FPI-2265 (Ac-PSMA I&T) program enrolling
patients and on track for Q1 2024 update
Preliminary Phase 1 data for FPI-1434 expected
to be reported at the Society of Nuclear Medicine and Molecular
Imaging (SNMMI) Annual Meeting
Clinical progress across TAT pipeline
continues; first patient dosed in Phase 1 study of FPI-2059;
FPI-2068, a bispecific TAT jointly developed with AZ, IND has
cleared
FPI-1966 program to be discontinued due to
portfolio prioritization decision
$20.0 million
private placement financing with Federated Hermes Kaufmann Funds
extends cash runway into Q2 2025
HAMILTON, ON and BOSTON, May 11, 2023
/PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a
clinical-stage oncology company focused on developing
next-generation radiopharmaceuticals as precision medicines, today
announced financial results for the first quarter ended
March 31, 2023 and provided an update
on clinical and corporate developments.
Chief Executive Officer John
Valliant, Ph.D. commented, "In the first quarter, we further
diversified our pipeline of alpha-emitting radiopharmaceuticals
while progressing our multiple ongoing clinical programs. FPI-2265,
our recently acquired small molecule-based radiopharmaceutical
targeting prostate specific membrane antigen (PSMA) for the
treatment of metastatic castration-resistant prostate cancer
(mCRPC), holds the potential to be the first-to-market
actinium-based PSMA agent to meet a significant and growing need
for patients.
"Continuing our mission to build out a multi-asset portfolio, we
received investigational new drug (IND) clearance from the FDA for
FPI-2068, a bispecific antibody targeting EGFR-cMET, and the first
candidate nominated under our broad collaboration agreement with
AstraZeneca. We are also pleased that the first patient has been
dosed in the Phase 1 study of FPI-2059 targeting neurotensin
receptor 1 (NTSR1). These are both important milestones as we
demonstrate the potential to develop novel targets for
radiopharmaceuticals that reach beyond prostate and neuroendocrine
cancers.
"In parallel with the progress across our pipeline, we are
actively growing our actinium supply and manufacturing capabilities
to ensure our ability to execute on our multiple clinical programs,
most recently through our partnership with BWXT Medical and the
recent opening of Fusion's cGMP targeted alpha therapy (TAT)
manufacturing facility," Dr. Valliant concluded.
Portfolio Update
FPI-2265
In February 2023, Fusion acquired
an investigational new drug application (IND) for an ongoing Phase
2 clinical trial (the "TATCIST" trial) evaluating
225Ac-PSMA I&T, a small molecule targeting PSMA
expressed in prostate cancers. The alpha-emitting
radiopharmaceutical being evaluated in the TATCIST trial is now
known as FPI-2265.
The TATCIST trial is designed to evaluate 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 radiopharmaceuticals
such as PLUVICTO™. Fusion expects to report data on approximately
20 to 30 patients in the first quarter of 2024.
FPI-1434
In the Phase 1 trial, Fusion is exploring various dose levels of
FPI-1434 as well as two dosing regimens: one with FPI-1434 alone
("hot only"), and another in which a small dose of cold antibody
(naked IGF-1R antibody without the isotope) is administered prior
to each dose of FPI-1434 ("cold/hot"). The Company anticipates
reporting a clinical data update from the Phase 1 trial in a poster
presentation at the Society of Nuclear Medicine and Molecular
Imaging (SNMMI) Annual Meeting on Tuesday,
June 27th from 12:30 – 2:00pm CT, followed by a webcast investor
presentation (details to be provided).
Fusion expects to report molecular imaging, safety, and
pharmacokinetics (PK) for both the hot only and cold/hot dosing
regimens. Previously reported results from the cold antibody
sub-study (CASS), in conjunction with preclinical toxicity studies,
demonstrated improved biodistribution with the cold/hot regimen,
potentially leading to increased tumor absorbed dose compared to
healthy tissues. As a result, Fusion has prioritized patient dosing
with the cold/hot regimen. The Company expects to report the data
across all dose escalation cohorts, including the first cohort
(n=3) of the cold/hot regimen, which began after the hot only
regimen and the completion of the CASS.
Chief Medical Officer Dmitri
Bobilev, M.D. commented, "As the first industry study of its
kind, the FPI-1434 Phase 1 clinical trial has produced key
learnings about the development of antibody-based targeted alpha
therapies. Given the encouraging safety, dosimetry and PK results
suggesting an improved therapeutic index using the cold/hot
administration, this method has become the preferred way of
administration of FPI-1434 going forward. The study is currently
enrolling patients in the second cohort of the cold/hot dose arm of
the study."
FPI-2059
The Phase 1, non-randomized, open-label clinical trial of
FPI-2059 in patients with solid tumors expressing NTSR1 is intended
to investigate safety, tolerability and pharmacokinetics and to
establish the recommended Phase 2 dose. Site initiation and patient
screening is ongoing. Fusion plans to provide guidance on timelines
for the FPI-2059 program following site activations and initial
experience with patient screening and patient enrollment.
FPI-2068
In April 2023, Fusion announced
U.S. Food and Drug Administration (FDA) clearance of IND
applications for [225Ac]-FPI-2068 (FPI-2068) and
corresponding imaging analogue [111In]-FPI-2107
(FPI-2107). Fusion is jointly developing FPI-2068 with AstraZeneca
under the companies' multi-asset collaboration agreement. FPI-2068
is a targeted alpha therapy (TAT) designed to deliver actinium-225
to various solid tumors that express EGFR and 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. Fusion plans to provide additional guidance on
timelines for the FPI-2068 program following initial experience
with patient screening to better predict the cadence of patient
enrollment.
FPI-1966
Fusion announced that it is discontinuing the Phase 1,
non-randomized, open-label clinical trial of FPI-1966 in patients
with solid tumors expressing FGFR3. As part of a portfolio
prioritization decision to focus resources on the Company's lead
program, FPI-2265, and assessment of the relative portfolio value
contributions of our clinical assets, Fusion no longer plans to
pursue development of FPI-1966.
Recent Updates
- In May, Fusion announced the opening of its state-of-the-art
radiopharmaceutical manufacturing facility. The 27,000 square foot
good manufacturing practice (GMP) compliant facility, which is
located adjacent to the Company's research and development labs,
has clinical and commercial manufacturing scale capabilities
designed to support the Company's growing pipeline of targeted
alpha therapies (TATs). The facility is expected to be fully
operational in 2024.
- In April, Fusion announced the clearance of investigational new
drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068)
and corresponding imaging analogue [111In]-FPI-2107
(FPI-2107) to the U.S. Food and Drug Administration (FDA).
Private Placement Financing
Fusion has agreed to sell an aggregate of approximately 4.8
million common shares to Federated Hermes Kaufmann Funds in a
private placement in public equity financing (the "Offering"). The
Offering is expected to result in gross proceeds to Fusion of
approximately $20.0 million, before
deducting offering expenses payable by Fusion.
Pursuant to the terms of the securities purchase agreement, at
the closing of the Offering, Fusion will issue approximately 4.8
million of its common shares at a price of $4.18 per share. The closing of the Offering is
subject to customary closing conditions and is expected to occur on
or about May 15, 2023.
Upon the closing of the Offering, Fusion anticipates having
sufficient cash, cash equivalents, and investments to fund its
planned operating expenses and capital expenditure requirements
into the second quarter of 2025.
The offer and sale of the foregoing shares are being made in a
transaction not involving a public offering and have not been
registered under the Securities Act of 1933, as amended (the
"Securities Act"). The shares being issued in the private placement
may not be offered or sold in the United
States or Canada absent
registration or pursuant to an exemption from the registration
requirements of the Securities Act and applicable state securities
laws or pursuant to an exemption from the prospectus requirements
of Canadian securities laws, as applicable. Fusion has agreed to
file a registration statement with the Securities and Exchange
Commission covering the resale of the shares acquired by the
investors in the private placement.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the securities, nor shall there be
any sale of the securities in any state in which such offer or sale
would be unlawful prior to the registration or qualification under
the securities laws of such state. Any offering of the shares under
the resale registration statement will only be by means of a
prospectus.
First Quarter 2023 Financial Results
- Cash and Investments: As of March 31,
2023, Fusion held cash, cash equivalents and investments of
$221.2 million, compared to cash,
cash equivalents and investments of $186.6
million as of December 31,
2022. The increase in cash, cash equivalents and investments
was attributable to $60.0 million of
gross proceeds received from a private placement financing that
closed in February 2023.
- Collaboration Revenue: For the first quarter of 2023, Fusion
recorded less than $0.1 million of
revenue under the AstraZeneca collaboration agreement, compared to
$0.6 million for the same period in
2022.
- R&D Expenses: Research and development expenses for the
first quarter of 2023 were $15.9
million, compared to $12.7
million for the same period in 2022. The increase was
primarily due to costs associated with the acquisition of the
FPI-2265 Phase 2 clinical trial during the first quarter of 2023,
as well as an increase in personnel-related costs.
- G&A Expenses: General and administrative expenses for the
first quarter of 2023 were $9.0
million, compared to $8.4
million for the same period in 2022. The increase was
primarily due to increased corporate and patent-related legal
expenses, as well as an increase in personnel-related costs.
- Net Loss: For the first quarter of 2023, Fusion reported a net
loss of $24.3 million, or
$0.45 per share, compared with a net
loss of $19.9 million, or
$0.46 per share, for the same period
in 2022.
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 to selectively deliver the
alpha emitting payloads to tumors. Fusion's clinical portfolio
includes: FPI-2265 targeting prostate specific membrane antigen
(PSMA) for metastatic castration resistant prostate cancer
currently in a Phase 2 trial; FPI-1434 targeting insulin-like
growth factor 1 receptor currently in a Phase 1 trial; FPI-1966,
targeting the fibroblast growth factor receptor 3 (FGFR3),
currently in a Phase 1 trial; and FPI-2059, a small molecule
targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1
trial. In addition to a robust proprietary pipeline, Fusion has a
collaboration with AstraZeneca to jointly develop novel targeted
alpha therapies (TATs) and combination programs between Fusion's
TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and
immuno-oncology agents. The Company recently received IND clearance
for FPI-2068, the first novel TAT under the collaboration, which
targets EGFR-cMET. Fusion has also entered into a collaboration
with Merck to evaluate FPI-1434 in combination with Merck's
KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing
IGF-1R. To support Fusion's growing pipeline of TATs, the Company
has signed strategic actinium supply agreements with TRIUMF,
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 Fusion Pharmaceuticals Inc.'s (the "Company")
future business and financial performance. 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 Company's potential drug candidates, including
any expressed or implied statements regarding the successful
development of its product candidates. 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 to the clinic, to the regulatory process or to
commercialization; management's expectations could be affected by
unexpected patient recruitment delays, regulatory actions or
delays, or changes in the competitive landscape; uncertainties
relating to, or unsuccessful results of, clinical trials, including
additional data relating to the ongoing clinical trials evaluating
its product candidates; the closing of the Offering; 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; the ability of the
Company to attract and retain qualified personnel; competition in
general; and the Company's ability to obtain, maintain and enforce
patent and other intellectual property protection for its product
candidates and its discoveries. 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-K for the year ended December 31,
2022, as filed with 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)
|
|
|
|
March 31,
2023
|
|
|
December 31,
2022
|
|
Cash, cash equivalents
and investments
|
|
$
|
221,182
|
|
|
$
|
186,635
|
|
Total assets
|
|
|
266,551
|
|
|
|
219,064
|
|
Total
liabilities
|
|
|
65,718
|
|
|
|
56,843
|
|
Total stockholders'
equity
|
|
|
200,833
|
|
|
|
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
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Collaboration
revenue
|
|
$
|
28
|
|
|
$
|
585
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
|
15,877
|
|
|
|
12,661
|
|
General and
administrative
|
|
|
9,006
|
|
|
|
8,449
|
|
Total operating
expenses
|
|
|
24,883
|
|
|
|
21,110
|
|
Loss from
operations
|
|
|
(24,855)
|
|
|
|
(20,525)
|
|
Other income
(expense):
|
|
|
|
|
|
|
Interest
income
|
|
|
1,921
|
|
|
|
83
|
|
Interest
expense
|
|
|
(1,223)
|
|
|
|
—
|
|
Other (expense)
income, net
|
|
|
(145)
|
|
|
|
478
|
|
Total other income,
net
|
|
|
553
|
|
|
|
561
|
|
Loss before benefit for
income taxes
|
|
|
(24,302)
|
|
|
|
(19,964)
|
|
Income tax
benefit
|
|
|
11
|
|
|
|
55
|
|
Net loss
|
|
$
|
(24,291)
|
|
|
$
|
(19,909)
|
|
Unrealized gain (loss)
on investments
|
|
|
384
|
|
|
|
(463)
|
|
Comprehensive
loss
|
|
$
|
(23,907)
|
|
|
$
|
(20,372)
|
|
|
|
|
|
|
|
|
Net loss per
share—basic and diluted
|
|
$
|
(0.45)
|
|
|
$
|
(0.46)
|
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding—basic and diluted
|
|
|
53,775,985
|
|
|
|
43,170,076
|
|
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SOURCE Fusion Pharmaceuticals