WEST HAVEN, Conn.--(BUSINESS WIRE)--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 29, 2014. The report can be accessed at the SEC website (http://www.sec.gov/Archives/edgar/data/1379006/000114420414058463/0001144204-14-058463-index.htm).
The Company had approximately $36.7 million (M) cash in hand and approximately $1.9M in prepaid expenses and security deposits at the end of the reported period, June 30, 2014, as compared to a cash and cash equivalents balance of approximately $15.4M one year ago. Research and development expenses for this year were approximately $5.13M compared to $4.30M for the year ended June 30, 2013. General and administrative expenses were $3.54M for the year ended June 30, 2014, compared to $3.21M for the previous year.
We became eligible for listing on major US national stock exchanges as a result of steps taken in improving our executive team and corporate governance except for the stock price criteria. We performed a uniform reverse split of our securities, at a 3.5 to 1 ratio to attain full eligibility for up-listing, on September 10, 2013. Concomitantly, we also performed a registered direct financing of approximately $10.33 million, with net proceeds to the Company of approximately $9.6 million, after deducting expenses and fees.
The Company’s shares began trading on the New York Stock Exchange MKT on September 25, 2013, under the stock symbol, “NNVC”.
On January 24, 2014, we completed a registered direct offering and raised gross proceeds of approximately $20M before estimated expenses of approximately $1.2M, net proceeds of approximately $18.8 Million.
Subsequent to the reporting period, in July, 2014, the Company accepted a subscription in the amount of $5,000,000 for a 10% Series C Convertible Debenture from Dr. Milton Boniuk, a member of the Company’s Board of Directors, as reported previously.
Additionally, on September 5, 2014, we accepted warrant exercises for the purchase of an aggregate of 2,136,655 shares of the Company’s Common Stock for an exercise price of $3.50 per share for aggregate proceeds of $7,478,292. This warrant exercise corresponds to the old warrants for which we had filed a registration statement on Form S-3 on July 17, 2014, which became effective on August, 1, 2014. All warrants specified under this Form S-3 that were not exercised earlier, have now expired. No brokers or consultants were engaged and no commissions or fees were paid during this warrant exercise other than expenses.
With these transactions, we now have estimated cash in hand of approximately $48.6M. With this strong balance sheet, we now have sufficient funds in hand to advance our first drug, Injectable FluCide™, for treatment of hospitalized patients with influenza through at least the initial human clinical trials. In addition, given our current rate of expenditure, and projected low costs of clinical trials provided that FluCide is as successful in humans as it has been in small animals, we believe that we may have sufficient funds in hand to advance one more drug candidate into advanced preclinical and possibly first in human studies.
The Company has made significant progress in the production of its Injectable FluCide drug candidate for hospitalized patients with severe influenza. In particular, we have been able to successfully scale up the batch size to as much 200g in our current facility. This amount was determined to be sufficient to begin certain animal safety/toxicology studies. We anticipate this material to be shipped for these studies very soon. We have engaged BASi Toxicology Services, West Lafayette, Indiana, to perform our IND-enabling safety/toxicology studies.
We are happy to report that the construction of our state of the art, modern, cGMP capable, clinical scale, multipurpose, nanomedicines manufacturing facility at 1 Controls Drive, Shelton, CT, was completed in June, 2014, while managing customized equipment delivery schedules and some weather-related delays. We are now completing the special equipment fit-out modifications. We have contracted out the facility validation to a third party. Informally, we have started working in the new facility. Once the facility validation is complete, we intend to move most of our work in a phased manner over the next year or so to the new facility in order to minimize impact on our ongoing projects. The facility was built by Inno-Haven, LLC, which is managed by Dr. Anil Diwan, who is also our President and Founder. Dr. Diwan raised funding for this project from personal funds, certain sales of his NNVC founder’s stock under a 10b(5) plan in 2011, and loans and other borrowings from certain other private individuals over time. In 2011, Dr. Diwan took the risk of building a state of art nanomedicines manufacturing facility on his own, independently, with the intention of performing contract manufacturing for third parties as well as for NanoViricides. At that time, NanoViricides did not have the financial strength necessary for undertaking such a capital-intensive project. Later, in February, 2013, NanoViricides, Inc. signed a Memorandum of Understanding with Inno-Haven for the total renovation of the 1 Controls Drive, Shelton, CT, facility purchased by Inno-Haven into a pilot scale cGMP facility and R&D laboratory space as per NanoViricides specifications.
After NanoViricides had raised significant amounts of funds this year, and with input from expert consultants, in July, 2014, NanoViricides Board of Directors unanimously determined that it was in the best interests of the Company and its shareholders to acquire this state-of-the-art nanomedicines manufacturing facility from Inno-Haven. We anticipate executing and consummating a Contract of Sale for the facility with Inno-Haven in the near future.
The Company recently restarted our anti-Ebola drug development program, in response to the current Ebola epidemic raging in West Africa that continues to expand geographically and grow exponentially in spite of the strong efforts by the international community. There are no drugs or vaccines available for this infection, although some vaccines or drugs are being accelerated in clinical trials. The limitations of current anti-Ebola drug and vaccine development approaches are well known. Given the rapid mutation rate observed for the current Ebola virus, vaccines, antibodies, siRNA, and antisense RNA drugs based on previous strains of Ebola virus can be generally thought to have limited applicability, even if they succeed initially. In contrast, the nanoviricides® approach of developing a drug that imitates the sites to which the virus binds, no matter how much it mutates, is promising. In addition, if a successful drug candidate results, we believe that our production capacity would be responsive to the current requirements for the containment of the Ebola epidemic in West Africa.
In June 2013, with an improved cash position, we were able to re-engage our anti-Dengue drug development program. This drug candidate has received an orphan drug designation with the US FDA in August 2013, and with the European Medicines Agency (EMA) in November 2013. The orphan drug designation carries substantial benefits with it that could result in significant financial benefits to NanoViricides if the drug passes through the regulatory processes successfully. Additionally, in the USA, we can also expect to be issued a Priority Review Voucher (PRV). The PRV may be applied to fast track the development of another one of our drugs or can be sold to another pharmaceutical company for the same purpose.
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. 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 also developing DengueCide, a broad-spectrum drug that 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. In September, 2013, 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 is also developing a drug against Oral “Cold Sores” and Genital Herpes.
“We now have a c-GMP compliant manufacturing facility for the clinical scale production of any of our drug candidates,” said Anil R. Diwan, PhD, President and Chairman of the Company, adding, “As this facility becomes productive, we will gain the ability to move our drug candidates into the human clinical trials in a rapid succession. ”
“With almost $50M in hand, we are in an excellent financial position,” 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.”
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.