NanoViricides Inc (NNVC) 옵션

"NanoViricides unimpacted by tariffs"
DUH! Tariffs are based on the value of goods. NNVC doesn't make or import anything of value......never has.

I'm sure that you saw this:
"This record is published on behalf of NanoViricides, a paid client of Proactive"

Market cap:
Today...$17M
5 years ago today...$21M
10 years ago today...$118M
15 years ago today...$270M

Looks crazy, but I think it's right.

New Promotional Video: NanoViricides unimpacted by tariffs; sees boost by changes at government agencies

https://www.proactiveinvestors.com/companies/news/1069162/nanoviricides-unimpacted-by-tariffs-sees-boost-by-changes-at-government-agencies.html

Near the end of the written portion of the article:
In light of recent USDA funding initiatives aimed at combating H5N1 avian flu, Vyas said the company is keen to explore applications of NV-387 in that space as well. Currently, NanoViricides is conducting a Phase 2 clinical trial targeting smallpox, following successful Phase 1 results with no reported adverse effects.

First - Monkeypox - not Smallpox
Second - If they actually had started dosing patients for a Phase 2 trial - shouldn't they already have stated this as it would be material to investors or potential investors in the company?
Third - How are they currently funding this, assuming that an actual trial is taking place?

About a week old now - and nothing we haven't heard before - Talking about the Monkey Pox (alleged) trial they are saying they want to do in Africa,...

https://beyondspx.com/article/nanoviricides-nnvc-a-clinical-stage-innovator-pioneering-revolutionary-broad-spectrum-antiviral-treatments

NanoViricides (NNVC): A Clinical-Stage Innovator Pioneering Revolutionary Broad-Spectrum Antiviral Treatments
Published on March 15, 2025 | Ticker: NNVC
NanoViricides, Inc. (NNVC) is a clinical-stage biopharmaceutical company at the forefront of developing innovative nanomedicine-based antiviral therapies. The company's proprietary platform technology enables the creation of highly effective drugs that can combat a wide range of viruses, a feat that has eluded traditional approaches. As NanoViricides progresses its lead drug candidate, NV-387, through the regulatory pipeline, the company is poised to revolutionize the antiviral treatment landscape.

Business Overview and History

NanoViricides was incorporated in Nevada on April 1, 2005, and later redomiciled to Delaware effective May 30, 2023. The company's mission has been to develop a new class of antiviral drugs using its unique nanomedicine technology. Dr. Anil Diwan, the company's co-founder and President, has been the driving force behind the innovative approach, drawing on his extensive experience in polymer chemistry and nanomaterials.

In September 2013, NanoViricides achieved a significant milestone when its common stock began trading on the New York Stock Exchange American under the symbol NNVC. This listing has provided the company with increased visibility and access to capital markets.

Over the years, NanoViricides has developed a broad and long pipeline of drug candidates targeting various viral infections, including Coronaviruses, RSV, Influenza, Herpes Simplex Virus, and more. The company's lead drug candidate, NV-387, is a broad-spectrum antiviral drug that has shown promise in preclinical studies.

One of the key advantages of NanoViricides' approach is its potential to overcome the issue of viral escape, a common challenge faced by traditional antiviral treatments. The company's nanomedicines are designed to target the essential host-side features that viruses require for infection, which are unlikely to change even as the viruses mutate. This feature sets NanoViricides apart from vaccines, antibodies, and small-molecule drugs, which are often rendered ineffective as viruses evolve.

NanoViricides has faced some challenges in its drug development journey, particularly with its COVID-19 program. The lack of available COVID-19 patients prevented the company from completing the planned Phase 1b portion of the clinical trial. However, the company successfully completed the Phase 1a portion, which demonstrated that NV-387 was well-tolerated with no adverse events reported.

A significant asset for NanoViricides is its cGMP-compliant manufacturing facility located at the company's headquarters in Shelton, Connecticut. This facility has enabled the rapid translation of research-scale production to kg-scale cGMP manufacture of drug substances and products. As a result, the company has realized significant cost savings across its drug development programs, enhancing its operational efficiency.

Financial Overview

As a clinical-stage biopharmaceutical company, NanoViricides has yet to generate revenue from product sales. The company's financial performance has been primarily driven by its research and development (R&D) activities, which have been funded through equity financing and non-dilutive grants.

For the fiscal year ended June 30, 2024, NanoViricides reported a net loss of $8.29 million, with no revenue generated. The company's operating expenses were primarily comprised of $5.44 million in R&D costs and $3.08 million in general and administrative expenses.

As of December 31, 2024, NanoViricides had $3.96 million in cash and cash equivalents, along with $7.17 million in net property and equipment assets. The company's total current liabilities stood at $1.18 million, including $866,780 in accounts payable to related parties.

For the most recent quarter ended December 31, 2024, NanoViricides reported a net loss of $2.03 million, with no revenue generated. The decrease in net income was primarily due to increased research and development expenses for the drug candidate NV-387 as the company prepared for Phase II clinical trials.

It's important to note that NanoViricides is a pre-revenue company, and its financial performance is heavily dependent on the successful advancement of its drug pipeline through clinical trials and regulatory approvals. The company's ability to secure additional funding, either through equity financing, grants, or partnerships, will be crucial in supporting its ongoing operations and drug development efforts.

Liquidity and Capital Resources

As of December 31, 2024, NanoViricides had $3.96 million in cash and cash equivalents. The company also has a $3 million line of credit available, which was not drawn upon as of December 31, 2024. During the six-month period ended December 31, 2024, the company used approximately $4.80 million in cash for operating activities, primarily due to costs related to investor outreach activities and additional non-clinical studies to advance NV-387.

The company's current ratio and quick ratio both stand at 3.44, indicating a strong short-term liquidity position. NanoViricides has a debt-to-equity ratio of 0, reflecting its minimal reliance on debt financing.

Management is actively seeking additional financing, including through non-dilutive sources such as government grants and contracts, as well as potential licensing agreements, to fund ongoing operations and further development of its pipeline, particularly the Phase II clinical trials for NV-387. The company believes that achieving key milestones, such as the release of the NV-387 Phase I clinical trial report and the initiation of the Phase II trials, could improve the liquidity of its stock and enhance its ability to raise funds on the public markets.

Drug Pipeline and Clinical Progress

NanoViricides' lead drug candidate, NV-387, is a broad-spectrum antiviral that has demonstrated impressive results in preclinical studies against a variety of viral infections, including Coronaviruses, Influenza, RSV, and Monkeypox/Smallpox.

In December 2023, NV-387 successfully completed a Phase I clinical trial evaluating its safety and tolerability in healthy human subjects. The trial reported no adverse events, and the drug was well-tolerated across all dose levels. This positive outcome paves the way for NanoViricides to advance NV-387 into Phase II clinical trials.

The company is now preparing to initiate a Phase II clinical trial to evaluate the efficacy of NV-387 in the treatment of Monkeypox (MPOX) infection. The trial will be conducted in the Central African region, where the MPOX outbreak has been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization.

In addition to the MPOX indication, NanoViricides is also planning to evaluate NV-387 in a Phase II clinical trial for the treatment of Respiratory Syncytial Virus (RSV) infection, particularly in pediatric patients. RSV is a significant unmet medical need, as there are currently no approved antiviral treatments for this viral infection.

Beyond these immediate clinical priorities, NanoViricides is also exploring the potential of NV-387 in the treatment of Influenza, including the highly pathogenic H5N1 "bird flu" virus, as well as in the management of COVID-19 and Long COVID, subject to the availability of non-dilutive funding.

Another promising drug candidate in NanoViricides' pipeline is NV-HHV-1, formulated as a skin cream for the treatment of Shingles (Varicella-Zoster Virus) and other Herpes Simplex Virus (HSV-1 and HSV-2) infections. NV-HHV-1 has substantially completed IND-enabling studies, and the company plans to pursue clinical trials for this program after the advancement of NV-387.

Competitive Landscape and Potential Market Opportunities

The antiviral drug market is highly competitive, with various pharmaceutical and biotechnology companies developing treatments for a wide range of viral infections. However, NanoViricides' unique approach to targeting the host-side features required for viral infection sets it apart from traditional antiviral therapies.

The company's lead drug candidate, NV-387, addresses several significant market opportunities:

1. Monkeypox/Smallpox: The global public health market for an effective MPOX/Smallpox drug is estimated to be in the billions of dollars, driven by the recognition of Smallpox as a bioterrorism threat and the ongoing MPOX epidemic in Africa.

2. Respiratory Syncytial Virus (RSV): The market size for an effective RSV treatment is estimated to be around $2.6 billion in 2024, growing to $4.3 billion by 2027, as there is currently no approved antiviral drug for this indication.

3. Influenza, including H5N1 "Bird Flu": The Influenza and Bird Flu market is estimated to be around $4.6 billion in 2024, growing to $5.9 billion by 2027. NV-387's broad-spectrum activity against these viruses, including potentially drug-resistant strains, could make it a highly valuable therapeutic option.

4. COVID-19 and Long COVID: While the company has faced challenges in advancing NV-387 for the COVID-19 indication due to the evolving pandemic landscape, the potential to address the unmet need for Long COVID treatments remains an area of interest, subject to the availability of funding.

Risks and Challenges

As a clinical-stage biopharmaceutical company, NanoViricides faces several risks and challenges that investors should be aware of:

1. Regulatory Approval Risk: The successful completion of clinical trials and obtaining regulatory approvals for NV-387 and other drug candidates is critical to the company's success. Delays or setbacks in the regulatory process could significantly impact NanoViricides' timeline and financial performance.

2. Funding and Liquidity Concerns: As a pre-revenue company, NanoViricides relies on equity financing, grants, and potential partnerships to fund its ongoing operations and drug development efforts. The company's ability to secure additional financing will be crucial in supporting its pipeline and maintaining financial solvency.

3. Competition and Technological Advancements: The antiviral drug market is highly competitive, and NanoViricides faces the risk of emerging technologies or competing therapies that may render its products less effective or obsolete.

4. Reliance on Key Personnel: The success of NanoViricides is heavily dependent on the leadership and expertise of its co-founder and President, Dr. Anil Diwan. The loss of key personnel could have a significant impact on the company's operations and development efforts.

Conclusion

NanoViricides is a pioneering clinical-stage biopharmaceutical company that has developed a unique nanomedicine platform to address the limitations of traditional antiviral therapies. The company's lead drug candidate, NV-387, has shown promising results in preclinical studies and has now successfully completed a Phase I clinical trial, paving the way for further advancement in the regulatory pipeline.

As NanoViricides focuses on initiating Phase II trials for MPOX and RSV, the company's broad-spectrum antiviral approach and its potential to overcome viral escape mechanisms position it as a frontrunner in the race to develop effective and versatile antiviral treatments. While the company faces the inherent risks associated with clinical-stage drug development, its innovative technology and the significant market opportunities in its target indications suggest that NanoViricides could play a transformative role in the future of antiviral therapeutics.

The company's financial position, with $3.96 million in cash and cash equivalents and a $3 million untapped line of credit, provides a foundation for near-term operations. However, securing additional funding will be crucial for advancing its clinical programs and maintaining long-term viability. As NanoViricides progresses through key milestones in its drug development journey, investors should closely monitor the company's clinical trial results, regulatory interactions, and financial developments to assess its potential for success in the dynamic and competitive antiviral market.

The headline is still sinking in: "NanoViricides Not Affected by Tariffs....."

OF COURSE IT'S NOT! Tariffs are charged on the value of goods....NNVC doesn't have any of those.

"This PR is a desperate attempt to prop up NNVC's share price by appealing to naked populism. It's an immoral and disgusting piece of crap."
Couldn't have said it better myself.

"This is because the vaccinated person will only become protected several weeks after receiving the vaccine dose."
That's Anal's reason not to do it? How many Doctors think like that? I'm sure glad my family Doctor didn't think like that 7 decades ago.

Agreed: All that's needed to limit transmission and spread of the disease is a proper vaccination policy using the highly effective and safe vaccines already available.

"Only a treatment for measles can effectively limit transmission of the virus and spread of the contagion, the Company believes."

The "Company" is talking shit.

All that's needed to limit transmission and spread of the disease is a proper vaccination policy using the highly effective and safe vaccines already available.

In fact, if vaccination rates approached 95-99%, measles could be eradicated altogether (but don't tell RFK jr. that - his worm-eaten brain can't cope with facts).

This PR is a desperate attempt to prop up NNVC's share price by appealing to naked populism. It's an immoral and disgusting piece of crap.

KInda what we expect from Diwan, TBF.

And yet - again - Diwan blathers on but continues to do nothing useful.

NanoViricides Not Affected by Tariffs and Other Policies, Has Excellent Long Term Outlook, Stock-Price Decline Misguided, Explains the Company

Shelton, Connecticut – Tuesday March 11, 2025.
NanoViricides, Inc. (the “Company”, NYSE-Amer.: NNVC), a clinical-stage global leader developing revolutionary broad-spectrum antiviral drugs that the viruses cannot escape, declared today that its business is not affected by the tariff policies of the US government or corresponding retaliatory policies of other governments, nor is it affected by the spending cuts being implemented by the current White House administration.

Therefore, the Company believes that smart financial strategists would view the longer term strong prospects of the Company (explained below) as supporting the case of NNVC as an effective hedge against the current general stock market turmoil.

Additionally, the Company reports that it does not develop vaccines. On the contrary, the Company is developing antiviral treatments, that are for helping patients infected by viruses.

“We believe that the policies of the current Secretary of HHS, Mr. Robert F. Kennedy, would lead to focusing more strongly on development of broad-spectrum antiviral treatments such as our clinical-stage as well as earlier-stage antiviral pipeline drug products rather than the previous vaccine-focused strategy,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company.

The Company has recently suggested that its revolutionary broad-spectrum antiviral drug NV-387 could have strong potential for the treatment of measles.

NV-387 was found to cure a lethal RSV infection in an animal model. Both Measles virus and RSV belong to the same family of viruses called paramyxoviruses. This family of viruses use heparan sulfated proteoglycans as their first stop, congregating next to cells, before gaining entry into cells.

There is no treatment available for measles; the lack of treatment is fueling the spread of this highly contagious disease.

Only a treatment for measles can effectively limit transmission of the virus and spread of the contagion, the Company believes.

It is illogical and unscientific to believe that vaccination, which is being widely promoted, would have any immediate effect for controlling the current outbreak. This is because the vaccinated person will only become protected several weeks after receiving the vaccine dose. Additionally, immune-compromised subjects cannot be vaccinated.

Although measles is spreading primarily in unvaccinated children, a small proportion of vaccinated persons is also being infected, and could suggest a drift in the virus towards partial vaccine escape. The rapid spread of measles in West Texas is bleeding into nearby areas due to travel. Several other states have reported independently initiated measles cases as well. So far there were two deaths with measles.

NV-387 mimics host-side signature required by viruses that does not change even as the viruses keep changing. In particular, NV-387 mimics heparan-sulfate-like structures to which over 90% of human pathogenic viruses are known to bind. NV-387 is a polymeric nanomachine that “looks like” a cell to the virus, and the virus ends up being engulfed by the shape-shifting NV-387 polymeric micelles, and thereby the virus is blocked from infecting cells in the first place.

The Company is currently working on a clinical trial application for enabling a Phase II human clinical trial to assess effectiveness of NV-387 for the treatment of MPox infection in the Central African region. An MPox epidemic has been raging in this region since June, 2024.

NV-387 could readily be approved for the treatment of MPox if successful in the Phase II clinical trial. There is no treatment for MPox at present.

NV-387 was found to be highly effective against Influenza A lethal infection in an animal model, significantly surpassing the effectiveness of known approved drugs including Tamiflu® and Xofluza®. These data indicate that NV-387 should be readily approvable for influenza virus infections. NV-387 is expected to be effective against bird flu viruses H5N1, H5Nx etc. as well.

NV-387 was found to be highly effective in lethal virus infection animal models for COVID. As of today’s 5-year anniversary of WHO declaration of the global COVID-19 pandemic, COVID has continued in the global population as endemic infections that produce sporadic waves. The only drug available remains Paxlovid® that was found to have no benefits compared to placebo in otherwise healthy adults that became sick with SARS-CoV-2 infection in clinical trials.

“We believe NV-387 has a bright future,” said Dr. Diwan, adding, “And we are strategizing to bring this future closer to reality every day.”

The Company has also developed a herpesvirus family antiviral, NV-HHV-1, that has indications against HSV-1, HSV-2, as well as VZV (shingles). NV-HHV-1 has gone through IND-enabling studies as a skin cream formulation for topical treatment of shingles rash, HSV-1 cold sores, and HSV-2 ulcers. The Company is developing a systemic drug based on NV-HHV-1 for oral treatment of herpesvirus infections as well. NV-HHV-1 awaits behind NV-387 in the pipeline for clinical development.

Additionally, the Company has also developed a drug against HIV/AIDS, namely NV-HIV-1. The Company believes NV-HHV-1 in combination with some of the existing drugs could lead to achieving cures of HIV infection.

“With all of these developments in progress, we are not exposed to current macroeconomic factors such as wars, tariffs, export taxes, or spending cuts,” said Dr. Diwan, explaining, “In fact, we believe that smart financial strategists would be recommending NNVC with its strong long term potential to act as a hedge against the current turmoil in the stock markets.”

“Therefore, we believe that the recent decline in the Company’s stock price concomitant with the general market sell-off is misguided and smart investors are expected to avail this dip opportunity,” said Dr. Diwan.

ABOUT NANOVIRICIDES
NanoViricides, Inc. (the "Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
Source: NanoViricides, Inc

NNVC under $2

NNVC..........................................................p/m

NNVC....................................https://stockcharts.com/h-sc/ui?s=NNVC&p=W&b=5&g=0&id=p86431144783

Flavor the month. There’s always an urgent, timely new virus for NNVC to shift its focus towards and thereby never having to move any “treatment” towards legitimate testing and trials. If Covid wasn’t big enough for them to rush their miracle snake oil to market, not sure what would be. But look at their history, their goal is not to get anything to trials (as they know what will happen). It’s to continue to Mille this for another 20 years. It’s an ATM for Diwan and his wife. If they do any legitimate testing, the gig is up. But don’t listen to me, I’m a known liar…right K?

Doctor Diwan, SIR
After over twenty years of reading and believing in what you have written and the reports you have released I believe I have a good grasp of your work.
Flu will be the biggest success, when you release it!
Now, if I have it right, NNVC can CURE the incredibly high percentage of mutations!!!s.
To raise capital very quickly we need a home run that will knock the ball out of the park!
Viruses don't have a name or target that they love! They just want to replicate, a human or animal makes no difference when it gets to a host environment.
AS a senior stockholder I would suggest using a two week window to target the "bird flu".
The Proper federal agency should go nuts over what the CURE could do for the 'cost of eggs".
The huge demand after you exhaust our inhouse facility will be very interesting! A challenge I hope you will accept!
When it works for you the rocket ship will be unbelievable.
boB
PS Thanks for considering this!
PPS A pr that says you are GOING to try to go in this direction will drive the market nuts!
B

NNVC..................https://stockcharts.com/h-sc/ui?s=NNVC&p=W&b=5&g=0&id=p86431144783

I’m not sure why, but I can’t believe you are still a believer. Now, more than ever, you have to admit I was right all along. Or couldn’t you care less?

Or more broadly:
https://clinicaltrials.gov/search?term=nanoviricides

EVER.

https://clinicaltrials.gov/search?intr=NV-387

Filed Friday: https://www.sec.gov/Archives/edgar/data/1379006/000205258725000002/0002052587-25-000002-index.htm

Uncle Miltie has assigned Powers of Attorney and says he is no longer a 10% owner.

Another clear-as-mud Diwan PR.Agreed

The badmouthing of the SIGA drug doesn't seem to be entirely justified.
https://en.wikipedia.org/wiki/SIGA_Technologies

However there does seem to be some justification for your question mark:
"So - it appears that they plan to target monkeypox for a Phase II?"

Another clear-as-mud Diwan PR.

NanoViricides Engages CRO for Phase II Clinical Trial - Odd though that the press release here doesn't mention any CRO by name.

So - it appears that they plan to target monkeypox for a Phase II?

https://finance.yahoo.com/news/nanoviricides-engages-cro-phase-ii-113000925.html

SHELTON, CT / ACCESS Newswire / January 27, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that it has engaged a Clinical Research Organization (CRO) to conduct a Phase II clinical trial advancing its broad-spectrum antiviral drug NV-387 further into the regulatory pipeline.

"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., further commenting, "Our regulatory development strategy for this drug is now further advancing into a Phase II clinical trial stage."

The Company has previously stated that it is working towards a Phase II clinical trial to evaluate the effectiveness of NV-387 for the treatment of MPox patients. MPox disease, caused by the human Mpox virus (hMPXV) has been causing a regional pandemic encompassing several countries in the African region, including the Democratic Republic of Congo (DRC), Uganda, and others. It led to the WHO declaring a Public Health Emergency of International Concern ("PHEIC") on August 14, 2024.

There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024.

In July 2024, SIGA received a procurement order for $112.5 million of oral TPOXX from the U.S. Government under the 19C BARDA contract, for delivery to the U.S. Strategic National Stockpile (SNS), despite the clinical trial failure. Additionally, in August, 2024, SIGA received a procurement contract and related order from the U.S. Department of Defense for approximately $9 million of oral TPOXX, as well as a small amount of IV TPOXX, despite clinical trial failure.

"These desperate attempts by the Previous US Administration to acquire an ineffective drug with hundreds of millions of dollars of taxpayer money only go to show how sorely a truly effective antiviral drug that works against MPox/Smallpox is needed by the government agencies," commented Anil R. Diwan, PhD, President and Executive Chairman of the Company.

NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.

In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.

Escape of virus from tecovirimat can occur by a single point mutation in a viral protein called VP-37.

In contrast, viruses are highly unlikely to escape NV-387 because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.

NV-387 is host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.

Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu®), baloxavir (Xofluza®) for Influenza are readily escaped by viruses wirth small changes that viruses undergo as they are faced with these challenges in the field.

Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.

NV-387 has already been found to be able to cure lethally RSV infected mice.

NV-387 was found to be significantly superior to oseltamivir (Tamiflu®), baloxavir (Xofluza®), and premivir (Rapivab®) in a lethal Influenza lung infection model designed to rank-order the effectiveness of these various drugs.

New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, as their limitations have become clearly evident during the COVID-19 pandemic.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.


This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.


The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

Where stated with an ® , the name is a registered trademark, which belongs to the owner of the trademark name.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:

NanoViricides, Inc., info@nanoviricides.com
Public Relations Contact: ir@nanoviricides.com

SOURCE: NanoViricides, Inc.

NanoViricides to Present at the Biotech Showcase in San Fransisco on Tuesday, January 14, 2025
6:31 AM ET 1/13/25 | Dow Jones
SHELTON, CT / ACCESSWIRE / January 13, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced today that it is presenting at Biotech Showcase(TM) 2025 in San Fransisco, being held in parallel to the JP Morgan Life Sciences Conference.

Oh Boy!!!!! Another meeting/conference???!!

So - Hey - Diwan - when is a new trial going to get going?

NanoViricides is in a Great Position to Fight Potential Bird Flu Pandemic with a Drug that the Mercurial H5N1 Influenza A Virus is Unlikely to Escape

https://markets.businessinsider.com/news/stocks/nanoviricides-is-in-a-great-position-to-fight-potential-bird-flu-pandemic-with-a-drug-that-the-mercurial-h5n1-influenza-a-virus-is-unlikely-to-escape-1034166815

Nothing particularly new or novel in this PR - Just allusions to two different Phase II type trials. Monkey Pox in Africa and "respiratory virus infections". No indication though as to when they might start, or how NNVC plans to pay for the trial expenses.

me

Nanoviricides means Kill virus particles. ( this is what the word cide means! KILL or CURE) and *Nano is for small virus cells.)

There is a WAR within our human body when we get infected with a virus! The war starts when the virus is somehow transmitted to our system. Our body is prepared to fight all types of viruses. And we need to win the war or else!
There are an estimated 10 nonillion individual viruses on our planet, which is enough to assign one to every star in the universe 100 million times over1. Each day, more than 700 million viruses, mainly of marine origin, are deposited from Earth’s atmosphere onto every square meter of our planet’s surface2. However, only about 9,110 named species of viruses are currently listed3. (internet)
In my mind I am looking at two armies in the HUMAN battlefield. The virus is looking for a host to invade and then replicate within and explode the cell (or leak out) when its offspring and mutations overflow the captured cell. There are millions of cloned cells and mutations that emanate from one captured host cell, each seeking to replicate its ancestor's actions. So it can take only one virus cell to continue the war. The virus can also duplicate itself in the bloodstream beginning or keeping its sickness active. This singular description is actually replicated hundreds of millions of times until every virus particle is killed and you are "CURED". Only when all the cells are eliminated can this be declared a WIN FOR THE BODY. The body can sometimes win slowly (or not), (my mom's Shingles lasted 9 months. but mine only 2 months). Without Nanoviricides' suicidal tanks cruising through the bloodstream the time to CURE is variable, if your body can cure itself

This company has expanded, and then contracted it's 'clinical research pipeline' for far too many years now.

Down again, I see.

Whatever NNVC is paying its social media pimps, it’s too much.

$NNVC's future looks bright as it expands its clinical research pipeline.
https://tinyurl.com/ya5zfmm9

In the future NNVC will be just another insider enrichment penny stock scam that gets delisted. After all, the CEO has form in that respect.

In the future, $NNVC could be the gold standard in virology.

https://profiles.smallcapsdaily.com/nnvc/

What bullshit. It’s down again.

NNVC needs new pimps - the current ones are pathetic.

Momentum grows for $NNVC—it’s trending across industries!
https://tinyurl.com/ye28duaz

"Good news has given $NNVC a boost"

What good news is that then? And where's this boost of which you speak?

I suspect that NNVC will eventually realise that paying penny stock pimps to tout their stock is a little like urinating in your trousers - it gives you a nice warm feeling at the time, but you soon come to regret it.

Good news has given $NNVC a boost, and the bullish sentiment on the charts is exciting.

Expect this stock to capitalize on emerging trends in the market!
https://tinyurl.com/kf7cb3e4

I wonder why NNVC has hired the dregs of the penny stock pimping business to tout its shares instead of focussing on R&D?

Maybe they’re not an R&D company after all, but just a share selling scam.

$NNVC is trending upward! Poised for a bullish run, this stock is a must-watch for impressive growth potential.

🚀 $NNVC is flying high—be part of this exciting upward trend!

In case you hadn’t noticed, NNVC’s price trajectory is downwards, both short term and long term.

That’s because it’s primarily a share selling operation, disguised as a would-be biotech start up.

$NNVC’s strong price action reflects its upward trajectory—exciting days ahead!
https://tinyurl.com/2ph6umwn

$NNVC’s antiviral approach has the potential to change the healthcare landscape forever.

$NNVC is making strides with rising prices and high trading volume.

💥 Attention! $NNVC is leading the way in revolutionary viral defense!

https://www.nanoviricides.com/

$NNVC’s bullish momentum is clear with its rising price and increasing market cap.

That explains the recent burst of activity here.

But I wonder why NNVC spends money on penny stock pimps when it's supposed to be a biotech R&D company?

Make it make sense, somebody.

Nonsense. Bought and paid for nonsense:
"SCD Media LLC (d/b/a “Smallcaps Daily”), hereinafter referred to as “Smallcaps Daily,” and their affiliates and control persons (the “Publisher”) are in the business of publishing favorable information and/or advertisements (the “Information”) about the securities of publicly traded companies (each an “Issuer” or collectively the “Issuers”) in exchange for compensation (the “Campaigns”)."
https://profiles.smallcapsdaily.com/nnvc/

$NNVC plans Phase II trials for MPox in Central Africa and RSV in the USA. Addressing urgent global health crises.
Know more: https://tinyurl.com/58b8wyjc

$NNVC is moving upward! Strong momentum points to potential gains.
http://tiny.cc/km9xzz

A real humdinger:
https://ih.advfn.com/stock-market/AMEX/nanoviricides-NNVC/chart/streaming

$NNVC continues to rise—an opportunity you can’t ignore!

https://www.nanoviricides.com/