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 second quarter ended June 30, 2023.
“The second quarter generated strong momentum for Lisata. We
continued to advance multiple ongoing and planned clinical studies
centered around our lead investigational product, LSTA1,” stated
David J. Mazzo, Ph.D., President and Chief Executive Officer of
Lisata. “Of note, we implemented key changes to the Phase 2b ASCEND
trial which now includes an additional cohort of subjects for the
evaluation of a second dose of LSTA1 in patients with first-line,
metastatic pancreatic ductal adenocarcinoma (“mPDAC”). We intend to
use the results of ASCEND to explore possible conditional approvals
globally and to design an optimized Phase 3 program. We also saw
the initiation of the iLSTA study in Australia and the launch of
our BOLSTER trial, which is the first fully sponsored study of
LSTA1 by Lisata. Finally, we are delighted to announce that we have
entered into a technology transfer agreement for our Tumor
Penetrating Nanocomplex (TPN) Platform with Impilo Therapeutics,
Inc. (“Impilo”), a newly formed company being led by former Lisata
Chief Business Officer, David Slack. We are pleased that the TPN
technology will be in the hands of a team of people with deep
expertise in the field of RNA-based therapeutics development.”
Dr. Mazzo continued, “Also, notably, in this quarter we took a
number of cash conservation decisions which resulted in the
extension of projected capital supporting operations into the first
quarter of 2026. Now with more than two years of capital available
on our balance sheet based on our current expected capital needs,
we believe we are well-placed to focus on the execution of our
development plans and achieve our goal of getting to meaningful
clinical data readouts as soon as possible.”
Development Portfolio Highlights
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. In preclinical models, LSTA1 has also
shown the ability to modify the tumor microenvironment, thereby
making tumors more susceptible to immunotherapies. Lisata and its
development 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 multiple ongoing or
planned Phase 1b/2a and 2b clinical studies being conducted
globally in a variety of solid tumor types in combination with a
variety of anti-cancer regimens. These studies include:
- ASCEND: Phase 2b double-blind, randomized, placebo-controlled
clinical trial evaluating LSTA1 in patients with mPDAC. The trial
is being conducted at up to 40 sites in Australia and New Zealand
led by the Australasian Gastro-Intestinal Trials Group in
collaboration with the University of Sydney and with the National
Health and Medical Research Council Clinical Trial Centre at the
University of Sydney as the Coordinating Centre. Enrollment
completion is projected for the second quarter of 2024; however,
current enrollment already exceeds 70% of the target, so earlier
enrollment completion may be achieved.
- BOLSTER: Phase 2a placebo-controlled basket trial in the U.S.,
Europe, Canada, and Asia evaluating LSTA1 in combination with
standards of care in advanced solid tumors including head and neck,
esophageal and cholangiocarcinoma. Enrollment is now open and the
Company hopes to soon announce the first patient treated.
- CENDIFOX: Phase 1b/2a open-label trial in the U.S. of LSTA1 in
combination with neoadjuvant FOLFIRINOX based therapies in
pancreatic, colon and appendiceal cancers. The trial continues to
make steady progress with enrollment completion expected by the
fourth quarter of 2023 and data readouts in 2024.
- LSTA1 is currently being evaluated in combination with
gemcitabine and nab-paclitaxel in a Phase 1b/2a open-label trial in
China led by Qilu Pharmaceutical. During the 2023 ASCO Annual
Meeting, Qilu Pharmaceutical presented an abstract sharing
preliminary data from the study which, thus far, has corroborated
previously reported findings from the phase 1b/2a trial of LSTA1
plus gemcitabine and nab-paclitaxel conducted in Australia in
patients with mPDAC. Final data is expected by the end of the
second quarter of 2024.
- iLSTA: Phase 1b/2a randomized, single-blind, single-center,
safety and pharmacodynamic trial in Australia evaluating LSTA1 in
combination with the checkpoint inhibitor, durvalumab, plus
standard-of-care chemotherapy, nab-paclitaxel and gemcitabine,
versus standard-of-care alone in patients with locally advanced
non-resectable PDAC. Enrollment completion is expected by the end
of the second quarter of 2024.
- The Company plans to study LSTA1 in combination with
temozolomide in Glioblastoma Multiforme (“GBM”). This study is
designed as a Phase 2a double-blind, placebo-controlled,
randomized, proof-of-concept study evaluating LSTA1 when added to
standard of care temozolomide versus temozolomide and matching
LSTA1 placebo in subjects with newly diagnosed GBM. It will be
conducted across multiple sites in Estonia and Latvia and is
targeted to enroll 30 patients with a randomization of 2:1 LSTA1 +
SoC versus Placebo + SoC. Target for first patient treated is in
the fourth quarter of 2023. Importantly and as the Company recently
announced, LSTA1 has been granted orphan designation by the U.S.
FDA for malignant glioma. This action by the FDA not only
highlights the unmet medical need but also recognizes the potential
of LSTA1 to benefit patients in this indication.
- Lisata is also planning to study LSTA1 in combination with
HIPEC interoperative intraperitoneal lavage in peritoneal
carcinomatosis, which develops as a result of the contiguous spread
of primary cancers such as ovarian, colorectal and appendiceal
along the peritoneum. The study is a Phase I single-center,
unblinded, randomized controlled trial to determine the safety and
tolerability of LSTA1 administered intraperitoneally in patients
with peritoneal metastases from colorectal, appendiceal, or ovarian
cancer undergoing Cytoreductive Surgery (“CRS”) and HIPEC.
Twenty-one total participants will be randomized 2:1 to receive
LSTA1 with HIPEC versus HIPEC alone after CRS. We anticipate that
this study will also be up and running in the fourth quarter of
2023 and the first patient being treated shortly thereafter.
Tumor Penetrating Nanocomplex (TPN) Platform Technology
Transfer
The tumor penetrating nanocomplex (TPN) platform targets
intracellular delivery of RNA-based drugs to prevent solid tumor
growth. The TPN is designed so that it could not only bind a
protein overexpressed on the surface of human cancer cells, but
also pass through the membrane by way of a cell-penetrating
peptide. Once inside the cells, the TPN is expected to release an
RNA-based drug directed against the tumor. Lisata has agreed
to transfer this technology to Impilo. Under the terms of the
technology transfer agreement, Lisata will receive an equity stake
in Impilo upon closing. Lisata is not obliged to commit any capital
or additional resources to the program’s future development.
Second Quarter 2023 Financial Highlights
Research and development expenses remained constant at
approximately $3.2 million for the three months ended June 30, 2023
and three months ended June 30, 2022. Expenses this quarter were
primarily due to study start up activities associated with the
LSTA1 BOLSTER trial, enrollment activities for the LSTA1 ASCEND
study and chemistry, manufacturing and control (CMC) activities for
LSTA1 to support all development activities.
General and administrative expenses were approximately $3.7
million for the three months ended June 30, 2023, compared to $3.5
million for the three months ended June 30, 2022, representing an
increase of $0.2 million or 6.5%. This was primarily due to
severance costs associated with the elimination of the Chief
Business Officer position on May 1, 2023, partially offset by
non-recurring merger related costs in the prior year.
Overall, net losses were $4.0 million for the three months ended
June 30, 2023, compared to $6.6 million for the three months ended
June 30, 2022, a decrease of approximately 40% primarily due to
$2.2 million in non-dilutive funding received as an approved
participant of the Technology Business Tax Certificate Transfer
Program sponsored by the New Jersey Economic Development
Authority.
Balance Sheet Highlights
As of June 30, 2023, the Company had cash, cash equivalents
and marketable securities of approximately $57.6 million. Based on
its current expected capital needs, the Company believes that its
projected capital will fund its current proposed operations into
the first quarter of 2026 encompassing anticipated data milestones
from all its ongoing and planned clinical trials.
Conference Call
Information
Lisata will hold a live conference call on Tuesday, August 15,
2023, at 8:30 a.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. Based on Lisata’s
CendR Platform® Technology, Lisata has already established
noteworthy commercial and R&D partnerships. The Company expects
to announce numerous clinical study and business milestones over
the next two years and has projected that its current business and
development plan is funded with available capital through these
milestones and into early 2026. 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 and capital, 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 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 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; 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 Jun 30, (QTD) |
|
Six Months Ended Jun 30, (YTD) |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
(in thousands, except per share data) |
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
Research and development |
$ |
3,162 |
|
|
$ |
3,234 |
|
|
$ |
6,341 |
|
|
$ |
6,516 |
|
|
General and administrative |
|
3,713 |
|
|
|
3,486 |
|
|
|
7,378 |
|
|
|
6,824 |
|
|
Total operating expenses |
|
6,875 |
|
|
|
6,720 |
|
|
|
13,719 |
|
|
|
13,340 |
|
|
Operating loss |
|
(6,875 |
) |
|
|
(6,720 |
) |
|
|
(13,719 |
) |
|
|
(13,340 |
) |
|
Investment income, net |
|
668 |
|
|
|
94 |
|
|
|
1,338 |
|
|
|
158 |
|
|
Other expense, net |
|
(150 |
) |
|
|
- |
|
|
|
(163 |
) |
|
|
(149 |
) |
|
Net loss before benefit from income taxes and
noncontrolling interests |
|
(6,357 |
) |
|
|
(6,626 |
) |
|
|
(12,544 |
) |
|
|
(13,331 |
) |
|
Benefit from income taxes |
|
(2,330 |
) |
|
|
- |
|
|
|
(2,330 |
) |
|
|
(2,479 |
) |
|
Net loss |
|
(4,027 |
) |
|
|
(6,626 |
) |
|
|
(10,214 |
) |
|
|
(10,852 |
) |
|
Less - net income attributable to noncontrolling interests |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net loss attributable to Lisata Therapeutics, Inc. common
stockholders |
$ |
(4,027 |
) |
|
$ |
(6,626 |
) |
|
$ |
(10,214 |
) |
|
$ |
(10,852 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to Lisata
Therapeutics, Inc. common stockholders |
$ |
(0.50 |
) |
|
$ |
(1.64 |
) |
|
$ |
(1.28 |
) |
|
$ |
(2.69 |
) |
|
Weighted average common shares outstanding |
|
8,021 |
|
|
|
4,035 |
|
|
|
8,004 |
|
|
|
4,036 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jun 30, 2023 |
|
December 31, 2022 |
|
|
|
|
|
|
(unaudited) |
|
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
$ |
57,626 |
|
|
$ |
69,226 |
|
|
Total assets |
|
|
|
|
|
62,365 |
|
|
|
73,034 |
|
|
Total liabilities |
|
|
|
|
|
4,651 |
|
|
|
6,710 |
|
|
Total equity |
|
|
|
|
|
57,714 |
|
|
|
66,324 |
|
|
|
|
|
|
|
|
|
|
|
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