Full Press Release Details
AlloVir Reports Third Quarter 2022 Financial Results
Posoleucel Continues to Advance in Three Ongoing Multi-National Phase 3 Registrational Trials
Final Data Presentation from Posoleucel Phase 2 Multi-Virus Prevention Study by Year-End
Company to Host Investor Webcast on December 14 with Clinical Trial Investigators on Posoleucel for Prevention of Viral Infections in
Patients Following Allogeneic Stem Cell Transplant
Final Topline Data from Posoleucel Phase 2 Study for Treatment of BK Viremia in
Kidney Transplant Patients on Track to be Released in Q1 2023
Waltham, Mass., November 3, 2022 AlloVir, Inc.
(Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results for the third quarter ended September 30, 2022, and shared progress across its allogeneic, off-the-shelf, virus-specific T cell (VST) programs, including its lead investigational therapy, posoleucel, for the treatment and prevention of life-threatening infections and diseases from up to six viruses
that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT).
We are focused on rapidly advancing the ongoing
posoleucel Phase 3 registrational trials, with the goal of delivering a significant clinical advance for allo-HCT patients who currently have very limited therapeutic and preventive options for these common, yet devastating and potentially
life-threatening, viral infections and diseases, said Diana Brainard, M.D., Chief Executive Officer, AlloVir. We are particularly excited to report final data before year-end from the Phase 2
multi-virus prevention study, where preliminary results supported the acceleration of our global Phase 3 study for this potential indication. Preventing clinically significant viral infections and diseases after allo-HCT represents the most
transformative use of posoleucel.
AlloVir plans to host an investor webcast on Wednesday, December 14 at 4:30 p.m. ET, to discuss the unmet medical need for and clinical value of a
multi-virus prevention approach in the management of allo-HCT patients. The webcast will feature remarks from CEO Diana Brainard; infectious disease specialist Sanjeet Singh Dadwal, M.D., City of Hope; and hematologist-oncologist and transplant
specialist Joseph McGuirk, D.O., University of Kansas Medical Center.
A live audio webcast of the presentation will be available on the
Investors & Press section of the AlloVir website at https://ir.allovir.com/events-and-presentations. An archived replay of the presentation will be
available on the website for 30 days following the event.
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: 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 allo-HCT patients, who currently have limited to no approved
treatment or prevention options for these devastating infections that threaten patient survival.
Posoleucel previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the
U.S. Food and Drug Administration for multi-virus prevention, the treatment of AdV infection and the treatment of virus-associated hemorrhagic cystitis 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
Third 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 information, visit
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
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 264,107 | $ | 248,120 | ||||
| Other current assets | 7,935 | 5,228 | ||||||
| Total current assets | 272,042 | 253,348 | ||||||
| Other assets | 21,656 | 33,246 | ||||||
| Total assets | $ | 293,698 | $ | 286,594 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 20,719 | $ | 37,853 | ||||
| Long-term liabilities | 19,753 | 23,475 | ||||||
| Total liabilities | 40,472 | 61,328 | ||||||
| Total stockholders equity | 253,226 | 225,266 | ||||||
| Total liabilities and stockholders equity | $ | 293,698 | $ | 286,594 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 30,004 | 33,062 | 90,450 | 79,132 | ||||||||||||
| General and administrative | 12,946 | 12,442 | 40,318 | 34,890 | ||||||||||||
| Total operating expenses | 42,950 | 45,504 | 130,768 | 114,022 | ||||||||||||
| Loss from operations | (42,950 | ) | (45,504 | ) | (130,768 | ) | (114,022 | ) | ||||||||
| Total other income (loss), net: | ||||||||||||||||
| Interest income | 668 | 253 | 978 | 1,233 | ||||||||||||
| Other income (loss), net | 210 | (259 | ) | (634 | ) | (1,232 | ) | |||||||||
| Loss before income taxes | (42,072 | ) | (45,510 | ) | (130,424 | ) | (114,021 | ) | ||||||||
| Income tax expense | 150 | |||||||||||||||
| Net loss | $ | (42,072 | ) | $ | (45,510 | ) | $ | (130,574 | ) | $ | (114,021 | ) | ||||
| Net loss per share basic and diluted | $ | (0.50 | ) | $ | (0.72 | ) | $ | (1.83 | ) | $ | (1.82 | ) | ||||
| Weighted-average common shares outstanding basic and diluted | 84,948,837 | 62,962,434 | 71,213,219 | 62,588,898 |
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