- Topline data for Phase 3 RINGSIDE trial of AL102 expected in
first quarter of 2025
- IM-1021 and IM-3050 IND filings expected in first quarter of
2025
- Current cash expected to fund activities into 2026
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 full year
ended December 31, 2023, and provided an overview of recent
developments.
“2023 was a transformative year for Immunome as we closed the
merger with Morphimmune, advanced our pipeline and expanded the
company’s leadership team,” said Clay B. Siegall, Ph.D., President
and Chief Executive Officer. “These accomplishments laid the
groundwork for a productive start to 2024, including the
acquisition of two promising assets and a successful
financing.”
Dr. Siegall continued, “We are focused on efficiently developing
our four existing assets and expanding our pipeline. We expect to
add novel antibody-drug conjugates (ADCs) and radioligand therapies
(RLTs) to the pipeline through internal discovery efforts while
continuing to evaluate opportunities to acquire high-quality assets
on favorable financial terms. We are well-positioned to develop
best-in-class or first-in-class therapies to improve the lives of
cancer patients.”
Pipeline Highlights
The purchase of AL102 from Ayala Pharmaceuticals closed on March
25, 2024. Immunome expects to report topline data for the ongoing
Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of
2025. Ayala previously announced the full enrollment of RINGSIDE in
February 2024. In parallel, Immunome is evaluating and performing
additional manufacturing and pharmacology work required to support
an NDA submission of AL102.
Immunome’s preclinical pipeline includes IM-1021, a ROR1 ADC;
IM-3050, a FAP-targeted RLT; and IM-4320, an anti-IL-38
immunotherapy candidate. Immunome anticipates submitting
investigational new drug applications (INDs) for IM-3050 and
IM-1021 in the first quarter of 2025. Anticipated timing for an IND
for IM-4320 will be shared at a later date.
Highlights from 2023 and early 2024
- Successfully completed an underwritten offering of 11.5M shares
priced at $20 per share for gross proceeds of $230.0M in February
2024, providing capital that is expected to support completion of
the RINGSIDE trial and advancement of IM-1021, IM-3050 and IM-4320
into clinic. Immunome’s current cash runway is expected to extend
into 2026.
- Acquired AL102, a Phase 3 gamma secretase inhibitor with
best-in-class potential, from Ayala Pharmaceuticals in March
2024.
- Exclusively licensed IM-1021 (formerly known as ZPC-21), a
preclinical ROR1 ADC with first-in-class potential, as well as the
underlying ADC linker-payload technology, from Zentalis in January
2024.
- Nominated IM-3050 as a FAP RLT candidate with first-in-class
potential in December 2023.
- Completed the acquisition of Morphimmune, Inc, a concurrent
PIPE of $125 million, and the transition to Clay Siegall, Ph.D. as
President and CEO in October 2023.
- Filled leadership positions post-merger, including key members
of the Executive Committee and five VP/SVP roles.
Full-year 2023 Financial Results
- As of December 31, 2023, cash, cash equivalents and marketable
securities totaled $138.1 million, which does not include gross
proceeds of $230 million from the February financing.
- Research and development expenses for the year ended December
31, 2023 were $23.1 million. In-process research and development
expenses for the year ended December 31, 2023 were $80.8
million.
- General and administrative expenses for the year ended December
31, 2023 were $19.7 million.
- Immunome reported a net loss of $106.8 million, or basic and
diluted net loss per share attributable to common stockholders of
$5.38, for the year ended December 31, 2023.
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, RLTs and immunotherapies.
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 and
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,” “goal,”
“optimistic,” 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, statements regarding
immunome’s expectation to add novel ADCs and RLTs to its pipeline;
Immunome’s expectation to report topline data for the ongoing Phase
3 RINGSIDE Part B trial of AL102 in the first quarter of 2025;
Immunome’s expected timeline for filing INDs for IM-3050 and
IM-1021 in the first quarter of 2025; Immunome’s expectation that
it will share a date for filing an IND for IM-4320; Immunome’s
expectation that the funds from the February financing will support
completion of the RINGSIDE trial and advancement of IM-1021,
IM-3050 and IM-4320 into clinic; Immunome’s expected cash runway;
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; 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 our
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 exhibit
99.2 filed with Immunome’s Current Report on Form 8-K with
Securities and Exchange Commission (“SEC”) on February 13, 2024,
and in Immunome’s Annual Report on Form 10-K for the year ended
December 31, 2023, being filed with the SEC later 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.
Consolidated Balance
Sheets
(in thousands, except share
and per share amounts)
December 31, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
98,679
$
20,323
Marketable securities
39,463
—
Prepaid expenses and other current
assets
6,561
2,326
Total current assets
144,703
22,649
Property and equipment, net
2,073
681
Operating right-of-use asset, net
1,564
284
Restricted cash
100
100
Deferred offering costs
—
332
Other long-term assets
100
—
Total assets
$
148,540
$
24,046
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
3,311
$
2,400
Accrued expenses and other current
liabilities
8,025
4,931
Deferred revenue, current
10,493
—
Total current liabilities
21,829
7,331
Deferred revenue, non-current
5,489
—
Other long-term liabilities
1,340
62
Total liabilities
28,658
7,393
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock
—
—
Common stock
4
1
Additional paid-in capital
342,663
132,653
Accumulated other comprehensive income
22
—
Accumulated deficit
(222,807
)
(116,001
)
Total stockholders’ equity
119,882
16,653
Total liabilities and stockholders’
equity
$
148,540
$
24,046
Immunome, Inc.
Consolidated Statements of
Operations
(in thousands, except share
and per share amounts)
Year Ended December
31,
2023
2022
Collaboration revenue
$
14,018
$
—
Operating expenses:
In-process research and development
80,802
—
Research and development
23,089
23,272
General and administrative
19,657
13,629
Total operating expenses
123,548
36,901
Loss from operations
(109,530
)
(36,901
)
Other income:
Interest income, net
2,724
5
Total other income
2,724
5
Net loss
$
(106,806
)
$
(36,896
)
Deemed dividend arising from warrant
modification
—
(622
)
Net loss attributable to common
stockholders
$
(106,806
)
$
(37,518
)
Per share information:
Net loss per common share, basic and
diluted
$
(5.38
)
$
(3.09
)
Weighted-average common shares
outstanding, basic and diluted
19,843,651
12,126,573
Comprehensive loss
Net loss
$
(106,806
)
$
(37,518
)
Unrealized gain on marketable
securities
22
—
Comprehensive loss
$
(106,784
)
$
(37,518
)
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version on businesswire.com: https://www.businesswire.com/news/home/20240328336295/en/
Investor Contact: Max Rosett Interim Chief Financial Officer
investors@immunome.com
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