NanoViricides, Inc. — Form 10-Q
Reporting period: Fiscal quarter and six months ended December 31, 2022; filed February 14, 2023. The company is a pre-revenue antiviral drug developer whose lead program is NV-CoV-2. Common stock trades on NYSE American as NNVC.
Financial results and position
| Metric | Three months ended Dec. 31, 2022 | Six months ended Dec. 31, 2022 | Comparable 2021 period |
|---|---|---|---|
| Revenue | $0 | $0 | $0 |
| Research and development | $1.17 million | $2.28 million | $1.26 million / $3.36 million |
| General and administrative | $0.66 million | $1.17 million | $0.66 million / $1.17 million |
| Net loss | $1.75 million | $3.32 million | $1.92 million / $4.53 million |
| Loss per share, basic and diluted | $0.15 | $0.29 | $0.17 / $0.39 |
| Operating cash used | — | $2.43 million | $2.84 million for six months |
At December 31, cash and cash equivalents were $11.45 million, total current assets $11.55 million, current liabilities $0.46 million, and total assets $20.33 million. Stockholders’ equity was $19.87 million. The company reported no loan payable at quarter-end; the $94,788 insurance-financing loan outstanding at June 30 was repaid. Revenue-based margins are not meaningful because the company has no revenue.
Changes versus prior period
- Six-month operating expenses fell 24% to $3.46 million, largely reflecting lower outside-lab spending and the absence of the prior-year $935,088 preferred-stock license milestone expense paid to related party TheraCour.
- Six-month net loss narrowed by $1.22 million, while operating cash use declined by about $0.41 million.
- Cash fell $2.62 million from June 30, 2022. No shares were sold under the ATM offering during the six months; common shares outstanding increased modestly, primarily through equity compensation and service issuances.
- Interest income rose to $141,516 for six months from $3,127, reflecting higher interest rates.
Business outlook, risks and notable items
- Management said existing cash should fund planned operations for at least 12 months from the filing date and believes funds are sufficient for initial NV-CoV-2 human trials. Later-stage trials and longer-term operations will require additional capital, a partnership, or other financing; no financing is assured.
- The company was preparing US and international clinical-trial submissions for NV-CoV-2. It reported progress on manufacturing and application materials, but the US IND had not yet been submitted; a CRO was still being engaged. An overseas application and most related agreements were described as completed, with collaboration details pending formal steps.
- Management expects clinical-trial costs to increase and timelines and budgets may change. The company has no commercialized products and anticipates continuing losses; it has an accumulated deficit of approximately $125.8 million.
- NV-CoV-2 efficacy and safety statements in the filing are management’s descriptions of preclinical findings, not evidence of established human safety or effectiveness. Drug development, regulatory approval, manufacturing, funding and partnering are material uncertainties.
- The company depends on exclusive technology licenses and development services from TheraCour, an entity controlled by CEO and Chairman Anil Diwan. Related-party R&D charges were $1.25 million for the six months; related-party accounts payable, net of a $465,000 advance, were $373,424 at December 31. Commercialization royalties to TheraCour are 15% of net sales.
- Disclosure controls were deemed ineffective as of December 31 because a previously identified material weakness in period-end review and staffing/resources remained unremediated. Management described a remediation committee and review process.
- No material legal proceedings were reported. The filing states no off-balance-sheet arrangements and no defaults upon senior securities.
Key facts for investors to verify
- Whether and when the company submits an IND or obtains authorization to begin human trials, and the status of any overseas trial application or collaboration.
- Actual trial readiness, CRO/vendor agreements, clinical supply completion, regulatory feedback and resulting trial costs.
- Cash burn and runway as clinical development advances; available ATM capacity and potential dilution from future financing.
- Progress in remediating the material weakness and improving financial-reporting controls.
- Terms, ongoing charges and governance implications of the TheraCour relationship, including the related-party balance and 15% royalty obligation.