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
first quarter ended March 31, 2023.
“Kymera made important progress in the first quarter against our
ambitious goal of building a fully integrated degrader medicines
company, and 2023 promises to be a year rich in data and milestones
that build upon our prior scientific achievements and further
establish the potential impact of our pipeline,” said Nello
Mainolfi, PhD, Founder, President and CEO. “We have recently
initiated the Phase 1 study of our MDM2 degrader KT-253, our fourth
clinical program, where we believe targeted protein degradation has
the potential to overcome the limitations of small molecule
inhibitors, and we plan to investigate the potential of KT-253 for
patients with liquid and solid tumors. With a growing pipeline,
including the first-in-class IRAK4 degrader KT-474 currently in
development with our partner Sanofi in hidradenitis suppurativa and
atopic dermatitis, a robust discovery engine focused heavily on
immunology, and a cash runway into the second half of 2025, we are
well positioned to continue to deliver first in class therapies for
patients around the world.”
Business Highlights and Recent Developments
- In January, at the J.P. Morgan Healthcare Conference, Kymera
shared its key research, development and corporate goals for 2023
and newly highlighted multiple programs, heavily focused on
immunology, that Kymera is advancing toward clinical
development.
- In February, Kymera presented an overview of its innovative
platform capabilities at the Society for Laboratory Automation and
Screening Annual International Conference & Exhibition,
including quantitative proteomics techniques and highly optimized
fragment libraries, which enable the Company’s proprietary drug
discovery engine to design and develop best-in-class precision
degrader medicines for undrugged and inadequately drugged
targets.
- In March, Kymera initiated a Phase 1 clinical trial evaluating
Kymera’s investigational MDM2 degrader KT-253.The Phase 1 study
will evaluate the safety, tolerability,
pharmacokinetics/pharmacodynamics and clinical activity of KT-253
in patients with relapsed or refractory high grade myeloid
malignancies, including acute myeloid leukemia (AML), acute
lymphocytic leukemia (ALL), lymphoma and solid tumors.
Anticipated Upcoming Milestones
- Kymera will deliver an oral presentation of the previously
disclosed clinical data from the KT-474 Phase 1 trial at the
European Academy of Dermatology and Venereology (EADV) Symposium in
Seville on May 18 at 11:45 AM CEST, sharing these data for the
first time at a scientific meeting.
- Kymera will present preclinical data highlighting KT-253’s
pharmacological profile at the European Hematology Association
(EHA) Congress in June and plans to share initial safety and
proof-of-mechanism data from the Phase 1 clinical trial later in
2023.
- The Company will provide clinical trial updates focused on
PK/PD and safety on its KT-333 and KT-413 programs at the
International Conference on Malignant Lymphoma (ICML) in June.
Kymera, as previously announced, intends to present data evaluating
anti-tumor activity in the target patient populations for KT-333
and KT-413 later this year.
- Kymera’s partner Sanofi plans to initiate Phase 2 clinical
studies of the IRAK4 degrader KT-474 (SAR444656) in hidradenitis
suppurativa (HS) and atopic dermatitis (AD), with the first study
in HS planned for initiation in 2023.
Program Background Information
IRAK4 Degrader Program (KT-474/SAR444656)
KT-474 is a potent, highly selective, orally bioavailable IRAK4
degrader, in development for the treatment of IL-1R/TLR-driven
complex inflammatory diseases where there is an opportunity to
significantly advance the standard of care in a broad variety of
diseases. In the Phase 1 trial, KT-474 showed evidence of robust
IRAK4 degradation in the blood and active skin lesions of HS and AD
patients and was generally well tolerated. Treatment with KT-474
was associated with a systemic anti-inflammatory response and
meaningful improvement in skin lesions and symptoms in both HS and
AD patients, with internal consistency between the effect on
inflammatory biomarkers and impact on clinical endpoints. KT-474
was generally safe and well-tolerated, with no serious adverse
events, no drug-related infections, and no dose interruptions or
discontinuations due to adverse events. Sanofi, which is
collaborating with Kymera on the development of KT-474 (SAR444656)
outside of the oncology and immune-oncology fields, will initiate
Phase 2 clinical trials of KT-474, with the first study in HS
planned for initiation in 2023.
STAT3 Degrader Program (KT-333)
KT-333 is designed as a potent degrader of STAT3, a
transcriptional regulator that has been linked to numerous cancers
as well as to inflammatory and autoimmune diseases. KT-333 is being
developed for the treatment of STAT3-dependent hematological
malignancies and solid tumors. The Phase 1 clinical trial of KT-333
is designed to evaluate the safety, tolerability, PK/PD and
clinical activity of KT-333 dosed weekly in adult patients with
relapsed and/or refractory lymphomas, leukemias and solid tumors.
In December 2022, Kymera shared that Dose Level (DL) 1 had been
completed with a total of 4 patients enrolled. All patients were
heavily pretreated with multiple prior regimens and included 3 with
solid tumors and 1 with cutaneous T-cell lymphoma. Plasma PK and PD
translated as expected in humans, with mean maximum STAT3
degradation in PBMC following the first 2 doses averaging 66% and
with maximum STAT3 knockdown of up to 86% as measured by mass
spectrometry. There were no dose-limiting toxicities or
treatment-related serious adverse events reported at this dose.
KT-333 has been granted orphan drug designation by the U.S. Food
and Drug Administration for both the treatment of cutaneous T-cell
lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL).
The Phase 1a dose escalation stage is ongoing, recruiting
broadly across solid and liquid tumors. Kymera will present a
clinical update focused on PK/PD and safety at the ICML meeting in
June and, as previously announced, intends to present data
evaluating anti-tumor activity in the target patient population
later this year.
More information on the Phase 1 study can be found at
www.clinicaltrials.gov, identifier NCT05225584.
IRAKIMiD Degrader Program (KT-413)
KT-413 is a novel heterobifunctional degrader targeting both
IRAK4 and the IMiD substrates Ikaros and Aiolos. Designed to
address both the IL-1R/TLR and Type 1 IFN pathways synergistically
with a single molecule, KT-413 is in development for the treatment
of MYD88-mutant B cell malignancies. The Phase 1 clinical trial of
KT-413 is designed to evaluate the safety, tolerability, PK/PD and
clinical activity of KT-413 administered as an IV infusion once
every 3 weeks to adult patients with relapsed and/or refractory
B-cell non-Hodgkin's lymphomas. In December 2022, Kymera announced
that the first two dose levels had been completed. Patients were
heavily pretreated with multiple prior regimens and included
follicular lymphoma and DLBCL, which were both wild-type for MYD88.
Plasma PK and PD translated as expected in humans with both dose
levels showing dose-dependent degradation of IRAK4, Ikaros and
Aiolos in PBMC, with up to 95/100% knockdown of Ikaros/Aiolos and
40% knockdown of IRAK4 at the second dose level. Serial tumor
biopsies at Cycle 3/Day 4 in the patient treated at DL1 showed
comparable knockdown of Ikaros/Aiolos and IRAK4 as in plasma. There
were no dose-limiting toxicities or treatment-related serious
adverse events and no neutropenia observed in the two patient
cohorts.
The Phase 1a dose escalation portion of the trial is ongoing,
recruiting a broad population of B cell lymphoma patients. Kymera
will provide a clinical update focused on PK/PD and safety at the
ICML meeting in June and, as previously announced, intends to
present data evaluating anti-tumor activity in the target patient
population later this year.
More information on the Phase 1 study can be found at
www.clinicaltrials.gov, identifier NCT05233033.
MDM2 Degrader Program (KT-253)
KT-253 targets MDM2, the crucial regulator of the most common
tumor suppressor, p53. p53 remains intact (wild type) in close to
50% of cancers, meaning that it retains its ability to modulate
cancer cell growth. While small molecule inhibitors have been
developed to stabilize and upregulate p53 expression, they induce a
feedback loop that increases MDM2 protein levels, which can repress
p53 and limit their efficacy. In preclinical studies, KT-253 has
demonstrated the ability to overcome the MDM2 feedback loop and
rapidly induce cancer cell death, even with brief exposures. This
may also enable an improved therapeutic index, resulting in a
superior efficacy/safety profile.
The Phase 1 study initiated in March will evaluate the safety,
tolerability, pharmacokinetics/pharmacodynamics, and clinical
activity of KT-253 in patients with relapsed or refractory high
grade myeloid malignancies, including acute myeloid leukemia (AML),
acute lymphocytic leukemia (ALL), lymphoma and solid tumors.
Patients in the KT-253 Phase 1a dose escalation study will receive
IV doses of KT-253 administered once every 3 weeks. The open-label
study is intended to identify the recommended Phase 2 dose for
KT-253, and is comprised of two arms, with ascending doses of
KT-253 in each arm. The first arm will consist of patients with
lymphomas and advanced solid tumors and the second arm will consist
of patients with high grade myeloid malignancies and ALL.
More information on the Phase 1 study can be found at
www.clinicaltrials.gov, identifier NCT05775406.
Platform and Discovery Programs
Kymera is leveraging the Company’s proprietary E3 Ligase
Whole-Body Atlas, including the differential expression profile of
known E3 ligases, to pursue targets and indications that may
benefit from tissue-restricted or -selective degradation. Kymera
has also expanded the Company’s platform to develop a new
generation of molecular glue degraders for high value undrugged and
non-ligandable targets, exploiting a newly identified degron motif.
Multiple programs are approaching development stage in 2023.
Conference Call
To access the conference call via phone, please dial +1 (833)
630-2127 (U.S.) 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.
First Quarter 2023 Financial Results
Collaboration Revenues: Collaboration revenues
were $9.5 million for the first quarter of 2023 compared to $9.6
million the first quarter of 2022. Collaboration revenues include
revenue from the Company’s Sanofi and Vertex collaborations.
Research and Development Expenses: Research and
development expenses were $42.2 million for the first quarter of
2023 compared to $35.9 million for the first 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 $4.7 million for the first
quarter of 2023 compared to $3.9 million for the first quarter of
2022.
General and Administrative Expenses: General
and administrative expenses were $12.6 million for the first
quarter of 2023 compared to $10.6 million for the first quarter of
2022. The increase was primarily due to 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 G&A were $4.7
million for the first quarter of 2023 compared to $4.0 million for
the first quarter of 2022.
Net Loss: Net loss was $40.9 million for the
first quarter of 2023 compared to a net loss of $36.7 million for
the first quarter of 2022.
Cash and Cash Equivalents: As of March 31,
2023, Kymera had approximately $516 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 that 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-413, KT-333 and KT-253, 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 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
year ended December 31, 2022 filed on February 23, 2023, 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
515,894 |
|
$ |
559,494 |
|
Property and
equipment, net |
|
|
17,432 |
|
|
13,334 |
|
Right-of-use
assets, operating lease |
|
|
56,604 |
|
|
8,909 |
|
Other assets |
|
|
23,975 |
|
|
21,397 |
|
Total assets |
|
$ |
613,905 |
|
$ |
603,134 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Deferred
revenue |
|
$ |
57,114 |
|
$ |
63,260 |
|
Operating lease
liabilities |
|
|
66,429 |
|
|
14,681 |
|
Other
liabilities |
|
|
28,357 |
|
|
35,042 |
|
Total
liabilities |
|
|
151,900 |
|
|
112,983 |
|
Total
stockholders’ equity |
|
|
462,005 |
|
|
490,151 |
|
Total liabilities
and stockholders’ equity |
|
$ |
613,905 |
|
$ |
603,134 |
|
KYMERA THERAPEUTICS, INC. |
Consolidated Statements of Operations |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
Collaboration Revenue—from related parties |
$ |
9,466 |
|
|
$ |
9,622 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research
and development |
$ |
42,227 |
|
|
$ |
35,944 |
|
General
and administrative |
|
12,565 |
|
|
|
10,611 |
|
Total
operating expenses |
|
54,792 |
|
|
|
46,555 |
|
Loss
from operations |
|
(45,326 |
) |
|
|
(36,933 |
) |
Other
income (expense): |
|
|
|
Interest and other income |
|
4,453 |
|
|
|
290 |
|
Interest and other expense |
|
(55 |
) |
|
|
(41 |
) |
Total other income |
|
4,398 |
|
|
|
249 |
|
Net loss
attributable to common stockholders |
$ |
(40,928 |
) |
|
$ |
(36,684 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.70 |
) |
|
$ |
(0.71 |
) |
Weighted average common stocks
outstanding, basic and diluted |
|
58,187,038 |
|
|
|
51,651,125 |
|
Investor
Contact: Bruce Jacobs Chief Financial
Officer investors@kymeratx.com 857-285-5300 Chris
Brinzey Managing Director,
Westwicke chris.brinzey@westwicke.com 339-970-2843 |
Media
Contact: Todd Cooper Senior Vice President,
Corporate
Affairs media@kymeratx.com 857-285-5300 |
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