Full Press Release Details
AlloVir Reports Full-Year 2022 Financial Results and 2023 Outlook
Completion of enrollment of all three posoleucel Phase 3 registrational trials for three distinct, first-to-market indications anticipated by end of 2023 and data readouts in 2024
final results from randomized, double-blind, placebo-controlled Phase 2 study of posoleucel in kidney transplant recipients with BK viremia announced separately today; company to host investor webcast at 9:00 a.m. EST
Strong cash position, with $233.8 million as of year-end 2022
WALTHAM, Mass. (BUSINESS WIRE) Feb. 15, 2023 AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company,
today reported full-year 2022 financial results for the period ended December 31, 2022. The company also highlighted its progress and provided the outlook for 2023 and into 2024 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 caused by six viruses
that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT).
With the acceleration of the posoleucel multi-virus
prevention study and continued enrollment in the viral hemorrhagic cystitis and adenovirus treatment Phase 3 studies in 2022, the posoleucel franchise is positioned for potentially significant value creation over the next 12-24 months, said Diana Brainard, M.D., Chief Executive Officer, AlloVir. During 2023, we plan to complete enrollment in our Phase 3 registrational studies, which would enable data readouts in 2024 and,
with positive results, regulatory filings and acceleration of commercial preparations to follow.
Dr. Brainard continued, Today we also
announced positive final Phase 2 results from our first study of posoleucel in the solid organ transplant setting, showing balanced safety across the posoleucel and placebo groups and clinically meaningful greater viral load declines with posoleucel
versus placebo in kidney transplant patients with BKV. These results are important proof of concept for the use of posoleucel in the solid organ transplant setting. We look forward to working with regulatory authorities and transplant specialists on
our future clinical development plans for this patient population with high unmet medical need.
Outlook 2023 and Into 2024
Posoleucel: AlloVir s lead investigational therapy, posoleucel, offers a franchise opportunity, with three indications being evaluated in Phase 3
registrational trials.
Earlier Stage Pipeline: AlloVir s early clinical and preclinical VST therapy candidates provide portfolio expansion opportunities, with
pipeline advancement led by AlloVir or a potential partner.
2022 Financial Highlights
2023 Financial Guidance
Investor Webcast Details
The company will host an investor webcast today at 9:00 a.m. EST to discuss the BKV study findings and the potential clinical impact of using posoleucel to
treat viral infections in the solid organ transplant setting. The webcast will feature remarks from AlloVir CEO Diana Brainard, M.D., and from renal transplant specialist Anil K. Chandraker, M.D., Brigham and Women s Hospital.
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
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
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 the safety, efficacy and regulatory and clinical progress of our product
candidates, including posoleucel, the planned conduct of its preclinical studies, and clinical trials and its prospects for success in those studies and trials, the financial outlook for the full-year 2023, including estimates of operating expenses,
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 Securities and Exchange Commission (SEC) filings, including but not limited to the risks discussed in AlloVir s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2022 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)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 233,795 | $ | 248,120 | ||||
| Other current assets | 9,257 | 5,228 | ||||||
| Total current assets | 243,052 | 253,348 | ||||||
| Other assets | 34,027 | 33,246 | ||||||
| Total assets | $ | 277,079 | $ | 286,594 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 24,338 | $ | 37,853 | ||||
| Long-term liabilities | 28,222 | 23,475 | ||||||
| Total liabilities | 52,560 | 61,328 | ||||||
| Total stockholders equity | 224,519 | 225,266 | ||||||
| Total liabilities and stockholders equity | $ | 277,079 | $ | 286,594 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Years Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | l l8,870 | 120,735 | ||||||
| General and administrative | 52,332 | 49,083 | ||||||
| Total operating expenses | 171,202 | 169,818 | ||||||
| Loss from operations | (171,202 | ) | (169,818 | ) | ||||
| Total other income (loss), net: | ||||||||
| Interest income | 1,876 | 1,315 | ||||||
| Other income (loss), net | 35 1 | (2,452 | ) | |||||
| Loss before income taxes | (168,975 | ) | (170,955 | ) | ||||
| Income tax (benefit) expense | (265 | ) | 1,007 | |||||
| Net loss | $ | (168,710 | ) | $ | (171,962 | ) | ||
| Net loss per share basic and diluted | $ | (2.20 | ) | $ | (2.74 | ) | ||
| Weighted-average common shares outstanding basic and diluted | 76,654,856 | 62,782,126 |
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