Atea Pharmaceuticals Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout 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, 2024 · Filed Nov 7, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0000950170-24-092914
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0000950170-24-123447
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of 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 114 previous paragraphs and 111 current paragraphs.
72 unchanged; 35 reworded; 4 added; 7 removed; 0 previous and 0 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 (4)
Current report
In September 2024 we announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir versus placebo for the treatment of COVID-19. The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19. We believe that the unfavorable results from this study were impacted by the constantly evolving variants of COVID-19 and rapidly changing natural history of the disease, which has trended toward a milder disease where it makes it difficult to demonstrate the impact of a direct acting antiviral. This has led us to discontinue efforts to develop bemnifosbuvir for the treatment of COVID-19. In SUNRISE-3, bemnifosbuvir was generally safe and well tolerated. Currently, we continue to wind down and close out the study.
Current report
Other
Current report
Separately, we are engaging in efforts to discover a potential protease inhibitor product candidate for the treatment of respiratory and other diseases resulting from infection with single stranded RNA viruses. Our efforts in this regard remain at early stages and no clinical candidate has yet to be nominated.
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Removed paragraphs (7)
Previous report
As COVID-19 continues to persist as a global endemic disease with variant fueled surges of infection, oral antivirals protecting against the development of severe infection and transmission remain urgently needed particularly for high-risk patients who currently have few or no treatment options due to the limitations of currently available vaccines and therapeutics. High-risk patients include those who are unvaccinated, patients who fail to respond to available vaccines, vaccinated patients with waning efficacy, which can occur between three to six months after immunization, and patients for whom current treatments are contraindicated. Without suitable treatments, high-risk patients remain vulnerable to severe COVID-19 and associated hospitalization and death.
Previous report
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 report
The trial is comprised of two study populations based on the type of SOC received: 1) the “supportive care population,” evaluating bemnifosbuvir as monotherapy (primary analysis), and 2) the “combination antiviral population,” assessing combination therapy if the SOC includes other compatible antiviral drugs against COVID-19 (secondary analysis). In this study, 2,221 patients were enrolled into the supportive care monotherapy cohort and only 74 patients were enrolled into the combination cohort.
Previous report
The primary endpoint of the SUNRISE-3 study is all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort. Secondary endpoints include other measurements of patient outcomes though Day 60 post treatment.
Previous report
Currently, we anticipate to report the results of the SUNRISE-3 study in the second half of 2024.
Previous report
manufacture increasing quantities of bemnifosbuvir drug substance and drug product in anticipation of potential commercialization;
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Reworded paragraphs (35)
Previous wording
We are a clinical-stage biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biology, biochemistry and virology to discover and develop novel orally administered product candidates to treat serious viral diseases. Currently, we are developing our lead product candidate, bemnifosbuvir, in a global Phase 3 clinical trial as a monotherapy for the treatment of COVID-19, and in a global Phase 2 clinical trial as part of a combination therapy with ruzasvir, an NS5A inhibitor, for the treatment of HCV infection.
Current wording
We are a clinical-stage biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biology, biochemistry and virology to discover and develop novel orally administered product candidates to treat serious viral diseases. Currently, we are developing our lead product candidate, the combination of bemnifosbuvir and ruzasvir, an NS5A inhibitor, for the treatment of hepatitis C virus (“HCV”) infection.
Previous wording
Derived from our internal discovery program, bemnifosbuvir (“AT-527”), is an investigational, novel, orally administered guanosine nucleotide analog polymerase inhibitor that combines a unique nucleotide scaffold with novel double prodrugs for the intended purpose of inhibiting the enzymes central to viral replication. We believe that utilizing this double prodrug moiety approach allows us to maximize formation of the active metabolite potentially resulting in an oral antiviral product candidate that is selective for and highly effective at preventing replication and transcription of SARS-CoV-2, the causative agent of COVID-19, HCV and other single ssRNA viruses while avoiding toxicity to host cells.
Current wording
Derived from our internal discovery program, bemnifosbuvir, is an investigational, novel, orally administered guanosine nucleotide analog polymerase inhibitor that combines a unique nucleotide scaffold with novel double prodrugs for the intended purpose of inhibiting the enzymes central to viral replication. We believe that utilizing this double prodrug moiety approach allows us to maximize formation of the active metabolite potentially resulting in an oral antiviral product candidate that is selective for and highly effective at preventing replication and transcription of HCV and other single ssRNA viruses while avoiding toxicity to host cells.
Previous wording
In the US, HCV is recognized as a health crisis with approximately 2.4 million individuals estimated to be infected. Prevalence of HCV in the US is expected to remain constant over the coming years as rising HCV is incidence largely attributable to the opioid crisis, IV drug use, and HCV reinfection, especially among younger adults, offsets the number of new patients treated.
Current wording
In the US, HCV is recognized as a health crisis with approximately 2.4 million individuals estimated to be infected. Prevalence of HCV in the US is expected to remain constant over the coming years as rising HCV incidence largely attributable to the opioid crisis, IV drug use, and HCV reinfection, especially among younger adults, offsets the number of new patients treated.
Previous 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.
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”) in the per-protocol adherent population. Other virologic endpoints include SVR12 in the per-protocol population regardless of treatment adherence, which we refer to as the efficacy evaluable population, virologic failure, SVR at week 24 post-treatment and resistance.
Previous wording
In June 2024, at the European Association for the Study of Liver Disease Congress, we presented data from the 60 patient lead-in cohort. These data showed an SVR12 rate of 97% following the eight weeks of treatment. Two patients in the lead-in cohort (genotype 1b and genotype 2b) experienced a post-treatment relapse. Each of these patients had low plasma drug levels and viral mutations that were similar at baseline and 12-weeks post-treatment time points, which we believe indicates that the relapse was due to treatment non-adherence rather than viral resistance. The data from the lead-in cohort also showed that viral kinetics were similar in genotype 1 and genotype 3 infected patients, including a 100% SVR12 rate in historically difficult-to-treat genotype 3 infected patients. In the lead-in cohort, the combination of bemnifosbuvir and ruzasvir was generally well tolerated. There were no drug-related serious adverse events or treatment discontinuations, and adverse events were mostly mild.
Current wording
In June 2024, at the European Association for the Study of Liver Disease Congress, we presented data from the 60 patient lead-in cohort. These data showed an SVR12 rate of 97% in the efficacy evaluable population following the eight weeks of treatment. Two patients in the lead-in cohort (genotype 1b and genotype 2b) experienced a post-treatment relapse. Each of these patients had low plasma drug levels and viral mutations that were similar at baseline and 12-weeks post-treatment time points, which we believe indicates that the relapse was due to treatment non-adherence rather than viral resistance. The data from the lead-in cohort also showed that viral kinetics were similar in genotype 1 and genotype 3 infected patients, including a 100% SVR12 rate in historically difficult-to-treat genotype 3 infected patients. In the lead-in cohort, the combination of bemnifosbuvir and ruzasvir was generally well tolerated. There were no drug-related serious adverse events or treatment discontinuations, and adverse events were mostly mild.
Previous 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.
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 2025.
Previous 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.
Current wording
We believe we are well capitalized to advance our current programs. We had $482.8 million in cash, cash equivalents and marketable securities at September 30, 2024. Based on our current plans, we anticipate these financial resources will allow us to advance our current and planned clinical programs to and through key inflection points including the completion of clinical development of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV and to fund our activities through 2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect.
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 or debt financings, collaborative or other arrangements with third parties, or through other sources of financing. Our failure to meet the primary endpoints of our COVID-19 SUNRISE-3 Phase 3 clinical trial may make such financing more difficult. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
Previous wording
In addition to a non-refundable upfront payment that we made in February 2022, we will be required to pay Merck milestone payments upon our achievement of certain development, regulatory and sales-based milestones. Additionally, we will pay Merck tiered royalties based on annual net sales of Products ranging from high single digits to mid-teens percentages. Our royalty payment obligations will continue until the later of (i) the expiration of the last to expire valid claim of a licensed Merck patent claiming such Product and (ii) a period of years after the first commercial sale of such Product in such country. We may terminate the Merck License Agreement for convenience upon prior written notice. The first potential milestone, in the amount of $5.0 million, would be payable upon the commencement of a Phase 3 clinical trial.
Current wording
In addition to a non-refundable upfront payment that we made in February 2022, we will be required to pay Merck milestone payments upon our achievement of certain development, regulatory and sales-based milestones. Additionally, we will pay Merck tiered royalties based on annual net sales of Products ranging from high single digits to mid-teens percentages. Our royalty payment obligations will continue until the later of (i) the expiration of the last to expire valid claim of a licensed Merck patent claiming such Product and (ii) a period of years after the first commercial sale of such Product in such country. We may terminate the Merck License Agreement for convenience upon prior written notice. The first potential milestone, in the amount of $5.0 million, would be payable upon the commencement of the HCV Phase 3 clinical trial that we are currently planning to initiate in 2025 subject to discussion and alignment with regulatory authorities.
Previous 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.
Current wording
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $482.8 million. Net cash used in operating activities was $105.1 million for the nine months ended September 30, 2024.
Previous wording
We expect that our net cash used in operating activities will remain significant as we advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, manufacture such products at commercial scale and otherwise pursue commercialization activities; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. In addition, we may incur additional costs as we continue to operate as a public company. We believe that our available cash and cash equivalents will be sufficient to fund our planned operations 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 expect that our net cash used in operating activities will remain significant as we advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, manufacture such products at commercial scale and otherwise pursue commercialization activities; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. In addition, we may incur additional costs as we continue to operate as a public company. We believe that our available cash and cash equivalents will be sufficient to fund our planned operations through 2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect.
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 or debt financings, collaborative or other arrangements with third parties, or through other sources of financing. Our failure to meet the primary endpoint of our COVID-19 SUNRISE-3 Phase 3 clinical trial may make such financing more difficult. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
Previous wording
continue discovery and IND-enabling activities in anticipation of nominating a protease inhibitor product candidate for the treatment of COVID-19;
Current wording
continue discovery and IND-enabling activities in anticipation of nominating a protease inhibitor product candidate for the treatment of respiratory and other diseases resulting from infection with single stranded RNA viruses;
Previous wording
initiate clinical development of a protease inhibitor for the treatment of COVID-19;
Current wording
initiate clinical development of a protease inhibitor for the treatment of respiratory and other diseases resulting from infection with single stranded RNA viruses;
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 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.
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 September 30, 2024 and 2023, we recorded a net reduction to research and development expenses of $0 million and $3.7 million, respectively, related to credits received from Roche. During the nine months ended September 30, 2024 and 2023, we recorded a net reduction to research and development expenses of $1.3 million and $12.6 million, respectively, related to credits received from Roche. These credits were the result, following the termination of the Roche License Agreement, of changes and adjustments by Roche in estimated amounts of expenses reported by Roche during the period in which we and Roche shared costs associated with the development of bemnifosbuvir. We do not anticipate to receive any additional credits from Roche or record any related additional net reductions to research and development expenses.
Previous wording
We are focusing substantially all of our resources on the development of our product candidates, particularly bemnifosbuvir for the treatment of COVID-19 and the combination of bemnifosbuvir and ruzasvir for the treatment of HCV. We expect our research and development expenses to vary quarter over quarter as we complete our SUNRISE-3 Phase 3 clinical trial, advance our HCV clinical program which we expect will include Phase 3 clinical development if our Phase 2 clinical trial is successful, pursue regulatory approval of our product candidates and prepare for the possible commercialization of these product candidates. Predicting the timing or cost to complete our clinical programs, validate our commercial manufacturing and supply processes and manufacture of product at commercial scale is difficult and delays may occur because of many factors, including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate or the time to complete planned clinical trials is extended due to delays in enrollment or otherwise, we could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, we are unable to predict with any certainty when our product candidates, if ever, will receive regulatory approval.
Current wording
We are focusing substantially all of our resources on the development of our product candidates. We expect our research and development expenses to vary quarter over quarter particularly as we advance our HCV clinical program into Phase 3 clinical development if our Phase 2 clinical trial is successful, pursue regulatory approval of our product candidates and prepare for the possible commercialization of these product candidates. Predicting the timing or cost to complete our clinical programs, validate our commercial manufacturing and supply processes and manufacture of product at commercial scale is difficult and delays may occur because of many factors, including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate or the time to complete planned clinical trials is extended due to delays in enrollment or otherwise, we could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, we are unable to predict with any certainty when our product candidates, if ever, will receive regulatory approval.
Previous 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.
Current wording
Research and development expenses decreased by $2.0 million from $28.2 million for the three months ended September 30, 2023 to $26.2 million for the three months ended September 30, 2024. The net decrease was primarily driven by lower external spend related to our COVID-19 Phase 3 SUNRISE-3 clinical trial offset by higher spend related to our HCV Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir.
Previous 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.
Current wording
General and administrative expenses decreased by $1.6 million from $12.6 million for the three months ended September 30, 2023 to $11.0 million for the three months ended September 30, 2024. The net decrease was primarily related to lower professional fees.
Previous 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.
Current wording
Interest income and other, net, decreased by $1.6 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023, primarily due to lower investment balances.
Previous wording
Research and development expenses increased by $41.3 million from $51.0 million for the six months ended June 30, 2023 to $92.3 million for the six 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.
Current wording
Research and development expenses increased by $39.2 million from $79.2 million for the nine months ended September 30, 2023 to $118.4 million for the nine months ended September 30, 2024. The net increase was primarily driven by higher external spend related to our COVID-19 Phase 3 SUNRISE-3 clinical trial and our HCV Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir.
Previous wording
General and administrative expenses decreased by $1.3 million from $25.8 million for the six months ended June 30, 2023 to $24.5 million for the six months ended June 30, 2024. The net decrease was primarily related to lower professional fees.
Current wording
General and administrative expenses decreased by $2.9 million from $38.4 million for the nine months ended September 30, 2023 to $35.5 million for the nine months ended September 30, 2024. The net decrease was primarily related to lower professional fees.
Previous wording
Interest income and other, net, decreased by $0.1 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023, primarily due to lower investment balances.
Current wording
Interest income and other, net, decreased by $1.7 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023, primarily due to lower investment balances.
Previous wording
We recorded an income tax expense of $0.5 million and $0.4 million for the six months ended June 30, 2024 and June 30, 2023, respectively.
Current wording
We recorded an income tax expense of $0.7 million for each of the nine months ended September 30, 2024 and 2023.
Previous 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.
Current wording
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $482.8 million. Based upon our current operating plan, we believe that our available cash, cash equivalents and marketable securities will be sufficient to fund our planned operations through 2027.
Previous wording
We entered into an open market sales agreement (“Sales Agreement”) with Jefferies LLC (“Jefferies”), in 2021 pursuant to which we may from time to time offer and sell shares of our common stock for an aggregate offering price of up to $200.0 million, through or to Jefferies, acting as sales agent or principal. We have agreed to pay Jefferies a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Jefferies with customary indemnification and contribution rights. As of June 30, 2024, no shares have been issued under the Sales Agreement. The shares will be offered and sold under the Company’s shelf registration statement on Form S-3 and related prospectus filed with the SEC on November 24, 2021, as amended.
Current wording
We entered into an open market sales agreement (“Sales Agreement”) with Jefferies LLC (“Jefferies”), in 2021 pursuant to which we may from time to time offer and sell shares of our common stock for an aggregate offering price of up to $200.0 million, through or to Jefferies, acting as sales agent or principal. We have agreed to pay Jefferies a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Jefferies with customary indemnification and contribution rights. As of September 30, 2024, no shares have been issued under the Sales Agreement. The shares may be offered and sold under the Company’s shelf registration statement on Form S-3 and related prospectus filed with the SEC on November 24, 2021, as amended.
Previous wording
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. 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 require additional capital to develop our product candidates and fund operations for the foreseeable future. The failure of our COVID-19 Phase 3 SUNRISE-3 clinical trial to meet its primary endpoint may make this capital raising effort more difficult. We may seek to raise capital through public or private equity or debt financings, collaborative arrangements with third parties, or through other sources of financing. The additional capital that we will require will depend upon many factors, including:
Previous wording
The following table sets forth the primary sources and uses of cash, cash equivalents, and restricted cash for each of the periods presented below:
Current wording
The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented below:
Previous 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.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $105.1 million. Cash used in operating activities was primarily due to a net loss of $134.8 million, a decrease in accrued expenses and other current liabilities of $8.4 million and an accretion of premium and discounts on marketable securities of $9.1 million, partially offset by a stock-based compensation expense of $37.5 million, a decrease in prepaid expenses and other current assets of $8.3 million and an increase in accounts payable of $1.5 million.
Previous 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.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2023 was $63.6 million. Net cash used in operating activities was primarily due to net loss of $96.8 million, accretion of premium and discounts on marketable securities of $11.1 million and a net decrease in accounts payable of $2.1 million, partially offset by stock-based compensation expense of $37.3 million, a decrease in prepaid expenses of $6.0 million and an increase in accrued expenses of $2.9 million.
Previous 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.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2024 was $59.5 million and consisted of sales and maturities of marketable securities of $462.1 million offset by purchases of marketable securities of $402.7 million.
Previous 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.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2023 was $12.5 million and consisted of sales and maturities of marketable securities of $527.7 million partially offset by purchases of marketable securities of $515.1 million.
Previous 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”).
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $0.3 million and consisted of proceeds from the issuance of our common stock under our Employee Stock Purchase Plan (“ESPP”).
Previous 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.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2023 was $0.3 million and consisted of proceeds from the issuance of our common stock under the ESPP.
Previous 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.
Current wording
There have been no material changes to our contractual obligations during the three and nine months ended September 30, 2024 from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.
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 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.
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 nine months ended September 30, 2024, there were no material changes to our critical accounting policies and estimates from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2023.