Core Insights - Amphista Therapeutics has achieved a significant discovery research milestone in its collaboration with Merck, leading to a financial payment for the company [1][2] - The collaboration focuses on the development of novel, non-CRBN/VHL Targeted Glue™ degraders for oncology and immunology applications [1][2] Company Overview - Amphista Therapeutics specializes in next-generation Targeted Protein Degradation (TPD) medicines, aiming to transform the lives of patients with severe diseases such as cancer and neurodegenerative disorders [3] - The company utilizes its proprietary Eclipsys® platform to create unique, bifunctional Targeted Glue™ therapeutics, which offer improved drug-like properties compared to traditional CRBN and VHL-based agents [3] - Amphista was co-founded by Advent Life Sciences and is supported by notable investors including Forbion, Gilde Healthcare, Novartis Venture Fund, SV's Dementia Discovery Fund, and Eli Lilly [3]

Company Strategy & Vision - Kymera is developing oral therapies with biologics-like profiles by combining the "right target" with Targeted Protein Degradation (TPD), aiming to expand patient access globally[12] - The company's vision is to reinvent disease treatment as a fully integrated commercial global biotech, supported by $775 million in cash and equivalents, providing a runway into the first half of 2028[20] - Kymera has delivered 5 new investigational degrader drugs into the clinic since 2020, and is on track to deliver a total of 10 by 2026[17] Immunology Market & TPD - The immunology market is large and underserved, with approximately 160 million total patients across key immunologic diseases[26] - Only ~5 million patients (3%) are on systemic advanced therapies, representing >$100 billion in annual sales for key I/I indications, with 2/3 of these therapies being injectable biologics[27] - Targeted Protein Degradation (TPD) can unlock the undrugged proteome, addressing the 80% of disease-causing proteins currently out of reach for existing technologies[22][23] - In industry surveys, 75% of patients would switch from injectable biologics to oral medications with a similar profile[34] Pipeline Programs & Milestones - **STAT6 (KT-621):** Phase 1 Healthy Volunteer (HV) data is expected in June 2025, with Phase 1b Atopic Dermatitis (AD) patient data anticipated in Q4 2025; Phase 2b trials in AD are expected to start in Q4 2025 and in Asthma in Q1 2026[52][83] - The total potential patient impact for STAT6 (KT-621) is >130 million patients, with only ~1% having access to advanced systemic therapies; the market is projected to reach $23B+ with new indications/entrants[83] - **IRF5 (KT-579):** IND-enabling studies are ongoing, with a Phase 1 trial start expected in early 2026[90][175] - In mouse models of lupus, KT-579, dosed once a day for 63 days, leading to 85% and >90% IRF5 degradation, reduced proteinuria (key disease marker) and prevented disease associated mortality better than all other approved or clinically active agents tested[164]

January 2025 Revolutionizing Immunology: Oral Drugs with Biologics-Like Efficacy Science-driven clinical stage organization with industry-leading oral immunology pipeline J.P. Morgan Healthcare Conference Nello Mainolfi, Ph.D., Founder, President and CEO Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements include, but are not limited to, implied and expr ...

Core Insights - Sanofi has decided to advance Kymera's next-generation oral IRAK4 degrader candidate, KT-485, into clinical testing while not proceeding with KT-474 [1][3] - KT-485 has shown increased selectivity and potency with a favorable safety profile in preclinical testing [1][5] - Kymera is eligible for up to $975 million in collaboration milestones and has achieved a $20 million milestone related to preclinical activities for KT-485 [4][6] Company and Product Development - Kymera Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral small molecule degrader medicines for immunological diseases [2][7] - KT-485, also known as SAR447971, is a first-in-class oral IRAK4 degrader aimed at treating immuno-inflammatory diseases [6] - The collaboration with Sanofi includes a 50/50 development and profit share option for KT-485 in the U.S. [1][4] Clinical and Market Potential - The advancement of KT-485 into Phase 1 testing is expected next year, reflecting its compelling preclinical profile [3][5] - The IRAK4 pathway is targeted due to its role as a master regulator of innate immunity, which could lead to a broad anti-inflammatory effect [6] - The collaboration aims to transform treatment paradigms in immunology by leveraging the unique properties of degraders compared to traditional small molecule inhibitors [5]

KT-621 Phase 1 Healthy Volunteer Trial Results - KT-621 demonstrated >90% STAT6 degradation in blood at doses above 1.5 mg [58, 112] - Complete STAT6 degradation was achieved in both blood and skin at doses ≥5 mg [58, 81, 87, 112] - KT-621 showed a favorable PK profile with rapid absorption (tmax of 2-4 hours) and a mean half-life of 9-36 hours [73] - The Phase 1 trial included 118 healthy volunteers in SAD and MAD groups [65] Th2 Biomarker Impact - KT-621 achieved up to 37% median TARC reduction [98] - KT-621 achieved up to 63% median Eotaxin-3 reduction [104] - IgE levels showed high variability and minimal changes, consistent with dupilumab effects in healthy volunteers [101, 103] Safety and Tolerability - KT-621 was well-tolerated with a safety profile undifferentiated from placebo [58, 107, 112] - No SAEs or severe AEs were reported in the healthy volunteer trial [108] Future Development - The company plans to initiate Phase 2b trials in Atopic Dermatitis (AD) and Asthma, starting in Q4 2025 and Q1 2026, respectively [21, 50] - The company has $775 million in cash and expects the runway to last into the first half of 2028 [16]

Core Insights - Kymera Therapeutics announced positive Phase 1 results for KT-621, a once-daily oral STAT6 degrader, which exceeded expectations and demonstrated a robust safety profile [1][2][3] Study Results - KT-621 achieved over 90% mean STAT6 degradation in blood at all doses above 1.5 mg, with complete degradation in both blood and skin at doses ≥50 mg [1][3][9] - The drug demonstrated a median TARC reduction of up to 37% and a median Eotaxin-3 reduction of up to 63%, indicating its potential effectiveness compared to dupilumab [1][11] - The safety profile of KT-621 was comparable to placebo, with no serious adverse events reported and no clinically relevant changes in vital signs or lab tests [1][12] Study Design - The Phase 1 trial was a double-blind, placebo-controlled study involving 118 healthy volunteers, assessing the safety and tolerability of escalating doses of KT-621 [4][5] - Single ascending doses ranged from 6.25 to 800 mg, while multiple ascending doses were administered daily for 14 days at levels from 1.5 to 200 mg [5][6] Pharmacokinetics and Pharmacodynamics - KT-621 exhibited rapid absorption with a median time to maximum concentration (tmax) of 2-4 hours and a mean half-life of 9-36 hours [6] - The drug demonstrated deep and prolonged STAT6 degradation in blood and skin, with steady-state achieved by Day 4 [6][9][10] Next Steps - The ongoing BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) patients is expected to report data in Q4 2025 [1][13] - Two parallel Phase 2b trials in AD and asthma are planned to commence in Q4 2025 and Q1 2026, respectively [1][13] Company Overview - Kymera Therapeutics is focused on developing oral small molecule degrader medicines for immunological diseases, aiming to provide treatments with the convenience of oral administration and the efficacy of injectable biologics [1][16][17]

Core Insights - Kymera Therapeutics, Inc. will announce results from the Phase 1 clinical trial of KT-621 on June 2, 2025, during a video webcast [1] - KT-621 is a first-in-class oral degrader targeting STAT6, which is involved in Th2 inflammation, potentially offering a new treatment option for over 130 million patients globally suffering from various Th2 diseases [3][4] - The company is advancing KT-621 through multiple clinical trials, including a Phase 1b trial in atopic dermatitis and upcoming Phase 2b trials in asthma and moderate to severe atopic dermatitis [4] Company Overview - Kymera Therapeutics is a clinical-stage biotechnology company focused on targeted protein degradation (TPD) to develop innovative therapies for critical health issues [5] - The company aims to create a pipeline of oral small molecule degraders that provide effective and convenient treatment options for patients [5] - Founded in 2016, Kymera has been recognized as one of Boston's top workplaces [5]

Core Insights - Kymera Therapeutics announced promising preclinical data for KT-621, an oral STAT6 degrader, showing comparable or superior efficacy to dupilumab in chronic asthma models [1][3] - The company has completed a Phase 1 trial for KT-621 and plans to report data in June 2025, with ongoing trials for atopic dermatitis and upcoming Phase 2b trials for asthma and atopic dermatitis [4][1] Group 1: KT-621 Development - KT-621 is the first STAT6 targeted medicine to enter clinical development, demonstrating potential as a once-daily oral treatment for asthma and other Th2 allergic diseases [1][6] - Preclinical data indicate that KT-621 can prevent disease progression and reverse established disease in asthma models, outperforming dupilumab in certain metrics [3][1] - The company plans to initiate two parallel Phase 2b trials in atopic dermatitis and asthma in late 2025 and early 2026, respectively [4][1] Group 2: Clinical Trials and Data - The Phase 1 healthy volunteer trial for KT-621 has been completed, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics [4][1] - Data from the ongoing KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis patients is expected in the fourth quarter of 2025 [4][1] - A webcast is scheduled for June 2025 to disclose comprehensive data from the Phase 1 trials, including safety and biomarker results [4][1] Group 3: Company Vision and Market Potential - Kymera Therapeutics aims to expand patient access to oral systemic therapies for immuno-inflammatory diseases, addressing a significant unmet need in the market [3][6] - The company emphasizes the convenience of KT-621 as an oral medication, which could reach broader patient populations compared to injectable biologics [6][3] - KT-621 has the potential to transform treatment paradigms for over 130 million patients globally suffering from Th2 diseases [6][1]

Core Insights - Kymera Therapeutics has introduced KT-579, a novel oral degrader targeting IRF5, aimed at treating rheumatic and autoimmune diseases, potentially offering a best-in-class oral drug option [1][2][3] - The program is positioned to address multiple immuno-inflammatory diseases with limited oral treatment options, enhancing the company's oral immunology pipeline [1][2] - KT-579 has shown superior efficacy in preclinical models compared to existing therapies, with plans to initiate Phase 1 clinical testing in early 2026 [1][3][4] Company Overview - Kymera Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral small molecule degrader medicines for immunological diseases [1][7] - The company aims to pioneer targeted protein degradation (TPD) to create effective therapies for conditions that are difficult to treat with conventional methods [7] Product Details - KT-579 is a highly selective and potent oral degrader of IRF5, demonstrating significant activity in preclinical studies, including robust degradation in vivo and a favorable safety profile [4][5] - The drug has shown efficacy in reducing proteinuria and autoantibodies in lupus models, as well as significant reductions in joint swelling in RA models [5] Upcoming Events - Kymera will host a video webcast on May 9, 2025, to discuss the first quarter 2025 results and share preclinical data on KT-579 [1][6]

Core Insights - BeyondSpring Inc. reported significant clinical progress and strategic advancements in 2024, particularly for its lead asset Plinabulin and its partnership with SEED Therapeutics [2][3] Clinical Developments - Plinabulin showed a statistically significant survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild-type), a market lacking new therapies for over a decade [3][5] - Ongoing Phase 2 studies indicate Plinabulin's potential to resensitize tumors that have progressed on PD-1/PD-L1 inhibitors, demonstrating promising efficacy and good tolerability [3][9] - SEED Therapeutics secured a strategic collaboration with Eisai Co., Ltd., which could yield up to $1.5 billion in potential payments, enhancing its oncology pipeline [3][10] Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $16.7 million, a decrease from $21.9 million in 2023, indicating improved financial performance [19] - Research and development expenses were $2.6 million in 2024, down from $7.3 million in 2023, reflecting cost optimization measures [10] - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments totaling $2.9 million, with current assets amounting to $25.3 million [10][16] Strategic Collaborations - SEED Therapeutics is advancing its lead oncology asset, RBM39 degrader, which received Rare Pediatric Disease and Orphan Drug Designations from the FDA, reinforcing its potential in targeted protein degradation [3][10] - The collaboration with Eisai and the existing partnership with Eli Lilly are expected to drive significant advancements in oncology and targeted protein degradation [3][10] Future Milestones - Key upcoming milestones include updated data from ongoing Phase 2 studies in metastatic NSCLC and extensive-stage small-cell lung cancer (ES-SCLC) expected in 2025 [10][19] - The expected IND filing for the RBM39 degrader is anticipated in mid-2025, with patient enrollment beginning in the second half of 2025 [10]