Is constantly trying to figure out what the h#ll he is doing.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Oh goody,... Another conference presentation,.... At least there is also a set of face-to-face meetings with "BIO One-On-One Partnering system" - whatever that is.
https://www.accesswire.com/758238/NanoViricides-Inc-to-Present-at-the-BIO-International-Convention-in-Boston-on-June-5th-2023-at-315pm-ET
NanoViricides, Inc. to Present at the BIO International Convention in Boston on June 5th, 2023 at 3:15pm ET
6:40 AM ET 5/31/23 | Dow Jones
SHELTON, CT / ACCESSWIRE / May 31, 2023 / NanoViricides, Inc. (NYSE Amer:NNVC) (the "Company"), announces that the Company's President, Dr. Anil Diwan, will be presenting a talk in person at the BIO International Convention in Boston on June 5th, 2023 at 3:15pm ET.
Event BIO International Convention
Dates June 5-8, 2023
Location Boston Convention & Exhibition Center (BCEC), Boston,
MA, USA.
Website https://www.bio.org/events/bio-international-convention
Event NanoViricides Presentation
Date June 5, 2023
--------------------------
Time 3:15pm ET
--------------------------
Location Room 104 B, BCEC
--------------------------
In addition to the conference presentation, Dr. Diwan has scheduled several meetings in the BIO One-On-One Partnering system.
Dr. Diwan will present the Company's Assets and current development stage. The following assets are listed in the Company's Profile in the BIO One-On-One Partnering system, with all of the descriptions listed being as anticipated by the Company:
NV-CoV-2: 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(R) micelle. Expected to deliver encapsulated APIs to virally infected cells projecting viral glycoproteins, sparing normal cells from toxic antiviral APIs.
About BIO (from their website, www.bio.org)
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.
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-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). 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-CoV-2 into Phase I/II human clinical trials.
NV-CoV-2 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-CoV-2 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(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 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 poxviruses and/or enteroviruses 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".
(1. Cagno V, Tseligka ED, Jones ST, Tapparel C. Heparan Sulfate Proteoglycans and Viral Attachment: True Receptors or Adaptation Bias? Viruses. 2019 Jul 1;11(7):596. doi: 10.3390/v11070596. PMID: 31266258; PMCID: PMC6669472.)
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
View source version on accesswire.com:
https://www.accesswire.com/758238/NanoViricides-Inc-to-Present-at-the-BIO-International-Convention-in-Boston-on-June-5th-2023-at-315pm-ET
Apparently somebody didn't like what they heard in the shareholders' meeting judging by the very abrupt ~7-8% drop.
I'll wait until I see what's in the transcripts and I assume that the company will post that sometime in the next couple of days.
A good interview - and I hope that the company can keep the timeline that he states at the end of the interview for meeting with the FDA and EU regulators this summer and then in this fall.
Thanks for posting this.
Phase I trials mostly are focused on 'safety' profiles and in testing out different dosages, so yeah - I think that's going to be the primary goal here as well. But some inkling of what other sorts of data they intend to collect and how they plan to use that data to (hopefully) design a more extensive Phase II would be nice to see ahead of time.
Hopefully just getting a Phase I trial going in India will be enough to 'goose' the share prices enough that we won't get as big of a dilution for existing shareholders, or that that's enough to encourage a trial partnership with some other bigger pharma for the herpes-cides.
I think your take here is correct KMBJN. I am cautiously optimistic that we might finally start to see something moving after way too many years of bupkis.
New Quarterly Report is out. Doesn't appear to have anything noteworthy that we didn't already kind of know. I'll have to read it in more detail later tonight when I have some free time.
Just get it done already and start the trial Diwan.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001379006/000141057823001235/nnvc-20230331x10q.htm
Yep - that's all good for future use, but it's not going to be of use to the company or shareholders until after they get the FDA approvals rolling.
In the long run, the fact that tumors responded favorably to Multikine - in general - is likely to lead to off-label use and to trials for other types of similar cancerous tumors. So the market isn't going to 'just' be H&N cancers. But again, nothing good happens until that first treatment is approved.
Get it rolling folks.
Well - they have said that was their goal, and that it was 'supposed' to happen sometime during 2023. It would appear that things are moving forward.
The part that I don't get here - why so far below the recent market value for shares?
A lot of words to say almost nothing of value this morning - Just get a clinical trial started already Diwan.
NanoViricides is Expanding its Broad-Spectrum Antiviral Program to Explore Further Antiviral Applications of its COVID Clinical Drug Ingredient
6:45 AM ET 4/25/23 | Dow Jones
SHELTON, CT / ACCESSWIRE / April 25, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, reports that it is exploring additional antiviral applications for NV-387, the active pharmaceutical ingredient used in NV-CoV-2, the Company's COVID clinical drug candidate.
NV-387 has been found to have broad-spectrum activity against all of the tested seasonal coronaviruses and SARS-CoV-2 in pre-clinical studies. This activity is thought to be because NV-387 was designed to mimic a well known feature on human cell surfaces, called "sulfated proteoglycans" that a large number of virus families bind to as the first step in infecting a cell (reviewed in ([1]) ). Therefore, it can be anticipated that NV-387 may possess significant antiviral activity against many other virus families in addition to coronaviruses.
Antibiotics such as penicillin attack the bacterial surface and thereby kill the bacteria. Similarly, NV-387 is designed to attack the viral surface and destroy the virus particle. Similar to antibiotics that possess a broad-spectrum to treat bacterial infections, NV-387 could be a much needed broad-spectrum, direct acting, antiviral agent to treat multiple different viral infections.
Having a safe and effective broad-spectrum antiviral agent such as NV-387 in hand would help combat future viral infection epidemics before they expand. This strategy should form a backbone of pandemic preparedness strategy, rather than reliance on vaccines and antibodies that have now been proven to be of limited durable utility.
Once NV-387 successfully undergoes Phase 1 Safety Clinical Trials, further applications of NV-387 to other diseases would be eligible to directly proceed to Phase 2 Efficacy Clinical Trials in many cases. This would save the Company a substantial amount of time and money investment to bring additional drugs against other viruses based on this platform forward towards approval, significantly improving the return on investment.
To this end, the Company has undertaken pre-clinical studies of NV-387 against a number of other virus families of interest. As previously announced, we are working on poxvirus family therapeutics including mpox based on NV-387. Further, we are also working on Respiratory Syncytial Virus (RSV), and plan to work on other viruses that cause lung infections, such as parainfluenza viruses, and human metapneumovirus. We plan to continue to add to this list with both internal and external efforts. Some of the other important viruses that are known to bind to sulfated proteoglycans include chickengunya virus (CHKV), human papillomavirus (HPV), Ebola and Marburg viruses (EBOV, MARV), Hendra and Nipah viruses, Rabies virus, Norovirus, and Rhinoviruses. There are no safe and effective treatments for most of these viruses at present.
A safe and effective broad-spectrum antiviral drug that can treat all segments of patient population remains an unmet medical need, not only for COVID, but also for many other viral infections including RSV. While there are other broad-spectrum antivirals available, their high toxicities (e.g. cidofovir, brincidofovir, ribavirin) or poor effectiveness (e.g. favipravir) severely limit their applicability. NV-387 could be in a unique position to fulfill this unmet medical need.
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 into 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 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.
ICH refers to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 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".
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
([1]) Cagno V, Tseligka ED, Jones ST, Tapparel C. Heparan Sulfate Proteoglycans and Viral Attachment: True Receptors or Adaptation Bias? Viruses. 2019 Jul 1;11(7):596. doi: 10.3390/v11070596. PMID: 31266258; PMCID: PMC6669472.
SOURCE: NanoViricides, Inc.
View source version on accesswire.com:
https://www.accesswire.com/750838/NanoViricides-is-Expanding-its-Broad-Spectrum-Antiviral-Program-to-Explore-Further-Antiviral-Applications-of-its-COVID-Clinical-Drug-Ingredient
Nothing new in it that we didn't already kind of know - but still a good read and a nice summary for those who might not be as familiar with CVM as those of us 'long-timer' longs.
Thanks for posting this.
Interesting trading day here today. I can't find any new news - so I am not sure what's driving things.
How does that old saying go - even a broken clock is right 2x a day,...
;)
Excellent questions Sir!
NanoViricides Has Shipped Drug Products for Impending Clinical Trials of NV-CoV-2, Its COVID Drug Candidate
6:45 AM ET 4/17/23 | Dow Jones
SHELTON, CT / ACCESSWIRE / April 17, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in nanomedicines against viruses, announced today that it has shipped the drug products for impending clinical trials of NV-CoV-2, its COVID drug candidate, to its collaborator, Karveer Meditech Pvt. Ltd., Kolhapur, India ("Karveer").
Karveer has already successfully obtained required regulatory permissions to conduct clinical evaluation of NV-CoV-2 as a COVID treatment in India. It has retained a well-regarded local Clinical Research Organization to conduct the NV-CoV-2 human clinical trials.
Even as U.S. President Joe Biden recently signed a resolution to end the COVID-19 emergency, SARS-CoV-2 continues to claim over 1,700 lives per week in the USA alone, in what is currently a "non-wave" period, claiming five times the number of lives taken by Influenza viruses. The SARS-CoV-2 virus with its continually evolving variants is now a continuously recurring phenomenon, like other seasonal viruses such as Influenzas.
The Company targets NV-CoV-2 to fulfill an important medical need that remains unmet even today. There is no antiviral COVID drug available yet that can be used for the treatment of all segments of patient population. Equally noteworthy, there is no antiviral COVID drug available yet that can be expected to continue to work even as new variants of the SARS-CoV-2 keep evolving and spreading in the field.
NV-CoV-2 is a broad-spectrum, pan-coronavirus drug that is unlikely to be overcome by SARS-CoV-2 variants, because of the very nature of how NV-CoV-2 is designed. It has been found to work against many unrelated coronaviruses in pre-clinical studies, supporting this expectation.
Additionally, the observed strong pre-clinical safety of NV-CoV-2 indicates that the drug would be applicable to treat disease in all populations from pediatrics to otherwise healthy adults to patients with co-morbidities. NV-CoV-2 has shown extremely strong safety in multiple pre-clinical animal models in both GLP and non-GLP studies. In particular, its extremely strong safety is seen in its NOAEL* value of 1,200 mg/Kg and MTD* value of 1,500 mg/Kg in rats. The drug was also found to be non-immunogenic and non-mutagenic. Further, there were no indications of possible allergy or injection-site reactions in any of the studies across multiple animal models.
NV-CoV-2 is expected to be available for the treatment of mild to moderate disease in two orally available forms, oral syrup and oral gummies to suit patients from pediatrics to healthy adults to patients with co-morbidities. It is expected to be available in an injectable form for the treatment of out-patients (i.e. non-hospitalized) with severe disease. It is also expected to be available in an infusion form as well as a direct lung inhalation form for the treatment of hospitalized patients with severe disease.
In contrast, currently approved antiviral drugs against SARS-CoV-2 have significant limitations on the segment of population in which they can be useful, severely restricting their applicability.
The NV-CoV-2 oral syrup and oral gummies drug products were shipped in preparation of impending human clinical trials. The human clinical trials are expected to commence soon in India with the drug being sponsored by the Company's licensee and collaborator, Karveer. NanoViricides recently announced that it executed a license agreement with Karveer giving it certain rights for the development, clinical evaluation, and commercialization of NV-CoV-2 and NV-CoV-2-R in India. NanoViricides would receive significant royalties upon commercialization.
* NOAEL = The no-observed-adverse-effect level (NOAEL) denotes the level of dose at which there is no biologically or statistically significant increase in the frequency or severity of any adverse effects compared to appropriate control. MTD = The maximum tolerated dose, is defined as the highest dose of a drug that does not cause unacceptable side effects or overt toxicity in a specific period of time.
About Karveer Meditech Private Limited
Karveer Meditech Private Limited is a small and aspiring dynamic pharmaceutical company in India. It has developed and commercialized in local markets more than a dozen different generic and semi-branded pharmaceutical drugs as well as Ayurvedic medicines and vitaminized nutritional supplement protein powder products. It was co-founded by Dr. Anil Diwan, who serves as a Director and is a passive investor. Dr. Diwan is also co-founder of and President and Executive Chairman of the Board of NanoViricides. Karveer Meditech is independently managed by its Managing Director in India
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-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 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 into 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 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.
(MORE TO FOLLOW) Dow Jones Newswires
April 17, 2023 06:45 ET (10:45 GMT)
Your opinion has been noted, examined, and tossed into the rubbish bin as is appropriate.
Because this position in CVM, and in a few other biotech/pharma stocks that I hold is a very small fraction of what I have invested in the market. I'm not betting $s that I need for anything else.
Almost all of my investments (retirement and taxable accounts) goes into low-cost & dumb index funds, ETFs & a set of dividend yielders that I like & add to regularly. I'm not a trader. I have plenty of time for a boom/bust opportunity like CVM to get it done.
You-all appear to assume that you have the only viable way to 'win' in the market. Even as up & (mostly) down market in 2022 I ended up about even overall while steadily adding to a lot of my positions.
Agreed,....
Fine with me - gives me more time to add some shares at low prices in the meantime.
Up 11+% today, but I wonder how long that's going to hold up.
IF they actually start a trial, THEN I think that the NNVC stock price might jump quite a bit more. But I'll believe that when I see it at this point.
Yep - not surprising at all that Diwan would self deal. He's really good at that.
I'm just glad 'something' is moving forward at last, even IF he's going to line his pockets a bit more on the way. I would be happy to make a bit of my own old dead investment here back.
It about time - And good to see ANY sort of movement forward. And yes - I did read the previous posts here from last night before posting this. I assume this means that they 'could' move forward with the anti-Herpes treatments "someday" as well.
NanoViricides Signs a License Agreement That Includes Clinical Evaluation of Its COVID-19 Drug Candidates
7:45 AM ET 4/4/23 | Dow Jones
SHELTON, CT / ACCESSWIRE / April 4, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a global leader in nanomedicines against viruses, announced today that it has executed a License Agreement with Karveer Meditech Pvt. Ltd., Kolhapur, India ("Karveer").
Under this Agreement, Karveer has the right to commercialize the Company's COVID drugs NV-CoV-2 and NV-CoV-2-R in India. To enable commercialization, Karveer has undertaken Clinical Development and Evaluation and is sponsoring these two drugs in India for this purpose.
Karveer has represented to NanoViricides that it has successfully obtained required regulatory permissions to conduct clinical evaluation of NV-CoV-2 as a COVID treatment in India.
"The human clinical trials of NV-CoV-2 are expected to begin soon in India with the drug being sponsored by our collaborator, Karveer," said Anil R. Diwan, PhD, President and Chairman, adding, "This is an important milestone in the life of NanoViricides. We have been working diligently towards this goal."
NV-CoV-2 is a first-in-class drug that acts by a novel mechanism of action. The Company calls its mechanism "Re-Infection Blocker". "A re-infection blocker directly attacks the virus particle with a multi-pronged attack and disables the virus completely, a task that no other current class of drugs we are aware of is known to accomplish," says Dr. Diwan, adding, "If approved for use, of which there can be no guarantee, NV-CoV-2 could become a strong weapon in the continuing fight against COVID which is now believed to be turning into an endemic disease like influenza."
Under the License Agreement, NanoViricides has granted Karveer a limited, non-transferable, exclusive license for commercialization of NV-CoV-2 and NV-CoV-2-R in India. Karveer will conduct clinical evaluation of the drugs as necessary in adherence with regulations in India, including ICH guidelines, as a part of its development and commercialization efforts in India. NanoViricides will have full rights to the data generated in the clinical trials, and may use this data internationally as needed. For this purpose, NanoViricides will reimburse Karveer for all direct and indirect costs and a development fee of 30% of such costs, and any applicable taxes. Upon commercialization, NanoViricides will receive a royalty of 70% of final invoiced sales.
Previously, on September 15, 2021, NanoViricides signed a Master Services Agreement with Karveer in which Karveer declared its intent to license NV-COV-2 and NV-CoV-2-R for commercialization in India, and undertook the responsibility to obtain necessary licenses and regulatory approvals as would be needed for the clinical evaluation and commercialization of the drugs in India. No binding licensing activity took place under that earlier agreement.
What is different about NV-CoV-2
NV-CoV-2 is designed to completely destroy the virus particle, by binding it at multiple points, and then coating it and fusing with it. This proposed activity of a nanoviricide defines a new class of drugs, that the Company calls "Re-Infection Blocker". This activity contrasts with two well-known antiviral drug classes, namely (Neutralizing) Antibodies, and (Small Molecule) Entry Inhibitors. Antibodies attack the virus particle only with two binding points, and tag the virus for identification and further processing by the patient's immune system. Viruses that cause severe infection and pathology, including SARS-CoV-2 (that causes COVID) have evolved multiple pathways for disrupting the patient's immune system. Also, antibodies are very specific to the virus variant, and are readily overcome by the virus as it evolves into new variants. This has been witnessed most starkly in the COVID pandemic, wherein all of the previously approved antibodies have lost their Emergency Use Authorizations as their effectiveness has diminished significantly with new virus variants that evade them emerging rapidly. The other related class is that of entry inhibitors, which are small molecules. Each such molecule can only occupy one of the hundreds of cell-binding points on the virus surface, leaving the virus still capable of infecting a cell. Only a few small molecule entry inhibitors have become successful drugs but with limited effectiveness. NanoViricides technology does not have these shortcomings.
A Form 8-K "Current Report" regarding this Agreement was filed with the SEC on Friday, March 31, 2023 (https://www.sec.gov/ix?doc=/Archives/edgar/data/1379006/000110465923040296/tm2311179d1_8k.htm).
About Karveer Meditech Private Limited
Karveer Meditech Private Limited is a small and aspiring dynamic pharmaceutical company in India. It has developed and commercialized in local markets more than a dozen different generic and semi-branded pharmaceutical drugs as well as Ayurvedic medicines and vitaminized nutritional supplement protein powder products. It was co-founded by Dr. Anil Diwan, who serves as a Director and is a passive investor. Dr. Diwan is also co-founder of and President and Chairman of the Board of NanoViricides. Karveer Meditech is independently managed by its Managing Director in India.
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(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-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 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 into Phase I/II human clinical trials.
NV-CoV-2 is our nanoviricide drug candidate for COVID. NV-CoV-2-R is our other 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 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.
(MORE TO FOLLOW) Dow Jones Newswires
April 04, 2023 07:45 ET (11:45 GMT)
You are probably correct - but it's never a 'foregone conclusion' until it is actually a conclusion.
A bit of news - Citius extends gains on advancing efforts to spin off oncology asset
https://seekingalpha.com/news/3952716-citius-stock-gains-on-spin-off-plans-for-oncology-asset
Mar. 30, 2023 9:29 AM ET
Citius Pharmaceuticals, Inc. (CTXR)
RDY
By: Dulan Lokuwithana, SA News Editor
After a 7% rise in the previous session, Citius Pharma (NASDAQ:CTXR) shares continued to gain in the pre-market Thursday after the company highlighted progress on its previously announced plans to spin off oncology candidate I/ONTAK into a standalone publicly-traded entity.
In a press release on Thursday, Citius (CTXR) said that in connection with the transaction, it has selected Maxim Group LLC as the financial advisor to its wholly-owned subsidiary, Citius Acquisition Corp.
Following the spinoff, Citius (CTXR) is expected to continue to trade on the Nasdaq under its current ticker CTXR.
I/ONTAK is a reformulation of the previously FDA-approved oncology treatment ONTAK which was available in the U.S. market from 1999 – 2014 but voluntarily withdrawn later.
Citius (CTXR) and Dr. Reddy's (RDY) have a licensing deal for I/ONTAK, which is currently under FDA review for persistent or rare blood cancer recurrent cutaneous T-cell lymphoma (CTXR), with a decision expected by Sept. 28, 2023.
Read: Seeking Alpha contributor Bret Jensen issued a Hold rating on CTXR, noting that the upcoming FDA decision on I/ONTAK is a binary event.
Yeah - I don't really pay much attention to what goes on here at this stage, other than paying attention to news and alerts.
Whatever. Nothing matters too much to my endgame here with CVM other than finally hearing that their BLA meetings and application is underway. Until then, the share prices are going to bounce around up and down a lot.
The "New Data" is a bit misleading IMO. They haven't had any 'new data' since they hit their 298 deaths endpoint and achieved data-lock. Some new analyses of old data maybe, or perhaps some follow-up data discussing changes in tumor pathology?
Tick tok - Let's see them get whatever remaining validation of the expanded production facility done so that they can actually get their BLA delay excuses removed.
Agreed.
Fairly evenhanded article on Seeking Alpha this morning - a good read.
https://seekingalpha.com/article/4583270-citius-pharmaceuticals-stock-balanced-risk-reward-near-term-catalysts
Was their positive news? If so - I haven't seen it.
Luckily, I never bought into the hype over INO several years ago because too much seemed to be up in the air, or conveyed in a 'fluffy' and inexact manner. Kept following them though at a distance.
What little INO that I do hold I have at a cost average of ~$1.70/share, and I have only had for about 2-3 months. Seems a fair price for a company that might have themselves a successful Phase I/II trial completion under their belt. If I am wrong, I am not in too deep or overextended.
Something might still pan out for their COVID vaccine with that Chinese partner and INO is no longer footing the bill for the trials in the meantime. And their Phase I/II trial data for their glioblastoma trial last spring was interesting as well.
That being said - past management was definitely not always honest with shareholders and played very fast and loose.
Yeah, what do I know? I have only been investing in individual stocks, ETFs and index funds on my own, quite profitably, for at least 15 years. That excludes the additional 10 years prior working strictly within my employer-supported 501k equivalent.
If you don't understand why the strategies of others works for them, then you shouldn't have asked.
Your points are noted - but they are irrelevant to the investing strategy I chose to use.
I do invest enough to 'matter'. I just spread it around and don't depend on any one thing or subset of things to take off in order to be successful.
Price of any investment - including a penny stock - only matters on two days. The day you buy (low). The day you choose to sell (higher). Short-term ups and downs are irrelevant. 90-95% of my investment dollars goes into fairly run of the mill stuff, dividend generators, index funds and such.
Perhaps you should stick to what you think works and let those of us with other strategies and plans do what we think works. I've got the consistent returns and growth, even in a down year like the last one was.
Mmmmmmk?
Mr. Market appears quite happy with CVM today. Perhaps folks interpreted what was in the report a couple of days back far more optimistically than do some of the posters on this message board?
Indeed. I have been on this board since about then (2010). However, I didn't ramp up my buying here until after they had completed their Phase III and almost everything I hold was bought post their last R/S.
In the meantime, what I hold here of CVM is a very small amount of what I have invested elsewhere in the markets. I hold some of several such stocks in biotech/biomed - figuring that if those stocks pay off I do very well. And if they go bust I am not out that much and the rest of my - more boring and predictable - investments are where I put most of my investment $$s anyway.
As I said - I don't need any one thing to work out in the short-term - because I don't think or act in the short-term.
And your point would be what exactly Mr. fung_derf?
Doesn't change my status, my cost basis, or my decision making as a long.
And as I said - my other investments are proceeding nicely in the meantime since they are all long-term plans. I don't need any one thing to work out in the short-term.
Why would I be upset? My cost basis doesn't change and I might even use the down-time to add some more inexpensive shares, and hold them until I get long-term capital gains tax levels.
Patience and time,.... patience and time,...
In the meantime I keep doing what I do with my other, less speculative investments and dividend producers.
Good news? I'm not a subscriber to Briefing.com, so I can't link to the actual full article.
NOVIO Announces Positive Preliminary Results from Second Cohort of Phase 1/2 Trial with INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis
8:02 AM ET 2/16/23 | Briefing.com
PLYMOUTH MEETING, Pa. , Feb. 16, 2023 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, today announced positive preliminary results from the second cohort of its Phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV 6 and HPV 11-associated Recurrent Respiratory Papillomatosis (RRP) in adults. In the second cohort of 11 patients who were administered INO-3107 via the exploratory side port needle, 10 of the 11 patients (91%) saw a reduction in surgical interventions in the year following initial treatment, with measurement beginning at Day 0, the start of trial therapy. Of these 10 patients, four did not require surgery. There was a statistically significant median decrease of three surgical interventions when comparing the year following treatment to the year prior. In the year prior to treatment, the number of surgical interventions for these 11 patients ranged between 2 and 8, and the median was 5. INO-3107 was well-tolerated and immunogenic among patients in the second cohort. The safety and efficacy results for the second cohort were consistent with results announced for the first cohort in October 2022.
Indeed - the wording is - as usual - squishy and weaselly.
And he was hedging his bets and statement quite a bit in the "Recent Developments" section as well.
For Example:
Some Highlights From the 10Q – Here’s hoping Diwan isn’t just blowing smoke – for a change:
From Page 9:
The Company believes that it has several important milestones, including Phase 1 clinical trials for the Company’s broad-spectrum, pan-coronavirus drug NV-CoV-2, that should occur in the ensuing year. Management believes that as it achieves these milestones, the Company’s ability to raise additional funds in the public markets would be enhanced.
From Page 18:
We have several drugs in our pipeline. Of these, two drugs developed to combat the COVID-19 pandemics, namely NV-CoV-2 and NV-CoV-2-R, are our most advanced drug candidates. We believe that the essential preclinical work including GLP Safety/Toxicology studies has been completed for taking NV-CoV-2 into human clinical trials evaluation. We are working diligently towards the goal of filing an Investigational New Drug Application (IND) for NV-CoV-2 as soon as possible. We are also working towards the goal of starting clinical trials outside of the USA for this drug. We believe that once Phase I clinical trials of NV-CoV-2 are successful, both NV-CoV-2 and NV-CoV-2-R can enter Phase II and further clinical studies. We have successfully made oral formulations of NV-CoV-2 as both (i) NV-CoV-2 Oral “Gummies” and (ii) NV-CoV-2 Oral Syrup. In addition, we have developed the injectable formulation, (iii) NV-CoV-2 for Injection, Infusion or Inhalation. The other drug, NV-CoV-2-R comprises NV-CoV-2 with remdesivir encapsulated in the belly of the polymeric micelles. The clinical program is expected to start with evaluation of the NV-CoV-2 Oral Syrup and NV-CoV-2 Gummies in adults, with extension to pediatric populations upon success. Clinical trials of the
Continued to Page 19:
Injectable Formulation of NV-CoV-2 are expected to follow thereafter. We will report on these objectives via press releases as meaningful advancements take place.
On Page 20:
Since completing the IND-enabling safety/toxicology studies, the Company has successfully developed orally active formulations of our drug candidates, in an oral syrup form, as well as an oral gummies (“Chewable Gel”) form. We believe that for mild to moderate cases, for pediatric, and older patients, the oral syrup and gummies forms would be highly advantageous over tablets, capsules, injections, infusions, or lung inhalations. The injectable formulation is expected to be valuable in the treatment of severe cases. Further, this formulation is designed to be deliverable as an aerosol by a simple hand-held device directly into lungs. Such inhalation, as an aerosol is expected to provide greater benefits to more severe patients by providing high concentration of the drug locally in the lungs where the SARS-CoV-2 viruses cause the most damage. We are working with advice from a clinical research organization and external consultants and collaborators on developing the initial human clinical studies plan and application documents. Simultaneously, we are working on putting the various agreements together as necessary. A clinical trial application for evaluation of oral administration of NV-CoV-2, as well as most of the associated agreements have been completed for one of our initiatives outside the USA. We expect to announce the resulting collaborations once the formal steps are completed.
On Page 21:
Recent Developments
During the three months ended December 31, 2022, we have been compiling and performing medical writings needed for developing an IND application to the US FDA for human clinical trials of NV-CoV-2 in COVID-19 patients. We have also been compiling and performing medical writings that would be needed for international applications for clinical trials under the ICH and regulatory guidelines of certain countries. As a result, a clinical trial application for evaluation of oral administration of NV-CoV-2, as well as most of the associated agreements have been completed for one of our initiatives outside the USA. We expect to announce the resulting collaborations once the formal steps are completed. Additionally, we have scaled up the processes for the cGMP-compliant manufacture of the active ingredient (“drug substance”) NV-387 that goes into NV-CoV-2 drug product formulations to approximately 5 Kg final production scale. We have also performed additional experimental work resulting in substantial improvements in some of the production steps. We have improved or generated the required documentation for many of the activities. We have begun manufacture of clinical supply of the drug substance NV-387 at the 5 Kg production scale. It is expected that the 5Kg scale would be sufficient to treat approximately 1,000 patients, although the actual required dose for efficacy will only be established in clinical trials.
I could definitely live with that number,.... :D