AlloVir Reports Third Quarter 2023 Financial Results
-- Posoleucel, a highly innovative off-the-shelf, multi-virus-specific investigational T cell therapy, continues to advance in three distinct, Phase 3, first-to-market indications in immunocompromised patients
-- Enrollment in posoleucel pivotal Phase 3 multi-virus prevention, virus-associated hemorrhagic cystitis and adenovirus studies all progressing with topline data for all three studies anticipated in the second half of 2024
--Progressing global commercial launch planning for posoleucel across all indications
-- As of
“At AlloVir, we are dedicated to serving immunocompromised patients suffering from devastating and life-threatening viral diseases,” said
Recent and Upcoming Highlights/Activities
- The company’s Phase 3 registrational trials of posoleucel in allo-HCT patients continue to enroll with data anticipated from all three trials in the second half of 2024.
-
The company presented results from a Phase 2 randomized, placebo-controlled trial evaluating posoleucel for the treatment of BKV in adult kidney transplant recipients at the
European Society for Organ Transplantation (ESOT) Congress 2023 in September. - The company continues to work with regulatory agencies to gain alignment on a Phase 3 clinical study design to evaluate posoleucel’s treatment of BKV infection in kidney transplant patients.
- The company completed enrollment in Part A of the Phase 1b/2a clinical trial of ALVR106, a multi-respiratory virus-specific T cell therapy targeting human metapneumovirus, influenza, parainfluenza, and respiratory syncytial virus (RSV) in allo-HCT and solid organ transplant patients. Data will be shared at a future scientific congress.
Third Quarter Financial Results
-
Research and development expenses were
$34.2 million for the quarter endedSeptember 30, 2023 , compared with$30.0 million for the quarter endedSeptember 30, 2022 . The increase year-over-year was primarily attributable to an increase in costs related to the development of the company’s lead product candidate, posoleucel. -
General and administrative expenses were consistent at
$12.8 million for the quarter endedSeptember 30, 2023 , compared with$12.9 million for the quarter endedSeptember 30, 2022 . -
Stock-based compensation expenses were
$10.5 million and$10.9 million for the quarter endedSeptember 30, 2023 , and 2022, respectively. -
As of
September 30, 2023 ,AlloVir had cash, cash equivalents, and short-term investments of$213.3 million , compared with cash, cash equivalents, and short-term investments of$233.8 million as ofDecember 31, 2022 . -
For the quarter ended
September 30, 2023 , net loss was$44.3 million or$0.39 per share compared with a net loss of$42.1 million or$0.50 per share for the quarter endedSeptember 30, 2022 .
2023 Financial Guidance
-
For fiscal year 2023,
AlloVir expects operating expenses to be in the range of$150 million to$170 million , excluding non-cash expenses.
About Posoleucel
About
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 potential of posoleucel as a treatment for three distinct indications in allo-HCT patients, the potential of posoleucel to prevent infection or disease, the potential of posoleucel to treat vHC or AdV, the timing of data readouts for our three Phase 3 studies and regulatory milestones, the projection that our cash will fund operations through data readouts for our three Phase 3 pivotal trials, that the next 12 months will be catalyst rich with clinical and regulatory milestones, that preventing viral infections in allo-HCT patients could be transformational, our anticipated commercial launch in 2025,
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(unaudited, in thousands) | ||||||
2023 |
2022 |
|||||
Assets | ||||||
Current assets: | ||||||
Cash, cash equivalents and short-term investments | $ |
213,318 |
$ |
233,795 |
||
Other current assets |
6,701 |
9,257 |
||||
Total current assets |
220,019 |
243,052 |
||||
Other assets |
28,293 |
34,027 |
||||
Total assets | $ |
248,312 |
$ |
277,079 |
||
Liabilities and stockholders’ equity | ||||||
Current liabilities | $ |
33,066 |
$ |
24,338 |
||
Long-term liabilities |
19,912 |
28,222 |
||||
Total liabilities |
52,978 |
52,560 |
||||
Total stockholders’ equity |
195,334 |
224,519 |
||||
Total liabilities and stockholders’ equity | $ |
248,312 |
$ |
277,079 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(unaudited, in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|
||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ |
34,156 |
|
$ |
30,004 |
|
$ |
99,698 |
|
$ |
90,450 |
|
||||
General and administrative |
12,805 |
|
12,946 |
|
37,797 |
|
40,318 |
|
||||||||
Total operating expenses |
46,961 |
|
42,950 |
|
137,495 |
|
130,768 |
|
||||||||
Loss from operations |
(46,961 |
) |
(42,950 |
) |
(137,495 |
) |
(130,768 |
) |
||||||||
Total other income (loss), net: | ||||||||||||||||
Interest income |
1,522 |
|
668 |
|
4,362 |
|
978 |
|
||||||||
Other income (loss), net |
1,167 |
|
210 |
|
2,411 |
|
(634 |
) |
||||||||
Loss before income taxes |
(44,272 |
) |
(42,072 |
) |
(130,722 |
) |
(130,424 |
) |
||||||||
Income tax expense |
- |
|
- |
|
- |
|
150 |
|
||||||||
Net loss | $ |
(44,272 |
) |
$ |
(42,072 |
) |
$ |
(130,722 |
) |
$ |
(130,574 |
) |
||||
Net loss per share --- basic and diluted | $ |
(0.39 |
) |
$ |
(0.50 |
) |
$ |
(1.30 |
) |
$ |
(1.83 |
) |
||||
Weighted-average common shares outstanding --- basic and diluted |
113,894,188 |
|
84,948,837 |
|
100,683,322 |
|
71,213,219 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231102786767/en/
Media and Investor:
ir@allovir.com
Source: