Commitments and Contingencies | Note 7 - Commitments and Contingencies Commitments and contingencies are described below and summarized by the following table: Total (1) 2020 2021 2022 2023 2024 Thereafter Key clinical research trial obligations $ 2,915,000 $ 675,000 $ 2,240,000 $ — $ — $ — $ — BLA consulting services 1,143,000 — 457,000 686,000 — — — Statistical analysis and programming consulting services 318,000 30,000 288,000 — — — — Employment agreements 1,478,000 216,000 783,000 466,000 13,000 — — Commercial insurance premium financing agreement 721,000 474,000 247,000 — — — — $ 6,575,000 $ 1,395,000 $ 4,015,000 $ 1,152,000 $ 13,000 $ — $ — (1) Not included in the commitments and contingencies table above are the monthly principal and interest payments of $23,000 that would be due beginning in August 2021 under the PPP loan if it is not forgiven by the SBA (see Note 6 ). Key Clinical Research Trial Obligations AP-013 study In March 2019, the Company entered into a contract with a CRO in connection with the AP-013 study totaling $6.2 million and covering an initial clinical trial size of 724 patients, which was increased by $4.1 million in January 2020 as a result of an increase in the number of participating patients to 1,034, resulting in the CRO contract commitment totaling $10.3 million. In April 2020, and pursuant to the FDA guidance covering ongoing clinical trials in the presence of the COVID-19 pandemic, the Company and the CRO paused all ongoing conduct associated with the AP-013 study. Increases in COVID-19 cases across certain regions of the United States continue to be reported on a consistent basis. Due to the continued increase in reported cases, the Company has determined that the AP-013 study will remain paused. However, the FDA recently provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic. The Company is reviewing this guidance and continues to have ongoing discussions with the CRO to determine the best approach for the AP-013 study. From the inception of this contract through September 30, 2020, the Company incurred and accrued cumulative costs totaling $8.2 million against the contract. This contract had an outstanding obligation for future costs and services totaling $2.1 million as of September 30, 2020. However, this obligation assumes that the Company will continue the AP-013 study at the same point the study was paused, and that the completion of the study will be consistent with the parameters as contained in the existing contract, which may not be the case. The Company continues to explore all viable options to enable it to complete the AP-013 study; however, it is possible that the COVID-19 pandemic may prevent completion of the AP-013 study at this time or at all. Due to the uncertainty resulting from the COVID-19 pandemic, the future contractual commitment amount related to the AP-013 study may change. The following table provides further detail of the Company’s current contractual obligations for the conduct of the AP-013 study, which does not reflect any changes related to the potential impact of COVID-19, as such impacts are unknown and cannot be reasonably estimated at the date of this filing: September 30, 2020 Original contract (based on 724 patients) $ 6,180,000 Amendment to contract (based on 1,034 patients) 4,075,000 Total contract $ 10,255,000 Initial deposit (included in original contract amount) $ 861,000 Amendment to deposit 699,000 Expenses incurred applied to deposit (1,386,000) Remaining deposit (applied to future expenses) $ 174,000 Expenses incurred/accrued (includes expenses applied to deposit) $ 8,182,000 Total future commitment $ 2,073,000 Inhaled treatment for COVID-19 patients In May 2020, the Company entered into a contract with a CRO in connection with a pre-clinical inhaled safety study for Ampion totaling $207,000. In August 2020, the Company finalized contract negotiations to increase the contract to $250,000 as a result of additional pre-study work and reporting. In September 2020, the safety study was completed and, as such, the Company had no outstanding future commitment as of September 30, 2020. The data from the safety study was submitted to the FDA to support the Investigational New Drug (“IND”) application covering inhaled Ampion treatment for COVID-19 patients, which was granted in September 2020. In September 2020, the Company entered into a contract with a CRO in connection with the FDA approved IND application covering inhaled Ampion treatment for COVID-19 infected patients hospitalized for respiratory distress (the “AP-014 study”) totaling $836,000. The Company expects to commence the AP-014 study during the fourth quarter of fiscal 2020 and, as such, had an outstanding future commitment of $836,000 as of September 30, 2020. In October 2020, the Company entered into a contract with a regional hospital group in connection with the FDA approved IND application for the AP-014 study totaling $30,000. As noted above, the Company expects to commence the AP-014 study during the fourth quarter of fiscal 2020. Intravenous (“IV”) treatment for COVID-19 patients In June 2020, the Company entered into a contract with a CRO in connection with the FDA approved IND application covering IV Ampion treatment for COVID-19 patients (the “AP-016 study”) totaling $43,000. In September 2020, the AP-016 study was completed. However, the Company will continue to monitor the patients enrolled in the AP-016 study for a 90-day period subsequent to the completion of the study and costs are expected to be minimal during this period. In July 2020, the Company entered into a contract with a regional hospital group in connection with the FDA approved IND application for the AP-016 study totaling $50,000. As noted above, the Company completed the AP-016 study in September 2020 and, as such, had no outstanding future commitment as of September 30, 2020. BLA Consulting Services In March 2018, the Company entered into a BLA consulting services agreement for $1.2 million. This contract required a deposit, of which $182,000 was funded and recorded within the “prepaid expenses and other” line item on the balance sheet. In June 2020, the Company finalized contract negotiations to increase the contract by a nominal amount to incorporate the review of the IND applications for inhaled and IV Ampion treatment. In September 2020, the Company finalized contract negotiations to provide a refund of the deposit totaling $182,000 due to the pause of the AP-013 study and the delay in filing of the BLA. The Company is required to provide a deposit totaling $364,000 once the work commences related to the preparation of the related BLA for Ampion. The Company had incurred cumulative costs totaling $79,000 against this contract and, as such, had outstanding future obligations totaling $1.1 million as of September 30, 2020, which will be settled at such time future services are provided to the Company primarily related to the development and filing of the Ampion BLA. Given the uncertainty surrounding the COVID-19 pandemic and the resulting impact on the AP-013 study, at the date of this filing, the Company estimates the incurrence of the remaining costs associated with the preparation of the BLA filing will be postponed until late fiscal 2021, if not later. Statistical Analysis and Programming Consulting Services In May 2019, Ampio entered into a statistical analysis and programming consulting services agreement for $578,000. As of September 30, 2020, the Company had incurred cumulative costs totaling $260,000 against the contract and, as such, had an outstanding obligation of $318,000. Employment Agreements On December 14, 2019, the Company entered into a new 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 new 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 new two-year employment agreement with Ms. Cherevka, Chief Operating Officer, which by its terms cancelled the previous employment agreement on such date. The new employment agreement provides for an annual salary of $280,000 and a term ending September 16, 2021, subject to certain automatic renewal provisions. 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. The employment agreement, as amended in July 2020, allowed for reimbursement of reasonable commuting and relocation expenses, including the employee portion of taxes, for up to one year. The commuting and relocation expenses were substantially incurred as of September 30, 2020 with the residual expected to be incurred during the fourth quarter of fiscal 2020. 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 July 2020, the Company entered into an insurance premium financing agreement for $1.0 million, with a term of nine months and an annual interest rate of 3.37%. Under the terms and provisions of the agreement, the Company will be required to make principal and interest payments totaling $116,000 per month over the remaining term of the agreement. The outstanding obligation as of September 30, 2020 was $683,000, which will be paid in full by March 2021. In addition, as of September 30, 2020, the Company had a remaining balance of $38,000 related to annual insurance premiums payable to the Company’s insurance broker, which will be paid in full by June 2021. Facility Lease In December 2013, the Company entered into a 125-month non-cancellable operating lease for office space and a manufacturing facility. The effective date of the lease was May 1, 2014. The initial base rent of the lease was $23,000 per month. The total base rent over the term of the lease is approximately $3.3 million, which includes rent abatements and leasehold incentives. The Company adopted the FASB issued ASC 842, “Leases (Topic 842)” lease term and the lease obligation represents the Company’s commitment to make the lease payments arising from the lease. ROU lease assets and obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term. As the Company’s lease does not provide an implicit rate, the Company used an estimated incremental borrowing rate 5.75% based on the information available at the commencement date in 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 as current or long-term on the balance sheet. 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 presented in the balance sheet as of September 30, 2020: Facility Lease Payments Remainder of 2021 2022 2023 2024 Thereafter Remaining Facility Lease Payments $ 1,429,000 $ 85,000 $ 345,000 $ 355,000 $ 364,000 $ 280,000 $ — Less: Discount Adjustment (152,000) Total lease liability $ 1,277,000 Lease liability-current portion $ 278,000 Long-term lease liability $ 999,000 The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of September 30, 2020: ROU Asset Balance as of December 31, 2019 $ 1,003,000 Amortization (133,000) Balance as of September 30, 2020 $ 870,000 The Company recorded lease expense in the respective periods is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Lease expense $ 66,000 $ 65,000 $ 198,000 $ 196,000 |