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 six months ended June 30, 2021.
“The second quarter and first six months of 2021 have proven to
be operationally and financially positive for Caladrius. Despite
the continuing challenges presented by the COVID-19 pandemic, we
continued to advance and expand our clinical pipeline while also
adding a large amount of additional capital to our balance sheet,”
stated David J. Mazzo, Ph.D., President and Chief Executive Officer
of Caladrius. “Most notably, we are seeing steady progress with
site activation for our Phase 2b FREEDOM Trial of CLBS16 for the
treatment of coronary microvascular dysfunction, as we continue to
increase outreach activities to potential subjects in order to
accelerate enrollment. In addition, a Phase 2 proof-of-concept
clinical trial of CLBS201, designed to assess the safety and
efficacy of CD34+ cell therapy as a treatment for patients with
pre-dialysis diabetic kidney disease, is on track for a planned
initiation in the second half of 2021. Lastly, even though our
registration-eligible study of HONEDRA® in critical limb ischemia
and Buerger’s disease continues to be greatly impacted by the
Japanese government-issued states of emergency tied to the COVID-19
pandemic, we have managed to treat patients and remain optimistic
that the few remaining patients needed to complete enrollment will
be treated by year end.”
Product Development and Financing
Highlights
CLBS16 for the treatment of coronary microvascular
dysfunction
Caladrius reported in May 2020 the compelling 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. To this
end, we have partnered with the American Heart Association on a
number of activities designed to educate people about CMD and to
encourage them to discuss the condition with their physician.
Caladrius recently initiated, and is currently treating patients
in, a rigorous 105-subject Phase 2b clinical trial (the FREEDOM
Trial) which, to our knowledge, is the first controlled
regenerative medicine trial in CMD.
Investigator and subject response to the FREEDOM Trial has been
favorable and early enrollment proceeded according to plan.
However, the continued impact of the COVID-19 pandemic, including
the resurgence of cases occurring in select areas throughout the
United States, has contributed to a general slowing of enrollment.
In addition, further work with investigators and prospective
subject feedback led the Company to propose to the FDA amendments
to the FREEDOM Trial protocol to enhance the breadth and speed of
subject enrollment. These changes included expanding the techniques
that are acceptable for diagnosing CMD. Nevertheless, given the
uncertainty that persists surrounding the future impact of the
COVID-19 pandemic on potential patient recruitment and the
accessibility of investigator sites, the Company now projects
enrollment completion for the FREEDOM Trial to occur in the third
quarter of 2022 with final data (based on the 6 month assessment of
all subjects) expected by the second quarter of 2023.
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 positive therapeutic effect and safety
profile reported by previously published clinical trials in Japan
and the U.S. The study's enrollment continues to be almost stopped
by the pandemic's impact in Japan, however, the Company is
encouraged that less than a handful of patients are needed to reach
study completion, the exact date of which is impossible to predict
given the continuing impact of COVID-19 on clinical trials in
Japan. While the final outcome of the trial will depend on all data
from all subjects, the data to date is 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 that predicts continuing disease progression to
amputation). In the U.S., the Company was pleased to report that
the U.S. Food and Drug Administration (“FDA”) granted orphan
designation to CLBS12 as a treatment for Buerger’s disease,
however, any decisions regarding potential development in the U.S.
will be made after further discussion with FDA on the requirements
for registration.
CLBS201 for the treatment of diabetic kidney
disease
The Company has prepared an initial development plan for the
clinical study of CLBS201, a CD34+ investigational product for
administration via the renal arteries to slow the deterioration,
or, ideally, reverse the decline of renal function in patients with
diabetic kidney disease ("DKD") who, although still pre-dialysis,
exhibit rapidly progressing stage 3b disease. Progressive kidney
failure is associated with attrition of the microcirculation of the
kidney. Pre-clinical studies in kidney disease and injury models
have demonstrated that protection or replenishment of the
microcirculation results in improved kidney function. A Phase 2
proof of concept, randomized, placebo-controlled study for the
stage 3b chronic kidney disease patient population is planned to
initiate in the second half of 2021. The protocol, pending final
central institutional review board approval, calls for a
six-subject open-label treatment run-in arm in which patients will
be treated sequentially, to be completed, evaluated and cleared for
continuation by the study’s data safety monitoring board prior to
initiating the 40-patient randomized, placebo-controlled, double
blinded portion of the trial. The Company is projecting that safety
data from the six-subject run-in arm will be completed by the end
of the second quarter of 2022.
OLOGO™ for the
treatment of no option refractory disabling angina
Caladrius acquired the rights to data and
regulatory filings for a CD34+ cell therapy program for no option
refractory disabling angina (“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. Discussions with the FDA have resulted in
a rejection of the Company's efforts to reduce the FDA requirement
of a 400-patient Phase 3 study for registration (including an arm
of 50 standard of care patients and an arm of 150 placebo
patients), despite data showing that the NORDA population is orphan
in size. Because enrollment of a study of this magnitude and design
is projected to take many years, if executable at all, the Company
has decided not to pursue a Phase 3 program for OLOGO™ on its own,
but will continue to seek a partner to execute the study and
advance the program.
Sufficient capital to fund operations
beyond multiple key data readouts anticipated in 2023
As previously disclosed, in January 2021, Caladrius raised $25.0
million 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
and warrants to several institutional and accredited investors in
two registered direct offerings priced at-the-market under Nasdaq
rules. In addition, in May 2021, the Company received $1.4 million
in non-dilutive funding as an approved participant of the
Technology Business Tax Certificate Transfer Program (the
“Program”) sponsored by the New Jersey Economic Development
Authority (NJEDA). The Program enables qualifying New Jersey-based
biotechnology or technology companies to sell a percentage of their
New Jersey net operating losses (“NOLs”) and research and
development tax credits to unrelated qualifying corporations.
Second Quarter 2021 Financial Summary
Research and development expenses were approximately $4.3
million for the three months ended June 30, 2021, compared to $1.8
million for the three months ended June 30, 2020, representing an
increase of 138%. Research and development in both periods focused
on the advancement of our ischemic repair platform and related
to:
- Expenses associated with efforts to advance the FREEDOM Trial
where the first patient was dosed in the first quarter of
2021;
- Expenses associated with the planning and preparation of an IND
and Phase 2 proof-of-concept protocol for CLBS201 as a treatment
for diabetic kidney disease; and
- Ongoing expenses for HONEDRA® in critical limb ischemia and
Buerger’s disease in Japan for which we continue to focus spending
on patient enrollment and Japanese NDA preparation.
General and administrative expenses were approximately $2.8
million for the three months ended June 30, 2021, compared to $2.5
million for the three months ended June 30, 2020, representing an
increase of 14%.
Overall, net losses were $5.7 million for the three months
ended June 30, 2021, compared to net income of
$6.6 million for the three months ended June 30,
2020.
Balance Sheet Highlights
As of June 30, 2021, we had cash,
cash equivalents and marketable securities of approximately $106.1
million. 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 FREEDOM Trial, through the registration-eligible
study completion for HONEDRA® and through the Phase 2
proof-of-concept study for CLBS201, while still potentially
providing capital to explore additional pipeline expansion
opportunities.
Conference
Call
Caladrius will hold a live conference call today, August 5, 2021,
at 4:30 p.m. (ET) to discuss financial results, provide a business
update and answer questions. To join the conference call, please
refer to the dial-in information provided below. A live webcast of
the call will also be available under the Investors & News
section of the Caladrius website, https://ir.caladrius.com, and
will be available for replay for 90 days after the conclusion of
the call.
Dial-in information: U.S. Toll-Free:
844-369-8774International: 862-298-0844
Please dial-in 10 minutes before the conference call starts.
For those unable to participate on the live conference call, an
audio replay will be available that day starting at 7:30 p.m. (ET)
until August 19, 2021, by dialing 877-481-4010 (U.S. Toll-Free) or
919-882-2331 (International) and by entering the replay passcode:
42180.
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 (www.freedom-trial.com) in the U.S.
for the treatment of coronary microvascular dysfunction (“CMD”);
CLBS12 (HONEDRA® in Japan), recipient of orphan designation
for Buerger’s Disease in the U.S. and, in Japan, recipient of a
SAKIGAKE designation and eligible for early conditional approval
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 diabetic kidney disease (“DKD”); and OLOGO™
(CLBS14), a Regenerative Medicine Advanced Therapy (“RMAT”)
designated phase 3 ready therapy for 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, 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
February 25, 2021 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: 908-842-0084Email: jmenditto@caladrius.com
Media: Rachel GirardReal ChemistryPhone: 401-477-4030Email:
rgirard@realchemistry.com
- Tables to Follow –
Caladrius
Biosciences, Inc. |
|
Selected
Financial Data |
|
(in
thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended Jun 30, |
|
Six Months Ended Jun 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
(in thousands, except per share data) |
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
Research and development |
$ |
4,329 |
|
|
$ |
1,818 |
|
|
$ |
9,405 |
|
|
$ |
3,317 |
|
|
General and administrative |
|
2,818 |
|
|
|
2,474 |
|
|
|
5,828 |
|
|
|
5,032 |
|
|
Total operating expenses |
|
7,147 |
|
|
|
4,292 |
|
|
|
15,233 |
|
|
|
8,349 |
|
|
Operating loss |
|
(7,147 |
) |
|
|
(4,292 |
) |
|
|
(15,233 |
) |
|
|
(8,349 |
) |
|
Investment income, net |
|
47 |
|
|
|
22 |
|
|
|
70 |
|
|
|
93 |
|
|
Other expense, net |
|
(90 |
) |
|
|
- |
|
|
|
(90 |
) |
|
|
- |
|
|
Net loss before benefit from income taxes and
noncontrolling interests |
|
(7,190 |
) |
|
|
(4,270 |
) |
|
|
(15,253 |
) |
|
|
(8,256 |
) |
|
Benefit from income taxes |
|
(1,508 |
) |
|
|
(10,872 |
) |
|
|
(1,508 |
) |
|
|
(10,872 |
) |
|
Net (loss) income |
|
(5,682 |
) |
|
|
6,602 |
|
|
|
(13,745 |
) |
|
|
2,616 |
|
|
Less - net income attributable to noncontrolling interests |
|
- |
|
|
|
4 |
|
|
|
- |
|
|
|
8 |
|
|
Net (loss) income attributable to Caladrius Biosciences,
Inc. common stockholders |
$ |
(5,682 |
) |
|
$ |
6,598 |
|
|
$ |
(13,745 |
) |
|
$ |
2,608 |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted (loss) income per share attributable to
Caladrius Biosciences, Inc. common stockholders |
$ |
(0.10 |
) |
|
$ |
0.50 |
|
|
$ |
(0.27 |
) |
|
$ |
0.22 |
|
|
Weighted average common shares outstanding |
|
59,510 |
|
|
|
13,151 |
|
|
|
50,862 |
|
|
|
11,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
(unaudited) |
|
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
$ |
106,090 |
|
|
$ |
34,573 |
|
|
Total assets |
|
|
|
|
|
108,614 |
|
|
|
36,002 |
|
|
Total liabilities |
|
|
|
|
|
3,935 |
|
|
|
3,760 |
|
|
Total equity |
|
|
|
|
|
104,679 |
|
|
|
32,242 |
|
|
|
|
|
|
|
|
|
|
|
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