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If the FDA’s operational capacity continues to be reduced or if further policy changes are implemented that affect the agency’s review processes, our business, financial condition, and results of operations could be materially and adversely affected.
+Added: Artificial intelligence is playing an increasingly important role in biotechnology which may have an effect on us.
+Added: Artificial intelligence (“AI”) is increasingly playing a role in our industry, being used for target identification, drug discovery, preclinical modeling, and data analysis.
+Added: While it is not a significant factor in our current operations, AI may play a future role in our operations based upon our evaluation of its usefulness to us, and there are material risks associated with its use.
+Added: AI technologies are inherently complex and evolving.
+Added: They may not function as intended, produce accurate results, or provide actionable insights.
+Added: The quality of AI outputs depends heavily on the quality and quantity of input data, which in the life sciences context may be limited, biased, incomplete, or subject to regulatory and privacy constraints.
+Added: If we utilize AI in the future and our AI systems fail to identify viable therapeutic candidates, predict biological outcomes, or produce reproducible results, our product development efforts may be delayed or unsuccessful.
+Added: In addition, the use of AI in regulated environments such as biotechnology and pharmaceuticals may attract increasing scrutiny from regulatory authorities.
+Added: Regulatory bodies have not yet established clear guidelines governing the validation, approval, or oversight of AI-generated insights or AI-supported decision-making.
+Added: Any failure to comply with future regulatory expectations regarding AI could limit our ability to use such technologies or result in penalties or delays.
+Added: We also rely on third-party AI platforms, vendors, and cloud infrastructure.
+Added: Any errors, outages, security breaches, or failures by such third parties may disrupt our operations or compromise proprietary data.
+Added: Furthermore, as AI technologies become more widely adopted, we may face increased competition from other biotechnology companies leveraging similar tools.
+Added: If we are unable to successfully integrate and manage AI within our business, or if AI fails to deliver the expected benefits, our ability to discover and develop new therapies could be materially adversely affected.
Unregistered Sales of Equity Securities and Use of Proceeds.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.