Posoleucel Continues to Advance in Three
Ongoing Multi-National Phase 3 Registrational Trials
Final Data Presentation from Posoleucel Phase 2
Multi-Virus Prevention Study by Year-End
Company to Host Investor Webcast on December 14
with Clinical Trial Investigators on Posoleucel for Prevention of
Viral Infections in Patients Following Allogeneic Stem Cell
Transplant
Final Topline Data from Posoleucel Phase 2
Study for Treatment of BK Viremia in Kidney Transplant Patients on
Track to be Released in Q1 2023
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T
cell immunotherapy company, today reported financial results for
the third quarter ended September 30, 2022, and shared progress
across its allogeneic, off-the-shelf, virus-specific T cell (VST)
programs, including its lead investigational therapy, posoleucel,
for the treatment and prevention of life-threatening infections and
diseases from up to six viruses that commonly impact patients
following allogeneic hematopoietic cell transplant (allo-HCT).
“We are focused on rapidly advancing the ongoing posoleucel
Phase 3 registrational trials, with the goal of delivering a
significant clinical advance for allo-HCT patients who currently
have very limited therapeutic and preventive options for these
common, yet devastating and potentially life-threatening, viral
infections and diseases,” said Diana Brainard, M.D., Chief
Executive Officer, AlloVir. “We are particularly excited to report
final data before year-end from the Phase 2 multi-virus prevention
study, where preliminary results supported the acceleration of our
global Phase 3 study for this potential indication. Preventing
clinically significant viral infections and diseases after allo-HCT
represents the most transformative use of posoleucel.”
Investor Webcast
AlloVir plans to host an investor webcast on Wednesday, December
14 at 4:30 p.m. ET, to discuss the unmet medical need for and
clinical value of a multi-virus prevention approach in the
management of allo-HCT patients. The webcast will feature remarks
from CEO Diana Brainard; infectious disease specialist Sanjeet
Singh Dadwal, M.D., City of Hope; and hematologist-oncologist and
transplant specialist Joseph McGuirk, D.O., University of Kansas
Medical Center.
A live audio webcast of the presentation will be available on
the Investors & Press section of the AlloVir website at
https://ir.allovir.com/events-and-presentations. An archived replay
of the presentation will be available on the website for 30 days
following the event.
Recent Highlights
- The Phase 3 study of posoleucel for the prevention of
clinically significant infections and end-organ disease from
posoleucel’s six target viruses in high-risk allo-HCT patients,
continued to expand, with ongoing patient enrollment in the U.S.,
Europe and Asia. The multi-virus prevention study evaluates the use
of posoleucel either as prophylactic therapy in patients without
viremia or preemptive therapy for patients who have reactivated one
or more of the target viruses: adenovirus (AdV), BK virus (BKV),
cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes
virus-6 (HHV-6) and JC virus (JCV). Multi-virus prevention has the
potential to transform the management of allo-HCT patients, who
currently have limited to no approved treatment or prevention
options for these devastating infections that threaten patient
survival.
- Enrollment in the posoleucel Phase 3 treatment trials also
continues to progress, with virus-associated hemorrhagic cystitis
trial sites at leading transplant centers in the U.S., Europe and
Asia, and adenovirus trial sites at leading centers in the U.S. and
Europe, with a focus on the pediatric patient population.
- Pediatric data from the CHARMS Phase 2 study of posoleucel for
the treatment of severe, drug-refractory viral infections in
pediatric allo-HCT patients were presented in a poster (Abstract
2161) at IDWeek in October 2022. The data continue to support the
potential of posoleucel as a treatment for viral infections and
diseases in this patient population.
- In July 2022, the European Medicines Agency confirmed that the
orphan medicinal product designation granted to posoleucel to treat
viral infections and diseases from AdV, BKV, CMV, EBV, and HHV-6 in
allo-HCT patients also applies to the potential prevention of
infections or disease by these multiple viruses in this patient
population. Posoleucel previously received Regenerative Medicine
Advanced Therapy (RMAT) designation from the U.S. Food and Drug
Administration for multi-virus prevention, the treatment of AdV
infection and the treatment of virus-associated hemorrhagic
cystitis in adults and children, all following allo-HCT. To the
Company’s knowledge, posoleucel is the only cell or gene therapy
with three RMAT designations.
- In July 2022, The European Patent Office granted Baylor College
of Medicine a patent licensed to AlloVir covering VST compositions
including posoleucel and ALVR106, enhancing the company’s
intellectual property protections in Europe.
Upcoming Highlights/Activities
- Final data from the Phase 2 study of posoleucel for multi-virus
prevention in high-risk allo-HCT patients will be presented at a
medical conference before year-end.
- A compassionate use case report of posoleucel therapy for BKV
nephropathy in a kidney transplant patient will be presented in a
poster (Abstract SA-PO849) at Kidney Week 2022, the annual meeting
of the American Society of Nephrology, on November 5. Following
posoleucel therapy, the patient experienced a significant reduction
in BK viral load.
- Final topline data from the Phase 2 study of posoleucel for the
treatment of BK viremia in kidney transplant patients are expected
to be reported in the first quarter of 2023. The study is the first
to evaluate posoleucel in solid organ transplant patients, with the
primary goal of understanding the safety of posoleucel therapy in
this patient population with more sustained immunosuppression
versus allo-HCT patients.
Third Quarter Financial Highlights
- Research and development expenses were $30.0 million for the
quarter ended September 30, 2022, compared with $33.1 million for
the quarter ended September 30, 2021. The decrease year-over-year
is primarily attributable to a reduction in costs related to the
outsourcing of manufacturing.
- General and administrative expenses were generally consistent
year-over-year, with $12.9 million for the quarter ended September
30, 2022, compared with $12.4 million for the quarter ended
September 30, 2021.
- Stock-based compensation expense was $10.9 million and $10.3
million for the quarter ended September 30, 2022, and 2021,
respectively.
- As of September 30, 2022, AlloVir had cash, cash equivalents,
and marketable securities of $264.1 million, compared with $248.1
million as of December 31, 2021. In July of 2022, AlloVir received
aggregate net proceeds of $126.4 million from a registered direct
offering.
- For the quarter ended September 30, 2022, net loss was $42.1
million or $0.50 per share, compared with a net loss of $45.5
million or $0.72 per share for the quarter ended September 30,
2021.
2022 Financial Guidance
- For fiscal year 2022, AlloVir continues to expect operating
expenses to be in the range of $130 million to $145 million,
excluding non-cash stock compensation 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 AlloVir’s development and regulatory status of our
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, or 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 SEC filings, including but not
limited to the risks discussed in AlloVir's Annual Report on Form
10-K for the year ended December 31, 2021, and in our other filings
with the SEC. 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 BALANCE
SHEETS (unaudited, in thousands) September
30, December 31,
2022
2021
Assets Current assets: Cash, cash equivalents and short-term
investments $
264,107
$
248,120
Other current assets
7,935
5,228
Total current assets
272,042
253,348
Other assets
21,656
33,246
Total assets $
293,698
$
286,594
Liabilities and stockholders’ equity Current liabilities $
20,719
$
37,853
Long-term liabilities
19,753
23,475
Total liabilities
40,472
61,328
Total stockholders’ equity
253,226
225,266
Total liabilities and stockholders’ equity $
293,698
$
286,594
ALLOVIR, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (unaudited, in thousands, except share and per
share data) Three Months EndedSeptember 30,
Nine Months EndedSeptember 30,
2022
2021
2022
2021
Operating expenses: Research and development
30,004
33,062
90,450
79,132
General and administrative
12,946
12,442
40,318
34,890
Total operating expenses
42,950
45,504
130,768
114,022
Loss from operations
(42,950)
(45,504)
(130,768)
(114,022)
Total other income (loss), net: Interest income
668
253
978
1,233
Other income (loss), net
210
(259)
(634)
(1,232)
Loss before income taxes
(42,072)
(45,510)
(130,424)
(114,021)
Income tax expense
-
-
150
-
Net loss $
(42,072)
$
(45,510)
$
(130,574)
$
(114,021)
Net loss per share --- basic and diluted $
(0.50)
$
(0.72)
$
(1.83)
$
(1.82)
Weighted-average common shares outstanding---basic and diluted
84,948,837
62,962,434
71,213,219
62,588,898
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version on businesswire.com: https://www.businesswire.com/news/home/20221103005540/en/
Media and Investor Contact: Sonia Choi AlloVir
schoi@allovir.com
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