Full Press Release Details
AlloVir Reports First Quarter 2022 Financial Results
Initiated posoleucel registrational study to prevent six devastating viral infections and now enrolling high-risk allo-HCT patients in the U.S., Western Europe and Asia
FDA granted RMAT designation to posoleucel
for Phase 3 multi-virus prevention indication with an estimated annual addressable patient population of 40,000 allo-HCT patients
Progressed enrollment in three Phase 3 studies for posoleucel and a Phase 2 trial for ALVR106
Completed enrollment in Phase 2 study of posoleucel for the treatment of BK viremia in kidney transplant patients; initial blinded data will
be presented at the American Transplant Congress in June
Waltham, Mass., May 5, 2022 AlloVir, Inc. (Nasdaq: ALVR), a
multiple Phase 3 clinical trial stage allogeneic T cell immunotherapy company, today reported financial results for the first quarter ended March 31, 2022. The company also shared progress across its virus-specific T cell (VST) programs, with
its lead product, posoleucel, advancing into Phase 3 development for the prevention of infections and disease from six devastating viruses that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT) adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and
JC virus (JCV). Multi-virus prevention has the potential to transform the management of transplant patients, who currently have limited to no approved treatment options for these infections that threaten patient survival. The U.S. Food and Drug
Administration (FDA) granted posoleucel Regenerative Medicine Advanced Therapy (RMAT) designation for this multi-virus prevention approach in high-risk adult and pediatric allo-HCT patients.
We are focused on rapidly advancing our lead product candidate, posoleucel, with the aim of delivering this potentially transformative therapy to
patients in need as quickly as possible. Based on the strength of our Phase 2 data in both treatment and prevention, we now have three Phase 3 studies underway that aim to address a spectrum of needs in the
post-allo-HCT setting as a treatment for patients already suffering the devastating impact of viral infections and disease, as a preemptive therapy for patients who have reactivated one or more viruses,
and as a prophylactic therapy in high-risk patients without viremia, said Diana Brainard, M.D., Chief Executive Officer, AlloVir. The multi-virus prevention approach is the most transformative use of posoleucel and, accordingly, we are
seeing strong enthusiasm from hematologists and infectious disease specialists as we expand our Phase 3 study sites and enrollment.
Upcoming Q2 2022 Highlights/Activities
First Quarter 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
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, including but not limited to the risks discussed in
AlloVir s Annual Report on Form 10-K for the year ended December 31, 2021 and in our other filings with the SEC. 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)
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 201,375 | $ | 248,120 | ||||
| Other current assets | 5,066 | 5,228 | ||||||
| Total current assets | 206,441 | 253,348 | ||||||
| Other assets | 24,649 | 33,246 | ||||||
| Total assets | $ | 231,090 | $ | 286,594 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 18,639 | $ | 37,853 | ||||
| Long-term liabilities | 20,776 | 23,475 | ||||||
| Total liabilities | 39,415 | 61,328 | ||||||
| Total stockholders equity | 191,675 | 225,266 | ||||||
| Total liabilities and stockholders equity | $ | 231,090 | $ | 286,594 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 29,067 | $ | 20,393 | ||||
| General and administrative | 14,126 | 10,470 | ||||||
| Total operating expenses | 43,193 | 30,863 | ||||||
| Loss from operations | (43,193 | ) | (30,863 | ) | ||||
| Total other income (loss), net: | ||||||||
| Interest income | 148 | 505 | ||||||
| Other (loss) income, net | (818 | ) | (565 | ) | ||||
| Loss before income taxes | (43,863 | ) | (30,923 | ) | ||||
| Income tax expense | ||||||||
| Net loss | $ | (43,863 | ) | $ | (30,923 | ) | ||
| Net loss per share basic and diluted | $ | (0.69 | ) | $ | (0.50 | ) | ||
| Weighted-average common shares outstanding basic and diluted | 63,993,053 | 62,193,734 |
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