Fusion Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Announces Clinical Program Updates
Company recently announced definitive agreement to be acquired by AstraZeneca
FPI-2265 Phase 2/3 registrational program for patients with metastatic castration-resistant prostate cancer (mCRPC) expected to begin in Q2 2024
Interim data from TATCIST study of FPI-2265 to be presented at the 2024
Fusion is now producing and shipping clinical doses of FPI-2265 from its state-of-the-art GMP manufacturing facility
Chief Executive Officer
Corporate Update
On
The upfront cash portion of the consideration represents a transaction value of approximately
The transaction is expected to close in the second quarter of 2024, subject to customary closing conditions, including the approval of Fusion shareholders and regulatory clearances.
Portfolio Update
FPI-2265: A 225Ac based radiopharmaceutical targeting prostate specific membrane antigen (PSMA) for the treatment of patients with mCRPC.
- In
January 2024 , the Company announced alignment with the FDA on its Phase 2/3 protocol for FPI-2265 in patients with mCRPC with progressive disease who have previously been treated with a 177Lu-based PSMA radiotherapy. The development plan includes a Phase 2 dose optimization lead-in, which aims to evaluate whether there are added safety and/or efficacy benefits of various dosing regimens in comparison to the validated regimen of 100kBq/kg every eight weeks, expected to be initiated in the second quarter of 2024. This Phase 2 portion 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 FDA, a Phase 3 global registrational trial in approximately 550 patients is expected to begin in 2025. - The TATCIST trial, which began as an investigator sponsored study, is designed to evaluate FPI-2265 in patients with mCRPC with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceutical therapy, completed target enrollment of 25-30 patients. The Company announced that interim data will be presented at the upcoming 2024
American Association for Cancer Research (AACR) Annual Meeting in April. - The Company is also pursuing the opportunity to potentially move this therapeutic candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the first half of this year.
FPI-1434: Targeting insulin growth factor 1 receptor (IGF1R).
- In
January 2024 , Fusion announced encouraging early findings from Cohort 2 in the cold/hot dosing arm of the ongoing Phase 1, multi-center, open-label clinical trial. The 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. No dose limiting toxicities (DLTs) were observed to date in the 25 kBq/kg dose cohort. Two out of three patients completed the DLT period, and one pancreatic cancer patient discontinued treatment due to disease progression. Evidence of anti-tumor activity was observed in a heavily pre-treated patient with Ewing sarcoma after a single dose and a second patient receiving four cycles of therapy demonstrated stable disease as best response. - The Company plans to complete and further evaluate results from Cohort 2 and hold a Safety Review Committee (SRC) meeting to evaluate the emerging data. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024.
FPI-2059: Targeting neurotensin receptor 1 (NTSR1).
- Patient enrollment and dosing is ongoing in the Phase 1, multi-center, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors. Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment.
FPI-2068: A bispecific IgG-based targeted alpha therapy (TAT) targeting EGFR-cMET.
- FPI-2068 is currently being evaluated in a Phase 1 study and is being jointly developed with AstraZeneca under the companies' multi-asset collaboration agreement. FPI-2068 is a bispecific IgG-based TAT designed to deliver actinium-225 to various solid tumors that express 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. The investigational new drug (IND) application has been cleared and Fusion is currently activating clinical trial sites.
Other Recent Updates
- In
January 2024 , Fusion announced it had completed validation of its state-of-the-art GMP manufacturing facility and produced the first clinical dose of a TAT. The facility, which has clinical and commercial scale manufacturing capacity, is designed to support the Company's growing pipeline of TATs and is expected to be capable of producing more than 100,000 doses per year. - In
February 2024 , Fusion announced that it has entered into a licensing agreement withHeidelberg University and Euratom represented by theEuropean Commission ,Joint Research Centre (together, the "Licensors"). The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture and commercialize compounds covered by the patent, which includes 225Ac-PSMA I&T ("FPI-2265") for the treatment of prostate specific membrane antigen (PSMA)-expressing cancers. In addition, Fusion and the Licensors have signed an agreement to settle the parties' dispute related to an inter partes review ("IPR") of the patent which was instituted inAugust 2023 by the United States Patent and Trademark Board.
Fourth Quarter 2023 Financial Results
- Cash and Investments: As of
December 31, 2023 , Fusion held cash, cash equivalents and investments of$247.3 million , compared to cash, cash equivalents and investments of$186.6 million as ofDecember 31, 2022 . Fusion expects its existing cash, cash equivalents and investments as ofDecember 31, 2023 , together with net proceeds from sales of common shares under the Company's at-the-market equity offering program received in January andFebruary 2024 and net proceeds of$14.9 million from a draw down under the Company's existing debt facility inJanuary 2024 , will be sufficient to fund operations into the fourth quarter of 2025. - R&D Expenses: Research and development expenses for the fourth quarter of 2023 were
$20.6 million , compared to$17.6 million for the same period in 2022. The increase was primarily due to increased manufacturing-related expenditures, as well as increased personnel-related costs. - G&A Expenses: General and administrative expenses for the fourth quarter of 2023 were
$7.6 million , compared to$6.9 million for the same period in 2022. The increase was primarily due to increased consulting and personnel-related costs. - Net Loss: For the fourth quarter of 2023, Fusion reported a net loss of
$28.2 million , or$0.39 per share, compared with a net loss of$24.6 million , or$0.55 per share, for the same period in 2022.
Upcoming Presentations
Fusion will present data in a poster presentation at the
- Title: Preliminary efficacy and safety results from the (TACIST) trial: A PSMA-directed targeted alpha therapy with FPI-2265 (225Ac-PSMA-I&T) for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
- Session: Phase II Clinical Trials 1
-
Date and Time:
Tuesday April 9, 2024 9:00 AM - 12:30 PM PT - Location: Poster Section 49
- Abstract Number: CT224
About Fusion
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 the future business and financial performance of
Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, www.fusionpharma.com, including, but not limited to, company disclosures, investor presentations,
Contact:
Senior Director of Investor Relations & Corporate Communications
(617) 967-0207
cray@fusionpharma.com
CONDENSED CONSOLIDATED BALANCE SHEET DATA (In thousands) (Unaudited) |
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|
|
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|
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2023 |
|
|
2022 |
|
||
Cash, cash equivalents and investments |
|
$ |
247,344 |
|
|
$ |
186,635 |
|
Total assets |
|
|
285,836 |
|
|
|
219,064 |
|
Total liabilities |
|
|
63,356 |
|
|
|
56,843 |
|
Total stockholders' equity |
|
|
222,480 |
|
|
|
162,221 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) |
||||||||||||||||
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Three Months Ended |
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Year Ended |
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2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Collaboration revenue |
|
$ |
— |
|
|
$ |
140 |
|
|
$ |
2,068 |
|
|
$ |
1,461 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
20,647 |
|
|
|
17,607 |
|
|
|
70,103 |
|
|
|
58,895 |
|
General and administrative |
|
|
7,628 |
|
|
|
6,950 |
|
|
|
31,197 |
|
|
|
30,600 |
|
Total operating expenses |
|
|
28,275 |
|
|
|
24,557 |
|
|
|
101,300 |
|
|
|
89,495 |
|
Loss from operations |
|
|
(28,275) |
|
|
|
(24,417) |
|
|
|
(99,232) |
|
|
|
(88,034) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
2,292 |
|
|
|
1,308 |
|
|
|
9,526 |
|
|
|
2,161 |
|
Interest expense |
|
|
(1,336) |
|
|
|
(1,168) |
|
|
|
(5,166) |
|
|
|
(1,801) |
|
Other income (expense), net |
|
|
436 |
|
|
|
(680) |
|
|
|
762 |
|
|
|
(1,775) |
|
Total other income (expense), net |
|
|
1,392 |
|
|
|
(540) |
|
|
|
5,122 |
|
|
|
(1,415) |
|
Loss before (provision) benefit for income taxes |
|
|
(26,883) |
|
|
|
(24,957) |
|
|
|
(94,110) |
|
|
|
(89,449) |
|
Income tax (provision) benefit |
|
|
(1,296) |
|
|
|
340 |
|
|
|
(787) |
|
|
|
1,837 |
|
Net loss |
|
$ |
(28,179) |
|
|
$ |
(24,617) |
|
|
$ |
(94,897) |
|
|
$ |
(87,612) |
|
Unrealized gain (loss) on investments |
|
|
1,078 |
|
|
|
787 |
|
|
|
706 |
|
|
|
(354) |
|
Comprehensive loss |
|
$ |
(27,101) |
|
|
$ |
(23,830) |
|
|
$ |
(94,191) |
|
|
$ |
(87,966) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share—basic and diluted |
|
$ |
(0.39) |
|
|
$ |
(0.55) |
|
|
$ |
(1.45) |
|
|
$ |
(2.00) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average common shares outstanding—basic and diluted |
|
|
73,094,249 |
|
|
|
44,766,314 |
|
|
|
65,611,923 |
|
|
|
43,748,549 |
|
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