0000950170-24-044122.txt : 20240412 0000950170-24-044122.hdr.sgml : 20240412 20240412170234 ACCESSION NUMBER: 0000950170-24-044122 CONFORMED SUBMISSION TYPE: 8-K/A PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20240409 ITEM INFORMATION: Other Events FILED AS OF DATE: 20240412 DATE AS OF CHANGE: 20240412 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Fusion Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001805890 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: Z4 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K/A SEC ACT: 1934 Act SEC FILE NUMBER: 001-39344 FILM NUMBER: 24842225 BUSINESS ADDRESS: STREET 1: 270 LONGWOOD ROAD SOUTH CITY: HAMILTON STATE: A6 ZIP: L8P 0A6 BUSINESS PHONE: 289-799-0891 MAIL ADDRESS: STREET 1: 270 LONGWOOD ROAD SOUTH CITY: HAMILTON STATE: A6 ZIP: L8P 0A6 8-K/A 1 fusn-20240409.htm 8-K/A 8-K/A
0001805890true00-000000000018058902024-04-092024-04-09

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K/A

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 9, 2024

 

 

Fusion Pharmaceuticals Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Canada

001-39344

Not applicable

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

270 Longwood Rd., S.

 

Hamilton, Ontario, Canada

 

L8P 0A6

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (289) 799-0891

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common shares, no par value per share

 

FUSN

 

The NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 8.01 Other Events.

On April 9, 2024, Fusion Pharmaceuticals Inc. (the “Company”) presented a poster at the American Association for Cancer Research Annual Meeting 2024 (the “Original AACR Poster”), which showed interim efficacy and safety data from the Phase 2 TATCIST open-label clinical trial evaluating FPI-2265, an actinium-225 based PSMA-I&T targeting radioconjugate (“RC”) for the treatment of metastatic castration-resistant prostate cancer. The Original AACR Poster noted that a ≥50% decline in prostate-specific antigen by 12 weeks after first treatment (“PSA50”) was achieved in 61% of lutetium-naïve participants and 42% of lutetium-treated participants. PSA50 was actually achieved in 54% of lutetium-naïve participants and 43% of lutetium-treated participants. All other data contained in the Original AACR Poster remains unchanged.

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Fusion Pharmaceuticals Inc.

Date: April 12, 2024

By:

/s/ Maria Stahl

Maria Stahl

Chief Legal Officer

 

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Amendment Description On April 9, 2024, Fusion Pharmaceuticals Inc. (the “Company”) presented a poster at the American Association for Cancer Research Annual Meeting 2024 (the “Original AACR Poster”), which showed interim efficacy and safety data from the Phase 2 TATCIST open-label clinical trial evaluating FPI-2265, an actinium-225 based PSMA-I&T targeting radioconjugate (“RC”) for the treatment of metastatic castration-resistant prostate cancer. The Original AACR Poster noted that a ≥50% decline in prostate-specific antigen by 12 weeks after first treatment (“PSA50”) was achieved in 61% of lutetium-naïve participants and 42% of lutetium-treated participants. PSA50 was actually achieved in 54% of lutetium-naïve participants and 43% of lutetium-treated participants. All other data contained in the Original AACR Poster remains unchanged.
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(the “Company”) presented a poster at the American Association for Cancer Research Annual Meeting 2024 (the “Original AACR Poster”), which showed interim efficacy and safety data from the Phase 2 TATCIST open-label clinical trial evaluating FPI-2265, an actinium-225 based PSMA-I&T targeting radioconjugate (“RC”) for the treatment of metastatic castration-resistant prostate cancer. The Original AACR Poster noted that a ≥50% decline in prostate-specific antigen by 12 weeks after first treatment (“PSA50”) was achieved in 61% of lutetium-naïve participants and 42% of lutetium-treated participants. PSA50 was actually achieved in 54% of lutetium-naïve participants and 43% of lutetium-treated participants. All other data contained in the Original AACR Poster remains unchanged.