SHELTON, CONNECTICUT -- Monday, May 20, 2019 -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the "Company"), has filed its quarterly report for its third quarter of financial year 2019 in a timely manner with the Securities and Exchange Commission. This press release should be read in conjunction with the Form 10-Q filed on May 15th, 2019. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000114420419026612/tv519975_10-q.htm.
The Company reported that it had approximately $4.63Million (M) of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $1.08M, as of March 31, 2019, the end of the reporting period.
The net cash used in operating activities during the last nine months (last three quarters) was approximately $5.13M, compared to approximately $4.26M in the nine months ending March 31, 2018. The Company's expenditures were in line with budget estimates. Shareholder equity stood at approximately $12.72M for the quarter (unaudited figures). The Company had no revenues.
The Company has no long term debt.
The Company raised $2.5M on February 27, 2019 in a registered direct offering (the "Offering") of 6,944,446 shares of Common Stock ("Shares") at the purchase price of $0.36 ("Purchase Price") per share. In a concurrent private placement, the Purchasers received warrants (the "Warrants") to purchase up to 6,944,446 shares of Common Stock. The Warrants have an exercise price of $0.61 per share, shall be exercisable on the six month anniversary of issuance and will expire five (5) years thereafter. The Warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise. The net proceeds from this offering were approximately $2.35M after deducting placement agent commission and agent legal fees. Chardan Capital Markets, LLC acted as a placement agent for this offering.
The Company is pleased to note that it has been executing on all milestones towards the IND filing for its first clinical candidate along a reasonable projected timeline, and is doing so with highly conservative expenditures.
The Company is pleased to note that it has taken its first lead drug candidate, namely NV-HHV-101 through IND-enabling non-GLP Safety/Toxicology ("Tox Package") studies successfully, enabling the beginning of the GLP Tox Package studies. The Company has filed a pre-IND application with the US FDA for questions regarding the clinical trials design.
Importantly, the Company has completed manufacture of the drug substance of NV-HHV-101 on kilogram-scale and of the fully formulated drug product (skin cream) on a multi-kg scale. These manufacturing operations were performed in its own cGMP-capable facilities under cGMP-compliant conditions. Thus the Company now has demonstrated expertise in the cGMP manufacture of complex nanomedicines drugs, right from simple starting materials to formulated drug products.
The Company believes that enabling cGMP manufacture at large scale de-risks all of its drug programs to a substantial degree in terms of manufacturing risk. cGMP Manufacture of nanomedicines is known to be complex. Additionally, the Company expects to reduce the costs of its drug programs substantially because of being able to manufacture the drug products for human clinical trials.
The Company has repeatedly demonstrated in a human skin organ culture model of VZV infection that NV-HHV-101 and several related candidates were highly effective against VZV infection in this ex vivo model of the VZV viral infection. These studies are being performed by Professor Jennifer Moffat at the Upstate Medical Center, SUNY, Syracuse, NY. Dr. Moffat is a leading researcher in this field and has developed this model based on infection of human skin.
It is anticipated that the high effectiveness observed in this model should be predictive of effectiveness in human clinical trials.
NanoViricides is pioneering a unique platform for developing anti-viral drugs based on the "bind-encapsulate-destroy" principles. Viruses would not be able to escape a properly designed nanoviricide® drug by mutations because in doing so they would lose the ability to bind their cognate cellular receptor(s) and thus fail to infect productively, becoming incompetent.
NanoViricides is a unique pre-clinical pharma company in that it fully owns its own lab and cGMP-capable flexible custom manufacturing facility where any of our drug candidates can be produced in multi-kilogram quantities to support corresponding IND-enabling tox package studies as well as initial human clinical trials. This enables rapid translation of our drug candidates to the clinic, saving years of manufacturing translation and set-up activities, as well as saving several millions of dollars of external costs, while ensuring requisite quality assurance, as compared to using a contract manufacturing organization ("CMO") for our complex nanomedicine drugs.
The Company is currently working on its broad-spectrum drug candidates in the HerpeCide™ program against several indications. These include three dermal topical treatment indications, namely, skin creams for HSV-1 "cold sores", HSV-2 "genital ulcers", and shingles rash caused by VZV. Further, the Company is also working on developing eye drops for treatment of Herpes Keratitis (an infection of the external eye), and intra-vitreal injection for the treatment of vARN, in this program. The Company has also previously demonstrated excellent results in its FluCide™ program and in its HIVCide™ program, among others. Thus the Company has a rich and expanding pipeline of highly effective and safe drug candidates against a number of viral diseases. In addition, the Company's technology has substantial capabilities and applications, and the potential to attack as-yet-unsolved problems caused by viral infection, and thus lead to a great health benefit to individuals and societies. The Company has a bright future with its expanding pipeline, as we further the research programs driving towards cures beyond our current objectives of effective treatments.
The market size for HerpeCide programs is in several tens of billions of dollars because neither cures nor very effective treatments are available. Approved treatments have limited effectiveness, demonstrating a significant unmet medical need.
There is a significant unmet medical need for the topical treatment of shingles rash. An effective therapy for shingles has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy for shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine and the impact of the existing Zostavax® vaccine. Of note, the Shingrix vaccine has been found to cause significant, debilitating, side effects in as many as 15%-20% of the persons receiving it. Given that shingles is not a life-threatening disease (except under certain conditions), the uptake of such a vaccine with high incidence of adverse effects may be limited. Additionally, Shingrix is not yet widely available.
The Company develops its class of drugs, that we call nanoviricides®, using a platform technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour Pharma, Inc. NanoViricides holds licenses for developing drugs against several different viruses from TheraCour, including HSV-1 and HSV-2. In addition, the Company and TheraCour have signed a Memorandum of Understanding of the terms of a license for VZV (shingles, chicken pox virus), and the remaining human herpesviruses from TheraCour. For this purpose, the Company has conducted a valuation for the shingles and PHN indications. TheraCour is owned substantially by the Company's President and Executive Chairman of the Board, Anil R. Diwan, Ph.D. As of this writing, a draft of the ensuing license agreement is being prepared by the Company's attorneys. The draft is expected to be provided to TheraCour's attorney for further deliberations.
Thus we have made significant and substantial progress in the reporting quarter towards the goal of filing our first IND application, and we continue to build on this progress.
The Company has previously stated that it will be required to raise additional capital in the near future to fund our drug candidates as they advance towards IND stage and into human clinical trials, as is the case with most if not all non-revenue innovative pharmaceutical companies.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.