Full Press Release Details
Reports Full Year 2024 Financial Results and Provides Business Update
Wash. - 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, 2024 and provided a business update.
"Immunome's efficient execution in 2024 laid the foundation
for a productive 2025," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We are pleased with the progress
of our pipeline and, with multiple programs now in clinical development, we expect that our recent financing will support multiple clinical
milestones. We particularly look forward to topline data in the second half of 2025 for the RINGSIDE trial of varegacestat, which we believe
will demonstrate significant benefits for patients with desmoid tumors."
"Our highly capable team is achieving our vision of a broad,
differentiated portfolio of ADCs. We recently dosed the first patient in the Phase 1 clinical trial of IM-1021, our ROR1-targeted ADC.
Three additional novel ADCs, IM-1617, IM-1335 and IM-1340, are in IND-enabling manufacturing, with additional discovery-stage
programs under evaluation. We recently submitted the IND for IM-3050, our FAP radiotherapy, and anticipate initiating a Phase 1 clinical
trial for that program later this year."
Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat 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
the manufacturing and pharmacology work required to support a new drug application filing for varegacestat.
The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The Phase 1 trial is an open-label,
multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid
Immunome recently submitted an IND for IM-3050 and expects to initiate a clinical trial for the program in the second half of 2025.
Pipeline - Immunome's preclinical pipeline also includes three novel ADCs against solid tumor targets, IM-1617, IM-1340
and IM-1335, which are currently undergoing IND-enabling work, and additional, undisclosed ADCs in discovery and lead optimization.
Fourth Quarter and Recent Corporate Highlights
Full-year 2024 Financial
About Immunome, Inc.
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
conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which
is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial;
and IM-3050, a FAP-targeted radioligand, which is the subject of a recently submitted IND. Our pipeline also includes IM-1617, IM-1335,
and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. 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 "expect," "foundation," "look forward," "believe," "vision,"
"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 cash
runway and ability to achieve clinical milestones; Immunome's expectation that it will enroll patients in its Phase 1 clinical trial
for IM-1021 and will report resulting clinical trial data, and that it will initiate a Phase 1 clinical trial for IM-3050; Immunome's
expectations regarding regulatory filings; the ability of Immunome to advance its pipeline; the potential of Immunome's ADC programs
to provide first-in-class or best-in-class status; 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
programs and product 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 advance its pipeline and successfully execute on its business
plan; 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 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.
Chief Financial Officer
Consolidated Balance Sheets
| December 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 143,351 | $ | 98,679 | ||||
| Marketable securities | 73,952 | 39,463 | ||||||
| Prepaid expenses and other current assets | 4,036 | 6,561 | ||||||
| Total current assets | 221,339 | 144,703 | ||||||
| Property and equipment, net | 10,113 | 2,073 | ||||||
| Operating right-of-use assets | 4,278 | 1,564 | ||||||
| Restricted cash | 100 | 100 | ||||||
| Other long-term assets | 4,411 | 100 | ||||||
| Total assets | $ | 240,241 | $ | 148,540 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 14,189 | $ | 3,311 | ||||
| Accrued expenses and other current liabilities | 33,177 | 8,025 | ||||||
| Deferred revenue, current | 6,941 | 10,493 | ||||||
| Total current liabilities | 54,307 | 21,829 | ||||||
| Deferred revenue, non-current | - | 5,489 | ||||||
| Operating lease liabilities, net of current portion | 4,769 | 1,340 | ||||||
| Total liabilities | 59,076 | 28,658 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 6 | 4 | ||||||
| Additional paid-in capital | 696,872 | 342,663 | ||||||
| Accumulated other comprehensive income | 57 | 22 | ||||||
| Accumulated deficit | (515,770 | ) | (222,807 | ) | ||||
| Total stockholders' equity | 181,165 | 119,882 | ||||||
| Total liabilities and stockholders' equity | $ | 240,241 | $ | 148,540 |
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Collaboration revenue | $ | 9,041 | $ | 14,018 | ||||
| Operating expenses: | ||||||||
| In-process research and development | 152,344 | 80,802 | ||||||
| Research and development (1) | 129,542 | 23,089 | ||||||
| General and administrative (1) | 32,955 | 19,657 | ||||||
| Total operating expenses | 314,841 | 123,548 | ||||||
| Loss from operations | (305,800 | ) | (109,530 | ) | ||||
| Interest income | 12,837 | 2,724 | ||||||
| Net loss | $ | (292,963 | ) | $ | (106,806 | ) | ||
| Net loss per share, basic and diluted | $ | (5.00 | ) | $ | (5.38 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 58,639,441 | 19,843,651 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (292,963 | ) | $ | (106,806 | ) | ||
| Unrealized gain on marketable securities | 35 | 22 | ||||||
| Comprehensive loss | $ | (292,928 | ) | $ | (106,784 | ) |
(1) Amounts include non-cash stock based compensation as follows (in thousands):
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Research and development | $ | 5,146 | $ | 1,981 | ||||
| General and administrative | 10,602 | 4,242 | ||||||
| Total share-based compensation expense | $ | 15,748 | $ | 6,223 |