Enzolytics Inc (ENZC)

[foxi]

ENZC has been disclosing that they have partnerships with companies and universities, are under NDA(s), that drugs are being produced for trials, and that various trials are/were underway. Although the company's been frustratingly vague, are those disclosures enough to cover Pink sheet material events reportability?

I do think they may be holding off on going SEC reporting to avoid more stringent disclosure requirements surrounding material events. Avoiding uplist may be good or bad, since they could better obfuscate both progress and setbacks by staying Pink.

For ITV-1, we know Danhson was supposed to be making ITV-1 for trials by Clinic Design to get EMA approval, then Scendea was to assist in obtaining FDA approval once EMA approval was granted. (source)

For mAbs,

The Company's primary anti-HIV monoclonal antibody has been produced and successfully tested in vitro against multiple strains of the virus where it shows complete efficacy. The recombinant form of the parent antibody (necessary for patient therapy) has been successfully produced for the Company by Samsung Biologics. This recombinant antibody is currently undergoing efficacy testing in Europe. (source)

If we can't find a trial filing, can we conclude it doesn't exist? Maybe we're not looking in the right places, or searching with the right terms?

If ENZC is going for EMA approval before FDA approval, they might file for a Clinical Trial Authorisation (CTA) with EMA rather than an Investigational New Drug (IND) with FDA. (Someone who knows, please weigh in.)

The CTA might be filed under a partner or sponsoring company's name.

The drug name might also be obfuscated.


For example, we might run across something like this:

https://clinicaltrials.gov/ct2/show/NCT05505448

It's an ongoing Phase 1 study of a covid mAb drug, code named "REGN14284" and never tested on humans prior (according to the volunteer letter), filed in August 2022 and carried out at UZ Leuven in Belgium on behalf of Regeneron Pharmaceuticals. The filing specifically says it does not study a U.S. FDA-regulated Drug or Device Product.

Long shot it's ENZC's mAbs, but good luck finding any info on REGN14284 to confirm or deny.