Pluristem's CEO Letter to Shareholders (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market.

Pluristem Chairman and CEO Zami Aberman released a letter to shareholders providing updates on the company's recent achievements, clinical and pre-clinical activities and their potential ramifications, as well as a finance update.

He writes,

"The past few months have been both busy and exciting for Pluristem. We have made great strides towards executing our strategy of developing a patient friendly, minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our whole team was moved and proud of the remarkable recovery of the seven year old girl we recently treated in a compassion treatment with our PLX cells. I believe that this case reminds us all that our first and primary goal is to help save the lives of patients."

Read the full letter at Pluristem.com.

Doctors credit stem cell therapy for saving girl's life (Video) (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market.

The Company recently announced that the compassionate use of its PLX Cells had saved the life of a young Romanian girl suffering from aplastic bone marrow, a condition in which patients have no blood-forming hematopoietic stem cells in their bone marrow. Her doctor, Professor Reuven Or, explained that "With her body rejecting all possible treatment -- and with no other options -- we finally turned to Pluristem's PLX cells, which literally saved her life." Read more. 

Below is a video from Reuters about the girl, her condition, and the remarkable reversal of her disease. 

Pluristem Therapeutics announces preclinical results of PLacental eXpanded administration (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market.

The Company announced that "cardiac function in a diabetic-induced diastolic dysfunction in animals improved following PLacental eXpanded (PLX cells) administration. The study was conducted as part of the European Commission's Seventh Framework Program (FP7) in collaboration with Professor Doctor Carsten Tschöpe and his staff at the Charite Universitaetsmedizin Berlin, Berlin-Bradenburg Center for Regenerative Therapies (BCRT), Berlin, Germany. Dr. Tschöpe is also a member of the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology."

Dr. Tschoumlpe stated,

"Currently, there are limited treatment options for diastolic dysfunction and even fewer options for diabetic induced diastolic dysfunction. This study holds promise that PLX cells might be able to inhibit diabetic induced diastolic dysfunction progression as well as possibly repair the existing damage, hypotheses that will be further explored in future studies."

Chairman and CEO of Pluristem Zami Aberman commented,

"As we demonstrated last week with the announcement that our cells successfully treated the seven years old patient suffering from aplastic bone marrow disease, our strategy is to develop a minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our initial testing of a treatment for diastolic heart disease opens a new potential indication where our cells can be used and potentially positions Pluristem as a "first-line of defense" for diastolic dysfunction. Based on these studies as well as the previously announced acute myocardial infarction data, and with the support of the European Commission's Seventh Framework Program, we were able to determine that our PLX cells can become an important treatment for various cardiac indications and we look forward to quickly moving from these initial studies towards human trials."

Read more about the study at DDDMag.com. 

Compassionate Use of Pluristem's PLX Cells Saves the Life of a Child After Bone Marrow Transplantation Failure (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. 

The Company has announced that "a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating is now experiencing a reversal of her condition with a significant increase in her red cells, white cells and platelets following the intramuscular injection of the company's PLacental eXpanded (PLX) cells."

Patients with Aplastic bone marrow have no blood-forming hematopoietic stem cells in their bone marrow.

Professor Reuven Or, Director of Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center at Hadassah Medical Center and the child's physician, explained, 

"With her body rejecting all possible treatment -- and with no other options -- we finally turned to Pluristem's PLX cells, which literally saved her life. The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow."

Zami Aberman, Chairman and CEO of Pluristem, commented,

"Pluristem is extremely happy that our PLX cells have helped this little girl. Remarkably, these beneficial effects were seen in the patient after our PLX cells were administered intramuscularly and correlates with the positive effects on the bone marrow when we administered our PLX cells intramuscularly (IM) in animals exposed to toxic levels of radiation. Pluristem now has several data points to indicate that our PLX cells may work for systemic diseases when given locally, away from the target organ, and without a need to give cells intravenously."

In February 2012, Pluristem announced the results of animal studies which suggest that "PLX cells can be potentially effective in treating the life threatening hematopoietic complications associated with Acute Radiation Syndrome (ARS)." In the experiments in question, animals were given PLX cells IM up to 24 hours post irradiation. They demonstrated a recovery of their red cells, white cells, platelets and bone marrow to almost normal levels. This announcement, along with his patient's significant deterioration following two bone marrow transplants, that led Professor Reuven Or to contact Pluristem about the possible compassionate use of PLX cells to treat his young patient.

Pluristem recently received U.S. FDA Clearance "to begin a Phase II clinical trial using the company's proprietary PLX-PAD cell product candidate intramuscularly for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). In April, the Company was awarded a $3.1 Million grant by the Israeli Government, which will be used to help fund R&D and clinical trials."

This news could have positive implications for Athersys who is planning to pursue a phase II registrational style trial in GvHD prevent. There are also implications for Osiris. 

Read the full press release at Yahoo Finance. 

Pluristem Awarded a $3.1 Million Grant by Israeli Government (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. 

The company announced that its wholly owned subsidiary, Pluristem Ltd., has been approved for a 11.8 million New Israeli Shekels (approximately $3.1 million) grant from the Office of the Chief Scientist (OCS) within the Israeli Ministry of Industry, Trade and Labor. The grant, once received, "will be used to cover R&D expenses for the period March to December 2012. According to the OCS grant terms, Pluristem Ltd. is required to pay royalties in the rate of 3% - 5% on sales of products and services derived from technology developed using this and other OCS grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required."

The OCS was empowered by the Law for the Encouragement of Industrial Research & Development -- 1984. It "oversees all Government sponsored support of R&D in the Israeli hi-tech and bio-tech industries. This broad-spectrum support stimulates the development of innovative state-of-the-art technologies, enhances the competitive power of the industry in the global hi-tech market, creates employment opportunities and assists in improving Israel's balance of payments."

Chairman and CEO of Pluristem Zami Aberman stated,

"We are pleased Pluristem's PLX cells were recognized as an innovative state-of-the-art technology with a potential to create long term sustainable competitive advantage in the cell therapy industry. This grant will assist the company in enhancing its R&D plans and clinical trials, helping us bring the PLX product candidates to market for the treatment of millions of patients around the world." 

Read more at Yahoo Finance. 

Pluristem Receives U.S. FDA Clearance for Phase II Clinical Trial in Intermitten Claudication ($PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. 

Pluristem Theapeutics announced that the FDA has approved the commencement of Phase II clinical trials of PLX-PAD cell product candidate for the treatment of a form of peripheral artery disease, Intermittent Claudication (IC).  This trial will investigate the safety and effectiveness of of PLX-PAD cells versus placebo.  

Zami Aberman, Chairman and CEO of Pluristem, commented,

"We are excited to receive the world's FDA first clearance for an Intermittent Claudication clinical trial using allogeneic cell therapy as a potential preventive treatment for IC. We believe that our approach of repeatable intramuscular injections will potentially enable us to boost the healing process of our patients. In this trial, we will take benefit of our 'off-the-shelf' PLX properties achieved by our three dimensional (3D) proprietary technology platform for efficient, controlled, mass production of cell therapy product candidates, for the treatment of millions of IC patients around the world."

Read the full press release here.  

DD Education: Which Cell Therapy companies present the best value? Part 2

We developed an analysis using public filings and annualizing the most recent quarters as of 12/31/11. As such, the accuracy is subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

We conclude that ex leaders Dendreon and MesoBlast make the space very inexpensive. The sample below represents just over $500 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials. Recent data peaks from the Cardiology space suggests that Baxter (BAX) and their CD34 cell type may be very viable. NeoStem has a very similar approach. The retrenchment in MesoBlast shares since that company presented data at AHA in November is of concern. Cytori, Aastrom, Athersys all have active programs in cardiology while Athersys lead program is partnered with Pfizer for Ulcerative Colitis and Aastrom is entering a Phase 3 trial in CLI.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash: (enterprise value). In all fairness here, we know that NeoStem with $20-$30 million in value from their China generic company, could be the cheapest name and others are / will raise capital but ex China, Athersys is the “cheapest name”.

Looking at R&D spending: IMUC, Prima and NeoStem are among the most efficient but in fairness one must adjust for the fact that Aastrom is embarking on a pivotal trial versus Prima just starting their P3 and NeoStem their P2.

Revenues: Here we have excluded NeoStem’s $65 million from China which means PCT (Cell Therapy CMO) is running at close to $10 million in annual revenues (currently).

Which Cell Therapy companies present the best value?

In the wake of a robust season of financings, and low valuations we revisit the basic questions in the cell therapy space, updating our tables for year end reported financials. Our numbers are forward looking and subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

Dendreon and MesoBlast remain the market leaders, but the best values by far are in the micro-cap space with names like Aastrom and PluriStem funded with strong balance sheets.

The sample below represents just over $875 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks: 

By Price ($), Osiris , MesoBlast and Dendreon are the highest $ price:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash (enterprise value):

Looking at R&D spend gives us an idea of who is spending what on clinical programs: