bioAffinity Technologies, Inc.

Climate Impact & Sustainability Data (2022-09-30, 2023, 2024, 2024-09-30)

The ongoing COVID-19 pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; general instability of economic and political conditions in the United States, including inflationary pressures, increased interest rates, economic slowdown or recession, and escalating geopolitical tensions; compliance with government regulations, including environmental, health, and safety regulations and liabilities thereunder.

Jamie Platt, Ph.D., joined the bioAffinity Technologies Board of Directors in December 2023.
Sandeep Bansal, M.D., joined the Medical and Science Advisory Board in February 2024.
Lung Innovations Network incorporated CyPath® Lung into its practice in March 2024.

Long-term Goals:

Accelerate market presence of CyPath® Lung in Asia, Eastern Europe, and Australia after obtaining FDA marketing authorization.

Medium-term Goals:

Enter the EU market with CyPath® Lung as a CE-marked IVD test.
Conduct a pivotal clinical trial in the U.S. to seek FDA clearance of CyPath® Lung.

Short-term Goals:

Limited operating history makes it difficult to evaluate the current business and future prospects.
Requires additional financing to implement the business plan.
Substantial doubt about the ability to continue as a going concern due to current liquidity position.
Intense competition in the biotechnology and pharmaceutical industries.
Rapidly changing market for proposed tests and products.
Healthcare cost containment initiatives and the growth of managed care may limit returns.
Dependence on third parties for manufacturing, marketing, and clinical trials.
Potential product liability and pre-clinical and clinical liability risks.
Risks related to intellectual property rights.
Government regulations (FDA, CLIA, EU IVDR).
Cybersecurity threats.

Raising additional capital through equity or debt offerings, strategic relationships, or grants.
Developing and commercializing diagnostic tests and therapeutic products.
Expanding commercialization efforts.
Obtaining necessary regulatory approvals.
Establishing and managing collaborations.
Securing necessary personnel and infrastructure.
Developing strategic relationships.
Implementing a cyber risk management program.
Maintaining a CAP/CLIA-certified clinical pathology laboratory.
Obtaining product liability insurance.

GO2 Partners for patient collection kits, warehousing, and distribution services.

Added CyPath® Lung to the U.S. Federal Supply Schedule, providing access to the Veterans Health Administration and Military Health System.

Significant losses and negative cash flows from operations since inception.
Substantial doubt about the Company’s ability to continue as a going concern for at least twelve months.
Need to raise further capital to support future operations.

Consummated a registered direct offering and concurrent private placement offering, raising an additional $2.3 million in cash.