Kronos Bio Reports Recent Business Progress and Second-Quarter 2023 Financial Results
08 August 2023 - 10:05PM
Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to
transforming the lives of those affected by cancer, today reported
recent business progress and second-quarter 2023 financial results.
“KB-0742 is the first molecule to emerge from our discovery
platform and we are looking forward to presenting data from the
Phase 1 dose escalation portion of the Phase 1/2 KB-0742 study at
the upcoming AACR-NCI-EORTC International Conference,” said Norbert
Bischofberger, Ph.D., president and chief executive officer of
Kronos Bio. “We’ve observed target engagement and have opened
expansion cohorts at the 60 milligram dose. Simultaneously, we are
further dose escalating to identify the maximum tolerated dose.
Strong investigator engagement and patient enrollment in our
KB-0742 and lanraplenib clinical programs reinforce the significant
unmet need for new and innovative therapies for these
difficult-to-treat cancers.”
Bischofberger continued, “Our lanraplenib program recently
progressed onto the third dosing cohort at 60 milligrams, and we
are on track to reach our recommended Phase 2 dose by year end or
early 2024. In addition, as a result of strong investigator
interest, we will be allowing additional patients to enroll at dose
levels that have previously been cleared. We look forward to
sharing data from the escalation cohorts in
mid-2024.”
Second Quarter and Recent Company
Updates
- KB-0742
- Kronos Bio will present data from 28 patients enrolled in the
dose escalation portion of the Phase 1/2 KB-0742 study who received
up to and including the 60 mg dose at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics taking place from October 11 to 15, 2023, in Boston,
Massachusetts. At the 60 mg dose, 10 patients received one or more
cycles of KB-0742 (one cycle is 28 days).
- For the dose escalation, the study enrolled an unselected
relapsed/ refractory solid tumor population.
- The presentation will include data on safety, tolerability,
pharmacokinetics (PK), pharmacodynamics (PD), as well as anti-tumor
activity.
- 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 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 1/2 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 and 40 mg dose levels.
- The Company is now enrolling at the 60 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 60 mg.
- Kronos Bio anticipates achieving the recommended phase 2 dose
in Q4 2023/Q1 2024 and expects to share data from this study in
mid-2024.
- Corporate Update
- In June 2023, Kronos Bio announced the appointment of Marc
Besman, Ph.D., as Senior Vice President of Regulatory Affairs and
Clinical Quality Assurance. Dr. Besman will be responsible for
developing, implementing and advancing global regulatory strategies
for Kronos Bio’s portfolio. Dr. Besman has extensive drug
development experience in oncology, and joined Kronos Bio from
Coherus BioSciences, where he served as Senior Vice President of
Regulatory Affairs.
Second Quarter
2023 Financial Highlights
- Cash, Cash Equivalents and
Investments: With its ongoing and currently planned
clinical programs and $219.7 million in cash, cash equivalents and
investments as of June 30, 2023, the company reiterates its
expected cash runway into the second half of 2025.
- R&D
Expenses: Research and development expenses were
$22.7 million for the second quarter of 2023, which includes
non-cash stock-based compensation expense of $3.1 million.
- G&A
Expenses: General and administrative expenses were
$11.4 million for the second quarter of 2023, which includes
non-cash stock-based compensation expense of $3.8 million.
- Net Loss: Net
loss for the second quarter of 2023 was $29.7 million, or $0.52 per
share, including non-cash stock-based compensation expense of $6.9
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 plans to report data for the Phase 1/2 KB-0742
study and the expected timing thereof, Kronos Bio’s plan to achieve
a recommended Phase 2 dose and report 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, filed with the SEC on May 10, 2023,
and in its Quarterly Report on Form 10-Q for the quarter ended June
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.
Contacts for Investors and Media:
Company Contact:Sarah Connors, Vice President
of Investor Relations and Corporate CommunicationsKronos
Bio857-290-7305sconnors@kronosbio.com
Agency Contact:Brendan Strong, Managing
DirectorArgot Partners
212-600-1902kronosbio@argotpartners.com
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, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
|
$ |
1,864 |
|
|
$ |
— |
|
|
$ |
3,084 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
22,673 |
|
|
$ |
22,706 |
|
|
$ |
42,331 |
|
|
$ |
47,142 |
|
General and administrative |
|
|
11,359 |
|
|
|
10,824 |
|
|
|
21,415 |
|
|
|
22,752 |
|
Total operating expenses |
|
|
34,032 |
|
|
|
33,530 |
|
|
|
63,746 |
|
|
|
69,894 |
|
Loss from operations |
|
|
(32,168 |
) |
|
|
(33,530 |
) |
|
|
(60,662 |
) |
|
|
(69,894 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
Interest and other income,
net |
|
|
2,427 |
|
|
|
627 |
|
|
|
4,683 |
|
|
|
728 |
|
Total other income (expense),
net |
|
|
2,427 |
|
|
|
627 |
|
|
|
4,683 |
|
|
|
728 |
|
Net loss |
|
|
(29,741 |
) |
|
|
(32,903 |
) |
|
|
(55,979 |
) |
|
|
(69,166 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Net unrealized gain (loss) on available-for-sale securities |
|
|
(109 |
) |
|
|
(491 |
) |
|
|
323 |
|
|
|
(622 |
) |
Net comprehensive loss |
|
$ |
(29,850 |
) |
|
$ |
(33,394 |
) |
|
$ |
(55,656 |
) |
|
$ |
(69,788 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.98 |
) |
|
$ |
(1.24 |
) |
Weighted-average shares of
common stock, basic and diluted |
|
|
57,397,931 |
|
|
|
56,116,070 |
|
|
|
57,273,284 |
|
|
|
55,978,482 |
|
|
|
|
|
|
|
|
|
|
Kronos Bio, Inc.Selected
Balance Sheet Data(in thousands)(Unaudited)
|
|
June 30, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and investments |
|
$ |
219,704 |
|
$ |
247,947 |
Total assets |
|
|
260,615 |
|
|
294,938 |
Total liabilities |
|
|
57,273 |
|
|
50,439 |
Total stockholders’
equity |
|
|
203,342 |
|
|
244,499 |
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