Completion of enrollment of all three
posoleucel Phase 3 registrational trials for three distinct,
first-to-market indications anticipated by end of 2023 and data
readouts in 2024
Positive final results from randomized,
double-blind, placebo-controlled Phase 2 study of posoleucel in
kidney transplant recipients with BK viremia announced separately
today; company to host investor webcast at 9:00 a.m. EST
Strong cash position, with $233.8 million as of
year-end 2022
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T
cell immunotherapy company, today reported full-year 2022 financial
results for the period ended December 31, 2022. The company also
highlighted its progress and provided the outlook for 2023 and into
2024 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 caused by six viruses that commonly impact
patients following allogeneic hematopoietic cell transplant
(allo-HCT).
“With the acceleration of the posoleucel multi-virus prevention
study and continued enrollment in the viral hemorrhagic cystitis
and adenovirus treatment Phase 3 studies in 2022, the posoleucel
franchise is positioned for potentially significant value creation
over the next 12-24 months,” said Diana Brainard, M.D., Chief
Executive Officer, AlloVir. “During 2023, we plan to complete
enrollment in our Phase 3 registrational studies, which would
enable data readouts in 2024 and, with positive results, regulatory
filings and acceleration of commercial preparations to follow.”
Dr. Brainard continued, “Today we also announced positive final
Phase 2 results from our first study of posoleucel in the solid
organ transplant setting, showing balanced safety across the
posoleucel and placebo groups and clinically meaningful greater
viral load declines with posoleucel versus placebo in kidney
transplant patients with BKV. These results are important proof of
concept for the use of posoleucel in the solid organ transplant
setting. We look forward to working with regulatory authorities and
transplant specialists on our future clinical development plans for
this patient population with high unmet medical need."
Recent Highlights
- In an oral presentation at the American Society of Hematology
(ASH) Annual Meeting and Exposition in December 2022, final data
were presented from the Phase 2 study evaluating posoleucel for the
prevention of clinically significant infections or diseases from
adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human
herpesvirus-6 and JC virus in allo-HCT patients. The data
demonstrated a substantial reduction in the expected rate of
clinically significant viral infections in this high-risk patient
population despite the expected high rates of viral reactivation
observed. Biomarker data showed the persistence of posoleucel and
association between expansion of functional VSTs and viral
control.
- Final topline data from the posoleucel Phase 2 BKV treatment
study in kidney transplant patients were reported earlier today.
Posoleucel was generally well tolerated in the study and
demonstrated clinically meaningful antiviral efficacy consistently
across multiple BK viral load measures. The greatest effect was
observed with biweekly posoleucel dosing in patients with screening
viral load ≥10,000 copies/mL, who are at highest risk for
BKV-associated graft loss.
- In January 2023, final data from the CHARMS Phase 2 study of
posoleucel for the treatment of viral infections in
treatment-refractory allo-HCT patients were published in Clinical
Cancer Research. The data demonstrated that 95% of patients with
one or more treatment-refractory infections achieved a clinical
response with posoleucel.
- A compassionate use case report of posoleucel therapy for BKV
nephropathy in a kidney transplant patient was presented in a
poster at the annual meeting of the American Society of Nephrology
in November 2022. Following posoleucel therapy, the patient
experienced a significant reduction in BK viral load.
- In November 2022, a manuscript was published in Haematologica
describing the development and first clinical use of ALVR109 for
the treatment of COVID-19. The data underscore the company’s
ability to rapidly develop VSTs for emerging viral threats and the
potential application of these VSTs for the treatment of
respiratory viruses.
- In the fourth quarter of 2022, the company established a
scientific advisory board comprised of experts in cell therapies,
stem cell and solid organ transplantation and infectious diseases.
The standing group of advisors will provide insights and external
perspective that will guide the advancement of the company’s
science and pipeline. AlloVir’s scientific advisory board members
are as follows:
- Michael Boeckh, M.D., Ph.D., Head of the
Infectious Disease Sciences Program of the Vaccine and Infectious
Disease Division at Fred Hutchinson Cancer Center
- Anil Chandraker, M.D., Director of Renal
Transplant Medicine at Brigham and Women’s Hospital, and Associate
Professor of Medicine at Harvard Medical School
- Stella Davies, MBBS, Ph.D., MRCP, Director
of the Division of Bone Marrow Transplantation and Immune
Deficiency at Cincinnati Children’s Hospital Medical Center
- John F. DiPersio, M.D., Ph.D., Director of
the Center for Gene and Cellular Immunotherapy and a Professor of
Medicine, Pathology & Immunology at Washington University
School of Medicine
- John W. Mellors, M.D., Distinguished
Professor of Medicine, Chief of Infectious Diseases, and Endowed
Chair for Global Elimination of HIV and AIDS, at the University of
Pittsburgh School of Medicine and UPMC Health System
- Gérard Socié, M.D., Ph.D., Head of
Hematology-Transplantation at AP-HP Hospital Saint-Louis in
Paris
Outlook – 2023 and Into 2024
Posoleucel: AlloVir’s lead investigational therapy, posoleucel,
offers a franchise opportunity, with three indications being
evaluated in Phase 3 registrational trials.
- The posoleucel Phase 3 multi-virus prevention trial is
enrolling adult and pediatric patients globally. Enrollment is
expected to complete by year-end 2023, enabling topline data in
mid-2024.
- Global enrollment is ongoing in Phase 3 studies of posoleucel
for the treatment of virus-associated hemorrhagic cystitis and
adenovirus infection, both in adult and pediatric allo-HCT
patients. Both studies are expected to complete enrollment by
year-end 2023, with topline data anticipated in 2024.
- The company plans to present comprehensive results from the BKV
Phase 2 study at a scientific congress later this year, and will
work with regulatory authorities and transplant specialists to
inform next steps for this program and AlloVir's broader solid
organ transplant strategy.
Earlier Stage Pipeline: AlloVir’s early clinical and preclinical
VST therapy candidates provide portfolio expansion opportunities,
with pipeline advancement led by AlloVir or a potential
partner.
- A Phase 1b/2 proof-of-concept clinical study
of ALVR106 for the treatment of respiratory syncytial virus, human
metapneumovirus, parainfluenza, and influenza, is enrolling auto-
and allo-HCT patients in the U.S. into the dose escalation part of
this two-part study.
- Preclinical and IND-enabling studies of
ALVR107 for chronic HBV have been completed and continue to support
the potential for ALVR107 to achieve functional HBV cure. The
company expects to initiate clinical development of ALVR107 after
completion of the posoleucel Phase 3 registrational studies.
2022 Financial Highlights
- Research and development expenses were $118.9 million for the
year ended December 31, 2022, compared with $120.7 million for the
year ended December 31, 2021. The decrease year-over-year is
primarily attributable to a reduction in costs related to the
outsourcing of manufacturing, offset by an increase in costs
related to the development of clinical trials to advance product
candidates.
- General and administrative expense was $52.3 million for the
year ended December 31, 2022, compared with $49.1 million for the
year ended December 31, 2021. Stock-based compensation expense was
$41.3 million and $44.0 million for the years ended December 31,
2022 and 2021, respectively.
- As of December 31, 2022, AlloVir had cash, cash equivalents,
and marketable securities of $233.8 million, compared with cash,
cash equivalents, and marketable securities of $248.1 million as of
December 31, 2021.
- For the year ended December 31, 2022, net loss was $168.7
million or $2.20 per share, compared with a net loss of $172.0
million or $2.74 per share for the year ended December 31,
2021.
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.
Investor Webcast Details
The company will host an investor webcast today at 9:00 a.m. EST
to discuss the BKV study findings and the potential clinical impact
of using posoleucel to treat viral infections in the solid organ
transplant setting. The webcast will feature remarks from AlloVir
CEO Diana Brainard, M.D., and from renal transplant specialist Anil
K. Chandraker, M.D., Brigham and Women's Hospital.
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.
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 safety, efficacy and regulatory and clinical progress
of our product candidates, including posoleucel, the planned
conduct of its preclinical studies, and clinical trials and its
prospects for success in those studies and trials, the financial
outlook for the full-year 2023, including estimates of operating
expenses, 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 Securities and Exchange Commission
(SEC) filings, including but not limited to the risks discussed in
AlloVir's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2022 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)
December 31,
2022
2021
Assets Current assets: Cash, cash equivalents and short-term
investments $
233,795
$
248,120
Other current assets
9,257
5,228
Total current assets
243,052
253,348
Other assets
34,027
33,246
Total assets $
277,079
$
286,594
Liabilities and stockholders’ equity Current liabilities $
24,338
$
37,853
Long-term liabilities
28,222
23,475
Total liabilities
52,560
61,328
Total stockholders’ equity
224,519
225,266
Total liabilities and stockholders’ equity $
277,079
$
286,594
ALLOVIR, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (unaudited, in thousands, except share and per
share data)
Years Ended December
31,
2022
2021
Operating expenses: Research and development
118,870
120,735
General and administrative
52,332
49,083
Total operating expenses
171,202
169,818
Loss from operations
(171,202)
(169,818)
Total other income (loss), net: Interest income
1,876
1,315
Other income (loss), net
351
(2,452)
Loss before income taxes
(168,975)
(170,955)
Income tax (benefit) expense
(265)
1,007
Net loss $
(168,710)
$
(171,962)
Net loss per share --- basic and diluted $
(2.20)
$
(2.74)
Weighted-average common shares outstanding---basic and diluted
76,654,856
62,782,126
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version on businesswire.com: https://www.businesswire.com/news/home/20230214005894/en/
Media and Investor: Sonia Choi AlloVir
schoi@allovir.com
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