Immuneering Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
Immuneering (NASDAQ: IMRX) has reported promising results from its Phase 2a trial of IMM-1-104 in pancreatic cancer combinations. The drug showed a 43% objective response rate (ORR) when combined with modified gemcitabine/nab-paclitaxel and 50% ORR with modified FOLFIRINOX, significantly exceeding historical benchmarks of 23% and 32% respectively.
The company highlighted a notable case study of a Phase 1 pancreatic cancer patient maintaining stable disease for over 13 months on IMM-1-104 monotherapy, with a 91% reduction in CA 19-9 levels. Immuneering secured a clinical trial agreement with Regeneron to evaluate IMM-1-104 with Libtayo in non-small cell lung cancer.
Financial results show cash position of $36.1 million as of December 31, 2024, with an additional $13.7 million raised in January 2025. The company reported a net loss of $61.0 million for full year 2024. Cash runway is expected to extend into 2026.
Immuneering (NASDAQ: IMRX) ha riportato risultati promettenti dal suo studio clinico di fase 2a su IMM-1-104 in combinazione con il cancro pancreatico. Il farmaco ha mostrato un 43% di tasso di risposta obiettiva (ORR) quando combinato con gemcitabina/nab-paclitaxel modificati e un 50% di ORR con FOLFIRINOX modificato, superando significativamente i benchmark storici del 23% e del 32% rispettivamente.
L'azienda ha evidenziato un caso studio notevole di un paziente con cancro pancreatico in fase 1 che ha mantenuto una malattia stabile per oltre 13 mesi con monoterapia IMM-1-104, con una riduzione del 91% dei livelli di CA 19-9. Immuneering ha stipulato un accordo per uno studio clinico con Regeneron per valutare IMM-1-104 con Libtayo nel cancro polmonare non a piccole cellule.
I risultati finanziari mostrano una posizione di liquidità di 36,1 milioni di dollari al 31 dicembre 2024, con ulteriori 13,7 milioni di dollari raccolti a gennaio 2025. L'azienda ha riportato una perdita netta di 61,0 milioni di dollari per l'intero anno 2024. Si prevede che il capitale disponibile si estenda fino al 2026.
Immuneering (NASDAQ: IMRX) ha reportado resultados prometedores de su ensayo clínico de fase 2a de IMM-1-104 en combinaciones para el cáncer de páncreas. El fármaco mostró un 43% de tasa de respuesta objetiva (ORR) cuando se combinó con gemcitabina/nab-paclitaxel modificados y un 50% de ORR con FOLFIRINOX modificado, superando significativamente los puntos de referencia históricos del 23% y 32% respectivamente.
La empresa destacó un caso notable de un paciente con cáncer de páncreas en fase 1 que mantuvo una enfermedad estable durante más de 13 meses con monoterapia IMM-1-104, con una reducción del 91% en los niveles de CA 19-9. Immuneering aseguró un acuerdo de ensayo clínico con Regeneron para evaluar IMM-1-104 con Libtayo en cáncer de pulmón no microcítico.
Los resultados financieros muestran una posición de efectivo de 36,1 millones de dólares a partir del 31 de diciembre de 2024, con otros 13,7 millones de dólares recaudados en enero de 2025. La empresa reportó una pérdida neta de 61,0 millones de dólares para el año completo 2024. Se espera que la disponibilidad de efectivo se extienda hasta 2026.
Immuneering (NASDAQ: IMRX)는 췌장암 조합에서 IMM-1-104의 2a상 시험에서 유망한 결과를 보고했습니다. 이 약물은 수정된 젬시타빈/nab-paclitaxel과 결합했을 때 43%의 객관적 반응률 (ORR)을 보였고, 수정된 FOLFIRINOX와 결합했을 때는 50%의 ORR을 기록하여 각각 23% 및 32%의 역사적 기준을 크게 초과했습니다.
회사는 IMM-1-104 단독 요법으로 13개월 이상 안정된 상태를 유지한 1상 췌장암 환자의 주목할 만한 사례 연구를 강조했습니다. 이 환자는 CA 19-9 수치가 91% 감소했습니다. Immuneering은 비소세포 폐암에서 Libtayo와 함께 IMM-1-104를 평가하기 위해 Regeneron과 임상 시험 계약을 체결했습니다.
재무 결과는 2024년 12월 31일 기준으로 3610만 달러의 현금 보유액을 보여주며, 2025년 1월에 추가로 1370만 달러가 모금되었습니다. 회사는 2024년 전체에 대해 6100만 달러의 순손실을 보고했습니다. 현금 소진 기간은 2026년까지 연장될 것으로 예상됩니다.
Immuneering (NASDAQ: IMRX) a rapporté des résultats prometteurs de son essai clinique de phase 2a sur IMM-1-104 dans les combinaisons contre le cancer du pancréas. Le médicament a montré un taux de réponse objective (ORR) de 43% lorsqu'il était combiné avec la gemcitabine/nab-paclitaxel modifiée et un ORR de 50% avec le FOLFIRINOX modifié, dépassant de manière significative les références historiques de 23% et 32% respectivement.
L'entreprise a souligné une étude de cas notable d'un patient atteint d'un cancer du pancréas en phase 1, maintenant une maladie stable pendant plus de 13 mois avec la monothérapie IMM-1-104, avec une réduction de 91% des niveaux de CA 19-9. Immuneering a conclu un accord d'essai clinique avec Regeneron pour évaluer IMM-1-104 avec Libtayo dans le cancer du poumon non à petites cellules.
Les résultats financiers montrent une position de trésorerie de 36,1 millions de dollars au 31 décembre 2024, avec 13,7 millions de dollars supplémentaires levés en janvier 2025. L'entreprise a rapporté une perte nette de 61,0 millions de dollars pour l'année entière 2024. La durée de la trésorerie est prévue jusqu'en 2026.
Immuneering (NASDAQ: IMRX) hat vielversprechende Ergebnisse aus seiner Phase-2a-Studie zu IMM-1-104 in Kombination mit Bauchspeicheldrüsenkrebs berichtet. Das Medikament zeigte eine 43%ige objektive Ansprechrate (ORR), wenn es mit modifiziertem Gemcitabin/nab-Paclitaxel kombiniert wurde, und eine 50%ige ORR mit modifiziertem FOLFIRINOX, was die historischen Benchmarks von 23% und 32% erheblich übertraf.
Das Unternehmen hob eine bemerkenswerte Fallstudie eines Patienten mit Bauchspeicheldrüsenkrebs in Phase 1 hervor, der über 13 Monate mit der Monotherapie IMM-1-104 eine stabile Erkrankung aufrechterhielt, mit einer Reduktion der CA 19-9-Werte um 91%. Immuneering sicherte sich eine klinische Studienvereinbarung mit Regeneron zur Bewertung von IMM-1-104 zusammen mit Libtayo bei nicht-kleinzelligem Lungenkrebs.
Die finanziellen Ergebnisse zeigen eine Liquiditätsposition von 36,1 Millionen Dollar zum 31. Dezember 2024, mit weiteren 13,7 Millionen Dollar, die im Januar 2025 gesammelt wurden. Das Unternehmen meldete einen Nettoverlust von 61,0 Millionen Dollar für das gesamte Jahr 2024. Es wird erwartet, dass die Liquiditätsreserve bis 2026 reicht.
- Strong efficacy data in pancreatic cancer with 43-50% ORR in combination trials
- Promising durability shown with 13+ month stable disease in Phase 1 pancreatic cancer patient
- Multiple FDA designations received (Fast Track and Orphan Drug)
- Strategic partnership with Regeneron for combination trials
- Cash runway extended into 2026 with recent financing
- Increased R&D expenses to $48.0M in 2024 from $41.6M in 2023
- Widening net loss to $61.0M in 2024 from $53.5M in 2023
- Significant cash burn with position decreased to $36.1M from $85.7M year-over-year
Insights
Immuneering's latest data from its Phase 2a trial of IMM-1-104 shows remarkably strong efficacy signals in pancreatic cancer combination therapy. The 43% objective response rate (ORR) with modified gemcitabine/nab-paclitaxel and 50% ORR with modified FOLFIRINOX substantially outperform historical benchmarks of 23% and 32%, respectively. These response rates, coupled with an 86% disease control rate, represent potential breakthrough improvements in a notoriously difficult-to-treat cancer.
The patient case study demonstrating 13+ months of stable disease on IMM-1-104 monotherapy in third-line pancreatic cancer is particularly striking, with 91% reduction in CA 19-9 tumor markers and improved quality of life. The FDA's granting of both Fast Track and Orphan Drug designations further validates the program's potential.
The expansion into multiple combination studies with Regeneron's Libtayo (anti-PD-1), BRAF inhibitors, and G12C inhibitors suggests a comprehensive development strategy targeting multiple RAS-driven cancers. Importantly, the safety profile appears favorable across studies, suggesting IMM-1-104 may offer an improved therapeutic window compared to existing MEK inhibitors, potentially addressing a $2.4 billion market opportunity.
While Immuneering's net loss widened to
The company's strategy pivoting toward pancreatic cancer combinations represents a shrewd focus on a high-unmet-need indication where early data demonstrates substantial improvements over standard-of-care. The dual regulatory designations (Fast Track and Orphan Drug) create potential acceleration pathways that could reduce time and costs to market.
The appointment of Dr. Matushansky as CMO strengthens the executive team at a critical juncture as the company prepares for a potential pivotal trial. With 5 distinct clinical readouts and trial initiations expected in 2025, Immuneering has established multiple catalysts that could drive significant value. The company's ability to combine with both chemotherapy and immunotherapy agents suggests broad application potential across multiple RAS-driven tumor types, substantially expanding the addressable market beyond pancreatic cancer.
- Reported positive data updates from its ongoing Phase 2a trial of lead program IMM-1-104, including encouraging responses in combination with chemotherapy in first-line pancreatic cancer -
- Announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® (cemiplimab) in non-small cell lung cancer -
- Additional IMM-1-104 Phase 2a data updates and initiation of new IMM-1-104 combination arms expected in 2025; planning underway for potential IMM-1-104 global pivotal trial -
- Named industry veteran Dr. Igor Matushansky as Chief Medical Officer -
- Cash runway extended into 2026 -
CAMBRIDGE, Mass., March 20, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business updates.
“We were delighted to report updates from our ongoing Phase 2a trial of IMM-1-104 in January 2025 demonstrating excellent response rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients. Highlights of these data included an observed ORR of
“Importantly, the results demonstrated with IMM-1-104 to date point to its potential combinability, set to continue with our recently announced plans to study IMM-1-104 in combination with a BRAF inhibitor in melanoma, with a G12C inhibitor in non-small cell lung cancer, and with a PD-1 inhibitor in both melanoma and non-small cell lung cancer. We subsequently announced a clinical trial supply agreement with Regeneron for Libtayo in combination with IMM-1-104 in patients with non-small cell lung cancer and aim to get these new trials up and running this year. In support of these plans, we were pleased to announce that Dr. Igor Matushansky has joined Immuneering as Chief Medical Officer to oversee clinical activities, including medical and operational leadership for our development programs."
Zeskind concluded: “As we look ahead to the rest of the year – with our cash balance recently fortified – we expect multiple data events, beginning with an update from our IMM-1-104 Phase 2a trial in the second quarter of 2025. We are continuing to build a growing data set that we believe positions our lead asset with the potential to offer an improved profile in comparison to current MEK inhibitors, which currently represents an existing approximately
Corporate Highlights
- Phase 1 Pancreatic Cancer Patient Passes 13-month Mark on IMM-1-104 Monotherapy: Today, Immuneering provided a case study update for a Phase 1 pancreatic cancer patient in the third-line setting who has been receiving IMM-1-104 monotherapy for over 13 months so far. The patient – who previously progressed on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on IMM-1-104 monotherapy at 240 mg once daily. As of the most recent available scan, the patient has maintained stable disease with a RECIST SLD change of -
24.2% . In addition to a91% reduction in peak CA 19-9 levels, IMM-1-104 has been well tolerated by the patient, who has reported improved quality of life and approximately12% weight gain. - Named Dr. Igor Matushansky as Chief Medical Officer: In March, Immuneering announced that Igor Matushansky, MD, PhD, joined the company as Chief Medical Officer. In this role, Dr. Matushansky will direct Immuneering’s clinical activities, providing medical and operational leadership for the company’s development programs including the ongoing Phase 2a study of IMM-1-104 in pancreatic cancer, lung cancer, and melanoma, and plans to initiate a pivotal Phase 3 clinical trial in pancreatic cancer.
- Announced Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo (cemiplimab): In February, Immuneering announced a clinical trial supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo. The agreement supports the intended evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC).
- Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104: In January, Immuneering announced a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include additional combination arms.
- Launched Pancreatic Cancer Advisory Board: In December, Immuneering announced the formation of its Pancreatic Cancer Advisory Board. The advisory board, which comprises world-renowned oncology clinical researchers, will provide strategic medical and clinical guidance to the company as its pipeline, including lead clinical program IMM-1-104, continues to advance.
- FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma: In December, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors.
- FDA Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer: In October 2024, the FDA granted Orphan Drug designation to IMM-1-104 in the treatment of pancreatic cancer.
Near-Term Milestone Expectations
IMM-1-104
- Further IMM-1-104 Phase 2a data expected in the second quarter of 2025.
- Initiation of Phase 2a arm of IMM-1-104 in combination with Libtayo in NSCLC planned for 2025.
- Initiation of Phase 2a arm of IMM-1-104 in combination with a G12C inhibitor in NSCLC planned for 2025.
- Initiation of Phase 2a arm of IMM-1-104 in combination with a PD-1 inhibitor in melanoma planned for 2025.
- Initiation of Phase 2a arm of IMM-1-104 in combination with a BRAF inhibitor in melanoma planned for 2025.
Fourth Quarter and Full Year 2024 Financial Highlights
- Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2024, were
$36.1 million , compared with$85.7 million as of December 31, 2023. These amounts exclude net proceeds of$13.7 million from the Company’s ATM facility raised in January 2025. - Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were
$14.9 million compared with$11.9 million for the fourth quarter of 2023. Full year 2023 R&D expenses were$48.0 million compared to$41.6 million for full year 2023. The increase in fourth quarter and full year 2024 R&D expenses as compared to the same respective periods of 2023 was primarily attributable to higher clinical costs related to the Company’s lead IMM-1-104 program and increased personnel to support ongoing research and development activities. - General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2024 were
$3.7 million compared with$4.4 million for the fourth quarter of 2023. Full year 2024 G&A expenses were$16.1 million compared to$16.8 million for full year 2023. The decrease in fourth quarter and full year 2024 G&A expenses as compared to the same respective periods of 2023 was primarily due to lower external professional fees and a reduction in employee-related costs, partially offset by higher stock-based compensation related to the general and administrative functions supporting the business. - Net Loss: Net loss attributable to common stockholders was
$18.1 million , or$0.58 per share, for the quarter ended December 31, 2024, compared to$15.1 million , or$0.52 per share, for the quarter ended December 31, 2023. Net loss attributable to common stockholders for full year 2024 was$61.0 million , or$2.04 per share, compared to$53.5 million , or$1.88 per share, for full year 2023.
2025 Financial Guidance
- Based on cash and cash equivalents as of December 31, 2024, plus proceeds from the Company’s subsequent utilization of its ATM facility, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026.
About Immuneering Corporation
Immuneering is a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients. The Company’s lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK designed to improve tolerability and expand indications to include RAS-driven tumors such as most pancreatic cancers. IMM-1-104 is currently in a Phase 1/2a trial in patients with advanced solid tumors including pancreatic cancer. IMM-6-415 is an oral, twice-daily deep cyclic inhibitor of MEK currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS or RAF mutations. The company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of IMM-1-104, alone or in combination with other agents, including chemotherapy, checkpoint inhibitors and BRAF inhibitors; the plans and objectives of Company management for future operations, including with respect to the planning and execution of additional IMM-1-104 combination trials and potential pivotal trial of IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel; the timing for release of additional results from the Phase 2a portion of the trial for IMM-1-104; and expectations regarding our cash runway.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports.
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the annual period ended December 31, 2024, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Media Contact:
Jenna Urban
jurban@cglife.com
Investor Contact:
Laurence Watts
619-916-7620
laurence@newstreetir.com
| IMMUNEERING CORPORATION | |||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||
| (Unaudited) | |||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||
| Operating expenses | |||||||||||
| Research and development | |||||||||||
| General and administrative | 3,693,672 | 4,384,488 | 16,077,746 | 16,759,602 | |||||||
| Amortization of intangible asset | 7,317 | 7,317 | 29,267 | 29,267 | |||||||
| Total operating expenses | 18,558,155 | 16,301,988 | 64,071,401 | 58,412,887 | |||||||
| Loss from operations | (18,558,155 | ) | (16,301,988 | ) | (64,071,401 | ) | (58,412,887 | ) | |||
| Other income (expense) | |||||||||||
| Interest income | 415,240 | 754,144 | 2,593,300 | 3,606,996 | |||||||
| Other income, net | 91,430 | 464,352 | 441,493 | 1,334,269 | |||||||
| Net loss | $(18,051,485 | ) | $(15,083,492 | ) | $(61,036,608 | ) | $(53,471,622 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | ) | ) | ) | ) | |||||||
| Weighted-average common shares outstanding, basic and diluted | 31,050,448 | 29,269,842 | 29,981,565 | 28,416,558 | |||||||
| Other comprehensive income (loss): | |||||||||||
| Unrealized gains from marketable securities | (7,846 | ) | (6,385 | ) | 778 | 29,342 | |||||
| Comprehensive Loss | $(18,059,331 | ) | $(15,089,877 | ) | $(61,035,830 | ) | $(53,442,280 | ) | |||
| IMMUNEERING CORPORATION | |||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
| (Unaudited) | |||||
| December 31, 2024 | December 31, 2023 | ||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | |||||
| Marketable securities | - | 26,259,868 | |||
| Prepaids and other current assets | 3,442,849 | 3,417,984 | |||
| Total current assets | 39,587,569 | 89,083,669 | |||
| Property and equipment, net | 1,122,865 | 1,400,582 | |||
| Goodwill | 6,690,431 | 6,690,431 | |||
| Intangible asset, net | 350,413 | 379,680 | |||
| Right-of-use assets, net | 3,667,352 | 3,995,730 | |||
| Other assets | 1,295,783 | 1,034,446 | |||
| Total assets | |||||
| Liabilities and Stockholders' Equity | |||||
| Current liabilities: | |||||
| Accounts payable | |||||
| Accrued expenses | 4,973,129 | 5,173,960 | |||
| Other liabilities | 233,665 | 259,770 | |||
| Lease liabilities | 338,438 | 300,107 | |||
| Total current liabilities | 7,503,768 | 7,845,503 | |||
| Long-term liabilities: | |||||
| Lease liabilities, net of current portion | 3,824,419 | 4,162,852 | |||
| Total liabilities | 11,328,187 | 12,008,355 | |||
| Commitments and contingencies (Note 10) | |||||
| Stockholders’ equity: | |||||
| Preferred stock, | - | - | |||
| Class A common stock, | 31,050 | 29,272 | |||
| Class B common stock, | - | - | |||
| Additional paid-in capital | 265,650,362 | 253,806,267 | |||
| Accumulated other comprehensive loss | - | (778 | ) | ||
| Accumulated deficit | (224,295,186 | ) | (163,258,578 | ) | |
| Total stockholders' equity | 41,386,226 | 90,576,183 | |||
| Total liabilities and stockholders' equity | |||||
FAQ
What were the response rates for IMM-1-104 combinations in pancreatic cancer trials?
How long is IMRX's cash runway following recent financings?
What key regulatory designations has IMRX's IMM-1-104 received?
What was Immuneering's (IMRX) net loss for full year 2024?
What are the next major catalysts expected for IMRX's IMM-1-104?
