Full Press Release Details
Kymera Therapeutics Announces Third Quarter 2023 Financial Results and
Provides a Business Update
First patient dosed in KT-474/SAR444656 (IRAK4) Phase 2 HS clinical trial, generating a
$40 million milestone payment from partner Sanofi; dosing of first patient in Phase 2 AD trial expected in the fourth quarter of 2023
ASH abstract to be released today highlights KT-333 (STAT3) safety, PK/PD and initial anti-tumor
activity in Phase 1 clinical trial
KT-253 (MDM2) degrader achieved clinical proof-of-mechanism in Phase 1 clinical trial and demonstrated anti-tumor activity in first solid tumor cohort without dose-limiting toxicities or hematologic adverse events
KT-413 (IRAKIMiD) development to be discontinued for strategic reasons despite reaching
expected degradation levels and lack of dose-limiting toxicities
Kymera to focus resources on its growing immunology pipeline
targeting large opportunities with oral degrader mechanisms, to be disclosed at a virtual Immunology R&D Day on January 4, 2024
Cash balance of $435 million, representing an extended runway to the first half of 2026
Company to hold call and webcast today at 8:00 a.m. ET
Watertown, Mass. (November 2, 2023) Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new
class of small molecule medicines using targeted protein degradation (TPD), today reported financial results for the third quarter ended September 30, 2023, and provided business updates on its pipeline of protein degraders.
This was an important quarter for Kymera, with our clinical programs demonstrating encouraging progress and reinforcing the promise of protein
degradation to change the way we treat disease, said Nello Mainolfi, Ph.D., Founder, President and CEO, Kymera Therapeutics. Our partner Sanofi has begun Phase 2 studies of KT-474, and our oncology
programs KT-333 and KT-253 have both shown signs of anti-tumor activity in liquid and solid tumor types, providing a critical foundation for how we intend to build even
more value for patients, physicians and shareholders.
In addition, with increased focus on the transformative opportunity we have in
immunology, our discovery engine has produced several promising programs that we believe can have a significant impact on the way these complex diseases are managed. We intend to share more details on our strategy and these emerging programs,
including the path to clinical data, in early January at our Immunology R&D Day, added Dr. Mainolfi. With the promise of our growing pipeline, and in the context of the changing diffuse large
B-cell lymphoma treatment landscape, we have decided to discontinue the development of KT-413, despite the program having achieved desired target degradation levels
without dose-limiting toxicities. This decision, which reflects financial discipline around program prioritization, will allow us to focus resources on programs that have the potential to address large patient populations with significant need and
clear commercial opportunity. Importantly, we have extended our runway into the first half of 2026, which now reaches well beyond key readouts for our clinical programs.
Business Highlights, Recent Developments and Upcoming Milestones
KT-474/SAR444656 IRAK4 Degrader
KT-333 STAT3 Degrader
KT-253 MDM2 Degrader
KT-413 IRAKiMID Degrader
Program Background Information
information on Kymera s pipeline visit our website: https://www.kymeratx.com/pipeline/.
Kymera will host a conference call and webcast today, November 2, 2023, at 8:00 a.m. ET. To access the conference call via phone, please dial +1 (833) 630-2127 or +1 (412) 317-1846 (International) and ask to join the Kymera Therapeutics call. A live webcast of the event will be available under Events and Presentations
in the Investors section of the Company s website at www.kymeratx.com. A replay of the webcast will be archived and available following the event.
Third Quarter 2023 Financial Results
Collaboration Revenues: Collaboration revenues were $4.7 million for the third quarter of 2023 compared to $9.6 million for the third quarter
of 2022. Collaboration revenues in the third quarter of 2023 include revenue from the Company s Sanofi collaboration, but does not include Phase 2 milestone payments which Kymera expects to begin to recognize as revenue in the fourth quarter of
Research and Development Expenses: Research and development expenses were $48.1 million for the third quarter of 2023 compared to
$43.9 million for the third quarter of 2022. This increase was primarily due to increased expenses related to the investment in the Company s oncology clinical programs, platform and discovery programs, as well as an increase in occupancy
and related costs due to continued growth in the research and development organization. Stock based compensation expenses included in research and development were $5.8 million for the third quarter of 2023 compared to $4.9 million for the
third quarter of 2022.
General and Administrative Expenses: General and administrative expenses were $14.1 million for the third quarter of
2023 compared to $10.6 million for the third quarter of 2022. 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, occupancy, and
other expenses from an increase in headcount to support growth as a public company. Stock based compensation expenses included in general and administrative expenses were $5.9 million for the third quarter of 2023 compared to $4.2 million
for the third quarter of 2022.
Net Loss: Net loss was $52.9 million for the third quarter of 2023 compared to a net loss of
$43.0 million for the third quarter of 2022.
Cash and Cash Equivalents: As of September 30, 2023, Kymera had $435 million in cash,
cash equivalents, and investments. Kymera expects that its cash and cash equivalents will provide the company with an anticipated cash runway into the first half of 2026. Its existing cash is expected to take the Company beyond the Phase 2 data for KT-474, as well as additional proof-of-concept data for KT-253 and KT-333, while Kymera continues to identify opportunities to accelerate growth and expand its pipeline, technologies and clinical indications.
About Kymera Therapeutics
Kymera is a biopharmaceutical
company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera s Pegasus platform is a powerful drug discovery engine,
advancing novel small molecule programs designed to harness the body s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline
novel therapeutic candidates designed to address the most promising targets and provide patients with more effective treatments. Kymera s initial programs target IRAK4 and STAT3 within the IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.
Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a Fierce 15 company by Fierce Biotech and has been recognized
About Kymera s Pegasus Platform
Kymera s Pegasus platform is a powerful drug discovery engine that enables the discovery of novel small molecule protein degrader medicines designed to
target and disrupt specific protein complexes and full signaling cascades in disease, placing once elusive disease targets within reach. The key components of the platform combine Kymera s broad understanding of the localization and expression
levels of the hundreds of E3 ligases in the human body with the Company s proprietary E3 Ligase Binders Toolbox, and advanced chemistry, biology, and computational capabilities to develop protein degraders that address significant, unmet
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 by Kymera Therapeutics regarding its: strategy, business plans and objectives for our clinical stage degrader programs; plans and timelines for the preclinical and clinical development of its
product candidates, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials; the ability to initiate new clinical
programs; and Kymera s financial condition and expected cash runway into the first half of 2026. The words may, might, will, could, would, should, expect,
plan, anticipate, intend, believe, expect, estimate, seek, predict, future, project, potential, continue,
target 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 those expressed or implied by any forward-looking
statements contained in this press release, including, without limitation, risks associated with: the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the
delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics drug candidates, including those for KT-474,
KT-333, KT-413 and KT-253; the risk that the results of current preclinical studies and clinical trials may not be predictive of
future results in connection with current or future preclinical and clinical trials; Kymera Therapeutics ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera
Therapeutics planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; the risks associated with pandemics or epidemics; and Kymera Therapeutics relationships with its existing and
future collaboration partners. These and other risks and uncertainties are described in greater detail in the section entitled Risk Factors in the Annual Report on Form 10-K for the period ended
December 31, 2022, and most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics subsequent filings with
the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics
explicitly disclaims 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.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| September 30, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and marketable securities | $ | 434,813 | $ | 559,494 | ||||
| Property and equipment, net | 36,145 | 13,334 | ||||||
| Right-of-use assets, operating lease | 54,955 | 8,909 | ||||||
| Other assets | 26,465 | 21,397 | ||||||
| Total assets | $ | 552,378 | $ | 603,134 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Deferred revenue | $ | 43,773 | $ | 63,260 | ||||
| Operating lease liabilities | 79,190 | 14,681 | ||||||
| Other liabilities | 33,880 | 35,042 | ||||||
| Total liabilities | 156,843 | 112,983 | ||||||
| Total stockholders equity | 395,535 | 490,151 | ||||||
| Total liabilities and stockholders equity | $ | 552,378 | $ | 603,134 |
KYMERA THERAPEUTICS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Collaboration Revenue from related parties | $ | 4,728 | $ | 9,551 | $ | 30,707 | $ | 30,687 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 48,117 | $ | 43,877 | $ | 136,111 | $ | 121,115 | ||||||||
| General and administrative | 14,120 | 10,556 | 40,814 | 32,198 | ||||||||||||
| Total operating expenses | 62,237 | 54,433 | 176,925 | 153,313 | ||||||||||||
| Loss from operations | (57,509 | ) | (44,882 | ) | (146,218 | ) | (122,626 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 4,683 | 1,916 | 13,768 | 2,800 | ||||||||||||
| Interest and other expense | (41 | ) | (36 | ) | (144 | ) | (117 | ) | ||||||||
| Total other income | 4,642 | 1,880 | 13,624 | 2,683 | ||||||||||||
| Net loss attributable to common stockholders | $ | (52,867 | ) | $ | (43,002 | ) | $ | (132,594 | ) | $ | (119,943 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.90 | ) | $ | (0.79 | ) | $ | (2.27 | ) | $ | (2.28 | ) | ||||
| Weighted average common stocks outstanding, basic and diluted | 58,421,859 | 54,535,514 | 58,312,813 | 52,600,103 |