2021 Q1 Form 10-Q Financial Statement
#000156459021024926 Filed on May 06, 2021
Income Statement
| Concept | 2021 Q1 | 2020 Q1 |
|---|---|---|
| Revenue | $0.00 | $0.00 |
| YoY Change | -100.0% | |
| Cost Of Revenue | ||
| YoY Change | ||
| Gross Profit | ||
| YoY Change | ||
| Gross Profit Margin | ||
| Selling, General & Admin | $10.47M | $3.000M |
| YoY Change | 249.0% | 67.6% |
| % of Gross Profit | ||
| Research & Development | $20.39M | $6.839M |
| YoY Change | 198.19% | 494.7% |
| % of Gross Profit | ||
| Depreciation & Amortization | $18.00K | $18.00K |
| YoY Change | 0.0% | |
| % of Gross Profit | ||
| Operating Expenses | $30.86M | $9.840M |
| YoY Change | 213.65% | 234.69% |
| Operating Profit | -$30.86M | -$9.840M |
| YoY Change | 213.65% | |
| Interest Expense | $510.0K | $460.0K |
| YoY Change | 10.87% | 283.33% |
| % of Operating Profit | ||
| Other Income/Expense, Net | -$565.0K | $44.00K |
| YoY Change | -1384.09% | -66.15% |
| Pretax Income | -$30.92M | -$9.340M |
| YoY Change | 231.05% | 270.63% |
| Income Tax | $0.00 | |
| % Of Pretax Income | ||
| Net Earnings | -$30.92M | -$9.339M |
| YoY Change | 231.12% | 270.01% |
| Net Earnings / Revenue | ||
| Basic Earnings Per Share | ||
| Diluted Earnings Per Share | -$497.2K | -$135.0K |
| COMMON SHARES | ||
| Basic Shares Outstanding | 65.11M | |
| Diluted Shares Outstanding |
Balance Sheet
| Concept | 2021 Q1 | 2020 Q1 |
|---|---|---|
| SHORT-TERM ASSETS | ||
| Cash & Short-Term Investments | $337.0M | $336.9M |
| YoY Change | 0.03% | |
| Cash & Equivalents | $168.6M | $168.6M |
| Short-Term Investments | $168.3M | $168.3M |
| Other Short-Term Assets | $2.200M | $1.000M |
| YoY Change | 120.0% | |
| Inventory | ||
| Prepaid Expenses | ||
| Receivables | $300.0K | |
| Other Receivables | $400.0K | |
| Total Short-Term Assets | $339.7M | $117.4M |
| YoY Change | 189.32% | |
| LONG-TERM ASSETS | ||
| Property, Plant & Equipment | $869.0K | $11.30M |
| YoY Change | -92.31% | |
| Goodwill | ||
| YoY Change | ||
| Intangibles | ||
| YoY Change | ||
| Long-Term Investments | ||
| YoY Change | ||
| Other Assets | ||
| YoY Change | ||
| Total Long-Term Assets | $11.62M | $11.30M |
| YoY Change | 2.81% | |
| TOTAL ASSETS | ||
| Total Short-Term Assets | $339.7M | $117.4M |
| Total Long-Term Assets | $11.62M | $11.30M |
| Total Assets | $351.3M | $128.7M |
| YoY Change | 172.95% | |
| SHORT-TERM LIABILITIES | ||
| YoY Change | ||
| Accounts Payable | $2.057M | $1.800M |
| YoY Change | 14.28% | |
| Accrued Expenses | $7.879M | $5.400M |
| YoY Change | 45.91% | |
| Deferred Revenue | ||
| YoY Change | ||
| Short-Term Debt | $0.00 | $0.00 |
| YoY Change | ||
| Long-Term Debt Due | ||
| YoY Change | ||
| Total Short-Term Liabilities | $15.50M | $7.700M |
| YoY Change | 101.3% | |
| LONG-TERM LIABILITIES | ||
| Long-Term Debt | $0.00 | $0.00 |
| YoY Change | ||
| Other Long-Term Liabilities | $5.400M | $7.900M |
| YoY Change | -31.65% | |
| Total Long-Term Liabilities | $5.400M | $7.900M |
| YoY Change | -31.65% | |
| TOTAL LIABILITIES | ||
| Total Short-Term Liabilities | $15.50M | $7.700M |
| Total Long-Term Liabilities | $5.400M | $7.900M |
| Total Liabilities | $20.91M | $15.60M |
| YoY Change | 34.05% | |
| SHAREHOLDERS EQUITY | ||
| Retained Earnings | -$156.0M | |
| YoY Change | ||
| Common Stock | $7.000K | |
| YoY Change | ||
| Preferred Stock | ||
| YoY Change | ||
| Treasury Stock (at cost) | ||
| YoY Change | ||
| Treasury Stock Shares | ||
| Shareholders Equity | $330.4M | -$60.02M |
| YoY Change | ||
| Total Liabilities & Shareholders Equity | $351.3M | $128.7M |
| YoY Change | 172.95% |
Cashflow Statement
| Concept | 2021 Q1 | 2020 Q1 |
|---|---|---|
| OPERATING ACTIVITIES | ||
| Net Income | -$30.92M | -$9.339M |
| YoY Change | 231.12% | 270.01% |
| Depreciation, Depletion And Amortization | $18.00K | $18.00K |
| YoY Change | 0.0% | |
| Cash From Operating Activities | -$18.93M | -$10.54M |
| YoY Change | 79.51% | 432.47% |
| INVESTING ACTIVITIES | ||
| Capital Expenditures | $75.00K | $0.00 |
| YoY Change | ||
| Acquisitions | ||
| YoY Change | ||
| Other Investing Activities | $64.90M | $13.84M |
| YoY Change | 368.93% | |
| Cash From Investing Activities | $64.83M | $13.84M |
| YoY Change | 368.44% | |
| 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 | |
| YoY Change | -100.0% | |
| NET CHANGE | ||
| Cash From Operating Activities | -18.93M | -10.54M |
| Cash From Investing Activities | 64.83M | 13.84M |
| Cash From Financing Activities | 0.000 | |
| Net Change In Cash | 45.98M | 3.296M |
| YoY Change | 1295.15% | -263.98% |
| FREE CASH FLOW | ||
| Cash From Operating Activities | -$18.93M | -$10.54M |
| Capital Expenditures | $75.00K | $0.00 |
| Free Cash Flow | -$19.00M | -$10.54M |
| YoY Change | 80.22% | 432.47% |
Facts In Submission
| Frame | Concept Type | Concept / XBRL Key | Value | Unit |
|---|---|---|---|---|
| CY2021Q1 | us-gaap |
Assets
Assets
|
351281000 | |
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Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
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2203000 | |
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Prepaid Expense And Other Assets Current
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4543000 | |
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Assets Current
AssetsCurrent
|
339664000 | |
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Assets Current
AssetsCurrent
|
361317000 | |
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Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
869000 | |
| CY2020Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
812000 | |
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Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
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10748000 | |
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Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
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8692000 | |
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Additional Paid In Capital
AdditionalPaidInCapital
|
486375000 | |
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Preferred Stock Shares Issued
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|
0 | |
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Assets
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370821000 | |
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478272000 | |
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Accumulated Other Comprehensive Income Loss Net Of Tax
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|
13000 | |
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Accumulated Other Comprehensive Income Loss Net Of Tax
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-112000 | |
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Retained Earnings Accumulated Deficit
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-156026000 | |
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Retained Earnings Accumulated Deficit
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Preferred Stock Shares Outstanding
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|
0 | |
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Accounts Payable Current
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2057000 | |
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Accounts Payable Current
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963000 | |
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Stockholders Equity
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330369000 | |
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353064000 | |
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Preferred Stock Value
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Common Stock Value
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7000 | |
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370821000 | |
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Preferred Stock Par Or Stated Value Per Share
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0.0001 | |
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0.0001 | |
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10000000 | |
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Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
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10000000 | |
| CY2021Q1 | us-gaap |
Preferred Stock Shares Issued
PreferredStockSharesIssued
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0 | |
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Accrued Liabilities Current
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7879000 | |
| CY2020Q4 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
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7530000 | |
| CY2021Q1 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
4785000 | |
| CY2020Q4 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
3229000 | |
| CY2021Q1 | us-gaap |
Due To Related Parties Current
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|
779000 | |
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Due To Related Parties Current
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572000 | |
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Operating Lease Liability Noncurrent
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Operating Lease Liability Noncurrent
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Liabilities
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20912000 | |
| CY2020Q4 | us-gaap |
Liabilities
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17757000 | |
| CY2021Q1 | us-gaap |
Preferred Stock Value
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Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
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0 | |
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Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
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0.0001 | |
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Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
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0.0001 | |
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Common Stock Shares Authorized
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Common Stock Shares Issued
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Research And Development Expense
ResearchAndDevelopmentExpense
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20393000 | |
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Research And Development Expense
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OperatingIncomeLoss
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Investment Income Interest
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Investment Income Interest
InvestmentIncomeInterest
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457000 | |
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Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
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-565000 | |
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Net Income Loss
NetIncomeLoss
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-9339000 | |
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Other Nonoperating Income Expense
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44000 | |
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Net Income Loss
NetIncomeLoss
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Payments To Acquire Available For Sale Securities Debt
PaymentsToAcquireAvailableForSaleSecuritiesDebt
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30098000 | |
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Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
|
-0.50 | |
| CY2020Q1 | us-gaap |
Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
|
-4.21 | |
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Weighted Average Number Of Share Outstanding Basic And Diluted
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62193734 | |
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Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
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2215958 | |
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Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Net Of Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodNetOfTax
|
42000 | |
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Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Net Of Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodNetOfTax
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176000 | |
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Other Comprehensive Income Loss Foreign Currency Transaction And Translation Adjustment Net Of Tax
OtherComprehensiveIncomeLossForeignCurrencyTransactionAndTranslationAdjustmentNetOfTax
|
83000 | |
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Other Comprehensive Income Loss Net Of Tax
OtherComprehensiveIncomeLossNetOfTax
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125000 | |
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Other Comprehensive Income Loss Net Of Tax
OtherComprehensiveIncomeLossNetOfTax
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176000 | |
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Comprehensive Income Net Of Tax
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Stockholders Equity
StockholdersEquity
|
-51503000 | |
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Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
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646000 | |
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Stockholders Equity
StockholdersEquity
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-60020000 | |
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Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
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8103000 | |
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Profit Loss
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Profit Loss
ProfitLoss
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-9339000 | |
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Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
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18000 | |
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Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
18000 | |
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Non Cash Lease Expense
NonCashLeaseExpense
|
54000 | |
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Amortization And Accretion Of Discounts On Short Term Investments
AmortizationAndAccretionOfDiscountsOnShortTermInvestments
|
-456000 | |
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Amortization And Accretion Of Discounts On Short Term Investments
AmortizationAndAccretionOfDiscountsOnShortTermInvestments
|
24000 | |
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Share Based Compensation
ShareBasedCompensation
|
8103000 | |
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Share Based Compensation
ShareBasedCompensation
|
646000 | |
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Increase Decrease In Unbilled Grants Receivable
IncreaseDecreaseInUnbilledGrantsReceivable
|
48000 | |
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Increase Decrease In Accrued Interest Receivable Net
IncreaseDecreaseInAccruedInterestReceivableNet
|
19000 | |
| CY2020Q1 | us-gaap |
Increase Decrease In Accrued Interest Receivable Net
IncreaseDecreaseInAccruedInterestReceivableNet
|
49000 | |
| CY2021Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
-1735000 | |
| CY2020Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
284000 | |
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Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
1650000 | |
| CY2020Q1 | us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
-1463000 | |
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Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-18926000 | |
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Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-10543000 | |
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Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
75000 | |
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Payments To Acquire Available For Sale Securities Debt
PaymentsToAcquireAvailableForSaleSecuritiesDebt
|
21161000 | |
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Proceeds From Maturities Prepayments And Calls Of Available For Sale Securities
ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
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95000000 | |
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Proceeds From Maturities Prepayments And Calls Of Available For Sale Securities
ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
|
35000000 | |
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Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
64827000 | |
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Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
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13839000 | |
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Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
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|
83000 | |
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Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
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45984000 | |
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Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
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3296000 | |
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Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
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Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
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61084000 | |
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Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
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168645000 | |
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Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
|
64380000 | |
| CY2021Q1 | alvr |
Unrealized Gain Loss On Available For Sale Securities
UnrealizedGainLossOnAvailableForSaleSecurities
|
42000 | |
| CY2020Q1 | alvr |
Unrealized Gain Loss On Available For Sale Securities
UnrealizedGainLossOnAvailableForSaleSecurities
|
176000 | |
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Right Of Use Asset Obtained In Exchange For Operating Lease Liability
RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability
|
3099000 | |
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Nature Of Operations
NatureOfOperations
|
<p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1. Nature of the Business </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">AlloVir, Inc. (“AlloVir” or “the Company”, formerly known as ViraCyte, Inc.) is a leading late clinical-stage cell therapy company developing highly innovative allogeneic T-cell therapies to treat and prevent devastating viral diseases. The Company’s innovative and proprietary virus-specific T-cell, or VST, therapy platform allows AlloVir to generate off-the-shelf VSTs designed to restore immunity in patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. There is an urgent medical need for therapies to treat a large number of patients suffering from viral diseases who currently have limited or no treatment options. To date, the Company has generated five innovative, allogeneic, off-the-shelf VST therapy candidates targeting 12 different devastating viruses. The most advanced is Viralym-M, for which the Company has an ongoing pivotal trial for the treatment of virus-associated hemorrhagic cystitis and ongoing proof-of-concept, or POC, clinical trials for multi-virus prevention in HSCT and BKV in kidney transplant.</p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company’s lead product candidate, Viralym-M, is a multi-VST-cell therapy that targets five viruses: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus and human herpesvirus 6. To fully explore the clinical benefit of Viralym-M, the Company plans to initiate an additional two Phase 3 pivotal and one Phase 2 proof-of-concept trials by the end of 2021 for the treatment and prevention of life-threatening viral diseases in pediatric and/or adult patients, each representing a potential meaningful commercial opportunity. In addition, ALVR106 is the Company’s second multi-virus-targeted off-the-shelf VST product candidate targeting devastating respiratory diseases caused by respiratory syncytial virus, or RSV, influenza, parainfluenza virus, or PIV, and human metapneumovirus, or hMPV. An Investigational New Drug, or IND, application with the <font style="color:#000000;">FDA for ALVR106 was cleared in the fourth quarter of 2020 and the Company plans to initiate a Phase 1/2 clinical study in autologous and allogeneic HSCT patients with respiratory viral diseases in the second half of 2021. Pursuant to the sponsored research agreement with Baylor College of Medicine (“BCM”), BCM initiated a proof-of-concept trial for ALVR109, an allogeneic, off-the-shelf VST therapy designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected cells. BCM initiated the POC clinical trial in the fourth quarter of 2020 and the trial is ongoing. Lastly, the Company is advancing ALVR107 designed to target hepatitis B, or HBV, infected cells and treat chronic HBV infections and ALVR108 to treat human herpesvirus-8, or HHV-8, associated diseases including Kaposi Sarcoma, or KS, primary effusion lymphoma, or PEL, and multicentric Castleman’s disease, or MCD. The Company plans to complete pre-clinical IND enabling studies for ALVR107 and ALVR108 in the second half of 2021. </font></p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company was formed on August 16, 2013 as a Delaware limited liability company (“LLC”) under the name AdCyte LLC and on July 29, 2014 the Company changed its name to ViraCyte LLC. On September 17, 2018, the Company converted from a Delaware LLC to a Delaware corporation (“LLC Conversion”) and changed its name to ViraCyte, Inc. On May 22, 2019, the Company changed its name to AlloVir, Inc. The Company has principal offices in Houston, Texas and Cambridge, Massachusetts. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On August 8, 2019, AlloVir formed AlloVir International Designated Activity Company (“AlloVir International”), a wholly-owned subsidiary established in Ireland. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On October 9, 2019, AlloVir Securities Corporation was incorporated as a Massachusetts Security Corporation, a wholly-owned subsidiary of AlloVir. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On November 10, 2019, AlloVir International formed AlloVir Italia S.R.L. (“AlloVir Italia”), a wholly-owned subsidiary in Italy. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On August 3, 2020, the Company completed an initial public offering (“IPO”) in which the Company issued and sold 18,687,500 shares of its common stock, at a public offering price of $17.00 per share, resulting in gross proceeds of $317.7 million. The Company received $292.0 million in net proceeds after deducting underwriting discounts and commissions and offering costs. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Upon the closing of the IPO, all of the then-outstanding shares of convertible preferred stock automatically converted into 39,859,139 shares of common stock at the applicable conversion ratio then in effect. Subsequent to the closing of the IPO, there were no shares of convertible preferred stock outstanding.</p> <p style="text-align:justify;margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">ElevateBio, LLC </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On September 17, 2018, the Company executed a Series A2 Preferred Stock Purchase Agreement (“Series A2 Agreement”) with ElevateBio, LLC, a Delaware LLC (“ElevateBio”) concurrent with the LLC Conversion. ElevateBio was formed on November 29, 2017 and is headquartered in Cambridge, Massachusetts with a focus on the development of a portfolio of novel cell therapy programs acquired through business development activities with biotechnology companies. ElevateBio is structured as a holding company, comprised of asset-specific subsidiaries focused on the development of pipeline assets, as well as a manufacturing subsidiary with the expertise to provide drug development and manufacturing services. As a result of the purchase of the Company’s Series A2 Preferred Stock, ElevateBio acquired an ownership interest in the Company. The Chief Executive Officer, Chief Financial Officer, and other executives of ElevateBio currently serve in similar management roles with AlloVir. On March 17, 2021, our Board of Directors appointed Diana M. Brainard M.D., as the Company’s Chief Executive Officer and principal executive officer, effective May 17, 2021.</p> <p style="text-align:justify;margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">Going Concern </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In accordance with Accounting Standards Update (“ASU”) 2014-15,<font style="font-style:italic;"> Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40)</font>, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance and reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Through March 31, 2021, the Company has funded its operations primarily with proceeds received from the sale of common stock, research grants, and from the sale of preferred stock. The Company has incurred recurring losses since its inception, including net losses attributable to common stockholders of $30.9 million and $9.3 million for the three months ended March 31, 2021 and 2020, respectively. In addition, at March 31, 2021, the Company had an accumulated deficit of $156.0 million. The Company expects to continue to generate operating losses for the foreseeable future. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company believes that its $168.6 million of cash and cash equivalents and $168.3 million of short-term investments held at March 31, 2021, are sufficient to fund planned operations for at least twelve months from the date that these condensed consolidated financial statements are available to be issued. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">COVID-19 Considerations </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The development of product candidates could be disrupted and materially adversely affected in the future by a pandemic, epidemic or outbreak of an infectious disease, such as the recent COVID-19 pandemic. The spread of COVID-19 has impacted the global economy and has impacted the Company’s operations, including the interruption of preclinical and clinical trial activities and potential interruption to the Company’s supply chain. For example, the COVID-19 pandemic has delayed clinical trials. If the disruption due to the COVID-19 pandemic continues, planned pivotal clinical trials also could be delayed due to government orders and site policies on account of the pandemic, and some patients may be unwilling or unable to travel to study sites, enroll in trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay the Company’s ability to conduct preclinical studies and clinical trials or release clinical trial results and could delay the Company’s ability to obtain regulatory approval and commercialize product candidates. Furthermore, COVID-19 could affect the Company’s employees or the employees of research sites and service providers on whom the Company relies on as well as those of companies with which the Company does business, including suppliers and contract manufacturing organizations or CMOs, thereby disrupting business operations. Quarantines and travel restrictions imposed by governments in the jurisdictions in which the Company and the companies with which it does business operate could materially impact the ability of employees to access preclinical and clinical sites, laboratories, manufacturing sites and offices. The Company has implemented work-at-home policies and only employees essential to the development and research of product candidates remain on-site at the Company’s research and manufacturing facilities; accordingly, the Company may experience limitations in employee resources. The outbreak and any other preventative or protective actions that the Company, its suppliers or other third parties with which it has business relationships, or governments may take in respect of the COVID-19 pandemic, could disrupt, delay or otherwise adversely impact the business. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is still assessing business plans and the impact the COVID-19 pandemic may have on its ability to advance the testing, development and manufacturing of drug candidates, including as a result of adverse impacts on the research sites, service providers, vendors, or suppliers on whom the Company relies on, or to raise financing to support the development of our drug candidates. No assurances can be given that this analysis will enable the Company to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or this sector in particular. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties on whom it relies on or with whom it conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct business in the manner and on the timelines presently planned could be materially and adversely impacted. </p> | |
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Lessee Operating Lease Liability Undiscounted Excess Amount
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|
558000 | |
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Operating Lease Liability
OperatingLeaseLiability
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10197000 | |
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Operating Lease Expense
OperatingLeaseExpense
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1300000 | |
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Proceeds From Issuance Initial Public Offering
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292000000 | |
| CY2020Q1 | us-gaap |
Cash And Cash Equivalents At Carrying Value
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168600000 | |
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168300000 | |
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168329000 | |
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Available For Sale Debt Securities Accumulated Gross Unrealized Gain Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedGainBeforeTax
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18000 | |
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Available For Sale Securities Debt Securities Current
AvailableForSaleSecuritiesDebtSecuritiesCurrent
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168347000 | |
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Available For Sale Debt Securities Amortized Cost Basis
AvailableForSaleDebtSecuritiesAmortizedCostBasis
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233687000 | |
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Available For Sale Debt Securities Accumulated Gross Unrealized Gain Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedGainBeforeTax
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0 | |
| CY2020Q4 | us-gaap |
Available For Sale Debt Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
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24000 | |
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Available For Sale Securities Debt Securities Current
AvailableForSaleSecuritiesDebtSecuritiesCurrent
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233663000 | |
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Cash And Cash Equivalents Fair Value Disclosure
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154895000 | |
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Cash And Cash Equivalents Fair Value Disclosure
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95503000 | |
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Lease Expiration Month And Year
LeaseExpirationMonthAndYear
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2021-09 | |
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Short Term Lease Cost
ShortTermLeaseCost
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100000 | |
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Short Term Lease Cost
ShortTermLeaseCost
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100000 | |
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Non Lease Costs Including Utilities And Cleaning
NonLeaseCostsIncludingUtilitiesAndCleaning
|
17000 | |
| CY2020Q1 | alvr |
Non Lease Costs Including Utilities And Cleaning
NonLeaseCostsIncludingUtilitiesAndCleaning
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15000 | |
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Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
|
4020000 | |
| CY2021Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
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4560000 | |
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Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
|
2175000 | |
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Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
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10755000 | |
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Operating Lease Expense
OperatingLeaseExpense
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1000000 | |
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Operating Lease Payments
OperatingLeasePayments
|
1100000 | |
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Operating Lease Payments
OperatingLeasePayments
|
1200000 | |
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Variable Non Lease Cost
VariableNonLeaseCost
|
900000 | |
| CY2020Q1 | alvr |
Variable Non Lease Cost
VariableNonLeaseCost
|
800000 | |
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Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
|
P2Y2M19D | |
| CY2021Q1 | us-gaap |
Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
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0.0476 | |
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AccruedEmployeeBenefitsCurrent
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1296000 | |
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Accrued Employee Benefits Current
AccruedEmployeeBenefitsCurrent
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3314000 | |
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AccruedProfessionalFeesCurrent
|
864000 | |
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Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
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696000 | |
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Accrued Research And Development Current
AccruedResearchAndDevelopmentCurrent
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5490000 | |
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Accrued Research And Development Current
AccruedResearchAndDevelopmentCurrent
|
3347000 | |
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Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
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229000 | |
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Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
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173000 | |
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Number Of Votes Per Share
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1 | |
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Common Stock Voting Rights
CommonStockVotingRights
|
The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders (and written actions in lieu of meetings), and there are not any cumulative voting rights. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of the holders of shares of capital stock of the Company; however, the issuance of common stock may be subject to the vote of the holders of one or more series of preferred stock that may be required by terms of the Third Amended and Restated Certificate of Incorporation | |
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Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
|
23.43 | |
| CY2021Q1 | us-gaap |
Dividends Cash
DividendsCash
|
0 | |
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Dividends Cash
DividendsCash
|
0 | |
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Common Stock Capital Shares Reserved For Future Issuance
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14015353 | |
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Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
|
11279849 | |
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Sharebased Compensation Arrangement By Sharebased Payment Award Options Nonvested Number Of Shares
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsNonvestedNumberOfShares
|
3972909 | |
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Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
|
1186138 | |
| CY2021Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
|
14000 | |
| CY2021Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Nonvested Number Of Shares
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsNonvestedNumberOfShares
|
5145047 | |
| CY2021Q1 | alvr |
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExercisableNumber
|
28009 | |
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Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
|
17.84 | |
| CY2021Q1 | us-gaap |
Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
|
42.30 | |
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Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
|
36.80 | |
| CY2021Q1 | alvr |
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExercisableWeightedAverageExercisePrice
|
6.76 | |
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Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
|
P9Y7M6D | |
| CY2021Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
|
P9Y4M24D | |
| CY2021Q1 | alvr |
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Exercisable Weighted Average Remaining Contractual Term
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExercisableWeightedAverageRemainingContractualTerm
|
P8Y9M18D | |
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Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
|
81822000 | |
| CY2021Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
|
24616000 | |
| CY2021Q1 | alvr |
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Exercisable Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExercisableIntrinsicValue
|
466000 | |
| CY2021Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
|
32.39 | |
| CY2021Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Fair Value Assumptions Expected Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1
|
P6Y1M6D | |
| CY2021Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
|
0.95 | |
| CY2021Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate
|
0.0064 | |
| CY2021Q1 | us-gaap |
Share Price
SharePrice
|
42.30 | |
| CY2021Q1 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
8103000 | |
| CY2020Q1 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
646000 | |
| CY2021Q1 | us-gaap |
Current Income Tax Expense Benefit
CurrentIncomeTaxExpenseBenefit
|
0 | |
| CY2020Q1 | us-gaap |
Current Income Tax Expense Benefit
CurrentIncomeTaxExpenseBenefit
|
0 | |
| CY2021Q1 | us-gaap |
Deferred Income Tax Expense Benefit
DeferredIncomeTaxExpenseBenefit
|
0 | |
| CY2020Q1 | us-gaap |
Deferred Income Tax Expense Benefit
DeferredIncomeTaxExpenseBenefit
|
0 | |
| CY2021Q1 | us-gaap |
Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
|
-30923000 | |
| CY2020Q1 | us-gaap |
Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
|
-9339000 | |
| CY2021Q1 | us-gaap |
Management Fee Expense
ManagementFeeExpense
|
200000 | |
| CY2020Q1 | us-gaap |
Management Fee Expense
ManagementFeeExpense
|
300000 |
