0001558370-23-001286 | 10-Q | XBRL Viewer

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Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Basic and diluted earnings per share:
Net loss attributable to common stockholders	$ (18,662,513)	$ (14,462,729)
Basic Earnings Per Share
Weighted average shares outstanding, basic (in shares)	227,410,533	188,157,921
Net loss per share of common stock, basic (in dollars per share)	$ (0.08)	$ (0.08)
Diluted Earnings Per Share
Weighted average shares outstanding, diluted (in shares)	227,410,533	188,157,921
Net loss per share of common stock, diluted (in dollars per share)	$ (0.08)	$ (0.08)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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- 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	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Performance-based stock units
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	2,470	2,470
Performance-based stock options
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	1,900,000	1,900,000
Stock options
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	20,726,330	17,904,189
Common stock warrants
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	7,328,549	7,228,829
Convertible debt
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	15,910,000
Conversion rate per share	$ 2.00

Commitments and Contingencies.

3 Months Ended

Dec. 31, 2022

Commitments and Contingencies.

Commitments and Contingencies

8. Commitments and Contingencies

Leases

Corporate office

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

Equipment leases

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

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

The components of lease cost for the three months ended December 31, 2022 and 2021 are as follows:


	Three months ended December 31,
	2022		2021
Lease cost:
Amortization of right-of-use assets	$	—	$	—
Interest on lease liabilities		491		975
Total finance lease cost		491		975
Operating lease cost		11,217		11,217
Total lease cost	$	11,708	$	12,192

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


	December 31, 2022		September 30, 2022
Operating leases:
Right-of-use asset	$	59,582	$	70,360
Operating lease liabilities		15,573		26,995
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		13,221		16,018
Weighted-average remaining lease term (years):
Operating leases		1.3		1.6
Finance leases		1.0		1.3
Weighted-average discount rate:
Operating leases		7.5%		7.5%
Finance leases		13.0%		13.0%

Other information related to leases for the three months ended December 31, 2022 and 2021 are as follows:


	Three months ended December 31,
	2022		2021
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	491	$	975
Operating cash flows from operating leases		11,861		11,522
Financing cash flows from finance leases		2,797		6,801
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—	$	—

Future minimum lease payments under non-cancelable leases as of December 31, 2022 are as follows for the years ending September 30:


	Operating leases		Finance leases
2023 (remaining nine months)	$	15,814	$	9,862
2024		—		4,383
Total undiscounted lease payments		15,814		14,245
Less: Imputed interest		241		1,024
Total lease obligations	$	15,573	$	13,221

Accrued Expenses

3 Months Ended

Dec. 31, 2022

Accrued Expenses

Accrued Expenses

6. Accrued Expenses

Accrued expenses consists of:



	December 31, 2022		September 30, 2022
Compensation	$	2,503,382	$	1,976,252
Research and development		5,121,215		744,154
Professional fees		1,345,561		564,423
Commercial consulting		40,338		—
Other accrued expenses		17,143		143,071
	$	9,027,639	$	3,427,900

Common Stock and Stockholders' Equity

3 Months Ended

Dec. 31, 2022

Common Stock and Stockholders' Equity

Common Stock and Stockholders' Equity

9. Common Stock and Stockholders’ Equity

Common stock

In December 2022, in a registered direct equity offering to certain institutional and accredited investors, including GMS Ventures and Investments (“GMS Ventures”), the Company’s largest stockholder, the Company issued 28,460,831 shares of common stock at a purchase price per share of $0.8784 for $23,547,904 in net proceeds after payment of placement agent fees and other offering costs. GMS Ventures purchased an aggregate of 14,230,418 shares of common stock in the registered direct equity offering. In connection with the registered direct equity offering, the Company issued to M.S. Howells & Co., the placement agent, warrants to purchase up to an aggregate of 515,755 shares of common stock at an exercise price of $1.05 per share, which warrants have a three-year term.

In November 2021, the Company issued 46,000,000 shares of common stock in an underwritten public offering at a purchase price per share of $1.25 for $53,968,057 in net proceeds after payment of underwriter discounts and commissions and other underwriter offering costs. GMS Ventures purchased an aggregate of 16,000,000 shares of common stock in the public offering at the public offering price per share. In connection with the underwritten public offering, the Company issued the underwriter warrants to purchase up to an aggregate of 2,100,000 shares of common stock at an exercise price of $1.5625 per share, which warrants have a five-year term.

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

On March 26, 2021, the Company entered into the ATM Offering with Wainwright under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $40,000,000 from time to time through Wainwright. The Company incurred financing costs of $197,654, which were capitalized and are being reclassified to additional paid in capital on a pro rata basis when the Company sells common stock under the ATM Offering. As of December 31, 2022, $113,848 of such deferred costs are included in other assets on the consolidated balance sheets.

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

During the three months ended December 31, 2022, the Company sold 895,391 shares of common stock under the ATM Offering and generated $1,127,904 in gross proceeds. The Company paid fees to the Agent and other issuance costs of $38,799. During the three months ended December 31, 2021, the Company sold 1,773,974 shares of common stock under the ATM Offering and generated $3,622,497 in gross proceeds. The Company paid fees to the Agent and other issuance costs of $115,763.

Common stock warrants

As of December 31, 2022, 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
December 22, 2024	(i)	277,128	$	12.00
April 13, 2025	(i)	145,686	$	12.00
May 31, 2025	(i)	62,437	$	12.00
February 24, 2025		172,864	$	1.27
February 26, 2024		1,747,047	$	0.9535
June 22, 2025		191,268	$	1.51875
January 28, 2026		2,116,364	$	1.25
November 23, 2026		2,100,000	$	1.5625
December 28, 2025		515,755	$	1.0500
		7,328,549

(i)

The warrants were issued in connection with the convertible senior secured notes originally issued pursuant to the certain Note and Warrant Purchase Agreement dated December 22, 2017 and are classified as liabilities on the accompanying consolidated balance sheets, as the warrants include cash settlement features at the option of the holders under certain circumstances. Refer to Note 4 for fair value measurements disclosures.

- Definition

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

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+ Details

Consolidated Balance Sheets (Parentheticals) - $ / shares	Dec. 31, 2022	Sep. 30, 2022
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	256,666,794	227,310,572
Common stock, shares outstanding	256,666,794	227,310,572
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
Convertible preferred stock outstanding	0	0
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

Basis of Presentation and Summary of Significant Accounting Policies

3 Months Ended

Dec. 31, 2022

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 December 31, 2022 and its results of operations for the three months ended December 31, 2022 and 2021, cash flows for the three months ended December 31, 2022 and 2021, and stockholders’ equity for the three months ended December 31, 2022 and 2021. Operating results for the three months ended December 31, 2022 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2023. The unaudited interim consolidated financial statements presented herein do not contain all of 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, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 29, 2022.

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, such as the current macroeconomic environment, including as a result of the ongoing COVID-19 pandemic or political disruption such as the war between Ukraine and Russia, 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. Potentially dilutive securities include warrants, performance-based stock options and units, stock options and non-vested restricted stock unit (“RSU”) awards using the treasury stock method. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares due to the Company’s loss.

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


	Three months ended December 31,
	2022		2021
Net loss attributable to common stockholders	$	(18,662,513)	$	(14,462,729)
Common stock shares outstanding (weighted average)		227,410,533		188,157,921
Basic and diluted net loss per share	$	(0.08)	$	(0.08)

The following potentially dilutive securities (in common stock equivalents) have been excluded from the computation of diluted weighted-average shares outstanding as of December 31, 2022, and 2021, as they would be antidilutive:


	As of December 31,
	2022		2021
Performance-based stock units	2,470		2,470
Performance-based stock options	1,900,000		1,900,000
Stock options	20,726,330		17,904,189
Common stock warrants	7,328,549		7,228,829
Convertible debt	15,910,000	⁽ⁱ⁾	—

(i)

The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $2.00 per share, which is subject to change as described in Note 7.

Recently issued accounting pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815 - 40). ASU 2020-06 eliminated the beneficial conversion and cash conversion accounting models in ASC 470-20 that required separate accounting for embedded conversion features and simplifies the settlement assessment to determine whether a contract qualifies for equity classification. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares. The Company adopted ASU 2020-06 on October 1, 2022 using the modified retrospective approach and applied the guidance to all financial instruments that were outstanding as of the beginning of 2022. There was no cumulative effect adjustment to the opening balance of retained earnings as a result of adopting ASU 2020-06.

There have been no other accounting pronouncements issued but not yet adopted by the Company which are expected to have a material impact on the Company’s consolidated financial position, results of operations or cash flows.

Fair Value Measurements (Tables)

3 Months Ended

Dec. 31, 2022

Fair Value Measurements

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


	December 31, 2022
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Unsecured convertible promissory note	$	—	$	—	$	31,820,000
Warrant liability		—		—		26,878
Total	$	—	$	—	$	31,846,878


	September 30, 2022
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	57,138

Schedule of changes in the fair value of Level 3 valuation for the warrant liability


	Unsecured Convertible
	Promissory Note		Warrants
Balance at October 1, 2022	$	—	$	57,138
Fair value at issuance date		31,820,000		—
Change in fair value		—		(30,260)
Balance at December 31, 2022	$	31,820,000	$	26,878

Schedule of fair value of the warrant liability


	December 31, 2022			September 30, 2022
Risk-free interest rate		4.39	%		4.23	%
Remaining contractual term of warrants (years)		2.1			2.4
Expected volatility		88.5	%		92.5	%
Annual dividend yield		—	%		—	%
Fair value of common stock (per share)	$	1.08		$	1.22

Fair Value Measurements (Details) - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Liabilities
Derivative Liability, Statement of Financial Position [Extensible Enumeration]	Warrants and Rights Outstanding	Warrants and Rights Outstanding
Fair value measurements recurring basis \| Level 3
Liabilities
Unsecured convertible promissory note	$ 31,820,000
Warrant liability	26,878	$ 57,138
Fair value of liabilities	$ 31,846,878

Equity Method Investment

3 Months Ended

Dec. 31, 2022

Equity Method Investment

Equity Method Investment

5. Equity Method Investment

In connection with the execution of a stock purchase agreement with Syntone Ventures LLC (“Syntone Ventures”), the United States-based affiliate of Syntone Technologies Group Co. Ltd. (“Syntone PRC”) on May 22, 2020, the Company and Syntone PRC entered into a joint venture agreement pursuant to which they agreed to form a People’s Republic of China (“PRC”) joint venture, Beijing Syntone Biopharma Ltd (“Syntone”), that is 80% owned by Syntone PRC and 20% owned by the Company. As the Company can exert significant influence over, but does not control, Syntone’s operations through voting rights or representation on Syntone’s board of directors, the Company accounts for this investment using the equity method of accounting. Upon formation of Syntone in April 2021, the Company entered into a royalty-free license with Syntone for the development, commercialization and manufacture of ONS-5010 in the greater China market, which includes Hong Kong, Taiwan and Macau.

The Company made the initial investment of $900,000 in June 2020 and expects to be required to make an additional capital contribution to Syntone of approximately $2,100,000, which will be made within four years after the establishment date in accordance with the development plan contemplated in the license agreement or on such other terms within such four-year period. The maximum exposure to a loss as a result of the Company’s involvement in Syntone is limited to the initial investment and the future capital contributions of approximately $2,100,000.

Common Stock and Stockholders' Equity (Tables)

3 Months Ended

Dec. 31, 2022

Common Stock and Stockholders' Equity

Schedule of warrants outstanding

As of December 31, 2022, 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
December 22, 2024	(i)	277,128	$	12.00
April 13, 2025	(i)	145,686	$	12.00
May 31, 2025	(i)	62,437	$	12.00
February 24, 2025		172,864	$	1.27
February 26, 2024		1,747,047	$	0.9535
June 22, 2025		191,268	$	1.51875
January 28, 2026		2,116,364	$	1.25
November 23, 2026		2,100,000	$	1.5625
December 28, 2025		515,755	$	1.0500
		7,328,549

(i)

Accrued Expenses (Tables)

3 Months Ended

Dec. 31, 2022

Accrued Expenses

Schedule of accrued expenses



	December 31, 2022		September 30, 2022
Compensation	$	2,503,382	$	1,976,252
Research and development		5,121,215		744,154
Professional fees		1,345,561		564,423
Commercial consulting		40,338		—
Other accrued expenses		17,143		143,071
	$	9,027,639	$	3,427,900

Accrued Expenses (Details) - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Accrued Expenses
Compensation	$ 2,503,382	$ 1,976,252
Research and development	5,121,215	744,154
Professional fees	1,345,561	564,423
Commercial consulting	40,338
Other accrued expenses	17,143	143,071
Accrued expenses, total	$ 9,027,639	$ 3,427,900

Debt

3 Months Ended

Dec. 31, 2022

Debt

Debt

7. Debt

Debt consists of:


	December 31, 2022		September 30, 2022
Unsecured convertible promissory note (measured at fair value)	$	31,820,000	$	—
Unsecured promissory note		—		11,114,518
Total debt		31,820,000		11,114,518
Less: unamortized loan costs		—		(199,503)
Total debt, net of unamortized loan costs		31,820,000		10,915,015
Less: current portion		—		(10,915,015)
Long-term debt	$	31,820,000	$	—

Unsecured convertible promissory note

On December 22, 2022, the Company entered into a Securities Purchase Agreement and issued the December 2022 Note with a face amount of $31,820,000, to Streeterville Capital, LLC (the “Lender”), the holder of the Company’s unsecured promissory note issued in November 2021 (the “November 2021 Note”). The December 2022 Note has an original issue discount of $1,820,000. The Company received net proceeds of $18,052,461 upon the closing on December 28, 2022 after deducting the Lender’s transaction costs in connection with the issuance and a full payment of the remaining outstanding principal and accrued interest on the November 2021 Note. The November 2021 Note was cancelled upon repayment. See

below for additional disclosures relating to November 2021 Note. The December 2022 Note bears interest at 9.5% per annum and matures on January 1, 2024. The December 2022 Note contains customary covenants, including a restriction on the Company’s ability to pledge certain of the Company’s assets, subject to certain exceptions, without the Lender’s consent. Beginning on April 1, 2023, the Lender will have the right to convert the December 2022 Note at the Conversion Price (as defined below). The principal amount and conversion price of the December 2022 Note are subject to adjustment upon certain triggering events. In addition, the Company has the right to convert all or any portion of the outstanding balance under the December 2022 Note into shares of common stock at the Conversion Price if certain conditions have been met at the time of conversion, including if at any time after the six-month anniversary of the closing date, the daily volume-weighted average price of the common stock on Nasdaq equals or exceeds $2.50 per share (subject to adjustments for stock splits and stock combinations) for a period of 30 consecutive trading days. Payments may be made by the Company (i) in cash, (ii) in shares of common stock, with the number of shares being equal to the portion of the applicable payment amount divided by the Conversion Price (as defined below), or (iii) a combination of cash and shares of common stock. Any payments made by the Company in cash, including prepayments or repayment at maturity, will be subject to an additional fee of 7.5%. Upon the occurrence of certain events described in the December 2022 Note, including, among others, the Company’s failure to pay amounts due and payable under the December 2022 Note, events of insolvency or bankruptcy, failure to observe covenants contained in the Securities Purchase Agreement and the December 2022 Note, breaches of representations and warranties in the Securities Purchase Agreement, and the occurrence of certain transactions without the Lender’s consent, each such event, a Trigger Event, the Lender shall have the right, subject to certain exceptions, to increase the balance of the December 2022 Note by 10% for a Major Trigger Event (as defined in the December 2022 Note) and 5% for a Minor Trigger Event (as defined in the December 2022 Note). If a Trigger Event is not cured within ten (10) trading days of written notice thereof from the Lender, it will result in an event of default (such event, an “Event of Default”). Following an Event of Default, the Lender may accelerate the December 2022 Note such that all amounts thereunder become immediately due and payable, and interest shall accrue at a rate of 22% annually until paid. Under the December 2022 Note, “Conversion Price” means, prior to a Major Trigger Event, $2.00 per share (subject to adjustment for stock splits and stock combinations), and following a Major Trigger Event, the lesser of (i) $2.00 per share (subject to adjustment for stock splits and stock combinations), and (ii) 90% multiplied by the lowest closing bid price of the Company’s common stock in the three trading days prior to the date on which the conversion notice is delivered. In February 2023, the December 2022 Note was amended to provide that if the Conversion Price is below $0.1756 per share, the Company will be required to satisfy a conversion notice from the Lender in cash. While the December 2022 Note is outstanding, the Lender will have a consent right on any future variable rate transactions or any debt. Lender will also have a 10% participation right in any future debt or equity financings.

The Company elected to account for the December 2022 Note at fair value (Note 4) and was not required to bifurcate the conversion option as a derivative and as result the original issue discount of $1,820,000 and debt issuance costs were written off upon election to fair value and accounted for as interest. During the three months ended December 31, 2022 the Company recognized $2,074,964 of interest expense related to the December 2022 Note related to original issue discount of $1,820,000 and other third party debt issuance costs of $254,964 as the Company elected the fair value option.

Unsecured promissory note

On November 16, 2021, the Company received $10,000,000 in net proceeds from the issuance of the November 2021 Note with a face amount of $10,220,000. Debt issuance costs totaling $820,000 were recorded as debt discount and were deducted from the principal in the accompanying consolidated balance sheet as of September 30, 2022. The debt discount was amortized as a component of interest expense over the term of the underlying debt using the effective interest method. The November 2021 Note bore interest at a rate of 9.5% per annum compounding daily and was set to mature on January 1, 2023. The Company could prepay all or a portion of the November 2021 Note at any time by paying 105% of the outstanding balance elected for pre-payment.

As discussed above, the November 2021 Note was cancelled using proceeds from the December 2022 Note issued to the same lender. The total repayment was $11,947,539, which represented 105% of the outstanding balance and included $1,158,609 of interest expense. The transaction has been accounted for as an extinguishment of the November 2021 Note.

As a result, the Company recorded a loss on debt extinguishment of $577,659, which included $8,729 of unamortized debt discount, and prepayment fees of $568,930.

During the three months ended December 31, 2022 and 2021, the Company recognized $454,866 and $344,716, respectively, of interest expense related to the November 2021 Note of which $190,775 and $108,123, respectively, were related to the amortization of debt discount.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (c)
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Section 50
-Paragraph 1I
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-SubTopic 20
-Section 50
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
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-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

+ Details

Liquidity (Details) - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Liquidity
Accumulated deficit	$ 427,598,031	$ 408,935,518
Long-term debt including interest	$ 31,845,197

Stock-Based Compensation - Option Assumptions (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Stock options
Share-based Compensation
Risk-free interest rate	3.90%	1.30%
Expected term (years)	5 years 3 months 18 days	6 years
Expected volatility	115.00%	94.30%
Expected dividend yield	0.00%	0.00%
Unrecognized compensation expense	$ 10,218,182
Unrecognized compensation exercise period	2 years 4 months 24 days
Performance-based stock options
Share-based Compensation
Risk-free interest rate	3.80%	1.30%
Expected term (years)	10 years	5 years 2 months 12 days
Expected volatility	91.30%	91.50%
Expected dividend yield	0.00%	0.00%

Stock-Based Compensation - Non-options (Details) - Performance-based stock units	3 Months Ended
	Dec. 31, 2022 $ / shares shares
Share-based Compensation
Term of award	10 years
Number of PSUs
Balance, Beginning \| shares	2,470
Forfeitures \| shares
Balance, Ending \| shares	2,470
Vested and exercisable \| shares	2,470
Weighted Average Base Price Per Unit
Balance, Beginning \| $ / shares	$ 49.97
Forfeitures \| $ / shares
Balance, Ending \| $ / shares	49.97
Vested and exercisable \| $ / shares	$ 49.97
Weighted average remaining contractual term, Outstanding	1 year 9 months 18 days
Weighted average remaining contractual term, Vested and exercisable	1 year 9 months 18 days

Fair Value Measurements - Assumptions (Details)	Dec. 31, 2022 $ / shares Y	Dec. 31, 2021 $ / shares Y
Risk-free interest rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	4.39	4.23
Remaining contractual term of warrants (years)
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs \| Y	2.1	2.4
Expected volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	88.5	92.5
Annual dividend yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs	0	0
Fair value of common stock (per share)
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant inputs \| $ / shares	1.08	1.22

Commitments and Contingencies - Lease minimum payments (Details) - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Operating leases
2023	$ 15,814
Total undiscounted lease payments	15,814
Less: Imputed interest	241
Total lease obligations	15,573	$ 26,995
Finance leases
2023	9,862
2024	4,383
Total undiscounted lease payments	14,245
Less: Imputed interest	1,024
Total lease obligations	$ 13,221	$ 16,018

Commitments and Contingencies (Tables)

3 Months Ended

Dec. 31, 2022

Commitments and Contingencies.

Schedule of lease information

The components of lease cost for the three months ended December 31, 2022 and 2021 are as follows:


	Three months ended December 31,
	2022		2021
Lease cost:
Amortization of right-of-use assets	$	—	$	—
Interest on lease liabilities		491		975
Total finance lease cost		491		975
Operating lease cost		11,217		11,217
Total lease cost	$	11,708	$	12,192

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


	December 31, 2022		September 30, 2022
Operating leases:
Right-of-use asset	$	59,582	$	70,360
Operating lease liabilities		15,573		26,995
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		13,221		16,018
Weighted-average remaining lease term (years):
Operating leases		1.3		1.6
Finance leases		1.0		1.3
Weighted-average discount rate:
Operating leases		7.5%		7.5%
Finance leases		13.0%		13.0%

Other information related to leases for the three months ended December 31, 2022 and 2021 are as follows:


	Three months ended December 31,
	2022		2021
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	491	$	975
Operating cash flows from operating leases		11,861		11,522
Financing cash flows from finance leases		2,797		6,801
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	—	$	—

Schedule of operating lease future minimum payments

Future minimum lease payments under non-cancelable leases as of December 31, 2022 are as follows for the years ending September 30:


	Operating leases		Finance leases
2023 (remaining nine months)	$	15,814	$	9,862
2024		—		4,383
Total undiscounted lease payments		15,814		14,245
Less: Imputed interest		241		1,024
Total lease obligations	$	15,573	$	13,221

Schedule of finance lease future minimum payments


	Operating leases		Finance leases
2023 (remaining nine months)	$	15,814	$	9,862
2024		—		4,383
Total undiscounted lease payments		15,814		14,245
Less: Imputed interest		241		1,024
Total lease obligations	$	15,573	$	13,221

Consolidated Statements of Stockholders' Equity - USD ($)	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Sep. 30, 2021	$ 1,764,616	$ 345,726,087	$ (342,883,254)	$ 4,607,449
Balance, beginning (in shares) at Sep. 30, 2021	176,461,628
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock in connection with exercise of stock options	$ 250	17,500		17,750
Issuance of common stock in connection with exercise of stock options (in shares)	25,000
Sale of common stock, net of issuance costs	$ 477,740	56,979,163		57,456,903
Sale of common stock, net of issuance costs (in shares)	47,773,974
Stock-based compensation expense		1,204,048		1,204,048
Net loss			(14,462,729)	(14,462,729)
Balance at Dec. 31, 2021	$ 2,242,606	403,926,798	(357,345,983)	48,823,421
Balance, ending (in shares) at Dec. 31, 2021	224,260,602
Balance at Sep. 30, 2022	$ 2,273,105	415,398,984	(408,935,518)	8,736,571
Balance, beginning (in shares) at Sep. 30, 2022	227,310,572
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Sale of common stock, net of issuance costs	$ 293,562	23,998,598		24,292,160
Sale of common stock, net of issuance costs (in shares)	29,356,222
Stock-based compensation expense		1,392,393		1,392,393
Net loss			(18,662,513)	(18,662,513)
Balance at Dec. 31, 2022	$ 2,566,667	$ 440,789,975	$ (427,598,031)	$ 15,758,611
Balance, ending (in shares) at Dec. 31, 2022	256,666,794

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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+ Details

Stock-Based Compensation - Stock option activity (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Other option information
Stock-based compensation expense	$ 1,392,393	$ 1,204,048
Stock options
Number of Shares
Balance, Beginning (in shares)	20,124,581
Granted (in shares)	601,749
Balance, Ending (in shares)	20,726,330
Exercisable (in shares)	10,587,559
Vested and expected to vest (in shares)	20,726,330
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 1.49
Granted (in dollars per share)	1.18
Balance, Ending (in dollars per share)	1.48
Exercisable (in dollars per share)	1.43
Vested and expected to vest (in dollars per share)	$ 1.48
Other option information
Balance-Remaining contractual term	8 years 1 month 6 days
Exercisable-Remaining contractual term	7 years 9 months 18 days
Vested and expected to vest-Remaining contractual term	8 years 1 month 6 days
Aggregate intrinsic value, Outstanding	$ 3,299,721
Aggregate intrinsic value, Exercisable	2,059,975
Aggregate intrinsic value, Vested and expected to vest	$ 3,299,721
Grant date fair value of options (in dollars per share)	$ 0.99	$ 1.16
Performance-based stock options
Number of Shares
Balance, Beginning (in shares)	700,000
Granted (in shares)	1,200,000
Balance, Ending (in shares)	1,900,000
Exercisable (in shares)	700,000
Vested and expected to vest (in shares)	700,000
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)	$ 1.44
Granted (in dollars per share)	1.04
Balance, Ending (in dollars per share)	1.19
Exercisable (in dollars per share)	1.44
Vested and expected to vest (in dollars per share)	$ 1.44
Other option information
Balance-Remaining contractual term	9 years 7 months 6 days
Exercisable-Remaining contractual term	8 years 10 months 24 days
Vested and expected to vest-Remaining contractual term	8 years 10 months 24 days
Term of award	10 years
Grant date fair value of options (in dollars per share)	$ 0.91	$ 1.03

Commitments and Contingencies - Lease balance sheet (Details) - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Leases
Operating leases, Right-of-use asset	$ 59,582	$ 70,360
Operating lease liabilities	15,573	26,995
Financing lease liabilities	$ 13,221	$ 16,018
Operating leases, Weighted-average remaining lease term	1 year 3 months 18 days	1 year 7 months 6 days
Finance leases, Weighted-average remaining lease term	1 year	1 year 3 months 18 days
Operating leases, Weighted-average discount rate (as a percent)	7.50%	7.50%
Finance leases, Weighted-average discount rate (as a percent)	13.00%	13.00%

Commitments and Contingencies - Lease cost (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Mar. 31, 2021
Leases
Finance lease term			3 years
Lease cost
Interest on lease liabilities	$ 491	$ 975
Total finance lease cost	491	975
Operating lease cost	11,217	11,217
Total lease cost	$ 11,708	$ 12,192
Minimum
Leases
Finance lease term	12 months
Finance lease interest (as a percent)	4.00%
Maximum
Leases
Finance lease term	36 months
Finance lease interest (as a percent)	13.00%

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

3 Months Ended

Dec. 31, 2022

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 loss per share and diluted loss per share:


	Three months ended December 31,
	2022		2021
Net loss attributable to common stockholders	$	(18,662,513)	$	(14,462,729)
Common stock shares outstanding (weighted average)		227,410,533		188,157,921
Basic and diluted net loss per share	$	(0.08)	$	(0.08)


	As of December 31,
	2022		2021
Performance-based stock units	2,470		2,470
Performance-based stock options	1,900,000		1,900,000
Stock options	20,726,330		17,904,189
Common stock warrants	7,328,549		7,228,829
Convertible debt	15,910,000	⁽ⁱ⁾	—

(i)

The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $2.00 per share, which is subject to change as described in Note 7.

Recently issued accounting pronouncements

Stock-Based Compensation - Restricted stock (Details)		1 Months Ended	3 Months Ended
Stock-Based Compensation - Restricted stock (Details)	Jan. 27, 2020 item shares	Mar. 31, 2020 item $ / shares shares	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense \| $			$ 1,392,393	$ 1,204,048
MTTR, LLC ("MTTR")
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of principals \| item	4
Shares issued during period \| shares	7,244,739
Restricted Stock \| MTTR, LLC ("MTTR")
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of principals \| item		4
Shares issued during period \| shares		7,244,739
Share repurchase price \| $ / shares		$ 0.01
Grant date fair value of share \| $ / shares		$ 0.54
Explicit service period		4 years 9 months 18 days
Stock-based compensation expense \| $				$ 151,764
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)			3 Months Ended
Related-Party Transactions (Details)	Dec. 21, 2021 USD ($) shares	Jan. 27, 2020 USD ($) individual item shares	Dec. 31, 2022 USD ($) shares	Dec. 31, 2021 USD ($)	Sep. 30, 2022 USD ($)
Related Party Transaction [Line Items]
Number Of Executive Officers \| individual		2
Performance-based stock options
Related Party Transaction [Line Items]
Number of shares granted			1,200,000
MTTR, LLC ("MTTR")
Related Party Transaction [Line Items]
Number of principals \| item		4
Shares issued during period		7,244,739
Contract termination settlement fee \| $		$ 110,000
Related party expense \| $			$ 58,069	$ 313,986
Due to related party, current \| $			$ 18,333		$ 18,333
Employment agreement \| Performance-based stock options
Related Party Transaction [Line Items]
Number of stock options vested			200,000
Employment agreement \| Terry Dagnon
Related Party Transaction [Line Items]
Base salary \| $	$ 450,000
Percentage of cash bonus	50.00%
Employment agreement \| Terry Dagnon \| Stock option
Related Party Transaction [Line Items]
Number of shares granted	800,000
Employment agreement \| Terry Dagnon \| Performance-based stock options
Related Party Transaction [Line Items]
Number of shares granted	200,000
Employment agreement \| Jeff Evanson
Related Party Transaction [Line Items]
Base salary \| $	$ 450,000
Percentage of cash bonus	50.00%
Employment agreement \| Jeff Evanson \| Stock option
Related Party Transaction [Line Items]
Number of shares granted	800,000
Employment agreement \| Jeff Evanson \| Performance-based stock options
Related Party Transaction [Line Items]
Number of shares granted	200,000

Equity Method Investment - Syntone (Details) - Syntone - USD ($)		1 Months Ended
	May 22, 2020	Jun. 30, 2020
Investments
Ownership percentage	20.00%
Investment in joint venture		$ 900,000
Expected future investment	$ 2,100,000
Contract period	4 years
Syntone PRC
Investments
Ownership percentage	80.00%

Consolidated Balance Sheets - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Current assets:
Cash and cash equivalents	$ 52,340,848	$ 17,396,812
Prepaid expenses and other current assets	9,335,123	10,123,634
Total current assets	61,675,971	27,520,446
Operating lease right-of-use assets, net	59,582	70,360
Equity method investment	826,435	804,930
Other assets	126,442	132,015
Total assets	62,688,430	28,527,751
Current liabilities:
Current portion of long-term debt		10,915,015
Current portion of finance lease liabilities	12,137	11,751
Current portion of operating lease liabilities	15,573	26,995
Accounts payable	4,169,879	3,491,485
Accrued expenses	9,027,639	3,427,900
Income taxes payable	1,856,629	1,856,629
Total current liabilities	15,081,857	19,729,775
Long-term debt	31,820,000
Finance lease liabilities	1,084	4,267
Warrant liability	26,878	57,138
Total liabilities	46,929,819	19,791,180
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; 256,666,794 and 227,310,572 shares issued and outstanding at December 31, 2022 and September 30, 2022, respectively	2,566,667	2,273,105
Additional paid-in capital	440,789,975	415,398,984
Accumulated deficit	(427,598,031)	(408,935,518)
Total stockholders' equity	15,758,611	8,736,571
Total liabilities, convertible preferred stock and stockholders' equity	62,688,430	28,527,751
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

Common Stock and Stockholders' Equity - Common Stock (Details) - USD ($)		1 Months Ended		3 Months Ended
	Mar. 26, 2021	Dec. 31, 2022	Nov. 30, 2021	Dec. 31, 2022	Dec. 31, 2021	Sep. 30, 2022
Stockholders' Equity
Shares of common stock issuable upon exercise of warrants		7,328,549		7,328,549
Proceeds from issuance of stock				$ 24,637,009	$ 57,654,776
Common stock, shares authorized		325,000,000		325,000,000		325,000,000
Underwritten Public Offering
Stockholders' Equity
Number of share issued			46,000,000
Shares of common stock issuable upon exercise of warrants			2,100,000
Shares issued price (in dollars per share)			$ 1.25
Proceeds from issuance of stock			$ 53,968,057
Exercise price per share			$ 1.5625
Warrants exercise term			5 years
Underwritten Public Offering \| GMS Ventures & Investments
Stockholders' Equity
Number of share issued			16,000,000
Direct registered offering
Stockholders' Equity
Number of share issued		28,460,831
Shares issued price (in dollars per share)		$ 0.8784		$ 0.8784
Proceeds from issuance of stock		$ 23,547,904
Direct registered offering \| GMS Ventures & Investments
Stockholders' Equity
Number of share issued		14,230,418
Direct registered offering \| M.S. Howells & Co
Stockholders' Equity
Shares of common stock issuable upon exercise of warrants		515,755		515,755
Exercise price per share		$ 1.05		$ 1.05
Warrants exercise term		3 years		3 years
ATM Offering
Stockholders' Equity
Number of share issued				895,391	1,773,974
Proceeds from issuance of stock				$ 1,127,904	$ 3,622,497
Aggregate offering price	$ 40,000,000
Amount reclassified on additional paid in capital	$ 197,654
Deferred costs		$ 113,848		113,848
Percentage of commission on sale of common stock	3.00%
Payment of fees to sales agent				$ 38,799	$ 115,763

Commitments and Contingencies - Lease cash flow (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Leases
Operating cash flows from finance leases	$ 491	$ 975
Operating cash flows from operating leases	11,861	11,522
Financing cash flows from finance leases	$ 2,797	$ 6,801

Debt - Information (Details) - USD ($)			3 Months Ended
Debt - Information (Details) - USD ($)	Dec. 22, 2022	Nov. 16, 2021	Dec. 31, 2022	Dec. 31, 2021	Sep. 30, 2022
Debt
Proceeds from loan			$ 30,000,000	$ 10,000,000
Total payment of lender fees			568,930	600,000
Unamortized discount					$ 199,503
Interest paid			1,158,609
Gain (loss) on extinguishment of debt			(577,659)	(1,025,402)
Unsecured promissory note December 2022
Debt
Original principal amount	$ 31,820,000
Proceeds from loan	$ 18,052,461
Interest rate (as a percent)	9.50%
Conversion rate per share	$ 2.50
Trading day threshold	30
Interest expense	$ 2,074,964
Debt issuance costs	1,820,000
Third party debt issuance costs	$ 254,964
Unsecured promissory note November 2021
Debt
Original principal amount		$ 10,220,000
Proceeds from loan		$ 10,000,000
Interest rate (as a percent)		9.50%
Interest expense			454,866	344,716
Unamortized discount		$ 820,000
Redemption price (as a percent)	105.00%	105.00%
Repayments of unsecured debt	$ 11,947,539
Amortization of debt issuance costs	8,729		$ 190,775	$ 108,123
Interest paid	1,158,609
Gain (loss) on extinguishment of debt	(577,659)
Prepayment fee	$ 568,930

Debt - Summary (Details) - USD ($)	Dec. 31, 2022	Sep. 30, 2022	Nov. 16, 2021
Debt Instrument [Line Items]
Total debt	$ 31,820,000	$ 11,114,518
Less: unamortized loan costs		(199,503)
Total debt, net of unamortized loan costs	31,820,000	10,915,015
Less: current portion		(10,915,015)
Long-term debt	31,820,000
Unsecured promissory note December 2022
Debt Instrument [Line Items]
Total debt	$ 31,820,000
Unsecured promissory note November 2021
Debt Instrument [Line Items]
Total debt		$ 11,114,518
Less: unamortized loan costs			$ (820,000)

Liquidity

3 Months Ended

Dec. 31, 2022

Liquidity

Liquidity

2. Liquidity

The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $427,598,031 as of December 31, 2022. As of December 31, 2022, the Company had $31,845,197 of principal and accrued interest due under an unsecured convertible promissory note issued in December 2022 (the “December 2022 Note”), maturing on January 1, 2024. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

Management believes that the Company’s existing cash and cash equivalents as of December 31, 2022 will be sufficient to fund its operations through the anticipated approval of the BLA for ONS-5010 in the third calendar quarter of 2023 and into the fourth calendar quarter of 2023. Additional financing will be needed by the Company to fund its operations in the future and to commercially develop ONS-5010 and to develop any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations such as continuing to access capital through the current At-the-Market Offering Agreement (the “ATM Agreement” or the “ATM Offering”), dated March 26, 2021, with H.C. Wainwright & Co., as sales agent (“Wainwright” or the “Agent”) (refer to Note 9 for further details on the ATM Offering) and negotiating a potential extension of maturity for notes that are scheduled to mature in January 2024. These strategies may also include, but are not limited to, proceeds from potential licensing and/or marketing arrangements or collaborations with pharmaceutical or other companies, the issuance of equity securities, the issuance of additional debt, 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 successfully begin marketing of its product candidates or complete revenue-generating partnerships with other 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.

Consolidated Statements of Operations - USD ($)	3 Months Ended
Consolidated Statements of Operations - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Operating expenses:
Research and development	$ 9,862,424	$ 9,872,476
General and administrative	5,825,604	3,277,205
Loss from operations	(15,688,028)	(13,149,681)
(Income) loss on equity method investment	(21,505)	23,655
Interest expense, net	2,448,591	351,534
Loss on extinguishment of debt	577,659	1,025,402
Change in fair value of promissory notes		162,355
Change in fair value of warrant liability	(30,260)	(249,898)
Net loss	$ (18,662,513)	$ (14,462,729)
Per share information:
Net loss per share of common stock, basic (in dollars per share)	$ (0.08)	$ (0.08)
Net loss per share of common stock, diluted (in dollars per share)	$ (0.08)	$ (0.08)
Weighted average shares outstanding, basic (in shares)	227,410,533	188,157,921
Weighted average shares outstanding, diluted (in shares)	227,410,533	188,157,921

Fair Value Measurements

3 Months Ended

Dec. 31, 2022

Fair Value Measurements

Fair Value Measurements

4. Fair Value Measurements

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

●

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

●

Level 2 - Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

●

Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.

The following table presents the Company’s liabilities that are measured at fair value on a recurring basis:


	December 31, 2022
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Unsecured convertible promissory note	$	—	$	—	$	31,820,000
Warrant liability		—		—		26,878
Total	$	—	$	—	$	31,846,878


	September 30, 2022
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Warrant liability	$	—	$	—	$	57,138

The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrant liability and unsecured convertible promissory note for the three months ended December 31, 2022:


	Unsecured Convertible
	Promissory Note		Warrants
Balance at October 1, 2022	$	—	$	57,138
Fair value at issuance date		31,820,000		—
Change in fair value		—		(30,260)
Balance at December 31, 2022	$	31,820,000	$	26,878

As further described in Note 7, the Company elected the fair value option to account for the December 2022 Note. The fair value of the December 2022 Note at issuance and at December 31, 2022 approximates face value.

The warrants issued in connection with the convertible senior secured notes originally issued pursuant to that certain Note and Warrant Purchase Agreement dated December 22, 2017 are classified as liabilities on the accompanying consolidated balance sheets as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair value of the warrant liability is estimated using the Black-Scholes option pricing model using the following assumptions:


	December 31, 2022			September 30, 2022
Risk-free interest rate		4.39	%		4.23	%
Remaining contractual term of warrants (years)		2.1			2.4
Expected volatility		88.5	%		92.5	%
Annual dividend yield		—	%		—	%
Fair value of common stock (per share)	$	1.08		$	1.22

- 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

Debt (Tables)

3 Months Ended

Dec. 31, 2022

Debt

Schedule of debt


	December 31, 2022		September 30, 2022
Unsecured convertible promissory note (measured at fair value)	$	31,820,000	$	—
Unsecured promissory note		—		11,114,518
Total debt		31,820,000		11,114,518
Less: unamortized loan costs		—		(199,503)
Total debt, net of unamortized loan costs		31,820,000		10,915,015
Less: current portion		—		(10,915,015)
Long-term debt	$	31,820,000	$	—

- 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.

+ References

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+ Details

Document And Entity Information - shares	3 Months Ended
Document And Entity Information - shares	Dec. 31, 2022	Feb. 10, 2023
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Dec. 31, 2022
Document Transition Report	false
Entity File Number	001-37759
Entity Registrant Name	OUTLOOK THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	38-3982704
Entity Address, Address Line One	485 Route 1 South
Entity Address, Address Line Two	Building F, Suite 320
Entity Address, City or Town	Iselin
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08830
City Area Code	609
Local Phone Number	619-3990
Title of 12(b) Security	Common Stock
Trading Symbol	OTLK
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		256,666,794
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Amendment Flag	false

Stock-Based Compensation

3 Months Ended

Dec. 31, 2022

Stock-Based Compensation

Stock-Based Compensation

10. Stock-Based Compensation

2011 Equity Incentive Plan

The Company’s 2011 Equity Compensation Plan (the “2011 Plan”) provided for the Company to sell or issue restricted common stock, RSUs, performance-based awards (“PSUs”), cash-based awards or to grant stock options for the purchase of common stock to officers, employees, consultants and directors of the Company. The 2011 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board. As of December 31, 2022, PSUs representing 2,470 shares of the Company’s common stock were outstanding under the 2011 Plan. Effective with the December 2015 adoption of the 2015 Equity Incentive Plan, (the “2015 Plan”), no future awards under the 2011 Plan will be granted.

2015 Equity Incentive Plan

In December 2015, the Company adopted the 2015 Plan. The 2015 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards and other forms of equity compensation to Company employees, directors and consultants. The aggregate number of shares of common stock authorized for issuance pursuant to the Company’s 2015 Plan is 34,565,837. As of December 31, 2022, 11,744,855 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 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 months ended December 31, 2022 and 2021:


	Three months ended December 31,
	2022		2021
Research and development	$	290,656	$	252,395
General and administrative		1,101,737		951,653
	$	1,392,393	$	1,204,048

Stock options

As of December 31, 2022 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, 2022	20,124,581	$	1.49
Granted	601,749		1.18
Balance at December 31, 2022	20,726,330	$	1.48	8.1	$	3,299,721
Vested and exercisable at December 31, 2022	10,587,559	$	1.43	7.8	$	2,059,975
Vested and expected to vest at December 31, 2022	20,726,330	$	1.48	8.1	$	3,299,721

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

The weighted average grant date fair value of the options awarded to employees for the three months ended December 31, 2022 and 2021 was $0.99 and $1.16 per option, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:


	Three months ended December 31,
	2022		2021
Risk-free interest rate	3.9	%	1.3	%
Expected term (years)	5.3		6.0
Expected volatility	115.0	%	94.3	%
Expected dividend yield	—		—

As of December 31, 2022, there was $10,218,182 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 2.4 years.

Performance-based stock options

The Company granted certain officers of the Company option awards whose vesting is contingent upon meeting company-wide performance goals. The performance stock options were granted “at-the-money” and have a term of 10 years.

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

A summary of the activity under the performance share option plan as of December 31, 2022 and changes during the three months then ended are presented below.


				Weighted
				Average
		Weighted		Remaining
	Number of	Average		Contractual	Aggregate
	Shares	Exercise Price		Term (Years)	Intrinsic Value
Balance at October 1, 2022	700,000	$	1.44
Granted	1,200,000		1.04
Balance at December 31, 2022	1,900,000	$	1.19	9.6	$	—
Vested and exercisable at December 31, 2022	700,000	$	1.44	8.9	$	—
Vested and expected to vest at December 31, 2022	700,000	$	1.44	8.9	$	—

The weighted average grant date fair value of the performance stock options awarded during the three months ended December 31, 2022 and 2021, was $0.91 and $1.03 per option, respectively. As of December 31, 2022, the Company assessed that the performance conditions related to the performance options granted were not probable of achievement. The assessment was based on the relevant facts and circumstances and therefore no compensation costs were recognized. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions:


	Three months ended December 31,
	2022		2021
Risk-free interest rate	3.8	%	1.3	%
Expected term (years)	10.0		5.2
Expected volatility	91.3	%	91.5	%
Expected dividend yield	—		—

Performance-based stock units

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

The following table summarizes the activity related to PSUs during the three months ended December 31, 2022:


				Weighted
				Average
	Number	Base		Remaining
	of	Price		Contractual	Aggregate
	PSUs	Per PSU		Term (Years)	Intrinsic Value
Balance at October 1, 2022	2,470	$	49.97
Forfeitures	—		—
Balance at December 31, 2022	2,470	$	49.97	1.8	$	—
Vested and exercisable at December 31, 2022	2,470	$	49.97	1.8	$	—

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 11 for further details on the consulting agreements and terminated strategic partnership agreement. These shares may not be sold until the earlier of (i) six months following FDA approval of ONS-5010, (ii) the date the Company publicly announces not to pursue development of ONS-5010, (iii) a change in control or (iv) January 2025. In addition, the Company has the right to repurchase the shares for $0.01 per share if the consultant terminates his agreement other than for good reason or the Company terminates the agreement for cause. The repurchase right lapses, in tiered percentages, based upon the completion of enrollment of the Company’s NORSE TWO clinical trial of ONS-5010 by certain dates. The repurchase right may also lapse as to 50% or 100% of the shares if the Company enters into certain agreements pertaining to ONS-5010 that meet certain value thresholds or the Company’s share price meets certain predefined targets. The repurchase right also lapses as to 100% of the shares upon the earliest to occur of (i) filing of the BLA for ONS-5010, (ii) termination of the agreement by the consultant for good reason or by the Company other than for cause, (iii) in the event of disability, or (iv) upon a change in control.

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. The compensation expense was accelerated during the year ended September 30, 2022 as a result of the Company achieving certain performance conditions related to the Company’s BLA submission and the corresponding repurchase rights lapsing. During the three months ended December 31, 2021, the Company recognized compensation expense related to the restricted stock of $151,764. There was no expense recognized for the three months ended December 31, 2022 and as of December 31, 2022, there was no unrecognized compensation expense related to the restricted stock.

Stock-Based Compensation (Tables)

3 Months Ended

Dec. 31, 2022

Share-based Compensation

Schedule of stock-based compensation expense


	Three months ended December 31,
	2022		2021
Research and development	$	290,656	$	252,395
General and administrative		1,101,737		951,653
	$	1,392,393	$	1,204,048

Schedule of performance-based stock units activity


				Weighted
				Average
	Number	Base		Remaining
	of	Price		Contractual	Aggregate
	PSUs	Per PSU		Term (Years)	Intrinsic Value
Balance at October 1, 2022	2,470	$	49.97
Forfeitures	—		—
Balance at December 31, 2022	2,470	$	49.97	1.8	$	—
Vested and exercisable at December 31, 2022	2,470	$	49.97	1.8	$	—

Stock options

Share-based Compensation

Schedule of stock option activity


				Weighted
				Average
		Weighted		Remaining
	Number of	Average		Contractual	Aggregate
	Shares	Exercise Price		Term (Years)	Intrinsic Value
Balance at October 1, 2022	20,124,581	$	1.49
Granted	601,749		1.18
Balance at December 31, 2022	20,726,330	$	1.48	8.1	$	3,299,721
Vested and exercisable at December 31, 2022	10,587,559	$	1.43	7.8	$	2,059,975
Vested and expected to vest at December 31, 2022	20,726,330	$	1.48	8.1	$	3,299,721

Schedule of option assumptions


	Three months ended December 31,
	2022		2021
Risk-free interest rate	3.9	%	1.3	%
Expected term (years)	5.3		6.0
Expected volatility	115.0	%	94.3	%
Expected dividend yield	—		—

Performance-based stock options

Share-based Compensation

Schedule of stock option activity


				Weighted
				Average
		Weighted		Remaining
	Number of	Average		Contractual	Aggregate
	Shares	Exercise Price		Term (Years)	Intrinsic Value
Balance at October 1, 2022	700,000	$	1.44
Granted	1,200,000		1.04
Balance at December 31, 2022	1,900,000	$	1.19	9.6	$	—
Vested and exercisable at December 31, 2022	700,000	$	1.44	8.9	$	—
Vested and expected to vest at December 31, 2022	700,000	$	1.44	8.9	$	—

Schedule of option assumptions


	Three months ended December 31,
	2022		2021
Risk-free interest rate	3.8	%	1.3	%
Expected term (years)	10.0		5.2
Expected volatility	91.3	%	91.5	%
Expected dividend yield	—		—

Fair Value Measurements - Additional Information (Details) - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Fair Value Measurements
Carrying value	$ 31,820,000	$ 10,915,015

Organization and Description of Business

3 Months Ended

Dec. 31, 2022

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 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.

All development activities are currently active in support of the Company’s Biologics License Application (“BLA”) registration program for ONS-5010 for wet age-related macular degeneration (“wet AMD”). In fiscal year 2022, the Company submitted the BLA and received confirmation from the U.S. Food and Drug Administration (“FDA”) that the BLA had been accepted for filing with a goal date of August 29, 2023 for a review decision by the FDA. Additionally, the Company submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (“EMA”), which has been validated for review with an estimated decision date expected in early 2024.

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

3 Months Ended

Dec. 31, 2022

Basis of Presentation and Summary of Significant Accounting Policies

Schedule of computation of basic earnings per share and diluted earnings per share


	Three months ended December 31,
	2022		2021
Net loss attributable to common stockholders	$	(18,662,513)	$	(14,462,729)
Common stock shares outstanding (weighted average)		227,410,533		188,157,921
Basic and diluted net loss per share	$	(0.08)	$	(0.08)

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


	As of December 31,
	2022		2021
Performance-based stock units	2,470		2,470
Performance-based stock options	1,900,000		1,900,000
Stock options	20,726,330		17,904,189
Common stock warrants	7,328,549		7,228,829
Convertible debt	15,910,000	⁽ⁱ⁾	—

(i)

The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $2.00 per share, which is subject to change as described in Note 7.

Stock-Based Compensation - Information (Details)	3 Months Ended
Stock-Based Compensation - Information (Details)	Dec. 31, 2022 shares
Performance-based stock units
Share-based Compensation
Term of award	10 years
Performance-based stock options
Share-based Compensation
Term of award	10 years
2011 Equity Incentive Plan \| Performance-based stock units
Share-based Compensation
Awards outstanding	2,470
2015 Equity Incentive Plan
Share-based Compensation
Aggregate number of common stock authorized for issuance	34,565,837
Number of shares available for grant	11,744,855
Term of award	10 years
2015 Equity Incentive Plan \| Minimum
Share-based Compensation
Vesting period	1 year
2015 Equity Incentive Plan \| Maximum
Share-based Compensation
Vesting period	4 years

Related-Party Transactions

3 Months Ended

Dec. 31, 2022

Related-Party Transactions

Related-Party Transactions

11. 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.

In November 2018, the board of directors of the Company appointed Mr. Terry Dagnon as Chief Operations 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. Both Mr. Dagnon and Mr. Evanson were compensated directly by MTTR for services provided to the Company as the Company's Chief Operations Officer and Chief Commercial Officer, respectively, pursuant to the strategic partnership agreement until such agreement, as amended, was terminated effective March 19, 2020. The Company began compensating Mr. Dagnon and Mr. Evanson directly as consultants effective March 19, 2020

pursuant to their respective consulting agreements with the Company, which became effective March 19, 2020 following stockholder approval of the share issuances contemplated therein.

On January 27, 2020, the Company entered into a termination agreement and mutual release with MTTR to terminate the strategic partnership agreement. Pursuant to the agreement, the Company agreed (x) to issue to the four principals of MTTR (who include two of its named executive officers, Messrs. Dagnon and Evanson) an aggregate of 7,244,739 shares of its common stock, subject to stockholder approval, (y) to enter into consulting agreements with each of the four principals setting forth the terms of his respective compensation arrangement, and (z) to pay MTTR a one-time settlement fee of $110,000 upon effectiveness of the agreement.

Concurrently, the Company also entered into consulting agreements directly with each of the four principals of MTTR setting forth the terms of his respective compensation arrangement, as well as providing for certain transfer restrictions and repurchase rights applicable to the shares of common stock to be issued pursuant hereto. The termination agreement and the consulting agreements became effective upon stockholder approval of the share issuance on March 19, 2020. Refer to Note 10 for the accounting of the restricted stock issued and compensation expense recognized.

During the three months ended December 31, 2022 and 2021, MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate of $58,069 and $313,986, respectively, which includes monthly consulting fees and expense reimbursement, but excludes stock-based compensation related to restricted stock (Note 10). As of December 31, 2022 and September 30, 2022, an aggregate of $18,333, was due to the former MTTR principals as consultants, which is included in accounts payable in the accompanying consolidated balance sheets.

On December 21, 2021, the Company entered into employment agreements with each of Mr. Dagnon and Mr. Evanson, which superseded and replaced their prior consulting agreements. Pursuant to their new employment agreements, each of Mr. Dagnon and Mr. Evanson will receive a base salary of $450,000 and a discretionary annual cash bonus with a target amount equal to 50% of his respective base salary. In connection with their entry into the employment agreements, each of Mr. Dagnon and Mr. Evanson received a grant of 800,000 options to purchase common stock, one quarter of which will vest on the first anniversary of the grant and the remainder of which will vest in monthly installments over the succeeding three years, subject to their continued service through each vesting date. In addition, each of Mr. Dagnon and Mr. Evanson received a performance grant of 200,000 options to purchase common stock, which will vest upon the Company’s achievement of certain milestones. An aggregate of 200,000 performance-based stock options vested as a result of achieving the performance condition related to the Company’s BLA submission.

Common Stock and Stockholders' Equity - Warrants (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Warrants
Shares of common stock issuable upon exercise of warrants	7,328,549
Proceeds from issuance of stock	$ 24,637,009	$ 57,654,776
December 22, 2024
Warrants
Shares of common stock issuable upon exercise of warrants	277,128
Exercise price per share	$ 12.00
April 13, 2025
Warrants
Shares of common stock issuable upon exercise of warrants	145,686
Exercise price per share	$ 12.00
May 31, 2025
Warrants
Shares of common stock issuable upon exercise of warrants	62,437
Exercise price per share	$ 12.00
February 24, 2025
Warrants
Shares of common stock issuable upon exercise of warrants	172,864
Exercise price per share	$ 1.27
February 26, 2024
Warrants
Shares of common stock issuable upon exercise of warrants	1,747,047
Exercise price per share	$ 0.9535
June 22, 2025
Warrants
Shares of common stock issuable upon exercise of warrants	191,268
Exercise price per share	$ 1.51875
January 28, 2026
Warrants
Shares of common stock issuable upon exercise of warrants	2,116,364
Exercise price per share	$ 1.25
November 23, 2026
Warrants
Shares of common stock issuable upon exercise of warrants	2,100,000
Exercise price per share	$ 1.5625
December 28, 2025
Warrants
Shares of common stock issuable upon exercise of warrants	515,755
Exercise price per share	$ 1.0500

Fair Value Measurements - Changes in fair value (Details)	3 Months Ended
	Dec. 31, 2022 USD ($)
Unsecured convertible promissory note November 2020
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Fair value at issuance date	$ 31,820,000
Balance, ending	31,820,000
Warrant liability
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance, beginning	57,138
Change in fair value	$ (30,260)
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Change In Fair Value Of Redemption Feature
Balance, ending	$ 26,878

Consolidated Statements of Cash Flows - USD ($)	3 Months Ended
Consolidated Statements of Cash Flows - USD ($)	Dec. 31, 2022	Dec. 31, 2021
OPERATING ACTIVITIES
Net loss	$ (18,662,513)	$ (14,462,729)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	10,778	50,868
Loss on extinguishment of debt	577,659	1,025,402
Non-cash interest expense	2,529,830	344,716
Stock-based compensation	1,392,393	1,204,048
Change in fair value of promissory notes		162,355
Change in fair value of warrant liability	(30,260)	(249,898)
(Income) loss on equity method investment	(21,505)	23,655
Interest paid on debt	(1,158,609)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	788,509	(285,504)
Operating lease liability	(11,422)	(10,265)
Accounts payable	678,394	169,169
Accrued expenses	5,005,500	1,037,925
Net cash used in operating activities	(8,901,246)	(10,990,258)
FINANCING ACTIVITIES
Proceeds from the sale of common stock, net of issuance costs	24,637,009	57,654,776
Proceeds from debt	30,000,000	10,000,000
Proceeds from exercise of stock options		17,750
Payments of finance lease obligations	(2,797)	(6,801)
Repayment of debt	(10,220,000)	(401,867)
Payment of financing costs	(568,930)	(600,000)
Net cash provided by financing activities	43,845,282	66,663,858
Net increase in cash and cash equivalents	34,944,036	55,673,600
Cash and cash equivalents at beginning of year	17,396,812	14,477,324
Cash and cash equivalents at end of year	52,340,848	70,150,924
Supplemental disclosure of cash flow information
Cash paid for interest	1,159,008	20,155
Supplemental schedule of non-cash financing activities:
Debt issuance costs in accrued expenses	254,964
Common stock issuance costs in accrued expenses	339,275	179,985
Deferred offering costs amortization	$ 5,573	$ 17,888

Stock-Based Compensation - Expense (Details) - USD ($)	3 Months Ended
Stock-Based Compensation - Expense (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,392,393	$ 1,204,048
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	290,656	252,395
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 1,101,737	$ 951,653