Kronos Bio Reports Recent Business Progress and Third-Quarter 2022 Financial Results
November 08 2022 - 4:10PM
Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to
transforming the lives of those affected by cancer, today reported
recent business progress and third-quarter 2022 financial results.
In a press release issued earlier this
afternoon, the company announced the prioritization of its clinical
portfolio to focus on its next-generation SYK inhibitor,
lanraplenib, and its CDK9 inhibitor, KB-0742, and the decision to
discontinue the Phase 3 entospletinib trial. Kronos Bio believes
that focusing on lanraplenib and KB-0742 will allow the company to
direct its resources to the highest value programs and deliver on
its mission of bringing cancer drugs to the patients with the
greatest need.
Third Quarter and
Recent Company Updates
-
Entospletinib
- After a recent review of enrollment
data that projected significant delays, Kronos Bio will discontinue
the Phase 3 entospletinib trial and close enrollment in the fourth
quarter of 2022. The trial is not being discontinued due to adverse
events or lack of efficacy signals.
-
Lanraplenib
-
The company 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.
- KB-0742
-
Kronos Bio remains on track to report pharmacokinetic (PK),
pharmacodynamic (PD) and safety data, as well as the RP2D, from the
Phase 1/2 study of KB-0742 in solid tumors in the fourth quarter of
2022.
-
After reaching RP2D, the company plans to enroll two cohorts of
patients in the next stage of the trial: patients with
MYC-amplified solid tumors and patients with transcriptionally
addicted cancers.
-
Initial KB-0742 efficacy data are anticipated in the second half of
2023.
Third Quarter
2022 Financial Highlights
- Cash, Cash Equivalents and
Investments: With its ongoing and currently planned
clinical programs and $270.3 million in cash, cash equivalents and
investments as of September 30, 2022, the company anticipates
sufficient resources to fund its planned operations into the second
quarter of 2025.
- R&D
Expenses: Research and development expenses were
$23.4 million for the third quarter of 2022, which includes
non-cash stock-based compensation expense of $3.5 million.
- G&A
Expenses: General and administrative expenses were
$10.1 million for the third quarter of 2022, which includes
non-cash stock-based compensation expense of $4.0 million.
- Net Loss: Net
loss for the third quarter of 2022 was $32.3 million, or $0.57 per
share, including non-cash stock-based compensation expense of $7.5
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
lanraplenib, a next-generation SYK inhibitor, for patients with
relapsed/refractory 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
StatementsStatements 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,”
“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: 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 company’s enrollment
plans for KB-0742 after reaching recommended Phase 2 dose, Kronos
Bio’s plan to provide a further update and share initial efficacy
data for KB-0742 and the timing thereof; the company’s product
development plans; the anticipated sufficiency of the company’s
resources to fund its planned operations into the second quarter of
2025; 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 or complete its ongoing
clinical trials of 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;
Kronos Bio has encountered and may continue to encounter delays and
difficulties initiating clinical trial sites and enrolling patients
in its clinical trials, and, as a result, its clinical development
activities could be delayed or otherwise adversely affected; Kronos
Bio’s discovery and development activities are primarily focused on
novel cancer therapeutics for patients with genetically-defined
cancers and it is difficult to predict the time and cost of
developing its product candidates and obtaining regulatory
approval; the company’s projected cash runway is based on the
company’s current development plans and assumptions that may prove
to be wrong, and changing circumstances may likewise cause the
company to consume capital significantly faster than it currently
anticipates; and other 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 June 30, 2022, as filed with the
SEC on August 4, 2022, and the Company’s Quarterly Report on Form
10-Q for the quarter ended September 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 September 30, |
|
Nine months ended September 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
23,403 |
|
|
$ |
24,688 |
|
|
$ |
70,547 |
|
|
$ |
62,084 |
|
General and administrative |
|
|
10,135 |
|
|
|
8,985 |
|
|
|
32,886 |
|
|
|
26,908 |
|
Total operating expenses |
|
|
33,538 |
|
|
|
33,673 |
|
|
|
103,433 |
|
|
|
88,992 |
|
Loss from operations |
|
|
(33,538 |
) |
|
|
(33,673 |
) |
|
|
(103,433 |
) |
|
|
(88,992 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
Interest and other income,
net |
|
|
1,282 |
|
|
|
70 |
|
|
|
2,011 |
|
|
|
248 |
|
Total other income (expense),
net |
|
|
1,282 |
|
|
|
70 |
|
|
|
2,011 |
|
|
|
248 |
|
Net loss |
|
|
(32,256 |
) |
|
|
(33,603 |
) |
|
|
(101,422 |
) |
|
|
(88,744 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Net unrealized gain (loss) on available-for-sale securities |
|
|
(389 |
) |
|
|
1 |
|
|
|
(1,011 |
) |
|
|
26 |
|
Net comprehensive loss |
|
$ |
(32,645 |
) |
|
$ |
(33,602 |
) |
|
$ |
(102,433 |
) |
|
$ |
(88,718 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.57 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.81 |
) |
|
$ |
(1.63 |
) |
Weighted-average shares of
common stock, basic and diluted |
|
|
56,318,571 |
|
|
|
54,977,085 |
|
|
|
56,093,091 |
|
|
|
54,549,747 |
|
Kronos Bio, Inc.Selected
Balance Sheet Data(in thousands, except share and per
share amounts)(Unaudited)
|
|
September 30, 2022 |
|
December 31, 2021 |
Cash, cash equivalents and
investments |
|
$ |
270,341 |
|
$ |
339,509 |
Total assets |
|
|
317,668 |
|
|
391,476 |
Total liabilities |
|
|
49,981 |
|
|
46,379 |
Total stockholders’
equity |
|
|
267,687 |
|
|
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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