WEST HAVEN, Conn.--(EON: Enhanced Online News)--NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), reports that it has filed its financial year end annual report (Form 10-K) with the Securities and Exchange Commission (SEC) on Monday, September 30, 2013. The report can be accessed at the SEC website (http://www.sec.gov/Archives/edgar/data/1379006/000114420413053084/0001144204-13-053084-index.htm).
“We have significantly improved our Corporate Governance and have achieved up-listing to NYSE-MKT, as we build a strong Company”
The Company had approximately $13.9M cash in hand and an additional approximately $1.5M in prepaid expenses and security deposits at the end of the reported period, June 30, 2013, as compared to a cash and cash equivalents balance of approximately $14.3 Million one year ago. Research and development expenses for this year were approximately $4.30M compared to $4.27M for the year ended June 30, 2012. General and administrative expenses increased to $3.21M for the year e7nded June 30, 2013, from $1.82M for the previous year.
Subsequent to the reporting period, on September 10, 2013, the Company performed a uniform reverse split of its securities on a 3.5 to 1 basis, reducing its authorized common stock from 300,000,000 of our old shares to 85,714,286 shares of the new common stock, under the new CUSIP number 630087203. The Company undertook this reverse split in order to meet the stock price criteria for listing on certain national exchanges.
On September 10, 2013, the Company raised approximately $10.3M in a registered direct offering of our post-split securities to accredited equity investors and other institutions. The Company reported that one of its directors, Dr. Milton Boniuk, invested $3M in this raise. Dr. Boniuk made these investments both personally as well as from his charitable foundation and other interests.
The Company estimates that its total cash and cash equivalent holdings after this raise are now sufficient for taking a drug candidate through initial human clinical trials. These estimates are based on several assumptions including the cost estimates provided by certain clinical research organizations, and assumptions for the time various activities are estimated to take.
The Company now has six commercially important drug development programs in its pipeline, addressing a market size estimated to be in the range of $40 Billion to $70 Billion by various estimates.
In the past year, the Company has focused on three important objectives:
1. Advanced Pre-clinical development of our Injectable FluCide towards IND filing;
2. Enabling a highly customizable pilot-scale cGMP manufacturing capability for the production of clinical study quantities of any of its nanoviricides® drug candidates and any of the various formulations of these candidates;
3. Improving Corporate Governance towards up-listing the Company on a national exchange.
The Company reported that it has been successful in advancing each of these objectives. On September 25, 2013, the Company stock was listed and began trading on the NYSE MKT national exchange.
The Company has signed a Memorandum of Understanding (MOU) with Inno-Haven, LLC, for the total renovation of the 1 Controls Drive, Shelton, CT, facility purchased by Inno-Haven into a pilot scale cGMP facility and associated R&D laboratory space. Inno-Haven is controlled by Anil R. Diwan, PhD, our founder. Inno-Haven has raised substantial amount of capital for this project through various sources, and it is expected that they will be able to raise all of the necessary funding for this project, with minimal capital expenses to be borne by NanoViricides, Inc. The Company is expected to lease the facility. The terms of the lease are expected to be negotiated after the total cost of the facility can be determined to a substantial extent. No lease has been signed yet. The project is already in construction phase, and is anticipated to be completed in the first calendar quarter of 2014, if no additional delays such as long lead times or back orders on equipment etc. are encountered.
We are currently focusing on advancing our Injectable FluCide™ drug, for the treatment of severely ill, hospitalized, influenza patients, towards an IND filing. We have also developed an Oral FluCide drug that continues to advance following the injectable version. Both of our FluCide drug candidates are “broad-spectrum”, i.e. they are expected to be able to combat most, if not all, influenza viruses, including bird flu, high path influenzas, epidemic influenzas, seasonal influenzas, and potentially any novel influenza A strains.
The Company is scaling up the production of FluCide from gram scale to several hundred grams scale. The Company believes that the scale up and reproducibility of product batches can be effectively controlled.
Recently, the Company’s DengueCide™ drug candidate has received an Orphan Drug designation from the US FDA. This designation provides significant economic benefits, including a “Priority Review Voucher” that can be employed to accelerate another drug development program of the Company or a collaborator. DengueCide is designed to be active against all four major serotypes of dengue viruses.
HIVCide™ is a drug in development against HIV/AIDS that shows the promise of becoming a “Functional Cure” against HIV/AIDS, based on available animal studies data in the standard humanized mouse model of HIV-1 infection in human T cells. This model is known to be predictive of successful anti-HIV drug development. Recently, the Company reported that it has further improved its HIVCide drug candidate(s) in an SAR (“structure-activity-relationship”) program.
The Company is also developing a single topical solution nanoviricide to attack most viral infections of the eye including Epidemic Kerato-Conjunctivitis (EKC) and Herpes Keratitis.
In addition, the Company has successfully developed initial drug candidates against Oral “Cold Sores” and Genital Herpes.
The Company has taken important steps towards improving our corporate governance this year. In May, 2013, we appointed Ms. Meeta R. Vyas, SB, MBA, a seasoned executive with public company experience, as our interim Chief Financial Officer (CFO). Previously, in June 2012, we had appointed Mr. Stanley Glick, CPA, as an independent Director of the Company and the Chairman of its Audit Committee. In June, 2013, we appointed two additional independent members to our Board of Directors, making our Board independent of our executives. Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology in the Alkek Eye Center at the Baylor College of Medicine, joined our Board on May 28, 2013, as an independent member of the Company’s Board of Directors. Mukund S. Kulkarni, Professor of Finance and Chancellor of Penn State University, Harrisburg, joined our Board on June 24, 2013, as an independent member of the Company’s Board of Directors.
The Company believes that it has a robust, strong, and wide drug pipeline that is advancing satisfactorily towards clinical trials.
“We have significantly improved our Corporate Governance and have achieved up-listing to NYSE-MKT, as we build a strong Company,” said Anil R. Diwan, PhD, President and Chairman of the Company, adding, “We have also made significant progress in enabling cGMP manufacture of our drug candidates, and have continued strong progress in advancing our six major drug candidates. We are steadily progressing towards the goal of approval of our drug candidates.”
“We currently enjoy the best financial position in the history of our Company,” said Eugene Seymour, MD, MPH, adding, “We are now confident that we will be able to take our first drug, FluCide, into human clinical trials on our own.”
On September 30, 2013, the Company has filed its Annual Report on Form 10-K for the period ended June 30, 2013 on September 30, 2013. However, the Registrant was unable to complete the financial statements in interactive data format in eXtensible Business Reporting Language (“XBRL”) without unreasonable effort or expense. We will amend our Form 10-K to provide financial statements in XBRL format within the time prescribed for the filing.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral 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.
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 pre-clinical 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.