2023 Q1 Form 10-K Financial Statement

#000143774923006899 Filed on March 16, 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 $1.352M $1.695M $6.044M
YoY Change -24.72% 33.36% 31.76%
% of Gross Profit
Research & Development $3.508M $3.486M $28.05M
YoY Change 58.88% 70.88% 417.22%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $3.508M $5.181M $28.05M
YoY Change 58.88% 56.48% 417.22%
Operating Profit -$4.860M -$34.09M
YoY Change 21.38% 240.59%
Interest Expense $102.0K -$177.0K $288.0K
YoY Change 3300.0% 8750.0% 2518.18%
% of Operating Profit
Other Income/Expense, Net -$253.0K $611.0K -$956.0K
YoY Change -181.88% 7537.5% 55.95%
Pretax Income -$5.113M -$4.747M -$35.05M
YoY Change 38.38% 43.63% 229.94%
Income Tax $0.00 -$12.00K -$116.0K
% Of Pretax Income
Net Earnings -$5.100M -$4.735M -$34.90M
YoY Change 39.12% 33.83% 245.54%
Net Earnings / Revenue
Basic Earnings Per Share -$0.65 -$67.91
Diluted Earnings Per Share -$19.61 -$5.68 -$67.91
COMMON SHARES
Basic Shares Outstanding 14.60M 31.71M 514.4K
Diluted Shares Outstanding

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $5.235M $1.285M $1.285M
YoY Change -29.12% -89.17% -89.17%
Cash & Equivalents $5.200M $1.300M $1.285M
Short-Term Investments
Other Short-Term Assets $2.549M $443.0K $443.0K
YoY Change 1300.55% 386.81% 386.81%
Inventory
Prepaid Expenses $2.549M $443.0K
Receivables
Other Receivables
Total Short-Term Assets $7.833M $1.777M $1.777M
YoY Change -1.26% -85.53% -85.53%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $8.642M $3.201M $3.201M
YoY Change 173.91% 439.8% 439.8%
Total Long-Term Assets $8.642M $3.201M $3.201M
YoY Change 173.91% 439.8% 439.8%
TOTAL ASSETS
Total Short-Term Assets $7.833M $1.777M $1.777M
Total Long-Term Assets $8.642M $3.201M $3.201M
Total Assets $16.48M $4.978M $4.978M
YoY Change 48.58% -61.33% -61.33%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $7.341M $2.865M $2.865M
YoY Change 84.17% 347.66% 347.66%
Accrued Expenses $1.363M $2.993M $3.318M
YoY Change 161.61% 48.17% 64.26%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $650.0K $650.0K
YoY Change
Long-Term Debt Due $1.000M $1.000M $1.000M
YoY Change
Total Short-Term Liabilities $9.746M $7.833M $7.833M
YoY Change 116.24% 194.47% 194.47%
LONG-TERM LIABILITIES
Long-Term Debt $4.194M $5.194M $5.194M
YoY Change
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $4.194M $5.194M $5.194M
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $9.746M $7.833M $7.833M
Total Long-Term Liabilities $4.194M $5.194M $5.194M
Total Liabilities $13.94M $13.03M $13.03M
YoY Change 209.3% 389.74% 389.74%
SHAREHOLDERS EQUITY
Retained Earnings -$96.20M -$91.10M
YoY Change 60.87% 62.21%
Common Stock $16.00K $1.000K
YoY Change 23.08% -92.31%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $2.500M -$8.000M -$8.049M
YoY Change
Total Liabilities & Shareholders Equity $16.48M $4.978M $4.978M
YoY Change 48.58% -61.33% -61.33%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$5.100M -$4.735M -$34.90M
YoY Change 39.12% 33.83% 245.54%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities -$9.800M -$5.005M -$15.30M
YoY Change 117.78% 200.6% 128.36%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities $0.00 -$656.0K
YoY Change -100.0% 21.48%
Cash From Investing Activities $0.00 -$656.0K
YoY Change -100.0% 21.48%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $13.70M 5.349M $5.354M
YoY Change -46.96%
NET CHANGE
Cash From Operating Activities -$9.800M -5.005M -$15.30M
Cash From Investing Activities 0.000 -$656.0K
Cash From Financing Activities $13.70M 5.349M $5.354M
Net Change In Cash $3.950M 344.0K -$10.58M
YoY Change -188.15% -115.6% -471.95%
FREE CASH FLOW
Cash From Operating Activities -$9.800M -$5.005M -$15.30M
Capital Expenditures
Free Cash Flow
YoY Change

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<table border="0" cellpadding="0" cellspacing="0" style="width: 100%; text-indent: 0px;"><tbody><tr style="vertical-align: top;"><td style="width: 36pt;"> <p style="margin: 0pt; text-align: justify; font-family: 'Times New Roman', Times, serif; font-size: 10pt;"><b><em style="font: inherit;">2.</em></b></p> </td><td style="width: auto;"> <p style="margin: 0pt; text-align: justify; font-family: 'Times New Roman', Times, serif; font-size: 10pt;"><b>Risks and Uncertainties</b></p> </td></tr> </tbody></table> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">The Company operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (“FDA”) in the United States, the Therapeutic Goods Administration in Australia, the European Medicines Agency in the European Union, and comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, <em style="font: inherit;"> may </em>take many years, and is normally expected to involve substantial expenditure.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">We have incurred losses of $91.1 million since our inception in <em style="font: inherit;">2011.</em> For the year ended <em style="font: inherit;"> December 31, 2022, </em>we incurred a net loss of $34.9 million. Included in the net loss for the year ended <em style="font: inherit;"> December 31, 2022 </em>was $17.7 million of in-process research and development (“IPR&amp;D”) written off as research and development (“R&amp;D”) expense as the result of the acquisition of CPP. We incurred negative cash flows from operating activities of approximately $15.3 million for this period. As we continue to pursue development activities and seek commercialization of our lead assets, we expect to incur substantial losses, which are likely to generate negative net cash flows from operating activities. As of <em style="font: inherit;"> December 31, 2022, </em>we had cash of $1.3 million, negative working capital of $6.0 million (current assets less current liabilities), and stockholders’ deficit of $8.0 million. The Company’s principal sources of cash have historically included the issuance of equity securities and convertible debt. CPP’s principal sources of cash have historically also included issuance of equity securities, convertible debt and development partners.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">The accompanying Consolidated Financial Statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business and do <em style="font: inherit;">not</em> include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties. Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our ivospemin (SBP-<em style="font: inherit;">101</em>), eflornithine (CPP-<em style="font: inherit;">1X</em>) and eflornithine sachets (CPP-<em style="font: inherit;">1X</em>-S) product candidates in the United States, Australia, the European Union or other markets, and Flynpovi outside of North America and ultimately our ability to market and sell our product candidates. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern. See Note <em style="font: inherit;">3</em> titled “Liquidity and Business Plan.”</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><em style="font: inherit;"> December 2023 </em>marked <em style="font: inherit;">33</em> months since the World Health Organization declared the spread of a novel strain of coronavirus (“COVID-<em style="font: inherit;">19”</em>) a global pandemic. While there is still some uncertainty of the situation, we continue to be unable to make any prediction as to the ultimate impact COVID-<em style="font: inherit;">19</em> will have on the Company's business, financial condition, results of operation and cash flows. During the spring of <em style="font: inherit;">2021,</em> the Company also experienced a delay in the manufacturing of the active product substance, which is manufactured in India. There was also a delay in the final manufacturing steps which are completed in the United States, in part related to COVID-<em style="font: inherit;">19.</em> To date there has been <em style="font: inherit;">no</em> disruption in supply for our clinical or preclinical testing. In <em style="font: inherit;"> January </em>of <em style="font: inherit;">2022,</em> the Company announced the opening of a global randomized Phase II/III clinical trial, which is expected to be conducted in the United States, Europe and Australia. While regulatory approval and site openings have been slower than expected the Company does <em style="font: inherit;">not</em> expect any significant delays in enrollment or data. The Company’s administrative operations have been decentralized since inception so the Company experienced <em style="font: inherit;">no</em> administrative disruptions or additional costs due to the pandemic or related restrictions.</p>
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<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt 0pt 0pt 9pt;"><b><i>Use of estimates</i></b></p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">The preparation of Consolidated Financial Statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the Consolidated Financial Statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimates.</p>
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