La cadena de opciones muestra datos clave de las opciones de acciones de Nanoviricides a varios precios de ejercicio y fechas de vencimiento. Los operadores utilizan esta información para analizar posibles operaciones y evaluar el sentimiento del mercado para Nanoviricides..

Nanoviricides (AMEX:NNVC) Bolsa, Cadena de Opciones

Nanoviricides

Nanoviricides Inc is a nano-biopharmaceutical company that is engaged in discovering, developing, and commercializing therapeutics to advance the care of patients suffering from life-threatening viral infections. The company engaged in the application of nanomedicine technologies to the complex issues of viral diseases. It focuses its research and clinical programs on specific anti-viral therapeutics and is seeking to add to its existing portfolio of products through its internal discovery and clinical development programs and through in-licensing.

Nanoviricides Inc

The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial:
safe and effective dosing regimen in patients,
safety and tolerability of the drug in patients, and
antiviral effectiveness of the drug in patients.
The overall clinical trial will enroll approximately 80 patients.
"This is an important milestone towards filing of the clinical trial application and starting the clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Our CRO and the Principal Investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease."
Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease.
NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus.
If NV-387 is found to be effective in this Phase II clinical trial, the Company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as Smallpox indications. The Company intends to obtain regulatory approval in the African Region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions.
MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for Orphan Drug Designation by the US FDA with attendant benefits.
Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the Company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over $600 million through December 31, 2024, according to SIGA's annual report to the SEC [1] .
The adaptive, randomized, SOC controlled clinical trial will proceed in two parts:
In Phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease.
There will be two arms in this Phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus SOC and the control SOC Arm of 10 patients. The dosing regimen for Phase IIb will be determined on the basis of Phase IIa results.
In the Phase IIb part, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment Arm and 20 patients in the SOC Arm. Evaluations will be similar to those in Phase IIa, with more emphasis given to specific points that may have come up in Phase IIa regarding safety, tolerability, as well as efficacy.
The Phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region.
The "NV-387 Oral Gummies" drug product formulation will be employed in the Phase II. This is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash.
Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA "Animal Rule," i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial.
Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the "MOSA" clinical trial [2] . The topline results were expected to be announced as early as CY Q1 (March 2025) and efficacy topline data were expected no later than CY Q2 (June, 2025). No press releases post initiation of the MOSA clinical trial could be found.
The MPox virus circulating in DRC and neighboring regions is of Clade 1a and Clade 1b subtypes, with the latter predominant. Clade 1b is more transmissible of the two, which is why it has resulted in a sustained epidemic. The MPox Clade 1a case fatality rate (CFR) is about 3%-11% whereas the CFR for Clade 1b is about 1%. The MPox Clade 2b is the virus causing continuing cases in the Western world, which causes a much less severe disease than Clade 1a/1b and has a very low CFR, according to CDC. Sporadic cases of Clade 1 in the Western world continue to occur. Four separate travel-related MPox Clade 1 cases reported in the USA that did not result in any further spread, since November 2024, according to the CDC [3] .
Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve.

Biotech

News

Health Care

General

NNVC

Nanoviricides Announces That The Design Of The Adaptive Clinical Trial Protocol For Mpox Virus Clade Ia And Ib Infections And Disease Is Nearly Complete

NanoViricides Announces That It Is Forging Ahead With Its Measles Drug Development Program

WIIM

NanoViricides shares are trading higher after the company announced it has been cleared by the DRC Ethics Committee to file a Phase II trial application for oral NV-387.

NanoViricides Says It Has Been Cleared To File Phase II Trial Application For Oral NV-387 in MPox Treatment by DRC Ethics Committee; Company Says It Is Also Readying To Combat Measles Outbreaks, And To Tackle Bird Flu

Nanoviricides (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/NNVC#AMEX">NNVC</a>) reported quarterly losses of $(0.14) per share. This is a 12.5 percent increase over losses of $(0.16) per share from the same period last year.

Earnings

Nanoviricides Q3 GAAP EPS $(0.14) Up From $(0.16) YoY

NanoViricides, Inc. (NYSE Amer.:<a href="https://pr.report/a88f">NNVC</a>) (the "Company") today reported that it has received approval from the National Ethics Committee for Health (CNES) of the Ministry of Public Health (MSP), of the Democratic Republic of Congo (DRC). With this CNES approval, the proposed Phase II clinical trial to evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection is cleared for further regulatory filing of a complete Clinical Trial Application ("CTA").
The approval that we have now received from CNES clears the path for the perfected CTA filing to the MSP for approval and start of the clinical trial.
There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX&#xAE;, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024.

NanoViricides Secures CNES Approval For NV-387 Phase II Clinical Trial In Democratic Republic Of Congo

NanoViricides Targets Measles With Broad-Spectrum Antiviral NV-387 As Vaccination Rates Decline

NanoViricides, Inc., a publicly traded company (NYSE Amer.:<a href="https://pr.report/9drn">NNVC</a>) (the "Company"), and a leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has begun evaluation of its clinical drug NV-387 for the treatment of the Measles virus.
"A drug for measles is at present a completely missing link in the response to measles virus outbreak," said Anil R. Diwan, Ph.D., President &amp; Executive Chairman of the Company, declaring, "Viral spread cannot be contained without an effective drug to minimize illness and stop the virus transmission from the patients."
NanoViricides already has a clinical stage broad-spectrum antiviral drug NV-387 that may be effective for treating Measles infection. NV-387 was found to cure lethal RSV infection in an animal model. Measles virus is related to RSV, and both use the heparan sulfate proteoglycan (HSPG) for infection. NV-387 mimics HSPG, presents itself as a decoy to the virus, and is capable of destroying the virus particle thereby stalling the continuous infection and spread of virus in the body. This provides strong rationale for use of NV-387 to combat Measles virus.
NanoViricides is open to enabling use of NV-387 to combat Measles virus infection in hospitalized patients and welcomes inquiries that are consistent with current FDA regulatory requirements under "Emergency Expanded Access for an Individual Patient" and under "Expanded Access for an Individual Patient".
NV-387 has already completed a Phase I human clinical trial with no reported adverse events, indicating excellent safety and tolerability. Additionally, NV-387 was found to be substantially more effective than approved drugs (where available) against Influenza, COVID-19, RSV, and MPox in relevant animal models. These four unrelated viruses have in common the fact that they all use HSPG for infection.
The Company has planned additional laboratory studies to evaluate the effectiveness of NV-387 against Measles virus infection in cell culture and animal models to support a future IND application, although we believe the results of these studies would not be required for use of NV-387 under FDA regulations pertaining to "Emergency Expanded Access for an Individual Patient".

NanoViricides Evaluates Drug NV-387 for Measles Treatment, Targets Virus Spread with New Antiviral Approach

NanoViricides Says Business Is Not Affected By The Tariff Policies Of The US Government

NanoViricides' NV-387 Promises To Be An Effective Drug To Treat Measles

NanoViricides Says Its Antiviral Drug NV-387 Can Fight Bird Flu Pandemic

<h3>Gainers</h3>
<ul>
<li>Oragenics (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/OGEN#AMEX">OGEN</a>) shares rose 83.4% to $0.52 during Wednesday's pre-market session. The company's market cap stands at $7.1 million. </li>
<li>Pasithea Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTTA#NASDAQ">KTTA</a>) shares moved upwards by 71.63% to $3.57. The company's market cap stands at $4.5 million. </li>
<li>Mainz Biomed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MYNZ#NASDAQ">MYNZ</a>) stock moved upwards by 17.14% to $8.2. The market value of their outstanding shares is at $18.2 million. </li>
<li>Titan Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TTNP#NASDAQ">TTNP</a>) shares moved upwards by 14.46% to $3.72. The company's market cap stands at $3.4 million. </li>
<li>SenesTech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNES#NASDAQ">SNES</a>) stock moved upwards by 11.88% to $3.39. The market value of their outstanding shares is at $3.5 million. </li>
<li>Nanoviricides (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/NNVC#AMEX">NNVC</a>) shares moved upwards by 11.75% to $1.27. The market value of their outstanding shares is at $18.2 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Nuvectis Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVCT#NASDAQ">NVCT</a>) stock fell 14.3% to $6.0 during Wednesday's pre-market session. The company's market cap stands at $115.9 million. </li>
<li>EyePoint Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EYPT#NASDAQ">EYPT</a>) stock declined by 14.18% to $6.54. The market value of their outstanding shares is at $446.3 million. </li>
<li>Universe Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UPC#NASDAQ">UPC</a>) shares fell 14.01% to $0.23. The company's market cap stands at $2.0 million. </li>
<li>Anitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) stock fell 13.59% to $0.28. The company's market cap stands at $3.4 million. </li>
<li>Evaxion Biotech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EVAX#NASDAQ">EVAX</a>) shares declined by 10.4% to $2.93. The company's market cap stands at $18.3 million. </li>
<li>HCW Biologics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCWB#NASDAQ">HCWB</a>) shares fell 9.95% to $0.49. The company's market cap stands at $21.8 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Movers

AZTR

EVAX

EYPT

HCWB

KTTA

MYNZ

NVCT

OGEN

SNES

TTNP

12 Health Care Stocks Moving In Wednesday's Pre-Market Session

NanoViricides shares are trading higher after the company announced it has engaged a clinical research organization to conduct a Phase II trial for its antiviral drug, NV-387.

NanoViricides Engages A Clinical Research Organization To Conduct A Phase II Trial For Antiviral Drug NV-387

<a href="https://ldh.la.gov/news/H5N1-death#:~:text=The%20Louisiana%20Department%20of%20Health,to%20have%20underlying%20medical%20conditions.">https://ldh.la.gov/news/H5N1-death#:~:text=The%20Louisiana%20Department%20of%20Health,to%20have%20underlying%20medical%20conditions.</a>
&nbsp;
<h3>Current general public health risk remains low</h3>
January 06, 2025
The Louisiana Department of Health reports the patient who had been hospitalized with the first human case of highly pathogenic avian influenza (HPAI), or H5N1, in Louisiana and the U.S. has died. The patient was over the age of 65 and was reported to have underlying medical conditions. The patient contracted H5N1 after exposure to a combination of a non-commercial backyard flock and wild birds.&nbsp;
LDH&#39;s extensive public health investigation has identified no additional H5N1 cases nor evidence of person-to-person transmission. This patient remains the only human case of H5N1 in Louisiana.&nbsp;
The Department expresses its deepest condolences to the patient&#39;s family and friends as they mourn the loss of their loved one. Due to patient confidentiality and respect for the family, this will be the final update about the patient.&nbsp;
While the current public health risk for the general public remains low, people who work with birds, poultry or cows, or have recreational exposure to them, are at higher risk.&nbsp;
The best way to protect yourself and your family from H5N1 is to avoid sources of exposure. That means avoiding direct contact with wild birds and other animals infected with or suspected to be infected with bird flu viruses.&nbsp;
Protecting yourself and others from H5N1 infection
<ul>
<li>Do not touch sick or dead animals or their droppings and do not bring sick wild animals into your home.</li>
<li>Keep your pets away from sick or dead animals and their feces.</li>
<li>Do not eat uncooked or undercooked food. Cook poultry, eggs and other animal products to the proper temperature and prevent cross-contamination between raw and cooked food.</li>
<li>Avoid uncooked food products such as unpasteurized raw milk or cheeses from animals that have a suspected or confirmed infection.</li>
<li>If you work on poultry or dairy farms, talk to your provider about getting your seasonal flu vaccination. It will not prevent infection with avian influenza viruses, but it can reduce the risk of coinfection with avian and flu viruses.</li>
<li>Report dead or sick birds or animals to the USDA toll-free at 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab at 318-927-3441.</li>
</ul>
If you have been exposed to sick or dead birds or other animals or work on a farm where avian influenza has been detected, watch for respiratory symptoms or conjunctivitis. If you develop symptoms within 10 days after exposure to sick or dead animals, tell your healthcare provider that you have been in contact with sick animals and are concerned about avian influenza. This will help them give you appropriate advice on testing and treatment. Stay home and away from others while you have symptoms.

AEMD

NVAX

'LDH Reports First U.S. H5N1-Related Human Death' - Louisiana Department Of Health

NanoViricides, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NNVC#NYSE">NNVC</a>) (the "Company"), says that its broad-spectrum antiviral drug candidate NV-387 is the best weapon to fight a potential bird flu pandemic because the mercurial H5N1 Influenza A virus would not be able to escape the drug.
"Despite all changes, the H5N1 Influenza A virus should remain susceptible to NV-387 because NV-387 mimics the very essential host-side feature that H5N1 continues to use even as it changes," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding "This drug puts us in a great position to be able to fight a bird flu pandemic should it happen."
WHO has stated "Available virus sequences from human cases [of H5 infection] have shown some genetic markers that may reduce susceptibility to neuraminidase inhibitors (antiviral medicines such as oseltamivir) [NAIs] or endonuclease inhibitors (such as baloxavir marboxil) [PBIs]" in their updated public health assessment of recent Influenza A H5 infections, dated December 20, 2024

NanoViricides Claims NV-387 Could Be Key in Fighting Bird Flu Pandemic

NanoViricides, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NNVC#NYSE">NNVC</a>) (the "Company"), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2024 with the Securities and Exchange Commission (SEC) on Friday, September 27, 2024. The report can be accessed at the SEC website (<a href="https://pr.report/33za">https://www.sec.gov/ix?doc=/Archives/edgar/data/1379006/000141057824001650/nnvc-20240630x10k.htm</a>).
We reported that, as of June 30, 2024, we had cash and cash equivalent current assets balance of approximately $4.97 Million. In addition, we reported approximately $7.5 Million in Net Property and Equipment (P&amp;E) assets (after depreciation). The strong P&amp;E assets comprise our cGMP-capable manufacturing and R&amp;D facility in Shelton, CT. The total current liabilities were approximately $1.36 Million. In comparison, as of June 30, 2023, we had cash and cash equivalent balance of approximately $8.15 Million, P&amp;E assets of approximately $8.1 Million (after depreciation), and total current liabilities of approximately $0.53 Million.
The net cash utilized in the reported period for operating activities was approximately $6.31 million that included certain expenditures for Phase Ia/Ib clinical trial of NV-387 and drug manufacturing costs for this clinical trial.
We raised approximately $3.12 million net of commission and certain expenses in an At-the-Market offering ("ATM") in the reported period at an average share price of $2.47.
With an additional raise of approximately $1.53 million subsequent to the period under the ATM, and an available line of credit that was increased to $3 million from $2 million provided by our founder and President Dr. Anil Diwan, we have approximately $9.5 million (approximately $8.1 million net of current liabilities) available for cash operational expenses going forward. As such, we reported that we do not have sufficient funding in hand to continue operations through September 30, 2025, for our planned objectives that include a Phase II clinical trial of NV-387 for RSV indication in the USA. As a result substantial doubt exists about the Company's ability to continue as a going concern, as evaluated based on applicable guidelines. We are actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to our plan. We believe that the Company has on-going access to the capital markets including the "At-The-Market" (ATM) agreement that became active around April 5, 2024. We have perviously adjusted our objectives and development plans on the basis of available resources and we will continue to do so.
NV-387 - A Potentially Revolutionary Antiviral Drug that the Viruses are Unlikely to Escape
We have made significant progress in the regulatory advancement of NV-387. A Phase Ia/Ib clinical trial in healthy subjects was completed with all subjects discharged as of end of December, 2023. There were no adverse events reported. Lab data analysis is currently being conducted. We are awaiting a final report.
Additionally, we have made significant progress in expanding the indications of NV-387, that would result in substantial improvement in the return on investment when regulatory approvals are obtained.
Our host-mimetic, direct-acting, broad-spectrum, antiviral agent. NV-387 was found to have activity that surpassed the activity of known agents in lethal virus infection animal model trials for COVID, RSV, and Influenza.
In fact, we found that NV-387 treatment possibly completely cured the lethal RSV infection in mice, based on indefinite survival of the animals with no lung pathology. There is currently no treatment for RSV infection. In particular, pediatric RSV infection treatment is an unmet medical need that we believe is of critical importance. Pediatric RSV treatment itself is expected to be a multi-billion-dollar market in the USA alone.
NV-387 treatment was found to be substantially superior to three approved anti-influenza drugs, namely, oseltamivir (Tamiflu&#xAE;, Roche), peramivir (Rapivab&#xAE;, Biocryst), and baloxavir (Xofluza&#xAE;, Shionogi/Roche).
Additionally, NV-387 also demonstrated activity against lethal poxvirus infection animal models that was on par with the approved drug tecovirimat (TPOXX&#xAE;, SIGA).
NV-387 acts by a mechanism that is significantly different compared to the tested existing antiviral agents for Influenza and for Poxviruses.
This demonstrated broad-spectrum activity of NV-387 against widely varying viruses is because NV-387 is designed to attack the virus particle by mimicking sulfated proteoglycan (S-PG) feature, and all of these viruses are known to utilize heparan sulfate proteoglycans for gaining cell entry.
Further, for all of these tested viruses, even as the virus genome changes in the field, NV-387 is expected to continue to be effective, and the virus would be highly unlikely to escape NV-387. This is because despite all of the genomic changes, the virus continues to use HSPG, as is well known. Thus NV-387 solves the greatest problem in antiviral countermeasures; the problem of virus escape. Viruses are known to escape all of the current antiviral tools that include vaccines, antibodies, and small chemical drugs.
Thus we anticipate that NV-387 would revolutionize the treatment of viral infections reminiscent of how penicillin revolutionized the treatment of bacterial infections.
Advancing NV-387 into Phase II Clinical Trials
In the ensuing year, we plan on advancing NV-387 into Phase II clinical trials. We believe that NV-387 qualifies under the MEURI WHO protocol to enter Phase II clinical trial for the treatment of MPOX disease that is a current epidemic in Central Africa (MEURI = Monitored Emergency Use of Unregistered and Investigational Interventions). This epidemic was declared a Public Health Emergency of International Concern (PHEIC) by the WHO in August, 2024. There is currently no drug available for treatment of MPOX since the clinical trial of tecovirimat did not demonstrate improvement in outcomes as compared to the standard of care, according to a press release by NIH in August, 2024.
We are also planning to advance NV-387 into a Phase II clinical trial for treatment of RSV infection in adults as part of the regulatory process required for registration of the drug for the treatment of pediatric RSV infection.
We plan on advancing the regulatory processes for NV-387 registration for other indications such as influenza and COVID via partnerships and non-dilutive funding.
As we meet the milestones, we believe we will be able to raise financing for further regulatory activities for NV-387 registration via non-dilutive grant funding, partnership revenues, as well as equity-based funding.

NanoViricides Advances NV-387 Antiviral Drug, Prepares for Phase II Clinical Trials for RSV and MPOX Treatment

NanoViricides shares are trading higher after the company announced it obtained a right of first refusal for all antiviral drug developments from TheraCour Pharma.

NanoViricides, Inc. (NYSE American.:<a href="https://pr.report/2zzd">NNVC</a>) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, reports today that it has now obtained a right of first refusal (ROFR) for all antiviral drug developments from the R&amp;D firm TheraCour Pharma, Inc. ("TheraCour").
NanoViricides has signed a broad Memorandum of Understanding Agreement (MoU) with TheraCour encompassing all antiviral drugs developments on September 23, 2024, an important step that provides the Company certain intellectual property rights for developing treatments against any viral infections.
NV-387, the Company's lead drug, is proving to be a revolutionary drug that has demonstrated strong effectiveness, surpassing existing drugs, against a number of distinctly different types of viruses in animal studies. With this MoU in place, the increasing number of antiviral indications of a broad-spectrum drug such as NV-387 can be quickly and easily discovered and added by the Company to its portfolio of drugs in its development pipeline.
In addition to NV-387, certain "Trojan Horse" drugs that can completely cure most viral infections by attacking the virus lifecycle in multiple ways have been developed by the Company. This MoU expands NanoViricides Inc's abilities to opportunistically and rapidly develop such drugs to treat viral infections of public health importance, even for those viruses that don't exist today and cannot be predicted.
The new MoU provides NanoViricides with the ability to rapidly progress in such new endeavors and provides the important intellectual property rights to further develop multiple drug candidates towards a multitude of antiviral applications, many of which may have been previously considered to be intractable.
The MoU also codifies the process by which the two parties negotiate licenses to specific antiviral fields. As in the past, a license would not be restricted to a single drug, but rather would encompass all drugs that can be conceivably applicable with the R&amp;D performed against the licensed field of antiviral application.
The revolutionary nanoviricide technology resulting in host-mimetic, direct-acting antiviral drugs is opening up a new era of treating viral infections just as penicillin opened up a new era and revolutionized the treatment of bacterial infections, enabling "one drug - many bugs" model instead of the current "one bug - one drug" model. NV-387, an example of the capabilities of nanoviricide technology, was developed in 2020 in response to the COVID pandemic and has completed a Phase I human clinical trial successfully. The Company is now planning for NV-387 to enter into Phase II clinical trials for evaluation of its efficacy against several viral diseases that include RSV, Influenza, Bird Flu, COVID, as well as MPOX/Smallpox infections.

NanoViricides Secures First Rights To TheraCour's Antiviral Developments, Eyes Phase II Trials For Lead Drug

NanoViricides, Inc. <a href="https://pr.report/1ws6">(NYSE:</a><a href="https://www.benzinga.com/stock/NNVC#NYSE">NNVC</a>) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, reports today that it is investigating the possibility of using NV-387 for the treatment of MPOX patients under the WHO MEURI protocol, in light of the recent WHO PHEIC (Public Health Emergency of International Concern) declaration for the current 2024 MPOX outbreak that is rapidly spreading into more than ten countries in Africa with additional cases detected in Thailand and Sweden.
MEURI, i.e. Monitored Emergency Use of Unregistered and Investigational Interventions, is an ethical protocol developed by the World Health Organization to evaluate the potential use of experimental drugs in the event of public health emergencies (<a href="https://pr.report/1wrz">https://en.wikipedia.org/wiki/Monitored_Emergency_Use_of_Unregistered_and_Investigational_Interventions</a>).
The Company believes that the MEURI protocol may be applicable for the evaluation of NV-387 for the treatment of MPOX infection in patients. NV-387 has completed Phase I clinical trial for safety and tolerability studies in healthy subjects with no adverse events reported indicating excellent safety and tolerability. NV-387 has demonstrated strong improvement in survival in animal model studies matching that of the currently approved drug, tecovirimat, indicating excellent effectiveness. MPOX Clade 1/1b require development of new therapeutics due to limitations of existing therapies.
<figure class="table"> 
<table>
<tbody>
<tr>
<td colspan="4">Survival Lifespan of Lethally Infected Mice - Intradigital Skin Footpad Infection with Ectromelia Virus (Model for MPOX, Smallpox)</td>
</tr>
<tr>
<td>Treatment</td>
<td>Survival, Days</td>
<td>Increase in Survival, Days</td>
<td>Increase in Survival, %</td>
</tr>
<tr>
<td>NV-387, Oral</td>
<td>14</td>
<td>6</td>
<td>75%</td>
</tr>
<tr>
<td>Tecovirimat, Oral</td>
<td>14</td>
<td>6</td>
<td>75%</td>
</tr>
<tr>
<td>NV-387-m-T, Oral</td>
<td>17</td>
<td>9</td>
<td>112.5%</td>
</tr>
<tr>
<td>Vehicle</td>
<td>8</td>
<td>0</td>
<td>0%</td>
</tr>
</tbody>
</table>
</figure>
Additionally, the Company has also found that NV-387 was superior to or equivalent to existing drugs in non-clinical animal trials in the case of three major classes of respiratory viruses: RSV, Influenza, and COVID; the so-called "triple-demic" respiratory viruses. The Company believes that NV-387, as a single broad-spectrum antiviral drug that can treat a large number of viruses, could be as revolutionary for the treatment of viral infections as penicillin was to bacterial infections, when its effectiveness is proven in human clinical trials.

NanoViricides Considers NV-387 for MPOX Treatment Under WHO Protocol Amid Global Outbreak

Press Releases

Broad-Spectrum Antiviral Drug NV-387 Cleared for Phase II Clinical Trial Application by the National Ethics Committee of the Democratic Republic of Congo

Measles Cases Are Increasing Globally; MPox Continues to Be a Threat - Broad-Spectrum Antiviral Drug Could Be the Solution

NanoViricides, Inc. Has Filed its Quarterly Report:  Broad-Spectrum Antiviral NV-387 To Combat MPox Pandemic in Africa -  Phase II Clinical Trial Update, Also Readying to Combat Measles Outbreaks, and to Tackle Bird Flu

The New Rational FDA COVID Vaccine Policy is Long Overdue, Says NanoViricides' Dr. Diwan

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NanoViricides to Present at the BIO International Convention in Boston on  Monday, June 16, 2025

NanoViricides (NNVC) to Unveil 'Escape-Proof' Antiviral Platform at Major Biotech Convention

NanoViricides Measles Drug Development Animal Study is Imminent

With Rising Variants of COVID and Bird Flu, the Single Broad-Spectrum Antiviral NV-387 Would be the Best Partner for Preparedness, Says NanoViricides' Dr. Diwan

There is a Strong Business Case for Phase II Clinical Program for Treatment of MPox Infection Using NV-387, an Industry-Leading Broad-Spectrum Antiviral Drug Candidate

Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387 is Almost Complete, Reports NanoViricides

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NanoViricides (NASDAQ: NNVC) Hits Key Milestones For Its Virus-Fighting Drug Candidate NV-387 In 2023; More To Come This Year

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