FPI-1966 / AstraZeneca - LARVOL DELTA

A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: Fusion Pharmaceuticals Inc. | Completed ➔ Terminated; Fusion announced that it is discontinuing this study as part of a portfolio prioritization and assessment; Fusion no longer plans to pursue development of FPI-1966.

Metastases • Trial termination • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Announces Third Quarter 2023 Financial Results and Clinical Program Updates (PRNewswire) - "The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability, and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R....Fusion is currently enrolling Cohort 2 in the cold/hot dosing regimen at 25 kBq/kg. The Company expects to report data from this cohort around year-end 2023....R&D Expenses: Research and development expenses for the third quarter of 2023 were $14.6 million, compared to $16.6 million for the same period in 2022. The decrease was primarily due to a decrease in FPI-1966 program-related activities as a result of the Company ceasing clinical development for the program and a decrease in manufacturing-related costs for our Phase 1 clinical trial of FPI-1434, partially offset by program expenses for our Phase 2 clinical trial of FPI-2265."

Commercial • Enrollment status • P1 data • Breast Cancer • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=6 | Completed | Sponsor: Fusion Pharmaceuticals Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Sep 2023 | Trial primary completion date: Jun 2026 ➔ Sep 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=6 | Active, not recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Recruiting ➔ Active, not recruiting | N=155 ➔ 6

Enrollment change • Enrollment closed • Metastases • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Fusion Pharmaceuticals Announces First Quarter 2023 Financial Results and Clinical Program Updates (PRNewswire) - "FPI-1434...The Company anticipates reporting a clinical data update from the Phase 1 trial in a poster presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting on Tuesday, June 27th from 12:30 – 2:00pm CT, followed by a webcast investor presentation (details to be provided)....Fusion announced that it is discontinuing the Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3. As part of a portfolio prioritization decision to focus resources on the Company's lead program, FPI-2265, and assessment of the relative portfolio value contributions of our clinical assets, Fusion no longer plans to pursue development of FPI-1966."

Discontinued • P1 data • Adrenal Cortex Carcinoma • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Liver Cancer • Lung Cancer • Melanoma • Ocular Melanoma • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • Uveal Melanoma

Fusion Pharmaceuticals Announces Fourth Quarter 2022 Financial Results and Clinical Program Updates (PRNewswire) - "The first cohort of the Phase 1 portion of this trial is designed to evaluate various doses of vofatamab ('cold antibody') to assess the impact of pre-dosing on tumor uptake and will inform the dosing regimen for the remainder of the trial. The Company anticipates providing a preliminary clinical data update in 2024....Fusion announced that it will present data from three preclinical studies in poster presentations at the American Association for Cancer Research (AACR) Annual Meeting being held in Orlando, Fla., April 14-19, 2023."

P1 data • Preclinical • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Reports Progress and Provides Recent Corporate Highlights (Canada Newswire) - "...'we expect to file an investigational new drug application (IND) for FPI-2068, our first novel TAT being developed in collaboration with AstraZeneca, in the first quarter of 2023.'....The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The first cohort of the Phase 1 portion of this study is designed to evaluate various doses of vofatamb ('cold antibody') to assess the impact of pre-dosing on tumor uptake and will inform the dosing regimen for the remainder of the study. The Company anticipates providing a clinical data update in 2024."

Enrollment status • IND • P1 data • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Second Quarter 2022 Financial Results and Clinical Program Updates (PRNewswire) - "FPI-1434: The Company anticipates reporting Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy; FPI-1966: Fusion expects to dose the first patient in the second half of 2022 and plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort following initial experience with patient screening in order to better predict the cadence of patient enrollment."

P1 data • P1/2 data • Trial status • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces First Patient Dosed in Phase 1/2 Study of FPI-1966 In Patients with Advanced Solid Tumors Expressing FGFR3 (PRNewswire) - "Fusion Pharmaceuticals Inc...announced that the first patient has been dosed in the Phase 1/2 study evaluating [225Ac]-FPI-1966 (FPI-1966) in patients with advanced solid tumors expressing fibroblast growth factor receptor three (FGFR3). FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab, a human monoclonal antibody that targets FGFR3, with actinium-225....Fusion plans to provide guidance on timing for preliminary pharmacokinetic, imaging and safety data following initial experience with patient screening via imaging with FPI-1967, in order to more accurately predict the cadence of patient enrollment."

Trial status • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Provides Updates on FPI-1434 and FPI-1966 Clinical Programs (PRNewswire) - "Fusion Pharmaceuticals Inc...announced updates on its Phase 1 clinical trial evaluating FPI-1434 as a monotherapy for the treatment of solid tumors expressing IGF-1R and its Phase 1 clinical trial evaluating FPI-1966 for the treatment of solid tumors expressing FGFR3. In the FPI-1434 trial, the Company now expects to report Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023, rather than in the second half of 2022. Fusion is also updating guidance for FPI-1966 and expects to dose the first patient in this study in the second half of 2022, rather than in the second quarter of 2022."

P1 data • Trial status • Oncology • Solid Tumor

"$FUSN FPI-1434 Phase 1 data delayed from 2H'22 to 1H'23. FPI-1966 dosing delayed from Q2 to 2H'22." (@BioStocks)

P1 data

A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=155 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc.

New P1/2 trial • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Fusion Pharmaceuticals Announces Third Quarter 2021 Financial Results and Clinical Program Update (PRNewswire) - "FPI-1434 Phase 1 multi-dose data now expected in 2H 2022; [for FPI-1966] Fusion expects to dose the first patient in the first quarter of 2022 and expects interim data from the first patient cohort in the first quarter of 2023. FPI-2059 investigational new drug application (IND) on track for first half 2022."

IND • New P1 trial • P1 data • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Presentation of Preclinical Data Supporting its FPI-1966 and FPI-2059 Targeted Alpha Therapies (PRNewswire) - "Fusion Pharmaceuticals...announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies (TATs) at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1....We are pleased to be advancing further preclinical studies of FPI-2059 as we approach an investigational new drug (IND) filing in the first half of 2022."

IND • Preclinical • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Second Quarter 2021 Financial Results and Business Update (Canada Newswire) - “FPI-1966…The Company anticipates initiating the Phase 1 study around the end of 2021 and reporting interim data from the first patient cohort around the end of 2022…R&D Expenses: Research and development expenses for the second quarter of 2021 were $21.1 million, compared to $3.3 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, asset purchase agreements and preclinical research and manufacturing costs.”

Commercial • New P1 trial • P1 data • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Oncology

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966, an Investigational Radiopharmaceutical for the Treatment of Head and Neck and Bladder Cancers Expressing FGFR3 (PRNewswire) - "Fusion Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3)...particularly head and neck and bladder cancers....Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose."

IND • New P1 trial • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Urothelial Cancer

Fusion Pharmaceuticals Announces First Quarter 2021 Financial Results and Business Update (PRNewswire) - "'We continue to advance our Phase 1 study of FPI-1434...In anticipation of data and determination of a recommended Phase 2 dose in the first half of 2022, we are amending the study protocol to define tumor-specific cohorts based upon IGF-1R expression and tumor uptake as seen to date in the Phase 1 study...In parallel, we are building a diverse pipeline of alpha-emitting radiopharmaceuticals. We expect to file our investigational new drug (IND) application for FPI-1966 in the second quarter of this year.'"

Clinical protocol • IND • P1 data • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Fourth Quarter 2020 Financial Results and Business Update (Canada Newswire) - "Fusion intends to utilize its expertise and IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an investigational new drug application in the first half of 2022; FPI-1434 Monotherapy: Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose/schedule, in the first half of 2022; Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy; FPI-1966: Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the second quarter of 2021."

IND • P1 data • Trial status • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Third Quarter 2020 Financial Results and Business Update (PRNewswire) - “…Fusion to begin the multi-dosing portion of the study at the next higher planned dose level. The Company expects to dose the first patient in the multi-dosing portion of the study in the fourth quarter of 2020…Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy…FPI-1966 is designed to target and deliver Actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the first half of 2021.”

Enrollment status • IND • Trial status • Bladder Cancer • Head and Neck Cancer • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Second Quarter 2020 Financial Results and Business Update (PRNewswire) - "FPI-1966 is designed to target and deliver Actinium to tumor sites expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 approximately six to twelve months after the Company fully resumes preclinical activities following interruptions caused by COVID-19."

IND • Preclinical • Bladder Cancer • Head and Neck Cancer • Oncology