Commitments and Contingencies | Note 7 - Commitments and Contingencies Commitments and contingencies are described below and summarized by the following table: Total 2021 2022 2023 2024 2025 Thereafter Key clinical research trial obligations $ 3,896,000 $ 2,768,000 $ 1,128,000 $ — $ — $ — $ — Employment agreements 830,000 351,000 466,000 13,000 — — — Commercial insurance premium financing agreement 808,000 539,000 269,000 — — — — Statistical analysis and programming consulting services 326,000 163,000 163,000 — — — — $ 5,860,000 $ 3,821,000 $ 2,026,000 $ 13,000 $ — $ — $ — Key Clinical Research Trial Obligations Osteoarthritis of the Knee AP-013 study In December 2020, the Company entered into an initial contract with a CRO in reference to the AP-013 study database totaling $1.4 million. The contractual provisions required a retainer of $315,000, which will be applied to future study expenses as further defined by the contract. In the event of premature termination, the Company will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer. In March 2021, the Company submitted a detailed proposal to the FDA in response to the FDA’s guidance regarding the status of the AP-013 study, which was paused as a result of the COVID-19 pandemic. In April 2021, the Company received a response to the proposal from the FDA. In May 2021, the FDA issued updated statistical guidance for the industry. At this time, the Company is evaluating its options to analyze the clinical trial data from the AP-013 study. The Company had an outstanding future contractual commitment of $382,000 (net of deposit) as of June 30, 2021. Inhaled treatment for COVID-19 patients AP-018 study and AP-019 study In March 2021, the Company entered into a contract with a CRO totaling $318,000 in reference to a Phase I study for at-home treatment utilizing inhaled Ampion to treat patients with Post-Acute Sequelae of SARS-CoV-2 infection (“PASC”) commonly referred to as “Long-COVID”, or prolonged respiratory symptoms due to COVID-19 (the “AP-018 study”). The contractual provisions required an initial retainer of $105,000, which will be applied to future study expenses as further defined by the contract. In the event of premature termination, the Company will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer. The Company had an outstanding future contractual commitment of $130,000 (net of deposit) as of June 30, 2021. In June 2021, the Company entered into a contract with a CRO totaling $2.5 million in reference to a multicenter Phase II clinical trial, using inhaled Ampion in the treatment of respiratory distress due to COVID-19 (the “AP-019 study”). The contractual provisions required an initial retainer of $300,000, which will be applied to future study expenses as further defined by the contract. In the event of premature termination, the Company will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer. The Company had an outstanding future contractual commitment of $2.2 million (net of deposit) as of June 30, 2021. Intravenous (“IV”) treatment for COVID-19 patients AP-017 study In December 2020, the Company entered into a contract with a CRO totaling $1.8 million in reference to a multicenter Phase II clinical trial utilizing IV Ampion in the treatment of patients suffering from complications arising from COVID- 19 (the AP-017 study”). The contractual provisions required a retainer of $345,000, which will be applied to future study expenses as further defined by the contract. The contract currently accounts for 120 patients; however, based on the revised protocol, the number of patients has increased to 200. The Company is in ongoing discussions with the CRO to amend the contractual amount to account for the additional patients expected to be enrolled. In the event of premature termination, the Company will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer. Employment Agreements On December 14, 2019, the Company entered into a three-year employment agreement with Mr. Macaluso, Chief Executive Officer, which became effective January 10, 2020, immediately following the expiration of his prior employment agreement. The employment agreement provides for an annual salary of $300,000 and term ending January 10, 2023, subject to certain automatic renewal provisions. On September 16, 2019, the Company entered into a The Company entered into an employment agreement with Mr. Daniel Stokely, Chief Financial Officer, on July 9, 2019, which provided for an annual salary of $285,000 and a term beginning July 31, 2019 and lasting for three years, subject to certain automatic renewal provisions. Amounts noted above do not assume the continuation of employment beyond the contractual terms of each employee’s existing employment agreements. Commercial Insurance Premium Financing Agreement In June 2021, the Company entered into an insurance premium financing agreement for $0.9 million, with a term of nine months and an annual interest rate of 3.57%. Under the terms and provisions of the agreement, the Company will be required to make principal and interest payments totaling $82,000 per month over the remaining term of the agreement. The outstanding obligation as of June 30, 2021 was $734,000, which will be paid in full by March 2022. In addition, as of June 30, 2021, the Company had a remaining balance of $74,000 related to annual insurance premiums payable to the Company’s insurance broker, which will be paid in full by March 2022. Statistical Analysis and Programming Consulting Services In May 2019, the Company entered into a statistical analysis and programming consulting services agreement for $578,000. As of June 30, 2021, the Company had incurred cumulative costs totaling $252,000 against the contract and, as such, had an outstanding obligation of $326,000, which is expected to be settled by fiscal 2022. Facility Lease In December 2013, the Company entered into a 125-month “Leases (Topic 842)” determining the present value of the lease payments. Lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. The lease liability is classified both as current in part and long-term in part on the balance sheet based on the projected settlement of the liability. The following table provides a reconciliation of the Company’s remaining undiscounted payments for its facility lease and the carrying amount of the lease liability disclosed on the balance sheet as of June 30, 2021: Facility Lease Payments Remainder of 2022 2023 2024 2025 Thereafter Remaining Facility Lease Payments $ 1,173,000 $ 174,000 $ 355,000 $ 364,000 $ 280,000 $ — $ — Less: Discount Adjustment (102,000) Total lease liability $ 1,071,000 Lease liability-current portion $ 298,000 Long-term lease liability $ 773,000 The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of June 30, 2021: ROU Asset Balance as of December 31, 2020 $ 824,000 Amortization (96,000) Balance as of June 30, 2021 $ 728,000 The Company recorded lease expense in the respective periods is as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Lease expense $ 67,000 $ 66,000 $ 140,000 $ 132,000 |