NanoViricides(NNVC) - 2021 Q3 - Quarterly Report

PART I FINANCIAL INFORMATION Financial Statements The unaudited financial statements for the period ended March 31, 2021, show a significant increase in cash and total assets compared to June 30, 2020, primarily due to equity financing activities, with the company continuing to operate at a net loss and an accumulated deficit of approximately $112.3 million, while operating expenses, particularly Research and Development, have increased year-over-year, reflecting intensified drug development efforts Balance Sheets As of March 31, 2021, the company's total assets were $32.8 million, a significant increase from $23.9 million at June 30, 2020, driven by a rise in cash and cash equivalents from $13.7 million to $22.9 million, while total liabilities decreased from $2.2 million to $0.9 million, primarily due to mortgage note repayment, consequently increasing total stockholders' equity from $21.8 million to $31.9 million Balance Sheet Summary (Unaudited) | Balance Sheet Items | March 31, 2021 ($) | June 30, 2020 ($) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | 22,899,518 | 13,708,594 | | Total current assets | 23,231,069 | 13,985,657 | | Property and equipment, net | 9,174,355 | 9,544,431 | | Total assets | 32,761,125 | 23,914,339 | | Liabilities & Equity | | | | Total current liabilities | 871,344 | 2,156,377 | | Total stockholders' equity | 31,889,781 | 21,757,962 | | Total liabilities and stockholders' equity | 32,761,125 | 23,914,339 | Statements of Operations For the nine months ended March 31, 2021, the company reported a net loss of $6.7 million, a significant improvement from the $11.6 million net loss in the same period of 2020, primarily due to the absence of a large non-cash expense related to the change in fair value of derivative liability present in the prior year, while operating expenses increased from $6.2 million to $6.7 million, driven by higher research and development costs Statements of Operations Summary (Unaudited) | Metric | Nine Months Ended Mar 31, 2021 ($) | Nine Months Ended Mar 31, 2020 ($) | | :--- | :--- | :--- | | Research and development | 4,530,448 | 3,628,622 | | General and administrative | 2,139,392 | 2,536,050 | | Loss from operations | (6,669,840) | (6,164,672) | | Change in fair value of derivative liability | - | (5,845,313) | | Net loss | (6,749,317) | (11,571,963) | | Net loss per common share | (0.63) | (2.45) | Statements of Changes in Stockholders' Equity Stockholders' equity increased from $21.8 million at June 30, 2020, to $31.9 million at March 31, 2021, primarily driven by net proceeds of approximately $16.6 million from common stock issuance through equity financing, partially offset by a net loss of $6.7 million for the nine-month period - Net proceeds from the issuance of common stock in connection with equity financing totaled approximately $16.6 million for the nine months ended March 31, 2021[13] - The accumulated deficit grew from $105.6 million at June 30, 2020, to $112.3 million at March 31, 2021, due to continued net losses[13] Statements of Cash Flows For the nine months ended March 31, 2021, net cash used in operating activities was approximately $6.0 million, while net cash provided by financing activities was $15.3 million, primarily from common stock issuance, resulting in a net increase in cash and cash equivalents of $9.2 million, bringing the ending balance to $22.9 million Cash Flow Summary (Unaudited) | Cash Flow Activity | Nine Months Ended Mar 31, 2021 ($) | Nine Months Ended Mar 31, 2020 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (5,986,138) | (4,957,235) | | Net cash used in investing activities | (154,122) | (4,139) | | Net cash provided by financing activities | 15,331,184 | 8,511,697 | | Net change in cash and cash equivalents | 9,190,924 | 3,550,323 | | Cash and cash equivalents at end of period | 22,899,518 | 6,105,530 | Notes to the Financial Statements The notes detail the company's business, liquidity status, accounting policies, and specific financial items, highlighting its focus on the COVID-19 drug program, reliance on licensed technology from TheraCour Pharma, Inc., and its financial condition as a development-stage company with no revenue, having raised significant capital through equity offerings to ensure sufficient funds for operations for at least the next twelve months, with additional details on related-party transactions, equity issuances, and employment agreements - The company is a nano-biopharmaceutical R&D firm focused on developing drugs for viral infections, with its lead program currently targeting COVID-19[20][21] - The company has an accumulated deficit of approximately $112.3 million as of March 31, 2021, and has not yet generated any revenue; management believes existing cash of $22.9 million is sufficient to fund operations for at least the next twelve months[27][35] - The company relies on exclusive licenses from TheraCour Pharma, Inc., a related party, for its core technology; a Memorandum of Understanding for a license in the field of coronaviruses was executed in June 2020 and extended to June 2021[23][24][70] - In July 2020 and March 2021, the company raised net proceeds of approximately $10.4 million and $6.1 million, respectively, through common stock offerings[29][31] Management's Discussion and Analysis of Financial Condition and Results of Operations Management's discussion focuses on the company's status as a development-stage biopharmaceutical firm with no revenue, highlighting its strategic pivot to prioritize the COVID-19 drug development program, detailing the progress of its lead candidates, NV-CoV-2 and NV-CoV-2-R, including promising pre-clinical safety and efficacy data, while the HerpeCide™ program, particularly NV-HHV-101 for shingles, remains a key asset, with development to resume after the COVID-19 program's clinical trials begin; the company has successfully raised capital, securing approximately $22.9 million in cash, deemed sufficient for operations for the next year, including initial clinical trials, and the analysis of operations shows an increased R&D spend and a decreased net loss compared to the prior year, primarily due to non-recurring derivative liability charges in 2020 Business Overview and Strategy NanoViricides is a development-stage company focused on creating anti-viral drugs using its proprietary nanomedicine platform technology, licensed from TheraCour Pharma, Inc., with a strategy to develop drugs that directly attack virus particles using a "bind-encapsulate-destroy" mechanism designed to be effective against viral mutations, and a current primary focus on advancing its COVID-19 drug candidates into human clinical trials, followed by its HerpeCide™ program for shingles - The company is a development-stage entity with no customers or revenue to date, focusing on pre-clinical drug development[77] - The core technology is based on an exclusive license from TheraCour Pharma, Inc., a related party controlled by the company's CEO, Dr. Anil Diwan[78] - The nanoviricide® platform technology is designed to create biomimetic drugs that directly attack multiple points on a virus particle, making it difficult for viruses to develop resistance through mutation[92][93] - The company operates its own cGMP-compliant manufacturing facility, enabling production of drugs for clinical trials, which is a significant strategic advantage[81] COVID-19 Drug Development Program The company has prioritized its COVID-19 program, developing two broad-spectrum, pan-coronavirus drug candidates: NV-CoV-2 and NV-CoV-2-R (which encapsulates remdesivir), with pre-clinical studies showing both candidates to be well-tolerated in safety pharmacology studies and highly effective in animal models, outperforming remdesivir in extending survival, and the company has completed required safety studies, is preparing a pre-IND application for the FDA, and has initiated cGMP-compliant manufacturing of the drug substance for clinical trials at its own facility - The lead drug candidates are NV-CoV-2 and NV-CoV-2-R; NV-CoV-2-R encapsulates remdesivir and is designed to attack both extracellular virus and intracellular viral replication[88][89] - Safety pharmacology studies in rats and non-human primates found NV-CoV-2 to be well-tolerated, with no adverse effects on respiratory or cardiovascular functions at tested doses[102][108][109] - In a lethal coronavirus infection animal model, NV-CoV-2 and NV-CoV-2-R significantly extended survival to 14 and 16 days, respectively, compared to 7.5 days for remdesivir[112] - The company is preparing a pre-IND application for submission to the US FDA and is manufacturing the drug for clinical trials in its own cGMP-capable facility[91][129] HerpeCide™ Program and Other Pipeline The HerpeCide™ program is the company's other major focus, with the lead candidate being NV-HHV-101, a topical skin cream for treating shingles rash (VZV), which has shown strong effectiveness in human skin models, outperforming acyclovir, and the company has completed IND-enabling studies for NV-HHV-101 and plans to file an IND after its COVID-19 drug candidate enters clinical trials, while the HerpeCide pipeline also includes candidates for HSV-1 (cold sores) and HSV-2 (genital ulcers), and other programs like FluCide™ and HIVCide™ are at a lower priority due to resource constraints - The lead candidate, NV-HHV-101, is a skin cream for shingles that has completed IND-enabling studies and has shown strong effectiveness, being up to five times more effective than acyclovir in cell culture studies[162][80] - The company has successfully scaled up cGMP-like manufacturing of the NV-HHV-101 API and the final cream product at its own facility, saving significant time and cost[169] - The HerpeCide™ pipeline targets a multi-billion dollar market and includes treatments for VZV (shingles), HSV-1 (cold sores), HSV-2 (genital ulcers), herpes keratitis, and viral Acute Retinal Necrosis (v-ARN)[144][180][181] - Other programs, including FluCide™ and HIVCide™, have demonstrated high effectiveness in animal models but are currently at a lower development priority due to limited resources[225][228] Intellectual Property The company's intellectual property is founded on a worldwide, exclusive, perpetual license from TheraCour for its nanomedicine technology across a range of specified viruses, including Coronaviruses (via a recent MOU), Herpes viruses, Influenza, and HIV, covering patents, know-how, and trade secrets, with the core technology protected by over 61 issued patents globally, having nominal expiry dates ranging from 2027 to 2029, and the company plans to file additional patents for its specific drug candidates as they advance toward clinical trials - Holds a worldwide exclusive license from TheraCour for its technology to treat numerous viruses, including a recent MOU for human coronaviruses[248][249][250] - The license agreements include milestone payments upon achieving regulatory and clinical milestones, such as $1.5 million in cash upon completion of Phase I trials for the VZV drug[249] - The fundamental platform technology is covered by over 61 issued patents globally, with nominal expiry dates between 2027 and 2029[255] Results of Operations For the nine months ended March 31, 2021, the company reported a net loss of $6.7 million, compared to a net loss of $11.6 million for the same period in 2020, with the decrease in net loss primarily attributable to a non-cash charge of $5.8 million for the change in fair value of derivative liabilities in the prior year, which did not recur, while research and development expenses increased by $0.9 million due to intensified lab activities, and general and administrative expenses decreased by $0.4 million Operating Expenses Comparison (Nine Months Ended March 31) | Expense Category | 2021 ($) | 2020 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and Development | 4,530,448 | 3,628,622 | +901,826 | | General and Administrative | 2,139,392 | 2,536,050 | -396,658 | Net Loss Comparison (Nine Months Ended March 31) | Metric | 2021 ($) | 2020 ($) | | :--- | :--- | :--- | | Net Loss | $(6,749,317) | $(11,571,963) | | Net Loss per Share | $(0.63) | $(2.45) | - The significant decrease in net loss for the nine months ended March 31, 2021, was mainly due to the absence of a $5.8 million non-cash expense from the change in fair value of derivative liabilities that was recorded in the prior-year period[289][291] Liquidity and Capital Resources As of March 31, 2021, the company had cash and cash equivalents of $22.9 million and an accumulated deficit of $112.3 million, having raised approximately $6.1 million in net proceeds from an "At-the-Market" offering on March 2, 2021, and management believes existing cash resources are sufficient to fund planned operations and expenditures, including initial human clinical trials for its COVID-19 drug candidate, for at least the next twelve months, though additional capital will be required to fund long-term operations and further clinical trials - The company had cash and cash equivalents of $22,899,518 as of March 31, 2021[292] - On March 2, 2021, the company sold 814,242 shares of common stock in an "At-the-Market" offering, raising net proceeds of approximately $6.1 million[292] - Management believes existing resources are sufficient to fund operations for at least the next twelve months, but long-term plans will require additional capital[293][296] - The COVID-19 pandemic has not had a direct adverse financial impact but required a reorganization of priorities, shifting focus from the shingles program to the COVID-19 program[295] Quantitative and Qualitative Disclosures About Market Risk The company states that its primary market risk exposure is non-material interest rate risk associated with its short-term cash equivalent investments, having no foreign operations, no exposure to foreign currency fluctuations, and not using derivative financial instruments for speculative purposes - The company's primary market risk is interest rate risk on its cash equivalents, which is considered non-material[301] - The company has no foreign operations and therefore no exposure to foreign currency exchange rate risk[301] Controls and Procedures Management, including the CEO and CFO, concluded that as of March 31, 2021, the company's disclosure controls and procedures were not effective due to a previously disclosed and unremediated material weakness in internal control over financial reporting, and the company has established a financial reporting controls committee to oversee remediation efforts - As of March 31, 2021, the company's disclosure controls and procedures were concluded to be not effective[303] - The ineffectiveness is due to a material weakness in internal control over financial reporting that was previously identified and remains unremediated[303] - A remediation plan is in place, involving a financial reporting controls committee to provide oversight and ensure the reliability and accuracy of financial reporting[305] PART II OTHER INFORMATION Legal Proceedings The company reports that there are no pending legal proceedings against it, and to its knowledge, no action, suit, or proceeding has been threatened - As of the filing date, there are no legal proceedings against the company, and none are known to be threatened[309] Unregistered Sales of Equity Securities and Use of Proceeds During the nine months ended March 31, 2021, the company issued unregistered securities for compensation and services, including 2,501 shares of Series A preferred stock for employee compensation, warrants to purchase common stock for its Scientific Advisory Board, 18,677 shares of common stock for consulting services, 9,446 shares for Director services, and 3,572 shares for employee compensation, all issued in reliance on exemptions from registration under the Securities Act - For the nine months ended March 31, 2021, the company issued 2,501 shares of Series A preferred stock and 3,572 shares of common stock for employee compensation[310][314] - Warrants to purchase common stock were granted to the Scientific Advisory Board[311] - A total of 18,677 common shares were issued for consulting services and 9,446 common shares for Director services during the nine-month period[312][313] Defaults Upon Senior Securities The company reported no defaults upon senior securities - None[316] Mine Safety Disclosures This item is not applicable to the company - Not applicable[317] Other Information The company reported no other information for this item - None[318] Exhibits This section lists the exhibits filed with the Form 10-Q, which include CEO and CFO certifications as required by the Sarbanes-Oxley Act (Rules 13a-14(a) and Section 1350) and XBRL data files - The exhibits filed include certifications from the Chief Executive Officer and Chief Financial Officer[319] - XBRL Instance Documents and related taxonomy files were also submitted as exhibits[319]