Clinical Trial Success Uncertainty: Inovio's product pipeline is subject to the inherent risks and uncertainties of clinical development, including the potential for unforeseen safety issues, lack of efficacy, or failure to meet primary endpoints, which could halt development or prevent market approval.

Regulatory Approval Hurdles: The company faces significant challenges in navigating complex and lengthy regulatory processes for its DNA vaccines and therapies, with past clinical holds and delays for its Cellectra delivery device highlighting the difficulty in securing necessary approvals from health authorities globally.

Capital Raising and Dilution: Developing pharmaceutical products is capital-intensive, and Inovio's continued operations depend on its ability to secure substantial additional financing, which may lead to significant dilution for existing shareholders through equity offerings or unfavorable debt terms.