2022 Q4 Form 10-Q Financial Statement

#000143774922026909 Filed on November 10, 2022

View on sec.gov

Income Statement

Concept 2022 Q4 2022 Q3 2021 Q3
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.695M $1.294M $924.0K
YoY Change 33.36% 40.04% -24.26%
% of Gross Profit
Research & Development $3.486M $2.329M $1.286M
YoY Change 70.88% 81.1% 66.36%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $5.181M $2.329M $1.286M
YoY Change 56.48% 81.1% 66.36%
Operating Profit -$3.623M -$2.210M
YoY Change 63.94% 10.72%
Interest Expense -$177.0K $87.00K $2.000K
YoY Change 8750.0% 4250.0% -33.33%
% of Operating Profit
Other Income/Expense, Net $611.0K -$835.0K -$336.0K
YoY Change 7537.5% 148.51% -242.37%
Pretax Income -$4.747M -$4.458M -$2.546M
YoY Change 43.63% 75.1% 44.66%
Income Tax -$12.00K -$56.00K -$404.0K
% Of Pretax Income
Net Earnings -$4.735M -$4.402M -$2.142M
YoY Change 33.83% 105.51% 28.19%
Net Earnings / Revenue
Basic Earnings Per Share -$0.21 -$0.16
Diluted Earnings Per Share -$5.68 -$211.8K -$161.2K
COMMON SHARES
Basic Shares Outstanding 31.71M 20.77M 13.43M
Diluted Shares Outstanding

Balance Sheet

Concept 2022 Q4 2022 Q3 2021 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $1.285M $941.0K $14.07M
YoY Change -89.17% -93.31% 29.46%
Cash & Equivalents $1.300M $900.0K $14.10M
Short-Term Investments
Other Short-Term Assets $443.0K $779.0K $118.0K
YoY Change 386.81% 560.17% -65.29%
Inventory
Prepaid Expenses $443.0K $779.0K $118.0K
Receivables
Other Receivables
Total Short-Term Assets $1.777M $1.766M $14.75M
YoY Change -85.53% -88.03% 29.0%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.201M $3.101M $53.00K
YoY Change 439.8% 5750.94% 1.92%
Total Long-Term Assets $3.201M $3.101M $53.00K
YoY Change 439.8% 5750.94% 1.92%
TOTAL ASSETS
Total Short-Term Assets $1.777M $1.766M $14.75M
Total Long-Term Assets $3.201M $3.101M $53.00K
Total Assets $4.978M $4.867M $14.80M
YoY Change -61.33% -67.12% 28.88%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.865M $5.394M $796.0K
YoY Change 347.66% 577.64% 88.63%
Accrued Expenses $2.993M $758.0K $543.0K
YoY Change 48.17% 39.59% -14.08%
Deferred Revenue
YoY Change
Short-Term Debt $650.0K $650.0K $0.00
YoY Change -100.0%
Long-Term Debt Due $1.000M $1.000M
YoY Change
Total Short-Term Liabilities $7.833M $7.952M $1.339M
YoY Change 194.47% 493.88% -30.84%
LONG-TERM LIABILITIES
Long-Term Debt $5.194M $5.194M $0.00
YoY Change
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $5.194M $5.194M $0.00
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $7.833M $7.952M $1.339M
Total Long-Term Liabilities $5.194M $5.194M $0.00
Total Liabilities $13.03M $13.15M $1.339M
YoY Change 389.74% 881.78% -30.98%
SHAREHOLDERS EQUITY
Retained Earnings -$91.10M -$86.40M -$52.60M
YoY Change 62.21% 64.26% 16.51%
Common Stock $1.000K $21.00K $13.00K
YoY Change -92.31% 61.54% 30.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$8.000M -$8.300M $13.50M
YoY Change
Total Liabilities & Shareholders Equity $4.978M $4.867M $14.80M
YoY Change -61.33% -67.12% 28.88%

Cashflow Statement

Concept 2022 Q4 2022 Q3 2021 Q3
OPERATING ACTIVITIES
Net Income -$4.735M -$4.402M -$2.142M
YoY Change 33.83% 105.51% 28.19%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities -$5.005M -$1.593M -$1.386M
YoY Change 200.6% 14.94% 84.8%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities $0.00 -$1.000K
YoY Change -100.0%
Cash From Investing Activities $0.00 -$1.000K
YoY Change -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 5.349M 5.000K 9.053M
YoY Change -99.94% -3.28%
NET CHANGE
Cash From Operating Activities -5.005M -1.593M -1.386M
Cash From Investing Activities 0.000 -1.000K
Cash From Financing Activities 5.349M 5.000K 9.053M
Net Change In Cash 344.0K -1.589M 7.667M
YoY Change -115.6% -120.73% -10.95%
FREE CASH FLOW
Cash From Operating Activities -$5.005M -$1.593M -$1.386M
Capital Expenditures
Free Cash Flow
YoY Change

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us-gaap Net Cash Provided By Used In Financing Activities
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us-gaap Nature Of Operations
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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: left; font-family: &quot;Times New Roman&quot;, 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: left; font-family: &quot;Times New Roman&quot;, 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 $86.4 million since our inception in <em style="font: inherit;">2011.</em> For the <em style="font: inherit;">nine</em> months ended <em style="font: inherit;"> September 30, 2022, </em>we incurred a net loss of $30.2 million. Included in the net loss for the <em style="font: inherit;">nine</em> months ended <em style="font: inherit;"> September 30, 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 subsequent to the acquisition of CPP. We also incurred negative cash flows from operating activities of approximately $10.3 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;"> September 30, 2022, </em>we had cash of $0.9 million, negative working capital of $6.2 million (current assets less current liabilities), and stockholders’ deficit of $8.3 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 condensed 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. The condensed<b> </b>consolidated financial statements 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 current independent registered public accounting firm included a paragraph emphasizing this going concern uncertainty in their audit report regarding our <em style="font: inherit;">2021</em> financial statements dated <em style="font: inherit;"> March 24, 2022. </em>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;">4</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;">In <em style="font: inherit;"> March </em>of <em style="font: inherit;">2020,</em> the World Health Organization declared the spread of a novel strain of coronavirus (“COVID-<em style="font: inherit;">19”</em>) a global pandemic. Early in the pandemic, federal, state and local governmental authorities took actions to combat the spread of COVID-<em style="font: inherit;">19,</em> including through issuances of “stay-at-home” directives and similar mandates for many individuals to substantially restrict daily activities and for many businesses to curtail or cease normal operations. These measures, while intended to protect human life, led to initially significantly reduced economic activity. Vaccines became available at the end of <em style="font: inherit;">2020.</em> Distribution in the United States accelerated during the <em style="font: inherit;">first</em> quarter of <em style="font: inherit;">2021</em> and then leveled off in the <em style="font: inherit;">second</em> quarter. In the fall of <em style="font: inherit;">2021,</em> infection rates increased in the United States and other parts of the world as the result of the Delta variant. In winter of <em style="font: inherit;">2021,</em> the Omicron variant caused another increase in infections. In the <em style="font: inherit;">third</em> quarter of <em style="font: inherit;">2022,</em> infection rates were continuing to decrease. The development and uncertainty of the situation continues to preclude any prediction as to the ultimate impact of COVID-<em style="font: inherit;">19</em> on the Company’s business, financial condition, results of operations and cash flows, which will depend largely on future developments directly or indirectly relating to the duration and scope of the COVID-<em style="font: inherit;">19</em> outbreak in the United States, Australia, Europe and the rest of the world. During the spring of <em style="font: inherit;">2021,</em> the Company 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, neither <em style="font: inherit;">one</em> of these delays have caused a 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 clinical trial, which is expected to be conducted in the United States, Europe and Australia. While opening of clinical sites in the US and the rest of the world has been slower than originally anticipated, due in part to resource fatigue in the medical community, the Company does <em style="font: inherit;">not</em> expect any serious disruption to the conduct of this new clinical trial associated with COVID-<em style="font: inherit;">19.</em> The Company’s administrative operations have been decentralized since inception of the Company, so the Company experienced <em style="font: inherit;">no</em> administrative disruptions or additional costs due to the pandemic or related restrictions.</p>
CY2022Q3 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
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us-gaap Net Income Loss
NetIncomeLoss
-30200000 usd
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
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CY2022Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
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CY2022Q3 pbla Working Capital
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CY2022Q3 us-gaap Stockholders Equity
StockholdersEquity
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us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Exercisable Options Weighted Average Remaining Contractual Term2
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us-gaap Use Of Estimates
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<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;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 condensed 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 condensed consolidated financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates, particularly given the significant social and economic disruptions and uncertainties.</p>
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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CY2022Q3 pbla License Agreement Milestone Payments Achievement
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CY2022Q3 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
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CY2022Q3 pbla Shares Reserved For Issuance Weighted Average Exercise Price
SharesReservedForIssuanceWeightedAverageExercisePrice
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us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
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us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
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CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Available For Grant
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant
2463636
CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
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CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
8821 usd
pbla Sharebased Compensation Arrangement By Sharebased Payment Award Number Of Shares Available For Grant Grants In Period
SharebasedCompensationArrangementBySharebasedPaymentAwardNumberOfSharesAvailableForGrantGrantsInPeriod
1596754
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
0.35
us-gaap Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
17771
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExpirationsInPeriodWeightedAverageExercisePrice
0.22
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriod
-0
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
19500
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
14.07
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Available For Grant
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant
4023119
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
3.64
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
70506 usd
CY2022Q3 us-gaap Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Number Of Outstanding Options
ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions
4023119
us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Outstanding Options Weighted Average Remaining Contractual Term2
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2
P6Y10M17D
CY2022Q3 us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Outstanding Options Weighted Average Exercise Price Beginning Balance1
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1
3.637
CY2022Q3 us-gaap Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Number Of Exercisable Options
ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions
3646123

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