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This Annual Report on Form 10-K includes statistical and other industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties as well as our own estimates of potential market opportunities.
All of the market data used in this Annual Report on Form 10-K involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data.
Industry publications and third-party research, surveys, and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information.
Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities.
While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions.
TRADEMARKS, TRADENAMES AND SERVICE MARKS This Annual Report on Form 10-K may include trademarks, tradenames and service marks that are the property of other organizations.
Solely for convenience, trademarks and tradenames referred to in this Annual Report on Form 10-K may appear without the and symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.
Overview We are a late-stage clinical biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biochemistry and virology to discover, develop and commercialize novel, orally administered antivirals to treat serious viral diseases.
Our current product candidate pipeline includes the regimen of bemnifosbuvir and ruzasvir which we believe has the potential to improve the current standard of care ( SOC ) for the treatment of patients with hepatitis C virus ( HCV ) infection and AT-587 which we believe has the potential to be the first direct-acting antiviral ( DAA ) for the treatment of patients, particularly immunocompromised patients, with chronic hepatitis E virus ( HEV ) infection.
HCV - Our Goal and our Program The objective of our HCV development program is to improve upon the current SOC by offering bemnifosbuvir and ruzasvir as a differentiated pan-genotypic protease inhibitor-free, short-duration regimen for patients infected with HCV, if successfully developed and approved.
REMOVED
Overview We are a clinical-stage biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biology, biochemistry and virology to discover and develop novel orally administered product candidates to treat serious viral diseases.
Our lead product candidate is a regimen consisting of bemnifosbuvir and ruzasvir which we are developing for the treatment of chronic hepatitis C virus ( HCV ) infection.
Currently, we expect to commence enrollment of patients in an HCV Phase 3 program evaluating the regimen in April 2025.
HCV HCV is a blood-borne, positive-sense, single-stranded ribonucleic acid ("RNA") virus that primarily infects liver cells.
HCV is a leading cause of chronic liver disease, liver transplants and liver cancer in the US, Europe and Japan.
Despite the availability of direct-acting antiviral ( DAA ) oral combination treatment regimens and eradication efforts by the World Health Organization ("WHO") and others, HCV continues to be a serious viral disease.
An estimated 50 million people globally live with chronic HCV infection, with approximately 1 million new infections occurring each year.
These deaths are primarily attributable to cirrhosis and hepatocellular cancer, each of which are serious long-term consequences resulting from prolonged exposure, generally up to 20 years of HCV infection.
In the US, it is estimated that there are between 2.4 and 4.0 million persons with untreated HCV infection.
Further it is reported that on an annual basis in the US, there are greater than 160,000 newly reported HCV infections.