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Kymera Therapeutics(KYMR) - 2025 FY - Earnings Call Transcript
2025-09-04 14:30
Financial Data and Key Metrics Changes - The company is focused on delivering a new generation of medicines, particularly in immunology, with a significant unmet need in the market for advanced systemic therapies [4][5] - The company has shown that its STAT6 program can match the efficacy of existing biologics like dupilumab, with a focus on oral degraders that can block pathways effectively [6][10] Business Line Data and Key Metrics Changes - The company has shifted its focus to immunology over the past five years, with all recent and preclinical programs targeting this area [4] - The STAT6 program is the most advanced in the pipeline, with two Phase 2b studies planned to start soon [6][10] Market Data and Key Metrics Changes - There are over 100 million patients in the seven major markets suffering from immune inflammatory diseases, with only about 3% having access to advanced therapies [5] - The company aims to address this gap with its oral degraders, which are expected to provide a paradigm shift in treatment options [5] Company Strategy and Development Direction - The company is committed to protecting its franchise by ensuring flawless execution and continuing to develop its drug pipeline [43][44] - The company has a second-generation molecule that is IND ready, which could expand its franchise in the future [44] Management's Comments on Operating Environment and Future Outlook - Management believes that the company has the potential to develop a best-in-class Th2 drug, with clear expectations for the upcoming Phase Ib study [12][13] - The competitive landscape is evolving, but the company feels confident in its unique position and the effectiveness of its STAT6 program [42][46] Other Important Information - The company is exploring opportunities in other therapeutic areas, including Th1 diseases and autoimmune conditions, where there is a lack of effective oral drugs [52] - The management emphasizes the importance of understanding the unique features of their drug and its mechanism in the context of ongoing research [31][32] Q&A Session Summary Question: What are the expectations for the Phase Ib study? - The management expects to demonstrate that STAT6 degradation leads to significant impacts on Th2 cytokines comparable to existing biologics like dupilumab [12][13] Question: How does the company plan to differentiate itself in the competitive landscape? - The company believes it has a strong position due to its advanced programs and the effectiveness of its STAT6 drug, which is difficult for competitors to surpass [42][46] Question: What are the eligibility criteria for the Phase Ib study? - The study will include patients with moderate to severe atopic dermatitis, with specific criteria aligned with previous studies to ensure a relevant patient population [32][33] Question: How does the company view the potential for its second-generation molecule? - The second-generation molecule is seen as both an insurance policy and a potential tool for expanding the franchise, although the focus remains on the current STAT6 program [44][45] Question: What is the company's approach to targeted protein degradation? - The company is focused on matching technology with unmet medical needs and is exploring various avenues for targeted protein degradation, including molecular glues and tissue-selective E3 ligases [56][58]
Kymera Therapeutics, Inc. (KYMR) Presents At Citi's 2025 Biopharma Back To School Conference Transcript
Seeking Alpha· 2025-09-03 17:31
PresentationGeoffrey MeachamManaging Director Here we go. So welcome to the second day of the Citi Biopharma, the Back to School Conference. I'm Geoff Meacham. My team is here with me as well. I'm the senior biopharma analyst. So our next session is Kymera Therapeutics. We're thrilled to have CEO, Nello Mainolfi, President and CEO, sorry; and then Jared Gollob, CMO; Justine from the IR team. Bruce may or may not be here. So maybe, Nello, thanks for joining us, by the way. ...
Kymera Therapeutics (KYMR) Conference Transcript
2025-09-03 15:32
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.
Kymera Therapeutics Appoints Brian Adams as Chief Legal Officer and Corporate Secretary
Globenewswire· 2025-09-03 11:00
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]
Kymera Therapeutics(KYMR) - 2025 Q2 - Earnings Call Transcript
2025-08-11 13:32
Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $11.5 million, entirely from the Sanofi collaboration [26] - R&D expenses were $78.4 million, with adjusted cash R&D spending down 3% from the previous year [27] - G&A expenses totaled $17.6 million, with adjusted cash G&A spending up 6% from the prior quarter [27] - Cash balance at the end of June was $963 million, increasing to approximately $1 billion by July after a follow-on offering [28][29] Business Line Data and Key Metrics Changes - The company reported positive results from the KT621 trial, indicating robust STAT6 degradation in both blood and skin [18][20] - The Phase Ib BROADEN study for moderate to severe atopic dermatitis patients is on track to share data in Q4 2025 [22][23] - The company has selected three doses for upcoming Phase IIb studies, with plans to initiate these studies later this year [11][24] Market Data and Key Metrics Changes - The company aims to address the unmet needs in immunology, particularly for patients lacking access to effective oral therapies [8][17] - The oral IRF5 program is progressing through IND enabling studies, with expectations to advance into Phase I testing in early 2026 [25] Company Strategy and Development Direction - The company is focused on developing oral degrader medicines to transform treatment options in immunology [6][12] - Partnerships with Gilead and Sanofi are expected to yield significant milestones and support the advancement of their drug pipeline [14][30] - The strategy emphasizes combining targeted protein degradation with selected targets to create new classes of medicines [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's progress and the potential impact of their oral therapies on patient lives [6][17] - The company is well-capitalized, with a cash runway extending into 2028, allowing for continued development across multiple programs [16][28] Other Important Information - The company has completed long-term toxicity studies for KT621, showing no adverse events [22] - The company is committed to unveiling one new immunology program per year to expand access to advanced therapies [13] Q&A Session Summary Question: Can you provide insight on the decision to add a second dose in the Phase Ib study? - Management explained that the decision was made to explore an additional dose due to rapid enrollment and to ensure robust data translation from healthy volunteers to patients [34][36] Question: What are the expectations for clinical efficacy measures in the Phase Ib study? - Management indicated that they expect to see a robust biomarker effect similar to dupilumab, particularly focusing on TARC levels [54][56] Question: What safety signals are being monitored in the Phase Ib study? - Management noted that they have not seen any safety signals in previous studies and are encouraged by the results so far [58][59] Question: How is enrollment progressing in the ongoing studies? - Management reported that enrollment has exceeded expectations, driven by patient interest in oral administration [92][94] Question: Can you comment on the differentiation of the CDK2 degrader in the oncology pipeline? - Management highlighted that small molecule inhibitors of CDK2 often do not selectively target CDK2, which is a key differentiation point for their degrader [99]
Kymera Therapeutics(KYMR) - 2025 Q2 - Earnings Call Transcript
2025-08-11 13:30
Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $11.5 million, entirely from the Sanofi collaboration [24] - R&D expenses were $78.4 million, with adjusted cash R&D spending down 3% from the previous year [25] - G&A expenses totaled $17.6 million, with adjusted cash G&A spending up 6% from the prior quarter [25] - Cash balance at the end of June was $963 million, which increased to approximately $1 billion by July, providing a cash runway into 2028 [26][14] Business Line Data and Key Metrics Changes - The company reported positive results from the KT621 trial, indicating robust STAT6 degradation in both blood and skin [16][18] - The Phase Ib BROADEN study for moderate to severe atopic dermatitis patients is on track to share data in Q4 2025 [20] - The company has selected three doses for upcoming Phase IIb studies, with plans to initiate these studies later this year [10][20] Market Data and Key Metrics Changes - The company aims to address the unmet needs in immunology, particularly for patients lacking access to effective oral therapies [6][7] - The oral IRF5 program is progressing through IND enabling studies, with expectations to advance into Phase I testing in early 2026 [22] Company Strategy and Development Direction - The company is focused on developing oral degrader medicines to transform treatment options in immunology [6][15] - Partnerships with Gilead and Sanofi are expected to yield significant milestones, enhancing the company's pipeline and financial position [12][27] - The strategy includes unveiling one new program per year to expand access to oral systemic therapies [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's progress and the potential impact of their oral therapies on patient lives [6][15] - The company is well-capitalized to execute its development strategy and advance multiple programs [28] Other Important Information - The company raised approximately $288 million in a follow-on offering, enhancing its cash position [14] - The collaboration with Gilead includes potential payments of up to $750 million, while the Sanofi collaboration could yield up to $975 million in milestones [27] Q&A Session Summary Question: Can you provide insight on the decision to add a second dose in the Phase Ib study? - The decision was made to explore an additional dose due to rapid enrollment and to confirm robust translation from healthy volunteers to patients [32][34] Question: What are the expectations for clinical efficacy measures in the Phase Ib study? - The primary objective is to show robust STAT6 degradation and a dupilumab-like biomarker effect, with TARC being a key blood biomarker [52][54] Question: How is enrollment progressing in the studies? - Enrollment has exceeded expectations, with oral administration resonating well with patients [90] Question: What safety signals are being monitored in the Phase Ib study? - The company has not seen any safety signals in prior studies and is encouraged by the clean safety profile observed [56][58] Question: Will itch data be included in the upcoming results? - Yes, itch data will be shared as it is an important factor for assessing treatment impact on quality of life [75]
Kymera Therapeutics, Inc. (KYMR) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-08-11 13:11
Company Performance - Kymera Therapeutics reported a quarterly loss of $0.95 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.83, and compared to a loss of $0.58 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $11.48 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 66.7%, and down from $25.65 million in the same quarter last year [2] - Over the last four quarters, Kymera has surpassed consensus EPS estimates only two times and topped revenue estimates just once [2] Market Comparison - Kymera Therapeutics shares have increased by about 1% since the beginning of the year, while the S&P 500 has gained 8.6%, indicating underperformance relative to the broader market [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.92 on revenues of $16.74 million, and for the current fiscal year, it is -$3.39 on revenues of $80.99 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the bottom 41% of over 250 Zacks industries, suggesting that the industry outlook may negatively impact stock performance [8] Estimate Revisions - The estimate revisions trend for Kymera Therapeutics was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6]
Kymera Therapeutics(KYMR) - 2025 Q2 - Earnings Call Presentation
2025-08-11 12:30
Business Overview - Kymera Therapeutics is developing oral degraders with a biologics-like profile to disrupt the immunology market[16] - The company aims to deliver a total of 10 new investigational degrader drugs into the clinic by 2026[12] - Kymera has approximately $1 billion in cash and equivalents, providing a runway into the second half of 2028[15] - The company has dosed over 400 healthy volunteers/patients to date across its clinical pipeline[15] KT-621 (STAT6 degrader) - Phase 1 healthy volunteer trial achieved >90% STAT6 degradation in blood and skin[20] - Single doses of KT-621 achieved >95% mean STAT6 degradation at doses of 75 mg or greater[26] - Multiple daily doses of KT-621 achieved complete STAT6 degradation in blood and skin at doses of ≥50 mg[30, 31] - KT-621 showed robust inhibition of TARC and Eotaxin-3 biomarkers, comparable/superior to published dupilumab data[32] - Phase 1b trial in Atopic Dermatitis (AD) patients is ongoing, with data expected in Q4 2025[37, 38] KT-579 (IRF5 degrader) - KT-579 is a potential first-in-class, potent, selective, oral IRF5 degrader[40, 41] - Phase 1 trial is expected to start in early 2026[43] Financials - Collaboration revenue for the three months ended June 30, 2025 was $25650 thousand, compared to $33576 thousand for the six months ended June 30, 2025[44] - Research and development expenses for the three months ended June 30, 2025 were $78388 thousand, compared to $158643 thousand for the six months ended June 30, 2025[44]
Kymera Therapeutics(KYMR) - 2025 Q2 - Quarterly Report
2025-08-11 11:15
[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) The financial information section details the company's unaudited financial statements, management's analysis of operations and liquidity, market risk exposures, and internal controls [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the six months ended June 30, 2025, show a significant increase in net loss to $142.2 million from $90.6 million in the prior year period, driven by higher research and development expenses. The balance sheet strengthened, with cash, cash equivalents, and marketable securities totaling $963.1 million. The company's financial position was bolstered by a follow-on public offering in June 2025 and a new collaboration agreement with Gilead [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $335,816 | $120,256 | | Marketable securities (current & non-current) | $627,258 | $730,647 | | Total current assets | $728,327 | $510,268 | | Total assets | $1,131,068 | $978,035 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $87,540 | $67,767 | | Total liabilities | $159,588 | $142,416 | | Accumulated deficit | $(896,805) | $(754,610) | | Total stockholders' equity | $971,480 | $835,619 | - Cash, cash equivalents, and marketable securities totaled **$963.1 million** as of June 30, 2025, which the company believes is sufficient to fund operations and capital expenditures for at least the next twelve months[31](index=31&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $11,476 | $25,650 | $33,576 | $35,937 | | Research and development | $78,388 | $59,202 | $158,643 | $108,021 | | General and administrative | $17,645 | $17,373 | $33,916 | $31,747 | | Loss from operations | $(84,557) | $(50,925) | $(158,983) | $(108,756) | | Net loss | $(76,614) | $(42,062) | $(142,195) | $(90,619) | | Net loss per share | $(0.95) | $(0.58) | $(1.77) | $(1.26) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(139,034) | $(82,527) | | Net cash provided by (used in) investing activities | $108,636 | $(314,965) | | Net cash provided by financing activities | $245,984 | $355,168 | | **Net increase (decrease) in cash** | **$215,586** | **$(42,324)** | - Financing activities in H1 2025 were primarily driven by **$237.3 million** in net proceeds from the June 2025 public offering. H1 2024 financing included **$301.4 million** from a January 2024 offering and **$48.7 million** from at-the-market sales[27](index=27&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, financing activities, and collaboration agreements. Key events include a new collaboration with Gilead in June 2025 providing a $40 million upfront payment, and an update on the Sanofi collaboration where Sanofi will advance a next-generation IRAK4 degrader (KT-485) and stop development of KT-474. The company also completed a follow-on public offering in June 2025, raising approximately $250.8 million in gross proceeds before the underwriters' option exercise - In June 2025, the company entered into an exclusive option and license agreement with Gilead to develop CDK2 degraders, receiving a **$40.0 million** non-refundable upfront payment. The company is eligible for an additional **$45.0 million** upon option exercise and up to **$665.0 million** in milestones, plus tiered royalties[52](index=52&type=chunk)[55](index=55&type=chunk) - In June 2025, Sanofi exercised its full participation election to advance the next-generation IRAK4 degrader, KT-485/SAR447971, into clinical testing and intends to stop the development of KT-474. Kymera remains eligible for up to **$975 million** in future milestones[71](index=71&type=chunk) - On June 30, 2025, the company completed a follow-on public offering, raising aggregate gross proceeds of approximately **$250.8 million** before deducting expenses. The underwriters' full option exercise in July 2025 added another **$37.6 million** in gross proceeds[35](index=35&type=chunk)[138](index=138&type=chunk) - In February 2024, the company occupied its new facility and exited its 2019 lease, resulting in an impairment charge of **$4.9 million** in the first quarter of 2024[100](index=100&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on targeted protein degradation (TPD) in immunology, highlighting progress in its STAT6, IRF5, and IRAK4 programs. The analysis of financial results shows a significant year-over-year increase in R&D expenses, primarily due to advancing the STAT6 program. Despite a wider net loss, the company reports a strong liquidity position with a cash runway extending into the second half of 2028, supported by recent financing and collaboration payments [Overview](index=39&type=section&id=Overview) This section provides an overview of the company's strategic focus on targeted protein degradation in immunology and its financial position - The company is a clinical-stage biopharmaceutical firm focused on targeted protein degradation (TPD), primarily for high-value targets in immunology, including STAT6, IRF5, and IRAK4[144](index=144&type=chunk)[146](index=146&type=chunk) - In May 2025, the company made a strategic decision to not advance its TYK2 degrader, KT-295, into clinical development to reallocate resources and extend its cash runway[146](index=146&type=chunk) - As of June 30, 2025, the company had **$963.1 million** in cash, cash equivalents, and marketable securities. Management believes this, plus subsequent proceeds, is sufficient to fund operations into the second half of 2028[153](index=153&type=chunk)[210](index=210&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in collaboration revenue, research and development expenses, and net loss for the reported periods Comparison of Results for the Three Months Ended June 30 (in thousands) | Account | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $11,476 | $25,650 | $(14,174) | | Research and development | $78,388 | $59,202 | $19,186 | | Net loss | $(76,614) | $(42,062) | $(34,552) | Comparison of Results for the Six Months Ended June 30 (in thousands) | Account | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $33,576 | $35,937 | $(2,361) | | Research and development | $158,643 | $108,021 | $50,622 | | Net loss | $(142,195) | $(90,619) | $(51,576) | - The **$50.6 million** increase in R&D expenses for H1 2025 was primarily driven by a **$27.2 million** increase in costs for the STAT6 program, a **$14.8 million** increase in personnel and internal costs, and increased spending on the TYK2 and discovery programs[194](index=194&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, focusing on cash position and cash flow activities - The company had cash, cash equivalents, and marketable securities of **$963.1 million** as of June 30, 2025[198](index=198&type=chunk) - Net cash used in operating activities increased to **$139.0 million** for the first six months of 2025, compared to **$82.5 million** for the same period in 2024, primarily due to a higher net loss[201](index=201&type=chunk)[202](index=202&type=chunk) - Net cash provided by financing activities was **$246.0 million** for the first six months of 2025, mainly from a public offering, compared to **$355.2 million** in the prior year period which included proceeds from an offering and at-the-market sales[201](index=201&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=57&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate changes affecting its cash equivalents and marketable securities, though the impact of a 10% change is not expected to be material. It also has minor exposure to foreign currency exchange rates and notes the potential impact of inflation on operating costs, which is partially offset by higher interest income - The company's main market risk is interest rate sensitivity on its cash and investments, but due to the short-term nature of its portfolio, a **10%** change in rates is not expected to have a material impact[218](index=218&type=chunk) - The company is exposed to inflation, which increases labor, vendor, and clinical trial costs, but notes that higher interest rates have also resulted in higher interest income[220](index=220&type=chunk) [Item 4. Controls and Procedures](index=57&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of June 30, 2025, and concluded they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[222](index=222&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the quarter[223](index=223&type=chunk) [PART II. OTHER INFORMATION](index=58&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, comprehensive risk factors, unregistered equity sales, other significant information, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=58&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - As of the report date, the company is not involved in any litigation or legal proceedings that management believes would likely have a material adverse effect on the business[226](index=226&type=chunk) [Item 1A. Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) The company outlines numerous risks to its business, emphasizing its clinical-stage status, history of significant operating losses, and dependence on raising additional capital. Key risks include the unproven nature of its targeted protein degradation (TPD) approach, potential for clinical trial delays or failures, reliance on third-party collaborators and manufacturers, and the need to obtain and defend intellectual property. It also highlights risks related to competition, commercialization, regulatory approval, and market volatility - The company is a clinical-stage entity with a history of significant operating losses (**$896.8 million** accumulated deficit as of June 30, 2025) and expects to incur continued losses for the foreseeable future[228](index=228&type=chunk)[229](index=229&type=chunk) - The company's drug discovery approach, targeted protein degradation (TPD), is novel and unproven, making it difficult to predict the time, cost, and likelihood of successfully developing any products[247](index=247&type=chunk) - The business is heavily dependent on third parties for conducting clinical trials (CROs), manufacturing products (CMOs), and advancing certain programs through collaborations (e.g., Sanofi and Gilead)[345](index=345&type=chunk)[356](index=356&type=chunk) - The company faces substantial competition from other firms developing protein degraders and traditional therapies, many of which have greater financial and technical resources[336](index=336&type=chunk)[337](index=337&type=chunk)[338](index=338&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=145&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no sales of unregistered equity securities during the quarter ended June 30, 2025 - There were no sales of unregistered securities during the three months ended June 30, 2025[466](index=466&type=chunk) [Item 5. Other Information](index=145&type=section&id=Item%205.%20Other%20Information) The company discloses that Jared Gollob, Chief Medical Officer, adopted a Rule 10b5-1 trading plan on June 2, 2025, for the potential sale of up to 111,997 shares of common stock through December 31, 2026 - On June 2, 2025, Chief Medical Officer Jared Gollob adopted a Rule 10b5-1 trading plan covering the exercise of vested stock options and sale of up to **111,997** shares of common stock[468](index=468&type=chunk) [Item 6. Exhibits](index=146&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the form of Pre-Funded Warrant, a Registration Rights Agreement, a letter agreement with Genzyme, the amended director compensation policy, and officer certifications
Kymera Therapeutics(KYMR) - 2025 Q2 - Quarterly Results
2025-08-11 11:10
[Kymera Therapeutics Q2 2025 Business and Financial Highlights](index=1&type=section&id=Kymera%20Therapeutics%20Q2%202025%20Business%20and%20Financial%20Highlights) The company reports significant pipeline advancements, a new strategic partnership, and a strengthened financial position despite a quarterly net loss [Business Highlights and Pipeline Update](index=1&type=section&id=Business%20Highlights%20and%20Pipeline%20Update) The company advanced its immunology pipeline with positive KT-621 data, progressed KT-579, and secured a strategic partnership and new funding - The company is well-capitalized with approximately **$1 billion in cash** as of July 31, 2025, extending its financial runway into the **second half of 2028**[1](index=1&type=chunk)[2](index=2&type=chunk)[8](index=8&type=chunk) - Entered a strategic partnership with Gilead to develop novel oral molecular glue CDK2 degraders, with potential payments up to **$750 million**[1](index=1&type=chunk)[9](index=9&type=chunk) - Sanofi has prioritized Kymera's second-generation IRAK4 degrader, KT-485, for advancement into Phase 1 clinical studies in 2026[2](index=2&type=chunk)[9](index=9&type=chunk) [STAT6 Degrader Program (KT-621)](index=2&type=section&id=STAT6%20Degrader%20Program%20(KT-621)) The oral STAT6 degrader KT-621 demonstrated a positive Phase 1 profile, with plans to initiate Phase 2b trials in late 2025 and early 2026 - Phase 1 healthy volunteer data surpassed the target product profile, demonstrating **rapid, deep, and prolonged STAT6 degradation**, with complete degradation achieved in both blood and skin at doses ≥50 mg[1](index=1&type=chunk)[3](index=3&type=chunk) - KT-621 showed an impact on Th2 biomarkers comparable or superior to dupilumab, with median **TARC reduction up to 37%** and median **Eotaxin-3 reduction up to 63%**[3](index=3&type=chunk) Upcoming Milestones for KT-621 | Milestone | Indication | Expected Timing | | :--- | :--- | :--- | | Phase 1b (BroADen) Data | Atopic Dermatitis (AD) | 4Q 2025 | | Phase 2b Trial Initiation | Atopic Dermatitis (AD) | 4Q 2025 | | Phase 2b Trial Initiation | Asthma | 1Q 2026 | [IRF5 Degrader Program (KT-579)](index=3&type=section&id=IRF5%20Degrader%20Program%20(KT-579)) The first-in-class oral IRF5 degrader KT-579 is advancing through IND-enabling studies, with a Phase 1 trial anticipated in early 2026 - KT-579 is a **first-in-class oral degrader of IRF5**, a genetically validated transcription factor with potential utility in diseases such as lupus, Sjögren's, inflammatory bowel disease (IBD), and rheumatoid arthritis (RA)[4](index=4&type=chunk) - The program is currently in IND-enabling studies, with a **Phase 1 clinical trial anticipated to commence in early 2026**[1](index=1&type=chunk)[6](index=6&type=chunk) - New preclinical data from lupus and RA animal models will be presented at the American College of Rheumatology (ACR) Annual Meeting in October 2025[6](index=6&type=chunk) [Collaboration and Corporate Updates](index=4&type=section&id=Collaboration%20and%20Corporate%20Updates) The company strengthened its financial position through a new Gilead partnership, a Sanofi milestone payment, and a successful equity offering - Entered an exclusive option and license agreement with Gilead for a CDK2 molecular glue degrader program, with Kymera eligible for up to **$750 million in total payments** plus tiered royalties[9](index=9&type=chunk) - Sanofi prioritized the second-generation IRAK4 degrader KT-485 for Phase 1 testing, triggering a **$20 million milestone payment** to Kymera in Q2 2025, while the first-generation degrader, KT-474, will not be advanced[9](index=9&type=chunk) - Completed an underwritten equity offering with total gross proceeds of approximately **$288 million**, strengthening the company's balance sheet[8](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=5&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported lower Q2 2025 revenues and a wider net loss driven by increased R&D expenses, while maintaining a strong cash position Q2 2025 Financial Highlights (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenues | $11.5M | $25.7M | -55.3% | | R&D Expenses | $78.4M | $59.2M | +32.4% | | G&A Expenses | $17.6M | $17.4M | +1.1% | | Net Loss | ($76.6M) | ($42.1M) | +81.9% | | Net Loss Per Share | ($0.95) | ($0.58) | +63.8% | - The increase in R&D expenses was primarily driven by investments in the **STAT6 program**, platform and discovery programs, and organizational growth[11](index=11&type=chunk) - As of June 30, 2025, the company had **$963.1 million** in cash, cash equivalents, and investments, a balance that grew to approximately **$1 billion** by July 31, 2025, after recent financing activities[14](index=14&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section presents the unaudited consolidated Balance Sheet and Statement of Operations for the period ended June 30, 2025 [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet shows total assets grew to $1.13 billion as of June 30, 2025, primarily due to an increase in cash and marketable securities Consolidated Balance Sheets (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and marketable securities | $963,074 | $850,903 | | Total assets | $1,131,068 | $978,035 | | **Liabilities and Stockholders' Equity** | | | | Total liabilities | $159,588 | $142,416 | | Total stockholders' equity | $971,480 | $835,619 | | Total liabilities and stockholders' equity | $1,131,068 | $978,035 | [Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statement of operations details a net loss of $76.6 million for the three months and $142.2 million for the six months ended June 30, 2025 Consolidated Statements of Operations (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration Revenue | $11,476 | $25,650 | | Total operating expenses | $96,033 | $76,575 | | Loss from operations | ($84,557) | ($50,925) | | Net loss | ($76,614) | ($42,062) | | Net loss per share, basic and diluted | ($0.95) | ($0.58) |