From: Joe Gantoss Article.
Pluristem Financials
Pluristem reported $22.5 million in cash last quarter and has approximately $10 million in future Payments from approved Grants, which provides the company with sufficient resources to fund research, development and operations first quarter of fiscal year 2020. On the top of the cash in hands, Pluristem is targeting contract with the US Government (NIH and or BARDA) with the ARS (Acute Radiation Syndrome) drug in 2019, the stockpile order may inject $30 to $40 million to the company and help them to maintain operation towards the end of 2021.
Lately Pluristem entered into license agreement with “Thermo Fisher Scientific” and “Chart”, both will turn into another source generating royalties and revenue in the near future. The first agreement was a strategic collaboration with Thermo Fisher Scientific to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain, while the license agreement with a subsidiary of Chart Industries regarding Pluristem’s thawing device for cell-based therapies. Per the terms of the agreement, Chart obtains the exclusive rights to manufacture and market the thawing device in all territories worldwide, excluding China, with Pluristem receiving royalties from sales of the product and supply of an agreed number of devices.
Moreover; as I mentioned before, the FDA CLI EAP (Expanded Access Program) can start generating revenue starting this month, charging around $30,000 per patient. An initial 100 Rutherford-5 CLI patients who are ineligible for inclusion under Pluristem’s ongoing Phase 3 study protocol, and whose condition is life-threatening, will be enrolled in the EAP. In total these 3 programs can generate several millions of dollars into the year 2019.
Conclusion
If we consider only one indication from Pluristem pipeline, the CLI alone can generate a multi-billion Dollar revenue within first 2 years post approval, which show how underestimated the company is these days, trading under-the-radar with market-cap of only ~$120 million. By applying only 15% of the CLI patients with R-5 in the US, give us around 160,000 patients, even if we consider the lowest pricing level of $29,000 (which is very low and most likely will be set around mid-level $50,000) this give us around $4.64 billion of revenue in the U.S. and equivalent amount in the E.U.
The EAP in the U.S. show FDA’s comfort with the safety profile of PLX-PAD, and the confidence of its potential use in treating CLI patients who have no other treatment options, so we will give 60% chance of study success and reaching the market in the EU by 2020 and in the US by 2021. On the other side, like any other clinical trial there is a risk of failing to reach a statistically significant results vs. placebo, and in this case the risk of a significant drop in the company valuation would be expected.
