Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the
“Company”), a clinical-stage pharmaceutical company developing
innovative therapies for the treatment of advanced solid tumors and
other serious diseases, today announced its financial results for
the three and nine months ended September 30, 2022 and provided a
business update.
"We are excited to report our first quarter as Lisata
Therapeutics following the merger of Caladrius Biosciences and Cend
Therapeutics,” stated David J. Mazzo, Ph.D., Chief Executive
Officer of Lisata. “The team has made tremendous progress over the
past few months and now, as Lisata, we are building an enduring
pharmaceutical company for the treatment of diseases with
significant unmet medical needs. As such, our primary focus is the
advancement of our clinical development pipeline of candidates
targeting oncology and ischemic disease indications. LSTA1, our
lead investigational product candidate from the CendR Platform™, is
the subject of multiple planned and ongoing clinical trials being
conducted globally in a variety of solid tumor types and in
combination with several chemotherapy and immunotherapy anti-cancer
regimens. We believe that LSTA1 has the potential to become an
integral part of a revised standard-of-care therapy for many
difficult to treat cancers. Recent guidance from the U.S. Food and
Drug Administration has given us further direction on what would be
required for registration. We have discussed this guidance with our
development partners and we are planning adjustments to protocols,
including the modification and expansion of ongoing studies.
Dr. Mazzo continued, “Overall, we’re invigorated by the promise
of our platform technologies and pipeline of product and partnering
opportunities and look forward to providing updates on our progress
in the coming months.”
Development Portfolio Update
LSTA1 as a treatment for solid tumor cancers in
combination with other anti-cancer agents
LSTA1, formerly known as CEND-1, is an investigational drug that
actuates the CendR active transport mechanism while also having the
potential to modify the tumor microenvironment (“TME”) and make is
less immunosuppressive. It is targeted to tumor vasculature by its
affinity for alpha-v, beta-3 and beta-5 integrins that are
selectively expressed in tumor vasculature, but not healthy tissue.
LSTA1 is a specific cyclic internalizing RGD (“iRGD”) peptide that,
once bound to these integrins, is cleaved by proteases expressed in
tumors to release a peptide fragment, called a CendR fragment,
which binds to a second receptor, called neuropilin-1, to activate
a novel uptake pathway that allows anticancer drugs to more
selectively penetrate solid tumors. The ability of LSTA1 and iRGD
peptides to modify the TME to enhance delivery and efficacy of
co-administered drugs has been demonstrated in models of a range of
solid tumors with the results from Lisata, collaborators and
research groups around the world having been the subject of over
200 scientific publications. Lisata and its collaborators have also
amassed significant non-clinical data demonstrating enhanced
delivery of a range of emerging anti-cancer therapies, including
immunotherapies and RNA-based therapeutics. Clinically, LSTA1 has
demonstrated favorable safety, tolerability, and activity in
clinical trials to enhance delivery of standard-of-care
chemotherapy for pancreatic cancer. Lisata is exploring the
potential of LSTA1 to enable a variety of treatment modalities to
treat a range of solid tumors more effectively. Currently, LSTA1 is
the subject of Phase 1b/2a and 2b clinical studies being conducted
globally in various solid tumors, including metastatic pancreatic
ductal adenocarcinoma, in combination with a variety of anti-cancer
regimens. The combination of LSTA1 with corresponding
standards-of-care in other solid tumor indications is planned for
clinical study in the first half of 2023.
HONEDRA® (LSTA12, aka CLBS12) for the treatment of
critical limb ischemia (“CLI”)
HONEDRA® is the Company’s SAKIGAKE-designated product candidate
for the treatment of CLI and Buerger’s disease in Japan, which is
now in the pre-consultation phase of the registration process with
the Pharmaceuticals and Medical Devices Agency (“PMDA”) in Japan.
Data from the follow-up of all patients completed in the
registration-eligible clinical trial in Japan have been compiled
and are being reviewed by the PMDA, after which the PMDA is
expected to provide important perspective to be considered in
preparation for the formal consultation meetings which precede the
Japanese new drug application. If successful in the
pre-consultation process, Lisata expects formal clinical
consultation to occur by mid-year 2023. Concomitantly, the Company
is focusing its efforts to secure a Japanese partner to complete
the remaining steps to produce registration in Japan.
XOWNA® (LSTA16, aka CLBS16) for the treatment of
coronary microvascular dysfunction (“CMD”)
XOWNA® is an experimental regenerative therapy for the treatment
of CMD. It was the subject of a positive Phase 2a study (the
“ESCaPE-CMD trial”) reported in 2020 and is currently being
evaluated in a U.S. Phase 2b study (the “FREEDOM Trial”). The
FREEDOM Trial was originally designed as a 105-patient
double-blind, randomized, placebo-controlled trial to further
evaluate the efficacy and safety of intracoronary delivery of
autologous CD34+ cells (XOWNA®) in subjects with CMD and without
obstructive coronary artery disease and was expected to complete
enrollment in approximately 12 months. As previously disclosed,
enrollment in the FREEDOM Trial initially proceeded as planned with
the first patient treated in January 2021; however, the impact of
the COVID-19 pandemic in the U.S., coupled with supply chain issues
associated with the catheters used for diagnosis of CMD and/or
administration of XOWNA®, as well as with a contrast agent
typically used in many catheter laboratories, have made and
continue to make enrollment much slower than originally predicted
and challenging to accelerate. As a result, the Company announced
that enrollment in the FREEDOM Trial had been suspended and that it
intended to conduct an interim analysis of the data from not less
than the first 20 patients enrolled using the 6-month follow-up
data to evaluate the efficacy and safety of XOWNA® in subjects with
CMD. Following the analysis of results of the FREEDOM Trial
subjects completing 6-month follow-up along with Key Opinion
Leaders’ input, the Company’s board of directors determined that
execution of a redesigned FREEDOM-like trial would be the
appropriate next step, but the cost of such a trial would be
prohibitively expensive to undergo alone and without a strategic
partner. Accordingly, the Company’s board of directors concluded
that XOWNA® development will only be continued if a strategic
partner that can contribute the necessary capital for a redesigned
trial is identified and secured.
LSTA201 (aka CLBS201) for the treatment of diabetic
kidney disease (“DKD”)
Progressive kidney failure is associated with attrition of the
microcirculation of the kidney. Preclinical studies in kidney
disease and injury models have demonstrated that protection or
replenishment of the microcirculation results in improved kidney
function. Based on these observations, the Company initiated a
Phase 1b, open-label, proof-of-concept trial evaluating LSTA201, a
CD34+ regenerative cell therapy investigational product for
intra-renal artery administration in patients with DKD. Patients
selected for the study are in the pre-dialysis stage of kidney
disease and exhibit rapidly progressing stage 3b disease. The
protocol provides for a cohort of six patients overseen by an
independent Data Safety Monitoring Board with the objective of
determining the tolerance of intra-renal cell therapy injection in
DKD patients as well as the ability of LSTA201 to regenerate kidney
function. A key read-out of data will occur at the 6-month
follow-up visit for all patients. The Company treated the first
patient in April 2022 and completed treatment for all six subjects
during the third quarter of 2022. Top-line data is anticipated from
all subjects by the first quarter of 2023.
Third Quarter 2022 Financial Highlights
Research and development expenses were approximately $3.4
million for the three months ended September 30, 2022, compared to
$4.1 million for the three months ended September 30, 2021,
representing a decrease of $0.7 million or 18.1%. This was
primarily due to a decrease in expenses associated with our XOWNA®
Phase 2b study (the FREEDOM Trial) as a result of the suspension in
enrollment which commenced in the second quarter of 2022 and study
close out activities in the third quarter of 2022, a decrease in
expenses associated with HONEDRA® in Japan related to study close
out costs partially offset by the addition of Chemistry,
Manufacturing, and Controls (“CMC”) activities for LSTA1, and
enrollment activities for Australasian Gastrointestinal Trials
Group (“AGITG”) ASCEND study. Research and development in both
periods related to:
- expenses associated with our XOWNA®
Phase 2b study (the FREEDOM Trial);
- expenses associated with our
registration-eligible study for HONEDRA® in CLI in Japan as well as
corresponding regulatory discussions and support expenses;
- expenses associated with the
preparation of our filing of an Investigational New Drug
Application, as well as study execution expenses for the clinical
study of LSTA201 for treatment of DKD, a Phase 1b, open-label,
proof-of-concept trial which includes six subjects in total;
- expenses associated with the
addition of CMC activities for LSTA1, enrollment activities for the
LSTA1 Phase 2b ASCEND study and preparatory activities associated
with the design of a planned LSTA1 proof-of-concept basket trial in
various solid tumors and in combination with the corresponding
standards of care.
General and administrative expenses, which focus on general
corporate related activities, were $3.9 million for the three
months ended September 30, 2022, compared to $2.8 million for the
three months ended September 30, 2021, representing an increase of
39%. This increase was primarily due to an increase in equity
expense as a result of performance stock unit vesting, a one-time
merger option assumption expense and departing board member
restricted stock unit vesting in addition to an increase in
expenses associated with our annual stockholder meeting and the
merger.
Net losses were $37.4 million for the three months ended
September 30, 2022, compared to $6.9 million for the three months
ended September 30, 2021.
Balance Sheet Highlights
As of September 30, 2022, the Company had cash, cash
equivalents and marketable securities of approximately $75.5
million.
Conference Call
Information
Lisata will hold a live conference call today, November 10, 2022,
at 4:30 p.m. Eastern time to discuss financial results, provide a
business update and answer questions.
The Company is utilizing a new conference call service. Those
wishing to participate must register for the conference call by way
of the following link: CLICK HERE TO REGISTER. Registered
participants will receive an email containing conference call
details for dial-in options. To avoid delays, we encourage
participants to dial into the conference call fifteen minutes ahead
of the scheduled start time.
A live webcast of the call will also be accessible under the
Investors & News section of Lisata’s website and will be
available for replay beginning two hours after the conclusion of
the call for 12 months.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company
dedicated to the discovery, development, and commercialization of
innovative therapies for the treatment of advanced solid tumors and
other major diseases. Lisata’s lead investigational product
candidate, LSTA1 (formerly known as CEND-1), is designed to modify
the tumor microenvironment by activating a novel uptake pathway
that allows anti-cancer drugs to penetrate solid tumors more
effectively. LSTA1 actuates an active transport system in a
tumor-specific manner, resulting in systemically co-administered
anti-cancer drugs more efficiently penetrating and accumulating in
the tumor, while normal tissues are not affected. LSTA1 has
demonstrated favorable safety, tolerability, and activity in
clinical trials to enhance delivery of standard-of-care
chemotherapy for pancreatic cancer. Lisata and its collaborators
have also amassed significant non-clinical data demonstrating
enhanced delivery of a range of emerging anti-cancer therapies,
including immunotherapies and RNA-based therapeutics. Lisata is
exploring the potential of LSTA1 to enable a variety of treatment
modalities to treat a range of solid tumors more effectively. In
addition, Lisata also has clinical development programs based on
its autologous CD34+ cell therapy technology platform. For more
information on the Company, please visit www.lisata.com.
Forward-Looking Statements
This communication contains “forward-looking statements” that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. All statements, other than statements of historical
facts, included in this communication regarding strategy, future
operations, future financial position, future revenue, projected
expenses, prospects, plans and objectives of management are
forward-looking statements. In addition, when or if used in this
communication, the words “may,” “could,” “should,” “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and
similar expressions and their variants, as they relate to Lisata or
its management, may identify forward-looking statements. Examples
of forward-looking statements include, but are not limited to,
statements relating to the long-term success of Lisata’s recently
completed merger (the “Merger”) with Cend Therapeutics, Inc.
(“Cend”), including the ongoing integration of Cend’s operations;
Lisata’s continued listing on the Nasdaq Capital Market;
expectations regarding the capitalization, resources and ownership
structure of Lisata; the approach Lisata is taking to discover and
develop novel therapeutics; the adequacy of Lisata’s capital to
support its future operations and its ability to successfully
initiate and complete clinical trials; and the difficulty in
predicting the time and cost of development of Lisata’s product
candidates. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including, without limitation: the ongoing COVID-19
pandemic on Lisata’s business, the safety and efficacy of Lisata’s
product candidates, decisions of regulatory authorities and the
timing thereof, the duration and impact of regulatory delays in
Lisata’s clinical programs, Lisata’s ability to finance its
operations, the likelihood and timing of the receipt of future
milestone and licensing fees, the future success of Lisata’s
scientific studies, Lisata’s ability to successfully develop and
commercialize drug candidates, the timing for starting and
completing clinical trials, rapid technological change in Lisata’s
markets, the ability of Lisata to protect its intellectual property
rights; unexpected costs, charges or expenses resulting from the
Merger; potential adverse reactions or changes to business
relationships resulting from the completion of the Merger;
potential underperformance of Lisata’s business following the
Merger as compared to management’s initial expectations; and
legislative, regulatory, political and economic developments. The
foregoing review of important factors that could cause actual
events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that
are included herein and elsewhere, including the risk factors
included in Lisata’s Annual Report on Form 10-K filed with the SEC
on March 22, 2022 and Exhibit 99.2 to Lisata’s Amendment No. 1 to
Current Report on Form 8-K filed on October 4, 2022, and in other
documents filed by Lisata with the Securities and Exchange
Commission. Except as required by applicable law, Lisata undertakes
no obligation to revise or update any forward-looking statement, or
to make any other forward-looking statements, whether as a result
of new information, future events or otherwise.
Contact:
Investors and Media:Lisata Therapeutics, Inc.John MendittoVice
President, Investor Relations and Corporate
CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com
- Tables to Follow –
Lisata
Therapeutics, Inc. |
|
Selected
Financial Data |
|
(in
thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
(in thousands, except per share data) |
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
Research and development |
$ |
3,380 |
|
|
$ |
4,125 |
|
|
$ |
9,898 |
|
|
$ |
13,530 |
|
|
In-process research and development |
|
30,393 |
|
|
|
- |
|
|
|
30,393 |
|
|
|
- |
|
|
General and administrative |
|
3,947 |
|
|
|
2,843 |
|
|
|
10,770 |
|
|
|
8,671 |
|
|
Total operating expenses |
|
37,720 |
|
|
|
6,968 |
|
|
|
51,061 |
|
|
|
22,201 |
|
|
Operating loss |
|
(37,720 |
) |
|
|
(6,968 |
) |
|
|
(51,061 |
) |
|
|
(22,201 |
) |
|
Investment income, net |
|
337 |
|
|
|
41 |
|
|
|
496 |
|
|
|
111 |
|
|
Other expense, net |
|
- |
|
|
|
- |
|
|
|
(149 |
) |
|
|
(90 |
) |
|
Net loss before benefit from income taxes and
noncontrolling interests |
|
(37,383 |
) |
|
|
(6,927 |
) |
|
|
(50,714 |
) |
|
|
(22,180 |
) |
|
Benefit from income taxes |
|
- |
|
|
|
- |
|
|
|
(2,479 |
) |
|
|
(1,508 |
) |
|
Net loss attributable to Lisata Therapeutics, Inc. common
stockholders |
$ |
(37,383 |
) |
|
$ |
(6,927 |
) |
|
$ |
(48,235 |
) |
|
$ |
(20,672 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Lisata
Therapeutics, Inc. common stockholders |
$ |
(7.88 |
) |
|
$ |
(1.74 |
) |
|
$ |
(11.28 |
) |
|
$ |
(5.76 |
) |
|
Weighted average common shares outstanding |
|
4,747 |
|
|
|
3,974 |
|
|
|
4,276 |
|
|
|
3,587 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
(unaudited) |
|
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
$ |
75,530 |
|
|
$ |
94,970 |
|
|
Total assets |
|
|
|
|
|
78,529 |
|
|
|
97,008 |
|
|
Total liabilities |
|
|
|
|
|
6,758 |
|
|
|
5,008 |
|
|
Total equity |
|
|
|
|
|
71,771 |
|
|
|
92,000 |
|
|
|
|
|
|
|
|
|
|
|
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