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Kymera Therapeutics(KYMR) - 2022 Q2 - Earnings Call Transcript
2022-08-10 06:11
Financial Data and Key Metrics Changes - The company recognized $11.5 million in revenue for the quarter, reflecting revenue from collaborations with Sanofi and Vertex [32] - Operating expenses for R&D were $41.3 million, with adjusted cash R&D spending increasing by 14% compared to the previous quarter [33] - The company ended the quarter with approximately $482 million in cash, providing a runway into 2025 based on current spending levels [34] Business Line Data and Key Metrics Changes - The company has three first-in-class TPD assets in clinical studies, with KT-474, KT-333, and KT-413 progressing well [9][22] - KT-474 has commenced patient dosing in Part C of its Phase I trial, targeting immune inflammatory diseases [15] - The oncology programs, including STAT3, IRAKIMiD, and MDM2, are all advancing, with ongoing patient enrollment and dosing [22][27][30] Market Data and Key Metrics Changes - The company is collaborating with Sanofi on the development of degrader candidates targeting IRAK4, expanding its market reach beyond oncology [13] - The focus on hematological malignancies and solid tumors with the STAT3 program indicates a strategic move to address multiple cancer types [22] Company Strategy and Development Direction - The company aims to build a best-in-class fully integrated degrader medicine company, with ambitions to expand the druggable proteome [5][9] - Plans include advancing at least one new IND per year and maintaining productive collaborations with partners like Sanofi and Vertex [9] - The company is focused on generating key clinical insights and data sets in the second half of the year, particularly for KT-474 and oncology programs [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy profiles of their drug candidates, emphasizing the importance of translating preclinical findings to clinical settings [44][46] - The company is optimistic about the potential of its pipeline to improve patient lives and is preparing for significant data releases in the near future [36][38] Other Important Information - The company has multiple patient data sets expected by year-end, which will inform decisions on advancing programs into Phase II studies [10] - The management highlighted the importance of understanding the pharmacokinetics and pharmacodynamics of their drugs to mitigate risks in clinical development [47] Q&A Session Summary Question: Additional findings on QT effect and therapeutic window for KT-474 and KT-413 - Management discussed the non-adverse QT finding, indicating it is self-limiting and does not impact the drug's clinical potential [48][56] - Confidence was expressed in achieving the required IRAK4 degradation within a feasible window for KT-413, with plans to focus on MYD88 mutant patients in future studies [43][51] Question: Expectations for QT prolongation and patient selection - Management stated that a QT prolongation of 10 to 20 milliseconds would not require monitoring, while excursions beyond 40 milliseconds might [82] - Patients with prolonged QT at baseline or on other QT-prolonging drugs would be excluded from the study [60][80] Question: Development plan for KT-253 and molecular glue programs - The company plans to initiate first-in-human studies for KT-253 towards the end of the year, with a focus on AML and other solid tumors [86][87] - Molecular glue programs are still in the discovery stage, with updates expected closer to clinical readiness [88] Question: Dosing and exploratory responses in Part C study for KT-474 - The 75 mg dose was selected to achieve maximum pharmacology in a fed state, with expectations for similar activity to the 100 mg dose in fasting [71][72] - Management noted that the kinetics of IRAK4 degradation may differ between atopic dermatitis and hidradenitis suppurativa, but both will be evaluated in the study [75]
Kymera Therapeutics(KYMR) - 2022 Q2 - Quarterly Report
2022-08-09 11:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39460 KYMERA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Del ...
Kymera Therapeutics(KYMR) - 2022 Q1 - Quarterly Report
2022-05-03 11:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39460 KYMERA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) De ...
Kymera Therapeutics(KYMR) - 2021 Q4 - Annual Report
2022-02-24 12:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39460 KYMERA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation ...
Kymera Therapeutics(KYMR) - 2021 Q3 - Quarterly Report
2021-11-10 12:21
Commission File Number: 001-39460 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ KYMERA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter ...
Kymera Therapeutics(KYMR) - 2021 Q2 - Quarterly Report
2021-08-06 11:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39460 KYMERA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Del ...
Kymera Therapeutics (KYMR) Presents At Ligase Targeting Drug Development Summit - Slideshow
2021-05-28 19:33
May 25-27, 2021 Ligase Targeting DrugDevelopment Seize the Therapeutic Value of Ubiquitin Ligases Drugging Tissue-Restricted E3 Ligases | --- | --- | --- | --- | --- | |-------|-------|-------|-------|---------------------------------------------------------------| | | | | | | | | | | | Chris De Savi, PhD | | | | | | VP, Head of Drug Discovery | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | INVENTING NEW MEDICINES | | | | | | W I T H T A R G E T E D P R O T E I N D E G R ...
Kymera Therapeutics(KYMR) - 2021 Q1 - Quarterly Report
2021-05-06 11:15
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Collaboration revenue significantly increased due to the Sanofi agreement, but rising R&D expenses led to a **$13.1 million** net loss, despite a strong **$435.2 million** cash position Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $53,098 | $31,004 | | Marketable securities | $382,078 | $427,729 | | Total current assets | $340,791 | $302,339 | | Total assets | $464,552 | $487,175 | | **Liabilities & Stockholders' Equity** | | | | Deferred revenue (current & non-current) | $152,566 | $170,390 | | Total liabilities | $189,305 | $203,287 | | Total stockholders' equity | $275,247 | $283,888 | Q1 2021 vs Q1 2020 Statement of Operations (in thousands, except per share data) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Collaboration Revenue | $18,702 | $3,428 | | Research and development | $25,962 | $12,116 | | General and administrative | $5,909 | $2,559 | | Total operating expenses | $31,871 | $14,675 | | Loss from operations | ($13,169) | ($11,247) | | Net loss | ($13,075) | ($10,932) | | Net loss per share | ($0.29) | ($10.23) | Q1 2021 vs Q1 2020 Cash Flows (in thousands) | Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($22,823) | ($12,057) | | Net cash provided by (used in) investing activities | $44,323 | ($37,403) | | Net cash provided by financing activities | $595 | $93,120 | - The company is a biopharmaceutical firm focused on targeted protein degradation, has not yet generated product revenue, and has a history of net losses, with an accumulated deficit of **$141.8 million** as of March 31, 2021[31](index=31&type=chunk)[32](index=32&type=chunk) - Management believes its cash, cash equivalents, and marketable securities of **$435.2 million** as of March 31, 2021, are **sufficient** to fund operations and capital expenditures for at least the next twelve months[33](index=33&type=chunk) - The Sanofi collaboration, initiated in July 2020, included a **$150.0 million** upfront payment. The company is eligible for up to **$1.48 billion** in development milestones and **$700.0 million** in commercial milestones. In Q1 2021, **$11.6 million** in revenue was recognized from this agreement[53](index=53&type=chunk)[58](index=58&type=chunk)[67](index=67&type=chunk) - The Vertex collaboration, initiated in May 2019, included a **$50.0 million** upfront payment and a **$5.9 million** premium on a stock purchase. The company is eligible for up to **$170.0 million** in payments per target. In Q1 2021, **$7.1 million** in revenue was recognized from this agreement[70](index=70&type=chunk)[71](index=71&type=chunk)[79](index=79&type=chunk) - Total equity-based compensation expense was **$3.2 million** for Q1 2021, a significant increase from **$0.4 million** in Q1 2020[118](index=118&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical-stage Pegasus™ platform, key programs, a partial clinical hold on KT-474, and **sufficient** cash of **$435.2 million** to fund operations into 2025 - The company is a clinical-stage biopharmaceutical company with key programs in IRAK4, IRAKIMiD, and STAT3, utilizing its proprietary Pegasus™ targeted protein degradation platform[126](index=126&type=chunk) - The company initiated a Phase 1 trial for its IRAK4 degrader, KT-474, in February 2021. However, the multiple ascending dose (MAD) portion of the trial is on a partial clinical hold by the FDA pending review of data from the single ascending dose (SAD) portion[126](index=126&type=chunk) - As of March 31, 2021, the company had **$435.2 million** in cash, cash equivalents, and marketable securities, which is expected to fund operating expenses and capital expenditure requirements into 2025[133](index=133&type=chunk)[167](index=167&type=chunk) - The COVID-19 pandemic is noted as a risk, potentially impacting clinical trial timelines and business operations, though specific significant disruptions to date were limited to a minor delay in API starting materials[133](index=133&type=chunk)[134](index=134&type=chunk)[293](index=293&type=chunk) Results of Operations Q1 2021 collaboration revenue increased by **$15.3 million** to **$18.7 million**, while R&D and G&A expenses also significantly rose due to program advancement and public company operations Comparison of Operating Results (in thousands) | Item | Q1 2021 | Q1 2020 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $18,702 | $3,428 | $15,274 | | Research & Development | $25,962 | $12,116 | $13,846 | | General & Administrative | $5,909 | $2,559 | $3,350 | | Loss from Operations | ($13,169) | ($11,247) | ($1,922) | - The increase in R&D expenses was primarily due to a **$3.9 million** increase in direct expenses for IRAK4, IRAKIMiD, and STAT3 programs, a **$5.3 million** increase in platform and exploratory program investment, and a **$4.7 million** increase in personnel and related costs[154](index=154&type=chunk) Liquidity and Capital Resources The company has **$435.2 million** in cash, **sufficient** to fund operations into 2025, but anticipates needing additional capital for future clinical development - As of March 31, 2021, the company had cash, cash equivalents, and marketable securities of **$435.2 million**[157](index=157&type=chunk) - Cash used in operating activities was **$22.8 million** in Q1 2021, compared to **$12.1 million** in Q1 2020[158](index=158&type=chunk)[159](index=159&type=chunk) - The company expects its existing cash to fund operations and capital expenditures into 2025, but anticipates needing substantial additional funds to complete clinical development and commercialization[167](index=167&type=chunk)[168](index=168&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate changes on its **$435.2 million** portfolio, but management deems exposure to interest rate, foreign currency, and inflation risks minimal - The company's primary market risk is interest rate changes on its **$435.2 million** portfolio of cash and marketable securities[176](index=176&type=chunk) - Management believes the company does not have material exposure to interest rate risk, foreign currency risk, or inflation[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were **effective** as of March 31, 2021, with **no material changes** to internal control over financial reporting - Management concluded that as of March 31, 2021, the company's disclosure controls and procedures were **effective** at the reasonable assurance level[180](index=180&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the first quarter of 2021[181](index=181&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings[184](index=184&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces extensive risks including historical losses, need for future funding, unproven platform, potential clinical trial failures like the KT-474 partial hold, and intense competition - The company has a limited operating history, has never generated revenue from drug sales, and has incurred significant operating losses, with an accumulated deficit of **$141.8 million** as of March 31, 2021[186](index=186&type=chunk)[188](index=188&type=chunk) - The company's targeted protein degradation (TPD) approach is novel and unproven, making it difficult to predict development time, cost, and likelihood of success. No TPD product candidates have been approved in the US or Europe[199](index=199&type=chunk) - The company's IRAK4 program (KT-474) is on partial clinical hold for the multiple ascending dose (MAD) portion of its Phase 1 trial, pending FDA review of data from the single ascending dose (SAD) portion[204](index=204&type=chunk) - The company faces substantial competition from other companies developing protein degraders, such as Arvinas, Inc. and C4 Therapeutics, Inc., as well as from companies developing traditional therapies for the same indications[279](index=279&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported **no unregistered sales** of equity securities during the period - **None**[390](index=390&type=chunk) [Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including officer certifications and XBRL data files - Exhibits filed include CEO and CFO certifications under Sarbanes-Oxley Sections 302 and 906, and XBRL interactive data files[394](index=394&type=chunk)
Kymera Therapeutics (KYMR) Presents At AACR Virtual Meeting 2021 - Slideshow
2021-04-12 19:55
Mechanisms Underlying Synergistic Activity of KT-413, a Targeted Degrader of IRAK4 and IMiD Substrates in Hematopoietic Cancers Christine Klaus, Scott Rusin, Samya Bhaduri, Dirk Walther, Kirti Sharma, Michele Mayo, Alice McDonald, Matthew Weiss, Duncan Walker, Rahul Karnik Poster # LB118 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. These statements include ...
Kymera Therapeutics (KYMR) Investor Presentation - Slideshow
2021-03-19 18:56
Kymera Therapeutics Overview - Kymera Therapeutics is building a fully integrated degrader medicines company focused on targeted protein degradation (TPD)[7] - The company's strategy focuses on undrugged targets and clinical indications with high unmet medical needs and franchise potential[7] - Kymera expects 3 INDs and clinical initiations by the end of 2021[8] - As of Q4 2020, Kymera had a cash balance of $459 million, which is expected to fund operational plans into 2025[8,98] IRAK4 Program (KT-474) - KT-474 is a potent, selective, and orally active IRAK4 degrader with potential across various immune-inflammatory diseases[50] - In preclinical studies, KT-474 demonstrated almost complete knockdown across multiple tissues at multiple doses and was well-tolerated up to 600 mg/kg in rodents and 100 mg/kg in non-rodents[43] - A non-interventional study in HS patients showed higher IRAK4 levels in lesional and peri-lesional skin compared to non-lesional skin[45] - Ex vivo incubation of HS blood with KT-474 reduced IRAK4 levels across all PBMC subsets, while an IRAK4 kinase inhibitor increased IRAK4 levels in T and NK cells[47] - Phase 1 SAD portion initiated in Q1 2021, with MAD enrollment expected in 2H 2021 and proof-of-biology data expected in Q4 2021[32,48] IRAKIMiD Program (KT-413) - KT-413 is an IRAKIMiD degrader targeting IRAK4, Ikaros, and Aiolos, with potential as a precision medicine in MYD88-mutant DLBCL[51,53] - Preclinical data shows degradation of IRAK4, Ikaros, and Aiolos correlates to cell killing, with IRAK4 DC50 = 8 nM and Ikaros/Aiolos DC50 = 2 nM[58,60] - KT-413 demonstrated strong tumor regressions in preclinical models with intermittent dosing, with >90% maximum degradation of IRAK4 and Ikaros observed at 3 mg/kg dosing[63,64] - IND submission and Phase 1 clinical trial initiation in r/r B cell lymphomas is expected in 2H 2021, with proof-of-biology data expected in 2022[52,71] STAT3 Program (KT-333) - Kymera is developing STAT3 degraders for liquid and solid tumors, as well as autoimmune/fibrotic diseases[74] - Preclinical data demonstrates highly specific degradation of STAT3, with STAT3 being the only protein to be degraded with statistical significance[78] - STAT3 degrader treatment led to >95% decrease of STAT3 levels with DC50 of 15nM and 86 nM in two STAT3-dependent cell lines[79] - Development candidate nomination expected in Q1 2021, with IND submission and Phase 1 clinical trial initiation expected in Q4 2021[74,95]