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NanoViricides, Inc. Has Filed its Annual Report, Company Advancing Rapidly Towards First IND
SHELTON, Conn., Aug. 26, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), reports that it has filed its annual report (Form 10-K) for the financial year ending June 30, 2019, with the Securities and Exchange Commission (SEC) on Friday, August 23, 2019. The report can be accessed at the SEC website(https://www.sec.gov/Archives/edgar/data/1379006/000114420419041547/tv525970_10k.htm).
The Company reported that, as of June 30, 2019, it had cash and cash equivalent current assets balance of approximately $2.8 Million. In addition, the Company reported $10.2 Million in Property and Equipment (P&E) assets. The strong P&E assets comprise the Company's fully owned cGMP-capable manufacturing and R&D facility in Shelton, CT. The Company has no debt. In comparison, as of June 30, 2018, we had cash and cash equivalent balance of approximately $7.08 Million, P&E assets of approximately $10.8 Million, and no debt. The reduction in current cash has resulted from continuing operating expenditures. With the strong asset position and no debt, the Company continues to have a strong fiscal position as it is advancing its drugs towards human clinical trials.
The Company has performed production of its first drug product for IND-enabling Safety/Toxicology studies in multi-kilogram scale at our Shelton facility, resulting in cost savings for our first drug program estimated at a few million dollars. The Company intends to perform the Phase I and Phase II cGMP drug production for anticipated human clinical trials at this facility. Having our own cGMP-capable manufacturing facility is expected to continue to enable several millions of dollars in cost savings for our drug development pipeline and programs.
Research and development expenses for the year ended June 30, 2019 were about $5.92 Million, approximately similar to the prior year ending June 30, 2018, adjusted to about $5.91 Million. General and administrative expenses (G&A) were at about $2.7 Million, compared to $3.4 Million in the prior year. The decrease in G&A is primarily due to reduction in executive payroll, legal, professional, and consulting costs.
For the year ended June 30, 2019, the Company had a net loss of about $8.42 Million, or a basic loss per share of $0.12 compared to a net loss of about $8.56 Million, or a basic loss per share of $0.13 for the year ended June 30, 2018.
During the financial year, the Company has taken steps to strengthen its management team and its board to substantially expand pharmaceutical industry expertise. Mr. James Sapirstein joined the Board and its Committees as an independent director on November 1, 2018, and the Company regained full compliance with NYSE requirements. Mr. Sapirstein is a well-known Pharma Industry veteran, with 35+ years of Pharma experience, having been part of almost two dozen product launches, and serving on several board positions. Dr. Mark Day was appointed as an independent director to the Company's Board of Directors and its Committees, effective June 6, 2019. Dr. Day has over 16 years of experience in the pharmaceutical industry with expertise in opportunity due diligence and in-licensing at big pharma as well as out-licensing from biotech. Subsequent to the reporting period, Dr. Mukund Kulkarni resigned from the Board for personal reasons, as of July 31, 2019. With these re-structuring events, the Company now has significant pharmaceutical industry expertise in its Board members and consultants.
The Company has continued its focus on taking its first drug candidate into human clinical trials at the earliest possible date. The Company declared a clinical candidate for the treatment of Shingles rash, namely, NV-HHV-101, and began IND-enabling Safety/Toxicology and other required studies in December, 2018. Shingles is caused by the reactivation of the chickenpox virus, i.e. VZV, in adults. The first non-GLP portion of these studies was successfully completed around February, 2019. The drug was well tolerated even at the highest dosages applied. There were no adverse observations. Thereupon NV-HHV-101 progressed to the formal GLP portion of the Safety/Toxicology studies which began around May, 2019. The Company and TheraCour Pharma, Inc. have agreed upon the general terms of a license agreement for VZV, and have exchanged drafts of a definitive licensing agreement to be perfected.
The Company reported that NV-HHV-101 has been found to be safe and well tolerated at all dosage levels in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment, on August 5, 2019, subsequent to the reporting period. The in-life stage of the first part of the GLP Safety/Toxicology studies is complete. The Company is waiting on the full histology studies to assess the effects on all primary organs. Both the non-GLP and GLP Safety/Toxicology studies are conducted by BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies.
Thus, our first drug candidate, NV-HHV-101, is on track moving towards human clinical trials. Additional required studies for filing an IND are also in progress.
The Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication, assuming that these IND-enabling studies are successful. To this end, the Company requested a pre-IND meeting with the US FDA and the Agency has generally agreed in its pre-IND response in May 2019 that the plan of drug development presented by the Company to the FDA is generally adequate at this time. The Company will need additional funds to file the IND application and perform human clinical trials.
The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes.
The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
The Company's drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our intellectual property. The Company has a worldwide exclusive license to this technology for several drugs with specific targeting mechanisms for the treatment of a number of human viral diseases including HSV-1 and HSV-2. Additionally, the Company and TheraCour have signed a Memorandum of Understanding governing the general terms of a license for VZV drug development in February 2019. A definitive agreement is currently being negotiated between the parties.
The Company intends to perform the regulatory filings and own all the regulatory licenses for the drug candidates it is currently developing. The Company will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials.
The Company has achieved several important milestones in this year. In brief, these include the declaration of a final clinical candidate for its lead drug indication, achieving successful cGMP-like production of the drug as required for the Safety/Toxicology ("Tox Package") studies, initiation and completion of the Tox Package studies, and a Pre-IND meeting with the FDA. In addition, the Company has initiated cGMP clinical drug manufacture for human clinical trials of NV-HHV-101. We have advanced the drug candidate as rapidly as possible, given resource constraints and our dependence on external parties for the performance and completion of various studies.
The Company believes it is on course to file its first IND and initiate human clinical trials in the ensuing year, towards establishing human proof-of-concept for the nanoviricides platform. The Company intends to raise the additional funds needed for these objectives through equity or debt financings. Our objectives for the ensuing year include: Finalizing human clinical trials designs; Engaging a Clinical CRO; Completion of the IND-enabling studies; Preparation of various required reports and Filing of an IND; cGMP Production of required clinical quantity of the drug; Submission of an IND-application to the US FDA, or an appropriate international regulatory agency; and Initiation and Performance of Phase I human clinical trials, to determine safety and tolerability of NV-HHV-101 in human subjects.
Assuming successful completion of Phase I human clinical trials, we intend to initiate Phase II human clinical trials to determine effectiveness of NV-HHV-101 in controlling shingles rash and to study the effectiveness of NV-HHV-101 regarding shingles pain.
In general, as a pharmaceutical company achieves these milestones, its risk-profile with investors improves as reflected in the market capitalization. Management believes that as the Company achieves these milestones, it could significantly improve the Company's ability to raise funds in the public markets. However, there can be no assurance that the Company will achieve any of these milestones or that such achievements will reflect favorably in the share price and market cap metrics. Management is actively exploring additional required funding for its planned objectives through debt or equity financing. There is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company to fund continuing operations.
About the Company
NanoViricides, Inc. is a global leader in the application of nanomedicine technologies to the complex issues of treatments for viral diseases. 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.
Our anti-viral therapeutics, that we refer to as "nanoviricides®" are designed to mimic and look to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus- binding portion of the nanoviricide is engineered appropriately.
The Company's most advanced pre-clinical drug candidate is our anti-VZV nanoviricide for the topical treatment of shingles, being developed as a skin cream. In cell culture studies, it was as much as five times more effective than acyclovir, the current standard of care. Our anti-VZV drug candidates have also shown strong effectiveness in studies involving VZV infection of human skin patch organ culture ex vivo model. These studies were conducted by Professor Jennifer Moffat at the SUNY Upstate Medical Center in Syracuse, NY, an internationally recognized expert on varicella-zoster virus (VZV) infection, pathogenesis, and anti-viral agent discovery. Some of the early work was presented at the 31st International Conference on Antiviral Research held June 11 - June 15, 2018 in Porto, Portugal.
Our Shelton, CT facility contains a multi-kilogram scale c-GMP-capable manufacturing facility that is capable of producing any of our nanoviricides, whether oral, skin cream or injectables. We are manufacturing the current clinical candidate at this facility.
We believe that our facility makes NanoViricides one of the very few development stage pharma companies that possess fully integrated drug development capability from design/discovery, synthesis, characterization, scaling up for clinical drug development, and cGMP-capable manufacturing to support initial market entry, when licensed, for any of our nanoviricides drug candidates.
The Company's primary focus is bringing the topical treatment for shingles into human clinical trials, which we believe is our most advanced drug indication. Shingles is caused by reactivation of VZV (Varicella-Zoster Virus), which causes chickenpox in children. We anticipate that several additional indications in the HerpeCide™ program, including skin creams for the treatment of "genital ulcers" (HSV- 2), and for the treatment of "cold sores" (HSV-1") would follow the shingles candidate into clinical development. In addition, the Company has drug candidates in development against severe influenzas (including bird flu), HIV, Dengue, Ebola/Marburg and other viruses at different preclinical stages. The Company will require additional funding to pursue these candidates. According to a 2014 market report prepared by Jain PharmaBiotech ("Jain"), entitled "Antiviral Therapeutics, Technologies, Markets & Companies," the overall market size for our potential drugs is estimated to be between $40~65 Billion by 2023. This broad pipeline is enabled by our unique post-immunotherapeutic "bind-encapsulate-destroy" technology platform.
NanoViricides, Inc. (www.nanoviricides.com) 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, shingles and chickenpox, 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 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. EMA refers to the European Union's office of European Medicines Agency.)
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SOURCE NanoViricides, Inc.