-Strong quarter-end cash position of $207.1
million supports advancement of multiple clinical development
programs-Calithera to Host Conference Call Today at 1:30 p.m.
Pacific Time/ 4:30 p.m. Eastern Time
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 first quarter ended March 31, 2017.
As of March 31, 2017, cash, cash equivalents and investments
totaled $207.1 million.
“During the first quarter, we significantly strengthened the
company’s financial position and we believe we are well positioned
to execute on our strategy. Our collaboration and license
agreement with Incyte maximizes the clinical and commercial
potential of CB-1158, and we are pleased to have achieved the first
milestone in March,” said Susan Molineaux, PhD, President and Chief
Executive Officer of Calithera. “Looking forward to 2017, we
are on track to highlight new clinical data from each of our
clinical programs at scientific meetings, including an oral
presentation of CB-1158 data at the American Society of Clinical
Oncology in June, and multiple clinical updates on CB-839 in renal
cell carcinoma and triple negative breast cancer in the second half
of 2017. We also plan to present initial results of CB-839
dosed in combination with Bristol Myers Squibb’s Opdivo®.”
First Quarter 2017 and Recent Highlights
- CB-1158 Global Research, Development and
Commercialization Collaboration with Incyte. In
January 2017, Incyte and Calithera announced the global
collaboration and license agreement for the research, development
and commercialization of the first in class, small molecule
arginase inhibitor CB-1158. Under the terms of the
collaboration and license agreement, Calithera received an up-front
payment of $45.0 million from Incyte in addition to an $8.0 million
equity investment. CB-1158 entered clinical trials in
September 2016 and a $12.0 million pharmacodynamic and
pharmacokinetic milestone was achieved in March 2017. Payment of
the milestone was received in the second quarter of 2017.
- CB-1158 Data Accepted for Oral
Presentation. Data from the Phase 1 solid tumor trial has
been accepted for oral presentation at the 2017 American Society of
Clinical Oncology (ASCO) annual meeting. Clinical results to
be presented in an oral presentation on June 5 include monotherapy
data from Calithera’s Phase 1 trial in solid tumors.
- CB-839 Enrollment Continues in Renal
Cell Carcinoma and Triple Negative Breast Cancer.
Calithera continues to enroll patients in combination trials
in renal cell carcinoma and triple negative breast cancer, with
updates from each of these trials expected in the second half of
2017. Phase 2 trials are expected to begin the second half of
2017 in both renal cell carcinoma and triple negative breast
cancer. In addition, initial results of CB-839 dosed in
combination with Bristol Myers Squibb’s Opdivo are expected in the
second half of 2017.
- Completed Public Offering of Common Stock. In
March 2017, Calithera completed an underwritten public offering of
common stock, raising gross proceeds of $80.5 million.
- At-the-Market progam. In the first quarter of
2017, Calithera received $38.0 million in gross proceeds from the
sale of common stock pursuant to its at-the-market offering
program.
Selected First Quarter 2017 Financial
Results
Cash, cash equivalents and investments totaled
$207.1 million at March 31, 2017, compared with $51.8 million at
December 31, 2016. Calithera achieved a $12.0 million
milestone under its global collaboration and license agreement with
Incyte in March 2017, and payment was received in the second
quarter of 2017.
Revenue was $4.2 million for the three months
ended March 31, 2017 and represents the portion of deferred revenue
recognized in the first quarter from the Company’s collaboration
and license agreement with Incyte.
Research and development expenses were $6.6
million for the three months ended March 31, 2017, compared with
$7.1 million for the same period in the prior year. The
decrease of $0.5 million was primarily from the CB-1158 program,
including Incyte’s co-funding of development costs, partially
offset by an increase in the CB-839 program, including for Phase 2
start-up activities, as well as investment in our early stage
research programs.
General and administrative expenses were $3.3
million for the three months ended March 31, 2017, compared with
$2.6 million for the same period in the prior year. The
increase of $0.7 million was primarily due to costs associated with
the Incyte agreement and non-recurring expenses for the sublease of
office and laboratory space in March 2017.
Net loss from operations for the three months ended March 31,
2017 was $5.6 million, or $0.22 per share.
Revised Financial Guidance for 2017
Calithera expects that its cash, cash equivalents and
investments will be between $180 and $190 million at the end of
2017, exclusive of any funds arising from new collaborations or
partnerships, achievement of additional milestones, additional
equity financings or other new sources.
Conference Call Information
Calithera will host an update conference call today, May 9th 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 18046993. 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 1/2 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 initiation of Calithera’s clinical trials, the clinical
and commercial potential of CB-1158, the results of Calithera’s
collaboration with Incyte Corporation, Calithera’s ability to fund
its clinical programs, Calithera’s receipt of clinical data from
its clinical trials, and Calithera’s cash and investments balance
at the end of 2017. 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.
Calithera Biosciences, Inc. |
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Selected Balance Sheets Financial Data |
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|
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(in thousands) |
|
|
|
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(unaudited) |
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|
|
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|
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|
|
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March 31, |
|
December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
Balance Sheet
Data: |
|
|
|
|
Cash,
cash equivalents and investments |
$ |
207,070 |
|
|
$ |
51,781 |
|
|
Working
capital |
|
136,838 |
|
|
|
49,108 |
|
|
Total
assets |
|
223,908 |
|
|
|
54,796 |
|
|
Total
liabilities |
|
58,177 |
|
|
|
4,890 |
|
|
Accumulated deficit |
|
(128,094 |
) |
|
|
(122,502 |
) |
|
Total
stockholders’ equity |
|
165,731 |
|
|
|
49,906 |
|
|
|
|
|
|
|
Calithera Biosciences, Inc. |
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|
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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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|
|
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Three Months Ended March
31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
Revenue: |
|
|
|
|
Collaboration revenue |
$ |
4,192 |
|
|
$ |
— |
|
|
Total
revenue |
|
4,192 |
|
|
|
— |
|
|
Operating expenses: |
|
|
|
|
Research
and development |
|
6,640 |
|
|
|
7,066 |
|
|
General
and administrative |
|
3,308 |
|
|
|
2,591 |
|
|
Total
operating expenses |
|
9,948 |
|
|
|
9,657 |
|
|
Loss
from operations |
|
(5,756 |
) |
|
|
(9,657 |
) |
|
Interest
income, net |
|
169 |
|
|
|
75 |
|
|
Net
loss |
$ |
(5,587 |
) |
|
$ |
(9,582 |
) |
|
Net loss per share,
basic and diluted |
$ |
(0.22 |
) |
|
$ |
(0.52 |
) |
|
Weighted
average common shares used to compute net loss per share, basic and
diluted |
|
25,279 |
|
|
|
18,389 |
|
|
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|
Contact:
Jennifer McNealey
ir@Calithera.com
650-870-1071
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