STAT6

Data from the BroADen Phase 1b atopic dermatitis (AD) patient trial expected to be reported in 4Q25 Completed SAD/MAD dosing in KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025 Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively WATERTOWN, Mass., April 22, 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 recently initiated dosing in its BroADen Phase 1b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD). The Company expects to report data from the BroADen trial in the fourth quarter of 2025. Additionally, the Company has completed SAD/MAD dosing and follow-up in the KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025. “The advancement of KT-621 in patients with AD is an important step in the development of this exciting program and underscores the potential of our unique technology to revolutionize the treatment of complex immuno-inflammatory diseases through oral medicines with biologics-like profiles,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “As the first STAT6-targeted agent in clinical development, we believe KT-621 has the opportunity to dramatically alleviate the burden of disease for those suffering from AD by offering an effective and convenient oral medicine, and we look forward to advancing the clinical program and sharing updates throughout the year.” The BroADen single-arm, open label Phase 1b trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered KT-621 in approximately 20 adult patients with moderate to severe AD. Patients will be administered KT-621 once daily for 28 days. The key study objective is to show that robust STAT6 degradation in blood and skin by KT-621 has a dupilumab-like effect on reducing multiple Th2 biomarkers in the blood and on the transcriptome of active AD skin lesions. The study will also assess effects on clinical endpoints such as Eczema Area and Severity Index (EASI) and pruritus numerical rating scale (NRS). Two parallel Phase 2b clinical trials in moderate to severe AD and asthma patients are expected to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively. These studies are intended to accelerate KT-621 development and enable dose selection for subsequent parallel Phase 3 registration studies across multiple Th2 dermatology, gastroenterology and respiratory indications. About KT-621KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Th2 inflammation. STAT6 degradation has the potential to provide the convenience of an oral medicine with the potential for biologics-like activity and in doing so reach broader patient populations compared to injectable biologics or other standards of care. In preclinical studies, KT-621 demonstrated dupilumab-like activity in several in vitro and in vivo models and was safe and well tolerated. KT-621, the first STAT6 directed medicine to enter clinical evaluation, has the opportunity to transform treatment paradigms for more than 130 million patients around the world, including children and adults, suffering from Th2 diseases such as AD, asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others. More information on the KT-621 BroADen trial in AD will be available on www.clinicaltrials.gov. About Atopic DermatitisAtopic dermatitis (AD) is the most common form of eczema, a chronic inflammatory disease that causes the skin to become inflamed and irritated, making it extremely pruritic (itchy). AD occurs most frequently in children but also affects adults. It can affect a patient’s quality of life and lead to additional complications, such as infections and sleep loss. While there are currently available medicines for AD, such as topical therapies and injectable biologics, there remains a significant unmet need and opportunity to improve treatment options for millions of patients. About Kymera TherapeuticsKymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn. Availability of Other Information About Kymera TherapeuticsFor more information, please visit the Kymera website at https://www.kymeratx.com/ or follow Kymera on X (@KymeraTx) and LinkedIn (Kymera Therapeutics). Investors and others should note that Kymera communicates with its investors and the public using the Company website, including, but not limited to, corporate disclosures, investor presentations, FAQs, Securities and Exchange Commission (SEC) filings, and press releases, as well as on X and LinkedIn. The information that Kymera posts on its website or on X or LinkedIn could be deemed to be material information. As a result, the Company encourages investors, the media and others interested to review the information that Kymera posts there on a regular basis. The contents of Kymera’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and the progress, timing and objectives on the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, the advancement of KT-621 in Phase 1 clinical testing, the expectation that two parallel Phase 2b clinical trials are expected to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively and the intention to accelerate KT-621 development for subsequent parallel Phase 3 registration studies. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target," "upcoming" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future trials and the results of such trials, whether preclinical results will be indicative of the results of clinical trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Annual Report on Form 10-K and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor and Media Contact: Justine KoenigsbergVice President, Investor Relationsinvestors@kymeratx.commedia@kymeratx.com 857-285-5300

WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 8, 2025-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that data from the Company’s Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV) has been accepted for an oral presentation as an ePoster at the European Society of Clinical Microbiology & Infectious Diseases Global 2025 (ESCMID, formerly ECCMID) being held April 11-15, 2025 in Vienna, Austria. The oral ePoster presentation will include results from a Phase 2a human challenge study of EDP-323, a first-in-class, oral, non-nucleoside small-molecule inhibitor of the RSV polymerase (L-protein), which were announced in September 2024 and highlight new data on respiratory mucus production. ePoster Title: “EDP-323, a First-in-Class, Oral, RSV L-Protein Inhibitor Reduces Disease Severity (Respiratory Mucus Production) and Accelerates Viral Clearance in a Human Viral Challenge Study” ePoster Number: E0289 Abstract Number: 04019 Date and Time: April 13, 2025, 8:30 a.m. CEST/ 2:30 a.m. EDT Session Location: Arena 1 Session Title: Novel Approaches to Antiviral Therapy Presenter: John P. DeVincenzo, M.D. The scientific program for ESCMID Global 2025 can be found here. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information. View source version on businesswire.com: https://www.businesswire.com/news/home/20250408012708/en/ Media and Investor Contact Jennifer Viera 617-744-3848 jviera@enanta.com Source: Enanta Pharmaceuticals, Inc.

Sanofi has agreed to pay up to $465 million in milestones for exclusive rights to the latest program. \n Sanofi has returned to Nurix Therapeutics for another autoimmune candidate, paying $15 million and committing up to $465 million for exclusive rights to a degrader of a once-undruggable transcription factor.Nurix has landed deals with Sanofi and Gilead and built an internal pipeline on a platform for identifying agents that use E3 ligases to drive the degradation of targets. Sanofi paid $55 million to partner with the biotech in 2019 and handed over a further $22 million to expand the collaboration one year later. Nurix and Sanofi extended the deal again last year to cover a STAT6 degrader. The latest deal covers a new, previously undisclosed program. Sanofi and Nurix are keeping the target under wraps for now, but Gwenn Hansen, Ph.D., chief scientific officer at the biotech, offered some clues in a statement.“This high-value target is a transcription factor involved in the regulation of proinflammatory cytokines serving as a central regulator of inflammation response in autoimmune diseases where targeted protein degradation could offer an innovative treatment option,” Hansen said. Like other developers of protein degraders, Nurix pitches its technology as a way to go after targets that have been considered undruggable, for example, because they lack viable binding sites. Hansen said the company used its platform to identify “novel binders from which we derived a series of targeted protein degraders and stand-alone target binders” for the new Sanofi target.The $15 million upfront brings the amount Sanofi has paid Nurix to date up to $105 million. That figure could swell in the coming years. Sanofi has agreed to pay up to $465 million in milestones for exclusive rights to the latest program. The potential paydays add to the $1.9 billion that Nurix was eligible for at the end of November. Nurix has the option to co-develop and co-promote the latest candidate in the U.S. How much Sanofi pays Nurix will depend on the progress of its programs. Nurix plans to give Sanofi the STAT6 development candidate package in the first half of 2025. The Big Pharma has an option to take the candidate through IND-enabling studies and into the clinic. Partnerships have helped Nurix build a cash cushion that stood at more than $600 million at the end of November. The biotech is using the money to advance a pipeline led by NX-5948, a BTK degrader that is on course to enter trials this year to support approval in chronic lymphocytic leukemia.