Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $7.4 million, entirely from the Sanofi collaboration [36] - R&D expenses for the quarter were $71.8 million, with adjusted cash R&D spend of $65 million reflecting a 23% sequential increase from Q3 [37] - G&A expenses were $16.3 million, with adjusted cash G&A spend of $9.3 million, up 13% sequentially [37] - Cash balance at the end of 2024 was $851 million, providing a runway into mid-2027 [38] Business Line Data and Key Metrics Changes - The company is focused on advancing its immunology pipeline, particularly with the STAT6 and TYK2 programs [8][12] - Progress in the STAT6 program includes completing IND-enabling studies for KT-621 and initiating a Phase I healthy volunteer study [9][10] - The TYK2 program is advancing with the development candidate KT-295, with plans to start a Phase I healthy volunteer study [11][30] Market Data and Key Metrics Changes - The company aims to develop therapies that provide biologic-like efficacy with the convenience of an oral daily pill, targeting a broad patient population [8][16] - The strategic focus on immunology is expected to expand access to millions of patients globally [8] Company Strategy and Development Direction - Kymera is committed to developing an industry-leading immunology pipeline featuring innovative oral small molecule therapies [16] - The goal is to deliver at least one new IND per year, with multiple clinical advancements expected in 2025 [15][34] - The company plans to unveil a new immunology target in May, which aligns with its pipeline strategy [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in 2024 and the potential for a productive 2025 with several clinical advancements [12][34] - The company believes that its oral medicines can provide a differentiated solution compared to traditional small molecules and biologics [17] Other Important Information - The company is transitioning its quarterly financial updates to a video format to enhance transparency and communication with stakeholders [7] - A director, Leigh Morgan, will not stand for reelection at the upcoming Annual Shareholder Meeting [18] Q&A Session Summary Question: What supports your view that the 28 dosing in the atopic derm Phase Ib is enough time to show robust biomarker activity? - Management referenced prior dupilumab trials showing clear impacts on Th2 biomarkers at four weeks, indicating confidence in the 28-day study design [43][44] Question: Can you comment on the choice to not have a placebo arm in the Phase 1b? - Management believes that a placebo is unnecessary for demonstrating biomarker profiles, as biomarkers do not significantly change in placebo arms [49][50] Question: What do we know about the potential bioavailability of KT-621 in tissues of interest? - Preclinical data indicates that KT-621 is orally bioavailable and shows consistent degradation across various tissues, including skin and lungs [65][66] Question: How expansive of a Phase 3 development program would you expect to initiate for KT-621? - The company plans to run important Phase 2b studies to inform Phase 3 selection for potentially eight different indications, prioritizing asthma and atopic dermatitis [137][138]

Business Highlights - Kymera Therapeutics introduced its immunology development strategy and unveiled two new programs: STAT6 and TYK2[7] - The company filed and cleared KT-621 (STAT6) IND and initiated a Phase 1 healthy volunteer trial[7] - KT-295 (TYK2) was declared as the lead development candidate[7] - Kymera Therapeutics raised approximately $600 million, extending the cash runway into mid-2027[7] Clinical Development - KT-621 (STAT6): Phase 1b study in atopic dermatitis patients is expected to start in 2Q25, with results reported in 4Q25; Phase 2b study in atopic dermatitis patients is planned for 4Q25, followed by a Phase 2b study in asthma patients in 1Q26[9] - KT-295 (TYK2): Phase 1 trial in healthy volunteers is expected to begin in 2Q25, with results reported in 4Q25[9] - KT-474 (IRAK4): Phase 2b trials in hidradenitis suppurativa (HS) and atopic dermatitis (AD) are ongoing, with primary completion expected in 1H 2026 (HS) and mid-2026 (AD)[23] Financial Results - Collaboration revenue for the three months ended December 31, 2024, was $7394 thousand, compared to $47884 thousand for the same period in 2023[25] - Research and development expenses for the three months ended December 31, 2024, were $71818 thousand, compared to $52970 thousand for the same period in 2023[25] - Net loss for the three months ended December 31, 2024, was $70753 thousand, compared to $14369 thousand for the same period in 2023[25] - Cash, cash equivalents, and marketable securities totaled $850903 thousand as of December 31, 2024, compared to $436315 thousand as of December 31, 2023[25]

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 ...

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].

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 ...

WATERTOWN, Mass., Feb. 26, 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 the Company will participate in fireside chats at the following upcoming investor events: TD Cowen 45th Annual Healthcare Conference in Boston, MA on March 5 at 9:10 a.m. ET;Leerink Partners Global Biopharma Conference in Miami, FL on March 11 at 8:00 a.m. ET;Je ...

WATERTOWN, Mass., Feb. 20, 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, will report fourth quarter and full year 2024 financial results on February 27, 2025. The Company will host a new video conference call format at 8:30 a.m. ET that day. To join the video call or view the livestreamed webcast, please register via this lin ...

Kymera Therapeutics (KYMR) Conference Call Summary Company Overview - **Company**: Kymera Therapeutics (KYMR) - **Focus**: Targeted protein degradation to develop new medicines, particularly in the field of immunology and autoimmune diseases [4][5] Strategic Priorities - **Immunology Strategy**: The company aims to advance and expand its autoimmune disease target portfolio, leveraging targeted protein degradation to create oral drugs with biologics-like efficacy [3][4][5] - **Current Programs**: - IREC4 in Phase 2b with NHS and AD in collaboration with Sanofi - STAT6 agent in Phase 1 for TH2 driven inflammation [6][9] - Upcoming program expected to enter the clinic in early 2026 [7] Market Opportunity - **Patient Access**: Out of approximately 160 million patients with common immune inflammatory diseases, only 5 million (3%) currently have access to advanced systemic therapy. Kymera aims to change this by providing oral drugs [9] - **Potential Value**: The company estimates the opportunity could represent hundreds of billions of dollars [9] Product Development Insights - **KT-621 (STAT6 Degrader)**: - Designed to replicate the effects of IL-4 and IL-13 antibodies like dupilumab, with a knockdown efficacy of over 90% [10][11] - Preclinical data suggests it may be more potent than dupilumab, with an IC50 in the low picomolar range [11] - Strong human genetics support the safety and efficacy of targeting STAT6 [12] Clinical Development Strategy - **Phase 1b Study**: Focused on safety and degradation in healthy volunteers, with plans to establish a biomarker profile in atopic dermatitis patients [21][24] - **Future Studies**: Plans to run parallel Phase 2b studies in asthma and atopic dermatitis, with the aim of establishing a robust safety and efficacy profile [34][36] Financial Position - **Capitalization**: The company has $850 million as of December, which is expected to fund operations through mid-2027, allowing for multiple Phase 2b studies across its pipeline [37] Partnership and Collaboration - **Sanofi Partnership**: KT-474 is being developed in collaboration with Sanofi, which is responsible for operational and financial aspects of the ongoing studies [41][42] - **Future Opportunities**: The company is exploring additional indications beyond HS and AD, with a focus on derisked opportunities [43] Additional Programs - **KT-295 (TIG2 Inhibitor)**: Expected to enter Phase 1 study, similar in approach to the STAT6 program, focusing on degradation, safety, and pathway impact [44] Conclusion - Kymera Therapeutics is positioned to leverage its innovative approach in targeted protein degradation to address significant unmet needs in the autoimmune disease market, with a strong pipeline and strategic partnerships to support its development efforts [9][37]

WATERTOWN, Mass., Jan. 30, 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 that the Company will participate in fireside chats at the following upcoming investor events: Guggenheim SMID Cap Biotechnology Conference in New York, NY on February 6 at 10:00 a.m. ET; andOppenheimer 35th Annual Healthcare Life Scienc ...

Core Insights - Kymera Therapeutics, Inc. (KYMR) announced its business goals for 2025, focusing on its immunology pipeline, leading to an 8% increase in stock price and a 47.2% rise over the past year compared to a 16% decline in the industry [1] Pipeline Updates - Kymera is developing KT-621, a first-in-class oral degrader of STAT6, showing dupilumab-like activity and strong safety data in preclinical models [2] - Recruitment is ongoing for a phase I study of KT-621, which has potential applications in various Th2 diseases, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease [3] - Kymera plans to complete the phase I study and report data in Q2 2025, with a phase lb study in atopic dermatitis also set for Q2 2025 and a phase IIb study planned for Q4 2025 [4] Additional Candidates - Kymera is evaluating KT-295, a first-in-class oral degrader of TYK2, with plans to file an investigational new drug application and initiate a phase I study in Q2 2025, expecting data in Q4 2025 [5] - KT-474 (SAR444656), an IRAK4 degrader, is in development for immune-inflammatory diseases, with Sanofi planning to expand ongoing mid-stage studies toward pivotal studies following positive preliminary data [6][7] - Kymera and Sanofi aim to advance KT-474 in phase IIb studies for hidradenitis suppurativa and atopic dermatitis, with primary completion expected in 2026 [8] Future Developments - Kymera plans to announce a new immunology program targeting an undrugged transcription factor in H1 2025, with clinical testing expected in early 2026 [10] - The company decided not to continue developing KT-333 and KT-253 beyond phase I due to a strategic focus on its immunology pipeline [10] Financial Position - As of December 31, 2024, Kymera had an estimated $850 million in cash, sufficient to fund operations into mid-2027 [11]