Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today reported financial
results for the third quarter ended September 30, 2022 and provided
a business update.
“This year, we have made substantial progress advancing our
three clinical candidates, which will make 2023 a pivotal year. We
expect imminent enrollment of patients into SUNRISE-3 evaluating
bemnifosbuvir for COVID-19. Around the end of the year, we
anticipate completing enrollment in the AT-752 challenge study and
the first cohort of DEFEND-2 with initial data to follow and
submitting clinical trial applications for the bemnifosbuvir and
ruzasvir combination hepatitis C study, leading to Phase 2
initiation,” said Jean-Pierre Sommadossi, PhD, Chief Executive
Officer and Founder of Atea Pharmaceuticals. “In addition, as part
of our strategy for COVID-19, we continue to progress our
second-generation protease inhibitor discovery program, focused on
candidates with profiles that are well suited for combination
therapy with bemnifosbuvir and expect to soon identify a candidate
to advance toward the clinic.”
“The rapid increase of multiple new variants in different
regions coupled with the waning durability of immunity associated
with vaccines and natural infections has led to predictions of
further COVID-19 waves, which should enable an opportunity for
patient enrollment in our SUNRISE-3 trial,” continued Dr.
Sommadossi. “In addition to relapse and safety concerns associated
with current oral antivirals for COVID-19, the critical issue of
drug-drug interactions with commonly prescribed life-saving drugs
has led to a major unmet need among patients at high risk for
severe disease including the elderly, those with COVID-19 risk
factors and immunocompromised patients. Furthermore, monoclonal
antibodies are largely ineffective against the newer COVID-19
variants leaving many without treatment options. There remains an
urgent need for new COVID-19 oral therapeutics with a profile such
as bemnifosbuvir, which has the potential to address the key
limitations of current oral antivirals and is effective across all
variants.”
Bemnifosbuvir (AT-527) Program Update for
COVID-19
SUNRISE-3: Global Phase 3 Registrational Study of
Bemnifosbuvir in High-Risk Non-Hospitalized Patients with
COVID-19: Before year-end 2022, Atea expects to begin
enrollment of a randomized, double-blind, placebo-controlled,
global Phase 3 study 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, with a
global footprint of approximately 300 clinical trial sites in the
United States, Europe, Japan and rest of the world. Patients will
be 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.
This trial will be comprised of two populations derived from the
type of SOC received. These are 1) “Supportive care population”
(the patient does not qualify for an authorized oral antiviral
treatment or is in a region where oral antivirals are not locally
available) which will assess bemnifosbuvir given as monotherapy
(primary analysis) and 2) “Combination antiviral population” which
will assess combination therapy being bemnifosbuvir plus SOC if the
SOC includes treatment with other compatible 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 each patient
population include: COVID-19 complications, medically attended
visits, symptom rebound / relapse and viral load rebound.
The patient population will consist of those at the highest risk
for disease progression, including 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.
Bemnifosbuvir Retains Antiviral Activity Against Omicron
Subvariants BA.4 and BA.5 In
Vitro: AT-511, the free base of
bemnifosbuvir, has been shown to be a potent inhibitor of
SARS-CoV-2 in vitro. New results demonstrated that AT-511
retained potent antiviral activity against the SARS-CoV-2 Omicron
subvariants BA.4 and BA.5. AT-511 has previously
demonstrated in vitro potent antiviral activity against
other variants of concern and/or of interest, including Alpha,
Beta, Gamma, Epsilon, Delta and Omicron subvariants BA.1 and
BA.2.
Advancing Multipronged Approach for COVID-19 for Future
Preparedness
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 appropriate for combination with bemnifosbuvir
for the treatment of COVID-19. 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 booster (e.g., ritonavir). The lead optimization of
compounds is ongoing for selection of a candidate that will next
enter preclinical toxicology studies.
The combination of bemnifosbuvir with the protease inhibitor
nirmatrelvir was examined in vitro in an HCoV-229E surrogate model
and results indicated an additive antiviral effect. These data
support the potential benefit of the combination of bemnifosbuvir
and a protease inhibitor for the treatment of SARS-CoV-2
infection.
AT-752 Program Update for DengueGlobal
Phase 2 Dengue Study and Human Challenge Trial: Patient
enrollment continues in the global Phase 2 DEFEND-2
(DEngue Fever
END) trial of AT-752 for the treatment of dengue.
The randomized, double-blind, placebo-controlled trial is designed
to evaluate multiple doses of AT-752 in three distinct cohorts
(n=20 per cohort) and may enroll up to 60 adult patients infected
with dengue. The primary objective of the trial is to assess
antiviral activity, with change from baseline 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 trial, Atea is enrolling 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.
Patient enrollment in the human challenge trial and the first
cohort of the DEFEND-2 study is expected to be completed around
year-end 2022 with initial data to follow.
AT-752 Favorable Phase 1 Data Presented at American
Society of Tropical Medicine & Hygiene 2022 Annual
Meeting: Atea presented data from its Phase 1 study that
demonstrated AT-752 rapidly achieved plasma levels exceeding the in
vitro EC90 and was generally safe and well tolerated up to the
highest does tested. No premature discontinuations due to adverse
events or serious adverse events were reported, most adverse events
in the study were mild and there were no clinically relevant
changes in laboratory parameters. Additionally, the study results
demonstrated that AT-752 may be taken with or without food and
there was no pharmacokinetic sensitivity among varying ethnic
populations. The results from this study and in vitro data
demonstrating pan-serotypic activity supported the advancement of
AT-752 into the DEFEND-2 trial and the human challenge study.
Hepatitis C Virus (HCV) Program Update
Phase 2 HCV Combination Program: Atea expects
to submit clinical trial applications for the Phase 2 combination
study of bemnifosbuvir and ruzasvir (RZR) around the end of the
year with initiation of the Phase 2 trial to follow. Studies
conducted by Atea have shown in vitro synergy from the combination
of bemnifosbuvir and RZR in inhibiting HCV replication.
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.
Third Quarter 2022 Financial Results
Cash, Cash Equivalents and Marketable
Securities: $665.0 million at September 30, 2022
compared to $764.4 million at December 31, 2021.
Research and Development Expenses:
Research and development expenses decreased by $38.1 million from
$43.0 million for the three months ended September 30, 2021 to
$4.9 million for the three months ended September 30, 2022.
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 and includes a credit in the
amount of $14.5 million related to the close out by Roche of
certain clinical trial activities that were previously the subject
of the cost sharing arrangement. Research and development expenses
recorded for the Roche cost share agreement for the three months
ended September 30, 2021 were $25.3 million compared to a credit of
$14.5 million recorded for the three months ended September 30,
2022. Partially offsetting the decrease in research and development
expenses was an increase of $1.7 million related to salaries and
bonuses, benefits and stock-based compensation expense for our
research and development employees and consulting fees and other
research and development expenses.
General and Administrative Expenses: General
and administrative expenses remained relatively consistent at
approximately $11.9 million for the three months ended
September 30, 2021 and $11.4 million for the three months
ended September 30, 2022.
Interest Income and Other, Net: Interest income
and other, net, increased by $4.4 million from less than $0.1
million for the three months ended September 30, 2021 to $4.4
million during the three months ended September 30, 2022. The
increase was primarily a result of investing in higher yield
marketable securities and higher interest rates.
Income Tax Expense: A net benefit for income
taxes of $3.8 million was recorded for the three months ended
September 30, 2022 compared to a provision for income taxes of $6.1
million for the three months ended September 30, 2021. The net
benefit 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, the
Company had a tax liability and recorded income tax expense
associated with amounts received from our former collaboration with
Roche.
|
Condensed Consolidated Statement of Operations(in
thousands, except share and per share amounts)(unaudited) |
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Collaboration revenue |
$ |
— |
|
|
$ |
32,811 |
|
|
$ |
— |
|
|
$ |
159,187 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
4,905 |
|
|
|
43,019 |
|
|
|
54,396 |
|
|
|
109,394 |
|
General and administrative |
|
11,376 |
|
|
|
11,939 |
|
|
|
36,355 |
|
|
|
32,597 |
|
Total operating expenses |
|
16,281 |
|
|
|
54,958 |
|
|
|
90,751 |
|
|
|
141,991 |
|
Income (loss) from
operations |
|
(16,281 |
) |
|
|
(22,147 |
) |
|
|
(90,751 |
) |
|
|
17,196 |
|
Interest income and other,
net |
|
4,382 |
|
|
|
53 |
|
|
|
5,560 |
|
|
|
162 |
|
Income (loss) before income
taxes |
|
(11,899 |
) |
|
|
(22,094 |
) |
|
|
(85,191 |
) |
|
|
17,358 |
|
Income tax benefit (expense) |
|
3,833 |
|
|
|
(6,100 |
) |
|
|
3,713 |
|
|
|
(13,300 |
) |
Net income (loss) |
$ |
(8,066 |
) |
|
$ |
(28,194 |
) |
|
$ |
(81,478 |
) |
|
|
4,058 |
|
Net income (loss) per share
attributable to common stockholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.10 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.98 |
) |
|
$ |
0.05 |
|
Diluted |
$ |
(0.10 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.98 |
) |
|
$ |
0.05 |
|
Weighted-average common shares
outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
83,258,537 |
|
|
|
82,815,636 |
|
|
|
83,231,146 |
|
|
|
82,727,268 |
|
Diluted |
|
83,258,537 |
|
|
|
82,815,636 |
|
|
|
83,231,146 |
|
|
|
88,462,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Condensed Consolidated Balance Sheet
Data(in thousands) |
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
(unaudited) |
|
|
Cash, cash equivalents, and marketable securities |
$ |
664,975 |
|
|
$ |
764,375 |
|
Working capital (1) |
|
666,301 |
|
|
|
715,520 |
|
Total assets |
|
686,576 |
|
|
|
772,892 |
|
Total liabilities |
|
23,389 |
|
|
|
62,815 |
|
Total stockholders'
equity |
|
663,187 |
|
|
|
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 September 30, 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 third quarter 2022 financial results and provide a
corporate 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.
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 HCV and clinical development of AT-752 for dengue. 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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