Kronos Bio Reports Recent Business Progress and Third-Quarter 2023 Financial Results
November 13 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 third-quarter 2023 financial results.
“This quarter, we made great strides in advancing our clinical
programs as well as our discovery projects and Genentech
collaboration,” said Norbert Bischofberger, Ph.D., president and
chief executive officer of Kronos Bio. “At the AACR-NCI-EORTC and
CTOS conferences we shared KB-0742 data that demonstrated
on-mechanism, single agent anti-tumor activity in pre-treated
patients with transcriptionally addicted solid tumors. We are
encouraged by the strong investigator interest in KB-0742, and the
potential impact of this positive preliminary efficacy data and
manageable safety profile for patients.”
Dr. Bischofberger continued, “With our resource optimization and
extended cash runway, I’m confident that we are well-positioned to
deliver on our mission to bring forward new and innovative
therapies for difficult-to-treat cancers. Our team is committed to
realizing the potential of drugging transcription in cancer.”
Third Quarter and Recent Company
Updates
- KB-0742
- Kronos Bio presented positive preliminary data from the Phase 1
dose escalation portion of the ongoing Phase 1/2 KB-0742 study at
the AACR-NCI-EORTC International Conference in October and at the
Connective Tissue Oncology Society Annual Meeting in November,
where it also presented corresponding data from the pre-clinical
mechanistic studies.
- KB-0742 demonstrated on-mechanism, single agent anti-tumor
activity and a manageable safety profile in pre-treated patients
with transcriptionally addicted solid tumors.
- Enrollment in two expansion cohorts is ongoing, including
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 transcription factor
fusion-driven cancers and other transcriptionally addicted cancers
including chordomas, sarcomas and small cell lung cancer.
- The Company plans to share data from both the ongoing dose
escalation, beyond the 60 mg dose, and from the expansion portions
of the Phase 1/2 KB-0742 study in mid-2024.
- Lanraplenib
- Lanraplenib is currently in the dose escalation portion of a
Phase 1b/2 trial in combination with gilteritinib in patients with
relapsed/refractory FLT3-mutated acute myeloid leukemia.
- Three patients have cleared the 28-day safety window at each of
the 20 mg, 40 mg and 60 mg dose levels.
- The Company is now enrolling at the 90 mg dose. To better
understand safety, PK and PD, and to accommodate investigator and
patient interest, additional patients may be enrolled at dose
levels below 90 mg.
- Kronos Bio anticipates announcing the recommended expansion
phase dose in Q4 2023/Q1 2024 and plans to share data from the
Phase 1b/2 study in mid-2024.
- Corporate Update
- On November 2, 2023, Kronos Bio announced its plan to optimize
its resource allocation, restructure and contain costs in light of
the positive preliminary safety and efficacy clinical data from its
Phase 1/2 study of KB-0742.
- This plan positions the Company to maximize the potential of
KB-0742 while continuing to advance the development of lanraplenib,
currently in the dose escalation portion of a Phase 1b/2
study.
- The Company will also focus its discovery efforts on maturing
projects and its Genentech collaboration activities.
- Kronos Bio expects that these efforts, which include a 19%
reduction in force, will extend its cash runway into 2026.
Third Quarter
2023 Financial Highlights
- Cash, Cash Equivalents and
Investments: With its ongoing and currently planned
clinical programs and $198.4 million in cash, cash equivalents and
investments as of September 30, 2023, the Company reiterates
its expected cash runway into 2026.
- R&D
Expenses: Research and development expenses were
$25.3 million for the third quarter of 2023, which includes
non-cash stock-based compensation expense of $3.2 million.
- G&A
Expenses: General and administrative expenses were
$9.4 million for the third quarter of 2023, which includes non-cash
stock-based compensation expense of $3.1 million.
- Net Loss: Net
loss for the third quarter of 2023 was $31.4 million, or $0.54 per
share, including non-cash stock-based compensation expense of $6.3
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
“anticipate,” “expect,” “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 recently announced
resource optimization and restructuring plan and the expected
benefits therefrom; potential enrollment of additional patients in
the lanraplenib trial, including at doses below 90 mg; Kronos Bio’s
plan to provide a recommended expansion phase dose for lanraplenib
and report data and the timing thereof; the potential of Kronos
Bio’s product candidates, including any potential implied from
early clinical data; 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: unintended
consequences from the reduction in workforce; changes in the
macroeconomic environment or competitive landscape that impact
Kronos Bio’s business; 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 limited experience as a company in
conducting clinical trials; the risk that results of preclinical
studies and early clinical trials (including preliminary results)
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
June 30, 2023, filed with the SEC on August 8, 2023, and in its
Quarterly Report on Form 10-Q for the quarter ended September 30,
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.
Media Contact:Sarah Connors, Vice President of
Corporate Affairs, Kronos
Bio857-290-7305sconnors@kronosbio.com
Investor Contact:Margaux BennettExecutive
Director, Business Development and Investor Relations, Kronos
Bio650-781-5026mbennett@kronosbio.com
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, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
|
$ |
917 |
|
|
$ |
— |
|
|
$ |
4,002 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
25,344 |
|
|
$ |
23,403 |
|
|
$ |
67,675 |
|
|
$ |
70,547 |
|
General and administrative |
|
|
9,398 |
|
|
|
10,135 |
|
|
|
30,813 |
|
|
|
32,886 |
|
Total operating expenses |
|
|
34,742 |
|
|
|
33,538 |
|
|
|
98,488 |
|
|
|
103,433 |
|
Loss from operations |
|
|
(33,825 |
) |
|
|
(33,538 |
) |
|
|
(94,486 |
) |
|
|
(103,433 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
Interest and other income,
net |
|
|
2,451 |
|
|
|
1,282 |
|
|
|
7,133 |
|
|
|
2,011 |
|
Total other income, net |
|
|
2,451 |
|
|
|
1,282 |
|
|
|
7,133 |
|
|
|
2,011 |
|
Net loss |
|
|
(31,374 |
) |
|
|
(32,256 |
) |
|
|
(87,353 |
) |
|
|
(101,422 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Net unrealized gain (loss) on available-for-sale securities |
|
|
214 |
|
|
|
(389 |
) |
|
|
537 |
|
|
|
(1,011 |
) |
Net comprehensive loss |
|
$ |
(31,160 |
) |
|
$ |
(32,645 |
) |
|
$ |
(86,816 |
) |
|
$ |
(102,433 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.52 |
) |
|
$ |
(1.81 |
) |
Weighted-average shares of
common stock, basic and diluted |
|
|
58,146,306 |
|
|
|
56,318,571 |
|
|
|
57,567,489 |
|
|
|
56,093,091 |
|
|
|
|
|
|
|
|
|
|
Kronos Bio, Inc.Selected Balance Sheet Data(in
thousands)(Unaudited) |
|
|
|
September 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and investments |
|
$ |
198,383 |
|
$ |
247,947 |
Total assets |
|
|
237,993 |
|
|
294,938 |
Total liabilities |
|
|
59,373 |
|
|
50,439 |
Total stockholders’
equity |
|
|
178,620 |
|
|
244,499 |
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