Full Press Release Details
AlloVir Reports Second Quarter 2022 Financial Results
Three Phase 3 Posoleucel Registrational Trials Continue to Expand Globally, Enrolling Patients in the U.S., Europe and Asia
Company Is On Track to Release Final Results of Posoleucel Phase 2 Multi-Virus Prevention Study at
Year-End and Topline Results of Phase 2 BKV Treatment Study in Kidney Transplant Patients in 1Q 23
$126.6 Million Registered Direct Offering in July 2022 Will Support the Completion of Three Phase 3 Registrational Trials of Posoleucel and
Global Regulatory Submissions
Waltham, Mass., August 4, 2022 AlloVir, Inc. (Nasdaq: ALVR), a multiple Phase 3
clinical trial stage allogeneic T cell immunotherapy company, today reported financial results for the second quarter ended June 30, 2022. The Company also shared progress across its pipeline of multi-virus specific T cell (VST) therapies,
including continued positive, preliminary Phase 2 data on posoleucel and the securing of additional capital to enable the completion of the three ongoing Phase 3 registrational trials of posoleucel and global regulatory submissions for three
distinct indications the treatment of virus-associated hemorrhagic cystitis (vHC), the treatment of adenovirus (AdV) infection, and the prevention of clinically significant infections from AdV, BK virus (BKV), cytomegalovirus (CMV),
Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV), all in allogeneic hematopoietic cell transplant (allo-HCT) recipients.
In the first half of 2022, AlloVir made great progress advancing our pipeline of
off-the-shelf, multi-virus specific T cell therapies, especially with our lead candidate, posoleucel. The preliminary Phase 2 multi-virus prevention data have
strengthened awareness of the transformational potential of posoleucel as preemptive or prophylactic therapy for viral infections post allo-HCT and have facilitated engagement in our Phase 3 program with leading international transplant
centers, said Diana Brainard, M.D., Chief Executive Officer, AlloVir. In addition, we are excited to have the strong support of our investors who recently provided additional capital to enable the completion, data readouts and global
regulatory submissions for all three ongoing Phase 3 registrational trials of posoleucel. We believe their investment demonstrates a strong affirmation of our science and ability to execute our plans to deliver this potentially transformative
therapy to immunocompromised patients in need.
The multi-virus prevention study evaluates the use of posoleucel either as prophylactic therapy in patients without
viremia or preemptive therapy for patients who have reactivated one or more of the target viruses. Multi-virus prevention has the potential to transform the management of transplant patients, who currently have limited to no approved treatment
options for these devastating infections that threaten patient survival.
This adds to the Regenerative Medicine Advanced Therapy (RMAT)
designation for multi-virus prevention that the U.S. Food and Drug Administration granted to posoleucel in April 2022, and prior RMAT designations for the treatment of AdV infection and for the treatment of hemorrhagic cystitis caused by BK viremia
in adults and children, all following allo-HCT. To the Company s knowledge, posoleucel is the only cell or gene therapy with three RMAT designations.
Upcoming Highlights/Activities
Second 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 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 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.
CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 172,673 | $ | 248,120 | ||||
| Other current assets | 3,844 | 5,228 | ||||||
| Total current assets | 176,517 | 253,348 | ||||||
| Other assets | 23,478 | 33,246 | ||||||
| Total assets | $ | 199,995 | $ | 286,594 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 21,588 | $ | 37,853 | ||||
| Long-term liabilities | 20,270 | 23,475 | ||||||
| Total liabilities | 41,858 | 61,328 | ||||||
| Total stockholders equity | 158,137 | 225,266 | ||||||
| Total liabilities and stockholders equity | $ | 1,99,995 | $ | 286,594 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 31,379 | 25,677 | 60,446 | 46,070 | ||||||||||||
| General and administrative | 13,245 | 11,978 | 27,371 | 22,448 | ||||||||||||
| Total operating expenses | 44,624 | 37,655 | 87,817 | 68,518 | ||||||||||||
| Loss from operations | (44,624 | ) | (37,655 | ) | (87,817 | ) | (68,518 | ) | ||||||||
| Total other income (loss), net: | ||||||||||||||||
| Interest income | 162 | 475 | 310 | 980 | ||||||||||||
| Other (loss) income, net | (27 | ) | (408 | ) | (845 | ) | (973 | ) | ||||||||
| Loss before income taxes | (44,489 | ) | (37,588 | ) | (88,352 | ) | (68,511 | ) | ||||||||
| Income tax expense | 150 | 150 | ||||||||||||||
| Net loss | $ | (44,639 | ) | $ | (37,588 | ) | $ | (88,502 | ) | $ | (68,511 | ) | ||||
| Net loss per share basic and diluted | $ | (0.69 | ) | $ | (0.60 | ) | $ | (1.38 | ) | $ | (1.10 | ) | ||||
| Weighted-average common shares outstanding basic and | 64,467,483 | 62,344,718 | 64,231,579 | 62,399,034 |
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