2022 Q3 Form 10-Q Financial Statement

#000143774922020539 Filed on August 15, 2022

View on sec.gov

Income Statement

Concept 2022 Q3 2022 Q2 2022 Q1
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.294M $1.258M $1.796M
YoY Change 40.04% -47.41% 56.17%
% of Gross Profit
Research & Development $2.329M $20.03M $2.208M
YoY Change 81.1% 1933.3% 100.91%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $2.329M $20.03M $2.208M
YoY Change 81.1% 1933.3% 100.91%
Operating Profit -$3.623M -$21.29M -$4.004M
YoY Change 63.94% 856.24% 78.11%
Interest Expense $87.00K $16.00K $3.000K
YoY Change 4250.0% 300.0% 0.0%
% of Operating Profit
Other Income/Expense, Net -$835.0K -$862.0K $309.0K
YoY Change 148.51% 467.11% -347.2%
Pretax Income -$4.458M -$22.15M -$3.695M
YoY Change 75.1% 831.37% 55.71%
Income Tax -$56.00K -$18.00K -$29.00K
% Of Pretax Income
Net Earnings -$4.402M -$22.13M -$3.666M
YoY Change 105.51% 912.35% 62.43%
Net Earnings / Revenue
Basic Earnings Per Share -$0.21 -$1.51 -$0.27
Diluted Earnings Per Share -$211.8K -$1.510M -$272.7K
COMMON SHARES
Basic Shares Outstanding 20.77M 14.65M 13.45M
Diluted Shares Outstanding

Balance Sheet

Concept 2022 Q3 2022 Q2 2022 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $941.0K $2.530M $7.386M
YoY Change -93.31% -60.5% -8.81%
Cash & Equivalents $900.0K $2.500M $7.400M
Short-Term Investments
Other Short-Term Assets $779.0K $567.0K $182.0K
YoY Change 560.17% 170.0% -41.29%
Inventory
Prepaid Expenses $779.0K $567.0K $182.0K
Receivables
Other Receivables
Total Short-Term Assets $1.766M $3.456M $7.933M
YoY Change -88.03% -52.27% -10.25%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.101M $3.101M $3.155M
YoY Change 5750.94% 5538.18% 5636.36%
Total Long-Term Assets $3.101M $3.101M $3.155M
YoY Change 5750.94% 5538.18% 5636.36%
TOTAL ASSETS
Total Short-Term Assets $1.766M $3.456M $7.933M
Total Long-Term Assets $3.101M $3.101M $3.155M
Total Assets $4.867M $6.557M $11.09M
YoY Change -67.12% -10.12% 24.67%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.394M $3.211M $3.986M
YoY Change 577.64% 311.14% 409.72%
Accrued Expenses $758.0K $1.274M $521.0K
YoY Change 39.59% 108.17% -1.33%
Deferred Revenue
YoY Change
Short-Term Debt $650.0K $650.0K $0.00
YoY Change
Long-Term Debt Due $1.000M $1.000M
YoY Change
Total Short-Term Liabilities $7.952M $6.201M $4.507M
YoY Change 493.88% 345.15% 244.05%
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 $7.952M $6.201M $4.507M
Total Long-Term Liabilities $5.194M $5.194M $0.00
Total Liabilities $13.15M $11.40M $4.507M
YoY Change 881.78% 718.02% 244.05%
SHAREHOLDERS EQUITY
Retained Earnings -$86.40M -$82.00M -$59.80M
YoY Change 64.26% 62.38% 23.85%
Common Stock $21.00K $21.00K $13.00K
YoY Change 61.54% 110.0% 30.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$8.300M -$4.800M $6.581M
YoY Change
Total Liabilities & Shareholders Equity $4.867M $6.557M $11.09M
YoY Change -67.12% -10.12% 24.67%

Cashflow Statement

Concept 2022 Q3 2022 Q2 2022 Q1
OPERATING ACTIVITIES
Net Income -$4.402M -$22.13M -$3.666M
YoY Change 105.51% 912.35% 62.43%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities -$1.593M -$4.201M -$4.500M
YoY Change 14.94% 148.73% 129.01%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities -$1.000K -$655.0K
YoY Change
Cash From Investing Activities -$1.000K -$655.0K
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 5.000K 0.000 $0.00
YoY Change -99.94% -100.0% -100.0%
NET CHANGE
Cash From Operating Activities -1.593M -4.201M -$4.500M
Cash From Investing Activities -1.000K -655.0K
Cash From Financing Activities 5.000K 0.000 $0.00
Net Change In Cash -1.589M -4.856M -$4.481M
YoY Change -120.73% 187.85% 384.96%
FREE CASH FLOW
Cash From Operating Activities -$1.593M -$4.201M -$4.500M
Capital Expenditures
Free Cash Flow
YoY Change

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PaymentsToAcquireDepositsInvestingActivities
-0 usd
us-gaap Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
2483000 usd
us-gaap Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
484000 usd
us-gaap Increase Decrease In Accrued Liabilities
IncreaseDecreaseInAccruedLiabilities
-931000 usd
us-gaap Increase Decrease In Accrued Liabilities
IncreaseDecreaseInAccruedLiabilities
-194000 usd
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-8680000 usd
CY2022Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
2530000 usd
CY2021Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
6405000 usd
us-gaap Interest Paid Net
InterestPaidNet
7000 usd
us-gaap Interest Paid Net
InterestPaidNet
7000 usd
CY2022Q2 pbla Number Of Subsidiaries
NumberOfSubsidiaries
3 pure
us-gaap Nature Of Operations
NatureOfOperations
<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b><em style="font: inherit;">2.</em></b>         <b>Risks and Uncertainties</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 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 expenditures.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <p style="font-family: &quot;Times New Roman&quot;; font-size: 10pt; font-variant: normal; margin: 0pt; text-align: justify;">We have incurred losses of $82.0 million since our inception in <em style="font: inherit;">2011.</em> For the <em style="font: inherit;">six</em> months ended <em style="font: inherit;"> June 30, 2022, </em>we incurred a net loss of $25.8 million. Included in the net loss for the <em style="font: inherit;">six</em> months ended <em style="font: inherit;"> June 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 $8.7 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;"> June 30, 2022, </em>we had cash of $2.5 million, negative working capital of $2.7 million (current assets less current liabilities), and stockholders’ deficit of $4.8 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 additionally 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;">second</em> quarter of <em style="font: inherit;">2022,</em> infection rates were decreasing. 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>
CY2022Q2 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-82000000.0 usd
us-gaap Net Income Loss
NetIncomeLoss
-25800000 usd
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-8700000 usd
CY2022Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
2500000 usd
CY2022Q2 pbla Working Capital
WorkingCapital
2700000 usd
CY2022Q2 us-gaap Stockholders Equity
StockholdersEquity
-4800000 usd
us-gaap Use Of Estimates
UseOfEstimates
<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
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
9488451
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
7562992
CY2022Q2 pbla License Agreement Milestone Payments Achievement
LicenseAgreementMilestonePaymentsAchievement
90000 usd
CY2022Q2 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
11508227
CY2022Q2 pbla Shares Reserved For Issuance Weighted Average Exercise Price
SharesReservedForIssuanceWeightedAverageExercisePrice
4.56
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
627000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
616000 usd
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
5.76
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
-0
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
CY2022Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Number Of Shares Available For Grant
ShareBasedCompensationArrangementByShareBasedPaymentAwardNumberOfSharesAvailableForGrant
4040890
CY2022Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
3.62
CY2022Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
624573 usd
CY2022Q2 us-gaap Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Number Of Outstanding Options
ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfOutstandingOptions
4040890
us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Outstanding Options Weighted Average Remaining Contractual Term2
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageRemainingContractualTerm2
P7Y1M24D
CY2022Q2 us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Outstanding Options Weighted Average Exercise Price Beginning Balance1
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeOutstandingOptionsWeightedAverageExercisePriceBeginningBalance1
3.622
CY2022Q2 us-gaap Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Number Of Exercisable Options
ShareBasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeNumberOfExercisableOptions
3589307
us-gaap Sharebased Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Exercisable Options Weighted Average Remaining Contractual Term2
SharebasedCompensationSharesAuthorizedUnderStockOptionPlansExercisePriceRangeExercisableOptionsWeightedAverageRemainingContractualTerm2
P6Y9M25D

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