Development programs remain on track
accompanied by continued strong fiscal management
Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a late-stage therapeutics development biopharmaceutical
company with multiple technology platforms targeting select
cardiovascular indications and autoimmune disease, announces
financial results for the three and nine months ended September 30,
2018, and provides a business update.
Highlights of the 2018 third quarter and early
fourth quarter include:
- Continued enrollment in a Phase 2
(SAKIGAKE designated and eligible for early conditional approval)
clinical trial in Japan of CLBS12 for the treatment of no-option
critical limb ischemia (“CLI”), including completion of enrollment
of the five patient Buerger’s disease cohort;
- Continued enrollment in a Phase 2
clinical trial using the CD34 cell therapy CLBS14-CMD for the
treatment of coronary microvascular dysfunction (“CMD”);
- Continued follow-up analysis of The
Sanford Project: T-Rex Study Phase 2 clinical trial of CLBS03 in
type 1 diabetes after completing enrollment and reporting six-month
results on 50% of trial subjects in the first quarter of 2018 that
concluded the treatment is well-tolerated and non-futile for
therapeutic effect; and
- Conducted a Type B meeting with the US
Food and Drug Administration (“FDA”) under the provisions of the
RMAT designation for CLBS14-RfA for the treatment of refractory
angina to define remaining steps to registration.
“We are pleased with the advancement of our clinical programs
during the third quarter. We maintain our previous guidance
regarding development milestones and continue to demonstrate
efficient management of cash spend,” stated Dr. David J. Mazzo,
President and CEO. “The fully-enrolled T-Rex Study of CLBS03 in
type 1 diabetes remains on track for top-line data in early 2019.
Our programs studying our CD34 cell therapy platform for CMD here
in the United States and CLI in Japan continue to enroll with a
target for top-line data in the second half of 2019 and early 2020,
respectively.
“We are also pleased to announce that we recently completed our
Type B meeting with the FDA pertaining to CLBS14-RfA for the
treatment of refractory angina. This meeting was conducted to
obtain FDA guidance and to define the remaining requirements for
registration of this product under the terms of its RMAT
designation. We believe that the meeting was both collaborative and
positive and our assessment of the conversation is that FDA is
demonstrating maximum flexibility afforded under the RMAT
designation as we work together to establish the development steps
necessary to bring this product to registration. We will be working
with FDA to finalize the next development steps and to formalize
the minutes of the meeting. We look forward to providing further
information once these actions are completed.”
Third Quarter Financial Highlights
Research and development expenses for the third quarter of 2018
were $1.7 million, a 47% decrease compared with $3.2 million for
the third quarter of 2017. The current quarter expenses were
principally comprised of costs in our ischemic repair programs for
CLBS12 and CLBS14-CMD, as well as initial planning for our
CLBS14-RfA program. Conversely, the prior year quarter expenses
were primarily focused on our T-Rex study for CLBS03, which
completed enrollment in December 2017 and is now in the follow-up
phase of the study.
General and administrative expenses for the third quarter of
2018 were $2.1 million, a 30% decrease compared with $2.9 million
for the third quarter of 2017, due to lower general and
administrative headcount and corporate-related activities compared
with the prior year period.
The net loss from continuing operations for the third quarter of
2018 was $3.5 million, or $0.36 per share, compared with $3.5
million, or $0.38 per share, for the third quarter of 2017.
Nine Month Financial Highlights
Research and development expenses for the nine months ended
September 30, 2018 were $6.1 million, a 46% decrease compared with
$11.2 million for the nine months of 2017. The current year
expenses were principally comprised of costs in our ischemic repair
programs for CLBS12 and CLBS14-CMD as well as initial planning for
our CLBS14-RfA program. Conversely, the prior year expenses were
primarily focused on our T-Rex study for CLBS03, which completed
enrollment in December 2017 and is now in the follow-up phase of
the study.
General and administrative expenses for the nine months ended
September 30, 2018 were $7.1 million, a 22% decrease compared with
$9.1 million for the nine months of 2017. The decrease was due to
lower general and administrative headcount and corporate-related
activities compared with the prior year period, along with the sale
of our counter-flow centrifugation system to Hitachi in the second
quarter of 2018, which resulted in a one-time $1.4 million gain
included in general and administrative expenses.
The net loss from continuing operations for the nine months
ended September 30, 2018 was $12.6 million, or $1.31 per share,
compared with $25.8 million, or $1.37 per share, for the nine
months of 2017.
Balance Sheet Highlights
As of September 30, 2018, Caladrius had cash, cash equivalents
and marketable securities of $46.1 million, compared with $60.1
million as of December 31, 2017. Based on existing programs and
projections, the Company continues to remain confident that its
cash balances and additional grant funding, along with continued
disciplined expense management, will allow it to fund its current
business plan beyond 2019.
Conference Call
Caladrius management will host a conference call for the
investment community today beginning at 4:30 p.m. Eastern time to
review financial results, provide a Company update and answer
questions.
Stockholders and other interested parties may participate in the
conference call by dialing (866) 595-8403 (domestic), or (706)
758-9979 (international), and providing conference ID: 9490459. The
call will also be broadcast live on the Internet via the Company’s
website at www.caladrius.com/investors/news-events.
For those unable to participate on the live conference call, a
replay will be available through November 15, 2018, and can be
accessed by dialing (855) 859-2056 or (404) 537-3406. All listeners
should provide the following replay access code: 9490459.
The webcast replay will be archived on the Company’s website for
90 days at www.caladrius.com.
About Caladrius Biosciences
Caladrius is a late-stage therapeutics development
biopharmaceutical company committed to the development of
innovative products that have the potential to restore the health
of people with chronic illnesses. 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. The
Company’s goal is to build a broad portfolio of novel and versatile
products that address important unmet medical needs. Our current
product candidates include three developmental treatments for
cardiovascular diseases based on our CD34 cell therapy platform:
CLBS12, recipient of SAKIGAKE designation, in Phase 2 testing in
Japan and eligible for early conditional approval for the treatment
of critical limb ischemia; CLBS14-CMD, in Phase 2 testing for the
treatment of coronary microvascular dysfunction and CLBS14-RfA in
late-stage development for refractory angina for which it has
received RMAT designation. Caladrius’ autoimmune product candidate
in Phase 2 testing, CLBS03, is an ex vivo expanded
polyclonal T regulatory cell therapy for the treatment of
recent-onset type 1 diabetes. CLBS03 has been awarded Fast Track
and Orphan designations by the FDA. 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. The Company’s actual results could
differ materially from those anticipated in these forward-looking
statements as a result of various factors. 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
22, 2018, as subsequently amended on April 2, 2018, 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.
Contacts:
Caladrius Biosciences, Inc.John MendittoExecutive Director,
Investor Relations and Corporate CommunicationsPhone:
+1-908-842-0084Email: jmenditto@caladrius.com
- Tables to Follow -
|
|
Caladrius Biosciences, Inc. |
Selected Financial Data
(unaudited) |
(in thousands, except per share
data) |
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
(in thousands, except per share data) |
2018 |
|
2017 |
2018 |
|
2017 |
Statement of Operations Data: |
|
|
|
|
|
|
Research and
development |
|
1,701 |
|
|
|
3,187 |
|
|
6,086 |
|
|
|
11,191 |
|
General and administrative |
|
2,062 |
|
|
|
2,943 |
|
|
7,105 |
|
|
|
9,082 |
|
Total operating expenses |
|
3,763 |
|
|
|
6,130 |
|
|
13,191 |
|
|
|
20,273 |
|
Operating loss |
|
(3,763 |
) |
|
|
(6,130 |
) |
|
(13,191 |
) |
|
|
(20,273 |
) |
Other income (expense), net |
|
214 |
|
|
|
177 |
|
|
585 |
|
|
|
137 |
|
Interest expense |
|
- |
|
|
|
(9 |
) |
|
(5 |
) |
|
|
(372 |
) |
Loss before income taxes and noncontrolling
interests |
|
(3,549 |
) |
|
|
(5,962 |
) |
|
(12,611 |
) |
|
|
(20,508 |
) |
Benefit from income taxes |
|
- |
|
|
|
(2,414 |
) |
|
- |
|
|
|
(8,301 |
) |
Net loss from continuing operations |
|
(3,549 |
) |
|
|
(3,548 |
) |
|
(12,611 |
) |
|
|
(12,206 |
) |
Discontinued operations |
|
- |
|
|
|
- |
|
|
- |
|
|
|
37,330 |
|
Net (loss) income |
|
(3,549 |
) |
|
|
(3,548 |
) |
|
(12,611 |
) |
|
|
25,124 |
|
Less - net income (loss) from continuing operations attributable to
noncontrolling interests |
|
1 |
|
|
|
(119 |
) |
|
(2 |
) |
|
|
(150 |
) |
Less - net loss from discontinued operations attributable to
noncontrolling interests |
|
- |
|
|
|
- |
|
|
- |
|
|
|
(568 |
) |
Net (loss) income attributable to Caladrius Biosciences,
Inc. common stockholders |
$ |
(3,550 |
) |
|
$ |
(3,429 |
) |
$ |
(12,609 |
) |
|
$ |
25,842 |
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common stockholders |
|
|
|
|
|
|
Continuing operations |
$ |
(0.36 |
) |
|
$ |
(0.38 |
) |
$ |
(1.31 |
) |
|
$ |
(1.37 |
) |
Discontinued operations |
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
|
$ |
4.30 |
|
Caladrius Biosciences, Inc. common
stockholders |
$ |
(0.36 |
) |
|
$ |
(0.38 |
) |
$ |
(1.31 |
) |
|
$ |
2.94 |
|
Weighted average common shares outstanding |
|
9,745 |
|
|
|
9,094 |
|
|
9,634 |
|
|
|
8,804 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,2018 |
|
December 31,2017 |
Balance Sheet Data: |
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
$ |
46,150 |
|
|
$ |
60,085 |
|
Total assets |
|
|
|
|
47,854 |
|
|
|
63,376 |
|
Total liabilities |
|
|
|
|
7,044 |
|
|
|
13,186 |
|
Total equity |
|
|
|
|
40,809 |
|
|
|
50,190 |
|
|
|
|
|
|
|
|
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