Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused
on the development of first-in-class and best-in-class targeted
oncology therapies, today announced financial results for the third
quarter ended September 30, 2024, and provided a business
update.
“Immunome continues to advance its pipeline,” said Clay B.
Siegall, Ph.D., President and Chief Executive Officer. “Topline
data for the RINGSIDE Part B trial of AL102 is expected in the
second half of 2025, and IND submissions for IM-1021 and IM-3050
are on track.”
“Our discovery team is focused on discovering ADCs that
effectively pursue the novel targets we believe will define the
next generation of transformative cancer therapies. In particular,
the differentiated profile of HC74, our proprietary TOP1 payload,
offers exciting opportunities for portfolio expansion when combined
with our large repertoire of antibodies.”
Pipeline Highlights
Full enrollment for the Phase 3 RINGSIDE Part B study of AL102
for the treatment of desmoid tumors was completed in February 2024,
and Immunome expects to report topline data for RINGSIDE Part B in
the second half of 2025. In parallel, Immunome is performing
additional manufacturing and pharmacology work required to support
a new drug application filing for AL102.
Immunome also anticipates submitting INDs for IM-1021 and
IM-3050 in the first quarter of 2025, as previously disclosed.
Third Quarter 2024 Financial Results
- As of September 30, 2024, cash, cash equivalents and marketable
securities totaled $240.1 million. Immunome’s current cash runway
is expected to extend into 2026.
- Research and development expenses for the quarter ended
September 30, 2024 were $37.2 million, including stock-based
compensation costs of $1.8 million.
- In-process research and development expenses for the quarter
ended September 30, 2024 were $6.7 million. These expenses were
related to Immunome’s business development activity.
- General and administrative expenses for the quarter ended
September 30, 2024 were $9.5 million, including stock-based
compensation expense of $3.1 million.
- Immunome reported a net loss of $47.1 million for the quarter
ended September 30, 2024.
About Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed
to developing first-in-class and best-in-class targeted therapies
designed to improve outcomes for cancer patients. We are advancing
an innovative portfolio of therapeutics, drawing on leadership that
previously played key roles in the design, development and
commercialization of cutting-edge targeted cancer therapies,
including antibody-drug conjugates (ADCs). In addition to a
portfolio of discovery-stage ADCs, our pipeline includes AL102, a
gamma secretase inhibitor currently in a Phase 3 trial for
treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and
IM-3050, a FAP-targeted radioligand, both of which are the subject
of INDs expected to be submitted in the first quarter of 2025. For
more information, visit www.immunome.com.
Cautionary Statement Regarding Forward-Looking
Statements
Statements in this press release that are not purely historical
in nature are “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995. We use words
such as “expects,” “believe,” “opportunities,” “anticipates” and
similar expressions to identify these forward-looking statements.
These forward-looking statements include Immunome’s expected timing
for providing topline data for the Phase 3 RINGSIDE Part B trial;
Immunome’s expected timing for filing an IND for IM-1021 and
IM-3050; Immunome’s expectation that it will commence clinical
development of IM-1021 and IM-3050 in early 2025; the potential of
Immunome’s ADC targets to provide first-in-class or best-in-class
potential; and other statements regarding management’s intentions,
plans, beliefs, expectations or forecasts for the future. These
forward-looking statements are based on Immunome’s current
expectations and involve assumptions that may never materialize or
may prove to be incorrect; consequently, actual results may differ
materially from those expressed or implied in the statements due to
a number of factors, including the risk that Immunome will not be
able to realize the benefits of its strategic transactions; the
risk that regulatory approvals for Immunome’s programs and product
candidates are not obtained, are delayed or are subject to
unanticipated conditions; the risk that pre-clinical data may not
be predictive of clinical data; the risk that Immunome’s product
candidates and development candidates fail to achieve their
intended endpoints; uncertainties related to Immunome’s capital
requirements and Immunome’s expected cash runway; Immunome’s
ability to grow and successfully execute on its business plan; and
other risks and uncertainties indicated from time to time described
in Immunome’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2024, filed with the SEC on August 12, 2024, in Immunome’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2024, being filed with the SEC today, and in Immunome’s other
filings with the SEC. Except as required by law, Immunome assumes
no obligation and does not intend to update any forward-looking
statements included in this press release.
Immunome, Inc. Consolidated Balance Sheets
(Unaudited; In thousands) September 30, 2024
December 31, 2023 Assets Current assets: Cash and
cash equivalents $
155,568
$
98,679
Marketable securities
84,562
39,463
Prepaid expenses and other current assets
3,910
6,561
Total current assets
244,040
144,703
Property and equipment, net
7,172
2,073
Operating right-of-use assets
2,388
1,564
Restricted cash
100
100
Other long-term assets
3,198
100
Total assets $
256,898
$
148,540
Liabilities and stockholders’ equity Current liabilities:
Accounts payable $
3,518
$
3,311
Accrued expenses and other current liabilities
26,331
8,025
Deferred revenue, current
9,679
10,493
Total current liabilities
39,528
21,829
Deferred revenue, non-current
—
5,489
Operating lease liabilities, net of current portion
2,464
1,340
Total liabilities
41,992
28,658
Stockholders’ equity: Preferred stock
—
—
Common stock
6
4
Additional paid-in capital
650,351
342,663
Accumulated other comprehensive income
70
22
Accumulated deficit
(435,521
)
(222,807
)
Total stockholders’ equity
214,906
119,882
Total liabilities and stockholders’ equity $
256,898
$
148,540
Immunome, Inc. Consolidated Statements of
Operations (Unaudited; In thousands, except share and per
share amounts) Three Months Ended September 30,
Nine Months Ended September 30,
2024
2023
2024
2023
Collaboration revenue $
2,910
$
3,565
$
6,303
$
10,192
Operating expenses: In-process research and development
6,706
—
124,972
—
Research and development(1)
37,200
3,823
81,652
13,452
General and administrative(1)
9,526
4,375
22,509
11,617
Total operating expenses
53,432
8,198
229,133
25,069
Loss from operations
(50,522
)
(4,633
)
(222,830
)
(14,877
)
Interest income
3,422
288
10,116
705
Net loss $
(47,100
)
$
(4,345
)
$
(212,714
)
$
(14,172
)
Net loss per share, basic and diluted $
(0.78
)
$
(0.36
)
$
(3.72
)
$
(1.16
)
Weighted-average shares outstanding, basic and diluted
60,205,327
12,202,335
57,239,668
12,194,277
Comprehensive loss Net loss $
(47,100
)
$
(4,345
)
$
(212,714
)
$
(14,172
)
Unrealized loss on marketable securities
68
—
48
—
Comprehensive loss $
(47,032
)
$
(4,345
)
$
(212,666
)
$
(14,172
)
(1) Amounts include non-cash stock based compensation as
follows (in thousands):
Three Months Ended September
30, Nine Months Ended September 30,
2024
2023
2024
2023
Research and development $
1,820
$
466
$
3,244
$
1,323
General and administrative
3,072
617
7,034
2,017
Total share-based compensation expense $
4,892
$
1,083
$
10,278
$
3,340
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version on businesswire.com: https://www.businesswire.com/news/home/20241113523555/en/
Investor Contact: Max Rosett Chief Financial Officer
investors@immunome.com
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