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 fourth
quarter and full year ended December 31, 2021.
“2021 was a breakthrough year for Kymera as we achieved numerous
milestones on our path to becoming a fully integrated,
best-in-class degrader medicines company,” said Nello Mainolfi,
PhD, Co-Founder, President and CEO, Kymera Therapeutics. “With the
clearance of two INDs late in 2021, we now have three clinical
stage programs targeting both immune inflammatory and oncology
indications, all of which are expected to generate key de-risking
patient data in 2022. Combined with a differentiated platform and
powerful drug discovery engine poised to generate at least one new
IND per year, Kymera is well-positioned to deliver on our goals and
impact patients around the globe with a new generation of degrader
therapies.”
2021 Business Highlights and Recent
Developments
- Completed dose escalation in the healthy volunteer portion of
KT-474 Phase 1 trial, and presented SAD and MAD data demonstrating
near complete IRAK4 knockdown in PBMC and skin, as well as robust
ex vivo inhibition of multiple disease-relevant cytokines with a
favorable safety profile
- INDs cleared and Phase 1 clinical studies initiated for KT-333
and KT-413
- Disclosed new development program, KT-253, a potent and
selective degrader of MDM2 for a broad variety of liquid and solid
tumor indications, with IND filing planned for 2H22
- Disclosed, for the first-time, in vivo proof-of-concept of
tissue selective degradation utilizing a tissue- restricted E3
ligase in a program expected to enter development in 2H22
- Established a novel molecular glue discovery effort focused on
rationally developing novel E3 ligase-based molecular glues,
including collaborations with A-Alpha Bio and pioneers at the
University of Washington and NYU
- Hosted first R&D Day in December 2021, highlighting
near-term goals and 5-year vision to build a global biotech company
with a disease- and technology-agnostic pipeline
- Appointed biotech pioneer John Maraganore, Ph.D., to the
Company’s Board of Directors in January 2022
- Ended 2021 with cash of approximately $568 million, including
gross proceeds of $257 million from a completed follow-on financing
in July 2021, providing a cash runway into 2025
Key 2022 Milestones
IRAK4 Degrader Program (KT-474) KT-474 is a
potent, highly selective, orally bioavailable IRAK4 degrader, for
the treatment of IL-1R/TLR-driven conditions and diseases with high
unmet medical need, including hidradenitis suppurativa (HS), atopic
dermatitis (AD), rheumatoid arthritis (RA) and potentially several
other diseases. 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 volunteers for a
heterobifuctional degrader drug. The data demonstrated near
complete IRAK4 degradation in PBMC and skin, robust ex vivo
inhibition of multiple disease-relevant cytokines and a favorable
safety profile. The final portion of the trial will enroll patients
with hidradenitis suppurativa and atopic dermatitis.Expected
Milestones:
- Present data from patient cohort showing proof of mechanism and
proof of biology (2H22)
- Subsequently initiate Ph2
studies
Kymera is collaborating with Sanofi on the development of
degrader candidates targeting IRAK4, including KT-474 (SAR444656),
outside of the oncology and immune-oncology fields.
STAT3 Degrader Program (KT-333)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. In 4Q of 2021,
Kymera received IND clearance from FDA for KT-333, its
first-in-class STAT3 degrader, which is now in Ph1 clinical studies
in patients with liquid and solid tumors.
Expected Milestones:
- Present first patient proof of mechanism clinical data to
de-risk further development (2022)
- Present new preclinical data to enable indication expansions in
new oncology indications (2022)
IRAKIMiD Degrader Program (KT-413)Kymera is
developing novel heterobifunctional degraders that target
degradation of both IRAK4 and IMiD substrates Ikaros and Aiolos
with a single small molecule, addressing both the IL-1R/TLR and the
Type 1 IFN pathways synergistically to broaden activity against
MYD88-mutant DLBCL. In 4Q of 2021, Kymera received IND clearance
from FDA for KT-413, its first-in-class IRAKIMiD degrader, which is
now in Ph1 clinical studies in patients with lymphomas.
Expected Milestones:
- Present first patient proof of mechanism clinical data to
de-risk further development (2022)
- Present new preclinical data to enable indication expansions in
new oncology indications (2022)
MDM2 Degrader Program (KT-253) 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 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. In 4Q of 2021, Kymera nominated KT-253, its first-in-class
MDM2 degrader as development candidate, which is now in IND
enabling activities.
Expected Milestones
- Present additional preclinical data that outline the biomarker
strategy as well as new indications for KT-253 (2022)
- File IND for KT-253 (2H22)
Platform and Discovery ProgramsKymera 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.
Expected Milestones:
- Nominate the Company’s first Development Candidate using a
tissue restricted E3 ligase (2H22)
- Continue pipeline expansion by advancing early-stage discovery
programs toward IND-enabling studies
- Further expand the capabilities of Kymera’s Pegasus™ platform
to identify the optimal pairing of disease-causing protein targets
with E3 ligases to generate novel degrader product candidates
- Leverage Kymera’s E3 Ligase Whole-Body Atlas of over 600 unique
E3 ligases to identify previously unliganded E3 ligases, including
tissue-restricted or -selective, as well as new small molecule
molecular glue degraders to unlock new opportunities across broad
therapeutic applications
- Advance multiple molecular glue programs in optimization
Fourth Quarter and Full Year 2021 Financial
Results
Collaboration Revenues: Collaboration revenues
were $15.3 million for the fourth quarter of 2021 and $72.8 million
for the year ended December 31, 2021, compared to $12.8 million and
$34.0 million, respectively, for the same periods of 2020.
Collaboration revenues include revenue from the Company’s Sanofi
and Vertex collaborations.
Research and Development Expenses: Research and
development expenses were $37.5 million for the fourth quarter of
2021 and $137.0 million for the year ended December 31, 2021,
compared to $20.4 million and $62.1 million, respectively, for the
same periods of 2020. These increases were primarily due to direct
expenses related to IND-enabling studies and clinical activities
for 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. Research and development
expenses included non-cash stock-based compensation expense of $3.7
million for the fourth quarter of 2021 and $11.7 million for the
year ended December 31, 2021, compared to $1.0 million and $2.3
million, respectively, for the same periods in 2020.
General and Administrative Expenses: General
and administrative expenses were $11.7 million for the fourth
quarter of 2021 and $36.3 million for the year ended December 31,
2021, compared to $5.2 million and $18.2 million, respectively, for
the same periods of 2020. These increases were 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 growth
as a public company. General and administrative expenses included
non-cash stock-based compensation expense of $5.0 million for the
fourth quarter of 2021 and $13.2 million for the year ended
December 31, 2021, compared to $0.9 million and $2.9 million,
respectively, for the same periods in 2020.
Net Loss: Net loss was $33.9 million for the
fourth quarter of 2021 and $100.2 million for the year ended
December 31, 2021, compared to a net loss of $12.7 million and
$45.6 million, respectively, for the same periods of 2020.
Cash and Cash Equivalents: As of December 31,
2021, Kymera had approximately $567.6 million in cash, cash
equivalents, and investments. Kymera expects that its cash, cash
equivalents, and investments as of December 31, 2021, 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 that 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
therapeutics 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 2022 and beyond,
including 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; and expectations regarding its existing
collaborations. 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, filed on February 24, 2022, 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)
|
December 31, |
|
|
2021 |
|
|
2020 |
Assets |
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
567,605 |
|
$ |
458,733 |
Property and equipment,
net |
|
11,881 |
|
|
10,841 |
Other assets |
|
26,419 |
|
|
17,601 |
Total assets |
$ |
605,905 |
|
$ |
487,175 |
Liabilities and
Stockholders’ Equity |
|
|
|
Deferred revenue |
$ |
101,034 |
|
$ |
170,390 |
Other liabilities |
|
45,233 |
|
|
32,897 |
Total liabilities |
|
146,267 |
|
|
203,287 |
Total stockholders’ equity |
|
459,638 |
|
|
283,888 |
Total liabilities and stockholders’ equity |
$ |
605,905 |
|
$ |
487,175 |
KYMERA THERAPEUTICS, INC.
Consolidated Statements of Operations and
Comprehensive Loss(In thousands, except share and
per share amounts)(Unaudited)
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Collaboration Revenue—from
related parties |
$ |
15,275 |
|
|
$ |
12,785 |
|
|
$ |
72,832 |
|
|
$ |
34,034 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
37,530 |
|
|
$ |
20,392 |
|
|
$ |
137,017 |
|
|
$ |
62,105 |
|
General and
administrative |
|
11,740 |
|
|
|
5,175 |
|
|
|
36,345 |
|
|
|
18,233 |
|
Total operating expenses |
|
49,270 |
|
|
|
25,567 |
|
|
|
173,362 |
|
|
|
80,338 |
|
Loss from operations |
|
(33,995 |
) |
|
|
(12,782 |
) |
|
|
(100,530 |
) |
|
|
(46,304 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest and other income |
|
144 |
|
|
|
124 |
|
|
|
488 |
|
|
|
826 |
|
Interest and other expense |
|
(50 |
) |
|
|
(27 |
) |
|
|
(175 |
) |
|
|
(115 |
) |
Total other income |
|
94 |
|
|
|
97 |
|
|
|
313 |
|
|
|
711 |
|
Net loss |
$ |
(33,901 |
) |
|
$ |
(12,685 |
) |
|
$ |
(100,217 |
) |
|
$ |
(45,593 |
) |
Deemed dividend from exchange
of convertible preferred stock |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(9,050 |
) |
Net loss attributable to
common stockholders |
$ |
(33,901 |
) |
|
$ |
(12,685 |
) |
|
$ |
(100,217 |
) |
|
$ |
(54,643 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.66 |
) |
|
$ |
(0.29 |
) |
|
$ |
(2.09 |
) |
|
$ |
(3.15 |
) |
Weighted average common stocks
outstanding, basic and diluted |
|
51,394,065 |
|
|
|
44,467,228 |
|
|
|
47,989,023 |
|
|
|
17,349,582 |
|
Investor Contact:Bruce JacobsChief Financial
Officerinvestors@kymeratx.com857-285-5300
Chris BrinzeyManaging Director,
Westwickechris.brinzey@westwicke.com339-970-2843
Media Contact:Tyler GagnonDirector, Corporate
Communicationstgagnon@kymeratx.com508-904-9446
Kymera Therapeutics (NASDAQ:KYMR)
Historical Stock Chart
From Jul 2024 to Aug 2024
Kymera Therapeutics (NASDAQ:KYMR)
Historical Stock Chart
From Aug 2023 to Aug 2024