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• LSTA1 (Drug Candidate): A clinical-stage, CEND-binding peptide designed to enhance the delivery of co-administered anti-cancer agents to solid tumors for improved efficacy.
• CEND-Platform Technology: A proprietary drug delivery platform that utilizes CEND peptides to specifically target and improve the penetration of therapeutics into the tumor microenvironment.

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Lisata Therapeutics (LSTA) is a clinical-stage biotechnology company focused on developing therapies for solid tumors and fibrotic diseases. As such, it does not sell products directly to individuals. Instead, its business model primarily involves research and development, seeking partnerships and collaborations with larger pharmaceutical companies and research institutions to further develop and potentially commercialize its drug candidates.

Therefore, Lisata Therapeutics primarily sells (or licenses its technology to, and collaborates with) other companies. Its major "customers" or strategic partners, which are crucial for its business development and potential future revenue generation, include:

• Sanofi (SNY)
• ImmunityBio, Inc. (IMNB)
• Bristol Myers Squibb (BMY)

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David J. Mazzo, Ph.D., President and Chief Executive Officer

Dr. Mazzo has over 40 years of experience in the pharmaceutical industry. He joined Lisata Therapeutics in January 2015, and was appointed President and Chief Executive Officer in March 2017. Prior to Lisata, he served as Chief Executive Officer of Regado Biosciences, Inc. (2008-2014) and Æterna Zentaris, Inc. (2007-2008). He also held positions as President, CEO, and Director of Chugai Pharma USA, LLC (2003-2007) and senior R&D roles at Schering-Plough Research Institute (which was acquired by Merck & Co., Inc.) and Hoechst Marion Roussel, Inc. (acquired by Sanofi), and Rhone-Poulenc Rorer, Inc. (acquired by Hoechst AG). Dr. Mazzo has served on the boards of several public companies, including Avanir Pharmaceuticals, Inc., which was sold to Otsuka Holdings in 2015.

James Nisco, Senior Vice President, Finance and Treasury and Chief Accounting Officer

Mr. Nisco joined Lisata in 2012 and oversees all finance activities for the company, including SEC reporting, financial reporting and accounting, treasury operations, and financial planning and analysis. He has over 30 years of experience in corporate finance, with previous senior finance positions at OSI Pharmaceuticals, Inc. (acquired by Astellas) and Ciba Corporation (acquired by The BASF Group). He began his career at Ciba-Geigy (now Novartis Pharmaceuticals).

Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer

Dr. Buck joined Lisata (formerly Caladrius Biosciences) in 2021 and is responsible for leading the company's research and development and clinical studies.

Gregory S. Berkin, Chief Information Officer and Data Protection Officer

Mr. Berkin joined Lisata (formerly Caladrius Biosciences) in 2015.

John Menditto, Vice President of Investor Relations and Corporate Communications

Mr. Menditto joined Lisata in 2017 and brings over 30 years of experience in corporate communications and investor relations, including specialization in financial modeling, Regulation FD, corporate governance, investor targeting, and capital raising. He has held senior roles at companies such as Novartis Corporation, Medco Health Solutions, and Argos Therapeutics.

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The key risks to Lisata Therapeutics (LSTA) predominantly revolve around the inherent challenges of a clinical-stage biopharmaceutical company.

1. Clinical Trial Outcomes and Regulatory Approval: As a company with drug candidates in various stages of clinical trials, Lisata Therapeutics faces significant risks related to the safety and efficacy of its product candidates, particularly certepetide (LSTA1). There is a substantial risk that promising results from early research and clinical trials may not be replicated or demonstrated in larger-scale or later-stage clinical trials. Furthermore, decisions by regulatory authorities and the timing of these decisions can cause delays or prevent the approval and commercialization of Lisata's drug candidates. Failed or inconclusive clinical trials are explicitly identified as factors that could impede the company from achieving its objectives.
2. Ability to Finance Operations: Lisata Therapeutics has consistently reported net losses and anticipates incurring further losses for the foreseeable future, potentially never achieving or sustaining profitability. The company's ability to continue its operations and advance its clinical programs is dependent on its capacity to secure adequate funding. As of Q3 2024, their cash position was projected to fund operations into early 2026, and as of Q2 2025, into the fourth quarter of 2026, indicating an ongoing need for capital to support research, development, and clinical milestones. The inability to obtain sufficient funding could severely impact the progression of its drug development pipeline.
3. Intellectual Property Protection and Competition: Lisata Therapeutics operates in a highly competitive and rapidly evolving market, facing numerous established pharmaceutical companies and biotechnology firms. The company's success relies on its ability to protect its intellectual property rights, including patents and other proprietary technologies related to its CendR Platform^® technology and drug candidates like certepetide. Competitors may develop and commercialize drugs that are safer, more effective, or less costly, or obtain regulatory approval before Lisata, which could negatively impact its market opportunities and business prospects.

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Lisata Therapeutics (LSTA), a clinical-stage biopharmaceutical company, anticipates its future revenue growth over the next 2-3 years to be primarily driven by advancements in its lead drug candidate, certepetide, and strategic partnerships.

1. Progression and Potential Commercialization of Certepetide (LSTA1) in Advanced Solid Tumors: The successful advancement of certepetide through ongoing clinical trials, particularly the ASCEND trial in metastatic pancreatic ductal adenocarcinoma and other studies in glioblastoma and bile duct cancer, is a key driver. Positive data readouts and subsequent progression towards or into Phase III trials are critical. While direct product sales may extend beyond the 2-3 year timeframe, successful clinical milestones could trigger significant licensing agreements, milestone payments, or early commercialization partnerships that would contribute to revenue.
2. Revenue from Strategic Alliances and Licensing Agreements: Lisata Therapeutics has actively pursued and secured partnerships, such as the global license agreement with Catalent to evaluate certepetide in its SMARTag Antibody-Drug Conjugate (ADC) technology platform. The company also formed a strategic alliance with GATC Health to utilize their AI-powered drug discovery platform. These collaborations are expected to generate revenue through upfront payments, milestone achievements, and potential royalties as the partnered programs advance.
3. Expansion of the Drug Pipeline through AI-Driven Discovery: The strategic alliance with GATC Health is designed to optimize and accelerate drug discovery, including identifying new product candidates for clinical trials as early as 2026 and exploring new indications and combination therapies for certepetide. This expansion of the pipeline could lead to future revenue streams from new drug candidates or broader applications of existing ones.
4. Positive Data from Ongoing Clinical Trials: The announcement of encouraging preliminary and final results from various ongoing trials, including ASCEND, iLSTA, and CENDIFOX, serves as a significant catalyst. Strong clinical data demonstrating efficacy and safety for certepetide in combination with existing cancer treatments enhances the compound's value, attracts potential partners, and supports its progression toward regulatory approvals, which can lead to future revenue generation.

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Share Issuance

• Lisata Therapeutics raised $600,663 in net proceeds through its At-the-Market (ATM) program during the nine months ending September 30, 2025.
• Shareholders' equity decreased to $29.6 million in fiscal year 2024 from $48.2 million in the prior year.
• The company reported $74,000 in shares issued for the quarter ended June 2025.

Inbound Investments

• Lisata Therapeutics has raised a total of $6.58 million in funding across 10 rounds, with its latest Seed funding round amounting to $2 million on July 15, 2020.
• In fiscal year 2024, the company secured $0.9 million in non-dilutive funding via the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer Programme.
• As of September 30, 2025, the company reported approximately $19.0 million in cash and cash equivalents, which is projected to fund operations into the first quarter of 2027.

Capital Expenditures

• Research and development (R&D) expenses for the three months ended September 30, 2025, were approximately $2.0 million, representing a 22.9% year-over-year decrease.
• This reduction in R&D spending was primarily due to lower expenses in chemistry, manufacturing, and controls, and a decrease in Clinical department costs, partially offset by increased costs for the BOLSTER trial.
• Lisata Therapeutics is actively managing its cash by delaying certain Phase 3 readiness activities, focusing its expenditures on advancing its lead drug candidate, certepetide, through ongoing clinical trials.