Duyuru • Apr 21
Immuneering Corporation Presents Genetic Data Demonstrating Mechanism to Improve Durability and Survival Supporting Use of Atebimetinib in First-Line Pancreatic Cancer Immuneering Corporation announced the presentation of new genetic data at the 2026 American Association for Cancer Research Annual Meeting taking place April 17-22, 2026 in San Diego, CA. Analysis of circulating tumor DNA from atebimetinib-treated patients shows acquired MAPK pathway alterations are rare, supporting observed durable first-line activity. Atebimetinib-treated tumors rarely acquire the genetic alterations most commonly associated with resistance to RAS inhibitors, providing molecular rationale to treat with atebimetinib early. Inhibitors of RAS, RAF, or MEK often provide only temporary benefit due to pervasive resistance, as tumors acquire new mutations or mechanisms of escape within the MAPK pathway. Atebimetinib, a novel Deep Cyclic Inhibitor of MEK, is engineered to mitigate the selective pressure that typically drives these resistance mechanisms, with the goal of more durable anti-tumor activity. Immuneering presented circulating tumor DNA data from 123 patients treated with atebimetinib, showing that acquired MAPK pathway alterations are rarely seen. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients, while potentially preserving sensitivity to subsequent treatments. Key Findings from the AACR Presentation: Rare MAPK pathway reactivation: Across 86 patients treated with atebimetinib monotherapy and 37 patients treated in combination with chemotherapy, emergent and acquired mutations rarely converged on the RAS/MAPK pathway, in contrast to what is commonly observed with chronic RAS-targeted therapies. Diffuse, non-convergent resistance patterns: Emergent resistance following atebimetinib treatment utilized a variety of non-MAPK pathways, rather than converging on a single escape mechanism. Limited early adaptive resistance: ctDNA analysis showed minimal early molecular evolution during treatment, indicating that atebimetinib is not driving adaptive resistance and may impose less selective pressure than continuous pathway inhibition. Taken together, the data position atebimetinib as a differentiated MEK inhibitor with potential to drive deep and durable antitumor activity. Poster Presentation Details: Title: Atebimetinib’s Deep Cyclic Inhibition of MEK Constrains MAPK-Axis Adaptive and Acquired Alterations in Patients with RAS-Mutant Tumors Session Category: Experimental and Molecular Therapeutics Session Title: Targeting Drug Resistance 2: RAS Signaling Poster Number: 1873 Poster Board Number: 6 Session Date: April 20, 2026 Session Time: 9:00 AM – 12:00 PM ET Location: Poster Section 19. Immuneering has guided to dosing the first patient in its pivotal Phase 3 MAPKeeper 301 trial of atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) in patients with first-line metastatic pancreatic cancer in mid-2026. In the second half of the year, the company expects to dose the first patient in a Phase 2 trial of atebimetinib plus Libtayo in patients with first-line RAS-mutant non-small cell lung cancer. Duyuru • Mar 18
Immuneering Corporation Presents Molecular Data From Atebimetinib-Treated Patients At AACR Annual Meeting Immuneering Corporation announced it will present a poster on one of the three key mechanisms by which atebimetinib aims to improve overall survival: shrinking tumors durably. The poster will be presented at the American Association for Cancer Research Annual Meeting taking place April 17-22, 2026 in San Diego, CA. Inhibitors of RAS, RAF, or MEK often provide only temporary benefit due to resistance, as tumors acquire new mutations or mechanisms of escape within the MAPK pathway. Atebimetinib, a novel Deep Cyclic Inhibitor of MEK, is engineered to mitigate the selective pressure that typically drives these resistance mechanisms, with the goal of more durable anti-tumor activity. Immuneering will present an analysis of circulating tumor DNA (ctDNA) from =64 patients with RAS-mutant solid tumors treated with atebimetinib, showing that acquired MAPK pathway alterations are rarely seen in patients treated with atebimetinib. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients. Title: Atebimetinib’s Deep Cyclic Inhibition of MEK Constrains MAPK-Axis Adaptive and Acquired Alterations in Patients with RAS-Mutant Tumors. Session Category: Experimental and Molecular Therapeutics. Session Title: Targeting Drug Resistance 2: RAS Signaling. Poster Number: 1873. Poster Board Number: 6. Session Date: April 20, 2026. Session Time: 9:00 AM – 12:00 PM ET. Location: Poster Section 19. The abstract will be available on the AACR website. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. The company expects to dose the first patient in mid-2026 in MAPKeeper 301, a globally randomized pivotal Phase 3 trial evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and early-stage programs. Duyuru • Jan 08
Immuneering Corporation Announces Exceptional 64% Overall Survival At 12 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP Immuneering Corporation announced positive updated overall survival (OS) and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with over 13 months median follow up time. 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. The consistently strong separation observed between the overall survival in the clinical trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients and the benchmark for standard of care GnP from the MPACT study has now held at 6 months, 9 months, and 12 months. Having recently reached alignment on the planned pivotal Phase 3 clinical trial design with the FDA and EMA, with overall survival as the primary endpoint, the company plans to dose the first patient in the MAPKeeper 301 pivotal trial in mid-2026, as it moves to bring this new treatment option to patients as expeditiously as possible. Atebimetinib (320mg dosed once-daily) + mGnP demonstrated remarkable OS at 12 months (median follow up of 13.4 months) in first-line pancreatic cancer patients (N=34), with the median OS not yet reached as of the data cutoff date of December 15, 2025. The MPACT pivotal trial for the standard of care benchmark, gemcitabine/nab-paclitaxel, reported significantly lower OS as noted below. 64% OS observed at 12 months; standard of care benchmark reported a 35% OS at 12 months. 83% OS observed at 9 months; standard of care benchmark reported a ~47% OS at 9 months. 94% OS observed at 6 months; standard of care benchmark reported a 67% OS at 6 months. Confirmed Overall Response Rate (ORR) of 39% at 12 months; standard of care benchmark reported an ORR of 23%. Disease Control Rate (DCR) of 81% at 12 months; standard of care benchmark reported a DCR of 48%. Median Progression Free Survival (mPFS) of 8.5 months; standard of care benchmark reported a mPFS of 5.5 months. Unless otherwise specified, all data are reported using a data cutoff date of December 15, 2025, from the same patient cohort (N=34) as previously reported in September 2025. The estimates of (and other references to) standard of care set forth above with respect to the 6- and 12-month follow-up data were reported directly from the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The estimates of (and other references to) standard of care with respect to the nine-month follow-up data were extrapolated and reconstructed by the Company based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The Company’s Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials. The Company believes these compelling updated OS data reflect the potential for a durable, compounding benefit with atebimetinib + mGnP in first-line pancreatic cancer patients. As of the data cutoff date of December 15, 2025, atebimetinib (320mg dosed once-daily) + mGnP continued to demonstrate a favorable tolerability profile in first-line pancreatic cancer patients (N=34), with only two categories of adverse events observed at the Grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy and were previously noted in the September 2025 update). No new safety signals were identified. In the first half of 2026 the company plans to provide an update on an expanded cohort of over 50 first-line pancreatic cancer patients, which includes both the original 34 patients and additional patients previously announced to be enrolled, who are approaching sufficient median follow up time for presentation. The overall survival in the expanded cohort is trending consistently with what has been reported in the original 34 patients. Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including: Second Quarter 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting. 1H 2026: Report updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib + mGnP. Mid-2026: Dose first patient in pivotal Phase 3 clinical trial of atebimetinib in combination with mGnP in first-line pancreatic cancer. 2H 2026: Dose first patient in trial of atebimetinib in combination with Libtayo in non-small cell lung cancer. Duyuru • Dec 18
Immuneering Corporation Advances Towards Dosing First Patient in Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients, Securing Alignment with FDA and EMA Immuneering Corporation announced that it is on track to dose the first patient in its planned global Phase 3 registrational trial in first line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone. Notably, the company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the company's proposed Phase 3 trial. MAPKeeper 301 is designed as a global Phase 3 trial that will evaluate atebimetinib (320 mg QD) in combination With mGnP, compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma. The primary endpoint of the trial is overall survival, and secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements. Immuneering plans to enroll a total of approximately 510 patients in the Phase 3 trial. The company expects to dose the first patient in mid-2026 and share topline results from the trial in mid-2028. Immuneering also reiterated management's belief that the company's current cash and cash equivalents, based on current operating plans, are sufficient to fund operations into 2029. Duyuru • Nov 05
Immuneering Corporation to Report Q3, 2025 Final Results on Nov 12, 2025 Immuneering Corporation announced that they will report Q3, 2025 final results After-Market on Nov 12, 2025 Duyuru • Sep 16
Immuneering Corporation Appoints Thomas Schall as Chairman of the Board Immuneering Corporation announced the appointment of Thomas J. Schall, Ph.D., to Chairman of the Board of Directors. Dr. Schall is a renowned biotech executive and scientist with more than 30 years of leadership in drug discovery and development. He is best known as the founder and longtime CEO and Chairman of ChemoCentryx, where he led the development and eventual FDA approval of Tavneos®, a first-in-class oral therapy for ANCA-associated vasculitis. Under his leadership, ChemoCentryx was acquired by Amgen in 2022 for nearly $4 billion. His career has been defined by bringing paradigm-shifting therapies to patients with high unmet need. Immuneering is set to announce updated data with 9 months median follow up from its ongoing phase 2a study of first-line pancreatic cancer patients treated with atebimetinib + mGnP, on September 25 and at the upcoming Pancreatic Cancer Action Network (PanCAN) Annual Scientific Summit on September 28. Dr. Schall has served on Immuneering’s Board of Directors since March 2024 and brings to the Chairmanship a unique combination of scientific vision, operational discipline, and regulatory acumen. His appointment signals the company’s readiness to enter a new phase of execution as it prepares for pivotal studies, registration filings, and ultimately commercialization. Duyuru • Sep 12
Immuneering to Announce Updated Overall Survival Data from Phase 2a Clinical Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer Patients on September 25, 2025 Immuneering Corporation announced updated overall survival data in first-line pancreatic cancer patients treated with atebimetinib + mGnP (N=34) with 9 months median follow up on September 25, 2025. The Company additionally shared plans for two presentations
at upcoming scientific conferences. Duyuru • Aug 23
Immuneering Corporation announced that it expects to receive $25 million in funding Immuneering Corporation announced that it has entered into a definitive securities purchase agreement with top-tier institutional and other accredited investors to issue 6,329,113 unregistered shares of class A common share at an issue price of 3.95 per share or pre-funded warrants to purchase shares of class A common stock at an issue price of $3.949 per pre-funded warrants for gross proceeds of $25,000,000 on August 21, 2025. The company will also issue accompanying purchase warrants to purchase an aggregate of 2,848,096 shares of class A common stock at an exercise price of $5.50 per share. The pre-funded warrants have an exercise price of $0.001 per share. The purchase warrants will be exercisable for a period of five years following the date on which the class A common stock issued and issuable in the transaction are registered for resale. The closing of the private placement is subject to customary closing conditions and is expected to occur on or about August 26, 2025. Duyuru • Jul 09
Immuneering Corporation Grants U.S. Composition of Matter Patent for Highly Differentiated Cancer Drug Candidate Atebimetinib Immuneering announced that the United States Patent and Trademark Office (USPTO) granted the company a composition of matter patent for atebimetinib (IMM-1-104), an oral once-daily deep cyclic inhibitor of MEK. MEK is a key component of the signaling pathway that drives the majority of cancers, including pancreatic cancer. Atebimetinib previously received FDA Fast Track designations for the treatment of first- and second-line pancreatic ductal adenocarcinoma (PDAC), as well as 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. The FDA also previously granted atebimetinib orphan drug designation for the treatment of pancreatic cancer. Immuneering has also announced plans to study atebimetinib in combination with other therapeutics - in a variety of additional cancers. Duyuru • Jun 19
Immuneering Corporation Announces Interim Data Reveals Promising Results in Pancreatic Cancer Trial On June 17, 2025, Immuneering Corporation (the "Company", "we", "us" and "our") announced interim data from its ongoing Phase 2a clinical trial arm evaluating atebimetinib (formerly known as IMM-1-104), a once-daily oral mitogen-activated protein kinase kinase ("MEK") inhibitor, in combination with modified Gemcitabine/nab-Paclitaxel ("mGnP") in first-line pancreatic cancer patients (the "mGnP Arm"), which is part of Company's ongoing Phase 1/2a clinical trial of atebimetinib in patients with advanced RAS- and/or RAF-mutant solid tumors. The Company announced that, as of a cutoff date of May 26, 2025 (the "Cutoff Date"), of the 36 response evaluable patients in the mGnP Arm dosed at the 240 mg or 320 mg once-daily dose level of atebimetinib in combination with mGnP, one patient achieved a complete response, 13 patients achieved a partial response (with four such patients pending response confirmation at a subsequent scan), 15 patients achieved stable disease, and seven patients showed progressive disease, collectively representing an interim 81% (29/36) disease control rate ("DCR") and an interim 39% (14/36) overall response rate ("ORR"), in each case as measured by the Response Evaluation Criteria in Solid Tumors ("RECIST") method. The Company also announced that, as of the Cutoff Date, 94% overall survival ("OS") and 72% progression free survival ("PFS") were observed in the intent-to-treat population of 34 patients dosed at the 320 mg once-daily dose level of atebimetinib in combination with mGnP (the "320 mg ITT Population"), in each case with a median follow-up time of six months. As of the Cutoff Date, neither the median OS nor the median PFS of the 320 mg ITT Population had been reached. The Company also announced that, as of the Cutoff Date, atebimetinib in combination with mGnP was observed to be generally well tolerated. As of the Cutoff Date, Grade = 3 treatment-emergent adverse events ("TEAEs") observed in 10% or greater of patients in the 320 mg ITT Population were limited to Anemia (six patients or 18%) and Neutropenia (five patients or 15%). No Grade 5 TEAEs were observed in this subset of the patient population. Also on June 17, 2025, the Company announced that additional data from the Phase 2a portion of the Company’s atebimetinib Phase 1/2a trial was expected in the fourth quarter of 2025, and that the Company planned, pending regulatory feedback expected in the fourth quarter of 2025, to initiate a pivotal trial evaluating atebimetinib in combination with mGnP in first-line pancreatic cancer patients in 2026, and to initiate additional clinical trial combination arms evaluating atebimetinib also in 2026. Duyuru • Jun 18
Immuneering Corporation Reports Positive Overall Survival Data for Atebimetinib (IMM-1-104) from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients Immuneering Corporation announced positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients. Building on these new Phase 2a clinical data, Immuneering is planning for several additional milestones related to atebimetinib, including: Regulatory feedback on pivotal study plans in fourth quarter 2025; Data from additional patients in Phase 2a trial in fourth quarter 2025; Initiation of pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreaticcancer in 2026; Initiation of additional atebimetinib clinical trial combination arms in 2026. Duyuru • Apr 22
Immuneering Corporation, Annual General Meeting, Jun 13, 2025 Immuneering Corporation, Annual General Meeting, Jun 13, 2025. Duyuru • Mar 20
Immuneering Names Dr. Igor Matushansky, MD, PhD, as Chief Medical Officer Immuneering announced that Igor Matushansky, MD, PhD, has joined the company as Chief Medical Officer. In this role, he will direct Immuneering’s clinical activities, providing medical and operational leadership for the company’s development programs including an ongoing Phase 2a study of lead program IMM-1-104 in pancreatic cancer, lung cancer, and melanoma, and plans to initiate a pivotal Phase 3 clinical trial in pancreatic cancer. Dr. Matushansky was previously Chief Medical Officer at Sail Biomedicines (a Flagship Pioneering company), where he built and led the clinical/medical, translational, operational, and regulatory functions. Prior to that, he was SVP and Global Head of Oncology Development at Ipsen Pharmaceuticals, where, amongst many programs, he oversaw the completion of NAPOLI-3 leading to the approval of NALIRIFOX for first-line pancreatic cancer. Dr. Matushansky also served as Chief Medical Officer and Global Head of Research and Development at Hookipa Pharma, where he was responsible for bringing novel arenavirus technology from early preclinical to clinical proof-of-concept. He also served as Global Head of Oncology Early Development at Daiichi Sankyo, leading the company’s international research unit focused on early oncology therapeutic programs, and was Global Head at the Gene & Cell Therapy Unit and Global Clinical Program Head within the Oncology Translational Medicine Unit at Novartis. He began his career in academia at the Columbia University Medical Center, where he founded and directed a sarcoma center and ran a laboratory focused on the molecular basis of sarcomas. He earned his BA from Columbia University and his MD and a PhD in molecular biology at Albert Einstein College of Medicine. He performed his internal medicine residency at New York Presbyterian Hospital/Weill Cornell Medical Center and completed a fellowship in medical oncology and a post-doctoral research fellowship in cancer biology at the Memorial Sloan Kettering Cancer Center. Dr. Matushansky continues to dedicate time to taking care of sarcoma patients as an attending physician. Duyuru • Jan 15
Immuneering Corporation Provides Positive Update on Phase 2a Arm Studying IMM-1-104 in Combination with Modified FOLFIRINOX for First-Line Pancreatic Cancer Immuneering Corporation announced a positive update from its Phase 2a arm studying IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer. Data Update from Phase 2a Arm Evaluating IMM-1-104 with Modified FOLFIRINOX in First Line Pancreatic Cancer as of January 6, 2025. Since the Company’s prior update on January 7, 2025 (which used a data cutoff date of December 5, 2024), two new partial responses (PRs) have been reported. As of January 6, 2025, there were six evaluable patients in the Phase 2a arm evaluating IMM-1-104 with modified FOLFIRINOX in first-line pancreatic cancer; three patients achieved partial responses (one unconfirmed) for an overall response rate of 50% (3/6). Four patients remain on treatment. The historic benchmark ORR is 32% for FOLFIRINOX alone. The combination of IMM-1-104 plus modified FOLFIRINOX (mFFX) was observed to be generally well tolerated. The Company is currently evaluating the 320 mg QD dose of IMM-1-104 in combination with modified FOLFIRINOX. 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 arms of IMM-1-104 in combination with a BRAF inhibitor, as well as IMM-1-104 in combination with a checkpoint inhibitor, planned for 2025. Duyuru • Jan 07
Immuneering Announces Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104; Plans to Expand Trial with Additional Arms Immuneering Corporation 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 three additional combination arms. While approved MEK inhibitors mainly benefit a subset of patients with BRAF-driven tumors, IMM-1-104 was designed to improve tolerability and expand indications to include RAS-mutated tumors such as those found in most pancreatic cancers. Updated Data from Phase 2a Arm Evaluating IMM-1-104 with Modified Gemcitabine/nab-Paclitaxel in First Line Pancreatic Cancer as of December 5, 2024: As of December 5, 2024, three patients in the Phase 2a arm evaluating IMM-1-104 with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer achieved complete or partial responses for an overall response rate of 43% (3/7) and disease control rate of 86% (6/7). Four patients remain on treatment. Benchmarks for gemcitabine/nab-paclitaxel alone in first-line pancreatic cancer patients were established by the Phase 3 MPACT study, which included 1 Complete Response (CR) out of 431 patients, a 23% Overall Response Rate, and a 48% Disease Control Rate Benchmarks for modified (m) Gemcitabine/nab-Paclitaxel, the less intensive regimen utilized in the IMM-1-104 Phase 2 combination arm, include an 18.6% ORR. A favorable tolerability profile was observed for IMM-1-104 in combination with modified Gemcitabine/nab-Paclitaxel. Initial Data from Phase 2a Arm Evaluating IMM-1-104 with Modified FOLFIRINOX in First Line Pancreatic Cancer as of December 5, 2024: As of December 5, 2024, all evaluable patients (n=4) experienced target tumor shrinkage and disease control, with one patient achieving a 100% reduction (PR). The combination of IMM-1-104 plus modified FOLFIRINOX (mFFX) was observed to be generally well tolerated. The Company is currently evaluating the 320 mg QD dose of IMM-1-104 in combination with modified FOLFIRINOX. Initial Data from Phase 2a Arm Evaluating IMM-1-104 Monotherapy in Second Line Pancreatic Cancer as of December 5, 2024: As of December 5, 2024, eleven of the twenty-one evaluable patients treated in the Phase 2a arm assessing IMM-1-104 as monotherapy in second-line pancreatic cancer achieved disease control, including one patient with 67% target lesion shrinkage (PR). Nine patients remain on treatment.IMM-1-104 monotherapy was observed to be very well tolerated in second-line pancreatic cancer patients, suggesting that IMM-1-104 may be highly suitable for both monotherapy and combination therapy. Immuneering previously announced that IMM-1-104 received Fast Track designation from the FDA for the treatment of first- and second-line pancreatic cancer, along with orphan drug designation. The FDA also recently 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. Today’s data update follows initial data that was presented in September 2024 on the trial’s arm studying IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer. Immuneering also announced initial pharmacokinetic, pharmacodynamic and safety data from the Phase 1 portion of the company’s Phase 1/2a trial of IMM-6-415. To date, IMM-6-415 has demonstrated its potential to induce Deep Cyclic Inhibition, and in doing so has been well tolerated – consistent with what was observed preclinically for the development candidate. Duyuru • Dec 20
Immuneering Launches Pancreatic Cancer Advisory Board Immuneering Corporation 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. The Company’s Pancreatic Cancer Advisory Board includes the following members: Tanios Bekaii-Saab, M.D., Professor of Medicine, Mayo Clinic; Vincent Chung, M.D., FACP, Professor of Medical Oncology and Therapeutics Research, City of Hope; Shubham Pant, M.D., Professor, GI Medical Oncology, MD Anderson Cancer Center; Jordan Berlin, M.D., FASCO, Professor of Medicine, Director, Division of Hematology and Oncology, Department of Medicine, Vanderbilt-Ingram Cancer Center. Duyuru • Dec 13
Immuneering Corporation Receives FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma Immuneering Corporation announced that the U.S. Food and Drug Administration has granted Fast Track designation for its lead clinical-stage program, 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. IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including melanoma. Fast Track designation is a program designed to facilitate the development and expedite the review of medicines with the potential to treat serious conditions and fulfill an unmet medical need. An investigational medicine that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan and, if relevant criteria are met, may be eligible for accelerated approval and priority review. Duyuru • Sep 13
Immuneering Corporation Announces Positive Initial Phase 2A Data Including Complete and Partial Responses with Imm-1-104 in Combination with Chemotherapy in First-Line Pancreatic Cancer Patients Immuneering Corporation announced positive initial response data from the first five patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line pancreatic cancer as part of its ongoing Phase 2a clinical trial. MAPK pathway variant not detected in plasma cfDNA or prior genomic test. Partial response result classified as "unconfirmed" pending subsequent scan. Benchmarks for gemcitabine/nib-paclitaxel alone in first-line pancreatic cancer patients were established by the Phase 3 MPACT study, which included 1 Complete Response (CR) out of 431 patients, a 23% Overall Response Rate, and a 48% Disease Control Rate. In the Phase 2a portion of Immuneering's ongoing IMM-1-104 Phase 1/2a clinical trial, IMM-1-104 is being evaluated as both monotherapy and in combination with approved chemotherapeutic agents. The Phase 2a portion includes five arms, one of which focuses on patients with RAS mutant melanoma, another on patients with RAS mutant non-small cell lung cancer (NSCLC), and three arms focused on patients with pancreatic cancer. Immuneering previously announced that IMM-1-104 received fast track designation for the treatment of first- and second-line pancreatic cancer. Duyuru • Apr 24
Immuneering Corporation, Annual General Meeting, Jun 12, 2024 Immuneering Corporation, Annual General Meeting, Jun 12, 2024, at 11:00 US Eastern Standard Time. Agenda: To elect Robert J. Carpenter and Benjamin J. Zeskind, Ph.D. as Class III directors to hold office until annual meeting of stockholders to be held in 2027 and until their respective successors have been duly elected and qualified; to ratify the appointment of RSM US LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to transact such other business as may properly come before the Annual Meeting or any continuation, postponement or adjournment thereof. Duyuru • Apr 10
Immuneering Corporation Presents Preclinical Data At the American Association for Cancer Research Annual Meeting Immuneering Corporation presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting, which the company views as supportive of its ongoing Phase 2a clinical trial of IMM-1-104 in RAS-mutated advanced or metastatic solid tumors. Results: IMM-1-104 showed promising combination effects when treated with gemcitabine (GEM), paclitaxel (PAC) or fluorouracil (5FU) in 3D-tumor growth assay (TGA) pancreatic cancer models. IMM-1-104 was synergistic with chemotherapy in animal models of pancreatic cancer. · In a human pancreatic cancer cell line (MIA PaCa-2) tumor xenograft model, IMM-1-104 alone showed greater tumor growth inhibition (TGI) and better durability than any single or combination chemotherapy tested. At day 39, antitumor activity (TGI%) was 103% for IMM-1-104 at 125 mg/kg BID PO, 25.2% for GEM at 60 mg/kg IP Fourth Quarter D, 62.2% for PAC at 10 mg/kg IV Fourth Quarter D, and 36.6% for 5FU at 50 mg/kg IP Fourth Quarter D. In the Phase 2a portion of Immuneering’s ongoing IMM-1-104 Phase 1/2a clinical trial, IMM-1-104 is being evaluated as both monotherapy and in select combinations with approved chemotherapeutic agents. The Phase 2a portion includes five arms, three of which focus on patients with pancreatic cancer. Patients are now on treatment in multiple arms of the ongoing Phase 2a trial, including multiple patients with pancreatic cancer who are being treated with IMM-1-104 in combination with chemotherapy in the first-line setting. The company expects initial data from multiple Phase 2a arms in 2024. Duyuru • Mar 27
Immuneering Announces First Patient Dosed in Its Phase 1/2A Trial of Imm-6-415 to Treat Advanced Solid Tumors with Raf or Ras Mutations Immuneering Corporation announced that the first patient has been dosed in its Phase 1/2a trial of IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations. IMM-6-415 is a Deep Cyclic Inhibitor (DCI) of the MAPK pathway designed with unique drug-like properties including a shorter half-life than IMM-1-104 for an accelerated cadence that will be evaluated as an oral, twice-daily treatment in humans. In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations. During the 2023 AACR-NCI-EORTC conference, Immuneering presented data showing that IMM-6-415 in combination with encorafenib achieved greater tumor growth inhibition and improved durability when compared head-to-head with binimetinib plus encorafenib, in animal models of RAF mutant melanoma and colorectal cancer, consistent with the thesis that DCI can outperform chronic MAPK inhibition. The Phase 1 portion of the Phase 1/2a clinical trial is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMM-6-415 in patients with advanced RAF/RAS mutant solid tumors. The trial will include solid tumor patients with any mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria. The Phase 1 portion of the trial will evaluate IMM-6-415 following a Bayesian mTPI-2 escalation design, which includes a dose escalation phase and dose evaluation phase to establish a candidate recommended phase 2 dose (RP2D), with the RP2D to be evaluated in specific tumor cohorts in the Phase 2a portion of the trial. Recent Insider Transactions • Mar 20
Independent Chair recently bought US$123k worth of stock On the 18th of March, Ann Berman bought around 58k shares on-market at roughly US$2.13 per share. This transaction increased Ann's direct individual holding by 6x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Ann's only on-market trade for the last 12 months. Price Target Changed • Mar 16
Price target decreased by 12% to US$16.86 Down from US$19.25, the current price target is an average from 7 analysts. New target price is 783% above last closing price of US$1.91. Stock is down 76% over the past year. The company is forecast to post a net loss per share of US$1.89 next year compared to a net loss per share of US$1.88 last year. Duyuru • Mar 15
Immuneering Announces Positive Topline Results from Phase 1 Portion of Its Phase 1/2A Clinical Trial of IMM-1-104 in Ras-Mutant Solid Tumors Immuneering Corporation announced positive topline results from the ongoing Phase 1 portion of its Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors. Topline Results from IMM-1-104 Study Phase 1 Portion Safety and Tolerability Results: As of February 20, 2024 (N=41), IMM-1-104 has been well-tolerated, with the potential for a differentiated safety profile. Among treatment-related adverse events (TRAEs) occurring in greater than 10% of patients, no grade 4 TRAEs were observed, only one grade 3 TRAE was observed (a non-serious rash that was reversible), and a modest number of grade 2 TRAEs were observed in each category. No TRAEs were deemed serious. Deep Cyclic Inhibition Proof of Concept for IMM-1-104: As of February 20, 2024 (N=19), patient plasma data showed IMM-1-104 at 320mg inhibiting phosphorylated extracellular signal-regulated kinase (pERK) at a level of 90% or greater for 2.7 hours, before returning to near-zero levels in advance of 24 hours. IMM-1-104 at a 240mg dose achieved 90% or greater levels of pERK inhibition for 1.9 hours, before returning to near-zero levels in advance of 24 hours. Immuneering evaluated both 240mg and 320mg QD as prospective doses for the Phase 2a portion of its Phase 1/2a study. Based on data from this trial, Immuneering selected a candidate RP2D of 320mg QD. Universal-RAS Proof of Concept for IMM-1-104: As of February 20, 2024 (N=22), 100% of evaluable patients profiled by ctDNA and treated with IMM-1-104 experienced no new acquired alterations in RAS. Excluding two patients treated with IMM-1-104 at 160mg (which Immuneering believes to be a sub-therapeutic dose), no new acquired alterations in MAPK pathway genes were observed, suggesting that there was no mutation in the MAPK pathway that a tumor could use to evade IMM-1-104. Initial Signs of Clinical Activity: While clinical activity was not an endpoint of the Phase 1 portion of the trial, Immuneering believes data generated as of the cutoff date of February 20, 2024 show promising signs for IMM-1-104’s potential clinical activity: 53% of patients had = 1 target lesion(s) regress when treated with IMM-1-104 at either 320mg or 240mg. Best individual lesion regressions were -35.7% at 320mg in second-line setting (vs. -11.4% at 240mg). Best RECIST SLD was -18.9% at 320mg in second-line setting (vs. -7.1% at 240mg). Longest duration on therapy was 162 days (5+ months) at 240mg, with no TRAEs. Immuneering plans to present further data from the ongoing Phase 1 portion of its Phase 1/2a study of IMM-1-104 in advanced RAS-mutant solid tumors at a future medical meeting. Immuneering’s Phase 1 portion of its Phase 1/2a clinical trial is an open-label study designed to evaluate the safety, tolerability, PK and preliminary efficacy of IMM-1-104 in patients with advanced RAS mutant solid tumors. The Phase 1 portion is being conducted at five clinical sites in the United States. Data from the Phase 1 portion led to Immuneering’s candidate RP2D of 320mg for IMM-1-104. The Phase 2a portion is expected to include up to twenty clinical sites and has already dosed its first patient. Near-Term Milestone Expectations IMM-1-104 Initial data from multiple arms of the Phase 2a portion of Immuneering’s Phase 1/2a study of IMM-1-104 expected in 2024. IMM-6-415 First patient in Phase 1/2a trial of IMM-6-415 expected to be dosed in March 2024. New Risk • Mar 15
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 7.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$99m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). Board Change • Mar 15
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Diana Hausman was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Duyuru • Mar 12
Immuneering Corporation Appoints Thomas J. Schall to Its Board of Directors Immuneering Corporation announced the appointment of Thomas J. Schall, Ph.D., former Chairman, CEO and Founder of ChemoCentryx before its acquisition by Amgen, to its Board of Directors. Dr. Schall founded ChemoCentryx Inc., a publicly traded biotechnology company with an approved product, and served as its President, Chief Executive Officer and Chairman for 25 years until its acquisition by Amgen for nearly $4 billion in 2022. From 1993 to 1997, Dr. Schall worked at the DNAX Research Institute, a division of Schering-Plough Corporation. Prior to the DNAX Research Institute, he was a scientist with Genentech Inc.Dr. Schall participated in some of the earliest discoveries of chemokine system function and activities, and his laboratories have been responsible for the discovery or co-discovery of a large percentage of all known chemokine receptors. Dr. Schall received his B.S. in biology from Northern Illinois University and his Ph.D. in cancer biology from Stanford University. Duyuru • Mar 11
Immuneering Doses First Patient in Phase 2A Clinical Trial of IMM-1-104 in Ras-Mutant Solid Tumors Immuneering Corporation announced that the first patient has been dosed in the Phase 2a portion of its Phase 1/2a clinical trial of IMM-1-104, its lead program. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of MEK in the MAPK pathway with once-daily oral dosing. The Phase 2a portion of the Phase 1/2a clinical trial of IMM-1-104 is expected to include approximately 150 patients in five arms at our recommended Phase 2 dose of 320 mg once daily. The five arms are as follows: IMM-1-104 monotherapy in patients with pancreatic ductal adenocarcinoma (PDAC) in the first- or second-line setting (n=30). IMM-1-104 monotherapy in patients with RAS-mutant melanoma in the second- or third-line setting post-immunotherapy, or in the first-line setting for patients who are not candidates for existing therapies (n=30). IMM-1-104 monotherapy in patients with RAS-mutant non-small cell lung cancer (NSCLC) in the second- or third-line setting (n=30). IMM-1-104 in combination with mFOLFIRINOX in patients with PDAC in the first-line setting (n=30). IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel in patients with PDAC in the first-line setting (n=30). New Risk • Mar 05
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$100m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Duyuru • Feb 21
Immuneering Corporation Receives FDA Fast Track Designation for IMM-1-104 in Pancreatic Cancer Immuneering Corporation announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its lead clinical-stage program, IMM-1-104, for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing. Fast Track Designation is a program designed to facilitate the development and expedite the review of medicines with the potential to treat serious conditions and fulfill an unmet medical need. An investigational medicine that receives Fast Track Designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, may be eligible for accelerated approval and priority review. New Risk • Dec 02
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Revenue is less than US$1m (US$455 revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$97m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). Reported Earnings • Nov 10
Third quarter 2023 earnings released: US$0.43 loss per share (vs US$0.49 loss in 3Q 2022) Third quarter 2023 results: US$0.43 loss per share (improved from US$0.49 loss in 3Q 2022). Net loss: US$12.6m (loss narrowed 1.9% from 3Q 2022). Revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. New Risk • Oct 31
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 20% per year for the foreseeable future. Revenue is less than US$1m (US$39k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$88m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Duyuru • Oct 13
Immuneering Corporation Presents Preclinical Data Demonstrating Encouraging Anti-Tumor Activity for IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC Conference Immuneering Corporation presented encouraging preclinical data for both IMM-1-104, its lead clinical-stage program, and IMM-6-415 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023 in Boston, Massachusetts. Details for the poster presentations are as follows: Title:Predicting activity of IMM-1-104 as single agent and in combination for patients with RAS or RAF mutant tumors Anti-tumor activity of IMM-1-104 was characterized in 193 tumor models spanning 20 distinct tumor types in the humanized 3D-tumor growth assay (3D-TGA) using cancer-specific, patient-aligned cell lines. IMM-1-104 demonstrated diverse responses across a wide range of MAPK-driven tumor types, including those with RAS or RAF mutations. Pharmacogenomic data were used to generate a model predictive of response to IMM-1-104 and identify biomarker-aligned patient subpopulations. Sensitivity to IMM-1-104 (IC50 < 1uM) tested in 3D-TGA cell lines was highest in melanoma (62.5%) followed by pancreatic cancer (35.0%) and lung cancer (16.7%). IMM-1-104 was tested in combination with gemcitabine or paclitaxel in humanized 3D models of pancreatic cancer, demonstrating enhanced activity and combination therapy potential. IMM-1-104 in combination with encorafenib drove deeper regressions and superior durability of response in a head-to-head in vivo comparison versus binimetinib plus encorafenib. Tumor growth inhibition (TGI) was between 89.8% and 95.2% with the IMM-1-104 plus encorafenib combination and 73.7% with the binimetinib plus encorafenib combination. Title:Deep Cyclic Inhibition of the MAPK pathway with IMM-6-415, alone and in combination with encorafenib, demonstrates anti-tumor activity and tolerability in RAF mutant tumors in vivo Anti-tumor activity of IMM-6-415 was evaluated in more than 60 humanized 3D-TGA models, which included 30 BRAF class I-mutant tumor models. Multiple drug-drug combinations have been explored, including vertical drug combinations with BRAF inhibitors. IMM-6-415, binimetinib and encorafenib were tested head-to-head as single agents and in combination with encorafenib in BRAFV600E melanoma and colorectal subcutaneous tumor xenograft models in female BALB/c nude mice. As monotherapy, IMM-6-415 demonstrated anti-tumor activity in over 50% (34 of 66) of the 3D-TGA models tested, including 30 BRAF mutant preclinical models in which 19 (63%) showed activity. Similar to IMM-1-104, resistant models either lacked an obvious MAPK pathway driver mutation or displayed parallel oncogenic activation events. Sensitive and intermediate responses were also strongly enriched for models harboring an activation mutation in RAS or RAF. Monotherapy treatment with encorafenib or IMM-6-415 displayed superior TGI when compared to binimetinib in the A-375 (melanoma) and HT-29 (colorectal) BRAFV600E tumor models. In combination with encorafenib, IMM-6-415 achieved a greater TGI in vivo than the combination of encorafenib plus binimetinib in BRAFV600E colorectal cancer and melanoma tumor models, suggesting an opportunity for IMM-6-415 as monotherapy or in combination regimens for the treatment of BRAF mutant tumors. Reported Earnings • Aug 04
First half 2023 earnings released: US$0.93 loss per share (vs US$0.93 loss in 1H 2022) First half 2023 results: US$0.93 loss per share (further deteriorated from US$0.93 loss in 1H 2022). Net loss: US$25.8m (loss widened 5.6% from 1H 2022). Revenue is expected to decline by 95% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 16%. Duyuru • Jun 16
Immuneering Corporation Appoints Mallory Morales as Chief Accounting Officer, Effective July 1, 2023 Immuneering Corporation Appointed Mallory Morales as the Company's Chief Accounting Officer and Treasurer, Effective July 1, 2023 (The "Promotion Effective Date"). Ms. Morales Has Served as the Company's Vice President, Finance and Treasurer Since August 2022 And, Prior to That, Served as the Company's Vice President, Finance from May 2021 to August 2022. Ms. Morales Will Continue to Serve as the Company's Principal Financial Officer and Principal Accounting Officer Following the Promotion Effective Date. New Risk • Jun 09
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 19% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Revenue is less than US$1m (US$133k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$95m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). Reported Earnings • May 06
First quarter 2023 earnings released: US$0.51 loss per share (vs US$0.49 loss in 1Q 2022) First quarter 2023 results: US$0.51 loss per share (further deteriorated from US$0.49 loss in 1Q 2022). Net loss: US$13.6m (loss widened 5.5% from 1Q 2022). Revenue is forecast to grow 79% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Price Target Changed • Mar 31
Price target decreased by 12% to US$18.71 Down from US$21.33, the current price target is an average from 7 analysts. New target price is 93% above last closing price of US$9.71. Stock is up 31% over the past year. The company is forecast to post a net loss per share of US$2.17 next year compared to a net loss per share of US$1.91 last year. Major Estimate Revision • Mar 13
Consensus revenue estimates decrease by 80%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$170.0k to US$30.0k. EPS estimate increased from -US$2.55 to -US$2.17 per share. Biotechs industry in the US expected to see average net income decline 32% next year. Consensus price target of US$20.17 unchanged from last update. Share price rose 45% to US$7.53 over the past week. Reported Earnings • Mar 07
Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2022 results: US$1.91 loss per share. Net loss: US$50.5m (loss widened 51% from FY 2021). Revenue missed analyst estimates by 25%. Earnings per share (EPS) exceeded analyst estimates by 4.3%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Price Target Changed • Jan 05
Price target decreased to US$21.33 Down from US$23.33, the current price target is an average from 6 analysts. New target price is 437% above last closing price of US$3.97. Stock is down 72% over the past year. The company is forecast to post a net loss per share of US$2.00 next year compared to a net loss per share of US$2.46 last year. Duyuru • Nov 29
Immuneering Corporation Announces First Patient Dosed in its Phase 1/2a Clinical Trial of IMM-1-104 in Advanced Solid Tumors with RAS Mutations Immuneering Corporation announced that the first patient commenced treatment on November 21 in its Phase 1/2a (NCT05585320) clinical trial of lead asset, IMM-1-104. IMM-1-104 is designed to provide pan-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily dosing. The Phase 1/2a clinical trial is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of IMM-1-104 in patients with advanced RAS mutant solid tumors. The Phase 1 portion of the study, which may enroll up to approximately 42 patients at five clinical sites in the United States, will evaluate IMM-1-104 following a Bayesian mTPI-2 escalation design, which includes a dose escalation phase and dose evaluation phase in order to establish a Recommended Phase 2 Dose (RP2D) candidate. Following the Company’s selection of the RP2D candidate, the Company expects to conduct a Phase 2a dose expansion phase in order to assess the safety and efficacy of IMM-1-104 at the RP2D in RAS mutated pancreatic, melanoma, lung, and colorectal cancers. Major Estimate Revision • Nov 17
Consensus revenue estimates fall by 26% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$590.0k to US$440.0k. Forecast losses increased from -US$1.97 to -US$1.99 per share. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target of US$23.67 unchanged from last update. Share price fell 20% to US$6.88 over the past week. Reported Earnings • Nov 16
Third quarter 2022 earnings: EPS in line with expectations, revenues disappoint Third quarter 2022 results: US$0.49 loss per share (further deteriorated from US$0.47 loss in 3Q 2021). Net loss: US$12.8m (loss widened 51% from 3Q 2021). Revenue is forecast to grow 91% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Duyuru • Oct 21
Immuneering Corporation Appoints Leah R. Neufeld as Chief People Officer Immuneering Corporation announced the appointment of Leah R. Neufeld to the newly created position of Chief People Officer, effective immediately. Ms. Neufeld joins Immuneering from Luzsana Biotechnology, where, since August 2021, she served as Chief Human Resources Officer, and as part of the executive team, helped establish Luzsana globally as a subsidiary of Hengrui Medicines, the larger Pharma company in China. Previously, she was the Vice President, People, at Prevail Therapeutics, from 2019 and following its acquisition by Eli Lilly in 2021. Prior to that, from 2015 through 2019, Ms. Neufeld was the Head of Human Resources at Intercept Pharmaceuticals. Before that, she was the Global Head of Human Resources for NPS Pharma until it was acquired by Shire Pharmaceuticals in 2015. From 2009 to 2014, she held positions of increasing responsibility at Daiichi Sankyo Pharma Development, most recently serving as Director of Human Resources. Earlier in her career, from 2002 to 2009, she held various human resources positions at Johnson & Johnson, including Manager of Human Resources in the consumer division and its oncology company called Ortho Biotech. Ms. Neufeld earned a B.A. in psychology from the American University and an M.S. in career counseling and organization development from Johns Hopkins University. Duyuru • Oct 06
Immuneering To Present Poster on IMM-6-415 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) Immuneering Corporation announced it will present data on its second program IMM-6-415 in a poster presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 8-12, 2022 in Boston or virtually. IMM-6-415 is a third generation dual MEK inhibitor with a differentiated deep cyclic inhibition mechanism that aims to dynamically modulate MAPK pathway signaling. IMM-6-415 was designed with unique drug-like properties that distinguish it from other programs in the Immuneering pipeline. IMM-6-415 is being developed for optimal monotherapy and combination applications in oncology, including the ability to enhance immune mediated therapy in certain settings. Duyuru • Oct 01
Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations Immuneering Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-1-104, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, once daily small molecule, in development for the treatment of advanced RAS mutant solid tumors. The Phase 1/2a clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-cancer activity of IMM-1-104 for the treatment of advanced RAS mutant solid tumors. The study, expected to enroll patients at five internationally recognized clinical sites in the United States, will evaluate IMM-1-104 following a Bayesian mTPI-2 escalation design in order to establish a Recommended Phase 2 Dose (RP2D). Immuneering plans to follow the Phase 1 portion of the study with a dose expansion Phase 2a in RAS mutated pancreatic, melanoma, colorectal, and lung cancers. IMM-1-104 aims to achieve pan-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells. It is designed to be a highly selective third generation MEK inhibitor that modulates the signaling dynamics of the MAPK pathway by driving deep cyclic inhibition that deprives tumor cells of the sustained proliferative signaling required for rapid growth, while providing a cadenced, normalized level of signaling designed to spare healthy cells. IMM-1-104 is being developed to treat advanced solid tumors in patients harboring RAS mutations. Duyuru • Sep 20
Immuneering Corporation Announces Committee Changes Immuneering Corporation announced that effective September 15, 2022, upon the recommendation of the Nominating and Corporate Governance Committee of the Board, the Board appointed Dr. Diana F. Hausman, as a member of the Compensation Committee of the Board and as a member and Chair of the NCG Committee, replacing Mr. Carpenter on the NCG Committee. Major Estimate Revision • Sep 14
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$1.28 to -US$1.97 per share. Revenue forecast of US$641.8k unchanged since last update. Biotechs industry in the US expected to see average net income decline 66% next year. Consensus price target of US$23.33 unchanged from last update. Share price rose 51% to US$12.30 over the past week. Duyuru • Sep 03
Immuneering Announces Submission of IND Application to the FDA for Phase 1/2A Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations Immuneering Corporation announced it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a Phase 1/2a clinical trial of IMM-1-104, an oral once daily small molecule in development for the treatment of advanced RAS mutant solid tumors. In contrast to the narrow approach of targeting specific mutations such as KRAS-G12C, IMM-1-104 is a third generation MEK inhibitor designed for broad pan-RAS activity as well as activity in other MAPK-activated tumors. Based on preclinical data to date, IMM-1-104 has demonstrated robust single-agent anti-tumor activity across a broad range of in vitro and in vivo tumor models driven by MAPK pathway activation events. This includes animal models of KRAS mutant pancreatic cancer, NRAS mutant melanoma, KRAS mutant colorectal cancer, and KRAS mutant lung cancer, regardless of the specific mutation upstream of MEK that drives activation of the MAPK pathway, and all while maintaining a well-tolerated safety profile in such models. "At Immuneering we aim to create medicines for all patients with tumors driven by RAS mutations and other challenging MAPK pathway activation events. In our animal studies, IMM-1-104 strongly inhibited the growth of some of the most aggressive and deadly RAS mutant tumor models out there, without the need to combine with other agents and with good preclinical tolerability. The preclinical data package for IMM-1-104 is uniquely compelling, and we are excited to now evaluate this compound in patients who so urgently need new options." The FDA will review the company's IND application and determine whether the data package is acceptable to predict the safety of IMM-1-104, before clinical trial initiation. In the interim, the company continues to prepare for the planned Phase 1/2a trial evaluating IMM-1-104 for the treatment of advanced solid tumors with RAS mutations. The company is planning to sponsor the recruitment of patients at five internationally recognized clinical sites in the United States. About IMM-1-104 IMM-1-104 aims to achieve pan-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells. It is designed to be a highly selective third generation MEK inhibitor that modulates the signaling dynamics of the MAPK pathway by driving deep cyclic inhibition that deprives tumor cells of the sustained proliferative signaling required for rapid growth, while providing a cadenced, normalized level of signaling designed to spare healthy cells. IMM-1-104 is being developed to treat advanced solid tumors in patients harboring RAS mutations. Major Estimate Revision • Aug 17
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$760.0k to US$640.0k. EPS estimate increased from -US$2.14 to -US$1.28 per share. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target broadly unchanged at US$23.33. Share price rose 6.9% to US$7.12 over the past week. Reported Earnings • Aug 11
Second quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2022 results: US$0.44 loss per share. Net loss: US$11.5m (loss widened 44% from 2Q 2021). Revenue missed analyst estimates by 52%. Earnings per share (EPS) exceeded analyst estimates by 15%. Over the next year, revenue is expected to shrink by 45% compared to a 52% growth forecast for the industry in the US. Duyuru • May 27
Immuneering Reports Data in Two Preclinical Abstracts at the ASCO 2022 Annual Meeting Highlighting Pan-KRAS/NRAS Activity of IMM-1-104 Immuneering Corporation reported data in two preclinical abstracts at the 2022 ASCO Annual Meeting highlighting the pan-KRAS/NRAS activity of IMM-1-104. Head-to-head comparison of the dual-MEK inhibitor IMM-1-104 versus sotorasib or adagrasib in KRAS mutant pancreatic tumors. In this preclinical study, Immuneering researchers tested IMM-1-104 in a head-to-head comparison versus agents including sotorasib and adagrasib, in a series of preclinical models to characterize differential activity of each compound against pancreatic tumors driven by diverse KRAS mutations. Cell-based 2D biochemical and 3D growth assays were performed across nine pancreatic ductal adenocarcinoma (PDAC) models. The Capan-2 PDAC xenograft animal model was used to evaluate single agent activity of IMM-1-104 (75, 100, 150 mg/kg BID p.o. or 150 mg/kg QD p.o.) versus sotorasib or adagrasib (30 and 100 mg/kg QD p.o. each) for 21 days of treatment after tumors had reached volumes of 150 to 200 mm3. The head-to-head comparison in vivo demonstrated a lack of Tumor Growth Inhibition (TGI) by sotorasib and adagrasib in KRAS-G12V mutant Capan-2 PDAC tumors. In contrast, IMM-1-104 observed TGIs of 49-84% across all doses and schedules tested. Consistent with other IMM-1-104 in vivo studies, median body weight loss was no more than 3-5% at top doses. Translational modeling for patients with RAS mutant tumors: Profiling the dual-MEK inhibitor IMM-1-104 in a humanized 3D assay. In this preclinical study, Immuneering researchers characterized IMM-1-104’s pharmacologic activity across 52 tumor cell lines that spanned 11 distinct tumor types in a humanized, Extracellular Matrix (ECM)-based 3D tumor growth assay (3D-TGA). Tumor models were categorized based on in vivo drug PK limits as sensitive to IMM-1-104 (EC50<1uM), intermediate (1uM=EC50=10uM and =25% inhibition at 10uM), or resistant. Models sensitive to IMM-1-104 were enriched for MAPK driver mutations, consistent with pathway addiction. Models with a MAPK driver mutation and compensatory mutations such as PIK3CA or PTEN deletion were more likely to show intermediate response than those with a greater addiction to MAPK drivers. Models lacking a clear MAPK driver mutation but harboring other putative resistance alterations were more likely to be resistant in the 3D-TGA. KRAS mutant pancreatic cancer and NRAS mutant melanoma were the most broadly sensitive patient-aligned models in the 3D-TGA and thus will be included among the target indications for Immuneering’s planned Phase 1/2a clinical trial. Major Estimate Revision • May 17
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$660.0k to US$880.0k. EPS estimate fell from -US$2.05 to -US$2.13 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target down from US$26.80 to US$26.00. Share price rose 3.5% to US$5.06 over the past week. Reported Earnings • May 10
First quarter 2022 earnings: EPS misses analyst expectations First quarter 2022 results: US$0.49 loss per share. Net loss: US$12.9m (loss widened 107% from 1Q 2021). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 8.9%. Over the next year, revenue is expected to shrink by 62% compared to a 48% growth forecast for the industry in the US. Duyuru • May 03
Immuneering Corporation, Annual General Meeting, Jun 21, 2022 Immuneering Corporation, Annual General Meeting, Jun 21, 2022, at 11:00 US Eastern Standard Time. Agenda: To consider to elect Ann E. Berman and Diana F. Hausman, M.D. as Class I directors to hold office until annual meeting of stockholders to be held in 2025 and until their respective successors have been duly elected and qualified; to ratify the appointment of RSM US LLP as independent registered public accounting firm for the fiscal year ending December 31, 2022; and to transact such other business as may properly come before the Annual Meeting or any continuation, postponement or adjournment thereof. Major Estimate Revision • Mar 17
Consensus revenue estimates fall by 75% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$1.94m to US$480.0k. Forecast losses increased from -US$2.01 to -US$2.10 per share. Biotechs industry in the US expected to see average net income decline 42% next year. Consensus price target down from US$31.00 to US$27.25. Share price was steady at US$6.90 over the past week. Reported Earnings • Mar 11
Full year 2021 earnings: EPS and revenues miss analyst expectations Full year 2021 results: US$2.46 loss per share (up from US$3.44 loss in FY 2020). Net loss: US$33.5m (loss widened 97% from FY 2020). Revenue missed analyst estimates by 15%. Earnings per share (EPS) also missed analyst estimates by 30%. Over the next year, revenue is expected to shrink by 6.6% compared to a 61% growth forecast for the pharmaceuticals industry in the US. Duyuru • Jan 07
Immuneering Corporation Reports Preclinical Data on IMM-1-104 in NRAS Mutant Melanoma Model Immuneering Corporation announced preclinical data highlighting the potential of its lead product candidate, IMM-1-104, to inhibit tumor growth in NRAS mutant melanoma models. The data were submitted as a poster presentation at the recently postponed American Association for Cancer Research (AACR) Special Conference: Targeting RAS (originally scheduled for January 7-10, 2022). Given that abstracts are not being published at this time due to postponement of the event, Immuneering is making available the data in a presentation titled “Head-to-Head Comparison of the Dual-MEK Inhibitor IMM-1-104 Versus Binimetinib in NRAS Mutant Melanoma Models,” by Peter King, PhD, Vice President and Head of Discovery at Immuneering on its website (www.immuneering.com/publications/). IMM-1-104 is a novel, allosteric dual-MEK inhibitor that is designed to disrupt phosphorylation of both MEK and its downstream target ERK and has a short plasma drug half-life, with the aim of enabling deep cyclic inhibition with a near-zero drug trough. The Company anticipates submission of an Investigational New Drug application (IND) for IMM-1-104 to the U.S. Food and Drug Administration (FDA) in the third quarter of this year. In this preclinical study, Immuneering modeled binimetinib versus IMM-1-104 in SK-MEL-2 in vivo. SK-MEL-2 is a melanoma tumor cell line that displays a similar molecular profile to approximately half of the patients who participated in the Phase 3 NEMO study, displaying an NRAS-Q61R mutation. The NEMO study results showed binimetinib did not improve overall survival compared with dacarbazine (11.0 vs. 10.1 months, respectively) in NRAS mutant melanoma patients and, in fact, showed a 50% increase in serious adverse events (34% vs. 22%, respectively). Duyuru • Dec 23
Immuneering Corporation (NasdaqGM:IMRX) acquired BioArkive, Inc. from Brett Hall, Praveen Nair, Daniel Flynn, Thomas Barr, Anna Travesa and Dennis Garland for $8.5 million. Immuneering Corporation (NasdaqGM:IMRX) acquired BioArkive, Inc. from Brett Hall, Praveen Nair, Daniel Flynn, Thomas Barr, Anna Travesa and Dennis Garland for $8.5 million on December 22, 2021. As part of the consideration, Immuneering issued 79,635 shares of Class A common stock. BioArkive became a wholly owned subsidiary of Immuneering. In connection with the acquisition, Hall resigned from the Board of Directors of BioArkive. 28 employees of BioArkive became employees of Immuneering as a result of the transaction. Evan Smith of Latham & Watkins LLP acted as legal advisor to Immuneering Corporation.
Immuneering Corporation (NasdaqGM:IMRX) completed the acquisition of BioArkive, Inc. from Brett Hall, Praveen Nair, Daniel Flynn, Thomas Barr, Anna Travesa and Dennis Garland on December 22, 2021. Reported Earnings • Nov 12
Third quarter 2021 earnings released: US$0.47 loss per share Third quarter 2021 results: Net loss: US$8.53m (flat on 3Q 2020). Recent Insider Transactions • Sep 23
Director recently bought US$116k worth of stock On the 20th of September, Peter Feinberg bought around 5k shares on-market at roughly US$24.45 per share. In the last 3 months, they made an even bigger purchase worth US$131k. Insiders have collectively bought US$295k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Sep 17
Director recently bought US$131k worth of stock On the 13th of September, Peter Feinberg bought around 6k shares on-market at roughly US$21.50 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$179k more in shares than they have sold in the last 12 months. Board Change • Jul 31
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Director Ann Berman was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. 
