Presented interim data from TATCIST trial
of FPI-2265 in mCRPC at the 2024 American Association for Cancer
Research (AACR) Annual Meeting
Signed definitive agreement to be acquired
by AstraZeneca for total transaction value of up to $2.4 billion; transaction expected to close in
the second quarter of 2024
HAMILTON, ON and BOSTON, May 7, 2024
/CNW/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a
clinical-stage oncology company focused on developing
next-generation radioconjugates (RCs) as precision medicines, today
reported financial results for the first quarter ended March 31, 2024, and provided an update on
clinical and corporate developments.
Chief Executive Officer John
Valliant, Ph.D., commented, "In the first quarter, we
demonstrated the potential of FPI-2265 to serve as an important new
treatment option for patients with mCRPC, presenting interim data
from the TATCIST trial at the 2024 AACR Annual Meeting that we
believe represent compelling early clinical activity and
tolerability data. We look forward to continuing to develop
FPI-2265 as the most advanced actinium-based prostate specific
membrane antigen (PSMA) targeting therapy and expect to begin a
Phase 2 dose optimization trial in the second quarter of this year,
followed by a Phase 3 global registrational trial in 2025. In
parallel, we are progressing our other clinical-stage programs as
part of our diverse portfolio of alpha-emitting RCs."
Corporate Update
On March 19, 2024, Fusion
announced that it entered into a definitive agreement to be
acquired by AstraZeneca. Under the terms of the definitive
agreement, AstraZeneca, through a subsidiary, will acquire all of
Fusion's outstanding shares pursuant to a plan of arrangement for a
price of $21.00 per share in cash at
closing plus a non-transferable contingent value right (CVR) of
$3.00 per share in cash payable upon
the achievement of a specified regulatory milestone.
On April 22, 2024 at 11:59pm, the applicable waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended,
expired with respect to the transaction, satisfying one of the
closing conditions. On May 1, 2024,
the Canadian Competition Bureau issued a no-action letter stating
that it would not challenge the transaction, satisfying another
closing condition. The transaction is expected to close in the
second quarter of 2024, subject to other customary closing
conditions, including the approval of Fusion
shareholders.
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 of December 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 of March 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
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.
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
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
business prospects and opportunities of Fusion and the Arrangement.
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 Fusion Pharmaceuticals Inc. ("Fusion"). 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. Expressed or implied
statements can be used to identify forward-looking statements when
made with respect to the 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; risks associated with the disruption of management's
attention from ongoing business operations due to the proposed
transaction; unknown liabilities and the risk of litigation and/or
regulatory actions related to the proposed transaction; the
Company's financial condition, liquidity, and potential drug
candidates, including any expressed or implied statements regarding
the successful development of FPI-2265; or any other clinical
candidate. More particularly and without limitation, this
communication contains forward-looking statements and information
regarding whether the proposed transaction will be completed,
whether the CVR Agreement (as defined in the Arrangement Agreement)
will be entered into, the anticipated benefits of the proposed
transaction for Fusion and its shareholders, whether approval will
be received under the Competition Act (Canada), as amended and whether the milestone
under the CVR Agreement will be achieved.
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 December 31, 2023, with the U.S. Securities
Exchange Commission ("SEC"), each as updated by Fusion's continuous
disclosure filings, which are available at www.sec.gov and at
www.sedarplus.com. 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 relied upon as
reflecting the Company's views, expectations, or beliefs at any
date subsequent to the date of this release. While Fusion may elect
to update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so, even if
the Company's estimates change.
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, SEC filings, and press
releases. The information that Fusion posts on this website could
be deemed to be material information. As a result, Fusion
encourages investors, media and others interested to review the
information that Fusion posts there on a regular basis.
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, AstraZeneca AB and 15863210 Canada Inc pursuant
to the terms of the Arrangement Agreement, and may be deemed to be
soliciting material relating to the transaction. In connection with
the transaction, Fusion has filed a management information circular
and proxy statement on Schedule 14A relating to a special meeting
of the shareholders with the SEC and Canadian Securities
Administrators ("CSA"). Fusion filed a management information
circular and proxy statement on April 25,
2024. Additionally, Fusion will file other relevant
materials in connection with the transaction with the SEC and the
CSA. Fusion's shareholders are urged to read the management
information circular and proxy statement and/or consent
solicitation documents regarding the transaction and any other
relevant materials carefully in their entirety when they become
available before making any voting or investment decision with
respect to the transaction because they will contain important
information about the transaction and the parties to the
Arrangement Agreement. The definitive management information
circular and proxy statement will be mailed to holders of Fusion's
shares. Fusion's shareholders will be able to obtain a copy of the
management information circular and proxy statement, as well as
other filings containing information about the transaction and the
parties to the Arrangement Agreement made by Fusion with the SEC
and CSA free of charge on EDGAR at www.sec.gov, on SEDAR+ at
www.sedarplus.com, or on Fusion's website at www.fusionpharma.com.
Information contained on, or that may be accessed through, the
websites referenced in this communication is not incorporated into
and does not constitute a part of this document. We have included
these website addresses only as inactive textual references and do
not intend them to be active links.
Contact:
Amanda
Cray
Senior Director of Investor Relations & Corporate
Communications
(617) 967-0207
cray@fusionpharma.com
FUSION
PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
March 31,
2024
|
|
|
December 31,
2023
|
|
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
March 31,
|
|
|
|
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
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-reports-first-quarter-2024-financial-results-and-announces-clinical-program-updates-302137953.html
SOURCE Fusion Pharmaceuticals