E Orgenesis' Leveraged Approach To Lower The Cost Of Cell And Gene Therapies

Orgenesis (ORGS) is an innovative biotech company in the CGT (Cell & Gene Therapy) space. It has a multi-faceted strategy combining therapeutics, technologies, processes, and systems via a network of collaborative partners, and research institutes, and hospitals around the world in order to provide life-changing treatments to large numbers of patients at reduced costs at the point-of-care. From the 10-Q:

The Platform consists of: (A) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific knowhow; (B) POCare Technologies, a suite of proprietary and in-licensed technologies which are engineered to create customized processing systems for affordable point of care therapies; and (C) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care.

The CGT market is of course in the first innings of a secular expansion, from the company IR presentation:

The problem with many of these therapies is that they are complex and terribly expensive, from the company IR presentation: 

It's the company's mission to reduce these costs and make more therapies available for more patients. One way they're doing that is by specializing in autologous CGT therapies, that is, the cells are harvested from the patients themselves, from the company IR presentation:

But, according to the company website:

Autologous therapies are produced from a patient’s own cells instead of mass-cultivated donor cells. This is a substantial segment of the cell and gene therapy market. These therapies are derived from a treated patient and manufactured through a rigorous, defined protocol before re-administration. As a result, this involves a set of highly complex supply, logistics, and orchestration chains. For patients and healthcare providers alike, the complexity of the supply chains increases risk. In addition, current centralized manufacturing processes significantly contribute to these therapies’ high price tags.

The company's POCare platform is their solution for these problems, from the company IR presentation: 

That POCare platform consists of three parts, from the company IR presentation:  

One might wonder how producing at the point of care delivers "better outcomes with a drastically lower cost" as the slide above argues. The main plank of that is in the POCare Technologies, a suite of proprietary and in-licensed technologies that are engineered to create customized processing systems for affordable point of care therapies which they are bringing to their partners.

The company has a systematic three-step methodology for developing POCare therapies:

Central to this are OMPULs (Orgenesis Mobile Processing Units & Labs) which are still in development, but here is an overview:

Here is some further meat on that, from the 10-Q:

The Company is committed to the validation, adoption and development of systems, technologies and processes for mobile processing unit and labs (“OMPUL”). OMPULs are intended to be used and/or distributed through Company’s point of care network of partners, collaborators and joint ventures for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of potential or approved cell or gene therapy products in a safe, reliable and cost-effective manner. This provides an industrial solution for any clinical institution in the world to provide more therapies at the point of care.

There are a number of advantages that these OMPULs bring (company website):

  • Lower required grade of clean room, simplifying facility management requirements
  • Enabling multi-batch processing per clean room, requiring reduced technical staffing
  • Localized processing eliminates many logistical difficulties associated with traditional centralized manufacturing and transport
  • Faster turnaround, increased safety, and improved QC (Quality Control) management on-site

Before we go to specific therapies, we have to stress that this is a collaborative approach, relying on networked expertise, the company's POCare network:

There is a range of benefits for all participants (from the company website):

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Alpha Stockman 1 month ago Member's comment

Which companies directly compete with $ORGS?

Shareholders Unite 1 month ago Author's comment

Well, anything in the cell & gene therapy space, in theory, but it really depends on the therapy in question, and even that might not be a problem because Orgenesis argues they are doing things cheaper.

Alexa Graham 1 month ago Member's comment

Very interesting, thanks. I've heard about this company, but haven't been able to find much about them.

Shareholders Unite 1 month ago Author's comment

My pleasure Alexa. It's a pretty complex company, perhaps it's more like a little network, as it happens.