FUSN Fusion Pharmaceuticals Inc.

8.86
+0.16  (+2%)
Previous Close 8.7
Open 8.57
52 Week Low 8.09
52 Week High 19
Market Cap $376,064,304
Shares 42,445,181
Float 41,859,134
Enterprise Value $150,694,140
Volume 11,164
Av. Daily Volume 39,880
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  1. HAMILTON, ON and BOSTON, May 6, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion's lead candidate, [225Ac]-FPI-1434 (FPI-1434), in combination with Merck's anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R).

    "With our strong preclinical data demonstrating promising activity with FPI-1434 and immuno-oncology agents, we believe we have an opportunity to improve efficacy in tumor indications where KEYTRUDA is approved, and to potentially expand into new tumor indications," said Chief Executive Officer John Valliant, Ph.D. "This collaboration with Merck builds off our research on the mechanism of action of alpha radiation and aligns with our goal to expand the utility of radiopharmaceutical therapies, including advancing into earlier lines of cancer therapy."

    The planned Phase 1/2 combination trial will evaluate safety, tolerability and pharmacokinetics of FPI-1434 in combination with pembrolizumab and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    About FPI-1434

    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.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the process of designing and conducting clinical trials, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the timing and outcome of our clinical trials and the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's annual report on Form 10-K for the year ended December 31, 2020 which is available on the Security and Exchange Commission's website at www.sec.gov and Fusion's website at www.fusionpharma.com.

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    SOURCE Fusion Pharmaceuticals Inc.

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  2. HAMILTON, ON and BOSTON, April 14, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will present at the Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 20, 2021 at 10:30am EDT. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. A replay of the webcast will be archived on the Company's website for 90 days following the presentation.  

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

     

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  3. Product candidate FPI-1434, when administered with olaparib, resulted in enhanced efficacy against colorectal and lung cancer xenografts

    Combination of IGF-1R targeted alpha therapy with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models

    Data featured in e-poster sessions at the 2021 AACR Virtual Annual Meeting

    HAMILTON, ON and BOSTON, April 10, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data at the 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting. The posters will be presented during the Preclinical…

    Product candidate FPI-1434, when administered with olaparib, resulted in enhanced efficacy against colorectal and lung cancer xenografts

    Combination of IGF-1R targeted alpha therapy with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models

    Data featured in e-poster sessions at the 2021 AACR Virtual Annual Meeting

    HAMILTON, ON and BOSTON, April 10, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data at the 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting. The posters will be presented during the Preclinical Radiotherapeutics and Combination Immunotherapies sessions taking place today. The posters highlight the potential of Fusion's targeted alpha therapies (TATs) to enable delivery of an alpha particle emitting isotope (actinium-225) as both monotherapies and combination therapies across multiple tumor types.  

    "These data are the result of Fusion's early investments in research to understand the power of combining our potent TATs with the latest generation of cancer therapies, such as checkpoint inhibitors and DNA damage response inhibitors (DDRis), and they reinforce our belief in the potential of our pipeline of TATs to redefine the utility of radiopharmaceuticals in the cancer treatment paradigm," said Fusion Chief Executive Officer John Valliant, Ph.D. "We believe we have an opportunity to advance clinical development of our product candidate FPI-1434 as monotherapy and in combination with these novel agents, leading to more treatment options for patients in earlier lines of therapy."

    In one set of preclinical studies, highlighted in poster number LB130 titled, "Combination of IGF-1R Targeted Alpha Therapy with Olaparib Results in Synergistic Efficacy Against Colorectal and Lung Cancer Xenografts," results demonstrated that the delivery of alpha-particle radiation by FPI-1434 induced double-stranded DNA breaks and apoptosis in treated colorectal cancer tumor xenografts. Co-dosing with the PARP (poly ADP-ribose polymerase) inhibitor olaparib resulted in lower doses required for efficacy of FPI-1434 in lung and colorectal cancer tumor xenografts, supporting the potential clinical development of this combination.

    In an additional set of preclinical studies, highlighted in poster number LB155 titled, "Combination of IGF-1R Targeted Alpha Therapy with Checkpoint Inhibitors Results in Synergistic Efficacy in Colorectal Cancer Syngeneic Model," data showed that treatment with IGF-1R TAT 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.

    About FPI-1434

    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.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    Forward Looking Statements

    This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.'s (the "Company") future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential drug candidates, including any expressed or implied statements regarding the successful development of product candidate FPI-1434; and the likelihood of success of any ongoing or future clinical trials involving product candidate FPI-1434. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-K for the quarter ended December 31, 2020 as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

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    SOURCE Fusion Pharmaceuticals Inc.

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  4. HAMILTON, ON and BOSTON, April 1, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it has completed the acquisition of Ipsen's (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. 

    Under the terms of the agreement, Fusion issued to Ipsen 600,000 shares of its common stock at the time of closing, including shares due upon the achievement of a patent-related milestone which occurred prior to closing. Such shares were issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the asset purchase agreement. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

    The closing of the acquisition was subject to the satisfaction of customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Additional details regarding the financial terms can be found in Fusion's Form 8-K filed with the Securities and Exchange Commission on March 2, 2021.

    About FPI-2059

    FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

    About Ipsen

    Ipsen is a global mid-size biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2020, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US; Shanghai, China). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (OTC:IPSEY). For more information on Ipsen, visit www.ipsen.com.fr

    Forward Looking Statements

    This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.'s (the "Company") future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential drug candidates, including any expressed or implied statements regarding the successful development of FPI-2059; the likelihood and success of any future clinical trials involving FPI-2059 or any novel Targeted Alpha Therapies; and the expected benefits of the acquisition of IPN-1087. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the quarter ended December 31, 2020 as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

     

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    SOURCE Fusion Pharmaceuticals Inc.

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  5. HAMILTON, ON and BOSTON, April 1, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines today announced the appointment of Donald A. Bergstrom, M.D., Ph.D., as a member of the Company's Board of Directors. Dr. Bergstrom, who currently serves as executive vice president, head of research and development at Relay Therapeutics, Inc., a clinical stage precision medicines company, brings to the board more than 15 years of experience in the biopharmaceutical industry.

    "Don's depth of precision oncology and industry experience will be invaluable to us as we continue to progress our Targeted Alpha Therapies (TAT) platform and grow our pipeline of clinical candidates," said Fusion Chief Executive Officer John Valliant, Ph.D. "Additionally, his leadership and understanding of the oncology landscape will provide Fusion with important organizational, strategic and operational guidance during this growth period." 

    Prior to joining Relay Therapeutics in 2018, Dr. Bergstrom served as senior vice president, chief medical officer of Mersana Therapeutics, Inc., a clinical-stage biopharmaceutical company discovering and developing novel antibody-drug-conjugates for the treatment of cancer. Prior to Mersana, Dr. Bergstrom was global head of translational and experimental medicine at Sanofi Oncology and held roles of increasing responsibility in oncology translational medicine and early clinical development at Merck Research Laboratories.

    Dr. Bergstrom holds an M.D. and a Ph.D. from the University of Washington, Seattle and a B.A. from the Johns Hopkins University.

    "I see significant potential to use the Targeted Alpha Therapies (TAT) platform to build a strong portfolio of precision medicines," said Dr. Bergstrom. "I'm excited to join the board, as I share the Fusion team's passion for improving the lives of cancer patients and I look forward to contributing to Fusion's strategic planning and growth."

    The number of seats on the Fusion Board of Directors was increased to nine from eight immediately prior to Dr. Bergstrom's election.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

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