Stonegate Capital Partners Initiates Coverage on Pluristem Therapeutics, Inc.
DALLAS, TX / ACCESSWIRE / July 5, 2016 / Stonegate Capital Partners initiates research coverage on Pluristem Therapeutics, Inc. (PSTI).
Company Description
Founded in 2001, Pluristem Therapeutics, Inc. is a clinical-stage biotechnology company focused on regenerative therapeutics. Its technology involves converting cells derived from human placentas into patented PLX (PLacental eXpanded) cells using its proprietary three-dimensional bioreactor platform. The PLX cells are programmed to release therapeutic proteins in response to inflammatory, ischemic and hematological conditions. The cells can be used as "off-the-shelf" products--they require no tissue matching prior to administration. They can be produced in commercial quantities in Pluristem's GMP-certified manufacturing facility. The Company's clinical-stage products, PLX-PAD and PLX-R18, address indications in multi-billion dollar markets, including cardiovascular, orthopedic, pulmonary, hematological, and women's health conditions. Pluristem employs approximately 170 people and is headquartered in Haifa, Israel.
Summary
The combination of a pipeline of products that address large patient populations with critical unmet needs, positive data that validate its therapies, strategic partnerships, and an experienced management team working closely with global regulatory agencies, is opening doors for early entry into markets in the U.S. and abroad. To date, the Company has completed three clinical trials with successful results, and three pivotal trials are planned to begin in 2016. Pluristem is well-positioned to be a global leader in regenerative medicine for the following reasons:
Pluristem has a broad platform with its patented PLX cells that are engineered to secrete a specific cytokine secretion profile, targeting different indications, most of which address sizable market opportunities with limited or no treatment options.
The Company's unique manufacturing technology addresses the limitations of the standard process of manufacturing cell therapies. Using proprietary bioreactors to simulate the 3D structure of the body, the self-controlled, fully computerized platform is many times more efficient than current 2D methods. The platform is scalable, cost effective and capable of creating 150,000 doses of commercial grade cells annually with consistent quality.
The Company-owned, GMP-certified manufacturing and research facility is approved by the FDA, as well as the German, EU, South Korean, Japanese and Israeli regulatory agencies for Phase II, III trials and marketing.
One of Pluristem's most compelling advantages is its extensive intellectual property portfolio consisting of over 60 issued patents and over 150 pending applications in the U.S., Europe, China, Japan, Israel, South Africa, South Korea, Mexico, Russia and South America.
PSTI is exploiting regulatory programs in the EU and Japan that provide accelerated pathways to near-term commercialization. Using results from two successful Phase I trials in critical limb ischemia (CLI), Pluristem was accepted into both regulatory programs (and no other company in the world has been accepted into both programs). These programs could allow the Company to bypass Phase III trials and tens of millions of dollars in development costs. The Company is slated to initiate pivotal trials in 2016, which could lead to commercialization authorization late 2018 or early 2019.
Using the FDA Animal Rule, the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) has initiated studies in large animals to assess the proper dosage for PLX-R18. The Animal Rule eliminates the need for clinical efficacy trials in humans (Phases II and III typically), and approval could come quickly, possibly in 2017.
In Q4 2015, the FDA granted Orphan Drug status to Pluristem's product for preeclampsia, a potentially life threatening condition in pregnant women for which there is no treatment except delivery. Orphan Drug designation generally accelerates the time to market, and provides a seven-year market exclusivity period.
Utilizing discounted flow analysis of the CLI opportunity alone, we arrive at a valuation range of $5.51 - $6.27, with a midpoint of approximately $6.
The full report can be accessed by clicking the following link: http://stonegateinc.com/reports/PSTI_July_2016_Final.pdf.
About Stonegate Capital Partners
Stonegate Capital Partners is a Dallas-based corporate advisory firm dedicated to serving the specialized needs of small-cap public companies. Since our inception, our mission has been to find innovative, undervalued public companies for our network of leading institutional investors who seek high quality investment opportunities.
SOURCE: Stonegate Capital Partners
