Calithera Biosciences Reports Second Quarter 2017 Financial Results and Recent Highlights
August 08 2017 - 4:06PM
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage
pharmaceutical company focused on discovering and developing novel
small molecule drugs directed against tumor metabolism and tumor
immunology targets for the treatment of cancer, announced today its
financial results for the second quarter ended June 30, 2017.
As of June 30, 2017, cash, cash equivalents and investments totaled
$208.2 million.
“Recent highlights included the presentation of clinical trial
results of CB-1158, a first-in-class small molecule arginase
inhibitor, in an oral presentation at the American Society of
Clinical Oncology, and the advancement of CB-839 into Phase 2
clinical trials in renal cell carcinoma and triple negative breast
cancer,” said Susan Molineaux, PhD, President and Chief Executive
Officer of Calithera. “Looking forward to the second half of
2017, we plan to present clinical updates on CB-839, including the
initial results of CB-839 dosed in combination with Bristol Myers
Squibb’s Opdivo® (nivolumab) in the fourth quarter.”
Second Quarter 2017 and Recent Highlights
- CB-839 Randomized Phase 2 Combination Trial in Renal
Cell Carcinoma Initiated. In August 2017, Calithera
announced the initiation of a randomized, double blind, placebo
controlled trial to evaluate the safety and efficacy of CB-839 in
combination with everolimus versus placebo in approximately 250
patients with metastatic, clear cell renal cell carcinoma who have
been treated with at least two lines of prior systemic therapy
including a VEGFR-targeting tyrosine kinase inhibitor and at least
one of either CABOMETYX™ (cabozantinib) or an active PD-1/PD-L1
inhibitor. CB-839 has been granted Fast Track designation for
this indication.
- CB-839 Triple Negative Breast Cancer Phase 2 Trial
Initiated. In July 2017, Calithera
initiated a Phase 2 trial of CB-839 with paclitaxel in triple
negative breast cancer patients. Four single arm, open label,
cohorts of African American and non-African American patients will
be treated in both the early stage setting, where patients have no
prior treatment for metastatic disease, as well as the late stage
setting, after at least two prior therapies for metastatic
disease including prior taxane therapy. The primary endpoint
of this trial is objective response rate. Additional data
from the triple negative breast cancer development program are
expected in the fourth quarter of 2017.
- Collaboration with Bristol-Myers Squibb
expanded. In May 2017, Calithera’s existing
collaboration evaluating Opdivo® (nivolumab) in combination with
CB-839 was expanded to include additional renal cell carcinoma
cohorts as well as non-small cell lung cancer and melanoma.
Initial results of CB-839 dosed in combination with Bristol Myers
Squibb’s Opdivo® are expected in the fourth quarter of 2017.
- CB-1158 (INCB01158) Phase I Solid Tumor Data Presented
at the American Society of Clinical Oncology Annual
Meeting. In June 2017, data was presented from the
first 17 patients with advanced solid tumors dosed with CB-1158 as
a single agent. Plasma levels of arginase were inhibited > 90%
in all patients, and in 10 of 11 patients plasma arginine increased
1.5-fold or more. CB-1158 was generally well tolerated with
no drug-related serious adverse events. The trial is continuing to
enroll patients in the dose escalation phase of the study, and
expansion cohorts in pre-defined tumor types, to be followed by
combination studies with an anti-PD-1 antibody.
Selected Second Quarter 2017 Financial
Results
Cash, cash equivalents and investments totaled
$208.2 million at June 30, 2017, compared with $207.1 million at
March 31, 2017. During the second quarter of 2017, Calithera
received payment of a $12.0 million milestone under its global
collaboration and license agreement with Incyte.
Revenue was $7.3 million for the three months
ended June 30, 2017 and represents the portion of deferred revenue
recognized in the second quarter from the Company’s collaboration
and license agreement with Incyte.
Research and development expenses were $10.1
million for the three months ended June 30, 2017, compared with
$7.8 million for the same period in the prior year. The
increase of $2.3 million was primarily due to an increase in the
CB-839 program, including for Phase 2 start-up activities, as well
as investment in our early stage research programs, partially
offset by decreases in the CB-1158 program including Incyte’s
co-funding of development costs.
General and administrative expenses were $2.8
million for the three months ended June 30, 2017, compared with
$2.7 million for the same period in the prior year. The
increase of $0.1 million was primarily due to increases in
professional services and higher personnel-related costs.
Net loss from operations for the three months ended June 30,
2017 was $5.2 million, or $0.15 per share.
Conference Call Information
Calithera will host an update conference call today, August 8th
at 1:30 p.m. Pacific Time/ 4:30 p.m. Eastern Time. The call
can be accessed by dialing (855) 783-2599 (domestic) or (631)
485-4877 (international), and referring to conference ID
63329558. 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, Inc. is a clinical-stage pharmaceutical
company focused on discovering and developing novel small molecule
drugs directed against tumor metabolism and tumor immunology
targets for the treatment of cancer. Calithera’s lead product
candidate, CB-839, is a potent, selective, reversible and orally
bioavailable inhibitor of glutaminase. CB-839 takes advantage of
the pronounced dependency many cancers have on the nutrient
glutamine for growth and survival. It is currently being evaluated
in Phase 2 clinical trials in combination with standard of care
agents. CB-1158 is a first-in-class immuno-oncology metabolic
checkpoint inhibitor targeting arginase, a critical
immunosuppressive enzyme responsible for T-cell suppression by
myeloid-derived suppressor cells. Arginase depletes arginine,
a nutrient that is critical for the activation, growth and survival
of the body’s cancer-fighting immune cells, known as cytotoxic
T-cells. CB-1158 is being developed in collaboration with
Incyte Corporation and is currently in a Phase 1 clinical
trial. 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 the
timing of Calithera’s clinical trials, the clinical and commercial
potential of its product candidates, Calithera’s ability to fund
its clinical programs, and Calithera’s receipt of clinical data
from its 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.
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Calithera Biosciences, Inc. |
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Selected 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
Ended June
30, |
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2017 |
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2016 |
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|
2017 |
|
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|
2016 |
|
Revenue: |
|
|
|
|
|
|
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Collaboration revenue |
$ |
7,255 |
|
|
$ |
— |
|
|
$ |
11,447 |
|
|
$ |
— |
|
Total
revenue |
|
7,255 |
|
|
|
— |
|
|
|
11,447 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
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Research
and development |
|
10,142 |
|
|
|
7,776 |
|
|
|
16,782 |
|
|
|
14,842 |
|
General
and administrative |
|
2,848 |
|
|
|
2,665 |
|
|
|
6,156 |
|
|
|
5,256 |
|
Total
operating expenses |
|
12,990 |
|
|
|
10,441 |
|
|
|
22,938 |
|
|
|
20,098 |
|
Loss
from operations |
|
(5,735 |
) |
|
|
(10,441 |
) |
|
|
(11,491 |
) |
|
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(20,098 |
) |
Interest
income, net |
|
541 |
|
|
|
83 |
|
|
|
710 |
|
|
|
158 |
|
Net
loss |
$ |
(5,194 |
) |
|
$ |
(10,358 |
) |
|
$ |
(10,781 |
) |
|
$ |
(19,940 |
) |
Net loss per share,
basic and diluted |
$ |
(0.15 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.07 |
) |
Weighted
average common shares used to compute net loss per share, basic and
diluted |
|
35,348 |
|
|
|
18,987 |
|
|
|
30,342 |
|
|
|
18,688 |
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Calithera Biosciences, Inc. |
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Selected Balance Sheets Financial Data |
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(in thousands) |
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(unaudited) |
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June 30, |
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December 31, |
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2017 |
|
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|
2016 |
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Balance Sheet
Data: |
|
|
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Cash,
cash equivalents and investments |
$ |
208,184 |
|
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$ |
51,781 |
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Working
capital |
|
135,953 |
|
|
|
49,108 |
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Total
assets |
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214,082 |
|
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|
54,796 |
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Deferred
revenue |
|
45,553 |
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|
|
— |
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Total
liabilities |
|
51,618 |
|
|
|
4,890 |
|
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Accumulated deficit |
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(133,287 |
) |
|
|
(122,502 |
) |
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Total
stockholders’ equity |
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162,464 |
|
|
|
49,906 |
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Contact:
Jennifer McNealey
ir@Calithera.com
650-870-1071
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