Kronos Bio Reports Recent Business Progress and Fourth-Quarter and Full-Year 2022 Financial Results
March 15 2023 - 4:05PM
Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to
transforming the lives of those affected by cancer, today reported
recent business progress and fourth-quarter and full-year 2022
financial results.
“We have had an exciting start to 2023, with both
the announcement of our discovery collaboration with Genentech and
the dosing of our first patient in the expansion cohort of our
Phase 1/2 study of KB-0742,” said Norbert Bischofberger, Ph.D.,
president and chief executive officer of Kronos Bio. “We look
forward to building upon this strong momentum and sharing
additional data from each of our clinical programs later this year
and over the course of 2024. KB-0742 has the potential to help
patients with a broad variety of solid tumors, and we anticipate
reporting initial efficacy data from that program in the second
half of this year. For lanraplenib, our Phase 1b/2 study in
combination with gilteritinib seeks to address a significant unmet
need in relapsed/refractory FLT3-mutated AML, and we anticipate
providing initial data and a recommended Phase 2 dose later this
year or early next year. We continue to focus on strong clinical
execution as we work to bring innovative therapies to patients with
cancer.”
Fourth Quarter and Recent Company
Updates
- KB-0742
- In December 2022, Kronos Bio announced that it had selected the
recommended phase 2 dose in its ongoing Phase 1/2 study of KB-0742
in solid tumors, after reaching the target engagement goal with an
acceptable safety profile. The analysis further showed that KB-0742
continues to demonstrate a differentiated pharmacokinetic (PK)
profile, with oral bioavailability, long half-life, and
dose-proportional exposure across all four dose levels, and low to
moderate variability between patients. The dose escalation portion
of the study is continuing with the goal of identifying the maximum
tolerated dose.
- The expansion portion of the trial is ongoing and includes
Cohort A, for patients with MYC-amplified tumors, such as triple
negative breast cancer, non-small cell lung cancer and ovarian
cancer; and Cohort B, for patients with transcriptionally addicted
cancers, including chordomas, sarcomas and small cell lung cancer.
Both cohorts are enrolling, and in early 2023, the company dosed
the first patient.
- Additional results from the dose escalation portion of the
Phase 1/2 study and initial efficacy data from expansion portion
are expected to be presented at a medical conference in the second
half of 2023.
- Lanraplenib
- In December 2022, the company presented preclinical data that
demonstrated anti-leukemic activity of lanraplenib in combination
with multiple targeted agents in patient-derived cell isolates and
cell lines at the 64th American Society of Hematology (ASH) Annual
Meeting & Exposition. These data further support the biological
rationale for SYK inhibition as a treatment for AML.
- Kronos Bio anticipates sharing initial data from the Phase 1b/2
study of lanraplenib in combination with gilteritinib in patients
with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML),
along with a recommended Phase 2 dose (RP2D), in the fourth quarter
of 2023 or first quarter of 2024.
- Discovery Collaboration with Genentech
- In January 2023, Kronos Bio announced that it had entered into
a discovery collaboration in the field of oncology with Genentech,
a member of the Roche Group, focused on discovering and developing
small-molecule drugs that modulate transcription factor targets
selected by Genentech. Kronos Bio will lead discovery and research
activities to a defined preclinical point when Genentech will have
the exclusive right to pursue further preclinical and clinical
development and commercialization.
- Under the terms of the agreement, Kronos Bio received an
upfront payment of $20 million and is eligible for additional
payments, which could total up to $554 million, based on reaching
certain milestones, including discovery, preclinical, clinical and
commercial milestones, as well as tiered royalties on any potential
products that are commercialized as a result of the
collaboration.
Fourth-Quarter and Full-Year 2022
Financial Highlights
- Cash, Cash Equivalents and Investments: With
its ongoing and currently planned clinical programs and $247.9
million in cash, cash equivalents and investments as of
December 31, 2022, the company anticipates sufficient
resources to fund its planned operations into the second half of
2025. In January 2023, the Company entered into a Collaboration and
License Agreement with Genentech, Inc., to initially collaborate on
two discovery research programs in oncology. Pursuant to the
Agreement, the Company received an upfront payment of $20.0 million
from Genentech.
- R&D Expenses: Research and development
expenses were $23.2 million for the fourth quarter of 2022, which
includes non-cash stock-based compensation expense of $3.6 million.
For the full year of 2022, research and development expenses were
$93.7 million, which includes non-cash stock-based compensation
expense of $15.0 million.
- G&A Expenses: General and administrative
expenses were $10.5 million for the fourth quarter of 2022, which
includes non-cash stock-based compensation expense of $4.1 million.
For the full year of 2022, general and administrative expenses were
$43.4 million, which includes non-cash stock-based compensation
expense of $16.2 million.
- Net Loss: Net loss for the fourth quarter of
2022 was $31.8 million, or $0.56 per share, including non-cash
stock-based compensation of $7.7 million. Net loss for the
full-year 2022 was $133.2 million, or $2.37 per share, including
non-cash stock-based compensation expense of $31.1 million.
About Kronos Bio, Inc.
Kronos Bio is a biopharmaceutical company that is
advancing two investigational compounds in clinical trials for
patients with cancer. The company is developing the CDK9 inhibitor
KB-0742 as a treatment for MYC-amplified solid tumors and other
transcriptionally addicted solid tumors and lanraplenib, a
next-generation SYK inhibitor, for patients with FLT3-mutated acute
myeloid leukemia. The company’s scientific focus is on developing
medicines that target the dysregulated transcription that is the
hallmark of cancer and other serious diseases.
Kronos Bio is based in San Mateo, Calif., and has
a research facility in Cambridge, Mass. For more information, visit
www.kronosbio.com or follow the company on LinkedIn.
Forward-Looking Statements
Statements in this press release that are not
statements of historical fact are forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. The press release, in some cases,
uses terms such as “anticipate,” “expect,” “look forward to,”
“potential” or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding Kronos
Bio’s intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things, the potential
of KB-0742, the anticipated reporting of initial efficacy data for
KB-0742 and the timing thereof, the anticipated providing of
initial data and a recommended Phase 2 dose for lanraplenib and the
timing thereof, Kronos Bio’s expectations for providing data for
each of its clinical programs over the course of 2024, activities
and potential milestones under the discovery collaboration with
Genentech, Kronos Bio’s expected cash runway, and other statements
that are not historical fact. Actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties, including, without limitation: whether Kronos Bio
will be able to progress its clinical trials on the timeline
anticipated, including due to risks inherent in the clinical
development of novel therapeutics; risks related to Kronos Bio’s
lack of experience as a company in conducting clinical trials;
risks related to discovery and preclinical development activities,
as well as risks associated with collaborations with third parties;
the risk that results of preclinical studies and early clinical
trials are not necessarily predictive of future results; and risks
associated with the sufficiency of Kronos Bio’s cash resources and
need for additional capital. These and other risks are described in
greater detail in Kronos Bio’s filings with the Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in its Quarterly Report on Form 10-Q for the quarter ended
September 30, 2022, filed with the SEC on November 8, 2022, and its
Annual Report on Form 10-K for the year ended December 31, 2022,
being filed with the SEC later today. Any forward-looking
statements that are made in this press release speak only as of the
date of this press release and are based on management’s
assumptions and estimates as of such date. Except as required by
law, Kronos Bio assumes no obligation to update the forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Investors: Claudia Styslinger
Argot Partners 212-600-1902 kronosbio@argotpartners.com
Media: Leo Vartorella/David Rosen
Argot Partners 212-600-1494 kronosbio@argotpartners.com
Kronos Bio, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts) (Unaudited)
|
Three Months
Ended December 31, |
|
Year EndedDecember 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
23,168 |
|
|
$ |
50,819 |
|
|
$ |
93,715 |
|
|
$ |
112,903 |
|
General and administrative |
|
10,514 |
|
|
|
11,587 |
|
|
|
43,400 |
|
|
|
38,495 |
|
Total
operating expenses |
|
33,682 |
|
|
|
62,406 |
|
|
|
137,115 |
|
|
|
151,398 |
|
Loss from
operations |
|
(33,682 |
) |
|
|
(62,406 |
) |
|
|
(137,115 |
) |
|
|
(151,398 |
) |
Other income
(expense), net: |
|
|
|
|
|
|
|
Interest and other income, net |
|
1,900 |
|
|
|
72 |
|
|
|
3,911 |
|
|
|
320 |
|
Total other
income (expense), net |
|
1,900 |
|
|
|
72 |
|
|
|
3,911 |
|
|
|
320 |
|
Net
loss |
|
(31,782 |
) |
|
|
(62,334 |
) |
|
|
(133,204 |
) |
|
|
(151,078 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
Net unrealized loss on available-for-sale securities |
|
258 |
|
|
|
(46 |
) |
|
|
(753 |
) |
|
|
(20 |
) |
Net
comprehensive loss |
$ |
(31,524 |
) |
|
$ |
(62,380 |
) |
|
$ |
(133,957 |
) |
|
$ |
(151,098 |
) |
Net loss per
share, basic and diluted |
$ |
(0.56 |
) |
|
$ |
(1.13 |
) |
|
$ |
(2.37 |
) |
|
$ |
(2.76 |
) |
Weighted-average number of shares used to compute net loss per
share, basic and diluted |
|
56,522,785 |
|
|
|
55,358,508 |
|
|
|
56,201,398 |
|
|
|
54,753,599 |
|
Kronos Bio, Inc.
Selected Balance Sheet Data (in thousands, except
share and per share amounts) (Unaudited)
|
December 31, 2022 |
|
December 31, 2021 |
Cash, cash equivalents and investments |
$ |
247,947 |
|
$ |
339,509 |
Total
assets |
|
294,938 |
|
|
391,476 |
Total
liabilities |
|
50,439 |
|
|
46,379 |
Total
stockholders’ equity |
|
244,499 |
|
|
345,097 |
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