Climate Change Data

NanoViricides, Inc.

Climate Impact & Sustainability Data (2012-07-01 to 2012-06-30, 2018, 2019)

Reporting Period: 2012-07-01 to 2012-06-30

Environmental Metrics

Social Achievements

  • Limited expenditures on socially conscious projects such as "Neglected Tropical Diseases" (NTDs), and "Bio-defense" projects to the extent that participatory funding from third parties is available.

Governance Achievements

  • Appointed Mr. Stanley Glick, CPA, as an independent Director of the Company and the Chairman of its Audit Committee.

Climate Goals & Targets

Environmental Challenges

  • Weak financial markets resulted in substantial limitations on capital-raising efforts.
  • Scaled down programs, particularly the cGMP manufacturing facility program, to meet financial challenges.
Mitigation Strategies
  • Scaled down programs to meet financial challenges.
  • Aggressively seeking cash-preserving means of financing for the new lab and cGMP capability (SBA loans, other loans, alternate financing vehicles, equity-based financing).

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Period: 2018

Environmental Metrics

Climate Goals & Targets

Short-term Goals:
  • Clinical candidate declaration for shingles and chickenpox
  • Production of sufficient material for toxicology studies
  • Complete licensing agreement with TheraCour Pharma
  • File an IND application
  • Begin Phase I human clinical studies

Environmental Challenges

  • Fiscal constraints leading to R&D staffing reduction (25% in the last few years), lengthening the timeline to begin human clinical trials.
  • Non-compliance with NYSE’s continued listing requirements due to insufficient members on the audit committee.
  • Limited experience in drug development and conducting clinical trials, necessitating outsourcing.
  • Limited manufacturing experience and lack of sales and marketing personnel.
  • Dependence on TheraCour Pharma, Inc. for core technology and manufacturing.
  • Difficulty in attracting and retaining highly skilled personnel.
  • Conflicts of interest among officers, directors, and stockholders.
Mitigation Strategies
  • Focused efforts on the HerpeCide program, prioritizing the shingles indication.
  • Rescinded resignation of Dr. Kulkarni from the audit committee and actively interviewing candidates for additional independent directors.
  • Outsourcing clinical trials to third parties.
  • Owning a cGMP-capable manufacturing facility to potentially enable initial market entry.
  • Negotiating with TheraCour Pharma, Inc. for additional licenses.
  • Implementing a continuous training program for employees.
  • Establishing a Search Committee to find additional independent directors.
  • Maintaining a majority independent Board of Directors, a fully independent Compensation Committee, and a fully independent Audit Committee.

Supply Chain Management

Climate-Related Risks & Opportunities

Awards & Recognition

  • Most Innovative Business Leaders of 2016 by AI Global Media

Reporting Period: 2019

Environmental Metrics

Climate Goals & Targets

Short-term Goals:
  • Finalize human clinical trials designs for Phase I and Phase II trials for NV-HHV-101 for topical treatment of shingles rash.
  • Engage a contract Clinical Research Organization for conducting the human clinical trials.
  • Complete the IND-enabling studies, and prepare appropriate reports.
  • Complete manufacture of cGMP-compliant drug substance and drug products in quantities sufficient for anticipated human clinical trials as designed.
  • Submit an IND-application to the US FDA, or an appropriate international regulatory agency.
  • Initiate and conduct Phase I human clinical trials, to determine safety and tolerability of NV-HHV-101 in human subjects.
  • If possible, 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.

Environmental Challenges

  • Fiscal constraints leading to a 40% reduction in R&D staffing at affiliates, lengthening the timeline to begin human clinical trials.
Mitigation Strategies
  • Focused efforts primarily on the HerpeCide program, prioritizing the shingles indication to maximize return on investment and shareholder value.

Supply Chain Management

Climate-Related Risks & Opportunities