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 nine months ended September 30, 2019.
“I am pleased with our third quarter performance as we continued
to advance our ongoing CD34+ technology-based clinical programs for
which the data continues to trend positively. Enrollment in
Japan for the study of CLBS12 in critical limb ischemia (“CLI”) is
ongoing and we anticipate completion in the first half of 2020,
with top line data targeted for late 2020 or early in 2021.
We remain on track for an earliest possible approval in Japan
during 2021 based on the accelerated review afforded by CLBS12’s
SAKIGAKE designation. The 6-month follow-up from all subjects
in our ESCaPE-CMD study of CLBS16 in coronary microvascular
dysfunction (“CMD”) will be completed by the end of this year and
we are very excited to have the latest data from the study
presented by Dr. C. Noel Bairey Merz at the upcoming American Heart
Association Scientific Sessions 2019 on November 16th.
Assuming that the full data set corroborates previously reported
results, we are planning to advance the program to its next
clinical development step as expeditiously as possible,” stated
David J. Mazzo, Ph.D., President and Chief Executive Officer of
Caladrius.
“Lastly, we substantially completed the preparatory work for the
initiation of a confirmatory Phase 3 trial of CLBS14 in no-option
refractory disabling angina (“NORDA”); however, we will not
commence enrolling patients until sufficient capital resources are
identified that would give us confidence that the study could be
funded through completion,” Dr. Mazzo continued. “As a result, and
after eliminating CLBS14 study costs from our 2020 operating
budget, our projected cash runway will now bring us into early
2021.”
Third Quarter Financial Highlights
Research and development expenses for the third quarter of 2019
were $3.0 million, a 77% increase compared with $1.7 million for
the third 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
registration-eligible Phase 2 clinical study in Japan for CLBS12 in
CLI, (ii) expense associated with our ESCaPE-CMD 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 $2.1 million for both the third
quarters of 2019 and 2018.
The net loss for the third quarter of 2019 was $4.9 million, or
$0.47 per share, compared with $3.5 million, or $0.36 per share,
for the third quarter of 2018.
Nine Month Financial Highlights
Research and development expenses for the first nine months of
2019 were $8.0 million, a 32% increase compared with $6.1 million
for the first nine 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 clinical study in Japan for CLBS12 in CLI, (ii) expense
associated with our ESCaPE-CMD 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 $7.0 million for the first nine
months of 2019, a 2% decrease compared with $7.1 million for the
first nine months of 2018.
The net loss for the first nine months of 2019 was $14.4
million, or $1.40 per share, compared with $12.6 million, or $1.31
per share, for the first nine months of 2018.
Balance Sheet Highlights
As of September 30, 2019, Caladrius had cash, cash equivalents
and marketable securities of $29.2 million. Based on existing
programs and projections, the Company remains confident that its
cash balances will allow it to fund its current business plan until
early 2021.
Conference Call
Caladrius’ management will host a conference call for the
investment community beginning at 4:30 p.m. ET on Wednesday,
November 6, 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: 9091688.
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 November 13, 2019. To access the audio replay,
dial (855) 859-2056 (domestic) or (404) 537-3406 (international)
and provide conference ID number: 9091688.
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, a Phase 3 ready clinical program in no
option refractory disabling angina and recipient of a RMAT
designation in the U.S.A. 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 September 30, |
|
Nine Months Ended September 30, |
(in thousands, except per share data) |
2019 |
|
2018 |
|
2019 |
|
2018 |
Statement of
Operations Data: |
|
|
|
|
|
|
|
Research and development |
3,004 |
|
1,701 |
|
$ |
8,030 |
|
$ |
6,086 |
General and administrative |
2,068 |
|
2,062 |
|
6,980 |
|
7,105 |
Total operating expenses |
5,072 |
|
3,763 |
|
15,010 |
|
13,191 |
Operating
loss |
(5,072) |
|
(3,763) |
|
(15,010) |
|
(13,191) |
Investment income, net |
175 |
|
214 |
|
611 |
|
585 |
Interest expense |
- |
|
- |
|
- |
|
(5) |
Net loss |
(4,897) |
|
(3,549) |
|
(14,399) |
|
(12,611) |
Less - net income (loss) attributable to noncontrolling
interests |
1 |
|
1 |
|
6 |
|
(2) |
Net loss attributable to Caladrius Biosciences, Inc. common
stockholders |
$ |
(4,898) |
|
$ |
(3,550) |
|
$ |
(14,405) |
|
$ |
(12,609) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common stockholders |
$ |
(0.47) |
|
$ |
(0.36) |
|
$ |
(1.40) |
|
$ |
(1.31) |
Weighted average common shares outstanding |
10,411 |
|
9,745 |
|
10,279 |
|
9,634 |
|
|
|
|
|
September 30,2019 |
|
December 31,2018 |
Balance Sheet Data: |
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
$ |
29,161 |
|
$ |
43,053 |
Total assets |
|
|
|
|
31,671 |
|
44,580 |
Total liabilities |
|
|
|
|
6,689 |
|
7,126 |
Total equity |
|
|
|
|
24,982 |
|
37,454 |
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