קרן מרדכי
23/07/2019
לקרנות המשקיעות בפלוריסטם לחץ כאן
אנליסט הביוטכנולוגיה של Ladenburg Thalmann, מת'יו קפלן מתחיל לסקר את מניית פלוריסטם עם המלצת "קנייה" ומחיר יעד של 2.8 דולר ל-12 החודשים הקרובים, מחיר הגבוה פי 4.63 ממחירה כיום (פרמיה של 363% ביחס למחיר הנוכחי) .
קפלן שמתייחס לשלבי הפיתוח המתקדמים בהן נמצאות התוויות מרכזיות של שני מוצרי הריפוי של פלוריסטם, ומציין כי הוא מעודד מהממצאים שהתקבלו בשלבי הניסוי המוקדמים, ומשרטט את לוחות הזמנים האפשריים לקבלת אישורי שיווק באירופה ובארה"ב, כותב בהמלצתו: "צנרת חזקה של תוכניות עם מגוון רחב של קטליזטורים פוטנציאליים וצפי למכירות שיעלו על 900 מיליון דולר" ומסיים את ההמלצה הראשונית כך: "אנו מאמינים כי פלוריסטם מייצגת הזדמנות השקעה אטרקטיבית ומתחילים לסקר אותה עם המלצת קנייה ומחיר יעד של 2.8 דולר למניה".
PLURISTEM THERAPEUTICS, INC.
Initiating Coverage of Pluristem Therapeutics, Inc.; BUY Rating and $2.80 PT
Highlights
Pluristem focuses on the development of placenta-derived cell therapy products for the treatment of several indications. Pluristem Therapeutics, Inc. (PSTI) is a clinical-stage company that develops allogeneic, off-the-shelf placenta-based cell therapy product candidates for the treatment of inflammation, ischemia, muscle injuries, hematological disorders, and exposure to radiation. Pluristem's lead indications are hip fracture, critical limb ischemia (CLI), and acute radiation syndrome (ARS), which are all severe unmet medical needs.
Solid pipeline of programs with multiple potential catalysts and projected total peak sales of over $900M. Pluristem is currently focused on the development of two cell therapy products, PLX-PAD and PLX-R18. PLX-PAD is being developed as a potential treatment for muscle regeneration after hip fracture surgery and critical limb ischemia (CLI). The company’s second product in clinical development is PLX-R18, which is being developed as a treatment for acute radiation syndrome (ARS).
PLX-PAD Is currently in Phase 3 development for muscle regeneration following arthroplasty for hip fracture. Pluristem expects this Phase 3 study to be completed in 2H 2020. We believe, if the results of the Phase 3 study are positive with a strong statistical significance, they are likely to suffice for approval in the U.S. and could serve as the basis for approval in Europe in 2H 2021.
PLX-PAD Phase 1/2 study showed positive efficacy and safety profiles in patients for muscle regeneration after total hip arthroplasty. The Phase 1/2 study results showed PLX-PAD cells resulted in substantial and clinically significant improvement in gluteus medius muscle strength and volume compared to placebo in patients following total hip arthroplasty.
PLX-PAD is currently also in a Phase 3 trial for the treatment of CLI. Pluristem expects an interim data readout from half of the patient population (n=~123) in 1H 2020, which could serve as the basis for approval in Europe. We believe if the results of the Phase 3 study, expected in 1H 2021, are positive with a strong statistical significance, they could serve as the basis for approval in both the U.S. and in Europe in 2022.
Positive PLX-PAD Phase 1 and Phase 2 data showed the cell product was safe and well-tolerated and treatment resulted in positive efficacy in peripheral artery disease (PAD) patients. We are encouraged by the Phase 1/2 study results showing improvement of quality of life and TpCO2 with increases in amputation-free survival (AFS) and reduced pain score in CLI patients, as well as a substantial improvement in maximum walking distance in intermittent claudication (IC) patients.
PLX-R18 Phase 1 and 2 trials for the treatment of ARS showed the treatment is safe and well-tolerated with clear evidence of clinical activity. We are encouraged by the Phase 1 and Phase 2 results showing PLX-R18 cells resulted in improvement in survival rate, body weight, and blood counts post-irradiation. The study also showed a clean safety profile and demonstrated it does not affect survival or blood counts of unirradiated animals.
We believe Pluristem represents an attractive investment opportunity and initiate coverage with a Buy rating and $2.80 price target. Altogether, we value Pluristem at $2.80 per share, which is supported by our sum-of-the-parts, rNPV, DCF, and EPS multiple valuations of its lead programs.
