Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a clinical-stage biopharmaceutical company dedicated to
the development of cellular therapies designed to reverse, not
manage, cardiovascular disease, announces financial results for the
three and twelve months ended December 31, 2019.
“I am pleased with the Company’s many
achievements throughout 2019 as we made significant progress
advancing our CD34+ technology-based clinical programs while
maintaining strict financial controls,” stated David J. Mazzo,
Ph.D., President and Chief Executive Officer of Caladrius.
“Notably, in November at the American Heart Association Scientific
Sessions 2019, we reported the data for those patients (17 of 20)
who, at that time, had completed their six-month follow-up visit in
our ESCaPE-CMD study of CLBS16. The results showed highly
statistically significant improvement in coronary flow reserve
(“CFR”) correlating with angina symptom relief for patients with
coronary microvascular dysfunction (“CMD”) after a single
administration of CLBS16. To our knowledge, this is the first
therapy to show the ability to durably increase CFR and potentially
reverse CMD after a single administration. We look forward to
reporting the full study data in the first half of 2020 in an
appropriate forum. In Japan, enrollment continues to progress for
the study of CLBS12 in critical limb ischemia (“CLI”), and we
anticipate completing enrollment in the first half of 2020. Current
data in both the no-option CLI and Buerger’s Disease cohorts of
that study (the latter cohort has been fully enrolled and data are
available in our corporate presentation) remain corroborative of
previously published results, which we believe are an indication of
a high probability of clinical success of the trial. We continue to
anticipate top line data for the full study in early 2021 leading
to an earliest possible approval in Japan in late 2021 or early
2022. Finally, we have completed all preparatory measures for the
initiation of the single confirmatory phase 3 study agreed with
U.S. Food and Drug Administration (the "FDA") to conclude
development of CLBS14 in no-option refractory disabling angina
(NORDA) and are awaiting finalization of a funding plan before
commencing the trial.
“We are excited about what lies ahead in 2020
and expect to build on this momentum as we continue to advance our
clinical development pipeline and strive to achieve a number of
important development milestones throughout the balance of the
year,” concluded Dr. Mazzo.
Fourth Quarter and Full Year 2019
Financial Highlights
Research and development expenses for the fourth
quarter of 2019 were $2.8 million, an 84% increase compared with
$1.5 million for the fourth quarter of 2018, and $10.8 million for
2019, a 42% increase compared with $7.6 million for 2018. Research
and development in both the current year and prior year periods
focused on the advancement of our ischemic repair platform and
related to:
- ongoing registration-eligible study
expenses for CLBS12 in critical limb ischemia in Japan, whereby we
continue to focus spending on our patient enrollment;
- ongoing Phase 2 proof-of-concept
study expenses for CLBS16 in coronary microvascular dysfunction,
for which study enrollment was completed in the second quarter of
2019; and
- expenses associated with
preparation of our confirmatory Phase 3 study of CLBS14 in NORDA.
In late 2019, we projected that the Phase 3 study would cost
approximately $70 million in external expenses over the next
several years to complete, and as a result, we elected to postpone
the initiation of the study until we have confidence that we can
access sufficient capital to allow us to complete the study
uninterrupted
General and administrative expenses, which focus
on general corporate related activities, were approximately $2.3
million for both the fourth quarters of 2019 and 2018, and $9.3
million for 2019, a slight decline compared to $9.4 million in
2018.
The net loss for the fourth quarter of 2019 was
$5.0 million, or $0.47 per share, compared with $3.6 million, or
$0.36 per share, for the fourth quarter of 2018. The net loss for
2019 was $19.4 million, or $1.88 per share, compared with $16.2
million, or $1.67 per share, for 2018.
Balance Sheet Highlights
As of December 31, 2019, Caladrius had cash,
cash equivalents and marketable securities of $25.2 million. Based
on existing programs and projections, the Company remains confident
that its cash balances will fund its operations through at least
the second quarter of 2021.
Conference Call
Caladrius’ management will host a conference
call for the investment community later today, March 5, 2020, at
4:30 p.m. (ET) to discuss the financial results, provide a company
update and answer questions.
Shareholders and other interested parties may
participate on the conference call by dialing (866) 595-8403 (U.S.)
or (706) 758-9979 (International), using the conference ID code:
4155934. The live webcast will be accessible via the Events page
listed under the Investor section of the Company’s website at
www.caladrius.com/investors/news-events/events.
For those unable to participate on the live
conference call, an audio replay will be available approximately
two hours after the conclusion of the call until 11:59 p.m. ET on
March 12, 2020. To access the replay, please dial (855) 859-2056
(U.S.) or (404) 537-3406 (International) and provide the conference
ID code: 4155934.
A webcast replay of the conference call will
remain available on the Company’s website for 90 days.
About Caladrius
BiosciencesCaladrius Biosciences, Inc. is a clinical-stage
biopharmaceutical company dedicated to the development of cellular
therapies designed to reverse, not manage, cardiovascular disease.
We are developing a first in-class cell therapy product that is
based on the notion that our body contains finely tuned mechanisms
for self-repair. Our technology leverages and enables these
mechanisms in the form of specific cells, using formulations and
modes of delivery unique to each medical indication.
Our leadership team collectively has decades of
biopharmaceutical development experience and world-recognized
scientific achievement in the field of cardiovascular disease,
among other fields. Our goal is to build a broad portfolio of novel
and versatile products that address important unmet medical needs
and bring these products to market to benefit patients, the medical
community and our shareholders. Our current product candidates
include three developmental treatments for ischemic diseases based
on our CD34+ cell therapy platform: CLBS12, recipient of SAKIGAKE
designation (a Japanese regulatory status that is similar in
certain respects to "breakthrough therapy" designation granted by
the U.S. Food and Drug Administration (the "FDA") to eligible
investigational treatments) and eligible for early conditional
approval in Japan for the treatment of critical limb ischemia
("CLI") based on the results of an ongoing clinical trial; CLBS16,
in a Phase 2 proof-of-concept clinical trial in the U.S. for the
treatment of coronary microvascular dysfunction ("CMD"); and
CLBS14, an RMAT designated therapy for which we have finalized with
the FDA a protocol for a Phase 3 confirmatory trial in subjects
with no-option refractory disabling angina ("NORDA"). For more
information on the company, please
visit www.caladrius.com.
Safe Harbor for Forward Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements reflect management’s
current expectations, as of the date of this press release, and
involve certain risks and uncertainties. All statements other than
statements of historical fact contained in this press release are
forward-looking statements including, without limitation, all
statements related to any expectations of revenues, expenses,
cash flows, earnings or losses from operations, cash required to
maintain current and planned operations, capital or other financial
items; any statements of the plans, strategies and objectives of
management for future operations; any plans or expectations with
respect to product research, development and commercialization,
including regulatory approvals; any other statements of
expectations, plans, intentions or beliefs; and any statements of
assumptions underlying any of the foregoing. Without limiting the
foregoing, the words “plan,” “project,” “forecast,” “outlook,”
“intend,” “may,” “will,” “expect,” “likely,” “believe,” “could,”
“anticipate,” “estimate,” “continue” or similar expressions or
other variations or comparable terminology are intended to identify
such forward-looking statements, although some forward-looking
statements are expressed differently. Factors that could cause
future results to differ materially from the recent results or
those projected in forward-looking statements include the “Risk
Factors” described in the Company’s Annual Report on Form 10-K
filed with the Securities and Exchange Commission (“SEC”) on March
5, 2019 and in the Company’s other periodic filings with the SEC.
The Company’s further development is highly dependent on, among
other things, future medical and research developments and market
acceptance, which are outside of its control. You are cautioned not
to place undue reliance on forward-looking statements, which speak
only as of the date of this Press Release. Caladrius does not
intend, and disclaims any obligation, to update or revise any
forward-looking information contained in this Press Release or with
respect to the matters described herein.
Contact:
Investors: Caladrius Biosciences, Inc. John
Menditto Vice President, Investor Relations and Corporate
Communications Phone: +1-908-842-0084
Email: jmenditto@caladrius.com
Media: W2O Group Christiana Pascale Phone:
+1-212-257-6722 Email: cpascale@w2ogroup.com
- Tables to Follow -
Caladrius Biosciences,
Inc.Selected Financial Data
(unaudited)(in thousands, except per share
data)
|
Three Months Ended December 31, |
|
|
|
Twelve Months Ended December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
(in
thousands, except per share data) |
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
2,767 |
|
|
1,507 |
|
|
$ |
10,797 |
|
|
$ |
7,594 |
|
General and administrative |
2,316 |
|
|
2,288 |
|
|
9,295 |
|
|
9,393 |
|
Total operating expenses |
5,083 |
|
|
3,795 |
|
|
20,092 |
|
|
16,987 |
|
Operating loss |
(5,083 |
) |
|
(3,795 |
) |
|
(20,092 |
) |
|
(16,987 |
) |
Investment income, net |
129 |
|
|
239 |
|
|
740 |
|
|
824 |
|
Interest expense |
- |
|
|
- |
|
|
- |
|
|
(5 |
) |
Net loss |
(4,954 |
) |
|
(3,556 |
) |
|
(19,352 |
) |
|
(16,168 |
) |
Less - net income (loss) attributable to noncontrolling
interests |
3 |
|
|
1 |
|
|
9 |
|
|
(1 |
) |
Net loss attributable to Caladrius Biosciences, Inc. common
stockholders |
$ |
(4,957 |
) |
|
$ |
(3,557 |
) |
|
$ |
(19,361 |
) |
|
$ |
(16,167 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common stockholders |
$ |
(0.47 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.88 |
) |
|
$ |
(1.67 |
) |
Weighted average common shares outstanding |
10,460 |
|
|
9,853 |
|
|
10,325 |
|
|
9,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019 |
|
|
December 31, 2018 |
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
|
|
$ |
25,157 |
|
|
$ |
43,053 |
|
Total assets |
|
|
|
|
|
|
27,153 |
|
|
44,580 |
|
Total liabilities |
|
|
|
|
|
|
6,600 |
|
|
7,126 |
|
Total equity |
|
|
|
|
|
|
20,553 |
|
|
37,454 |
|
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