ADDED
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 69 9A.
Changes in regulatory requirements, policies and guidelines, including guidelines specifically addressing requirements for the development of treatments for RSV, type 2 immune and mast-cell-driven diseases or other virology and immunology indications could also delay the time required to reach regulatory approval of one or more of our product candidates.
B USINESS BUSINESS Overview We are a biotechnology company that uses our robust, chemistry-driven approach and drug discovery capabilities to discover and develop small molecule drugs for virology and immunology indications.
MAVYRET was also approved as the first and only treatment for acute HCV infection in June 2025.
hospitalization in young children and a significant cause of respiratory illness in older adults.
Populations at high risk for severe RSV infection include infants and young children, adults older than 65 years of age, and those with comorbidities such as chronic heart or lung disease.
Recent CDC estimates suggest a significant RSV burden in the U.S., with up to 6.5 million outpatient visits, 350,000 hospitalizations and 23,000 deaths annually.
We also have clinical-stage programs in virology for SARS-CoV-2, the virus that causes COVID-19, and Hepatitis B virus, or HBV, the most prevalent chronic hepatitis.
An overactive response is a primary driver of a number of inflammatory diseases for which there is an enduring unmet need including atopic dermatitis, or AD, urticarias, asthma, prurigo nodularis, or PN, chronic rhinosinusitis with nasal polyps, or CRSwNP, as well as some forms of chronic obstructive pulmonary disease, or COPD, and other conditions.
Based on industry reports, by 2030 the market is projected to be approximately $5 billion for urticaria, $30 billion for AD and $35 billion for the combined market of asthma, COPD, CRSwNP, and PN.
REMOVED
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 71 9A.
Changes in regulatory requirements, policies and guidelines, including guidelines specifically addressing requirements for the development of treatments for RSV, SARS-CoV-2 or other virology and immunology 1 indications could also delay the time required to reach regulatory approval of one or more of our product candidates.
B USINESS BUSINESS Overview We are a biotechnology company that uses our robust, chemistry-driven approach and drug discovery capabilities to discover and develop small molecule drugs with an emphasis on virology and immunology.
hospitalization in young children and a significant cause of respiratory illness in older adults, with estimates suggesting that on average each year RSV leads to three million hospitalizations globally in children under 5 years old and 177,000 hospitalizations in the U.S.
Our initial focus has been on mechanisms involved in an overactive type 2 immune response, which is the reaction of the body's immune system when the body detects infections or allergens and sends out immune cells to fight them.
An overactive response is a primary driver of a number of inflammatory diseases.
Our initial immunology targets involve the following mechanisms of immune response: The receptor tyrosine kinase, known as KIT, which is critical for regulating mast cell activity; and STAT6, a transcription factor uniquely responsible for interleukin-4 (IL-4)/interleukin-13 (IL-13) cell signaling, the factors that play important roles in regulating the responses of lymphocytes, myeloid cells, and non-hematopoietic cells within the immune system.
alone; and Atopic dermatitis, or AD, a chronic dermatological disease characterized by dry, red, inflamed, irritated and itchy skin with significant quality of life impacts such as leading a limited lifestyle, avoidance of social 3 interactions and a reduced range of activities, with AD affecting 7.3% of the US adult population, of whom ~40% have moderate to severe disease.
As of September 30, 2024, we had $248.2 million in cash, cash equivalents and short-term marketable securities.
We believe that our existing cash, cash equivalents, and short-term marketable securities as of September 30, 2024 as well as the cash flows from our retained portion of future HCV royalties will enable us to fund our operating expenses and capital expenditure requirements into fiscal 2027.