On May 5, 2022 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease, reported financial results for the three months ended March 31, 2022 and provided a business update (Press release, Caladrius Biosciences, MAY 5, 2022, View Source [SID1234613840]).
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"During the quarter, we continued to advance our CD34+ cell therapy development pipeline with the initiation of the proof-of-concept study for CLBS201 in diabetic kidney disease. However, the most important achievement was the culmination, after the close of the quarter, of our efforts to diversify and expand our development portfolio, which resulted in the recently announced signing of a merger agreement with Cend Therapeutics," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "This transaction will be transformational for Caladrius, creating, upon closing, a financially sound Nasdaq-listed company with a diverse product development pipeline, strong existing partnerships and potential for future attractive collaborations. The merged company will operate under the name of Lisata Therapeutics ("Lisata") with a primary focus on exploiting the full potential of Cend’s CendR Platform technology in a range of solid tumor oncology indications. CEND-1, the lead product candidate from the CendR Platform, has the potential to be combined with a myriad of chemo and immunotherapeutic agents and nanoparticle technology that could become an integral part of a revised standard of care therapy for many difficult to treat cancers. The collaboration with Cend will allow the Caladrius team to leverage its broad development expertise and experience, specifically in oncology, with the goal of rapidly progressing Lisata’s product development candidates toward global registrations. We couldn’t be more excited and motivated about the prospects that this merger will bring for patients and shareholders."
Business, Product Development and Financing Highlights
Subsequent to the close of the first quarter of 2022, the Company announced that it has entered into a definitive agreement to merge with Cend Therapeutics, Inc. ("Cend"), a privately-held, clinical-stage biotechnology company focused on a novel approach to enable more effective treatments for solid tumor cancers, 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. ("Lisata") and is expected to trade on the Nasdaq Capital Market 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. In the interim, Caladrius has made an investment of $10 million in Cend in connection with a development collaboration agreement to maintain development momentum of the Cend pipeline.
HONEDRA (CLBS12) for the treatment of critical limb ischemia ("CLI")
HONEDRA is the Company’s SAKIGAKE-designated product candidate for the treatment of CLI and Buerger’s disease in Japan for which, as previously announced, the Company suspended enrollment of its registration eligible trial, CLBS12-P01, and turned its focus to securing a Japanese partner to either complete study enrollment of the four remaining patients, if necessary, and/or to explore the possibility of submitting the existing data to the Japanese Regulatory Authorities for registration review. This decision was motivated by the Company’s desire to minimize additional operational and financial burden caused by enrollment delays and the lack of visibility on time to completion of the current study. The Company expects to receive guidance from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan during the second or third quarter of 2022 on the next steps of development. In an upcoming clinical pre-consultation meeting, topline results from the CLBS12-P01 study will be presented and discussed with the PMDA. The outcome of this meeting will provide important perspective to be considered in preparation for the formal consultation meetings which precede the Japanese new drug application.
XOWNA (CLBS16) for the treatment of coronary microvascular dysfunction ("CMD")
XOWNA is an experimental regenerative therapy for the treatment of CMD. It was the subject of a positive Phase 2a study (the "ESCaPE-CMD trial") reported in 2020 and is currently being evaluated in the U.S. Phase 2b FREEDOM Trial. The FREEDOM Trial is a double-blind, randomized, placebo-controlled study designed to assess the efficacy and safety of delivering autologous CD34+ cells to subjects with CMD and without obstructive coronary artery disease. As previously communicated, enrollment in the FREEDOM Trial initially proceeded as planned with the first patient treated in January 2021; however, the impact of the COVID-19 pandemic in the U.S., coupled with supply chain issues associated with the catheters used for diagnosis of CMD and/or administration of XOWNA have made and continue to make enrollment much slower than originally predicted and challenging to accelerate. Notwithstanding the obstacles, Caladrius has taken steps to accelerate enrollment by expanding the number of participating investigational sites as well as modifying the study protocol to make study inclusion criteria more flexible. Caladrius continues to monitor the progress of the study and will consider additional future protocol and/or execution changes, as appropriate.
CLBS201 for the treatment of diabetic kidney disease ("DKD")
Progressive kidney failure is associated with attrition of the microcirculation of the kidney. Preclinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. Based on these observations, the Company recently initiated a Phase 1, open-label, proof-of-concept trial evaluating CLBS201, a CD34+ regenerative cell therapy investigational product for intra-renal artery administration in patients with DKD. Patients selected for the study will be in the pre-dialysis stage of kidney disease and will exhibit rapidly progressing stage 3b disease. The protocol provides for a staggered, sequentially dosed cohort of six patients overseen by an independent Data Safety Monitoring Board with the objective of determining the tolerance of intra-renal cell therapy injection in DKD patients as well as the ability of CLBS201 to regenerate kidney function. A key read-out of data will occur at the 6-month follow-up visit for all patients. As previously announced, the first patient was treated in this Phase 1b study of CLBS201 in April 2022 leading to top-line data from all subjects expected by the first quarter of 2023.
First Quarter 2022 Financial Highlights
Research and development expenses for the three months ended March 31, 2022, were $3.3 million, compared to $5.1 million for the three months ended March 31, 2021. Research and development activities in the current year period focused on the advancement of our ischemic repair platform and related to:
Expenses associated with efforts to continue execution and acceleration of enrollment of the FREEDOM Trial;
Expenses associated with the planning, preparation and initiation of the Phase 1b proof-of-concept trial for CLBS201 as a treatment for DKD; and
Ongoing expenses for HONEDRA in CLI and Buerger’s disease in Japan associated with study close out activities and preparation for the pre-consultation meetings with the PMDA.
General and administrative expenses, which focus on general corporate related activities, were $3.3 million for the three months ended March 31, 2022, compared to $3.0 million for the three months ended March 31, 2021, representing an increase of 11%. This increase was primarily due to an increase in fees associated with the review of potential strategic transactions.
Overall, net losses were $4.2 million and $8.1 million for the three months ended March 31, 2022 and March 31, 2021, respectively.
Balance Sheet Highlights
As of March 31, 2022, the Company had cash, cash equivalents and marketable securities of approximately $88.5 million, which positions us well relative to the projected capital obligations for our existing development programs as well as our cash and investments balance target at the time of the closing of the merger with Cend.
Conference Call
Caladrius will hold a live conference call today May 5, 2022, at 4:30 p.m. (ET) to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below. A live webcast of the call will also be available under the Investors & News section of the Caladrius website (View Source) and will be available for replay for 90 days after the conclusion of the call.
Please dial-in 10 minutes before the start of the conference call.
For those unable to participate on the live conference call, an audio replay will be available that day starting at 7:30 p.m. (ET) until May 12, 2022, by dialing 855-859-2056 (U.S. Toll-Free) or 404-537-3406 (International) and by entering the replay passcode: 7129748.