1. A clinical-stage Bristol Myers Squibb (BMS), but specializing in advanced cellular therapies for tissue regeneration.

2. An earlier-stage Novartis, focused on developing cellular therapies to reverse disease and regenerate damaged tissue.

• HONEDRA: A cellular therapy in Phase II clinical trial for the treatment of critical limb ischemia.
• XOWNA: A cellular therapy in Phase IIb clinical trial for the treatment of coronary microvascular dysfunction.
• CLBS201: A CD34+ cell therapy for the treatment of pre-dialysis patients with chronic kidney disease.

Lisata Therapeutics (LSTA), as described, is a clinical-stage biopharmaceutical company. This means the company is primarily focused on the research, development, and clinical trials of its cellular therapies (HONEDRA, XOWNA, CLBS201). At this stage, its product candidates are still undergoing testing and have not yet received regulatory approval for commercial sale. Therefore, Lisata Therapeutics does not currently have major customers for its products in the traditional sense (i.e., companies or individuals purchasing its therapies).

Clinical-stage biopharmaceutical companies typically derive their funding from sources such as venture capital, public offerings, grants, or partnerships with larger pharmaceutical companies for co-development or future commercialization. However, these are generally considered investors or partners rather than "customers" purchasing finished products.

David J. Mazzo, PhD
President and Chief Executive Officer

Dr. Mazzo joined Lisata Therapeutics as CEO in January 2015 and was appointed President and CEO in March 2017. He has over 40 years of experience in the pharmaceutical industry, having held executive positions in R&D at large multinational companies such as Hoechst Marion Roussel (later acquired by Sanofi) and Schering-Plough (later acquired by Merck & Co., Inc.). Dr. Mazzo also served as CEO for emerging pharmaceutical companies including Chugai USA, Aeterna Zentaris, and Regado Biosciences. He has served on the board of directors of companies such as Avanir Pharmaceuticals, Inc., which was sold to Otsuka Holdings in 2015. He is currently the Chairman of the Board of Visioneering Technologies, Inc. (ASX:VTI) and a Director of Feldan Therapeutics, a private company.

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

Mr. Nisco joined Lisata in 2012 and was promoted to Senior Vice President, Finance and Treasury, and Chief Accounting Officer in April 2024, making him the principal financial and accounting officer. He possesses 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, MD
Executive Vice President of R&D and Chief Medical Officer

Dr. Buck continued in her role as Executive Vice President of R&D and Chief Medical Officer at Lisata Therapeutics following the merger of Caladrius Biosciences and Cend Therapeutics in September 2022. She is actively involved in the company's research and development efforts, contributing to discussions on novel therapies.

Tariq Imam
Senior Vice President, Business Development and Operations and General Counsel

Mr. Imam is a member of the management team at Lisata Therapeutics, serving as Senior Vice President of Business Development and Operations and General Counsel. In this capacity, he is responsible for the company's business development strategies and legal affairs.

Gregory S. Berkin
Chief Information Officer and Data Protection Officer

Mr. Berkin holds the positions of Chief Information Officer and Data Protection Officer at Lisata Therapeutics. His responsibilities include overseeing the company's information technology infrastructure and ensuring compliance with data protection regulations.

Key Risks to Lisata Therapeutics (LSTA)

Lisata Therapeutics (LSTA), a clinical-stage biopharmaceutical company, faces several key risks inherent to its sector and current corporate developments.

1. Uncertainty and Potential Failure of the Pending Acquisition by Kuva Labs: Lisata Therapeutics has entered into a definitive agreement to be acquired by Kuva Labs, Inc., through a tender offer. The transaction is structured to provide shareholders with cash and a contingent value right, with an expected closing in the second quarter of 2026. The most immediate and significant risk to Lisata as a publicly traded entity is the possibility that this acquisition may not be consummated due to unfulfilled conditions or other unforeseen circumstances. A failure of the tender offer and subsequent merger could leave the company to continue as an independent entity, potentially in a more challenging operational and financial position.
2. High-Risk Nature of Clinical-Stage Drug Development and Regulatory Hurdles: As a clinical-stage biopharmaceutical company, Lisata's success is fundamentally tied to the successful development, clinical testing, and regulatory approval of its product candidates, particularly certepetide (LSTA1) for advanced solid tumors. There is no assurance that its investigational therapies will demonstrate safety and efficacy in larger-scale clinical trials or receive the necessary regulatory approvals, which could result in substantial financial losses and negatively impact the company's long-term viability. Factors such as unforeseen adverse events, insufficient efficacy, or regulatory delays are constant threats.
3. Financial Sustainability and Continuous Need for Capital: Lisata Therapeutics is currently an unprofitable company, reporting significant net losses (e.g., $16.6 million in 2025 and $20.0 million in 2024). Its ability to sustain operations and fund its extensive research and development pipeline, including ongoing and planned clinical trials, relies heavily on securing additional capital. While the company has projected its existing capital to fund operations into late 2026 or early 2027, the availability and terms of future funding are uncertain, especially given the challenging market for small-cap biotech companies. A prolonged inability to raise sufficient capital could hinder drug development and operational continuity.

Lisata Therapeutics (LSTA) - Addressable Market Sizes for Main Products/Services:

• Certepetide (LSTA1) for Advanced Solid Tumors (including pancreatic cancer, cholangiocarcinoma, and appendiceal cancers): Null
• XOWNA® (for Coronary Microvascular Dysfunction - CMD): Null
• LSTA12 (HONEDRA® in Japan) for Critical Limb Ischemia (CLI):
  • Global: The critical limb ischemia treatment market was valued at approximately USD 4.90 billion in 2022 and is projected to reach around USD 10.41 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 7.35% from 2025 to 2034.
  • 7 Major Markets (7MM): The market reached a value of USD 1.4 billion in 2024 and is expected to reach USD 2.5 billion by 2035.
  • U.S.: The U.S. critical limb ischemia treatment market size was estimated at USD 1.54 billion in 2024 and is predicted to be worth approximately USD 3.18 billion by 2034.
• LSTA201 (CD34+ cell therapy for Chronic Kidney Disease - CKD, also referred to as Diabetic Kidney Disease - DKD):
  • Global: The global chronic kidney disease market size was valued at USD 90.41 billion in 2025. It is projected to grow from USD 96.33 billion in 2026 to USD 160.02 billion by 2034, exhibiting a CAGR of 6.55% during the forecast period.
  • 7 Major Markets (7MM): The market was approximately USD 2.824 billion in 2023 and is expected to grow by 2034.
• LSTA14 (OLOGO™ in the USA) for No-Option Refractory Disabling Angina (NORDA): Null

Lisata Therapeutics (LSTA) is focused on the discovery, development, and commercialization of innovative therapies, primarily for advanced solid tumors and other major diseases. Over the next 2-3 years, the company's expected drivers of future revenue growth are primarily centered around its lead product candidate, certepetide, and its underlying CendR Platform® Technology, along with potential strategic collaborations and pipeline expansion:

1. Advancement and Potential Commercialization of Certepetide (LSTA1) in Oncology Indications: Lisata's lead product candidate, certepetide (also known as LSTA1), is an investigational drug designed to activate a novel uptake pathway that allows co-administered anti-cancer drugs to more effectively target and penetrate solid tumors. Positive clinical trial outcomes, particularly from the ongoing Phase 2b ASCEND trial for metastatic pancreatic ductal adenocarcinoma (mPDAC) with complete data expected by mid-2025, are crucial. Successful clinical development and subsequent regulatory approvals would enable market entry and generate significant revenue through product sales. Certepetide has already received Orphan Drug status in pancreatic cancer and Fast Track designation from the FDA, underscoring its potential.

2. Strategic Partnerships and Licensing Agreements for the CendR Platform® Technology: Lisata's proprietary CendR Platform® Technology is designed to enhance drug delivery to solid tumors. This platform's broad applicability to various anti-cancer agents presents opportunities for strategic collaborations and licensing agreements with other pharmaceutical companies. These partnerships could provide upfront payments, milestone payments upon achieving specific development or regulatory goals, and royalties on future product sales, contributing to revenue growth.

3. Expansion and Advancement of the Broader Pipeline: Beyond certepetide, Lisata Therapeutics maintains a broader clinical-stage pipeline that includes other investigational therapies. These include XOWNA® for coronary microvascular dysfunction and LSTA201 for diabetic kidney disease, which were part of its legacy Caladrius pipeline. Successful development and potential commercialization of these additional product candidates could diversify future revenue streams and open new market opportunities.

Share Issuance

• Following the merger with Cend Therapeutics in September 2022, prior Caladrius stockholders collectively owned approximately 52% and prior Cend stockholders collectively owned approximately 48% of the combined company.
• In June 2024, shareholders approved the addition of 600,000 shares to the 2018 Equity Incentive Compensation Plan and increased shares for the 2017 Employee Stock Purchase Plan from 68,333 to 113,333.
• Under an At The Market Offering Agreement, Lisata Therapeutics issued 68,496 shares of common stock during the six months ended June 30, 2025, and raised $0.60 million through this ATM program in Q3 2025.

Inbound Investments

• Immediately following the merger in September 2022, Lisata Therapeutics had approximately $76 million in cash and investments.
• In May 2022, prior to the merger, Caladrius Biosciences made a $10 million investment in Cend Therapeutics as part of a collaboration agreement to support Cend's development pipeline.
• In March 2026, Lisata Therapeutics entered a definitive agreement to be acquired by Kuva Labs through a tender offer of $5.00 per share in cash, plus a contingent value right (CVR) for an additional $1.00 per share upon achievement of certain regulatory milestones for certepetide.

Outbound Investments

• In May 2022, Caladrius Biosciences invested $10 million in Cend Therapeutics under a collaboration agreement to advance Cend's development programs before their merger.

Capital Expenditures

• For the three months ended September 30, 2025, research and development expenses were approximately $2 million, with year-to-date R&D expenses totaling $6.815 million.
• These expenditures are primarily focused on advancing Lisata's clinical development pipeline, including its CendR Platform™ technology product candidates for oncology and its autologous CD34+ cell therapy technology platform.
• The company projects that available funds will support current operations and planned activities into the first quarter of 2027.