Data from the KT-621 BROADEN2 Phase 2b AD patient trial expected to be reported by mid-2027 KT-621 BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 Completed dosing in KT-621 BroADen Phase 1b AD trial with data to be reported in December 2025 WATERTOWN, Mass., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that it rec ...

Core Insights - Kymera Therapeutics has made significant progress in its clinical trials, particularly with KT-621, which is the first STAT6-directed agent for atopic dermatitis (AD) patients, with data expected in December 2025 [1][2][3] - The company is well-capitalized with $979 million in cash as of September 30, 2025, providing a runway into the second half of 2028 [1][14] - Upcoming milestones include the initiation of the KT-621 BROADEN2 Phase 2b trial in AD and the BREADTH Phase 2b trial in asthma, both expected to accelerate development across multiple indications [2][9] Clinical Development Updates - Enrollment and dosing have been completed in the KT-621 BroADen Phase 1b trial for moderate to severe AD, with results anticipated in December 2025 [1][3] - The KT-621 BROADEN2 Phase 2b trial has been initiated, evaluating three doses in approximately 200 patients over 16 weeks, with data expected by mid-2027 [3][4] - KT-579, an oral degrader of IRF5, has completed IND-enabling studies, with a Phase 1 clinical trial expected to start in early 2026 [1][10] Financial Performance - Collaboration revenues for Q3 2025 were $2.8 million, down from $3.7 million in Q3 2024, primarily from the collaboration with Gilead Sciences [11] - Research and development expenses increased to $74.1 million in Q3 2025 from $60.4 million in Q3 2024, driven by investments in the STAT6 program [12] - The net loss for Q3 2025 was $82.2 million, compared to $62.5 million in Q3 2024, with cash and cash equivalents totaling $978.7 million as of September 30, 2025 [14][22]

Core Insights - Kymera Therapeutics announced promising preclinical data for KT-579, an oral degrader of IRF5, showing its potential to modify diseases like lupus and rheumatoid arthritis (RA) [2][3] - The company plans to initiate Phase 1 testing for KT-579 in early 2026 [4] Preclinical Data - KT-579 demonstrated broad activity in preclinical models, with effects comparable or superior to existing therapies for lupus and RA [1][3] - The data presented at the American College of Rheumatology (ACR) Convergence Annual Meeting highlighted KT-579's ability to reduce autoimmune symptoms and disease progression [3][4] Mechanism of Action - KT-579 selectively targets and degrades IRF5, a key regulator of immune responses, thereby suppressing multiple pro-inflammatory pathways [2][3] - In lupus mouse models, KT-579 significantly impacted Type I IFN signaling and pathogenic B cell subsets, leading to reductions in blood interferon-stimulated genes and serum autoantibodies [3][4] Efficacy in Disease Models - In RA rodent models, KT-579 achieved a dose-dependent reduction in joint swelling and inhibited pro-inflammatory cytokines [3][4] - In vitro studies confirmed KT-579's ability to block Th1-skewing cytokines, preventing pathogenic T cell differentiation [3] Future Developments - The company is focused on advancing KT-579 through clinical trials, aiming to provide a new oral treatment option for patients with complex rheumatic and autoimmune diseases [4][6]

Core Insights - Kymera Therapeutics (KYMR) is focused on targeted protein degradation (TPD) to develop drugs for immunological diseases, with significant partnerships with Sanofi and Gilead Sciences to enhance its pipeline [1] Partnership with Sanofi - Sanofi has selected KT-485/SAR447971, an oral candidate targeting IRAK4 for immuno-inflammatory diseases, to advance into clinical studies, following extensive preclinical work [2][3] - Sanofi will discontinue the development of KT-474, which was under evaluation for hidradenitis suppurativa and atopic dermatitis, and will exercise its participation election right for the IRAK4 target [4] - Kymera received a $20 million milestone payment in Q2 2025 related to KT-485, and is eligible for up to $975 million in potential milestones associated with this candidate [4][5] Collaboration with Gilead - Kymera entered an exclusive option and license agreement with Gilead to develop a novel molecular glue degrader (MGD) program targeting CDK2, with potential applications in breast cancer and other solid tumors [6] - The agreement includes an upfront payment of $85 million and potential total payments up to $750 million, along with tiered royalties on net product sales [7][8] Progress with Other Candidates - Kymera's KT-621 has shown strong phase I results in atopic dermatitis, with phase 2b trials planned for 2025-26 [10][11] - The data from KT-621 surpassed expectations, showing comparable efficacy to Dupixent, with ongoing studies expected to report results in Q4 2025 [12] - Kymera is advancing a follow-on oral STAT6 degrader to KT-621 and plans to initiate phase I testing for KT-579 in early 2026 [13] Overall Assessment - The oncology deal with Gilead is promising, providing a significant cash influx, but the delay in milestone payments due to Sanofi's decision to prioritize KT-485 over KT-474 presents challenges [14]

Kymera Therapeutics (KYMR) Conference Summary Company Overview - **Company**: Kymera Therapeutics - **Focus**: Development of targeted protein degradation therapies, particularly in immunology - **Key Products**: KT621 (STAT6 degrader), IRAK4, IRAK5 Core Industry Insights - **Industry**: Biopharmaceuticals, specifically focused on immunology and targeted protein degradation - **Market Need**: There is a significant unmet need for effective oral drugs in immunology, as traditional small molecule inhibitors struggle to block pathways as effectively as biologics [7][8][49] Key Points and Arguments 1. **Platform Evolution**: Kymera has evolved its platform over the past nine years, focusing on developing small molecules that can bind to untracked proteins and create orally available degraders [6][10] 2. **Target Selection**: The company prioritizes targets that have not been drugged before and focuses on pathways with validated efficacy [7][12] 3. **Pipeline Highlights**: The pipeline includes promising programs like STAT6 and IRAK5, which are seen as innovative approaches to treating Th2 inflammation [9][14] 4. **Clinical Development**: The company is transitioning from Phase I to Phase II studies for its STAT6 degrader, with a focus on demonstrating efficacy in atopic dermatitis and asthma [13][18] 5. **Dosing Strategy**: The Phase II studies will explore various dosing levels to determine the optimal degradation of STAT6 and its correlation with clinical efficacy [18][20] 6. **Biomarker Utilization**: The company plans to use established biomarkers for patient selection and efficacy measurement in clinical trials [36][41] 7. **Market Opportunity**: There are approximately 100 million patients with Th2 diseases globally, with a significant portion in the U.S. lacking access to effective treatments [48][49] 8. **Competitive Advantage**: Kymera claims to have a first-mover advantage in the STAT6 space, with data already shared from healthy volunteer studies, positioning it ahead of competitors [51][53] Additional Important Insights - **Machine Learning Integration**: The company is leveraging machine learning to identify new druggable targets and optimize small molecule design [11][12] - **Regulatory Advocacy**: Kymera is actively engaging with regulatory bodies to address disparities in treatment timelines between small molecules and biologics [68][69] - **Future Directions**: The company is focused on advancing its second-generation degraders and ensuring robust manufacturing capabilities as it scales up for Phase III trials [64][65] Conclusion Kymera Therapeutics is positioned as a leader in the biopharmaceutical industry, particularly in the development of innovative oral therapies for immunological conditions. The company's strategic focus on targeted protein degradation, robust clinical pipeline, and commitment to addressing unmet medical needs highlight its potential for significant impact in the market.

Company Overview - Kymera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule degrader medicines for immunological diseases [1][3] - The company aims to transform care for patients with immuno-inflammatory diseases through a portfolio of first-in-class oral medicines [2][3] Leadership Change - Brian Adams has been appointed as Chief Legal Officer and Corporate Secretary, succeeding Ellen Chiniara, who is retiring [1][2] - Mr. Adams brings nearly two decades of experience in the life sciences sector, having held senior legal roles at various biopharmaceutical companies [2] Strategic Focus - Kymera is pioneering the field of targeted protein degradation (TPD) to develop innovative therapies that address health problems not accessible with conventional treatments [3] - The company has advanced its first degrader into clinical trials for immunological diseases and is building a pipeline of oral small molecule degraders [3]

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]

Company Overview - Kymera is a science-driven clinical stage organization focused on developing oral drugs with biologics-like efficacy in immunology[6] - The company has raised $1.7 billion to date, with $850 million in cash on hand, providing a runway to mid-2027[11] - 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[14] Targeted Protein Degradation (TPD) Technology - TPD is a small molecule-based modality with gene silencing power that can unlock the undrugged proteome[23, 22] - TPD has been validated across multiple FDA-approved drugs with >$17 billion in combined peak WW sales[23] - Kymera utilizes comprehensive proprietary technologies to identify novel ligands to undrugged proteins, leading to >8 development candidates, including >4 targeting undrugged transcription factors[39, 41] Immunology Market and Oral Degraders - The immunology market has ~160 million total patients across key immunologic diseases[24] - Approximately 5 million patients (3% of total diagnosed) are on systemic advanced therapies with >$100 billion in annual sales for key I/I indications[28] - In multiple surveys, 75% of patients would switch from injectable biologics to oral with similar profile[31] Pipeline and Clinical Development - KT-474 (IRAK4 degrader) has shown >95% IRAK4 degradation in humans[68] with Phase 2b trials in HS and AD ongoing, with completion expected in 1H 2026 (HS) and mid-2026 (AD)[69] - KT-295 (TYK2 degrader) is undergoing IND-enabling studies with Phase 1 healthy volunteer start planned for 2Q 2025[57] - KT-621 (STAT6 degrader) is in Phase 1 trial with recruitment ongoing and multiple SAD/MAD cohorts completed[92] - Kymera aims to build a STAT6 franchise to serve >130 million diagnosed mild and moderate/severe patients with Th2 inflammation[85]

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]