Lantern Pharma gets Taiwan approvals to expand LP-300 Phase 2 trial

- The Taiwan FDA approved the amended protocol and the lead Taiwan site received IRB approval during September of 2026. -- The next stage (Part 2) is a single-arm study enrolling never-smoker patients with the EGFR exon 21 L858R mutation, with LP-300 dosing extended from six to a maximum of eight cycles. -- EGFR mutations are found in 55% of advanced lung adenocarcinomas in Taiwan and roughly half across Asia, compared with approximately 14% of NSCLC in Europe and 24% in the U.S.; the L858R mutation is also more common in Asian patients. -- In the U.S., a central IRB has approved the amended protocol and academic sites have begun identifying patients with the L858R mutation for enrollment. -- Lantern is exploring regional licensing, partnering and co-development opportunities for LP-300. DALLAS--()--October 07, 2026-- Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-driven precision oncology company, today announced that it has received regulatory and IRB approvals in Taiwan to open the next stage (Part 2) of its Phase 2 HARMONIC(TM) trial of LP-300. The Taiwan Food and Drug Administration (TFDA) approved the amended protocol earlier in September, and the lead Taiwan site received local Institutional Review Board (IRB) approval on September 29, 2026. The lead site is now open to accrual and actively screening patients. The approval also allows additional Taiwan sites to proceed with their own IRB reviews. Lantern anticipates IRB approval in an additional two sites during Q4. In the United States, a central IRB has approved the amended protocol, and academic clinical sites have begun identifying patients whose tumors carry the EGFR exon 21 L858R mutation. Patients enrolled under the amended protocol will be eligible for up to eight cycles of LP-300, which is an increase from the prior limit of up to six cycles. The increase to eight cycles is supported by two key findings: 1. Longer progression-free survival in patients completing more cycles -- In the ongoing Phase 2 trial, L858R patients who completed six cycles of LP-300 had a median progression-free survival (mPFS) of 8.9 months (n=9; three had not yet progressed), compared with 8.3 months for all L858R patients (n=16). These data are exploratory and need to be confirmed in additional patients. 2. Comparable safety with longer treatment -- In HARMONIC(TM), the safety profile of patients who received six cycles was comparable to that of patients who received four. Additionally, in prior clinical trials with LP-300, up to eight cycles at the current dose did not alter LP-300's safety profile. Taiwan: High Patient Population & Need Lung cancer has been the leading cause of cancer death in Taiwan for decades, and more than half of lung cancer patients there have never smoked.(1,2) According to Taiwan's 2025 national lung cancer treatment guidelines, 55% of Taiwanese patients with advanced lung adenocarcinoma harbor EGFR mutations, predominantly exon 19 deletions and exon 21 L85