Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today reported financial
results for the fourth quarter and full year ended December 31,
2022 and provided a business update.
“This year, we are poised to continue the
meaningful progress made with our clinical development programs
following strong execution in 2022,” said Jean-Pierre Sommadossi,
PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals.
“We anticipate several significant clinical milestones for our lead
compound, bemnifosbuvir, including an interim analysis from the
Phase 3 SUNRISE-3 trial for COVID-19 followed by completion of
targeted enrollment by year end. In addition, we plan to initiate
patient enrollment in the Phase 2 combination study of
bemnifosbuvir and ruzasvir for HCV next quarter, with topline
results expected by the end of the year.”
“We also have made the business decision to
deprioritize the dengue program to focus on COVID-19 and HCV,”
added Dr. Sommadossi. “We believe AT-752 holds promise for the
treatment of dengue as an oral direct acting antiviral. However, it
has become clear that improved diagnostics are needed to better
identify patients earlier in the course of the disease. In
addition, given the high variability in both treatment and
prophylaxis settings, substantially larger patient sample sizes
would be required for future Phase 2 studies. With the anticipated
long clinical timelines and significant associated cost, we will
focus our resources on the COVID-19 and HCV programs at this
time.”
COVID-19 PROGRAM UPDATE
Bemnifosbuvir (AT-527) for
COVID-19
SUNRISE-3 Global Phase 3 Registrational
Trial of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with
COVID-19: Patient enrollment continues in the
randomized, double-blind, placebo-controlled, global Phase 3
SUNRISE-3 trial evaluating bemnifosbuvir or placebo administered
concurrently with locally available standard of care (SOC). The
study is designed to enroll at least 1,500 high-risk,
non-hospitalized patients with mild or moderate COVID-19 at
clinical trial sites planned in the United States, Europe, Japan
and rest of the world. Patients are being randomized 1:1 to receive
either bemnifosbuvir 550 mg twice-daily (BID) plus locally
available SOC or placebo BID plus locally available SOC for five
days. An interim analysis is expected in the second half of 2023,
with anticipated enrollment completion of the targeted 1,500
patients toward the end of 2023.
This trial is comprised of two patient population
cohorts derived from the type of SOC received. These are 1)
“Supportive Care Population” which will assess bemnifosbuvir as
monotherapy (primary analysis) when the patient does not qualify
for an authorized oral antiviral treatment or is in a region where
oral antivirals are not locally available and 2) “Combination
Antiviral Population” which will assess combination therapy being
bemnifosbuvir plus SOC if the SOC includes treatment with other
COVID-19 antivirals (secondary analysis).
The primary endpoint of the study is all-cause
hospitalization or death through Day 29 in the Supportive Care
Population in at least 1,300 patients. Secondary endpoints in both
the Supportive Care Population and the Combination Antiviral
Population include: COVID-19 complications, medically attended
visits, symptom rebound / relapse and viral load rebound.
The patients being enrolled in SUNRISE-3 trial are
those at the highest risk for COVID-19 disease progression,
consisting of patients ≥ 80 years old, patients ≥ 65 years old with
≥ one major risk factor, and immunocompromised patients ≥ 18 years
old, all regardless of COVID-19 vaccination status.
Favorable Drug Interaction Profile of
Bemnifosbuvir Presented at Conference on Retroviruses and
Opportunistic Infections (CROI): In February, Atea
presented favorable data from three Phase 1 studies of
bemnifosbuvir at CROI. Results from a Phase 1 drug-drug interaction
(DDI) study in healthy participants administering bemnifosbuvir
with midazolam (MDZ), a sensitive CYP3A4 substrate as an index
drug, were highlighted in a poster presentation. In addition,
results from Phase 1 studies in healthy participants assessing
pharmacokinetics with administration of bemnifosbuvir with digoxin
(DIG) and rosuvastatin (ROSU) as P-gp and BCRP/OATP1B1 index drugs,
respectively, were also presented in a poster at the conference.
The results from these studies demonstrated that bemnifosbuvir may
be co-administered with a variety of medications that are commonly
prescribed among high-risk COVID-19 patients without need for dose
modification or discontinuation of the concomitant medication.
COVID-19 Program for Second Generation
Protease Inhibitors: As part of a
multipronged approach against COVID-19, Atea is advancing an
internal program focused on the discovery of second-generation
protease inhibitors that have clinical profiles well suited for
combination with bemnifosbuvir for the treatment of COVID-19. Atea
has conducted in vitro studies examining the combination of
bemnifosbuvir with the protease inhibitor nirmatrelvir in an
HCoV-229E surrogate model. The results of these studies indicated
an additive antiviral effect. These data support the potential
activity of the combination of bemnifosbuvir and a protease
inhibitor for the treatment of SARS-CoV-2
infection.
Atea’s target profile for a protease inhibitor is a
compound that is highly potent, has a favorable safety profile with
limited drug-drug interactions and does not require a
pharmacokinetic booster (e.g., ritonavir). Compound selection
activities are underway in anticipation of filing an
investigational new drug application for a clinical candidate
around year end 2023.
Hepatitis C Virus (HCV) Program
Update
Phase 2 HCV Combination Program:
For the treatment of HCV, Atea is advancing the combination of
bemnifosbuvir and ruzasvir (RZR), an oral NS5A inhibitor, in Phase
2 development. This combination has a best-in-class profile with
the potential to improve the current standard of care by offering a
shorter duration, protease inhibitor-free treatment for patients
with HCV.
Highly potent antiviral activity of both
bemnifosbuvir and RZR administered separately in clinical trials in
combination with other drugs for HCV has already been demonstrated.
Additionally, Atea has shown in an in vitro model that the
combination of bemnifosbuvir and RZR had synergistic antiviral
effect inhibiting HCV replication.
Regulatory submissions for the initiation of an
open label Phase 2 combination study of bemnifosbuvir and RZR are
ongoing and dosing of patients in this clinical trial is expected
to begin during the second quarter of 2023. Initial data from a
lead-in cohort of approximately 60 patients is anticipated in the
fourth quarter of 2023.
This open label Phase 2 study is expected to enroll
approximately 280 HCV-infected, direct-acting antiviral naive
patients across all genotypes, including the 60 patient lead-in
cohort. Patients will be administered 550 mg bemnifosbuvir in
combination with 180 mg RZR once-daily for eight weeks. The primary
endpoints of the study are safety and sustained virologic response
(SVR) at Week 12 post-treatment. Other virologic endpoints include
virologic failure, SVR at Week 24 post-treatment and
resistance.
Dengue Program Update
Atea has been a pioneer in the development of an
oral antiviral therapeutic for dengue. The proof-of-concept,
DEFEND-2, demonstrated that AT-752 treatment led to a faster
resolution of fever, the major clinical sign of dengue. However,
DEFEND-2 also highlights the need for better diagnostics to
identify patients earlier in the course of their disease and a
large sample size to account for high patient variability for
treatment and prophylaxis. To address these factors, robust Phase 2
studies would require long clinical timelines with major associated
costs, which has led to the business decision to deprioritize the
dengue program.
DEFEND-2 Results: DEFEND-2 was a
randomized, double-blind, placebo-controlled trial evaluating
AT-752 750 mg three times a day (TID) or placebo TID for 5 days in
dengue endemic countries. The study enrolled adult patients with a
positive dengue test (NS1 Ag or PCR) for any one of four known
serotypes and fever for no more than 48 hours before study entry.
Study objectives included antiviral activity, safety, and
pharmacokinetics with a primary endpoint of change in dengue virus
viral load from baseline and exploratory endpoints of viremia, NS1
levels, and fever reduction.
Cohort 1 enrolled 21 dengue-infected patients
(AT-752 n=14, placebo n=7). Based on their viremia levels at
baseline, patients appear to have presented too late in the course
of the disease. The primary endpoint of change in dengue viral load
was unevaluable since the majority of patients in the placebo arm
had viremia levels which were low or below the lower limit of
quantification at baseline. Variability in viral kinetics
associated with multiple serotypes (1-4) also contributed to the
difficulty in evaluating the virologic results. Importantly,
platelets were also low at baseline for most patients further
highlighting the late clinical presentation. In patients who
presented with body temperature above 37°C, the median time to
fever resolution was 4 days in the AT-752 arm and greater than 5
days in the placebo arm (prespecified exploratory endpoint). In
addition, there was a difference in body temperature change from
baseline of 0.9 ℃ at Day 3 in favor of the AT-752 arm as
compared to the placebo arm (post-hoc analysis). Also at Day
3, 100% of patients who presented with baseline body temperature
above 37°C had a reduction in body temperature below their baseline
levels in the AT-752 arm, versus only 33% of patients in the
placebo arm.
In this study, AT-752 demonstrated a favorable
safety and tolerability profile with no drug related serious
adverse events (SAEs). Two non-drug related SAEs (hospitalizations
due to thrombocytopenia and progression to severe dengue) occurred,
1/7 in the placebo arm and 1/14 in the AT-752 arm. Non-serious
adverse events were mostly mild or moderate, self-limiting and
occurred in comparable frequency in active and placebo arms.
AT-752 Human Challenge Infection Model
Study Results: The challenge study was a randomized,
placebo-controlled study evaluating healthy subjects who were
challenged with a Dengue Virus-1 Live Attenuated Virus strain after
receiving AT-752 dosed 750 mg TID or placebo. The results of the
study in 5 healthy volunteers were uninterpretable due to the high
variability observed in terms of viremia, antigenemia and the
onset/severity of symptoms as well as low drug exposures due to
lack of dosing compliance. It is anticipated that a larger sample
size (n=>50) would be needed in this model to evaluate AT-752
adequately.
Fourth Quarter and Full Year 2022 Financial
Results
Cash, Cash Equivalents and Marketable
Securities: $646.7 million at December 31, 2022 compared
to $764.4 million at December 31, 2021.
Research and Development Expenses:
Research and development expenses were $27.5 million and $81.9
million for the fourth quarter and full year 2022, respectively,
compared to $57.8 million and $167.2 million for the corresponding
periods in 2021. The decrease in research and development expenses
was primarily due to the elimination of the cost share arrangement
with Roche, our former COVID-19 program collaborator. In addition,
Atea recorded a $25.0 million expense during the fourth quarter
2021 due to an upfront payment related to the in-license of
ruzasvir from Merck. Partially offsetting the decrease
in research and development expenses was an increase related to
salaries, benefits and stock-based compensation expense for Atea’s
research and product development employees and consulting fees and
other research and development expenses.
General and Administrative
Expenses: General and administrative expenses remained
relatively consistent at $12.4 million and $48.7 million for the
fourth quarter and full year 2022, respectively, compared to $13.2
million and $45.8 million for the corresponding periods in
2021.
Interest Income and Other, Net:
Interest income and other, net was $5.6 million and $11.2 million
for the fourth quarter and full year 2022, respectively, compared
to less than $0.1 million and $0.2 million for the corresponding
periods in 2021. The increase was primarily the result of investing
in higher yield marketable securities and higher interest
rates.
Income Taxes: Income tax expense
was $0.1 million and income tax benefit was $3.6 million for the
fourth quarter and full year 2022, respectively, compared to income
tax expense of $4,100 and $17,400 for the corresponding periods in
2021. The tax benefit for the full year 2022 was primarily the
result of changes in estimates between the original provision for
2021 income taxes and the actual amounts reflected in the income
tax returns as filed. During 2021, Atea had a tax liability and
recorded income tax expense on income resulting from revenue
recorded from our former collaboration with Roche.
|
|
Condensed Consolidated Statement of Operations and
Comprehensive Loss(in thousands except share and per share
amounts) |
|
|
|
|
|
Three Months Ended December
31, |
|
Year EndedDecember 31, |
|
2022(unaudited) |
2021(unaudited) |
|
2022(unaudited) |
|
|
2021 |
|
Collaboration revenue |
$ |
— |
|
|
$ |
192,180 |
|
|
$ |
— |
|
|
$ |
351,367 |
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
Research and development |
|
27,540 |
|
|
|
57,811 |
|
|
|
81,936 |
|
|
|
167,205 |
|
General and administrative |
|
12,359 |
|
|
|
13,188 |
|
|
|
48,714 |
|
|
|
45,785 |
|
Total operating expenses |
|
39,899 |
|
|
|
70,999 |
|
|
|
130,650 |
|
|
|
212,990 |
|
|
|
|
|
|
|
Income (loss) from
operations |
|
(39,899 |
) |
|
|
121,181 |
|
|
|
(130,650 |
) |
|
|
138,377 |
|
Interest income and other,
net |
|
5,591 |
|
|
|
51 |
|
|
|
11,151 |
|
|
|
213 |
|
Income (loss) before income
taxes |
|
(34,308 |
) |
|
|
121,232 |
|
|
|
(119,499 |
) |
|
|
138,590 |
|
Income tax benefit (expense) |
|
(123 |
) |
|
|
(4,100 |
) |
|
|
3,590 |
|
|
|
(17,400 |
) |
Net income (loss) |
$ |
(34,431 |
) |
|
$ |
117,132 |
|
|
$ |
(115,909 |
) |
|
$ |
121,190 |
|
Unrealized gain (loss) on
available for sale investments |
|
171 |
|
|
|
— |
|
|
|
(684 |
) |
|
|
— |
|
Comprehensive income (loss) |
$ |
(34,260 |
) |
|
$ |
117,132 |
|
|
$ |
(116,593 |
) |
|
$ |
121,190 |
|
Net income (loss) per share
attributable to common stockholders |
|
|
|
|
|
Basic |
$ |
(0.41 |
) |
|
$ |
1.41 |
|
|
$ |
(1.39 |
) |
|
$ |
1.46 |
|
Diluted |
$ |
(0.41 |
) |
|
$ |
1.34 |
|
|
$ |
(1.39 |
) |
|
$ |
1.37 |
|
Weighted-average common shares
outstanding |
|
|
|
|
|
Basic |
|
83,287,639 |
|
|
|
83,095,320 |
|
|
|
83,245,385 |
|
|
|
82,820,037 |
|
Diluted |
|
83,287,639 |
|
|
|
87,092,688 |
|
|
|
83,245,385 |
|
|
|
88,249,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Condensed Consolidated Balance Sheet
Data |
(in thousands) |
|
|
|
|
|
December 31, 2022 |
|
December 31, 2021 |
|
(unaudited) |
|
|
Cash, cash equivalents and marketable securities |
$ |
646,709 |
|
$ |
764,375 |
Working capital (1) |
|
642,444 |
|
|
715,520 |
Total assets |
|
666,708 |
|
|
772,892 |
Total liabilities |
|
26,136 |
|
|
62,815 |
Total stockholders’
equity |
|
640,572 |
|
|
710,077 |
|
|
|
|
|
|
(1) Atea defines
working capital as current assets less current liabilities. See
Atea’s consolidated financial statements in its Annual Report on
Form 10-K for the year ended December 31, 2022, to be filed
February 28, 2023, for further detail regarding its current assets
and liabilities. |
|
|
Conference Call and Webcast
Atea will host a conference call and live audio
webcast to discuss fourth quarter and full year 2022 financial
results and provide a business update today at 4:30 p.m. ET. To
access the live conference call, please register here. A live audio
webcast of the call and accompanying slide presentation will also
be available in the Investors’ Events & Presentations section
of the Company's website, www.ateapharma.com. An archived webcast
will be available on the Atea website approximately two hours after
the event.
About Atea PharmaceuticalsAtea is
a clinical stage biopharmaceutical company focused on discovering,
developing and commercializing oral therapies to address the unmet
medical needs of patients with serious viral infections. Leveraging
the Company’s deep understanding of antiviral drug development,
nucleos(t)ide chemistry, biology, biochemistry and virology, Atea
has built a proprietary nucleos(t)ide prodrug platform to develop
novel product candidates to treat single stranded ribonucleic acid,
or ssRNA, viruses, which are a prevalent cause of serious viral
diseases. Atea plans to continue to build its pipeline of antiviral
product candidates by augmenting its nucleos(t)ide platform with
other classes of antivirals that may be used in combination with
its nucleos(t)ide product candidates. Currently, Atea is focused on
the development of orally-available antiviral agents for serious
viral infections, including severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and
hepatitis C virus (HCV). For more information, please visit
www.ateapharma.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
that do not relate to matters of historical fact should be
considered forward-looking statements, including without limitation
statements regarding our expectations surrounding the potential of
our product candidates, including bemnifosbuvir combination product
candidates, and expectations regarding our pipeline, including
trial design and development timelines. These statements are
neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the uncertainty around and costs associated
with the clinical development of bemnifosbuvir as a potential
treatment for COVID-19 and the combination of bemnifosbuvir and
ruzasvir as a potential treatment for HCV. These and other
important factors discussed under the caption “Risk Factors” in our
Annual Report on Form 10-K for the year ended December 31, 2022 and
our other filings with the SEC could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking statements
represent management’s estimates as of the date of this press
release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
Contacts
Jonae BarnesSVP, Investor Relations and Corporate
Communications617-818-2985Barnes.jonae@ateapharma.com
Will O’ConnorStern Investor Relations
212-362-1200will.oconnor@sternir.com
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