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Except for the 250K sell just after the bell @.03999. Another T Trade right under best bid? It's been everyday for weeks now. How much Is enough? Until that ends we stay tethered down here around .04. $°ENZC
Whats with all the selling pressure? Hold on and stay awhile. This is bound to go up eventually. $ENZC
You see what Harry did? Took the money for Brenna and bought 2 ships with it. Hope Revs are better than before trade. As for the share buy back? Who knows? He should be mashing massive market buys right now. You go Harry! $IMPP
-- in focus. How about start buying? Slowly all falling into place. $enzc!
News out- Read all about it!
September 6, 2023 - 8:45 am
Start date is expected by the end of 2023 / beginning of 2024. VIRO also offers an update on Diabetic trials and Sagaliam transaction.
ALLEN, TX / ACCESSWIRE / September 6, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).
Virogentics, Inc. ("VIRO"), a wholly owned subsidiary of Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, announced today that based on the Bulgarian population of HIV-infected individuals that the sample size for the ITV-1 clinical trials will be 60 individuals.
R&D Services Ltd. ("R&D"), under the leadership of Aneliya Vidinlieva, Manager Clinical Trials, assisted by Dr. Ivaylo Tsonev, Chief Medical Officer of Desing and three consultants assigned by the University of Pharmacology, will be performing the clinical trials. R&D and VIRO expect the clinical trials to begin in late 2023 or early 2024.
With locations across Bulgaria, where the Clinical Trials will be conducted, R&D services will manage all the administration of the Clinical Trials of ITV-1 conducted in public, municipal, and private healthcare institutions. R&D is certified to ISO 9001:2015, ISO 27001:2013, and ISO 14001:2015 quality assurance standards for services provided.
R&D Services Ltd.'s general responsibilities include but are not limited to the following:
Improving the quality of the collected data during the clinical trials.
Building up a trial site at each healthcare institution and providing all the necessary equipment for conducting clinical trials and premises for proper document and study drugs storage, in compliance with the Good Documentation Practice, Good Clinical Practice, and Good Manufacturing Practice.
Ensuring protocol compliance, compliance with the International Conference on Harmonisation - Good Clinical Practice guideline, Bulgarian legislation and specific requirements of the Sponsor/CRO.
Providing the necessary documents for the initial study submission.
Prescreening of eligible patients during the initial review/approval period so that a maximum number of patients can be enrolled in the relevant time period.
Redirecting eligible patients from trial sites that do not participate in the trial to sites that are approved; building a referral network of physicians to support the study enrollment.
Quality checking all the needed documentation concerning the proper conduct of a clinical study (eCRF, temperature logs, subject logs, study drug accountability logs).
Reporting any adverse events to the Sponsor/CRO.
Ensuring document access for audits on behalf of the Sponsor/CRO, independent auditor, and regulatory authorities.
In addition, the trials being conducted by R&D will include a review by an immunologist to evaluate any correlation of patient outcomes with a different origin of immune deficiency using cell examination.
The Company's therapeutic developments will include participation by many established pharm entities, including the following. VETPROM AD, a division of the French company Danhson, currently headed by Stanislav Stoev, Executive Director,represents over 65 years of continuous operations in the Bulgarian economy and is one of the largest pharmaceutical manufacturers of medicinal products (for human and veterinary use), food supplements and cosmetics in Bulgaria. VETPROM manufactures products under its brand name, as well as for third parties under contract manufacture agreements operating under accepted ISO 9001:2008 System for quality of management and the integrated system for Good Manufacturing Practice, under requirements of Volume 4, Good manufacturing practice (GMP) Guidelines.
The German Cooperative Clinical Grug Research and Development (CCDRD) is a contract research organization for clinical phase I-IV trials and will be performing the pharmacokinetics study on ITV-1 under the guidance and leadership of the CEO Rossen Koytchev, MD, PhD and Petra Kowalski PhD, Director of Business Development. CCDRD was founded in 1990 and has been performing clinical trials for over 30 years. The company is headquartered in Hoppegarten near Berlin, Germany.
The Center of Phytochemistry was set up as a joint project of the Bulgarian Government, UNDP, and UNESCO for scientific and applied research and training of specialists in organic chemistry and chemistry of natural products. The organization was renamed The Institute of Organic Chemistry with Centre of Phytochemistry (IOCCP) and is the leading scientific institution in t organic and bio-organic chemistry field in Bulgaria. VIRO has engaged IOCCP, represented by Prof. DSc Pavlina Dolashka, a member of its organizing committee and scientific committee to perform the biochem analysis of ITV-1 at the Bulgarian Academy of Science.
Documentation and correspondence that is required with the EMA as part of the permitting and application process will be performed for VIRO by Vili Topalova, MD EU QPPV Medical Director of AV Consult Pharm ("AVCP"). AVCP is a consulting company in the fields of Regulatory Affairs, Pharmacovigilance, Medical Devices vigilance, Cosmetovigilance, price and reimbursement and other consultancies for medical treatments. AVCP's expertise is based on years of experience with the Bulgarian Drug Agency (BDA) and the technical expertise of its employees - former experts and employees of the Bulgarian Drug Agency (BDA).
As a result of a delay in delivery of the Toxicity report to the African hospitals, GOMA, PRC, and Panzi Hospital, Bukavu, DRC, the administration of the ITV-1 immunotherapy initial injections into the HIV/AIDS-infected volunteers was delayed. We expect that to commence soon.
Since entering the U.S. Market six months ago, VIRO's growing nutraceutical division has resulted in the exclusive distribution licensing of + Liver Rescue™ in the North American market. This product accelerates the functions of the liver (accelerated emission of alcohol dehydrogenase), thereby reducing the harmful effects of alcohol on the body and the central nervous system. This is a new revolutionary nutritional supplement in the form of a drink, which is currently being marketed in Europe with great success. Coupled with the monthly increasing production and sales of IPF Immune™, the market potential for these products is favorable.
Currently, the Company is pursuing testing IPF Immune as an immunomodulator under EMA guidelines on patients with cirrhosis, as an after-radiation and chemotherapy treatment of cancer patients in an attempt to reduce recovery time from the effects, impact on HIV patients immune system (in addition to the ITV-1 Clinical trials), application for type 2 diabetes patients effect on blood sugar levels and glycosylated Hb (in addition to the clinical trials of ITV-1 as a treatment for type 2 diabetes scheduled for later this year), herpes, COVID, influenza and all diseases where there is an immune system decline - including autoimmune disease. With the potential of both ITV-1 and IPF Immune to participate in the aforementioned markets, capturing 1% of the 2022 autoimmune $104.21 billion market and the $84.56 2023 diabetes market, VIRO could realize over $2 billion in revenue in addition to what it captures in the HIV/AIDS $30.46 billion market where VIRO expects the most significant market penetration.
VIRO has also filed two utility patent applications covering its new developments, one covering the European Union and one for the United States.
"With the quality of our partners and our past success with ITV-1 Clinical trials, we at VIRO are expecting great success in not only the ITV-1 application to HIV but also its application to Diabetes and other areas being pursued," stated Harry Zhabilov, CSO of VIRO.
ENZC has provided SAGA with its draft of the Business Combination Agreement and related documents and is awaiting any edits or comments in anticipation of a final version being circulated for signature by October 31, 2023.
Barry Kostiner, CEO of Sagaliam, commented, "We are continuing to make progress on the consummation of our transaction with Enzolytics. The deep bench of expertise and therapeutic solutions is impressive. In addition to our dedicated scientists, we have an outstanding team of collaborators who support all aspects of the business including regulatory, clinical and manufacturing operations. The goal is to build a pharmaceutical platform company, going beyond one-off therapies, to providing solutions for broad categories of chronic disease."
Enzolytics, Inc. Overview
Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. ITV-1 has also been shown to modulate the immune system.
The Company has proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases which is currently being employed to produce monoclonal antibody therapeutics for treating the CoronaVirus (SARS-CoV-2), HIV-1 and the Feline Leukemia virus. The Company has also identified conserved epitopes on and has plans to produce mAbs targeting many other viruses, including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). The Company has also analyzed epitopes of animal viruses and plans to produce mAbs for treating these animal viruses.
Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.
While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.
Company Contact:
Enzolytics, Inc.
1101 Raintree Circle
Allen, Texas 75013
www.enzolytics.com
SOURCE: Enzolytics, Inc.
View source version on accesswire.com:
https://www.accesswire.com/781111/patient-population-for-the-clinical-trials-of-itv-1-has-been-established-by-the-european-medicines-agency-ema
We are all hoping wishing and dreaming For 3 years now and counting. This like watching paint dry. Developments come and go and we just sit here. Waiting for the deal. $ENZC
Ken has given us no reason to buy for months now. The only real trading is people selling. $WDLF
Endless battle over 1000th of a penny profit. So tired of this. Of all the stocks to flip, sure wouldn't pick this one. $ENZC
So your basically saying we're waiting for the SAGA deal with the dividends for any of us holding ENZC shares to have a chance to make any real money here in the long run. As a new investor I wouldn't know which would be a better buy. SAGA which only trades 1-100 shares a day or ENZC which has been held down in the low pennies for months. Both stocks have gone nowhere really. I question everyday why I continue to torture myself holding this. Basically, I'm just holding a lottery ticket with a 1 in a million chance to win big. I could see this pop and drop again like it did in '21. Only this time I need to sell at the top and not repeat another 2 years of kicking my ass on a daily basis.
Only time will tell. More time. Great. I dont know which will happen first. A nice windfall here or my first social security check. 🤔 $ENZC
They should just announce the deal is done this week then maybe the POS will skyrocket. If they drag this on another month then we keep circling the drain. Deal falls through then game over. Trips are coming. Am I wrong in thinking? $ENZC
8-9 months delay and postpone. I dont get it.
Pathetic. Another hole in the boat. OTCN driving us down again today. Rinse and repeat. Nobody's making any serious coin today. $ENZC
So is OTCN a computer driven algorithm controlling its ask position and trading or is a human behind it? I've been wondering this. There seems to be a ptedictable pattern the way it pops up and disappears on the ask. $ENZC
Until we have a promised liquidity event so this company can make more money. This stock is dead. Period. There is nothing to sugar coat. Been here over 2 years. All the podcasts and promises have just been useless noise. I had no idea it was going to take this long and longer than that. Come on Ken! Make it rain! $WDLF
Forgive me for not knowing. Who is "ENZO"?
Who is still buying , adding and or averaging down? Haven't heard anyone admitting that for a long time. So what is SAGA waiting for getting the "deal" done? Enzolytics getting their act together, trial results, filings or the so called investors actually forking over the $450M? At 3 pennies, can't be too many long term committed bagholders left on this sinking life raft. $ENZC
Ken can talk now right? When is the next pod-excuse, I mean podcast? $WDLF
Just answered my own question. They're back. Must of read my post.
OTCN gone? Haven't seen them for awhile. Must be why we're green. $ENZC
How about the 10Q? Isn't today the deadline? $ENZC
So are the IFP sales going to show up this quarter? Anyone. $ENZC
How come Samsung Bio or Intel can't pony up some funds to help out ENZC? If they think they are on to some big cure etc. I dont understand why ENZC is so hard up for money for trials. Wouldn't people be falling all over themselves to get a piece of it.
1.3M T-Trade Sell EOD someone has been working hard to unload. $ENZC
Don't you need to own $ENZC shares to get SAGA shares? People must not believe the deal will happen. Maybe they are waiting for ENZC to file audited fins. Who knows.
OTCN rides this down like a pole dancer. All our morning gains wiped out. Just another day in $ENZC land.
OMG! He did it. Another offering. Glad I'm out of this.
Imperial Petroleum Inc. Announces Pricing of Approximately $17.0 Million Registered Direct Offering
https://finance.yahoo.com/quote/IMPP?p=IMPP
I take back that $CISS is doing better. I looked again. Blah!
What a train wreck! I'm speechless. Sorry for those that bought around $3.50 thinking this was going to $5 Harry will forever have a curse on this stock. $CISS and $GASS seem to be doing better.
Yet, OTCN is still there. I'd give my left nut to know how many more shares he has. Someones been feeding them. $ENZC
There it is. Going red again on great earnings. Way to go Harry! $IMPP
Nothing but positive events. Makes for good odds for some kind up-rise in PPS. $TOPS$
Made a Doji on the charts. Interpret it as you choose. Up-down up down! (song)$ENZC
It sounds like they are behind like they always are to me. We're 1 week into August already. Shouldn't crap be happening? The deal, Audited fins, picture of a handshake, I'll take anything. But they are showing progress. $ENZC
Let me guess. OTCN is holding this down and keeping us captive. $ENZC
I'd like to have time to reap my rewards for being a 3 year bagholder. $ENZC
To me its sounds like just kick'n the can down the road. Why is it taking so long? $ENZC
I use to brag to my wife about this stock, how great it was going to be. Now I just plead insanity. Consider it lost. Don't count on this for retirement. Tell me I'm wrong. $ENZC
And there's a gut-punch. Just when we thought...... $ENZC
Be nice to breach a nickel for the weekend. Make a statement. "We're Back!" $ENZC