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 months ended March 31, 2019 and provides highlights
of progress within the development pipeline.
“I am pleased with the pace of our accomplishments so far in
2019 as we continue to enroll subjects in both our ESCaPE-CMD study
in the U.S. for CLBS14-CMD and our CLI study in Japan for CLBS12,”
stated David J. Mazzo, Ph.D., President and Chief Executive Officer
of Caladrius. “The preliminary data for both studies are very
promising and we expect to report top-line results for ESCaPE-CMD
by the end of 2019 and for CLBS12 in the first half of 2020. In
addition, we continue to work closely with the U.S Food and Drug
Administration on the protocol design for our no-option refractory
disabling angina (“NORDA”) program and have targeted initiation of
that Phase 3 study before the end of 2019.”
“We look forward to building on the momentum we have created in
advancing our clinical development pipeline and reporting on a
number of important, value-creating milestones throughout the
balance of this year,” concluded Dr. Mazzo.
First Quarter Financial Highlights
Research and development expenses for the first quarter of 2019
were $2.0 million, a 10% decrease compared with $2.3 million for
the first 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 critical limb ischemia development program in
Japan, (ii) expense associated with our ongoing Phase 1b/2a study
for CLBS14-CMD in coronary microvascular dysfunction, and (iii)
expenses associated with the planning of our CLBS14-NORDA program
in refractory angina.
General and administrative expenses, which focus on general
corporate related activities, were $2.6 million for the first
quarter of 2019, a 12% decrease compared with $2.9 million for the
first quarter of 2018.
The net loss for the first quarter of 2019 was $4.4 million, or
$0.44 per share, compared with $5.0 million, or $0.52 per share,
for the first quarter of 2018.
Balance Sheet Highlights
As of March 31, 2019, Caladrius had cash, cash equivalents and
marketable securities of $38.4 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 beginning at
4:30 p.m. ET on Thursday, May 9, 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: 2576003.
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 May 16, 2019. To access the audio replay, dial
(855) 859-2056 (domestic) or (404) 537-3406 (international) and
provide conference ID number: 2576003.
A webcast replay of the conference call will remain available on
the Company’s website for 90 days.
About Caladrius Biosciences Inc.
Caladrius 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
Phase 2 testing in Japan and eligible for early conditional
approval for the treatment of critical limb ischemia; CLBS14-CMD,
subject of the proof-of-concept ESCaPE-CMD clinical trial in the
U.S.A. for the treatment of coronary microvascular dysfunction; and
CLBS14-NORDA, recipient of a RMAT designation in the U.S.A. and for
which we are in preparations 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 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
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 March
31, |
|
|
(in thousands, except per share data) |
2019 |
|
2018 |
|
|
Statement of Operations Data: |
|
|
|
|
|
Research and development |
$ |
2,038 |
|
|
$ |
2,262 |
|
|
|
General and administrative |
|
2,554 |
|
|
|
2,897 |
|
|
|
Total operating expenses |
|
4,592 |
|
|
|
5,159 |
|
|
|
Operating loss |
|
(4,592 |
) |
|
|
(5,159 |
) |
|
|
Other income (expense), net |
|
227 |
|
|
|
178 |
|
|
|
Interest expense |
|
- |
|
|
|
(3 |
) |
|
|
Net loss |
|
(4,365 |
) |
|
|
(4,984 |
) |
|
|
Less - net income (loss) attributable to noncontrolling
interests |
|
2 |
|
|
|
(2 |
) |
|
|
Net loss attributable to Caladrius Biosciences, Inc. common
stockholders |
$ |
(4,367 |
) |
|
$ |
(4,982 |
) |
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common stockholders |
$ |
(0.44 |
) |
|
$ |
(0.52 |
) |
|
|
Weighted average common shares outstanding |
|
10,027 |
|
|
|
9,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019 |
|
December 31, 2018 |
|
|
Balance Sheet Data: |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
38,370 |
|
|
$ |
43,053 |
|
|
|
Total assets |
|
41,288 |
|
|
|
44,580 |
|
|
|
Total liabilities |
|
6,830 |
|
|
|
7,126 |
|
|
|
Total equity |
|
34,458 |
|
|
|
37,454 |
|
|
|
|
|
|
|
|
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