0001558370-24-008318 | 10-Q | XBRL Viewer

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Commitments and Contingencies - Lease cash flow (Details) - USD ($)	6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Leases
Operating cash flows from finance leases	$ 116	$ 889
Operating cash flows from operating leases		23,721
Financing cash flows from finance leases	$ 4,267	$ 5,686

Fair Value Measurements - Changes in fair value (Details)	6 Months Ended
	Mar. 31, 2024 USD ($)
December 2022 Note
Liabilities fair value changes
Balance, beginning	$ 35,551,000
Promissory note extension fees added to outstanding balance	2,681,847
Principal and accrued interest converted to common stock	(3,000,000)
Change in fair value	$ 9,512,153
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	$ 44,745,000
Warrant liability
Liabilities fair value changes
Balance, beginning	6,219
Issued in connection with sale of common stock	89,510,165
Change in fair value	$ 49,668,159
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Fair Value Adjustment of Warrants
Balance, ending	$ 139,184,543

Basis of Presentation and Summary of Significant Accounting Policies - Dilutive (Details) - USD ($)	6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Antidilutive securities
Unsecured notes principal converted into common stock	$ 3,000,000
$12,000,000 Amount of Convertible Debt
Antidilutive securities
Unsecured notes principal converted into common stock	$ 12,000,000
Performance-based stock units
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	123	123
Performance-based stock options
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	669,000	95,000
Employee Stock Option [Member]
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	1,959,565	1,103,242
Common stock warrants
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	13,136,193	366,410
Convertible debt
Antidilutive securities
Antidilutive securities excluded from computation of earnings per share	2,304,391	815,262
Conversion rate per share		$ 40.00
Convertible debt \| $12,000,000 Amount of Convertible Debt
Antidilutive securities
Conversion rate per share	$ 7.00
Convertible debt \| fixed conversion price
Antidilutive securities
Conversion rate per share	$ 40.00

Liquidity

6 Months Ended

Mar. 31, 2024

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 $593,385,368 as of March 31, 2024, which raises 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.

On April 15, 2024, in a private placement with Syntone Ventures, LLC (“Syntone”), the Company issued 714,286 shares of common stock and accompanying warrants to purchase 1,071,429 shares of common stock for $5,000,000 in gross proceeds pursuant to a securities purchase agreement entered in January 2024. The warrants have an exercise price of $7.70 per share of common stock and will expire on April 15, 2029.

Management does not believe that the existing cash and cash equivalents as of March 31, 2024, combined with the proceeds from the Syntone private placement in April 2024, are sufficient to fund the Company’s operations through one year from the date of this Quarterly Report on Form 10-Q. As a result, there is substantial doubt about the Company’s ability to continue as a going concern and 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, including but not limited to, continuing to access capital through at-the-market offering agreements (refer to Note 9 for further details), 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.

However, management does believe that the existing cash and cash equivalents as of March 31, 2024, combined with $5,000,000 of gross proceeds from the Syntone private placement that closed in April 2024, when combined with the expected proceeds from the full exercise of warrants to purchase shares of common stock (subject to meeting the requirements for calling the associated warrants), would be sufficient to support the Company’s operations through 2025. For further details on the warrants to purchase shares of common stock, refer to Note 9. The Company’s consolidated financial statements do not include any adjustments that might be necessary if it is unable to continue as a going concern.

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.

Common Stock and Stockholders' Equity - Warrants (Details) - $ / shares	3 Months Ended
	Mar. 31, 2024	Apr. 15, 2024
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	13,136,193	1,071,429
Exercise price per share		$ 7.70
December 22, 2024
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	13,850
Exercise price per share	$ 240.00
February 24, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	8,642
Exercise price per share	$ 25.40
April 13, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	7,284
Exercise price per share	$ 240.00
May 31, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	3,121
Exercise price per share	$ 240.00
June 22, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	9,563
Exercise price per share	$ 30.38
December 28, 2025
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	25,787
Exercise price per share	$ 21.00
February 2, 2026
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	93,238
Exercise price per share	$ 25.00
January 28, 2026
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	12,576
Exercise price per share	$ 25.00
November 23, 2026
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	104,999
Exercise price per share	$ 31.25
March 18, 2029
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)	12,857,133
Exercise price per share	$ 7.70
Beneficial ownership exercise restriction, one (as a percent)	4.99%
Beneficial ownership exercise restriction, two (as a percent)	9.99%
Beneficial ownership exercise restriction, three (as a percent)	19.99%
Warrant holders exercise under certain conditions (as a percent)	20.00%

Basis of Presentation and Summary of Significant Accounting Policies

6 Months Ended

Mar. 31, 2024

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, 2024 and its results of operations for the three and six months ended March 31, 2024 and 2023, cash flows for the six months ended March 31, 2024 and 2023, and stockholders’ equity for the three and six months ended March 31, 2024 and 2023. Operating results for the six months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the full year ending September 30, 2024. 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, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on December 22, 2023.

Reverse stock-split

Effective on March 14, 2024, the Company amended its amended and restated certificate of incorporation to implement a one-for-twenty reverse stock split of its common stock. As a result of the reverse stock split, the Company made corresponding adjustments to the share amounts under its employee incentive plans, outstanding options, and common stock warrant agreements with third parties. The disclosure of common shares and per common share data in the accompanying consolidated financial statements and related notes reflect the reverse stock split for all periods presented.

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 inflation, high interest rates or ongoing overseas conflict, 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 convertible debt, 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 March 31,			Six months ended March 31,
	2024		2023		2024		2023
Net loss attributable to common stockholders	$	(114,288,943)	$	(6,654,286)	$	(125,467,182)	$	(25,316,799)
Common stock shares outstanding (weighted average)		14,270,289		12,833,330		13,638,126		12,093,889
Basic and diluted net loss per share	$	(8.01)	$	(0.52)	$	(9.20)	$	(2.09)

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, 2024 and 2023, as they would be antidilutive:


	As of March 31,
	2024		2023
Performance-based stock units	123		123
Performance-based stock options	669,000		95,000
Stock options	1,959,565		1,103,242
Common stock warrants	13,136,193		366,410
Convertible debt	2,304,391	⁽ⁱ⁾	815,262	⁽ⁱⁱ⁾

(i)

The calculation for potentially dilutive securities pertaining to convertible debt is as follows: $12,000,000 of outstanding principal and accrued interest as of March 31, 2024, is converted at a rate of $7.00, and the remaining amount is converted based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7.

(ii)

The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7.

Recently issued accounting pronouncements

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07, which is applicable to entities with a single reportable segment and will primarily require enhanced disclosures about significant segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning after December 31, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07 will have on its consolidated financial statements and disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 which is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated financial statements and disclosures.

Stock-Based Compensation (Tables)

6 Months Ended

Mar. 31, 2024

Share-based Compensation

Schedule of stock-based compensation expense


	Three months ended March 31,				Six months ended March 31,
	2024		2023		2024		2023
Research and development	$	236,960	$	322,268	$	468,376	$	612,924
General and administrative		1,073,547		1,061,137		2,114,742		2,162,874
	$	1,310,507	$	1,383,405	$	2,583,118	$	2,775,798

Schedule of performance-based stock units activity


				Weighted
				Average
	Number	Exercise		Remaining
	of	Price		Contractual	Aggregate
	PSUs	Per PSU		Term (Years)	Intrinsic Value
Balance at October 1, 2023	123	$	999.40
Forfeitures	—		—
Balance at March 31, 2024	123	$	999.40	0.3	$	—
Exercisable at March 31, 2024	123	$	999.40	0.3	$	—
Vested and expected to vest at March 31, 2024	123	$	999.40	0.3	$	—

Employee Stock Option [Member]

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, 2023	1,197,774	$	28.72
Granted	799,729		6.70
Forfeited	(29,605)		27.93
Expired	(8,333)		33.60
Balance at March 31, 2024	1,959,565	$	19.72	8.2	$	4,219,550
Exercisable at March 31, 2024	875,865	$	27.62	7.0	$	383,313
Vested and expected to vest at March 31, 2024	1,959,565	$	19.72	8.2	$	4,219,550

Schedule of option assumptions


	Six months ended March 31,
	2024		2023
Risk-free interest rate	4.3	%	3.7	%
Expected term (years)	6.0		5.7
Expected volatility	131.3	%	112.4	%
Expected dividend yield	—		—

Performance-based stock options

Share-based Compensation

Schedule of stock option activity


				Weighted
				Average
		Weighted		Remaining
	Number of	Average		Contractual	Aggregate
	Shares	Exercise Price		Term (Years)	Intrinsic Value
Balance at October 1, 2023	35,000	$	28.80
Granted	634,000		6.78
Balance at March 31, 2024	669,000	$	7.93	9.9	$	3,271,440
Exercisable at March 31, 2024	35,000	$	28.80	7.7	$	—
Vested and expected to vest at March 31, 2024	669,000	$	7.93	9.9	$	3,271,440

Schedule of option assumptions


	Six months ended March 31,
	2024		2023
Risk-free interest rate	4.3	%	3.8	%
Expected term (years)	10.0		10.0
Expected volatility	125.6	%	91.3	%
Expected dividend yield	—		—

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Mar. 31, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Pay vs Performance Disclosure - USD ($)	3 Months Ended				6 Months Ended
Pay vs Performance Disclosure - USD ($)	Mar. 31, 2024	Dec. 31, 2023	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2024	Mar. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (114,288,943)	$ (11,178,239)	$ (6,654,286)	$ (18,662,513)	$ (125,467,182)	$ (25,316,799)

- Definition

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

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+ Details

Debt

6 Months Ended

Mar. 31, 2024

Debt

Debt

7. Debt

Debt consists of:


	March 31, 2024		September 30, 2023
Unsecured convertible promissory note (measured at fair value)	$	44,745,000	$	35,551,000
Less: current portion		(44,745,000)		(35,551,000)
Long-term debt	$	—	$	—

December 2022 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.

In December 2023, the Company extended the maturity of the December 2022 Note from January 1, 2024 to April 1, 2024. The Company incurred a $475,000 extension fee, which was expensed and included in interest expense in the unaudited interim consolidated statement of operations.

The December 2022 Note bore interest at 9.5% per annum through April 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 had 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 were subject to adjustment upon certain triggering events. In addition, the Company had 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 $50.00 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. Prior to April 1, 2024, under the December 2022 Note, “Conversion Price” meant, prior to a Major Trigger Event, $40.00 per share (subject to adjustment for stock splits and stock combinations), and following a Major Trigger Event, the lesser of (i) $40.00 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. If the Conversion Price is below $3.51 per share, the Company will be required to satisfy a conversion notice from the Lender in cash. Subject to certain exceptions, while the December 2022 Note is outstanding, the Lender will have a consent right on any future variable rate transactions or any debt and a 10% participation right in any future debt or equity financings.

On January 22, 2024, the Company entered into an amendment to the December 2022 Note (the “Note Amendment”) with the Lender, which became effective on April 1, 2024 after satisfaction of certain conditions, including various required stockholder approvals and the closing of the private placement on March 18, 2024. The maturity of the December 2022 Note was extended to July 1, 2025. An extension fee of $2,681,847 (calculated as 7.5% of the outstanding balance of the December 2022 Note) was added to the outstanding balance on March 18, 2024. The extension fee was expensed in the quarter ended March 31, 2024 and included in interest expense in the unaudited interim consolidated statement of operations.

Under the Note Amendment, the initial conversion price with respect to $15,000,000 in aggregate principal amount of the December 2022 Note was changed to $7.00, the price per share in the private placement that closed on March 18, 2024. Effective April 1, 2024, the December 2022 Note bears interest at the prime rate (as published in the Wall Street Journal) plus 3% (subject to a floor of 9.5%) and the Company has an obligation to repay at least $3,000,000 of the outstanding balance of the December 2022 Note for each calendar quarter beginning with the second calendar quarter of 2024 (subject to adjustment for conversions by the Lender and to payment of an exit fee as set forth in the Note Amendment) and continuing until the December 2022 Note is repaid in full. As of March 31, 2024, the December 2022 Note was classified as current on the unaudited interim consolidated balance sheets as the Lender has the right to convert the December 2022 Note into equity until the entire outstanding balance has been paid off.

During the three and six months ended March 31, 2024, an aggregate of principal and accrued interest totaling $3,000,000 of the December 2022 Note was converted into 428,571 shares of the Company’s common stock.

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 a 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 six months ended March 31, 2023, the Company recognized $2,074,964 of interest expense related to the December 2022 Note, consisting of the 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.

During the three and six months ended March 31, 2024, the Company recorded $3,156,847 of interest expense in both periods, respectively. This interest expense was associated with the fees incurred for extending the debt.

November 2021 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. 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 and six months ended March 31, 2023, the Company recognized $418,388 and $454,866 of interest expense, respectively, related to the November 2021 Note of which $169,857 and $190,775, respectively, was related to the amortization of debt discount. During the three and six months ended March 31, 2024, no interest expense was recognized.

- 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://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Section 50
-Paragraph 1B
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stock-Based Compensation - Expense (Details) - USD ($)	3 Months Ended		6 Months Ended
Stock-Based Compensation - Expense (Details) - USD ($)	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Mar. 31, 2023
Share-based Compensation
Stock-based compensation expense	$ 1,310,507	$ 1,383,405	$ 2,583,118	$ 2,775,798
Research and development
Share-based Compensation
Stock-based compensation expense	236,960	322,268	468,376	612,924
General and administrative
Share-based Compensation
Stock-based compensation expense	$ 1,073,547	$ 1,061,137	$ 2,114,742	$ 2,162,874

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Stock-Based Compensation - Option Assumptions (Details) - USD ($)	6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Employee Stock Option [Member]
Share-based Compensation
Risk-free interest rate	4.30%	3.70%
Expected term (years)	6 years	5 years 8 months 12 days
Expected volatility	131.30%	112.40%
Expected dividend yield	0.00%	0.00%
Unrecognized compensation expense	$ 10,784,269
Unrecognized compensation exercise period	1 year 7 months 6 days
Performance-based stock options
Share-based Compensation
Risk-free interest rate	4.30%	3.80%
Expected term (years)	10 years	10 years
Expected volatility	125.60%	91.30%
Expected dividend yield	0.00%	0.00%

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Fair Value Measurements - Assumptions (Details)	Mar. 31, 2024 $ / shares Y	Sep. 30, 2023 $ / shares Y
Expected Term
Fair value inputs
Debt inputs \| Y	1.3	0.3
Warrant inputs \| Y	5.0	1.4
Stock price (per share)
Fair value inputs
Debt inputs \| $ / shares	11.94	4.40
Warrant inputs \| $ / shares	11.94	4.40
Expected volatility
Fair value inputs
Debt inputs	1.670	0.710
Warrant inputs	1.354	1.583
Risk-free interest rate
Fair value inputs
Debt inputs	0.049	0.055
Warrant inputs	0.0421	0.0530
Annual dividend yield
Fair value inputs
Debt inputs	0	0
Warrant inputs	0	0
Discount rate
Fair value inputs
Debt inputs	0.217	0.228

Commitments and Contingencies

6 Months Ended

Mar. 31, 2024

Commitments and Contingencies

Commitments and Contingencies

8. Commitments and Contingencies

Litigation

On November 3, 2023, a securities class action lawsuit was filed against the Company and certain of its officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by the Company related to the Company’s BLA during the period from December 29, 2022 through August 29, 2023. The complaint alleges, among other things, that the Company violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010 as a treatment for wet AMD and that the Company and/or their manufacturing partner had deficient CMC controls for ONS-5010, which remained unresolved at the time the Company’s BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve the Company’s BLA, and that the Company’s stock price dropped when such information was disclosed. The plaintiffs in the class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees.

The pending lawsuit and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the pending lawsuit and any other related lawsuits is necessarily uncertain. The Company could be forced to expend significant resources in the defense of the pending lawsuit and any additional lawsuits, and the Company may not prevail. In addition, the Company may incur substantial legal fees and costs in connection with such lawsuits. The Company currently is not able to estimate the possible cost to it from these matters, as the pending lawsuit is currently at an early stage, and the Company cannot be certain how long it may take to resolve the pending lawsuit or the possible amount of any damages that the Company may be required

to pay. Such amounts could be material to the Company’s financial statements if it does not prevail in the defense of the pending lawsuit and any other related lawsuits, or even if it does prevail. The Company has not established any reserve for any potential liability relating to the pending lawsuit and any other related lawsuits. It is possible that the Company could, in the future, incur judgments or enter into settlements of claims for monetary damages.

Leases

Corporate office

In March 2021, the Company entered into a three-year term corporate office lease for its former corporate headquarters in Iselin, New Jersey that ended on April 30, 2024.

In March 2024, the Company entered into a five-year term corporate office lease for its new corporate headquarters in Iselin, New Jersey that commenced on May 1, 2024. The Company did not recognize a right-of-use asset and related operate lease liability as of March 31, 2024 because the lease had not commenced.

Equipment leases

As of March 31, 2024, all equipment leases had expired. The Company had equipment leases, with terms between 12 and 36 months, recorded as finance leases. The equipment leases bore interest between 4.0% and 13.0% per annum. Certain lease agreements contained provisions for future rent increases. Payments due under the lease contracts included minimum payments that the Company was obligated to make under the non-cancelable initial terms of the leases as the renewal terms are at the Company’s option. Lease expense was 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, 2024 and 2023 are as follows:


	Three months ended March 31,				Six months ended March 31,
	2024		2023		2024		2023
Lease cost:
Amortization of right-of-use assets	$	—	$	—	$	—	$	—
Interest on lease liabilities		12		398		116		889
Total finance lease cost		12		398		116		889
Operating lease cost		11,217		11,216		22,433		22,433
Total lease cost	$	11,229	$	11,614	$	22,549	$	23,322

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


	March 31, 2024		September 30, 2023
Operating leases:
Right-of-use asset	$	3,739	$	26,172
Operating lease liabilities		—		—
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		—		4,267
Weighted-average remaining lease term (years):
Operating leases		0.1		0.6
Finance leases		—		0.3
Weighted-average discount rate:
Operating leases		7.5%		7.5%
Finance leases		—		13.0%

Other information related to leases for the six months ended March 31, 2024 and 2023 are as follows:


	Six months ended March 31,
	2024		2023
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	116	$	889
Operating cash flows from operating leases		—		23,721
Financing cash flows from finance leases		4,267		5,686

As of March 31, 2024, there were no remaining future minimum lease payments under non-cancelable leases.

Consolidated Statements of Cash Flows (unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Mar. 31, 2023
OPERATING ACTIVITIES
Net loss	$ (114,288,943)	$ (6,654,286)	$ (125,467,182)	$ (25,316,799)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			56,390	21,779
Loss on extinguishment of debt				577,659
Non-cash interest expense			2,681,847	2,529,830
Stock-based compensation			2,583,118	2,775,798
Change in fair value of promissory notes	8,519,153	3,000	9,512,153	3,000
Warrants related expenses (Note 9)	34,097,568		34,097,568
Change in fair value of warrant liability	49,614,817	(18,615)	49,668,159	(48,875)
Loss (income) on equity method investment	30,595	16,965	28,047	(4,540)
Interest paid on debt				(1,158,609)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			(2,969,480)	713,199
Other assets			(5,899)
Operating lease liabilities				(23,066)
Accounts payable			(2,827,195)	128,263
Accrued expenses			342,868	2,786,497
Net cash used in operating activities			(32,299,606)	(17,015,864)
FINANCING ACTIVITIES
Proceeds from the sale of common stock and warrants to purchase common stock, net of issuance costs			56,141,000	24,297,734
Proceeds from debt				30,000,000
Payments of finance lease obligations			(4,267)	(5,686)
Repayment of debt				(10,220,000)
Payment of financing costs				(823,894)
Net cash provided by financing activities			56,136,733	43,248,154
Net increase in cash and cash equivalents			23,837,127	26,232,290
Cash and cash equivalents at beginning of period			23,391,982	17,396,812
Cash and cash equivalents at end of period	$ 47,229,109	$ 43,629,102	47,229,109	43,629,102
Supplemental disclosure of cash flow information:
Cash paid for interest			475,000	1,159,008
Supplemental schedule of non-cash financing activities:
Convertible promissory note converted into common stock			3,000,000
Recognition of warrant liability			89,510,165
Common stock issuance costs in accounts payable and accrued expenses			$ 642,689
Deferred offering costs amortization				$ 5,573

Common Stock and Stockholders' Equity

6 Months Ended

Mar. 31, 2024

Common Stock and Stockholders' Equity

Common Stock and Stockholders' Equity

9. Common Stock and Stockholders’ Equity

Common stock

On March 7, 2024, following receipt of stockholder approval at the Company’s 2024 annual meeting of stockholders, the number of authorized shares of common stock under the Company’s Certificate of Incorporation was increased from 21,250,000 shares to 60,000,000 shares.

On March 18, 2024, in a private placement (the “Private Placement”) pursuant to a securities purchase agreement entered in January 2024 with certain institutional and accredited investors, including GMS Ventures and Investments (“GMS Ventures”), the Company’s largest stockholder, the Company issued an aggregate of 8,571,423 shares of common stock and warrants to purchase an aggregate of 12,857,133 shares of common stock at a purchase price per share of $7.00 per share and accompanying warrant to purchase one and one-half shares of common stock for $55,498,311 in net proceeds after payment of placement agent fees and other offering costs. GMS Ventures purchased an aggregate of 2,305,714 shares of common stock and warrants to purchase an aggregate of 3,458,571 shares of common stock in the Private Placement. The Warrants have an exercise price of $7.70 per share of common stock and will expire on March 18, 2029.

The Company evaluated the equity classification for the common stock warrants and considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity (“ASC 815-40”). The Company determined that the warrants did not meet the “fixed for fixed” settlement provision set forth in Step 2 of the indexation guidance and as a result they are not indexed to the Company’s own stock and must be classified as liabilities. The warrants were measured at fair value at issuance and recorded as a liability and will be remeasured to fair value at each subsequent reporting date, with changes in fair value recorded in current earnings. The net proceeds from the Private Placement were allocated first to the warrants at fair value, with the residual amount recorded as common stock at par

value. The Company will continue to classify such warrants as liabilities until they are exercised, expire, or are no longer required to be classified as liabilities.

As the fair value of the warrants upon issuance was more than the proceeds of the Private Placement, there are no proceeds allocated to additional paid in capital. The excess fair value of the warrants over the net proceeds was $34,097,568 in the aggregate and was recorded as warrant related expenses in the unaudited interim consolidated statement of operations.

In December 2022, in a registered direct equity offering to certain institutional and accredited investors, including GMS Ventures, the Company issued 1,423,041 shares of common stock at a purchase price per share of $17.568 for $23,208,679 in net proceeds after payment of placement agent fees and other offering costs. GMS Ventures purchased an aggregate of 711,520 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 25,787 shares of common stock at an exercise price of $21.00 per share, which warrants have a three-year term.

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

On March 26, 2021, the Company entered into an At-the-Market Offering Agreement with H.C. Wainwright & Co., as sales agent (“Wainwright”) (the “Wainwright ATM Agreement” or the “Wainwright ATM Offering”), under which the Company could 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 reclassified to additional paid in capital on a pro rata basis when the Company sold common stock under the Wainwright ATM Offering.

Under the Wainwright ATM Agreement, the Company paid Wainwright a commission equal to 3.0% of the aggregate gross proceeds of any sales of common stock under the Wainwright ATM Agreement. The Company terminated the Wainwright ATM Agreement effective May 15, 2023. As a result, the Company wrote off unamortized deferred costs under the Wainwright ATM Agreement effective as of the termination date.

No shares of common stock were sold under the Wainwright ATM Offering during the three months ended March 31, 2023. During the six months ended March 31, 2023, the Company sold 44,769 shares of common stock under the Wainwright ATM Offering and generated $1,089,105 in net proceeds. The Company paid fees to Wainwright and other issuance costs of $38,799.

BTIG, LLC At-the-Market Offering Agreement

On May 16, 2023, the Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) as sales agent (as amended, the “BTIG ATM Agreement” or the “BTIG ATM Offering”), under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $100,000,000 from time to time through BTIG. The Company incurred financing costs of $353,688, 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 BTIG ATM Offering. As of March 31, 2024, $331,512 of such deferred costs are included in other assets on the unaudited interim consolidated balance sheets.

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

No shares of common stock were sold under the BTIG ATM Offering during the three and six months ended March 31, 2024.

Common stock warrants

As of March 31, 2024, 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)	13,850	$	240.00
February 24, 2025		8,642	$	25.40
April 13, 2025	(i)	7,284	$	240.00
May 31, 2025	(i)	3,121	$	240.00
June 22, 2025		9,563	$	30.38
December 28, 2025		25,787	$	21.00
January 28, 2026		12,576	$	25.00
February 2, 2026		93,238	$	25.00
November 23, 2026		104,999	$	31.25
March 18, 2029	(ii)	12,857,133	$	7.70
		13,136,193

(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 unaudited interim 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.

(ii)

The warrants were issued in connection with a private placement that closed on March 18, 2024 and are exercisable only for cash, except in limited circumstances, at any time after the date of issuance. The Company evaluated the warrants under ASC 815, Derivatives and Hedging, guidance and determined that the warrants did not meet Step 2 of the indexation, as a result they are not indexed to the Company’s own stock and must be classified as liabilities. Refer above for further details.

A holder of warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than a specified percentage of the outstanding common stock (4.99%, 9.99% or 19.99%, as applicable), immediately after giving effect to such exercise, which may be increased or decreased at the holders’ option (not to exceed 19.99%), effective 61 days after written notice to the Company. In addition, the Company may require the holders to cash exercise the warrants under certain circumstances as follows: (i) if the VWAP of the common stock equals or exceeds $1.00 per share (subject to adjustment in the event of stock splits, combinations or similar events, such as the reverse stock split implemented prior to Closing as discussed below) for 30 consecutive days (the “Stock Price Condition”) at any time after the Company publicly announces topline data from its NORSE EIGHT clinical trial evidencing satisfaction of the trial’s primary endpoints (the “NORSE EIGHT Announcement”), upon the consent of a majority of the members of the Company’s board of directors, the Company may require the holders to exercise up to 20% of the aggregate number of warrants issued to such holder on the issue date; and (ii) the Company may require up to the remainder of the warrants be exercised (A) if the Stock Price Condition is satisfied at any time after the Company publicly announces approval from the FDA of its BLA for ONS-5010, upon the consent of a majority of the members of the board of directors or (B) if the Stock Price Condition is satisfied at any time after the NORSE EIGHT Announcement, upon the unanimous consent of the members of the Company’s Board of Directors present at duly called meeting.

- Definition

The entire disclosure for equity.

+ References

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+ Details

Debt - Summary (Details) - USD ($)	Mar. 31, 2024	Sep. 30, 2023
Debt
Less: current portion	$ (44,745,000)	$ (35,551,000)
December 2022 Note
Debt
Total debt	$ 44,745,000	$ 35,551,000

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1E
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1E

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1F
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1F

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1F
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1F

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1F
-Subparagraph (b)(1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1F

Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1F
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1F

Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

+ Details

Fair Value Measurements

6 Months Ended

Mar. 31, 2024

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:


	March 31, 2024
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Unsecured convertible promissory note	$	—	$	—	$	44,745,000
Warrant liability		—		—		139,184,543
Total	$	—	$	—	$	183,929,543

	September 30, 2023
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Unsecured convertible promissory note	$	—	$	—	$	35,551,000
Warrant liability		—		—		6,219
Total	$	—	$	—	$	35,557,219

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 six months ended March 31, 2024:


	Unsecured Convertible
	Promissory Note		Warrants
Balance at October 1, 2023	$	35,551,000	$	6,219
Issued in connection with sale of common stock		—		89,510,165
Promissory note maturity extension fee added to outstanding balance		2,681,847		—
Principal and accrued interest converted to common stock		(3,000,000)		—
Change in fair value		9,512,153		49,668,159
Balance at March 31, 2024	$	44,745,000	$	139,184,543

As further described in Note 7, the Company elected the fair value option to account for an unsecured convertible promissory note issued in December 2022 (the “December 2022 Note”). The fair value of the December 2022 Note is estimated using a binomial lattice model, which evaluates the payouts under hold, convert or call decisions. Significant estimates in the binomial lattice model include the Company’s stock price, volatility, risk-free rate of return, and credit-adjusted discount rate.

The fair value of the December 2022 Note was estimated using a binomial lattice model with the following assumptions:


	March 31, 2024			September 30, 2023
Term (years)		1.3			0.3
Stock price	$	11.94		$	4.40
Volatility		167.0	%		71.0	%
Risk-free rate		4.9	%		5.5	%
Dividend yield		—	%		—	%
Credit-adjusted discount rate		21.7	%		22.8	%

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 and warrants issued in connection with a private placement that closed on March 18, 2024 are classified as liabilities on the accompanying unaudited interim consolidated balance sheets. The warrants related to the Note and Warrant Purchase Agreement dated December 22, 2017 are classified as liabilities as the warrants include cash settlement features at the option of the holders under certain circumstances. The warrants issued in connection with a private placement that closed on March 18, 2024 are classified as liabilities as the Company assessed that they are not indexed to the Company’s own stock and must be classified as liabilities. For further details on the evaluation refer to Note 9.

The above warrant liabilities are revalued each reporting period with the change in fair values recorded in the accompanying consolidated statements of operations until the warrants are exercised or expire. The fair values of the warrant liabilities are estimated using the Black-Scholes option pricing model using the following weighted average assumptions:


	March 31, 2024			September 30, 2023
Risk-free interest rate		4.21	%		5.30	%
Remaining contractual term of warrants (years)		5.0			1.4
Expected volatility		135.4	%		158.3	%
Annual dividend yield		—	%		—	%
Fair value of common stock (per share)	$	11.94		$	4.40

- 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

Common Stock and Stockholders' Equity - Common Stock (Details) - USD ($)					1 Months Ended	3 Months Ended		6 Months Ended
	Apr. 15, 2024	Mar. 18, 2024	May 16, 2023	Mar. 26, 2021	Dec. 31, 2022	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Mar. 31, 2023	Mar. 07, 2024	Mar. 06, 2024	Sep. 30, 2023
Common Stock and Stockholders' Equity
Common stock, shares authorized						60,000,000		60,000,000		60,000,000	21,250,000	60,000,000
Common stock issued (in shares)	714,286
Common stock issuable on exercise of warrants (in shares)	1,071,429					13,136,193		13,136,193
Proceeds from issuance of stock	$ 5,000,000							$ 56,141,000	$ 24,297,734
Exercise price per share	$ 7.70
Warrants related expenses		$ 34,097,568				$ 34,097,568		$ 34,097,568
Private placement
Common Stock and Stockholders' Equity
Common stock issued (in shares)		8,571,423
Common stock issuable on exercise of warrants (in shares)		12,857,133
Shares issued price (in dollars per share)		$ 7.00
Common stock issuable by each warrants (in shares)		1.5
Proceeds from issuance of stock		$ 55,498,311
Private placement \| GMS Ventures & Investments
Common Stock and Stockholders' Equity
Common stock issued (in shares)		2,305,714
Common stock issuable on exercise of warrants (in shares)		3,458,571
Exercise price per share		$ 7.70
Direct registered offering
Common Stock and Stockholders' Equity
Common stock issued (in shares)					1,423,041
Shares issued price (in dollars per share)					$ 17.568
Proceeds from issuance of stock					$ 23,208,679
Direct registered offering \| GMS Ventures & Investments
Common Stock and Stockholders' Equity
Common stock issued (in shares)					711,520
Underwriter
Common Stock and Stockholders' Equity
Common stock issuable on exercise of warrants (in shares)					25,787
Exercise price per share					$ 21.00
Warrants exercise term					3 years
Wainwright ATM offering
Common Stock and Stockholders' Equity
Common stock issued (in shares)							0		44,769
Proceeds from issuance of stock									$ 1,089,105
Aggregate maximum offering price				$ 40,000,000
Amount reclassified on additional paid in capital				$ 197,654
Payment of fees to sales agent									$ 38,799
Common stock sale commission (as a percent)				3.00%
BTIG ATM
Common Stock and Stockholders' Equity
Common stock issued (in shares)						0		0
Aggregate maximum offering price			$ 100,000,000
Amount reclassified on additional paid in capital			$ 353,688
Deferred costs						$ 331,512		$ 331,512
Common stock sale commission (as a percent)								3.00%

Stock-Based Compensation - Non-options (Details) - Performance-based stock units	6 Months Ended
	Mar. 31, 2024 $ / shares shares
Share-based Compensation
Term of award	10 years
Number of PSUs
Balance, Beginning	123
Forfeitures
Balance, Ending	123
Vested and exercisable	123
Vested and expected to vest	123
Weighted Average Base Price Per Unit
Balance, Beginning \| $ / shares	$ 999.40
Forfeitures \| $ / shares
Balance, Ending \| $ / shares	999.40
Vested and exercisable \| $ / shares	$ 999.40
Vested and expected to vest	999.40%
Weighted average remaining contractual term, Outstanding	3 months 18 days
Weighted average remaining contractual term, Vested and exercisable	3 months 18 days
Weighted average remaining contractual term, Vested and expected to vest	3 months 18 days

Common Stock and Stockholders' Equity (Tables)

6 Months Ended

Mar. 31, 2024

Common Stock and Stockholders' Equity

Schedule of warrants outstanding

As of March 31, 2024, 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)	13,850	$	240.00
February 24, 2025		8,642	$	25.40
April 13, 2025	(i)	7,284	$	240.00
May 31, 2025	(i)	3,121	$	240.00
June 22, 2025		9,563	$	30.38
December 28, 2025		25,787	$	21.00
January 28, 2026		12,576	$	25.00
February 2, 2026		93,238	$	25.00
November 23, 2026		104,999	$	31.25
March 18, 2029	(ii)	12,857,133	$	7.70
		13,136,193

(i)

(ii)

Accrued Expenses (Tables)

6 Months Ended

Mar. 31, 2024

Accrued Expenses

Schedule of accrued expenses


	March 31, 2024		September 30, 2023
Compensation	$	1,139,963	$	919,970
Professional fees		1,215,594		165,192
Research and development		544,562		1,234,192
Other accrued expenses		215,271		426,386
	$	3,115,390	$	2,745,740

Accrued Expenses (Details) - USD ($)	Mar. 31, 2024	Sep. 30, 2023
Accrued Expenses
Compensation	$ 1,139,963	$ 919,970
Professional fees	1,215,594	165,192
Research and development	544,562	1,234,192
Other accrued expenses	215,271	426,386
Accrued expenses, total	$ 3,115,390	$ 2,745,740

Accrued Expenses

6 Months Ended

Mar. 31, 2024

Accrued Expenses

Accrued Expenses

6. Accrued Expenses

Accrued expenses consists of:


	March 31, 2024		September 30, 2023
Compensation	$	1,139,963	$	919,970
Professional fees		1,215,594		165,192
Research and development		544,562		1,234,192
Other accrued expenses		215,271		426,386
	$	3,115,390	$	2,745,740

Stock-Based Compensation - Stock option activity (Details) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Mar. 31, 2023
Weighted Average Remaining Contractual Term (Years)
Stock-based compensation expense	$ 1,310,507	$ 1,383,405	$ 2,583,118	$ 2,775,798
Employee Stock Option [Member]
Number of Shares
Balance, Beginning (in shares)			1,197,774
Granted (in shares)			799,729
Forfeited (in shares)			29,605
Expired (in shares)			8,333
Balance, Ending (in shares)	1,959,565		1,959,565
Exercisable (in shares)	875,865		875,865
Vested and expected to vest (in shares)	1,959,565		1,959,565
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)			$ 28.72
Granted (in dollars per share)			6.70
Forfeited (in dollars per share)			27.93
Expired (in dollars per share)			33.60
Balance, Ending (in dollars per share)	$ 19.72		19.72
Exercisable (in dollars per share)	27.62		27.62
Vested and expected to vest (in dollars per share)	$ 19.72		$ 19.72
Weighted Average Remaining Contractual Term (Years)
Balance-Remaining contractual term			8 years 2 months 12 days
Vested and exercisable -Remaining contractual term			7 years
Vested and expected to vest-Remaining contractual term			8 years 2 months 12 days
Aggregate intrinsic value, Outstanding	$ 4,219,550		$ 4,219,550
Aggregate intrinsic value, Vested and exercisable	383,313		383,313
Aggregate intrinsic value, Vested and expected to vest	$ 4,219,550		$ 4,219,550
Grant date fair value of options (in dollars per share)			$ 6.06	$ 19.20
Performance-based stock options
Number of Shares
Balance, Beginning (in shares)			35,000
Granted (in shares)			634,000
Balance, Ending (in shares)	669,000		669,000
Vested and exercisable (in shares)	35,000		35,000
Vested and expected to vest (in shares)	669,000		669,000
Weighted Average Exercise Price
Balance, Beginning (in dollars per share)			$ 28.80
Granted (in dollars per share)			6.78
Balance, Ending (in dollars per share)	$ 7.93		7.93
Vested and exercisable (in dollars per share)	28.80		28.80
Vested and expected to vest (in dollars per share)	$ 7.93		$ 7.93
Weighted Average Remaining Contractual Term (Years)
Balance-Remaining contractual term			9 years 10 months 24 days
Vested and exercisable -Remaining contractual term			7 years 8 months 12 days
Vested and expected to vest-Remaining contractual term			9 years 10 months 24 days
Aggregate intrinsic value, Outstanding	$ 3,271,440		$ 3,271,440
Aggregate intrinsic value, Vested and expected to vest	$ 3,271,440		$ 3,271,440
Term of award			10 years
Grant date fair value of options (in dollars per share)				$ 6.52

Consolidated Statements of Operations (unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Mar. 31, 2023
Operating expenses:
Research and development	$ 13,508,934	$ 544,948	$ 18,038,292	$ 10,407,372
General and administrative	5,431,041	6,292,982	11,224,805	12,118,586
Total Operating expenses	18,939,975	6,837,930	29,263,097	22,525,958
Loss from operations	(18,939,975)	(6,837,930)	(29,263,097)	(22,525,958)
Loss (income) on equity method investment	30,595	16,965	28,047	(4,540)
Interest expense (income), net	3,084,035	(187,794)	2,895,358	2,260,797
Loss on extinguishment of debt				577,659
Change in fair value of promissory notes	8,519,153	3,000	9,512,153	3,000
Warrants related expenses (Note 9)	34,097,568		34,097,568
Change in fair value of warrant liability	49,614,817	(18,615)	49,668,159	(48,875)
Loss before income taxes	(114,286,143)	(6,651,486)	(125,464,382)	(25,313,999)
Income tax expense	2,800	2,800	2,800	2,800
Net loss	$ (114,288,943)	$ (6,654,286)	$ (125,467,182)	$ (25,316,799)
Per share information:
Net loss per share of common stock, basic (in dollars per share)	$ (8.01)	$ (0.52)	$ (9.20)	$ (2.09)
Net loss per share of common stock, diluted (in dollars per share)	$ (8.01)	$ (0.52)	$ (9.20)	$ (2.09)
Weighted average shares outstanding, basic (in shares)	14,270,289	12,833,330	13,638,126	12,093,889
Weighted average shares outstanding, diluted (in shares)	14,270,289	12,833,330	13,638,126	12,093,889

Commitments and Contingencies (Tables)

6 Months Ended

Mar. 31, 2024

Commitments and Contingencies

Schedule of lease information

The components of lease cost for the three and six months ended March 31, 2024 and 2023 are as follows:


	Three months ended March 31,				Six months ended March 31,
	2024		2023		2024		2023
Lease cost:
Amortization of right-of-use assets	$	—	$	—	$	—	$	—
Interest on lease liabilities		12		398		116		889
Total finance lease cost		12		398		116		889
Operating lease cost		11,217		11,216		22,433		22,433
Total lease cost	$	11,229	$	11,614	$	22,549	$	23,322

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


	March 31, 2024		September 30, 2023
Operating leases:
Right-of-use asset	$	3,739	$	26,172
Operating lease liabilities		—		—
Finance leases:
Right-of-use asset	$	—	$	—
Financing lease liabilities		—		4,267
Weighted-average remaining lease term (years):
Operating leases		0.1		0.6
Finance leases		—		0.3
Weighted-average discount rate:
Operating leases		7.5%		7.5%
Finance leases		—		13.0%

Other information related to leases for the six months ended March 31, 2024 and 2023 are as follows:


	Six months ended March 31,
	2024		2023
Cash paid for amounts included in the measurement of lease obligations:
Operating cash flows from finance leases	$	116	$	889
Operating cash flows from operating leases		—		23,721
Financing cash flows from finance leases		4,267		5,686

Fair Value Measurements (Tables)

6 Months Ended

Mar. 31, 2024

Fair value

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


	March 31, 2024
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Unsecured convertible promissory note	$	—	$	—	$	44,745,000
Warrant liability		—		—		139,184,543
Total	$	—	$	—	$	183,929,543

	September 30, 2023
	(Level 1)		(Level 2)		(Level 3)
Liabilities
Unsecured convertible promissory note	$	—	$	—	$	35,551,000
Warrant liability		—		—		6,219
Total	$	—	$	—	$	35,557,219

Schedule of changes in the fair value of Level 3 liabilities


	Unsecured Convertible
	Promissory Note		Warrants
Balance at October 1, 2023	$	35,551,000	$	6,219
Issued in connection with sale of common stock		—		89,510,165
Promissory note maturity extension fee added to outstanding balance		2,681,847		—
Principal and accrued interest converted to common stock		(3,000,000)		—
Change in fair value		9,512,153		49,668,159
Balance at March 31, 2024	$	44,745,000	$	139,184,543

December 2022 Note

Fair value

Schedule of fair value inputs


	March 31, 2024			September 30, 2023
Term (years)		1.3			0.3
Stock price	$	11.94		$	4.40
Volatility		167.0	%		71.0	%
Risk-free rate		4.9	%		5.5	%
Dividend yield		—	%		—	%
Credit-adjusted discount rate		21.7	%		22.8	%

Warrant liability

Fair value

Schedule of fair value inputs


	March 31, 2024			September 30, 2023
Risk-free interest rate		4.21	%		5.30	%
Remaining contractual term of warrants (years)		5.0			1.4
Expected volatility		135.4	%		158.3	%
Annual dividend yield		—	%		—	%
Fair value of common stock (per share)	$	11.94		$	4.40

Stock-Based Compensation - Information (Details)	6 Months Ended
Stock-Based Compensation - Information (Details)	Mar. 31, 2024 shares
Performance-based stock units
Share-based Compensation
Term of award	10 years
2011 Equity Incentive Plan \| Performance-based stock units
Share-based Compensation
Awards outstanding	123
2015 Equity Incentive Plan
Share-based Compensation
Aggregate number of common stock authorized for issuance	2,503,677
Number of shares available for grant	0
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

Commitments and Contingencies - Lease cost (Details) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2021
Leases
Operating lease term for lease not yet commenced	5 years		5 years
Finance lease term					3 years
Lease cost
Interest on lease liabilities	$ 12	$ 398	$ 116	$ 889
Total finance lease cost	12	398	116	889
Operating lease cost	11,217	11,216	22,433	22,433
Total lease cost	$ 11,229	$ 11,614	$ 22,549	$ 23,322
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%

Equity Method Investment

6 Months Ended

Mar. 31, 2024

Equity Method Investment

Equity Method Investment

5. Equity Method Investment

In connection with the execution of a stock purchase agreement with Syntone Ventures LLC, 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 JV”), 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 JV’s operations through voting rights or representation on Syntone JV’s board of directors, the Company accounts for this investment using the equity method of accounting. Upon formation of Syntone JV in April 2021, the Company entered into a royalty-free license with Syntone JV 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 is committed to making capital contributions to Syntone JV of approximately $2,100,000, based upon the development plan contemplated in the license agreement. The maximum exposure to a loss as a result of the Company’s involvement in Syntone JV is limited to the initial investment and the future capital contributions totaling approximately $2,100,000.

Fair Value Measurements (Details) - USD ($)	Mar. 31, 2024	Sep. 30, 2023
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	$ 44,745,000	$ 35,551,000
Warrant liability	139,184,543	6,219
Total	$ 183,929,543	$ 35,557,219

- Definition

Fair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

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

6 Months Ended

Mar. 31, 2024

Basis of Presentation and Summary of Significant Accounting Policies

Basis of presentation

Reverse stock-split

Use of estimates

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

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


		Three months ended March 31,			Six months ended March 31,
	2024		2023		2024		2023
Net loss attributable to common stockholders	$	(114,288,943)	$	(6,654,286)	$	(125,467,182)	$	(25,316,799)
Common stock shares outstanding (weighted average)		14,270,289		12,833,330		13,638,126		12,093,889
Basic and diluted net loss per share	$	(8.01)	$	(0.52)	$	(9.20)	$	(2.09)


	As of March 31,
	2024		2023
Performance-based stock units	123		123
Performance-based stock options	669,000		95,000
Stock options	1,959,565		1,103,242
Common stock warrants	13,136,193		366,410
Convertible debt	2,304,391	⁽ⁱ⁾	815,262	⁽ⁱⁱ⁾

(i)

(ii)

The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7.

Recently issued accounting pronouncements

Consolidated Balance Sheets (unaudited) - USD ($)	Mar. 31, 2024	Sep. 30, 2023
Current assets:
Cash and cash equivalents	$ 47,229,109	$ 23,391,982
Prepaid expenses and other current assets	10,556,696	7,587,216
Total current assets	57,785,805	30,979,198
Operating lease right-of-use assets, net	3,739	26,172
Equity method investment	765,885	793,932
Other assets	473,241	501,299
Total assets	59,028,670	32,300,601
Current liabilities:
Unsecured convertible promissory note	44,745,000	35,551,000
Finance lease liabilities		4,267
Accounts payable	4,363,235	6,574,523
Accrued expenses	3,115,390	2,745,740
Income taxes payable	1,856,629	1,856,629
Total current liabilities	54,080,254	46,732,159
Warrant liability	139,184,543	6,219
Total liabilities	193,264,797	46,738,378
Commitments and contingencies (Note 8)
Convertible preferred stock:
Total convertible preferred stock
Stockholders' deficit:
Preferred stock, value
Common stock, par value $0.01 per share; 60,000,000 shares authorized; 22,012,827 and 13,012,833 shares issued and outstanding at March 31, 2024 and September 30, 2023, respectively	220,128	130,128
Additional paid-in capital	458,929,113	453,350,281
Accumulated deficit	(593,385,368)	(467,918,186)
Total stockholders' deficit	(134,236,127)	(14,437,777)
Total liabilities, convertible preferred stock and stockholders' deficit	59,028,670	32,300,601
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' deficit:
Preferred stock, value

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

6 Months Ended

Mar. 31, 2024

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,
	2024		2023		2024		2023
Net loss attributable to common stockholders	$	(114,288,943)	$	(6,654,286)	$	(125,467,182)	$	(25,316,799)
Common stock shares outstanding (weighted average)		14,270,289		12,833,330		13,638,126		12,093,889
Basic and diluted net loss per share	$	(8.01)	$	(0.52)	$	(9.20)	$	(2.09)

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


	As of March 31,
	2024		2023
Performance-based stock units	123		123
Performance-based stock options	669,000		95,000
Stock options	1,959,565		1,103,242
Common stock warrants	13,136,193		366,410
Convertible debt	2,304,391	⁽ⁱ⁾	815,262	⁽ⁱⁱ⁾

(i)

(ii)

The potentially dilutive securities related to convertible debt are calculated based on a fixed conversion price of $40.00 per share, which is subject to change as described in Note 7.

Consolidated Statements of Stockholders (Deficit) Equity (unaudited) - USD ($)	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Sep. 30, 2022	$ 113,655	$ 417,558,434	$ (408,935,518)	$ 8,736,571
Balance, beginning (in shares) at Sep. 30, 2022	11,365,528
Increase (Decrease) in Stockholders' Equity
Sale of common stock, net of issuance costs	$ 14,678	24,277,482		24,292,160
Sale of common stock, net of issuance costs (in shares)	1,467,802
Stock-based compensation expense		1,392,393		1,392,393
Net loss			(18,662,513)	(18,662,513)
Balance at Dec. 31, 2022	$ 128,333	443,228,309	(427,598,031)	15,758,611
Balance, ending (in shares) at Dec. 31, 2022	12,833,330
Balance at Sep. 30, 2022	$ 113,655	417,558,434	(408,935,518)	8,736,571
Balance, beginning (in shares) at Sep. 30, 2022	11,365,528
Increase (Decrease) in Stockholders' Equity
Net loss				(25,316,799)
Balance at Mar. 31, 2023	$ 128,333	444,611,714	(434,252,317)	10,487,730
Balance, ending (in shares) at Mar. 31, 2023	12,833,330
Balance at Dec. 31, 2022	$ 128,333	443,228,309	(427,598,031)	15,758,611
Balance, beginning (in shares) at Dec. 31, 2022	12,833,330
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense		1,383,405		1,383,405
Net loss			(6,654,286)	(6,654,286)
Balance at Mar. 31, 2023	$ 128,333	444,611,714	(434,252,317)	10,487,730
Balance, ending (in shares) at Mar. 31, 2023	12,833,330
Balance at Sep. 30, 2023	$ 130,128	453,350,281	(467,918,186)	(14,437,777)
Balance, beginning (in shares) at Sep. 30, 2023	13,012,833
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense		1,272,611		1,272,611
Net loss			(11,178,239)	(11,178,239)
Balance at Dec. 31, 2023	$ 130,128	454,622,892	(479,096,425)	(24,343,405)
Balance, ending (in shares) at Dec. 31, 2023	13,012,833
Balance at Sep. 30, 2023	$ 130,128	453,350,281	(467,918,186)	(14,437,777)
Balance, beginning (in shares) at Sep. 30, 2023	13,012,833
Increase (Decrease) in Stockholders' Equity
Net loss				(125,467,182)
Balance at Mar. 31, 2024	$ 220,128	458,929,113	(593,385,368)	(134,236,127)
Balance, ending (in shares) at Mar. 31, 2024	22,012,827
Balance at Dec. 31, 2023	$ 130,128	454,622,892	(479,096,425)	(24,343,405)
Balance, beginning (in shares) at Dec. 31, 2023	13,012,833
Increase (Decrease) in Stockholders' Equity
Issuance of common stock in connection with conversion of convertible promissory note	$ 4,286	2,995,714		3,000,000
Issuance of common stock in connection with conversion of convertible promissory note (in shares)	428,571
Sale of common stock, net of issuance costs	$ 85,714			85,714
Sale of common stock, net of issuance costs (in shares)	8,571,423
Stock-based compensation expense		1,310,507		1,310,507
Net loss			(114,288,943)	(114,288,943)
Balance at Mar. 31, 2024	$ 220,128	$ 458,929,113	$ (593,385,368)	$ (134,236,127)
Balance, ending (in shares) at Mar. 31, 2024	22,012,827

- Definition

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

+ References

+ Details

- Definition

Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering.

+ References + Details

- Definition

Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest.

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+ Details

Document And Entity Information - shares	6 Months Ended
Document And Entity Information - shares	Mar. 31, 2024	May 13, 2024
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
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	111 S. Wood Avenue, Unit #100
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		23,405,637
Entity Central Index Key	0001649989
Current Fiscal Year End Date	--09-30
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q2
Amendment Flag	false

Subsequent Events (Details) - USD ($)	1 Months Ended		6 Months Ended
Subsequent Events (Details) - USD ($)	May 31, 2024	Apr. 30, 2024	Mar. 31, 2024
Subsequent Events
Carrying value of notes exchanged			$ 3,000,000
December 2022 Note
Subsequent Events
Carrying value of notes exchanged			$ 3,000,000
Shares converted			428,571
Subsequent Events \| December 2022 Note
Subsequent Events
Carrying value of notes exchanged	$ 4,750,000	$ 4,750,000
Shares converted	678,570	678,570

Basis of Presentation and Summary of Significant Accounting Policies - EPS (Details)		3 Months Ended		6 Months Ended
	Mar. 14, 2024	Mar. 31, 2024 USD ($) $ / shares shares	Mar. 31, 2023 USD ($) $ / shares shares	Mar. 31, 2024 USD ($) $ / shares shares	Mar. 31, 2023 USD ($) $ / shares shares
Basic and diluted earnings per share:
Net loss attributable to common stockholders \| $		$ (114,288,943)	$ (6,654,286)	$ (125,467,182)	$ (25,316,799)
Basic Earnings Per Share
Common stock shares outstanding (weighted average), basic (in shares) \| shares		14,270,289	12,833,330	13,638,126	12,093,889
Basic net loss per share (in dollars per share) \| $ / shares		$ (8.01)	$ (0.52)	$ (9.20)	$ (2.09)
Diluted Earnings Per Share
Common stock shares outstanding (weighted average), diluted (in shares) \| shares		14,270,289	12,833,330	13,638,126	12,093,889
Diluted net loss per share (in dollars per share) \| $ / shares		$ (8.01)	$ (0.52)	$ (9.20)	$ (2.09)
Conversion ratio	0.05

- 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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+ Details

Related-Party Transactions (Details) - USD ($)			3 Months Ended		6 Months Ended
Related-Party Transactions (Details) - USD ($)	Apr. 15, 2024	Dec. 21, 2021	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Mar. 31, 2023	Sep. 30, 2023
Related party
Common stock issued (in shares)	714,286
Research and development			$ 13,508,934	$ 544,948	$ 18,038,292	$ 10,407,372
Accounts payable			4,363,235		4,363,235		$ 6,574,523
General and administrative			5,431,041	6,292,982	11,224,805	12,118,586
Accrued expenses			3,115,390		$ 3,115,390		2,745,740
Employee Stock Option [Member]
Related party
Number of options granted					799,729
Performance-based stock options
Related party
Number of options granted					634,000
Related Party \| Employee Stock Option [Member]
Related party
Vesting (as a percent)		25.00%
Vesting period		3 years
Related Party \| Performance-based stock options
Related party
Number of stock options vested					200,000
Related Party \| MTTR
Related party
Research and development			60,000	$ 28,886	$ 120,000	$ 65,552
Accounts payable			$ 0		$ 0		$ 0
Related Party \| Terry Dagnon
Related party
Base salary		$ 450,000
Percentage of cash bonus		50.00%
Related Party \| Terry Dagnon \| Employee Stock Option [Member]
Related party
Number of options granted		800,000
Related Party \| Terry Dagnon \| Performance-based stock options
Related party
Number of options granted		200,000
Related Party \| Jeff Evanson
Related party
Base salary		$ 450,000
Percentage of cash bonus		50.00%
Related Party \| Jeff Evanson \| Employee Stock Option [Member]
Related party
Number of options granted		800,000
Related Party \| Jeff Evanson \| Performance-based stock options
Related party
Number of options granted		200,000

Subsequent Events

6 Months Ended

Mar. 31, 2024

Subsequent Events

Subsequent Events

12. Subsequent Events

Unsecured convertible promissory note conversions

In April and May 2024, an aggregate of principal and accrued interest totaling $4,750,000 of the December 2022 Note was converted into 678,570 shares of the Company’s common stock. For further details on the December 2022 Note, refer to Note 7.

Restated Certificate of Incorporation

On May 13, 2024, the Company filed a Certificate of Elimination to its Certificate of Incorporation, as then amended, with the Secretary of State of the State of Delaware to eliminate from the Certificate of Incorporation all matters set forth in the Certificates of Designation filed with the Secretary of State of the State of Delaware on September 8, 2017 (with respect to its Series A Convertible Preferred Stock and the Series B Convertible Preferred Stock) and July 18, 2018, as amended on March 19, 2020 (with respect to its Series A-1 Convertible Preferred Stock) and returning each of the Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series A-1 Convertible Preferred Stock to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series. There were no outstanding shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock or Series A-1 Convertible Preferred Stock as of May 13, 2024. Immediately following the filing of the Certificate of Elimination, the Company filed a Restated Certificate of Incorporation of the Company with the Secretary of State of the State of Delaware, which restates and integrates but does not further amend the Company’s Certificate of Incorporation, as then amended.

Debt (Tables)

6 Months Ended

Mar. 31, 2024

Debt

Schedule of debt


	March 31, 2024		September 30, 2023
Unsecured convertible promissory note (measured at fair value)	$	44,745,000	$	35,551,000
Less: current portion		(44,745,000)		(35,551,000)
Long-term debt	$	—	$	—

- 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

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
Syntone PRC
Investments
Ownership percentage	80.00%

Liquidity (Details) - USD ($)			3 Months Ended	6 Months Ended
Liquidity (Details) - USD ($)	Apr. 15, 2024	Mar. 18, 2024	Mar. 31, 2024	Mar. 31, 2024	Mar. 31, 2023	Sep. 30, 2023	May 16, 2023
Accumulated deficit			$ 593,385,368	$ 593,385,368		$ 467,918,186
Common stock issued (in shares)	714,286
Proceeds from issuance of stock	$ 5,000,000			$ 56,141,000	$ 24,297,734
Common stock issuable on exercise of warrants (in shares)	1,071,429		13,136,193	13,136,193
Exercise price per share	$ 7.70
BTIG ATM
Common stock issued (in shares)			0	0
Aggregate maximum offering price							$ 100,000,000
Private placement
Common stock issued (in shares)		8,571,423
Proceeds from issuance of stock		$ 55,498,311
Common stock issuable on exercise of warrants (in shares)		12,857,133
Common stock issuable by each warrants (in shares)		1.5

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Related-Party Transactions

6 Months Ended

Mar. 31, 2024

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 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.

Mr. Dagnon transitioned from Chief Operations Officer to Senior Advisor on December 6, 2023, as part of the Company's strategic organizational realignment program.

During the three months ended March 31, 2024 and 2023, MTTR and its four principals under the strategic partnership agreement and the subsequent individual consulting agreements earned an aggregate of $60,000 and $28,886, respectively, and $120,000 and $65,552 during the six months ended March 31, 2024 and 2023, respectively, which includes monthly consulting fees and expense reimbursement. There were no amounts payable to the former MTTR principals at March 31, 2024 and September 30, 2023.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

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-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-07(2)(g)(3))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483575/946-220-S99-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-07(2)(c))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483575/946-220-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-07(2)(e))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483575/946-220-S99-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//850/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483326/850-10-50-6

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483326/850-10-50-1

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483326/850-10-50-1

+ Details

Debt - Information (Details)				1 Months Ended	3 Months Ended		6 Months Ended
Debt - Information (Details)	Jan. 22, 2024 USD ($) $ / shares	Dec. 22, 2022 USD ($) D $ / shares	Nov. 16, 2021 USD ($)	Dec. 31, 2023 USD ($)	Mar. 31, 2024 USD ($)	Mar. 31, 2023 USD ($)	Mar. 31, 2024 USD ($) shares	Mar. 31, 2023 USD ($)
Debt
Proceeds from loan								$ 30,000,000
Payment of lender fees								823,894
Carrying value of notes exchanged							$ 3,000,000
Interest paid								1,158,609
Gain (loss) on extinguishment of debt								(577,659)
December 2022 Note
Debt
Original principal amount		$ 31,820,000
Debt issuance costs		1,820,000		$ 475,000
Proceeds from loan		$ 18,052,461
Interest rate (as a percent)		9.50%
Trading day threshold \| D		30
Percentage of additional fee on payments in cash		7.50%
Percentage of increase in debt balance by lender for a Major Trigger Event		10.00%
Percentage of increase in debt balance by lender for a Minor Trigger Event		5.00%
Threshold trading days of written notice from Lender for cure of Trigger Event		10 days
Interest rate for the immediately due and payable amounts		22.00%
Conversion rate per share \| $ / shares	$ 7.00	$ 50.00
Conversion price required to satisfy conversion notice from the lender in cash \| $ / shares		$ 3.51
Percentage of participation right to Lender in future debt or equity financing		10.00%
Interest expense					$ 3,156,847		$ 3,156,847	2,074,964
Shares converted \| shares							428,571
Extension Fees	$ 2,681,847
Extension fee as percentage of the outstanding balance	7.50%
Aggregate principal amount on which initial conversion price is reduced	$ 15,000,000
Quarterly payment	$ 3,000,000
Payment of lender fees								254,964
Carrying value of notes exchanged							$ 3,000,000
December 2022 Note \| Prime rate
Debt
Spread on variable rate	3.00%
Floor interest rate	9.50%
December 2022 Note \| Major Trigger Event
Debt
Trading day threshold \| D		3
Conversion rate per share \| $ / shares		$ 40.00
Threshold percentage of stock price trigger		90.00%
November 2021 Note
Debt
Original principal amount			$ 10,220,000
Proceeds from loan			$ 10,000,000
Interest rate (as a percent)			9.50%
Interest expense					$ 0	$ 418,388	$ 0	454,866
Unamortized discount			$ 820,000
Redemption price (as a percent)		105.00%	105.00%
Repayments of unsecured debt		$ 11,947,539
Interest paid		1,158,609
Gain (loss) on extinguishment of debt		(577,659)
Amortization of debt issuance costs		8,729				$ 169,857		$ 190,775
Prepayment fee		$ 568,930

Consolidated Balance Sheets (unaudited) (Parentheticals) - $ / shares	Mar. 31, 2024	Sep. 30, 2023
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	60,000,000	60,000,000
Common stock, shares issued	22,012,827	13,012,833
Common stock, shares outstanding	22,012,827	13,012,833
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
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

Organization and Description of Business

6 Months Ended

Mar. 31, 2024

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.

In the fourth quarter of calendar 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial following discussions with the U.S. Food and Drug Administration (“FDA”) in support of the Company’s Biologics License Application (“BLA”) for ONS-5010. In December 2023, the Company submitted a Special Protocol Assessment (“SPA”) to the FDA for this study (NORSE EIGHT) seeking confirmation that, if successful, it will address the FDA’s requirement for a second adequate and well-controlled clinical trial to support its planned resubmission of the ONS-5010 BLA. In January 2024, the Company received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA and that, if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter (“CRL”). The first subject was enrolled in NORSE EIGHT in January 2024. In addition, through a Type A meeting and additional interactions, the Company has identified the approaches needed to resolve the chemistry, manufacturing and controls (“CMC”) comments in the CRL.

Separately, in October 2022 the Company submitted a Marketing Authorization Application (“MAA”), for ONS-5010 with the European Medicines Agency (“EMA”). On December 22, 2022, the Company’s MAA was validated for review by the EMA. In March 2024, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) was completed with a positive opinion issued on March 22, 2024. A related positive decision by the European Commission is estimated to be received in the second quarter of calendar 2024. ONS-5010 is the Company’s sole product candidate in active development.

Stock-Based Compensation

6 Months Ended

Mar. 31, 2024

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 March 31, 2024, PSUs representing 123 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 2,503,677. As of March 31, 2024, there were no shares 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 unaudited interim consolidated statements of operations for the three and six months ended March 31, 2024 and 2023:


	Three months ended March 31,				Six months ended March 31,
	2024		2023		2024		2023
Research and development	$	236,960	$	322,268	$	468,376	$	612,924
General and administrative		1,073,547		1,061,137		2,114,742		2,162,874
	$	1,310,507	$	1,383,405	$	2,583,118	$	2,775,798

Stock options

As of March 31, 2024, 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, 2023	1,197,774	$	28.72
Granted	799,729		6.70
Forfeited	(29,605)		27.93
Expired	(8,333)		33.60
Balance at March 31, 2024	1,959,565	$	19.72	8.2	$	4,219,550
Exercisable at March 31, 2024	875,865	$	27.62	7.0	$	383,313
Vested and expected to vest at March 31, 2024	1,959,565	$	19.72	8.2	$	4,219,550

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, 2024 and 2023 was $6.06 and $19.20 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,
	2024		2023
Risk-free interest rate	4.3	%	3.7	%
Expected term (years)	6.0		5.7
Expected volatility	131.3	%	112.4	%
Expected dividend yield	—		—

As of March 31, 2024, there was $10,784,269 of unrecognized compensation expense that is expected to be recognized over a weighted-average period of 1.6 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 March 31, 2024 and changes during the six 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, 2023	35,000	$	28.80
Granted	634,000		6.78
Balance at March 31, 2024	669,000	$	7.93	9.9	$	3,271,440
Exercisable at March 31, 2024	35,000	$	28.80	7.7	$	—
Vested and expected to vest at March 31, 2024	669,000	$	7.93	9.9	$	3,271,440

The vesting of the performance-based stock options is conditional upon FDA approval of ONS-5010. The expense for the performance-based stock options is not recognized until the performance conditions are deemed probable of achievement. The Company did not record any expense related to the performance-based stock options during the three and six months ended March 31, 2024 as the performance conditions were not deemed probable of being met. The weighted average grant date fair value of the performance stock options awarded during the six months ended March 31, 2024, was $6.52 per option. As of March 31, 2024, 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:


	Six months ended March 31,
	2024		2023
Risk-free interest rate	4.3	%	3.8	%
Expected term (years)	10.0		10.0
Expected volatility	125.6	%	91.3	%
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 six months ended March 31, 2024:


				Weighted
				Average
	Number	Exercise		Remaining
	of	Price		Contractual	Aggregate
	PSUs	Per PSU		Term (Years)	Intrinsic Value
Balance at October 1, 2023	123	$	999.40
Forfeitures	—		—
Balance at March 31, 2024	123	$	999.40	0.3	$	—
Exercisable at March 31, 2024	123	$	999.40	0.3	$	—
Vested and expected to vest at March 31, 2024	123	$	999.40	0.3	$	—

Commitments and Contingencies - Lease balance sheet (Details) - USD ($)	Mar. 31, 2024	Sep. 30, 2023
Leases
Operating leases, Right-of-use asset	$ 3,739	$ 26,172
Financing lease liabilities		$ 4,267
Operating leases, Weighted-average remaining lease term	1 month 6 days	7 months 6 days
Finance leases, Weighted-average remaining lease term		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%