Enzolytics Inc (ENZC)

[foxi]

Thanks for collecting those!

Toxicology studies are ongoing and near completion in the Company’s partnering California lab. The results of these tests will be reported as they are completed.

This seems like good news. I hope they hold true to their promise of prompt reporting.

From https://enzolytics.com it looks like their California partner was previously testing mAbs, so I'm a little confused about the sentence above being included in the paragraph about ITV-1.

Partners in Executing Our Technologies
[...]
California National Primate Research Center
Macaque trials of Monoclonal Antibodies

Simultaneously, the ITV-1 therapeutic is proceeding through the necessary multi-stage production process in the Company’s partnering lab in Europe. The current ongoing production of ITV-1 will be used in clinical trials conducted under the EMA guidelines. Early production of ITV-1 will be submitted to health care entities in Africa, where testing and use of the therapeutics are expected to be made possible before EMA approval.

So Africa hasn't even started yet! From the January interview, ENZC was "on track" for "introducing" ITV-1 to Africa in late March early April. This has morphed into "as soon as possible" in today's PR. No explanation for the months of delay is given in this paragraph.

Enzolytics IPF Immune will be available in numerous sales outlets throughout the U.S. Delays in producing sufficient quantiles for the market are being addressed. These delays have provided time for increasing production capability to meet demand. The company’s market research has indicated significant demand for IPF Immune.

This doesn't even begin to address shareholder concerns regarding the "delays". It implies they did the "launch" without running basic numbers for minimum production capability. We also have zero transparency into demand, or what was done for "increasing production capability" to meet it.

Regarding marketing, the Company has engaged a marketing specialty firm that will use "computer analytics" to target individuals who are specifically searching for a nutrition supplement with the properties of IPF Immune. Such focus will greatly increase sales of this new product while reducing advertising costs.

But they had no advertising costs? And they couldn't even produce enough IPF Immune to meet demand?

Also, what happened to NPI?

Once produced, the monoclonal antibodies are tested for binding and neutralizing activity. These characteristics are confirmed by the Company's partnering laboratories, Genscript Labs, and the University of Strasbourg, France. After confirming antibody activity, the Company's CDMO partner Samsung Biologics produces recombinant antibodies in their proprietary, FDA-approved stable CHO cell line suitable for Clinical Application.

This sounds like a robust process with reputable partners. They should push this forward as much as they can.

The plans are in place to proceed with animal studies to demonstrate the in-vivo efficacy of the monoclonal antibodies in partnership with European partners.

Plans!

The Company is producing fully human monoclonal antibodies against these claimed [HIV] sites. The International Patent Office has now confirmed these discoveries to be novel and inventive, capable of being patented and claimed exclusively for a 20-year term in every member country under the Patent Cooperation Treat in which the Company pursues these claims.

Due to the novel nature of the Company’s discoveries, the Company fully expects the same favorable results in the PCT Patent Office for its pending applications covering epitopes (binding sites) on [a bunch of other viruses.]

This seems like good news. It's hard to wait but having international patents on mAbs for all these viruses would be desirable from a shareholders' standpoint.

The Company believes that its extensive patent portfolio will provide a return on investment through partnering or licensing technology covered by multiple international patents.

Licensing their tech is maybe their best shot at revenue. That'd certainly be an angle to pursue and may open doors for further partnerships if the licensed products are successful.

Given the large number of therapeutics being advanced by Enzolytics, the Company is focused on raising the necessary funds for the production and sale in the U.S. and abroad of IPF Immune, final development of its anti-HIV ITV-1 therapeutic, accelerating the development of multiple monoclonal antibodies for human therapy, and production of animal monoclonal antibodies. The Company’s audit is being finalized, and the Company fully expects to be able to acquire the funding necessary to complete its multiple programs.

Okay, lots to unpack here. First, they still need to raise the funds for production and sale of IPF Immune. Without funding, all the "plans" for Africa and clinical trials would also be stuck since IPF Immune still hasn't finished development. The audit is still being finalized (so no progress there?). And the company desires an investing partner or revenue source but has been unable to find any cashflow sufficient to drive further operations so far in 2022.

I don't mean to be too harsh, and I want to see ENZC succeed. It's unfortunate the company didn't shoot straight about its challenges and setbacks during the year so far. Omitting the bad news until the last moment, and padding the good news in the meantime, sends the impression of deceit. Maybe as management builds experience, communication will get stronger. ENZC has a great portfolio of technologies, and this could carry them far, but communication and reputation are critical components to success.