Regeneron Corporate Presentation J A N U A R Y 2 0 2 6 2 Integrating Genetics, Proteomics, and Big Data World's largest DNA and proteomics-linked healthcare database, enabling advanced drug discovery, development, and healthcare analytics This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially. Note regarding forward-looking statements and non-GAAP financial measures This presentation includes forward-looking statements that i ...

Core Insights - BioVaxys Technology Corp. announced positive findings from a Phase 2 clinical study of maveropepimut-S (MVP-S) in combination with pembrolizumab and low-dose cyclophosphamide for advanced or metastatic bladder cancer, reinforcing the potential of MVP-S to enhance checkpoint inhibitor activity across multiple solid tumor indications [1][4] Group 1: Clinical Study Findings - The Phase 2 study assessed the safety, tolerability, and clinical activity of the combination regimen in patients with metastatic bladder cancer, including those who had progressed on prior anti-PD1/PD-L1 therapies [2] - Key findings indicate that combining MVP-S with checkpoint inhibitors can expand antigen-specific T cell responses, reduce regulatory T-cell activity, and amplify anti-tumor activity [2] - Of 17 evaluable subjects, five showed objective responses, including 2 confirmed complete responses (CRs) and 3 partial responses (PRs), with notable responses in patients previously resistant to checkpoint inhibitors [5] Group 2: MVP-S Mechanism and Composition - MVP-S is a DPX-based immunotherapy that includes multiple survivin-derived peptides, a T-helper peptide, and an innate immune stimulant, promoting efficient antigen uptake and robust T-cell activation [3] - The DPX platform employs a novel, non-aqueous, lipid-in-oil formulation that mimics natural immune processes, resulting in durable immune responses without systemic release at the injection site [3] Group 3: Market Context and Future Opportunities - The encouraging results from the Phase 2 study support advancing MVP-S toward Phase 3 development in ovarian cancer and exploring broader partnering opportunities across additional indications [4] - Major anti-PD1 therapies, such as Merck's Keytruda and Bristol Myers Squibb's Opdivo, are approaching significant patent expirations by 2028, creating opportunities for MVP-S in a competitive market [4] - BioVaxys continues to advance its oncology pipeline, with MVP-S demonstrating consistent tolerability and immune activation across various cancer indications [6]

Core Insights - Immuneering Corporation's stock declined after the release of updated data from its Phase 2a trial of atebimetinib combined with modified chemotherapy for first-line pancreatic cancer [1] Clinical Trial Results - The trial involved 34 patients with a median follow-up of over 13 months, showing an overall survival rate of 35% at 12 months for the chemotherapy regimen, compared to 64% for the atebimetinib combination [1] - At 9 months, survival was reported at 83% for the atebimetinib arm versus approximately 47% for the chemotherapy arm, and at 6 months, the rates were 94% for atebimetinib compared to 67% for chemotherapy [2] - Median progression-free survival (PFS) was 8.5 months for atebimetinib compared to 5.5 months for chemotherapy, with a confirmed overall response rate (ORR) of 39% at 12 months versus 23% for the chemotherapy group [2] Safety Profile - The combination of atebimetinib (320mg once daily) and mGnP demonstrated a favorable tolerability profile, with two categories of Grade 3 adverse events occurring in more than 10% of patients [3] Future Developments - Data from an expanded cohort of 50 pancreatic cancer patients in the atebimetinib + mGnP trial is anticipated in the first half of 2026 [4] - The company plans to initiate dosing for the pivotal Phase 3 trial (MAPKeeper 301) of atebimetinib + mGnP in mid-2026 [4] - Immuneering also expects to begin dosing the first patient in a trial combining atebimetinib with Regeneron Pharmaceuticals' Libtayo in non-small cell lung cancer in the second half of 2026 [5] - As of December 2025, the company confirmed that its cash and cash equivalents are sufficient to fund operations into 2029 [5] Stock Performance - Immuneering's shares fell by 26.53% to $6.12 during premarket trading following the announcement of the trial data [6]

Core Insights - The European Commission has approved the label expansion of Regeneron Pharmaceuticals' PD-1 inhibitor Libtayo for use as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][9]. Group 1: Libtayo Approval and Efficacy - The recent approval expands Libtayo's indications to include patients at high risk of disease recurrence, complementing its existing approvals for advanced CSCC, advanced basal cell carcinoma, advanced non-small cell lung cancer, and recurrent or metastatic cervical cancer [2][9]. - The approval is based on data from the global late-stage C-POST study, which demonstrated a 68% reduction in the risk of disease recurrence or death when Libtayo was compared to placebo [3][5]. - CSCC is one of the fastest-growing forms of skin cancer, and the approval highlights the need for earlier intervention in patients who are at significant risk of recurrence despite effective management through surgery or radiation [4][5]. Group 2: Financial Performance and Market Position - Libtayo has shown strong sales performance, totaling $1.03 billion in the first nine months of 2025, reflecting a 21% year-over-year increase [5]. - Regeneron is also evaluating Libtayo for use as a monotherapy and in combination with other therapies for various solid tumors and blood cancers [6]. Group 3: Eylea Developments - The FDA has approved Eylea HD for the treatment of macular edema following retinal vein occlusion, allowing for dosing up to every eight weeks after an initial monthly period [7][9]. - Eylea remains a significant contributor to Regeneron's revenue, although it faces competition from Roche's Vabysmo, which has impacted Eylea's sales [10][11]. - Eylea HD sales in the U.S. increased by 10% in Q3 2025 due to higher demand, and further label expansions are expected to boost sales [10]. Group 4: Portfolio Diversification and New Approvals - Regeneron is actively working to diversify its portfolio in response to declining Eylea sales, with a year-to-date stock performance of -1.4% compared to the industry's growth of 16.5% [12]. - Recent FDA approvals for linvoseltamab-gcpt and Ordspono have strengthened Regeneron's oncology franchise, targeting relapsed or refractory multiple myeloma and certain types of lymphoma, respectively [14][15].

Core Insights - The European Commission has approved Libtayo (cemiplimab) as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation, marking a significant advancement in treatment options for earlier-stage patients [1][2][4] - The approval is based on the results of the Phase 3 C-POST trial, which demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo, with a hazard ratio of 0.32 [1][2][6] Company Overview - Regeneron Pharmaceuticals, Inc. is a leading biotechnology company focused on developing innovative treatments for serious diseases, including various cancers [27][28] - The company has a strong pipeline, with nearly half of its investigational assets in oncology, including Libtayo, which serves as a backbone for many investigational combinations [9][27] Clinical Trial Details - The C-POST trial was a randomized, placebo-controlled, double-blind study involving 415 patients at high risk of CSCC recurrence, who had completed surgery and postoperative radiation therapy [6][7] - Participants received either Libtayo or placebo for up to 48 weeks, with specific dosing regimens outlined [7] Treatment Implications - Libtayo is currently the standard of care for advanced CSCC in Europe, and its approval for earlier-stage patients could significantly alter treatment paradigms [1][4] - The incidence of non-melanoma skin cancer (NMSC), including CSCC, is expected to increase by 40% in the EU over the coming decades, highlighting the need for effective treatments [4] Safety Profile - The safety profile of Libtayo in the adjuvant setting is consistent with its known profile in advanced cancers, with grade ≥3 adverse events occurring in 24% of patients receiving Libtayo [3] - Common adverse events included fatigue, pruritus, rash, and diarrhea, with treatment discontinuation due to adverse events occurring in 10% of Libtayo patients [3]

Core Insights - Sensei Biotherapeutics announced results from the dose expansion portion of its Phase 1/2 trial for solnerstotug, a monoclonal antibody targeting VISTA, at the ESMO Congress 2025 [1][2] Study Design and Patient Population - The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo, enrolling 44 patients with "hot" tumor types and 20 patients with "cold" tumor types [2] - Among the "hot tumor" patients, 41 had previously received PD-(L)1 therapy and progressed, indicating a challenging prognosis for these patients [3][4] Efficacy Results - In the higher 15 mg/kg dose cohort, the overall 6-month progression-free survival (PFS) rate was 50% among PD-(L)1 resistant patients, which is significantly higher than historical benchmarks [6][7] - Six clinical responses were observed at the 15 mg/kg dose, including five in patients with PD-(L)1 resistant tumors, while no responses were noted at the 3 mg/kg dose [5][6] Safety Profile - Solnerstotug was well tolerated, with only six mild (Grade 1) cytokine release syndrome (CRS) events reported, all manageable [8][9] - The safety profile remains consistent with prior data and compares favorably to other checkpoint inhibitor combinations [8] Future Development Plans - Sensei plans to initiate two Phase 2 studies in 2026, subject to FDA feedback and capital raising, focusing on NSCLC and Merkel Cell Carcinoma [11][12] - The first trial will be a randomized study comparing solnerstotug plus a PD-(L)1 inhibitor against chemotherapy in patients who failed anti-PD-(L)1 treatment [11] - The second trial will be a single-arm study in PD-(L)1 resistant Merkel Cell Carcinoma patients, with potential for accelerated approval [12] Unique Mechanism of Action - The combination of solnerstotug and cemiplimab may demonstrate a unique pattern of delayed, durable responses, indicating a complementary mechanism to PD-(L)1 therapies [10][9]

Core Opinion - Regeneron Pharmaceuticals received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for Libtayo as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][2] Clinical Trial Results - The Phase 3 C-POST trial demonstrated that Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo, with a hazard ratio of 0.32 and a p-value of less than 0.0001 [1][2] - In the trial, locoregional or distant recurrence rates were lower in the Libtayo group (4% vs. 17% for locoregional and 5% vs. 13% for distant recurrence) compared to placebo [2] Safety Profile - The safety profile of Libtayo in this trial was consistent with its known safety profile in advanced cancers, with adverse events occurring in 91% of patients receiving Libtayo and 89% in the placebo group [3] - Grade ≥3 adverse events were reported in 24% of the Libtayo group compared to 14% in the placebo group, with hypertension being the only grade ≥3 adverse event occurring in more than 2% of patients in the Libtayo arm [3] Trial Design - The C-POST trial was a randomized, placebo-controlled, double-blind, multicenter global study involving 415 patients at high risk of CSCC recurrence [4][5] - Participants received either Libtayo or placebo for up to 48 weeks, with specific dosing regimens outlined [5] About CSCC - Cutaneous squamous cell carcinoma (CSCC) is a common type of non-melanoma skin cancer, with a projected 40% increase in incidence in the EU by 2040 [6] Regeneron's Commitment to Cancer Treatment - Regeneron aims to develop transformative medicines for cancer, leveraging scientific innovation and a deep understanding of biology and genetics [7][8] - The company has a robust pipeline focused on various solid tumors and blood cancers, with Libtayo being a key asset [8][27]

Core Insights - Regeneron Pharmaceuticals announced new data from the Phase 3 C-POST trial for Libtayo (cemiplimab), focusing on a patient-centric every 6-week dosing regimen for high-risk cutaneous squamous cell carcinoma (CSCC) [1][2] Group 1: Clinical Data and Trial Results - The C-POST trial data will be presented at the ESMO 2025 Meeting, highlighting the efficacy and safety of Libtayo as an adjuvant treatment for CSCC [1][2] - Patients in the trial initially received 350 mg of Libtayo every 3 weeks for 12 weeks, with most switching to every 6-week dosing thereafter, while the safety profile remained consistent with previous findings [2] Group 2: Regulatory and Approval Status - The new data supports the FDA approval of Libtayo as the first immunotherapy for adjuvant treatment of adult patients with high-risk CSCC following surgery and radiation [2] Group 3: Company Overview and Pipeline - Regeneron is focused on developing therapies for over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [6][26] - Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint, approved in over 30 countries for various indications, including advanced CSCC and non-small cell lung cancer [8][9]

Core Insights - Immuneering Corporation (IMRX) has entered into a clinical supply agreement with Eli Lilly (LLY) for the KRAS G12C inhibitor, olomorasib (LY3537982) [1] - The agreement supports a planned phase II study evaluating Immuneering's atebimetinib (IMM-1-104) in combination with olomorasib for treating advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC) [2] - Immuneering's shares rose by 21.7% following the announcement, and the stock has increased by 170.5% year-to-date compared to the industry's 4.1% rise [2][3] Agreement Details - The combination of atebimetinib and olomorasib is expected to provide a vertical blockade of the RAS-MAPK pathway, with preclinical data showing enhanced tumor regression and prolonged survival compared to monotherapy [5] - This is Immuneering's second collaboration announcement in 2025, following a similar agreement with Regeneron Pharmaceuticals to evaluate atebimetinib with Libtayo for advanced NSCLC [6][7] - In both agreements, Immuneering retains full worldwide development and commercialization rights to atebimetinib [8] Ongoing Studies - Immuneering is advancing atebimetinib in other cancer studies, including a phase IIa study in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer [9] - Preliminary data from this study indicated a 94% overall survival and 72% progression-free survival at six months, with updated data expected later in Q3 2025 [10] - The company plans to initiate a pivotal study for atebimetinib in combination with modified gemcitabine/nab-paclitaxel in 2026, pending regulatory feedback [11]

Core Insights - Sensei Biotherapeutics, Inc. announced the presentation of clinical data from the Phase 1/2 trial of solnerstotug, both alone and in combination with Libtayo, at the ESMO Congress 2025 in Berlin [1] Company Overview - Sensei Biotherapeutics is a clinical stage biotechnology company focused on developing next-generation therapeutics for cancer patients [2] - The company utilizes its TMAb™ platform to create conditionally active therapeutics that target immunosuppressive signals in the tumor microenvironment [2] - Solnerstotug is the lead product candidate, designed to block the VISTA checkpoint selectively in low pH tumor environments, enhancing T cell activation [2]