- Integration of AL102 and IM-1021 completed
- Topline data for Phase 3 RINGSIDE trial of AL102 expected in
second half of 2025
- IM-1021 and IM-3050 IND submissions expected in first quarter
of 2025
Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused
on developing first-in-class and best-in-class targeted cancer
therapies, today announced financial results for the first quarter
ended March 31, 2024, and provided a business update.
“Immunome continues to build momentum. We have completed the
integration of AL102 and are executing activities necessary for
regulatory submissions,” said Clay B. Siegall, Ph.D., President and
Chief Executive Officer. “We have also completed the integration of
IM-1021 and are advancing that program and IM-3050 towards clinical
trials.”
Dr. Siegall continued, “In addition, we are working internally
to design and develop additional next-generation ADC technology.
Those efforts are complemented by our ongoing business development
efforts, which seek to identify and procure high-quality
technologies and clinical programs. Both our internal and external
efforts are focused on expanding Immunome’s pipeline with
additional programs that have first-in-class or best-in-class
potential and can improve the lives of cancer patients.”
Pipeline Highlights
The purchase of AL101 and AL102 from Ayala Pharmaceuticals
closed on March 25, 2024. Full enrollment for the Phase 3 RINGSIDE
Part B study of AL102 for the treatment of desmoid tumors was
completed in February 2024. Immunome expects to report topline data
for RINGSIDE Part B in the second half of 2025. In parallel,
Immunome continues to perform additional manufacturing and
pharmacology work required to support a new drug application filing
for AL102.
Immunome anticipates submitting INDs for two preclinical
candidates in the first quarter of 2025: IM-1021, a ROR1 ADC, and
IM-3050, a FAP-targeted RLT.
First Quarter 2024 Financial Results
- As of March 31, 2024, cash, cash equivalents and marketable
securities totaled $309.7 million. Immunome’s current cash runway
is expected to extend into 2026.
- Research and development expenses for the quarter ended March
31, 2024 were $15.4 million, including stock-based compensation
costs of $0.4 million.
- In-process research and development expenses for the quarter
ended March 31, 2024 were $112.0 million. These expenses were
related to Immunome’s acquisition of AL101 and AL102 from Ayala
Pharmaceuticals, Inc. and the exclusive license of IM-1021 and
related ADC platform technology from Zentalis Pharmaceuticals,
Inc., both of which closed in the quarter ended March 31,
2024.
- General and administrative expenses for the quarter ended March
31, 2024 were $6.0 million, including stock-based compensation
expense of $1.8 million.
- Immunome reported a net loss of $129.5 million, or basic and
diluted net loss per share attributable to common stockholders of
$2.51, for the quarter ended March 31, 2024.
About Immunome, Inc.
Immunome is a biotechnology company dedicated to developing
first-in-class and best-in-class targeted cancer therapies. Our
portfolio pursues each target with a modality appropriate to its
biology, including small molecules, ADCs, and RLTs. We believe that
pursuing underexplored targets with appropriate drug modalities
leads to transformative therapies. Our proprietary memory B cell
hybridoma technology allows for the rapid screening and functional
characterization of novel antibodies and targets.
For more information, visit www.immunome.com or follow us on
Twitter and LinkedIn.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements contained in this communication regarding
matters that are not historical facts, are forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995 (the “PSLRA”). We use words such as
“may,” “could,” “potential,” “will,” “plan,” “believe,” “expect,”
and similar expressions to identify these forward-looking
statements that are intended to be covered by the safe-harbor
provisions of the PSLRA. These forward-looking statements include,
but are not limited to, Immunome’s expectation to report topline
data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the
second half of 2025; Immunome’s expected timeline for submitting
INDs for IM-3050 and IM-1021 in the first quarter of 2025;
Immunome’s expected cash runway; Immunome’s ability to expand its
pipeline through both internal and external efforts; and other
statements regarding management’s intentions, plans, beliefs,
expectations or forecasts for the future. No forward-looking
statement can be guaranteed, and actual results may differ
materially from those projected. Such forward-looking statements
are based on Immunome’s expectations and involve risks and
uncertainties; consequently, actual results may differ materially
from those expressed or implied in the statements due to a number
of factors, including, but not limited to, the risk that Immunome
will not be able to realize the benefits of its strategic
transactions; Immunome’s ability to grow and successfully execute
on its business plan, including the development and
commercialization of its pipeline and integration of newly acquired
assets; changes in the applicable laws or regulations; the
possibility that Immunome may be adversely affected by other
economic, business, and/or competitive factors; 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 interim results of a clinical trial
do not necessarily predict final results; potential delays in the
commencement, enrollment and completion of clinical trials and the
reporting of data therefrom; the risk that Immunome’s product and
development candidates fail to achieve their intended endpoints;
the complexity of numerous regulatory and legal requirements that
Immunome needs to comply with to operate its business; the reliance
on Immunome’s management; the prior experience and successes of the
Immunome’s management team not being indicative of any future
success; uncertainties related to Immunome’s capital requirements
and Immunome’s expected cash runway; the failure to obtain,
adequately protect, maintain or enforce Immunome’s intellectual
property rights; and other risks and uncertainties indicated from
time to time described in Immunome’s Annual Report on Form 10-K for
the year ended December 31, 2023, filed with the SEC on March 26,
2024, in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter
ended March 31, 2024, being filed with the SEC today, and in
Immunome’s other filings with the SEC. Immunome cautions that the
foregoing list of factors is not exclusive and not to place undue
reliance upon any forward-looking statements which speak only as of
the date made. Moreover, Immunome operates in a very competitive
and rapidly changing environment. New risks emerge from time to
time. Except as required by law, Immunome does not undertake any
obligation to update publicly any forward-looking statements for
any reason after the date of this press release to conform these
statements to actual results or to changes in their
expectations.
Immunome, Inc. Condensed Consolidated Balance Sheets
(Unaudited; In thousands) March 31, 2024
December 31, 2023 Assets Current assets: Cash and
cash equivalents $
269,723
$
98,679
Marketable securities
39,983
39,463
Prepaid expenses and other current assets
3,620
6,561
Total current assets
313,326
144,703
Property and equipment, net
4,302
2,073
Operating right-of-use assets
1,458
1,564
Restricted cash
100
100
Other long-term assets
568
100
Total assets $
319,754
$
148,540
Liabilities and stockholders’ equity Current liabilities:
Accounts payable $
7,179
$
3,311
Accrued expenses and other current liabilities
10,844
8,025
Deferred revenue, current
12,745
10,493
Total current liabilities
30,768
21,829
Deferred revenue, non-current
2,208
5,489
Operating lease liabilities, net of current portion
1,206
1,340
Total liabilities
34,182
28,658
Stockholders’ equity: Preferred stock
—
—
Common stock
6
4
Additional paid-in capital
637,861
342,663
Accumulated other comprehensive income
4
22
Accumulated deficit
(352,299
)
(222,807
)
Total stockholders’ equity
285,572
119,882
Total liabilities and stockholders’ equity $
319,754
$
148,540
Immunome, Inc. Condensed Consolidated Statements of
Operations and Comprehensive Loss (Unaudited; In thousands,
except share and per share amounts)
Three Months Ended March 31,
2024
2023
Collaboration revenue $
1,029
$
2,364
Operating expenses: In-process research and
development
111,954
—
Research and development(1)
15,369
3,913
General and administrative(1)
6,005
2,922
Total operating expenses
133,328
6,835
Loss from operations
(132,299
)
(4,471
)
Interest income
2,807
201
Net loss $
(129,492
)
$
(4,270
)
Net loss per share, basic and diluted $
(2.51
)
$
(0.35
)
Weighted-average shares outstanding, basic and diluted
51,544,383
12,182,478
Comprehensive loss Net loss $
(129,492
)
$
(4,270
)
Unrealized loss on marketable securities
(18
)
—
Comprehensive loss $
(129,510
)
$
(4,270
)
(1) Amounts include non-cash, stock-based
compensation expense as follows (in thousands):
Three Months Ended March
31,
2024
2023
Research and development $
383
$
430
General and administrative
1,776
794
Total share-based compensation expense $
2,159
$
1,224
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version on businesswire.com: https://www.businesswire.com/news/home/20240514845046/en/
Investor Contact: Max Rosett Chief Financial Officer
investors@immunome.com
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