Atea Pharmaceuticals Inc

Previous wording

Currently, we are conducting SUNRISE-3, a global multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC) in high risk outpatients with mild to moderate COVID-19. In March 2024, we completed enrollment of patients in this study. The SUNRISE-3 patient population consists of those aged ≥70 years (regardless of other risk factors), individuals aged ≥55 years with one or more risk factors, those aged ≥50 years with two or more risk factors, and individuals aged ≥18 years with specific risk factors, including immunocompromised conditions, irrespective of COVID-19 vaccination status. Patients were randomized 1:1 to receive bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days.

Current wording

Currently, we are in the process of completing SUNRISE-3, a global Phase 3 clinical trial evaluating bemnifosbuvir for the treatment of Coronavirus disease 2019 (“COVID-19”). All patients in the SUNRISE-3 clinical trial, which is fully enrolled with 2,295 patients, have completed their last scheduled study visit. We are preparing for the analysis of the clinical trial data and subsequent reporting of the trial results. SUNRISE-3 is a global multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (“SOC”) in high-risk outpatients with mild to moderate COVID-19. In March 2024, we completed enrollment of patients in this study. The SUNRISE-3 patient population consists of those aged ≥70 years (regardless of other risk factors), individuals aged ≥55 years with one or more risk factors, those aged ≥50 years with two or more risk factors, and individuals aged ≥18 years with specific risk factors, including immunocompromised conditions, irrespective of COVID-19 vaccination status. Patients were randomized 1:1 to receive bemnifosbuvir 550 mg twice-daily (“BID”) or placebo BID for five days.

Previous wording

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 for HCV-infected patients with or without cirrhosis.

Current wording

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 wording

Currently, we are conducting a global Phase 2 clinical trial of bemnifosbuvir in combination with ruzasvir in treatment-naïve, HCV-infected patients either without cirrhosis or with compensated 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. Up to approximately 280 HCV-infected, treatment-naïve patients across HCV GTs, including a lead-in cohort of 60 patients without cirrhosis, are expected to be enrolled in this Phase 2 clinical trial. The primary endpoints of the study are safety and SVR12. Other virologic endpoints include virologic failure, SVR24 and resistance.

Current 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”). Other virologic endpoints include virologic failure, SVR at week 24 post-treatment and resistance.

Previous wording

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 the second half of 2024.

Current wording

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 the fourth quarter of 2024.

Previous wording

We believe we are well capitalized to advance our current programs. We had $541.5 million in cash, cash equivalents and marketable securities at March 31, 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 our COVID-19 SUNRISE 3 clinical trial and the completion of clinical development of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV and to fund our activities into 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 believe we are well capitalized to advance our current programs. We had $502.2 million in cash, cash equivalents and marketable securities at June 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 our COVID-19 SUNRISE 3 clinical trial and the completion of clinical development of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV and to fund our activities into 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

As of March 31, 2024, we had cash, cash equivalents and marketable securities of $541.5 million. Net cash used in operating activities was $39.9 million for the three months ended March 31, 2024.

Current wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $502.2 million. Net cash used in operating activities was $82.1 million for the six months ended June 30, 2024.

Previous wording

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 March 31, 2024 and 2023, we recorded a net reduction to research and development expenses of $1.3 million and $1.0 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.

Current wording

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 June 30, 2024 and 2023, we recorded a net reduction to research and development expenses of $0 million and $7.9 million, respectively, related to credits received from Roche. During the six months ended June 30, 2024 and 2023, we recorded a net reduction to research and development expenses of $1.3 million and $8.9 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 wording

Research and development expenses increased by $28.6 million from $29.0 million for the three months ended March 31, 2023 to $57.6 million for the three months ended March 31, 2024. The increase was primarily driven by higher external spend related to our Phase 3 COVID-19 SUNRISE-3 clinical trial and our Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV. This increase was partially offset by a reduction of $1.0 million in internal costs primarily due to a decrease in consulting and other research and development expenses.

Current wording

Research and development expenses increased by $12.6 million from $22.1 million for the three months ended June 30, 2023 to $34.7 million for the three months ended June 30, 2024. The increase was primarily driven by higher external spend related to our Phase 3 COVID-19 SUNRISE-3 clinical trial and our Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV. This increase was partially offset by a reduction of approximately $1.0 million in internal costs primarily due to a decrease in consulting and other research and development expenses.

Previous wording

General and administrative expenses decreased by $0.4 million from $12.6 million for the three months ended March 31, 2023 to $12.2 million for the three months ended March 31, 2024. The net decrease was primarily related to lower professional fees.

Current wording

General and administrative expenses decreased by $1.0 million from $13.2 million for the three months ended June 30, 2023 to $12.2 million for the three months ended June 30, 2024. The net decrease was primarily related to lower professional fees.

Previous wording

Interest income and other, net, increased by $0.6 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023, primarily due to investing in higher yield marketable securities and higher interest rates.

Current wording

Interest income and other, net, decreased by $0.7 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023, primarily due to lower investment balances.

Previous wording

As of March 31, 2024, we had cash, cash equivalents and marketable securities of $541.5 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 into 2027.

Current wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $502.2 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 into 2027.

Previous wording

See Part I, Item 1A,“Risk Factors” for additional risks associated with our substantial capital requirements.

Current 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.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2023 was $29.9 million. Cash used in operating activities was primarily due to net loss of $35.5 million, accretion of premium and discounts on marketable securities of $3.1 million and a decrease in accounts payable and accrued expenses of $6.0 million, partially offset by stock-based compensation of $12.5 million and a decrease in prepaid expenses of $2.3 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 an accretion of premium and discounts on marketable securities of $6.5 million, partially offset by a 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 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, 2023 was $46.0 million. Net cash used in operating activities was primarily due to net loss of $63.7 million, an accretion of premium and discounts on marketable securities of $6.8 million and a net decrease in accounts payable and accrued expenses of $2.1 million, partially offset by stock-based compensation expense of $24.9 million and a decrease in prepaid expenses and other current assets of $1.4 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 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 offset by purchases of marketable securities of $174.5 million.

Previous wording

Cash provided by investing activities for the three months ended March 31, 2023 was $24.5 million and consisted of sales and maturities of marketable securities of $181.1 million partially offset by purchases of marketable securities of $156.6 million.

Current wording

Cash provided by investing activities for the six months ended June 30, 2023 was $71.0 million and consisted of sales and maturities of marketable securities of $380.9 million partially offset by purchases of marketable securities of $309.8 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 Employee Stock Purchase Plan (“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 Employee Stock Purchase Plan (“ESPP”).

Previous wording

Net cash provided by financing activities was $0.2 million for the three months ended March 31, 2023 and consisted of proceeds from the shares sold under our ESPP.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2023 was $0.2 million and consisted of proceeds from the shares sold under the Company's ESPP.

Previous wording

There have been no material changes to our contractual obligations during the three months ended March 31, 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 and six months ended June 30, 2024 from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.

Previous wording

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 months ended March 31, 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.

Current wording

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 six months ended June 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.