2022 Q3 Form 10-Q Financial Statement

#000095017022014726 Filed on August 04, 2022

View on sec.gov

Income Statement

Concept 2022 Q3 2022 Q2 2022 Q1
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $12.95M $13.25M $14.13M
YoY Change 4.05% 10.58% 34.92%
% of Gross Profit
Research & Development $30.00M $31.38M $29.07M
YoY Change -9.25% 22.21% 42.53%
% of Gross Profit
Depreciation & Amortization $85.00K $86.00K $466.0K
YoY Change 93.18% 177.42% 2488.89%
% of Gross Profit
Operating Expenses $42.95M $44.62M $43.19M
YoY Change -5.61% 18.51% 39.95%
Operating Profit -$42.95M -$44.62M -$43.19M
YoY Change -5.61% 18.51% 39.95%
Interest Expense $668.0K $162.0K $148.0K
YoY Change 164.03% -65.89% -70.98%
% of Operating Profit
Other Income/Expense, Net $210.0K -$27.00K -$818.0K
YoY Change -181.08% -93.38% 44.78%
Pretax Income -$42.07M -$44.49M -$43.86M
YoY Change -7.55% 18.36% 41.86%
Income Tax $0.00 $150.0K $0.00
% Of Pretax Income
Net Earnings -$42.10M -$44.60M -$43.86M
YoY Change -7.47% 18.62% 41.85%
Net Earnings / Revenue
Basic Earnings Per Share -$0.50 -$0.69 -$0.69
Diluted Earnings Per Share -$0.50 -$0.69 -$685.4K
COMMON SHARES
Basic Shares Outstanding 93.06M 64.47M 65.35M
Diluted Shares Outstanding 84.95M 64.47M 63.99M

Balance Sheet

Concept 2022 Q3 2022 Q2 2022 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $264.1M $172.7M $201.4M
YoY Change -4.26% -44.89% -40.24%
Cash & Equivalents $123.8M $71.09M $100.2M
Short-Term Investments $140.3M $101.6M $101.2M
Other Short-Term Assets $7.674M $3.753M $4.894M
YoY Change 30.51% 63.24% 122.45%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $272.0M $176.5M $206.4M
YoY Change -3.49% -44.15% -39.22%
LONG-TERM ASSETS
Property, Plant & Equipment $943.0K $997.0K $1.083M
YoY Change -15.27% -17.94% 24.63%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $734.0K $857.0K $979.0K
YoY Change -39.14% 23.84%
Total Long-Term Assets $21.66M $23.48M $24.65M
YoY Change -37.52% 104.76% 112.18%
TOTAL ASSETS
Total Short-Term Assets $272.0M $176.5M $206.4M
Total Long-Term Assets $21.66M $23.48M $24.65M
Total Assets $293.7M $200.0M $231.1M
YoY Change -7.21% -38.93% -34.22%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.889M $5.518M $4.473M
YoY Change 3575.94% 31.32% 117.45%
Accrued Expenses $13.68M $13.12M $10.08M
YoY Change -13.43% 31.48% 27.97%
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 $20.72M $21.59M $18.64M
YoY Change -14.29% 4.25% 20.25%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $19.75M $20.27M $20.78M
YoY Change -21.16% 367.7% 284.74%
Total Long-Term Liabilities $19.75M $20.27M $20.78M
YoY Change -21.16% 367.7% 284.74%
TOTAL LIABILITIES
Total Short-Term Liabilities $20.72M $21.59M $18.64M
Total Long-Term Liabilities $19.75M $20.27M $20.78M
Total Liabilities $40.47M $41.86M $39.42M
YoY Change -17.78% 67.15% 88.48%
SHAREHOLDERS EQUITY
Retained Earnings -$427.6M -$385.6M -$385.6M
YoY Change 78.84% 99.16% 147.14%
Common Stock $9.000K $7.000K $7.000K
YoY Change 28.57% 0.0% 0.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $253.2M $158.1M $191.7M
YoY Change
Total Liabilities & Shareholders Equity $293.7M $200.0M $231.1M
YoY Change -7.21% -38.93% -34.22%

Cashflow Statement

Concept 2022 Q3 2022 Q2 2022 Q1
OPERATING ACTIVITIES
Net Income -$42.10M -$44.60M -$43.86M
YoY Change -7.47% 18.62% 41.85%
Depreciation, Depletion And Amortization $85.00K $86.00K $466.0K
YoY Change 93.18% 177.42% 2488.89%
Cash From Operating Activities -$35.13M -$28.88M -$46.48M
YoY Change -3.6% 26.19% 145.57%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 $0.00
YoY Change -100.0% -100.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities -$38.56M -$479.0K -$54.98M
YoY Change -170.1% -100.6% -184.71%
Cash From Investing Activities -$38.56M -$479.0K -$54.98M
YoY Change -170.15% -100.6% -184.81%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 126.4M 244.0K 0.000
YoY Change 75603.59%
NET CHANGE
Cash From Operating Activities -35.13M -28.88M -46.48M
Cash From Investing Activities -38.56M -479.0K -54.98M
Cash From Financing Activities 126.4M 244.0K 0.000
Net Change In Cash 52.74M -29.11M -101.5M
YoY Change 182.08% -151.23% -320.63%
FREE CASH FLOW
Cash From Operating Activities -$35.13M -$28.88M -$46.48M
Capital Expenditures $0.00 $0.00 $0.00
Free Cash Flow -$35.13M -$28.88M -$46.48M
YoY Change -3.51% 27.77% 144.6%

Facts In Submission

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ShareBasedCompensation
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us-gaap Share Based Compensation
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17829000
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41000
us-gaap Increase Decrease In Accrued Interest Receivable Net
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-41000
us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
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-1423000
us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
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-1638000
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IncreaseDecreaseInOtherNoncurrentAssets
-245000
us-gaap Increase Decrease In Other Noncurrent Assets
IncreaseDecreaseInOtherNoncurrentAssets
692000
us-gaap Increase Decrease In Income Taxes
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-853000
us-gaap Increase Decrease In Accounts Payable And Accrued Liabilities
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-10365000
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
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us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
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us-gaap Payments To Acquire Available For Sale Securities Debt
PaymentsToAcquireAvailableForSaleSecuritiesDebt
92783000
us-gaap Payments To Acquire Available For Sale Securities Debt
PaymentsToAcquireAvailableForSaleSecuritiesDebt
30098000
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ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
37325000
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ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
175000000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
-55458000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
144539000
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ProceedsFromStockPlans
244000
us-gaap Net Cash Provided By Used In Financing Activities
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244000
us-gaap Effect Of Exchange Rate On Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
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61000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-130568000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
102786000
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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
71945000
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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
225447000
alvr Unrealized Gain Loss On Available For Sale Securities
UnrealizedGainLossOnAvailableForSaleSecurities
-289000
alvr Unrealized Gain Loss On Available For Sale Securities
UnrealizedGainLossOnAvailableForSaleSecurities
26000
us-gaap Right Of Use Asset Obtained In Exchange For Operating Lease Liability
RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability
3089000
alvr Increase Decrease In Right Of Use Asset Due To Modification
IncreaseDecreaseInRightOfUseAssetDueToModification
-5506000
alvr Purchase Of Property And Equipment Included In Accounts Payable And Accrued Expenses
PurchaseOfPropertyAndEquipmentIncludedInAccountsPayableAndAccruedExpenses
91000
us-gaap Income Taxes Paid Net
IncomeTaxesPaidNet
1003000
CY2022Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
71093000
CY2021Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
225447000
CY2022Q2 us-gaap Restricted Cash
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CY2022Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
71945000
CY2021Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
225447000
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:1.1020833333333333;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;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;min-width:fit-content;">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. The Company is developing four innovative, allogeneic, off-the-shelf VST therapy candidates targeting 12 different devastating viruses. The Company's lead product, posoleucel (previously referred to as Viralym-M or ALVR105), is a multi-VST therapy that targets six viruses: adenovirus, or AdV, BK virus, or BKV, cytomegalovirus, or CMV, Epstein-Barr virus, or EBV, human herpesvirus 6, or HHV-6 and JC virus, or JCV. The Company believes that posoleucel has the potential to fundamentally transform the treatment landscape for transplant patients by substantially reducing or preventing disease morbidity and mortality, thereby dramatically improving patient outcomes.</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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;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;min-width:fit-content;">To fully explore the clinical benefit of posoleucel, the Company is conducting three Phase 3 pivotal and two Phase 2 proof-of-concept (“POC”) trials in 2022 for the treatment and prevention of life-threatening viral diseases in pediatric and/or adult allogeneic hematopoietic cell transplant, or HCT, patients, each representing a potential meaningful commercial opportunity. The three ongoing pivotal trials evaluate the efficacy and safety of posoleucel for the treatment of virus-associated hemorrhagic cystitis, or HC, for the treatment of AdV infections and for the prevention of infections and disease caused by posoleucel’s six target viruses, respectively. A Phase 2 clinical trial for multi-virus prevention in HCT has completed enrollment and final data is expected by year-end. A second Phase 2 trial evaluating posoleucel for BKV treatment in kidney transplant patients has completed enrollment and final data is expected in the first quarter of 2023. The BKV trial is the first posoleucel study in solid organ transplant patients.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;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;min-width:fit-content;">The Company’s pipeline includes additional investigational VST therapies that may benefit high-risk individuals. ALVR106 is the Company’s second off-the-shelf, multi-VST product candidate targeting devastating respiratory diseases caused by human metapneumovirus, or hMPV, influenza, parainfluenza virus, or PIV and respiratory syncytial virus, or RSV. A Phase 1b/2 POC clinical study of ALVR106 initiated at the end of 2021. In the preclinical space, the Company is advancing ALVR107 designed to target hepatitis B, or HBV, infected cells and with the aim of curing chronic HBV infection. Preclinical and IND-enabling studies of ALVR107 to treat and cure HBV are expected to be completed in 2022 to support advancement into a POC study. ALVR109 is an allogeneic, off-the-shelf, single virus-targeted cell therapy designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. Data from the POC clinical trial of ALVR109 were reported in 2021, and the Company continues to make ALVR109 available to physicians in response to appropriate compassionate use requests.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;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;min-width:fit-content;">The Company was formed on August 16, 2013 as a Delaware limited liability company (“LLC”)</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;text-decoration:underline;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">,</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;min-width:fit-content;"> 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 Waltham, Massachusetts and Houston, Texas.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0829166666666667;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0829166666666667;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0829166666666667;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0829166666666667;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;min-width:fit-content;">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;min-width:fit-content;">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;min-width:fit-content;"> 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;min-width:fit-content;">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;min-width:fit-content;"> 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;min-width:fit-content;">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;min-width:fit-content;"> 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;min-width:fit-content;">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;min-width:fit-content;"> 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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0829166666666667;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;min-width:fit-content;">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;min-width:fit-content;">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;min-width:fit-content;"> 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;min-width:fit-content;">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;min-width:fit-content;"> shares of convertible preferred stock outstanding.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0829166666666667;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;min-width:fit-content;">On July 20, 2021, AlloVir Inc. formed AlloVir U.S., Inc. (“AlloVir U.S.”), a wholly-owned subsidiary of AlloVir.</span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.0829166666666667;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;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;min-width:fit-content;">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 Waltham, 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:1.0110416666666666;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.0110416666666666;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;min-width:fit-content;">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;min-width:fit-content;"> 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;min-width:fit-content;">, 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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0110416666666666;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0110416666666666;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;min-width:fit-content;">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 June 30, 2022, 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;min-width:fit-content;">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;min-width:fit-content;"> 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;min-width:fit-content;">37.6</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;min-width:fit-content;"> million for the three months ended June 30, 2022 and 2021, 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;min-width:fit-content;">88.5</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;min-width:fit-content;"> 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;min-width:fit-content;">68.5</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;min-width:fit-content;"> million for the six months ended June 30, 2022 and 2021, respectively. In addition, at June 30, 2022, the Company had an accumulated deficit 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;min-width:fit-content;">385.6</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;min-width:fit-content;"> 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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.0110416666666666;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;min-width:fit-content;">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;min-width:fit-content;">172.7</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;min-width:fit-content;"> million of cash, cash equivalents and short-term investments held at June 30, 2022, </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;min-width:fit-content;">combined with aggregate net 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;min-width:fit-content;">126.5</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;min-width:fit-content;"> million received under the Securities Purchase Agreement entered into on July 26, 2022 (see "Note 12 - Subsequent Events"), are </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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;line-height:1.035;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;min-width:fit-content;">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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;line-height:1.15;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;min-width:fit-content;">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 (“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;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:12.0pt;line-height:1.15;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;min-width:fit-content;">The </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;min-width:fit-content;">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</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;min-width:fit-content;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:12.0pt;line-height:1.15;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;min-width:fit-content;">providers, </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;min-width:fit-content;">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;min-width:fit-content;"> </span></p>
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CY2021Q2 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.60
CY2021Q2 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.60
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-1.38
us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-1.38
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-1.10
us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-1.10
CY2022Q2 us-gaap Management Fee Expense
ManagementFeeExpense
100000
CY2021Q2 us-gaap Management Fee Expense
ManagementFeeExpense
100000
us-gaap Management Fee Expense
ManagementFeeExpense
300000
us-gaap Management Fee Expense
ManagementFeeExpense
300000

Files In Submission

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0000950170-22-014726.txt Edgar Link pending
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alvr-20220630.htm Edgar Link pending
alvr-20220630.xsd Edgar Link pending
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alvr-20220630_def.xml Edgar Link unprocessable
alvr-20220630_htm.xml Edgar Link completed
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