Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing elsewhere in this report. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business and related financings, includes forward-looking statements that involve risks and uncertainties. You should read the “Risk Factors” section of this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Critical Accounting Policies, Estimates and Judgments
Our financial statements were prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses incurred during the reporting period. On an on-going basis, management evaluates its estimates and judgments. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable and appropriate under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The methods, estimates, and judgments used by us in applying these critical accounting policies have a significant impact on the results we report in our financial statements. Additional information regarding our critical accounting policies and estimates is contained in Notes 2, 6, 8 and 10 to the Financial Statements. We consider the following accounting estimates to be those that are most important to the portrayal of our financial condition and that require a higher degree of judgment.
Insurance Recovery Receivable
We reached the retention limit of $2.5 million under our D&O insurance policy during the second quarter of 2023 related to the SEC investigation and class action and derivative lawsuits, which were initiated during the second half of 2022 and continued through the 2023 period. As such, we estimate the percentage of legal invoices that will be reimbursed by the insurance carrier to determine the proper amount to record for the insurance recovery receivable, which offsets the legal fees incurred. The insurance recovery receivable estimate is based off previous insurance reimbursement. During the 2023 period, the average insurance recovery of legal fees was approximately 98% of legal fees incurred. Although we do not expect our estimates to be materially different from the amounts actually received, our understanding of the insurance carriers review and reimbursement process may vary and may result in the reporting of amounts that are too high or too low for any particular period. To date, there have not been any material adjustments to our prior estimates of the insurance recovery receivable.
Recent Accounting Pronouncements
Information regarding recently issued and relevant accounting standards (adopted and not adopted as of December 31, 2023) is contained in Note 2 to the Financial Statements.
Results of Operations—Year Ended December 31, 2023 Compared to December 31, 2022
We recognized a net loss for the year ended December 31, 2023 (the “2023 period”) of $8.6 million compared to the net loss recognized of $16.3 million for the year ended December 31, 2022 (the “2022 period”). The net loss during the 2023 period was primarily attributable to operating expenses of $9.6 million; partially offset by interest income and rental income of $0.3 million and $0.3 million, respectively, in addition to a non-cash gain from the elimination of an asset retirement obligation (“ARO”) of $0.3 million. The net loss during the 2022 period was primarily attributable to operating expenses of $22.3 million, which included a $1.9 million impairment loss related to long-lived and ROU assets; partially offset by the non-cash derivative gain and interest income of $5.8 million and $0.2 million, respectively. Operating expenses decreased $12.7 million, or 57%, from the 2022 period to the 2023 period primarily due to a (i) $6.5 million, or 73% decrease in research and development costs, (ii) $4.4 million, or 38%, decrease in general and
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administrative costs, (iii) and no recognition of impairment loss associated with the Company’s long-lived and ROU assets, which totaled $1.9 million during the 2022 period.
Research and Development
Research and development costs decreased by approximately $6.5 million, or 73%, for the 2023 period compared to the 2022 period. Research and development costs with variances above $175,000 and 10% are further explained below.
Years Ended December 31,
Professional fees
Operations/manufacturing
Laboratory
Salaries and benefits
Depreciation
Clinical trial and sponsored research expenses
Other
Share-based compensation
Total research and development
Professional Fees
Professional fees expense increased $36,000, or 5%, from 2022 to 2023. The increase is attributable primarily to costs we incurred during the 2023 period related to contractor fees for drug development and related advisory services for the OA-201 development program as part of our human capital resources strategy; partially offset by costs incurred related to a contracted Chief Medical Officer services required during the 2022 period, to assist with the final closeout of the Ampion clinical trials.
Operations/Manufacturing
Operations/manufacturing expenses increased $0.5 million, or 161%, from 2022 to 2023 as a result of the CDMO agreement, which was executed during the third quarter of 2023 and the completion of the OA-201 development milestones through the end of the 2023 period. This increase is partially offset by the shut-down and discontinued use/support of the cleanroom and overall manufacturing facility which completed in the second half 2022.
Laboratory
Laboratory operations/manufacturing expenses decreased $0.5 million, or 57%, from 2022 to 2023 as a result of the shift to outsourced non-clinical lab work related to the continued development of OA-201, which commenced during the first quarter of 2023. During the 2022 period we conducted laboratory operations to support the AP-017 and AP-019 clinical trials, combined with outsourced services to support the development of AR-300. This decrease is partially offset by the non-clinical trials conducted with research institutions for the OA-201 program during the fourth quarter of 2023, which is included in the Professional Fees line item above. In February and March 2024, we terminated agreements with research institutions relating to the non-clinical studies.
Salaries and benefits
Salaries and benefits expenses decreased $2.4 million, or 88%, from 2022 to 2023 as a result of the reduction in force (“RIF”) which was implemented in third quarter 2022 and completed in early first quarter 2023, which resulted in a 78% reduction of our workforce and the termination of a certain officer.
Depreciation
Depreciation expense decreased by $0.9 million, or 88%, from 2022 to 2023 as a result of (i) the initial impairment of our long-lived assets in third quarter 2022, with a final adjustment in March 2023, as a result of the sublease of the Ampio’s premises and (ii) a sale of all existing personal property to the subtenant in conjunction with the provisions of the sublease agreement.
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Clinical trial and sponsored research expenses
The clinical trial and sponsored research expenses decreased by approximately $3.0 million, or 100%, from 2022 to 2023 primarily due to the close-out efforts relating to the AP-017 and AP-019 studies reflecting costs totaling $2.3 million during the 2022 period. In addition, we incurred $0.7 million during the 2022 period related to the final close-out of the AP-013 clinical trial. The Company was not engaged in any clinical trials during the 2023 period.
General and Administrative
General and administrative expenses decreased $4.4 million, or 38%, for the 2023 period compared to the 2022 period. General and administrative costs with variances above $175,000 and 10% are further explained below.
Year Ended December 31,
Professional fees
Salaries and benefits
Insurance
Director fees
Other
Facilities
Share-based compensation
Total general and administrative
Professional fees
Professional fees decreased $2.7 million, or 39%, from 2022 to 2023 due primarily to the SEC investigation and class action and derivative lawsuits that were initiated in second half of 2022 and continued through the 2023 period. The retention limit of $2.5 million under the Company’s D&O insurance policy was reached during the second quarter of 2023. As such, the legal defense costs for the 2023 period representing covered claims as further defined under the provisions of the D&O policy, were offset by an insurance recovery totaling $3.3 million. Professional fees in the 2022 period primarily related to investigations conducted by the independent special committee of our Board of Directors. In addition, consulting expenses decreased approximately $1.1 million, as we discontinued certain contracts associated with analyzing potential strategic alternatives.
Salaries and benefits
Salaries and benefit expense decreased $0.4 million, or 25%, from 2022 to 2023 as a result of lower weighted average incremental headcount during the 2023 period resulting from the termination of a former officer and the RIF which was initiated in third quarter 2022.
Facilities
Facilities expense decreased $0.3 million, or 64%, from 2022 to 2023 as a result of the execution of the sublease agreement in March 2023, which resulted in the transfer of all utilities and operating costs of the premises to the subtenant and the full write-off of the ROU asset and future amortization (rent expense).
Share-based Compensation
Share-based compensation expense decreased $0.6 million, or 77%, from 2022 to 2023 as a result of forfeitures and cancellations of unvested stock options from employee terminations and board resignations in 2022.
Impairment of Long-lived Fixed and ROU Assets
In accordance with ASC Topic 360, Property, Plant and Equipment, the Company assesses all of its long-lived assets for impairment when impairment indicators are identified. Based on the assessment performed on September 30, 2022, the Company recorded a non-cash impairment related to its long-lived assets which was triggered by the Company’s
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announcement during the third quarter reporting period that it was discontinuing further development of its lead development asset, Ampion. Since the carrying value of the long-lived assets exceeded its undiscounted cash flows, an impairment loss, calculated as the difference between carrying value and fair value, was necessary. Accordingly, the Company recorded a $1.6 million impairment loss for the year ended December 31, 2022 through a direct reduction to the cost basis of the affected assets in its balance sheet.
In addition, the Company performed an assessment of potential impairment of the ROU asset consistent with the approach applied to other long-lived assets. ROU assets are reviewed for recoverability whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. If the carrying amount of an asset exceeds its estimated future undiscounted cash flows, an impairment loss is recorded for the excess of the asset’s carrying amount over its fair value. Accordingly, the Company recorded a $0.3 million impairment loss on the ROU asset for the year ended December 31, 2022.
There were no impairment charges for the year ended December 31, 2023.
Other Income
Other income is summarized as follows:
Year Ended December 31,
Interest income
Rental income
Gain from elimination of ARO obligation, net
Derivative gain
Total other income
Other income
We recognized interest income of $0.3 million during the 2023 period, which increased $0.1 million from the 2022 period. The increase is attributable to an increase in interest rates since the third quarter of 2022, partially offset by the decrease in cash and cash equivalents. We also recognized a non-cash gain of $0.3 million related to the elimination of its ARO and derecognition of the ARO asset in conjunction with the sublease agreement entered into on March 1, 2023. In addition, we also recognized $0.3 million of rental income associated with the sublease agreement during the 2023 period. There was no derivative gain on the fair value of warrant liability during the 2023 period due to the adoption of ASU 2020-06 which converted the warrant liability to stockholder’s equity effective January 1, 2023.
Cash Flows
Cash flows for the respective periods are as follows:
Year Ended December 31,
Net cash used in operating activities
Net cash used in investing activities
Net cash used in financing activities
Net change in cash and cash equivalents
Net Cash Used in Operating Activities
During the 2023 period, our operating activities used approximately $8.6 million in cash and cash equivalents, which is consistent with our reported net loss of $8.6 million.
During the 2022 period, our operating activities used approximately $21.1 million in cash and cash equivalents, which was more than our reported net loss of $16.3 million. The difference of approximately $4.8 million is attributable to a non-cash adjustment of $5.8 million related to the warrant derivative gain and a decrease in accounts payable and accrued expenses of $4.0 million, partially offset by non-cash charges related to impairment loss, depreciation, accretion,
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amortization and stock-based compensation totaling $3.9 million and decreases in prepaid expenses and other of $1.1
million.
Net Cash Used in Investing Activities
During the 2023 period and the 2022 period, there was no change in cash related to investing activities.
Net Cash Used in (Provided by) Financing Activities
During the 2023 period, we generated gross proceeds of $0.1 million from the sale of 28,826 shares of common stock from the ATM Agreement, which was offset by offering related costs of $0.1 million.
During the 2022 period, we settled a tax liability of $79,000 related to the vesting of restricted stock awards. As a result of the settlement, the Company withheld 9,234 common shares for taxes which represented the fair value of the tax settlement. In addition, the Company paid $32,000 in offering costs in 2022 related to the registered direct offering, which was finalized in December 2021.
Contractual Obligations and Commitments
Our contractual obligations as of December 31, 2023 primarily consist of employment agreements, CDMO agreement, non-clinical agreements with laboratories, and a non-cancellable operating lease arrangement for our office and manufacturing facility. As of December 31, 2023, the value of our obligation under our non-cancellable operating lease arrangement was $0.3 million. For a more detailed description of our contractual obligations see Note 6 to the Financial Statements.
Liquidity and Capital Resources
Since inception, we have not generated operating revenue, profits or operating cash flow. Over this period, we have continued to be focused on research and non-clinical/clinical development, all of which has required raising a substantial amount of capital.
As of December 31, 2023, we had $4.1 million of cash and cash equivalents and an insurance recovery receivable of $0.9 million. As of February 29, 2024, we had $3.4 million in cash and cash equivalents and $0.5 million of an insurance recovery receivable. While we continued to implement cost reductions in 2023 and additional cost reductions in February and March 2024, we have finite cash resources available to fund our now limited operations. Our activities currently consist of taking steps to preserve cash to adequately fund an orderly wind down of the Company’s operations and to maximize the Company’s cash position and pursuit of the resolution of currently pending legal proceedings. Consistent with this goal, on March 25, 2024, the Board of Directors determined to pursue voluntary delisting of Ampio’s common stock from the NYSE American. After delisting, the Company expects to suspend its reporting obligations under the Exchange Act and deregister its common stock under Section 12(b) of the Exchange Act.
Our lack of operating revenue or cash inflows and our cash resources at December 31, 2023 raise substantial doubt as to our ability to continue as a going concern. The financial statements as of and for the year ended December 31, 2023 do not include any adjustments to reflect the future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that will likely result when the Company is unable to continue as a going concern.
While the Board of Directors remains open to strategic options, given our prior efforts to develop similar strategic options, the Board of Directors believes that more likely options include the liquidation and wind up of the Company through a dissolution pursuant to a plan of liquidation and dissolution that would be subject to Board and stockholder approval or bankruptcy (should our net assets decline to levels that would require such action).
