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, disease, provides a corporate update and announces
financial results for the three months ended March 31, 2020.
Product Development and Financing
Highlights
Caladrius initiates development of CLBS119, a CD34+ cell
therapy specifically intended to repair COVID-19 induced lung
damage
For thousands of COVID-19 survivors leaving hospitals around the
world, vestiges of the virus will return home with them in the form
of debilitating lung damage. Many companies are searching for
treatments for the acute effects of the virus or for a vaccine that
thwarts infection altogether. Caladrius, however, has taken a
leadership position in helping those patients who have beaten the
virus but have suffered potentially permanent lung damage in the
battle. Initial evidence indicates that a large portion of the
survivors of COVID-19 who required ventilatory support will suffer
long-term, debilitating lung damage.1 Scientists learned in the
aftermath of the first SARS epidemic that the coronavirus targets
cells that express CD34.2 Depletion of that cell population
generally is thought to be connected to the lung’s inability to
repair itself.2 Early reports from the COVID-19 pandemic indicate
that the endothelial cells that line the microvasculature of the
lung are targeted by the virus and that the destruction of the lung
microcirculation may be a critical factor in the inability of the
lung to repair itself even after the virus has been eliminated.3
Clinical trials and preclinical models have shown that CD34+ cells
act in a restorative and regenerative capacity in multiple organs,
including models of severe lung inflammation.4 Research has also
shown that a deficiency in vascular CD34+ cells can result in a
predisposition to injury in the lungs.5 Caladrius has opened an
Investigational New Drug (“IND”) application, agreed with the Food
and Drug Administration (“FDA”) on a protocol and has begun
manufacturing preparation with the intention of initiating a
clinical trial as soon as possible to evaluate CLBS119 as a
treatment to restore lung function specifically in patients who
experienced severe SARS-CoV-2 infection and required ventilatory
support due to respiratory failure.
CLBS12 development in Japan continues to yield promising
results
The Company’s open-label, registration-eligible study of CLBS12,
its SAKIGAKE-designated product candidate, in Japan for the
treatment of critical limb ischemia (“CLI”), a disease with no
currently available approved therapy6 and a higher mortality rate
than all cancers except that of lung cancer,7 has shown positive
results to date. The Buerger’s Disease cohort has concluded with 4
out of 7 (57%) patients achieving a positive outcome. Although the
study enrollment, which had been targeted for completion this year,
has been slowed by the impact of the COVID-19 pandemic in Japan,
the Company is encouraged by the patient pre-screening pipeline
that has been identified and hopes to conclude the trial enrollment
rapidly once the coronavirus abates and physicians are again able
to treat non-COVID-19 patients. Based on the data from the
concluded Buerger’s Disease cohort and the data to date in the
no-option CLI cohort, the Company affirms its expectation of the
study’s ultimate success.
CLBS16 demonstrates ability to improve coronary flow
reserve in patients and potentially reverse coronary microvascular
dysfunction
Caladrius reported that it has concluded its ESCaPE-CMD study of
CLBS16 for the treatment of coronary microvascular dysfunction
(“CMD”), a disease that potentially afflicts millions annually with
no current treatment options. The full data from that study will be
presented at the SCAI 2020 Scientific Sessions Virtual Conference
on May 14th and is expected to corroborate the positive partial
results presented at the American Heart Association Scientific
Sessions in November 2019. The Company is already taking steps
necessary to initiate the next trial in CLBS16 development, a Phase
2b study, in the fall of 2020.
CLBS14 remains poised to enter a single confirmatory
phase 3 clinical trial pending finalization of funding
The Company’s Phase 3 protocol for its RMAT-designated product
candidate, CLBS14, for the treatment of no-option refractory angina
(“NORDA”) remains ready to initiate pending sufficient funding to
run the program to completion. Based on substantial data from
previous Phase 1, 2, and 3 studies, Caladrius remains confident in
the potential for clinical success once the program is
executed.
An additional ~$16 million of capital (~$11 million of
which is non-dilutive) added to balance sheet
Notwithstanding the challenging financial macro-environment,
Caladrius recently announced that it secured approximately $10.9
million of non-dilutive capital from the sale of its New Jersey net
operating losses (“NJ NOLs”) through the New Jersey Technology
Business Tax Certificate Transfer Program. Soon thereafter it
raised an additional $5.0 million pursuant to a registered direct
institutional offering priced at-the-market under Nasdaq rules.
This infusion of capital at this time once again demonstrates the
Company’s ability to acquire non-dilutive capital. The successful
completion of the registered direct offering during the COVID-19
pandemic also reinforces the attractiveness of the Company, its
progress and the potential of its programs to the capital markets.
The collected funds will, among other things, support the continued
advancement of its ongoing CD34+ technology-based clinical
programs.
“Throughout this extraordinary time, we remain steadfast in our
commitment to advance our CD34+ cell technology-based clinical
development programs, even as the global COVID-19 pandemic provokes
unprecedented challenges for product development,” stated David J.
Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.
“In fact, we have rallied to address the challenges of the pandemic
and responded by defining and quickly moving to development
CLBS119. We’ve done this while further securing our financial
situation at a time when other companies are being forced to take
draconian measures just to survive financially.
“Despite the global uncertainty brought about by the
coronavirus, we are excited about what lies ahead in 2020 and
expect to build on the momentum we generated during the first
quarter,” concluded Dr. Mazzo.
First Quarter 2020 Financial Highlights
Research and development expenses for the first quarter of 2020
were $1.5 million, a 26% decrease compared with $2.0 million for
the first quarter of 2019. Research and development in both periods
focused on the advancement of our ischemic repair platform. More
specifically, R&D expense was incurred as a result of our
ongoing registration-eligible study for CLBS12 in critical limb
ischemia in Japan, along with the concluding expenses for our
ESCaPE-CMD clinical study for CLBS16 in coronary microvascular
dysfunction. Note that the majority of costs associated with
the ESCaPE-CMD clinical trial were covered by a grant from the
National Institutes of Health.
General and administrative expenses, which focus on general
corporate related activities, remain constant and were
approximately $2.6 million for both the first quarters of 2020 and
2019.
The net loss for the first quarter of 2020 was $4.0 million, or
$0.38 per share, compared with $4.4 million, or $0.44 per share,
for the first quarter of 2019.
Balance Sheet Highlights
As of March 31, 2020, Caladrius had cash and cash equivalents of
$20.7 million. Together with the combined net proceeds from the
sale of the NJ NOLs and the registered direct offering in April
2020, our cash and cash equivalents today are approximately $34
million. Based on existing programs and projections, the Company
remains confident that its current cash balances will fund its
operations into the second half of 2021.
Conference Call
Caladrius management will host a conference call for investors
beginning at 4:30 p.m. ET on Thursday, May 7, 2020 to discuss the
financial results, provide a business update and answer
questions.
Shareholders and other interested parties may participate in the
conference call by dialing 866-595-8403 (domestic) or 706-758-9979
(international) and referencing conference ID number 8869677. The
conference call will also be webcast live under the Investors
section of the Company's website at www.caladrius.com.
For those unable to participate in the live conference call, a
replay will be accessible approximately two hours after its
completion through May 14, 2020, by dialing 855-859-2056 (domestic)
or 404-537-3406 (international) and referencing conference ID
number 8869677. A webcast of the call will also be archived for 90
days under the Investors section of the Company’s website at
www.caladrius.com.
About Caladrius Biosciences
Caladrius 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.
The Company's current product candidates include CLBS119, a
CD34+ cell therapy product candidate for the repair of lung damage
found in patients with severe COVID-19 infection who experienced
respiratory failure, for which the Company plans to initiate a
clinical trial in the coming months as well as three developmental
treatments for ischemic diseases based on its CD34+ cell therapy
platform: CLBS12, recipient of SAKIGAKE designation 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, the subject of a recently completed
positive Phase 2 clinical trial in the U.S. for the treatment of
coronary microvascular dysfunction ("CMD"); and CLBS14, a
Regenerative Medicine Advanced Therapy ("RMAT") designated therapy
for which the Company has finalized with the U.S. Food and Drug
Administration (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.
1Yuhui Wang, et al, Radiology, March 19, 2020
2Chen Y, Chan VS, Zheng B, et al. A novel subset of putative
stem/progenitor CD34+Oct-4+ cells is the major target for SARS
coronavirus in human lung. J Exp Med. 2007;204(11):2529‐2536.
doi:10.1084/jem.20070462
3Varga Z, Flammer AJ, Steiger P, et al. Endothelial cell
infection and endotheliitis in COVID-19. Lancet.
2020;395(10234):1417‐1418. doi:10.1016/S0140-6736(20)30937-5
4Abd-Allah, et al, Cytotherapy, 2015;17(4):443-53
5Lo, Gold, Scheer, et al.: CD34 Maintains Lung Vascular
Integrity after Injury
6Cacione DG, et al, Pharm. treatment of Buerger’s Disease,
Cochrane Database of Systematic Reviews, 2016, (3) CD011033
7Mustapha, J. A., Katzen, B. T., et al. (2019, May).
Endovascular Today, 18(5), 80-82
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 the intended use of net proceeds from the
registered direct offering and the sale of NJ NOLs as well as 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, 2020 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, except as required by law.
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
Caladrius Biosciences,
Inc. |
Selected Financial
Data |
(in thousands, except per share
data) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
(in thousands, except per share data) |
|
(unaudited) |
|
(unaudited) |
Statement of Operations Data: |
|
|
|
|
Research and development |
|
$ |
1,499 |
|
|
$ |
2,038 |
|
General and administrative |
|
|
2,558 |
|
|
|
2,554 |
|
Total operating expenses |
|
|
4,057 |
|
|
|
4,592 |
|
Operating loss |
|
|
(4,057 |
) |
|
|
(4,592 |
) |
Investment income, net |
|
|
71 |
|
|
|
227 |
|
Net loss |
|
|
(3,986 |
) |
|
|
(4,365 |
) |
Less - net income attributable to noncontrolling interests |
|
|
4 |
|
|
|
2 |
|
Net loss attributable to Caladrius Biosciences, Inc. common
stockholders |
|
$ |
(3,990 |
) |
|
$ |
(4,367 |
) |
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common stockholders |
$ |
(0.38 |
) |
|
$ |
(0.44 |
) |
Weighted average common shares outstanding |
|
|
10,623 |
|
|
|
10,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2020 |
|
December 31, 2019 |
|
|
(unaudited) |
|
|
Balance Sheet Data: |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
20,745 |
|
|
$ |
25,157 |
|
Total assets |
|
|
22,140 |
|
|
|
27,153 |
|
Total liabilities |
|
|
5,156 |
|
|
|
6,600 |
|
Total equity |
|
|
16,984 |
|
|
|
20,553 |
|
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