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
- Sanofi initiated two randomized, placebo-controlled Phase 2
trials evaluating KT-474 for the treatment of hidradenitis
suppurativa (HS) and atopic dermatitis (AD), and the first patient
was dosed in the HS trial in October 2023. Under the terms of the
Sanofi/Kymera collaboration, the dosing of the first patient in the
HS trial generated a milestone payment of $40 million.
KT-333 STAT3 Degrader
- An abstract to be released by the American Society of
Hematology (ASH) today, November 2, 2023, reports data from the
KT-333 Phase 1 clinical trial through a July 10, 2023 cut-off. Of
the 21 patients enrolled through dose level (DL) 5, 12 were
evaluable for disease assessment, including 1 with cutaneous T-cell
lymphoma (CTCL) and 1 with peripheral T-cell lymphoma (PTCL) at
DL2, and 10 with solid tumors at DL1-4. One partial response was
reported after 2 cycles in the CTCL patient at DL2, and stable
disease was reported after 2 cycles in 3 solid tumor patients
treated at DL3 and DL4. Safety and PD were consistent with previous
updates. Additional details will be available at 9:00 a.m. today
when the ASH abstracts are released.
- In the third quarter of 2023, the U.S. Food and Drug
Administration granted Fast Track designation to KT-333 for the
treatment of both relapsed/refractory CTCL and relapsed/refractory
PTCL.
KT-253 MDM2 Degrader
- The Company announced that the
KT-253 Phase 1 trial has completed enrollment to the first 2 dose
levels of Arm A (solid tumors and lymphomas) with enrollment to DL3
ongoing, achieving clinical proof-of-mechanism and initial
anti-tumor activity. Enrollment to Arm B (high grade myeloid
malignancies, including AML) has recently commenced, and Kymera
intends to present data from the KT-253 Phase 1 clinical trial at a
medical meeting in 2024. In Arm A as of the October 20, 2023 data
cut-off date:
- A total of 9 solid tumor patients
enrolled across DL1 (n=3), DL2 (n=4) and DL3 (n=2) have received a
mean of 2.3 cycles (range 1-6), with initial PD available for both
DL1 and DL2 while clinical response data are available only for
DL1.
- Dose-responsive target engagement
demonstrated in DL1 and DL2 through upregulation of GDF15, a
downstream plasma biomarker of p53 activation.
- A patient in DL1 with
relapsed/refractory Merkel cell carcinoma had a confirmed partial
response (PR) after 4 cycles with treatment continuing after 6
cycles; a second patient in DL1 with fibromyxoid sarcoma had
confirmed stable disease (SD) after 4 cycles and then came off
study after 6 cycles; a third patient in DL1 with uveal melanoma
progressed after 1 cycle of therapy.
- No dose-limiting toxicities across
DL1-3, with Grade 1/2 nausea and Grade 1 diarrhea being the most
common drug-related adverse events observed in 2 or more patients.
One patient at DL1 had a serious adverse event of Grade 3
hypotension during Cycle 4 that was due to diminished oral intake.
Treatment for the hypotension included IV fluids and the patient
was able to continue on study without a dose reduction or
recurrence of this adverse event. There were no neutropenia or
thrombocytopenia adverse events, even in patients who had received
up to 6 cycles of therapy.
- The Company expects to present
comprehensive preclinical and clinical translational data across
liquid and solid tumors that will inform a patient stratification
strategy for KT-253 in ongoing and future clinical studies at a
medical meeting in 2024.
- The Company presented preclinical
data at the 10th International MDM2 Workshop on its KT-253 MDM2
degrader program, demonstrating durable tumor regressions in Acute
Myeloid Leukemia (AML) models as a monotherapy and in combination
with the standard of care agent venetoclax.
- At the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics,
preclinical data from the Company’s collaborator at Dana-Farber
Cancer Institute was shared demonstrating in vitro efficacy of an
MDM2 degrader against Merkel cell carcinoma cell lines and
patient-derived cell lines that was achieved with brief exposures
and was superior to an MDM2 inhibitor, supporting MDM2 degradation
as a promising therapeutic approach in Merkel cell carcinoma.
KT-413 IRAKiMID Degrader
- While data continue to be
encouraging with respect to target knockdown in blood and
tolerability, Kymera will discontinue development of KT-413 for
strategic reasons and focus resources to support its growing
immunology pipeline.
Corporate Updates
- Kymera plans to hold a virtual
Immunology R&D Day on January 4, 2024. The R&D Day will
focus on its emerging pipeline of high-value immunology programs
which target proven biologic pathways, including new target
disclosures, supporting preclinical data and timing to clinical
studies initiation.
Program Background Information
For more information on Kymera’s pipeline visit our website:
https://www.kymeratx.com/pipeline/.
Conference Call
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 2023.
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 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 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 X (previously 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 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)(Unaudited) |
|
|
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) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
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 |
|
Investor
Contact: 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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