And back up we go again,....

There are only two days when I care about share prices. These are the day (or days) when I chose to buy shares, and the day (or days) when I chose to sell them.

Your comparison here to a stock split doubling my share value is nonsense. Thanks for 'participating in the conversation' though.

A couple of weeks ago the share price was $2 or less. I'm guessing that $2 is what price that CVM could negotiate with whomever big-wig was willing to fork over that much operating capital. It's not the company's focus to maintain a particular share price for short-term traders or newly acquired shareholders looking for a quick score.

It's the company's focus to get Multikine to market, to start generating regular revenue on its own, or to attract interest from a big partner or buy-out pharma. To do that the company needed a sizable chunk of operating capital to keep moving forward. The price to the company for that new chunk of operating capital was a discount for the big investor who could provide that needed capital in the near term.

I bought some new shares this morning at around $2.30. Yeah, sure, they are down even a bit more since then, but I don't focus any money I invest in short-term gains/losses. When Multikine gains regulatory approval - be that in the EU, Great Britain, Canada or with the FDA - that resulting gain in share prices is going to be extremely substantial. Ditto with a buyout - if that's what ends up happening.

How does that recent Warren Buffett quote go: "The stock market is a device for transferring money from the impatient to the patient."

A bit of dilution - but not much compared to the total number of shares. We all kind of figured that something like this was going to happen and I think that the market is just doing it's usual bit of overreacting.

We'll see how this plays out today and Friday as the market digests this happening.

As expected - there was no real share price bounce from the information that the 'Cide currently in testing is also good for animal models against other viruses. Nothing consistently good is going to happen unless and until there is a positive Phase I result, and until after NNVC figures out how it is going to finance a larger Phase II trial.

Another day of solid volume and trending upward,... I could get very used to this trend.

And then a significant bounce-back,.... This stock isn't going to go anywhere steadily upward until after we see some results from the ongoing Phase I trial come out AND have those results look positive for the future of the 'Cide.

Still pretty solid volume today - and a nice reversal off of the morning dip.

Apparently somebody decided to cash out at the open. Although the share prices are starting to rebound again and still we are maintaining a fairly good volume.

Good volume here again today and a nice rise in share prices. Still more than a little bit of a way to go though as we started 2023 at about $2.70 and we were close to $3.70 this time last year. Let's hope that the management does actually have a plan this time.

Just because some people posting here think that Multikine will never be approved doesn't mean that no one believes that.

It's a question of when, and how much dilution we will accumulate in the meantime.

While I like what the letter is saying, and it is fairly clearly a net positive - I don't see share prices here going much of anywhere upward until there is some sort of go-ahead from one of the FDA, or the Canadian, British or EU regulatory authorities to do some sort of 'accelerated' approval for Multikine.

Until then we remain in danger of dilution, and in limbo, and the share prices will react accordingly.

NanoViricides, Inc.
Thu, October 12, 2023 at 6:45 AM EDT·10 min read

https://finance.yahoo.com/news/nanoviricides-inc-present-partnership-opportunities-104500220.html

SHELTON, CT / ACCESSWIRE / October 12, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), announces that the Company's President, Dr. Anil Diwan, will be presenting a talk in person at the Partnership Opportunities in Drug Delivery (PODD) Conference in Boston, MA, on October 16, 2023 at 6:07pm ET in Track 2B.

Dr. Diwan will present a talk entitled "Revolutionizing Antiviral Treatments - Orally Available Nanomedicines that Can Also Deliver Difficult APIs and Improve Their PK." His talk will focus on the following topics:

NanoViricides Flexible, Site-Targeting, Platform Technology is in Phase I

Orally Available, Broad-Spectrum Antivirals Platform Goes Beyond Immunotherapeutics

Escape of Virus is Not Likely

Curing Viral Infections is Within Reach

The NanoViricides technology platform has produced a highly effective, broad-spectrum antiviral drug candidate for the treatment of RSV, COVID-19, MERS, SARS, and many other viral infections. This drug, NV-387, is formulated into three different drug products, called (i) NV-CoV-2 Oral Gummies, (ii) NV-CoV-2 Oral Syrup, and (iii) NV-CoV-2 Solution for Injection, Infusion, and Inhalation.

The two oral formulations of NV-CoV-2 are in Phase 1a/1b clinical trial in India, sponsored by the Company's licensee and collaborator, Karveer Meditech Pvt. Ltd. The clinical trial includes single-ascending-dose (1a) and multiple-ascending dose (1b) arms in healthy subjects to evaluate the safety and pharmacokinetics in humans. In addition, the clinical trial also includes COVID-19 patient treatment arms in the multiple-ascending dose part (1b-COVID) that is designed to evaluate safety in COVID patients and to obtain efficacy parameters for dose regimen selection for Phase II/III clinical trials.

To date, 26 of 36 subjects have completed the study in the healthy subjects portion. No adverse events or severe adverse events were found and the drug was well tolerated even at the highest dosage tested. These results are consistent with the strong safety observed in pre-clinical studies.

Event

NanoViricides Presentation at the PODD 2023 Conference

Day & Date

Monday, October 16, 2023
Time, Track & Room
6:07pm ET, Track 2B, Room Independence AB, 4th Floor
Location
PODD, The Westin Copley Place, Boston, MA, USA.
Website
https://theconferenceforum.org/conferences/partners-in-drug-delivery/2023-2/#day-110364-tab

In addition to its strong effectiveness in pre-clinical studies against multiple coronaviruses,
NV-387 was also found to be highly effective as a treatment of RSV infection in a Lethal Lung Infection (ARDS/Pneumonia) Animal Model of the disease as previously reported. In this study, animals treated with oral NV-387 survived 15 days, almost matching the 16 days survival when treated with the highly toxic drug ribavirin. There is no treatment for RSV infection, other than ribavirin which is conditionally approved only for patients with high risk of progressively severe RSV disease, due to its significant side effects including hemolytic anemia and kidney failure.

We anticipate that NV-387 for treatment of RSV infection can enter into Phase II/III human clinical trials upon completion of its on-going Phase I human clinical trial.

The strong effectiveness as well as excellent safety of NV-387 observed in pre-clinical studies for multiple indications bodes well for the entire NanoViricides Technology Platform.

The Nanoviricides Platform also enables delivery of difficult active pharmaceutical ingredients (APIs) and improves their pharmacokinetic properties as demonstrated by the pre-clinical studies of NV-387-g-R (Remdesivir as a guest encapsulated within NV-387 polymeric micelles), and NV-387-g-Ribvp (a Ribavirin prodrug as a guest encapsulated within NV-387 polymeric micelles).

Viral infections can be cured by drugs utilizing power of the NanoViricides Platform that enables (a) "Re-Infection Inhibition", and (b) "Replication Inhibition" in a single drug, thereby blocking the virus lifecycle completely. The NanoViricides Platform also enables additional approaches towards potentially curing latent viral infections such as those caused by herpes family viruses (HSV-1, HSV-2, VZV, EBV, CMV, HHV-6A/B, HHV-7, KSHV), HIV and others.

Further applications of the Nanoviricides Technology Platform would be evident to researchers in their own unique fields to tackle other diseases.

In addition to the conference presentation, Dr. Diwan has scheduled several meetings at the Conference.

Dr. Diwan will present the Company's Assets and current development stage:

NV-CoV-2 (API NV-387): Clinical Stage. Treatment of COVID and certain cases of long COVID. Broad-Spectrum, Pan-coronavirus Drug "(viral) Resistance is Futile". Highly Effective and Extremely Safe in pre-clinical models. Excellent PK in monkey and rodent animal models.

NV-CoV-2-R: Encapsulates remdesivir within NV-CoV-2 substantially improving its PK profile and enabling synergistic drug action. Expect complete cure of coronaviruses by blocking both the re-infection cycle and replication cycle.

NV-HHV-1: Skin cream for treatment of Shingles rash. IND-enabling studies completed.

NanoViricides Technology Platform for Drug Encapsulation: The nanoviricides technology platform is proven to be capable of encapsulating and thus protecting a number of APIs improving their PK/PD and bioactivity. Enables long acting acute timeframe (~ 24 - 72 hours). Has enabled Oral, Transdermal, I.V. Injection, I.V. Infusion, and Lung Inhalation routes for drug delivery. Rescue drug candidates.

NanoViricides Technology Platform for Drug Development: Specific site-directed ligands for bind to viral surface glycoproteins enable blocking of re-infection and engulfment of the virus particle within the nanoviricide™ micelle. Expected to deliver encapsulated APIs to virally infected cells projecting viral glycoproteins, sparing normal cells from toxic antiviral APIs.

About PODD (from their website, https://theconferenceforum.org/conferences/partners-in-drug-delivery/overview/)

Pharma, biotech and the drug delivery industries gather annually at PODD to assess delivery needs, latest trends and information on deals and learn about a wide range of innovative drug delivery technologies that could improve the delivery of various types of drugs. This can include proteins, peptides, oligonucleotides, biologics, and small molecules and more. PODD provides business development opportunities through organized networking and a partnering tool for new, emerging and established collaborations.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 (API NV-387) for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced 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 factors including external collaborators and consultants. The NV-CoV-2 is currently in Phase 1a/1b clinical trial sponsored by our licensee and collaborator, Karveer Meditech, Pvt. Ltd., India.

NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide API, NV-387. NV-CoV-2 does not contain 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 RSV, 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 human Coronaviruses. The Company intends to obtain a license for poxviruses, RSV, enteroviruses, and others as and when the Company determines to further advance the drug development opportunity, if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.

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.

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". "Prodrug" means a chemical that is readily converted into the referenced drug in the body.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com

SOURCE: NanoViricides, Inc.

I was going to comment on 'why' NNVC was up almost $0.10 for the day,.... but then I realized that trading was almost non-existent today. And of course it's back down most of that gain already.

Nothing interesting is going to happen until there are some Phase 1b results to talk about.

CEL-SCI Files Request With the UK’s MHRA Regarding Path to Approval for Multikine in the Treatment of Head & Neck Cancer.

https://www.nasdaq.com/press-release/cel-sci-files-request-with-the-uks-mhra-regarding-path-to-approval-for-multikine-in

PUBLISHED
OCT 5, 2023 8:45AM EDT
CEL-SCI will present the MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously, as a result of an improved selection algorithm that more accurately predicts the patients who would benefit most from the Multikine therapy
UK has about 12,500 new head & neck cancer cases each year
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer.

At the meeting, CEL-SCI will present MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously. These new results arose from an improved selection algorithm of the Multikine target population. The improvements in the selection algorithm were based on discussions and feedback from regulators and consultants. This improved selection algorithm is able to more accurately predict the patients who would benefit most from the Multikine therapy.

A statistical validation of outcomes in the new target population, based on the Phase 3 study data, was recently concluded and will be presented at the Conference of the European Society for Medical Oncology (ESMO) which takes place October 20-24, 2023 in Madrid, Spain.

CEL-SCI is seeking a pathway towards approval of Multikine throughout the UK. CEL-SCI’s goal is to apply for marketing authorization in the UK as soon as possible, based on the data already generated. Just two weeks ago CEL-SCI filed a similar submission with the European Medicines Agency (EMA).

“We have a comprehensive global regulatory approval strategy,” stated CEL-SCI’s CEO Geert Kersten. “Having received encouraging submission guidance from Health Canada, we plan to file for a NOC/C conditional approval there. This pathway would allow CEL-SCI to request immediate approval based on the data generated to date, and any additional studies if needed would be done post-market. With the European Medicines Agency and the MHRA, we hope to do the same. We are extremely excited about the results seen in the newly defined Multikine target population.”

CEL-SCI’s pivotal Phase 3 study tested Multikine in newly diagnosed locally advanced head and neck cancer patients. The study demonstrated a nearly 4-year median overall survival benefit for Multikine treated patients who were treated with surgery and radiotherapy versus the control group who did not receive Multikine. The dire need for a new and effective treatment for newly diagnosed locally advanced primary head and neck cancer is widely recognized in the medical community.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study enrolled 928 patients.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2022. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.



View source version on businesswire.com: https://www.businesswire.com/news/home/20231005175200/en/

Gavin de Windt CEL-SCI Corporation (703) 506-9460

Source: CEL-SCI Corporation

At least they are doing something to get this drug into some market somewhere.

Can't say I disagree with either of you two about 'bottoming' and CVM. If there is an offering in the near future - and that is a high probability IMO as well - and if they haven't also gotten some good news back from the FDA or the EU/Canadian regulators that gooses the stock price back up some, the dilution is going to hurt currently shareholders quite a bit.

I'm not selling what I am holding, but I am certainly NOT adding shares until that particular shoe falls.

Seems to be some positive movement (for a change) on some decent volume today. How knows why at this point as I know I haven't seen any news recently.

And still a lot of nothing going on here.

Still a lot of nothing going on this summer,...

And up another 20% so far today. Apparently that news out of India is going over well. Who would have guessed that getting a clinical trial running might actually make the needle move?

Up 10% today. Interesting. Its good to see something like a progress report from NNVC.

https://finance.yahoo.com/news/phase-1a-1b-human-clinical-104500663.html?guccounter=1&guce_referrer=aHR0cHM6Ly9zdG9ja3R3aXRzLmNvbS8&guce_referrer_sig=AQAAAFZhs8tVWBO-UvRR7WHmg8W32AOwnsV-XPX6YGrnDvhsvPWdYFzpZynRJ4dm7fvK8549RYl-9BPhw32eoYgQ14X7JLkaMYQl2z_j3Ogr4fHq5vH9sehuLIJM3wM6b7RrJYC-NWUqGLU_U4thXNcfNuizTk4jlSaLrjNYcVJLfnRc

A partnership would be a good sign and very welcome at this point. It would definitely stop some of the current share price hemorrhaging. But as usual with these guys - I'll not be holding my breath waiting.

Agreed. A lack of follow-up is kind of irritating. Even a quick note stating - Hey, we are starting the Phase 1b portion on (fill in the date). All needed resources to do so have been put into place.

That would be appreciated.

Ha! I think the same thing here with CVM and most of the other speculative biotech stocks that I put money into. That often seems to happen in the near term.

Agreed - I did add some shares after the price drop here. My outlook here hasn't changed in the long-run as assuming that management continues to make progress in moving forward with the FDA, Canadian or EU authorities over the next few months.

Agreed.

If the criteria the FDA wants tested is to test the correlation between CVM's Multikine treatment selection and short-term tumor response (shrinkage) then it may take a while to set up the Trial & wrangle a relevant patient pool. That is true.

However, collection of the data on tumor response after 3 weeks of treatment should be quick.

Also, I am in agreement with some others here that this trail could be done as part of a conditional approval process.

I'm NOT really complaining - but this statement near the end of that article is more than a bit 'rich' after this company bounced from disease, to disease, to disease, to disease for the last decade+

Company’s Broad-Spectrum Antiviral NV-387 Has Demonstrated Excellent Effectiveness in RSV in a Lethal Lung Disease Animal Model, Reports NanoViricides
https://finance.yahoo.com/news/company-broad-spectrum-antiviral-nv-104500702.html

SHELTON, CT / ACCESSWIRE / July 11, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the strong effectiveness of its broad-spectrum antiviral clinical drug candidate NV-387 in an animal model of lethal lung infection with RSV (Respiratory Syncytial Virus).

NV-387 Can Advance Directly into Phase II Human Clinical Trials for RSV Treatment:
NV-387 is the active ingredient of NV-CoV-2, the Company's drug for the treatment of COVID and possibly long COVID. It is already in Phase 1a/1b human clinical trials for the evaluation of safety in healthy volunteers and of safety and preliminary efficacy in COVID patients as previously reported.

It is expected that NV-387 can be advanced into Phase II studies against RSV once the current Phase I studies of NV-CoV-2 are completed. This will significantly speed up the development of the RSV drug, save costs, and improve return on investments (ROI).

"We are very pleased with the extremely high effectiveness of NV-387 in combating RSV", said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Importantly, both oral administration and intravenous injection of NV-387 were highly effective. This study further establishes the broad-spectrum antiviral effectiveness of NV-387, and further solidifies our novel nanoviricides platform technology."

RSV is an Important Acute Lower Respiratory Infection (ALRI; includes Pneumonia)[1]:
Each year in the United States, an estimated 58,000-80,000 children younger than 5 years old are hospitalized due to RSV infection. Globally, RSV is a common cause of childhood ALRI and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3·2 million hospital admissions, and 59,600 in-hospital deaths in children younger than 5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than 6 months.

There are No Effective Treatments for RSV:
Two vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo (Pfizer) were approved in May, 2023 for use in adults over 60 years of age and both reduced severity of RSV infection. There are no vaccines currently approved for infants and children.

However, there are no effective therapeutics for RSV to date. Ribavirin is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. Synagis (palivizumab), an antibody, is approved only as a prophylactic in children and infants at high risk of severe RSV infection, but it is not approved for treatment of RSV infection.

Market Size of RSV Therapeutics is Expected to Hit US$ 8.73 Billion by 2031[2]:
GrowthPlus Reports, in June 2023, says the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.

NV-387 Injection was Found to be Highly Effective Against a Lethal Direct-Lung RSV infection in a Mouse Model:
Animals treated with injection vehicle solution alone survived 7 days. Ribavirin, a toxic drug, was used as a positive control. Animals treated with injections of ribavirin survived 16 days, whereas animals treated with injectable NV-387 survived 15 days, almost matching the efficacy of ribavirin treatment.

NV-387 Administered by Oral Gavage was also Found to be Highly Effective in the Same Lethal Direct-Lung RSV Infection Study:
Animals treated with oral drug vehicle alone survived 7 days. Orally administered Ribavirin, a toxic drug, was used only as a positive control. Animals treated with oral ribavirin survived 16 days, whereas animals treated with oral NV-387 survived 15 days, again almost matching the efficacy of ribavirin treatment.

Unlike ribavirin, NV-387 has been found to be extremely safe in preclinical studies. Therefore, it would be possible to increase the dose level or frequency of NV-387 to increase its effectiveness. Thus this study demonstrates that NV-387 is a highly effective drug candidate for the treatment of RSV infection with significant patient benefits.

NV-387 Demonstrated Very High Oral Bioavailability in This Study:
The dosing of NV-387 orally given was twice as much as that given by I.V. injection to compensate for oral bioavailability. The apparent oral bioavailability of NV-387 based on efficacy parameters appears to be of the order of almost 50% in this study, a very high value.

NV-387 Acts by a Novel Mechanism:
The Company developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It was designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering it incapable of infecting another cell.

The Company calls this novel antiviral mechanism "Re-Infection Blocker".

Expanding Indications of NV-387:
NV-387 employs mimics of well known attachment sites on the cells commonly used by viruses called sulfated proteoglycans. Since these attachment receptors are used by over 90% of human pathogenic viruses, the Company anticipated that NV-387 may have effectiveness against many viruses beyond coronaviruses, our initial focus.

RSV is the first non-coronavirus that the Company has evaluated for susceptibility to NV-387.

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 are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 through Phase I/II human clinical trials.

NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. 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 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 poxviruses, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.

Disclosure Statement: 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 that are, in some cases, beyond the Company's control and that 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. In particular, 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 in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.

[1] Lancet 2017; 390: 946-58

[2] https://finance.yahoo.com/news/respiratory-syncytial-virus-rsv-therapeutics-093200835.html?guccounter=1&guce_referrer=aHR0cHM6Ly9kdWNrZHVja2dvLmNvbS8&guce_referrer_sig=AQAAAJXyjZT5Eielym71qZ0IBGYvgi3hzLSE58E-lHgXYBqe05twy3ZebjDbrt-UQegh3oVT7jvFPFYFIUfhjVwW0eguJwwbdSkRaOqkUrwAE38mmEqGdq_TJ1mwmBd95cGsHyvreIVtgdVm2RhQfzyUiQvFrjQKvale9YMdc5vLUTFc .

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com

SOURCE: NanoViricides, Inc.

We're up almost to $1.60 (it was briefly up to $1.74) so far today. It appears that 'the market' liked that last PR about the RSV in animal models. It that's true - Diwan may have finally gotten this company moving forward with a useful product.

The self-dealing CEO will - of course - massively benefit while we at least start to get something for our time and patience.

Clinical Trial of Broad-Spectrum Antiviral Drug NV-CoV-2 is Progressing Well, Says NanoViricides - NV-CoV-2 is Positioned to Fulfill Many Unmet Medical Needs
6:45 AM ET 7/6/23 | Dow Jones

SHELTON, CO / ACCESSWIRE / July 6, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") reports that the clinical trial of its broad-spectrum antiviral drug NV-CoV-2 is progressing satisfactorily.

NanoViricides is a clinical-stage global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform. NV-CoV-2 (API NV-387), our lead drug candidate for the treatment of coronavirus infections including COVID and potentially many cases of long COVID, is in Phase1a/1b Safety and Preliminary Efficacy Human Clinical Trials initiated by the Drug Sponsor Karveer Meditech Pvt. Ltd. India, the Company's Licensee and co-developer in India.

Following safety and tolerability evaluation in healthy persons for a single escalating dose of NV-CoV-2 Oral Syrup or NV-CoV-2 Oral Gummies in the Part 1a, the clinical trial will continue into Part 1b if there are no serious adverse events.

Phase 1a is Progressing Rapidly:

Enrollment in the third and highest single dose level of 40mg/Kg NV-CoV-2 Oral Syrup, and separately, 2,000mg NV-CoV-2 Oral Gummy has already begun. The lowest dose cohorts in the clinical trial (10mg/Kg Oral Syrup, and separately, 500mg Gummy) have completed, and the middle dose cohorts (20mg/Kg Oral Syrup, and separately, 1000mg Gummy) have been substantially completed allowing the highest dose cohorts to begin. Each person after dosing is under observation (in-hospital stay) for 48 hrs, followed by a scheduled follow-up visit.

There were no adverse events to date at any of the dose levels including the highest dosages.

Phase 1b to Begin Shortly:

In Phase 1b, healthy persons will be dosed with multiple doses of the Oral Syrup and separately, Oral Gummies to study Safety and Tolerability.

Additionally, in Phase 1b, in separate cohorts, patients with mild to moderate/severe COVID-19 shall be enrolled to assess indication of efficacy. Patients deemed by the physician to be likely to require hospitalization within 48 hrs of screening will be excluded.

"We are pleased with the success of the clinical trial so far and look forward to the start of the Phase 1b portion soon," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, explaining, "This clinical trial we believe will be a springboard for NV-CoV-2 to launch into multiple antiviral indications in the near future. NV-387 is designed as a bio-mimetic that can possibly be an effective drug against many viruses including the coronaviruses. If successful, it is poised to satisfy many as yet unmet medical needs for the global population, not just limited to COVID."

"Resistance is Futile": NV-387, the active pharmaceutical ingredient of NV-CoV-2 is designed to mimic a cell membrane with a number of so called "attachment receptor sites" chemically covalently connected to each polymer chain in the nanomicelle. No matter how much a virus changes, it still binds to the same attachment receptor(s), and therefore, it is unlikely to escape the nanoviricide drug.

This design we believe solves the major issue of small molecule as well as antibody therapeutics, namely, development of resistant virus variants.

NV-CoV-2 is Aimed at Satisfying Many Unmet medical Needs in COVID: NV-CoV-2 was shown to be extremely safe in pre-clinical animal studies. It was also found to be extremely effective in lethal infection animal model studies.

Thus we believe that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage.

In contrast, existing COVID therapeutics are limited in the treatable segment(s) of population; thus, Remdesivir is indicated for hospitalized patients only; Molnupiravir and Paxlovid are both indicated for patients over 65 years of age with co-morbidities that are not taking other drugs that would cause interactions. This leaves a large patient population that is unserved.

Further, we believe that NV-387 may become an important drug for the treatment of certain cases of long COVID wherein residual virus is known to be present.

NV-387 May Have a Very Large Range of Indications, because Over 90% of All Human Viruses Use the Attachment Receptor(s) Mimicked by NV-387:

NV-387, the active pharmaceutical ingredient of NV-CoV-2, mimics a family of attachment receptors called sulfated proteoglycans (S-PG), or glycosaminoglycans (GAGs). This family includes heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (CSPG). Over 90% of known pathogenic viruses bind to one or more of these attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human MetaPneumoVirus), Dengue Viruses, HerpesViruses, Human PapillomaViruses (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others.

NV-387 is likely to be effective as a clinically viable drug candidate against at least some of these viruses, we believe. Many of these viruses have no available antivirals or have antivirals with limited applicability.

We have already undertaken a program to expand the potential indications of NV-387. Success in any of these studies would enable direct entry into Phase II/III clinical trials for that indication.

Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI).

On June 29, 2023, we reported that the Phase 1a/1b human clinical trials referenced above began on June 17,(,) 2023. The team behind the clinical trials was also described therein.

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(R) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 through Phase I/II human clinical trials.

NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour(R) 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 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 poxviruses, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.

Disclosure Statement

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 that are, in some cases, beyond the Company's control and that 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

(MORE TO FOLLOW) Dow Jones Newswires

July 06, 2023 06:45 ET (10:45 GMT)

One week we drift up a bit,.... next week we drift right back on down. Nothing much is going to change for us here until there's news that some regulatory body for drugs 'somewhere' is approached for an meeting that starts leading to some kind of regulatory approval for Multikine.

I took the tax loss from this a couple of years ago to help offset a gain elsewhere.

C'est le vie?

Hope you are doing well.

Well said Sir!

What you said Sir!

Not completely worthless though. Mostly a Phase I is geared toward assessing general safety and dosage ranges. If they figure that out then it's done its job. An open label study can still get the data that they need here.

If they get some data from the 1b group indicating that viral load decreases, or that symptoms show some improvement, that sets up a potential Phase II and gives self-dealing Diwan something to try and sell in a partnership with some other, bigger pharma fish.

One bonus to a potential COVID treatment is that 'if' it works, 'then' its going to work quickly or not at all. It won't take forever to actually 'do' the Phase I, and a Phase II should be similarly quick to see results, or the lack of results.