Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing targeted protein degradation to
deliver novel small molecule protein degrader medicines, today
reported business highlights and financial results for the second
quarter ended June 30, 2022.
“Kymera has made strong progress, dosing patients in our three
first-in-class clinical programs and advancing our mission to build
a fully integrated medicines company,” said Nello Mainolfi, PhD,
Co-Founder, President and CEO. “We are on track to deliver clinical
data before year end for all three programs, including our KT-474
Phase 1 patient cohort, where we expect to demonstrate the ability
of KT-474 to degrade IRAK4 and impact disease relevant biomarkers
in the skin and blood of HS and AD patients. We also plan to share
initial safety and proof-of-mechanism data for our two oncology
programs, KT-413 and KT-333. With a cash runway into 2025, we are
well-financed and poised to deliver clinical results in the second
half of this year that reinforce the exciting and broad potential
of our targeted protein degradation pipeline and platform.”
Business Highlights and Recent Developments
IRAK4 Degrader Program (KT-474)
Background. KT-474 is designed as a potent,
highly selective, orally bioavailable IRAK4 degrader, in
development for the treatment of IL-1R/TLR-driven autoimmune and
autoinflammatory diseases with high unmet medical needs. In 2021,
Kymera completed dose escalation in the single ascending dose (SAD)
and multiple ascending dose (MAD) portions of its KT-474 Phase 1
trial, the industry’s first randomized, placebo-controlled trial in
healthy adult volunteers for a heterobifunctional degrader
drug. The data demonstrated near complete IRAK4 degradation in
peripheral blood mononuclear cells (PBMC) and skin, robust
inhibition of multiple ex vivo-stimulated disease-relevant
cytokines, and a favorable safety profile. Kymera is collaborating
with Sanofi on the development of degrader candidates targeting
IRAK4, including KT-474 (SAR444656), outside of the oncology and
immuno-oncology fields.
Recent Updates. Kymera has commenced dosing patients in the
Phase 1 patient cohort (Part C). Part C is an open-label study of
KT-474 administered daily on an outpatient basis for 28 days. This
cohort is expected to enroll up to 20 patients with
moderate-to-severe hidradenitis suppurativa (HS) or atopic
dermatitis (AD) to examine the safety and
pharmacokinetics/pharmacodynamics (PK/PD) of KT-474 and explore
early signs of clinical activity of this first-in-class degrader
therapeutic. Patients will receive a daily dose of 75 mg of KT-474
with food. This dose is expected to provide a plasma exposure that
is approximately equivalent to that achieved with the 100 mg per
day dose in the fasted state in healthy volunteers in the MAD
portion of the trial, which showed maximal or close to maximal
degradation in blood and skin and broad disease relevant cytokine
inhibition ex vivo.
More information on the Phase 1 study can be found at
www.clinicaltrials.gov, identifier NCT04772885.
Expected 2022 Milestones:
- Present clinical data from patient cohort in HS and AD patients
(4Q22)
- Deliver data package to Sanofi for decision to proceed to Phase
2 (4Q22)
STAT3 Degrader Program (KT-333)
Background. A target long considered “undruggable,” STAT3 is a
transcriptional regulator that has been linked to numerous cancers
and other inflammatory and autoimmune diseases. Kymera is
developing selective STAT3 degraders for the treatment of
hematological malignancies and solid tumors, as well as autoimmune
and fibrotic diseases. The Company’s STAT3 degraders have the
potential to provide a transformative solution to address multiple
STAT3-dependent pathologies.
Recent Updates. Patient enrollment and dosing are ongoing in a
Phase 1 clinical trial of KT-333 evaluating the safety,
tolerability, PK/PD and clinical activity of KT-333 in adult
patients with relapsed and/or refractory lymphomas and solid
tumors. The first stage of the study will explore escalating doses
of KT-333 in a broad variety of tumor types. The second stage is
expected to consist of expansion cohorts to further characterize
the safety, tolerability, PK/PD and antitumor activity of KT-333 in
relapsed and/or refractory peripheral T-cell lymphoma (PTCL),
cutaneous T-cell lymphoma (CTCL), large granular lymphocytic
leukemia (LGL-L), and solid tumors.
KT-333 was recently granted Orphan drug designation by the U.S.
Food and Drug Administration for the treatment of PTCL. This
designation provides incentives to encourage the development of
medicines for rare diseases.
Expected 2022 Milestones:
- Present KT-333 clinical patient data, including initial safety
and proof-of-mechanism (4Q22)
IRAKIMiD Degrader Program (KT-413)
Background. Kymera is developing novel heterobifunctional
degraders that target degradation of both IRAK4 and IMiD
substrates, Ikaros and Aiolos, with a single small molecule. KT-413
is designed to address both the IL-1R/TLR and the Type 1 IFN
pathways synergistically to broaden activity against MYD88-mutant B
cell malignancies.
Recent Updates. Patient enrollment and dosing are ongoing in a
Phase 1 clinical trial of KT-413 evaluating the safety,
tolerability, PK/PD and antitumor activity of KT-413 in patients
with relapsed and/or refractory B-cell non-Hodgkin's lymphomas. The
first stage will explore escalating doses of single-agent KT-413 in
a broad B-cell lymphoma population. The second stage is expected to
consist of expansion cohorts to further characterize the safety,
tolerability, PK/PD and antitumor activity of KT-413 in
relapsed/refractory MYD88-mutant diffuse large B cell lymphoma
(DLBCL).
Expected 2022 Milestones:
- Present KT-413 clinical patient data, including initial safety
and proof-of-mechanism (4Q22)
MDM2 Degrader Program (KT-253)
Background and Update. MDM2 is the crucial regulator of the most
common tumor suppressor, p53, which remains intact (WT) in more
than 50% of cancers. Kymera is developing a highly potent MDM2
degrader that, unlike small molecule inhibitors, has been shown
preclinically to have the ability to suppress the MDM2 feedback
loop and rapidly induce apoptosis, even with brief exposures.
KT-253 has the potential to be effective in a wide range of
hematological malignancies and solid tumors with functioning (WT)
p53. Kymera is completing IND enabling studies for KT-253 and
expects to file an IND in 2H22.
Expected 2022 Milestones:
- File IND for KT-253 (2H22)
- Present preclinical translational data to inform long-term
clinical strategy (2H22)
Platform and Discovery Programs
Background. 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. Multiple programs are approaching
development stage in 2022 from its discovery pipeline with at least
one using a tissue restricted E3 ligase.
New Appointments
Kymera recently announced the appointment of Leigh Morgan to its
Board of Directors. Ms. Morgan is a senior executive accomplished
in scaling global, high-performing organizations in the
biopharmaceutical, non-profit, and public sectors. In her current
role as Chief Strategy and Operating Officer for Nia Tero, she is a
key architect of the firm’s growth, inclusive of strategy, finance,
innovation, communications, operations, impact investments and
governance. Ms. Morgan previously served as Chief Operating Officer
of the Bill & Melinda Gates Foundation where she oversaw a
broad portfolio, including human resources, information technology
and security, facilities and the foundation’s culture
transformation efforts. Her health and biotechnology leadership
roles include serving as Associate Chancellor at the University of
California, San Francisco, Vice President and Global Head of Human
Resources for Product Development at Genentech, and HR leadership
roles at GSK. She currently serves as Vice-Chair/Chair-elect of the
Board at the Fred Hutch Cancer Center, is on the University of
Washington Medical Center Advisory Board, and is an independent
director at Curemark, a clinical-stage biotechnology
company.
Conference Call
To access the conference call via phone, please dial
877-317-6789 (U.S.) or +1 412-317-6789 (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 for one month following
the event.
Second Quarter 2022 Financial Results
Collaboration Revenues: Collaboration revenues
were $11.5 million for the second quarter of 2022 compared to $18.5
million the second quarter of 2021. Collaboration revenues include
revenue from the Company’s Sanofi and Vertex collaborations.
Research and Development Expenses: Research and
development expenses were $41.3 million for the second quarter of
2022 compared to $35.2 million for the second quarter of 2021. This
increase was primarily due to direct expenses related to clinical
activities for our IRAK4, IRAKIMiD, and STAT3 programs, as well as
increased expenses related to the investment in our MDM2 program,
platform, discovery programs, and Vertex collaboration, 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 $4.8 million and
$2.9 million in the second quarter of 2022 and the second quarter
of 2021, respectively.
General and Administrative Expenses: General
and administrative expenses were $11.0 million for the second
quarter of 2022, compared to $8.0 million for the second quarter of
2021. This increase was primarily due to increases 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 our growth. Stock based
compensation expenses included in G&A were $4.9 million and
$2.8 million in the second quarter of 2022 and the second quarter
of 2021, respectively.
Net Loss: Net loss was $40.3 million for the
second quarter of 2022 compared to a net loss of $24.7 million for
the second quarter of 2021.
Cash and Cash Equivalents: As of June 30, 2022,
Kymera had approximately $482.5 million in cash, cash equivalents,
and investments. Kymera expects that its cash, cash equivalents,
excluding any future potential milestones from collaborations, will
enable the Company to fund its operational plans into 2025 while
the Company 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 therapies candidates 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 intractable of
pathways and provide new treatments for patients. Kymera’s initial
programs target IRAK4, IRAKIMiD, and STAT3 within the IL-1R/TLR or
JAK/STAT pathways, providing the opportunity to treat patients with
a broad range of immune-inflammatory diseases, hematologic
malignancies, and solid tumors. For more information, visit
www.kymeratx.com.
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 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 clinical trials; the ability to initiate new
clinical programs; and cash position and expected runway. 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 future 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; 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, 2021 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 30,2022 |
|
December 31,2021 |
Assets |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
482,491 |
|
$ |
567,605 |
Property and equipment,
net |
|
|
12,748 |
|
|
11,881 |
Other assets |
|
|
28,182 |
|
|
26,419 |
Total assets |
|
$ |
523,421 |
|
$ |
605,905 |
Liabilities and
Stockholders’ Equity |
|
|
|
|
Deferred revenue |
|
$ |
83,531 |
|
$ |
101,034 |
Other liabilities |
|
|
41,939 |
|
|
45,233 |
Total liabilities |
|
|
125,470 |
|
|
146,267 |
Total stockholders’ equity |
|
|
397,951 |
|
|
459,638 |
Total liabilities and stockholders’ equity |
|
$ |
523,421 |
|
$ |
605,905 |
KYMERA THERAPEUTICS,
INC.Consolidated Statements of
Operations(In thousands, except share and per
share amounts)(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months EndedJune 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration Revenue—from related parties |
|
$ |
11,514 |
|
|
$ |
18,519 |
|
|
$ |
21,136 |
|
|
$ |
37,221 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
41,293 |
|
|
$ |
35,220 |
|
|
$ |
77,238 |
|
|
$ |
61,181 |
|
General
and administrative |
|
|
11,031 |
|
|
|
8,029 |
|
|
|
21,642 |
|
|
|
13,939 |
|
Total
operating expenses |
|
|
52,324 |
|
|
|
43,249 |
|
|
|
98,880 |
|
|
|
75,120 |
|
Loss
from operations |
|
|
(40,810 |
) |
|
|
(24,730 |
) |
|
|
(77,744 |
) |
|
|
(37,899 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
Interest and other income |
|
|
594 |
|
|
|
98 |
|
|
|
884 |
|
|
|
217 |
|
Interest and other expense |
|
|
(41 |
) |
|
|
(28 |
) |
|
|
(81 |
) |
|
|
(53 |
) |
Total other income |
|
|
553 |
|
|
|
70 |
|
|
|
803 |
|
|
|
164 |
|
Net loss
attributable to common stockholders |
|
$ |
(40,257 |
) |
|
$ |
(24,660 |
) |
|
$ |
(76,941 |
) |
|
$ |
(37,735 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.49 |
) |
|
$ |
(0.84 |
) |
Weighted
average common stocks outstanding, basic and diluted |
|
|
51,772,440 |
|
|
|
45,094,238 |
|
|
|
51,712,081 |
|
|
|
44,873,083 |
|
Investor Contacts:Bruce JacobsChief Financial
Officerinvestors@kymeratx.com857-285-5300
Chris BrinzeyManaging Director,
Westwickechris.brinzey@westwicke.com339-970-2843
Media Contact:Todd CooperSenior Vice President,
Corporate Affairstcooper@kymeratx.com
Kymera Therapeutics (NASDAQ:KYMR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Kymera Therapeutics (NASDAQ:KYMR)
Historical Stock Chart
From Jul 2023 to Jul 2024