Full Press Release Details
AlloVir Reports Second Quarter 2021 Financial Results
- Posoleucel (Viralym-M, ALVR105)
proof-of-concept studies in multi-virus prevention in stem cell transplant patients and BK viremia in kidney transplant patients continue to progress with initial data
- Posoleucel Phase 3 pivotal trial in virus-associated hemorrhagic cystitis continues to
proof-of-concept study in respiratory syncytial virus, influenza, human metapneumovirus, and parainfluenza expected to initiate in 2H21
Cambridge, MA, August 6, 2021 AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, today reported financial
results for the second quarter ended June 30, 2021.
We believe virus-specific T-cell therapies can
have a meaningful impact in treating as well as preventing multiple devastating viral infections. This approach is groundbreaking in the field of stem cell transplantation and has the potential to transform care for patients and health care
providers, said Dr. Diana Brainard, Chief Executive Officer of AlloVir. We are pleased with the progress of our
first-of-its-kind posoleucel (Viralym-M, ALVR105) multi-virus prevention clinical trial in allogeneic hematopoietic stem cell
transplant recipients and look forward to sharing initial results from that study later this year. In addition, enrollment continues to progress in our posoleucel BK viremia in kidney transplant proof-of-concept study, as well as our registrational study in virus-associated hemorrhagic cystitis.
Business Updates and Upcoming Milestones
Quarter Business and Scientific Milestones
2021 Near-Term Priorities Across Programs
Second Quarter 2021 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 targeting devastating viruses 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 visit www.allovir.com.
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)
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 313,337 | $ | 356,324 | ||||
| Other current assets | 2,708 | 4,993 | ||||||
| Total current assets | 316,045 | 361,317 | ||||||
| Other assets | 11,466 | 9,504 | ||||||
| Total assets | $ | 327,511 | $ | 370,821 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 20,708 | $ | 12,294 | ||||
| Long-term liabilities | 4,334 | 5,463 | ||||||
| Total liabilities | 25,042 | 17,757 | ||||||
| Total stockholders equity | 302,469 | 353,064 | ||||||
| Total liabilities and stockholders equity | $ | 327,511 | $ | 370,821 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | 25,677 | 8,885 | ||||||
| General and administrative | 11,978 | 3,268 | ||||||
| Total operating expenses | 37,655 | 12,153 | ||||||
| Loss from operations | (37,655 | ) | (12,153 | ) | ||||
| Total other income (loss), net: | ||||||||
| Interest income | 475 | 166 | ||||||
| Other income (loss), net | (408 | ) | 355 | |||||
| Net loss | $ | (37,588 | ) | $ | (11,632 | ) | ||
| Net loss per share basic and diluted | $ | (0.60 | ) | $ | (4.43 | ) | ||
| Weighted-average common shares outstanding basic and diluted | 62,344,718 | 2,625,648 |