We closed on the Private Placement in April 2024 and received gross proceeds of $3,001,235. In addition, we expect the AxoBio Disposition, which closed on March 26, 2024, to further reduce our operating expenses. Furthermore, we have refocused our efforts on aesthetic products that have near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that will take more than a year to commercialize. We are also exploring out-licensing certain research and development programs to generate non-dilutive liquidity. Finally, in the third quarter of 2023, we significantly reduced our future operating expenses by terminating certain executives serving as part-time consultants and full-time employees in non-core areas or overlapping business functions. This workforce reduction is expected to result in $2,000,000 to $3,000,000 in annual savings. Collectively, these activities are anticipated to assist us in extending our cash runway.
Comparison of Results of Operations for the Three Months Ended March 31, 2024 and 2023
The following table sets forth our results of operations for the three months ended March 31, 2024 and 2023:
| | | | | | | | | | | | | | | | |
| | For the Three Months Ended March 31, | | | | | | | |
| | 2024 | | | 2023 | | | Change | | | % Change | |
| | (unaudited) | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | $ | 429,420 | | | $ | 740,325 | | | $ | (310,905 | ) | | | -42 | % |
General and administrative | | | 927,394 | | | | 510,445 | | | | 416,949 | | | | 82 | % |
Depreciation and amortization of intangibles | | | 23,531 | | | | 24,101 | | | | (570 | ) | | | -2 | % |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 1,380,345 | | | | 1,274,871 | | | | 105,474 | | | | 8 | % |
| | | | | | | | | | | | | | | | |
Loss from operations | | | (1,380,345 | ) | | | (1,274,871 | ) | | | (105,474 | ) | | | 8 | % |
Other expenses, net | | | (2,172,817 | ) | | | (553,844 | ) | | | (1,618,973 | ) | | | 292 | % |
| | | | | | | | | | | | | | | | |
Net loss income before taxes | | $ | (3,553,162 | ) | | $ | (1,828,715 | ) | | $ | (1,724,447 | ) | | | 94 | % |
| | | | | | | | | | | | | | | | |
Operating Expenses
Total operating expenses were $1,380,345 and $1,274,871 for the three months ended March 31, 2024 and 2023, respectively. This increase reflects a higher level of expenses resulting from the execution of our strategic plan to commercialize our technologies.
Research and development expenses decreased from $740,325 for the three months ended March 31, 2023 to $429,420 for the three months ended March 31, 2024. This decrease was driven by our strategic realignment, which refocused our efforts on aesthetic products that have near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that will take more than a year to commercialize. Also contributing to the decrease was the termination of employees in non-core or overlapping business areas in the third quarter of 2023.
General and administrative expenses were $927,394 and $510,445 for the three months ended March 31, 2024 and 2023, respectively. This increase was primarily driven by an increase in insurance costs and salaries and benefits for personnel.
Depreciation and amortization expense decreased slightly to $23,531 for the three months ended March 31, 2024 as compared to $24,101 for the comparable period of 2023.
Other Expenses, Net
Other expenses, net, were $2,172,817 for the three months ended March 31, 2024, as compared to $553,844 in the comparable period of 2023. The increase between periods was primarily due to an unfavorable change in the fair value of the Forward Purchase Agreement of $2,156,837, partially offset by a decrease of $238,266 in interest expense and the amortization of debt discount, reflecting a lower level of average debt outstanding. In addition, the 2023 period includes an unfavorable change in the fair value of derivative liabilities related to the Convertible Notes of $325,085.
Discontinued Operations, Net
We had a loss from discontinued operations of $1,252,276, net of tax, in 2024, which reflects the results of the AxoBio business through the closing of the AxoBio Disposition on March 26, 2024. There have been no sales of AxoBio’s products since October 2023. We recognized a non-cash gain on the AxoBio Disposition of $1,534,479, due principally to the change in the fair value of the stock consideration between the AxoBio Acquisition and the AxoBio Disposition. See Note 1 to the accompanying unaudited condensed consolidated financial statements.
Comparison of Results of Operations for the Years Ended December 31, 2023 and 2022
The following table sets forth our results of operations for the years ended December 31, 2023 and 2022:
| | | | | | | | | | | | |
| | Year Ended December 31, | | | | |
| | 2023 | | | 2022 | | | Change | |
Operating expenses: | | | | | | | | | | | | |
Research and development | | $ | 2,497,218 | | | $ | 2,196,063 | | | $ | 301,155 | |
General and administrative | | | 2,622,945 | | | | 3,217,280 | | | | (594,335 | ) |
Depreciation and amortization of intangibles | | | 97,113 | | | | 94,298 | | | | 2,815 | |
Restructuring charges | | | 726,280 | | | | — | | | | 726,280 | |
| | | | | | | | | | | | |
Total operating expenses | | | 5,943,556 | | | | 5,507,641 | | | | 435,915 | |
| | | | | | | | | | | | |
Loss from operations | | | (5,943,556 | ) | | | (5,507,641 | ) | | | (435,915 | ) |
Other (expenses) income, net | | | (10,261,696 | ) | | | (3,543,693 | ) | | | (6,718,003 | ) |
| | | | | | | | | | | | |
Net loss from continuing operations before taxes | | $ | (16,205,252 | ) | | $ | (9,051,334 | ) | | $ | (7,153,918 | ) |
| | | | | | | | | | | | |
Operating Expenses
Total operating expenses were $5,943,556 and $5,507,641 for the years ended December 31, 2023 and 2022, respectively. This increase reflects a higher level of expenses in 2023 resulting from the execution of our strategic plan to commercialize our technologies.
Research and development expenses were $2,497,218 and $2,196,063 for the years ended December 31, 2023, and 2022, respectively. This increase was principally due to an increase in salaries and benefits of our research and development personnel.
General and administrative expenses were $2,622,495 and $3,217,280 for the years ended December 31, 2023 and 2022, respectively. This decrease was primarily driven by the $1,278,062 write-off of costs associated with our aborted initial public offering in October 2022, prior to pursuing the Business Combination. The decrease in general and administrative expenses was partially offset by an increase in salaries and benefits for personnel.
Depreciation and amortization expense was $97,113 for the year ended December 31, 2023, in line with $94,298 for the comparable period of 2022.
Restructuring charges of $726,280 for the year ended December 31, 2023, were related to our strategic realignment and consist of severance from the termination of employees in non-core areas or overlapping business functions (see “Restructuring” below).
Other Income (Expenses), Net
Other expenses, net were $10,261,696 for the year ended December 31, 2023, as compared to $3,543,693 in 2022. The increase between periods was primarily due to an unfavorable change in the fair value of the Forward Purchase Agreement (as defined under “Certain Relationships and Related Party Transactions” in this prospectus) of $10,268,130 since the Closing Date, partially offset by a decrease of $2,859,950 in interest expense and the amortization of debt discount, reflecting a lower level of average debt outstanding in 2023. In addition, the 2022 fiscal year includes a loss on debt extinguishment of $1,064,692.
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