Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today reported financial
results for the first quarter ended March 31, 2022 and provided a
business update.
“We are very pleased to report new bemnifosbuvir data, showing
for the first time, clinical benefits in two placebo-controlled
trials, which were recently closed out. These new results show a
meaningful reduction in hospitalization in a broad patient
population treated in the MORNINGSKY outpatient trial and suggest
potential clinical benefits in the Phase 2 high-risk hospitalized
trial. In addition, new in vitro data demonstrate the broad
antiviral activity of bemnifosbuvir across variants of concern,
including Omicron,” said Jean-Pierre Sommadossi, PhD, Chief
Executive Officer and Founder of Atea Pharmaceuticals. “With the
bemnifosbuvir results to-date, including clinical benefits,
favorable safety and tolerability data, we are pursuing
interactions with regulatory authorities to review our data package
and to discuss the next steps in our COVID-19 clinical development
program.”
“Beyond COVID-19, we have made significant progress across our
other pipeline programs, including initiation of a global Phase 2
study and a human challenge trial advancing AT-752 as a potential
first antiviral treatment for dengue fever, the most prevalent
mosquito-borne viral disease with a large global disease burden.
Additionally, we continue preparations for the initiation of our
upcoming Phase 2 study in HCV evaluating the combination of
bemnifosbuvir and ruzasvir,” continued Dr. Sommadossi. “The
progress we are making today sets the stage for a number of
important milestones over the next 18 months. Importantly, we
remain well capitalized to advance the clinical development of
these product candidates in our effort to provide new medicines to
patients with severe viral diseases.”
Bemnifosbuvir (AT-527) Program Update for
COVID-19
New Topline Efficacy Results from MORNINGSKY
Trial: In a topline analysis of data from the MORNINGSKY
trial, the primary endpoint, time to symptom alleviation, was not
achieved. However, a 71% reduction in hospitalization (2.9% versus
10%) was observed (p=0.047, unadjusted, exploratory) in the
bemnifosbuvir arm (n=137) versus placebo (n=70). There were no
deaths in the trial. Hospitalization and death are study endpoints
that are currently preferred by the U.S. Food and Drug
Administration and other regulatory authorities.
The study enrolled a broad patient population of whom
approximately 50% were high risk and 50% were standard risk; 28% of
patients were vaccinated; and 56% were seropositive at baseline.
Consistent with previous studies, bemnifosbuvir 550 mg twice-daily
(BID) was generally safe and well tolerated. There were no
drug-related serious adverse events. Adverse events leading to
treatment discontinuation were 3% for bemnifosbuvir versus 7% for
placebo and there were no gastrointestinal-related events leading
to treatment discontinuation.
MORNINGSKY was a randomized, double-blind, multi-center,
placebo-controlled Phase 3 trial evaluating the efficacy, safety,
antiviral activity, and pharmacokinetics of bemnifosbuvir in up to
1,400 patients randomized 2:1 to receive bemnifosbuvir 550 mg BID
or placebo in an outpatient setting. As previously announced, the
study was closed out early in December 2021, having enrolled 216
patients of which 207 were evaluable for efficacy. Atea plans to
present the full results of this study at an upcoming scientific
meeting.
New Data from Final Analysis of Phase 2 Hospitalized
Study in High-Risk Patients: Final clinical results from
the Phase 2 hospitalized study in high-risk patients (n=83) suggest
potential clinical benefits. The overall rate of disease
progression was low, which had an impact on the ability to assess
the primary endpoint of progression of respiratory insufficiency
(PRI) rate. The results showed a 7.5% PRI rate for bemnifosbuvir
550 mg BID versus a 10% PRI rate for placebo (primary endpoint).
The respiratory events associated with progression were less severe
in the bemnifosbuvir treated patients as compared to those
receiving placebo. There were 3 deaths in the study, no deaths were
reported in patients treated with bemnifosbuvir versus 3 deaths
reported with placebo.
Final virology results (secondary endpoint) were consistent with
previously reported interim data from this study. Bemnifosbuvir was
generally safe and well tolerated with no drug related serious
adverse events and no adverse events leading to treatment
discontinuation.
The global Phase 2 trial was a randomized, double-blind,
placebo-controlled, multi-center study to evaluate bemnifosbuvir in
patients with moderate COVID-19 in the hospital setting. The key
inclusion criteria for this study were adult patients 18 years or
older with risk factors such as obesity, diabetes, asthma and
hypertension. Study objectives were to assess safety, tolerability,
clinical and antiviral efficacy. Patients were randomized within
five days of symptom onset to receive either bemnifosbuvir (550 mg
BID in Part A; 1100 mg BID in Part B) or placebo for five days. In
total, 81 patients were randomized in Part A (41 patients in the
550 mg BID arm; 40 patients in placebo arm) and 2 patients were
randomized in Part B (0 patients in 1100 mg BID arm; 2 patients in
placebo arm). The evolving nature of the standard of care resulted
in the in the early close out of the study which limited the Part B
enrollment. Atea plans to present the full results of this study at
an upcoming scientific meeting.
Next Steps for Bemnifosbuvir Clinical Development for
COVID-19: In light of the new MORNINGSKY outpatient data
and the final analysis of the Phase 2 hospitalized study, Atea is
pursuing interactions with regulatory authorities to review the
data package and to discuss the next steps in the bemnifosbuvir
clinical development program for COVID-19.
New In
Vitro Results: AT-511, the free base
of bemnifosbuvir, has been shown to be a potent inhibitor of
SARS-CoV-2 in vitro. New results demonstrate bemnifosbuvir
retained potent antiviral activity against the SARS-CoV-2 variant
Omicron (BA.1). In vitro results evaluating
antiviral activity against all variants of concern and/or of
interest have previously included Alpha, Gamma, Epsilon, Delta.
Publication of Bemnifosbuvir Mechanism Data in
Peer-Reviewed Journal: In February 2022, data
highlighting bemnifosbuvir’s unique dual target mechanism of action
consisting of chain termination (RdRp) and nucleotityltransferase
(NiRAN) inhibition were published in the peer-reviewed
journal Nature Communications.
Nonclinical Bemnifosbuvir Toxicology Data at Society of
Toxicology (SOT) 61st Annual Meeting: Atea’s poster
presentation, which evidenced a favorable overall nonclinical
safety profile for bemnifosbuvir, including lack of reproductive
and development toxicity in animal models, was selected by the SOT
Risk Assessment Specialty Selection Executive Committee as a top
ten abstract this year.
AT-752 Program Update for Dengue
Initiated Phase 2 Dengue Fever Study and Human Challenge
Trial: Atea has initiated the global Phase 2 DEFEND-2
(DEngue Fever
END) study of AT-752 for the treatment of dengue.
The randomized, double-blind, placebo-controlled study will
evaluate multiple doses of AT-752 and enroll up to 60 adult
patients infected with dengue. The primary objective of the study
is to evaluate antiviral activity, with change from baseline in
dengue virus (DENV) viral load as the primary endpoint [DENV RNA by
reverse transcription-polymerase chain reaction (RT-PCR)].
In addition to the DEFEND-2 study, Atea has initiated a dengue
human challenge trial. This trial, which is being conducted
exclusively in the United States, is designed to evaluate the
effect of AT-752 in healthy volunteers who are challenged with an
attenuated DENV-1 virus strain after receiving AT-752 or
placebo.
Results from the human challenge trial are expected in the
fourth quarter of 2022 and initial results from the DEFEND-2 study
are expected in late 2022.
Hepatitis C Virus (HCV) Program Update
Phase 2 HCV Combination Program: In January
2022, Atea announced that it had obtained exclusive worldwide
rights to develop, manufacture and commercialize ruzasvir (RZR), an
oral NS5A inhibitor, through a license agreement with Merck. Atea
is currently manufacturing clinical trial supply of RZR and is
evaluating clinical trial designs for the Phase 2 combination study
of bemnifosbuvir and RZR, which is expected to be initiated in the
second half of 2022. Studies conducted by Atea have shown in vitro
synergy of the combination of bemnifosbuvir and RZR in inhibiting
HCV replication.
First Quarter 2022 Financial Results
Cash and Cash Equivalents: $705.5 million
at March 31, 2022 compared to $764.4 million at December 31, 2021.
In the quarter ended March 31, 2022, cash expenditures included
payment of amounts previously recorded as accrued expenses,
including a payment to Merck in the amount of $25 million in
connection with the license of ruzasvir and a payment in the amount
of $10.4 million in connection with the cost share arrangement with
Roche.
Research and Development
Expenses: Research and development expenses for the
quarter ended March 31, 2022 in the amount of $29.6 million
increased by $3.0 million from $26.6 million for the
quarter ended March 31, 2021. The increase in research and
development expenses was primarily due to the expansion of our
organization and reflected an increase in payroll and
personnel-related expenses, including salaries, benefits and
stock-based compensation expense offset by a decrease in external
research and development expenses.
General and Administrative
Expenses: General and administrative expenses for the
quarter ended March 31, 2022 in the amount of $12.5 million
increased by $3.7 million from $8.8 million for the
quarter ended March 31, 2021. The increase in general and
administrative expenses was primarily due to the expansion of our
organization and reflected an increase in payroll and
personnel-related expenses, including salaries, benefits and
stock-based compensation expense and other general and
administrative expenses.
Net Income (Loss): Net loss for the
quarter ended March 31, 2022 was $42.1 million compared to net
income of $30.7 million for the quarter ended March 31, 2021. The
net loss for the quarter ended March 31, 2022 as compared to net
income for the quarter ended March 31, 2021 resulted principally
from a decrease in revenue of $66.0 million as a result of the
termination of the Roche collaboration and an increase of $6.7
million in operating expenses noted above.
Condensed Consolidated Statement of
Operations and Comprehensive Income (Loss)(in thousands,
except share and per share amounts)(unaudited)
|
Three Months
EndedMarch 31, |
|
|
2022 |
|
|
2021 |
Collaboration revenue |
$ |
— |
|
$ |
65,985 |
Operating expenses |
|
|
Research and development |
|
29,633 |
|
|
26,571 |
General and administrative |
|
12,542 |
|
|
8,759 |
Total operating expenses |
|
42,175 |
|
|
35,330 |
Income
(loss) from operations |
|
(42,175 |
) |
|
30,655 |
Interest
income and other, net |
|
98 |
|
|
58 |
Income
(loss) before income taxes |
|
(42,077 |
) |
|
30,713 |
Income tax expense |
|
— |
|
|
— |
Net
income (loss) and comprehensive income (loss) |
$ |
(42,077 |
) |
$ |
30,713 |
Net
income (loss) per share attributable to common stockholders |
|
|
Basic |
$ |
(0.51 |
) |
$ |
0.37 |
Diluted |
$ |
(0.51 |
) |
$ |
0.34 |
Weighted-average common shares outstanding |
|
|
Basic |
|
83,176,408 |
|
|
82,577,836 |
Diluted |
|
83,176,408 |
|
|
89,099,075 |
Selected Condensed Consolidated Balance
Sheet Data (in thousands, except share and per share
amounts)
|
March 31, 2022 |
|
December 31, 2021 |
|
(unaudited) |
|
|
|
Cash and cash equivalents |
$ |
705,545 |
|
$ |
764,375 |
Working capital(1) |
|
684,622 |
|
|
715,520 |
Total assets |
|
717,189 |
|
|
772,892 |
Total liabilities |
|
37,305 |
|
|
62,815 |
Total stockholders'
equity |
|
679,884 |
|
|
710,077 |
(1) The Company defines working capital as current assets less
current liabilities. See the Company’s condensed consolidated
financial statements in its Quarterly Report on Form 10-Q for the
three months ended March 31, 2022 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 first quarter 2022 financial results and provide a
corporate update today at 8 a.m. ET. To access the live conference
call, please dial (800) 343-5172 (domestic) or (203) 518-9814
(international) at least five minutes prior to the start time and
refer to conference ID: AVIRQ122. 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 Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical
company focused on discovering, developing and commercializing oral
therapies to address the unmet medical needs of patients with
severe diseases. 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 severe 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 difficult-to-treat,
life-threatening viral infections, including severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that
causes COVID-19, hepatitis C virus (HCV), dengue virus and
respiratory syncytial virus (RSV). 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, 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 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, 2021 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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