Aankondiging • Jun 18
Fusion Pharmaceuticals Files Form 15 Fusion Pharmaceuticals Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. Aankondiging • May 11
Fusion Pharmaceuticals Inc. Announces First Patient Dosed in the Phase 2 Portion of the AlphaBreak Trial Evaluating FPI-2265 in Metastatic Castration-Resistant Prostate Cancer Fusion Pharmaceuticals Inc. announced that the first patient has been dosed in the Phase 2 portion of the AlphaBreak trial evaluating FPI-2265 (225Ac-PSMA I&T) in patients with metastatic castration-resistant prostate cancer (mCRPC). The AlphaBreak trial is a Phase 2/3, randomized, open-label, multicenter study to evaluate the safety and efficacy of FPI-2265 in patients with mCRPC previously treated with 177Lu-PSMA radiotherapy. The Phase 2 dose optimization portion is designed to evaluate whether there are added safety and/or efficacy benefits of two alternative dosing regimens in comparison to the previously studied regimen of 100 kBq/kg every eight weeks. The Phase 2 portion of the AlphaBreak trial is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the U.S. Food and Drug Administration (FDA), the Phase 3 global registration portion of the AlphaBreak trial will enroll approximately 550 patients and is expected to begin in 2025. FPI-2265 is an actinium-225 based PSMA targeting RC, for mCRPC, currently in a Phase 2 trial. Actinium-225 emits alpha particles and holds the promise of being a next-generation radioisotope in cancer treatment. By delivering a greater radiation dose over a shorter distance, alpha particles such as actinium-225 have the potential for more potent cancer cell killing, and targeted delivery, thereby minimizing damage to surrounding healthy tissue. Reported Earnings • May 08
First quarter 2024 earnings released: US$0.40 loss per share (vs US$0.45 loss in 1Q 2023) First quarter 2024 results: US$0.40 loss per share. Net loss: US$33.7m (loss widened 39% from 1Q 2023). Revenue is forecast to grow 44% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Reported Earnings • Mar 21
Third quarter 2023 earnings released: US$0.25 loss per share (vs US$0.55 loss in 3Q 2022) Third quarter 2023 results: US$0.25 loss per share (improved from US$0.55 loss in 3Q 2022). Net loss: US$17.3m (loss narrowed 28% from 3Q 2022). Revenue is forecast to grow 52% p.a. on average during the next 4 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 35% per year but the company’s share price has only increased by 25% per year, which means it is significantly lagging earnings growth. Aankondiging • Mar 21
AstraZeneca AB entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc. (NasdaqGS:FUSN) for $1.8 billion. AstraZeneca AB entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc. (NasdaqGS:FUSN) for $1.8 billion on March 18, 2024. Under the terms of the definitive agreement, AstraZeneca, through a subsidiary, will acquire all of Fusion's outstanding shares pursuant to a plan of arrangement for a price of $21.00 per share in cash at closing plus a non-transferable contingent value right of $3.00 per share in cash payable upon the achievement of a specified regulatory milestone. The upfront cash portion of the consideration represents a transaction value of approximately $2 billion. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $2.4 billion. Fusion will become a wholly owned subsidiary of AstraZeneca, with operations continuing in Canada and the US. . The sell-side termination fee equals $71.68 million and the buy-side termination fee equals $102.4 million. The transaction is subject to customary closing conditions, including the approval of Fusion shareholders and regulatory clearances. The transaction is expected to close in Q2, 2024. Centerview Partners LLC acted as financial advisor to Fusion. Mitchell Bloom, Stuart Cable, Blake Liggio and Amanda Gill of Goodwin Procter LLP acted as legal advisor to Fusion. Chad Bayne, Alex Gorka and Brett Anderson of Osler, Hoskin & Harcourt LLP acted as legal advisor to Fusion. Centerview Partners LLC acted as fairness opinion provider to Fusion. Sebastian L. Fain and Oliver J. Board of Freshfields Bruckhaus Deringer US LLP acted as legal advisor to AstraZeneca. Cheryl Satin, Michael Gans and Markus Viirland of Blake, Cassels & Graydon LLP acted as legal advisor to AstraZeneca. Equiniti Trust Company, LLC acted as depository bank to Fusion. Major Estimate Revision • Mar 21
Consensus EPS estimates fall by 11% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$1.35 to -US$1.50 per share. Revenue forecast of US$767.6k unchanged since last update. Biotechs industry in the US expected to see average net income decline 8.5% next year. Consensus price target up from US$14.27 to US$21.39. Share price rose 127% to US$21.20 over the past week. Price Target Changed • Mar 19
Price target increased by 34% to US$18.80 Up from US$14.00, the current price target is an average from 10 analysts. New target price is 11% below last closing price of US$21.18. The company is forecast to post a net loss per share of US$1.41 next year compared to a net loss per share of US$2.00 last year. Price Target Changed • Jan 29
Price target increased by 7.5% to US$14.27 Up from US$13.27, the current price target is an average from 11 analysts. New target price is 24% above last closing price of US$11.50. Stock is up 270% over the past year. The company is forecast to post a net loss per share of US$1.40 next year compared to a net loss per share of US$2.00 last year. Major Estimate Revision • Nov 14
Consensus revenue estimates increase by 266% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$570.0k to US$2.10m. Forecast losses expected to reduce from -US$1.66 to -US$1.45 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$13.10 unchanged from last update. Share price fell 10% to US$4.03 over the past week. Reported Earnings • Nov 09
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$0.25 loss per share (improved from US$0.55 loss in 3Q 2022). Net loss: US$17.3m (loss narrowed 28% from 3Q 2022). Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 38%. Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 35% per year but the company’s share price has fallen by 31% per year, which means it is significantly lagging earnings. Aankondiging • Oct 17
Fusion Pharmaceuticals Inc. Announces Board Changes Fusion Pharmaceuticals Inc. announced the appointment of Jeremy Bender, Ph.D., M.B.A., Teresa Bitetti, M.B.A., and David Meek to its Board of Directors, effective October 16, 2023. Dr. Bender, Ms. Bitetti and Mr. Meek succeed Johan Christenson, Ph.D., Chau Khuong and Heather Preston, M.D., who will step down from Fusion's Board effective October 16, 2023. Dr. Jeremy Bender is currently Chief Executive Officer of Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company focused on pediatric cancer. Previously, Dr. Bender served as Vice President of Corporate Development atGilead Sciences, overseeing acquisitions, partnerships and investments. He also served as Chief Operating Officer at Tizona Therapeutics, Chief Business Officer at Sutro Biopharma, and Vice President of Corporate Development at Allos Therapeutics, and began his career at Boston Consulting Group in the life sciences practice. He currently sits on the Board of Mereo BioPharma as an Independent Board Member.Dr. Bender holds a B.S. in Biological Sciences from Stanford University, a Ph.D. in Microbiology and Immunology from the University of Colorado and an M.B.A. from the MIT Sloan School of Management. Ms. Teresa Bitetti currently serves as President of the Global Oncology Business Unit of Takeda. Previously, Ms. Bitetti held various roles of increasing responsibility at Bristol-Myers Squibb Company (BMS), including as Senior Vice President, Head of Worldwide Oncology Commercialization. At BMS, she also served as Senior Vice President and Head of the U.S. Oncology business, President and General Manager of BMS Canada, and Worldwide Head of the BMS Virology business. Before BMS, Ms. Bitetti also held various roles of increasing responsibility at Mobil Oil Corporation. Ms. Bitetti currently serves on the board of Osmol Therapeutics as an independent director. Ms. Bitetti holds a B.A. from Wellesley College and an M.B.A. from the Darden School of Business at the University of Virginia. Mr. David Meek most recently served as Chief Executive Officer and Member of the Board of Directors of Mirati Therapeutics. Prior to this role, he served as the President, CEO and Board Member of FerGene and CEO and Board Member of Ipsen. Mr. Meek was previously an Executive Vice President and President of Oncology at Baxalta Incorporated in the leadup to the acquisition by Shire and Chief Commercial Officer of Endocyte, and he held executive leadership roles at Novartis Pharmaceuticals Corporation and Novartis Oncology. Mr. Meek has served on the boards of Pharmaceutical Research &Manufacturers of America and European Federation of Pharmaceutical Industries &Associations. He currently serves on the Board of Directors of uniQure N.V. and previously served on the Board of Directors of Entasis Therapeutics (acquired by Innoviva). Mr. Meek holds a B.A. from the University of Cincinnati. Aankondiging • Oct 13
Fusion Pharmaceuticals Inc. Announces Presentation of Preclinical Data Supporting FPI-2068, A Novel Targeted Alpha Therapy for EGFR-cMET Expressing Cancers Fusion Pharmaceuticals Inc. announced the presentation of preclinical data for FPI-2068, a clinical stage bispecific IgG-based targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that co-express EGFR-cMET. Fusion is jointly developing FPI-2068 with AstraZeneca under the companies' multi-asset collaboration agreement. The data are being presented in a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 11-15 in Boston, Massachusetts. In the preclinical study, FPI-2068 demonstrated anti-tumor efficacy in colorectal and lung tumor xenograft mouse models, and single dose administration of FPI-2068 led to prolonged tumor regression. Further, FPI-2068 caused activation of the DNA damage response (DDR) pathway as well as apoptosis, suggesting an inability of the cellular machinery to repair the DNA damage induced by the alpha radiation, consistent with the proposed primary mechanism of action. These data provide further evidence supporting the clinical development of FPI-2068, which is expected to enter a Phase 1 study for the treatment of solid tumors co-expressing EGFR-cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. Major Estimate Revision • Oct 13
Consensus revenue estimates increase by 160% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$220.0k to US$570.0k. EPS estimate unchanged at -US$1.66. Biotechs industry in the US expected to see average net income decline 4.2% next year. Consensus price target of US$13.10 unchanged from last update. Share price rose 7.8% to US$3.72 over the past week. New Risk • Oct 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m (US$368k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$159m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Major Estimate Revision • Aug 31
Consensus revenue estimates increase by 304% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$60.0k to US$240.0k. EPS estimate unchanged at -US$1.68. Biotechs industry in the US expected to see average net income decline 6.4% next year. Consensus price target broadly unchanged at US$13.11. Share price fell 3.0% to US$2.96 over the past week. Major Estimate Revision • Aug 15
Consensus revenue estimates fall by 91% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$640.0k to US$60.0k. Forecast losses increased from -US$1.65 to -US$1.68 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target of US$13.22 unchanged from last update. Share price was steady at US$3.06 over the past week. Reported Earnings • Aug 08
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: US$0.38 loss per share. Net loss: US$25.2m (loss widened 32% from 2Q 2022). Revenue missed analyst estimates by 60%. Earnings per share (EPS) exceeded analyst estimates by 2.6%. Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Aankondiging • Jun 28
Fusion Pharmaceuticals Inc. to Present Interim Data from Phase 1 Trial of FPI-1434 in Patients with Solid Tumors Expressing IGF-1R Fusion Pharmaceuticals Inc. announced the presentation of interim data from the dose escalation portion of the Phase 1 trial of [Ac]-FPI-1434 (FPI-1434) in patients with solid tumors expressing IGF-1R. The data will be presented by Neeta Pandit-Taskar, M.D., of Memorial Sloan Kettering Cancer Center, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting and will include molecular imaging, safety and pharmacokinetics (PK) from two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. 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. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. As part of the precision medicine approach, prior to receiving the therapeutic injection of FPI-1434, patients are administered an indium-111 imaging analogue, [In]-FPI-1547 (FPI-1547). The images collected are used to confirm the presence of tumor uptake and ensure that estimated radiation doses to organs and tissues are below protocol-specified safety limits. Based on results from an imaging sub-study evaluating pre-administration of cold antibody prior to each dose of FPI-1547 that demonstrated a favorable gain in tumor lesion uptake versus normal tissue, the Company amended the Phase 1 trial protocol to evaluate both the hot only and cold/hot dosing regimens. Cold/Hot Dosing Regimen: In the cold/hot arm, three patients were dosed in Cohort 1 at a dose of 15 kBq/kg following pre-administration of cold antibody. In Cohort 1, cold/hot dosing was observed to be safe with no treatment-related serious adverse events (SAEs) or dose limiting toxicities (DLTs). Absorbed dose to critical organs (kidney, liver and lungs) in this dosing regimen were less than 7% of defined limits, supporting continued dose escalation. Pre-administration of cold antibody demonstrated improved tumor uptake while also reducing hematological toxicity observed in the hot only dosing arm. When normalized to 15 kBq/kg, the average lesion absorbed dose and dose/volume in the cold/hot arm were nearly double the level compared to hot only. Further, 15 kBq/kg in the cold/hot dosing arm shows comparable systemic exposure to approximately 40 kBq/kg of a hot only dose, but shows an improved hematological safety profile as measured by changes in platelet count. Two heavily pre-treated patients from the cold/hot dosing arm received three and five cycles of treatment, with both achieving durable stable disease as their best response. The dose level from Cohort 1, while sufficient to demonstrate marked differences in tumor uptake and achieve stable disease, was expected to be sub-optimal with respect to efficacy. Fusion is currently enrolling Cohort 2 in the cold/hot dosing regimen at 25 kBq/kg and expects to report data from this cohort around year-end 2023. Hot Only Dosing Regimen: In the hot only multiple ascending arm, six patients were dosed across two cohorts. Dose-dependent decrease in blood counts, particularly thrombocytopenia, was identified as the most common type of adverse event related to FPI-1434, with Grade 4 thrombocytopenia observed at 75 kBq/kg and 55 kBq/kg. The Company has discontinued dosing in the hot only dosing arm and no longer plans to use this method of FPI-1434 administration. Major Estimate Revision • Jun 22
Consensus revenue estimates increase by 289% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$180.0k to US$710.0k. Forecast losses expected to reduce from -US$1.75 to -US$1.72 per share. Biotechs industry in the US expected to see average net income decline 85% next year. Consensus price target down from US$14.00 to US$13.25. Share price fell 2.8% to US$4.51 over the past week. New Risk • Jun 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 59% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m (US$904k revenue). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$159m net loss in 3 years). Aankondiging • May 12
Fusion Pharmaceuticals Inc. announced that it expects to receive $20 million in funding from Federated Hermes, Inc. Fusion Pharmaceuticals Inc. announced that it has entered into a securities purchase agreement with funds associated with Federated Hermes, Inc. to issue 4,784,689 of its common shares at an issue price of $4.18 per share for the gross proceeds of $20 million on May 10, 2023. The offering is expected to close on or about May 15, 2023, subject to the satisfaction of certain customary closing conditions. Aankondiging • Feb 15
Fusion Pharmaceuticals to Acquire Phase 2 Program for 225Ac-PSMA I&T Fusion Pharmaceuticals Inc. announced the acquisition from RadioMedix Inc. (‘RadioMedix’) of the investigational new drug application (‘IND’) for an ongoing Phase 2 clinical trial (the ‘TATCIST’ trial) evaluating (225) Ac-PSMA I&T, a small molecule targeting prostate specific membrane antigen (‘PSMA’) expressed on prostate cancers. Following the closing, the alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial will be known as FPI-2265. The TATCIST trial is designed to evaluate patients with metastatic castration-resistant prostate cancer (‘mCRPC’) with progressive disease, including patients who are naïve to PSMA targeted radiopharmaceuticals and those who have been pre-treated with (177) Lu-based PSMA radiopharmaceuticals such as PLUVICTO(TM). The trial is expected to evaluate approximately 100 patients with four treatment cycles per patient occurring every eight weeks. Patients are initially dosed at 100 kBq/kg with dose de-escalation possible based on biochemical response. Efficacy will be assessed using change in PSA levels and radiographic response. Fusion plans to expand the Phase 2 program to additional sites and expects to report data on 20 to 30 patients in the first quarter of 2024. Aankondiging • Jan 27
Fusion Pharmaceuticals Inc., Annual General Meeting, Jun 14, 2023 Fusion Pharmaceuticals Inc., Annual General Meeting, Jun 14, 2023. Price Target Changed • Nov 16
Price target decreased to US$13.95 Down from US$16.14, the current price target is an average from 6 analysts. New target price is 555% above last closing price of US$2.13. Stock is down 67% over the past year. The company is forecast to post a net loss per share of US$2.00 next year compared to a net loss per share of US$1.90 last year. Aankondiging • Nov 08
Fusion Pharmaceuticals Appoints Dmitri Bobilev as Chief Medical Officer Fusion Pharmaceuticals Inc. announced the appointment of Dmitri Bobilev, M.D., as chief medical officer.Dr. Bobilev joins Fusion from Checkmate Pharma, where he was vice president, head of clinical development untilthe company's acquisition by Regeneron earlier in 2022. At Checkmate, he was responsible for clinicaldevelopment strategy for vidutolimod. Prior to Checkmate, Dr. Bobilev was vice president, head of clinicaldevelopment at Vedanta Biosciences. He previously held clinical development leadership roles with Tesaro andSanofi. Dr. Bobilev spent more than 10 years as a practicing medical and radiation oncologist. Aankondiging • Aug 30
Fusion Pharmaceuticals Inc. Announces First Patient Dosed in Phase 1/2 Study of FPI-1966 in Patients with Advanced Solid Tumors Expressing FGFR3 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. The Phase 1/2 multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-1966 in patients with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumors. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake and pharmacokinetics. As part of the trial, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who upon imaging meet predefined tumor uptake will go on to receive FPI-1966. The Phase 2 portion of the study will consist of two tumor-specific cohorts and one basket cohort. 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. FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including bladder, ovarian and head and neck cancers. FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab, a human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated. Recent Insider Transactions • Aug 12
Independent Director recently bought US$90k worth of stock On the 11th of August, Steven Gannon bought around 44k shares on-market at roughly US$2.03 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$185k more in shares than they have sold in the last 12 months. Price Target Changed • Jul 06
Price target decreased to US$16.14 Down from US$18.20, the current price target is an average from 5 analysts. New target price is 530% above last closing price of US$2.56. Stock is down 68% over the past year. The company is forecast to post a net loss per share of US$2.09 next year compared to a net loss per share of US$1.90 last year. Aankondiging • Jun 24
Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-2059, an Investigational Small Molecule-Based Radiopharmaceutical Targeting Solid Tumors Expressing NTSR1 Fusion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) applications for [225Ac]-FPI-2059 (FPI-2059) and the corresponding imaging analogue [111In]-FPI-2058 (FPI-2058). FPI-2059 is a targeted alpha therapy (TAT) designed to use a small molecule to target and deliver actinium-225 to tumor sites expressing neurotensin receptor 1 (NTSR1), a protein that is overexpressed in multiple solid tumor types, including colorectal, pancreatic, gastric, neuroendocrine differentiated prostate, head and neck squamous cell carcinoma, and Ewing sarcoma cancers. Fusion acquired [177Lu]-IPN-1087 (IPN-1087), a lutetium-based beta-emitting radiopharmaceutical, from Ipsen in April 2021, and converted the compound to the alpha-emitting [225Ac]-FPI-2059. In clinical studies, IPN-1087 showed promising early safety data and good uptake in multiple tumor types. In a head-to-head in vivo comparison of therapeutic efficacy in a mouse xenograft model of colorectal cancer between FPI-2059 and IPN-1087, results show tumor regression with FPI-2059 is achieved at doses of approximately 1500 times lower than IPN-1087. Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing NTSR1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The study will prioritize six solid tumor indications, including head and neck squamous cell carcinoma, pancreatic, neuroendocrine prostate, colorectal, gastric and Ewing sarcoma. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-2059. As part of the screening process, patients will be administered an imaging analogue of FPI-2059, FPI-2058, and only those who meet predefined tumor uptake and safety criteria will go on to receive FPI-2059. Radiopharmaceuticals are a precision medicine in that the alpha therapeutic can be converted into a corresponding imaging analogue with a different radionuclide (in this case indium), used to screen for a biomarker in patients with tumors that express the cancer target, increasing the likelihood of response to therapy. Fusion plans to provide additional guidance on timelines for the FPI-2059 program following initial experience with patient screening in order to better predict the cadence of patient enrollment. FPI-2059 (FPI-2059) is a targeted alpha therapy combining actinium-225 with a small molecule designed to target neurotensin receptor 1 (NTSR1), in development as a potential treatment for various solid tumors. NTSR1 is a promising target for cancer treatment that is overexpressed in multiple solid tumors including colorectal, pancreatic, gastric, neuroendocrine differentiated prostate, head and neck squamous cell carcinoma and Ewing sarcoma cancers. FPI-2059 is currently being evaluated in a Phase 1 study. Aankondiging • Jun 15
Fusion Pharmaceuticals Presents Imaging Data from Cold Antibody Sub-Study in the Phase 1 Study of FPI-1434 Fusion Pharmaceuticals Inc. announced the presentation of imaging data from the "cold antibody sub-study" evaluating pre-administration of cold antibody (naked antibody without the isotope) prior to administration of the imaging agent (antibody with the isotope) in the Phase 1 study of FPI-1434 for the treatment of solid tumors expressing IGF-1R. The cold antibody sub-study was conducted concurrently with the dose escalation portion of the Phase 1 study of FPI-1434 for the treatment of solid tumors. The sub-study was designed to determine the safety, tolerability, and effect of administration of varying doses of FPI-1175, the naked antibody without the isotope, or "cold antibody", on the biodistribution, dosimetry and tumor uptake of [111In]-FPI-1547, the investigational imaging agent. Imaging data from the study demonstrate a favorable gain in [111In]-FPI-1547 tumor lesion uptake versus normal tissue when FPI-1175 was pre-administered and compared to dosing with FPI-1547 alone. Importantly, sites of improved tumor lesion uptake were independent of anatomic location of disease and included bone, lung, liver, and lymph nodes. Administration of FPI-1547 with and without pre-administration of FPI-1175 was safe without any drug-related Serious Adverse Events or Dose Limiting Toxicities. Pre-administration of FPI-1175 at 0.5 mg/kg is currently being evaluated with increasing dose levels of FPI-1434 in the ongoing Phase 1 study. Aankondiging • Jun 10
Fusion Pharmaceuticals Inc. Provides Updates on FPI-1434 and FPI-1966 Clinical Programs 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. Overview of FPI-1434 Phase 1 Clinical Trial. In the Phase 1 study, Fusion is exploring various dosing levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibodyis administered prior to each dose of FPI-1434. Data observed from a completed cold-antibody sub-study demonstrate the potential of pre-dosing cold antibody prior to FPI-1434 to increase the tumor to non-tumor distribution ratio of the radiopharmaceutical and thereby potentially improve the therapeutic window. As a result, Fusion initiated the dosing regimen evaluating pre-administration of cold antibody prior to FPI-1434 following a protocol amendment to the ongoing Phase 1 study of FPI-1434. Fusion expects to present more detailed data from the cold-antibody sub-study at the Society of Nuclear Medicine and Medical Imaging 2022 Annual Meeting taking place in Vancouver, British Columbia from June 11-14, 2022. Given the protocol amendment to include the dosing regimen evaluating pre-administration of cold-antibody and the time required to generate sufficient data to be able to provide information on both dosing paradigms, as well as ongoing enrollment challenges relating to staffing and resourcing issues at trial sites, and additional review boards required at trial sites for novel alpha-emitting radiopharmaceuticals, Fusion 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. Overview of FPI-1966 Phase 1 Clinical Trial: The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose, has been initiated. The first cohort in this study will comprise four sub-groups in which various doses of non-radiolabeled vofatamab will be evaluated to assess the impact of pre-dosing on tumor uptake. As previously disclosed, Fusion experienced initial challenges with study site initiations and is further experiencing enrollment challenges similar to the FPI-1434 study, including study backlogs as COVID-19 headwinds ease, staffing shortages at trial sites, and additional review boards required at trial sites for novel alpha-emitting radiopharmaceuticals. As a result, Fusion now expects to dose the first patient in the FPI-1966 Phase 1 study in the second half of 2022. In addition, Fusion plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort once patient enrollment begins. Major Estimate Revision • May 17
Consensus revenue estimates fall by 84% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$3.60m to US$590.0k. Forecast losses increased from -US$1.81 to -US$2.04 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target broadly unchanged at US$18.20. Share price fell 3.0% to US$4.00 over the past week. Aankondiging • Apr 14
Fusion Pharmaceuticals Inc. Announces Executive Changes On April 11, 2022, James O'Leary, M.D. tendered his resignation as Chief Medical Officer of Fusion Pharmaceuticals Inc. (the Company") effective June 30, 2022 (Exit Date"). Effective immediately, Dr. Joanne Schindler, who currently serves as Vice President, Medical Director, has been promoted to Executive Vice President, Medical Director & Clinical Development. Dr. O'Leary is expected to transition to Dr. Schindler full responsibility for all of the Company's clinical trials and for the day-to-day operations of the clinical and regulatory functions prior to his Exit Date. Price Target Changed • Feb 03
Price target decreased to US$18.20 Down from US$20.25, the current price target is an average from 5 analysts. New target price is 142% above last closing price of US$7.53. Stock is down 34% over the past year. The company is forecast to post a net loss per share of US$1.98 next year compared to a net loss per share of US$3.62 last year. Aankondiging • Jan 11
Fusion Pharmaceuticals Announces Nomination of First Targeted Alpha Therapy Candidate in Collaboration with AstraZeneca to Advance into IND-Enabling Studies for Phase 1 Development Fusion Pharmaceuticals Inc. announced nomination of the first targeted alpha therapy (TAT) candidate under the Company's collaboration agreement with AstraZeneca. Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion's Fast-Clear™ linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225. Under the terms of the previously announced collaboration agreement, Fusion will be operationally responsible for preclinical development through first-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development. IND enabling studies are ongoing. Price Target Changed • Nov 11
Price target decreased to US$19.00 Down from US$21.67, the current price target is an average from 4 analysts. New target price is 184% above last closing price of US$6.70. Stock is down 50% over the past year. The company is forecast to post a net loss per share of US$2.22 next year compared to a net loss per share of US$3.62 last year. Price Target Changed • Aug 18
Price target decreased to US$21.33 Down from US$23.00, the current price target is an average from 3 analysts. New target price is 156% above last closing price of US$8.33. Stock is down 34% over the past year. Major Estimate Revision • Aug 12
Consensus revenue estimates fall to US$173.7k The consensus outlook for revenues in 2021 has deteriorated. 2021 revenue forecast decreased from US$56.3m to US$173.7k. Forecast losses increased from -US$1.65 to -US$2.26 per share. Biotechs industry in the US expected to see average net income decline 21% next year. Consensus price target of US$23.00 unchanged from last update. Share price rose 3.1% to US$8.26 over the past week. Aankondiging • Jun 15
Fusion Pharmaceuticals Announces Preliminary Safety and Dosimetry Results from its Single-Dose Portion of the Phase 1 Study of FPI-1434 Fusion Pharmaceuticals Inc. announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion's targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (225Ac) to targeted tumor cells. In both the oral session and the poster titled, "Preliminary Dosimetry Results from a First-in-Human Phase 1 Study Evaluating the Efficacy and Safety of [225Ac]-FPI-1434 in Patients with IGF-1R Expressing Solid Tumors," results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for [225Ac]-FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40 kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits. The single dose escalation portion of the study has concluded, while enrollment into the multi-dosing cohorts are ongoing. FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion's Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties. Fusion presented preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib. The combination of the two therapeutics, using doses that were non-effective as single agents, resulted in anti-tumor efficacy against colorectal and non-small cell lung cancer tumor models. The strongest combination effect appeared to occur at the lowest single agent doses, as FPI-1434's efficacy dominated at higher dose levels.
Fusion also presented preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong "vaccine" effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells. Major Estimate Revision • May 19
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 expected loss increased from -US$1.25 to -US$1.65 per share. Revenue forecast of US$45.0m unchanged since last update. Biotechs industry in the US expected to see average net income decline 8.7% next year. Consensus price target down from US$22.75 to US$22.25. Share price fell 3.2% to US$8.17 over the past week. Is New 90 Day High Low • Mar 06
New 90-day low: US$11.25 The company is down 14% from its price of US$13.15 on 04 December 2020. The American market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 1.0% over the same period. Aankondiging • Feb 12
Fusion Pharmaceuticals Appoints Philina Lee to Its Board of Directors Fusion Pharmaceuticals Inc. announced the appointment of Philina Lee as a member of the Company's Board of Directors. Dr. Lee, who currently serves as senior vice president, head of portfolio strategy at Blueprint Medicines Corporation, brings to the board 15 years of experience in the biopharmaceutical industry. She previously was head of U.S. marketing for Algeta, developer of the first marketed alpha-emitting radiopharmaceutical. Dr. Lee joined Blueprint Medicines in 2014 and has served in positions of increasing responsibility, including leading new product strategy, establishing the commercial organization, building infrastructure to enable patient access, and leading multiple new product launches. In her current role she is responsible for providing strategic and operational leadership across the portfolio, leading the portfolio management team as well as the program leadership and program management functions. Prior to joining Blueprint Medicines, Dr. Lee served as head of U.S. marketing at Algeta ASA, where she was the second hire in the U.S. Is New 90 Day High Low • Jan 27
New 90-day low: US$11.26 The company is down 8.0% from its price of US$12.23 on 29 October 2020. The American market is up 21% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 28% over the same period. Is New 90 Day High Low • Jan 12
New 90-day low: US$11.56 The company is down 9.0% from its price of US$12.69 on 13 October 2020. The American market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 14% over the same period. Aankondiging • Dec 18
TRIUMF Enters Collaboration with Fusion Pharmaceuticals to Boost Production of Actinium-225, A Cancer-Fighting Medical Isotope TRIUMF announced it has entered into a collaboration agreement with Fusion Pharmaceuticals Inc. Under the agreement, Fusion will provide a financial investment enabling TRIUMF to upgrade its actinium-225 production infrastructure, and in return will receive preferred access to actinium-225, a rare medical isotope that shows great promise in new, cutting-edge cancer therapies.
An alpha-emitting isotope with a short half-life, actinium-225 can be combined with a molecular agent that specifically targets cancer cells, seeking out and destroying the cancer while leaving the surrounding tissue unharmed. The new collaboration will enable TRIUMF to significantly increase its production and delivery of actinium-225. Aankondiging • Dec 11
Fusion Pharmaceuticals Inc. Initiates Multi-Dose Portion of Phase 1 Trial of FPI-1434 in Patients with Advanced Solid Tumors Fusion Pharmaceuticals Inc. announced that the first patient has been dosed in the multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion's proprietary Fast-Clear linker to connect a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), with the alpha-emitting isotope actinium-225, creating a targeted alpha therapy (TAT). 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. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. As part of the precision medicine approach, prior to receiving the therapeutic injection of FPI-1434, patients are administered an indium-111 imaging analogue, [111In]-FPI-1547 (FPI-1547). The images collected are used to confirm the presence of tumor uptake and to ensure that estimated radiation doses to organs and tissues are below protocol-specified safety limits. The multi-dose study follows completion of the single-dose portion of the Phase 1 study, which showed that FPI-1434 was generally well tolerated with no dose limiting toxicities or treatment-related serious adverse events reported to date. The multi-dose portion of the study is expected to enroll patients at sites in Canada, the United States and Australia. The initial patient cohort is being dosed with FPI-1434 at 75kBq/kg with repeat cycles every six weeks up to allowable limits. Is New 90 Day High Low • Nov 05
New 90-day high: US$13.73 The company is up 3.0% from its price of US$13.35 on 07 August 2020. The American market is up 4.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Aankondiging • Sep 30
Fusion Pharmaceuticals Appoints Maria Stahl as Chief Legal Officer Fusion Pharmaceuticals Inc. announced the appointment of Maria Stahl as chief legal officer. Prior to joining Fusion, Ms. Stahl held executive leadership roles at Tetraphase Pharmaceuticals, including chief business officer and general counsel. Before joining Tetraphase, Ms. Stahl was the senior vice president, general counsel of Idenix Pharmaceuticals. Ms. Stahl began her career with the law firm Wilmer Cutler Pickering Hale and Dorr LLP. Is New 90 Day High Low • Sep 26
New 90-day low: US$12.20 The company is down 28% from its price of US$17.00 on 26 June 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.