Calithera Biosciences Reports First Quarter 2019 Financial Results and Recent Highlights
May 09 2019 - 4:06PM
Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage
biopharmaceutical company pioneering the discovery and development
of targeted therapies that disrupt cellular metabolic pathways,
announced today its financial results for the first quarter ended
March 31, 2019. As of March 31, 2019, cash equivalents and
investments totaled $117.0 million.
“This year we expect to achieve multiple, key milestones in our
clinical development program and several data readouts, including
top-line results of the ENTRATA trial mid-year, and with our
partner Incyte, data from the INCB001158 program in the second half
of the year,” said Susan Molineaux, PhD, president and chief
executive officer of Calithera. “In the first quarter, we’ve also
made great strides in our earlier stage programs, moving our cystic
fibrosis program into the clinic and presenting preclinical data on
our CD73 inhibitor, which is poised to enter the clinic by year
end.”
First Quarter 2019 and Recent Highlights
- Completed enrollment of the Phase 2 renal cell
carcinoma ENTRATA trial. The ENTRATA trial (NCT03163667)
is a Phase 2 randomized, double blind trial designed to evaluate
the safety and efficacy of telaglenastat in combination with
everolimus versus placebo with everolimus in patients with advanced
clear cell RCC who have been treated with at least two prior lines
of systemic therapy, including at least one prior VEGFR-targeted
tyrosine kinase inhibitor. The trial enrolled 69 patients at
multiple centers in the United States. The primary endpoint of
ENTRATA is progression-free survival (PFS). Calithera plans to
report top-line results including key efficacy and safety data in
mid-2019.
- Initiated Phase 1/2 clinical trial of telaglenastat
(CB-839) in combination with talazoparib for solid tumors.
The Phase 1/2 clinical trial is evaluating telaglenastat in
combination with Pfizer’s PARP inhibitor talazoparib in patients
with solid tumors. Calithera expects to initiate an additional
trial of the combination of telaglenastat plus the CDK4/6 inhibitor
palbociclib in patients with KRAS-mutated colorectal cancer and
KRAS-mutated non-small cell lung cancer in the second quarter of
2019.
- Initiated Phase 1 trial of arginase inhibitor CB-280
for the treatment of cystic fibrosis. Arginase is believed
to be critical in the pathology of cystic fibrosis. It impairs
production of nitric oxide and generates metabolites of arginine
that may impair lung function. CB-280 is an orally administered
small molecule inhibitor of arginase. The first-in-human Phase 1
trial initiated in February 2019 will evaluate the safety,
tolerability and pharmacokinetic profile of oral CB-280 in healthy
volunteers.
- Presented preclinical data for CB-708 at AACR Annual
Meeting 2019. The preclinical data presented at the 2019
American Association for Cancer Research (AACR) Annual Meeting
demonstrate that CB-708 is a potent and selective inhibitor of CD73
that has immune-mediated, single-agent activity in syngeneic mouse
tumor models. In the pre-clinical studies presented, CB-708 was
well-tolerated and shows enhanced anti-tumor activity in
combination with checkpoint inhibitors as well as chemotherapy.
Calithera anticipates that CB-708 will enter clinical trials in
2019.
Selected First Quarter 2019 Financial
Results
Cash, cash equivalents and investments totaled
$117.0 million at March 31, 2019.
Research and development expenses were $20.2
million for the three months ended March 31, 2019, compared with
$15.5 million for the same period in the prior year. The increase
of $4.7 million was primarily due to a $2.3 million increase in the
telaglenastat program, including our Phase 2 CANTATA trial, an
increase of $1.1 million in the INCB001158 program, an increase of
$1.0 million in the CB-280 program, as well as investment in early
stage research.
General and administrative expenses were $4.2
million for the three months ended March 31, 2019, compared with
$3.5 million for the same period in the prior year. The increase of
$0.7 million was related to higher personnel-related costs and
professional services costs.
Net loss for the three months ended March 31, 2019 was $23.7
million, or $0.61 per share.
Conference Call Information
Calithera will host an update conference call today, Thursday,
May 9 at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call
may be accessed by dialing (855) 783-2599 (domestic) or (631)
485-4877 and referring to conference ID 1182244. To access the live
audio webcast or the subsequent archived recording, visit the
Investors section of the Calithera website at www.calithera.com.
The webcast will be recorded and available for replay on
Calithera’s website for 30 days.
About Calithera
Calithera Biosciences is a clinical-stage biopharmaceutical
company pioneering the discovery and development of targeted
therapies that disrupt cellular metabolic pathways to
preferentially starve tumor cells and enhance immune-cell activity.
Driven by a commitment to rigorous science and a passion for
improving the lives of people impacted by cancer and other
life-threatening diseases, Calithera is advancing a pipeline of
first-in-clinic, oral therapeutics to meaningfully expand treatment
options available to patients. Calithera is headquartered in South
San Francisco, California. For more information about Calithera,
please visit www.calithera.com.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Words such as "may," "will," "expect," "anticipate,"
"estimate," "intend," "poised" and similar expressions (as well as
other words or expressions referencing future events, conditions,
or circumstances) are intended to identify forward-looking
statements. These statements include those related to Calithera’s
clinical trials, the clinical and commercial potential of its
product candidates, Calithera’s plans to report data from its Phase
2 ENTRATA trial in 2019; the trial design and enrollment of
patients in the ENTRATA and CANTATA trials; Calithera’s plan to
initiate additional clinical trials of CB-839 in collaboration with
Pfizer; and the timing that CB-708 will enter clinical trials in
2019. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. The
potential product candidates that Calithera develops may not
progress through clinical development or receive required
regulatory approvals within expected timelines or at all. In
addition, clinical trials may not confirm any safety, potency or
other product characteristics described or assumed in this press
release. Such product candidates may not be beneficial to patients
or successfully commercialized. The failure to meet expectations
with respect to any of the foregoing matters may have a negative
effect on Calithera's stock price. Additional information
concerning these and other risk factors affecting Calithera's
business can be found in Calithera's periodic filings with the
Securities and Exchange Commission at www.sec.gov. These
forward-looking statements are not guarantees of future performance
and speak only as of the date hereof, and, except as required by
law, Calithera disclaims any obligation to update these
forward-looking statements to reflect future events or
circumstances.
SOURCE: Calithera Biosciences, Inc.
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Calithera Biosciences, Inc. |
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Selected Consolidated Statements of Operations Financial
Data |
|
|
(in thousands, except per share amounts) |
|
|
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(unaudited) |
|
|
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Three Months Ended March
31, |
|
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2019 |
|
|
|
2018 |
|
Revenue: |
|
|
|
Collaboration revenue |
$ |
— |
|
|
$ |
5,189 |
|
Total revenue |
|
— |
|
|
|
5,189 |
|
Operating expenses: |
|
|
|
Research and development |
|
20,239 |
|
|
|
15,493 |
|
General and administrative |
|
4,164 |
|
|
|
3,508 |
|
Total operating expenses |
|
24,403 |
|
|
|
19,001 |
|
Loss from operations |
|
(24,403 |
) |
|
|
(13,812 |
) |
Interest income, net |
|
716 |
|
|
|
606 |
|
Net loss |
$ |
(23,687 |
) |
|
$ |
(13,206 |
) |
Net loss per share, basic and
diluted |
$ |
(0.61 |
) |
|
$ |
(0.37 |
) |
Weighted average common shares used to compute net loss per share,
basic and diluted |
|
38,866 |
|
|
|
35,779 |
|
|
|
|
|
|
|
|
|
Calithera Biosciences, Inc. |
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|
Selected Consolidated Balance Sheet Financial
Data |
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(in thousands) |
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|
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(unaudited) |
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|
|
|
|
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March 31, |
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December 31, |
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2019 |
|
|
|
2018 |
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Balance Sheet
Data: |
|
|
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Cash, cash equivalents and investments |
$ |
116,999 |
|
|
$ |
136,153 |
|
Working capital |
|
103,254 |
|
|
|
125,371 |
|
Total assets |
|
131,906 |
|
|
|
142,725 |
|
Total liabilities |
|
25,932 |
|
|
|
16,011 |
|
Accumulated deficit |
|
(219,928 |
) |
|
|
(196,170 |
) |
Total stockholders’ equity |
|
105,974 |
|
|
|
126,714 |
|
|
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CONTACT:Jennifer McNealey
ir@Calithera.com
650-870-1071
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