2024 Q4 Form 10-Q Financial Statement
#000143774924033944 Filed on November 07, 2024
Income Statement
Concept | 2024 Q4 | 2024 Q3 | 2023 Q3 |
---|---|---|---|
Revenue | $0.00 | $0.00 | |
YoY Change | |||
Cost Of Revenue | |||
YoY Change | |||
Gross Profit | |||
YoY Change | |||
Gross Profit Margin | |||
Selling, General & Admin | $12.95M | $4.280M | |
YoY Change | 202.5% | 51.83% | |
% of Gross Profit | |||
Research & Development | $17.68M | $23.60M | |
YoY Change | -25.11% | 27.4% | |
% of Gross Profit | |||
Depreciation & Amortization | $228.0K | $273.0K | |
YoY Change | -16.48% | 50.83% | |
% of Gross Profit | |||
Operating Expenses | $30.62M | $27.88M | |
YoY Change | 9.84% | 30.61% | |
Operating Profit | -$30.62M | -$27.88M | |
YoY Change | 9.84% | 30.61% | |
Interest Expense | $2.618M | $2.005M | |
YoY Change | 30.57% | 128.36% | |
% of Operating Profit | |||
Other Income/Expense, Net | $62.00K | $223.0K | |
YoY Change | -72.2% | 6.19% | |
Pretax Income | -$27.94M | -$25.65M | |
YoY Change | 8.94% | 26.62% | |
Income Tax | $0.00 | $0.00 | |
% Of Pretax Income | |||
Net Earnings | -$27.94M | -$25.65M | |
YoY Change | 8.94% | 26.63% | |
Net Earnings / Revenue | |||
Basic Earnings Per Share | -$0.58 | -$0.61 | |
Diluted Earnings Per Share | -$0.58 | -$0.61 | |
COMMON SHARES | |||
Basic Shares Outstanding | 48.11M | 47.98M | 41.97M |
Diluted Shares Outstanding | 47.98M | 42.00M |
Balance Sheet
Concept | 2024 Q4 | 2024 Q3 | 2023 Q3 |
---|---|---|---|
SHORT-TERM ASSETS | |||
Cash & Short-Term Investments | $149.0M | $142.4M | |
YoY Change | 4.62% | -18.47% | |
Cash & Equivalents | $149.0M | $142.4M | |
Short-Term Investments | |||
Other Short-Term Assets | $192.0K | $189.0K | |
YoY Change | 1.59% | -97.8% | |
Inventory | |||
Prepaid Expenses | |||
Receivables | $1.275M | $1.300M | |
Other Receivables | $0.00 | $0.00 | |
Total Short-Term Assets | $202.5M | $150.2M | |
YoY Change | 34.87% | -18.05% | |
LONG-TERM ASSETS | |||
Property, Plant & Equipment | $21.14M | $22.08M | |
YoY Change | -4.27% | -4.55% | |
Goodwill | |||
YoY Change | |||
Intangibles | $69.00K | $268.0K | |
YoY Change | -74.25% | -63.78% | |
Long-Term Investments | |||
YoY Change | |||
Other Assets | |||
YoY Change | |||
Total Long-Term Assets | $21.20M | $22.35M | |
YoY Change | -5.11% | -6.95% | |
TOTAL ASSETS | |||
Total Short-Term Assets | $202.5M | $150.2M | |
Total Long-Term Assets | $21.20M | $22.35M | |
Total Assets | $223.8M | $172.5M | |
YoY Change | 29.69% | -16.77% | |
SHORT-TERM LIABILITIES | |||
YoY Change | |||
Accounts Payable | $52.24M | $9.500M | |
YoY Change | 449.94% | 168.82% | |
Accrued Expenses | $4.493M | $7.500M | |
YoY Change | -40.09% | 83.11% | |
Deferred Revenue | |||
YoY Change | |||
Short-Term Debt | $0.00 | $0.00 | |
YoY Change | |||
Long-Term Debt Due | |||
YoY Change | |||
Total Short-Term Liabilities | $57.03M | $17.41M | |
YoY Change | 227.52% | 109.61% | |
LONG-TERM LIABILITIES | |||
Long-Term Debt | $0.00 | $0.00 | |
YoY Change | |||
Other Long-Term Liabilities | $80.00K | $0.00 | |
YoY Change | -100.0% | ||
Total Long-Term Liabilities | $80.00K | $0.00 | |
YoY Change | -100.0% | ||
TOTAL LIABILITIES | |||
Total Short-Term Liabilities | $57.03M | $17.41M | |
Total Long-Term Liabilities | $80.00K | $0.00 | |
Total Liabilities | $57.11M | $17.41M | |
YoY Change | 227.98% | 103.27% | |
SHAREHOLDERS EQUITY | |||
Retained Earnings | -$377.5M | -$359.9M | |
YoY Change | 4.89% | 36.12% | |
Common Stock | $48.00K | $42.00K | |
YoY Change | 14.29% | 5.0% | |
Preferred Stock | |||
YoY Change | |||
Treasury Stock (at cost) | |||
YoY Change | |||
Treasury Stock Shares | |||
Shareholders Equity | $166.6M | $155.1M | |
YoY Change | |||
Total Liabilities & Shareholders Equity | $223.8M | $172.5M | |
YoY Change | 29.69% | -16.77% |
Cashflow Statement
Concept | 2024 Q4 | 2024 Q3 | 2023 Q3 |
---|---|---|---|
OPERATING ACTIVITIES | |||
Net Income | -$27.94M | -$25.65M | |
YoY Change | 8.94% | 26.63% | |
Depreciation, Depletion And Amortization | $228.0K | $273.0K | |
YoY Change | -16.48% | 50.83% | |
Cash From Operating Activities | -$18.30M | -$26.50M | |
YoY Change | -30.96% | 22.97% | |
INVESTING ACTIVITIES | |||
Capital Expenditures | $17.00K | $0.00 | |
YoY Change | -100.0% | ||
Acquisitions | |||
YoY Change | |||
Other Investing Activities | |||
YoY Change | |||
Cash From Investing Activities | -$17.00K | $0.00 | |
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 | 0.000 | 400.0K | |
YoY Change | -100.0% | 194.12% | |
NET CHANGE | |||
Cash From Operating Activities | -18.30M | -26.50M | |
Cash From Investing Activities | -17.00K | 0.000 | |
Cash From Financing Activities | 0.000 | 400.0K | |
Net Change In Cash | -18.31M | -26.10M | |
YoY Change | -29.84% | 15.64% | |
FREE CASH FLOW | |||
Cash From Operating Activities | -$18.30M | -$26.50M | |
Capital Expenditures | $17.00K | $0.00 | |
Free Cash Flow | -$18.31M | -$26.50M | |
YoY Change | -30.89% | 29.94% |
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CY2024Q3 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
47976000 | |
CY2023Q3 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
42002000 | |
us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
46101000 | ||
us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
41845000 | ||
CY2024Q3 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.58 | |
CY2023Q3 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.61 | |
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.88 | ||
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-1.82 | ||
CY2022Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
227539000 | usd |
CY2023Q1 | us-gaap |
Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
|
64000 | usd |
CY2023Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-24271000 | usd |
CY2023Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
204005000 | usd |
CY2023Q2 | us-gaap |
Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
|
889000 | usd |
CY2023Q2 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-26376000 | usd |
CY2023Q2 | us-gaap |
Stockholders Equity
StockholdersEquity
|
179353000 | usd |
CY2023Q3 | us-gaap |
Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
|
464000 | usd |
CY2023Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-25651000 | usd |
CY2023Q3 | us-gaap |
Stockholders Equity
StockholdersEquity
|
155115000 | usd |
CY2023Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
137468000 | usd |
CY2024Q1 | us-gaap |
Adjustments To Additional Paid In Capital Warrant Issued
AdjustmentsToAdditionalPaidInCapitalWarrantIssued
|
113363000 | usd |
CY2024Q1 | sava |
Stock Issued During Period Value Warrant Exercises
StockIssuedDuringPeriodValueWarrantExercises
|
22160000 | usd |
CY2024Q1 | sava |
Adjustments To Additional Paid In Capital Derecognition Of Warrant Liabilities Upon Exercise Of Warrants
AdjustmentsToAdditionalPaidInCapitalDerecognitionOfWarrantLiabilitiesUponExerciseOfWarrants
|
4954000 | usd |
CY2024Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
25043000 | usd |
CY2024Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
78597000 | usd |
CY2024Q2 | sava |
Stock Issued During Period Value Warrant Exercises
StockIssuedDuringPeriodValueWarrantExercises
|
101392000 | usd |
CY2024Q2 | sava |
Adjustments To Additional Paid In Capital Derecognition Of Warrant Liabilities Upon Exercise Of Warrants
AdjustmentsToAdditionalPaidInCapitalDerecognitionOfWarrantLiabilitiesUponExerciseOfWarrants
|
226000 | usd |
CY2024Q2 | us-gaap |
Net Income Loss
NetIncomeLoss
|
6155000 | usd |
CY2024Q2 | us-gaap |
Stockholders Equity
StockholdersEquity
|
188974000 | usd |
CY2024Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-27943000 | usd |
CY2024Q3 | us-gaap |
Stockholders Equity
StockholdersEquity
|
166639000 | usd |
us-gaap |
Net Income Loss
NetIncomeLoss
|
3255000 | usd | |
us-gaap |
Net Income Loss
NetIncomeLoss
|
-76298000 | usd | |
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
10547000 | usd | |
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
2457000 | usd | |
us-gaap |
Fair Value Adjustment Of Warrants
FairValueAdjustmentOfWarrants
|
-108183000 | usd | |
us-gaap |
Fair Value Adjustment Of Warrants
FairValueAdjustmentOfWarrants
|
0 | usd | |
us-gaap |
Depreciation
Depreciation
|
724000 | usd | |
us-gaap |
Depreciation
Depreciation
|
817000 | usd | |
us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
148000 | usd | |
us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
357000 | usd | |
us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
5074000 | usd | |
us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
-2377000 | usd | |
sava |
Increase Decrease In Operating Lease Right Of Use Assets And Liabilities Net
IncreaseDecreaseInOperatingLeaseRightOfUseAssetsAndLiabilitiesNet
|
-0 | usd | |
sava |
Increase Decrease In Operating Lease Right Of Use Assets And Liabilities Net
IncreaseDecreaseInOperatingLeaseRightOfUseAssetsAndLiabilitiesNet
|
17000 | usd | |
us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
41671000 | usd | |
us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
5815000 | usd | |
sava |
Increase Decrease In Development Expense
IncreaseDecreaseInDevelopmentExpense
|
-494000 | usd | |
sava |
Increase Decrease In Development Expense
IncreaseDecreaseInDevelopmentExpense
|
5064000 | usd | |
us-gaap |
Increase Decrease In Employee Related Liabilities
IncreaseDecreaseInEmployeeRelatedLiabilities
|
1750000 | usd | |
us-gaap |
Increase Decrease In Employee Related Liabilities
IncreaseDecreaseInEmployeeRelatedLiabilities
|
17000 | usd | |
us-gaap |
Increase Decrease In Other Operating Liabilities
IncreaseDecreaseInOtherOperatingLiabilities
|
-8000 | usd | |
us-gaap |
Increase Decrease In Other Operating Liabilities
IncreaseDecreaseInOtherOperatingLiabilities
|
-298000 | usd | |
us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-55664000 | usd | |
us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-59709000 | usd | |
us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
46000 | usd | |
us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
373000 | usd | |
us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-46000 | usd | |
us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-373000 | usd | |
us-gaap |
Proceeds From Warrant Exercises
ProceedsFromWarrantExercises
|
123552000 | usd | |
us-gaap |
Proceeds From Warrant Exercises
ProceedsFromWarrantExercises
|
0 | usd | |
us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
0 | usd | |
us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
1417000 | usd | |
us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
123552000 | usd | |
us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
1417000 | usd | |
us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Excluding Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseExcludingExchangeRateEffect
|
67842000 | usd | |
us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Excluding Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseExcludingExchangeRateEffect
|
-58665000 | usd | |
CY2023Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
121136000 | usd |
CY2022Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
201015000 | usd |
CY2024Q3 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
188978000 | usd |
CY2023Q3 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
142350000 | usd |
CY2024Q3 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
148978000 | usd |
CY2023Q3 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
142350000 | usd |
CY2024Q3 | us-gaap |
Restricted Cash Current
RestrictedCashCurrent
|
40000000 | usd |
CY2023Q3 | us-gaap |
Restricted Cash Current
RestrictedCashCurrent
|
0 | usd |
CY2024Q3 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
|
188978000 | usd |
CY2023Q3 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
|
142350000 | usd |
sava |
Issuance Of Warrants Resulting In Recognition Of Warrant Liabilities
IssuanceOfWarrantsResultingInRecognitionOfWarrantLiabilities
|
113363000 | usd | |
sava |
Issuance Of Warrants Resulting In Recognition Of Warrant Liabilities
IssuanceOfWarrantsResultingInRecognitionOfWarrantLiabilities
|
0 | usd | |
sava |
Derecognition Of Warrant Liabilities Through Exercises
DerecognitionOfWarrantLiabilitiesThroughExercises
|
-5180000 | usd | |
sava |
Derecognition Of Warrant Liabilities Through Exercises
DerecognitionOfWarrantLiabilitiesThroughExercises
|
0 | usd | |
CY2024Q3 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-377500000 | usd |
us-gaap |
Use Of Estimates
UseOfEstimates
|
<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><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;text-indent:18pt;">The Company makes estimates and assumptions in preparing its condensed consolidated financial statements in conformity with GAAP. These estimates and assumptions 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 revenue earned and expenses incurred during the reporting period. The Company evaluates its estimates on an ongoing basis, including those estimates related to common stock warrant liabilities, clinical trials and manufacturing agreements. Actual results could differ from these estimates and assumptions.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> | ||
CY2024Q1 | sava |
Class Of Warrant Or Right Fair Value Of Common Stock Warrants Per Warrant
ClassOfWarrantOrRightFairValueOfCommonStockWarrantsPerWarrant
|
6.71 | |
CY2024Q2 | sava |
Class Of Warrant Or Right Redemption Price Per Share
ClassOfWarrantOrRightRedemptionPricePerShare
|
0.001 | |
CY2024Q2 | us-gaap |
Number Of Operating Segments
NumberOfOperatingSegments
|
1 | pure |
CY2024Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-27943000 | usd |
CY2023Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-25651000 | usd |
us-gaap |
Net Income Loss
NetIncomeLoss
|
3255000 | usd | |
us-gaap |
Net Income Loss
NetIncomeLoss
|
-76298000 | usd | |
CY2024Q3 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
47976000 | |
CY2023Q3 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
42002000 | |
us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
45734000 | ||
us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
41845000 | ||
CY2024Q3 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-0.58 | |
CY2023Q3 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-0.61 | |
us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
0.07 | ||
us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-1.82 | ||
CY2024Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-27943000 | usd |
CY2023Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-25651000 | usd |
us-gaap |
Net Income Loss
NetIncomeLoss
|
3255000 | usd | |
us-gaap |
Net Income Loss
NetIncomeLoss
|
-76298000 | usd | |
CY2024Q3 | us-gaap |
Dilutive Securities
DilutiveSecurities
|
0 | usd |
CY2023Q3 | us-gaap |
Dilutive Securities
DilutiveSecurities
|
0 | usd |
us-gaap |
Dilutive Securities
DilutiveSecurities
|
-43793000 | usd | |
us-gaap |
Dilutive Securities
DilutiveSecurities
|
0 | usd | |
CY2024Q3 | us-gaap |
Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
|
-27943000 | usd |
CY2023Q3 | us-gaap |
Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
|
-25651000 | usd |
us-gaap |
Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
|
-40538000 | usd | |
us-gaap |
Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
|
-76298000 | usd | |
CY2024Q3 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
47976000 | |
CY2023Q3 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
42002000 | |
us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
45734000 | ||
us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
41845000 | ||
CY2024Q3 | us-gaap |
Weighted Average Number Diluted Shares Outstanding Adjustment
WeightedAverageNumberDilutedSharesOutstandingAdjustment
|
0 | |
CY2023Q3 | us-gaap |
Weighted Average Number Diluted Shares Outstanding Adjustment
WeightedAverageNumberDilutedSharesOutstandingAdjustment
|
0 | |
us-gaap |
Weighted Average Number Diluted Shares Outstanding Adjustment
WeightedAverageNumberDilutedSharesOutstandingAdjustment
|
367000 | ||
us-gaap |
Weighted Average Number Diluted Shares Outstanding Adjustment
WeightedAverageNumberDilutedSharesOutstandingAdjustment
|
0 | ||
CY2024Q3 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
47976000 | |
CY2023Q3 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
42002000 | |
us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
46101000 | ||
us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
41845000 | ||
CY2024Q3 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.58 | |
CY2023Q3 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.61 | |
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.88 | ||
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-1.82 | ||
CY2024Q3 | us-gaap |
Proceeds From Insurance Settlement Operating Activities
ProceedsFromInsuranceSettlementOperatingActivities
|
1100000 | usd |
CY2023Q3 | us-gaap |
Proceeds From Insurance Settlement Operating Activities
ProceedsFromInsuranceSettlementOperatingActivities
|
0 | usd |
us-gaap |
Proceeds From Insurance Settlement Operating Activities
ProceedsFromInsuranceSettlementOperatingActivities
|
9900000 | usd | |
us-gaap |
Proceeds From Insurance Settlement Operating Activities
ProceedsFromInsuranceSettlementOperatingActivities
|
100000 | usd | |
CY2024Q3 | sava |
Insurance Settlements Maximum Recovery Limit
InsuranceSettlementsMaximumRecoveryLimit
|
10000000 | usd |
sava |
Prepaid Expenses And Other Current Assets Text Bock
PrepaidExpensesAndOtherCurrentAssetsTextBock
|
<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Note <em style="font: inherit;">3.</em> Prepaid Expenses and Other Current Assets</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;text-indent:18pt;">Prepaid expenses and other current assets at <em style="font: inherit;"> September 30, 2024</em> and <em style="font: inherit;"> December 31, 2023</em> consisted of the following (in thousands):</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> <table border="0" cellpadding="0" cellspacing="0" class="finTable" style="width: 100%; font-size: 10pt; font-family: Times New Roman; text-indent: 0px;"><tbody><tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt;"> </td><td style="font-family: Times New Roman; font-size: 10pt;"> </td><td colspan="2" style="text-align: center; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;"> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b><em style="font: inherit;">September 30,</em></b></p> </td><td style="font-family: Times New Roman; font-size: 10pt;"> </td><td style="font-family: Times New Roman; font-size: 10pt;"> </td><td colspan="2" style="text-align: center; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;"> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b><em style="font: inherit;">December 31,</em></b></p> </td><td style="font-family: Times New Roman; font-size: 10pt;"> </td></tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt;"> </td><td style="font-family: Times New Roman; font-size: 10pt;"> </td><td colspan="2" style="text-align: center; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b><em style="font: inherit;">2024</em></b></p> </td><td style="font-family: Times New Roman; font-size: 10pt; padding-bottom: 1px;"> </td><td style="font-family: Times New Roman; font-size: 10pt;"> </td><td colspan="2" style="text-align: center; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b><em style="font: inherit;">2023</em></b></p> </td><td style="font-family: Times New Roman; font-size: 10pt; padding-bottom: 1px;"> </td></tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt; width: 70%;"> <p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; margin: 0pt;">Prepaid insurance</p> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;">$</td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;">1,198</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;">$</td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;">759</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;"> </td></tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt;"> <p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; margin: 0pt;">Contract research organization and other deposits</p> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;">5,906</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;">6,489</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;"> </td></tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt;"> <p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; margin: 0pt;">Interest receivable</p> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;">1,275</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt;"> </td><td style="width: 1%; font-family: "Times New Roman"; font-size: 10pt;"> </td><td style="width: 1%; font-family: "Times New Roman"; font-size: 10pt;"> </td><td style="width: 12%; font-family: "Times New Roman"; font-size: 10pt; margin-left: 0pt; text-align: right;">962</td><td style="width: 1%; font-family: "Times New Roman"; font-size: 10pt; margin-left: 0pt;"> </td></tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0"> <p style="margin: 0pt; font-size: 10pt; font-family: "Times New Roman";">Insurance recoveries</p> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0"> </td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0">5,000</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0"> </td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0">—</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding: 0; margin: 0"> </td></tr> <tr style="background-color: rgb(204, 238, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt;"> <p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; margin: 0pt;">Other</p> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);">192</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);">287</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td></tr> <tr style="background-color: rgb(255, 255, 255); vertical-align: bottom"><td style="font-family: Times New Roman; font-size: 10pt;"> <p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt 9pt;">Total prepaid expenses and other current assets</p> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">13,571</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt;"> </td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td><td style="width: 12%; text-align: right; font-family: Times New Roman; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">8,497</td><td style="width: 1%; font-family: Times New Roman; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </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;text-indent:18pt;">Contract research organization and other deposits represent cash payments made to vendors in excess of expenses incurred.</p> <p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;"> </p> | ||
CY2024Q3 | us-gaap |
Prepaid Insurance
PrepaidInsurance
|
1198000 | usd |
CY2023Q4 | us-gaap |
Prepaid Insurance
PrepaidInsurance
|
759000 | usd |
CY2024Q3 | us-gaap |
Deposit Contracts Assets
DepositContractsAssets
|
5906000 | usd |
CY2023Q4 | us-gaap |
Deposit Contracts Assets
DepositContractsAssets
|
6489000 | usd |
CY2024Q3 | us-gaap |
Interest Receivable Current
InterestReceivableCurrent
|
1275000 | usd |
CY2023Q4 | us-gaap |
Interest Receivable Current
InterestReceivableCurrent
|
962000 | usd |
CY2024Q3 | us-gaap |
Insurance Settlements Receivable Current
InsuranceSettlementsReceivableCurrent
|
5000000 | usd |
CY2023Q4 | us-gaap |
Insurance Settlements Receivable Current
InsuranceSettlementsReceivableCurrent
|
0 | usd |
CY2024Q3 | us-gaap |
Other Assets Current
OtherAssetsCurrent
|
192000 | usd |
CY2023Q4 | us-gaap |
Other Assets Current
OtherAssetsCurrent
|
287000 | usd |
CY2024Q3 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
13571000 | usd |
CY2023Q4 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
8497000 | usd |
CY2024Q3 | us-gaap |
Other Nonoperating Income
OtherNonoperatingIncome
|
288000 | usd |
CY2023Q3 | us-gaap |
Other Nonoperating Income
OtherNonoperatingIncome
|
583000 | usd |
us-gaap |
Other Nonoperating Income
OtherNonoperatingIncome
|
1005000 | usd | |
us-gaap |
Other Nonoperating Income
OtherNonoperatingIncome
|
1699000 | usd | |
CY2024Q3 | us-gaap |
Other Nonoperating Expense
OtherNonoperatingExpense
|
226000 | usd |
CY2023Q3 | us-gaap |
Other Nonoperating Expense
OtherNonoperatingExpense
|
360000 | usd |
us-gaap |
Other Nonoperating Expense
OtherNonoperatingExpense
|
684000 | usd | |
us-gaap |
Other Nonoperating Expense
OtherNonoperatingExpense
|
1083000 | usd | |
CY2024Q3 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
62000 | usd |
CY2023Q3 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
223000 | usd |
us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
321000 | usd | |
us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
616000 | usd | |
CY2024Q3 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
24143000 | usd |
CY2023Q4 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
24138000 | usd |
CY2024Q3 | us-gaap |
Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
|
3008000 | usd |
CY2023Q4 | us-gaap |
Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
|
2284000 | usd |
CY2024Q3 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
21135000 | usd |
CY2023Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
21854000 | usd |
CY2024Q3 | us-gaap |
Depreciation
Depreciation
|
228000 | usd |
CY2023Q3 | us-gaap |
Depreciation
Depreciation
|
273000 | usd |
us-gaap |
Depreciation
Depreciation
|
724000 | usd | |
us-gaap |
Depreciation
Depreciation
|
817000 | usd | |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
|
1387000 | usd |
CY2023Q4 | us-gaap |
Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
|
1346000 | usd |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
|
1318000 | usd |
CY2023Q4 | us-gaap |
Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
|
1170000 | usd |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
69000 | usd |
CY2023Q4 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
176000 | usd |
CY2024Q3 | us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
32000 | usd |
CY2023Q3 | us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
119000 | usd |
us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
148000 | usd | |
us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
357000 | usd | |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Remainder Of Fiscal Year
FiniteLivedIntangibleAssetsAmortizationExpenseRemainderOfFiscalYear
|
31000 | usd |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Next Twelve Months
FiniteLivedIntangibleAssetsAmortizationExpenseNextTwelveMonths
|
18000 | usd |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Year Two
FiniteLivedIntangibleAssetsAmortizationExpenseYearTwo
|
14000 | usd |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Year Three
FiniteLivedIntangibleAssetsAmortizationExpenseYearThree
|
6000 | usd |
CY2024Q3 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
69000 | usd |
CY2023Q4 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
|
3039029 | |
us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
|
1273000 | ||
us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
|
208000 | ||
CY2024Q3 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
|
4104029 | |
CY2024Q3 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
|
17.79 | |
CY2024Q3 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
|
P2Y1M6D | |
CY2024Q3 | us-gaap |
Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Stock Options
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions
|
45200000 | usd |
CY2023Q3 | us-gaap |
Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
|
214124 | |
CY2023Q3 | us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
464000 | usd |
us-gaap |
Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
|
495299 | ||
us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
1417000 | usd | |
CY2024Q3 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
5609000 | usd |
CY2023Q3 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
949000 | usd |
us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
10547000 | usd | |
us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
2457000 | usd | |
us-gaap |
Loss Contingency Disclosures
LossContingencyDisclosures
|
<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Note <em style="font: inherit;">11.</em> Contingencies</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 0pt 0pt -1pt; text-indent: 18pt;">The Company is, and from time to time, the Company <em style="font: inherit;"> may </em>become, involved in litigation or other legal proceedings and claims, including U.S. government inquiries, investigations and Citizen Petitions submitted to FDA. In addition, the Company has received, and from time to time <em style="font: inherit;"> may </em>receive, inquiries from government authorities relating to matters arising from the ordinary course of business. The outcome of these proceedings is inherently uncertain. Regardless of outcome, legal proceedings can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. At this time, <em style="font: inherit;">no</em> assessment can be made as to their likely outcome or whether the outcome will be material to the Company other than as disclosed below. The Company believes that its total provisions for legal matters are adequate based upon currently available information.</p> <p style="margin: 0pt 0pt 0pt -9pt; font-size: 10pt; font-family: "Times New Roman";"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -2pt;"><i>Update on Government Investigations</i></p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 25pt;">Beginning in <em style="font: inherit;"> August 2021, </em>the Company has received subpoenas, a Civil Investigative Demand (“CID”) and other requests for documents and information from the Department of Justice (“DOJ”) and document requests from the SEC, each seeking corporate information and documents concerning the research and development of simufilam and/or SavaDx. The Company has been providing documents and information in response to these subpoenas, the CID and requests for information.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 25pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -4pt; text-indent: 25pt;">On <em style="font: inherit;"> September 26, 2024, </em>the Company announced that it had reached a settlement with the SEC resolving the SEC investigation of the Company’s disclosures regarding its Phase <em style="font: inherit;">2b</em> clinical trial of simufilam for the treatment of Alzheimer’s disease (the “Phase <em style="font: inherit;">2b</em> Study”) and related matters. The SEC also agreed to a settlement with <em style="font: inherit;">two</em> former senior employees of the Company. The settlements with the Company and its former senior employees are subject to final approval by a U.S. District Court. The SEC’s complaint alleges that certain disclosures by the Company regarding the Phase <em style="font: inherit;">2b</em> Study violated certain federal securities laws and SEC rules, including negligence-based disclosure violations of Sections <em style="font: inherit;">17</em>(a)(<em style="font: inherit;">2</em>) and <em style="font: inherit;">17</em>(a)(<em style="font: inherit;">3</em>) of the Securities Act of <em style="font: inherit;">1933,</em> as amended (the “Securities Act”), as well as recordkeeping and reporting requirements under the Securities Exchange Act of <em style="font: inherit;">1934,</em> as amended (the “Exchange Act”). The complaint alleges that the Company’s SEC reports and other public statements regarding the Phase <em style="font: inherit;">2b</em> Study negligently contained materially misleading statements and omissions. The SEC’s allegations with respect to the Company’s <em style="font: inherit;">two</em> former employees relate to these employees’ roles in such disclosures. Under its settlement, the Company has consented to a permanent injunction against future violations of Section <em style="font: inherit;">17</em>(a) of the Securities Act, Section <em style="font: inherit;">13</em>(a)(<em style="font: inherit;">1</em>) of the Exchange Act and Rules <em style="font: inherit;">12b</em>-<em style="font: inherit;">20,</em> <em style="font: inherit;">13a</em>-<em style="font: inherit;">1,</em> <em style="font: inherit;">13a</em>-<em style="font: inherit;">11</em> and <em style="font: inherit;">13a</em>-<em style="font: inherit;">13</em> under the Exchange Act. In addition, the Company has agreed to pay a civil monetary penalty of <em style="font: inherit;">$40</em> million, which is classified in accounts payable and accrued expenses on its consolidated balance sheet as of <em style="font: inherit;"> September 30, 2024.</em></p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 25pt;">The Company continues to cooperate with the DOJ related to requests for documents and information, including those related to conduct alleged in the indictment of Dr. Hoau-Yan Wang announced by DOJ on <em style="font: inherit;"> June 28, 2024. </em>The Company cannot predict the outcome or impact of ongoing matters, including whether a government authority <em style="font: inherit;"> may </em>pursue an enforcement action against the Company or others. The Company does <em style="font: inherit;">not</em> at this time anticipate, however, that DOJ will bring criminal charges against or seek a criminal resolution with the Company.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt;"><i>Securities Class Actions and Shareholder Derivative Actions</i></p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">Between <em style="font: inherit;"> August 27, 2021 </em>and <em style="font: inherit;"> October 26, 2021, </em><span style="-sec-ix-hidden:c120064488">four</span> putative class action lawsuits were filed alleging violations of the federal securities laws by the Company and certain named officers. The complaints rely on allegations contained in Citizen Petitions submitted to FDA and allege that various statements made by the defendants regarding simufilam were rendered materially false and misleading. The Citizen Petitions were all subsequently denied by FDA. These actions were filed in the U.S. District Court for the Western District of Texas. The complaints seek unspecified compensatory damages and other relief on behalf of a purported class of purchasers.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">On <em style="font: inherit;"> June 30, 2022, </em>a federal judge consolidated the <span style="-sec-ix-hidden:c120064489">four</span> class action lawsuits into <span style="-sec-ix-hidden:c120064490">one</span> case and appointed a lead plaintiff and a lead counsel. Lead plaintiff filed a consolidated amended complaint on <em style="font: inherit;"> August 18, 2022 </em>on behalf of a putative class of purchasers of the Company’s securities between <em style="font: inherit;"> September 14, 2020 </em>and <em style="font: inherit;"> July 26, 2022. </em>On <em style="font: inherit;"> May 11, 2023, </em>the court dismissed with prejudice plaintiffs’ claims against defendant Nadav Friedmann, PhD, MD, our former Chief Medical Officer and a Company director, who is now deceased, but otherwise denied defendants’ motion to dismiss. Defendants filed an answer to the consolidated amended complaint on <em style="font: inherit;"> July 3, 2023. </em>On <em style="font: inherit;"> February 22, 2024, </em>plaintiffs filed a motion to supplement their complaint to extend the putative class period through <em style="font: inherit;"> October 12, 2023. </em>The court granted that Motion on <em style="font: inherit;"> June 12, 2024, </em>and plaintiffs filed a supplemental complaint on <em style="font: inherit;"> June 13, 2023. </em>On <em style="font: inherit;"> March 13, 2024, </em>plaintiffs filed a Motion for Class Certification. The Company has opposed that Motion.</p> <p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">On <em style="font: inherit;"> November 4, 2021, </em>a related shareholder derivative action was filed, purportedly on behalf of the Company, in the U.S. District Court for the Western District of Texas, asserting claims under the U.S. securities laws and state fiduciary duty laws against certain named officers and the members of the Company’s Board. This complaint relies on the allegations made in Citizen Petitions that were submitted to (and subsequently denied by) FDA. The complaint alleges, among other things, that the individual defendants exposed the Company to unspecified damages and securities law liability by causing it to make materially false and misleading statements, in violation of the U.S. securities laws and in breach of their fiduciary duties to the Company. The derivative case seeks, among other things, to recover unspecified compensatory damages on behalf of the Company arising out of the individual defendants’ alleged wrongful conduct. Although the plaintiff in this derivative case does <em style="font: inherit;">not</em> seek relief against the Company, the Company has certain indemnification obligations to the individual defendants. Between <em style="font: inherit;"> November 4, 2021 </em>and <em style="font: inherit;"> June 20, 2023, </em><span style="-sec-ix-hidden:c120064493">four</span> additional shareholder derivative actions were filed alleging substantially similar claims, <span style="-sec-ix-hidden:c120064494">two</span> in the U.S. District Court for the Western District of Texas, <span style="-sec-ix-hidden:c120064495">one</span> in Texas state court (Travis County District Court) and <span style="-sec-ix-hidden:c120064496">one</span> in the Delaware Court of Chancery. On <em style="font: inherit;"> July 5, 2022, </em>the <span style="-sec-ix-hidden:c120064497">three</span> actions in the Western District of Texas were consolidated into a single action. All of the foregoing actions are currently stayed pending further developments in the consolidated securities action described above. On <em style="font: inherit;"> November 9, 2023, </em>another shareholder derivative action alleging substantially similar claims was filed in the U.S. District Court for the Western District of Texas. The parties to that case expect that it will be consolidated into the existing consolidated federal court shareholder derivative action.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">On <em style="font: inherit;"> February 2, 2024, </em>a putative class action lawsuit was filed, purportedly on behalf of the Company, alleging violations of the federal securities law by the Company and certain named officers. The complaint relies on an <em style="font: inherit;"> October 12, 2023 </em>article that describes a purported leaked report of alleged scientific misconduct by a scientific collaborator of the Company at City University of New York. The complaint alleges that various statements made by the defendants regarding simufilam were rendered materially false and misleading by this article. The action was filed in the U.S. District Court for the Northern District of Illinois. The complaint seeks unspecified compensatory damages and other relief on behalf of a purported class of purchasers of the Company’s securities between <em style="font: inherit;"> August 18, 2022 </em>and <em style="font: inherit;"> October 12, 2023. </em>On <em style="font: inherit;"> May 28, 2024, </em>the Northern District of Illinois transferred this action to the Western District of Texas.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">Beginning on <em style="font: inherit;"> March 18, 2024, </em><span style="-sec-ix-hidden:c120064499">two</span> related shareholder derivative actions were filed, purportedly on behalf of the Company, in the U.S. District Court for the Northern District of Illinois, asserting claims under the U.S. securities laws and state fiduciary duty laws against certain named officers and the members of the Company’s Board. The complaints rely on an <em style="font: inherit;"> October 12, 2023 </em>article that describes a purported leaked report of alleged scientific misconduct by a scientific collaborator of the Company at City University of New York. The complaints allege, among other things, that the individual defendants exposed the Company to unspecified damages and securities law liability by causing it to make materially false and misleading statements, in violation of the U.S. securities laws and in breach of their fiduciary duties to the Company. The derivative cases seek, among other things, to recover unspecified compensatory damages on behalf of the Company arising out of the individual defendant’s alleged wrongful conduct. Although the plaintiffs in these derivative cases do <em style="font: inherit;">not</em> seek relief against the Company, the Company has certain indemnification obligations to the individual defendants. On <em style="font: inherit;"> September 6, 2024, </em>these <span style="-sec-ix-hidden:c120064501">two</span> cases were consolidated and stayed pending further developments in the shareholder class action initially filed in the Northern District of Illinois on <em style="font: inherit;"> February 2, 2024.</em></p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">The Company disputes the allegations and intends to defend against these lawsuits vigorously. The Company is unable to estimate the possible loss or range of loss, if any, associated with these lawsuits.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">On <em style="font: inherit;"> August 19, 2022, </em>a shareholder derivative action was filed, purportedly on behalf of the Company, in the Delaware Court of Chancery, asserting claims under state fiduciary duty laws against certain named officers and members of the Company’s Board. The complaint alleges, among other things, that the individual defendants breached their fiduciary duties by approving the CIB Plan in <em style="font: inherit;"> August 2020. </em>The complaints seek unspecified compensatory damages and other relief. On <em style="font: inherit;"> January 6, 2023, </em>the plaintiffs filed an amended complaint. Defendants filed a partial answer to the amended complaint on <em style="font: inherit;"> March 10, 2023, </em>and moved to partially dismiss the amended complaint on <em style="font: inherit;"> March 14, 2023.</em></p> <p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">On <em style="font: inherit;"> May 28, 2024, </em>the parties entered into a Stipulation and Agreement of Settlement, Compromise, and Release (the “Stipulation”) to resolve the action. The Stipulation and exhibits thereto, including the proposed Notice of Pendency of Settlement of Class and Derivative Action (the “Notice”) and [Proposed] Scheduling Order with Respect to Notice and Settlement Hearing (the “Scheduling Order”), were filed in the Delaware Court of Chancery on <em style="font: inherit;"> May 28, 2024. </em>The Stipulation is subject to final approval by the Delaware Court of Chancery. The Stipulation, if finally approved, will cause the dismissal with prejudice of the Action.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;">On <em style="font: inherit;"> June 26, 2024, </em>the Delaware Court of Chancery entered the Scheduling Order, which includes approval of the Notice. Resolution of the Action is subject to approval from the Delaware Court of Chancery. The Delaware Court of Chancery held a settlement hearing on <em style="font: inherit;"> September 9, 2024. </em>Supplemental briefing followed and the matter remains under submission.</p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt -2pt; text-indent: 18pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -1pt;"><i>Anti-SLAPP Lawsuit</i></p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -9pt;"> </p> <p style="font-family: "Times New Roman"; font-size: 10pt; font-variant: normal; margin: 0pt 0pt 0pt -1pt; text-indent: 18pt;">On <em style="font: inherit;"> August 6, 2024, </em>a lawsuit was filed in the District Court for the Southern District of New York which, as amended, asserts claims, including a claim under the New York Anti-SLAPP Law, against the Company and against two former officers to whom the Company has certain indemnification obligations. The amended complaint seeks costs and damages relating to a defamation action filed by the Company against the plaintiffs and subsequently dismissed voluntarily and without prejudice by the Company. The Company will defend the lawsuit vigorously. The Company is unable to estimate the possible loss or range of loss, if any, associated with this lawsuit.</p> | ||
CY2024Q1 | us-gaap |
Class Of Warrant Or Right Outstanding
ClassOfWarrantOrRightOutstanding
|
16895000 | |
CY2024Q1 | us-gaap |
Warrants And Rights Outstanding
WarrantsAndRightsOutstanding
|
113363000 | usd |