Lisata Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
Lisata Therapeutics, Inc. reported strong first-quarter 2024 financial results and provided an update on its business activities. The company is anticipating pivotal data readouts from the Phase 2b ASCEND trial later in 2024, with transformative potential. They have received significant regulatory designations for their investigational drug certepetide in various cancer types. Lisata's financial management allows operations to be funded until early 2026. The company is executing multiple ongoing and planned clinical trials globally to advance their innovative therapies.
Lisata Therapeutics has a strong start to 2024 with pivotal data readouts from the Phase 2b ASCEND trial expected later in the year, which could be transformative for the Company.
The company has received significant regulatory designations for certepetide, their investigational drug, further validating its therapeutic potential in various cancer types.
Lisata's prudent financial management ensures operations can be funded until early 2026, providing a solid foundation for the completion of ongoing and planned clinical trials.
Operating expenses for the first quarter of 2024 totaled $6.6 million, representing a slight decrease from the previous year.
Net losses were reported at $5.4 million for the three months ended March 31, 2024, compared to $6.2 million for the same period in 2023.
General and administrative expenses decreased by 8.3% due to various cost-saving measures, including the elimination of the Chief Business Officer position.
Reviewing Lisata Therapeutics' first-quarter financial results reveals a moderate reduction in operating expenses, indicative of disciplined fiscal management. A slight
The slight reduction in general and administrative expenses by
Lisata's clinical update, particularly the ongoing Phase 2b ASCEND trial and the anticipated top-line data, is a central catalyst for the company's valuation. The emphasis on certepetide's mechanism—activating the CendR uptake pathway for improved drug delivery to solid tumors—highlights its potential as a pivotal oncologic agent. With orphan drug and Fast Track designations for pancreatic cancer, orphan drug designation for glioblastoma and osteosarcoma and Rare Pediatric Disease designation for osteosarcoma, Lisata has positioned certepetide as a versatile drug candidate in the high-need oncology space.
However, the real inflection point for investors will be the ASCEND trial results due in Q4 2024. The outcome of this study will be a significant variable in assessing Lisata's trajectory. A positive result could position certepetide for conditional approvals, spurring immediate interest and potential partnerships or accelerating its Phase 3 program. The implications of this data are magnified by the landscape of pancreatic cancer therapies, where unmet medical needs remain high and transformative treatments could achieve substantial market penetration.
Seminal Phase 2b ASCEND trial top-line data expected in fourth quarter of 2024
Projected available cash to fund planned operations into early 2026 covering all studies through data
Conference call scheduled for today at 4:30 p.m. Eastern Time
BASKING RIDGE, N. J., May 09, 2024 (GLOBE NEWSWIRE) -- 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, provided a business update and reported financial results for the three months ended March 31, 2024.
“2024, a pivotal year for Lisata, is off to a very strong start,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “Although we project multiple data readouts over the next 18 months, topline results from the Phase 2b ASCEND trial later this year have transformative potential for the Company. These results will be instrumental in determining the future of Lisata, and we plan to use them to explore conditional approvals with various regulatory agencies and/or to design an optimized Phase 3 program in pancreatic ductal adenocarcinoma. Since the start of the year, we have received both U.S. FDA Orphan Drug and Rare Pediatric Disease designations for certepetide, previously known as LSTA1, in osteosarcoma, further validating the broad therapeutic potential of this innovative therapy. We are energized by the progress we are making and excited about Lisata’s prospects.“
Dr. Mazzo added, “Our continued prudent financial management allows us to reaffirm our projection that currently available cash will fund operations into early 2026, providing a solid foundation to fund all ongoing and planned trials through to completion. More than ever, we remain confident in our ability to execute our development activities with the goal of reaching critical milestones at the earliest possible juncture.”
Development Portfolio Highlights
Certepetide as a treatment for solid tumors in combination with other anti-cancer agents
Certepetide is an investigational drug designed to activate the CendR uptake pathway that allows co-administered or molecularly bound anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide is designed to actuate 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, to the exclusion of normal tissues. In preclinical models, certepetide has also shown the ability to modify the tumor microenvironment, leading to the expectation that tumors will become more susceptible to immunotherapies and inhibiting the metastatic cascade (i.e., the spread of cancer to other parts of the body). Lisata and its development partners 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, certepetide 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 (“SOC”) chemotherapy for metastatic pancreatic cancer (“mPDAC”). Certepetide has been granted orphan drug designation for pancreatic cancer in the U.S. and Europe as well as for glioblastoma multiforme (“GBM”) and osteosarcoma in the U.S. It also received a Fast Track designation from the FDA for pancreatic cancer and, just recently, a Rare Pediatric Disease designation from the FDA for osteosarcoma. Currently, certepetide is the subject of multiple ongoing or planned Phase 2a and 2b clinical studies being conducted globally in a variety of solid tumor types in combination with a variety of anti-cancer regimens:
- ASCEND: Phase 2b double-blind, randomized, placebo-controlled clinical trial evaluating two dosing regimens of certepetide in combination with gemcitabine/nab-paclitaxel SOC chemotherapy in patients with mPDAC. Cohort A of the study receives a single dose of 3.2 mg/kg certepetide essentially simultaneously with SOC, while Cohort B is identical to Cohort A, but with a second dose of 3.2mg/kg of certepetide given four hours after the first. The trial is being conducted at 25 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. The conclusion of a planned interim futility analysis in 2023 by the Independent Data Safety Monitoring Committee was that the conditions for futility were not met and that the study should proceed to completion. With trial enrollment completed in the fourth quarter of 2023, Lisata expects topline data from the 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of 2024 and the complete data set of all 158 patients from the study to be available by mid-2025.
- BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SOC in first-line cholangiocarcinoma. The trial is actively enrolling with enrollment completion expected by the end of the third quarter of 2024.
- CENDIFOX: Phase 1b/2a open-label trial in the U.S. of certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. The trial continues to make steady progress with enrollment completion for all three arms expected by the end of 2024.
- Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for mPDAC. During the 2023 ASCO Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with mPDAC. As recently announced, Qilu has begun treating patients in their Phase 2 placebo-controlled trial in mPDAC. The study is planned to take approximately 18 months to complete enrollment and another 13 months for patient follow-up and data analysis and reporting.
- iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia evaluating certepetide in combination with the checkpoint inhibitor, durvalumab, plus standard-of-care gemcitabine and nab-paclitaxel chemotherapy versus standard-of-care alone in patients with locally advanced non-resectable PDAC. Enrollment completion is expected in the second half of 2024.
- A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with standard-of-care temozolomide versus temozolomide alone in patients with newly diagnosed GBM is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group.
First Quarter 2024 Financial Highlights
For the three months ended March 31, 2024, operating expenses totaled
Research and development expenses were approximately
General and administrative expenses were approximately
Overall, net losses were
Balance Sheet Highlights
As of March 31, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately
Conference Call Information
Lisata will hold a live conference call today, May 9, 2024, 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 15 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, certepetide, 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, the potential efficacy of certepetide as a treatment for patients with metastatic pancreatic ductal adenocarcinoma and other solid tumors, 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: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; 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 February 29, 2024, 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 Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com
- Tables to Follow –
| Lisata Therapeutics, Inc. | |||||||||
| Selected Financial Data | |||||||||
| (in thousands, except per share data) | |||||||||
| Three Months Ended March 31, | |||||||||
| 2024 | 2023 | ||||||||
| (in thousands, except per share data) | (unaudited) | (unaudited) | |||||||
| Statement of Operations Data: | |||||||||
| Research and development | $ | 3,241 | $ | 3,179 | |||||
| General and administrative | 3,360 | 3,665 | |||||||
| Total operating expenses | 6,601 | 6,844 | |||||||
| Operating loss | (6,601 | ) | (6,844 | ) | |||||
| Investment income, net | 589 | 670 | |||||||
| Other expense, net | (187 | ) | (13 | ) | |||||
| Net loss before benefit from income taxes and noncontrolling interests | (6,199 | ) | (6,187 | ) | |||||
| Benefit from income taxes | (798 | ) | - | ||||||
| Net loss | (5,401 | ) | (6,187 | ) | |||||
| Less - net income (loss) attributable to noncontrolling interests | - | - | |||||||
| Net loss attributable to Lisata Therapeutics, Inc. common stockholders | $ | (5,401 | ) | $ | (6,187 | ) | |||
| Basic and diluted loss per share attributable to Lisata Therapeutics, Inc. common stockholders | $ | (0.65 | ) | $ | (0.77 | ) | |||
| Weighted average common shares outstanding | 8,294 | 7,987 | |||||||
| March 31, 2024 | December 31, 2023 | ||||||||
| (unaudited) | |||||||||
| Balance Sheet Data: | |||||||||
| Cash, cash equivalents and marketable securities | $ | 43,349 | $ | 50,535 | |||||
| Total assets | 48,240 | 54,694 | |||||||
| Total liabilities | 5,497 | 6,800 | |||||||
| Total equity | 42,743 | 47,894 | |||||||
FAQ
What are Lisata Therapeutics' stock symbol and main focus?
Lisata Therapeutics' stock symbol is LSTA, and the company focuses on developing innovative therapies for advanced solid tumors and other serious diseases.
When is the topline data from the Phase 2b ASCEND trial expected?
The topline data from the Phase 2b ASCEND trial is expected to be reported in the fourth quarter of 2024.
What regulatory designations has certepetide received?
Certepetide has received U.S. FDA Orphan Drug and Rare Pediatric Disease designations in osteosarcoma, further validating its therapeutic potential.
How long is Lisata's cash projected to fund operations?
Lisata projects that their available cash will fund operations into early 2026, covering all ongoing and planned trials.
What is the financial outlook for Lisata Therapeutics in the first quarter of 2024?
Lisata reported a decrease in operating expenses and net losses for the first quarter of 2024, showcasing a financially prudent approach.
