Kymera Therapeutics, Inc 8-K, filed Nov 4, 2025
Kymera Therapeutics, Inc. (KYMR)
About this 8-K
Kymera Therapeutics, Inc filed this 8-K on November 4, 2025.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
Kymera Therapeutics, Inc.
(Address of principal executive offices, including zip code)
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(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trade Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition
On November 4, 2025, Kymera Therapeutics, Inc. announced its financial results for the quarter ended September 30, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Exhibits
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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Press release issued by Kymera Therapeutics, Inc. on November 4, 2025, furnished herewith. |
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104 |
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Cover Page Interactive Data |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Kymera Therapeutics, Inc. |
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Date: November 4, 2025 |
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By: |
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/s/ Nello Mainolfi |
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Nello Mainolfi, Ph.D. |
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President and Chief Executive Officer |
Exhibit 99.1
Kymera Therapeutics Announces Third Quarter 2025 Financial Results and Provides a Business Update
Enrollment and dosing completed in KT-621 (STAT6) BroADen Phase 1b trial in atopic dermatitis (AD) patients, with data to be reported in December 2025
Initiated KT-621 BROADEN2 Phase 2b trial in AD
KT-621 BREADTH Phase 2b trial in asthma on track to initiate in 1Q26
KT-579 (IRF5) IND-enabling studies completed, with Phase 1 clinical trial expected to start in early 2026
Well-capitalized with $979 million in cash as of September 30, 2025, and runway into the second half of 2028
Company to hold video conference call and webcast today at 8:30 a.m. ET
Watertown, Mass. (November 4, 2025) – Kymera Therapeutics, Inc.(NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today reported financial results for the third quarter ended September 30, 2025, and provided business highlights and updates on its pipeline.
“Our team has made impressive research, clinical, and regulatory progress this quarter to advance our first-in-class oral degrader medicines, and we look forward to several important milestones through the fourth quarter and early next year,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “We’ve completed patient enrollment and dosing in the KT-621 BroADen Phase 1b trial in AD, marking a significant moment in the industry as the first STAT6-directed agent in patients, and we plan to share the full data set next month. Additionally, we’ve initiated the KT-621 BROADEN2 Phase 2b trial in AD and are on track to start BREADTH, the Phase 2b asthma study, in the first quarter of 2026, positioning us on an accelerated development path to multiple registrational studies across areas of significant unmet need.”
Dr. Mainolfi continued, “We were pleased to share additional preclinical efficacy data for KT-579 showcasing our novel oral approach to modulating IRF5, a key driver of multiple autoimmune disease pathologies. This program is on track for clinical entry in early 2026. These important milestones across our industry leading oral immunology pipeline underscore our focus on delivering groundbreaking medicines to patients around the world.”
Business Highlights, Recent Developments and Upcoming Milestones
STAT6 Degrader Program
KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation. In the Phase 1 clinical study in healthy volunteers, KT-621 demonstrated complete STAT6 degradation in blood and skin following low daily oral doses, reductions of multiple disease relevant Type 2 biomarkers, and a safety profile undifferentiated from placebo. KT-621, the first STAT6-directed drug to enter clinical evaluation, has the potential to transform treatment paradigms for more than 130 million patients around the
world, including children and adults, suffering from Type 2 diseases such as atopic dermatitis (AD), asthma, bullous pemphigoid (BP), chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others.
IRF5 Degrader Program
KT-579 is an investigational, first-in-class, oral degrader of IRF5, a genetically validated transcription factor and master regulator of immunity. KT-579 has the potential to selectively block inflammation and restore immune regulation by inhibiting pro-inflammatory cytokines, Type I IFN, and autoantibody production while sparing normal cell function. In preclinical studies, KT-579 degraded IRF5 across multiple preclinical species and in all disease-relevant tissues. In preclinical models of lupus and rheumatoid arthritis (RA), KT-579 was equal or more efficacious than small molecule inhibitors and biologics currently marketed or in the clinic. In preclinical safety studies, KT-579 did not show any adverse effects of any type at all doses and concentrations tested. KT-579 has the potential to be the first novel mechanism with broad utility in diseases where effective and well tolerated oral therapies are needed, such as lupus, Sjögren's, inflammatory bowel disease (IBD), RA and others.
Partnered Programs
Corporate Updates
Financial Results
Collaboration Revenues: Collaboration revenues were $2.8 million for the third quarter of 2025 compared to $3.7 million for the third quarter of 2024. Collaboration revenues recognized in the third quarter of 2025 were all attributable to the Company’s collaboration with Gilead Sciences. Collaboration
revenues recognized in the third quarter of 2024 were all attributable to the Company’s collaboration with Sanofi.
Research and Development Expenses: Research and development expenses were $74.1 million for the third quarter of 2025 compared to $60.4 million for the third quarter of 2024. This increase was primarily due to increased expenses related to the investment in the Company’s STAT6 program, platform and discovery programs, as well as costs related to continued growth in the research and development organization. Stock based compensation expenses included in R&D were $8.4 million and $7.6 million for the third quarters of 2025 and 2024, respectively.
General and Administrative Expenses: General and administrative expenses were $17.3 million for the third quarter of 2025 compared to $15.5 million for the third quarter of 2024. The increase was primarily due to an increase in legal and professional service fees in support of the Company’s growth and an increase in personnel, facility, and other expenses. Stock based compensation expenses included in G&A were $7.4 million and $7.3 million for the third quarters of 2025 and 2024, respectively.
Net Loss: Net loss was $82.2 million for the third quarter of 2025 compared to $62.5 million for the third quarter of 2024.
Cash and Cash Equivalents: As of September 30, 2025, Kymera had $978.7 million in cash, cash equivalents and investments. Kymera expects that its cash balance will provide the Company with a cash runway into the second half of 2028, beyond multiple clinical inflection points in our pipeline.
Event Details
Kymera will host a video conference call today, November 4, 2025, at 8:30 a.m. ET. To join the call please use this link to register. A live webcast of the event will be available under News and Events in the Investors section of the Company’s website at https://www.kymeratx.com/. A replay of the webcast will be archived and available following the event for three months.
About Kymera Therapeutics
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on
the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, including for the Phase 1b data readout of KT-621 in AD patients in December 2025, the initiation of Phase 2b studies of KT-621 in patients with AD and asthma in the fourth quarter of 2025 and first quarter of 2026, respectively, the effect of initial parallel development of Phase 2b studies in AD and asthma patients on acceleration of late parallel development across multiple indications, and the preliminary cross-study assessments comparing non-head-to-head clinical data of KT-621 to published data for dupilumab, the advancement of KT-579 into Phase 1 clinical testing in early 2026, the KT-485/SAR447971 program, objectives on the development of CDK2 degraders, and Kymera’s financial condition and expected cash runway into the second half of 2028. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target," “upcoming” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: the risk that cross-trial comparisons may not be reliable as no head-to-head trials have been conducted comparing KT-621 to dupilumab, and Phase 1 clinical data for KT-621 may not be directly comparable to dupilumab’s clinical data due to differences in molecule composition, trial protocols, dosing regimens, and patient populations and characteristics, that the results from the Phase 1b KT-621 trial may differ from the Phase 1a KT-621 data, that preclinical and clinical data, including the results from the Phase 1a trial of KT-621, is not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidate, uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with and submissions to regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements, the ability of each party to perform its obligations under the Kymera and Gilead exclusive option and license agreement, the unexpected emergence of adverse events or other undesirable side effects during preclinical and clinical development, whether Kymera will be able to fund development activities and achieve development goals, including those under the Kymera and Gilead collaboration, and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
KYMERA THERAPEUTICS, INC. |
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Consolidated Balance Sheets |
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(In thousands, except share and per share amounts) |
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(Unaudited) |
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September 30, |
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December 31, |
Assets |
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Cash, cash equivalents and marketable securities |
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$ 978,737 |
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$ 850,903 |
Property and equipment, net |
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45,128 |
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50,457 |
Right-of-use assets, operating lease |
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42,947 |
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47,407 |
Other assets |
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35,232 |
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29,268 |
Total assets |
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$ 1,102,044 |
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$ 978,035 |
Liabilities and Stockholders’ Equity |
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Deferred revenue |
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$ 37,236 |
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$ 13,576 |
Operating lease liabilities |
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80,303 |
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84,017 |
Other liabilities |
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38,247 |
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44,823 |
Total liabilities |
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155,786 |
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142,416 |
Total stockholders’ equity |
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946,258 |
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835,619 |
Total liabilities, preferred stock and stockholders’ equity |
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$ 1,102,044 |
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$ 978,035 |
KYMERA THERAPEUTICS, INC. |
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Consolidated Statements of Operations and Comprehensive Loss |
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(Unaudited) |
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Three Months Ended |
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Nine Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
Collaboration Revenue |
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$ 2,764 |
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$ 3,741 |
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$ 36,341 |
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$ 39,678 |
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Operating expenses: |
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Research and development |
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$ 74,094 |
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$ 60,410 |
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$ 232,737 |
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$ 168,431 |
General and administrative |
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17,336 |
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15,455 |
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51,252 |
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47,202 |
Impairment of long-lived assets |
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3,855 |
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— |
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3,855 |
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4,925 |
Total operating expenses |
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95,285 |
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75,865 |
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287,844 |
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220,558 |
Loss from operations |
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(92,521) |
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(72,124) |
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(251,503) |
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(180,880) |
Other income (expense): |
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Interest and other income |
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10,444 |
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9,697 |
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27,413 |
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27,964 |
Interest and other expense |
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(98) |
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(60) |
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(280) |
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(190) |
Total other income |
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10,346 |
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9,637 |
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27,133 |
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27,774 |
Net loss attributable to common stockholders |
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$ (82,175) |
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$ (62,487) |
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$ (224,370) |
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$ (153,106) |
Net loss per share attributable to common stockholders, basic and diluted |
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$ (0.94) |
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$ (0.82) |
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$ (2.71) |
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$ (2.09) |
Weighted average common stocks outstanding, basic and diluted |
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87,300,286 |
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76,125,975 |
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82,653,142 |
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73,330,338 |
Investor and Media Contact:
Justine Koenigsberg
Vice President, Investor Relations
investors@kymeratx.com
media@kymeratx.com
857-285-5300