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- Rescinded resignation of Dr.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.