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 fourth quarter and full year ended
December 31, 2023, and provided business highlights and updates on
its pipeline of protein degraders.
“In 2023, we made significant progress with our industry-leading
degrader portfolio, reinforcing the potential of targeted protein
degradation to have a meaningful impact on patient’s lives. Our
ability to deliver reproducible and differentiated innovation has
been demonstrated across multiple programs and disease areas
including KT-474, KT-333 and KT-253, all advancing in clinical
testing. Furthermore, with the expansion of our first-in-class
immunology pipeline with our STAT6 and TYK2 programs, we have the
potential to revolutionize the treatment of many
immuno-inflammatory diseases using oral degrader medicines with the
potential for biologics-like activity,” said Nello Mainolfi, PhD,
Founder, President and CEO, Kymera Therapeutics.
Dr. Mainolfi continued, “Looking ahead, we’re excited to further
demonstrate the advantages that our technology and platform have
shown over traditional medicines and the utility of this unique
mechanism across different disease contexts. We are well
capitalized to execute on our strategy and invest in our
best-in-industry pipeline and are energized by the opportunity to
deliver on our vision and, most importantly, improve patients’
lives.”
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 patients
were dosed in both trials in the fourth quarter of 2023. Under the
terms of the Sanofi/Kymera collaboration, the dosing of the first
patients generated milestone payments totaling $55 million.
Enrollment in both trials is ongoing, with topline data expected to
be reported in the first half of 2025.
- In November, Kymera published the KT-474 Phase 1 trial results
in Nature Medicine, showing robust target knockdown and pathway
inhibition in healthy volunteers and reduction of disease-relevant
inflammatory biomarkers in the blood and skin of HS and AD patients
associated with improvement in skin lesions and symptoms.
KT-621 STAT6 Degrader
- Kymera unveiled its first-in-class
oral STAT6 degrader, KT-621, at its Immunology R&D Day in
January. STAT6 is a transcription factor specific for the
IL-4/IL-13 signaling pathway that drives Type 2 inflammation in
allergic diseases. In Kymera’s preclinical testing, KT-621
selectively and potently degraded STAT6 and fully blocked the
IL-4/IL-13 pathway with preclinical activity in human cells and
animal models equal or superior to the monoclonal antibody
targeting IL-4Rα, dupilumab, thereby demonstrating broad potential
across a number of dermatologic, respiratory and gastrointestinal
allergic diseases.
- The Company plans to share
additional preclinical data at upcoming medical meetings, expects
to initiate a Phase 1 clinical trial in the second half of 2024 and
report the Phase 1 results in 2025.
KT-294 TYK2 Degrader
- Kymera unveiled its first-in-class
oral TYK2 degrader, KT-294, at its Immunology R&D Day in
January. TYK2 is a member of the Janus Kinase (JAK) family required
for Type I interferon, IL-12 and IL-23 signaling with both genetic
and clinical validation in autoimmune and inflammatory diseases.
KT-294 selectively and potently degrades TYK2, phenocopying the
inhibition of Type I interferon, IL-12 and IL-23 signaling seen in
humans with TYK2 loss of function mutations, while sparing IL-10
signaling needed for gastrointestinal epithelial integrity and
mucosal healing. This profile has the potential to circumvent the
limitations of both selective and non-selective TYK2 small molecule
inhibitors, providing a best-in-class opportunity in several
indications including inflammatory bowel disease, lupus and
psoriasis.
- The Company plans to share
additional preclinical data at upcoming medical meetings, expects
to initiate a Phase 1 clinical trial in the first half of 2025 and
report the Phase 1 results in 2025.
KT-333 STAT3 Degrader
- At the American Society of Hematology (ASH) Annual Meeting in
December, Kymera reported interim data from the KT-333 Phase 1
clinical trial through an October 18, 2023 cut-off, demonstrating
early signs of antitumor activity at doses that were generally
well-tolerated and associated with substantial STAT3 knockdown in
blood and tumor. An interferon gamma signature predictive of
sensitivity to anti-PD-1 therapy was induced in the tumor biopsy of
a cutaneous T-cell lymphoma (CTCL) patient following treatment on
the Phase 1 study, indicating the potential of KT-333 to synergize
with PD-1 antibody therapy. The Phase 1a dose escalation portion of
the clinical trial is ongoing.
- The Company expects to complete the Phase 1a study and share
additional proof-of-concept data to inform the program’s next
development steps in 2024. These data are expected to be presented
at a medical meeting.
KT-253 MDM2 Degrader
- In November, the Company shared
preliminary data from the KT-253 Phase 1 clinical trial, as of a
data cut-off of October 20, 2023, from the first 2 dose levels of
Arm A (solid tumors and lymphomas) with enrollment to dose level 3
ongoing. The data demonstrated evidence of target engagement and
p53 pathway activation, as well as initial antitumor activity and a
lack of the traditional hematological toxicity seen with small
molecule inhibitors. Kymera is also developing a biomarker-based
patient selection strategy for subsequent development beyond Phase
1a. Enrollment to Arm B in high grade myeloid malignancies,
including AML, is underway.
- The Company expects to complete the Phase 1a study and share
additional proof-of-concept data to inform the program’s next
development steps at a medical meeting in 2024.
Corporate Updates
- In January, the Company announced
the closing of its upsized underwritten equity offering. Kymera
intends to use the approximately $301 million net proceeds from the
offering to continue to advance its pipeline of preclinical and
clinical degrader programs that are designed to address large
patient populations with significant need and clear commercial
opportunity, and for working capital and other general corporate
purposes. With cash of approximately $745 million as of January 9,
2024, the Company is well-capitalized with an expected cash runway
into the first half of 2027.
- Kymera is relocating its corporate
headquarters in Watertown, MA, to support the growing organization
and scale critical research and development capabilities to enable
the expansion and progress of the Company’s innovative pipeline
into areas that address large clinical and commercial
opportunities.
Program Background Information
For more information on Kymera’s pipeline visit our website.
Financial Results
Collaboration Revenues: Collaboration revenues
were $47.9 million for the fourth quarter of 2023 and $78.6 million
for the year ended December 31, 2023, compared to $16.1 million and
$46.8 million, respectively, for the same periods of 2022.
Collaboration revenues in the fourth quarter of 2023 include
revenue from the Company’s Sanofi collaboration, including revenue
related to the recognition of the recently achieved Phase 2
milestones.
Research and Development Expenses: Research and
development expenses were $53.0 million for the fourth quarter of
2023 and $189.1 million for the year ended December 31, 2023,
compared to $43.1 million and $164.2 million, respectively, for the
same periods of 2022. This increase was primarily due to increased
expenses related to the investment in the Company’s 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 R&D
were $5.3 million for the fourth quarter of 2023 and $21.6 million
for the year ended December 31, 2023, compared to $4.5 million and
$18.0 million, respectively, for the same periods in 2022.
General and Administrative Expenses: General
and administrative expenses were $14.2 million for the fourth
quarter of 2023 and $55.0 million for the year ended December 31,
2023, compared to $11.6 million and $43.8 million, respectively,
for the same periods of 2022. The increase in annual expense was
primarily due to 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 G&A were $5.6 million for the
fourth quarter of 2023 and $21.6 million for the year ended
December 31, 2023, compared to $4.4 million and $17.5 million,
respectively, for the same periods in 2022.
Net Loss: Net loss was $14.4 million for the
fourth quarter of 2023 and $147.0 million for the year ended
December 31, 2023, compared to a net loss of $34.9 million and
$154.8 million, respectively, for the same periods of 2022.
Cash and Cash Equivalents: As of January 9,
2024, Kymera had approximately $745 million in cash, cash
equivalents, and investments. Kymera expects that its cash and cash
equivalents, which include the net proceeds from the sale of common
stock and pre-funded warrants in a public offering on January 4,
2024, of approximately $301 million, will provide the Company with
an anticipated cash runway into the first half of 2027. 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, and several clinical inflection points for its
STAT6 and TYK2 programs while Kymera continues to identify
opportunities to accelerate growth and expand its pipeline,
technologies and clinical indications.
Conference Call
Kymera will host a conference call and webcast today, February
22, 2024, at 8:30 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 News and Events 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 for
three months.
1Unaudited, estimated cash as of January 9, 2024, inclusive of
approximately $301 million of net proceeds from the company’s
recently-closed equity offering and a $15 million payment received
from Sanofi for a Phase 2 dosing milestone achieved in the fourth
quarter of 2023.
About Kymera TherapeuticsKymera is a
clinical-stage biotechnology company pioneering the field of
targeted protein degradation (TPD) to develop medicines that
address critical health problems and have the potential to
dramatically improve patients’ lives. Kymera is deploying TPD to
address disease targets and pathways inaccessible with conventional
therapeutics. Having advanced the first degrader into the clinic
for immunological diseases, Kymera is focused on delivering oral
small molecule degraders to provide a new generation of convenient,
highly effective therapies for patients with these conditions.
Kymera is also progressing degrader oncology programs that target
undrugged or poorly drugged proteins to create new ways to fight
cancer. Founded in 2016, Kymera has been recognized as one of
Boston’s top workplaces for the past several years. For more
information about our science, pipeline and people, please visit
www.kymeratx.com or follow us on X (previously Twitter) or
LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements This 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 its clinical
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 2027. 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; 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, including those for
KT-474 (SAR444656), KT-621, KT-294, KT-333 and KT-253; 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,
2023, 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, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
436,315 |
|
$ |
559,494 |
Property and equipment,
net |
|
48,134 |
|
|
13,334 |
Right-of-use assets, operating
lease |
|
52,945 |
|
|
8,909 |
Other assets |
|
38,365 |
|
|
21,397 |
Total assets |
$ |
575,759 |
|
$ |
603,134 |
Liabilities and
Stockholders’ Equity |
|
|
|
Deferred revenue |
$ |
54,651 |
|
$ |
63,260 |
Operating lease
liabilities |
|
82,096 |
|
|
14,681 |
Other liabilities |
|
44,041 |
|
|
35,042 |
Total liabilities |
|
180,788 |
|
|
112,983 |
Total stockholders’
equity |
|
394,971 |
|
|
490,151 |
Total liabilities and
stockholders’ equity |
$ |
575,759 |
|
$ |
603,134 |
|
|
|
|
|
|
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, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Collaboration Revenue—from related parties |
$ |
47,884 |
|
|
$ |
16,139 |
|
|
$ |
78,592 |
|
|
$ |
46,826 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
52,970 |
|
|
$ |
43,133 |
|
|
$ |
189,081 |
|
|
$ |
164,248 |
|
General and administrative |
|
14,227 |
|
|
|
11,637 |
|
|
|
55,041 |
|
|
|
43,834 |
|
Total operating expenses |
|
67,197 |
|
|
|
54,770 |
|
|
|
244,122 |
|
|
|
208,082 |
|
Loss from operations |
|
(19,313 |
) |
|
|
(38,631 |
) |
|
|
(165,530 |
) |
|
|
(161,256 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest and other income |
|
4,996 |
|
|
|
3,824 |
|
|
|
18,764 |
|
|
|
6,624 |
|
Interest and other expense |
|
(52 |
) |
|
|
(58 |
) |
|
|
(196 |
) |
|
|
(176 |
) |
Total other income |
|
4,944 |
|
|
|
3,766 |
|
|
|
18,568 |
|
|
|
6,448 |
|
Net loss attributable to common
stockholders |
$ |
(14,369 |
) |
|
$ |
(34,865 |
) |
|
$ |
(146,962 |
) |
|
$ |
(154,808 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.25 |
) |
|
$ |
(0.60 |
) |
|
$ |
(2.52 |
) |
|
$ |
(2.87 |
) |
Weighted average common stocks
outstanding, basic and diluted |
|
58,521,837 |
|
|
|
57,889,273 |
|
|
|
58,365,499 |
|
|
|
53,933,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media
Contact: Justine KoenigsbergVice President, Investor
Relationsinvestors@kymeratx.commedia@kymeratx.com857-285-5300 |
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