Aankondiging • Nov 13

Atea Pharmaceuticals, Inc. Announces Research Findings, Including Evidence of A Unique Dual Mechanism of Action for Bemnifosbuvir Against Hepatitis C Virus and the Expansion of the Company's Antiviral Pipeline with A New Hepatitis E Virus Program

Atea Pharmaceuticals, Inc. announced new research findings, including evidence of a unique dual mechanism of action for bemnifosbuvir against hepatitis C virus (HCV) and the expansion of the Company's antiviral pipeline with a new hepatitis E virus (HEV) program, and provided a business update. The Company’s combination regimen of bemnifosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of HCV is currently being evaluated in a global Phase 3 development program. This program is comprised of two Phase 3 clinical trials with C-BEYOND being conducted in the US and Canada and C-FORWARD being conducted outside North America. Patient enrollment is on track in both trials. The Company currently anticipates that C-BEYOND will be fully enrolled by the end of 2025 with topline results available mid-2026. Additionally, the Company expects patient enrollment in C-FORWARD to be completed mid-2026 with topline results available around the end of 2026.During the past week, presentations made at The Liver Meeting 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) reported new data 1) supporting the antiviral potency of the bemnifosbuvir and ruzasvir regimen, 2) highlighting the regimen’s high barrier to resistance, and 3) demonstrating the high relative bioavailability of the bemnifosbuvir and ruzasvir fixed dose combination (FDC) commercial formulation. These data also support dosing of the FDC with or without food or with famotidine, an H2 blocker which can substantially diminish the effectiveness of HCV oral antivirals. The FDC commercial formulation is being used in the ongoing Phase 3 program. The Liver Meeting took place November 7-11 in Washington, DC. The Company also announced the expansion of its antiviral pipeline with a new HEV program, which includes two proprietary lead candidates with potent nanomolar antiviral activity against HEV in vitro. New Data Show Unique Dual Mechanism of Action (MoA) for Bemnifosbuvir Against HCVBemnifosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, has an established MoA of inhibition of HCV RNA leading to chain termination, blocking viral production and replication inside the host cell. However, new modeling of HCV viral kinetics from a Phase 1 monotherapy trial suggests that bemnifosbuvir may also inhibit the assembly/secretion of new HCV virions into the bloodstream, significantly reducing extracellular HCV RNA. This additional MoA of bemnifosbuvir is a mechanism previously only associated with NS5A inhibitors, such as ruzasvir and velpatasvir. New in vitroresults confirm the dual MoA of bemnifosbuvir. These new results, demonstrating the dual MoA of bemnifosbuvir, highlight the unique and differentiated profile of bemnifosbuvir and further explain the potency of the combination regimen of bemnifosbuvir and ruzasvir for the treatment of HCV. Highlights from the three presentations included: A resistance analysis from a Phase 2 study of the combination of bemnifosbuvir and ruzasvir demonstrated that SVR12 rates were not impacted by resistance associated substitutions (RASs). These data support the regimen’s high barrier to resistance in patients infected with HCV. Viral kinetics and pharmacokinetic analyses indicated that most of the viral failures were due to treatment non-adherence. Results from a Phase 1 study in healthy participants demonstrated the high relative bioavailability of the bemnifosbuvir and ruzasvir FDC commercial formulation. These results also support dosing of the FDC with or without food or with famotidine, an H2 blocker which can substantially diminish the effectiveness of HCV oral antivirals. Multiscale modeling predicted that the combination regimen of bemnifosbuvir and ruzasvir inhibits both intracellular replication of HCV, as well as viral assembly and secretion of new HCV virions into the bloodstream in patients with chronic HCV infection, with a modeled time to cure of approximately 7 to 8 weeks. Because the regimen suppresses the virus at multiple critical stages, the data support the potential of the combination regimen as a simplified, short-duration therapy for chronic HCV. New Development Program for HEVThe Company is advancing two novel, proprietary development candidates, AT-587 and AT-2490, which have exhibited potent nanomolar antiviral activity in vitro against HEV genotypes GT-1 and GT-3. Investigational new drug (IND) enabling studies of AT-587 and AT-2490 are ongoing to select the clinical candidate for a Phase 1 program, which is anticipated to begin in mid-2026.Chronic HEV GT-3 and GT-4 infections occur most frequently in immunocompromised individuals with the potential of rapid progression to cirrhosis, particularly in at-risk populations including solid organ transplant recipients and patients with hematological malignancies, a history of haematopoietic stem cell transplant (HSCT) and pre-existing liver disease. There are currently no approved antiviral therapies for this unmet medical need. Current interventions include a reduction of immunosuppressives and treatment with ribavirin, an antiviral associated with safety concerns and limited efficacy for HEV. Each of these options pose substantial challenges for immunocompromised patient populations infected with HEV.Phase 3 C-BEYOND and C-FORWARD Trials in Adults with Chronic HCVThe Company’s HCV global Phase 3 development program includes two open-label Phase 3 trials, C-BEYOND being conducted in the US and Canada, and C-FORWARD being conducted outside of North America. Each Phase 3 trial is enrolling approximately 880 treatment-naïve patients, including those with or without compensated cirrhosis. The trials compare the bemnifosbuvir and ruzasvir FDC commercial formulation to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks to all patients, with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA Physician Perspectives – Key Market Research Finding A survey of healthcare providers who treat HCV patients revealed they are seeking a new treatment option offering high efficacy, a short treatment duration and a low risk of drug-drug interactions to address the needs of the current HCV patient population as up to 80% of patients take multiple medications to manage comorbidities and coinfections. The healthcare providers surveyed are among the 153 top prescribers of direct acting antivirals (DAA) in the US, including 86 gastroenterologist/hepatologists, 34 infectious disease specialists and 33 internal medicine specialists. IQVIA conducted the survey as part of independent quantitative market research commissioned by the Company.

Aankondiging • Jan 09

Atea Pharmaceuticals, Inc. Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment for Phase 3 SUNRISE-3 Trial for COVID-19

Atea Pharmaceuticals, Inc. announced the achievement of two significant clinical milestones from its Hepatitis C Virus (HCV) and COVID-19 programs. The Company reported positive initial data from the first 52 patients in the lead-in cohort of its Phase 2 combination 8-week study of bemnifosbuvir and ruzasvir (RZR) for the treatment of HCV. Additionally, Atea has enrolled more than 650 patients in the monotherapy arm of its Phase 3 SUNRISE-3 trial for the treatment of COVID-19, and enrollment continues with the current wave. This enrollment milestone allows for the first interim analysis of the study by the DSMB, which is expected this March. The Phase 2 open label study of bemnifosbuvir and RZR enrolled a lead-in cohort of 60 direct acting antiviral naïve, non-cirrhotic patients across all genotypes. Patients were administered 550 mg of bemnifosbuvir in combination with 180 mg of RZR once-daily for 8 weeks. Preliminary data are being presented as available, with SVR4 data currently available from 52 of the 60 lead-in patients. Including SVR4 as a decision endpoint, is a study design that is intended to substantially shorten the anticipated timeline for the completion of the Phase 2 trial. Clinical trials of other direct acting antiviral therapy combinations have demonstrated that the SVR4 result is highly correlated with SVR12.The initial results for the first 52 patients who reached this timepoint demonstrated a SVR4 rate of 98%, including one patient with poor adherence who did not achieve SVR4. Additionally, very rapid kinetics were observed in all 60 patients across genotypes with viral load near or below the lower limit of quantification (LLOQ) at 4 weeks of treatment, which is supportive of an 8-week treatment regimen for the combination of bemnifosbuvir and RZR. All 60 patients achieved viral load below the LLOQ at the end of the treatment. The combination was generally safe and well tolerated. There were no drug related serious adverse events, no treatment discontinuations and adverse events were mostly mild.The Phase 2 study aims to assess the safety and efficacy of 8 weeks of treatment with the combination of bemnifosbuvir and RZR in treatment-naïve HCV-infected patients, either without cirrhosis and or with compensated cirrhosis. The primary endpoint of the study is SVR12.Approximately 280 treatment-naïve HCV-infected patients, including the lead-in cohort, are expected to be enrolled in the Phase 2 study. The second part of the trial is anticipated to enroll 220 patients across all genotypes. An expanded geographic footprint to include approximately 50 clinical sites in approximately 15 countries is currently being activated. Full enrollment of the study is expected to be completed by mid-2024 with topline results in the third quarter of 2024. Phase 3 SUNRISE-3 Trial Enrollment Update: SUNRISE-3 is a global, multicenter, randomized, double-blind, placebo-controlled, registrational Phase 3 trial evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC). The study has a large global footprint targeting approximately 300 clinical trial sites in the U.S., Europe, Japan and rest of the world. Patients are randomized 1:1 to receive either bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days. SUNRISE-3 is the only Phase 3 program in high-risk COVID-19 patients with hospitalization as a primary endpoint.This trial is comprised of two study populations based on the type of SOC received: 1) bemnifosbuvir as monotherapy (primary analysis), and 2) the “combination antiviral population,” assessing combination therapy if the SOC includes other compatible antiviral drugs against COVID-19 (secondary analysis).The SUNRISE-3 patient population includes those aged =70 years (regardless of other risk factors), individuals aged =55 years with one or more risk factors, those aged =50 years with two or more risk factors, and individuals aged =18 years with specific risk factors, including immunocompromised conditions, all irrespective of COVID-19 vaccination status.The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the monotherapy arm in 2,200 patients. The trial includes two interim analyses by the DSMB to assess safety and futility, to be conducted after approximately 650 and 1,350 evaluable patients, respectively, after completion of Day 29 post treatment in the monotherapy arm. Bemnifosbuvir, a nucleotide polymerase inhibitor, 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.RZR, an oral NS5A inhibitor, has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and prior clinical studies. RZR has been administered to over 1,200 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. RZR’s PK profile supports once-daily dosing. Bemnifosbuvir targets the SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene which 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, XBB and EG.5.1.

Pharmaceuticals Groei van de industrie	5.95%
Inkomstengroei	-73.45%
Rendement op eigen vermogen	-72.53%
Nettomarge	n/a
Laatste winstupdate	31 Mar 2026

Datum	Inkomsten	Inkomsten	G+A Uitgaven	R&D-uitgaven
31 Mar 26	0	-170	30	0
31 Dec 25	0	-158	33	0
30 Sep 25	0	-147	39	0
30 Jun 25	0	-136	43	0
31 Mar 25	0	-139	46	0
31 Dec 24	0	-168	49	0
30 Sep 24	0	-174	47	0
30 Jun 24	0	-176	49	0
31 Mar 24	0	-164	50	0
31 Dec 23	0	-136	50	0
30 Sep 23	0	-131	51	0
30 Jun 23	0	-106	50	0
31 Mar 23	0	-109	49	0
31 Dec 22	0	-116	49	0
30 Sep 22	192	36	50	0
30 Jun 22	225	16	50	0
31 Mar 22	285	48	50	0
31 Dec 21	351	121	46	0
30 Sep 21	208	25	47	0
30 Jun 21	175	35	39	0
31 Mar 21	115	24	29	0
31 Dec 20	49	-11	22	0
30 Sep 20	0	-36	9	-7
30 Jun 20	0	-22	6	-4
31 Mar 20	0	-16	5	-1
31 Dec 19	0	-14	4	0

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/06/09 11:59
Aandelenkoers aan het einde van de dag	2026/06/09 00:00
Inkomsten	2026/03/31
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Eric Joseph	J.P. Morgan
Matthew Harrison	Morgan Stanley
Maxwell Skor	Morgan Stanley

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