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Pluristem: a clinical-stage regenerative medicine company with FDA approved manufacturing process

Company: Pluristem Therapeutics Inc.

Ticker: NASDAQ:PSTI Market Cap: $150M (3/31/21)


PSTI is a clinical-stage regenerative medicine company with FDA approved manufacturing process and Ark Invest owns 9% of the company

The stock covers investment themes like regenerative medicines, longevity, stem cells, genomics, allogeneic cell therapies & even space related topics. On top of that a SPAC is part of the story but not in the way that you might think ;)


Structure:

  • Introduction & background

  • Why is it different this time?

  • What makes PSTI’s approach to cell therapy special?

  • Do they have the ability to scale & apply Wright’s Law?

  • Are we ready for prime time?

  • Financials

  • Management

  • Why did the price drop in Dec 2020 & why am I not worried?

  • Risks

  • Conclusion

Introduction & background


“Science fiction is now science”

Being a huge comics fan throughout my teenage years, Wolverine always was one of my favorite characters.


He has a healing factor this means if he would lose a hand, it would grow back. Deadpool has similar powers. Companies that are involved in stem cell research are making this healing factor a reality now! PSTI is such a company and one of their products is called PLX-PAD

“Placental eXpanded (PLX), -PAD cells are mesenchymal-like stromal cell products, isolated for human placenta and expanded ex-vivo. The cells exhibit regenerative potential due to their capacity to release factors in response to chemical distress signals from tissues that have been damaged by muscle trauma or inflammation. These therapeutic factors trigger the body’s own repair mechanisms and stimulate tissue renewal, differentiation and modulation of immune-mediated inflammation . PLX-PAD cells also modulate the immune system, which plays a central role in the body’s response to injuries.” source

The company is not new, it was founded in 2001 by Shai Meretzki of the Technion (remember this one, I will come back on it), who made use of a stem cell patent. In 2003, the SPAC (yes they even existed then;) ) A1 Software merged with Pluristem & changed its ticker to PSTI. I think these transactions were called reverse mergers back then. A lot of Biotech companies started mid 90s/early 2000’s but as Cathie Wood explains in a lot of her interviews and "in the know" videos, at that time the secular tailwinds & convergence of the technology platforms were missing. PSTI is a position in Ark-invest's Genomic Revolution ETF ARKG.





PSTI reached a high of 4,240 $ in 2003. Though they had a couple of back & forth stock splits since then and I don’t know how many capital raises they did. Tough to determine how the 4K price compares to today’s price in terms of valuation. Relative to what PSTI can achieve now, current price (market cap of <250M) is cheap (in my opinion) and as Cathie said in a recent interview “Apple has a market cap of 2T and they are not healing people”.


Why is it different this time?

Their vision statement highlights a few key points that can help us assess if this is a potential +10 bagger: “Our vision is to leverage our advanced technology and our position as a global leader in cell therapy to develop, manufacture and market highly effective cell products that will heal patients around the world.”

I highlighted some of the keywords that stood out to me. This is not a company that is only in research for research’s sake but they are ready to start the engine & really go for mass commercialization of their cell products, as they have built the manufacturing capabilities.

In addition, “Cell & Gene Therapy: Generation 2” is #15 of Ark big ideas 2021

On p108 find input on Allogeneic Cell Therapies. In the context of the slide the focus is on Oncology trials but the concept of autologous vs allogeneic still applies for cell therapies in general.



Why is allogeneic such a big idea? In allogeneic cell therapies you just inject a cell that was built off the shelf vs built specifically of the patient itself. The benefits are listed on the slide. Shout outs to Ark invest for this great comparison. It made me go down the rabbit hole and I found some more companies that are focused on allogeneic cell therapies (LCTX, AGE & IBRX).


What makes PSTI’s approach to cell therapy special?

Rather than harvesting cells from the human embryo, Pluristem takes its cells from the human placentas, following a full term birth of a child, thereby avoiding the need to destroy live embryos. No blood or tissue matching is required. They hold 120 granted patents globally. Last but not least, collaborations with highly decorated organizations and even NASA! More on that later.





Do they have the ability to scale & apply Wright’s Law?

As showcased above they have an industrial scale in-house GMP manufacturing facility and can produce high quality cell products at a commercial scale. Their manufacturing process is already approved by key regulators. Their fully vertical solution is even including advanced cold chain logistical capabilities. It seems to me that they can manufacture cells at high scale and are willing to ride down the cost curve.


Are we ready for prime time?

They are at the Inflection point from clinical development to mass commercialization. Their trial covering the indication “muscle regeneration following hip structure” is already in phase 3. We can expect quite a lot of catalysts in 2021 as readout from 3 studies are expected. In addition, they uplisted recently to NASDAQ global market.





Financials

They closed a non-dilutive financing agreement with the European Investment Bank for a total amount of 50M€ and recently did a capital raise. This puts them in a solid financial position to progress the relevant trials & operations for 3 years!


Management

Current CEO Yaky Yanay was CFO before and had been with the company more than 10 years. However, I want two highlight 2 other people.


Zami Aberman is Executive Chairman "Mr. Aberman's vision to use the maternal portion of the placenta as a cell source for Pluristem’s products, combined with Pluristem's 3D culturing technology, led to the development of the Company's unique therapies. In 2013 the World Stem Cells Regenerative Medicine Congress ranked Mr. Aberman as one of the 50 most influential people in the stem cells space."

Racheli Ofir - VP Research & IP Heads the research of the cell's efficacy and safety as well as their mechanism of action by using molecular methods and animal models. She earned her Ph.D. from the Technion, Israel institute of technology, and did her postdoctoral fellowship at the Technion in molecular embryology, investigating genes involved in early development of vertebrates' nervous system. She has extensive research experience in molecular cell biology, embryology and cytogenetics as well as broad professional experience in the field of human cell therapy.

Remember “The Technion”? That is where all this started. Technion – Israel Institute of Technology is a public research university in Haifa, Israel. It's the oldest university in the country. The Technion is ranked as the top university in both Israel and the Middle East, and in the top 100 universities in the world in the Academic Ranking of World Universities.

Racheli also leads the CRISPR IL-consortium pharma working group. The collaboration will enable Pluristem to develop cutting edge genome editing solutions relying on its PLX platform.

It even gets better as Racheli leads the collaboration (announced 2019) between the company and NASA’s Ames Research Center to evaluate the potential of Pluristem’s PLX cell therapies in preventing and treating medical conditions caused during space missions. project “Therapeutic Stromal Cells for Health in Space”


Ark-invest recently launched their space ETF called ARKX. Could PSTI be a contender for ARKX? Spending longer timeframes in no/low gravity is detrimental to human muscle fiber so PLX-PAD could add value for space programs. However, this is just a sidenote. It is not important for me, if PSTI is added to ARKX or not.


Why did the price drop in Dec 2020 & why am I not worried?

On Dec 8th the share price dropped from $11.46 to $5.93 because of PSTIs decision to end a trial. This lead to a market overreaction (in my opinion).


“Pluristem decided to terminate the CLI study to focus on different therapeutic areas in its pipeline and expects three clinical readouts during calendar year 2021”


The reason for this was not that PLX-PAD did not work. The study design was not optimal and they decided to move resources to other studies.


“The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint.“


The market overreacted, when in fact the key point was that “PLX-PAD was well tolerated, and no safety concerns were raised”. Ark invest used the chance to buy more shares. In fact they increased their # of shares by 44% 2.626M to 3.793M. Considering they bought also the weeks before regularly. As followers of Cathies Ark will know, Ark recently sold some shares. However, I think that has more to do with portfolio management and the recent (and ongoing) correction in the markets and how Ark trades in that time (Cathie explained their approach in recengt "in the know" videos). Looking at below graph, you will see that their ownership is still higher than before the trial termination in Dec 2020. In addition, the weight ranking in ARKG is constant when looking at the Cathies Ark weight ranking.





Risks

PSTI shows the characteristics of similar biotech stocks as they can be very volatile and not for the faint of heart. In general, I would not recommend investing in PSTI or in biotech, if volatility (to the downside) worries you. Additional risk factors


  • Risk of trials having unfavorable results

  • FDA approval timeframe prolonged

  • Dilution as part of additional capital raise activities


Conclusion


  • PSTI has multiple trials that are ongoing

  • PLX-PAD is also being studied for Orthopedic use, in the context of hip fractures.

  • Their manufacturing facility, which can manufacture large quantities of their PLX cells in a cost-effective, reproducible and consistent way, has been approved by the FDA, the EU, South Korean & Israeli regulatory agencies.

  • With genomic stocks there are times of overreaction & that is usually the best time to get in (in my opinion). I remember vividly great stocks like PACB, NVTA, TWST etc were really cheap in 2020. Judging from the DD I have done on PSTI, I am fairly confident that they will perform very well longterm and not stay a <250M $ company.


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Additional sources:

Company presentation

December presentation & Webcast Link


Disclaimer: This blog post is purely my personal opinion and is not financial advice. Please do your own research before taking investment decisions. I am long PSTI.