BASKING RIDGE, N.J. (September 9, 2020) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease, today announced that it has received trademark registration from the Japan Patent Office (“JPO”) for the Company’s use of HONEDRA® as the brand name for CLBS12, its SAKIGAKE-designated product candidate for the treatment of Critical Limb Ischemia (“CLI”) and Buerger’s Disease. In addition, the JPO has awarded Caladrius a new patent that will further build out the Company’s robust intellectual property portfolio. This marks the fourth patent (Japan Patent Appl. No. 2015-219241) granted in Japan to Caladrius for its CD34+ cellular therapy technology and will provide additional, broadened protection of HONEDRA®, anticipated to be approved and commercialized in Japan as early as mid-2022.
“The registration of the HONEDRA® trademark and the new patent issuance in Japan both represent key steps towards the potential approval and subsequent commercialization of CLBS12 in Japan,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. “We are committed to bringing this product to market as rapidly as possible and believe that HONEDRA® will make a meaningful difference in the lives of many patients with CLI and Buerger’s Disease.”
About Critical Limb Ischemia
CLI is a result of severe obstruction of the arteries that markedly reduces blood flow to the extremities, principally the feet and legs. CLI can lead to pain, skin ulcers and dermal sores, and, if not successfully addressed, amputation. No-option CLI means that pharmacotherapy has been ineffective and options for bypass or angioplasty have been exhausted.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease. We are developing first- in-class cell therapy products based on the notion that our body contains finely tuned mechanisms for self-repair. 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 CLBS119, a CD34+ cell therapy product candidate for the repair of lung damage found in patients with severe COVID-19 infection who have experienced respiratory failure, for which the Company plans to initiate a clinical trial in the coming weeks as well as three developmental treatments for ischemic diseases based on its CD34+ cell therapy platform: HONEDRA® (formerly CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) based on the results of an ongoing clinical trial; CLBS16, the subject of a recently completed positive Phase 2 clinical trial in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); and CLBS14, a Regenerative Medicine Advanced Therapy (“RMAT”) designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the “FDA”) a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (“NORDA”). For more information on the company, please visit www.caladrius.com.
Safe Harbor for Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements including, without limitation, all statements related to the intended use of net proceeds from financings as well as any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. Without limiting the foregoing, the words “plan,” “project,” “forecast,” “outlook,” “intend,” “may,” “will,” “expect,” “likely,” “believe,” “could,” “anticipate,” “estimate,” “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. Factors that could cause future results to differ materially from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 5, 2020 and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein, except as required by law.
Caladrius Biosciences, Inc.
Vice President, Investor Relations and Corporate Communications