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NanoViricides Files Quarterly Report for Period Ending 2016-09-30
NanoViricides, Inc. (AMEX:NNVC)
Intraday Stock Chart
Today : Tuesday 15 November 2016

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SHELTON, Conn., Nov. 15, 2016 /PRNewswire/ -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), filed its quarterly report for its first quarter of financial year 2017 in a timely manner with the Securities and Exchange Commission on Monday, November 14th. The submission can be downloaded from the SEC website at SEC.gov | Home.

Targeted Virus-Killing Nanomedicines
NanoViricides reported that it had approximately $22.1 Million (M) of current assets (cash, cash equivalents, and prepaid expenses) as of September 30, 2016, the end of the reporting period. The net cash used in operating activities during this quarter was approximately $2.2M.

The Company's research and development (R&D) expenditure has increased as we advance towards human clinical trials. The Company estimates the current quarterly cash expenditure rate to be about $2.2M per quarter. Shareholder equity stood at approximately $23M for the quarter (unaudited figures). The Company estimates that it has sufficient cash in hand to last more than one year of operations at the current rate of expenditure.

The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of at least one of our drug candidates. The Company's expenditures during the reported period were on track with this expectation.

The Company has eight different drugs in development, including four indications in the HerpeCide program. This deep and wide pipeline demonstrates the robustness of the nanoviricide® platform technology. Of these, the Company is currently focused on moving our topical drug candidates against different herpesvirus indications into human clinical trials as soon as possible.

In the HerpeCide™ program, the Company is currently developing drugs against four different topical indications, namely: (a) skin cream/lotion for the topical treatment of "cold sores" (typically caused by HSV-1); (b) eye drops/gel for the treatment of ocular herpes keratitis (mostly caused by HSV-1, sometimes by HSV-2 primarily in neonates); (c) skin cream/lotion for the treatment of "genital lesions" caused by herpesvirus (typically HSV-2); and (d) skin cream/lotion for the treatment of shingles (caused by HHV-3 also known as VZV, i.e the chickenpox virus).

We believe that our skin cream for the topical treatment of shingles outbreak could be the first nanoviricide® drug candidate to enter human clinical trials in the very near future. The Company is currently performing studies needed to finalize a clinical drug candidate out of several that have shown strong success in cell culture studies. There is no standard animal model for shingles.

NanoViricides has engaged Professor Moffat's Lab at the State University of New York Upstate Medical Center (SUNY-UMC) in Syracuse for studies of these shingles drug candidates in cell culture and in a human skin patch model of VZV infection. We believe that these human skin patch studies should be highly predictive of human clinical trials success.

Other topical drugs in our HerpeCide™ program are variants of the shingles drug further optimized for the specific herpesvirus and topical delivery constraints. These topical treatments are expected to provide a significantly faster path to human clinical stage than injectable drugs.

Topical treatments for the herpesvirus indications are important. Although the herpesviruses stay latent in a nerve ganglion, the pathology of an outbreak in a patient begins with reinfection in the skin layer from the reactivated virus, followed by further expansion of the virus in the skin layer. The newly produced virus then causes additional spread of the virus to more nerve cells, and would become latent there. Topical nanoviricide® treatment would stop further expansion of the virus at the site and therefore should also potentially decrease further recurrences. Also, topical treatment allows exposure of the virus to much higher concentrations of the drug locally, and thereby should produce greater effectiveness with less overall drug use, as compared to systemic treatments.

There is no effective treatment for shingles and the shingles related PHN (post-herpetic neuralgia). The shingles associated debilitating pain usually lasts during the infection outbreak in most patients, But in some patients, PHN can develop, which can last 90 days to even a year in some cases after the skin has healed. Approved treatments for shingles and PHN include acyclovir related nucleoside analogs that are given in very high doses systemically for a week but with limited effect. A new nucleoside analog called FV-100 is in Phase 3 clinical trials. FV-100 development was previously abandoned by Bristol-Myers-Squibb and is now undertaken by a small pharma.

There is also a vaccine for shingles that may reduce occurrence of shingles as a preventive, but not as a treatment after an outbreak occurs. Another vaccine is in development. The chickenpox vaccine is now standard for children. However, the incidence of shingles in adolescents and young adults is rising, although shingles generally occurs in older people due age related decrease in immune function, and in patients with immune function compromising conditions from stress to organ transplant to other infections and HIV/AIDS.

Although in most patients shingles is debilitating during the outbreak but not life-threatening, in a small percentage of patients, it can cause eye infections that can lead to blindness.

There is no topical treatment for shingles. We believe this is an unmet medical need. The market size for a successful topical treatment for shingles could be in the billion dollar range.

NanoViricides, Inc. is one of a few bio-pharma companies that has all the capabilities needed from research and development to marketable drug manufacture in the small quantities needed for human clinical trials. Our new campus at 1 Controls Drive, Shelton, CT, has state of the art nanomedicines characterization facilities that enable us to perform IND-enabling nanomedicine analysis and characterization studies of any of our various drug candidates in house.

All of the biological testing and characterization of our drug candidates continues to be performed by external academic or institutional collaborators and contract research organizations (CRO). However, we now have our own capabilities to perform initial cell culture based drug candidate screening for BSL2 viruses, which includes herpesviruses. We believe that this is speeding up our drug development programs against such viruses significantly by removing the latencies of external testing in the earlier drug screening and the later drug optimization stages.

The Company has established additional collaborations towards IND-enabling development of drug candidates against the four HerpeCide program indications listed above. We now have collaboration agreements with the CORL at the University of Wisconsin, and the Campbell Lab at the University of Pittsburgh, for the evaluation of its nanoviricides® drug candidates in models of ocular herpesvirus and adenovirus infections. TransPharm Preclinical Solutions, a CRO, will continue to perform testing of our anti-herpes drug candidates in dermal infection models. In addition, we have a collaboration with Professor Moffat Lab at SUNY-UMC to study our drug candidates against shingles.

The nanoviricides® mechanism of action is believed to mimic a natural host cell receptor using which the virus binds and infects cells; binding of a nanoviricide nanomicelle to the virus is expected to render it non-infectious. A nanoviricide would thus stop the spread of the viral infection to new uninfected cells. This mechanism is different from that of currently available anti-Herpesvirus drugs. The Company therefore believes that it is able to develop broad-spectrum anti-herpes nanoviricide drugs.

About NanoViricides:
NanoViricides, Inc. (NanoViricides Inc: A New Era in Targeted Anti-Viral Therapeutics) 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. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
 

BigNick

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segnalata dal Chav, provo ad anticipare, entrato a 7,33 a chiusura gap, non so cosa faccia sinceramente

Vedi l'allegato 2689687

macd sta incrociando al ribasso, speriam di no, RSI quasi scarico, qualcuno conosce il motivo degli spike ?
 

pierlala

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segnalata dal Chav, provo ad anticipare, entrato a 7,33 a chiusura gap, non so cosa faccia sinceramente

Vedi l'allegato 2689687

macd sta incrociando al ribasso, speriam di no, RSI quasi scarico, qualcuno conosce il motivo degli spike ?

Sempre anti-Covid-19
NanoViricides Develops Highly Effective Broad-Spectrum Drug Candidates Against Coronaviruses
 

BigNick

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questa tratta all NYSE American perchè risulta nella sezione OTCBB PINKSHEET ?
 

BigNick

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Vediamo se oggi si muove con questa news

NanoViricides Announces Completion of $10.2 Million Registered Direct Offering - Funds to Accelerate COVID-19 Drug Program and HerpeCide™ Program

NanoViricides Announces Completion of $10.2 Million Registered Direct Offering - Funds to Accelerate COVID-19 Drug Program and HerpeCide™ Program
•May 26, 2020
SHELTON, CT / ACCESSWIRE / May 26, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, announced today that it has raised $10.22 Million in gross proceeds from the sale of 1.4 million shares of common stock, and no warrants, at a price of $7.30 per share, in a previously announced registered direct offering (the "Offering").

Maxim Group LLC and Kingswood Capital Markets, a division of Benchmark Investments, Inc. acted as co-Placement Agents in connection with the Offering. The co-Placement Agents were paid a total cash fee of 8% of the gross proceeds, plus $75,000 for reimbursement of legal fees.

The net proceeds to the Company were approximately $9.327 Million, after deducting placement agent fees and other costs. The purchase price reflects a discount of 19.7% to the closing price of $9.09 on May 21st, 2020, when the Securities Purchase Agreement was entered into. The Offering closed on May 22, 2020.

"We have substantially improved our balance sheet with this Offering," said Meeta R. Vyas, CFO, adding, "The proceeds provide us with an additional runway of over a year at our current rate of expenditures."

The Company intends to use the net proceeds of approximately $9.327 Million, after deducting placement agent fees and other costs towards general business purposes. The purchase price reflects a discount of 19.7% to the closing price of $9.09 on May 21st, 2020, when the Securities Purchase Agreement was entered into. The Offering closed on May 22, 2020.

"This infusion of funds will help us accelerate our drug development to cure the SARS-CoV-2 infection that is causing the global COVID-19 disease pandemic," said Anil R. Diwan, PhD, President and Executive Chairman of the Board, adding, "The funds will also enable us to further advance our first drug candidate for Shingles through initial human clinical trials, and further advance additional HerpeCide™ program candidates against HSV-1 that causes cold sores, and HSV-2 that causes genital ulcers, towards clinical candidate selection."

The Company has recently announced (on May 12th) that its nanoviricides coronavirus drug candidates were highly effective against certain human coronaviruses, namely hCoV-NL63 and hCoV-229E, in cell culture studies, indicating broad-spectrum anti-coronavirus effectiveness. The Company has also announced on May 20th that these drug candidates were highly effective in combatting lethal lung infection by hCoV-NL63 in a rat animal model study. HCoV-NL63 uses the same ACE2 receptor as the SARS-CoV-2 virus causing the pandemic, and also exhibits similar disease pathology in human infections, albeit causing a much milder disease. HCoV-NL63 can be used in a BSL2 lab whereas SARS-CoV-2 currently requires BSL3/BSL4 labs. Therefore, the Company believes hCoV-NL63 serves as a useful model for drug development against SARS-CoV-2.

The Company believes that these results are significant and indicate that a clinical nanoviricide drug candidate, once selected, would be worthy of human clinical trials for curing SARS-CoV-2 infection that causes the COVID-19 spectrum of diseases. NanoViricides is one of a few biopharma companies with its own cGMP-capable drug manufacturing facility. The Company believes it will be able to manufacture thousands of doses in a short period of time at this facility.

Maxim Group LLC and Kingswood Capital Markets, a division of Benchmark Investments, Inc. acted as co-Placement Agents in connection with the Offering. The co-Placement Agents were paid a total cash fee of 8% of the gross proceeds, plus $75,000 for reimbursement of legal fees.

The Shares were issued pursuant to a prospectus supplement dated May 21, 2020 which was filed with the Securities and Exchange Commission (the "SEC") on May 22, 2020 in connection with a takedown from the Company's shelf registration statement on Form S-3, as amended (File No. 333-237370), which became effective on April 2, 2020 and the base prospectus dated April 2, 2020 contained in that registration statement.

A Current Report on Form 8-K was filed on May 22, 2020 with the SEC. The description of the Offering contained herein is qualified in its entirety by reference to this Current Report and attached Exhibits thereto.
 

BigNick

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Inizia a farsi interessante

NNVC.jpg
 

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