-- 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 $213.3 million
providing runway through all pivotal trial data readouts
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T
cell immunotherapy company, today reported financial results from
the third quarter ended September 30, 2023. AlloVir continues to
progress its highly innovative lead therapeutic candidate,
posoleucel, by enrolling globally in three Phase 3 trials for
first-to-market indications. AlloVir is in a position of strength
with significant financial resources to support operations through
topline data readouts for all three trials anticipated in the
second half of 2024.
“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 for the
quarter ended September 30, 2023, compared with $30.0 million for
the quarter ended September 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 ended September 30, 2023, compared with
$12.9 million for the quarter ended September 30, 2022.
- Stock-based compensation expenses were $10.5 million and $10.9
million for the quarter ended September 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
of December 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 ended September 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
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, 88% of allo-HCT patients who received
posoleucel remained free of clinically significant infections
through week 14, the primary endpoint. Moreover, the non-relapse
mortality rate in patients who received posoleucel was 0% through
the 52-week follow-up visit. Additionally, in the positive Phase 2
proof-of-concept CHARMS treatment study, which enrolled allo-HCT
recipients infected by one or more of the six viruses posoleucel
targets, more than 90% of patients who failed conventional
treatment and received posoleucel demonstrated a complete or
partial clinical response based on predefined criteria.
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 U.S. Food and Drug
Administration (FDA), or other foreign regulatory authorities,
competition from other biopharmaceutical companies, supply chain,
and business operations and other risks identified in AlloVir's SEC
filings, including AlloVir’s form 10-Q for the period ended June
30, 2023. 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) 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 EndedSeptember 30,
Nine Months EndedSeptember 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
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Media and Investor: ir@allovir.com
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