Calithera Biosciences Reports Second Quarter 2019 Financial Results and Recent Highlights
August 08 2019 - 4:05PM
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 second quarter ended June 30, 2019. As of June 30, 2019,
cash equivalents and investments totaled $153.2 million.
“In the second quarter, we achieved clinical
proof of concept for our glutaminase inhibitor telaglenastat, with
positive topline results of the randomized phase 2 ENTRATA study,”
said Susan Molineaux, PhD, president and chief executive officer of
Calithera. “After completing a secondary offering in the quarter,
we are well positioned to execute on our strategy and advance our
pipeline forward. In the second half of the year, we look forward
to completing enrollment in our registrational CANTATA trial
evaluating telaglenastat for the treatment of patients with renal
cell carcinoma, as well as presenting data from our arginase
inhibitor program INCB001158.”
Second Quarter 2019 and Recent
Highlights
- Achieved positive topline
results in randomized Phase 2 ENTRATA study of telaglenastat
(CB-839) with everolimus in renal cell carcinoma. 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 ENTRATA was progression-free survival (PFS). The
combination doubled the median PFS in heavily pretreated patients
with advanced RCC. Telaglenastat, when added to everolimus, doubled
the median PFS 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 primary endpoint of
the trial was PFS per investigator assessment with a predetermined
threshold of p≤0.2 one-sided. The secondary endpoint of overall
survival is not yet mature.
- Initiated Phase 1/2
clinical trial of telaglenastat in combination with palbociclib for
solid tumors. The Phase 1/2 clinical trial is evaluating
telaglenastat in combination with Pfizer’s CDK4/6 inhibitor
palbociclib, also known as Ibrance®. The study will evaluate the
safety and anti-tumor activity of telaglenastat plus palbociclib in
patients with KRAS-mutated colorectal cancer (CRC) and KRAS-mutated
non-small cell lung cancer (NSCLC).
- Advanced INCB001158
arginase inhibitor immuno-oncology program. INCB001158 is
being evaluated in multiple clinical trials for the treatment of
patients with cancer both as a monotherapy, and in combination with
immunotherapies and chemotherapy. INCB001158 is being developed as
part of a collaboration and license agreement with Incyte. Data
from INCB001158 are expected to be presented at the European
Society for Medical Oncology (ESMO) Congress in September.
- Presented new preclinical
data for CB-708 at AACR Annual Meeting. CB-708 is a
selective, oral inhibitor of CD73, an enzyme that synthesizes the
immunosuppressive agent adenosine and is over expressed in multiple
tumor types. By blocking adenosine production in the tumor, CB-708
is designed to enhance T-cell activation leading to anti-tumor
activity. Calithera anticipates that CB-708 will enter clinical
trials in the second half of 2019.
- Completed public offering
of common stock. In June 2019, Calithera completed an
underwritten public offering of common stock. Gross proceeds from
the offering, before underwriting discounts and commissions and
offering expenses, were $57.5 million.
Selected Second Quarter 2019 Financial
Results
Cash, cash equivalents and
investments totaled $153.2 million at June 30, 2019.
Research and development
expenses were $20.9 million for the three months ended
June 30, 2019, compared with $17.3 million for the same period in
the prior year. The increase of $3.6 million was primarily due to a
$1.5 million increase in the telaglenastat program, including for
the CANTATA trial, an increase of $1.5 million in the INCB001158
program, and an increase of $0.7 million in the CB-280 program,
partially offset by a decrease of $0.1 million for investment in
our early stage research programs.
General and administrative
expenses were $4.0 million for the three months ended June
30, 2019, compared with $3.5 million for the same period in the
prior year. The increase of $0.5 million was related to higher
professional services costs.
Net loss for the three months ended June 30,
2019 was $24.2 million, or $0.58 per share.
Conference Call Information
Calithera will host an update conference call
today, Thursday, August 8 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
9239839. 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 trial
design and enrollment of patients in the CANTATA and ENTRATA
trials; clinical trials for INCB001158 and Calithera’s agreement
with Incyte; 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 |
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|
|
|
(in thousands, except per share amounts) |
|
|
|
|
|
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(unaudited) |
|
|
|
|
|
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Three Months Ended June
30, |
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Six Months EndedJune
30, |
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|
2019 |
|
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|
2018 |
|
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|
2019 |
|
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
— |
|
|
$ |
17,065 |
|
|
$ |
— |
|
|
$ |
22,254 |
|
Total revenue |
|
— |
|
|
|
17,065 |
|
|
|
— |
|
|
|
22,254 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
20,928 |
|
|
|
17,305 |
|
|
|
41,167 |
|
|
|
32,798 |
|
General and administrative |
|
3,984 |
|
|
|
3,498 |
|
|
|
8,148 |
|
|
|
7,006 |
|
Total operating expenses |
|
24,912 |
|
|
|
20,803 |
|
|
|
49,315 |
|
|
|
39,804 |
|
Loss from operations |
|
(24,912 |
) |
|
|
(3,738 |
) |
|
|
(49,315 |
) |
|
|
(17,550 |
) |
Interest and other income, net |
|
760 |
|
|
|
663 |
|
|
|
1,476 |
|
|
|
1,269 |
|
Net loss |
$ |
(24,152 |
) |
|
$ |
(3,075 |
) |
|
$ |
(47,839 |
) |
|
$ |
(16,281 |
) |
Net loss per share, basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(0.09 |
) |
|
$ |
(1.19 |
) |
|
$ |
(0.45 |
) |
Weighted average common shares used to compute net loss per share,
basic and diluted |
|
41,303 |
|
|
|
35,874 |
|
|
|
40,091 |
|
|
|
35,827 |
|
|
|
|
|
|
|
|
|
|
Calithera Biosciences, Inc. |
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|
Selected Consolidated Balance Sheet Financial
Data |
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(in thousands) |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2019 |
|
2018 |
Balance Sheet
Data: |
|
|
|
Cash, cash equivalents and investments |
$ |
153,212 |
|
|
$ |
136,153 |
|
Working capital |
|
137,060 |
|
|
|
125,371 |
|
Total assets |
|
166,376 |
|
|
|
142,725 |
|
Total liabilities |
|
26,994 |
|
|
|
16,011 |
|
Accumulated deficit |
|
(244,080 |
) |
|
|
(196,170 |
) |
Total stockholders’ equity |
|
139,382 |
|
|
|
126,714 |
|
|
|
|
|
###
CONTACT: Jennifer McNealey
ir@Calithera.com 650-870-1071
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