0001558370-21-007283 | 10-Q | XBRL Viewer

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Document And Entity Information - shares	6 Months Ended
Document And Entity Information - shares	Mar. 31, 2021	May 12, 2021
Document Information [Line Items]
Document Type	10-Q
Document Period End Date	Mar. 31, 2021
Entity Registrant Name	OUTLOOK THERAPEUTICS, INC.
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		173,605,807
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q2
Amendment Flag	false
Common Stock
Document Information [Line Items]
Title of 12(b) Security	Common Stock
Trading Symbol	OTLK
Security Exchange Name	NASDAQ
Series A Warrants
Document Information [Line Items]
Title of 12(b) Security	Series A Warrants
Trading Symbol	OTLKW
Security Exchange Name	NASDAQ

Consolidated Balance Sheets - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Current assets:
Cash	$ 37,168,854	$ 12,535,986
Prepaid expenses and other current assets	6,623,987	5,407,882
Total current assets	43,792,841	17,943,868
Property and equipment, net	245,437	327,249
Operating lease right-of-use assets, net		166,986
Other assets	1,073,536	1,294,448
Total assets	45,111,814	19,732,551
Current liabilities:
Current portion of long-term debt	11,184,734	50,285
Current portion of finance lease liabilities	26,972	29,778
Current portion of operating lease liabilities		187,486
Stockholder notes		3,612,500
Accounts payable	6,332,256	2,394,818
Accrued expenses	4,497,209	7,757,310
Income taxes payable	1,856,629	1,856,629
Total current liabilities	23,897,800	15,888,806
Long-term debt	129,171	904,200
Finance lease liabilities	28,755	42,482
Warrant liability	404,916	70,772
Total liabilities	24,460,642	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; 173,605,807 shares issued and outstanding at March 31, 2021 and 127,183,109 shares issued and outstanding at September 30, 2020	1,736,058	1,271,831
Additional paid-in capital	336,197,455	291,274,366
Accumulated deficit	(317,282,341)	(289,719,906)
Total stockholders' equity	20,651,172	2,826,291
Total liabilities, convertible preferred stock and stockholders' equity	45,111,814	19,732,551
Series A convertible preferred stock
Convertible preferred stock:
Total convertible preferred stock
Series A-1 convertible preferred stock
Convertible preferred stock:
Total convertible preferred stock
Series B convertible preferred stock
Stockholders’ equity:
Preferred stock, value

Consolidated Balance Sheets (Parentheticals) - $ / shares	Mar. 31, 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	173,605,807	127,183,109
Common stock, shares outstanding	173,605,807	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
Series A-1 convertible preferred stock
Convertible stock, par value (in dollars per share)	$ 0.01	$ 0.01
Convertible preferred stock, shares authorized	200,000	200,000
Convertible preferred stock, shares issued	0	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 ($)	3 Months Ended		6 Months Ended
Consolidated Statements of Operations - USD ($)	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Operating expenses:
Research and development	$ 8,529,393	$ 4,383,214	$ 20,477,974	$ 10,230,516
General and administrative	4,095,891	1,957,175	6,338,245	4,293,899
Impairment of property and equipment		423,328		423,328
Total operating expenses	12,625,284	6,763,717	26,816,219	14,947,743
Loss from operations	(12,625,284)	(6,763,717)	(26,816,219)	(14,947,743)
Interest expense, net	250,409	696,151	410,072	1,293,816
Loss on extinguishment of debt				8,060,580
Change in fair value of redemption feature		(1,759,037)		(1,796,982)
Change in fair value of warrant liability	228,828	(764)	334,144	(202,142)
Loss before income taxes	(13,104,521)	(5,700,067)	(27,560,435)	(22,303,015)
Income tax expense	2,000		2,000
Net loss	(13,106,521)	(5,700,067)	(27,562,435)	(22,303,015)
Series A-1 convertible preferred stock dividends and related settlement				(166,133)
Deemed dividend upon modification of warrants		(1,431,406)		(3,140,009)
Deemed dividend upon amendment of the terms of the Series A-1 convertible preferred stock		(10,328,118)		(10,328,118)
Net loss attributable to common stockholders	$ (13,106,521)	$ (17,459,591)	$ (27,562,435)	$ (35,937,275)
Per share information:
Net loss per share of common stock, basic and diluted (in dollars per share)	$ (0.09)	$ (0.36)	$ (0.20)	$ (0.93)
Weighted average shares outstanding, basic and diluted (in shares)	150,730,191	47,895,771	136,080,637	38,849,364

Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($)	Preferred Stock Series A-1 convertible preferred stock	Common Stock MTTR, LLC (“MTTR”)	Common Stock	Additional Paid-in Capital MTTR, LLC (“MTTR”)	Additional Paid-in Capital	Accumulated Deficit	Series A-1 convertible preferred stock	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			$ 14,753		1,533,673			1,548,426
Issuance of common stock in connection with conversion of stockholder notes (in shares)			1,475,258
Sale of common stock, net of issuance costs		$ 72,447	$ 100,591	$ (72,447)	9,096,357			$ 9,196,948
Sale of common stock, net of issuance costs (in shares)		7,244,739	10,059,056
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					664,016			664,016
Net loss						(22,303,015)		(22,303,015)
Balance at Mar. 31, 2020			$ 897,512		255,361,229	(276,783,423)		(20,524,682)
Balance, ending (in shares) at Mar. 31, 2020			89,751,192
Balance at Dec. 31, 2019	$ 5,525,537		$ 384,309		239,766,786	(271,083,356)		(30,932,261)
Balance, beginning (in shares) at Dec. 31, 2019	68,112		38,430,924
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with exercise of warrants			$ 46,579		1,034,043			1,080,622
Issuance of common stock in connection with exercise of warrants (in shares)			4,657,852
Sale of common stock, net of issuance costs		$ 72,447	$ 100,591	$ (72,447)	9,096,357			9,196,948
Sale of common stock, net of issuance costs (in shares)		7,244,739	10,059,056
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					304,539			304,539
Net loss						(5,700,067)		(5,700,067)
Balance at Mar. 31, 2020			$ 897,512		255,361,229	(276,783,423)		(20,524,682)
Balance, ending (in shares) at Mar. 31, 2020			89,751,192
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]
Issuance of common stock in connection with exercise of warrants			$ 38,153		3,547,656			3,585,809
Issuance of common stock in connection with exercise of warrants (in shares)			3,815,304
Sale of common stock, net of issuance costs			$ 426,074		39,091,045			39,517,119
Sale of common stock, net of issuance costs (in shares)			42,607,394
Stock-based compensation expense					2,284,388			2,284,388
Net loss						(27,562,435)		(27,562,435)
Balance at Mar. 31, 2021			$ 1,736,058		336,197,455	(317,282,341)		20,651,172
Balance, ending (in shares) at Mar. 31, 2021			173,605,807
Balance at Dec. 31, 2020			$ 1,271,831		292,429,007	(304,175,820)		(10,474,982)
Balance, beginning (in shares) at Dec. 31, 2020			127,183,109
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with exercise of warrants			$ 38,153		3,547,656			3,585,809
Issuance of common stock in connection with exercise of warrants (in shares)			3,815,304
Sale of common stock, net of issuance costs			$ 426,074		39,091,045			39,517,119
Sale of common stock, net of issuance costs (in shares)			42,607,394
Stock-based compensation expense					1,129,747			1,129,747
Net loss						(13,106,521)		(13,106,521)
Balance at Mar. 31, 2021			$ 1,736,058		$ 336,197,455	$ (317,282,341)		$ 20,651,172
Balance, ending (in shares) at Mar. 31, 2021			173,605,807

Consolidated Statements of Cash Flows - USD ($)	6 Months Ended
Consolidated Statements of Cash Flows - USD ($)	Mar. 31, 2021	Mar. 31, 2020
OPERATING ACTIVITIES
Net loss	$ (27,562,435)	$ (22,303,015)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	163,283	351,623
Loss on extinguishment of debt		8,060,580
Non-cash interest expense	392,028	135,787
Stock-based compensation	2,284,388	664,016
Change in fair value of redemption feature		(1,796,982)
Change in fair value of warrant liability	334,144	(202,142)
Impairment of property and equipment		423,328
Gain on settlement of lease termination obligation	(552,340)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(1,323,108)	229,616
Other assets	137,579	(83,358)
Operating lease liability	(91,721)	(80,572)
Accounts payable	3,685,278	1,028,736
Accrued expenses	(2,537,903)	(233,806)
Other liabilities		49,455
Net cash used in operating activities	(25,070,807)	(13,756,734)
FINANCING ACTIVITIES
Proceeds from the sale of common stock, net of offering costs	39,779,507	9,457,400
Proceeds from debt	10,000,000
Payment of debt issuance costs	(8,032)
Proceeds from exercise of common stock warrants	3,585,809	1,138,900
Payments of finance lease obligations	(16,533)	(178,757)
Repayment of debt	(3,637,076)	(23,414)
Net cash provided by financing activities	49,703,675	10,394,129
Net increase (decrease) in cash	24,632,868	(3,362,605)
Cash at beginning of period	12,535,986	8,015,528
Cash at end of period	37,168,854	4,652,923
Supplemental disclosure of cash flow information
Cash paid for interest	10,490	718,521
Supplemental schedule of non-cash financing activities:
Unsecured notes and accrued interest converted into common stock		1,548,426
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	$ 262,388	$ 260,452

Organization and Description of Business	6 Months Ended
Organization and Description of Business	Mar. 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 clinical and chemistry, manufacturing and control activities are currently active for NORSE TWO, the Company’s remaining clinical trials under its 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 six months ended March 31, 2021 were not significantly impacted by COVID-19.

Liquidity	6 Months Ended
Liquidity	Mar. 31, 2021
Liquidity
Liquidity	2. Liquidity The Company has incurred substantial losses and negative cash flows from operations since its inception. As of March 31, 2021, the Company had $10.5 million of principal and accrued interest due under an unsecured promissory note maturing on January 1, 2022, 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. 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 as of March 31, 2021 will be sufficient to fund its operations through November 2021. 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 Summary of Significant Accounting Policies

6 Months Ended

Mar. 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 (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

In the opinion of management, the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2021 and its results of operations for the three and six months ended March 31, 2021 and 2020, cash flows for the six months ended March 31, 2021 and 2020, and convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended March 31, 2021 and 2020. Operating results for the three and six months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2021. 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, 2020 included in the Company’s Annual Report on Form 10‑K filed with the Securities and Exchange Commission (“SEC”) on December 23, 2020 and amended on January 28, 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.

Net loss per share

Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period.

For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss.

The following table sets forth the computation of basic earnings per share and diluted earnings per share:


		Three months ended March 31,			Six months ended March 31,
	2021		2020		2021		2020
Net loss attributable to common stockholders	$	(13,106,521)	$	(17,459,591)	$	(27,562,435)	$	(35,937,275)
Common stock outstanding (weighted average)		150,730,191		47,895,771		136,080,637		38,849,364
Basic and diluted net loss per share	$	(0.09)	$	(0.36)	$	(0.20)	$	(0.93)

The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of March 31, 2021 and 2020, as they would be antidilutive:


	As of March 31,
	2021	2020
Performance-based stock units	2,470	2,470
Stock options	12,010,781	2,218,551
Common stock warrants	5,129,460	6,463,338

Recently issued and adopted 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 to the Company’s financial statements.

Fair Value Measurements

6 Months Ended

Mar. 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 assets and liabilities that are measured at fair value on a recurring basis:


	March 31, 2021
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	404,916

	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 six months ended March 31, 2021:



	Warrants
Balance at October 1, 2020	$	70,772
Change in fair value		334,144
Balance at March 31, 2021	$	404,916

The warrants issued in connection with the convertible senior secured notes (see Note 8) 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:


	March 31, 2021			September 30, 2020
Risk-free interest rate		0.60	%		0.24	%
Remaining contractual life of warrant		3.9	years		4.4	years
Expected volatility		98.8	%		94.7	%
Annual dividend yield		—	%		—	%
Fair value of common stock	$	2.25	per share	$	0.72	per share

Fair Value of Other Financial Instruments

The fair value and carrying value of the PPP loan included in long-term debt on the consolidated balance sheets on March 31, 2021, was $868,000 and $904,200, respectively. The fair value and carrying value of the unsecured promissory note included in long-term debt on the consolidated balance sheets on March 31, 2021, was $10,546,000 and $10,383,996, respectively. The estimated fair values were based on discounted expected future cash flows using prevailing interest rates that are Level 3 inputs under the fair value hierarchy.

- 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, Net

6 Months Ended

Mar. 31, 2021

Property and Equipment, Net

Property and Equipment, Net

5. Property and Equipment, Net

Property and equipment, net, consists of:


	March 31, 2021		September 30, 2020
Laboratory equipment	$	1,067,351	$	1,067,351
Less: accumulated depreciation and amortization		(821,914)		(740,102)
	$	245,437	$	327,249

Depreciation expense was $40,906 and $63,775 for the three months ended March 31, 2021 and 2020, respectively and $81,812 and $127,551 for the six months ended March 31, 2021 and 2020, respectively.

Other Assets

6 Months Ended

Mar. 31, 2021

Other Assets

Other Assets

6. Other Assets

Other assets consist of:


	March 31, 2021		September 30, 2020
Investment in PRC joint venture	$	900,000	$	900,000
Other assets		173,536		394,448
	$	1,073,536	$	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, Syntone Biopharma Ltd, that will be 80% owned by Syntone PRC 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.

Accrued Expenses

6 Months Ended

Mar. 31, 2021

Accrued Expenses

Accrued Expenses

7. Accrued Expenses

Accrued expenses consists of:


	March 31, 2021		September 30, 2020
Compensation	$	854,263	$	579,618
Severance and related costs		—		9,521
Research and development		3,167,136		2,890,333
Interest payable		8,175		3,691
Professional fees		326,335		132,085
Lease termination obligation		—		3,971,111
Other accrued expenses		141,300		170,951
	$	4,497,209	$	7,757,310

Debt

6 Months Ended

Mar. 31, 2021

Debt

Debt

8. Debt

Debt consists of:


	March 31, 2021		September 30, 2020
Unsecured promissory note	$	10,535,601	$	—
Paycheck Protection Program term loan		904,200		904,200
Equipment loans		25,709		50,285
Total debt		11,465,510		954,485
Less: unamortized loan costs		(151,605)		—
Total debt, net of unamortized loan costs		11,313,905		954,485
Less: current portion		(11,184,734)		(50,285)
Long-term debt	$	129,171	$	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 and matures 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. During the three and six months ended March 31, 2021, the Company recognized $242,819, and $392,028, respectively, 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 is required to pay the lender equal monthly payments of principal and interest as required to fully amortize any principal amount outstanding on the PPP term loan as of October 15, 2021 by May 2, 2022. The Company has the right to prepay any amounts outstanding under this loan at any time and from time to time, in whole or in part, without penalty. Aggregate interest expense on the PPP loan for the three and six months ended March 31, 2021 was $2,205, and $4,484, respectively.

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. 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 three months ended December 31, 2019 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.

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.

During the year ended September 30, 2020, the holder of the new senior secured notes converted the entire outstanding principal and accrued interest and as of September 30, 2020, there were no longer any new senior secured notes outstanding.

Aggregate interest expense on the Old Senior Notes and the new senior secured notes for the three and six months ended March 31, 2020 was $348,541, and $550,062, 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”). Concurrently with the execution of this agreement, the Lender purchased two stockholder notes issued by the Company previously in the original principal amount of $1,000,000 with an aggregate outstanding balance as of March 7, 2019 of $1,947,133, including accrued interest. The stockholder notes were accruing interest at the rate of 2.5% per month. The Lender agreed to refrain and forbear from bringing any action to collect under the stockholder notes until March 7, 2020 and to reduce the interest rates currently in effect to 12.0% per annum simple interest during such forbearance period. The Company also agreed to, at Lender’s election, repay or exchange the stockholder notes (or portions thereof) for shares of the Company's common stock at an exchange rate of $13.44 per share or, beginning September 2019, at 95% of the average of the two lowest closing bid prices in the prior twenty trading days, as applicable.

During the three months ended December 31, 2019, 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 $1.10. As of December 31, 2019, these unsecured notes were no longer outstanding. During the six months ended March 31, 2020, the Company recognized $12,997 of interest expense related to the unsecured notes. No interest expense related to the unsecured notes was recognized during the three months ended March 31, 2020.

Stockholder notes


	March 31, 2021		September 30, 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 in the amount of $800,000 that did not bear interest 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.

Commitments and Contingencies

6 Months Ended

Mar. 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 recorded in accounts payable at March 31, 2021, and 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

In March 2021, the Company assigned its Monmouth Junction, New Jersey corporate office lease to a third party and as of March 31, 2021, did not have remaining future obligations. Upon assignment, the Company 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. The future minimum lease payments for the new lease total $135,535.

On May 6, 2020, the Company terminated its lease agreement for approximately 66,000 square feet of office, manufacturing and laboratory space located in Cranbury, New Jersey, which previously served as its headquarters, and relocated its corporate office to Monmouth Junction, New Jersey, a site previously used as a warehouse location. The Company’s Monmouth Junction, New Jersey lease matures in September 2021. In consideration for the termination of the Cranbury lease, the Company agreed to make payments to the landlord totaling $981,987, payable in eight monthly installments commencing May 1, 2020. In November 2020 the remaining portion of the liability was paid in full. On September 30, 2020, the lease termination obligation was included in accounts payable on the consolidated balance sheet.

A rollforward of the charges incurred to general and administrative expense for the six months ended March 31, 2021 is as follows:


	Balance		Expensed / Accrued		Cash		Non-cash		Balance
	October 1, 2020		Expense		Payments		Adjustments		March 31, 2021
Lease termination payments	$	356,987	$	—	$	(356,987)	$	—	$	—

Equipment leases

The Company has equipment leases, with terms between 12 and 36 months, recorded as finance leases. The equipment leases bear interest between 4.0% and 13.0%.

Certain lease agreements contain provisions for future rent increases. Payments due under the lease contracts include minimum payments that the Company is obligated to make under the non-cancelable initial terms of the leases as the renewal terms are at the Company’s option. Lease expense is recorded as research and development or general and administrative based on the use of the leased asset.

The components of lease cost for the three and six months ended March 31, 2021 and 2020 are as follows:


	Three months ended March 31,				Six months ended March 31,
	2021		2020		2021		2020
Finance lease cost:
Amortization of right-of-use assets	$	—	$	75,000	$	—	$	150,000
Interest on lease liabilities		1,005		361,033		2,787		733,256
Total finance lease cost		1,005		436,033		2,787		883,256
Operating lease cost		43,625		43,625		87,250		87,250
Total lease cost	$	44,630	$	479,658	$	90,037	$	970,506

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


	March 31, 2021		September 30, 2020
Operating leases:
Right-of-use asset	$	—	$	166,986
Operating lease liabilities		—		187,486
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		55,727		72,260
Weighted-average remaining lease term (years):
Operating leases		—		1.0
Finance leases		2.2		2.4
Weighted-average discount rate:
Operating leases		—		9.0%
Finance leases		9.0%		8.5%

Other information related to leases for the six months ended March 31, 2021 are as follows:


	Six months ended March 31,
	2021		2020
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	2,787	$	713,364
Operating cash flows from operating leases		97,500		93,750
Financing cash flows from finance leases		16,533		178,757
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—	$	—
Finance leases		—		—

Future minimum lease payments under non-cancelable leases as of March 31, 2021 are as follows for the years ending September 30:


	Finance leases
2021 (remaining six months)		15,551
2022		29,605
2023		13,149
2024		4,383
Total undiscounted lease payments	$	62,688
Less: Imputed interest		6,961
Total lease obligations	$	55,727

Office and laboratory lease termination obligation

In August 2018, the Company entered into a lease termination agreement effective September 1, 2018, to terminate the lease for unutilized office and laboratory space in Cranbury, New Jersey. In consideration for the termination of the lease, the Company agreed to make payments to the landlord totaling up to $5.8 million, which 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 7th, 8th, 9th and a portion of the 10th 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.

A roll forward of the charges incurred to general and administrative expense for the six months ended March 31, 2021 is as follows:


	Balance		Expensed / Accrued		Cash			Non-cash	Balance
	October 1, 2020		Expense		Payments			Adjustments	March 31, 2021
Lease termination payments	$	3,971,111	$	111,315	$	(3,540,336)	$	(542,090)	$	—

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

6 Months Ended

Mar. 31, 2021

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

10. Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Common stock

In February 2021, the Company issued in an underwritten public offering, including partial exercise of the underwriters’ overallotment option, an aggregate of 38,593,767 shares of common stock at a purchase price per share of $1.00 for $36.0 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 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 $6.7 million in net proceeds after payment of placement agent fees and other offering costs. In a separate concurrent private placement, the Company issued 2,460,630 shares of common stock and warrants to purchase up to an aggregate of 1,230,315 shares of common stock to GMS Ventures, at a combined purchase price per share and accompanying warrant of $1.016 for $2.5 million. The warrants issued were exercisable immediately at an exercise price of $0.9535 per share and will expire four years from the issuance date.

In connection with the registered direct offering and concurrent private placement of warrants to those investors, the Company issued placement agent warrants to purchase up to an aggregate of 531,890 shares of common stock, on substantially the same terms as the concurrent private placement warrants, at an exercise price of $1.27 per share and a 5-year term.

Effective March 19, 2020, following approval of the Company’s stockholders, the Company issued an aggregate of 7,244,739 shares of its common stock to the four former principals (who include two of its named executive officers, Messrs. Dagnon and Evanson) of MTTR, LLC (“MTTR”) pursuant to their respective consulting agreements that were entered into on January 27, 2020 concurrent with the termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Refer to Note 11 for the accounting of the restricted stock issued and Note 12 for further details on the terminated MTTR strategic partnership agreement.

During the six months ended March 31, 2020, the Company issued 109 shares of common stock, respectively, upon the vesting of RSUs.

Series A‑1 convertible preferred stock

A total of 200,000 shares of Series A-1 Convertible Preferred Stock (the “Series A-1”) were authorized for issuance under the Certificate of Designation of Series A-1 Convertible Preferred Stock of the Company (the “Certificate of Designation”). The shares of Series A-1 had a stated value of $100.00 per share, and ranked senior to all junior securities (as defined in the Certificate of Designation).

On March 23, 2020, the Company issued 29,358,621 shares of its common stock upon conversion of all 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. As of March 31, 2021 and September 30, 2020, there were no shares of Series A-1 outstanding.

The Series A-1 accrued dividends at a rate of 10% per annum, compounded quarterly, payable quarterly at the Company’s option in cash or in kind in additional shares of Series A-1. During the six months ended March 31, 2020, the Company issued 1,661 shares of Series A-1 to settle the related dividends that were due on a quarterly basis.

Common stock warrants

As of March 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		416,666	$	12.00
December 22, 2024	(i)	277,128	$	12.00
April 13, 2025	(i)	145,686	$	12.00
May 31, 2025	(i)	62,437	$	12.00
February 24, 2025		172,864	$	1.27
February 26, 2024		1,747,047	$	0.9535
June 22, 2025		191,268	$	1.5188
January 28, 2026		2,116,364	$	1.2500
		5,129,460

(i)

The warrants were issued in connection with the convertible senior secured notes (see Note 8) 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 outstanding 15-month warrants and five-year warrants issued April 12, 2019 (the “April 2019 Warrants”), which originally had an exercise price of $2.90 per share of the Company’s common stock. The exercise price of all outstanding April 2019 Warrants was reduced to $0.2320 per share and the exercise period was amended such that all April 2019 Warrants expire on December 24, 2019. Immediately prior to expiration, all then unexercised April 2019 Warrants were automatically net exercised pursuant to the amended provisions.

The estimated change in fair value of warrants amended during the three and six months ended March 31, 2020 was $1,431,406 and $3,140,009, respectively, 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 six months ended March 31, 2021, warrants to purchase an aggregate of 3,641,507 shares of common stock with a weighted averaged exercise price of $0.9847 were exercised for aggregate gross proceeds to the Company of $3,585,809. 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.

During the six months ended March 31, 2020, warrants to purchase an aggregate of 15,085,240 shares of common stock with a weighted averaged exercise price of $0.232 were exercised for an aggregate 13,003,414 shares of the Company's common stock; and warrants to purchase an aggregate of 80,797 shares of common stock with a weighted averaged exercise price of $0.08 expired. In aggregate, 10,157,050 of the exercised warrants were April 2019 Warrants, described above, exercised pursuant to the net exercise provisions therein, as amended.

Stock-Based Compensation

6 Months Ended

Mar. 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 March 31, 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 March 31, 2021, 15,657,586 shares remained available for grant under the 2015 Plan.

Stock options and RSUs are granted under the Company’s 2015 Plan and generally vest over a period of one to four years from the date of grant and, in the case of stock options, have a term of 10 years. The Company recognizes the grant date fair value of each option and share of RSU over its vesting period.

The Company recorded stock-based compensation expense in the following expense categories of its statements of operations for the three and six months ended March 31, 2021 and 2020:


	Three months ended March 31,				Six months ended March 31,
	2021		2020		2021		2020
Research and development	$	228,240	$	41,148	$	468,211	$	148,938
General and administrative		901,507		263,391		1,816,177		515,078
	$	1,129,747	$	304,539	$	2,284,388	$	664,016

Stock options

As of March 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, 2020	3,762,143	$	2.01
Granted	8,361,645		0.74
Forfeited or expired	(113,007)		0.73
Balance at March 31, 2021	12,010,781		1.14	9.3	$	15,228,082
Vested and exercisable	1,726,016		1.93	8.8	$	1,739,158
Vested and expected to vest at March 31, 2021	12,010,781	$	1.14	9.3

The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options.

The weighted average grant date fair value of the options awarded to employees for the six months ended March 31, 2021 and 2020 was $0.56 and $0.72 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:


	Six months ended March 31,
	2021		2020
Risk-free interest rate	0.39	%	1.13	%
Expected life (years)	6.01		5.71
Expected volatility	95.4	%	89.2	%
Expected dividend yield	—		—

As of March 31, 2021, there was $5,851,014 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 2.58 years.

Performance-based stock units

The Company has issued PSUs, which generally have a ten-year life from the date of grant. Upon exercise, the PSU holder receives common stock or cash at the Company’s discretion.

The following table summarizes the activity related to PSUs during the three months ended March 31, 2021:


				Weighted
				Average
	Number	Base		Remaining
	of	Price		Contractual
	PSUs	Per PSU		Term (Years)
Balance at October 1, 2020	2,470	$	49.97
Forfeitures	—		—
Balance at March 31, 2021	2,470		49.97	3.8
Vested and exercisable at March 31, 2021	2,470		49.97	3.8
Vested and expected to vest at March 31, 2021	2,470	$	49.97	3.8

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 2 clinical trial of ONS-5010 by certain dates. The repurchase right may also lapse as to 50% or 100% of the shares if the Company enters into certain agreements pertaining to ONS-5010 that meet certain value thresholds or the Company’s share price meets certain predefined targets. The repurchase right also lapses as to 100% of the shares upon the earliest to occur of (i) filing of the 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 March 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 and six months ended March 31, 2021, the Company recognized compensation expense related to the restricted stock of $151,764 and $303,529, respectively. During the three and six months ended March 31, 2020, the Company recognized compensation expense related to the restricted stock of $78,984. As of March 31, 2021, there was $2,307,477 of unrecognized compensation expense related to the restricted stock.

Related-Party Transactions	6 Months Ended
Related-Party Transactions	Mar. 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. Mr. Dagnon and Mr. Evanson have also agreed to provide consulting services to an affiliate of BioLexis pursuant to a separate arrangement. On January 27, 2020, the Company entered into a termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Pursuant to the agreement, the Company agreed (x) to issue to the four principals of MTTR (who include two of its named executive officers, Messrs. Dagnon and Evanson), an aggregate of 7,244,739 shares of its common stock, subject to stockholder approval, (y) to enter into consulting agreements with each of the four principals setting forth the terms of his respective compensation arrangement, and (z) to pay MTTR a one-time settlement fee of $110,000, upon effectiveness of the agreement. Concurrently, the Company also entered into consulting agreements directly with each of the four principals of MTTR setting forth the terms of his respective compensation arrangement, as well as providing for certain transfer restrictions and repurchase rights applicable to the shares of common stock to be issued pursuant hereto. The termination agreement, and the consulting agreements, became effective upon stockholder approval of the share issuance on March 19, 2020. Refer to Note 11 for the accounting of the restricted stock issued and compensation expense recognized. During the three months ended March 2021 and 2020, MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate $73,572 and $169,347, respectively; and $541,225 and $780,911 during the six months ended March 31, 2021 and 2020, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 11). As of March 31, 2021, and September 30, 2020 an aggregate $90,476 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.

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

6 Months Ended

Mar. 31, 2021

Basis of Presentation and Summary of Significant Accounting Policies

Basis of presentation

Use of estimates

Net loss per share

The following table sets forth the computation of basic earnings per share and diluted earnings per share:


		Three months ended March 31,			Six months ended March 31,
	2021		2020		2021		2020
Net loss attributable to common stockholders	$	(13,106,521)	$	(17,459,591)	$	(27,562,435)	$	(35,937,275)
Common stock outstanding (weighted average)		150,730,191		47,895,771		136,080,637		38,849,364
Basic and diluted net loss per share	$	(0.09)	$	(0.36)	$	(0.20)	$	(0.93)


	As of March 31,
	2021	2020
Performance-based stock units	2,470	2,470
Stock options	12,010,781	2,218,551
Common stock warrants	5,129,460	6,463,338

Recently issued accounting pronouncements

Recently issued and adopted accounting pronouncements

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

6 Months Ended

Mar. 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 March 31,			Six months ended March 31,
	2021		2020		2021		2020
Net loss attributable to common stockholders	$	(13,106,521)	$	(17,459,591)	$	(27,562,435)	$	(35,937,275)
Common stock outstanding (weighted average)		150,730,191		47,895,771		136,080,637		38,849,364
Basic and diluted net loss per share	$	(0.09)	$	(0.36)	$	(0.20)	$	(0.93)

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


	As of March 31,
	2021	2020
Performance-based stock units	2,470	2,470
Stock options	12,010,781	2,218,551
Common stock warrants	5,129,460	6,463,338

Fair Value Measurements (Tables)

6 Months Ended

Mar. 31, 2021

Fair Value Measurements

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


	March 31, 2021
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	404,916

	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



	Warrants
Balance at October 1, 2020	$	70,772
Change in fair value		334,144
Balance at March 31, 2021	$	404,916

Schedule of fair value of the warrant liability


	March 31, 2021			September 30, 2020
Risk-free interest rate		0.60	%		0.24	%
Remaining contractual life of warrant		3.9	years		4.4	years
Expected volatility		98.8	%		94.7	%
Annual dividend yield		—	%		—	%
Fair value of common stock	$	2.25	per share	$	0.72	per share

Property and Equipment, Net (Tables)

6 Months Ended

Mar. 31, 2021

Property and Equipment, Net

Schedule of property and equipment


	March 31, 2021		September 30, 2020
Laboratory equipment	$	1,067,351	$	1,067,351
Less: accumulated depreciation and amortization		(821,914)		(740,102)
	$	245,437	$	327,249

Other Assets (Tables)

6 Months Ended

Mar. 31, 2021

Other Assets

Schedule of other assets


	March 31, 2021		September 30, 2020
Investment in PRC joint venture	$	900,000	$	900,000
Other assets		173,536		394,448
	$	1,073,536	$	1,294,448

Accrued Expenses (Tables)

6 Months Ended

Mar. 31, 2021

Accrued Expenses

Schedule of accrued expenses


	March 31, 2021		September 30, 2020
Compensation	$	854,263	$	579,618
Severance and related costs		—		9,521
Research and development		3,167,136		2,890,333
Interest payable		8,175		3,691
Professional fees		326,335		132,085
Lease termination obligation		—		3,971,111
Other accrued expenses		141,300		170,951
	$	4,497,209	$	7,757,310

Debt (Tables)

6 Months Ended

Mar. 31, 2021

Debt

Schedule of debt


	March 31, 2021		September 30, 2020
Unsecured promissory note	$	10,535,601	$	—
Paycheck Protection Program term loan		904,200		904,200
Equipment loans		25,709		50,285
Total debt		11,465,510		954,485
Less: unamortized loan costs		(151,605)		—
Total debt, net of unamortized loan costs		11,313,905		954,485
Less: current portion		(11,184,734)		(50,285)
Long-term debt	$	129,171	$	904,200

Schedule of stockholder notes


	March 31, 2021		September 30, 2020
Restricted stock repurchase notes	$	—	$	800,000
Common stock repurchase note		—		2,812,500
		—		3,612,500
Less: current portion		—		(3,612,500)
	$	—	$	—

- 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)

6 Months Ended

Mar. 31, 2021

Long-term Purchase Commitment [Line Items]

Schedule of lease information

The components of lease cost for the three and six months ended March 31, 2021 and 2020 are as follows:


	Three months ended March 31,				Six months ended March 31,
	2021		2020		2021		2020
Finance lease cost:
Amortization of right-of-use assets	$	—	$	75,000	$	—	$	150,000
Interest on lease liabilities		1,005		361,033		2,787		733,256
Total finance lease cost		1,005		436,033		2,787		883,256
Operating lease cost		43,625		43,625		87,250		87,250
Total lease cost	$	44,630	$	479,658	$	90,037	$	970,506

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


	March 31, 2021		September 30, 2020
Operating leases:
Right-of-use asset	$	—	$	166,986
Operating lease liabilities		—		187,486
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		55,727		72,260
Weighted-average remaining lease term (years):
Operating leases		—		1.0
Finance leases		2.2		2.4
Weighted-average discount rate:
Operating leases		—		9.0%
Finance leases		9.0%		8.5%

Other information related to leases for the six months ended March 31, 2021 are as follows:


	Six months ended March 31,
	2021		2020
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	2,787	$	713,364
Operating cash flows from operating leases		97,500		93,750
Financing cash flows from finance leases		16,533		178,757
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—	$	—
Finance leases		—		—

Schedule of finance lease future minimum payments


	Finance leases
2021 (remaining six months)		15,551
2022		29,605
2023		13,149
2024		4,383
Total undiscounted lease payments	$	62,688
Less: Imputed interest		6,961
Total lease obligations	$	55,727

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		March 31, 2021
Lease termination payments	$	356,987	$	—	$	(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	March 31, 2021
Lease termination payments	$	3,971,111	$	111,315	$	(3,540,336)	$	(542,090)	$	—

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) (Tables)

6 Months Ended

Mar. 31, 2021

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Schedule of warrants outstanding


		Shares of
		common stock
		issuable upon
		exercise of	Exercise Price
Expiration Date		warrants	Per Share
February 18, 2022		416,666	$	12.00
December 22, 2024	(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	$	1.5188
January 28, 2026		2,116,364	$	1.2500
		5,129,460

(i)

Stock-Based Compensation (Tables)

6 Months Ended

Mar. 31, 2021

Stock-Based Compensation

Schedule of stock-based compensation expense


	Three months ended March 31,				Six months ended March 31,
	2021		2020		2021		2020
Research and development	$	228,240	$	41,148	$	468,211	$	148,938
General and administrative		901,507		263,391		1,816,177		515,078
	$	1,129,747	$	304,539	$	2,284,388	$	664,016

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	3,762,143	$	2.01
Granted	8,361,645		0.74
Forfeited or expired	(113,007)		0.73
Balance at March 31, 2021	12,010,781		1.14	9.3	$	15,228,082
Vested and exercisable	1,726,016		1.93	8.8	$	1,739,158
Vested and expected to vest at March 31, 2021	12,010,781	$	1.14	9.3

Schedule of option assumptions


	Six months ended March 31,
	2021		2020
Risk-free interest rate	0.39	%	1.13	%
Expected life (years)	6.01		5.71
Expected volatility	95.4	%	89.2	%
Expected dividend yield	—		—

Schedule of performance-based stock units activity


				Weighted
				Average
	Number	Base		Remaining
	of	Price		Contractual
	PSUs	Per PSU		Term (Years)
Balance at October 1, 2020	2,470	$	49.97
Forfeitures	—		—
Balance at March 31, 2021	2,470		49.97	3.8
Vested and exercisable at March 31, 2021	2,470		49.97	3.8
Vested and expected to vest at March 31, 2021	2,470	$	49.97	3.8

Liquidity (Details) - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Liquidity
Debt carrying amount	$ 11,465,510	$ 954,485
Paycheck Protection Program
Liquidity
Debt carrying amount	900,000
Unsecured promissory note
Liquidity
Debt carrying amount	$ 10,535,601

Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Basic and diluted earnings per share:
Net loss attributable to common stockholders	$ (13,106,521)	$ (17,459,591)	$ (27,562,435)	$ (35,937,275)
Common stock outstanding (weighted average)	150,730,191	47,895,771	136,080,637	38,849,364
Basic and diluted net loss per share (in dollars per share)	$ (0.09)	$ (0.36)	$ (0.20)	$ (0.93)

- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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+ Details

Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - shares	6 Months Ended
	Mar. 31, 2021	Mar. 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
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	12,010,781	2,218,551
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	5,129,460	6,463,338

Fair Value Measurements (Details) - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Liabilities
Warrant liability	$ 404,916	$ 70,772
Fair value measurements recurring basis \| Level 3
Liabilities
Warrant liability	$ 404,916	$ 70,772

Fair Value Measurements - Changes in fair value (Details) - Common stock warrants	6 Months Ended
	Mar. 31, 2021 USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance, beginning	$ 70,772
Change in fair value	334,144
Balance, ending	$ 404,916

Fair Value Measurements - Assumptions (Details)	Mar. 31, 2021 $ / shares USD ($)	Sep. 30, 2020 $ / shares USD ($)
Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	0.60	0.24
Remaining contractual life of warrant
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs \| $	3.9	4.4
Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	98.8	94.7
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	2.25	0.72

Fair Value Measurements - Additional Information (Details) - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Carrying value	$ 11,313,905	$ 954,485
Paycheck Protection Program
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value	868,000
Carrying value	904,200
Unsecured promissory note
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value	10,546,000
Carrying value	$ 10,383,996

Property and Equipment, Net (Details) - USD ($)	3 Months Ended		6 Months Ended
Property and Equipment, Net (Details) - USD ($)	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020	Sep. 30, 2020
Property and Equipment, Net
Property and equipment, gross	$ 1,067,351		$ 1,067,351		$ 1,067,351
Less: accumulated depreciation and amortization	(821,914)		(821,914)		(740,102)
Property and equipment, net	245,437		245,437		$ 327,249
Depreciation expense	$ 40,906	$ 63,775	$ 81,812	$ 127,551

Other Assets (Details) - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Other Assets
Investment in PRC joint venture	$ 900,000	$ 900,000
Other assets	173,536	394,448
Total other assets	$ 1,073,536	$ 1,294,448

Other Assets - Additional information (Details) - P R C Joint Venture - USD ($)		1 Months Ended
	May 22, 2020	Jun. 30, 2020
Schedule of Equity Method Investments [Line Items]
Ownership percentage	20.00%
Payments to Acquire Interest 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) - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Accrued Expenses
Compensation	$ 854,263	$ 579,618
Severance and related costs		9,521
Research and development	3,167,136	2,890,333
Interest payable	8,175	3,691
Professional fees	326,335	132,085
Lease termination obligation		3,971,111
Other accrued expenses	141,300	170,951
Accrued expenses, total	$ 4,497,209	$ 7,757,310

Debt - Indebtedness Summary (Details) - USD ($)	Mar. 31, 2021	Nov. 05, 2020	Sep. 30, 2020
Debt Instrument [Line Items]
Debt carrying amount	$ 11,465,510		$ 954,485
Less: unamortized loan costs	(151,605)
Total debt	11,313,905		954,485
Less: current portion	(11,184,734)		(50,285)
Long-term debt	129,171		904,200
Unsecured promissory note
Debt Instrument [Line Items]
Debt carrying amount	10,535,601
Less: unamortized loan costs		$ (228,032)
Total debt	10,383,996
Paycheck Protection Program
Debt Instrument [Line Items]
Debt carrying amount	904,200		904,200
Total debt	904,200
Equipment loan
Debt Instrument [Line Items]
Debt carrying amount	$ 25,709		$ 50,285

Debt - Indebtedness - Information (Details) - USD ($)			3 Months Ended	6 Months Ended
Debt - Indebtedness - Information (Details) - USD ($)	Nov. 05, 2020	May 04, 2020	Mar. 31, 2021	Mar. 31, 2021
Debt Instrument [Line Items]
Proceeds from loan				$ 10,000,000
Unamortized discount			$ 151,605	151,605
Unsecured promissory note
Debt Instrument [Line Items]
Proceeds from loan	$ 10,000,000
Original principal amount	10,200,000
Unamortized discount	$ 228,032
Debt Instrument, term	14 months
Interest rate (as a percent)	7.50%
Redemption price (as a percent)	105.00%
Interest expense			242,819	392,028
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			$ 2,205	$ 4,484

Debt - Senior Secured (Details)	1 Months Ended	3 Months Ended	6 Months Ended
Debt - Senior Secured (Details)	Dec. 31, 2019 USD ($) D item	Mar. 31, 2020 USD ($)	Mar. 31, 2021 USD ($) $ / shares	Mar. 31, 2020 USD ($)	Sep. 30, 2020 USD ($)
Debt Instrument [Line Items]
Loss on extinguishment of debt				$ (8,060,580)
Debt outstanding			$ 11,313,905		$ 954,485
Senior Notes
Debt Instrument [Line Items]
Interest expense		$ 348,541		$ 550,062
Old Senior notes
Debt Instrument [Line Items]
Carrying value of notes exchanged	$ 7,254,077
Interest rate (as a percent)	12.00%
Extension fee (as a percent)	3.00%
New Senior secured notes
Debt Instrument [Line Items]
Amount of debt as converted	$ 7,589,027
Bank exchange fee	$ 334,950
Stock price threshold (as a percent)	90.00%
Number of lowest closing bid prices \| item	2
Trading day threshold \| D	20
Floor price \| $ / shares			$ 0.232
Redemption feature	$ 8,264,451
Loss on extinguishment of debt	$ (8,060,580)
Debt outstanding					$ 0
New Senior secured notes \| Expected volatility
Debt Instrument [Line Items]
Redemption feature input	130

Debt - Unsecured Notes (Details)		3 Months Ended		6 Months Ended
Debt - Unsecured Notes (Details)	Mar. 07, 2019 USD ($) D item $ / shares	Mar. 31, 2020 USD ($)	Dec. 31, 2019 USD ($) $ / shares shares	Mar. 31, 2020 USD ($)	Mar. 31, 2021 USD ($)	Sep. 30, 2020 USD ($)
Debt Instrument [Line Items]
Debt outstanding					$ 11,313,905	$ 954,485
Unsecured notes
Debt Instrument [Line Items]
Original principal amount	$ 1,000,000
Debt outstanding	$ 1,947,133
Monthly stated interest rate	2.50%
Interest rate (as a percent)	12.00%
Conversion rate per share \| $ / shares	$ 13.44
Stock price threshold (as a percent)	95.00%
Number of lowest closing bid prices \| item	2
Trading day threshold \| D	20
Carrying value of notes exchanged			$ 977,966
Accrued interest of notes exchanged			$ 570,460
Common stock issued up on conversion of stockholder notes (in shares) \| shares			1,475,258
Interest expense		$ 0		$ 12,997
Unsecured notes \| Weighted average
Debt Instrument [Line Items]
Conversion rate per share \| $ / shares			$ 1.10

Debt - Stockholder Notes (Details) - USD ($)	1 Months Ended	6 Months Ended
Debt - Stockholder Notes (Details) - USD ($)	Nov. 30, 2020	Mar. 31, 2021	Mar. 31, 2020	Sep. 30, 2020
Debt Instrument [Line Items]
Stockholder notes				$ 3,612,500
Less: current portion				(3,612,500)
Repayment of debt		$ 3,637,076	$ 23,414
Restricted stock purchase notes
Debt Instrument [Line Items]
Stockholder notes				800,000
Repayment of debt	$ 800,000
Common stock repurchase note
Debt Instrument [Line Items]
Stockholder notes				$ 2,812,500
Repayment of debt	$ 2,812,500

Commitments and Contingencies (Details) - USD ($)		1 Months Ended	6 Months Ended
Commitments and Contingencies (Details) - USD ($)	Mar. 30, 2021	Apr. 30, 2021	Mar. 31, 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
Accounts Payable
Other Commitments [Line Items]
Settlement payable			$ 625,000

Commitments and Contingencies - Lease termination (Details)		1 Months Ended			6 Months Ended
	May 06, 2020 USD ($) ft²	Mar. 31, 2021 USD ($)	Nov. 30, 2020 USD ($)	Aug. 31, 2018 USD ($)	Mar. 31, 2021 USD ($)	Sep. 30, 2020 USD ($)
Commitment
Gain recognized					$ 552,340
Finance leases, Lease obligation		$ 55,727			$ 55,727	$ 72,260
Lease termination obligation						3,971,111
Corporate Office Lease, Monmouth Junction, New Jersey
Commitment
Gain recognized		$ 10,250
Corporate Office Lease, Iselin, New Jersey
Commitment
Lease term		3 years			3 years
Finance leases, Lease obligation		$ 135,535			$ 135,535
Cranbury NJ, May 2020 lease termination
Commitment
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 recognized					$ 542,090
Lease termination obligation				$ 5,800,000		$ 3,971,111
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
Termination Of Lease			$ 3,250,000
Security deposit			$ 190,336	$ 174,250

Commitments and Contingencies - Lease termination rollforward (Details)	6 Months Ended
	Mar. 31, 2021 USD ($)
Leases
Balance, beginning	$ 3,971,111
Cranbury NJ, May 2020 lease termination
Leases
Balance, beginning	356,987
Cash payments	(356,987)
Cranbury NJ, August 2018 lease termination
Leases
Balance, beginning	3,971,111
Expensed accrued expense	111,315
Cash payments	(3,540,336)
Non-cash Adjustments	$ (542,090)

Commitments and Contingencies - Lease cost (Details) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Lease cost
Amortization of right-of-use assets		$ 75,000		$ 150,000
Interest on lease liabilities	$ 1,005	361,033	$ 2,787	733,256
Total finance lease cost	1,005	436,033	2,787	883,256
Operating lease cost	43,625	43,625	87,250	87,250
Total lease cost	$ 44,630	$ 479,658	$ 90,037	$ 970,506
Minimum
Leases
Finance lease term	12 months		12 months
Finance lease interest (as a percent)	4.00%		4.00%
Maximum
Leases
Finance lease term	36 months		36 months
Finance lease interest (as a percent)	13.00%		13.00%

Commitments and Contingencies - Lease balance sheet (Details) - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Leases
Operating leases, Right-of-use asset		$ 166,986
Operating leases, Lease obligation		187,486
Finance leases, Lease obligation	$ 55,727	$ 72,260
Operating leases, Weighted-average remaining lease term		1 year
Finance leases, Weighted-average remaining lease term	2 years 2 months 12 days	2 years 4 months 24 days
Operating leases, Weighted-average discount rate (as a percent)		9.00%
Finance leases, Weighted-average discount rate (as a percent)	9.00%	8.50%

Commitments and Contingencies - Lease cashflow (Details) - USD ($)	6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Leases
Operating cash flows from finance leases	$ 2,787	$ 713,364
Operating cash flows from operating leases	97,500	93,750
Financing cash flows from finance leases	$ 16,533	$ 178,757

Commitments and Contingencies - Lease minimum payments (Details) - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Finance leases
2021 (remaining six months)	$ 15,551
2022	29,605
2023	13,149
2024	4,383
Total undiscounted lease payments	62,688
Less: Imputed interest	6,961
Total lease obligations	$ 55,727	$ 72,260

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) - Common Stock (Details) - USD ($)				1 Months Ended		3 Months Ended	6 Months Ended
	Mar. 23, 2020	Mar. 19, 2020	Sep. 11, 2017	Feb. 28, 2021	Feb. 29, 2020	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020	Mar. 24, 2021	Mar. 23, 2021	Sep. 30, 2020	Mar. 22, 2020	Dec. 23, 2019	Apr. 12, 2019
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Issuance of vested restricted stock units (in shares)								109
Number of share issued		7,244,739
Shares of common stock issuable upon exercise of warrants							5,129,460
Proceeds from issuance of stock							$ 39,779,507	$ 9,457,400
Number of shares issued upon vesting of restricted stock units (in shares)								109
Common stock, shares authorized							325,000,000		325,000,000	200,000,000	325,000,000
Deemed Dividend, Amendment Of Series A1 Convertible Preferred Stock						$ 10,328,118		$ 10,328,118
Direct registered offering
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued					7,598,426
Shares of common stock issuable upon exercise of warrants					3,799,213
Shares issued, price per share					$ 1.016
Proceeds from issuance of stock					$ 6,700,000
Private Placement
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued				3,000,000	2,460,630
Shares of common stock issuable upon exercise of warrants					1,230,315
Shares issued, price per share				$ 1.00	$ 1.016
Proceeds from issuance of stock				$ 3,000,000
Net proceeds from warrants					$ 2,500,000
Exercise price per share					$ 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
Shares issued, price per share					$ 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				$ 1.00
Proceeds from issuance of stock				$ 36,000,000
Exercise price per share				$ 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			$ 1.00
Proceeds from issuance of stock			$ 1,000,000
Common stock warrants
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued								13,003,414
Shares of common stock issuable upon exercise of warrants						15,085,240	3,641,507	15,085,240
Proceeds from issuance of stock							$ 3,585,809
Exercise price per share	$ 0.232					$ 0.232	$ 0.9847	$ 0.232					$ 0.2320	$ 2.90
Series A-1 convertible preferred stock
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Number of share issued	29,358,621
Convertible preferred stock, shares authorized							200,000				200,000
Shares issued, price per share							$ 100.00
Number of stock converted	68,112
Conversion rate per share	$ 431.03447263											$ 18.89797
Deemed Dividend, Amendment Of Series A1 Convertible Preferred Stock							$ 10,328,118
Convertible preferred stock outstanding							0				0
Accrued dividends rate							10.00%
Preferred stock issued to settle dividends (in shares)								1,661

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) - Warrants summary (Details)	Mar. 31, 2021 $ / shares shares
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	5,129,460
February 18, 2022
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	416,666
Exercise price per share \| $ / shares	$ 12.00
December 22, 2024
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	277,128
Exercise price per share \| $ / shares	$ 12.00
April 13, 2025
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	145,686
Exercise price per share \| $ / shares	$ 12.00
May 31, 2025
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	62,437
Exercise price per share \| $ / shares	$ 12.00
February 24, 2025
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	172,864
Exercise price per share \| $ / shares	$ 1.27
February 26, 2024
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	1,747,047
Exercise price per share \| $ / shares	$ 0.9535
June 22, 2025
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	191,268
Exercise price per share \| $ / shares	$ 1.5188
January 28, 2026
Class of Warrant or Right [Line Items]
Shares of common stock issuable upon exercise of warrants	2,116,364
Exercise price per share \| $ / shares	$ 1.25

Common Stock, Convertible Preferred Stock and Stockholders’ Equity (Deficit) - Warrants (Details) - USD ($)		3 Months Ended	6 Months Ended
	Mar. 19, 2020	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020	Mar. 23, 2020	Dec. 23, 2019	Apr. 12, 2019
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Deemed dividend upon modification of warrants		$ 1,431,406		$ 3,140,009
Shares of common stock issuable upon exercise of warrants			5,129,460
Proceeds from issuance of stock			$ 39,779,507	$ 9,457,400
Number of share issued	7,244,739
Common stock warrants
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Exercise price per share		$ 0.232	$ 0.9847	$ 0.232	$ 0.232	$ 0.2320	$ 2.90
Shares of common stock issuable upon exercise of warrants		15,085,240	3,641,507	15,085,240
Proceeds from issuance of stock			$ 3,585,809
Warrants to purchase of common stock (in shares)			397,251
Warrants to purchase of common stock exercise price (in dollars per share)			$ 1.51875
Number of share issued				13,003,414
Warrant expired (in shares)		80,797		80,797
Warrants expired (in dollars per share)		$ 0.08		$ 0.08
Warrant, 15 Months
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Warrants exercise term						15 months
Shares of common stock issuable upon exercise of warrants		10,157,050		10,157,050
Warrant, 5 Years
Convertible Preferred Stock And Stockholders' Equity (Deficit) [Line Items]
Warrants exercise term						5 years

Stock-Based Compensation - Information (Details) - $ / shares	6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average grant date fair value of the options awarded to employees	$ 0.56	$ 0.72
Performance-based stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years
2011 Equity Incentive Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares of common stock reserved for issuance	106,490
2011 Equity Incentive Plan \| Performance-based stock units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Awards outstanding	2,470
2015 Equity Incentive Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Aggregate number of common stock authorized for issuance	27,838,019
Number of shares available for grant	15,657,586
Term of award	10 years
2015 Equity Incentive Plan \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	1 year
2015 Equity Incentive Plan \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting period	4 years

Stock-Based Compensation - Expense (Details) - USD ($)	3 Months Ended		6 Months Ended
Stock-Based Compensation - Expense (Details) - USD ($)	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,129,747	$ 304,539	$ 2,284,388	$ 664,016
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	228,240	41,148	468,211	148,938
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 901,507	$ 263,391	$ 1,816,177	$ 515,078

Stock-Based Compensation - Stock option activity (Details)	6 Months Ended
	Mar. 31, 2021 USD ($) $ / shares shares
Number of Shares
Balance, Beginning \| shares	3,762,143
Granted \| shares	8,361,645
Forfeited or expired \| shares	(113,007)
Balance, Ending \| shares	12,010,781
Vested and exercisable \| shares	1,726,016
Vested and expected to vest \| shares	12,010,781
Weighted Average Exercise Price
Balance, Beginning \| $ / shares	$ 2.01
Granted \| $ / shares	0.74
Forfeited or expired \| $ / shares	0.73
Balance, Ending \| $ / shares	1.14
Vested and exercisable \| $ / shares	1.93
Vested and expected to vest \| $ / shares	$ 1.14
Other option information
Balance	9 years 3 months 18 days
Vested and exercisable	8 years 9 months 18 days
Vested and expected to vest	9 years 3 months 18 days
Aggregate intrinsic value \| $	$ 15,228,082
Aggregate intrinsic value, Vest and exercisable \| $	$ 1,739,158

Stock-Based Compensation - Option Assumptions (Details) - Stock options - USD ($)	6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate	0.39%	1.13%
Expected life (years)	6 years 4 days	5 years 8 months 16 days
Expected volatility	95.40%	89.20%
Expected dividend yield	0.00%	0.00%
Unrecognized compensation expense	$ 5,851,014
Weighted average exercise period of unrecognized compensation	2 years 6 months 29 days

Stock-Based Compensation - Performance-Based (Details) - Performance-based stock units	6 Months Ended
	Mar. 31, 2021 $ / shares shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
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
Vested and exercisable \| $ / shares	49.97
Balance, Ending \| $ / shares	49.97
Vested and expected to vest \| $ / shares	$ 49.97
Weighted average remaining contractual term, Outstanding	3 years 9 months 18 days
Weighted average remaining contractual term, Vested and exercisable	3 years 9 months 18 days
Weighted average remaining contractual term, Vested and expected to vest	3 years 9 months 18 days

Stock-Based Compensation - Restricted stock (Details) - USD ($)			3 Months Ended		6 Months Ended
	Mar. 19, 2020	Jan. 27, 2020	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of vested restricted stock units (in shares)						109
Number of share issued	7,244,739
Stock-based compensation expense			$ 1,129,747	$ 304,539	$ 2,284,388	$ 664,016
MTTR, LLC (“MTTR”)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of share issued		7,244,739
Restricted Stock \| MTTR, LLC (“MTTR”)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of share issued		7,244,739
Term following the FDA approval		6 months
Share repurchase price		$ 0.01
Number of shares vested in period					1,811,184
Grant date fair value of share		$ 0.54
Explicit service period		4 years 9 months 18 days
Stock-based compensation expense			151,764	$ 78,984	$ 303,529	$ 78,984
Unamortized expense to be recognized of stock awards other than options			$ 2,307,477		$ 2,307,477
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 (Details) - USD ($)			3 Months Ended		6 Months Ended
Related-Party Transactions (Details) - USD ($)	Mar. 19, 2020	Jan. 27, 2020	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020	Sep. 30, 2020
Related Party Transaction [Line Items]
Shares issued during period	7,244,739
MTTR, LLC (“MTTR”)
Related Party Transaction [Line Items]
Shares issued during period		7,244,739
Contract termination settlement fee		$ 110,000
Related party expense			$ 73,572	$ 169,347	$ 541,225	$ 780,911
Due to related party, current			$ 90,476		$ 90,476		$ 89,762