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Leap Therapeutics,(LPTX) Investor Presentation - Slideshow

DKN-01 Clinical Development - DKN-01 exhibits single-agent activity in three indications and is being explored in combinations with checkpoint inhibitors and chemotherapy[4, 13] - In first-line GEJ/GC, DKN-01 combined with tislelizumab and chemotherapy showed a 68% overall response rate (ORR) in the mITT population[21, 64] - In DKK1-high patients within the first-line GEJ/GC study, the ORR reached 90% with DKN-01, tislelizumab, and chemotherapy, and a median PFS of 113 months was observed[21, 23, 29, 64] - In second-line GEJ/GC, DKN-01 plus tislelizumab demonstrated a 27% ORR and 43% disease control rate (DCR) in anti-PD-1/PD-L1-naïve mITT patients[32] - In second-line GEJ/GC DKK1-high/PD-L1 vCPS ≥ 10 patients, DKN-01 plus tislelizumab achieved a 55% ORR and 73% DCR[32, 36] - DKN-01 monotherapy in 2L+ EEC showed a 25% ORR and 63% clinical benefit in DKK1-high patients, with a median PFS of 43 months compared to 18 months in DKK1-low patients[78, 82] Strategic Partnership with BeiGene - Leap Therapeutics has a strategic partnership with BeiGene, including a potential $10 million option exercise fee based on data from DKN-01 plus tislelizumab combination studies in gastric cancer[15] - The total potential option exercise, clinical, regulatory, and commercial milestones could reach $132 million[15] - Total payments to date from BeiGene amount to $1525 million, comprising a $3 million option fee and a $1225 million equity investment[15] Colorectal Cancer Development - Preclinical data suggests DKN-01 has additive activity with 5-FU chemotherapy and can overcome 5-FU resistance in colorectal cancer models[65, 68, 70] - DKN-01 also shows additive activity with anti-PD-1 antibodies in colorectal cancer models[65, 72]