Calithera Biosciences Reports Fourth Quarter 2019 Financial Results and Recent Highlights
12 March 2020 - 7:10AM
Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage
biotechnology company focused on discovering and developing novel
small molecule drugs for the treatment of cancer and other
life-threatening diseases, announced today its financial results
for the fourth quarter ended December 31, 2019. As of December 31,
2019, cash, cash equivalents and investments totaled $157.4
million.
“As a whole, 2019 was a productive and positive year in which we
made significant progress on our clinical programs. In addition to
reading out positive topline data from the ENTRATA trial, we
completed enrollment in our registrational CANTATA trial, and we
presented the first data from the ongoing trial of the arginase
inhibitor INCB001158 in combination with pembrolizumab,” said Susan
Molineaux, PhD, president and chief executive officer of Calithera.
“In the fourth quarter, we maintained a strong cash position and
continued to advance our key clinical development programs,
including working diligently toward the initiation of our first
clinical trial evaluating telaglenastat in non-small cell lung
cancer patients with NRF2/KEAP1 genetic mutations.”
Fourth Quarter 2019 and Recent Highlights
- Completed patient enrollment of randomized CANTATA
trial of telaglenastat with cabozantinib in advanced renal cell
carcinoma (RCC). The CANTATA trial is a global,
randomized, double-blind clinical trial of telaglenastat combined
with cabozantinib, in patients with advanced or metastatic RCC who
have received one or two prior treatments. The CANTATA trial
enrolled 444 patients at multiple centers globally. The primary
endpoint is progression-free survival (PFS). Calithera plans to
report top-line efficacy and safety data from the trial in late
third quarter or fourth quarter 2020.
- Advancement toward initiation of a randomized trial in
non-small cell lung cancer (NSCLC) patients with genetic mutation
NRF2/KEAP1. The NRF2/KEAP1 pathway is known to drive the
development of certain cancers, including a significant proportion
of NSCLC, through the management of oxidative stress in a manner
that makes the cancer cell highly dependent upon glutaminase
activity. Recently presented clinical data demonstrate that
activation of this pathway, either through the loss of KEAP1
function or activation of NRF2, results in very poor outcomes in
NSCLC patients. In addition, preclinical data demonstrated that
activation of the KEAP1/NRF2 pathway make NSCLC cancer more
aggressive but also much more sensitive to telaglenastat. The clear
mechanistic rationale, strong preclinical data, and high unmet
medical need in the NSCLC population have led Calithera to design a
clinical study that will evaluate telaglenastat in combination with
standard of care chemo-immunotherapy in first line NSCLC patients
with tumors that harbor mutations in either KEAP1 or NRF2. This
trial is expected to begin enrollment in the first half of 2020. We
plan to present interim data from this trial in 2021.
- Presented results of Phase 2 ENTRATA study of
telaglenastat (CB-839) with everolimus in RCC at the ESMO 2019
Congress. The ENTRATA trial (NCT03163667) was 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 the trial was
PFS per investigator assessment with a predetermined threshold of
p≤0.2 one-sided. Telaglenastat, when added to everolimus, doubled
the median PFS in heavily pretreated patients with advanced RCC to
3.8 months as compared to 1.9 months for everolimus alone, and
reduced the risk of disease progression or death by 36% (HR=0.64,
p=0.079 one-sided). The secondary endpoint of overall survival is
not yet mature.
- Presented new INCB001158 data at the ESMO 2019
Congress. Calithera and Incyte are collaborating to
conduct this Phase 1 study evaluating INCB001158 as monotherapy and
in combination with the PD-1 inhibitor pembrolizumab in checkpoint
inhibitor refractory and naïve advanced/metastatic solid tumors.
Responses were observed in patients with microsatellite stable
(MSS) colorectal cancer, a disease not historically sensitive to
checkpoint inhibition.
- Completed a Phase 1 clinical trial of CB-280 in healthy
volunteers. The first-in-human Phase 1 trial evaluated the
safety, tolerability and pharmacokinetic profile of oral CB-280 in
healthy volunteers. A Phase 1b clinical study in people with cystic
fibrosis (CF), which is expected to start enrollment in the first
half of 2020, will test multiple doses of CB-280 compared to
placebo in approximately 30 adults with CF to determine a safe dose
range, and evaluate pharmacodynamic effects of arginase inhibition
in this population.
Selected Fourth Quarter and Full Year 2019 Financial
Results
Cash, cash equivalents and investments totaled
$157.4 million at December 31, 2019.
Research and development expenses for the full
year 2019 were $76.3 million, compared to $66.2 million
in the prior year. The increase of $10.1 million was due to a
$6.7 million increase in the telaglenastat program, including for
our CANTATA trial where we completed enrollment in 2019 and expect
top-line results in late third quarter or fourth quarter 2020, an
increase of $3.1 million in the INCB001158 program, an increase of
$0.2 million in the CB-280 program, and an increase of $0.1 million
for investment in our early-stage research programs. Research and
development expenses for the fourth quarter of 2019 were
$17.9 million, compared to $17.0 million for the same
period last year.
General and administrative expenses for the
full year 2019 were $16.6 million, compared to
$13.3 million in the prior year. The increase of
$3.3 million in 2019 was primarily related to $2.1 million
higher professional services costs mainly for legal and accounting
services and $1.0 million higher personnel-related costs, primarily
from higher headcount. General and administrative expenses for the
fourth quarter of 2019 were $4.6 million, compared to
$3.2 million for the same period last year.
Interest and other income, net for the
full year 2019 was $3.0 million, compared to $2.6 million
in the prior year. Interest and other income, net for the fourth
quarter of 2019 and 2018 were $0.7 million.
Net loss for the three months and year ended December 31, 2019
was $21.7 million and $89.9 million, respectively.
Conference Call Information
Calithera will host an update conference call today, Thursday,
March 11, 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 8862716. 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 block 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; the receipt of top-line efficacy and safety
data in the CANTATA trial; the timing of enrollment of the
randomized trial in NSCLC patients with genetic mutation NRF2/KEAP1
and the presentation of interim data from this trial; the safety
and anti-tumor activity of telaglenastat plus palbociclib; and the
timing that CB-280 will enter clinical trials. 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.
Calithera Biosciences, Inc.Selected
Consolidated Statements of Operations Financial
Data(in thousands, except per share
amounts)(unaudited)
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
22,254 |
|
Total revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
22,254 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
17,902 |
|
|
|
16,977 |
|
|
|
76,290 |
|
|
|
66,195 |
|
General and administrative |
|
4,551 |
|
|
|
3,247 |
|
|
|
16,605 |
|
|
|
13,340 |
|
Total operating expenses |
|
22,453 |
|
|
|
20,224 |
|
|
|
92,895 |
|
|
|
79,535 |
|
Loss from
operations |
|
(22,453 |
) |
|
|
(20,224 |
) |
|
|
(92,895 |
) |
|
|
(57,281 |
) |
Interest and
other income, net |
|
725 |
|
|
|
725 |
|
|
|
3,035 |
|
|
|
2,652 |
|
Net
loss |
$ |
(21,728 |
) |
|
$ |
(19,499 |
) |
|
$ |
(89,860 |
) |
|
$ |
(54,629 |
) |
Net loss per
share, basic and diluted |
$ |
(0.39 |
) |
|
$ |
(0.51 |
) |
|
$ |
(1.90 |
) |
|
$ |
(1.49 |
) |
Weighted-average common shares used to compute net loss per share,
basic and diluted |
|
55,055 |
|
|
|
38,333 |
|
|
|
47,312 |
|
|
|
36,604 |
|
|
|
|
|
|
|
|
|
Calithera Biosciences, Inc. Selected
Consolidated Balance Sheet Financial Data(in
thousands)(unaudited)
|
December
31, |
|
December
31, |
|
|
2019 |
|
|
|
2018 |
|
Balance Sheet Data: |
|
|
|
Cash, cash equivalents and investments |
$ |
157,361 |
|
|
$ |
136,153 |
|
Working capital |
|
140,172 |
|
|
|
125,371 |
|
Total assets |
|
168,768 |
|
|
|
142,725 |
|
Total liabilities |
|
26,342 |
|
|
|
16,011 |
|
Accumulated deficit |
|
(286,101 |
) |
|
|
(196,170 |
) |
Total stockholders’ equity |
|
142,426 |
|
|
|
126,714 |
|
|
|
|
|
CONTACT:Jennifer
McNealeyir@Calithera.com650-870-1071
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