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 first
quarter ended March 31, 2022.
“Kymera has made continued progress in the first quarter against
our goals to build a fully integrated degrader medicines company,”
said Nello Mainofi, PhD, Co-Founder, President and CEO. “With three
active clinical programs, 2022 promises to be a year rich in data
and milestones that build upon our prior scientific achievements.
Of note, we anticipate sharing initial safety and
proof-of-mechanism data for our two oncology programs, KT-413 and
KT-333, and filing an IND for our MDM2 program, KT-253, in the
second half of 2022. Additionally, we have finalized the dose
selection and amended the design of the KT-474 Phase 1 patient
cohort to include 28 days of dosing, which is now expected to
deliver additional key de-risking data in 2H22. With a robust
pre-clinical pipeline complementing our clinical stage programs,
and a cash runway into 2025, we remain well-positioned to deliver
at least one new clinical program per year, thus broadening the
potential clinical and eventual commercial impact of our
pipeline.”
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 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 selected the equivalent of 100 mg, in
the fed state, as the dose for the Phase 1 patient cohort (Part C),
which is expected to enroll up to 20 total patients with
hidradenitis suppurativa (HS) and atopic dermatitis (AD). In
alignment with the U.S. Food and Drug Administration (FDA) and
partner Sanofi, the Part C protocol has been amended to extend the
dosing period from 14 to 28 days. In addition to pharmacokinetics
(PK) and pharmacodynamics (PD) data, including key inflammatory
biomarker readouts in both skin and plasma, this change will allow
for the exploration of clinical endpoints in both HS and AD
patients, as well as an extended safety dataset. Clinical endpoints
to be evaluated include Eczema Area and Severity Index (EASI) for
AD, total abscess and inflammatory nodule count for HS, as well as
additional measures of symptoms and physician or investigator
global assessments for both diseases. 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 (2H22)
- Deliver data package
to Sanofi for decision to proceed to Phase 2 (2H22)
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. KT-333 is being evaluated in an
ongoing Phase 1 trial in adult patients with certain
relapsed/refractory liquid and solid tumors, including aggressive
lymphomas.
Recent Updates. In 4Q of 2021, Kymera received IND clearance
from FDA for KT-333, its first-in-class STAT3 degrader. The first
clinical site was activated in 1Q22, and patient recruitment is
underway. Dose escalation is expected throughout 2022, with data
available later this year.
Expected 2022 Milestones:
- Present patient
data, including initial safety and proof-of-mechanism clinical
data, to de-risk further development (2H22)
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. KT-413 is being evaluated in an ongoing Phase 1
trial in adult patients with relapsed/refractory B cell lymphomas,
including MYD88-mutant diffuse large B cell lymphoma (DLBCL).
Recent Updates. In 4Q of 2021, Kymera received IND clearance
from FDA for KT-413, its first-in-class IRAKIMiD degrader. The
first clinical site was activated in 1Q22, and patient recruitment
is underway. Dose escalation is expected throughout 2022, with data
available later this year
Expected 2022 Milestones:
- Present patient
data, including initial safety and proof-of-mechanism clinical
data, to de-risk further development (2H22)
MDM2 Degrader Program (KT-253)
Background. 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 can 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.
Recent Updates. In 4Q of 2021, Kymera nominated KT-253, its
first-in-class MDM2 degrader, as development candidate. KT-253 is
currently in IND enabling activities to support an IND filing in
2H22. In April, the Company presented preclinical data highlighting
the biological superiority of MDM2 degradation over inhibition at
the American Association for Cancer Research (AACR) Annual Meeting
in New Orleans, LA. KT-253 demonstrated extremely potent in vitro
cell killing and in vivo anti-tumor activity with intermittent
dosing that is superior to data reported for existing small
molecule inhibitors and indicates the potential for improved
efficacy, safety, and broader clinical utility.
Expected 2022 Milestones:
- File IND for KT-253
(2H22)
- Present new
preclinical data elucidating indication expansion strategies
(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.
Recent Updates. In April 2022, Kymera delivered multiple
presentations at the 2nd Annual Ligase Targeting Drug Development
Summit, focusing on the disclosure of a novel liganded E3 ligase
now part of Kymera’s expanding E3 ligase toolbox and unveiling, for
the first time, Kymera’s broad approach to selecting and validating
ligandability, biology, and expression of novel E3 ligases.
New Appointments
Earlier this year, the Company announced the appointment of John
Maraganore, Ph.D. to its Board of Directors. Dr. Maraganore joins
Kymera’s Board after having led Alnylam Pharmaceuticals as founding
CEO and Director and transformed the field of RNA therapeutics for
the last nearly 20 years. Dr. John Maraganore served as the
founding CEO and a Director of Alnylam from 2002 to 2021, where he
built and led the company from early platform research on RNA
interference through global approval and commercialization of the
first four RNAi therapeutic medicines, ONPATTRO®, GIVLAARI®,
OXLUMO®, and Leqvio®.
Recently, Kymera appointed Todd Cooper to lead communications
and corporate affairs. Cooper joins Kymera from Sanofi, where he
led internal and external communications that enhanced the global
pharmaceutical company’s scientific reputation, highlighted the
company’s pipeline across all media types and engaged the R&D
organization globally.
Conference CallTo access the conference call
via phone, please dial 833-740-0921 (U.S.) or +1 409-937-8885
(International) and use the conference ID 2984916. 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.
First Quarter 2022 Financial Results
Collaboration Revenues: Collaboration revenues
were $9.6 million for the first quarter of 2022 compared to $18.7
million the first quarter of 2021. Collaboration revenues include
revenue from the Company’s Sanofi and Vertex collaborations.
Research and Development Expenses: Research and
development expenses were $35.9 million for the first quarter of
2022 compared to $26.0 million for the first 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 programs,
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 $3.9 million and
$1.7 million in the first quarter of 2022 and the first quarter of
2021, respectively.
General and Administrative Expenses: General
and administrative expenses were $10.6 million for the first
quarter of 2022, compared to $5.9 million for the first 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 $4.0 million and
$1.4 million in the first quarter of 2022 and the first quarter of
2021, respectively.
Net Loss: Net loss was $36.7 million for the
first quarter of 2022 compared to a net loss of $13.1 million for
the first quarter of 2021.
Cash and Cash Equivalents: As of March 31,
2022, Kymera had $523.3 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)
|
March 31,2022 |
|
December 31,2021 |
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
23,290 |
|
|
$ |
567,605 |
|
Property and equipment,
net |
|
11,759 |
|
|
|
11,881 |
|
Other assets |
|
28,011 |
|
|
|
26,419 |
|
Total assets |
$ |
563,060 |
|
|
$ |
605,905 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Deferred revenue |
$ |
92,675 |
|
|
$ |
101,034 |
|
Other liabilities |
|
41,665 |
|
|
|
45,233 |
|
Total liabilities |
|
134,340 |
|
|
|
146,267 |
|
Total stockholders’ equity |
|
428,720 |
|
|
|
459,638 |
|
Total liabilities and stockholders’ equity |
$ |
563,060 |
|
|
$ |
605,905 |
|
KYMERA THERAPEUTICS,
INC.Consolidated Statements of
Operations(In thousands, except share and per
share amounts)(Unaudited)
|
Three Months EndedMarch 31, |
|
|
2022 |
|
|
|
2021 |
|
Collaboration Revenue—from
related parties |
$ |
9,622 |
|
|
$ |
18,702 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development |
$ |
35,944 |
|
|
$ |
25,962 |
|
General and administrative |
|
10,611 |
|
|
|
5,909 |
|
Total operating expenses |
|
46,555 |
|
|
|
31,871 |
|
Loss from operations |
|
(36,933 |
) |
|
|
(13,169 |
) |
Other income (expense): |
|
|
|
Interest and other income |
|
290 |
|
|
|
118 |
|
Interest and other expense |
|
(41 |
) |
|
|
(24 |
) |
Total other income |
|
249 |
|
|
|
94 |
|
Net loss |
$ |
(36,684 |
) |
|
$ |
(13,075 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.71 |
) |
|
$ |
(0.29 |
) |
Weighted average common stocks
outstanding, basic and diluted |
|
51,651,125 |
|
|
|
44,649,572 |
|
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
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