Core Insights - The article does not provide any specific insights or analysis related to a company or industry, focusing instead on the author's qualifications and disclosures [1][2][3]. Group 1 - The author holds multiple degrees in Electronics and Telecommunication Engineering, Computer Science, Business Management, and Computer Applications [1]. - The author collaborates with another professional but emphasizes independent analysis [1]. - There are no stock or derivative positions held by the author in any mentioned companies, nor plans to initiate such positions [2].

Company Overview - AIM ImmunoTech Inc. is a member of the Medical sector, which includes 931 individual stocks and currently holds a Zacks Sector Rank of 9 [2] - AIM ImmunoTech Inc. belongs to the Medical - Drugs industry, which consists of 141 individual stocks and is currently ranked 96 in the Zacks Industry Rank [5] Performance Analysis - AIM ImmunoTech Inc. has gained about 7.1% year-to-date, which matches the average return of Medical companies [4] - The Zacks Consensus Estimate for AIM's full-year earnings has increased by 3.8% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [4] - In comparison, Cullinan Therapeutics, another Medical stock, has outperformed the sector with a year-to-date increase of 19.2% [4] Industry Comparison - The Medical - Drugs industry, to which AIM belongs, has seen an average gain of 3.5% this year, indicating that AIM is performing better than its industry peers [5] - Cullinan Therapeutics is part of the Medical - Biomedical and Genetics industry, which has moved up by 22.9% so far this year, and is currently ranked 94 [6]

Financial Overview - As of December 31, 2025, Cullinan Therapeutics reported unaudited cash, cash equivalents, short- and long-term investments, and interest receivable totaling $439.0 million, expected to provide runway into 2029[6]. - The company emphasizes that preliminary financial data is subject to change and has not been audited[7]. Clinical Trials and Studies - The Phase 1 OUTRACE study for rheumatoid arthritis and systemic lupus erythematosus is ongoing, with no dose-limiting toxicities observed in completed cohorts[12]. - Initial clinical data from the Phase 1 study of velinotamig in autoimmune diseases is expected to be shared in Q4 2026[12]. - Initial data from the OUTRACE study in Sjögren's disease is expected to be shared in Q4 2026[12]. - The company anticipates sharing initial data on safety and biomarker activity from the OUTRACE study in Q2 2026[12]. - CLN-049 received Fast Track designation for relapsed/refractory acute myeloid leukemia (AML) and plans to share updates from the dose escalation study in the second half of 2026[18]. - The company plans to initiate monotherapy dose expansion cohorts for relapsed/refractory AML in Q2 2026 and complete enrollment for pivotal trials in Q4 2026[18]. Product Development and Approvals - Zipalertinib's NDA submission for accelerated approval is expected to be completed in Q1 2026, with potential milestone payments of up to $130.0 million[15]. - The company is co-developing zipalertinib with Taiho Pharmaceutical, sharing 50% of future pre-tax profits from U.S. sales[15].

Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose for CLN-049 pivotal registrational study and initiate combination study in frontline AML in Q4 2026 Zipalertinib rolling NDA submission expected to be complete in Q1 2026 and full enrollment of REZILIENT3 frontline study expected in H1 2026 Preliminary cash and investments of $439.0 million as o ...

Core Insights - The presentation focuses on the initial results of CLN-049, which were presented at the ASH event, highlighting its potential for patients with Acute Myeloid Leukemia (AML) [1] Company Pipeline Strategy - The company outlines its broad pipeline strategy, indicating a structured approach to drug development and future projects [4] - The Chief Medical Officer will recap the results of CLN-049 and discuss immediate next steps for its development [4] Key Personnel Involvement - Dr. Jeff Jones, the Chief Medical Officer, and Dr. David Sallman from the Moffitt Cancer Center are key figures in the presentation, with Dr. Sallman being a leading investigator in the study and a prominent researcher in p53-mutated AML and MDS [3]

Summary of Cullinan Therapeutics Update / Briefing Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS: CGEM) - **Focus**: Development of T-cell engagers for oncology and autoimmune diseases, particularly in acute myeloid leukemia (AML) Key Points from the Call Industry Context - **AML Treatment Landscape**: There is a significant unmet need for effective treatments, especially for patients with TP53 mutated AML, which has a poor prognosis [2][24] - **Current Market**: Approximately 22,000 new AML cases are diagnosed annually in the U.S., with a large portion relapsing after initial therapy, representing a market opportunity exceeding $1 billion [45][46] Pipeline and Product Development - **CLN-049**: A FLT3-directed T-cell engager showing promise in treating AML, particularly in patients with TP53 mutations [8][9] - **Clinical Trials**: - Initial data from a dose escalation study indicated a composite complete response (CR) rate of 31% at the highest dose of 12 micrograms per kilogram [18][21] - The study enrolled 45 patients, with 41 providing efficacy data, showing a favorable safety profile with manageable cytokine release syndrome (CRS) [12][15] - Fast-track designation from the FDA was secured for CLN-049, emphasizing its potential in treating relapse refractory AML [6][21] Clinical Efficacy and Safety - **Efficacy Data**: - Among patients treated at doses above 6 micrograms, 8 out of 32 showed a response, with 5 achieving CR at the highest dose [18][19] - Durable responses were noted, with some patients remaining in remission beyond 16 weeks [19][21] - **Safety Profile**: - CRS was the most common adverse event, occurring in just over one-third of patients, with most cases being grade one or two [15][16] - The safety profile is favorable compared to existing T-cell engagers in other hematologic malignancies [15][16] Future Development Plans - **Expansion Studies**: Plans to initiate expansion studies in Q1 2026, targeting both all-comer AML patients and those with TP53 mutations [20][47] - **Regulatory Pathway**: A clear development strategy is in place for both relapse refractory and frontline settings, with plans for a pivotal single-arm study for accelerated approval [46][47] Commercial Opportunity - **Market Potential**: The broad applicability of CLN-049 to AML patients without the need for biomarker testing positions it uniquely in the market, potentially disrupting current treatment paradigms [45][46] - **Financial Outlook**: The opportunity in the relapse refractory segment alone is estimated to exceed $1 billion, with expansion into frontline settings opening up multi-billion-dollar potential [46][48] Additional Insights - **TP53 Mutations**: A significant focus on patients with TP53 mutations, which represent a challenging subset of AML, with a median survival of only six months in frontline settings [33][34] - **Research and Development**: The company is leveraging its internal expertise in hematology to expedite the development of CLN-049, aiming to address the urgent need for effective therapies in AML [46][48] This summary encapsulates the critical insights from the Cullinan Therapeutics update, highlighting the company's strategic focus on CLN-049 and its potential impact on the treatment landscape for AML.

© Cullinan Therapeutics, Inc. All rights reserved. Confidential and proprietary. | 2 Agenda Introduction & Pipeline Strategy Nadim Ahmed CLN-049 Update at ASH December 8, 2025 Important notice and disclaimers This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including express or implied statements regarding the Company's beliefs and expectat ...

Group 1 - U.S. stocks experienced a decline, with the Dow Jones falling over 200 points on Monday [1] - Paramount Skydance Corporation launched an all-cash tender offer to acquire Warner Bros. Discovery, Inc. for $30 per share, valuing the company at $108.4 billion [1] - Paramount aims to create a scaled Hollywood leader by merging with Warner Bros. [1] Group 2 - Paramount Skydance shares increased by 9.8% to $14.68 on Monday [2] - Other notable stocks that gained include Wave Life Sciences Ltd., which rose 129.1% to $17.16 after positive interim Phase 1 data for its obesity drug [4] - Structure Therapeutics Inc. saw a gain of 100.5% to $69.30 following the announcement of topline data from its clinical program for obesity treatment [4] Group 3 - Fulcrum Therapeutics, Inc. shares rose 62.3% to $14.44 after reporting initial results from its Phase 1b trial for sickle cell disease [4] - Kymera Therapeutics, Inc. gained 51.2% to $100.75 after reporting successful trial results for its KT-621 drug [4] - Confluent, Inc. shares increased by 29.2% to $29.89 after IBM agreed to acquire the company for $31 per share [4]

Core Insights - CLN-049 monotherapy shows promising efficacy in patients with relapsed/refractory acute myeloid leukemia (R/R AML), achieving a 31% complete response (CR) rate at the highest tested dose of 12 µg/kg [1][5][12] - The drug has received Fast Track designation from the U.S. FDA, indicating its potential to address unmet medical needs in AML treatment [1][12] - An in-person event will be held by the company to discuss the clinical data presented at the 67th American Society of Hematology Annual Meeting [1][8] Efficacy Results - As of August 2025, 45 patients were enrolled in the Phase 1 study, with 41 patients being evaluable for efficacy [3] - The CR/CRh rate at the highest dose of 12 µg/kg was 31%, with anti-leukemic activity observed at doses ≥6 µg/kg [5][6] - Among patients achieving a CR/CRh response at doses ≥6 µg/kg, 63% had a duration of response exceeding 16 weeks [4][6] Safety Profile - The safety profile of CLN-049 is favorable, with the most common treatment-emergent adverse events being cytokine release syndrome (35.6%) and infusion-related reactions (33.3%) [13] - Most adverse events were Grade 1 or 2, with no Grade 3 cytokine release syndrome observed [13] Target Population - CLN-049 targets FLT3-expressing leukemia cells, applicable to both mutated and non-mutated forms, making it relevant for a broad population of AML patients [10][13] - The drug shows particular promise for patients with TP53-mutated AML, with a 50% CR/CRh response rate observed in this subgroup at the highest dose [13] Future Development - The development of CLN-049 will continue under FDA Fast Track designation, with ongoing dose escalation and planned expansion cohorts in early 2026 [7][12]

Core Insights - The FDA has granted Fast Track designation to CLN-049 for treating relapsed/refractory acute myeloid leukemia (AML), highlighting the urgent need for new treatment options in this area [1][2] - Initial results from the Phase 1 study of CLN-049 indicate meaningful efficacy, including complete responses, suggesting its potential as a novel immunotherapeutic approach for AML [2][4] - CLN-049 is a bispecific T cell engager designed to target FLT3-expressing leukemia cells, making it applicable to a broad population of AML patients regardless of FLT3 mutational status [4][5] Company Overview - Cullinan Therapeutics, Inc. is focused on developing first- or best-in-class therapies for autoimmune diseases and cancer, leveraging expertise in T cell engagers [8] - The company is advancing its clinical-stage pipeline with a rigorous scientific approach aimed at delivering new standards of care for patients [8] Industry Context - Acute myeloid leukemia (AML) is the most common form of acute leukemia in adults, with approximately 22,000 new diagnoses annually in the U.S. and around 11,000 deaths [6] - Despite recent advances, the five-year survival rate for patients with relapsed or refractory AML is 10% or less, indicating a significant unmet medical need for effective therapies [7] - Currently, there are no approved immunotherapies for AML, underscoring the critical demand for innovative treatment options [7]