Full Press Release Details
AlloVir Reports Third Quarter 2020 Financial Results
Completed initial public offering raising $317.7M in gross proceeds
Viralym-M (multi-virus-specific T cell therapy) registrational study in lead indication in virus-associated
hemorrhagic cystitis and proof-of-concept study in prevention of multiple viral infections on track to initiate before year end
ALVR109 (virus-specific T cell therapy designed to combat SARS-CoV-2) Phase 1/2 clinical trial initiated for the treatment of high risk COVID-19 patients
Commenced tech transfer for AlloVir proprietary virus-specific T-cell
manufacturing process to ElevateBio BaseCamp, as part of planned manufacturing capacity expansion and redundancy within supply chain
Mass. November 10, 2020 AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, today reported financial results for the third quarter ended September 30, 2020.
In the third quarter, we completed our $317.7 million initial public offering creating a solid financial foundation for the next stage of
AlloVir s growth, said David Hallal, Chairman and Chief Executive Officer of AlloVir. We are now focused on leveraging our robust capabilities to execute our objectives across our pipeline, including commencing up to nine pivotal
and proof-of-concept studies across three cell therapies this year and throughout 2021.
David Hallal continued, the Phase 1/2 clinical trial with ALVR109, our virus-specific T cell therapy designed to combat
SARS-CoV-2 the virus that causes COVID-19 has been initiated in high-risk patients and we are on track to initiate
two additional studies with our lead product, Viralym-M, including a registrational, Phase 3 clinical trial for the treatment of virus-associated hemorrhagic cystitis and a
proof-of-concept study for the prevention of multiple viral infections, both in allogeneic stem cell transplant patients before year end.
Third Quarter Business Highlights
Viralym-M (ALVR105) Program Highlights
ALVR109 Program Highlights
ALVR106 Program Highlights
Third Quarter 2020 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 patients with weakened immune systems. The company s innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, 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 enables 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 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 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, 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| (in thousands, except share and per share data) | Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue | $ | $ | $ | $ | 165 | |||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 17,182 | 5,655 | 32,906 | 9,561 | ||||||||||||
| General and administrative | 6,718 | 2,823 | 12,987 | 7,800 | ||||||||||||
| Total operating expenses | 23,900 | 8,478 | 45,893 | 17,361 | ||||||||||||
| Loss from operations | (23,900 | ) | (8,478 | ) | (45,893 | ) | (17,196 | ) | ||||||||
| Total other income, net: | ||||||||||||||||
| Interest income | 112 | 781 | 735 | 1,400 | ||||||||||||
| Other income, net | 174 | 427 | 573 | 700 | ||||||||||||
| Net loss | $ | (23,614 | ) | $ | (7,270 | ) | $ | (44,585 | ) | $ | (15,096 | ) | ||||
| Net loss per share basic and diluted | $ | (0.58 | ) | $ | (4.97 | ) | $ | (2.93 | ) | $ | (13.67 | ) | ||||
| Weighted-average common shares outstanding basic and diluted | 40,465,705 | 1,463,421 | 15,195,000 | 1,104,454 |
CONDENSED CONSOLIDATED BALANCE SHEETS
| (in thousands) | September 30, | December 31, | ||||||
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 378,488 | $ | 126,077 | ||||
| Other current assets | 5,453 | 1,236 | ||||||
| Total current assets | 383,941 | 127,313 | ||||||
| Other assets | 9,769 | 12,109 | ||||||
| Total assets | $ | 393,710 | $ | 139,422 | ||||
| Liabilities and stockholders deficit | ||||||||
| Current liabilities | $ | 13,521 | $ | 9,106 | ||||
| Long-term liabilities | 6,286 | 8,692 | ||||||
| Total liabilities | 19,807 | 17,798 | ||||||
| Preferred stock | 173,127 | |||||||
| Total stockholders equity (deficit) | 373,903 | (51,503 | ) | |||||
| Total liabilities, preferred stock, and stockholders deficit | $ | 393,710 | $ | 139,422 |