Full Press Release Details
AlloVir Reports First Quarter 2023 Financial Results
Company s three posoleucel Phase 3 global registrational trials for three distinct, first-to-market
indications continue to enroll with data readouts on track for 2024
Positive results from a randomized, double-blind, placebo-controlled Phase 2 study of posoleucel in
kidney transplant recipients with BK viremia will be presented at the American Transplant Congress 2023 later this quarter
WALTHAM, MA May 4, 2023 AlloVir (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today
reported financial results from the first quarter ended March 31, 2023. The company shared progress across its allogeneic, off-the-shelf-virus specific T cell (VST)
programs, including its lead investigational therapy, posoleucel, for prevention and treatment of life-threatening infections and diseases from up to six viruses that commonly impact patients following allogeneic hematopoietic cell transplant
(allo-HCT), and for the treatment of BK viremia (BKV) in adult kidney transplant recipients.
We continue to focus our efforts on rapidly advancing
the three global Phase 3 ongoing registrational trials evaluating our lead investigational product, posoleucel, for the prevention and treatment of common, yet devastating, and potentially life-threatening viral infections and diseases in allo-HCT
patients where significant unmet need persists, said Diana Brainard, MD, Chief Executive Officer, AlloVir. In tandem, we reported final positive results from the Phase 2 study of posoleucel for the treatment of BKV, the first
demonstration of its safety and antiviral effect in solid organ transplant recipients. We continue to be encouraged by the potential of posoleucel as a transformative therapeutic for transplant patients.
Upcoming Highlights/Activities
First Quarter Financial Highlights
2023 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
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 the future enrollment status and timing for data readouts for AlloVir s three Phase 3 clinical trials, the potential safety and efficacy of AlloVir s product candidates, the development and
regulatory status of AlloVir s 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 (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 annual report on Form 10-K for year ended December 31, 2023 and in its other 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | 30,718 | 29,067 | ||||||
| General and administrative | 12,513 | 14,126 | ||||||
| Total operating expenses | 43,231 | 43,193 | ||||||
| Loss from operations | (43,231 | ) | (43,193 | ) | ||||
| Total other income (loss), net: | ||||||||
| Interest income | 1,325 | 148 | ||||||
| Other income (loss), net | 723 | (818 | ) | |||||
| Net loss | $ | (41,183 | ) | $ | (43,863 | ) | ||
| Net loss per share basic and diluted | $ | (0.44 | ) | $ | (0.69 | ) | ||
| Weighted-average common shares outstanding basic and diluted | 93,303,672 | 63,993,053 |
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 202,570 | $ | 233,795 | ||||
| Other current assets | 9,705 | 9,257 | ||||||
| Total current assets | 212,275 | 243,052 | ||||||
| Other assets | 31,769 | 34,027 | ||||||
| Total assets | $ | 244,044 | $ | 277,079 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 24,959 | $ | 24,338 | ||||
| Long-term liabilities | 25,553 | 28,222 | ||||||
| Total liabilities | 50,512 | 52,560 | ||||||
| Total stockholders equity | 193,532 | 224,519 | ||||||
| Total liabilities and stockholders equity | $ | 244,044 | $ | 277,079 |
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