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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

Key Takeaway: 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 po

Full Press Release Details

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
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.
Advancing Posoleucel Development
Expanding into Respiratory Viruses
Three Phase 3 Studies of Posoleucel in
Three Distinct Indications with No Approved Therapies
New Data Adding to the Understanding of the Potential for Posoleucel
Advancing Two Additional VST Therapies
2021 Financial Highlights
2022 Financial Guidance
AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric
and adult patients with weakened immune systems. The company s innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single- and
multi-virus-specific T cells for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir s technology and manufacturing process enable the potential for the treatment and prevention of
a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information,
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including,
without limitation, statements regarding AlloVir s development and regulatory status of our product candidates, the planned conduct of its preclinical studies, and clinical trials and its prospects for success in those studies and trials, and
its strategy, business plans and focus. The words may, will, could, would, should, expect, plan, anticipate, intend, believe,
estimate, predict, project, potential, continue, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements
contain these identifying words. Any forward-looking statements in this press release are based on management s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual
events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir s financial results, the timing for the initiation
and successful completion of AlloVir s clinical trials of its product candidates, whether and when, if at all, AlloVir s product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign
regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir s product development plans, supply chain, and business operations and other
risks identified in AlloVir s SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking
statements. Any forward-looking statements contained in this press release represent AlloVir s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
December 31,
2021 2020
Assets
Current assets:
Cash, cash equivalents and short- term investments $ 248,120 $ 356,324
Other current assets 5,228 4,993
Total current assets 253,348 361,317
Other assets 33,246 9,504
Total assets $ 286,594 $ 370,821
Liabilities and stockholders equity
Current liabilities $ 37,853 $ 12,294
Long-term liabilities 23,475 5,463
Total liabilities 61,328 17,757
Total stockholders equity 225,266 353,064
Total liabilities and stockholders equity $ 286,594 $ 370,821
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
Years Ended December 31,
2021 2020
Operating expenses:
Research and development 120,735 49,663
General and administrative 49,083 21,646
Total operating expenses 169,818 71,309
Loss from operations (169,818 ) (71,309 )
Total other income (loss), net:
Interest income 1,315 1,330
Other (loss) income, net (2,452 ) 195
Loss before income taxes (170,955 ) (69,784 )
Income tax expense 1,007
Net loss $ (171,962 ) $ (69,784 )
Net loss per share basic and diluted $ (2.74 ) $ (2.59 )
Weighted-average common shares outstanding basic and diluted 62,782,126 26,897,390
Last updated: Feb 10, 2022