Atea Pharmaceuticals, Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 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.
Jun 30, 2025 · Filed Aug 7, 2025
AVIR$4.31+2.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0000950170-25-105123
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 123 previous paragraphs and 123 current paragraphs.
81 unchanged; 30 reworded; 9 added; 12 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 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 (9)
Current report
Key Clinical Trial Results – Phase 2 and Phase 1
Current report
The Phase 2 study results were presented in May 2025 at the European Association for the Study of Liver (“EASL”) Congress 2025. Additionally, at EASL in May 2025, we presented results from three Phase 1 studies. These studies included a pharmacokinetic study, a drug-drug interaction study and a renal impairment study.
Current report
The results from the Phase 1 pharmacokinetic study, which evaluated a single 550 mg dose of bemnifosbuvir in healthy participants with varying degrees of hepatic impairment, support the administration of bemnifosbuvir without dose adjustment in patients with hepatic impairment. The results from the Phase 1 drug-drug interaction study in healthy participants showed that co-administration of bemnifosbuvir and ruzasvir with the standard HIV regimen bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF) resulted in no clinically significant pharmacokinetic changes. The results from the Phase 1 renal impairment study in healthy participants showed that a single 550 mg dose of bemnifosbuvir was well-tolerated across participants with normal kidney function, moderate-to-severe renal impairment, and those with end-stage renal disease on hemodialysis. These data suggest bemnifosbuvir may be administered without dose adjustment in patients with renal dysfunction, including those undergoing dialysis.
Current report
During the three months ended June 30, 2025 we repurchased 4,619,597 shares of our common stock for an aggregate price of approximately $14.1 million (including transaction costs). As of June 30, 2025, approximately $11.1 million remained authorized for future repurchases. Repurchased shares of our common stock were retired immediately upon receipt and returned to authorized and unissued status.
Current report
Research and development expenses decreased by $2.4 million from $34.7 million for the three months ended June 30, 2024 to $32.3 million for the three months ended June 30, 2025. The net decrease was primarily driven by substantially lower COVID-19 external spend as a result of our COVID-19 Phase 3 SUNRISE-3 clinical trial being completed in 2024 together with a decrease in internal research and development expenses primarily related to lower stock-based compensation and payroll related expenses in the three months ended June 30, 2025, offset by increased external spend related principally for our HCV Phase 3 clinical development program including the recognition of expense related to the milestone paid to Merck.
Current report
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report
General and administrative expenses decreased by $5.9 million from $24.5 million for the six months ended June 30, 2024 to $18.5 million for the six months ended June 30, 2025. The net decrease was primarily related to lower stock-based compensation expense, partially offset by increased professional fees.
Current report
Income tax expense was $0.4 million and $0.5 million for the six months ended June 30, 2025 and 2024, respectively.
Current report
In April 2025, our Board of Directors authorized us to repurchase an aggregate amount of $25.0 million of common stock. During the three months ended June 30, 2025, we repurchased 4,619,597 shares of common stock for an aggregate price of approximately $14.1 million (including transaction costs). As of June 30, 2025, approximately $11.1 million remained authorized for future common stock repurchases.
Removed paragraphs (12)
Previous 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.
Previous report
Key Clinical Trial Results
Previous 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.
Previous report
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 report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Interest Income and Other, Net
Previous report
Income Taxes
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Interest Income and Other, Net
Reworded paragraphs (30)
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. 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.
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. Currently, we are evaluating the regimen in a Phase 3 clinical development program which includes two Phase 3 clinical trials namely “C-Beyond” which is the clinical trial we are conducting in the United States (“US”) and Canada and “C-Forward” which is the clinical trial we are conducting outside of North America. Patient enrollment in C-Beyond and C-Forward began in April and June 2025, respectively, and is currently ongoing.
Previous wording
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 wording
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 US, Europe and Japan.
Previous wording
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 wording
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. It is estimated that HCV leads to 240,000 deaths per year. These deaths are primarily attributable to cirrhosis and hepatocellular cancer, each of which are serious long-term consequences resulting from prolonged exposure to HCV infection.
Previous wording
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 wording
The objective of our HCV development program, which is now enrolling patients in two Phase 3 clinical trials, 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, many of whom take medications for other conditions. 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.
Previous wording
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 wording
Presently, there are no short-course (i.e., eight 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.
Previous wording
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 wording
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. The Phase 3 trial being conducted in the US and Canada is referred to as C-Beyond and the Phase 3 clinical trial being conducted outside of North America is referred to as C-Forward.
Previous wording
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 wording
Each of C-Beyond and C-Forward is expected to enroll approximately 880 treatment-naïve patients, both with and without compensated cirrhosis. Patients are being stratified by genotype and cirrhosis status, and patients with human immunodeficiency virus (“HIV”) co-infection may be enrolled. For non-cirrhotic patients, eight 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 global geographic footprint of the Phase 3 program is to assist us in enrolling patients with varied HCV genotypes.
Previous wording
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 wording
Primary efficacy endpoint results showed a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after eight 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.
Previous 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.
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 eight 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
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.
Current wording
We believe we are well capitalized to advance our current programs. We had $379.7 million in cash, cash equivalents and marketable securities at June 30, 2025.
Previous wording
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 wording
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 the 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.
Previous wording
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 wording
As previously announced, in December 2024, we engaged Evercore LLC, a global independent investment bank, to assist us in the identification of additional opportunities to enhance stockholder value. This 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. As a part of this process, 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.
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 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.
Current wording
In addition to a non-refundable upfront payment that we made in February 2022, we are 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 recognized this 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
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 wording
As of June 30, 2025, we had cash, cash equivalents and marketable securities of $379.7 million. Net cash used in operating activities was $63.4 million for the six months ended June 30, 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, 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.
Previous 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.
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 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 activities to identify within our compound library other potential product candidates for the treatment of diseases caused by single stranded RNA viruses;
Current wording
continue discovery and IND-enabling activities to identify other potential product candidates for the treatment of diseases caused by single stranded RNA viruses;
Previous wording
initiate clinical development of a protease inhibitor for the treatment of respiratory and other diseases resulting from infection with single stranded RNA viruses;
Current wording
initiate clinical development of product candidates for the treatment of respiratory and other diseases resulting from infection with single stranded RNA viruses;
Previous 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.
Current wording
General and administrative expenses decreased by $3.2 million from $12.2 million for the three months ended June 30, 2024 to $9.1 million for the three months ended June 30, 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 $1.9 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024, primarily due to lower investment balances.
Current wording
Interest income and other, net, decreased by $2.2 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024, primarily due to lower investment balances.
Previous 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.
Current wording
Research and development expenses decreased by $30.4 million from $92.3 million for the six months ended June 30, 2024 to $61.9 million for the six months ended June 30, 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 for our HCV Phase 3 clinical development including the purchase of comparator drug and expense related to the Merck milestone. Additionally, a decrease in internal research and development expenses was primarily related to lower stock-based compensation expense in the six months ended June 30, 2025.
Previous 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.
Current wording
As of June 30, 2025, we had cash, cash equivalents and marketable securities of $379.7 million. We believe that our available cash, cash equivalents and marketable securities will be sufficient to fund the remaining portion of the 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 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.
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 June 30, 2025, no shares have been issued under the Sales
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 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.
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.
Previous 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.
Current wording
Net cash used in operating activities for the six months ended June 30, 2025 was $63.4 million. Cash used in operating activities was primarily due to a net loss of $71.4 million, accretion of premium and discounts on marketable securities of $3.1 million, and an increase in other assets of $4.2 million, partially offset by stock-based compensation of $11.6 million, an increase in accounts payable and accrued expenses of $1.8 million and a decrease in prepaid expenses and other current assets of $1.7 million.
Previous 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.
Current wording
Net cash used in operating activities for the six months ended June 30, 2024 was $82.1 million. Cash used in operating activities was primarily due to a net loss of $103.7 million, a decrease in accrued expenses and other current liabilities of $6.7 million and accretion of premium and discounts on marketable securities of $6.5 million, partially offset by stock-based compensation expense of $25.3 million, a decrease in prepaid expenses and other current assets of $8.2 million and an increase in accounts payable of $1.2 million.
Previous 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.
Current wording
Net cash provided by investing activities for the six months ended June 30, 2025 was $100.9 million and consisted of sales and maturities of marketable securities of $324.3 million partially offset by purchases of marketable securities of $223.4 million.
Previous 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.
Current wording
Net cash provided by investing activities for the six months ended June 30, 2024 was $181.5 million and consisted of sales and maturities of marketable securities of $356.0 million partially offset by purchases of marketable securities of $174.5 million.
Previous 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”).
Current wording
Net cash used in financing activities for the six months ended June 30, 2025 was $14.4 million and consisted of stock repurchases of $14.1 million and net issuance of restricted stock units of $0.5 million, partially offset by proceeds from the issuance of our common stock under our Employee Stock Purchase Plan (“ESPP”) of $0.1 million.
Previous 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.
Current wording
Net cash provided by financing activities for the six months ended June 30, 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 months ended March 31, 2025 from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
There have been no material changes to our contractual obligations during the three and six months ended June 30, 2025 from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the periods indicated:
Current report — wording carried from elsewhere
Interest income and other, net, decreased by $4.1 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024, primarily due to lower investment balances.
Current report — wording carried from elsewhere
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.