Presented interim data from TATCIST trial of FPI-2265 in mCRPC at the 2024
Signed definitive agreement to be acquired by AstraZeneca for total transaction value of up to
Chief Executive Officer
Corporate Update
On
On
Portfolio Update
FPI-2265: A 225Ac-based RC targeting PSMA for the treatment of patients with mCRPC.
- In
April 2024 , Fusion presented interim data from the Phase 2 TATCIST trial evaluating FPI-2265 at the 2024 AACR Annual Meeting. Results demonstrated that FPI-2265 is active in heavily pretreated patients with progressive mCRPC, including patients who received prior lutetium-based radioligand therapy (RLT), and support Fusion's ongoing FPI-2265 Phase 2/3 development program. - 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. - Fusion is also pursuing the opportunity to potentially develop this product candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the second quarter of 2024.
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 its 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. - Fusion 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.
FPI-2068: A bispecific, IgG-based, EGFR-cMET targeted radioconjugate.
- FPI-2068 is currently being evaluated in a Phase 1 trial and is jointly developed with AstraZeneca. The investigational new drug application has been cleared and the trial is currently open and recruiting. 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.
First Quarter 2024 Financial Results
- Cash and Investments: As of
March 31, 2024 , Fusion held cash, cash equivalents and investments of$283.1 million , compared to cash, cash equivalents and investments of$247.3 million as ofDecember 31, 2023 . The increase was primarily attributed to proceeds from sales of common shares under the Company's at-the-market equity offering program received in the first quarter, as well as net proceeds from a draw down under the Company's existing debt facility. Fusion expects its existing cash, cash equivalents and investments as ofMarch 31, 2024 will be sufficient to fund operations into the fourth quarter of 2025. - Collaboration Revenue: For the first quarter of 2024, Fusion did not record any revenue under the AstraZeneca collaboration agreement. For the same period in 2023, Fusion recorded less than
$0.1 million of revenue under the AstraZeneca collaboration agreement. - R&D Expenses: Research and development expenses for the first quarter of 2024 were
$21.3 million , compared to$15.9 million for the same period in 2023. The increase was primarily due to an increase in FPI-2265 program-related costs for our Phase 2 clinical trial of FPI-2265 in patients with mCRPC, and an increase in manufacturing-related costs. - G&A Expenses: General and administrative expenses for the first quarter of 2024 were
$14.5 million , compared to$9.0 million for the same period in 2023. The increase was primarily due to an increase in professional fees due to higher legal and consulting expenses incurred in connection with the definitive agreement to be acquired by AstraZeneca. - Net Loss: For the first quarter of 2024, Fusion reported a net loss of
$33.7 million , or$0.40 per share, compared with a net loss of$24.3 million , or$0.45 per share, for the same period in 2023.
About Fusion
Cautionary Note Regarding Forward-Looking Statements
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
Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Fusion's actual results to materially differ 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 proposed transaction (including the failure to obtain necessary regulatory, court and Fusion's shareholder approvals) in the anticipated timeframe or at all, including the possibility that the proposed transaction does not close; the response of business partners and competitors to the announcement of the proposed transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction; significant transaction costs; the failure to realize the expected benefits of the proposed transaction; risks associated with the disruption of management's attention from ongoing business operations due to the proposed transaction; and unknown liabilities and the risk of litigation and/or regulatory actions related to the proposed transaction. These may also include, but are 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 in or to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected patient recruitment delays or 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; changes in the Company's business plan or objectives; and competition in general.
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
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.
Additional Information about the Proposed Transaction and Where to Find It
Fusion's shareholders 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,
This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote, consent or approval in any jurisdiction, nor shall there by any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. This communication has been prepared in respect of the transaction involving Fusion,
Contact:
Senior Director of Investor Relations & Corporate Communications
(617) 967-0207
cray@fusionpharma.com
(In thousands) | ||||||||
(Unaudited) | ||||||||
|
| |||||||
Cash, cash equivalents and investments | $ | 283,110 | $ | 247,344 | ||||
Total assets | 323,814 | 285,836 | ||||||
Total liabilities | 81,983 | 63,356 | ||||||
Total stockholders' equity | 241,831 | 222,480 |
FUSION PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Collaboration revenue | $ | — | $ | 28 | ||||
Operating expenses: | ||||||||
Research and development | 21,312 | 15,877 | ||||||
General and administrative | 14,548 | 9,006 | ||||||
Total operating expenses | 35,860 | 24,883 | ||||||
Loss from operations | (35,860) | (24,855) | ||||||
Other income (expense): | ||||||||
Interest income | 3,508 | 1,921 | ||||||
Interest expense | (1,852) | (1,223) | ||||||
Other income (expense), net | 297 | (145) | ||||||
Total other income (expense), net | 1,953 | 553 | ||||||
Loss before benefit for income taxes | (33,907) | (24,302) | ||||||
Income tax benefit | 237 | 11 | ||||||
Net loss | $ | (33,670) | $ | (24,291) | ||||
Unrealized (loss) gain on investments | (819) | 384 | ||||||
Comprehensive loss | $ | (34,489) | $ | (23,907) | ||||
Net loss per share—basic and diluted | $ | (0.40) | $ | (0.45) | ||||
Weighted-average common shares outstanding—basic and diluted | 83,775,652 | 53,775,985 |
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