Preliminary data for FPI-2265
(225Ac-PSMA I&T) in approximately 20 to 30 patients
on track for Q1 2024
Data from Cohort 2 of the FPI-1434 Phase 1
study anticipated around
year-end 2023
FPI-2068, a bispecific IgG-based targeted
alpha therapy for solid tumors that co-express EGFR-cMET, developed
in collaboration with AstraZeneca, demonstrates strong preclinical
anti-tumor activity
Fusion's state-of-the-art
radiopharmaceutical manufacturing facility on track to begin
producing clinical doses in early 2024
HAMILTON, ON and BOSTON, Nov. 7, 2023
/CNW/ -- 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 third quarter ended
September 30, 2023 and provided an
update on clinical and corporate developments.
Chief Executive Officer John
Valliant, Ph.D., commented, "In 2023, Fusion has focused on
transitioning to a later stage company leading the development of
next-generation radiopharmaceuticals that leverage the potency and
precision of alpha-emitting particles. We believe in the potential
of our diversified pipeline of targeted alpha therapy (TAT)
programs, our AstraZeneca collaboration, multiple actinium supply
partnerships and our proprietary, state-of-the-art
radiopharmaceutical manufacturing facility to produce innovative
therapies for patients with multiple cancer types and create
significant value.
Dr. Valliant continued, "In the third quarter, we advanced
patient enrollment in our Phase 2 clinical trial of FPI-2265, a
small molecule-based TAT targeting prostate specific membrane
antigen (PSMA) for the treatment of metastatic castration-resistant
prostate cancer (mCRPC) which is positioned to be the first
actinium-based PSMA TAT to market. We are on track to report data
on approximately 20 to 30 patients in the first quarter of 2024.
Following encouraging recently reported data and continued momentum
in the PSMA-targeted radiopharmaceuticals space, we are
increasingly excited about the substantial market and patient need
that FPI-2265 could address. We are also on track to share data
from the second cohort in our Phase 1 study of FPI-1434 in patients
with solid tumors expressing IGF-1R around the end of this year. In
addition, we were pleased to share preclinical data at the
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics on FPI-2068, a jointly developed TAT with
AstraZeneca targeting solid tumors expressing EGFR-cMET, which
showed anti-tumor efficacy and confirmatory evidence of FPI-2068's
mechanism of action. These data were the basis for our
investigational new drug (IND) clearance earlier this year, and we
look forward to progressing the program into the previously
announced Phase 1 clinical study.
"Finally, with manufacturing and supply chain expertise as a
core foundation of Fusion, we are pleased with the progress in
validation of our proprietary GMP radiopharmaceutical manufacturing
facility, which we expect will be capable of producing up to
100,000 doses of drug per year. We look forward to beginning to
produce clinical doses early in 2024 and are confident in the
diversified supply chain we have invested in which supports our
ability to deliver therapies to patients in need."
Portfolio Update
FPI-2265
In February 2023, Fusion acquired
an IND for an ongoing Phase 2 clinical trial (the "TATCIST" trial)
evaluating 225Ac-PSMA I&T, a small molecule
targeting PSMA expressed on 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 including safety and
efficacy results (PSA50 responses, ORR, and rPFS).
FPI-1434
The Phase 1, multi-center, open-label clinical 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. Interim Phase 1 data
were presented at the SNMMI Annual Meeting in June 2023. Three patients were dosed in Cohort 1
at a dose of 15 kBq/kg following pre-administration of cold
antibody. In this first cohort, cold/hot dosing was observed to be
safe with no treatment-related serious adverse events (SAEs) or
dose limiting toxicities (DLTs). Results demonstrated
pre-administration of cold antibody improved tumor uptake while
also reducing hematological toxicity observed in the hot only
dosing arm, potentially enhancing the therapeutic index. When
normalized to 15 kBq/kg, the average lesion absorbed dose and
dose/volume in the cold/hot arm were nearly double the level
compared to hot only. Further, the 15 kBq/kg cold/hot dosing arm
showed comparable systemic exposure to approximately 40 kBq/kg of a
hot only dose but with an improved hematological profile as
measured by changes in platelet count.
Fusion is currently enrolling Cohort 2 in the cold/hot dosing
regimen at 25 kBq/kg. The Company expects to report data from this
cohort around year-end 2023.
FPI-2059
The Phase 1, multi-center, open-label clinical trial is 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. Patient enrollment and
dosing are ongoing. 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
Fusion announced 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 bispecific
IgG-based 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.
Recent News
- In October, Fusion announced the appointment of Jeremy Bender, Ph.D., M.B.A., Teresa Bitetti, M.B.A. and David Meek to its Board of Directors.
- In October, Fusion presented preclinical data on FPI-2068 at
the 2023 AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics, held October 11-15 in Boston.
Third Quarter 2023 Financial Results
- Cash and Investments: As of September
30, 2023, Fusion held cash, cash equivalents and investments
of $207.3 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 September 30, 2023
will be sufficient to fund operations into the second quarter of
2025.
- Collaboration Revenue: For the third quarter of 2023, Fusion
recorded $2.0 million of revenue
under the AstraZeneca collaboration agreement, compared to
$0.2 million for the same period in
2022.
- R&D Expenses: Research and development expenses for the
third quarter of 2023 were $14.6
million, compared to $16.6
million for the same period in 2022. The decrease was
primarily due to a decrease in FPI-1966 program-related activities
as a result of the Company ceasing clinical development for the
program and a decrease in manufacturing-related costs for our Phase
1 clinical trial of FPI-1434, partially offset by program expenses
for our Phase 2 clinical trial of FPI-2265.
- G&A Expenses: General and administrative expenses for the
third quarter of 2023 were $6.8
million, compared to $7.4
million for the same period in 2022. The decrease was
primarily due to a decrease in corporate and patent related legal
expenses.
- Net Loss: For the third quarter of 2023, Fusion reported a net
loss of $17.3 million, or
$0.25 per share, compared with a net
loss of $24.0 million, or
$0.55 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; 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. 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; and competition in general. 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 quarter ended
June 30, 2023, 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)
|
|
|
|
September 30,
2023
|
|
|
December 31,
2022
|
|
Cash, cash equivalents
and investments
|
|
$
|
207,279
|
|
|
$
|
186,635
|
|
Total assets
|
|
|
253,377
|
|
|
|
219,064
|
|
Total
liabilities
|
|
|
64,906
|
|
|
|
56,843
|
|
Total stockholders'
equity
|
|
|
188,471
|
|
|
|
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
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Collaboration
revenue
|
|
$
|
2,006
|
|
|
$
|
166
|
|
|
$
|
2,068
|
|
|
$
|
1,321
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
14,585
|
|
|
|
16,551
|
|
|
|
49,456
|
|
|
|
41,288
|
|
General and
administrative
|
|
|
6,810
|
|
|
|
7,420
|
|
|
|
23,569
|
|
|
|
23,650
|
|
Total operating
expenses
|
|
|
21,395
|
|
|
|
23,971
|
|
|
|
73,025
|
|
|
|
64,938
|
|
Loss from
operations
|
|
|
(19,389)
|
|
|
|
(23,805)
|
|
|
|
(70,957)
|
|
|
|
(63,617)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
2,818
|
|
|
|
572
|
|
|
|
7,234
|
|
|
|
853
|
|
Interest
expense
|
|
|
(1,325)
|
|
|
|
(382)
|
|
|
|
(3,830)
|
|
|
|
(633)
|
|
Other income
(expense), net
|
|
|
391
|
|
|
|
(1,159)
|
|
|
|
326
|
|
|
|
(1,095)
|
|
Total other income
(expense), net
|
|
|
1,884
|
|
|
|
(969)
|
|
|
|
3,730
|
|
|
|
(875)
|
|
Loss before benefit for
income taxes
|
|
|
(17,505)
|
|
|
|
(24,774)
|
|
|
|
(67,227)
|
|
|
|
(64,492)
|
|
Income tax
benefit
|
|
|
253
|
|
|
|
761
|
|
|
|
509
|
|
|
|
1,497
|
|
Net loss
|
|
$
|
(17,252)
|
|
|
$
|
(24,013)
|
|
|
$
|
(66,718)
|
|
|
$
|
(62,995)
|
|
Unrealized loss on
investments
|
|
|
(589)
|
|
|
|
(196)
|
|
|
|
(372)
|
|
|
|
(1,141)
|
|
Comprehensive
loss
|
|
$
|
(17,841)
|
|
|
$
|
(24,209)
|
|
|
$
|
(67,090)
|
|
|
$
|
(64,136)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share—basic and diluted
|
|
$
|
(0.25)
|
|
|
$
|
(0.55)
|
|
|
$
|
(1.06)
|
|
|
$
|
(1.45)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding—basic and diluted
|
|
|
69,050,107
|
|
|
|
43,683,738
|
|
|
|
63,090,406
|
|
|
|
43,405,566
|
|
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SOURCE Fusion Pharmaceuticals