Atossa Therapeutics (ATOS) risk factors, FY2025 10-K

Other

1. 01," under the heading "Significant disruptions in our information technology systems or breaches of data security could adversely affect our business"
2. 02ITE M 3. LEGAL PROCEEDINGS
3. 03ITEM 7. MAN AGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
4. 04Our business strategy is to advance our programs through clinical studies, including with potential partners, and opportunistically add programs in areas of high unmet medical need through acquisition, minority investment, collaboration or internal development
5. 05Summary of Our Leading Programs
6. 06potential role of estrogen signaling modulation in muscle preservation and inflammation associated with conditions, such as DMD and MAS, among others
7. 07The study fully enrolled in November 2023 and in September 2024, the primary objective measuring MBD after six months of treatment, was concluded. The data showed the potential of low-dose (Z)-endoxifen to significantly reduce MBD with a favorable safety profile
8. 08I-SPY 2 Endocrine Optimization Pilot Study
9. 09Duchenne Muscular Dystrophy
10. 10Commercial Lease Agreement
11. 11Critical Accounting Estimates
12. 12Research and Development Expenses
13. 13benefits, including bonus and non-cash stock-based compensation expense, based on an estimate of his total hours spent on research and development activities
14. 14Clinical Trial and Preclinical Study Accruals
15. 15Revenue and Cost of Revenue. For the years ended December 31, 2025 and 2024, we had no source of revenue and no associated cost of revenue
16. 16Clinical and pre-clinical trial expense increased $6.1 million for the year ended December 31, 2025 compared to the prior year due to an increase in spending for the (Z)-endoxifen trials, including an increase in drug development costs
17. 17The increase in R&D professional fees and other of $0.7 million for the year ended December 31, 2025 compared to the prior year was primarily attributable to higher regulatory consulting fees in 2025 related to our (Z)-endoxifen program
18. 18Interest Income. Interest income of $2.4 million for the year ended December 31, 2025 represented a decrease of $1.7 million compared to the prior year, and was due primarily to a decrease in the average funds invested in our money market account
19. 19Liquidity and Capital Resources
20. 20the costs and fees associated with the discovery, acquisition or license of additional product candidates or technologies
21. 21Off-Balance Sheet Arrangements
22. 22Evaluation of Disclosure Controls and Procedures
23. 23Management ’ s Annual Report on Internal Control Over Financial Reporting
24. 24Changes in Internal Control Over Financial Reporting
25. 25ITE M 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
26. 26ITE M 11. EXECUTIVE COMPENSATION
27. 27IT EM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
28. 28ITE M 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
29. 29Opinion on the Financial Statements
30. 30The Company's Ability to Continue as a Going Concern
31. 31Description of the Matter
32. 32We obtained an understanding of the Company’s clinical trials, its research and development contracts, and management’s process for estimating the accrued and prepaid research and development expenses
33. 33Loss on disposal of assets
34. 34NOTE 1: NATURE OF OPERATIONS
35. 35Cash and Cash Equivalents
36. 36Concentration of Credit Risk
37. 37Variable Interest Entities
38. 38Investments in Equity Securities
39. 39Standards Codification (ASC) 321, Investments – Equity Securities . At each reporting period, the Company performed an assessment to determine if it still qualified for this measurement alternative
40. 40The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements
41. 41Level 3: Unobservable inputs that cannot be corroborated by market data that reflects the reporting entity's own assumptions
42. 42Recently Adopted Accounting Pronouncements
43. 43Recently Issued Accounting Pronouncements
44. 44NOTE 4: INVESTMENT IN EQUITY SECURITIES
45. 45NOTE 5: PREPAID EXPENSES AND OTHER CURRENT ASSETS
46. 46NOTE 7: PAYROLL LIABILITIES
47. 47NOTE 8: RESEARCH AND DEVELOPMENT TAX REBATE LIABILITY
48. 48NOTE 9: FAIR VALUE OF FINANCIAL INSTRUMENTS
49. 49Series B Convertible Preferred Stock
50. 50Voting Rights. Except as otherwise provided in the certificate of designation or as otherwise required by law, the Series B convertible preferred stock has no voting rights
51. 51NOTE 11: NET LOSS PER SHARE
52. 52Change in valuation allowance
53. 53Other non-taxable income & disallowed expenses
54. 54Litigation and Contingencies
55. 55NOTE 14: STOCK BASED COMPENSATION
56. 56NOTE 15: DEFINED CONTRIBUTION PLAN
57. 57NOTE 17: SUBSEQUENT EVENT
58. 58# Indicates management contract or compensatory plan, contract or agreement