KT-333 demonstrated initial clinical proof of concept across multiple hematological malignancies, including complete responses in two patients with Hodgkin's lymphoma WATERTOWN, Mass., June 14, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new clinical data from its ongoing KT-333 Phase 1 trial. KT333, a first-in-class, potent, highly select ...

WATERTOWN, Mass., May 29, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that the Company will participate in fireside chats at the following upcoming investor events: Jefferies 2024 Global Healthcare Conference in New York, NY on June 5 at 11:30 a.m. ET; and Goldman Sachs 45th Annual Global Healthcare Conference in Miami, FL on June 11 at ...

Abstract released today highlights safety, pharmacodynamic and clinical response data with additional data to be presented in a poster session on June 1, 2024 WATERTOWN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced new clinical data for KT-253, a first-in-class MDM2 degrader, from its ongoing Phase 1 dose escalation trial ...

KT-621 expected to start Phase 1 in the second half of 2024, with Phase 1 data in the first half of 2025 Additional KT-621 preclinical data was also featured in a poster presentation at Digestive Disease Week The company previously presented data showing its first-in-class oral STAT6 degrader, KT-621, was exquisitely selective for STAT6 over other STATs and fully blocked IL-4/IL-13 functions in key human TH2 cellular assays with picomolar potency that was superior to dupilumab. In addition, at low daily ora ...

Core Insights - Kymera Therapeutics is advancing KT-333, a first-in-class targeted protein degrader of STAT3, with promising Phase 1 clinical data to be presented at the European Hematology Association Annual Meeting in June 2024 [1][4] Group 1: Clinical Data and Results - The Phase 1 study of KT-333 involved 39 patients across six dose levels, with a mean of 8.7 doses administered [3] - Significant clinical responses were observed in specific patient populations, including two complete responses in classic Hodgkin's lymphoma (cHL) patients and three partial responses in cutaneous T-cell lymphoma (CTCL) patients [4] - KT-333 achieved up to 97.5% degradation of STAT3 in peripheral blood mononuclear cells, indicating effective pathway inhibition [4] Group 2: Safety and Tolerability - KT-333 was generally well-tolerated, with common adverse events including stomatitis, nausea, ALT increase, constipation, and fatigue [4] - Two dose-limiting toxicities (DLTs) were reported at the highest dose level, including Grade 3 stomatitis and arthralgia [4] Group 3: Future Development and Expectations - The ongoing Phase 1 study is expected to provide additional clinical data to inform the next development steps for KT-333 later in 2024 [3][5] - The company anticipates sharing further updates on KT-333's clinical program across various indications later this year [2]

Financial Data and Key Metrics Changes - Revenue for Q1 2024 was $10.3 million, entirely from the collaboration with Sanofi, with a cash balance of $745 million at the end of the quarter [34][35] - R&D expenses for the quarter were $48.8 million, with adjusted cash R&D spend decreasing by 10% from the previous quarter to $42.7 million [20][35] - General and administrative expenses were $14.4 million, reflecting a 1% decrease from the previous quarter [35] Business Line Data and Key Metrics Changes - The IRAK4 program is progressing in two Phase 2 trials for hidradenitis suppurativa and atopic dermatitis, with top-line data expected in the first half of 2025 [27] - KT-621 is on track to enter Phase 1 testing in the second half of 2024, focusing on allergic diseases [17] - KT-294 demonstrated sustained TYK2 knockdown in vivo, indicating potential for multiple immune-inflammatory diseases [18] Market Data and Key Metrics Changes - The company aims to address the market dominated by injectable biologics by developing oral small molecule degrader medicines with biologics-like activity [5][6] - The focus is on expanding patient access in markets currently limited by injectable agents [6] Company Strategy and Development Direction - The company is committed to building a global commercial stage medicines company by transitioning from early to mid-late development across its pipeline [9] - There is a focus on developing oral agents that are well-tolerated and do not require extensive monitoring, differentiating from existing therapies [45][92] - The strategy includes prioritizing larger indications where injectable therapies have low penetration [82] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their oral degrader programs to transform treatment paradigms in immunology and oncology [9][27] - The company is focused on executing its clinical development plans and expects significant data readouts in 2024 and 2025 [19][35] Other Important Information - The company has received approximately $300 million in net proceeds from an equity offering, providing a runway into the first half of 2027 [35] - The company plans to present additional data at upcoming medical meetings, including ASCO and EHA [31][33] Q&A Session Summary Question: Insights on MDM2 data and ASCO presentation - Management discussed the importance of presenting updated data to connect with the medical and investor community, highlighting progress in both arms of the trial [38] Question: Thoughts on recent RAINBOW data and its impact - Management noted that while JAK inhibitors are effective, their focus remains on using protein degradation to achieve better efficacy and safety profiles [44] Question: Updates on KT-333 and EHA presentation - The aim for the EHA presentation is to provide further data on safety and pharmacologic effects, with a final dataset expected later in 2024 [56] Question: Development of STAT6 degrader and collaboration with Sanofi - Management reiterated their commitment to developing their immunology pipeline independently, despite interest from other parties [70] Question: Factors for partnership considerations in oncology - Management indicated that partnerships would be evaluated based on mutual benefits and strategic alignment, rather than solely financial reasons [110]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited financial statements, showing total assets increased to **$868.3 million** and a net loss of **$48.6 million** for Q1 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $93,510 | $109,966 | | Marketable securities | $651,424 | $326,349 | | Total assets | $868,251 | $575,759 | | Total liabilities | $157,048 | $180,788 | | Total stockholders' equity | $711,203 | $394,971 | Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Collaboration Revenue | $10,287 | $9,466 | | Research and development | $48,819 | $42,227 | | General and administrative | $14,374 | $12,565 | | Impairment of long-lived assets | $4,925 | $— | | Loss from operations | $(57,831) | $(45,326) | | Net loss | $(48,557) | $(40,928) | | Net loss per share, basic and diluted | $(0.69) | $(0.70) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(39,591) | $(43,968) | | Net cash (used in) provided by investing activities | $(330,607) | $24,584 | | Net cash provided by financing activities | $353,756 | $1,159 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail a **$316.2 million** follow-on offering, **$10.3 million** collaboration revenue, a **$4.9 million** lease impairment, and **$12.0 million** in equity-based compensation - In January 2024, the company completed a follow-on offering, issuing common stock and pre-funded warrants, which generated aggregate gross proceeds of approximately **$316.2 million**[33](index=33&type=chunk) - The company recognized **$10.3 million** in revenue under the Sanofi Agreement in Q1 2024. As of March 31, 2024, the remaining deferred revenue from this collaboration was **$46.4 million**[62](index=62&type=chunk)[65](index=65&type=chunk) - Upon occupying a new lease facility in February 2024, the company exited its 2019 lease facility, resulting in an impairment charge of **$4.9 million** in the first quarter of 2024[83](index=83&type=chunk) Equity-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $6,083 | $4,729 | | General and administrative | $5,885 | $4,656 | | **Total** | **$11,968** | **$9,385** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's TPD platform and clinical programs, noting a **$48.6 million** net loss and **$744.9 million** in liquidity expected to fund operations into H1 2027 [Overview](index=19&type=section&id=Overview) Kymera develops novel small molecule therapeutics via its Pegasus™ TPD platform, with clinical programs in immuno-inflammatory diseases and oncology, supported by **$744.9 million** in liquidity - The company's clinical-stage programs are IRAK4, STAT3, and MDM2, addressing immuno-inflammatory diseases and oncology. Preclinical programs targeting STAT6 and TYK2 are currently in IND-enabling studies[108](index=108&type=chunk) - The IRAK4 degrader, KT-474, is in Phase 2 clinical trials conducted by partner Sanofi for hidradenitis suppurativa (HS) and atopic dermatitis (AD)[109](index=109&type=chunk) - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities of **$744.9 million**, which is expected to fund operations into the first half of 2027[116](index=116&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2024 saw **$10.3 million** in collaboration revenue, increased R&D expenses to **$48.8 million**, a **$4.9 million** impairment charge, and a widened net loss of **$48.6 million** Collaboration Revenue (in millions) | Source | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Sanofi | $10.3 | $7.7 | | Vertex | $0.0 | $1.8 | | **Total** | **$10.3** | **$9.5** | Research & Development Expenses (in thousands) | Category | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | External R&D Costs | $20,696 | $19,618 | $1,078 | | Internal R&D Costs | $28,123 | $22,609 | $5,514 | | **Total R&D Expenses** | **$48,819** | **$42,227** | **$6,592** | - The **$6.6 million** increase in R&D expenses was primarily due to a **$5.5 million** increase in personnel, stock-based compensation, and occupancy costs, and a **$2.6 million** increase in costs for the STAT6 and discovery programs[140](index=140&type=chunk) - An impairment charge of **$4.9 million** was recognized in Q1 2024 due to the occupancy of the new 2021 lease facility and the exit from the 2019 lease facility[142](index=142&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity with **$744.9 million** in cash, primarily from a **$353.8 million** financing, expected to fund operations into H1 2027 - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities of **$744.9 million**[145](index=145&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2024 | | :--- | :--- | | Cash used in operating activities | $(39,591) | | Cash used in investing activities | $(330,607) | | Cash provided by financing activities | $353,756 | - Net cash from financing activities of **$353.8 million** included **$301.4 million** from a public offering and **$48.7 million** from an at-the-market sales agreement[151](index=151&type=chunk) - The company expects its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements into the first half of 2027[155](index=155&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks include interest rate sensitivity on investments and foreign currency fluctuations, with inflation also impacting costs - The company's main market risk exposures are interest rate sensitivity on its investment portfolio and foreign currency exchange risk from contracts with vendors in Asia and Europe[161](index=161&type=chunk)[162](index=162&type=chunk) - Inflation is identified as a risk that increases the cost of labor, third-party vendors, and clinical trials[163](index=163&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024[165](index=165&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[166](index=166&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any litigation or legal proceedings expected to have a material adverse effect on its business[169](index=169&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including limited operating history, substantial losses, unproven TPD platform, regulatory hurdles, and intense competition [Financial and Operational Risks](index=30&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) Significant financial risks include limited operating history, **$579.3 million** accumulated deficit, and the need for substantial additional funding to avoid program delays - The company has a limited operating history, has not generated any revenue from drug sales, and may never become profitable[171](index=171&type=chunk) - The company has incurred significant operating losses, with an accumulated deficit of **$579.3 million** as of March 31, 2024, and expects these losses to continue[172](index=172&type=chunk) - The company will need to raise substantial additional funding; failure to do so could force it to delay, scale back, or discontinue product development programs[174](index=174&type=chunk) [Drug Development and Regulatory Risks](index=34&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) Drug development faces high uncertainty due to its novel TPD platform, early-stage programs, potential side effects, and complex, uncertain regulatory approval processes - The company's approach using its Pegasus™ TPD platform is novel and unproven, making it difficult to predict the time, cost, and likelihood of successfully developing any products[192](index=192&type=chunk) - The company's most advanced programs (IRAK4, STAT3, MDM2) are in early clinical development, and their success is not guaranteed[187](index=187&type=chunk) - Positive results from early preclinical and clinical trials are not necessarily predictive of the results of later-stage trials[207](index=207&type=chunk) - Product candidates may cause undesirable side effects that could delay or prevent regulatory approval or limit their commercial profile[214](index=214&type=chunk) [Commercialization and Competition Risks](index=53&type=section&id=Risks%20Related%20to%20Commercialization) Commercialization risks include achieving market acceptance, intense competition from better-resourced companies, and the lack of internal sales and marketing infrastructure - Even if approved, the company's product candidates may not achieve broad market acceptance, which would limit revenue[278](index=278&type=chunk) - The company faces substantial competition from other companies developing protein degraders and traditional therapies, many of which have greater financial resources and expertise[280](index=280&type=chunk)[282](index=282&type=chunk)[283](index=283&type=chunk) - The company has no experience in sales, marketing, or distribution and will need to build these capabilities or partner with third parties to commercialize its products[287](index=287&type=chunk) [Reliance on Third Parties and Intellectual Property Risks](index=55&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Heavy reliance on third parties for clinical trials and manufacturing, coupled with the need for robust intellectual property protection, poses significant operational and legal risks - The company relies on third parties like CROs to conduct its clinical trials, and if these parties do not perform successfully, its development programs could be substantially harmed[290](index=290&type=chunk)[291](index=291&type=chunk) - The company depends on a limited number of suppliers for the API and drug product used in its candidates, and the loss of any could significantly harm the business[296](index=296&type=chunk) - The company's success depends on its ability to obtain and maintain patent and other intellectual property protection, but the scope of such protection may not be sufficiently broad[308](index=308&type=chunk)[309](index=309&type=chunk) - The company may become a party to lawsuits to protect or enforce its intellectual property rights, which could be expensive, time-consuming, and unsuccessful[344](index=344&type=chunk) [Item 2. 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 sales of unregistered equity securities during the three months ended March 31, 2024 - During the quarter ended March 31, 2024, the company did not have any sales of unregistered securities[402](index=402&type=chunk) [Item 5. Other Information](index=77&type=section&id=Item%205.%20Other%20Information) Director Joanna Horobin adopted a Rule 10b5-1 trading plan on March 8, 2024, for the potential sale of up to **34,000** shares - Director Joanna Horobin adopted a Rule 10b5-1 trading plan on March 8, 2024, for the potential sale of up to **34,000** shares of common stock, with the plan expiring on July 1, 2025[403](index=403&type=chunk) [Item 6. Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including compensation policy, officer certifications, and XBRL documents - The report includes several exhibits, such as the Amended and Restated Non-Employee Director Compensation Policy, CEO/CFO certifications, and XBRL data files[405](index=405&type=chunk)

Exhibit 99.1 Kymera Therapeutics Announces First Quarter 2024 Financial Results and Provides a Business Update KT-474/SAR444656 (IRAK4) Phase 2 clinical trials ongoing in HS and AD with data expected in the first half of 2025 KT-621 (STAT6) expected to start Phase 1 in the second half of 2024 and KT-294 (TYK2) expected to start Phase 1 in the first half of 2025, both with Phase 1 data in 2025 KT-253 (MDM2) and KT-333 (STAT3) Phase 1 dose escalation studies ongoing with clinical data updates at ASCO and EHA, ...

KT-474/SAR444656 (IRAK4) Phase 2 clinical trials ongoing in HS and AD with data expected in the first half of 2025 KT-621 (STAT6) expected to start Phase 1 in the second half of 2024 and KT-294 (TYK2) expected to start Phase 1 in the first half of 2025, both with Phase 1 data in 2025 KT-253 (MDM2) and KT-333 (STAT3) Phase 1 dose escalation studies ongoing with clinical data updates at ASCO and EHA, respectively Well-capitalized with $745 million in cash as of March 31, 2024, and runway into the first half o ...

Financial Data and Key Metrics Changes - The company reported a cash balance of $745 million at the end of 2023, providing a runway into the first half of 2027, which supports its ambitious goals [22][44] - Research and development expenses for Q4 totaled $53 million, with an adjusted cash R&D spend of $47.7 million, reflecting a 13% increase from the same quarter last year [43][44] - The company earned $55 million in milestones from Sanofi, with $40 million recognized in Q4 and the remaining $15 million recorded as receivable [42][44] Business Line Data and Key Metrics Changes - The IRAK4 program has initiated two Phase 2 trials in hidradenitis suppurativa and atopic dermatitis, with top-line data expected in the first half of 2025 [35] - The KT-621 program, targeting STAT6, is set to enter clinical trials in the second half of 2024, with potential for a multibillion-dollar opportunity [36][37] - The oncology portfolio, including KT-333 and KT-253, is progressing through dose escalation, with additional proof of concept data expected this year [39][40] Market Data and Key Metrics Changes - The company aims to address the significant market opportunity for oral drugs in immunology, as 75% of patients taking biologics expressed a preference for oral alternatives [33][62] - The competitive landscape in immunology is noted to be growing, but the company believes it is well-positioned to offer differentiated oral therapies [116] Company Strategy and Development Direction - The company is focused on building a best-in-industry oral immunology pipeline with first-in-class programs targeting undrugged or poorly drugged targets [60][62] - The strategy includes leveraging the advantages of protein degraders to provide biologics-like specificity and activity while maintaining the convenience of oral administration [24][31] - The company is committed to exploring additional indications for its programs, including potential expansions beyond skin indications for IRAK4 [47][63] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the immunology programs and the potential to change treatment paradigms for immune-mediated diseases [9][34] - The company anticipates significant data releases in 2024 and 2025 that could impact its development strategy and market positioning [9][66] - Management emphasized the importance of data-driven decisions for advancing programs in both immunology and oncology [84][110] Other Important Information - The company plans to present preclinical data from the STAT6 and TYK2 programs at multiple scientific meetings this year [38] - The company has reached targeted degradation levels in clinical settings, with over 90% degradation achieved in the STAT3 program [95][121] Q&A Session Summary Question: What will inform the decision-making for the IRAK4 program's future indications? - Management indicated that the data from ongoing trials will guide decisions on potential expansions into respiratory, rheumatology, or GI indications [47] Question: How does the company view the competitive landscape for STAT6 and TYK2? - Management noted that while the landscape is competitive, there is significant white space for oral drugs with good safety profiles, positioning the company favorably [116] Question: What are the criteria for advancing the oncology programs? - The decision to advance will be based on data indicating opportunities to impact broad patient populations in both hematological and solid tumors [84][110]