Calithera Biosciences Reports Fourth Quarter 2018 Financial Results and Recent Highlights
March 07 2019 - 4:06PM
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 and year ended December 31, 2018. As of
December 31, 2018, cash, cash equivalents and investments totaled
$136.2 million.
“This is a time of significant progress for Calithera’s clinical
development program as we continue to advance our novel
onco-metabolism clinical candidates through robust clinical
studies,” said Susan M. Molineaux, PhD, president and chief
executive officer of Calithera. “In the fourth quarter, we
broadened development of the novel glutaminase inhibitor
telaglenastat through two new clinical trial collaborations with
Pfizer. We recently completed enrollment of the ENTRATA trial of
telaglenastat for the treatment of patients with renal cell
carcinoma. We anticipate that this momentum will continue in 2019
with data from the ENTRATA trial and, with our partner Incyte, data
from the INCB001158 program, both expected in the second half of
the year.”
Fourth Quarter 2018 and Recent Highlights
- Completed patient enrollment in the randomized phase 2
ENTRATA trial of telaglenastat (CB-839) and everolimus in renal
cell carcinoma (RCC). 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 a 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 efficacy and safety data
from the trial in the second half of 2019.
- Announced two new clinical trial collaborations to
evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as
IBRANCE®, and the dual-mechanism poly (ADP-ribose) polymerase
(PARP) inhibitor talazoparib, also known as TALZENNA®, each in
combination with Calithera’s glutaminase inhibitor
telaglenastat. Preclinical data suggest that telaglenastat
synergizes with PARP inhibitors to impair DNA synthesis, enhance
DNA damage, and block cancer cell proliferation. Calithera will
initiate a Phase 1/2 clinical trial of the combination of
telaglenastat plus talazoparib in patients with RCC and TNBC in the
first quarter of 2019. Telaglenastat also synergizes with CDK4/6
inhibitors by enhancing cell cycle arrest and blocking cancer cell
proliferation. Calithera will initiate a Phase 1/2 clinical trial
of the combination of telaglenastat plus palbociclib in patients
with KRAS-mutated colorectal cancer (CRC) and patients with
KRAS-mutated non-small cell lung cancer (NSCLC) in the second
quarter of 2019.
- 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 the
INCB001158 program are expected to be presented at a medical
meeting in the second half 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. The study will be conducted under a United States Food
and Drug Administration (FDA) Investigational New Drug (IND)
application.
- Initiated IND-enabling studies with CB-708, an oral
small molecule CD73 inhibitor. The immuno-oncology target
CD73 is an enzyme that plays a critical role in the process of ATP
conversion to adenosine. Initiation of a Phase 1 study of CB-708,
an orally administered small molecule inhibitor of CD73, is planned
for 2019. A preclinical abstract describing CB-708 has been
accepted for presentation at the 2019 American Association for
Cancer Research annual meeting in March.
Selected Fourth Quarter 2018 Financial
Results
Cash, cash equivalents and investments totaled
$136.2 million at December 31, 2018.
Collaboration revenue for the full year 2018
was $22.2 million, compared with $26.0 million in the prior year.
In June 2018, we completed the manufacturing services and
technology transfer under our collaboration and license agreement
with Incyte, which satisfied the performance obligation under ASC
606, and as a result, all remaining deferred revenue was
recognized.
Research and development expenses for the full
year 2018 were $66.2 million, compared with $43.1 million in the
prior year. The increase of $23.1 million was due to an increase in
the telaglenastat program to support our new and ongoing clinical
trials, including for our Phase 2 CANTATA trial which opened in
2018, increases in the INCB001158 and CB-280 programs, as well as
investment in early stage research. Research and development
expenses for the fourth quarter of 2018 were $17.0 million,
compared to $15.5 million for the same period last year.
General and administrative expenses for the
full year 2018 were $13.3 million, compared with $12.5 million in
the prior year. The increase of $0.8 million in 2018 was primarily
due to higher personnel-related costs to support our clinical
trials, offset partially by lower outside professional services,
including activities related to our Incyte collaboration and
license agreement and sublease in 2017. General and administrative
expenses for the fourth quarter of 2018 were $3.2 million, compared
to $3.3 million for the same period last year.
Interest Income, net for the full year 2018 was
$2.7 million, compared with $1.9 million in the prior year. The
increase of $0.8 million related to higher returns on our
investments, partially offset by lower cash equivalents and
investment balances. Interest income, net for the fourth quarter of
2018 was $0.7 million, compared to $0.6 million for the same period
last year.
Net loss from operations for the three months and year ended
December 31, 2018 was $19.5 million and $54.6 million,
respectively.
Conference Call Information
Calithera will host an update conference call today, Thursday,
March 7th at 4:30 p.m. Eastern Time/ 1:30 p.m. Pacific Time. The
call may be accessed by dialing (855) 783-2599 (domestic) or (631)
485-4877 (international), and referring to conference ID 9577446.
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 is a clinical-stage biopharmaceutical company focused
on fighting cancer by discovering, developing, and commercializing
novel small molecule drugs that target tumor and immune cell
metabolism. 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 safety, tolerability and efficacy
of CB-839, INCB001158, CB-280 and CB-708, and the overall
advancement in clinical trials, Calithera’s collaborations with
Incyte and Pfizer, 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.
Calithera Biosciences, Inc. |
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Selected Consolidated Statements of Operations Financial
Data |
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|
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended
December 31, |
|
Twelve Months EndedDecember
31, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenue: |
|
|
|
|
|
|
|
Collaboration
revenue |
$ |
— |
|
|
$ |
7,254 |
|
|
$ |
22,254 |
|
|
$ |
25,955 |
|
Total
revenue |
|
— |
|
|
|
7,254 |
|
|
|
22,254 |
|
|
|
25,955 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
16,977 |
|
|
|
15,496 |
|
|
|
66,195 |
|
|
|
43,111 |
|
General and administrative |
|
3,247 |
|
|
|
3,300 |
|
|
|
13,340 |
|
|
|
12,530 |
|
Total
operating expenses |
|
20,224 |
|
|
|
18,796 |
|
|
|
79,535 |
|
|
|
55,641 |
|
Loss
from operations |
|
(20,224 |
) |
|
|
(11,542 |
) |
|
|
(57,281 |
) |
|
|
(29,686 |
) |
Interest
income, net |
|
725 |
|
|
|
568 |
|
|
|
2,652 |
|
|
|
1,860 |
|
Net
loss |
$ |
(19,499 |
) |
|
$ |
(10,974 |
) |
|
$ |
(54,629 |
) |
|
$ |
(27,826 |
) |
Net loss per share,
basic and diluted |
$ |
(0.51 |
) |
|
$ |
(0.31 |
) |
|
$ |
(1.49 |
) |
|
$ |
(0.84 |
) |
Weighted
average common shares used to compute net loss per share, basic and
diluted |
|
38,333 |
|
|
|
35,560 |
|
|
|
36,604 |
|
|
|
32,951 |
|
|
|
|
|
|
|
|
|
Calithera Biosciences, Inc. |
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Selected Consolidated Balance Sheet Financial
Data |
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(in thousands) |
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(unaudited) |
|
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|
|
|
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|
December 31, |
|
December 31, |
|
2018 |
|
2017 |
Balance Sheet
Data: |
|
|
|
Cash, cash equivalents
and investments |
$ |
136,153 |
|
|
$ |
186,154 |
|
Working
capital |
|
125,371 |
|
|
|
128,640 |
|
Total
assets |
|
142,725 |
|
|
|
192,455 |
|
Deferred
revenue |
|
— |
|
|
|
31,045 |
|
Total
liabilities |
|
16,011 |
|
|
|
42,148 |
|
Accumulated deficit |
|
(196,170 |
) |
|
|
(150,333 |
) |
Total
stockholders’ equity |
|
126,714 |
|
|
|
150,307 |
|
|
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Contact:Jennifer
McNealeyir@Calithera.com650-870-1071
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