Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing targeted protein degradation
(TPD) to deliver novel small molecule protein degrader medicines,
today reported business highlights and financial results for the
second quarter ended June 30, 2023.
“Kymera has made strong progress with our three proprietary
clinical programs over the last quarter, including dosing our first
patient in the KT-253 Phase 1 study and sharing data that both
KT-333 and KT-413 reached degradation levels that were associated
with anti-tumor activity in preclinical models. We believe these
findings reinforce Kymera’s ability to translate our preclinical
pharmacokinetic, pharmacodynamic and safety models to patients and
provide a strong foundation as we expand our pipeline with
potentially best-in-class, high-value programs. We expect to share
updates on these programs later this year,” said Nello Mainolfi,
Founder, President and CEO, Kymera Therapeutics. “Additionally, our
partner Sanofi expects to initiate the first two Phase 2 clinical
trials for KT-474 in the fourth quarter, moving us forward on our
mission of building a fully-integrated global medicines
company.”
Business Highlights and Recent Developments
- The Company presented clinical data
from the KT-474 Phase 1 trial at the European Academy of
Dermatology and Venereology (EADV) Symposium, sharing these data
for the first time at a scientific meeting.
- The Company announced the first
patient was dosed in the Phase 1 clinical trial evaluating its
investigational MDM2 degrader, KT-253.
- The U.S. Food and Drug
Administration (FDA) granted orphan drug designation to KT-253 for
the treatment of Acute Myeloid Leukemia (AML).
- At the European Hematology Association (EHA) Congress, the
Company presented data demonstrating superior efficacy of MDM2
degrader KT-253 compared to small molecule inhibitors in
preclinical leukemia models.
- In conjunction with the
International Conference on Malignant Lymphoma (ICML), Kymera
provided clinical trial updates for its KT-333 and KT-413 oncology
programs focused on pharmacokinetic/pharmacodynamic (PK/PD) and
safety from additional patient cohorts showing target knockdown at
or near levels that were associated with efficacy in preclinical
tumor models. The KT-333 clinical data was presented in a poster at
ICML.
- At the American Society for Mass
Spectrometry (ASMS) Annual Meeting, Kymera presented two posters
focused on Kymera’s powerful drug discovery engine and the advanced
proteomics technologies utilized to provide deep insights into
degrader selectivity and mechanism-of-action in physiologically
relevant cellular settings at high resolution and
dimensionality.
- In collaboration with the Raymond
Birge laboratory at the Department of Microbiology, Biochemistry
and Molecular Genetics, and Center for Cell Signaling at Rutgers
University, Kymera published a paper in Frontiers in Immunology
(link) demonstrating degraders can be designed to selectively
degrade multiple tumor-associated macrophage (TAM) receptors and
modulate receptor expression in vitro and in vivo. While not
currently in the active pipeline, this work demonstrates the
utility of proteome editing enabled by degraders toward
therapeutically relevant pathway biology in preclinical models and
shows the technology could serve as a viable therapeutic strategy
for targeting MERTK and other TAM receptors that are expressed
across a range of liquid and solid tumors.
- The Company announced the
appointment of Jeremy Chadwick, Ph.D., as Chief Operating Officer.
Dr. Chadwick joined Kymera with extensive experience overseeing
global development operations, regulatory and program management at
a range of biopharmaceutical companies. As a member of the
Company’s senior management team, Dr. Chadwick will develop and
execute near-term and long-range strategies to maximize the impact
of Kymera’s expanding pipeline.
- In July, Justine Koenigsberg joined
Kymera as Vice President and Head of Investor Relations. Ms.
Koenigsberg has more than 25 years of investor relations and
corporate communications experience within the biotechnology
industry. She most recently served as Senior Vice President,
Corporate Communications and Investor Relations at Concert
Pharmaceuticals, Inc. Prior to joining Concert, she held senior
communication roles at ViaCell, Inc. and Transkaryotic Therapies,
Inc. (TKT) where she developed and implemented a variety of
communication strategies and managed their investor relations
programs. Before TKT, she held communications positions at Vertex
Pharmaceuticals, Inc. Ms. Koenigsberg is a member of the National
Investors Relations Institute and served on the Board of Directors
and as a Past-President of its Boston Chapter. She holds a B.S. in
Business Administration from Northeastern University.
Anticipated Upcoming Milestones
- Kymera’s partner Sanofi plans to initiate Phase 2 clinical
trials of IRAK4 degrader KT-474 (SAR444656) in both HS and AD in
the fourth quarter of 2023.
- Kymera plans to share updates on its clinical-stage oncology
programs later this year, including data evaluating anti-tumor
activity in the target patient populations for KT-333 and KT-413
and initial safety and proof-of-mechanism data from the KT-253
Phase 1 clinical trial.
Program Background Information
For more information on Kymera’s pipeline visit our website:
https://www.kymeratx.com/pipeline/.
Conference Call
To access the conference call via phone, please dial +1 (800)
715-9871 (US) or +1 (646) 307-1963 (International) and ask to join
the Kymera Therapeutics call or provide Conference ID 7353312. 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.
Second Quarter 2023 Financial Results
Collaboration Revenues: Collaboration revenues
were $16.5 million for the second quarter of 2023 compared to $11.5
million for the second quarter of 2022. Collaboration revenues
include revenue from the Company’s Sanofi and Vertex
collaborations.
Research and Development Expenses: Research and
development expenses were $45.8 million for the second quarter of
2023 compared to $41.3 million for the second quarter of 2022. This
increase was primarily due to increased expenses related to the
investment in our STAT3, IRAKIMiD, and MDM2 clinical stage
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 R&D were $5.7 million for the second
quarter of 2023 compared to $4.8 million for the second quarter of
2022.
General and Administrative Expenses: General
and administrative expenses were $14.1 million for the second
quarter of 2023 compared to $11.0 million for the second 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 $5.5 million for the second quarter of
2023 compared to $4.9 million for the second quarter of 2022.
Net Loss: Net loss was $38.8 million for the
second quarter of 2023 compared to a net loss of $40.3 million for
the second quarter of 2022.
Cash and Cash Equivalents: As of June 30, 2023,
Kymera had approximately $472 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
second half of 2025. Its existing cash is expected to take the
company past the proof-of-concept Phase 2 data for KT-474, as well
as early proof-of-concept data for KT-253, KT-333 and KT-413, while
Kymera continues to identify opportunities to accelerate growth and
expand its pipeline, technologies and clinical indications.
About Kymera TherapeuticsKymera 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 of novel
therapeutic candidates designed to address the most promising
targets and provide patients with more effective treatments.
Kymera’s initial programs target IRAK4, IRAKIMiD, 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 by both the Boston Globe and the Boston
Business Journal as one of Boston’s top workplaces. For more
information about our people, science and pipeline, please visit
www.kymeratx.com or follow us on Twitter or LinkedIn.
About Kymera’s Pegasus™ PlatformKymera’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 medical needs.
Cautionary Note Regarding Forward-Looking
StatementsThis 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 the IRAK4,
IRAKIMiD, STAT3, and MDM2 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 second half
of 2025. 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 impact of COVID-19 or other pandemics or epidemics on
countries or regions in which we have operations or do business, as
well as on 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; 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, including those for KT-474, KT-333, KT-413 and
KT-253; 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; 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)(Unaudited) |
|
|
June 30, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
472,333 |
|
$ |
559,494 |
Property and
equipment, net |
|
|
27,494 |
|
|
13,334 |
Right-of-use
assets, operating lease |
|
|
55,687 |
|
|
8,909 |
Other assets |
|
|
26,431 |
|
|
21,397 |
Total assets |
|
$ |
581,945 |
|
$ |
603,134 |
Liabilities and Stockholders’ Equity |
|
|
|
|
Deferred
revenue |
|
$ |
44,723 |
|
$ |
63,260 |
Operating lease
liabilities |
|
|
73,068 |
|
|
14,681 |
Other
liabilities |
|
|
28,726 |
|
|
35,042 |
Total
liabilities |
|
|
146,517 |
|
|
112,983 |
Total
stockholders’ equity |
|
|
435,428 |
|
|
490,151 |
Total liabilities
and stockholders’ equity |
|
$ |
581,945 |
|
$ |
603,134 |
|
|
|
|
|
|
|
KYMERA THERAPEUTICS, INC. |
Consolidated Statements of Operations and Comprehensive
Loss |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended June
30, |
|
Six Months Ended June
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration Revenue—from
related parties |
$ |
16,513 |
|
|
$ |
11,514 |
|
|
$ |
25,979 |
|
|
$ |
21,136 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
45,767 |
|
|
$ |
41,293 |
|
|
$ |
87,994 |
|
|
$ |
77,238 |
|
General and administrative |
|
14,129 |
|
|
|
11,031 |
|
|
|
26,694 |
|
|
|
21,642 |
|
Total operating expenses |
|
59,896 |
|
|
|
52,324 |
|
|
|
114,688 |
|
|
|
98,880 |
|
Loss from operations |
|
(43,383 |
) |
|
|
(40,810 |
) |
|
|
(88,709 |
) |
|
|
(77,744 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest and other income |
|
4,632 |
|
|
|
594 |
|
|
|
9,085 |
|
|
|
884 |
|
Interest and other expense |
|
(48 |
) |
|
|
(41 |
) |
|
|
(103 |
) |
|
|
(81 |
) |
Total other income |
|
4,584 |
|
|
|
553 |
|
|
|
8,982 |
|
|
|
803 |
|
Net loss attributable to common
stockholders |
$ |
(38,799 |
) |
|
$ |
(40,257 |
) |
|
$ |
(79,727 |
) |
|
$ |
(76,941 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.67 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.37 |
) |
|
$ |
(1.49 |
) |
Weighted average common stocks
outstanding, basic and diluted |
|
58,326,963 |
|
|
|
51,772,440 |
|
|
|
58,257,387 |
|
|
|
51,712,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contacts: Bruce Jacobs Chief
Financial
Officer investors@kymeratx.com 857-285-5300 Justine
KoenigsbergVice President, Investor
Relationsinvestors@kymeratx.com857-285-5300 |
Media Contact:Todd Cooper Senior Vice
President, Corporate
Affairs media@kymeratx.com 857-285-5300 |
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