Shares of biopharmaceutical company Caladrius Biosciences Inc (NASDAQ:CLBS) are soaring nearly 25% to $6.35 in pre-market trading Tuesday. All of this appears to be a result of CLBS’s announcement this morning that it has entered into a definitive agreement with Shire (NASDAQ:SHPG) to acquire a late stage CD34+ cell therapy program for the treatment of chronic myocardial ischemia targeting refractory angina. Valuation-wise, it’s hard to say whether CMC is getting a good price on this asset.
Under the terms of the agreement, Caladrius acquired the exclusive worldwide rights to the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina. In exchange, Shire will receive undisclosed up-front consideration, milestones and a royalty on product sales.
The comprehensive data set that Caladrius licensed includes preclinical (in vivo and in vitro) and Phase 1, Phase 2 and Phase 3 clinical study data of CD34 cell therapy as a treatment for no-option refractory angina, along with the corresponding regulatory filings.
The program is supported by data from 3 randomized placebo controlled trials.1,2,3 A recent publication in the European Heart Journal, entitled “Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials” combines the data from all three studies encompassing over 300 patients and reveals statistically significant improvements in mortality, exercise capacity and chest pain frequency.
“Prior to joining Caladrius, I designed and was principal investigator of the Phase 1 and Phase 2 studies of this CD34+ therapy that were conducted with the support of Baxter. I also designed and launched the Phase 3 study at Baxter prior to its spinoff of Baxalta and Baxalta’s subsequent merger with Shire. Given my intimate knowledge of this clinical program, I am very excited by our acquisition of this data license and remain positive about the prospects for this therapy as a treatment for patients suffering with refractory angina,” stated Douglas W. Losordo, MD, FACC, FAHA, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer of Caladrius. “Preclinical studies have established the mechanism of action of CD34+ cell therapy in restoring microcirculation and improving myocardial tissue perfusion and clinical trials have shown clinical benefit in a patient population that had exhausted all other available therapeutic options.4,5,6 We believe that the growing body of clinical data in support of CD34+ cell therapy as a treatment for refractory angina is very encouraging and we believe that Caladrius is uniquely positioned to advance this late-stage program through to potential regulatory approval.”
“This transaction offers an ideal opportunity for Caladrius to obtain a promising late-stage development asset complementary to our existing pipeline of CD34+ cell therapy development programs in ischemic repair,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. “This program represents a large potential commercial opportunity as refractory angina afflicts approximately one million people in the U.S. alone, with an incidence rate of 50,000 to 100,000 annually.7 We look forward to discussing with the FDA the most expeditious regulatory path aimed at registration for this CD34+ cell therapy program and to bringing this potentially restorative therapy to patients in need.”
In a recent research note, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on CLBS, with a price target of $7.00, which implies a potential upside of nearly 18% from current levels.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Ram Selvaraju has a yearly average return of -10.3% and a 32.3% success rate. Selvaraju has a 5.4% average return when recommending CLBS, and is ranked #4718 out of 4772 analysts.