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Atea Pharmaceuticals, Inc.

For the period ended Sep 30, 2026. Filed Nov 9, 2026.

View on SEC.gov

About this filing

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.

Sep 30, 2026 · Filed Nov 9, 2026

AVIR$4.41+2.3%Stored close · as of Nov 9, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-12.

0001193125-26-347021

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-09.

0001193125-26-453807

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 122 previous paragraphs and 130 current paragraphs.

81 unchanged; 38 reworded; 9 added; 3 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 4 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

In July 2026, we initiated clinical development of AT-587 in a Phase 1 clinical trial which is designed to evaluate the safety, tolerability and pharmacokinetics of AT-587 in healthy volunteers. The single ascending dose phase of this study has been completed and we are now conducting the study’s multiple ascending dose phase. As development advances in the Phase 1 clinical trial, we are also preparing for the initiation of a potential proof-of-concept study of AT-587 in 2027.

Current report

General and administrative expenses decreased by $0.3 million from $7.2 million for the three months ended September 30, 2025 to $6.9 million for the three months ended September 30, 2026. The net decrease was primarily related to lower stock-based compensation expense.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025

Current report

On November 6, 2026 (the “Closing Date”), we entered into the Loan and Security Agreement with Hercules Capital, Inc., as agent, and the lenders party thereto, providing for term loans in an aggregate principal amount of up to $200.0 million, subject to the terms and conditions set forth therein.

Current report

The Loan and Security Agreement provides for senior secured term loans which mature on November 1, 2031 (the “Maturity Date”), for up to $200.0 million and consists of the following tranches (collectively, the “Term Loans”): (1) a Tranche 1 Term Loan of $65.0 million drawn on the Closing Date, (2) a Tranche 2 Term Loan of up to $35.0 million, (3) a Tranche 3 Term Loan up to the difference between $35.0 million and the amounts funded under Tranche 4, (4) a Tranche 4 Term Loan up to the difference between $70.0 million and the amounts funded under Tranche 3, and (5) a Tranche 5 Term Loan of up to $30.0 million. The Tranche 2 Term Loan is available subject to certain conditions, including the successful completion, prior to a specified date in the second half of 2027, of the Company’s ongoing Phase 3 clinical trial, which is evaluating BEM/RZR for the treatment of hepatitis C virus infection. The Tranche 3 and Tranche 4 Term Loans are available subject to certain conditions, including the achievement of a financing milestone and certain milestones relating to the development and commercialization of BEM/RZR by specified dates. The Tranche 5 Term Loan is available in the sole discretion of the lenders.

Current report

All Term Loans will bear interest at a floating rate based upon an annual interest rate of the greater of (i) the prime rate as reported in The Wall Street Journal plus 2.35% and (ii) 9.35%, payable monthly in arrears. The Company is required to pay an initial upfront fee of $0.65 million and an upfront fee equal to 1.00% of any advance for Tranche 2 through Tranche 5. The Term Loans are interest-only for 48 months, extendable to maturity upon achievement of a commercial milestone. The Company may prepay the Term Loans in whole or in part prior to the maturity date, subject to certain prepayment fees. Upon any prepayment of the Term Loans, at maturity or upon acceleration, the Company is also required to pay an end of term charge.

Current report

The Loan and Security Agreement contains customary affirmative and restrictive covenants, representations and warranties and events of default. The Loan and Security Agreement contains financial covenants, including: (i) a minimum cash covenant, which is tested beginning on October 1, 2027, requiring the Company to maintain cash at all times in an amount greater than or equal to a specified percentage of the outstanding obligations under the Loan and Security Agreement; provided that the minimum cash covenant is not tested on any day when the Company meets a specified market capitalization requirement and (ii) a performance covenant that is tested beginning on the last day of the month that is six months after FDA approval of BEM/RZR, requiring the Company to meet specified minimum revenues from sales of BEM/RZR, or alternatively, meet a minimum cash covenant requiring the Company to maintain cash in an amount equal to at least 50% of outstanding obligations under the Loan and Security Agreement in addition to meeting a specified market capitalization requirement or maintain cash in an amount of at least 85% of outstanding obligations under the Loan and Security Agreement. Upon the occurrence of an event of default, the lenders may, among other things, accelerate the Company’s obligations under the Loan and Security Agreement (including all obligations for principal, interest and any applicable prepayment charges and end of term charges); provided that upon an event of default relating to certain insolvency, liquidation, bankruptcy or similar events, all outstanding obligations will be automatically accelerated.

Current report

The Company’s obligations under the Loan and Security Agreement are secured by substantially all of its assets, including its intellectual property. Certain of the Company’s future subsidiaries may, from time to time after the Closing Date, join as co-borrowers or guarantors and be required to guarantee the Company’s obligations under the Loan and Security Agreement and, in connection with such guarantee, pledge substantially all of their assets, including intellectual property, to secure such guarantee.
Removed paragraphs (3)

Previous report

complete the Phase 3 clinical development of the regimen of BEM/RZR for the treatment of HCV;

Previous report

General and administrative expenses decreased by $4.7 million from $18.5 million for the six months ended June 30, 2025 to $13.8 million for the six months ended June 30, 2026. The net decrease was primarily related to lower salaries and wages, lower stock-based compensation expense and lower professional fees.
Reworded paragraphs (38)

Previous wording

We are a late-stage clinical biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biochemistry and virology to discover, develop and commercialize novel, orally administered antivirals to treat serious viral diseases. Our current product candidate pipeline includes the regimen of bemnifosbuvir and ruzasvir (“BEM/RZR”) which we believe has the potential to improve the current standard of care (“SOC”) for the treatment of patients with hepatitis C virus (“HCV”) infection and AT-587 which we believe has the potential to be the first direct-acting antiviral (“DAA”) for the treatment of patients, particularly immunocompromised patients, with chronic hepatitis E virus (“HEV”) infection.

Current wording

We are a late-stage clinical biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biochemistry and virology to discover, develop and commercialize novel, orally administered antivirals to treat serious viral diseases. Our current product candidate pipeline includes the fixed-dose combination (“FDC”) regimen of bemnifosbuvir and ruzasvir (“BEM/RZR”) which we believe has the potential to improve the current standard of care (“SOC”) for the treatment of patients with hepatitis C virus (“HCV”) infection and AT-587 which we believe has the potential to be the first direct-acting antiviral (“DAA”) for the treatment of patients, particularly immunocompromised patients, with chronic hepatitis E virus (“HEV”) infection.

Previous wording

The objective of our HCV development program is to improve upon the current SOC by offering the fixed-dose combination (“FDC”) regimen of BEM/RZR as a differentiated pan-genotypic protease inhibitor-free, short-duration regimen with a low risk of drug-drug interactions for patients infected with HCV, if successfully developed and approved. We believe that a novel, shorter duration, easily prescribable treatment will benefit today’s HCV patient population, which is predominately young (20-49 years old) and non-cirrhotic (80-90% of the US population), and would be a significant improvement to the current SOC.

Current wording

The objective of our HCV development program is to improve upon the current SOC by offering BEM/RZR as a differentiated pan-genotypic protease inhibitor-free, short-duration regimen with a low risk of drug-drug interactions for patients infected with HCV, if successfully developed and approved. We believe that a novel, shorter duration, easily prescribable treatment will benefit today’s HCV patient population, which is predominantly young (20-49 years old) and non-cirrhotic (80-90% of the US population), and would be a significant improvement to the current SOC.

Previous wording

Presently, there are no short-course (i.e., eight week) nucleotide inhibitor-based, pan-genotypic HCV treatment regimens. Clinical and nonclinical results from studies we conducted prior to our Phase 3 program have shown that the BEM/RZR regimen has high antiviral potency and has been well tolerated. These studies have also shown that the BEM/RZR regimen has a low risk for drug-drug interactions with many commonly prescribed medications including proton pump inhibitors and offers the convenience of being able to be taken with or without food. This is a profile that we believe will offer a significant improvement to the current SOC, if approved.

Current wording

Presently, there are no short-course (i.e., eight week) nucleotide inhibitor-based, pan-genotypic HCV treatment regimens. Clinical and nonclinical results from studies we conducted prior to our Phase 3 program have shown that BEM/RZR has high antiviral potency and has been well tolerated. These studies have also shown that BEM/RZR has a low risk for drug-drug interactions with many commonly prescribed medications including proton pump inhibitors and offers the convenience of being able to be taken with or without food. This is a profile that we believe will offer a significant improvement to the current SOC, if approved.

Previous wording

In June 2026, we announced that we completed enrollment of more than 880 HCV patients in C-FORWARD. Currently, we anticipate to report the topline results from C-FORWARD early in the first quarter of 2027. Pending successful results from C-FORWARD, we are targeting submission to the U.S. Food and Drug Administration (“FDA”) of a New Drug Application (“NDA”) for marketing approval in the second quarter of 2027.

Current wording

In June 2026, we announced that we completed enrollment of more than 880 HCV patients in C-FORWARD. Currently, we anticipate to report the topline results from C-FORWARD in the first quarter of 2027. Pending successful results from C-FORWARD, we are targeting submission to the U.S. Food and Drug Administration (“FDA”) of a New Drug Application (“NDA”) for marketing approval in the second quarter of 2027.

Previous wording

AT-587 has demonstrated potent nanomolar antiviral activity against HEVin vitro. In single-dosein vivo nonclinical pharmacokinetic studies, high plasma concentrations of the surrogate to the active intracellular triphosphate metabolite were observed in all animal species tested. Results fromin vitro toxicology, pharmacology and drug metabolism and pharmacokinetic studies indicate the potential for a favorable clinical profile for AT-587. In July 2026, we initiated clinical development of AT-587 in a Phase 1 clinical trial which is designed to evaluate the safety, tolerability and pharmacokinetics of AT-587 in healthy volunteers.

Current wording

AT-587 has demonstrated potent nanomolar antiviral activity against HEVin vitro. In single-dosein vivo nonclinical pharmacokinetic studies, high plasma concentrations of the surrogate to the active intracellular triphosphate metabolite were observed in all animal species tested. Results fromin vitro toxicology, pharmacology and drug metabolism and pharmacokinetic studies indicate the potential for a favorable clinical profile for AT-587.

Previous wording

We believe we are well capitalized to advance our current programs. We had $219.5 million in cash, cash equivalents and marketable securities at June 30, 2026.

Current wording

We believe we are well capitalized to advance our current programs. We had $191.2 million in cash, cash equivalents and marketable securities at September 30, 2026. In November 2026, we entered into a loan and security agreement (“Loan and Security Agreement”) with Hercules Capital, Inc. (“Hercules”) providing for up to $200.0 million in term loans. On the closing date, we had access to and borrowed $65.0 million under the Loan and Security Agreement. For additional information, see “Liquidity and Capital Resources” below.

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. 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, additional term loans under the Loan and Security Agreement (to the extent we meet the required conditions for remaining tranches), other debt financings, collaborative or other arrangements with third parties, or through other sources of financing. 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

Additionally, in April 2025, our Board authorized a program to repurchase shares of our common stock (“Common Stock”). Under this authorization, we returned capital to our stockholders while maintaining the capacity to complete the Phase 3 clinical development of the regimen of BEM/RZR and execute on our other strategic business plans. Under the share repurchase program, which was fully completed in 2025, we expended $25.5 million (including transaction costs and excise taxes) in connection with the repurchase of 7,673,792 shares of our Common Stock.

Current wording

Additionally, in April 2025, our Board authorized a program to repurchase shares of our common stock (“Common Stock”). Under this authorization, we returned capital to our stockholders while maintaining the capacity to complete the Phase 3 clinical development of BEM/RZR and execute on our other strategic business plans. Under the share repurchase program, which was fully completed in 2025, we expended $25.5 million (including transaction costs and excise taxes) in connection with the repurchase of 7,673,792 shares of our Common Stock.

Previous wording

In addition to a non-refundable upfront payment that we made in February 2022, we agreed 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 in April 2025 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 BEM/RZR for the treatment of HCV. 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. If we successfully complete C-FORWARD, our Phase 3 clinical trial, and our HCV development program evaluating the BEM/RZR regimen, and we are able to complete and submit the NDA to the FDA on our current projected timeline, we anticipate that this next potential milestone may become due and payable during the three months ending September 30, 2027.

Current wording

In addition to a non-refundable upfront payment that we made in February 2022, we agreed 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 in April 2025 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 BEM/RZR for the treatment of HCV. 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. If we successfully complete C-FORWARD, our Phase 3 clinical trial, and our HCV development program evaluating BEM/RZR, and we are able to complete and submit the NDA to the FDA on our current projected timeline, we anticipate that this next potential milestone may become due and payable during the three months ending September 30, 2027.

Previous wording

As of June 30, 2026, we had cash and investments of $219.5 million. Net cash used in operating activities was $83.5 million for the six months ended June 30, 2026.

Current wording

As of September 30, 2026, we had cash and investments of $191.2 million. Net cash used in operating activities was $112.3 million for the nine months ended September 30, 2026. In November 2026, upon entry into the Loan and Security Agreement, we had access to and borrowed an initial tranche of $65.0 million.

Previous wording

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, prepare and submit an application for marketing approval of the regimen of BEM/RZR, engage in pre-launch activities and advance AT-587 for the treatment of HEV to late-stage clinical development.

Current wording

Based on our current plans, we anticipate our existing financial resources, including the initial borrowing of $65.0 million that we have drawn under the Loan and Security Agreement, will allow us to complete clinical Phase 3 development, prepare and submit an application to the FDA for marketing approval, engage in pre-launch activities, and if approved, initiate commercialization of BEM/RZR and to advance AT-587 for the treatment of HEV to late-stage clinical development.

Previous wording

We expect that our net cash used in operating activities will remain significant as we complete the clinical development of the regimen of BEM/RZR for the treatment of HCV, seek regulatory approval, manufacture such product at commercial scale and prepare for and, if approved, pursue commercialization activities; advance AT-587, our HEV product candidate through clinical development; 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.

Current wording

We expect that our net cash used in operating activities will remain significant as we complete the clinical development of BEM/RZR for the treatment of HCV, seek regulatory approval (which among other things requires the manufacture of such product at commercial scale) and prepare for and, if approved, pursue commercialization activities; advance AT-587, our HEV product candidate through clinical development; 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, including the $65.0 million that we have drawn under the Loan and Security Agreement, cash equivalents and marketable securities will be sufficient to fund our planned operations into mid-2028. 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 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. 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, additional term loans under the Loan and Security Agreement (to the extent we meet the required conditions for remaining tranches), other debt financings, collaborative or other arrangements with third parties, or through other sources of financing. 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

complete non-clinical NDA enabling activities including those associated with the manufacture of the regimen of BEM/RZR at commercial scale;

Current wording

complete non-clinical NDA enabling activities including those associated with the manufacture of BEM/RZR at commercial scale;

Previous wording

seek marketing approval and prepare for potential commercialization of the regimen of BEM/RZR for the treatment of HCV;

Current wording

seek marketing approval and prepare for potential commercialization of BEM/RZR for the treatment of HCV;

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

To the extent that we expand our organization or otherwise engage in increased activities associated with commercialization, including pre-launch activities prior to approval, we anticipate that our general and administrative expenses will increase. Additionally, our general and administrative expenses may increase, as a result of other increased personnel costs, other infrastructure expansions, increased consulting, legal and accounting services, costs associated with complying with Nasdaq and SEC requirements and increased investor relations costs.

Previous wording

Research and development expenses decreased by $4.1 million from $32.3 million for the three months ended June 30, 2025 to $28.2 million for the three months ended June 30, 2026. The net decrease was primarily driven by a decrease in external spend for our HCV Phase 3 clinical development offset by an increase in external spend for HEV preclinical development and clinical development startup activities. The decrease in HCV Phase 3 clinical development external spend was principally the result of the completion of the Week 24 post treatment visits by patients in our C-BEYOND Phase 3 clinical trial. The decrease in internal research and development expenses was primarily related to lower stock-based compensation expense in the three months ended June 30, 2026.

Current wording

Research and development expenses decreased by $11.3 million from $38.3 million for the three months ended September 30, 2025 to $27.1 million for the three months ended September 30, 2026. The net decrease was primarily driven by a decrease in external spend for our HCV Phase 3 clinical development offset by an increase in external spend for HEV preclinical and clinical development activities. In addition, we had lower internal research and development expenses primarily related to lower stock-based compensation expense in the three months ended September 30, 2026.

Previous wording

Interest income and other, net, decreased by $2.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily due to lower investment balances.

Current wording

Interest income and other, net, decreased by $1.8 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily due to lower investment balances.

Previous wording

Research and development expenses increased by $7.4 million from $61.9 million for the six months ended June 30, 2025 to $69.3 million for the six months ended June 30, 2026. The net increase was primarily driven by an increase in external spend for our HCV Phase 3 clinical development and an increase in HEV preclinical development activities and initiation of HEV clinical development startup activities. The increase in external HCV Phase 3 clinical development expense was principally the result of the conduct of both C-BEYOND and C-FORWARD Phase 3 clinical trials in the six months ended June 30, 2026. The increase in external spend was partially offset by lower internal research and development expenses primarily related to lower salaries and wages and lower stock-based compensation expense in the six months ended June 30, 2026.

Current wording

Research and development expenses decreased by $3.8 million from $100.2 million for the nine months ended September 30, 2025 to $96.4 million for the nine months ended September 30, 2026. The net decrease was primarily driven by a decrease in external spend for our HCV Phase 3 clinical development offset by an increase in external spend for HEV preclinical and clinical development activities. In addition, we had lower internal research and development expenses primarily related to lower salaries and wages and lower stock-based compensation expense in the nine months ended September 30, 2026.

Previous wording

General and administrative expenses decreased by $2.1 million from $9.1 million for the three months ended June 30, 2025 to $7.0 million for the three months ended June 30, 2026. The net decrease was primarily related to lower stock-based compensation expense and lower professional fees.

Current wording

General and administrative expenses decreased by $5.0 million from $25.7 million for the nine months ended September 30, 2025 to $20.7 million for the nine months ended September 30, 2026. The net decrease was primarily related to lower stock-based compensation expense and lower professional fees.

Previous wording

Interest income and other, net, decreased by $4.6 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily due to lower investment balances.

Current wording

Interest income and other, net, decreased by $6.4 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, primarily due to lower investment balances.

Previous wording

Income tax expense was $0.1 and $0.4 million for the six months ended June 30, 2026 and 2025, respectively.

Current wording

Income tax expense was $0.1 and $0.6 million for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

As of June 30, 2026, we had cash, cash equivalents and marketable securities of $219.5 million. We believe that our available cash and investments will be sufficient to fund our planned operations through 2027 including the completion of the Phase 3 program evaluating the regimen of BEM/RZR 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 September 30, 2026, we had cash, cash equivalents and marketable securities of $191.2 million. We believe that our available cash and investments, inclusive of the $65.0 million we have drawn under the Loan and Security Agreement will be sufficient to fund our planned operations into mid-2028 including the completion of the Phase 3 program evaluating BEM/RZR 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

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 prepare for 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, including selling costs, as we continue to operate as a public company and potentially expand our organization to support and otherwise initiate additional activities in preparation for potential commercialization of the regimen of BEM/RZR.

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 prepare for 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, including selling costs, as we continue to operate as a public company and potentially expand our organization to support and otherwise initiate additional activities in preparation for potential commercialization of BEM/RZR.

Previous 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:

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, additional term loans under the Loan and Security Agreement (to the extent we meet the required conditions for remaining tranches), or other 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 and terms of strategic collaborations we enter into to strengthen our capabilities to commercialize the regimen of BEM/RZR, if approved;

Current wording

the scope and terms of strategic collaborations we enter into to strengthen our capabilities to commercialize BEM/RZR, if approved;

Previous wording

the cost, timing and outcome of preparing for and undergoing regulatory review of our regimen of BEM/RZR for the treatment of HCV and any other product candidates;

Current wording

the cost, timing and outcome of preparing for and undergoing regulatory review of BEM/RZR for the treatment of HCV and any other product candidates;

Previous wording

the cost and timing associated with commercializing regimen of BEM/RZR for the treatment of HCV and any other product candidates, if they receive marketing approval;

Current wording

the cost and timing associated with commercializing BEM/RZR for the treatment of HCV and any other product candidates, if they receive marketing approval;

Previous wording

A change in the outcome of any of these or other variables with respect to any of our product candidates could significantly change the costs and timing associated with the development or potential commercialization of one or more of our product candidates. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing that we enter into may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our Common Stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.

Current wording

A change in the outcome of any of these or other variables with respect to any of our product candidates could significantly change the costs and timing associated with the development or potential commercialization of one or more of our product candidates. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. The Loan and Security Agreement contains covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any future debt financing may impose additional covenants and restrictions on us. Any future debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 was $83.5 million. Cash used in operating activities was primarily due to a net loss of $78.4 million, accretion of premium and discounts on marketable securities of $1.1 million, a decrease in accounts payable and accrued expenses and other liabilities of $11.3 million, partially offset by stock-based compensation expense of $7.1 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 was $112.3 million. Cash used in operating activities was primarily due to a net loss of $110.5 million, accretion of premium and discounts on marketable securities of $1.5 million, a decrease in accounts payable and accrued expenses and other liabilities of $14.1 million, partially offset by decrease in prepaid and other assets of $3.1 million and stock-based compensation expense of $10.5 million.

Previous 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.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $103.8 million. Cash used in operating activities was primarily due to a net loss of $113.5 million, accretion of premium and discounts on marketable securities of $4.1 million, increase in prepaid expenses and other assets of $4.5 million,

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2026 was $64.1 million and consisted of sales and maturities of marketable securities of $172.4 million partially offset by purchases of marketable securities of $108.4 million.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2026 was $114.1 million and consisted of sales and maturities of marketable securities of $234.4 million partially offset by purchases of marketable securities of $120.3 million.

Previous 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.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2025 was $142.2 million and consisted of sales and maturities of marketable securities of $380.3 million partially offset by purchases of marketable securities of $238.1 million.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $0.3 million and consisted of $0.9 million in proceeds from the exercise of stock options and $0.1 million in proceeds from the issuance of our Common Stock under our employee stock purchase plan (“ESPP”) offset by $0.7 million used in connection with the net settlement of vested restricted stock units.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 was $0.5 million and consisted of $1.0 million in proceeds from the exercise of stock options and $0.2 million in proceeds from the issuance of our Common Stock under our employee stock purchase plan (“ESPP”) offset by $0.7 million used in connection with the net settlement of vested restricted stock units.

Previous 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 ESPP of $0.1 million.

Current wording

Net cash used in financing activities for the nine months ended September 30, 2025 was $25.7 million and consisted of stock repurchases of $25.5 million (including transaction costs and excise taxes) and $0.5 million used in connection with the net settlement of vested restricted stock units, partially offset by $0.3 million in proceeds from the issuance of our Common Stock under our ESPP and upon exercises of stock options.

Previous wording

There have been no material changes to our contractual obligations during the six months ended June 30, 2026 from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

During the nine months ended September 30, 2026, there were no material changes to our contractual obligations from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. In November 2026, we entered into the Loan and Security Agreement. For additional information, see “Liquidity and Capital Resources” above.

Previous 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.

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 otherwise as necessary to meet requirements for the submission of NDAs and other applications for marketing approval, 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 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.

Current wording

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 accrued research and development expenses and stock-based compensation.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

complete the Phase 3 clinical development of BEM/RZR for the treatment of HCV;

Current report — wording carried from elsewhere

partially offset by stock-based compensation of $16.1 million and an increase in accounts payable and accrued expenses of $2.0 million.