2021 Q4 Form 10-Q Financial Statement

#000095017021003160 Filed on November 05, 2021

View on sec.gov

Income Statement

Concept 2021 Q4 2021 Q3 2020 Q3
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $14.19M $12.44M $6.720M
YoY Change 63.89% 85.15%
% of Gross Profit
Research & Development $41.60M $33.06M $17.18M
YoY Change 148.23% 92.42% 203.84%
% of Gross Profit
Depreciation & Amortization $94.00K $44.00K $20.00K
YoY Change 840.0% 120.0%
% of Gross Profit
Operating Expenses $55.80M $45.50M $23.90M
YoY Change 119.5% 90.39% 181.91%
Operating Profit -$45.50M -$23.90M
YoY Change 90.39% 181.91%
Interest Expense $82.00K $253.0K $110.0K
YoY Change -86.33% 130.0%
% of Operating Profit
Other Income/Expense, Net -$1.220M -$259.0K $174.0K
YoY Change 221.05% -248.85% -59.25%
Pretax Income -$56.93M -$45.51M -$23.61M
YoY Change 125.93% 92.76%
Income Tax $1.007M
% Of Pretax Income
Net Earnings -$57.94M -$45.50M -$23.60M
YoY Change 129.92% 92.8% 224.62%
Net Earnings / Revenue
Basic Earnings Per Share -$0.72
Diluted Earnings Per Share -$914.4K -$722.8K -$382.9K
COMMON SHARES
Basic Shares Outstanding 65.14M 65.12M 21.57M
Diluted Shares Outstanding 62.96M

Balance Sheet

Concept 2021 Q4 2021 Q3 2020 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $248.1M $275.9M $378.5M
YoY Change -30.37% -27.12%
Cash & Equivalents $201.7M $243.2M $142.3M
Short-Term Investments $46.46M $32.65M $236.2M
Other Short-Term Assets $5.178M $5.880M $4.900M
YoY Change 15.07% 20.0%
Inventory
Prepaid Expenses
Receivables $200.0K
Other Receivables $400.0K
Total Short-Term Assets $253.3M $281.9M $383.9M
YoY Change -29.88% -26.58%
LONG-TERM ASSETS
Property, Plant & Equipment $1.549M $1.113M $9.800M
YoY Change 90.76% -88.64%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.102M $1.206M
YoY Change
Total Long-Term Assets $33.25M $34.66M $9.800M
YoY Change 249.81% 253.65%
TOTAL ASSETS
Total Short-Term Assets $253.3M $281.9M $383.9M
Total Long-Term Assets $33.25M $34.66M $9.800M
Total Assets $286.6M $316.5M $393.7M
YoY Change -22.71% -19.6%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $8.361M $133.0K $1.800M
YoY Change 768.22% -92.61%
Accrued Expenses $20.15M $15.80M $11.00M
YoY Change 167.62% 43.62%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $37.85M $24.17M $13.50M
YoY Change 207.9% 79.06%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $23.48M $25.05M $6.300M
YoY Change 326.82% 297.67%
Total Long-Term Liabilities $23.48M $25.05M $6.300M
YoY Change 326.82% 297.67%
TOTAL LIABILITIES
Total Short-Term Liabilities $37.85M $24.17M $13.50M
Total Long-Term Liabilities $23.48M $25.05M $6.300M
Total Liabilities $61.33M $49.23M $19.80M
YoY Change 245.37% 148.62%
SHAREHOLDERS EQUITY
Retained Earnings -$297.1M -$239.1M
YoY Change 137.46%
Common Stock $7.000K $7.000K $7.000K
YoY Change 0.0% 0.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $225.3M $267.3M $373.9M
YoY Change
Total Liabilities & Shareholders Equity $286.6M $316.5M $393.7M
YoY Change -22.71% -19.6%

Cashflow Statement

Concept 2021 Q4 2021 Q3 2020 Q3
OPERATING ACTIVITIES
Net Income -$57.94M -$45.50M -$23.60M
YoY Change 129.92% 92.8% 224.62%
Depreciation, Depletion And Amortization $94.00K $44.00K $20.00K
YoY Change 840.0% 120.0%
Cash From Operating Activities -$28.07M -$36.44M -$18.06M
YoY Change 33.09% 101.76%
INVESTING ACTIVITIES
Capital Expenditures $370.0K -$33.00K
YoY Change -254.17%
Acquisitions
YoY Change
Other Investing Activities -$13.89M $55.00M -$210.3M
YoY Change -743.19% -126.16%
Cash From Investing Activities -$13.52M $54.97M -$210.3M
YoY Change -804.32% -126.14%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 65.00K 167.0K 292.3M
YoY Change -118.57% -99.94%
NET CHANGE
Cash From Operating Activities -28.07M -36.44M -18.06M
Cash From Investing Activities -13.52M 54.97M -210.3M
Cash From Financing Activities 65.00K 167.0K 292.3M
Net Change In Cash -41.53M 18.70M 64.01M
YoY Change 112.74% -70.79%
FREE CASH FLOW
Cash From Operating Activities -$28.07M -$36.44M -$18.06M
Capital Expenditures $370.0K -$33.00K
Free Cash Flow -$28.44M -$36.40M
YoY Change 36.39%

Facts In Submission

Frame Concept Type Concept / XBRL Key Value Unit
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us-gaap Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
8812000
us-gaap Increase Decrease In Accounts Payable And Accrued Liabilities
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4295000
us-gaap Net Cash Provided By Used In Operating Activities
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us-gaap Net Cash Provided By Used In Operating Activities
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us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
396000
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PaymentsToAcquireAvailableForSaleSecuritiesDebt
30098000
us-gaap Payments To Acquire Available For Sale Securities Debt
PaymentsToAcquireAvailableForSaleSecuritiesDebt
242419000
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ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
230000000
us-gaap Proceeds From Maturities Prepayments And Calls Of Available For Sale Securities
ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
71000000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
199506000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
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us-gaap Payments Of Stock Issuance Costs
PaymentsOfStockIssuanceCosts
3120000
alvr Underwriting Discounts
UnderwritingDiscounts
22238000
us-gaap Proceeds From Issuance Initial Public Offering
ProceedsFromIssuanceInitialPublicOffering
295449000
us-gaap Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
167000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
167000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
292329000
us-gaap Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
EffectOfExchangeRateOnCashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
-44000
us-gaap Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
EffectOfExchangeRateOnCashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
-26000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
121378000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
81166000
CY2020Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
122661000
CY2019Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
61084000
CY2021Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
244039000
CY2020Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
142250000
alvr Unrealized Gain Loss On Available For Sale Securities
UnrealizedGainLossOnAvailableForSaleSecurities
23000
alvr Unrealized Gain Loss On Available For Sale Securities
UnrealizedGainLossOnAvailableForSaleSecurities
-83000
us-gaap Right Of Use Asset Obtained In Exchange For Operating Lease Liability
RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability
26386000
alvr Deferred Offering Costs Included In Accounts Payable And Accrued Expenses
DeferredOfferingCostsIncludedInAccountsPayableAndAccruedExpenses
356000
alvr Conversion Of Preferred Stock To Common Stock Upon Initial Public Offering
ConversionOfPreferredStockToCommonStockUponInitialPublicOffering
173127000
CY2021Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
243187000
CY2020Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
142250000
CY2021Q3 us-gaap Restricted Cash
RestrictedCash
852000
CY2021Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
244039000
CY2020Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
142250000
us-gaap Nature Of Operations
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<p style="text-indent:0.0%;font-size:10.0pt;margin-top:12.0pt;line-height:1.2458333333333333;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;">1. Nature of the Business</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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 13 different devastating viruses. The most advanced is posoleucel (previously referred to as Viralym-M or ALVR105), 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.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">The Company’s lead product candidate, posoleucel, is a multi-VST-cell therapy that targets six viruses: BK virus, JC virus, cytomegalovirus, adenovirus, Epstein-Barr virus and human herpesvirus 6. We are prioritizing prevention and treatment programs with the largest potential to transform transplant patient care and outcomes. We are focusing on key areas where there are limited or no options, including the treatment or prevention of life-threatening viral diseases caused by six devastating viruses with a single therapy. Based on progress and preliminary data, we are prioritizing our multi-virus prevention program in allogeneic HSCT patients; the aim is to improve clinical outcomes by intervening before viral infections occur and to prevent end organ damage. If proven safe and effective, this approach has the potential to be transformative as, if successful, the use of posoleucel could supplant the need for potentially toxic treatments for CMV and other viruses in HSCT patients. Given the potential advantages of the prevention approach, we therefore have elected to delay the initiation of the planned Phase 3 CMV treatment trial in allogeneic HSCT patients, in order to focus resources on our highest priority studies. We also have elected to delay the initiation of a POC clinical trial for posoleucel to treat CMV in solid organ transplant (SOT) patients, given the potential read through of our ongoing multi-virus prevention study. Similarly, additional safety and efficacy data in kidney transplant patients with BK viremia will inform the potential benefit of exploring a multi-virus prevention approach in SOT patients. In addition to our ongoing programs, we plan to initiate a Phase 3 study by the end of 2021 evaluating posoleucel for the treatment of adenovirus (AdV) in adult and pediatric allogeneic HSCT recipients. 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 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 fourth quarter 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 studied 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 early clinical data on the activity, tolerability and persistence of ALVR109 were reported in September 2021. With efficacy of available vaccine and therapies to prevent serious disease, we do not see a role for our COVID-19 therapy in a broad population. However, depending on the evolution of the SARS-CoV-2 virus, there may be a future role to treat immunocompromised patients who aren’t adequately served by available vaccines and therapies. We continue to make ALVR109 available to physicians in response to appropriate compassionate use requests, and we are monitoring the evolution of the SARS-CoV-2 virus and the COVID-19 pandemic to guide the next steps for this program in the context of our broader R&amp;D portfolio and priorities. In the preclinical space, the Company is advancing ALVR107 designed to target hepatitis B, or HBV, infected cells and cure chronic HBV infection and plan to complete preclinical IND enabling studies for ALVR107 in the fourth quarter of 2021. Lastly, we have paused our preclinical work on 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 given the declining incidence of HHV-8 associated diseases.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.2241666666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">On August 8, 2019, AlloVir formed AlloVir International Designated Activity Company (“AlloVir International”), a wholly-owned subsidiary established in Ireland.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.2241666666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">On October 9, 2019, AlloVir Securities Corporation was incorporated as a Massachusetts Security Corporation, a wholly-owned subsidiary of AlloVir.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.2241666666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">On November 10, 2019, AlloVir International formed AlloVir Italia S.R.L. (“AlloVir Italia”), a wholly-owned subsidiary in Italy.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.2241666666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">On August 3, 2020, the Company completed an initial public offering (“IPO”) in which the Company issued and sold </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">18,687,500</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> shares of its common stock, at a public offering price of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">17.00</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> per share, resulting in gross proceeds of $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">317.7</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million. The Company received $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">292.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million in net proceeds after deducting underwriting discounts and commissions and offering costs.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.2241666666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">Upon the closing of the IPO, all of the then-outstanding shares of convertible preferred stock automatically converted into </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">39,859,139</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> shares of common stock at the applicable conversion ratio then in effect. Subsequent to the closing of the IPO, there were </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">no</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> shares of convertible preferred stock outstanding.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.2241666666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">On July 20, 2021 AlloVir Inc formed AlloVir U.S., Inc. (“AlloVir U.S.”), a wholly-owned subsidiary of AlloVir.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"><br/></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;">ElevateBio, LLC</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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 have previously or currently serve in similar management roles with AlloVir. In May 2021, Diana M. Brainard M.D., succeeded David Hallal, ElevateBio's Chief Executive Officer, as the Company’s Chief Executive Officer and principal executive officer.</span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.1429166666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;">Going Concern</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.1429166666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">In accordance with Accounting Standards Update (“ASU”) 2014-15,</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;font-style:italic;"> Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40)</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">, 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.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.1429166666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.1429166666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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 September 30, 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 $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">45.5</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million and $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">23.6</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million for the three months ended September 30, 2021 and 2020, respectively, and $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">114.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million and $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">44.6</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million for the nine months ended September 30, 2021 and 2020, respectively. In addition, at September 30, 2021, the Company had an accumulated deficit of $</span><span style="font-size:10.0pt;font-family:Times New Roman;white-space:pre-wrap;font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">239.1</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million. The Company expects to continue to generate operating losses for the foreseeable future.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.1429166666666668;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">The Company believes that its $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">243.2</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million of cash and cash equivalents and $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">32.7</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> million of short-term investments held at September 30, 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.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.1700000000000002;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;">COVID-19 Considerations</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;font-style:italic;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:12.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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. For the health and safety of our employees, the Company has implemented work-at-home policies and we have generally restricted on site staff to only those employees who are fully vaccinated or essential to the development and research of product candidates; 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.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.3;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;">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.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;"> </span></p>
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us-gaap Earnings Per Share Basic And Diluted
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CY2021Q3 us-gaap Earnings Per Share Basic And Diluted
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CY2020Q3 us-gaap Earnings Per Share Basic And Diluted
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us-gaap Earnings Per Share Basic And Diluted
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us-gaap Weighted Average Number Of Share Outstanding Basic And Diluted
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0000950170-21-003160.txt Edgar Link pending
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alvr-20210930.htm Edgar Link pending
alvr-20210930.xsd Edgar Link pending
alvr-20210930_cal.xml Edgar Link unprocessable
alvr-20210930_def.xml Edgar Link unprocessable
alvr-20210930_htm.xml Edgar Link completed
alvr-20210930_lab.xml Edgar Link unprocessable
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alvr-ex31_2.htm Edgar Link pending
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alvr-ex32_2.htm Edgar Link pending
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