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 second quarter
ended June 30, 2023 and provided a business update.
“We continue to advance the global Phase 3 SUNRISE-3 trial for
COVID-19 with an expanded global footprint and protocol
modifications designed to broaden the eligibility criteria for
high-risk patients and increase the study sample size to reflect
the current global hospitalization and death rates. Importantly, we
do not anticipate that these modifications will change the timing
for this trial, as we continue to expect topline results in
mid-2024 and are currently targeting a New Drug Application
submission by year-end 2024,” said Jean-Pierre Sommadossi, PhD,
Chief Executive Officer and Founder of Atea Pharmaceuticals. “Our
strategy for COVID-19 is focused on delivering an effective
treatment to the millions of patients for whom the current standard
of care is not a suitable option.”
“We have also advanced and are pleased with the progress of our
Phase 2 combination study of bemnifosbuvir and ruzasvir for the
treatment of HCV. During the second quarter of 2023, we began
dosing HCV patients, and we look forward to reporting initial
results from our lead-in cohort of approximately 60 patients by
year-end 2023,” continued Dr. Sommadossi. “Our goal for this
program 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
SUNRISE-3 Trial Protocol Amendment:
Modifications of the SUNRISE-3 protocol are designed to broaden the
high-risk patient population eligible for enrollment in the trial
and to increase the study sample size to account for the lower
rates of hospitalization and death that are being observed globally
for COVID-19 in 2023 versus 2022.
With the amendment, the patient population will be expanded to
include patients ≥70 years old (regardless of other risk factors),
patients ≥55 years old with one or more risk factors, patients ≥50
years old with two or more risk factors and patients ≥18 years old
with certain risk factors including immunocompromised conditions,
all regardless of COVID-19 vaccination status. Also, patients with
decreased renal function will be eligible for the trial.
Additionally, considering the currently observed low rates of
hospitalization and death, the amendment modifies the trial from an
adaptive design to a static design targeting enrollment of a fixed
number of approximately 2,200 patients in the supportive care
(monotherapy) arm compared with the original protocol which
targeted approximately 1,300 patients in the same arm but allowed
for a potential sample size re-estimation and increase following an
interim analysis. The amendment also incorporates two interim
analyses for review by the data and safety monitoring board
principally for safety and futility after approximately 650 and
1,350 evaluable patients, respectively, in the supportive care
(monotherapy) arm have completed Day 29.
Bemnifosbuvir SUNRISE-3 Trial in High-Risk Outpatients
with COVID-19: Patient enrollment continues in the
global, multicenter, randomized, double-blind, placebo-controlled,
registrational Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, a
nucleotide polymerase inhibitor, or placebo administered
concurrently with locally available standard of care (SOC).
SUNRISE-3 has a global footprint with a target of approximately 330
clinical sites in approximately 30 countries and is designed to
enroll 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 either
bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five
days.
The trial consists of two study populations derived from the
type of SOC received: 1) “supportive care population” (those
patients who do not qualify for an approved antiviral treatment or
where antivirals are not locally available), which will assess
bemnifosbuvir given as monotherapy (primary analysis) and 2)
“combination antiviral population”, which will assess combination
therapy if the SOC includes treatment with other compatible
antiviral drugs against COVID-19 (secondary analysis).
The primary endpoint of the SUNRISE-3 study is all-cause
hospitalization or death through Day 29 in the supportive care
(monotherapy) arm and is powered to detect a clinically meaningful
reduction in hospitalization or death versus placebo in this
population.
Granted Fast Track Designation by U.S.
FDA: In April 2023, Atea announced that the U.S. Food
and Drug Administration (FDA) granted Fast Track designation to
investigate 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.
Presentation of Data Showing Bemnifosbuvir Reduced Risk
of Hospitalizations for COVID-19 Patients at 2023 European Congress
of Clinical Microbiology & Infectious Diseases (ECCMID
2023): In April 2023, 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.
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: In June 2023,
Atea initiated enrollment of a Phase 2 clinical trial of
bemnifosbuvir in combination with ruzasvir in treatment-naïve,
HCV-infected patients either without cirrhosis or with compensated
cirrhosis. This study is designed to evaluate the safety and
efficacy of eight weeks of treatment with the pan-genotypic
combination consisting of once-daily bemnifosbuvir 550 mg and
ruzasvir 180 mg. Approximately 280 HCV-infected, treatment-naïve
patients across all genotypes, including a lead-in cohort of
approximately 60 patients are expected to be enrolled in this Phase
2 clinical trial. 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 are anticipated in the fourth quarter of 2023.
The combination of bemnifosbuvir and ruzasvir has the potential
to significantly improve upon the current standard of care by
offering a differentiated short duration, pan-genotypic
protease-inhibitor free regimen for HCV-infected patients with or
without cirrhosis.
Second Quarter 2023 Financial Results
Cash, Cash Equivalents and Marketable
Securities: $608.1 million at June 30, 2023 compared
to $646.7 million at December 31, 2022.
Research and Development
Expenses: Research and development expenses for the
quarter ended June 30, 2023 in the amount of $22.1 million
increased by $2.2 million from $19.9 million for the
quarter ended June 30, 2022. The increase was primarily the result
of higher expenses in connection with the SUNRISE-3 clinical trial
for COVID-19 and Phase 2 clinical trial for HCV.
General and Administrative
Expenses: General and administrative expenses
remained relatively consistent at $13.2 million for the quarter
ended June 30, 2023 compared to $12.4 million for the quarter
ended June 30, 2022.
Interest Income and Other, Net: Interest
income and other, net was $7.3 million for the quarter ended June
30, 2023 compared to $1.1 million for the quarter ended June 30,
2022. The increase was primarily the result of investing in higher
yield marketable securities and higher interest rates.
Income Tax Expense: Income tax expense
remained relatively consistent at $0.3 million for the quarter
ended June 30, 2023 compared to $0.1 million for the quarter
ended June 30, 2022.
Condensed Consolidated Statement of
Operations and Comprehensive Income (Loss)(in thousands,
except share and per share amounts)(unaudited)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
22,063 |
|
|
$ |
19,858 |
|
|
$ |
51,017 |
|
|
$ |
49,491 |
|
General and administrative |
|
13,172 |
|
|
|
12,437 |
|
|
|
25,787 |
|
|
|
24,979 |
|
Total operating expenses |
|
35,235 |
|
|
|
32,295 |
|
|
|
76,804 |
|
|
|
74,470 |
|
Income (loss) from
operations |
|
(35,235 |
) |
|
|
(32,295 |
) |
|
|
(76,804 |
) |
|
|
(74,470 |
) |
Interest income and other,
net |
|
7,303 |
|
|
|
1,080 |
|
|
|
13,602 |
|
|
|
1,178 |
|
Income (loss) before income
taxes |
|
(27,932 |
) |
|
|
(31,215 |
) |
|
|
(63,202 |
) |
|
|
(73,292 |
) |
Income tax expense |
|
(251 |
) |
|
|
(120 |
) |
|
|
(448 |
) |
|
|
(120 |
) |
Net loss |
$ |
(28,183 |
) |
|
$ |
(31,335 |
) |
|
$ |
(63,650 |
) |
|
$ |
(73,412 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on available-for- sale investments |
|
(3 |
) |
|
|
--- |
|
|
|
374 |
|
|
|
--- |
|
Comprehensive loss |
$ |
(28,186 |
) |
|
$ |
(31,335 |
) |
|
$ |
(63,276 |
) |
|
$ |
(73,412 |
) |
Net loss per share – basic and
diluted |
$ |
(0.34 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.76 |
) |
|
$ |
(0.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
used in computing net loss per share – basic and diluted |
|
83,399,377 |
|
|
|
83,257,591 |
|
|
|
83,361,398 |
|
|
|
83,217,223 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Condensed Consolidated Balance
Sheet Data (in thousands)(unaudited)
|
June 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and marketable securities |
$ |
608,062 |
|
|
$ |
646,709 |
|
Working capital(1) |
|
604,667 |
|
|
|
642,444 |
|
Total assets |
|
626,028 |
|
|
|
666,708 |
|
Total liabilities |
|
23,679 |
|
|
|
26,136 |
|
Total stockholders'
equity |
|
602,349 |
|
|
|
640,572 |
|
|
|
|
|
|
|
|
|
(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 June 30, 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 second 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
webcast will be available on the Atea website approximately two
hours after the event.
About Bemnifosbuvir for COVID-19
Bemnifosbuvir, a nucleotide polymerase inhibitor, targets the
SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene that is
unlikely to change as the virus mutates and new variants continue
to emerge. This gene is responsible for both replication and
transcription of SARS-CoV-2. Bemnifosbuvir has a unique mechanism
of action, with dual targets consisting of chain termination (RdRp)
and nucleotityltransferase (NiRAN) inhibition, which has the
potential to create a high barrier to resistance. In
vitro data confirmed that bemnifosbuvir is active with similar
efficacy against all variants of concern and variants of interest
that have been tested, including Omicron subvariants BA.4, BA.5 and
XBB.
About Bemnifosbuvir and Ruzasvir for Hepatitis
C Virus (HCV)
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. The pharmacokinetic (PK)
profile of bemnifosbuvir supports once-daily dosing for the
treatment of HCV and bemnifosbuvir has been well-tolerated at doses
up to 550 mg for durations up to 8-12 weeks in healthy and
HCV-infected subjects.
Ruzasvir (RZR), an oral NS5A inhibitor, has demonstrated highly
potent and pangenotypic antiviral activity in preclinical
(picomolar range) and clinical studies. RZR has been administered
to over 1,200 HCV-infected patients at daily doses of up to 180 mg
for up to 24 weeks and has demonstrated a favorable safety profile.
RZR’s PK profile supports once-daily dosing.
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 Apr 2024 to May 2024
Atea Pharmaceuticals (NASDAQ:AVIR)
Historical Stock Chart
From May 2023 to May 2024