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 months ended March 31, 2023.
“During the first quarter of 2023, our team
continued its focus on the advancement of multiple ongoing and
planned clinical studies evaluating LSTA1, our lead investigational
product," stated David J. Mazzo, Ph.D., Chief Executive Officer of
Lisata. “We expect to report progress on several of these
activities over the coming months and quarters. Just recently, we,
along with our research partner, WARPNINE, announced the treatment
of the first patient in the iLSTA Trial in Australia evaluating
LSTA1 in combination with standard-of-care chemotherapy and
immunotherapy as a first-line treatment in locally advanced
non-resectable pancreatic ductal adenocarcinoma. We are hopeful
that this and our other trials will continue to show the potential
of LSTA1 in combination with corresponding standards-of-care as
well as with emerging treatment modalities, such as
immunotherapies, as an effective treatment against various solid
tumors.
Dr. Mazzo continued, "Our overarching goal is to
report meaningful clinical data to benefit patients and to support
our development pipeline in the most expeditious manner possible.
Positive data should also bring value to shareholders and encourage
additional partnering opportunities.”
Development Portfolio Update
LSTA1 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 expected to be 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
existing and emerging anti-cancer therapies, including
chemotherapeutics, 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
metastatic pancreatic ductal adenocarcinoma in combination with
each of the two standards-of-care for this disease. The combination
of LSTA1 with corresponding standards-of-care in other solid tumor
indications is planned for clinical study commencing before the end
of the second quarter of 2023.
HONEDRA® (LSTA12) 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 the subject of
discussions with the PMDA as part of the Japanese regulatory
pre-consultation process and in preparation for the formal clinical
consultation meetings which precede a Japanese new drug
application. To date, the PMDA has provided advice on how to
prepare for the formal consultation meeting. Concomitantly, the
Company has reinforced its efforts to secure a partner to complete
the remaining steps of development/registration and potential
commercialization in Japan through the engagement of an advisory
firm specializing in Japanese partnerships.
LSTA201 for the treatment of diabetic kidney disease
(“DKD”)
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. Preclinical studies in kidney
disease and injury models have demonstrated that protecting or
replenishing the microcirculation of the kidney may result in
improved kidney function. A key criterion for continued development
of LSTA201 was determined, a priori, to be the ability of LSTA201
to regenerate kidney function as indicated by increased Glomerular
Filtration Rate. 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.
First Quarter 2023 Financial Highlights
Research and development expenses were
approximately $3.2 million for the three months ended March 31,
2023, compared to $3.3 million for the three months ended March 31,
2022, representing a decrease of $0.1 million or 3.2%. This was
primarily due to expenses associated with our XOWNA® Phase 2b study
(the FREEDOM Trial) in the prior year, partially offset by study
start up activities in the current year associated with the planned
LSTA1 Phase 2 proof-of-concept basket trial in various solid tumors
in combination with the corresponding standards of care, enrollment
activities for the LSTA1 Phase 2b ASCEND study and chemistry,
manufacturing and control activities for LSTA1.
General and administrative expenses were
approximately $3.7 million for the three months ended March 31,
2023, compared to $3.3 million for the three months ended March 31,
2022, representing an increase of $0.3 million or 9.8%. This was
primarily due to the addition of one employee acquired through the
Company’s merger with Cend Therapeutics, Inc., an increase in
external legal fees and an increase in accounting and tax-related
fees.
Overall, net losses were $6.2 million for the three months ended
March 31, 2023, compared to $4.2 million for the three months ended
March 31, 2022.
Balance Sheet Highlights
As of March 31, 2023, the Company had cash,
cash equivalents and marketable securities of approximately $61.1
million. These figures do not include the recently announced $2.2
million in non-dilutive funding received as an approved participant
of the Technology Business Tax Certificate Transfer Program (the
“Program”) sponsored by the New Jersey Economic Development
Authority, which will be recorded in the second quarter of 2023.
The Program enables qualifying New Jersey-based biotechnology or
technology companies to sell a percentage of their New Jersey net
operating losses and research and development tax credits to
unrelated qualifying corporations. The Company is confident that
its projected capital will fund its operations into the first
quarter of 2026 encompassing anticipated data milestones from all
of its ongoing and planned clinical trials.
Conference Call
Information
Lisata will hold a live conference call today, May 9, 2023, at 4:30
p.m. Eastern time to discuss financial results, provide a business
update and answer questions.
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 with 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
product candidate, LSTA1, is an investigational drug designed to
activate a novel uptake pathway that allows co-administered or
tethered anti-cancer drugs to target and 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 existing and emerging anti-cancer
therapies, including chemotherapeutics, 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. 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, 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 Mar 31, |
|
|
|
2023 |
|
2022 |
|
(in thousands, except per share data) |
|
(unaudited) |
|
(unaudited) |
|
Statement of Operations Data: |
|
|
|
|
|
Research and development |
|
$ |
3,179 |
|
|
$ |
3,283 |
|
|
General and administrative |
|
|
3,665 |
|
|
|
3,337 |
|
|
Total operating expenses |
|
|
6,844 |
|
|
|
6,620 |
|
|
Operating loss |
|
|
(6,844 |
) |
|
|
(6,620 |
) |
|
Investment income, net |
|
|
670 |
|
|
|
63 |
|
|
Other expense, net |
|
|
(13 |
) |
|
|
(148 |
) |
|
Net loss before benefit from income taxes and
noncontrolling interests |
|
|
(6,187 |
) |
|
|
(6,705 |
) |
|
Benefit from income taxes |
|
|
- |
|
|
|
(2,479 |
) |
|
Net loss |
|
|
(6,187 |
) |
|
|
(4,226 |
) |
|
Less - net income attributable to noncontrolling interests |
|
|
- |
|
|
|
- |
|
|
Net loss attributable to Lisata Therapeutics, Inc. common
stockholders |
|
$ |
(6,187 |
) |
|
$ |
(4,226 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Lisata
Therapeutics, Inc. common stockholders |
|
$ |
(0.77 |
) |
|
$ |
(1.05 |
) |
|
Weighted average common shares outstanding |
|
|
7,987 |
|
|
|
4,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
|
(unaudited) |
|
|
|
Balance Sheet Data: |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
61,095 |
|
|
$ |
69,226 |
|
|
Total assets |
|
|
66,326 |
|
|
|
73,034 |
|
|
Total liabilities |
|
|
5,623 |
|
|
|
6,710 |
|
|
Total equity |
|
|
60,703 |
|
|
|
66,324 |
|
|
|
|
|
|
|
|
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