Caladrius CEO Predicts Tenfold Market Cap Rise As Pipeline ‘Validates’ Itself
Executive Summary
The CEO of US-based Caladrius Biosciences believes its share price will rise at least tenfold over the next three years as the cell therapy specialist’s pipeline advances to commercialization.
With its first product on track for approval soon in Japan, Caladrius Biosciences Inc. is planning its transition over the next three years from a late-stage developer of cell therapies to one commercializing treatments for ischemic diseases. The evolution should see the US group’s share price rise steadily as its pipeline "validates itself", CEO David Mazzo told Scrip.
Caladrius Biosciences has product candidates in development based on two technology platforms, one targeting autoimmune and one targeting cardiology indications.
The biotech, which has no products on the market yet, is developing clinical-stage products that harvest, concentrate and restore to patients their CD34+ cells to address three widespread and difficult-to-treat conditions: critical limb ischemia (CLI), chronic microvascular dysfunction (CMD) and no option refractory disabling angina (NORDA).
“We have two technology platforms: one is our T regulatory cell platform, which our product candidate CLBS03 is part of, and which we are exploring in use in autoimmune diseases,” Mazzo said.
“Our other platform, which is actually our primary focus, uses CD34+ cells, which naturally reside in the bone marrow, to restore microvasculature in tissues.”
That treatment consists of patients suffering from insufficient blood supply receiving CD34+-rich fluid, derived from blood taken from them in a process aimed at promoting the generation of new microvasculature, new capillaries and new tissues.
CLBS12
“The product in our pipeline that’s most likely to reach the market first is CLBS12, which is being developed for CLI and is eligible for early approval in Japan under SAKIGAKE designation,” Mazzo said.
CLBS12, currently in Phase II testing, is an autologous therapy that uses an individual's cells, which are cultured and expanded outside the body, and reintroduced into the donor.
“CLBS12 is eligible for early approval in Japan and we hope to have top line data from the ongoing Phase II trial by the first half of 2020 and this could be an approved product in Japan as early as 2021, Mazzo said, adding: “We’re looking forward to partnering CLBS12 with a Japanese pharmaceutical company, and we have a number of interested parties and discussions are moving into the advanced stage now.”
He said the estimated initial commercial opportunity in Japan is more than $100m. Aproval in Japan would support development of CLBS12 in the US and the EU, he added.
CLBS14
“After CLBS12, the next asset in our pipeline that’s likely to move to commercialization will be our product candidate CLBS14 in the NORDA (No Option Refractory Disabling Angina) program, and which will start Phase III later this year,” Mazzo said.
“We currently estimate that it will then take three years before we get top line NORDA data for CLBS14; if that comes say in early 2023, under an ideal scenario that could be an approved product in the US by late 2023 or early 2024. The CLBS16 program for Coronary Microvascular Dysfunction would follow closely behind that,” Mazzo said.
Caladrius Biosciences would be open to commercial partnering in countries other than Japan, provided the terms were attractive.
“That said, the NORDA program and indication would be manageable for us in the US despite our small size, because the infrastructure would allow for that.”
Rising Profile Expected
Mazzo said he expected the group’s product – and investment – profile to become more prominent over the next three to four years.
“In three years’ time we’d like to see ourselves with a product partnered and launched in Japan, and a US counterpart program in CLI initiated,” he explained.
“We’d also at that time like to see us wrapping up the NORDA program in the United States with an eye towards a smooth and rapid registration product in the US and a potential partnering there. And I’d like to see the CMD program in Phase III at that point."
“I’d also hope that at that time the market will show a better understanding of what we’re doing and that that would translate into a much increased stock price.”
He added, “Right now, we believe our share price is held back by our very heavy retail shareholder base, and that’s something that we expect will convert over the next several years.
“Our goal is to see our market cap 10 times higher than it is today in market value, if not greater, with products and revenue either in hand or immediately on the horizon and with additional products in our pipeline, as either new indications for CD34+, of which there are several, and also having decided on the next steps for our autoimmune platform.”