Outlook Therapeutics (OTLK) 10-Q 14 Feb 22 2022 Q1 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	3 Months Ended
	Dec. 31, 2021	Feb. 11, 2022
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Dec. 31, 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	08830
City Area Code	609
Local Phone Number	619-3990
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		224,276,277
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q1
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

Consolidated Balance Sheets - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Current assets:
Cash and cash equivalents	$ 70,150,924	$ 14,477,324
Prepaid expenses and other current assets	7,316,327	7,030,823
Total current assets	77,467,251	21,508,147
Property and equipment, net	122,718	163,625
Operating lease right-of-use assets, net	101,468	111,429
Equity method investment	830,005	853,660
Other assets	156,702	174,590
Total assets	78,678,144	22,811,451
Current liabilities:
Current portion of long-term debt	12,716,269	904,200
Current portion of finance lease liabilities	22,460	26,464
Current portion of operating lease liabilities	44,011	42,854
Accounts payable	2,545,503	2,196,349
Accrued expenses	2,763,646	1,725,721
Income taxes payable	1,856,629	1,856,629
Total current liabilities	19,948,518	6,752,217
Long-term debt (includes debt measured at fair value of $12,213,936 at December 31, 2021)	9,604,391	10,885,854
Finance lease liabilities	13,221	16,018
Operating lease liabilities	15,573	26,995
Warrant liability	273,020	522,918
Total liabilities	29,854,723	18,204,002
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; 224,260,602 shares issued and outstanding at December 31, 2021 and 176,461,628 shares issued and outstanding at September 30, 2021	2,242,606	1,764,616
Additional paid-in capital	403,926,798	345,726,087
Accumulated deficit	(357,345,983)	(342,883,254)
Total stockholders' equity	48,823,421	4,607,449
Total liabilities, convertible preferred stock and stockholders' equity	78,678,144	22,811,451
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 (Pa

Consolidated Balance Sheets (Parentheticals) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Debt measured at fair value	$ 12,213,936
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	224,260,602	176,461,628
Common stock, shares outstanding	224,260,602	176,461,628
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
Unsecured convertible promissory note
Debt measured at fair value	$ 12,213,936

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Operating expenses:
Research and development	$ 9,872,476	$ 11,948,581
General and administrative	3,277,205	2,242,354
Loss from operations	(13,149,681)	(14,190,935)
Loss on equity method investment	23,655
Interest expense, net	351,534	159,663
Loss on extinguishment of debt	1,025,402
Change in fair value of unsecured convertible promissory note	162,355
Change in fair value of warrant liability	(249,898)	105,316
Net loss	$ (14,462,729)	$ (14,455,914)
Per share information:
Net loss per share of common stock, basic (in dollars per share)	$ (0.08)	$ (0.12)
Net loss per share of common stock, diluted (in dollars per share)	$ (0.08)	$ (0.12)
Weighted average shares outstanding, basic (in shares)	188,157,921	121,749,555
Weighted average shares outstanding, diluted (in shares)	188,157,921	121,749,555

Consolidated Statements of Stoc

Consolidated Statements of Stockholders' Equity (Deficit) - USD ($)	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Sep. 30, 2020	$ 1,271,831	$ 291,274,366	$ (289,719,906)	$ 2,826,291
Balance, beginning (in shares) at Sep. 30, 2020	127,183,109
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense		1,154,641		1,154,641
Net loss			(14,455,914)	(14,455,914)
Balance at Dec. 31, 2020	$ 1,271,831	292,429,007	(304,175,820)	(10,474,982)
Balance, ending (in shares) at Dec. 31, 2020	127,183,109
Balance at Sep. 30, 2021	$ 1,764,616	345,726,087	(342,883,254)	4,607,449
Balance, beginning (in shares) at Sep. 30, 2021	176,461,628
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with exercise of stock options	$ 250	17,500		17,750
Issuance of common stock in connection with exercise of stock options (in shares)	25,000
Sale of common stock, net of issuance costs	$ 477,740	56,979,163		57,456,903
Sale of common stock, net of issuance costs (in shares)	47,773,974
Stock-based compensation expense		1,204,048		1,204,048
Net loss			(14,462,729)	(14,462,729)
Balance at Dec. 31, 2021	$ 2,242,606	$ 403,926,798	$ (357,345,983)	$ 48,823,421
Balance, ending (in shares) at Dec. 31, 2021	224,260,602

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
OPERATING ACTIVITIES
Net loss	$ (14,462,729)	$ (14,455,914)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	50,868	81,116
Loss on extinguishment of debt	1,025,402
Non-cash interest expense	344,716	149,210
Stock-based compensation	1,204,048	1,154,641
Change in fair value of unsecured convertible promissory note	162,355
Change in fair value of warrant liability	(249,898)	105,316
Gain on settlement of lease termination obligation		(732,426)
Loss on equity method investment	23,655
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(285,504)	28,339
Other assets		137,579
Operating lease liability	(10,265)	(45,335)
Accounts payable	169,169	939,353
Accrued expenses	1,037,925	(686,527)
Net cash used in operating activities	(10,990,258)	(13,324,648)
FINANCING ACTIVITIES
Proceeds from the sale of common stock, net of issuance costs	57,654,776
Proceeds from debt	10,000,000	10,000,000
Proceeds from exercise of stock options	17,750
Payments of finance lease obligations	(6,801)	(10,080)
Repayment of debt	(401,867)	(3,624,774)
Payment of financing costs	(600,000)	(8,032)
Net cash provided by financing activities	66,663,858	6,357,114
Net increase (decrease) in cash and cash equivalents	55,673,600	(6,967,534)
Cash and cash equivalents at beginning of period	14,477,324	12,535,986
Cash and cash equivalents at end of period	70,150,924	5,568,452
Supplemental disclosure of cash flow information
Cash paid for interest	20,155	$ 10,722
Supplemental schedule of non-cash financing activities:
Common stock issuance costs in accounts payable	179,985
Deferred offering costs amortization	$ 17,888

Organization and Description of

Organization and Description of Business	3 Months Ended
	Dec. 31, 2021
Organization and Description of Business
Organization and Description of Business	1. Organization and Description of Business Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010, started operations in July 2011, 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 novel coronavirus (“COVID-19”) pandemic and its impact globally. Given the Company’s current infrastructure needs and current strategy, the Company was able to transition to remote working with limited impact on productivity, as shelter-in-place and similar government orders were imposed. All 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 three months ended December 31, 2021 were not significantly impacted by COVID-19. ​

Liquidity

Liquidity	3 Months Ended
	Dec. 31, 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 $357,345,983 as of December 31, 2021. As of December 31, 2021, the Company had $22,056,670 of principal and accrued interest due under unsecured promissory notes maturing on January 1, 2023, and a $502,333 loan granted pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), which matures on May 2, 2022. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Management believes that the Company’s existing cash and cash equivalents as of December 31, 2021 will be sufficient to fund its operations through the anticipated approval of the ONS-5010 BLA expected in the first calendar quarter of 2023. Substantial additional financing will be needed by the Company to fund its operations in the future and to commercially develop ONS-5010 and any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include but are not limited to proceeds from potential licensing and/or marketing arrangements with pharmaceutical companies, the issuance of equity securities, and the issuance of additional debt, potential collaborations and revenues from potential future product sales, if any. There can be no assurance that these future funding efforts will be successful. The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to complete revenue-generating partnerships with pharmaceutical companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately (v) regulatory approval and market acceptance of the Company’s proposed future products.

Basis of Presentation and Summa

Basis of Presentation and Summary of Significant Accounting Policies	3 Months Ended
	Dec. 31, 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 unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of December 31, 2021 and its results of operations for the three months ended December 31, 2021 and 2020, cash flows for the three months ended December 31, 2021 and 2020, and stockholders’ equity (deficit) for the three months ended December 31, 2021 and 2020. Operating results for the three months ended December 31, 2021, are not necessarily indicative of the results that may be expected for the full year ending September 30, 2022. The unaudited interim consolidated financial statements presented herein do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 23, 2021. Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, including as a result of the ongoing COVID-19 pandemic, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary. Fair value option As permitted under ASC 825, Financial Instruments Net loss per share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Potentially dilutive securities include warrants, performance-based stock options and units, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following table sets forth the computation of basic loss per share and diluted loss per share: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Net loss attributable to common stockholders ​ $ (14,462,729) ​ $ (14,455,914) Common stock shares outstanding (weighted average) ​ ​ 188,157,921 ​ ​ 121,749,555 Basic and diluted net loss per share ​ $ (0.08) ​ $ (0.12) ​ The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of December 31, 2021 and 2020, as they would be antidilutive: ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ 2021 2020 Performance-based stock units ​ 2,470 ​ 2,470 Performance-based stock options ​ 1,900,000 ​ — Stock options ​ 17,904,189 ​ 11,977,677 Common stock warrants ​ 7,228,829 ​ 7,051,854 ​ Recently issued accounting pronouncements 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) ​ In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) — Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity.

Fair Value Measurements

Fair Value Measurements	3 Months Ended
	Dec. 31, 2021
Fair Value Measurements
Fair Value Measurements	4. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1 - Quoted prices in active markets for identical assets or liabilities. ● Level 2 - Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The following table presents the Company’s liabilities that are measured at fair value on a recurring basis: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 ​ (Level 1) (Level 2) (Level 3) Liabilities ​ ​ ​ ​ ​ ​ ​ ​ ​ Unsecured convertible promissory note ​ $ — ​ $ — ​ $ 12,213,936 Warrant liability ​ ​ — ​ ​ — ​ ​ 273,020 ​ ​ $ — ​ $ — ​ $ 12,486,956 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2021 ​ ​ (Level 1) (Level 2) (Level 3) Liabilities ​ ​ ​ ​ ​ ​ ​ ​ ​ Unsecured convertible promissory note ​ $ — ​ $ — ​ $ — Warrant liability ​ ​ — ​ ​ — ​ ​ 522,918 ​ ​ $ — ​ $ — ​ $ 522,918 ​ 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 unsecured convertible promissory note for the three months ended December 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Unsecured Convertible ​ ​ ​ ​ Promissory Note Warrants Balance at October 1, 2021 ​ $ — ​ $ 522,918 Fair value at issuance date ​ ​ 12,051,581 ​ ​ — Change in fair value ​ ​ 162,355 ​ ​ (249,898) Balance at December 31, 2021 ​ $ 12,213,936 ​ $ 273,020 ​ As further described in Note 8, the Company elected the fair value option to account for its amended unsecured convertible promissory note. The fair value of the amended unsecured convertible promissory note at issuance and at December 31, 2021 was estimated using a discounted cash flow model. Significant estimates in the cash flow model include the discount rate and the probability and timing of redemption. ​ The warrants issued in connection with the convertible senior secured notes originally issued pursuant to a certain Note and Warrant Purchase Agreement dated December 22, 2017, 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 ​ September 30, 2021 Risk-free interest rate ​ ​ 0.99 % ​ ​ 0.62 % Remaining contractual term of warrant (years) ​ ​ 3.1 ​ ​ ​ 3.4 ​ Expected volatility ​ ​ 128.3 % ​ ​ 124.7 % Annual dividend yield ​ ​ — % ​ ​ — % Fair value of common stock (per share) ​ $ 1.36 ​ ​ $ 2.17 ​ ​ Fair Value of Other Financial Instruments ​ At December 31, 2021, the carrying value of the PPP loan approximates its fair value due to the short duration to maturity. The fair value and carrying value of the unsecured promissory note included in long-term debt on the consolidated balance sheet on December 31, 2021 was $10,157,000 and $9,604,391, respectively. The estimated fair value was based on discounted expected future cash flows using the prevailing interest rate that is a Level 3 input under the fair value hierarchy.

Property and Equipment, Net

Property and Equipment, Net	3 Months Ended
	Dec. 31, 2021
Property and Equipment, Net
Property and Equipment, Net	5. Property and Equipment, Net Property and equipment, net, consists of: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Laboratory equipment ​ $ 1,067,351 ​ $ 1,067,351 Less: accumulated depreciation ​ ​ (944,633) ​ ​ (903,726) ​ ​ $ 122,718 ​ $ 163,625 ​ Depreciation expense was $40,907 and $40,906 for the three months ended December 31, 2021 and 2020, respectively.

Equity Method Investment

Equity Method Investment	3 Months Ended
	Dec. 31, 2021
Equity Method Investment
Equity Method Investment	6. Equity Method Investment ​ 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 and 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 $2,100,000, 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 $2,100,000.

Accrued Expenses

Accrued Expenses	3 Months Ended
	Dec. 31, 2021
Accrued Expenses
Accrued Expenses	7. Accrued Expenses Accrued expenses consists of: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Compensation ​ $ 1,044,337 ​ $ 753,808 Research and development ​ ​ 1,382,966 ​ ​ 808,780 Interest payable ​ ​ 223 ​ ​ 12,909 Professional fees ​ ​ 189,996 ​ ​ — Other accrued expenses ​ ​ 146,124 ​ ​ 150,224 ​ ​ $ 2,763,646 ​ $ 1,725,721 ​

Debt

Debt	3 Months Ended
	Dec. 31, 2021
Debt
Debt	8. Debt ​ Debt consists of: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Unsecured convertible promissory note (measured at fair value) ​ $ 12,213,936 ​ $ — Unsecured promissory note ​ ​ 10,342,070 ​ ​ 10,938,145 Paycheck Protection Program term loan ​ ​ 502,333 ​ ​ 904,200 Total debt ​ ​ 23,058,339 ​ ​ 11,842,345 Less: unamortized loan costs ​ ​ (737,679) ​ ​ (52,291) Total debt, net of unamortized loan costs ​ ​ 22,320,660 ​ ​ 11,790,054 Less: current portion ​ ​ (12,716,269) ​ ​ (904,200) Long-term debt ​ $ 9,604,391 ​ $ 10,885,854 ​ ​ Unsecured convertible promissory note ​ On November 5, 2020, the Company received $10,000,000 in net proceeds from issuance of an unsecured promissory note with face amount of $10,220,000 which was amended in November 2021. Debt issuance costs totaling $228,032 were recorded as debt discount and were deducted from the principal in the accompanying consolidated balance sheets. The debt discount was amortized as a component of interest expense over the 14-month term of the underlying debt using the effective interest method. The note bore interest at a rate of 7.5% per annum and was due to mature January 1, 2022. 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 entered into a note amendment which, among other things, (i) extended the maturity date to January 1, 2023, (ii) increased the interest rate from 7.5% per annum to 10% per annum beginning on January 1, 2022, and (iii) provided for the lender’s right to redeem some or all of the outstanding balance of the note for shares of the Company’s common stock beginning July 1, 2022, subject to certain limitations. The amendment was accounted for as an extinguishment of the old promissory note. As a result, the Company recorded a loss on debt extinguishment of $1,025,402 which is the difference between the fair value of the amended promissory note and the net carrying value of the old promissory note which includes $26,488 of unamortized debt discount and lender fees of $552,633. The amended promissory note includes redemption options whereby beginning on July 1, 2022, the holder has the option to redeem up to $2,000,000 of outstanding principal and accrued and unpaid interest per calendar month for shares of the Company’s common stock at a redemption price equal to 75% of the lowest closing bid price in the three trading days immediately preceding the date the holder delivers written notice. The Company elected to account for the amended promissory note at fair value (Note 4) and is not required to bifurcate the redemption options as derivatives. Since the redemption options provide the lender with the right to put the total outstanding principal and interest back to the Company within one year from the balance sheet date, the entire amount is classified as a current liability. As of December 31, 2021, the aggregate unpaid principal and interest outstanding and the fair value of the amended promissory note were $11,714,600 and $12,213,936, respectively. ​ Unsecured promissory note ​ On November 16, 2021, the Company received $10,000,000 in net proceeds from issuance of an unsecured promissory note with face amount of $10,220,000. Debt issuance costs totaling $820,000 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 term of the underlying debt using the effective interest method. The note bears interest at a rate of 9.5% per annum compounding daily and matures January 1, 2023. 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 three months ended December 31, 2021 and 2020, the Company recognized $344,716, and $149,210, respectively, of interest expense related to the unsecured promissory notes of which $108,123 and $29,291, respectively, are related to the amortization of debt discount. ​ 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. Aggregate interest expense on the PPP loan for the three months ended December 31, 2021, and 2020 was $1,708 and $2,279, respectively.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Dec. 31, 2021
Commitments and Contingencies.
Commitments and Contingencies	9. Commitments and Contingencies ​ Litigation ​ On July 20, 2020, Laboratorios Liomont S.A. de C.V. (“Liomont”), filed a complaint against the Company in the U.S. District Court of the Southern District of New York alleging certain breach of contract claims under the June 25, 2014 strategic development, license and supply agreement relating to the biosimilar development program for ONS-3010 and ONS-1045 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 ​ In March 2021, the Company assigned its Monmouth Junction, New Jersey corporate office lease to a third party and as of December 31, 2021, did not have remaining future obligations. 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. Equipment leases ​ The Company has equipment leases, with terms between 12 and 36 months, recorded as finance leases. The equipment leases bear interest between 4.0% and 13.0%. ​ Certain lease agreements contain provisions for future rent increases. Payments due under the lease contracts include minimum payments that the Company is obligated to make under the non-cancelable initial terms of the leases as the renewal terms are at the Company’s option. Lease expense is recorded as research and development or general and administrative based on the use of the leased asset. ​ The components of lease cost for the three months ended December 31, 2021 and 2020 are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Lease cost: ​ ​ Amortization of right-of-use assets ​ $ — ​ $ — Interest on lease liabilities ​ 975 ​ 1,782 Total finance lease cost ​ 975 ​ 1,782 Operating lease cost ​ 11,217 ​ 43,625 Total lease cost ​ $ 12,192 ​ $ 45,407 ​ Amounts reported in the consolidated balance sheets for leases where the Company is the lessee are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Operating leases: ​ ​ ​ Right-of-use asset ​ $ 101,468 ​ $ 111,429 Operating lease liabilities ​ 59,584 ​ 69,849 Finance leases: ​ ​ Right-of-use asset ​ $ — ​ $ — Financing lease liabilities ​ 35,681 ​ 42,482 Weighted-average remaining lease term (years): ​ ​ Operating leases ​ ​ 2.3 ​ ​ 2.6 Finance leases ​ 1.6 ​ 1.7 Weighted-average discount rate: ​ ​ Operating leases ​ ​ 7.5% ​ ​ 7.5% Finance leases ​ 10.0% ​ 9.5% ​ Other information related to leases for the three months ended December 31, 2021 and 2020 are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Cash paid for amounts included in the measurement of lease obligations: ​ ​ ​ Operating cash flows from finance leases ​ $ 975 ​ $ 1,782 Operating cash flows from operating leases ​ 11,522 ​ 48,750 Financing cash flows from finance leases ​ 6,801 ​ 10,080 ​ Future minimum lease payments under non-cancelable leases as of December 31, 2021 are as follows for the years ending September 30: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating leases ​ Finance leases 2022 (remaining nine months) ​ $ 35,130 ​ $ 21,830 2023 ​ 27,675 ​ 13,149 2024 ​ — ​ 4,383 Total undiscounted lease payments ​ $ 62,805 ​ $ 39,362 Less: Imputed interest ​ 3,221 ​ 3,681 Total lease obligations ​ $ 59,584 ​ $ 35,681 ​

Common Stock and Stockholders'

Common Stock and Stockholders' Equity (Deficit)	3 Months Ended
	Dec. 31, 2021
Common Stock and Stockholders' Equity (Deficit)
Common Stock and Stockholders' Equity (Deficit)	10. Common Stock and Stockholders’ Equity (Deficit) Common stock In November 2021, the Company issued in an underwritten public offering 46,000,000 shares of common stock at a purchase price per share of $1.25 for $53,968,057 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. 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 $40,000,000 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 December 31, 2021, $144,109 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 three months ended December 31, 2021, the Company sold 1,773,974 shares of common stock under the ATM Offering and generated $3,622,497 in gross proceeds. The Company paid fees to the Agent and other issuance costs of $115,763. Common stock warrants As of December 31, 2021, shares of common stock issuable upon the exercise of outstanding warrants were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Shares of ​ ​ ​ ​ ​ common stock ​ ​ ​ ​ ​ issuable upon ​ ​ ​ ​ ​ exercise of ​ Exercise Price ​ Expiration Date warrants Per Share ​ February 18, 2022 ​ 416,035 ​ $ 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 ​ $ 1.25000 ​ November 23, 2026 ​ 2,100,000 ​ $ 1.56250 ​ ​ ​ 7,228,829 ​ ​ ​ ​ ​ (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 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.

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Dec. 31, 2021
Stock-Based Compensation
Stock-Based Compensation	11. Stock-Based Compensation 2011 Equity Incentive Plan The Company’s 2011 Equity Compensation Plan (the “2011 Plan”) provided for the Company to sell or issue restricted common stock, RSUs, performance-based awards (“PSUs”), cash-based awards or to grant stock options for the purchase of common stock to officers, employees, consultants and directors of the Company. The 2011 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board. The number of shares of common stock reserved for issuance under the 2011 Plan is 106,490. As of December 31, 2021, PSUs representing 2,470 shares of the Company’s common stock were outstanding under the 2011 Plan. Effective with 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 December 31, 2021, 7,839,178 shares remained available for grant under the 2015 Plan. Stock options and RSUs are granted under the Company’s 2015 Plan and generally vest over a period of one The Company recorded stock-based compensation expense in the following expense categories of its statements of operations for the three months ended December 31, 2021 and 2020: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Research and development ​ $ 252,395 ​ $ 239,971 General and administrative ​ ​ 951,653 ​ ​ 914,670 ​ ​ $ 1,204,048 ​ $ 1,154,641 ​ Stock options As of December 31, 2021, options to purchase common stock of the Company outstanding under the 2015 Plan were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Average ​ ​ ​ ​ ​ ​ ​ Weighted ​ Remaining ​ ​ ​ ​ ​ Number of ​ Average ​ Contractual ​ Aggregate ​ Shares Exercise Price Term (Years) Intrinsic Value Balance at October 1, 2021 ​ 16,110,015 ​ $ 1.46 ​ ​ ​ ​ ​ Granted ​ 1,819,174 ​ ​ 1.52 ​ ​ ​ ​ ​ Exercised ​ (25,000) ​ ​ 0.71 ​ ​ ​ ​ ​ Balance at December 31, 2021 ​ 17,904,189 ​ ​ 1.47 ​ 8.9 ​ $ 5,685,350 Exercisable ​ 6,260,614 ​ ​ 1.28 ​ 8.5 ​ $ 2,533,181 Vested and expected to vest at December 31, 2021 ​ 17,904,189 ​ $ 1.47 ​ 8.9 ​ $ 5,685,350 ​ The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. The weighted average grant date fair value of the options awarded to employees for the three months ended December 31, 2021 and 2020 was $1.16 and $0.54 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ ​ ​ 2021 2020 ​ Risk-free interest rate 1.29 % 0.38 % Expected term (years) ​ 6.0 ​ 6.0 ​ Expected volatility ​ 94.3 % 95.4 % Expected dividend yield ​ — ​ — ​ ​ As of December 31, 2021, there was $12,097,871 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 3.17 years. ​ Performance-based stock options ​ The Company granted certain officers of the Company share option awards whose vesting is contingent upon meeting company-wide performance goals. The performance stock options were granted “at-the-money” and have a term of 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 non-statutory 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 December 31, 2021, and changes during the three months 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, 2021 ​ 1,000,000 ​ $ 2.42 ​ ​ ​ ​ ​ Granted ​ 1,900,000 ​ ​ 1.44 ​ ​ ​ ​ ​ Forfeited or expired ​ (1,000,000) ​ ​ 2.42 ​ ​ ​ ​ ​ Balance at December 31, 2021 ​ 1,900,000 ​ $ 1.44 ​ 9.97 ​ $ — Exercisable ​ — ​ $ — ​ — ​ $ — Vested and expected to vest at December 31, 2021 ​ 1,900,000 ​ $ 1.44 ​ 9.97 ​ $ — ​ The weighted average grant date fair value of the performance stock options awarded during the three months ended December 31, 2021, was $1.03 per option. As of December 31, 2021, the Company assessed that the performance conditions were not probable of achievement. The assessment was based on the relevant facts and circumstances 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, 2021 ​ Risk-free interest rate ​ ​ ​ 1.26 % Expected term (years) ​ ​ ​ 5.22 ​ Expected volatility ​ ​ ​ 91.46 ​ Expected dividend yield ​ ​ ​ — % ​ ​ There were no performance-based stock options granted during the three months ended December 31, 2020. ​ Performance-based stock units The Company has issued PSUs, which generally have a ten-year term 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 three months ended December 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Average ​ ​ ​ ​ ​ Number ​ Base ​ Remaining ​ ​ ​ ​ ​ of ​ Price ​ Contractual ​ Aggregate ​ PSUs Per PSU Term (Years) Intrinsic Value Balance at October 1, 2021 ​ 2,470 ​ $ 49.97 ​ ​ ​ ​ ​ Forfeitures ​ — ​ ​ — ​ ​ ​ ​ ​ Balance at December 31, 2021 ​ 2,470 ​ ​ 49.97 ​ 3.0 ​ $ — Vested and exercisable at December 31, 2021 ​ 2,470 ​ ​ 49.97 ​ 3.0 ​ $ — Vested and expected to vest at December 31, 2021 ​ 2,470 ​ $ 49.97 ​ 3.0 ​ $ — ​ Restricted stock In connection with the consulting agreements entered into by the Company and four former principals of MTTR, in March 2020, the Company issued an aggregate of 7,244,739 shares of its common stock. Refer to Note 12 for further details on the consulting agreements and terminated strategic partnership agreement. These 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 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 BLA 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. As of December 31, 2021, 1,811,184 shares of common stock were vested and not subject to repurchase rights. ​ The grant date fair value of the restricted shares was $0.54 per share and equal to the closing stock price of the Company’s common stock at the time of grant. Compensation expense is recognized over the shorter of the explicit service period or derived service period, which was determined to be 4.8 years at the time of grant. Compensation expense may be accelerated when certain performance conditions become probable, and the corresponding purchase right has lapsed. During the three months ended December 31, 2021, and 2020, the Company recognized compensation expense related to the restricted stock of $151,764. As of December 31, 2021, there was $1,700,418 of unrecognized compensation expense related to the restricted stock.

Related-Party Transactions

Related-Party Transactions	3 Months Ended
	Dec. 31, 2021
Related-Party Transactions
Related-Party Transactions	12. Related-Party Transactions MTTR - strategic partnership agreement (ONS-5010) In February 2018, the Company entered into a strategic partnership agreement with MTTR to advise on regulatory, clinical and commercial strategy and assist in obtaining approval of ONS-5010, the Company's bevacizumab therapeutic product candidate for ophthalmic indications. In November 2018, the board of directors of the Company appointed Mr. Terry Dagnon as Chief Operating Officer, and Mr. Jeff Evanson as Chief Commercial Officer. Both Mr. Dagnon and Mr. Evanson initially provided services to the Company pursuant to the February 2018 strategic partnership agreement with MTTR, as amended. Mr. Dagnon and Mr. Evanson were both principals in MTTR. The Company did not pay Mr. Dagnon or Mr. Evanson any direct compensation as consultants or as employees during the three months ended December 31, 2019 nor during the period from October 1, 2019 through March 19, 2020. Both Mr. Dagnon and Mr. Evanson were compensated directly by MTTR for services provided to the Company as the Company's Chief Operating Officer and Chief Commercial Officer, respectively, pursuant to the strategic partnership agreement until such agreement, as amended, was terminated effective March 19, 2020. The Company began compensating Mr. Dagnon and Mr. Evanson directly as consultants effective March 19, 2020 pursuant to their respective consulting agreements with the Company, which became effective March 19, 2020 following stockholder approval of the share issuances contemplated therein. ​ On January 27, 2020, the Company entered into a termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Pursuant to the agreement, the Company agreed (x) to issue to the four principals of MTTR (who include two of its named executive officers, Messrs. Dagnon and Evanson), an aggregate of 7,244,739 shares of its common stock, subject to stockholder approval, (y) to enter into consulting agreements with each of the four principals setting forth the terms of his respective compensation arrangement, and (z) to pay MTTR a one-time settlement fee of $110,000, upon effectiveness of the agreement. ​ Concurrently, the Company also entered into consulting agreements directly with each of the four principals of MTTR setting forth the terms of his respective compensation arrangement, as well as providing for certain transfer restrictions and repurchase rights applicable to the shares of common stock to be issued pursuant hereto. The termination agreement, and the consulting agreements, became effective upon stockholder approval of the share issuance on March 19, 2020. Refer to Note 11 for the accounting of the restricted stock issued and compensation expense recognized. ​ During the three months ended December 31, 2021 and 2020, MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate $313,986 and $467,653 , respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 11). As of December 31, 2021, and September 30, 2021 an aggregate $91,283 and $89,762 , respectively, was due to the former MTTR principals as consultants, which is included in accounts payable in the accompanying consolidated balance sheets. ​ On December 21, 2021, we entered into employment agreements with each of Mr. Dagnon and Mr. Evanson, which superseded and replaced their prior consulting agreements. Pursuant to their new employment agreements, each of Mr. Dagnon and Mr. Evanson will receive a base salary of $450,000 and a discretionary annual cash bonus with a target amount equal to 50% of his respective base salary. In connection with their entry into the employment agreements, each of Mr. Dagnon and Mr. Evanson received a grant of 800,000 options to purchase common stock, one quarter of which will vest on the first anniversary of the grant and the remainder of which will vest in monthly installments over the succeeding three years, subject to their continued service through each vesting date. In addition, each of Mr. Dagnon and Mr. Evanson received a performance grant of 200,000 options to purchase common stock, which will vest upon the Company’s achievement of certain milestones.

Basis of Presentation and Sum_2

Basis of Presentation and Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Dec. 31, 2021
Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation	Basis of presentation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of December 31, 2021 and its results of operations for the three months ended December 31, 2021 and 2020, cash flows for the three months ended December 31, 2021 and 2020, and stockholders’ equity (deficit) for the three months ended December 31, 2021 and 2020. Operating results for the three months ended December 31, 2021, are not necessarily indicative of the results that may be expected for the full year ending September 30, 2022. The unaudited interim consolidated financial statements presented herein do not contain the required disclosures under GAAP for annual consolidated financial statements. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended September 30, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 23, 2021.
Use of estimates	Use of estimates The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, including as a result of the ongoing COVID-19 pandemic, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary.
Fair value option	Fair value option As permitted under ASC 825, Financial Instruments
Net loss per share	Net loss per share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Potentially dilutive securities include warrants, performance-based stock options and units, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss. The following table sets forth the computation of basic loss per share and diluted loss per share: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Net loss attributable to common stockholders ​ $ (14,462,729) ​ $ (14,455,914) Common stock shares outstanding (weighted average) ​ ​ 188,157,921 ​ ​ 121,749,555 Basic and diluted net loss per share ​ $ (0.08) ​ $ (0.12) ​ The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of December 31, 2021 and 2020, as they would be antidilutive: ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ 2021 2020 Performance-based stock units ​ 2,470 ​ 2,470 Performance-based stock options ​ 1,900,000 ​ — Stock options ​ 17,904,189 ​ 11,977,677 Common stock warrants ​ 7,228,829 ​ 7,051,854 ​
Recently issued accounting pronouncements	Recently issued accounting pronouncements 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) ​ In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) — Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity.

Basis of Presentation and Sum_3

Basis of Presentation and Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Dec. 31, 2021
Basis of Presentation and Summary of Significant Accounting Policies
Schedule of computation of basic earnings per share and diluted earnings per share	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Net loss attributable to common stockholders ​ $ (14,462,729) ​ $ (14,455,914) Common stock shares outstanding (weighted average) ​ ​ 188,157,921 ​ ​ 121,749,555 Basic and diluted net loss per share ​ $ (0.08) ​ $ (0.12)
Schedule of dilutive securities excluded from the computation weighted-average shares	​ ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ 2021 2020 Performance-based stock units ​ 2,470 ​ 2,470 Performance-based stock options ​ 1,900,000 ​ — Stock options ​ 17,904,189 ​ 11,977,677 Common stock warrants ​ 7,228,829 ​ 7,051,854 ​

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	3 Months Ended
	Dec. 31, 2021
Fair Value Measurements
Schedule of assets and liabilities measured at fair value on a recurring basis	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 ​ (Level 1) (Level 2) (Level 3) Liabilities ​ ​ ​ ​ ​ ​ ​ ​ ​ Unsecured convertible promissory note ​ $ — ​ $ — ​ $ 12,213,936 Warrant liability ​ ​ — ​ ​ — ​ ​ 273,020 ​ ​ $ — ​ $ — ​ $ 12,486,956 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2021 ​ ​ (Level 1) (Level 2) (Level 3) Liabilities ​ ​ ​ ​ ​ ​ ​ ​ ​ Unsecured convertible promissory note ​ $ — ​ $ — ​ $ — Warrant liability ​ ​ — ​ ​ — ​ ​ 522,918 ​ ​ $ — ​ $ — ​ $ 522,918
Schedule of changes in the fair value of Level 3 valuation for the warrant liability	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Unsecured Convertible ​ ​ ​ ​ Promissory Note Warrants Balance at October 1, 2021 ​ $ — ​ $ 522,918 Fair value at issuance date ​ ​ 12,051,581 ​ ​ — Change in fair value ​ ​ 162,355 ​ ​ (249,898) Balance at December 31, 2021 ​ $ 12,213,936 ​ $ 273,020 ​
Schedule of fair value of the warrant liability	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 ​ September 30, 2021 Risk-free interest rate ​ ​ 0.99 % ​ ​ 0.62 % Remaining contractual term of warrant (years) ​ ​ 3.1 ​ ​ ​ 3.4 ​ Expected volatility ​ ​ 128.3 % ​ ​ 124.7 % Annual dividend yield ​ ​ — % ​ ​ — % Fair value of common stock (per share) ​ $ 1.36 ​ ​ $ 2.17 ​

Property and Equipment, Net (Ta

Property and Equipment, Net (Tables)	3 Months Ended
	Dec. 31, 2021
Property and Equipment, Net
Schedule of property and equipment	​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Laboratory equipment ​ $ 1,067,351 ​ $ 1,067,351 Less: accumulated depreciation ​ ​ (944,633) ​ ​ (903,726) ​ ​ $ 122,718 ​ $ 163,625

Accrued Expenses (Tables)

Accrued Expenses (Tables)	3 Months Ended
	Dec. 31, 2021
Accrued Expenses
Schedule of accrued expenses	​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Compensation ​ $ 1,044,337 ​ $ 753,808 Research and development ​ ​ 1,382,966 ​ ​ 808,780 Interest payable ​ ​ 223 ​ ​ 12,909 Professional fees ​ ​ 189,996 ​ ​ — Other accrued expenses ​ ​ 146,124 ​ ​ 150,224 ​ ​ $ 2,763,646 ​ $ 1,725,721

Debt (Tables)

Debt (Tables)	3 Months Ended
	Dec. 31, 2021
Debt
Schedule of debt	​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Unsecured convertible promissory note (measured at fair value) ​ $ 12,213,936 ​ $ — Unsecured promissory note ​ ​ 10,342,070 ​ ​ 10,938,145 Paycheck Protection Program term loan ​ ​ 502,333 ​ ​ 904,200 Total debt ​ ​ 23,058,339 ​ ​ 11,842,345 Less: unamortized loan costs ​ ​ (737,679) ​ ​ (52,291) Total debt, net of unamortized loan costs ​ ​ 22,320,660 ​ ​ 11,790,054 Less: current portion ​ ​ (12,716,269) ​ ​ (904,200) Long-term debt ​ $ 9,604,391 ​ $ 10,885,854

Commitments and Contingencies (

Commitments and Contingencies (Tables)	3 Months Ended
	Dec. 31, 2021
Commitments and Contingencies.
Schedule of lease information	​ The components of lease cost for the three months ended December 31, 2021 and 2020 are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Lease cost: ​ ​ Amortization of right-of-use assets ​ $ — ​ $ — Interest on lease liabilities ​ 975 ​ 1,782 Total finance lease cost ​ 975 ​ 1,782 Operating lease cost ​ 11,217 ​ 43,625 Total lease cost ​ $ 12,192 ​ $ 45,407 ​ Amounts reported in the consolidated balance sheets for leases where the Company is the lessee are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2021 September 30, 2021 Operating leases: ​ ​ ​ Right-of-use asset ​ $ 101,468 ​ $ 111,429 Operating lease liabilities ​ 59,584 ​ 69,849 Finance leases: ​ ​ Right-of-use asset ​ $ — ​ $ — Financing lease liabilities ​ 35,681 ​ 42,482 Weighted-average remaining lease term (years): ​ ​ Operating leases ​ ​ 2.3 ​ ​ 2.6 Finance leases ​ 1.6 ​ 1.7 Weighted-average discount rate: ​ ​ Operating leases ​ ​ 7.5% ​ ​ 7.5% Finance leases ​ 10.0% ​ 9.5% ​ Other information related to leases for the three months ended December 31, 2021 and 2020 are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Cash paid for amounts included in the measurement of lease obligations: ​ ​ ​ Operating cash flows from finance leases ​ $ 975 ​ $ 1,782 Operating cash flows from operating leases ​ 11,522 ​ 48,750 Financing cash flows from finance leases ​ 6,801 ​ 10,080
Schedule of operating lease future minimum payments	Future minimum lease payments under non-cancelable leases as of December 31, 2021 are as follows for the years ending September 30: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating leases ​ Finance leases 2022 (remaining nine months) ​ $ 35,130 ​ $ 21,830 2023 ​ 27,675 ​ 13,149 2024 ​ — ​ 4,383 Total undiscounted lease payments ​ $ 62,805 ​ $ 39,362 Less: Imputed interest ​ 3,221 ​ 3,681 Total lease obligations ​ $ 59,584 ​ $ 35,681
Schedule of finance lease future minimum payments	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating leases ​ Finance leases 2022 (remaining nine months) ​ $ 35,130 ​ $ 21,830 2023 ​ 27,675 ​ 13,149 2024 ​ — ​ 4,383 Total undiscounted lease payments ​ $ 62,805 ​ $ 39,362 Less: Imputed interest ​ 3,221 ​ 3,681 Total lease obligations ​ $ 59,584 ​ $ 35,681

Common Stock and Stockholders_2

Common Stock and Stockholders' Equity (Deficit) (Tables)	3 Months Ended
	Dec. 31, 2021
Common Stock and Stockholders' Equity (Deficit)
Schedule of warrants outstanding	As of December 31, 2021, shares of common stock issuable upon the exercise of outstanding warrants were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Shares of ​ ​ ​ ​ ​ common stock ​ ​ ​ ​ ​ issuable upon ​ ​ ​ ​ ​ exercise of ​ Exercise Price ​ Expiration Date warrants Per Share ​ February 18, 2022 ​ 416,035 ​ $ 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 ​ $ 1.25000 ​ November 23, 2026 ​ 2,100,000 ​ $ 1.56250 ​ ​ ​ 7,228,829 ​ ​ ​ ​ ​ (i) The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 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.

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Dec. 31, 2021
Share-based Compensation
Schedule of stock-based compensation expense	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ 2021 2020 Research and development ​ $ 252,395 ​ $ 239,971 General and administrative ​ ​ 951,653 ​ ​ 914,670 ​ ​ $ 1,204,048 ​ $ 1,154,641
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, 2021 ​ 2,470 ​ $ 49.97 ​ ​ ​ ​ ​ Forfeitures ​ — ​ ​ — ​ ​ ​ ​ ​ Balance at December 31, 2021 ​ 2,470 ​ ​ 49.97 ​ 3.0 ​ $ — Vested and exercisable at December 31, 2021 ​ 2,470 ​ ​ 49.97 ​ 3.0 ​ $ — Vested and expected to vest at December 31, 2021 ​ 2,470 ​ $ 49.97 ​ 3.0 ​ $ —
Stock options
Share-based Compensation
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, 2021 ​ 16,110,015 ​ $ 1.46 ​ ​ ​ ​ ​ Granted ​ 1,819,174 ​ ​ 1.52 ​ ​ ​ ​ ​ Exercised ​ (25,000) ​ ​ 0.71 ​ ​ ​ ​ ​ Balance at December 31, 2021 ​ 17,904,189 ​ ​ 1.47 ​ 8.9 ​ $ 5,685,350 Exercisable ​ 6,260,614 ​ ​ 1.28 ​ 8.5 ​ $ 2,533,181 Vested and expected to vest at December 31, 2021 ​ 17,904,189 ​ $ 1.47 ​ 8.9 ​ $ 5,685,350
Schedule of option assumptions	​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, ​ ​ ​ 2021 2020 ​ Risk-free interest rate 1.29 % 0.38 % Expected term (years) ​ 6.0 ​ 6.0 ​ Expected volatility ​ 94.3 % 95.4 % Expected dividend yield ​ — ​ — ​
Performance-based stock options
Share-based Compensation
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, 2021 ​ 1,000,000 ​ $ 2.42 ​ ​ ​ ​ ​ Granted ​ 1,900,000 ​ ​ 1.44 ​ ​ ​ ​ ​ Forfeited or expired ​ (1,000,000) ​ ​ 2.42 ​ ​ ​ ​ ​ Balance at December 31, 2021 ​ 1,900,000 ​ $ 1.44 ​ 9.97 ​ $ — Exercisable ​ — ​ $ — ​ — ​ $ — Vested and expected to vest at December 31, 2021 ​ 1,900,000 ​ $ 1.44 ​ 9.97 ​ $ —
Schedule of option assumptions	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended December 31, 2021 ​ Risk-free interest rate ​ ​ ​ 1.26 % Expected term (years) ​ ​ ​ 5.22 ​ Expected volatility ​ ​ ​ 91.46 ​ Expected dividend yield ​ ​ ​ — %

Liquidity (Details)

Liquidity (Details) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Liquidity
Accumulated deficit	$ 357,345,983	$ 342,883,254
Debt carrying amount	23,058,339	11,842,345
Unsecured promissory notes-aggregate
Liquidity
Debt carrying amount	22,056,670
Paycheck Protection Program
Liquidity
Debt carrying amount	$ 502,333	$ 904,200

Basis of Presentation and Sum_4

Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Basic and diluted earnings per share:
Net loss attributable to common stockholders	$ (14,462,729)	$ (14,455,914)
Basic Earnings Per Share
Weighted average shares outstanding, basic (in shares)	188,157,921	121,749,555
Net loss per share of common stock, basic (in dollars per share)	$ (0.08)	$ (0.12)
Diluted Earnings Per Share
Weighted average shares outstanding, diluted (in shares)	188,157,921	121,749,555
Net loss per share of common stock, diluted (in dollars per share)	$ (0.08)	$ (0.12)

Basis of Presentation and Sum_5

Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares	3 Months Ended
	Dec. 31, 2021	Dec. 31, 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 stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	1,900,000
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	17,904,189	11,977,677
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	7,228,829	7,051,854

Fair Value Measurements (Detail

Fair Value Measurements (Details) - Fair value measurements recurring basis - Level 3 - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Liabilities
Unsecured convertible promissory note	$ 12,213,936	$ 0
Warrant liability	273,020	522,918
Fair value of liabilities	$ 12,486,956	$ 522,918

Fair Value Measurements - Chang

Fair Value Measurements - Changes in fair value (Details)	3 Months Ended
	Dec. 31, 2021USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Change in fair value	$ (162,355)
Unsecured convertible promissory note
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Fair value at issuance date	12,051,581
Change in fair value	162,355
Balance, ending	12,213,936
Warrant liability
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance, beginning	522,918
Change in fair value	(249,898)
Balance, ending	$ 273,020

Fair Value Measurements - Assum

Fair Value Measurements - Assumptions (Details)	Dec. 31, 2021USD ($)$ / shares	Sep. 30, 2021$ / sharesUSD ($)
Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	0.99	0.62
Remaining contractual term of warrant
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs | $	3.1	3.4
Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	128.3	124.7
Annual dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	0	0
Fair value of common stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs | $ / shares	1.36	2.17

Fair Value Measurements - Addit

Fair Value Measurements - Additional Information (Details) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Fair value
Debt fair value	$ 12,213,936
Carrying value	22,320,660	$ 11,790,054
Unsecured promissory note (2021)
Fair value
Debt fair value	10,157,000
Carrying value	$ 9,604,391

Property and Equipment, Net (De

Property and Equipment, Net (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Sep. 30, 2021
Property and Equipment, Net
Laboratory equipment	$ 1,067,351		$ 1,067,351
Less: accumulated depreciation	(944,633)		(903,726)
Property and equipment, net	122,718		$ 163,625
Depreciation expense	$ 40,907	$ 40,906

Equity Method Investment - Synt

Equity Method Investment - Syntone (Details) - PRC Joint Venture - USD ($)	May 22, 2020	Jun. 30, 2020
Schedule of Equity Method Investments [Line Items]
Ownership percentage	20.00%
Investment in joint venture		$ 900,000
Expected future investment	$ 2,100,000
Contract period	4 years
Syntone
Schedule of Equity Method Investments [Line Items]
Ownership percentage	80.00%

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Accrued Expenses
Compensation	$ 1,044,337	$ 753,808
Research and development	1,382,966	808,780
Interest payable	223	12,909
Professional fees	189,996
Other accrued expenses	146,124	150,224
Accrued expenses, total	$ 2,763,646	$ 1,725,721

Debt - Summary (Details)

Debt - Summary (Details) - USD ($)	Dec. 31, 2021	Nov. 16, 2021	Sep. 30, 2021	Nov. 05, 2020
Debt Instrument [Line Items]
Debt carrying amount	$ 23,058,339		$ 11,842,345
Less: unamortized loan costs	(737,679)		(52,291)
Total debt	22,320,660		11,790,054
Less: current portion	(12,716,269)		(904,200)
Long-term debt	9,604,391		10,885,854
Unsecured convertible promissory note
Debt Instrument [Line Items]
Debt carrying amount	12,213,936
Total debt	11,714,600
Unsecured promissory note (2021)
Debt Instrument [Line Items]
Debt carrying amount	10,342,070
Less: unamortized loan costs		$ (820,000)
Total debt	9,604,391
Unsecured promissory note (2020)
Debt Instrument [Line Items]
Debt carrying amount			10,938,145
Less: unamortized loan costs		$ (26,488)		$ (228,032)
Paycheck Protection Program
Debt Instrument [Line Items]
Debt carrying amount	$ 502,333		$ 904,200

Debt - Information (Details)

Debt - Information (Details)	Nov. 16, 2021USD ($)D	Nov. 05, 2020USD ($)	May 04, 2020USD ($)	Dec. 31, 2021USD ($)	Dec. 31, 2020USD ($)	Sep. 30, 2021USD ($)
Debt Instrument [Line Items]
Proceeds from loan				$ 10,000,000	$ 10,000,000
Unamortized discount				737,679		$ 52,291
Gain (loss) on extinguishment of debt				(1,025,402)
Payment of lender fees				600,000	8,032
Debt outstanding				22,320,660		$ 11,790,054
Debt fair value				12,213,936
Unsecured convertible promissory note
Debt Instrument [Line Items]
Interest rate (as a percent)	10.00%
Redemption price (as a percent)	75.00%
Trading day threshold | D	3
Debt outstanding				11,714,600
Debt fair value				12,213,936
Unsecured convertible promissory note | Maximum
Debt Instrument [Line Items]
Carrying value of notes exchanged	$ 2,000,000
Unsecured promissory notes-aggregate
Debt Instrument [Line Items]
Interest expense				344,716	149,210
Amortization of debt issuance costs				108,123	29,291
Unsecured promissory note (2020)
Debt Instrument [Line Items]
Proceeds from loan		$ 10,000,000
Unamortized discount	26,488	$ 228,032
Debt Instrument, term		14 months
Interest rate (as a percent)		7.50%
Gain (loss) on extinguishment of debt	(1,025,402)
Payment of lender fees	552,633
Redemption price (as a percent)		105.00%
Unsecured promissory note (2021)
Debt Instrument [Line Items]
Proceeds from loan	10,000,000
Original principal amount	10,220,000
Unamortized discount	$ 820,000
Interest rate (as a percent)	9.50%
Redemption price (as a percent)	105.00%
Debt outstanding				9,604,391
Debt fair value				10,157,000
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				$ 1,708	$ 2,279

Debt - Stockholder Notes (Detai

Debt - Stockholder Notes (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Debt
Repayment of debt	$ 401,867	$ 3,624,774

Commitments and Contingencies_2

Commitments and Contingencies (Details) - USD ($)	Mar. 30, 2021	Apr. 30, 2021	Dec. 31, 2021
Commitments and Contingencies.
Loss Contingency, Damages Sought, Value			$ 3,000,000
Initial settlement payment		$ 625,000
Additional payment on contingent future events	$ 750,000

Commitments and Contingencies -

Commitments and Contingencies - Lease termination (Details) - USD ($)	Dec. 31, 2021	Sep. 30, 2021	Mar. 31, 2021
Commitment
Finance leases, Lease obligation	$ 35,681	$ 42,482
Corporate Office Lease, Iselin, New Jersey
Commitment
Lease term			3 years

Commitments and Contingencies_3

Commitments and Contingencies - Lease cost (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Lease cost
Interest on lease liabilities	$ 975	$ 1,782
Total finance lease cost	975	1,782
Operating lease cost	11,217	43,625
Total lease cost	$ 12,192	$ 45,407
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_4

Commitments and Contingencies - Lease balance sheet (Details) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Leases
Operating leases, Right-of-use asset	$ 101,468	$ 111,429
Operating leases, Lease obligation	59,584	69,849
Finance leases, Lease obligation	$ 35,681	$ 42,482
Operating leases, Weighted-average remaining lease term	2 years 3 months 18 days	2 years 7 months 6 days
Finance leases, Weighted-average remaining lease term	1 year 7 months 6 days	1 year 8 months 12 days
Operating leases, Weighted-average discount rate (as a percent)	7.50%	7.50%
Finance leases, Weighted-average discount rate (as a percent)	10.00%	9.50%

Commitments and Contingencies_5

Commitments and Contingencies - Lease cashflow (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Leases
Operating cash flows from finance leases	$ 975	$ 1,782
Operating cash flows from operating leases	11,522	48,750
Financing cash flows from finance leases	$ 6,801	$ 10,080

Commitments and Contingencies_6

Commitments and Contingencies - Lease minimum payments (Details) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Operating leases
2022 (remaining nine months)	$ 35,130
2023	27,675
Total undiscounted lease payments	62,805
Less: Imputed interest	3,221
Total lease obligations	59,584	$ 69,849
Finance leases
2022 (remaining nine months)	21,830
2023	13,149
2024	4,383
Total undiscounted lease payments	39,362
Less: Imputed interest	3,681
Total lease obligations	$ 35,681	$ 42,482

Common Stock and Stockholders_3

Common Stock and Stockholders' Equity (Deficit) - Common Stock (Details) - USD ($)	Mar. 26, 2021	Nov. 30, 2021	Dec. 31, 2021
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Shares of common stock issuable upon exercise of warrants			7,228,829
Proceeds from issuance of stock			$ 57,654,776
Underwritten Public Offering
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued		46,000,000
Shares of common stock issuable upon exercise of warrants		2,100,000
Shares issued price (in dollars per share)		$ 1.25
Proceeds from issuance of stock		$ 53,968,057
Exercise price per share		$ 1.5625
Warrants exercise term		5 years
GMS Ventures & Investments
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued		16,000,000
ATM Offering
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued			1,773,974
Proceeds from issuance of stock			$ 3,622,497
Aggregate offering price	$ 40,000,000
Amount reclassified on additional paid in capital	$ 197,654
Deferred costs			144,109
Percentage of commission on sale of common stock	3.00%
Payment of fees to sales agent			$ 115,763

Common Stock and Stockholders_4

Common Stock and Stockholders' Equity (Deficit) - Warrants (Details)	3 Months Ended
	Dec. 31, 2021USD ($)$ / sharesshares
Warrants
Shares of common stock issuable upon exercise of warrants	7,228,829
Proceeds from issuance of stock | $	$ 57,654,776
February 18, 2022
Warrants
Exercise price per share | $ / shares	$ 12
Shares of common stock issuable upon exercise of warrants	416,035
December 22, 2024
Warrants
Exercise price per share | $ / shares	$ 12
Shares of common stock issuable upon exercise of warrants	277,128
April 13, 2025
Warrants
Exercise price per share | $ / shares	$ 12
Shares of common stock issuable upon exercise of warrants	145,686
May 31, 2025
Warrants
Exercise price per share | $ / shares	$ 12
Shares of common stock issuable upon exercise of warrants	62,437
February 24, 2025
Warrants
Exercise price per share | $ / shares	$ 1.27
Shares of common stock issuable upon exercise of warrants	172,864
February 26, 2024
Warrants
Exercise price per share | $ / shares	$ 0.9535
Shares of common stock issuable upon exercise of warrants	1,747,047
June 22, 2025
Warrants
Exercise price per share | $ / shares	$ 1.51875
Shares of common stock issuable upon exercise of warrants	191,268
January 28, 2026
Warrants
Exercise price per share | $ / shares	$ 1.25000
Shares of common stock issuable upon exercise of warrants	2,116,364
November 23, 2026
Warrants
Exercise price per share | $ / shares	$ 1.56250
Shares of common stock issuable upon exercise of warrants	2,100,000

Stock-Based Compensation - Info

Stock-Based Compensation - Information (Details)	3 Months Ended
	Dec. 31, 2021shares
2011 Equity Incentive Plan
Share-based Compensation
Number of shares of common stock reserved for issuance	106,490
2015 Equity Incentive Plan
Share-based Compensation
Aggregate number of common stock authorized for issuance	27,838,019
Number of shares available for grant	7,839,178
Term of award	10 years
2015 Equity Incentive Plan | Minimum
Share-based Compensation
Vesting period	1 year
2015 Equity Incentive Plan | Maximum
Share-based Compensation
Vesting period	4 years

Stock-Based Compensation - Expe

Stock-Based Compensation - Expense (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,204,048	$ 1,154,641
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	252,395	239,971
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 951,653	$ 914,670

Stock-Based Compensation - Stoc

Stock-Based Compensation - Stock option activity (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Other option information
Stock-based compensation expense	$ 1,204,048	$ 1,154,641
Stock options
Number of Shares
Balance, Beginning (in shares)	16,110,015
Granted (in shares)	1,819,174
Exercised (in shares)	(25,000)
Balance, Ending (in shares)	17,904,189
Exercisable (in shares)	6,260,614
Vested and expected to vest (in shares)	17,904,189
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 1.46
Granted (in dollars per share)	1.52
Exercised (in dollars per share)	0.71
Balance, Ending (in dollars per share)	1.47
Exercisable (in dollars per share)	1.28
Vested and expected to vest (in dollars per share)	$ 1.47
Other option information
Balance-Remaining contractual term	8 years 10 months 24 days
Exercisable-Remaining contractual term	8 years 6 months
Vested and expected to vest-Remaining contractual term	8 years 10 months 24 days
Aggregate intrinsic value, Outstanding	$ 5,685,350
Aggregate intrinsic value, Exercisable	2,533,181
Aggregate intrinsic value, Vested and expected to vest	$ 5,685,350
Grant date fair value of options (in dollars per share)	$ 1.16	$ 0.54
Performance-based stock options
Share-based Compensation
Term of award	10 years
Number of Shares
Balance, Beginning (in shares)	1,000,000
Granted (in shares)	1,900,000	0
Forfeited or expired (in shares)	(1,000,000)
Balance, Ending (in shares)	1,900,000
Vested and expected to vest (in shares)	1,900,000
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 2.42
Granted (in dollars per share)	1.44
Forfeited or expired (in dollars per share)	2.42
Balance, Ending (in dollars per share)	1.44
Vested and expected to vest (in dollars per share)	$ 1.44
Other option information
Balance-Remaining contractual term	9 years 11 months 19 days
Vested and expected to vest-Remaining contractual term	9 years 11 months 19 days
Grant date fair value of options (in dollars per share)	$ 1.03
Stock-based compensation expense	$ 0

Stock-Based Compensation - Opti

Stock-Based Compensation - Option Assumptions (Details) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Stock options
Share-based Compensation
Risk-free interest rate	1.29%	0.38%
Expected life (years)	6 years	6 years
Expected volatility	94.30%	95.40%
Expected dividend yield	0.00%	0.00%
Unrecognized compensation expense	$ 12,097,871
Unrecognized compensation exercise period	3 years 2 months 1 day
Performance-based stock options
Share-based Compensation
Risk-free interest rate		1.26%
Expected life (years)		5 years 2 months 19 days
Expected volatility		91.46%
Expected dividend yield		0.00%

Stock-Based Compensation - Non-

Stock-Based Compensation - Non-options (Details) - Performance-based stock units	3 Months Ended
	Dec. 31, 2021$ / sharesshares
Share-based Compensation
Term of award	10 years
Number of PSUs
Balance, Beginning | shares	2,470
Balance, Ending | shares	2,470
Vested and exercisable | shares	2,470
Vested and expected to vest | shares	2,470
Weighted Average Base Price Per Unit
Balance, Beginning | $ / shares	$ 49.97
Balance, Ending | $ / shares	49.97
Vested and exercisable | $ / shares	49.97
Vested and expected to vest | $ / shares	$ 49.97
Weighted average remaining contractual term, Outstanding	3 years
Weighted average remaining contractual term, Vested and exercisable	3 years
Weighted average remaining contractual term, Vested and expected to vest	3 years

Stock-Based Compensation - Rest

Stock-Based Compensation - Restricted stock (Details)	Jan. 27, 2020itemshares	Mar. 31, 2020item$ / sharesshares	Dec. 31, 2021USD ($)shares	Dec. 31, 2020USD ($)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense | $			$ 1,204,048	$ 1,154,641
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
Number of shares vested in period | shares			1,811,184
Grant date fair value of share | $ / shares		$ 0.54
Explicit service period		4 years 9 months 18 days
Stock-based compensation expense | $			$ 151,764	$ 151,764
Unamortized expense to be recognized of stock awards other than options | $			$ 1,700,418
Restricted Stock | MTTR, LLC ("MTTR") | Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Repurchase right lapses on shares (as a percent)		50.00%
Restricted Stock | MTTR, LLC ("MTTR") | Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Repurchase right lapses on shares (as a percent)		100.00%

Related-Party Transactions (Det

Related-Party Transactions (Details)	Dec. 21, 2021USD ($)shares	Jan. 27, 2020USD ($)individualitemshares	Dec. 31, 2021USD ($)shares	Dec. 31, 2020USD ($)shares	Sep. 30, 2021USD ($)
Performance-based stock options
Related Party Transaction [Line Items]
Number of shares granted			1,900,000	0
MTTR, LLC ("MTTR")
Related Party Transaction [Line Items]
Number of principals | item		4
Number Of Executive Officers | individual		2
Shares issued during period		7,244,739
Contract termination settlement fee | $		$ 110,000
Related party expense | $			$ 313,986	$ 467,653
Due to related party, current | $			$ 91,283		$ 89,762
Employment agreement | Terry Dagnon
Related Party Transaction [Line Items]
Base salary | $	$ 450,000
Percentage of cash bonus	50.00%
Employment agreement | Terry Dagnon | Stock option
Related Party Transaction [Line Items]
Number of shares granted	800,000
Employment agreement | Terry Dagnon | Performance-based stock options
Related Party Transaction [Line Items]
Number of shares granted	200,000
Employment agreement | Jeff Evanson
Related Party Transaction [Line Items]
Base salary | $	$ 450,000
Percentage of cash bonus	50.00%
Employment agreement | Jeff Evanson | Stock option
Related Party Transaction [Line Items]
Number of shares granted	800,000
Employment agreement | Jeff Evanson | Performance-based stock options
Related Party Transaction [Line Items]
Number of shares granted	200,000