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Allovir, Inc. (ALVR) SEC Filing 10-K Annual Report for the fiscal year ending Friday, December 31, 2021

Allovir, Inc.

CIK: 1754068 Ticker: ALVR

Exhibit 99.1

 

LOGO

For Immediate Release

AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook

Three ongoing Phase 3 registrational studies of posoleucel expected in 2022, targeting treatment and

prevention indications with no approved therapies

Expanded enrollment in Phase 2 proof-of-concept study of posoleucel for the preemptive treatment of BK

viremia in kidney transplant recipients; initial data submitted for presentation in 1H 2022

Advancing two additional virus-specific T cell therapies – ALVR106 to treat common respiratory viral

infections and ALVR107 for hepatitis B cure

Strong cash position, with $248.1 million as of year-end 2021

Waltham, Mass., February 10, 2022 – AlloVir (Nasdaq: ALVR), a late clinical-stage allogeneic T cell immunotherapy company, today reported full-year 2021 financial results for the period ended December 31, 2021. The company also provided the outlook for 2022 across its pipeline of allogeneic, off-the-shelf, virus-specific T cell (VST) therapies for immunocompromised patients, including its lead product posoleucel, an investigational VST in development for the treatment and prevention of infections and diseases caused by six common devastating viruses – adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV).

“2022 is a year of execution and expansion for our clinical development program, as we implement three Phase 3 registrational studies across sites in North America, Europe and Asia, present new data that expand on posoleucel’s potential in both the treatment and prevention of six life-threatening viruses, and continue to advance two additional VST therapies,” said Diana Brainard, M.D., Chief Executive Officer of AlloVir. “Beyond our clinical development programs, we are also advancing the manufacturing of posoleucel in anticipation of commercial product requirements and global distribution. Our non-gene-edited VST manufacturing platform is commercially scalable and can achieve cost of goods similar to biologics. This positions us well for the next stage of our company’s growth as our pipeline continues to mature.”

Recent Highlights

Advancing Posoleucel Development

 

   

At the American Society of Hematology (ASH) Annual Meeting in December 2021, AlloVir reported positive preliminary data from the open-label Phase 2 study assessing the safety and efficacy of posoleucel for the prevention of multiple viruses in high-risk allogeneic hematopoietic cell transplant (allo-HCT) patients. The preliminary data set demonstrated a substantial reduction in the expected rate of clinically significant viral infections or diseases and facilitates an accelerated path to Phase 3 development, which has been agreed to in principle by the U.S. Food and Drug Administration (FDA). The Phase 3 registrational study is expected to initiate in the first half of 2022.

 

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The following information was filed by Allovir, Inc. (ALVR) on Thursday, February 10, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Allovir, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

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Inside Allovir, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Cash Flows (Parenthetical)
Consolidated Statements Of Convertible Preferred Stock And Changes In Stockholders' Equity (Deficit)
Consolidated Statements Of Operations And Comprehensive Loss
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Schedule Of Accrued Expenses (Details)
Commitments And Contingencies
Commitments And Contingencies- Additional Information (Details)
Employee Benefit Plans
Employee Benefit Plans - Additional Information (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Summary Of Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
Funding Arrangements
Funding Arrangements - Additional Information (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Schedule Of Income Tax Expense (Benefit) Reconciliation (Details)
Income Taxes - Schedule Of Provision For Income Taxes (Details)
Income Taxes - Summary Of Components Of Deferred Income Taxes (Details)
Income Taxes - Summary Of Income (Loss) Before Provision For Income Taxes (Details)
Leases
Leases (Tables)
Leases - Additional Information (Details)
Leases - Summary Of Operating Lease Liabilities (Details)
Leases - Summary Of Operating Lease Liabilities (Details) (Parenthetical)
Nature Of The Business
Nature Of The Business - Additional Information (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Computation Of Basic And Diluted Net Loss Per Share Attributable To Common Stockholders (Details)
Net Loss Per Share - Potential Dilutive Securities Excluded From Computation Of Diluted Net Loss Per Share Attributable To Common Stockholders (Details)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Additional Information (Details)
Property And Equipment, Net - Schedule Of Property And Equipment, Net (Details)
Related Party Transactions
Related Party Transactions - Additional Information (Details)
Short-Term Investments
Short-Term Investments (Tables)
Short-Term Investments - Summary Of Amortized Cost And Estimated Fair Value Of Marketable Securities (Details)
Sponsored Research, Collaboration And License Agreements
Sponsored Research, Collaboration And License Agreements - Additional Information (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Schedule Of Estimated Fair Value Weighted-Average Assumptions Using Black-Scholes Option-Pricing Model (Details)
Stock-Based Compensation - Schedule Of Stock-Based Compensation Expense (Details)
Stock-Based Compensation - Summary Of Restricted Common Stock Activity (Details)
Stock-Based Compensation - Summary Of Stock Option Activity (Details)
Stockholder's Equity
Stockholder's Equity (Tables)
Stockholders Equity - Additional Information (Details)
Stockholders Equity - Schedule Of Reserved Shares Of Common Stock For Issuance (Details)
Subsequent Events
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Schedule Of Estimated Useful Life (Details)
Ticker: ALVR
CIK: 1754068
Form Type: 10-K Annual Report
Accession Number: 0000950170-22-001075
Submitted to the SEC: Thu Feb 10 2022 4:06:48 PM EST
Accepted by the SEC: Thu Feb 10 2022
Period: Friday, December 31, 2021
Industry: Biological Products No Disgnostic Substances

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