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Commitments and Contingencies | 12 Months Ended
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Sep. 30, 2024
Commitments and Contingencies [Abstract] |
COMMITMENTS AND CONTINGENCIES | 8. COMMITMENTS AND CONTINGENCIES Operating Lease Effective July 1, 2019, we entered into a 76-month lease for office space in Cranford, NJ. We pay our proportionate share of real estate taxes and operating expenses in excess of the base year expenses. These costs are variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability. We identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities:
| ● | As the Cranford lease does not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company has estimated its incremental borrowing rate based on the remaining lease term as of the adoption date.
| ● | Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the combined lease component.
| ● | The expected lease terms include noncancelable lease periods.
The elements of lease expense are as follows:
Lease cost |  | Year Ended September 30, 2024 |  |  | Year Ended September 30, 2023 |
Operating lease cost |  | $ | 238,823 |  |  | $ | 238,824 |
Variable lease cost |  |  | 25,809 |  |  |  | 4,771 |
Total lease cost |  | $ | 264,632 |  |  | $ | 243,595 |
Other information |  |  |  |  |  |  |  |
Weighted-average remaining lease term - operating leases |  |  | 1.1 Years |  |  |  | 2.1 Years |
Weighted-average discount rate - operating leases |  |  | 8.0 | % |  |  | 8.0 | %
Maturities of lease liabilities due under the Company’s non-cancellable leases are as follows:
Year Ending September 30, |  |  |
2025 |  | $ | 253,883 |
2026 |  |  | 21,460 |
Total lease payments |  |  | 275,343 |
Less: interest |  |  | (12,478 | )
Present value of lease liabilities |  | $ | 262,865 |
Leases |  | Classification |  | September 30, 2024 |  |  | September 30, 2023 |
Assets |  |  |  |  |  |  |  |  |  |
Lease asset |  | Operating |  | $ | 246,247 |  |  | $ | 454,426 |
Total lease assets |  |  |  | $ | 246,247 |  |  | $ | 454,426 |
Liabilities |  |  |  |  |  |  |  |  |  |
Current |  | Operating |  | $ | 241,547 |  |  | $ | 218,380 |
Non-current |  | Operating |  |  | 21,318 |  |  |  | 262,865 |
Total lease liabilities |  |  |  | $ | 262,865 |  |  | $ | 481,245 |
Interest expense on the lease liability was $30,644 and $47,176 for the years ended September 30, 2024 and 2023, respectively. This amount is classified within general & administrative expense. Commercial Manufacturing Contracts The Company has entered into an agreement with a Contract Manufacturing Organization for the manufacture and supply of drug substance. The agreement runs through calendar 2026, with an automatic renewal for a subsequent 4-year term. Under this agreement, the Company is obligated to purchase minimum annual quantities of batches at a set price per batch, subject to annual increases. Additionally, the Company is required to pay an annual service fee of $250,000. The agreement also includes provisions for potential price increases based on increases in the manufacturer’s operating expenses or industry indices, as well as significant termination fees and obligations. As of September 30, 2024, the total minimum purchase commitment under this agreement was approximately $17.3 million consisting of payments of $11.9 million and $5.4 million for 2025 and 2026 respectively. As of September 30, 2024, the Company also has commercial supply agreements with two other vendors for the completion and packaging of finished drug products. Minimum purchase commitments under these two agreements amount to approximately $4.5 million consisting of purchase commitment obligations of $2.9 million in 2025 and $1.6 million in 2026. Legal Proceedings The Company is not involved in any litigation that it believes could have a material adverse effect on its financial position or results of operations. There is no action, suit, proceeding, inquiry, or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the Company’s executive officers, threatened against or affecting the Company or its officers or directors in their capacities as such.

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