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  • Merger to invest $5 million for guaranteed access to actinium-225 supply
  • Deal increases existing Fusion offering as company expands portfolio of actinium-based radiopharmaceuticals

HAMILTON, ON and BOSTON and LANSING, Mich., June 10, 2022 /PRNewswire/ — Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of radio- medical isotopes based on radium and uranium, today announced that the companies have entered into a collaboration and supply agreement for the development, production and supply of actinium-225. Under the terms of the agreement, Fusion will invest up to $5 million to Niowave to further develop their technology to increase current actinium-225 production capacity, and in return, Fusion will be guaranteed access to a predetermined percentage of Niowave’s capacity of the resulting actinium-225, as well as privileged access to any product oversupply. As part of the agreement, Fusion will also have the ability to invest in future production of actinium-225 at the scale of Fusion’s needs.

“As enthusiasm for the tumor-killing potential of alpha-emitting radiopharmaceuticals grows, we intend to remain at the forefront of actinium development and supply to support our growing portfolio of targeted alpha therapies,” said said the managing director of Fusion. John ValiantPh.D. “We continue to prioritize manufacturing and access to actinium as a critical component of Fusion’s platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we grow advancing several actinium-based radiopharmaceuticals into the clinic.

“The Niowave team has worked hard to bring our actinium-225 production to the millicuria level, which has allowed us to begin working with community partners in oncology,” said the CEO/Principal Investigator. by Niowave. Terry GrimmPh.D. “We have watched Fusion’s progress in the development of their targeted alpha therapy pipeline and are very excited to partner with them on this journey.”

Fusion develops actinium-based TATs taking advantage of the power and precision offered by alpha particles. The decay of actinium-225 emits four alpha emissions in relatively rapid succession, maximizing tumor cell DNA damage, with a half-life of 10 days that allows central manufacturing and product distribution to clinical sites in a ready-to-use form.

Fusion currently has actinium supply agreements with TRIUMF and the US Department of Energy (DOE).

About Fusion

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion links alpha particle-emitting isotopes to various targeting molecules to selectively deliver alpha-emitting payloads to tumors. Fusion’s lead program, FPI-1434 targeting the insulin-like growth factor receptor 1, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the insulin-like growth factor receptor 3 Fibroblast Growth Factor (FGFR3), moving to a Phase 1 study after Investigational New Drug (IND) approval; and FPI-2059, a small molecule targeting neurotensin 1 receptor (NTSR1). In addition to a robust proprietary pipeline, Fusion is collaborating with AstraZeneca to co-develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and DNA damage repair inhibitors (DDRis) d ‘AstraZeneca and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with IGF-1R-expressing solid tumors. Merger and Hamilton, Ont.-based McMaster University are currently constructing a Good Manufacturing Practices (GMP) radiopharmaceutical manufacturing facility designed to support the manufacturing of the company’s growing TAT pipeline.

About Niowave

Niowave manufactures radioisotopes to cure cancer and save lives. Niowave builds and operates superconducting electron linear accelerators and uses this expertise to produce various radioisotopes for nuclear medicine. Niowave is a partner in a cooperative agreement with the National Nuclear Security Administration to develop a national supply of molybdenum-99 and currently produces yttrium-90 for use in the treatment of cancer. Niowave is licensed by the NRC to manufacture radioisotopes from uranium and radium and has partnerships with several universities and national laboratories focused on the production and purification of radioisotopes for use in cancer treatment. Using radium targets and electron beams, Niowave is able to produce ultra-pure (>99.9%) and carrier-free actinium-225. Niowave’s R&D center is currently providing actinium-225 samples to partners. Production-scale operations are ramping up at a second FDA-compliant facility capable of serving the growing actinium-225 market.

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, statements regarding the future business of Fusion Pharmaceuticals Inc. (the “Company”) and financial performance. For this purpose, all statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “expect”, “plan”, “anticipate”, “intend”, “will” and similar expressions are also intended to identify forward-looking statements, as are statements express or implied regarding the Company’s potential access to actinium-225. Actual results may differ materially from those indicated by these forward-looking statements due to risks and uncertainties, including, but not limited to, the following: There can be no assurance that the Company or its partners will advance any actinium-225 related technology to development, regulatory process or commercialization; management’s expectations could be affected by unforeseen regulatory actions or delays; and uncertainties related to clinical trials, or the unsuccessful results thereof, delays in clinical trials and the medical isotopes used in them. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. These and other risks that may impact management’s expectations are further described under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the Period Ended. March 31, 2022, as filed with the SEC and in any subsequent periodic or current reports 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 taken to reflect the opinions, expectations or beliefs of the Company as of any date subsequent to the date of this press release. . Although Fusion may elect to update these forward-looking statements at some time in the future, it expressly disclaims any obligation to do so, even if the Company’s estimates change.

Fusion contact:
Amanda Cray
Senior Director of Investor Relations and Corporate Communications
617-967-0207
[email protected]

Contact Niowave:
Denise Boucke
Director, Human Resources and Administration
517-999-3475
[email protected]

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SOURCE Fusion Pharmaceuticals Inc.

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