Going Concern and Management’s Plans	6 Months Ended
Jun. 30, 2023
Going Concern and Management’s Plans [Abstract]
Going Concern and Management’s Plans	Note 2 — Going Concern and Management’s Plans The Company’s operating activities to date have been devoted to seeking licenses and engaging in research and development activities. The Company’s product candidates currently under development will require significant additional research and development efforts prior to commercialization. The Company has financed its operations since inception primarily using proceeds received from seed investors, and proceeds received from its IPO and private placement issuances in April and August 2022 (the “Private Placements”, see Note 8). During 2022, the Company completed its IPO and the Private Placements in which the Company received an aggregate of approximately $33.1 million in net cash proceeds, after deducting placement agent fees and other offering expenses. The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of June 30, 2023, the Company had cash of approximately $9.2 million, a working capital deficit of approximately $0.7 million and an accumulated deficit of approximately $29.1 million. During April 2023, the Company completed an acquisition of assets that requires the Company to pay initial consideration of $20.0 million, of which $6.0 million was paid upon close and $9.0 million of the remainder was originally due to the seller of the assets within one year of the date these condensed financial statements were issued. The remaining $5.0 million is due in September 2024. On September 29, 2023, the Company entered into an amendment to this agreement (the “Veru APA Amendment”). Pursuant to the Veru APA Amendment, the $4.0 million note payable originally due on September 30, 2023, was deemed paid and fully satisfied upon (1) the payment to the seller of the assets of $1 million on September 29, 2023, and (2) the issuance to the seller of the assets by October 3, 2023, of 3,000 shares of Series A Convertible Preferred Stock of the Company. The Company made such $1 million payment on September 29, 2023 and issued the Series A Preferred Stock on October 3, 2023. (See Notes 5 and 15.) During June 2023, the Company also executed an asset purchase agreement, whereby the Company transferred $3.5 million of cash consideration for the acquisition of a business, for which closing is contingent on certain conditions. The Company will be required to transfer $4.5 million in additional cash consideration if the transaction closes. However, on September 26, 2023, WraSer filed for bankruptcy under Chapter 11 of the U.S. Bankruptcy Code, and on October 6, 2023, the Company was alerted to certain issues in WraSer’s operations that the Company believes constitutes a Material Adverse Effect (as such term is defined in the WraSer APA) that will prevent the Company from closing the transaction. These circumstances create substantial uncertainty, should the acquisition not close, that the Company will be able to recover the initial $3.5 million payment, and therefore the Company wrote off the balance of the advance payment as of June 30, 2023 (see Notes 5 and 15). These factors, along with the Company’s forecasted future cash flows, indicate that the Company will be unable to meet its contractual commitments and obligations as they come due in the ordinary course of business within one year following the issuance of these condensed financial statements. The Company will require significant additional capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due for the acquisition of assets described above and other contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support the Company’s working capital needs and business activities. These include the commercialization of ENTADFI®, and the development and commercialization of the Company’s current product candidates and future product candidates. Management’s plans include generating product revenue from sales of ENTADFI®, which has not yet been successfully commercialized, a process that will require significant amounts of additional capital to complete. In addition, certain of the commercialization activities are outside of the Company’s control, including but not limited to, securing contracts with wholesalers and third party payers, securing contracts with third-party logistics providers, obtaining required licensure in various jurisdictions, and building a salesforce, as well as attempting to secure additional required funding through equity or debt financings if available; however, there are currently no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all, which creates significant uncertainty that the Company will be able to successfully launch ENTADFI®. If the Company is unable to secure additional capital, it may be required to curtail any clinical trials, development and/or commercialization of products and product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. Because of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the condensed financial statements, which is not alleviated by management’s plans. The condensed financial statements have been prepared assuming the Company will continue as a going concern. These condensed financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

Going Concern and Management’s Plans

6 Months Ended

Jun. 30, 2023

Going Concern and Management’s Plans [Abstract]

Note 2 — Going Concern and Management’s Plans

The Company’s operating activities to date have been devoted to seeking licenses and engaging in research and development activities. The Company’s product candidates currently under development will require significant additional research and development efforts prior to commercialization. The Company has financed its operations since inception primarily using proceeds received from seed investors, and proceeds received from its IPO and private placement issuances in April and August 2022 (the “Private Placements”, see Note 8). During 2022, the Company completed its IPO and the Private Placements in which the Company received an aggregate of approximately $33.1 million in net cash proceeds, after deducting placement agent fees and other offering expenses.

The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of June 30, 2023, the Company had cash of approximately $9.2 million, a working capital deficit of approximately $0.7 million and an accumulated deficit of approximately $29.1 million. During April 2023, the Company completed an acquisition of assets that requires the Company to pay initial consideration of $20.0 million, of which $6.0 million was paid upon close and $9.0 million of the remainder was originally due to the seller of the assets within one year of the date these condensed financial statements were issued. The remaining $5.0 million is due in September 2024. On September 29, 2023, the Company entered into an amendment to this agreement (the “Veru APA Amendment”). Pursuant to the Veru APA Amendment, the $4.0 million note payable originally due on September 30, 2023, was deemed paid and fully satisfied upon (1) the payment to the seller of the assets of $1 million on September 29, 2023, and (2) the issuance to the seller of the assets by October 3, 2023, of 3,000 shares of Series A Convertible Preferred Stock of the Company. The Company made such $1 million payment on September 29, 2023 and issued the Series A Preferred Stock on October 3, 2023. (See Notes 5 and 15.) During June 2023, the Company also executed an asset purchase agreement, whereby the Company transferred $3.5 million of cash consideration for the acquisition of a business, for which closing is contingent on certain conditions. The Company will be required to transfer $4.5 million in additional cash consideration if the transaction closes. However, on September 26, 2023, WraSer filed for bankruptcy under Chapter 11 of the U.S. Bankruptcy Code, and on October 6, 2023, the Company was alerted to certain issues in WraSer’s operations that the Company believes constitutes a Material Adverse Effect (as such term is defined in the WraSer APA) that will prevent the Company from closing the transaction. These circumstances create substantial uncertainty, should the acquisition not close, that the Company will be able to recover the initial $3.5 million payment, and therefore the Company wrote off the balance of the advance payment as of June 30, 2023 (see Notes 5 and 15).

These factors, along with the Company’s forecasted future cash flows, indicate that the Company will be unable to meet its contractual commitments and obligations as they come due in the ordinary course of business within one year following the issuance of these condensed financial statements. The Company will require significant additional capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due for the acquisition of assets described above and other contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support the Company’s working capital needs and business activities. These include the commercialization of ENTADFI®, and the development and commercialization of the Company’s current product candidates and future product candidates. Management’s plans include generating product revenue from sales of ENTADFI®, which has not yet been successfully commercialized, a process that will require significant amounts of additional capital to complete. In addition, certain of the commercialization activities are outside of the Company’s control, including but not limited to, securing contracts with wholesalers and third party payers, securing contracts with third-party logistics providers, obtaining required licensure in various jurisdictions, and building a salesforce, as well as attempting to secure additional required funding through equity or debt financings if available; however, there are currently no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all, which creates significant uncertainty that the Company will be able to successfully launch ENTADFI®. If the Company is unable to secure additional capital, it may be required to curtail any clinical trials, development and/or commercialization of products and product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations.

Because of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the condensed financial statements, which is not alleviated by management’s plans. The condensed financial statements have been prepared assuming the Company will continue as a going concern. These condensed financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.