Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company engaged in the discovery
and development of oral antiviral therapeutics for serious viral
diseases, today reported financial results for the first quarter
ended March 31, 2023 and provided a business update.
“Highlights of the first quarter of 2023 include advancement of
our clinical trials and R&D efforts, together with multiple
data presentations at several scientific meetings in support of
bemnifosbuvir’s favorable safety and drug interaction profile and
its potential to address the key limitations of current therapies
faced by patients with COVID-19 and HCV,” said Jean-Pierre
Sommadossi, PhD, Chief Executive Officer and Founder of Atea
Pharmaceuticals. “The continued execution of the global
geographical footprint of our Phase 3 SUNRISE-3 trial for COVID-19
and the recent U.S. Food and Drug Administration Fast Track
designation granted to bemnifosbuvir, bring us closer to our goal
of delivering an effective treatment to the millions of COVID-19
patients for whom the current standard of care is not a suitable
option.”
“The initiation of our Phase 2 combination study of
bemnifosbuvir and ruzasvir is an important milestone, and we look
forward to initial results from our lead-in cohort of approximately
60 patients by year-end,” continued Dr. Sommadossi. “Nearly 300,000
people continue to die every year from HCV-related liver diseases,
according to the World Health Organization. Our goal, supported by
in vitro and clinical data generated to-date, is to significantly
improve upon the current standard of care by offering a short
duration, pan-genotypic, protease inhibitor-free treatment for
patients with HCV, with or without cirrhosis.”
Bemnifosbuvir for COVID-19 Update
Granted Fast Track Designation by U.S. FDA: In
April, Atea announced that the U.S. Food and Drug Administration
(FDA) granted Fast Track designation to bemnifosbuvir for the
treatment of COVID-19. The FDA’s Fast Track program is designed to
facilitate the expedited development and review of new drugs or
biologics that are intended to treat serious or life-threatening
conditions and demonstrate the potential to address unmet medical
needs. Among other things, as a result of the Fast Track
designation, Atea may benefit from more frequent communications
with the FDA to discuss the development plan of bemnifosbuvir for
the treatment of COVID-19 and rolling review of any completed
sections of any resulting New Drug Application.
Bemnifosbuvir SUNRISE-3 trial in High-Risk Outpatients
with COVID-19: Patient enrollment continues in the
global, randomized, double-blind, placebo-controlled,
registrational Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, a
nucleotide polymerase inhibitor, administered concurrently with
locally available standard of care. The study is designed to enroll
at least 1,500 high-risk outpatients with mild or moderate COVID-19
at clinical trial sites worldwide, including in the U.S., Europe,
and Japan. Patients are being randomized 1:1 to receive locally
available standard of care and either bemnifosbuvir 550 mg
twice-daily (BID) or placebo BID for five days. The primary
endpoint of the study is all-cause hospitalization or death through
Day 29 in the supportive care population comprised of at least
1,300 patients.
Presentation of Bemnifosbuvir Data Showing Reduced
Hospitalizations for COVID-19 Patients at 2023 European Congress of
Clinical Microbiology & Infectious Diseases (ECCMID
2023): In April, Atea presented the full results from the
MORNINGSKY trial, which evaluated bemnifosbuvir for the treatment
of mild to moderate COVID-19. As previously announced, these
results showed that non-hospitalized adult and adolescent patients
who received bemnifosbuvir experienced a 71% relative reduction in
risk of hospitalization, regardless of vaccination status
(secondary endpoint). In an exploratory analysis, an 82% reduction
in risk of hospitalization was seen in a subset of patients greater
than 40 years of age. Based on these data, the global Phase 3
SUNRISE-3 registrational trial was initiated.
Favorable Drug Interaction Profile of Bemnifosbuvir
Presented at 36th International Conference on
Antiviral Research (ICAR 2023): In March, Atea presented
Phase 1, in vitro and preclinical data that demonstrated key
profile attributes of bemnifosbuvir. The data presented included
results from a Phase 1 human absorption, distribution, metabolism,
and excretion (ADME) study for bemnifosbuvir demonstrating a
favorable ADME profile supportive of the dosing regimen being
evaluated in SUNRISE-3. In vitro metabolism and transporter
interaction studies showed bemnifosbuvir has a low risk for
interactions with medicines commonly taken by COVID-19 high risk
patients for other conditions. In vitro studies also demonstrated
advantages of bemnifosbuvir’s mechanism of action, which targets
conserved regions of the virus that causes COVID-19. These
potential advantages include a high barrier to resistance and
maintenance of antiviral activity in the presence of COVID-19
variants.
Favorable Profile of Bemnifosbuvir Related to Low Risk
for Drug-Drug Interactions Presented at Conference on Retroviruses
and Opportunistic Infections (CROI 2023):
In February, Atea presented data from three Phase 1 studies that
showed the favorable drug-drug interaction profile of
bemnifosbuvir. The results of these studies, including a study with
midazolam, indicate that no dosage adjustment of CYP3A substrates
or of drugs that are sensitive substrates of efflux and hepatic
uptake transporters is likely to be needed when co-administrated
with bemnifosbuvir. CYP3A is an enzyme that metabolizes many
classes of medicines and medicinal supplements, and efflux/hepatic
uptake transporters regulate cellular trafficking of many medicines
that are commonly prescribed to COVID-19 high risk patients.
Bemnifosbuvir Retains Antiviral Activity Against Omicron
Subvariant XBB 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
subvariant XBB. 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, BA.2, BA.4, and BA.5.
COVID-19 Program for Second Generation Protease
Inhibitors: As part of a multipronged approach
against COVID-19, Atea is engaged in efforts directed to the
discovery of second-generation protease inhibitors that have
clinical profiles well suited for combination with bemnifosbuvir
for the treatment of COVID-19. These efforts are supported by in
vitro studies which have demonstrated that the combination of
bemnifosbuvir and nirmatrelvir have an additive antiviral effect
and the expectation that certain patient populations will require
combination therapy. Activities to select a novel proprietary
compound are underway.
Hepatitis C Virus (HCV) Program Update
Phase 2 HCV Combination Study: Atea is on track
to initiate patient dosing in the second quarter of 2023 in the
Phase 2 combination study of bemnifosbuvir and ruzasvir, an oral
NS5A inhibitor.
This open label Phase 2 study is expected to enroll
approximately 280 HCV-infected, direct-acting antiviral naive
patients across all genotypes, including a 60 patient lead-in
cohort. Patients will be administered 550 mg bemnifosbuvir in
combination with 180 mg ruzasvir 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. Initial data from the 60-patient lead-in cohort is
anticipated in the fourth quarter of 2023.
Synergistic Antiviral Effect Observed for the
Combination of Bemnifosbuvir + Ruzasvir Against HCV
In Vitro Presented at
36th International Conference on Antiviral Research (ICAR
2023): In March, Atea presented in vitro data
demonstrating that the combination of bemnifosbuvir and ruzasvir
had greater inhibition of HCV replication than the sum of both
compounds alone, suggesting a synergistic antiviral effect when
bemnifosbuvir and ruzasvir were administered together.
In vivo results from a 13-week toxicity study in rats also
demonstrated that systemic exposures of bemnifosbuvir, its
metabolites, and ruzasvir were similar when administered
independently or in combination, suggesting no significant
drug-drug interactions between bemnifosbuvir and ruzasvir.
This synergistic activity and no significant drug-drug
interactions, together with the previously demonstrated potent,
pan-genotypic, antiviral activity of each agent alone, support the
initiation of the Phase 2 combination of bemnifosbuvir and
ruzasvir, which has the potential to offer a differentiated, short
duration, pan-genotypic, protease inhibitor-sparing regimen for
patients with HCV, with or without cirrhosis.
New In Vitro
Bemnifosbuvir and Ruzasvir Data: New data from an
in vitro study demonstrated that bemnifosbuvir is at least 10 times
more potent than sofosbuvir and retains full potency against
all HCV GT-1a and GT-3a NS5A resistance associated variants (RAVs)
tested. In addition, new data show that ruzasvir is more potent
than velpatasvir and retains a favorable potency profile against a
panel of HCV GT-1a and GT-3a NS5A RAVs. Based on these in vitro
data combined with other data to-date, it is expected that the
combination of bemnifosbuvir and ruzasvir will retain antiviral
activity against major clinically relevant HCV NS5A RAVs.
Dengue Program Update
Data presented at ECCMID 2023, and recently published in the
peer-reviewed journal, Antiviral Research, together with data
to-date, indicate a favorable biological, pharmacological and
safety profile for AT-752. However, due to the anticipated long
clinical timelines and major associated costs, Atea deprioritized
its dengue program and the development of AT-752 in February 2023
and made the business decision to focus on its COVID-19 and HCV
programs.
First Quarter 2023 Financial Results
Cash, Cash Equivalents and Marketable
Securities: $620.5 million at March 31, 2023 compared to
$646.7 million at December 31, 2022.
Research and Development Expenses: Research and
development expenses remained relatively consistent at $29.0
million for the quarter ended March 31, 2023 compared to $29.6
million for the quarter ended March 31, 2022.
General and Administrative Expenses: General
and administrative expenses remained relatively consistent at $12.6
million for the quarter ended March 31, 2023 compared to $12.5
million for the quarter ended March 31, 2022.
Interest Income and Other, Net: Interest income
and other, net was $6.3 million for the quarter ended March 31,
2023 compared to $0.1 million for the quarter ended March 31, 2022.
The increase was primarily the result of investing in higher yield
marketable securities and higher interest rates.
Income Taxes: Income tax expense was $0.2
million for the quarter ended March 31, 2023. Atea did not record
income tax expense for the quarter ended March 31, 2022.
Condensed Consolidated Statement of Operations and
Comprehensive Loss(in thousands, except share and per
share amounts)(unaudited) |
|
Three Months EndedMarch 31, |
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
Research and
development |
$ |
28,954 |
|
$ |
29,633 |
|
General and
administrative |
|
12,615 |
|
|
12,542 |
|
Total operating
expenses |
|
41,569 |
|
|
42,175 |
|
Loss from
operations |
|
(41,569 |
) |
|
(42,175 |
) |
Interest income and other,
net |
|
6,299 |
|
|
98 |
|
Loss before income
taxes |
|
(35,270 |
) |
|
(42,077 |
) |
Income tax
expense |
|
(197 |
) |
|
— |
|
Net
loss |
$ |
(35,467 |
) |
$ |
(42,077 |
) |
Other comprehensive
income: |
|
|
Unrealized gains on available-for-sale
|
|
377 |
|
|
Comprehensive
loss |
$ |
(35,090 |
) |
$ |
(42,077 |
) |
Net loss per share – basic and
diluted |
$ |
(0.43 |
) |
$ |
(0.51 |
) |
Weighted-average common shares
used in computing net loss per share – basic and
diluted |
|
83,332,397 |
|
|
83,176,408 |
|
Selected Condensed Consolidated Balance Sheet Data
(in thousands) |
|
March 31, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
Cash, cash equivalents, and marketable
securities |
$ |
620,488 |
|
$ |
646,709 |
Working capital(1) |
|
620,029 |
|
|
642,444 |
Total assets |
|
638,131 |
|
|
666,708 |
Total liabilities |
|
19,949 |
|
|
26,136 |
Total stockholders' equity |
|
618,182 |
|
|
640,572 |
(1) Atea 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, 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 first quarter 2023 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. To participate via telephone, please
register in advance here. Upon registration, all telephone
participants will receive a confirmation email detailing how to
join the conference call, including the dial-in number along with a
unique passcode and registrant ID that can be used to access the
call. While not required, it is recommended that participants join
the call ten minutes prior to the scheduled start. An archived copy
of the audio webcast will be available on the Atea website
approximately two hours after the event.
About Atea Pharmaceuticals
Atea is a clinical stage biopharmaceutical company focused on
discovering, developing and commercializing oral antiviral
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 for the treatment of COVID-19,
any new protease inhibitor we may advance for clinical development
in combination with bemnifosbuvir for the treatment of COVID-19 and
the combination of bemnifosbuvir and ruzasvir for the treatment of
HCV. 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. 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
Atea Pharmaceuticals (NASDAQ:AVIR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Atea Pharmaceuticals (NASDAQ:AVIR)
Historical Stock Chart
From Apr 2023 to Apr 2024