Full Press Release Details
AlloVir Reports Third Quarter 2021 Financial Results
Company is prioritizing prevention and treatment programs with the potential to transform transplant patient care and outcomes
Positive interim data from posoleucel multi-virus prevention Phase 2 study will be presented at ASH
Posoleucel Phase 3 study for the treatment of adenovirus and ALVR106
proof-of-concept clinical trial for the treatment of multiple respiratory viruses are on track to initiate this year
Cambridge, Mass., November 5, 2021 AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, today reported
financial results for the third quarter ended September 30, 2021. The company also shared progress on the advancement of its prioritized virus-specific T cell (VST) programs to prevent or treat life-threatening viral diseases.
AlloVir s allogeneic, off-the-shelf, virus-specific T cell platform
has the potential to transform the care of and outcomes for patients from stem cell and solid organ transplant recipients to broader patient groups with immunodeficiency. The interim data we will be presenting at ASH provide the first look at
the potential for posoleucel, a multi-virus specific T cell therapy, to change the treatment paradigm for stem cell transplant recipients, moving upstream to prevent the most common life-threatening viral diseases for these patients before they
occur, said Diana Brainard, M.D., Chief Executive Officer, AlloVir. Across our portfolio, we are prioritizing programs with the largest potential benefit for patients, including the prevention of life-threatening viral diseases caused by
six devastating viruses with a single therapy. We are focusing on key areas where there are limited or no treatment options, such as hemorrhagic cystitis, BK viremia and adenovirus.
Upcoming Q4 2021 Highlights/Activities:
Recent Clinical and Scientific Highlights:
Third Quarter Financial Highlights:
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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 275,841 | $ | 356,324 | ||||
| Other current assets | 6,031 | 4,993 | ||||||
| Total current assets | 281,872 | 361,317 | ||||||
| Other assets | 34,658 | 9,504 | ||||||
| Total assets | $ | 316,530 | $ | 370,821 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 24,173 | $ | 12,294 | ||||
| Long-term liabilities | 25,053 | 5,463 | ||||||
| Total liabilities | 49,226 | 17,757 | ||||||
| Total stockholders equity | 267,304 | 353,064 | ||||||
| Total liabilities and stockholders equity | $ | 316,530 | $ | 370,821 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 33,062 | 17,182 | 79,132 | 32,906 | ||||||||||||
| General and administrative | 12,442 | 6,718 | 34,890 | 12,987 | ||||||||||||
| Total operating expenses | 45,504 | 23,900 | 114,022 | 45,893 | ||||||||||||
| Loss from operations | (45,504 | ) | (23,900 | ) | (114,022 | ) | (45,893 | ) | ||||||||
| Total other income (loss), net: | ||||||||||||||||
| Interest income | 253 | 112 | 1,233 | 735 | ||||||||||||
| Other (loss) income, net | (259 | ) | 174 | (1,232 | ) | 573 | ||||||||||
| Net loss | $ | (45,510 | ) | $ | (23,614 | ) | $ | (114,021 | ) | $ | (44,585 | ) | ||||
| Net loss per share basic and diluted | $ | (0.72 | ) | $ | (0.58 | ) | $ | (1.82 | ) | $ | (2.93 | ) | ||||
| Weighted-average common shares outstanding basic and diluted | 62,962,434 | 40,465,705 | 62,588,898 | 15,195,000 |