AlloVir Reports Third Quarter 2023 Financial Results
- AlloVir continues to progress its highly innovative lead therapeutic candidate, posoleucel, by enrolling globally in three Phase 3 trials for first-to-market indications.
- The company presented positive results from a Phase 2 trial of posoleucel for the treatment of BKV in adult kidney transplant recipients.
- Enrollment in the Phase 1b/2a trial of ALVR106, a multi-respiratory virus-specific T cell therapy, targeting human metapneumovirus, influenza, parainfluenza, and respiratory syncytial virus, has been completed.
- As of September 30, 2023, AlloVir had cash, cash equivalents, and short-term investments of $213.3 million.
- None.
-- 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 September 30, 2023, AlloVir had cash, cash equivalents, and short-term investments of
“At AlloVir, we are dedicated to serving immunocompromised patients suffering from devastating and life-threatening viral diseases,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “We are working with urgency to complete enrollment in our three global Phase 3 pivotal trials of posoleucel to deliver this potentially transformative therapy to patients that can benefit from the prevention and treatment of viral diseases with limited to no approved or effective therapies today. We expect a catalyst rich next 12 months with clinical and regulatory milestones and continued commercial preparations in advance of a potential 2025 launch.”
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 $30.0 million -
General and administrative expenses were consistent at
$12.8 million $12.9 million -
Stock-based compensation expenses were
$10.5 million $10.9 million -
As of September 30, 2023, AlloVir had cash, cash equivalents, and short-term investments of
$213.3 million $233.8 million -
For the quarter ended September 30, 2023, net loss was
$44.3 million $0.39 $42.1 million $0.50
2023 Financial Guidance
-
For fiscal year 2023, AlloVir expects operating expenses to be in the range of
$150 million $170 million
About Posoleucel
AlloVir's lead product, posoleucel, is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus-specific T cell therapy targeting six viral pathogens in immunocompromised individuals: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV). In a Phase 2 open-label study of posoleucel for the prevention of clinically significant infections due to the six viruses posoleucel targets,
About AlloVir
AlloVir is a leading late-clinical stage cell therapy company focused 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 platform leverages 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 www.allovir.com or follow us on X or LinkedIn.
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, AlloVir's development and regulatory status of its 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 the safety and efficacy of posoleucel, 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
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (unaudited, in thousands) | ||||||
| September 30, | December 31, | |||||
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 |
||
| ALLOVIR, INC. | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (unaudited, in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
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: AlloVir, Inc.
FAQ
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