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Caladrius Biosciences (Nasdaq: CLBS) reported solid financial results for Q4 and 2020, showcasing resilience amid COVID-19. The company's cash reserves reached approximately $116 million following successful capital raises in January and February 2021, ensuring funding for ongoing clinical trials, including the FREEDOM trial for CLBS16 and the HONEDRA® study in Japan. Research and development expenses decreased by 14% year-over-year. Caladrius is advancing several cell therapy programs targeting coronary microvascular dysfunction and chronic kidney disease, with promising early clinical data.
Caladrius Biosciences (Nasdaq: CLBS) will announce its financial results for Q4 and the full year of 2020 on February 25, 2021, at 4:30 p.m. ET. The company focuses on developing cellular therapies aimed at reversing diseases. Key product candidates include CLBS16 for coronary microvascular dysfunction, HONEDRA® (CLBS12) for critical limb ischemia in Japan, and CLBS201 targeting chronic kidney disease. A live conference call will be held, with a replay available until March 4, 2021.
Caladrius Biosciences (Nasdaq: CLBS) has successfully closed two direct offerings. The first includes 24,906,134 shares and warrants to purchase up to 12,453,067 shares, priced at $2.45 per share, with warrants exercisable at $2.90 for five years. The second offering comprises 1,632,652 shares and warrants for 816,326 shares under similar terms. The net proceeds will be allocated for working capital and advancing CD34+ technology-based clinical programs.
Caladrius Biosciences (Nasdaq: CLBS) announced the execution of securities purchase agreements with institutional investors to sell 24,906,134 shares of common stock and warrants for $2.45 per share. The warrants are exercisable at $2.90 and expire in five years. The gross proceeds are estimated to be around $65 million, allocated for working capital and advancing CD34+ clinical programs. Additionally, a non-brokered direct offering of 1,632,652 shares is planned, also closing around February 17, 2021.
Caladrius Biosciences (Nasdaq: CLBS) has completed a private placement selling 12,500,000 shares and warrants for $25 million at $2.00 per share. The warrants have an exercise price of $2.90, are immediately exercisable, and valid for 5.5 years. Proceeds will support working capital and advance CD34+ technology clinical programs. The issuance is exempt from public offering registration under the Securities Act. Caladrius must file a resale registration statement within 10 days for investor shares.
Caladrius Biosciences (Nasdaq: CLBS) announced its participation in several virtual conferences in February 2021, highlighting its commitment to cellular therapies aimed at reversing disease. The events include the LSX World Congress (Feb 1-5), Charlotte CIO Executive Leadership Summit (Feb 4), and BIO CEO & Investor Digital Conference (Feb 16-18). Presenters will include CEO David J. Mazzo and CIO Greg S. Berkin. The company's leading product candidates include HONEDRA® for critical limb ischemia and OLOGO™ for refractory angina, among others.
Caladrius Biosciences (Nasdaq: CLBS) announced a private placement to raise $25 million by issuing 12.5 million shares at $2.00 each, along with warrants for an additional 6.25 million shares. The placement, expected to close around January 25, 2021, will fund working capital and advancements in its CD34+ technology programs. The warrants, exercisable immediately at $2.90, have a term of 5.5 years. The company must register the shares with the SEC within ten days, aiming for effective status within 90 days.
Caladrius Biosciences announced the initiation of its Phase 2b FREEDOM trial for CLBS16, targeting coronary microvascular dysfunction (CMD). The trial will enroll 105 patients across the U.S., focusing on efficacy and safety of CD34+ cell therapy. The first patient has been treated at The Christ Hospital in Ohio. Following positive results from the previous Phase 2a ESCaPE-CMD trial, strong interest from investigators and patients is noted. This milestone highlights the urgent need for effective CMD treatments, particularly affecting women, amidst the COVID-19 pandemic.
Caladrius Biosciences (Nasdaq: CLBS), a clinical-stage biopharmaceutical firm focused on cellular therapies, announced the participation of its President and CEO, David J. Mazzo, PhD, in several virtual investor conferences throughout January 2021. Key events include the H.C. Wainwright Virtual BioConnect Conference on January 11-14, the Biotech Showcase Digital 2021 from January 11-15, and NobleCon17 on January 19-20. The company is developing therapies aimed at reversing diseases, including HONEDRA® for critical limb ischemia and CLBS14 for disabling angina.
Caladrius Biosciences (Nasdaq: CLBS) has completed its year-end portfolio review, optimizing its development strategy for 2021. The company aims to use its available capital effectively through 2021 despite challenges from the COVID-19 pandemic. Key programs include CLBS16, targeting coronary microvascular dysfunction, and HONEDRA, facing enrollment disruptions in Japan due to the pandemic. Caladrius plans to file for CLBS201 for chronic kidney disease in Q2 2021, while discussing CLBS14 regulatory strategies with the FDA. The development of CLBS119 is on hold due to a lack of patients.
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