AlloVir Reports First Quarter 2023 Financial Results
04 Maio 2023 - 8:00AM
Business Wire
Company’s three posoleucel Phase 3 global
registrational trials for three distinct, first-to-market
indications continue to enroll with data readouts on track for
2024
Positive results from a randomized,
double-blind, placebo-controlled Phase 2 study of posoleucel in
kidney transplant recipients with BK viremia will be presented at
the American Transplant Congress 2023 later this quarter
AlloVir (Nasdaq: ALVR), a late-clinical stage allogeneic T cell
immunotherapy company, today reported financial results from the
first quarter ended March 31, 2023. The company shared progress
across its allogeneic, off-the-shelf-virus specific T cell (VST)
programs, including its lead investigational therapy, posoleucel,
for prevention and treatment of life-threatening infections and
diseases from up to six viruses that commonly impact patients
following allogeneic hematopoietic cell transplant (allo-HCT), and
for the treatment of BK viremia (BKV) in adult kidney transplant
recipients.
“We continue to focus our efforts on rapidly advancing the three
global Phase 3 ongoing registrational trials evaluating our lead
investigational product, posoleucel, for the prevention and
treatment of common, yet devastating, and potentially
life-threatening viral infections and diseases in allo-HCT patients
where significant unmet need persists,” said Diana Brainard, MD,
Chief Executive Officer, AlloVir. “In tandem, we reported final
positive results from the Phase 2 study of posoleucel for the
treatment of BKV, the first demonstration of its safety and
antiviral effect in solid organ transplant recipients. We continue
to be encouraged by the potential of posoleucel as a transformative
therapeutic for transplant patients.”
Recent Highlights
- In January 2023, the company announced plans to report data
from its three Phase 3 registrational studies for posoleucel in
2024 across three distinct indications – the prevention of
clinically significant infection or disease from adenovirus (AdV),
BK virus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human
herpesvirus-6 (HHV-6) and JC virus (JCV), the treatment of
virus-associated hemorrhagic cystitis (vHC), and the treatment of
AdV infection, all in allo-HCT patients. These viral infections
have limited to no approved preventive therapies or treatment
options, threatening patient survival.
- In February 2023, the company announced positive final results
from a Phase 2 study of posoleucel being evaluated for the
treatment of BKV in adult kidney transplant recipients, the first
demonstration of posoleucel in solid organ transplant patients.
Data demonstrate the safety profile of posoleucel and its antiviral
activity, which is amplified in high viral load patients who have
the greatest unmet need, suggesting it could potentially offer a
transformative treatment option for kidney transplant patients with
BKV.
- Positive long-term follow-up data from the Phase 2 trial
exploring the potential of posoleucel for the prevention of
clinically significant infections were presented at the 49th Annual
Meeting of the European Society for Blood and Marrow
Transplantation (EBMT 2023) in April 2023. These new findings
demonstrate that the high-risk allo-HCT patients who received
posoleucel experienced continued low rates of clinically
significant infections or end-organ disease and 0% non-relapse
mortality. Data continue to substantiate the potential clinical
benefit posoleucel could provide to high-risk allo-HCT
patients.
- In February 2023, a case report of the treatment of refractory
AdV infection in a CAR-T recipient with posoleucel was presented at
the 2023 Tandem Meetings | Transplantation & Cellular Therapy
Meetings of ASTCT and CIBMR (Poster 453). Findings demonstrate that
posoleucel appeared to be safe and effective against devastating
viral infections in patients receiving lymphodepletion chemotherapy
and CAR-T therapy.
- The company announced the appointment of Derek Adams, PhD, a
leading authority in biologic and gene therapies manufacturing, to
its Board of Directors.
Upcoming Highlights/Activities
- The company plans to present comprehensive results from the BKV
Phase 2 study as a late-breaking oral presentation at the American
Transplant Congress (ATC) 2023 and will work with regulatory
authorities and transplant specialists to inform next steps for
this program as well as AlloVir’s broader solid organ transplant
strategy.
First Quarter Financial Highlights
- Research and development expenses were $30.7 million for the
quarter ended March 31, 2023, compared with $29.1 million for the
quarter ended March 31, 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 $12.5 million for the
quarter ended March 31, 2023, compared with $14.1 million for the
quarter ended March 31, 2022. The decrease year-over-year was
primarily attributable to a decrease in consulting and personnel
related costs.
- Stock-based compensation expense was $10.0 million and $10.5
million for the quarter ended March 31, 2023, and 2022,
respectively.
- As of March 31, 2023, AlloVir had cash, cash equivalents, and
short-term investments of $202.6 million, compared with cash, cash
equivalents, and short-term investments of $233.8 million as of
December 31, 2022.
- For the quarter ended March 31, 2023, net loss was $41.2
million or $0.44 per share compared with a net loss of $43.9
million or $0.69 per share for the quarter ended March 31,
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 AlloVir
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 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 Twitter 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 future enrollment status and timing for data readouts
for AlloVir’s three Phase 3 clinical trials, the potential safety
and efficacy of AlloVir’s product candidates, the development and
regulatory status of AlloVir’s 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 (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 annual report on Form 10-K for year ended December 31,
2023 and in its other 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.
ALLOVIR, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (unaudited, in thousands, except share and per
share data) Three Months EndedMarch 31,
2023
2022
Operating expenses: Research and development
30,718
29,067
General and administrative
12,513
14,126
Total operating expenses
43,231
43,193
Loss from operations
(43,231
)
(43,193
)
Total other income (loss), net: Interest income
1,325
148
Other income (loss), net
723
(818
)
Net loss $
(41,183
)
$
(43,863
)
Net loss per share --- basic and diluted $
(0.44
)
$
(0.69
)
Weighted-average common shares outstanding---basic and diluted
93,303,672
63,993,053
ALLOVIR, INC. CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
March 31,
December 31,
2023
2022
Assets Current assets: Cash, cash equivalents and short-term
investments $
202,570
$
233,795
Other current assets
9,705
9,257
Total current assets
212,275
243,052
Other assets
31,769
34,027
Total assets $
244,044
$
277,079
Liabilities and stockholders’ equity Current liabilities $
24,959
$
24,338
Long-term liabilities
25,553
28,222
Total liabilities
50,512
52,560
Total stockholders’ equity
193,532
224,519
Total liabilities and stockholders’ equity $
244,044
$
277,079
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Media and Investor Contact: IR@allovir.com
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