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, 2021.
“This month marks Kymera’s five-year anniversary, going from
idea generation to clinical entry, and now towards becoming a fully
integrated, best-in-class degrader medicines company,” said Nello
Mainolfi, PhD, Co-Founder, President and CEO of Kymera
Therapeutics. “This year, we have launched the first randomized,
placebo-controlled Phase 1 trial with a heterobifunctional degrader
in healthy volunteers and patients with immune-inflammatory
diseases and are on our way to advancing our two lead degrader
programs in oncology into the clinic, while expanding our pipeline
of novel protein degraders and continuing to broaden our platform
and organizational capabilities.”
Program Updates and MilestonesKymera is
discovering and developing novel small molecule therapeutics
designed to selectively degrade disease-causing proteins by
harnessing the body’s own natural protein degradation system, with
an initial focus on immune-inflammatory diseases and oncology.
IRAK4 Degrader ProgramIRAK4 is a key protein
involved in inflammation mediated by the activation of toll-like
receptors (TLRs) and IL-1 receptors (IL-1Rs). Aberrant activation
of these pathways is the underlying cause of multiple
immune-inflammatory conditions. KT-474, a potential first-in-class,
orally bioavailable IRAK4 degrader, is being developed for the
treatment of TLR/IL-1R-driven immune-inflammatory diseases with
high unmet medical need, such as atopic dermatitis, hidradenitis
suppurativa, rheumatoid arthritis, and potentially others. KT-474
is designed to block TLR/IL-1R-mediated inflammation more broadly
compared to monoclonal antibodies targeting single cytokines, and
to enable pathway inhibition that is superior to IRAK4 kinase
inhibitors by abolishing both the kinase and scaffolding functions
of IRAK4.
Recent Updates:
- In February 2021, Kymera initiated dosing of healthy volunteers
in a first-in-human Phase 1 single and multiple ascending dose
trial designed to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of orally administered
KT-474 in adult healthy volunteers and patients with atopic
dermatitis or hidradenitis suppurativa.
- In May 2021, Kymera presented new data evaluating levels of
IRAK4 and inflammatory biomarkers in patients with hidradenitis
suppurativa from its non-interventional study of patients with
hidradenitis suppurativa or atopic dermatitis. The data
demonstrated that IRAK4 protein levels were overexpressed in
hidradenitis suppurativa skin compared to the skin of healthy
subjects, and that transcripts for multiple mediators of
inflammation were upregulated in hidradenitis suppurativa skin
lesions, correlating with IRAK4 protein overexpression as measured
by mass spectrometry or immunofluorescence. KT-474 inhibited
TLR-stimulated upregulation of hidradenitis
suppurativa-overexpressed inflammatory genes in monocytes from
healthy subjects. These data provide further evidence for the
central role of IRAK4 in the pleiotropic inflammation in
hidradenitis suppurativa and support the rationale for targeting
IRAK4 with the IRAK4 degrader KT-474. The data were presented in a
late-breaking poster session at the Society for Investigative
Dermatology 2021 Annual Meeting.
- A late-breaking abstract featuring new preclinical data
demonstrating KT-474’s superiority to small molecule IRAK4 kinase
inhibitors across immune-inflammatory preclinical models, titled
“IRAK4 degradation abrogates cytokine release and improves disease
endpoints in murine models of IL-33/36- as well as Th17-driven
inflammation,” was recently accepted for presentation at the at the
American Association of Immunologists’ Virtual IMMUNOLOGY2021™,
taking place May 10-15, 2021.
Expected Milestones:
- Presentation of KT-474 preclinical data at the American
Association of Immunologists’ Virtual IMMUNOLOGY2021™ annual
meeting (May 2021)
- Initiation of enrollment in multiple ascending dose portion of
Phase 1 trial of KT-474 pending FDA clearance, including healthy
volunteers and a subsequent cohort of patients with atopic
dermatitis or hidradenitis suppurativa (2H21)
- Establish Phase 1 proof-of-biology in healthy volunteers
(4Q21)
IRAKIMiD Degrader ProgramIRAKIMiDs are novel
heterobifunctional degraders designed to degrade both IRAK4 and
IMiD substrates, including Ikaros and Aiolos, with a single small
molecule. IRAKIMiDs synergistically target both the MYD88-NFkB and
IRF4-Type 1 interferon pathways to enhance and broaden anti-tumor
activity in multiple contexts, such as MYD88-mutant diffuse large
B-cell lymphoma (DLBCL). KT-413 is being developed initially for
the treatment of relapsed/refractory MYD88-mutant DLBCL, with the
potential to expand into other MYD88-mutant indications and
IL-1R/NFkB-driven malignancies. In preclinical studies, KT-413 has
demonstrated a potential first-in-class profile as a targeted
therapy for MYD88-mutant DLBCL, including strong single-agent
antitumor activity against MYD88-mutant lymphomas in vitro and in
mouse xenograft models derived from lymphoma cell lines and patient
tumors, which has led to rapid, complete, and sustained tumor
regressions. Kymera plans to submit an Investigational New Drug
Application (IND) to the FDA and, if cleared, initiate a Phase 1
clinical trial in relapsed/refractory B cell lymphomas, including
MYD88-mutant DLBCL, in the second half of 2021.
Recent Updates:
- In April 2021, Kymera presented new preclinical data showing
how the dual targeting of IRAK4 and IMiD substrates by KT-413
synergizes to impact signaling and cell killing in MYD88-mutant
DLBCL in a manner that is distinct from IMiDs or selective IRAK4
targeting alone. The data were presented in a late-breaking poster
session at the American Association of Cancer Research (AACR)
Annual Meeting 2021.
Expected Milestones:
- Submission of KT-413 IND application, and if cleared,
initiation of Phase 1 clinical trial in relapsed/refractory B cell
lymphomas, including MYD88-mutant DLBCL (2H21)
- Presentation of additional KT-413 preclinical data and
potential indication expansion strategies (2H21)
- Establish Phase 1 proof-of-biology and initial clinical
proof-of-concept in patients (2022)
STAT3 Degrader ProgramKymera is developing
selective STAT3 degraders for the treatment of hematological
malignancies and solid tumors, as well as autoimmune diseases and
fibrosis. STAT3 is a transcription factor activated through a
variety of different cytokine and growth factor receptors via Janus
kinases (JAKs), as well as through oncogenic fusion proteins and
mutations in STAT3 itself. Long considered an undruggable target,
STAT3 hyperactivation is prominent in numerous liquid and solid
tumors, including clinically aggressive lymphomas. Kymera’s potent
and selective STAT3 degraders have demonstrated strong anti-tumor
effects in mouse xenograft and syngeneic models of liquid and solid
tumors.
Recent Updates:
- In February 2021, Kymera nominated KT-333 as a STAT3
development candidate for liquid and solid tumor indications and
the Company has initiated IND-enabling activities. KT-333 has
demonstrated high potency and selectivity in both in vitro and in
vivo preclinical models, including significant and sustained
anti-tumor activity in several preclinical models of liquid and
solid tumors.
Expected Milestones:
- Presentation of additional preclinical data in liquid and solid
tumors (2H21)
- Submission of KT-333 IND application, and if cleared,
initiation of Phase 1 clinical trial in relapsed/refractory liquid
and solid tumors (4Q21)
- Establish Phase 1 proof-of-biology and initial clinical
proof-of-concept in patients (2022)
Platform and Discovery ProgramsKymera is also
actively advancing a broad pipeline of preclinical programs across
a wide variety of diseases, both internally and in collaboration
with existing partners Vertex Pharmaceuticals and Sanofi. The
internal programs continue to be focused on undrugged or
inadequately drugged nodes within highly validated pathways in
immune-inflammatory and oncology indications. Kymera is also
developing a new generation of tissue-selective or -restrictive
degrader medicines with the goal of drugging an entirely new set of
protein targets.
Expected Milestones:
- Presentation on Kymera’s Pegasus™ platform with updates on the
identification of a tissue-selective E3 ligase demonstrating
degradation across multiple cancer and immune cell types, by Chris
De Savi, PhD, Vice President, Head of Drug Discovery at Kymera, at
the inaugural Ligase Targeting Drug Development Summit taking place
on May 25 - 27, 2021
- Continue pipeline expansion by advancing discovery programs
toward IND-enabling studies
Corporate Updates
- In March 2021, the Company appointed Elena Ridloff, CFA to its
Board of Directors and as Chair of the Audit Committee. Ms. Ridloff
joins Kymera’s Board with two decades of biopharmaceutical industry
experience, including senior leadership positions at
commercial-stage companies and as an institutional investor.
- In April 2021, the Boston Business Journal named Kymera
Therapeutics to its 2021 Best Places to Work, an exclusive ranking
of the Massachusetts companies that have built outstanding work
environments for their people.
- In May 2021, Kymera appointed Juliet Williams, PhD, as Senior
Vice President, Head of Biology. Dr. Williams joins Kymera with 20
years of drug development experience, including service at
Novartis, Sanofi, Millennium, and Curis.
- Kymera plans to host its inaugural R&D Day in 2H21 to
unveil its next pathway/programs approaching clinical development,
as well as to outline the Company’s vision and goals for the next
five years.
First Quarter 2021 Financial
ResultsCollaboration Revenues:
Collaboration revenues were $18.7 million for the first quarter of
2021, compared to $3.4 million for the same period of 2020.
Collaboration revenues include revenue from our Sanofi and Vertex
collaborations.
Research and Development Expenses: Research and
development expenses were $26.0 million for the first quarter of
2021, compared to $12.1 million for the same period of 2020. This
increase was primarily due to expenses related to IND-enabling
studies and clinical activities for our IRAK4 and IRAKIMiD
programs, lead optimization activities for our STAT3 program,
investments in our platform and exploratory programs, the Vertex
collaboration, as well as an increase in occupancy and related
costs due to continued growth in the research and development
organization.
General and Administrative Expenses: General
and administrative expenses were $5.9 million for the first quarter
of 2021, compared to $2.6 million for the same period of 2020. 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 growth as a public company.
Net Loss: Net loss was $13.1 million for the
first quarter of 2021, compared to a net loss of $10.9 million for
the same period of 2020.
Cash and Cash Equivalents: As of March 31,
2021, Kymera had approximately $435.2 million in cash, cash
equivalents, and investments. Kymera expects that its cash, cash
equivalents, and investments as of December 31, 2020, 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 Therapeutics
(Nasdaq: KYMR) is a clinical-stage biopharmaceutical company
founded with the mission to discover, develop, and commercialize
transformative therapies while leading the evolution of targeted
protein degradation, a transformative new approach to address
previously intractable disease targets. Kymera’s Pegasus™ platform
enables the discovery of novel small molecule degraders designed to
harness the body’s natural protein recycling machinery to degrade
disease-causing proteins, with a focus on undrugged nodes in
validated pathways currently inaccessible with conventional
therapeutics. Kymera’s initial programs are IRAK4, IRAKIMiD, and
STAT3, each of which addresses high impact targets within the
IL-1R/TLR or JAK/STAT pathways, providing the opportunity to treat
a broad range of immune-inflammatory diseases, hematologic
malignancies, and solid tumors. Kymera’s goal is to be a fully
integrated biopharmaceutical company at the forefront of this new
class of protein degrader medicines, with a pipeline of novel
degrader medicines targeting disease-causing proteins that were
previously intractable.
Founded in 2016, Kymera is headquartered in Watertown, Mass.
Kymera has been named a “Fierce 15” biotechnology company by
FierceBiotech and has been recognized by the Boston Business
Journal as one of Boston’s “Best Places to Work.” For more
information about our people, science, and pipeline, please visit
www.kymeratx.com or follow us on Twitter or LinkedIn.
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 regarding its: strategy, business
plans and objectives for the IRAK4, IRAKIMiD and STAT3 degrader
programs; and plans and timelines for the clinical development of
Kymera Therapeutics' product candidates, including the therapeutic
potential and clinical benefits thereof. 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
preclinical studies and future clinical trials, strategy and future
operations; the delay of any current preclinical studies or future
clinical trials or the development of Kymera
Therapeutics' drug candidates; the risk that the results
of current preclinical studies 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
Company’s planned interactions with regulatory authorities,
including the resolution of the current partial clinical hold for
KT-474; and obtaining, maintaining and protecting its intellectual
property. These and other risks and uncertainties are
described in greater detail in the section entitled "Risk Factors"
in the Annual Report on Form 10-Q for the period ended March 31,
2021, expected to be filed on or about May 6, 2021, 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.
Investors:Paul CoxVP, Investor Relations and
Communicationspcox@kymeratx.com917-754-0207
Media:Lissette L. SteeleVerge Scientific
Communications for Kymera
Therapeuticslsteele@vergescientific.com202-930-4762
KYMERA THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In
thousands)(Unaudited)
|
|
March 31,2021 |
|
|
December 31,2020 |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
435,176 |
|
|
$ |
458,733 |
|
Property and equipment,
net |
|
|
10,752 |
|
|
|
10,841 |
|
Other assets |
|
|
18,624 |
|
|
|
17,601 |
|
Total assets |
|
$ |
464,552 |
|
|
$ |
487,175 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Deferred revenue |
|
$ |
152,566 |
|
|
$ |
170,390 |
|
Other liabilities |
|
|
36,739 |
|
|
|
32,897 |
|
Total liabilities |
|
|
189,305 |
|
|
|
203,287 |
|
Total stockholders’ equity |
|
|
275,247 |
|
|
|
283,888 |
|
Total liabilities and
stockholders’ equity |
|
$ |
464,552 |
|
|
$ |
487,175 |
|
KYMERA THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(In thousands,
except for share and per share
amounts)(Unaudited)
|
|
Three Months
EndedMarch 31, |
|
|
2021 |
|
|
2020 |
|
Collaboration Revenue—from related parties |
|
$ |
18,702 |
|
|
|
3,428 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
25,962 |
|
|
$ |
12,116 |
|
General and
administrative |
|
|
5,909 |
|
|
|
2,559 |
|
Total operating expenses |
|
|
31,871 |
|
|
|
14,675 |
|
Loss from operations |
|
|
(13,169 |
) |
|
|
(11,247 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest Income |
|
|
118 |
|
|
|
349 |
|
Interest Expense |
|
|
(24 |
) |
|
|
(34 |
) |
Total other income: |
|
|
94 |
|
|
|
315 |
|
Net loss |
|
$ |
(13,075 |
) |
|
$ |
(10,932 |
) |
Deemed dividend from exchange
of convertible preferred stock |
|
|
— |
|
|
|
(9,050 |
) |
Net loss attributable to
common stockholders |
|
$ |
(13,075 |
) |
|
$ |
(19,982 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.29 |
) |
|
$ |
(10.23 |
) |
Weighted average common stocks
outstanding, basic and diluted |
|
|
44,649,572 |
|
|
|
1,952,667 |
|
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