair value due to the short maturity of this instrument.

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 during the year ended September 30, 2020, which is described more fully in Note 5.

Leases

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, 2021.

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.

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.

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, 2021, the Company’s estimate of the amount of cash refund it expects to receive in 2022 for fiscal 2021 eligible spending as part of this incentive program was $0.1 million. As of September 30, 2020, the Company had a receivable of $0.8 million which was received in fiscal 2021 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, 2021 and 2020, the refundable GST on expenses incurred with Australian vendors was immaterial.

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, 2021 and 2020, the Company recorded $0.1 million and $0.5 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, performance-based stock options and units, and 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, 2021 and 2020, as they would be antidilutive:


	As of September 30,
	2021	2020
Performance-based stock units	2,470	2,470
Performance-based stock options	1,000,000	—
Stock options	16,110,015	3,762,143
Common stock warrants	5,128,829	7,051,854

Recently issued accounting pronouncements

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 Company adopted ASU 2018-13 on October 1, 2020 and the adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

In January 2020, FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815), which, generally, provides guidance for investments in entities accounted for under the equity method of accounting. ASU 2020-01 is effective for all entities with fiscal years beginning after December 15, 2020, including interim periods therein. The Company is currently evaluating the impact of adopting this guidance to its consolidated financial statements.

Fair Value Measurements

12 Months Ended

Sep. 30, 2021

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, 2021
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	522,918

	September 30, 2020
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	70,772

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, 2021 and 2020:


			Redemption
	Warrants		Feature
Balance at October 1, 2019	$	255,734	$	—
Addition of feature on December 20, 2019		—		8,264,451
Change in fair value		(184,962)		(1,796,982)
Write off due to extinguishment of senior secured notes		—		(6,467,469)
Balance at September 30, 2020		70,772		—
Change in fair value		452,146		—
Balance at September 30, 2021	$	522,918	$	—

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,
	2021			2020
Risk-free interest rate		0.62	%		0.24	%
Remaining contractual term of warrant (years)		3.4			4.4
Expected volatility		124.7	%		94.7	%
Annual dividend yield		—	%		—	%
Fair value of common stock (per share)	$	2.17		$	0.72

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.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Property and Equipment

12 Months Ended

Sep. 30, 2021

Property and Equipment

Property and Equipment

5. Property and Equipment

Property and equipment, net, consists of:


	September 30,
	2021		2020
Laboratory equipment	$	1,067,351	$	1,067,351
Less: accumulated depreciation		(903,726)		(740,102)
	$	163,625	$	327,249

Depreciation expense for the years ended September 30, 2021 and 2020 was $163,624 and $219,416, respectively.

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.

Other Assets

12 Months Ended

Sep. 30, 2021

Other Assets.

Other Assets

6. Other Assets

Other assets consist of:


	September 30,
	2021		2020
Investment in PRC joint venture	$	—	$	900,000
Other assets		174,590		394,448
	$	174,590	$	1,294,448

In connection with the execution of a stock purchase agreement with Syntone Ventures LLC (“Syntone Ventures”), the U.S. based affiliate of Syntone Technologies Group Co. Ltd. (“Syntone PRC”) on May 22, 2020, the Company and Syntone PRC entered into a joint venture agreement pursuant to which they agreed to form a People’s Republic of China (“PRC”) joint venture, Beijing Syntone Biopharma Ltd (“Syntone”), that is 80% owned by Syntone PRC and 20% owned by the Company. As the Company can exert significant influence over, but does not control, Syntone’s operations through voting rights or representation on Syntone’s board of directors, the Company accounts for this investment using the equity method of accounting. Upon formation of Syntone in April 2021, the Company entered into a royalty-free license with Syntone for the development, commercialization and manufacture of 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 which was included in other assets at September 30, 2020. Upon formation of Syntone in April 2021, the Company reclassified the investment to equity method investment in the accompanying consolidated balance sheets. The Company expects to be required to make an additional capital contribution to Syntone 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. The maximum exposure to a loss as a result of the Company’s involvement in Syntone is limited to the initial investment and the future capital contributions of approximately $2.1 million.

Accrued Expenses

12 Months Ended

Sep. 30, 2021

Accrued Expenses

Accrued Expenses

7. Accrued Expenses

Accrued expenses consists of:


	September 30,
	2021		2020
Compensation	$	753,808	$	579,618
Severance and related costs		—		9,521
Research and development		808,780		2,890,333
Interest payable		12,909		3,691
Professional fees		—		132,085
Lease termination obligation		—		3,971,111
Other accrued expenses		150,224		170,951
	$	1,725,721	$	7,757,310

Stockholder Notes

12 Months Ended

Sep. 30, 2021

Stockholder Notes

Stockholder Notes

8. Stockholder Notes


	September 30,
	2021		2020
Restricted stock repurchase notes	$	—	$	800,000
Common stock repurchase note		—		2,812,500
		—		3,612,500
Less: current portion		—		(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.

Debt

12 Months Ended

Sep. 30, 2021

Debt

Debt

9. Debt

Debt consists of:


	September 30,
	2021		2020
Unsecured promissory note	$	10,938,145	$	—
Paycheck Protection Program term loan		904,200		904,200
Equipment loans		—		50,285
Total debt		11,842,345		954,485
Less: unamortized loan costs		(52,291)		—
Total debt, net of unamortized loan costs		11,790,054		954,485
Less: current portion		(904,200)		(50,285)
Long-term debt	$	10,885,854	$	904,200

Unsecured promissory note

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. Debt issuance costs totaling $228,032 are recorded as debt discount and are deducted from the principal in the accompanying consolidated balance sheets. The debt discount is amortized as a component of interest expense over the 14-month term of the underlying debt using the effective interest method. The note bears interest at a rate of 7.5% per annum compounding daily and matures January 1, 2023, as amended on November 16, 2021. Refer to Note 2 for further details on the unsecured promissory note amendment. 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. During the year ended September 30, 2021, the Company recognized $893,886 of interest expense related to the unsecured promissory note.

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 began 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. Interest expense on the PPP loan for the years ended September 30, 2021 and 2020 was $9,219 and $3,691, respectively.

Equipment loans

The equipment loans bore 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 were collateralized by the related equipment purchased and an unconditional personal guarantee by the founding stockholder and former chief executive officer. The equipment loans were repaid during the year ended September 30, 2021.

Interest expense on the equipment loans for the years ended September 30, 2021 and 2020 was $3,237 and $8,940, respectively.

Unsecured notes

On March 7, 2019, the Company entered into a forbearance and exchange agreement with Iliad Research and Trading, L.P., a Utah limited partnership (“the Lender”). Concurrent 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. Interest expense on the unsecured notes for the year ended September 30, 2020 was $12,997.

Senior secured notes

In December 2019, the Company entered into an exchange agreement with the holders of its $7,254,077 outstanding aggregate principal amount and accrued interest of senior secured notes (the “Old Senior Notes”) originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017, as amended on April 13, 2017, November 5, 2018, and June 28, 2019 (the “Exchange Agreement”). Pursuant to the Exchange Agreement, the holders of the Old Senior Notes exchanged the entire outstanding principal and accrued interest for new senior secured notes having an aggregate outstanding original principal amount of $7,589,027 which included an aggregate exchange fee of $334,950.

The new senior secured notes were substantially similar to the Old Senior Notes, as amended through the date of the Exchange Agreement, bore interest at a rate of 12.0% per annum and would have matured December 31, 2020 (subject to extension to June 30, 2021 at the Company’s option upon payment of an extension fee equal to 3% of the outstanding balance and being in compliance with applicable Nasdaq listing requirements). The new senior secured notes were convertible, at the option of the holder, beginning April 1, 2020, into shares of the Company’s common stock at a conversion price equal to 90% of the two lowest closing bid prices in the 20 trading days immediately preceding such conversion, subject to a floor price of $0.232 per share. The conversion feature was determined to be a redemption feature and was bifurcated from the debt instrument. The estimated fair value of the redemption feature was $8,264,451 at issuance (see Note 4). The Exchange Agreement was accounted for as an extinguishment of debt. The Company recognized a loss on extinguishment of convertible senior secured notes for the Exchange Agreement during the year ended September 30, 2020 of $8,060,580, which amount was equal to the excess fair value of the notes and bifurcated redemption feature over the notes’ net carrying value.

During the 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 year ended September 30, 2020 was $819,498.

Future maturities of indebtedness at September 30, 2021 are as follows for the years ending September 30:


2022	$	904,200
2023		10,938,145
	$	11,842,345

Commitments and Contingencies

12 Months Ended

Sep. 30, 2021

Commitments and Contingencies.

Commitments and Contingencies

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 $375,011 (based on an exchange rate on September 30, 2021 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 claiming $3,000,000 in damages. On March 30, 2021, the Company entered into a confidential settlement agreement with Liomont, and the complaint was dismissed on April 11, 2021. The Company agreed to make an initial settlement payment of $625,000 that was paid in April 2021; and an additional payment of $750,000, which is contingent upon the occurrence of certain future events.

Leases

Corporate office and warehouse leases

On May 6, 2020, the Company terminated its lease agreement for approximately 66,000 square feet of office, manufacturing and laboratory space located in Cranbury, New Jersey, which previously served as its headquarters, and relocated its corporate office to Monmouth Junction, New Jersey, a site previously used as a warehouse location. 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. In connection with the lease termination, the Company recorded a liability of $981,987 at May 11, 2020, the cease-use date, that represented the undiscounted future termination payments as the termination period was 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.

In March 2021, the Company assigned its Monmouth Junction, New Jersey corporate office lease to a third party and as of September 30, 2021, did not have remaining future obligations. Upon assignment, the Company derecognized the operating lease right-of-use asset and related operating lease liability and recognized a gain of $10,250.

In March 2021, the Company entered into a new three-year term corporate office lease in Iselin, New Jersey which commenced on April 23, 2021.

At September 30, 2020, the lease termination obligation of $356,987 is included in accounts payable on the consolidated balance sheet. A rollforward of the charges incurred to general and administrative expense for the years ended September 30, 2021 and 2020:


	Balance		Expensed / Accrued		Cash		Non-cash		Balance
	October 1, 2020		Expense		Payments		Adjustments		September 30, 2021

Lease termination payments	$	356,987	$	—	$	(356,987)	$	—	$	—


	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)		—		—
Lease termination payments	$	—	$	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 included (i) $287,615 upon execution of the termination agreement, (ii) $50,000 per month for up to 30 months, commencing September 1, 2018, and (iii) a $4.0 million payment, in any event, on or before February 1, 2021. The Company and landlord agreed that the $174,250 security deposit will be used to pay the 7^th, 8^th, 9^th and a portion of the 10^th monthly payments. In November 2020, the Company fully settled the remaining lease termination payments for a one-time cash payment of $3,250,000 and $190,336 security deposit from the terminated Cranbury, New Jersey corporate office lease. Upon settlement, the Company recognized a gain of $542,090 in general and administrative expenses which represented the difference between the carrying value of the liability at the time of settlement and the settlement amounts. At September 30, 2020, the lease termination obligation is included in accrued expenses on the consolidated balance sheets. A rollforward of the charges incurred to general and administrative expense for the years ended September 30, 2021 and 2020 is as follows:


	Balance		Expensed / Accrued		Cash			Non-cash	Balance
	October 1, 2020		Expense		Payments			Adjustments	September 30, 2021

Lease termination payments	$	3,971,111	$	111,315	$	(3,540,336)	$	(542,090)	$	—


	Balance		Expensed /		Cash		Non-cash		Balance
	October 1, 2019		Accrued Expense		Payments		Adjustments		September 30, 2020
Lease termination payments	$	3,909,448	$	661,663	$	(600,000)	$	—	$	3,971,111

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 years ended September 30, 2021 and 2020 were as follows:


	Year ended September 30,
	2021		2020
Lease cost:
Amortization of right-of-use assets	$	—	$	182,967
Interest on lease liabilities		5,093		905,027
Total finance lease cost		5,093		1,087,994
Operating lease cost		106,879		174,500
Total lease cost	$	111,972	$	1,262,494

Amounts reported in the consolidated balance sheets for leases where the Company is the lessee were as follows:


	September 30,
	2021		2020
Operating leases:
Right-of-use asset	$	111,429	$	166,986
Operating lease liabilities		69,849		187,486
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		42,482		72,260
Weighted-average remaining lease term (years):
Operating leases		2.6		1.0
Finance leases		1.7		2.4
Weighted-average discount rate:
Operating leases		7.5%		9.0%
Finance leases		9.5%		8.5%

Other information related to leases for the years ended September 30, 2021 and 2020 are as follows:


	Year ended September 30,
	2021		2020
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	5,093	$	905,027
Operating cash flows from operating leases		158,708		187,500
Financing cash flows from finance leases		29,778		215,074
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	128,473	$	—
Finance leases		—		—

Future minimum payments under noncancelable leases at September 30, 2021 are as follows for the years ending September 30:


	Operating leases		Finance leases
2022	$	46,652	$	29,605
2023		27,675		13,149
2024		—		4,383
Total undiscounted lease payments	$	74,327	$	47,137
Less: Imputed interest		4,478		4,655
Total lease obligations	$	69,849	$	42,482

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, 2021 and 2020, the expense relating to the matching contribution was $40,305 and $48,315, respectively.

Stockholders Equity (Deficit)

12 Months Ended

Sep. 30, 2021

Stockholders' Equity (Deficit)

Stockholders' Equity (Deficit)

11. Stockholders’ Equity (Deficit)

Common stock

In February 2021, the Company issued in an underwritten public offering an aggregate of 38,593,767 shares of common stock at a purchase price per share of $1.00 for $35.5 million in net proceeds after payment of underwriter discounts and commissions and other underwriter offering costs. GMS Ventures purchased an aggregate of 8,360,000 shares of common stock in the public offering at the public offering price per share. In a separate concurrent private placement, the Company issued 3,000,000 shares of common stock to Syntone Ventures at a purchase price of $1.00 per share for aggregate gross proceeds of $3.0 million.

Following partial exercise of the underwriters’ overallotment option subsequent to the initial closing, and pursuant to the Investor Rights Agreement dated as of September 11, 2017 and as amended, by and among the Company, BioLexis and GMS Ventures, the Company sold an additional 1,013,627 shares of common stock to GMS Ventures in a private placement for aggregate gross proceeds to the Company of $1.0 million at the public offering price per share of $1.00.

In connection with the underwritten public offering (including the partial exercise of the overallotment option) the Company issued the underwriter warrants to purchase up to an aggregate of 2,116,364 shares of common stock at an exercise price of $1.25 per share, which warrants have a 5-year term.

On March 24, 2021, following receipt of stockholder approval at the Company’s 2021 annual meeting of stockholders, the number of authorized shares of common stock was increased from 200,000,000 shares to 325,000,000 shares.

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 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.

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, 2020, the Company issued 109 shares of common stock 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, 2021.

H.C. Wainwright & Co. At-the-Market Offering Agreement

On March 26, 2021, the Company entered into an At-the-Market Offering Agreement (the “Agreement”) with H.C. Wainwright & Co., as sales agent (“Wainwright” or the “Agent”), under which the Company may issue and sell shares of its common stock from time to time through Wainwright as sales agent. The Company filed a prospectus supplement, dated March 26, 2021, with the Securities and Exchange Commission pursuant to which the Company may offer and sell shares of common stock having an aggregate offering price of up to up to $40.0 million from time to time through Wainwright. The Company incurred financing costs of $197,654 which were capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company sells common stock under the ATM Offering. As of September 30, 2021, $161,997 of such deferred costs are included in other assets on the consolidated balance sheets.

Under the Agreement, the Company pays Wainwright a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the Agreement. The offering of common stock pursuant to the Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the Agreement or (ii) termination of the Agreement in accordance with its terms.

During the year ended September 30, 2021, the Company sold 2,855,190 shares of common stock under the ATM Offering and generated $7.2 million in gross proceeds. The Company paid fees to the sales agent of $0.2 million.

Common stock warrants

As of September 30, 2021, 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		416,035	$	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		172,864	$	1.27
February 26, 2024		1,747,047	$	0.9535
June 22, 2025		191,268	$	1.51875
January 28, 2026		2,116,364	$	1.25
		5,128,829

(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, 2021, warrants to purchase an aggregate of 3,642,138 shares of common stock with a weighted averaged exercise price of $0.9866 were exercised for aggregate gross proceeds to the Company of $3,593,380. In addition, warrants to purchase an aggregate of 397,251 shares of common stock with a weighted averaged exercise price of $1.51875 were exercised on a cashless basis and the Company issued 173,797 shares of common stock in connection with these cashless exercises.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Section S99
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-Subparagraph (SX 210.3-04)
-URI http://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (d)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-Section 50
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-Paragraph 16
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (i)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496158-112644

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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+ Details

Convertible Preferred Stock

12 Months Ended

Sep. 30, 2021

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, the Company issued an additional 1,661 shares of Series A-1 to settle the related dividends that were due on a quarterly basis.

At September 30, 2021 and 2020, there were no shares of Series A-1 outstanding.

Stock-Based Compensation

12 Months Ended

Sep. 30, 2021

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. As of September 30, 2021, 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 27,838,019. As of September 30, 2021, 10,558,352 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.

The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations for the years ended September 30, 2021 and 2020:


	Year ended September 30,
	2021		2020
Research and development	$	953,328	$	1,241,945
General and administrative		3,933,959		1,565,484
	$	4,887,287	$	2,807,429

Stock options

The following table summarizes all of the Company’s stock option activity for the years ended September 30, 2020 and 2021:


				Weighted
				Average
		Weighted		Remaining
	Number of	Average		Contractual	Aggregate
	Shares	Exercise Price		Term (Years)	Intrinsic Value
Balance at October 1, 2019	1,389,999	$	3.46
Granted	2,641,621		1.33
Forfeited or expired	(269,477)		2.78
Balance at September 30, 2020	3,762,143		2.01
Granted	12,461,645		1.29
Forfeited or expired	(113,773)		0.76
Balance at September 30, 2021	16,110,015		1.46	9.0	$	14,303,576
Vested and exercisable	3,683,874		1.65	8.5	$	3,218,406
Vested and expected to vest at September 30, 2021	16,110,015	$	1.46	9.0

The aggregate intrinsic value represents the total amount by which the fair market 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 and directors for the years ended September 30, 2021 and 2020 was $0.98 and $0.96 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,
	2021		2020
Risk-free interest rate	0.58	%	0.66	%
Expected term (years)	6.04		5.72
Expected volatility	94.5	%	90.5	%
Expected dividend yield	—		—

As of September 30, 2021, there was $11,039,997 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 3.3 years.

Performance-based stock options

During the year ended September 30, 2021, the Company granted an officer of the Company share option awards whose vesting is contingent upon meeting company-wide performance goals, including upon the Company raising $100 million on or prior to the last day of the first calendar quarter of 2022, and upon the Company filing the ONS-5010 BLA on or

prior to the last day of the second calendar quarter of 2022. The performance stock options were granted “at-the-money” and have contractual lives 10 years.

The fair value of each option grant under the performance share option plan was estimated on the date of grant using the same option valuation model used for nonstatutory options above. Compensation expense for performance-based stock options is only recognized when management determines it is probable that the awards will vest.

A summary of the activity under the performance share option plan as of September 30, 2021, and changes during the year then ended is presented below.


				Weighted
				Average
		Weighted		Remaining
	Number of	Average		Contractual	Aggregate
	Shares	Exercise Price		Term (Years)	Intrinsic Value
Balance at October 1, 2020	—	$	—
Granted	1,000,000		2.42
Balance at September 30, 2021	1,000,000		2.42	9.8	$	—
Vested and exercisable	—		—	—	$	—
Vested and expected to vest at September 30, 2021	—	$	—	—

The weighted average grant date fair value of the performance stock options awarded for the year ended September 30, 2021 was $1.76 per option. As of September 30, 2021, the Company assessed that the performance conditions were not probable of achievement. The assessment was based on the relevant facts and circumstances, including the Company historical success rate of financing and bringing developmental drug therapies to market and therefore no compensation costs was recognized. 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, 2021
Risk-free interest rate	0.88	%
Expected term (years)	5.43
Expected volatility	93.1	%
Expected dividend yield	—

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, 2021 and 2020:


				Weighted
				Average
	Number	Base		Remaining
	of	Price		Contractual	Aggregate
	PSUs	Per PSU		Term (Years)	Intrinsic Value
Balance at October 1, 2019	2,470	$	49.97
Forfeitures	—		—
Balance at September 30, 2020	2,470		—
Forfeitures	—		—
Balance at September 30, 2021	2,470		49.97	3.0	$	—
Vested and exercisable at September 30, 2021	2,470		49.97	3.0	$	—
Vested and expected to vest at September 30, 2021	2,470	$	49.97	3.0	$	—

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 year ended September 30, 2020:


		Weighted
	Number	Average
	of	Grant Date
	RSUs	Fair Value
Balance at October 1, 2019	109	$	96.00
Vested and settled	(109)		96.00
Balance at September 30, 2020	—	$	—

There was no RSU activity during the year ended September 30, 2021.

Restricted stock

In January 2020, in connection with the consulting agreements entered into by the Company and four principals of MTTR, the Company issued an aggregate of 7,244,739 shares of its common stock. Refer to Note 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 years ended September 30, 2021 and 2020, the Company recognized compensation expense related to the restricted stock of $607,060 and $1,301,152, respectively. As of September 30, 2021, there was $2,003,948 of unrecognized compensation expense related to the restricted stock.

Collaboration Arrangements

12 Months Ended

Sep. 30, 2021

Collaboration Arrangements

Collaboration Arrangements

14. Collaboration Arrangements

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. Upon formation of the PRC joint venture in April 2021, the Company entered into a royalty-free license with the PRC joint venture for the development, commercialization and manufacture of 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.

Related-Party Transactions

12 Months Ended

Sep. 30, 2021

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 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 $1,089,408 and $1,294,089 during the years ended September 30, 2021 and 2020, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 13). As of September 30, 2021 and 2020, an aggregate $89,762 due to the former MTTR principals as consultants is included in accounts payable in the accompanying consolidated balance sheets.

For other related party transactions during the years ended September 30, 2021 and 2020, refer to the Stockholder Notes (Note 8).

Income Taxes

12 Months Ended

Sep. 30, 2021

Income Taxes

Income Taxes

16. Income Taxes

Income tax benefit for the years ended September 30, 2021 and 2020 consists of the following:


	Year ended September 30,
	2021		2020
State tax	$	2,000	$	(3,269,157)
Foreign tax provision		—		(2,805)
	$	2,000	$	(3,271,962)

During the year ended September 30, 2020, the Company sold New Jersey State net operating losses (“NOLs”) in the amount of $33,335,492, and unused research and development tax credits in the amount of $555,410 resulting in the recognition of income tax benefits of $3,271,157 recorded in the Company’s statement of operations. The Company did not sell any NOLs or unused research and development tax credits during the year ended September 30, 2021.

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,
	2021		2020
U.S. federal statutory rate	(21.0)	%	(21.0)	%
State taxes, net of federal benefit	(7.0)		(6.6)
Sale of New Jersey net operating losses	—		(6.7)
Net operating loss	1.9		6.2
Deferred true-up	—		26.8
Permanent differences	0.4		(0.3)
Research and development credit	(3.7)		3.3
Change in valuation allowance	30.7		(10.0)
Other	(1.3)		(0.2)
Effective income tax rate	(0.0)	%	(8.5)	%

The tax effects of the temporary differences that gave rise to deferred taxes were as follows:


	September 30,
	2021		2020
Deferred tax assets:
Net operating loss carryforwards	$	67,778,970	$	54,836,227
Stock-based compensation		2,168,228		795,216
Lease liability		31,577		52,702
Research and development credit carryforward		8,842,001		6,892,133
Foreign tax credits		2,357,309		2,357,309
Accruals and others		348,605		307,745
Gross deferred tax assets		81,526,690		65,241,332
Less: valuation allowance		(81,449,372)		(65,102,402)
		77,318		138,930
Deferred tax liabilities:
Property and equipment		(45,995)		(91,990)
Right-of-use Assets		(31,323)		(46,940)
Net deferred tax assets	$	—	$	—

As of September 30, 2021, the Company has approximately $282.4 million and $118.2 million of U.S. federal and New Jersey NOLs that will begin to expire in 2030 and 2039, respectively. As of September 30, 2021, the Company has federal and state research and development tax credit carryforwards of $8.1 million and $0.8 million, respectively, available to reduce future tax liabilities which will begin to expire in 2032 and 2033, respectively. As of September 30, 2021, 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, 2021 and 2020. The valuation allowance increased $16.3 million during the year ended September 30, 2021 and decreased $3.9 million during the year ended September 30, 2020.

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, 2021 and 2020 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,
	2021		2020
Balance at beginning of year	$	1,856,629	$	1,859,434
Changes based on tax positions related to the current year		—		(2,805)
Balance at end of year	$	1,856,629	$	1,856,629

The Company does not anticipate material change in the unrecognized tax benefits in the next 12 months. These unrecognized tax benefits, if recognized, would affect the annual effective tax rate. The Company’s income tax returns for the years from 2011 through 2020 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.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Basis of Presentation and Summary of Significant Accounting Policies (Policies)

12 Months Ended

Sep. 30, 2021

Basis of Presentation and Summary of Significant Accounting Policies

Basis of presentation

Cash and cash equivalents

Equity method investment

Use of estimates

Fair value of financial instruments

●

Level 1 — Quoted prices in active markets for identical assets or liabilities.

●

Fair Value of Other Financial Instruments

As of September 30, 2021, the carrying value of the unsecured promissory note of $10.9 million approximates fair value due to the short maturity of this instrument.

Property and equipment

Long-lived assets

Leases

Leases

Stock-based compensation

Incentive and tax receivables

Research and development

Income taxes

Net loss per share

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of September 30, 2021 and 2020, as they would be antidilutive:


	As of September 30,
	2021	2020
Performance-based stock units	2,470	2,470
Performance-based stock options	1,000,000	—
Stock options	16,110,015	3,762,143
Common stock warrants	5,128,829	7,051,854

Recently issued accounting pronouncements

Basis of Presentation and Summary of Significant Accounting Policies (Tables)

12 Months Ended

Sep. 30, 2021

Basis of Presentation and Summary of Significant Accounting Policies

Schedule of dilutive securities excluded from the computation weighted-average shares


	As of September 30,
	2021	2020
Performance-based stock units	2,470	2,470
Performance-based stock options	1,000,000	—
Stock options	16,110,015	3,762,143
Common stock warrants	5,128,829	7,051,854

Fair Value Measurements (Tables)

12 Months Ended

Sep. 30, 2021

Fair Value Measurements

Schedule of assets and liabilities measured at fair value on a recurring basis


	September 30, 2021
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	522,918

	September 30, 2020
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	70,772

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		—
Change in fair value		452,146		—
Balance at September 30, 2021	$	522,918	$	—

Schedule of fair value of the warrant liability


	September 30,
	2021			2020
Risk-free interest rate		0.62	%		0.24	%
Remaining contractual term of warrant (years)		3.4			4.4
Expected volatility		124.7	%		94.7	%
Annual dividend yield		—	%		—	%
Fair value of common stock (per share)	$	2.17		$	0.72

Property and Equipment (Tables)

12 Months Ended

Sep. 30, 2021

Property and Equipment

Schedule of property and equipment


	September 30,
	2021		2020
Laboratory equipment	$	1,067,351	$	1,067,351
Less: accumulated depreciation		(903,726)		(740,102)
	$	163,625	$	327,249

Other Assets (Tables)

12 Months Ended

Sep. 30, 2021

Other Assets.

Schedule of other assets


	September 30,
	2021		2020
Investment in PRC joint venture	$	—	$	900,000
Other assets		174,590		394,448
	$	174,590	$	1,294,448

Accrued Expenses (Tables)

12 Months Ended

Sep. 30, 2021

Accrued Expenses

Schedule of accrued expenses


	September 30,
	2021		2020
Compensation	$	753,808	$	579,618
Severance and related costs		—		9,521
Research and development		808,780		2,890,333
Interest payable		12,909		3,691
Professional fees		—		132,085
Lease termination obligation		—		3,971,111
Other accrued expenses		150,224		170,951
	$	1,725,721	$	7,757,310

Stockholder Notes (Tables)

12 Months Ended

Sep. 30, 2021

Stockholder Notes

Schedule of stockholder notes


	September 30,
	2021		2020
Restricted stock repurchase notes	$	—	$	800,000
Common stock repurchase note		—		2,812,500
		—		3,612,500
Less: current portion		—		(3,612,500)
	$	—	$	—

Debt (Tables)

12 Months Ended

Sep. 30, 2021

Debt

Schedule of debt


	September 30,
	2021		2020
Unsecured promissory note	$	10,938,145	$	—
Paycheck Protection Program term loan		904,200		904,200
Equipment loans		—		50,285
Total debt		11,842,345		954,485
Less: unamortized loan costs		(52,291)		—
Total debt, net of unamortized loan costs		11,790,054		954,485
Less: current portion		(904,200)		(50,285)
Long-term debt	$	10,885,854	$	904,200

Schedule of future maturities of other indebtedness


2022	$	904,200
2023		10,938,145
	$	11,842,345

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

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+ Details

Commitments and Contingencies (Tables)

12 Months Ended

Sep. 30, 2021

Long-term Purchase Commitment [Line Items]

Schedule of lease information

The components of lease cost for the years ended September 30, 2021 and 2020 were as follows:


	Year ended September 30,
	2021		2020
Lease cost:
Amortization of right-of-use assets	$	—	$	182,967
Interest on lease liabilities		5,093		905,027
Total finance lease cost		5,093		1,087,994
Operating lease cost		106,879		174,500
Total lease cost	$	111,972	$	1,262,494

Amounts reported in the consolidated balance sheets for leases where the Company is the lessee were as follows:


	September 30,
	2021		2020
Operating leases:
Right-of-use asset	$	111,429	$	166,986
Operating lease liabilities		69,849		187,486
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		42,482		72,260
Weighted-average remaining lease term (years):
Operating leases		2.6		1.0
Finance leases		1.7		2.4
Weighted-average discount rate:
Operating leases		7.5%		9.0%
Finance leases		9.5%		8.5%

Other information related to leases for the years ended September 30, 2021 and 2020 are as follows:


	Year ended September 30,
	2021		2020
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	5,093	$	905,027
Operating cash flows from operating leases		158,708		187,500
Financing cash flows from finance leases		29,778		215,074
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	128,473	$	—
Finance leases		—		—

Schedule of operating lease future minimum payments

Future minimum payments under noncancelable leases at September 30, 2021 are as follows for the years ending September 30:


	Operating leases		Finance leases
2022	$	46,652	$	29,605
2023		27,675		13,149
2024		—		4,383
Total undiscounted lease payments	$	74,327	$	47,137
Less: Imputed interest		4,478		4,655
Total lease obligations	$	69,849	$	42,482

Schedule of finance lease future minimum payments


	Operating leases		Finance leases
2022	$	46,652	$	29,605
2023		27,675		13,149
2024		—		4,383
Total undiscounted lease payments	$	74,327	$	47,137
Less: Imputed interest		4,478		4,655
Total lease obligations	$	69,849	$	42,482

Cranbury NJ, May 2020 lease termination

Long-term Purchase Commitment [Line Items]

Schedule of future termination payment derecognized


	Balance		Expensed / Accrued		Cash		Non-cash		Balance
	October 1, 2020		Expense		Payments		Adjustments		September 30, 2021

Lease termination payments	$	356,987	$	—	$	(356,987)	$	—	$	—


	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)		—		—
Lease termination payments	$	—	$	680,017	$	(1,165,544)	$	842,514	$	356,987

Cranbury NJ, August 2018 lease termination

Long-term Purchase Commitment [Line Items]

Schedule of future termination payment derecognized


	Balance		Expensed / Accrued		Cash			Non-cash	Balance
	October 1, 2020		Expense		Payments			Adjustments	September 30, 2021

Lease termination payments	$	3,971,111	$	111,315	$	(3,540,336)	$	(542,090)	$	—


	Balance		Expensed /		Cash		Non-cash		Balance
	October 1, 2019		Accrued Expense		Payments		Adjustments		September 30, 2020
Lease termination payments	$	3,909,448	$	661,663	$	(600,000)	$	—	$	3,971,111

Stockholders' Equity (Deficit) (Tables)

12 Months Ended

Sep. 30, 2021

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		416,035	$	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		172,864	$	1.27
February 26, 2024		1,747,047	$	0.9535
June 22, 2025		191,268	$	1.51875
January 28, 2026		2,116,364	$	1.25
		5,128,829

Stock-Based Compensation (Tables)

12 Months Ended

Sep. 30, 2021

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Schedule of stock-based compensation expense


	Year ended September 30,
	2021		2020
Research and development	$	953,328	$	1,241,945
General and administrative		3,933,959		1,565,484
	$	4,887,287	$	2,807,429

Schedule of performance-based stock units activity


				Weighted
				Average
	Number	Base		Remaining
	of	Price		Contractual	Aggregate
	PSUs	Per PSU		Term (Years)	Intrinsic Value
Balance at October 1, 2019	2,470	$	49.97
Forfeitures	—		—
Balance at September 30, 2020	2,470		—
Forfeitures	—		—
Balance at September 30, 2021	2,470		49.97	3.0	$	—
Vested and exercisable at September 30, 2021	2,470		49.97	3.0	$	—
Vested and expected to vest at September 30, 2021	2,470	$	49.97	3.0	$	—

Schedule of restricted stock units activity


		Weighted
	Number	Average
	of	Grant Date
	RSUs	Fair Value
Balance at October 1, 2019	109	$	96.00
Vested and settled	(109)		96.00
Balance at September 30, 2020	—	$	—

Stock options

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

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, 2019	1,389,999	$	3.46
Granted	2,641,621		1.33
Forfeited or expired	(269,477)		2.78
Balance at September 30, 2020	3,762,143		2.01
Granted	12,461,645		1.29
Forfeited or expired	(113,773)		0.76
Balance at September 30, 2021	16,110,015		1.46	9.0	$	14,303,576
Vested and exercisable	3,683,874		1.65	8.5	$	3,218,406
Vested and expected to vest at September 30, 2021	16,110,015	$	1.46	9.0

Schedule of option assumptions


	Year ended September 30,
	2021		2020
Risk-free interest rate	0.58	%	0.66	%
Expected term (years)	6.04		5.72
Expected volatility	94.5	%	90.5	%
Expected dividend yield	—		—

Performance based share options

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

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, 2020	—	$	—
Granted	1,000,000		2.42
Balance at September 30, 2021	1,000,000		2.42	9.8	$	—
Vested and exercisable	—		—	—	$	—
Vested and expected to vest at September 30, 2021	—	$	—	—

Schedule of option assumptions


	Year ended September 30, 2021
Risk-free interest rate	0.88	%
Expected term (years)	5.43
Expected volatility	93.1	%
Expected dividend yield	—

Income Taxes (Tables)

12 Months Ended

Sep. 30, 2021

Income Taxes

Schedule of Income tax expense


	Year ended September 30,
	2021		2020
State tax	$	2,000	$	(3,269,157)
Foreign tax provision		—		(2,805)
	$	2,000	$	(3,271,962)

Schedule of tax expense reconciliation


	Year ended September 30,
	2021		2020
U.S. federal statutory rate	(21.0)	%	(21.0)	%
State taxes, net of federal benefit	(7.0)		(6.6)
Sale of New Jersey net operating losses	—		(6.7)
Net operating loss	1.9		6.2
Deferred true-up	—		26.8
Permanent differences	0.4		(0.3)
Research and development credit	(3.7)		3.3
Change in valuation allowance	30.7		(10.0)
Other	(1.3)		(0.2)
Effective income tax rate	(0.0)	%	(8.5)	%

Schedule of deferred taxes


	September 30,
	2021		2020
Deferred tax assets:
Net operating loss carryforwards	$	67,778,970	$	54,836,227
Stock-based compensation		2,168,228		795,216
Lease liability		31,577		52,702
Research and development credit carryforward		8,842,001		6,892,133
Foreign tax credits		2,357,309		2,357,309
Accruals and others		348,605		307,745
Gross deferred tax assets		81,526,690		65,241,332
Less: valuation allowance		(81,449,372)		(65,102,402)
		77,318		138,930
Deferred tax liabilities:
Property and equipment		(45,995)		(91,990)
Right-of-use Assets		(31,323)		(46,940)
Net deferred tax assets	$	—	$	—

Schedule of reconciliation of unrecognized tax benefits


	Year ended September 30,
	2021		2020
Balance at beginning of year	$	1,856,629	$	1,859,434
Changes based on tax positions related to the current year		—		(2,805)
Balance at end of year	$	1,856,629	$	1,856,629

Liquidity (Details) - USD ($)						1 Months Ended	2 Months Ended	12 Months Ended
Liquidity (Details) - USD ($)	Nov. 16, 2021	Nov. 05, 2020	Jul. 16, 2020	May 04, 2020	Mar. 19, 2020	Nov. 30, 2021	Nov. 30, 2021	Sep. 30, 2021	Sep. 30, 2020	Nov. 04, 2020	Jan. 27, 2020	Mar. 07, 2019
Liquidity
Accumulated deficit								$ (342,883,254)	$ (289,719,906)
Debt carrying amount								11,842,345	954,485
Proceeds from issuance of stock			$ 1,000,000.0			$ 54,000,000.0		46,301,841	35,430,727
Shares issued during period			823,045		7,244,739	46,000,000
Proceeds from debt								10,000,000	904,200
Unamortized discount								$ 52,291
Redemption price (as a percent)	105.00%
Shares Issued, Price Per Share			$ 1.215			$ 1.25	$ 1.25
Class of Warrant or Right, Number of Securities Called by Warrants or Rights						2,100,000	2,100,000	5,128,829			4,657,852
Class of Warrant or Right, Exercise Price of Warrants or Rights						$ 1.5625	$ 1.5625				$ 0.232
Warrants and Rights Outstanding, Term						5 years	5 years
BioLexis Pte. Ltd [Member]
Liquidity
Shares issued during period						16,000,000
Unsecured promissory note
Liquidity
Debt carrying amount								$ 10,938,145
Proceeds from debt	$ 10,000,000.0	$ 10,000,000.0
Original principal amount	$ 10,200,000	$ 10,200,000
Interest rate (as a percent)	9.50%	7.50%
Unamortized discount	$ 200,000	$ 228,032
Redemption price (as a percent)		105.00%
Paycheck Protection Program
Liquidity
Debt carrying amount								904,200	$ 904,200
Proceeds from debt				$ 904,200
Interest rate (as a percent)				1.00%
Unsecured notes
Liquidity
Original principal amount										$ 10,200,000		$ 1,000,000
Interest rate (as a percent)	10.00%									7.50%		12.00%
ATM Offering
Liquidity
Proceeds from issuance of stock							$ 3,500,000	7,200,000
Payment of fees to sales agent								$ 200,000
Shares issued during period							1,773,974	2,855,190

Basis of Presentation and Summary of Significant Accounting Policies - Info (Details) $ in Millions	12 Months Ended
	Sep. 30, 2021 USD ($)	Sep. 30, 2021 AUD ($)	Sep. 30, 2020 USD ($)
New accounting pronouncements
Impairment of property and equipment			$ 527,624
Annual aggregate eligible revenues		$ 20.0
Cash refund receivable	$ 100,000		800,000
Operations related to cash refund	$ 100,000		$ 500,000
Minimum
New accounting pronouncements
Estimated useful lives	3 years	3 years
Maximum
New accounting pronouncements
Estimated useful lives	10 years	10 years
Unsecured promissory note
New accounting pronouncements
Debt fair value	$ 10,900,000

Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
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	2,470
Performance based share options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	1,000,000
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	16,110,015	3,762,143
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	5,128,829	7,051,854

Fair Value Measurements (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Liabilities
Warrant liability	$ 522,918	$ 70,772
Fair value measurements recurring basis \| Level 3
Liabilities
Warrant liability	$ 522,918	$ 70,772

Fair Value Measurements - Changes in fair value (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Common stock warrants
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance, beginning	$ 70,772	$ 255,734
Change in fair value	452,146	(184,962)
Balance, ending	$ 522,918	70,772
Redemption feature
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
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)

Fair Value Measurements - Assumptions (Details)	Sep. 30, 2021 Y $ / shares	Sep. 30, 2020 Y $ / shares
Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	0.62	0.24
Remaining contractual term of warrant
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs \| Y	3.4	4.4
Remaining contractual term of warrant \| Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Redemption feature input	1
Remaining contractual term 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	124.7	94.7
Redemption feature input	130
Fair value of common stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs \| $ / shares	2.17	0.72

Property and Equipment (Details) - USD ($)	12 Months Ended
Property and Equipment (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Property and Equipment
Laboratory equipment	$ 1,067,351	$ 1,067,351
Less: accumulated depreciation	(903,726)	(740,102)
Property and equipment, net	163,625	327,249
Depreciation expense	$ 163,624	219,416
Impairment of property and equipment		$ 527,624

Other Assets (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Other Assets.
Investment in PRC joint venture		$ 900,000
Other assets	$ 174,590	394,448
Total other assets	$ 174,590	$ 1,294,448

Other Assets - Additional information (Details) - USD ($)		1 Months Ended	12 Months Ended
	May 22, 2020	Jun. 30, 2020	Sep. 30, 2020	May 31, 2020
Schedule of Equity Method Investments [Line Items]
Investment in joint venture			$ 900,000
PRC Joint Venture
Schedule of Equity Method Investments [Line Items]
Ownership percentage	20.00%			20.00%
Investment in joint venture		$ 900,000
Expected future investment	$ 2,100,000	$ 2,100,000
Contract period	4 years
Syntone \| PRC Joint Venture
Schedule of Equity Method Investments [Line Items]
Ownership percentage	80.00%			80.00%

Accrued Expenses (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Accrued Expenses
Compensation	$ 753,808	$ 579,618
Severance and related costs		9,521
Research and development	808,780	2,890,333
Interest payable	12,909	3,691
Professional fees		132,085
Lease termination obligation		3,971,111
Other accrued expenses	150,224	170,951
Accrued expenses, total	$ 1,725,721	$ 7,757,310

Stockholder Notes (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Debt Instrument [Line Items]
Stockholder notes		$ 3,612,500
Less: current portion		(3,612,500)
Restricted stock repurchase notes
Debt Instrument [Line Items]
Stockholder notes	$ 800,000	800,000
Restricted stock repurchase notes \| Minimum
Debt Instrument [Line Items]
Interest rate (as a percent)	0.00%
Restricted stock repurchase notes \| Maximum
Debt Instrument [Line Items]
Interest rate (as a percent)	4.00%
Common stock repurchase note
Debt Instrument [Line Items]
Stockholder notes	$ 2,812,500	$ 2,812,500

Debt - Indebtedness Summary (Details) - USD ($)	Nov. 16, 2021	Sep. 30, 2021	Nov. 05, 2020	Sep. 30, 2020
Debt Instrument [Line Items]
Debt carrying amount		$ 11,842,345		$ 954,485
Less: unamortized loan costs		(52,291)
Total debt		11,790,054		954,485
Less: current portion		(904,200)		(50,285)
Long-term debt		10,885,854		904,200
Unsecured promissory note
Debt Instrument [Line Items]
Debt carrying amount		10,938,145
Less: unamortized loan costs	$ (200,000)		$ (228,032)
Paycheck Protection Program
Debt Instrument [Line Items]
Debt carrying amount		$ 904,200		904,200
Equipment loan
Debt Instrument [Line Items]
Debt carrying amount				$ 50,285

Debt - Indebtedness - Information (Details) - USD ($)				12 Months Ended
Debt - Indebtedness - Information (Details) - USD ($)	Nov. 16, 2021	Nov. 05, 2020	May 04, 2020	Sep. 30, 2021	Sep. 30, 2020
Debt Instrument [Line Items]
Proceeds from loan				$ 10,000,000	$ 904,200
Unamortized discount				52,291
Redemption price (as a percent)	105.00%
Unsecured promissory note
Debt Instrument [Line Items]
Proceeds from loan	$ 10,000,000.0	$ 10,000,000.0
Original principal amount	10,200,000	10,200,000
Unamortized discount	$ 200,000	$ 228,032
Debt Instrument, term		14 months
Interest rate (as a percent)	9.50%	7.50%
Redemption price (as a percent)		105.00%
Interest expense				893,886
Paycheck Protection Program
Debt Instrument [Line Items]
Proceeds from loan			$ 904,200
Debt Instrument, term			2 years
Interest rate (as a percent)			1.00%
Interest expense				9,219	3,691
Equipment loan
Debt Instrument [Line Items]
Interest expense				$ 3,237	$ 8,940
Equipment loan \| Minimum
Debt Instrument [Line Items]
Debt Instrument, term				1 year
Interest rate (as a percent)				12.00%
Equipment loan \| Maximum
Debt Instrument [Line Items]
Debt Instrument, term				5 years
Interest rate (as a percent)				16.00%

Debt - Unsecured Notes (Details)		12 Months Ended
Debt - Unsecured Notes (Details)	Mar. 07, 2019 USD ($) item D $ / shares	Sep. 30, 2020 USD ($) $ / shares shares	Nov. 16, 2021	Sep. 30, 2021 USD ($)	Nov. 04, 2020 USD ($)
Debt Instrument [Line Items]
Debt outstanding		$ 954,485		$ 11,790,054
Unsecured notes
Debt Instrument [Line Items]
Original principal amount	$ 1,000,000				$ 10,200,000
Debt outstanding	$ 1,947,133	0
Monthly stated interest rate	2.50%
Interest rate (as a percent)	12.00%		10.00%		7.50%
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 on conversion (in shares) \| shares		1,475,258
Interest expense		$ 12,997
Unsecured notes \| Weighted average
Debt Instrument [Line Items]
Conversion rate per share \| $ / shares		$ 1.05

Debt - Senior Secured (Details)	1 Months Ended	12 Months Ended
Debt - Senior Secured (Details)	Dec. 31, 2019 USD ($) item D $ / shares	Sep. 30, 2020 USD ($) $ / shares shares	Sep. 30, 2021 USD ($)
Debt Instrument [Line Items]
Gain (loss) on extinguishment of debt		$ (1,896,296)
Debt outstanding		954,485	$ 11,790,054
Senior Note Warrants
Debt Instrument [Line Items]
Interest expense		819,498
Old Senior notes
Debt Instrument [Line Items]
Carrying value of notes exchanged	$ 7,254,077
Gain (loss) on extinguishment of debt		(8,060,580)
New Senior secured notes
Debt Instrument [Line Items]
Carrying value of notes exchanged	7,589,027	$ 7,994,494
Bank exchange fee	$ 334,950
Interest rate (as a percent)		12.00%
Extension fee (as a percent)	3.00%
Stock price threshold (as a percent)	90.00%
Number of lowest closing bid prices \| item	2
Trading day threshold \| D	20
Floor price \| $ / shares	$ 0.232
Redemption feature	$ 8,264,451
Gain (loss) on extinguishment of debt		$ 6,164,284
Common stock issued on conversion (in shares) \| shares		12,201,461
Conversion rate per share \| $ / shares		$ 0.66
Debt outstanding		$ 0

Debt - Other Indebtedness Maturities (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Debt
2022	$ 904,200
2023	10,938,145
Total debt	$ 11,842,345	$ 954,485

Commitments and Contingencies (Details) - USD ($)		1 Months Ended	12 Months Ended
Commitments and Contingencies (Details) - USD ($)	Mar. 30, 2021	Apr. 30, 2021	Sep. 30, 2021
Other Commitments [Line Items]
Loss Contingency, Damages Sought, Value			$ 3,000,000
Initial settlement payment		$ 625,000
Additional payment on contingent future events	$ 750,000
Selexis
Other Commitments [Line Items]
Expected future investment			$ 375,011

Commitments and Contingencies - Lease termination (Details)		1 Months Ended		12 Months Ended
	May 11, 2020 USD ($) ft²	Mar. 31, 2021 USD ($)	Aug. 31, 2018 USD ($)	Sep. 30, 2021 USD ($)	Nov. 30, 2020 USD ($)	Sep. 30, 2020 USD ($)
Commitment
Gain (loss) recognized				$ 552,340
Finance leases, Lease obligation				42,482		$ 72,260
Lease termination obligation						3,971,111
Corporate Office Lease, Monmouth Junction, New Jersey
Commitment
Gain (loss) recognized		$ 10,250
Cranbury NJ, May 2020 lease termination
Commitment
Gain (loss) recognized	$ (680,017)
Net rentable area \| ft²	66,000
Lease termination obligation	$ 981,987					$ 356,987
Terms of payment for lease	8 months
Cranbury NJ, August 2018 lease termination
Commitment
Gain (loss) recognized				$ 542,090
Lease termination obligation			$ 5,800,000		$ 3,250,000
Terms of payment for lease			30 months
Amount of execution of termination agreement			$ 287,615
Payment for lease per month			50,000
Lease payment in any event			4,000,000.0
Security deposit			$ 174,250		$ 190,336

Commitments and Contingencies - Lease termination rollforward (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Leases
Balance, beginning	$ 3,971,111
Balance, ending		$ 3,971,111
Cranbury NJ, May 2020 lease termination
Leases
Balance, beginning	356,987
Expensed accrued expense		680,017
Cash payments	(356,987)	(1,165,544)
Non-cash Adjustments		842,514
Balance, ending		356,987
Cranbury NJ, May 2020 lease termination \| Lease termination payments
Leases
Balance, beginning	356,987
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 Adjustments		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 \| Lease termination payments
Leases
Balance, beginning	3,971,111	3,909,448
Expensed accrued expense	111,315	661,663
Cash payments	(3,540,336)	(600,000)
Non-cash Adjustments	$ (542,090)
Balance, ending		$ 3,971,111

Commitments and Contingencies - Lease cost (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Lease cost
Amortization of right-of-use assets		$ 182,967
Interest on lease liabilities	$ 5,093	905,027
Total finance lease cost	5,093	1,087,994
Operating lease cost	106,879	174,500
Total lease cost	$ 111,972	$ 1,262,494
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 - Lease balance sheet (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Leases
Operating leases, Right-of-use asset	$ 111,429	$ 166,986
Operating leases, Lease obligation	69,849	187,486
Finance leases, Lease obligation	$ 42,482	$ 72,260
Operating leases, Weighted-average remaining lease term	2 years 7 months 6 days	1 year
Finance leases, Weighted-average remaining lease term	1 year 8 months 12 days	2 years 4 months 24 days
Operating leases, Weighted-average discount rate (as a percent)	7.50%	9.00%
Finance leases, Weighted-average discount rate (as a percent)	9.50%	8.50%

Commitments and Contingencies - Lease cashflow (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Leases
Operating cash flows from finance leases	$ 5,093	$ 905,027
Operating cash flows from operating leases	158,708	187,500
Financing cash flows from finance leases	29,778	$ 215,074
Right-of-use assets obtained in exchange for operating lease obligations	$ 128,473

Commitments and Contingencies - Lease minimum payments (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Operating leases
2022	$ 46,652
2023	27,675
Total undiscounted lease payments	74,327
Less: Imputed interest	4,478
Total lease obligations	69,849	$ 187,486
Finance leases
2022	29,605
2023	13,149
2024	4,383
Total undiscounted lease payments	47,137
Less: Imputed interest	4,655
Total lease obligations	$ 42,482	$ 72,260

Commitments and Contingencies - Employee Benefit (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Commitments and Contingencies.
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	$ 40,305	$ 48,315

Stockholders' Equity (Deficit) - Common Stock (Details)						1 Months Ended				2 Months Ended	12 Months Ended
Stockholders' Equity (Deficit) - Common Stock (Details)	Mar. 26, 2021 USD ($)	Jul. 16, 2020 USD ($) $ / shares shares	Mar. 19, 2020 item shares	Jan. 27, 2020 individual item $ / shares shares	Sep. 11, 2017 USD ($) $ / shares shares	Nov. 30, 2021 USD ($) $ / shares shares	Feb. 28, 2021 USD ($) $ / shares shares	Jun. 30, 2020 USD ($) $ / shares shares	Feb. 29, 2020 USD ($) $ / shares shares	Nov. 30, 2021 USD ($) $ / shares shares	Sep. 30, 2021 USD ($) $ / shares shares	Sep. 30, 2020 USD ($) shares	Mar. 24, 2021 shares	Mar. 23, 2021 shares	Dec. 23, 2019 $ / shares	Apr. 12, 2019 $ / shares
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Issuance of vested restricted stock units (in shares)												109
Number of share issued		823,045	7,244,739			46,000,000
Shares of common stock issuable upon exercise of warrants				4,657,852		2,100,000				2,100,000	5,128,829
Shares issued, price per share \| $ / shares		$ 1.215				$ 1.25				$ 1.25
Proceeds from issuance of stock \| $		$ 1,000,000.0				$ 54,000,000.0					$ 46,301,841	$ 35,430,727
Exercise price per share \| $ / shares				$ 0.232		$ 1.5625				$ 1.5625
Warrants exercise term						5 years				5 years
Number of shares issued upon vesting of restricted stock units (in shares)												109
Common stock, shares authorized											325,000,000	325,000,000	325,000,000	200,000,000
Number of principals \| item			4
Number of executive officers			2	2
MTTR, LLC ("MTTR")
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued				7,244,739
Number of principals \| item				4
Direct registered offering
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued								8,407,411	7,598,426
Shares of common stock issuable upon exercise of warrants								588,519	3,799,213
Shares issued, price per share \| $ / shares								$ 1.215	$ 1.016
Proceeds from issuance of stock \| $								$ 10,200,000	$ 7,700,000
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							3,000,000	16,000,000	2,460,630
Shares of common stock issuable upon exercise of warrants									1,230,315
Shares issued, price per share \| $ / shares							$ 1.00	$ 1.00	$ 1.016
Proceeds from issuance of stock \| $							$ 3,000,000.0	$ 16,000,000.0	$ 2,500,000
Exercise price per share \| $ / shares									$ 0.9535
Warrants exercise term									4 years
Placement Agent
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Shares of common stock issuable upon exercise of warrants									531,890
Exercise price per share \| $ / shares									$ 1.27
Warrants exercise term									5 years
Underwritten Public Offering
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued							38,593,767
Shares of common stock issuable upon exercise of warrants							2,116,364
Shares issued, price per share \| $ / shares							$ 1.00
Proceeds from issuance of stock \| $							$ 35,500,000
Exercise price per share \| $ / shares							$ 1.25
Warrants exercise term							5 years
GMS Ventures & Investments
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued					1,013,627		8,360,000
Shares issued, price per share \| $ / shares					$ 1.00
Proceeds from issuance of stock \| $					$ 1,000,000.0
ATM Offering
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued										1,773,974	2,855,190
Proceeds from issuance of stock \| $										$ 3,500,000	$ 7,200,000
Aggregate offering price \| $	$ 40,000,000.0
Amount reclassified on additional paid in capital \| $	$ 197,654
Deferred costs \| $											161,997
Percentage of commission on sale of common stock	3.00%
Payment of fees to sales agent \| $											$ 200,000
Common stock warrants
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued												10,157,050
Shares of common stock issuable upon exercise of warrants											3,642,138
Proceeds from issuance of stock \| $											$ 3,593,380
Exercise price per share \| $ / shares											$ 0.9866				$ 0.2320	$ 2.90

Stockholders' Equity (Deficit) - Warrants (Details) - USD ($)				1 Months Ended	12 Months Ended
	Jul. 16, 2020	Mar. 19, 2020	Jan. 29, 2020	Nov. 30, 2021	Sep. 30, 2021	Sep. 30, 2020	Jan. 27, 2020	Dec. 23, 2019	Apr. 12, 2019
Warrants
Warrants exercise term				5 years
Exercise price per share				$ 1.5625			$ 0.232
Deemed dividend upon modification of warrants						$ 3,140,009
Shares of common stock issuable upon exercise of warrants				2,100,000	5,128,829		4,657,852
Proceeds from issuance of stock	$ 1,000,000.0			$ 54,000,000.0	$ 46,301,841	$ 35,430,727
Net proceeds from warrants			$ 1,100,000
Number of share issued	823,045	7,244,739		46,000,000
Common stock warrants
Warrants
Exercise price per share					$ 0.9866			$ 0.2320	$ 2.90
Shares of common stock issuable upon exercise of warrants					3,642,138
Proceeds from issuance of stock					$ 3,593,380
Number of share issued						10,157,050
Warrant, 15 Months
Warrants
Warrants exercise term								15 months
Warrant, 5 Years
Warrants
Warrants exercise term								5 years
Cashless warrant
Warrants
Exercise price per share					$ 1.51875
Shares of common stock issuable upon exercise of warrants					397,251
Number of share issued					173,797
February 18, 2022
Warrants
Exercise price per share					$ 12.00
Shares of common stock issuable upon exercise of warrants					416,035
December 22, 2024
Warrants
Exercise price per share					$ 12.00
Shares of common stock issuable upon exercise of warrants					277,128
April 13, 2025
Warrants
Exercise price per share					$ 12.00
Shares of common stock issuable upon exercise of warrants					145,686
May 31, 2025
Warrants
Exercise price per share					$ 12.00
Shares of common stock issuable upon exercise of warrants					62,437
February 24, 2025
Warrants
Exercise price per share					$ 1.27
Shares of common stock issuable upon exercise of warrants					172,864
February 26, 2024
Warrants
Exercise price per share					$ 0.9535
Shares of common stock issuable upon exercise of warrants					1,747,047
June 22, 2025
Warrants
Exercise price per share					$ 1.51875
Shares of common stock issuable upon exercise of warrants					191,268
January 28, 2026
Warrants
Exercise price per share					$ 1.25
Shares of common stock issuable upon exercise of warrants					2,116,364
Warrant exercise price $0.232 \| Common stock warrants
Warrants
Exercise price per share						$ 0.232
Shares of common stock issuable upon exercise of warrants						15,085,240
Number of share issued						13,003,414
Warrant exercise price $0.08 \| Common stock warrants
Warrants
Exercise price per share						$ 0.08
Shares of common stock issuable upon exercise of warrants						80,797

Convertible Preferred Stock (Details) - USD ($)				1 Months Ended	12 Months Ended
Convertible Preferred Stock (Details) - USD ($)	Jul. 16, 2020	Mar. 23, 2020	Mar. 19, 2020	Nov. 30, 2021	Sep. 30, 2021	Sep. 30, 2020	Jan. 27, 2020
Convertible Preferred Stock [Line Items]
Shares issued, price per share	$ 1.215			$ 1.25
Shares issued during period	823,045		7,244,739	46,000,000
Exercise price per share				$ 1.5625			$ 0.232
Deemed Dividend, Amendment Of Series A1 Convertible Preferred Stock						$ 10,328,118
Convertible Preferred Stock Series A-1
Convertible Preferred Stock [Line Items]
Convertible preferred stock, shares authorized					200,000	200,000
Shares issued, price per share					$ 100.00
Convertible stock, par value (in dollars per share)					$ 0.01	$ 0.01
Dividend rate					10.00%
Shares issued during period		29,358,621
Number of stock converted		68,112
Conversion rate per share		$ 431.03447263					$ 18.89797
Preferred stock issued to settle dividends (in shares)						1,661
Convertible preferred stock outstanding					0	0

Stock-Based Compensation - Information (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 4,887,287	$ 2,807,429
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 options	$ 0.98	$ 0.96
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
Performance based share options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years
Weighted average grant date fair value of options	$ 1.76
Stock-based compensation expense	$ 0
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	27,838,019
Number of shares available for grant	10,558,352
Term of award	10 years
2015 Equity Incentive Plan \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	1 year
2015 Equity Incentive Plan \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	4 years
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 - Expense (Details) - USD ($)	12 Months Ended
Stock-Based Compensation - Expense (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 4,887,287	$ 2,807,429
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	953,328	1,241,945
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 3,933,959	$ 1,565,484

Stock-Based Compensation - Stock option activity (Details) - Stock options - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Number of Shares
Balance, Beginning (in shares)	3,762,143	1,389,999
Granted (in shares)	12,461,645	2,641,621
Forfeited or expired (in shares)	(113,773)	(269,477)
Balance, Ending (in shares)	16,110,015	3,762,143
Vested and exercisable (in shares)	3,683,874
Vested and expected to vest (in shares)	16,110,015
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 2.01	$ 3.46
Granted (in dollars per share)	1.29	1.33
Forfeited or expired (in dollars per share)		2.78
Forfeited (in dollars per share)	0.76
Balance, Ending (in dollars per share)	1.46	$ 2.01
Vested and exercisable (in dollars per share)	1.65
Vested and expected to vest (in dollars per share)	$ 1.46
Other option information
Balance-Remaining contractual term	9 years
Vested and exercisable-Remaining contractual term	8 years 6 months
Vested and expected to vest-Remaining contractual term	9 years
Aggregate intrinsic value, Vest and expected	$ 14,303,576
Aggregate intrinsic value, Vest and exercisable	$ 3,218,406

Stock-Based Compensation - Option Assumptions (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	0.58%	0.66%
Expected life (years)	6 years 14 days	5 years 8 months 19 days
Expected volatility	94.50%	90.50%
Expected dividend yield	0.00%
Unrecognized compensation expense	$ 11,039,997
Weighted average exercise period of unrecognized compensation	3 years 3 months 18 days
Performance based share options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	0.88%
Expected life (years)	5 years 5 months 4 days
Expected volatility	93.10%
Expected dividend yield	0.00%

Stock-Based Compensation - Performance-Based (Details) - USD ($) $ / shares in Units, $ in Millions	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Performance-based stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years
Number of PSUs
Balance, Beginning	2,470	2,470
Balance, Ending	2,470	2,470
Vested and exercisable	2,470
Vested and expected to vest	2,470
Weighted Average Base Price Per Unit
Balance, Beginning		$ 49.97
Vested and exercisable	$ 49.97
Balance, Ending	49.97
Vested and expected to vest	$ 49.97
Weighted average remaining contractual term, Outstanding	3 years
Weighted average remaining contractual term, Vested and exercisable	3 years
Weighted average remaining contractual term, Vested and expected to vest	3 years
Performance based share options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years
Number of Shares
Granted (in shares)	1,000,000
Balance, Ending (in shares)	1,000,000
Weighted Average Exercise Price
Granted (in dollars per share)	$ 2.42
Balance, Ending (in dollars per share)	$ 2.42
Other option information
Balance-Remaining contractual term	9 years 9 months 18 days
Funds raised threshold for vesting	$ 100
Weighted average grant date fair value of options	$ 1.76

Stock-Based Compensation - Restricted stock units (Details) - Restricted stock units - $ / shares	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Number of RSUs
Balance, Beginning		109
Vested and settled		(109)
Weighted Average Grant Date Fair Value
Balance, Beginning		$ 96.00
Vested and settled		$ 96.00
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 - Restricted stock (Details)				1 Months Ended		12 Months Ended
Stock-Based Compensation - Restricted stock (Details)	Jul. 16, 2020 shares	Mar. 19, 2020 item shares	Jan. 27, 2020 item shares	Nov. 30, 2021 shares	Jan. 31, 2020 item $ / shares shares	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of principals \| item		4
Shares issued during period \| shares	823,045	7,244,739		46,000,000
Stock-based compensation expense \| $						$ 4,887,287	$ 2,807,429
MTTR, LLC ("MTTR")
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of principals \| item			4
Shares issued during period \| shares			7,244,739
Restricted Stock \| MTTR, LLC ("MTTR")
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of principals \| item					4
Shares issued during period \| shares					7,244,739
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 \| $						607,060	$ 1,301,152
Unamortized expense to be recognized of stock awards other than options \| $						$ 2,003,948
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 (Details) - USD ($)		1 Months Ended	12 Months Ended
Collaboration Arrangements (Details) - USD ($)	May 22, 2020	Jun. 30, 2020	Sep. 30, 2020	May 31, 2020
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Investment in joint venture			$ 900,000
PRC Joint Venture
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Ownership percentage	20.00%			20.00%
Investment in joint venture		$ 900,000
Milestone payments amount	$ 2,100,000	$ 2,100,000
Period over which additional investment in joint venture will be made		4 years
Syntone \| PRC Joint Venture
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Ownership percentage	80.00%			80.00%

Related-Party Transactions (Details)				1 Months Ended	12 Months Ended
Related-Party Transactions (Details)	Jul. 16, 2020 shares	Mar. 19, 2020 item shares	Jan. 27, 2020 USD ($) individual item shares	Nov. 30, 2021 shares	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)
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		46,000,000
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					$ 1,089,408	$ 1,294,089
Due to related party, current					$ 89,762	$ 89,762

- Definition

Carrying amount as of the balance sheet date of obligations due all related parties. For classified balance sheets, represents the current portion of such liabilities (due within one year or within the normal operating cycle if longer).

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
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-Subparagraph (SX 210.13-02(a)(4)(iii)(C))
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
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-Name Accounting Standards Codification
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+ Details

- Definition

Direct costs arising from transactions with related parties who are not affiliates or joint Ventures. These costs are categorized as cost of goods sold.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 10
-Section S99
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-Publisher FASB
-Name Accounting Standards Codification
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-SubTopic 10
-Section S99
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442552-122756

+ Details

Income Taxes (Details) - USD ($)	12 Months Ended
Income Taxes (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Income Taxes
State tax	$ 2,000	$ (3,269,157)
Foreign tax provision		(2,805)
Income tax benefit	$ 2,000	$ (3,271,962)

Income Taxes - Reconciliation tax expense (Details)		1 Months Ended	12 Months Ended
Income Taxes - Reconciliation tax expense (Details)	Jan. 01, 2018	Dec. 31, 2017	Sep. 30, 2021	Sep. 30, 2020
Income Taxes
U.S. federal statutory rate	(21.00%)	(34.00%)	(21.00%)	(21.00%)
State taxes, net of federal benefit			(7.00%)	(6.60%)
Sale of New Jersey net operating losses				(6.70%)
Net operating loss			1.90%	6.20%
Deferred true-up				26.80%
Permanent differences			0.40%	(0.30%)
Research and development credit			(3.70%)	3.30%
Change in valuation allowance			30.70%	(10.00%)
Other			(1.30%)	(0.20%)
Effective income tax rate			0.00%	(8.50%)

Income Taxes - Deferred (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Deferred tax assets
Net operating loss carryforwards	$ 67,778,970	$ 54,836,227
Stock-based compensation	2,168,228	795,216
Lease liability	31,577	52,702
Research and development credit carryforward	8,842,001	6,892,133
Foreign tax credits	2,357,309	2,357,309
Accruals and others	348,605	307,745
Gross deferred tax assets	81,526,690	65,241,332
Less: valuation allowance	(81,449,372)	(65,102,402)
Deferred tax assets net of valuation allowance	77,318	138,930
Deferred tax liabilities:
Property and equipment	(45,995)	(91,990)
Right-of-use Assets	$ (31,323)	$ (46,940)

Income Taxes - Additional information (Details) - USD ($)		1 Months Ended	12 Months Ended
	Jan. 01, 2018	Dec. 31, 2017	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2019
Operating Loss Carryforwards [Line Items]
Recognition of income tax benefits			$ 2,000	$ (3,271,962)
Foreign tax credit carryforwards			2,357,309	2,357,309
Unrecognized tax benefits			1,856,629	1,856,629	$ 1,859,434
Increase (decrease) in valuation allowance			$ 16,300,000	$ (3,900,000)
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
Tax credit carryforward				555,410
Recognition of income tax benefits				$ (3,271,157)
Federal
Operating Loss Carryforwards [Line Items]
NOL carryforwards			$ 282,400,000
Tax credit carryforward			8,100,000
State
Operating Loss Carryforwards [Line Items]
NOL carryforwards			118,200,000
Tax credit carryforward			800,000
Foreign
Operating Loss Carryforwards [Line Items]
Tax credit carryforward			2,400,000
Unrecognized tax benefits			$ 1,900,000

Income Taxes - Unrecognized tax benefits (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward]
Balance at beginning of year	$ 1,856,629	$ 1,859,434
Changes based on tax positions related to the current year	0	(2,805)
Balance at end of year	$ 1,856,629	$ 1,856,629