Enzolytics Inc (ENZC)

[foxi]

It might take that long,

The Company’s ITV-1 anti-HIV therapeutic is in production and the Company is proceeding with steps to advance it through approval under the European Medicines Act (EMA). 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. 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.

(Page 16)

ITV-1 clinical trials haven't started yet but may not be far in the future.

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.

(Page 17)

The IPF "launch" seems a bust. Unless I missed it, there's zero revenue from it in Q2 according to the 9/8 filing. So I guess they "launched" it but never produced or sold any.

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.

(Page 18)

mAbs of all types appear to be still in research and development phase.

As to each of these entities and those with whom the Company currently works on an ongoing basis, the Company has entered into NDAs (Nondisclosure Agreements) necessary to preserve and protect the Company plans and intellectual property being discussed and exchanged between the parties. These contractual restrictions are critical for the Company and its partners. Maintenance of strict confidentiality is essential to preserving intellectual property rights (patent rights) which are now being sought and will be sought in the future. Premature disclosure of information can bar the right to seek patent protection at a later date. The Company is not able to share specific details regarding arrangements regarding these NDAs.

(Page 19)

NDAs with most or all partners. News may be more scarce, with sudden reveals.

They're going for international patents (PCT) and those can take 30 months or more to execute in member countries.

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.

(Page 21)

Possible cashflow problem. The filing from 9/8 shows only $515k in cash & equivalents.


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