2023 Q1 Form 10-K Financial Statement

#000141057823000319 Filed on March 21, 2023

View on sec.gov

Income Statement

Concept 2023 Q1 2022 Q4 2022
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.044M $4.476M $9.810M
YoY Change 13.79% 55.58% 18.45%
% of Gross Profit
Research & Development $877.7K $1.413M $6.325M
YoY Change -40.94% 3.78% 45.86%
% of Gross Profit
Depreciation & Amortization $1.690K $1.520K $5.714K
YoY Change 28.13% 22.58% 15.06%
% of Gross Profit
Operating Expenses $2.922M $5.889M $16.13M
YoY Change -10.99% 38.94% 27.87%
Operating Profit
YoY Change
Interest Expense $1.210M $10.37M $10.56M
YoY Change 26150.76% 411455.95% 148437.83%
% of Operating Profit
Other Income/Expense, Net $1.210M $8.405M $10.56M
YoY Change 26150.69% 148437.82%
Pretax Income -$1.712M $4.482M -$5.574M
YoY Change -47.78% -205.81% -55.8%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income 0.0%
Net Earnings -$1.712M $4.366M -$5.574M
YoY Change -47.78% -203.08% -55.8%
Net Earnings / Revenue
Basic Earnings Per Share $0.26 $0.81
Diluted Earnings Per Share $0.26 $0.62 $0.81
COMMON SHARES
Basic Shares Outstanding 7.355M 6.848M 6.989M
Diluted Shares Outstanding 7.501M 6.989M

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $35.78M $37.48M $37.48M
YoY Change 14.38% 9.54% 9.54%
Cash & Equivalents $35.80M $37.50M $37.48M
Short-Term Investments
Other Short-Term Assets $726.3K $1.107M $1.107M
YoY Change -30.99% -14.19% -14.19%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $36.51M $38.59M $38.59M
YoY Change 12.91% 8.68% 8.68%
LONG-TERM ASSETS
Property, Plant & Equipment $22.49K $22.15K $22.15K
YoY Change 17.6% 8.31% 8.31%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $22.49K $22.15K $22.15K
YoY Change 17.6% 8.31% 8.37%
TOTAL ASSETS
Total Short-Term Assets $36.51M $38.59M $38.59M
Total Long-Term Assets $22.49K $22.15K $22.15K
Total Assets $36.53M $38.61M $38.61M
YoY Change 12.91% 8.68% 8.68%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $355.9K $660.2K $660.2K
YoY Change -11.32% -49.08% -49.08%
Accrued Expenses $538.9K $536.7K $536.7K
YoY Change 101.11% -23.15% -23.15%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $1.277M $1.313M $1.313M
YoY Change 90.76% -34.19% -34.19%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.067M $1.880M $1.880M
YoY Change
Total Long-Term Liabilities $1.067M $1.880M $1.880M
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $1.277M $1.313M $1.313M
Total Long-Term Liabilities $1.067M $1.880M $1.880M
Total Liabilities $2.343M $3.193M $3.193M
YoY Change 250.09% 60.06% 60.06%
SHAREHOLDERS EQUITY
Retained Earnings -$21.81M -$19.83M
YoY Change 25.2% 40.23%
Common Stock $737.00 $728.00
YoY Change 8.06% 8.01%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $31.46M $32.69M $35.41M
YoY Change
Total Liabilities & Shareholders Equity $36.53M $38.61M $38.61M
YoY Change 12.91% 8.68% 8.68%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$1.712M $4.366M -$5.574M
YoY Change -47.78% -203.08% -55.8%
Depreciation, Depletion And Amortization $1.690K $1.520K $5.714K
YoY Change 28.13% 22.58% 15.06%
Cash From Operating Activities -$1.696M -$2.784M -$11.21M
YoY Change -51.35% 36.1% 28.71%
INVESTING ACTIVITIES
Capital Expenditures $2.038K $2.130K $7.414K
YoY Change -166.56% 131.76%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$2.038K -$2.130K -$7.414K
YoY Change -33.44% 131.76%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 0.000 13.93M 14.48M
YoY Change -100.0% 180.41% -61.0%
NET CHANGE
Cash From Operating Activities -1.696M -2.784M -11.21M
Cash From Investing Activities -2.038K -2.130K -7.414K
Cash From Financing Activities 0.000 13.93M 14.48M
Net Change In Cash -1.698M 11.14M 3.264M
YoY Change -42.1% 281.74% -88.51%
FREE CASH FLOW
Cash From Operating Activities -$1.696M -$2.784M -$11.21M
Capital Expenditures $2.038K $2.130K $7.414K
Free Cash Flow -$1.698M -$2.786M -$11.22M
YoY Change 36.42% 28.74%

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-indent:0pt;margin:0pt 0pt 12pt 0pt;">Note 1 – Organization, Business, Risks and Uncertainties:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;text-indent:0pt;margin:0pt 0pt 12pt 0pt;">Organization and Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">On May 17, 2020, Neurotrope, Inc. (“Neurotrope” or “the Parent”) announced plans for the complete legal and structural separation of its wholly owned subsidiary, Neurotrope Bioscience, Inc., from Neurotrope (the “Spin-Off”). Under the Separation and Distribution Agreement, Neurotrope planned to distribute all of its equity interest in this wholly owned subsidiary to Neurotrope’s stockholders. Following the Spin-Off, Neurotrope does not own any equity interest in the Company, and we operate independently from Neurotrope. On December 7, 2020 we became an independent company, Synaptogenix, Inc., a Delaware corporation (formerly known as Neurotrope Bioscience, Inc.) (the “Company” or “Synaptogenix”) as the Company amended and restated their certificate of incorporation which, among other things, changed its name to Synaptogenix, Inc. Our shares of common stock are listed on The Nasdaq Capital Market under the symbol “SNPX.”</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">Neurotrope Bioscience, Inc. was incorporated in Delaware on October 31, 2012 to advance new therapeutic and diagnostic technologies in the field of neurodegenerative disease, primarily Alzheimer’s disease (“AD”). The Company is collaborating with Cognitive Research Enterprises, Inc. (formerly known as the Blanchette Rockefeller Neurosciences Institute, or BRNI) (“CRE”) in this process. The exclusive rights to certain technology were licensed by CRE to the Company on February 28, 2013 (see Note 3 - Collaborative Agreements and Commitments).</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">In connection with the separation from Neurotrope, we entered into a Separation and Distribution Agreement and several other ancillary agreements. These agreements govern the relationship between the parties after the separation and allocate between the parties’ various assets, liabilities, rights and obligations following the separation, including employee benefits, intellectual property, information technology, insurance and tax-related liabilities.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;"><span style="font-style:normal;font-weight:normal;">On December 16, 2022, Synaptogenix issued a press release announcing that an extended confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD (Study #204) did not achieve statistical significance on the primary endpoint, which was changed from baseline to Week 13 in the SIB total score assessment obtained after completion of the second seven-dose course of treatment (week 28 of trial). On March 7, 2023, the Company announced results of its analysis of secondary endpoints and post hoc analysis from our Phase 2 study of Bryostatin-1. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB (Severe Impairment Battery) total score were not statistically significant in the total patient population, and no pre-specified secondary endpoints were met with statistical significance in the low-to-moderately severe AD patient stratum. However, nearly all pre-specified secondary endpoints in the most advanced and severe AD (MMSE: 10-14) patient population, with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition) scores of 10-14, were achieved with statistical significance (p = &lt;0.05, 2-tailed). Data also showed statistical significance in exploratory secondary endpoints for the MMSE-2 10-14 stratum, and post hoc analysis was positive. </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;text-indent:0pt;margin:0pt 0pt 12pt 0pt;">Liquidity Uncertainties</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">As of December 31, 2022, the Company had approximately $37.5 million in cash and cash equivalents as compared to $34.2 million at December 31, 2021. The Company expects that its current cash and cash equivalents, approximately $36.0 million as of the date of this annual report will be sufficient to support its projected operating requirements for at least the next 12 months from this date. The operating requirements include the current development plans for Bryostatin-1, our novel drug candidate targeting the activation of PKC epsilon and other development projects.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">The Company expects to need additional capital in order to initiate and pursue potential additional development projects, including the continuing development beyond the ongoing Phase 2 trial of Bryostatin-1. Any additional equity financing, if available, may not be on favorable terms and would likely be significantly dilutive to the Company’s current stockholders, and debt financing, if available, may involve restrictive covenants. If the Company is able to access funds through collaborative or licensing arrangements, it may be required to relinquish rights to some of its technologies or product candidates that the Company would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, will likely have a materially adverse effect on our business, financial condition and results of operations.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;text-indent:0pt;margin:0pt 0pt 12pt 0pt;">Other Risks and Uncertainties</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">The Company operates in an industry that is subject to rapid technological change, intense competition, and significant government regulation. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory and other risk. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities, the ability to obtain regulatory approval, the limited supply of raw materials, the ability to obtain favorable licensing, manufacturing or other agreements, including risk associated with our CRE licensing agreement, and the ability to raise capital to achieve strategic objectives.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">CRE has entered into a material transfer agreement with the National Cancer Institute of the National Institutes of Health (“NCI”), pursuant to which the NCI has agreed to supply bryostatin required for the Company’s pre-clinical research and clinical trials. This agreement does not provide for a sufficient amount of bryostatin to support the completion of all of the clinical trials that the Company is required to conduct in order to seek U.S. Food and Drug Administration (“FDA”) approval. Therefore, CRE or the Company would have to enter into one or more subsequent agreements with the NCI for the supply of additional amounts of bryostatin. If CRE or the Company were unable to secure such additional agreements, or if the NCI otherwise discontinues the supply, the Company would have to either secure another source of bryostatin or discontinue its efforts to develop and commercialize Bryostatin-1 for the treatment of AD. In June 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to be the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company received its initial order of one gram synthetic bryostatin. See Note 3.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt;">The Company also faces the ongoing risk that the coronavirus pandemic may slow, for an unforeseeable period, the conduct of the Company’s trial. In order to prioritize patient health and that of the investigators at clinical trial sites, we will monitor enrollment of new patients in our ongoing Phase 2 clinical trial. In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services. These and other factors outside of our control could delay our ability to conduct clinical trials or release clinical trial results. In addition, the effects of a pandemic resurgence may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and suppliers.</p>
CY2022Q4 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
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CY2021Q4 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
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CY2022 us-gaap Use Of Estimates
UseOfEstimates
<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;margin:0pt 0pt 12pt 0pt;"><b style="font-style:normal;font-weight:bold;text-decoration-line:none;">Use of Estimates:</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">The preparation of financial statements in conformity with GAAP requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Management evaluates its estimates on an ongoing basis using historical experience and other factors, including the general economic environment and actions it may take in the future. The Company adjusts such estimates when facts and circumstances dictate. However, these estimates may involve significant uncertainties and judgments and cannot be determined with precision. In addition, these estimates are based on management’s best judgment at a point in time and as such these estimates may ultimately differ from actual results.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Reclassification of Prior Year Presentation:</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations and do not affect previously reported cash flows.</p>
CY2022 us-gaap Reclassifications
Reclassifications
<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Reclassification of Prior Year Presentation:</b></p>
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