Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2022 | Dec. 16, 2022 | Mar. 31, 2022 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Sep. 30, 2022 | ||
Entity File Number | 001-35963 | ||
Entity Registrant Name | NEUBASE THERAPEUTICS, INC. | ||
Entity Incorporation, State Code | DE | ||
Entity Tax Identification Number | 46-5622433 | ||
Entity Address, Address Line One | 350 Technology Drive, | ||
Entity Address, City or Town | Pittsburgh | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 15219 | ||
City Area Code | 412 | ||
Local Phone Number | 763-3350 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | NBSE | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 33,008,657 | ||
Entity Public Float | $ 57.9 | ||
Entity Central Index Key | 0001173281 | ||
Current Fiscal Year End Date | --09-30 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | Marcum LLP | ||
Auditor Location | New York, NY | ||
Auditor Firm ID | 688 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 23,152,663 | $ 52,893,387 |
Prepaid insurance | 319,699 | 499,061 |
Other prepaid expenses and current assets | 1,176,303 | 1,536,186 |
Total current assets | 24,648,665 | 54,928,634 |
EQUIPMENT, net | 2,156,851 | 2,463,882 |
OTHER ASSETS | ||
Investment | 0 | 415,744 |
Right-of-use asset, operating lease asset | 5,614,698 | 5,945,295 |
Security deposit | 273,215 | 253,615 |
Other long-term assets | 0 | 160,423 |
Total other assets | 5,887,913 | 6,775,077 |
TOTAL ASSETS | 32,693,429 | 64,167,593 |
CURRENT LIABILITIES | ||
Accounts payable | 1,843,027 | 1,807,885 |
Accrued expenses and other current liabilities | 1,662,660 | 1,747,746 |
Insurance note payable | 0 | 148,385 |
Operating lease liabilities | 553,066 | 382,576 |
Finance lease liabilities | 107,632 | 107,632 |
Total current liabilities | 4,166,385 | 4,194,224 |
Long-term operating lease liability | 5,335,164 | 5,794,096 |
Long-term finance lease liability | 0 | 109,500 |
TOTAL LIABILITIES | 9,501,549 | 10,097,820 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of September 30, 2022 and 2021 | 0 | 0 |
Common stock, $0.0001 par value; 250,000,000 shares authorized; 33,008,657 and 32,721,493 shares issued and outstanding as of September 30, 2022 and 2021, respectively | 3,300 | 3,272 |
Additional paid-in capital | 125,932,933 | 123,034,404 |
Accumulated deficit | (102,744,353) | (68,967,903) |
Total stockholders' equity | 23,191,880 | 54,069,773 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 32,693,429 | $ 64,167,593 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Sep. 30, 2021 |
Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized | 250,000,000 | 250,000,000 |
Common stock, issued | 33,008,657 | 32,721,493 |
Common stock, outstanding | 33,008,657 | 32,721,493 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
OPERATING EXPENSES | ||
General and administrative | $ 11,869,747 | $ 12,202,217 |
Research and development | 21,448,592 | 11,475,201 |
Research and development, Vera acquisition | 0 | 2,888,029 |
TOTAL OPERATING EXPENSES | 33,318,339 | 26,565,447 |
LOSS FROM OPERATIONS | (33,318,339) | (26,565,447) |
OTHER INCOME (EXPENSE) | ||
Interest expense | (24,047) | (32,330) |
Interest income | 148,556 | 12,550 |
Change in fair value of warrant liabilities | 0 | 950,151 |
Equity in losses on equity method investment | (415,747) | (224,534) |
Other (expense) income, net | (166,873) | 450,309 |
Total other (expense) income, net | (458,111) | 1,156,146 |
NET LOSS | $ (33,776,450) | $ (25,409,301) |
BASIC LOSS PER SHARE (in dollars per share) | $ (1.04) | $ (0.93) |
DILUTED LOSS PER SHARE (in dollars per share) | $ (1.04) | $ (0.93) |
WEIGHTED AVERAGE SHARES OUTSTANDING: | ||
BASIC | 32,487,244 | 27,306,043 |
DILUTED | 32,487,244 | 27,306,043 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance, beginning at Sep. 30, 2020 | $ 2,315 | $ 74,850,935 | $ (43,558,602) | $ 31,294,648 |
Balance, beginning, shares at Sep. 30, 2020 | 23,154,084 | |||
Stock-based compensation expense | 3,696,384 | 3,696,384 | ||
Issuance of restricted stock for services | $ 1 | (1) | ||
Issuance of restricted stock for services (in shares) | 11,722 | |||
Exercise of stock options | $ 5 | 112,441 | $ 112,446 | |
Exercise of stock options (in shares) | 47,052 | 47,052 | ||
Issuance of common stock, net of issuance costs | $ 920 | 42,615,456 | $ 42,616,376 | |
Issuance of common stock, net of issuance costs (in shares) | 9,200,000 | |||
Issuance of common stock, Vera acquisition | $ 31 | 1,759,189 | 1,759,220 | |
Issuance of common stock, Vera acquisition (in shares) | 308,635 | |||
Net loss | (25,409,301) | (25,409,301) | ||
Balance, ending at Sep. 30, 2021 | $ 3,272 | 123,034,404 | (68,967,903) | 54,069,773 |
Balance, ending, shares at Sep. 30, 2021 | 32,721,493 | |||
Stock-based compensation expense | 2,897,689 | 2,897,689 | ||
Issuance of restricted stock for services (in shares) | 4,441 | |||
Forfeiture of common stock | $ (51) | 51 | ||
Forfeiture of common stock (in shares) | (509,527) | |||
Exercise of stock options | $ 79 | 789 | $ 868 | |
Exercise of stock options (in shares) | 792,250 | 792,250 | ||
Net loss | (33,776,450) | $ (33,776,450) | ||
Balance, ending at Sep. 30, 2022 | $ 3,300 | $ 125,932,933 | $ (102,744,353) | $ 23,191,880 |
Balance, ending, shares at Sep. 30, 2022 | 33,008,657 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (33,776,450) | $ (25,409,301) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation | 2,897,689 | 3,696,384 |
Research and development, Vera acquisition | 0 | 2,888,029 |
Change in fair value of warrant liabilities | 0 | (950,151) |
Depreciation and amortization | 767,302 | 403,043 |
Loss on marketable securities | 30 | 25,012 |
Loss on disposal of fixed assets | 11,439 | 31,853 |
Equity in losses on equity method investment | 415,747 | 224,534 |
Gain on sale of intellectual property | 0 | (316,724) |
Amortization of right-of-use assets | 495,210 | 172,478 |
Changes in operating assets and liabilities | ||
Prepaid insurance, other prepaid expenses and current assets | 539,245 | (666,945) |
Long-term prepaid insurance | 0 | 145,250 |
Security deposit | (19,600) | (253,615) |
Other long-term assets | 160,423 | (160,420) |
Accounts payable | 35,142 | 294,548 |
Accrued expenses and other current liabilities | (85,088) | 943,442 |
Operating lease liability | (453,055) | 58,899 |
Net cash used in operating activities | (29,011,966) | (18,873,684) |
Cash flows from investing activities | ||
Purchase of laboratory and office equipment | (471,711) | (1,438,415) |
Purchase of marketable securities | (14,986,818) | (59,988,511) |
Sale of marketable securities | 14,986,788 | 59,963,499 |
Cash paid for Vera acquisition | 0 | (1,100,040) |
Net cash used in investing activities | (471,741) | (2,563,467) |
Cash flows from financing activities | ||
Principal payment of financed insurance | (148,385) | (381,797) |
Principal payment of finance lease liability | (109,500) | (8,770) |
Proceeds from issuance of stock, net of issuance costs | 0 | 42,616,376 |
Proceeds from exercise of stock options | 868 | 112,446 |
Net cash (used in) provided by financing activities | (257,017) | 42,338,255 |
Net (decrease) increase in cash and cash equivalents | (29,740,724) | 20,901,104 |
Cash and cash equivalents, beginning of period | 52,893,387 | 31,992,283 |
Cash and cash equivalents, end of period | 23,152,663 | 52,893,387 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 0 | 0 |
Cash paid for income taxes | 0 | 0 |
Non-cash investing and financing activities: | ||
Issuance of common stock, Vera acquisition | 0 | 1,759,220 |
Purchases of laboratory and office equipment in accounts payable | 0 | 8,295 |
Preferred shares in DepYmed received as consideration for sale of intellectual property | 0 | 316,724 |
Insurance financed through note payable | 0 | 391,625 |
Right-of-use asset obtained in exchange for operating lease liabilities | 164,613 | 0 |
Deferred offering costs accrued | $ 0 | $ 160,420 |
Organization, Description of Bu
Organization, Description of Business and Liquidity | 12 Months Ended |
Sep. 30, 2022 | |
Organization, Description of Business and Liquidity | |
Organization and Description of Business | 1. Organization, Description of Business and Liquidity NeuBase Therapeutics, Inc. and its subsidiaries (the “Company” or “NeuBase”) is developing a modular peptide-nucleic acid (“PNA”) antisense oligo (“PATrOL™”) platform to address genetic diseases, with a single, cohesive approach. NeuBase plans to use its platform to address diseases which have a genetic source, with an initial focus on gene silencing in myotonic dystrophy type 1 (“DM1”), Huntington’s disease (“HD”), and oncology, and in gene editing applications. NeuBase is a preclinical-stage biopharmaceutical company and continues to develop its clinical and regulatory strategy with its internal research and development team, with a view toward prioritizing market introduction as quickly as possible. NeuBase’s disclosed programs are NT-0100 in HD, NT-0200 in DM1 and NT-0300 in KRAS-driven cancers. The NT-0100 program is a PATrOL™-enabled therapeutic program being developed to target the mutant expansion in the HD DNA or RNA. The NT-0100 program includes proprietary PNAs which have the potential to be highly selective for the mutant copy of the gene versus the wild-type allele, the expectation being that the resultant therapy will be applicable for all HD patients as it directly targets the expansion itself, and the potential to be delivered systemically and address the brain and whole-body manifestations of the disease. PATrOL™-enabled drugs also have the unique ability to open DNA and RNA secondary structures and bind to either the primary nucleotide sequences or the secondary and/or tertiary structures. The NT-0200 program is a PATrOL™-enabled therapeutic program being developed to target the mutant expansion in the DM1 disease RNA. The NT-0200 program has the potential to be highly selective for the mutant transcript versus the wild-type transcribed allele and the expectation to be effective for nearly all DM1 patients as it directly targets the expansion itself. The NT-0300 program is a PATrOL-enabled therapeutic program being developed to target the mutated KRAS gene. The program is comprised of candidate compounds that target two activating mutations in the KRAS gene at the DNA or RNA levels: G12D and G12V. NeuBase believes these candidate compounds, and subsequent further optimized compounds, have the potential to inhibit transcription and/or translation of the oncogenic mutations and slow or stop tumor growth. In October 2022, the Company announced plans to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. The Company is currently identifying and evaluating multiple indications for potential future development. Liquidity and Going Concern The Company has had no revenues from product sales and has incurred operating losses since inception. As of September 30, 2022, the Company had $23.2 million in cash and cash equivalents and during the year ended September 30, 2022 incurred a loss from operations of $33.3 million and used $29.0 million of cash in operating activities. The Company expects to continue to incur substantial operating losses and negative cash flows from operations for the foreseeable future and may never become profitable. Accordingly, there are material risks and uncertainties that raised substantial doubt about the Company’s ability to continue as a going concern. In October 2022, as further discussed below, the Company announced a restructuring plan to reduce its operating expenses and extend its cash runway into the second quarter of calendar year 2024 based on current operating plans and estimates. Management believes it is probable that the restructuring plan will be effectively implemented within the next twelve months and that the restructuring plan, when implemented, will mitigate the conditions that gave rise to substantial doubt about the Company’s ability to continue as a going concern. Because the Company has sufficient resources on hand to fund operations through at least the next twelve months from the date these consolidated financial statements were available to be issued, the substantial doubt has been alleviated. There can be no assurance that the Company will be successful in acquiring additional funding, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years. The Company’s future liquidity and capital funding requirements will depend on numerous factors, including: ● its ability to raise additional funds to finance its operations; ● its ability to maintain compliance with the listing requirements of The Nasdaq Capital Market (“Nasdaq”); ● the outcome, costs and timing of preclinical and clinical trial results for the Company’s current or future product candidates; ● the extent and amount of any indemnification claims; ● litigation expenses and the extent and amount of any indemnification claims; ● the emergence and effect of competing or complementary products; ● its ability to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments the Company may be required to make, or that it may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; ● its ability to retain its current employees and the need and ability to hire additional management and scientific and medical personnel; ● the trading price of its common stock; and ● its ability to increase the number of authorized shares outstanding to facilitate future financing events. The Company will likely need to raise substantial additional funds through issuance of equity or debt or completion of a licensing transaction for one or more of the Company’s pipeline assets. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. Failure to obtain additional equity or debt financing will have a material, adverse impact on the Company’s business operations. There can be no assurance that the Company will be able to obtain the needed financing on acceptable terms or at all. Additionally, any equity financings would likely have a dilutive effect on the holdings of the Company’s existing stockholders. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Sep. 30, 2022 | |
Significant Accounting Policies | |
Significant Accounting Policies | 2. Significant Accounting Policies Basis of Presentation The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated during the consolidation process. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. Use of Estimates The preparation of 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 the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock-based compensation, the valuation of licenses, the fair value of warrant liabilities and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. The Company assesses and updates estimates each period to reflect current information, such as the economic considerations related to the impact that the novel coronavirus disease (COVID-19) could have on our significant accounting estimates. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents. Cash and cash equivalents are maintained in accounts with financial institutions which at times may exceed the Federal depository insurance coverage of $250,000. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant. Fair Value Measurements Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value: Level 1- Quoted prices in active markets for identical assets or liabilities on the reporting date. Level 2- Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3- Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models and fund manager estimates. Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Management’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. Marketable securities Marketable securities are classified as trading and are carried at fair value. The Company’s marketable securities consist of corporate bonds and highly liquid mutual funds, and exchange-traded and closed-end funds which are valued at quoted market prices. The Company had no marketable securities as of September 30, 2022 and 2021. Equipment Equipment is stated at cost less accumulated depreciation. Depreciation is provided on a straight-line basis over the estimated useful lives of the assets. The Company estimates useful lives as follows: ● Laboratory equipment: five years ● Office equipment: three years ● Leasehold improvements: lesser of useful life or lease term Impairment of Long-Lived Assets The Company reviews the carrying value of long-lived assets for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors that would be considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used and the effects of obsolescence, demand, competition and other economic factors. Based on this assessment, there was no impairment at September 30, 2022 and 2021. Investment The Company’s investment consists of common and preferred shares of DepYmed, Inc. Investments that the Company has the ability to exercise significant influence over are accounted for as equity method investments. Equity method investments are recorded at cost plus the proportional share of the issuer’s income or loss. Investments that do not have a readily determinable fair value and qualify for the measurement alternative for equity investments provided in ASC 321 are accounted for at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investment of the same issuer. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating right-of-use (“ROU”) assets and operating lease liabilities on the consolidated balance sheets. Equipment finance leases are included in equipment, net and finance lease liabilities on the consolidated balance sheets. Lease ROU assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using the Company’s incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. For operating leases, lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. For finance leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. The Company accounts for lease and non-lease components as a single lease component for all its leases. The Company does not recognize ROU assets and lease liabilities that arise from leases with an original term of 12 months or less. Rather, the Company recognizes the lease expense on a straight-line basis over the term of the lease. Research and Development The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of: ● salaries and related benefits for personnel in research and development functions, including stock-based compensation and benefits; ● fees paid to consultants and contract research organizations for preclinical development work on our PATrOL TM platform and programs; ● allocation of facility lease and maintenance costs; ● depreciation of laboratory equipment and computers; ● costs related to purchasing raw materials for and producing our product candidates; ● costs related to compliance with regulatory requirements; and ● license fees related to in-licensed technologies. Research and Development Expense- Licenses Acquired The Company evaluates whether acquired intangible assets are a business under applicable accounting standards. Additionally, the Company evaluates whether the acquired assets have an alternative future use. Intangible assets that do not have alternative future use are considered acquired in-process research and development. When the acquired in-process research and development assets are not part of a business combination, the value of the consideration paid is expensed on the acquisition date. Future costs to develop these assets are recorded to research and development expense as they are incurred. Stock-Based Compensation The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant date fair value of the awards and actual forfeitures. The Company accounts for forfeitures as they occur. Stock-based awards with graded vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment including: ● Volatility- The Company was historically a private company and in certain instances lacks sufficient company-specific historical and implied volatility information. Therefore, when insufficient company-specific information is available, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. ● Expected term- The expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The mid-point between the weighted-average vesting term and the expiration date is used as the expected term under this method. ● Risk-free rate- The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. ● Expected dividend- The expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. In accordance with this guidance, tax positions must meet a more likely than not recognition threshold and measurement attribute for the financial statement recognition and measurement of tax position. The Company’s policy is to account for income tax-related interest and penalties in income tax expense in the accompanying consolidated statements of operations. Net Loss Per Share Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the dilutive effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants and stock options that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted-average number of shares remains the same for both calculations due to the fact that when a net loss exists dilutive shares are not included in the calculation as the impact is anti-dilutive. Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The adoption of this standard as of October 1, 2021, did not impact the Company's consolidated financial statements and related disclosures. In November 2021, the FASB issued ASU No. 2021-10, "Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance", which amends disclosures to increase transparency of government assistance, including (i) the types of assistance, (ii) accounting for the assistance and (iii) the effect of the assistance on an entity's financial statements. The standard is effective for all business entities for annual periods beginning after December 15, 2021. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In June 2022, the FASB issued ASU 2022-03, "ASC Subtopic 820 Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions" ("ASU 2022-03"). ASU 2022-03 amends ASC 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the Company in fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact of this pronouncement on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). This guidance introduces a new model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses. ASU 2016-13 also provides updated guidance regarding the impairment of available-for-sale debt securities and includes additional disclosure requirements. The new guidance is effective for public business entities that meet the definition of a Smaller Reporting Company as defined by the Securities and Exchange Commission for interim and annual periods beginning after December 15, 2022. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In May 2021, the FASB issued ASU No. 2021-04, “Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2021-04”). This guidance reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. ASU 2021-04 provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. ASU 2021-04 will be effective for all entities for fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including adoption in an interim period. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
Asset Purchase Agreement
Asset Purchase Agreement | 12 Months Ended |
Sep. 30, 2022 | |
Asset Purchase Agreement | |
Asset Purchase Agreement | 3. Asset Purchase Agreement On January 27, 2021, the Company entered into an Asset Purchase Agreement by and among us, NeuBase Corporation, our wholly-owned subsidiary, and Vera Therapeutics, Inc. (“Vera”), as amended by the Amendment to Asset Purchase Agreement, dated as of April 20, 2021, by and between the Company and Vera (collectively, the “APA”), and the transaction closed on April 26, 2021 (the “Vera Acquisition”). Pursuant to the terms of the APA, the Company acquired infrastructure, materials, and intellectual property for PNA scaffolds from Vera for total consideration of approximately $0.8 million in cash and 308,635 shares of Common Stock (of which 146,375 were issued to Vera and 162,260 were held in escrow and released to Vera in accordance with the terms of an escrow agreement between NeuBase Corporation and Vera). The Company accounted for the Vera Acquisition as an asset acquisition. Total consideration for the Vera transaction consisted of the following: Cash consideration $ 796,124 Acquisition costs 303,916 Fair value of common stock (1) 1,759,220 Total consideration $ 2,859,260 (1) The fair value of common stock represents the closing share price of 308,635 shares of the Company’s common stock on April 26, 2021. The total consideration for the Vera transaction was allocated as follows: Property, plant and equipment $ 59,231 Other liabilities (88,000) Fair value of net assets acquired (28,769) Research and development expense 2,888,029 Total cost of Vera acquisition $ 2,859,260 In-process research and development assets with no future alternative use acquired in the Vera Acquisition were expensed. |
Equipment
Equipment | 12 Months Ended |
Sep. 30, 2022 | |
Equipment | |
Equipment | 4. Equipment The Company’s equipment consisted of the following: As of September 30, As of September 30, Estimated useful life 2022 2021 (in years) Laboratory equipment $ 3,175,019 $ 2,737,390 5 Office equipment 259,978 259,978 3 Leasehold improvements 17,958 — 5 Total 3,452,955 2,997,368 Accumulated depreciation and amortization (1,296,104) (533,486) Equipment, net $ 2,156,851 $ 2,463,882 Depreciation and amortization expense for the years ended September 30, 2022 and 2021 was approximately $0.8 million and $0.4 million, respectively. |
Other Prepaid Expenses and Othe
Other Prepaid Expenses and Other Current Assets | 12 Months Ended |
Sep. 30, 2022 | |
Other Prepaid Expenses and Other Current Assets | |
Other Prepaid Expenses and Other Current Assets | 5. Other Prepaid Expenses and Other Current Assets The Company’s prepaid expenses and other current assets consisted of the following: As of September 30, As of September 30, 2022 2021 Prepaid research and development expense $ 805,542 $ 583,267 Prepaid rent — 172,518 Franchise tax receivable 127,715 — Other prepaid expenses and other current assets 243,046 780,401 Total $ 1,176,303 $ 1,536,186 |
Investment
Investment | 12 Months Ended |
Sep. 30, 2022 | |
Investment | |
Investment | 6. Investment On February 26, 2014, Ohr entered into a Joint Venture Agreement and related agreements with Cold Spring Harbor Laboratory (“CSHL”) pursuant to which a joint venture, DepYmed Inc. (“DepYmed”), was formed to further preclinical and clinical development of the Company’s intellectual property for rare diseases and oncology. DepYmed licenses research from CSHL and intellectual property from the Company. Following the 2019 merger with Ohr Pharmaceutical, Inc., (the “Ohr Acquisition”), the Company owns common and preferred shares of DepYmed. In addition, in February 2021, the Company sold certain intellectual property to DepYmed in exchange for shares of Series A-4 preferred stock. In aggregate, the Company's ownership represents approximately 15% ownership of DepYmed. The Company accounts for its investment in DepYmed common shares using the equity method of accounting and records its proportionate share of DepYmed’s net income and losses in the accompanying consolidated statements of operations. The Company accounts for its investment in preferred shares of DepYmed at cost, less any impairment, as the Company determined the preferred stock did not have a readily determinable fair value. The carrying value of the Company’s investment in DepYmed common shares was reduced to zero ; therefore, during the year ended September 30, 2022, the Company recorded its share of equity losses to the extent of its investment in preferred shares of DepYmed. The Company will continue to monitor the operating results of DepYmed and will record equity in earnings when the equity in earnings exceeds the previously unrecognized losses. Equity in losses for the years ended September 30, 2022 and 2021 were approximately $0.4 million and $0.2 million, respectively. The carrying value of the Company’s total investment is DepYmed is as follows: As of September 30, 2022 2021 Carrying value of DepYmed common shares $ — $ — Fair value of DepYmed preferred shares assumed in connection with acquisition of Ohr — 99,020 DepYmed preferred shares received in sale of intellectual property — 316,724 Total Investment $ — $ 415,744 The Company recognized a gain of $0.3 million related to the sale of IP to DepYmed, which was recorded in other (expense) income, net on the Company's consolidated statement of operations for the year ended September 30, 2021. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 7. Accrued Expenses and Other Current Liabilities The Company’s accrued expenses and other current liabilities consisted of the following: As of September 30, 2022 2021 Accrued compensation and benefits $ 768,324 $ 880,707 Accrued consulting settlement 150,000 200,000 Accrued professional fees 191,516 299,557 Accrued research and development 512,570 297,047 Accrued franchise tax 36,542 30,720 Other accrued expenses 3,708 39,715 Total $ 1,662,660 $ 1,747,746 |
Notes Payable
Notes Payable | 12 Months Ended |
Sep. 30, 2022 | |
Notes Payable | |
Notes Payable | 8. Notes Payable Insurance Note Payable As of September 30, 2022 and 2021, the Company had the following insurance note payable outstanding: Stated Interest Original Balance at September 30, Maturity Date Rate Principal 2022 2021 Insurance Note Payable 2021 Insurance Note January 2022 4.99 % $ 391,625 $ — $ 148,385 The Company paid off the insurance note as of September 30, 2022. |
Leases
Leases | 12 Months Ended |
Sep. 30, 2022 | |
Leases | |
Leases | 9. Leases In October 2020, the Company entered into a ten-year operating lease agreement with annual escalating rental payments for approximately 14,189 square feet of office and laboratory space in Pittsburgh, PA. The leased premises serves as the Company’s headquarters. The first and second amendments to the lease agreement were executed in December 2020 and April 2021, respectively (collectively with the lease agreement, referred to herein as the “Lease”). In November 2020, the Company prepaid rent of $0.3 million and paid a security deposit of $0.3 million for the Lease. The Lease commenced on May 1, 2021, and the Company was obligated to begin making rental payments on this date. The Company applied the prepaid amount toward the rental payments through December 2021. The Company measured and recognized an initial ROU asset and operating lease liability upon lease commencement. The Company has the right to extend the term of the Lease for an additional five-year term; however, this extension has not been included in the calculation of the lease liability and ROU asset at the lease inception as the exercise of the option was not reasonably certain. The Company continued to operate under its operating lease in Pittsburgh until the Company moved into its new headquarters and laboratory space, which occurred in June 2021. The Company’s prior office and operating space was leased under operating leases with original terms of less than 12 months, which expired at various dates through November 2021; therefore, the Company’s previous operating leases were not recognized as ROU assets on the consolidated balance sheets. The Company also maintained a short-term rental of office space in San Diego, CA and New York, NY, which expired in November 2021. In October 2021, the Company commenced a one-year lease for the rental of office space in Boston, MA, which was subsequently extended through April 2023. In August 2021, the Company entered into a two-year finance lease for certain laboratory equipment. The Company measured and recognized an initial ROU asset and finance lease liability upon lease commencement. In February 2022, the Company entered into an eighteen-month lease agreement for private and shared laboratory facilities for general laboratory and office space in Boston, MA. The Company measured and recognized the ROU asset and operating lease liability upon the lease commencement. At September 30, 2022, ROU assets and lease liabilities were as follows: As of September 30, 2022 2021 Assets: Classification Operating lease right-of-use-asset Operating lease asset $ 5,614,698 $ 5,945,295 Financing lease right-of-use-asset Equipment, net 103,538 216,490 $ 5,718,236 $ 6,161,785 Liabilities: Current Classification Operating Operating lease liability $ 553,066 $ 382,576 Financing Financing lease liability 107,632 107,632 Long-term Operating Long-term portion of operating leases liability 5,335,164 5,794,096 Financing Long-term portion of financing leases liability — 109,500 $ 5,995,862 $ 6,393,804 The following tables summarize quantitative information about the Company’s leases for the years ended September 30, 2022 and 2021: Year Ended September 30, 2022 2021 Operating cash flows - operating leases $ 901,060 $ 128,963 Operating cash flows - financing leases 12,252 1,376 Financing cash flows - financing leases 109,500 8,770 Right-of-use asset obtained in exchange for operating lease liabilities $ 164,613 $ 6,117,772 Finance lease assets obtained in exchange for finance lease liabilities — 225,902 As of September 30, 2022 2021 Weighted-average remaining lease term – operating leases (in years) 8.74 9.83 Weighted-average discount rate – operating leases 7.3 % 7.3 % Weighted-average remaining lease term – financing leases (in years) 0.9 1.9 Weighted-average discount rate – financing leases 7.3 % 7.3 % The components of lease expense were as follows: Year Ended September 30, 2022 2021 Operating leases Operating lease cost $ 943,215 $ 360,340 Variable lease costs 2,400 18,216 Total operating lease cost 945,615 378,556 Short-term lease rent expense 40,719 113,158 Financing leases Amortization of leased assets 112,951 9,413 Interest on lease liabilities 12,252 1,376 Financing lease cost 125,203 10,789 Net lease cost $ 1,111,537 $ 502,503 As of September 30, 2022, future minimum lease payments under the non-cancelable leases were as follows: Operating Financing Leases Leases Year Ending September 30, 2023 $ 965,367 $ 111,606 Year Ending September 30, 2024 874,320 — Year Ending September 30, 2025 881,391 — Year Ending September 30, 2026 888,627 — Year Ending September 30, 2027 895,864 — Thereafter 3,505,166 — Total 8,010,735 111,606 Less present value discount (2,122,505) (3,974) Operating lease liabilities $ 5,888,230 $ 107,632 |
Fair Value
Fair Value | 12 Months Ended |
Sep. 30, 2022 | |
Fair Value | |
Fair Value | 10. Fair Value Prior to their expiration during the year ended September 30, 2022, warrant liabilities were measured at fair value on a recurring basis. Fair Value Measurements as of September 30, 2022 (Level 1) (Level 2) (Level 3) Total Liabilities Warrant liabilities $ — — — $ — Fair Value Measurements as of September 30, 2021 (Level 1) (Level 2) (Level 3) Total Liabilities Warrant liabilities $ — — — $ — The following assumptions were used in determining the fair value of the warrant liabilities as of September 30, 2021: As of September 30, 2021 Remaining contractual term (years) 0.2 - 0.5 Common stock price volatility 60.6% - 62.5% Risk-free interest rate 0.04% Expected dividend yield — During the year ended September 30, 2021, the Company utilized its historical volatility in the valuation of warrant liabilities as it had sufficient trading activity. The change in fair value of the warrant liabilities for the years ended September 30, 2022 and 2021 is as follows: Fair value as of September 30, 2020 $ 950,151 Change in fair value (950,151) Fair value as of September 30, 2021 — Change in fair value — Fair value as of September 30, 2022 $ — As of September 30, 2022 and 2021, the recorded values of cash and cash equivalents, accounts payable and the insurance note payable approximate fair value due to the short-term nature of the instruments. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 11. Stockholders’ Equity Preferred Stock The Company is authorized to issue 10 million shares of preferred stock, par value $0.0001 as of September 30, 2022 and 2021. No shares of preferred stock were issued or outstanding as of September 30, 2022 or 2021. Common Stock The Company has authorized 250 million shares of common stock, $0.0001 par value per share as of September 30, 2022 and 2021. Each share of common stock is entitled to one voting right. Common stock owners are entitled to dividends when funds are legally available and declared by the Company’s board of directors. During the year ended September 30, 2022, a former employee forfeited 509,527 shares of common stock for no consideration. Common Stock Offerings On April 26, 2021, the Company closed an underwritten public offering of 9,200,000 shares of its common stock (inclusive of 1,200,000 shares that were sold pursuant to the underwriters’ full exercise of their option to purchase additional shares of the Company’s common stock), at a price to the public of $5.00 per share. The Company received net proceeds from the offering of approximately $42.6 million, after deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company. Warrants Below is a summary of the Company’s issued and outstanding warrants as of September 30, 2022: Expiration date Exercise Price Warrants Outstanding July 6, 2023 $ 8.73 105,000 September 20, 2024 6.50 75,000 180,000 Weighted- Weighted- Average Average Remaining Exercise Contractual Life Warrants Price (in years) Outstanding as of September 30, 2020 820,939 $ 19.44 Issued 75,000 6.50 Outstanding as of September 30, 2021 895,939 18.35 0.9 Expired (715,939) 21.01 Outstanding as of September 30, 2022 180,000 7.80 1.3 Exercisable as of September 30, 2022 180,000 7.80 1.3 During the year ended September 30, 2022, the Company did not issue warrants. During the year ended September 30, 2021, the Company issued 75,000 warrants in exchange for certain financial advisory services. The warrants vest over six-month periods, have exercise prices of $6.50 per share, and expire three years from issuance. The Company determined the warrants issued in exchange for financial advisory services met the scope exception in ASC 815 and are therefore classified as equity. The Company determined the initial fair value of the advisory warrants issued during the year ended September 30, 2021 to be $0.1 million, which was recognized as stock-based compensation expense over the vesting period of the warrants, see Note 13. Key assumptions used to estimate the fair value of the advisory warrants granted during the year ended September 30, 2021 were as follows: As of September 30, 2021 Remaining contractual term (years) 3.0 Common stock price volatility 83.9 % Risk-free interest rate 0.5 % Expected dividend yield — As of September 30, 2022, the balance of unrecognized compensation expense associated with the advisory warrants was $0. |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 12. Net Loss Per Common Share The following potentially dilutive securities outstanding for the years ended September 30, 2022 and 2021 have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive: As of September 30, 2022 2021 Common stock purchase options 7,629,281 7,397,154 Restricted stock units — 10,000 Common stock purchase warrants 180,000 895,939 7,809,281 8,303,093 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 13. Stock-Based Compensation The Company has a 2016 Consolidated Stock Incentive Plan (the “2016 Plan”) and a 2019 Stock Incentive Plan (the “2019 Plan”), which provide for the issuance of incentive and non-incentive stock options, restricted and unrestricted stock awards, stock unit awards and stock appreciation rights. Options and restricted stock units granted generally vest over a period of one As of September 30, 2022, an aggregate of 6,018,136 shares of common stock were authorized under the 2019 Plan, subject to an “evergreen” provision that will automatically increase the maximum number of shares of Common Stock that may be issued under the terms of the 2019 Plan. As of September 30, 2022, 697,893 common shares were available for future grants under the 2019 Plan. As of September 30, 2022, 291,667 shares of common stock were authorized under the 2016 Plan and 147,041 common shares were available for future grants under the 2016 Plan. The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations for the years ended September 30, 2022 and 2021: Year Ended September 30, 2022 2021 General and administrative $ 1,817,797 $ 2,369,287 Research and development 1,079,892 1,327,097 Total $ 2,897,689 $ 3,696,384 Stock Options Below is a table summarizing the options issued and outstanding as of and for the years ended September 30, 2022 and 2021: Weighted- Weighted- Average Total Average Remaining Aggregate Exercise Contractual Intrinsic Stock Options Price Life (in years) Value Outstanding at September 30, 2020 6,190,790 $ 2.76 Granted 1,758,599 5.45 Exercised (47,052) 2.39 Forfeited (505,183) 6.80 Outstanding at September 30, 2021 7,397,154 3.13 Granted 1,768,365 2.14 Exercised (792,250) 0.00 Forfeited (743,988) 4.74 Outstanding at September 30, 2022 7,629,281 3.08 6.8 $ 992,754 Exercisable as of September 30, 2022 5,017,592 $ 2.90 5.7 $ 992,754 As of September 30, 2022, the unrecognized compensation costs of $2.5 million will be recognized over an estimated weighted-average amortization period of 1.4 years. The intrinsic value of stock options exercised during the years ended September 30, 2022 and 2021 was $0.4 million and $0.2 million, respectively. The weighted average grant date fair value of options granted during the year ended September 30, 2022 and 2021 was $1.40 and $3.84, respectively. Key assumptions used to estimate the fair value of the stock options granted during the years ended September 30, 2022 and 2021 included: Year Ended September 30, 2022 2021 Expected term of options (years) 5.1 - 6.1 6.1 Expected common stock price volatility 73.8% - 78.5% 82.7% - 83.7% Risk-free interest rate 1.1% - 3.4% 0.6% - 1.3% Expected dividend yield — — During the fiscal year ended September 30, 2021, the Company granted a stock option to purchase 225,000 shares to a consultant, which was cancelled and reissued in June 2021, in recognition of future service to the Company as an employee. The exercisability and vesting of the stock options are subject to the consultant’s effective date of employment with the Company, which had not yet occurred as of September 30, 2022, and as a result, the grant date of such option has not occurred under GAAP. Therefore, the number and fair value of the shares subject to this option are not reflected in the table summarizing the options issued and outstanding as of and for the year ended September 30, 2022 and did not have impact on unrecognized compensation costs or the estimated weighted-average amortization period above as of September 30, 2022. Restricted Stock A summary of the changes in the outstanding restricted stock during the years ended September 30, 2022 and 2021 is as follows: Weighted-Average Grant Date Unvested Restricted Fair Value Stock Price Unvested as of September 30, 2020 — $ — Granted 11,722 6.37 Vested (11,722) 6.37 Unvested as of September 30, 2021 — — Granted 4,441 3.94 Vested (4,441) 3.94 Unvested as of September 30, 2022 — — Total unrecognized expense remaining $ — Weighted-average years expected to be recognized over — The fair value of restricted stock that vested during the years ended September 30, 2022 and 2021 was $0.02 million and $0.1 million, respectively. Restricted Stock Units Below is a table summarizing the restricted stock units granted and outstanding as of and for the year ended September 30, 2022: Weighted-Average Grant Date Restricted Stock Fair Value Units Price Unvested as of September 30, 2021 10,000 $ 5.09 Forfeited (10,000) 5.09 Unvested as of September 30, 2022 — — Total unrecognized expense remaining $ — Weighted-average years expected to be recognized over — |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Income Taxes | 14. Income Taxes The Company has accumulated net losses since inception and has not recorded an income tax provision or benefit for the United States (U.S.) federal and state income taxes during the years ended September 30, 2022 and 2021. The components of the income tax benefits, net are as follows: For the Year Ended September 30, 2022 2021 Federal Current $ — $ — Deferred (6,780,606) (7,919,279) State and Local Current — — Deferred (2,746,540) (3,015,187) Change in valuation allowance 9,527,146 10,934,466 Income tax provision (benefit) $ — $ — A reconciliation of income taxes at the statutory federal income tax rate to net income taxes included in the consolidated statements of operations is as follows: For the Year Ended September 30, 2022 2021 U.S. federal income tax expense at the statutory rate (21.0) % (21.0) % State income taxes, net of federal taxes (7.7) (7.9) Stock-based compensation 1.0 1.2 Return to provision adjustment (0.5) (14.2) Other permanent items — (1.1) Change in valuation allowance 28.2 43.0 Income tax provision (benefit) — % — % The components of our deferred tax assets and liabilities are: September 30, 2022 2021 Deferred tax assets Net operating loss carryforwards $ 22,461,508 $ 13,254,067 Stock-based compensation 4,072,264 3,779,555 Amortization 2,277,085 2,643,500 Service Warrant 180,276 147,168 Investment 263,073 141,098 Other 50,979 — Lease liability 1,715,159 66,982 Total deferred tax assets 31,020,344 20,032,370 Deferred tax liabilities Depreciation (158,317) (127,449) ROU assets (1,635,483) — Prepaid expenses — (205,523) Total deferred tax liabilities (1,793,800) (332,972) Valuation allowance (29,226,544) (19,699,398) Net deferred tax assets, net of allowances $ — $ — As of each reporting date, the Company considers existing evidence, both positive and negative, that could impact its view with regard to future realization of deferred tax assets. The Company believes that it is more likely than not that the benefit for deferred tax assets will not be realized. In recognition of this uncertainty, a full valuation allowance was applied to the deferred tax assets. The Company did not record a tax provision for the years ended September 30, 2022 and September 30, 2021 due to the Company’s estimate that the effective tax rate for each year is 0%. Future realization depends on the Company’s future earnings, if any, the timing and amount of which are uncertain as of September 30, 2022. In the future, should management conclude that it is more likely than not that the deferred tax assets are partially or fully realizable, the valuation allowance would be reduced to the extent of such expected realization and the amount would be recognized as a deferred income tax benefit in the Company’s consolidated statements of operations. As of September 30, 2022, the Company had available federal and state total net operating loss carryforwards of approximately $77.1 million. Federal net operating loss carryforwards of approximately $77.1 million carryforward indefinitely. State operating loss carryforwards of approximately $77.1 million begin to expire in 2024. Pursuant to Section 382 of the Internal Revenue Code of 1986, as amended, the Company’s federal and state net operating loss carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not completed a Section 382 analysis regarding the limitation of net operating loss carryforwards. There is a risk that changes in ownership have occurred since the Company’s formation. If a change in ownership were to have occurred, the NOL carryforwards could be limited or restricted. If limited, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, related to the Company’s operations will not impact the Company’s effective tax rate. There are open statutes of limitations whereby our US Federal and state tax returns from inception of the Company are subject to audit by the respective taxing authorities in these jurisdictions for taxing authorities in federal and state jurisdictions to audit our tax returns from inception of the Company. There have been no material income tax-related interest or penalties assessed or recorded. No liability for uncertain tax positions or related interest and penalties related to uncertain tax positions is reported in the Company’s consolidated financial statements. The Inflation Reduction Act of 2022 (the “IRA”), which was signed into law in August 2022, includes several provisions that are specifically applicable to corporations. Among other changes, it created a new corporate alternative minimum tax based on adjusted financial statement income and imposes a 1% excise tax on corporate stock repurchases. The effective date of these provisions is January 1, 2023. The Company does not expect the enactment of the IRA will have an impact on its consolidated financial statements. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 15. Commitments and Contingencies Employee Benefit Plans The Company has a defined contribution savings and investment plan (the “Plan”) as allowed under Sections 401(k) and 401(a) of the Internal Revenue Code. The Plan provides employees with tax deferred salary deductions and alternative investment options. Employees are eligible to participate upon employment and may apply for and secure loans from their account in the Plan. The Company contributed approximately $134,927 and $14,158, respectively, to the Plan during the years ended September 30, 2022 and 2021 as an employee match contribution. Litigation The Company may become involved in certain legal proceedings and claims which arise in the normal course of business. If an unfavorable ruling were to occur, there exists the possibility of a material adverse impact on the Company’s results of operations, prospects, cash flows, financial position and brand. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. Securities Litigation On February 14, 2018, plaintiff Jeevesh Khanna, commenced an action in the Southern District of New York, against Ohr, which entered into a merger agreement with Legacy NeuBase on January 2, 2019 and which merger closed on July 12, 2019, and several of its current and former officers and directors, alleging that they violated federal securities laws between June 24, 2014 and January 4, 2018. On August 7, 2018, the lead plaintiffs, now George Lehman and Insured Benefit Plans, Inc., filed an amended complaint, alleging a putative class period of April 8, 2014 through January 4, 2018. The plaintiffs did not quantify any alleged damages in their complaint, but, in addition to attorneys’ fees and costs, they seek to maintain the action as a class action and to recover damages on behalf of themselves and other persons who purchased or otherwise acquired Ohr common stock during the putative class period and purportedly suffered financial harm as a result. Ohr and the individuals dispute these claims and are defending the matter vigorously. On September 17, 2018, Ohr filed a motion to dismiss the complaint. On September 20, 2019, the district court issued an opinion and order granting the motion to dismiss. On October 23, 2019, the plaintiffs filed a notice of appeal of that order dismissing the action. After full briefing and oral argument, on October 9, 2020, the U.S. Court of Appeals for the Second Circuit issued a summary order affirming the district court’s order granting the motion to dismiss and remanding the action to the district court to make a determination on the record related to plaintiffs’ request for leave to file an amended complaint. On remand, the district court denied plaintiffs’ subsequent request to amend and dismissed with prejudice plaintiffs’ claims. On December 16, 2020, plaintiffs filed a notice of appeal of that order denying plaintiffs leave to amend. On December 16, 2021, the Second Circuit affirmed the decision and order of the district court denying plaintiffs’ motion for leave to amend, thereby dismissing the appeal and action in its entirety. Plaintiffs have neither sought reconsideration of the Second Circuit's decision nor filed a writ of certiorari for review by the Supreme Court. This matter is now considered closed. Derivative Lawsuit On May 3, 2018, plaintiff Adele J. Barke, derivatively on behalf of Ohr, commenced an action against Michael Ferguson, Orin Hirschman, Thomas M. Riedhammer, June Almenoff and Jason Slakter in the Supreme Court, State of New York, alleging that the action was brought in the right and for the benefit of Ohr seeking to remedy their “breach of fiduciary duties, corporate waste and unjust enrichment that occurred between June 24, 2014 and the present.” It does not quantify any alleged damages. On March 30, 2022, plaintiff filed a notice of voluntary dismissal of the complaint in this action. This matter is now considered closed. Joint Proxy Statement Lawsuit Following the issuance of the preliminary joint proxy statement/prospectus related to the merger of the Company and Ohr, on March 18, 2019, the Gomez Action was filed by an individual shareholder in the United States District Court for the Southern District of New York against Ohr and its board of directors. The plaintiff in the Gomez Action alleges that the preliminary joint proxy/prospectus statement filed by Ohr with the SEC on March 8, 2019 contained false and misleading statements and omitted material information in violation of Section 14(a) of the Exchange Act and SEC Rule 14a-9 promulgated thereunder, and further that the individual defendants are liable for those alleged misstatements and omissions under Section 20(a) of the Exchange Act. On March 19, 2019, the Barke Action was filed in the United States District Court for the Southern District of New York asserting similar Section 14(a) and Section 20(a) claims against Ohr's board of directors and additionally naming NeuBase and Ohr Acquisition Corp., but not Ohr, as defendants. On March 20, 2019, the Wheby Action was filed in the United States District Court for District of Delaware asserting similar claims under Section 14(a) and Section 20(a) and naming as defendants Ohr and its board of directors, NeuBase, and Ohr Acquisition Corp. On March 20, 2019, the Lowinger Action was filed in the Court of Chancery of the State of Delaware asserting a breach of fiduciary duty claim against Ohr's board of directors arising out of the same facts and circumstances regarding certain alleged omissions in the preliminary joint proxy/prospectus statement. On April 4, 2019, the Garaygordobil Action was filed in the United States District Court for the Southern District of New York asserting similar Section 14(a) and Section 20(a) claims against Ohr and its board of directors. Each of the Gomez, Barke, Garaygordobil, and Lowinger Actions have been dismissed, and on July 12, 2019, the Company and Ohr consummated the Merger. On March 23, 2022, plaintiffs in the Wheby Action filed a notice of voluntary dismissal of the complaint and this case was closed. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Sep. 30, 2022 | |
Subsequent Events | |
Subsequent Events | 16. Subsequent Events In October 2022, the Company announced a strategic restructuring to expand its focus to include the advancement of the differentiated gene editing capabilities of its platform. As part of the development pipeline shift to gene editing, the Company will defer preclinical activities for its DM1, HD, and KRAS programs, hold plans to submit an IND application for DM1 to the FDA, and pursue collaborative initiatives, including partnerships, for these programs. The Company estimates that it will incur total expenses relating to the restructuring of approximately $0.5 million, consisting of severance and termination-related costs, and expects to record a significant portion of these charges in the fourth quarter of calendar year 2022. This restructuring plan is expected to extend the Company’s cash runway into the second quarter of calendar year 2024 based on current operating plans and estimates. As part of the cost reduction plan, the Company implemented a cross-functional reduction of approximately 60% of the then-current workforce. In October 2022, the Company also announced certain changes to its leadership team, including the resignations of the Head of Research and Development and Chief Medical Officer and President and Chief Operating Officer, as well as the appointment of Dr. Dov A. Goldstein, a member of the Company’s board of directors since 2019, as Chairperson of the Board. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2022 | |
Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated during the consolidation process. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. |
Use of Estimates | Use of Estimates The preparation of 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 the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock-based compensation, the valuation of licenses, the fair value of warrant liabilities and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. The Company assesses and updates estimates each period to reflect current information, such as the economic considerations related to the impact that the novel coronavirus disease (COVID-19) could have on our significant accounting estimates. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents. Cash and cash equivalents are maintained in accounts with financial institutions which at times may exceed the Federal depository insurance coverage of $250,000. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant. |
Fair Value Measurements | Fair Value Measurements Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value: Level 1- Quoted prices in active markets for identical assets or liabilities on the reporting date. Level 2- Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3- Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models and fund manager estimates. Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Management’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. |
Marketable Securities | Marketable securities Marketable securities are classified as trading and are carried at fair value. The Company’s marketable securities consist of corporate bonds and highly liquid mutual funds, and exchange-traded and closed-end funds which are valued at quoted market prices. The Company had no marketable securities as of September 30, 2022 and 2021. |
Equipment | Equipment Equipment is stated at cost less accumulated depreciation. Depreciation is provided on a straight-line basis over the estimated useful lives of the assets. The Company estimates useful lives as follows: ● Laboratory equipment: five years ● Office equipment: three years ● Leasehold improvements: lesser of useful life or lease term |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews the carrying value of long-lived assets for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors that would be considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used and the effects of obsolescence, demand, competition and other economic factors. Based on this assessment, there was no impairment at September 30, 2022 and 2021. |
Investment | Investment The Company’s investment consists of common and preferred shares of DepYmed, Inc. Investments that the Company has the ability to exercise significant influence over are accounted for as equity method investments. Equity method investments are recorded at cost plus the proportional share of the issuer’s income or loss. Investments that do not have a readily determinable fair value and qualify for the measurement alternative for equity investments provided in ASC 321 are accounted for at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investment of the same issuer. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating right-of-use (“ROU”) assets and operating lease liabilities on the consolidated balance sheets. Equipment finance leases are included in equipment, net and finance lease liabilities on the consolidated balance sheets. Lease ROU assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using the Company’s incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. For operating leases, lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. For finance leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. The Company accounts for lease and non-lease components as a single lease component for all its leases. The Company does not recognize ROU assets and lease liabilities that arise from leases with an original term of 12 months or less. Rather, the Company recognizes the lease expense on a straight-line basis over the term of the lease. |
Research and Development | Research and Development The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of: ● salaries and related benefits for personnel in research and development functions, including stock-based compensation and benefits; ● fees paid to consultants and contract research organizations for preclinical development work on our PATrOL TM platform and programs; ● allocation of facility lease and maintenance costs; ● depreciation of laboratory equipment and computers; ● costs related to purchasing raw materials for and producing our product candidates; ● costs related to compliance with regulatory requirements; and ● license fees related to in-licensed technologies. Research and Development Expense- Licenses Acquired The Company evaluates whether acquired intangible assets are a business under applicable accounting standards. Additionally, the Company evaluates whether the acquired assets have an alternative future use. Intangible assets that do not have alternative future use are considered acquired in-process research and development. When the acquired in-process research and development assets are not part of a business combination, the value of the consideration paid is expensed on the acquisition date. Future costs to develop these assets are recorded to research and development expense as they are incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant date fair value of the awards and actual forfeitures. The Company accounts for forfeitures as they occur. Stock-based awards with graded vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment including: ● Volatility- The Company was historically a private company and in certain instances lacks sufficient company-specific historical and implied volatility information. Therefore, when insufficient company-specific information is available, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. ● Expected term- The expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The mid-point between the weighted-average vesting term and the expiration date is used as the expected term under this method. ● Risk-free rate- The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. ● Expected dividend- The expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. In accordance with this guidance, tax positions must meet a more likely than not recognition threshold and measurement attribute for the financial statement recognition and measurement of tax position. The Company’s policy is to account for income tax-related interest and penalties in income tax expense in the accompanying consolidated statements of operations. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the dilutive effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants and stock options that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted-average number of shares remains the same for both calculations due to the fact that when a net loss exists dilutive shares are not included in the calculation as the impact is anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The adoption of this standard as of October 1, 2021, did not impact the Company's consolidated financial statements and related disclosures. In November 2021, the FASB issued ASU No. 2021-10, "Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance", which amends disclosures to increase transparency of government assistance, including (i) the types of assistance, (ii) accounting for the assistance and (iii) the effect of the assistance on an entity's financial statements. The standard is effective for all business entities for annual periods beginning after December 15, 2021. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In June 2022, the FASB issued ASU 2022-03, "ASC Subtopic 820 Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions" ("ASU 2022-03"). ASU 2022-03 amends ASC 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the Company in fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact of this pronouncement on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). This guidance introduces a new model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses. ASU 2016-13 also provides updated guidance regarding the impairment of available-for-sale debt securities and includes additional disclosure requirements. The new guidance is effective for public business entities that meet the definition of a Smaller Reporting Company as defined by the Securities and Exchange Commission for interim and annual periods beginning after December 15, 2022. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In May 2021, the FASB issued ASU No. 2021-04, “Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2021-04”). This guidance reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. ASU 2021-04 provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. ASU 2021-04 will be effective for all entities for fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including adoption in an interim period. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
Asset Purchase Agreement (Table
Asset Purchase Agreement (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Asset Purchase Agreement | |
Summary of consideration for the Vera transaction | Total consideration for the Vera transaction consisted of the following: Cash consideration $ 796,124 Acquisition costs 303,916 Fair value of common stock (1) 1,759,220 Total consideration $ 2,859,260 (1) The fair value of common stock represents the closing share price of 308,635 shares of the Company’s common stock on April 26, 2021. |
Summary of allocation of total consideration for the Vera transaction | The total consideration for the Vera transaction was allocated as follows: Property, plant and equipment $ 59,231 Other liabilities (88,000) Fair value of net assets acquired (28,769) Research and development expense 2,888,029 Total cost of Vera acquisition $ 2,859,260 |
Equipment (Tables)
Equipment (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Equipment | |
Schedule of equipment | As of September 30, As of September 30, Estimated useful life 2022 2021 (in years) Laboratory equipment $ 3,175,019 $ 2,737,390 5 Office equipment 259,978 259,978 3 Leasehold improvements 17,958 — 5 Total 3,452,955 2,997,368 Accumulated depreciation and amortization (1,296,104) (533,486) Equipment, net $ 2,156,851 $ 2,463,882 |
Other Prepaid Expenses and Ot_2
Other Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Other Prepaid Expenses and Other Current Assets | |
Summary of prepaid expenses and other current assets | As of September 30, As of September 30, 2022 2021 Prepaid research and development expense $ 805,542 $ 583,267 Prepaid rent — 172,518 Franchise tax receivable 127,715 — Other prepaid expenses and other current assets 243,046 780,401 Total $ 1,176,303 $ 1,536,186 |
Investment (Tables)
Investment (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Investment | |
Schedule of carrying value of the Company's total investment in DepYmed | As of September 30, 2022 2021 Carrying value of DepYmed common shares $ — $ — Fair value of DepYmed preferred shares assumed in connection with acquisition of Ohr — 99,020 DepYmed preferred shares received in sale of intellectual property — 316,724 Total Investment $ — $ 415,744 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | As of September 30, 2022 2021 Accrued compensation and benefits $ 768,324 $ 880,707 Accrued consulting settlement 150,000 200,000 Accrued professional fees 191,516 299,557 Accrued research and development 512,570 297,047 Accrued franchise tax 36,542 30,720 Other accrued expenses 3,708 39,715 Total $ 1,662,660 $ 1,747,746 |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Notes Payable | |
Schedule of insurance notes payable outstanding | Stated Interest Original Balance at September 30, Maturity Date Rate Principal 2022 2021 Insurance Note Payable 2021 Insurance Note January 2022 4.99 % $ 391,625 $ — $ 148,385 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Leases | |
Schedule of ROU assets and lease liabilities | As of September 30, 2022 2021 Assets: Classification Operating lease right-of-use-asset Operating lease asset $ 5,614,698 $ 5,945,295 Financing lease right-of-use-asset Equipment, net 103,538 216,490 $ 5,718,236 $ 6,161,785 Liabilities: Current Classification Operating Operating lease liability $ 553,066 $ 382,576 Financing Financing lease liability 107,632 107,632 Long-term Operating Long-term portion of operating leases liability 5,335,164 5,794,096 Financing Long-term portion of financing leases liability — 109,500 $ 5,995,862 $ 6,393,804 |
Summary of quantitative information about the leases | Year Ended September 30, 2022 2021 Operating cash flows - operating leases $ 901,060 $ 128,963 Operating cash flows - financing leases 12,252 1,376 Financing cash flows - financing leases 109,500 8,770 Right-of-use asset obtained in exchange for operating lease liabilities $ 164,613 $ 6,117,772 Finance lease assets obtained in exchange for finance lease liabilities — 225,902 As of September 30, 2022 2021 Weighted-average remaining lease term – operating leases (in years) 8.74 9.83 Weighted-average discount rate – operating leases 7.3 % 7.3 % Weighted-average remaining lease term – financing leases (in years) 0.9 1.9 Weighted-average discount rate – financing leases 7.3 % 7.3 % The components of lease expense were as follows: Year Ended September 30, 2022 2021 Operating leases Operating lease cost $ 943,215 $ 360,340 Variable lease costs 2,400 18,216 Total operating lease cost 945,615 378,556 Short-term lease rent expense 40,719 113,158 Financing leases Amortization of leased assets 112,951 9,413 Interest on lease liabilities 12,252 1,376 Financing lease cost 125,203 10,789 Net lease cost $ 1,111,537 $ 502,503 |
Summary of future minimum lease payments under the non-cancelable operating lease | Operating Financing Leases Leases Year Ending September 30, 2023 $ 965,367 $ 111,606 Year Ending September 30, 2024 874,320 — Year Ending September 30, 2025 881,391 — Year Ending September 30, 2026 888,627 — Year Ending September 30, 2027 895,864 — Thereafter 3,505,166 — Total 8,010,735 111,606 Less present value discount (2,122,505) (3,974) Operating lease liabilities $ 5,888,230 $ 107,632 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Fair Value | |
Schedule of warrant liabilities were measured at fair value on a recurring basis | Fair Value Measurements as of September 30, 2022 (Level 1) (Level 2) (Level 3) Total Liabilities Warrant liabilities $ — — — $ — Fair Value Measurements as of September 30, 2021 (Level 1) (Level 2) (Level 3) Total Liabilities Warrant liabilities $ — — — $ — |
Schedule of assumptions were used in determining the fair value of the warrant liabilities | As of September 30, 2021 Remaining contractual term (years) 0.2 - 0.5 Common stock price volatility 60.6% - 62.5% Risk-free interest rate 0.04% Expected dividend yield — |
Schedule of change in fair value of the warrant liabilities | Fair value as of September 30, 2020 $ 950,151 Change in fair value (950,151) Fair value as of September 30, 2021 — Change in fair value — Fair value as of September 30, 2022 $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Schedule of warrants issued and outstanding | Expiration date Exercise Price Warrants Outstanding July 6, 2023 $ 8.73 105,000 September 20, 2024 6.50 75,000 180,000 Weighted- Weighted- Average Average Remaining Exercise Contractual Life Warrants Price (in years) Outstanding as of September 30, 2020 820,939 $ 19.44 Issued 75,000 6.50 Outstanding as of September 30, 2021 895,939 18.35 0.9 Expired (715,939) 21.01 Outstanding as of September 30, 2022 180,000 7.80 1.3 Exercisable as of September 30, 2022 180,000 7.80 1.3 |
Schedule of key assumptions used to estimate the fair value of the advisory warrants granted | As of September 30, 2021 Remaining contractual term (years) 3.0 Common stock price volatility 83.9 % Risk-free interest rate 0.5 % Expected dividend yield — |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Common Share | |
Schedule of anti dilutive securities excluded from the computation of diluted weighted average shares | The following potentially dilutive securities outstanding for the years ended September 30, 2022 and 2021 have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive: As of September 30, 2022 2021 Common stock purchase options 7,629,281 7,397,154 Restricted stock units — 10,000 Common stock purchase warrants 180,000 895,939 7,809,281 8,303,093 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Year Ended September 30, 2022 2021 General and administrative $ 1,817,797 $ 2,369,287 Research and development 1,079,892 1,327,097 Total $ 2,897,689 $ 3,696,384 |
Schedule of stock options issued and outstanding | Weighted- Weighted- Average Total Average Remaining Aggregate Exercise Contractual Intrinsic Stock Options Price Life (in years) Value Outstanding at September 30, 2020 6,190,790 $ 2.76 Granted 1,758,599 5.45 Exercised (47,052) 2.39 Forfeited (505,183) 6.80 Outstanding at September 30, 2021 7,397,154 3.13 Granted 1,768,365 2.14 Exercised (792,250) 0.00 Forfeited (743,988) 4.74 Outstanding at September 30, 2022 7,629,281 3.08 6.8 $ 992,754 Exercisable as of September 30, 2022 5,017,592 $ 2.90 5.7 $ 992,754 |
Schedule of key assumptions used to estimate the fair value of the stock options granted | Year Ended September 30, 2022 2021 Expected term of options (years) 5.1 - 6.1 6.1 Expected common stock price volatility 73.8% - 78.5% 82.7% - 83.7% Risk-free interest rate 1.1% - 3.4% 0.6% - 1.3% Expected dividend yield — — |
Schedule of the changes in the outstanding restricted stock | Weighted-Average Grant Date Unvested Restricted Fair Value Stock Price Unvested as of September 30, 2020 — $ — Granted 11,722 6.37 Vested (11,722) 6.37 Unvested as of September 30, 2021 — — Granted 4,441 3.94 Vested (4,441) 3.94 Unvested as of September 30, 2022 — — Total unrecognized expense remaining $ — Weighted-average years expected to be recognized over — |
Schedule of restricted stock units granted and outstanding | Weighted-Average Grant Date Restricted Stock Fair Value Units Price Unvested as of September 30, 2021 10,000 $ 5.09 Forfeited (10,000) 5.09 Unvested as of September 30, 2022 — — Total unrecognized expense remaining $ — Weighted-average years expected to be recognized over — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Schedule of components of the income tax benefits, net | For the Year Ended September 30, 2022 2021 Federal Current $ — $ — Deferred (6,780,606) (7,919,279) State and Local Current — — Deferred (2,746,540) (3,015,187) Change in valuation allowance 9,527,146 10,934,466 Income tax provision (benefit) $ — $ — |
Schedule of reconciliation of income taxes at the statutory federal income tax rate to net income taxes | For the Year Ended September 30, 2022 2021 U.S. federal income tax expense at the statutory rate (21.0) % (21.0) % State income taxes, net of federal taxes (7.7) (7.9) Stock-based compensation 1.0 1.2 Return to provision adjustment (0.5) (14.2) Other permanent items — (1.1) Change in valuation allowance 28.2 43.0 Income tax provision (benefit) — % — % |
Schedule of components of our deferred tax assets and liabilities | September 30, 2022 2021 Deferred tax assets Net operating loss carryforwards $ 22,461,508 $ 13,254,067 Stock-based compensation 4,072,264 3,779,555 Amortization 2,277,085 2,643,500 Service Warrant 180,276 147,168 Investment 263,073 141,098 Other 50,979 — Lease liability 1,715,159 66,982 Total deferred tax assets 31,020,344 20,032,370 Deferred tax liabilities Depreciation (158,317) (127,449) ROU assets (1,635,483) — Prepaid expenses — (205,523) Total deferred tax liabilities (1,793,800) (332,972) Valuation allowance (29,226,544) (19,699,398) Net deferred tax assets, net of allowances $ — $ — |
Organization, Description of _2
Organization, Description of Business and Liquidity (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Organization, Description of Business and Liquidity | ||
Cash and cash equivalents | $ 23,152,663 | $ 52,893,387 |
Loss from operations | (33,318,339) | $ (26,565,447) |
Private NeuBase | ||
Organization, Description of Business and Liquidity | ||
Cash and cash equivalents | 23,200,000 | |
Loss from operations | 33,300,000 | |
Net cash used in operating activities | $ 29,000,000 |
Significant Accounting Polici_3
Significant Accounting Policies - Additional Information (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Significant Accounting Policies | ||
Cash, FDIC Insured Amount | $ 250,000 | |
Impairment of goodwill | $ 0 | $ 0 |
Laboratory equipment | ||
Significant Accounting Policies | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Office equipment | ||
Significant Accounting Policies | ||
Property, Plant and Equipment, Useful Life | 3 years |
Significant Accounting Polici_4
Significant Accounting Policies - Marketable Securities (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Marketable Securities | ||
Marketable securities | $ 0 | $ 0 |
Asset Purchase Agreement (Detai
Asset Purchase Agreement (Details) - Vera transaction - USD ($) | Apr. 26, 2021 | Jan. 27, 2021 |
Asset Purchase Agreement | ||
Total consideration in cash | $ 796,124 | |
Number of shares issued as consideration | 308,635 | 308,635 |
Number of shares issued to Vera | 146,375 | |
Number of shares held in escrow | 162,260 |
Asset Purchase Agreement - Asse
Asset Purchase Agreement - Asset Acquisition (Details) - Vera transaction | Jan. 27, 2021 USD ($) |
Asset Purchase Agreement | |
Cash consideration | $ 796,124 |
Acquisition costs | 303,916 |
Fair value of common stock | 1,759,220 |
Total consideration | $ 2,859,260 |
Asset Purchase Agreement -Addit
Asset Purchase Agreement -Additional information (Details) - Vera transaction | Jan. 27, 2021 USD ($) |
Asset Purchase Agreement | |
Property, plant and equipment | $ 59,231 |
Other liabilities | (88,000) |
Fair value of net assets acquired | (28,769) |
Research and development expense | 2,888,029 |
Total cost of Vera acquisition | $ 2,859,260 |
Equipment (Details)
Equipment (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Equipment | ||
Property, plant and equipment, gross | $ 3,452,955 | $ 2,997,368 |
Accumulated depreciation and amortization | (1,296,104) | (533,486) |
Equipment, net | 2,156,851 | 2,463,882 |
Depreciation and amortization | 800,000 | 400,000 |
Laboratory equipment | ||
Equipment | ||
Property, plant and equipment, gross | $ 3,175,019 | 2,737,390 |
Estimated useful life | 5 years | |
Office equipment | ||
Equipment | ||
Property, plant and equipment, gross | $ 259,978 | $ 259,978 |
Estimated useful life | 3 years | |
Leasehold improvements | ||
Equipment | ||
Property, plant and equipment, gross | $ 17,958 | |
Estimated useful life | 5 years |
Other Prepaid Expenses and Ot_3
Other Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 | Nov. 30, 2020 |
Other Prepaid Expenses and Other Current Assets | |||
Prepaid research and development expense | $ 805,542 | $ 583,267 | |
Prepaid rent | 172,518 | $ 300,000 | |
Franchise tax receivable | 127,715 | ||
Other prepaid expenses and other current assets | 243,046 | 780,401 | |
Total | $ 1,176,303 | $ 1,536,186 |
Investment (Details)
Investment (Details) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Feb. 28, 2021 | |
Schedule of Equity Method Investments [Line Items] | |||
DepYmed preferred shares received in sale of intellectual property | $ 0 | $ 316,724 | |
Equity in loss | 400,000 | 200,000 | |
DepYmed | |||
Schedule of Equity Method Investments [Line Items] | |||
Percentage of ownership held | 15% | ||
Carrying value of DepYmed common shares | $ 0 | ||
Fair value of DepYmed preferred shares assumed in connection with acquisition of Ohr | 99,020 | ||
DepYmed preferred shares received in sale of intellectual property | 316,724 | ||
Total Investment | 415,744 | ||
DepYmed | Intellectual property | Other (expense) income, net | |||
Schedule of Equity Method Investments [Line Items] | |||
DepYmed preferred shares received in sale of intellectual property | $ 300,000 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Accrued Expenses and Other Current Liabilities | ||
Accrued compensation and benefits | $ 768,324 | $ 880,707 |
Accrued consulting settlement | 150,000 | 200,000 |
Accrued professional fees | 191,516 | 299,557 |
Accrued research and development | 512,570 | 297,047 |
Accrued franchise tax | 36,542 | 30,720 |
Other accrued expenses | 3,708 | 39,715 |
Total | $ 1,662,660 | $ 1,747,746 |
Notes Payable - Insurance notes
Notes Payable - Insurance notes payable outstanding (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Short-term Debt [Line Items] | ||
Outstanding balance | $ 0 | $ 148,385 |
2021 Insurance Note | ||
Short-term Debt [Line Items] | ||
Stated Interest Rate (as a percent) | 4.99% | |
Original Principal | $ 391,625 | |
Outstanding balance | $ 0 | $ 148,385 |
Leases - Additional Information
Leases - Additional Information (Detail) | 1 Months Ended | |||||
Nov. 30, 2020 USD ($) | Feb. 28, 2022 | Oct. 31, 2021 | Sep. 30, 2021 USD ($) | Aug. 31, 2021 | Oct. 31, 2020 ft² | |
Leases | ||||||
Term of operating lease agreement | 10 years | |||||
Square feet of office and laboratory space | ft² | 14,189 | |||||
Prepaid rent | $ 300,000 | $ 172,518 | ||||
Security deposit | $ 300,000 | |||||
Right to extend the term | true | |||||
Extension term of lease | 5 years | |||||
Term for finance lease | 18 months | 1 year | 2 years |
Leases - ROU assets and lease l
Leases - ROU assets and lease liabilities (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Assets: | ||
Operating lease right-of-use-asset | $ 5,614,698 | $ 5,945,295 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Operating lease right-of-use-asset | |
Financing lease right-of-use-asset | $ 103,538 | $ 216,490 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property, Plant and Equipment, Net | Property, Plant and Equipment, Net |
Assets total | $ 5,718,236 | $ 6,161,785 |
Current | ||
Operating | $ 553,066 | 382,576 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Operating | |
Financing | $ 107,632 | 107,632 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Financing | |
Long-term | ||
Operating | $ 5,335,164 | 5,794,096 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Operating | |
Financing | $ 0 | 109,500 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Financing | |
Liabilities total | $ 5,995,862 | $ 6,393,804 |
Leases - Quantitative Informati
Leases - Quantitative Information (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Leases | ||
Operating cash flows - operating leases | $ 901,060 | $ 128,963 |
Operating cash flows - financing leases | 12,252 | 1,376 |
Financing cash flows - financing leases | 109,500 | 8,770 |
Right-of-use asset obtained in exchange for operating lease liabilities | $ 164,613 | 6,117,772 |
Finance lease assets obtained in exchange for finance lease liabilities | $ 225,902 | |
Weighted-average remaining lease term - operating leases (in years) | 8 years 8 months 26 days | 9 years 9 months 29 days |
Weighted-average discount rate - operating leases | 7.30% | 7.30% |
Weighted-average remaining lease term - financing leases (in years) | 10 months 24 days | 1 year 10 months 24 days |
Weighted-average discount rate - financing leases | 7.30% | 7.30% |
Leases - Components of lease ex
Leases - Components of lease expense (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating leases | ||
Operating lease cost | $ 943,215 | $ 360,340 |
Variable lease costs | 2,400 | 18,216 |
Total operating lease cost | 945,615 | 378,556 |
Short-term lease rent expense | 40,719 | 113,158 |
Financing leases | ||
Amortization of leased assets | 112,951 | 9,413 |
Interest on lease liabilities | 12,252 | 1,376 |
Financing lease cost | 125,203 | 10,789 |
Net lease cost | $ 1,111,537 | $ 502,503 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) | Sep. 30, 2022 USD ($) |
Future minimum lease payments under the non-cancelable operating leases | |
Year Ending September 30, 2023 | $ 965,367 |
Year Ending September 30, 2024 | 874,320 |
Year Ending September 30, 2025 | 881,391 |
Year Ending September 30, 2026 | 888,627 |
Year Ending September 30, 2027 | 895,864 |
Thereafter | 3,505,166 |
Total | 8,010,735 |
Less present value discount | (2,122,505) |
Operating lease liabilities | 5,888,230 |
Financing Leases | |
Year Ended September 30, 2022 | 111,606 |
Total | 111,606 |
Less present value discount | (3,974) |
Finance lease liabilities | $ 107,632 |
Fair Value (Details)
Fair Value (Details) | 12 Months Ended |
Sep. 30, 2021 USD ($) Y | |
Liabilities | |
Warrant liabilities | $ 100,000 |
Change in fair value of the warrant liabilities | |
Fair value at the beginning | 950,151 |
Change in fair value | $ (950,151) |
Remaining contractual term (years) | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | Y | 3 |
Remaining contractual term (years) | Minimum [Member] | Estimate of Fair Value Measurement [Member] | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | 0.2 |
Remaining contractual term (years) | Maximum [Member] | Estimate of Fair Value Measurement [Member] | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | 0.5 |
Common stock price volatility | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | 83.9 |
Common stock price volatility | Minimum [Member] | Estimate of Fair Value Measurement [Member] | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | 60.6 |
Common stock price volatility | Maximum [Member] | Estimate of Fair Value Measurement [Member] | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | 62.5 |
Risk-free interest rate | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | 0.5 |
Risk-free interest rate | Estimate of Fair Value Measurement [Member] | |
Liabilities | |
Warrants and Rights Outstanding, Measurement Input | 0.04 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 12 Months Ended | ||
Apr. 26, 2021 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) Vote $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | |
Stockholders' Equity | |||
Preferred stock, authorized | 10,000,000 | 10,000,000 | |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |
Preferred stock, issued | 0 | 0 | |
Preferred stock, outstanding | 0 | 0 | |
Common stock, authorized | 250,000,000 | 250,000,000 | |
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |
Number of votes per share | Vote | 1 | ||
Common stock issued for cash (in shares) | 9,200,000 | ||
Additional stock issued to the underwriters | 1,200,000 | ||
Shares issued price per share | $ / shares | $ 5 | ||
Proceeds from issuance of stock, net of issuance costs | $ | $ 42,600,000 | $ 0 | $ 42,616,376 |
Warrants issued | 75,000 | ||
Warrants vesting period | 6 months | ||
Exercise price of warrants (in dollars per share) | $ / shares | $ 6.50 | ||
Warrants outstanding | $ | $ 100,000 | ||
Expiration term from issuance | 3 years | ||
Unrecognized compensation costs | $ | $ 0 | ||
Forfeited shares of common stock | 509,527 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants issued and outstanding (Details) - $ / shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Warrants [Roll Forward] | ||
Exercise price of warrants (in dollars per share) | $ 6.50 | |
Warrants, Outstanding at the beginning of the period | 895,939 | 820,939 |
Issued | 75,000 | |
Warrants, Expired | (715,939) | |
Warrants, Outstanding at the end of the period | 180,000 | 895,939 |
Warrants, Exercisable at the end of the period | 180,000 | |
Weighted-Average Exercise Price, Outstanding at the beginning of the period | $ 18.35 | $ 19.44 |
Weighted-Average Exercise Price, Expired | 21.01 | |
Weighted-Average Exercise Price, Outstanding at the end of the period | 7.80 | $ 18.35 |
Weighted-Average Exercise Price, Exercisable at the end of the period | $ 7.80 | |
Weighted-Average Remaining Contractual Life, Outstanding at the end of the period | 1 year 3 months 18 days | 10 months 24 days |
Weighted-Average Remaining Contractual Life, Exercisable at the end of the period | 1 year 3 months 18 days | |
Weighted average exercise price, Issued | $ 6.50 | |
July 6, 2023 | ||
Warrants [Roll Forward] | ||
Exercise price of warrants (in dollars per share) | $ 8.73 | |
Warrants, Outstanding at the end of the period | 105,000 | |
September 20, 2024 | ||
Warrants [Roll Forward] | ||
Exercise price of warrants (in dollars per share) | $ 6.50 | |
Warrants, Outstanding at the end of the period | 75,000 |
Stockholders' Equity - Fair val
Stockholders' Equity - Fair value of advisory warrants (Details) | Sep. 30, 2021 Y |
Remaining contractual term (years) | |
Stockholders' Equity | |
Warrants, measurement input | 3 |
Common stock price volatility | |
Stockholders' Equity | |
Warrants, measurement input | 83.9 |
Risk-free interest rate | |
Stockholders' Equity | |
Warrants, measurement input | 0.5 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Net Loss Per Common Share | ||
Antidilutive securities excluded from computation of net loss per common share | 7,809,281 | 8,303,093 |
Common stock purchase options | ||
Net Loss Per Common Share | ||
Antidilutive securities excluded from computation of net loss per common share | 7,629,281 | 7,397,154 |
Restricted stock units | ||
Net Loss Per Common Share | ||
Antidilutive securities excluded from computation of net loss per common share | 10,000 | |
Common stock purchase warrants | ||
Net Loss Per Common Share | ||
Antidilutive securities excluded from computation of net loss per common share | 180,000 | 895,939 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-based compensation expense (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-Based Compensation expense | ||
Total stock based compensation | $ 2,897,689 | $ 3,696,384 |
General and administrative | ||
Stock-Based Compensation expense | ||
Total stock based compensation | 1,817,797 | 2,369,287 |
Research and development | ||
Stock-Based Compensation expense | ||
Total stock based compensation | $ 1,079,892 | $ 1,327,097 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock options (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock Options | ||
Outstanding, Beginning balance | 7,397,154 | 6,190,790 |
Granted | 1,768,365 | 1,758,599 |
Exercised | (792,250) | (47,052) |
Forfeited | (743,988) | (505,183) |
Outstanding, Ending balance | 7,629,281 | 7,397,154 |
Exercisable | 5,017,592 | |
Weighted-Average Exercise Price per Share | ||
Outstanding, Beginning balance | $ 3.13 | $ 2.76 |
Granted | 2.14 | 5.45 |
Exercised | 0 | 2.39 |
Forfeited | 4.74 | 6.80 |
Outstanding, Ending balance | 3.08 | $ 3.13 |
Exercisable | $ 2.90 | |
Weighted-Average Remaining Contractual Life (in years) and Aggregate Intrinsic Value | ||
Outstanding | 6 years 9 months 18 days | |
Exercisable | 5 years 8 months 12 days | |
Outstanding | $ 992,754 | |
Exercisable | $ 992,754 |
Stock-Based Compensation - Key
Stock-Based Compensation - Key assumptions used to estimate the fair value of the stock options granted (Details) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Key assumptions used to estimate the fair value of the stock options granted | ||
Expected term of options (years) | 6 years 1 month 6 days | |
Expected common stock price volatility, minimum | 73.80% | 82.70% |
Expected common stock price volatility, maximum | 78.50% | 83.70% |
Risk-free interest rate, minimum | 1.10% | 0.60% |
Risk-free interest rate, maximum | 3.40% | 1.30% |
Expected dividend yield | 0% | 0% |
Minimum | ||
Key assumptions used to estimate the fair value of the stock options granted | ||
Expected term of options (years) | 5 years 1 month 6 days | |
Maximum | ||
Key assumptions used to estimate the fair value of the stock options granted | ||
Expected term of options (years) | 6 years 1 month 6 days |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock And Restricted Stock Units (Details) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Restricted Stock Units | |||
Total unrecognized expense remaining | $ 0 | ||
Weighted-average years expected to be recognized over | 1 year 4 months 24 days | ||
Unvested restricted stock | |||
Restricted Stock Units | |||
Unvested, Beginning balance | 0 | 0 | |
Granted | 4,441 | 11,722 | |
Vested | 4,441 | 11,722 | |
Unvested, Ending balance | 0 | 0 | |
Total unrecognized expense remaining | $ 0 | ||
Weighted-average years expected to be recognized over | 0 years | ||
Weighted-Average Grant Date Fair Value Price | |||
Unvested, Beginning balance | $ 0 | $ 0 | $ 0 |
Granted | 3.94 | 6.37 | |
Vested | 3.94 | 6.37 | |
Unvested, Ending balance | $ 0 | $ 0 | $ 0 |
Restricted stock units | |||
Restricted Stock Units | |||
Unvested, Beginning balance | 10,000 | ||
Forfeited | (10,000) | ||
Unvested, Ending balance | 10,000 | ||
Weighted-average years expected to be recognized over | 0 years | ||
Weighted-Average Grant Date Fair Value Price | |||
Unvested, Beginning balance | $ 5.09 | ||
Forfeited | $ 5.09 | ||
Unvested, Ending balance | $ 5.09 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-Based Compensation | ||
Unrecognized compensation costs | $ 2,500 | |
Weighted-average amortization period | 1 year 4 months 24 days | |
Intrinsic value of stock options exercised | $ 400 | $ 200 |
Weighted average grant date fair value of option granted | $ 1.40 | $ 3.84 |
Stock options granted to consultant for future services | 225,000 | |
Unvested restricted stock | ||
Stock-Based Compensation | ||
Weighted-average amortization period | 0 years | |
Fair value of restricted stock vested | $ 20 | $ 100 |
2016 Plan | ||
Stock-Based Compensation | ||
Number of common stock authorized | 291,667 | |
Common shares were available for future grants | 147,041 | |
2019 Plan | ||
Stock-Based Compensation | ||
Number of common stock authorized | 6,018,136 | |
Common shares were available for future grants | 697,893 | |
Minimum | ||
Stock-Based Compensation | ||
Vesting period (in years) | 1 year | |
Maximum | ||
Stock-Based Compensation | ||
Vesting period (in years) | 4 years | |
Expiration period (in years) | 10 years |
Income Taxes - Components of in
Income Taxes - Components of income tax benefits, net (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Federal | ||
Deferred | $ (6,780,606) | $ (7,919,279) |
State and Local | ||
Deferred | (2,746,540) | (3,015,187) |
Change in valuation allowance | $ 9,527,146 | $ 10,934,466 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of income taxes (Details) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Reconciliation of income taxes at the statutory federal income tax rate to net income taxes | ||
U.S. federal income tax expense at the statutory rate | (21.00%) | (21.00%) |
State income taxes, net of federal taxes | (7.70%) | (7.90%) |
Stock-based compensation | 1% | 1.20% |
Return to provision adjustment | (0.50%) | (14.20%) |
Other permanent items | (1.10%) | |
Change in valuation allowance | 28.20% | 43% |
Income tax provision (benefit) | 0% |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets and liabilities (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Deferred tax assets | ||
Net operating loss carryforwards | $ 22,461,508 | $ 13,254,067 |
Stock-based compensation | 4,072,264 | 3,779,555 |
Amortization | 2,277,085 | 2,643,500 |
Service Warrant | 180,276 | 147,168 |
Investment | 263,073 | 141,098 |
Other | 50,979 | |
Lease liability | 1,715,159 | 66,982 |
Total deferred tax assets | 31,020,344 | 20,032,370 |
Deferred tax liabilities | ||
Depreciation | (158,317) | (127,449) |
ROU assets | (1,635,483) | |
Prepaid expenses | (205,523) | |
Total deferred tax liabilities | (1,793,800) | (332,972) |
Valuation allowance | $ (29,226,544) | $ (19,699,398) |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) | 12 Months Ended |
Sep. 30, 2022 USD ($) | |
Income Taxes | |
Effective tax rate | 0% |
Income tax related interest or penalties assessed or recorded | $ 0 |
Uncertain tax positions | 0 |
Federal | |
Income Taxes | |
Operating loss carryforwards | 77,100,000 |
State | |
Income Taxes | |
Operating loss carryforwards | $ 77,100,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies. | ||
Employee match contribution | $ 134,927 | $ 14,158 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event $ in Millions | 1 Months Ended |
Oct. 31, 2022 USD ($) | |
Subsequent Event | |
Restructuring Costs | $ 0.5 |
Cross-functional reduction of workforce (in percent) | 60% |