Atea Pharmaceuticals, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
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, 2026 · Filed Nov 9, 2026
AVIR$4.41+2.3%Stored close · as of Nov 9, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001193125-26-347021
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsOther InformationCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001193125-26-453807
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsOther InformationThe 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 534 previous paragraphs and 542 current paragraphs.
475 unchanged; 56 reworded; 8 added; 0 removed; 3 previous and 3 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 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 (8)
Current report
Our loan and security agreement with Hercules Capital, Inc. (“Hercules”) contains operating and financial covenants that may restrict our business and financing activities, is secured by substantially all of our assets, including our intellectual property, and we may be required to repay our outstanding indebtedness earlier than we expect, any of which could have a material adverse effect on our business.
Current report
In November 2026, we entered into a loan and security agreement (the "Loan and Security Agreement") with Hercules, as agent and the lenders party thereto, which provides for term loans in an aggregate principal amount of up to $200.0 million, of which $65.0 million was funded at closing. The term loans bear interest at floating rates based on the prime rate, subject to specified floors, payable monthly in arrears, and mature on November 5, 2031. Increases in the prime rate would increase our debt service obligations, and servicing our indebtedness will require a substantial amount of cash and will reduce the funds available for our operations. In addition, of the amounts not funded at closing, $105.0 million is available only upon the achievement of specified milestones and $30.0 million is available only in lenders’ sole discretion. Accordingly, we may never have access to the full amount of the facility, and we cannot be certain that the milestones will be achieved or that lenders will elect to make discretionary amounts available to us.
Current report
The Loan and Security Agreement contains customary affirmative and restrictive covenants that, among other things, limit our ability to transfer or dispose of assets, merge with other companies or consummate certain changes of control, make investments, incur additional indebtedness and liens and enter into new businesses. We therefore may not be able to engage in any of the foregoing transactions unless we obtain the consent of Hercules or terminate the Loan and Security Agreement, which may limit our operating flexibility. The Loan and Security Agreement also contains a minimum cash covenant that will require us to maintain cash equal to a specified percentage of our outstanding obligations under the Loan and Security Agreement unless we meet a specified market capitalization. Additionally, the Loan and Security Agreement also contains a performance covenant that will require us, if BEM/RZR is approved for marketing in the US, to satisfy at least one of (1) a combination of a market capitalization test and a minimum cash test, (2) a minimum cash test, or (3) a net product revenue test. Because the applicability of the minimum cash covenant, and our ability to satisfy the market capitalization prong of the performance covenant, depend in part on our market capitalization, a decline in the trading price of our common stock, which may occur for reasons unrelated to our business or results of operations, could cause the minimum cash covenant to apply, or make the performance covenant more difficult to satisfy, at times when they otherwise would not. These covenants could restrict our ability to operate our business and pursue our business strategies, and we may not be able to comply with these covenants in the future. If the minimum cash covenant becomes applicable, a portion of our cash will effectively be unavailable to fund our operations, and any failure to comply with the covenants in the Loan and Security Agreement could result in an event of default.
Current report
Our obligations under the Loan and Security Agreement are secured by a security interest in substantially all of our assets, including our intellectual property, and certain of our future subsidiaries, if any, may be required to join as co-borrowers or guarantors and guarantee our obligations and pledge substantially all of their assets, including intellectual property, to secure such guarantees. Upon the occurrence of an event of default, Hercules may accelerate all of our outstanding obligations, including principal, interest and any applicable prepayment charges and end of term charges, and our obligations will be automatically accelerated upon certain insolvency, liquidation, bankruptcy or similar events. If our obligations are accelerated, we may not have sufficient cash to repay them, and Hercules could foreclose on the collateral, including intellectual property that is critical to our business. Any voluntary prepayment of the term loans is also subject to prepayment and end of term fees, which could make it more costly for us to refinance the facility. In addition, because our assets, including our intellectual property, are pledged to Hercules, our ability to obtain additional debt or other secured financing may be limited, and any future financing may be more difficult or costly to obtain.
Current report
If we raise additional funds by issuing equity securities, our stockholders will suffer dilution, and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. Debt financing, such as our Loan and Security Agreement, or other financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets. For additional information regarding restrictive covenants in our Loan and Security Agreement, see Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources”.
Current report
the scope, costs and timing of establishing commercialization capabilities related to the potential US commercialization, if approved, of BEM/RZR or any other product candidate;
Current report
(a) On November 9, 2026, Wayne Foster, the Company’s Executive Vice President, Chief Accounting Officer, informed the Company of his resignation, effective November 13, 2026. Mr. Foster intends to provide consulting services to the Company initially through February 2027 to facilitate the transition of his role.
Reworded paragraphs (56)
Previous wording
You should carefully consider the risks and uncertainties described below, as well as the other information in this Quarterly Report on Form 10-Q, including our unaudited condensed consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Results of Operations and Financial Condition.” Our business, financial condition, results of operations or prospects could be materially and adversely affected if any of these risks occurs, and as a result, the market price of our common stock could decline and you could lose all or part of your investment. Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below.
Current wording
You should carefully consider the risks and uncertainties described below, as well as the other information in this Quarterly Report on Form 10-Q, including our unaudited condensed consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Our business, financial condition, results of operations or prospects could be materially and adversely affected if any of these risks occurs, and as a result, the market price of our common stock could decline and you could lose all or part of your investment. Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below.
Previous wording
We are a late-stage clinical biopharmaceutical company. Our operations to date have been limited to financing and staffing our company, developing our technology, and identifying and developing our product candidates. Our prospects must be considered in light of the uncertainties, risks, expenses and difficulties frequently encountered by biopharmaceutical companies in their early stages of operations. We have not yet demonstrated an ability to successfully develop, obtain marketing approval, manufacture a product on a commercial-scale, or conduct sales and marketing activities necessary for successful product commercialization, or have third parties to do these activities on our behalf. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing, obtaining marketing approval for and commercializing antiviral therapies.
Current wording
We are a clinical biopharmaceutical company in the late stages of development of our lead product candidate, the fixed-dose combination of bemnifosbuvir and ruzasvir (“BEM/RZR”) for the treatment of hepatitis C virus (“HCV”). In addition to our HCV program, we have a clinical stage program evaluating AT-587 for the treatment of hepatitis E virus (“HEV”). Our operations to date have been limited to financing and staffing our company, developing our technology, and identifying and developing our product candidates. Our prospects must be considered in light of the uncertainties, risks, expenses and difficulties frequently encountered by biopharmaceutical companies in their early stages of operations. We have not yet demonstrated an ability to successfully develop, obtain marketing approval, manufacture a product on a commercial-scale, or conduct sales and marketing activities necessary for successful product commercialization, or have third parties to do these activities on our behalf. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing, obtaining marketing approval for and commercializing antiviral therapies.
Previous wording
As we continue to build our business, including completing Phase 3 clinical trials and preparing and potentially submitting applications seeking marketing approval for our hepatitis C virus (“HCV”) product candidate, we expect our financial condition and operating results may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results included in this report or reports for any other particular prior quarterly or annual period as indications of future operating performance.
Current wording
As we continue to build our business, including completing Phase 3 clinical trials and preparing and potentially submitting applications seeking marketing approval for our HCV product candidate, we expect our financial condition and operating results may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results included in this report or reports for any other particular prior quarterly or annual period as indications of future operating performance.
Previous wording
We have incurred significant operating expenses since our inception. For the six months ended June 30, 2026 and the year ended December 31, 2025, our operating expenses were $83.1 million and $180.9 million, respectively. As of June 30, 2026, we had an accumulated deficit of $600.9 million.
Current wording
We have incurred significant operating expenses since our inception. For the nine months ended September 30, 2026 and the year ended December 31, 2025, our operating expenses were $117.1 million and $180.9 million, respectively. As of September 30, 2026, we had an accumulated deficit of $633.1 million.
Previous wording
successfully complete clinical trials and seek regulatory approval for the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, AT-587 for the treatment of hepatitis E virus (“HEV”) or other product candidates, if any;
Current wording
successfully complete clinical trials and seek regulatory approval for BEM/RZR for the treatment of HCV, AT-587 for the treatment of HEV or other product candidates, if any;
Previous wording
Since inception, we have incurred substantial operating expenses. We expect to incur substantial expenses in connection with our current and planned business activities, particularly completing the late stage development of the regimen of bemnifosbuvir and ruzasvir, the manufacture of drug supply, the preparation and submission of an NDA and other similar applications seeking marketing approval for our HCV product candidate. Also, we anticipate that we may incur substantial expenses in connection with the development of AT-587 for the treatment of HEV, and in connection with the discovery, license or other acquisition and potential development of other product candidates, if any. If we successfully develop and receive regulatory approval to market the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV or any other product candidates, we expect we will also incur substantial expenses in connection with the establishment of sales, marketing, internal systems and distribution infrastructure to commercialize such products. Additionally, in 2025, our Board authorized and we completed a share repurchase program expending the total authorized amount of $25.0 million, net of transaction costs and excise taxes, in connection with the repurchase of 7,673,792 shares of our common stock.
Current wording
Since inception, we have incurred substantial operating expenses. We expect to incur substantial expenses in connection with our current and planned business activities, particularly completing the late stage development of BEM/RZR, the manufacture of drug supply, the preparation and submission of an NDA and other similar applications seeking marketing approval and engaging in pre-launch activities, including establishing directly or with third parties, sales, marketing, internal systems and distribution infrastructure to commercialize our HCV product candidate, if approved. Additionally, we anticipate to incur substantial expenses in connection with the development of AT-587 for the treatment of HEV, and in connection with the discovery, license or other acquisition and potential development of other product candidates, if any. Further, if we successfully develop and receive regulatory approval to market BEM/RZR for the treatment of HCV or any other product candidates, we expect we will incur substantial expenses in connection with the commercialization of such product candidates.
Previous wording
If our cash, cash equivalents and marketable securities are not sufficient to fund our future operations, we will need additional capital to fund these activities, which we may raise through equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources. Additional sources of financing might not be available on favorable terms, if at all. If we do not succeed in raising additional funds on acceptable terms, we might be unable to initiate or complete planned clinical trials or seek regulatory approvals for our product candidates from the FDA, or any foreign regulatory authorities, and could be forced to discontinue product development. In addition, attempting to secure additional financing could divert the time and attention of our management from day-to-day activities and may harm our product candidate development efforts.
Current wording
If we do not succeed in raising additional funds on acceptable terms, we might be delayed or unable to initiate or complete planned clinical trials or seek regulatory approvals for our product candidates from the FDA, or any foreign regulatory authorities, be delayed or unable to initiate and complete activities, including pre-launch activities and other activities related to commercialization of product candidates, if any, for which we receive marketing approval or forced to discontinue product development or commercialization efforts. In addition, attempting to secure additional financing could divert the time and attention of our management from day-to-day activities and may harm our product candidate development and commercialization efforts.
Previous wording
the scope, progress, results and costs of our preclinical studies and clinical trials, in particular the completion of our Phase 3 development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV;
Current wording
the scope, progress, results and costs of our preclinical studies and clinical trials, in particular the completion of our Phase 3 development of BEM/RZR for the treatment of HCV;
Previous wording
the timing of, and the costs involved in, obtaining marketing approvals for our current and future product candidates in regions where we choose to commercialize any products including for example, our anticipated submission to the FDA of an NDA for marketing approval of our HCV product candidate the regimen of bemnifosbuvir and ruzasvir;
Current wording
the timing of, and the costs involved in, obtaining marketing approvals for our current and future product candidates in regions where we choose to commercialize any products including for example, our anticipated submission to the FDA of an NDA for marketing approval of our HCV product candidate BEM/RZR;
Previous wording
the costs of manufacturing and commercialization activities for any approved product candidate to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of manufacturing commercial supply at a scale to meet demand and the costs and timing of establishing commercialization capabilities for and conducting product sales, marketing, distribution activities;
Current wording
the costs of manufacturing and commercialization activities for any approved product candidate to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of manufacturing commercial supply at a scale to meet demand and the costs of conducting product sales, marketing and distribution activities in connection with the commercialization of any such product candidates;
Previous wording
Currently, we do not have any committed external source of funds or other support and we cannot be certain that additional funding will be available on acceptable terms, if needed. Our ability to access potential sources of future liquidity and raise funds will depend upon financial, economic and geopolitical conditions and other factors, many of which are beyond our control. These external factors, including rates of interest and inflation, will also impact and may increase substantially costs we incur in connection with any potential fundraising. If we are unable to raise additional capital in sufficient amounts, on terms acceptable to us, or on a timely basis, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.
Current wording
Our ability to access potential sources of future liquidity and raise funds will depend upon financial, economic and geopolitical conditions and other factors, many of which are beyond our control. These external factors, including rates of interest and inflation, will also impact and may increase substantially costs we incur in connection with any potential fundraising. If we are unable to raise additional capital in sufficient amounts, on terms acceptable to us, or on a timely basis, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.
Previous wording
In the future, we may enter into strategic collaborations or other transactions. While we remain open to consideration of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions, we believe that it is most likely that actionable alternatives may be available after we receive the results from our currently ongoing HCV Phase 3 development program. In July 2026, we announced positive topline results from C-BEYOND, our Phase 3 clinical trial conducted in the US and Canada. In June 2026, we announced that we had completed enrollment of patients in C-FORWARD, our Phase 3 clinical trial being conducted outside the US and Canada. Currently, we anticipate to report topline results from C-FORWARD early in the first quarter of 2027.
Current wording
In the future, we may enter into strategic collaborations or other transactions. While we remain open to consideration of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions, we believe that it is most likely that actionable alternatives may be available after we receive the results from our currently ongoing HCV Phase 3 development program. In July 2026, we announced positive topline results from C-BEYOND, our Phase 3 clinical trial conducted in the US and Canada. In June 2026, we announced that we had completed enrollment of patients in C-FORWARD, our Phase 3 clinical trial being conducted outside the US and Canada. Currently, we anticipate to report topline results from C-FORWARD in the first quarter of 2027.
Previous wording
We incurred a net loss of $78.4 million for the six months ended June 30, 2026. Our ability to achieve and sustain future profitability depends upon our ability to generate revenue from product sales. We have not generated product revenue and we do not expect to generate product revenue unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, at least one of our product candidates. Our HCV and HEV product candidates and future product candidates, if any, require additional preclinical and clinical development, regulatory review and approval, substantial investment in and access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. Currently, we do not anticipate generating revenue from product sales for at least the next few years. Our ability to generate revenue depends on a number of factors, including, but not limited to:
Current wording
We incurred a net loss of $110.5 million for the nine months ended September 30, 2026. Our ability to achieve and sustain future profitability depends upon our ability to generate revenue from product sales. We have not generated product revenue and we do not expect to generate product revenue unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, at least one of our product candidates. Our HCV and HEV product candidates and future product candidates, if any, require additional preclinical and clinical development, regulatory review and approval, substantial investment in and access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. Currently, we do not anticipate generating revenue from product sales in the near term. Our ability to generate revenue depends on a number of factors, including, but not limited to:
Previous wording
timely completion of our clinical trials, including C-FORWARD, our HCV Phase 3 clinical trial evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, and the clinical trials of AT-587 for the treatment of HEV, as well as our preclinical studies and other clinical trials, each of which may be significantly slower or more costly than we currently anticipate and will depend substantially upon the performance of third-party contractors;
Current wording
timely completion of our clinical trials, including C-FORWARD, our HCV Phase 3 clinical trial evaluating BEM/RZR for the treatment of HCV, and the clinical trials of AT-587 for the treatment of HEV, as well as our preclinical studies and other clinical trials, each of which may be significantly slower or more costly than we currently anticipate and will depend substantially upon the performance of third-party contractors;
Previous wording
our ability to successfully establish a commercial strategy and thereafter commercialize our HCV and HEV product candidates or any future product candidates, in the US and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; and
Current wording
our ability to establish a commercial infrastructure and commercialization strategy and thereafter to successfully commercialize our HCV and HEV product candidates or any future product candidates, in the US and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; and
Previous wording
Many of the factors listed above are beyond our control, and could cause us to experience significant delays, incur substantially greater expenses than anticipated or prevent us from obtaining regulatory approvals or commercializing our product candidates. Even if we are able to commercialize our product candidates, we may not be able to achieve and maintain profitability after generating product sales or meet outside expectations for our profitability. If we are unable to achieve or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially adversely affected. In addition, if we are unable to generate sufficient revenue through the sale of any products, we may be unable to continue operations.
Current wording
Many of the factors listed above are beyond our control, and could cause us to experience significant delays, incur substantially greater expenses than anticipated or prevent us from obtaining regulatory approvals or commercializing our product candidates. Even if we are able to commercialize our product candidates, we may not be able to achieve and maintain profitability after generating product sales or meet outside expectations for our profitability. If we are unable to achieve or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially adversely affected. In addition, if we are unable to generate sufficient revenue through the sale of any products, we may be unable to meet our interest and debt payment obligations under the terms of the Loan and Security and Agreement, which would result in an event of default which could jeopardize our ability to continue operations.
Previous wording
Our business is highly dependent on the success of our lead product candidate, the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, which requires significant additional clinical testing, principally including successful completion of the C-FORWARD Phase 3 clinical trial, before we can seek regulatory approval and potentially launch commercial sales. If this product candidate fails in clinical development, does not receive regulatory approval or is not successfully commercialized, or is significantly delayed in doing so, our business will be harmed.
Current wording
Our business is highly dependent on the success of our lead product candidate, BEM/RZR for the treatment of HCV, which requires significant additional clinical testing, principally including successful completion of the C-FORWARD Phase 3 clinical trial, before we can seek regulatory approval and potentially launch commercial sales. If this product candidate fails in clinical development, does not receive regulatory approval or is not successfully commercialized, or is significantly delayed in doing so, our business will be harmed.
Previous wording
A substantial portion of our business and future success depends on our ability to develop, obtain regulatory approval for and successfully commercialize the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV. We currently have no products that are approved for commercial sale and have not successfully completed the development of any of our product candidates, and we may never be able to develop marketable products.
Current wording
A substantial portion of our business and future success depends on our ability to develop, obtain regulatory approval for and successfully commercialize BEM/RZR for the treatment of HCV. We currently have no products that are approved for commercial sale and have not successfully completed the development of any of our product candidates, and we may never be able to develop marketable products.
Previous wording
During the near term, we expect to devote substantial efforts and financial resources to complete the Phase 3 clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, manage clinical, medical affairs and manufacturing activities, seek and obtain regulatory approvals in multiple jurisdictions, secure additional sources of manufacturing supply and capacity, build or otherwise access a commercial organization, and engage in significant pre-launch efforts.
Current wording
During the near term, we expect to devote substantial efforts and financial resources to complete the Phase 3 clinical development of BEM/RZR for the treatment of HCV, manage clinical, medical affairs and manufacturing activities, seek and obtain regulatory approvals in multiple jurisdictions, secure additional sources of manufacturing supply and capacity, build or otherwise access a commercial organization, and engage in significant pre-launch efforts.
Previous wording
We cannot be certain that C-FORWARD, our Phase 3 clinical trial evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, or any clinical trial evaluating AT-587 for the treatment of HEV will be successful. Additionally, we cannot be certain that the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, AT-587 for the treatment of HEV or future product candidates, if any, we may subsequently develop will receive regulatory approval or be successfully commercialized even if we receive regulatory approval. Further, our development of any product candidate may be delayed or suspended, which may affect our ability to successfully commercialize such product candidate. Additionally, our ability to successfully commercialize a product will also be dependent upon our ability to timely manufacture at commercial scale the quantities of product that will satisfy market demand.
Current wording
We cannot be certain that C-FORWARD, our Phase 3 clinical trial evaluating BEM/RZR for the treatment of HCV, or any clinical trial evaluating AT-587 for the treatment of HEV will be successful. Additionally, we cannot be certain that BEM/RZR for the treatment of HCV, AT-587 for the treatment of HEV or future product candidates, if any, we may subsequently develop will receive regulatory approval or be successfully commercialized even if we receive regulatory approval. Further, our development of any product candidate may be delayed or suspended, which may affect our ability to successfully commercialize such product candidate. Additionally, our ability to successfully commercialize a product will also be dependent upon our ability to timely manufacture at commercial scale the quantities of product that will satisfy market demand.
Previous wording
Even if we receive approval to market our HCV product candidate, our HEV product candidate or any other product candidate, we cannot be certain that such product candidate will be as or more effective than commercially available alternatives, successfully commercialized or widely accepted in the marketplace. There are currently approved and well established oral antiviral HCV products against which we would be required to compete if the regimen of bemnifosbuvir and ruzasvir is approved for the treatment of HCV.
Current wording
Even if we receive approval to market our HCV product candidate, our HEV product candidate or any other product candidate, we cannot be certain that such product candidate will be as or more effective than commercially available alternatives, successfully commercialized or widely accepted in the marketplace. There are currently approved and well established oral antiviral HCV products against which we would be required to compete if BEM/RZR is approved for the treatment of HCV.
Previous wording
We cannot be certain that, if approved, the safety and efficacy profile of the regimen of bemnifosbuvir and ruzasvir will be consistent with the results observed in clinical trials. If we are not able to successfully complete the clinical development of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, if the required regulatory approvals for this product candidate are not obtained, if there are significant delays in completing the development or obtaining approval of this product candidate or in supplying commercial quantities of the regimen of bemnifosbuvir and ruzasvir or any other product, if approved, on an uninterrupted basis, or if we are otherwise not commercially successful, our business, financial condition and results of operations may be materially harmed.
Current wording
We cannot be certain that, if approved, the safety and efficacy profile of BEM/RZR will be consistent with the results observed in clinical trials. If we are not able to successfully complete the clinical development of the BEM/RZR for the treatment of HCV, if the required regulatory approvals for this product candidate are not obtained, if there are significant delays in completing the development or obtaining approval of this product candidate or in supplying commercial quantities of BEM/RZR or any other product, if approved, on an uninterrupted basis, or if we are otherwise not commercially successful, our business, financial condition and results of operations may be materially harmed.
Previous wording
To date, we have not successfully concluded any late-stage or pivotal clinical trials for any of our product candidates. We cannot guarantee that any of our planned or ongoing clinical trials will be initiated or conducted as planned or completed on schedule, if at all. We also cannot be sure that submission of any future IND or similar application for any future product candidate will result in the FDA or other regulatory authority, as applicable, allowing future clinical trials to begin in a timely manner, if at all. Moreover, even for trials that begin or have begun, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials.
Current wording
We cannot guarantee that any of our planned or ongoing clinical trials will be initiated or conducted as planned or completed on schedule, if at all. We also cannot be sure that submission of any future IND or similar application for any future product candidate will result in the FDA or other regulatory authority, as applicable, allowing future clinical trials to begin in a timely manner, if at all. Moreover, even for trials that begin or have begun, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials.
Previous wording
Any inability to successfully complete C-FORWARD, our Phase 3 clinical trial evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV or the completion of our first-in-human Phase 1 and additional planned clinical trials we may initiate for AT-587, our HEV product candidate, could result in additional costs to us or impair our ability to seek approval for our HCV and HEV product candidate and ultimately generate revenue from product sales.
Current wording
Any inability to successfully complete C-FORWARD, our Phase 3 clinical trial evaluating BEM/RZR for the treatment of HCV or the completion of our first-in-human Phase 1 and additional planned clinical trials we may initiate for AT-587, our HEV product candidate, could result in additional costs to us or impair our ability to seek approval for our HCV and HEV product candidate and ultimately generate revenue from product sales.
Previous wording
Further, conducting clinical trials in foreign countries for our HCV and HEV product candidates or other product candidates, if any, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries. For example, clinical trial sites in Ukraine are participating in and have enrolled patients in C-FORWARD, our HCV Phase 3 clinical trial. To the extent that these patients are not able to complete the study or there is a loss of data related to those patients as a result of the ongoing conflict in that area or otherwise, there may be a delay in completing the study or an adverse impact on the results from the study.
Current wording
Further, conducting clinical trials in foreign countries for our HCV and HEV product candidates or other product candidates, if any, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries. For example, clinical trial sites in Ukraine are expected to participate in our HCV pediatric study and are participating in and have enrolled patients in C-FORWARD, our HCV Phase 3 clinical trial. To the extent that these patients in Ukraine are not able to complete the study or there is a loss of data related to those patients as a result of the ongoing conflict in that area or otherwise, there may be a delay in completing the studies or an adverse impact on the results from the studies.
Previous wording
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials being conducted outside North America may change and additional government regulations may be enacted. For instance, with very limited exception for certain EU countries and certain clinical trials, the regulatory landscape related to clinical trials in the EU recently evolved. The EU CTR which was adopted in April 2014 and repeals the EU Clinical Trials Directive (“EU Clinical Trials Directive”), became applicable on January 31, 2022. While the EU Clinical Trials Directive required a separate CTA to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduced a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. With very limited exception for certain EU countries and certain clinical trials including our first-in-human clinical trial of AT-587, all CTAs and clinical trials conducted in the EU (including those which are ongoing) are subject to the provisions of the CTR. As a result, the CTAs we have submitted in connection with the conduct of our HCV Phase 3 clinical trial in the EU were prepared in compliance with the CTR requirements. We have limited experience submitting applications under the CTR. If we or our third-party service providers, such as CROs, encounter difficulties or are unable to comply with the CTR requirements our developments plans would be adversely impacted.
Current wording
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials being conducted outside North America may change and additional government regulations may be enacted. For instance, with very limited exception for certain EU countries and certain clinical trials, the regulatory landscape related to clinical trials in the EU recently evolved. The EU CTR which was adopted in April 2014 and repealed the EU Clinical Trials Directive, became applicable on January 31, 2022. While the EU Clinical Trials Directive required a separate CTA to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduced a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. With very limited exception for certain EU countries and certain clinical trials including our first-in-human clinical trial of AT-587, all CTAs and clinical trials conducted in the EU (including those which are ongoing) are subject to the provisions of the CTR. Even though the CTAs we submitted in connection with the conduct of our HCV Phase 3 clinical trial in the EU were prepared in compliance with the CTR requirements, we have limited experience submitting applications under the CTR. If we or our third-party service providers, such as CROs, encounter difficulties or are unable to comply with the CTR requirements our developments plans would be adversely impacted.
Previous wording
In April 2025, the UK government adopted the Medicines for Human Use (Clinical Trials) Amendment Regulations. The amendment, which will take full effect from April 2026, aims to provide a more flexible regime to make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK and make clinical trials more patient centered.
Current wording
In April 2025, the UK government adopted the Medicines for Human Use (Clinical Trials) Amendment Regulations. The amendment, which took effect from April 2026, aims to provide a more flexible regime to make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK and make clinical trials more patient centered.
Previous wording
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, top-line, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.
Current wording
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or
Previous wording
Furthermore, we have limited financial and personnel resources and are placing significant focus on the development of our lead product candidate, the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, and the development of AT-587 for the treatment of HEV and as such, we may forgo or delay pursuit of opportunities with other future product candidates that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and other future product candidates for specific indications may not yield any commercially viable future product candidates. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to such product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future product candidates.
Current wording
Furthermore, we have limited financial and personnel resources and are placing significant focus on the development of our lead product candidate, BEM/RZR for the treatment of HCV, and the development of AT-587 for the treatment of HEV and as such, we may forgo or delay pursuit of opportunities with other future product candidates that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and other future product candidates for specific indications may not yield any commercially viable future product candidates. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to such product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future product candidates.
Previous wording
Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
Current wording
Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or policy changes could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
Previous wording
The ability of the FDA and foreign regulatory authorities to review or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions including a rapid substantial influx of applications from numerous sponsors as occurred with COVID-19. Average review times at the FDA and foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, the US government has shut down and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. Additionally, government efficiency initiatives, including initiatives and programs recently undertaken in the US, have resulted in a number of employees leaving the FDA which may affect the ability of the agency to process our regulatory submissions which may adversely impact our ability to timely complete critical activities associated with the development of our HCV product candidate.
Current wording
The ability of the FDA and foreign regulatory authorities to review or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions. Average review times at the FDA and foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, the US government has shut down and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. Additionally, government efficiency initiatives, including initiatives and programs recently undertaken in the US, have resulted in significant changes to senior FDA personnel which may affect the ability of the agency to process our regulatory submissions which may adversely impact our ability to timely complete critical activities associated with the development of our HCV product candidate or the FDA’s review of any NDA we may submit.
Previous wording
If a prolonged government shutdown occurs, or funding shortages, staffing limitations, or global health concerns similar to the COVID-19 pandemic prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities on a timely basis, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Current wording
If a prolonged government shutdown occurs, or funding shortages, staffing limitations prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities on a timely basis, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Previous wording
Operating as a public company has in the past and may in the future make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, our board committees or as executive officers. We do not know if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash and cash equivalents position and results of operations.
Current wording
Operating as a public company has in the past and may in the future make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits or coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, our board committees or as executive officers. We do not know if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash and cash equivalents position and results of operations.
Previous wording
The Trump administration is pursuing a two-fold strategy to reduce drug costs in the US. While it is unclear whether and how the Trump administration proposals will be implemented, the Trump administration policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for our product candidates, if approved. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the US to the lowest price in a group of other countries. In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government. On the other hand, the Trump administration is pursuing traditional regulatory pathways to impose drug pricing policies, although final regulations have not yet been published. Pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry.
Current wording
The Trump administration is pursuing a two-fold strategy to reduce drug costs in the US. While it is unclear whether and how the Trump administration proposals will be implemented, the Trump administration policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for our product candidates, if approved. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the US to the lowest price in a group of other countries. In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government. On the other hand, the Trump administration is pursuing traditional regulatory pathways to impose drug pricing policies and published two proposed regulations in December 2025, referred to as Globe and Guard. The final Globe regulation was published in September 2026 and implements a mandatory payment model under which manufacturers of eligible Medicare Part B drugs will be required to pay rebates to the US federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing, although the program is currently subject to legal challenges. The proposed Guard regulations would impose a similar mandatory payment model covering Medicare Part D drugs. We anticipate that each of BEM/RZR for the treatment of HCV and AT-587 for the treatment of HEV, if approved and covered by Medicare, would be classified as Medicare Part D drugs. While the impact of the final Globe and proposed Guard regulations, if finalized, cannot yet be determined, it is likely to be significant. Pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry.
Previous wording
Our HCV product candidate, if approved, is expected to compete directly or indirectly with existing, currently commercialized products. For example, if we successfully develop and receive marketing approval for our HCV product candidate, we anticipate that we will face competition from currently approved oral antiviral HCV products that are well established and widely accepted by physicians, patients and third-party payors, including products marketed and sold by Gilead Sciences, Inc., Asegua Therapeutics LLC, a wholly owned subsidiary of Gilead Sciences, Inc. and AbbVie Inc. Even if approved and commercialized, our HCV product candidate may fail to achieve market acceptance with hospitals, physicians, patients or third-party payors. Hospitals, physicians, patients or third-party payors may conclude that our product is less safe or effective or otherwise less attractive than existing drugs. If our HCV product candidate or other future product candidates, if any, do not receive market acceptance for any reason, our revenue potential would be diminished, which would materially adversely affect our ability to become profitable. Other product candidates, if any, may also compete with existing products in a similar manner.
Current wording
Our HCV product candidate, if approved, is expected to compete directly or indirectly with existing, currently commercialized products. For example, if we successfully develop and receive marketing approval for our HCV product candidate, we anticipate that we will face competition from currently approved oral antiviral HCV products that are well established and widely accepted by physicians, patients and third-party payors, including products marketed and sold by Gilead Sciences, Inc. (“Gilead Sciences”), Asegua Therapeutics LLC, a wholly owned subsidiary of Gilead Sciences, Inc. and AbbVie Inc. (“AbbVie”). Even if approved and commercialized, our HCV product candidate may fail to achieve market acceptance with hospitals, physicians, patients or third-party payors. Hospitals, physicians, patients or third-party payors may conclude that our product is less safe or effective or otherwise less attractive than existing drugs. If our HCV product candidate or other future product candidates, if any, do not receive market acceptance for any reason, our revenue potential would be diminished, which would materially adversely affect our ability to become profitable. Other product candidates, if any, may also compete with existing products in a similar manner.
Previous wording
Many of our competitors have substantially greater capital resources, access to larger pools of capital, robust product candidate pipelines, established presence in the market, deep and broad commercial infrastructures and greater expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than we do. As a result, our competitors may be able to maintain market share or achieve product commercialization or patent or other intellectual property protection earlier than we can. For example, in each of May 2023 and October 2024, the US Patent and Trademark Office (“USPTO”) granted Gilead Sciences patents in the US that include claims which purportedly covers our compound bemnifosbuvir. While we believe the claims in these patents are invalid and unenforceable and will expire not later than June 15, 2028, if Gilead Sciences asserts either of these patents in an infringement suit, we may not be successful in convincing a trial court that the claims are invalid and unenforceable. In that circumstance, if we were selling or offering to sell the regimen of bemnifosbuvir and ruzasvir prior to the expiration of these Gilead Sciences patents, we would need to obtain a license from Gilead Sciences covering the then remaining term of the patents, which may not be available on reasonable terms, if at all. If such a license is required and we are unable to agree on license terms, a court may impose license terms, which could result in significant cost for the period we may be commercializing the product prior to the expiration of the patents held by Gilead Sciences.
Current wording
Many of our competitors have substantially greater capital resources, access to larger pools of capital, robust product candidate pipelines, established presence in the market, deep and broad commercial infrastructures and greater expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than we do. As a result, our competitors may be able to maintain market share or achieve product commercialization or patent or other intellectual property protection earlier than we can. For example, in each of May 2023 and October 2024, the US Patent and Trademark Office (“USPTO”) granted Gilead Sciences patents in the US that include claims which purportedly covers our compound bemnifosbuvir. While we believe the claims in these patents are invalid and unenforceable and will expire not later than June 15, 2028, if Gilead Sciences asserts either of these patents in an infringement suit, we may not be successful in convincing a trial court that the claims are invalid and unenforceable. In that circumstance, if we were selling or offering to sell BEM/RZR prior to the expiration of these Gilead Sciences patents, we would need to obtain a license from Gilead Sciences covering the then remaining term of the patents, which may not be available on reasonable terms, if at all. If such a license is required and we are unable to agree on license terms, a court may impose license terms, which could result in significant cost for the period we may be commercializing the product prior to the expiration of the patents held by Gilead Sciences.
Previous wording
In the US, third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. The Medicare program is increasingly used as a model for how private and other governmental payors develop their coverage and reimbursement policies for new drugs. However, no uniform policy for coverage and reimbursement for products exists among third-party payors in the US. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Some third-party payors may require pre-approval of coverage for new or innovative drug therapies before they will reimburse healthcare providers who use such therapies. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases on short notice, and we believe that changes in these rules and regulations are likely. We cannot predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.
Current wording
In the US, third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. The Medicare program is increasingly used as a model for how private and other governmental payors develop their coverage and reimbursement policies for new drugs. However, no uniform policy for coverage and reimbursement for products exists among third-party payors in the US. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to meet specified annual timelines set by certain payors for formulary inclusion decisions, in addition to providing scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Some third-party payors may require pre-approval of coverage for new or innovative drug therapies before they will reimburse healthcare providers who use such therapies. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases on short notice, and we believe that changes in these rules and regulations are likely. We cannot predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.
Previous wording
Currently, we anticipate to establish our own commercial organization in the US to commercialize, together with a collaborator, our HCV product candidate, if approved. Outside the US, we anticipate to rely on a collaborator to commercialize our HCV product candidate if approved. We do not currently have any commercialization arrangements in place with any collaborator either within or outside the US and we may be unable to enter into acceptable arrangements to do so.
Current wording
Currently, we anticipate to establish our own commercial organization for the purpose of commercializing in the US our HCV product candidate, if approved. Outside the US, we anticipate to rely on one or more collaborators to commercialize our HCV product candidate, if approved. We do not currently have any commercialization arrangements in place with any collaborator or other third parties either within or outside the US and we may be unable to enter into acceptable arrangements to do so.
Previous wording
If we are unable to establish adequate sales, marketing and distribution capabilities, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates and may not become profitable and may incur significant additional losses. We will be competing with many companies, including large pharmaceutical companies, including Gilead Sciences and AbbVie in HCV, that have extensive and well-funded marketing and sales operations. Without a robust internal team or the support of third-parties to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.
Current wording
If we are unable to establish adequate sales, marketing and distribution capabilities, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates and may not become profitable and may incur significant additional losses. We will be competing with many companies, including large pharmaceutical companies, and specifically Gilead Sciences and AbbVie in HCV, that have extensive and well-funded marketing and sales operations. Without a robust internal team or the support of third-parties to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.
Previous wording
If any of our product candidates is approved for commercialization, we currently anticipate to selectively partner with third parties to market such product both within and outside the US. If we or a collaborator market a product outside the US, we expect that we will be subject to additional risks related to international pharmaceutical operations, including but not limited to:
Current wording
If any of our product candidates are approved for commercialization outside the US, we currently anticipate to selectively partner with third parties to market such product in the territories in which approval has been obtained. In connection with the marketing of a product outside the US, we expect that we will be subject to additional risks related to international pharmaceutical operations, including but not limited to:
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Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
If our cash, cash equivalents and marketable securities are not sufficient to fund our future operations, we will need additional capital to fund these activities, which we may raise through equity offerings, additional term loans under the Loan and Security Agreement (to the extent we meet the required terms for remaining tranches), other debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or other sources. Additional sources of financing might not be available on favorable terms, if at all.
Current report — wording carried from elsewhere
Excluding the Loan and Security Agreement which provides for the draw of additional term loans subject to the satisfaction of certain terms and conditions which we have not yet satisfied, we do not currently have any committed external source of funds or other support and we cannot be certain that additional funding will be available on acceptable terms, if needed.
Current report — wording carried from elsewhere
Book, do not timely file a lawsuit in response to a certification from a generic company under an ANDA, or if we do not prevail in the resulting patent litigation, we can lose our proprietary protection, and our product can rapidly become generic. Further, even if we do correctly list our relevant patents in the Orange Book, bring a lawsuit in a timely manner and prevail in that lawsuit, the generic litigation may be at a very significant cost to us of attorneys’ fees and employee time and distraction over a long period. Further, it is common for more than one generic company to try to sell an innovator drug at the same time, and so we may be faced with the cost and distraction of multiple lawsuits. We may also determine it is necessary to settle the lawsuit in a manner that allows the generic company to enter our market prior to the expiration of our patent or otherwise in a manner that adversely affects the strength, validity or enforceability of our patent.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in Medicare, Medicaid, other US federal healthcare programs or healthcare programs in other jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations.
Previous report — wording carried elsewhere
Retaining qualified scientific, clinical and manufacturing personnel as well as recruiting qualified sales and marketing personnel if we elect to establish our own commercial organization will be critical to our success. Our ability to identify, hire and retain additional personnel and, if necessary, replace departed executive officers and key employees may be difficult or costly and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to discover or otherwise identify and develop product candidates and gain regulatory approval of and commercialize products successfully.
Previous report — wording carried elsewhere
These and other changes in stakeholder expectations may lead to increased costs as well as scrutiny that could heighten all of the risks identified in this risk factor. Additionally, our suppliers and business partners may be subject to similar expectations, which may augment or create additional risks, including risks that may not be known to us.