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, provides a business update and reports
financial results for the three and twelve months ended December
31, 2022.
“Last year (2022) was a year of major transformation, excitement
and renewed energy for Lisata, allowing us to enter 2023 with
growing momentum as we continue to build an enduring pharmaceutical
company,” stated David J. Mazzo, Ph.D., Chief Executive Officer of
Lisata. “We believe in the potential of our new development
pipeline and take pride in the advancement of our clinical studies
in oncology and other serious diseases. 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 anti-cancer agents. Based on substantial
preclinical and, importantly, early human clinical data, 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.
Dr. Mazzo continued, “We are dedicated to continued efficient
execution of our studies and, eventually, to producing definitive
data hopefully confirming the promise of our clinical development
pipeline. We anticipate that such execution and those data will
result in increased shareholder value while prompting additional
attractive partnering opportunities. I look forward to providing
further updates on our progress in the coming weeks and
months.”
Development Portfolio Update
LSTA1 (formerly CEND-1) as a treatment for solid tumor
cancers in combination with other anti-cancer agents
LSTA1 is an investigational drug designed to activate a novel
uptake pathway that allows co-administered or tethered anti-cancer
drugs to penetrate solid tumors more effectively. LSTA1 actuates
this 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 also has the potential to modify the tumor
microenvironment, with the objective of making tumors more
susceptible to immunotherapies. We and our collaborators have
amassed significant non-clinical data demonstrating enhanced
delivery of a range of emerging anti-cancer therapies, including
immunotherapies and RNA-based therapeutics. To date, LSTA1 has also
demonstrated favorable safety, tolerability and activity in
completed and ongoing clinical trials designed to test its ability
to enhance delivery of standard-of-care chemotherapy for pancreatic
cancer. 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, formerly 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 during 2023. Concomitantly, the Company has
reinforced its efforts to secure a Japanese partner to complete the
remaining steps of registration as well as eventual
commercialization in Japan.
XOWNA® (LSTA16, formerly 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 as well as the FREEDOM Trial,
a Phase 2b study conducted in the U.S. 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.
Based on that and the input of Key Opinion Leaders, the Company
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. 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 (formerly 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 were in the pre-dialysis stage of kidney
disease and exhibited rapidly progressing stage 3b disease. The
protocol provided 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. The principal read-out of data was based on the 6-month
follow-up visit for all patients. A key criterion for continued
development of LSTA201 was determined, a priori, to be the ability
of LSTA201 to demonstrate a therapeutic effect that will make it
competitive in the field of DKD treatment, i.e., kidney function
regeneration, as indicated by increased Glomerular Filtration Rate
(“GFR”). The Company treated the first patient in the LSTA201
proof-of-concept study in April 2022 and completed treatment for
all six subjects during the third quarter of 2022. Top line
results, which were reported on February 6, 2023, showed that
LSTA201 was safe and well-tolerated by patients with no serious
adverse events related to the therapy. However, the study did not
demonstrate a consistent improvement in kidney function among
patients. Nevertheless, the Company, based on the encouragement of
the study’s principal investigator/key opinion leader, believes
there may still be potential for use of CD34+ cell therapy for the
treatment of DKD. However, it is expected that further development
of LSTA201 would require significantly larger studies and capital
investment. Thus, LSTA201 development will only be continued if a
strategic partner that can contribute the necessary capital for
future development is identified.
Fourth Quarter and Full Year 2022 Financial
Highlights
Research and development expenses for the fourth quarter of 2022
were $3.2 million, a 22% decrease compared with $4.1 million for
the fourth quarter of 2021, and $13.1 million for the year ended
December 31, 2022 compared to $17.6 million for the year ended
December 31, 2021, representing a decrease of approximately 26%.
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 and one off recruiting expenses and interim
chief medical officer consulting expenses in the prior year
partially offset by the addition of manufacturing activities for
LSTA1 and enrollment activities for the 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 critical limb ischemia in Japan as well as
corresponding regulatory discussions 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;
and
- Expenses associated with the
addition of manufacturing 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 $3.3 million for the three
months ended December 31, 2022, representing an increase of 22%
compared to $2.7 million for the three months ended December 31,
2021, and $14.1 million for the year ended December 31, 2022,
representing an increase of 23% compared to $11.5 million for the
year ended December 31, 2021. This was primarily due to a one-time
increase in fees associated with the review of potential strategic
transactions and merger related costs, an increase in equity
expense as a result of performance stock unit vesting, 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. Our general and
administrative expenses are comprised of general corporate-related
activities.
Overall, net losses were $54.2 million (includes non-routine
merger related in-process research and development expense of $30.4
million) and $27.5 million for the years ended December 31, 2022
and 2021, respectively.
Balance Sheet Highlights
As of December 31, 2022, the Company had cash, cash
equivalents and marketable securities of approximately $69.2
million. Current projections predict operating cash through the
first half of 2025, encompassing anticipated data milestones from
several ongoing and/or planned clinical studies.
Conference Call
Information
Lisata will hold a live conference call today, March 30, 2023, 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), LSTA1 is an
investigational drug designed to activate a novel uptake pathway
that allows co-administered or tethered anti-cancer drugs to
penetrate solid tumors more effectively. LSTA1 actuates this 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 also has the potential to modify the tumor
microenvironment, with the objective of making tumors more
susceptible to immunotherapies 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 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 30, 2023 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 December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
(in thousands, except per share data) |
(unaudited) |
|
(unaudited) |
|
|
|
|
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
Research and development |
$ |
3,219 |
|
|
$ |
4,127 |
|
|
$ |
13,067 |
|
|
$ |
17,576 |
|
|
In-process research and development |
|
- |
|
|
|
- |
|
|
|
30,393 |
|
|
|
- |
|
|
General and administrative |
|
3,322 |
|
|
|
2,722 |
|
|
|
14,141 |
|
|
|
11,474 |
|
|
Total operating expenses |
|
6,541 |
|
|
|
6,849 |
|
|
|
57,601 |
|
|
|
29,050 |
|
|
Operating loss |
|
(6,541 |
) |
|
|
(6,849 |
) |
|
|
(57,601 |
) |
|
|
(29,050 |
) |
|
Investment income, net |
|
556 |
|
|
|
40 |
|
|
|
1,052 |
|
|
|
151 |
|
|
Other expense, net |
|
(6 |
) |
|
|
15 |
|
|
|
(155 |
) |
|
|
(75 |
) |
|
Net loss before benefit from income taxes and
noncontrolling interests |
|
(5,991 |
) |
|
|
(6,794 |
) |
|
|
(56,704 |
) |
|
|
(28,974 |
) |
|
Benefit from income taxes |
|
- |
|
|
|
- |
|
|
|
(2,479 |
) |
|
|
(1,508 |
) |
|
Net loss |
|
(5,991 |
) |
|
|
(6,794 |
) |
|
|
(54,225 |
) |
|
|
(27,466 |
) |
|
Less - net income (loss) attributable to noncontrolling
interests |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net loss attributable to Lisata Therapeutics, Inc. common
stockholders |
$ |
(5,991 |
) |
|
$ |
(6,794 |
) |
|
$ |
(54,225 |
) |
|
$ |
(27,466 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Lisata
Therapeutics, Inc. common stockholders |
$ |
(0.76 |
) |
|
$ |
(1.70 |
) |
|
$ |
(10.47 |
) |
|
$ |
(7.45 |
) |
|
Weighted average common shares outstanding |
|
7,861 |
|
|
|
3,985 |
|
|
|
5,180 |
|
|
|
3,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
$ |
69,226 |
|
|
$ |
94,970 |
|
|
Total assets |
|
|
|
|
|
73,034 |
|
|
|
97,008 |
|
|
Total liabilities |
|
|
|
|
|
6,710 |
|
|
|
5,008 |
|
|
Total equity |
|
|
|
|
|
66,324 |
|
|
|
92,000 |
|
|
|
|
|
|
|
|
|
|
|
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