Caladrius Biosciences & Cend Therapeutics Announce Definitive Merger Agreement

Caladrius Biosciences, Inc. and Cend Therapeutics, Inc. recently announced the companies have entered into a definitive merger agreement under which Cend will merge with a wholly owned subsidiary of Caladrius in an all-stock approximate “merger of equals” transaction unanimously approved by the Boards of Directors of each company. Following closing, the combined company will be renamed Lisata Therapeutics, Inc. and will trade on the Nasdaq under the ticker symbol LSTA. The merger is currently expected to close in the third quarter of 2022 subject to the approval of Caladrius and Cend stockholders as well as the satisfaction of certain other customary closing conditions and applicable approvals.

“As we communicated to our shareholders frequently over the last year, Caladrius has been seeking to identify and evaluate strategic development opportunities with the aim of consummating transactions that will deliver additional value to our shareholders beyond our current development pipeline. After a comprehensive review of available opportunities and with the aid of specialized consultants, we concluded that a merger with Cend provides Caladrius shareholders with an attractive opportunity for potential value creation by immediately expanding and diversifying our development portfolio,” said David J. Mazzo, PhD, President and CEO of Caladrius. “We believe that Cend’s technology has the potential to deliver novel and improved treatments in patients with solid tumor cancers with a lead program in pancreatic cancer that already has shown great promise based on early clinical data. Furthermore, we expect that the complementarity of expertise, experience, and resources between the two companies will accelerate the development and availability to patients of this innovative and potentially important new cancer treatment.”

“Our team has spent the past several years developing and advancing a novel and differentiated approach to treat solid tumor cancers. The CendR Platform provides a targeted tissue penetration capability, which is designed to specifically enhance drug delivery to solid tumors. Cend’s lead investigational drug, CEND-1, has been combined with other anticancer products to potentially enable more effective treatment of difficult to treat solid tumor cancers,” said David Slack, CEO of Cend. “For us, an attractive aspect of this business combination is the addition of Caladrius’ development team, which has experience and expertise in a diverse array of therapeutic areas, including oncology. We are excited to be working together to improve outcomes for cancer patients.”

Following the closing of the merger, Lisata is expected to advance CEND-1 as its lead product candidate in a variety of difficult to treat solid tumor applications, including pancreatic ductal adenocarcinoma (PDAC), where the product is being evaluated in ongoing Phase 1 and Phase 2 clinical studies with Cend and its partner in China, Qilu Pharmaceutical. CEND-1 is a proprietary cyclic peptide which undergoes protease mediated cleavage in the tumor microenvironment producing a C-end Rule or “CendR” peptide that potentiates transport across the tumor stroma and improves delivery of anticancer drugs to the tumor. Additional Phase 1b/2 PDAC clinical data is expected as early as 2023. Lisata also plans to initiate an additional trial in PDAC in combination with immunotherapy as well as a trial or trials exploring applications of CEND-1 in other difficult to treat solid tumors, such as hepatocellular, gastric and breast cancers along with additional therapeutic combinations. We see CEND-1’s advancement as supported by compelling Phase 1b data previously presented at the 2020 European Society for Molecular Oncology (ESMO), which not only demonstrated favorable safety and tolerability, but importantly, the potential for marked improvement in treatment effectiveness in combination with standard of care drugs for PDAC. With its unique tumor-targeted, tissue penetrating technology, we believe that the CendR Platform holds the potential to enable more effective solid tumor treatment for a range of emerging treatment modalities, including RNA-based drugs. We believe that this could provide Lisata with additional partnering and product opportunities to benefit cancer patients and Lisata shareholders.

Under the terms of the definitive merger agreement, David J. Mazzo, PhD, current President and CEO of Caladrius will be the Chief Executive Officer of Lisata, David Slack, current President and CEO of Cend, will be Lisata’s President and Chief Business Officer, and Kristen K. Buck, MD, current Executive Vice President of R&D and Chief Medical Officer, will continue in those roles with Lisata. Upon closing, shareholders of Cend will receive approximately 60.5 million shares of Caladrius common stock, subject to certain closing conditions, resulting in the shareholders of each company owning approximately 50% of the combined company. The transaction values each company at $90 million, which for Caladrius represents a 136% premium to its market cap as of the market close on April 26, 2022. At the effective time of the merger, the Board of Directors of Lisata is expected to comprise four directors designated by Caladrius and four directors designated by Cend, with the possibility of one additional independent director, whose appointment will be mutually agreed upon by both Caladrius and Cend.

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. We are and have been developing first-in-class autologous cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication. The company’s current product candidates include: XOWNA (CLBS16), the subject of both a recently completed positive Phase 2a study and an ongoing Phase 2b study (www.freedom-trial.com) in the US for the treatment of coronary microvascular dysfunction (CMD); CLBS12 (HONEDRA in Japan), recipient of a SAKIGAKE designation in Japan and eligible for early conditional approval for the treatment of critical limb ischemia (CLI) and Buerger’s disease based on the results of an ongoing clinical trial; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (DKD). No assurance can be given with respect to the future of these programs. For more information, visit www.caladrius.com.

Cend is a clinical-stage biotech company focused on a novel approach to enable more effective treatments for solid tumor cancers. The CendR Platform provides a tumor-targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness. For more information, visit www.cendrx.com.