Atea Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update
Atea Pharmaceuticals (AVIR) reported Q3 2024 financial results and provided updates on its HCV program. The company expects topline SVR12 results from its global Phase 2 Hepatitis C study (N=275) in December 2024. Earlier data showed 97% SVR12 rate in efficacy evaluable patients. The company ended Q3 with $482.8 million in cash and equivalents. Research and development expenses were $26.2 million, down from $28.2 million year-over-year. The company reported a net loss of $31.2 million for Q3 2024. Notably, Atea announced it will not pursue COVID-19 treatment development after its Phase 3 SUNRISE-3 trial failed to meet its primary endpoint.
Atea Pharmaceuticals (AVIR) ha pubblicato i risultati finanziari del terzo trimestre del 2024 e ha fornito aggiornamenti sul suo programma HCV. L'azienda prevede di ricevere i risultati SVR12 del suo studio globale di Fase 2 sull'Epatite C (N=275) a dicembre 2024. Dati precedenti hanno mostrato un tasso di SVR12 del 97% nei pazienti valutabili per l'efficacia. L'azienda ha chiuso il terzo trimestre con 482,8 milioni di dollari in contante e equivalenti. Le spese per ricerca e sviluppo sono state di 26,2 milioni di dollari, in calo rispetto ai 28,2 milioni dell'anno precedente. L'azienda ha riportato una perdita netta di 31,2 milioni di dollari per il terzo trimestre del 2024. È importante notare che Atea ha annunciato che non perseguirà lo sviluppo di trattamenti per il COVID-19 dopo che il suo trial di Fase 3 SUNRISE-3 non ha raggiunto l'obiettivo principale.
Atea Pharmaceuticals (AVIR) reportó los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre su programa de HCV. La compañía espera resultados de SVR12 en diciembre de 2024 de su estudio global de Fase 2 sobre la hepatitis C (N=275). Datos anteriores mostraron una tasa de SVR12 del 97% en pacientes evaluables por eficacia. La compañía terminó el tercer trimestre con 482.8 millones de dólares en efectivo y equivalentes. Los gastos de investigación y desarrollo fueron de 26.2 millones de dólares, una disminución respecto a los 28.2 millones del año anterior. La compañía reportó una pérdida neta de 31.2 millones de dólares para el tercer trimestre de 2024. Cabe destacar que Atea anunció que no seguirá el desarrollo de tratamientos para COVID-19 después de que su ensayo de Fase 3 SUNRISE-3 no lograra su objetivo principal.
Atea Pharmaceuticals (AVIR)는 2024년 3분기 재무 결과를 발표하고 HCV 프로그램에 대한 업데이트를 제공했습니다. 이 회사는 2024년 12월에 글로벌 2상 간염 C 연구(N=275)의 SVR12 최종 결과를 기대하고 있습니다. 이전 데이터는 효능 평가가 가능한 환자에서 97%의 SVR12 비율을 보여주었습니다. 이 회사는 3분기를 4억 8천 2백만 달러의 현금 및 현금성 자산으로 마감했습니다. 연구 및 개발 비용은 2천 6백 20만 달러로, 전년 대비 2천 8백 20만 달러에서 감소했습니다. 이 회사는 2024년 3분기 동안 3천 1백 20만 달러의 순손실을 보고했습니다. 주목할 만한 것은 Atea가 3상 SUNRISE-3 시험이 주요 목표를 충족하지 못한 후 COVID-19 치료 개발을 추진하지 않겠다고 발표했다는 것입니다.
Atea Pharmaceuticals (AVIR) a publié ses résultats financiers pour le troisième trimestre 2024 et a donné des nouvelles de son programme HCV. L'entreprise s'attend à recevoir les résultats SVR12 de son étude mondiale de Phase 2 sur l'hépatite C (N=275) en décembre 2024. Des données antérieures ont montré un taux de SVR12 de 97 % chez les patients évaluables en terme d'efficacité. L'entreprise a clos le troisième trimestre avec 482,8 millions de dollars en espèces et équivalents. Les dépenses de recherche et développement se sont élevées à 26,2 millions de dollars, en baisse par rapport à 28,2 millions de dollars l'année dernière. L'entreprise a déclaré une perte nette de 31,2 millions de dollars pour le troisième trimestre 2024. Il est à noter qu'Atea a annoncé qu'elle ne poursuivrait pas le développement de traitements contre le COVID-19 après que son essai de Phase 3 SUNRISE-3 n'ait pas atteint son objectif principal.
Atea Pharmaceuticals (AVIR) hat die Finanzzahlen für das 3. Quartal 2024 veröffentlicht und Informationen zu seinem HCV-Programm bereitgestellt. Das Unternehmen erwartet die SVR12-Ergebnisse seiner globalen Phase-2-Studie zur Hepatitis C (N=275) im Dezember 2024. Frühere Daten zeigten eine SVR12-Rate von 97% bei effizient bewertbaren Patienten. Das Unternehmen beendete das 3. Quartal mit 482,8 Millionen Dollar an Bargeld und Äquivalenten. Die Forschungs- und Entwicklungskosten beliefen sich auf 26,2 Millionen Dollar, was einen Rückgang gegenüber 28,2 Millionen Dollar im Vorjahr darstellt. Das Unternehmen berichtete über einen Nettoverlust von 31,2 Millionen Dollar für das 3. Quartal 2024. Bemerkenswert ist, dass Atea bekannt gab, die Entwicklung von COVID-19-Behandlungen nach dem Scheitern der Phase-3-Studie SUNRISE-3, die nicht das primäre Ziel erreichte, nicht weiterverfolgen zu wollen.
- Strong cash position of $482.8 million
- Promising HCV Phase 2 interim data showing 97% SVR12 rate
- Reduced R&D expenses by $2.0 million year-over-year
- Reduced G&A expenses by $1.6 million year-over-year
- Net loss of $31.2 million in Q3 2024
- Failed Phase 3 SUNRISE-3 COVID-19 trial
- Discontinuation of COVID-19 program
Insights
Q3 2024 results reveal key financial metrics and strategic shifts.
Net loss of
The Phase 2 HCV study results expected in December 2024 are pivotal, with early data showing promise. The lead-in cohort demonstrated
The strategic discontinuation of COVID-19 program following SUNRISE-3 trial results allows full focus on the HCV program. The planned Phase 3 initiation in early 2025, pending FDA meeting, positions the company for potential market entry with a differentiated product targeting unmet needs in substance abuse and comorbidity patient populations.
Topline SVR12 Results from Global Phase 2 Hepatitis C Virus (HCV) Study (N=275) Expected Q4’24
New Data Supportive of HCV Combination to be Presented at the American Association for the Study of Liver Diseases’ (AASLD’s) The Liver Meeting 2024
Pharmacokinetic Data for Bemnifosbuvir to be Presented at American College of Pharmacometrics Meeting
Conference Call at 4:30 pm ET Today
BOSTON, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), 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 third quarter ended September 30, 2024 and provided a business update.
“We continue to make significant progress in our HCV program with the combination of bemnifosbuvir and ruzasvir, which has a potential best-in-class profile. In the near term, we look forward to sharing topline results in early December from our Phase 2 combination study and initiating the global Phase 3 program early next year,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “The unrelenting high rate of new HCV infections underscores the need for new innovative therapies that can address the unmet needs of today’s HCV patients, particularly those with substance abuse disorders and comorbidities. The HCV commercial market is expected to remain large, with global net sales exceeding
Hepatitis C Virus (HCV)
Phase 2 HCV Combination Study: Atea is currently completing a global Phase 2 clinical study evaluating the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of HCV. This study, which has enrolled 275 treatment-naïve patients, both with and without compensated cirrhosis, is designed to evaluate the safety and efficacy of eight weeks of treatment with the combination consisting of once-daily bemnifosbuvir 550 mg and ruzasvir 180 mg. The primary endpoints of the study are safety and sustained virologic response at 12 weeks post-treatment (SVR12) in the per-protocol treatment adherent population. Secondary and other endpoints include SVR12 in the per-protocol population regardless of treatment adherence (efficacy evaluable), virologic failure and resistance. Atea expects to report topline Phase 2 SVR12 results from this study in early December 2024.
At the European Association of the Study of the Liver (EASL) Congress in June 2024, Atea presented clinical data from the lead-in cohort (n=60) of the ongoing Phase 2 study. With an 8-week treatment duration, data from the lead-in cohort of non-cirrhotic patients showed a
Data also presented at EASL included additional preclinical data further demonstrating a high barrier to resistance and favorable pharmacokinetics (PK) for bemnifosbuvir and a low risk of drug-drug interactions for ruzasvir. Atea has previously reported a low risk of drug-drug interactions for bemnifosbuvir.
Atea is currently planning for an End of Phase 2 meeting with the US Food and Drug Administration early in the first quarter of 2025 to support the initiation of the Phase 3 program.
Atea has selected and is manufacturing a fixed dose combination (FDC) tablet for its upcoming Phase 3 program. The FDC tablet reduces the daily pill count from four to two tablets, enhancing patient convenience, with no food effect demonstrated in recent studies.
New Data Presentations at Upcoming Scientific Meetings
At The Liver Meeting 2024, being held from November 15-19, 2024, three posters supportive of the combination of bemnifosbuvir and ruzasvir as a potential treatment for HCV will be presented. The posters detail additional safety and resistance data for bemnifosbuvir and present multiscale modeling data estimating the effectiveness of the combination of bemnifosbuvir and ruzasvir in blocking HCV replication and viral assembly and secretion.
At the American College of Pharmacometrics meeting, being held on November 11, 2024, supportive data from an integrated population PK model that was developed to simultaneously characterize the PK profile of bemnifosbuvir and its metabolites will be presented.
COVID-19
Phase 3 SUNRISE-3 Trial: In September 2024, Atea announced results from the Phase 3 SUNRISE-3 trial, a global, multicenter, randomized, double-blind, placebo-controlled study evaluating bemnifosbuvir in patients with mild to moderate COVID-19. The trial did not meet its primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29. Total enrollment for the monotherapy cohort consisted of 2,221 high-risk patients randomized 1:1 to receive bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days. In the trial, bemnifosbuvir was shown to be generally safe and well tolerated.
The evolving nature of COVID-19, including milder disease presentations and a reduction in hospitalizations due to COVID-19 related severe respiratory disease, pose significant challenges in demonstrating a clinical impact with a direct-acting antiviral such as bemnifosbuvir. Given the trial results and the changing landscape of the pandemic, Atea will not pursue a regulatory pathway forward for bemnifosbuvir for COVID-19.
Third Quarter 2024 Financial Results
Cash, Cash Equivalents and Marketable Securities:
Research and Development Expenses: Research and development expenses decreased by
General and Administrative Expenses: General and administrative expenses decreased by
Interest Income and Other, Net: Interest income and other, net, decreased by
Income Taxes: We recorded income tax expense of
| Condensed Consolidated Statement of Operations and Comprehensive Loss | ||||||||||||||||
| (in thousands, except share and per share amounts) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 26,159 | $ | 28,181 | $ | 118,430 | $ | 79,198 | ||||||||
| General and administrative | 11,043 | 12,604 | 35,494 | 38,391 | ||||||||||||
| Total operating expenses | 37,202 | 40,785 | 153,924 | 117,589 | ||||||||||||
| Loss from operations | (37,202 | ) | (40,785 | ) | (153,924 | ) | (117,589 | ) | ||||||||
| Interest income and other, net | 6,277 | 7,864 | 19,782 | 21,466 | ||||||||||||
| Loss before income taxes | (30,925 | ) | (32,921 | ) | (134,142 | ) | (96,123 | ) | ||||||||
| Income tax expense | (226 | ) | (221 | ) | (700 | ) | (669 | ) | ||||||||
| Net loss | $ | (31,151 | ) | $ | (33,142 | ) | $ | (134,842 | ) | $ | (96,792 | ) | ||||
| Other comprehensive loss | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale investments | 921 | 48 | 434 | 422 | ||||||||||||
| Comprehensive loss | $ | (30,230 | ) | $ | (33,094 | ) | $ | (134,408 | ) | $ | (96,370 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.37 | ) | $ | (0.40 | ) | $ | (1.60 | ) | $ | (1.16 | ) | ||||
| Weighted-average number of common shares - basic and diluted | 84,422,000 | 83,399,769 | 84,198,117 | 83,374,328 | ||||||||||||
| Selected Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and marketable securities | 482,813 | 578,106 | ||||||
| Working capital(1) | 461,716 | 558,079 | ||||||
| Total assets | 490,957 | 594,968 | ||||||
| Total liabilities | 32,436 | 39,776 | ||||||
| Total stockholder's equity | 458,521 | 555,192 | ||||||
| (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 September 30, 2024 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 2024 financial results and provide a business update today at 4:30 p.m. ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Atea Pharmaceuticals website at ir.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 archive of the audio webcast will be available on Atea Pharmaceuticals’ website approximately two hours after the conference call and will remain available for at least 90 days following the event.
About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV)
Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The PK profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Bemnifosbuvir has been shown to have a low risk for drug-drug interactions. Bemnifosbuvir has been administered to over 2,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients.
Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,500 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir 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 Atea’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. Our lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor and ruzasvir, an NS5A inhibitor, to treat hepatitis C virus. For more information, please visit www.ateapharma.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the anticipated timing for reporting the topline results from Atea’s Phase 2 trial of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV, meeting with the FDA, and potential initiation of the HCV Phase 3 program. When used herein, words including “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, dependence on the success of Atea’s most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors 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 Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release.
Contacts
Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
barnes.jonae@ateapharma.com
Will O’Connor
Precision AQ
212-362-1200
will.oconnor@precisionaq.com
FAQ
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