Kronos Bio Reports Recent Business Progress and First-Quarter 2023 Financial Results
10 Mayo 2023 - 3:05PM
Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to
transforming the lives of those affected by cancer, today reported
recent business progress and first-quarter 2023 financial results.
"This quarter, we made significant strides in our KB-0742 and
lanraplenib clinical studies, and on the discovery side, our
collaboration with Genentech is now well underway," said Norbert
Bischofberger, Ph.D., president and chief executive officer of
Kronos Bio. "We remain unwavering in our commitment to deliver
meaningful therapies for patients with difficult to treat cancers,
and we have the innovative science and people, as well as cash
runway, necessary to do so. We continue to recruit significant
talent, most recently with the addition of Katherine and Roger to
our Board of Directors. We will benefit from their industry
experience and clinical development expertise and guidance as we
progress our portfolio of product candidates that target
deregulated transcription.”
First Quarter and Recent Company
Updates
- KB-0742
- Dosed first patient in expansion portion of Phase 1/2 study of
KB-0742 in solid tumors. Enrollment is ongoing in both Cohort A,
for patients with MYC-dependent 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.
- Dose escalation portion of the study remains ongoing to
determine maximum tolerated oral dose.
- Additional data from the Phase 1/2 study, including initial
anti-tumor activity, are expected in the second half of 2023.
- Lanraplenib
- Initial data, including recommended Phase 2 dose (RP2D), from
the combination study of lanraplenib with gilteritinib in patients
with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML)
are expected in the fourth quarter of 2023 or first quarter of
2024.
- Corporate Updates
- In April 2023, Kronos Bio announced the appointment of
Katherine Vega Stultz and Roger Dansey, M.D., to its Board of
Directors.
- Ms. Stultz brings more than 25 years of biopharmaceutical
experience and currently serves as the President and Chief
Executive Officer of Ocelot Bio. Previously, Ms. Stultz was the
Chief Operating Officer at Graphite Bio, where she successfully
advanced the company’s clinical development program and helped take
the company public. She has also held leadership roles at Celgene,
Eli Lilly & Company and ConvaTec, a Bristol-Myers Squibb
company.
- Dr. Dansey brings more than 20 years of biopharmaceutical
experience and currently serves as President, Research and
Development of Seagen Inc. At Seagen, Dr. Dansey has leveraged his
extensive drug development experience to progress the company from
a single product U.S.-based company to a four-product company with
a U.S. and European presence. Previously, Dr. Dansey was Senior
Vice President at Merck & Co., Inc., where he led the company’s
late-stage oncology development efforts. Earlier in his career, he
led oncology clinical research at Gilead Sciences and had multiple
oncology and hematology roles at Amgen.
First Quarter
2023 Financial Highlights
- Cash, Cash Equivalents and
Investments: With its ongoing and currently planned
clinical programs and $241.3 million in cash, cash equivalents and
investments as of March 31, 2023, the company reiterates its
expected cash runway into the second half of 2025.
- R&D
Expenses: Research and development expenses were
$19.7 million for the first quarter of 2023, which includes
non-cash stock-based compensation expense of $3.1 million.
- G&A
Expenses: General and administrative expenses were
$10.1 million for the first quarter of 2023, which includes
non-cash stock-based compensation expense of $3.5 million.
- Net Loss: Net
loss for the first quarter of 2023 was $26.2 million, or $0.46 per
share, including non-cash stock-based compensation expense of $6.6
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 deregulated 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 “on track to,” “plan,” “potential,” “will,” 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, Kronos Bio’s plan to report initial
efficacy data for the Phase 1/2 KB-0742 study and the expected
timing thereof, Kronos Bio’s plan to report a recommended Phase 2
dose and initial data for the Phase 1b/2 study of lanraplenib and
the timing thereof, 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 timelines
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; 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 Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the SEC on March 15, 2023, and in its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023,
being filed with the SEC 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.
Company Contact:Sarah Connors, Vice President
of Investor Relations and Corporate CommunicationsKronos
Bio857-290-7305sconnors@kronosbio.com
Investors:Claudia
StyslingerArgot
Partners212-600-1902kronosbio@argotpartners.com
Media:Leo Vartorella/David Rosen Argot
Partners 212-600-1494
kronosbio@argotpartners.com
Kronos Bio, Inc. |
Condensed Statements of Operations and Comprehensive
Loss |
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
Three months ended March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
|
$ |
1,221 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
19,658 |
|
|
$ |
24,438 |
|
General and administrative |
|
|
10,056 |
|
|
|
11,927 |
|
Total operating expenses |
|
|
29,714 |
|
|
|
36,365 |
|
Loss from operations |
|
|
(28,493 |
) |
|
|
(36,365 |
) |
Other income (expense),
net: |
|
|
|
|
Interest and other income,
net |
|
|
2,255 |
|
|
|
102 |
|
Total other income (expense),
net |
|
|
2,255 |
|
|
|
102 |
|
Net loss |
|
|
(26,238 |
) |
|
|
(36,263 |
) |
Other comprehensive income (loss): |
|
|
|
|
Net unrealized gain (loss) on available-for-sale securities |
|
|
432 |
|
|
|
(131 |
) |
Net comprehensive loss |
|
$ |
(25,806 |
) |
|
$ |
(36,394 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.65 |
) |
Weighted-average shares of
common stock, basic and diluted |
|
|
57,147,253 |
|
|
|
55,839,336 |
|
Kronos Bio, Inc. |
Selected Balance Sheet Data |
(in thousands, except share and per share amounts) |
(Unaudited) |
|
|
|
March 31, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and investments |
|
$ |
241,287 |
|
$ |
247,947 |
Total assets |
|
|
289,025 |
|
|
294,938 |
Total liabilities |
|
|
63,420 |
|
|
50,439 |
Total stockholders’
equity |
|
|
225,605 |
|
|
244,499 |
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