FL-101 / Cypherpunk Technologies - LARVOL DELTA

Leap Therapeutics Acquires Flame Biosciences (PRNewswire) - "Leap Therapeutics, Inc....announced that the companies have entered into a definitive merger agreement pursuant to which Leap has acquired Flame and its assets, including FL-301, its clinical stage anti-Claudin18.2 monoclonal antibody, FL-302, its preclinical anti-Claudin18.2/CD137 bispecific monoclonal antibody, FL-501, its preclinical anti-GDF15 monoclonal antibody, and net cash of approximately $50 million as of December 31, 2022. The combined company will...remain focused on advancing DKN-01, Leap's anti-DKK1 monoclonal antibody, in Phase 2 clinical trials in gastric cancer, endometrial cancer, and colorectal cancer patients. The total cash balance of the combined company as of December 31, 2022 was approximately $115 million, expected to be sufficient to fund Leap's planned operating expenses and development plans for DKN-01, FL-301, and the preclinical programs to mid-2025."

Financing • M&A • Oncology

FL- 101 Study in Non-Metastatic MIBC (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Flame Biosciences | Not yet recruiting ➔ Withdrawn

Trial withdrawal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CRP

A Bioavailability Study of FL-101 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Flame Biosciences | Active, not recruiting ➔ Completed

Trial completion

Phase 0 Study of FL-101 in Non-Metastatic MIBC (clinicaltrials.gov) - P1 | N=5 | Not yet recruiting | Sponsor: Flame Biosciences

New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CRP

A Bioavailability Study of FL-101 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Flame Biosciences | Recruiting ➔ Active, not recruiting | N=40 ➔ 24

Enrollment change • Enrollment closed

FL-101 in Surgically Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Flame Biosciences; N=90 ➔ 0; Trial completion date: Feb 2023 ➔ Dec 2021; Recruiting ➔ Withdrawn; Trial primary completion date: Oct 2022 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CRP

A Bioavailability Study of FL-101 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Flame Biosciences; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

FL-101 in Surgically Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Flame Biosciences; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CRP

Phase 2 study of FL-101 in non-small cell lung cancer (clinicaltrialsregister.eu) - P2; N=90; Ongoing; Sponsor: Flame Biosciences

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CRP • IL1B • IL6

A Bioavailability Study of FL-101 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Flame Biosciences

New P1 trial