CEL-SCI: No Rush Here.
This article provides a quarterly update on CEL-SCI ( NYSE:CVM ) as it pursues its ponderous path towards a commercial pulse. As I will discuss this is not a pretty picture.
CEL-SCI is a one trick pony focused on development of its Multikine cancer therapy.
CEL-SCI's corporate philosophy is spelled out on its website. It is borne of the conventional belief that the body's immune system provides the most effective mechanism for curing disease. CEL-SCI departs from convention in its preferred therapeutic mechanism for applying this insight.
CEL-SCI's unique approach is embodied in its Multikine therapy. Multikine is a cocktail of selected cytokines administered to patients by injection prior to more intrusive treatments. This approach assists the body's immune system in identifying and treating cancer while it is best able to do so.
CEL-SCI's presentation slide describes it in greater detail as shown below:
CEL-SCI's 10/2021 Corporate Presentation (CEL-SCI.com)
As reflected by CEL-SCI's skeletal pipeline beyond Multikine, Cel-Sci doesn't have much going.
Unfortunately CEL-SCI has been pursuing this vision without attention to time.
CEL-SCI was founded and went public in 1983. It has been working on its Multikine therapy ever since. Its CEO and current guiding light, Geert Kersten, is an old-timer with the company.
Its 10-K for year 2001 describes its approval given in 1990 to begin a study of Multikine in treatment of unresectable head and neck cancer. Fast forward to 2021 and its latest corporate presentation describes its latest Multikine head and neck cancer study as follows:
Sci's 10/2021 Corporate Presentation (Cel-Sci.com)
While CEL-SCI has been fiddling with its Multikine development, its meagre patent estate has been burning. According to its latest 10-K (p. 10), its US Multikine patent expires in 2023. Its patents in Germany and elsewhere around the world expire over the next few years.
It does have a patent issued in 2022 protecting Multikine's method of action. CEL-SCI also maintains certain of its manufacturing processes as trade secrets. If Multikine were ever to attract competitive interest, it seems certain that competitors would quickly focus on how they might circumvent Cel-Sci's Multikine intellectual property.
At this point, that would be good news. It would mean someone thought Multikine had value worth pirating.
CEL-SCI's financial resources are limited.
CEL-SCI's accumulated deficit (p. 20) of $418 million over 35+ years without any product revenue suggests a corporate expense profile which has not strayed far afield from its focus. Indeed, as noted, a look at its pipeline confirms that it has pretty much stuck to its Multikine knitting.
For some strange reason unknown to me, CEL-SCI never bothers with quarterly earnings calls. Instead it provides an earnings press release. Its most recent such release (as of 02/22/2022) covers fiscal Q1, 2022. It is light on financial details, its primary such information being that it had a net loss for the quarter of $8.0 million and:
As of December 31, 2021, CEL-SCI had $37.1 million in cash and cash equivalents.
This implies a cash runway of a year+.
CEL-SCI will likely need significant cash raises before it generates any product revenues.
CEL-SCI's cupboard of catalysts is focused squarely on its Multikine therapy. We lack any guidance from the give and take of an earnings call Q&A session. As such, CEL-SCI pretty much leaves its Multikine development timeline open to speculation.
Its latest available presentation slide 18 provides the steps in the process for approval planned as follows:
We have identified, and validated with the study data, a way to determine what patient is supposed to receive radiotherapy as opposed to radiochemotherapy following surgery File data package for pre-Biologics License Application (BLA) meeting with FDA Submit data for peer review in top scientific journals Finalize clinical report and submit to FDA.
This last step must occur before we can consider that Cel-Sci is ready to play money ball. When will this occur? CEL-SCI offers nary a peep on this key issue. Given the stately haste with which it has operated over the last decades one might well conjecture, "no time soon".
CEL-SCI has long been laboring on its Multikine manufacturing facility with recent announced addition.
In CEL-SCI's 2001 10-K, it touted its plans to build a major manufacturing program to produce anticipated Multikine demand. The program started with a pilot scale facility. A 2009 Seeking Alpha article, "Cel-Sci Thrives with New Manufacturing Facility" picked up on the project. It characterized it as "a cornerstone to the future financial success of the company".
In a recent (10/2021) publicity release, CEL-SCI announced a completion of a doubling of the size of its facility to meet anticipated Multikine demand. It also advised it was hiring and training additional personnel to operate the facility.
Its previously mentioned 10/2021 presentation included the following slide with an updated facility description:
Sci's 10/2021 Corporate Presentation (Cel-Sci.com)
Wow. CEL-SCI is getting ready for its big dance; one question, when is it? When is CEL-SCI going to file its BLA for approval of Multikine?
Conclusion.
CEL-SCI is a battleground stock. I discussed its upcoming challenges in some detail in 08/2021's "CEL-SCI's Tough Road Ahead". At the time I rated CEL-SCI charitably as a "hold".
Given the lack of any discernible progress or guidance on when to expect a filing for Multikine with the FDA, I now rate it charitably as a "sell", rather than a "strong sell" as rated by Seeking Alpha's Quant Ratings.
For investors seeking a more sanguine outlook check out No Guess Trading's 07 and 08/2021 "strong buy" articles.