Risk Factors Update Summary

• Ongoing litigation challenging FDA approval of mifepristone may impact new drug development and distribution.
• Accumulated deficit increased from $210.1 million to $239 million, impacting financial stability.
• The U.S. Supreme Court granted petitions for certiorari for a district court decision.
• Net cash used in operating activities increased from $28.9 million to $31.7 million.
• The U.S. Court of Appeals held that changes allowing expanded access to mifepristone were arbitrary.
• Phase 2 clinical trial changed to Phase 2a RIVER trial for Haduvio, affecting development plans.
• The U.S. Supreme Court granted petitions for certiorari for the Court of Appeals' decision.
• Potential need for two additional Phase 3 clinical trials before NDA submission, impacting timelines.
• The U.S. Supreme Court granted petitions for certiorari for the Court of Appeals' decision.
• Cash, cash equivalents, and marketable securities decreased from $120.5 million to $83 million.
• The U.S. Supreme Court granted petitions for certiorari for the Court of Appeals' decision.
• Change from Phase 2b CORAL to Phase 2b CORAL clinical trial, affecting trial specifics.
• The U.S. Supreme Court granted petitions for certiorari for the Court of Appeals' decision.
• Change from HAL to HAP study, impacting study focus and characterization efforts.