Calithera Biosciences Provides Overview of 2020 Corporate Milestones and Financial Guidance
January 13 2020 - 7:07AM
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, provided today an overview of select
expected fourth quarter 2019 financial results, initial 2020
financial guidance and upcoming corporate milestones.
"We anticipate that 2020 will be an exciting year for Calithera,
building on the substantial progress we made in 2019 and the
potential for several significant clinical and regulatory
milestones," said Susan Molineaux, PhD, president and chief
executive officer of Calithera. "We remain in a strong financial
position to advance our key clinical programs and robust pipeline
this year, and we are pleased with our strong cash balance at the
end of 2019.”
2020 Milestones
Calithera expects to achieve the following milestones in
2020:
- Announce topline data from 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
445 patients at multiple centers globally. The primary endpoint is
progression-free survival. Calithera plans to report top-line
efficacy and safety data from the trial in the second half of
2020.
- Initiate Phase 2 trial of telaglenastat 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 regulation of reactive oxygen species in a
manner that is 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. 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
chemo-immunotherapy in first line NSCLC patients with tumors that
harbor mutations in either KEAP1 or NRF2 that activate this
pathway. This trial is expected to begin in the first half of
2020.
- Enroll telaglenastat (CB-839) combination trials in
collaboration with Pfizer. Calithera and Pfizer have two
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 glutaminase inhibitor
telaglenastat.
- Continue enrollment of multiple clinical trials
evaluating Calithera’s arginase inhibitor
INCB001158. INCB001158 is a small-molecule
immuno-oncology therapeutic being evaluated in multiple clinical
trials as a single-agent and in combination with immunotherapies
and chemotherapy for the treatment of patients with cancer.
INCB001158 is being developed as part of a collaboration and
license agreement with Incyte.
- Enroll clinical dose escalation trial evaluating
CB-280, an oral arginase inhibitor, in cystic fibrosis
(CF). 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. A
Phase 1b clinical study in people with 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 pharmacodynamics effects of
arginase inhibition in this population. Patients with any CF
transmembrane conductance regulator mutational status will be
eligible for the study.
Select Expected Fourth Quarter 2019 Financial Results
and Financial Guidance for 2020
Based upon preliminary estimates, cash, cash equivalents and
investments totaled $157.4 million at December 31, 2019.
Calithera expects to utilize cash and investments between $75 and
$85 million in 2020. The information relating to cash, cash
equivalents and investments is preliminary, has not been audited
and is subject to change upon completion of the audit of
Calithera’s financial statements as of and for the year ended
December 31, 2019.
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
expected operating results as of December 31, 2019, including cash,
cash equivalents and investments, the announcement of topline data
in Calithera’s CANTATA trial, the advancement of clinical programs
in 2020, the safety, tolerability and efficacy of Calithera’s
product candidates, the overall advancement of Calithera’s product
candidates in clinical trials, the unmet need in the treatment of
patients with advanced disease, and Calithera’s plans to continue
development of its product candidates. 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 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 most recent Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission, and
other 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.
CONTACT:
Jennifer McNealeyir@Calithera.com650-870-1071 |
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