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 third quarter ended September 30, 2024,
and provided business highlights and updates on its pipeline of
first- and best-in-class protein degraders.
“This has been an important year for Kymera with an increased
focus on the exciting opportunities we have in immunology and
programs that have the potential to transform the treatment
landscape for millions of patients around the globe,” said Nello
Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “We
are particularly excited about the initiation of the Phase 1 trial
for KT-621, our first-in-class STAT6 degrader. This is a target
that perfectly fits the value proposition of oral degraders with
biologics-like activity, and we are excited and proud to be the
first company to advance a drug candidate for this mechanism into
the clinic. The preclinical profile of KT-621 is compelling,
particularly its ability to replicate the biology of upstream
biologics like dupilumab, which we look forward to translating in
the clinic with an initial Phase 1 data readout in the first half
of 2025. In addition, Sanofi’s decision to expand both the HS and
AD studies with KT-474 into dose ranging Phase 2b studies is a
testament to their strong interest in exploring even more
comprehensively the IRAK4 degradation mechanism and this drug
candidate given all the supporting data generated so far.”
Dr. Mainolfi added, “Given the significant progress and
potential of our immunology pipeline, we have made the decision to
shift our resources toward our discovery and development efforts in
immunology. As a result, we will advance our clinical stage
oncology programs beyond Phase 1 only in the context of a
partnership. Focusing our resources and efforts on our work in
immunology reflects our financial discipline around program
prioritization to address large patient populations with
significant need and clear substantial commercial
opportunities.”
Business Highlights, Recent Developments and Upcoming
Milestones
STAT6 Degrader Program
KT-621 is an investigational, first-in-class, once daily, oral
degrader of STAT6, the specific transcription factor responsible
for IL-4/IL-13 signaling and the central driver of TH2
inflammation, currently in Phase 1 testing. In preclinical studies,
KT-621 was well tolerated with exquisite selectivity and fully
blocked IL-4/IL-13 functions in key human TH2 cellular assays and
in in vivo models of TH2 inflammation with comparable or superior
activity to dupilumab. KT-621 has the potential to address numerous
TH2 diseases including atopic dermatitis, asthma and COPD, among
others.
- In October, Kymera initiated dosing
in the Phase 1 healthy volunteer clinical trial evaluating single
and multiple ascending doses of KT-621, a potent and selective oral
degrader of STAT6. The Phase 1 trial will evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of KT-621
compared to placebo. The Company expects to report Phase 1 data in
the first half of 2025. More information on the KT-621 Phase 1
study will be available on www.clinicaltrials.gov.
- The Company presented preclinical
data at the European Academy of Dermatology and Venereology (EADV)
Congress and the American College of Asthma, Allergy, and
Immunology (ACAAI) Annual Meeting. The new findings showed strong
degradation of STAT6 in human sensory neurons resulted in
inhibition of IL-13-induced itch- and pain-related gene
transcripts, highlighting the potential of KT-621 to alleviate
these symptoms in atopic dermatitis patients by effectively
targeting and modulating the STAT6 pathway.
IRAK4 Degrader ProgramKT-474 (SAR444656) is an
investigational, first-in-class, once daily, oral degrader of
IRAK4, a key protein involved in inflammation. Phase 2 clinical
trials for hidradenitis suppurativa (HS) and atopic dermatitis
(AD), in collaboration with Sanofi, are currently ongoing. In
the Phase 1 study, KT-474 demonstrated robust degradation of IRAK4
in the blood and skin of healthy volunteers and patients with HS
and AD, demonstrating a systemic anti-inflammatory effect and
preliminary evidence of clinical activity.
- In July, Kymera announced that
Sanofi had communicated to Kymera the intent to expand the ongoing
KT-474 Phase 2 trials in HS and AD following an interim review of
KT-474/SAR444656 safety and efficacy data by an independent data
monitoring committee. The expansion of the ongoing HS and AD Ph2
studies to larger dose-ranging Phase 2b studies is intended to
accelerate overall development timelines and enable a subsequent
transition into registrational Phase 3 trials.
- Hidradenitis Suppurativa
(ZEN trial): The study has been expanded from 99 to 156
patients. Previously, the trial included one active dose of KT-474
as well as placebo. The study will now include an additional dose.
The estimated primary completion date for the ZEN trial is now in
the first half of 2026.
- Atopic Dermatitis (ADVANTA
Trial): The study has been expanded from 115 to 200
patients. Previously, the trial included two active doses of KT-474
as well as placebo. The study will now include an additional dose.
The estimated primary completion date for the ADVANTA trial is now
in the middle of 2026.
- In July, results from the Company’s
non-interventional trial evaluating IRAK4 expression in patients
with HS were published in the Journal of Investigative Dermatology.
The results support the role of IRAK4 signaling in HS and the
potential of IRAK4 degradation to impact the clinical
manifestations of HS, AD, and potentially other TLR/IL-1R-driven
immuno-inflammatory diseases.
- In August, the Company published on
the discovery of KT-474 in the Journal of Medicinal Chemistry
highlighting the exploration of structure–activity relationships
that ultimately led to the identification of the first-in-class
oral IRAK4 degrader, KT-474, and reinforcing Kymera’s innovative
molecular design strategies.
TYK2 Degrader Program
KT-295 is an investigational, first-in-class, once daily, oral
degrader of TYK2, a member of the Janus kinase (JAK) family
required for Type I IFN, IL-12 and IL-23 signaling. In preclinical
studies, unlike traditional small molecule inhibitors, KT-295 has
demonstrated picomolar degradation potency and potent inhibition of
the IL-23, IL-12 and Type I IFN pathways while sparing IL-10,
showing its potential to recapitulate the biology of human TYK2
loss-of-function mutations. KT-295 has the potential to be the
first oral therapy to deliver biologics-like activity in diseases
such as IBD and psoriasis, among others.
- The Company nominated a new TYK2
development candidate, KT-295, a potent, selective, once daily oral
degrader, and has prioritized this compound for clinical
evaluation. KT-295 has picomolar potency and is highly selective
for TYK2, while also demonstrating greater in vivo activity in
preclinical animal models compared to KT-294, the Company’s
previously identified TYK2 degrader.
- Kymera intends to advance KT-295 into Phase 1 clinical testing
in the first half of 2025, which is consistent with prior program
guidance. The Company expects to report Phase 1 data later that
year.
Oncology Degrader Programs
- Dose escalation and enrollment have
been completed for both the KT-333 and KT-253 Phase 1 trials. Based
on an overall assessment of its clinical oncology programs, and
given progress across the immunology pipeline, the Company has made
the strategic decision not to continue development of KT-333
(STAT3) and KT-253 (MDM2) beyond Phase 1. Kymera plans to present
STAT3 Phase 1 data at a poster presentation at ASH in December. The
Company is evaluating partnership opportunities to advance the
oncology pipeline beyond its current stage.
Corporate Updates
- In August, the Company announced the
closing of an upsized underwritten equity offering, resulting in
net proceeds of approximately $247 million. With these proceeds,
the Company extended its cash runway into mid-2027.
Program Background Information
For more information on Kymera’s pipeline visit our website.
Financial Results
Collaboration Revenues: Collaboration revenues
were $3.7 million for the third quarter of 2024, compared to $4.7
million for the same period of 2023. Collaboration revenues in the
third quarter of 2024 were all attributable to the Company’s Sanofi
collaboration.
Research and Development Expenses: Research and
development expenses were $60.4 million for the third quarter of
2024, compared to $48.1 million for the same period of 2023. This
increase was primarily due to increased expenses related to the
investment in the Company’s STAT6 degrader program, 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 $7.6 million for the third quarter of 2024, compared to $5.8
million for the same period in 2023.
General and Administrative Expenses: General
and administrative expenses were $15.5 million for the third
quarter of 2024, compared to $14.1 million for the same period of
2023. The increase was primarily due to an increase in legal and
professional service fees in support of the Company’s growth and an
increase in personnel, facility, occupancy, and other expenses to
support growth as a public company. Stock based compensation
expenses included in G&A were $7.3 million for the third
quarter of 2024 compared to $5.9 million for the same period in
2023.
Net Loss: Net loss was $62.5 million for the
third quarter of 2024 compared to a net loss of $52.9 million for
the same period of 2023.
Cash and Cash Equivalents: As of September 30,
2024, Kymera had $911 million in cash, cash equivalents, and
investments. Kymera expects that its cash and cash equivalents will
provide the Company with an anticipated cash runway into mid-2027.
Its existing cash is expected to take the Company beyond the Phase
2 data for KT-474 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, October
31, 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.
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 building an
industry-leading pipeline of oral small molecule degraders to
provide a new generation of convenient, highly effective therapies
for patients with these conditions. 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 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 about our expectations regarding
strategy, business plans and objectives on the clinical development
of clinical and preclinical pipeline, Sanofi’s
expansion of the Phase 2 clinical trials of KT-474/SAR444656, the
initiation of a Phase 1 clinical trial of KT-621 and expected
initial data readout of KT-621 in the first half of 2025, the
declaration of KT-295 as a development candidate and the decision
not to advance KT-333 and KT-253 beyond Phase 1 without a partner
and Kymera’s financial condition and expected cash runway into
mid-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 any
forward-looking statements contained in this press release,
including, without limitation, risks associated with: uncertainties
inherent in the initiation, timing and design of future clinical
trials, the availability and timing of data from ongoing and future
clinical trials and the results of such trials, whether preliminary
results of early clinical trials will be indicative of the results
of later clinical trials, the ability to successfully demonstrate
the safety and efficacy of drug candidates, the timing and outcome
of planned interactions with regulatory authorities, the
availability of funding sufficient for our operating expenses and
capital expenditure requirements and other factors. These risks and
uncertainties are described in greater detail in the section
entitled "Risk Factors" in the most recent Quarterly Report on Form
10-Q and in subsequent filings with the Securities and Exchange
Commission. In addition, any forward-looking statements represent
our views only as of today and should not be relied upon as
representing our views as of any subsequent date. We explicitly
disclaim 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) |
|
|
|
|
|
September 30, 2024 |
|
December 31, 2023 |
|
Assets |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
911,005 |
|
$ |
436,315 |
|
| Property and
equipment, net |
|
|
51,244 |
|
|
48,134 |
|
| Right-of-use
assets, operating lease |
|
|
48,065 |
|
|
52,945 |
|
| Other assets |
|
|
24,528 |
|
|
38,365 |
|
|
Total assets |
|
$ |
1,034,842 |
|
$ |
575,759 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
| Deferred
revenue |
|
$ |
20,024 |
|
$ |
54,651 |
|
| Operating lease
liabilities |
|
|
85,144 |
|
|
82,096 |
|
| Other
liabilities |
|
|
36,744 |
|
|
44,041 |
|
| Total
liabilities |
|
|
141,912 |
|
|
180,788 |
|
| Total
stockholders’ equity |
|
|
892,930 |
|
|
394,971 |
|
| Total liabilities
and stockholders’ equity |
|
$ |
1,034,842 |
|
$ |
575,759 |
|
| |
|
KYMERA THERAPEUTICS, INC. |
|
Consolidated Statements of Operations and Comprehensive
Loss |
|
(In thousands, except share and per share
amounts) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
| |
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
Collaboration Revenue |
$ |
3,741 |
|
|
$ |
4,728 |
|
|
$ |
39,678 |
|
|
$ |
30,707 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
| Research
and development |
$ |
60,410 |
|
|
$ |
48,117 |
|
|
$ |
168,431 |
|
|
$ |
136,111 |
|
| General
and administrative |
|
15,455 |
|
|
|
14,120 |
|
|
|
47,202 |
|
|
|
40,814 |
|
|
Impairment of long-lived assets |
|
— |
|
|
|
— |
|
|
|
4,925 |
|
|
|
— |
|
| Total
operating expenses |
|
75,865 |
|
|
|
62,237 |
|
|
|
220,558 |
|
|
|
176,925 |
|
| Loss
from operations |
|
(72,124 |
) |
|
|
(57,509 |
) |
|
|
(180,880 |
) |
|
|
(146,218 |
) |
| Other
income (expense): |
|
|
|
|
|
|
|
|
Interest and other income |
|
9,697 |
|
|
|
4,683 |
|
|
|
27,964 |
|
|
|
13,768 |
|
|
Interest and other expense |
|
(60 |
) |
|
|
(41 |
) |
|
|
(190 |
) |
|
|
(144 |
) |
|
Total other income |
|
9,637 |
|
|
|
4,642 |
|
|
|
27,774 |
|
|
|
13,624 |
|
| Net loss
attributable to common stockholders |
$ |
(62,487 |
) |
|
$ |
(52,867 |
) |
|
$ |
(153,106 |
) |
|
$ |
(132,594 |
) |
| Net loss
per share attributable to common stockholders, basic and
diluted |
$ |
(0.82 |
) |
|
$ |
(0.90 |
) |
|
$ |
(2.09 |
) |
|
$ |
(2.27 |
) |
| Weighted average common stock
outstanding, basic and diluted |
|
76,125,975 |
|
|
|
58,421,859 |
|
|
|
73,330,338 |
|
|
|
58,312,813 |
|
| |
Investor & Media Contact:
Justine
Koenigsberginvestors@kymeratx.commedia@kymeratx.com857-285-5300
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