A Phase 2/3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I&T) in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT).

Start Date05 Mar 2024

Sponsor / Collaborator

Fusion Pharmaceuticals, Inc.

NCT05219500 / RecruitingPhase 2

PSMA-directed Targeted Alpha Therapy With FPI-2265 (225Ac-PSMA-I&T) for the Treatment of Metastatic Castration-resISTant Prostate Cancer (TATCIST). A Phase II Clinical Trial.

The treatment regimen will consist of 4 doses of FPI-2265

Start Date16 Dec 2021

Sponsor / Collaborator

Fusion Pharmaceuticals, Inc.

100 Clinical Results associated with FPI-2265

100 Translational Medicine associated with FPI-2265

100 Patents (Medical) associated with FPI-2265

Literatures (Medical) associated with FPI-2265

01 Apr 2021·European journal of nuclear medicine and molecular imagingQ1 · MEDICINE

Response to 225Ac-PSMA-I&T after failure of long-term 177Lu-PSMA RLT in mCRPC

Q1 · MEDICINE

Article

Author: Bartenstein, Peter ; Ilhan, Harun ; Zacherl, Mathias ; Völter, Friederike ; Gosewisch, Astrid ; Todica, Andrei ; Gildehaus, Franz Josef ; Böning, Guido ; Unterrainer, Marcus

Czerwinska M, Bilewicz A, Kruszewski M, Wegierek-Ciuk A, Lankoff A. Targeted radionuclide therapy of prostate cancer-from basic research to clinical perspectives. Molecules. 2020;25. https://doi-org.libproxy1.nus.edu.sg/10.3390/molecules25071743. Khreish F, Ebert N, Ries M, Maus S, Rosar F, Bohnenberger H, et al. (225)Ac-PSMA-617/(177)Lu-PSMA-617 tandem therapy of metastatic castration-resistant prostate cancer: pilot experience. Eur J Nucl Med Mol Imaging. 2020;47:721–8. https://doi-org.libproxy1.nus.edu.sg/10.1007/s00259-019-04612-0. CAS Article Google Scholar Sathekge M, Bruchertseifer F, Vorster M, Lawal IO, Knoesen O, Mahapane J, et al. Predictors of overall and disease-free survival in metastatic castration-resistant prostate cancer patients receiving (225)Ac-PSMA-617 radioligand therapy. J Nucl Med. 2020;61:62–9. https://doi-org.libproxy1.nus.edu.sg/10.2967/jnumed.119.229229. CAS Article Google Scholar Sathekge M, Bruchertseifer F, Knoesen O, Reyneke F, Lawal I, Lengana T, et al. (225)Ac-PSMA-617 in chemotherapy-naive patients with advanced prostate cancer: a pilot study. Eur J Nucl Med Mol Imaging. 2019;46:129–38. https://doi-org.libproxy1.nus.edu.sg/10.1007/s00259-018-4167-0. CAS Article PubMed Google Scholar Download references Open Access funding enabled and organized by Projekt DEAL. Department of Nuclear Medicine, University Hospital, LMU Munich, Munich, Germany Harun Ilhan, Astrid Gosewisch, Guido Boning, Friederike Volter, Mathias Zacherl, Peter Bartenstein, Andrei Todica & Franz Josef Gildehaus Department of Radiology, University Hospital, LMU Munich, Munich, Germany Marcus Unterrainer You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar Correspondence to Harun Ilhan. All procedures performed in this study involving human participants were in accordance with ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This retrospective evaluation was approved by the local ethic committee (20-178). Written informed consent was obtained prior to the exam. The authors declare that they have no conflict of interest. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This article is part of the Topical Collection on Image of the month. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Reprints and Permissions Ilhan, H., Gosewisch, A., Boning, G. et al. Response to 225Ac-PSMA-I&T after failure of long-term 177Lu-PSMA RLT in mCRPC. Eur J Nucl Med Mol Imaging (2020). https://doi-org.libproxy1.nus.edu.sg/10.1007/s00259-020-05023-2 Download citation Received: 13 June 2020 Accepted: 31 August 2020 Published: 22 September 2020 DOI: https://doi-org.libproxy1.nus.edu.sg/10.1007/s00259-020-05023-2

01 Apr 2021·European journal of nuclear medicine and molecular imagingQ1 · MEDICINE

Image-based dosimetry for 225Ac-PSMA-I&T therapy using quantitative SPECT

Q1 · MEDICINE

Article

Author: Böning, G ; Gildehaus, F J ; Ilhan, H ; Kaiser, L ; Gosewisch, A ; Schleske, M ; Berg, I ; Brosch, J ; Bartenstein, P ; Todica, A

Kratochwil C, et al. Targeted alpha therapy of mCRPC with 225actinium-PSMA-617: dosimetry estimate and empirical dose finding. J Nucl Med. 2017;8(10):1624–31 p. jnumed. 117.191395. Article Google Scholar Robertson A, et al. Multi-isotope SPECT imaging of the 225Ac decay chain: feasibility studies. Phys Med Biol. 2017;62(11):4406. CAS Article Google Scholar Usmani S, et al. 225Ac prostate-specific membrane antigen posttherapy α imaging: comparing 2 and 3 photopeaks. Clin Nucl Med. 2019;44(5):401–3. Article Google Scholar Vatsa R, et al. 225Ac-PSMA-617 radioligand posttherapy imaging in metastatic castrate-resistant prostate cancer patient using 3 Photopeaks. Clin Nucl Med. 2020;45(6):437–8. Article Google Scholar Chun SY, Fessler JA, Dewaraja YK. Correction for collimator-detector response in SPECT using point spread function template. IEEE Trans Med Imaging. 2012;32(2):295–305. Article Google Scholar Delker A, et al. Dosimetry for 177 Lu-DKFZ-PSMA-617: a new radiopharmaceutical for the treatment of metastatic prostate cancer. Eur J Nucl Med Mol Imaging. 2016;43(1):42–51. CAS Article Google Scholar Gosewisch A, et al. Patient-specific image-based bone marrow dosimetry in Lu-177-[DOTA 0, Tyr 3]-Octreotate and Lu-177-DKFZ-PSMA-617 therapy: investigation of a new hybrid image approach. EJNMMI Res. 2018;8(1):76. Article Google Scholar Download references Open Access funding enabled and organized by Projekt DEAL. Department of Nuclear Medicine, University Hospital, LMU Munich, Munich, Germany A. Gosewisch, M. Schleske, F. J. Gildehaus, I. Berg, L. Kaiser, J. Brosch, P. Bartenstein, A. Todica, H. Ilhan & G. Boning You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar Correspondence to H. Ilhan. All procedures performed in this study involving human participants were in accordance with ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The retrospective evaluation was approved by the local ethic committee (20-178). Written informed consent was obtained prior to the exam. The authors declare that they have no conflict of interest. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This article is part of the Topical Collection on Image of the month. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Reprints and Permissions Gosewisch, A., Schleske, M., Gildehaus, F.J. et al. Image-based dosimetry for 225Ac-PSMA-I&T therapy using quantitative SPECT. Eur J Nucl Med Mol Imaging (2020). https://doi-org.libproxy1.nus.edu.sg/10.1007/s00259-020-05024-1 Download citation Received: 13 June 2020 Accepted: 31 August 2020 Published: 21 September 2020 DOI: https://doi-org.libproxy1.nus.edu.sg/10.1007/s00259-020-05024-1

Biomedicines

Total Tumor Volume on 18F-PSMA-1007 PET as Additional Imaging Biomarker in mCRPC Patients Undergoing PSMA-Targeted Alpha Therapy with 225Ac-PSMA-I&T

Article

Author: Unterrainer, Marcus ; Bartenstein, Peter ; Todica, Andrei ; Kunte, Sophie C ; Unterrainer, Lena M ; Schmidt-Hegemann, Nina-Sophie ; Casuscelli, Jozefina ; Albert, Nathalie L ; Wenter, Vera ; Stief, Christian G ; Kunz, Wolfgang G ; Brendel, Matthias ; Sheikh, Gabriel T ; Herlemann, Annika ; Zacherl, Mathias J ; Gildehaus, Franz J ; Beyer, Leonie ; Ilhan, Harun ; Ricke, Jens ; Holzgreve, Adrien ; Cyran, Clemens C

Background: PSMA-based alpha therapy using 225Ac-PSMA-I&T provides treatment for metastatic castration-resistant prostate cancer (mCRPC), even after the failure of 177Lu-PSMA radioligand therapy (RLT). In clinical routine, the total tumor volume (TTV) on PSMA PET impacts therapy outcomes and plays an increasing role in mCRPC patients. Hence, we aimed to assess TTV and its changes during 225Ac-PSMA-I&T RLT. Methods: mCRPC patients undergoing RLT with 225Ac-PSMA-I&T with available 18F-PSMA-1007 PET/CT prior to therapy initiation were included. TTV was assessed in all patients using established cut-off values. Image derived, clinical and biochemistry parameters (PSA, LDH, AP, pain score) were analyzed prior to and after two cycles of 225Ac-PSMA. Changes in TTV and further parameters were directly compared and then correlated with established response criteria, such as RECIST 1.1 or mPERCIST. Results: 13 mCRPC patients were included. The median overall survival (OS) was 10 months. Prior to 225Ac-PSMA RLT, there was no significant correlation between TTV with other clinical parameters (p > 0.05 each). Between short-term survivors (STS, <10 months OS) and long-term survivors (LTS, ≥10 months OS), TTV and PSA were comparable (p = 0.592 & p = 0.286, respectively), whereas AP was significantly lower in the LTS (p = 0.029). A total of 7/13 patients completed two cycles and underwent a follow-up 18F-PSMA-1007 PET/CT. Among these patients, there was a significant decrease in TTV (median 835 vs. 201 mL, p = 0.028) and PSA (median 687 ng/dL vs. 178 ng/dL, p = 0.018) after two cycles of 225Ac-PSMA RLT. Here, percentage changes of TTV after two cycles showed no direct correlation to all other clinical parameters (p > 0.05 each). In two patients, new PET-avid lesions were detected on 18F-PSMA-1007 PET/CT. However, TTV and PSA were decreasing or stable. Conclusion: PET-derived assessment of TTV is an easily applicable imaging biomarker independent of other established parameters prior to 225Ac-PSMA RLT in these preliminary follow-up data. Even after the failure of 177Lu-PSMA, patients with extensive TTV seem to profit from RLT. All but one patient who was eligible for ≥2 cycles of 225Ac-PSMA-RLT demonstrated drastic TTV decreases without direct correlation to other biomarkers, such as serum PSA changes. Changes in TTV might hence improve the response assessment compared to standard classifiers by reflecting the current tumor load independent of the occurrence of new lesions.

News (Medical) associated with FPI-2265

04 Jun 2024

·www.prnewswire.com

Acquisition of Fusion Pharmaceuticals Completed

HAMILTON, ON and BOSTON, June 4, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs), announced the successful completion of the acquisition of all of the issued and outstanding shares of Fusion by a wholly-owned subsidiary of AstraZeneca AB by way of a statutory plan of arrangement under section 192 of the Canada Business Corporations Act, referred to as the Arrangement. The Arrangement marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. The Arrangement complements AstraZeneca's leading oncology portfolio with the addition of the Fusion pipeline of RCs, including their most advanced program, FPI-2265, a potential new treatment for patients with metastatic castration-resistant prostate cancer (mCRPC), and brings new expertise and pioneering R&D, manufacturing and supply chain capabilities in actinium-based RCs to AstraZeneca. The Arrangement is also expected to strengthen AstraZeneca's presence in and commitment to Canada. As a result of the Arrangement, Fusion has become a wholly owned subsidiary of AstraZeneca, with operations continuing in Canada and the US. Fusion shares will be delisted from the Nasdaq Stock Market and deregistered under the U.S. Securities Exchange Act of 1934. Fusion has submitted an application to cease to be a reporting issuer under applicable Canadian securities laws and to otherwise terminate Fusion's Canadian public reporting requirements. Financial Considerations Under the terms of the definitive agreement, AstraZeneca, through a subsidiary, has acquired all of Fusion's outstanding shares pursuant to the 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 prior to August 31, 2029. Combined, the upfront payment and maximum potential contingent value payment, if achieved, represent a transaction value of approximately $2.4 billion. As part of the Arrangement, AstraZeneca acquired the cash, cash equivalents and short-term investments on Fusion's balance sheet, which totaled $211 million as of March 31, 2024. The upfront consideration has been provided to Equiniti Trust Company, LLC, as depositary under the Arrangement, and, along with the contingent value rights, will be delivered to former securityholders (as applicable) of Fusion as soon as practicable on or after the date hereof. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation RCs. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical-stage development portfolio includes lead program, FPI-2265, targeting PSMA for mCRPC and novel RCs targeting solid tumors. Fusion has a fully operational Good Manufacturing Practice compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of radioconjugates. Forward Looking Information To the extent any statements made in this communication contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under Canadian securities law (collectively, "forward-looking statements"). Certain statements in this communication may constitute forward-looking statements, which reflect the expectations of Fusion's management. The use of words such as "may," "will," "could," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. Fusion's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors including but not limited to risks related to the ability of Fusion to meet the regulatory milestone, the response of business partners and competitors to the completion of the Arrangement, and/or potential difficulties in employee retention as a result of the Arrangement; and the failure to realize the expected benefits of the Arrangement. Please also refer to the factors discussed under "Risk Factors" and "Special Note Regarding Forward-looking Information" in Fusion's Annual Report on Form 10-K for the year ended December 31, 2023, with the U.S. Securities Exchange Commission ("SEC"), each as updated by Fusion's continuous disclosure filings, and the factors discussed under "Risk Factors" in the Management Information Circular and Proxy Statement dated April 25, 2024, all of which are available at and at . Forward-looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not or the times at or by which such performance or results will be achieved. All forward-looking statements herein are qualified in their entirety by its cautionary statement and are made as of the date of this document. Fusion disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. Notes Radioconjugates in oncology RCs combine the precise targeting of antibodies, small molecules or peptides with potent medical radioisotopes to deliver radiation directly to cancer cells. By seeking out cancer cells, RCs provide a more precise mechanism of cancer cell killing compared with traditional radiation therapy, with the goal of improving efficacy while minimizing toxicity on healthy cells. RCs are administered via systemic delivery, which enables their use in tumour types not accessible to external beam radiation and the targeting of cancer cells that have spread from the main tumour to other sites in the body. About FPI-2265 FPI-2265 is an actinium-225 based PSMA-targeting RC for mCRPC, currently in a Phase II 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. For further information: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-967-0207, [email protected] SOURCE Fusion Pharmaceuticals

AcquisitionRadiation TherapyPhase 2

31 May 2024

·www.prnewswire.com

Fusion Pharmaceuticals Receives Final Court Order Approving Arrangement

HAMILTON, ON and BOSTON, May 31, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, today announced it has obtained a final order from the Ontario Superior Court of Justice (Commercial List) approving the previously announced statutory plan of arrangement under Section 192 of the Canada Business Corporations Act, pursuant to which a wholly-owned subsidiary of AstraZeneca will acquire all issued and outstanding shares of Fusion (the " Arrangement"). Fusion shareholders will receive US$21.00 per share in cash upfront on completion of the Arrangement plus a deferred payment on the achievement of a future regulatory milestone in the form of a contingent value right of US$3.00 per share. As previously announced, Fusion's shareholders approved the Arrangement at a special meeting of Fusion's shareholders on May 29, 2024. The Arrangement is subject to customary closing conditions. Subject to the satisfaction of such conditions, the transaction is expected to be completed in the second quarter of 2024. Following closing of the Arrangement, Fusion's common shares will be delisted from NASDAQ. Further details regarding the Arrangement are set out in the management information circular/proxy dated April 25, 2024 which is available at and . About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation RCs. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical-stage development portfolio includes lead program, FPI-2265, targeting PSMA for mCRPC and novel RCs targeting solid tumors. Fusion has a fully operational Good Manufacturing Practice compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of radioconjugates. Forward Looking Information To the extent any statements made in this communication contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under Canadian securities law (collectively, "forward-looking statements"). Certain statements in this communication may constitute forward-looking statements, which reflect the expectations of Fusion's management regarding the Arrangement. The use of words such as "may," "will," "could," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. More particularly and without limitation, this communication contains forward-looking statements and information regarding anticipated timing of closing and the satisfaction or waiver of conditions to closing. Fusion's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors including but not limited to risks related to the satisfaction or waiver of the conditions to closing the Arrangement in the anticipated timeframe or at all, including the possibility that the Arrangement does not close. Please also refer to the factors discussed under "Risk Factors" and "Special Note Regarding Forward-looking Information" in Fusion's Annual Report on Form 10-K for the year ended December 31, 2023, with the U.S. Securities Exchange Commission ("SEC"), each as updated by Fusion's continuous disclosure filings, and the factors discussed under "Risk Factors" in the proxy statement and management information circular dated April 25, 2024, all of which are available at and at . Forward-looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not or the times at or by which such performance or results will be achieved. All forward-looking statements herein are qualified in their entirety by its cautionary statement and are made as of the date of this document. Fusion disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. For further information: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-967-0207, [email protected] SOURCE Fusion Pharmaceuticals

29 May 2024

·www.prnewswire.com

Fusion Pharmaceuticals Shareholders Approve Acquisition by AstraZeneca

HAMILTON, ON and BOSTON, May 29, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, today announced that at a special meeting of its shareholders (the " Shareholders"), held virtually earlier today, the Shareholders voted in favour of the resolution to approve the previously announced plan of arrangement with a wholly-owned subsidiary of AstraZeneca under the Canada Business Corporations Act pursuant to which AstraZeneca will acquire all of the issued and outstanding shares of Fusion (the " Arrangement"). As of the close of business on April 16, 2024, the record date of the special meeting, there were approximately 84,965,608 shares issued and outstanding and entitled to vote. A total of 68,678,602 shares were voted at the special meeting representing approximately 80.83% of the issued and outstanding shares as of the record date. The Arrangement was approved, receiving the required affirmative vote of (i) 99.92% of the votes cast by the Shareholders, voting as a single class, present in person or represented by proxy and entitled to vote at the special meeting and (ii) 99.92% of the votes cast by the Shareholders, present in person or represented by proxy and entitled to vote at the special meeting, after excluding the votes of those Shareholders whose votes are required to be excluded under Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions. The formal report on voting results with respect to all matters voted upon at the meeting will be filed under Fusion's profile on SEDAR+ at . The arrangement is subject to court approval, as well as other customary closing conditions. Subject to the satisfaction of such conditions, the transaction is expected to be completed in the second quarter of 2024. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation RCs. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical-stage development portfolio includes lead program, FPI-2265, targeting PSMA for mCRPC and novel RCs targeting solid tumors. Fusion has a fully operational Good Manufacturing Practice compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of radioconjugates. Forward Looking Information To the extent any statements made in this communication contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under Canadian securities law (collectively, "forward-looking statements"). Certain statements in this communication may constitute forward-looking statements, which reflect the expectations of Fusion's management regarding the Arrangement. The use of words such as "may," "will," "could," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. More particularly and without limitation, this communication contains forward-looking statements and information regarding anticipated timing of closing and the satisfaction or waiver of conditions to closing. Fusion's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors including but not limited to risks related to the satisfaction or waiver of the conditions to closing the Arrangement (including the failure to obtain necessary court approval) in the anticipated timeframe or at all, including the possibility that the Arrangement does not close. Please also refer to the factors discussed under "Risk Factors" and "Special Note Regarding Forward-looking Information" in Fusion's Annual Report on Form 10-K for the year ended December 31, 2023, with the U.S. Securities Exchange Commission ("SEC"), each as updated by Fusion's continuous disclosure filings, and the factors discussed under "Risk Factors" in the proxy statement and management information circular dated April 25, 2024, all of which are available at and at . Forward-looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not or the times at or by which such performance or results will be achieved. All forward-looking statements herein are qualified in their entirety by its cautionary statement and are made as of the date of this document. Fusion disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. For further information: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-967-0207, [email protected] SOURCE Fusion Pharmaceuticals

Acquisition

100 Deals associated with FPI-2265

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 3	US	Fusion Pharmaceuticals, Inc.	05 Mar 2024
PSMA-Positive Castration-Resistant Prostatic Cancer	Phase 3	US	Fusion Pharmaceuticals, Inc.	05 Mar 2024
Castration-Resistant Prostatic Cancer	Phase 1	US	RadioMedix, Inc.	02 Aug 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05219500 (TATCIST, PRNewswire) Manual	Phase 2	Metastatic castration-resistant prostate cancer	25	FPI-2265	kabzycyejn(bvfjxoquej) = prljsjzaqd katioqgjho (fgrjrbfxfe ) View more	Positive	09 Apr 2024
NCT05219500 (TATCIST, AACR2024) Manual	Phase 2	Metastatic castration-resistant prostate cancer Prostate specific antigen	30	FPI-2265	eyyqnodljv(lbrinkgwyo) = dry mouth (18/21 [86%]), fatigue (10/21 [48%]) dry eye (6/21 [28%]), and anemia (6/21 [28%]). All were Grade 1-2 in severity, expect anemia Grade 3 which was observed in (5/21 [24%]). Other Grade 3 TRAEs included decreased platelet count (3/21 [14%]). No Grade 4 or 5 TRAEs were reported. Dry mouth was primarily Grade 1 (13/21 [62%]) with only 5 patients (24%) experiencing Grade 2 dry mouth; qqhjvubgtu (dwsxqvwvnx )	Positive	05 Apr 2024

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