Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a clinical-stage biopharmaceutical company dedicated to
the development of cellular therapies designed to reverse disease,
provides a corporate update and reports financial results for the
three and twelve months ended December 31, 2020.
“Despite the continued headwinds of the global pandemic, we are
pleased to report continued progress of our development programs as
well as an improved financial situation during the fourth quarter
and full year of 2020, which reflect the resiliency, creativity and
strength of our team and the growing optimism associated with our
CD34+ cell technology-based clinical programs,” stated David J.
Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.
“We ended 2020 in a strong financial and strategic position and
have set the stage for key clinical enrollment milestones this
year.
“Importantly, we have continued the operational momentum into
2021 with an even further strengthened balance sheet, giving us the
confidence and means to expand program development and execute on
our business priorities,” Dr. Mazzo concluded.
Product Development and Financing
Highlights
CLBS16 for the treatment of coronary microvascular
dysfunction
Caladrius reported in May 2020 the compelling positive results
of its ESCaPE-CMD Phase 2a study of CLBS16 for the treatment of
coronary microvascular dysfunction (“CMD”), a disease that
continues to be underdiagnosed and potentially afflicts millions
annually - a vast majority of whom are female - with no current
treatment options. The Company is committed to raising awareness of
this growing women’s health crisis and finding an effective
treatment for it. Consequently, Caladrius recently initiated a
rigorous 105-subject Phase 2b clinical trial (the FREEDOM trial),
which, to our knowledge, is the first controlled regenerative
medicine trial in CMD, and, which is currently recruiting and
treating patients and is targeted to complete enrollment by the end
of 2021 with top line data anticipated for the third quarter of
2022. This double-blind, randomized, placebo-controlled Phase 2b
trial will evaluate the efficacy and safety of delivering
autologous CD34+ cells in subjects with CMD and without obstructive
coronary artery disease. In support of the FREEDOM trial, the
Company is engaging with the American Heart Association for a
variety of initiatives around Heart Health Month (February) and the
“Go Red for Women” campaign to help raise awareness of CMD.
HONEDRA® (CLBS12) for the treatment of critical limb
ischemia
The Company's open-label, registration-eligible study of
SAKIGAKE-designated HONEDRA® in Japan for the treatment of critical
limb ischemia (“CLI”) and Buerger’s Disease (an orphan-sized subset
of CLI) has shown strong results to date. The initial responses
observed in the subjects who have reached an endpoint in this study
are consistent with a therapeutic effect and safety profile
reported by previously published clinical trials in Japan and the
USA. Although the study's enrollment has been slowed by the
pandemic's impact in Japan, the Company is encouraged by the
patient pre-screening pipeline and hopes to conclude trial
enrollment during the second quarter of 2021. While the final
outcome of the trial will depend on all data from all subjects, the
data to date is very encouraging (~60% of subjects in the completed
Buerger’s Disease cohort have reached a positive “CLI-free”
endpoint, despite a natural history of such patients predicting
continuing disease progression to amputation).
CLBS201 for the treatment of pre-dialysis chronic kidney
disease
Our most recently proposed development program, CLBS201, is
designed to assess the safety and efficacy of CD34+ cell therapy as
a treatment for chronic kidney disease (“CKD”) in patients not yet
requiring dialysis. Based on a wealth of published preclinical and
early clinical data, it appears that the innate ability of CD34+
cells to promote the growth of new microvasculature could be a
means to attenuate the progression of the disease or even reverse
the course of CKD. Caladrius plans to file an IND for this program
in the second quarter of 2021 and to initiate a Phase 1/2
proof-of-concept study of CLBS201 in a moderate to severe CKD
population shortly thereafter. Chronic Kidney Disease remains
a largely unmet medical need, especially as the general population
ages and the incidence of diabetes and hypertension increases.
OLOGO™ for the
treatment of no option refractory disabling angina
(“NORDA”)
We acquired the rights to data and regulatory
filings for a CD34+ cell therapy program for NORDA that had been
advanced to Phase 3 by a previous sponsor. Based on the clinical
evidence from the completed studies that a single administration of
OLOGO™ reduces mortality, improves angina and increases
exercise capacity in patients with otherwise untreatable angina,
this product received Regenerative Medicine Advanced Therapy
(“RMAT”) designation from the FDA. We remain in discussion with the
FDA regarding the size and scope of a phase 3 trial which, in
combination with previously filed Phase 1, 2 and 3 data, will be
considered for the registration of OLOGO™. Notably, the RMAT
designation affords the product a 6-month review time for a
biologics license application ("BLA"), once submitted.
Closed on an additional $90.0 million in
funding
In January 2021, the Company announced that it had closed on a
$25.0 million capital raise through the sale of its common stock to
several institutional and accredited investors in a private
placement priced at-the-market under Nasdaq rules. In February
2021, the Company announced that it closed a $65.0 million capital
raise through the sale of its common stock to several institutional
and accredited investors in two registered direct offerings priced
at-the-market under Nasdaq rules.
Fourth Quarter and Full Year 2020 Financial
Highlights
Research and development expenses for the fourth quarter of 2020
were $2.9 million, a 5% increase compared with $2.8 million for the
fourth quarter of 2019, and $9.3 million for the year ended
December 31, 2020 compared to $10.8 million for the year ended
December 31, 2019, representing a decrease of approximately 14%.
Research and development in both the current year and prior year
periods focused on the advancement of our ischemic repair platform
and related to:
- Expenses associated with exploration of our concept program,
CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung
damage targeting patients with severe SARS-CoV-2 infection that
required ventilatory support due to respiratory failure (this
program has since been indefinitely postponed due to the continuous
evolution of the targeted patient population);
- Ongoing expenses for HONEDRA® in critical limb ischemia in
Japan, whereby we continue to focus spending on patient enrollment
and Japanese NDA preparation (enrollment completion is now targeted
for 2Q21 based on the impact of the COVID-19 pandemic in
Japan);
- Expenses associated with the
proof-of-concept study for CLBS16 in coronary microvascular
dysfunction, for which study enrollment was completed in the second
quarter of 2019 and full results reported in May 2020 and
continuing efforts to advance CLBS16 into a Phase 2b study (the
FREEDOM trial) in the second half of 2020; and
- Expenses associated with the ongoing dialogue with FDA
regarding design and execution of confirmatory Phase 3 study of
OLOGO™ in NORDA.
General and administrative expenses, which focus on general
corporate related activities, were $2.5 million for the three
months ended December 31, 2020, compared to $2.3 million for the
three months ended December 31, 2019, and $9.9 million for the year
ended December 31, 2020, compared to $9.3 million for the year
ended December 31, 2019, representing an increase of 6%.
Overall, net losses were $8.1 million and $19.4 million for the
years ended December 31, 2020 and 2019, respectively.
Balance Sheet Highlights
As of December 31, 2020, Caladrius had cash, cash equivalents
and marketable securities of $34.6 million and, following the
previously mentioned capital raises in January and February 2021,
the Company has cash, cash equivalents and marketable securities of
approximately $116 million as of February 25, 2021. Based on
existing programs and projections, the Company remains confident
that its current cash balances will fund its operations for the
next several years, notably, through study completion for the Phase
2b for CLBS16, through the registration-eligible study completion
for HONEDRA® and through the Phase 1/2 Proof-of-Concept study for
CLBS201 while still providing capital to explore additional
pipeline expansion opportunities.
Conference Call
Caladrius will hold a conference call on Thursday, February 25,
2021, at 4:30 p.m. Eastern time to discuss the financial results,
provide a business update and answer questions. To join the
conference call, please refer to the dial-in information provided
below. The conference call will also be webcast live under the
Investors section on the Company's website at
www.caladrius.com.
Dial-in information: U.S. Toll-Free:
866-595-8403International:
706-758-9979Conference ID / Passcode: 7372695
Please dial-in at least 10 minutes before the conference call
starts.
For those unable to participate in the live conference call, an
audio replay will be available approximately two hours after the
call has concluded until March 4, 2021, by dialing 855-859-2056
(domestic) or 404-537-3406 (international) and referencing
conference ID / passcode: 7372695. A webcast recording 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 disease. We are developing
first-in-class cell therapy products based on the finely tuned
mechanisms for self-repair that exist in the human body. 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: CLBS16, the
subject of both a recently completed positive Phase 2a study and a
newly initiated Phase 2b study in the U.S. for the treatment of
coronary microvascular dysfunction (“CMD”); HONEDRA® (CLBS12),
recipient of SAKIGAKE designation and eligible for early
conditional approval in Japan for the treatment of critical limb
ischemia (“CLI”) and Buerger’s Disease based on the results of an
ongoing clinical trial; CLBS201, designed to assess the safety and
efficacy of CD34+ cell therapy as a treatment for chronic kidney
disease (“CKD”) and OLOGO™ (CLBS14), a Regenerative Medicine
Advanced Therapy (“RMAT”) designated therapy for which the Company
is in discussion with the U.S. Food and Drug Administration (the
“FDA”) to finalize a Phase 3 protocol of reduced size and scope for
a confirmatory trial in subjects with no-option refractory
disabling angina (“NORDA”). 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 the completion of the private placement, the
satisfaction of customary closing conditions related to the private
placement and the intended use of net proceeds from the private
placement 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; market and other conditions; 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 MendittoVice
President, Investor Relations and Corporate
CommunicationsPhone: +1-908-842-0084Email: jmenditto@caladrius.com
Media: W2O GroupChristiana PascalePhone: +1-212-257-6722Email:
cpascale@w2ogroup.com
- Tables to Follow -
Caladrius Biosciences, Inc. |
Selected Financial Data |
(in thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended Dec 31, |
|
Twelve Months Ended Dec 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
(in thousands, except per share data) |
|
(unaudited) |
|
(unaudited) |
|
|
|
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,907 |
|
|
$ |
2,767 |
|
|
$ |
9,253 |
|
|
$ |
10,797 |
|
General and administrative |
|
|
2,539 |
|
|
|
2,316 |
|
|
|
9,892 |
|
|
|
9,295 |
|
Total operating expenses |
|
|
5,446 |
|
|
|
5,083 |
|
|
|
19,145 |
|
|
|
20,092 |
|
Operating loss |
|
|
(5,446 |
) |
|
|
(5,083 |
) |
|
|
(19,145 |
) |
|
|
(20,092 |
) |
Investment income, net |
|
|
15 |
|
|
|
129 |
|
|
|
132 |
|
|
|
740 |
|
Net loss before benefit from income taxes and
noncontrolling interests |
|
|
(5,431 |
) |
|
|
(4,954 |
) |
|
|
(19,013 |
) |
|
|
(19,352 |
) |
Benefit from income taxes |
|
|
- |
|
|
|
- |
|
|
|
(10,872 |
) |
|
|
- |
|
Net loss |
|
|
(5,431 |
) |
|
|
(4,954 |
) |
|
|
(8,141 |
) |
|
|
(19,352 |
) |
Less - net (loss) income attributable to noncontrolling
interests |
|
|
(1 |
) |
|
|
3 |
|
|
|
9 |
|
|
|
9 |
|
Net loss attributable to Caladrius Biosciences, Inc. common
shareholders |
|
$ |
(5,430 |
) |
|
$ |
(4,957 |
) |
|
$ |
(8,150 |
) |
|
$ |
(19,361 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common shareholders |
|
$ |
(0.28 |
) |
|
$ |
(0.47 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.88 |
) |
Weighted average common shares outstanding |
|
|
19,396 |
|
|
|
10,460 |
|
|
|
15,440 |
|
|
|
10,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,2020 |
|
December 31,2019 |
|
|
|
|
|
|
|
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
|
$ |
34,573 |
|
|
$ |
25,157 |
|
Total assets |
|
|
|
|
|
|
36,002 |
|
|
|
27,153 |
|
Total liabilities |
|
|
|
|
|
|
3,760 |
|
|
|
6,600 |
|
Total equity |
|
|
|
|
|
|
32,242 |
|
|
|
20,553 |
|
Caladrius Biosciences (NASDAQ:CLBS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Caladrius Biosciences (NASDAQ:CLBS)
Historical Stock Chart
From Apr 2023 to Apr 2024