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 months ended March 31, 2021.
“We are at a truly exciting point in our evolution with
tremendous opportunities ahead of us. While the pandemic has
impacted many companies, during the first quarter of 2021 we were
able to both markedly strengthen our financial position and advance
and expand our clinical pipeline,” stated David J. Mazzo, Ph.D.,
President and Chief Executive Officer of Caladrius. To date, we are
seeing good progress with site activation for our Phase 2b clinical
trial of CLBS16 in the U.S., known as the FREEDOM Trial, for the
treatment of coronary microvascular dysfunction as we continue to
accelerate enrollment. Additionally, we remain optimistic that we
soon will complete enrollment in our registration-eligible study of
HONEDRA® in critical limb ischemia and Buerger’s disease in Japan.
However, enrollment for this program has been greatly impacted by
the Japanese government-issued states of emergency tied to the
pandemic. Lastly, we are working with the U.S. Food and Drug
Administration (“FDA”) to finalize the protocol design for our
CLBS201 proof-of-concept study in diabetic kidney disease and have
targeted initiation of that Phase 2 study in the third quarter of
2021.”
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. 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. The trial 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 to the
hearts of subjects with 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
U.S. The study's enrollment continues to be slowed by the
pandemic's impact in Japan, however, the Company is encouraged by
the patient pre-screening pipeline and continues to make progress
towards 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 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 that predicts continuing disease progression to
amputation). In the U.S., the Company was pleased to report that
the FDA granted orphan designation to CLBS12 as a treatment for
Buerger’s disease.
CLBS201 for the treatment of diabetic kidney
disease
The Company’s most recently proposed development program,
CLBS201, is designed to assess the safety and efficacy of CD34+
cell therapy as a treatment for diabetic kidney disease 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 diabetic kidney
disease. A Phase 2 proof of concept, randomized,
placebo-controlled study is planned for initiation in the second
half of 2021.
OLOGOTM
for the treatment of no option refractory disabling angina
(“NORDA”)
Caladrius 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 OLOGOTM 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. Caladrius remains in
ongoing discussions with the FDA regarding the size and scope of an
appropriate and practical Phase 3 trial, which in combination with
previously filed Phase 1, 2 and 3 data, will be considered for the
registration of OLOGOTM. Notably, the RMAT designation affords the
product a 6-month review time for a biologics license application
("BLA"), once submitted.
Sufficient capital to fund operations beyond multiple
key data readouts (>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 to
several institutional and accredited investors in two registered
direct offerings priced at-the-market under Nasdaq rules.
First Quarter 2021 Financial Summary
Research and development expenses for the three months ended
March 31, 2021 were $5.1 million, compared to $1.5 million for the
three months ended March 31, 2020. Research and development in the
current year period focused on the advancement of our ischemic
repair platform and related to:
- 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; and
- Expenses associated with efforts to
advance the FREEDOM Trial where the first patient was dosed in the
first quarter of 2021; and
- Expenses associated with the planning and preparation of an IND
and proof-of-concept protocol for CLBS201 as a treatment for
diabetic kidney disease.
General and administrative expenses, which focus on general
corporate related activities, were $3.0 million for the three
months ended March 31, 2021 compared to $2.6 million for the three
months ended March 31, 2020, representing an increase of 18%.
Overall, net losses were $8.1 million and $4.0 million for the
years ended March 31, 2021 and 2020, respectively.
Balance Sheet Highlights
As of March 31, 2021, Caladrius had cash, cash equivalents and
marketable securities of approximately $111.5 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 providing capital to explore additional
pipeline expansion opportunities.
Conference
Call
Caladrius will hold a live conference call today, May 6, 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 “Events” in the Investors
section of the Caladrius website,
https://www.caladrius.com/investors, and will be available for
replay for 90 days after the conclusion of the call.
Dial-in information: U.S. Toll-Free:
866-595-8403International:
706-758-9979Conference ID / Access code:
6892792
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 May 13, 2021, by dialing 855-859-2056 (North America) or
404-537-3406 (International) and by entering the access code:
6892792.
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 orphan designation for Buerger’s disease in the U.S.
as well as 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 diabetic kidney disease;
and OLOGO™ (CLBS14), a Regenerative Medicine Advanced Therapy
(“RMAT”) designated therapy for which the Company is in discussion
with the FDA to finalize a Phase 3 protocol of appropriate and
practical 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
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: +1-908-842-0084Email: jmenditto@caladrius.com
Media: Real ChemistryKelly WakeleePhone: 610.639.2774Email:
kwakelee@realchemistry.com
Caladrius
Biosciences, Inc. |
|
Selected
Financial Data |
|
(in
thousands, except per share data) |
|
|
|
|
|
|
|
|
|
Three Months Ended Mar 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
(in thousands, except per share data) |
|
(unaudited) |
|
(unaudited) |
|
Statement of Operations Data: |
|
|
|
|
|
Research and development |
|
$ |
5,076 |
|
|
$ |
1,499 |
|
|
General and administrative |
|
|
3,010 |
|
|
|
2,558 |
|
|
Total operating expenses |
|
|
8,086 |
|
|
|
4,057 |
|
|
Operating loss |
|
|
(8,086 |
) |
|
|
(4,057 |
) |
|
Investment income, net |
|
|
23 |
|
|
|
71 |
|
|
Net loss |
|
|
(8,063 |
) |
|
|
(3,986 |
) |
|
Less - net income attributable to noncontrolling interests |
|
|
- |
|
|
|
4 |
|
|
Net loss attributable to Caladrius Biosciences, Inc. common
stockholders |
|
$ |
(8,063 |
) |
|
$ |
(3,990 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Caladrius
Biosciences, Inc. common stockholders |
|
$ |
(0.19 |
) |
|
$ |
(0.38 |
) |
|
Weighted average common shares outstanding |
|
|
42,117 |
|
|
|
10,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
|
(unaudited) |
|
|
|
Balance Sheet Data: |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
111,511 |
|
|
$ |
34,573 |
|
|
Total assets |
|
|
114,607 |
|
|
|
36,002 |
|
|
Total liabilities |
|
|
4,593 |
|
|
|
3,760 |
|
|
Total equity |
|
|
110,014 |
|
|
|
32,242 |
|
|
|
|
|
|
|
|
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