Atea Pharmaceuticals Inc
For the period ended Mar 31, 2025. Filed May 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0000950170-24-123447
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0000950170-25-069367
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 111 previous paragraphs and 123 current paragraphs.
49 unchanged; 37 reworded; 36 added; 22 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (36)
Current report
HCV is a blood-borne, positive-sense, single-stranded ribonucleic acid ("RNA") virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease, liver transplants and liver cancer in the United States ("US"), Europe and Japan.
Current report
Despite the availability of direct-acting antiviral (“DAA”) oral combination treatment regimens and eradication efforts by the World Health Organization and others, HCV continues to be a serious viral disease. An estimated 50 million people globally live with chronic HCV infection, with approximately 1 million new infections occurring each year. In 2022, HCV led to an estimated 242,000 deaths. These deaths are primarily attributable to cirrhosis and hepatocellular cancer, each of which are serious long-term consequences resulting from prolonged exposure, generally up to 20 years of HCV infection.
Current report
In the US, it is estimated that there are between 2.4 and 4.0 million persons infected with untreated HCV. Further it is reported that on an annual basis in the US, there are greater than 160,000 newly reported HCV infections. This incidence of newly reported infections outpaces substantially stagnant rates of treatment.
Current report
In the US and elsewhere, HCV is increasingly affecting younger people, with high case rates among those between 20 to 49 years of age. Since recently infected and younger patient populations are less likely to have developed cirrhosis given the relatively shorter cumulative exposure to the virus, there has been a trend in the US of decreasing incidence of cirrhosis among individuals with HCV infection. It is estimated that less than 10% of the HCV-infected population in the US has cirrhosis.
Current report
In 2024, global net sales of branded HCV therapeutics known in the US as Epclusa® and Mavyret® together with the authorized generic copies of Epclusa exceeded $2.9 billion with the US contributing approximately 50% of these sales. Given the large number of patients currently infected with HCV and high rates of annual incidence, it is expected that a substantial global market will exist for the foreseeable future.
Current report
Our Goal
Current report
The objective of our HCV development program is to improve upon the current standard of care ("SOC") by offering, the regimen of bemnifosbuvir and ruzasvir, if successfully developed and approved, as a differentiated pan-genotypic protease inhibitor-free therapeutic for HCV-infected patients. We believe that a novel treatment, with a profile that can be easily prescribed for and administered to today’s population of HCV-infected patients (e.g. young, newly infected, non-cirrhotic) would be a significant improvement to the current SOC.
Current report
Presently, there are no short-course (i.e., 8 week) nucleoside inhibitor-based, pan-genotypic HCV treatment regimens. Results from the clinical and nonclinical studies we have conducted to date, including a global Phase 2 clinical trial which enrolled 275 HCV infected patients, have shown that the regimen of bemnifosbuvir and ruzasvir offers high potency, a low risk for drug-drug interactions, good tolerability and convenience in that it can be taken with or without food which we believe would offer a significant improvement to the current SOC, if approved.
Current report
Based upon the encouraging clinical and nonclinical results to date, we have commenced Phase 3 clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV. In the Phase 3 clinical trials, we will evaluate the regimen as an 8-week treatment duration for patients without cirrhosis and a 12-week treatment duration for patients with compensated cirrhosis. We believe that the regimen of bemnifosbuvir and ruzasvir, if approved, will rapidly become a therapy preferred by both HCV prescribers and patients.
Current report
Key Clinical Trial Results
Current report
In December 2024, we announced that the global Phase 2 study evaluating the regimen of bemnifosbuvir and ruzasvir had met its primary endpoints of safety and sustained virologic response (“SVR”) at 12 weeks post treatment (“SVR12”). The regimen of bemnifosbuvir and ruzasvir was generally well-tolerated with no drug-related serious adverse events (“SAEs”) or treatment discontinuations.
Current report
Primary efficacy endpoint results showed a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after 8 weeks of treatment with the regimen. The efficacy evaluable patient population, which included 17% treatment non-adherent patients, achieved a 95% (242/256) SVR12 rate. Additional results from the Phase 2 study showed in treatment adherent patients who were non-cirrhotic and infected with genotypes 1-4, an SVR12 rate of 99% (178/179) was achieved, demonstrating pan-genotypic potency. Treatment adherent patients with cirrhosis achieved an 88% (30/34) SVR12 rate. Although viral kinetics were slower in cirrhotic patients, all cirrhotic patients (100%; 34/34) achieved an end of treatment response at Week 8.
Current report
Phase 3 Clinical Development
Current report
In January 2025, we met with the U.S. Food and Drug Administration (“FDA”) at an End-of-Phase 2 meeting to seek feedback on the design of the Phase 3 clinical trials. The End-of-Phase 2 feedback from the FDA supported our decision to advance the program to Phase 3 clinical development.
Current report
The global HCV Phase 3 program we are currently conducting includes two randomized, open label Phase 3 trials comparing the regimen of bemnifosbuvir and ruzasvir to sofosbuvir and velpatasvir in patients with chronic HCV infection. The overall clinical trial design is identical for each trial. We have begun patient enrollment in C-BEYOND, the Phase 3 clinical trial being conducted in the U.S and Canada and we expect to initiate patient enrollment in C-FORWARD, the Phase 3 clinical trial to be conducted outside of North America in mid-2025.
Current report
Each trial is expected to enroll approximately 880 treatment-naïve patients, both with and without compensated cirrhosis. Patients will be stratified by genotype and cirrhosis status, and patients with human immunodeficiency virus co-infection will be allowed. For non-cirrhotic patients, 8 weeks of treatment with the regimen of bemnifosbuvir and ruzasvir will be compared to 12 weeks of sofosbuvir and velpatasvir. For cirrhotic patients, 12 weeks of bemnifosbuvir and ruzasvir will be compared to 12 weeks of sofosbuvir and velpatasvir. The intention of the global geographic footprint of the Phase 3 clinical trials is to assist us in enrolling patients with varied HCV genotypes.
Current report
Respiratory and Other RNA Virus Infections
Current report
In an effort to enhance efficiency in the management of infrastructure expenses, in the first quarter of 2025, we reduced our workforce by approximately 25%. This workforce reduction is expected to result in aggregate cost savings of approximately $15.0 million through 2027.
Current report
In April 2025, our Board of Directors (the “Board”) authorized the repurchase of up to $25.0 million of our common stock (“Share Repurchase Program”). This authorization reflects our commitment to return capital to our stockholders while maintaining the capacity to complete our Phase 3 clinical development of the regimen of bemnifosbuvir and ruzasvir and execute on our strategic business plans. Repurchases under the Share Repurchase Program may be made in the open market, in privately negotiated transactions or otherwise, with the amount and timing of repurchases to be determined at our discretion, or under a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)(1) under the Exchange Act.
Current report
As previously announced on December 16, 2024, we engaged Evercore LLC, a global independent investment bank, to identify potential opportunities to enhance stockholder value. The process includes a review of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions. The process is ongoing, and we continue to evaluate all options to maximize stockholder value. There is no assurance that the process will result in the completion of any specific transaction or outcome.
Current report
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $425.4 million. Net cash used in operating activities was $30.6 million for the three months ended March 31, 2025. In an effort to enhance efficiency in the management of infrastructure expenses, in the first quarter of 2025, we reduced our workforce by approximately 25%. This workforce reduction is expected to result in aggregate cost savings of approximately $15 million through 2027. As noted above, in April 2025, our Board authorized the Share Repurchase Program. This authorization reflects our commitment to return capital to our stockholders while maintaining the capacity to complete our Phase 3 clinical development of the regimen of bemnifosbuvir and ruzasvir and execute on our strategic business plans. Based on our current plans, we anticipate our existing financial resources, net of the $25.0 million return of capital, will allow us to advance our current and planned clinical programs to and through key inflection points including the completion of clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV.
Current report
conduct Phase 3 clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV which includes the purchase of comparator drug;
Current report
continue discovery activities to identify within our compound library other potential product candidates for the treatment of diseases caused by single stranded RNA viruses;
Current report
manufacture the regimen of bemnifosbuvir and ruzasvir in fixed dose tablets for use in the Phase 3 clinical trials, regulatory approvals, and, if approved, for potential commercialization, for the treatment of HCV;
Current report
hire additional personnel, if necessary, to support our activities; and
Current report
Research and Development Expenses
Current report
The following table summarizes our external research and development expenses by indication and internal research and development expenses:
Current report
General and Administrative Expenses
Current report
Interest Income and Other, Net
Current report
Income Taxes
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Interest Income and Other, Net
Current report
Income Taxes
Current report
the outcome of our ongoing evaluation of strategic alternatives;
Current report
Our critical accounting policies are those policies that require the most significant judgments and estimates in the preparation of the financial statements. Management has determined that our most critical accounting policies are those relating to revenue recognition, accrued research and development expenses and stock-based compensation.
Removed paragraphs (22)
Previous report
Bemnifosbuvir
Previous report
Derived from our internal discovery program, bemnifosbuvir, is an investigational, novel, orally administered guanosine nucleotide analog polymerase inhibitor that combines a unique nucleotide scaffold with novel double prodrugs for the intended purpose of inhibiting the enzymes central to viral replication. We believe that utilizing this double prodrug moiety approach allows us to maximize formation of the active metabolite potentially resulting in an oral antiviral product candidate that is selective for and highly effective at preventing replication and transcription of HCV and other single ssRNA viruses while avoiding toxicity to host cells.
Previous report
Despite the availability of direct acting antiviral oral combination treatment regimens, HCV continues to be a serious viral disease in the US and globally. Approximately 58 million people globally are living with chronic HCV infection. The WHO estimates a global incidence of 1.5 million new infections and 290,000 deaths per year.
Previous report
In the US, HCV is recognized as a health crisis with approximately 2.4 million individuals estimated to be infected. Prevalence of HCV in the US is expected to remain constant over the coming years as rising HCV incidence largely attributable to the opioid crisis, IV drug use, and HCV reinfection, especially among younger adults, offsets the number of new patients treated.
Previous report
Our HCV strategy focuses on the development of bemnifosbuvir in combination with ruzasvir, an HCV NS5A inhibitor, a product candidate which we have exclusively licensed from Merck & Co, Inc. (“Merck”). Combination therapy utilizing two or more direct acting antivirals with different mechanisms of action is a scientifically and clinically well-established approach that is utilized by currently available human immunodeficiency virus, hepatitis B virus and HCV treatment regimens.
Previous report
The objective of our HCV development program is to improve upon the current SOC by offering, if successfully developed, the combination of bemnifosbuvir and ruzasvir, as a potentially differentiated eight-week duration, pan-genotypic protease inhibitor-free regimen with low risk of drug-drug interactions for HCV-infected patients with or without cirrhosis.
Previous report
In June 2024, at the European Association for the Study of Liver Disease Congress, we presented data from the 60 patient lead-in cohort. These data showed an SVR12 rate of 97% in the efficacy evaluable population following the eight weeks of treatment. Two patients in the lead-in cohort (genotype 1b and genotype 2b) experienced a post-treatment relapse. Each of these patients had low plasma drug levels and viral mutations that were similar at baseline and 12-weeks post-treatment time points, which we believe indicates that the relapse was due to treatment non-adherence rather than viral resistance. The data from the lead-in cohort also showed that viral kinetics were similar in genotype 1 and genotype 3 infected patients, including a 100% SVR12 rate in historically difficult-to-treat genotype 3 infected patients. In the lead-in cohort, the combination of bemnifosbuvir and ruzasvir was generally well tolerated. There were no drug-related serious adverse events or treatment discontinuations, and adverse events were mostly mild.
Previous report
Final SVR12 results from all 275 patients enrolled in the global Phase 2 study are anticipated in the fourth quarter of 2024. If the Phase 2 study is successfully completed, subject to discussion and alignment with regulatory authorities, we anticipate initiating a Phase 3 clinical development program in 2025.
Previous report
Other
Previous report
Roche License Agreement
Previous report
In October 2020, with Roche, we entered into a License Agreement (“Roche License Agreement”) with F. Hoffmann-LaRoche Ltd. and Genentech, Inc. (together, “Roche”) in connection with the global development, manufacture and commercialization of bemnifosbuvir, products containing bemnifosbuvir or AT-511, the free base of bemnifosbuvir, and related companion diagnostics. During the term of the Roche License Agreement, Roche and we jointly developed bemnifosbuvir for COVID-19 on a worldwide-basis and equally shared the costs associated with such development activities.
Previous report
The Roche License Agreement terminated on February 10, 2022, and, accordingly, our obligations to share costs with Roche also ended. As a result of the termination of the Roche License Agreement, we regained worldwide exclusive rights from Roche to research, develop, manufacture and commercialize bemnifosbuvir, products containing bemnifosbuvir and related companion diagnostics in all fields of use.
Previous report
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $482.8 million. Net cash used in operating activities was $105.1 million for the nine months ended September 30, 2024.
Previous report
advance the clinical development of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV which is expected to include later stage Phase 3 development, if the Phase 2 clinical trial we are currently conducting is successful;
Previous report
manufacture the combination of bemnifosbuvir and ruzasvir in a fixed dose tablet for use in potential Phase 3 development and for potential commercialization, if approved, of the combination for the treatment of HCV;
Previous report
hire additional research, development and administrative personnel; and
Previous report
As discussed in Note 3 to our unaudited condensed consolidated financial statements, during the term of the Roche License Agreement which terminated in February 2022, we and Roche shared certain manufacturing and clinical development costs on a 50/50 basis. Billings to us by Roche for our percentage share of such expenses were recorded in research and development expenses. During the three months ended September 30, 2024 and 2023, we recorded a net reduction to research and development expenses of $0 million and $3.7 million, respectively, related to credits received from Roche. During the nine months ended September 30, 2024 and 2023, we recorded a net reduction to research and development expenses of $1.3 million and $12.6 million, respectively, related to credits received from Roche. These credits were the result, following the termination of the Roche License Agreement, of changes and adjustments by Roche in estimated amounts of expenses reported by Roche during the period in which we and Roche shared costs associated with the development of bemnifosbuvir. We do not anticipate to receive any additional credits from Roche or record any related additional net reductions to research and development expenses.
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report
Research and development expenses increased by $39.2 million from $79.2 million for the nine months ended September 30, 2023 to $118.4 million for the nine months ended September 30, 2024. The net increase was primarily driven by higher external spend related to our COVID-19 Phase 3 SUNRISE-3 clinical trial and our HCV Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir.
Previous report
General and administrative expenses decreased by $2.9 million from $38.4 million for the nine months ended September 30, 2023 to $35.5 million for the nine months ended September 30, 2024. The net decrease was primarily related to lower professional fees.
Previous report
We recorded an income tax expense of $0.7 million for each of the nine months ended September 30, 2024 and 2023.
Previous report
Our critical accounting policies and estimates are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023. We believe that these accounting policies are critical to understanding our historical and future performance, as these policies relate to significant areas involving management’s judgments and estimates. During the three and nine months ended September 30, 2024, there were no material changes to our critical accounting policies and estimates from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2023.
Reworded paragraphs (37)
Previous wording
We are a clinical-stage biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biology, biochemistry and virology to discover and develop novel orally administered product candidates to treat serious viral diseases. Currently, we are developing our lead product candidate, the combination of bemnifosbuvir and ruzasvir, an NS5A inhibitor, for the treatment of hepatitis C virus (“HCV”) infection.
Current wording
We are a clinical-stage biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biology, biochemistry and virology to discover and develop novel orally administered product candidates to treat serious viral diseases. Our lead product candidate is the regimen consisting of bemnifosbuvir and ruzasvir, which we are developing for the treatment of hepatitis C virus (“HCV”) infection. In April 2025, we commenced enrollment of patients in the HCV Phase 3 program evaluating the regimen.
Previous wording
The ongoing global Phase 2 clinical trial of bemnifosbuvir in combination with ruzasvir in treatment-naïve, HCV-infected patients either without cirrhosis or with compensated cirrhosis is fully enrolled with 275 HCV-infected, treatment-naïve patients across HCV GTs. The patients enrolled in the trial include a lead-in cohort of 60 patients without cirrhosis. This study 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 (“SVR”) at week 12 post-treatment (“SVR12”) in the per-protocol adherent population. Other virologic endpoints include SVR12 in the per-protocol population regardless of treatment adherence, which we refer to as the efficacy evaluable population, virologic failure, SVR at week 24 post-treatment and resistance.
Current wording
The global Phase 2 study enrolled 275 HCV treatment-naïve patients, both with and without compensated cirrhosis. The study was designed to evaluate the safety and efficacy of 8 weeks of treatment with the regimen consisting of once-daily bemnifosbuvir 550 mg and ruzasvir 180 mg. The primary endpoints were safety and SVR12 in the per-protocol treatment adherent population. Secondary and other endpoints included SVR12 in the efficacy evaluable population (a broader analysis population which included treatment non-adherent patients), SVR at 24 weeks post treatment (“SVR24”), virologic failure and resistance.
Previous wording
In September 2024 we announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir versus placebo for the treatment of COVID-19. The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19. We believe that the unfavorable results from this study were impacted by the constantly evolving variants of COVID-19 and rapidly changing natural history of the disease, which has trended toward a milder disease where it makes it difficult to demonstrate the impact of a direct acting antiviral. This has led us to discontinue efforts to develop bemnifosbuvir for the treatment of COVID-19. In SUNRISE-3, bemnifosbuvir was generally safe and well tolerated. Currently, we continue to wind down and close out the study.
Current wording
In September 2024 we announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir versus placebo for the treatment of Coronavirus Disease 2019 ("COVID-19"). The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19. We believe that the unfavorable results from this study were impacted by the constantly evolving variants of COVID-19 and rapidly changing natural history of the disease, which during the study period trended toward a milder disease. This led us to discontinue efforts to develop bemnifosbuvir for the treatment of COVID-19. In SUNRISE-3, bemnifosbuvir was generally safe and well tolerated. In April 2025, we completed the close out of the study.
Previous wording
Separately, we are engaging in efforts to discover a potential protease inhibitor product candidate for the treatment of respiratory and other diseases resulting from infection with single stranded RNA viruses. Our efforts in this regard remain at early stages and no clinical candidate has yet to be nominated.
Current wording
Separately, we are engaged in efforts to discover a product candidate for the treatment of respiratory diseases resulting from infection with single stranded RNA viruses. Additionally, we engaged in efforts to screen compounds which are a part of our compound library to assess antiviral activity against other RNA viral infections. Each of these efforts are at early stages and no clinical candidates have yet to be nominated.
Previous wording
We do not have any products approved for sale and have not generated any product revenue since inception. We do not anticipate generating any revenue from product sales for the foreseeable future. Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings, collaborative or other arrangements with third parties, or through other sources of financing. Our failure to meet the primary endpoints of our COVID-19 SUNRISE-3 Phase 3 clinical trial may make such financing more difficult. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
Current wording
We do not have any products approved for sale and have not generated any product revenue since inception. We do not anticipate generating any revenue from product sales for the foreseeable future. Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings, collaborative or other arrangements with third parties, or through other sources of financing. Our failure to meet the primary efficacy endpoint of our COVID-19 SUNRISE-3 Phase 3 clinical trial may make such financing more difficult. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
Previous wording
In December 2021, we entered into a license agreement (“Merck License Agreement”) with MSD International GmbH, an affiliate of Merck & Co., Inc. (“Merck”) for the development, manufacture and commercialization of ruzasvir. Ruzasvir is an investigational NS5A inhibitor we are developing in combination with bemnifosbuvir for the treatment of HCV.
Current wording
In December 2021, we entered into a license agreement (“Merck License Agreement”) with MSD International GmbH, an affiliate of Merck & Co., Inc. (“Merck”) for the development, manufacture and commercialization of ruzasvir. Ruzasvir is the investigational NS5A inhibitor we are developing in combination with bemnifosbuvir for the treatment of HCV.
Previous wording
In addition to a non-refundable upfront payment that we made in February 2022, we will be required to pay Merck milestone payments upon our achievement of certain development, regulatory and sales-based milestones. Additionally, we will pay Merck tiered royalties based on annual net sales of Products ranging from high single digits to mid-teens percentages. Our royalty payment obligations will continue until the later of (i) the expiration of the last to expire valid claim of a licensed Merck patent claiming such Product and (ii) a period of years after the first commercial sale of such Product in such country. We may terminate the Merck License Agreement for convenience upon prior written notice. The first potential milestone, in the amount of $5.0 million, would be payable upon the commencement of the HCV Phase 3 clinical trial that we are currently planning to initiate in 2025 subject to discussion and alignment with regulatory authorities.
Current wording
In addition to a non-refundable upfront payment that we made in February 2022, we will be required to pay Merck milestone payments upon our achievement of certain development, regulatory and sales-based milestones. Additionally, we will pay Merck tiered royalties based on annual net sales of Products ranging from high single digits to mid-teens percentages. Our royalty payment obligations will continue until the later of (i) the expiration of the last to expire valid claim of a licensed Merck patent claiming such Product and (ii) a period of years after the first commercial sale of such Product in such country. We may terminate the Merck License Agreement for convenience upon prior written notice. The first milestone in the amount of $5.0 million became due and payable when we enrolled our first patient in C-BEYOND, the Phase 3 clinical trial that we are currently conducting in the US and Canada evaluating the regimen of bemnifosbuvir and ruzasvir. The Company expects to recognize the milestone payment as research and development expense in the three months ended June 30, 2025. The next potential milestone, in the amount of $10.0 million, is payable upon acceptance by the FDA of a new drug application covering a product candidate including ruzasvir which we currently anticipate will be the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV.
Previous wording
We expect that our net cash used in operating activities will remain significant as we advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, manufacture such products at commercial scale and otherwise pursue commercialization activities; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. In addition, we may incur additional costs as we continue to operate as a public company. We believe that our available cash and cash equivalents will be sufficient to fund our planned operations through 2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect.
Current wording
We expect that our net cash used in operating activities will remain significant as we advance our HCV product candidate through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, manufacture such product at commercial scale and otherwise pursue commercialization activities; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and, if necessary, hire additional personnel. In addition, we may incur additional costs as we continue to operate as a public company. We believe that our available cash, cash equivalents and marketable securities, net of the $25.0 million return of capital, will be sufficient to fund our planned operations through 2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect.
Previous wording
continue discovery and IND-enabling activities in anticipation of nominating a protease inhibitor product candidate for the treatment of respiratory and other diseases resulting from infection with single stranded RNA viruses;
Current wording
continue discovery and IND-enabling activities in anticipation of nominating a protease inhibitor product candidate for the treatment of respiratory diseases resulting from infection with single stranded RNA viruses;
Previous wording
seek market approval and prepare for potential commercialization of product candidates we may successfully develop;
Current wording
seek market approval and prepare for potential commercialization of any product candidates that we may successfully develop;
Previous wording
If our development efforts for our product candidates are successful and result in commercialization, we may generate revenue in the future from product sales. Additionally, we may generate revenue from collaboration or license agreements that we may enter into with third parties.
Current wording
If our product candidate development efforts are successful and result in commercialization, we may generate revenue in the future from product sales. Additionally, we may generate revenue from collaboration or license agreements that we may enter into with third parties.
Previous wording
Substantially all of our research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses include external costs consisting of fees paid to third parties, including CROs and CMOs, to conduct certain research and development activities on our behalf and consulting costs, as well as internal costs consisting of payroll and personnel-related expenses, including salaries and bonuses, employee benefit costs and stock-based compensation expenses for our research and product development employees and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities attributable to our research and development personnel. We expense both internal and external research and development expenses as they are incurred. In circumstances where amounts have been paid in advance or in excess of costs incurred, we record a prepaid expense, which is expensed as services are performed or goods are delivered.
Current wording
Substantially all of our research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses include external costs consisting of fees paid to third parties, including CROs and CMOs, to conduct certain research and development activities on our behalf, consulting costs and in the case of our HCV Phase 3 program, costs to purchase comparator drug. Research and development expenses also include internal costs consisting of payroll and personnel-related expenses, including salaries and bonuses, employee benefit costs and stock-based compensation expenses for our research and development employees and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities attributable to our research and development personnel. We expense both internal and external research and development expenses as they are incurred. In circumstances where amounts have been paid in advance or in excess of costs incurred, we record a prepaid expense, which is expensed as services are performed or goods are delivered.
Previous wording
A significant portion of our research and development costs have been external costs, which we track by therapeutic area. We have not historically tracked our internal research and development expenses by therapeutic area as they are deployed across multiple programs.
Current wording
A significant portion of our research and development costs have been external costs, which we track by therapeutic area. We have not historically tracked our internal research and development expenses or early stage discovery costs by therapeutic area as they are deployed across multiple programs. Early stage discovery activities consist of assessing the antiviral activity and other properties of select compounds derived from our compound library against respiratory and other RNA viral infections.
Previous wording
We are focusing substantially all of our resources on the development of our product candidates. We expect our research and development expenses to vary quarter over quarter particularly as we advance our HCV clinical program into Phase 3 clinical development if our Phase 2 clinical trial is successful, pursue regulatory approval of our product candidates and prepare for the possible commercialization of these product candidates. Predicting the timing or cost to complete our clinical programs, validate our commercial manufacturing and supply processes and manufacture of product at commercial scale is difficult and delays may occur because of many factors, including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate or the time to complete planned clinical trials is extended due to delays in enrollment or otherwise, we could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, we are unable to predict with any certainty when our product candidates, if ever, will receive regulatory approval.
Current wording
Substantially all of our resources are focused on the development of our product candidates. We expect our research and development expenses to vary quarter over quarter particularly as we advance our Phase 3 HCV clinical program and prepare for the possible commercialization of the regimen of bemnifosbuvir and ruzasvir if the Phase 3 clinical development is successful. Predicting the timing or cost to complete our clinical programs, validate our commercial manufacturing and supply processes and manufacture of product at commercial scale is difficult and delays may occur because of many factors, including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate or the time to complete planned clinical trials is extended due to delays in enrollment or otherwise, we could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, we are unable to predict with any certainty when our HCV product candidate or any other product candidate we may develop will receive regulatory approval, if ever.
Previous wording
General and administrative expenses consist principally of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, allocated overhead, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses.
Current wording
General and administrative expenses consist principally of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, business insurance, allocated overhead, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses.
Previous wording
We anticipate that our general and administrative expenses may increase, including in connection with any future expansion of our organization for potential commercialization of our product candidates, as a result of increased personnel costs, expanded infrastructure, increased consulting, legal and accounting services costs associated with complying with Nasdaq and SEC requirements and increased investor relations costs.
Current wording
We anticipate that our general and administrative expenses may increase, including in connection with any future expansion of our organization for potential commercialization of our product candidates, as a result of increased personnel costs, expanded infrastructure, increased consulting, legal and accounting services, costs associated with complying with The Nasdaq Global Select Market and Securities and Exchange Commission requirements and increased investor relations costs.
Previous wording
Research and development expenses decreased by $2.0 million from $28.2 million for the three months ended September 30, 2023 to $26.2 million for the three months ended September 30, 2024. The net decrease was primarily driven by lower external spend related to our COVID-19 Phase 3 SUNRISE-3 clinical trial offset by higher spend related to our HCV Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir.
Current wording
Research and development expenses decreased by $28.0 million from $57.6 million for the three months ended March 31, 2024 to $29.6 million for the three months ended March 31, 2025. The net decrease was primarily driven by lower external spend as our COVID-19 Phase 3 SUNRISE-3 clinical trial was completed in 2024. The decrease was offset by an increase in external spend related principally to startup activities for our HCV Phase 3 clinical development including the purchase of comparator drug. Additionally, a decrease in internal research and development expenses was primarily related to lower stock-based compensation expense in the three months ended March 31, 2025.
Previous wording
General and administrative expenses decreased by $1.6 million from $12.6 million for the three months ended September 30, 2023 to $11.0 million for the three months ended September 30, 2024. The net decrease was primarily related to lower professional fees.
Current wording
General and administrative expenses decreased by $2.8 million from $12.2 million for the three months ended March 31, 2024 to $9.5 million for the three months ended March 31, 2025. The net decrease was primarily related to lower stock-based compensation expense, partially offset by increased professional fees.
Previous wording
Interest income and other, net, decreased by $1.6 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023, primarily due to lower investment balances.
Current wording
Interest income and other, net, decreased by $1.9 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024, primarily due to lower investment balances.
Previous wording
We recorded an income tax expense of $0.2 million for each of the three months ended September 30, 2024 and 2023.
Current wording
Income tax expense was $0.2 million for the three months ended March 31, 2025 and 2024.
Previous wording
We believe we are well capitalized to advance our current programs. We had $482.8 million in cash, cash equivalents and marketable securities at September 30, 2024. Based on our current plans, we anticipate these financial resources will allow us to advance our current and planned clinical programs to and through key inflection points including the completion of clinical development of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV and to fund our activities through 2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect.
Current wording
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $425.4 million. We believe that our available cash, cash equivalents and marketable securities will be sufficient to fund the recently authorized Share Repurchase Program and our planned operations through 2027, including the completion of the Phase 3 program evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect.
Previous wording
We entered into an open market sales agreement (“Sales Agreement”) with Jefferies LLC (“Jefferies”), in 2021 pursuant to which we may from time to time offer and sell shares of our common stock for an aggregate offering price of up to $200.0 million, through or to Jefferies, acting as sales agent or principal. We have agreed to pay Jefferies a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Jefferies with customary indemnification and contribution rights. As of September 30, 2024, no shares have been issued under the Sales Agreement. The shares may be offered and sold under the Company’s shelf registration statement on Form S-3 and related prospectus filed with the SEC on November 24, 2021, as amended.
Current wording
We are party to an amended and restated open market sales agreement ("Sales Agreement") with Jefferies LLC ("Jefferies"), pursuant to which we may from time to time offer and sell shares of our common stock (“Common Stock”) for an aggregate offering price of up to $200.0 million, through or to Jefferies, acting as sales agent or principal. We have agreed to pay Jefferies a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Jefferies with customary indemnification and contribution rights. As of March 31, 2025, no shares have been issued under the Sales Agreement. Any shares will be offered and sold under the Company's shelf registration statement on Form S-3 declared effective by the SEC on November 19, 2024.
Previous wording
To date, we have not generated any product revenue. We do not expect to generate any product revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates and we do not know when, or if, this will occur. We expect to continue to incur significant operating expenditures for the foreseeable future as we continue the development of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Moreover, we expect to incur additional general and administrative costs as we continue to operate as a public company and expand our organization to support the initiation of activities in preparation for potential commercialization of our product candidates.
Current wording
To date, we have not generated any product revenue. We do not expect to generate any product revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates and we do not know when, or if, this will occur. We expect to continue to incur significant expenditures for the foreseeable future as we continue the development of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Moreover, we expect to incur additional general and administrative costs as we continue to operate as a public company and potentially expand our organization to support the initiation of activities in preparation for potential commercialization of our product candidates. Further, we expect to return $25.0 million to our stockholders as part of the Share Repurchase Program.
Previous wording
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. The failure of our COVID-19 Phase 3 SUNRISE-3 clinical trial to meet its primary endpoint may make this capital raising effort more difficult. We may seek to raise capital through public or private equity or debt financings, collaborative arrangements with third parties, or through other sources of financing. The additional capital that we will require will depend upon many factors, including:
Current wording
We will continue to invest significant capital to develop our product candidates and fund operations for the foreseeable future. To fund such investment, we may seek to raise capital through public or private equity or debt financings, collaborative arrangements with third parties, or through other sources of financing. We anticipate that we may need to raise substantial additional capital, the requirements for which will depend on many factors, including:
Previous wording
the scope, timing, rate of progress and costs of our drug discovery efforts, preclinical development activities, laboratory testing and clinical trials for our product candidates;
Current wording
the scope, timing, rate of progress and costs of our Phase 3 program evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV and our other drug discovery efforts, preclinical development activities, laboratory testing and clinical trials for other product candidates;
Previous wording
the scope and costs of development and commercial manufacturing activities;
Current wording
the scope and costs of development and commercial manufacturing activities which may be adversely impacted if tariffs are imposed on pharmaceutical products or the materials, including regulatory starting materials, necessary to manufacture our product candidates;
Previous wording
Market volatility, inflation, interest rate fluctuations, macroeconomic trends and geopolitical events, including civil or political unrest and terrorism, may have a significant impact on the availability of funding sources and the terms on which any funding may be available.
Current wording
Market volatility, inflation, interest rate fluctuations, tariffs, macroeconomic trends and geopolitical events, including civil or political unrest and terrorism, may have a significant impact on the availability of funding sources and the terms on which any funding may be available.
Previous wording
See Part II, Item 1A,“Risk Factors” in this Quarterly Report on Form 10-Q for additional risks associated with our substantial capital requirements.
Current wording
See Part II, Item 1A,“Risk Factors” for additional risks associated with our substantial capital requirements.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2023 was $63.6 million. Net cash used in operating activities was primarily due to net loss of $96.8 million, accretion of premium and discounts on marketable securities of $11.1 million and a net decrease in accounts payable of $2.1 million, partially offset by stock-based compensation expense of $37.3 million, a decrease in prepaid expenses of $6.0 million and an increase in accrued expenses of $2.9 million.
Current wording
Net cash used in operating activities for the three months ended March 31, 2025 was $30.6 million. Cash used in operating activities was primarily due to a net loss of $34.3 million, accretion of premium and discounts on marketable securities of $1.7 million, and an increase in other assets of $4.2 million, partially offset by stock-based compensation of $7.0 million and an increase in accounts payable and accrued expenses of $3.3 million.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $105.1 million. Cash used in operating activities was primarily due to a net loss of $134.8 million, a decrease in accrued expenses and other current liabilities of $8.4 million and an accretion of premium and discounts on marketable securities of $9.1 million, partially offset by a stock-based compensation expense of $37.5 million, a decrease in prepaid expenses and other current assets of $8.3 million and an increase in accounts payable of $1.5 million.
Current wording
Net cash used in operating activities for the three months ended March 31, 2024 was $39.9 million. Cash used in operating activities was primarily due to a net loss of $63.2 million and accretion of premium and discounts on marketable securities of $3.5 million, partially offset by a stock-based compensation of $12.6 million, an increase in accounts payable and accrued expenses of $9.1 million and a decrease in prepaid expenses and other current assets of $5.1 million.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2024 was $59.5 million and consisted of sales and maturities of marketable securities of $462.1 million offset by purchases of marketable securities of $402.7 million.
Current wording
Net cash provided by investing activities for the three months ended March 31, 2025 was $85.6 million and consisted of sales and maturities of marketable securities of $208.2 million partially offset by purchases of marketable securities of $122.6 million.
Previous wording
Cash provided by investing activities for the nine months ended September 30, 2023 was $12.5 million and consisted of sales and maturities of marketable securities of $527.7 million partially offset by purchases of marketable securities of $515.1 million.
Current wording
Net cash provided by investing activities for the three months ended March 31, 2024 was $56.8 million and consisted of sales and maturities of marketable securities of $224.0 million partially offset by purchases of marketable securities of $167.2 million.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $0.3 million and consisted of proceeds from the issuance of our common stock under our Employee Stock Purchase Plan (“ESPP”).
Current wording
Net cash used in financing activities for the three months ended March 31, 2025 was $0.3 million and consisted of net issuance of restricted stock units partially offset by proceeds from the issuance of our common stock under our Employee Stock Purchase Plan (“ESPP”).
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2023 was $0.3 million and consisted of proceeds from the issuance of our common stock under the ESPP.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2024 was $0.2 million and consisted of proceeds from the issuance of our common stock under our ESPP.
Previous wording
There have been no material changes to our contractual obligations during the three and nine months ended September 30, 2024 from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
There have been no material changes to our contractual obligations during the three months ended March 31, 2025 from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
We enter into contracts in the normal course of business with third-party contract organizations including CROs and CMOs for preclinical and clinical studies and testing, manufacture and supply of our preclinical materials and other services and products used for operating purposes. These contracts do not contain any minimum purchase commitments and generally provide for termination following a certain period after notice, and therefore we believe that our non-cancelable obligations under these agreements are not material. Payments due upon cancellation consist only of payments for services provided and expenses incurred up to the date of cancellation.
Current wording
We enter into contracts in the normal course of business with CROs for preclinical and clinical studies and testing, CMOs for manufacture and supply of our clinical trial materials and other third parties for other services and products used for operating purposes. These contracts do not contain any minimum purchase commitments and generally provide for termination following a certain period after notice, and therefore we believe that our non-cancelable obligations under these agreements are not material. Payments due upon cancelation principally consist only of payments for services provided and expenses incurred up to the date of cancelation.
Previous wording
Our unaudited condensed consolidated financial statements have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Current wording
Our financial statements have been prepared in accordance with US generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The effects of material revisions in estimates, if any, will be reflected in the consolidated financial statements prospectively from the date of change in estimates.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
We believe we are well capitalized to advance our current programs. We had $425.4 million in cash, cash equivalents and marketable securities at March 31, 2025.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the periods indicated:
Previous report — wording carried elsewhere
Interest income and other, net, decreased by $1.7 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023, primarily due to lower investment balances.
Previous report — wording carried elsewhere
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $482.8 million. Based upon our current operating plan, we believe that our available cash, cash equivalents and marketable securities will be sufficient to fund our planned operations through 2027.