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 American Association for Cancer
Research (AACR) Annual Meeting in April
Fusion is now producing and shipping
clinical doses of FPI-2265 from its state-of-the-art GMP
manufacturing facility
HAMILTON,
ON and BOSTON, March 20,
2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc.
(Nasdaq: FUSN), a clinical-stage oncology company focused on
developing next-generation radiopharmaceuticals as precision
medicines, today reported financial results for the fourth quarter
and full year ended December 31,
2023, and provided an update on clinical and corporate
developments.
Chief Executive Officer John
Valliant, Ph.D., commented, "We entered 2024 with strong
momentum focused on execution to advance our pipeline of targeted
alpha therapies, and we are pleased to recently have achieved
several critical milestones. For our lead program, FPI-2265, we
expect to initiate the Phase 2 portion of the registrational
program in metastatic castration-resistant prostate cancer (mCRPC)
in the second quarter of this year. Acknowledging the substantial
and expanding market for patients in the post-PLUVICTO™ setting we
believe FPI-2265, which is positioned to be the first
actinium-based PSMA targeted radiopharmaceutical to market, will
effectively address a crucial unmet need for patients with
progressive disease. We look forward to presenting data from the
TATCIST trial at AACR in April.
Dr. Valliant continued, "We also continue to advance our other
clinical-stage programs, including the ongoing Phase 1 study of
FPI-1434, which has demonstrated a promising safety profile and
early evidence of antitumor activity. We expect to provide an
update on this program around mid-year 2024. Underpinning our
platform, which has produced a robust pipeline of targeted alpha
therapies, is our state-of-the-art GMP manufacturing facility now
operational and producing clinical doses of FPI-2265. With a strong
balance sheet and secured actinium supply, we are well positioned
to execute on our commitment of bringing this next generation of
radiopharmaceuticals to patients in need."
Corporate Update
On March 19, 2024, Fusion
announced the Company has entered into a definitive agreement to be
acquired by AstraZeneca. Under the terms of the 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.
The upfront cash portion of the consideration represents a
transaction value of approximately $2
billion, a 97% premium to Fusion's closing market price of
$10.64 on March 18, 2024. Combined, the upfront and maximum
potential contingent value payments represent, if achieved, a
transaction value of approximately $2.4
billion, a 126% premium to Fusion's closing market price on
March 18, 2024. As part of the
transaction, AstraZeneca will acquire the cash, cash equivalents
and short-term investments on Fusion's balance sheet, which totaled
$234 million as of December 31, 2023.
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 with
Heidelberg University and Euratom represented by the European
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 in August 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 of December 31,
2022. Fusion expects its existing cash, cash equivalents and
investments as of December 31, 2023,
together with net proceeds from sales of common shares under the
Company's at-the-market equity offering program received in January
and February 2024 and net proceeds of
$14.9 million from a draw down under
the Company's existing debt facility in January 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
American Association for Cancer Research (AACR) Annual Meeting
being held in San Diego, CA, April 5-10, 2024.
- 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
Fusion Pharmaceuticals is a clinical-stage oncology company
focused on developing next-generation radiopharmaceuticals as
precision medicines. 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 prostate specific membrane antigen for
metastatic castration resistant prostate cancer currently in a
Phase 2 trial and novel targeted alpha therapies (TATs) including
next-generation antibody drug conjugates (ADCs). Fusion has a
collaboration with AstraZeneca to jointly develop novel TATs and
combination programs between Fusion's TATs and AstraZeneca's DNA
damage response inhibitors and immuno-oncology agents. Fusion has a
fully operational Good Manufacturing Practice compliant
state-of-the-art radiopharmaceutical manufacturing facility to meet
supply demand for the Company's growing pipeline of TATs. The
Company has strategic actinium supply agreements with Niowave, Inc.
and BWXT Medical.
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 Fusion Pharmaceuticals Inc. (the "Company"). For this purpose,
any statements contained herein that are not statements of
historical fact may be deemed forward-looking statements. Without
limiting the foregoing, the words "expect," "plans," "anticipates,"
"intends," "will," and similar expressions are also intended to
identify forward-looking statements, as are expressed or implied
statements 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; and 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 FPI-1434. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of risks and uncertainties, including but
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; the Company's ability to obtain additional funding
required to conduct its research, development and commercialization
activities; changes in the Company's business plan or objectives;
competition in general; the Company's ability to obtain, maintain
and enforce patent and other intellectual property protection for
its product candidates and its discoveries; and the Company
partners' ability to advance any technology relating to
actinium-225 to development. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors
that may cause actual results to be materially different from any
future results, performance or achievements expressed or implied by
such statements. These and other risks which may impact
management's expectations are described in greater detail under the
heading "Risk Factors" in the Company's quarterly report on Form
10-Q for the period ended September 30,
2023, as filed with the Securities and Exchange Commission
(the "SEC") and in any subsequent periodic or current report 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 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.
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, 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.
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)
|
|
|
|
|
|
December 31,
|
|
|
|
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
|
|
FUSION
PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(In thousands,
except share and per share amounts)
(Unaudited)
|
|
|
|
Three Months Ended
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
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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SOURCE Fusion Pharmaceuticals