2023 Q2 Form 10-Q Financial Statement

#000141057823001232 Filed on May 15, 2023

View on sec.gov

Income Statement

Concept 2023 Q2 2023 Q1
Revenue $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.523M $2.044M
YoY Change -17.94% 13.79%
% of Gross Profit
Research & Development $307.2K $877.7K
YoY Change -84.17% -40.94%
% of Gross Profit
Depreciation & Amortization $1.720K $1.690K
YoY Change 24.64% 28.13%
% of Gross Profit
Operating Expenses $1.830M $2.922M
YoY Change -51.8% -10.99%
Operating Profit
YoY Change
Interest Expense -$2.057M $1.210M
YoY Change -4724.05% 26150.76%
% of Operating Profit
Other Income/Expense, Net -$2.264M $1.210M
YoY Change -5189.67% 26150.69%
Pretax Income -$4.094M -$1.712M
YoY Change 9.12% -47.78%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$4.094M -$1.712M
YoY Change 9.12% -47.78%
Net Earnings / Revenue
Basic Earnings Per Share $1.39 $0.26
Diluted Earnings Per Share $1.39 $0.26
COMMON SHARES
Basic Shares Outstanding 7.360M 7.355M
Diluted Shares Outstanding 7.361M 7.501M

Balance Sheet

Concept 2023 Q2 2023 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $32.90M $35.78M
YoY Change 14.41% 14.38%
Cash & Equivalents $32.90M $35.80M
Short-Term Investments
Other Short-Term Assets $516.3K $726.3K
YoY Change -35.77% -30.99%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $33.42M $36.51M
YoY Change 13.05% 12.91%
LONG-TERM ASSETS
Property, Plant & Equipment $21.44K $22.49K
YoY Change 3.18% 17.6%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $21.44K $22.49K
YoY Change 3.18% 17.6%
TOTAL ASSETS
Total Short-Term Assets $33.42M $36.51M
Total Long-Term Assets $21.44K $22.49K
Total Assets $33.44M $36.53M
YoY Change 13.04% 12.91%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $439.1K $355.9K
YoY Change 56.36% -11.32%
Accrued Expenses $68.14K $538.9K
YoY Change -80.26% 101.11%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $2.773M $1.277M
YoY Change 342.93% 90.76%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $3.757M $1.067M
YoY Change
Total Long-Term Liabilities $3.757M $1.067M
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $2.773M $1.277M
Total Long-Term Liabilities $3.757M $1.067M
Total Liabilities $6.530M $2.343M
YoY Change 943.11% 250.09%
SHAREHOLDERS EQUITY
Retained Earnings -$32.02M -$21.81M
YoY Change 51.24% 25.2%
Common Stock $738.00 $737.00
YoY Change 8.21% 8.06%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $24.83M $31.46M
YoY Change
Total Liabilities & Shareholders Equity $33.44M $36.53M
YoY Change 13.04% 12.91%

Cashflow Statement

Concept 2023 Q2 2023 Q1
OPERATING ACTIVITIES
Net Income -$4.094M -$1.712M
YoY Change 9.12% -47.78%
Depreciation, Depletion And Amortization $1.720K $1.690K
YoY Change 24.64% 28.13%
Cash From Operating Activities -$1.239M -$1.696M
YoY Change -50.89% -51.35%
INVESTING ACTIVITIES
Capital Expenditures $670.00 $2.038K
YoY Change -122.11%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$670.00 -$2.038K
YoY Change -77.89%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -1.641M 0.000
YoY Change -100.0%
NET CHANGE
Cash From Operating Activities -1.239M -1.696M
Cash From Investing Activities -670.0 -2.038K
Cash From Financing Activities -1.641M 0.000
Net Change In Cash -2.881M -1.698M
YoY Change 14.01% -42.1%
FREE CASH FLOW
Cash From Operating Activities -$1.239M -$1.696M
Capital Expenditures $670.00 $2.038K
Free Cash Flow -$1.240M -$1.698M
YoY Change -50.81%

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;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;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 the Company operates independently from Neurotrope. On December 7, 2020, the Company became an independent company, Synaptogenix, Inc., a Delaware corporation (formerly known as Neurotrope Bioscience, Inc.) (the “Company” or “Synaptogenix”) when the Company filed an amended and restated certificate of incorporation which, among other things, changed its name to Synaptogenix, Inc. The Company’s shares of common stock, par value $0.0001 per share (the “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”), a related party, in this process. The exclusive rights to certain technology were licensed by CRE to the Company on February 28, 2013 (see Note 4 - Related Party Transactions).</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, the Company 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;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">On December 16, 2022, the Company 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 Severe Impairment Battery (“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 (Mini Mental State Exam 2 (“MMSE”) (baseline scores: 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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><span style="font-style:italic;font-weight:bold;">Liquidity Uncertainties</span></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 March 31, 2023, the Company had approximately $35.8 million in cash and cash equivalents as compared to $37.5 million at December 31, 2022. The Company expects that its current cash and cash equivalents, approximately $35 million as of the date of this Quarterly Report on Form 10-Q, 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 Protein Kinase C 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;">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, </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">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;text-align:justify;margin:0pt;"><span style="font-style:italic;font-weight:bold;">Other Risks and Uncertainties</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> </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 and regulatory. 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 current 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>
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