Kronos Bio Reports Recent Business Progress and Second-Quarter 2022 Financial Results
August 04 2022 - 4:05PM
Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to
transforming the lives of those affected by cancer and other
serious diseases, today reported recent business progress and
second-quarter 2022 financial results.
“We are continuing to execute across our
clinical programs, with the registrational Phase 3 AGILITY study of
our lead SYK inhibitor, entospletinib, under way in newly diagnosed
patients with NPM1-mutated acute myeloid leukemia (AML),” said
Norbert Bischofberger, Ph.D., president and chief executive officer
of Kronos Bio. “We are also making progress with our CDK9
inhibitor, KB-0742, as we work toward identifying a recommended
Phase 2 dose in the fourth quarter.”
Second Quarter and Recent Company Updates
-
SYK Inhibitor Programs
- The company continued to enroll
patients in the Phase 3 AGILITY clinical trial of entospletinib, a
selective inhibitor targeting spleen tyrosine kinase (SYK), in
combination with standard of care anthracycline and cytarabine
(7+3) chemotherapy in newly diagnosed NPM1-mutated AML. Data are
anticipated in the second half of 2023 with a primary endpoint of
measurable residual disease negative complete response.
- Kronos Bio opened additional sites
for its planned Phase 1b/2 clinical trial of lanraplenib, the
company’s next generation SYK inhibitor, in combination with
gilteritinib in patients with FLT3-mutated AML.
- The company shared preclinical data
that provide additional support for the biological rationale for
the targeting of SYK in patients with genetically defined subsets
of AML at the European Hematology Association congress in Vienna in
two poster presentations. The first poster described the analysis
of mutational and gene expression signatures from bone marrow and
peripheral blood samples of patients with NPM1-mutated AML,
suggesting that the NPM1 mutation, with or without co-mutation of
FLT3, is a strong predictor of entospletinib anti-leukemic
activity. That research was conducted as part of a collaboration
with scientists at the Oregon Health & Science University.
- A second poster described the
company’s findings of synergistic activity of lanraplenib in
combination with other targeted agents, including gilteritinib, in
an NPM1-mutated/FLT3-mutated PDX model.
-
KB-0742
- Kronos Bio is continuing to enroll
patients in the dose escalation stage of the Phase 1/2 study of
KB-0742 in solid tumors. The company anticipates announcing the
recommended Phase 2 dose in the fourth quarter of 2022.
- Corporate Update
- Kronos Bio believes the company has
sufficient runway to fund operations into Q4 2024. This is as a
result of ongoing financial prudence measures that have included
prioritizing clinical programs to focus on entospletinib and
KB-0742.
Second Quarter
2022 Financial Highlights
- Cash, Cash Equivalents and
Investments: With its ongoing and currently planned
clinical programs and $292.4 million in cash, cash equivalents and
investments as of June 30, 2022, the company anticipates
sufficient resources to fund its planned operations into the second
half of 2024.
- R&D
Expenses: Research and development expenses were
$22.7 million for the second quarter of 2022, which includes
non-cash stock-based compensation expense of $4.1 million.
- G&A
Expenses: General and administrative expenses were
$10.8 million for the second quarter of 2022, which includes
non-cash stock-based compensation expense of $4.2 million.
- Net Loss: Net
loss for the second quarter of 2022 was $32.9 million, or $0.59 per
share, including non-cash stock-based compensation expense of $8.2
million.
About Kronos Bio, Inc.
Kronos Bio is an integrated discovery through
late-stage clinical development biopharmaceutical company, focused
on developing therapies that target the dysregulated transcription
that causes cancer and other serious diseases. Kronos Bio’s lead
investigational compound is entospletinib, an orally administered,
selective inhibitor targeting spleen tyrosine kinase (SYK) in
clinical development for the frontline treatment of NPM1-mutated
acute myeloid leukemia (AML) in combination with intensive
chemotherapy. The company is also developing KB-0742, an orally
administered inhibitor of cyclin dependent kinase 9 (CDK9), in
Phase 1/2 clinical development for the treatment of MYC-amplified
or overexpressing solid tumors.
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,” “believe,” “plan,” “expect,” 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: projections from preclinical data,
poster presentations and company findings; the anticipated
announcement of clinical data and the timing thereof; the
anticipated timing for identifying and announcing a recommended
Phase 2 dose for KB-0742; the anticipated sufficiency of the
company’s resources to fund its planned operations into the fourth
quarter of 2024; the company’s planned Phase 1b/2 clinical trial of
lanraplenib; 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 initiate, progress
or complete the current and planned clinical trials of
entospletinib, lanraplenib and KB-0742 on the timelines expected,
if at all, including due to risks inherent in the clinical
development of novel therapeutics; risks related to Kronos Bio’s
limited 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 Quarterly Report on Form 10-Q for the quarter ended
March 31, 2022, as filed with the SEC on May 4, 2022, and the
Company’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2022, which is 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.
Kronos Bio,
Inc.Condensed Statements of Operations and
Comprehensive Loss(in thousands, except share and per
share amounts)(Unaudited)
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
22,706 |
|
|
$ |
19,802 |
|
|
$ |
47,142 |
|
|
$ |
37,396 |
|
General and administrative |
|
|
10,824 |
|
|
|
9,339 |
|
|
|
22,752 |
|
|
|
17,923 |
|
Total operating expenses |
|
|
33,530 |
|
|
|
29,141 |
|
|
|
69,894 |
|
|
|
55,319 |
|
Loss from operations |
|
|
(33,530 |
) |
|
|
(29,141 |
) |
|
|
(69,894 |
) |
|
|
(55,319 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
Interest and other income,
net |
|
|
627 |
|
|
|
86 |
|
|
|
728 |
|
|
|
178 |
|
Total other income (expense),
net |
|
|
627 |
|
|
|
86 |
|
|
|
728 |
|
|
|
178 |
|
Net loss |
|
|
(32,903 |
) |
|
|
(29,055 |
) |
|
|
(69,166 |
) |
|
|
(55,141 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Net unrealized gain (loss) on available-for-sale securities |
|
|
(491 |
) |
|
|
29 |
|
|
|
(622 |
) |
|
|
25 |
|
Net comprehensive loss |
|
$ |
(33,394 |
) |
|
$ |
(29,026 |
) |
|
$ |
(69,788 |
) |
|
$ |
(55,116 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.59 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.24 |
) |
|
$ |
(1.01 |
) |
Weighted-average shares of
common stock, basic and diluted |
|
|
56,116,070 |
|
|
|
54,506,195 |
|
|
|
55,978,482 |
|
|
|
54,330,402 |
|
Kronos Bio, Inc.Selected
Balance Sheet Data(in thousands, except share and per
share amounts)(Unaudited)
|
|
June 30, 2022 |
|
December 31, 2021 |
Cash, cash equivalents and investments |
|
$ |
292,382 |
|
$ |
339,509 |
Total assets |
|
|
341,220 |
|
|
391,476 |
Total liabilities |
|
|
48,977 |
|
|
46,379 |
Total stockholders’
equity |
|
|
292,243 |
|
|
345,097 |
Contact:Marni KottleKronos
Bio415-218-7111mkottle@kronosbio.com
Investors:Claudia StyslingerArgot
Partners212-600-1902kronosbio@argotpartners.com
Media:Sheryl SeapyReal
Chemistry949-903-4750sseapy@realchemistry.com
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