Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a late-stage therapeutics development biopharmaceutical
company pioneering advancements of cell therapies in select
cardiovascular and autoimmune diseases, announces financial results
for the three and six months ended June 30, 2019 and provides
highlights of progress within the development pipeline.
“I am delighted to announce that, after close collaboration with
the U.S. Food and Drug Administration, we have finalized the
protocol design for a confirmatory Phase 3 trial of CLBS14 in
no-option refractory disabling angina (“NORDA”). We now plan
to initiate enrollment in this trial in early 2020,” stated David
J. Mazzo, Ph.D., President and Chief Executive Officer of
Caladrius. “The protocol defines a prospective, randomized,
double blind, ~400 total subject trial with a primary endpoint of
total exercise time at the 6-month follow-up visit.”
Dr. Mazzo continued, “We also recently announced that the
European Medicines Agency granted CLBS12 the Advanced Therapy
Medicinal Product classification for the treatment of critical limb
ischemia (“CLI”). As a result, we now have the opportunity to work
closely with the European regulators to define a path forward that
would accelerate the approval of CLBS12’s registration to treat CLI
in Europe. Finally, the preliminary data from our clinical
programs studying our CD34+ cell therapy platform for coronary
microvascular dysfunction (“CMD”) in the United States and CLI in
Japan, continue to trend positively and we reiterate our
expectations to report top-line data by the end of 2019 and early
2020, respectively.”
Second Quarter Financial Highlights
Research and development expenses for the second quarter of 2019
were $3.0 million, a 41% increase compared with $2.1 million for
the second quarter of 2018. Research and development in both
periods focused on the advancement of our ischemic repair platform
and related to (i) expenses associated with our ongoing Phase 2
study of CLBS12 in CLI development program in Japan, (ii) expense
associated with our ongoing Phase 2 clinical study for CLBS16 in
CMD, and (iii) expenses associated with the planning and
preparation for Phase 3 enrollment initiation of our CLBS14 program
in NORDA.
General and administrative expenses, which focus on general
corporate related activities, were $2.4 million for the second
quarter of 2019, a 10% increase compared with $2.1 million for the
second quarter of 2018.
The net loss for the second quarter of 2019 was $5.1 million, or
$0.49 per share, compared with $4.1 million, or $0.42 per share,
for the second quarter of 2018.
Six Month Financial Highlights
Research and development expenses for the first six months of
2019 were $5.0 million, a 15% increase compared with $4.4 million
for the first six months of 2018. Research and development in
both periods focused on the advancement of our ischemic repair
platform and related to (i) expenses associated with our ongoing
Phase 2 study of CLBS12 in CLI development program in Japan, (ii)
expense associated with our ongoing Phase 2 clinical study for
CLBS16 in CMD, and (iii) expenses associated with the planning and
preparation for Phase 3 enrollment initiation of our CLBS14 program
in NORDA.
General and administrative expenses, which focus on general
corporate related activities, were $4.9 million for the first six
months of 2019, a 3% decrease compared with $5.0 million for the
first six months of 2018.
The net loss for the first six months of 2019 was $9.5 million,
or $0.93 per share, compared with $9.1 million, or $0.95 per share,
for the first six months of 2018.
Balance Sheet Highlights
As of June 30, 2019, Caladrius had cash, cash equivalents and
marketable securities of $33.7 million. Based on existing
programs and projections, the Company remains confident that its
cash balances will allow it to fund its current business plan
through the second quarter of 2020.
Conference Call
Caladrius’ management will host a conference call for the
investment community beginning at 4:30 p.m. ET on Thursday, August
8, 2019 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 (domestic) or (706)
758-9979 (international), using the conference ID number: 4491545.
The conference call will also be webcast live and can be accessed
from the Company’s website at
www.caladrius.com/investors/news-events.
For those unable to participate in the live conference call or
webcast, an audio recording will be available for replay
approximately two hours after the conclusion of the call until
11:59 p.m. ET on August 15, 2019. To access the audio replay, dial
(855) 859-2056 (domestic) or (404) 537-3406 (international) and
provide conference ID number: 4491545.
A webcast replay of the conference call will remain available on
the Company’s website for 90 days.
About Caladrius BiosciencesCaladrius is a
late-stage therapeutics development biopharmaceutical company
pioneering advancements of cell therapies for select cardiovascular
and autoimmune diseases. Our leadership team collectively has
decades of biopharmaceutical development experience and
world-recognized scientific achievement in the fields of
cardiovascular and autoimmune disease, among other areas. Our
current product candidates include three developmental treatments
for cardiovascular diseases based on our CD34+ cell therapy
platform: CLBS12, recipient of a SAKIGAKE designation in Japan and
advanced therapy medicinal product classification (ATMP) in Europe,
eligible for early conditional approval for the treatment of
critical limb ischemia in Japan based on an ongoing clinical trial;
CLBS16, subject of the proof-of-concept ESCaPE-CMD clinical trial
in the U.S.A. for the treatment of coronary microvascular
dysfunction; and CLBS14, recipient of a RMAT designation in the
U.S.A. and for which we are in preparation to commence a Phase 3
clinical trial in no option refractory disabling angina. For more
information on the company, please
visit www.caladrius.com.
Safe Harbor for Forward Looking StatementsThis
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
14, 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
- Tables to Follow -
Caladrius Biosciences, Inc. |
Selected Financial Data (unaudited) |
(in thousands, except per share data) |
|
Three Months Ended June 30, |
|
Six Months Ended June
30, |
(in thousands, except per share data) |
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Statement of Operations Data: |
|
|
|
|
|
|
|
Research and development |
|
2,988 |
|
|
|
2,123 |
|
|
$ |
5,026 |
|
|
$ |
4,385 |
|
General and administrative |
|
2,358 |
|
|
|
2,146 |
|
|
|
4,912 |
|
|
|
5,043 |
|
Total operating expenses |
|
5,346 |
|
|
|
4,269 |
|
|
|
9,938 |
|
|
|
9,428 |
|
Operating loss |
|
(5,346 |
) |
|
|
(4,269 |
) |
|
|
(9,938 |
) |
|
|
(9,428 |
) |
Other income (expense), net |
|
209 |
|
|
|
194 |
|
|
|
436 |
|
|
|
371 |
|
Interest expense |
|
- |
|
|
|
(2 |
) |
|
|
- |
|
|
|
(5 |
) |
Net loss |
|
(5,137 |
) |
|
|
(4,077 |
) |
|
|
(9,502 |
) |
|
|
(9,062 |
) |
Less - net income (loss) attributable to noncontrolling
interests |
|
3 |
|
|
|
(1 |
) |
|
|
5 |
|
|
|
(3 |
) |
Net loss attributable to Caladrius Biosciences, Inc. common
stockholders |
$ |
(5,140 |
) |
|
$ |
(4,076 |
) |
|
$ |
(9,507 |
) |
|
$ |
(9,059 |
) |
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common stockholders |
$ |
(0.49 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.93 |
) |
|
$ |
(0.95 |
) |
Weighted average common shares outstanding |
|
10,393 |
|
|
|
9,592 |
|
|
|
10,211 |
|
|
|
9,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2019 |
|
December 31, 2018 |
Balance Sheet Data: |
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
$ |
33,655 |
|
|
$ |
43,053 |
|
Total assets |
|
|
|
|
|
36,350 |
|
|
|
44,580 |
|
Total liabilities |
|
|
|
|
|
6,728 |
|
|
|
7,126 |
|
Total equity |
|
|
|
|
|
29,622 |
|
|
|
37,454 |
|
|
|
|
|
|
|
|
|
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