Kymera Therapeutics Outlines Key 2025 Objectives and Strategy to Advance Industry Leading Portfolio of Oral Immunology Programs
Kymera Therapeutics (NASDAQ: KYMR) has outlined its key objectives for 2025, focusing on advancing its oral immunology programs. The company's lead candidate, KT-621, a STAT6 degrader, is in Phase 1 trials with data expected in Q2 2025, followed by Phase 1b trials in atopic dermatitis. Their KT-295 TYK2 degrader will advance to Phase 1 testing in Q2 2025, while KT-474/SAR444656 Phase 2b studies in hidradenitis suppurativa and atopic dermatitis are ongoing.
The company plans to disclose a novel oral immunology program in H1 2025. With an estimated $850 million in cash, Kymera has runway into mid-2027. Their strategy focuses on developing oral drugs with biologics-like activity for treating inflammatory diseases, particularly targeting conditions like atopic dermatitis, asthma, and other Th2-driven diseases affecting over 130 million patients globally.
Kymera Therapeutics (NASDAQ: KYMR) ha delineato i suoi obiettivi chiave per il 2025, concentrandosi sull'avanzamento dei suoi programmi di immunologia orale. Il candidato principale dell'azienda, KT-621, un degrader di STAT6, è attualmente in fase di sperimentazione di Fase 1, con dati attesi nel secondo trimestre del 2025, seguiti dalla fase 1b in dermatite atopica. Il loro KT-295, degrader di TYK2, avanzerà alla fase di test 1 nel secondo trimestre del 2025, mentre gli studi di fase 2b su KT-474/SAR444656 in idradenite suppurativa e dermatite atopica sono in corso.
L'azienda prevede di rivelare un nuovo programma di immunologia orale nel primo semestre del 2025. Con circa 850 milioni di dollari in contanti, Kymera ha un margine di manovra fino a metà 2027. La loro strategia si concentra sullo sviluppo di farmaci orali con attività simile a quella dei biologici per il trattamento delle malattie infiammatorie, mirando particolarmente a condizioni come la dermatite atopica, l'asma e altre malattie guidate da Th2 che colpiscono oltre 130 milioni di pazienti a livello globale.
Kymera Therapeutics (NASDAQ: KYMR) ha delineado sus objetivos clave para 2025, centrándose en avanzar sus programas de inmunología oral. El candidato principal de la compañía, KT-621, un degradador de STAT6, se encuentra en ensayos de Fase 1 con datos esperados en el segundo trimestre de 2025, seguidos de ensayos de fase 1b en dermatitis atópica. Su degradador KT-295 de TYK2 avanzará a pruebas de Fase 1 en el segundo trimestre de 2025, mientras que los estudios de Fase 2b de KT-474/SAR444656 en hidradenitis supurativa y dermatitis atópica están en curso.
La compañía planea revelar un nuevo programa de inmunología oral en la primera mitad de 2025. Con aproximadamente 850 millones de dólares en efectivo, Kymera tiene margen hasta mediados de 2027. Su estrategia se centra en desarrollar medicamentos orales con actividad similar a la de los biológicos para tratar enfermedades inflamatorias, enfocándose particularmente en condiciones como dermatitis atópica, asma y otras enfermedades impulsadas por Th2 que afectan a más de 130 millones de pacientes a nivel mundial.
Kymera Therapeutics (NASDAQ: KYMR)는 2025년의 주요 목표를 설정하고 경구 면역학 프로그램을 발전시키는 데 집중하고 있습니다. 회사의 주요 후보인 KT-621은 STAT6 분해제로, 2025년 2분기에 데이터가 예상되는 1상 시험 중이며, 이후 아토피 피부염에 대한 1b상 시험이 예정되어 있습니다. KT-295 TYK2 분해제는 2025년 2분기에 1상 시험으로 진행될 예정이며, KT-474/SAR444656의 2b상 연구는 수포성 피부염과 아토피 피부염에서 진행되고 있습니다.
회사는 2025년 상반기에 새로운 경구 면역학 프로그램을 발표할 계획입니다. 약 8억 5천만 달러의 현금을 보유한 Kymera는 중반 2027년까지의 여유를 갖고 있습니다. 그들의 전략은 염증성 질환 치료를 위한 생물학적 제제와 유사한 활성을 가진 경구 약물 개발에 중점을 두고 있으며, 아토피 피부염, 천식 및 1억 3천만 명 이상의 환자에게 영향을 미치는 Th2 주도 질환과 같은 상태를 특히 목표로 하고 있습니다.
Kymera Therapeutics (NASDAQ: KYMR) a exposé ses objectifs clés pour 2025, en se concentrant sur l'avancement de ses programmes d'immunologie orale. Le principal candidat de l'entreprise, KT-621, un dégradeur de STAT6, est en essais de Phase 1, avec des données attendues au 2e trimestre 2025, suivies d'essais de Phase 1b dans la dermatite atopique. Leur dégradeur KT-295 de TYK2 avancera à des essais de Phase 1 au 2e trimestre 2025, tandis que les études de Phase 2b pour KT-474/SAR444656 sur l'hidradenitis suppurativa et la dermatite atopique sont en cours.
L'entreprise prévoit de dévoiler un nouveau programme d'immunologie orale au 1er semestre 2025. Avec environ 850 millions de dollars en liquidités, Kymera dispose de marges de manœuvre jusqu'à mi-2027. Leur stratégie se concentre sur le développement de médicaments oraux avec une activité similaire à celle des biologiques pour traiter les maladies inflammatoires, ciblant particulièrement des conditions telles que la dermatite atopique, l'asthme et d'autres maladies à médiation Th2 qui affectent plus de 130 millions de patients dans le monde.
Kymera Therapeutics (NASDAQ: KYMR) hat seine wesentlichen Ziele für 2025 umrissen und konzentriert sich auf die Weiterentwicklung seiner oralen Immunologie-Programme. Der Hauptkandidat des Unternehmens, KT-621, ein STAT6-Degrader, befindet sich in Phase-1-Studien, von denen im 2. Quartal 2025 Daten erwartet werden, gefolgt von Phase-1b-Studien zur atopischen Dermatitis. Ihr KT-295 TYK2-Degrader wird im 2. Quartal 2025 in die Phase-1-Tests übergehen, während die Phase-2b-Studien zu KT-474/SAR444656 bei hidradenitis suppurativa und atopischer Dermatitis laufen.
Das Unternehmen plant, im ersten Halbjahr 2025 ein neues orales Immunologie-Programm bekannt zu geben. Mit geschätzten 850 Millionen Dollar an Barmitteln hat Kymera Spielraum bis Mitte 2027. Ihre Strategie konzentriert sich auf die Entwicklung oraler Medikamente mit biologischer Aktivität zur Behandlung von entzündlichen Erkrankungen, insbesondere bei der Ansprache von Erkrankungen wie atopischer Dermatitis, Asthma und anderen Th2-gesteuerten Erkrankungen, die weltweit über 130 Millionen Patienten betreffen.
- Strong cash position of $850 million providing runway into mid-2027
- Multiple clinical milestones expected across three programs in 2025
- Broad market potential with KT-621 targeting over 130 million patients globally
- No revenue-generating products in the market yet
- Primary completion of Phase 2b trials not expected until 2026
Insights
The KT-621 (STAT6) program presents a compelling strategic advancement in immunology therapeutics. The progression through Phase 1 with planned expansion into Phase 1b and Phase 2b trials in 2025 follows an aggressive but well-structured development timeline. The focus on atopic dermatitis and asthma as lead indications is strategically sound, given the 130 million patient market potential and established clinical endpoints.
The TYK2 degrader (KT-295) program's advancement to Phase 1 represents a significant milestone in the company's pipeline diversification. The preclinical data suggesting biologics-like activity through oral administration could be transformative for inflammatory conditions treatment. The $850.1 million cash position providing runway into mid-2027 adequately supports the ambitious clinical development timeline across multiple programs.
The IRAK4 program's ongoing Phase 2b trials in partnership with Sanofi adds credibility and reduces development risk. The structured approach to data readouts throughout 2025-2026 creates multiple potential value-inflection points.
The company's strategic positioning in the oral immunology space with multiple first-in-class candidates presents significant market opportunity. The targeted indications, particularly atopic dermatitis and asthma, represent high-value markets currently dominated by injectable biologics. A successful oral alternative with comparable efficacy could capture substantial market share.
The partnership with Sanofi for KT-474 provides important validation and financial support. The company's robust cash position of $850.1 million significantly de-risks the development pathway and strengthens negotiating positions for future partnerships. The planned pipeline expansion with a new program disclosure in 1H25 demonstrates continued innovation and pipeline growth potential.
The company's financial position is robust with $850.1 million in cash providing runway into mid-2027, covering multiple critical clinical milestones. The strategic timing of clinical trials and data readouts throughout 2025-2026 creates numerous potential catalysts for stock appreciation. The Sanofi partnership for KT-474 provides additional financial flexibility and validation.
Key value drivers include the Phase 1 data for KT-621 in 2Q25, Phase 1b AD data in 4Q25 and TYK2 Phase 1 data in late 2025. The market potential across multiple high-value indications and the first-in-class positioning of several candidates could drive significant valuation upside. With a current market cap of $2.3 billion, successful clinical execution could lead to substantial value creation.
KT-621 (STAT6) Phase 1 healthy volunteer trial ongoing, with data expected in 2Q25
Kymera plans to initiate a KT-621 Phase 1b trial in atopic dermatitis (AD) patients in 2Q25 with data in 4Q25 and plans to initiate parallel Phase 2b trials in AD and asthma in late 2025 and early 2026, respectively
KT-295 (TYK2) to advance into Phase 1 testing in 2Q25 with data expected in late 2025
KT-474/SAR444656 (IRAK4) Phase 2b dose-ranging studies in hidradenitis suppurativa (HS) and AD ongoing, with completion expected in 1H26 and mid-2026, respectively
Novel oral immunology program with a first-in-class development candidate to be disclosed in 1H25
Well-capitalized with
Kymera to present its 2025 outlook at J.P. Morgan Annual Healthcare Conference on
Tuesday, January 14, 2025, at 9:00 a.m. PT/12:00 p.m. ET
WATERTOWN, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines with biologics-like activity for immunological diseases, today announced its corporate goals for 2025, including anticipated progress on its clinical pipeline of immunology programs.
“We expect 2025 to be another year of significant progress and accomplishments, and likely our busiest year to date. After unveiling our broader immunology strategy and new pipeline last year, we are poised to demonstrate the clinical potential of our first-in-class, wholly owned STAT6 and TYK2 oral degrader programs,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “Our vision is to leverage the power of targeted protein degradation to deliver, for the first time in industry, oral drugs with biologics-like activity that have the potential to revolutionize the treatment of many inflammatory diseases with significant unmet needs. We are rapidly progressing the development of our first-in-industry oral STAT6 degrader, KT-621, and will have Phase 1 healthy volunteer data, Phase 1b atopic dermatitis data, as well as initiate the first Phase 2b study, all in 2025.”
Dr. Mainolfi continued, “In addition to the significant progress we expect with our disclosed immunology programs, we look forward to expanding our immunology pipeline with a new program disclosure in the first half of 2025, continuing to build what we believe is the best oral immunology portfolio in industry.”
Additional details around Kymera's pipeline, including its development plans for KT-621, will be presented today at the J.P. Morgan Healthcare Conference.
Program updates on the company's disclosed programs and platform include:
STAT6 Degrader Program
KT-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. Currently in Phase 1 testing, KT-621 has demonstrated dupilumab-like activity and very good safety data in preclinical models. Recruiting for the KT-621 Phase 1 heathy volunteer trial is ongoing, with multiple single ascending dose (SAD) and multiple ascending dose (MAD) cohorts completed. KT-621 has the potential to address numerous Th2 diseases including 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. Kymera intends to develop KT-621, an oral drug with potential for biologics-like efficacy, with the goal of transforming the treatment paradigm for the more than 130 million patients (children and adults) in the world suffering from Th2 diseases.
Key upcoming KT-621 milestones:
- Complete KT-621 Phase 1 healthy volunteer clinical trial and report data in the second quarter of 2025.
- Advance KT-621 into a Phase 1b clinical trial in AD patients in the second quarter of 2025 and report data in the fourth quarter of 2025.
- Initiate KT-621 Phase 2b clinical trial in AD in the fourth quarter of 2025, followed by a Phase 2b clinical trial in asthma in early 2026.
TYK2 Degrader Program
KT-295 is an investigational, first-in-class, once daily, oral degrader of TYK2, a member of the Janus kinase (JAK) family required for Type I IFN, IL-12 and IL-23 signaling. Given KT-295’s ability, observed in preclinical studies, to replicate the human genetic loss of function profile of TYK2, and to block the pathway to the level of upstream biologics (e.g., anti-IL-23), KT-295 has the potential to be the first oral therapy to deliver biologics-like activity in diseases such as IBD, psoriasis and others.
Key upcoming KT-295 milestones:
- File KT-295 IND and initiate dosing in the Phase 1 healthy volunteer clinical trial in the second quarter of 2025, with Phase 1 data expected in the fourth quarter of 2025.
IRAK4 Degrader Program
KT-474 (SAR444656) is an investigational, first-in-class, once daily, oral degrader of IRAK4, a key protein involved in TLR/IL-1R-driven inflammation. Given IRAK4’s ability to block IL-1 family cytokine and TLR signaling, KT-474 holds promise to be superior to individual upstream cytokines blockers (e.g., anti-IL-1, anti-IL-33) as an oral drug. Initial Phase 2b clinical trials for HS and AD, in collaboration with Sanofi, are currently ongoing with potential in the future to expand beyond these two indications.
Key upcoming KT-474 milestones:
- Collaborate with Sanofi to advance the KT-474/SAR444656 (IRAK4) Phase 2b dose-ranging clinical trials in HS and AD, with primary completion expected in the first half of 2026 for HS and mid-2026 for AD.
Research Platform
Leveraging its proven small molecule discovery capabilities, deep expertise, and unique target selection strategy, Kymera is building an industry leading portfolio of innovative oral immunology medicines addressing high value undrugged or poorly-drugged targets for areas of significant need.
Key upcoming pipeline disclosures:
- Kymera plans to announce the next immunology program, a first-in-class development candidate addressing an undrugged transcription factor, in the first half of 2025, and initiate clinical testing in early 2026.
For more information on Kymera’s pipeline visit our website.
J.P. Morgan Healthcare Conference Webcast
Kymera will present its 2025 outlook at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, at 9:00 a.m. PT (12:00 p.m. ET). A live webcast of the presentation and Q&A session will be available under “News and Events” in the Investors section of the Company’s website at www.kymeratx.com. A replay of the webcast and the presentation will be archived on Kymera’s website following the event.
1Unaudited, estimated cash as of December 31, 2024.
About Kymera Therapeutics
Kymera 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.
Cautionary Note Regarding Forward-Looking Statements
This 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 objectives on the clinical development of clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, Sanofi’s expansion of the Phase 2 clinical trials of KT-474/SAR444656, the Phase 1 data readout of KT-621 in the first half of 2025, the advancement of KT-295 into Phase 1 clinical testing, the declaration of its next clinical candidate and filing of an IND in second half of 2025, and Kymera’s financial condition and expected cash runway into mid-2027. 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 clinical trials and the results of such trials, whether preliminary results of early clinical trials will be indicative of the results of later 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 Quarterly Report on Form 10-Q and in subsequent filings with the Securities and Exchange Commission. 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 Koenigsberg
Vice President, Investor Relations
investors@kymeratx.com
media@kymeratx.com
857-285-5300
FAQ
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