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Kymera Therapeutics Announces First Patient Dosed in BROADEN Phase 1b Atopic Dermatitis Clinical Trial of KT-621, a First-in-Class Oral STAT6 Degrader
Newsfilter· 2025-04-22 11:00
Core Insights - Kymera Therapeutics has initiated dosing in the BroADen Phase 1b clinical trial for KT-621, targeting moderate to severe atopic dermatitis (AD), with data expected in Q4 2025 [1][2] - The company has completed the SAD/MAD dosing in the KT-621 Phase 1 healthy volunteer trial, with results anticipated in June 2025 [1] - Two parallel Phase 2b trials for KT-621 in AD and asthma are planned to commence in Q4 2025 and Q1 2026, respectively [3] Company Overview - Kymera Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral small molecule degrader medicines for immunological diseases [1][8] - The company aims to revolutionize treatment for complex immuno-inflammatory diseases through its unique technology, which offers biologics-like profiles in an oral format [2][4] - KT-621 is the first STAT6-targeted agent in clinical development, with the potential to significantly alleviate the burden of AD through effective oral administration [2][4] Clinical Trial Details - The BroADen Phase 1b trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of KT-621 in approximately 20 adult patients with moderate to severe AD [2] - The primary objective is to demonstrate robust STAT6 degradation and its effects on Th2 biomarkers, alongside clinical endpoints like the Eczema Area and Severity Index (EASI) [2] - The upcoming Phase 2b trials are designed to accelerate the development of KT-621 and facilitate dose selection for subsequent Phase 3 studies across various Th2-related conditions [3] Product Information - KT-621 is a first-in-class, once-daily oral degrader of STAT6, which is crucial for IL-4/IL-13 signaling and Th2 inflammation [4] - Preclinical studies have shown that KT-621 exhibits dupilumab-like activity, indicating its potential effectiveness in treating Th2 diseases [4] - The drug aims to provide a more convenient treatment option compared to injectable biologics, potentially reaching a broader patient population [4][6] Market Context - Atopic dermatitis (AD) is a prevalent chronic inflammatory skin condition that significantly impacts patients' quality of life, with a notable unmet need for improved treatment options [6] - Current treatments include topical therapies and injectable biologics, but there remains a significant opportunity for new oral therapies like KT-621 to address this need [6]
Kymera Therapeutics (KYMR) Moves 13.8% Higher: Will This Strength Last?
ZACKS· 2025-04-10 15:10
Kymera Therapeutics, Inc. (KYMR) shares ended the last trading session 13.8% higher at $23.95. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 36.7% loss over the past four weeks.Shares rallied due to broader market optimism following President Trump's tweet that there would be a 90-day pause on reciprocal tariffs for non-retaliating countries. Kymera also announced the appointment of Noah Goodman as its new Chief ...
Kymera Therapeutics Appoints Noah Goodman as Chief Business Officer
Newsfilter· 2025-04-09 11:00
WATERTOWN, Mass., April 09, 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 the appointment of Noah Goodman, M.B.A., as Chief Business Officer. Mr. Goodman brings a wealth of diverse experience in the life sciences industry to Kymera and will lead business development strategy and activities for the company. "We continue to stay focused on o ...
Kymera's Q4 Loss Wider Than Expected, Pipeline in Focus
ZACKS· 2025-02-28 19:16
Kymera Therapeutics, Inc. (KYMR) reported a fourth-quarter 2024 loss of 88 cents per share, wider than the Zacks Consensus Estimate of a loss of 76 cents. In the year-ago quarter, Kymera reported a loss of 25 cents per share.The year-over-year deterioration was due to lower collaboration revenues and higher operating expenses.Collaboration revenues totaled $7.4 million, which missed the Zacks Consensus Estimate of $13 million.In the year-ago quarter, Kymera earned collaboration revenues of $47.9 million due ...
Kymera Therapeutics(KYMR) - 2024 Q4 - Earnings Call Transcript
2025-02-27 19:48
Kymera Therapeutics, Inc. (NASDAQ:KYMR) Q4 2024 Earnings Conference Call February 27, 2025 8:30 AM ET Company Participants Justine Koenigsberg - Vice President-Investor Relations Nello Mainolfi - Founder, President & Chief Executive Officer Jared Gollob - Chief Medical Officer Bruce Jacobs - Chief Financial Officer Conference Call Participants Faisal Khurshid - Leerink Partners Andy Chen - Wolfe Research Paul Jeng - Guggenheim Ron Feiner - JPMorgan Jeff Jones - Oppenheimer Brad Canino - Stifel Marc Frahm - ...
Kymera Therapeutics(KYMR) - 2024 Q4 - Earnings Call Presentation
2025-02-27 14:47
Introduction Justine Koenigsberg, Vice President, Investor Relations Kymera Therapeutics Fourth Quarter & Full Year 2024 Quarterly Results Call February 27, 2025 Agenda Key Highlights & Business Update Nello Mainolfi, PhD, Founder, President and Chief Executive Officer Clinical Update Jared Gollob, MD, Chief Medical Officer Financial Review Bruce Jacobs, CFA, MBA, Chief Financial Officer Question and Answer Session Forward Looking Statements This presentation contains forward-looking statements within the m ...
Kymera Therapeutics, Inc. (KYMR) Reports Q4 Loss, Misses Revenue Estimates
ZACKS· 2025-02-27 14:20
Kymera Therapeutics, Inc. (KYMR) came out with a quarterly loss of $0.88 per share versus the Zacks Consensus Estimate of a loss of $0.76. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -15.79%. A quarter ago, it was expected that this company would post a loss of $0.83 per share when it actually produced a loss of $0.82, delivering a surprise of 1.20%.Over the last four quarters, the company ha ...
Kymera Therapeutics(KYMR) - 2024 Q4 - Annual Report
2025-02-27 12:15
Financial Position and Funding - As of December 31, 2024, the company had cash and cash equivalents of $850.9 million, which is expected to fund operations into mid-2027[203]. - The company reported net losses of $223.9 million, $147.0 million, and $154.8 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $754.6 million as of December 31, 2024[199]. - The company will need to raise substantial additional funding to support its operations and product candidate development, which may lead to dilution of existing stockholders[202][207]. - Future capital requirements may increase significantly based on various factors, including the scope and progress of drug discovery and clinical trials[205]. - The company may face challenges in accessing funding sources due to adverse developments in the financial services industry[210][211]. - The company anticipates continued increased costs associated with operating as a public company, impacting management's focus on business operations[208]. Research and Development - The company has never generated revenue from drug sales and does not expect to do so in the near future[213]. - Significant expenses are anticipated for ongoing preclinical studies and clinical trials, as well as for preparing and submitting Investigational New Drug applications[200]. - The approach to product candidate discovery and development is novel and unproven, making it difficult to predict development time and costs[216]. - All product candidates are currently in preclinical or early clinical development, with potential adverse effects that cannot be predicted at this time[217]. - The company is focusing on its immunology portfolio, specifically the STAT6, TYK2, and IRAK4 programs, while discontinuing KT-413, KT-333, and KT-253 programs to allocate resources more effectively[219]. - The company is developing KT-474 for a broad set of immunology-inflammation diseases, including HS, AD, and rheumatoid arthritis[230]. - KT-621 is being developed for various immunology indications, including AD, asthma, COPD, CRSwNP, EoE, and PN[230]. - KT-295 targets immunology indications such as inflammatory bowel disease, psoriasis, psoriatic arthritis, and lupus[230]. - The company faces potential setbacks in clinical trials, as positive preclinical results may not predict later trial outcomes[228]. - Adverse side effects from product candidates could delay or prevent regulatory approval and limit commercial profiles[234]. - Manufacturing complexities may lead to delays or increased costs in providing supplies for clinical trials and commercial purposes[240]. Regulatory Challenges - Regulatory approval processes for product candidates are complex, lengthy, and uncertain, with potential delays or denials for various reasons[221]. - Delays in patient enrollment for clinical trials could hinder the receipt of necessary regulatory approvals[223]. - The company may face challenges in demonstrating the safety and efficacy of product candidates to regulatory authorities, impacting approval chances[224]. - The process of obtaining regulatory approvals is expensive and may take many years, with potential delays due to additional clinical trials or changes in regulatory policies[245]. - The company may seek Breakthrough Therapy Designation and/or Fast Track Designation for its product candidates, but these designations do not guarantee faster development or approval[249]. - The company may apply for Orphan Drug Designation for certain product candidates, which could provide financial incentives, but there is no assurance of maintaining these benefits[252]. - If the company receives regulatory approval, it will be subject to ongoing obligations and regulatory review, which may result in significant additional expenses[256]. - The FDA's policies may change, and new regulations could prevent or delay regulatory approval for current or future product candidates[257]. - The company may need to conduct additional clinical trials to demonstrate comparability of clinical supplies if there are changes in manufacturing processes[244]. - Regulatory authorities may approve product candidates for fewer or more limited indications than requested, impacting commercial prospects[247]. - The company relies on third-party CROs and regulatory consultants for regulatory approval processes, which may introduce additional risks[244]. - Inadequate funding for the FDA and SEC could hinder product development and commercialization, impacting business operations[258]. - A prolonged government shutdown may significantly delay FDA's review and processing of regulatory submissions, adversely affecting business[259]. - Regulatory approval for products outside the U.S. may involve additional testing and administrative review, potentially delaying market entry[260]. - Foreign markets present additional regulatory burdens and risks that could materially affect business growth[261]. Market and Competitive Landscape - The commercial success of the company's product candidates will depend on market acceptance among physicians, patients, and payors[287]. - The company faces substantial competition from other firms in drug development, which may have greater financial resources and expertise[290]. - Competitors may develop safer or more effective drugs, potentially reducing the company's market opportunity[293]. - Product liability lawsuits could expose the company to significant liabilities, impacting the commercialization of its product candidates[294]. - The company currently lacks a sales and marketing infrastructure, which may hinder the successful commercialization of its product candidates[296]. - Recruiting and training a sales force is expected to be expensive and time-consuming, potentially delaying drug launches[297]. Intellectual Property Risks - The patent position for biotechnology and pharmaceutical companies is uncertain, with complex legal questions and potential litigation risks[318]. - The company relies on patent applications and trade secrets to protect its proprietary technologies, including TPD expertise and advanced development programs[317]. - Patent protection may be limited, and the company cannot guarantee that pending applications will provide sufficient coverage for its product candidates[320]. - The patent prosecution process is expensive and time-consuming, which may hinder the ability to file and maintain necessary applications[322]. - The company may face challenges in enforcing intellectual property rights in foreign jurisdictions, where protections may be less extensive[330]. - The company may need to license third-party technologies to commercialize its products, which could be difficult and may not yield favorable terms[333]. - The crowded intellectual property landscape increases the risk of infringement claims, which could lead to costly litigation and impact the company's financial condition[360]. - The company may be required to obtain licenses from third parties to commercialize its product candidates, which may not be available on commercially reasonable terms[366]. Operational and Compliance Risks - The company is subject to various data protection laws, including the EU GDPR, which could impose significant compliance costs and risks[384]. - Non-compliance with data protection regulations could result in fines up to €20 million or 4% of global annual revenues, whichever is higher[384]. - Cyberattacks and security breaches pose a significant risk to the company's operations and could lead to financial and reputational harm[380]. - The company must effectively manage its expansion to avoid operational mistakes and increased expenses that could impact revenue generation[374]. - The company is exposed to risks of misconduct by employees and third parties, which could lead to regulatory sanctions and reputational harm[283]. - The company must ensure compliance with environmental, health, and safety regulations, as non-compliance could lead to fines and adversely affect business success[281]. Workforce and Infrastructure - As of December 31, 2024, the company had 188 full-time employees and plans to increase its workforce and operational scope[373]. - The company currently leases 34,522 square feet of research and development and office space, with a lease expiring on March 31, 2030, and has moved to a new facility of 100,624 square feet[378]. - The company may incur unexpected costs if unable to sublease its former space in Watertown, Massachusetts[378]. - The company does not maintain "key person" insurance for its executives, which could pose risks if key personnel leave[371]. - Competition for hiring qualified personnel is intense, particularly for scientific and clinical roles, which may hinder the company's growth strategy[372]. - The company relies on third-party contractors for critical operations, and any disruptions could materially affect its business[379]. Market Conditions and External Factors - The stock price has been volatile, influenced by factors such as competitive drug success, clinical trial results, regulatory developments, and geopolitical events, which may lead to substantial fluctuations in market demand[389]. - The ongoing geopolitical tensions, including conflicts in Ukraine and the Middle East, may adversely affect the company's financial condition and stock price due to market instability[391]. - The recent imposition of tariffs, including a 25% tariff on imports from Canada and Mexico, could lead to increased trade tensions and negatively impact the company's operations[392]. - The company is committed to implementing governance and control mechanisms to mitigate risks associated with AI and machine learning, but there is no assurance that these measures will be fully effective[388]. - The market price of the company's common stock may be disproportionately affected by broader market conditions, particularly during periods of uncertainty and instability[390].
Kymera Therapeutics(KYMR) - 2024 Q4 - Annual Results
2025-02-27 12:13
Exhibit 99.2 January 2025 J.P. Morgan Healthcare Conference Nello Mainolfi, Ph.D., Founder, President and CEO ,KYMERA This presentation contains forward-looking statements within the meanine of the Private Securities Litiation Reform Act of 1995 and other federal securities laws. These statements include, but are not limited to, inplied and express statements about our stratesy, business plans and digictives for the inclinerines for the preclinical and cl regarding timing, success and data announcements of ...
Kymera Therapeutics Announces Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update
GlobeNewswire· 2025-02-27 12:00
KT-621 (STAT6) Phase 1 healthy volunteer trial ongoing, complete SAD/MAD data expected in June 2025 KT-621 Phase 1b trial in atopic dermatitis (AD) patients expected to initiate in 2Q25 with data in 4Q25, followed by two parallel Phase 2b trials in AD and asthma starting in 4Q25 and 1Q26, respectively KT-295 (TYK2) Phase 1 trial is expected to start in 2Q25, with data expected in 4Q25 KT-474/SAR444656 (IRAK4) Phase 2b trials in hidradenitis suppurativa (HS) and AD ongoing, led by partner Sanofi, with primar ...