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,
2021 and provided a business update.
“During 2022, we expect to make meaningful progress advancing
three Phase 2 programs in COVID-19, HCV and dengue fever,” said
Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Atea Pharmaceuticals. “For COVID-19, our priority is to develop a
combination regimen with bemnifosbuvir and a protease inhibitor. We
believe that combination therapies will be needed to treat broader
patient populations, as new COVID-19 variants occur, and viral drug
resistance will likely emerge to protease inhibitor monotherapy.
Nucleos(t)ide analogs target a highly conserved enzyme responsible
for viral replication and have a higher barrier to resistance than
drugs in other antiviral classes.”
“The recent in-licensing of RZR
expands our pipeline and accelerates the timeline of our HCV
program with a Phase 2-ready NS5A inhibitor. We believe that the
combination of RZR and bemnifosbuvir has the potential to be a
best-in-class pan-genotypic combination regimen to help fight the
increase in HCV infections caused by the opioid crisis, IV drug use
and HCV reinfection,” continued Dr. Sommadossi. “Additionally, we
are making significant progress 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. We
are planning to launch the Phase 2 trial for AT-752 in the first
half of the year.”
“Looking forward, we anticipate several important milestones and
data readouts from our programs during the year. Importantly, we
have the financial strength and a seasoned management team to
advance these programs through key clinical and regulatory
inflection points,” concluded Dr. Sommadossi.
Bemnifosbuvir (AT-527) Program
Update for COVID-19
Bemnifosbuvir Combination
Program: Atea is conducting in vitro studies evaluating
the combination of bemnifosbuvir with selected protease inhibitors
to explore antiviral synergy and mitigation of potential viral drug
resistance. Data from these ongoing in vitro studies will be the
foundation for the Phase 2 clinical development of bemnifosbuvir in
combination with a protease inhibitor.
Bemnifosbuvir Development Summary: In 2021,
Atea reported data from two monotherapy Phase 2 clinical trials
evaluating bemnifosbuvir for the treatment of COVID-19. One study
was conducted in hospitalized adult high-risk patients with
moderate COVID-19, while the second was conducted in adult
outpatients with mild/moderate disease (MOONSONG). Although the
Phase 2 MOONSONG trial did not meet its primary endpoint and the
Phase 2 hospitalized study was closed out prior to completion,
there were consistent positive trends in antiviral activity (~0.5
log10 reductions) observed after dosing with 550 mg twice daily
(BID) and 1100 mg BID in sub-groups of patients at high risk for
disease progression in exploratory analyses. In addition, results
from a bronchoalveolar lavage study in healthy subjects showed that
bemnifosbuvir was efficiently delivered to the lungs (epithelial
lining fluid), the primary site of SARS-CoV-2 infection.
Collectively, these data provide positive human proof-of-concept
antiviral activity data that support a combination strategy.
In December 2021, Atea announced that based on the changing
COVID-19 landscape, the global Phase 3 MORNINGSKY trial would be
closed out and the focus of the COVID-19 program would shift to
development of combination therapy with bemnifosbuvir as its
backbone.
Publication of Bemnifosbuvir Mechanism Data in
Peer-Reviewed Journal: In February 2022, new data
highlighting bemnifosbuvir (AT-527) were published in the
peer-reviewed journal Nature Communications. The published
data demonstrate bemnifosbuvir’s unique mechanism of action showing
dual targets consisting of chain termination (RdRp) and
nucleotityltransferase (NiRAN) inhibition.
In Vitro Results Demonstrate AT-527 Is
Active Against Different SARS-CoV-2 Variants: AT-511, the
free base of AT-527, has been shown to be a potent inhibitor of
SARS-CoV-2 in vitro. Results evaluating antiviral activity against
variants of concern and/or of interest, including Alpha, Gamma,
Epsilon, Delta and others showed that AT-511 maintained its potency
against all the variants tested to-date. These data confirm the key
mechanistic advantage of the compound, which targets the highly
conserved viral RNA polymerase.
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 RZR, an oral NS5A
inhibitor, through a license agreement with Merck. Atea plans to
initiate a Phase 2 combination study of bemnifosbuvir and RZR in
the second half of 2022. Studies conducted by Atea have shown in
vitro synergy of the combination of bemnifosbuvir/RZR in inhibiting
HCV replication.
Since RZR is a Phase 2-ready NS5A inhibitor, Atea has
prioritized clinical development of the bemnifosbuvir/RZR
combination program due to its more advanced stage of development
over the AT-777/AT-787 program. AT-777 was Atea’s former lead NS5A
inhibitor program, which was paused at the onset of COVID-19 due to
industry-wide challenges impacting the conduct of clinical studies
at that time.
RZR Development for
HCV: RZR has demonstrated potent antiviral activity in the
picomolar range in preclinical studies. Clinical studies of RZR
conducted by Merck showed a > 3 log10 viral load decline in
HCV-infected patients as monotherapy. In Merck studies, RZR was
administered to over 1,200 HCV-infected patients at daily doses of
up to 180 mg for up to 24 weeks. In these studies, RZR was
generally well tolerated, and the overall safety data showed no
consistent treatment-related changes in vital signs,
electrocardiogram safety parameters or laboratory parameters. Atea
believes RZR’s pharmacokinetic (PK) profile supports once-daily
dosing.
Bemnifosbuvir Development for HCV: In studies
conducted by Atea, bemnifosbuvir has been shown to be approximately
10-fold more active than sofosbuvir (SOF) in vitro against a panel
of laboratory strains and clinical isolates of HCV genotypes 1–5.
In vitro studies demonstrated bemnifosbuvir remained fully active
against SOF resistance-associated strains (S282T), with up to
58-fold more potency than SOF. Bemnifosbuvir has been shown to be
generally well tolerated in more than 480 subjects (including
healthy volunteers and patients with HCV or COVID-19). Atea
believes bemnifosbuvir’s PK profile supports once-daily dosing for
the treatment of HCV.
Recent AT-752 Program Update
Phase 2 Dengue Program: Atea plans to initiate
a Phase 2 clinical trial in dengue endemic countries and a human
challenge study in the U.S. during the first half of 2022. Atea
expects to report results from these studies in late 2022.
Successful Completion of Phase 1 Clinical Trial of
AT-752: In December 2021, Atea completed a Phase 1
clinical trial demonstrating that AT-752 was well tolerated in 65
healthy subjects who were administered either single or multiple
doses. No premature discontinuations due to adverse events or
serious adverse events were reported. Most adverse events were mild
and there were no changes in laboratory parameters.
Publication of In Vitro
and In Vivo Data of
AT-752 in Peer-Reviewed Journals: In August 2021, data
demonstrating the in vitro and in vivo activity of AT-752 against
dengue virus infection was published in the peer-reviewed journal
Antimicrobial Agents and Chemotherapy. The published data show
AT-752 had potent in vitro antiviral activity against all dengue
virus serotypes and other flaviviruses tested. AT-752 was also
shown to reduce viremia and improve animal health and survival in a
mouse model of dengue virus.
In January 2022, data demonstrating
the in vivo efficacy of AT-752 against yellow fever virus was
published in the peer-reviewed journal PLOS Neglected Tropical
Diseases. The published data show that AT-752 reduced viremia and
improved disease outcomes in a hamster model of yellow fever
virus.
Corporate Updates
Senior Management
Appointment: In February 2022, Atea announced the
appointment of Nancy Gail Berry Agrawal, PhD, as Executive Vice
President of Preclinical Development. Prior to joining Atea, Dr.
Agrawal spent more than 25 years in roles of increasing
responsibility at Merck & Co. Inc., and most recently served as
Vice President of Pharmacokinetics, Pharmacodynamics, and Drug
Metabolism.
Strategic
Collaboration: In November 2021, Atea announced that the
strategic collaboration pursuant to which it was jointly developing
bemnifosbuvir for the treatment of COVID-19 with Roche was being
terminated. The termination was effective as February 10, 2022. As
a result, the rights and licenses granted to Roche by Atea under
the strategic collaboration have terminated and Atea has full
rights to continue the clinical development and future
commercialization of bemnifosbuvir on a worldwide basis.
Fourth Quarter and Full Year
2021 Financial Results
Cash and Cash Equivalents: $764.4 million at
December 31, 2021 compared to $850.1 million at December 31,
2020.
Revenue: Collaboration revenue was $192.2
million and $351.4 million for the fourth quarter and full year
2021, respectively, compared to $48.6 million and $48.6 million for
the corresponding periods in 2020. All collaboration revenue was
derived from the Roche License Agreement, which was entered into in
October 2020. Upon notice of termination in November 2021, the
Company recognized all remaining deferred revenue related to the
Roche License Agreement.
Research and Development Expenses: Research and
development expenses were $57.8 million and $167.2 million for the
fourth quarter and full year 2021, respectively, compared to $13.8
million and $38.0 million for the corresponding periods in 2020.
The increase in research and development expenses was primarily due
to an increase in external expenses related to the contract
research organization and contract manufacturing organization
services in conjunction with the advancement of product candidates
for the treatment of COVID-19 and dengue fever. The research and
development expenses include Atea’s share of costs incurred by
Roche and increases in internal spend primarily due to an increase
in personnel-related expenses, including salaries, benefits and
stock-based compensation expense for the Company’s research and
product development employees and consulting fees and other
research and development expenses. In addition, the Company
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.
General and Administrative Expenses: General
and administrative expenses were $13.2 million and $45.8 million
for the fourth quarter and full year 2021, respectively, compared
to $14.1 million and $21.6 million for the corresponding periods in
2020. The increase in general and administrative expenses was
primarily due to the expansion of the Company’s 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, partially offset by
a $7.0 million fee paid during the fourth quarter of 2020 in
connection with the Roche License Agreement.
Income Taxes: Income
taxes were $4.1 million and $17.4 million for the fourth quarter
and full year 2021, respectively, compared to $0 and $0 for the
corresponding periods in 2020. The increase in income tax was
primarily due to realization of income as a result of the
recognition of revenue in 2021 associated with the Roche License
Agreement.
Net Income (loss): Net income was $117.1
million and $121.2 million for the fourth quarter and full year
2021, compared to net income of $20.7 million and net loss of $10.9
million for the corresponding periods in 2020.
|
Condensed Consolidated Statement of Operations and
Comprehensive Loss(in thousands except share and per share
amounts) |
|
Three Months Ended December
31, |
|
Year EndedDecember 31, |
|
2021(unaudited) |
2020(unaudited) |
|
2021(unaudited) |
|
2020 |
|
Collaboration revenue |
$ |
192,180 |
|
$ |
48,633 |
|
|
$ |
351,367 |
|
$ |
48,633 |
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
Research and development |
|
57,811 |
|
|
13,846 |
|
|
|
167,205 |
|
|
38,023 |
|
General and administrative |
|
13,188 |
|
|
14,140 |
|
|
|
45,785 |
|
|
21,640 |
|
Total operating expenses |
|
70,999 |
|
|
27,986 |
|
|
|
212,990 |
|
|
59,663 |
|
|
|
|
|
|
|
Income (loss) from
operations |
|
121,181 |
|
|
20,647 |
|
|
|
138,377 |
|
|
(11,030 |
) |
Interest income and other,
net |
|
51 |
|
|
9 |
|
|
|
213 |
|
|
83 |
|
Income (loss) before income
taxes |
|
121,232 |
|
|
20,656 |
|
|
|
138,590 |
|
|
(10,947 |
) |
Income taxes |
|
4,100 |
|
|
— |
|
|
|
17,400 |
|
|
— |
|
Net income (loss) and
comprehensive income (loss) |
$ |
117,132 |
|
$ |
20,656 |
|
|
$ |
121,190 |
|
$ |
(10,947 |
) |
Net income (loss) per share
attributable to common stockholders |
|
|
|
|
|
Basic |
$ |
1.41 |
|
$ |
0.37 |
|
|
$ |
1.46 |
|
$ |
(0.51 |
) |
Diluted |
$ |
1.34 |
|
$ |
0.25 |
|
|
$ |
1.37 |
|
$ |
(0.51 |
) |
Weighted-average common shares
outstanding |
|
|
|
|
|
Basic |
|
83,095,320 |
|
|
56,198,542 |
|
|
|
82,820,037 |
|
|
21,592,441 |
|
Diluted |
|
87,092,688 |
|
|
81,731,329 |
|
|
|
88,249,243 |
|
|
21,592,441 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Condensed Consolidated Balance Sheet Data |
(in thousands except share and per share amounts) |
|
|
December 31, 2021 |
|
December 31, 2020 |
|
|
(unaudited) |
|
|
Cash and cash equivalents |
|
$ |
764,375 |
|
$ |
850,117 |
Working capital (1) |
|
|
715,520 |
|
|
547,682 |
Total assets |
|
|
772,892 |
|
|
863,632 |
Total liabilities |
|
|
62,815 |
|
|
315,831 |
Total stockholder's equity |
|
|
710,077 |
|
|
547,801 |
(1) The Company
defines working capital as current assets less current liabilities.
See the Company’s consolidated financial statements in its Annual
Report on Form 10-K for the year ended December 31, 2021, to be
filed February 28, 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 the fourth quarter and full year 2021 financial results and
provide a corporate update today at 4:30 p.m. ET. To access the
live conference call, please dial (833) 301-1150 (domestic) or
(914) 987-7391 (international) at least five minutes prior to the
start time and refer to conference ID 7171208.
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
life-threatening viral diseases. Leveraging the Company’s deep
understanding of antiviral drug development, nucleos(t)ide
chemistry, biology, biochemistry and virology, Atea has built a
proprietary nucleotide 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 out 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 combination product candidates and AT-752, 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
following: uncertainty around and costs associated with the
development of AT-752 as a potential treatment for dengue and
combination product candidates including bemnifosbuvir for the
potential treatment for COVID-19 and HCV; dependence on management,
directors and other key personnel; the impact of the COVID-19
pandemic on our business; our limited operating history and no
history of successfully developing or commercializing any products,
significant operating expenses since inception; our need for
substantial additional funding; our ability to use our net
operating loss carryforwards; our dependence on the success of our
most advanced product candidates; risks related to the regulatory
approval process; risks associated with the clinical development
process and reliance on interim, topline or preliminary clinical
trial results; risks related to healthcare laws and other legal
compliance matters; risks related to potential commercialization;
risks related to manufacturing and our dependence on third parties;
risks relating to intellectual property; our ability to maintain
effective internal control over financial reporting and the
significant costs as a result of operating as a public company.
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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