Immunome Reports Full Year 2024 Financial Results and Provides Business Update
Immunome (NASDAQ: IMNM) announced its full year 2024 financial results and business updates. The company expects topline data from the Phase 3 RINGSIDE study of varegacestat for desmoid tumors in H2 2025. Key developments include the first patient dosing in Phase 1 trial of IM-1021 (ROR1-targeted ADC) and IND submission for IM-3050 (FAP-targeted radioligand therapy).
Financial highlights: Cash position of $217.3 million as of December 31, 2024, plus additional $172.5 million from January 2025 financing. The company reported R&D expenses of $129.5M, in-process R&D expenses of $152.3M, and G&A expenses of $33.0M for 2024. Net loss was $293.0M. Cash runway extends into 2027.
Pipeline progress includes three novel ADCs (IM-1617, IM-1340, IM-1335) in IND-enabling manufacturing and completion of RINGSIDE Part B enrollment in February 2024.
Immunome (NASDAQ: IMNM) ha annunciato i risultati finanziari e gli aggiornamenti aziendali per l'intero anno 2024. L'azienda si aspetta dati preliminari dallo studio di Fase 3 RINGSIDE su varegacestat per i tumori desmoidi nel secondo semestre del 2025. Tra i principali sviluppi, c'è stata la somministrazione del primo paziente nel trial di Fase 1 di IM-1021 (ADC mirato a ROR1) e la presentazione della domanda IND per IM-3050 (terapia radioligand mirata a FAP).
Risultati finanziari: Posizione di cassa di $217,3 milioni al 31 dicembre 2024, più ulteriori $172,5 milioni dal finanziamento di gennaio 2025. L'azienda ha riportato spese per R&S di $129,5 milioni, spese per R&S in corso di $152,3 milioni e spese generali e amministrative di $33,0 milioni per il 2024. La perdita netta è stata di $293,0 milioni. La disponibilità di cassa si estende fino al 2027.
I progressi della pipeline includono tre nuovi ADC (IM-1617, IM-1340, IM-1335) in fase di produzione abilitante IND e il completamento dell'arruolamento della Parte B di RINGSIDE a febbraio 2024.
Immunome (NASDAQ: IMNM) anunció sus resultados financieros y actualizaciones comerciales para el año completo 2024. La compañía espera datos preliminares del estudio de Fase 3 RINGSIDE de varegacestat para tumores desmoides en la segunda mitad de 2025. Los desarrollos clave incluyen la dosificación del primer paciente en el ensayo de Fase 1 de IM-1021 (ADC dirigido a ROR1) y la presentación de la solicitud IND para IM-3050 (terapia radioligand dirigida a FAP).
Aspectos financieros: Posición de efectivo de $217.3 millones al 31 de diciembre de 2024, más $172.5 millones adicionales del financiamiento de enero de 2025. La compañía reportó gastos de I+D de $129.5 millones, gastos de I+D en proceso de $152.3 millones y gastos generales y administrativos de $33.0 millones para 2024. La pérdida neta fue de $293.0 millones. La duración del efectivo se extiende hasta 2027.
El progreso de la pipeline incluye tres nuevos ADC (IM-1617, IM-1340, IM-1335) en fabricación habilitante IND y la finalización de la inscripción de la Parte B de RINGSIDE en febrero de 2024.
Immunome (NASDAQ: IMNM)는 2024년 전체 재무 결과 및 사업 업데이트를 발표했습니다. 이 회사는 2025년 하반기에 desmoid 종양에 대한 varegacestat의 3상 RINGSIDE 연구에서 주요 데이터를 기대하고 있습니다. 주요 발전 사항으로는 IM-1021 (ROR1 표적 ADC)의 1상 시험에서 첫 환자 투여와 IM-3050 (FAP 표적 방사성 리간드 요법)에 대한 IND 제출이 포함됩니다.
재무 하이라이트: 2024년 12월 31일 기준 현금 보유액은 $217.3 백만이며, 2025년 1월 자금 조달로 추가 $172.5 백만이 있습니다. 이 회사는 2024년 연구 및 개발 비용으로 $129.5M, 진행 중인 연구 및 개발 비용으로 $152.3M, 일반 및 관리 비용으로 $33.0M을 보고했습니다. 순손실은 $293.0M이었습니다. 현금 운영 기간은 2027년까지 연장됩니다.
파이프라인 진행 상황에는 IND 승인 제조 중인 세 가지 새로운 ADC (IM-1617, IM-1340, IM-1335)와 2024년 2월 RINGSIDE Part B 등록 완료가 포함됩니다.
Immunome (NASDAQ: IMNM) a annoncé ses résultats financiers et ses mises à jour commerciales pour l'année entière 2024. La société s'attend à des données préliminaires de l'étude de phase 3 RINGSIDE sur le varegacestat pour les tumeurs desmoïdes au second semestre 2025. Les développements clés incluent la première administration chez un patient dans l'essai de phase 1 d'IM-1021 (ADC ciblé ROR1) et la soumission de l'IND pour IM-3050 (thérapie radioligand ciblée FAP).
Points financiers : Position de trésorerie de $217,3 millions au 31 décembre 2024, plus $172,5 millions supplémentaires provenant du financement de janvier 2025. La société a déclaré des dépenses de R&D de 129,5 millions de dollars, des dépenses de R&D en cours de 152,3 millions de dollars et des dépenses générales et administratives de 33,0 millions de dollars pour 2024. La perte nette s'élevait à 293,0 millions de dollars. La durée de trésorerie s'étend jusqu'en 2027.
Les progrès de la pipeline incluent trois nouveaux ADC (IM-1617, IM-1340, IM-1335) en fabrication habilitante IND et l'achèvement de l'inscription de la partie B de RINGSIDE en février 2024.
Immunome (NASDAQ: IMNM) hat seine finanziellen Ergebnisse und Geschäftsupdates für das gesamte Jahr 2024 bekannt gegeben. Das Unternehmen erwartet im zweiten Halbjahr 2025 erste Daten aus der Phase-3-Studie RINGSIDE zu varegacestat bei desmoiden Tumoren. Zu den wichtigsten Entwicklungen gehört die Dosisverabreichung an den ersten Patienten in der Phase-1-Studie von IM-1021 (ROR1-zielgerichtetes ADC) sowie die Einreichung des IND für IM-3050 (FAP-zielgerichtete Radioligandtherapie).
Finanzielle Höhepunkte: Bargeldposition von $217,3 Millionen zum 31. Dezember 2024, plus zusätzliche $172,5 Millionen aus der Finanzierung im Januar 2025. Das Unternehmen berichtete von F&E-Ausgaben in Höhe von 129,5 Millionen US-Dollar, laufenden F&E-Ausgaben von 152,3 Millionen US-Dollar und allgemeinen und Verwaltungskosten von 33,0 Millionen US-Dollar für 2024. Der Nettoverlust betrug 293,0 Millionen US-Dollar. Die Liquidität reicht bis 2027.
Fortschritte in der Pipeline umfassen drei neuartige ADCs (IM-1617, IM-1340, IM-1335) in der IND-fähigen Produktion und den Abschluss der Rekrutierung für Teil B der RINGSIDE-Studie im Februar 2024.
- Completed upsized public offering raising $172.5M in January 2025
- Strong cash position of $389.8M with runway extending into 2027
- Phase 3 RINGSIDE trial fully enrolled, topline data expected H2 2025
- Advanced pipeline with first patient dosed in IM-1021 Phase 1 trial
- Three additional ADCs advancing to IND-enabling studies
- Significant net loss of $293.0M in 2024
- High R&D expenses of $129.5M in 2024
- Substantial in-process R&D expenses of $152.3M
Insights
Immunome's financial results reveal a $293 million net loss for 2024, reflecting its pre-commercial status and significant R&D investments. The company reported $217.3 million in cash equivalents as of December 31, 2024, which doesn't include the $172.5 million from January's public offering. Combined, these resources extend the company's projected runway into 2027, providing substantial operational flexibility through multiple clinical milestones.
The $129.5 million R&D expense and $152.3 million in-process R&D expense demonstrate aggressive investment in both internal development and business development activities. This dual-pronged approach has built a diversified oncology pipeline with multiple shots on goal, reducing the company's dependence on any single program.
Most importantly, the extended cash runway provides Immunome sufficient capital to reach the pivotal Phase 3 RINGSIDE readout expected in H2 2025, a potential value inflection point. The company's strategy of simultaneously advancing multiple ADC candidates and a radioligand therapy program represents efficient capital deployment across several potentially valuable therapeutic modalities in oncology.
For investors, this financial profile reflects a typical development-stage biotech with significant cash burn justified by multiple clinical programs. The company appears well-capitalized for its current development plans, though substantial additional capital will eventually be required for potential commercialization activities.
Immunome is executing a strategically diversified oncology pipeline with multiple modalities targeting difficult-to-treat cancers. The Phase 3 RINGSIDE study of varegacestat for desmoid tumors represents their most advanced program, with full enrollment achieved in February 2024 and topline data expected in H2 2025. Desmoid tumors, while rare, represent an area of significant unmet need with treatment options.
The company's antibody-drug conjugate (ADC) platform appears particularly promising, with IM-1021 (ROR1-targeted) now in Phase 1 testing for B-cell lymphomas and advanced solid tumors. ROR1 is an intriguing oncology target with expression across multiple tumor types but minimal expression in normal adult tissues, potentially offering a favorable therapeutic window.
The IND submission for IM-3050, a FAP-targeted radioligand therapy, represents entry into another cutting-edge therapeutic modality. FAP (fibroblast activation protein) is highly expressed in cancer-associated fibroblasts across multiple tumor types, making it a compelling target for delivering radiation precisely to tumor microenvironments.
The company's three additional novel ADCs in IND-enabling studies (IM-1617, IM-1340, IM-1335) suggest a robust preclinical pipeline leveraging their proprietary HC74 TOP1 inhibitor payload. The breadth of this pipeline provides multiple opportunities for clinical success while diversifying risk across programs and modalities. The upcoming RINGSIDE data will be particularly important as the company's first potential pivotal dataset.
- Topline data for Phase 3 RINGSIDE study of varegacestat in progressing desmoid tumors expected in second half of 2025.
- First patient dosed in Phase 1 clinical trial evaluating IM-1021, a ROR1-targeted ADC.
- IND submitted in March 2025 for IM-3050, a FAP-targeted radioligand therapy.
- Projected cash runway extends into 2027
“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.”
Pipeline Highlights
Varegacestat: 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.
IM-1021: 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 tumors.
IM-3050: Immunome recently submitted an IND for IM-3050 and expects to initiate a clinical trial for the program in the second half of 2025.
Preclinical 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
-
Successfully completed an upsized underwritten public offering for gross proceeds of
$172.5 million - Nominated IM-1617, IM-1340 and IM-1335 as novel ADC candidates, with IND-enabling work initiated in late 2024.
- Presented data highlighting preclinical efficacy for IM-1021 and a differentiated profile for HC74, Immunome’s proprietary TOP1 ADC payload, at the 36th ORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in October 2024.
Full-year 2024 Financial Results
-
As of December 31, 2024, cash, cash equivalents and marketable securities totaled
$217.3 million $172.5 million -
Research and development expenses for the year ended December 31, 2024 were
$129.5 million $5.1 million -
In-process research and development expenses for the year ended December 31, 2024 were
$152.3 million -
General and administrative expenses for the year ended December 31, 2024 were
$33.0 million $10.6 million -
Immunome reported a net loss of
$293.0 million
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 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.
| IMMUNOME, INC. | ||||||||
| Consolidated Balance Sheets | ||||||||
| (In thousands) | ||||||||
| 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 |
|
||
| IMMUNOME, INC. | ||||||||
| 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 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20250319932146/en/
Investor Contact:
Max Rosett
Chief Financial Officer
investors@immunome.com
Source: Immunome, Inc.
FAQ
When will Immunome (IMNM) report topline data for the Phase 3 RINGSIDE trial of varegacestat?
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