NanoViricides filed Quarterly Report for period ending December 31, 2019

Sufficient Cash, HerpeCide(TM) Drug Candidate IND Application Development in Progress

SHELTON, CT / ACCESSWIRE, 2020年2月26日 - (亞太商訊) - NanoViricides, Inc. (NYSE American: NNVC), a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, has filed its quarterly report for its second quarter of financial year 2020 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 February 14, 2020. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465920021930/tm205411-1_10q.htm.

The Company reported that it had approximately $1.0 Million (M) of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $1.4M excluding a recent mortgage (described below), as of December 31, 2019, the end of the reporting period. The net cash used in operating activities during the six months period was approximately $2.56M. The Company's expenditures were in line with budget estimates. Shareholder equity stood at approximately $7.72M for the quarter (unaudited figures), primarily due to the asset value of its cGMP-capable manufacturing facility, R&D labs, and equipment, that it owns fully except for a $2 Million secured debt provision. The Company had no revenues. The Company has no long term debt.

The Company drew down $1.1M from a $2M non-convertible loan commitment secured by a mortgage on the Company's facility provided by the Company's founder and President, Anil R. Diwan, PhD. The mortgage is payable in full on March 31, 2021, with no payments due until then. Interest is payable only on amounts drawn by the Company.

In subsequent events, the Company has previously reported that it has raised approximately $8.625M in gross proceeds in an underwritten public offering, pursuant to an effective Form S-1 registration statement, comprising the sale of 2.5 million shares plus 375,000 shares of an underwriters over-allotment option at a price of $3 per share, with no warrants issued in the transaction. Aegis Capital Corp. acted as sole bookrunner for the offering. The net proceeds to the Company after underwriter's commission and agreed upon customary fees and expenses were approximately $7.78 million, before deducting the Company's legal and accounting expenses related to the Offering.

With these cash inflows, the Company believes it has sufficient funding for its planned expenditures for the ensuing year, based on estimated budgets including costs of certain clinical trials.

In subsequent events, the Company previously reported that it is working on developing a therapeutic drug for the treatment of the novel coronavirus 2019-nCoV, aka COVID-19. In 2014, the Company had engaged in drug discovery efforts against MERS coronavirus. The Company has reported that it has already found broad-spectrum virus-binding ligands that are expected to attack the virus at the same points that the virus uses to bind to its cognate cellular receptor, namely ACE-2 (angiotensin converting enzyme type 2), using molecular modeling based on known SARS-CoV and ACE2 interactions. COVID-19 shares significant similarity with, and uses the same cellular receptor as, SARS-CoV. The Company intends to perform initial testing of these drug candidates for safety and effectiveness in cell culture studies in its own BSL-2 virology laboratory at its Shelton campus, using low-threat coronavirus strains that have been normally circulating in human population.

The Company is working on developing necessary collaborations to take the program further should an effective drug candidate be identified. However, there can be no assurance that the Company will be successful in entering into such collaborations or that such collaborations will lead to an effective drug candidate. The Company does not currently have a license for the coronavirus field from TheraCour Pharma, Inc. ("TheraCour"), the licensor of the Company's pharmaceutical candidates and a significant shareholder. Customarily, the Company enters into licensing agreements with TheraCour after a potential drug candidate is demonstrated to be likely effective against the virus. TheraCour has not previously denied any licenses sought by the Company.

The Company has experience developing broad-spectrum cellular receptor mimetics as virus-binding ligands for creating nanoviricide drugs. The Company has demonstrated this capability notably in its HerpeCide(TM) program, wherein nanoviricides based on the same antiviral ligand were found to be effective against at least three different kinds of herpesviruses, namely herpes simplex-1 (HSV-1), herpes simplex-2 (HSV-2), and, surprisingly, the non-simplex varicella zoster virus (VZV).

It is well recognized that development of vaccines takes a long time, and that vaccines can often be ineffective against viruses due to viral mutations that lead to emergence of resistant strains. It is also well recognized and well documented that monoclonal antibodies as antiviral drugs are very difficult to develop and often lead to emergence of resistant viral strains due to viral mutations.

In contrast, the Company believes that, its nanoviricide biomimetic technology platform has the potential to develop broad-spectrum antiviral drugs that viruses may not be able to escape due to mutations.

The Company continues to advance its first drug candidate, namely NV-HHV-101 skin cream, for the treatment of shingles rash as its first indication, towards human clinical trials. All of the planned IND-enabling Safety/Toxicology studies as well as other required non-clinical studies have been completed, and draft reports of various studies are being circulated between collaborating parties, as of the filing date. The Company anticipates receiving final cGLP reports for inclusion in our IND filing once the quality assurance processes are completed.

The Company has undertaken cGMP manufacture of the drug product, namely, NV-HHV-101 skin cream, indicated for the topical treatment of shingles rash, for supplying anticipated Phase I human clinical trials at its own facility. The Company has industry-leading internal expertise in the cGMP manufacture of complex nanomedicines drugs, right from simple starting materials to formulated drug products.

In a human skin patch organ culture model ex vivo, the Company has previously demonstrated the effectiveness and safety of topical NV-HHV-101 against VZV, the cause of shingles and chickenpox. These studies were conducted by Professor Jennifer Moffat at the Upstate Medical Center, SUNY Syracuse, NY. Professor Moffat has developed this model for pre-clinical evaluation of therapeutics against VZV, and is a well known expert in the field.
  • 新聞關鍵字: COVID-19macrainMERSnsaline

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