Immuneering Reports Second Quarter 2025 Financial Results and Provides Business Updates
Immuneering (NASDAQ:IMRX) reported Q2 2025 financial results and significant clinical progress for its lead drug atebimetinib. The company highlighted exceptional 94% overall survival at 6 months in first-line pancreatic cancer patients (N=34) treated with atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP), compared to 67% with standard care.
Key developments include a newly granted U.S. composition of matter patent extending exclusivity into 2042, and a notable case of a third-line pancreatic cancer patient maintaining partial response for over 18 months on atebimetinib monotherapy. The company reported Q2 2025 net loss of $14.4 million ($0.40 per share) and cash position of $26.4 million, with runway into 2026.
Immuneering plans to share updated survival data in Q3 2025 and has submitted an End of Phase 2 meeting request to FDA, with pivotal trial initiation expected in 2026.
Immuneering (NASDAQ:IMRX) ha comunicato i risultati finanziari del Q2 2025 e significativi progressi clinici per il suo farmaco di punta atebimetinib. L'azienda ha evidenziato una sopravvivenza globale eccezionale del 94% a 6 mesi nei pazienti con cancro del pancreas in prima linea (N=34) trattati con atebimetinib in combinazione con Gemcitabina/nab‑paclitaxel modificato (mGnP), a fronte del 67% osservato con la terapia standard.
Tra gli sviluppi principali figura la concessione di un brevetto statunitense sulla composizione della sostanza che estende l'esclusività fino al 2042, nonché il caso notevole di un paziente in terza linea che ha mantenuto una risposta parziale per oltre 18 mesi con monoterapia a base di atebimetinib. L'azienda ha riportato una perdita netta nel Q2 2025 di 14,4 milioni di dollari (0,40 dollari per azione) e una posizione di cassa pari a 26,4 milioni di dollari, con liquidità stimata fino al 2026.
Immuneering prevede di condividere dati aggiornati sulla sopravvivenza nel Q3 2025 e ha presentato alla FDA una richiesta di End of Phase 2 meeting; l'avvio dello studio pivotale è atteso nel 2026.
Immuneering (NASDAQ:IMRX) informó los resultados financieros del 2T 2025 y avances clínicos significativos para su fármaco principal atebimetinib. La compañía destacó una supervivencia global excepcional del 94% a los 6 meses en pacientes con cáncer de páncreas de primera línea (N=34) tratados con atebimetinib más Gemcitabina/nab‑paclitaxel modificado (mGnP), frente al 67% con la atención estándar.
Entre los hitos figura la concesión de una patente estadounidense de composición de la materia que extiende la exclusividad hasta 2042, y un caso notable de un paciente en tercera línea que mantiene respuesta parcial por más de 18 meses con monoterapia de atebimetinib. La compañía reportó una pérdida neta en el 2T 2025 de $14.4 millones ($0.40 por acción) y una posición de efectivo de $26.4 millones, con liquidez prevista hasta 2026.
Immuneering planea compartir datos de supervivencia actualizados en el 3T 2025 y ha solicitado a la FDA una reunión End of Phase 2; se espera iniciar el ensayo pivotal en 2026.
Immuneering (NASDAQ:IMRX)는 2025년 2분기 재무실적과 주력 후보 약물 아테비메티닙(atebimetinib)의 주요 임상 진전을 발표했습니다. 회사는 아테비메티닙과 변형 Gemcitabine/nab‑paclitaxel(mGnP)을 병용한 1차 췌장암 환자(N=34)에서 6개월 전체 생존율이 94%로 탁월한 결과를 보였으며, 이는 표준 치료의 67%와 비교된다고 강조했습니다.
주요 성과로는 배타권을 2042년까지 연장하는 미국 물질조성(composition of matter) 특허의 신규 등록과, 3차 치료 환자가 아테비메티닙 단독요법으로 18개월 이상 부분반응을 유지한 주목할 만한 사례가 포함됩니다. 회사는 2025년 2분기 순손실 1,440만 달러 (주당 0.40달러)와 현금 잔고 2,640만 달러를 보고했으며, 자금은 2026년까지 유지될 것으로 보입니다.
Immuneering은 2025년 3분기에 업데이트된 생존 데이터 공개를 계획하고 있으며 FDA에 End of Phase 2 회의 요청을 제출했으며, 피보탈(결정적) 시험 개시는 2026년으로 예상됩니다.
Immuneering (NASDAQ:IMRX) a publié ses résultats financiers du T2 2025 et des progrès cliniques significatifs pour son candidat principal atebimetinib. La société a mis en évidence un taux de survie globale exceptionnel de 94% à 6 mois chez des patients en première ligne atteints d'un cancer du pancréas (N=34) traités par atebimetinib associé à Gemcitabine/nab‑paclitaxel modifié (mGnP), contre 67% avec la prise en charge standard.
Parmi les avancées figurent l'attribution récente d'un brevet américain de composition de matière prolongeant l'exclusivité jusqu'en 2042, ainsi qu'un cas notable d'un patient en troisième ligne maintenant une réponse partielle depuis plus de 18 mois sous monothérapie par atebimetinib. La société a annoncé une perte nette au T2 2025 de 14,4 M$ (0,40$ par action) et une trésorerie de 26,4 M$, avec une visibilité de financement jusqu'en 2026.
Immuneering prévoit de diffuser des données de survie mises à jour au T3 2025, a soumis une demande de réunion End of Phase 2 auprès de la FDA, et prévoit de lancer l'essai pivotal en 2026.
Immuneering (NASDAQ:IMRX) meldete die Finanzergebnisse für Q2 2025 sowie bedeutende klinische Fortschritte für sein Leitprodukt atebimetinib. Das Unternehmen hob eine außergewöhnliche 6‑Monats-Gesamtüberlebensrate von 94% bei Erstlinien-Patienten mit Pankreaskarzinom (N=34) hervor, die mit atebimetinib plus modifiziertem Gemcitabin/nab‑Paclitaxel (mGnP) behandelt wurden, verglichen mit 67% unter Standardtherapie.
Wesentliche Entwicklungen umfassen die Erteilung eines neuen US-Patents zur Wirkstoffzusammensetzung, das die Exklusivität bis 2042 verlängert, sowie einen bemerkenswerten Fall eines Drittlinien-Patienten, der über 18 Monate eine partielle Remission unter Atebimetinib-Monotherapie aufrechterhielt. Das Unternehmen verzeichnete einen Nettoverlust im Q2 2025 von 14,4 Mio. USD (0,40 USD je Aktie) und eine Barposition von 26,4 Mio. USD, mit Finanzierungsreichweite bis 2026.
Immuneering plant, aktualisierte Überlebensdaten im Q3 2025 zu veröffentlichen, hat ein End‑of‑Phase‑2‑Meeting bei der FDA angefragt, und rechnet mit dem Start der pivotalen Studie im Jahr 2026.
- Exceptional 94% overall survival at 6 months in first-line pancreatic cancer trial vs 67% for standard care
- New U.S. composition of matter patent granted, providing exclusivity into 2042
- Third-line pancreatic cancer patient showing 34% tumor reduction and 96% CA 19-9 reduction after 18 months
- Reduced R&D expenses from $10.7M to $10.5M year-over-year
- Net loss increased to $14.4M from $14.1M year-over-year
- Cash position decreased to $26.4M from $36.1M in six months
- Pivotal trial initiation not expected until 2026
Insights
Impressive 94% 6-month survival rate in pancreatic cancer trial shows remarkable potential compared to 67% standard-of-care benchmark.
The 94% overall survival rate at 6 months for first-line pancreatic cancer patients treated with atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) represents a potentially significant advance in a notoriously difficult-to-treat cancer. For context, the standard-of-care GnP regimen achieved only 67% survival at the same timepoint in its pivotal study, with rapid decline to 50% by 8.5 months. This 27 percentage point improvement is particularly noteworthy in pancreatic cancer, where treatment advances have been incremental at best.
The Phase 2a trial data (n=34) showing 72% progression-free survival at 6 months with median OS and PFS not yet reached suggests durability of response. The favorable tolerability profile is equally important, as pancreatic cancer patients often struggle with treatment-related side effects that compromise quality of life.
The case study of a third-line pancreatic cancer patient maintaining a partial response on atebimetinib monotherapy for over 18 months is exceptional. This patient, who progressed through both FOLFIRINOX and Gem/Cis/nab-Pac, demonstrated a 34% reduction in target lesions and 96% reduction in CA 19-9 levels (a tumor marker). The reported weight gain of ~16% suggests the treatment is well-tolerated and potentially improving overall patient health.
The upcoming updated OS and PFS data in Q3 2025 will be critical to validate these early positive signals, particularly whether the survival curve maintains its advantage beyond the 6-month mark. The FDA's feedback on pivotal study plans will shape the company's path to potential approval in this high-unmet-need indication.
Newly granted composition of matter patent extending to 2042 significantly enhances atebimetinib's commercial value and partnership potential.
The USPTO's grant of a composition of matter patent for atebimetinib marks a crucial intellectual property milestone for Immuneering. This patent, expected to provide exclusivity until 2042 with potential for further extension, substantially strengthens the company's market position and commercial prospects.
Composition of matter patents are the strongest form of pharmaceutical IP protection, covering the drug molecule itself rather than just applications or formulations. This patent is particularly significant as it's the first granted in the U.S. for a "deep cyclic inhibitor" - establishing Immuneering as a pioneer in this drug class designed to overcome cancer resistance mechanisms.
The company's disclosure of additional pending patent applications extending potentially to 2044 suggests a comprehensive IP strategy covering compounds, pharmaceutical compositions, and methods of use. This layered approach to patent protection can effectively block competitors and create a formidable barrier to generic entry.
For potential pharmaceutical partners evaluating atebimetinib, this robust patent position significantly enhances the drug's attractiveness for licensing or acquisition, particularly given the promising clinical data in pancreatic cancer. The extended exclusivity period provides ample time for commercial exploitation across multiple potential indications, maximizing the drug's revenue potential before generic competition.
This patent grant comes at a strategic time as Immuneering prepares for pivotal trials and likely partnership discussions, substantially strengthening their negotiating position with both potential partners and investors.
- Company now plans to share updated OS and PFS data from first-line pancreatic cancer patients (N = 34) treated with atebimetinib + mGnP in Q3 2025, earlier than prior guidance -
- Exceptional
- Newly issued U.S. composition of matter patent for atebimetinib expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension -
- Request for End of Phase 2 meeting has been submitted to the FDA;
pivotal trial expected to initiate in 2026 -
CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, today reported financial results for the second quarter ended June 30, 2025, and provided several business updates.
“We are excited to announce updated OS and PFS data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the coming weeks. Last quarter we reported an exceptional
“We are busy preparing for our Phase 3 pivotal trial, and have now submitted our end of phase 2 meeting request to FDA. In addition, the granting of our composition of matter patent for atebimetinib by the United States Patent and Trademark Office (USPTO) was an important milestone for our company. We expect the long patent runway we are forging for atebimetinib will support our efforts to maximize its therapeutic potential across multiple indications,” Zeskind concluded.
Corporate Highlights
- Reported Positive Overall Survival Data for Atebimetinib from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients: In June, Immuneering shared exceptional data from its ongoing Phase 2a trial of atebimetinib in combination with modified mGnP in first-line pancreatic cancer. The company reported that
94% OS and72% PFS were observed at 6 months (n=34; patients treated at the 320 mg once-daily dose of atebimetinib), with median OS and PFS not yet reached. A markedly favorable tolerability profile was also observed. All results were reported using a data cutoff date of May 26, 2025. Subject to regulatory feedback, the company plans to initiate a pivotal trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in 2026. - Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the company was granted a composition of matter patent for atebimetinib by the USPTO, which is expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension. The patent is the first granted in the U.S. for a deep cyclic inhibitor, a once-daily pill that aims to drive longer-lasting benefit by outpacing resistance mechanisms that cause cancer drugs to stop working. Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into 2044.
- Third-Line Pancreatic Cancer Patient Passes 18-month Mark on Atebimetinib Monotherapy: Today, Immuneering is providing an update on a pancreatic cancer patient in the third-line setting who has received atebimetinib monotherapy for more than 18 months as a participant in the company’s Phase 1 trial and who remains on treatment. The patient – who previously experienced disease progression on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on atebimetinib monotherapy at 240 mg once daily and has maintained a partial response, including a
34% reduction in target lesions (RECIST sum of longest diameters) for a confirmed partial response, and a96% reduction in peak CA 19-9 levels. Treatment continued to be well tolerated by the patient, with a ~16% weight gain observed.
Near-Term Milestone Expectations
Immuneering is planning for several near-term milestones related to atebimetinib, including to:
- Announce updated OS and PFS data from first-line pancreatic cancer patients (n = 34) treated with atebimetinib + mGnP in Q3 2025
- Receive regulatory feedback on pivotal study plans in Q4 2025
- Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026
- Initiate additional atebimetinib clinical trial combination arms in 2026
Second Quarter 2025 Financial Highlights
Cash Position: Cash and cash equivalents as of June 30, 2025 were
Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2025 were
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2025 were
Net Loss: Net loss attributable to common stockholders was
2025 Financial Guidance
- Based on cash and cash equivalents as of June 30, 2025, 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 outpacing cancer to help patients outlive their disease. The Company’s lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily deep cyclic inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. 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 atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer; the treatment potential of our pipeline product candidates in other types of cancer; the plans and objectives of Company management for future operations, including with respect to the timing, planning, enrollment and execution of additional atebimetinib combination trials and a potential pivotal trial of atebimetinib in combination with mGnP; the timing for release of additional results from the Phase 2a portion of the atebimetinib trial; the timing and substance of regulatory feedback on pivotal trial plans; expectations regarding our cash runway; the expected expiration of our issued and pending patents and additional planned patent applications, including the U.S. composition of matter patent covering atebimetinib; our ability to obtain patent term extension on our U.S. composition of matter patent; and our expectations for a long patent runway we are forging for atebimetinib will support our efforts to maximize its full therapeutic potential, extending to many different cancer types and combinations.
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 Quarterly Report on Form 10-Q for the three months ended June 30, 2025, 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:
Gina Nugent
Gina.nugent.external@immuneering.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 June 30, | Six Months Ended June 30, | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| Operating expenses | ||||||||||||
| Research and development | $ | 10,454,160 | $ | 10,651,958 | $ | 21,925,852 | $ | 21,854,372 | ||||
| General and administrative | 4,296,417 | 4,254,473 | 8,302,059 | 8,370,493 | ||||||||
| Amortization of intangible asset | 7,317 | 7,317 | 14,633 | 14,633 | ||||||||
| Total operating expenses | 14,757,894 | 14,913,748 | 30,242,544 | 30,239,498 | ||||||||
| Loss from operations | (14,757,894 | ) | (14,913,748 | ) | (30,242,544 | ) | (30,239,498 | ) | ||||
| Other income (expense) | ||||||||||||
| Interest income | 324,013 | 826,104 | 762,532 | 1,630,988 | ||||||||
| Other income, net | - | 7,717 | - | 220,754 | ||||||||
| Net loss | $ | (14,433,881 | ) | $ | (14,079,927 | ) | $ | (29,480,012 | ) | $ | (28,387,756 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.40 | ) | $ | (0.47 | ) | $ | (0.82 | ) | $ | (0.96 | ) |
| Weighted-average common shares outstanding, basic and diluted | 35,985,878 | 29,653,355 | 35,759,026 | 29,511,856 | ||||||||
| Other comprehensive loss: | ||||||||||||
| Unrealized loss from marketable securities | - | 1,084 | - | 778 | ||||||||
| Comprehensive Loss | $ | (14,433,881 | ) | $ | (14,078,843 | ) | $ | (29,480,012 | ) | $ | (28,386,978 | ) |
| IMMUNEERING CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | |||||||
| June 30, 2025 | December 31, 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 26,355,498 | $ | 36,144,720 | |||
| Prepaids and other current assets | 1,369,928 | 3,442,849 | |||||
| Total current assets | 27,725,426 | 39,587,569 | |||||
| Property and equipment, net | 964,138 | 1,122,865 | |||||
| Goodwill | 6,690,431 | 6,690,431 | |||||
| Intangible asset, net | 335,780 | 350,413 | |||||
| Right-of-use assets, net | 3,498,967 | 3,667,352 | |||||
| Other assets | 841,726 | 1,295,783 | |||||
| Total assets | $ | 40,056,468 | $ | 52,714,413 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,395,203 | $ | 1,958,536 | |||
| Accrued expenses | 4,514,960 | 4,973,129 | |||||
| Other liabilities | 209,708 | 233,665 | |||||
| Lease liabilities | 366,959 | 338,438 | |||||
| Total current liabilities | 7,486,830 | 7,503,768 | |||||
| Long-term liabilities: | |||||||
| Lease liabilities, net of current portion | 3,633,601 | 3,824,419 | |||||
| Total liabilities | 11,120,431 | 11,328,187 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Preferred stock, | - | - | |||||
| Class A common stock, | 35,987 | 31,050 | |||||
| Class B common stock, | - | - | |||||
| Additional paid-in capital | 282,675,249 | 265,650,362 | |||||
| Accumulated deficit | (253,775,199 | ) | (224,295,186 | ) | |||
| Total stockholders' equity | 28,936,037 | 41,386,226 | |||||
| Total liabilities and stockholders' equity | $ | 40,056,468 | $ | 52,714,413 | |||
FAQ
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