Full Press Release Details
AlloVir Reports First Quarter 2021 Financial Results
- Viralym-M pivotal trial in virus-associated hemorrhagic cystitis continues to progress
- Viralym-M proof-of-concept studies in multi-virus prevention in stem cell transplant and
BK viremia in kidney transplant continue to progress with initial data expected 4Q21
- Additional Viralym-M pivotal and proof-of-concept clinical
trials expected to initiate in
- ALVR109 proof-of-concept study in high-risk COVID-19 patients progressing, initial data
- ALVR106 IND cleared with proof-of-concept study in RSV,
metapneumovirus, and parainfluenza expected to initiate in 2H21
- Dr. Diana Brainard s transition from independent director to CEO has commenced with
an official start date of May 17; David Hallal to continue to serve as Executive Chairman of the Board
CAMBRIDGE, Mass. (BUSINESS WIRE) May 6, 2021 AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company,
today reported financial results for the first quarter ended March 31, 2021.
The first quarter of 2021 was one of significant progress for
AlloVir and moved us closer towards our ambition to transform the lives of patients suffering from devastating and life-threatening viral diseases, said David Hallal, Chief Executive Officer and Chairman of the Board, AlloVir. The
appointment of Dr. Diana Brainard as our new CEO brings an unparalleled track record of success in building strong, durable global virology franchises, that have impacted the world, and I look forward to working with Diana and the team in my
new role as Executive Chairman of the Board.
Dr. Diana Brainard, AlloVir s newly named Chief Executive Officer, continued by saying,
With a world-renowned team of scientists, clinical and regulatory experts, and company operators, AlloVir has quickly advanced to become a leader in the development of innovative cell therapies. The remainder of 2021 will be an exciting time
of growth for the company, which is on track to have initial data readouts from three clinical trials and initiate up to four more this year. Together with the Board, the executive team and all of AlloVir s high-performing employees, I look
forward to advancing our impressive pipeline of mid- and late-stage clinical trials with a commitment to bringing innovative therapies to patients in need around the globe.
Business Updates and Upcoming Milestones
First Quarter Business and Scientific Updates
Viralym-M for HSCT Recipients
Viralym-M for Solid Organ Transplant (SOT) Recipients
ALVR109 for COVID-19
ALVR106 for Multi-Respiratory Viruses
First 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)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 336,992 | $ | 356,324 | ||||
| Other current assets | 2,672 | 4,993 | ||||||
| Total current assets | 339,664 | 361,317 | ||||||
| Other assets | 11,617 | 9,504 | ||||||
| Total assets | $ | 351,281 | $ | 370,821 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | $ | 15,500 | $ | 12,294 | ||||
| Long-term liabilities | 5,412 | 5,463 | ||||||
| Total liabilities | 20,912 | 17,757 | ||||||
| Total stockholders equity | 330,369 | 353,064 | ||||||
| Total liabilities and stockholders equity | $ | 351,281 | $ | 370,821 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | 20,393 | 6,839 | ||||||
| General and administrative | 10,470 | 3,001 | ||||||
| Total operating expenses | 30,863 | 9,840 | ||||||
| Loss from operations | (30,863 | ) | (9,840 | ) | ||||
| Total other income (loss), net: | ||||||||
| Interest income | 505 | 457 | ||||||
| Other income (loss), net | (565 | ) | 44 | |||||
| Net loss | $ | (30,923 | ) | $ | (9,339 | ) | ||
| Net loss per share - basic and diluted | $ | (0.50 | ) | $ | (4.21 | ) | ||
| Weighted-average common shares outstanding - basic and diluted | 62,193,734 | 2,215,958 |